Medicare Program: Changes to the Medicare Claims and Entitlement, Medicare Advantage Organization Determination, and Medicare Prescription Drug Coverage Determination Appeals Procedures, 43789-43891 [2016-15192]
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Vol. 81
Tuesday,
No. 128
July 5, 2016
Part III
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
42 CFR Parts 401, 405, 422, et al.
Medicare Program: Changes to the Medicare Claims and Entitlement,
Medicare Advantage Organization Determination, and Medicare Prescription
Drug Coverage Determination Appeals Procedures; Proposed Rule
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Federal Register / Vol. 81, No. 128 / Tuesday, July 5, 2016 / Proposed Rules
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
42 CFR Parts 401, 405, 422, 423, and
478
[HHS–2015–49]
RIN 0991–AC02
Medicare Program: Changes to the
Medicare Claims and Entitlement,
Medicare Advantage Organization
Determination, and Medicare
Prescription Drug Coverage
Determination Appeals Procedures
Centers for Medicare &
Medicaid Services, HHS.
ACTION: Proposed rule.
AGENCY:
This proposed rule would
revise the procedures that the
Department of Health and Human
Services would follow at the
Administrative Law Judge level for
appeals of payment and coverage
determinations for items and services
furnished to Medicare beneficiaries,
enrollees in Medicare Advantage and
other Medicare competitive health
plans, and enrollees in Medicare
prescription drug plans, as well as
appeals of Medicare beneficiary
enrollment and entitlement
determinations, and certain Medicare
premium appeals. In addition, this
proposed rule would revise procedures
that the Department of Health and
Human Services would follow at the
Centers for Medicare & Medicaid
Services (CMS) and the Medicare
Appeals Council (Council) levels of
appeal for certain matters affecting the
Administrative Law Judge level.
DATES: To be assured consideration,
comments must be received at one of
the addresses provided below, no later
than 5 p.m. eastern standard time (e.s.t.)
on August 29, 2016.
ADDRESSES: In commenting, refer to
‘‘HHS–2015–49’’ at the top of your
comments. Because of staff and resource
limitations, we cannot accept comments
by facsimile (FAX) transmission. We
will not accept comments submitted
after the comment period.
You may submit comments in one of
two ways (to ensure that we do not
receive duplicate copies, please choose
only one of the ways listed):
1. Electronically. You may submit
electronic comments on this proposed
rule at www.regulations.gov. For new
users, you can find instructions on how
to find a proposed rule and submit
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SUMMARY:
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comments under the ‘‘Help’’ tab at
www.regulations.gov.
If you are submitting comments
electronically, we strongly encourage
you to submit any comments or
attachments in Microsoft Word format.
If you must submit a comment in
Portable Document Format (PDF), we
strongly encourage you to convert the
PDF to print-to-PDF format or to use
some other commonly used searchable
text format. Please do not submit the
PDF in a scanned or read-only format.
Using a print-to-PDF format allows us to
electronically search and copy certain
portions of your submissions.
2. U.S. Mail or commercial delivery.
You may send written comments to the
following address ONLY: Office of
Medicare Hearings and Appeals,
Department of Health and Human
Services, Attention: HHS–2015–49,
5201 Leesburg Pike, Suite 1300, Falls
Church, VA 22041.
Please allow sufficient time for mailed
comments to be received before the
close of the comment period.
Privacy Note: Because comments will
be made available for public viewing in
their entirety on the Federal
eRulemaking portal, commenters should
exercise caution and only include in
their comments information that they
wish to make publicly available.
For information on viewing public
comments, see the beginning of the
SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT:
Rita Wurm, (410) 786–1139 (for issues
related to CMS appeals policies and
reopening policies).
Jason Green, (571) 777–2723 (for
issues related to Administrative Law
Judge appeals policies).
Debbie Nobleman, (202) 565–0139 (for
issues related to Council appeals
policies).
SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: All
comments received before the close of
the comment period are available for
viewing by the public, including any
personally identifiable or confidential
business information that is included in
a comment. We will post all comments
received before the close of the
comment period on the following Web
site as soon as possible after they have
been received: www.regulations.gov.
Follow the search instructions on that
Web site to view public comments.
Comments received timely will also
be available for public inspection as
they are received, generally beginning
approximately 4 weeks after publication
of a document, at the headquarters of
the Office of Medicare Hearings and
Appeals, 1700 North Moore Street, Suite
PO 00000
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1650, Arlington, Virginia 22209,
Monday through Friday of each week
from 8:30 a.m. to 4:00 p.m. To schedule
an appointment to view public
comments, phone (703) 235–0635.
Abbreviations
Because we refer to a number of terms
by abbreviation or a shortened form in
this proposed rule, we are listing these
abbreviations and shortened forms, and
their corresponding terms in
alphabetical order below:
Act—Social Security Act
ALJ—Administrative Law Judge
APA—Administrative Procedures Act
BIPA—Medicare, Medicaid, and SCHIP
Benefits Improvement and Protection Act
of 2000 (Pub. L. 106–554)
CMS—Centers for Medicare & Medicaid
Services
Council—Medicare Appeals Council
DAB—Departmental Appeals Board
HHS—U.S. Department of Health and Human
Services
IRE—Independent Review Entity
IRMAA—Income Related Monthly
Adjustment Amount
MA—Medicare Advantage
MAO—Medicare Advantage Organization
MMA—Medicare Prescription Drug,
Improvement, and Modernization Act of
2003 (Pub. L. 108–173)
OIG—HHS Office of Inspector General
OMHA—Office of Medicare Hearings and
Appeals
QIC—Qualified Independent Contractor
QIO—Quality Improvement Organization
SSA—Social Security Administration
Section 1557 of the Affordable Care Act
Independent of the standards
proposed in this rule, the Department
commits to complying with section
1557 of the Affordable Care Act, Public
Law 111–148, 124 Stat. 470 (42 U.S.C.
18116), which prohibits discrimination
on the basis of race, color, national
origin, sex, age, or disability in certain
health programs and activities. HHS
issued a proposed rule to implement
section 1557, Nondiscrimination in
Health Programs and Activities, on
September 8, 2015. 80 FR 54172. The
proposed rule would apply, in part, to
health programs and activities
administered by the Department.
Table of Contents
I. Background
II. General Provisions of the Proposed
Regulations
A. Precedential Final Decisions of the
Secretary
B. Attorney Adjudicators
C. Application of 405 Rules to Other Parts
D. OMHA References
E. Medicare Appeals Council References
III. Specific Provisions of the Proposed Rule
A. Provisions of Part 405, subpart I and
Part 423, subparts M and U
1. Overview
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2. General provisions, reconsiderations,
reopenings, and expedited access to
judicial review
a. Part 423, subpart M general provisions
(§ 423.562)
b. Part 423, subpart U title and scope
(§ 423.1968)
c. Medicare initial determinations,
redeterminations and appeals general
description (§ 405.904)
d. Parties to the initial determinations,
redeterminations, reconsiderations
proceedings on a request for hearing, and
Council review (§ 405.906)
e. Medicaid State agencies (§ 405.908)
f. Appointed representatives (§ 405.910)
g. Actions that are not initial
determinations (§ 405.926)
h. Notice of a redetermination (§ 405.956)
i. Time frame for making a reconsideration
following a contractor redetermination,
withdrawal or dismissal of a request for
a reconsideration, and reconsideration
(§§ 405.970, 405.972, and 405.974)
j. Notice of reconsideration (§ 405.976)
k. Effect of a reconsideration (§ 405.978)
l. Reopenings (§§ 405.980, 405.982,
405.984, 423.1978, 423.1980, 423.1982,
and 423.1984)
m. Expedited access to judicial review
(§§ 405.990 and 423.1990)
3. ALJ hearings
a. Hearing before an ALJ and decision by
an ALJ and attorney adjudicator: General
rule (§§ 405.1000 and 423.2000)
b. Right to an ALJ hearing (§§ 405.1002 and
423.2002)
c. Right to a review of QIC or IRE notice
of dismissal (§§ 405.1004 and 423.2004)
d. Amount in controversy required for an
ALJ hearing (§§ 405.1006 and 423.1970)
e. Parties to an ALJ hearing (§§ 405.1008
and 423.2008)
f. CMS and CMS contractors as participants
or parties in the adjudication process
(§§ 405.1010, 405.1012, and 423.2010)
i. Section 405.1010: When CMS or its
contractors may participate in the
proceedings on a request for an ALJ
hearing
ii. Section 423.2010: When CMS, the IRE,
or Part D plan sponsors may participate
in the proceedings on a request for an
ALJ hearing
iii. Section 405.1012: When CMS or its
contractors may be a party to a hearing
g. Request for an ALJ hearing or review of
a QIC or an IRE dismissal (§§ 405.1014,
423.1972 and 423.2014)
i. Requirements for a request for hearing or
review of a QIC or an IRE dismissal
ii. Requests for hearing involving statistical
sampling and extrapolations
iii. Opportunity to cure defective filings
iv. Where and when to file a request for
hearing or review of a QIC or an IRE
dismissal
v. Sending copies of a request for hearing
and other evidence to other parties to the
appeal
vi. Extending time to file a request for
hearing or review of a QIC or an IRE
dismissal
h. Time frames for deciding an appeal of
a QIC or an IRE reconsideration or an
escalated request for a QIC
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reconsideration, and request for Council
review when an ALJ does not issue a
decision timely (§§ 405.1016, 405.1104
and 423.2016)
i. Section 405.1016: Time frames for
deciding an appeal of a QIC or an
escalated request for a QIC
reconsideration
ii. Section 405.1104: Request for Council
review when an ALJ does not issue a
decision timely
iii. Section 423.2016: Time frames for
deciding an appeal of an IRE
reconsideration
i. Submitting evidence (§§ 405.1018 and
423.2018)
j. Time and place for a hearing before an
ALJ (§§ 405.1020 and 423.2020)
k. Notice of a hearing before an ALJ and
objections to the issues (§§ 405.1022,
405.1024, 423.2022, and 423.2024)
l. Disqualification of the ALJ or attorney
adjudicator (§§ 405.1026 and 423.2026)
m. Review of evidence submitted by the
parties (§ 405.1028)
n. ALJ hearing procedures (§§ 405.1030
and 423.2030)
o. Issues before an ALJ or attorney
adjudicator (§§ 405.1032, 405.1064 and
423.2032)
p. Requesting information from the QIC or
IRE, and remanding an appeal
(§§ 405.1034, 405.1056, 405.1058,
423.2034, 423.2056, and 423.2058)
q. Description of the ALJ hearing process
and discovery (§§ 405.1036, 405.1037,
and 423.2036)
r. Deciding a case without a hearing before
an ALJ (§§ 405.1038 and 423.2038)
s. Prehearing and posthearing conferences
(§§ 405.1040 and 423.2040)
t. The administrative record (§§ 405.1042
and 423.2042)
u. Consolidated proceedings (§§ 405.1044
and 423.2044)
v. Notice of decision and effect of an ALJ’s
or attorney adjudicator’s decision
(§§ 405.1046, 405.1048, 423.2046, and
423.2048)
w. Removal of a hearing request from an
ALJ to the Council (§§ 405.1050 and
423.2050)
x. Dismissal of a request for hearing or
request for review and effect of a
dismissal of a request for hearing or
request for review (§§ 405.1052,
405.1054, 423.2052 and 423.2054)
4. Applicability of Medicare coverage
policies (§§ 405.1060, 405.1062,
405.1063, 423.2062, and 423.2063)
5. Council review and judicial review
a. Council review: general (§§ 405.1100,
423.1974 and 423.2100)
b. Request for Council review when ALJ
issues decision or dismissal (§§ 405.1102
and 423.2102)
c. Where a request for review or escalation
may be filed (§§ 405.1106 and 423.2106)
d. Council actions when request for review
or escalation is filed (§§ 405.1108 and
423.2108)
e. Council reviews on its own motion
(§§ 405.1110 and 423.2110).
f. Content of request for review
(§§ 405.1112 and 423.2112).
g. Dismissal of request for review
(§§ 405.1114 and 423.2114)
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h. Effect of dismissal of request for Council
review or request for hearing
(§§ 405.1116 and 423.2116)
i. Obtaining evidence from the Council
(§§ 405.1118 and 423.2118)
j. What evidence may be submitted to the
Council (§§ 405.1122 and 423.2122)
k. Case remanded by the Council
(§§ 405.1126 and 423.2126)
l. Action of the Council (§§ 405.1128 and
423.2128)
m. Request for escalation to Federal court
(§ 405.1132)
n. Judicial review (§§ 405.1136, 423.1976,
and 423.2136)
o. Case remanded by a Federal court
(§§ 405.1038 and 423.2138)
p. Council review of ALJ decision in a case
remanded by a Federal district court
(§§ 405.1140 and 423.2140)
B. Part 405, subpart J expedited
reconsiderations (§ 405.1204)
C. Part 422, subpart M
1. General provisions (§ 422.562).
2. Notice of reconsidered determination by
the independent entity (§ 422.594).
3. Request for an ALJ hearing (§ 422.602).
4. Medicare Appeals Council (Council)
review (§ 422.608).
5. Judicial review (§ 422.612)
6. Reopening and revising determinations
and decisions (§ 422.616)
7. How an MA organization must effectuate
standard reconsideration determinations
and decisions, and expedited
reconsidered determinations (§§ 422.618
and 422.619)
8. Requesting immediate QIO review of the
decision to discharge from the inpatient
hospital and fast-track appeals of service
terminations to independent review
entities (IREs) (§§ 422.622 and 422.626).
D. Part 478, subpart B
1. Applicability and beneficiary’s right to
a hearing (§§ 478.14 and 478.40)
2. Submitting a request for a hearing
(§ 478.42)
3. Determining the amount in controversy
(§ 478.44)
4. Medicare Appeals Council and judicial
review (§ 478.46)
5. Reopening and revision of a
reconsidered determination or a decision
(§ 478.48)
IV. Collection of Information Requirements
V. Response to Comments
VI. Regulatory Impact Statement
VII. Federal Analysis
I. Background
In accordance with provisions of
sections 1155, 1852, 1860D–4, 1869, and
1876 of the Act, and their implementing
regulations, there are multiple
administrative appeal processes for
Medicare fee-for-service (Part A and Part
B) claim, entitlement and certain
premium initial determinations;
Medicare Advantage (Part C) and other
competitive health plan organization
determinations; and Part D plan sponsor
coverage determinations and certain
premium determinations. The first, and
in many instances a second, level of
administrative appeal are administered
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by Medicare contractors, Part D plan
sponsors, Medicare Advantage
organizations or Medicare plans, or by
the SSA. For example, under section
1869 of the Act, the Medicare claims
appeal process involves
redeterminations conducted by the
Medicare Administrative Contractors
(which are independent of the staff that
made the initial determination)
followed by reconsiderations conducted
by QICs. However, all of the appeals
discussed in this proposed regulation
could be appealed to the ALJs at OMHA
if the amount in controversy
requirement and other requirements are
met after these first and/or second levels
of appeal.
OMHA, a staff division within the
Office of the Secretary of HHS,
administers the nationwide ALJ hearing
program for Medicare claim,
organization and coverage
determination, and entitlement and
certain premium appeals. If the amount
in controversy and other filing
requirements are met, a hearing before
an ALJ is available following a QIO
reconsidered determination under
section 1155 of the Act; an SSA or QIC
reconsideration, or a request for QIC
reconsideration for which a decision is
not issued timely and a party requests
escalation of the matter under section
1869(b)(1)(A) and (d) of the Act (Part A
and Part B appeals); an IRE
reconsideration or QIO reconsidered
determination under sections
1876(c)(5)(B) or 1852(g)(5) of the Act
(Part C and other managed health plan
appeals); or an IRE reconsideration
under section 1860D–4(h) of the Act
(Part D appeals). In addition, under
current regulations a review by an ALJ
is available following a dismissal of a
request for reconsideration, if the
amount in controversy and other filing
requirements are met.
OMHA provides Medicare
beneficiaries and the providers and
suppliers that furnish items or services
to Medicare beneficiaries, as well as
applicable plans, MAOs, and Medicaid
State agencies with a fair and impartial
forum to address disagreements
regarding: Medicare coverage and
payment determinations made by
Medicare contractors, MAOs, or Part D
plan sponsors; and determinations
related to Medicare beneficiary
eligibility and entitlement, Part B late
enrollment penalties, and IRMAAs,
which apply to Medicare Part B and Part
D premiums, made by SSA. Further
review of OMHA ALJ decisions, except
decisions affirming a dismissal of a
request for reconsideration, is available
from the Medicare Appeals Council
(Council) within the DAB, a staff
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division within the Office of the
Secretary of HHS. Judicial review is
then available for Council decisions in
Federal courts, if the amount in
controversy and other requirements are
met.
OMHA ALJs began adjudicating
appeals in July 2005, based on section
931 of the MMA, which required the
transfer of responsibility for the ALJ
hearing level of the Medicare claim and
entitlement appeals process from SSA to
HHS. New rules at 42 CFR part 405,
subpart I and subpart J were also
established to implement statutory
changes to the Medicare fee-for-service
(Part A and Part B) appeals process
made by BIPA in 2000 and the MMA in
2003. Among other things, these new
rules addressed appeals of
reconsiderations made by QICs, which
were created by BIPA for the Part A and
Part B programs. These rules also apply
to appeals of SSA reconsiderations. The
statutory changes made by BIPA
included a 90-day adjudication time
frame for ALJs to adjudicate appeals of
QIC reconsiderations beginning on the
date that a request for an ALJ hearing is
timely filed. The new part 405, subpart
I rules were initially proposed in the
November 15, 2002 Federal Register (67
FR 69312) (2002 Proposed Rule) to
implement BIPA, and were
subsequently implemented in an
interim final rule with comment period,
which also set forth new provisions to
implement the MMA, in the March 8,
2005 Federal Register (70 FR 11420)
(2005 Interim Final Rule). Correcting
amendments to the 2005 Interim Final
Rule were published in the June 30,
2005 Federal Register (70 FR 37700)
(2005 Correcting Amendment I) and in
the August 26, 2005 Federal Register
(70 FR 50214) (2005 Correcting
Amendment II), and the final rule was
published in the December 9, 2009
Federal Register (74 FR 65296) (2009
Final Rule). Subsequent revisions to
part 405, subpart I to implement the
Strengthening Medicare and Repaying
Taxpayers Act of 2012 (SMART Act,
Pub. L. 112–242) were published in the
February 27, 2015 Federal Register (80
FR 10611) (SMART Act Final Rule).
In addition to the part 405, subpart I
rules, OMHA applies the rules at 42
CFR part 478, subpart B to individuals’
appeals of QIO reconsidered
determinations; part 422, subpart M to
appeals of IRE reconsiderations or QIO
reconsidered determinations under the
Medicare Advantage (Part C) and other
competitive health plan programs; and
part 423, subpart U to appeals of IRE
reconsiderations under the Medicare
prescription drug (Part D) program.
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In recent years, the Medicare appeals
process has experienced an
unprecedented and sustained increase
in the number of appeals. At OMHA, for
example, the number of requests for an
ALJ hearing or review increased 1,222
percent, from fiscal year (FY) 2009
through FY 2014. The increasing
number of requests has strained
OMHA’s available resources and
resulted in delays for appellants to
obtain hearings and decisions.
Despite significant gains in OMHA
ALJ productivity (in FY 2014, each
OMHA ALJ issued, on average, a record
1,048 decisions and an additional 456
dismissals), and CMS and OMHA
initiatives to address the increasing
number of appeals, the number of
requests for an ALJ hearing and requests
for reviews of QIC and IRE dismissals
continue to exceed OMHA’s capacity to
adjudicate the requests. As of April 30,
2016, OMHA had over 750,000 pending
appeals, while OMHA’s adjudication
capacity was 77,000 appeals per year,
with an additional adjudication capacity
of 15,000 appeals per year expected by
the end of Fiscal Year 2016.
HHS has a three-prong approach to
addressing the increasing number of
appeals and the current backlog of
claims waiting to be adjudicated at
OMHA: (1) Request new resources to
invest at all levels of appeal to increase
adjudication capacity and implement
new strategies to alleviate the current
backlog; (2) take administrative actions
to reduce the number of pending
appeals and implement new strategies
to alleviate the current backlog ; and (3)
propose legislative reforms that provide
additional funding and new authorities
to address the volume of appeals. In this
notice of proposed rulemaking, HHS is
pursuing the three-prong approach by
proposing rules that would expand the
pool of available OMHA adjudicators
and improve the efficiency of the
appeals process by streamlining the
processes so less time is spent by
adjudicators and parties on repetitive
issues and procedural matters.
II. General Provisions of the Proposed
Regulations
A. Precedential Final Decisions of the
Secretary
Council decisions are binding on the
parties to that particular appeal and are
the final decisions of the Secretary from
which judicial review may be sought
under section 205(g) of the Act, in
accordance with current §§ 405.1130,
422.612(b), 423.2130, and 478.46(b). As
explained in the 2009 Final Rule (74 FR
65307 through 65308), ‘‘binding’’
indicates the parties are obligated to
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abide by the adjudicator’s action or
decision unless further recourse is
available and a party exercises that
right. ‘‘Final’’ indicates that no further
administrative review of the decision is
available and judicial review may be
immediately sought.
In 1999, the OIG issued a report
entitled ‘‘Medicare Administrative
Appeals—ALJ Hearing Process’’ (OEI–
04–97–00160) (Sept. 1999) (https://
oig.hhs.gov/oei/reports/oei-04-9700160.pdf). In that report, the OIG noted
that the DAB respondents voiced strong
interest in having precedent setting
authority in the Medicare administrative
appeals process ‘‘to clean-up
inconsistencies in the appeals process.’’
The OIG recommended that such a case
precedent system be established.
Pursuant to section 931(a) of the
MMA, HHS and SSA developed a plan
for the transition of the ALJ hearing
function for some types of Medicare
appeals from SSA to HHS, and
addressed the feasibility of precedential
authority of DAB decisions. See Report
to Congress: Plan for the Transfer of
Responsibility for Medicare Appeals
(Mar. 2004) (https://www.ssa.gov/
legislation/medicare/medicare_appeal_
transfer.pdf). HHS determined that at
that time, it was not feasible or
appropriate to confer precedential
authority on Council decisions, but
indicated that it would reevaluate the
merits of granting precedential authority
to some or all Council decisions after
the BIPA and MMA changes to the
appeals process were fully
implemented.
BIPA and MMA changes to the
appeals process have now been fully
implemented and we believe it is
appropriate to propose that select
Council decisions be made precedential
to increase consistency in decisions at
all levels of appeal for appellants.
Proposed § 401.109 would introduce
precedential authority to the Medicare
claim and entitlement appeals process
under part 405, subpart I; part 422,
subpart M; part 423, subparts M and U;
and part 478, subpart B. Proposed
§ 401.109(a) would grant authority to
the Chair of the DAB to designate a final
decision of the Secretary issued by the
Council as precedential. We believe this
would provide appellants with a
consistent body of final decisions of the
Secretary upon which they could
determine whether to seek appeals. It
would also assist appeal adjudicators at
all levels of appeal by providing clear
direction on repetitive legal and policy
questions, and in limited circumstances,
factual questions. In the limited
circumstances in which a precedential
decision would apply to a factual
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question, the decision would be binding
where the relevant facts are the same
and evidence is presented that the
underlying factual circumstances have
not changed since the Council issued
the precedential final decision.
It is appropriate for the DAB Chair to
have the role of designating select
Council decisions as precedential. The
DAB Chair leads the DAB, which was
established in 1973. The DAB has wide
jurisdiction over disputes arising under
many HHS programs and components,
and has issued precedential decisions
for many years within several of its
areas of jurisdiction. (Examples of DAB
jurisdiction may be found at 45 CFR
part 16, 42 CFR part 498, 42 CFR part
426, and on the DAB’s Web site at
www.hhs.gov/dab.) The Council has
been housed within the DAB as an
organization since 1995 and is itself also
under the leadership of the DAB Chair.
Thus, the DAB Chair brings both
expertise in the Medicare claims
appeals over which the Council has
jurisdiction and experience from the
DAB’s precedential cases to carrying out
the role of designating Council
decisions to be precedential. Moreover,
having the designation performed by the
DAB Chair respects the continued
independence of the Council as an
adjudicative body by allowing the DAB
to determine the effect of its own
decisions. Limiting binding precedential
effect to selected decisions provides the
necessary discretion to designate as
precedential those Council decisions in
which a significant legal or factual issue
was fully developed on the record and
thoroughly analyzed. Designation might
not be appropriate where an issue was
mentioned in the decision as relevant
but was not outcome determinative, and
therefore may not have been as fully
developed as is necessary for
precedential decisions or where the
issues addressed are not likely to have
broad application beyond the particular
case.
To help ensure appellants and other
stakeholders are aware of Council
decisions that are designated as
precedential, we are proposing that
§ 401.109(b) would require notice of
precedential decisions to be published
in the Federal Register, and the
decisions themselves would be made
available to the public, with necessary
precautions taken to remove personally
identifiable information that cannot be
disclosed without the individual’s
consent. Designated precedents would
be posted on an accessible Web site
maintained by HHS. Decisions of the
Council would bind all lower-level
decision-makers from the date that the
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decisions are posted on the HHS Web
site.
Proposed § 401.109(c) would make
these precedential decisions binding on
all CMS components, on all HHS
components that adjudicate matters
under the jurisdiction of CMS, and on
SSA to the extent that SSA components
adjudicate matters under the
jurisdiction of CMS, in the same manner
as CMS Rulings under current
§ 401.108. That means the precedential
decision would be binding on CMS and
its contractors in making initial
determinations, redeterminations, and
reconsiderations, under part 405 subpart
I, or equivalent determinations under
parts 422 subpart M, 423 subparts M
and U, and 478 subpart B; OMHA ALJs
and, as proposed in II.B below, attorney
adjudicators; the Council in its future
decisions; and SSA to the extent that it
adjudicates matters under the
jurisdiction of CMS. Individual
determinations and decisions by CMS
contractors, OMHA ALJs, and the
Council currently are not precedential
and have no binding effect on future
initial determinations (and equivalent
determinations) or claims appeals. We
are not proposing to change the nonprecedential status and non-binding
effect on future initial determinations
(and equivalent determinations) or
claim appeals of any determinations or
decisions except as to Council decisions
designated as precedential by the DAB
Chair.
Proposed § 401.109(d) would specify
the scope of the precedential effect of a
Council decision designated by the DAB
Chair. The Council’s legal analysis and
interpretation of an authority or
provision that is binding (see, for
example §§ 405.1060 and 405.1063) or
owed substantial deference (see, for
example § 405.1062) would be binding
in future determinations and appeals in
which the same authority or provision
is applied and is still in effect. However,
if CMS revises the authority or
provision that is the subject of a
precedential decision, the Council’s
legal analysis and interpretation would
not be binding on claims or other
disputes to which the revised authority
or provision applies. For example, if a
Council decision designated as
precedential by the DAB Chair
interprets a CMS manual instruction,
that interpretation would be binding on
pending and future appeals and initial
determinations to which that manual
instruction applies. However, CMS
would be free to follow its normal
internal process to revise the manual
instruction at issue. Once the revised
instruction is issued through the CMS
process, the revised instruction would
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apply to making initial determinations
on all claims thereafter. This would
help ensure that CMS continues to have
the ultimate authority to administer the
Medicare program and promulgate
regulations, and issue sub-regulatory
guidance and policies on Medicare
coverage and payment.
If the decision is designated as
precedential by the DAB Chair,
proposed § 401.109(d) would also make
the Council’s findings of fact binding in
future determinations and appeals that
involve the same parties and evidence.
For example, if a precedential Council
decision made findings of fact related to
the issue of whether an item qualified
as durable medical equipment and the
same issue was in dispute in another
appeal filed by the same party, and that
party submitted the same evidence to
support its assertion, the findings of fact
in the precedential Council decision
would be binding. However, we note
that many claim appeals turn on
evidence of a beneficiary’s condition or
care at the time discrete items or
services are furnished, and therefore
proposed § 401.109 is unlikely to apply
to findings of fact in these appeals.
In addition, consistent with proposed
§ 401.109, we are proposing at
§ 405.968(b)(1) to add precedential
decisions designated by the Chair of the
Departmental Appeals Board as an
authority that is binding on the QIC. We
are also proposing at §§ 405.1063 and
423.2063, which currently cover the
applicability of laws, regulations, and
CMS Rulings, to add new paragraph (c)
to the sections to provide that
precedential decisions designated by the
Chair of the Departmental Appeals
Board in accordance with § 401.109 are
binding on all CMS components, all
HHS components that adjudicate
matters under the jurisdiction of CMS,
and on the Social Security
Administration to the extent that
components of the Social Security
Administration adjudicate matters
under the jurisdiction of CMS. Finally,
we are proposing to add precedential
decisions to the titles of §§ 405.1063 and
423.2063 to reflect the additional topic
covered by proposed paragraph (c).
We are inviting public comments on
these proposals. If you choose to
comment on the proposals in this
section, please include the caption
‘‘Precedential final decisions of the
Secretary’’ at the beginning of your
comment.
B. Attorney Adjudicators
Sections 1155, 1852(g)(5), 1860D–
4(h), 1869(b)(1)(A), and 1876(c)(5)(B)
provide a right to a hearing to the same
extent as provided in section 205(b) by
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the HHS Secretary for certain appealable
decisions by Medicare contractors or
SSA, when the amount in controversy
and other filing requirements are met.
Hearings under these statutory
provisions are conducted by OMHA
ALJs with delegated authority from the
HHS Secretary, in accordance with
these sections and the APA.
Under current §§ 405.1038 and
423.2038, OMHA ALJs are also
responsible for a portion of the appeals
workload that does not require a hearing
because a request for an ALJ hearing
may also be addressed without
conducting a hearing. For example,
under §§ 405.1038 and 4423.2038, if the
evidence in the hearing record supports
a finding in favor of the appellant(s) on
every issue, or if all parties agree in
writing that they do not wish to appear
before the ALJ at a hearing, the ALJ may
issue a decision on the record without
holding a hearing. Under current
§§ 405.1052(a)(1) and 423.2052(a)(1),
OMHA ALJs must also address a large
number of requests to withdraw
requests for ALJ hearings, which
appellants often file pursuant to
litigation settlements, law enforcement
actions, and administrative agreements
in which they agree to withdraw
appeals and not seek further appeals of
resolved claims. In addition, pursuant to
§§ 405.1004 and 423.2004, OMHA ALJs
review whether a QIC or IRE dismissal
was in error. Under these sections, the
ALJ reviews the dismissal, but no
hearing is required. In FY 2015, OMHA
ALJs addressed approximately 370
requests to review whether a QIC or IRE
dismissal was in error. Also adding to
the ALJs’ workload are remands to
Medicare contractors for information
that can only be provided by CMS or its
contractors under current §§ 405.1034(a)
and 423.2034(a), and for further case
development or information at the
direction of the Council. Staff may
identify the basis for these remands
before an appeal is assigned to an ALJ
and a remand order is prepared, but an
ALJ must review the appeal and issue
the remand order, taking the ALJ’s time
and attention away from hearings and
making decision on the merits of
appeals.
Under section 1869(d) of the Act, an
ALJ must conduct and conclude a
hearing on a decision of a QIC under
subsection (c). Subsection (c) of section
1869 of the Act involves the conduct of
reconsiderations by QICs. We believe
that the statute does not require the
action to be taken by an ALJ in cases
where there is no QIC reconsideration
(for example, where the QIC has issued
a dismissal), or in cases of a remand or
a withdrawal of a request for an ALJ
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hearing, and therefore the findings of
fact and conclusions of law need not be
rendered. ALJ hearings are ideally
suited to obtain testimony and other
evidence, and hear arguments related to
the merits of a claim or other
determination on appeal. ALJs are
highly qualified to conduct those
hearings and make findings of fact and
conclusions of law to render a decision
in the more complex records presented
with a mix of documentary and
testimonial evidence. However, welltrained attorneys can perform a review
of the administrative record and more
efficiently draft the appropriate order
for certain actions, such as issuing
dismissals based on an appellant’s
withdrawal of a request for an ALJ
hearing, remanding appeals for
information or at the direction of the
Council, and conducting reviews of QIC
and IRE dismissals.
In addition, current §§ 405.1038 and
423.2038 provide mechanisms for
deciding cases without an oral hearing,
based on the written record. Cases may
be decided without an oral hearing
when the record supports a finding in
favor of the appellant(s) on every issue;
all of the parties have waived the oral
hearing in writing; or the appellant lives
outside of the United States and did not
inform the ALJ that he or she wishes to
appear, and there are no other parties
who wish to appear. In these
circumstances, the need for an
experienced adjudicator knowledgeable
in Medicare coverage and payment law
continues, and well-trained attorneys
can review the record, identify the
issues, and make the necessary findings
of fact and conclusions of law when the
regulations do not require a hearing to
issue a decision in the appealed matter.
To enable OMHA to manage requests
for an ALJ hearing and requests for
reviews of QIC and IRE dismissals in a
more timely manner and increase
service to appellants, while preserving
access to a hearing before an ALJ in
accordance with the statutes, we are
proposing to revise rules throughout
part 405, subparts I and J; part 422,
subpart M; part 423, subparts M and U;
and part 478, subpart B, to provide
authority that would allow attorney
adjudicators to issue decisions when a
decision can be issued without an ALJ
conducting a hearing under the
regulations, dismissals when an
appellant withdraws his or her request
for an ALJ hearing, and remands for
information that can only be provided
by CMS or its contractors or at the
direction of the Council; as well as to
conduct reviews of QIC and IRE
dismissals. We also are proposing to
revise the rules so that decisions and
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dismissals issued by attorney
adjudicators may be reopened and/or
appealed in the same manner as
equivalent decisions and dismissals
issued by ALJs. Allowing attorney
adjudicators to issue decisions,
dismissals, and remands as described
above, and to conduct reviews of QIC
and IRE dismissals would expand the
pool of OMHA adjudicators and allow
ALJs to focus on cases going to a
hearing, while still providing appellants
with quality reviews and decisions,
dismissals, and remands. In addition,
the rights associated with an appeal
adjudicated by an ALJ would extend to
any appeal adjudicated by an attorney
adjudicator, including any applicable
adjudication time frame, escalation
option, and/or right of appeal to the
Council.
In addition, we note that even if an
attorney adjudicator was assigned to
adjudicate a request for an ALJ hearing,
that hearing request still could be
reassigned to an ALJ for an oral hearing
if the attorney adjudicator determined
that a hearing could be necessary to
render a decision. For example, if the
parties waived their rights to an oral
hearing in writing, allowing a decision
to be issued without conducting an oral
hearing in accordance with current
§§ 405.1038(b)(1) or 423.2038(b)(1), but
the attorney adjudicator believed
testimony by the appellant or another
party would be necessary to decide the
appeal, the attorney adjudicator would
refer the appeal to an ALJ to determine
whether conducting an oral hearing
would be necessary to decide the appeal
regardless of the waivers, pursuant to
current §§ 405.1036(b)(3) or
423.2036(b)(3). We also note that parties
to a decision that is issued without an
ALJ conducting an oral hearing
pursuant to current §§ 405.1038(a) or
423.2038(a) (that is, the decision is
favorable to the appellant on every issue
and therefore may be issued based on
the record alone) continue to have a
right to a hearing and a right to examine
the evidence on which the decision is
based and may pursue that right by
requesting a review of the decision by
the Council, which can remand the case
for an ALJ to conduct a hearing and
issue a new decision.
To implement this proposal, we are
proposing to revise provisions
throughout part 405 subpart I, part 422
subpart M, part 423 subparts M and U,
and part 478 subpart U, as detailed in
proposed revisions to specific sections,
in section III of this proposed rule,
below. In addition, we are proposing to
define an attorney adjudicator in
§ 405.902, which provides definitions
that apply to part 405 subpart I. We are
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proposing to define an ‘‘attorney
adjudicator’’ in § 405.902 as a licensed
attorney employed by OMHA with
knowledge of Medicare coverage and
payment laws and guidance. In
addition, we are proposing to indicate
in § 405.902 that the attorney
adjudicator is authorized to take the
actions provided for in subpart I on
requests for ALJ hearing and requests for
reviews of QIC dismissals. These
proposals would provide the public
with an understanding of the attorney
adjudicator’s qualifications and scope of
authority, and we also note that attorney
adjudicators would receive the same
training as OMHA ALJs.
We are inviting public comments on
these proposals. If you choose to
comment on the proposals in this
section, please include the caption
‘‘Attorney Adjudicators’’ at the
beginning of your comment.
C. Application of 405 Rules to Other
Parts
Current § 422.562(d) states that unless
subpart M regarding grievances,
organization determinations and
appeals under the Medicare Advantage
program provides otherwise, the
regulations found in part 405 apply
under subpart M to the extent
appropriate. In addition, current
§ 422.608, which is a section within
subpart M, provides that the regulations
under part 405 regarding Council review
apply to the subpart to the extent that
they are appropriate.
Similar to current § 422.562(d),
§ 478.40(c) indicates that the part 405
regulations apply to hearings and
appeals under subpart B of part 478
regarding QIO reconsiderations and
appeals, unless they are inconsistent
with specific provisions in subpart B.
Thus, the part 405 rules are used, to the
extent appropriate, for administrative
review and hearing procedures in the
absence of specific provisions related to
administrative reviews and hearing
procedures in part 422, subpart M; and
part 478, subpart B, respectively. These
general references to part 405 are often
helpful in filling in gaps in procedural
rules when there is no rule on point in
the respective part. However, there has
been confusion on the application of
part 405 rules when a part 405 rule
implements a specific statutory
provision that is not in the authorizing
statute for the referring subpart and
HHS has not adopted a similar policy
for the referring subpart in its discretion
to administer the Medicare Advantage,
QIO, and cost plan appeals programs.
For example, certain procedures and
provisions of section 1869 of the Act
(governing certain determinations and
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appeals under Medicare Part A and Part
B) that are implemented in part 405,
subpart I are different than or not
addressed in sections 1155 (providing
for reconsiderations and appeals of QIO
determinations), 1852(g) (providing for
appeals of MA organization
determinations), and 1876 (providing
for appeals of organization
determinations made by section 1876
health maintenance organizations
(HMOs) and competitive medical plans
(CMPs). Section 1869 of the Act
provides for, among other things,
redeterminations of certain initial
determinations, QIC reconsiderations
following redeterminations or expedited
determinations; ALJ hearings and
decisions following a QIC
reconsideration; DAB review following
ALJ decisions; specific time frames in
which to conduct the respective
adjudications; and, at certain appeal
levels, the option to escalate appeals to
the next level of appeal if the
adjudication time frames are not met. In
addition, section 1869(b)(3) of the Act
does not permit providers and suppliers
to introduce evidence in an appeal
brought under section 1869 of the Act
after the QIC reconsideration, unless
there is good cause that precluded the
introduction of the evidence at or before
the QIC reconsideration.
In contrast, sections 1852(g)(5) of the
Act and 1876(c)(5)(B) of the Act
incorporate some, but not all, of the
provisions of section 1869 of the Act,
and add certain requirements, such as
making the MAO, HMO, or CMP a party
to an ALJ hearing. For example, sections
1852(g)(5) and 1876(c)(5)(B) of the Act
specifically incorporate section
1869(b)(1)(E)(iii) of the Act to align the
amount in controversy requirements for
an ALJ hearing and judicial review
among the three sections. However,
sections 1852(g) and 1876(c)(5)(B) do
not incorporate adjudication time
frames and escalation provisions, or the
limitation on new evidence provision of
section 1869(b)(3) of the Act.
Additionally, section 1155 of the Act
provides for an individual’s right to
appeal certain QIO reconsidered
determinations made under section
1154 of the Act directly to an ALJ for
hearing. However, section 1155 of the
Act does not reference section 1869 of
the Act or otherwise establish an
adjudication time frame, and provides
for a different amount in controversy
requirement for an ALJ hearing.
Despite these statutory distinctions,
HHS has established similar procedures
by regulation to the extent practicable,
when not addressed by statute. For
example, section 1860D–4(h) of the Act,
which addresses appeals of coverage
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determinations under Medicare Part D,
incorporates paragraphs (4) and (5) of
section 1852(g) of the Act. As discussed
above, section 1852(g) does not
incorporate adjudication time frames
from section 1869 of the Act or
otherwise establish such time frames.
However, through rulemaking for Part D
coverage determination appeals, HHS
has adopted a 90-day adjudication time
frame for standard requests for an ALJ
hearing and requests for Council review
of an ALJ decision, as well as a 10-day
adjudication time frame when the
criteria for an expedited hearing or
review are met.
To clarify the application of the part
405 rules, we are proposing revisions to
parts 422 and 478. Proposed
§§ 422.562(d) and 422.608 would
provide that the part 405 rules do not
apply when the part 405 rule
implements a statutory provision that is
not also applicable to section 1852 of
the Act. Similarly, proposed § 478.40(c)
would provide that the part 405 rules do
not apply when the part 405 rule
implements a statutory provision that is
not also applicable to section 1155 of
the Act. In addition, proposed
§ 478.40(c) removes language that
equates an initial determination and
reconsidered determination made by a
QIO to contractor initial determinations
and reconsidered determinations under
part 405 because that language has
caused confusion with provisions that
are specific to part 405 and QIC
reconsiderations, and it is not necessary
to apply the remaining part 405, subpart
I procedural rules in part 478, subpart
B proceedings. In addition to clarifying
the application of part 405 rules to other
parts, these revisions would help ensure
that statutory provisions that are
specific to certain Medicare appeals are
not applied to other appeals without
HHS first determining, through
rulemaking, whether it would be
appropriate to apply a provision and
how best to tailor aligning policies for
those other appeals.
We are inviting public comments on
these proposals. If you choose to
comment on the proposals in this
section, please include the caption
‘‘Application of part 405 rules to other
parts’’ at the beginning of your
comment.
D. OMHA References
When the 2005 Interim Final Rule
was published in March 2005,
implementing the part 405, subpart I
rules, OMHA was not yet in operation.
Further, processes and procedures were
being established under the part 405
subpart I rules, with new CMS
contractors and the newly transitioned
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ALJ hearing function. Since that time,
OMHA and CMS and its contractors
have developed operating arrangements
to help ensure appeals flow between
CMS contractors and OMHA, and that
appeal instructions for appellants
provide clear direction on how and
where to file requests for hearings and
reviews. However, many of the current
rules for the ALJ hearing program that
OMHA administers reflect the transition
that was occurring at the time of the
2005 Interim Final Rule, and OMHA is
not mentioned in the regulation text.
To provide clarity to the public on the
role of OMHA in administering the ALJ
hearing program, and to clearly identify
where requests and other filings should
be directed, we are proposing to define
OMHA in § 405.902 as the Office of
Medicare Hearings and Appeals within
the U.S. Department of Health and
Human Services, which administers the
ALJ hearing process in accordance with
section 1869(b)(1) of the Act. We are
also proposing to amend rules
throughout part 405, subparts I and J;
part 422, subpart M; part 423, subparts
M and U; and part 478, subpart B to
reference OMHA or an OMHA office, in
place of current references to an
unspecified entity, ALJs, and ALJ
hearing offices, when a reference to
OMHA or an OMHA office provides a
clearer explanation of a topic. To
implement this proposal, we are
proposing to revise provisions
throughout part 405 subparts I and J,
part 422 subpart M, part 423 subparts M
and U, and part 478 subpart U, as
detailed in proposed revisions to
specific sections, in section III of this
proposed rule, below.
We are inviting public comments on
these proposals. If you choose to
comment on the proposals in this
section, please include the caption
‘‘OMHA references’’ at the beginning of
your comment.
E. Medicare Appeals Council References
The Council is currently referred to as
the ‘‘MAC’’ throughout current part 405,
subpart I; part 422, subpart M; and part
423, subparts M and U. This reference
has caused confusion in recent years
with the transition from Fiscal
Intermediaries and Carriers, to Medicare
administrative contractors—for which
the acronym ‘‘MAC’’ is also commonly
used—to process claims and make
initial determinations and
redeterminations in the Medicare Part A
and Part B programs. In addition,
current §§ 422.618 and 422.619
reference the Medicare Appeals Council
but use ‘‘Board’’ as the shortened
reference, and part 478, subpart B,
references the DAB as the reviewing
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entity for appeals of ALJ decisions and
dismissals but the Council is the entity
that conducts reviews of ALJ decisions
and dismissals, and issues final
decisions of the Secretary for Medicare
appeals under part 478, subpart B.
To address potential confusion with
references to Medicare administrative
contractors and align references to the
Council as the reviewing entity for
appeals of ALJ decisions and dismissals
throughout part 405, subpart I; part 422,
subpart M; and part 423, subparts M and
U, we are proposing to amend the
following rules to replace ‘‘MAC’’ or
‘‘Board’’ with ‘‘Council’’: §§ 405.902,
405.904, 405.906, 405.908, 405.910,
405.926, 405.980, 405.982, 405.984,
405.990, 405.1026, 405.1036, 405.1037,
405.1042, 405.1046, 405.1048, 405.1050,
405.1052, 405.1054, 405.1060, 405.1063,
405.1062, 405.1100, 405.1102, 405.1104
(as re-designated and revised as
proposed § 405.1016(e)–(f)), 405.1106,
405.1108, 405.1110, 405.1112, 405.1114,
405.1116, 405.1118, 405.1120, 405.1122,
405.1124, 405.1126, 405.1128, 405.1130,
405.1132, 405.1134, 405.1136, 405.1138,
405.1140, 422.561, 422.562, 422.608,
422.612, 422.616, 422.618, 422.619,
422.622, 422.626, 423.560, 423.562,
423.1968, 423.1974, 423.1976, 423.1978,
423.1980, 423.1982, 423.1984, 423.1990,
423.2026, 423.2036, 423.2042, 423.2046,
423.2048, 423.2050, 423.2052, 423.2054,
423.2062, 423.2063, 423.2100, 423.2102,
423.2106, 423.2108, 423.2110, 423.2112,
423.2114, 423.2116, 423.2118, 423.2120,
423.2122, 423.2124, 423.2126, 423.2128,
423.2130, 423.2134, 423.2136, 423.2138,
and 423.2140.
In addition, to align references to the
Council as the reviewing entity for
appeals of ALJ decisions and dismissals
in part 478, subpart B, we are proposing
to amend §§ 478.46 and 478.48 to
replace ‘‘Departmental Appeals Board’’
and ‘‘DAB,’’ with ‘‘Medicare Appeals
Council’’ and ‘‘Council’’.
We are inviting public comments on
these proposals. If you choose to
comment on the proposals in this
section, please include the caption
‘‘Medicare Appeals Council references’’
at the beginning of your comment.
III. Specific Provisions of the Proposed
Rule
A. Provisions of Part 405, Subpart I and
Part 423, Subparts M and U
1. Overview
Part 405, subpart I and part 423,
subpart U contain detailed procedures
for requesting and adjudicating a
request for an ALJ hearing, and a request
for a review of a QIC or IRE dismissal.
Part 423, subpart U provisions were
proposed in the March 17, 2008 Federal
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Register (73 FR 14342) and made final
in the December 9, 2009 Federal
Register (74 FR 65340), and generally
follow the part 405, subpart I
procedures. In this proposed rule, we
generally discuss proposals related to
part 405, subpart I, and then whether
any aligning revisions to part 423,
subpart U, are proposed, unless a
provision is specific to Part 405 and
there is no corresponding part 423
provision.
2. General Provisions, Reconsiderations,
Reopenings, and Expedited Access to
Judicial Review
sradovich on DSK3GDR082PROD with PROPOSALS3
a. Part 423, Subpart M General
Provisions (§ 423.562)
Current § 423.562(b)(4) lists the
appeal rights of a Part D plan enrollee,
if the enrollee is dissatisfied with any
part of a coverage determination.
Specifically, paragraph (b)(4)(v)
describes the right to request Council
review of the ALJ’s hearing decision if
the ALJ affirms the IRE’s adverse
coverage determination in whole or in
part, and paragraph (b)(4)(vi) describes
the right to judicial review of the
hearing decision if the Council affirms
the ALJ’s adverse coverage
determination in whole or in part, and
the amount in controversy requirements
are met. We are proposing to revise
paragraph (b)(4)(v) to insert ‘‘or attorney
adjudicator’’ after each instance of ‘‘the
ALJ.’’ This proposal is necessary to
implement the proposal to allow
attorneys to adjudicate requests for an
ALJ hearing when no hearing is
conducted as proposed in section II.B
above, by stating the right to request
Council review of an attorney
adjudicator decision that affirms the
IRE’s adverse coverage determination.
We also are proposing to remove
‘‘hearing’’ before ‘‘decision’’ in
paragraph (b)(4)(v) to reflect that an
attorney adjudicator issues decisions
without conducting a hearing, and an
ALJ may issue a decision without
conducting a hearing.
In paragraph (b)(4)(vi), we are
proposing to remove ‘‘ALJ’s’’ and insert
‘‘ALJ’s or attorney adjudicator’s’’ in its
place to implement the proposal to
allow attorneys to adjudicate requests
for an ALJ hearing when no hearing is
conducted as proposed in section II.B
above, by including an attorney
adjudicator’s decision as a decision that
may be affirmed by the Council. We also
are proposing to remove ‘‘hearing’’
before ‘‘decision’’ in paragraph (b)(4)(vi)
because while the Council may conduct
a hearing, Council decisions are
generally issued without conducting a
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hearing, and the decision of the Council
is subject to judicial review.
We are inviting public comments on
these proposals. If you choose to
comment on the proposals in this
section, please include the caption ‘‘Part
423, subpart M general provisions’’ at
the beginning of your comment.
b. Part 423, Subpart U Title and Scope
(§ 423.1968)
The current heading of part 423,
subpart U references ALJ hearings but
does not reference decisions. We are
proposing to revise the heading by
replacing ‘‘ALJ Hearings’’ with ‘‘ALJ
hearings and ALJ and attorney
adjudicator decisions’’ to reflect that
subpart U covers decisions by ALJs and
attorney adjudicators, as proposed in
section II.B above.
Current § 423.1968 explains the scope
of the requirements in subpart U. We are
proposing at § 423.1968 to expand the
scope of subpart U to include actions by
attorney adjudicators, as proposed in
section II.B above. Specifically, we are
proposing at § 423.1968(a) to add that
subpart U sets forth requirements
relating to attorney adjudicators with
respect to reopenings; at § 423.1968(b)
to add that subpart U sets forth
requirements relating to ALJ decisions
and decisions of attorney adjudicators if
no hearing is conducted; and at
§ 423.1968(d) to add that subpart U sets
forth the requirements relating to Part D
enrollees’ rights with respect to ALJ
hearings and ALJ or attorney adjudicator
reviews. These changes would be
necessary to accurately describe the
scope of the revised provisions of
subpart U to implement the attorney
adjudicator proposal discussed in
section II.B above.
We are inviting public comments on
these proposals. If you choose to
comment on the proposals in this
section, please include the caption ‘‘Part
423, subpart U title and scope’’ at the
beginning of your comment.
c. Medicare Initial Determinations,
Redeterminations and Appeals General
Description (§ 405.904)
Section 405.904(a) provides a general
overview of the entitlement and claim
appeals process to which part 405,
subpart I applies. Current paragraphs
(a)(1) and (a)(2) provide that if a
beneficiary obtains a hearing before an
ALJ and is dissatisfied with the decision
of the ALJ, the beneficiary may request
that the Council review the case. To
provide for the possibility that a
decision may be issued without
conducting a hearing by an ALJ, as
permitted under current rules, or an
attorney adjudicator, as proposed in II.B
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above, we are proposing to add language
in paragraphs (a)(1) and (a)(2) to provide
that if the beneficiary is dissatisfied
with the decision of an ALJ or attorney
adjudicator when no hearing is
conducted, the beneficiary may request
that the Council review the case. This
proposal would provide a
comprehensive overview of the
entitlement and claim appeals process,
with information on the potential for
and right to appeal decisions by ALJs
when no hearing is conducted, and the
right to appeal decisions by attorney
adjudicators, if the attorney adjudicator
proposals are made final.
We are inviting public comments on
this proposal. If you choose to comment
on the proposal in this section, please
include the caption ‘‘Medicare initial
determinations, redeterminations and
appeals general description’’ at the
beginning of your comment.
d. Parties to the Initial Determinations,
Redeterminations, Reconsiderations,
Proceedings on a Request for Hearing,
and Council Review (§ 405.906)
Current § 405.906 discusses parties to
the appeals process and subsection (b)
currently addresses parties to the
redetermination, reconsideration,
hearing and MAC. We are proposing in
the paragraph heading and introductory
text to subsection (b) to replace the
phrases ‘‘hearing and MAC’’ and
‘‘hearing, and MAC review,’’
respectively, with ‘‘proceedings on a
request for hearing, and Council
review’’ because, absent an assignment
of appeal rights, the parties are parties
to all of the proceedings on a request for
hearing, including the hearing if one is
conducted, and they are parties to the
Council’s review.
We are inviting public comments on
this proposal. If you choose to comment
on the proposal in this section, please
include the caption ‘‘Parties to the
initial determinations, redeterminations,
reconsiderations, hearings, and
reviews’’ at the beginning of your
comment.
e. Medicaid State Agencies (§ 405.908)
Current § 405.908 discusses the role of
Medicaid State agencies in the appeals
process and states that if a State agency
files a request for redetermination, it
may retain party status at the QIC, ALJ,
MAC and judicial review levels. We are
proposing to replace ‘‘ALJ’’ with
‘‘OMHA’’ to provide that the State
agency has party status regardless of the
adjudicator assigned to the State
agency’s request for an ALJ hearing or
request for review of a QIC dismissal at
the OMHA level of review, as attorney
adjudicators may issue decisions on
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requests for hearing and adjudicate
requests for reviews of QIC dismissals,
as proposed in section II.B above.
We are inviting public comments on
this proposal. If you choose to comment
on the proposal in this section, please
include the caption ‘‘Medicaid State
agencies’’ at the beginning of your
comment.
f. Appointed Representatives (§ 405.910)
The 2002 Proposed Rule (67 FR 69318
through 69319) explained that the
§ 405.910 requirements for a valid
appointment of a representative are
necessary to help ensure that
adjudicators are sharing and
disseminating confidential information
with the appropriate individuals. The
2005 Interim Final Rule (70 FR 11428
through 11431) adopted a general
requirement to include a beneficiary’s
health insurance claim number (HICN)
for a valid appointment of a
representative in § 405.910(c)(5). The
SMART Act Final Rule (80 FR 10614,
10617) revised § 405.910(c)(5) to
explicitly limit the requirement to
include a beneficiary’s HICN to
instances in which the beneficiary is the
party appointing a representative.
However, the Medicare manual
provision for completing a valid
appointment of representative
(Medicare Claims Processing Manual
(Internet-Only Manual 100–4), chapter
29, § 270.1.2) details the requirements
for an appointment of representation to
contain a unique identifier of the party
being represented. Specifically, if the
party being represented is the
beneficiary, the Medicare number must
be provided, and if the party being
represented is a provider or supplier,
the National Provider Identifier (NPI)
number should be provided.
Additionally, the official form for
executing a valid appointment of
representative (form CMS–1696,
available at https://www.cms.gov/
Medicare/CMS-Forms/CMS-Forms/
Downloads/CMS1696.pdf) provides a
blank space for the party to include a
Medicare or NPI number. To assist
adjudicators in sharing and
disseminating confidential information
only with appropriate individuals, we
are proposing to revise § 405.910(c)(5) to
add a requirement to include the
Medicare NPI of the provider or
supplier that furnished the item or
service when the provider or supplier is
the party appointing a representative.
We are retaining the requirement to
identify the beneficiary’s Medicare
HICN when the beneficiary is the party
appointing a representative.
Current § 405.910 also addresses
defective appointments, and delegations
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and revocations of appointments.
However, there has been confusion on
the effects on the adjudication of an
appeal when a defective appointment
must be addressed, or when an
adjudicator is not timely informed of a
delegation or revocation of an
appointment. To address the effect of a
defective appointment on the
adjudication of an appeal to which an
adjudication time frame applies, we are
proposing to add § 405.910(d)(3), which
would extend an applicable
adjudication time frame from the later of
(1) the date that a defective appointment
of representative was filed or (2) the
date the current appeal request was filed
by the prospective appointed
representative, to the date that the
defect in the appointment was cured or
the party notifies the adjudicator that he
or she will proceed with the appeal
without a representative. We are
proposing this revision because, in
accordance with current § 405.910(d)(1)
and (d)(2), a prospective appointed
representative lacks the authority to act
on behalf of a party and is not entitled
to obtain or receive any information
related to the appeal. Thus, contact with
the party may be necessary to obtain
missing information from the
appointment, which may delay
adjudicating the appeal until the
appointment is cured or the party
decides to proceed with the appeal
without a representative. However, we
are proposing that if the request was
filed by a prospective appointed
representative, the request would be
considered filed for the purpose of
determining timeliness of the request,
even if the individual is not the
appointed representative after the
appointment is cured, or the party
decides to proceed with the appeal
without a representative.
We are also proposing at
§ 405.910(f)(1) to replace ‘‘ALJ level’’
with ‘‘OMHA level’’ so there is no
confusion that proceedings at the
OMHA level are considered proceedings
before the Secretary for purposes of
appointed representative fees, regardless
of whether the case is assigned to an
ALJ or attorney adjudicator.
Current § 405.910(i)(2) and (i)(3)
provide that if an appeal involves an
appointed representative, an ALJ sends
notices of actions or appeal decisions,
and requests for information or evidence
regarding a claim that is appealed to the
appointed representative. We are
proposing to insert ‘‘or attorney
adjudicator’’ after ‘‘ALJ’’ in
§ 405.910(i)(2) and (i)(3). This proposal
would provide that attorney
adjudicators (as proposed in section II.B
above), like an ALJ under the current
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provisions, would send notices of
actions or appeal decisions, and
requests for information or evidence
regarding a claim that is appealed to the
appointed representative.
A representative and/or the
represented party is responsible for
keeping the adjudicator of a pending
appeal current on the status of the
representative. In practice, sometimes
adjudicators are not informed of a
delegation or revocation of an
appointment of representative that has
been filed for an appeal, which results
in confusion and potentially duplicative
or unnecessary proceedings. We are
proposing to revise § 405.910(l)(2)
(which, as described later, we are
proposing to re-designate as (l)(1)(ii)) to
add that a delegation is not effective
until the adjudicator receives a copy of
the party’s written acceptance of the
delegation, unless the representative
and designee are attorneys in the same
law firm or organization, in which case
the written notice to the party of the
delegation may be submitted if the
acceptance is not obtained from the
party. This proposed revision would
emphasize the importance of keeping
adjudicators current on the status of the
representative and also state the effects
of failing to do so. Proposed
§ 405.910(l)(2) also serves to assist
adjudicators in sharing and
disseminating confidential information
only with appropriate individuals, and
to provide adjudicators with appropriate
contact information for scheduling
purposes. To accommodate proposed
paragraph (l)(2), current paragraph (l),
except for the title of the paragraph,
would be re-designated as paragraph
(l)(1), and the current subparagraphs
would also be re-designated
accordingly. In addition, we are
proposing to add a missing ‘‘by’’ in
current paragraph (l)(1)(ii) (redesignated as (l)(1)(i)) of § 405.910 to
indicate that a designee accepts to be
obligated ‘‘by’’ and comply with the
requirements of representation. We are
also proposing to revise language in
current paragraph (l)(2) (re-designated
as (1)(l)(ii)) of § 405.910 to clarify that
‘‘this signed statement’’ refers to the
‘‘written statement signed by the party,’’
and the written statement signed by the
party is not required when the
appointed representative and designee
are attorneys in the same law firm or
organization and the notice of intent to
delegate under paragraph (l)(1)(i)
indicates that fact. To further emphasize
the importance of keeping adjudicators
current on the status of the
representative and clarify the effects of
failing to do so, we are also proposing
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to add § 405.910(l)(3) and (m)(4) that a
party’s or representative’s failure to
notify the adjudicator that an
appointment of representative has been
delegated or revoked, respectively, is
not good cause for missing a deadline or
not appearing at a hearing.
We are not proposing any changes for
part 423, subpart U because it does not
have a corresponding provision for
representative appointments.
We are inviting public comments on
these proposals. If you choose to
comment on the proposals in this
section, please include the caption
‘‘Appointed representatives’’ at the
beginning of your comment.
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g. Actions That Are Not Initial
Determinations (§ 405.926)
Current § 405.926(l) provides that an
ALJ’s decision to reopen or not to
reopen a decision is not an initial
determination, and in accordance with
the introductory language of § 405.926,
is therefore not appealable under
subpart I. In section III.A.2.l below, we
are proposing to revise the reopening
rules to provide that attorney
adjudicators would have the authority
to reopen their decisions to the same
extent that ALJs may reopen their
decisions under the current provisions.
We are proposing to insert ‘‘or attorney
adjudicator’s’’ after ‘‘ALJ’s’’ in
§ 405.926(l) to provide that the attorney
adjudicator’s decision to reopen a
decision also is an action that is not an
initial determination and therefore not
an appealable action under subpart I.
Current § 405.926(m) provides that a
determination that CMS or its
contractors may participate in or act as
parties in an ALJ hearing is not an
initial determination, and in accordance
with the introductory language of
§ 405.926, is therefore not appealable
under subpart I. As explained in section
III.A.3.f below, we are proposing to
revise § 405.1010, which currently
discusses when CMS or a contractor
may participate in an ALJ hearing. As
explained in the proposal to revise
§ 405.1010, CMS or a contractor may
elect to participate in the proceedings
on a request for an ALJ hearing for
which no hearing is conducted, in
addition to participating in an ALJ
hearing as a non-party participant. To
align with our proposed revision to
§ 405.1010, we are proposing to revise
§ 405.926(m) to indicate that CMS or its
contractors may participate in the full
scope of the proceedings on a request
for an ALJ hearing, including the
hearing, by replacing ‘‘participate in or
act as parties in an ALJ hearing,’’ with
‘‘participate in the proceedings on a
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request for an ALJ hearing or act as
parties in an ALJ hearing.’’
We are inviting public comments on
these proposals. If you choose to
comment on the proposals in this
section, please include the caption
‘‘Actions that are not initial
determinations’’ at the beginning of
your comment.
h. Notice of a Redetermination
(§ 405.956)
Current § 405.956(b)(8) requires that
the notice of a redetermination include
a statement that evidence not submitted
to the QIC is not considered at an ALJ
hearing or further appeal, unless the
appellant demonstrates good cause as to
why that evidence was not provided
previously. We are proposing to remove
‘‘an ALJ hearing’’ and add ‘‘the OMHA
level’’ in its place so that the notice of
a redetermination is clear that, absent
good cause and subject to the exception
in § 405.956(d) for beneficiaries not
represented by a provider or supplier,
evidence that was not submitted to the
QIC is not considered by an ALJ or an
attorney adjudicator, as defined in
Section II.B above.
We are inviting public comments on
this proposal. If you choose to comment
on the proposal in this section, please
include the caption ‘‘Notice of a
redetermination’’ at the beginning of
your comment.
i. Time Frame for Making a
Reconsideration Following a Contractor
Redetermination, Withdrawal or
Dismissal of a Request for
Reconsideration, and Reconsideration
(§§ 405.970, 405.972, and 405.974)
As discussed in the 2005 Interim
Final Rule (70 FR 11444 through 11445)
and the 2009 Final Rule (74 FR 65311
through 65312), HHS adopted a policy
of providing for one level of
administrative review of a dismissal of
a request for appeal. As a result, an
adjudicator’s decision or dismissal
when reviewing a dismissal action
issued at the previous level is binding
and not subject to further review. The
policy balances a party’s need for
review and the need for administrative
finality. The policy is embodied in the
rules relating to reviews of dismissals at
the next adjudicative level in current
§§ 405.972(e), 405.974(b)(3),
405.1004(c), 405.1102(c), 405.1108(b),
and 405.1116.
At the QIC level of appeal, a review
of a contractor redetermination and a
review of a contractor’s dismissal of a
request for a redetermination are both
characterized as a ‘‘reconsideration.’’
While the outcome of a QIC’s
reconsideration of a contractor dismissal
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is differentiated and further reviews are
not permitted in accordance with
current § 405.974(b)(3), an ambiguity
exists with regard to the time frame for
completing this type of reconsideration
and escalation options when that time
frame is not met. Current § 405.970
establishes the time frame for making a
reconsideration without further
qualification. However, section
1869(b)(1)(D)(i) of the Act establishes
that a right to a reconsideration of an
initial determination (which includes a
redetermination under section
1869(a)(3)(D) of the Act) exists if a
timely request for a reconsideration is
filed within 180 days following receipt
of a contractor’s redetermination, which
is discussed in current § 405.962. In
contrast, current § 405.974(b)(1) requires
that a request for a QIC reconsideration
of a contractor’s dismissal of a request
for redetermination must be filed within
60 calendar days after receiving the
contractor’s notice of dismissal. Section
1869 of the Act does not address
dismissals. Rather, section
1869(c)(3)(C)(i) and (c)(3)(C)(ii) of the
Act only provide for a time frame to
complete a reconsideration of an initial
determination, and an option to escalate
a case if that time frame is not met.
The effect of the ambiguity in current
§ 405.970 is the potential escalation of a
request for a QIC reconsideration of a
contractor’s dismissal when the
reconsideration is not completed within
60 calendar days of a timely filed
request for a reconsideration of the
dismissal, and a potential hearing being
required in accordance with current
§ 405.1002(b). The potential effect of
this ambiguity is contrary to the policy
of limiting reviews of dismissals to the
next adjudicative level of administrative
appeal, as well as the statutory construct
for providing ALJ hearings after QIC
reconsiderations of redeterminations, or
escalations of requests for
reconsiderations following a
redetermination. We also note that in
the parallel context of an ALJ review of
a QIC’s dismissal of a request for
reconsideration, current §§ 405.1002
and 405.1004 establish a clear
distinction between a request for
hearing following a QIC reconsideration
and a request for a review of a QIC
dismissal, and current §§ 405.1016 and
405.1104 address the adjudication time
frames for ALJ decisions, and the option
to escalate an appeal to the Council
when a time frame is not met, only in
the context of a request for hearing, in
accordance with section 1869(d)(1) and
(d)(3)(A) of the Act.
To address this unintended outcome
of current § 405.970, we are proposing
to amend the title of § 405.970 and
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paragraphs (a), (b)(1), (b)(2), (b)(3), (c),
(e)(1), and (e)(2)(i) to provide that the
provisions would only apply to a
request for a reconsideration following a
contractor redetermination, and not to a
request for QIC review of a contractor’s
dismissal of a request for
redetermination. These proposed
revisions would further our policy on
reviews of dismissals and help
appellants better understand what may
be escalated to OMHA for an ALJ
hearing. We are also proposing to
replace ‘‘the ALJ hearing office’’ in
current paragraph (e)(2)(ii) with
‘‘OMHA’’ because the QIC sends case
files for escalated cases to a centralized
location, not to individual field offices.
We did not propose any parallel
changes for part 423 because subpart U
does not address IRE reconsiderations
and subpart M does not have a
provision with the same ambiguity.
To provide additional clarity to the
procedures for reviews of dismissal
actions we are also proposing to amend
the text in §§ 405.972(b)(3), (e) and
405.974(b)(3), and the introductory text
of § 405.974(b) to replace the references
to a ‘‘reconsideration’’ of a contractor’s
dismissal of a request for
redetermination with the word ‘‘review’’
so that the QIC’s action is referred to as
a review of a contractor’s dismissal of a
request for redetermination. We are also
proposing to revise the section heading
of § 405.972 to read ‘‘Withdrawal or
dismissal of a request for
reconsideration or review of a
contractor’s dismissal of a request for
redetermination’’ and the section
heading of § 405.974 to read,
‘‘Reconsideration and review of a
contractor’s dismissal of a request for
redetermination.’’ These proposed
revisions are consistent with the
description of a reconsideration in
section 1869(c)(3)(B)(i) of the Act and
§ 405.968(a). A QIC’s review of a
contractor dismissal action is limited to
the appropriateness of the dismissal
action and does not consist of a review
of the initial determination and
redetermination, which is the meaning
attributed to a reconsideration. In
reviewing a contractor dismissal action,
the QIC either affirms or vacates the
dismissal of the request for
redetermination. If a dismissal action is
vacated, the appeal is remanded back to
the MAC to conduct a redetermination
on the merits (§ 405.974).
Current § 405.972(e) provides that a
QIC’s dismissal of a request for
reconsideration is binding unless it is
modified or reversed by an ALJ under
§ 405.1004. As discussed in section II.B
above, we are proposing that an attorney
adjudicator may conduct a review of a
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QIC’s dismissal of a request for
reconsideration and in section III.A.3.c
below, we are proposing to revise
§ 405.1004 to provide the effect of an
attorney adjudicator’s action taken in
reviewing the QIC dismissal is
equivalent to the effect of an ALJ’s
action taken in reviewing the QIC
dismissal. To align with our proposed
revision to § 405.1004, we are proposing
to insert ‘‘or attorney adjudicator’’ after
‘‘an ALJ’’ in § 405.972(e) to indicate that
a QIC’s dismissal of a request for
reconsideration is binding unless it is
modified or reversed by an ALJ or
attorney adjudicator under § 405.1004.
We are inviting public comments on
these proposals. If you choose to
comment on the proposals in this
section, please include the caption
‘‘Time frame for making a
reconsideration following a contractor
redetermination, withdrawal or
dismissal of a request for
reconsideration, and reconsideration’’ at
the beginning of your comment.
j. Notice of Reconsideration (§ 405.976)
Section 1869(b)(3) of the Act states
that a provider or supplier may not
introduce evidence in any appeal that
was not presented at the reconsideration
conducted by a QIC unless there is good
cause as to why the evidence was not
provided prior to the issuance of the
QIC’s reconsideration. Under this
authority, current § 405.976(b)(5)(ii)
provides that a notice of reconsideration
must include a summary of the rationale
for the reconsideration that specifies
that all evidence that is not submitted
prior to the issuance of the
reconsideration will not be considered
at the ALJ level, or made part of the
administrative record, unless the
appellant demonstrates good cause as to
why the evidence was not provided
prior to the issuance of the QIC’s
reconsideration; however, it does not
apply to a beneficiary unless the
beneficiary is represented by a provider
or supplier or to state Medicaid
agencies. The statement that the
evidence will not be made part of the
administrative record is inconsistent
with our practice of making a complete
record of the administrative proceedings
for further reviews, including
documents submitted by parties that
were not considered in making the
decision. Current § 405.1028(c) states
that if good cause does not exist, the ALJ
must exclude the evidence from the
proceedings and may not consider it in
reaching a decision. However, it does
not instruct the ALJ to remove the
evidence from the administrative
record, and to do so would preclude an
effective review of the good cause
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determination. In addition, we noted in
the 2005 Interim Final Rule (70 FR
11464) that under current
§ 405.1042(a)(2), excluded evidence is
part of the record because it states that
in the record, the ALJ must also discuss
any evidence excluded under
§ 405.1028 and include a justification
for excluding the evidence. To help
ensure that the evidence is preserved in
the administrative record, we are
proposing to delete ‘‘or made part of the
administrative record’’ from the
paragraph in § 405.976(b)(5)(ii).
Current § 405.976(b)(7) requires that
the QIC notice of reconsideration
contain a statement of whether the
amount in controversy needed for an
ALJ hearing is met when the
reconsideration is partially or fully
unfavorable. As further discussed in
section III.A.3.d below, we are
proposing revisions to § 405.976(b)(7)
along with revisions to the methodology
for calculating the amount in
controversy required for an ALJ hearing
under § 405.1006(d) to better align the
amount in controversy with the actual
amount in dispute. Please refer to
section III.A.3.d for a discussion of these
proposals.
We are not proposing any changes to
part 423 because subpart U does not
address IRE reconsiderations and
subpart M does not contain similar
provisions.
We are inviting public comments on
this proposal. If you choose to comment
on the proposal in this section, please
include the caption ‘‘Notice of
reconsideration’’ at the beginning of
your comment.
k. Effect of a Reconsideration (§ 405.978)
Current § 405.978 discusses the effect
of a QIC reconsideration, and states that
a reconsideration is binding on all
parties unless, among other things, an
ALJ decision is issued in accordance to
a request for an ALJ hearing made in
accordance with § 405.1014. As
discussed in section II.B above, we are
proposing that an attorney adjudicator
may issue a decision on a request for an
ALJ hearing when a hearing is not
conducted, and in section III.A.3.v
below, we are proposing to revise
§ 405.1048 to provide the effect of an
attorney adjudicator’s decision is
equivalent to the effect of an ALJ’s
decision. To align with our proposals to
provide that an attorney adjudicator
may issue a decision on a request for an
ALJ hearing when a hearing is not
conducted and the effect of that
decision is equivalent to the effect of an
ALJ’s decision, we are proposing to
insert ‘‘or attorney adjudicator’’ after the
first use of ‘‘ALJ’’ in § 405.978(a) to
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indicate that a QIC reconsideration is
binding on all parties unless, among
other things, an ALJ or attorney
adjudicator decision is issued in
accordance to a request for an ALJ
hearing made in accordance with
§ 405.1014.
We are inviting public comments on
this proposal. If you choose to comment
on the proposal in this section, please
include the caption ‘‘Effect of a
reconsideration’’ at the beginning of
your comment.
l. Reopenings (§§ 405.980, 405.982,
405.984, 423.1978, 423.1980, 423.1982,
and 423.1984)
Sections 405.980 and 423.1980 set
forth the rules governing reopening and
revision of initial determinations,
redeterminations, reconsiderations,
decisions, and reviews; §§ 405.982 and
423.1982 set forth the rules governing
notice of a revised determination or
decision; and §§ 405.984 and 423.1984
set forth the rules on the effect of a
revised determination or decision.
Pursuant to current §§ 405.1038 and
423.2038, an ALJ may issue a decision
on a request for hearing without
conducting a hearing in specified
circumstances. As proposed in section
II.B above, an attorney adjudicator also
would be able to issue decisions on
requests for an ALJ hearing in specified
circumstances, issue dismissals when a
party withdraws a request for hearing,
and issue decisions on requests to
review QIC or IRE dismissals.
We are proposing to insert ‘‘or
attorney adjudicator’’ or ‘‘attorney
adjudicator’s,’’ after ‘‘ALJ’’ or ‘‘ALJ’s’’ in
§§ 405.980(a)(1)(iii), (a)(4), (a)(5), (d)
introductory text, (d)(2), (e)(2);
405.982(a), (b); 405.984(d);
423.1980(a)(1)(iii), (a)(4), (d)
introductory text, (d)(2), (e)(2);
423.1982(a), (a)(1), (a)(2), (b), (b)(1), and
(b)(2); 423.1984(d); 423.1978(a);
423.1980(a)(2). These proposals would
provide that decisions issued by
attorney adjudicators, as proposed in
section II.B above, may be reopened in
the same manner as decisions issued by
an ALJ (that is, when there is good cause
in accordance with §§ 405.986 or
423.1986, or the decision was procured
by fraud or similar fault), and with the
same limitations, requirements, and
effects as reopening an ALJ decision. We
believe it is necessary for an attorney
adjudicator or the Council to have the
authority to reopen the attorney
adjudicator’s decision on the same bases
as an ALJ or the Council may reopen the
ALJ’s decision under the current rules;
to address instances in which there is
good cause to reopen the attorney
adjudicator’s decision (in accordance
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with §§ 405.986 or 423.1986) or the
attorney adjudicator’s decision was
procured by fraud or similar fault; and
the action should be subject to the same
limitations and requirements, and have
the same effects as an ALJ’s action
under the provisions.
We are also proposing to replace
‘‘hearing decision,’’ ‘‘hearing
decisions,’’ or ‘‘hearings,’’ with
‘‘decision’’ or ‘‘decisions’’ in the titles of
current §§ 405.980 and 423.1980;
§§ 405.980(a)(1)(iii), (d) introductory
text, (d)(2), (e) introductory text, and
(e)(2); 423.1980(a)(1)(iii), (d)
introductory text, (d)(2), (e) introductory
text, and (e)(2); to replace ‘‘hearing’’
with ‘‘ALJ or attorney adjudicator
decision’’ in §§ 405.980(a)(1)(iv), (a)(4),
(e)(2); 423.1980(a)(1)(iv), (a)(2), and
(e)(2); and to replace ‘‘ALJ hearing
decisions’’ and ‘‘hearing decision,’’ with
‘‘ALJ or attorney adjudicator decisions’’
and ‘‘ALJ or attorney adjudicator
decision’’, respectively, in §§ 405.984(d)
and 423.1984(d). These proposals would
avoid any confusion that reopening
under these provisions is limited to
decisions for which an oral hearing was
conducted, whether the decision is
issued by an ALJ without conducting a
hearing, as permitted under current
rules or by an attorney adjudicator
without conducting a hearing, as
proposed in section II.B above.
In addition, we are proposing to add
in §§ 405.980(a)(1)(iii), (d)(2), (e)(2), and
423.1980(a)(1)(iii), (d)(2), (e)(2) that an
ALJ, or attorney adjudicator as proposed
in section II.B above, revises ‘‘his or
her’’ decision and may reopen ‘‘his or
her’’ decision, which reflects our
current policy that the deciding ALJ
may reopen his or her decision, and
avoids any potential confusion that an
ALJ or attorney adjudicator may reopen
the decision of another ALJ or attorney
adjudicator. We are also proposing to
insert ‘‘its’’ before ‘‘review’’ in
§§ 405.980(a)(1)(iv) and
423.1980(a)(1)(iv) to indicate that the
Council’s review decision may only be
reopened by the Council, to differentiate
it from an ALJ or attorney adjudicator
decision that the Council may also
reopen. In addition, we are proposing to
specify in §§ 405.980(d)(2) and (e)(2),
and 423.1980(d)(2) and (e)(2) that the
Council may reopen ‘‘an ALJ or attorney
adjudicator’’ decision consistent with
the current policy that the Council may
reopen an ALJ decision, and to
differentiate the provisions from
§§ 405.980(d)(3) and (e)(3), and
423.1980(d)(3) and (e)(3), which provide
for the Council to reopen its review
decision. We also propose in
§ 405.980(e)(3) to insert ‘‘Council’’
before ‘‘review’’ to clarify that a party to
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a Council review may request that the
Council reopen its decision.
Finally, we are proposing at
§ 405.984(c) to replace ‘‘in accordance
with § 405.1000 through § 405.1064’’
with ‘‘in accordance with § 405.1000
through § 405.1063’’ to account for the
proposed removal of § 405.1064
discussed below.
We are inviting public comments on
these proposals. If you choose to
comment on the proposals in this
section, please include the caption
‘‘Reopenings’’ at the beginning of your
comment.
m. Expedited Access to Judicial Review
(§§ 405.990 and 423.1990)
Sections 405.990 and 423.1990 set
forth the procedures governing
expedited access to judicial review
(EAJR). Current §§ 405.990(d) and
423.1990(d) allow a requesting party to
file an EAJR request with an ALJ or the
Council, which is then responsible for
forwarding the request to the EAJR
review entity within 5 calendar days of
receipt. In accordance with current
§§ 405.990(f) and 423.1990(e), a request
for EAJR must be acted upon by the
EAJR review entity within 60 calendar
days after the date that the review entity
receives a request and accompanying
documents and materials. In practice,
this process has resulted in confusion
and delays for requesting parties when
EAJR requests are sent directly to an ALJ
or the Council. To simplify the process
for requesting parties and to help ensure
the timely processing of EAJR requests,
we are proposing to revise
§§ 405.990(d)(1) and 423.1990(d)(1) to
direct EAJR requests to the DAB, which
administers the EAJR process.
Specifically, we are proposing at
§§ 405.990(d)(1)(i) and (ii), and
423.1990(d)(1)(i) and (ii) that the
requestor or enrollee may file a written
EAJR request with the DAB with the
request for ALJ hearing or Council
review if a request for ALJ hearing or
Council review is not pending, or file a
written EAJR request with the DAB if an
appeal is already pending for an ALJ
hearing or otherwise before OMHA or
the Council. We are also proposing to
revise §§ 405.990(i)(1) and (2) and
423.1990(h)(1) and (2) so that the review
entity would forward a rejected EAJR
request to OMHA or the Council instead
of an ALJ hearing office or the Council,
to align with the revised EAJR filing
process in which a request for ALJ
hearing is submitted to the DAB with an
EAJR request; this would also help
ensure OMHA can process the request
for an ALJ hearing as quickly as possible
in the event an EAJR request is rejected.
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Current §§ 405.990(i)(2) and
423.1990(h)(2) provide that a 90
calendar day time frame will apply to an
appeal when a rejected EAJR request is
received by the hearing office or the
Council. Current § 405.990(b)(1)(ii)
states that an EAJR request may be filed
when a request for a QIC
reconsideration has been escalated for
an ALJ hearing, and in accordance with
current § 405.1016(c), a 180 calendar
day time frame will apply in that
circumstance. In addition, current
§§ 405.1036(d) and 423.2036(d) allow an
appellant or enrollee to waive the
adjudication period for an ALJ to issue
a decision specified in §§ 405.1016 and
405.2016, respectively, at any time
during the hearing process. To address
the possibility that a time frame other
than 90 calendar days applies to an
appeal, or no adjudication time frame
applies to an appeal, we are proposing
to revise §§ 405.990(i)(2) and
423.1990(h)(2) to remove the reference
to 90 calendar days and provide that if
an adjudication time frame applies to an
appeal, the adjudication time frame
begins on the day the request for hearing
is received by OMHA or the request for
review is received by the Council, from
the EAJR review entity.
In addition, proposed § 405.990(i)(1)
would remove the redundant ‘‘request’’
after ‘‘EAJR request’’ in current
paragraph (i)(1), which was a drafting
error; and proposed § 423.1990(b)(1)(i)
would remove ‘‘final’’ before referring to
a decision, dismissal, or remand order
of the ALJ or attorney adjudicator, as
proposed in section II.B above, because
as we explained in the 2009 Final Rule
(74 FR 65307 through 65308), final
decisions of the Secretary are those for
which judicial review may be
immediately sought under section
205(g) of the Act and the use of ‘‘final’’
in current § 423.1990(b)(1)(i) may cause
confusion with such a final decision.
We are inviting public comments on
these proposals. If you choose to
comment on the proposals in this
section, please include the caption
‘‘Expedited access to judicial review’’ at
the beginning of your comment.
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3. ALJ Hearings
a. Hearing Before an ALJ and Decision
by an ALJ or Attorney Adjudicator:
General Rule (§§ 405.1000 and
423.2000)
Current §§ 405.1000 and 423.2000
provide a general overview and rules for
hearings before an ALJ and decisions on
requests for hearings. We are proposing
to revise §§ 405.1000(d), (e), (g); and
423.2000(d), (e), (g) to include decisions
by attorney adjudicators, as proposed in
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section II.B above. We are also
proposing to retitle the sections to
reflect that the provisions of the section
extend to decisions by both ALJ and
attorney adjudicators. We are proposing
to change the language in
§§ 405.1000(a), (b), (c), and (d); and
423.2000(a) and (b) to state that a
hearing may only be conducted by an
ALJ. These proposals would provide
readers with an accurate overview of
how a request for an ALJ hearing would
be adjudicated, including the potential
that a decision could be issued without
conducting a hearing by an ALJ or an
attorney adjudicator as proposed in
section II.B above, while informing
readers that if a hearing is conducted, an
ALJ will conduct the hearing.
Current § 405.1000(c) provides that
CMS or a contractor may elect to
participate in a hearing, and
§ 423.2000(c) provides that CMS, the
IRE or Part D plan sponsor may request
to participate in a hearing. As discussed
in section III.A.3.f below, we are
proposing to revise §§ 405.1010 and
423.2010 so that these entities may elect
(for § 405.1010) or request (for
§ 423.2010) to participate in the
proceedings on a request for hearing,
including participation before a hearing
is scheduled. We are proposing to revise
§§ 405.1000(c) and 423.2000(c) so that
the sections would reference
§§ 405.1010 and 423.2010, respectively,
with regard to participating in the
proceedings. By referencing §§ 405.1010
and 423.2010, the proposed revisions
would direct readers to those sections
addressing the full scope of potential
participation by CMS or its contractors,
or a Part D plan sponsor, on a request
for an ALJ hearing, including
participating in the proceedings on a
request for an ALJ hearing, which as
discussed in proposed §§ 405.1010 and
423.2010, may include any proceedings
before an oral hearing is scheduled. We
are also proposing in § 405.1000(c) to
state that CMS or its contractor may join
the hearing before an ALJ as a party
under § 405.1012, which would direct
readers to the appropriate section
addressing the full scope of CMS or its
contractor acting as a party. (Because
CMS, the IRE, and the Part D plan
sponsor may not be a party to a hearing
under part 423, subpart U, there is no
corollary to § 405.1012 in that subpart
and therefore a similar revision is not
proposed for § 423.2000(c).)
Current §§ 405.1000(d) and
423.2000(d) provide that a decision is
based on the hearing record, and current
§§ 405.1000(g) and 423.2000(g)
reference a hearing record in describing
when a decision can be issued based on
the record, without a hearing. However,
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current §§ 405.1042 and 423.2042
identify the record as the administrative
record. The references to a hearing
record in current paragraphs (d) and (g)
may cause confusion when no hearing
is conducted. To make the terminology
consistent throughout the rules, account
for decisions that are issued without a
hearing being conducted, and minimize
confusion, we are proposing to revise
§§ 405.1000(d) and 423.2000(d) so that a
decision is based on the administrative
record, including, for an ALJ, any
hearing record, and §§ 405.1000(g) and
423.2000(g) to provide that a decision is
based on the administrative record.
Current § 405.1000(e) and (g) discuss
two circumstances in which a decision
on a request for hearing can be issued
by an ALJ without conducting a hearing,
either where the parties waive the
hearing or where the record supports a
fully favorable finding. Related to
current § 405.1000(e), current
§ 405.1000(f) discusses the ALJ’s
authority to conduct a hearing even if
the parties waive the hearing. As
discussed in section III.A.3.r below, we
are proposing to revise § 405.1038 to
modify the circumstances in which a
decision on a request for hearing can be
issued without conducting a hearing. As
discussed in the proposed revisions to
§ 405.1038, we would require that
waivers be obtained by the parties
entitled to a notice of hearing in
accordance with § 405.1020(c), or to
require that the record supports a fully
favorable finding for the appellant and
there is no other party or no other party
is entitled to a notice of hearing in
accordance with § 405.1020(c).
Proposed § 405.1000(e), (f), and (g)
would be revised for consistency with
the § 405.1038 proposals and to
accurately summarize when a decision
on a request for hearing can be issued
without conducting a hearing in
accordance with proposed § 405.1038.
We are not proposing similar changes in
§ 423.2000(e), (f), and (g) because we are
not proposing changes to when a
decision on a request for hearing can be
issued without conducting a hearing in
§ 423.2038.
Current § 405.964(c) requires a QIC to
consolidate requests for a
reconsideration filed by different parties
on the same claim before a
reconsideration is made on the first
timely filed request. While current
§ 405.1044 permits an ALJ to
consolidate requests for hearing if one
or more of the issues to be considered
at the hearing are the same issues that
are involved in another request for
hearing pending before the same ALJ,
the provision is discretionary and
dependent on the requests being
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assigned to the same ALJ. To mitigate
the potential of requests for hearing on
the same claim filed by different parties
being separately adjudicated, we are
proposing to add § 405.1000(h) to
require that when more than one party
files a timely request for hearing on the
same claim before a decision is made on
the first timely filed request, the
requests are consolidated into one
proceeding and record, and one
decision, dismissal, or remand is issued.
We note that if a decision was issued on
the first timely request before an
additional request is timely filed or
good cause is found to extend the period
to file the additional request for hearing,
a reopening of the decision may be
considered by the deciding adjudicator
in accordance with § 405.980. For
example, if a request is submitted with
new and material evidence that was not
available at the time of the decision and
may result in a different conclusion, the
reopening provisions at § 405.980 would
apply. Because only the enrollee is a
party in a part 423, subpart U
proceeding on a request for an ALJ
hearing, no corresponding changes are
proposed for § 423.2000.
We are inviting public comments on
these proposals. If you choose to
comment on the proposals in this
section, please include the caption
‘‘Hearing before an ALJ and decision by
an ALJ or attorney adjudicator general
rule’’ at the beginning of your comment.
b. Right to an ALJ Hearing (§§ 405.1002
and 423.2002)
Current §§ 405.1002 and 423.2002
discuss a right to an ALJ hearing.
Current §§ 405.1002(a) and 423.2002(a)
provide that a party to a QIC
reconsideration or the enrollee who
receives an IRE reconsideration,
respectively, may ‘‘request’’ a hearing
before an ALJ if the party or enrollee
files a timely request and meets the
amount in controversy requirement.
However, a party or enrollee is entitled
to a hearing only when those
requirements are met. See sections
1860D–4(h) and 1869(b)(1)(A) of the
Act. Therefore, we are proposing to
revise §§ 405.1002(a) and 423.2002(a)
introductory text to state that the party
to a QIC reconsideration or the enrollee
who receives an IRE reconsideration has
a right to a hearing rather than may
request a hearing. These proposed
changes would align the provisions with
the statute and clarify that the party or
enrollee has a right to a hearing before
an ALJ when the criteria are met.
Current §§ 405.1002(a)(4) and
423.2002(e) provide that the request is
considered filed on the date it is
received by the entity specified in the
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QIC’s or IRE’s reconsideration. There
has been confusion when a request is
sent to an OMHA office that is not
specified in the reconsideration, and
this error causes delays in processing
the request. We are proposing to revise
§§ 405.1002(a)(4) and 423.2002(e) to
replace ‘‘entity’’ with ‘‘office’’ to avoid
confusion that the request may be filed
with OMHA as an entity, and therefore
any OMHA office, rather than the
specific OMHA office identified in the
QIC’s or IRE’s reconsideration. This
would help ensure appellants are aware
that a request for hearing must be filed
with the office indicated in the notice of
reconsideration to avoid delays. For
example, when the notice of
reconsideration indicates that a request
for hearing must be filed with the
OMHA central docketing office, an
appellant will cause a delay if the
request is sent to the QIC or IRE, or an
OMHA field office. We also note that as
explained in the 2009 Final Rule (74 FR
65319 through 65320), pursuant to
current § 405.1014(b)(2), if a request for
hearing is timely filed with an entity
other than the entity specified in the
notice of reconsideration, the request is
not treated as untimely or otherwise
rejected. This would remain true for
requests that are timely filed with an
office other than the office specified in
the notice of reconsideration, pursuant
to proposed § 405.1014(c)(2), which
incorporates the requirement from
current § 405.1014(b)(2). This would
also apply in part 423, subpart U
adjudications because the same
language appears in current
§ 423.2014(c)(2) and is incorporated in
proposed § 423.2014(d)(2).
Current § 405.1002(b)(1) provides that
when a party files a request with the
QIC to escalate the appeal, it is escalated
to ‘‘the ALJ level.’’ We are proposing to
revise § 405.1002(b)(1) to replace ‘‘to the
ALJ level’’ with ‘‘for a hearing before an
ALJ’’ so that when a request for a QIC
reconsideration is escalated, it is
escalated ‘‘for a hearing before an ALJ.’’
This would help ensure that the right to
a hearing is clear when an appeal is
escalated from the QIC. There is no
corresponding provision in part 423,
subpart U.
Current § 423.2002(c) provides that
the ALJ must document all oral requests
for expedited hearings. However, an ALJ
is not assigned to an appeal until after
the request for hearing is received and
processed. Thus, we are proposing to
revise § 423.2002(c) to state that
‘‘OMHA’’ must document all oral
requests for expedited hearings. There is
no corresponding provision in part 405,
subpart I.
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We are inviting public comments on
these proposals. If you choose to
comment on the proposals in this
section, please include the caption
‘‘Right to an ALJ hearing’’ at the
beginning of your comment.
c. Right to a Review of QIC or IRE
Notice of Dismissal (§§ 405.1004 and
423.2004)
Current §§ 405.1004 and 423.2004
discuss the right to an ALJ review of a
QIC notice of dismissal or IRE notice of
dismissal, respectively. As proposed in
section II.B above, attorney adjudicators
or ALJs would conduct reviews of QIC
or IRE dismissals. Accordingly, we are
proposing to remove references to an
ALJ in the titles of proposed §§ 405.1004
and 423.2004, though ALJs would
continue to have the authority to
conduct reviews of QIC or IRE
dismissals if a request for a review of a
QIC or IRE dismissal is assigned to an
ALJ. We also propose to insert ‘‘or
attorney adjudicator’’ after ALJ in
§§ 405.1004(a) introductory language,
(b), (c); and 423.2004(a) introductory
language, (b), and (c), to provide that an
attorney adjudicator could review a QIC
or IRE dismissal, as proposed in section
II.B above. We also are proposing to
replace the reference to ‘‘entity’’ in
current §§ 405.1004(a)(4) and
423.2004(a)(4), with ‘‘office,’’ for the
same reasons discussed above in
III.A.3.b, for amending parallel language
in §§ 405.1002 and 423.2002.
Current §§ 405.1004(b) and
423.2004(b) provide that if an ALJ
determines that the QIC’s or IRE’s
dismissal was in error, he or she vacates
the dismissal and remands the case to
a QIC or IRE. As discussed in III.A.3.p
below, we are proposing to revise the
remand provisions and add new
§§ 405.1056 and 405.1058, 423.2056,
and 423.2058 to govern when remands
may be issued, whether and to what
extent remands may be reviewed,
providing notice of a remand, and the
effect of a remand. We are also
proposing to revise §§ 405.1004(b) and
423.2004(b) to add references to
proposed §§ 405.1056 and 423.2056,
respectively, to explain that the remand
would be in accordance with proposed
§§ 405.1056 and 423.2056, which as
discussed in section III.A.3.p below,
would address issuing remands and
notices thereof, including for remands
of QIC or IRE dismissals.
Current §§ 405.1004(c) and
423.2004(c) state that an ALJ’s decision
regarding a QIC’s or IRE’s dismissal of
a reconsideration request is binding and
not subject to further review, and that
the dismissal of a request for ALJ review
of a QIC’s or IRE’s dismissal of a
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reconsideration request is binding and
not subject to further review, unless
vacated by the Council under
§ 405.1108(h) or § 423.2108(b),
respectively. In our experience, these
sections as currently drafted have been
a source of confusion for adjudicators
and appellants. The two sentences
convey different actions that can result
from a request for review of a QIC or IRE
dismissal—a decision regarding whether
the QIC’s or IRE’s dismissal was correct,
or a dismissal of the appellant’s request
for an ALJ review of the QIC’s or IRE’s
dismissal. We are proposing to separate
and further distinguish the two
situations to avoid the current confusion
that results from two of the three
possible outcomes that may result from
a request to review a QIC or IRE
dismissal (the third being a remand of
the dismissal, addressed in paragraph
(b) in the respective sections) being in
the same paragraph by proposing a
separate paragraph for each outcome
currently addressed in paragraph (c).
We are proposing to revise
§§ 405.1004(c) and 423.2004(c) to
include the possible outcome in the first
sentence of current §§ 405.1004(c) and
423.2004(c) of a decision affirming the
QIC’s or IRE’s dismissal. We also are
proposing to move language in current
§§ 405.1004(c) and 423.2004(c) stating
that the decision of an ALJ on a request
for review of a QIC dismissal is binding
and not subject to further review, to
proposed §§ 405.1048(b) and
423.2048(b), which as discussed in
section III.A.3.v below, would address
the effects of decisions on requests to
review a QIC or IRE dismissal. In
addition, we are proposing in
§§ 405.1004(c) and 423.2004(c),
respectively, to state that a decision
affirming a QIC or IRE dismissal would
be issued in accordance with proposed
§§ 405.1046(b) and 423.2046(b), which
as discussed in section III.A.3.v below,
would address issuing decisions on
requests for review of a QIC or IRE
dismissal and notices thereof.
The 2009 Final Rule (74 FR 65311
through 65312) also explained that if a
request for ALJ review of a QIC
dismissal was invalid and thus subject
to dismissal, the dismissal of the request
to review a QIC dismissal was binding
and not subject to further review
(however, a party could request that the
dismissal be vacated by the Council
pursuant to § 405.1108(b)). We are
proposing to add §§ 405.1004(d) and
423.2004(d) to state that the ALJ or
attorney adjudicator may dismiss a
request for review of a QIC’s or an IRE’s
dismissal in accordance with proposed
§§ 405.1052(b) or 423.2052(b),
respectively, which as discussed in
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section III.A.3.x below, would address
dismissals of requests for review of a
QIC or IRE dismissal and notices
thereof. We also are proposing to move
language in current §§ 405.1004(c) and
423.2004(c) stating that the dismissal is
binding and not subject to further
review unless the dismissal is vacated,
to proposed §§ 405.1054(b) and
423.2054(b), which would address the
effects of a dismissal of a request for
review of a QIC’s or an IRE’s dismissal
and as discussed in section III.A.3.x
below, would provide authority for an
ALJ or attorney adjudicator to vacate a
dismissal and therefore replace the
current reference to the Council.
We are inviting public comments on
these proposals. If you choose to
comment on the proposals in this
section, please include the caption
‘‘Right to a review of QIC or IRE notice
of dismissal’’ at the beginning of your
comment.
d. Amount in Controversy Required for
an ALJ Hearing (§§ 405.1006,
405.976(b)(7), 423.1970, 422.600(b), and
478.44(a))
Current § 405.1006 sets forth the
requirements for meeting the amount in
controversy for an ALJ hearing. The title
of current § 405.1006 states that the
amount in controversy is required to
‘‘request’’ an ALJ hearing and judicial
review. However, as discussed in
III.A.3.b above, section 1869(b)(1)(A) of
the Act states that a party is entitled to
a hearing before the Secretary and
judicial review, subject to the amount in
controversy and other requirements. To
align the title of § 405.1006 with the
statutory provision, we are proposing
that the amount in controversy is
required ‘‘for’’ an ALJ hearing and
judicial review rather than ‘‘to request’’
an ALJ hearing and judicial review. Put
another way, a party may request an ALJ
hearing or judicial review, albeit
unsuccessfully, without satisfying the
amount in controversy requirement.
Section 1869(b)(1)(E) of the Act
establishes the minimum amounts in
controversy for a hearing by the
Secretary and for judicial review, but
does not establish how to calculate the
amounts in controversy. Current
§ 405.1006(d) states that the amount
remaining in controversy is calculated
based on the actual amount charged to
the individual (a beneficiary) for the
items or services in question (commonly
referred to as billed charges), reduced by
any Medicare payments already made or
awarded for the items or services, and
any deductible and coinsurance
amounts applicable to the particular
case. In an effort to align the amount in
controversy with a better approximation
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of the amount at issue in an appeal, we
are proposing to revise the basis (that is,
the starting point before any deductions
for any payments already made by
Medicare or any coinsurance or
deductible that may be collected) used
to calculate the amount in controversy.
For appeals of claims submitted by
providers of services, physicians, and
other suppliers that are priced based on
a published Medicare fee schedule or
published contractor priced amount (as
discussed below), rather than using the
actual amount charged to the individual
as the basis for the amount in
controversy, we are proposing to use the
Medicare allowable amount for the
items and/or services being appealed,
subject to the exceptions discussed
below. An allowable amount is the
maximum amount of the billed charge
deemed payable for the item or service.
For the purposes of the amount in
controversy under § 405.1006, we are
proposing at § 405.1006(d)(2)(i)(A) that
for items and services with a published
Medicare fee schedule or published
contractor-priced amount, the basis for
the amount in controversy is the
allowable amount, which would be the
amount reflected on the fee schedule or
in the contractor-priced amount for
those items or services in the applicable
jurisdiction and place of service.
For a vast majority of items and
services furnished and billed by
physicians and other suppliers,
allowable amounts are determined
based on Medicare fee schedules. Fee
schedules are updated and published on
an annual basis by CMS through
rulemaking, and CMS and its
contractors have tools and resources
available to inform physicians and other
suppliers of allowable amounts based
on these fee schedules, including the
Physician Fee Schedule Look-up Tool
available at https://www.cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/PFSlookup/ and spreadsheets
for other fee schedules that can be
accessed on the CMS Web site through
the fee schedule main page at https://
www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/
FeeScheduleGenInfo/.
Allowable amounts for many contractor
priced items and services are also
included in these tools and resources.
Allowable amounts are included on the
Medicare remittance advice for paid
items and services, but not for items and
services that are denied. However,
where the allowable amount for an item
or service is determined based on a
published fee schedule or contractor
priced amount, we anticipate that
appellants, other than beneficiaries who
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are not represented by a provider,
supplier, or Medicaid State agency,
would be able to use the existing CMS
and contractor tools and resources to
determine allowable amounts for denied
services when filing a request for
hearing, and those amounts could be
verified by OMHA in determining
whether the claims included in the
request meet the amount in controversy
requirement. As discussed below, where
the appellant is a beneficiary who is not
represented by a provider, supplier, or
Medicaid State agency, CMS would
require the QIC to specify in the notice
of reconsideration, for partially or fully
unfavorable reconsideration decisions,
whether the amount remaining in
controversy is estimated to meet or not
meet the amount required for an ALJ
hearing under proposed § 405.1006(d).
Due to the pricing methodology for
many items and services furnished by
providers of services, such as hospitals,
hospices, home health agencies, and
skilled nursing facilities, at the present
time an allowable amount is not easily
discerned or verified with existing CMS
and contractor pricing tools (for
example, there is no pricing tool
available for hospital outpatient services
paid under the outpatient prospective
payment system (OPPS)) for prepayment claim denials (where items or
services on the claim are denied, in full
or in part, before claim payment has
been made). Similarly, items and
services furnished by providers or
suppliers that are always non-covered,
as well as unlisted procedures, may not
have published allowable amounts
based on a fee schedule or a published
contractor-priced amount. Therefore, we
are proposing at § 405.1006(d)(2)(i)(B) to
continue using the provider’s or
supplier’s billed charges as the basis for
calculating the amount in controversy
for appeals of claims that are not priced
according to a CMS-published fee
schedule and do not have a published
contractor-priced amount (except as
discussed below). We note that the
method for calculating the amount in
controversy in this scenario would be
the same as under current § 405.1006(d),
and we believe that all appellants have
access to this information through
claims billing histories, remittance
advices, or the column titled ‘‘Amount
Provider [or Supplier] Charged’’ on the
Medicare Summary Notice. However,
we are soliciting comment on whether
existing tools and resources are
available that would enable providers,
suppliers, and Medicaid State agencies
to submit an allowable amount in their
request for hearing (as proposed in
Section III.A.3.g.i below) for items and
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services not subject to published fee
schedules or published contractor
priced amounts, and whether those
amounts could also be verified by
OMHA. We are also soliciting comment
on how such tools and resources could
be used in appeals filed by beneficiaries.
Current § 405.1006(d)(1) introductory
text uses ‘‘the actual amount charged
the individual for the items and services
in question’’ as the basis (starting point)
for calculating the amount in
controversy, before any reductions
described in paragraphs (d)(1)(i) and (ii)
(for any Medicare payments already
made or awarded and any deductible
and coinsurance applicable in the
particular case) occur. For the reasons
discussed above, we are proposing to
revise paragraph (d)(1) introductory text
to state that in situations other than
those described in § 405.1006(d)(3)
through (7) (discussed below), the
amount in controversy is computed as
‘‘the basis for the amount in controversy
for the items and services in the
disputed claim as defined in paragraph
(d)(2)’’, less applicable reductions
described in paragraphs (d)(1)(i) and (ii),
and are proposing to revise paragraph
(d)(2) to specify the amount that would
be used as the basis for the amount in
controversy on a situational basis. We
are also proposing at § 405.1006(d)(3)
through (7) five exceptions to the
general calculation methodology
specified in proposed paragraphs (d)(1)
and (2).
There has also been confusion in
calculating the amount in controversy
when an appealed reconsideration
involves multiple claims. Section 1869
of the Act and part 405, subpart I
provide for an appeals process in which
each claim decision is appealed and
separately adjudicated. However, in
some instances, claims are considered
together based on an appellant’s request.
To address confusion with calculating
the amount in controversy when
reconsiderations involve multiple
claims and to help ensure § 405.1006
clearly conveys that the amount in
controversy requirement must be met
for each appealed claim unless the
claim can be aggregated as discussed
below, proposed § 405.1006(d)(1) would
clarify that the amount in controversy is
based on the items or services in the
disputed ‘‘claim.’’
We are proposing to maintain the
current reduction to the calculation of
the amount in controversy in
§ 405.1006(d)(1)(i), which states that the
basis for the amount in controversy is
reduced by any Medicare payments
already made or awarded for the items
or services. In addition, current
§ 405.1006(d)(1)(ii) provides that the
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basis for the amount in controversy is
further reduced by ‘‘[a]ny deductible
and coinsurance amounts applicable in
the particular case.’’ We are proposing
to revise § 405.1006(d)(1)(ii) to read,
‘‘Any deductible and/or coinsurance
amounts that may be collected for the
items or services.’’ We believe revising
this provision is appropriate to better
align the amount at issue in the appeal
and the amount in controversy so that
in situations where a provider or
supplier is prohibited from collecting
applicable coinsurance and/or
deductible, or must refund any such
amounts already collected, the basis for
the amount in controversy is not
reduced by that amount (for example, if
a provider or supplier is held liable for
denied services under the limitation on
liability provision in section 1879 of the
Act, any amounts collected for the
denied service, including coinsurance
and/or deductible must be refunded).
As discussed above, we are proposing
at § 405.1006(d)(2)(i) that, for situations
other than those described in
§ 405.1006(d)(2)(ii) and (iii), the basis
for calculating the amount in
controversy under § 405.1006(d)(1)
would be the Medicare allowable
amount, which is the amount reflected
on the fee schedule or in the contractorpriced amount for those items or
services in the applicable jurisdiction
and place of service if there is a
published Medicare fee schedule or
published contractor-priced amount for
the items or services in the disputed
claim; or if there is no published
Medicare fee schedule or contractorpriced amount for the items or services
in the disputed claim, the basis for the
amount in controversy would be the
provider or supplier’s billed charges
submitted on the claim for the items and
services. We believe providers,
suppliers, and Medicaid State agencies
would be able to utilize existing CMS
and CMS contractor tools and resources
to determine the allowable amount for
items and services with published fee
schedule or published contractor-priced
amounts, and for items or services
without a published fee schedule or
published contractor priced amount, the
calculation methodology for the amount
in controversy would be the same as the
calculation methodology specified in
current § 405.1006(d). However, there
may be instances where a beneficiary
would appeal a claim for items and
services for which the allowable amount
would be the basis for the amount in
controversy under proposed
§ 405.1006(d)(2)(i)(A) (for example, a
claim for items or services with a
published fee schedule or published
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contractor-priced amount that does not
involve an overpayment and for which
the beneficiary has not been determined
to be financially responsible). We
believe most beneficiaries are not
familiar with published fee schedule or
contractor-priced amounts and may be
unable to determine the amount in
controversy in these circumstances with
the resources currently available to
them. However, as discussed below, we
are proposing at § 405.976(b)(7) that the
QIC include in the notice of
reconsideration a statement of whether
the amount in controversy is estimated
to meet or not meet the amount required
for an ALJ hearing, if the request for
reconsideration was filed by a
beneficiary who is not represented by a
provider, supplier, or Medicaid State
agency, and the reconsideration is
partially or fully unfavorable to the
appellant. For appeals filed by
beneficiaries, often the amount at issue
is aligned not with the Medicare
allowable amount, but rather with the
billed charges of the provider or
supplier. For example, where a
beneficiary is held financially
responsible for a denied claim under the
limitation on liability provisions in
section 1879 of the Act because he or
she received an Advance Beneficiary
Notice of Noncoverage (ABN), the
beneficiary is responsible for the billed
charges on the claim. Or, for a claim not
submitted on an assignment-related
basis that is denied, the beneficiary may
be responsible for the billed charges, or
the billed charges subject to the limiting
charge in section 1848(g) of the Act.
Medicare notifies the beneficiary of the
amount he or she may be billed for
denied services on the Medicare
Summary Notice in a column titled,
‘‘Maximum You May Be Billed.’’ For
appeals filed by a provider, supplier, or
Medicaid State agency for denied items
or services for which the beneficiary
was determined to be financially
responsible, we believe providers,
suppliers, and Medicaid State agencies
would have sufficient access to the
provider or supplier’s billing
information and Medicare claims
processing data to determine the
amount charged to the beneficiary.
Accordingly, we are proposing at
§ 405.1006(d)(2)(ii) that for any items or
services for which a beneficiary has
been determined to be financially
responsible, the basis for the amount in
controversy is the actual amount
charged to the beneficiary (or the
maximum amount the beneficiary may
be charged if no bill has been received)
for the items or services in the disputed
claim. As discussed above, this amount
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would be set forth on the Medicare
Summary Notice in the column titled
‘‘Maximum You May Be Billed.’’
We are also proposing at
§ 405.1006(d)(2)(iii) that if a beneficiary
received or may be entitled to a refund
of the amount the beneficiary previously
paid to the provider or supplier for the
items or services in the disputed claim
under applicable statutory or regulatory
authorities, the basis for the amount in
controversy would be the actual amount
originally charged to the beneficiary for
the items or services in the disputed
claim, as we believe that the amount
originally charged to the beneficiary is
more reflective of the actual amount at
issue for the beneficiary and for the
provider or supplier in this situation.
We believe appellants would have
access to and would use the same
information for determining the basis
for the amount in controversy under
paragraph § 405.1006(d)(2)(iii) as they
would under § 405.1006(d)(2)(ii).
As discussed above, we are proposing
at § 405.1006(d)(3) through (7) five
exceptions to the general methodology
used to calculate the amount in
controversy specified in
§ 405.1006(d)(1). Current
§ 405.1006(d)(2) provides that,
notwithstanding current
§ 405.1006(d)(1), when payment is made
for items or services under section 1879
of the Act or § 411.400, or the liability
of the beneficiary for those services is
limited under § 411.402, the amount in
controversy is computed as the amount
that the beneficiary would have been
charged for the items or services in
question if those expenses were not paid
under § 411.400 or if that liability was
not limited under § 411.402, reduced by
any deductible and coinsurance
amounts applicable in the particular
case. We are proposing to re-designate
current § 405.1006(d)(2) as
§ 405.1006(d)(3) and to revise the
paragraph to state that when payment is
made for items or services under section
1879 of the Act or § 411.400, or the
liability of the beneficiary for those
services is limited under § 411.402, the
amount in controversy would be
calculated in accordance with
§ 405.1006(d)(1) and (2)(i), except there
is no deduction under paragraph
(d)(1)(i) for expenses that are paid under
§ 411.400 or as a result of liability that
is limited under § 411.402. For example,
when a claim for items or service is
denied under section 1862(a)(1)(A) of
the Act because the items or services
were not reasonable and necessary for
the treatment of illness or injury or to
improve the functioning of a malformed
body member, Medicare payment may
nonetheless be made under the
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limitation on liability provisions of
§ 1879 of the Act if neither the provider/
supplier nor the beneficiary knew, or
could reasonably have been expected to
know, that payment would not be made.
In instances such as these, we are
proposing that the amount in
controversy would be calculated as if
the items or services in the disputed
claim were denied and no payment had
been made under section 1879 of the
Act. We believe this exception is
appropriate because appellants may still
wish to appeal findings of non-coverage
related to items and services for which
liability of the party was limited or
payment was made under section 1879
of the Act or § 411.400 or for which the
beneficiary was indemnified under
§ 411.402, but if these payments or
indemnifications were deducted from
the basis for the amount in controversy,
the amount in controversy could be
zero. As this exception relates only to
whether deductions are made under
§ 405.1006(d)(1)(i) for any Medicare
payments already made or awarded for
the items or service, and the amount in
controversy would otherwise be
calculated in accordance with proposed
§ 405.1006(d)(1) and (d)(2)(i), we believe
appellants would have access to and
would use the same information for
determining the amount in controversy
under § 405.1006(d)(3) as they would
under § 405.1006(d)(1) and (d)(2)(i).
Current § 405.1006 does not address
calculating the amount in controversy
for matters involving a provider or
supplier termination of a Medicarecovered item or service when the
beneficiary did not elect to continue
receiving the item or service (for
example, § 405.1206(g)(2) provides that
if a beneficiary is dissatisfied with a
QIO’s determination on his or her
discharge and is no longer an inpatient
in a hospital, the determination is
subject to the general claims appeal
process). In this circumstance, items
and services have not been furnished,
and therefore, a claim has not been
submitted. Yet the beneficiary may elect
not to continue receiving items or
services while appealing the provider or
supplier termination due to potential
financial responsibility for the items or
services. While an amount in
controversy cannot be assessed for a
period of time during which no items or
services were furnished, a beneficiary
may assert a continuing need for the
items or services based on his or her
condition at the time an appeal is heard.
To address this circumstance, we are
proposing new § 405.1006(d)(4), which
would provide that when a matter
involves a provider or supplier
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termination of Medicare-covered items
or services and the beneficiary did not
elect to continue receiving the items or
services that are disputed by a
beneficiary, the amount in controversy
is calculated as discussed above
regarding proposed (d)(1) and (d)(2)(ii)
(which addresses situations where the
beneficiary is determined to be
financially responsible), except that the
basis for the amount in controversy and
any deductible and coinsurance that
may be collected for the items or
services are calculated using the amount
the beneficiary would have been
charged if the beneficiary had received
the items or services that the beneficiary
asserts should be covered by Medicare
based on the beneficiary’s current
condition at the time an appeal is heard,
and Medicare payment was not made.
This proposal would allow the
beneficiary to pursue coverage for an
item or service and potentially meet the
amount in controversy requirement in
instances in which he or she would not
otherwise be able to pursue a hearing
before an ALJ because no items or
services have been rendered and
therefore no amount in controversy
exists because there is no disputed
claim. In these instances, the beneficiary
has been notified of a preliminary
decision by a provider or supplier that
Medicare will not cover continued
provision of the items or services in
dispute. Therefore, we believe using the
amount the beneficiary would be
charged if the beneficiary elected to
continue receiving the items or services
that the beneficiary asserts should be
covered and if Medicare payment were
not made for these items or services (in
other words, the amount the beneficiary
would be charged if the beneficiary
were financially responsible for these
items or services) is most reflective of
the actual amount in dispute. Most
beneficiary appeals of provider or
supplier terminations of Medicarecovered items or services involve the
termination of Part A services and,
therefore, we expect it would be rare
that the amount in controversy would
be less than that required for an ALJ
hearing. However, we expect that
beneficiaries wishing to determine if the
amount in controversy required for an
ALJ hearing was met could obtain from
the provider or supplier the amount the
beneficiary would be charged if the
beneficiary elected to continue receiving
the items or services and Medicare
payment were not made. In addition, as
discussed below, we are proposing at
§ 405.976(b)(7) that the QIC would
include in its notice of reconsideration
a statement of whether the amount in
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controversy is estimated to meet or not
meet the amount required for an ALJ
hearing, if the request for
reconsideration was filed by a
beneficiary who is not represented by a
provider, supplier, or Medicaid State
agency, and the reconsideration
decision was partially or fully
unfavorable.
We considered using Medicare
payable amounts for denied items and
services as the basis for the amount in
controversy calculation specified in
proposed § 405.1006(d)(1), as that
would be a more precise estimate of the
amount at issue in the appeal than
either the Medicare allowable amount or
the billed charges. Payable amounts
would take into account payment rules
related to the items and services
furnished that may increase or decrease
allowable amounts (for example,
multiple surgery reductions, incentive
payments, and competitive bidding
payments). However, CMS systems do
not currently calculate payable amounts
for denied services, and undertaking
major system changes would delay
implementation and has been
determined not to be cost effective.
While payable amounts may be a better
representation of the amount at issue in
the appeal, we believe the Medicare
allowable amount and the other amount
in controversy calculations provided in
proposed § 405.1006(d) are appropriate
and reliable estimates that align well
with the amount at issue for claims for
which a payable amount has not been
calculated.
However, for post-payment denials, or
overpayments, a payable amount has
been determined and would be the most
reliable indicator of the amount actually
at issue in the appeal. Therefore, we are
proposing new § 405.1006(d)(5) to state
that, notwithstanding the calculation
methodology in proposed paragraphs
(d)(1) and (2), when a claim appeal
involves an overpayment determination,
the amount in controversy would be the
amount of the overpayment specified in
the demand letter. In a post-payment
denial, the amount of the overpayment
identified in the demand letter is readily
available to appellants, and is the most
accurate reflection of the amount
actually at issue in the appeal. In
addition, current § 405.1006 does not
address appeals that involve an
estimated overpayment amount
determined through the use of sampling
and extrapolation. In this circumstance,
the claims sampled to determine the
estimated overpayment may not
individually meet the amount in
controversy requirement, but the
estimated overpayment determined
through the use of extrapolation may
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meet the amount in controversy
requirement. To address this
circumstance, we are also proposing in
new § 405.1006(d)(5) that when a matter
involves an estimated overpayment
amount determined through the use of
sampling and extrapolation, the
estimated overpayment as extrapolated
to the entire statistical sampling
universe is the amount in controversy.
This proposal would provide appellants
the opportunity to appeal claims that
may not individually meet the amount
in controversy requirement if such
claims were part of the sample used in
making an overpayment determination
that does meet the amount in
controversy requirement. Because the
overpayment determination reflects the
amount for which the appellant is
financially responsible, we believe it
would be appropriate to allow
appellants to appeal individual claims
in the sample that was used to
determine the overpayment. Whether an
appeal involves an individual
overpayment or an estimated
overpayment determined through the
use of sampling and extrapolation, we
believe appellants against whom an
overpayment was assessed would need
only to consult the demand letter they
received in order to determine the
amount in controversy. However, we
expect there may be circumstances
where a beneficiary wishes to appeal an
overpayment that was assessed against a
provider or supplier, and in these
situations the beneficiary may not have
a copy of the demand letter that was
received by the provider or supplier. For
this reason, and as discussed below, we
are proposing at § 405.976(b)(7) that the
QIC would include in its notice of
reconsideration a statement of whether
the amount in controversy is estimated
to meet or not meet the amount required
for an ALJ hearing, if the request for
reconsideration was filed by a
beneficiary who is not represented by a
provider, supplier, or Medicaid State
agency, and the reconsideration
decision was partially or fully
unfavorable. We are also proposing new
§ 405.1006(d)(6), which would provide
that when a beneficiary files an appeal
challenging only the computation of a
coinsurance amount, or the amount of a
remaining deductible applicable to the
items or services in the disputed claim,
the amount in controversy is the
difference between the amount of the
coinsurance or remaining deductible, as
determined by the contractor, and the
amount of the coinsurance or remaining
deductible the beneficiary believes is
correct. We believe this provision is
appropriate in these instances because,
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without this provision, the amount in
controversy determined under the
general calculation methodology in
§ 405.1006(d)(1) would be zero for a
paid claim. In addition, we believe that
the calculation proposed at
§ 405.1006(d)(6) would appropriately
reflect the amount at issue for the
beneficiary in these appeals where the
computation of a coinsurance amount,
or the amount of a remaining applicable
deductible is challenged. We believe
beneficiaries would have access to the
coinsurance and/or deductible amounts
determined by the contractor for the
paid claim on the beneficiary’s
Medicare Summary Notice, in the
column titled ‘‘Maximum You May Be
Billed,’’ and would need only to
subtract the amount of coinsurance and/
or deductible the beneficiary believes he
or she should have been charged in
order to arrive at the amount in
controversy. We expect it would be
extremely rare for a non-beneficiary
appellant to file an appeal challenging
the computation of a coinsurance
amount or the amount of a remaining
deductible.
In addition, we are proposing new
§ 405.1006(d)(7), which would provide
that for appeals of claims where the
allowable amount has been paid in full
and the appellant is challenging only
the validity of the allowable amount, as
reflected in the published Medicare fee
schedule or in the published contractor
priced amount applicable to the items or
services in the disputed claim, the
amount in controversy is the difference
between the amount the appellant
argues should have been the allowable
amount for the items or services in the
disputed claim in the applicable
jurisdiction and place of service, and
the published allowable amount for the
items or services. We believe this
provision is appropriate in these
instances because, without this
provision, the amount in controversy
determined under the general
calculation methodology in
§ 405.1006(d)(1) would be zero for such
paid claims. In addition, we believe that
the calculation proposed at
§ 405.1006(d)(7) would appropriately
reflect the amount at issue for the
appellant in these appeals. We believe
that, generally, these types of appeals
are filed by providers and suppliers who
are already familiar with the allowable
amount for the items or services in the
disputed claim based on information
obtained from published fee schedules
or contractor-priced amounts. Further,
we believe that a fee schedule or
contractor price challenge filed by a
beneficiary on a paid claim would be a
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very rare occurrence. However, as
discussed below, in the event a
beneficiary would want to file such an
appeal, the beneficiary could obtain an
estimate of the amount in controversy
from the QIC reconsideration. As
discussed further below, we are
proposing at § 405.976(b)(7) that the QIC
would include in its notice of
reconsideration a statement of whether
the amount in controversy is estimated
to meet or not meet the amount required
for an ALJ hearing, if the request for
reconsideration was filed by a
beneficiary who is not represented by a
provider, supplier, or Medicaid State
agency, and the reconsideration
decision was partially or fully
unfavorable.
In the event that a reconsideration, or
a redetermination if the appeal was
escalated from the QIC without a
reconsideration, involves multiple
claims and some or all do not meet the
amount in controversy requirement,
section 1869 of the Act states that, in
determining the amount in controversy,
the Secretary, under regulations, shall
allow two or more appeals to be
aggregated if the appeals involve the
delivery of similar or related services to
the same individual by one or more
providers or suppliers, or common
issues of law and fact arising from
services furnished to two or more
individuals by one or more providers or
suppliers. Under this authority,
§ 405.1006(e) provides for aggregating
claims to meet the amount in
controversy requirement.
The title of current § 405.1006(e)(1)
for aggregating claims when appealing a
QIC reconsideration is phrased
differently than the corresponding title
for aggregating claims when escalating a
request for a QIC reconsideration in
current § 405.1006(e)(2), which may
cause confusion. We are proposing to
revise the title to § 405.1006(e)(1) to
‘‘Aggregating claims in appeals of QIC
reconsiderations for an ALJ hearing’’ so
it clearly applies to aggregating claims
in appeals of QIC reconsiderations, and
is parallel to the phrasing used in the
title of § 405.1006(e)(2). The proposed
titles of § 405.1006(e)(1) and (e)(2), and
proposed § 405.1006(e)(2)(ii) would also
replace ‘‘to the ALJ level’’ with ‘‘for an
ALJ hearing’’ to again highlight that the
appeal of a QIC reconsideration or
escalation of a request for a QIC
reconsideration is for an ALJ hearing.
Current § 405.1006(e)(1)(ii) provides
that to aggregate claims, the request for
ALJ hearing must list all of the claims
to be aggregated. This has caused
confusion because some appellants read
current § 405.1006(e)(1)(ii) as allowing
appeals of new claims to be aggregated
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with claims in previously filed appeals,
provided the new request for hearing
lists the claims involved in the
previously filed appeals. However,
current § 405.1006(e)(2)(i), which
applies to aggregating claims that are
escalated from the QIC for a hearing
before an ALJ, requires that the claims
were pending before the QIC in
conjunction with the same request for
reconsideration. We note that in the
context of a request for hearing,
aggregating new claims with claims
from previously filed requests could
delay the adjudication of the requests
and is inconsistent with the current rule
for aggregating claims that are escalated
from the QIC. To address these issues
and bring consistency to the aggregation
provisions, we are proposing to revise
§ 405.1006(e)(1)(ii) to require the
appellant(s) to request aggregation of the
claims in the same request for ALJ
hearing or in multiple requests for an
ALJ hearing filed with the same request
for aggregation. This would allow an
individual or multiple appellants to file
either one request for an ALJ hearing for
multiple claims to be aggregated, or
multiple requests for an ALJ hearing for
the appealed claims when requesting
aggregation, while requiring them to be
filed together with the associated
request for aggregation. We are also
proposing in § 405.1006(e)(1)(iii) and
(e)(2)(iii) that an ALJ or attorney
adjudicator may determine that the
claims that a single appellant seeks to
aggregate involve the delivery of similar
or related services, or the claims that
multiple appellants seek to aggregate
involve common issues of law and fact,
but only an ALJ may determine the
claims that a single appellant seeks to
aggregate do not involve the delivery of
similar or related services, or the claims
that multiple appellants seek to
aggregate do not involve common issues
of law and fact. We are proposing this
because an attorney adjudicator
adjudicating requests for an ALJ hearing
when no hearing is conducted, as
proposed in section II.B above, would
not be permitted under this proposed
rule to dismiss a request for an ALJ
hearing due to procedural issues such as
an invalid aggregation request. Because
only an ALJ would be permitted to
dismiss a request for an ALJ hearing
because there is no right to a hearing,
which includes not meeting the amount
in controversy requirement for a
hearing, in accordance with proposed
§ 405.1052(a), an attorney adjudicator
could not make a determination that the
aggregation criteria were not met
because that determination would result
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in a dismissal of a request for an ALJ
hearing.
Current § 405.976(b)(7) requires that
the QIC notice of reconsideration
contain a statement of whether the
amount in controversy needed for an
ALJ hearing is met when the
reconsideration is partially or fully
unfavorable. We are proposing to revise
§ 405.976(b)(7) to require that the QIC
notice of reconsideration include a
statement of whether the amount in
controversy is estimated to meet or not
meet the amount required for an ALJ
hearing only if the request for
reconsideration was filed by a
beneficiary who is not represented by a
provider, supplier, or Medicaid State
agency, and the reconsideration is
partially or fully unfavorable. In line
with current practice, we are not
proposing to require that the QIC
indicate what it believes to be the exact
amount in controversy, but rather only
an estimate of whether it believes the
amount in controversy is met, because
we believe the ultimate responsibility
for determining whether the amount in
controversy required for an ALJ hearing
is met lies with appellants, subject to
verification by an ALJ or attorney
adjudicator (though, as discussed in
section II.B above, only an ALJ would be
able to dismiss a request for hearing for
failure to meet the amount in
controversy required for an ALJ
hearing). We believe that providers,
suppliers, and Medicaid State agencies
have the tools, resources, and payment
information necessary to calculate the
amount in controversy in accordance
with § 405.1006(d), and are familiar
with the allowable amounts for the
places of service in which they operate.
Furthermore, applicable plans against
whom a Medicare Secondary Payer
overpayment is assessed would have
access to the overpayment amount
specified in the demand letter, which
would be used to determine the amount
in controversy under proposed
§ 405.1006(d)(5). Thus, we do not
believe it is necessary for the QICs to
continue to provide this statement for
providers, suppliers, applicable plans,
Medicaid State agencies, or beneficiaries
represented by providers, suppliers or
Medicaid State agencies. Furthermore,
as discussed in section III.A.3.g.i below,
we are proposing that appellants, other
than beneficiaries who are not
represented by a provider, supplier, or
Medicaid State agency, include the
amount in controversy in their requests
for hearing (unless the matter involves
a provider or supplier termination of
Medicare-covered items or services that
is disputed by a beneficiary, and the
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beneficiary did not elect to continue
receiving the items or services). As
providers, suppliers, Medicaid State
agencies, applicable plans, and
beneficiaries represented by a provider,
supplier, or Medicaid State agency
would be responsible for calculating the
amount in controversy and including it
on the request for hearing as proposed
in section III.A.3.g.i, we do not believe
a statement by the QIC that indicates
only whether the amount in controversy
was or was not met adds significant
value to such appellants. Furthermore,
we expect that the Medicare allowable
amount under proposed
§ 405.1006(d)(2)(i)(A) would be the basis
for the amount in controversy in the
majority of Part B appeals filed by nonbeneficiary appellants. While QICs have
access to the amount charged to an
individual based on billed charges, the
allowable amounts for claims vary based
on where these items and services were
furnished, and the applicable fee
schedules and contractor-priced
amounts, and continuing to require the
QICs to include a statement whether the
amount in controversy needed for an
ALJ hearing is met in all instances in
which the decision is partially or fully
unfavorable to the appellant would
require substantially more work by the
QIC, and could delay reconsiderations
and increase costs to the government.
Although we are not proposing that
beneficiaries who are not represented by
a provider, supplier, or Medicaid State
agency would need to include the
amount in controversy on their requests
for hearing (as discussed later in this
preamble), we do believe there may be
instances where a beneficiary would
want to know if the amount in
controversy meets the amount required
for an ALJ hearing when deciding
whether to file a request for hearing. We
believe there may be instances where a
beneficiary who is not represented by a
provider, supplier, or Medicaid State
agency may not currently have
sufficient information to determine
whether the amount in controversy
required for an ALJ hearing is met under
proposed § 405.1006. For example,
under proposed § 405.1006(d)(2)(i)(A),
for items and services with a published
Medicare fee schedule or published
contractor-priced amount (and for
which the beneficiary was determined
to be not financially responsible), the
basis for the amount in controversy
would generally be the allowable
amount, which is the amount reflected
on the fee schedule or in the contractorpriced amount for those items or
services in the applicable jurisdiction
and place of service. Beneficiaries not
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represented by a provider, supplier, or
Medicaid State agency would not
generally be expected to be familiar
with fee schedule and contractor-priced
amounts, and we believe they may have
difficulty determining whether the
amount in controversy required for an
ALJ hearing is met in these cases. We
also believe beneficiaries not
represented by a provider, supplier, or
Medicaid State agency might be unable
to determine the amount of an
overpayment assessed against a provider
or supplier for items or services
furnished to the beneficiary for
purposes of calculating the amount in
controversy under proposed
§ 405.1006(d)(5), as the beneficiary
might not have access to the demand
letter received by the provider or
supplier, and may no longer have access
to the Medicare Summary Notice
reflecting the original payment amount.
Accordingly, because there are
situations where such beneficiaries may
not have sufficient information to
determine the amount in controversy,
we are proposing to revise
§ 405.976(b)(7) to state that the QIC
would include in its notice of
reconsideration a statement of whether
the amount in controversy is estimated
to meet or not meet the amount required
for an ALJ hearing, if the request for
reconsideration was filed by a
beneficiary who is not represented by a
provider, supplier, or Medicaid State
agency, and the reconsideration
decision was partially or fully
unfavorable.
Current § 423.1970 describes the
amount in controversy requirement for
part 423, subpart U proceedings. For the
same reasons we are proposing to revise
§ 405.1006(e)(1)(ii), we are proposing in
§ 423.1970(c)(1)(ii) and (c)(2)(ii) to
provide that a single enrollee’s or
multiple enrollees’ request for
aggregation, respectively, must be filed
at the same time the request (or
requests) for hearing for the appealed
reconsiderations is filed. In addition, we
are proposing to revise
§ 423.1970(c)(1)(ii) and
§ 423.1970(c)(2)(ii) to state that the
request for aggregation and requests for
hearing must be filed within 60 calendar
days after receipt of the notice of
reconsideration for each reconsideration
being appealed, unless the deadline is
extended in accordance with
§ 423.2014(d). This will help ensure
there is no confusion that the timely
filing requirement applies to each of the
requests for hearing filed with the
request for aggregation. Because we are
proposing to directly reference the 60
calendar day filing requirement under
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§ 423.1972(b) and the possible extension
of the filing requirement under
§ 423.2014(d), we are also proposing to
remove the current references in
§ 423.1970(c)(1)(ii) and (c)(2)(ii) to the
filing requirement in § 423.1972(b). In
addition, for the same reasons we are
proposing to revise § 405.1006(e)(1)(iii)
and (e)(2)(iii), we are proposing in
§ 423.1970(c)(1)(iii) and (c)(2)(iii) that
an ALJ or attorney adjudicator may
determine that the appeals that a single
enrollee seeks to aggregate involve the
delivery of prescription drugs to a single
enrollee, or the appeals that multiple
enrollees seek to aggregate involve the
same prescription drugs, but only an
ALJ may determine appeals that a single
enrollee seeks to aggregate do not
involve the delivery of prescription
drugs to a single enrollee, or the appeals
that multiple enrollees seek to aggregate
do not involve the same prescription
drugs. We are proposing to replace
‘‘prescription’’ in current
§ 423.1970(c)(2)(iii) with ‘‘prescription
drugs’’ in proposed § 423.1970(c)(2)(iii)
for consistency with current and
proposed § 423.1970(c)(1)(iii). Finally,
we are also proposing to correct the
spelling of ‘‘prescription’’ in current
§ 423.1970(c)(2)(iii).
Current § 422.600(b) provides that the
amount in controversy for appeals of
reconsidered determinations to an ALJ
(under the Part C Medicare Advantage
program), is computed in accordance
with part 405. However, if the basis for
the appeal is the MAO’s refusal to
provide services, current § 422.600(c)
provides that the projected value of
those services are used to compute the
amount in controversy. We are not
proposing to revise these provisions
because we believe the proposed
revisions to § 405.1006 described above
encompass and have application to the
scenarios appealed under part 422,
subpart M. In particular, we note that as
is the case under current § 405.1006, if
an enrollee received items or services
and is financially responsible for
payment because the MAO has refused
to cover the item or services, the amount
in controversy would be calculated
using the billed charges as the basis for
the amount in controversy, as provided
in proposed § 405.1006(d)(2)(ii). If the
enrollee did not receive the items or
services, the provisions of current
§ 422.600(c) would apply. We also note
that current §§ 422.622(g)(2) and
422.626(g)(3) provides for an appeal to
an ALJ, the Council, or federal court of
an IRE’s affirmation of a termination of
provider services ‘‘as provided for under
[part 422, subpart M],’’ thus triggering
the amount in controversy rules in
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422.600, which cross-reference part 405
(that is, the rules proposed here).
Proposed § 405.1006 would address
scenarios appealed under part 422,
subpart M that are not clearly addressed
in current § 405.1006, such as provider
service terminations, which would be
addressed in proposed § 405.1006(d)(4),
and coinsurance and deductible
challenges, which would be addressed
in proposed § 405.1006(d)(6).
Current § 478.44(a) also references
back to part 405 provisions for
determining the amount in controversy
when requesting an ALJ hearing after a
QIO reconsidered determination. We
have proposed revisions to § 478.44 in
section III.D.3, below, to update part 405
references, but we are not proposing in
§ 478.44 to revise how the current or
proposed part 405 provision would be
applied in calculating the amount in
controversy. Similar to the part 422,
subpart M provisions discussed above,
we believe the proposed revisions to
§ 405.1006 described above encompass
and have application to the scenarios
appealed under part 478, subpart B.
We are inviting public comments on
these proposals. If you choose to
comment on issues in this section,
please include the caption ‘‘Amount in
controversy required for an ALJ
hearing’’ at the beginning of your
comment.
e. Parties to an ALJ Hearing (§§ 405.1008
and 423.2008)
Current §§ 405.1008 and 423.2008
discuss the parties to an ALJ hearing.
Because current §§ 405.1002(a) and
423.2002(a) already address who may
request a hearing before an ALJ after a
QIC or IRE issues a reconsideration and
current § 405.1002(b) addresses who
may request escalation of a request for
a QIC reconsideration, we are proposing
to remove current §§ 405.1008(a) and
423.2008(a).
We are proposing to retain and revise
the language as discussed below in
current §§ 405.1008(b) and 423.2008(b),
but remove the paragraph designation.
Current §§ 405.1008(b) and 423.2008(b)
identify the parties ‘‘to the ALJ
hearing,’’ but this could be read to be
limited to parties to an oral hearing, if
a hearing is conducted. To address this
potential confusion, we are proposing to
revise §§ 405.1008 and 423.2008 to
replace ‘‘parties to an ALJ hearing’’ with
‘‘parties to the proceedings on a request
for an ALJ hearing’’ and ‘‘party to the
ALJ hearing’’ with ‘‘party to the
proceedings on a request for an ALJ
hearing.’’ Likewise, we also are
proposing to revise the titles to
§§ 405.1008 and 423.2008 from ‘‘Parties
to an ALJ hearing’’ to ‘‘Parties to the
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proceedings on a request for an ALJ
hearing.’’
We are inviting public comments on
these proposals. If you choose to
comment the proposals in this section,
please include the caption ‘‘Parties to an
ALJ hearing’’ at the beginning of your
comment.
f. CMS and CMS Contractors as
Participants or Parties in the
Adjudication Process (§§ 405.1010,
405.1012, and 423.2010)
Consistent with section 1869(c)(3)(J)
of the Act, §§ 405.1010 and 405.1012
allow CMS and its contractors to elect
to be a participant or a party to a Part
A or Part B hearing before an ALJ.
Current § 423.1010 allows CMS, a Part
D plan sponsor, or an IRE to request to
be a participant in the proceedings of a
Part D hearing before an ALJ. Since
current §§ 405.1010, 405.1012, and
423.2010 were added, CMS and its
contractors, including the Part D IRE,
and Part D plan sponsors, have assisted
the ALJ hearing process by clarifying
factual and policy issues, which
provides ALJs with more information to
resolve the issues on appeals. However,
as we have gained experience with CMS
and these entities as participants and
parties to hearings, we have heard from
ALJs and stakeholders that additional
parameters are needed to help ensure
hearings with the entities are as efficient
as possible; expectations and roles are
clear; and the entities have an
opportunity to assist with appeals for
which no hearing is conducted.
Therefore, we are proposing
significant revisions to §§ 405.1010,
405.1012, and 423.2010 to achieve these
objectives.
Proposed §§ 405.1010 (When CMS or
its contractors may participate in the
proceedings on a request for an ALJ
hearing), 405.1012 (When CMS or its
contractors may be a party to a hearing),
and 423.2010 (When CMS, the IRE, or
Part D plan sponsor may participate in
the proceedings on a request for an ALJ
hearing) would be reorganized and
aligned for clarity, and revised to
improve the participation process. The
proposed revised sections would be
similarly structured to address when an
entity may elect or request to participate
in the proceedings on a request for an
ALJ hearing, or be a party to a hearing;
how elections or requests are made; the
roles and responsibilities of CMS and its
contractors; limitations on hearing
participation; and invalid elections or
requests.
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i. Section 405.1010: When CMS or Its
Contractors May Participate in the
Proceedings on a Request for an ALJ
Hearing
Current § 405.1010(a) provides that an
ALJ may request, but may not require,
CMS and/or its contractors to
participate in any proceedings before
the ALJ, including the oral hearing, if
any, and CMS or its contractors may
elect to participate in the hearing
process. Under current § 405.1010(b), if
that election is made, CMS or its
contractor must advise the ALJ, the
appellant, and all other parties
identified in the notice of hearing of its
intent to participate no later than 10
calendar days after receiving the notice
of hearing. Section 405.1010(c) sets
forth what participation includes and
§ 405.1010(d) states that participation
does not include CMS or its contractor
being called as a witness during the
hearing. Section 405.1010(e) requires
CMS or its contractors to submit any
position papers within the time frame
designated by the ALJ. Finally,
§ 405.1010(f) states that the ALJ cannot
draw any adverse inferences if CMS or
a contractor decides not to participate in
any proceedings before an ALJ,
including the hearing.
The reference to the period in which
an election to participate must be filed
beginning upon receipt of the notice of
hearing in current § 405.1010(b) has
caused confusion when CMS or its
contractors attempt to enter proceedings
before a hearing is scheduled, or when
no notice of hearing is necessary
because an appeal may be decided on
the record. To help ensure that CMS and
its contractors have the opportunity to
enter the proceedings with minimal
disruption to the adjudication process
prior to a hearing being scheduled or
when a hearing may not be conducted,
we are proposing in § 405.1010(a)(1) to
provide that CMS or its contractors may
elect to participate in the proceedings
on a request for an ALJ hearing upon
filing a notice of intent to participate in
accordance with paragraph (b), at either
of, but not later than, two distinct points
in the adjudication process described in
paragraph (b)(3).
As provided in current § 405.1010(a)
and (f), we are proposing at
§ 405.1010(a)(2) that an ALJ may request
but may not require CMS and/or one or
more of its contractors to participate in
any proceedings before the ALJ,
including the oral hearing, if any; and
the ALJ cannot draw any adverse
inferences if CMS or the contractor
decides not to participate in the
proceedings.
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We are proposing in § 405.1010(b) to
address how CMS or a contractor makes
an election to participate in an appeal,
before or after receipt of a notice of
hearing or when a notice of hearing is
not required. Under proposed
§ 405.1010(b)(1), we are proposing that
if CMS or a contractor elects to
participate before receipt of a notice of
hearing (such as during the 30 calendar
day period after being notified that a
request for hearing was filed as
proposed in § 405.1010(b)(3)(i)) or when
a notice of hearing is not required, CMS
or the contractor must send written
notice of its intent to participate to the
parties who were sent a copy of the
notice of reconsideration, and to the
assigned ALJ or attorney adjudicator, as
proposed in section II.B above, or if the
appeal is not yet assigned, to a designee
of the Chief ALJ. Proposed
§ 405.1010(b)(1) would provide for
sending the written notice of intent to
participate to an ALJ or attorney
adjudicator assigned to an appeal
because, as we discuss in proposed in
section II.B, an attorney adjudicator also
would have the authority to issue
decisions on a request for an ALJ
hearing when no hearing is conducted,
and in accordance with proposed
§ 405.1010, CMS or its contractors are
permitted to participate in the
proceedings on such a request. Proposed
§ 405.1010(b)(1) would also provide for
sending the notice of intent to
participate to a designee of the Chief
ALJ if a request for an ALJ hearing is not
yet assigned to an ALJ or attorney
adjudicator because CMS or a contractor
could file an election to be a participant
in the proceedings before the
assignment process is complete.
Proposed § 405.1010(b)(1) would help
ensure that the potential parties to a
hearing, if a hearing is conducted,
would receive notice of the intent to
participate, and also help ensure that
adjudicators who are assigned to an
appeal after an election is made would
be aware of the election. Because only
an ALJ may conduct a hearing and the
parties to whom a notice of hearing is
sent may differ from the parties who
were sent a copy on the notice of
reconsideration, we are proposing at
§ 405.1010(b)(2) that if CMS or a
contractor elects to participate after
receiving a notice of hearing, CMS or
the contractor would send written
notice of its intent to participate to the
ALJ and the parties who were sent a
copy of the notice of hearing.
Under proposed § 405.1010(b)(3)(i),
CMS or a contractor would have an
initial opportunity to elect to be a
participant in an appeal within 30
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calendar days after notification that a
request for hearing has been filed with
OMHA, if no hearing is scheduled. CMS
and its contractors have the capability to
see that a QIC reconsideration had been
appealed to OMHA in the case
management system used by QICs. This
system would provide constructive
notice to the QICs when the system
indicates an appeal has been filed with
OMHA, which OMHA can monitor
through the date that the
reconsideration data is transferred to
OMHA to adjudicate the request for an
ALJ hearing. Under proposed
§ 405.1010(b)(3)(ii), a second
opportunity to elect to be a participant
in an appeal would become available if
a hearing is scheduled; as in the current
rule, CMS or a contractor would have 10
calendar days after receiving the notice
of hearing to make the election.
We considered allowing CMS or a
contractor to make an election at any
time prior to a decision being issued if
a hearing was not scheduled, or sending
a notice that a decision would be issued
without a hearing and establishing an
election period after such notice.
However, both of these options would
disrupt and delay the adjudication
process, as well as add administrative
burdens on OMHA. We believe the 30
calendar day period after notification
that a request for hearing was filed is
sufficient time for CMS or a contractor
to determine whether to elect to be a
participant in the appeal while the
record is reviewed for case development
and to prepare for the hearing, or
determine whether a decision may be
appropriate based on the record in
accordance with § 405.1038.
We are proposing to consolidate
current § 405.1010(c) through (e) in
proposed § 405.1010(c) to address the
roles and responsibilities of CMS or a
contractor as a participant. Proposed
§ 405.1010(c)(1) would incorporate
current § 405.1010(c), which provides
that participation may include filing
position papers or providing testimony
to clarify factual or policy issues, but it
does not include calling witnesses or
cross-examining a party’s witnesses.
However, we are proposing to revise
§ 405.1010(c) to state in § 405.1010(c)(1)
that participation may include filing
position papers ‘‘and/or’’ providing
testimony to emphasize that either or
both may be done, and to state that
participation would be subject to
proposed § 405.1010(d)(1) through (3)
(discussed below). We are proposing to
incorporate current § 405.1010(d) in
proposed § 405.1010(c)(2) to provide
that when CMS or a contractor
participates in a hearing, they may not
be called as witnesses and, thus, are not
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subject to examination or crossexamination by parties to the hearing.
However, to be clear about how a party
and the ALJ may address statements
made by CMS or a contractor during the
hearing given that limitation, we also
are proposing in § 405.1010(c)(2) that
the parties may provide testimony to
rebut factual or policy statements made
by the participant, and the ALJ may
question the participant about the
testimony.
We are proposing to incorporate
current § 405.1010(e) in proposed
§ 405.1010(c)(3) with certain revisions
as discussed below. Current
§ 405.1010(e) states that CMS or its
contractor must submit any position
papers within the time frame designated
by the ALJ. We are proposing in
§ 405.1010(c)(3) to include written
testimony in the provision, establish
deadlines for submission of position
papers and written testimony that
reflect the changes in participation
elections in proposed 405.1010(b), and
require that copies of position papers
and written testimony be sent to the
parties. Specifically, we are proposing
in § 405.1010(c)(3)(i) that CMS or a
contractor position paper or written
testimony must be submitted within 14
calendar days of an election to
participate if no hearing has been
scheduled, or no later than 5 calendar
days prior to the scheduled hearing
unless additional time is granted by the
ALJ. We are proposing to add ‘‘written
testimony’’ to recognize that CMS or a
contractor may submit written
testimony as a participant, in addition
to providing oral testimony at a hearing.
We are proposing to require position
papers and written testimony be
submitted within 14 calendar days after
an election if no hearing is scheduled to
help ensure the position paper and/or
written testimony are available when
determinations are made to schedule a
hearing or issue a decision based on the
record in accordance with § 405.1038.
We also are proposing to require that if
a hearing is scheduled, position papers
and written testimony be submitted no
later than 5 calendar days prior to the
hearing (unless the ALJ grants
additional time) to help ensure the ALJ
and the parties have an opportunity to
review the materials prior to the
hearing. Additionally, under proposed
§ 405.1010(c)(3)(ii), CMS or a contractor
would need to send a copy of any
position paper or written testimony
submitted to OMHA to the parties who
were sent a copy of the notice of
reconsideration if the position paper or
written testimony is submitted to
OMHA before receipt of a notice of
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hearing, or to the parties who were sent
a copy of the notice of hearing if the
position paper or written testimony is
submitted after receipt of a notice of
hearing. Current § 405.1010 does not
address the repercussions of a position
paper not being submitted in
accordance with the section. Therefore,
we are proposing in § 405.1010(c)(3)(iii)
that a position paper or written
testimony would not be considered in
deciding an appeal if CMS or a
contractor fails to send a copy of its
position paper or written testimony to
the parties, or fails to submit its position
paper or written testimony within the
established time frames. This would
help ensure CMS or contractor position
papers and written testimony are
submitted timely and shared with the
parties.
Current §§ 405.1010 does not limit the
number of entities that may elect to be
participants, which currently includes
participating in a hearing if a hearing is
conducted, and current § 405.1012 does
not limit the number of entities that may
elect to be a party to a hearing. This has
resulted in hearings for some appeals
being difficult to schedule and taking
longer to conduct due to multiple
elections. To address these issues, we
are proposing at § 405.1010(d)(1) that
when CMS or a contractor has been
made a party to the hearing under
§ 405.1012, CMS or a contractor that
elected to be a participant under
§ 405.1010 may not participate in the
oral hearing, but may file a position
paper and/or written testimony to
clarify factual or policy issues in the
case (oral testimony and attendance at
the hearing would not be permitted).
Similarly, we are proposing at
§ 405.1010(d)(1) that CMS or a
contractor that elected to be a party to
the hearing, but was made a participant
under § 405.1012(d)(1), as discussed
below, would also be precluded from
participating in the oral hearing, but
would be permitted to file a position
paper and/or oral testimony to clarify
factual or policy issues in the case. We
are proposing at § 405.1010(d)(2) that if
CMS or a contractor did not elect to be
a party to the hearing under § 405.1012,
but more than one entity elected to be
a participant under § 405.1010, only the
first entity to file a response to the
notice of hearing as provided under
§ 405.1020(c) may participate in the oral
hearing, but additional entities that filed
a subsequent response to the notice of
hearing could file a position paper and/
or written testimony to clarify factual or
policy issues in the case (though they
would not be permitted to attend the
hearing or provide oral testimony). We
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are proposing that the first entity to file
a response to the notice of hearing as
provided under § 405.1020(c) may
participate in the hearing for
administrative efficiency. Under this
approach, if multiple entities elected to
participate in the proceedings prior to
the issuance of a notice of hearing, in
accordance with proposed
§ 405.1010(b)(1), any of these entities
wishing to participate in the oral
hearing would need to indicate this
intention in the response to the notice
of hearing. If more than one entity
indicated its intention to attend and
participate in the oral hearing, only the
first entity to file its response would be
permitted to do so. The remaining
entities would be permitted only to file
a position paper and/or written
testimony (unless the ALJ grants leave
to additional entities to attend the
hearing, as discussed below). We
considered an alternate proposal of the
first entity that made an election to
participate being given priority for
participating in the hearing, but believe
that would result in other participants
being uncertain whether they will be
participating in the hearing until as few
as 5 days prior to the hearing. We also
considered a process in which the ALJ
would assess which participant that
responded to the notice of hearing
would be most helpful to the ALJ at the
hearing, or in the alternative, permitting
all participants to be at the hearing
unless the ALJ determined a participant
is not necessary for the hearing, but both
of these approaches would add
administrative burden to the ALJ and
could result in participants and parties
being uncertain of which participants
will be at the hearing until shortly
before the hearing. We welcome
comments on the alternatives
considered above, and other potential
alternatives.
Notwithstanding the limitations on
CMS and CMS contractor participation
in proposed § 405.1010(d)(1) and (2),
proposed § 405.1010(d)(3) would
provide the ALJ with the necessary
discretion to allow additional
participation in the oral hearing when
the ALJ determines an entity’s
participation is necessary for a full
examination of the matters at issue. For
example, if an appeal involves LCDs
from multiple MAC jurisdictions, the
ALJ may determine that allowing
additional MACs to participate in a
hearing is necessary for a full
examination of the matters at issue.
Similarly, if an overpayment
determined through the use of a
statistical sample and extrapolation is at
issue, the ALJ may determine that
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allowing the contractor that conducted
the sampling to participate in the
hearing is necessary to address issues
related to the sampling and
extrapolation, in addition to another
contractor that made an election to
clarify the policy and factual issues
related to the merits of claims in the
sample.
Currently, there are no provisions in
§ 405.1010 to address the possibility of
CMS or a contractor making an invalid
election. We are proposing to revise
§ 405.1010(e) to add new provisions to
establish criteria for when an election
may be deemed invalid and provide
standards for notifying the entity and
the parties when an election is deemed
invalid. Proposed § 405.1010(e)(1)
would provide that an ALJ or attorney
adjudicator may determine an election
is invalid if the election was not timely
filed or the election was not sent to the
correct parties. This would help ensure
that CMS and its contractors make
timely elections and inform parties of
elections. To provide notice to the entity
and the parties that an election was
deemed invalid, proposed
§ 405.1010(e)(2) would require a written
notice of an invalid election be sent to
the entity that submitted the election
and the parties who are entitled to
receive notice of the election. If no
hearing is scheduled for the appeal or
the election was submitted after the
hearing occurred, proposed
§ 405.1010(e)(2)(i) would provide that
the notice of an invalid election be sent
no later than the date the decision,
dismissal, or remand notice is mailed. If
a hearing is scheduled for the appeal,
proposed § 405.1010(e)(2)(ii) would
provide that the written notice of an
invalid election is sent prior to the
hearing, and that if the notice would be
sent fewer than 5 calendar days before
the hearing is scheduled to occur, oral
notice must be provided to the entity,
and the written notice must be sent as
soon as possible after the oral notice is
provided.
We are inviting public comments on
these proposals. If you choose to
comment on the proposals in this
section, please include the caption
‘‘Section 405.1010: When CMS or its
contractors may participate in the
proceedings on a request for an ALJ
hearing’’ at the beginning of your
comment.
ii. Section 423.2010: When CMS, the
IRE, or Part D Plan Sponsors May
Participate in the Proceedings on a
Request for an ALJ Hearing
Current § 423.2010 is similar to
current § 405.1010, except that CMS, the
IRE, or the Part D plan sponsor may
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only request to participate, and the time
periods to request to participate are
shorter than the time periods to elect to
participate under § 405.1010, which
provides the ALJ with time to consider
the request to participate and make a
determination on whether to allow
participation by the entity. In addition,
current § 423.2010 addresses
participation in Part D expedited
appeals. Like proposed § 405.1010(a),
we are proposing at § 423.2010(a) to
provide CMS, the IRE, and the Part D
plan sponsor with an opportunity to
participate in the proceedings on a
request for an ALJ hearing at two
distinct points in the adjudication
process, but the current policy of
requiring the entity to request to
participate is maintained. We are
proposing at § 423.2010(b)(3)(i) and (ii)
that, if no hearing is scheduled, CMS,
the IRE and/or the Part D plan sponsor
would have an initial opportunity to
request to be a participant in an appeal
within 30 calendar days after
notification that a standard request for
hearing was filed with OMHA, or within
2 calendar days after notification that a
request for an expedited hearing was
filed. The initial 30 calendar day period
after notification that a standard request
for hearing was filed with OMHA would
be the same time frame provided under
§ 405.1010 for initial CMS and
contractor elections, and we believe that
30 calendar day period after notification
that a request for hearing was filed is
sufficient time for CMS, the IRE, and the
Part D plan sponsor to determine
whether to request to be a participant in
the proceedings and for the request to be
considered and granted or denied as the
case is reviewed to determine whether
a decision may be appropriate based on
the record in accordance with
§ 423.2038. We believe the 2 calendar
day period after notification that an
expedited request for hearing was filed
is a reasonable period of time for CMS,
the IRE, or the Part D plan sponsor to
determine whether to request to be a
participant in the proceedings given the
10-day adjudication time frame. We are
proposing at § 423.2010(b)(3)(iii) and
(iv) to provide a second opportunity to
request to be a participant in an appeal
if a hearing is scheduled. We are
proposing at § 423.2010(b)(3)(iii) that if
a non-expedited hearing is scheduled,
CMS, the IRE, or the Part D plan sponsor
would continue to have 5 calendar days
after receiving the notice of hearing to
make the request. We are proposing at
§ 423.2010(b)(3)(iv) that if an expedited
hearing is scheduled, CMS, the IRE, or
the Part D plan sponsor would continue
to have 1 calendar day after receiving
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43813
the notice of hearing to make the
request. These time frames are carried
over from current § 423.2010(b)(1) and
(b)(3), and provide the ALJ with time to
consider the request and notify the
entity of his or her decision on the
request to participate. As provided in
current § 423.2010(a) and (g), we are
proposing at § 423.2010(a)(2) to provide
that an ALJ may request but may not
require CMS, the IRE, or the Part D plan
sponsor to participate in any
proceedings before the ALJ, including
the oral hearing, if any, and that the ALJ
may not draw any adverse inferences if
CMS, the IRE, or the Part D plan sponsor
declines to be a participant to the
proceedings.
The standards governing how an
election is made in proposed
§ 405.1010(b) would be adopted in
proposed § 423.2010(b) governing how a
request to participate is made, except
that an oral request to participate could
be made for an expedited hearing, and
OMHA would notify the enrollee of the
request to participate in such cases.
Current § 423.2010(b)(2) and (b)(4)
provide that an ALJ will notify an entity
requesting to participate of the decision
on the request within 5 calendar days
for a request related to a non-expedited
hearing, or 1 calendar day for a request
related to an expedited hearing. These
time frames would be incorporated in
proposed § 423.2020(c). In addition,
proposed § 423.2020(c)(1) would
provide that if no hearing is scheduled,
the notification is made at least 20
calendar days before the ALJ or attorney
adjudicator (as proposed in section II.B
above) issues a decision, dismissal, or
remand. This would provide the
participant with time to submit a
position paper in accordance with
proposed § 423.2010(d)(3)(i), as
discussed below. Current § 423.2010(c)
would also be incorporated into
proposed § 423.2010(c), so that the
provision clearly states that the assigned
ALJ or attorney adjudicator (as proposed
in section II.B above) has discretion to
not allow CMS, the IRE, or the Part D
plan sponsor to participate. Proposed
§ 423.2010(c) would provide that an
attorney adjudicator as well as the ALJ
may make a decision on a request to
participate because a request to
participate may be submitted for
appeals that may be assigned to an
attorney adjudicator and those appeals
could also benefit from CMS, the IRE, or
the Part D plan sponsor participation in
the proceedings. We are not proposing
to limit the number of participants in a
hearing similar to proposed
§ 405.1010(d) because the ALJ has the
discretion to deny a request to
participate under § 423.1010 and may
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therefore deny a request to participate if
the ALJ determines that a hearing would
have sufficient participant involvement
or does not need participant
involvement.
We are proposing at § 423.2010(d) to
consolidate current § 423.2010(d)
through (f), to address the roles and
responsibilities of CMS, the IRE, or the
Part D plan sponsor as a participant.
Specifically, we are proposing at
§ 423.2010(d)(1) to generally incorporate
current § 423.2010(d), which provides
that participation may include filing
position papers or providing testimony
to clarify factual or policy issues, but it
does not include calling witnesses or
cross-examining a party’s witnesses.
However, we are proposing in
§ 423.2010(d)(1) that participation may
include filing position papers ‘‘and/or’’
providing testimony to emphasize that
either or both may be done, and to
remove the limitation that testimony
must be written because participation
may include providing oral testimony
during the hearing. We are proposing at
§ 423.2010(d)(2) to incorporate current
§ 423.2010(e), which provides that when
participating in a hearing, CMS, the IRE,
or the Part D plan sponsor may not be
called as a witness during the hearing
and, thus, are not subject to examination
or cross-examination by the enrollee at
the hearing. However, to be clear about
how an enrollee and the ALJ may
address statements made by CMS, the
IRE, or the Part D plan sponsor during
the hearing given that limitation, we
also are proposing in § 423.2010(d)(2)
that the enrollee may rebut factual or
policy statements made by the
participant, and the ALJ may question
the participant about its testimony.
We are proposing at § 423.2010(d)(3)
to incorporate current § 423.2010(f) with
certain revisions as discussed below.
Current § 423.2010(f) states that CMS,
the IRE, and/or the Part D plan sponsor
must submit any position papers within
the time frame designated by the ALJ.
We are proposing in § 423.2010(d)(3) to
include written testimony in the
provision, establish deadlines for
submission of position papers and
written testimony that reflect the
changes in participation elections in
proposed 423.2010(b), and require that
copies of position papers and written
testimony be sent to the enrollee.
Specifically, we are proposing in
§ 423.2010(d)(3) that, unless the ALJ or
attorney adjudicator grants additional
time to submit a position paper or
written testimony, a CMS, the IRE, or
the Part D plan sponsor position paper
or written testimony must be submitted
within 14 calendar days for a standard
appeal or 1 calendar day for an
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expedited appeal after receipt of the
ALJ’s or attorney adjudicator’s decision
on a request to participate if no hearing
has been scheduled, or no later than 5
calendar days prior to a non-expedited
hearing or 1 calendar day prior to an
expedited hearing. We are proposing to
add ‘‘written testimony’’ to recognize
that CMS, the IRE, or the Part D plan
sponsor or a contractor may submit
written testimony as a participant, in
addition to providing oral testimony at
a hearing. We are proposing to require
that position papers and written
testimony be submitted within 14
calendar days for a standard appeal or
1 calendar day for an expedited appeal
after receipt of the ALJ’s or attorney
adjudicator’s decision on a request to
participate if no hearing has been
scheduled to help ensure the position
paper and/or written testimony are
available when determinations are made
to schedule a hearing or issue a decision
based on the record in accordance with
§ 405.1038. We also are proposing to
require that if a hearing is scheduled,
position papers and written testimony
be submitted no later than 5 calendar
days prior to a non-expedited hearing or
1 calendar day prior to an expedited
hearing (unless the ALJ grants
additional time) to help ensure the ALJ
and the enrollee have an opportunity to
review the materials prior to the
hearing. Similar to proposed
§ 405.1010(c)(3)(iii), we also are
proposing at § 423.2010(d)(3)(ii) that a
copy of the position paper or written
testimony must be sent to the enrollee,
and at § 423.2010(d)(iii) that a position
paper or written testimony would not be
considered in deciding an appeal if
CMS, the IRE, and/or the Part D plan
sponsor fails to send a copy of the
position paper or written testimony to
the enrollee or fails to submit the
position paper or written testimony
within the established time frames. This
would help ensure CMS, IRE, or Part D
plan sponsor position papers and
written testimony are submitted timely
and shared with the enrollee.
Currently, there are no provisions in
§ 423.2010 to address the possibility of
CMS, the IRE, and/or the Part D plan
sponsor making an invalid request to
participate. We are proposing to revise
§ 423.2010(e) to add new provisions to
establish criteria for when a request to
participate may be deemed invalid and
provide standards for notifying the
entity and the enrollee when a request
to participate is deemed invalid.
Proposed § 423.2010(e)(1) would
provide that an ALJ or attorney
adjudicator may determine a request to
participate is invalid if the request to
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participate was not timely filed or the
request to participate was not sent to the
enrollee. This would help ensure that
CMS, the IRE, and/or the Part D plan
sponsor make timely requests to
participate and inform the enrollee of
requests. To provide notice to the entity
and the enrollee that a request to
participate was deemed invalid,
proposed § 423.2010(e)(2) would require
a written notice of an invalid request be
sent to the entity that made the request
and the enrollee. If no hearing is
scheduled for the appeal or the request
was made after the hearing occurred,
proposed § 423.2010(e)(2)(i) would
provide that the notice of an invalid
request be sent no later than the date the
decision, dismissal, or remand order is
mailed. If a non-expedited hearing is
scheduled for the appeal, proposed
§ 423.2010(e)(2)(ii) would provide that
written notice of an invalid request is
sent prior to the hearing, and that if the
notice would be sent fewer than 5
calendar days before the hearing, oral
notice must be provided to the entity,
and the written notice must be sent as
soon as possible after the oral notice is
provided. If an expedited hearing is
scheduled for the appeal, proposed
§ 423.2010(e)(2)(iii) would provide that
oral notice of an invalid request must be
provided to the entity, and the written
notice must be sent as soon as possible
after the oral notice is provided. We are
proposing to require the oral notice for
expedited hearings because the very
short time frames involved in expedited
hearing proceedings often do not allow
for delivery of a written notice and the
oral notice will help ensure the entity is
made aware of the invalid request prior
to the hearing.
We are inviting public comments on
these proposals. If you choose to
comment on the proposals in this
section, please include the caption
‘‘Section 423.2010: When CMS, the IRE,
or Part D plan sponsors may participate
in the proceedings on a request for an
ALJ hearing’’ at the beginning of your
comment.
iii. Section 405.1012: When CMS or Its
Contractors May Be a Party to a Hearing
Current § 405.1012(a) states that CMS
and/or its contractors may be a party to
an ALJ hearing unless the request for
hearing is filed by an unrepresented
beneficiary. Current § 405.1012(b) states
that CMS and/or the contractor(s)
advises the ALJ, appellant, and all other
parties identified in the notice of
hearing that it intends to participate as
a party no later than 10 calendar days
after receiving the notice of hearing.
Current § 405.1012(c) states that, when
CMS or its contractors participate in a
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hearing as a party, it may file position
papers, provide testimony to clarify
factual or policy issues, call witnesses
or cross-examine the witnesses of other
parties. CMS or its contractor(s) will
submit any position papers within the
time frame specified by the ALJ. CMS or
its contractor(s), when acting as parties,
may also submit additional evidence to
the ALJ within the time frame
designated by the ALJ. Finally, current
§ 405.1012(d) states that the ALJ may
not require CMS or a contractor to enter
a case as a party or draw any adverse
inferences if CMS or a contractor
decides not to enter as a party. As stated
previously, we are proposing significant
changes to § 405.1012.
Current § 405.1012 does not limit the
number entities that may elect to be a
party to the hearing. This has resulted
in hearings for some appeals being
difficult to schedule and taking longer
to conduct due to multiple elections. To
address these issues, we are proposing
at § 405.1012(a)(1), except as provided
in proposed paragraph (d) discussed
below, to only allow either CMS or one
of its contractors to elect to be a party
to the hearing (unless the request for
hearing is filed by an unrepresented
beneficiary, which precludes CMS and
its contractors from electing to be a
party to the hearing). Current
§ 405.1012(b) states that CMS or a
contractor advises the ALJ, appellant,
and all other parties identified in the
notice of hearing that it intends to
participate as a party no later than 10
calendar days after receiving the notice
of hearing. We are proposing at
§ 405.1012(a) to incorporate and revise a
portion of current § 405.1012(b), to
require that an election to be a party
must be filed no later than 10 calendar
days after the QIC receives the notice of
hearing, because notices of hearing are
sent to the QIC in accordance with
§ 405.1020(c) (the remaining portion of
current § 405.1012(b) is incorporated
with revisions into proposed
§ 405.1012(b), as discussed below).
Current § 405.1012 does not have a
provision similar to current
§ 405.1010(a), which states that an ALJ
may request that CMS and/or one or
more of its contractors participate in the
proceedings, but current § 405.1012(d)
does provide that the ALJ may not
require CMS or a contractor to enter a
case as a party or draw any adverse
inference if CMS or a contractor decided
not to enter as a party. In practice, ALJs
do at times request that CMS or a
contractor elect to be a party to the
hearing, in conjunction with a request
for participation under current
§ 405.1010(a). To align the provisions
and reflect ALJ practices, we are
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proposing at § 405.1012(a)(2) to state
that an ALJ may request but not require
CMS and/or one or more of its
contractors to be a party to the hearing.
We also are proposing in
§ 405.1012(a)(2) to incorporate current
§ 405.1012(d) to provide that that an ALJ
cannot draw any adverse inferences if
CMS or a contractor decides not to enter
as a party.
We are proposing at § 405.1012(b) to
address how CMS or a contractor elects
to be a party to the hearing. We are
proposing to follow the same process in
current § 405.1012(b) so that under
proposed § 405.1012(b), CMS or the
contractor would be required to send
written notice of its intent to be a party
to the hearing to the ALJ and the parties
identified in the notice of hearing,
which includes the appellant.
We are proposing to set forth the roles
and responsibilities of CMS or a
contractor as a party in § 405.1012(c).
Proposed § 405.1012(c)(1) would
incorporate current § 405.1012(c) with
some changes in wording, both of which
provide that as a party to the hearing,
CMS or a contractor may file position
papers, submit evidence, provide
testimony to clarify factual or policy
issues, call witnesses, or cross-examine
the witnesses of other parties. We are
proposing in § 405.1012(c)(2) to include
written testimony, such as an affidavit
or deposition, in the provision; establish
deadlines for submission of position
papers, written testimony, and
evidence; and require that copies of
position papers, written testimony, and
evidence be sent to the parties that were
sent a copy of the notice of hearing.
Specifically, we are proposing in
§ 405.1012(c)(2)(i) and (c)(2)(ii) that any
position papers, written testimony, and
evidence must be submitted no later
than 5 calendar days prior to the
hearing, unless the ALJ grants
additional time to submit the materials,
and copies must be sent to the parties
who were sent a copy of the notice of
hearing. We are proposing to add
‘‘written testimony’’ to recognize that
CMS or a contractor may submit written
testimony, in addition to providing oral
testimony at a hearing. We also are
proposing to require that position
papers, written testimony, and/or
evidence be submitted no later than 5
calendar days prior to the hearing
(unless the ALJ grants additional time),
and that copies be submitted to the
parties sent notice of the hearing, to
help ensure the ALJ and the parties have
an opportunity to review the materials
prior to the hearing. Current § 405.1012
does not address the consequence of
failure to submit a position paper or
evidence in accordance with the
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43815
section. We are proposing in
§ 405.1012(c)(2)(iii) that a position
paper, written testimony, and/or
evidence would not be considered in
deciding an appeal if CMS or a
contractor fails to send a copy of its
position paper, written testimony, and/
or evidence to the parties or fails to
submit the position paper, written
testimony, and/or evidence within the
established time frames. This would
help ensure CMS or contractor position
papers and evidence are submitted
timely and shared with the parties.
As discussed above, current
§ 405.1012 does not limit the number
entities (that is, CMS and its
contractors) that may elect to be a party
to the hearing and, as also discussed
above, we are proposing to revise
§ 405.1010 and 405.1012 to limit the
number of entities that participate in a
hearing unless an ALJ determines that
an entity’s participation is necessary for
a full examination of the matters at
issue. We are proposing to revise
§ 405.1012(d)(1) to provide that if CMS
and one or more contractors, or multiple
contractors file elections to be a party to
a hearing, the first entity to file its
election after the notice of hearing is
issued is made a party to the hearing
and the other entities are made
participants in the proceedings under
§ 405.1010, subject to § 405.1010(d)(1)
and (3) (and as such may file position
papers and provide written testimony to
clarify factual or policy issues in the
case, but may not participate in the oral
hearing unless the ALJ grants leave to
the entity to participate in the oral
hearing in accordance with
§ 405.1010(d)(3)). Similar to proposed
§ 405.1010(d)(3), we are also proposing
in § 405.1012(d)(2) that,
notwithstanding the limitation in
proposed § 405.1012(d)(1), an ALJ may
grant leave for additional entities to be
parties to the hearing if the ALJ
determines that an entity’s participation
as a party is necessary for full
examination of the matters at issue.
We believe allowing the first entity to
file an election after a notice of hearing
is issued to be a party to the hearing is
administratively efficient and provides
an objective way to determine which
entity is made a party based on the
competing elections, while providing an
opportunity to participate in the appeal
by filing a position paper and/or written
testimony under § 405.1010 for those
that file later in time, or to be made a
participant or party to the hearing by the
ALJ under the ALJ’s discretionary
authority under proposed
§§ 405.1010(d)(3) and 405.1012(d)(2).
We considered an alternate proposal of
the first entity that had elected
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participant status under § 405.1010, if
any, being given priority for being made
a party to the hearing, but believe that
would result in other entities making a
party election being uncertain whether
they will be made a party to the hearing
until as few as 5 days prior to the
hearing (assuming the notice of hearing
is sent 20 days prior to the scheduled
hearing, as required by § 405.1022(a),
the QIC receives the notice of hearing 5
days later, and the entity or entities
responding to the notice of hearing can
make their election as late as 10
calendar days after the QIC’s receipt of
the notice, leaving only 5 days prior to
the hearing). We also considered a
process by which the ALJ would assess
which entity making a party election
would be most helpful to the ALJ at the
hearing, or in the alternative, permitting
all entities that filed a party election to
be made a party to the hearing unless
the ALJ determined an entity is not
necessary for the hearing, but both of
these approaches would add
administrative burden to the ALJ and
could result in CMS, contractors and
parties being uncertain of which entities
will be parties to the hearing until
shortly before the hearing. We welcome
comments on the alternatives
considered above.
Finally, we are proposing to add new
§ 405.1012(e) to address the possibility
of CMS or a contractor making an
invalid election. Proposed
§ 405.1012(e)(1) would provide that an
ALJ or attorney adjudicator may
determine an election is invalid if the
request for hearing was filed by an
unrepresented beneficiary, the election
was not timely, the election was not
sent to the correct parties, or CMS or a
contractor had already filed an election
to be a party to the hearing and the ALJ
did not determine that the entity’s
participation as a party is necessary for
a full examination of the matters at
issue. This would help ensure that CMS
and its contractors make timely
elections and inform parties of
elections, and also provide a mechanism
to address an election when the request
for hearing was filed by an
unrepresented beneficiary or when
another entity has already filed an
election to be a party to the hearing. To
provide notice to the entity and the
parties that an election was deemed
invalid, proposed § 405.1012(e)(2)
would require a written notice of an
invalid election be sent to the entity that
made the election and the parties who
were sent the notice of hearing. If the
election was submitted after the hearing
occurred, proposed § 405.1012(e)(2)(i)
would provide that the notice of an
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invalid election be sent no later than the
date the decision, dismissal, or remand
notice is mailed. If the election was
submitted before the hearing occurs,
proposed § 405.1012(e)(2)(ii) would
provide that the written notice of
invalid election is sent prior to the
hearing, and that if the notice would be
sent fewer than 5 calendar days before
the hearing is scheduled to occur, oral
notice would be provided to the entity
that submitted the election, and the
written notice to the entity and the
parties who were sent the notice of
hearing would be sent as soon as
possible after the oral notice is
provided.
We are inviting public comments on
these proposals. If you choose to
comment on the proposals in this
section, please include the caption
‘‘Section 405.1012: When CMS or its
contractors may be a party to a hearing’’
at the beginning of your comment.
g. Request for an ALJ Hearing or Review
of a QIC or IRE Dismissal (§§ 405.1014,
423.1972 and 423.2014)
Current §§ 405.1014 and 423.2014
explain the requirements for requesting
an ALJ hearing, including what must be
contained in the request, when and
where to file the request, the extension
of time to request a hearing, and in
§ 405.1014 to whom a copy of the
request for hearing must be sent. We are
proposing to restructure the sections,
clarify and provide additional
instructions, and address other matters
that have caused confusion for parties
and adjudicators.
i. Requirements for a Request for
Hearing or Review of a QIC or IRE
Dismissal
We are proposing to revise the title
and provisions of §§ 405.1014 and
423.2014 to more clearly cover a request
for a review of a QIC or IRE dismissal.
While the current requirements for
requesting an ALJ hearing are generally
used for requesting a review of a QIC or
IRE dismissal in form HHS–725, we
believe that explicitly extending
§§ 405.1014 and 423.2014 to cover
requests for these types of review would
provide clarity to parties and
adjudicators on the requirements for
requesting a review of a QIC or IRE
dismissal. As such, we are proposing in
the title to § 405.1014 and in subsection
(a)(1) (current subsection (a)) to add ‘‘or
a review of a QIC dismissal’’ after ‘‘ALJ
hearing,’’ and in subsection (c) (current
subsection (b)) to delete ‘‘after a QIC
reconsideration’’ and add ‘‘or request for
review of a QIC dismissal’’ after ‘‘an ALJ
hearing.’’ Similarly, we are proposing in
the title to § 423.2014 and in subsection
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(a)(1) (current subsection (a)) to add ‘‘or
a review of an IRE dismissal’’ after ‘‘ALJ
hearing,’’ and in subsection (d) (current
subsection (c)) to add ‘‘or request for
review of an IRE dismissal’’ after ‘‘IRE
reconsideration.’’
We are proposing in
§ 405.1014(a)(1)(i) through (a)(1)(vi) to
incorporate current § 405.1014(a)(1)
through (a)(6) with revisions. In
addition to the current requirements in
subsection (a)(1), we are proposing in
§ 405.1014(a)(1)(i) to require the
beneficiary’s telephone number if the
beneficiary is the filing party and is not
represented. This would help ensure
that OMHA is able to make timely
contact with the beneficiary to clarify
his or her filing, or other matters related
to the adjudication of his or her appeal,
including scheduling the hearing. We
are proposing in § 405.1014(a)(1)(ii) to
require the appellant’s telephone
number, along with the appellant’s
name and address as currently required
in subsection (a)(2), when the appellant
is not the beneficiary, and in
§ 405.1014(a)(1)(iii) to require a
representative’s telephone number,
along with the representative’s name
and address which is currently included
in subsection (a)(3), if a representative is
involved. Like the beneficiary telephone
number requirement, these
requirements would help ensure that
OMHA is able to make timely contact
with a non-beneficiary appellant and
any representative involved in the
appeal to clarify the filing or other
matters related to the adjudication of the
appeal, including scheduling the
hearing. Current subsection (a)(4) states
that the request must include the
document control number assigned to
the appeal by the QIC, if any. We are
proposing in § 405.1014(a)(1)(iv) to
require the Medicare appeal number or
document control number, if any,
assigned to the QIC reconsideration or
dismissal notice being appealed, to
reduce confusion for appellants. We are
proposing in § 405.1014(a)(1)(v) to add
language to the current language in
subsection (a)(5), so that instead of
requiring the ‘‘dates of service,’’ we
would require the ‘‘dates of service for
the claims being appealed, if
applicable,’’ because an appellant may
appeal some but not all of the partially
favorable or unfavorable claims in a QIC
reconsideration and a small number of
appeals do not involve a date of service
(for example, entitlement appeals). We
are proposing to incorporate the same
language in current subsection (a)(6)
into proposed subsection (a)(1)(vi).
We are proposing to add a new
requirement to the content of the
request in § 405.1014(a)(1)(vii) by
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requiring a statement of whether the
filing party is aware that it or the claim
is the subject of an investigation or
proceeding by the OIG or other law
enforcement agencies. This information
is necessary to assist OMHA staff in
checking whether the provider or
supplier was excluded from the program
on the date of service at issue prior to
scheduling a hearing or issuing a
decision, as well as for the ALJ to
determine whether to request the
participation of CMS or any program
integrity contractors that may have been
involved in reviewing the claims below.
However, we note that the information
is only required if the filing party is
aware of an investigation and
proceeding, and the information would
not be the basis for a credibility
determination on evidence or testimony,
as an investigation or allegations prior
to findings of wrongdoing by a court of
competent jurisdiction are not an
appropriate foundation for credibility
determinations in the context of part
405, subpart I administrative appeals.
As discussed in Section III.A.3.d
above, we are proposing changes to the
methodology for calculating the amount
in controversy required for an ALJ
hearing to better align the amount in
controversy with the actual amount in
dispute. We are also proposing new
§ 405.1014(a)(1)(viii) to require that
providers, suppliers, Medicaid State
agencies, applicable plans, and
beneficiaries represented by a provider,
supplier, or Medicaid State agency
include in their request for hearing the
amount in controversy applicable to the
disputed claim, as specified in
§ 405.1006(d), unless the matter
involves a provider or supplier
termination of Medicare-covered items
or services that is disputed by a
beneficiary, and the beneficiary did not
elect to continue receiving the items or
services. As we discussed in section
III.A.3.d., in instances where the
Medicare allowable amount would serve
as the basis for the amount in
controversy (which we believe would be
the majority of Part B appeals), we
believe providers, suppliers, and
Medicaid State agencies would be able
to utilize existing CMS tools and
resources to determine the allowable
amount used as the basis for the amount
in controversy under proposed
§ 405.1006(d)(2)(i)(A) and arrive at the
amount in controversy after deducting
any Medicare payments that have
already been made or awarded and any
deductible and/or coinsurance that may
be collected for the items and services
in the disputed claim. In addition, we
believe that providers, suppliers,
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applicable plans, and Medicaid State
agencies also would have access to the
billing, payment and other necessary
information to calculate the amount in
controversy under other provisions of
§ 405.1006(d). For scenarios where the
basis for the amount in controversy
would be calculated in accordance with
proposed § 405.1006(d)(2)(i)(B), (ii), (iii),
or where the amount in controversy
would be calculated in accordance with
§ 405.1006(d)(3), (5), (6), or (7), we
discuss in section III.A.3.d above how
appellants would determine the amount
in controversy in order to include it on
their request for hearing. However,
because we believe there may be
instances where a beneficiary who is not
represented by a provider, supplier, or
Medicaid State agency may not have the
information necessary to determine the
amount in controversy under
§ 405.1006(d) (as discussed above), we
are not proposing to require
beneficiaries who are not represented by
a provider, supplier, or Medicaid State
agency to include the amount in
controversy in their requests for hearing.
Furthermore, as noted above, we are not
proposing that any appellant include
the amount in controversy on requests
for hearing where the amount in
controversy would be calculated in
accordance with § 405.1006(d)(4) (for a
provider or supplier termination of
Medicare-covered items or services that
is disputed by a beneficiary, and the
beneficiary did not elect to continue
receiving the items or services). We
expect that, in this situation, a
beneficiary could easily determine
whether the minimum amount in
controversy required for an ALJ hearing
would be met through a conversation
with the provider or supplier, or from
the statement we are proposing the QIC
include in its notice of reconsideration
as discussed in section III.A.3.d above.
However, we believe the exact amount
in controversy could be difficult to
determine because it may depend on
unknown factors, such as the length of
continued services that may be required,
and so we are not requiring appellants
to include this amount in the request for
hearing.
Lastly, current § 405.1014(a)(7), which
requires a statement of any additional
evidence to be submitted and the date
it will be submitted, would be
separately designated in its entirety as
proposed § 405.1014(a)(2) because the
information in proposed
§ 405.1014(a)(1) must be present for a
request for hearing to be processed and
therefore would make the request
subject to dismissal if the information is
not provided, as discussed below. In
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contrast, the information in proposed
§ 405.1014(a)(2) is only necessary if
evidence would be submitted and
would not make the request subject to
dismissal if not present in the request.
Similar to proposed § 405.1014(a), we
are proposing at § 423.2014(a)(1)(i)
through (a)(1)(vi) to incorporate current
§ 423.2014(a)(1) through (a)(6) with
revisions. Current subsection (a)(3)
states that the request must include the
appeals case number assigned to the
appeal by the IRE, if any. We are
proposing in § 405.1014(a)(1)(iii) to
revise the requirement to state that the
request must include the Medicare
appeal number, if any, assigned to the
IRE reconsideration or dismissal being
appealed, to reflect the terminology
used by the IRE and thereby reduce
confusion for enrollees. Current
subsection (a)(6) states that the request
must include the reasons the enrollee
disagrees with the IRE’s reconsideration.
We are proposing to insert ‘‘or
dismissal’’ after ‘‘reconsideration’’ to
again reflect the terminology used by
the IRE and thereby reduce confusion
for enrollees. For the same reasons as
we proposed for § 405.1014(a)(1)(vii),
we are proposing at § 423.2014(a)(1)(vii)
to require a statement of whether the
enrollee is aware that he or she, or the
prescription for the drug being
appealed, is the subject of an
investigation or proceeding by the OIG
or other law enforcement agencies. In
addition, we are proposing at
§ 423.2014(a)(2) to incorporate the
current § 423.2014(a)(7) requirement to
include a statement of any additional
evidence to be submitted and the date
it will be submitted, and at
§ 423.2014(a)(3) to incorporate the
current § 423.2014(a)(8) requirement to
include a statement that the enrollee is
requesting an expedited hearing, if
applicable.
We are inviting public comments on
these proposals. If you choose to
comment on the proposals in this
section, please include the caption
‘‘Requirements for a request for hearing
or review of a QIC or IRE dismissal’’ at
the beginning of your comment.
ii. Requests for Hearing Involving
Statistical Sampling and Extrapolations
We are proposing to add new
§ 405.1014(a)(3) to address appeals in
which an appellant raises issues
regarding a statistical sampling
methodology and/or an extrapolation
that was used in making an
overpayment determination. OMHA has
encountered significant issues when an
appellant challenges aspects of a
statistical sampling methodology and/or
the results of extrapolations in separate
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appeals for each sampled claim
involved in the statistical sampling and/
or extrapolation. Appeals often need to
be reassigned to avoid multiple
adjudicators addressing the challenges
to the statistical sampling methodology
and/or extrapolation, and any
applicable adjudication time frames
attach to the individual appeals. Under
proposed § 405.1014(a)(3), if an
appellant is challenging the statistical
sampling methodology and/or
extrapolation, the appellant’s request for
hearing must include the information in
proposed § 405.1014(a)(1) and (a)(2) for
each sample claim that the appellant
wishes to appeal, be filed within 60
calendar days of the date that the party
received the last reconsideration for the
sample claims (if they were not all
addressed in a single reconsideration),
and assert the reasons the appellant
disagrees with the statistical sampling
methodology and/or extrapolation in the
request for hearing. We believe it would
be appropriate in this situation to allow
the appellant’s request for hearing to be
filed within 60 calendar days of the date
that the party received the last
reconsideration for the sample claims (if
they were not all addressed in a single
reconsideration), because if the
appellant also wishes to challenge the
statistical sampling methodology and/or
extrapolation, the appellant would wait
to file a request for hearing until all of
the QIC reconsiderations for the sample
units are received, which could be more
than 60 calendar days after the first
received QIC reconsideration of one of
the sample claims. We also state that the
60 calendar day period in proposed
§ 405.1014(a)(3)(ii) would begin on the
date the party receives the last
reconsideration of a sample claim,
regardless of the outcome of the claim
in the reconsideration or whether the
sample claim is appealed in the request
for hearing. We believe proposed
§ 405.1014(a)(3) would balance the
party’s rights to request a hearing on
individual claims when only the sample
claims are appealed, with the needs to
holistically address issues related to
statistical sampling methodologies and
extrapolations when those
determinations are also challenged. We
are not proposing any corresponding
changes to § 423.2014 because sampling
and extrapolation are not currently used
in Part D appeals.
We are inviting public comments on
these proposals. If you choose to
comment on the proposals in this
section, please include the caption
‘‘Requests for hearing involving
statistical sampling and extrapolations’’
at the beginning of your comment.
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iii. Opportunity To Cure Defective
Filings
There has been considerable
confusion on the implications of not
providing the information required by
current § 405.1014(a) in order to perfect
a request for hearing, and significant
time and resources have been spent on
this procedural matter by parties,
OMHA, and the Council. To provide
clearer standards and reduce confusion,
we are proposing in § 405.1014(b)(1)
that a request for hearing or request for
a review of a QIC dismissal must
contain the information specified in
proposed § 405.1014(a)(1) to the extent
the information is applicable, to be
complete, and § 405.1014(b)(1) would
provide that any applicable adjudication
time frame does not begin until the
request is complete because the
information is necessary to the
adjudication of the appeal. We are
proposing in § 405.1014(b)(1) to also
provide an appellant with an
opportunity to complete the request if
the request is not complete. However, if
the appellant fails to provide the
information necessary to complete the
request in the time frame provided, the
request would not be complete and
would be dismissed in accordance with
proposed § 405.1052(a)(7) or (b)(4). We
are also proposing at § 405.1014(b)(2) to
allow for consideration of supporting
materials submitted with a request
when determining whether the request
is complete, provided the necessary
information is clearly identifiable in the
materials, to provide that an appellant’s
request and supporting materials is
considered in its totality. For example,
if an appellant were to submit a request
for hearing and included a copy of the
QIC reconsideration, the Medicare
appeal number on the QIC
reconsideration would generally satisfy
the subsection (a)(1)(iv) requirement
because it clearly provides the
information. However, if there are
multiple claims in the QIC
reconsideration, the same document
possibly would not satisfy subsection
(a)(1)(v) because the appellant is not
required to appeal all partially favorable
or unfavorable claims, and subsection
(a)(1)(v) requires the appellant to
indicate the dates of service for the
claims that are being appealed.
Similarly, including medical records
only for the dates of service that the
appellant wishes to appeal would
generally not satisfy subsection (a)(1)(v)
because it would be unclear whether the
appellant intended to limit the appeal to
only those dates of service for which
medical records were included, or those
were the only dates of service for which
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the appellant had medical records. We
are proposing that the provisions of
proposed § 405.1014(b) be adopted in
proposed § 423.2014(c) for requesting an
ALJ hearing or a review of an IRE
dismissal in Part D appeals.
We are inviting public comments on
these proposals. If you choose to
comment on the proposals in this
section, please include the caption
‘‘Opportunity to cure defective filings’’
at the beginning of your comment.
iv. Where and When To File a Request
for Hearing or Review of a QIC or IRE
Dismissal
We are proposing to incorporate
portions of current § 405.1014(b) in
proposed § 405.1014(c) and portions of
current § 423.2014(c) in proposed
§ 423.2014(d) to address when and
where to file a request for hearing or
review. We are proposing in
§§ 405.1014(c) introductory language
and (c)(1), and 423.2014(d) introductory
language and (d)(1), to incorporate a
request for a review of a QIC dismissal
and a request for a review of an IRE
dismissal, respectively, and provide that
the current 60 calendar day period to
file a request for hearing after a party
receives a QIC or an IRE reconsideration
also applies after a party receives a QIC
or IRE dismissal, which is the time
frame stated in §§ 405.1004 and
423.2004 to request a review of a QIC or
IRE dismissal, respectively. We also are
proposing in § 405.1014(c)(1) to add an
exception for requests filed in
accordance with proposed
§ 405.1014(a)(3)(ii), because as
discussed above, we are proposing to
require that requests for hearing on
sample claims that are part of a
statistical sample and/or extrapolation
that the appellant also wishes to
challenge would be filed together,
which may be more than 60 calendar
days after the appellant receives the first
QIC reconsideration of one of the
sample claims. In addition, we are
proposing to revise the statement that a
request must be ‘‘submitted’’ in current
§ 423.2014(c)(1), with a request must be
‘‘filed’’ in § 423.2014(d)(1), for
consistency with § 405.1014 and
§ 422.602, both of which use the term
‘‘filed.’’ We are also proposing in
§§ 405.1014(c)(2) and 423.2014(d)(2) to
replace references to sending requests to
the ‘‘entity’’ specified in the QIC’s or
IRE’s reconsideration in current
§§ 405.1014(b)(2) and 423.2014(c)(2),
with sending requests to the ‘‘office’’
specified in the QIC’s or IRE’s
reconsideration or dismissal,
respectively, so they are properly
routed. As discussed in III.A.3.b. and
III.A.3.c, above, regarding proposed
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§§ 405.1002 and 405.1004, and 423.2002
and 423.2004, replacing ‘‘entity’’ with
‘‘office’’ in §§ 405.1014, 423.1972, and
423.2014 would help ensure appellants
are aware that a request for hearing or
request for a review of a QIC or IRE
dismissal must be filed with the office
indicated in the QIC’s or IRE’s
reconsideration or dismissal and avoid
delays. However, we again note that for
the few requests for hearing that are
misrouted by a party, a notice would be
sent to the appellant when the request
for hearing is received in the correct
office and the date the timely request
was received by the incorrect office
would be used to determine the
timeliness of the request, in accordance
with proposed §§ 405.1014(c)(2) and
423.2014(d)(2)(i), which would
incorporate the misrouted request
provisions from current
§§ 405.1014(b)(2) and 423.2014(c)(2)(i).
We are also proposing in
§§ 405.1014(c)(2) and 423.2014(d)(2)(i)
that the adjudication time frame is only
affected if there is an applicable
adjudication time frame for the appeal.
Current § 423.1972(b) states that an
enrollee must file a request for a hearing
within 60 calendar days of the date of
the notice of the IRE reconsideration
determination. This requirement differs
from § 423.2002(a)(1), which states that
a request for hearing must be filed
within 60 calendar days after receipt of
the IRE’s reconsideration (this is also
the standard for filing Part A and Part
B requests for hearing after receipt of
QIC reconsiderations, at
§ 405.1002(a)(1). We are proposing to
revise § 423.1972(b)(1) to state that a
request for hearing must be filed within
60 calendar days after receipt of the
IRE’s reconsideration. We also are
proposing to add new § 423.1972(b)(2),
to incorporate current § 423.2002(d),
which provides the date of receipt of the
reconsideration is presumed to be 5
calendar days after the date of the
written reconsideration unless there is
evidence to the contrary (this is also a
presumption for receipt of QIC
reconsiderations in Part A and Part B
appeals, at § 405.1002). These changes
would align proposed § 423.1972(b)
with current § 423.2002, and remove
potential enrollee confusion on when a
request for an ALJ hearing must be filed.
We are inviting public comments on
these proposals. If you choose to
comment on the proposals in this
section, please include the caption
‘‘Where and when to file a request for
hearing or review of a QIC or IRE
dismissal’’ at the beginning of your
comment.
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v. Sending Copies of a Request for
Hearing and Other Evidence to Other
Parties to the Appeal
We are proposing to incorporate the
portion of current § 405.1014(b)(2) that
states that the appellant must also send
a copy of the request for hearing to the
other parties and failure to do so will
toll the ALJ’s 90 calendar day
adjudication deadline until all parties to
the QIC reconsideration receive notice
of the requested ALJ hearing in
proposed § 405.1014(d) with changes
discussed below. Current
§ 405.1014(b)(2) has been another source
of considerable confusion, and
significant time and resources have been
spent on this procedural matter by
parties, OMHA, and the Council.
Current § 405.1014(b)(2) requires an
appellant to send a copy of the request
for hearing to the other parties. Other
parties consist of all of the parties
specified in § 405.906(b) as parties to
the reconsideration, including
beneficiaries in overpayment cases that
involve multiple beneficiaries who have
no liability, in which case the QIC may
elect to only send a notice of
reconsideration to the appellant, in
accordance with § 405.976(a)(2). We are
proposing in § 405.1014(d)(1) to amend
the current copy requirement by only
requiring an appellant to send a copy of
a request for an ALJ hearing or review
of a QIC dismissal to the other parties
who were sent a copy of the QIC’s
reconsideration or dismissal. This
change would make the standard
consistent with requests for Council
review, a copy of which must be sent by
the appellant to the other parties who
received a copy of an ALJ’s decision or
dismissal, in accordance with current
§ 405.1106(a). This change would also
extend the requirement to requests for
review of a QIC dismissal to provide the
other parties who received notice of the
QIC’s dismissal action with notice of the
appellant’s appeal of that action.
We are also proposing in
§ 405.1014(d)(1) to address whether
copies of materials that an appellant
submits with a request for hearing or
request for review of a QIC dismissal
must be sent to other parties. Currently
some ALJs consider the materials to be
part of the request and require an
appellant to send copies of all materials
submitted with a request, while other
ALJs do not consider the materials to be
part of the request. We are proposing in
§ 405.1014(d)(1) that if additional
materials submitted with a request are
necessary to provide the information
required for a complete request in
accordance with proposed
§ 405.1014(b), copies of the materials
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must be sent to the parties as well
(subject to authorities that apply to
disclosing the personal information of
other parties). If additional evidence is
submitted with the request for hearing,
the appellant may send a copy of the
evidence or briefly describe the
evidence pertinent to the party and offer
to provide copies of the evidence to the
party at the party’s request (subject to
authorities that apply to disclosing the
evidence). For example, if a complete
request includes a position paper or
brief that explains the reasons the
appellant disagrees with the QIC’s
reconsideration, in accordance with
proposed § 405.1014(a)(1)(v), a copy of
the position paper or brief would be
sent to the other parties, subject to any
authorities that apply to disclosing the
personal information of other parties.
However, additional evidence such as
medical records, is generally not
required for a complete request, and
therefore copies would not have to be
sent, but could instead be summarized
and provided to the other parties at their
request, again subject to any authorities
that apply to disclosing the personal
information of other parties. This
approach would balance the objectives
of ensuring that parties to a claim and
an appeal of that claim remain informed
of the proceedings that are occurring on
the claim, with the burdens on
appellants to keep their co-parties so
informed. We also note that in sending
a copy of the request for hearing and
associated materials, appellants are free
to include cover letters to explain the
request, but we note that such letters on
their own do not satisfy the copy
requirement in its current or proposed
form. No corresponding changes are
proposed in § 423.2014 because the
enrollee is the only party to the appeal.
Current § 405.1014 does not contain
standards for what constitutes evidence
that a copy of the request for hearing or
review, or copy of the evidence or a
summary thereof, was sent to the other
parties, which has led to confusion and
inconsistent practices. Therefore, we are
proposing in § 405.1014(d)(2) to address
this issue by establishing standards that
an appellant would follow to satisfy the
requirement. We are proposing in
§ 405.1014(d)(2) that evidence that a
copy of the request for hearing or
review, or a copy of submitted evidence
or a summary thereof, was sent
includes: (1) Certifications that a copy of
the request for hearing or request for
review of a QIC dismissal is being sent
to the other parties on the standard form
for requesting a hearing or review of a
QIC dismissal; (2) an indication, such as
a copy or ‘‘cc’’ line on a request for
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hearing or review, that a copy of the
request and any applicable attachments
or enclosures are being sent to the other
parties, including the name and address
of the recipients; (3) an affidavit or
certificate of service that identifies the
name and address of the recipient and
what was sent to the recipient; or (4) a
mailing or shipping receipt that
identifies the name and address of the
recipient and what was sent to the
recipient. We believe these options
would provide an appellant with
flexibility to document the copy
requirement was satisfied and bring
consistency to the process.
Beyond stating that an adjudication
time frame is tolled if a party does not
satisfy the copy requirement, current
§ 405.1014 does not address the
consequence of not satisfying the
requirement, and adjudicators are faced
with an appeal being indefinitely tolled
because an appellant refuses to comply
with the requirement. OMHA ALJs have
addressed this issue by providing
appellants with an opportunity to send
the required copy of the request for
hearing, and by informing the appellant
that if the copy is not sent, its request
will be dismissed. This allows OMHA
ALJs to remove requests that do not
satisfy the requirement from their active
dockets so time and resources can be
focused on appeals of those who comply
with the rules. We are proposing in
§ 405.1014(d)(3) that, if the appellant
fails to send a copy of the request for
hearing or request for review of a QIC
dismissal, any additional materials, or a
copy of the submitted evidence or a
summary thereof, the appellant would
be provided with an opportunity to cure
the defects by sending the request,
materials, and/or evidence or summary
thereof described in proposed
subsection (d)(1). Further, proposed
§ 405.1014(d)(3) would provide that if
an adjudication time frame applies, it
does not begin until evidence that the
request, materials, and/or evidence or
summary thereof were sent is received.
We are also proposing in
§ 405.1014(d)(3) that if an appellant
does not provide evidence within the
time frame provided to demonstrate that
the request, materials, and/or evidence
or summary thereof were sent to other
parties, the appellant’s request for
hearing or review would be dismissed.
We are inviting public comments on
these proposals. If you choose to
comment on the proposals in this
section, please include the caption
‘‘Sending copies of a request for hearing
and other evidence to other parties to
the appeal’’ at the beginning of your
comment.
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vi. Extending Time To File a Request for
Hearing or Review of a QIC or IRE
Dismissal
We are proposing that the provisions
of current §§ 405.1014(c) and
423.2014(d) for extensions of time to file
a request for hearing would be
incorporated in proposed §§ 405.1014(e)
and 423.2014(e) with changes, and
would extend to requests for reviews of
QIC and IRE dismissals. On occasion,
OMHA is asked whether a request for an
extension should be filed without a
request for hearing, for a determination
on the request for extension before the
request for hearing is filed. In those
instances, we ask the filer to file both
the request for hearing and request for
extension at the same time because an
independent adjudication of the
extension request would be inefficient
and any adjudication time frame begins
on the date that the ALJ grants the
extension request, in accordance with
current §§ 405.1014(c)(4) and
423.2014(d)(4). We are proposing in
§§ 405.1014(e)(2) and 423.2014(e)(3) to
require a request for an extension be
filed with the request for hearing or
request for review of a QIC or IRE
dismissal, with the office specified in
the notice of reconsideration or
dismissal. Proposed §§ 405.1014(e)(2)
and 423.2014(e)(3) would also align the
provision with proposed §§ 405.1014(c)
and 423.2014(d) by specifying that a
request for an extension must be filed
with the ‘‘office,’’ rather than the
‘‘entity,’’ specified in the notice of
reconsideration. We are proposing in
§ 405.1014(e)(3) and 423.2014(e)(4) that
an ALJ or attorney adjudicator may find
good cause to extend the deadline to file
a request for an ALJ hearing or a request
for a review of a QIC or IRE dismissal,
or there is no good cause for missing the
deadline to file a request for a review of
a QIC or IRE dismissal, but only an ALJ
may find there is no good cause for
missing the deadline to file a request for
an ALJ hearing. Because only an ALJ
may dismiss a request for an ALJ
hearing for an untimely filing in
accordance with proposed §§ 405.1052
and 423.2052, an attorney adjudicator
could not make a determination on a
request for an extension that would
result in a dismissal of a request for
hearing. We are also proposing to
incorporate current §§ 405.1014(c)(4)
and 423.2014(d)(5) into proposed
§§ 405.1014(e)(4) and 423.2014(e)(5),
but indicate that the adjudication time
frame begins on the date the ALJ or
attorney adjudicator grants the request
to extend the filing deadline only if
there is an applicable adjudication
period. Finally, we are proposing in
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§§ 405.1014(e)(5) and 423.2014(e)(6) to
add a new provision to provide finality
for the appellant with regard to a
determination to grant an extension of
the filing deadline. We are proposing
that if an ALJ or attorney adjudicator
were to make a determination to grant
the extension, the determination is not
subject to further review. However, we
are not precluding review of a
determination to deny an extension
because such a denial would result in a
dismissal for an untimely filing, and the
dismissal and determination on the
request for an extension would be
subject to review by the Council.
We are inviting public comments on
these proposals. If you choose to
comment on the proposals in this
section, please include the caption
‘‘Extending time to file a request for
hearing or review of a QIC or IRE
dismissal’’ at the beginning of your
comment.
h. Time Frames for Deciding an Appeal
of a QIC or IRE Reconsideration or an
Escalated Request for a QIC
Reconsideration, and Request for
Council Review When an ALJ Does Not
Issue a Decision Timely (§§ 405.1016,
405.1104 and 423.2016)
i. Section 405.1016: Time frames for
Deciding an Appeal of a QIC or an
Escalated Request for a QIC
Reconsideration
Current § 405.1016 addresses the
adjudication time frames for requests for
hearing filed after a QIC has issued its
reconsideration, in accordance with
section 1869(d)(1)(A) of the Act, and
escalations of requests for a QIC
reconsideration when the QIC does not
issue its reconsideration within its
adjudication time frame, which is
permitted by section 1869(c)(3)(C)(ii) of
the Act. We are proposing to revise the
title of § 405.1016 from ‘‘Time frames
for deciding an appeal before an ALJ’’ to
‘‘Time frames for deciding an appeal of
a QIC reconsideration or escalated
request for a QIC reconsideration’’
because the section specifically applies
to appeals of QIC reconsiderations and
escalated requests for QIC
reconsiderations (as specified in current
and proposed § 405.1016(a) and (c)).
This revision would also allow for
application of this section to requests
for hearing adjudicated by attorney
adjudicators, as proposed in Section
II.B. above. We also are proposing to
replace each instance of the term ‘‘the
ALJ’’ with ‘‘the ALJ or attorney
adjudicator’’ throughout proposed
§ 405.1016 to assist appellants in
understanding that an adjudication time
frame, and the option to escalate, also
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would apply to a request for an ALJ
hearing following a QIC reconsideration
when the request has been assigned to
an attorney adjudicator, as proposed in
section II.B, above. We are not
proposing to change the reference to ‘‘a
request for an ALJ hearing’’ because, as
explained above in section II.B, even if
an appellant waives its right to hearing,
the case would remain subject to a
potential oral hearing before an ALJ, and
we believe the request is therefore
properly characterized as a request for
an ALJ hearing.
We are proposing to add titles to
proposed § 405.1016(a) to indicate that
this paragraph discusses the
adjudication period for appeals of QIC
reconsiderations, and proposed
§ 405.1016(c) to indicate that this
paragraph discusses the adjudication
period for escalated requests for QIC
reconsiderations. In addition, proposed
§ 405.1016(a) and (c) would remove
‘‘must,’’ in providing that when a
request for an ALJ hearing is filed after
a QIC has issued a reconsideration, an
ALJ or attorney adjudicator issues a
decision, dismissal order, or remand to
the QIC, as appropriate, no later than
the end of the 90 calendar day period
beginning on the date the request for
hearing is received by the office
specified in the QIC’s notice of
reconsideration. While the statute
envisions that appeals will be
adjudicated within the statutory time
frame, the statute also provides for
instances in which the adjudication
time frame is not met by allowing an
appellant to escalate his or her appeal
to the next level of appeal. We believe
‘‘must’’ should be reserved for absolute
requirements, and in the context of
adjudication time frames, the statute
provides the option for an appellant to
escalate an appeal if the adjudication
time frame is not met.
We are proposing to add a title to
proposed § 405.1016(b) to indicate that
the paragraph discusses when an
adjudication period begins. Current
§ 405.1016(b), which explains that the
adjudication period for an appeal of a
QIC reconsideration begins on the date
that a timely filed request for hearing is
received unless otherwise specified in
the subpart, would be re-designated as
proposed § 405.1016(b)(1). We are
proposing in § 405.1016(b)(2) that if the
Council remands a case and the case
was subject to an adjudication time
frame under paragraph (a) or (c), the
remanded appeal would be subject to
the adjudication time frame of
§ 405.1016(a) beginning on the date that
OMHA receives the Council remand.
Currently the regulations do not address
whether an adjudication time frame
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applies to appeals that are remanded
from the Council, and whether
escalation is an option for these appeals.
To provide appellants with an
adjudication time frame for remanded
appeals that were subject to an
adjudication time frame when they were
originally appealed to OMHA, proposed
§ 405.1016(b)(2) would apply the
adjudication time frame under
§ 405.1016(a) to a remanded appeal that
was subject to an adjudication time
frame under paragraph (a) or (c). For
example, if an ALJ decision reviewed by
the Council involved a QIC
reconsideration and was remanded by
the Council, a 90 calendar day time
frame would apply from the date that
OMHA received the remand order. If the
adjudication time frame is not met
under proposed § 405.1016(b)(2), the
appeal would be subject to escalation, in
accordance with proposed
§ 405.1016(e).
In addition, we are proposing in
§ 405.1016(a) and (b) to align the
paragraphs with proposed § 405.1014(c)
by specifying that a request for hearing
is received by the ‘‘office,’’ rather than
the ‘‘entity,’’ specified in the QIC’s
notice of reconsideration.
We are proposing to add a title to
proposed § 405.1016(d) to indicate that
the paragraph discusses waivers and
extensions of the adjudication period.
We are proposing in § 405.1016(d)(1) to
incorporate the adjudication period
waiver provision in current
§ 405.1036(d), which states that, at any
time during the hearing process, the
appellant may waive the adjudication
deadline specified in § 405.1016 for
issuing a hearing decision, and that the
waiver may be for a specific period of
time agreed upon by the ALJ and the
appellant. We are proposing to move the
provision because we believe it is more
appropriately addressed in § 405.1016,
as it is directly related to the
adjudication period. Proposed
§ 405.1016(d) would also revise the
language in current § 405.1036(d) to
reference an attorney adjudicator
consistent with our proposals in Section
II.B. above; to reference the
‘‘adjudication’’ process rather than the
‘‘hearing process’’ to account for appeals
that may not involve a hearing, to
consistently reference an adjudication
‘‘period’’ for internal consistency, and to
replace the reference to § 405.1016 with
internal paragraph references.
Current § 405.1016 does not address
delays that result from stays ordered by
U.S. Courts. In addition, we have had
instances in which an appellant
requests a stay of action on his or her
appeals while related matters are
addressed by another court or tribunal,
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or by investigators. To address these
circumstances, we are proposing in
§ 405.1016(d)(2) that the adjudication
periods specified in paragraphs (a) and
(c) are extended as otherwise specified
in this subpart, and for the duration of
any stay of action on adjudicating the
claims or matters at issue ordered by a
court or tribunal of competent
jurisdiction, or the duration of any stay
of proceedings granted by an ALJ or
attorney adjudicator on the motion of
the appellant, provided no other party
also filed a request for hearing on the
same claim at issue.
We are inviting public comments on
these proposals. If you choose to
comment on the proposals in this
section, please include the caption
‘‘Section 405.1016: Time frames for
deciding an appeal of a QIC or an
escalated request for a QIC
reconsideration’’ at the beginning of
your comment.
ii. Incorporation of the Provisions of
Section 405.1104 (Request for Council
Review When an ALJ Does Not Issue a
Decision Timely) Into Section
405.1016(f)
Current § 405.1104 addresses how to
request escalation from an ALJ to the
Council, when an ALJ has not issued a
decision, dismissal or remand on a QIC
reconsideration within an applicable
adjudication time frame, in accordance
with section 1869(d)(3)(A) of the Act in
paragraph (a); the procedures for
escalating an appeal in paragraph (b);
and the status of an appeal for which
the adjudication time frame has expired
but the appellant has not requested
escalation in paragraph (c). We are
proposing to remove and reserve
§ 405.1104 and incorporate the current
§ 405.1104 providing for escalating a
request for an ALJ hearing to the
Council into proposed § 405.1016(e) and
(f) with revisions, as its current
placement in the Council portion of part
405, subpart I has caused confusion. We
also are proposing to insert ‘‘or attorney
adjudicator’’ after ‘‘ALJ’’ in proposed
§ 405.1016(e) and (f) to assist appellants
in understanding that the effect of
exceeding the adjudication period and
the option to escalate would apply to a
request for an ALJ hearing following a
QIC reconsideration when the request
has been assigned to an attorney
adjudicator, as discussed in section II.B,
above.
Current § 405.1104(c) is titled ‘‘No
escalation’’ and states that if the ALJ’s
adjudication period set forth in
§ 405.1016 expires, the case remains
pending with the ALJ until a decision,
dismissal order, or remand order is
issued or the appellant requests
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escalation to the Council. We are
proposing in § 405.1016(e) to
incorporate current § 405.1104(c) with
changes. We are proposing to revise the
paragraph title for proposed
§ 405.1016(e) to indicate that the
paragraph discusses the effect of
exceeding the adjudication period.
Proposed § 405.1016(e) would provide
that if an ALJ or an attorney adjudicator
assigned to a request for hearing (as
proposed in section II.B above) does not
issue a decision, dismissal order, or
remand to the QIC within an
adjudication period specified in the
section, the party that filed the request
for hearing may escalate the appeal
when the adjudication period expires.
However, if the adjudication period
expires and the party that filed the
request for hearing does not exercise the
option to escalate the appeal, the appeal
remains pending with OMHA for a
decision, dismissal order, or remand.
We are proposing to indicate that the
appeal remains pending with OMHA to
be inclusive of situations in which the
appeal is assigned to an ALJ or attorney
adjudicator, or not yet assigned.
Current § 405.1104(a) describes how
to request an escalation and states that
an appellant who files a timely request
for hearing before an ALJ and whose
appeal continues to be pending before
the ALJ at the end of the applicable ALJ
adjudication period may request
Council review if the appellant files a
written request with the ALJ to escalate
the appeal to the Council after the
adjudication period has expired, and the
ALJ does not issue a decision, dismissal
order, or remand order within the later
of 5 calendar days of receiving the
request for escalation or 5 calendar days
from the end of the applicable
adjudication period set forth in
§ 405.1016. We are proposing in
§ 405.1016(f)(1) to remove the
requirement to request Council review
in the course of requesting an escalation
and to describe when and how to
request escalation. Specifically, we are
proposing to revise the current
procedures at § 405.1104(a) and (a)(1), to
provide that an appellant who files a
timely request for a hearing with OMHA
and whose appeal continues to be
pending at the end of an applicable
adjudication period may exercise the
option to escalate the appeal to the
Council by filing a written request with
OMHA to escalate the appeal to the
Council, which would simplify the
process for appellants and adjudicators
by only requiring appellants to file a
single request for escalation with
OMHA. We are proposing to replace the
reference to an appeal that ‘‘continues to
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be pending before the ALJ’’ in current
§ 405.1104(a) with an appeal that
‘‘continues to be pending with OMHA’’
in proposed § 405.1016(f)(1) to be
inclusive of situations in which the
appeal is assigned to an ALJ or attorney
adjudicator, or not yet assigned. We are
also proposing that a written request to
escalate an appeal to the Council would
be filed with OMHA to allow OMHA to
provide a central filing option for
escalation requests. Current
§ 405.1106(b) requires that the appellant
send a copy of the escalation request to
the other parties and failing to do so
tolls the Council’s adjudication deadline
set forth in § 405.1100 until the other
parties to the hearing have received
notice. As discussed in section III.A.5.c
below, we are proposing to revise
§ 405.1106(b) to require that the request
for escalation be sent to other parties
who were sent a copy of the QIC
reconsideration. Therefore, we are also
proposing at § 405.1016(f)(1) that the
appellant would send a copy of the
escalation request to the other parties
who were sent a copy of the QIC
reconsideration so appellants would be
aware of the requirement and which
parties must be sent a copy of the
escalation request.
Current § 405.1104(b) describes the
escalation process and states if the ALJ
is not able to issue a decision, dismissal
order, or remand order within the time
period set for in paragraph (a)(2) of the
section (later of 5 calendar days of
receiving the request for escalation or 5
calendar days from the end of the
applicable adjudication period set forth
in § 405.1016), he or she sends notice to
the appellant acknowledging receipt of
the request for escalation and
confirming that the ALJ is not able to
issue a decision, dismissal order, or
remand order within the statutory time
frame, or if the ALJ does not act on a
request for escalation within the time
period set forth in paragraph (a)(2) of
the section or does not send the
required notice to the appellant, the QIC
decision becomes the decision that is
subject to Council review consistent
with § 405.1102(a). This process has
caused confusion for both appellants
and adjudicators because an initial
escalation request must be filed with the
ALJ, and if the ALJ is unable to issue a
decision, dismissal or remand within 5
calendar days of receiving the escalation
request or within 5 calendar days from
the end of the applicable adjudication
period, the appellant must file a request
for Council review to move the appeal
to the Council level, which some
appellants do not file. This leaves it
unclear to the ALJ and support staff
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whether to continue adjudicating the
appeal after issuing a notice that the ALJ
is unable to issue a decision, dismissal
or remand within 5 calendar days of
receiving the escalation request. We are
proposing in § 405.1016(f)(2) to revise
the escalation process. Specifically, we
are proposing that if an escalation
request meets the requirements of
proposed § 405.1016(f)(1), and an ALJ or
attorney adjudicator is not able to issue
a decision, dismissal order, or remand
within the later of 5 calendar days of
receiving the request for escalation or 5
calendar days from the end of the
applicable adjudication period, OMHA
(to be inclusive of situations in which
the appeal is assigned to an ALJ or
attorney adjudicator, or not yet
assigned) would send a notice to the
appellant stating that an ALJ or attorney
adjudicator is not able to issue a
decision, dismissal order, or remand
order within the adjudication period set
forth in paragraph (a) or (c) of
§ 405.1016. We also are proposing that
the notice would state that the QIC
reconsideration would be the decision
that is subject to Council review
consistent with § 405.1102(a); and the
appeal would be escalated to the
Council in accordance with § 405.1108.
OMHA would then forward the case
file, which would include the file
received from the QIC and the request
for escalation and all other materials
filed with OMHA, to the Council. We
believe that this proposed process
would help alleviate the current
confusion, and would simplify the
escalation process for appellants
because appellants would not have to
file a separate request for Council
review after filing an escalation request
with OMHA.
Currently, invalid escalation requests
are not addressed in the regulations. We
are proposing in § 405.1016(f)(3) to
address invalid escalation requests. We
are proposing that if an ALJ or attorney
adjudicator determines an escalation
request does not meet the requirements
of proposed § 405.1016(f)(1), OMHA
would send a notice to the appellant
explaining why the request is invalid
within 5 calendar days of receiving the
request for escalation. For example, an
escalation request would be deemed
invalid if escalation is not available for
the appeal, such as appeals of SSA
reconsiderations; the escalation request
is premature because the adjudication
period has not expired; or the party that
filed the escalation request did not file
the request for hearing. If an ALJ or
attorney adjudicator were to determine
the request for escalation was invalid for
a reason that could be corrected (for
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example, if the request was premature),
the appellant could file a new escalation
request when the adjudication period
expires.
We are inviting public comments on
these proposals. If you choose to
comment on the proposals in this
section, please include the caption
‘‘Section 405.1016: Escalation of a
request for an ALJ hearing’’ at the
beginning of your comment.
iii. Section 423.2016: Time frames for
Deciding an Appeal of an IRE
Reconsideration
Current § 423.2016 addresses the
adjudication time frames for requests for
hearing filed after an IRE has issued its
reconsideration. The title of current
§ 423.2016 states, ‘‘Timeframes for
deciding an Appeal before an ALJ.’’ We
are proposing to revise the title of
§ 423.2016 to read ‘‘Time frames for
deciding an appeal of an IRE
reconsideration’’ in order to state that
the section addresses adjudication time
frames related to appeals of IRE
reconsiderations and to accommodate
the application of this section to
attorney adjudicators, as proposed in
Section II.B. above, and as discussed
earlier. We also are proposing to insert
‘‘or attorney adjudicator’’ after ‘‘ALJ’’
throughout proposed § 423.2016 so that
an adjudication time frame would apply
to a request for an ALJ hearing following
an IRE reconsideration when the request
has been assigned to an attorney
adjudicator, as discussed in section II.B,
above.
Current § 423.2016(a) and (b) explain
the adjudication time frames for
standard and expedited appeals of IRE
reconsiderations, respectively. However,
the current paragraph titles refer to
hearings and expedited hearings. We are
proposing at § 423.2016(a) and (b) to
retitle the paragraphs to refer to
standard appeals and expedited appeals
because the time frames apply to issuing
a decision, dismissal, or remand, and
are not limited to appeals in which a
hearing is conducted. Similar to
proposed § 405.1016, we are proposing
at § 423.2016(a) and (b) to remove
‘‘must’’ in providing when an ALJ or
attorney adjudicator issues a decision,
dismissal order, or remand to the IRE,
as appropriate, after the request for
hearing is received by the office
specified in the IRE’s notice of
reconsideration because there may be
instances in which a decision,
dismissal, or remand cannot be issued
within the adjudication time frame,
though we expect those instances to be
rare because beneficiary and enrollee
appeals are generally prioritized by
OMHA. In addition, we are proposing in
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§ 423.2016(a) and (b) to replace
references to sending a request to the
‘‘entity’’ specified in the IRE’s
reconsideration, with the ‘‘office’’
specified in the IRE’s reconsideration
notice, to minimize confusion and
delays in filing requests with OMHA.
Similar to proposed § 405.1016(b)(2), we
are proposing at § 423.2016(a)(3) and
(b)(6) to adopt adjudication time frames
for appeals that are remanded by the
Council. Specifically, we are proposing
in § 423.2016(a)(3) that if the Council
remands a case and the case was subject
to an adjudication time frame, the
remanded appeal would be subject to
the same adjudication time frame
beginning on the date that OMHA
receives the Council remand to provide
enrollees with an adjudication time
frame for remanded appeals. In
§ 423.2016(b)(6), we are proposing to
require that if the standards for an
expedited appeal continue to be met
after the appeal is remanded from the
Council, the 10-day expedited time
frame would apply to an appeal
remanded by the Council. If the
standards for an expedited appeal are no
longer met, the adjudication time frame
for standard appeals would apply
because the criteria for an expedited
hearing are no longer present. Finally,
we are proposing at § 423.2016(b) to
revise the expedited appeal request
process to permit an ALJ or attorney
adjudicator to review a request for an
expedited hearing, but not require the
same ALJ or attorney adjudicator to
adjudicate the expedited appeal, to
provide OMHA with greater flexibility
to review and assign requests for
expedited hearings, and help ensure the
10-day adjudication process is
completed as quickly as the enrollee’s
health requires. For example, if an
attorney adjudicator were to review a
request for an expedited hearing and
determine that the standards for an
expedited hearing were met, but did not
believe a decision could be issued
without a hearing, the attorney
adjudicator could provide the enrollee
with notice that the appeal would be
expedited and transfer the appeal to an
ALJ for an expedited hearing and
decision.
As described in section III.A.3.q
below, we are proposing to move the
provision for waiving the adjudication
period from current § 423.2036(d) to
proposed § 423.2016(c) because
proposed § 423.2016 addresses
adjudication time frames and we believe
the section is a better place for
discussing adjudication time frame
waivers.
We are proposing that the provisions
of proposed § 405.1016(d) be adopted in
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proposed § 423.2016(c) for adjudication
period waivers and stays of the
proceedings ordered by a court or
granted by an ALJ or attorney
adjudicator on motion by an enrollee.
We are inviting public comments on
these proposals. If you choose to
comment on the proposals in this
section, please include the caption
‘‘Section 423.2016: Time frames for
deciding an appeal of an IRE
reconsideration’’ at the beginning of
your comment.
i. Submitting Evidence (§§ 405.1018 and
423.2018)
Current §§ 405.1018 and 423.2018
address submitting evidence before an
ALJ hearing is conducted. We are
proposing to retitle the sections from
‘‘Submitting evidence before the ALJ
hearing’’ to ‘‘Submitting evidence’’
because evidence may be submitted and
considered in appeals for which no
hearing is conducted by an ALJ, and we
believe an attorney adjudicator should
be able to consider submitted evidence
in deciding appeals as proposed in
section II.B above. For the same reason,
we are proposing in § 423.2018 to
replace the references to ‘‘hearings’’ in
the heading to paragraph (a) and in the
introductory text to paragraphs (b) and
(c), with ‘‘appeals.’’ We are also
proposing to add headings to paragraphs
that do not currently have headings, for
clarity of the matters addressed in the
paragraphs.
Current § 405.1018(a) states that,
except as provided in this section,
parties must submit all written evidence
they wish to have considered at the
hearing with the request for hearing (or
within 10 calendar days of receiving the
notice of hearing). We are proposing in
§ 405.1018(a) to provide for the
submission of other evidence, in
addition to written evidence, that the
parties wish to have considered. Other
evidence could be images or data
submitted on electronic media. This
revision would also be adopted in
proposed § 405.1018(b) and
§ 423.2018(a), (b), and (c). We are also
proposing in § 405.1018(a) to remove ‘‘at
the hearing’’ so that parties would
submit all written or other evidence
they wish to have considered, and
consideration of the evidence would not
be limited to the hearing. We are
proposing a corresponding change at
proposed § 423.2018(a).
Current § 405.1018(a) states that
evidence must be submitted with the
request for hearing, or within 10
calendar days of receiving the notice of
hearing. This provision has caused
confusion as to when evidence is
required to have been submitted
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because current § 405.1014(a)(7) allows
an appellant to state in the request for
hearing that additional evidence will be
submitted and the date it will be
submitted. To reconcile the provisions,
we are proposing in § 405.1018(a) to
provide that parties must submit all
written or other evidence they wish to
have considered with the request for
hearing, by the date specified in the
request for hearing in accordance with
proposed § 405.1014(a)(2), or if a
hearing is scheduled, within 10
calendar days of receiving the notice of
hearing. We also are proposing that
these revisions would be adopted in
proposed § 423.2018(b) and (c).
Current § 405.1018(b) addresses how
the submission of evidence impacts the
adjudication period, and provides that if
evidence is submitted later than 10
calendar days after receiving the notice
of hearing, the period between when the
evidence ‘‘was required to have been
submitted’’ and the time it is received
does not count towards an adjudication
period. To simplify the provision, we
are proposing at § 405.1018(b) that if
evidence is submitted later than 10
calendar days after receiving the notice
of hearing, any applicable adjudication
period is extended by the number of
calendar days in the period between 10
calendar days after receipt of the notice
of hearing and the day the evidence is
received. This revision would also be
adopted in proposed § 423.2018(b)(2)
and (c)(2), except that in (c)(2), the
adjudication time frame is affected if the
evidence is submitted later than 2
calendar days after receipt of the notice
of expedited hearing because 2 calendar
days is the equivalent time frame to
submit evidence for expedited appeals
before the adjudication period is
affected under current § 423.2018.
Current § 405.1018(c) addresses new
evidence, and is part of the
implementation of section 1869(b)(3) of
the Act, which precludes a provider or
supplier from introducing evidence after
the QIC reconsideration unless there is
good cause that prevented the evidence
from being introduced at or before the
QIC’s reconsideration. These provisions,
which provide for the early submission
of evidence, allow adjudicators to obtain
evidence necessary to reach the correct
decision as early in the appeals process
as possible. We are proposing to
incorporate current § 405.1018(c), which
requires a provider, supplier, or
beneficiary represented by a provider or
supplier that wishes to introduce new
evidence to submit a statement
explaining why the evidence was not
previously submitted to the QIC, or a
prior decision-maker, in proposed
§ 405.1018(c)(1). However, current
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§ 405.1018 does not address the
consequences of not submitting the
statement. The statute sets a bar to
introducing new evidence, and the
submitting party must establish good
cause by explaining why the evidence
was not previously submitted to the
QIC, or a prior decision-maker.
However, when a provider or supplier,
or beneficiary represented by a provider
or supplier, fails to include the required
statement, OMHA ALJs and staff spend
time seeking out the explanation and
following up with parties to fulfill their
obligation. Thus, we are proposing to
revise § 405.1018(c)(2) to state that if the
provider or supplier, or beneficiary
represented by a provider or supplier
fails to include the statement explaining
why the evidence was not previously
submitted, the evidence would not be
considered. Because only the enrollee is
a party to a Part D appeal, there is no
corresponding provision in proposed
§ 423.2016.
We are inviting public comments on
these proposals. If you choose to
comment on the proposals in this
section, please include the caption
‘‘Submitting evidence’’ at the beginning
of your comment.
j. Time and Place for a Hearing Before
an ALJ (§§ 405.1020 and 423.2020)
As the ALJ hearing function
transitioned from SSA, where hearings
could be held at over 140 hearing sites
nation-wide, to OMHA with four field
offices, OMHA became one of the first
agencies to use video-teleconferencing
(VTC) as the default mode of
administrative hearings. The effective
use of VTC mitigated OMHA’s reduced
geographic presence, and allowed
OMHA to operate more efficiently and
at lower cost to the American taxpayers.
However, the preference of most
appellants quickly turned to hearings
conducted by telephone. In FY 2015,
over 98% of hearings before OMHA
ALJs were conducted by telephone.
Telephone hearings provide parties and
their representatives and witnesses with
the opportunity to participate in the
hearing process with minimal
disruption to their day, and require less
administrative burden at even lower
cost to the American taxpayers than
hearings conducted by VTC. OMHA
ALJs also prefer telephone hearings in
most instances, because they allow more
hearings to be conducted without
compromising the integrity of the
hearing. However, when the ALJ
conducting the hearing believes visual
interaction is necessary for a hearing, he
or she may conduct a VTC hearing, and
when special circumstances are
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presented, ALJs may conduct in-person
hearings.
Despite the shift in preferences for
most appellants to telephone hearings,
current § 405.1020 still makes VTC the
default mode of hearing, with the option
to offer a telephone hearing to
appellants. In fact, some appellants have
required the more expensive VTC
hearing even when their representative
is presenting only argument and no
testimony is being offered. We believe
this is inefficient and results in wasted
time and resources that could be
invested in adjudicating additional
appeals, and unnecessarily increases the
administrative burdens and costs on the
government for conducting a hearing
with little to no discernable benefit to
the parties in adjudicating denials of
items or services that have already been
furnished. Based on these
considerations, we are proposing that a
telephone hearing be the default
method, unless the appellant is an
unrepresented beneficiary. We believe
this balances the costs and
administrative burdens with the
interests of the parties, recognizing that
unrepresented beneficiaries may have
an increased need and desire to visually
interact with the ALJ.
We are proposing in 405.1020(b) to
provide two standards for determining
how appearances are made, depending
on whether appearances are by
unrepresented beneficiaries or by
individuals other than unrepresented
beneficiaries. The provisions of current
§ 405.1020(b) would be incorporated
into proposed § 405.1020(b)(1) and
revised to be specific to an appearance
by an unrepresented beneficiary who
files a request for hearing. We are
proposing in subsection (b)(1) that the
ALJ would direct that the appearance of
an unrepresented beneficiary who filed
a request for hearing be conducted by
VTC if the ALJ finds that VTC
technology is available to conduct the
appearance, unless the ALJ finds good
cause for an in-person appearance. As in
the current rule, we also are proposing
in § 405.1020(b)(1) to allow the ALJ to
offer to conduct a telephone hearing if
the request for hearing or administrative
record suggests that a telephone hearing
may be more convenient to the
unrepresented beneficiary. The current
standard for determining whether an inperson hearing should be conducted
involves a finding that VTC technology
is not available or special or
extraordinary circumstances exist.
Because, absent special or extraordinary
circumstances, a hearing could still be
conducted by telephone if VTC
technology were unavailable, we are
proposing that the standard for an in-
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person hearing be revised to state that
VTC or telephone technology is not
available or special or extraordinary
circumstances exist, and the
determination would be characterized
as finding good cause for an in-person
hearing, to align with current
§ 405.1020(i)(5), which provides for
granting a request for an in-person
hearing on a finding of good cause. We
also are proposing in §§ 405.1020(b)(1)
and 405.1020(i)(5) to replace the
reference to obtaining the concurrence
of the ‘‘Managing Field Office ALJ’’ with
the ‘‘Chief ALJ or designee.’’ The
position of the Managing Field Office
ALJ became what is now an Associate
Chief ALJ, see 80 FR 2708, and using
‘‘Chief ALJ or designee’’ would provide
OMHA with the flexibility to designate
the appropriate individual regardless of
future organizational changes. We are
proposing to adopt these revisions in
proposed §§ 423.2020(b)(1), for
appearances by unrepresented enrollees
and 423.2020(i)(5), for when an ALJ may
grant a request for an in-person hearing.
We are also proposing in
§ 405.1020(b)(1) to replace
‘‘videoteleconferencing,’’ with ‘‘videoteleconferencing,’’ for consistency with
terminology used in §§ 405.1000,
405.1036, 423.2000, 423.2020 and
423.2036.
Proposed § 405.1020(b)(2) addresses
appearances by an individual other than
an unrepresented beneficiary who files
a request for hearing. We are proposing
in § 405.1020(b)(2) that the ALJ would
direct that those individuals appear by
telephone, unless the ALJ finds good
cause for an appearance by other means.
Further, we are proposing in
§ 405.1020(b)(2) that the ALJ may find
good cause for an appearance by VTC if
he or she determines that VTC is
necessary to examine the facts or issues
involved in the appeal. Also, we are
proposing that the ALJ, with the
concurrence of the Chief ALJ or
designee, may find good cause that an
in-person hearing should be conducted
if VTC and telephone technology are not
available, or special or extraordinary
circumstances exist. We are proposing
to adopt these revisions in
§ 423.2020(b)(2) for appearances by
represented enrollees, which is more
specific than proposed § 405.1020(b)(2)
because only enrollees are parties to
appeals under part 423, subpart U, and
the provisions of subsection (b)(2)
would apply only to appearances by
represented enrollees.
Current § 405.1020(c)(1) states that the
ALJ sends a notice of hearing. This has
caused confusion as to whether the ALJ
must personally sign the notice, or
whether it can be sent at the direction
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of the ALJ. We believe that the notice
may be sent at the direction of the ALJ,
and requiring an ALJ signature adds an
unnecessary step in the process of
issuing the notice. Therefore, we are
proposing in § 405.1020(c)(1) that a
notice of hearing be sent without further
qualification, and to let other provisions
indicate the direction that is necessary
from the ALJ in order to send the notice,
such as § 405.1022(c)(1), which provides
that the ALJ sets the time and place of
the hearing. We are proposing to adopt
these provisions in § 423.2020(a)(1).
Current § 405.1020(c)(1) also requires
that the notice of hearing be sent to the
parties who filed an appeal or
participated in the reconsideration, any
party who was found liable for the
services at issue subsequent to the
initial determination, and the QIC that
issued the reconsideration. However,
there are instances in which a party who
does not meet the criteria may face
liability because the ALJ may consider
a new issue based on a review of the
record. To address this, we are
proposing in § 405.1020(c)(1) to add that
a party that may be found liable based
on a review of the record must be sent
a notice of hearing. In addition, current
§ 405.1020 does not address notices of
hearing sent to CMS or a non-QIC
contractor. Currently, ALJs may also
send a notice of hearing to CMS or a
contractor when the ALJ believes their
input as a participant or party may be
beneficial. We are proposing in
§ 405.1020(c)(1) that the notice of
hearing also be sent to CMS or a
contractor that the ALJ believes would
be beneficial to the hearing. We are not
proposing any corresponding revisions
to current § 423.2020(c)(1) because only
enrollees are parties to appeals under
part 423, subpart U.
OMHA ALJs have expressed concern
that parties and representatives who
appear at a hearing with multiple
individuals and witnesses who were not
previously identified, complicate and
slow the hearing process. While a party
or representative has considerable
leeway in determining who will attend
the hearing or be called as a witness,
prior notice of those individuals is
necessary for the ALJs to schedule
adequate hearing time, manage their
dockets, and conduct the hearing. To
address these concerns, we are
proposing at § 405.1020(c)(2)(ii) to add a
requirement to specify the individuals
from the entity or organization who plan
to attend the hearing if the party or
representative is an entity or
organization, and at subsection (c)(2)(iii)
to add a requirement to list the
witnesses who will be providing
testimony at the hearing, in the response
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to the notice of hearing. We also are
proposing to consolidate the provisions
in current § 405.1020(c)(2)(i) and
(c)(2)(ii) in proposed § 405.1020(c)(2)(i)
to simplify the provisions related to the
current requirements for replying to the
notice of hearing. Thus, proposed
subsection (c)(2)(i) would require all
parties to the ALJ hearing to reply to the
notice by acknowledging whether they
plan to attend the hearing at the time
and place proposed in the hearing, or
whether they object to the proposed
time and/or place of the hearing. We are
proposing at § 423.2020(c)(2) to adopt
corresponding revisions for an
enrollee’s or his or her representative’s
reply to the notice of hearing.
We also are proposing in
§ 405.1020(c)(2) to remove the provision
for CMS or a contractor that wishes to
participate in the hearing to reply to the
notice of hearing in the same manner as
a party because a non-party may not
object to the proposed time and place of
the hearing, or present witnesses.
Instead, we are proposing in
§ 405.1020(c)(3) to require CMS or a
contractor that wishes to attend the
hearing as a participant to reply to the
notice of hearing by acknowledging
whether it plans to attend the hearing at
the time and place proposed in the
notice of hearing, and specifying who
from the entity plans to attend the
hearing. We are proposing at
§ 423.2020(c)(3) to adopt corresponding
revisions for CMS’, the IRE’s, or the Part
D plan sponsor’ reply to the notice of
hearing when the entity requests to
attend the hearing as a participant.
In discussing a party’s right to waive
a hearing, current § 405.1020(d) states
that a party may waive the right to a
hearing and request that the ALJ issue
a decision based on the written
evidence in the record. In light of
proposed § 405.1038(b), which would
allow attorney adjudicators to issue
decisions in appeals that do not require
hearings on the record without an ALJ
conducting a hearing in certain
situations, we are proposing in
§ 405.1020(d) to state that a party also
may waive the right to a hearing and
request a decision based on the written
evidence in the record in accordance
with § 405.1038(b), but an ALJ may
require the parties to attend a hearing if
it is necessary to decide the case. We are
proposing at § 423.2020(d) to adopt
corresponding revisions for an enrollee
to waive his or her right to a hearing and
request a decision based on the written
evidence in the record in accordance
with § 423.2038(b), but an ALJ could
require the enrollee to attend a hearing
if it is necessary to decide the case.
These references would direct readers to
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the section that provides the authority
for a decision based on the written
record, which would provide them with
a complete explanation of when the
authority may be used and notify them
that an ALJ or attorney adjudicator may
issue the decision.
In addressing the ALJ’s authority to
change the time or place of the hearing
if the party has good cause to object,
current § 405.1020(e) requires a party to
make the request to change the time or
place of the hearing in writing.
However, on occasion, a party may need
to request a change on the day prior to,
or the day of a hearing due to an
emergency, such as a sudden illness or
injury, or inability to get to a site for the
hearing. In this circumstance, we
believe an oral request should be
permitted. Therefore, we are proposing
in § 405.1020(e)(3) that the request must
be in writing, except that a party may
orally request that a hearing be
rescheduled in an emergency
circumstance the day prior to or day of
the hearing, and the ALJ must document
the oral request in the administrative
record. We are proposing at
§ 423.2020(e)(3) to adopt a
corresponding provision for an enrollee
to orally request a rescheduled standard
hearing, and to modify the
documentation requirement, which is
currently limited to documenting oral
requests made for expedited hearings, to
include all oral objections.
In addition, current §§ 405.1020(e)(4)
and 423.2020(e)(4), which explain the
ALJ may change the time or place of the
hearing if the party has good cause,
contain a parenthetical that references
the procedures that an ALJ follows
when a party does not respond to a
notice of hearing and fails to appear at
the time and place of the hearing. The
parenthetical does not appear to address
or assist in understanding the
circumstances covered by current
§§ 405.1020(e)(4) and 423.2020(e)(4),
and we, therefore, are proposing to
remove the parenthetical from the
respective sections.
Current §§ 405.1020(g)(3) and
423.2020(g)(3) provide a list of examples
of circumstances a party might give for
requesting a change in the time or place
of the hearing. We have heard from ALJs
and stakeholders that it would be
helpful to also include the following
two additional examples: (1) The party
or representative has a prior
commitment that cannot be changed
without significant expense, in order to
account for circumstances in which
travel or other costly events may
conflict with the time and place of a
hearing, which the ALJ may determines
warrants good cause for changing the
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time or place of the hearing; and (2) the
party or representative asserts that he or
she did not receive the notice of hearing
and is unable to appear at the scheduled
time and place, which the ALJ may
determine warrants good cause for
changing the time or place of the
hearing. We are proposing in
§§ 405.1020(g)(3)(vii) and (viii), and
423.1020(g)(3)(vii) and (viii) to add
these two examples to address these
circumstances. We believe these
additional examples would provide
greater flexibility in the appeals process
and better accommodate the needs of
appellants.
We are proposing in §§ 405.1020(h)
and 423.2020(h) to revise the references
to the adjudication ‘‘deadline’’ with
references to the adjudication ‘‘period,’’
for consistency in terminology with the
specified cross-references.
We are proposing revisions to
§ 405.1020(i) to align the provision with
proposed § 405.1020(b). We are
proposing in § 405.1020(i) that if an
unrepresented beneficiary who filed the
request for hearing objects to a VTC
hearing or to the ALJ’s offer to conduct
a hearing by telephone, or if a party
other than an unrepresented beneficiary
who filed the request for hearing objects
to a telephone or VTC hearing, the party
must notify the ALJ at the earliest
possible opportunity before the time set
for the hearing and request a VTC or inperson hearing. The party would be
required to state the reason for the
objection and the time and/or place that
he or she wants an in-person or VTC
hearing to be held, and the request must
be in writing. We are proposing in
§ 405.1020(i)(4) to incorporate the
current § 405.1020(i)(4) provision that
requires the appeal to be adjudicated
within the time frame specified in
§ 405.1016 if a request for an in-person
or VTC hearing is granted unless the
party waives the time frame in writing.
However, we are proposing at
§ 405.1020(i)(4) to revise the language to
more accurately state that the ALJ issues
a ‘‘decision, dismissal, or remand to the
QIC,’’ rather than just a ‘‘decision,’’
within the adjudication time frame
specified in § 405.1016. We are
proposing revisions to § 423.2020(i) to
align the provision with proposed
§ 423.2020(b). We are proposing in
§ 423.2020(i) that if an unrepresented
enrollee who filed the request for
hearing objects to a VTC hearing or to
the ALJ’s offer to conduct a hearing by
telephone, or if a represented enrollee
who filed the request for hearing objects
to a telephone or VTC hearing, the
enrollee or representative must notify
the ALJ at the earliest possible
opportunity before the time set for the
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hearing and request a VTC or in-person
hearing. The enrollee would be required
to state the reason for the objection and
the time and/or place that he or she
wants an in-person or VTC hearing to be
held. We are proposing in
§ 423.2020(i)(4) to incorporate the
current § 423.2020(i)(4) provision with
some modifications so that the appeal
would be adjudicated within the time
frame specified in § 423.2016 if a
request for an in-person or VTC hearing
is granted unless the party waives the
time frame in writing. We are proposing
at § 423.2020(i)(4) to revise the language
to more accurately state that the ALJ
issues a ‘‘decision, dismissal, or remand
to the IRE,’’ rather than just a
‘‘decision,’’ within the adjudication
time frame specified in § 405.1016 and
to include requests for VTC hearings as
well as requests for in-person hearings.
In addition, we are proposing at
§§ 405.1020(i)(5) and 423.2020(i)(5) to
provide that upon a finding of good
cause, a hearing would be rescheduled
at a time and place when the party may
appear in person or by VTC, to account
for objections to VTC hearings as well
as objections to telephone hearings or
offers to conduct a hearing via
telephone. We are also proposing to
replace ‘‘concurrence of the Managing
Field Office ALJ’’ with ‘‘concurrence of
the Chief ALJ or a designee’’ because the
position of Managing Field Office ALJ
was replaced by the position of
Associate Chief ALJ (80 FR 2708) and
providing a more general reference
would provide greater flexibility in the
future as position titles change.
Current §§ 405.1020 and 423.2020 do
not address what occurs when the ALJ
changes the time or place of the hearing.
We are proposing at § 405.1020(j) to add
a provision titled ‘‘Amended notice of
hearing’’ to clarify that, if the ALJ
changes or will change the time and/or
place of the hearing, an amended notice
of hearing must be sent to all of the
parties who were sent a copy of the
notice of hearing and CMS or its
contractors that elected to be a
participant or party to the hearing, in
accordance with the procedures of
§ 405.1022(a), which addresses issuing a
notice of hearing. We are proposing at
§ 423.2020(j) to add a provision to
clarify that, if the ALJ changes or will
change the time and/or place of the
hearing, an amended notice of hearing
must be sent to the enrollee and CMS,
the IRE, and/or the Part D plan sponsor
in accordance with the procedures of
§ 423.2022(a), which addresses issuing a
notice of hearing. These would help
ensure that if changes are made to the
time or place of the hearing, a new
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notice is issued or waivers are obtained
in a consistent manner.
We are inviting public comments on
these proposals. If you choose to
comment on the proposals in this
section, please include the caption
‘‘Time and place for a hearing before an
ALJ’’ at the beginning of your comment.
k. Notice of a Hearing Before an ALJ and
Objections to the Issues (§§ 405.1022,
405.1024, 423.2022, and 423.2024)
Current § 405.1022(a) provides that a
notice of hearing will be mailed or
personally served to the parties and
other potential participants, but a notice
is not sent to a party who indicates in
writing that it does not wish to receive
the notice. Current § 423.2022(a)
provides that a notice of hearing will be
mailed or otherwise transmitted, or
personally served, unless the enrollee or
other potential participant indicates in
writing that he or she does not wish to
receive the notice. However, currently
§ 405.1022(a) is limiting because it does
not contemplate transmitting the notice
by means other than mail or personal
service even though technologies
continue to develop and notice could be
provided by secure email or a secure
portal. Also, notices must be sent in
accordance with any OMHA procedures
that apply, such as procedures to protect
personally identifiable information. In
addition, the exception in current
§ 405.1022(a) does not contemplate a
scenario in which a potential
participant indicates that it does not
wish to receive the notice, as is
provided for in current § 423.2022(a).
We are proposing in §§ 405.1022(a) and
423.2022(a) to address these issues and
align the sections by providing that a
notice of hearing would be mailed or
otherwise transmitted in accordance
with OMHA procedures, or personally
served, except to a party or other
potential participant who indicates in
writing that he or she does not wish to
receive the notice.
Current §§ 405.1022(a) and
423.2022(a) provide that a notice of
hearing does not have to be sent to a
party who indicates in writing that it
does not wish to receive the notice and
that the notice is mailed or served at
least 20 calendar days (for Parts A and
B and for non-expedited Part D
hearings), or 3 calendar days (for
expedited Part D hearings) before the
hearing. The provisions do not address
the situation where a party wishes to
receive the notice, but agrees to the
notice being mailed fewer than 20
calendar days (or 3 calendar days if
expedited) before the hearing, which
may be necessary to accommodate an
appellant’s request to conduct a hearing
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in fewer than 20 or 3 calendar days. We
are proposing to revise §§ 405.1022(a)
and 423.2022(a) to address this situation
by providing the notice is mailed,
transmitted, or served at least 20
calendar days (or 3 calendar days if
expedited) before the hearing unless the
recipient agrees in writing to the notice
being mailed, transmitted, or served
fewer than 20 calendar days (or 3
calendar days if expedited) before the
hearing. However, we note that like a
recipient’s waiver of receiving a notice
of hearing, a recipient’s waiver of the
requirement to mail, transmit, or serve
the notice at least 20 or 3 calendar days
(as applicable) before the hearing would
only be effective for the waiving
recipient and does not affect the rights
of other recipients.
Current § 405.1022(b)(1) requires a
notice of hearing to contain a statement
of the specific issues to be decided and
inform the parties that they may
designate a person to represent them
during the proceedings. These
statements of issues take time to
develop, and current § 405.1032, which
addresses the issues before an ALJ,
provides that the issues before the ALJ
are all the issues brought out in the
initial determination, redetermination,
or reconsideration that were not decided
entirely in a party’s favor. Current
§ 405.1032 also permits an ALJ to
consider a new issue at the hearing, if
notice of the new issue is provided to
all parties before the start of the hearing.
To streamline the notice of hearing,
rather than require the notice of hearing
to contain a statement of the specific
issues to be decided, we are proposing
in § 405.1022(b)(1) to require the notice
of hearing to include a general statement
putting the parties on notice that the
issues before the ALJ include all of the
issues brought out in the initial
determination, redetermination, or
reconsideration that were not decided
entirely in a party’s favor, for the claims
specified in the request for hearing. This
is consistent with the standard for
determining the issues before the ALJ in
proposed § 405.1032(a). However, we
also are proposing in § 405.1022(b)(1)
that the notice of hearing also would
contain a statement of any specific new
issues that the ALJ will consider in
accordance with § 405.1032 to help
ensure the parties and potential
participants are provided with notice of
any new issues of which the ALJ is
aware at the time the notice of hearing
is sent, and can prepare for the hearing
accordingly. For example, if in the
request for hearing an appellant raises
an issue with the methodology used to
sample claims and extrapolate an
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overpayment, and that issue had not
been brought out in the initial
determination, redetermination, or
reconsideration, the issue would be a
new issue and the specific issue would
be identified in the notice of hearing. To
accommodate proposed
§ 405.1022(b)(1), we are proposing that
the portion of current § 405.1022(b)(1)
that requires the notice of hearing to
inform the parties that they may
designate a person to represent them
during the proceedings would be redesignated as § 405.1022(b)(2), and
current subsections (b)(2), (b)(3), and
(b)(4) would be re-designated as
subsections (b)(3), (b)(4), and (b)(5),
respectively. We are proposing at
§ 423.2022(b) to adopt corresponding
revisions for notice information in part
423, subpart U proceedings.
Current § 405.1022(c)(1) provides that
if the appellant, any other party to the
reconsideration to whom the notice of
hearing was sent, or their representative
does not acknowledge receipt of the
notice of hearing, the ALJ hearing office
attempts to contact the party for an
explanation. We are proposing to
replace ‘‘ALJ hearing office’’ with
‘‘OMHA’’ because OMHA is the
responsible entity.
Current § 405.1022(c)(2) provides that
if a party states that he or she did not
receive the notice of hearing, an
amended notice is sent to him or her.
The reference to an amended notice has
caused confusion, as the original notice
does not need to be amended unless the
hearing is rescheduled. We are
proposing in § 405.1022(c)(2) to remove
the reference to an ‘‘amended’’ notice of
hearing and provide that a copy of the
notice of hearing is sent to the party.
However, if a party cannot attend the
hearing, we are proposing in new
§ 405.1022(c)(3) that the party may
request that the ALJ reschedule the
hearing in accordance with proposed
§ 405.1020(e), which discusses a party’s
objection to the time and place of
hearing. We are proposing at
§ 423.2022(c) to adopt corresponding
revisions for providing a copy of the
notice of hearing if the enrollee did not
acknowledge it and states that he or she
did not receive it in part 423, subpart U
proceedings.
Current § 405.1022(c)(2) provides that
if a party did not receive the notice of
hearing, a copy of the notice may be
sent by certified mail or email, if
available. Current § 423.2022(c)(2)
provides an additional option to send
the copy by fax. However, use of email
to send documents that contain a
beneficiary’s or enrollee’s personally
identifiable information is not currently
permitted by OMHA policy, and faxes
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must be sent in accordance with
procedures to protect personally
identifiable information. We are
proposing in §§ 405.1022(c)(2) and
423.2022(c)(2) to remove the references
to using email and fax, and to add that
a notice may be sent by certified mail
or other means requested by the party
and in accordance with OMHA
procedures. This would provide the
flexibility to develop alternate means of
transmitting the request and allow
OMHA to help ensure necessary
protections are in place to comply with
HHS information security policies.
Finally, the parenthetical in current
§§ 405.1022(c)(2) and 423.2022(c)(2) is
not applicable. We believe it was
attempting to cross-reference the
provision related to requesting a
rescheduled hearing. Therefore, we are
proposing in §§ 405.1022(c)(2) and
423.2022(c)(2) to remove the
parenthetical. As discussed above,
proposed §§ 405.1022(c)(3) and
423.2022(c)(3) would address the option
for a party to request a rescheduled
hearing and contain the correct crossreference.
Current § 405.1024 sets forth the
provision regarding objections by a
party to the issues described in the
notice of hearing. Current § 405.1024(b)
requires a party to send a copy of its
objection to the issues to all other
parties to the appeal. We are proposing
to revise § 405.1024(b) to provide that
the copy is only sent to the parties who
were sent a copy of the notice of
hearing, and CMS or a contractor that
elected to be a party to the hearing,
because we believe sending a copy of
the objection to additional parties is
unnecessary and causes confusion for
parties who were not sent a copy of the
notice of hearing. No corresponding
change is proposed in § 423.2024
because only the enrollee is a party.
Current § 405.1024(c) states that an
ALJ makes a decision on the objection
to the issues either in writing or at the
hearing. We are proposing to revise
§ 405.1024(c) to add the option for an
ALJ to make a decision on the objections
at a prehearing conference, which is
conducted to facilitate the hearing, as
well as at the hearing. We believe this
added flexibility would allow ALJs to
discuss the objections with the parties
and make a decision on the record
before the hearing at the prehearing
conference. However, we note that the
ALJ’s decision on an objection to the
issues at a prehearing conference
pursuant to proposed § 405.1024(c)
would not be subject to the objection
process for a prehearing conference
order under § 405.1040(d). A decision
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agreement or action resulting from the
prehearing conference, but rather the
ALJ’s decision on a procedural matter
for which the ALJ has discretion, and
we do not believe the parties should
have a right of veto through the
prehearing conference order objection
process. We also are proposing at
§ 423.2024(c) to adopt a corresponding
revision for a decision on an objection
to the issues in part 423, subpart U
proceedings.
We are inviting public comments on
these proposals. If you choose to
comment on the proposals in this
section, please include the caption
‘‘Notice of a hearing before an ALJ and
objections to the issue’’ at the beginning
of your comment.
l. Disqualification of the ALJ or Attorney
Adjudicator (§§ 405.1026 and 423.2026)
Current § 405.1026 provides a process
for a party to request that an ALJ
disqualify himself or herself from an
appeal, or for an ALJ to disqualify
himself or herself from an appeal on the
ALJ’s own motion. We are proposing to
revise § 405.1026 to replace the current
references to conducting a hearing with
references to adjudicating an appeal, to
make it is clear that disqualification is
not limited to ALJs or cases where a
hearing is conducted to help ensure that
an attorney adjudicator, as proposed in
section II.B above, also cannot
adjudicate an appeal if he or she is
prejudiced or partial to any party, or has
any interest in the matter pending for
decision. Current § 405.1026(b) requires
that, if a party objects to the ALJ who
will conduct the hearing, the party must
notify the ALJ within 10 calendar days
of the date of the notice of hearing. The
ALJ considers the party’s objections and
decides whether to proceed with the
hearing or withdraw. However, the
current rule does not address appeals
for which no hearing is scheduled and/
or no hearing will be conducted.
Therefore, we are proposing to revise
§ 405.1026(b) to require that if a party
objects to the ALJ or attorney
adjudicator assigned to adjudicate the
appeal, the party must notify the ALJ
within 10 calendar days of the date of
the notice of hearing if a hearing is
scheduled, or the ALJ or attorney
adjudicator any time before a decision,
dismissal order, or remand order is
issued if no hearing is scheduled. We
also are proposing to revise
§ 405.1026(c) to state that an ALJ or
attorney adjudicator is ‘‘assigned’’ to
adjudicate an appeal, rather than
‘‘appointed,’’ for consistency in
terminology, and to replace ‘‘hearing
decision’’ with ‘‘decision or dismissal’’
because not all decisions are issued
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following a hearing and an appellant
may have objected in an appeal that was
dismissed, for which review may also be
requested from the Council. In addition,
we are proposing to add ‘‘if applicable’’
in discussing that the Council would
consider whether a new hearing is held
because not all appeals may have had or
require a hearing. We are proposing at
§ 423.2026 to adopt corresponding
revisions for disqualification of an ALJ
or attorney adjudicator in part 423,
subpart U proceedings.
Current § 405.1026 does not address
the impact of a party objection and
adjudicator’s withdrawal on an
adjudication time frame. The
withdrawal of an adjudicator and reassignment of an appeal will generally
cause a delay in adjudicating the appeal.
We are proposing in new § 405.1026(d)
that if the party objects to the ALJ or
attorney adjudicator, and the ALJ or
attorney adjudicator subsequently
withdrawals from the appeal, any
applicable adjudication time frame that
applies is extended by 14 calendar days.
This would allow the appeal to be reassigned and for the new adjudicator to
review the appeal. We are proposing at
§ 423.2026(d) to adopt a corresponding
provision for the effect of a
disqualification of an adjudicator on an
adjudication time frame in part 423,
subpart U proceedings, but are
proposing that if an expedited hearing is
scheduled, the time frame is extended
by 2 calendar days, to balance the need
for the newly assigned adjudicator to
review the appeal, and the enrollee’s
need to receive a decision as quickly as
possible.
We are inviting public comments on
these proposals. If you choose to
comment on the proposals in this
section, please include the caption
‘‘Disqualification of the ALJ or attorney
adjudicator’’ at the beginning of your
comment.
m. Review of Evidence Submitted by the
Parties (§ 405.1028)
Current § 405.1028 addresses the
prehearing review of evidence
submitted to the ALJ. We are proposing
to revise the title of § 405.1028 to reflect
that the regulation would more broadly
apply to the review of evidence
submitted by the parties because a
hearing may not be conducted and an
attorney adjudicator would review
evidence in deciding appeals as
proposed in section II.B above.
Proposed § 405.1028(a) would
incorporate current § 405.1028(a) to
address new evidence. Current
§ 405.1028(a) states that after a hearing
is requested but before it is held, the
ALJ will examine any new evidence
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submitted with the request for hearing
(or within 10 calendar days of receiving
the notice of hearing) as specified in
§ 405.1018, by a provider, supplier, or
beneficiary represented by a provider or
supplier to determine whether there was
good cause for submitting evidence for
the first time at the ALJ level. However,
this provision and the other provisions
in current § 405.1028 do not address the
review of new evidence when no
hearing is conducted for an appeal.
Therefore, we are proposing to revise
§ 405.1028(a) to add § 405.1028(a)(1),
(2), (3), and (4), and are proposing in
§ 405.1028(a)(1) that after a hearing is
requested but before it is held by an ALJ
(to reinforce that hearings are only
conducted by ALJs), or a decision is
issued if no hearing is held, the ALJ or
attorney adjudicator would review any
new evidence. In addition, we are
proposing in § 405.1028(a)(1) to remove
the duplicative statement indicating the
review is conducted on ‘‘any new
evidence submitted with the request for
hearing (or within 10 calendar days of
receiving the notice of hearing) as
specified in § 405.1018,’’ because
§ 405.1018 discusses when evidence
may be submitted prior to a hearing and,
as explained in III.A.3.i above, proposed
§ 405.1018 would revise the language
that is duplicated in current § 405.1028.
We believe that the better approach
going forward is simply to reference
§ 405.1018 by indicating that the review
is conducted on ‘‘any new evidence
submitted in accordance with
§ 405.1018.’’ This would remind parties
that evidence must be submitted in
accordance with § 405.1018, while
minimizing confusion on which section
is authoritative with regard to when
evidence may be submitted.
In a 2012 OIG report on the ALJ
hearing process (OEI–02–10–00340), the
OIG reported concerns regarding the
acceptance of new evidence in light of
the statutory limitation at section
1869(b)(3) of the Act on new evidence
submitted by providers and suppliers.
The OIG concluded that the current
regulations regarding the acceptance of
new evidence provide little guidance
and only one example of good cause,
and recommended revising the
regulations to provide additional
examples and factors for ALJs to
consider when determining good cause.
Section 1869(b)(3) of the Act states
that a provider or supplier may not
introduce evidence in any appeal that
was not presented at the QIC
reconsideration unless there is good
cause which precluded the introduction
of such evidence at or before that
reconsideration. This section presents a
Medicare-specific limitation on
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submitting new evidence, and therefore
limits the authority of an ALJ to accept
new evidence under the broader APA
provisions (see 5 U.S.C. 556(c)(3)
(‘‘Subject to published rules of the
agency and within its power, employees
presiding at hearings may– . . . receive
relevant evidence . . . .’’)). Section
1869(b)(3) of the Act also presents a
clear intent by Congress to limit the
submission of new evidence after the
QIC reconsideration, which must be
observed.
In light of the OIG conclusion and
recommendation and to more effectively
implement section 1869(b)(3) of the Act,
we are proposing to incorporate current
§ 405.1028(b) in proposed
§ 405.1028(a)(2) on when an ALJ could
find good cause for submitting evidence
for the first time at the OMHA level, and
to establish four additional
circumstances in which good cause for
submitting new evidence may be found.
We are also proposing to permit an
attorney adjudicator to find good cause
because attorney adjudicators would be
examining new evidence in deciding
appeals on requests for an ALJ hearing
as proposed in section II.B above, and
we believe the same standard for
considering evidence should apply.
We are proposing in
§ 405.1028(a)(2)(i) to adopt the example
in current § 405.1028(b) and provide
that good cause is found when the new
evidence is, in the opinion of the ALJ or
attorney adjudicator, material to an
issue addressed in the QIC’s
reconsideration and that issue was not
identified as a material issue prior to the
QIC’s reconsideration.
We are proposing in
§ 405.1028(a)(2)(ii) to provide that good
cause is found when the new evidence
is, in the opinion of the ALJ, material to
a new issue identified in accordance
with § 405.1032(b). This would provide
parties with an opportunity to submit
new evidence to address a new issue
that was identified after the QIC’s
reconsideration. However, the authority
is limited to ALJs because, as discussed
in proposed § 405.1032, only an ALJ
may raise a new issue on appeal.
We are proposing in
§ 405.1028(a)(2)(iii) to provide that good
cause is found when the party was
unable to obtain the evidence before the
QIC issued its reconsideration and the
party submits evidence that, in the
opinion of the ALJ or attorney
adjudicator, demonstrates that the party
made reasonable attempts to obtain the
evidence before the QIC issued its
reconsideration. For example, if specific
medical records are necessary to
support a provider’s or supplier’s claim
for items or services furnished to a
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beneficiary, the provider or supplier
must make reasonable attempts to
obtain the medical records, such as
requesting records from a beneficiary or
the beneficiary’s physician when it
became clear the records are necessary
to support the claim, and following up
on the request. Obtaining medical
records, in some cases from another
health care professional, and submitting
those records to support a claim for
services furnished to a beneficiary is a
basic requirement of the Medicare
program (see sections 1815(a) and
1833(e) of the Act, and § 424.5(a)(6)),
and we expect instances where records
cannot be obtained in the months
leading up to a reconsideration should
be rare. If the provider or supplier was
unable to obtain the records prior to the
QIC issuing its reconsideration, good
cause for submitting the evidence after
the QIC’s reconsideration could be
found when the ALJ or attorney
adjudicator determines that the provider
or supplier submitted evidence that
demonstrates the party made reasonable
attempts to obtain the evidence before
the QIC issued its reconsideration.
We are proposing at
§ 405.1028(a)(2)(iv) to provide that good
cause is found when the party asserts
that the evidence was submitted to the
QIC or another contractor and the party
submits evidence that, in the opinion of
the ALJ or attorney adjudicator,
demonstrates that the new evidence was
indeed submitted to the QIC or another
contractor before the QIC issued the
reconsideration. For example, if a
provider or supplier submitted evidence
to the QIC or another contractor and
through administrative error, the
evidence is not associated with the
record that is forwarded to OMHA, good
cause may be found when the ALJ or
attorney adjudicator determines that the
provider or supplier submitted evidence
that demonstrates the new evidence was
submitted to the QIC or another
contractor before the QIC issued the
reconsideration.
Finally, we are proposing at
§ 405.1028(a)(2)(v) to provide that in
circumstances not addressed in
proposed paragraphs (i) through (iv), the
ALJ or attorney adjudicator may find
good cause for new evidence when the
ALJ or attorney adjudicator determines
the party has demonstrated that it could
not have obtained the evidence before
the QIC issued its reconsideration. We
expect proposed paragraphs (i) through
(iv) to cover most circumstances in
which a provider or supplier attempts to
introduce new evidence after the QIC
reconsideration, but we believe this
additional provision is necessary to
allow for a good cause finding in any
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other circumstance that meets the
requirements of section 1869(b)(3) of the
Act. Paragraph (v) helps ensure that
OMHA fulfills the statutory requirement
by requiring that the ALJ or attorney
adjudicator make a determination on
whether the party could have obtained
the evidence before the QIC issued its
reconsideration.
To accommodate the new structure of
proposed § 405.1028, we are proposing
that current paragraphs (c) and (d) be redesignated as paragraphs (a)(3) and
(a)(4), respectively. In addition, we are
proposing at § 405.1028(a)(4) that
notification about whether the evidence
would be considered or excluded
applies only when a hearing is
conducted, and notification of a
determination regarding new evidence
would be made only to parties and
participants who responded to the
notice of hearing, since all parties may
not be sent a copy of the notice of
hearing or attend the hearing. We note
that if a hearing is not conducted,
whether the evidence was considered or
excluded would be discussed in the
decision, pursuant to proposed
§ 405.1046(a)(1), as discussed in section
III.A.3.v below. We also are proposing at
§ 405.1028(a)(4) that the ALJ would
notify all parties and participants
whether the new evidence would be
considered or is excluded from
consideration (rather than only whether
the evidence will be excluded from the
hearing) and that this determination
would be made no later than the start of
the hearing, if a hearing is conducted. If
evidence is excluded, it is excluded
from consideration, not just the hearing,
and evidence may be excluded from
consideration even when no hearing is
conducted. We believe that this would
provide greater clarity to parties and
participants regarding the ALJ’s
determination with respect to new
evidence, and the effect of the exclusion
of such evidence on the proceedings.
Current § 405.1028 does not address
duplicative evidence. However,
duplicative evidence is a significant
challenge for OMHA because appellants
often submit copies of medical records
and other submissions that were filed at
prior levels of appeal and are in the
record forwarded to OMHA. While we
recognize that appellants want to ensure
the evidence is in the record and
considered, we are also mindful that the
APA provides that as a matter of policy,
an agency shall provide for the
exclusion of unduly repetitious
evidence (see 5 U.S.C. 556(d)).
We are proposing in § 405.1028(b)
that the ALJ or attorney adjudicator may
exclude from consideration any
evidence submitted by a party at the
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OMHA level that is duplicative of
evidence already in the record
forwarded to OMHA. In addition to
establishing a general policy for the
exclusion of unduly repetitious
evidence, this would reduce confusion
as to which of the multiple copies of
records to review, and would reduce
administrative burden.
We are inviting public comments on
these proposals. If you choose to
comment on the proposals in this
section, please include the caption
‘‘Review of evidence submitted by the
parties’’ at the beginning of your
comment.
n. ALJ Hearing Procedures (§§ 405.1030
and 423.2030)
The APA provides an ALJ with the
authority to regulate the course of a
hearing, subject to the rules of the
agency (see 5 U.S.C. 556(c)(5)). In rare
circumstances, OMHA ALJs have
encountered a party or representative
that makes it difficult or impossible for
the ALJ to regulate the course of a
hearing, or for other parties to present
their side of the dispute. This may occur
when a party or representative
continues to present testimony or
argument on a matter that is not relevant
to the issues before the ALJ, or on a
matter for which the ALJ believes he or
she has sufficient information or on
which the ALJ has already ruled. This
may also occur when a party or
representative is uncooperative,
disruptive, or abusive during the course
of the hearing. Sections 405.1030 and
423.2030 sets forth the rules that govern
ALJ hearing procedures. We are
proposing to revise §§ 405.1030(b) and
423.2030(b) to add provisions to address
these circumstances in a consistent
manner that protects the interests of the
parties and the integrity of the hearing
process. To accommodate these
proposals, we are proposing to redesignate paragraph (b) in both
§§ 405.1030 and 423.2030 as paragraph
(b)(1), and to be consistent with
proposed §§ 405.1018 and 423.2018,
would replace the current language
stating that an ALJ may accept
‘‘documents that are material to the
issues’’ with ‘‘evidence that is material
to the issues,’’ because not all evidence
that may be submitted is documentary
evidence (for example, photographs).
We are proposing in § 405.1030(b)(2)
to address circumstances in which a
party or representative continues with
testimony and argument that are not
relevant to the issues before the ALJ or
that address a matter for which the ALJ
believes he or she has sufficient
information or on which the ALJ has
already ruled. In these circumstances,
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the ALJ may limit testimony and/or
argument at the hearing, and may, at the
ALJ’s discretion, provide the party or
representative with an opportunity to
submit additional written statements
and affidavits on the matter in lieu of
testimony and/or argument at the
hearing, within a time frame designated
by the ALJ. Proposed § 405.1030(b)(2)
would allow the ALJ to effectively
regulate the course of the hearing by
providing the ALJ with the clear
authority to limit testimony and/or
argument during the hearing, while
providing an avenue for the ALJ to
allow the testimony and/or argument to
be entered into the record. We are
proposing at § 423.2030(b)(2) to adopt a
corresponding revision for limiting
testimony and argument at a hearing,
and at the ALJ’s discretion, provide an
opportunity to submit additional
written statements and affidavits in part
423, subpart U proceedings.
We are proposing at § 405.1030(b)(3)
to address circumstances in which a
party or representative is uncooperative,
disruptive, or abusive during the course
of the hearing. In these circumstances,
we are proposing that the ALJ would
have the clear authority to excuse the
party or representative from the hearing
and continue with the hearing to
provide the other parties and
participants with the opportunity to
offer testimony and/or argument.
However, in this circumstance, the ALJ
would be required to provide the
excused party or representative with an
opportunity to submit written
statements and affidavits in lieu of
testimony and/or argument at the
hearing. Further, the party also would
be allowed to request a copy of the
audio recording of the hearing in
accordance with § 405.1042 and
respond in writing to any statements
made by other parties or participants
and/or testimony of the witnesses at the
hearing, within a time frame designated
by the ALJ. These proposals would
allow the ALJ to effectively regulate the
course of the hearing and balance the
excused party’s right to present his or
her case, present rebuttal evidence, and
cross-examine the witnesses of other
parties with allowing the party to
submit written statements and
affidavits. We are proposing at
§ 423.2030(b)(3) to adopt a
corresponding revision for excusing an
enrollee or representative who is
uncooperative, disruptive, or abusive
during the hearing in part 423, subpart
U proceedings.
Current § 405.1030(c) addresses
evidence that the ALJ determines is
missing at the hearing, and provides
that if the evidence is in the possession
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of the appellant, and the appellant is a
provider, supplier, or a beneficiary
represented by a provider or supplier,
the ALJ must determine whether the
appellant had good cause for not
producing the evidence earlier. We are
proposing to revise § 405.1030(c) to add
that the ALJ must determine whether
the appellant had good cause in
accordance with § 405.1028 for not
producing the evidence. Section
1869(b)(3) of the Act applies to limit
submission of all new evidence after the
QIC reconsideration by a provider or
supplier absent good cause, and the
proposed addition would create
consistent application of the standards
for determining whether there is good
cause to admit new evidence, regardless
of when the evidence is submitted after
the QIC reconsideration. We are not
proposing any corresponding changes to
current § 423.2030(c) because the
limitation on new evidence does not
apply in part 423, subpart U
proceedings.
Current § 405.1030(d) and (e) discuss
what happens if an ALJ determines
there was or was not good cause for not
producing the new evidence earlier.
Current § 405.1030(d) provides that if
the ALJ determines that good cause
exists, the ALJ considers the evidence in
deciding the case, and the adjudication
period is tolled from the date of the
hearing to the date that the evidence is
submitted. Current § 405.1030(e)
provides that if the ALJ determines that
good cause does not exist, the evidence
is excluded, with no impact on an
applicable adjudication period. Current
§ 405.1030(d) and (e) have caused
confusion in light of § 405.1018, which
indicates that the adjudication period
will be affected if evidence is submitted
later than 10 calendar days after receipt
of the notice of hearing, unless the
evidence is submitted by an
unrepresented beneficiary. It has also
potentially created an incentive for
appellants to disregard § 405.1018
because current § 405.1030(b) appears to
allow evidence to be submitted at the
hearing without affecting the
adjudication time frame; and
§ 405.1030(c) allows the ALJ to stop a
hearing temporarily if there is material
evidence missing, with the effect of
tolling the adjudication time frame from
the date of the hearing to the date the
evidence is submitted, if the evidence is
in the possession of an appellant who is
a provider or supplier or beneficiary
represented by a provider or supplier,
and the ALJ finds good cause to admit
the evidence. In addition, OMHA ALJs
have expressed concern that current
§ 405.1030(e) does not affect the
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adjudication period when an equal
amount of time is spent reviewing
evidence and making a good cause
determination, regardless of whether
good cause is found.
Therefore, we are proposing to revise
§ 405.1030(d) to address the effect of an
evidentiary submission on an
adjudication period. We are proposing
in § 405.1030(d) that any applicable
adjudication period is extended in
accordance with proposed § 405.1018(b)
if an appellant other than an
unrepresented beneficiary submits
evidence pursuant to proposed
§ 405.1030(b), which generally allows
for submission of evidence at the
hearing, or proposed § 405.1030(c),
which specifically addresses evidence
that the ALJ determines is missing at the
hearing. Under proposed § 405.1018(b),
any adjudication period that applies to
the appeal would be extended by the
number of days starting 10 calendar
days after receipt of the notice of
hearing, and ending when the evidence
is submitted, whether it is at the hearing
pursuant to proposed § 405.1030(b)(1),
or at a later time pursuant to proposed
§ 405.1030(c). Proposed § 405.1030(d)
would provide appellants with an
incentive to submit evidence they wish
to have considered early in the
adjudication process, allow the ALJ to
consider the evidence and effectively
prepare for the hearing, and minimize
any delays in the adjudication process
resulting from the late introduction of
evidence during the hearing process.
Proposed § 405.1030(d) would also
remove the potential incentive to
disregard § 405.1018, and reconcile any
inconsistency in the effect of a late
evidentiary submission on an applicable
adjudication period by incorporating the
§ 405.1018 provisions by reference
rather than establishing a different
standard for evidence submitted during
the course of or after a hearing. We are
proposing at § 423.2030(d) to adopt a
corresponding provision for the effect
on an adjudication time frame when
new evidence is submitted by a
represented enrollee in a standard
appeal, or an unrepresented or
represented enrollee in an expedited
appeal, in accordance with current
§ 423.2018(b) or (c), as applicable.
Continuing a hearing is referenced in
current § 405.1030(c), but is not
otherwise addressed in part 405, subpart
I. We are proposing in § 405.1030(e)(1)
that a hearing may be continued to a
later date and that the notice of the
continued hearing would be sent in
accordance with the proposed
§ 405.1022, except that a waiver of the
notice of hearing may be made in
writing or on the record, and the notice
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of continued hearing would be sent to
the parties and participants who
attended the hearing, and any additional
parties or potential parties or
participants the ALJ determines are
appropriate. The notice requirement
would help ensure that the general
hearing notice requirements are met for
a continued hearing, but allow a waiver
of the notice of hearing to be made in
writing or on the record. We believe the
added option of waiving the notice of
hearing on the record in the context of
a continued hearing would facilitate
scheduling the continued hearing when
all parties and participants who are in
attendance at the hearing agree to the
continued hearing date, or alternatively
agree on the record to the notice being
mailed, transmitted, or served fewer
than 20 calendar days before the
hearing. In addition, proposed
§ 405.1030(e)(1) would only require that
a notice of the continued hearing be sent
to the participants and parties who
attended the hearing, but would provide
the ALJ with the discretion to also send
the notice to additional parties, or
potential parties or participants. We
believe that a notice of the continued
hearing to a party, or potential party or
participant, who did not attend the
hearing is not necessary unless the ALJ
determines otherwise based on the
circumstances of the case. In the event
that the appellant requested the
continuance and an adjudication period
applies to the appeal, we are proposing
in § 405.1030(e)(2) to provide that the
adjudication period would be extended
by the period between the initial
hearing date and the continued hearing
date. We believe an appellant’s request
for a continuance of the hearing is
similar to an appellant’s request to
reschedule a hearing, and if the request
is granted, the adjudication period for
the appellant’s request for hearing
should be adjusted accordingly. We are
proposing at § 423.2030(e) to adopt
corresponding provisions for continued
hearings in part 423, subpart U
proceedings.
On occasion, after a hearing is
conducted, ALJs find that additional
testimony or evidence is necessary to
decide the issues on appeal, or a
procedural matter needs to be
addressed. Current § 405.1030(f) allows
an ALJ to reopen a hearing to receive
new and material evidence pursuant to
§ 405.986, which requires that the
evidence (1) was not available or known
at the time of the hearing, and (2) may
result in a different conclusion.
However, current § 405.1030(f) does not
provide a mechanism to address
procedural matters, or to obtain
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additional information through
evidence or testimony that may have
been available at the time of hearing and
may result in a different outcome but
the importance of which was not
recognized until after a post-hearing
review of the case. We are proposing in
§ 405.1030(f)(1) to remove the ‘‘reopen’’
label and provide for a ‘‘supplemental’’
hearing rather than reopening the
hearing to distinguish it from reopening
a decision and the standards for
reopening a decision. We are also
proposing that a supplemental hearing
may be conducted at the ALJ’s
discretion at any time before the ALJ
mails a notice of decision in order to
receive new and material evidence,
obtain additional testimony, or address
a procedural matter. The ALJ would
determine whether a supplemental
hearing is necessary, and if one is held,
the scope of the supplemental hearing,
including when evidence is presented
and what issues are discussed. In
addition, we are proposing at
§ 405.1030(f)(1) that a notice of the
supplemental hearing be sent in
accordance with § 405.1022 to the
participants and parties who attended
the hearing, but would provide the ALJ
with the discretion to also send the
notice to additional parties, or potential
parties or participants the ALJ
determines are appropriate. Similar to
the proposed notice of a continued
hearing explained above, we believe
that a notice of the supplemental
hearing to a party, or potential party or
participant, who did not attend the
hearing is not necessary unless the ALJ
determines otherwise based on the
circumstances of the case. In the event
that the appellant requested the
supplemental hearing and an
adjudication period applies to the
appeal, we are proposing at
§ 405.1030(f)(2) to provide that the
adjudication period would be extended
by the period between the initial
hearing date and the supplemental
hearing date. We believe an appellant’s
request for a supplemental hearing is
similar to an appellant’s request for a
continuance or to reschedule a hearing,
and if the request is granted, the
adjudication period for the appellant’s
request for hearing should be adjusted
accordingly. We are proposing at
§ 423.2030(f) to adopt corresponding
provisions for supplemental hearings in
part 423, subpart U proceedings.
We are inviting public comments on
these proposals. If you choose to
comment on the proposals in this
section, please include the caption ‘‘ALJ
hearing procedures’’ at the beginning of
your comment.
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o. Issues Before an ALJ or Attorney
Adjudicator (§§ 405.1032 and 423.2032)
Current §§ 405.1032 and 423.2032
address the issues that are before the
ALJ. We are proposing to revise the title
of the section to indicate that the
proposed provision also would apply to
issues before an attorney adjudicator, as
proposed in section II.B above, if an
attorney adjudicator is assigned to an
appeal.
Current § 405.1032(a) states that the
issues before the ALJ include all of the
issues brought out in the initial
determination, redetermination, or
reconsideration that were not decided
entirely in a party’s favor. However,
when a request for hearing involves a
reconsideration of multiple claims and
the appellant does not identify one or
more of the claims that were not
decided entirely in the party’s favor at
initial determination, redetermination,
or reconsideration, it is unclear whether
the ALJ should review all of the claims
that were not decided entirely in the
party’s favor at initial determination,
redetermination, or reconsideration, or
just those claims specified by the
appellant in the request for hearing. An
appellant is required to identify the
dates of service for the claims that it
wishes to appeal in its request for
hearing under § 405.1014, and some
appellants have indicated that they do
not specify a denied claim in a request
for hearing when they agree that the
record does not support coverage of the
claim. To address the ambiguity, and in
the interest of efficiency and
consistency with § 405.1014, we are
proposing in § 405.1032(a) that the
issues before the ALJ or attorney
adjudicator include all the issues for the
claims or appealed matter (for example,
for appeals that do not involve a claim
for items or services furnished to a
beneficiary, such as Medicare
Secondary Payer appeals and
terminations of coverage) specified in
the request for hearing that were
brought out in the initial determination,
redetermination, or reconsideration that
were not decided entirely in a party’s
favor. We are proposing at § 423.2032(a)
to adopt a corresponding revision for
issues in part 423, subpart U
proceedings, except the term claims is
not used because part 423, subpart U
appeals do not involve claims.
Current § 405.1032(a) also notes that if
evidence presented before the hearing
causes the ALJ to question a favorable
portion of the determination, the ALJ
notifies the parties before the hearing
and may consider it an issue at the
hearing. As explained in the 2005
Interim Final Rule (70 FR 11462), this
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provision relates to the favorable
portion of an appealed claim, and that
the favorable issue is a new issue that
must meet the requirements of current
paragraph (b). However, in practice, this
provision has been read to allow
consideration of separate claims that
were decided in a party’s favor at lower
appeal levels in multiple-claim appeals,
and at times read independently from
paragraph (b). To address this
confusion, we are proposing to move
this language in § 405.1032(a) to
proposed § 405.1032(b), with the
revisions discussed below. We are
proposing at § 423.2032(a) and (b) to
adopt corresponding revisions for new
issues in part 423, subpart U
proceedings.
Current § 405.1032(b) allows new
issues to be considered at the hearing if:
(1) the ALJ notifies the parties about the
new issue before the start of the hearing;
(2) the resolution of the new issue could
have a material impact on the claim or
claims that are the subject of the request
for hearing; and (3) its resolution is
permissible under the rules governing
reopening of determinations and
decisions. We are proposing at
§ 405.1032(b) to incorporate these
provisions, with the revisions discussed
below, as well as the language regarding
consideration of favorable issues moved
from current § 405.1032(a), in a revised
structure.
We are proposing in § 405.1032(b)(1)
to address when a new issue may be
considered. Specifically, we are
proposing that the ALJ may only
consider the new issue, including a
favorable portion of a determination on
a claim or appealed matter specified in
the request for hearing, if its resolution
could have a material impact on the
claim or appealed matter, and (1) there
is new or material evidence that was not
available or known at the time of the
determination and which may result in
a different conclusion, or (2) the
evidence that was considered in making
the determination clearly shows on its
face that an obvious error was made at
the time of the determination. This
would consolidate the current
provisions to better convey when a new
issue may be considered, clarify that a
new issue relates to a claim or appealed
matter specified in the request for
hearing, and provide the applicable
standards from the reopening rules
referenced in current
§ 405.1032(b)(1)(ii). We are proposing in
§ 405.1032(b)(1) to continue to provide
that the new issue may be raised by the
ALJ or any party and may include issues
resulting from the participation of CMS,
but correct the language so that it also
references participation of CMS
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contractors. We are proposing at
§ 423.2032(b)(1) to adopt corresponding
revisions for when new issues may be
considered in part 423, subpart U
proceedings.
We are proposing at § 405.1032(b)(2)
to continue to provide that notice of the
new issue must be provided before the
start of the hearing, but would limit the
notice to the parties who were or will
be sent the notice of hearing, rather than
the current standard to notice ‘‘all of the
parties.’’ Because notice of the new
issue may be made in the notice of
hearing or after the notice of hearing,
and parties generally have 10 calendar
days after receipt of the notice of
hearing to submit evidence, we are
proposing at § 405.1032(b)(3) to also
provide that if notice of the new issue
is sent after the notice of hearing, the
parties would have at least 10 calendar
days after receiving the notice of the
new issue to submit evidence regarding
the issue. As provided in proposed
§ 405.1028(a)(2)(ii), the ALJ would then
determine whether the new evidence is
material to the new issue identified by
the ALJ. If an adjudication time frame
applies to the appeal, the adjudication
period would not be affected by the
submission of evidence. Further, we are
proposing at § 405.1032(b)(3) that if the
hearing is conducted before the time to
submit evidence regarding the issue
expires, the record would remain open
until the opportunity to submit
evidence expires to provide the parties
sufficient time to submit evidence
regarding the issue. We are proposing at
§ 423.2032(b)(2) and (b)(3) to adopt
corresponding provisions for providing
notice of new issues to enrollees and an
opportunity to submit evidence, and to
add that an enrollee will have 2
calendar days after receiving notice of
the new issue in an expedited appeal to
submit evidence, which corresponds to
the length of time permitted under
proposed § 423.2018(c) to submit
evidence after receiving a notice of
expedited hearing.
Current § 405.1032(c) states that an
ALJ cannot add any claim, including
one that is related to an issue that is
appropriately before an ALJ, to a
pending appeal unless the claim has
been adjudicated at the lower appeal
levels and all parties are notified of the
new issues before the start of the
hearing. However, in practice, we are
unaware that this provision is used, and
to the extent it may be used, we believe
it would be disruptive to the
adjudication process, result in filing
requirements not being observed, and
risk adjudication of the same claim by
multiple adjudicators. Therefore, we are
proposing to maintain the topic of
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adding claims to a pending appeal, but
replace the language of current
§ 405.1032(c), as explained below.
A reconsideration may be appealed
for an ALJ hearing regardless of the
number of claims involved in the
reconsideration. However, we recognize
that a party may not specify all of the
claims from a reconsideration that he or
she wishes to appeal in the party’s
request for hearing. We are proposing in
§ 405.1032(c)(1) to address this
circumstance by providing that claims
that were not specified in a request for
hearing may only be added to a pending
appeal if the claims were adjudicated in
the same reconsideration that is
appealed in the request for hearing, and
the period to request an ALJ hearing for
that reconsideration has not expired, or
an ALJ or attorney adjudicator extends
the time to request an ALJ hearing on
those claims to be added in accordance
with proposed § 405.1014(e). We believe
that this would result in less disruption
to the adjudication process, greater
adherence to filing requirements, and
reduce the risk of adjudication of the
same claim by multiple adjudicators. To
help ensure that the copy requirement
of proposed § 405.1014(d) is observed,
we are proposing at § 405.1032(c)(2) to
require that before a claim may be
added to a pending appeal, the
appellant must submit evidence that
demonstrates that the information that
constitutes a complete request for
hearing in accordance with
§ 405.1014(b) and other materials
related to the claim that the appellant
seeks to add to the pending appeal were
sent to the other parties to the claim in
accordance with § 405.1014(d). We are
proposing at § 423.2032(c) to adopt a
provision corresponding to proposed
§ 405.1032(c)(1), but we are not
proposing to adopt a provision
corresponding to § 405.1032(c)(2)
because there is no § 423.2014
requirement for an enrollee to send a
copy of his or her request to others.
Current § 405.1032 does not address
issues related to an appeal that involves
a disagreement with how a statistical
sample and/or extrapolation was
conducted. When an appeal involves a
statistical sample and an extrapolation
and the appellant wishes to challenge
how the statistical sample and/or
extrapolation was conducted, as
discussed previously, we are proposing
at § 405.1014(a)(3)(iii) to require the
appellant to assert the reasons the
appellant disagrees with how the
statistical sampling and/or extrapolation
was conducted in the request for
hearing. We are proposing at
§ 405.1032(d)(1) to reinforce this
requirement by excluding issues related
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to how the statistical sample and/or
extrapolation were conducted if the
appellant does not comply with
§ 405.1014(a)(3)(iii). In addition to
reinforcing the proposed requirement at
§ 405.1014(a)(3)(iii), we believe that
excluding the issue is appropriate
because an appellant should reasonably
be aware of whether it disagrees with
how the statistical sampling and/or
extrapolation was conducted at the time
it files a request for hearing, and raising
the issue later in the adjudication
process or at the hearing can cause
significant delays in adjudicating an
appeal because the ALJ may need to
conduct additional fact finding, find it
necessary to request participation of
CMS or one of its contractors, and/or
call expert witnesses to help address the
issue.
Related to the issues that an ALJ must
consider, the 2005 Interim Final Rule
(70 FR 11466) explained that current
§ 405.1064 was added to set forth a
general rule regarding ALJ decisions
that are based on statistical samples
because a decision that is based on only
a portion of a statistical sample does not
accurately reflect the entire record. As
discussed in the 2009 Final Rule (74 FR
65328), current § 405.1064 explains that
when an appeal from the QIC involves
an overpayment, and the QIC used a
statistical sample in reaching its
reconsideration, the ALJ must base his
or her decision on a review of all claims
in the sample. However, while a review
of the claims selected for the sample is
necessary to review issues related to a
contested sample and extrapolation, for
example to determine whether the
sample claims were appropriately
selected for a representative sample of
the universe, current § 405.1064 has
been read more broadly to also require
adjudication of each sample claim,
regardless of whether the sample claim
was adjudicated favorably at lower
appeal levels. We do not believe
adjudicating sample claims that were
decided favorably at lower levels of
appeal, or sample claims that are not
appealed by a party, is necessary to
adjudicate broader issues with how
sampling and extrapolation was
conducted, and the broader reading of
current § 405.1064 results in
unnecessary adjudications of claims that
were not appealed.
To clarify what is at issue and what
must be considered in appeals involving
statistical sampling and extrapolations,
we are proposing to remove current
§ 405.1064, and address the matter in
§ 405.1032(d)(2). We are proposing in
§ 405.1032(d)(2) that if a party asserts a
disagreement with how the statistical
sampling methodology and
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extrapolation were conducted in the
request for hearing, in accordance with
proposed § 405.1014(a)(3)(iii),
§ 405.1032(a) through (c) would apply to
the adjudication of the sample claims.
The result of applying proposed
§ 405.1032(a) and (b) would be that only
the sample units that were specified in
the request for hearing are individually
adjudicated, subject to a new issue
being identified for an appealed claim.
However, proposed § 405.1032(c) would
permit adding sample claims to a
pending appeal if they were adjudicated
in the appealed reconsideration and the
time to request a hearing on the
reconsideration has not expired, or the
ALJ or attorney adjudicator extends the
time to request an ALJ hearing on those
claims in accordance with § 405.1014(e).
To incorporate the principle embodied
in current § 405.1064, we are proposing
in § 405.1032(d)(2) that in deciding
issues related to how a statistical sample
and/or extrapolation was conducted, the
ALJ or attorney adjudicator would base
his or her decision on a review of the
entire sample to the extent appropriate
to decide the issue. We believe this
more clearly conveys the intent of the
rule and recognizes that an individual
adjudication of each claim in the sample
is not always necessary to decide an
issue related to how a statistical sample
and/or extrapolation was conducted,
such as whether there is documentation
so that the sampling frame can be recreated, as required by the Medicare
Program Integrity Manual (Internet-Only
Manual 100–08) (see chapter 8,
§ 8.4.4.4.1). We are not proposing any
corresponding changes in § 423.2030
because statistical sampling and
extrapolation are not currently used for
matters that are subject to part 423,
subpart U proceedings.
We are inviting public comments on
these proposals. If you choose to
comment on the proposals in this
section, please include the caption
‘‘Issues before an ALJ or attorney
adjudicator’’ at the beginning of your
comment.
p. Requesting Information From the QIC
or IRE, and Remanding an Appeal
(§§ 405.1034, 405.1056, 405.1058,
423.2034, 423.2056, and 423.2058)
Current §§ 405.1034 and 423.2034
describe when an ALJ may request
information from, or remand a case to a
QIC or IRE. When the ALJ believes that
the written record is missing
information that is essential to resolving
the issues on appeal and that
information can be provided only by
CMS or its contractors, including an
IRE, or the Part D plan sponsor, current
§§ 405.1034(a) and 423.2034(a) allow an
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ALJ to remand the case to the QIC or IRE
that issued the reconsideration, or retain
jurisdiction of the case and request that
the entity forward the missing
information to the appropriate hearing
office. The 2005 Interim Final Rule (70
FR 11465) explained that in the rare
instance in which the file lacks
necessary technical information that can
only be provided by CMS or its
contractors, it was believed that the
most effective way of completing the
record is to return the case, via remand,
to the contractor; however, the ALJ also
had the option of asking the entity to
forward the missing information to the
ALJ hearing office. In practice,
stakeholders have expressed frustration
and concern with the remand provisions
because in accordance with the
definition of a remand in § 405.902, a
remand vacates the lower level appeal
decision and therefore may require a
QIC or IRE to issue a new
reconsideration, for which the appellant
must submit a new request for hearing,
which causes additional delay in
reaching finality on the disputed claims.
In addition, current §§ 405.1034 and
423.2034 do not address providing
notice of a remand or the effects of a
remand.
To address stakeholders’ concerns
with the current remand provisions, and
areas not addressed in current
§§ 405.1034 and 423.2034, we are
proposing to revise the sections to cover
obtaining information that can be
provided only by CMS or its contractors,
or the Part D plan sponsor, and
establishing new §§ 405.1056 and
405.1058 to address remands to a QIC,
and new §§ 423.2056 and 423.2058 to
address remands to an IRE.
We are proposing in § 405.1034(a) to
maintain the current standards for
requesting information that is missing
from the written record when that
information can be provided only by
CMS or its contractors, but limit the
action to a request for information
directed to the QIC that conducted the
reconsideration or its successor (if a QIC
contract has been awarded to a new
contractor). In addition, we are revising
§ 405.1034(a) to include attorney
adjudicators because attorney
adjudicators would be authorized to
adjudicate appeals, as proposed in
section II.B. Also, while we are
proposing to retain the definition of
‘‘can be provided only by CMS or its
contractors’’ in § 405.1034(a)(2), we are
proposing at § 405.1034(a)(1) to specify
that official copies of redeterminations
and reconsiderations that were
conducted on the appealed claims can
be provided only by CMS or its
contractors. The redetermination and
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reconsideration are important
documents that establish the issues on
appeal, and while the parties often have
copies of them, we believe the record
should include official copies from the
contractors. In addition, we are
proposing at § 405.1034(b) to specify
that the ALJ or attorney adjudicator
would retain jurisdiction of the case,
and the case would remain pending at
OMHA. We are proposing at
§ 423.2034(a) and (b) to adopt
corresponding provisions for when
information may be requested from an
IRE and that jurisdiction is retained at
OMHA in part 423, subpart U
proceedings.
We are proposing in § 405.1034(c) that
the QIC would have 15 calendar days
after receiving the request for
information to furnish the information
or otherwise respond to the request for
information, either directly or through
CMS or another contractor. This
proposal would provide the ALJ or
attorney adjudicator, the QIC, and the
parties with a benchmark for obtaining
the information and determining when
adjudication of the case can resume. We
are proposing in § 405.1034(d) that, if an
adjudication period applies to the
appeal in accordance with § 405.1016,
the adjudication period would be
extended by the period between the date
of the request for information and the
date the QIC responds to the request or
20 calendar days after the date of the
request, whichever is less. We recognize
that other provisions that extend an
applicable adjudication period generally
involve an appellant’s action or
omission that delays adjudicating an
appeal within an applicable time frame,
but we believe that an extension is also
warranted to fully develop the record
when the written record is missing
information that is essential to resolving
the issues on appeal, and that 20
calendar days (5 calendar days for the
request to be received by the QIC and
15 calendar days for the QIC to respond)
is a relatively modest delay in order to
obtain missing information that is
essential to resolving the appeal. We are
proposing at § 423.2034(c) and (d) to
adopt corresponding provisions for the
IRE to furnish the information or
otherwise respond to the request for
information, either directly or through
CMS or the Part D plan sponsor, and the
effect on any applicable adjudication
time frame in part 423, subpart U
proceedings. In addition, we are
proposing at § 423.2034(c) and (d) to
provide for an accelerated response time
frame for expedited appeals because of
the urgency involved. For expedited
appeals, we are proposing that the IRE
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would have 2 calendar days after
receiving a request for information to
furnish the information or otherwise
respond to the request, and the
extension to the adjudication time frame
would be up to 3 calendar days, to allow
for time to transmit the request to the
IRE and for the IRE to respond.
We are proposing to add new
§ 405.1056 to describe when a request
for hearing or request for review of a
QIC dismissal may be remanded, and
new § 405.1058 to describe the effect of
a remand. We are proposing in
§ 405.1056(a)(1) to permit a remand if an
ALJ or attorney adjudicator requests an
official copy of a missing
redetermination or reconsideration for
an appealed claim in accordance with
proposed § 405.1034, and the QIC or
another contractor does not furnish the
copy within the time frame specified in
§ 405.1034. We also are proposing in
§ 405.1056(a)(2) to permit a remand
when the QIC does not furnish a case
file for an appealed reconsideration. The
remand under both provisions would
direct the QIC or other contractor (such
as a Medicare Administrative Contractor
that made the redetermination) to
reconstruct the record or initiate a new
appeal adjudication. We expect this
type of remand to be very rare, but we
believe it is necessary to help ensure a
complete administrative record of the
administrative adjudication of a claim.
To address the possibility that the QIC
or another contractor is able to
reconstruct the record for a remanded
case, we are proposing in
§ 405.1056(a)(3) to provide that in the
situation where a record is
reconstructed by the QIC, the
reconstructed record would be returned
to OMHA, the case would no longer be
remanded and the reconsideration
would no longer be vacated, and if an
adjudication period applies to the case,
the period would be extended by the
time between the date of the remand
and the date the case is returned to
OMHA because OMHA was unable to
adjudicate the appeal between when it
was remanded and when it was
returned to OMHA. This would help
ensure that appellants are not required
to re-start the ALJ hearing or dismissal
review process in the event that the QIC
or another contractor is able to
reconstruct the record. We are
proposing at § 423.2056(a) to adopt
corresponding provisions for remanding
cases in which there is a missing appeal
determination or the IRE is unable to
furnish the case file in part 423, subpart
U proceedings.
On occasion, an ALJ finds that a QIC
issued a reconsideration that addresses
coverage or payment issues related to
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the appealed claim when a
redetermination was required and no
redetermination was conducted, or the
contractor dismissed the request for
redetermination and the appellant
appealed the contractor’s dismissal. In
either circumstance, the reconsideration
was issued in error because the
appellant did not have a right to the
reconsideration in accordance with
current § 405.960, which only provides
a right to a reconsideration when a
redetermination is made by a contractor.
We do not believe that an administrative
error made by the QIC conveys rights
that are not afforded under the rules. We
are proposing in § 405.1056(b) to
address these circumstances so that, if
an ALJ or attorney adjudicator finds that
the QIC issued a reconsideration that
addressed coverage or payment issues
related to the appealed claim and no
redetermination of the claim was made
(if a redetermination was required) or
the request for redetermination was
dismissed (and not vacated), the
reconsideration would be remanded to
the QIC that issued the reconsideration,
or its successor, to re-adjudicate the
request for reconsideration. We again
expect this type of remand to be rare,
but believe it is necessary to correct
administrative errors in the adjudication
process. We are proposing at
§ 423.2056(b) to adopt a corresponding
provision for when an IRE issues a
reconsideration that addresses drug
coverage when no redetermination was
conducted or a request for
redetermination was dismissed and is
appealed to OMHA under part 423,
subpart U.
OMHA ALJs sometimes receive
requests for remands from CMS or a
party because the matter can be resolved
by a CMS contractor if jurisdiction of
the claim is returned to the QIC. Current
§ 405.1034 does not address this type of
request. We are proposing at
§ 405.1056(c)(1) to provide a mechanism
for these remands. Specifically, we are
proposing that at any time prior to an
ALJ or attorney adjudicator issuing a
decision or dismissal, the appellant and
CMS or one of its contractors, may
jointly request a remand of the appeal
to the entity that conducted the
reconsideration. We are proposing that
the request include the reasons why the
appeal should be remanded and
indicate whether remanding the case
would likely resolve the matter in
dispute. Proposed § 405.1056(c)(2)
would allow the ALJ or attorney
adjudicator to determine whether to
grant the request and issue the remand,
based on his or her determination of
whether remanding the case would
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likely resolve the matter in dispute. We
believe this added flexibility would
allow appellants and CMS and its
contractors to expedite resolution of a
disputed claim when there is agreement
to do so. We are proposing at
§ 423.2056(c) to adopt corresponding
provisions for requested remands in part
423, subpart U proceedings.
Current § 405.1034(b) provides that if,
consistent with current § 405.1004(b),
the ALJ determines that a QIC’s
dismissal of a request for
reconsideration was in error, the case
will be remanded to the QIC. We are
proposing at § 405.1056(d) to
incorporate this provision and proposed
§ 423.2056(d) would adopt a
corresponding provision to incorporate
current § 423.2034(b)(1) for remanding
cases in which an IRE’s dismissal of a
request for reconsideration was in error,
in part 423, subpart U proceedings. In
addition, we are proposing at
§ 423.2056(e) to incorporate current
§ 423.2034(b)(2), which provides that if
an enrollee wants evidence of a change
in his or her condition to be considered
in the appeal, the appeal would be
remanded to the IRE for consideration of
the evidence on the change in
condition.
Current § 405.1034(c) provides that
the ALJ remands an appeal to the QIC
that made the reconsideration if the
appellant is entitled to relief pursuant to
42 CFR 426.460(b)(1), 426.488(b), or
426.560(b)(1), and provides that unless
the appellant is entitled to such relief,
the ALJ applies the LCD or NCD in place
on the date the item or service was
provided. We are proposing to
incorporate these provisions at
§ 405.1056(e). We did not propose any
corresponding provision for § 423.2056
because there is not a similar current
provision for part 423, subpart U
proceedings.
As noted above, current § 405.1034
does not address providing a notice of
remand. We are proposing at
§ 405.1056(f) to provide that OMHA
mails or otherwise transmits a written
notice of the remand of the request for
hearing or request for review to all of
the parties who were sent a copy of the
request at their last known address, and
CMS or a contractor that elected to be
a participant to the proceedings or a
party to the hearing. The notice would
state that, as discussed below, there is
a right to request that the Chief ALJ or
a designee review the remand. We
believe this would help ensure that the
parties and CMS and its contractors
receive notice that the remand order has
been issued. We are proposing at
§ 423.2056(f) to adopt a corresponding
provision for a notice of remand in part
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423, subpart U proceedings, except that
only the enrollee receives notice
because only the enrollee is a party, and
CMS, the IRE, and the Part D plan
sponsor only receive notice if they
requested to participate and the request
was granted.
Stakeholders have recounted
instances in which they believe a
remand was not authorized by the
regulations, but were unable to take any
action to correct the perceived error
because a remand is not an appealable
action and current § 405.1034 does not
provide a review mechanism. We do not
believe that remands should be made
appealable actions, but recognize that
stakeholders need a mechanism to
address remands that they believe are
not authorized by the regulation. We are
proposing in § 405.1056(g) to provide a
mechanism to request a review of a
remand by allowing a party or CMS, or
one of its contractors, to file a request
to review a remand with the Chief ALJ
or a designee within 30 calendar days of
receiving a notice of remand. If the
Chief ALJ or designee determines that
the remand is not authorized by
§ 405.1056, the remand order would be
vacated. We are also proposing that the
determination on a request to review a
remand order is binding and not subject
to further review so adjudication of the
appeal can proceed. We are proposing at
§ 423.2056(g) to adopt a corresponding
provision for reviewing a remand in part
423, subpart U proceedings.
Current § 405.1034 does not discuss
the effect of a remand. We are proposing
at § 405.1058, similar to current
§§ 405.1048 and 405.1054 which
describe the effects of a decision and
dismissal, respectively, that a remand of
a request for hearing or request for
review is binding unless it is vacated by
the Chief ALJ or a designee in
accordance with proposed
§ 405.1056(g). We believe the provision
would add clarity for the parties and
other stakeholders on the effect of a
remand order. We are proposing at
§ 423.2058 to adopt a corresponding
provision for the effect of a remand in
part 423, subpart U proceedings.
We are inviting public comments on
these proposals. If you choose to
comment on the proposals in this
section, please include the caption
‘‘Requesting information from the QIC
or IRE, and remanding an appeal’’ at the
beginning of your comment.
q. Description of the ALJ Hearing
Process and Discovery (§§ 405.1036,
405.1037, and 423.2036)
Current §§ 405.1036 and 423.2036
describe the ALJ hearing process,
including the right to appear and
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present evidence, waiving the right to
appear at the hearing, presenting written
statements and oral arguments, waiver
of the adjudication period, what
evidence is admissible at the hearing,
subpoenas, and witnesses at a hearing.
Current § 405.1037 describes the
discovery process in part 405, subpart I
proceedings, which is permitted when
CMS or a contractor elects to be a party
to the ALJ hearing; there is no
corresponding provision for part 423,
subpart U proceedings because CMS,
the IRE, and the Part D plan sponsor
may not be made parties to the hearing.
Current § 405.1036(b)(1) states that a
party may ‘‘send the ALJ’’ a written
statement indicating that he or she does
not wish to appear at the hearing. We
are proposing at § 405.1036(b)(1) to
revise this provision to state that a party
may ‘‘submit to OMHA’’ a written
statement indicating that he or she does
not wish to appear at the hearing. While
the written statement could still be sent
to an ALJ who is assigned to a request
for hearing, we are proposing that the
statement could be submitted to OMHA
(for example, the statement could be
submitted with the request for hearing),
or to the ALJ or attorney adjudicator, as
proposed in section II.B above, after the
request is assigned, to provide more
flexibility and to accommodate
situations where an ALJ or attorney
adjudicator has not been assigned a
request for hearing. We are proposing at
§ 423.2036(b)(1) to adopt a
corresponding revision for submitting a
waiver of the right to appear in part 423,
subpart U proceedings. In addition, we
are proposing at § 423.2036(b)(1)(ii) to
revise the current requirement for the
‘‘ALJ hearing office’’ to document oral
requests to require ‘‘OMHA’’ to
document oral requests, to help ensure
that applicability of the requirement is
clear regardless of whether the oral
request is received by an adjudicator in
an OMHA field office after the appeal is
assigned to an ALJ or attorney
adjudicator, or the oral request is
received in the OMHA central office
before the appeal is assigned to an ALJ
or attorney adjudicator.
As discussed in section III.A.3.h
above, we are proposing to move the
provision for waiving the adjudication
period from current § 405.1036(d) to
proposed § 405.1016(d) because
proposed § 405.1016 addresses
adjudication time frames and we believe
the section is a better place for
discussing adjudication time frame
waivers. To accommodate moving
current § 405.1036(d) to proposed
§ 405.1016(d), we are proposing to redesignate current § 405.1036(g), which
describes witnesses at the hearing, as
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proposed § 405.1036(d) because it more
logically follows the discussion of
presenting witnesses and oral arguments
in current § 405.1036(c). For the same
reasons, we are proposing to move the
provisions at § 423.2036(d) to proposed
§ 423.2016(c), and proposing at
§ 423.2036(d) to re-designate current
§ 423.2036(g) as proposed § 423.2036(d)
to describe witnesses at a hearing in part
423, subpart U proceedings.
Current § 405.1036(f) discusses
subpoenas. Current § 405.1036(f)(5)(i)
states that an ALJ ruling on a subpoena
request is not subject to immediate
review by the Council and may be
reviewed solely during the course of the
Council’s review specified in § 405.1102
(for requests for Council review when
an ALJ issues a decision or dismissal),
§ 405.1104 (for requests for escalation to
the Council), or § 405.1110 (for referrals
for own motion review by the Council).
As discussed in section III.A.3.h.ii
above, we are proposing to remove
section § 405.1104 and relocate
provisions dealing with escalation to the
Council to § 405.1016. Because the
process for requesting escalation to the
Council is now described in proposed
§ 405.1016(e) and (f), we are proposing
at § 405.1036(f)(5)(i) to replace the
reference to § 405.1104 with a reference
to § 405.1016(e) and (f). Current
§ 405.1036(f)(5)(ii) discusses CMS
objections to a ‘‘discovery ruling’’ in the
context of a paragraph on reviewability
of subpoena rulings and current
§ 405.1037(e)(2)(i) separately addresses
CMS objections to a discovery ruling.
We are proposing to revise
§ 405.1036(f)(5)(ii) to replace the current
reference to a ‘‘discovery ruling’’ with
‘‘subpoena ruling’’ so it is consistent
with the topic covered by § 405.1036(f).
No corresponding revisions are
necessary in § 423.2036(f) because there
is no reference to a ‘‘discovery ruling.’’
Current § 405.1037(a)(1) provides that
discovery is permissible only when
CMS or its contractors elects to
participate in an ALJ hearing as a party.
While the intent is generally clear, the
use of ‘‘participate’’ is potentially
confusing given CMS or one of its
contractors can elect to be a participant
in the proceedings, including the
hearing, in accordance with current and
proposed § 405.1010, or elect to be a
party to the hearing in accordance with
current and proposed § 405.1012. We
are proposing to revise § 405.1037(a)(1)
to state that discovery is permissible
only when CMS or its contractor elects
to be a party to an ALJ hearing, in
accordance with proposed § 405.1012.
As noted above, there are no provisions
for discovery in part 423, subpart U
proceedings because CMS, the IRE, or
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the Part D plan sponsor are not
permitted to be a party to the hearing.
Current § 405.1037(e)(1) states that an
ALJ discovery ruling or disclosure
ruling is not subject to immediate
review by the Council and may be
reviewed solely during the course of the
Council’s review specified in § 405.1100
(for Council review in general),
§ 405.1102 (for requests for Council
review when an ALJ issues a decision or
dismissal), § 405.1104 (for requests for
escalation to the Council), or § 405.1110
(for referrals for own motion review by
the Council). For the reasons discussed
above with regard to similar proposed
changes in § 405.1036, we are proposing
at § 405.1037(e)(1) to replace the
reference to § 405.1104 with a reference
to § 405.1016(e) and (f).
Current § 405.1037(f) describes the
effect of discovery on an adjudication
time frame, and provides that the time
frame is tolled until the discovery
dispute is resolved. However, it does
not clearly state when the effect on an
adjudication time frame begins, and
‘‘discovery dispute’’ is not used
elsewhere in the section. In addition,
current § 405.1037(f) does not
contemplate that an adjudication time
frame may not apply (for example, when
the adjudication time frame is waived in
accordance with proposed
§ 405.1016(d)). Therefore, we are
proposing to revise § 405.1037(f) to state
that if an adjudication period applies to
the appeal in accordance with
§ 405.1016, and a party requests
discovery from another party to the
hearing, the adjudication period is
extended for the duration of discovery,
from the date a discovery request is
granted until the date specified for
ending discovery. We believe this
revision would provide a clearer
standard for how an adjudication period
is affected by discovery proceedings.
We are inviting public comments on
these proposals. If you choose to
comment on the proposals in this
section, please include the caption
‘‘Description of the ALJ hearing process
and discovery’’ at the beginning of your
comment.
r. Deciding a Case Without a Hearing
Before an ALJ (§§ 405.1038 and
423.2038)
Current § 405.1038(a) provides
authority to issue a ‘‘wholly favorable’’
decision without a hearing before an
ALJ and without giving the parties prior
notice when the evidence in the hearing
record supports a finding in favor of the
appellant(s) on every issue. We are
proposing in § 405.1038 that if the
evidence in the administrative record
supports a finding in favor of the
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appellant(s) on every issue and no other
party to the appeal is liable for claims
at issue, an ALJ or attorney adjudicator,
as proposed in section II.B above, may
issue a decision without giving the
parties prior notice and without an ALJ
conducting a hearing, unless CMS or a
contractor has elected to be a party to
the hearing in accordance with
§ 405.1012. Proposed § 405.1038(a)
would replace ‘‘wholly favorable’’ with
‘‘fully favorable’’ in the subsection
heading to align with language in
§ 405.1000(g), which addresses a fully
favorable decision being made on the
record, and the nomenclature used in
OMHA’s day to day operations.
Proposed § 405.1038(a) would also
replace ‘‘hearing record’’ with
‘‘administrative record’’ for consistency
with other references to the record, and
replace ‘‘hearing decision’’ with
‘‘decision,’’ for consistency with other
references to a decision. We are
proposing at § 423.2038(a) to adopt
corresponding revisions to align with
language in § 423.2000(g) and to make
references to the record and decisions
consistent in part 423, subpart U
proceedings.
Proposed § 405.1038(a) would also
add two new limitations on issuing a
decision without a hearing before an
ALJ when the evidence in the
administrative record supports a finding
in favor of the appellant(s) on every
issue. First, a decision could not be
issued pursuant to proposed
§ 405.1038(a) if another party to the
appeal is liable for the claims at issue.
Second, a decision could not be issued
pursuant to proposed § 405.1038(a) if
CMS or a contractor elected to be a party
to the hearing in accordance with
§ 405.1012. We recognize that this may
limit decisions that may be issued
pursuant to § 405.1038(a); however, we
believe only a small number of appeals
would be affected, and the new
limitations would mitigate the impact of
such a decision on the other parties to
the appeal and the likelihood of an
appeal to, and remand from, the
Council. No corresponding changes are
proposed in § 423.2038(a) because only
the enrollee is a party in part 423,
subpart U proceedings.
Current § 405.1038(b)(1) permits the
ALJ to decide a case on the record and
not conduct a hearing if: (1) All the
parties indicate in writing that they do
not wish to appear before the ALJ at a
hearing, including a hearing conducted
by telephone or video-teleconferencing,
if available; or (2) an appellant lives
outside of the United States and does
not inform the ALJ that he or she wants
to appear, and there are no other parties
who wish to appear. We are proposing
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to retain this structure in proposed
§ 405.1038(b) but are proposing some
changes. Current § 405.1038(b)(1)(i)
requires all parties to indicate in writing
that they do not wish to appear before
the ALJ at a hearing, and as indicated
above, current § 405.1038(b)(1)(ii) is
contingent on no other parties wishing
to appeal. However, the requirement to
obtain a writing from all parties or
determine the wishes of the nonappellant parties has limited the utility
of the provisions. While all parties have
a right to appear at the hearing, a notice
of hearing is not sent to parties who did
not participate in the reconsideration
and were not found liable for the items
or services at issue after the initial
determination, in accordance with
current § 405.1020(c). We are proposing
at § 405.1038(b)(1)(i) and (b)(1)(ii) to
modify the requirements so writings
only need to be obtained from, or
wishes assessed from, parties who
would be sent a notice of hearing, if a
hearing were to be conducted. Using the
notice of hearing standard protects the
interests of potentially liable parties,
while making the provisions a more
effective option for the efficient
adjudication of appeals. In addition,
proposed § 405.1038(b)(1) would
reinforce that only an ALJ conducts a
hearing by indicating an ALJ or attorney
adjudicator may decide a case on the
record without an ALJ conducting a
hearing. Proposed § 405.1038(b)(1)(ii)
also would indicate that an appellant
who lives outside of the United States
would inform ‘‘OMHA’’ rather than ‘‘the
ALJ’’ that he or she wants to appear at
a hearing before an ALJ, so an appellant
could make that indication before an
appeal is assigned to an ALJ or attorney
adjudicator. We are proposing at
§ 423.2038(b)(1) and (b)(1)(ii) to adopt
corresponding revisions to reinforce that
only an ALJ conducts a hearing and an
enrollee who lives outside of the United
States would inform OMHA that he or
she wishes to appear at a hearing before
an ALJ, but the other changes in
proposed § 405.1038(b) are not made to
§ 423.2038(b) because only the enrollee
is a party in part 423, subpart U
proceedings. We are also proposing in
§ 405.1038(b)(1)(i) to replace
‘‘videoteleconferencing,’’ and in
§ 423.2038(b)(1)(i) to replace ‘‘video
teleconferencing,’’ with ‘‘videoteleconferencing,’’ for consistency with
terminology used in §§ 405.1000,
405.1036, 423.2000, 423.2020, and
423.2036.
On occasion, CMS or one of its
contractors indicates that it believes an
item or service should be covered or
payment made on an appealed claim,
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either before or at a hearing. However,
there are no current provisions that
address this circumstance and it is one
that is ideal for a summary decision in
favor of the parties based on the
statement by CMS or its contractor, in
lieu of a full decision that includes
findings of fact, conclusions of law, and
other decision requirements. We are
proposing to add § 405.1038(c) to
provide a new authority for a stipulated
decision, when CMS or one of its
contractors submits a written statement
or makes an oral statement at a hearing
indicating the item or service should be
covered or paid. In this situation, an ALJ
or attorney adjudicator may issue a
stipulated decision finding in favor of
the appellant or other liable parties on
the basis of the statement, and without
making findings of fact, conclusions of
law, or further explaining the reasons
for the decision. We are proposing at
§ 423.2038(c) to adopt a corresponding
authority for stipulated decisions in part
423, subpart U proceedings.
We are inviting public comments on
these proposals. If you choose to
comment on the proposals in this
section, please include the caption
‘‘Deciding a case without a hearing
before an ALJ’’ at the beginning of your
comment.
s. Prehearing and Posthearing
Conferences (§§ 405.1040 and 423.2040)
Current § 405.1040 discusses
prehearing and posthearing conferences
and permits the ALJ to hold these
conferences to facilitate the hearing or
hearing decision. Current § 405.1040(b)
requires an ALJ to inform ‘‘the parties’’
of the time, place, and purpose of the
prehearing or posthearing conference,
unless a party indicates in writing that
it does not wish to receive a written
notice of the conference. In accordance
with current § 405.1020(c), the notice of
hearing is not sent to a party who did
not participate in the reconsideration
and was not found liable for the services
at issue after the initial determination.
Therefore, we are proposing to modify
§ 405.1040(b) to state that the ALJ would
inform parties who would be or were
sent a notice of hearing in accordance
with § 405.1020(c). In addition, current
§ 405.1040(b) does not provide for
conference notice to be sent to CMS or
a contractor that elected to be a
participant in the proceedings or a party
to the hearing at the time the conference
notice is sent, which has caused
confusion when CMS or a contractor has
made an election before or after a
conference. Therefore, we are proposing
at § 405.1040(b) that a conference notice
be sent to CMS or a contractor that has
elected to be a participant in the
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proceedings or a party to the hearing at
the time the conference notice is sent.
We believe these changes would help
ensure the appropriate parties and
participants are provided with notice of,
and have an opportunity to attend, a
conference. We are proposing at
§ 423.2040(b) and (c) to adopt
corresponding revisions for prehearing
conference notices in non-expedited
and expedited hearings respectively to
state that a conference notice is sent to
CMS, the IRE, and/or the Part D plan
sponsor if the ALJ has granted their
request(s) to be a participant in the
hearing, but we are not proposing to
make other changes in proposed
§ 405.1040(b) to § 423.2040 because only
the enrollee is a party in part 423,
subpart U proceedings. In addition,
because an oral request not to receive a
notice of the conference is permitted for
expedited hearings, we are proposing at
§ 423.2040(d) to revise the requirement
for an ‘‘ALJ hearing office’’ to document
such an oral request to provide more
generally that oral requests must be
documented, which is generally done by
the ALJ’s support staff, rather than other
office staff. In addition, we are
proposing at § 423.2040(d) that
documentation of an oral request not to
receive written notice of the conference
must be added to the administrative
record for consistency in how the record
is referenced.
Current § 405.1040(c) states that, at
the conference, the ALJ may consider
matters in addition to those stated in the
notice of hearing, if the parties consent
in writing. However, OMHA ALJs have
indicated that providing them with the
discretion to delegate conducting a
conference to an attorney would add
efficiency to the process. OMHA
attorneys are licensed attorneys who
support ALJs in evaluating appeals and
preparing appeals for hearing, as well as
drafting decisions, and are well versed
in Medicare coverage and payment
policy, as well as administrative
procedure. Therefore, we are proposing
at § 405.1040(c)(1) that, at the
conference, the ALJ or an OMHA
attorney designated by the ALJ may
conduct the conference, but only the
ALJ conducting a conference may
consider matters in addition to those
stated in the conference notice if the
parties consent to consideration of the
additional matters in writing. This
revision would allow an OMHA
attorney designated by the ALJ assigned
to an appeal to conduct a conference,
but would only allow an ALJ
conducting the conference to consider
matters in addition to those stated in the
conference notice. We believe allowing
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ALJs to delegate the task of conducting
a conference (consistent with the
conference notice stating the purpose of
the conference, in accordance with
§ 405.1040(b)) would provide ALJs with
the flexibility to use OMHA attorneys
and provide ALJs with more time to
devote to hearings and decisions. We
also believe using attorneys to conduct
conferences is appropriate because
conferences are informal proceedings to
facilitate a hearing or decision, and do
not involve taking testimony or
receiving evidence, both of which occur
at the hearing. We also note that the
results of the conference embodied in a
conference order are subject to review
and approval by the ALJ, and ultimately
subject to an objection by the parties,
under the provisions of current
§ 405.1040, which are carried over in
proposed § 405.1040. We are proposing
at § 423.2040(e)(1) to adopt
corresponding revisions for allowing an
ALJ to delegate conducting a conference
to an OMHA attorney, in part 423,
subpart U proceedings.
Current § 405.1040(c) references the
notice of hearing in discussing the
matters that are considered at a
conference. However, a notice of
hearing may not have been issued at the
time a prehearing conference is
scheduled, and the matters being
addressed in the appeal may have
evolved since a notice of hearing was
issued by the time a posthearing
conference is scheduled, resulting in
confusion on the permissible scope of
the matters discussed at a conference.
Therefore, § 405.1040(c)(1) would state
that the matters that are considered at a
conference are those stated in the
conference notice (that is, the purpose
of the conference, as discussed in
current § 405.1040(b)).
Current § 405.1040(c) states that a
record of the conference is made.
However, that requirement has been
read and applied differently by
adjudicators. We are proposing at
§ 405.1040(c)(2) to require that an audio
recording of the conference be made to
establish a consistent standard and
because the audio recording is the most
administratively efficient way to make a
record of the conference. We are
proposing at § 423.2040(e)(1) and (e)(2)
to adopt corresponding revisions to
reference a conference notice and clarify
that an audio recording of the
conference is made in part 423, subpart
U proceedings.
Current § 405.1040(d) requires the ALJ
to issue an order stating all agreements
and actions resulting from the
conference. If the parties do not object,
the agreements and actions become part
of the hearing record and are binding on
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all parties. It does not state to whom a
conference order is issued, and again
broadly references parties in indicating
who may object to the order. In
addition, current § 405.1040(d) does not
establish a time period within which an
objection must be made before the order
becomes part of the record and binding
on the parties. Therefore, we are
proposing to revise § 405.1040(d) to
state that the ALJ issues an order to all
parties and participants who attended
the conference stating all agreements
and actions resulting from the
conference. If a party does not object
within 10 calendar days of receiving the
order, or any additional time granted by
the ALJ, the agreements and actions
become part of the administrative record
and are binding on all parties. Proposed
§ 405.1040(d) would provide that the
order is issued to the parties and
participants who attended the
conference to help ensure the
appropriate parties and participants
receive the order, but as in current
§ 405.1040(d), only a party could object
to the order. Proposed § 405.1040(d)
would also establish that an objection
must be made within 10 calendar days
of receiving the order to establish a
consistent minimum standard for
making objection to a conference order,
but would also provide the ALJ with the
discretion to grant additional time. In
addition, proposed § 405.1040(d) would
replace ‘‘hearing record’’ with
‘‘administrative record’’ for consistency
with other references to the record.
Further, proposed § 405.1040(d) would
continue to only allow the ALJ to issue
a conference order, because we believe
the ALJ should review and approve the
actions and agreements resulting from
the conference, and only an ALJ should
issue an order that would be binding on
the parties, if no objection is made. We
are proposing at § 423.2040(f) to adopt
corresponding revisions to clarify to
whom a conference order is sent and the
time frame to object to the order, and to
specify that agreements and actions
resulting from the conference become
part of the ‘‘administrative record’’
(rather than ‘‘hearing record’’) in part
423, subpart U proceedings. However,
we are proposing to add that an enrollee
must object to a conference order within
1 calendar day of receiving the order for
expedited hearings because of the
abbreviated time frame under which an
expedited hearing and decision must be
completed.
We are inviting public comments on
these proposals. If you choose to
comment on the proposals in this
section, please include the caption
‘‘Prehearing and posthearing
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conferences’’ at the beginning of your
comment.
t. The Administrative Record
(§§ 405.1042 and 423.2042)
The administrative record is HHS’s
record of the administrative
proceedings, and is initially established
by OMHA ALJs and built from the
records of CMS contractors that
adjudicated the claim, or from records
maintained by SSA in certain
circumstances. After adjudication by
OMHA, the Council may include more
documents in the administrative record,
if a request for Council review is filed
or a referral to the Council is made. If
a party then seeks judicial review, the
administrative record is certified and
presented to the Court as the official
agency record of the administrative
proceedings. The record is returned to
the custody of CMS contractors or SSA
after any administrative and judicial
review is complete. Current practices in
creating the administrative record in
accordance with current §§ 405.1042
and 423.2042 vary widely. Given the
importance of the administrative record,
we are proposing to revise §§ 405.1042
and 423.2042 to provide for more
consistency and to clarify its contents
and other administrative matters.
Current § 405.1042(a)(1) provides that
the ALJ makes a complete record of the
evidence, including the hearing
proceedings, if any. However, this
provision has been limiting and causes
confusion in developing procedures to
ensure the completeness of the record
and in bringing consistency to how the
record is structured because individual
adjudicators organize the record
differently. We are proposing to revise
§ 405.1042(a)(1) to require OMHA to
make a complete record of the evidence
and administrative proceedings on the
appealed matter, including any
prehearing and posthearing conferences,
and hearing proceedings that were
conducted. Proposed § 405.1042(a)(1)
would vest OMHA, rather than the ALJ,
with the responsibility of making a
complete record of the evidence and
administrative proceedings in the
appealed matter, including any
prehearing and posthearing conferences
and hearing proceedings. This would
provide OMHA with more discretion to
develop polices and uniform procedures
for constructing the administrative
record, while preserving the role of the
ALJ or attorney adjudicator, as proposed
in section II.B above, to identify the
evidence that was used in making the
determinations below and the evidence
that was used in making his or her
decision. We are proposing at
§ 423.2042(a)(1) to also adopt
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corresponding revisions to indicate
OMHA makes a complete record of the
evidence and administrative
proceedings in the appealed matter in
part 423, subpart U proceedings.
Current § 405.1042(a)(2) discusses
which documents in the record are
marked as exhibits, and provides a nonexhaustive list of documents that are
marked to indicate that they were
considered in making the decisions
under review or the ALJ’s decision. It
further states that in the record, the ALJ
also must discuss any evidence
excluded under § 405.1028 and include
a justification for excluding the
evidence. We are proposing to revise
§ 405.1042(a)(2) to state that the record
would include marked as exhibits, the
appealed determinations, and
documents and other evidence used in
making the appealed determinations
and the ALJ’s or attorney adjudicator’s
decision, including, but not limited to,
claims, medical records, written
statements, certificates, reports,
affidavits, and any other evidence the
ALJ or attorney admits. We are
proposing that attorney adjudicators
could mark exhibits because as
proposed in section II.B, attorney
adjudicators would be adjudicating
requests for hearing and requests for
review of a QIC dismissal, and should
indicate the portions of the record that
he or she considered in making the
decision in the same manner as an ALJ.
Proposed § 405.1042(a)(2) would
continue to require certain evidence to
be marked as exhibits, but would clarify
what would be marked, replacing ‘‘the
documents used in making the decision
under review,’’ with ‘‘the appealed
determinations, and documents and
other evidence used in making the
appealed determinations and the ALJ’s
or attorney adjudicator’s decision.’’ We
believe this would clarify that the
exhibited portion of the record includes,
at minimum, the appealed
determinations, documents and other
evidence used in making the appealed
determinations, and documents and
other evidence used in making the ALJ’s
or attorney adjudicator’s decision. The
illustrative list of documents that may
be marked as exhibits pursuant to the
rule in current § 405.1042(a)(2) would
be incorporated in proposed
§ 405.1042(a)(2) without change. We
also are proposing to clarify at
§ 405.1042(a)(2) that the record would
include any evidence excluded or not
considered by the ALJ or attorney
adjudicator, including, but not limited
to, new evidence submitted by a
provider or supplier, or beneficiary
represented by a provider or supplier,
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for which no good cause was
established, and duplicative evidence
submitted by a party. All evidence
presented should be included in the
record, even if excluded from
consideration, in order to help ensure a
complete record of the evidence.
However, such excluded evidence
would not be marked as an exhibit
because the evidence was not
considered in making the ALJ’s or
attorney adjudicator’s decision. We are
proposing at § 423.2042(a)(2) to adopt
corresponding revisions to clarify what
would be exhibited in part 423, subpart
U proceedings, except the reference to
new evidence submitted by a provider
or supplier, or beneficiary represented
by a provider or supplier, for which no
good cause was established as an
example of evidence excluded or not
considered by the ALJ or attorney
adjudicator, because there is no such
limitation on new evidence in part 423,
subpart U proceedings.
As stated previously, current
§ 405.1042(a)(2) includes requirements
to discuss any evidence excluded under
current § 405.1028 and include a
justification for excluding the evidence.
We are proposing in § 405.1042(a)(2) to
remove these requirements. We believe
the requirement to justify excluding the
evidence is not necessary and is in
tension with the requirement for a
provider or supplier, or beneficiary
represented by a provider or supplier, to
establish good cause for submitting new
evidence before it may be considered.
Section 1869(b)(3) of the Act establishes
a general prohibition on new evidence
that must be overcome, and proposed
§ 405.1028 would implement the statute
by requiring the party to explain why
the evidence was not submitted prior to
the QIC reconsideration, and the ALJ or
attorney adjudicator to make a finding
of good cause to admit the evidence. In
place of the current § 405.1042(a)(2)
requirement, as we discuss later, we are
proposing at § 405.1046(a)(2)(ii) to
require that if new evidence is
submitted for the first time at the
OMHA level and subject to a good cause
determination pursuant to proposed
§ 405.1028, the new evidence and good
cause determination would be discussed
in the decision. We believe the decision
is the appropriate place to discuss the
new evidence and document the good
cause determination, and the discussion
should focus on the good cause
determination required by proposed
§ 405.1028, regardless of whether good
cause was found. We are not proposing
any corresponding changes to
§ 423.2042 because there is no provision
equivalent to the current
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§ 405.1042(a)(2) requirement to discuss
any excluded evidence.
Current § 405.1042(a)(3) provides that
a party may review the record ‘‘at the
hearing,’’ or if a hearing is not held, at
any time before the ALJ’s notice of
decision is issued. However, this is
rarely done in practice. More often, a
party requests a copy of the record prior
to the hearing, in accordance with
current § 405.1042(b). We are proposing
to revise § 405.1042(a)(3) to state that a
party may request and review the record
prior to or at the hearing, or if a hearing
is not held, at any time before the notice
of decision is issued. This revision
would allow a party to request and
review a copy of the record ‘‘prior to or
at the hearing’’ to more accurately
reflect the practices of parties. In
addition, proposed § 405.1042(a)(3)
would remove the reference to an
‘‘ALJ’s’’ decision in explaining that if a
hearing is not held, a party may request
and review the record at any time before
the notice of decision is issued, because
in that circumstance an ALJ or attorney
adjudicator, as proposed in section II.B,
may issue the decision. We are
proposing at § 423.2042(a)(3) to adopt
corresponding revisions for part 423,
subpart U proceedings.
Current § 405.1042(a)(4) provides for
the complete record, including any
recording of the hearing, to be
forwarded to the Council when a
request for review is filed or the case is
escalated to the Council. However, in
noting that the record includes
recordings, only a recording of the
hearing is mentioned. We are proposing
at § 405.1042(a)(4) to add that the record
includes recordings of prehearing and
posthearing conferences in addition to
the hearing recordings, to reinforce that
recordings of conferences are part of the
complete record. We are proposing at
§ 423.2042(a)(4) to adopt corresponding
revisions for part 423, subpart U
proceedings.
Current § 405.1042(b)(1) describes
how a party may request and receive
copies of the record from the ALJ.
However, after a case is adjudicated,
OMHA releases custody of the record
and forwards it to a CMS contractor or
SSA, and the record may go on to the
Council for another administrative
proceeding. This results in confusion for
parties when they request a copy of the
record and OMHA is unable to provide
it. We are proposing at § 405.1042(b)(1)
that a party may request and receive a
copy of the record from OMHA while an
appeal is pending at OMHA. We also are
proposing at § 405.1042(b)(1) to replace
the reference to an ‘‘exhibit list’’ with a
reference to ‘‘any index of the
administrative record’’ to provide
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greater flexibility in developing a
consistent structure for the
administrative record. We also are
proposing to change the parallel
reference to ‘‘the exhibits list’’ in
§ 405.1118 to ‘‘any index of the
administrative record.’’ In addition,
proposed § 405.1042(b)(1) would
replace the reference to a ‘‘tape’’ of the
oral proceeding with an ‘‘audio
recording’’ of the oral proceeding
because tapes are no longer used and a
more general reference would
accommodate future changes in
recording formats. We also are
proposing to replace a parallel reference
at § 405.1118 to a copy of the ‘‘tape’’ of
the oral proceedings with a copy of the
‘‘audio recording’’ of the oral
proceedings. We are proposing at
§§ 423.2042(b)(1) and 423.2118 to adopt
corresponding revisions for part 423,
subpart U proceedings, but note that
current § 423.2118 refers to a ‘‘CD’’ of
the oral proceedings.
Current § 405.1042(b)(2) provides that
if a party requests all or part of the
record from an ALJ and an opportunity
to comment on the record, the time
beginning with the ALJ’s receipt of the
request through the expiration of the
time granted for the party’s response
does not count toward the 90 calendar
day adjudication period. We are
proposing to revise § 405.1042(b)(2) to
state, if a party requests a copy of all or
part of the record from OMHA or the
ALJ or attorney adjudicator and an
opportunity to comment on the record,
any adjudication period that applies in
accordance with § 405.1016 is extended
by the time beginning with the receipt
of the request through the expiration of
the time granted for the party’s
response. This proposed revision would
clarify that a party may request a ‘‘copy
of’’ all or part of the record, and would
add that the request may be made to
OMHA, or the ALJ or attorney
adjudicator, because a party may request
a copy of the record before it is assigned
to an ALJ or attorney adjudicator. In
addition, proposed § 405.1042(b)(2)
would revise the discussion of the effect
of requesting an opportunity to
comment on the record on an
adjudication period to remove the
specific reference to a 90 calendar day
adjudication period, because in
accordance with proposed § 405.1016,
an adjudication period may be 90 or 180
calendar days, or alternatively may be
waived by the appellant and therefore
not apply. We are proposing at
§ 423.2042(b)(2) to adopt corresponding
revisions for part 423, subpart U
proceedings.
Current § 405.1042 does not address
the circumstance in which a party
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requests a copy of the record but is not
entitled to receive some of the
documents in the record. For example,
when an appeal involves multiple
beneficiaries and one beneficiary
requests a copy of the record, the
records related to other beneficiaries
may not be released to the requesting
beneficiary unless he or she obtains
consent from the other beneficiaries to
release the records that pertain to them.
Proposed § 405.1042(b)(3) would
address the possibility that a party
requesting a copy of the record is not
entitled to receive the entire record.
Specifically, we are proposing in
§ 405.1042(b)(3) that if a party requests
a copy of all or part of the record and
the record, including any audio
recordings, contains information
pertaining to an individual that the
requesting party is not entitled to
receive (for example, personally
identifiable information or protected
health information), those portions of
the record would not be furnished
unless the requesting party obtains
consent from the individual. For
example, if a beneficiary requests a copy
of the record for an appeal involving
multiple beneficiaries, the portions of
the record pertaining to the other
beneficiaries would not be furnished to
the requesting beneficiary unless he or
she obtains consent from the other
beneficiaries. We believe proposed
§ 405.1042(b)(3) would help ensure that
parties are aware that they may not be
entitled to receive all portions of the
record. We are proposing at
§ 423.2042(b)(3) to adopt corresponding
revisions for part 423, subpart U
proceedings.
We are inviting public comments on
these proposals. If you choose to
comment on the proposals in this
section, please include the caption ‘‘The
administrative record’’ at the beginning
of your comment.
u. Consolidated Proceedings
(§§ 405.1044 and 423.2044)
Current §§ 405.1044 and 423.2044
explain that a consolidated hearing may
be held at the request of an appellant or
on the ALJ’s own motion, if one or more
of the issues to be considered at the
hearing are the same issues that are
involved in another request for hearing
or hearings pending before the same
ALJ, and CMS is notified of an ALJ’s
intention to conduct a consolidated
hearing. If a consolidated hearing is
conducted, current §§ 405.1044 and
423.2044 further provide that the ALJ
may make a consolidated decision and
record for the claims involved in the
consolidated hearing, or may make a
separate decision and record for each
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claim involved in the consolidated
hearing. This authority is useful in
allowing an ALJ and the appellant to
conduct a single proceeding on multiple
appealed claims or other determinations
that are before the ALJ, reducing time
and expense for the appellant and the
government to resolve the appealed
matter. However, the current provisions
have caused confusion, and have been
limiting in circumstances in which no
hearing is conducted.
Current § 405.1044 uses the terms
‘‘requests for hearing,’’ ‘‘cases,’’ and
‘‘claims’’ interchangeably, which has
resulted in confusion because an appeal,
or ‘‘case,’’ before an ALJ may involve
multiple requests for hearing, if an
appellant’s requests were combined into
one appeal for administrative efficiency
prior to being assigned to the ALJ. In
addition, a request for hearing may
involve one or more claims. We are
proposing in § 405.1044 to use the term
‘‘appeal’’ to specify that appeals may be
consolidated for hearing, and a single
decision and record may be made for
consolidated appeals. We are proposing
to use ‘‘appeal’’ because an appeal is
assigned a unique ALJ appeal number,
for which a unique decision and record
is made. We also are proposing to move
current § 405.1044(b) to new subsection
(a)(2), and to also replace the term
‘‘combined’’ with ‘‘consolidated’’ for
consistent use in terminology. Further,
we are proposing at § 423.2044 to adopt
corresponding revisions to use
consistent terminology in part 423,
subpart U proceedings.
Current § 405.1044(a) through (d)
describes when a consolidated hearing
may be conducted, the effect on an
adjudication period that applies to the
appeal, and providing notice of the
consolidated hearing to CMS. Proposed
§ 405.1044(a) would incorporate current
§ 405.1044(a) through (c) to combine the
provisions related to a consolidated
hearing. In addition, proposed
§ 405.1044(a)(4) would replace the
current requirement to notify CMS that
a consolidated hearing will be
conducted in current § 405.1044(d) with
a requirement to include notice of the
consolidated hearing in the notice of
hearing issued in accordance with
§§ 405.1020 and 405.1022. This would
help ensure notice is provided to the
parties and CMS, as well as its
contractors, in a consistent manner, and
reduce administrative burden on ALJs
and their staff by combining that notice
into the existing notice of hearing. We
are proposing at § 423.2044(a) to adopt
corresponding revisions for part 423,
subpart U proceedings.
Current § 405.1044(e) explains that
when a consolidated hearing is
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conducted, the ALJ may consolidate the
record and issue a consolidated
decision, or the ALJ may maintain
separate records and issue separate
decisions on each claim. It also states
that the ALJ ensures that any evidence
that is common to all claims and
material to the common issue to be
decided is included in the consolidated
record or each individual record, as
applicable. However, there has been
confusion on whether separate records
may be maintained and a consolidated
decision can be issued, as well as what
must be included with the records when
separate records are maintained.
Proposed § 405.1044(b) would
incorporate some of current
§ 405.1044(e) and add provisions for
making a consolidated record and
decision. We are proposing at
§ 405.1044(b)(1) that if the ALJ decides
to hold a consolidated hearing, he or she
may make either a consolidated
decision and record, or a separate
decision and record on each appeal.
This proposed revision would maintain
the current option to make a
consolidated record and decision, or
maintain separate records and issue
separate decisions, but restructures the
provision to highlight that these are two
mutually exclusive options. This
proposal is important because issuing a
consolidated decision without also
consolidating the record, or issuing
separate decisions when a record has
been consolidated, complicates
effectuating a decision and further
reviews of the appeal(s). We are
proposing in § 405.1044(b)(2) that, if a
separate decision and record on each
appeal is made, the ALJ is responsible
for making sure that any evidence that
is common to all appeals and material
to the common issue to be decided, and
audio recordings of any conferences that
were conducted and the consolidated
hearing are included in each individual
administrative record. Proposed
§ 405.1044(b)(2) would address the
confusion that sometimes results in a
copy of the audio recording of a
consolidated hearing not being included
in the administrative records of each
constituent appeal when separate
records are maintained, by clarifying
that if a separate decision and record is
made, audio recordings of any
conferences that were conducted and
the consolidated hearing are included in
each individual record. This proposal is
important because the record for each
individual appeal must be complete. We
are proposing at § 423.2044(b)(1) and
(b)(2) to adopt corresponding revisions
for part 423, subpart U proceedings.
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Current § 405.1044 does not
contemplate a consolidated record and
decision unless a consolidated hearing
was conducted, which is limiting when
multiple appeals for an appellant can be
consolidated in a decision issued on the
record without a hearing. We are
proposing to add § 405.1044(b)(3),
which would provide that, if a hearing
would not be conducted for multiple
appeals that are before the same ALJ or
attorney adjudicator as proposed in
section II.B, and the appeals involve one
or more of the same issues, the ALJ or
attorney adjudicator may make a
consolidated decision and record at the
request of the appellant or on the ALJ’s
or attorney adjudicator’s own motion.
This would provide authority for an ALJ
or attorney adjudicator to make a
consolidated decision and record on the
same basis that a consolidated hearing
may be conducted. We believe this
authority would add efficiency to the
adjudication process when multiple
appeals pending before the same
adjudicator can be decided without
conducting a hearing. We are proposing
at § 423.2044(b)(3) to adopt a
corresponding provision for part 423,
subpart U proceedings.
Current § 405.1044 also does not
clearly address consolidating hearings
for multiple appellants, including
situations in which a beneficiary files a
request for hearing on the same claim
appealed by a provider or supplier, and
the provider or supplier has other
pending appeals that could be
consolidated pursuant to current
§ 405.1044. The general practice is that
a consolidated hearing is conducted for
the appeals of a single appellant. This
is supported by the reference to ‘‘an’’
appellant in current § 405.1044(b), and
helps ensure the hearing and record is
limited to protected information that the
appellant is authorized to receive.
Therefore, we are proposing to add
§ 405.1044(c) to provide that
consolidated proceedings may only be
conducted for appeals filed by the same
appellant, unless multiple appellants
aggregated claims to meet the amount in
controversy requirement in accordance
with § 405.1006, and the beneficiaries
whose claims are at issue have all
authorized disclosure of their protected
information to the other parties and any
participants. This would help ensure
that beneficiary information is protected
from disclosure to parties who are not
authorized to receive it, including when
a beneficiary requests a hearing for the
same claim that has been appealed by a
provider or supplier, and appeals of
other beneficiaries’ claims filed by the
provider or supplier are also pending
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before the same ALJ or attorney
adjudicator. We are proposing at
§ 423.2044(c) to adopt a corresponding
provision for part 423, subpart U
proceedings.
We are inviting public comments on
these proposals. If you choose to
comment on the proposals in this
section, please include the caption
‘‘Consolidated proceedings’’ at the
beginning of your comment.
v. Notice of Decision and Effect of an
ALJ’s or Attorney Adjudicator’s
Decision (§§ 405.1046, 405.1048,
423.2046, and 423.2048)
Current §§ 405.1046 and 423.2046
describe the requirements for a decision
and providing notice of the decision, the
content of the notice, the limitation on
a decision that addresses the amount of
payment for an item or a service, the
timing of the decision, and
recommended decisions. Current
§§ 405.1048 and 423.2048 describe the
effects of an ALJ’s decision. However,
the current sections only apply to a
decision on a request for hearing,
leaving ambiguities when issuing a
decision on a request for review of a QIC
or IRE dismissal. We are proposing to
consolidate the provisions of each
section that apply to a decision on a
request for hearing under proposed
§§ 405.1046(a), 405.1048(a), 423.2046(a)
and 423.2048(a), with further revisions
discussed below, and introduce new
§§ 405.1046(b), 405.1048(b), 423.2046(b)
and 423.2048(b) to address a decision
on a request for review of a QIC or IRE
dismissal, as well as to revise the titles
and provisions of the sections to expand
their coverage to include decisions by
attorney adjudicators, as proposed in
II.B above. We also are proposing to
remove current § 405.1046(d), which
addresses the timing of a decision on a
request for hearing because it is
redundant with § 405.1016 and could
lead to confusion if a different
adjudication period applies, such as a
180-calendar day period for an escalated
request for QIC reconsideration, or if no
adjudication period applies, such as
when the period is waived by the
appellant. Similarly, we are proposing
to remove current §§ 423.2046(a)(1) and
(d) because the adjudication time frames
discussed in the provisions are
redundant with provisions in proposed
§ 423.2016. In addition, we are
proposing to re-designate current
§§ 405.1046(e) and 423.2046(e), as
proposed §§ 405.1046(c) and
423.2046(c) respectively, to reflect the
revised structure of proposed
§§ 405.1046 and 423.2046.
Current § 405.1046 states that an ALJ
will issue a decision unless a request for
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hearing is dismissed. We are proposing
to revise § 405.1046(a) to state that an
ALJ or attorney adjudicator would issue
a decision unless the request for hearing
is dismissed or remanded in order to
accommodate those situations where the
ALJ or attorney adjudicator remands a
case to the QIC. There has been
confusion regarding the content
requirements of the decision itself, as
well as whether the findings or
conclusions in a QIC reconsideration or
the arguments of the parties may be
referenced or adopted in the decision by
reference. We believe that while the
issues that are addressed in a decision
are guided by the reconsideration, as
well as the initial determination and
redetermination, and a party may
present arguments in a framework that
reflects recommended findings and
conclusions, the concept of a de novo
review requires an ALJ or attorney
adjudicator to make independent
findings and conclusions. To address
this confusion, we are proposing in
§ 405.1046(a) to require that the
decision include independent findings
and conclusions to clarify that the ALJ
or attorney adjudicator must make
independent findings and conclusions,
and may not merely incorporate the
findings and conclusions offered by
others, though the ALJ or attorney
adjudicator may ultimately make the
same findings and conclusions. As
discussed in and for the reasons stated
in section III.A.3.t above, proposed
§ 405.1046(a)(2)(ii) would also require
that if new evidence was submitted for
the first time at the OMHA level and
subject to a good cause determination
pursuant to proposed § 405.1028, the
new evidence and good cause
determination would be discussed in
the decision. We are proposing at
§ 423.2046(a) to adopt corresponding
revisions for decisions on requests for
hearing under part 423, subpart U,
except the proposals related to
discussing new evidence and good
cause determinations related to new
evidence because there are no current
requirements to establish good cause for
submitting new evidence in part 423,
subpart U proceedings.
Current § 405.1046(a) requires that a
decision be mailed. As OMHA
transitions to a fully electronic case
processing and adjudication
environment, new options for
transmitting a decision to the parties
and CMS contractors may become
available, such as through secure portals
for parties or through inter-system
transfers for CMS contractors. We are
proposing in § 405.1046(a) to revise the
requirement that a decision be mailed to
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state that OMHA ‘‘mails or otherwise
transmits a copy of the decision,’’ to
allow for additional options to transmit
the decision as technologies develop.
We are proposing to revise § 423.2046(a)
to adopt a corresponding revision for
sending a decision under part 423,
subpart U.
Current § 405.1046(a) also requires
that a copy of the decision be sent to the
QIC that issued the reconsideration.
However, if the decision is issued
pursuant to escalation of a request for a
reconsideration, no reconsideration was
issued. To address this circumstance,
we are proposing in § 405.1046(a) that
the decision would be issued to the QIC
that issued the reconsideration or from
which the appeal was escalated. In
addition, we are proposing in
§ 405.1046(a) to replace
‘‘reconsideration determination’’ with
‘‘reconsideration’’ for consistency in
referencing the QIC’s action. Current
§ 405.1046(a) also requires that a copy of
the decision be sent to the contractor
that made the initial determination.
However, this requirement adds to the
administrative burden on OMHA and
we believe is unnecessary in light of the
requirement that a copy of the decision
be sent to the QIC and the original
decision is forwarded as part of the
administrative record to another CMS
contractor to effectuate the decision.
Thus, we are proposing in § 405.1046(a)
to remove the requirement to send a
copy of the decision to the contractor
that issued the initial determination. In
addition, we are proposing in
§ 423.2046(a) to replace
‘‘reconsideration determination’’ with
‘‘reconsideration’’ for consistency in
referencing the IRE’s action in part 423,
subpart U proceedings, but we are not
proposing to incorporate other changes
proposed for § 405.1046(a) in proposed
§ 423.2046(a) because: (1) escalation is
not available in part 423, subpart U
proceedings; and (2) the Part D plan
sponsor, which makes the initial
coverage determination, has an interest
in receiving and reviewing ALJ and
attorney adjudicator decisions related to
an enrollee’s appeal of drug coverage.
As discussed above, we are proposing
to revise § 405.1046(b) to explain the
process for making a decision on a
request for review of a QIC dismissal. In
accordance with proposed § 405.1004,
we are proposing in § 405.1046(b)(1)
that unless the ALJ or attorney
adjudicator dismisses the request for
review of a QIC’s dismissal or the QIC’s
dismissal is vacated and remanded, the
ALJ or attorney adjudicator issues a
written decision affirming the QIC’s
dismissal. We are proposing in
§ 405.1046(b)(1) that OMHA would mail
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or otherwise transmit a copy of the
decision to all the parties that received
a copy of the QIC’s dismissal because
we believe that the QIC would
appropriately identify the parties who
have an interest in the dismissal, and
that notice of the decision on a request
for review of a QIC dismissal to any
additional parties is unnecessary. We
also believe that notice to the QIC is not
necessary when its dismissal is affirmed
because it has no further obligation to
take action on the request for
reconsideration that it dismissed. We
are proposing in § 405.1046(b)(2)(i) that
the decision affirming a QIC dismissal
must describe the specific reasons for
the determination, including a summary
of the evidence considered and
applicable authorities, but are not
proposing to require a summary of
clinical or scientific evidence because
such evidence is not used in making a
decision on a request for a review of a
QIC dismissal. In addition, we are
proposing that § 405.1046(b)(2)(ii) and
(iii) would explain that the notice of
decision would describe the procedures
for obtaining additional information
concerning the decision, and would
provide notification that the decision is
binding and not subject to further
review unless the decision is reopened
and revised by the ALJ or attorney
adjudicator. We are proposing to revise
§ 423.2046(b) to adopt corresponding
provisions for a decision on requests for
review of an IRE dismissal under part
423, subpart U, except that the notice of
decision will only be sent to the
enrollee because only the enrollee is a
party.
We are proposing to revise the title of
current § 405.1048 to read ‘‘The effect of
an ALJ’s or attorney adjudicator’s
decision’’ and to replace the current
introductory statement in § 405.1048(a)
that ‘‘The decision of the ALJ is binding
on all parties to the hearing’’ with ‘‘The
decision of the ALJ or attorney
adjudicator is binding on all parties’’ to
make the subsection applicable to
decisions by attorney adjudicators and
because the parties are parties to the
decision regardless of whether a hearing
was conducted. We also are proposing
in § 405.1048(b) that the decision of the
ALJ or attorney adjudicator on a request
for review of a QIC dismissal is binding
on all parties unless the decision is
reopened and revised by the ALJ or
attorney adjudicator under the
procedures explained in § 405.980. We
are proposing to revise § 423.2048 to
adopt corresponding provisions for the
effects of ALJ and attorney adjudicator
decisions under part 423, subpart U.
We are inviting public comments on
these proposals. If you choose to
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43843
comment on the proposals in this
section, please include the caption
‘‘Notice of decision and effect of an
ALJ’s or attorney adjudicator’s decision’’
at the beginning of your comment.
w. Removal of a Hearing Request From
an ALJ to the Council (§§ 405.1050 and
423.2050)
Current §§ 405.1050 and 423.2050
explain the process for the Council to
assume responsibility for holding a
hearing if a request for hearing is
pending before an ALJ. We are
proposing to replace ‘‘an ALJ’’ with
‘‘OMHA’’ in the section title, and to
replace ‘‘pending before an ALJ’’ with
‘‘pending before OMHA,’’ and ‘‘the ALJ
send’’ with ‘‘OMHA send’’ in the
section text. In accordance with section
II.B above, these proposed revisions
would provide that a request for hearing
may be removed to the Council
regardless of whether the request is
pending before an ALJ or an attorney
adjudicator. We are not proposing to
replace the last instance of ‘‘ALJ’’ in the
section text because it refers specifically
to hearings conducted by an ALJ.
We are inviting public comments on
these proposals. If you choose to
comment on the proposals in this
section, please include the caption
‘‘Removal of a hearing request from an
ALJ to the Council’’ at the beginning of
your comment.
x. Dismissal of a Request for Hearing or
Request for Review and Effect of a
Dismissal of a Request for Hearing or
Request for Review (§§ 405.1052,
405.1054, 423.2052 and 423.2054)
Current §§ 405.1052 and 423.2052
describe the circumstances in which a
request for hearing may be dismissed
and the requirements for a notice of
dismissal, and current §§ 405.1054 and
423.2054 describe the effect of a
dismissal of a request for hearing.
However, both current sections apply to
a dismissal of a request for hearing,
leaving ambiguities when issuing a
dismissal of a request for review of a
QIC or IRE dismissal. We are proposing
to maintain the provisions of each
section that apply to a dismissal of a
request for hearing in proposed
§§ 405.1052(a), 405.1054(a), 423.2052(a)
and 423.2054(a), with further revisions
discussed below, and to introduce new
§§ 405.1052(b), 405.1054(b), 423.2052(b)
and 423.2054(b) to address a dismissal
of a request for review of a QIC or IRE
dismissal. However, we are proposing to
re-designate and revise §§ 405.1052(a)(1)
and 423.2052(a)(1), as discussed below,
and re-designate the remaining
paragraphs in §§ 405.1052(a) and
423.2052(a) accordingly. We are also
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proposing to remove the introductory
language to current §§ 405.1052 and
423.2052 because it is unnecessary to
state that a dismissal of a request for
hearing is in accordance with the
provisions of the section, as the
provisions are themselves binding
authority and state in full when a
request for hearing may be dismissed. In
addition, we are proposing to revise the
titles of the sections to expand their
coverage to include dismissals of
requests to review a QIC or IRE
dismissal. Furthermore, we are
proposing to re-designate and revise
current §§ 405.1052(b) and 423.2052(b),
which describe notices of dismissal, as
proposed §§ 405.1052(d) and
423.2052(d) respectively, to reflect the
revised structure of proposed
§§ 405.1052 and 423.2052. We also are
proposing to remove current
§ 423.2052(a)(8) and (c) because current
§ 423.2052(a)(8) restates current
§ 423.1972(c)(1), which already provides
that a request for hearing will be
dismissed if the request itself shows that
the amount in controversy is not met,
and current § 423.2052(c) restates
current § 423.1972(c)(2), which already
provides that if after a hearing is
initiated, the ALJ finds that the amount
in controversy is not met, the ALJ
discontinues the hearing and does not
rule on the substantive issues raised in
the appeal. We note that a dismissal
would be warranted in these
circumstances pursuant to current
§ 423.2052(a)(3), which is carried over
as proposed § 423.2052(a)(2) because the
enrollee does not have a right to a
hearing if the amount in controversy is
not met.
We are proposing to re-designate and
revise current §§ 405.1052(a)(1) and
423.2052(a)(1) as proposed
§§ 405.1052(c) and 423.2052(c) to
separately address dismissals based on
a party’s withdrawal. We are proposing
in §§ 405.1052(c) and 423.2052(c) to
include withdrawals of requests to
review a QIC dismissal because we also
propose to add provisions to address
other dismissals of those requests at
§§ 405.1052(b) and 423.2052(b). We also
are proposing that an ALJ or attorney
adjudicator may dismiss a request for
review of a QIC dismissal based on a
party’s withdrawal of his or her request
because as proposed in section II.B
above, both ALJs and attorney
adjudicators would be able to adjudicate
requests to review a QIC dismissal. In
addition, we are proposing that an ALJ
or attorney adjudicator may dismiss a
request for hearing based on a party’s
withdrawal of his or her request. As
discussed in section II.B above, we
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believe that well-trained attorneys can
efficiently perform a review of these
requests and issue dismissals. We
believe using attorney adjudicators to
the maximum extent possible would
help OMHA be more responsive to
appellants and allow ALJs to focus on
conducting hearings and issuing
decisions. We also are proposing to
revise the language in current
§§ 405.1052(a)(1) and 423.2052(a)(1) (as
redesignated in proposed §§ 405.1052(c)
and 423.2052(c)) to (1) replace ‘‘notice
of the hearing decision’’ with ‘‘notice of
the decision, dismissal or remand’’ to
reflect that a decision may be issued
without a hearing, and to reflect other
possible outcomes of the proceeding
(dismissal and remand), and (2) to
clarify that a request to withdraw a
request for hearing may be made orally
at a hearing before the ALJ because only
an ALJ may conduct a hearing.
Current § 405.1052(a)(2) describes
three possible alternatives for
dismissing a request for hearing when
the party that requested the hearing, or
the party’s representative, does not
appear at the time and place set for the
hearing. The current alternatives have
caused confusion for appellants in
understanding whether they are
required to submit a statement
explaining a failure to appear. Further,
current provisions do not require
evidence in the record to document an
appellant was aware of the time and
place of the hearing, and this has
resulted in remands from the Council.
We are proposing to simplify the
provision to provide two alternatives,
and to require that contact has been
made with an appellant and
documented, or an opportunity to
provide an explanation for failing to
appear has been provided before a
request for hearing is dismissed for
failing to appear at the hearing. We are
proposing at § 405.1052(a)(1)(i) to set
forth the first alternative which would
provide that a request for hearing may
be dismissed if the party that filed the
request was notified before the time set
for hearing that the request for hearing
might be dismissed for failure to appear,
the record contains documentation that
the party acknowledged the notice of
hearing, and the party does not contact
the ALJ within 10 calendar days after
the hearing or does contact the ALJ but
does not provide good cause for not
appearing. We are proposing at
§ 405.1052(a)(1)(ii) to set forth the
second alternative which would provide
that a request for hearing may be
dismissed if the record does not contain
documentation that the party
acknowledged the notice of hearing, but
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the ALJ sends a notice to the party at his
or her last known address asking why
the party did not appear, and the party
does not respond to the ALJ’s notice
within 10 calendar days after receiving
the notice or does respond but does not
provide good cause for not appearing. In
either circumstance, we are maintaining
in proposed § 405.1052(a)(1) the current
standard that in determining whether
good cause exists, the ALJ considers any
physical, mental, educational, or
linguistic limitations that the party may
have identified. We believe proposed
§ 405.1052(a)(1) would help ensure that
appellants have consistent notice of a
possible dismissal for failure to appear
and an opportunity to provide a
statement explaining why they did not
appear before a dismissal is issued. We
are proposing to revise § 423.2052(a)(1)
to adopt corresponding revisions for
dismissing a request for hearing under
part 423, subpart U.
Current OMHA policy provides that a
request for hearing that does not meet
the requirements of current § 405.1014
may be dismissed by an ALJ after an
opportunity is provided to the appellant
to cure an identified defect (OMHA Case
Processing Manual, division 2, chapter
3, section II–3–6 D and E). A dismissal
is appropriate because as an
administrative matter, the proceedings
on the request do not begin until the
information necessary to adjudicate the
request is provided and the appellant
sends a copy of the request to the other
parties. Additionally, a request cannot
remain pending indefinitely once an
appellant has demonstrated that he or
she is unwilling to provide the
necessary information or to send a copy
of the request to the other parties.
Therefore, we are proposing at
§ 405.1052(a)(7) to explain that a request
for hearing may be dismissed if the
request is not complete in accordance
with proposed § 405.1014(a)(1) or the
appellant did not send copies of its
request to the other parties in
accordance with proposed
§ 405.1014(d), after the appellant is
provided with an opportunity to
complete the request and/or send copies
of the request to the other parties. We
believe adding this provision would
emphasize the importance of following
the requirements for filing a request for
hearing, and clarify the outcome if the
requirements are not met and the
appellant does not cure identified
defects after being provided with an
opportunity to do so. We are proposing
at § 423.2052(a)(7) to adopt a
corresponding provision for dismissing
a request for hearing under part 423,
subpart U.
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As discussed above, we are proposing
to add § 405.1052(b) to explain when a
request for review of a QIC dismissal
would be dismissed. Under proposed
§ 405.1052(b), a request for review could
be dismissed in the following
circumstances: (1) the person or entity
requesting the review has no right to the
review of the QIC dismissal under
proposed § 405.1004; (2) the party did
not request a review within the stated
time period and the ALJ or attorney
adjudicator has not found good cause
for extending the deadline; (3) a
beneficiary or beneficiary’s
representative filed the request for
review and the beneficiary passed away
while the request for review is pending
and all of the following criteria apply:
(i) a surviving spouse or estate has no
remaining financial interest in the case,
(ii) no other individuals or entities have
a financial interests in the case and wish
to pursue an appeal, and (iii) no other
individual or entity filed a valid and
timely request for a review of the QIC
dismissal; and (4) the appellant’s
request for review is not complete in
accordance with proposed
§ 405.1014(a)(1) or the appellant does
not send a copy of the request to the
other parties in accordance with
proposed § 405.1014(d), after being
provided with an opportunity to
complete the request and/or send a copy
of the request to the other parties. We
believe these provisions would
encompass the reasons for dismissing a
request for a review of a QIC dismissal,
and are necessarily differentiated from
dismissing a request for hearing
because, as explained in section III.A.3.c
above, we do not believe there is a right
to a hearing for requests for a review of
a QIC dismissal. We are proposing at
§ 423.2052(b) to adopt corresponding
provisions for dismissing requests for a
review of an IRE dismissal under part
423, subpart U proceedings.
As discussed above, current
§ 405.1052(b) describes the
requirements for providing notice of the
dismissal and we are proposing to redesignate the paragraph as proposed
§ 405.1052(d). For the same reasons
discussed in section III.A.3.v above for
allowing a notice of a decision to be
provided by means other than mail, we
are proposing in § 405.1052(d) that
OMHA may mail or ‘‘otherwise
transmit’’ notice of a dismissal. We are
proposing to revise § 423.2052(d) to
adopt a corresponding revision for
notices of dismissal under part 423,
subpart U.
Current § 405.1052(b) requires notice
of the dismissal to be sent to all parties
at their last known address. However,
we believe that requirement is overly
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inclusive and causes confusion by
requiring notice of a dismissal to be sent
to parties who have not received a copy
of the request for hearing or request for
review that is being dismissed. Thus, we
are proposing to revise § 405.1052(d) to
state that the notice of dismissal is sent
to the parties who received a copy of the
request for hearing or request for review
because only those parties are on notice
that a request was pending. In addition,
we are proposing at § 405.1052(d) that if
a party’s request for hearing or request
for review is dismissed, the appeal
would proceed with respect to any other
parties who also filed a valid request for
hearing or review regarding the same
claim or disputed matter. This would
address the rare circumstance in which
more than one party submits a request,
but the request of one party is
dismissed. In that circumstance, the
appeal proceeds on the request that was
not dismissed, and the party whose
request was dismissed remains a party
to the proceedings but does not have
any rights associated with a party that
filed a request, such as the right to
escalate a request for hearing. We are
not proposing a corresponding revision
to § 423.2052(c) because only the
enrollee is a party to an appeal under
part 423, subpart U.
Current § 405.1052 does not include
authority for an ALJ to vacate his or her
own dismissal, and instead requires an
appellant to request the Council review
an ALJ’s dismissal. As explained in the
2005 Interim Final Rule (70 FR 11465),
the authority for an ALJ to vacate his or
her own dismissal was not regarded as
an effective remedy because the record
was no longer in the ALJ hearing office,
and the resolution was complicated
when appellants simultaneously asked
the ALJ to vacate the dismissal order
and asked the Council to review the
dismissal. However, in practice, the lack
of the authority for an ALJ to vacate his
or her own dismissal has constrained
ALJs’ ability to correct erroneous
dismissals that can be easily remedied
by the ALJ, and has caused unnecessary
work for the Council. We are proposing
to add § 405.1052(e) to provide the
authority for an ALJ or an attorney
adjudicator, as proposed in section II.B
above, to vacate his or her own
dismissal within 6 months of the date of
the notice of dismissal, in the same
manner as a QIC can vacate its own
dismissal. We believe that this authority
would reduce unnecessary appeals to
the Council and provide a more timely
resolution of dismissals for appellants,
whether the dismissal was issued by an
ALJ or attorney adjudicator. We also
note that the coordination for obtaining
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the administrative record and
addressing instances in which an
appellant also requests a review of the
dismissal by the Council can be
addressed through operational
coordination among CMS, OMHA, and
the DAB. We are proposing in
§ 423.2052(e) to adopt a corresponding
provision for vacating a dismissal under
part 423, subpart U.
To align the effects of a dismissal with
proposed § 405.1052(e), we are
proposing to add § 405.1054(a) to state
that the dismissal of a request for
hearing is binding unless it is vacated
by the ALJ or attorney adjudicator under
§ 405.1052(e), in addition to the current
provision that allows the dismissal to be
vacated by the Council under
§ 405.1108(b). To explain the effect of a
dismissal of a request for review of a
QIC dismissal, consistent with
§ 405.1004, we are proposing in
§ 405.1054(b) to provide that the
dismissal of a request for review of a
QIC dismissal of a request for
reconsideration is binding and not
subject to further review unless it is
vacated by the ALJ or attorney
adjudicator under § 405.1052(e). We are
proposing in § 423.2054 to adopt
corresponding revisions for the effect of
dismissals of request for hearing and
requests for review of an IRE dismissal
under part 423, subpart U.
We are inviting public comments on
these proposals. If you choose to
comment on the proposals in this
section, please include the caption
‘‘Dismissal of a request for hearing or
request for review and effect of a
dismissal of a request for hearing or
request for review’’ at the beginning of
your comment.
4. Applicability of Medicare Coverage
Policies (§§ 405.1060, 405.1062,
405.1063, 423.2062, 423.2063)
Current § 405.1060 addresses the
applicability of national coverage
determinations (NCDs) to claim appeals
brought under part 405, subpart I and
provides that an ALJ and the Council
may not disregard, set aside, or
otherwise review an NCD, but may
review the facts of a particular case to
determine whether an NCD applies to a
specific claim for benefits and, if so,
whether the NCD was applied correctly
to the claim. Current § 405.1062
addresses the applicability of local
coverage determinations (LCDs) and
other policies, and specifies that ALJs
and the Council are not bound by LCDs,
local medical review policies (LMRPs),
or CMS program guidance, such as
program memoranda and manual
instructions, but will give substantial
deference to these policies if they are
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applicable to a particular case, and if an
ALJ or the Council declines to follow a
policy in a particular case, the ALJ or
the Council must explain the reasons
why the policy was not followed.
Similarly, current § 423.2062 states that
ALJs and the Council are not bound by
CMS program guidance but will give
substantial deference to these policies if
they are applicable to a particular case,
and if an ALJ or the Council declines to
follow a policy in a particular case, the
ALJ or the Council must explain the
reasons why the policy was not
followed. Current §§ 405.1062 and
423.2062 also provide that an ALJ or
Council decision to disregard a policy
applies only to the specific claim being
considered and does not have
precedential effect. Further, § 405.1062
states that an ALJ or the Council may
not set aside or review the validity of an
LMRP or LCD for purposes of a claim
appeal. Current §§ 405.1063 and
423.2063 address the applicability of
laws, regulations, and CMS Rulings, and
provide that all laws and regulations
pertaining to the Medicare program (and
for § 405.1063 the Medicaid program as
well), including but not limited to Titles
XI, XVIII, and XIX of the Act and
applicable implementing regulations,
are binding on ALJs and the Council,
and consistent with § 401.108, CMS
Rulings are binding on all HHS
components that adjudicate matters
under the jurisdiction of CMS.
We are proposing to revise
§§ 405.1060, 405.1062, 405.1063,
423.2062, and 405.2063 to replace
‘‘ALJ’’ or ‘‘ALJs’’ with ‘‘ALJ or attorney
adjudicator’’ or ‘‘ALJs or attorney
adjudicators’’ except in the second
sentence of § 405.1062(c). As proposed
in section II.B above, an attorney
adjudicator would issue certain
decisions and dismissals and therefore
would apply the authorities addressed
by these sections. Requiring the attorney
adjudicators to apply the authorities in
the same manner as an ALJ would
provide consistency in the adjudication
process, regardless of who is assigned to
adjudicate a request for an ALJ hearing
or request for review of a QIC or IRE
dismissal. We are not proposing to
revise the second sentence in current
§ 405.1062(c) because attorney
adjudicators would not review or set
aside an LCD (or any part of an LMRP
that constitutes an LCD) in accordance
with part 426 (part 426 appeals are
currently heard by ALJs in the Civil
Remedies Division of the DAB).
We are inviting public comments on
these proposals. If you choose to
comment on the proposals in this
section, please include the caption
‘‘Applicability of Medicare Coverage
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Policies’’ at the beginning of your
comment.
5. Council Review and Judicial Review
a. Council Review: General
(§§ 405.1100, 423.1974 and 423.2100)
Current § 405.1100 discusses the
Council review process. Current
§ 405.1100(a) states that the appellant or
any other party to the hearing may
request that the Council review an ALJ’s
decision or dismissal. We are proposing
to revise § 405.1100(a) to replace ‘‘the
hearing’’ with ‘‘an ALJ’s or attorney
adjudicator’s decision or dismissal,’’
and ‘‘an ALJ’s decision or dismissal,’’
with ‘‘the ALJ’s or attorney adjudicator’s
decision or dismissal’’ because the
parties are parties to the proceedings
and the resulting decision or dismissal
regardless of whether a hearing is
conducted, and as proposed in section
II.B above, an attorney adjudicator
would be able to issue certain decisions
or dismissals for which Council review
maybe requested.
Current § 423.1974 states that an
enrollee who is dissatisfied with an ALJ
hearing decision may request that the
Council review the ALJ’s decision or
dismissal as provided in § 423.2102, and
current § 423.2100(a) states that
consistent with § 423.1974, the enrollee
may request that the Council review an
ALJ’s decision or dismissal. We are
proposing to revise § 423.1974 to
replace ‘‘ALJ hearing decision’’ with ‘‘an
ALJ’s or attorney adjudicator’s decision
or dismissal,’’ and to revise §§ 423.1974
and 423.2100(a) to replace ‘‘ALJ’s
decision or dismissal’’ with ‘‘an ALJ’s or
attorney adjudicator’s decision or
dismissal’’ because the parties are
parties to the proceedings and resulting
decision or dismissal regardless of
whether a hearing is conducted, and as
proposed in section II.B above, an
attorney adjudicator may issue a
decision or dismissal for which Council
review maybe requested.
Current § 405.1100(b) provides that
under the circumstances set forth in
§§ 405.1104 and 405.1108, an appellant
may request escalation of a case to the
Council for a decision even if the ALJ
has not issued a decision or dismissal in
his or her case. We are proposing to
revise § 405.1100(b) to provide that
under circumstances set forth in
§§ 405.1016 and 405.1108, the appellant
may request that a case be escalated to
the Council for a decision even if the
ALJ or attorney adjudicator has not
issued a decision, dismissal, or remand
in his or her case. These revisions
would reference § 405.1016, which, as
discussed in section III.A.3.h above,
would replace the current § 405.1104
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provisions for escalating a case from the
OMHA level to the Council. They would
also provide that in addition to
potentially issuing a decision or
dismissal, an ALJ or attorney
adjudicator, as proposed in section II.B
above, may issue a remand—this would
present a complete list of the actions
that an ALJ or attorney adjudicator
could take on an appeal.
Current §§ 405.1100(c) and
423.2100(b) and (c) state in part that
when the Council reviews an ALJ’s
decision, it undertakes a de novo
review, and the Council issues a final
decision or dismissal order or remands
a case to the ALJ. We are proposing to
revise §§ 405.1100(c) and 423.2100(b)
and (c) to state that when the Council
reviews an ALJ’s or attorney
adjudicator’s decision, it undertakes a
de novo review and may remand a case
to an ALJ or attorney adjudicator, so that
the same standard for review is applied
to ALJ and attorney adjudicator
decisions. We are also proposing to
revise §§ 405.1100(c) and 423.2100(c) to
state that the Council may remand an
attorney adjudicator’s decision to the
attorney adjudicator so that like an ALJ,
the attorney adjudicator can take the
appropriate action ordered by the
Council (however, if the Council were to
order that a hearing must be conducted,
the case would be transferred to an ALJ
upon remand to the attorney adjudicator
because only an ALJ may conduct a
hearing).
Current § 423.2100(c) and (d) provide
that the Council issues a final decision,
dismissal order, or remand no later than
the period of time specified in the
respective paragraph, beginning on the
date that the request for review is
received by the entity specified in the
ALJ’s written notice of decision. We are
proposing to revise § 423.2100(c) and (d)
to state that the period of time begins on
the date that the request for review is
received by the entity specified in the
ALJ’s or attorney adjudicator’s written
notice of decision because an attorney
adjudicator may also issue a decision, as
proposed in section II.B above. We are
also proposing to revise § 423.2100(c) to
correct a typographical error by
inserting ‘‘day’’ into the current ‘‘90
calendar period,’’ so it is clear to
enrollees that the period of time being
referenced is the 90 calendar day
period.
Current § 405.1100(d) states in part
that when deciding an appeal that was
escalated from the ALJ level to the
Council, the Council will issue a final
decision or dismissal order or remand
order within 180 calendar days of
receipt of the appellant’s request for
escalation. A remand from the Council
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after an appeal is escalated to it is
exceedingly rare and done in
circumstances in which the Council
must remand to an ALJ so that the ALJ
may obtain information under current
§ 405.1034 that is missing from the
written record and essential to resolving
the issues on appeal, and that
information can only be provided by
CMS or its contractors, because the
Council does not have independent
authority to obtain the information from
CMS or its contractors. In addition, an
appeal may have not yet have been
assigned to an ALJ, or could be assigned
to an attorney adjudicator as proposed
in section II.B above, when the appeal
was escalated by the appellant. We are
proposing to revise § 405.1100(d) to
state that if the Council remands an
escalated appeal, the remand is to the
OMHA Chief ALJ because the rare and
unique circumstances in which an
escalated appeal is remanded by the
Council require immediate attention
that the OMHA Chief ALJ is positioned
to provide to minimize delay for the
appellant, and to minimize confusion if
the case was not assigned to an ALJ or
attorney adjudicator when it was
escalated.
We are inviting public comments on
these proposals. If you choose to
comment on the proposals in this
section, please include the caption
‘‘Medicare Appeals Council review:
general’’ at the beginning of your
comment.
b. Request for Council Review When
the ALJ Issues Decision or Dismissal
(§§ 405.1102 and 423.2102)
Current §§ 405.1102 and 423.2102
discuss requests for Council review
when an ALJ issues a decision or
dismissal. Current §§ 405.1102(a)(1) and
423.2102(a)(1) provide that a party or
enrollee, respectively, to ‘‘the ALJ
hearing’’ may request a Council review
if the party or enrollee files a written
request for a Council review within 60
calendar days after receipt of the ALJ’s
decision or dismissal, which is in
accordance with the criteria specified in
current §§ 405.1102 and 423.2102.
However, a party or enrollee is a party
to the proceedings and resulting
decision or dismissal, and may appeal
the decision or dismissal regardless of
whether a hearing was conducted in the
appeal, and as proposed in section II.B
above, an attorney adjudicator may
issue a decision or dismissal for which
Council review may be requested. To
help ensure there is no confusion that
a party or enrollee may seek Council
review even if a hearing before an ALJ
is not conducted or if an attorney
adjudicator issues the decision or
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dismissal, we are proposing to revise
§§ 405.1102(a)(1) and 423.2102(a)(1) to
state a party or enrollee to a decision or
dismissal issued by an ALJ or attorney
adjudicator may request Council review
if the party or enrollee files a written
request for a Council review within 60
calendar days after receipt of the ALJ’s
or attorney adjudicator’s decision or
dismissal.
Current §§ 405.1102(c) and
423.2102(c) provide that a party or
enrollee, respectively, does not have a
right to seek Council review of an ALJ’s
remand to a QIC or IRE, or an ALJ’s
affirmation of a QIC’s or IRE’s dismissal
of a request for reconsideration.
However, under current §§ 405.1004(c)
and 423.2004(c), a party or enrollee,
respectively, may currently seek
Council review of a dismissal of a
request for review of a QIC or IRE
dismissal because, as discussed in
section III.A.3.x above, an ALJ does not
currently have the authority to vacate
his or her own dismissal. As proposed
in section II.B above, an attorney
adjudicator could adjudicate requests
for a review of a QIC or IRE dismissal.
In addition, proposed §§ 405.1052(e)
and 423.2052(e) would establish the
authority for an ALJ or attorney
adjudicator to vacate his or her own
dismissal, and in accordance with the
policy that a review of a dismissal is
only reviewable at the next level of
appeal, as discussed in section III.A.3.c
above, proposed §§ 405.1102(c) and
423.2102(c) would be revised to indicate
that a party does not have the right to
seek Council review of an ALJ’s or
attorney adjudicator’s dismissal of a
request for review of a QIC dismissal.
Therefore, we are proposing at
§§ 405.1102(c) and 423.2102(c) to add
that a party does not have the right to
seek Council review of an ALJ’s or
attorney adjudicator’s remand to a QIC
or IRE, affirmation of a QIC’s or IRE’s
dismissal of a request for
reconsideration, or dismissal of a
request for review of a QIC or IRE
dismissal.
We are inviting public comments on
these proposals. If you choose to
comment on the proposals in this
section, please include the caption
‘‘Request for Council review when ALJ
issues decision or dismissal’’ at the
beginning of your comment.
c. Where a Request for Review or
Escalation May Be Filed (§§ 405.1106
and 423.2106)
Current §§ 405.1106(a) and 423.2106
provide that when a request for a
Council review is filed after an ALJ has
issued a decision or dismissal, the
request for review must be filed with the
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entity specified in the notice of the
ALJ’s action, and under § 405.1106, the
appellant must also send a copy of the
request for review to the other parties to
the ALJ decision or dismissal who
received a copy of the hearing decision
or notice of dismissal. The sections also
explain that if the request for review is
timely filed with an entity other than
the entity specified in the notice of the
ALJ’s action, the Council’s adjudication
period to conduct a review begins on
the date the request for review is
received by the entity specified in the
notice of the ALJ’s action, and upon
receipt of a request for review from an
entity other than the entity specified in
the notice of the ALJ’s action, the
Council sends written notice to the
appellant of the date of receipt of the
request and commencement of the
adjudication time frame. In addition,
current § 405.1106(b) discusses that if
an appellant files a request to escalate
an appeal to the Council because the
ALJ has not completed his or her action
on the request for hearing within the
adjudication deadline under § 405.1016,
the request for escalation must be filed
with both the ALJ and the Council, and
the appellant must also send a copy of
the request for escalation to the other
parties and failure to copy the other
parties tolls the Council’s adjudication
deadline set forth in § 405.1100 until all
parties to the hearing receive notice of
the request for Council review.
We are proposing in §§ 405.1106 and
423.2106 to replace all instances of
‘‘ALJ’’ with ‘‘ALJ or attorney
adjudicator,’’ ‘‘ALJ’s action’’ with ‘‘ALJ’s
or attorney adjudicator’s action,’’ to
provide that the sections apply to
decisions and dismissals issued by an
attorney adjudicator as well, as
proposed in section II.B, and therefore
appellants would have the same right to
seek Council review of the attorney
adjudicator’s decision or dismissal, and
the Council would have the authority to
take the same actions in reviewing an
attorney adjudicator’s decision or
dismissal. We are also proposing to
replace ‘‘a copy of the hearing decision
under § 405.1046(a) or a copy of the
notice of dismissal under § 405.1052(b)’’
in § 405.1106(a) with ‘‘notice of the
decision or dismissal,’’ because
§§ 405.1046 and 405.1052 provide for
notice of a decision or dismissal,
respectively, to be sent, and a decision
or dismissal may be issued by an ALJ or
attorney adjudicator without conducting
a hearing. In addition, in describing the
consequences of failing to send a copy
of the request for review to the other
parties, we are proposing to replace
‘‘until all parties to the hearing’’ in
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§ 405.1106(a) to ‘‘until all parties to the
ALJ or attorney adjudicator decision or
dismissal,’’ to align the language with
the preceding sentences.
We are proposing to revise
§ 405.1106(b) to align the paragraph
with the revised escalation process
proposed at § 405.1016 (see section
III.A.3.h.i above). Specifically, we are
proposing to revise § 405.1106(b) to
state that if an appellant files a request
to escalate an appeal to the Council
level because the ALJ or attorney
adjudicator has not completed his or her
action on the request for hearing within
an applicable adjudication period under
§ 405.1016, the request for escalation
must be filed with OMHA and the
appellant must also send a copy of the
request for escalation to the other
parties who were sent a copy of the QIC
reconsideration. This proposed revision
would align this section with the
revised process in proposed § 405.1016
by specifying that the request for
escalation is filed with OMHA and
removing the requirement for an
appellant to also file the request with
the Council. In addition, proposed
§ 405.1106(b) would specify that the
request for escalation must be sent to
the other parties who were sent a copy
of the QIC reconsideration, which
would align with the parties to whom
the appellant is required to send a copy
of its request for hearing. Proposed
§ 405.1106(b) would also refer to ‘‘an
applicable adjudication period’’ under
§ 405.1016, to align the terminology and
because an adjudication period may not
apply to a specific case (for example, if
the appellant waived an applicable
adjudication time frame). Finally,
proposed § 405.1106(b) would provide
that failing to copy the other parties
would toll the Council’s adjudication
deadline until all parties who were sent
a copy of the QIC reconsideration
receive notice of the request for
escalation, rather than notice of the
request for Council review as is
currently required, because the revised
escalation process proposed at
§ 405.1016 would remove the
requirement to file a request for Council
review when escalation is requested
from the OMHA to the Council level.
We are inviting public comments on
these proposals. If you choose to
comment on the proposals in this
section, please include the caption
‘‘Where a request for review or
escalation may be filed’’ at the
beginning of your comment.
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d. Council Actions When Request for
Review or Escalation Is Filed
(§§ 405.1108 and 423.2108)
Current §§ 405.1108 and 423.2108
describe the actions the Council may
take upon receipt of a request for review
or, for § 405.1108, a request for
escalation. We are proposing at
§ 405.1108(d) introductory text to
replace ‘‘ALJ level’’ with ‘‘OMHA level’’
to provide that the Council’s actions
with respect to a request for escalation
are the same regardless of whether the
case was pending before an ALJ or
attorney adjudicator, or unassigned at
the time of escalation. We are also
proposing at § 405.1108(d)(3) to replace
‘‘remand to an ALJ for further
proceedings, including a hearing’’ with
‘‘remand to OMHA for further
proceedings, including a hearing’’
because we believe the Council could
remand an escalated case to an ALJ or
attorney adjudicator for further
proceedings, but if the Council ordered
that a hearing be conducted, the case
would need to be remanded to an ALJ.
We are not proposing any corresponding
changes to § 423.2108 because
escalation is not available for Part D
coverage appeals.
We are also proposing in
§§ 405.1108(b) and 423.2108(b), to
provide that the dismissal for which
Council review may be requested is a
dismissal of a request for a hearing,
because as discussed in section III.A.3.x
above, proposed §§ 405.1054(b) and
423.2054(b) would provide that a
dismissal of a request for a review of a
QIC or IRE dismissal of a request for
reconsideration is binding and not
subject to further review. Finally, we are
proposing to replace all remaining
references in §§ 405.1108 and 423.2108
to ‘‘ALJ’’ with ‘‘ALJ or attorney
adjudicator’’ and ‘‘ALJ’s’’ with ‘‘ALJ’s or
attorney adjudicator’s’’ to further
provide that the Council’s actions with
respect to a request for review or
escalation are the same for cases that
were decided by or pending before an
ALJ or an attorney adjudicator.
We are inviting public comments on
these proposals. If you choose to
comment on the proposals in this
section, please include the caption
‘‘Council actions when request for
review or escalation is filed’’ at the
beginning of your comment.
e. Council Reviews on Its Own Motion
(§§ 405.1110 and 423.2110)
Current §§ 405.1110 and 423.2110
discuss Council reviews on its own
motion. Current §§ 405.1110(a) and
423.2110(a) state the general rule that
the Council may decide on its own
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motion to review a decision or dismissal
issued by an ALJ, and CMS or its
contractor, including the IRE, may refer
a case to the Council within 60 calendar
days after the date of the ALJ’s decision
or dismissal (for § 405.1110(a)) or after
the ALJ’s written decision or dismissal
is issued (for § 423.2110(a)). Current
§§ 405.1110(b) and 423.2110(b) provide
the standards for CMS or its contractors
to refer ALJ decisions and dismissals to
the Council for potential review under
the Council’s authority to review ALJ
decisions and dismissals on the
Council’s own motion, and require that
a copy of a referral to the Council be
sent to the ALJ whose decision or
dismissal was referred, among others.
Current §§ 405.1110(c) and 423.2110(c)
explain the standards of review used by
the Council in reviewing the ALJ’s
action. Current §§ 405.1110(d) and
423.2110(d) explain the actions the
Council may take, including remanding
the case to the ALJ for further
proceedings, and state that if the
Council does not act on a referral within
90 calendar days after receipt of the
referral (unless the 90 calendar day
period has been extended as provided in
the respective subpart), the ALJ’s
decision or dismissal is binding
(§ 405.1110(d) further specifies that the
decision or dismissal is binding on the
parties to the decision).
We are proposing at §§ 405.1110 and
423.2110 to replace each instance of ‘‘at
the ALJ level’’ with ‘‘at the OMHA
level’’ and ‘‘ALJ proceedings’’ with
‘‘OMHA proceedings’’. We believe the
standards for referral to the Council by
CMS or its contractor would be the same
regardless of whether the case was
decided by an ALJ or an attorney
adjudicator, and that ‘‘at the OMHA
level’’ and ‘‘OMHA proceedings’’ would
reduce confusion in situations where
the case was decided by an attorney
adjudicator. We are proposing at
§ 405.1110(b)(2) to replace the
references to current § 405.1052(b) with
references to § 405.1052(d) to reflect the
structure of proposed § 405.1052, and
are also proposing to revise
§§ 405.1110(b)(2) and 423.2110(b)(2)(ii)
to state that CMS (in § 405.1110(b)(2)) or
CMS or the IRE (in § 423.2110(b)(2)(ii))
sends a copy of its referral to the OMHA
Chief ALJ. The current requirement to
send a copy of the referral to the ALJ is
helpful in allowing OMHA ALJs to
review the positions that CMS is
advocating before the Council, but at
times has caused confusion as to
whether the ALJ should respond to the
referral (there is no current provision
that allows the Council to consider a
statement in response to the referral). In
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addition, the proposed revision would
allow OMHA to collect information on
referrals, assess whether training or
policy clarifications for OMHA
adjudicators are necessary, and
disseminate the referral to the
appropriate ALJ or attorney adjudicator
for his or her information. We are also
proposing at § 405.1110(b)(2) to replace
‘‘all other parties to the ALJ’s decision’’
with ‘‘all other parties to the ALJ’s or
attorney adjudicator’s action’’ and at
§ 405.1110(d) to replace ‘‘ALJ decision’’
with ‘‘ALJ or attorney adjudicator
action’’ to encompass both decisions
and dismissals issued by an ALJ or an
attorney adjudicator, as proposed in
section II.B above. We believe that
parties to an ALJ’s dismissal or an
attorney adjudicator’s decision or
dismissal have the same right to receive
a copy of another party’s written
exceptions to an agency referral as the
parties to an ALJ’s decision, and that an
ALJ’s or attorney adjudicator’s decision
or dismissal is binding on the parties to
the action. We are proposing to replace
each remaining instance in §§ 405.1110
and 423.2110 of ‘‘ALJ’’ with ‘‘ALJ or
attorney adjudicator,’’ ‘‘ALJ’s decision
or dismissal’’ with ‘‘ALJ’s or attorney
adjudicator’s decision or dismissal,’’
‘‘ALJ’s decision’’ with ‘‘ALJ’s or attorney
adjudicator’s decision or dismissal,’’
and ‘‘ALJ’s action’’ with ‘‘ALJ’s or
attorney adjudicator’s action.’’ These
proposed revisions would provide that
the sections apply to decisions and
dismissals issued by an attorney
adjudicator, as proposed in section II.B,
and therefore CMS and its contractors
would have the same right to refer
attorney adjudicator decisions and
dismissals to the Council, and the
Council would have the authority to
take the same actions and have the same
obligations in deciding whether to
review an attorney adjudicator’s
decision or dismissal on its own motion.
Finally, we are proposing at
§ 423.2110(b)(1) to replace ‘‘material to
the outcome of the claim’’ with
‘‘material to the outcome of the appeal’’
because unlike Part A and Part B, no
‘‘claim’’ is submitted for drug coverage
under Part D.
We are inviting public comments on
these proposals. If you choose to
comment on the proposals in this
section, please include the caption
‘‘Council reviews on its own motion’’ at
the beginning of your comment.
f. Content of Request for Review
(§§ 405.1112 and 423.2112)
Current §§ 405.1112 and 423.2112
discuss the content of a request for
Council review. Current § 405.1112(a)
requires a request for Council review to
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contain the date of the ALJ’s decision or
dismissal order, if any, among other
information. Current § 423.2112(a)(1)
states that the request for Council
review must be filed with the entity
specified in the notice of the ALJ’s
action. Current §§ 405.1112(b) and
423.2112(b) state that the request for
review must identify the parts of the
ALJ action with which the party or
enrollee, respectively, requesting review
disagrees and explain why he or she
disagrees with the ALJ’s decision,
dismissal, or other determination being
appealed. Current § 405.1112(b)
provides an example that if the party
requesting review believes that the ALJ’s
action is inconsistent with a statute,
regulation, CMS Ruling, or other
authority, the request for review should
explain why the appellant believes the
action is inconsistent with that
authority. Current §§ 405.1112(c) and
423.2112(c) state that the Council will
limit its review of an ALJ’s action to
those exceptions raised by the party or
enrollee, respectively, in the request for
review, unless the appellant is an
unrepresented beneficiary or the
enrollee is unrepresented. We are
proposing at §§ 405.1112 and 423.2112
to replace ‘‘ALJ’s decision or dismissal’’
with ‘‘ALJ’s or attorney adjudicator’s
decision or dismissal,’’ ‘‘ALJ action’’
with ‘‘ALJ or attorney adjudicator’s
action,’’ ‘‘ALJ’s action’’ with ‘‘ALJ’s or
attorney adjudicator’s action.’’ These
proposed revisions would provide that
the sections apply to decisions and
dismissals issued by an attorney
adjudicator, as proposed in section II.B,
and therefore information on the
attorney adjudicator’s decision and
dismissal must be included in the
request for Council review, and the
scope of the Council’s review would be
the same as for an ALJ’s decision or
dismissal.
Current § 405.1112(a) states that a
request for Council review must be filed
with the Council or appropriate ALJ
hearing office. However, this provision
may cause confusion when read with
current § 405.1106(a), which states that
a request for review must be filed with
the entity specified in the notice of the
ALJ’s action. In practice, OMHA notices
of decision and dismissal provide
comprehensive appeal instructions
directing requests for Council review to
be filed directly with the Council, and
provide address and other contact
information for the Council. Therefore,
we are proposing to revise § 405.1112(a)
to state that the request for Council
review must be filed with the entity
specified in the notice of the ALJ’s or
attorney adjudicator’s action, which
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would to align § 405.1112(a) with
current § 405.1106(a), and reaffirm that
a request for Council review must be
filed with the entity specified in the
notice of the ALJ’s or attorney
adjudicator’s action.
Current § 405.1112(a) also states that
the written request for review must
include the hearing office in which the
appellant’s request for hearing is
pending if a party is requesting
escalation from an ALJ to the Council.
In light of the proposed revisions to the
escalation process discussed in section
III.A.3.h.i above, we are proposing to
remove this requirement from
§ 405.1112(a) because proposed
§ 405.1016 would provide that a request
for escalation is filed with OMHA. In
accordance with proposed § 405.1016, if
the request for escalation meets the
requirements of § 405.1016(f)(1) and a
decision, dismissal, or remand cannot
be issued within 5 calendar days after
OMHA receives the request, the appeal
would be forwarded to the Council.
We are inviting public comments on
these proposals. If you choose to
comment on the proposals in this
section, please include the caption
‘‘Content of request for review’’ at the
beginning of your comment.
g. Dismissal of Request for Review
(§§ 405.1114 and 423.2114)
We are proposing at § 405.1114(c)(3)
to replace ‘‘ALJ hearing’’ with ‘‘ALJ’s or
attorney adjudicator’s action.’’ This
proposed revision would provide that
the paragraph applies to decisions and
dismissals issued by an attorney
adjudicator, as proposed in section II.B,
and therefore a valid and timely request
for Council review filed by another
party to an attorney adjudicator’s
decision or dismissal would preclude
dismissal of a request for Council
review under § 405.1114(c). We are not
proposing any corresponding changes to
§ 423.1114 because there is no provision
equivalent to current § 405.1114(c)(3).
We are inviting public comments on
these proposals. If you choose to
comment on the proposals in this
section, please include the caption
‘‘Dismissal of request for review’’ at the
beginning of your comment.
h. Effect of Dismissal of Request for
Council Review or Request for Hearing
(§§ 405.1116 and 423.2116)
Current §§ 405.1116 and 423.2116
describe the effect of a dismissal by the
Council of a request for Council review
or a request for hearing. We are
proposing to replace ‘‘ALJ’’ with ‘‘ALJ or
attorney adjudicator’’ to provide that the
denial of a request for Council review of
a dismissal issued by an attorney
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adjudicator is binding and not subject to
judicial review in the same manner as
the denial of a request for Council
review of a dismissal issued by an ALJ.
We believe the Council’s denial of a
request to review an attorney
adjudicator’s dismissal would be subject
to the same general rules described in
sections III.A.3.c and III.A.3.x above
pertaining to reviews of dismissals at
the next adjudicative level, and that
further review of the attorney
adjudicator’s dismissal in Federal
district court would be unavailable.
We are inviting public comments on
these proposals. If you choose to
comment on the proposals in this
section, please include the caption
‘‘Effect of dismissal of request for
Council review or request for hearing’’
at the beginning of your comment.
i. Obtaining Evidence From the Council
(§§ 405.1118 and 423.2118)
Current §§ 405.1118 and 423.2118
provide that a party or an enrollee,
respectively, may request and receive a
copy of all or part of the record of the
ALJ hearing. We are proposing to
replace ‘‘ALJ hearing’’ with ‘‘ALJ’s or
attorney adjudicator’s action.’’ This
proposed revision would provide that a
party to an attorney adjudicator action,
or to an ALJ decision that was issued
without a hearing, may request and
receive a copy of all or part of the record
to the same extent as a party to an ALJ
hearing. We are also proposing to
replace the reference to an ‘‘exhibits
list’’ with a reference to ‘‘any index of
the administrative record’’ to provide
greater flexibility in developing a
consistent structure for the
administrative record. In addition, we
are proposing at § 405.1118 to replace
the reference to a ‘‘tape’’ of the oral
proceeding with an ‘‘audio recording’’
of the oral proceeding because tapes are
no longer used and a more general
reference would accommodate future
changes in recording formats. We are
proposing a parallel revision to
§ 423.2118 to replace the reference to a
‘‘CD’’ of the oral proceeding with an
‘‘audio recording’’ of the oral
proceeding.
We are inviting public comments on
these proposals. If you choose to
comment on the proposals in this
section, please include the caption
‘‘Obtaining evidence from the Council’’
at the beginning of your comment.
j. What Evidence May Be Submitted to
the Council (§§ 405.1122 and 423.2122)
Current §§ 405.1122 and 423.2122
describe the evidence that may be
submitted to and considered by the
Council, the process the Council follows
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in issuing subpoenas, the reviewability
of Council subpoena rulings, and the
process for seeking enforcement of
subpoenas. Current § 405.1122(a)(1)
provides that the Council will limit its
review of the evidence to the evidence
contained in the record of the
proceedings before the ALJ, unless the
hearing decision decides a new issue
that the parties were not afforded an
opportunity to address at the ALJ level.
We are proposing at § 405.1122(a)
introductory text and (a)(1) to replace
each instance of ‘‘ALJ’s decision’’ with
‘‘ALJ’s or attorney adjudicator’s
decision,’’ ‘‘before the ALJ’’ with
‘‘before the ALJ or attorney
adjudicator,’’ and ‘‘the ALJ level’’ with
‘‘the OMHA level.’’ We believe the
standard for review of evidence at the
Council level would be the same
regardless of whether the case was
decided by an ALJ or attorney
adjudicator, as proposed in section II.B
above, at the OMHA level. We are also
proposing corresponding revisions to
§ 423.2122(a) introductory text and
(a)(1). Also, to help ensure it is clear
that the exception for evidence related
to new issues raised at the OMHA level
is not limited to proceedings in which
a hearing before an ALJ was conducted,
we are proposing at §§ 405.1122(a)(1)
and § 423.2122(a)(1) to replace ‘‘hearing
decision’’ with ‘‘ALJ’s or attorney
adjudicator’s decision.’’ Current
§ 405.1122(a)(2) provides that if the
Council determines that additional
evidence is needed to resolve the issues
in the case, and the hearing record
indicates that the previous decisionmakers have not attempted to obtain the
evidence, the Council may remand the
case to an ALJ to obtain the evidence
and issue a new decision. For the
reasons described above, we are
proposing at § 405.1122(a)(2) to replace
‘‘ALJ’’ with ‘‘ALJ or attorney
adjudicator’’ and ‘‘hearing record’’ with
‘‘administrative record,’’ along with
corresponding revisions to
§ 423.2122(a)(2). Current
§ 405.1122(b)(1) describes the evidence
that may be considered by the Council
when a case is escalated from the ALJ
level. For the reasons described above,
we are proposing to replace ‘‘ALJ level’’
with ‘‘OMHA level.’’ We are not
proposing any corresponding changes to
§ 423.2122 because escalation is not
available for Part D coverage appeals.
Finally, we are proposing to replace all
remaining instances of ‘‘ALJ’’ in
§ 405.1122(b)(1), (b)(2), (c)(2), (c)(3)
introductory text, (c)(3)(i), and (c)(3)(ii)
with ‘‘ALJ or attorney adjudicator,’’ as
we believe the Council’s authority to
consider evidence entered in the record
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by an attorney adjudicator and to
remand a case to an attorney adjudicator
for consideration of new evidence
would be the same as the Council’s
current authority to consider evidence
entered in the record by an ALJ and
remand a case to an ALJ. We are not
proposing any corresponding changes to
§ 423.2122 because there are no
remaining references to ‘‘ALJ.’’
We are inviting public comments on
these proposals. If you choose to
comment on the proposals in this
section, please include the caption
‘‘What evidence may be submitted to
the Council’’ at the beginning of your
comment.
k. Case Remanded by the Council
(§§ 405.1126 and 423.2126)
Current §§ 405.1126(a) and (b) explain
the Council’s remand authority. We are
proposing to replace each instance of
‘‘ALJ’’ with ‘‘ALJ or attorney
adjudicator’’ to provide that the Council
may remand a case in which additional
evidence is needed or additional action
is required by the ALJ or attorney
adjudicator, as proposed in section II.B
above. Proposed § 405.1126(b) would
also provide that an ALJ or attorney
adjudicator would take any action that
is ordered by the Council, and may take
any additional action that is not
inconsistent with the Council’s remand
order. We believe it is necessary for the
Council to have the same authority to
remand an attorney adjudicator’s
decision to the attorney adjudicator as
the Council currently has to remand an
ALJ’s decision to the ALJ, and that the
attorney adjudicator’s actions with
respect to the remanded case should be
subject to the same requirements as an
ALJ’s actions under the current
provisions. We are also proposing
corresponding revisions to
§ 423.2126(a)(1) and (a)(2). Current
§§ 405.1126(c) and (d) describe the
procedures that apply when the Council
receives a recommended decision from
the ALJ, including the right of the
parties to file briefs or other written
statements with the Council. Because
we are proposing in § 405.1126(a) for
the Council to have the same authority
to order an attorney adjudicator to issue
a recommended decision on remand as
the Council currently has to order an
ALJ to issue a recommended decision,
we are also proposing at § 405.1126(c)
and (d) to replace ‘‘ALJ’’ with ‘‘ALJ or
attorney adjudicator’’ to provide that the
provisions apply to attorney
adjudicators to the same extent as the
provisions apply to ALJs, along with
corresponding revisions to
§ 423.2126(a)(3) and (a)(4). Finally,
current § 405.1126(e)(2) provides that if
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the Council determines more evidence
is required after receiving a
recommended decision, the Council
may again remand the case to an ALJ for
further development and another
decision or recommended decision.
Because we believe the Council should
have the same authority to remand a
case to an attorney adjudicator
following receipt of a recommended
decision, we are proposing at
§ 405.1126(e)(2) to replace ‘‘ALJ’’ with
‘‘ALJ or attorney adjudicator,’’ along
with a corresponding revision to
§ 423.2126(a)(5)(ii), and to insert ‘‘if
applicable’’ after rehearing because a
rehearing may not be applicable in
every circumstance (for example, where
an attorney adjudicator issued a
recommended decision and the Council
does not remand with instructions to
transfer the appeal to an ALJ for a
hearing).
We are inviting public comments on
these proposals. If you choose to
comment on the proposals in this
section, please include the caption
‘‘Case remanded by the Council’’ at the
beginning of your comment.
l. Action of the Council (§§ 405.1128
and 423.2128)
Current §§ 405.1128 and 423.2128
explain the actions the Council may
take after reviewing the administrative
record and any additional evidence
(subject to the limitations on Council
consideration of additional evidence).
We are proposing at §§ 405.1128(a) and
423.2128(a) to replace ‘‘ALJ’’ with ‘‘ALJ
or attorney adjudicator,’’ which would
provide that the Council may make a
decision or remand a case to an ALJ or
to an attorney adjudicator (as proposed
in section II.B above). We believe the
Council should have the same authority
to remand a case to an attorney
adjudicator as the Council currently has
to remand a case to an ALJ. Also, to help
ensure there is no confusion that
Council actions are not limited to
proceedings in which a hearing before
an ALJ was conducted, we are
proposing at §§ 405.1128(b) and
423.2128(b) to replace ‘‘the ALJ hearing
decision’’ with ‘‘the ALJ’s or attorney
adjudicator’s decision.’’
We are inviting public comments on
these proposals. If you choose to
comment on the proposals in this
section, please include the caption
‘‘Action of the Council’’ at the beginning
of your comment.
m. Request for Escalation to Federal
Court (§ 405.1132)
Current § 405.1132 explains the
process for an appellant to seek
escalation of an appeal (other than an
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appeal of an ALJ dismissal) from the
Council to Federal district court if the
Council does not issue a decision or
dismissal or remand the case to an ALJ
within the adjudication time frame
specified in § 405.1100, or as extended
as provided in subpart I. We are
proposing at § 405.1132 to replace each
instance of ‘‘ALJ’’ with ‘‘ALJ or attorney
adjudicator.’’ These revisions would
provide that the appellant may request
that escalation of a case, other than a
dismissal issued by an ALJ or attorney
adjudicator, as proposed in section II.B
above to Federal district court if the
Council is unable to issue a decision or
dismissal or remand the case to an ALJ
or attorney adjudicator within an
applicable adjudication time frame, and
that appellants may file an action in
Federal district court if the Council is
not able to issue a decision, dismissal,
or remand to the ALJ or attorney
adjudicator within 5 calendar days of
receipt of the request for escalation or 5
calendar days from the end of the
applicable adjudication time period. We
are not proposing any corresponding
changes to part 423, subpart U, as there
is no equivalent provision because there
are no escalation rights for Part D
coverage appeals.
We are inviting public comments on
these proposals. If you choose to
comment on the proposals in this
section, please include the caption
‘‘Request for escalation to Federal
court’’ at the beginning of your
comment.
n. Judicial Review (§§ 405.1136,
423.1976, and 423.2136)
Current §§ 405.1136, 423.1976, and
423.2136 set forth the right to file a
request for judicial review in Federal
district court of a Council decision (or
of an ALJ’s decision if the Council
declines review as provided in
§ 423.1976(a)(1)). Current § 405.1136
also provides that judicial review in
Federal district court may be requested
if the Council is unable to issue a
decision, dismissal, or remand within
the applicable time frame following an
appellant’s request for escalation. In
addition, current §§ 405.1136 and
423.2136 specify the requirements and
procedures for filing a request for
judicial review, the Federal district
court in which such actions must be
filed, and describe the standard of
review. We are proposing at
§§ 405.1136, 423.1976, and 423.2136 to
replace each instance of ‘‘ALJ’’ with
‘‘ALJ or attorney adjudicator,’’ and
‘‘ALJ’s’’ with ‘‘ALJ’s or attorney
adjudicator’s’’ to help ensure that there
is no confusion that appellants may file
a request for judicial review in Federal
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district court of actions made by an
attorney adjudicator, as proposed in
section II.B above (or by the Council
following an action by an attorney
adjudicator), to the same extent that
judicial review is available for ALJ
actions (or Council actions following an
action by an ALJ).
We are inviting public comments on
these proposals. If you choose to
comment on the proposals in this
section, please include the caption
‘‘Judicial review’’ at the beginning of
your comment.
o. Case Remanded by a Federal Court
(§§ 405.1138 and 423.2138)
Current §§ 405.1138 and 423.2138 set
forth the actions the Council may take
when a Federal district court remands a
case to the Secretary for further
consideration. We are proposing at
§§ 405.1138 and 423.2138, and 405.1140
and 423.2140 to replace ‘‘ALJ’’ with
‘‘ALJ or attorney adjudicator’’ to provide
that when a case is remanded by a
Federal district court for further
consideration by the Secretary, the
Council may remand the case to an ALJ
or attorney adjudicator (as proposed in
section II.B above), to issue a decision,
take other action, or return the case to
the Council with a recommended
decision.
We are inviting public comments on
these proposals. If you choose to
comment on the proposals in this
section, please include the caption
‘‘Case remanded by a Federal court’’ at
the beginning of your comment.
p. Council Review of ALJ Decision in a
Case Remanded by a Federal District
Court (§§ 405.1140 and 423.2140)
Current §§ 405.1140 and 423.2140 set
forth the procedures that apply when a
case is remanded to the Secretary for
further consideration, and the Council
subsequently remands the case to an
ALJ, including the procedures for the
Council to assume jurisdiction
following the decision of the ALJ on its
own initiative or upon receipt of written
exceptions from a party or the enrollee.
We are proposing to replace each
instance of ‘‘ALJ’’ throughout
§§ 405.1140 and 423.2140 with ‘‘ALJ or
attorney adjudicator’’ and to replace the
reference to ‘‘ALJ’s’’ at §§ 405.1140(d)
and 423.2140(d) with ‘‘ALJ’s or attorney
adjudicator’s.’’ These revisions would
provide that the Council may remand
these cases to the ALJ or attorney
adjudicator, as proposed in section II.B
above, following remand from a Federal
district court, and that the decision of
the ALJ or attorney adjudicator becomes
the final decision of the Secretary after
remand unless the Council assumes
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jurisdiction. These revisions would
further apply the rules set forth in this
section to cases reviewed by an attorney
adjudicator as well as an ALJ. As
described above in relation to the
Council’s general remand authority
under §§ 405.1126 and 423.2126, we
believe it is necessary for the Council to
have the same authority to remand an
attorney adjudicator’s decision to the
attorney adjudicator as the Council
currently has to remand an ALJ’s
decision to the ALJ, and that would
include cases that are remanded by a
Federal district court to the Secretary for
further consideration.
We are inviting public comments on
these proposals. If you choose to
comment on the proposals in this
section, please include the caption
‘‘Council review of ALJ decision in a
case remanded by a Federal district
court’’ at the beginning of your
comment.
B. Part 405, Subpart J Expedited
Reconsiderations (§ 405.1204)
In accordance with section
1869(b)(1)(F) of the Act, current
§ 405.1204 provides for expedited QIC
reconsiderations of certain QIO
determinations related to providerinitiated terminations of Medicarecovered services and beneficiary
discharges from a provider’s facility.
Current § 405.1204(c)(4)(iii) explains
that the QIC’s initial notification may be
done by telephone followed by a written
notice that includes information about
the beneficiary’s right to appeal the
QIC’s reconsideration decision to an
ALJ, and current § 405.1204(c)(5)
provides that if the QIC does not issue
a decision within 72 hours of receipt of
the request for a reconsideration, the
case can be escalated to the ‘‘ALJ
hearing level.’’ For consistency with
part 405, subpart I, and to explain the
rules that apply to an ALJ hearing, we
are proposing at § 405.1204(c)(4)(iii) and
(c)(5) to amend these references to
convey that a QIC reconsideration can
be appealed to, or a request for a QIC
reconsideration can be escalated to
OMHA for an ALJ hearing in accordance
with part 405, subpart I. We believe
these revisions would explain where a
request for an ALJ hearing is directed
from a subpart J proceeding, and the
rules that would be applied to the
request for an ALJ hearing following the
QIC’s reconsideration or escalation of
the request for a QIC reconsideration.
Current § 405.1204(c)(5) states that the
beneficiary has a right to escalate a
request for a QIC reconsideration if the
amount remaining in controversy after
the QIO determination is $100 or more.
However, this is inconsistent with the
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amount in controversy specified in
section 1869(b)(1)(E) of the Act. We are
proposing to revise § 405.1204(c)(5) to
provide that there is a right to escalate
a request for a QIC reconsideration if the
amount remaining in controversy after
the QIO determination meets the
requirements for an ALJ hearing under
§ 405.1006. We believe that this is more
consistent with section 1869(b)(1)(E) of
the Act, which provides that a hearing
by the Secretary shall not be available
to an individual if the amount in
controversy is less than $100, as
adjusted annually after 2004, which is
implemented in § 405.1006, and would
bring consistency to the amounts in
controversy required for an escalation
under subpart J and subpart I.
We are inviting public comments on
these proposals. If you choose to
comment on the proposals in this
section, please include the caption ‘‘Part
405, subpart J expedited
reconsiderations’’ at the beginning of
your comment.
C. Part 422, Subpart M
1. General Provisions (§ 422.562)
Current § 422.562(c)(1)(ii) states that if
an enrollee receives immediate QIO
review of a determination of noncoverage of inpatient hospital care, the
QIO review decision is subject only to
the appeal procedures set forth in parts
476 and 478 of title 42, chapter IV.
However, we believe this provision is an
outdated reference that has been
superseded by current § 422.622, which
provides for requesting immediate QIO
review of the decision to discharge an
enrollee from an inpatient hospital
setting and appeals of that review as
described under part 422, subpart M.
The regulatory provisions at § 422.622
describe the processes for QIO review of
the decision to discharge an MA
enrollee from the inpatient hospital
setting. Section 422.622 also explains
the availability of other appeals
processes if the enrollee does not meet
the deadline for an immediate QIO
review of the discharge decision. These
part 422, subpart M provisions govern
the review processes for MA enrollees
disputing discharge from an inpatient
hospital setting. As noted above, we
believe the references to the procedures
in parts 476 and 478 at
§ 422.562(c)(1)(ii) are obsolete.
Therefore, we are proposing to delete
§ 422.562(c)(1) to remove the outdated
reference in current § 422.562(c)(1)(ii)
and consolidate current (c)(1) and
(c)(1)(i) into proposed (c)(1). We also
note that changes to § 422.562(d) are
proposed and discussed in section II.C,
above.
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We are inviting public comments on
these proposals. If you choose to
comment on the proposals in this
section, please include the caption
‘‘General provisions’’ at the beginning of
your comment.
2. Notice of Reconsidered Determination
by the Independent Entity (§ 422.594)
Current § 422.594(b)(2) requires the
notice of the reconsideration
determination by an IRE to inform the
parties of their right to an ALJ hearing
if the amount in controversy is $100 or
more, if the determination is adverse
(does not completely reverse the MAO’s
adverse organization determination). We
are proposing at § 422.594(b)(2) to
amend this requirement so that the
notice informs the parties of their right
to an ALJ hearing if the amount in
controversy meets the requirements of
§ 422.600, which in turn refers to the
part 405 computation of the amount in
controversy. We believe this would
increase accuracy in conveying when a
party has a right to an ALJ hearing, and
would be more consistent with section
1852(g)(5) of the Act, which provides
that a hearing by the Secretary shall not
be available to an individual if the
amount in controversy is less than $100,
as adjusted annually in accordance with
section 1869(b)(1)(E)(iii) of the Act,
which is implemented in part 405 at
§ 405.1006. We discuss proposed
changes to § 405.1006 in section
III.A.3.d above.
We are inviting public comments on
these proposals. If you choose to
comment on the proposals in this
section, please include the caption
‘‘Notice of reconsidered determination
by the independent entity’’ at the
beginning of your comment.
3. Request for an ALJ Hearing
(§ 422.602)
Current § 422.602(b) provides that a
party must file a request for an ALJ
hearing within 60 days of the date of the
notice of the IRE’s reconsidered
determination. However, in similar
appeals brought under Medicare Part A
and Part B at § 405.1002, and Part D at
§ 423.2002, a request for an ALJ hearing
must be filed within 60 calendar days of
receipt of a notice of reconsideration.
We are proposing at § 422.602(b)(1) to
align the part 422 time frame for filing
a request for an ALJ hearing with
provisions for similar appeals under
Medicare Part A and Part B, and Part D.
As proposed, a request for an ALJ
hearing would be required to be filed
within 60 calendar days of receiving the
notice of a reconsidered determination,
except when the time frame is extended
by an ALJ or, as proposed, attorney
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adjudicator, as provided in part 405. To
provide consistency for when a notice of
a reconsidered determination is
presumed to have been received, we are
proposing at § 422.602(b)(2) that the
date of receipt of the reconsideration is
presumed to be 5 calendar days after the
date of the notice of the reconsidered
determination, unless there is evidence
to the contrary, which is the same
presumption that is applied to similar
appeals under Medicare Part A and Part
B at § 405.1002, and Part D at
§ 423.2002.
We are inviting public comments on
these proposals. If you choose to
comment on the proposals in this
section, please include the caption
‘‘Request for an ALJ hearing’’ at the
beginning of your comment.
4. Medicare Appeals Council (Council)
Review (§ 422.608)
Current § 422.608 provides that any
party to the hearing, including the
MAO, who is dissatisfied with the ALJ
hearing decision may request that the
Council review the ALJ’s decision or
dismissal. We believe that the reference
to a hearing, hearing decision, then
decision or dismissal may cause
confusion regarding a party’s right to
request Council review. We are
proposing at § 422.608 that any party to
the ALJ’s or, as proposed in section II.B
above, attorney adjudicator’s decision or
dismissal, including the MAO, who is
dissatisfied with the decision or
dismissal, may request that the Council
review the decision or dismissal. We
believe this would resolve any potential
confusion regarding a party’s right to
request Council review of a decision
when a hearing was not conducted, and
a dismissal of a request for hearing, and
provide that the section applies to
decisions and dismissals issued by an
attorney adjudicator, as proposed in
section II.B. Therefore, proposed
§ 422.608 would provide that a request
for Council review may be filed by a
party if he or she is dissatisfied with an
ALJ’s or attorney adjudicator’s decision
or dismissal.
We are inviting public comments on
these proposals. If you choose to
comment on the proposals in this
section, please include the caption
‘‘Medicare Appeals Council (Council)
review’’ at the beginning of your
comment. We discuss other proposed
changes to § 422.608 in section II.D
above.
5. Judicial Review (§ 422.612)
Current § 422.612 provides the
circumstances under which a party may
request judicial review of an ALJ or
Council decision, and directs appellants
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to the procedures in part 405 for filing
a request for judicial review. We are
proposing at § 422.612(a) to replace each
instance of ‘‘ALJ’s’’ with ‘‘ALJ’s or
attorney adjudicator’s’’. Thus, as
provided in § 422.612(a), appellants
would be able to file a request for
judicial review in Federal district court
of actions made by an attorney
adjudicator, as proposed in section II.B
above (or by the Council following an
action by an attorney adjudicator), to the
same extent that judicial review is
available under § 412.622(a) for ALJ
actions (or Council actions following an
action by an ALJ).
We are inviting public comments on
these proposals. If you choose to
comment on the proposals in this
section, please include the caption
‘‘Judicial review’’ at the beginning of
your comment.
6. Reopening and Revising
Determinations and Decisions
(§ 422.616)
Current § 422.616(a) provides that the
determination or decision of an MA
organization, independent entity, ALJ,
or the Council that is otherwise final
and binding may be reopened and
revised by the entity that made the
determination or decision, subject to the
rules in part 405. We are proposing at
§ 422.616(a) to replace ‘‘ALJ’’ with ‘‘ALJ
or attorney adjudicator.’’ As described
in section III.A.2.l above with respect to
§§ 405.980, 405.982, 405.984, 423.1980,
423.1982, and 423.1984, we believe it is
necessary for an attorney adjudicator to
have the authority to reopen the
attorney adjudicator’s decision on the
same bases as an ALJ may reopen the
ALJ’s decision under the current rules,
and the action should be subject to the
same limitations and requirements, and
have the same effects as an ALJ’s action
under these provisions.
We are inviting public comments on
these proposals. If you choose to
comment on the proposals in this
section, please include the caption
‘‘Reopening and revising determinations
and decisions’’ at the beginning of your
comment.
7. How an MA Organization Must
Effectuate Standard Reconsideration
Determinations and Decisions, and
Expedited Reconsidered Determinations
(§§ 422.618 and 422.619)
Current § 422.618(c)(1) and (c)(2)
provide instructions for effectuation of
decisions issued by an ALJ, or at a
higher level of appeal, that reverse an
IRE’s decision on a standard
reconsidered determination or decision.
We are proposing to replace ‘‘ALJ’’ with
‘‘ALJ or attorney adjudicator’’ at
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§ 422.618(c)(1) and to make
corresponding changes to
§ 422.619(c)(1) for decisions that reverse
an IRE’s decision on an expedited
reconsidered determination or decision.
We believe the process for effectuating
the decision of an attorney adjudicator,
as proposed in section II.B above,
should be the same as the process for
effectuating the decision of an ALJ.
We are inviting public comments on
these proposals. If you choose to
comment on the proposals in this
section, please include the caption
‘‘How an MA organization must
effectuate standard reconsideration
determinations and decisions, and
expedited reconsidered determinations’’
at the beginning of your comment.
8. Requesting Immediate QIO Review of
the Decision to Discharge From the
Inpatient Hospital and Fast-Track
Appeals of Service Terminations to
Independent Review Entities (IREs)
(§§ 422.622 and 422.626).
In accordance with section 1852(g)(3)
and (g)(4) of the Act, current §§ 422.622
and 422.626 provide for reviews of QIO
determinations and expedited IRE
reconsiderations of certain QIO
determinations related to terminations
of covered provider services furnished
by home health agencies (HHAs), skilled
nursing facilities (SNFs), and
comprehensive outpatient rehabilitation
facilities (CORFs) to a Medicare
Advantage enrollee, and Medicare
Advantage enrollee discharges from an
inpatient hospital. Current § 422.622(g)
provides that if an enrollee is still an
inpatient in the hospital after a QIO
determination reviewing a provider
discharge from a hospital, the enrollee
may request an IRE reconsideration of
the QIO determination in accordance
with § 422.626(g); and if an enrollee is
no longer an inpatient in the hospital,
the enrollee may appeal the QIO
determination to an ALJ. Current
§ 422.626(g)(3) provides that if the IRE
reaffirms its decision to terminate
covered provider services furnished by
a HHA, SNF, or CORF in whole or in
part, the enrollee may appeal the IRE’s
reconsidered determination to an ALJ.
We are proposing at §§ 422.622(g)(2)
and 422.626(g)(3) to amend these
references to provide that the appeal is
made to OMHA for an ALJ hearing. We
believe these revisions would clarify
where a request for an ALJ hearing is
directed.
We are inviting public comments on
these proposals. If you choose to
comment on the proposals in this
section, please include the caption
‘‘Requesting immediate QIO review of
the decision to discharge from the
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inpatient hospital and fast-track appeals
of service terminations to independent
review entities (IREs)’’ at the beginning
of your comment.
D. Part 478, Subpart B
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1. Applicability and Beneficiary’s Right
to a Hearing (§§ 478.14 and 478.40)
Current § 478.14(c)(2) explains that
for the purposes of part 478
reconsideration and appeals, limitation
of liability determinations on excluded
coverage of certain services are made
under section 1879 of the Act, and
initial determinations under section
1879 of the Act and further appeals are
governed by the reconsideration and
appeal procedures in part 405, subpart
G for determinations under Medicare
Part A, and part 405, subpart H for
determinations under Medicare Part B.
In addition, current § 478.40 states that
an ALJ hearing may be obtained from
the SSA Office of Hearings and Appeals,
and the provisions of subpart G of 42
CFR part 405 apply unless they are
inconsistent with the specific provisions
of subpart B of 42 CFR part 478. These
references are outdated. Since §§ 478.14
and 478.40 were last updated in 1999,
section 931 of the MMA transferred
responsibility for the ALJ hearing
function from SSA to HHS, and HHS
established OMHA in 2005, to
administer the ALJ hearing function,
including ALJ hearings conducted
under titles XI and XVIII of the Social
Security Act (see 70 FR 36386). In
addition, BIPA and the MMA
established new appeal procedures that
were implemented in 2005, at 42 CFR
part 405, subpart I (70 FR 11420), and
the portions of subparts G and H that
previously applied to part 478, subpart
B appeals were removed in 2012 (77 FR
29002). Proposed §§ 478.14 and 478.40
would replace the current outdated
references to part 405, subparts G and H,
with references to part 405, subpart I.
Proposed § 478.40 would also update
the reference to the entity with
responsibility for the ALJ hearing
function by replacing the SSA Office of
Hearings and Appeals with OMHA.
We are inviting public comments on
these proposals. If you choose to
comment on the proposals in this
section, please include the caption
‘‘Applicability and beneficiary’s right to
a hearing’’ at the beginning of your
comment.
2. Submitting a Request for a Hearing
(§ 478.42)
Similar to current § 478.40, as
discussed above, current § 478.42(a) has
outdated references to SSA offices that
are no longer involved in the Medicare
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claim appeals process. In addition,
current § 478.42(a) permits beneficiaries
to file requests for an ALJ hearing with
other entities, which could cause
significant delays in obtaining a hearing
before an OMHA ALJ. Proposed
§ 478.42(a) would direct beneficiaries to
file a request for an ALJ hearing with the
OMHA office identified in the QIO’s
notice of reconsidered determination.
This revision would be clearer for
beneficiaries, who are provided with
appeal instructions by the QIOs, and
reduce delays in obtaining a hearing by
an OMHA ALJ.
Current § 478.42(b) requires that a
request for hearing is filed within 60
calendar days of receipt of the notice of
the QIO reconsidered determination and
the date of receipt is assumed to be 5
days after the date on the notice unless
there is a reasonable showing to the
contrary. Current § 478.42(b) also
provides that a request is considered
filed on the date it is postmarked. To
align part 478, subpart B with
procedures for requesting an ALJ
hearing under part 405, subpart I; part
422, subpart M; and part 423, subpart U,
proposed § 478.42(b) would provide that
the request for hearing must be filed
within 60 ‘‘calendar’’ days of receiving
notice of the QIO reconsidered
determination and that the notice is
presumed to be received 5 ‘‘calendar’’
days after the date of the notice. In
addition, to further align the part 478,
subpart B procedures for requesting an
ALJ hearing with the other parts,
proposed § 478.42(c) would amend the
standard to demonstrate that notice of
QIO reconsidered determination was
not received within 5 calendar days by
requiring ‘‘evidence’’ rather than the
current ‘‘reasonable showing,’’ and
would also revise when a request is
considered filed, from the date it is
postmarked to the date it is received by
OMHA. These changes would create
parity with requests for hearing filed by
beneficiaries and enrollees for similar
services but under other parts of title 42,
chapter IV.
We are inviting public comments on
these proposals. If you choose to
comment on the proposals in this
section, please include the caption
‘‘Submitting a request for a hearing’’ at
the beginning of your comment.
3. Determining the Amount in
Controversy (§ 478.44)
Current § 478.44(a) explains how the
amount in controversy for an ALJ
hearing is determined in part 478,
subpart B hearings. Current § 478.44(a)
has outdated references to §§ 405.740
and 405.817 from part 405, subparts G
and H respectively, for calculating the
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amount in controversy for an individual
appellant or multiple appellants. In
2012, subpart G was removed and
subpart H was significantly revised and
no longer applies to Medicare claim
appeals (77 FR 29002). To update these
reference to the current part 405 rules,
proposed § 478.44(a) would replace the
outdated cross-references for calculating
the amount in controversy with
§ 405.1006(d) and (e), which describe
the calculation for determining the
amount in controversy and the
standards for aggregating claims by an
individual appellant or multiple
appellants. We discuss proposed
changes to § 405.1006 in section
III.A.3.d above.
Current § 478.44(b) and (c) explain
that if an ALJ determines the amount in
controversy is less than $200, the ALJ,
without holding a hearing, notifies the
parties to the hearing, and if a request
for hearing is dismissed because the
amount in controversy is not met, a
notice will be sent to the parties to the
hearing. However, when a request for
hearing is dismissed because the
amount in controversy is not met, no
hearing is conducted and the parties are
parties to the proceedings regardless of
whether a hearing was conducted. To
prevent potential confusion, proposed
§ 478.44(b) and (c) would replace
‘‘parties to the hearing’’ with ‘‘parties’’
so it is understood that they are parties
regardless of whether a hearing is
conducted. Because an attorney
adjudicator would have to determine
whether appeals assigned to him or her,
as proposed in section II.B above, meet
the amount in controversy requirement,
we also propose at § 478.44(a) and (b)
that an attorney adjudicator may
determine that the amount in
controversy, and may determine the
amount in controversy is less than $200
and notify the parties to submit
additional evidence to prove that the
amount in controversy is at least $200.
However, because we are not proposing
that an attorney adjudicator can dismiss
a request for an ALJ hearing because the
amount in controversy is not met,
proposed § 478.44(c) provides that an
ALJ would dismiss a request if at the
end of the 15-day period to submit
additional evidence to prove that the
amount in controversy is at least $200,
the ALJ determines that the amount in
controversy is less than $200.
We are inviting public comments on
these proposals. If you choose to
comment on the proposals in this
section, please include the caption
‘‘Determining the amount in
controversy’’ at the beginning of your
comment.
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4. Medicare Appeals Council and
Judicial Review (§ 478.46)
Current § 478.46(a) states that the
Council will review an ALJ’s hearing
decision or dismissal under the same
circumstances as those set forth at 20
CFR 404.970, which is now an outdated
reference to SSA Appeals Council
procedures for Council review. We are
proposing at § 478.46(a) to replace the
outdated reference to 20 CFR 404.970
with references to current §§ 405.1102
(‘‘Request for Council review when ALJ
or attorney adjudicator issued a decision
or dismissal’’) and 405.1110 (‘‘Council
reviews on its own motion’’). In
addition, we are proposing in
§ 478.46(a) and (b) to replace ‘‘hearing
decision’’ with ‘‘decision,’’ and ‘‘ALJ’’
with ‘‘ALJ or attorney adjudicator’’
because hearings are not always
conducted and a decision can generally
be appealed regardless of whether a
hearing was conducted, and attorney
adjudicators may issue decisions or
dismissals for which Council review
may be requested, as proposed in
section II.B above.
We are inviting public comments on
these proposals. If you choose to
comment on the proposals in this
section, please include the caption
‘‘Medicare Appeals Council and judicial
review’’ at the beginning of your
comment.
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5. Reopening and Revision of a
Reconsidered Determination or a
Decision (§ 478.48)
The title of current § 478.48 references
reopenings and revisions of
reconsidered determinations and
hearing decisions, and current § 478.48
has an outdated reference to subpart G
of 42 CFR part 405 for the procedures
for reopening a decision by an ALJ or
the Departmental Appeals Board.
We are proposing to revise the title of
§ 478.48 to replace ‘‘hearing decision’’
with ‘‘decision,’’ and in proposed
paragraphs (b) and (c) to replace ‘‘ALJ’’
with ‘‘ALJ or attorney adjudicator’’ so
the provision is understood to apply to
decisions by ALJs, regardless of whether
a hearing was conducted, or, as
proposed in section II.B above, attorney
adjudicators, as well as review
decisions, which are conducted by the
Medicare Appeals Council at the
Departmental Appeals Board. We also
propose at § 478.48(b) to replace the
outdated reference to § 405.750(b),
which was part of the now removed part
405, subpart G (77 FR 29016 through
29018), with § 405.980, which is the
current part 405, subpart I reopening
provision.
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We are inviting public comments on
these proposals. If you choose to
comment on the proposals in this
section, please include the caption
‘‘Reopening and revision of a
reconsidered determination or a
decision’’ at the beginning of your
comment.
IV. Collection of Information
Requirements
Under the Paperwork Reduction Act
of 1995 (PRA), we are required to
provide 60-day notice in the Federal
Register and solicit public comment
before a collection of information
requirement is submitted to the Office of
Management and Budget (OMB) for
review and approval. In order to fairly
evaluate whether an information
collection should be approved by OMB,
section 3506(c)(2)(A) of the PRA
requires that we solicit comment on the
following issues:
• The need for the information
collection and its usefulness in carrying
out the proper functions of our agency.
• The accuracy of our estimate of the
information collection burden.
• The quality, utility, and clarity of
the information to be collected.
• Recommendations to minimize the
information collection burden on the
affected public, including automated
collection techniques.
Therefore, we are soliciting public
comments on each of these issues for
the information collection requirements
discussed below.
The PRA exempts most of the
information collection activities
referenced in this proposed rule. In
particular, the implementing regulations
of the PRA at 5 CFR 1320.4 exclude
collection activities during the conduct
of a civil action to which the United
States or any official or agency thereof
is a party. Civil actions include
administrative actions such as
redeterminations, reconsiderations, and/
or appeals. Specifically, these actions
are taken after the initial determination
or a denial of payment, or MAO
organization determination or Part D
plan sponsor coverage determination.
However, one requirement contained in
this proposed rule is subject to the PRA
because the burden is imposed prior to
an administrative action or denial of
payment. This requirement is discussed
below.
In summary, we are proposing at
§ 405.910 that when a provider or
supplier is the party appointing a
representative, the appointment of
representation would include the
Medicare National Provider Identifier
(NPI) of the provider or supplier that
furnished the item of service. Although
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this is a new regulatory requirement, the
current Medicare Claims Processing
Manual already states that the NPI
should be included when a provider or
supplier appoints a representative. The
standardized form for appointing a
representative, Form CMS–1696,
currently provides a space for the
information in question. Importantly,
this form is currently approved under
OMB control number 0938–0950 and
expires June 30, 2018.
The burden associated with this
requirement is the time and effort of an
individual or entity who is a provider or
supplier to prepare an appointment of
representation containing the NPI. As
stated earlier, this requirement and the
related burden are subject to the PRA;
however, because we believe that this
information is already routinely being
collected, we estimate there would be
no additional burden for completing an
appointment of representative in
accordance with proposed 405.910.
If you wish to view the standardized
form and the supporting documentation,
you can download a copy from the CMS
Web site at https://www.cms.gov/
medicare/cms-forms/cms-forms/cmsforms-list.html.
We have submitted a copy of this
proposed rule to OMB for its review of
the information collection requirements
described above.
We are inviting public comment on
the burden associated with these
information collection requirements.
V. Response to Comments
Because of the large number of public
comments we normally receive on
Federal Register documents, we are not
able to acknowledge or respond to them
individually. We will consider all
comments we receive by the date and
time specified in the DATES section of
this proposed rule, and, when we
proceed with a subsequent document,
we will respond to the comments in the
preamble to that document.
VI. Regulatory Impact Statement
We have examined the impacts of this
proposed rule as required by Executive
Order 12866 on Regulatory Planning
and Review (September 30, 1993),
Executive Order 13563 on Improving
Regulation and Regulatory Review
(January 18, 2011), the Regulatory
Flexibility Act (RFA) (September 19,
1980, Pub. L. 96–354), section 1102(b) of
the Social Security Act, section 202 of
the Unfunded Mandates Reform Act of
1995 (March 22, 1995; Pub. L. 104–4),
Executive Order 13132 on Federalism
(August 4, 1999) and the Congressional
Review Act (5 U.S.C. 804(2)).
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Executive Orders 12866 and 13563
direct agencies to assess all costs and
benefits of available regulatory
alternatives and, if regulation is
necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
environmental, public health and safety
effects, distributive impacts, and
equity). A regulatory impact analysis
(RIA) must be prepared for major rules
with economically significant effects
($100 million or more in any 1 year). We
have determined that the effect of this
proposed rule does not reach this
economic threshold and thus is not
considered a major rule. As detailed
above, this proposed rule would only
make minimal changes to the existing
Medicare appeals procedures for claims
for benefits under or entitlement to the
original Medicare programs, and
coverage of items, services, and drugs
under the Medicare Advantage and
voluntary Medicare prescription drug
programs. Thus, this proposed rule
would have negligible financial impact
on beneficiaries and enrollees, providers
or suppliers, Medicare contractors,
MAOs, and Part D plan sponsors, but
would derive benefits to the program
and appellants.
HHS recognizes that the current
appeals backlog is a matter of great
significance, and it has made it a
priority to adopt measures that are
designed to reduce the backlog and
improve the overall Medicare appeals
process moving forward. To that end,
HHS has initiated a series of measures,
including this proposed regulation, that
are aimed at both reducing the backlog
and creating a more efficient Medicare
appeals system.
We believe the changes proposed in
this regulation will help address the
Medicare appeals backlog and create
efficiencies at the ALJ level of appeal by
allowing OMHA to reassign a portion of
workload to non-ALJ adjudicators,
reduce appeals of low-value claims, and
reduce procedural ambiguities that
result in unproductive efforts at OMHA
and unnecessary appeals to the
Medicare Appeals Council. In addition,
the other proposed changes, including
precedential decisions and generally
limiting CMS and CMS contractor
participation or party status at the
OMHA level unless the ALJ determines
participation by additional entities is
necessary for a full examination of the
matters at issue (as provided in
proposed §§ 405.1010(d) and
405.1012(d)), will collectively make the
ALJ hearing process more efficient
through streamlined and standardized
procedures and more consistent
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decisions, and reduce appeals to the
Medicare Appeals Council.
In particular, we are able to estimate
the impact from two of the proposed
modifications: proposals to expand the
pool of adjudicators and the
modifications to calculating the amount
in controversy (AIC) required for an ALJ
hearing. Based on FY 2015, and an
assumption that future years are similar
to FY 2015, we estimate that the
proposals to expand the pool of
adjudicators at OMHA could redirect
approximately 23,650 appeals per year
to attorney adjudicators to process these
appeals at a lower cost than would be
required if only ALJs were used to
address the same workload. If the
number of requests for hearing, waivers
of oral hearing, requests for review of a
contractor dismissal, or appellant
withdrawals of requests for hearing vary
from FY 2015 in future years then the
number of appeals potentially addressed
by attorney adjudicators would likely
also vary. Additionally, based on FY
2015 requests for an ALJ hearing, we
estimate that revising the calculation
methodology for the AIC required for an
ALJ hearing could remove appeals
related to over 2,600 Part B low-value
claims per year from the ALJ hearing
process, after accounting for the
likelihood of appellants aggregating
claims to meet the AIC. We also note
that appeals filed by Medicare
beneficiaries, and Medicare Advantage
and Part D prescription drug plan
enrollees would be minimally impacted
because they often appeal claim or
coverage denials for which they are
financially responsible, and for which
we would use the existing AIC
calculation methodology. We note that
this analysis is limited by the use of
only one fiscal year’s worth of data, and
that there is uncertainty in this estimate
as the number of appeals that would fall
under the revised AIC calculation may
vary from year to year.
The Regulatory Flexibility Act (5
U.S.C. 601 et seq.) (RFA) requires
agencies to prepare an initial regulatory
flexibility analysis to describe the
impact of the proposed rule on small
entities, unless the head of the agency
can certify that the rule would not have
a significant economic impact on a
substantial number of small entities.
The RFA generally defines a ‘‘small
entity’’ as: (1) A proprietary firm
meeting the size standards of the Small
Business Administration (SBA); (2) a
not-for-profit organization that is not
dominant in its field; or (3) a small
government jurisdiction with a
population of less than 50,000. States
and individuals are not included in the
definition of ‘‘small entity.’’ HHS uses
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as its measure of significant economic
impact on a substantial number of small
entities a change in revenues of more
than 3 to 5 percent.
For purposes of the RFA, most
providers and suppliers are small
entities, either by nonprofit status or by
having revenues of less than $7.5
million to $38.5 million in any one year.
In addition, a number of MAOs and Part
D plan sponsors (insurers) are small
entities due to their nonprofit status;
however, few if any meet the SBA size
standard for a small insurance firm by
having revenues of $38.5 million or less
in any one year. Individuals and States
are not included in the definition of a
small entity. We have determined and
we certify that this proposed rule would
not have a significant economic impact
on a substantial number of small entities
because as noted above, this proposed
rule if finalized would make only
minimal changes to the existing appeals
procedures. Therefore, we are not
preparing an analysis for the RFA.
In addition, section 1102(b) of the Act
requires us to prepare a regulatory
impact analysis (RIA) if a rule may have
a significant impact on the operations of
a substantial number of small rural
hospitals. For proposed rules, this
analysis must conform to the provisions
of section 603 of the RFA. For purposes
of section 1102(b) of the Act, we define
a small rural hospital as a hospital that
is located outside of a Metropolitan
Statistical Area for Medicare payment
regulations and has fewer than 100
beds. We have determined that this
proposed rule would not have a
significant effect on the operations of a
substantial number of small rural
hospitals. As noted above, this proposed
rule if finalized would make only
minimal changes to the existing appeals
procedures and thus, would not have a
significant impact on small entities or
the operations of a substantial number
of small rural hospitals. Therefore, we
are not preparing an analysis for section
1102(b) of the Act.
Section 202 of the Unfunded
Mandates Reform Act of 1995 also
requires that agencies assess anticipated
costs and benefits before issuing any
rule that would include any Federal
mandate that may result in expenditure
in any one year by State, local, or Tribal
governments, in the aggregate, or by the
private sector, of $100 million in 1995
dollars, updated annually for inflation.
Currently, that threshold is
approximately $146 million. This
proposed rule would not impose
spending costs on State, local, or tribal
governments in the aggregate, or on the
private sector in the amount of $146
million in any one year, because as
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Federal Register / Vol. 81, No. 128 / Tuesday, July 5, 2016 / Proposed Rules
PART 401—GENERAL
ADMINISTRATIVE REQUIREMENTS
Executive Order 13132 on Federalism
establishes certain requirements that an
agency must meet when it publishes a
proposed rule (and subsequent final
rule) that imposes substantial direct
requirement costs on State and local
governments, preempts State law, or
otherwise has Federalism implications.
This proposed rule would not impose
substantial direct requirement costs on
State or local governments, preempt
State law, or otherwise implicate
federalism.
In accordance with the provisions of
Executive Order 12866, this regulation
was reviewed by the Office of
Management and Budget.
List of Subjects
42 CFR Part 401
Claims, Freedom of information,
Health facilities, Medicare, Privacy.
42 CFR Part 405
Administrative practice and
procedure, Health facilities, Health
professions, Kidney diseases, Medical
devices, Medicare, Reporting and
recordkeeping requirements, Rural
areas, X-rays.
42 CFR Part 422
Administrative practice and
procedure, Health facilities, Health
maintenance organizations (HMO),
Medicare, Penalties, Privacy, and
Reporting and recordkeeping
requirements.
42 CFR Part 423
Administrative practice and
procedure, Emergency medical services,
Health facilities, Health maintenance
organizations (HMO), Health
professionals, Medicare, Penalties,
Privacy, Reporting and recordkeeping
requirements.
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42 CFR Part 478
Administrative practice and
procedure, Health care, Health
professions, Peer Review Organizations
(PRO), Reporting and recordkeeping
requirements.
For the reasons set forth in the
preamble, the Department of Health and
Human Services proposes to amend 42
CFR chapter IV as set forth below:
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■
■
VII. Federal Analysis
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1395kk, 1395rr and 1395ww(k)), and sec. 353
of the Public Health Service Act (42 U.S.C.
263a).
1. The authority citation for part 401
continues to read as follows:
noted above, this proposed rule if
finalized would make only minimal
changes to the existing appeals
procedures.
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Authority: Secs. 1102, 1871, and 1874(e)
of the Social Security Act (42 U.S.C. 1302,
1395hh, and 1395w–5).
2. Section 401.109 is added to read as
follows:
■
§ 401.109 Precedential Final Decisions of
the Secretary.
(a) The Chair of the Department of
Health and Human Services
Departmental Appeals Board may
designate a final decision of the
Secretary issued by the Medicare
Appeals Council in accordance with
part 405, subpart I; part 422, subpart M;
part 423, subpart U; or part 478, subpart
B, of this chapter as precedential.
(b) Precedential decisions are made
available to the public, with personally
identifiable information of the
beneficiary removed, and have
precedential effect from the date they
are made available to the public. Notice
of precedential decisions is published in
the Federal Register.
(c) Medicare Appeals Council
decisions designated in accordance with
paragraph (a) of this section have
precedential effect and are binding on
all CMS components, on all HHS
components that adjudicate matters
under the jurisdiction of CMS, and on
the Social Security Administration to
the extent that components of the Social
Security Administration adjudicate
matters under the jurisdiction of CMS.
(d) Precedential effect, as used in this
section, means that the Medicare
Appeals Council’s—
(1) Legal analysis and interpretation
of a Medicare authority or provision is
binding and must be followed in future
determinations and appeals in which
the same authority or provision applies
and is still in effect; and
(2) Factual findings are binding and
must be applied to future
determinations and appeals involving
the same parties if the relevant facts are
the same and evidence is presented that
the underlying factual circumstances
have not changed since the issuance of
the precedential final decision.
PART 405—FEDERAL HEALTH
INSURANCE FOR THE AGED AND
DISABLED
3. The authority citation for part 405
continues to read as follows:
■
Authority: Secs. 205(a), 1102, 1861,
1862(a), 1869, 1871, 1874, 1881, and 1886(k)
of the Social Security Act (42 U.S.C. 405(a),
1302, 1395x, 1395y(a), 1395ff, 1395hh,
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4. Section 405.902 is amended by
adding the definitions of ‘‘Attorney
Adjudicator’’, ‘‘Council’’, and ‘‘OMHA’’
in alphabetical order and removing the
definition of ‘‘MAC’’ to read as follows:
§ 405.902
Definitions.
*
*
*
*
*
Attorney Adjudicator means a
licensed attorney employed by OMHA
with knowledge of Medicare coverage
and payment laws and guidance, and
authorized to take the actions provided
for in this subpart on requests for ALJ
hearing and requests for reviews of QIC
dismissals.
*
*
*
*
*
Council stands for the Medicare
Appeals Council within the
Departmental Appeals Board of the U.S.
Department of Health and Human
Services.
*
*
*
*
*
OMHA stands for the Office of
Medicare Hearings and Appeals within
the U.S. Department of Health and
Human Services, which administers the
ALJ hearing process in accordance with
section 1869(b)(1) of the Act.
*
*
*
*
*
■ 5. Section 405.904 is amended by
revising paragraphs (a)(1) and (2) to read
as follows:
§ 405.904 Medicare initial determinations,
redeterminations and appeals: General
description.
(a) * * *
(1) Entitlement appeals. The SSA
makes an initial determination on an
application for Medicare benefits and/or
entitlement of an individual to receive
Medicare benefits. A beneficiary who is
dissatisfied with the initial
determination may request, and SSA
will perform, a reconsideration in
accordance with 20 CFR part 404,
subpart J if the requirements for
obtaining a reconsideration are met.
Following the reconsideration, the
beneficiary may request a hearing before
an Administrative Law Judge (ALJ)
under this subpart (42 CFR part 405,
subpart I). If the beneficiary obtains a
hearing before an ALJ and is dissatisfied
with the decision of the ALJ, or if the
beneficiary requests a hearing and no
hearing is conducted, and the
beneficiary is dissatisfied with the
decision of an ALJ or an attorney
adjudicator, he or she may request the
Medicare Appeals Council (Council) to
review the case. Following the action of
the Council, the beneficiary may be
entitled to file suit in Federal district
court.
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(2) Claim appeals. The Medicare
contractor makes an initial
determination when a claim for
Medicare benefits under Part A or Part
B is submitted. A beneficiary who is
dissatisfied with the initial
determination may request that the
contractor perform a redetermination of
the claim if the requirements for
obtaining a redetermination are met.
Following the contractor’s
redetermination, the beneficiary may
request, and the Qualified Independent
Contractor (QIC) will perform, a
reconsideration of the claim if the
requirements for obtaining a
reconsideration are met. Following the
reconsideration, the beneficiary may
request a hearing before an ALJ. If the
beneficiary obtains a hearing before the
ALJ and is dissatisfied with the decision
of the ALJ, or if the beneficiary requests
a hearing and no hearing is conducted,
and the beneficiary is dissatisfied with
the decision of an ALJ or attorney
adjudicator, he or she may request the
Council to review the case. If the
Council reviews the case and issues a
decision, and the beneficiary is
dissatisfied with the decision, the
beneficiary may file suit in Federal
district court if the amount remaining in
controversy and the other requirements
for judicial review are met.
*
*
*
*
*
§ 405.906
[Amended]
6. Section 405.906(b) introductory text
is amended by—
■ a. Removing from the paragraph
heading the phrase ‘‘hearing and MAC’’
and adding ‘‘proceedings on a request
for hearing, and Council review’’ in its
place.
■ b. Removing the phrase ‘‘hearing, and
MAC review’’ and adding ‘‘proceedings
on a request for hearing, and Council
review’’ in its place.
■
§ 405.908
[Amended]
7. Section 405.908 is amended by—
a. Removing the term ‘‘ALJ’’ and
adding ‘‘OMHA’’ in its place.
■ b. Removing the term ‘‘MAC’’ and
adding ‘‘Council’’ in its place.
■ 8. Section 405.910 is amended by—
■ a. Revising paragraph (c)(5).
■ b. Adding paragraph (d)(3).
■ c. Revising paragraphs (f)(1), (i)(2),
and (3).
■ d. Revising paragraph (l).
■ e. Adding paragraph (m)(4).
The additions and revisions read as
follows:
sradovich on DSK3GDR082PROD with PROPOSALS3
■
■
§ 405.910
Appointed representatives.
*
*
*
*
*
(c) * * *
(5) Identify the beneficiary’s Medicare
health insurance claim number when
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the beneficiary is the party appointing a
representative, or identify the Medicare
National Provider Identifier number of
the provider or supplier that furnished
the item or service when the provider or
supplier is the party appointing a
representative;
*
*
*
*
*
(d) * * *
(3) If an adjudication time frame
applies, the time from the later of the
date that a defective appointment of
representative was filed or the current
appeal request was filed by the
prospective appointed representative, to
the date when the defect was cured or
the party notifies the adjudicator that he
or she will proceed with the appeal
without a representative does not count
towards the adjudication time frame.
*
*
*
*
*
(f) * * *
(1) General rule. An appointed
representative for a beneficiary who
wishes to charge a fee for services
rendered in connection with an appeal
before the Secretary must obtain
approval of the fee from the Secretary.
Services rendered below the OMHA
level are not considered proceedings
before the Secretary.
*
*
*
*
*
(i) * * *
(2) Appeals. When a contractor, QIC,
ALJ or attorney adjudicator, or the
Council takes an action or issues a
redetermination, reconsideration, or
appeal decision, in connection with an
initial determination, it sends notice of
the action to the appointed
representative.
(3) The contractor, QIC, ALJ or
attorney adjudicator, or Council sends
any requests for information or evidence
regarding a claim that is appealed to the
appointed representative. The
contractor sends any requests for
information or evidence regarding an
initial determination to the party.
*
*
*
*
*
(l) Delegation of appointment by
appointed representative. (1) An
appointed representative may not
designate another individual to act as
the appointed representative of the
party unless—
(i) The appointed representative
provides written notice to the party of
the appointed representative’s intent to
delegate to another individual, which
contains the name of the designee and
the designee’s acceptance to be
obligated by and comply with the
requirements of representation under
this subpart; and
(ii) The party accepts the designation
as evidenced by a written statement
signed by the party. The written
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statement signed by the party is not
required when the appointed
representative and designee are
attorneys in the same law firm or
organization and the notice described in
paragraph (l)(1)(i) of this section so
indicates.
(2) A delegation is not effective until
the adjudicator receives a copy of the
acceptance described in paragraph
(l)(1)(ii) of this section, unless the
appointed representative and designee
are attorneys in the same law firm or
organization, in which case the notice
described in paragraph (l)(1)(i) of this
section may be submitted even though
the acceptance described in paragraph
(l)(1)(ii) of this section is not required.
(3) A party’s or representative’s failure
to notify the adjudicator that an
appointment of representative has been
delegated is not good cause for missing
a deadline or not appearing at a hearing.
(m) * * *
(4) A party’s or representative’s failure
to notify the adjudicator that an
appointment of representative has been
revoked is not good cause for missing a
deadline or not appearing at a hearing.
■ 9. Section 405.926 is amended by
revising paragraphs (l) and (m) to read
as follows:
§ 405.926 Actions that are not initial
determinations.
*
*
*
*
*
(l) A contractor’s, QIC’s, ALJ’s or
attorney adjudicator’s, or Council’s
determination or decision to reopen or
not to reopen an initial determination,
redetermination, reconsideration,
decision, or review decision.
(m) Determinations that CMS or its
contractors may participate in the
proceedings on a request for an ALJ
hearing or act as parties in an ALJ
hearing or Council review.
*
*
*
*
*
§ 405.956
[Amended]
10. Section 405.956(b)(8) is amended
by removing the phrase ‘‘an ALJ
hearing’’ and adding ‘‘the OMHA level’’
in its place.
■ 11. Section 405.968 is amended by
revising paragraph (b)(1) to read as
follows:
■
§ 405.968
Conduct of a reconsideration.
*
*
*
*
*
(b) * * *
(1) National coverage determinations
(NCDs), CMS Rulings, Council decisions
designated by the Chair of the
Departmental Appeals Board as having
precedential effect under § 401.109 of
this chapter, and applicable laws and
regulations are binding on the QIC.
*
*
*
*
*
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Federal Register / Vol. 81, No. 128 / Tuesday, July 5, 2016 / Proposed Rules
12. Section 405.970 is amended by
revising the section heading and
paragraphs (a) introductory text, (b), (c)
introductory text, (e)(1), (e)(2)(i) and (ii)
to read as follows:
■
sradovich on DSK3GDR082PROD with PROPOSALS3
§ 405.970 Timeframe for making a
reconsideration following a contractor
redetermination.
(a) General rule. Within 60 calendar
days of the date the QIC receives a
timely filed request for reconsideration
following a contractor redetermination
or any additional time provided by
paragraph (b) of this section, the QIC
mails, or otherwise transmits to the
parties at their last known addresses,
written notice of—
*
*
*
*
*
(b) Exceptions. (1) If a QIC grants an
appellant’s request for an extension of
the 180 calendar day filing deadline
made in accordance with § 405.962(b),
the QIC’s 60 calendar day decisionmaking timeframe begins on the date the
QIC receives the late filed request for
reconsideration following a contractor
redetermination, or when the request for
an extension that meets the
requirements of § 405.962(b) is granted,
whichever is later.
(2) If a QIC receives timely requests
for reconsideration following a
contractor redetermination from
multiple parties, consistent with
§ 405.964(c), the QIC must issue a
reconsideration, notice that it cannot
complete its review, or dismissal within
60 calendar days for each submission of
the latest filed request.
(3) Each time a party submits
additional evidence after the request for
reconsideration following a contractor
redetermination is filed, the QIC’s 60
calendar day decisionmaking timeframe
is extended by up to 14 calendar days
for each submission, consistent with
§ 405.966(b).
(c) Responsibilities of the QIC. Within
60 calendar days of receiving a request
for a reconsideration following a
contractor redetermination, or any
additional time provided for under
paragraph (b) of this section, a QIC must
take one of the following actions:
*
*
*
*
*
(e) * * *
(1) If the appellant fails to notify the
QIC, or notifies the QIC that the
appellant does not choose to escalate
the case, the QIC completes its
reconsideration following a contractor
redetermination and notifies the
appellant of its action consistent with
§ 405.972 or § 405.976.
(2) * * *
(i) Complete its reconsideration
following a contractor redetermination
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and notify all parties of its decision
consistent with § 405.972 or § 405.976.
(ii) Acknowledge the escalation notice
in writing and forward the case file to
OMHA.
■ 13. Section 405.972 is amended by—
■ a. Revising the section heading.
■ b. Amending paragraph (b)(3) by
removing the phrase ‘‘reconsideration of
a contractor’s dismissal’’ and adding
‘‘review of a contractor’s dismissal’’ in
its place.
■ c. Amending paragraph (e) by adding
the phrase ‘‘or attorney adjudicator’’
after the phrase ‘‘modified or reversed
by an ALJ’’ and removing the phrase
‘‘reconsideration of a contractor’s
dismissal’’ and adding ‘‘review of a
contractor’s dismissal’’ in its place.
The revision reads as follows:
§ 405.972 Withdrawal or dismissal of a
request for reconsideration or review of a
contractor’s dismissal of a request for
redetermination.
*
*
*
*
*
14. Section 405.974 is amended by—
a. Revising the section heading.
b. Amending the heading to paragraph
(b) by removing the phrase
‘‘Reconsideration of contractor’s’’ and
adding ‘‘Review of a contractor’s’’ in its
place.
■ c. Amending paragraph (b)(3) by
removing the word ‘‘reconsideration’’
and adding ‘‘review’’ in its place.
The revision reads as follows:
■
■
■
§ 405.974 Reconsideration and review of a
contractor’s dismissal of a request for
redetermination.
*
*
*
*
*
15. Section 405.976 is amended by—
a. Amending paragraph (b)(5)(ii) by
removing the phrase ‘‘at an ALJ level, or
made part of the administrative record’’
and adding ‘‘at the OMHA level’’ in its
place.
■ b. Revising paragraph (b)(7) to read as
follows:
■
■
§ 405.976
Notice of a reconsideration.
*
*
*
*
*
(b) * * *
(7) A statement of whether the
amount in controversy is estimated to
meet or not meet the amount required
for an ALJ hearing, if—
(i) The request for reconsideration
was filed by a beneficiary who is not
represented by a provider, supplier, or
Medicaid State agency; and
(ii) The reconsideration decision is
partially or fully unfavorable.
*
*
*
*
*
§ 405.978
[Amended]
16. Section 405.978(a) is amended by
removing the phrase ‘‘An ALJ decision’’
■
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43859
and adding ‘‘An ALJ or attorney
adjudicator decision’’ in its place.
■ 17. Section 405.980 is amended by
revising the section heading and
paragraphs (a)(1)(iii) and (iv), (a)(4) and
(5), (d) paragraph heading, (d)(2) and
(3), (e) paragraph heading, and (e)(2)
and (3) to read as follows:
§ 405.980 Reopening of initial
determinations, redeterminations,
reconsiderations, decisions, and reviews.
(a) * * *
(1) * * *
(iii) An ALJ or attorney adjudicator to
revise his or her decision; or
(iv) The Council to revise the ALJ or
attorney adjudicator decision, or its
review decision.
*
*
*
*
*
(4) When a party has filed a valid
request for an appeal of an initial
determination, redetermination,
reconsideration, ALJ or attorney
adjudicator decision, or Council review,
no adjudicator has jurisdiction to
reopen an issue on a claim that is under
appeal until all appeal rights for that
issue are exhausted. Once the appeal
rights for the issue have been exhausted,
the contractor, QIC, ALJ or attorney
adjudicator, or Council may reopen as
set forth in this section.
(5) The contractor’s, QIC’s, ALJ’s or
attorney adjudicator’s, or Council’s
decision on whether to reopen is
binding and not subject to appeal.
*
*
*
*
*
(d) Time frame and requirements for
reopening reconsiderations, decisions
and reviews initiated by a QIC, ALJ or
attorney adjudicator, or the Council.
*
*
*
*
*
(2) An ALJ or attorney adjudicator
may reopen his or her decision, or the
Council may reopen an ALJ or attorney
adjudicator decision on its own motion
within 180 calendar days from the date
of the decision for good cause in
accordance with § 405.986. If the
decision was procured by fraud or
similar fault, then the ALJ or attorney
adjudicator may reopen his or her
decision, or the Council may reopen an
ALJ or attorney adjudicator decision, at
any time.
(3) The Council may reopen its review
decision on its own motion within 180
calendar days from the date of the
review decision for good cause in
accordance with § 405.986. If the
Council’s decision was procured by
fraud or similar fault, then the Council
may reopen at any time.
(e) Time frames and requirements for
reopening reconsiderations, decisions,
and reviews requested by a party.
*
*
*
*
*
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(2) A party to an ALJ or attorney
adjudicator decision may request that an
ALJ or attorney adjudicator reopen his
or her decision, or the Council reopen
an ALJ or attorney adjudicator decision,
within 180 calendar days from the date
of the decision for good cause in
accordance with § 405.986.
(3) A party to a Council review may
request that the Council reopen its
decision within 180 calendar days from
the date of the review decision for good
cause in accordance with § 405.986.
§ 405.982
[Amended]
18. Section 405.982(a) and (b) are
amended by removing the phrase ‘‘ALJ,
or the MAC’’ and adding the phrase
‘‘ALJ or attorney adjudicator, or the
Council’’ in its place.
■ 19. Section 405.984 is amended by—
■ a. Amending paragraph (c) by
removing the phrase ‘‘in accordance
with § 405.1000 through § 405.1064’’
and adding ‘‘in accordance with
§ 405.1000 through § 405.1063’’ in its
place.
■ b. Revising paragraphs (d) and (e) to
read as follows:
■
§ 405.984 Effect of a revised determination
or decision.
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*
*
*
*
*
(d) ALJ or attorney adjudicator
decisions. The revision of an ALJ or
attorney adjudicator decision is binding
upon all parties unless a party files a
written request for a Council review that
is accepted and processed in accordance
with § 405.1100 through § 405.1130.
(e) Council review. The revision of a
Council review is binding upon all
parties unless a party files a civil action
in which a Federal district court accepts
jurisdiction and issues a decision.
*
*
*
*
*
■ 20. Section 405.990 is amended by—
■ a. Amending paragraph (a)(2) by
removing the phrase ‘‘Medicare Appeals
Council (MAC)’’ and adding the term
‘‘Council’’ in its place.
■ b. Amending paragraphs (b)(1)
introductory text, (b)(1)(i)(B), (b)(4), and
(d)(2)(ii) by removing the term ‘‘MAC’’
each time it appears and adding
‘‘Council’’ in its place.
■ c. Amending paragraph (b)(1)(i)(A) by
removing the phrase ‘‘the ALJ has’’ and
adding ‘‘the ALJ or attorney adjudicator
has’’ in its place.
■ d. Amending paragraph (b)(1)(ii) by
removing the phrase ‘‘to the ALJ level’’
and adding ‘‘to OMHA for an ALJ
hearing’’ in its place.
■ e. Amending paragraphs (c)(3), (4),
and (5) by removing the term ‘‘ALJ
hearing decision’’ and adding ‘‘ALJ or
attorney adjudicator decision’’ in its
place.
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h. Revising paragraph (d)(1).
i. Amending paragraph (d)(2)(i) by
removing the term ‘‘ALJ’s’’ and adding
‘‘ALJ’s or attorney adjudicator’s’’ in its
place.
■ j. Amending paragraph (d)(2)(ii) by
removing the term ‘‘MAC’s’’ and adding
‘‘Council’s’’ in its place.
■ k. Revising paragraphs (i)(1) and (2).
The revisions read as follows:
■
■
§ 405.990
review.
Expedited access to judicial
*
*
*
*
*
(d) * * *
(1) Method and place for filing
request. The requestor may—
(i) If a request for ALJ hearing or
Council review is not pending, file a
written EAJR request with the HHS
Departmental Appeals Board with his or
her request for an ALJ hearing or
Council review; or
(ii) If an appeal is already pending for
an ALJ hearing or otherwise before
OMHA, or the Council, file a written
EAJR request with the HHS
Departmental Appeals Board.
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(i) * * *
(1) If a request for EAJR does not meet
all the conditions set out in paragraphs
(b), (c) and (d) of this section, or if the
review entity does not certify a request
for EAJR, the review entity advises in
writing all parties that the request has
been denied, and forwards the request
to OMHA or the Council, which will
treat it as a request for hearing or for
Council review, as appropriate.
(2) Whenever a review entity forwards
a rejected EAJR request to OMHA or the
Council, the appeal is considered timely
filed, and if an adjudication time frame
applies to the appeal, the adjudication
time frame begins on the day the request
is received by OMHA or the Council
from the review entity.
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■ 21. Section 405.1000 is revised to read
as follows:
§ 405.1000 Hearing before an ALJ and
decision by an ALJ or attorney adjudicator:
General rule.
(a) If a party is dissatisfied with a
QIC’s reconsideration, or if the
adjudication period specified in
§ 405.970 for the QIC to complete its
reconsideration has elapsed, the party
may request a hearing before an ALJ.
(b) A hearing before an ALJ may be
conducted in-person, by videoteleconference (VTC), or by telephone.
At the hearing, the parties may submit
evidence (subject to the restrictions in
§ 405.1018 and § 405.1028), examine the
evidence used in making the
determination under review, and
present and/or question witnesses.
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(c) In some circumstances, CMS or its
contractor may participate in the
proceedings under § 405.1010, or join
the hearing before an ALJ as a party
under § 405.1012.
(d) The ALJ or attorney adjudicator
conducts a de novo review and issues a
decision based on the administrative
record, including, for an ALJ, any
hearing record.
(e) If all parties who are due a notice
of hearing in accordance with
§ 405.1020(c) waive their right to appear
at the hearing in person or by telephone
or video-teleconference, the ALJ or an
attorney adjudicator may make a
decision based on the evidence that is
in the file and any new evidence that is
submitted for consideration.
(f) The ALJ may require the parties to
participate in a hearing if it is necessary
to decide the case. If the ALJ determines
that it is necessary to obtain testimony
from a non-party, he or she may hold a
hearing to obtain that testimony, even if
all of the parties who are entitled to a
notice of hearing in accordance with
§ 405.1020(c) have waived the right to
appear. In that event, however, the ALJ
will give the parties the opportunity to
appear when the testimony is given, but
may hold the hearing even if none of the
parties decide to appear.
(g) An ALJ or attorney adjudicator
may also issue a decision on the record
on his or her own initiative if the
evidence in the administrative record
supports a fully favorable finding for the
appellant, and there is no other party or
no other party is entitled to a notice of
hearing in accordance with
§ 405.1020(c).
(h) If more than one party timely files
a request for hearing on the same claim
before a decision is made on the first
timely filed request, the requests are
consolidated into one proceeding and
record, and one decision, dismissal, or
remand is issued.
§ 405.1002
[Amended]
22. Section 405.1002 is amended by—
a. Amending paragraph (a)
introductory text by removing the
phrase ‘‘may request’’ and adding ‘‘has
a right to’’ in its place
■ b. Amending paragraph (a)(4) by
removing the word ‘‘entity’’ and adding
‘‘office’’ in its place.
■ c. Amending paragraph (b)(1) by
removing the phrase ‘‘to the ALJ level’’
and adding ‘‘for a hearing before an
ALJ’’ in its place.
■ 23. Section 405.1004 is amended by—
■ a. Revising the section heading and
paragraphs (a) introductory text, (a)(1)
and (4), (b), and (c).
■ b. Adding paragraph (d).
The revisions and addition read as
follows:
■
■
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§ 405.1004 Right to a review of QIC notice
of dismissal.
(a) A party to a QIC’s dismissal of a
request for reconsideration has a right to
have the dismissal reviewed by an ALJ
or attorney adjudicator if—
(1) The party files a written request
for review within 60 calendar days after
receipt of the notice of the QIC’s
dismissal.
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(4) For purposes of meeting the 60
calendar day filing deadline, the request
is considered as filed on the date it is
received by the office specified in the
QIC’s dismissal.
(b) If the ALJ or attorney adjudicator
determines that the QIC’s dismissal was
in error, he or she vacates the dismissal
and remands the case to the QIC for a
reconsideration in accordance with
§ 405.1056.
(c) If the ALJ or attorney adjudicator
affirms the QIC’s dismissal of a
reconsideration request, he or she issues
a notice of decision affirming the QIC
dismissal in accordance with
§ 405.1046(b).
(d) The ALJ or attorney adjudicator
may dismiss the request for review of a
QIC’s dismissal in accordance with
§ 405.1052(b).
■ 24. Section 405.1006 is amended by—
■ a. Revising the section heading and
paragraphs (d)(1) introductory text,
(d)(1)(ii), and (d)(2).
■ b. Adding paragraphs (d)(3) through
(7).
■ c. Revising paragraphs (e)(1)
introductory text, (e)(1)(ii) and (iii),
(e)(2) introductory text, and (e)(2)(ii)
and (iii).
The revisions and additions read as
follows:
§ 405.1006 Amount in controversy
required for an ALJ hearing and judicial
review.
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(d) * * *
(1) In general. In situations other than
those described in paragraphs (d)(3)
through (7) of this section, the amount
remaining in controversy is computed
as the basis for the amount in
controversy for the items and services in
the disputed claim, as defined in
paragraph (d)(2) of this section, reduced
by—
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(ii) Any deductible and/or
coinsurance amounts that may be
collected for the items or services.
(2) Basis for the amount in
controversy. For purposes of calculating
the amount in controversy under
paragraph (d)(1) of this section, the basis
for the amount in controversy is defined
as follows:
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(i) General rule. For situations other
than those described in paragraphs
(d)(2)(ii) and (iii) of this section, the
basis for the amount in controversy is
determined as follows:
(A) For items and services with a
published Medicare fee schedule or
published contractor-priced amount, the
basis for the amount in controversy is
the allowable amount, which is the
amount reflected on the fee schedule or
in the contractor-priced amount for
those items or services in the applicable
jurisdiction and place of service.
(B) For items and services with no
published Medicare fee schedule or
published contractor-priced amount, the
basis for the amount in controversy is
the billed charges submitted on the
claim for those items or services.
(ii) Beneficiary financial
responsibility. For items and services for
which a beneficiary has been
determined to be financially
responsible, the basis for the amount in
controversy is the actual amount
charged to the beneficiary (or the
maximum amount the beneficiary may
be charged if no bill has been received)
for the items and services in the
disputed claim.
(iii) Refunds of amounts previously
collected. If a beneficiary received or
may be entitled to a refund of the
amount the beneficiary previously paid
to the provider or supplier for the items
or services in the disputed claim under
applicable statutory or regulatory
authority, the basis for the amount in
controversy is the actual amount
originally charged to the beneficiary for
those items or services.
(3) Limitation on liability. When
payment is made for items or services
under section 1879 of the Act or
§ 411.400 of this chapter, or the liability
of the beneficiary for those services is
limited under § 411.402 of this chapter,
the amount in controversy is calculated
in accordance with paragraphs (d)(1)
and (d)(2)(i) of this section, except there
is no deduction under paragraph
(d)(1)(i) for expenses that are paid under
§ 411.400 of this chapter or as a result
of liability that is limited under
§ 411.402 of this chapter.
(4) Item or service terminations. When
a matter involves a provider or supplier
termination of Medicare-covered items
or services that is disputed by a
beneficiary, and the beneficiary did not
elect to continue receiving the items or
services, the amount in controversy is
calculated in accordance with
paragraphs (d)(1) and (d)(2)(ii) of this
section, except that the basis for the
amount in controversy and any
deductible and coinsurance that may be
collected for the items or services are
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calculated using the amount the
beneficiary would have been charged if
the beneficiary had received the items
or services the beneficiary asserts
should have been covered based on the
beneficiary’s current condition, and
Medicare payment were not made for
the items or services.
(5) Overpayments. Notwithstanding
paragraphs (d)(1) and (2) of this section,
when an appeal involves an identified
overpayment, the amount in controversy
is the amount of the overpayment
specified in the demand letter for the
items or services in the disputed claim.
When an appeal involves an estimated
overpayment amount determined
through the use of statistical sampling
and extrapolation, the amount in
controversy is the total amount of the
estimated overpayment determined
through extrapolation, as specified in
the demand letter.
(6) Coinsurance and deductible
challenges. Notwithstanding paragraphs
(d)(1) and (2) of this section, for appeals
filed by beneficiaries challenging only
the computation of a coinsurance
amount or the amount of a remaining
deductible, the amount in controversy is
the difference between the amount of
the coinsurance or remaining
deductible, as determined by the
contractor, and the amount of the
coinsurance or remaining deductible the
beneficiary believes is correct.
(7) Fee schedule or contractor price
challenges. Notwithstanding paragraphs
(d)(1) and (2) of this section, for appeals
of claims where the allowable amount
has been paid in full and the appellant
is challenging only the validity of the
allowable amount, as reflected on the
published fee schedule or in the
published contractor-priced amount
applicable to the items or services in the
disputed claim, the amount in
controversy is the difference between
the amount the appellant argues should
have been the allowable amount for the
items or services in the disputed claim
in the applicable jurisdiction and place
of service, and the published allowable
amount for the items or services.
(e) * * *
(1) Aggregating claims in appeals of
QIC reconsiderations for an ALJ hearing.
Either an individual appellant or
multiple appellants may aggregate two
or more claims to meet the amount in
controversy for an ALJ hearing if—
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(ii) The appellant(s) requests
aggregation of claims appealed in the
same request for ALJ hearing, or in
multiple requests for an ALJ hearing
filed with the same request for
aggregation, and the request is filed
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within 60 calendar days after receipt of
all of the reconsiderations being
appealed; and
(iii) The claims that a single appellant
seeks to aggregate involve the delivery
of similar or related services, or the
claims that multiple appellants seek to
aggregate involve common issues of law
and fact, as determined by an ALJ or
attorney adjudicator. Only an ALJ may
determine the claims that a single
appellant seeks to aggregate do not
involve the delivery of similar or related
services, or the claims that multiple
appellants seek to aggregate do not
involve common issues of law and fact.
Part A and Part B claims may be
combined to meet the amount in
controversy requirements.
(2) Aggregating claims that are
escalated from the QIC level for an ALJ
hearing. Either an individual appellant
or multiple appellants may aggregate
two or more claims to meet the amount
in controversy for an ALJ hearing if—
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(ii) The appellant(s) requests
aggregation of the claims for an ALJ
hearing in the same request for
escalation; and
(iii) The claims that a single appellant
seeks to aggregate involve the delivery
of similar or related services, or the
claims that multiple appellants seek to
aggregate involve common issues of law
and fact, as determined by an ALJ or
attorney adjudicator. Only an ALJ may
determine the claims that a single
appellant seeks to aggregate do not
involve the delivery of similar or related
services, or the claims that multiple
appellants seek to aggregate do not
involve common issues of law and fact.
Part A and Part B claims may be
combined to meet the amount in
controversy requirements.
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■ 25. Section 405.1008 is revised to read
as follows:
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§ 405.1008 Parties to the proceedings on a
request for an ALJ hearing.
The party who filed the request for
hearing and all other parties to the
reconsideration are parties to the
proceedings on a request for an ALJ
hearing. In addition, a representative of
CMS or its contractor may be a party
under the circumstances described in
§ 405.1012.
■ 26. Section 405.1010 is revised to read
as follows:
§ 405.1010 When CMS or its contractors
may participate in the proceedings on a
request for an ALJ hearing.
(a) When CMS or a contractor can
participate. (1) CMS or its contractors
may elect to participate in the
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proceedings on a request for an ALJ
hearing upon filing a notice of intent to
participate in accordance with
paragraph (b) of this section.
(2) An ALJ may request, but may not
require, CMS and/or one or more of its
contractors to participate in any
proceedings before the ALJ, including
the oral hearing, if any. The ALJ cannot
draw any adverse inferences if CMS or
the contractor decides not to participate
in any proceedings before the ALJ,
including the hearing.
(b) How an election is made. (1) No
notice of hearing. If CMS or a contractor
elects to participate before receipt of a
notice of hearing, or when a notice of
hearing is not required, it must send
written notice of its intent to participate
to the assigned ALJ or attorney
adjudicator, or a designee of the Chief
ALJ if the request for hearing is not yet
assigned to an ALJ or attorney
adjudicator, and the parties who were
sent a copy of the notice of
reconsideration.
(2) Notice of hearing. If CMS or a
contractor elects to participate after
receipt of a notice of hearing, it must
send written notice of its intent to
participate to the ALJ and the parties
who were sent a copy of the notice of
hearing.
(3) Timing of election. CMS or a
contractor must send its notice of intent
to participate—
(i) If no hearing is scheduled, no later
than 30 calendar days after notification
that a request for hearing was filed; or
(ii) If a hearing is scheduled, no later
than 10 calendar days after receiving the
notice of hearing.
(c) Roles and responsibilities of CMS
or a contractor as a participant. (1)
Subject to paragraphs (d)(1) through
(d)(3) of this section, participation may
include filing position papers and/or
providing testimony to clarify factual or
policy issues in a case, but it does not
include calling witnesses or crossexamining the witnesses of a party to
the hearing.
(2) When CMS or its contractor
participates in an ALJ hearing, CMS or
its contractor may not be called as a
witness during the hearing and is not
subject to examination or crossexamination by the parties. However,
the parties may provide testimony to
rebut factual or policy statements made
by a participant and the ALJ may
question the participant about its
testimony.
(3) CMS or contractor position papers
and written testimony are subject to the
following:
(i) A position paper or written
testimony must be submitted by within
14 calendar days of an election to
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participate if no hearing has been
scheduled, or no later than 5 calendar
days prior to the hearing if a hearing is
scheduled unless the ALJ grants
additional time to submit the position
paper or written testimony.
(ii) A copy of any position paper or
written testimony it submits to OMHA
must be sent to—
(A) The parties who were sent a copy
of the notice of reconsideration, if the
position paper or written testimony is
being submitted before receipt of a
notice of hearing for the appeal; or
(B) The parties who were sent a copy
of the notice of hearing, if the position
paper or written testimony is being
submitted after receipt of a notice of
hearing for the appeal.
(iii) If CMS or a contractor fails to
send a copy of its position paper or
written testimony to the parties or fails
to submit its position paper or written
testimony within the time frames
described in this paragraph, the position
paper or written testimony will not be
considered in deciding the appeal.
(d) Limitation on participating in a
hearing. (1) If CMS or a contractor has
been made a party to a hearing in
accordance with § 405.1012, no entity
that elected to be a participant in the
proceedings in accordance with this
section (or that elected to be a party to
the hearing but was made a participant
in accordance with § 405.1012(d)(1))
may participate in the oral hearing, but
such entity may file a position paper
and/or written testimony to clarify
factual or policy issues in the case.
(2) If CMS or a contractor did not elect
to be a party to a hearing in accordance
with § 405.1012 and more than one
entity elected to be a participant in the
proceedings in accordance with this
section, only the first entity to file a
response to the notice of hearing as
provided under § 405.1020(c) may
participate in the oral hearing. Entities
that filed a subsequent response to the
notice of hearing may not participate in
the oral hearing, but may file a position
paper and/or written testimony to
clarify factual or policy issues in the
case.
(3) If CMS or a contractor is precluded
from participating in the oral hearing
under paragraph (d)(1) or (2) of this
section, the ALJ may grant leave to the
precluded entity to participate in the
oral hearing if the ALJ determines that
the entity’s participation is necessary for
a full examination of the matters at
issue.
(e) Invalid election. (1) An ALJ or
attorney adjudicator may determine that
a CMS or contractor election is invalid
under this section if the election was
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not timely filed or the election was not
sent to the correct parties.
(2) If an election is determined to be
invalid, a written notice must be sent to
the entity that submitted the election
and the parties who are entitled to
receive notice of the election in
accordance with this section.
(i) If no hearing is scheduled or the
election was submitted after the hearing
occurred, the written notice of invalid
election must be sent no later than the
date the notice of decision, dismissal, or
remand is mailed.
(ii) If a hearing is scheduled, the
written notice of invalid election must
be sent prior to the hearing. If the notice
would be sent fewer than 5 calendar
days before the hearing is scheduled to
occur, oral notice must be provided to
the entity that submitted the election,
and the written notice must be sent as
soon as possible after the oral notice is
provided.
■ 27. Section 405.1012 is revised to read
as follows:
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§ 405.1012 When CMS or its contractors
may be a party to a hearing.
(a) When CMS or a contractor can
elect to be a party to a hearing. (1)
Unless the request for hearing is filed by
an unrepresented beneficiary, and
unless otherwise provided in this
section, CMS or one of its contractors
may elect to be a party to the hearing
upon filing a notice of intent to be a
party to the hearing in accordance with
paragraph (b) of this section no later
than 10 calendar days after the QIC
receives the notice of hearing.
(2) An ALJ may request, but may not
require, CMS and/or one or more of its
contractors to be a party to the hearing.
The ALJ cannot draw any adverse
inferences if CMS or the contractor
decides not to be a party to the hearing.
(b) How an election is made. If CMS
or a contractor elects to be a party to the
hearing, it must send written notice to
the ALJ and the parties identified in the
notice of hearing of its intent to be a
party to the hearing.
(c) Roles and responsibilities of CMS
or a contractor as a party. (1) As a party,
CMS or a contractor may file position
papers, submit evidence, provide
testimony to clarify factual or policy
issues, call witnesses or cross-examine
the witnesses of other parties.
(2) CMS or contractor position papers,
written testimony, and evidentiary
submissions are subject to the following:
(i) Any position paper, written
testimony, and/or evidence must be
submitted no later than 5 calendar days
prior to the hearing unless the ALJ
grants additional time to submit the
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position paper, written testimony, and/
or evidence.
(ii) A copy of any position paper,
written testimony, and/or evidence it
submits to OMHA must be sent to the
parties who were sent a copy of the
notice of hearing.
(iii) If CMS or a contractor fails to
send a copy of its position paper,
written testimony, and/or evidence to
the parties or fails to submit its position
paper, written testimony, and/or
evidence within the time frames
described in this section, the position
paper, written testimony, and/or
evidence will not be considered in
deciding the appeal.
(d) Limitation on participating in a
hearing. (1) If CMS and one or more
contractors, or multiple contractors, file
an election to be a party to the hearing,
the first entity to file its election after
the notice of hearing is issued is made
a party to the hearing and the other
entities are made participants in the
proceedings under § 405.1010, subject to
§ 405.1010(d)(1) and (3), unless the ALJ
grants leave to an entity to also be a
party to the hearing in accordance with
paragraph (d)(2) of this section.
(2) If CMS or a contractor filed an
election to be a party in accordance with
this section but is precluded from being
made a party under paragraph (d)(1) of
this section, the ALJ may grant leave to
be a party to the hearing if the ALJ
determines that the entity’s
participation as a party is necessary for
a full examination of the matters at
issue.
(e) Invalid election. (1) An ALJ or
attorney adjudicator may determine that
a CMS or contractor election is invalid
under this section if the request for
hearing was filed by an unrepresented
beneficiary, the election was not timely,
the election was not sent to the correct
parties, or CMS or a contractor had
already filed an election to be a party to
the hearing and the ALJ did not
determine that the entity’s participation
as a party is necessary for a full
examination of the matters at issue.
(2) If an election is determined to be
invalid, a written notice must be sent to
the entity that submitted the election
and the parties who were sent the notice
of hearing.
(i) If the election was submitted after
the hearing occurred, the written notice
of invalid election must be sent no later
than the date the decision, dismissal, or
remand notice is mailed.
(ii) If the election was submitted
before the hearing occurs, the written
notice of invalid election must be sent
prior to the hearing. If the notice would
be sent fewer than 5 calendar days
before the hearing is scheduled to occur,
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oral notice must be provided to the
entity that submitted the election, and
the written notice to the entity and the
parties who were sent the notice of
hearing must be sent as soon as possible
after the oral notice is provided.
■ 28. Section 405.1014 is revised to read
as follows:
§ 405.1014 Request for an ALJ hearing or
a review of a QIC dismissal.
(a) Content of the request. (1) The
request for an ALJ hearing or a review
of a QIC dismissal must be made in
writing. The request must include all of
the following—
(i) The name, address, and Medicare
health insurance claim number of the
beneficiary whose claim is being
appealed, and the beneficiary’s
telephone number if the beneficiary is
the appealing party and not represented.
(ii) The name, address, and telephone
number, of the appellant, when the
appellant is not the beneficiary.
(iii) The name, address, and telephone
number, of the designated
representative, if any.
(iv) The Medicare appeal number or
document control number, if any,
assigned to the QIC reconsideration or
dismissal notice being appealed.
(v) The dates of service of the claim(s)
being appealed, if applicable.
(vi) The reasons the appellant
disagrees with the QIC’s reconsideration
or other determination being appealed.
(vii) A statement of whether the filing
party is aware that it or the claim is the
subject of an investigation or proceeding
by the HHS Office of Inspector General
or other law enforcement agencies.
(viii) For requests filed by providers,
suppliers, Medicaid State agencies,
applicable plans, or a beneficiary who is
represented by a provider, supplier or
Medicaid State agency, the amount in
controversy applicable to the disputed
claim determined in accordance with
§ 405.1006, unless the matter involves a
provider or supplier termination of
Medicare-covered items or services that
is disputed by a beneficiary, and the
beneficiary did not elect to continue
receiving the items or services.
(2) The appellant must submit a
statement of any additional evidence to
be submitted and the date it will be
submitted.
(3) Special rule for appealing
statistical sample and/or extrapolation.
If the appellant disagrees with how a
statistical sample and/or extrapolation
was conducted, the appellant must—
(i) Include the information in
paragraphs (a)(1) and (2) of this section
for each sample claim that the appellant
wishes to appeal;
(ii) File the request for hearing for all
sampled claims that the appellant
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wishes to appeal within 60 calendar
days of the date the party receives the
last reconsideration for the sample
claims, if they were not all addressed in
a single reconsideration; and
(iii) Assert the reasons the appellant
disagrees with how the statistical
sample and/or extrapolation was
conducted in the request for hearing.
(b) Complete request required. (1) A
request must contain the information in
paragraph (a)(1) of this section to the
extent the information is applicable, to
be considered complete. If a request is
not complete, the appellant will be
provided with an opportunity to
complete the request, and if an
adjudication time frame applies, it does
not begin until the request is complete.
If the appellant fails to provide the
information necessary to complete the
request within the time frame provided,
the appellant’s request for hearing or
review will be dismissed.
(2) If supporting materials submitted
with a request clearly provide
information required for a complete
request, the materials will be considered
in determining whether the request is
complete.
(c) When and where to file. The
request for an ALJ hearing or request for
review of a QIC dismissal must be
filed—
(1) Within 60 calendar days from the
date the party receives notice of the
QIC’s reconsideration or dismissal,
except as provided in paragraph
(a)(3)(ii) of this section for appeals of
extrapolations;
(2) With the office specified in the
QIC’s reconsideration or dismissal. If
the request for hearing is timely filed
with an office other than the office
specified in the QIC’s reconsideration,
any applicable time frame specified in
§ 405.1016 for deciding the appeal
begins on the date the office specified in
the QIC’s reconsideration or dismissal
receives the request for hearing. If the
request for hearing is filed with an
office, other than the entity office
specified in the QIC’s reconsideration or
dismissal, OMHA must notify the
appellant of the date the request was
received in the correct office and the
commencement of any applicable
adjudication time frame.
(d) Copy requirement. (1) The
appellant must send a copy of the
request for hearing or request for review
of a QIC dismissal to the other parties
who were sent a copy of the QIC’s
reconsideration or dismissal. If
additional materials submitted with the
request are necessary to provide the
information required for a complete
request in accordance with paragraph
(b) of this section, copies of the
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materials must be sent to the parties as
well (subject to authorities that apply to
disclosing the personal information of
other parties). If additional evidence is
submitted with the request for hearing,
the appellant may send a copy of the
evidence, or briefly describe the
evidence pertinent to the party and offer
to provide copies of the evidence to the
party at the party’s request (subject to
authorities that apply to disclosing the
evidence).
(2) Evidence that a copy of the request
for hearing or request for review of a
QIC dismissal, or a copy of submitted
evidence or a summary thereof, was sent
in accordance with paragraph (d)(1) of
this section includes—
(i) Certification on the standard form
for requesting an ALJ hearing or
requesting a review of a QIC dismissal
that a copy of the request is being sent
to the other parties;
(ii) An indication, such as a copy or
‘‘cc’’ line, on a request for hearing or
request for review of a QIC dismissal
that a copy of the request and any
applicable attachments or enclosures are
being sent to the other parties, including
the name and address of the recipient;
(iii) An affidavit or certificate of
service that identifies the name and
address of the recipient, and what was
sent to the recipient; or
(iv) A mailing or shipping receipt that
identifies the name and address of the
recipient, and what was sent to the
recipient.
(3) If the appellant fails to send a copy
of the request for hearing or request for
review of a QIC dismissal, any
additional materials, or a copy of
submitted evidence or a summary
thereof, as described in paragraph (d)(1)
of this section, the appellant will be
provided with an additional
opportunity to send the request,
materials, and/or evidence or summary
thereof, and if an adjudication time
frame applies, it begins upon receipt of
evidence that the request, materials,
and/or evidence or summary thereof
were sent. If the appellant again fails to
provide evidence that the request,
materials, and/or evidence or summary
thereof were sent within the additional
time frame provided to send the request,
materials, and/or evidence or summary
thereof, the appellant’s request for
hearing or request for review of a QIC
dismissal will be dismissed.
(e) Extension of time to request a
hearing or review. (1) If the request for
hearing or review of a QIC dismissal is
not filed within 60 calendar days of
receipt of the QIC’s reconsideration or
dismissal, an appellant may request an
extension for good cause (See
§ 405.942(b)(2) and (3)).
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(2) Any request for an extension of
time must be in writing, give the reasons
why the request for a hearing or review
was not filed within the stated time
period, and must be filed with the
request for hearing or request for review
of a QIC dismissal with the office
specified in the notice of
reconsideration or dismissal.
(3) An ALJ or attorney adjudicator
may find there is good cause for missing
the deadline to file a request for an ALJ
hearing or request for review of a QIC
dismissal, or there is no good cause for
missing the deadline to file a request for
a review of a QIC dismissal, but only an
ALJ may find there is no good cause for
missing the deadline to file a request for
an ALJ hearing. If good cause is found
for missing the deadline, the time
period for filing the request for hearing
or request for review of a QIC dismissal
will be extended. To determine whether
good cause for late filing exists, the ALJ
or attorney adjudicator uses the
standards set forth in § 405.942(b)(2)
and (3).
(4) If a request for hearing is not
timely filed, any applicable adjudication
period in § 405.1016 begins the date the
ALJ or attorney adjudicator grants the
request to extend the filing deadline.
(5) A determination granting a request
to extend the filing deadline is not
subject to further review.
■ 29. Section 405.1016 is revised to read
as follows:
§ 405.1016 Time frames for deciding an
appeal of a QIC reconsideration or
escalated request for a QIC reconsideration.
(a) Adjudication period for appeals of
QIC reconsiderations. When a request
for an ALJ hearing is filed after a QIC
has issued a reconsideration, an ALJ or
attorney adjudicator issues a decision,
dismissal order, or remand to the QIC,
as appropriate, no later than the end of
the 90 calendar day period beginning on
the date the request for hearing is
received by the office specified in the
QIC’s notice of reconsideration, unless
the 90 calendar day period has been
extended as provided in this subpart.
(b) When the adjudication period
begins. (1) Unless otherwise specified in
this subpart, the adjudication period
specified in paragraph (a) of this section
begins on the date that a timely filed
request for hearing is received by the
office specified in the QIC’s
reconsideration, or, if it is not timely
filed, the date that the ALJ or attorney
adjudicator grants any extension to the
filing deadline.
(2) If the Council remands a case and
the case was subject to an adjudication
time frame under paragraph (a) or (c) of
this section, the remanded appeal will
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be subject to the adjudication time
frame of paragraph (a) of this section
beginning on the date that OMHA
receives the Council remand.
(c) Adjudication period for escalated
requests for QIC reconsiderations. When
an appeal is escalated to OMHA because
the QIC has not issued a reconsideration
determination within the period
specified in § 405.970, an ALJ or
attorney adjudicator issues a decision,
dismissal order, or remand to the QIC,
as appropriate, no later than the end of
the 180 calendar day period beginning
on the date that the request for
escalation is received by OMHA in
accordance with § 405.970, unless the
180 calendar day period is extended as
provided in this subpart.
(d) Waivers and extensions of
adjudication period. (1) At any time
during the adjudication process, the
appellant may waive the adjudication
period specified in paragraphs (a) and
(c) of this section. The waiver may be
for a specific period of time agreed upon
by the ALJ or attorney adjudicator and
the appellant.
(2) The adjudication periods specified
in paragraphs (a) and (c) of this section
are extended as otherwise specified in
this subpart, and for the following
events—
(i) The duration of a stay of action on
adjudicating the claims or matters at
issue ordered by a court or tribunal of
competent jurisdiction; or
(ii) The duration of a stay of
proceedings granted by an ALJ or
attorney adjudicator on a motion by an
appellant, provided no other party also
filed a request for hearing on the same
claim at issue.
(e) Effect of exceeding adjudication
period. If an ALJ or attorney adjudicator
fails to issue a decision, dismissal order,
or remand to the QIC within an
adjudication period specified in this
section, subject to paragraphs (b) and (d)
of this section, the party that filed the
request for hearing may escalate the
appeal in accordance with paragraph (f)
of this section. If the party that filed the
request for hearing does not elect to
escalate the appeal, the appeal remains
pending with OMHA for a decision,
dismissal order, or remand.
(f) Requesting escalation. (1) When
and how to request escalation. An
appellant who files a timely request for
hearing before an ALJ and whose appeal
continues to be pending with OMHA at
the end of the applicable adjudication
period under paragraph (a) or (c) of this
section, subject to paragraphs (b) and (d)
of this section, may exercise the option
of escalating the appeal to the Council
by filing a written request with OMHA
to escalate the appeal to the Council and
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sending a copy of the request to escalate
to the other parties who were sent a
copy of the QIC reconsideration.
(2) Escalation. If the request for
escalation meets the requirements of
paragraph (f)(1) of this section and an
ALJ or attorney adjudicator is not able
to issue a decision, dismissal order, or
remand order within the later of 5
calendar days of receiving the request
for escalation, or 5 calendar days from
the end of the applicable adjudication
period set forth in paragraph (a) or (c)
of this section, subject to paragraphs (b)
and (d) of this section, OMHA will take
the following actions—
(i) Send a notice to the appellant
stating that an ALJ or attorney
adjudicator is not able to issue a
decision, dismissal order, or remand
order within the adjudication period set
forth in paragraph (a) or (c) of this
section, the QIC reconsideration will be
the decision that is subject to Council
review consistent with § 405.1102(a),
and the appeal will be escalated to the
Council for a review in accordance with
§ 405.1108; and
(ii) Forward the case file to the
Council.
(3) Invalid escalation request. If an
ALJ or attorney adjudicator determines
the request for escalation does not meet
the requirements of paragraph (f)(1) of
this section, OMHA will send a notice
to the appellant explaining why the
request is invalid within 5 calendar
days of receiving the request for
escalation.
■ 30. Section 405.1018 is revised to read
as follows:
§ 405.1018
Submitting evidence.
(a) When evidence may be submitted.
Except as provided in this section,
parties must submit all written or other
evidence they wish to have considered
with the request for hearing, by the date
specified in the request for hearing in
accordance with § 405.1014(a)(2), or if a
hearing is scheduled, within 10
calendar days of receiving the notice of
hearing.
(b) Effect on adjudication period. If a
party submits written or other evidence
later than 10 calendar days after
receiving the notice of hearing, any
applicable adjudication period specified
in § 405.1016 is extended by the number
of calendar days in the period between
10 calendar days after receipt of the
notice of hearing and the day the
evidence is received.
(c) New evidence. (1) Any evidence
submitted by a provider, supplier, or
beneficiary represented by a provider or
supplier that is not submitted prior to
the issuance of the QIC’s
reconsideration determination must be
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accompanied by a statement explaining
why the evidence was not previously
submitted to the QIC, or a prior
decision-maker (see § 405.1028).
(2) If a statement explaining why the
evidence was not previously submitted
to the QIC or a prior decision-maker is
not included with the evidence, the
evidence will not be considered.
(d) When this section does not apply.
The requirements of this section do not
apply to oral testimony given at a
hearing, or to evidence submitted by an
unrepresented beneficiary.
■ 31. Section 405.1020 is amended by—
■ a. Revising paragraphs (b), (c), (d), and
(e)(3) and (4).
■ b. Adding paragraphs (g)(3)(vii) and
(viii).
■ c. Revising paragraphs (h), (i)
paragraph heading, and (i)(1), (2), (4),
and (5).
■ d. Adding paragraph (j).
The revisions and additions read as
follows:
§ 405.1020 Time and place for a hearing
before an ALJ.
*
*
*
*
*
(b) Determining how appearances are
made. (1) Appearances by
unrepresented beneficiaries. The ALJ
will direct that the appearance of an
unrepresented beneficiary who filed a
request for hearing be conducted by
video-teleconferencing (VTC) if the ALJ
finds that VTC technology is available to
conduct the appearance, unless the ALJ
find good cause for an in-person
appearance.
(i) The ALJ may also offer to conduct
a hearing by telephone if the request for
hearing or administrative record
suggests that a telephone hearing may
be more convenient for the
unrepresented beneficiary.
(ii) The ALJ, with the concurrence of
the Chief ALJ or designee, may find
good cause that an in-person hearing
should be conducted if—
(A) VTC or telephone technology is
not available; or
(B) Special or extraordinary
circumstances exist.
(2) Appearances by individuals other
than unrepresented beneficiaries. The
ALJ will direct that the appearance of an
individual, other than an unrepresented
beneficiary who filed a request for
hearing, be conducted by telephone,
unless the ALJ finds good cause for an
appearance by other means.
(i) The ALJ may find good cause for
an appearance by VTC if he or she
determines that VTC is necessary to
examine the facts or issues involved in
the appeal.
(ii) The ALJ, with the concurrence of
the Chief ALJ or designee, also may find
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good cause that an in-person hearing
should be conducted if—
(A) VTC and telephone technology are
not available; or
(B) Special or extraordinary
circumstances exist.
(c) Notice of hearing. (1) A notice of
hearing is sent to all parties that filed an
appeal or participated in the
reconsideration, any party who was
found liable for the services at issue
subsequent to the initial determination
or may be found liable based on a
review of the record, the QIC that issued
the reconsideration, and CMS or a
contractor that the ALJ believes would
be beneficial to the hearing, advising
them of the proposed time and place of
the hearing.
(2) The notice of hearing will require
all parties to the ALJ hearing to reply to
the notice by:
(i) Acknowledging whether they plan
to attend the hearing at the time and
place proposed in the notice of hearing,
or whether they object to the proposed
time and/or place of the hearing;
(ii) If the party or representative is an
entity or organization, specifying who
from the entity or organization plans to
attend the hearing, if anyone, and in
what capacity, in addition to the
individual who filed the request for
hearing; and
(iii) Listing the witnesses who will be
providing testimony at the hearing.
(3) The notice of hearing will require
CMS or a contractor that wishes to
attend the hearing as a participant to
reply to the notice by:
(i) Acknowledging whether it plans to
attend the hearing at the time and place
proposed in the notice of hearing; and
(ii) Specifying who from the entity
plans to attend the hearing.
(d) A party’s right to waive a hearing.
A party may also waive the right to a
hearing and request a decision based on
the written evidence in the record in
accordance with § 405.1038(b). As
provided in § 405.1000, an ALJ may
require the parties to attend a hearing if
it is necessary to decide the case. If an
ALJ determines that it is necessary to
obtain testimony from a non-party, he or
she may still hold a hearing to obtain
that testimony, even if all of the parties
have waived the right to appear. In
those cases, the ALJ will give the parties
the opportunity to appear when the
testimony is given but may hold the
hearing even if none of the parties
decide to appear.
(e) * * *
(3) The request must be in writing,
except that a party may orally request
that a hearing be rescheduled in an
emergency circumstance the day prior
to or day of the hearing. The ALJ must
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document all oral requests for a
rescheduled hearing in writing and
maintain the documentation in the
administrative record.
(4) The ALJ may change the time or
place of the hearing if the party has
good cause.
*
*
*
*
*
(g) * * *
(3) * * *
(vii) The party or representative has a
prior commitment that cannot be
changed without significant expense.
(viii) The party or representative
asserts that he or she did not receive the
notice of hearing and is unable to
appear at the scheduled time and place.
(h) Effect of rescheduling hearing. If a
hearing is postponed at the request of
the appellant for any of the above
reasons, the time between the originally
scheduled hearing date and the new
hearing date is not counted toward the
adjudication period specified in
§ 405.1016.
(i) A party’s request for an in-person
or VTC hearing. (1) If an unrepresented
beneficiary who filed the request for
hearing objects to a VTC hearing or to
the ALJ’s offer to conduct a hearing by
telephone, or if a party other than an
unrepresented beneficiary who filed the
request for hearing objects to a
telephone or VTC hearing, the party
must notify the ALJ at the earliest
possible opportunity before the time set
for the hearing and request a VTC or an
in-person hearing.
(2) The party must state the reason for
the objection and state the time and/or
place he or she wants an in-person or
VTC hearing to be held.
*
*
*
*
*
(4) When a party’s request for an inperson or VTC hearing as specified
under paragraph (i)(1) of this section is
granted and an adjudication time frame
applies in accordance with § 405.1016,
the ALJ issues a decision, dismissal, or
remand to the QIC within the
adjudication time frame specified in
§ 405.1016 (including any applicable
extensions provided in this subpart)
unless the party requesting the hearing
agrees to waive such adjudication time
frame in writing.
(5) The ALJ may grant the request,
with the concurrence of the Chief ALJ
or designee, upon a finding of good
cause and will reschedule the hearing
for a time and place when the party may
appear in person or by VTC before the
ALJ.
(j) Amended notice of hearing. If the
ALJ changes or will change the time
and/or place of the hearing, an amended
notice of hearing must be sent to all of
the parties who were sent a copy of the
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notice of hearing and CMS or its
contractors that elected to be a
participant or party to the hearing in
accordance with § 405.1022(a).
■ 32. Section 405.1022 is revised to read
as follows:
§ 405.1022
ALJ.
Notice of a hearing before an
(a) Issuing the notice. After the ALJ
sets the time and place of the hearing,
notice of the hearing will be mailed or
otherwise transmitted in accordance
with OMHA procedures to the parties
and other potential participants, as
provided in § 405.1020(c) at their last
known address, or given by personal
service, except to a party or potential
participant who indicates in writing that
it does not wish to receive this notice.
The notice is mailed, transmitted, or
served at least 20 calendar days before
the hearing unless the recipient agrees
in writing to the notice being mailed,
transmitted, or served fewer than 20
calendar days before the hearing.
(b) Notice information. (1) The notice
of hearing contains—
(i) A statement that the issues before
the ALJ include all of the issues brought
out in the initial determination,
redetermination, or reconsideration that
were not decided entirely in a party’s
favor, for the claims specified in the
request for hearing; and
(ii) A statement of any specific new
issues the ALJ will consider in
accordance with § 405.1032.
(2) The notice will inform the parties
that they may designate a person to
represent them during the proceedings.
(3) The notice must include an
explanation of the procedures for
requesting a change in the time or place
of the hearing, a reminder that the ALJ
may dismiss the hearing request if the
appellant fails to appear at the
scheduled hearing without good cause,
and other information about the
scheduling and conduct of the hearing.
(4) The appellant will also be told if
his or her appearance or that of any
other party or witness is scheduled by
VTC, telephone, or in person. If the ALJ
has scheduled the appellant or other
party to appear at the hearing by VTC,
the notice of hearing will advise that the
scheduled place for the hearing is a VTC
site and explain what it means to appear
at the hearing by VTC.
(5) The notice advises the appellant or
other parties that if they object to
appearing by VTC or telephone, and
wish instead to have their hearing at a
time and place where they may appear
in person before the ALJ, they must
follow the procedures set forth at
§ 405.1020(i) for notifying the ALJ of
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their objections and for requesting an inperson hearing.
(c) Acknowledging the notice of
hearing. (1) If the appellant, any other
party to the reconsideration to whom
the notice of hearing was sent, or their
representative does not acknowledge
receipt of the notice of hearing, OMHA
attempts to contact the party for an
explanation.
(2) If the party states that he or she did
not receive the notice of hearing, a copy
of the notice is sent to him or her by
certified mail or other means requested
by the party and in accordance with
OMHA procedures.
(3) The party may request that the ALJ
reschedule the hearing in accordance
with § 405.1020(e).
■ 33. Section 405.1024 is amended by
revising paragraphs (b) and (c) to read
as follows:
§ 405.1024
Objections to the issues.
*
*
*
*
*
(b) The party must state the reasons
for his or her objections and send a copy
of the objections to all other parties who
were sent a copy of the notice of
hearing, and CMS or a contractor that
elected to be a party to the hearing.
(c) The ALJ makes a decision on the
objections either in writing, at a
prehearing conference, or at the hearing.
■ 34. Section 405.1026 is revised to read
as follows:
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§ 405.1026 Disqualification of the ALJ or
attorney adjudicator.
(a) An ALJ or attorney adjudicator
cannot adjudicate an appeal if he or she
is prejudiced or partial to any party or
has any interest in the matter pending
for decision.
(b) If a party objects to the ALJ or
attorney adjudicator assigned to
adjudicate the appeal, the party must
notify the ALJ within 10 calendar days
of the date of the notice of hearing if a
hearing is scheduled, or the ALJ or
attorney adjudicator at any time before
a decision, dismissal order, or remand
order is issued if no hearing is
scheduled. The ALJ or attorney
adjudicator considers the party’s
objections and decides whether to
proceed with the appeal or withdraw.
(c) If the ALJ or attorney adjudicator
withdraws, another ALJ or attorney
adjudicator will be assigned to
adjudicate the appeal. If the ALJ or
attorney adjudicator does not withdraw,
the party may, after the ALJ or attorney
adjudicator has issued an action in the
case, present his or her objections to the
Council in accordance with § 405.1100
through § 405.1130. The Council will
then consider whether the decision or
dismissal should be revised or if
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applicable, a new hearing held before
another ALJ. If the case is escalated to
the Council after a hearing is held but
before the ALJ issues a decision, the
Council considers the reasons the party
objected to the ALJ during its review of
the case and, if the Council deems it
necessary, may remand the case to
another ALJ for a hearing and decision.
(d) If the party objects to the ALJ or
attorney adjudicator and the ALJ or
attorney adjudicator subsequently
withdraws from the appeal, any
adjudication time frame that applies to
the appeal in accordance with
§ 405.1016 is extended by 14 calendar
days.
■ 35. Section 405.1028 is revised to read
as follows:
§ 405.1028 Review of evidence submitted
by parties.
(a) New evidence—(1) Examination of
any new evidence. After a hearing is
requested but before a hearing is held by
an ALJ or a decision is issued if no
hearing is held, the ALJ or attorney
adjudicator will examine any new
evidence submitted in accordance with
§ 405.1018, by a provider, supplier, or
beneficiary represented by a provider or
supplier to determine whether the
provider, supplier, or beneficiary
represented by a provider or supplier
had good cause for submitting the
evidence for the first time at the OMHA
level.
(2) Determining if good cause exists.
An ALJ or attorney adjudicator finds
good cause when—
(i) The new evidence is, in the
opinion of the ALJ or attorney
adjudicator, material to an issue
addressed in the QIC’s reconsideration
and that issue was not identified as a
material issue prior to the QIC’s
reconsideration;
(ii) The new evidence is, in the
opinion of the ALJ, material to a new
issue identified in accordance with
§ 405.1032(b)(1);
(iii) The party was unable to obtain
the evidence before the QIC issued its
reconsideration and submits evidence
that, in the opinion of the ALJ or
attorney adjudicator, demonstrates the
party made reasonable attempts to
obtain the evidence before the QIC
issued its reconsideration;
(iv) The party asserts that the
evidence was submitted to the QIC or
another contractor and submits
evidence that, in the opinion of the ALJ
or attorney adjudicator, demonstrates
the new evidence was submitted to the
QIC or another contractor before the QIC
issued the reconsideration; or
(v) In circumstances not addressed in
paragraphs (a)(2)(i) through (iv) of this
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section, the ALJ or attorney adjudicator
determines that the party has
demonstrated that it could not have
obtained the evidence before the QIC
issued its reconsideration.
(3) If good cause does not exist. If the
ALJ or attorney adjudicator determines
that there was not good cause for
submitting the evidence for the first
time at the OMHA level, the ALJ or
attorney adjudicator must exclude the
evidence from the proceeding and may
not consider it in reaching a decision.
(4) Notification to parties. If a hearing
is conducted, as soon as possible, but no
later than the start of the hearing, the
ALJ must notify all parties and
participants who responded to the
notice of hearing whether the evidence
will be considered or is excluded from
consideration.
(b) Duplicative evidence. The ALJ or
attorney adjudicator may exclude from
consideration any evidence submitted
by a party at the OMHA level that is
duplicative of evidence already in the
record forwarded to OMHA.
■ 36. Section 405.1030 is revised to read
as follows:
§ 405.1030
ALJ hearing procedures.
(a) General rule. A hearing is open to
the parties and to other persons the ALJ
considers necessary and proper.
(b) At the hearing. (1) At the hearing,
the ALJ fully examines the issues,
questions the parties and other
witnesses, and may accept evidence that
is material to the issues consistent with
§§ 405.1018 and 405.1028.
(2) The ALJ may limit testimony and/
or argument at the hearing that are not
relevant to an issue before the ALJ, or
that address an issue before the ALJ for
which the ALJ determines he or she has
sufficient information or on which the
ALJ has already ruled. The ALJ may, but
is not required to, provide the party or
representative with an opportunity to
submit additional written statements
and affidavits on the matter, in lieu of
testimony and/or argument at the
hearing. The written statements and
affidavits must be submitted within the
time frame designated by the ALJ.
(3) If the ALJ determines that a party
or party’s representative is
uncooperative, disruptive to the
hearing, or abusive during the course of
the hearing, the ALJ may excuse the
party or representative from the hearing
and continue with the hearing to
provide the other parties and
participants with an opportunity to offer
testimony and/or argument. If a party or
representative was excused from the
hearing, the ALJ will provide the party
or representative with an opportunity to
submit written statements and affidavits
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in lieu of testimony and/or argument at
the hearing, and the party or
representative may request a recording
of the hearing in accordance with
§ 405.1042 and respond in writing to
any statements made by other parties or
participants and/or testimony of the
witnesses at the hearing. The written
statements and affidavits must be
submitted within the time frame
designated by the ALJ.
(c) Missing evidence. The ALJ may
also stop the hearing temporarily and
continue it at a later date if he or she
believes that there is material evidence
missing at the hearing. If the missing
evidence is in the possession of the
appellant, and the appellant is a
provider, supplier, or a beneficiary
represented by a provider or supplier,
the ALJ must determine if the appellant
had good cause in accordance with
§ 405.1028 for not producing the
evidence earlier.
(d) Effect of New evidence on
adjudication period. If an appellant,
other than an unrepresented beneficiary,
submits evidence pursuant to paragraph
(b) or (c) of this section, and an
adjudication period applies to the
appeal, the adjudication period
specified in § 405.1016 is extended in
accordance with § 405.1018(b).
(e) Continued hearing. (1) A hearing
may be continued to a later date. Notice
of the continued hearing must be sent in
accordance with § 405.1022, except that
a waiver of notice of the hearing may be
made in writing or on the record, and
the notice is sent to the parties and
participants who attended the hearing,
and any additional parties or potential
parties or participants the ALJ
determines are appropriate.
(2) If the appellant requests the
continuance and an adjudication period
applies to the appeal in accordance with
§ 405.1016, the adjudication period is
extended by the period between the
initial hearing date and the continued
hearing date.
(f) Supplemental hearing. (1) The ALJ
may conduct a supplemental hearing at
any time before he or she mails a notice
of the decision in order to receive new
and material evidence, obtain additional
testimony, or address a procedural
matter. The ALJ determines whether a
supplemental hearing is necessary and
if one is held, the scope of the hearing,
including when evidence is presented
and what issues are discussed. Notice of
the supplemental hearing must be sent
in accordance with § 405.1022, except
that the notice is sent to the parties and
participants who attended the hearing,
and any additional parties or potential
parties or participants the ALJ
determines are appropriate.
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(2) If the appellant requests the
supplemental hearing and an
adjudication period applies to the
appeal in accordance with § 405.1016,
the adjudication period is extended by
the period between the initial hearing
date and the supplemental hearing date.
■ 37. Section 405.1032 is revised to read
as follows:
§ 405.1032 Issues before an ALJ or
attorney adjudicator.
(a) General rule. The issues before the
ALJ or attorney adjudicator include all
the issues for the claims or appealed
matter specified in the request for
hearing that were brought out in the
initial determination, redetermination,
or reconsideration that were not decided
entirely in a party’s favor. (For purposes
of this provision, the term ‘‘party’’ does
not include a representative of CMS or
one of its contractors that may be
participating in the hearing.)
(b) New issues—(1) When a new issue
may be considered. A new issue may
include issues resulting from the
participation of CMS or its contractor at
the OMHA level of adjudication and
from any evidence and position papers
submitted by CMS or its contractor for
the first time to the ALJ. The ALJ or any
party may raise a new issue relating to
a claim or appealed matter specified in
the request for hearing; however, the
ALJ may only consider a new issue,
including a favorable portion of a
determination on a claim or appealed
matter specified in the request for
hearing, if its resolution could have a
material impact on the claim or
appealed matter and—
(i) There is new and material evidence
that was not available or known at the
time of the determination and that may
result in a different conclusion; or
(ii) The evidence that was considered
in making the determination clearly
shows on its face that an obvious error
was made at the time of the
determination.
(2) Notice of the new issue. The ALJ
may consider a new issue at the hearing
if he or she notifies the parties that were
or will be sent the notice of hearing
about the new issue before the start of
the hearing.
(3) Opportunity to submit evidence. If
notice of the new issue is sent after the
notice of hearing, the parties will have
at least 10 calendar days after receiving
notice of the new issue to submit
evidence regarding the issue, and
without affecting any applicable
adjudication period. If a hearing is
conducted before the time to submit
evidence regarding the issue expires, the
record will remain open until the
opportunity to submit evidence expires.
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(c) Adding claims to a pending
appeal. (1) Claims that were not
specified in a request for hearing may
only be added to a pending appeal if the
claims were adjudicated in the same
reconsideration that is appealed, and
the period to request an ALJ hearing for
that reconsideration has not expired, or
an ALJ or attorney adjudicator extends
the time to request an ALJ hearing on
those claims in accordance with
§ 405.1014(e).
(2) Before a claim may be added to a
pending appeal, the appellant must
submit evidence that demonstrates the
information that constitutes a complete
request for hearing in accordance with
§ 405.1014(b) and other materials
related to the claim that the appellant
seeks to add to the pending appeal were
sent to the other parties to the claim in
accordance with § 405.1014(d).
(d) Appeals involving statistical
sampling and extrapolations. (1)
Generally. If the appellant does not
assert the reasons the appellant
disagrees with how a statistical sample
and/or extrapolation was conducted in
the request for hearing, in accordance
with § 405.1014(a)(3)(iii), issues related
to how the statistical sample and
extrapolation were conducted shall not
be considered or decided.
(2) Consideration of sample claims. If
a party asserts a disagreement with how
a statistical sample and/or extrapolation
was conducted in the request for
hearing, in accordance with
§ 405.1014(a)(3)(iii), paragraphs (a)
through (c) of this section apply to the
adjudication of the sample claims but,
in deciding issues related to how a
statistical sample and/or extrapolation
was conducted the ALJ or attorney
adjudicator must base his or her
decision on a review of the entire
sample to the extent appropriate to
decide the issue.
■ 38. Section 405.1034 is revised to read
as follows:
§ 405.1034
the QIC.
Requesting information from
(a) If an ALJ or attorney adjudicator
believes that the written record is
missing information that is essential to
resolving the issues on appeal and that
information can be provided only by
CMS or its contractors, the information
may be requested from the QIC that
conducted the reconsideration or its
successor.
(1) Official copies of redeterminations
and reconsiderations that were
conducted on the appealed claims can
be provided only by CMS or its
contractors.
(2) ‘‘Can be provided only by CMS or
its contractors’’ means the information
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is not publicly available, is not in the
possession of, and cannot be requested
and obtained by one of the parties.
Information that is publicly available is
information that is available to the
general public via the Internet or in a
printed publication. Information that is
publicly available includes, but is not
limited to, information available on a
CMS or contractor Web site or
information in an official CMS or DHHS
publication (including, but not limited
to, provisions of NCDs or LCDs,
procedure code or modifier
descriptions, fee schedule data, and
contractor operating manual
instructions).
(b) The ALJ or attorney adjudicator
retains jurisdiction of the case, and the
case remains pending at OMHA.
(c) The QIC has 15 calendar days after
receiving the request for information to
furnish the information or otherwise
respond to the information request
directly or through CMS or another
contractor.
(d) If an adjudication period applies
to the appeal in accordance with
§ 405.1016, the adjudication period is
extended by the period between the date
of the request for information and the
date the QIC responds to the request or
20 calendar days after the date of the
request, whichever occurs first.
§ 405.1036
[Amended]
39. Section 405.1036 is amended by—
a. Amending paragraph (b)(1) by
removing the phrase ‘‘send the ALJ’’ and
adding ‘‘submit to OMHA’’ in its place.
■ b. Removing paragraph (d).
■ c. Redesignating paragraph (g) as new
paragraph (d).
■ d. Amending paragraphs (f)(5)(i), (ii),
(iii), (iv), (v), and (vi) by removing the
term ‘‘MAC’’ each time it appears and
adding ‘‘Council’’ in its place.
■ e. Amending paragraphs (f)(5)(i) and
(ii) by removing the term ‘‘MAC’s’’ and
adding ‘‘Council’s’’ in its place.
■ f. Amending paragraph (f)(5)(i) by
removing the phrase ‘‘specified in
§ 405.1102, § 405.1104, or § 405.1110’’
and adding ‘‘specified in § 405.1016(e)
and (f), § 405.1102, or § 405.1110’’ in its
place.
■ g. Amending paragraph (f)(5)(ii) by
removing the phrase ‘‘discovery ruling’’
each time it appears and adding
‘‘subpoena ruling’’ in its place.
■ 40. Section 405.1037 is amended by—
■ a. Revising paragraph (a)(1).
■ b. Amending paragraph (e)(1) by
removing the phrase ‘‘specified in
§ 405.1100, § 405.1102, § 405.1104, or
§ 405.1110’’ and adding ‘‘specified in
§ 405.1016(e) and (f), § 405.1100,
§ 405.1102, or § 405.1110’’ in its place.
■ c. Amending paragraphs (e)(1), (e)(2)
introductory text, (e)(2)(i), (ii), (iii), (iv),
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■
■
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and (v) by removing the term ‘‘MAC’’
each time it appears and adding
‘‘Council’’ in its place.
■ d. Amending paragraphs (e)(1) and
(e)(2)(i) by removing the term ‘‘MAC’s’’
and adding ‘‘Council’s’’ in its place.
■ e. Revising paragraph (f).
The revisions read as follows:
§ 405.1037
Discovery.
(a) * * *
(1) Discovery is permissible only
when CMS or its contractor elects to be
a party to an ALJ hearing, in accordance
with § 405.1012.
*
*
*
*
*
(f) Adjudication period. If an
adjudication period applies to the
appeal in accordance with § 405.1016,
and a party requests discovery from
another party to the hearing, the
adjudication period is extended for the
duration of discovery, from the date a
discovery request is granted until the
date specified for ending discovery.
■ 41. Section 405.1038 is revised to read
as follows:
§ 405.1038 Deciding a case without a
hearing before an ALJ.
(a) Decision fully favorable. If the
evidence in the administrative record
supports a finding fully in favor of the
appellant(s) on every issue and no other
party to the appeal is liable for claims
at issue, an ALJ or attorney adjudicator
may issue a decision without giving the
parties prior notice and without an ALJ
conducting a hearing, unless CMS or a
contractor has elected to be a party to
the hearing in accordance with
§ 405.1012. The notice of the decision
informs the parties that they have the
right to a hearing and a right to examine
the evidence on which the decision is
based.
(b) Parties do not wish to appear. (1)
An ALJ or attorney adjudicator may
decide a case on the record and without
an ALJ conducting a hearing if—
(i) All the parties who would be sent
a notice of hearing in accordance with
§ 405.1020(c) indicate in writing that
they do not wish to appear before an
ALJ at a hearing, including a hearing
conducted by telephone or videoteleconferencing, if available; or
(ii) The appellant lives outside the
United States and does not inform
OMHA that he or she wants to appear
at a hearing before an ALJ, and there are
no other parties who would be sent a
notice of hearing in accordance with
§ 405.1020(c) and who wish to appear.
(2) When a hearing is not held, the
decision of the ALJ or attorney
adjudicator must refer to the evidence in
the record on which the decision was
based.
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(c) Stipulated decision. If CMS or one
of its contractors submits a written
statement or makes an oral statement at
a hearing indicating the item or service
should be covered or payment may be
made, an ALJ or attorney adjudicator
may issue a stipulated decision finding
in favor of the appellant or other liable
parties on the basis of the statement,
and without making findings of fact,
conclusions of law, or further
explaining the reasons for the decision.
■ 42. Section 405.1040 is revised to read
as follows:
§ 405.1040 Prehearing and posthearing
conferences.
(a) The ALJ may decide on his or her
own, or at the request of any party to the
hearing, to hold a prehearing or
posthearing conference to facilitate the
hearing or the hearing decision.
(b) The ALJ informs the parties who
will be or were sent a notice of hearing
in accordance with § 405.1020(c), and
CMS or a contractor that has elected to
be a participant in the proceedings or
party to the hearing at the time the
notice of conference is sent, of the time,
place, and purpose of the conference at
least 7 calendar days before the
conference date, unless a party indicates
in writing that it does not wish to
receive a written notice of the
conference.
(c) At the conference—
(1) The ALJ or an OMHA attorney
designated by the ALJ conducts the
conference, but only the ALJ conducting
a conference may consider matters in
addition to those stated in the
conference notice if the parties consent
to consideration of the additional
matters in writing.
(2) An audio recording of the
conference is made.
(d) The ALJ issues an order to all
parties and participants who attended
the conference stating all agreements
and actions resulting from the
conference. If a party does not object
within 10 calendar days of receiving the
order, or any additional time granted by
the ALJ, the agreements and actions
become part of the administrative record
and are binding on all parties.
■ 43. Section 405.1042 is revised to read
as follows:
§ 405.1042
The administrative record.
(a) Creating the record. (1) OMHA
makes a complete record of the evidence
and administrative proceedings on the
appealed matter, including any
prehearing and posthearing conferences,
and hearing proceedings that were
conducted.
(2) The record will include marked as
exhibits, the appealed determinations,
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and documents and other evidence used
in making the appealed determinations
and the ALJ’s or attorney adjudicator’s
decision, including, but not limited to,
claims, medical records, written
statements, certificates, reports,
affidavits, and any other evidence the
ALJ or attorney adjudicator admits. The
record will also include any evidence
excluded or not considered by the ALJ
or attorney adjudicator, including, but
not limited to, new evidence submitted
by a provider or supplier, or beneficiary
represented by a provider or supplier,
for which no good cause was
established, and duplicative evidence
submitted by a party.
(3) A party may request and review a
copy of the record prior to or at the
hearing, or, if a hearing is not held, at
any time before the notice of decision is
issued.
(4) If a request for review is filed or
the case is escalated to the Council, the
complete record, including any
prehearing and posthearing conference
and hearing recordings, is forwarded to
the Council.
(5) A typed transcription of the
hearing is prepared if a party seeks
judicial review of the case in a Federal
district court within the stated time
period and all other jurisdictional
criteria are met, unless, upon the
Secretary’s motion prior to the filing of
an answer, the court remands the case.
(b) Requesting and receiving copies of
the record. (1) While an appeal is
pending at OMHA, a party may request
and receive a copy of all or part of the
record from OMHA, including any
index of the administrative record,
documentary evidence, and a copy of
the audio recording of the oral
proceedings. The party may be asked to
pay the costs of providing these items.
(2) If a party requests a copy of all or
part of the record from OMHA or the
ALJ or attorney adjudicator and an
opportunity to comment on the record,
any adjudication period that applies in
accordance with § 405.1016 is extended
by the time beginning with the receipt
of the request through the expiration of
the time granted for the party’s
response.
(3) If a party requests a copy of all or
part of the record and the record,
including any audio recordings,
contains information pertaining to an
individual that the requesting party is
not entitled to receive, such as
personally identifiable information or
protected health information, such
portions of the record will not be
furnished unless the requesting party
obtains consent from the individual.
■ 44. Section 405.1044 is revised to read
as follows:
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§ 405.1044
Consolidated proceedings.
(a) Consolidated hearing. (1) A
consolidated hearing may be held if one
or more of the issues to be considered
at the hearing are the same issues that
are involved in one or more other
appeals pending before the same ALJ.
(2) It is within the discretion of the
ALJ to grant or deny an appellant’s
request for consolidation. In considering
an appellant’s request, the ALJ may
consider factors such as whether the
claims at issue may be more efficiently
decided if the appeals are consolidated
for hearing. In considering the
appellant’s request for consolidation,
the ALJ must take into account any
adjudication deadlines for each appeal
and may require an appellant to waive
the adjudication deadline associated
with one or more appeals if
consolidation otherwise prevents the
ALJ from deciding all of the appeals at
issue within their respective deadlines.
(3) The ALJ may also propose on his
or her own motion to consolidate two or
more appeals in one hearing for
administrative efficiency, but may not
require an appellant to waive the
adjudication deadline for any of the
consolidated cases.
(4) Notice of a consolidated hearing
must be included in the notice of
hearing issued in accordance with
§§ 405.1020 and 405.1022.
(b) Consolidated or separate decision
and record. (1) If the ALJ decides to
hold a consolidated hearing, he or she
may make either—
(i) A consolidated decision and
record; or
(ii) A separate decision and record on
each appeal.
(2) If a separate decision and record
on each appeal is made, the ALJ is
responsible for making sure that any
evidence that is common to all appeals
and material to the common issue to be
decided, and audio recordings of any
conferences that were conducted and
the consolidated hearing are included in
each individual administrative record,
as applicable.
(3) If a hearing will not be conducted
for multiple appeals that are before the
same ALJ or attorney adjudicator, and
the appeals involve one or more of the
same issues, the ALJ or attorney
adjudicator may make a consolidated
decision and record at the request of the
appellant or on the ALJ’s or attorney
adjudicator’s own motion.
(c) Limitation on consolidated
proceedings. Consolidated proceedings
may only be conducted for appeals filed
by the same appellant, unless multiple
appellants aggregated claims to meet the
amount in controversy requirement in
accordance with § 405.1006 and the
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beneficiaries whose claims are at issue
have all authorized disclosure of their
protected information to the other
parties and any participants.
■ 45. Section 405.1046 is revised to read
as follows:
§ 405.1046 Notice of an ALJ or attorney
adjudicator decision.
(a) Decisions on requests for hearing—
(1) General rule. Unless the ALJ or
attorney adjudicator dismisses or
remands the request for hearing, the ALJ
or attorney adjudicator will issue a
written decision that gives the findings
of fact, conclusions of law, and the
reasons for the decision. The decision
must be based on evidence offered at the
hearing or otherwise admitted into the
record, and shall include independent
findings and conclusions. OMHA mails
or otherwise transmits a copy of the
decision to all the parties at their last
known address and the QIC that issued
the reconsideration or from which the
appeal was escalated. For overpayment
cases involving multiple beneficiaries,
where there is no beneficiary liability,
the ALJ or attorney adjudicator may
choose to send written notice only to
the appellant. In the event a payment
will be made to a provider or supplier
in conjunction with the ALJ’s or
attorney adjudicator’s decision, the
contractor must also issue a revised
electronic or paper remittance advice to
that provider or supplier.
(2) Content of the notice. The decision
must be written in a manner calculated
to be understood by a beneficiary and
must include—
(i) The specific reasons for the
determination, including, to the extent
appropriate, a summary of any clinical
or scientific evidence used in making
the determination;
(ii) For any new evidence that was
submitted for the first time at the
OMHA level and subject to a good cause
determination pursuant to § 405.1028, a
discussion of the new evidence and the
good cause determination that was
made.
(iii) The procedures for obtaining
additional information concerning the
decision; and
(iv) Notification of the right to appeal
the decision to the Council, including
instructions on how to initiate an appeal
under this section.
(3) Limitation on decision. When the
amount of payment for an item or
service is an issue before the ALJ or
attorney adjudicator, the ALJ or attorney
adjudicator may make a finding as to the
amount of payment due. If the ALJ or
attorney adjudicator makes a finding
concerning payment when the amount
of payment was not an issue before the
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ALJ or attorney adjudicator, the
contractor may independently
determine the payment amount. In
either of the aforementioned situations,
an ALJ’s or attorney adjudicator’s
decision is not binding on the contractor
for purposes of determining the amount
of payment due. The amount of
payment determined by the contractor
in effectuating the ALJ’s or attorney
adjudicator’s decision is a new initial
determination under § 405.924.
(b) Decisions on requests for review of
a QIC dismissal—(1) General rule.
Unless the ALJ or attorney adjudicator
dismisses the request for review of a
QIC dismissal, or the QIC’s dismissal is
vacated and remanded, the ALJ or
attorney adjudicator will issue a written
decision affirming the QIC’s dismissal.
OMHA mails or otherwise transmits a
copy of the decision to all the parties
that received a copy of the QIC’s
dismissal.
(2) Content of the notice. The decision
must be written in a manner calculated
to be understood by a beneficiary and
must include—
(i) The specific reasons for the
determination, including a summary of
the evidence considered and applicable
authorities;
(ii) The procedures for obtaining
additional information concerning the
decision; and
(iii) Notification that the decision is
binding and is not subject to further
review, unless reopened and revised by
the ALJ or attorney adjudicator.
(c) Recommended decision. An ALJ or
attorney adjudicator issues a
recommended decision if he or she is
directed to do so in the Council’s
remand order. An ALJ or attorney
adjudicator may not issue a
recommended decision on his or her
own motion. The ALJ or attorney
adjudicator mails a copy of the
recommended decision to all the parties
at their last known address.
■ 46. Section 405.1048 is revised to read
as follows:
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§ 405.1048 The effect of an ALJ’s or
attorney adjudicator’s decision.
(a) The decision of the ALJ or attorney
adjudicator on a request for hearing is
binding on all parties unless—
(1) A party requests a review of the
decision by the Council within the
stated time period or the Council
reviews the decision issued by an ALJ
or attorney adjudicator under the
procedures set forth in § 405.1110, and
the Council issues a final decision or
remand order or the appeal is escalated
to Federal district court under the
provisions at § 405.1132 and the Federal
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(2) The decision is reopened and
revised by an ALJ or attorney
adjudicator or the Council under the
procedures explained in § 405.980;
(3) The expedited access to judicial
review process at § 405.990 is used;
(4) The ALJ’s or attorney adjudicator’s
decision is a recommended decision
directed to the Council and the Council
issues a decision; or
(5) In a case remanded by a Federal
district court, the Council assumes
jurisdiction under the procedures in
§ 405.1138 and the Council issues a
decision.
(b) The decision of the ALJ or attorney
adjudicator on a request for review of a
QIC dismissal is binding on all parties
unless the decision is reopened and
revised by the ALJ or attorney
adjudicator under the procedures in
§ 405.980.
§ 405.1050
[Amended]
47. Section 405.1050 is amended by—
a. Amending the section heading by
removing the phrase ‘‘an ALJ’’ and
adding ‘‘OMHA’’ in its place.
■ b. Amending the text of the section by
removing the phrase ‘‘pending before an
ALJ’’ and adding ‘‘pending before
OMHA’’ in its place, and by removing
the term ‘‘the ALJ’’ and adding
‘‘OMHA’’ in its place.
■ c. Amending the section heading and
the text of the section by removing the
term ‘‘MAC’’ each time it appears and
adding ‘‘Council’’ in its place.
■ 48. Section 405.1052 is revised to read
as follows:
■
■
§ 405.1052 Dismissal of a request for a
hearing before an ALJ or request for review
of a QIC dismissal.
(a) Dismissal of request for hearing.
An ALJ dismisses a request for a hearing
under any of the following conditions:
(1) Neither the party that requested
the hearing nor the party’s
representative appears at the time and
place set for the hearing, if—
(i) The party was notified before the
time set for the hearing that the request
for hearing might be dismissed for
failure to appear, the record contains
documentation that the party
acknowledged the notice of hearing, and
the party does not contact the ALJ
within 10 calendar days after the
hearing, or does contact the ALJ but the
ALJ determines the party did not
demonstrate good cause for not
appearing; or
(ii) The record does not contain
documentation that the party
acknowledged the notice of hearing, the
ALJ sends a notice to the party at the
last known address asking why the
party did not appear, and the party does
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not respond to the ALJ’s notice within
10 calendar days after receiving the
notice or does contact the ALJ but the
ALJ determines the party did not
demonstrate good cause for not
appearing.
(iii) In determining whether good
cause exists under paragraphs (a)(1)(i)
and (ii) of this section, the ALJ
considers any physical, mental,
educational, or linguistic limitations
(including any lack of facility with the
English language), that the party may
have.
(2) The person or entity requesting a
hearing has no right to it under
§ 405.1002.
(3) The party did not request a hearing
within the stated time period and the
ALJ or attorney adjudicator has not
found good cause for extending the
deadline, as provided in § 405.1014(e).
(4) The beneficiary whose claim is
being appealed died while the request
for hearing is pending and all of the
following criteria apply:
(i) The request for hearing was filed
by the beneficiary or the beneficiary’s
representative, and the beneficiary’s
surviving spouse or estate has no
remaining financial interest in the case.
In deciding this issue, the ALJ or
attorney adjudicator considers if the
surviving spouse or estate remains liable
for the services that were denied or a
Medicare contractor held the beneficiary
liable for subsequent similar services
under the limitation of liability
provisions based on the denial of the
services at issue.
(ii) No other individuals or entities
that have a financial interest in the case
wish to pursue an appeal under
§ 405.1002.
(iii) No other individual or entity filed
a valid and timely request for an ALJ
hearing in accordance to § 405.1014.
(5) The ALJ or attorney adjudicator
dismisses a hearing request entirely or
refuses to consider any one or more of
the issues because a QIC, an ALJ or
attorney adjudicator, or the Council has
made a previous determination or
decision under this subpart about the
appellant’s rights on the same facts and
on the same issue(s) or claim(s), and this
previous determination or decision has
become binding by either administrative
or judicial action.
(6) The appellant abandons the
request for hearing. An ALJ or attorney
adjudicator may conclude that an
appellant has abandoned a request for
hearing when OMHA attempts to
schedule a hearing and is unable to
contact the appellant after making
reasonable efforts to do so.
(7) The appellant’s request is not
complete in accordance with
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§ 405.1014(a)(1) or the appellant did not
send a copy of its request to the other
parties in accordance with
§ 405.1014(d), after the appellant is
provided with an opportunity to
complete the request and/or send a copy
of the request to the other parties.
(b) Dismissal of request for review of
a QIC dismissal. An ALJ or attorney
adjudicator dismisses a request for
review of a QIC dismissal under any of
the following conditions:
(1) The person or entity requesting a
review of a dismissal has no right to it
under § 405.1004.
(2) The party did not request a review
within the stated time period and the
ALJ or attorney adjudicator has not
found good cause for extending the
deadline, as provided in § 405.1014(e).
(3) The beneficiary whose claim is
being appealed died while the request
for review is pending and all of the
following criteria apply:
(i) The request for review was filed by
the beneficiary or the beneficiary’s
representative, and the beneficiary’s
surviving spouse or estate has no
remaining financial interest in the case.
In deciding this issue, the ALJ or
attorney adjudicator considers if the
surviving spouse or estate remains liable
for the services that were denied or a
Medicare contractor held the beneficiary
liable for subsequent similar services
under the limitation of liability
provisions based on the denial of the
services at issue.
(ii) No other individuals or entities
that have a financial interest in the case
wish to pursue an appeal under
§ 405.1004.
(iii) No other individual or entity filed
a valid and timely request for a review
of the QIC dismissal in accordance to
§ 405.1014.
(4) The appellant’s request is not
complete in accordance with
§ 405.1014(a)(1) or the appellant did not
send a copy of its request to the other
parties in accordance with
§ 405.1014(d), after the appellant is
provided with an opportunity to
complete the request and/or send a copy
of the request to the other parties.
(c) Withdrawal of request. At any time
before notice of the decision, dismissal,
or remand is mailed, if only one party
requested the hearing or review of the
QIC dismissal and that party asks to
withdraw the request, an ALJ or
attorney adjudicator may dismiss the
request for hearing or request for review
of a QIC dismissal. This request for
withdrawal may be submitted in
writing, or a request to withdraw a
request for hearing may be made orally
at a hearing before the ALJ. The request
for withdrawal must include a clear
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statement that the appellant is
withdrawing the request for hearing or
review of the QIC dismissal and does
not intend to further proceed with the
appeal. If an attorney or other legal
professional on behalf of a beneficiary
or other appellant files the request for
withdrawal, the ALJ or attorney
adjudicator may presume that the
representative has advised the appellant
of the consequences of the withdrawal
and dismissal.
(d) Notice of dismissal. OMHA mails
or otherwise transmits a written notice
of the dismissal of the hearing or review
request to all parties who were sent a
copy of the request for hearing or review
at their last known address. The notice
states that there is a right to request that
the ALJ or attorney adjudicator vacate
the dismissal action. The appeal will
proceed with respect to any other
parties who filed a valid request for
hearing or review regarding the same
claim or disputed matter.
(e) Vacating a dismissal. If good and
sufficient cause is established, the ALJ
or attorney adjudicator may vacate his
or her dismissal of a request for hearing
or review within 6 months of the date
of the notice of dismissal.
■ 49. Section 405.1054 is revised to read
as follows:
§ 405.1054 Effect of dismissal of a request
for a hearing or request for review of QIC
dismissal.
(a) The dismissal of a request for a
hearing is binding, unless it is vacated
by the Council under § 405.1108(b), or
vacated by the ALJ or attorney
adjudicator under § 405.1052(e).
(b) The dismissal of a request for
review of a QIC dismissal of a request
for reconsideration is binding and not
subject to further review unless it is
vacated by the ALJ or attorney
adjudicator under § 405.1052(e).
■ 50. Section 405.1056 is added before
the undesignated center heading
‘‘Applicability of Medicare Coverage
Policies’’ to read as follows:
§ 405.1056 Remands of requests for
hearing and requests for review.
(a) Missing appeal determination or
case record. (1) If an ALJ or attorney
adjudicator requests an official copy of
a missing redetermination or
reconsideration for an appealed claim in
accordance with § 405.1034, and the
QIC or another contractor does not
furnish the copy within the time frame
specified in § 405.1034, the ALJ or
attorney adjudicator may issue a remand
directing the QIC or other contractor to
reconstruct the record or, if it is not able
to do so, initiate a new appeal
adjudication.
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(2) If the QIC does not furnish the case
file for an appealed reconsideration, an
ALJ or attorney adjudicator may issue a
remand directing the QIC to reconstruct
the record or, if it is not able to do so,
initiate a new appeal adjudication.
(3) If the QIC or another contractor is
able to reconstruct the record for a
remanded case and returns the case to
OMHA, the case is no longer remanded
and the reconsideration is no longer
vacated, and any adjudication period
that applies to the appeal in accordance
with § 405.1016 is extended by the
period between the date of the remand
and the date that case is returned to
OMHA.
(b) No redetermination. If an ALJ or
attorney adjudicator finds that the QIC
issued a reconsideration that addressed
coverage or payment issues related to
the appealed claim and no
redetermination of the claim was made
(if a redetermination was required under
this subpart) or the request for
redetermination was dismissed, the
reconsideration will be remanded to the
QIC, or its successor to re-adjudicate the
request for reconsideration.
(c) Requested remand—(1) Request
contents and timing. At any time prior
to an ALJ or attorney adjudicator issuing
a decision or dismissal, the appellant
and CMS or one of its contractors may
jointly request a remand of the appeal
to the entity that conducted the
reconsideration. The request must
include the reasons why the appeal
should be remanded and indicate
whether remanding the case will likely
resolve the matter in dispute.
(2) Granting the request. An ALJ or
attorney adjudicator may grant the
request and issue a remand if he or she
determines that remanding the case will
likely resolve the matter in dispute.
(d) Remanding a QIC’s dismissal of a
request for reconsideration. Consistent
with § 405.1004(b), an ALJ or attorney
adjudicator will remand a case to the
appropriate QIC if the ALJ or attorney
adjudicator determines that a QIC’s
dismissal of a request for
reconsideration was in error.
(e) Relationship to local and national
coverage determination appeals
process. (1) An ALJ or attorney
adjudicator remands an appeal to the
QIC that made the reconsideration if the
appellant is entitled to relief pursuant to
§§ 426.460(b)(1), 426.488(b), or
426.560(b)(1) of this chapter.
(2) Unless the appellant is entitled to
relief pursuant to §§ 426.460(b)(1),
426.488(b), or 426.560(b)(1) of this
chapter, the ALJ or attorney adjudicator
applies the LCD or NCD in place on the
date the item or service was provided.
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(f) Notice of a remand. OMHA mails
or otherwise transmits a written notice
of the remand of the request for hearing
or request for review to all of the parties
who were sent a copy of the request at
their last known address, and CMS or a
contractor that elected to be a
participant in the proceedings or party
to the hearing. The notice states that
there is a right to request that the Chief
ALJ or a designee review the remand.
(g) Review of remand. Upon a request
by a party or CMS or one of its
contractors filed within 30 calendar
days of receiving a notice of remand, the
Chief ALJ or designee will review the
remand, and if the remand is not
authorized by this section, vacate the
remand order. The determination on a
request to review a remand order is
binding and not subject to further
review.
■ 51. Section 405.1058 is added before
the undesignated center heading
‘‘Applicability of Medicare Coverage
Policies’’ to read as follows:
§ 405.1063 Applicability of laws,
regulations, CMS Rulings, and precedential
decisions.
A remand of a request for hearing or
request for review is binding unless
vacated by the Chief ALJ or a designee
in accordance with § 405.1056(g).
(a) All laws and regulations pertaining
to the Medicare and Medicaid programs,
including, but not limited to Titles XI,
XVIII, and XIX of the Social Security
Act and applicable implementing
regulations, are binding on ALJs and
attorney adjudicators, and the Council.
(b) CMS Rulings are published under
the authority of the Administrator, CMS.
Consistent with § 401.108 of this
chapter, rulings are binding on all CMS
components, on all HHS components
that adjudicate matters under the
jurisdiction of CMS, and on the Social
Security Administration to the extent
that components of the Social Security
Administration adjudicate matters
under the jurisdiction of CMS.
(c) Precedential decisions designated
by the Chair of the Departmental
Appeals Board in accordance with
§ 401.109 of this chapter, are binding on
all CMS components, all HHS
components that adjudicate matters
under the jurisdiction of CMS, and on
the Social Security Administration to
the extent that components of the Social
Security Administration adjudicate
matters under the jurisdiction of CMS.
§ 405.1060
§ 405.1064
§ 405.1058
Effect of a remand.
[Amended]
52. Section 405.1060 is amended by—
a. Amending paragraph (a)(4) by
removing the term ‘‘ALJs’’ and adding
‘‘ALJs and attorney adjudicators’’ in its
place.
■ b. Amending paragraphs (a)(4), (c)
paragraph heading, (c)(1), and (c)(2) by
removing the term ‘‘MAC’’ and adding
‘‘Council’’ in its place.
■ c. Amending paragraphs (b) paragraph
heading, (b)(1), and (b)(2) by removing
the term ‘‘ALJ’’ and adding ‘‘ALJ or
attorney adjudicator’’ in its place.
■
■
§ 405.1062
[Amended]
53. Section 405.1062 is amended by—
a. Amending the section heading and
paragraphs (a) and (b) by removing the
term ‘‘MAC’’ each time it appears and
adding ‘‘Council’’ in its place.
■ b. Amending the section heading and
paragraph (b) by removing the term
‘‘ALJ’’ each time it appears and adding
‘‘ALJ or attorney adjudicator’’ in its
place.
■ c. Amending paragraph (a) by
removing the term ‘‘ALJs’’ and adding
‘‘ALJs and attorney adjudicators’’ in its
place.
■ d. Amending paragraph (c) by
removing the phrase ‘‘An ALJ or MAC’’
and adding ‘‘An ALJ or attorney
adjudicator or the Council’’ in its place.
■ 54. Section 405.1063 is revised to read
as follows:
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[Removed]
55. Section 405.1064 is removed.
56. Section 405.1100 is revised to read
as follows:
■
■
§ 405.1100 Medicare Appeals Council
review: General.
(a) The appellant or any other party to
an ALJ’s or attorney adjudicator’s
decision or dismissal may request that
the Council review the ALJ’s or attorney
adjudicator’s decision or dismissal.
(b) Under circumstances set forth in
§§ 405.1016 and 405.1108, the appellant
may request that a case be escalated to
the Council for a decision even if the
ALJ or attorney adjudicator has not
issued a decision, dismissal, or remand
in his or her case.
(c) When the Council reviews an
ALJ’s or attorney adjudicator’s decision,
it undertakes a de novo review. The
Council issues a final decision or
dismissal order or remands a case to the
ALJ or attorney adjudicator within 90
calendar days of receipt of the
appellant’s request for review, unless
the 90 calendar day period is extended
as provided in this subpart.
(d) When deciding an appeal that was
escalated from the OMHA level to the
Council, the Council will issue a final
decision or dismissal order or remand
the case to the OMHA Chief ALJ within
180 calendar days of receipt of the
appellant’s request for escalation, unless
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the 180 calendar day period is extended
as provided in this subpart.
■ 57. Section 405.1102 is revised to read
as follows:
§ 405.1102 Request for Council review
when ALJ or attorney adjudicator issues
decision or dismissal.
(a)(1) A party to a decision or
dismissal issued by an ALJ or attorney
adjudicator may request a Council
review if the party files a written request
for a Council review within 60 calendar
days after receipt of the ALJ’s or
attorney adjudicator’s decision or
dismissal.
(2) For purposes of this section, the
date of receipt of the ALJ’s or attorney
adjudicator’s decision or dismissal is
presumed to be 5 calendar days after the
date of the notice of the decision or
dismissal, unless there is evidence to
the contrary.
(3) The request is considered as filed
on the date it is received by the entity
specified in the notice of the ALJ’s or
attorney adjudicator’s action.
(b) A party requesting a review may
ask that the time for filing a request for
Council review be extended if—
(1) The request for an extension of
time is in writing;
(2) It is filed with the Council; and
(3) It explains why the request for
review was not filed within the stated
time period. If the Council finds that
there is good cause for missing the
deadline, the time period will be
extended. To determine whether good
cause exists, the Council uses the
standards outlined at § 405.942(b)(2)
and (3).
(c) A party does not have the right to
seek Council review of an ALJ’s or
attorney adjudicator’s remand to a QIC,
affirmation of a QIC’s dismissal of a
request for reconsideration, or dismissal
of a request for review of a QIC
dismissal.
(d) For purposes of requesting Council
review (§§ 405.1100 through 405.1140),
unless specifically excepted, the term
‘‘party’’, includes CMS where CMS has
entered into a case as a party according
to § 405.1012. The term, ‘‘appellant,’’
does not include CMS, where CMS has
entered into a case as a party according
to § 405.1012.
§ 405.1104
[Removed]
58. Section 405.1104 is removed.
59. Section 405.1106 is revised to read
as follows:
■
■
§ 405.1106 Where a request for review or
escalation may be filed.
(a) When a request for a Council
review is filed after an ALJ or attorney
adjudicator has issued a decision or
dismissal, the request for review must
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be filed with the entity specified in the
notice of the ALJ’s or attorney
adjudicator’s action. The appellant must
also send a copy of the request for
review to the other parties to the ALJ or
attorney adjudicator decision or
dismissal who received notice of the
decision or dismissal. Failure to copy
the other parties tolls the Council’s
adjudication deadline set forth in
§ 405.1100 until all parties to the ALJ or
attorney adjudicator decision or
dismissal receive notice of the request
for Council review. If the request for
review is timely filed with an entity
other than the entity specified in the
notice of the ALJ’s or attorney
adjudicator’s action, the Council ’s
adjudication period to conduct a review
begins on the date the request for review
is received by the entity specified in the
notice of the ALJ’s or attorney
adjudicator’s action. Upon receipt of a
request for review from an entity other
than the entity specified in the notice of
the ALJ’s or attorney adjudicator’s
action, the Council sends written notice
to the appellant of the date of receipt of
the request and commencement of the
adjudication timeframe.
(b) If an appellant files a request to
escalate an appeal to the Council level
because the ALJ or attorney adjudicator
has not completed his or her action on
the request for hearing within an
applicable adjudication period under
§ 405.1016, the request for escalation
must be filed with OMHA and the
appellant must also send a copy of the
request for escalation to the other
parties who were sent a copy of the QIC
reconsideration. Failure to copy the
other parties tolls the Council’s
adjudication deadline set forth in
§ 405.1100 until all parties who were
sent a copy of the QIC reconsideration
receive notice of the request for
escalation. In a case that has been
escalated from OMHA, the Council’s
180 calendar day period to issue a final
decision, dismissal order, or remand
order begins on the date the request for
escalation is received by the Council.
§ 405.1108
[Amended]
60. Section 405.1108 is amended by—
a. Amending the section heading and
paragraphs (a), (b), (c), (d) introductory
text, (d)(2), and (4) by removing the term
‘‘MAC’’ each time it appears and adding
‘‘Council’’ in its place.
■ b. Amending paragraphs (a), (b), (c),
(d)(1), and (5) by removing the term
‘‘ALJ’’ each time it appears and adding
‘‘ALJ or attorney adjudicator’’ in its
place.
■ c. Amending paragraphs (a) and (b) by
removing the term ‘‘ALJ’s’’ each time it
■
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appears and adding ‘‘ALJ’s or attorney
adjudicator’s’’ in its place.
■ d. Amending paragraph (b) by
removing the first use of ‘‘dismissal’’ in
the paragraph and adding ‘‘dismissal of
a request for a hearing’’ in its place.
■ e. Amending paragraph (d)
introductory text by removing the term
‘‘ALJ level’’ and adding ‘‘OMHA level’’
in its place.
■ f. Amending paragraph (d)(3) by
removing the phrase ‘‘to an ALJ’’ and
adding ‘‘to OMHA’’ in its place.
■ 61. Section 405.1110 is revised to read
as follows:
§ 405.1110
motion.
Council reviews on its own
(a) General rule. The Council may
decide on its own motion to review a
decision or dismissal issued by an ALJ
or attorney adjudicator. CMS or any of
its contractors may refer a case to the
Council for it to consider reviewing
under this authority anytime within 60
calendar days after the date of an ALJ’s
or attorney adjudicator’s decision or
dismissal.
(b) Referral of cases. (1) CMS or any
of its contractors may refer a case to the
Council if, in their view, the decision or
dismissal contains an error of law
material to the outcome of the claim or
presents a broad policy or procedural
issue that may affect the public interest.
CMS may also request that the Council
take own motion review of a case if—
(i) CMS or its contractor participated
in the appeal at the OMHA level; and
(ii) In CMS’ view, the ALJ’s or
attorney adjudicator’s decision or
dismissal is not supported by the
preponderance of evidence in the record
or the ALJ or attorney adjudicator
abused his or her discretion.
(2) CMS’ referral to the Council is
made in writing and must be filed with
the Council no later than 60 calendar
days after the ALJ’s or attorney
adjudicator’s decision or dismissal is
issued. The written referral will state
the reasons why CMS believes the
Council must review the case on its own
motion. CMS will send a copy of its
referral to all parties to the ALJ’s or
attorney adjudicator’s action who
received a copy of the hearing decision
under § 405.1046(a) or the notice of
dismissal under § 405.1052(d), and to
the OMHA Chief ALJ. Parties to the
ALJ’s or attorney adjudicator’s action
may file exceptions to the referral by
submitting written comments to the
Council within 20 calendar days of the
referral notice. A party submitting
comments to the Council must send
such comments to CMS and all other
parties to the ALJ’s or attorney
adjudicator’s action who received a
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copy of the hearing decision under
§ 405.1046(a) or the notice of dismissal
under § 405.1052(d).
(c) Standard of review—(1) Referral by
CMS after participation at the OMHA
level. If CMS or its contractor
participated in an appeal at the OMHA
level, the Council exercises its own
motion authority if there is an error of
law material to the outcome of the case,
an abuse of discretion by the ALJ or
attorney adjudicator, the decision is not
consistent with the preponderance of
the evidence of record, or there is a
broad policy or procedural issue that
may affect the general public interest. In
deciding whether to accept review
under this standard, the Council will
limit its consideration of the ALJ’s or
attorney adjudicator’s action to those
exceptions raised by CMS.
(2) Referral by CMS when CMS did
not participate in the OMHA
proceedings or appear as a party. The
Council will accept review if the
decision or dismissal contains an error
of law material to the outcome of the
case or presents a broad policy or
procedural issue that may affect the
general public interest. In deciding
whether to accept review, the Council
will limit its consideration of the ALJ’s
or attorney adjudicator’s action to those
exceptions raised by CMS.
(d) Council’s action. If the Council
decides to review a decision or
dismissal on its own motion, it will mail
the results of its action to all the parties
to the hearing and to CMS if it is not
already a party to the hearing. The
Council may adopt, modify, or reverse
the decision or dismissal, may remand
the case to an ALJ or attorney
adjudicator for further proceedings or
may dismiss a hearing request. The
Council must issue its action no later
than 90 calendar days after receipt of
the CMS referral, unless the 90 calendar
day period has been extended as
provided in this subpart. The Council
may not, however, issue its action
before the 20 calendar day comment
period has expired, unless it determines
that the agency’s referral does not
provide a basis for reviewing the case.
If the Council does not act within the
applicable adjudication deadline, the
ALJ’s or attorney adjudicator’s decision
or dismissal is binding on the parties to
the ALJ’s or attorney adjudicator’s
action.
■ 62. Section 405.1112 is revised to read
as follows:
§ 405.1112
Content of request for review.
(a) The request for Council review
must be filed with the entity specified
in the notice of the ALJ’s or attorney
adjudicator’s action. The request for
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review must be in writing and may be
made on a standard form. A written
request that is not made on a standard
form is accepted if it contains the
beneficiary’s name; Medicare health
insurance claim number; the specific
service(s) or item(s) for which the
review is requested; the specific date(s)
of service; the date of the ALJ’s or
attorney adjudicator’s decision or
dismissal order, if any; and the name
and signature of the party or the
representative of the party; and any
other information CMS may decide.
(b) The request for review must
identify the parts of the ALJ’s or
attorney adjudicator’s action with which
the party requesting review disagrees
and explain why he or she disagrees
with the ALJ’s or attorney adjudicator’s
decision, dismissal, or other
determination being appealed. For
example, if the party requesting review
believes that the ALJ’s or attorney
adjudicator’s action is inconsistent with
a statute, regulation, CMS Ruling, or
other authority, the request for review
should explain why the appellant
believes the action is inconsistent with
that authority.
(c) The Council will limit its review
of an ALJ’s or attorney adjudicator’s
actions to those exceptions raised by the
party in the request for review, unless
the appellant is an unrepresented
beneficiary. For purposes of this section
only, we define a representative as
anyone who has accepted an
appointment as the beneficiary’s
representative, except a member of the
beneficiary’s family, a legal guardian, or
an individual who routinely acts on
behalf of the beneficiary, such as a
family member or friend who has a
power of attorney.
§ 405.1118
[Amended]
65. Section 405.1118 is amended by—
a. Removing the term ‘‘MAC’’ each
time it appears in the heading and text
and adding ‘‘Council’’ in its place.
■ b. Removing the phrase ‘‘ALJ hearing’’
and adding ‘‘ALJ’s or attorney
adjudicator’s action’’ in its place.
■ c. Removing the phrase ‘‘the exhibits
list’’ and adding ‘‘any index of the
administrative record’’ in its place.
■ d. Removing the term ‘‘tape’’ and
adding ‘‘audio recording’’ in its place.
■ e. Removing the term ‘‘MAC’s’’ and
adding ‘‘Council’s’’ in its place.
heading, (d)(1) and (2), (e) paragraph
heading, and (e)(1) and (2) by removing
the term ‘‘MAC’’ each time it appears
and adding ‘‘Council’’ in its place.
■ b. Amending paragraph (b) by
removing the term ‘‘MAC’s’’ and adding
‘‘Council’s’’ in its place.
■ c. Amending paragraphs (a), (b), (c),
(d) paragraph heading, and (e)(2) by
removing the term ‘‘ALJ’’ each time it
appears and adding ‘‘ALJ or attorney
adjudicator’’ in its place.
■ d. Amending paragraph (e)(2) by
adding ‘‘if applicable’’ after the word
‘‘rehearing’’.
§ 405.1120
§ 405.1128
■
■
[Amended]
66. Section 405.1120 is amended in
the heading and text by removing the
term ‘‘MAC’’ each time it appears and
adding ‘‘Council’’ in its place.
■
§ 405.1122
[Amended]
63. Section 405.1114 is amended by—
a. Amending the introductory text and
paragraphs (b) and (c)(1) by removing
the term ‘‘MAC’’ each time it appears
and adding ‘‘Council’’ in its place.
■ b. Amending paragraph (c)(3) by
removing the phrase ‘‘ALJ hearing’’ and
adding ‘‘ALJ’s or attorney adjudicator’s
action’’ in its place.
67. Section 405.1122 is amended by—
a. Amending the section heading and
paragraphs (a) paragraph heading, (a)(1)
and (2), (b) paragraph heading, (b)(1)
and (2), (c)(1), (2), and (3) introductory
text, (c)(3)(ii), (d)(1) and (3), (e)(1), (2),
(3), and (4), and (f)(1), (2), and (3) by
removing the term ‘‘MAC’’ each time it
appears and adding ‘‘Council’’ in its
place.
■ b. Amending paragraphs (e)(5) and (6),
and (f)(2) by removing the term
‘‘MAC’s’’ and adding ‘‘Council’s’’ in its
place.
■ c. Amending paragraph (a)(1) by
removing the term ‘‘hearing decision’’
and adding ‘‘ALJ’s or attorney
adjudicator’s decision’’ in its place.
■ d. Amending paragraphs (a)(1) and
(b)(1) by removing the term ‘‘ALJ level’’
and adding ‘‘OMHA level’’ in its place.
■ e. Amending paragraphs (a)(1) and (2),
(b)(1) and (2), (c)(2), (c)(3) introductory
text, and (c)(3)(i) and (ii) by removing
the term ‘‘ALJ’’ each time it appears and
adding ‘‘ALJ or attorney adjudicator’’ in
its place.
■ f. Amending paragraphs (a) paragraph
heading and (a)(1) by removing the term
‘‘ALJ’s’’ and adding ‘‘ALJ’s or attorney
adjudicator’s’’ in its place.
■ g. Amending paragraph (a)(2) by
removing the term ‘‘hearing record’’ and
adding ‘‘administrative record’’ in its
place.
§ 405.1116
§ 405.1124
§ 405.1114
[Amended]
■
sradovich on DSK3GDR082PROD with PROPOSALS3
■
[Amended]
64. Section 405.1116 is amended by—
■ a. Removing the term ‘‘MAC’’ each
time it appears in the heading and text
and adding ‘‘Council’’ in its place.
■ b. Removing the term ‘‘MAC’s’’ and
adding ‘‘Council’s’’ in its place.
■ c. Removing the term ‘‘ALJ’’ and
adding ‘‘ALJ or attorney adjudicator’’ in
its place.
■
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■
■
[Amended]
68. Section 405.1124 is amended by
removing the term ‘‘MAC’’ each time it
appears and adding ‘‘Council’’ in its
place.
■
§ 405.1126
[Amended]
69. Section 405.1126 is amended by—
a. Amending the section heading and
paragraphs (a), (b), (c), (d) paragraph
■
■
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[Amended]
70. Section 405.1128 is amended by—
a. Amending the section heading and
paragraphs (a), (b), and (c) by removing
the term ‘‘MAC’’ each time it appears
and adding ‘‘Council’’ in its place.
■ b. Amending paragraph (a) by
removing the term ‘‘ALJ’’ and adding
‘‘ALJ or attorney adjudicator’’ in its
place.
■ c. Amending paragraph (b) by
removing the term ‘‘ALJ hearing
decision’’ and adding ‘‘ALJ’s or attorney
adjudicator’s decision’’ in its place.
■
■
§ 405.1130
[Amended]
71. Section 405.1130 is amended in
the section heading and text by
removing the term ‘‘MAC’s’’ each time
it appears and adding ‘‘Council’s’’ in its
place.
■
§ 405.1132
[Amended]
72. Section 405.1132 is amended by—
a. Amending paragraphs (a)
introductory text, (a)(2), and (b) by
removing the term ‘‘MAC’’ each time it
appears and adding ‘‘Council’’ in its
place.
■ b. Amending paragraph (b) by
removing the term ‘‘MAC’s’’ and adding
‘‘Council’s’’ in its place.
■ c. Amending paragraphs (a)
introductory text, (a)(1), and (b) by
removing the term ‘‘ALJ’’ each time it
appears and adding ‘‘ALJ or attorney
adjudicator’’ in its place.
■
■
§ 405.1134
[Amended]
73. Section 405.1134 is amended by—
a. Amending paragraph (a) by
removing the term ‘‘MAC’s’’ and adding
‘‘Council’s’’ in its place.
■ b. Amending paragraphs (b)(3) and (c)
by removing the term ‘‘MAC’’ and
adding ‘‘Council’’ in its place.
■
■
§ 405.1136
[Amended]
74. Section 405.1136 is amended by—
a. Amending paragraphs (a)(1) and (2),
and (c)(3) by removing the term ‘‘MAC’’
each time it appears and adding
‘‘Council’’ in its place.
■ b. Amending paragraph (a)(1) by
removing the term ‘‘ALJ’s’’ and adding
■
■
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‘‘ALJ’s or attorney adjudicator’s’’ in its
place.
■ c. Amending paragraphs (a)(2) and
(c)(2) by removing the term ‘‘MAC’s’’
each time it appears and adding
‘‘Council’s’’ in its place.
■ d. Amending paragraph (c)(3) by
removing the term ‘‘ALJ’’ and adding
‘‘ALJ or attorney adjudicator’’ in its
place.
§ 405.1138
[Amended]
75. Section 405.1138 is amended by—
a. Removing the term ‘‘MAC’’ each
time it appears and adding ‘‘Council’’ in
its place.
■ b. Removing the term ‘‘ALJ’’ and
adding ‘‘ALJ or attorney adjudicator’’ in
its place.
■
■
§ 405.1140
[Amended]
PART 422—MEDICARE ADVANTAGE
PROGRAM
78. The authority citation for part 422
continues to read as follows:
■
Authority: Secs. 1102 and 1871 of the
Social Security Act (42 U.S.C. 1302 and
1395hh).
§ 422.561
■
§ 422.562
■
*
76. Section 405.1140 is amended by—
a. Amending the section heading and
paragraphs (a)(1), (2), and (3), (b)(1), (2),
and (3), (c) paragraph heading, (c)(1),
(3), and (4), and (d) by removing the
term ‘‘MAC’’ each time it appears and
adding ‘‘Council’’ in its place.
■ b. Amending the section heading and
paragraphs (a)(1), (2), and (3), (b)
paragraph heading, (b)(1), (2), and (3),
(c)(1) and (4), and (d) by removing the
term ‘‘ALJ’’ each time it appears and
adding ‘‘ALJ or attorney adjudicator’’ in
its place.
■ c. Amending paragraph (d) by
removing the term ‘‘ALJ’s’’ and adding
‘‘ALJ’s or attorney adjudicator’s’’ in its
place.
■ 77. Section 405.1204 is amended by
revising paragraphs (c)(4)(iii) and (c)(5)
to read as follows:
§ 405.1204
Expedited reconsiderations.
*
sradovich on DSK3GDR082PROD with PROPOSALS3
[Amended]
79. Section 422.561 is amended, in
the definition of ‘‘Appeal,’’ by removing
the phrase ‘‘Medicare Appeals Council
(MAC)’’ and adding ‘‘Medicare Appeals
Council (Council)’’ in its place.
■ 80. Section 422.562 is amended by—
■ a. Amending paragraph (b)(4)(v) by
removing the term ‘‘MAC’’ and adding
‘‘Council’’ in its place.
■ b. Revising paragraphs (c)(1) and (d) to
read as follows:
■
*
*
*
*
(c) * * *
(4) * * *
(iii) Information about the
beneficiary’s right to appeal the QIC’s
reconsideration decision to OMHA for
an ALJ hearing in accordance with
subpart I of this part, including how to
request an appeal and the time period
for doing so.
(5) Unless the beneficiary requests an
extension in accordance with paragraph
(c)(6) of this section, if the QIC does not
issue a decision within 72 hours of
receipt of the request, the QIC must
notify the beneficiary of his or her right
to have the case escalated to OMHA for
an ALJ hearing in accordance with
subpart I of this part, if the amount
remaining in controversy after the QIO
determination meets the requirements
for an ALJ hearing under § 405.1006.
*
*
*
*
*
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General provisions.
*
*
*
*
(c) * * *
(1) If an enrollee receives immediate
QIO review (as provided in § 422.622) of
a determination of noncoverage of
inpatient hospital care the enrollee is
not entitled to review of that issue by
the MA organization.
*
*
*
*
*
(d) When other regulations apply.
Unless this subpart provides otherwise,
the regulations in part 405 of this
chapter (concerning the administrative
review and hearing processes and
representation of parties under titles II
and XVIII of the Act) apply under this
subpart to the extent they are
appropriate, unless the part 405
regulation implements a provision of
section 1869 of the Act that is not also
in section 1852(g)(5) of the Act.
■ 81. Section 422.594 is amended by
revising paragraph (b)(2) to read as
follows:
§ 422.594 Notice of reconsidered
determination by the independent entity.
*
*
*
*
*
(b) * * *
(2) If the reconsidered determination
is adverse (that is, does not completely
reverse the MA organization’s adverse
organization determination), inform the
parties of their right to an ALJ hearing
if the amount in controversy meets the
requirements of § 422.600;
*
*
*
*
*
■ 82. Section 422.602 is amended by
revising paragraph (b) to read as follows:
§ 422.602
Request for an ALJ hearing.
*
*
*
*
*
(b) When to file a request. (1) Except
when an ALJ or attorney adjudicator
extends the time frame as provided in
part 405 of this chapter, a party must
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file a request for a hearing within 60
calendar days of receipt of the notice of
a reconsidered determination. The time
and place for a hearing before an ALJ
will be set in accordance with
§ 405.1020.
(2) For purposes of this section, the
date of receipt of the reconsideration is
presumed to be 5 calendar days after the
date of the notice of the reconsidered
determination, unless there is evidence
to the contrary.
*
*
*
*
*
■ 83. Section 422.608 is revised to read
as follows:
§ 422.608 Medicare Appeals Council
(Council) review.
Any party to the ALJ’s or attorney
adjudicator’s decision or dismissal,
including the MA organization, who is
dissatisfied with the decision or
dismissal, may request that the Council
review the decision or dismissal. The
regulations under part 405 of this
chapter regarding Council review apply
to matters addressed by this subpart to
the extent that they are appropriate,
unless the part 405 regulation
implements a provision of section 1869
of the Act that is not also in section
1852(g)(5) of the Act.
§ 422.612
[Amended]
84. Section 422.612 is amended by—
a. Amending paragraph (a) paragraph
heading and introductory text by
removing the term ‘‘ALJ’s’’ and adding
‘‘ALJ’s or attorney adjudicator’s’’ in its
place.
■ b. Amending paragraph (a)(1) by
removing the term ‘‘Board’’ and adding
‘‘Council’’ in its place.
■ c. Amending paragraph (b) by
removing the term ‘‘MAC’’ each time it
appears and adding ‘‘Council’’ in its
place.
■
■
§ 422.616
[Amended]
85. Section 422.616 is amended in
paragraph (a) by removing the terms
‘‘ALJ’’ and ‘‘MAC’’ and adding in their
place ‘‘ALJ or attorney adjudicator’’ and
‘‘Council’’ respectively.
■
§ 422.618
[Amended]
86. Section 422.618 is amended by—
a. Amending paragraph (c)(1) by
removing the term ‘‘ALJ’’ and adding
‘‘ALJ or attorney adjudicator’’ in its
place.
■ b. Amending paragraph (c)(2) by
removing the terms ‘‘Medicare Appeals
Council’’, ‘‘Medicare Appeals Council
(the Board)’’, and ‘‘Board’’ and adding
‘‘Council’’ in their place.
■
■
§ 422.619
■
[Amended]
87. Section 422.619 is amended by—
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a. Amending paragraph (c)(1) by
removing the term ‘‘ALJ’’ and adding
‘‘ALJ or attorney adjudicator’’ in its
place.
■ b. Amending paragraph (c)(2) by
removing the terms ‘‘Medicare Appeals
Council’’, ‘‘Medicare Appeals Council
(the Board)’’, and ‘‘Board’’ and adding
‘‘Council’’ in their place.
■
§ 422.622
[Amended]
88. Section 422.622 (g)(2) is amended
by removing the phrase ‘‘may appeal to
an ALJ, the MAC, or a federal court’’
and adding ‘‘may appeal to OMHA for
an ALJ hearing, the Council, or a federal
court’’ in its place.
■
§ 422.626
[Amended]
89. Section 422.626(g)(3) is amended
by removing the phrase ‘‘to an ALJ, the
MAC, or a Federal court’’ and adding
‘‘to OMHA for an ALJ hearing, the
Council, or a Federal court’’ in its place.
■
PART 423—VOLUNTARY MEDICARE
PRESCRIPTION DRUG BENEFIT
90. The authority citation for part 423
continues to read as follows:
■
Authority: Sections 1102, 1106, 1860D–1
through 1860D–42, and 1871 of the Social
Security Act (42 U.S.C. 1302, 1306, 1395w–
101 through 1395w–152, and 1395hh).
§ 423.560
[Amended]
91. Section 423.560 is amended by
amending the definition of ‘‘Appeal’’ by
removing the term ‘‘Medicare Appeals
Council (MAC)’’ and adding ‘‘Medicare
Appeals Council (Council) in its place.
■ 92. Section 423.562 is amended by
revising paragraphs (b)(4)(v) and (vi) to
read as follows:
■
§ 423.562
General provisions.
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*
*
*
*
*
(b) * * *
(4) * * *
(v) If the ALJ or attorney adjudicator
affirms the IRE’s adverse coverage
determination, in whole or in part, the
right to request Council review of the
ALJ’s or attorney adjudicator’s decision,
as specified in § 423.1974.
(vi) If the Council affirms the ALJ’s or
attorney adjudicator’s adverse coverage
determination, in whole or in part, the
right to judicial review of the decision
if the amount in controversy meets the
requirements in § 423.1976.
*
*
*
*
*
Subpart U—Reopening, ALJ Hearings
and ALJ and Attorney Adjudicator
Decisions, MAC Review, and Judicial
Review
93. The heading of subpart U is
revised to read as set forth above.
■
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94. Section 423.1968 is revised to read
as follows:
■
§ 423.1968
Scope.
This subpart sets forth the
requirements relating to the following:
(a) Part D sponsors, the Part D IRE,
ALJs and attorney adjudicators, and the
Council with respect to reopenings.
(b) ALJs with respect to hearings and
decisions or decisions of attorney
adjudicators if no hearing is conducted.
(c) The Council with respect to review
of Part D appeals.
(d) Part D enrollees’ rights with
respect to reopenings, ALJ hearings and
ALJ or attorney adjudicator reviews,
Council reviews, and judicial review by
a Federal District Court.
■ 95. Section 423.1970 is amended by
revising paragraphs (c)(1)(ii) and (iii),
and (c)(2)(ii) and (iii) to read as follows:
§ 423.1970
Right to an ALJ hearing.
*
*
*
*
*
(c) * * *
(1) * * *
(ii) The enrollee requests aggregation
at the same time the requests for hearing
are filed, and the request for aggregation
and requests for hearing are filed within
60 calendar days after receipt of the
notice of reconsideration for each of the
reconsiderations being appealed, unless
the deadline to file one or more of the
requests for hearing has been extended
in accordance with § 423.2014(d); and
(iii) The appeals the enrollee seeks to
aggregate involve the delivery of
prescription drugs to a single enrollee,
as determined by an ALJ or attorney
adjudicator. Only an ALJ may determine
the appeals the enrollee seeks to
aggregate do not involve the delivery of
prescription drugs to a single enrollee.
(2) * * *
(ii) The enrollees request aggregation
at the same time the requests for hearing
are filed, and the request for aggregation
and requests for hearing are filed within
60 calendar days after receipt of the
notice of reconsideration for each of the
reconsiderations being appealed, unless
the deadline to file one or more of the
requests for hearing has been extended
in accordance with § 423.2014(d); and
(iii) The appeals the enrollees seek to
aggregate involve the same prescription
drugs, as determined by an ALJ or
attorney adjudicator. Only an ALJ may
determine the appeals the enrollees seek
to aggregate do not involve the same
prescription drugs.
■ 96. Section 423.1972 is amended by
revising paragraphs (a), (b), and (c)(1) to
read as follows:
§ 423.1972
Request for an ALJ hearing.
(a) How and where to file a request.
The enrollee must file a written request
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for a hearing with the OMHA office
specified in the IRE’s reconsideration
notice.
(b) When to file a request. (1) Except
when an ALJ or attorney adjudicator
extends the timeframe as provided in
§ 423.2014(d), the enrollee must file a
request for a hearing within 60 calendar
days of receipt of the notice of an IRE
reconsideration determination. The time
and place for a hearing before an ALJ
will be set in accordance with
§ 423.2020
(2) For purposes of this section, the
date of receipt of the reconsideration
determination is presumed to be 5
calendar days after the date of the
written reconsideration determination,
unless there is evidence to the contrary.
(c) * * *
(1) If a request for a hearing clearly
shows that the amount in controversy is
less than that required under
§ 423.1970, the ALJ or attorney
adjudicator dismisses the request.
*
*
*
*
*
■ 97. Section 423.1974 is revised to read
as follows:
§ 423.1974
Council review.
An enrollee who is dissatisfied with
an ALJ’s or attorney adjudicator’s
decision or dismissal may request that
the Council review the ALJ’s or attorney
adjudicator’s decision or dismissal as
provided in § 423.2102.
§ 423.1976
[Amended]
98. Section 423.1976 is amended by—
a. Amending paragraph (a) paragraph
heading and introductory text by
removing the term ‘‘ALJ’s’’ and adding
‘‘ALJ’s or attorney adjudicator’s’’ in its
place.
■ b. Amending paragraphs (a)(1) and (b)
by removing the term ‘‘MAC’’ each time
it appears and adding ‘‘Council’’ in its
place.
■
■
§ 423.1978
[Amended]
99. Section 423.1978(a) is amended by
removing the phrase ‘‘ALJ or the MAC’’
and adding ‘‘ALJ or attorney adjudicator
or the Council’’ in its place.
■ 100. Section 423.1980 is amended by
revising the section heading and
paragraphs (a)(1)(iii) and (iv), (a)(2) and
(4), (d) paragraph heading, (d)(2) and
(3), (e) paragraph heading, and (e)(2)
and (3) to read as follows:
■
§ 423.1980 Reopening of coverage
determinations, redeterminations,
reconsiderations, decisions, and reviews.
(a) * * *
(1) * * *
(iii) An ALJ or attorney adjudicator to
revise his or her decision; or
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(iv) The Council to revise the ALJ or
attorney adjudicator decision, or its
review decision.
(2) When an enrollee has filed a valid
request for an appeal of a coverage
determination, redetermination,
reconsideration, ALJ or attorney
adjudicator decision, or Council review,
no adjudicator has jurisdiction to
reopen an issue that is under appeal
until all appeal rights for that issue are
exhausted. Once the appeal rights for
the issue have been exhausted, the Part
D plan sponsor, IRE, ALJ or attorney
adjudicator, or Council may reopen as
set forth in this section.
*
*
*
*
*
(4) Consistent with § 423.1978(d), the
Part D plan sponsor’s, IRE’s, ALJ’s or
attorney adjudicator’s, or Council’s
decision on whether to reopen is
binding and not subject to appeal.
*
*
*
*
*
(d) Time frame and requirements for
reopening reconsiderations, decisions
and reviews initiated by an IRE, ALJ or
attorney adjudicator, or the Council.
*
*
*
*
*
(2) An ALJ or attorney adjudicator
may reopen his or her decision, or the
Council may reopen an ALJ or attorney
adjudicator decision on its own motion
within 180 calendar days from the date
of the decision for good cause in
accordance with § 423.1986. If the
decision was procured by fraud or
similar fault, then the ALJ or attorney
adjudicator may reopen his or her
decision, or the Council may reopen an
ALJ or attorney adjudicator decision at
any time.
(3) The Council may reopen its review
decision on its own motion within 180
calendar days from the date of the
review decision for good cause in
accordance with § 423.1986. If the
Council’s decision was procured by
fraud or similar fault, then the Council
may reopen at any time.
(e) Time frames and requirements for
reopening reconsiderations, decisions,
and reviews requested by an enrollee or
a Part D plan sponsor.
*
*
*
*
*
(2) An enrollee who received an ALJ’s
or attorney adjudicator’s decision or a
Part D plan sponsor may request that an
ALJ or attorney adjudicator reopen his
or her decision, or the Council reopen
an ALJ or attorney adjudicator decision,
within 180 calendar days from the date
of the decision for good cause in
accordance with § 423.1986.
(3) An enrollee who received a
Council decision or a Part D plan
sponsor may request that the Council
reopen its decision within 180 calendar
days from the date of the review
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decision for good cause in accordance
with § 423.1986.
§ 423.1982
101. Section 423.1982 is amended
by—
■ a. Amending paragraphs (a)(1) and (2),
and (b)(1) and (2) by removing the term
‘‘ALJ’’ and adding ‘‘ALJ or attorney
adjudicator’’ in its place.
■ b. Amending paragraphs (a)(1) and (2)
and (b)(1) and (2) by removing the term
‘‘MAC’’ and adding ‘‘Council’’ in its
place.
■ 102. Section 423.1984 is amended by
revising paragraphs (d) and (e) to read
as follows:
■
§ 423.1984 Effect of a revised
determination or decision.
*
*
*
*
(d) ALJ or attorney adjudicator
decisions. The revision of an ALJ or
attorney adjudicator decision is binding
unless an enrollee submits a request for
a Council review that is accepted and
processed as specified in § 423.1974 and
§ 423.2100 through § 423.2130.
(e) Council review. The revision of a
Council determination or decision is
binding unless an enrollee files a civil
action in which a Federal District Court
accepts jurisdiction and issues a
decision.
*
*
*
*
*
■ 103. Section 423.1990 is amended
by—
■ a. Amending paragraphs (a)(2), (b)(1)
introductory text, (b)(1)(ii), and (b)(4) by
removing the term ‘‘MAC’’ each time it
appears and adding ‘‘Council’’ in its
place
■ b. Amending paragraph (d)(2)(ii) by
removing the term ‘‘MAC’s’’ and adding
‘‘Council’s’’ in its place.
■ c. Amending paragraph (b)(1)(i) by
removing the phrase ‘‘final decision’’
and adding ‘‘decision’’ in its place and
by removing the phrase ‘‘order of the
ALJ’’ and adding ‘‘order of the ALJ or an
attorney adjudicator’’ in its place.
■ d. Amending paragraph (b)(1)(ii) by
removing the term ‘‘ALJ’’ and adding
‘‘ALJ or attorney adjudicator’’ in its
place.
■ e. Amending paragraphs (c)(3), (4),
and (5) by removing the term ‘‘ALJ
hearing decision’’ and adding ‘‘ALJ or
attorney adjudicator decision’’ in its
place.
■ f. Revising paragraph (d)(1).
■ g. Amending paragraph (d)(2)(i) by
removing the term ‘‘ALJ’s’’ and adding
‘‘ALJ’s or attorney adjudicator’s’’ in its
place.
■ h. Revising paragraph (h).
The revisions read as follows:
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Expedited access to judicial
*
[Amended]
*
§ 423.1990
review.
*
*
*
*
(d) * * *
(1) Method and place for filing
request. The enrollee may—
(i) If a request for ALJ hearing or
Council review is not pending, file a
written EAJR request with the HHS
Departmental Appeals Board, with his
or her request for an ALJ hearing or
Council review; or
(ii) If an appeal is already pending for
an ALJ hearing or otherwise before
OMHA or the Council, file a written
EAJR request with the HHS
Departmental Appeals Board.
*
*
*
*
*
(h) Rejection of EAJR. (1) If a request
for EAJR does not meet all the
conditions set out in paragraphs (b), (c)
and (d) of this section, or if the review
entity does not certify a request for
EAJR, the review entity advises the
enrollee in writing that the request has
been denied, and forwards the request
to OMHA or the Council, which will
treat it as a request for hearing or for
Council review, as appropriate.
(2) Whenever a review entity forwards
a rejected EAJR request to OMHA or the
Council, the appeal is considered timely
filed and, if an adjudication time frame
applies to the appeal, the adjudication
time frame begins on the day the request
is received by OMHA or the Council
from the review entity.
■ 104. Section 423.2000 is amended by
revising the section heading and
paragraphs (a), (b), (c), (d), (e), and (g)
to read as follows:
§ 423.2000 Hearing before an ALJ and
decision by an ALJ or attorney adjudicator:
General rule.
(a) If an enrollee is dissatisfied with
an IRE’s reconsideration, the enrollee
may request a hearing before an ALJ.
(b) A hearing before an ALJ may be
conducted in-person, by videoteleconference, or by telephone. At the
hearing, the enrollee may submit
evidence subject to the restrictions in
§ 423.2018, examine the evidence used
in making the determination under
review, and present and/or question
witnesses.
(c) In some circumstances, the Part D
plan sponsor, CMS, or the IRE may
participate in the proceedings on a
request for an ALJ hearing as specified
in § 423.2010.
(d) The ALJ or attorney adjudicator
conducts a de novo review and issues a
decision based on the administrative
record, including, for an ALJ, any
hearing record.
(e) If an enrollee waives his or her
right to appear at the hearing in person
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or by telephone or video-teleconference,
the ALJ or an attorney adjudicator may
make a decision based on the evidence
that is in the file and any new evidence
that is submitted for consideration.
*
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(g) An ALJ or attorney adjudicator
may also issue a decision on the record
on his or her own initiative if the
evidence in the administrative record
supports a fully favorable finding.
§ 423.2002
[Amended]
105. Section 423.2002 is amended
by—
■ a. Amending paragraph (a)
introductory text by removing the
phrase ‘‘may request’’ and adding ‘‘has
a right to’’ in its place.
■ b. Amending paragraph (c) by
removing the phrase ‘‘The ALJ’’ and
adding ‘‘OMHA’’ in its place.
■ c. Amending paragraph (e) by
removing the word ‘‘entity’’ and adding
‘‘office’’ in its place.
■ 106. Section 423.2004 is amended by
revising the section heading and
paragraphs (a) introductory text, (a)(1)
and (4), (b), and (c) and adding
paragraph (d) to read as follows:
■
sradovich on DSK3GDR082PROD with PROPOSALS3
§ 423.2004 Right to a review of IRE notice
of dismissal.
(a) An enrollee has a right to have an
IRE’s dismissal of a request for
reconsideration reviewed by an ALJ or
attorney adjudicator if—
(1) The enrollee files a written request
for review within 60 calendar days after
receipt of the notice of the IRE’s
dismissal.
*
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*
(4) For purposes of meeting the 60
calendar day filing deadline, the request
is considered as filed on the date it is
received by the office specified in the
IRE’s dismissal.
(b) If the ALJ or attorney adjudicator
determines that the IRE’s dismissal was
in error, he or she vacates the dismissal
and remands the case to the IRE for a
reconsideration in accordance with
§ 423.2056.
(c) If the ALJ or attorney adjudicator
affirms the IRE’s dismissal of a
reconsideration request, he or she issues
a notice of decision affirming the IRE’s
dismissal in accordance with
§ 423.2046(b).
(d) The ALJ or attorney adjudicator
may dismiss the request for review of an
IRE’s dismissal in accordance with
§ 423.2052(b).
■ 107. Section 423.2008 is revised to
read as follows:
§ 423.2008 Parties to the proceedings on a
request for an ALJ hearing.
The enrollee (or the enrollee’s
representative) who filed the request for
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hearing is the only party to the
proceedings on a request for an ALJ
hearing.
■ 108. Section 423.2010 is revised to
read as follows:
§ 423.2010 When CMS, the IRE, or Part D
plan sponsors may participate in the
proceedings on a request for an ALJ
hearing.
(a) When CMS, the IRE, or the Part D
plan sponsor may participate. (1) CMS,
the IRE, and/or the Part D plan sponsor
may request to participate in the
proceedings on a request for an ALJ
hearing upon filing a request to
participate in accordance with
paragraph (b) of this section.
(2) An ALJ may request, but may not
require, CMS, the IRE, and/or the Part
D plan sponsor to participate in any
proceedings before the ALJ, including
the oral hearing, if any. The ALJ cannot
draw any adverse inferences if CMS, the
IRE, and/or the Part D plan sponsor
decide not to participate in any
proceedings before an ALJ, including
the hearing.
(b) How a request to participate is
made—(1) No notice of hearing. If CMS,
the IRE, and/or the Part D plan sponsor
requests participation before it receives
a notice of hearing, or when no notice
is required, it must send written notice
of its request to participate to the
assigned ALJ or attorney adjudicator, or
a designee of the Chief ALJ if the request
is not yet assigned to an ALJ or attorney
adjudicator, and the enrollee, except
that the request may be made orally if
a request for an expedited hearing was
filed and OMHA will notify the enrollee
of the request to participate.
(2) Notice of hearing. If CMS, the IRE,
and/or the Part D plan sponsor requests
participation after the IRE and Part D
plan sponsor receive a notice of hearing,
it must send written notice of its request
to participate to the ALJ and the
enrollee, except that the request to
participate may be made orally for an
expedited hearing and OMHA will
notify the enrollee of the request to
participate.
(3) Timing of request. CMS, the IRE,
and/or the Part D plan sponsor must
send its request to participate—
(i) If a standard request for hearing
was filed, if no hearing is scheduled,
within 30 calendar days after
notification that a standard request for
hearing was filed;
(ii) If an expedited hearing is
requested, but no hearing has been
scheduled, within 2 calendar days after
notification that a request for an
expedited hearing was filed.
(iii) If a non-expedited hearing is
scheduled, within 5 calendar days after
receiving the notice of hearing; or
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(iv) If an expedited hearing is
scheduled, within 1 calendar day after
receiving the notice of hearing. Requests
may be made orally or submitted by
facsimile to the hearing office.
(c) The ALJ’s or attorney adjudicator’s
decision on a request to participate. The
assigned ALJ or attorney adjudicator has
discretion not to allow CMS, the IRE,
and/or the Part D plan sponsor to
participate. The ALJ or attorney
adjudicator must notify the entity
requesting participation, the Part D plan
sponsor, if applicable, and the enrollee
of his or her decision on the request to
participate within the following time
frames—
(1) If no hearing is scheduled, at least
20 calendar days before the ALJ or
attorney adjudicator issues a decision,
dismissal, or remand;
(2) If a non-expedited hearing is
scheduled, within 5 calendar days of
receipt of a request to participate; or
(3) If an expedited hearing is
scheduled, within 1 calendar of receipt
of a request to participate.
(d) Roles and responsibilities of CMS,
the IRE, and/or the Part D plan sponsor
as a participant. (1) Participation may
include filing position papers and/or
providing testimony to clarify factual or
policy issues in a case, but it does not
include calling witnesses or crossexamining the witnesses of an enrollee
to the hearing.
(2) When CMS, the IRE, and/or the
Part D plan sponsor participates in an
ALJ hearing, CMS, the IRE, and/or the
Part D plan sponsor may not be called
as a witness during the hearing and is
not subject to examination or crossexamination by the enrollee, but the
enrollee may provide testimony to rebut
factual or policy statements made by a
participant and the ALJ may question
the participant about its testimony.
(3) CMS, IRE, and/or Part D plan
sponsor positon papers and written
testimony are subject to the following:
(i) Unless the ALJ or attorney
adjudicator grants additional time to
submit a position paper or written
testimony, a position paper and written
testimony must be submitted—
(A) Within 14 calendar days for a
standard appeal, or 1 calendar day for
an expedited appeal, after receipt of the
ALJ’s or attorney adjudicator’s decision
on a request to participate if no hearing
has been scheduled; or
(B) No later than 5 calendar days prior
to the hearing if a non-expedited
hearing is scheduled, or 1 calendar day
prior to the hearing if an expedited
hearing is scheduled.
(ii) A copy of any position paper and
written testimony that CMS, the IRE, or
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the Part D plan sponsor submits to
OMHA must be sent to the enrollee.
(iii) If CMS, the IRE, and/or the Part
D plan sponsor fails to send a copy of
its position paper or written testimony
to the enrollee or fails to submit its
position paper or written testimony
within the time frames described in this
section, the position paper or written
testimony will not be considered in
deciding the appeal.
(e) Invalid requests to participate. (1)
An ALJ or attorney adjudicator may
determine that a CMS, IRE, and/or Part
D plan sponsor request to participate is
invalid under this section if the request
to participate was not timely filed or the
request to participate was not sent to the
enrollee.
(2) If the request to participate is
determined to be invalid, the written
notice of an invalid request to
participate must be sent to the entity
that made the request to participate and
the enrollee.
(i) If no hearing is scheduled or the
request to participate was made after the
hearing occurred, the written notice of
an invalid request to participate must be
sent no later than the date the notice of
decision, dismissal, or remand is
mailed.
(ii) If a non-expedited hearing is
scheduled, the written notice of an
invalid request to participate must be
sent prior to the hearing. If the notice
would be sent fewer than 5 calendar
days before the hearing is scheduled to
occur, oral notice must be provided to
the entity that submitted the request,
and the written notice must be sent as
soon as possible after the oral notice is
provided.
(iii) If an expedited hearing is
scheduled, oral notice of an invalid
request to participate must be provided
to the entity that submitted the request,
and the written notice must be sent as
soon as possible after the oral notice is
provided.
■ 109. Section 423.2014 is revised to
read as follows:
sradovich on DSK3GDR082PROD with PROPOSALS3
§ 423.2014 Request for an ALJ hearing or
a review of an IRE dismissal.
(a) Content of the request. (1) The
request for an ALJ hearing or a review
of an IRE dismissal must be made in
writing, except as set forth in paragraph
(b) of this section. The request,
including any oral request, must include
all of the following—
(i) The name, address, telephone
number, and Medicare health insurance
claim number of the enrollee.
(ii) The name, address, and telephone
number of the appointed representative,
as defined at § 423.560, if any.
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(iii) The Medicare appeal number, if
any, assigned to the IRE reconsideration
or dismissal being appealed.
(iv) The prescription drug in dispute.
(v) The plan name.
(vi) The reasons the enrollee disagrees
with the IRE’s reconsideration or
dismissal being appealed.
(vii) A statement of whether the
enrollee is aware that he or she, or the
prescription for the drug being
appealed, is the subject of an
investigation or proceeding by the HHS
Office of Inspector General or other law
enforcement agencies.
(2) The enrollee must submit a
statement of any additional evidence to
be submitted and the date it will be
submitted.
(3) The enrollee must submit a
statement that the enrollee is requesting
an expedited hearing, if applicable.
(b) Request for expedited hearing. If
an enrollee is requesting that the
hearing be expedited, the enrollee may
make the request for an ALJ hearing
orally, but only after receipt of the
written IRE reconsideration notice.
OMHA must document all oral requests
in writing and maintain the
documentation in the case files. A
prescribing physician or other
prescriber may provide oral or written
support for an enrollee’s request for
expedited review.
(c) Complete request required. (1) A
request must contain the information in
paragraph (a)(1) of this section to the
extent the information is applicable, to
be considered complete. If a request is
not complete, the enrollee will be
provided with an opportunity to
complete the request, and if an
adjudication time frame applies it does
not begin until the request is complete.
If the enrollee fails to provide the
information necessary to complete the
request within the time frame provided,
the enrollee’s request for hearing or
review will be dismissed.
(2) If supporting materials submitted
with a request clearly provide
information required for a complete
request, the materials will be considered
in determining whether the request is
complete.
(d) When and where to file. Consistent
with §§ 423.1972(a) and (b), the request
for an ALJ hearing after an IRE
reconsideration or request for review of
an IRE dismissal must be filed:
(1) Within 60 calendar days from the
date the enrollee receives written notice
of the IRE’s reconsideration or dismissal
being appealed.
(2) With the office specified in the
IRE’s reconsideration or dismissal.
(i) If the request for hearing is timely
filed with an office other than the office
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specified in the IRE’s reconsideration,
any applicable time frame specified in
§ 423.2016 for deciding the appeal
begins on the date the office specified in
the IRE’s reconsideration or dismissal
receives the request for hearing.
(ii) If the request for hearing is filed
with an office, other than the office
specified in the IRE’s reconsideration or
dismissal, OMHA must notify the
enrollee of the date the request was
received in the correct office and the
commencement of any applicable
adjudication timeframe.
(e) Extension of time to request a
hearing or review. (1) Consistent with
§ 423.1972(b), if the request for hearing
or review is not filed within 60 calendar
days of receipt of the written IRE’s
reconsideration or dismissal, an enrollee
may request an extension for good
cause.
(2) Any request for an extension of
time must be in writing or, for expedited
reviews, in writing or oral. OMHA must
document all oral requests in writing
and maintain the documentation in the
case file.
(3) The request must give the reasons
why the request for a hearing or review
was not filed within the stated time
period, and must be filed with the
request for hearing or review of an IRE
dismissal with the office specified in the
notice of reconsideration or dismissal.
(4) An ALJ or attorney adjudicator
may find there is good cause for missing
the deadline to file a request for an ALJ
hearing or request for review of an IRE
dismissal, or there is no good cause for
missing the deadline to file a request for
a review of an IRE dismissal, but only
an ALJ may find there is no good cause
for missing the deadline to file a request
for an ALJ hearing. If good cause is
found for missing the deadline, the time
period for filing the request for hearing
or request for review of an IRE dismissal
will be extended. To determine whether
good cause for late filing exists, the ALJ
or attorney adjudicator uses the
standards set forth in § 405.942(b)(2)
and (3) of this chapter.
(5) If a request for hearing is not
timely filed, any applicable adjudication
period in § 423.2016 begins the date the
ALJ or attorney adjudicator grants the
request to extend the filing deadline.
(6) A determination granting a request
to extend the filing deadline is not
subject to further review.
■ 110. Section 423.2016 is revised to
read as follows:
§ 423.2016 Timeframes for deciding an
appeal of an IRE reconsideration.
(a) Standard appeals. (1) When a
request for an ALJ hearing is filed after
an IRE has issued a written
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reconsideration, an ALJ or attorney
adjudicator issues a decision, dismissal
order, or remand, as appropriate, no
later than the end of the 90 calendar day
period beginning on the date the request
for hearing is received by the office
specified in the IRE’s notice of
reconsideration, unless the 90 calendar
day period has been extended as
provided in this subpart.
(2) The adjudication period specified
in paragraph (a)(1) of this section begins
on the date that a timely filed request
for hearing is received by the office
specified in the IRE’s reconsideration,
or, if it is not timely filed, the date that
the ALJ or attorney adjudicator grants
any extension to the filing deadline.
(3) If the Council remands a case and
the case was subject to an adjudication
time frame under paragraph (a)(1) of this
section, the remanded appeal will be
subject to the same adjudication time
frame beginning on the date that OMHA
receives the Council remand.
(b) Expedited appeals—(1) Standard
for expedited appeal. An ALJ or
attorney adjudicator issues an expedited
decision if the appeal involves an issue
specified in § 423.566(b), but is not
solely a request for payment of Part D
drugs already furnished, and the
enrollee’s prescribing physician or other
prescriber indicates, or an ALJ or
attorney adjudicator determines that
applying the standard timeframe for
making a decision may seriously
jeopardize the enrollee’s life, health or
ability to regain maximum function. An
ALJ or attorney adjudicator may
consider this standard as met if a lower
level adjudicator has granted a request
for an expedited hearing.
(2) Grant of a request. If an ALJ or
attorney adjudicator grants a request for
expedited hearing, an ALJ or attorney
adjudicator must—
(i) Make the decision to grant an
expedited appeal within 5 calendar days
of receipt of the request for an expedited
hearing;
(ii) Give the enrollee prompt oral
notice of this decision; and
(iii) Subsequently send to the enrollee
at his or her last known address and to
the Part D plan sponsor written notice
of the decision. This notice may be
provided within the written notice of
hearing.
(3) Denial of a request. If an ALJ or
attorney adjudicator denies a request for
expedited hearing, an ALJ or attorney
adjudicator must—
(i) Make this decision within 5
calendar days of receipt of the request
for expedited hearing;
(ii) Give the enrollee prompt oral
notice of the denial that informs the
enrollee of the denial and explains that
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an ALJ or attorney adjudicator will
process the enrollee’s request using the
90 calendar day timeframe for nonexpedited appeals; and
(iii) Subsequently send to the enrollee
at his or her last known address and to
the Part D plan sponsor an equivalent
written notice of the decision within 3
calendar days after the oral notice.
(4) Decision not appealable. A
decision on a request for expedited
hearing may not be appealed.
(5) Time frame for adjudication. (i) If
an ALJ or attorney adjudicator accepts a
request for expedited hearing, an ALJ or
attorney adjudicator issues a written
decision, dismissal order, or remand as
expeditiously as the enrollee’s health
condition requires, but no later than the
end of the 10 calendar day period
beginning on the date the request for
hearing is received by the office
specified in the IRE’s written notice of
reconsideration, unless the 10 calendar
day period has been extended as
provided in this subpart.
(ii) The adjudication period specified
in paragraph (b)(5)(i) of this section
begins on the date that a timely
provided request for hearing is received
by the office specified in the IRE’s
reconsideration, or, if it is not timely
provided, the date that an ALJ or
attorney adjudicator grants any
extension to the filing deadline.
(6) Time frame for Council remands.
If the Council remands a case and the
case was subject to an adjudication time
frame under paragraph (b)(5) of this
section, the remanded appeal will be
subject to the same adjudication
timeframe beginning on the date that
OMHA receives the Council remand, if
the standards for an expedited appeal
continue to be met. If the standards for
an expedited appeal are no longer met,
the appeal will be subject to the
adjudication time frame for a standard
appeal.
(c) Waivers and extensions of
adjudication period. (1) At any time
during the adjudication process, the
enrollee may waive the adjudication
period specified in paragraphs (a)(1) and
(b)(5) of this section. The waiver may be
for a specific period of time agreed upon
by the ALJ or attorney adjudicator and
the enrollee.
(2) The adjudication periods specified
in paragraphs (a)(1) and (b)(5) of this
section are extended as otherwise
specified in this subpart, and for the
following events—
(i) The duration of a stay of action on
adjudicating the matters at issue ordered
by a court or tribunal of competent
jurisdiction;
(ii) The duration of a stay of
proceedings granted by an ALJ or
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43881
attorney adjudicator on a motion by an
enrollee.
■ 111. Section 423.2018 is revised to
read as follows:
§ 423.2018
Submitting evidence.
(a) All appeals. An enrollee must
submit any written or other evidence
that he or she wishes to have
considered.
(1) An ALJ or attorney adjudicator
will not consider any evidence
submitted regarding a change in
condition of an enrollee after the
appealed coverage determination was
made.
(2) An ALJ or attorney adjudicator
will remand a case to the Part D IRE
where an enrollee wishes evidence on
his or her change in condition after the
coverage determination to be
considered.
(b) Non-expedited appeals. (1) Except
as provided in this paragraph, a
represented enrollee must submit all
written or other evidence he or she
wishes to have considered with the
request for hearing by the date specified
in the request for hearing in accordance
with § 423.2014(a)(2), or, if a hearing is
scheduled, within 10 calendar days of
receiving the notice of hearing.
(2) If a represented enrollee submits
written or other evidence later than 10
calendar days after receiving the notice
of hearing, any applicable adjudication
period specified in § 423.2016 is
extended by the number of calendar
days in the period between 10 calendar
days after receipt of the notice of
hearing and the day the evidence is
received.
(3) The requirements of paragraph (b)
of this section do not apply to
unrepresented enrollees.
(c) Expedited appeals. (1) Except as
provided in this section, an enrollee
must submit all written or other
evidence he or she wishes to have
considered with the request for hearing
by the date specified in the request for
hearing pursuant to § 423.2014(a)(2), or,
if an expedited hearing is scheduled,
within 2 calendar days of receiving the
notice of the expedited hearing.
(2) If an enrollee submits written or
other evidence later than 2 calendar
days after receiving the notice of
expedited hearing, any applicable
adjudication period specified in
§ 423.2016 is extended by the number of
calendar days in the period between 2
calendar days after receipt of the notice
of expedited hearing and the day the
evidence is received.
(d) When this section does not apply.
The requirements of paragraphs (b) and
(c) of this section do not apply to oral
testimony given at a hearing.
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112. Section 423.2020 is amended by
a. Revising paragraphs (b), (c), (d), and
(e)(3) and (4).
■ b. Adding paragraphs (g)(3)(vii) and
(viii).
■ c. Revising paragraphs (h), (i)
paragraph heading, and (i)(1), (2), (4),
and (5).
■ d. Adding paragraph (j).
The revisions and additions read as
follows:
■
■
§ 423.2020 Time and place for a hearing
before an ALJ.
sradovich on DSK3GDR082PROD with PROPOSALS3
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(b) Determining how appearances are
made. (1) Appearances by
unrepresented enrollees. The ALJ will
direct that the appearance of an
unrepresented enrollee who filed a
request for hearing be conducted by
video-teleconferencing if the ALJ finds
that video-teleconferencing technology
is available to conduct the appearance,
unless the ALJ finds good cause for an
in-person appearance.
(i) The ALJ may also offer to conduct
a hearing by telephone if the request for
hearing or administrative record
suggests that a telephone hearing may
be more convenient for the
unrepresented enrollee.
(ii) The ALJ, with the concurrence of
the Chief ALJ or designee, may find
good cause that an in-person hearing
should be conducted if—
(A) The video-teleconferencing or
telephone technology is not available; or
(B) Special or extraordinary
circumstances exist.
(2) Appearances by represented
enrollees. The ALJ will direct that the
appearance of an individual, other than
an unrepresented enrollee who filed a
request for hearing, be conducted by
telephone, unless the ALJ finds good
cause for an appearance by other means.
(i) The ALJ may find good cause for
an appearance by videoteleconferencing if he or she determines
that video-teleconferencing is necessary
to examine the facts or issues involved
in the appeal.
(ii) The ALJ, with the concurrence of
the Chief ALJ or designee, may find
good cause that an in-person hearing
should be conducted if—
(A) The video-teleconferencing or
telephone technology is not available; or
(B) Special or extraordinary
circumstances exist.
(c) Notice of hearing. (1) A notice of
hearing is sent to the enrollee, the Part
D plan sponsor that issued the coverage
determination, and the IRE that issued
the reconsideration, advising them of
the proposed time and place of the
hearing.
(2) The notice of hearing will require
the enrollee to reply to the notice by:
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(i) Acknowledging whether they plan
to attend the hearing at the time and
place proposed in the notice of hearing,
or whether they object to the proposed
time and/or place of the hearing;
(ii) If the representative is an entity or
organization, specifying who from the
entity or organization plans to attend
the hearing, if anyone, and in what
capacity, in addition to the individual
who filed the request for hearing; and
(iii) Listing the witnesses who will be
providing testimony at the hearing.
(3) The notice of hearing will require
CMS, the IRE, or the Part D plan sponsor
that requests to attend the hearing as a
participant to reply to the notice by:
(i) Acknowledging whether it plans to
attend the hearing at the time and place
proposed in the notice of hearing; and
(ii) Specifying who from the entity
plans to attend the hearing,
(d) An enrollee’s right to waive a
hearing. An enrollee may also waive the
right to a hearing and request a decision
based on the written evidence in the
record in accordance with § 423.2038(b).
(1) As specified in § 423.2000, an ALJ
may require the enrollee to attend a
hearing if it is necessary to decide the
case.
(2) If an ALJ determines that it is
necessary to obtain testimony from a
person other than the enrollee, he or she
may still hold a hearing to obtain that
testimony, even if the enrollee has
waived the right to appear. In those
cases, the ALJ would give the enrollee
the opportunity to appear when the
testimony is given but may hold the
hearing even if the enrollee decides not
to appear.
*
*
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*
(e) * * *
(3) The objection must be in writing
except for an expedited hearing when
the objection may be provided orally,
and except that the enrollee may orally
request that a non-expedited hearing be
rescheduled in an emergency
circumstance the day prior to or day of
the hearing. The ALJ must document all
oral objections to the time and place of
a hearing in writing and maintain the
documentation in the case files.
(4) The ALJ may change the time or
place of the hearing if the enrollee has
good cause.
*
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*
(g) * * *
(3) * * *
(vii) The enrollee or enrollee’s
representative has a prior commitment
that cannot be changed without
significant expense.
(viii) The enrollee or enrollee’s
representative asserts he or she did not
receive the notice of hearing and is
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unable to appear at the scheduled time
and place.
(h) Effect of rescheduling hearing. If a
hearing is postponed at the request of
the enrollee for any of the above
reasons, the time between the originally
scheduled hearing date and the new
hearing date is not counted toward the
adjudication period specified in
§ 423.2016.
(i) An enrollee’s request for an inperson or video-teleconferencing
hearing. (1) If an unrepresented enrollee
objects to a video-teleconferencing
hearing or to the ALJ’s offer to conduct
a hearing by telephone, or a represented
enrollee who filed the request for
hearing objects to a telephone or videoteleconferencing hearing, the enrollee or
the enrollee’s representative must notify
the ALJ at the earliest possible
opportunity before the time set for the
hearing and request a videoteleconferencing or an in-person
hearing.
(2) The enrollee must state the reason
for the objection and state the time and/
or place he or she wants an in-person or
video-teleconferencing hearing to be
held.
*
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*
*
(4) When an enrollee’s request for an
in-person or video-teleconferencing
hearing is granted and an adjudication
time frame applies in accordance with
§ 423.2016, the ALJ issues a decision,
dismissal, or remand to the IRE within
the adjudication time frame specified in
§ 423.2016 (including any applicable
extensions provided in this subpart),
unless the enrollee requesting the
hearing agrees to waive such
adjudication timeframe in writing.
(5) The ALJ may grant the request,
with the concurrence of the Chief ALJ
or designee, upon a finding of good
cause and will reschedule the hearing
for a time and place when the enrollee
may appear in person or by videoteleconference before the ALJ.
(j) Amended notice of hearing. If the
ALJ changes or will change the time
and/or place of the hearing, an amended
notice of hearing must be sent to the
enrollee and CMS, the IRE, and/or the
Part D plan sponsor in accordance with
§ 423.2022(a)(2).
■ 113. Section 423.2022 is revised to
read as follows:
§ 423.2022
ALJ.
Notice of a hearing before an
(a) Issuing the notice. (1) After the ALJ
sets the time and place of the hearing,
the notice of the hearing will be mailed
or otherwise transmitted in accordance
with OMHA procedures to the enrollee
and other potential participants, as
provided in § 423.2020(c) at their last
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known addresses, or given by personal
service, except to an enrollee or other
potential participant who indicates in
writing that he or she does not wish to
receive this notice.
(2) The notice is mailed, transmitted,
or served at least 20 calendar days
before the hearing, except for expedited
hearings where written notice is mailed,
transmitted, or served at least 3 calendar
days before the hearing, unless the
enrollee or other potential participant
agrees in writing to the notice being
mailed, transmitted, or served fewer
than 20 calendar days before the nonexpedited hearing or 3 calendar days
before the expedited hearing. For
expedited hearings, the ALJ may orally
provide notice of the hearing to the
enrollee and other potential participants
but oral notice must be followed by an
equivalent written notice within 1
calendar day of the oral notice.
(b) Notice information. (1) The notice
of hearing contains—
(i) A statement that the issues before
the ALJ include all of the issues brought
out in the coverage determination,
redetermination, or reconsideration that
were not decided entirely in the
enrollee’s favor and that were specified
in the request for hearing; and
(ii) A statement of any specific new
issues the ALJ will consider in
accordance with § 423.2032.
(2) The notice will inform the enrollee
that he or she may designate a person
to represent him or her during the
proceedings.
(3) The notice must include an
explanation of the procedures for
requesting a change in the time or place
of the hearing, a reminder that the ALJ
may dismiss the hearing request if the
enrollee fails to appear at the scheduled
hearing without good cause, and other
information about the scheduling and
conduct of the hearing.
(4) The enrollee will also be told if his
or her appearance or that of any other
witness is scheduled by videoteleconferencing, telephone, or in
person. If the ALJ has scheduled the
enrollee to appear at the hearing by
video-teleconferencing, the notice of
hearing will advise that the scheduled
place for the hearing is a videoteleconferencing site and explain what
it means to appear at the hearing by
video-teleconferencing.
(5) The notice advises the enrollee
that if he or she objects to appearing by
video-teleconferencing or telephone,
and wishes instead to have his or her
hearing at a time and place where he or
she may appear in person before the
ALJ, he or she must follow the
procedures set forth at § 423.2020(i) for
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notifying the ALJ of his or her objections
and for requesting an in-person hearing.
(c) Acknowledging the notice of
hearing. (1) If the enrollee or his or her
representative does not acknowledge
receipt of the notice of hearing, OMHA
attempts to contact the enrollee for an
explanation.
(2) If the enrollee states that he or she
did not receive the notice of hearing, a
copy of the notice is sent to him or her
by certified mail or other means
requested by the enrollee and in
accordance with OMHA procedures.
(3) The enrollee may request that the
ALJ reschedule the hearing in
accordance with § 423.2020(e).
■ 114. Section 423.2024 is amended
by—
■ a. Amending paragraph (a) by
removing the phrase ‘‘The ALJ hearing
office’’ and adding ‘‘OMHA’’ in its
place.
■ b. Revising paragraph (c) to read as
follows:
§ 423.2024
Objections to the issues.
*
*
*
*
*
(c) The ALJ makes a decision on the
objections either in writing, at a
prehearing conference, or at the hearing.
■ 115. Section 423.2026 is revised to
read as follows:
§ 423.2026 Disqualification of the ALJ or
attorney adjudicator.
(a) An ALJ or attorney adjudicator
may not adjudicate an appeal if he or
she is prejudiced or partial to the
enrollee or has any interest in the matter
pending for decision.
(b) If an enrollee objects to the ALJ or
attorney adjudicator assigned to
adjudicate the appeal, the enrollee must
notify the ALJ within 10 calendar days
of the date of the notice of hearing if a
non-expedited hearing is scheduled,
except for expedited hearings in which
the enrollee must submit written or oral
notice no later than 2 calendar days
after the date of the notice of hearing, or
the ALJ or attorney adjudicator at any
time before a decision, dismissal order,
or remand order is issued if no hearing
is scheduled. The ALJ or attorney
adjudicator must document all oral
objections in writing and maintain the
documentation in the case files. The ALJ
or attorney adjudicator considers the
enrollee’s objections and decides
whether to proceed with the appeal or
withdraw.
(c) If the ALJ or attorney adjudicator
withdraws, another ALJ or attorney
adjudicator will be assigned to
adjudicate the appeal. If the ALJ or
attorney adjudicator does not withdraw,
the enrollee may, after the ALJ or
attorney adjudicator has issued an
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action in the case, present his or her
objections to the Council in accordance
with § 423.2100 through § 423.2130. The
Council will then consider whether the
decision or dismissal should be revised
or, if applicable, a new hearing held
before another ALJ.
(d) If the enrollee objects to the ALJ
or attorney adjudicator and the ALJ or
attorney adjudicator subsequently
withdraws from the appeal, any
adjudication period that applies to the
appeal in accordance with § 423.2016 is
extended by 14 calendar days for a
standard appeal, or 2 calendar days for
an expedited appeal.
■ 116. Section 423.2030 is revised to
read as follows:
§ 423.2030
ALJ hearing procedures.
(a) General rule. A hearing is open to
the enrollee and to other persons the
ALJ considers necessary and proper.
(b) At the hearing. (1) The ALJ fully
examines the issues, questions the
enrollee and other witnesses, and may
accept evidence that is material to the
issues consistent with § 423.2018.
(2) The ALJ may limit testimony and
argument at the hearing that are not
relevant to an issue before the ALJ, or
that address an issue before the ALJ for
which the ALJ determines he or she has
sufficient information or on which the
ALJ has already ruled. The ALJ may, but
is not required to, provide the enrollee
or representative with an opportunity to
submit additional written statements
and affidavits on the matter in lieu of
testimony and/or argument at the
hearing. The written statements and
affidavits must be submitted within the
time frame designated by the ALJ.
(3) If the ALJ determines that the
enrollee or enrollee’s representative is
uncooperative, disruptive to the
hearing, or abusive during the course of
the hearing, the ALJ may excuse the
enrollee or representative from the
hearing and continue with the hearing
to provide the participants with an
opportunity to offer testimony and/or
argument. If an enrollee or
representative was excused from the
hearing, the ALJ will provide the
enrollee or representative with an
opportunity to submit written
statements and affidavits in lieu of
testimony and/or argument at the
hearing, and the enrollee or
representative may request a recording
of the hearing in accordance with
§ 423.2042 and respond in writing to
any statements made by participants
and/or testimony of the witnesses at the
hearing. The written statements and
affidavits must be submitted within the
time frame designated by the ALJ.
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(c) Missing evidence. The ALJ may
also stop the hearing temporarily and
continue it at a later date if he or she
believes that there is material evidence
missing at the hearing.
(d) Effect of new evidence on
adjudication period. If an enrollee, other
than an unrepresented enrollee in a
standard appeal, submits evidence
pursuant to paragraph (b) or (c), and an
adjudication period applies to the
appeal, the adjudication period
specified in § 423.2016 is extended in
accordance with § 423.2018(b) or (c), as
applicable.
(e) Continued hearing. (1) A hearing
may be continued to a later date. Notice
of the continued hearing must be sent in
accordance with § 423.2022, except that
a waiver of notice of the hearing may be
made in writing or on the record, and
the notice is sent to the enrollee and
participants who attended the hearing,
and any additional potential
participants the ALJ determines are
appropriate.
(2) If the enrollee requests the
continuance and an adjudication time
frame applies to the appeal in
accordance with § 423.2016, the
adjudication period is extended by the
period between the initial hearing date
and the continued hearing date.
(f) Supplemental hearing. (1) The ALJ
may conduct a supplemental hearing at
any time before he or she mails a notice
of the decision in order to receive new
and material evidence, obtain additional
testimony, or address a procedural
matter. The ALJ determines whether a
supplemental hearing is necessary and
if one is held, the scope of the hearing,
including when evidence is presented
and what issues are discussed. Notice of
the supplemental hearing must be sent
in accordance with § 423.2022, except
that the notice is sent to the enrollee
and participants who attended the
hearing, and any additional potential
participants the ALJ determines are
appropriate.
(2) If the enrollee requests the
supplemental hearing and an
adjudication period applies to the
appeal in accordance with § 423.2016,
the adjudication period is extended by
the period between the initial hearing
date and the supplemental hearing date.
■ 117. Section 423.2032 is revised to
read as follows:
§ 423.2032 Issues before an ALJ or
attorney adjudicator.
(a) General rule. The issues before the
ALJ or attorney adjudicator include all
the issues for the appealed matter
specified in the request for hearing that
were brought out in the coverage
determination, redetermination, or
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reconsideration that were not decided
entirely in an enrollee’s favor.
(b) New issues—(1) When a new issue
may be considered. A new issue may
include issues resulting from the
participation of CMS, the IRE, or the
Part D plan sponsor at the OMHA level
of adjudication and from any evidence
and position papers submitted by CMS,
the IRE, or the Part D plan sponsor for
the first time to the ALJ. The ALJ or the
enrollee may raise a new issue;
however, the ALJ may only consider a
new issue relating to a determination or
appealed matter specified in the request
for hearing, including a favorable
portion of a determination or appealed
matter specified in the request for
hearing, if its resolution could have a
material impact on the appealed matter
and—
(i) There is new and material evidence
that was not available or known at the
time of the determination and that may
result in a different conclusion; or
(ii) The evidence that was considered
in making the determination clearly
shows on its face that an obvious error
was made at the time of the
determination.
(2) Notice of the new issue. The ALJ
may consider a new issue at the hearing
if he or she notifies the enrollee about
the new issue before the start of the
hearing.
(3) Opportunity to submit evidence. If
notice of the new issue is sent after the
notice of hearing, the enrollee will have
at least 10 calendar days in standard
appeals or 2 calendar days in expedited
appeals after receiving notice of the new
issue to submit evidence regarding the
issue, and without affecting any
applicable adjudication period. If a
hearing is conducted before the time to
submit evidence regarding the issue
expires, the record will remain open
until the opportunity to submit
evidence expires.
(c) Adding coverage determinations to
a pending appeal. A coverage
determination on a drug that was not
specified in a request for hearing may
only be added to pending appeal if the
coverage determination was adjudicated
in the same reconsideration that is
appealed, and the period to request an
ALJ hearing for that reconsideration has
not expired, or an ALJ or attorney
adjudicator extends the time to request
an ALJ hearing on the reconsideration in
accordance with § 423.2014(e).
■ 118. Section 423.2034 is revised to
read as follows:
§ 423.2034
the IRE.
Requesting information from
(a) If an ALJ or attorney adjudicator
believes that the written record is
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missing information that is essential to
resolving the issues on appeal and that
information can be provided only by
CMS, the IRE, and/or the Part D plan
sponsor, the information may be
requested from the IRE that conducted
the reconsideration or its successor.
(1) Official copies of redeterminations
and reconsiderations that were
conducted on the appealed issues can
only be provided by CMS, the IRE, and/
or the Part D plan sponsor.
(2) ‘‘Can be provided only by CMS,
the IRE, and/or the Part D plan sponsor’’
means the information is not publicly
available, is not in the possession of the
enrollee, and cannot be requested and
obtained by the enrollee. Information
that is publicly available is information
that is available to the general public via
the Internet or in a printed publication.
Information that is publicly available
includes, but is not limited to,
information available on a CMS, IRE or
Part D Plan sponsor Web site or
information in an official CMS or HHS
publication.
(b) The ALJ or attorney adjudicator
retains jurisdiction of the case, and the
case remains pending at OMHA.
(c) The IRE has 15 calendar days for
standard appeals, or 2 calendar days for
expedited appeals, after receiving the
request for information to furnish the
information or otherwise respond to the
information request directly or through
CMS or the Part D plan sponsor.
(d) If an adjudication period applies
to the appeal in accordance with
§ 423.2016, the adjudication period is
extended by the period between the date
of the request for information and the
date the IRE responds to the request or
20 calendar days after the date of the
request for standard appeals, or 3
calendar days after the date of the
request for expedited appeals,
whichever occurs first.
§ 423.2036
[Amended]
119. Section 423.2036 is amended
by—
■ a. Amending paragraph (b)(1)
introductory text by removing the
phrase ‘‘send the ALJ’’ and adding
‘‘submit to OMHA’’ in its place.
■ b. Amending paragraph (b)(1)(ii) by
removing the phrase ‘‘The ALJ hearing
office’’ and adding ‘‘OMHA’’ in its
place.
■ c. Removing paragraph (d).
■ d. Redesignating paragraph (g) as new
paragraph (d).
■ e. Amending paragraphs (f)(2), (f)(3)
introductory text, and (f)(3) (i), (ii), and
(iii) by removing the term ‘‘MAC’’ and
adding ‘‘Council’’ in its place.
■
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f. Amending paragraph (f)(2) by
removing the term ‘‘MAC’s’’ and adding
‘‘Council’s’’ in its place.
■ 120. Section 423.2038 is revised to
read as follows:
■
§ 423.2038 Deciding a case without a
hearing before an ALJ.
(a) Decision fully favorable. If the
evidence in the administrative record
supports a finding fully in favor of the
enrollee(s) on every issue, the ALJ or
attorney adjudicator may issue a
decision without giving the enrollee(s)
prior notice and without an ALJ
conducting a hearing. The notice of the
decision informs the enrollee(s) that he
or she has the right to a hearing and a
right to examine the evidence on which
the decision is based.
(b) Enrollee does not wish to appear.
(1) The ALJ or attorney adjudicator may
decide a case on the record and without
an ALJ conducting a hearing if—
(i) The enrollee indicates in writing
or, for expedited hearings orally or in
writing, that he or she does not wish to
appear before an ALJ at a hearing,
including a hearing conducted by
telephone or video-teleconferencing, if
available. OMHA must document all
oral requests not to appear at a hearing
in writing and maintain the
documentation in the case files; or
(ii) The enrollee lives outside the
United States and does not inform
OMHA that he or she wants to appear
at a hearing before an ALJ.
(2) When a hearing is not held, the
decision of the ALJ or attorney
adjudicator must refer to the evidence in
the record on which the decision was
based.
(c) Stipulated decision. If CMS, the
IRE, and/or the Part D plan sponsor
submits a written statement or makes an
oral statement at a hearing indicating
the drug should be covered or payment
may be made, an ALJ or attorney
adjudicator may issue a stipulated
decision finding in favor of the enrollee
on the basis of the statement, and
without making findings of fact,
conclusions of law, or further
explaining the reasons for the decision.
■ 121. Section 423.2040 is revised to
read as follows:
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§ 423.2040 Prehearing and posthearing
conferences.
(a) The ALJ may decide on his or her
own, or at the request of the enrollee to
the hearing, to hold a prehearing or
posthearing conference to facilitate the
hearing or the hearing decision.
(b) For non-expedited hearings, the
ALJ informs the enrollee, and CMS, the
IRE, and/or the Part D plan sponsor if
the ALJ has granted their request(s) to be
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a participant to the hearing at the time
the notice of conference is sent, of the
time, place, and purpose of the
conference at least 7 calendar days
before the conference date, unless the
enrollee indicates in writing that he or
she does not wish to receive a written
notice of the conference.
(c) For expedited hearings, the ALJ
informs the enrollee, and CMS, the IRE,
and/or the Part D plan sponsor if the
ALJ has granted their request(s) to be a
participant to the hearing, of the time,
place, and purpose of the conference at
least 2 calendar days before the
conference date, unless the enrollee
indicates orally or in writing that he or
she does not wish to receive a written
notice of the conference.
(d) All oral requests not to receive
written notice of the conference must be
documented in writing and the
documentation must be made part of the
administrative record.
(e) At the conference—
(1) The ALJ or an OMHA attorney
designated by the ALJ conducts the
conference, but only the ALJ conducting
a conference may consider matters in
addition to those stated in the
conference notice, if the enrollee
consents to consideration of the
additional matters in writing.
(2) An audio recording of the
conference is made.
(f) The ALJ issues an order to the
enrollee and all participants who
attended the conference stating all
agreements and actions resulting from
the conference. If the enrollee does not
object within 10 calendar days of
receiving the order for non-expedited
hearings or 1 calendar day for expedited
hearings, or any additional time granted
by the ALJ, the agreements and actions
become part of the administrative record
and are binding on the enrollee.
■ 122. Section 423.2042 is revised to
read as follows:
§ 423.2042
The administrative record.
(a) Creating the record. (1) OMHA
makes a complete record of the evidence
and administrative proceedings on the
appealed matter, including any
prehearing and posthearing conference
and hearing proceedings that were
conducted.
(2) The record will include marked as
exhibits, the appealed determinations
and documents and other evidence used
in making the appealed determinations
and the ALJ’s or attorney adjudicator’s
decision, including, but not limited to,
medical records, written statements,
certificates, reports, affidavits, and any
other evidence the ALJ or attorney
adjudicator admits. The record will also
include any evidence excluded or not
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considered by the ALJ or attorney
adjudicator, including but not limited to
duplicative evidence submitted by the
enrollee.
(3) An enrollee may request and
receive a copy of the record prior to or
at the hearing, or, if a hearing is not
held, at any time before the notice of
decision is issued.
(4) If a request for review is filed, the
complete record, including any
prehearing and posthearing conference
and hearing recordings, is forwarded to
the Council.
(5) A typed transcription of the
hearing is prepared if an enrollee seeks
judicial review of the case in a Federal
district court within the stated time
period and all other jurisdictional
criteria are met, unless, upon the
Secretary’s motion prior to the filing of
an answer, the court remands the case.
(b) Requesting and receiving copies of
the record. (1) While an appeal is
pending at OMHA, an enrollee may
request and receive a copy of all or part
of the record from OMHA, including
any index of the administrative record,
documentary evidence, and a copy of
the audio recording of the oral
proceedings. The enrollee may be asked
to pay the costs of providing these
items.
(2) If an enrollee requests a copy of all
or part of the record from OMHA or the
ALJ or attorney adjudicator and an
opportunity to comment on the record,
any adjudication period that applies in
accordance with § 423.2016 is extended
by the time beginning with the receipt
of the request through the expiration of
the time granted for the enrollee’s
response.
(3) If the enrollee requests a copy of
all or part of the record and the record,
including any audio recordings,
contains information pertaining to an
individual that the enrollee is not
entitled to receive, such as personally
identifiable information or protected
health information, such portions of the
record will not be furnished unless the
enrollee obtains consent from the
individual.
■ 123. Section 423.2044 is revised to
read as follows:
§ 423.2044
Consolidated proceedings.
(a) Consolidated hearing. (1) A
consolidated hearing may be held if one
or more of the issues to be considered
at the hearing are the same issues that
are involved in one or more other
appeals pending before the same ALJ.
(2) It is within the discretion of the
ALJ to grant or deny an enrollee’s
request for consolidation. In considering
an enrollee’s request, the ALJ may
consider factors such as whether the
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issue(s) may be more efficiently decided
if the appeals are consolidated for
hearing. In considering the enrollee’s
request for consolidation, the ALJ must
take into account any adjudication
deadlines for each appeal and may
require an enrollee to waive the
adjudication deadline associated with
one or more appeals if consolidation
otherwise prevents the ALJ from
deciding all of the appeals at issue
within their respective deadlines.
(3) The ALJ may also propose on his
or her own motion to consolidate two or
more appeals in one hearing for
administrative efficiency, but may not
require an enrollee to waive the
adjudication deadline for any of the
consolidated cases.
(4) Notice of a consolidated hearing
must be included in the notice of
hearing issued in accordance with
§§ 423.2020 and 423.2022.
(b) Consolidated decision and record.
(1) If the ALJ decides to hold a
consolidated hearing, he or she may
make either—
(i) A consolidated decision and
record; or
(ii) A separate decision and record on
each appeal.
(2) If a separate decision and record
on each appeal is made, the ALJ is
responsible for making sure that any
evidence that is common to all appeals
and material to the common issue to be
decided, and audio recordings of any
conferences that were conducted and
the consolidated hearing are included in
each individual administrative record,
as applicable.
(3) If a hearing will not be conducted
for multiple appeals that are before the
same ALJ or attorney adjudicator, and
the appeals involve one or more of the
same issues, the ALJ or attorney
adjudicator may make a consolidated
decision and record at the request of the
enrollee or on the ALJ’s or attorney
adjudicator’s own motion.
(c) Limitation on consolidated
proceedings. Consolidated proceedings
may only be conducted for appeals filed
by the same enrollee, unless multiple
enrollees aggregated appeals to meet the
amount in controversy requirement in
accordance with § 423.1970 and the
enrollees have all authorized disclosure
of information to the other enrollees.
■ 124. Section 423.2046 is revised to
read as follows:
§ 423.2046 Notice of an ALJ or attorney
adjudicator decision.
(a) Decisions on requests for hearing—
(1) General rule. Unless the ALJ or
attorney adjudicator dismisses or
remands the request for hearing, the ALJ
or attorney adjudicator will issue a
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written decision that gives the findings
of fact, conclusions of law, and the
reasons for the decision.
(i) The decision must be based on
evidence offered at the hearing or
otherwise admitted into the record, and
shall include independent findings and
conclusions.
(ii) A copy of the decision should be
mailed or otherwise transmitted to the
enrollee at his or her last known
address.
(iii) A copy of the written decision
should also be provided to the IRE that
issued the reconsideration
determination, and to the Part D plan
sponsor that issued the coverage
determination.
(2) Content of the notice. The decision
must be provided in a manner
calculated to be understood by an
enrollee and must include—
(i) The specific reasons for the
determination, including, to the extent
appropriate, a summary of any clinical
or scientific evidence used in making
the determination;
(ii) The procedures for obtaining
additional information concerning the
decision; and
(iii) Notification of the right to appeal
the decision to the Council, including
instructions on how to initiate an appeal
under this section.
(3) Limitation on decision. When the
amount of payment for the Part D drug
is an issue before the ALJ or attorney
adjudicator, the ALJ or attorney
adjudicator may make a finding as to the
amount of payment due. If the ALJ or
attorney adjudicator makes a finding
concerning payment when the amount
of payment was not an issue before the
ALJ or attorney adjudicator, the Part D
plan sponsor may independently
determine the payment amount. In
either of the aforementioned situations,
an ALJ’s or attorney adjudicator’s
decision is not binding on the Part D
plan sponsor for purposes of
determining the amount of payment
due. The amount of payment
determined by the Part D plan sponsor
in effectuating the ALJ’s or attorney
adjudicator’s decision is a new coverage
determination under § 423.566.
(b) Decisions on requests for review of
an IRE dismissal—(1) General rule.
Unless the ALJ or attorney adjudicator
dismisses the request for review of an
IRE dismissal, or the dismissal is
vacated and remanded, the ALJ or
attorney adjudicator will issue a written
decision affirming the IRE’s dismissal.
OMHA mails or otherwise transmits a
copy of the decision to the enrollee.
(2) Content of the notice. The decision
must be written in a manner calculated
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to be understood by an enrollee and
must include—
(i) The specific reasons for the
determination, including a summary of
the evidence considered and applicable
authorities;
(ii) The procedures for obtaining
additional information concerning the
decision; and
(iii) Notification that the decision is
binding and is not subject to further
review, unless reopened and revised by
the ALJ or attorney adjudicator.
(c) Recommended decision. An ALJ or
attorney adjudicator issues a
recommended decision if he or she is
directed to do so in the Council’s
remand order. An ALJ or attorney
adjudicator may not issue a
recommended decision on his or her
own motion. The ALJ or attorney
adjudicator mails a copy of the
recommended decision to the enrollee
at his or her last known address.
■ 125. Section 423.2048 is revised to
read as follows:
§ 423.2048 The effect of an ALJ’s or
attorney adjudicator’s decision.
(a) The decision of the ALJ or attorney
adjudicator on a request for hearing is
binding unless—
(1) An enrollee requests a review of
the decision by the Council within the
stated time period or the Council
reviews the decision issued by an ALJ
or attorney adjudicator under the
procedures set forth in § 423.2110, and
the Council issues a final decision or
remand order;
(2) The decision is reopened and
revised by an ALJ or attorney
adjudicator or the Council under the
procedures explained in § 423.1980;
(3) The expedited access to judicial
review process at § 423.1990 is used;
(4) The ALJ’s or attorney adjudicator’s
decision is a recommended decision
directed to the Council and the Council
issues a decision; or
(5) In a case remanded by a Federal
district court, the Council assumes
jurisdiction under the procedures in
§ 423.2138 and the Council issues a
decision.
(b) The decision of the ALJ or attorney
adjudicator on a request for review of an
IRE dismissal is binding on the enrollee
unless the decision is reopened and
revised by the ALJ or attorney
adjudicator under the procedures
explained in § 423.1980.
§ 423.2050
[Amended]
126. Section 423.2050 is amended
by—
■ a. Amending the section heading by
removing the phrase ‘‘an ALJ’’ and
adding ‘‘OMHA’’ in its place.
■
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b. Amending the text of the section by
removing the phrase ‘‘pending before an
ALJ’’ and adding ‘‘pending before
OMHA’’ in its place, and by removing
the term ‘‘the ALJ’’ and adding
‘‘OMHA’’ in its place.
■ c. Amending the section heading and
the text of the section by removing the
term ‘‘MAC’’ each time it appears and
adding ‘‘Council’’ in its place.
■ 127. Section 423.2052 is revised to
read as follows:
■
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§ 423.2052 Dismissal of a request for a
hearing before an ALJ or request for review
of an IRE dismissal.
(a) Dismissal of request for hearing.
An ALJ dismisses a request for a hearing
under any of the following conditions:
(1) Neither the enrollee that requested
the hearing nor the enrollee’s
representative appears at the time and
place set for the hearing, if—
(i) The enrollee was notified before
the time set for the hearing that the
request for hearing might be dismissed
for failure to appear, the record contains
documentation that the enrollee
acknowledged the notice of hearing, and
the enrollee does not contact the ALJ
within 10 calendar days after the
hearing for non-expedited hearings and
2 calendar days after the hearing for
expedited hearings, or does contact the
ALJ but the ALJ determines the enrollee
did not demonstrate good cause for not
appearing; or
(ii) The record does not contain
documentation that the enrollee
acknowledged the notice of hearing, the
ALJ sends a notice to the enrollee at his
or her last known address asking why
the enrollee did not appear, and the
enrollee does not respond to the ALJ’s
notice within 10 calendar days for nonexpedited hearings or within 2 calendar
days for expedited hearings after
receiving the notice, or does contact the
ALJ but the ALJ determines the enrollee
did not demonstrate good cause for not
appearing. For expedited hearings, an
enrollee may submit his or her response
orally to the ALJ.
(iii) In determining whether good
cause exists under paragraphs (a)(1)(i)
and (ii) of this section, the ALJ
considers any physical, mental,
educational, or linguistic limitations
(including any lack of facility with the
English language) the enrollee may
have.
(2) The person requesting a hearing
has no right to it under § 423.2002.
(3) The enrollee did not request a
hearing within the stated time period
and the ALJ or attorney adjudicator has
not found good cause for extending the
deadline, as provided in § 423.2014(e).
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(4) The enrollee died while the
request for hearing is pending and the
request for hearing was filed by the
enrollee or the enrollee’s representative,
and the enrollee’s surviving spouse or
estate has no remaining financial
interest in the case and the enrollee’s
representative, if any, does not wish to
continue the appeal.
(5) The ALJ or attorney adjudicator
dismisses a hearing request entirely or
refuses to consider any one or more of
the issues because an IRE, an ALJ or
attorney adjudicator, or the Council has
made a previous determination or
decision under this subpart about the
enrollee’s rights on the same facts and
on the same issue(s), and this previous
determination or decision has become
binding by either administrative or
judicial action.
(6) The enrollee abandons the request
for hearing. An ALJ or attorney
adjudicator may conclude that an
enrollee has abandoned a request for
hearing when OMHA attempts to
schedule a hearing and is unable to
contact the enrollee after making
reasonable efforts to do so.
(7) The enrollee’s request is not
complete in accordance with
§ 423.2014(a)(1), even after the enrollee
is provided with an opportunity to
complete the request.
(b) Dismissal of request for review of
IRE dismissal. An ALJ or attorney
adjudicator dismisses a request for
review of an IRE dismissal under any of
the following conditions:
(1) The enrollee has no right to a
review of the IRE dismissal under
§ 423.2004.
(2) The enrollee did not request a
review within the stated time period
and the ALJ or attorney adjudicator has
not found good cause for extending the
deadline, as provided in § 423.2014(e).
(3) The enrollee died while the
request for review was pending and the
request was filed by the enrollee or the
enrollee’s representative, and the
enrollee’s surviving spouse or estate has
no remaining financial interest in the
case and the enrollee’s representative, if
any, does not wish to continue the
appeal.
(4) The enrollee’s request is not
complete in accordance with
§ 423.2014(a)(1), even after the enrollee
is provided with an opportunity to
complete the request.
(c) Withdrawal of request. At any time
before notice of the decision, dismissal,
or remand is mailed, if the enrollee asks
to withdraw the request, an ALJ or
attorney adjudicator may dismiss the
request for hearing or request for review
of an IRE dismissal. This request for
withdrawal may be submitted in
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writing, or a request to withdraw a
request for hearing may be made orally
at a hearing before the ALJ. The request
for withdrawal must include a clear
statement that the enrollee is
withdrawing the request for hearing or
review of the IRE dismissal and does not
intend to further proceed with the
appeal. If an attorney or other legal
professional on behalf of an enrollee
files the request for withdrawal, the ALJ
or attorney adjudicator may presume
that the representative has advised the
enrollee of the consequences of the
withdrawal and dismissal.
(d) Notice of dismissal. OMHA mails
or otherwise transmits a written notice
of the dismissal of the hearing or review
request to the enrollee at his or her last
known address. The written notice
provides that there is a right to request
that the ALJ or attorney adjudicator
vacate the dismissal action.
(e) Vacating a dismissal. If good and
sufficient cause is established, the ALJ
or attorney adjudicator may vacate his
or her dismissal of a request for hearing
or review within 6 months of the date
of the notice of dismissal.
■ 128. Section 423.2054 is revised to
read as follows:
§ 423.2054 Effect of dismissal of a request
for a hearing or request for review of an
IRE’s dismissal.
(a) The dismissal of a request for a
hearing is binding, unless it is vacated
by the Council under § 423.2108(b), or
vacated by the ALJ or attorney
adjudicator under § 423.2052(e).
(b) The dismissal of a request for
review of an IRE dismissal of a request
for reconsideration is binding and not
subject to further review unless vacated
by the ALJ or attorney adjudicator under
§ 423.2052(e).
■ 129. Section 423.2056 is added to read
as follows:
§ 423.2056 Remands of requests for
hearing and requests for review.
(a) Missing appeal determination or
case record. (1) If an ALJ or attorney
adjudicator requests an official copy of
a missing redetermination or
reconsideration for an appealed
coverage determination in accordance
with § 423.2034, and the IRE, CMS, or
Part D plan sponsor does not furnish the
copy within the time frame specified in
§ 423.2034, an ALJ or attorney
adjudicator may issue a remand
directing the IRE or Part D plan sponsor
to reconstruct the record or, if it is not
able to do so, initiate a new appeal
adjudication.
(2) If the IRE does not furnish the case
file for an appealed reconsideration, an
ALJ or attorney adjudicator may issue a
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remand directing the IRE to reconstruct
the record or, if it is not able to do so,
initiate a new appeal adjudication.
(3) If the IRE or Part D plan sponsor
is able to reconstruct the record for a
remanded case and returns the case to
OMHA, the case is no longer remanded
and the reconsideration is no longer
vacated, and any adjudication period
that applies to the appeal in accordance
with § 423.2016 is extended by the
period between the date of the remand
and the date that case is returned to
OMHA.
(b) No redetermination. If an ALJ or
attorney adjudicator finds that the IRE
issued a reconsideration and no
redetermination was made with respect
to the issue under appeal or the request
for redetermination was dismissed, the
reconsideration will be remanded to the
IRE, or its successor, to re-adjudicate the
request for reconsideration.
(c) Requested remand—(1) Request
contents and timing. At any time prior
to an ALJ or attorney adjudicator issuing
a decision or dismissal, the enrollee and
CMS, the IRE, or the Part D plan sponsor
may jointly request a remand of the
appeal to the IRE. The request must
include the reasons why the appeal
should be remanded, and indicate
whether remanding the case will likely
resolve the matter in dispute.
(2) Granting the request. An ALJ or
attorney adjudicator may grant the
request and issue a remand if he or she
determines that remanding the case will
likely resolve the matter in dispute.
(d) Remanding an IRE’s dismissal of
a request for reconsideration. Consistent
with § 423.2004(b), an ALJ or attorney
adjudicator will remand a case to the
appropriate IRE if the ALJ or attorney
adjudicator determines that an IRE’s
dismissal of a request for
reconsideration was in error.
(e) Consideration of change in
condition. The ALJ or attorney
adjudicator will remand a case to the
appropriate IRE if the ALJ or attorney
adjudicator determines that the enrollee
wants evidence on his or her change in
condition after the coverage
determination to be considered in the
appeal.
(f) Notice of a remand. OMHA mails
or otherwise transmits a written notice
of the remand of the request for hearing
or request for review to the enrollee at
his or her last known address, and CMS,
the IRE, and/or the Part D plan sponsor
if a request to be a participant was
granted by the ALJ or attorney
adjudicator. The notice states that there
is a right to request that the Chief ALJ
or a designee review the remand.
(g) Review of remand. Upon a request
by the enrollee or CMS, the IRE, or the
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Part D plan sponsor filed within 30
calendar days of receiving a notice of
remand, the Chief ALJ or designee will
review the remand, and if the remand is
not authorized by this section, vacate
the remand order. The determination on
a request to review a remand order is
binding and not subject to further
review.
■ 130. Section 423.2058 is added to read
as follows:
§ 423.2058
Effect of a remand.
A remand of a request for hearing or
request for review is binding unless
vacated by the Chief ALJ or a designee
in accordance with § 423.2056(g).
§ 423.2062
[Amended]
131. Section 423.2062 is amended
by—
■ a. Amending the section heading and
paragraphs (a) and (b) by removing the
term ‘‘MAC’’ each time it appears and
adding ‘‘Council’’ in its place.
■ b. Amending paragraph (a) by
removing the term ‘‘ALJs’’ and adding
‘‘ALJs and attorney adjudicators’’ in its
place.
■ c. Amending paragraph (b) by
removing the term ‘‘ALJ’’ each time it
appears and adding ‘‘ALJ or attorney
adjudicator’’ in its place.
■ 132. Section 423.2063 is revised to
read as follows:
■
§ 423.2063 Applicability of laws,
regulations, CMS Rulings, and precedential
decisions.
(a) All laws and regulations pertaining
to the Medicare program, including, but
not limited to Titles XI, XVIII, and XIX
of the Social Security Act and
applicable implementing regulations,
are binding on ALJs and attorney
adjudicators, and the Council.
(b) CMS Rulings are published under
the authority of the CMS Administrator.
Consistent with § 401.108 of this
chapter, rulings are binding on all CMS
components, and on all HHS
components that adjudicate matters
under the jurisdiction of CMS.
(c) Precedential decisions designated
by the Chair of the Departmental
Appeals Board in accordance with
§ 401.109 of this chapter are binding on
all CMS components, and all HHS
components that adjudicate matters
under the jurisdiction of CMS.
■ 133. Section 423.2100 is revised to
read as follows:
§ 423.2100 Medicare Appeals Council
review: general.
(a) Consistent with § 423.1974, the
enrollee may request that the Council
review an ALJ’s or attorney
adjudicator’s decision or dismissal.
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(b) When the Council reviews an
ALJ’s or attorney adjudicator’s written
decision, it undertakes a de novo
review.
(c) The Council issues a final
decision, dismissal order, or remands a
case to the ALJ or attorney adjudicator
no later than the end of the 90 calendar
day period beginning on the date the
request for review is received (by the
entity specified in the ALJ’s or attorney
adjudicator’s written notice of decision),
unless the 90 calendar day period is
extended as provided in this subpart or
the enrollee requests expedited Council
review.
(d) If an enrollee requests expedited
Council review, the Council issues a
final decision, dismissal order or
remand as expeditiously as the
enrollee’s health condition requires, but
no later than the end of the 10 calendar
day period beginning on the date the
request for review is received (by the
entity specified in the ALJ’s or attorney
adjudicator’s written notice of decision),
unless the 10 calendar day period is
extended as provided in this subpart.
■ 134. Section 423.2102 is revised to
read as follows:
§ 423.2102 Request for Council review
when ALJ or attorney adjudicator issues
decision or dismissal.
(a)(1) An enrollee may request
Council review of a decision or
dismissal issued by an ALJ or attorney
adjudicator if the enrollee files a written
request for a Council review within 60
calendar days after receipt of the ALJ’s
or attorney adjudicator’s written
decision or dismissal.
(2) An enrollee may request that
Council review be expedited if the
appeal involves an issue specified in
§ 423.566(b) but does not include solely
a request for payment of Part D drugs
already furnished.
(i) If an enrollee is requesting that the
Council review be expedited, the
enrollee submits an oral or written
request within 60 calendar days after
the receipt of the ALJ’s or attorney
adjudicator’s written decision or
dismissal. A prescribing physician or
other prescriber may provide oral or
written support for an enrollee’s request
for expedited review.
(ii) The Council must document all
oral requests for expedited review in
writing and maintain the documentation
in the case files.
(3) For purposes of this section, the
date of receipt of the ALJ’s or attorney
adjudicator’s written decision or
dismissal is presumed to be 5 calendar
days after the date of the notice of the
decision or dismissal, unless there is
evidence to the contrary.
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(4) The request is considered as filed
on the date it is received by the entity
specified in the notice of the ALJ’s or
attorney adjudicator’s action.
(b) An enrollee requesting a review
may ask that the time for filing a request
for Council review be extended if—
(1) The request for an extension of
time is in writing or, for expedited
reviews, in writing or oral. The Council
must document all oral requests in
writing and maintain the documentation
in the case file.
(2) The request explains why the
request for review was not filed within
the stated time period. If the Council
finds that there is good cause for
missing the deadline, the time period
will be extended. To determine whether
good cause exists, the Council uses the
standards outlined at § 405.942(b)(2)
and (3) of this chapter.
(c) An enrollee does not have the right
to seek Council review of an ALJ’s or
attorney adjudicator’s remand to an IRE,
or an ALJ’s or attorney adjudicator’s
affirmation of an IRE’s dismissal of a
request for reconsideration, or dismissal
of a request to review an IRE dismissal.
§ 423.2106
[Amended]
135. Section 423.2106 is amended
by—
■ a. Removing the term ‘‘ALJ’’ and
adding ‘‘ALJ or attorney adjudicator’’ in
its place.
■ b. Removing the term ‘‘ALJ’s’’ each
time it appears and adding ‘‘ALJ’s or
attorney adjudicator’s’’ in its place.
■ c. Removing the term ‘‘MAC’’ each
time it appears and adding ‘‘Council’’ in
its place.
■ d. Removing the term ‘‘MAC’s’’ and
adding ‘‘Council’s’’ in its place.
■
§ 423.2108
[Amended]
136. Section 423.2108 is amended
by—
■ a. Amending paragraphs (a), (b), and
(c) by removing the term ‘‘ALJ’’ and
adding ‘‘ALJ or attorney adjudicator’’ in
its place.
■ b. Amending paragraphs (a) and
(d)(2)(iii) by removing the term ‘‘ALJ’s’’
each time it appears and adding ‘‘ALJ’s
or attorney adjudicator’s’’ in its place.
■ c. Amending the section heading and
paragraphs (a), (b), (c), (d)(1), (d)(2)
introductory text, (d)(3) introductory
text, and (d)(3)(ii) by removing the term
‘‘MAC’’ each time it appears and adding
‘‘Council’’ in its place.
■ d. Amending paragraph (a) by
removing the term ‘‘MAC’s’’ and adding
‘‘Council’s’’ in its place.
■ e. Amending the paragraph heading
and text of paragraph (b) by removing
the phrase ‘‘ALJ’s dismissal’’ and adding
‘‘ALJ’s or attorney adjudicator’s
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■
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dismissal of a request for a hearing’’ in
its place.
■ 137. Section 423.2110 is revised to
read as follows:
§ 423.2110
motion.
Council reviews on its own
(a) General rule. The Council may
decide on its own motion to review a
decision or dismissal issued by an ALJ
or attorney adjudicator. CMS or the IRE
may refer a case to the Council for it to
consider reviewing under this authority
any time within 60 calendar days after
the date of an ALJ’s or attorney
adjudicator’s written decision or
dismissal.
(b) Referral of cases. (1) CMS or the
IRE may refer a case to the Council if,
in the view of CMS or the IRE, the
decision or dismissal contains an error
of law material to the outcome of the
appeal or presents a broad policy or
procedural issue that may affect the
public interest. CMS or the IRE may also
request that the Council take own
motion review of a case if—
(i) CMS or the IRE participated or
requested to participate in the appeal at
the OMHA level; and
(ii) In CMS’ or the IRE’s view, the
ALJ’s or attorney adjudicator’s decision
or dismissal is not supported by the
preponderance of evidence in the record
or the ALJ or attorney adjudicator
abused his or her discretion.
(2) CMS’ or the IRE’s referral to the
Council is made in writing and must be
filed with the Council no later than 60
calendar days after the ALJ’s or attorney
adjudicator’s written decision or
dismissal is issued.
(i) The written referral will state the
reasons why CMS or the IRE believes
that the Council should review the case
on its own motion.
(ii) CMS or the IRE will send a copy
of its referral to the enrollee and to the
OMHA Chief ALJ.
(iii) The enrollee may file exceptions
to the referral by submitting written
comments to the Council within 20
calendar days of the referral notice.
(iv) An enrollee submitting comments
to the Council must send the comments
to CMS or the IRE.
(c) Standard of review—(1) Referral by
CMS or the IRE when CMS or the IRE
participated or requested to participate
in the OMHA level. If CMS or the IRE
participated or requested to participate
in an appeal at the OMHA level, the
Council exercises its own motion
authority if there is an error of law
material to the outcome of the case, an
abuse of discretion by the ALJ or
attorney adjudicator, the decision is not
consistent with the preponderance of
the evidence of record, or there is a
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broad policy or procedural issue that
may affect the general public interest. In
deciding whether to accept review
under this standard, the Council will
limit its consideration of the ALJ’s or
attorney adjudicator’s action to those
exceptions raised by CMS or the IRE.
(2) Referral by CMS or the IRE when
CMS or the IRE did not participate or
request to participate in the OMHA
proceedings. The Council will accept
review if the decision or dismissal
contains an error of law material to the
outcome of the case or presents a broad
policy or procedural issue that may
affect the general public interest. In
deciding whether to accept review, the
Council will limit its consideration of
the ALJ’s or attorney adjudicator’s
action to those exceptions raised by
CMS or the IRE.
(d) Council’s action. (1) If the Council
decides to review a decision or
dismissal on its own motion, it will mail
the results of its action to the enrollee
and to CMS or the IRE, as appropriate.
(2) The Council may adopt, modify, or
reverse the decision or dismissal, may
remand the case to an ALJ or attorney
adjudicator for further proceedings, or
may dismiss a hearing request.
(3) The Council must issue its action
no later than 90 calendar days after
receipt of the CMS or the IRE referral,
unless the 90 calendar day period has
been extended as provided in this
subpart.
(4) The Council may not issue its
action before the 20 calendar day
comment period has expired, unless it
determines that the agency’s referral
does not provide a basis for reviewing
the case.
(5) If the Council declines to review
a decision or dismissal on its own
motion, the ALJ’s or attorney
adjudicator’s decision or dismissal is
binding.
§ 423.2112
[Amended]
138. Section 423.2112 is amended
by—
■ a. Amending paragraphs (a)(1), (b),
and (c) by removing the term ‘‘ALJ’s’’
and adding ‘‘ALJ’s or attorney
adjudicator’s’’ in its place.
■ b. Amending paragraph (b) by
removing the term ‘‘ALJ’’ and adding
‘‘ALJ or attorney adjudicator’’ in its
place.
■ c. Amending paragraphs (a)(1) and (3),
and (c) by removing the term ‘‘MAC’’
and adding ‘‘Council’’ in its place.
■
§ 423.2114
[Amended]
139. Section 423.2114 is amended in
the introductory text and paragraph (b)
by removing the term ‘‘MAC’’ each time
it appears and adding ‘‘Council’’ in its
place.
■
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[Amended]
140. Section 423.2116 is amended
by—
■ a. Removing the term ‘‘MAC’’ each
time it appears and adding ‘‘Council’’ in
its place.
■ b. Removing the term ‘‘MAC’s’’ and
adding ‘‘Council’s’’ in its place.
■ c. Removing the term ‘‘ALJ’’ and
adding ‘‘ALJ or attorney adjudicator’’ in
its place.
■
§ 423.2118
[Amended]
141. Section 423.2118 is amended
by—
■ a. Removing the term ‘‘MAC’’ each
time it appears and adding ‘‘Council’’ in
its place.
■ b. Removing the term ‘‘MAC’s’’ and
adding ‘‘Council’s’’ in its place.
■ c. Removing the phrase ‘‘ALJ hearing’’
and adding ‘‘ALJ’s or attorney
adjudicator’s action’’ in its place.
■ d. Removing the phrase ‘‘the exhibits
list’’ and adding ‘‘any index of the
administrative record’’ in its place.
■ e. Removing the term ‘‘CD’’ and
adding ‘‘audio recording’’ in its place.
■
§ 423.2120
142. Section 423.2120 is amended by
removing the term ‘‘MAC’’ each time it
appears and adding ‘‘Council’’ in its
place.
[Amended]
143. Section 423.2122 is amended
by—
■ a. Amending the section heading and
paragraphs (a) paragraph heading, (a)(1),
(2), and (3), (b) introductory text, (b)(1)
and (2), and (c)(1), (2), (3), and (4) by
removing the term ‘‘MAC’’ each time it
appears and adding ‘‘Council’’ in its
place.
■ b. Amending paragraphs (a) paragraph
heading and (a)(1) by removing the term
‘‘ALJ’s’’ and adding ‘‘ALJ’s or attorney
adjudicator’s’’ in its place.
■ c. Amending paragraph (a)(1) by
removing the term ‘‘ALJ level’’ and
adding ‘‘OMHA level’’ in its place.
■ d. Amending paragraph (a)(1) by
removing the term ‘‘hearing decision’’
and adding ‘‘ALJ’s or attorney
adjudicator’s decision’’ in its place.
■ e. Amending paragraphs (a)(1) and (2)
by removing the term ‘‘ALJ’’ and adding
‘‘ALJ or attorney adjudicator’’ in its
place.
■ f. Amending paragraph (a)(2) by
removing the term ‘‘hearing record’’ and
adding ‘‘administrative record’’ in its
place.
■ g. Amending paragraph (c)(3) by
removing the term ‘‘MAC’s’’ and adding
‘‘Council’s’’ in its place.
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■
§ 423.2124
[Amended]
144. Section 423.2124 is amended in
the introductory text and paragraphs (a),
■
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[Amended]
145. Section 423.2126 is amended
by—
■ a. Amending the section heading and
paragraphs (a) paragraph heading, (a)(1),
(2), and (3), (a)(4) paragraph heading,
(a)(4)(i) and (ii), (a)(5) paragraph
heading, (a)(5)(i) and (ii), and (b) by
removing the term ‘‘MAC’’ each time it
appears and adding ‘‘Council’’ in its
place.
■ b. Amending paragraphs (a) paragraph
heading, (a)(1), (2), and (3), (a)(4)
paragraph heading, and (a)(5)(ii) by
removing the term ‘‘ALJ’’ each time it
appears and adding ‘‘ALJ or attorney
adjudicator’’ in its place.
■ c. Amending paragraph (a)(2) by
removing the term ‘‘MAC’s and adding
‘‘Council’s’’ in its place.
■ d. Amending paragraph (a)(5)(ii) by
adding ‘‘if applicable’’ after the word
‘‘rehearing’’.
■
§ 423.2128
[Amended]
■
§ 423.2122
(b), (c), (d), and (e) by removing the term
‘‘MAC’’ each time it appears and adding
‘‘Council’’ in its place.
[Amended]
146. Section 423.2128 is amended
by—
■ a. Amending the section heading and
paragraphs (a), (b), and (c) by removing
the term ‘‘MAC’’ each time it appears
and adding ‘‘Council’’ in its place.
■ b. Amending paragraph (a) by
removing the term ‘‘ALJ’’ and adding
‘‘ALJ or attorney adjudicator’’ in its
place.
■ c. Amending paragraph (b) by
removing the phrase ‘‘ALJ hearing
decision’’ and adding ‘‘ALJ or attorney
adjudicator decision’’ in its place.
■
§ 423.2130
[Amended]
147. Section 423.2130 is amended in
the section heading and text by
removing the term ‘‘MAC’s’’ each time
it appears and adding ‘‘Council’s’’ in its
place.
■
§ 423.2134
[Amended]
148. Section 423.2134 is amended in
paragraphs (b)(3) and (c) by removing
the term ‘‘MAC’’ and adding ‘‘Council’’
in its place.
■
§ 423.2136
[Amended]
149. Section 423.2136 is amended
by—
■ a. Amending paragraphs (a) and (c)(3)
by removing the term ‘‘MAC’’ and
adding ‘‘Council’’ in its place.
■ b. Amending paragraph (c)(2) by
removing the term ‘‘MAC’s’’ and adding
‘‘Council’s’’ in its place.
■ c. Amending paragraph (c)(3) by
removing the term ‘‘ALJ’’ and adding
‘‘ALJ or attorney adjudicator’’ in its
place.
■
PO 00000
Frm 00102
Fmt 4701
Sfmt 4702
§ 423.2138
[Amended]
150. Section 423.2138 is amended
by—
■ a. Removing the term ‘‘MAC’’ each
time it appears and adding ‘‘Council’’ in
its place.
■ b. Removing the term ‘‘ALJ’’ and
adding ‘‘ALJ or attorney adjudicator’’ in
its place.
■
§ 423.2140
[Amended]
151. Section 423.2140 is amended
by—
■ a. Amending the section heading and
paragraphs (a)(1), (2), and (3), (b)(1),
(b)(2) introductory text, (b)(2)(ii), (b)(3)
and (4), (c) paragraph heading, (c)(1),
(3), and (4), and (d) by removing the
term ‘‘MAC’’ each time it appears and
adding ‘‘Council’’ in its place.
■ b. Amending the section heading and
paragraphs (a)(1), (2), and (3), (b)
paragraph heading, (b)(1), (b)(2)
introductory text, (b)(2)(i), (b)(3) and (4),
(c)(1) and (4), and (d) by removing the
term ‘‘ALJ’’ each time it appears and
adding ‘‘ALJ or attorney adjudicator’’ in
its place.
■ c. Amending paragraph (d) by
removing the term ‘‘ALJ’s’’ and adding
‘‘ALJ’s or attorney adjudicator’s’’ in its
place.
■
PART 478—RECONSIDERATIONS AND
APPEALS
152. The authority citation for part
478 continues to read as follows:
■
Authority: Secs. 1102 and 1871 of the
Social Security Act (42 U.S.C. 1302 and
1395hh).
153. Section 478.14(c)(2) is amended
by removing the phrase ‘‘part 405,
subpart G of this chapter for
determinations under Medicare Part A,
and part 405, subpart H of this chapter
for determinations under Medicare Part
B’’ and adding ‘‘part 405, subpart I of
this chapter for determinations under
Medicare Part A and Part B’’ in its place.
■ 154. Section 478.40 is amended by
revising paragraphs (a) and (c) to read as
follows:
■
§ 478.40
Beneficiary’s right to a hearing.
(a) Amount in controversy. If the
amount in controversy is at least $200,
a beneficiary (but not a provider or
practitioner) who is dissatisfied with a
QIO reconsidered determination may
request a hearing by an administrative
law judge (ALJ) of the Office of
Medicare Hearings and Appeals
(OMHA).
*
*
*
*
*
(c) Governing provisions. The
provisions of subpart I of part 405 of
this chapter apply to hearings and
appeals under this subpart unless they
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Federal Register / Vol. 81, No. 128 / Tuesday, July 5, 2016 / Proposed Rules
are inconsistent with specific provisions
in this subpart or implement statutory
provisions that are not also applicable
under section 1155 of the Social
Security Act. References in subpart I to
initial determinations made by a
Medicare contractor and
reconsiderations made by a QIC should
be read to mean initial determinations
and reconsidered determinations made
by a QIO.
■ 155. Section 478.42 is revised to read
as follows:
§ 478.42 Submitting a request for a
hearing.
(a) Where to submit the written
request. A beneficiary who wants to
obtain a hearing under § 478.40 must
submit a written request to the OMHA
office identified in the notice of the QIO
reconsidered determination.
(b) Time limit for submitting a request
for a hearing. (1) The request for a
hearing must be filed within 60 calendar
days of receipt of the notice of the QIO
reconsidered determination, unless the
time is extended for good cause as
provided in § 478.22.
(2) The date of receipt of the notice of
the reconsidered determination is
presumed to be 5 calendar days after the
date on the notice, unless there is
evidence to the contrary.
(3) A request is considered filed on
the date it is received by OMHA.
■ 156. Section 478.44 is revised to read
as follows:
§ 478.44 Determining the amount in
controversy for a hearing.
sradovich on DSK3GDR082PROD with PROPOSALS3
(a) After an individual appellant has
submitted a request for a hearing, the
ALJ or attorney adjudicator determines
VerDate Sep<11>2014
18:38 Jul 01, 2016
Jkt 238001
the amount in controversy in
accordance with § 405.1006(d) and (e) of
this chapter. When two or more
appellants submit a request for hearing,
the ALJ or attorney adjudicator
determines the amount in controversy
in accordance with § 405.1006(d) and (e)
of this chapter.
(b) If the ALJ or attorney adjudicator
determines that the amount in
controversy is less than $200, the ALJ,
without holding a hearing, or attorney
adjudicator notifies the parties that the
parties have 15 calendar days to submit
additional evidence to prove that the
amount in controversy is at least $200.
(c) At the end of the 15-day period, if
an ALJ determines that the amount in
controversy is less than $200, the ALJ,
without holding a hearing dismisses the
request for a hearing without ruling on
the substantive issues involved in the
appeal and notifies the parties and the
QIO that the QIO reconsidered
determination is conclusive for
Medicare payment purposes.
■ 157. Section 478.46 is revised to read
as follows:
§ 478.46 Medicare Appeals Council and
judicial review.
(a) The circumstances under which
the Medicare Appeals Council (Council)
will review an ALJ’s or attorney
adjudicator’s decision or dismissal are
the same as those set forth at
§§ 405.1102 (‘‘Request for Council
review when ALJ or attorney
adjudicator issues decision or
dismissal’’) and 405.1110 (‘‘Council
reviews on its own motion’’) of this
chapter.
PO 00000
Frm 00103
Fmt 4701
Sfmt 9990
43891
(b) If $2,000 or more is in controversy,
a party may obtain judicial review of a
Council decision, or an ALJ’s or attorney
adjudicator’s decision if a request for
review by the Council was denied, by
filing a civil action under the Federal
Rules of Civil Procedure within 60 days
after the date the party received notice
of the Council decision or denial.
■ 158. Section 478.48 is amended by
revising the section heading and
paragraphs (b) and (c) to read as follows:
§ 478.48 Reopening and revision of a
reconsidered determination or a decision.
*
*
*
*
*
(b) ALJ or attorney adjudicator and
Council Reopening—Applicable
procedures. The ALJ or attorney
adjudicator, or the Council, whichever
made the decision, may reopen and
revise the decision in accordance with
the procedures set forth in § 405.980 of
this chapter, which concerns reopenings
and revised decisions under subpart I of
part 405 of this chapter.
(c) Fraud or similar abusive practice.
A reconsidered determination, a review
of a DRG change, or a decision of an ALJ
or attorney adjudicator, or the Council
may be reopened and revised at any
time, if the reconsidered determination,
review, or decision was obtained
through fraud or a similar abusive
practice that does not support a formal
finding of fraud.
Approved: June 8, 2016.
Sylvia Burwell,
Secretary, Department of Health and Human
Services.
[FR Doc. 2016–15192 Filed 6–28–16; 4:15 pm]
BILLING CODE 4150–46–P
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]]>Agencies
[Federal Register Volume 81, Number 128 (Tuesday, July 5, 2016)]
[Proposed Rules]
[Pages 43789-43891]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-15192]
[[Page 43789]]
Vol. 81
Tuesday,
No. 128
July 5, 2016
Part III
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
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42 CFR Parts 401, 405, 422, et al.
Medicare Program: Changes to the Medicare Claims and Entitlement,
Medicare Advantage Organization Determination, and Medicare
Prescription Drug Coverage Determination Appeals Procedures; Proposed
Rule
Federal Register / Vol. 81 , No. 128 / Tuesday, July 5, 2016 /
Proposed Rules
[[Page 43790]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 401, 405, 422, 423, and 478
[HHS-2015-49]
RIN 0991-AC02
Medicare Program: Changes to the Medicare Claims and Entitlement,
Medicare Advantage Organization Determination, and Medicare
Prescription Drug Coverage Determination Appeals Procedures
AGENCY: Centers for Medicare & Medicaid Services, HHS.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: This proposed rule would revise the procedures that the
Department of Health and Human Services would follow at the
Administrative Law Judge level for appeals of payment and coverage
determinations for items and services furnished to Medicare
beneficiaries, enrollees in Medicare Advantage and other Medicare
competitive health plans, and enrollees in Medicare prescription drug
plans, as well as appeals of Medicare beneficiary enrollment and
entitlement determinations, and certain Medicare premium appeals. In
addition, this proposed rule would revise procedures that the
Department of Health and Human Services would follow at the Centers for
Medicare & Medicaid Services (CMS) and the Medicare Appeals Council
(Council) levels of appeal for certain matters affecting the
Administrative Law Judge level.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, no later than 5 p.m. eastern standard
time (e.s.t.) on August 29, 2016.
ADDRESSES: In commenting, refer to ``HHS-2015-49'' at the top of your
comments. Because of staff and resource limitations, we cannot accept
comments by facsimile (FAX) transmission. We will not accept comments
submitted after the comment period.
You may submit comments in one of two ways (to ensure that we do
not receive duplicate copies, please choose only one of the ways
listed):
1. Electronically. You may submit electronic comments on this
proposed rule at www.regulations.gov. For new users, you can find
instructions on how to find a proposed rule and submit comments under
the ``Help'' tab at www.regulations.gov.
If you are submitting comments electronically, we strongly
encourage you to submit any comments or attachments in Microsoft Word
format. If you must submit a comment in Portable Document Format (PDF),
we strongly encourage you to convert the PDF to print-to-PDF format or
to use some other commonly used searchable text format. Please do not
submit the PDF in a scanned or read-only format. Using a print-to-PDF
format allows us to electronically search and copy certain portions of
your submissions.
2. U.S. Mail or commercial delivery. You may send written comments
to the following address ONLY: Office of Medicare Hearings and Appeals,
Department of Health and Human Services, Attention: HHS-2015-49, 5201
Leesburg Pike, Suite 1300, Falls Church, VA 22041.
Please allow sufficient time for mailed comments to be received
before the close of the comment period.
Privacy Note: Because comments will be made available for public
viewing in their entirety on the Federal eRulemaking portal, commenters
should exercise caution and only include in their comments information
that they wish to make publicly available.
For information on viewing public comments, see the beginning of
the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT:
Rita Wurm, (410) 786-1139 (for issues related to CMS appeals
policies and reopening policies).
Jason Green, (571) 777-2723 (for issues related to Administrative
Law Judge appeals policies).
Debbie Nobleman, (202) 565-0139 (for issues related to Council
appeals policies).
SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: All comments received before the
close of the comment period are available for viewing by the public,
including any personally identifiable or confidential business
information that is included in a comment. We will post all comments
received before the close of the comment period on the following Web
site as soon as possible after they have been received:
www.regulations.gov. Follow the search instructions on that Web site to
view public comments.
Comments received timely will also be available for public
inspection as they are received, generally beginning approximately 4
weeks after publication of a document, at the headquarters of the
Office of Medicare Hearings and Appeals, 1700 North Moore Street, Suite
1650, Arlington, Virginia 22209, Monday through Friday of each week
from 8:30 a.m. to 4:00 p.m. To schedule an appointment to view public
comments, phone (703) 235-0635.
Abbreviations
Because we refer to a number of terms by abbreviation or a
shortened form in this proposed rule, we are listing these
abbreviations and shortened forms, and their corresponding terms in
alphabetical order below:
Act--Social Security Act
ALJ--Administrative Law Judge
APA--Administrative Procedures Act
BIPA--Medicare, Medicaid, and SCHIP Benefits Improvement and
Protection Act of 2000 (Pub. L. 106-554)
CMS--Centers for Medicare & Medicaid Services
Council--Medicare Appeals Council
DAB--Departmental Appeals Board
HHS--U.S. Department of Health and Human Services
IRE--Independent Review Entity
IRMAA--Income Related Monthly Adjustment Amount
MA--Medicare Advantage
MAO--Medicare Advantage Organization
MMA--Medicare Prescription Drug, Improvement, and Modernization Act
of 2003 (Pub. L. 108-173)
OIG--HHS Office of Inspector General
OMHA--Office of Medicare Hearings and Appeals
QIC--Qualified Independent Contractor
QIO--Quality Improvement Organization
SSA--Social Security Administration
Section 1557 of the Affordable Care Act
Independent of the standards proposed in this rule, the Department
commits to complying with section 1557 of the Affordable Care Act,
Public Law 111-148, 124 Stat. 470 (42 U.S.C. 18116), which prohibits
discrimination on the basis of race, color, national origin, sex, age,
or disability in certain health programs and activities. HHS issued a
proposed rule to implement section 1557, Nondiscrimination in Health
Programs and Activities, on September 8, 2015. 80 FR 54172. The
proposed rule would apply, in part, to health programs and activities
administered by the Department.
Table of Contents
I. Background
II. General Provisions of the Proposed Regulations
A. Precedential Final Decisions of the Secretary
B. Attorney Adjudicators
C. Application of 405 Rules to Other Parts
D. OMHA References
E. Medicare Appeals Council References
III. Specific Provisions of the Proposed Rule
A. Provisions of Part 405, subpart I and Part 423, subparts M
and U
1. Overview
[[Page 43791]]
2. General provisions, reconsiderations, reopenings, and
expedited access to judicial review
a. Part 423, subpart M general provisions (Sec. 423.562)
b. Part 423, subpart U title and scope (Sec. 423.1968)
c. Medicare initial determinations, redeterminations and appeals
general description (Sec. 405.904)
d. Parties to the initial determinations, redeterminations,
reconsiderations proceedings on a request for hearing, and Council
review (Sec. 405.906)
e. Medicaid State agencies (Sec. 405.908)
f. Appointed representatives (Sec. 405.910)
g. Actions that are not initial determinations (Sec. 405.926)
h. Notice of a redetermination (Sec. 405.956)
i. Time frame for making a reconsideration following a
contractor redetermination, withdrawal or dismissal of a request for
a reconsideration, and reconsideration (Sec. Sec. 405.970, 405.972,
and 405.974)
j. Notice of reconsideration (Sec. 405.976)
k. Effect of a reconsideration (Sec. 405.978)
l. Reopenings (Sec. Sec. 405.980, 405.982, 405.984, 423.1978,
423.1980, 423.1982, and 423.1984)
m. Expedited access to judicial review (Sec. Sec. 405.990 and
423.1990)
3. ALJ hearings
a. Hearing before an ALJ and decision by an ALJ and attorney
adjudicator: General rule (Sec. Sec. 405.1000 and 423.2000)
b. Right to an ALJ hearing (Sec. Sec. 405.1002 and 423.2002)
c. Right to a review of QIC or IRE notice of dismissal
(Sec. Sec. 405.1004 and 423.2004)
d. Amount in controversy required for an ALJ hearing (Sec. Sec.
405.1006 and 423.1970)
e. Parties to an ALJ hearing (Sec. Sec. 405.1008 and 423.2008)
f. CMS and CMS contractors as participants or parties in the
adjudication process (Sec. Sec. 405.1010, 405.1012, and 423.2010)
i. Section 405.1010: When CMS or its contractors may participate
in the proceedings on a request for an ALJ hearing
ii. Section 423.2010: When CMS, the IRE, or Part D plan sponsors
may participate in the proceedings on a request for an ALJ hearing
iii. Section 405.1012: When CMS or its contractors may be a
party to a hearing
g. Request for an ALJ hearing or review of a QIC or an IRE
dismissal (Sec. Sec. 405.1014, 423.1972 and 423.2014)
i. Requirements for a request for hearing or review of a QIC or
an IRE dismissal
ii. Requests for hearing involving statistical sampling and
extrapolations
iii. Opportunity to cure defective filings
iv. Where and when to file a request for hearing or review of a
QIC or an IRE dismissal
v. Sending copies of a request for hearing and other evidence to
other parties to the appeal
vi. Extending time to file a request for hearing or review of a
QIC or an IRE dismissal
h. Time frames for deciding an appeal of a QIC or an IRE
reconsideration or an escalated request for a QIC reconsideration,
and request for Council review when an ALJ does not issue a decision
timely (Sec. Sec. 405.1016, 405.1104 and 423.2016)
i. Section 405.1016: Time frames for deciding an appeal of a QIC
or an escalated request for a QIC reconsideration
ii. Section 405.1104: Request for Council review when an ALJ
does not issue a decision timely
iii. Section 423.2016: Time frames for deciding an appeal of an
IRE reconsideration
i. Submitting evidence (Sec. Sec. 405.1018 and 423.2018)
j. Time and place for a hearing before an ALJ (Sec. Sec.
405.1020 and 423.2020)
k. Notice of a hearing before an ALJ and objections to the
issues (Sec. Sec. 405.1022, 405.1024, 423.2022, and 423.2024)
l. Disqualification of the ALJ or attorney adjudicator
(Sec. Sec. 405.1026 and 423.2026)
m. Review of evidence submitted by the parties (Sec. 405.1028)
n. ALJ hearing procedures (Sec. Sec. 405.1030 and 423.2030)
o. Issues before an ALJ or attorney adjudicator (Sec. Sec.
405.1032, 405.1064 and 423.2032)
p. Requesting information from the QIC or IRE, and remanding an
appeal (Sec. Sec. 405.1034, 405.1056, 405.1058, 423.2034, 423.2056,
and 423.2058)
q. Description of the ALJ hearing process and discovery
(Sec. Sec. 405.1036, 405.1037, and 423.2036)
r. Deciding a case without a hearing before an ALJ (Sec. Sec.
405.1038 and 423.2038)
s. Prehearing and posthearing conferences (Sec. Sec. 405.1040
and 423.2040)
t. The administrative record (Sec. Sec. 405.1042 and 423.2042)
u. Consolidated proceedings (Sec. Sec. 405.1044 and 423.2044)
v. Notice of decision and effect of an ALJ's or attorney
adjudicator's decision (Sec. Sec. 405.1046, 405.1048, 423.2046, and
423.2048)
w. Removal of a hearing request from an ALJ to the Council
(Sec. Sec. 405.1050 and 423.2050)
x. Dismissal of a request for hearing or request for review and
effect of a dismissal of a request for hearing or request for review
(Sec. Sec. 405.1052, 405.1054, 423.2052 and 423.2054)
4. Applicability of Medicare coverage policies (Sec. Sec.
405.1060, 405.1062, 405.1063, 423.2062, and 423.2063)
5. Council review and judicial review
a. Council review: general (Sec. Sec. 405.1100, 423.1974 and
423.2100)
b. Request for Council review when ALJ issues decision or
dismissal (Sec. Sec. 405.1102 and 423.2102)
c. Where a request for review or escalation may be filed
(Sec. Sec. 405.1106 and 423.2106)
d. Council actions when request for review or escalation is
filed (Sec. Sec. 405.1108 and 423.2108)
e. Council reviews on its own motion (Sec. Sec. 405.1110 and
423.2110).
f. Content of request for review (Sec. Sec. 405.1112 and
423.2112).
g. Dismissal of request for review (Sec. Sec. 405.1114 and
423.2114)
h. Effect of dismissal of request for Council review or request
for hearing (Sec. Sec. 405.1116 and 423.2116)
i. Obtaining evidence from the Council (Sec. Sec. 405.1118 and
423.2118)
j. What evidence may be submitted to the Council (Sec. Sec.
405.1122 and 423.2122)
k. Case remanded by the Council (Sec. Sec. 405.1126 and
423.2126)
l. Action of the Council (Sec. Sec. 405.1128 and 423.2128)
m. Request for escalation to Federal court (Sec. 405.1132)
n. Judicial review (Sec. Sec. 405.1136, 423.1976, and 423.2136)
o. Case remanded by a Federal court (Sec. Sec. 405.1038 and
423.2138)
p. Council review of ALJ decision in a case remanded by a
Federal district court (Sec. Sec. 405.1140 and 423.2140)
B. Part 405, subpart J expedited reconsiderations (Sec.
405.1204)
C. Part 422, subpart M
1. General provisions (Sec. 422.562).
2. Notice of reconsidered determination by the independent
entity (Sec. 422.594).
3. Request for an ALJ hearing (Sec. 422.602).
4. Medicare Appeals Council (Council) review (Sec. 422.608).
5. Judicial review (Sec. 422.612)
6. Reopening and revising determinations and decisions (Sec.
422.616)
7. How an MA organization must effectuate standard
reconsideration determinations and decisions, and expedited
reconsidered determinations (Sec. Sec. 422.618 and 422.619)
8. Requesting immediate QIO review of the decision to discharge
from the inpatient hospital and fast-track appeals of service
terminations to independent review entities (IREs) (Sec. Sec.
422.622 and 422.626).
D. Part 478, subpart B
1. Applicability and beneficiary's right to a hearing
(Sec. Sec. 478.14 and 478.40)
2. Submitting a request for a hearing (Sec. 478.42)
3. Determining the amount in controversy (Sec. 478.44)
4. Medicare Appeals Council and judicial review (Sec. 478.46)
5. Reopening and revision of a reconsidered determination or a
decision (Sec. 478.48)
IV. Collection of Information Requirements
V. Response to Comments
VI. Regulatory Impact Statement
VII. Federal Analysis
I. Background
In accordance with provisions of sections 1155, 1852, 1860D-4,
1869, and 1876 of the Act, and their implementing regulations, there
are multiple administrative appeal processes for Medicare fee-for-
service (Part A and Part B) claim, entitlement and certain premium
initial determinations; Medicare Advantage (Part C) and other
competitive health plan organization determinations; and Part D plan
sponsor coverage determinations and certain premium determinations. The
first, and in many instances a second, level of administrative appeal
are administered
[[Page 43792]]
by Medicare contractors, Part D plan sponsors, Medicare Advantage
organizations or Medicare plans, or by the SSA. For example, under
section 1869 of the Act, the Medicare claims appeal process involves
redeterminations conducted by the Medicare Administrative Contractors
(which are independent of the staff that made the initial
determination) followed by reconsiderations conducted by QICs. However,
all of the appeals discussed in this proposed regulation could be
appealed to the ALJs at OMHA if the amount in controversy requirement
and other requirements are met after these first and/or second levels
of appeal.
OMHA, a staff division within the Office of the Secretary of HHS,
administers the nationwide ALJ hearing program for Medicare claim,
organization and coverage determination, and entitlement and certain
premium appeals. If the amount in controversy and other filing
requirements are met, a hearing before an ALJ is available following a
QIO reconsidered determination under section 1155 of the Act; an SSA or
QIC reconsideration, or a request for QIC reconsideration for which a
decision is not issued timely and a party requests escalation of the
matter under section 1869(b)(1)(A) and (d) of the Act (Part A and Part
B appeals); an IRE reconsideration or QIO reconsidered determination
under sections 1876(c)(5)(B) or 1852(g)(5) of the Act (Part C and other
managed health plan appeals); or an IRE reconsideration under section
1860D-4(h) of the Act (Part D appeals). In addition, under current
regulations a review by an ALJ is available following a dismissal of a
request for reconsideration, if the amount in controversy and other
filing requirements are met.
OMHA provides Medicare beneficiaries and the providers and
suppliers that furnish items or services to Medicare beneficiaries, as
well as applicable plans, MAOs, and Medicaid State agencies with a fair
and impartial forum to address disagreements regarding: Medicare
coverage and payment determinations made by Medicare contractors, MAOs,
or Part D plan sponsors; and determinations related to Medicare
beneficiary eligibility and entitlement, Part B late enrollment
penalties, and IRMAAs, which apply to Medicare Part B and Part D
premiums, made by SSA. Further review of OMHA ALJ decisions, except
decisions affirming a dismissal of a request for reconsideration, is
available from the Medicare Appeals Council (Council) within the DAB, a
staff division within the Office of the Secretary of HHS. Judicial
review is then available for Council decisions in Federal courts, if
the amount in controversy and other requirements are met.
OMHA ALJs began adjudicating appeals in July 2005, based on section
931 of the MMA, which required the transfer of responsibility for the
ALJ hearing level of the Medicare claim and entitlement appeals process
from SSA to HHS. New rules at 42 CFR part 405, subpart I and subpart J
were also established to implement statutory changes to the Medicare
fee-for-service (Part A and Part B) appeals process made by BIPA in
2000 and the MMA in 2003. Among other things, these new rules addressed
appeals of reconsiderations made by QICs, which were created by BIPA
for the Part A and Part B programs. These rules also apply to appeals
of SSA reconsiderations. The statutory changes made by BIPA included a
90-day adjudication time frame for ALJs to adjudicate appeals of QIC
reconsiderations beginning on the date that a request for an ALJ
hearing is timely filed. The new part 405, subpart I rules were
initially proposed in the November 15, 2002 Federal Register (67 FR
69312) (2002 Proposed Rule) to implement BIPA, and were subsequently
implemented in an interim final rule with comment period, which also
set forth new provisions to implement the MMA, in the March 8, 2005
Federal Register (70 FR 11420) (2005 Interim Final Rule). Correcting
amendments to the 2005 Interim Final Rule were published in the June
30, 2005 Federal Register (70 FR 37700) (2005 Correcting Amendment I)
and in the August 26, 2005 Federal Register (70 FR 50214) (2005
Correcting Amendment II), and the final rule was published in the
December 9, 2009 Federal Register (74 FR 65296) (2009 Final Rule).
Subsequent revisions to part 405, subpart I to implement the
Strengthening Medicare and Repaying Taxpayers Act of 2012 (SMART Act,
Pub. L. 112-242) were published in the February 27, 2015 Federal
Register (80 FR 10611) (SMART Act Final Rule).
In addition to the part 405, subpart I rules, OMHA applies the
rules at 42 CFR part 478, subpart B to individuals' appeals of QIO
reconsidered determinations; part 422, subpart M to appeals of IRE
reconsiderations or QIO reconsidered determinations under the Medicare
Advantage (Part C) and other competitive health plan programs; and part
423, subpart U to appeals of IRE reconsiderations under the Medicare
prescription drug (Part D) program.
In recent years, the Medicare appeals process has experienced an
unprecedented and sustained increase in the number of appeals. At OMHA,
for example, the number of requests for an ALJ hearing or review
increased 1,222 percent, from fiscal year (FY) 2009 through FY 2014.
The increasing number of requests has strained OMHA's available
resources and resulted in delays for appellants to obtain hearings and
decisions.
Despite significant gains in OMHA ALJ productivity (in FY 2014,
each OMHA ALJ issued, on average, a record 1,048 decisions and an
additional 456 dismissals), and CMS and OMHA initiatives to address the
increasing number of appeals, the number of requests for an ALJ hearing
and requests for reviews of QIC and IRE dismissals continue to exceed
OMHA's capacity to adjudicate the requests. As of April 30, 2016, OMHA
had over 750,000 pending appeals, while OMHA's adjudication capacity
was 77,000 appeals per year, with an additional adjudication capacity
of 15,000 appeals per year expected by the end of Fiscal Year 2016.
HHS has a three-prong approach to addressing the increasing number
of appeals and the current backlog of claims waiting to be adjudicated
at OMHA: (1) Request new resources to invest at all levels of appeal to
increase adjudication capacity and implement new strategies to
alleviate the current backlog; (2) take administrative actions to
reduce the number of pending appeals and implement new strategies to
alleviate the current backlog ; and (3) propose legislative reforms
that provide additional funding and new authorities to address the
volume of appeals. In this notice of proposed rulemaking, HHS is
pursuing the three-prong approach by proposing rules that would expand
the pool of available OMHA adjudicators and improve the efficiency of
the appeals process by streamlining the processes so less time is spent
by adjudicators and parties on repetitive issues and procedural
matters.
II. General Provisions of the Proposed Regulations
A. Precedential Final Decisions of the Secretary
Council decisions are binding on the parties to that particular
appeal and are the final decisions of the Secretary from which judicial
review may be sought under section 205(g) of the Act, in accordance
with current Sec. Sec. 405.1130, 422.612(b), 423.2130, and 478.46(b).
As explained in the 2009 Final Rule (74 FR 65307 through 65308),
``binding'' indicates the parties are obligated to
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abide by the adjudicator's action or decision unless further recourse
is available and a party exercises that right. ``Final'' indicates that
no further administrative review of the decision is available and
judicial review may be immediately sought.
In 1999, the OIG issued a report entitled ``Medicare Administrative
Appeals--ALJ Hearing Process'' (OEI-04-97-00160) (Sept. 1999) (https://oig.hhs.gov/oei/reports/oei-04-97-00160.pdf). In that report, the OIG
noted that the DAB respondents voiced strong interest in having
precedent setting authority in the Medicare administrative appeals
process ``to clean-up inconsistencies in the appeals process.'' The OIG
recommended that such a case precedent system be established.
Pursuant to section 931(a) of the MMA, HHS and SSA developed a plan
for the transition of the ALJ hearing function for some types of
Medicare appeals from SSA to HHS, and addressed the feasibility of
precedential authority of DAB decisions. See Report to Congress: Plan
for the Transfer of Responsibility for Medicare Appeals (Mar. 2004)
(https://www.ssa.gov/legislation/medicare/medicare_appeal_transfer.pdf). HHS determined that at that time, it was
not feasible or appropriate to confer precedential authority on Council
decisions, but indicated that it would reevaluate the merits of
granting precedential authority to some or all Council decisions after
the BIPA and MMA changes to the appeals process were fully implemented.
BIPA and MMA changes to the appeals process have now been fully
implemented and we believe it is appropriate to propose that select
Council decisions be made precedential to increase consistency in
decisions at all levels of appeal for appellants. Proposed Sec.
401.109 would introduce precedential authority to the Medicare claim
and entitlement appeals process under part 405, subpart I; part 422,
subpart M; part 423, subparts M and U; and part 478, subpart B.
Proposed Sec. 401.109(a) would grant authority to the Chair of the DAB
to designate a final decision of the Secretary issued by the Council as
precedential. We believe this would provide appellants with a
consistent body of final decisions of the Secretary upon which they
could determine whether to seek appeals. It would also assist appeal
adjudicators at all levels of appeal by providing clear direction on
repetitive legal and policy questions, and in limited circumstances,
factual questions. In the limited circumstances in which a precedential
decision would apply to a factual question, the decision would be
binding where the relevant facts are the same and evidence is presented
that the underlying factual circumstances have not changed since the
Council issued the precedential final decision.
It is appropriate for the DAB Chair to have the role of designating
select Council decisions as precedential. The DAB Chair leads the DAB,
which was established in 1973. The DAB has wide jurisdiction over
disputes arising under many HHS programs and components, and has issued
precedential decisions for many years within several of its areas of
jurisdiction. (Examples of DAB jurisdiction may be found at 45 CFR part
16, 42 CFR part 498, 42 CFR part 426, and on the DAB's Web site at
www.hhs.gov/dab.) The Council has been housed within the DAB as an
organization since 1995 and is itself also under the leadership of the
DAB Chair. Thus, the DAB Chair brings both expertise in the Medicare
claims appeals over which the Council has jurisdiction and experience
from the DAB's precedential cases to carrying out the role of
designating Council decisions to be precedential. Moreover, having the
designation performed by the DAB Chair respects the continued
independence of the Council as an adjudicative body by allowing the DAB
to determine the effect of its own decisions. Limiting binding
precedential effect to selected decisions provides the necessary
discretion to designate as precedential those Council decisions in
which a significant legal or factual issue was fully developed on the
record and thoroughly analyzed. Designation might not be appropriate
where an issue was mentioned in the decision as relevant but was not
outcome determinative, and therefore may not have been as fully
developed as is necessary for precedential decisions or where the
issues addressed are not likely to have broad application beyond the
particular case.
To help ensure appellants and other stakeholders are aware of
Council decisions that are designated as precedential, we are proposing
that Sec. 401.109(b) would require notice of precedential decisions to
be published in the Federal Register, and the decisions themselves
would be made available to the public, with necessary precautions taken
to remove personally identifiable information that cannot be disclosed
without the individual's consent. Designated precedents would be posted
on an accessible Web site maintained by HHS. Decisions of the Council
would bind all lower-level decision-makers from the date that the
decisions are posted on the HHS Web site.
Proposed Sec. 401.109(c) would make these precedential decisions
binding on all CMS components, on all HHS components that adjudicate
matters under the jurisdiction of CMS, and on SSA to the extent that
SSA components adjudicate matters under the jurisdiction of CMS, in the
same manner as CMS Rulings under current Sec. 401.108. That means the
precedential decision would be binding on CMS and its contractors in
making initial determinations, redeterminations, and reconsiderations,
under part 405 subpart I, or equivalent determinations under parts 422
subpart M, 423 subparts M and U, and 478 subpart B; OMHA ALJs and, as
proposed in II.B below, attorney adjudicators; the Council in its
future decisions; and SSA to the extent that it adjudicates matters
under the jurisdiction of CMS. Individual determinations and decisions
by CMS contractors, OMHA ALJs, and the Council currently are not
precedential and have no binding effect on future initial
determinations (and equivalent determinations) or claims appeals. We
are not proposing to change the non-precedential status and non-binding
effect on future initial determinations (and equivalent determinations)
or claim appeals of any determinations or decisions except as to
Council decisions designated as precedential by the DAB Chair.
Proposed Sec. 401.109(d) would specify the scope of the
precedential effect of a Council decision designated by the DAB Chair.
The Council's legal analysis and interpretation of an authority or
provision that is binding (see, for example Sec. Sec. 405.1060 and
405.1063) or owed substantial deference (see, for example Sec.
405.1062) would be binding in future determinations and appeals in
which the same authority or provision is applied and is still in
effect. However, if CMS revises the authority or provision that is the
subject of a precedential decision, the Council's legal analysis and
interpretation would not be binding on claims or other disputes to
which the revised authority or provision applies. For example, if a
Council decision designated as precedential by the DAB Chair interprets
a CMS manual instruction, that interpretation would be binding on
pending and future appeals and initial determinations to which that
manual instruction applies. However, CMS would be free to follow its
normal internal process to revise the manual instruction at issue. Once
the revised instruction is issued through the CMS process, the revised
instruction would
[[Page 43794]]
apply to making initial determinations on all claims thereafter. This
would help ensure that CMS continues to have the ultimate authority to
administer the Medicare program and promulgate regulations, and issue
sub-regulatory guidance and policies on Medicare coverage and payment.
If the decision is designated as precedential by the DAB Chair,
proposed Sec. 401.109(d) would also make the Council's findings of
fact binding in future determinations and appeals that involve the same
parties and evidence. For example, if a precedential Council decision
made findings of fact related to the issue of whether an item qualified
as durable medical equipment and the same issue was in dispute in
another appeal filed by the same party, and that party submitted the
same evidence to support its assertion, the findings of fact in the
precedential Council decision would be binding. However, we note that
many claim appeals turn on evidence of a beneficiary's condition or
care at the time discrete items or services are furnished, and
therefore proposed Sec. 401.109 is unlikely to apply to findings of
fact in these appeals.
In addition, consistent with proposed Sec. 401.109, we are
proposing at Sec. 405.968(b)(1) to add precedential decisions
designated by the Chair of the Departmental Appeals Board as an
authority that is binding on the QIC. We are also proposing at
Sec. Sec. 405.1063 and 423.2063, which currently cover the
applicability of laws, regulations, and CMS Rulings, to add new
paragraph (c) to the sections to provide that precedential decisions
designated by the Chair of the Departmental Appeals Board in accordance
with Sec. 401.109 are binding on all CMS components, all HHS
components that adjudicate matters under the jurisdiction of CMS, and
on the Social Security Administration to the extent that components of
the Social Security Administration adjudicate matters under the
jurisdiction of CMS. Finally, we are proposing to add precedential
decisions to the titles of Sec. Sec. 405.1063 and 423.2063 to reflect
the additional topic covered by proposed paragraph (c).
We are inviting public comments on these proposals. If you choose
to comment on the proposals in this section, please include the caption
``Precedential final decisions of the Secretary'' at the beginning of
your comment.
B. Attorney Adjudicators
Sections 1155, 1852(g)(5), 1860D-4(h), 1869(b)(1)(A), and
1876(c)(5)(B) provide a right to a hearing to the same extent as
provided in section 205(b) by the HHS Secretary for certain appealable
decisions by Medicare contractors or SSA, when the amount in
controversy and other filing requirements are met. Hearings under these
statutory provisions are conducted by OMHA ALJs with delegated
authority from the HHS Secretary, in accordance with these sections and
the APA.
Under current Sec. Sec. 405.1038 and 423.2038, OMHA ALJs are also
responsible for a portion of the appeals workload that does not require
a hearing because a request for an ALJ hearing may also be addressed
without conducting a hearing. For example, under Sec. Sec. 405.1038
and 4423.2038, if the evidence in the hearing record supports a finding
in favor of the appellant(s) on every issue, or if all parties agree in
writing that they do not wish to appear before the ALJ at a hearing,
the ALJ may issue a decision on the record without holding a hearing.
Under current Sec. Sec. 405.1052(a)(1) and 423.2052(a)(1), OMHA ALJs
must also address a large number of requests to withdraw requests for
ALJ hearings, which appellants often file pursuant to litigation
settlements, law enforcement actions, and administrative agreements in
which they agree to withdraw appeals and not seek further appeals of
resolved claims. In addition, pursuant to Sec. Sec. 405.1004 and
423.2004, OMHA ALJs review whether a QIC or IRE dismissal was in error.
Under these sections, the ALJ reviews the dismissal, but no hearing is
required. In FY 2015, OMHA ALJs addressed approximately 370 requests to
review whether a QIC or IRE dismissal was in error. Also adding to the
ALJs' workload are remands to Medicare contractors for information that
can only be provided by CMS or its contractors under current Sec. Sec.
405.1034(a) and 423.2034(a), and for further case development or
information at the direction of the Council. Staff may identify the
basis for these remands before an appeal is assigned to an ALJ and a
remand order is prepared, but an ALJ must review the appeal and issue
the remand order, taking the ALJ's time and attention away from
hearings and making decision on the merits of appeals.
Under section 1869(d) of the Act, an ALJ must conduct and conclude
a hearing on a decision of a QIC under subsection (c). Subsection (c)
of section 1869 of the Act involves the conduct of reconsiderations by
QICs. We believe that the statute does not require the action to be
taken by an ALJ in cases where there is no QIC reconsideration (for
example, where the QIC has issued a dismissal), or in cases of a remand
or a withdrawal of a request for an ALJ hearing, and therefore the
findings of fact and conclusions of law need not be rendered. ALJ
hearings are ideally suited to obtain testimony and other evidence, and
hear arguments related to the merits of a claim or other determination
on appeal. ALJs are highly qualified to conduct those hearings and make
findings of fact and conclusions of law to render a decision in the
more complex records presented with a mix of documentary and
testimonial evidence. However, well-trained attorneys can perform a
review of the administrative record and more efficiently draft the
appropriate order for certain actions, such as issuing dismissals based
on an appellant's withdrawal of a request for an ALJ hearing, remanding
appeals for information or at the direction of the Council, and
conducting reviews of QIC and IRE dismissals.
In addition, current Sec. Sec. 405.1038 and 423.2038 provide
mechanisms for deciding cases without an oral hearing, based on the
written record. Cases may be decided without an oral hearing when the
record supports a finding in favor of the appellant(s) on every issue;
all of the parties have waived the oral hearing in writing; or the
appellant lives outside of the United States and did not inform the ALJ
that he or she wishes to appear, and there are no other parties who
wish to appear. In these circumstances, the need for an experienced
adjudicator knowledgeable in Medicare coverage and payment law
continues, and well-trained attorneys can review the record, identify
the issues, and make the necessary findings of fact and conclusions of
law when the regulations do not require a hearing to issue a decision
in the appealed matter.
To enable OMHA to manage requests for an ALJ hearing and requests
for reviews of QIC and IRE dismissals in a more timely manner and
increase service to appellants, while preserving access to a hearing
before an ALJ in accordance with the statutes, we are proposing to
revise rules throughout part 405, subparts I and J; part 422, subpart
M; part 423, subparts M and U; and part 478, subpart B, to provide
authority that would allow attorney adjudicators to issue decisions
when a decision can be issued without an ALJ conducting a hearing under
the regulations, dismissals when an appellant withdraws his or her
request for an ALJ hearing, and remands for information that can only
be provided by CMS or its contractors or at the direction of the
Council; as well as to conduct reviews of QIC and IRE dismissals. We
also are proposing to revise the rules so that decisions and
[[Page 43795]]
dismissals issued by attorney adjudicators may be reopened and/or
appealed in the same manner as equivalent decisions and dismissals
issued by ALJs. Allowing attorney adjudicators to issue decisions,
dismissals, and remands as described above, and to conduct reviews of
QIC and IRE dismissals would expand the pool of OMHA adjudicators and
allow ALJs to focus on cases going to a hearing, while still providing
appellants with quality reviews and decisions, dismissals, and remands.
In addition, the rights associated with an appeal adjudicated by an ALJ
would extend to any appeal adjudicated by an attorney adjudicator,
including any applicable adjudication time frame, escalation option,
and/or right of appeal to the Council.
In addition, we note that even if an attorney adjudicator was
assigned to adjudicate a request for an ALJ hearing, that hearing
request still could be reassigned to an ALJ for an oral hearing if the
attorney adjudicator determined that a hearing could be necessary to
render a decision. For example, if the parties waived their rights to
an oral hearing in writing, allowing a decision to be issued without
conducting an oral hearing in accordance with current Sec. Sec.
405.1038(b)(1) or 423.2038(b)(1), but the attorney adjudicator believed
testimony by the appellant or another party would be necessary to
decide the appeal, the attorney adjudicator would refer the appeal to
an ALJ to determine whether conducting an oral hearing would be
necessary to decide the appeal regardless of the waivers, pursuant to
current Sec. Sec. 405.1036(b)(3) or 423.2036(b)(3). We also note that
parties to a decision that is issued without an ALJ conducting an oral
hearing pursuant to current Sec. Sec. 405.1038(a) or 423.2038(a) (that
is, the decision is favorable to the appellant on every issue and
therefore may be issued based on the record alone) continue to have a
right to a hearing and a right to examine the evidence on which the
decision is based and may pursue that right by requesting a review of
the decision by the Council, which can remand the case for an ALJ to
conduct a hearing and issue a new decision.
To implement this proposal, we are proposing to revise provisions
throughout part 405 subpart I, part 422 subpart M, part 423 subparts M
and U, and part 478 subpart U, as detailed in proposed revisions to
specific sections, in section III of this proposed rule, below. In
addition, we are proposing to define an attorney adjudicator in Sec.
405.902, which provides definitions that apply to part 405 subpart I.
We are proposing to define an ``attorney adjudicator'' in Sec. 405.902
as a licensed attorney employed by OMHA with knowledge of Medicare
coverage and payment laws and guidance. In addition, we are proposing
to indicate in Sec. 405.902 that the attorney adjudicator is
authorized to take the actions provided for in subpart I on requests
for ALJ hearing and requests for reviews of QIC dismissals. These
proposals would provide the public with an understanding of the
attorney adjudicator's qualifications and scope of authority, and we
also note that attorney adjudicators would receive the same training as
OMHA ALJs.
We are inviting public comments on these proposals. If you choose
to comment on the proposals in this section, please include the caption
``Attorney Adjudicators'' at the beginning of your comment.
C. Application of 405 Rules to Other Parts
Current Sec. 422.562(d) states that unless subpart M regarding
grievances, organization determinations and appeals under the Medicare
Advantage program provides otherwise, the regulations found in part 405
apply under subpart M to the extent appropriate. In addition, current
Sec. 422.608, which is a section within subpart M, provides that the
regulations under part 405 regarding Council review apply to the
subpart to the extent that they are appropriate.
Similar to current Sec. 422.562(d), Sec. 478.40(c) indicates that
the part 405 regulations apply to hearings and appeals under subpart B
of part 478 regarding QIO reconsiderations and appeals, unless they are
inconsistent with specific provisions in subpart B. Thus, the part 405
rules are used, to the extent appropriate, for administrative review
and hearing procedures in the absence of specific provisions related to
administrative reviews and hearing procedures in part 422, subpart M;
and part 478, subpart B, respectively. These general references to part
405 are often helpful in filling in gaps in procedural rules when there
is no rule on point in the respective part. However, there has been
confusion on the application of part 405 rules when a part 405 rule
implements a specific statutory provision that is not in the
authorizing statute for the referring subpart and HHS has not adopted a
similar policy for the referring subpart in its discretion to
administer the Medicare Advantage, QIO, and cost plan appeals programs.
For example, certain procedures and provisions of section 1869 of the
Act (governing certain determinations and appeals under Medicare Part A
and Part B) that are implemented in part 405, subpart I are different
than or not addressed in sections 1155 (providing for reconsiderations
and appeals of QIO determinations), 1852(g) (providing for appeals of
MA organization determinations), and 1876 (providing for appeals of
organization determinations made by section 1876 health maintenance
organizations (HMOs) and competitive medical plans (CMPs). Section 1869
of the Act provides for, among other things, redeterminations of
certain initial determinations, QIC reconsiderations following
redeterminations or expedited determinations; ALJ hearings and
decisions following a QIC reconsideration; DAB review following ALJ
decisions; specific time frames in which to conduct the respective
adjudications; and, at certain appeal levels, the option to escalate
appeals to the next level of appeal if the adjudication time frames are
not met. In addition, section 1869(b)(3) of the Act does not permit
providers and suppliers to introduce evidence in an appeal brought
under section 1869 of the Act after the QIC reconsideration, unless
there is good cause that precluded the introduction of the evidence at
or before the QIC reconsideration.
In contrast, sections 1852(g)(5) of the Act and 1876(c)(5)(B) of
the Act incorporate some, but not all, of the provisions of section
1869 of the Act, and add certain requirements, such as making the MAO,
HMO, or CMP a party to an ALJ hearing. For example, sections 1852(g)(5)
and 1876(c)(5)(B) of the Act specifically incorporate section
1869(b)(1)(E)(iii) of the Act to align the amount in controversy
requirements for an ALJ hearing and judicial review among the three
sections. However, sections 1852(g) and 1876(c)(5)(B) do not
incorporate adjudication time frames and escalation provisions, or the
limitation on new evidence provision of section 1869(b)(3) of the Act.
Additionally, section 1155 of the Act provides for an individual's
right to appeal certain QIO reconsidered determinations made under
section 1154 of the Act directly to an ALJ for hearing. However,
section 1155 of the Act does not reference section 1869 of the Act or
otherwise establish an adjudication time frame, and provides for a
different amount in controversy requirement for an ALJ hearing.
Despite these statutory distinctions, HHS has established similar
procedures by regulation to the extent practicable, when not addressed
by statute. For example, section 1860D-4(h) of the Act, which addresses
appeals of coverage
[[Page 43796]]
determinations under Medicare Part D, incorporates paragraphs (4) and
(5) of section 1852(g) of the Act. As discussed above, section 1852(g)
does not incorporate adjudication time frames from section 1869 of the
Act or otherwise establish such time frames. However, through
rulemaking for Part D coverage determination appeals, HHS has adopted a
90-day adjudication time frame for standard requests for an ALJ hearing
and requests for Council review of an ALJ decision, as well as a 10-day
adjudication time frame when the criteria for an expedited hearing or
review are met.
To clarify the application of the part 405 rules, we are proposing
revisions to parts 422 and 478. Proposed Sec. Sec. 422.562(d) and
422.608 would provide that the part 405 rules do not apply when the
part 405 rule implements a statutory provision that is not also
applicable to section 1852 of the Act. Similarly, proposed Sec.
478.40(c) would provide that the part 405 rules do not apply when the
part 405 rule implements a statutory provision that is not also
applicable to section 1155 of the Act. In addition, proposed Sec.
478.40(c) removes language that equates an initial determination and
reconsidered determination made by a QIO to contractor initial
determinations and reconsidered determinations under part 405 because
that language has caused confusion with provisions that are specific to
part 405 and QIC reconsiderations, and it is not necessary to apply the
remaining part 405, subpart I procedural rules in part 478, subpart B
proceedings. In addition to clarifying the application of part 405
rules to other parts, these revisions would help ensure that statutory
provisions that are specific to certain Medicare appeals are not
applied to other appeals without HHS first determining, through
rulemaking, whether it would be appropriate to apply a provision and
how best to tailor aligning policies for those other appeals.
We are inviting public comments on these proposals. If you choose
to comment on the proposals in this section, please include the caption
``Application of part 405 rules to other parts'' at the beginning of
your comment.
D. OMHA References
When the 2005 Interim Final Rule was published in March 2005,
implementing the part 405, subpart I rules, OMHA was not yet in
operation. Further, processes and procedures were being established
under the part 405 subpart I rules, with new CMS contractors and the
newly transitioned ALJ hearing function. Since that time, OMHA and CMS
and its contractors have developed operating arrangements to help
ensure appeals flow between CMS contractors and OMHA, and that appeal
instructions for appellants provide clear direction on how and where to
file requests for hearings and reviews. However, many of the current
rules for the ALJ hearing program that OMHA administers reflect the
transition that was occurring at the time of the 2005 Interim Final
Rule, and OMHA is not mentioned in the regulation text.
To provide clarity to the public on the role of OMHA in
administering the ALJ hearing program, and to clearly identify where
requests and other filings should be directed, we are proposing to
define OMHA in Sec. 405.902 as the Office of Medicare Hearings and
Appeals within the U.S. Department of Health and Human Services, which
administers the ALJ hearing process in accordance with section
1869(b)(1) of the Act. We are also proposing to amend rules throughout
part 405, subparts I and J; part 422, subpart M; part 423, subparts M
and U; and part 478, subpart B to reference OMHA or an OMHA office, in
place of current references to an unspecified entity, ALJs, and ALJ
hearing offices, when a reference to OMHA or an OMHA office provides a
clearer explanation of a topic. To implement this proposal, we are
proposing to revise provisions throughout part 405 subparts I and J,
part 422 subpart M, part 423 subparts M and U, and part 478 subpart U,
as detailed in proposed revisions to specific sections, in section III
of this proposed rule, below.
We are inviting public comments on these proposals. If you choose
to comment on the proposals in this section, please include the caption
``OMHA references'' at the beginning of your comment.
E. Medicare Appeals Council References
The Council is currently referred to as the ``MAC'' throughout
current part 405, subpart I; part 422, subpart M; and part 423,
subparts M and U. This reference has caused confusion in recent years
with the transition from Fiscal Intermediaries and Carriers, to
Medicare administrative contractors--for which the acronym ``MAC'' is
also commonly used--to process claims and make initial determinations
and redeterminations in the Medicare Part A and Part B programs. In
addition, current Sec. Sec. 422.618 and 422.619 reference the Medicare
Appeals Council but use ``Board'' as the shortened reference, and part
478, subpart B, references the DAB as the reviewing entity for appeals
of ALJ decisions and dismissals but the Council is the entity that
conducts reviews of ALJ decisions and dismissals, and issues final
decisions of the Secretary for Medicare appeals under part 478, subpart
B.
To address potential confusion with references to Medicare
administrative contractors and align references to the Council as the
reviewing entity for appeals of ALJ decisions and dismissals throughout
part 405, subpart I; part 422, subpart M; and part 423, subparts M and
U, we are proposing to amend the following rules to replace ``MAC'' or
``Board'' with ``Council'': Sec. Sec. 405.902, 405.904, 405.906,
405.908, 405.910, 405.926, 405.980, 405.982, 405.984, 405.990,
405.1026, 405.1036, 405.1037, 405.1042, 405.1046, 405.1048, 405.1050,
405.1052, 405.1054, 405.1060, 405.1063, 405.1062, 405.1100, 405.1102,
405.1104 (as re-designated and revised as proposed Sec. 405.1016(e)-
(f)), 405.1106, 405.1108, 405.1110, 405.1112, 405.1114, 405.1116,
405.1118, 405.1120, 405.1122, 405.1124, 405.1126, 405.1128, 405.1130,
405.1132, 405.1134, 405.1136, 405.1138, 405.1140, 422.561, 422.562,
422.608, 422.612, 422.616, 422.618, 422.619, 422.622, 422.626, 423.560,
423.562, 423.1968, 423.1974, 423.1976, 423.1978, 423.1980, 423.1982,
423.1984, 423.1990, 423.2026, 423.2036, 423.2042, 423.2046, 423.2048,
423.2050, 423.2052, 423.2054, 423.2062, 423.2063, 423.2100, 423.2102,
423.2106, 423.2108, 423.2110, 423.2112, 423.2114, 423.2116, 423.2118,
423.2120, 423.2122, 423.2124, 423.2126, 423.2128, 423.2130, 423.2134,
423.2136, 423.2138, and 423.2140.
In addition, to align references to the Council as the reviewing
entity for appeals of ALJ decisions and dismissals in part 478, subpart
B, we are proposing to amend Sec. Sec. 478.46 and 478.48 to replace
``Departmental Appeals Board'' and ``DAB,'' with ``Medicare Appeals
Council'' and ``Council''.
We are inviting public comments on these proposals. If you choose
to comment on the proposals in this section, please include the caption
``Medicare Appeals Council references'' at the beginning of your
comment.
III. Specific Provisions of the Proposed Rule
A. Provisions of Part 405, Subpart I and Part 423, Subparts M and U
1. Overview
Part 405, subpart I and part 423, subpart U contain detailed
procedures for requesting and adjudicating a request for an ALJ
hearing, and a request for a review of a QIC or IRE dismissal. Part
423, subpart U provisions were proposed in the March 17, 2008 Federal
[[Page 43797]]
Register (73 FR 14342) and made final in the December 9, 2009 Federal
Register (74 FR 65340), and generally follow the part 405, subpart I
procedures. In this proposed rule, we generally discuss proposals
related to part 405, subpart I, and then whether any aligning revisions
to part 423, subpart U, are proposed, unless a provision is specific to
Part 405 and there is no corresponding part 423 provision.
2. General Provisions, Reconsiderations, Reopenings, and Expedited
Access to Judicial Review
a. Part 423, Subpart M General Provisions (Sec. 423.562)
Current Sec. 423.562(b)(4) lists the appeal rights of a Part D
plan enrollee, if the enrollee is dissatisfied with any part of a
coverage determination. Specifically, paragraph (b)(4)(v) describes the
right to request Council review of the ALJ's hearing decision if the
ALJ affirms the IRE's adverse coverage determination in whole or in
part, and paragraph (b)(4)(vi) describes the right to judicial review
of the hearing decision if the Council affirms the ALJ's adverse
coverage determination in whole or in part, and the amount in
controversy requirements are met. We are proposing to revise paragraph
(b)(4)(v) to insert ``or attorney adjudicator'' after each instance of
``the ALJ.'' This proposal is necessary to implement the proposal to
allow attorneys to adjudicate requests for an ALJ hearing when no
hearing is conducted as proposed in section II.B above, by stating the
right to request Council review of an attorney adjudicator decision
that affirms the IRE's adverse coverage determination. We also are
proposing to remove ``hearing'' before ``decision'' in paragraph
(b)(4)(v) to reflect that an attorney adjudicator issues decisions
without conducting a hearing, and an ALJ may issue a decision without
conducting a hearing.
In paragraph (b)(4)(vi), we are proposing to remove ``ALJ's'' and
insert ``ALJ's or attorney adjudicator's'' in its place to implement
the proposal to allow attorneys to adjudicate requests for an ALJ
hearing when no hearing is conducted as proposed in section II.B above,
by including an attorney adjudicator's decision as a decision that may
be affirmed by the Council. We also are proposing to remove ``hearing''
before ``decision'' in paragraph (b)(4)(vi) because while the Council
may conduct a hearing, Council decisions are generally issued without
conducting a hearing, and the decision of the Council is subject to
judicial review.
We are inviting public comments on these proposals. If you choose
to comment on the proposals in this section, please include the caption
``Part 423, subpart M general provisions'' at the beginning of your
comment.
b. Part 423, Subpart U Title and Scope (Sec. 423.1968)
The current heading of part 423, subpart U references ALJ hearings
but does not reference decisions. We are proposing to revise the
heading by replacing ``ALJ Hearings'' with ``ALJ hearings and ALJ and
attorney adjudicator decisions'' to reflect that subpart U covers
decisions by ALJs and attorney adjudicators, as proposed in section
II.B above.
Current Sec. 423.1968 explains the scope of the requirements in
subpart U. We are proposing at Sec. 423.1968 to expand the scope of
subpart U to include actions by attorney adjudicators, as proposed in
section II.B above. Specifically, we are proposing at Sec. 423.1968(a)
to add that subpart U sets forth requirements relating to attorney
adjudicators with respect to reopenings; at Sec. 423.1968(b) to add
that subpart U sets forth requirements relating to ALJ decisions and
decisions of attorney adjudicators if no hearing is conducted; and at
Sec. 423.1968(d) to add that subpart U sets forth the requirements
relating to Part D enrollees' rights with respect to ALJ hearings and
ALJ or attorney adjudicator reviews. These changes would be necessary
to accurately describe the scope of the revised provisions of subpart U
to implement the attorney adjudicator proposal discussed in section
II.B above.
We are inviting public comments on these proposals. If you choose
to comment on the proposals in this section, please include the caption
``Part 423, subpart U title and scope'' at the beginning of your
comment.
c. Medicare Initial Determinations, Redeterminations and Appeals
General Description (Sec. 405.904)
Section 405.904(a) provides a general overview of the entitlement
and claim appeals process to which part 405, subpart I applies. Current
paragraphs (a)(1) and (a)(2) provide that if a beneficiary obtains a
hearing before an ALJ and is dissatisfied with the decision of the ALJ,
the beneficiary may request that the Council review the case. To
provide for the possibility that a decision may be issued without
conducting a hearing by an ALJ, as permitted under current rules, or an
attorney adjudicator, as proposed in II.B above, we are proposing to
add language in paragraphs (a)(1) and (a)(2) to provide that if the
beneficiary is dissatisfied with the decision of an ALJ or attorney
adjudicator when no hearing is conducted, the beneficiary may request
that the Council review the case. This proposal would provide a
comprehensive overview of the entitlement and claim appeals process,
with information on the potential for and right to appeal decisions by
ALJs when no hearing is conducted, and the right to appeal decisions by
attorney adjudicators, if the attorney adjudicator proposals are made
final.
We are inviting public comments on this proposal. If you choose to
comment on the proposal in this section, please include the caption
``Medicare initial determinations, redeterminations and appeals general
description'' at the beginning of your comment.
d. Parties to the Initial Determinations, Redeterminations,
Reconsiderations, Proceedings on a Request for Hearing, and Council
Review (Sec. 405.906)
Current Sec. 405.906 discusses parties to the appeals process and
subsection (b) currently addresses parties to the redetermination,
reconsideration, hearing and MAC. We are proposing in the paragraph
heading and introductory text to subsection (b) to replace the phrases
``hearing and MAC'' and ``hearing, and MAC review,'' respectively, with
``proceedings on a request for hearing, and Council review'' because,
absent an assignment of appeal rights, the parties are parties to all
of the proceedings on a request for hearing, including the hearing if
one is conducted, and they are parties to the Council's review.
We are inviting public comments on this proposal. If you choose to
comment on the proposal in this section, please include the caption
``Parties to the initial determinations, redeterminations,
reconsiderations, hearings, and reviews'' at the beginning of your
comment.
e. Medicaid State Agencies (Sec. 405.908)
Current Sec. 405.908 discusses the role of Medicaid State agencies
in the appeals process and states that if a State agency files a
request for redetermination, it may retain party status at the QIC,
ALJ, MAC and judicial review levels. We are proposing to replace
``ALJ'' with ``OMHA'' to provide that the State agency has party status
regardless of the adjudicator assigned to the State agency's request
for an ALJ hearing or request for review of a QIC dismissal at the OMHA
level of review, as attorney adjudicators may issue decisions on
[[Page 43798]]
requests for hearing and adjudicate requests for reviews of QIC
dismissals, as proposed in section II.B above.
We are inviting public comments on this proposal. If you choose to
comment on the proposal in this section, please include the caption
``Medicaid State agencies'' at the beginning of your comment.
f. Appointed Representatives (Sec. 405.910)
The 2002 Proposed Rule (67 FR 69318 through 69319) explained that
the Sec. 405.910 requirements for a valid appointment of a
representative are necessary to help ensure that adjudicators are
sharing and disseminating confidential information with the appropriate
individuals. The 2005 Interim Final Rule (70 FR 11428 through 11431)
adopted a general requirement to include a beneficiary's health
insurance claim number (HICN) for a valid appointment of a
representative in Sec. 405.910(c)(5). The SMART Act Final Rule (80 FR
10614, 10617) revised Sec. 405.910(c)(5) to explicitly limit the
requirement to include a beneficiary's HICN to instances in which the
beneficiary is the party appointing a representative. However, the
Medicare manual provision for completing a valid appointment of
representative (Medicare Claims Processing Manual (Internet-Only Manual
100-4), chapter 29, Sec. 270.1.2) details the requirements for an
appointment of representation to contain a unique identifier of the
party being represented. Specifically, if the party being represented
is the beneficiary, the Medicare number must be provided, and if the
party being represented is a provider or supplier, the National
Provider Identifier (NPI) number should be provided. Additionally, the
official form for executing a valid appointment of representative (form
CMS-1696, available at https://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/Downloads/CMS1696.pdf) provides a blank space for the party to
include a Medicare or NPI number. To assist adjudicators in sharing and
disseminating confidential information only with appropriate
individuals, we are proposing to revise Sec. 405.910(c)(5) to add a
requirement to include the Medicare NPI of the provider or supplier
that furnished the item or service when the provider or supplier is the
party appointing a representative. We are retaining the requirement to
identify the beneficiary's Medicare HICN when the beneficiary is the
party appointing a representative.
Current Sec. 405.910 also addresses defective appointments, and
delegations and revocations of appointments. However, there has been
confusion on the effects on the adjudication of an appeal when a
defective appointment must be addressed, or when an adjudicator is not
timely informed of a delegation or revocation of an appointment. To
address the effect of a defective appointment on the adjudication of an
appeal to which an adjudication time frame applies, we are proposing to
add Sec. 405.910(d)(3), which would extend an applicable adjudication
time frame from the later of (1) the date that a defective appointment
of representative was filed or (2) the date the current appeal request
was filed by the prospective appointed representative, to the date that
the defect in the appointment was cured or the party notifies the
adjudicator that he or she will proceed with the appeal without a
representative. We are proposing this revision because, in accordance
with current Sec. 405.910(d)(1) and (d)(2), a prospective appointed
representative lacks the authority to act on behalf of a party and is
not entitled to obtain or receive any information related to the
appeal. Thus, contact with the party may be necessary to obtain missing
information from the appointment, which may delay adjudicating the
appeal until the appointment is cured or the party decides to proceed
with the appeal without a representative. However, we are proposing
that if the request was filed by a prospective appointed
representative, the request would be considered filed for the purpose
of determining timeliness of the request, even if the individual is not
the appointed representative after the appointment is cured, or the
party decides to proceed with the appeal without a representative.
We are also proposing at Sec. 405.910(f)(1) to replace ``ALJ
level'' with ``OMHA level'' so there is no confusion that proceedings
at the OMHA level are considered proceedings before the Secretary for
purposes of appointed representative fees, regardless of whether the
case is assigned to an ALJ or attorney adjudicator.
Current Sec. 405.910(i)(2) and (i)(3) provide that if an appeal
involves an appointed representative, an ALJ sends notices of actions
or appeal decisions, and requests for information or evidence regarding
a claim that is appealed to the appointed representative. We are
proposing to insert ``or attorney adjudicator'' after ``ALJ'' in Sec.
405.910(i)(2) and (i)(3). This proposal would provide that attorney
adjudicators (as proposed in section II.B above), like an ALJ under the
current provisions, would send notices of actions or appeal decisions,
and requests for information or evidence regarding a claim that is
appealed to the appointed representative.
A representative and/or the represented party is responsible for
keeping the adjudicator of a pending appeal current on the status of
the representative. In practice, sometimes adjudicators are not
informed of a delegation or revocation of an appointment of
representative that has been filed for an appeal, which results in
confusion and potentially duplicative or unnecessary proceedings. We
are proposing to revise Sec. 405.910(l)(2) (which, as described later,
we are proposing to re-designate as (l)(1)(ii)) to add that a
delegation is not effective until the adjudicator receives a copy of
the party's written acceptance of the delegation, unless the
representative and designee are attorneys in the same law firm or
organization, in which case the written notice to the party of the
delegation may be submitted if the acceptance is not obtained from the
party. This proposed revision would emphasize the importance of keeping
adjudicators current on the status of the representative and also state
the effects of failing to do so. Proposed Sec. 405.910(l)(2) also
serves to assist adjudicators in sharing and disseminating confidential
information only with appropriate individuals, and to provide
adjudicators with appropriate contact information for scheduling
purposes. To accommodate proposed paragraph (l)(2), current paragraph
(l), except for the title of the paragraph, would be re-designated as
paragraph (l)(1), and the current subparagraphs would also be re-
designated accordingly. In addition, we are proposing to add a missing
``by'' in current paragraph (l)(1)(ii) (re-designated as (l)(1)(i)) of
Sec. 405.910 to indicate that a designee accepts to be obligated
``by'' and comply with the requirements of representation. We are also
proposing to revise language in current paragraph (l)(2) (re-designated
as (1)(l)(ii)) of Sec. 405.910 to clarify that ``this signed
statement'' refers to the ``written statement signed by the party,''
and the written statement signed by the party is not required when the
appointed representative and designee are attorneys in the same law
firm or organization and the notice of intent to delegate under
paragraph (l)(1)(i) indicates that fact. To further emphasize the
importance of keeping adjudicators current on the status of the
representative and clarify the effects of failing to do so, we are also
proposing
[[Page 43799]]
to add Sec. 405.910(l)(3) and (m)(4) that a party's or
representative's failure to notify the adjudicator that an appointment
of representative has been delegated or revoked, respectively, is not
good cause for missing a deadline or not appearing at a hearing.
We are not proposing any changes for part 423, subpart U because it
does not have a corresponding provision for representative
appointments.
We are inviting public comments on these proposals. If you choose
to comment on the proposals in this section, please include the caption
``Appointed representatives'' at the beginning of your comment.
g. Actions That Are Not Initial Determinations (Sec. 405.926)
Current Sec. 405.926(l) provides that an ALJ's decision to reopen
or not to reopen a decision is not an initial determination, and in
accordance with the introductory language of Sec. 405.926, is
therefore not appealable under subpart I. In section III.A.2.l below,
we are proposing to revise the reopening rules to provide that attorney
adjudicators would have the authority to reopen their decisions to the
same extent that ALJs may reopen their decisions under the current
provisions. We are proposing to insert ``or attorney adjudicator's''
after ``ALJ's'' in Sec. 405.926(l) to provide that the attorney
adjudicator's decision to reopen a decision also is an action that is
not an initial determination and therefore not an appealable action
under subpart I.
Current Sec. 405.926(m) provides that a determination that CMS or
its contractors may participate in or act as parties in an ALJ hearing
is not an initial determination, and in accordance with the
introductory language of Sec. 405.926, is therefore not appealable
under subpart I. As explained in section III.A.3.f below, we are
proposing to revise Sec. 405.1010, which currently discusses when CMS
or a contractor may participate in an ALJ hearing. As explained in the
proposal to revise Sec. 405.1010, CMS or a contractor may elect to
participate in the proceedings on a request for an ALJ hearing for
which no hearing is conducted, in addition to participating in an ALJ
hearing as a non-party participant. To align with our proposed revision
to Sec. 405.1010, we are proposing to revise Sec. 405.926(m) to
indicate that CMS or its contractors may participate in the full scope
of the proceedings on a request for an ALJ hearing, including the
hearing, by replacing ``participate in or act as parties in an ALJ
hearing,'' with ``participate in the proceedings on a request for an
ALJ hearing or act as parties in an ALJ hearing.''
We are inviting public comments on these proposals. If you choose
to comment on the proposals in this section, please include the caption
``Actions that are not initial determinations'' at the beginning of
your comment.
h. Notice of a Redetermination (Sec. 405.956)
Current Sec. 405.956(b)(8) requires that the notice of a
redetermination include a statement that evidence not submitted to the
QIC is not considered at an ALJ hearing or further appeal, unless the
appellant demonstrates good cause as to why that evidence was not
provided previously. We are proposing to remove ``an ALJ hearing'' and
add ``the OMHA level'' in its place so that the notice of a
redetermination is clear that, absent good cause and subject to the
exception in Sec. 405.956(d) for beneficiaries not represented by a
provider or supplier, evidence that was not submitted to the QIC is not
considered by an ALJ or an attorney adjudicator, as defined in Section
II.B above.
We are inviting public comments on this proposal. If you choose to
comment on the proposal in this section, please include the caption
``Notice of a redetermination'' at the beginning of your comment.
i. Time Frame for Making a Reconsideration Following a Contractor
Redetermination, Withdrawal or Dismissal of a Request for
Reconsideration, and Reconsideration (Sec. Sec. 405.970, 405.972, and
405.974)
As discussed in the 2005 Interim Final Rule (70 FR 11444 through
11445) and the 2009 Final Rule (74 FR 65311 through 65312), HHS adopted
a policy of providing for one level of administrative review of a
dismissal of a request for appeal. As a result, an adjudicator's
decision or dismissal when reviewing a dismissal action issued at the
previous level is binding and not subject to further review. The policy
balances a party's need for review and the need for administrative
finality. The policy is embodied in the rules relating to reviews of
dismissals at the next adjudicative level in current Sec. Sec.
405.972(e), 405.974(b)(3), 405.1004(c), 405.1102(c), 405.1108(b), and
405.1116.
At the QIC level of appeal, a review of a contractor
redetermination and a review of a contractor's dismissal of a request
for a redetermination are both characterized as a ``reconsideration.''
While the outcome of a QIC's reconsideration of a contractor dismissal
is differentiated and further reviews are not permitted in accordance
with current Sec. 405.974(b)(3), an ambiguity exists with regard to
the time frame for completing this type of reconsideration and
escalation options when that time frame is not met. Current Sec.
405.970 establishes the time frame for making a reconsideration without
further qualification. However, section 1869(b)(1)(D)(i) of the Act
establishes that a right to a reconsideration of an initial
determination (which includes a redetermination under section
1869(a)(3)(D) of the Act) exists if a timely request for a
reconsideration is filed within 180 days following receipt of a
contractor's redetermination, which is discussed in current Sec.
405.962. In contrast, current Sec. 405.974(b)(1) requires that a
request for a QIC reconsideration of a contractor's dismissal of a
request for redetermination must be filed within 60 calendar days after
receiving the contractor's notice of dismissal. Section 1869 of the Act
does not address dismissals. Rather, section 1869(c)(3)(C)(i) and
(c)(3)(C)(ii) of the Act only provide for a time frame to complete a
reconsideration of an initial determination, and an option to escalate
a case if that time frame is not met.
The effect of the ambiguity in current Sec. 405.970 is the
potential escalation of a request for a QIC reconsideration of a
contractor's dismissal when the reconsideration is not completed within
60 calendar days of a timely filed request for a reconsideration of the
dismissal, and a potential hearing being required in accordance with
current Sec. 405.1002(b). The potential effect of this ambiguity is
contrary to the policy of limiting reviews of dismissals to the next
adjudicative level of administrative appeal, as well as the statutory
construct for providing ALJ hearings after QIC reconsiderations of
redeterminations, or escalations of requests for reconsiderations
following a redetermination. We also note that in the parallel context
of an ALJ review of a QIC's dismissal of a request for reconsideration,
current Sec. Sec. 405.1002 and 405.1004 establish a clear distinction
between a request for hearing following a QIC reconsideration and a
request for a review of a QIC dismissal, and current Sec. Sec.
405.1016 and 405.1104 address the adjudication time frames for ALJ
decisions, and the option to escalate an appeal to the Council when a
time frame is not met, only in the context of a request for hearing, in
accordance with section 1869(d)(1) and (d)(3)(A) of the Act.
To address this unintended outcome of current Sec. 405.970, we are
proposing to amend the title of Sec. 405.970 and
[[Page 43800]]
paragraphs (a), (b)(1), (b)(2), (b)(3), (c), (e)(1), and (e)(2)(i) to
provide that the provisions would only apply to a request for a
reconsideration following a contractor redetermination, and not to a
request for QIC review of a contractor's dismissal of a request for
redetermination. These proposed revisions would further our policy on
reviews of dismissals and help appellants better understand what may be
escalated to OMHA for an ALJ hearing. We are also proposing to replace
``the ALJ hearing office'' in current paragraph (e)(2)(ii) with
``OMHA'' because the QIC sends case files for escalated cases to a
centralized location, not to individual field offices. We did not
propose any parallel changes for part 423 because subpart U does not
address IRE reconsiderations and subpart M does not have a provision
with the same ambiguity.
To provide additional clarity to the procedures for reviews of
dismissal actions we are also proposing to amend the text in Sec. Sec.
405.972(b)(3), (e) and 405.974(b)(3), and the introductory text of
Sec. 405.974(b) to replace the references to a ``reconsideration'' of
a contractor's dismissal of a request for redetermination with the word
``review'' so that the QIC's action is referred to as a review of a
contractor's dismissal of a request for redetermination. We are also
proposing to revise the section heading of Sec. 405.972 to read
``Withdrawal or dismissal of a request for reconsideration or review of
a contractor's dismissal of a request for redetermination'' and the
section heading of Sec. 405.974 to read, ``Reconsideration and review
of a contractor's dismissal of a request for redetermination.'' These
proposed revisions are consistent with the description of a
reconsideration in section 1869(c)(3)(B)(i) of the Act and Sec.
405.968(a). A QIC's review of a contractor dismissal action is limited
to the appropriateness of the dismissal action and does not consist of
a review of the initial determination and redetermination, which is the
meaning attributed to a reconsideration. In reviewing a contractor
dismissal action, the QIC either affirms or vacates the dismissal of
the request for redetermination. If a dismissal action is vacated, the
appeal is remanded back to the MAC to conduct a redetermination on the
merits (Sec. 405.974).
Current Sec. 405.972(e) provides that a QIC's dismissal of a
request for reconsideration is binding unless it is modified or
reversed by an ALJ under Sec. 405.1004. As discussed in section II.B
above, we are proposing that an attorney adjudicator may conduct a
review of a QIC's dismissal of a request for reconsideration and in
section III.A.3.c below, we are proposing to revise Sec. 405.1004 to
provide the effect of an attorney adjudicator's action taken in
reviewing the QIC dismissal is equivalent to the effect of an ALJ's
action taken in reviewing the QIC dismissal. To align with our proposed
revision to Sec. 405.1004, we are proposing to insert ``or attorney
adjudicator'' after ``an ALJ'' in Sec. 405.972(e) to indicate that a
QIC's dismissal of a request for reconsideration is binding unless it
is modified or reversed by an ALJ or attorney adjudicator under Sec.
405.1004.
We are inviting public comments on these proposals. If you choose
to comment on the proposals in this section, please include the caption
``Time frame for making a reconsideration following a contractor
redetermination, withdrawal or dismissal of a request for
reconsideration, and reconsideration'' at the beginning of your
comment.
j. Notice of Reconsideration (Sec. 405.976)
Section 1869(b)(3) of the Act states that a provider or supplier
may not introduce evidence in any appeal that was not presented at the
reconsideration conducted by a QIC unless there is good cause as to why
the evidence was not provided prior to the issuance of the QIC's
reconsideration. Under this authority, current Sec. 405.976(b)(5)(ii)
provides that a notice of reconsideration must include a summary of the
rationale for the reconsideration that specifies that all evidence that
is not submitted prior to the issuance of the reconsideration will not
be considered at the ALJ level, or made part of the administrative
record, unless the appellant demonstrates good cause as to why the
evidence was not provided prior to the issuance of the QIC's
reconsideration; however, it does not apply to a beneficiary unless the
beneficiary is represented by a provider or supplier or to state
Medicaid agencies. The statement that the evidence will not be made
part of the administrative record is inconsistent with our practice of
making a complete record of the administrative proceedings for further
reviews, including documents submitted by parties that were not
considered in making the decision. Current Sec. 405.1028(c) states
that if good cause does not exist, the ALJ must exclude the evidence
from the proceedings and may not consider it in reaching a decision.
However, it does not instruct the ALJ to remove the evidence from the
administrative record, and to do so would preclude an effective review
of the good cause determination. In addition, we noted in the 2005
Interim Final Rule (70 FR 11464) that under current Sec.
405.1042(a)(2), excluded evidence is part of the record because it
states that in the record, the ALJ must also discuss any evidence
excluded under Sec. 405.1028 and include a justification for excluding
the evidence. To help ensure that the evidence is preserved in the
administrative record, we are proposing to delete ``or made part of the
administrative record'' from the paragraph in Sec. 405.976(b)(5)(ii).
Current Sec. 405.976(b)(7) requires that the QIC notice of
reconsideration contain a statement of whether the amount in
controversy needed for an ALJ hearing is met when the reconsideration
is partially or fully unfavorable. As further discussed in section
III.A.3.d below, we are proposing revisions to Sec. 405.976(b)(7)
along with revisions to the methodology for calculating the amount in
controversy required for an ALJ hearing under Sec. 405.1006(d) to
better align the amount in controversy with the actual amount in
dispute. Please refer to section III.A.3.d for a discussion of these
proposals.
We are not proposing any changes to part 423 because subpart U does
not address IRE reconsiderations and subpart M does not contain similar
provisions.
We are inviting public comments on this proposal. If you choose to
comment on the proposal in this section, please include the caption
``Notice of reconsideration'' at the beginning of your comment.
k. Effect of a Reconsideration (Sec. 405.978)
Current Sec. 405.978 discusses the effect of a QIC
reconsideration, and states that a reconsideration is binding on all
parties unless, among other things, an ALJ decision is issued in
accordance to a request for an ALJ hearing made in accordance with
Sec. 405.1014. As discussed in section II.B above, we are proposing
that an attorney adjudicator may issue a decision on a request for an
ALJ hearing when a hearing is not conducted, and in section III.A.3.v
below, we are proposing to revise Sec. 405.1048 to provide the effect
of an attorney adjudicator's decision is equivalent to the effect of an
ALJ's decision. To align with our proposals to provide that an attorney
adjudicator may issue a decision on a request for an ALJ hearing when a
hearing is not conducted and the effect of that decision is equivalent
to the effect of an ALJ's decision, we are proposing to insert ``or
attorney adjudicator'' after the first use of ``ALJ'' in Sec.
405.978(a) to
[[Page 43801]]
indicate that a QIC reconsideration is binding on all parties unless,
among other things, an ALJ or attorney adjudicator decision is issued
in accordance to a request for an ALJ hearing made in accordance with
Sec. 405.1014.
We are inviting public comments on this proposal. If you choose to
comment on the proposal in this section, please include the caption
``Effect of a reconsideration'' at the beginning of your comment.
l. Reopenings (Sec. Sec. 405.980, 405.982, 405.984, 423.1978,
423.1980, 423.1982, and 423.1984)
Sections 405.980 and 423.1980 set forth the rules governing
reopening and revision of initial determinations, redeterminations,
reconsiderations, decisions, and reviews; Sec. Sec. 405.982 and
423.1982 set forth the rules governing notice of a revised
determination or decision; and Sec. Sec. 405.984 and 423.1984 set
forth the rules on the effect of a revised determination or decision.
Pursuant to current Sec. Sec. 405.1038 and 423.2038, an ALJ may issue
a decision on a request for hearing without conducting a hearing in
specified circumstances. As proposed in section II.B above, an attorney
adjudicator also would be able to issue decisions on requests for an
ALJ hearing in specified circumstances, issue dismissals when a party
withdraws a request for hearing, and issue decisions on requests to
review QIC or IRE dismissals.
We are proposing to insert ``or attorney adjudicator'' or
``attorney adjudicator's,'' after ``ALJ'' or ``ALJ's'' in Sec. Sec.
405.980(a)(1)(iii), (a)(4), (a)(5), (d) introductory text, (d)(2),
(e)(2); 405.982(a), (b); 405.984(d); 423.1980(a)(1)(iii), (a)(4), (d)
introductory text, (d)(2), (e)(2); 423.1982(a), (a)(1), (a)(2), (b),
(b)(1), and (b)(2); 423.1984(d); 423.1978(a); 423.1980(a)(2). These
proposals would provide that decisions issued by attorney adjudicators,
as proposed in section II.B above, may be reopened in the same manner
as decisions issued by an ALJ (that is, when there is good cause in
accordance with Sec. Sec. 405.986 or 423.1986, or the decision was
procured by fraud or similar fault), and with the same limitations,
requirements, and effects as reopening an ALJ decision. We believe it
is necessary for an attorney adjudicator or the Council to have the
authority to reopen the attorney adjudicator's decision on the same
bases as an ALJ or the Council may reopen the ALJ's decision under the
current rules; to address instances in which there is good cause to
reopen the attorney adjudicator's decision (in accordance with
Sec. Sec. 405.986 or 423.1986) or the attorney adjudicator's decision
was procured by fraud or similar fault; and the action should be
subject to the same limitations and requirements, and have the same
effects as an ALJ's action under the provisions.
We are also proposing to replace ``hearing decision,'' ``hearing
decisions,'' or ``hearings,'' with ``decision'' or ``decisions'' in the
titles of current Sec. Sec. 405.980 and 423.1980; Sec. Sec.
405.980(a)(1)(iii), (d) introductory text, (d)(2), (e) introductory
text, and (e)(2); 423.1980(a)(1)(iii), (d) introductory text, (d)(2),
(e) introductory text, and (e)(2); to replace ``hearing'' with ``ALJ or
attorney adjudicator decision'' in Sec. Sec. 405.980(a)(1)(iv),
(a)(4), (e)(2); 423.1980(a)(1)(iv), (a)(2), and (e)(2); and to replace
``ALJ hearing decisions'' and ``hearing decision,'' with ``ALJ or
attorney adjudicator decisions'' and ``ALJ or attorney adjudicator
decision'', respectively, in Sec. Sec. 405.984(d) and 423.1984(d).
These proposals would avoid any confusion that reopening under these
provisions is limited to decisions for which an oral hearing was
conducted, whether the decision is issued by an ALJ without conducting
a hearing, as permitted under current rules or by an attorney
adjudicator without conducting a hearing, as proposed in section II.B
above.
In addition, we are proposing to add in Sec. Sec.
405.980(a)(1)(iii), (d)(2), (e)(2), and 423.1980(a)(1)(iii), (d)(2),
(e)(2) that an ALJ, or attorney adjudicator as proposed in section II.B
above, revises ``his or her'' decision and may reopen ``his or her''
decision, which reflects our current policy that the deciding ALJ may
reopen his or her decision, and avoids any potential confusion that an
ALJ or attorney adjudicator may reopen the decision of another ALJ or
attorney adjudicator. We are also proposing to insert ``its'' before
``review'' in Sec. Sec. 405.980(a)(1)(iv) and 423.1980(a)(1)(iv) to
indicate that the Council's review decision may only be reopened by the
Council, to differentiate it from an ALJ or attorney adjudicator
decision that the Council may also reopen. In addition, we are
proposing to specify in Sec. Sec. 405.980(d)(2) and (e)(2), and
423.1980(d)(2) and (e)(2) that the Council may reopen ``an ALJ or
attorney adjudicator'' decision consistent with the current policy that
the Council may reopen an ALJ decision, and to differentiate the
provisions from Sec. Sec. 405.980(d)(3) and (e)(3), and 423.1980(d)(3)
and (e)(3), which provide for the Council to reopen its review
decision. We also propose in Sec. 405.980(e)(3) to insert ``Council''
before ``review'' to clarify that a party to a Council review may
request that the Council reopen its decision.
Finally, we are proposing at Sec. 405.984(c) to replace ``in
accordance with Sec. 405.1000 through Sec. 405.1064'' with ``in
accordance with Sec. 405.1000 through Sec. 405.1063'' to account for
the proposed removal of Sec. 405.1064 discussed below.
We are inviting public comments on these proposals. If you choose
to comment on the proposals in this section, please include the caption
``Reopenings'' at the beginning of your comment.
m. Expedited Access to Judicial Review (Sec. Sec. 405.990 and
423.1990)
Sections 405.990 and 423.1990 set forth the procedures governing
expedited access to judicial review (EAJR). Current Sec. Sec.
405.990(d) and 423.1990(d) allow a requesting party to file an EAJR
request with an ALJ or the Council, which is then responsible for
forwarding the request to the EAJR review entity within 5 calendar days
of receipt. In accordance with current Sec. Sec. 405.990(f) and
423.1990(e), a request for EAJR must be acted upon by the EAJR review
entity within 60 calendar days after the date that the review entity
receives a request and accompanying documents and materials. In
practice, this process has resulted in confusion and delays for
requesting parties when EAJR requests are sent directly to an ALJ or
the Council. To simplify the process for requesting parties and to help
ensure the timely processing of EAJR requests, we are proposing to
revise Sec. Sec. 405.990(d)(1) and 423.1990(d)(1) to direct EAJR
requests to the DAB, which administers the EAJR process. Specifically,
we are proposing at Sec. Sec. 405.990(d)(1)(i) and (ii), and
423.1990(d)(1)(i) and (ii) that the requestor or enrollee may file a
written EAJR request with the DAB with the request for ALJ hearing or
Council review if a request for ALJ hearing or Council review is not
pending, or file a written EAJR request with the DAB if an appeal is
already pending for an ALJ hearing or otherwise before OMHA or the
Council. We are also proposing to revise Sec. Sec. 405.990(i)(1) and
(2) and 423.1990(h)(1) and (2) so that the review entity would forward
a rejected EAJR request to OMHA or the Council instead of an ALJ
hearing office or the Council, to align with the revised EAJR filing
process in which a request for ALJ hearing is submitted to the DAB with
an EAJR request; this would also help ensure OMHA can process the
request for an ALJ hearing as quickly as possible in the event an EAJR
request is rejected.
[[Page 43802]]
Current Sec. Sec. 405.990(i)(2) and 423.1990(h)(2) provide that a
90 calendar day time frame will apply to an appeal when a rejected EAJR
request is received by the hearing office or the Council. Current Sec.
405.990(b)(1)(ii) states that an EAJR request may be filed when a
request for a QIC reconsideration has been escalated for an ALJ
hearing, and in accordance with current Sec. 405.1016(c), a 180
calendar day time frame will apply in that circumstance. In addition,
current Sec. Sec. 405.1036(d) and 423.2036(d) allow an appellant or
enrollee to waive the adjudication period for an ALJ to issue a
decision specified in Sec. Sec. 405.1016 and 405.2016, respectively,
at any time during the hearing process. To address the possibility that
a time frame other than 90 calendar days applies to an appeal, or no
adjudication time frame applies to an appeal, we are proposing to
revise Sec. Sec. 405.990(i)(2) and 423.1990(h)(2) to remove the
reference to 90 calendar days and provide that if an adjudication time
frame applies to an appeal, the adjudication time frame begins on the
day the request for hearing is received by OMHA or the request for
review is received by the Council, from the EAJR review entity.
In addition, proposed Sec. 405.990(i)(1) would remove the
redundant ``request'' after ``EAJR request'' in current paragraph
(i)(1), which was a drafting error; and proposed Sec.
423.1990(b)(1)(i) would remove ``final'' before referring to a
decision, dismissal, or remand order of the ALJ or attorney
adjudicator, as proposed in section II.B above, because as we explained
in the 2009 Final Rule (74 FR 65307 through 65308), final decisions of
the Secretary are those for which judicial review may be immediately
sought under section 205(g) of the Act and the use of ``final'' in
current Sec. 423.1990(b)(1)(i) may cause confusion with such a final
decision.
We are inviting public comments on these proposals. If you choose
to comment on the proposals in this section, please include the caption
``Expedited access to judicial review'' at the beginning of your
comment.
3. ALJ Hearings
a. Hearing Before an ALJ and Decision by an ALJ or Attorney
Adjudicator: General Rule (Sec. Sec. 405.1000 and 423.2000)
Current Sec. Sec. 405.1000 and 423.2000 provide a general overview
and rules for hearings before an ALJ and decisions on requests for
hearings. We are proposing to revise Sec. Sec. 405.1000(d), (e), (g);
and 423.2000(d), (e), (g) to include decisions by attorney
adjudicators, as proposed in section II.B above. We are also proposing
to retitle the sections to reflect that the provisions of the section
extend to decisions by both ALJ and attorney adjudicators. We are
proposing to change the language in Sec. Sec. 405.1000(a), (b), (c),
and (d); and 423.2000(a) and (b) to state that a hearing may only be
conducted by an ALJ. These proposals would provide readers with an
accurate overview of how a request for an ALJ hearing would be
adjudicated, including the potential that a decision could be issued
without conducting a hearing by an ALJ or an attorney adjudicator as
proposed in section II.B above, while informing readers that if a
hearing is conducted, an ALJ will conduct the hearing.
Current Sec. 405.1000(c) provides that CMS or a contractor may
elect to participate in a hearing, and Sec. 423.2000(c) provides that
CMS, the IRE or Part D plan sponsor may request to participate in a
hearing. As discussed in section III.A.3.f below, we are proposing to
revise Sec. Sec. 405.1010 and 423.2010 so that these entities may
elect (for Sec. 405.1010) or request (for Sec. 423.2010) to
participate in the proceedings on a request for hearing, including
participation before a hearing is scheduled. We are proposing to revise
Sec. Sec. 405.1000(c) and 423.2000(c) so that the sections would
reference Sec. Sec. 405.1010 and 423.2010, respectively, with regard
to participating in the proceedings. By referencing Sec. Sec. 405.1010
and 423.2010, the proposed revisions would direct readers to those
sections addressing the full scope of potential participation by CMS or
its contractors, or a Part D plan sponsor, on a request for an ALJ
hearing, including participating in the proceedings on a request for an
ALJ hearing, which as discussed in proposed Sec. Sec. 405.1010 and
423.2010, may include any proceedings before an oral hearing is
scheduled. We are also proposing in Sec. 405.1000(c) to state that CMS
or its contractor may join the hearing before an ALJ as a party under
Sec. 405.1012, which would direct readers to the appropriate section
addressing the full scope of CMS or its contractor acting as a party.
(Because CMS, the IRE, and the Part D plan sponsor may not be a party
to a hearing under part 423, subpart U, there is no corollary to Sec.
405.1012 in that subpart and therefore a similar revision is not
proposed for Sec. 423.2000(c).)
Current Sec. Sec. 405.1000(d) and 423.2000(d) provide that a
decision is based on the hearing record, and current Sec. Sec.
405.1000(g) and 423.2000(g) reference a hearing record in describing
when a decision can be issued based on the record, without a hearing.
However, current Sec. Sec. 405.1042 and 423.2042 identify the record
as the administrative record. The references to a hearing record in
current paragraphs (d) and (g) may cause confusion when no hearing is
conducted. To make the terminology consistent throughout the rules,
account for decisions that are issued without a hearing being
conducted, and minimize confusion, we are proposing to revise
Sec. Sec. 405.1000(d) and 423.2000(d) so that a decision is based on
the administrative record, including, for an ALJ, any hearing record,
and Sec. Sec. 405.1000(g) and 423.2000(g) to provide that a decision
is based on the administrative record.
Current Sec. 405.1000(e) and (g) discuss two circumstances in
which a decision on a request for hearing can be issued by an ALJ
without conducting a hearing, either where the parties waive the
hearing or where the record supports a fully favorable finding. Related
to current Sec. 405.1000(e), current Sec. 405.1000(f) discusses the
ALJ's authority to conduct a hearing even if the parties waive the
hearing. As discussed in section III.A.3.r below, we are proposing to
revise Sec. 405.1038 to modify the circumstances in which a decision
on a request for hearing can be issued without conducting a hearing. As
discussed in the proposed revisions to Sec. 405.1038, we would require
that waivers be obtained by the parties entitled to a notice of hearing
in accordance with Sec. 405.1020(c), or to require that the record
supports a fully favorable finding for the appellant and there is no
other party or no other party is entitled to a notice of hearing in
accordance with Sec. 405.1020(c). Proposed Sec. 405.1000(e), (f), and
(g) would be revised for consistency with the Sec. 405.1038 proposals
and to accurately summarize when a decision on a request for hearing
can be issued without conducting a hearing in accordance with proposed
Sec. 405.1038. We are not proposing similar changes in Sec.
423.2000(e), (f), and (g) because we are not proposing changes to when
a decision on a request for hearing can be issued without conducting a
hearing in Sec. 423.2038.
Current Sec. 405.964(c) requires a QIC to consolidate requests for
a reconsideration filed by different parties on the same claim before a
reconsideration is made on the first timely filed request. While
current Sec. 405.1044 permits an ALJ to consolidate requests for
hearing if one or more of the issues to be considered at the hearing
are the same issues that are involved in another request for hearing
pending before the same ALJ, the provision is discretionary and
dependent on the requests being
[[Page 43803]]
assigned to the same ALJ. To mitigate the potential of requests for
hearing on the same claim filed by different parties being separately
adjudicated, we are proposing to add Sec. 405.1000(h) to require that
when more than one party files a timely request for hearing on the same
claim before a decision is made on the first timely filed request, the
requests are consolidated into one proceeding and record, and one
decision, dismissal, or remand is issued. We note that if a decision
was issued on the first timely request before an additional request is
timely filed or good cause is found to extend the period to file the
additional request for hearing, a reopening of the decision may be
considered by the deciding adjudicator in accordance with Sec.
405.980. For example, if a request is submitted with new and material
evidence that was not available at the time of the decision and may
result in a different conclusion, the reopening provisions at Sec.
405.980 would apply. Because only the enrollee is a party in a part
423, subpart U proceeding on a request for an ALJ hearing, no
corresponding changes are proposed for Sec. 423.2000.
We are inviting public comments on these proposals. If you choose
to comment on the proposals in this section, please include the caption
``Hearing before an ALJ and decision by an ALJ or attorney adjudicator
general rule'' at the beginning of your comment.
b. Right to an ALJ Hearing (Sec. Sec. 405.1002 and 423.2002)
Current Sec. Sec. 405.1002 and 423.2002 discuss a right to an ALJ
hearing. Current Sec. Sec. 405.1002(a) and 423.2002(a) provide that a
party to a QIC reconsideration or the enrollee who receives an IRE
reconsideration, respectively, may ``request'' a hearing before an ALJ
if the party or enrollee files a timely request and meets the amount in
controversy requirement. However, a party or enrollee is entitled to a
hearing only when those requirements are met. See sections 1860D-4(h)
and 1869(b)(1)(A) of the Act. Therefore, we are proposing to revise
Sec. Sec. 405.1002(a) and 423.2002(a) introductory text to state that
the party to a QIC reconsideration or the enrollee who receives an IRE
reconsideration has a right to a hearing rather than may request a
hearing. These proposed changes would align the provisions with the
statute and clarify that the party or enrollee has a right to a hearing
before an ALJ when the criteria are met.
Current Sec. Sec. 405.1002(a)(4) and 423.2002(e) provide that the
request is considered filed on the date it is received by the entity
specified in the QIC's or IRE's reconsideration. There has been
confusion when a request is sent to an OMHA office that is not
specified in the reconsideration, and this error causes delays in
processing the request. We are proposing to revise Sec. Sec.
405.1002(a)(4) and 423.2002(e) to replace ``entity'' with ``office'' to
avoid confusion that the request may be filed with OMHA as an entity,
and therefore any OMHA office, rather than the specific OMHA office
identified in the QIC's or IRE's reconsideration. This would help
ensure appellants are aware that a request for hearing must be filed
with the office indicated in the notice of reconsideration to avoid
delays. For example, when the notice of reconsideration indicates that
a request for hearing must be filed with the OMHA central docketing
office, an appellant will cause a delay if the request is sent to the
QIC or IRE, or an OMHA field office. We also note that as explained in
the 2009 Final Rule (74 FR 65319 through 65320), pursuant to current
Sec. 405.1014(b)(2), if a request for hearing is timely filed with an
entity other than the entity specified in the notice of
reconsideration, the request is not treated as untimely or otherwise
rejected. This would remain true for requests that are timely filed
with an office other than the office specified in the notice of
reconsideration, pursuant to proposed Sec. 405.1014(c)(2), which
incorporates the requirement from current Sec. 405.1014(b)(2). This
would also apply in part 423, subpart U adjudications because the same
language appears in current Sec. 423.2014(c)(2) and is incorporated in
proposed Sec. 423.2014(d)(2).
Current Sec. 405.1002(b)(1) provides that when a party files a
request with the QIC to escalate the appeal, it is escalated to ``the
ALJ level.'' We are proposing to revise Sec. 405.1002(b)(1) to replace
``to the ALJ level'' with ``for a hearing before an ALJ'' so that when
a request for a QIC reconsideration is escalated, it is escalated ``for
a hearing before an ALJ.'' This would help ensure that the right to a
hearing is clear when an appeal is escalated from the QIC. There is no
corresponding provision in part 423, subpart U.
Current Sec. 423.2002(c) provides that the ALJ must document all
oral requests for expedited hearings. However, an ALJ is not assigned
to an appeal until after the request for hearing is received and
processed. Thus, we are proposing to revise Sec. 423.2002(c) to state
that ``OMHA'' must document all oral requests for expedited hearings.
There is no corresponding provision in part 405, subpart I.
We are inviting public comments on these proposals. If you choose
to comment on the proposals in this section, please include the caption
``Right to an ALJ hearing'' at the beginning of your comment.
c. Right to a Review of QIC or IRE Notice of Dismissal (Sec. Sec.
405.1004 and 423.2004)
Current Sec. Sec. 405.1004 and 423.2004 discuss the right to an
ALJ review of a QIC notice of dismissal or IRE notice of dismissal,
respectively. As proposed in section II.B above, attorney adjudicators
or ALJs would conduct reviews of QIC or IRE dismissals. Accordingly, we
are proposing to remove references to an ALJ in the titles of proposed
Sec. Sec. 405.1004 and 423.2004, though ALJs would continue to have
the authority to conduct reviews of QIC or IRE dismissals if a request
for a review of a QIC or IRE dismissal is assigned to an ALJ. We also
propose to insert ``or attorney adjudicator'' after ALJ in Sec. Sec.
405.1004(a) introductory language, (b), (c); and 423.2004(a)
introductory language, (b), and (c), to provide that an attorney
adjudicator could review a QIC or IRE dismissal, as proposed in section
II.B above. We also are proposing to replace the reference to
``entity'' in current Sec. Sec. 405.1004(a)(4) and 423.2004(a)(4),
with ``office,'' for the same reasons discussed above in III.A.3.b, for
amending parallel language in Sec. Sec. 405.1002 and 423.2002.
Current Sec. Sec. 405.1004(b) and 423.2004(b) provide that if an
ALJ determines that the QIC's or IRE's dismissal was in error, he or
she vacates the dismissal and remands the case to a QIC or IRE. As
discussed in III.A.3.p below, we are proposing to revise the remand
provisions and add new Sec. Sec. 405.1056 and 405.1058, 423.2056, and
423.2058 to govern when remands may be issued, whether and to what
extent remands may be reviewed, providing notice of a remand, and the
effect of a remand. We are also proposing to revise Sec. Sec.
405.1004(b) and 423.2004(b) to add references to proposed Sec. Sec.
405.1056 and 423.2056, respectively, to explain that the remand would
be in accordance with proposed Sec. Sec. 405.1056 and 423.2056, which
as discussed in section III.A.3.p below, would address issuing remands
and notices thereof, including for remands of QIC or IRE dismissals.
Current Sec. Sec. 405.1004(c) and 423.2004(c) state that an ALJ's
decision regarding a QIC's or IRE's dismissal of a reconsideration
request is binding and not subject to further review, and that the
dismissal of a request for ALJ review of a QIC's or IRE's dismissal of
a
[[Page 43804]]
reconsideration request is binding and not subject to further review,
unless vacated by the Council under Sec. 405.1108(h) or Sec.
423.2108(b), respectively. In our experience, these sections as
currently drafted have been a source of confusion for adjudicators and
appellants. The two sentences convey different actions that can result
from a request for review of a QIC or IRE dismissal--a decision
regarding whether the QIC's or IRE's dismissal was correct, or a
dismissal of the appellant's request for an ALJ review of the QIC's or
IRE's dismissal. We are proposing to separate and further distinguish
the two situations to avoid the current confusion that results from two
of the three possible outcomes that may result from a request to review
a QIC or IRE dismissal (the third being a remand of the dismissal,
addressed in paragraph (b) in the respective sections) being in the
same paragraph by proposing a separate paragraph for each outcome
currently addressed in paragraph (c).
We are proposing to revise Sec. Sec. 405.1004(c) and 423.2004(c)
to include the possible outcome in the first sentence of current
Sec. Sec. 405.1004(c) and 423.2004(c) of a decision affirming the
QIC's or IRE's dismissal. We also are proposing to move language in
current Sec. Sec. 405.1004(c) and 423.2004(c) stating that the
decision of an ALJ on a request for review of a QIC dismissal is
binding and not subject to further review, to proposed Sec. Sec.
405.1048(b) and 423.2048(b), which as discussed in section III.A.3.v
below, would address the effects of decisions on requests to review a
QIC or IRE dismissal. In addition, we are proposing in Sec. Sec.
405.1004(c) and 423.2004(c), respectively, to state that a decision
affirming a QIC or IRE dismissal would be issued in accordance with
proposed Sec. Sec. 405.1046(b) and 423.2046(b), which as discussed in
section III.A.3.v below, would address issuing decisions on requests
for review of a QIC or IRE dismissal and notices thereof.
The 2009 Final Rule (74 FR 65311 through 65312) also explained that
if a request for ALJ review of a QIC dismissal was invalid and thus
subject to dismissal, the dismissal of the request to review a QIC
dismissal was binding and not subject to further review (however, a
party could request that the dismissal be vacated by the Council
pursuant to Sec. 405.1108(b)). We are proposing to add Sec. Sec.
405.1004(d) and 423.2004(d) to state that the ALJ or attorney
adjudicator may dismiss a request for review of a QIC's or an IRE's
dismissal in accordance with proposed Sec. Sec. 405.1052(b) or
423.2052(b), respectively, which as discussed in section III.A.3.x
below, would address dismissals of requests for review of a QIC or IRE
dismissal and notices thereof. We also are proposing to move language
in current Sec. Sec. 405.1004(c) and 423.2004(c) stating that the
dismissal is binding and not subject to further review unless the
dismissal is vacated, to proposed Sec. Sec. 405.1054(b) and
423.2054(b), which would address the effects of a dismissal of a
request for review of a QIC's or an IRE's dismissal and as discussed in
section III.A.3.x below, would provide authority for an ALJ or attorney
adjudicator to vacate a dismissal and therefore replace the current
reference to the Council.
We are inviting public comments on these proposals. If you choose
to comment on the proposals in this section, please include the caption
``Right to a review of QIC or IRE notice of dismissal'' at the
beginning of your comment.
d. Amount in Controversy Required for an ALJ Hearing (Sec. Sec.
405.1006, 405.976(b)(7), 423.1970, 422.600(b), and 478.44(a))
Current Sec. 405.1006 sets forth the requirements for meeting the
amount in controversy for an ALJ hearing. The title of current Sec.
405.1006 states that the amount in controversy is required to
``request'' an ALJ hearing and judicial review. However, as discussed
in III.A.3.b above, section 1869(b)(1)(A) of the Act states that a
party is entitled to a hearing before the Secretary and judicial
review, subject to the amount in controversy and other requirements. To
align the title of Sec. 405.1006 with the statutory provision, we are
proposing that the amount in controversy is required ``for'' an ALJ
hearing and judicial review rather than ``to request'' an ALJ hearing
and judicial review. Put another way, a party may request an ALJ
hearing or judicial review, albeit unsuccessfully, without satisfying
the amount in controversy requirement.
Section 1869(b)(1)(E) of the Act establishes the minimum amounts in
controversy for a hearing by the Secretary and for judicial review, but
does not establish how to calculate the amounts in controversy. Current
Sec. 405.1006(d) states that the amount remaining in controversy is
calculated based on the actual amount charged to the individual (a
beneficiary) for the items or services in question (commonly referred
to as billed charges), reduced by any Medicare payments already made or
awarded for the items or services, and any deductible and coinsurance
amounts applicable to the particular case. In an effort to align the
amount in controversy with a better approximation of the amount at
issue in an appeal, we are proposing to revise the basis (that is, the
starting point before any deductions for any payments already made by
Medicare or any coinsurance or deductible that may be collected) used
to calculate the amount in controversy. For appeals of claims submitted
by providers of services, physicians, and other suppliers that are
priced based on a published Medicare fee schedule or published
contractor priced amount (as discussed below), rather than using the
actual amount charged to the individual as the basis for the amount in
controversy, we are proposing to use the Medicare allowable amount for
the items and/or services being appealed, subject to the exceptions
discussed below. An allowable amount is the maximum amount of the
billed charge deemed payable for the item or service. For the purposes
of the amount in controversy under Sec. 405.1006, we are proposing at
Sec. 405.1006(d)(2)(i)(A) that for items and services with a published
Medicare fee schedule or published contractor-priced amount, the basis
for the amount in controversy is the allowable amount, which would be
the amount reflected on the fee schedule or in the contractor-priced
amount for those items or services in the applicable jurisdiction and
place of service.
For a vast majority of items and services furnished and billed by
physicians and other suppliers, allowable amounts are determined based
on Medicare fee schedules. Fee schedules are updated and published on
an annual basis by CMS through rulemaking, and CMS and its contractors
have tools and resources available to inform physicians and other
suppliers of allowable amounts based on these fee schedules, including
the Physician Fee Schedule Look-up Tool available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PFSlookup/ and
spreadsheets for other fee schedules that can be accessed on the CMS
Web site through the fee schedule main page at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/FeeScheduleGenInfo/. Allowable amounts for many contractor priced items and
services are also included in these tools and resources. Allowable
amounts are included on the Medicare remittance advice for paid items
and services, but not for items and services that are denied. However,
where the allowable amount for an item or service is determined based
on a published fee schedule or contractor priced amount, we anticipate
that appellants, other than beneficiaries who
[[Page 43805]]
are not represented by a provider, supplier, or Medicaid State agency,
would be able to use the existing CMS and contractor tools and
resources to determine allowable amounts for denied services when
filing a request for hearing, and those amounts could be verified by
OMHA in determining whether the claims included in the request meet the
amount in controversy requirement. As discussed below, where the
appellant is a beneficiary who is not represented by a provider,
supplier, or Medicaid State agency, CMS would require the QIC to
specify in the notice of reconsideration, for partially or fully
unfavorable reconsideration decisions, whether the amount remaining in
controversy is estimated to meet or not meet the amount required for an
ALJ hearing under proposed Sec. 405.1006(d).
Due to the pricing methodology for many items and services
furnished by providers of services, such as hospitals, hospices, home
health agencies, and skilled nursing facilities, at the present time an
allowable amount is not easily discerned or verified with existing CMS
and contractor pricing tools (for example, there is no pricing tool
available for hospital outpatient services paid under the outpatient
prospective payment system (OPPS)) for pre-payment claim denials (where
items or services on the claim are denied, in full or in part, before
claim payment has been made). Similarly, items and services furnished
by providers or suppliers that are always non-covered, as well as
unlisted procedures, may not have published allowable amounts based on
a fee schedule or a published contractor-priced amount. Therefore, we
are proposing at Sec. 405.1006(d)(2)(i)(B) to continue using the
provider's or supplier's billed charges as the basis for calculating
the amount in controversy for appeals of claims that are not priced
according to a CMS-published fee schedule and do not have a published
contractor-priced amount (except as discussed below). We note that the
method for calculating the amount in controversy in this scenario would
be the same as under current Sec. 405.1006(d), and we believe that all
appellants have access to this information through claims billing
histories, remittance advices, or the column titled ``Amount Provider
[or Supplier] Charged'' on the Medicare Summary Notice. However, we are
soliciting comment on whether existing tools and resources are
available that would enable providers, suppliers, and Medicaid State
agencies to submit an allowable amount in their request for hearing (as
proposed in Section III.A.3.g.i below) for items and services not
subject to published fee schedules or published contractor priced
amounts, and whether those amounts could also be verified by OMHA. We
are also soliciting comment on how such tools and resources could be
used in appeals filed by beneficiaries.
Current Sec. 405.1006(d)(1) introductory text uses ``the actual
amount charged the individual for the items and services in question''
as the basis (starting point) for calculating the amount in
controversy, before any reductions described in paragraphs (d)(1)(i)
and (ii) (for any Medicare payments already made or awarded and any
deductible and coinsurance applicable in the particular case) occur.
For the reasons discussed above, we are proposing to revise paragraph
(d)(1) introductory text to state that in situations other than those
described in Sec. 405.1006(d)(3) through (7) (discussed below), the
amount in controversy is computed as ``the basis for the amount in
controversy for the items and services in the disputed claim as defined
in paragraph (d)(2)'', less applicable reductions described in
paragraphs (d)(1)(i) and (ii), and are proposing to revise paragraph
(d)(2) to specify the amount that would be used as the basis for the
amount in controversy on a situational basis. We are also proposing at
Sec. 405.1006(d)(3) through (7) five exceptions to the general
calculation methodology specified in proposed paragraphs (d)(1) and
(2).
There has also been confusion in calculating the amount in
controversy when an appealed reconsideration involves multiple claims.
Section 1869 of the Act and part 405, subpart I provide for an appeals
process in which each claim decision is appealed and separately
adjudicated. However, in some instances, claims are considered together
based on an appellant's request. To address confusion with calculating
the amount in controversy when reconsiderations involve multiple claims
and to help ensure Sec. 405.1006 clearly conveys that the amount in
controversy requirement must be met for each appealed claim unless the
claim can be aggregated as discussed below, proposed Sec.
405.1006(d)(1) would clarify that the amount in controversy is based on
the items or services in the disputed ``claim.''
We are proposing to maintain the current reduction to the
calculation of the amount in controversy in Sec. 405.1006(d)(1)(i),
which states that the basis for the amount in controversy is reduced by
any Medicare payments already made or awarded for the items or
services. In addition, current Sec. 405.1006(d)(1)(ii) provides that
the basis for the amount in controversy is further reduced by ``[a]ny
deductible and coinsurance amounts applicable in the particular case.''
We are proposing to revise Sec. 405.1006(d)(1)(ii) to read, ``Any
deductible and/or coinsurance amounts that may be collected for the
items or services.'' We believe revising this provision is appropriate
to better align the amount at issue in the appeal and the amount in
controversy so that in situations where a provider or supplier is
prohibited from collecting applicable coinsurance and/or deductible, or
must refund any such amounts already collected, the basis for the
amount in controversy is not reduced by that amount (for example, if a
provider or supplier is held liable for denied services under the
limitation on liability provision in section 1879 of the Act, any
amounts collected for the denied service, including coinsurance and/or
deductible must be refunded).
As discussed above, we are proposing at Sec. 405.1006(d)(2)(i)
that, for situations other than those described in Sec.
405.1006(d)(2)(ii) and (iii), the basis for calculating the amount in
controversy under Sec. 405.1006(d)(1) would be the Medicare allowable
amount, which is the amount reflected on the fee schedule or in the
contractor-priced amount for those items or services in the applicable
jurisdiction and place of service if there is a published Medicare fee
schedule or published contractor-priced amount for the items or
services in the disputed claim; or if there is no published Medicare
fee schedule or contractor-priced amount for the items or services in
the disputed claim, the basis for the amount in controversy would be
the provider or supplier's billed charges submitted on the claim for
the items and services. We believe providers, suppliers, and Medicaid
State agencies would be able to utilize existing CMS and CMS contractor
tools and resources to determine the allowable amount for items and
services with published fee schedule or published contractor-priced
amounts, and for items or services without a published fee schedule or
published contractor priced amount, the calculation methodology for the
amount in controversy would be the same as the calculation methodology
specified in current Sec. 405.1006(d). However, there may be instances
where a beneficiary would appeal a claim for items and services for
which the allowable amount would be the basis for the amount in
controversy under proposed Sec. 405.1006(d)(2)(i)(A) (for example, a
claim for items or services with a published fee schedule or published
[[Page 43806]]
contractor-priced amount that does not involve an overpayment and for
which the beneficiary has not been determined to be financially
responsible). We believe most beneficiaries are not familiar with
published fee schedule or contractor-priced amounts and may be unable
to determine the amount in controversy in these circumstances with the
resources currently available to them. However, as discussed below, we
are proposing at Sec. 405.976(b)(7) that the QIC include in the notice
of reconsideration a statement of whether the amount in controversy is
estimated to meet or not meet the amount required for an ALJ hearing,
if the request for reconsideration was filed by a beneficiary who is
not represented by a provider, supplier, or Medicaid State agency, and
the reconsideration is partially or fully unfavorable to the appellant.
For appeals filed by beneficiaries, often the amount at issue is
aligned not with the Medicare allowable amount, but rather with the
billed charges of the provider or supplier. For example, where a
beneficiary is held financially responsible for a denied claim under
the limitation on liability provisions in section 1879 of the Act
because he or she received an Advance Beneficiary Notice of Noncoverage
(ABN), the beneficiary is responsible for the billed charges on the
claim. Or, for a claim not submitted on an assignment-related basis
that is denied, the beneficiary may be responsible for the billed
charges, or the billed charges subject to the limiting charge in
section 1848(g) of the Act. Medicare notifies the beneficiary of the
amount he or she may be billed for denied services on the Medicare
Summary Notice in a column titled, ``Maximum You May Be Billed.'' For
appeals filed by a provider, supplier, or Medicaid State agency for
denied items or services for which the beneficiary was determined to be
financially responsible, we believe providers, suppliers, and Medicaid
State agencies would have sufficient access to the provider or
supplier's billing information and Medicare claims processing data to
determine the amount charged to the beneficiary. Accordingly, we are
proposing at Sec. 405.1006(d)(2)(ii) that for any items or services
for which a beneficiary has been determined to be financially
responsible, the basis for the amount in controversy is the actual
amount charged to the beneficiary (or the maximum amount the
beneficiary may be charged if no bill has been received) for the items
or services in the disputed claim. As discussed above, this amount
would be set forth on the Medicare Summary Notice in the column titled
``Maximum You May Be Billed.''
We are also proposing at Sec. 405.1006(d)(2)(iii) that if a
beneficiary received or may be entitled to a refund of the amount the
beneficiary previously paid to the provider or supplier for the items
or services in the disputed claim under applicable statutory or
regulatory authorities, the basis for the amount in controversy would
be the actual amount originally charged to the beneficiary for the
items or services in the disputed claim, as we believe that the amount
originally charged to the beneficiary is more reflective of the actual
amount at issue for the beneficiary and for the provider or supplier in
this situation. We believe appellants would have access to and would
use the same information for determining the basis for the amount in
controversy under paragraph Sec. 405.1006(d)(2)(iii) as they would
under Sec. 405.1006(d)(2)(ii).
As discussed above, we are proposing at Sec. 405.1006(d)(3)
through (7) five exceptions to the general methodology used to
calculate the amount in controversy specified in Sec. 405.1006(d)(1).
Current Sec. 405.1006(d)(2) provides that, notwithstanding current
Sec. 405.1006(d)(1), when payment is made for items or services under
section 1879 of the Act or Sec. 411.400, or the liability of the
beneficiary for those services is limited under Sec. 411.402, the
amount in controversy is computed as the amount that the beneficiary
would have been charged for the items or services in question if those
expenses were not paid under Sec. 411.400 or if that liability was not
limited under Sec. 411.402, reduced by any deductible and coinsurance
amounts applicable in the particular case. We are proposing to re-
designate current Sec. 405.1006(d)(2) as Sec. 405.1006(d)(3) and to
revise the paragraph to state that when payment is made for items or
services under section 1879 of the Act or Sec. 411.400, or the
liability of the beneficiary for those services is limited under Sec.
411.402, the amount in controversy would be calculated in accordance
with Sec. 405.1006(d)(1) and (2)(i), except there is no deduction
under paragraph (d)(1)(i) for expenses that are paid under Sec.
411.400 or as a result of liability that is limited under Sec.
411.402. For example, when a claim for items or service is denied under
section 1862(a)(1)(A) of the Act because the items or services were not
reasonable and necessary for the treatment of illness or injury or to
improve the functioning of a malformed body member, Medicare payment
may nonetheless be made under the limitation on liability provisions of
Sec. 1879 of the Act if neither the provider/supplier nor the
beneficiary knew, or could reasonably have been expected to know, that
payment would not be made. In instances such as these, we are proposing
that the amount in controversy would be calculated as if the items or
services in the disputed claim were denied and no payment had been made
under section 1879 of the Act. We believe this exception is appropriate
because appellants may still wish to appeal findings of non-coverage
related to items and services for which liability of the party was
limited or payment was made under section 1879 of the Act or Sec.
411.400 or for which the beneficiary was indemnified under Sec.
411.402, but if these payments or indemnifications were deducted from
the basis for the amount in controversy, the amount in controversy
could be zero. As this exception relates only to whether deductions are
made under Sec. 405.1006(d)(1)(i) for any Medicare payments already
made or awarded for the items or service, and the amount in controversy
would otherwise be calculated in accordance with proposed Sec.
405.1006(d)(1) and (d)(2)(i), we believe appellants would have access
to and would use the same information for determining the amount in
controversy under Sec. 405.1006(d)(3) as they would under Sec.
405.1006(d)(1) and (d)(2)(i).
Current Sec. 405.1006 does not address calculating the amount in
controversy for matters involving a provider or supplier termination of
a Medicare-covered item or service when the beneficiary did not elect
to continue receiving the item or service (for example, Sec.
405.1206(g)(2) provides that if a beneficiary is dissatisfied with a
QIO's determination on his or her discharge and is no longer an
inpatient in a hospital, the determination is subject to the general
claims appeal process). In this circumstance, items and services have
not been furnished, and therefore, a claim has not been submitted. Yet
the beneficiary may elect not to continue receiving items or services
while appealing the provider or supplier termination due to potential
financial responsibility for the items or services. While an amount in
controversy cannot be assessed for a period of time during which no
items or services were furnished, a beneficiary may assert a continuing
need for the items or services based on his or her condition at the
time an appeal is heard. To address this circumstance, we are proposing
new Sec. 405.1006(d)(4), which would provide that when a matter
involves a provider or supplier
[[Page 43807]]
termination of Medicare-covered items or services and the beneficiary
did not elect to continue receiving the items or services that are
disputed by a beneficiary, the amount in controversy is calculated as
discussed above regarding proposed (d)(1) and (d)(2)(ii) (which
addresses situations where the beneficiary is determined to be
financially responsible), except that the basis for the amount in
controversy and any deductible and coinsurance that may be collected
for the items or services are calculated using the amount the
beneficiary would have been charged if the beneficiary had received the
items or services that the beneficiary asserts should be covered by
Medicare based on the beneficiary's current condition at the time an
appeal is heard, and Medicare payment was not made. This proposal would
allow the beneficiary to pursue coverage for an item or service and
potentially meet the amount in controversy requirement in instances in
which he or she would not otherwise be able to pursue a hearing before
an ALJ because no items or services have been rendered and therefore no
amount in controversy exists because there is no disputed claim. In
these instances, the beneficiary has been notified of a preliminary
decision by a provider or supplier that Medicare will not cover
continued provision of the items or services in dispute. Therefore, we
believe using the amount the beneficiary would be charged if the
beneficiary elected to continue receiving the items or services that
the beneficiary asserts should be covered and if Medicare payment were
not made for these items or services (in other words, the amount the
beneficiary would be charged if the beneficiary were financially
responsible for these items or services) is most reflective of the
actual amount in dispute. Most beneficiary appeals of provider or
supplier terminations of Medicare-covered items or services involve the
termination of Part A services and, therefore, we expect it would be
rare that the amount in controversy would be less than that required
for an ALJ hearing. However, we expect that beneficiaries wishing to
determine if the amount in controversy required for an ALJ hearing was
met could obtain from the provider or supplier the amount the
beneficiary would be charged if the beneficiary elected to continue
receiving the items or services and Medicare payment were not made. In
addition, as discussed below, we are proposing at Sec. 405.976(b)(7)
that the QIC would include in its notice of reconsideration a statement
of whether the amount in controversy is estimated to meet or not meet
the amount required for an ALJ hearing, if the request for
reconsideration was filed by a beneficiary who is not represented by a
provider, supplier, or Medicaid State agency, and the reconsideration
decision was partially or fully unfavorable.
We considered using Medicare payable amounts for denied items and
services as the basis for the amount in controversy calculation
specified in proposed Sec. 405.1006(d)(1), as that would be a more
precise estimate of the amount at issue in the appeal than either the
Medicare allowable amount or the billed charges. Payable amounts would
take into account payment rules related to the items and services
furnished that may increase or decrease allowable amounts (for example,
multiple surgery reductions, incentive payments, and competitive
bidding payments). However, CMS systems do not currently calculate
payable amounts for denied services, and undertaking major system
changes would delay implementation and has been determined not to be
cost effective. While payable amounts may be a better representation of
the amount at issue in the appeal, we believe the Medicare allowable
amount and the other amount in controversy calculations provided in
proposed Sec. 405.1006(d) are appropriate and reliable estimates that
align well with the amount at issue for claims for which a payable
amount has not been calculated.
However, for post-payment denials, or overpayments, a payable
amount has been determined and would be the most reliable indicator of
the amount actually at issue in the appeal. Therefore, we are proposing
new Sec. 405.1006(d)(5) to state that, notwithstanding the calculation
methodology in proposed paragraphs (d)(1) and (2), when a claim appeal
involves an overpayment determination, the amount in controversy would
be the amount of the overpayment specified in the demand letter. In a
post-payment denial, the amount of the overpayment identified in the
demand letter is readily available to appellants, and is the most
accurate reflection of the amount actually at issue in the appeal. In
addition, current Sec. 405.1006 does not address appeals that involve
an estimated overpayment amount determined through the use of sampling
and extrapolation. In this circumstance, the claims sampled to
determine the estimated overpayment may not individually meet the
amount in controversy requirement, but the estimated overpayment
determined through the use of extrapolation may meet the amount in
controversy requirement. To address this circumstance, we are also
proposing in new Sec. 405.1006(d)(5) that when a matter involves an
estimated overpayment amount determined through the use of sampling and
extrapolation, the estimated overpayment as extrapolated to the entire
statistical sampling universe is the amount in controversy. This
proposal would provide appellants the opportunity to appeal claims that
may not individually meet the amount in controversy requirement if such
claims were part of the sample used in making an overpayment
determination that does meet the amount in controversy requirement.
Because the overpayment determination reflects the amount for which the
appellant is financially responsible, we believe it would be
appropriate to allow appellants to appeal individual claims in the
sample that was used to determine the overpayment. Whether an appeal
involves an individual overpayment or an estimated overpayment
determined through the use of sampling and extrapolation, we believe
appellants against whom an overpayment was assessed would need only to
consult the demand letter they received in order to determine the
amount in controversy. However, we expect there may be circumstances
where a beneficiary wishes to appeal an overpayment that was assessed
against a provider or supplier, and in these situations the beneficiary
may not have a copy of the demand letter that was received by the
provider or supplier. For this reason, and as discussed below, we are
proposing at Sec. 405.976(b)(7) that the QIC would include in its
notice of reconsideration a statement of whether the amount in
controversy is estimated to meet or not meet the amount required for an
ALJ hearing, if the request for reconsideration was filed by a
beneficiary who is not represented by a provider, supplier, or Medicaid
State agency, and the reconsideration decision was partially or fully
unfavorable. We are also proposing new Sec. 405.1006(d)(6), which
would provide that when a beneficiary files an appeal challenging only
the computation of a coinsurance amount, or the amount of a remaining
deductible applicable to the items or services in the disputed claim,
the amount in controversy is the difference between the amount of the
coinsurance or remaining deductible, as determined by the contractor,
and the amount of the coinsurance or remaining deductible the
beneficiary believes is correct. We believe this provision is
appropriate in these instances because,
[[Page 43808]]
without this provision, the amount in controversy determined under the
general calculation methodology in Sec. 405.1006(d)(1) would be zero
for a paid claim. In addition, we believe that the calculation proposed
at Sec. 405.1006(d)(6) would appropriately reflect the amount at issue
for the beneficiary in these appeals where the computation of a
coinsurance amount, or the amount of a remaining applicable deductible
is challenged. We believe beneficiaries would have access to the
coinsurance and/or deductible amounts determined by the contractor for
the paid claim on the beneficiary's Medicare Summary Notice, in the
column titled ``Maximum You May Be Billed,'' and would need only to
subtract the amount of coinsurance and/or deductible the beneficiary
believes he or she should have been charged in order to arrive at the
amount in controversy. We expect it would be extremely rare for a non-
beneficiary appellant to file an appeal challenging the computation of
a coinsurance amount or the amount of a remaining deductible.
In addition, we are proposing new Sec. 405.1006(d)(7), which would
provide that for appeals of claims where the allowable amount has been
paid in full and the appellant is challenging only the validity of the
allowable amount, as reflected in the published Medicare fee schedule
or in the published contractor priced amount applicable to the items or
services in the disputed claim, the amount in controversy is the
difference between the amount the appellant argues should have been the
allowable amount for the items or services in the disputed claim in the
applicable jurisdiction and place of service, and the published
allowable amount for the items or services. We believe this provision
is appropriate in these instances because, without this provision, the
amount in controversy determined under the general calculation
methodology in Sec. 405.1006(d)(1) would be zero for such paid claims.
In addition, we believe that the calculation proposed at Sec.
405.1006(d)(7) would appropriately reflect the amount at issue for the
appellant in these appeals. We believe that, generally, these types of
appeals are filed by providers and suppliers who are already familiar
with the allowable amount for the items or services in the disputed
claim based on information obtained from published fee schedules or
contractor-priced amounts. Further, we believe that a fee schedule or
contractor price challenge filed by a beneficiary on a paid claim would
be a very rare occurrence. However, as discussed below, in the event a
beneficiary would want to file such an appeal, the beneficiary could
obtain an estimate of the amount in controversy from the QIC
reconsideration. As discussed further below, we are proposing at Sec.
405.976(b)(7) that the QIC would include in its notice of
reconsideration a statement of whether the amount in controversy is
estimated to meet or not meet the amount required for an ALJ hearing,
if the request for reconsideration was filed by a beneficiary who is
not represented by a provider, supplier, or Medicaid State agency, and
the reconsideration decision was partially or fully unfavorable.
In the event that a reconsideration, or a redetermination if the
appeal was escalated from the QIC without a reconsideration, involves
multiple claims and some or all do not meet the amount in controversy
requirement, section 1869 of the Act states that, in determining the
amount in controversy, the Secretary, under regulations, shall allow
two or more appeals to be aggregated if the appeals involve the
delivery of similar or related services to the same individual by one
or more providers or suppliers, or common issues of law and fact
arising from services furnished to two or more individuals by one or
more providers or suppliers. Under this authority, Sec. 405.1006(e)
provides for aggregating claims to meet the amount in controversy
requirement.
The title of current Sec. 405.1006(e)(1) for aggregating claims
when appealing a QIC reconsideration is phrased differently than the
corresponding title for aggregating claims when escalating a request
for a QIC reconsideration in current Sec. 405.1006(e)(2), which may
cause confusion. We are proposing to revise the title to Sec.
405.1006(e)(1) to ``Aggregating claims in appeals of QIC
reconsiderations for an ALJ hearing'' so it clearly applies to
aggregating claims in appeals of QIC reconsiderations, and is parallel
to the phrasing used in the title of Sec. 405.1006(e)(2). The proposed
titles of Sec. 405.1006(e)(1) and (e)(2), and proposed Sec.
405.1006(e)(2)(ii) would also replace ``to the ALJ level'' with ``for
an ALJ hearing'' to again highlight that the appeal of a QIC
reconsideration or escalation of a request for a QIC reconsideration is
for an ALJ hearing.
Current Sec. 405.1006(e)(1)(ii) provides that to aggregate claims,
the request for ALJ hearing must list all of the claims to be
aggregated. This has caused confusion because some appellants read
current Sec. 405.1006(e)(1)(ii) as allowing appeals of new claims to
be aggregated with claims in previously filed appeals, provided the new
request for hearing lists the claims involved in the previously filed
appeals. However, current Sec. 405.1006(e)(2)(i), which applies to
aggregating claims that are escalated from the QIC for a hearing before
an ALJ, requires that the claims were pending before the QIC in
conjunction with the same request for reconsideration. We note that in
the context of a request for hearing, aggregating new claims with
claims from previously filed requests could delay the adjudication of
the requests and is inconsistent with the current rule for aggregating
claims that are escalated from the QIC. To address these issues and
bring consistency to the aggregation provisions, we are proposing to
revise Sec. 405.1006(e)(1)(ii) to require the appellant(s) to request
aggregation of the claims in the same request for ALJ hearing or in
multiple requests for an ALJ hearing filed with the same request for
aggregation. This would allow an individual or multiple appellants to
file either one request for an ALJ hearing for multiple claims to be
aggregated, or multiple requests for an ALJ hearing for the appealed
claims when requesting aggregation, while requiring them to be filed
together with the associated request for aggregation. We are also
proposing in Sec. 405.1006(e)(1)(iii) and (e)(2)(iii) that an ALJ or
attorney adjudicator may determine that the claims that a single
appellant seeks to aggregate involve the delivery of similar or related
services, or the claims that multiple appellants seek to aggregate
involve common issues of law and fact, but only an ALJ may determine
the claims that a single appellant seeks to aggregate do not involve
the delivery of similar or related services, or the claims that
multiple appellants seek to aggregate do not involve common issues of
law and fact. We are proposing this because an attorney adjudicator
adjudicating requests for an ALJ hearing when no hearing is conducted,
as proposed in section II.B above, would not be permitted under this
proposed rule to dismiss a request for an ALJ hearing due to procedural
issues such as an invalid aggregation request. Because only an ALJ
would be permitted to dismiss a request for an ALJ hearing because
there is no right to a hearing, which includes not meeting the amount
in controversy requirement for a hearing, in accordance with proposed
Sec. 405.1052(a), an attorney adjudicator could not make a
determination that the aggregation criteria were not met because that
determination would result
[[Page 43809]]
in a dismissal of a request for an ALJ hearing.
Current Sec. 405.976(b)(7) requires that the QIC notice of
reconsideration contain a statement of whether the amount in
controversy needed for an ALJ hearing is met when the reconsideration
is partially or fully unfavorable. We are proposing to revise Sec.
405.976(b)(7) to require that the QIC notice of reconsideration include
a statement of whether the amount in controversy is estimated to meet
or not meet the amount required for an ALJ hearing only if the request
for reconsideration was filed by a beneficiary who is not represented
by a provider, supplier, or Medicaid State agency, and the
reconsideration is partially or fully unfavorable. In line with current
practice, we are not proposing to require that the QIC indicate what it
believes to be the exact amount in controversy, but rather only an
estimate of whether it believes the amount in controversy is met,
because we believe the ultimate responsibility for determining whether
the amount in controversy required for an ALJ hearing is met lies with
appellants, subject to verification by an ALJ or attorney adjudicator
(though, as discussed in section II.B above, only an ALJ would be able
to dismiss a request for hearing for failure to meet the amount in
controversy required for an ALJ hearing). We believe that providers,
suppliers, and Medicaid State agencies have the tools, resources, and
payment information necessary to calculate the amount in controversy in
accordance with Sec. 405.1006(d), and are familiar with the allowable
amounts for the places of service in which they operate. Furthermore,
applicable plans against whom a Medicare Secondary Payer overpayment is
assessed would have access to the overpayment amount specified in the
demand letter, which would be used to determine the amount in
controversy under proposed Sec. 405.1006(d)(5). Thus, we do not
believe it is necessary for the QICs to continue to provide this
statement for providers, suppliers, applicable plans, Medicaid State
agencies, or beneficiaries represented by providers, suppliers or
Medicaid State agencies. Furthermore, as discussed in section
III.A.3.g.i below, we are proposing that appellants, other than
beneficiaries who are not represented by a provider, supplier, or
Medicaid State agency, include the amount in controversy in their
requests for hearing (unless the matter involves a provider or supplier
termination of Medicare-covered items or services that is disputed by a
beneficiary, and the beneficiary did not elect to continue receiving
the items or services). As providers, suppliers, Medicaid State
agencies, applicable plans, and beneficiaries represented by a
provider, supplier, or Medicaid State agency would be responsible for
calculating the amount in controversy and including it on the request
for hearing as proposed in section III.A.3.g.i, we do not believe a
statement by the QIC that indicates only whether the amount in
controversy was or was not met adds significant value to such
appellants. Furthermore, we expect that the Medicare allowable amount
under proposed Sec. 405.1006(d)(2)(i)(A) would be the basis for the
amount in controversy in the majority of Part B appeals filed by non-
beneficiary appellants. While QICs have access to the amount charged to
an individual based on billed charges, the allowable amounts for claims
vary based on where these items and services were furnished, and the
applicable fee schedules and contractor-priced amounts, and continuing
to require the QICs to include a statement whether the amount in
controversy needed for an ALJ hearing is met in all instances in which
the decision is partially or fully unfavorable to the appellant would
require substantially more work by the QIC, and could delay
reconsiderations and increase costs to the government.
Although we are not proposing that beneficiaries who are not
represented by a provider, supplier, or Medicaid State agency would
need to include the amount in controversy on their requests for hearing
(as discussed later in this preamble), we do believe there may be
instances where a beneficiary would want to know if the amount in
controversy meets the amount required for an ALJ hearing when deciding
whether to file a request for hearing. We believe there may be
instances where a beneficiary who is not represented by a provider,
supplier, or Medicaid State agency may not currently have sufficient
information to determine whether the amount in controversy required for
an ALJ hearing is met under proposed Sec. 405.1006. For example, under
proposed Sec. 405.1006(d)(2)(i)(A), for items and services with a
published Medicare fee schedule or published contractor-priced amount
(and for which the beneficiary was determined to be not financially
responsible), the basis for the amount in controversy would generally
be the allowable amount, which is the amount reflected on the fee
schedule or in the contractor-priced amount for those items or services
in the applicable jurisdiction and place of service. Beneficiaries not
represented by a provider, supplier, or Medicaid State agency would not
generally be expected to be familiar with fee schedule and contractor-
priced amounts, and we believe they may have difficulty determining
whether the amount in controversy required for an ALJ hearing is met in
these cases. We also believe beneficiaries not represented by a
provider, supplier, or Medicaid State agency might be unable to
determine the amount of an overpayment assessed against a provider or
supplier for items or services furnished to the beneficiary for
purposes of calculating the amount in controversy under proposed Sec.
405.1006(d)(5), as the beneficiary might not have access to the demand
letter received by the provider or supplier, and may no longer have
access to the Medicare Summary Notice reflecting the original payment
amount. Accordingly, because there are situations where such
beneficiaries may not have sufficient information to determine the
amount in controversy, we are proposing to revise Sec. 405.976(b)(7)
to state that the QIC would include in its notice of reconsideration a
statement of whether the amount in controversy is estimated to meet or
not meet the amount required for an ALJ hearing, if the request for
reconsideration was filed by a beneficiary who is not represented by a
provider, supplier, or Medicaid State agency, and the reconsideration
decision was partially or fully unfavorable.
Current Sec. 423.1970 describes the amount in controversy
requirement for part 423, subpart U proceedings. For the same reasons
we are proposing to revise Sec. 405.1006(e)(1)(ii), we are proposing
in Sec. 423.1970(c)(1)(ii) and (c)(2)(ii) to provide that a single
enrollee's or multiple enrollees' request for aggregation,
respectively, must be filed at the same time the request (or requests)
for hearing for the appealed reconsiderations is filed. In addition, we
are proposing to revise Sec. 423.1970(c)(1)(ii) and Sec.
423.1970(c)(2)(ii) to state that the request for aggregation and
requests for hearing must be filed within 60 calendar days after
receipt of the notice of reconsideration for each reconsideration being
appealed, unless the deadline is extended in accordance with Sec.
423.2014(d). This will help ensure there is no confusion that the
timely filing requirement applies to each of the requests for hearing
filed with the request for aggregation. Because we are proposing to
directly reference the 60 calendar day filing requirement under
[[Page 43810]]
Sec. 423.1972(b) and the possible extension of the filing requirement
under Sec. 423.2014(d), we are also proposing to remove the current
references in Sec. 423.1970(c)(1)(ii) and (c)(2)(ii) to the filing
requirement in Sec. 423.1972(b). In addition, for the same reasons we
are proposing to revise Sec. 405.1006(e)(1)(iii) and (e)(2)(iii), we
are proposing in Sec. 423.1970(c)(1)(iii) and (c)(2)(iii) that an ALJ
or attorney adjudicator may determine that the appeals that a single
enrollee seeks to aggregate involve the delivery of prescription drugs
to a single enrollee, or the appeals that multiple enrollees seek to
aggregate involve the same prescription drugs, but only an ALJ may
determine appeals that a single enrollee seeks to aggregate do not
involve the delivery of prescription drugs to a single enrollee, or the
appeals that multiple enrollees seek to aggregate do not involve the
same prescription drugs. We are proposing to replace ``prescription''
in current Sec. 423.1970(c)(2)(iii) with ``prescription drugs'' in
proposed Sec. 423.1970(c)(2)(iii) for consistency with current and
proposed Sec. 423.1970(c)(1)(iii). Finally, we are also proposing to
correct the spelling of ``prescription'' in current Sec.
423.1970(c)(2)(iii).
Current Sec. 422.600(b) provides that the amount in controversy
for appeals of reconsidered determinations to an ALJ (under the Part C
Medicare Advantage program), is computed in accordance with part 405.
However, if the basis for the appeal is the MAO's refusal to provide
services, current Sec. 422.600(c) provides that the projected value of
those services are used to compute the amount in controversy. We are
not proposing to revise these provisions because we believe the
proposed revisions to Sec. 405.1006 described above encompass and have
application to the scenarios appealed under part 422, subpart M. In
particular, we note that as is the case under current Sec. 405.1006,
if an enrollee received items or services and is financially
responsible for payment because the MAO has refused to cover the item
or services, the amount in controversy would be calculated using the
billed charges as the basis for the amount in controversy, as provided
in proposed Sec. 405.1006(d)(2)(ii). If the enrollee did not receive
the items or services, the provisions of current Sec. 422.600(c) would
apply. We also note that current Sec. Sec. 422.622(g)(2) and
422.626(g)(3) provides for an appeal to an ALJ, the Council, or federal
court of an IRE's affirmation of a termination of provider services
``as provided for under [part 422, subpart M],'' thus triggering the
amount in controversy rules in 422.600, which cross-reference part 405
(that is, the rules proposed here). Proposed Sec. 405.1006 would
address scenarios appealed under part 422, subpart M that are not
clearly addressed in current Sec. 405.1006, such as provider service
terminations, which would be addressed in proposed Sec.
405.1006(d)(4), and coinsurance and deductible challenges, which would
be addressed in proposed Sec. 405.1006(d)(6).
Current Sec. 478.44(a) also references back to part 405 provisions
for determining the amount in controversy when requesting an ALJ
hearing after a QIO reconsidered determination. We have proposed
revisions to Sec. 478.44 in section III.D.3, below, to update part 405
references, but we are not proposing in Sec. 478.44 to revise how the
current or proposed part 405 provision would be applied in calculating
the amount in controversy. Similar to the part 422, subpart M
provisions discussed above, we believe the proposed revisions to Sec.
405.1006 described above encompass and have application to the
scenarios appealed under part 478, subpart B.
We are inviting public comments on these proposals. If you choose
to comment on issues in this section, please include the caption
``Amount in controversy required for an ALJ hearing'' at the beginning
of your comment.
e. Parties to an ALJ Hearing (Sec. Sec. 405.1008 and 423.2008)
Current Sec. Sec. 405.1008 and 423.2008 discuss the parties to an
ALJ hearing. Because current Sec. Sec. 405.1002(a) and 423.2002(a)
already address who may request a hearing before an ALJ after a QIC or
IRE issues a reconsideration and current Sec. 405.1002(b) addresses
who may request escalation of a request for a QIC reconsideration, we
are proposing to remove current Sec. Sec. 405.1008(a) and 423.2008(a).
We are proposing to retain and revise the language as discussed
below in current Sec. Sec. 405.1008(b) and 423.2008(b), but remove the
paragraph designation. Current Sec. Sec. 405.1008(b) and 423.2008(b)
identify the parties ``to the ALJ hearing,'' but this could be read to
be limited to parties to an oral hearing, if a hearing is conducted. To
address this potential confusion, we are proposing to revise Sec. Sec.
405.1008 and 423.2008 to replace ``parties to an ALJ hearing'' with
``parties to the proceedings on a request for an ALJ hearing'' and
``party to the ALJ hearing'' with ``party to the proceedings on a
request for an ALJ hearing.'' Likewise, we also are proposing to revise
the titles to Sec. Sec. 405.1008 and 423.2008 from ``Parties to an ALJ
hearing'' to ``Parties to the proceedings on a request for an ALJ
hearing.''
We are inviting public comments on these proposals. If you choose
to comment the proposals in this section, please include the caption
``Parties to an ALJ hearing'' at the beginning of your comment.
f. CMS and CMS Contractors as Participants or Parties in the
Adjudication Process (Sec. Sec. 405.1010, 405.1012, and 423.2010)
Consistent with section 1869(c)(3)(J) of the Act, Sec. Sec.
405.1010 and 405.1012 allow CMS and its contractors to elect to be a
participant or a party to a Part A or Part B hearing before an ALJ.
Current Sec. 423.1010 allows CMS, a Part D plan sponsor, or an IRE to
request to be a participant in the proceedings of a Part D hearing
before an ALJ. Since current Sec. Sec. 405.1010, 405.1012, and
423.2010 were added, CMS and its contractors, including the Part D IRE,
and Part D plan sponsors, have assisted the ALJ hearing process by
clarifying factual and policy issues, which provides ALJs with more
information to resolve the issues on appeals. However, as we have
gained experience with CMS and these entities as participants and
parties to hearings, we have heard from ALJs and stakeholders that
additional parameters are needed to help ensure hearings with the
entities are as efficient as possible; expectations and roles are
clear; and the entities have an opportunity to assist with appeals for
which no hearing is conducted.
Therefore, we are proposing significant revisions to Sec. Sec.
405.1010, 405.1012, and 423.2010 to achieve these objectives.
Proposed Sec. Sec. 405.1010 (When CMS or its contractors may
participate in the proceedings on a request for an ALJ hearing),
405.1012 (When CMS or its contractors may be a party to a hearing), and
423.2010 (When CMS, the IRE, or Part D plan sponsor may participate in
the proceedings on a request for an ALJ hearing) would be reorganized
and aligned for clarity, and revised to improve the participation
process. The proposed revised sections would be similarly structured to
address when an entity may elect or request to participate in the
proceedings on a request for an ALJ hearing, or be a party to a
hearing; how elections or requests are made; the roles and
responsibilities of CMS and its contractors; limitations on hearing
participation; and invalid elections or requests.
[[Page 43811]]
i. Section 405.1010: When CMS or Its Contractors May Participate in the
Proceedings on a Request for an ALJ Hearing
Current Sec. 405.1010(a) provides that an ALJ may request, but may
not require, CMS and/or its contractors to participate in any
proceedings before the ALJ, including the oral hearing, if any, and CMS
or its contractors may elect to participate in the hearing process.
Under current Sec. 405.1010(b), if that election is made, CMS or its
contractor must advise the ALJ, the appellant, and all other parties
identified in the notice of hearing of its intent to participate no
later than 10 calendar days after receiving the notice of hearing.
Section 405.1010(c) sets forth what participation includes and Sec.
405.1010(d) states that participation does not include CMS or its
contractor being called as a witness during the hearing. Section
405.1010(e) requires CMS or its contractors to submit any position
papers within the time frame designated by the ALJ. Finally, Sec.
405.1010(f) states that the ALJ cannot draw any adverse inferences if
CMS or a contractor decides not to participate in any proceedings
before an ALJ, including the hearing.
The reference to the period in which an election to participate
must be filed beginning upon receipt of the notice of hearing in
current Sec. 405.1010(b) has caused confusion when CMS or its
contractors attempt to enter proceedings before a hearing is scheduled,
or when no notice of hearing is necessary because an appeal may be
decided on the record. To help ensure that CMS and its contractors have
the opportunity to enter the proceedings with minimal disruption to the
adjudication process prior to a hearing being scheduled or when a
hearing may not be conducted, we are proposing in Sec. 405.1010(a)(1)
to provide that CMS or its contractors may elect to participate in the
proceedings on a request for an ALJ hearing upon filing a notice of
intent to participate in accordance with paragraph (b), at either of,
but not later than, two distinct points in the adjudication process
described in paragraph (b)(3).
As provided in current Sec. 405.1010(a) and (f), we are proposing
at Sec. 405.1010(a)(2) that an ALJ may request but may not require CMS
and/or one or more of its contractors to participate in any proceedings
before the ALJ, including the oral hearing, if any; and the ALJ cannot
draw any adverse inferences if CMS or the contractor decides not to
participate in the proceedings.
We are proposing in Sec. 405.1010(b) to address how CMS or a
contractor makes an election to participate in an appeal, before or
after receipt of a notice of hearing or when a notice of hearing is not
required. Under proposed Sec. 405.1010(b)(1), we are proposing that if
CMS or a contractor elects to participate before receipt of a notice of
hearing (such as during the 30 calendar day period after being notified
that a request for hearing was filed as proposed in Sec.
405.1010(b)(3)(i)) or when a notice of hearing is not required, CMS or
the contractor must send written notice of its intent to participate to
the parties who were sent a copy of the notice of reconsideration, and
to the assigned ALJ or attorney adjudicator, as proposed in section
II.B above, or if the appeal is not yet assigned, to a designee of the
Chief ALJ. Proposed Sec. 405.1010(b)(1) would provide for sending the
written notice of intent to participate to an ALJ or attorney
adjudicator assigned to an appeal because, as we discuss in proposed in
section II.B, an attorney adjudicator also would have the authority to
issue decisions on a request for an ALJ hearing when no hearing is
conducted, and in accordance with proposed Sec. 405.1010, CMS or its
contractors are permitted to participate in the proceedings on such a
request. Proposed Sec. 405.1010(b)(1) would also provide for sending
the notice of intent to participate to a designee of the Chief ALJ if a
request for an ALJ hearing is not yet assigned to an ALJ or attorney
adjudicator because CMS or a contractor could file an election to be a
participant in the proceedings before the assignment process is
complete. Proposed Sec. 405.1010(b)(1) would help ensure that the
potential parties to a hearing, if a hearing is conducted, would
receive notice of the intent to participate, and also help ensure that
adjudicators who are assigned to an appeal after an election is made
would be aware of the election. Because only an ALJ may conduct a
hearing and the parties to whom a notice of hearing is sent may differ
from the parties who were sent a copy on the notice of reconsideration,
we are proposing at Sec. 405.1010(b)(2) that if CMS or a contractor
elects to participate after receiving a notice of hearing, CMS or the
contractor would send written notice of its intent to participate to
the ALJ and the parties who were sent a copy of the notice of hearing.
Under proposed Sec. 405.1010(b)(3)(i), CMS or a contractor would
have an initial opportunity to elect to be a participant in an appeal
within 30 calendar days after notification that a request for hearing
has been filed with OMHA, if no hearing is scheduled. CMS and its
contractors have the capability to see that a QIC reconsideration had
been appealed to OMHA in the case management system used by QICs. This
system would provide constructive notice to the QICs when the system
indicates an appeal has been filed with OMHA, which OMHA can monitor
through the date that the reconsideration data is transferred to OMHA
to adjudicate the request for an ALJ hearing. Under proposed Sec.
405.1010(b)(3)(ii), a second opportunity to elect to be a participant
in an appeal would become available if a hearing is scheduled; as in
the current rule, CMS or a contractor would have 10 calendar days after
receiving the notice of hearing to make the election.
We considered allowing CMS or a contractor to make an election at
any time prior to a decision being issued if a hearing was not
scheduled, or sending a notice that a decision would be issued without
a hearing and establishing an election period after such notice.
However, both of these options would disrupt and delay the adjudication
process, as well as add administrative burdens on OMHA. We believe the
30 calendar day period after notification that a request for hearing
was filed is sufficient time for CMS or a contractor to determine
whether to elect to be a participant in the appeal while the record is
reviewed for case development and to prepare for the hearing, or
determine whether a decision may be appropriate based on the record in
accordance with Sec. 405.1038.
We are proposing to consolidate current Sec. 405.1010(c) through
(e) in proposed Sec. 405.1010(c) to address the roles and
responsibilities of CMS or a contractor as a participant. Proposed
Sec. 405.1010(c)(1) would incorporate current Sec. 405.1010(c), which
provides that participation may include filing position papers or
providing testimony to clarify factual or policy issues, but it does
not include calling witnesses or cross-examining a party's witnesses.
However, we are proposing to revise Sec. 405.1010(c) to state in Sec.
405.1010(c)(1) that participation may include filing position papers
``and/or'' providing testimony to emphasize that either or both may be
done, and to state that participation would be subject to proposed
Sec. 405.1010(d)(1) through (3) (discussed below). We are proposing to
incorporate current Sec. 405.1010(d) in proposed Sec. 405.1010(c)(2)
to provide that when CMS or a contractor participates in a hearing,
they may not be called as witnesses and, thus, are not
[[Page 43812]]
subject to examination or cross-examination by parties to the hearing.
However, to be clear about how a party and the ALJ may address
statements made by CMS or a contractor during the hearing given that
limitation, we also are proposing in Sec. 405.1010(c)(2) that the
parties may provide testimony to rebut factual or policy statements
made by the participant, and the ALJ may question the participant about
the testimony.
We are proposing to incorporate current Sec. 405.1010(e) in
proposed Sec. 405.1010(c)(3) with certain revisions as discussed
below. Current Sec. 405.1010(e) states that CMS or its contractor must
submit any position papers within the time frame designated by the ALJ.
We are proposing in Sec. 405.1010(c)(3) to include written testimony
in the provision, establish deadlines for submission of position papers
and written testimony that reflect the changes in participation
elections in proposed 405.1010(b), and require that copies of position
papers and written testimony be sent to the parties. Specifically, we
are proposing in Sec. 405.1010(c)(3)(i) that CMS or a contractor
position paper or written testimony must be submitted within 14
calendar days of an election to participate if no hearing has been
scheduled, or no later than 5 calendar days prior to the scheduled
hearing unless additional time is granted by the ALJ. We are proposing
to add ``written testimony'' to recognize that CMS or a contractor may
submit written testimony as a participant, in addition to providing
oral testimony at a hearing. We are proposing to require position
papers and written testimony be submitted within 14 calendar days after
an election if no hearing is scheduled to help ensure the position
paper and/or written testimony are available when determinations are
made to schedule a hearing or issue a decision based on the record in
accordance with Sec. 405.1038. We also are proposing to require that
if a hearing is scheduled, position papers and written testimony be
submitted no later than 5 calendar days prior to the hearing (unless
the ALJ grants additional time) to help ensure the ALJ and the parties
have an opportunity to review the materials prior to the hearing.
Additionally, under proposed Sec. 405.1010(c)(3)(ii), CMS or a
contractor would need to send a copy of any position paper or written
testimony submitted to OMHA to the parties who were sent a copy of the
notice of reconsideration if the position paper or written testimony is
submitted to OMHA before receipt of a notice of hearing, or to the
parties who were sent a copy of the notice of hearing if the position
paper or written testimony is submitted after receipt of a notice of
hearing. Current Sec. 405.1010 does not address the repercussions of a
position paper not being submitted in accordance with the section.
Therefore, we are proposing in Sec. 405.1010(c)(3)(iii) that a
position paper or written testimony would not be considered in deciding
an appeal if CMS or a contractor fails to send a copy of its position
paper or written testimony to the parties, or fails to submit its
position paper or written testimony within the established time frames.
This would help ensure CMS or contractor position papers and written
testimony are submitted timely and shared with the parties.
Current Sec. Sec. 405.1010 does not limit the number of entities
that may elect to be participants, which currently includes
participating in a hearing if a hearing is conducted, and current Sec.
405.1012 does not limit the number of entities that may elect to be a
party to a hearing. This has resulted in hearings for some appeals
being difficult to schedule and taking longer to conduct due to
multiple elections. To address these issues, we are proposing at Sec.
405.1010(d)(1) that when CMS or a contractor has been made a party to
the hearing under Sec. 405.1012, CMS or a contractor that elected to
be a participant under Sec. 405.1010 may not participate in the oral
hearing, but may file a position paper and/or written testimony to
clarify factual or policy issues in the case (oral testimony and
attendance at the hearing would not be permitted). Similarly, we are
proposing at Sec. 405.1010(d)(1) that CMS or a contractor that elected
to be a party to the hearing, but was made a participant under Sec.
405.1012(d)(1), as discussed below, would also be precluded from
participating in the oral hearing, but would be permitted to file a
position paper and/or oral testimony to clarify factual or policy
issues in the case. We are proposing at Sec. 405.1010(d)(2) that if
CMS or a contractor did not elect to be a party to the hearing under
Sec. 405.1012, but more than one entity elected to be a participant
under Sec. 405.1010, only the first entity to file a response to the
notice of hearing as provided under Sec. 405.1020(c) may participate
in the oral hearing, but additional entities that filed a subsequent
response to the notice of hearing could file a position paper and/or
written testimony to clarify factual or policy issues in the case
(though they would not be permitted to attend the hearing or provide
oral testimony). We are proposing that the first entity to file a
response to the notice of hearing as provided under Sec. 405.1020(c)
may participate in the hearing for administrative efficiency. Under
this approach, if multiple entities elected to participate in the
proceedings prior to the issuance of a notice of hearing, in accordance
with proposed Sec. 405.1010(b)(1), any of these entities wishing to
participate in the oral hearing would need to indicate this intention
in the response to the notice of hearing. If more than one entity
indicated its intention to attend and participate in the oral hearing,
only the first entity to file its response would be permitted to do so.
The remaining entities would be permitted only to file a position paper
and/or written testimony (unless the ALJ grants leave to additional
entities to attend the hearing, as discussed below). We considered an
alternate proposal of the first entity that made an election to
participate being given priority for participating in the hearing, but
believe that would result in other participants being uncertain whether
they will be participating in the hearing until as few as 5 days prior
to the hearing. We also considered a process in which the ALJ would
assess which participant that responded to the notice of hearing would
be most helpful to the ALJ at the hearing, or in the alternative,
permitting all participants to be at the hearing unless the ALJ
determined a participant is not necessary for the hearing, but both of
these approaches would add administrative burden to the ALJ and could
result in participants and parties being uncertain of which
participants will be at the hearing until shortly before the hearing.
We welcome comments on the alternatives considered above, and other
potential alternatives.
Notwithstanding the limitations on CMS and CMS contractor
participation in proposed Sec. 405.1010(d)(1) and (2), proposed Sec.
405.1010(d)(3) would provide the ALJ with the necessary discretion to
allow additional participation in the oral hearing when the ALJ
determines an entity's participation is necessary for a full
examination of the matters at issue. For example, if an appeal involves
LCDs from multiple MAC jurisdictions, the ALJ may determine that
allowing additional MACs to participate in a hearing is necessary for a
full examination of the matters at issue. Similarly, if an overpayment
determined through the use of a statistical sample and extrapolation is
at issue, the ALJ may determine that
[[Page 43813]]
allowing the contractor that conducted the sampling to participate in
the hearing is necessary to address issues related to the sampling and
extrapolation, in addition to another contractor that made an election
to clarify the policy and factual issues related to the merits of
claims in the sample.
Currently, there are no provisions in Sec. 405.1010 to address the
possibility of CMS or a contractor making an invalid election. We are
proposing to revise Sec. 405.1010(e) to add new provisions to
establish criteria for when an election may be deemed invalid and
provide standards for notifying the entity and the parties when an
election is deemed invalid. Proposed Sec. 405.1010(e)(1) would provide
that an ALJ or attorney adjudicator may determine an election is
invalid if the election was not timely filed or the election was not
sent to the correct parties. This would help ensure that CMS and its
contractors make timely elections and inform parties of elections. To
provide notice to the entity and the parties that an election was
deemed invalid, proposed Sec. 405.1010(e)(2) would require a written
notice of an invalid election be sent to the entity that submitted the
election and the parties who are entitled to receive notice of the
election. If no hearing is scheduled for the appeal or the election was
submitted after the hearing occurred, proposed Sec. 405.1010(e)(2)(i)
would provide that the notice of an invalid election be sent no later
than the date the decision, dismissal, or remand notice is mailed. If a
hearing is scheduled for the appeal, proposed Sec. 405.1010(e)(2)(ii)
would provide that the written notice of an invalid election is sent
prior to the hearing, and that if the notice would be sent fewer than 5
calendar days before the hearing is scheduled to occur, oral notice
must be provided to the entity, and the written notice must be sent as
soon as possible after the oral notice is provided.
We are inviting public comments on these proposals. If you choose
to comment on the proposals in this section, please include the caption
``Section 405.1010: When CMS or its contractors may participate in the
proceedings on a request for an ALJ hearing'' at the beginning of your
comment.
ii. Section 423.2010: When CMS, the IRE, or Part D Plan Sponsors May
Participate in the Proceedings on a Request for an ALJ Hearing
Current Sec. 423.2010 is similar to current Sec. 405.1010, except
that CMS, the IRE, or the Part D plan sponsor may only request to
participate, and the time periods to request to participate are shorter
than the time periods to elect to participate under Sec. 405.1010,
which provides the ALJ with time to consider the request to participate
and make a determination on whether to allow participation by the
entity. In addition, current Sec. 423.2010 addresses participation in
Part D expedited appeals. Like proposed Sec. 405.1010(a), we are
proposing at Sec. 423.2010(a) to provide CMS, the IRE, and the Part D
plan sponsor with an opportunity to participate in the proceedings on a
request for an ALJ hearing at two distinct points in the adjudication
process, but the current policy of requiring the entity to request to
participate is maintained. We are proposing at Sec. 423.2010(b)(3)(i)
and (ii) that, if no hearing is scheduled, CMS, the IRE and/or the Part
D plan sponsor would have an initial opportunity to request to be a
participant in an appeal within 30 calendar days after notification
that a standard request for hearing was filed with OMHA, or within 2
calendar days after notification that a request for an expedited
hearing was filed. The initial 30 calendar day period after
notification that a standard request for hearing was filed with OMHA
would be the same time frame provided under Sec. 405.1010 for initial
CMS and contractor elections, and we believe that 30 calendar day
period after notification that a request for hearing was filed is
sufficient time for CMS, the IRE, and the Part D plan sponsor to
determine whether to request to be a participant in the proceedings and
for the request to be considered and granted or denied as the case is
reviewed to determine whether a decision may be appropriate based on
the record in accordance with Sec. 423.2038. We believe the 2 calendar
day period after notification that an expedited request for hearing was
filed is a reasonable period of time for CMS, the IRE, or the Part D
plan sponsor to determine whether to request to be a participant in the
proceedings given the 10-day adjudication time frame. We are proposing
at Sec. 423.2010(b)(3)(iii) and (iv) to provide a second opportunity
to request to be a participant in an appeal if a hearing is scheduled.
We are proposing at Sec. 423.2010(b)(3)(iii) that if a non-expedited
hearing is scheduled, CMS, the IRE, or the Part D plan sponsor would
continue to have 5 calendar days after receiving the notice of hearing
to make the request. We are proposing at Sec. 423.2010(b)(3)(iv) that
if an expedited hearing is scheduled, CMS, the IRE, or the Part D plan
sponsor would continue to have 1 calendar day after receiving the
notice of hearing to make the request. These time frames are carried
over from current Sec. 423.2010(b)(1) and (b)(3), and provide the ALJ
with time to consider the request and notify the entity of his or her
decision on the request to participate. As provided in current Sec.
423.2010(a) and (g), we are proposing at Sec. 423.2010(a)(2) to
provide that an ALJ may request but may not require CMS, the IRE, or
the Part D plan sponsor to participate in any proceedings before the
ALJ, including the oral hearing, if any, and that the ALJ may not draw
any adverse inferences if CMS, the IRE, or the Part D plan sponsor
declines to be a participant to the proceedings.
The standards governing how an election is made in proposed Sec.
405.1010(b) would be adopted in proposed Sec. 423.2010(b) governing
how a request to participate is made, except that an oral request to
participate could be made for an expedited hearing, and OMHA would
notify the enrollee of the request to participate in such cases.
Current Sec. 423.2010(b)(2) and (b)(4) provide that an ALJ will
notify an entity requesting to participate of the decision on the
request within 5 calendar days for a request related to a non-expedited
hearing, or 1 calendar day for a request related to an expedited
hearing. These time frames would be incorporated in proposed Sec.
423.2020(c). In addition, proposed Sec. 423.2020(c)(1) would provide
that if no hearing is scheduled, the notification is made at least 20
calendar days before the ALJ or attorney adjudicator (as proposed in
section II.B above) issues a decision, dismissal, or remand. This would
provide the participant with time to submit a position paper in
accordance with proposed Sec. 423.2010(d)(3)(i), as discussed below.
Current Sec. 423.2010(c) would also be incorporated into proposed
Sec. 423.2010(c), so that the provision clearly states that the
assigned ALJ or attorney adjudicator (as proposed in section II.B
above) has discretion to not allow CMS, the IRE, or the Part D plan
sponsor to participate. Proposed Sec. 423.2010(c) would provide that
an attorney adjudicator as well as the ALJ may make a decision on a
request to participate because a request to participate may be
submitted for appeals that may be assigned to an attorney adjudicator
and those appeals could also benefit from CMS, the IRE, or the Part D
plan sponsor participation in the proceedings. We are not proposing to
limit the number of participants in a hearing similar to proposed Sec.
405.1010(d) because the ALJ has the discretion to deny a request to
participate under Sec. 423.1010 and may
[[Page 43814]]
therefore deny a request to participate if the ALJ determines that a
hearing would have sufficient participant involvement or does not need
participant involvement.
We are proposing at Sec. 423.2010(d) to consolidate current Sec.
423.2010(d) through (f), to address the roles and responsibilities of
CMS, the IRE, or the Part D plan sponsor as a participant.
Specifically, we are proposing at Sec. 423.2010(d)(1) to generally
incorporate current Sec. 423.2010(d), which provides that
participation may include filing position papers or providing testimony
to clarify factual or policy issues, but it does not include calling
witnesses or cross-examining a party's witnesses. However, we are
proposing in Sec. 423.2010(d)(1) that participation may include filing
position papers ``and/or'' providing testimony to emphasize that either
or both may be done, and to remove the limitation that testimony must
be written because participation may include providing oral testimony
during the hearing. We are proposing at Sec. 423.2010(d)(2) to
incorporate current Sec. 423.2010(e), which provides that when
participating in a hearing, CMS, the IRE, or the Part D plan sponsor
may not be called as a witness during the hearing and, thus, are not
subject to examination or cross-examination by the enrollee at the
hearing. However, to be clear about how an enrollee and the ALJ may
address statements made by CMS, the IRE, or the Part D plan sponsor
during the hearing given that limitation, we also are proposing in
Sec. 423.2010(d)(2) that the enrollee may rebut factual or policy
statements made by the participant, and the ALJ may question the
participant about its testimony.
We are proposing at Sec. 423.2010(d)(3) to incorporate current
Sec. 423.2010(f) with certain revisions as discussed below. Current
Sec. 423.2010(f) states that CMS, the IRE, and/or the Part D plan
sponsor must submit any position papers within the time frame
designated by the ALJ. We are proposing in Sec. 423.2010(d)(3) to
include written testimony in the provision, establish deadlines for
submission of position papers and written testimony that reflect the
changes in participation elections in proposed 423.2010(b), and require
that copies of position papers and written testimony be sent to the
enrollee. Specifically, we are proposing in Sec. 423.2010(d)(3) that,
unless the ALJ or attorney adjudicator grants additional time to submit
a position paper or written testimony, a CMS, the IRE, or the Part D
plan sponsor position paper or written testimony must be submitted
within 14 calendar days for a standard appeal or 1 calendar day for an
expedited appeal after receipt of the ALJ's or attorney adjudicator's
decision on a request to participate if no hearing has been scheduled,
or no later than 5 calendar days prior to a non-expedited hearing or 1
calendar day prior to an expedited hearing. We are proposing to add
``written testimony'' to recognize that CMS, the IRE, or the Part D
plan sponsor or a contractor may submit written testimony as a
participant, in addition to providing oral testimony at a hearing. We
are proposing to require that position papers and written testimony be
submitted within 14 calendar days for a standard appeal or 1 calendar
day for an expedited appeal after receipt of the ALJ's or attorney
adjudicator's decision on a request to participate if no hearing has
been scheduled to help ensure the position paper and/or written
testimony are available when determinations are made to schedule a
hearing or issue a decision based on the record in accordance with
Sec. 405.1038. We also are proposing to require that if a hearing is
scheduled, position papers and written testimony be submitted no later
than 5 calendar days prior to a non-expedited hearing or 1 calendar day
prior to an expedited hearing (unless the ALJ grants additional time)
to help ensure the ALJ and the enrollee have an opportunity to review
the materials prior to the hearing. Similar to proposed Sec.
405.1010(c)(3)(iii), we also are proposing at Sec. 423.2010(d)(3)(ii)
that a copy of the position paper or written testimony must be sent to
the enrollee, and at Sec. 423.2010(d)(iii) that a position paper or
written testimony would not be considered in deciding an appeal if CMS,
the IRE, and/or the Part D plan sponsor fails to send a copy of the
position paper or written testimony to the enrollee or fails to submit
the position paper or written testimony within the established time
frames. This would help ensure CMS, IRE, or Part D plan sponsor
position papers and written testimony are submitted timely and shared
with the enrollee.
Currently, there are no provisions in Sec. 423.2010 to address the
possibility of CMS, the IRE, and/or the Part D plan sponsor making an
invalid request to participate. We are proposing to revise Sec.
423.2010(e) to add new provisions to establish criteria for when a
request to participate may be deemed invalid and provide standards for
notifying the entity and the enrollee when a request to participate is
deemed invalid. Proposed Sec. 423.2010(e)(1) would provide that an ALJ
or attorney adjudicator may determine a request to participate is
invalid if the request to participate was not timely filed or the
request to participate was not sent to the enrollee. This would help
ensure that CMS, the IRE, and/or the Part D plan sponsor make timely
requests to participate and inform the enrollee of requests. To provide
notice to the entity and the enrollee that a request to participate was
deemed invalid, proposed Sec. 423.2010(e)(2) would require a written
notice of an invalid request be sent to the entity that made the
request and the enrollee. If no hearing is scheduled for the appeal or
the request was made after the hearing occurred, proposed Sec.
423.2010(e)(2)(i) would provide that the notice of an invalid request
be sent no later than the date the decision, dismissal, or remand order
is mailed. If a non-expedited hearing is scheduled for the appeal,
proposed Sec. 423.2010(e)(2)(ii) would provide that written notice of
an invalid request is sent prior to the hearing, and that if the notice
would be sent fewer than 5 calendar days before the hearing, oral
notice must be provided to the entity, and the written notice must be
sent as soon as possible after the oral notice is provided. If an
expedited hearing is scheduled for the appeal, proposed Sec.
423.2010(e)(2)(iii) would provide that oral notice of an invalid
request must be provided to the entity, and the written notice must be
sent as soon as possible after the oral notice is provided. We are
proposing to require the oral notice for expedited hearings because the
very short time frames involved in expedited hearing proceedings often
do not allow for delivery of a written notice and the oral notice will
help ensure the entity is made aware of the invalid request prior to
the hearing.
We are inviting public comments on these proposals. If you choose
to comment on the proposals in this section, please include the caption
``Section 423.2010: When CMS, the IRE, or Part D plan sponsors may
participate in the proceedings on a request for an ALJ hearing'' at the
beginning of your comment.
iii. Section 405.1012: When CMS or Its Contractors May Be a Party to a
Hearing
Current Sec. 405.1012(a) states that CMS and/or its contractors
may be a party to an ALJ hearing unless the request for hearing is
filed by an unrepresented beneficiary. Current Sec. 405.1012(b) states
that CMS and/or the contractor(s) advises the ALJ, appellant, and all
other parties identified in the notice of hearing that it intends to
participate as a party no later than 10 calendar days after receiving
the notice of hearing. Current Sec. 405.1012(c) states that, when CMS
or its contractors participate in a
[[Page 43815]]
hearing as a party, it may file position papers, provide testimony to
clarify factual or policy issues, call witnesses or cross-examine the
witnesses of other parties. CMS or its contractor(s) will submit any
position papers within the time frame specified by the ALJ. CMS or its
contractor(s), when acting as parties, may also submit additional
evidence to the ALJ within the time frame designated by the ALJ.
Finally, current Sec. 405.1012(d) states that the ALJ may not require
CMS or a contractor to enter a case as a party or draw any adverse
inferences if CMS or a contractor decides not to enter as a party. As
stated previously, we are proposing significant changes to Sec.
405.1012.
Current Sec. 405.1012 does not limit the number entities that may
elect to be a party to the hearing. This has resulted in hearings for
some appeals being difficult to schedule and taking longer to conduct
due to multiple elections. To address these issues, we are proposing at
Sec. 405.1012(a)(1), except as provided in proposed paragraph (d)
discussed below, to only allow either CMS or one of its contractors to
elect to be a party to the hearing (unless the request for hearing is
filed by an unrepresented beneficiary, which precludes CMS and its
contractors from electing to be a party to the hearing). Current Sec.
405.1012(b) states that CMS or a contractor advises the ALJ, appellant,
and all other parties identified in the notice of hearing that it
intends to participate as a party no later than 10 calendar days after
receiving the notice of hearing. We are proposing at Sec. 405.1012(a)
to incorporate and revise a portion of current Sec. 405.1012(b), to
require that an election to be a party must be filed no later than 10
calendar days after the QIC receives the notice of hearing, because
notices of hearing are sent to the QIC in accordance with Sec.
405.1020(c) (the remaining portion of current Sec. 405.1012(b) is
incorporated with revisions into proposed Sec. 405.1012(b), as
discussed below).
Current Sec. 405.1012 does not have a provision similar to current
Sec. 405.1010(a), which states that an ALJ may request that CMS and/or
one or more of its contractors participate in the proceedings, but
current Sec. 405.1012(d) does provide that the ALJ may not require CMS
or a contractor to enter a case as a party or draw any adverse
inference if CMS or a contractor decided not to enter as a party. In
practice, ALJs do at times request that CMS or a contractor elect to be
a party to the hearing, in conjunction with a request for participation
under current Sec. 405.1010(a). To align the provisions and reflect
ALJ practices, we are proposing at Sec. 405.1012(a)(2) to state that
an ALJ may request but not require CMS and/or one or more of its
contractors to be a party to the hearing. We also are proposing in
Sec. 405.1012(a)(2) to incorporate current Sec. 405.1012(d) to
provide that that an ALJ cannot draw any adverse inferences if CMS or a
contractor decides not to enter as a party.
We are proposing at Sec. 405.1012(b) to address how CMS or a
contractor elects to be a party to the hearing. We are proposing to
follow the same process in current Sec. 405.1012(b) so that under
proposed Sec. 405.1012(b), CMS or the contractor would be required to
send written notice of its intent to be a party to the hearing to the
ALJ and the parties identified in the notice of hearing, which includes
the appellant.
We are proposing to set forth the roles and responsibilities of CMS
or a contractor as a party in Sec. 405.1012(c). Proposed Sec.
405.1012(c)(1) would incorporate current Sec. 405.1012(c) with some
changes in wording, both of which provide that as a party to the
hearing, CMS or a contractor may file position papers, submit evidence,
provide testimony to clarify factual or policy issues, call witnesses,
or cross-examine the witnesses of other parties. We are proposing in
Sec. 405.1012(c)(2) to include written testimony, such as an affidavit
or deposition, in the provision; establish deadlines for submission of
position papers, written testimony, and evidence; and require that
copies of position papers, written testimony, and evidence be sent to
the parties that were sent a copy of the notice of hearing.
Specifically, we are proposing in Sec. 405.1012(c)(2)(i) and
(c)(2)(ii) that any position papers, written testimony, and evidence
must be submitted no later than 5 calendar days prior to the hearing,
unless the ALJ grants additional time to submit the materials, and
copies must be sent to the parties who were sent a copy of the notice
of hearing. We are proposing to add ``written testimony'' to recognize
that CMS or a contractor may submit written testimony, in addition to
providing oral testimony at a hearing. We also are proposing to require
that position papers, written testimony, and/or evidence be submitted
no later than 5 calendar days prior to the hearing (unless the ALJ
grants additional time), and that copies be submitted to the parties
sent notice of the hearing, to help ensure the ALJ and the parties have
an opportunity to review the materials prior to the hearing. Current
Sec. 405.1012 does not address the consequence of failure to submit a
position paper or evidence in accordance with the section. We are
proposing in Sec. 405.1012(c)(2)(iii) that a position paper, written
testimony, and/or evidence would not be considered in deciding an
appeal if CMS or a contractor fails to send a copy of its position
paper, written testimony, and/or evidence to the parties or fails to
submit the position paper, written testimony, and/or evidence within
the established time frames. This would help ensure CMS or contractor
position papers and evidence are submitted timely and shared with the
parties.
As discussed above, current Sec. 405.1012 does not limit the
number entities (that is, CMS and its contractors) that may elect to be
a party to the hearing and, as also discussed above, we are proposing
to revise Sec. 405.1010 and 405.1012 to limit the number of entities
that participate in a hearing unless an ALJ determines that an entity's
participation is necessary for a full examination of the matters at
issue. We are proposing to revise Sec. 405.1012(d)(1) to provide that
if CMS and one or more contractors, or multiple contractors file
elections to be a party to a hearing, the first entity to file its
election after the notice of hearing is issued is made a party to the
hearing and the other entities are made participants in the proceedings
under Sec. 405.1010, subject to Sec. 405.1010(d)(1) and (3) (and as
such may file position papers and provide written testimony to clarify
factual or policy issues in the case, but may not participate in the
oral hearing unless the ALJ grants leave to the entity to participate
in the oral hearing in accordance with Sec. 405.1010(d)(3)). Similar
to proposed Sec. 405.1010(d)(3), we are also proposing in Sec.
405.1012(d)(2) that, notwithstanding the limitation in proposed Sec.
405.1012(d)(1), an ALJ may grant leave for additional entities to be
parties to the hearing if the ALJ determines that an entity's
participation as a party is necessary for full examination of the
matters at issue.
We believe allowing the first entity to file an election after a
notice of hearing is issued to be a party to the hearing is
administratively efficient and provides an objective way to determine
which entity is made a party based on the competing elections, while
providing an opportunity to participate in the appeal by filing a
position paper and/or written testimony under Sec. 405.1010 for those
that file later in time, or to be made a participant or party to the
hearing by the ALJ under the ALJ's discretionary authority under
proposed Sec. Sec. 405.1010(d)(3) and 405.1012(d)(2). We considered an
alternate proposal of the first entity that had elected
[[Page 43816]]
participant status under Sec. 405.1010, if any, being given priority
for being made a party to the hearing, but believe that would result in
other entities making a party election being uncertain whether they
will be made a party to the hearing until as few as 5 days prior to the
hearing (assuming the notice of hearing is sent 20 days prior to the
scheduled hearing, as required by Sec. 405.1022(a), the QIC receives
the notice of hearing 5 days later, and the entity or entities
responding to the notice of hearing can make their election as late as
10 calendar days after the QIC's receipt of the notice, leaving only 5
days prior to the hearing). We also considered a process by which the
ALJ would assess which entity making a party election would be most
helpful to the ALJ at the hearing, or in the alternative, permitting
all entities that filed a party election to be made a party to the
hearing unless the ALJ determined an entity is not necessary for the
hearing, but both of these approaches would add administrative burden
to the ALJ and could result in CMS, contractors and parties being
uncertain of which entities will be parties to the hearing until
shortly before the hearing. We welcome comments on the alternatives
considered above.
Finally, we are proposing to add new Sec. 405.1012(e) to address
the possibility of CMS or a contractor making an invalid election.
Proposed Sec. 405.1012(e)(1) would provide that an ALJ or attorney
adjudicator may determine an election is invalid if the request for
hearing was filed by an unrepresented beneficiary, the election was not
timely, the election was not sent to the correct parties, or CMS or a
contractor had already filed an election to be a party to the hearing
and the ALJ did not determine that the entity's participation as a
party is necessary for a full examination of the matters at issue. This
would help ensure that CMS and its contractors make timely elections
and inform parties of elections, and also provide a mechanism to
address an election when the request for hearing was filed by an
unrepresented beneficiary or when another entity has already filed an
election to be a party to the hearing. To provide notice to the entity
and the parties that an election was deemed invalid, proposed Sec.
405.1012(e)(2) would require a written notice of an invalid election be
sent to the entity that made the election and the parties who were sent
the notice of hearing. If the election was submitted after the hearing
occurred, proposed Sec. 405.1012(e)(2)(i) would provide that the
notice of an invalid election be sent no later than the date the
decision, dismissal, or remand notice is mailed. If the election was
submitted before the hearing occurs, proposed Sec. 405.1012(e)(2)(ii)
would provide that the written notice of invalid election is sent prior
to the hearing, and that if the notice would be sent fewer than 5
calendar days before the hearing is scheduled to occur, oral notice
would be provided to the entity that submitted the election, and the
written notice to the entity and the parties who were sent the notice
of hearing would be sent as soon as possible after the oral notice is
provided.
We are inviting public comments on these proposals. If you choose
to comment on the proposals in this section, please include the caption
``Section 405.1012: When CMS or its contractors may be a party to a
hearing'' at the beginning of your comment.
g. Request for an ALJ Hearing or Review of a QIC or IRE Dismissal
(Sec. Sec. 405.1014, 423.1972 and 423.2014)
Current Sec. Sec. 405.1014 and 423.2014 explain the requirements
for requesting an ALJ hearing, including what must be contained in the
request, when and where to file the request, the extension of time to
request a hearing, and in Sec. 405.1014 to whom a copy of the request
for hearing must be sent. We are proposing to restructure the sections,
clarify and provide additional instructions, and address other matters
that have caused confusion for parties and adjudicators.
i. Requirements for a Request for Hearing or Review of a QIC or IRE
Dismissal
We are proposing to revise the title and provisions of Sec. Sec.
405.1014 and 423.2014 to more clearly cover a request for a review of a
QIC or IRE dismissal. While the current requirements for requesting an
ALJ hearing are generally used for requesting a review of a QIC or IRE
dismissal in form HHS-725, we believe that explicitly extending
Sec. Sec. 405.1014 and 423.2014 to cover requests for these types of
review would provide clarity to parties and adjudicators on the
requirements for requesting a review of a QIC or IRE dismissal. As
such, we are proposing in the title to Sec. 405.1014 and in subsection
(a)(1) (current subsection (a)) to add ``or a review of a QIC
dismissal'' after ``ALJ hearing,'' and in subsection (c) (current
subsection (b)) to delete ``after a QIC reconsideration'' and add ``or
request for review of a QIC dismissal'' after ``an ALJ hearing.''
Similarly, we are proposing in the title to Sec. 423.2014 and in
subsection (a)(1) (current subsection (a)) to add ``or a review of an
IRE dismissal'' after ``ALJ hearing,'' and in subsection (d) (current
subsection (c)) to add ``or request for review of an IRE dismissal''
after ``IRE reconsideration.''
We are proposing in Sec. 405.1014(a)(1)(i) through (a)(1)(vi) to
incorporate current Sec. 405.1014(a)(1) through (a)(6) with revisions.
In addition to the current requirements in subsection (a)(1), we are
proposing in Sec. 405.1014(a)(1)(i) to require the beneficiary's
telephone number if the beneficiary is the filing party and is not
represented. This would help ensure that OMHA is able to make timely
contact with the beneficiary to clarify his or her filing, or other
matters related to the adjudication of his or her appeal, including
scheduling the hearing. We are proposing in Sec. 405.1014(a)(1)(ii) to
require the appellant's telephone number, along with the appellant's
name and address as currently required in subsection (a)(2), when the
appellant is not the beneficiary, and in Sec. 405.1014(a)(1)(iii) to
require a representative's telephone number, along with the
representative's name and address which is currently included in
subsection (a)(3), if a representative is involved. Like the
beneficiary telephone number requirement, these requirements would help
ensure that OMHA is able to make timely contact with a non-beneficiary
appellant and any representative involved in the appeal to clarify the
filing or other matters related to the adjudication of the appeal,
including scheduling the hearing. Current subsection (a)(4) states that
the request must include the document control number assigned to the
appeal by the QIC, if any. We are proposing in Sec. 405.1014(a)(1)(iv)
to require the Medicare appeal number or document control number, if
any, assigned to the QIC reconsideration or dismissal notice being
appealed, to reduce confusion for appellants. We are proposing in Sec.
405.1014(a)(1)(v) to add language to the current language in subsection
(a)(5), so that instead of requiring the ``dates of service,'' we would
require the ``dates of service for the claims being appealed, if
applicable,'' because an appellant may appeal some but not all of the
partially favorable or unfavorable claims in a QIC reconsideration and
a small number of appeals do not involve a date of service (for
example, entitlement appeals). We are proposing to incorporate the same
language in current subsection (a)(6) into proposed subsection
(a)(1)(vi).
We are proposing to add a new requirement to the content of the
request in Sec. 405.1014(a)(1)(vii) by
[[Page 43817]]
requiring a statement of whether the filing party is aware that it or
the claim is the subject of an investigation or proceeding by the OIG
or other law enforcement agencies. This information is necessary to
assist OMHA staff in checking whether the provider or supplier was
excluded from the program on the date of service at issue prior to
scheduling a hearing or issuing a decision, as well as for the ALJ to
determine whether to request the participation of CMS or any program
integrity contractors that may have been involved in reviewing the
claims below. However, we note that the information is only required if
the filing party is aware of an investigation and proceeding, and the
information would not be the basis for a credibility determination on
evidence or testimony, as an investigation or allegations prior to
findings of wrongdoing by a court of competent jurisdiction are not an
appropriate foundation for credibility determinations in the context of
part 405, subpart I administrative appeals.
As discussed in Section III.A.3.d above, we are proposing changes
to the methodology for calculating the amount in controversy required
for an ALJ hearing to better align the amount in controversy with the
actual amount in dispute. We are also proposing new Sec.
405.1014(a)(1)(viii) to require that providers, suppliers, Medicaid
State agencies, applicable plans, and beneficiaries represented by a
provider, supplier, or Medicaid State agency include in their request
for hearing the amount in controversy applicable to the disputed claim,
as specified in Sec. 405.1006(d), unless the matter involves a
provider or supplier termination of Medicare-covered items or services
that is disputed by a beneficiary, and the beneficiary did not elect to
continue receiving the items or services. As we discussed in section
III.A.3.d., in instances where the Medicare allowable amount would
serve as the basis for the amount in controversy (which we believe
would be the majority of Part B appeals), we believe providers,
suppliers, and Medicaid State agencies would be able to utilize
existing CMS tools and resources to determine the allowable amount used
as the basis for the amount in controversy under proposed Sec.
405.1006(d)(2)(i)(A) and arrive at the amount in controversy after
deducting any Medicare payments that have already been made or awarded
and any deductible and/or coinsurance that may be collected for the
items and services in the disputed claim. In addition, we believe that
providers, suppliers, applicable plans, and Medicaid State agencies
also would have access to the billing, payment and other necessary
information to calculate the amount in controversy under other
provisions of Sec. 405.1006(d). For scenarios where the basis for the
amount in controversy would be calculated in accordance with proposed
Sec. 405.1006(d)(2)(i)(B), (ii), (iii), or where the amount in
controversy would be calculated in accordance with Sec.
405.1006(d)(3), (5), (6), or (7), we discuss in section III.A.3.d above
how appellants would determine the amount in controversy in order to
include it on their request for hearing. However, because we believe
there may be instances where a beneficiary who is not represented by a
provider, supplier, or Medicaid State agency may not have the
information necessary to determine the amount in controversy under
Sec. 405.1006(d) (as discussed above), we are not proposing to require
beneficiaries who are not represented by a provider, supplier, or
Medicaid State agency to include the amount in controversy in their
requests for hearing. Furthermore, as noted above, we are not proposing
that any appellant include the amount in controversy on requests for
hearing where the amount in controversy would be calculated in
accordance with Sec. 405.1006(d)(4) (for a provider or supplier
termination of Medicare-covered items or services that is disputed by a
beneficiary, and the beneficiary did not elect to continue receiving
the items or services). We expect that, in this situation, a
beneficiary could easily determine whether the minimum amount in
controversy required for an ALJ hearing would be met through a
conversation with the provider or supplier, or from the statement we
are proposing the QIC include in its notice of reconsideration as
discussed in section III.A.3.d above. However, we believe the exact
amount in controversy could be difficult to determine because it may
depend on unknown factors, such as the length of continued services
that may be required, and so we are not requiring appellants to include
this amount in the request for hearing.
Lastly, current Sec. 405.1014(a)(7), which requires a statement of
any additional evidence to be submitted and the date it will be
submitted, would be separately designated in its entirety as proposed
Sec. 405.1014(a)(2) because the information in proposed Sec.
405.1014(a)(1) must be present for a request for hearing to be
processed and therefore would make the request subject to dismissal if
the information is not provided, as discussed below. In contrast, the
information in proposed Sec. 405.1014(a)(2) is only necessary if
evidence would be submitted and would not make the request subject to
dismissal if not present in the request.
Similar to proposed Sec. 405.1014(a), we are proposing at Sec.
423.2014(a)(1)(i) through (a)(1)(vi) to incorporate current Sec.
423.2014(a)(1) through (a)(6) with revisions. Current subsection (a)(3)
states that the request must include the appeals case number assigned
to the appeal by the IRE, if any. We are proposing in Sec.
405.1014(a)(1)(iii) to revise the requirement to state that the request
must include the Medicare appeal number, if any, assigned to the IRE
reconsideration or dismissal being appealed, to reflect the terminology
used by the IRE and thereby reduce confusion for enrollees. Current
subsection (a)(6) states that the request must include the reasons the
enrollee disagrees with the IRE's reconsideration. We are proposing to
insert ``or dismissal'' after ``reconsideration'' to again reflect the
terminology used by the IRE and thereby reduce confusion for enrollees.
For the same reasons as we proposed for Sec. 405.1014(a)(1)(vii), we
are proposing at Sec. 423.2014(a)(1)(vii) to require a statement of
whether the enrollee is aware that he or she, or the prescription for
the drug being appealed, is the subject of an investigation or
proceeding by the OIG or other law enforcement agencies. In addition,
we are proposing at Sec. 423.2014(a)(2) to incorporate the current
Sec. 423.2014(a)(7) requirement to include a statement of any
additional evidence to be submitted and the date it will be submitted,
and at Sec. 423.2014(a)(3) to incorporate the current Sec.
423.2014(a)(8) requirement to include a statement that the enrollee is
requesting an expedited hearing, if applicable.
We are inviting public comments on these proposals. If you choose
to comment on the proposals in this section, please include the caption
``Requirements for a request for hearing or review of a QIC or IRE
dismissal'' at the beginning of your comment.
ii. Requests for Hearing Involving Statistical Sampling and
Extrapolations
We are proposing to add new Sec. 405.1014(a)(3) to address appeals
in which an appellant raises issues regarding a statistical sampling
methodology and/or an extrapolation that was used in making an
overpayment determination. OMHA has encountered significant issues when
an appellant challenges aspects of a statistical sampling methodology
and/or the results of extrapolations in separate
[[Page 43818]]
appeals for each sampled claim involved in the statistical sampling
and/or extrapolation. Appeals often need to be reassigned to avoid
multiple adjudicators addressing the challenges to the statistical
sampling methodology and/or extrapolation, and any applicable
adjudication time frames attach to the individual appeals. Under
proposed Sec. 405.1014(a)(3), if an appellant is challenging the
statistical sampling methodology and/or extrapolation, the appellant's
request for hearing must include the information in proposed Sec.
405.1014(a)(1) and (a)(2) for each sample claim that the appellant
wishes to appeal, be filed within 60 calendar days of the date that the
party received the last reconsideration for the sample claims (if they
were not all addressed in a single reconsideration), and assert the
reasons the appellant disagrees with the statistical sampling
methodology and/or extrapolation in the request for hearing. We believe
it would be appropriate in this situation to allow the appellant's
request for hearing to be filed within 60 calendar days of the date
that the party received the last reconsideration for the sample claims
(if they were not all addressed in a single reconsideration), because
if the appellant also wishes to challenge the statistical sampling
methodology and/or extrapolation, the appellant would wait to file a
request for hearing until all of the QIC reconsiderations for the
sample units are received, which could be more than 60 calendar days
after the first received QIC reconsideration of one of the sample
claims. We also state that the 60 calendar day period in proposed Sec.
405.1014(a)(3)(ii) would begin on the date the party receives the last
reconsideration of a sample claim, regardless of the outcome of the
claim in the reconsideration or whether the sample claim is appealed in
the request for hearing. We believe proposed Sec. 405.1014(a)(3) would
balance the party's rights to request a hearing on individual claims
when only the sample claims are appealed, with the needs to
holistically address issues related to statistical sampling
methodologies and extrapolations when those determinations are also
challenged. We are not proposing any corresponding changes to Sec.
423.2014 because sampling and extrapolation are not currently used in
Part D appeals.
We are inviting public comments on these proposals. If you choose
to comment on the proposals in this section, please include the caption
``Requests for hearing involving statistical sampling and
extrapolations'' at the beginning of your comment.
iii. Opportunity To Cure Defective Filings
There has been considerable confusion on the implications of not
providing the information required by current Sec. 405.1014(a) in
order to perfect a request for hearing, and significant time and
resources have been spent on this procedural matter by parties, OMHA,
and the Council. To provide clearer standards and reduce confusion, we
are proposing in Sec. 405.1014(b)(1) that a request for hearing or
request for a review of a QIC dismissal must contain the information
specified in proposed Sec. 405.1014(a)(1) to the extent the
information is applicable, to be complete, and Sec. 405.1014(b)(1)
would provide that any applicable adjudication time frame does not
begin until the request is complete because the information is
necessary to the adjudication of the appeal. We are proposing in Sec.
405.1014(b)(1) to also provide an appellant with an opportunity to
complete the request if the request is not complete. However, if the
appellant fails to provide the information necessary to complete the
request in the time frame provided, the request would not be complete
and would be dismissed in accordance with proposed Sec. 405.1052(a)(7)
or (b)(4). We are also proposing at Sec. 405.1014(b)(2) to allow for
consideration of supporting materials submitted with a request when
determining whether the request is complete, provided the necessary
information is clearly identifiable in the materials, to provide that
an appellant's request and supporting materials is considered in its
totality. For example, if an appellant were to submit a request for
hearing and included a copy of the QIC reconsideration, the Medicare
appeal number on the QIC reconsideration would generally satisfy the
subsection (a)(1)(iv) requirement because it clearly provides the
information. However, if there are multiple claims in the QIC
reconsideration, the same document possibly would not satisfy
subsection (a)(1)(v) because the appellant is not required to appeal
all partially favorable or unfavorable claims, and subsection (a)(1)(v)
requires the appellant to indicate the dates of service for the claims
that are being appealed. Similarly, including medical records only for
the dates of service that the appellant wishes to appeal would
generally not satisfy subsection (a)(1)(v) because it would be unclear
whether the appellant intended to limit the appeal to only those dates
of service for which medical records were included, or those were the
only dates of service for which the appellant had medical records. We
are proposing that the provisions of proposed Sec. 405.1014(b) be
adopted in proposed Sec. 423.2014(c) for requesting an ALJ hearing or
a review of an IRE dismissal in Part D appeals.
We are inviting public comments on these proposals. If you choose
to comment on the proposals in this section, please include the caption
``Opportunity to cure defective filings'' at the beginning of your
comment.
iv. Where and When To File a Request for Hearing or Review of a QIC or
IRE Dismissal
We are proposing to incorporate portions of current Sec.
405.1014(b) in proposed Sec. 405.1014(c) and portions of current Sec.
423.2014(c) in proposed Sec. 423.2014(d) to address when and where to
file a request for hearing or review. We are proposing in Sec. Sec.
405.1014(c) introductory language and (c)(1), and 423.2014(d)
introductory language and (d)(1), to incorporate a request for a review
of a QIC dismissal and a request for a review of an IRE dismissal,
respectively, and provide that the current 60 calendar day period to
file a request for hearing after a party receives a QIC or an IRE
reconsideration also applies after a party receives a QIC or IRE
dismissal, which is the time frame stated in Sec. Sec. 405.1004 and
423.2004 to request a review of a QIC or IRE dismissal, respectively.
We also are proposing in Sec. 405.1014(c)(1) to add an exception for
requests filed in accordance with proposed Sec. 405.1014(a)(3)(ii),
because as discussed above, we are proposing to require that requests
for hearing on sample claims that are part of a statistical sample and/
or extrapolation that the appellant also wishes to challenge would be
filed together, which may be more than 60 calendar days after the
appellant receives the first QIC reconsideration of one of the sample
claims. In addition, we are proposing to revise the statement that a
request must be ``submitted'' in current Sec. 423.2014(c)(1), with a
request must be ``filed'' in Sec. 423.2014(d)(1), for consistency with
Sec. 405.1014 and Sec. 422.602, both of which use the term ``filed.''
We are also proposing in Sec. Sec. 405.1014(c)(2) and 423.2014(d)(2)
to replace references to sending requests to the ``entity'' specified
in the QIC's or IRE's reconsideration in current Sec. Sec.
405.1014(b)(2) and 423.2014(c)(2), with sending requests to the
``office'' specified in the QIC's or IRE's reconsideration or
dismissal, respectively, so they are properly routed. As discussed in
III.A.3.b. and III.A.3.c, above, regarding proposed
[[Page 43819]]
Sec. Sec. 405.1002 and 405.1004, and 423.2002 and 423.2004, replacing
``entity'' with ``office'' in Sec. Sec. 405.1014, 423.1972, and
423.2014 would help ensure appellants are aware that a request for
hearing or request for a review of a QIC or IRE dismissal must be filed
with the office indicated in the QIC's or IRE's reconsideration or
dismissal and avoid delays. However, we again note that for the few
requests for hearing that are misrouted by a party, a notice would be
sent to the appellant when the request for hearing is received in the
correct office and the date the timely request was received by the
incorrect office would be used to determine the timeliness of the
request, in accordance with proposed Sec. Sec. 405.1014(c)(2) and
423.2014(d)(2)(i), which would incorporate the misrouted request
provisions from current Sec. Sec. 405.1014(b)(2) and
423.2014(c)(2)(i). We are also proposing in Sec. Sec. 405.1014(c)(2)
and 423.2014(d)(2)(i) that the adjudication time frame is only affected
if there is an applicable adjudication time frame for the appeal.
Current Sec. 423.1972(b) states that an enrollee must file a
request for a hearing within 60 calendar days of the date of the notice
of the IRE reconsideration determination. This requirement differs from
Sec. 423.2002(a)(1), which states that a request for hearing must be
filed within 60 calendar days after receipt of the IRE's
reconsideration (this is also the standard for filing Part A and Part B
requests for hearing after receipt of QIC reconsiderations, at Sec.
405.1002(a)(1). We are proposing to revise Sec. 423.1972(b)(1) to
state that a request for hearing must be filed within 60 calendar days
after receipt of the IRE's reconsideration. We also are proposing to
add new Sec. 423.1972(b)(2), to incorporate current Sec. 423.2002(d),
which provides the date of receipt of the reconsideration is presumed
to be 5 calendar days after the date of the written reconsideration
unless there is evidence to the contrary (this is also a presumption
for receipt of QIC reconsiderations in Part A and Part B appeals, at
Sec. 405.1002). These changes would align proposed Sec. 423.1972(b)
with current Sec. 423.2002, and remove potential enrollee confusion on
when a request for an ALJ hearing must be filed.
We are inviting public comments on these proposals. If you choose
to comment on the proposals in this section, please include the caption
``Where and when to file a request for hearing or review of a QIC or
IRE dismissal'' at the beginning of your comment.
v. Sending Copies of a Request for Hearing and Other Evidence to Other
Parties to the Appeal
We are proposing to incorporate the portion of current Sec.
405.1014(b)(2) that states that the appellant must also send a copy of
the request for hearing to the other parties and failure to do so will
toll the ALJ's 90 calendar day adjudication deadline until all parties
to the QIC reconsideration receive notice of the requested ALJ hearing
in proposed Sec. 405.1014(d) with changes discussed below. Current
Sec. 405.1014(b)(2) has been another source of considerable confusion,
and significant time and resources have been spent on this procedural
matter by parties, OMHA, and the Council. Current Sec. 405.1014(b)(2)
requires an appellant to send a copy of the request for hearing to the
other parties. Other parties consist of all of the parties specified in
Sec. 405.906(b) as parties to the reconsideration, including
beneficiaries in overpayment cases that involve multiple beneficiaries
who have no liability, in which case the QIC may elect to only send a
notice of reconsideration to the appellant, in accordance with Sec.
405.976(a)(2). We are proposing in Sec. 405.1014(d)(1) to amend the
current copy requirement by only requiring an appellant to send a copy
of a request for an ALJ hearing or review of a QIC dismissal to the
other parties who were sent a copy of the QIC's reconsideration or
dismissal. This change would make the standard consistent with requests
for Council review, a copy of which must be sent by the appellant to
the other parties who received a copy of an ALJ's decision or
dismissal, in accordance with current Sec. 405.1106(a). This change
would also extend the requirement to requests for review of a QIC
dismissal to provide the other parties who received notice of the QIC's
dismissal action with notice of the appellant's appeal of that action.
We are also proposing in Sec. 405.1014(d)(1) to address whether
copies of materials that an appellant submits with a request for
hearing or request for review of a QIC dismissal must be sent to other
parties. Currently some ALJs consider the materials to be part of the
request and require an appellant to send copies of all materials
submitted with a request, while other ALJs do not consider the
materials to be part of the request. We are proposing in Sec.
405.1014(d)(1) that if additional materials submitted with a request
are necessary to provide the information required for a complete
request in accordance with proposed Sec. 405.1014(b), copies of the
materials must be sent to the parties as well (subject to authorities
that apply to disclosing the personal information of other parties). If
additional evidence is submitted with the request for hearing, the
appellant may send a copy of the evidence or briefly describe the
evidence pertinent to the party and offer to provide copies of the
evidence to the party at the party's request (subject to authorities
that apply to disclosing the evidence). For example, if a complete
request includes a position paper or brief that explains the reasons
the appellant disagrees with the QIC's reconsideration, in accordance
with proposed Sec. 405.1014(a)(1)(v), a copy of the position paper or
brief would be sent to the other parties, subject to any authorities
that apply to disclosing the personal information of other parties.
However, additional evidence such as medical records, is generally not
required for a complete request, and therefore copies would not have to
be sent, but could instead be summarized and provided to the other
parties at their request, again subject to any authorities that apply
to disclosing the personal information of other parties. This approach
would balance the objectives of ensuring that parties to a claim and an
appeal of that claim remain informed of the proceedings that are
occurring on the claim, with the burdens on appellants to keep their
co-parties so informed. We also note that in sending a copy of the
request for hearing and associated materials, appellants are free to
include cover letters to explain the request, but we note that such
letters on their own do not satisfy the copy requirement in its current
or proposed form. No corresponding changes are proposed in Sec.
423.2014 because the enrollee is the only party to the appeal.
Current Sec. 405.1014 does not contain standards for what
constitutes evidence that a copy of the request for hearing or review,
or copy of the evidence or a summary thereof, was sent to the other
parties, which has led to confusion and inconsistent practices.
Therefore, we are proposing in Sec. 405.1014(d)(2) to address this
issue by establishing standards that an appellant would follow to
satisfy the requirement. We are proposing in Sec. 405.1014(d)(2) that
evidence that a copy of the request for hearing or review, or a copy of
submitted evidence or a summary thereof, was sent includes: (1)
Certifications that a copy of the request for hearing or request for
review of a QIC dismissal is being sent to the other parties on the
standard form for requesting a hearing or review of a QIC dismissal;
(2) an indication, such as a copy or ``cc'' line on a request for
[[Page 43820]]
hearing or review, that a copy of the request and any applicable
attachments or enclosures are being sent to the other parties,
including the name and address of the recipients; (3) an affidavit or
certificate of service that identifies the name and address of the
recipient and what was sent to the recipient; or (4) a mailing or
shipping receipt that identifies the name and address of the recipient
and what was sent to the recipient. We believe these options would
provide an appellant with flexibility to document the copy requirement
was satisfied and bring consistency to the process.
Beyond stating that an adjudication time frame is tolled if a party
does not satisfy the copy requirement, current Sec. 405.1014 does not
address the consequence of not satisfying the requirement, and
adjudicators are faced with an appeal being indefinitely tolled because
an appellant refuses to comply with the requirement. OMHA ALJs have
addressed this issue by providing appellants with an opportunity to
send the required copy of the request for hearing, and by informing the
appellant that if the copy is not sent, its request will be dismissed.
This allows OMHA ALJs to remove requests that do not satisfy the
requirement from their active dockets so time and resources can be
focused on appeals of those who comply with the rules. We are proposing
in Sec. 405.1014(d)(3) that, if the appellant fails to send a copy of
the request for hearing or request for review of a QIC dismissal, any
additional materials, or a copy of the submitted evidence or a summary
thereof, the appellant would be provided with an opportunity to cure
the defects by sending the request, materials, and/or evidence or
summary thereof described in proposed subsection (d)(1). Further,
proposed Sec. 405.1014(d)(3) would provide that if an adjudication
time frame applies, it does not begin until evidence that the request,
materials, and/or evidence or summary thereof were sent is received. We
are also proposing in Sec. 405.1014(d)(3) that if an appellant does
not provide evidence within the time frame provided to demonstrate that
the request, materials, and/or evidence or summary thereof were sent to
other parties, the appellant's request for hearing or review would be
dismissed.
We are inviting public comments on these proposals. If you choose
to comment on the proposals in this section, please include the caption
``Sending copies of a request for hearing and other evidence to other
parties to the appeal'' at the beginning of your comment.
vi. Extending Time To File a Request for Hearing or Review of a QIC or
IRE Dismissal
We are proposing that the provisions of current Sec. Sec.
405.1014(c) and 423.2014(d) for extensions of time to file a request
for hearing would be incorporated in proposed Sec. Sec. 405.1014(e)
and 423.2014(e) with changes, and would extend to requests for reviews
of QIC and IRE dismissals. On occasion, OMHA is asked whether a request
for an extension should be filed without a request for hearing, for a
determination on the request for extension before the request for
hearing is filed. In those instances, we ask the filer to file both the
request for hearing and request for extension at the same time because
an independent adjudication of the extension request would be
inefficient and any adjudication time frame begins on the date that the
ALJ grants the extension request, in accordance with current Sec. Sec.
405.1014(c)(4) and 423.2014(d)(4). We are proposing in Sec. Sec.
405.1014(e)(2) and 423.2014(e)(3) to require a request for an extension
be filed with the request for hearing or request for review of a QIC or
IRE dismissal, with the office specified in the notice of
reconsideration or dismissal. Proposed Sec. Sec. 405.1014(e)(2) and
423.2014(e)(3) would also align the provision with proposed Sec. Sec.
405.1014(c) and 423.2014(d) by specifying that a request for an
extension must be filed with the ``office,'' rather than the
``entity,'' specified in the notice of reconsideration. We are
proposing in Sec. 405.1014(e)(3) and 423.2014(e)(4) that an ALJ or
attorney adjudicator may find good cause to extend the deadline to file
a request for an ALJ hearing or a request for a review of a QIC or IRE
dismissal, or there is no good cause for missing the deadline to file a
request for a review of a QIC or IRE dismissal, but only an ALJ may
find there is no good cause for missing the deadline to file a request
for an ALJ hearing. Because only an ALJ may dismiss a request for an
ALJ hearing for an untimely filing in accordance with proposed
Sec. Sec. 405.1052 and 423.2052, an attorney adjudicator could not
make a determination on a request for an extension that would result in
a dismissal of a request for hearing. We are also proposing to
incorporate current Sec. Sec. 405.1014(c)(4) and 423.2014(d)(5) into
proposed Sec. Sec. 405.1014(e)(4) and 423.2014(e)(5), but indicate
that the adjudication time frame begins on the date the ALJ or attorney
adjudicator grants the request to extend the filing deadline only if
there is an applicable adjudication period. Finally, we are proposing
in Sec. Sec. 405.1014(e)(5) and 423.2014(e)(6) to add a new provision
to provide finality for the appellant with regard to a determination to
grant an extension of the filing deadline. We are proposing that if an
ALJ or attorney adjudicator were to make a determination to grant the
extension, the determination is not subject to further review. However,
we are not precluding review of a determination to deny an extension
because such a denial would result in a dismissal for an untimely
filing, and the dismissal and determination on the request for an
extension would be subject to review by the Council.
We are inviting public comments on these proposals. If you choose
to comment on the proposals in this section, please include the caption
``Extending time to file a request for hearing or review of a QIC or
IRE dismissal'' at the beginning of your comment.
h. Time Frames for Deciding an Appeal of a QIC or IRE Reconsideration
or an Escalated Request for a QIC Reconsideration, and Request for
Council Review When an ALJ Does Not Issue a Decision Timely (Sec. Sec.
405.1016, 405.1104 and 423.2016)
i. Section 405.1016: Time frames for Deciding an Appeal of a QIC or an
Escalated Request for a QIC Reconsideration
Current Sec. 405.1016 addresses the adjudication time frames for
requests for hearing filed after a QIC has issued its reconsideration,
in accordance with section 1869(d)(1)(A) of the Act, and escalations of
requests for a QIC reconsideration when the QIC does not issue its
reconsideration within its adjudication time frame, which is permitted
by section 1869(c)(3)(C)(ii) of the Act. We are proposing to revise the
title of Sec. 405.1016 from ``Time frames for deciding an appeal
before an ALJ'' to ``Time frames for deciding an appeal of a QIC
reconsideration or escalated request for a QIC reconsideration''
because the section specifically applies to appeals of QIC
reconsiderations and escalated requests for QIC reconsiderations (as
specified in current and proposed Sec. 405.1016(a) and (c)). This
revision would also allow for application of this section to requests
for hearing adjudicated by attorney adjudicators, as proposed in
Section II.B. above. We also are proposing to replace each instance of
the term ``the ALJ'' with ``the ALJ or attorney adjudicator''
throughout proposed Sec. 405.1016 to assist appellants in
understanding that an adjudication time frame, and the option to
escalate, also
[[Page 43821]]
would apply to a request for an ALJ hearing following a QIC
reconsideration when the request has been assigned to an attorney
adjudicator, as proposed in section II.B, above. We are not proposing
to change the reference to ``a request for an ALJ hearing'' because, as
explained above in section II.B, even if an appellant waives its right
to hearing, the case would remain subject to a potential oral hearing
before an ALJ, and we believe the request is therefore properly
characterized as a request for an ALJ hearing.
We are proposing to add titles to proposed Sec. 405.1016(a) to
indicate that this paragraph discusses the adjudication period for
appeals of QIC reconsiderations, and proposed Sec. 405.1016(c) to
indicate that this paragraph discusses the adjudication period for
escalated requests for QIC reconsiderations. In addition, proposed
Sec. 405.1016(a) and (c) would remove ``must,'' in providing that when
a request for an ALJ hearing is filed after a QIC has issued a
reconsideration, an ALJ or attorney adjudicator issues a decision,
dismissal order, or remand to the QIC, as appropriate, no later than
the end of the 90 calendar day period beginning on the date the request
for hearing is received by the office specified in the QIC's notice of
reconsideration. While the statute envisions that appeals will be
adjudicated within the statutory time frame, the statute also provides
for instances in which the adjudication time frame is not met by
allowing an appellant to escalate his or her appeal to the next level
of appeal. We believe ``must'' should be reserved for absolute
requirements, and in the context of adjudication time frames, the
statute provides the option for an appellant to escalate an appeal if
the adjudication time frame is not met.
We are proposing to add a title to proposed Sec. 405.1016(b) to
indicate that the paragraph discusses when an adjudication period
begins. Current Sec. 405.1016(b), which explains that the adjudication
period for an appeal of a QIC reconsideration begins on the date that a
timely filed request for hearing is received unless otherwise specified
in the subpart, would be re-designated as proposed Sec.
405.1016(b)(1). We are proposing in Sec. 405.1016(b)(2) that if the
Council remands a case and the case was subject to an adjudication time
frame under paragraph (a) or (c), the remanded appeal would be subject
to the adjudication time frame of Sec. 405.1016(a) beginning on the
date that OMHA receives the Council remand. Currently the regulations
do not address whether an adjudication time frame applies to appeals
that are remanded from the Council, and whether escalation is an option
for these appeals. To provide appellants with an adjudication time
frame for remanded appeals that were subject to an adjudication time
frame when they were originally appealed to OMHA, proposed Sec.
405.1016(b)(2) would apply the adjudication time frame under Sec.
405.1016(a) to a remanded appeal that was subject to an adjudication
time frame under paragraph (a) or (c). For example, if an ALJ decision
reviewed by the Council involved a QIC reconsideration and was remanded
by the Council, a 90 calendar day time frame would apply from the date
that OMHA received the remand order. If the adjudication time frame is
not met under proposed Sec. 405.1016(b)(2), the appeal would be
subject to escalation, in accordance with proposed Sec. 405.1016(e).
In addition, we are proposing in Sec. 405.1016(a) and (b) to align
the paragraphs with proposed Sec. 405.1014(c) by specifying that a
request for hearing is received by the ``office,'' rather than the
``entity,'' specified in the QIC's notice of reconsideration.
We are proposing to add a title to proposed Sec. 405.1016(d) to
indicate that the paragraph discusses waivers and extensions of the
adjudication period. We are proposing in Sec. 405.1016(d)(1) to
incorporate the adjudication period waiver provision in current Sec.
405.1036(d), which states that, at any time during the hearing process,
the appellant may waive the adjudication deadline specified in Sec.
405.1016 for issuing a hearing decision, and that the waiver may be for
a specific period of time agreed upon by the ALJ and the appellant. We
are proposing to move the provision because we believe it is more
appropriately addressed in Sec. 405.1016, as it is directly related to
the adjudication period. Proposed Sec. 405.1016(d) would also revise
the language in current Sec. 405.1036(d) to reference an attorney
adjudicator consistent with our proposals in Section II.B. above; to
reference the ``adjudication'' process rather than the ``hearing
process'' to account for appeals that may not involve a hearing, to
consistently reference an adjudication ``period'' for internal
consistency, and to replace the reference to Sec. 405.1016 with
internal paragraph references.
Current Sec. 405.1016 does not address delays that result from
stays ordered by U.S. Courts. In addition, we have had instances in
which an appellant requests a stay of action on his or her appeals
while related matters are addressed by another court or tribunal, or by
investigators. To address these circumstances, we are proposing in
Sec. 405.1016(d)(2) that the adjudication periods specified in
paragraphs (a) and (c) are extended as otherwise specified in this
subpart, and for the duration of any stay of action on adjudicating the
claims or matters at issue ordered by a court or tribunal of competent
jurisdiction, or the duration of any stay of proceedings granted by an
ALJ or attorney adjudicator on the motion of the appellant, provided no
other party also filed a request for hearing on the same claim at
issue.
We are inviting public comments on these proposals. If you choose
to comment on the proposals in this section, please include the caption
``Section 405.1016: Time frames for deciding an appeal of a QIC or an
escalated request for a QIC reconsideration'' at the beginning of your
comment.
ii. Incorporation of the Provisions of Section 405.1104 (Request for
Council Review When an ALJ Does Not Issue a Decision Timely) Into
Section 405.1016(f)
Current Sec. 405.1104 addresses how to request escalation from an
ALJ to the Council, when an ALJ has not issued a decision, dismissal or
remand on a QIC reconsideration within an applicable adjudication time
frame, in accordance with section 1869(d)(3)(A) of the Act in paragraph
(a); the procedures for escalating an appeal in paragraph (b); and the
status of an appeal for which the adjudication time frame has expired
but the appellant has not requested escalation in paragraph (c). We are
proposing to remove and reserve Sec. 405.1104 and incorporate the
current Sec. 405.1104 providing for escalating a request for an ALJ
hearing to the Council into proposed Sec. 405.1016(e) and (f) with
revisions, as its current placement in the Council portion of part 405,
subpart I has caused confusion. We also are proposing to insert ``or
attorney adjudicator'' after ``ALJ'' in proposed Sec. 405.1016(e) and
(f) to assist appellants in understanding that the effect of exceeding
the adjudication period and the option to escalate would apply to a
request for an ALJ hearing following a QIC reconsideration when the
request has been assigned to an attorney adjudicator, as discussed in
section II.B, above.
Current Sec. 405.1104(c) is titled ``No escalation'' and states
that if the ALJ's adjudication period set forth in Sec. 405.1016
expires, the case remains pending with the ALJ until a decision,
dismissal order, or remand order is issued or the appellant requests
[[Page 43822]]
escalation to the Council. We are proposing in Sec. 405.1016(e) to
incorporate current Sec. 405.1104(c) with changes. We are proposing to
revise the paragraph title for proposed Sec. 405.1016(e) to indicate
that the paragraph discusses the effect of exceeding the adjudication
period. Proposed Sec. 405.1016(e) would provide that if an ALJ or an
attorney adjudicator assigned to a request for hearing (as proposed in
section II.B above) does not issue a decision, dismissal order, or
remand to the QIC within an adjudication period specified in the
section, the party that filed the request for hearing may escalate the
appeal when the adjudication period expires. However, if the
adjudication period expires and the party that filed the request for
hearing does not exercise the option to escalate the appeal, the appeal
remains pending with OMHA for a decision, dismissal order, or remand.
We are proposing to indicate that the appeal remains pending with OMHA
to be inclusive of situations in which the appeal is assigned to an ALJ
or attorney adjudicator, or not yet assigned.
Current Sec. 405.1104(a) describes how to request an escalation
and states that an appellant who files a timely request for hearing
before an ALJ and whose appeal continues to be pending before the ALJ
at the end of the applicable ALJ adjudication period may request
Council review if the appellant files a written request with the ALJ to
escalate the appeal to the Council after the adjudication period has
expired, and the ALJ does not issue a decision, dismissal order, or
remand order within the later of 5 calendar days of receiving the
request for escalation or 5 calendar days from the end of the
applicable adjudication period set forth in Sec. 405.1016. We are
proposing in Sec. 405.1016(f)(1) to remove the requirement to request
Council review in the course of requesting an escalation and to
describe when and how to request escalation. Specifically, we are
proposing to revise the current procedures at Sec. 405.1104(a) and
(a)(1), to provide that an appellant who files a timely request for a
hearing with OMHA and whose appeal continues to be pending at the end
of an applicable adjudication period may exercise the option to
escalate the appeal to the Council by filing a written request with
OMHA to escalate the appeal to the Council, which would simplify the
process for appellants and adjudicators by only requiring appellants to
file a single request for escalation with OMHA. We are proposing to
replace the reference to an appeal that ``continues to be pending
before the ALJ'' in current Sec. 405.1104(a) with an appeal that
``continues to be pending with OMHA'' in proposed Sec. 405.1016(f)(1)
to be inclusive of situations in which the appeal is assigned to an ALJ
or attorney adjudicator, or not yet assigned. We are also proposing
that a written request to escalate an appeal to the Council would be
filed with OMHA to allow OMHA to provide a central filing option for
escalation requests. Current Sec. 405.1106(b) requires that the
appellant send a copy of the escalation request to the other parties
and failing to do so tolls the Council's adjudication deadline set
forth in Sec. 405.1100 until the other parties to the hearing have
received notice. As discussed in section III.A.5.c below, we are
proposing to revise Sec. 405.1106(b) to require that the request for
escalation be sent to other parties who were sent a copy of the QIC
reconsideration. Therefore, we are also proposing at Sec.
405.1016(f)(1) that the appellant would send a copy of the escalation
request to the other parties who were sent a copy of the QIC
reconsideration so appellants would be aware of the requirement and
which parties must be sent a copy of the escalation request.
Current Sec. 405.1104(b) describes the escalation process and
states if the ALJ is not able to issue a decision, dismissal order, or
remand order within the time period set for in paragraph (a)(2) of the
section (later of 5 calendar days of receiving the request for
escalation or 5 calendar days from the end of the applicable
adjudication period set forth in Sec. 405.1016), he or she sends
notice to the appellant acknowledging receipt of the request for
escalation and confirming that the ALJ is not able to issue a decision,
dismissal order, or remand order within the statutory time frame, or if
the ALJ does not act on a request for escalation within the time period
set forth in paragraph (a)(2) of the section or does not send the
required notice to the appellant, the QIC decision becomes the decision
that is subject to Council review consistent with Sec. 405.1102(a).
This process has caused confusion for both appellants and adjudicators
because an initial escalation request must be filed with the ALJ, and
if the ALJ is unable to issue a decision, dismissal or remand within 5
calendar days of receiving the escalation request or within 5 calendar
days from the end of the applicable adjudication period, the appellant
must file a request for Council review to move the appeal to the
Council level, which some appellants do not file. This leaves it
unclear to the ALJ and support staff whether to continue adjudicating
the appeal after issuing a notice that the ALJ is unable to issue a
decision, dismissal or remand within 5 calendar days of receiving the
escalation request. We are proposing in Sec. 405.1016(f)(2) to revise
the escalation process. Specifically, we are proposing that if an
escalation request meets the requirements of proposed Sec.
405.1016(f)(1), and an ALJ or attorney adjudicator is not able to issue
a decision, dismissal order, or remand within the later of 5 calendar
days of receiving the request for escalation or 5 calendar days from
the end of the applicable adjudication period, OMHA (to be inclusive of
situations in which the appeal is assigned to an ALJ or attorney
adjudicator, or not yet assigned) would send a notice to the appellant
stating that an ALJ or attorney adjudicator is not able to issue a
decision, dismissal order, or remand order within the adjudication
period set forth in paragraph (a) or (c) of Sec. 405.1016. We also are
proposing that the notice would state that the QIC reconsideration
would be the decision that is subject to Council review consistent with
Sec. 405.1102(a); and the appeal would be escalated to the Council in
accordance with Sec. 405.1108. OMHA would then forward the case file,
which would include the file received from the QIC and the request for
escalation and all other materials filed with OMHA, to the Council. We
believe that this proposed process would help alleviate the current
confusion, and would simplify the escalation process for appellants
because appellants would not have to file a separate request for
Council review after filing an escalation request with OMHA.
Currently, invalid escalation requests are not addressed in the
regulations. We are proposing in Sec. 405.1016(f)(3) to address
invalid escalation requests. We are proposing that if an ALJ or
attorney adjudicator determines an escalation request does not meet the
requirements of proposed Sec. 405.1016(f)(1), OMHA would send a notice
to the appellant explaining why the request is invalid within 5
calendar days of receiving the request for escalation. For example, an
escalation request would be deemed invalid if escalation is not
available for the appeal, such as appeals of SSA reconsiderations; the
escalation request is premature because the adjudication period has not
expired; or the party that filed the escalation request did not file
the request for hearing. If an ALJ or attorney adjudicator were to
determine the request for escalation was invalid for a reason that
could be corrected (for
[[Page 43823]]
example, if the request was premature), the appellant could file a new
escalation request when the adjudication period expires.
We are inviting public comments on these proposals. If you choose
to comment on the proposals in this section, please include the caption
``Section 405.1016: Escalation of a request for an ALJ hearing'' at the
beginning of your comment.
iii. Section 423.2016: Time frames for Deciding an Appeal of an IRE
Reconsideration
Current Sec. 423.2016 addresses the adjudication time frames for
requests for hearing filed after an IRE has issued its reconsideration.
The title of current Sec. 423.2016 states, ``Timeframes for deciding
an Appeal before an ALJ.'' We are proposing to revise the title of
Sec. 423.2016 to read ``Time frames for deciding an appeal of an IRE
reconsideration'' in order to state that the section addresses
adjudication time frames related to appeals of IRE reconsiderations and
to accommodate the application of this section to attorney
adjudicators, as proposed in Section II.B. above, and as discussed
earlier. We also are proposing to insert ``or attorney adjudicator''
after ``ALJ'' throughout proposed Sec. 423.2016 so that an
adjudication time frame would apply to a request for an ALJ hearing
following an IRE reconsideration when the request has been assigned to
an attorney adjudicator, as discussed in section II.B, above.
Current Sec. 423.2016(a) and (b) explain the adjudication time
frames for standard and expedited appeals of IRE reconsiderations,
respectively. However, the current paragraph titles refer to hearings
and expedited hearings. We are proposing at Sec. 423.2016(a) and (b)
to retitle the paragraphs to refer to standard appeals and expedited
appeals because the time frames apply to issuing a decision, dismissal,
or remand, and are not limited to appeals in which a hearing is
conducted. Similar to proposed Sec. 405.1016, we are proposing at
Sec. 423.2016(a) and (b) to remove ``must'' in providing when an ALJ
or attorney adjudicator issues a decision, dismissal order, or remand
to the IRE, as appropriate, after the request for hearing is received
by the office specified in the IRE's notice of reconsideration because
there may be instances in which a decision, dismissal, or remand cannot
be issued within the adjudication time frame, though we expect those
instances to be rare because beneficiary and enrollee appeals are
generally prioritized by OMHA. In addition, we are proposing in Sec.
423.2016(a) and (b) to replace references to sending a request to the
``entity'' specified in the IRE's reconsideration, with the ``office''
specified in the IRE's reconsideration notice, to minimize confusion
and delays in filing requests with OMHA. Similar to proposed Sec.
405.1016(b)(2), we are proposing at Sec. 423.2016(a)(3) and (b)(6) to
adopt adjudication time frames for appeals that are remanded by the
Council. Specifically, we are proposing in Sec. 423.2016(a)(3) that if
the Council remands a case and the case was subject to an adjudication
time frame, the remanded appeal would be subject to the same
adjudication time frame beginning on the date that OMHA receives the
Council remand to provide enrollees with an adjudication time frame for
remanded appeals. In Sec. 423.2016(b)(6), we are proposing to require
that if the standards for an expedited appeal continue to be met after
the appeal is remanded from the Council, the 10-day expedited time
frame would apply to an appeal remanded by the Council. If the
standards for an expedited appeal are no longer met, the adjudication
time frame for standard appeals would apply because the criteria for an
expedited hearing are no longer present. Finally, we are proposing at
Sec. 423.2016(b) to revise the expedited appeal request process to
permit an ALJ or attorney adjudicator to review a request for an
expedited hearing, but not require the same ALJ or attorney adjudicator
to adjudicate the expedited appeal, to provide OMHA with greater
flexibility to review and assign requests for expedited hearings, and
help ensure the 10-day adjudication process is completed as quickly as
the enrollee's health requires. For example, if an attorney adjudicator
were to review a request for an expedited hearing and determine that
the standards for an expedited hearing were met, but did not believe a
decision could be issued without a hearing, the attorney adjudicator
could provide the enrollee with notice that the appeal would be
expedited and transfer the appeal to an ALJ for an expedited hearing
and decision.
As described in section III.A.3.q below, we are proposing to move
the provision for waiving the adjudication period from current Sec.
423.2036(d) to proposed Sec. 423.2016(c) because proposed Sec.
423.2016 addresses adjudication time frames and we believe the section
is a better place for discussing adjudication time frame waivers.
We are proposing that the provisions of proposed Sec. 405.1016(d)
be adopted in proposed Sec. 423.2016(c) for adjudication period
waivers and stays of the proceedings ordered by a court or granted by
an ALJ or attorney adjudicator on motion by an enrollee.
We are inviting public comments on these proposals. If you choose
to comment on the proposals in this section, please include the caption
``Section 423.2016: Time frames for deciding an appeal of an IRE
reconsideration'' at the beginning of your comment.
i. Submitting Evidence (Sec. Sec. 405.1018 and 423.2018)
Current Sec. Sec. 405.1018 and 423.2018 address submitting
evidence before an ALJ hearing is conducted. We are proposing to
retitle the sections from ``Submitting evidence before the ALJ
hearing'' to ``Submitting evidence'' because evidence may be submitted
and considered in appeals for which no hearing is conducted by an ALJ,
and we believe an attorney adjudicator should be able to consider
submitted evidence in deciding appeals as proposed in section II.B
above. For the same reason, we are proposing in Sec. 423.2018 to
replace the references to ``hearings'' in the heading to paragraph (a)
and in the introductory text to paragraphs (b) and (c), with
``appeals.'' We are also proposing to add headings to paragraphs that
do not currently have headings, for clarity of the matters addressed in
the paragraphs.
Current Sec. 405.1018(a) states that, except as provided in this
section, parties must submit all written evidence they wish to have
considered at the hearing with the request for hearing (or within 10
calendar days of receiving the notice of hearing). We are proposing in
Sec. 405.1018(a) to provide for the submission of other evidence, in
addition to written evidence, that the parties wish to have considered.
Other evidence could be images or data submitted on electronic media.
This revision would also be adopted in proposed Sec. 405.1018(b) and
Sec. 423.2018(a), (b), and (c). We are also proposing in Sec.
405.1018(a) to remove ``at the hearing'' so that parties would submit
all written or other evidence they wish to have considered, and
consideration of the evidence would not be limited to the hearing. We
are proposing a corresponding change at proposed Sec. 423.2018(a).
Current Sec. 405.1018(a) states that evidence must be submitted
with the request for hearing, or within 10 calendar days of receiving
the notice of hearing. This provision has caused confusion as to when
evidence is required to have been submitted
[[Page 43824]]
because current Sec. 405.1014(a)(7) allows an appellant to state in
the request for hearing that additional evidence will be submitted and
the date it will be submitted. To reconcile the provisions, we are
proposing in Sec. 405.1018(a) to provide that parties must submit all
written or other evidence they wish to have considered with the request
for hearing, by the date specified in the request for hearing in
accordance with proposed Sec. 405.1014(a)(2), or if a hearing is
scheduled, within 10 calendar days of receiving the notice of hearing.
We also are proposing that these revisions would be adopted in proposed
Sec. 423.2018(b) and (c).
Current Sec. 405.1018(b) addresses how the submission of evidence
impacts the adjudication period, and provides that if evidence is
submitted later than 10 calendar days after receiving the notice of
hearing, the period between when the evidence ``was required to have
been submitted'' and the time it is received does not count towards an
adjudication period. To simplify the provision, we are proposing at
Sec. 405.1018(b) that if evidence is submitted later than 10 calendar
days after receiving the notice of hearing, any applicable adjudication
period is extended by the number of calendar days in the period between
10 calendar days after receipt of the notice of hearing and the day the
evidence is received. This revision would also be adopted in proposed
Sec. 423.2018(b)(2) and (c)(2), except that in (c)(2), the
adjudication time frame is affected if the evidence is submitted later
than 2 calendar days after receipt of the notice of expedited hearing
because 2 calendar days is the equivalent time frame to submit evidence
for expedited appeals before the adjudication period is affected under
current Sec. 423.2018.
Current Sec. 405.1018(c) addresses new evidence, and is part of
the implementation of section 1869(b)(3) of the Act, which precludes a
provider or supplier from introducing evidence after the QIC
reconsideration unless there is good cause that prevented the evidence
from being introduced at or before the QIC's reconsideration. These
provisions, which provide for the early submission of evidence, allow
adjudicators to obtain evidence necessary to reach the correct decision
as early in the appeals process as possible. We are proposing to
incorporate current Sec. 405.1018(c), which requires a provider,
supplier, or beneficiary represented by a provider or supplier that
wishes to introduce new evidence to submit a statement explaining why
the evidence was not previously submitted to the QIC, or a prior
decision-maker, in proposed Sec. 405.1018(c)(1). However, current
Sec. 405.1018 does not address the consequences of not submitting the
statement. The statute sets a bar to introducing new evidence, and the
submitting party must establish good cause by explaining why the
evidence was not previously submitted to the QIC, or a prior decision-
maker. However, when a provider or supplier, or beneficiary represented
by a provider or supplier, fails to include the required statement,
OMHA ALJs and staff spend time seeking out the explanation and
following up with parties to fulfill their obligation. Thus, we are
proposing to revise Sec. 405.1018(c)(2) to state that if the provider
or supplier, or beneficiary represented by a provider or supplier fails
to include the statement explaining why the evidence was not previously
submitted, the evidence would not be considered. Because only the
enrollee is a party to a Part D appeal, there is no corresponding
provision in proposed Sec. 423.2016.
We are inviting public comments on these proposals. If you choose
to comment on the proposals in this section, please include the caption
``Submitting evidence'' at the beginning of your comment.
j. Time and Place for a Hearing Before an ALJ (Sec. Sec. 405.1020 and
423.2020)
As the ALJ hearing function transitioned from SSA, where hearings
could be held at over 140 hearing sites nation-wide, to OMHA with four
field offices, OMHA became one of the first agencies to use video-
teleconferencing (VTC) as the default mode of administrative hearings.
The effective use of VTC mitigated OMHA's reduced geographic presence,
and allowed OMHA to operate more efficiently and at lower cost to the
American taxpayers. However, the preference of most appellants quickly
turned to hearings conducted by telephone. In FY 2015, over 98% of
hearings before OMHA ALJs were conducted by telephone. Telephone
hearings provide parties and their representatives and witnesses with
the opportunity to participate in the hearing process with minimal
disruption to their day, and require less administrative burden at even
lower cost to the American taxpayers than hearings conducted by VTC.
OMHA ALJs also prefer telephone hearings in most instances, because
they allow more hearings to be conducted without compromising the
integrity of the hearing. However, when the ALJ conducting the hearing
believes visual interaction is necessary for a hearing, he or she may
conduct a VTC hearing, and when special circumstances are presented,
ALJs may conduct in-person hearings.
Despite the shift in preferences for most appellants to telephone
hearings, current Sec. 405.1020 still makes VTC the default mode of
hearing, with the option to offer a telephone hearing to appellants. In
fact, some appellants have required the more expensive VTC hearing even
when their representative is presenting only argument and no testimony
is being offered. We believe this is inefficient and results in wasted
time and resources that could be invested in adjudicating additional
appeals, and unnecessarily increases the administrative burdens and
costs on the government for conducting a hearing with little to no
discernable benefit to the parties in adjudicating denials of items or
services that have already been furnished. Based on these
considerations, we are proposing that a telephone hearing be the
default method, unless the appellant is an unrepresented beneficiary.
We believe this balances the costs and administrative burdens with the
interests of the parties, recognizing that unrepresented beneficiaries
may have an increased need and desire to visually interact with the
ALJ.
We are proposing in 405.1020(b) to provide two standards for
determining how appearances are made, depending on whether appearances
are by unrepresented beneficiaries or by individuals other than
unrepresented beneficiaries. The provisions of current Sec.
405.1020(b) would be incorporated into proposed Sec. 405.1020(b)(1)
and revised to be specific to an appearance by an unrepresented
beneficiary who files a request for hearing. We are proposing in
subsection (b)(1) that the ALJ would direct that the appearance of an
unrepresented beneficiary who filed a request for hearing be conducted
by VTC if the ALJ finds that VTC technology is available to conduct the
appearance, unless the ALJ finds good cause for an in-person
appearance. As in the current rule, we also are proposing in Sec.
405.1020(b)(1) to allow the ALJ to offer to conduct a telephone hearing
if the request for hearing or administrative record suggests that a
telephone hearing may be more convenient to the unrepresented
beneficiary. The current standard for determining whether an in-person
hearing should be conducted involves a finding that VTC technology is
not available or special or extraordinary circumstances exist. Because,
absent special or extraordinary circumstances, a hearing could still be
conducted by telephone if VTC technology were unavailable, we are
proposing that the standard for an in-
[[Page 43825]]
person hearing be revised to state that VTC or telephone technology is
not available or special or extraordinary circumstances exist, and the
determination would be characterized as finding good cause for an in-
person hearing, to align with current Sec. 405.1020(i)(5), which
provides for granting a request for an in-person hearing on a finding
of good cause. We also are proposing in Sec. Sec. 405.1020(b)(1) and
405.1020(i)(5) to replace the reference to obtaining the concurrence of
the ``Managing Field Office ALJ'' with the ``Chief ALJ or designee.''
The position of the Managing Field Office ALJ became what is now an
Associate Chief ALJ, see 80 FR 2708, and using ``Chief ALJ or
designee'' would provide OMHA with the flexibility to designate the
appropriate individual regardless of future organizational changes. We
are proposing to adopt these revisions in proposed Sec. Sec.
423.2020(b)(1), for appearances by unrepresented enrollees and
423.2020(i)(5), for when an ALJ may grant a request for an in-person
hearing. We are also proposing in Sec. 405.1020(b)(1) to replace
``videoteleconferencing,'' with ``video-teleconferencing,'' for
consistency with terminology used in Sec. Sec. 405.1000, 405.1036,
423.2000, 423.2020 and 423.2036.
Proposed Sec. 405.1020(b)(2) addresses appearances by an
individual other than an unrepresented beneficiary who files a request
for hearing. We are proposing in Sec. 405.1020(b)(2) that the ALJ
would direct that those individuals appear by telephone, unless the ALJ
finds good cause for an appearance by other means. Further, we are
proposing in Sec. 405.1020(b)(2) that the ALJ may find good cause for
an appearance by VTC if he or she determines that VTC is necessary to
examine the facts or issues involved in the appeal. Also, we are
proposing that the ALJ, with the concurrence of the Chief ALJ or
designee, may find good cause that an in-person hearing should be
conducted if VTC and telephone technology are not available, or special
or extraordinary circumstances exist. We are proposing to adopt these
revisions in Sec. 423.2020(b)(2) for appearances by represented
enrollees, which is more specific than proposed Sec. 405.1020(b)(2)
because only enrollees are parties to appeals under part 423, subpart
U, and the provisions of subsection (b)(2) would apply only to
appearances by represented enrollees.
Current Sec. 405.1020(c)(1) states that the ALJ sends a notice of
hearing. This has caused confusion as to whether the ALJ must
personally sign the notice, or whether it can be sent at the direction
of the ALJ. We believe that the notice may be sent at the direction of
the ALJ, and requiring an ALJ signature adds an unnecessary step in the
process of issuing the notice. Therefore, we are proposing in Sec.
405.1020(c)(1) that a notice of hearing be sent without further
qualification, and to let other provisions indicate the direction that
is necessary from the ALJ in order to send the notice, such as Sec.
405.1022(c)(1), which provides that the ALJ sets the time and place of
the hearing. We are proposing to adopt these provisions in Sec.
423.2020(a)(1).
Current Sec. 405.1020(c)(1) also requires that the notice of
hearing be sent to the parties who filed an appeal or participated in
the reconsideration, any party who was found liable for the services at
issue subsequent to the initial determination, and the QIC that issued
the reconsideration. However, there are instances in which a party who
does not meet the criteria may face liability because the ALJ may
consider a new issue based on a review of the record. To address this,
we are proposing in Sec. 405.1020(c)(1) to add that a party that may
be found liable based on a review of the record must be sent a notice
of hearing. In addition, current Sec. 405.1020 does not address
notices of hearing sent to CMS or a non-QIC contractor. Currently, ALJs
may also send a notice of hearing to CMS or a contractor when the ALJ
believes their input as a participant or party may be beneficial. We
are proposing in Sec. 405.1020(c)(1) that the notice of hearing also
be sent to CMS or a contractor that the ALJ believes would be
beneficial to the hearing. We are not proposing any corresponding
revisions to current Sec. 423.2020(c)(1) because only enrollees are
parties to appeals under part 423, subpart U.
OMHA ALJs have expressed concern that parties and representatives
who appear at a hearing with multiple individuals and witnesses who
were not previously identified, complicate and slow the hearing
process. While a party or representative has considerable leeway in
determining who will attend the hearing or be called as a witness,
prior notice of those individuals is necessary for the ALJs to schedule
adequate hearing time, manage their dockets, and conduct the hearing.
To address these concerns, we are proposing at Sec. 405.1020(c)(2)(ii)
to add a requirement to specify the individuals from the entity or
organization who plan to attend the hearing if the party or
representative is an entity or organization, and at subsection
(c)(2)(iii) to add a requirement to list the witnesses who will be
providing testimony at the hearing, in the response to the notice of
hearing. We also are proposing to consolidate the provisions in current
Sec. 405.1020(c)(2)(i) and (c)(2)(ii) in proposed Sec.
405.1020(c)(2)(i) to simplify the provisions related to the current
requirements for replying to the notice of hearing. Thus, proposed
subsection (c)(2)(i) would require all parties to the ALJ hearing to
reply to the notice by acknowledging whether they plan to attend the
hearing at the time and place proposed in the hearing, or whether they
object to the proposed time and/or place of the hearing. We are
proposing at Sec. 423.2020(c)(2) to adopt corresponding revisions for
an enrollee's or his or her representative's reply to the notice of
hearing.
We also are proposing in Sec. 405.1020(c)(2) to remove the
provision for CMS or a contractor that wishes to participate in the
hearing to reply to the notice of hearing in the same manner as a party
because a non-party may not object to the proposed time and place of
the hearing, or present witnesses. Instead, we are proposing in Sec.
405.1020(c)(3) to require CMS or a contractor that wishes to attend the
hearing as a participant to reply to the notice of hearing by
acknowledging whether it plans to attend the hearing at the time and
place proposed in the notice of hearing, and specifying who from the
entity plans to attend the hearing. We are proposing at Sec.
423.2020(c)(3) to adopt corresponding revisions for CMS', the IRE's, or
the Part D plan sponsor' reply to the notice of hearing when the entity
requests to attend the hearing as a participant.
In discussing a party's right to waive a hearing, current Sec.
405.1020(d) states that a party may waive the right to a hearing and
request that the ALJ issue a decision based on the written evidence in
the record. In light of proposed Sec. 405.1038(b), which would allow
attorney adjudicators to issue decisions in appeals that do not require
hearings on the record without an ALJ conducting a hearing in certain
situations, we are proposing in Sec. 405.1020(d) to state that a party
also may waive the right to a hearing and request a decision based on
the written evidence in the record in accordance with Sec.
405.1038(b), but an ALJ may require the parties to attend a hearing if
it is necessary to decide the case. We are proposing at Sec.
423.2020(d) to adopt corresponding revisions for an enrollee to waive
his or her right to a hearing and request a decision based on the
written evidence in the record in accordance with Sec. 423.2038(b),
but an ALJ could require the enrollee to attend a hearing if it is
necessary to decide the case. These references would direct readers to
[[Page 43826]]
the section that provides the authority for a decision based on the
written record, which would provide them with a complete explanation of
when the authority may be used and notify them that an ALJ or attorney
adjudicator may issue the decision.
In addressing the ALJ's authority to change the time or place of
the hearing if the party has good cause to object, current Sec.
405.1020(e) requires a party to make the request to change the time or
place of the hearing in writing. However, on occasion, a party may need
to request a change on the day prior to, or the day of a hearing due to
an emergency, such as a sudden illness or injury, or inability to get
to a site for the hearing. In this circumstance, we believe an oral
request should be permitted. Therefore, we are proposing in Sec.
405.1020(e)(3) that the request must be in writing, except that a party
may orally request that a hearing be rescheduled in an emergency
circumstance the day prior to or day of the hearing, and the ALJ must
document the oral request in the administrative record. We are
proposing at Sec. 423.2020(e)(3) to adopt a corresponding provision
for an enrollee to orally request a rescheduled standard hearing, and
to modify the documentation requirement, which is currently limited to
documenting oral requests made for expedited hearings, to include all
oral objections.
In addition, current Sec. Sec. 405.1020(e)(4) and 423.2020(e)(4),
which explain the ALJ may change the time or place of the hearing if
the party has good cause, contain a parenthetical that references the
procedures that an ALJ follows when a party does not respond to a
notice of hearing and fails to appear at the time and place of the
hearing. The parenthetical does not appear to address or assist in
understanding the circumstances covered by current Sec. Sec.
405.1020(e)(4) and 423.2020(e)(4), and we, therefore, are proposing to
remove the parenthetical from the respective sections.
Current Sec. Sec. 405.1020(g)(3) and 423.2020(g)(3) provide a list
of examples of circumstances a party might give for requesting a change
in the time or place of the hearing. We have heard from ALJs and
stakeholders that it would be helpful to also include the following two
additional examples: (1) The party or representative has a prior
commitment that cannot be changed without significant expense, in order
to account for circumstances in which travel or other costly events may
conflict with the time and place of a hearing, which the ALJ may
determines warrants good cause for changing the time or place of the
hearing; and (2) the party or representative asserts that he or she did
not receive the notice of hearing and is unable to appear at the
scheduled time and place, which the ALJ may determine warrants good
cause for changing the time or place of the hearing. We are proposing
in Sec. Sec. 405.1020(g)(3)(vii) and (viii), and 423.1020(g)(3)(vii)
and (viii) to add these two examples to address these circumstances. We
believe these additional examples would provide greater flexibility in
the appeals process and better accommodate the needs of appellants.
We are proposing in Sec. Sec. 405.1020(h) and 423.2020(h) to
revise the references to the adjudication ``deadline'' with references
to the adjudication ``period,'' for consistency in terminology with the
specified cross-references.
We are proposing revisions to Sec. 405.1020(i) to align the
provision with proposed Sec. 405.1020(b). We are proposing in Sec.
405.1020(i) that if an unrepresented beneficiary who filed the request
for hearing objects to a VTC hearing or to the ALJ's offer to conduct a
hearing by telephone, or if a party other than an unrepresented
beneficiary who filed the request for hearing objects to a telephone or
VTC hearing, the party must notify the ALJ at the earliest possible
opportunity before the time set for the hearing and request a VTC or
in-person hearing. The party would be required to state the reason for
the objection and the time and/or place that he or she wants an in-
person or VTC hearing to be held, and the request must be in writing.
We are proposing in Sec. 405.1020(i)(4) to incorporate the current
Sec. 405.1020(i)(4) provision that requires the appeal to be
adjudicated within the time frame specified in Sec. 405.1016 if a
request for an in-person or VTC hearing is granted unless the party
waives the time frame in writing. However, we are proposing at Sec.
405.1020(i)(4) to revise the language to more accurately state that the
ALJ issues a ``decision, dismissal, or remand to the QIC,'' rather than
just a ``decision,'' within the adjudication time frame specified in
Sec. 405.1016. We are proposing revisions to Sec. 423.2020(i) to
align the provision with proposed Sec. 423.2020(b). We are proposing
in Sec. 423.2020(i) that if an unrepresented enrollee who filed the
request for hearing objects to a VTC hearing or to the ALJ's offer to
conduct a hearing by telephone, or if a represented enrollee who filed
the request for hearing objects to a telephone or VTC hearing, the
enrollee or representative must notify the ALJ at the earliest possible
opportunity before the time set for the hearing and request a VTC or
in-person hearing. The enrollee would be required to state the reason
for the objection and the time and/or place that he or she wants an in-
person or VTC hearing to be held. We are proposing in Sec.
423.2020(i)(4) to incorporate the current Sec. 423.2020(i)(4)
provision with some modifications so that the appeal would be
adjudicated within the time frame specified in Sec. 423.2016 if a
request for an in-person or VTC hearing is granted unless the party
waives the time frame in writing. We are proposing at Sec.
423.2020(i)(4) to revise the language to more accurately state that the
ALJ issues a ``decision, dismissal, or remand to the IRE,'' rather than
just a ``decision,'' within the adjudication time frame specified in
Sec. 405.1016 and to include requests for VTC hearings as well as
requests for in-person hearings. In addition, we are proposing at
Sec. Sec. 405.1020(i)(5) and 423.2020(i)(5) to provide that upon a
finding of good cause, a hearing would be rescheduled at a time and
place when the party may appear in person or by VTC, to account for
objections to VTC hearings as well as objections to telephone hearings
or offers to conduct a hearing via telephone. We are also proposing to
replace ``concurrence of the Managing Field Office ALJ'' with
``concurrence of the Chief ALJ or a designee'' because the position of
Managing Field Office ALJ was replaced by the position of Associate
Chief ALJ (80 FR 2708) and providing a more general reference would
provide greater flexibility in the future as position titles change.
Current Sec. Sec. 405.1020 and 423.2020 do not address what occurs
when the ALJ changes the time or place of the hearing. We are proposing
at Sec. 405.1020(j) to add a provision titled ``Amended notice of
hearing'' to clarify that, if the ALJ changes or will change the time
and/or place of the hearing, an amended notice of hearing must be sent
to all of the parties who were sent a copy of the notice of hearing and
CMS or its contractors that elected to be a participant or party to the
hearing, in accordance with the procedures of Sec. 405.1022(a), which
addresses issuing a notice of hearing. We are proposing at Sec.
423.2020(j) to add a provision to clarify that, if the ALJ changes or
will change the time and/or place of the hearing, an amended notice of
hearing must be sent to the enrollee and CMS, the IRE, and/or the Part
D plan sponsor in accordance with the procedures of Sec. 423.2022(a),
which addresses issuing a notice of hearing. These would help ensure
that if changes are made to the time or place of the hearing, a new
[[Page 43827]]
notice is issued or waivers are obtained in a consistent manner.
We are inviting public comments on these proposals. If you choose
to comment on the proposals in this section, please include the caption
``Time and place for a hearing before an ALJ'' at the beginning of your
comment.
k. Notice of a Hearing Before an ALJ and Objections to the Issues
(Sec. Sec. 405.1022, 405.1024, 423.2022, and 423.2024)
Current Sec. 405.1022(a) provides that a notice of hearing will be
mailed or personally served to the parties and other potential
participants, but a notice is not sent to a party who indicates in
writing that it does not wish to receive the notice. Current Sec.
423.2022(a) provides that a notice of hearing will be mailed or
otherwise transmitted, or personally served, unless the enrollee or
other potential participant indicates in writing that he or she does
not wish to receive the notice. However, currently Sec. 405.1022(a) is
limiting because it does not contemplate transmitting the notice by
means other than mail or personal service even though technologies
continue to develop and notice could be provided by secure email or a
secure portal. Also, notices must be sent in accordance with any OMHA
procedures that apply, such as procedures to protect personally
identifiable information. In addition, the exception in current Sec.
405.1022(a) does not contemplate a scenario in which a potential
participant indicates that it does not wish to receive the notice, as
is provided for in current Sec. 423.2022(a). We are proposing in
Sec. Sec. 405.1022(a) and 423.2022(a) to address these issues and
align the sections by providing that a notice of hearing would be
mailed or otherwise transmitted in accordance with OMHA procedures, or
personally served, except to a party or other potential participant who
indicates in writing that he or she does not wish to receive the
notice.
Current Sec. Sec. 405.1022(a) and 423.2022(a) provide that a
notice of hearing does not have to be sent to a party who indicates in
writing that it does not wish to receive the notice and that the notice
is mailed or served at least 20 calendar days (for Parts A and B and
for non-expedited Part D hearings), or 3 calendar days (for expedited
Part D hearings) before the hearing. The provisions do not address the
situation where a party wishes to receive the notice, but agrees to the
notice being mailed fewer than 20 calendar days (or 3 calendar days if
expedited) before the hearing, which may be necessary to accommodate an
appellant's request to conduct a hearing in fewer than 20 or 3 calendar
days. We are proposing to revise Sec. Sec. 405.1022(a) and 423.2022(a)
to address this situation by providing the notice is mailed,
transmitted, or served at least 20 calendar days (or 3 calendar days if
expedited) before the hearing unless the recipient agrees in writing to
the notice being mailed, transmitted, or served fewer than 20 calendar
days (or 3 calendar days if expedited) before the hearing. However, we
note that like a recipient's waiver of receiving a notice of hearing, a
recipient's waiver of the requirement to mail, transmit, or serve the
notice at least 20 or 3 calendar days (as applicable) before the
hearing would only be effective for the waiving recipient and does not
affect the rights of other recipients.
Current Sec. 405.1022(b)(1) requires a notice of hearing to
contain a statement of the specific issues to be decided and inform the
parties that they may designate a person to represent them during the
proceedings. These statements of issues take time to develop, and
current Sec. 405.1032, which addresses the issues before an ALJ,
provides that the issues before the ALJ are all the issues brought out
in the initial determination, redetermination, or reconsideration that
were not decided entirely in a party's favor. Current Sec. 405.1032
also permits an ALJ to consider a new issue at the hearing, if notice
of the new issue is provided to all parties before the start of the
hearing. To streamline the notice of hearing, rather than require the
notice of hearing to contain a statement of the specific issues to be
decided, we are proposing in Sec. 405.1022(b)(1) to require the notice
of hearing to include a general statement putting the parties on notice
that the issues before the ALJ include all of the issues brought out in
the initial determination, redetermination, or reconsideration that
were not decided entirely in a party's favor, for the claims specified
in the request for hearing. This is consistent with the standard for
determining the issues before the ALJ in proposed Sec. 405.1032(a).
However, we also are proposing in Sec. 405.1022(b)(1) that the notice
of hearing also would contain a statement of any specific new issues
that the ALJ will consider in accordance with Sec. 405.1032 to help
ensure the parties and potential participants are provided with notice
of any new issues of which the ALJ is aware at the time the notice of
hearing is sent, and can prepare for the hearing accordingly. For
example, if in the request for hearing an appellant raises an issue
with the methodology used to sample claims and extrapolate an
overpayment, and that issue had not been brought out in the initial
determination, redetermination, or reconsideration, the issue would be
a new issue and the specific issue would be identified in the notice of
hearing. To accommodate proposed Sec. 405.1022(b)(1), we are proposing
that the portion of current Sec. 405.1022(b)(1) that requires the
notice of hearing to inform the parties that they may designate a
person to represent them during the proceedings would be re-designated
as Sec. 405.1022(b)(2), and current subsections (b)(2), (b)(3), and
(b)(4) would be re-designated as subsections (b)(3), (b)(4), and
(b)(5), respectively. We are proposing at Sec. 423.2022(b) to adopt
corresponding revisions for notice information in part 423, subpart U
proceedings.
Current Sec. 405.1022(c)(1) provides that if the appellant, any
other party to the reconsideration to whom the notice of hearing was
sent, or their representative does not acknowledge receipt of the
notice of hearing, the ALJ hearing office attempts to contact the party
for an explanation. We are proposing to replace ``ALJ hearing office''
with ``OMHA'' because OMHA is the responsible entity.
Current Sec. 405.1022(c)(2) provides that if a party states that
he or she did not receive the notice of hearing, an amended notice is
sent to him or her. The reference to an amended notice has caused
confusion, as the original notice does not need to be amended unless
the hearing is rescheduled. We are proposing in Sec. 405.1022(c)(2) to
remove the reference to an ``amended'' notice of hearing and provide
that a copy of the notice of hearing is sent to the party. However, if
a party cannot attend the hearing, we are proposing in new Sec.
405.1022(c)(3) that the party may request that the ALJ reschedule the
hearing in accordance with proposed Sec. 405.1020(e), which discusses
a party's objection to the time and place of hearing. We are proposing
at Sec. 423.2022(c) to adopt corresponding revisions for providing a
copy of the notice of hearing if the enrollee did not acknowledge it
and states that he or she did not receive it in part 423, subpart U
proceedings.
Current Sec. 405.1022(c)(2) provides that if a party did not
receive the notice of hearing, a copy of the notice may be sent by
certified mail or email, if available. Current Sec. 423.2022(c)(2)
provides an additional option to send the copy by fax. However, use of
email to send documents that contain a beneficiary's or enrollee's
personally identifiable information is not currently permitted by OMHA
policy, and faxes
[[Page 43828]]
must be sent in accordance with procedures to protect personally
identifiable information. We are proposing in Sec. Sec. 405.1022(c)(2)
and 423.2022(c)(2) to remove the references to using email and fax, and
to add that a notice may be sent by certified mail or other means
requested by the party and in accordance with OMHA procedures. This
would provide the flexibility to develop alternate means of
transmitting the request and allow OMHA to help ensure necessary
protections are in place to comply with HHS information security
policies. Finally, the parenthetical in current Sec. Sec.
405.1022(c)(2) and 423.2022(c)(2) is not applicable. We believe it was
attempting to cross-reference the provision related to requesting a
rescheduled hearing. Therefore, we are proposing in Sec. Sec.
405.1022(c)(2) and 423.2022(c)(2) to remove the parenthetical. As
discussed above, proposed Sec. Sec. 405.1022(c)(3) and 423.2022(c)(3)
would address the option for a party to request a rescheduled hearing
and contain the correct cross-reference.
Current Sec. 405.1024 sets forth the provision regarding
objections by a party to the issues described in the notice of hearing.
Current Sec. 405.1024(b) requires a party to send a copy of its
objection to the issues to all other parties to the appeal. We are
proposing to revise Sec. 405.1024(b) to provide that the copy is only
sent to the parties who were sent a copy of the notice of hearing, and
CMS or a contractor that elected to be a party to the hearing, because
we believe sending a copy of the objection to additional parties is
unnecessary and causes confusion for parties who were not sent a copy
of the notice of hearing. No corresponding change is proposed in Sec.
423.2024 because only the enrollee is a party.
Current Sec. 405.1024(c) states that an ALJ makes a decision on
the objection to the issues either in writing or at the hearing. We are
proposing to revise Sec. 405.1024(c) to add the option for an ALJ to
make a decision on the objections at a prehearing conference, which is
conducted to facilitate the hearing, as well as at the hearing. We
believe this added flexibility would allow ALJs to discuss the
objections with the parties and make a decision on the record before
the hearing at the prehearing conference. However, we note that the
ALJ's decision on an objection to the issues at a prehearing conference
pursuant to proposed Sec. 405.1024(c) would not be subject to the
objection process for a prehearing conference order under Sec.
405.1040(d). A decision on an objection to the issues is not an
agreement or action resulting from the prehearing conference, but
rather the ALJ's decision on a procedural matter for which the ALJ has
discretion, and we do not believe the parties should have a right of
veto through the prehearing conference order objection process. We also
are proposing at Sec. 423.2024(c) to adopt a corresponding revision
for a decision on an objection to the issues in part 423, subpart U
proceedings.
We are inviting public comments on these proposals. If you choose
to comment on the proposals in this section, please include the caption
``Notice of a hearing before an ALJ and objections to the issue'' at
the beginning of your comment.
l. Disqualification of the ALJ or Attorney Adjudicator (Sec. Sec.
405.1026 and 423.2026)
Current Sec. 405.1026 provides a process for a party to request
that an ALJ disqualify himself or herself from an appeal, or for an ALJ
to disqualify himself or herself from an appeal on the ALJ's own
motion. We are proposing to revise Sec. 405.1026 to replace the
current references to conducting a hearing with references to
adjudicating an appeal, to make it is clear that disqualification is
not limited to ALJs or cases where a hearing is conducted to help
ensure that an attorney adjudicator, as proposed in section II.B above,
also cannot adjudicate an appeal if he or she is prejudiced or partial
to any party, or has any interest in the matter pending for decision.
Current Sec. 405.1026(b) requires that, if a party objects to the ALJ
who will conduct the hearing, the party must notify the ALJ within 10
calendar days of the date of the notice of hearing. The ALJ considers
the party's objections and decides whether to proceed with the hearing
or withdraw. However, the current rule does not address appeals for
which no hearing is scheduled and/or no hearing will be conducted.
Therefore, we are proposing to revise Sec. 405.1026(b) to require that
if a party objects to the ALJ or attorney adjudicator assigned to
adjudicate the appeal, the party must notify the ALJ within 10 calendar
days of the date of the notice of hearing if a hearing is scheduled, or
the ALJ or attorney adjudicator any time before a decision, dismissal
order, or remand order is issued if no hearing is scheduled. We also
are proposing to revise Sec. 405.1026(c) to state that an ALJ or
attorney adjudicator is ``assigned'' to adjudicate an appeal, rather
than ``appointed,'' for consistency in terminology, and to replace
``hearing decision'' with ``decision or dismissal'' because not all
decisions are issued following a hearing and an appellant may have
objected in an appeal that was dismissed, for which review may also be
requested from the Council. In addition, we are proposing to add ``if
applicable'' in discussing that the Council would consider whether a
new hearing is held because not all appeals may have had or require a
hearing. We are proposing at Sec. 423.2026 to adopt corresponding
revisions for disqualification of an ALJ or attorney adjudicator in
part 423, subpart U proceedings.
Current Sec. 405.1026 does not address the impact of a party
objection and adjudicator's withdrawal on an adjudication time frame.
The withdrawal of an adjudicator and re-assignment of an appeal will
generally cause a delay in adjudicating the appeal. We are proposing in
new Sec. 405.1026(d) that if the party objects to the ALJ or attorney
adjudicator, and the ALJ or attorney adjudicator subsequently
withdrawals from the appeal, any applicable adjudication time frame
that applies is extended by 14 calendar days. This would allow the
appeal to be re-assigned and for the new adjudicator to review the
appeal. We are proposing at Sec. 423.2026(d) to adopt a corresponding
provision for the effect of a disqualification of an adjudicator on an
adjudication time frame in part 423, subpart U proceedings, but are
proposing that if an expedited hearing is scheduled, the time frame is
extended by 2 calendar days, to balance the need for the newly assigned
adjudicator to review the appeal, and the enrollee's need to receive a
decision as quickly as possible.
We are inviting public comments on these proposals. If you choose
to comment on the proposals in this section, please include the caption
``Disqualification of the ALJ or attorney adjudicator'' at the
beginning of your comment.
m. Review of Evidence Submitted by the Parties (Sec. 405.1028)
Current Sec. 405.1028 addresses the prehearing review of evidence
submitted to the ALJ. We are proposing to revise the title of Sec.
405.1028 to reflect that the regulation would more broadly apply to the
review of evidence submitted by the parties because a hearing may not
be conducted and an attorney adjudicator would review evidence in
deciding appeals as proposed in section II.B above.
Proposed Sec. 405.1028(a) would incorporate current Sec.
405.1028(a) to address new evidence. Current Sec. 405.1028(a) states
that after a hearing is requested but before it is held, the ALJ will
examine any new evidence
[[Page 43829]]
submitted with the request for hearing (or within 10 calendar days of
receiving the notice of hearing) as specified in Sec. 405.1018, by a
provider, supplier, or beneficiary represented by a provider or
supplier to determine whether there was good cause for submitting
evidence for the first time at the ALJ level. However, this provision
and the other provisions in current Sec. 405.1028 do not address the
review of new evidence when no hearing is conducted for an appeal.
Therefore, we are proposing to revise Sec. 405.1028(a) to add Sec.
405.1028(a)(1), (2), (3), and (4), and are proposing in Sec.
405.1028(a)(1) that after a hearing is requested but before it is held
by an ALJ (to reinforce that hearings are only conducted by ALJs), or a
decision is issued if no hearing is held, the ALJ or attorney
adjudicator would review any new evidence. In addition, we are
proposing in Sec. 405.1028(a)(1) to remove the duplicative statement
indicating the review is conducted on ``any new evidence submitted with
the request for hearing (or within 10 calendar days of receiving the
notice of hearing) as specified in Sec. 405.1018,'' because Sec.
405.1018 discusses when evidence may be submitted prior to a hearing
and, as explained in III.A.3.i above, proposed Sec. 405.1018 would
revise the language that is duplicated in current Sec. 405.1028. We
believe that the better approach going forward is simply to reference
Sec. 405.1018 by indicating that the review is conducted on ``any new
evidence submitted in accordance with Sec. 405.1018.'' This would
remind parties that evidence must be submitted in accordance with Sec.
405.1018, while minimizing confusion on which section is authoritative
with regard to when evidence may be submitted.
In a 2012 OIG report on the ALJ hearing process (OEI-02-10-00340),
the OIG reported concerns regarding the acceptance of new evidence in
light of the statutory limitation at section 1869(b)(3) of the Act on
new evidence submitted by providers and suppliers. The OIG concluded
that the current regulations regarding the acceptance of new evidence
provide little guidance and only one example of good cause, and
recommended revising the regulations to provide additional examples and
factors for ALJs to consider when determining good cause.
Section 1869(b)(3) of the Act states that a provider or supplier
may not introduce evidence in any appeal that was not presented at the
QIC reconsideration unless there is good cause which precluded the
introduction of such evidence at or before that reconsideration. This
section presents a Medicare-specific limitation on submitting new
evidence, and therefore limits the authority of an ALJ to accept new
evidence under the broader APA provisions (see 5 U.S.C. 556(c)(3)
(``Subject to published rules of the agency and within its power,
employees presiding at hearings may- . . . receive relevant evidence .
. . .'')). Section 1869(b)(3) of the Act also presents a clear intent
by Congress to limit the submission of new evidence after the QIC
reconsideration, which must be observed.
In light of the OIG conclusion and recommendation and to more
effectively implement section 1869(b)(3) of the Act, we are proposing
to incorporate current Sec. 405.1028(b) in proposed Sec.
405.1028(a)(2) on when an ALJ could find good cause for submitting
evidence for the first time at the OMHA level, and to establish four
additional circumstances in which good cause for submitting new
evidence may be found. We are also proposing to permit an attorney
adjudicator to find good cause because attorney adjudicators would be
examining new evidence in deciding appeals on requests for an ALJ
hearing as proposed in section II.B above, and we believe the same
standard for considering evidence should apply.
We are proposing in Sec. 405.1028(a)(2)(i) to adopt the example in
current Sec. 405.1028(b) and provide that good cause is found when the
new evidence is, in the opinion of the ALJ or attorney adjudicator,
material to an issue addressed in the QIC's reconsideration and that
issue was not identified as a material issue prior to the QIC's
reconsideration.
We are proposing in Sec. 405.1028(a)(2)(ii) to provide that good
cause is found when the new evidence is, in the opinion of the ALJ,
material to a new issue identified in accordance with Sec.
405.1032(b). This would provide parties with an opportunity to submit
new evidence to address a new issue that was identified after the QIC's
reconsideration. However, the authority is limited to ALJs because, as
discussed in proposed Sec. 405.1032, only an ALJ may raise a new issue
on appeal.
We are proposing in Sec. 405.1028(a)(2)(iii) to provide that good
cause is found when the party was unable to obtain the evidence before
the QIC issued its reconsideration and the party submits evidence that,
in the opinion of the ALJ or attorney adjudicator, demonstrates that
the party made reasonable attempts to obtain the evidence before the
QIC issued its reconsideration. For example, if specific medical
records are necessary to support a provider's or supplier's claim for
items or services furnished to a beneficiary, the provider or supplier
must make reasonable attempts to obtain the medical records, such as
requesting records from a beneficiary or the beneficiary's physician
when it became clear the records are necessary to support the claim,
and following up on the request. Obtaining medical records, in some
cases from another health care professional, and submitting those
records to support a claim for services furnished to a beneficiary is a
basic requirement of the Medicare program (see sections 1815(a) and
1833(e) of the Act, and Sec. 424.5(a)(6)), and we expect instances
where records cannot be obtained in the months leading up to a
reconsideration should be rare. If the provider or supplier was unable
to obtain the records prior to the QIC issuing its reconsideration,
good cause for submitting the evidence after the QIC's reconsideration
could be found when the ALJ or attorney adjudicator determines that the
provider or supplier submitted evidence that demonstrates the party
made reasonable attempts to obtain the evidence before the QIC issued
its reconsideration.
We are proposing at Sec. 405.1028(a)(2)(iv) to provide that good
cause is found when the party asserts that the evidence was submitted
to the QIC or another contractor and the party submits evidence that,
in the opinion of the ALJ or attorney adjudicator, demonstrates that
the new evidence was indeed submitted to the QIC or another contractor
before the QIC issued the reconsideration. For example, if a provider
or supplier submitted evidence to the QIC or another contractor and
through administrative error, the evidence is not associated with the
record that is forwarded to OMHA, good cause may be found when the ALJ
or attorney adjudicator determines that the provider or supplier
submitted evidence that demonstrates the new evidence was submitted to
the QIC or another contractor before the QIC issued the
reconsideration.
Finally, we are proposing at Sec. 405.1028(a)(2)(v) to provide
that in circumstances not addressed in proposed paragraphs (i) through
(iv), the ALJ or attorney adjudicator may find good cause for new
evidence when the ALJ or attorney adjudicator determines the party has
demonstrated that it could not have obtained the evidence before the
QIC issued its reconsideration. We expect proposed paragraphs (i)
through (iv) to cover most circumstances in which a provider or
supplier attempts to introduce new evidence after the QIC
reconsideration, but we believe this additional provision is necessary
to allow for a good cause finding in any
[[Page 43830]]
other circumstance that meets the requirements of section 1869(b)(3) of
the Act. Paragraph (v) helps ensure that OMHA fulfills the statutory
requirement by requiring that the ALJ or attorney adjudicator make a
determination on whether the party could have obtained the evidence
before the QIC issued its reconsideration.
To accommodate the new structure of proposed Sec. 405.1028, we are
proposing that current paragraphs (c) and (d) be re-designated as
paragraphs (a)(3) and (a)(4), respectively. In addition, we are
proposing at Sec. 405.1028(a)(4) that notification about whether the
evidence would be considered or excluded applies only when a hearing is
conducted, and notification of a determination regarding new evidence
would be made only to parties and participants who responded to the
notice of hearing, since all parties may not be sent a copy of the
notice of hearing or attend the hearing. We note that if a hearing is
not conducted, whether the evidence was considered or excluded would be
discussed in the decision, pursuant to proposed Sec. 405.1046(a)(1),
as discussed in section III.A.3.v below. We also are proposing at Sec.
405.1028(a)(4) that the ALJ would notify all parties and participants
whether the new evidence would be considered or is excluded from
consideration (rather than only whether the evidence will be excluded
from the hearing) and that this determination would be made no later
than the start of the hearing, if a hearing is conducted. If evidence
is excluded, it is excluded from consideration, not just the hearing,
and evidence may be excluded from consideration even when no hearing is
conducted. We believe that this would provide greater clarity to
parties and participants regarding the ALJ's determination with respect
to new evidence, and the effect of the exclusion of such evidence on
the proceedings.
Current Sec. 405.1028 does not address duplicative evidence.
However, duplicative evidence is a significant challenge for OMHA
because appellants often submit copies of medical records and other
submissions that were filed at prior levels of appeal and are in the
record forwarded to OMHA. While we recognize that appellants want to
ensure the evidence is in the record and considered, we are also
mindful that the APA provides that as a matter of policy, an agency
shall provide for the exclusion of unduly repetitious evidence (see 5
U.S.C. 556(d)).
We are proposing in Sec. 405.1028(b) that the ALJ or attorney
adjudicator may exclude from consideration any evidence submitted by a
party at the OMHA level that is duplicative of evidence already in the
record forwarded to OMHA. In addition to establishing a general policy
for the exclusion of unduly repetitious evidence, this would reduce
confusion as to which of the multiple copies of records to review, and
would reduce administrative burden.
We are inviting public comments on these proposals. If you choose
to comment on the proposals in this section, please include the caption
``Review of evidence submitted by the parties'' at the beginning of
your comment.
n. ALJ Hearing Procedures (Sec. Sec. 405.1030 and 423.2030)
The APA provides an ALJ with the authority to regulate the course
of a hearing, subject to the rules of the agency (see 5 U.S.C.
556(c)(5)). In rare circumstances, OMHA ALJs have encountered a party
or representative that makes it difficult or impossible for the ALJ to
regulate the course of a hearing, or for other parties to present their
side of the dispute. This may occur when a party or representative
continues to present testimony or argument on a matter that is not
relevant to the issues before the ALJ, or on a matter for which the ALJ
believes he or she has sufficient information or on which the ALJ has
already ruled. This may also occur when a party or representative is
uncooperative, disruptive, or abusive during the course of the hearing.
Sections 405.1030 and 423.2030 sets forth the rules that govern ALJ
hearing procedures. We are proposing to revise Sec. Sec. 405.1030(b)
and 423.2030(b) to add provisions to address these circumstances in a
consistent manner that protects the interests of the parties and the
integrity of the hearing process. To accommodate these proposals, we
are proposing to re-designate paragraph (b) in both Sec. Sec. 405.1030
and 423.2030 as paragraph (b)(1), and to be consistent with proposed
Sec. Sec. 405.1018 and 423.2018, would replace the current language
stating that an ALJ may accept ``documents that are material to the
issues'' with ``evidence that is material to the issues,'' because not
all evidence that may be submitted is documentary evidence (for
example, photographs).
We are proposing in Sec. 405.1030(b)(2) to address circumstances
in which a party or representative continues with testimony and
argument that are not relevant to the issues before the ALJ or that
address a matter for which the ALJ believes he or she has sufficient
information or on which the ALJ has already ruled. In these
circumstances, the ALJ may limit testimony and/or argument at the
hearing, and may, at the ALJ's discretion, provide the party or
representative with an opportunity to submit additional written
statements and affidavits on the matter in lieu of testimony and/or
argument at the hearing, within a time frame designated by the ALJ.
Proposed Sec. 405.1030(b)(2) would allow the ALJ to effectively
regulate the course of the hearing by providing the ALJ with the clear
authority to limit testimony and/or argument during the hearing, while
providing an avenue for the ALJ to allow the testimony and/or argument
to be entered into the record. We are proposing at Sec. 423.2030(b)(2)
to adopt a corresponding revision for limiting testimony and argument
at a hearing, and at the ALJ's discretion, provide an opportunity to
submit additional written statements and affidavits in part 423,
subpart U proceedings.
We are proposing at Sec. 405.1030(b)(3) to address circumstances
in which a party or representative is uncooperative, disruptive, or
abusive during the course of the hearing. In these circumstances, we
are proposing that the ALJ would have the clear authority to excuse the
party or representative from the hearing and continue with the hearing
to provide the other parties and participants with the opportunity to
offer testimony and/or argument. However, in this circumstance, the ALJ
would be required to provide the excused party or representative with
an opportunity to submit written statements and affidavits in lieu of
testimony and/or argument at the hearing. Further, the party also would
be allowed to request a copy of the audio recording of the hearing in
accordance with Sec. 405.1042 and respond in writing to any statements
made by other parties or participants and/or testimony of the witnesses
at the hearing, within a time frame designated by the ALJ. These
proposals would allow the ALJ to effectively regulate the course of the
hearing and balance the excused party's right to present his or her
case, present rebuttal evidence, and cross-examine the witnesses of
other parties with allowing the party to submit written statements and
affidavits. We are proposing at Sec. 423.2030(b)(3) to adopt a
corresponding revision for excusing an enrollee or representative who
is uncooperative, disruptive, or abusive during the hearing in part
423, subpart U proceedings.
Current Sec. 405.1030(c) addresses evidence that the ALJ
determines is missing at the hearing, and provides that if the evidence
is in the possession
[[Page 43831]]
of the appellant, and the appellant is a provider, supplier, or a
beneficiary represented by a provider or supplier, the ALJ must
determine whether the appellant had good cause for not producing the
evidence earlier. We are proposing to revise Sec. 405.1030(c) to add
that the ALJ must determine whether the appellant had good cause in
accordance with Sec. 405.1028 for not producing the evidence. Section
1869(b)(3) of the Act applies to limit submission of all new evidence
after the QIC reconsideration by a provider or supplier absent good
cause, and the proposed addition would create consistent application of
the standards for determining whether there is good cause to admit new
evidence, regardless of when the evidence is submitted after the QIC
reconsideration. We are not proposing any corresponding changes to
current Sec. 423.2030(c) because the limitation on new evidence does
not apply in part 423, subpart U proceedings.
Current Sec. 405.1030(d) and (e) discuss what happens if an ALJ
determines there was or was not good cause for not producing the new
evidence earlier. Current Sec. 405.1030(d) provides that if the ALJ
determines that good cause exists, the ALJ considers the evidence in
deciding the case, and the adjudication period is tolled from the date
of the hearing to the date that the evidence is submitted. Current
Sec. 405.1030(e) provides that if the ALJ determines that good cause
does not exist, the evidence is excluded, with no impact on an
applicable adjudication period. Current Sec. 405.1030(d) and (e) have
caused confusion in light of Sec. 405.1018, which indicates that the
adjudication period will be affected if evidence is submitted later
than 10 calendar days after receipt of the notice of hearing, unless
the evidence is submitted by an unrepresented beneficiary. It has also
potentially created an incentive for appellants to disregard Sec.
405.1018 because current Sec. 405.1030(b) appears to allow evidence to
be submitted at the hearing without affecting the adjudication time
frame; and Sec. 405.1030(c) allows the ALJ to stop a hearing
temporarily if there is material evidence missing, with the effect of
tolling the adjudication time frame from the date of the hearing to the
date the evidence is submitted, if the evidence is in the possession of
an appellant who is a provider or supplier or beneficiary represented
by a provider or supplier, and the ALJ finds good cause to admit the
evidence. In addition, OMHA ALJs have expressed concern that current
Sec. 405.1030(e) does not affect the adjudication period when an equal
amount of time is spent reviewing evidence and making a good cause
determination, regardless of whether good cause is found.
Therefore, we are proposing to revise Sec. 405.1030(d) to address
the effect of an evidentiary submission on an adjudication period. We
are proposing in Sec. 405.1030(d) that any applicable adjudication
period is extended in accordance with proposed Sec. 405.1018(b) if an
appellant other than an unrepresented beneficiary submits evidence
pursuant to proposed Sec. 405.1030(b), which generally allows for
submission of evidence at the hearing, or proposed Sec. 405.1030(c),
which specifically addresses evidence that the ALJ determines is
missing at the hearing. Under proposed Sec. 405.1018(b), any
adjudication period that applies to the appeal would be extended by the
number of days starting 10 calendar days after receipt of the notice of
hearing, and ending when the evidence is submitted, whether it is at
the hearing pursuant to proposed Sec. 405.1030(b)(1), or at a later
time pursuant to proposed Sec. 405.1030(c). Proposed Sec. 405.1030(d)
would provide appellants with an incentive to submit evidence they wish
to have considered early in the adjudication process, allow the ALJ to
consider the evidence and effectively prepare for the hearing, and
minimize any delays in the adjudication process resulting from the late
introduction of evidence during the hearing process. Proposed Sec.
405.1030(d) would also remove the potential incentive to disregard
Sec. 405.1018, and reconcile any inconsistency in the effect of a late
evidentiary submission on an applicable adjudication period by
incorporating the Sec. 405.1018 provisions by reference rather than
establishing a different standard for evidence submitted during the
course of or after a hearing. We are proposing at Sec. 423.2030(d) to
adopt a corresponding provision for the effect on an adjudication time
frame when new evidence is submitted by a represented enrollee in a
standard appeal, or an unrepresented or represented enrollee in an
expedited appeal, in accordance with current Sec. 423.2018(b) or (c),
as applicable.
Continuing a hearing is referenced in current Sec. 405.1030(c),
but is not otherwise addressed in part 405, subpart I. We are proposing
in Sec. 405.1030(e)(1) that a hearing may be continued to a later date
and that the notice of the continued hearing would be sent in
accordance with the proposed Sec. 405.1022, except that a waiver of
the notice of hearing may be made in writing or on the record, and the
notice of continued hearing would be sent to the parties and
participants who attended the hearing, and any additional parties or
potential parties or participants the ALJ determines are appropriate.
The notice requirement would help ensure that the general hearing
notice requirements are met for a continued hearing, but allow a waiver
of the notice of hearing to be made in writing or on the record. We
believe the added option of waiving the notice of hearing on the record
in the context of a continued hearing would facilitate scheduling the
continued hearing when all parties and participants who are in
attendance at the hearing agree to the continued hearing date, or
alternatively agree on the record to the notice being mailed,
transmitted, or served fewer than 20 calendar days before the hearing.
In addition, proposed Sec. 405.1030(e)(1) would only require that a
notice of the continued hearing be sent to the participants and parties
who attended the hearing, but would provide the ALJ with the discretion
to also send the notice to additional parties, or potential parties or
participants. We believe that a notice of the continued hearing to a
party, or potential party or participant, who did not attend the
hearing is not necessary unless the ALJ determines otherwise based on
the circumstances of the case. In the event that the appellant
requested the continuance and an adjudication period applies to the
appeal, we are proposing in Sec. 405.1030(e)(2) to provide that the
adjudication period would be extended by the period between the initial
hearing date and the continued hearing date. We believe an appellant's
request for a continuance of the hearing is similar to an appellant's
request to reschedule a hearing, and if the request is granted, the
adjudication period for the appellant's request for hearing should be
adjusted accordingly. We are proposing at Sec. 423.2030(e) to adopt
corresponding provisions for continued hearings in part 423, subpart U
proceedings.
On occasion, after a hearing is conducted, ALJs find that
additional testimony or evidence is necessary to decide the issues on
appeal, or a procedural matter needs to be addressed. Current Sec.
405.1030(f) allows an ALJ to reopen a hearing to receive new and
material evidence pursuant to Sec. 405.986, which requires that the
evidence (1) was not available or known at the time of the hearing, and
(2) may result in a different conclusion. However, current Sec.
405.1030(f) does not provide a mechanism to address procedural matters,
or to obtain
[[Page 43832]]
additional information through evidence or testimony that may have been
available at the time of hearing and may result in a different outcome
but the importance of which was not recognized until after a post-
hearing review of the case. We are proposing in Sec. 405.1030(f)(1) to
remove the ``reopen'' label and provide for a ``supplemental'' hearing
rather than reopening the hearing to distinguish it from reopening a
decision and the standards for reopening a decision. We are also
proposing that a supplemental hearing may be conducted at the ALJ's
discretion at any time before the ALJ mails a notice of decision in
order to receive new and material evidence, obtain additional
testimony, or address a procedural matter. The ALJ would determine
whether a supplemental hearing is necessary, and if one is held, the
scope of the supplemental hearing, including when evidence is presented
and what issues are discussed. In addition, we are proposing at Sec.
405.1030(f)(1) that a notice of the supplemental hearing be sent in
accordance with Sec. 405.1022 to the participants and parties who
attended the hearing, but would provide the ALJ with the discretion to
also send the notice to additional parties, or potential parties or
participants the ALJ determines are appropriate. Similar to the
proposed notice of a continued hearing explained above, we believe that
a notice of the supplemental hearing to a party, or potential party or
participant, who did not attend the hearing is not necessary unless the
ALJ determines otherwise based on the circumstances of the case. In the
event that the appellant requested the supplemental hearing and an
adjudication period applies to the appeal, we are proposing at Sec.
405.1030(f)(2) to provide that the adjudication period would be
extended by the period between the initial hearing date and the
supplemental hearing date. We believe an appellant's request for a
supplemental hearing is similar to an appellant's request for a
continuance or to reschedule a hearing, and if the request is granted,
the adjudication period for the appellant's request for hearing should
be adjusted accordingly. We are proposing at Sec. 423.2030(f) to adopt
corresponding provisions for supplemental hearings in part 423, subpart
U proceedings.
We are inviting public comments on these proposals. If you choose
to comment on the proposals in this section, please include the caption
``ALJ hearing procedures'' at the beginning of your comment.
o. Issues Before an ALJ or Attorney Adjudicator (Sec. Sec. 405.1032
and 423.2032)
Current Sec. Sec. 405.1032 and 423.2032 address the issues that
are before the ALJ. We are proposing to revise the title of the section
to indicate that the proposed provision also would apply to issues
before an attorney adjudicator, as proposed in section II.B above, if
an attorney adjudicator is assigned to an appeal.
Current Sec. 405.1032(a) states that the issues before the ALJ
include all of the issues brought out in the initial determination,
redetermination, or reconsideration that were not decided entirely in a
party's favor. However, when a request for hearing involves a
reconsideration of multiple claims and the appellant does not identify
one or more of the claims that were not decided entirely in the party's
favor at initial determination, redetermination, or reconsideration, it
is unclear whether the ALJ should review all of the claims that were
not decided entirely in the party's favor at initial determination,
redetermination, or reconsideration, or just those claims specified by
the appellant in the request for hearing. An appellant is required to
identify the dates of service for the claims that it wishes to appeal
in its request for hearing under Sec. 405.1014, and some appellants
have indicated that they do not specify a denied claim in a request for
hearing when they agree that the record does not support coverage of
the claim. To address the ambiguity, and in the interest of efficiency
and consistency with Sec. 405.1014, we are proposing in Sec.
405.1032(a) that the issues before the ALJ or attorney adjudicator
include all the issues for the claims or appealed matter (for example,
for appeals that do not involve a claim for items or services furnished
to a beneficiary, such as Medicare Secondary Payer appeals and
terminations of coverage) specified in the request for hearing that
were brought out in the initial determination, redetermination, or
reconsideration that were not decided entirely in a party's favor. We
are proposing at Sec. 423.2032(a) to adopt a corresponding revision
for issues in part 423, subpart U proceedings, except the term claims
is not used because part 423, subpart U appeals do not involve claims.
Current Sec. 405.1032(a) also notes that if evidence presented
before the hearing causes the ALJ to question a favorable portion of
the determination, the ALJ notifies the parties before the hearing and
may consider it an issue at the hearing. As explained in the 2005
Interim Final Rule (70 FR 11462), this provision relates to the
favorable portion of an appealed claim, and that the favorable issue is
a new issue that must meet the requirements of current paragraph (b).
However, in practice, this provision has been read to allow
consideration of separate claims that were decided in a party's favor
at lower appeal levels in multiple-claim appeals, and at times read
independently from paragraph (b). To address this confusion, we are
proposing to move this language in Sec. 405.1032(a) to proposed Sec.
405.1032(b), with the revisions discussed below. We are proposing at
Sec. 423.2032(a) and (b) to adopt corresponding revisions for new
issues in part 423, subpart U proceedings.
Current Sec. 405.1032(b) allows new issues to be considered at the
hearing if: (1) the ALJ notifies the parties about the new issue before
the start of the hearing; (2) the resolution of the new issue could
have a material impact on the claim or claims that are the subject of
the request for hearing; and (3) its resolution is permissible under
the rules governing reopening of determinations and decisions. We are
proposing at Sec. 405.1032(b) to incorporate these provisions, with
the revisions discussed below, as well as the language regarding
consideration of favorable issues moved from current Sec. 405.1032(a),
in a revised structure.
We are proposing in Sec. 405.1032(b)(1) to address when a new
issue may be considered. Specifically, we are proposing that the ALJ
may only consider the new issue, including a favorable portion of a
determination on a claim or appealed matter specified in the request
for hearing, if its resolution could have a material impact on the
claim or appealed matter, and (1) there is new or material evidence
that was not available or known at the time of the determination and
which may result in a different conclusion, or (2) the evidence that
was considered in making the determination clearly shows on its face
that an obvious error was made at the time of the determination. This
would consolidate the current provisions to better convey when a new
issue may be considered, clarify that a new issue relates to a claim or
appealed matter specified in the request for hearing, and provide the
applicable standards from the reopening rules referenced in current
Sec. 405.1032(b)(1)(ii). We are proposing in Sec. 405.1032(b)(1) to
continue to provide that the new issue may be raised by the ALJ or any
party and may include issues resulting from the participation of CMS,
but correct the language so that it also references participation of
CMS
[[Page 43833]]
contractors. We are proposing at Sec. 423.2032(b)(1) to adopt
corresponding revisions for when new issues may be considered in part
423, subpart U proceedings.
We are proposing at Sec. 405.1032(b)(2) to continue to provide
that notice of the new issue must be provided before the start of the
hearing, but would limit the notice to the parties who were or will be
sent the notice of hearing, rather than the current standard to notice
``all of the parties.'' Because notice of the new issue may be made in
the notice of hearing or after the notice of hearing, and parties
generally have 10 calendar days after receipt of the notice of hearing
to submit evidence, we are proposing at Sec. 405.1032(b)(3) to also
provide that if notice of the new issue is sent after the notice of
hearing, the parties would have at least 10 calendar days after
receiving the notice of the new issue to submit evidence regarding the
issue. As provided in proposed Sec. 405.1028(a)(2)(ii), the ALJ would
then determine whether the new evidence is material to the new issue
identified by the ALJ. If an adjudication time frame applies to the
appeal, the adjudication period would not be affected by the submission
of evidence. Further, we are proposing at Sec. 405.1032(b)(3) that if
the hearing is conducted before the time to submit evidence regarding
the issue expires, the record would remain open until the opportunity
to submit evidence expires to provide the parties sufficient time to
submit evidence regarding the issue. We are proposing at Sec.
423.2032(b)(2) and (b)(3) to adopt corresponding provisions for
providing notice of new issues to enrollees and an opportunity to
submit evidence, and to add that an enrollee will have 2 calendar days
after receiving notice of the new issue in an expedited appeal to
submit evidence, which corresponds to the length of time permitted
under proposed Sec. 423.2018(c) to submit evidence after receiving a
notice of expedited hearing.
Current Sec. 405.1032(c) states that an ALJ cannot add any claim,
including one that is related to an issue that is appropriately before
an ALJ, to a pending appeal unless the claim has been adjudicated at
the lower appeal levels and all parties are notified of the new issues
before the start of the hearing. However, in practice, we are unaware
that this provision is used, and to the extent it may be used, we
believe it would be disruptive to the adjudication process, result in
filing requirements not being observed, and risk adjudication of the
same claim by multiple adjudicators. Therefore, we are proposing to
maintain the topic of adding claims to a pending appeal, but replace
the language of current Sec. 405.1032(c), as explained below.
A reconsideration may be appealed for an ALJ hearing regardless of
the number of claims involved in the reconsideration. However, we
recognize that a party may not specify all of the claims from a
reconsideration that he or she wishes to appeal in the party's request
for hearing. We are proposing in Sec. 405.1032(c)(1) to address this
circumstance by providing that claims that were not specified in a
request for hearing may only be added to a pending appeal if the claims
were adjudicated in the same reconsideration that is appealed in the
request for hearing, and the period to request an ALJ hearing for that
reconsideration has not expired, or an ALJ or attorney adjudicator
extends the time to request an ALJ hearing on those claims to be added
in accordance with proposed Sec. 405.1014(e). We believe that this
would result in less disruption to the adjudication process, greater
adherence to filing requirements, and reduce the risk of adjudication
of the same claim by multiple adjudicators. To help ensure that the
copy requirement of proposed Sec. 405.1014(d) is observed, we are
proposing at Sec. 405.1032(c)(2) to require that before a claim may be
added to a pending appeal, the appellant must submit evidence that
demonstrates that the information that constitutes a complete request
for hearing in accordance with Sec. 405.1014(b) and other materials
related to the claim that the appellant seeks to add to the pending
appeal were sent to the other parties to the claim in accordance with
Sec. 405.1014(d). We are proposing at Sec. 423.2032(c) to adopt a
provision corresponding to proposed Sec. 405.1032(c)(1), but we are
not proposing to adopt a provision corresponding to Sec.
405.1032(c)(2) because there is no Sec. 423.2014 requirement for an
enrollee to send a copy of his or her request to others.
Current Sec. 405.1032 does not address issues related to an appeal
that involves a disagreement with how a statistical sample and/or
extrapolation was conducted. When an appeal involves a statistical
sample and an extrapolation and the appellant wishes to challenge how
the statistical sample and/or extrapolation was conducted, as discussed
previously, we are proposing at Sec. 405.1014(a)(3)(iii) to require
the appellant to assert the reasons the appellant disagrees with how
the statistical sampling and/or extrapolation was conducted in the
request for hearing. We are proposing at Sec. 405.1032(d)(1) to
reinforce this requirement by excluding issues related to how the
statistical sample and/or extrapolation were conducted if the appellant
does not comply with Sec. 405.1014(a)(3)(iii). In addition to
reinforcing the proposed requirement at Sec. 405.1014(a)(3)(iii), we
believe that excluding the issue is appropriate because an appellant
should reasonably be aware of whether it disagrees with how the
statistical sampling and/or extrapolation was conducted at the time it
files a request for hearing, and raising the issue later in the
adjudication process or at the hearing can cause significant delays in
adjudicating an appeal because the ALJ may need to conduct additional
fact finding, find it necessary to request participation of CMS or one
of its contractors, and/or call expert witnesses to help address the
issue.
Related to the issues that an ALJ must consider, the 2005 Interim
Final Rule (70 FR 11466) explained that current Sec. 405.1064 was
added to set forth a general rule regarding ALJ decisions that are
based on statistical samples because a decision that is based on only a
portion of a statistical sample does not accurately reflect the entire
record. As discussed in the 2009 Final Rule (74 FR 65328), current
Sec. 405.1064 explains that when an appeal from the QIC involves an
overpayment, and the QIC used a statistical sample in reaching its
reconsideration, the ALJ must base his or her decision on a review of
all claims in the sample. However, while a review of the claims
selected for the sample is necessary to review issues related to a
contested sample and extrapolation, for example to determine whether
the sample claims were appropriately selected for a representative
sample of the universe, current Sec. 405.1064 has been read more
broadly to also require adjudication of each sample claim, regardless
of whether the sample claim was adjudicated favorably at lower appeal
levels. We do not believe adjudicating sample claims that were decided
favorably at lower levels of appeal, or sample claims that are not
appealed by a party, is necessary to adjudicate broader issues with how
sampling and extrapolation was conducted, and the broader reading of
current Sec. 405.1064 results in unnecessary adjudications of claims
that were not appealed.
To clarify what is at issue and what must be considered in appeals
involving statistical sampling and extrapolations, we are proposing to
remove current Sec. 405.1064, and address the matter in Sec.
405.1032(d)(2). We are proposing in Sec. 405.1032(d)(2) that if a
party asserts a disagreement with how the statistical sampling
methodology and
[[Page 43834]]
extrapolation were conducted in the request for hearing, in accordance
with proposed Sec. 405.1014(a)(3)(iii), Sec. 405.1032(a) through (c)
would apply to the adjudication of the sample claims. The result of
applying proposed Sec. 405.1032(a) and (b) would be that only the
sample units that were specified in the request for hearing are
individually adjudicated, subject to a new issue being identified for
an appealed claim. However, proposed Sec. 405.1032(c) would permit
adding sample claims to a pending appeal if they were adjudicated in
the appealed reconsideration and the time to request a hearing on the
reconsideration has not expired, or the ALJ or attorney adjudicator
extends the time to request an ALJ hearing on those claims in
accordance with Sec. 405.1014(e). To incorporate the principle
embodied in current Sec. 405.1064, we are proposing in Sec.
405.1032(d)(2) that in deciding issues related to how a statistical
sample and/or extrapolation was conducted, the ALJ or attorney
adjudicator would base his or her decision on a review of the entire
sample to the extent appropriate to decide the issue. We believe this
more clearly conveys the intent of the rule and recognizes that an
individual adjudication of each claim in the sample is not always
necessary to decide an issue related to how a statistical sample and/or
extrapolation was conducted, such as whether there is documentation so
that the sampling frame can be re-created, as required by the Medicare
Program Integrity Manual (Internet-Only Manual 100-08) (see chapter 8,
Sec. 8.4.4.4.1). We are not proposing any corresponding changes in
Sec. 423.2030 because statistical sampling and extrapolation are not
currently used for matters that are subject to part 423, subpart U
proceedings.
We are inviting public comments on these proposals. If you choose
to comment on the proposals in this section, please include the caption
``Issues before an ALJ or attorney adjudicator'' at the beginning of
your comment.
p. Requesting Information From the QIC or IRE, and Remanding an Appeal
(Sec. Sec. 405.1034, 405.1056, 405.1058, 423.2034, 423.2056, and
423.2058)
Current Sec. Sec. 405.1034 and 423.2034 describe when an ALJ may
request information from, or remand a case to a QIC or IRE. When the
ALJ believes that the written record is missing information that is
essential to resolving the issues on appeal and that information can be
provided only by CMS or its contractors, including an IRE, or the Part
D plan sponsor, current Sec. Sec. 405.1034(a) and 423.2034(a) allow an
ALJ to remand the case to the QIC or IRE that issued the
reconsideration, or retain jurisdiction of the case and request that
the entity forward the missing information to the appropriate hearing
office. The 2005 Interim Final Rule (70 FR 11465) explained that in the
rare instance in which the file lacks necessary technical information
that can only be provided by CMS or its contractors, it was believed
that the most effective way of completing the record is to return the
case, via remand, to the contractor; however, the ALJ also had the
option of asking the entity to forward the missing information to the
ALJ hearing office. In practice, stakeholders have expressed
frustration and concern with the remand provisions because in
accordance with the definition of a remand in Sec. 405.902, a remand
vacates the lower level appeal decision and therefore may require a QIC
or IRE to issue a new reconsideration, for which the appellant must
submit a new request for hearing, which causes additional delay in
reaching finality on the disputed claims. In addition, current
Sec. Sec. 405.1034 and 423.2034 do not address providing notice of a
remand or the effects of a remand.
To address stakeholders' concerns with the current remand
provisions, and areas not addressed in current Sec. Sec. 405.1034 and
423.2034, we are proposing to revise the sections to cover obtaining
information that can be provided only by CMS or its contractors, or the
Part D plan sponsor, and establishing new Sec. Sec. 405.1056 and
405.1058 to address remands to a QIC, and new Sec. Sec. 423.2056 and
423.2058 to address remands to an IRE.
We are proposing in Sec. 405.1034(a) to maintain the current
standards for requesting information that is missing from the written
record when that information can be provided only by CMS or its
contractors, but limit the action to a request for information directed
to the QIC that conducted the reconsideration or its successor (if a
QIC contract has been awarded to a new contractor). In addition, we are
revising Sec. 405.1034(a) to include attorney adjudicators because
attorney adjudicators would be authorized to adjudicate appeals, as
proposed in section II.B. Also, while we are proposing to retain the
definition of ``can be provided only by CMS or its contractors'' in
Sec. 405.1034(a)(2), we are proposing at Sec. 405.1034(a)(1) to
specify that official copies of redeterminations and reconsiderations
that were conducted on the appealed claims can be provided only by CMS
or its contractors. The redetermination and reconsideration are
important documents that establish the issues on appeal, and while the
parties often have copies of them, we believe the record should include
official copies from the contractors. In addition, we are proposing at
Sec. 405.1034(b) to specify that the ALJ or attorney adjudicator would
retain jurisdiction of the case, and the case would remain pending at
OMHA. We are proposing at Sec. 423.2034(a) and (b) to adopt
corresponding provisions for when information may be requested from an
IRE and that jurisdiction is retained at OMHA in part 423, subpart U
proceedings.
We are proposing in Sec. 405.1034(c) that the QIC would have 15
calendar days after receiving the request for information to furnish
the information or otherwise respond to the request for information,
either directly or through CMS or another contractor. This proposal
would provide the ALJ or attorney adjudicator, the QIC, and the parties
with a benchmark for obtaining the information and determining when
adjudication of the case can resume. We are proposing in Sec.
405.1034(d) that, if an adjudication period applies to the appeal in
accordance with Sec. 405.1016, the adjudication period would be
extended by the period between the date of the request for information
and the date the QIC responds to the request or 20 calendar days after
the date of the request, whichever is less. We recognize that other
provisions that extend an applicable adjudication period generally
involve an appellant's action or omission that delays adjudicating an
appeal within an applicable time frame, but we believe that an
extension is also warranted to fully develop the record when the
written record is missing information that is essential to resolving
the issues on appeal, and that 20 calendar days (5 calendar days for
the request to be received by the QIC and 15 calendar days for the QIC
to respond) is a relatively modest delay in order to obtain missing
information that is essential to resolving the appeal. We are proposing
at Sec. 423.2034(c) and (d) to adopt corresponding provisions for the
IRE to furnish the information or otherwise respond to the request for
information, either directly or through CMS or the Part D plan sponsor,
and the effect on any applicable adjudication time frame in part 423,
subpart U proceedings. In addition, we are proposing at Sec.
423.2034(c) and (d) to provide for an accelerated response time frame
for expedited appeals because of the urgency involved. For expedited
appeals, we are proposing that the IRE
[[Page 43835]]
would have 2 calendar days after receiving a request for information to
furnish the information or otherwise respond to the request, and the
extension to the adjudication time frame would be up to 3 calendar
days, to allow for time to transmit the request to the IRE and for the
IRE to respond.
We are proposing to add new Sec. 405.1056 to describe when a
request for hearing or request for review of a QIC dismissal may be
remanded, and new Sec. 405.1058 to describe the effect of a remand. We
are proposing in Sec. 405.1056(a)(1) to permit a remand if an ALJ or
attorney adjudicator requests an official copy of a missing
redetermination or reconsideration for an appealed claim in accordance
with proposed Sec. 405.1034, and the QIC or another contractor does
not furnish the copy within the time frame specified in Sec. 405.1034.
We also are proposing in Sec. 405.1056(a)(2) to permit a remand when
the QIC does not furnish a case file for an appealed reconsideration.
The remand under both provisions would direct the QIC or other
contractor (such as a Medicare Administrative Contractor that made the
redetermination) to reconstruct the record or initiate a new appeal
adjudication. We expect this type of remand to be very rare, but we
believe it is necessary to help ensure a complete administrative record
of the administrative adjudication of a claim. To address the
possibility that the QIC or another contractor is able to reconstruct
the record for a remanded case, we are proposing in Sec.
405.1056(a)(3) to provide that in the situation where a record is
reconstructed by the QIC, the reconstructed record would be returned to
OMHA, the case would no longer be remanded and the reconsideration
would no longer be vacated, and if an adjudication period applies to
the case, the period would be extended by the time between the date of
the remand and the date the case is returned to OMHA because OMHA was
unable to adjudicate the appeal between when it was remanded and when
it was returned to OMHA. This would help ensure that appellants are not
required to re-start the ALJ hearing or dismissal review process in the
event that the QIC or another contractor is able to reconstruct the
record. We are proposing at Sec. 423.2056(a) to adopt corresponding
provisions for remanding cases in which there is a missing appeal
determination or the IRE is unable to furnish the case file in part
423, subpart U proceedings.
On occasion, an ALJ finds that a QIC issued a reconsideration that
addresses coverage or payment issues related to the appealed claim when
a redetermination was required and no redetermination was conducted, or
the contractor dismissed the request for redetermination and the
appellant appealed the contractor's dismissal. In either circumstance,
the reconsideration was issued in error because the appellant did not
have a right to the reconsideration in accordance with current Sec.
405.960, which only provides a right to a reconsideration when a
redetermination is made by a contractor. We do not believe that an
administrative error made by the QIC conveys rights that are not
afforded under the rules. We are proposing in Sec. 405.1056(b) to
address these circumstances so that, if an ALJ or attorney adjudicator
finds that the QIC issued a reconsideration that addressed coverage or
payment issues related to the appealed claim and no redetermination of
the claim was made (if a redetermination was required) or the request
for redetermination was dismissed (and not vacated), the
reconsideration would be remanded to the QIC that issued the
reconsideration, or its successor, to re-adjudicate the request for
reconsideration. We again expect this type of remand to be rare, but
believe it is necessary to correct administrative errors in the
adjudication process. We are proposing at Sec. 423.2056(b) to adopt a
corresponding provision for when an IRE issues a reconsideration that
addresses drug coverage when no redetermination was conducted or a
request for redetermination was dismissed and is appealed to OMHA under
part 423, subpart U.
OMHA ALJs sometimes receive requests for remands from CMS or a
party because the matter can be resolved by a CMS contractor if
jurisdiction of the claim is returned to the QIC. Current Sec.
405.1034 does not address this type of request. We are proposing at
Sec. 405.1056(c)(1) to provide a mechanism for these remands.
Specifically, we are proposing that at any time prior to an ALJ or
attorney adjudicator issuing a decision or dismissal, the appellant and
CMS or one of its contractors, may jointly request a remand of the
appeal to the entity that conducted the reconsideration. We are
proposing that the request include the reasons why the appeal should be
remanded and indicate whether remanding the case would likely resolve
the matter in dispute. Proposed Sec. 405.1056(c)(2) would allow the
ALJ or attorney adjudicator to determine whether to grant the request
and issue the remand, based on his or her determination of whether
remanding the case would likely resolve the matter in dispute. We
believe this added flexibility would allow appellants and CMS and its
contractors to expedite resolution of a disputed claim when there is
agreement to do so. We are proposing at Sec. 423.2056(c) to adopt
corresponding provisions for requested remands in part 423, subpart U
proceedings.
Current Sec. 405.1034(b) provides that if, consistent with current
Sec. 405.1004(b), the ALJ determines that a QIC's dismissal of a
request for reconsideration was in error, the case will be remanded to
the QIC. We are proposing at Sec. 405.1056(d) to incorporate this
provision and proposed Sec. 423.2056(d) would adopt a corresponding
provision to incorporate current Sec. 423.2034(b)(1) for remanding
cases in which an IRE's dismissal of a request for reconsideration was
in error, in part 423, subpart U proceedings. In addition, we are
proposing at Sec. 423.2056(e) to incorporate current Sec.
423.2034(b)(2), which provides that if an enrollee wants evidence of a
change in his or her condition to be considered in the appeal, the
appeal would be remanded to the IRE for consideration of the evidence
on the change in condition.
Current Sec. 405.1034(c) provides that the ALJ remands an appeal
to the QIC that made the reconsideration if the appellant is entitled
to relief pursuant to 42 CFR 426.460(b)(1), 426.488(b), or
426.560(b)(1), and provides that unless the appellant is entitled to
such relief, the ALJ applies the LCD or NCD in place on the date the
item or service was provided. We are proposing to incorporate these
provisions at Sec. 405.1056(e). We did not propose any corresponding
provision for Sec. 423.2056 because there is not a similar current
provision for part 423, subpart U proceedings.
As noted above, current Sec. 405.1034 does not address providing a
notice of remand. We are proposing at Sec. 405.1056(f) to provide that
OMHA mails or otherwise transmits a written notice of the remand of the
request for hearing or request for review to all of the parties who
were sent a copy of the request at their last known address, and CMS or
a contractor that elected to be a participant to the proceedings or a
party to the hearing. The notice would state that, as discussed below,
there is a right to request that the Chief ALJ or a designee review the
remand. We believe this would help ensure that the parties and CMS and
its contractors receive notice that the remand order has been issued.
We are proposing at Sec. 423.2056(f) to adopt a corresponding
provision for a notice of remand in part
[[Page 43836]]
423, subpart U proceedings, except that only the enrollee receives
notice because only the enrollee is a party, and CMS, the IRE, and the
Part D plan sponsor only receive notice if they requested to
participate and the request was granted.
Stakeholders have recounted instances in which they believe a
remand was not authorized by the regulations, but were unable to take
any action to correct the perceived error because a remand is not an
appealable action and current Sec. 405.1034 does not provide a review
mechanism. We do not believe that remands should be made appealable
actions, but recognize that stakeholders need a mechanism to address
remands that they believe are not authorized by the regulation. We are
proposing in Sec. 405.1056(g) to provide a mechanism to request a
review of a remand by allowing a party or CMS, or one of its
contractors, to file a request to review a remand with the Chief ALJ or
a designee within 30 calendar days of receiving a notice of remand. If
the Chief ALJ or designee determines that the remand is not authorized
by Sec. 405.1056, the remand order would be vacated. We are also
proposing that the determination on a request to review a remand order
is binding and not subject to further review so adjudication of the
appeal can proceed. We are proposing at Sec. 423.2056(g) to adopt a
corresponding provision for reviewing a remand in part 423, subpart U
proceedings.
Current Sec. 405.1034 does not discuss the effect of a remand. We
are proposing at Sec. 405.1058, similar to current Sec. Sec. 405.1048
and 405.1054 which describe the effects of a decision and dismissal,
respectively, that a remand of a request for hearing or request for
review is binding unless it is vacated by the Chief ALJ or a designee
in accordance with proposed Sec. 405.1056(g). We believe the provision
would add clarity for the parties and other stakeholders on the effect
of a remand order. We are proposing at Sec. 423.2058 to adopt a
corresponding provision for the effect of a remand in part 423, subpart
U proceedings.
We are inviting public comments on these proposals. If you choose
to comment on the proposals in this section, please include the caption
``Requesting information from the QIC or IRE, and remanding an appeal''
at the beginning of your comment.
q. Description of the ALJ Hearing Process and Discovery (Sec. Sec.
405.1036, 405.1037, and 423.2036)
Current Sec. Sec. 405.1036 and 423.2036 describe the ALJ hearing
process, including the right to appear and present evidence, waiving
the right to appear at the hearing, presenting written statements and
oral arguments, waiver of the adjudication period, what evidence is
admissible at the hearing, subpoenas, and witnesses at a hearing.
Current Sec. 405.1037 describes the discovery process in part 405,
subpart I proceedings, which is permitted when CMS or a contractor
elects to be a party to the ALJ hearing; there is no corresponding
provision for part 423, subpart U proceedings because CMS, the IRE, and
the Part D plan sponsor may not be made parties to the hearing.
Current Sec. 405.1036(b)(1) states that a party may ``send the
ALJ'' a written statement indicating that he or she does not wish to
appear at the hearing. We are proposing at Sec. 405.1036(b)(1) to
revise this provision to state that a party may ``submit to OMHA'' a
written statement indicating that he or she does not wish to appear at
the hearing. While the written statement could still be sent to an ALJ
who is assigned to a request for hearing, we are proposing that the
statement could be submitted to OMHA (for example, the statement could
be submitted with the request for hearing), or to the ALJ or attorney
adjudicator, as proposed in section II.B above, after the request is
assigned, to provide more flexibility and to accommodate situations
where an ALJ or attorney adjudicator has not been assigned a request
for hearing. We are proposing at Sec. 423.2036(b)(1) to adopt a
corresponding revision for submitting a waiver of the right to appear
in part 423, subpart U proceedings. In addition, we are proposing at
Sec. 423.2036(b)(1)(ii) to revise the current requirement for the
``ALJ hearing office'' to document oral requests to require ``OMHA'' to
document oral requests, to help ensure that applicability of the
requirement is clear regardless of whether the oral request is received
by an adjudicator in an OMHA field office after the appeal is assigned
to an ALJ or attorney adjudicator, or the oral request is received in
the OMHA central office before the appeal is assigned to an ALJ or
attorney adjudicator.
As discussed in section III.A.3.h above, we are proposing to move
the provision for waiving the adjudication period from current Sec.
405.1036(d) to proposed Sec. 405.1016(d) because proposed Sec.
405.1016 addresses adjudication time frames and we believe the section
is a better place for discussing adjudication time frame waivers. To
accommodate moving current Sec. 405.1036(d) to proposed Sec.
405.1016(d), we are proposing to re-designate current Sec.
405.1036(g), which describes witnesses at the hearing, as proposed
Sec. 405.1036(d) because it more logically follows the discussion of
presenting witnesses and oral arguments in current Sec. 405.1036(c).
For the same reasons, we are proposing to move the provisions at Sec.
423.2036(d) to proposed Sec. 423.2016(c), and proposing at Sec.
423.2036(d) to re-designate current Sec. 423.2036(g) as proposed Sec.
423.2036(d) to describe witnesses at a hearing in part 423, subpart U
proceedings.
Current Sec. 405.1036(f) discusses subpoenas. Current Sec.
405.1036(f)(5)(i) states that an ALJ ruling on a subpoena request is
not subject to immediate review by the Council and may be reviewed
solely during the course of the Council's review specified in Sec.
405.1102 (for requests for Council review when an ALJ issues a decision
or dismissal), Sec. 405.1104 (for requests for escalation to the
Council), or Sec. 405.1110 (for referrals for own motion review by the
Council). As discussed in section III.A.3.h.ii above, we are proposing
to remove section Sec. 405.1104 and relocate provisions dealing with
escalation to the Council to Sec. 405.1016. Because the process for
requesting escalation to the Council is now described in proposed Sec.
405.1016(e) and (f), we are proposing at Sec. 405.1036(f)(5)(i) to
replace the reference to Sec. 405.1104 with a reference to Sec.
405.1016(e) and (f). Current Sec. 405.1036(f)(5)(ii) discusses CMS
objections to a ``discovery ruling'' in the context of a paragraph on
reviewability of subpoena rulings and current Sec. 405.1037(e)(2)(i)
separately addresses CMS objections to a discovery ruling. We are
proposing to revise Sec. 405.1036(f)(5)(ii) to replace the current
reference to a ``discovery ruling'' with ``subpoena ruling'' so it is
consistent with the topic covered by Sec. 405.1036(f). No
corresponding revisions are necessary in Sec. 423.2036(f) because
there is no reference to a ``discovery ruling.''
Current Sec. 405.1037(a)(1) provides that discovery is permissible
only when CMS or its contractors elects to participate in an ALJ
hearing as a party. While the intent is generally clear, the use of
``participate'' is potentially confusing given CMS or one of its
contractors can elect to be a participant in the proceedings, including
the hearing, in accordance with current and proposed Sec. 405.1010, or
elect to be a party to the hearing in accordance with current and
proposed Sec. 405.1012. We are proposing to revise Sec.
405.1037(a)(1) to state that discovery is permissible only when CMS or
its contractor elects to be a party to an ALJ hearing, in accordance
with proposed Sec. 405.1012. As noted above, there are no provisions
for discovery in part 423, subpart U proceedings because CMS, the IRE,
or
[[Page 43837]]
the Part D plan sponsor are not permitted to be a party to the hearing.
Current Sec. 405.1037(e)(1) states that an ALJ discovery ruling or
disclosure ruling is not subject to immediate review by the Council and
may be reviewed solely during the course of the Council's review
specified in Sec. 405.1100 (for Council review in general), Sec.
405.1102 (for requests for Council review when an ALJ issues a decision
or dismissal), Sec. 405.1104 (for requests for escalation to the
Council), or Sec. 405.1110 (for referrals for own motion review by the
Council). For the reasons discussed above with regard to similar
proposed changes in Sec. 405.1036, we are proposing at Sec.
405.1037(e)(1) to replace the reference to Sec. 405.1104 with a
reference to Sec. 405.1016(e) and (f).
Current Sec. 405.1037(f) describes the effect of discovery on an
adjudication time frame, and provides that the time frame is tolled
until the discovery dispute is resolved. However, it does not clearly
state when the effect on an adjudication time frame begins, and
``discovery dispute'' is not used elsewhere in the section. In
addition, current Sec. 405.1037(f) does not contemplate that an
adjudication time frame may not apply (for example, when the
adjudication time frame is waived in accordance with proposed Sec.
405.1016(d)). Therefore, we are proposing to revise Sec. 405.1037(f)
to state that if an adjudication period applies to the appeal in
accordance with Sec. 405.1016, and a party requests discovery from
another party to the hearing, the adjudication period is extended for
the duration of discovery, from the date a discovery request is granted
until the date specified for ending discovery. We believe this revision
would provide a clearer standard for how an adjudication period is
affected by discovery proceedings.
We are inviting public comments on these proposals. If you choose
to comment on the proposals in this section, please include the caption
``Description of the ALJ hearing process and discovery'' at the
beginning of your comment.
r. Deciding a Case Without a Hearing Before an ALJ (Sec. Sec. 405.1038
and 423.2038)
Current Sec. 405.1038(a) provides authority to issue a ``wholly
favorable'' decision without a hearing before an ALJ and without giving
the parties prior notice when the evidence in the hearing record
supports a finding in favor of the appellant(s) on every issue. We are
proposing in Sec. 405.1038 that if the evidence in the administrative
record supports a finding in favor of the appellant(s) on every issue
and no other party to the appeal is liable for claims at issue, an ALJ
or attorney adjudicator, as proposed in section II.B above, may issue a
decision without giving the parties prior notice and without an ALJ
conducting a hearing, unless CMS or a contractor has elected to be a
party to the hearing in accordance with Sec. 405.1012. Proposed Sec.
405.1038(a) would replace ``wholly favorable'' with ``fully favorable''
in the subsection heading to align with language in Sec. 405.1000(g),
which addresses a fully favorable decision being made on the record,
and the nomenclature used in OMHA's day to day operations. Proposed
Sec. 405.1038(a) would also replace ``hearing record'' with
``administrative record'' for consistency with other references to the
record, and replace ``hearing decision'' with ``decision,'' for
consistency with other references to a decision. We are proposing at
Sec. 423.2038(a) to adopt corresponding revisions to align with
language in Sec. 423.2000(g) and to make references to the record and
decisions consistent in part 423, subpart U proceedings.
Proposed Sec. 405.1038(a) would also add two new limitations on
issuing a decision without a hearing before an ALJ when the evidence in
the administrative record supports a finding in favor of the
appellant(s) on every issue. First, a decision could not be issued
pursuant to proposed Sec. 405.1038(a) if another party to the appeal
is liable for the claims at issue. Second, a decision could not be
issued pursuant to proposed Sec. 405.1038(a) if CMS or a contractor
elected to be a party to the hearing in accordance with Sec. 405.1012.
We recognize that this may limit decisions that may be issued pursuant
to Sec. 405.1038(a); however, we believe only a small number of
appeals would be affected, and the new limitations would mitigate the
impact of such a decision on the other parties to the appeal and the
likelihood of an appeal to, and remand from, the Council. No
corresponding changes are proposed in Sec. 423.2038(a) because only
the enrollee is a party in part 423, subpart U proceedings.
Current Sec. 405.1038(b)(1) permits the ALJ to decide a case on
the record and not conduct a hearing if: (1) All the parties indicate
in writing that they do not wish to appear before the ALJ at a hearing,
including a hearing conducted by telephone or video-teleconferencing,
if available; or (2) an appellant lives outside of the United States
and does not inform the ALJ that he or she wants to appear, and there
are no other parties who wish to appear. We are proposing to retain
this structure in proposed Sec. 405.1038(b) but are proposing some
changes. Current Sec. 405.1038(b)(1)(i) requires all parties to
indicate in writing that they do not wish to appear before the ALJ at a
hearing, and as indicated above, current Sec. 405.1038(b)(1)(ii) is
contingent on no other parties wishing to appeal. However, the
requirement to obtain a writing from all parties or determine the
wishes of the non-appellant parties has limited the utility of the
provisions. While all parties have a right to appear at the hearing, a
notice of hearing is not sent to parties who did not participate in the
reconsideration and were not found liable for the items or services at
issue after the initial determination, in accordance with current Sec.
405.1020(c). We are proposing at Sec. 405.1038(b)(1)(i) and (b)(1)(ii)
to modify the requirements so writings only need to be obtained from,
or wishes assessed from, parties who would be sent a notice of hearing,
if a hearing were to be conducted. Using the notice of hearing standard
protects the interests of potentially liable parties, while making the
provisions a more effective option for the efficient adjudication of
appeals. In addition, proposed Sec. 405.1038(b)(1) would reinforce
that only an ALJ conducts a hearing by indicating an ALJ or attorney
adjudicator may decide a case on the record without an ALJ conducting a
hearing. Proposed Sec. 405.1038(b)(1)(ii) also would indicate that an
appellant who lives outside of the United States would inform ``OMHA''
rather than ``the ALJ'' that he or she wants to appear at a hearing
before an ALJ, so an appellant could make that indication before an
appeal is assigned to an ALJ or attorney adjudicator. We are proposing
at Sec. 423.2038(b)(1) and (b)(1)(ii) to adopt corresponding revisions
to reinforce that only an ALJ conducts a hearing and an enrollee who
lives outside of the United States would inform OMHA that he or she
wishes to appear at a hearing before an ALJ, but the other changes in
proposed Sec. 405.1038(b) are not made to Sec. 423.2038(b) because
only the enrollee is a party in part 423, subpart U proceedings. We are
also proposing in Sec. 405.1038(b)(1)(i) to replace
``videoteleconferencing,'' and in Sec. 423.2038(b)(1)(i) to replace
``video teleconferencing,'' with ``video-teleconferencing,'' for
consistency with terminology used in Sec. Sec. 405.1000, 405.1036,
423.2000, 423.2020, and 423.2036.
On occasion, CMS or one of its contractors indicates that it
believes an item or service should be covered or payment made on an
appealed claim,
[[Page 43838]]
either before or at a hearing. However, there are no current provisions
that address this circumstance and it is one that is ideal for a
summary decision in favor of the parties based on the statement by CMS
or its contractor, in lieu of a full decision that includes findings of
fact, conclusions of law, and other decision requirements. We are
proposing to add Sec. 405.1038(c) to provide a new authority for a
stipulated decision, when CMS or one of its contractors submits a
written statement or makes an oral statement at a hearing indicating
the item or service should be covered or paid. In this situation, an
ALJ or attorney adjudicator may issue a stipulated decision finding in
favor of the appellant or other liable parties on the basis of the
statement, and without making findings of fact, conclusions of law, or
further explaining the reasons for the decision. We are proposing at
Sec. 423.2038(c) to adopt a corresponding authority for stipulated
decisions in part 423, subpart U proceedings.
We are inviting public comments on these proposals. If you choose
to comment on the proposals in this section, please include the caption
``Deciding a case without a hearing before an ALJ'' at the beginning of
your comment.
s. Prehearing and Posthearing Conferences (Sec. Sec. 405.1040 and
423.2040)
Current Sec. 405.1040 discusses prehearing and posthearing
conferences and permits the ALJ to hold these conferences to facilitate
the hearing or hearing decision. Current Sec. 405.1040(b) requires an
ALJ to inform ``the parties'' of the time, place, and purpose of the
prehearing or posthearing conference, unless a party indicates in
writing that it does not wish to receive a written notice of the
conference. In accordance with current Sec. 405.1020(c), the notice of
hearing is not sent to a party who did not participate in the
reconsideration and was not found liable for the services at issue
after the initial determination. Therefore, we are proposing to modify
Sec. 405.1040(b) to state that the ALJ would inform parties who would
be or were sent a notice of hearing in accordance with Sec.
405.1020(c). In addition, current Sec. 405.1040(b) does not provide
for conference notice to be sent to CMS or a contractor that elected to
be a participant in the proceedings or a party to the hearing at the
time the conference notice is sent, which has caused confusion when CMS
or a contractor has made an election before or after a conference.
Therefore, we are proposing at Sec. 405.1040(b) that a conference
notice be sent to CMS or a contractor that has elected to be a
participant in the proceedings or a party to the hearing at the time
the conference notice is sent. We believe these changes would help
ensure the appropriate parties and participants are provided with
notice of, and have an opportunity to attend, a conference. We are
proposing at Sec. 423.2040(b) and (c) to adopt corresponding revisions
for prehearing conference notices in non-expedited and expedited
hearings respectively to state that a conference notice is sent to CMS,
the IRE, and/or the Part D plan sponsor if the ALJ has granted their
request(s) to be a participant in the hearing, but we are not proposing
to make other changes in proposed Sec. 405.1040(b) to Sec. 423.2040
because only the enrollee is a party in part 423, subpart U
proceedings. In addition, because an oral request not to receive a
notice of the conference is permitted for expedited hearings, we are
proposing at Sec. 423.2040(d) to revise the requirement for an ``ALJ
hearing office'' to document such an oral request to provide more
generally that oral requests must be documented, which is generally
done by the ALJ's support staff, rather than other office staff. In
addition, we are proposing at Sec. 423.2040(d) that documentation of
an oral request not to receive written notice of the conference must be
added to the administrative record for consistency in how the record is
referenced.
Current Sec. 405.1040(c) states that, at the conference, the ALJ
may consider matters in addition to those stated in the notice of
hearing, if the parties consent in writing. However, OMHA ALJs have
indicated that providing them with the discretion to delegate
conducting a conference to an attorney would add efficiency to the
process. OMHA attorneys are licensed attorneys who support ALJs in
evaluating appeals and preparing appeals for hearing, as well as
drafting decisions, and are well versed in Medicare coverage and
payment policy, as well as administrative procedure. Therefore, we are
proposing at Sec. 405.1040(c)(1) that, at the conference, the ALJ or
an OMHA attorney designated by the ALJ may conduct the conference, but
only the ALJ conducting a conference may consider matters in addition
to those stated in the conference notice if the parties consent to
consideration of the additional matters in writing. This revision would
allow an OMHA attorney designated by the ALJ assigned to an appeal to
conduct a conference, but would only allow an ALJ conducting the
conference to consider matters in addition to those stated in the
conference notice. We believe allowing ALJs to delegate the task of
conducting a conference (consistent with the conference notice stating
the purpose of the conference, in accordance with Sec. 405.1040(b))
would provide ALJs with the flexibility to use OMHA attorneys and
provide ALJs with more time to devote to hearings and decisions. We
also believe using attorneys to conduct conferences is appropriate
because conferences are informal proceedings to facilitate a hearing or
decision, and do not involve taking testimony or receiving evidence,
both of which occur at the hearing. We also note that the results of
the conference embodied in a conference order are subject to review and
approval by the ALJ, and ultimately subject to an objection by the
parties, under the provisions of current Sec. 405.1040, which are
carried over in proposed Sec. 405.1040. We are proposing at Sec.
423.2040(e)(1) to adopt corresponding revisions for allowing an ALJ to
delegate conducting a conference to an OMHA attorney, in part 423,
subpart U proceedings.
Current Sec. 405.1040(c) references the notice of hearing in
discussing the matters that are considered at a conference. However, a
notice of hearing may not have been issued at the time a prehearing
conference is scheduled, and the matters being addressed in the appeal
may have evolved since a notice of hearing was issued by the time a
posthearing conference is scheduled, resulting in confusion on the
permissible scope of the matters discussed at a conference. Therefore,
Sec. 405.1040(c)(1) would state that the matters that are considered
at a conference are those stated in the conference notice (that is, the
purpose of the conference, as discussed in current Sec. 405.1040(b)).
Current Sec. 405.1040(c) states that a record of the conference is
made. However, that requirement has been read and applied differently
by adjudicators. We are proposing at Sec. 405.1040(c)(2) to require
that an audio recording of the conference be made to establish a
consistent standard and because the audio recording is the most
administratively efficient way to make a record of the conference. We
are proposing at Sec. 423.2040(e)(1) and (e)(2) to adopt corresponding
revisions to reference a conference notice and clarify that an audio
recording of the conference is made in part 423, subpart U proceedings.
Current Sec. 405.1040(d) requires the ALJ to issue an order
stating all agreements and actions resulting from the conference. If
the parties do not object, the agreements and actions become part of
the hearing record and are binding on
[[Page 43839]]
all parties. It does not state to whom a conference order is issued,
and again broadly references parties in indicating who may object to
the order. In addition, current Sec. 405.1040(d) does not establish a
time period within which an objection must be made before the order
becomes part of the record and binding on the parties. Therefore, we
are proposing to revise Sec. 405.1040(d) to state that the ALJ issues
an order to all parties and participants who attended the conference
stating all agreements and actions resulting from the conference. If a
party does not object within 10 calendar days of receiving the order,
or any additional time granted by the ALJ, the agreements and actions
become part of the administrative record and are binding on all
parties. Proposed Sec. 405.1040(d) would provide that the order is
issued to the parties and participants who attended the conference to
help ensure the appropriate parties and participants receive the order,
but as in current Sec. 405.1040(d), only a party could object to the
order. Proposed Sec. 405.1040(d) would also establish that an
objection must be made within 10 calendar days of receiving the order
to establish a consistent minimum standard for making objection to a
conference order, but would also provide the ALJ with the discretion to
grant additional time. In addition, proposed Sec. 405.1040(d) would
replace ``hearing record'' with ``administrative record'' for
consistency with other references to the record. Further, proposed
Sec. 405.1040(d) would continue to only allow the ALJ to issue a
conference order, because we believe the ALJ should review and approve
the actions and agreements resulting from the conference, and only an
ALJ should issue an order that would be binding on the parties, if no
objection is made. We are proposing at Sec. 423.2040(f) to adopt
corresponding revisions to clarify to whom a conference order is sent
and the time frame to object to the order, and to specify that
agreements and actions resulting from the conference become part of the
``administrative record'' (rather than ``hearing record'') in part 423,
subpart U proceedings. However, we are proposing to add that an
enrollee must object to a conference order within 1 calendar day of
receiving the order for expedited hearings because of the abbreviated
time frame under which an expedited hearing and decision must be
completed.
We are inviting public comments on these proposals. If you choose
to comment on the proposals in this section, please include the caption
``Prehearing and posthearing conferences'' at the beginning of your
comment.
t. The Administrative Record (Sec. Sec. 405.1042 and 423.2042)
The administrative record is HHS's record of the administrative
proceedings, and is initially established by OMHA ALJs and built from
the records of CMS contractors that adjudicated the claim, or from
records maintained by SSA in certain circumstances. After adjudication
by OMHA, the Council may include more documents in the administrative
record, if a request for Council review is filed or a referral to the
Council is made. If a party then seeks judicial review, the
administrative record is certified and presented to the Court as the
official agency record of the administrative proceedings. The record is
returned to the custody of CMS contractors or SSA after any
administrative and judicial review is complete. Current practices in
creating the administrative record in accordance with current
Sec. Sec. 405.1042 and 423.2042 vary widely. Given the importance of
the administrative record, we are proposing to revise Sec. Sec.
405.1042 and 423.2042 to provide for more consistency and to clarify
its contents and other administrative matters.
Current Sec. 405.1042(a)(1) provides that the ALJ makes a complete
record of the evidence, including the hearing proceedings, if any.
However, this provision has been limiting and causes confusion in
developing procedures to ensure the completeness of the record and in
bringing consistency to how the record is structured because individual
adjudicators organize the record differently. We are proposing to
revise Sec. 405.1042(a)(1) to require OMHA to make a complete record
of the evidence and administrative proceedings on the appealed matter,
including any prehearing and posthearing conferences, and hearing
proceedings that were conducted. Proposed Sec. 405.1042(a)(1) would
vest OMHA, rather than the ALJ, with the responsibility of making a
complete record of the evidence and administrative proceedings in the
appealed matter, including any prehearing and posthearing conferences
and hearing proceedings. This would provide OMHA with more discretion
to develop polices and uniform procedures for constructing the
administrative record, while preserving the role of the ALJ or attorney
adjudicator, as proposed in section II.B above, to identify the
evidence that was used in making the determinations below and the
evidence that was used in making his or her decision. We are proposing
at Sec. 423.2042(a)(1) to also adopt corresponding revisions to
indicate OMHA makes a complete record of the evidence and
administrative proceedings in the appealed matter in part 423, subpart
U proceedings.
Current Sec. 405.1042(a)(2) discusses which documents in the
record are marked as exhibits, and provides a non-exhaustive list of
documents that are marked to indicate that they were considered in
making the decisions under review or the ALJ's decision. It further
states that in the record, the ALJ also must discuss any evidence
excluded under Sec. 405.1028 and include a justification for excluding
the evidence. We are proposing to revise Sec. 405.1042(a)(2) to state
that the record would include marked as exhibits, the appealed
determinations, and documents and other evidence used in making the
appealed determinations and the ALJ's or attorney adjudicator's
decision, including, but not limited to, claims, medical records,
written statements, certificates, reports, affidavits, and any other
evidence the ALJ or attorney admits. We are proposing that attorney
adjudicators could mark exhibits because as proposed in section II.B,
attorney adjudicators would be adjudicating requests for hearing and
requests for review of a QIC dismissal, and should indicate the
portions of the record that he or she considered in making the decision
in the same manner as an ALJ. Proposed Sec. 405.1042(a)(2) would
continue to require certain evidence to be marked as exhibits, but
would clarify what would be marked, replacing ``the documents used in
making the decision under review,'' with ``the appealed determinations,
and documents and other evidence used in making the appealed
determinations and the ALJ's or attorney adjudicator's decision.'' We
believe this would clarify that the exhibited portion of the record
includes, at minimum, the appealed determinations, documents and other
evidence used in making the appealed determinations, and documents and
other evidence used in making the ALJ's or attorney adjudicator's
decision. The illustrative list of documents that may be marked as
exhibits pursuant to the rule in current Sec. 405.1042(a)(2) would be
incorporated in proposed Sec. 405.1042(a)(2) without change. We also
are proposing to clarify at Sec. 405.1042(a)(2) that the record would
include any evidence excluded or not considered by the ALJ or attorney
adjudicator, including, but not limited to, new evidence submitted by a
provider or supplier, or beneficiary represented by a provider or
supplier,
[[Page 43840]]
for which no good cause was established, and duplicative evidence
submitted by a party. All evidence presented should be included in the
record, even if excluded from consideration, in order to help ensure a
complete record of the evidence. However, such excluded evidence would
not be marked as an exhibit because the evidence was not considered in
making the ALJ's or attorney adjudicator's decision. We are proposing
at Sec. 423.2042(a)(2) to adopt corresponding revisions to clarify
what would be exhibited in part 423, subpart U proceedings, except the
reference to new evidence submitted by a provider or supplier, or
beneficiary represented by a provider or supplier, for which no good
cause was established as an example of evidence excluded or not
considered by the ALJ or attorney adjudicator, because there is no such
limitation on new evidence in part 423, subpart U proceedings.
As stated previously, current Sec. 405.1042(a)(2) includes
requirements to discuss any evidence excluded under current Sec.
405.1028 and include a justification for excluding the evidence. We are
proposing in Sec. 405.1042(a)(2) to remove these requirements. We
believe the requirement to justify excluding the evidence is not
necessary and is in tension with the requirement for a provider or
supplier, or beneficiary represented by a provider or supplier, to
establish good cause for submitting new evidence before it may be
considered. Section 1869(b)(3) of the Act establishes a general
prohibition on new evidence that must be overcome, and proposed Sec.
405.1028 would implement the statute by requiring the party to explain
why the evidence was not submitted prior to the QIC reconsideration,
and the ALJ or attorney adjudicator to make a finding of good cause to
admit the evidence. In place of the current Sec. 405.1042(a)(2)
requirement, as we discuss later, we are proposing at Sec.
405.1046(a)(2)(ii) to require that if new evidence is submitted for the
first time at the OMHA level and subject to a good cause determination
pursuant to proposed Sec. 405.1028, the new evidence and good cause
determination would be discussed in the decision. We believe the
decision is the appropriate place to discuss the new evidence and
document the good cause determination, and the discussion should focus
on the good cause determination required by proposed Sec. 405.1028,
regardless of whether good cause was found. We are not proposing any
corresponding changes to Sec. 423.2042 because there is no provision
equivalent to the current Sec. 405.1042(a)(2) requirement to discuss
any excluded evidence.
Current Sec. 405.1042(a)(3) provides that a party may review the
record ``at the hearing,'' or if a hearing is not held, at any time
before the ALJ's notice of decision is issued. However, this is rarely
done in practice. More often, a party requests a copy of the record
prior to the hearing, in accordance with current Sec. 405.1042(b). We
are proposing to revise Sec. 405.1042(a)(3) to state that a party may
request and review the record prior to or at the hearing, or if a
hearing is not held, at any time before the notice of decision is
issued. This revision would allow a party to request and review a copy
of the record ``prior to or at the hearing'' to more accurately reflect
the practices of parties. In addition, proposed Sec. 405.1042(a)(3)
would remove the reference to an ``ALJ's'' decision in explaining that
if a hearing is not held, a party may request and review the record at
any time before the notice of decision is issued, because in that
circumstance an ALJ or attorney adjudicator, as proposed in section
II.B, may issue the decision. We are proposing at Sec. 423.2042(a)(3)
to adopt corresponding revisions for part 423, subpart U proceedings.
Current Sec. 405.1042(a)(4) provides for the complete record,
including any recording of the hearing, to be forwarded to the Council
when a request for review is filed or the case is escalated to the
Council. However, in noting that the record includes recordings, only a
recording of the hearing is mentioned. We are proposing at Sec.
405.1042(a)(4) to add that the record includes recordings of prehearing
and posthearing conferences in addition to the hearing recordings, to
reinforce that recordings of conferences are part of the complete
record. We are proposing at Sec. 423.2042(a)(4) to adopt corresponding
revisions for part 423, subpart U proceedings.
Current Sec. 405.1042(b)(1) describes how a party may request and
receive copies of the record from the ALJ. However, after a case is
adjudicated, OMHA releases custody of the record and forwards it to a
CMS contractor or SSA, and the record may go on to the Council for
another administrative proceeding. This results in confusion for
parties when they request a copy of the record and OMHA is unable to
provide it. We are proposing at Sec. 405.1042(b)(1) that a party may
request and receive a copy of the record from OMHA while an appeal is
pending at OMHA. We also are proposing at Sec. 405.1042(b)(1) to
replace the reference to an ``exhibit list'' with a reference to ``any
index of the administrative record'' to provide greater flexibility in
developing a consistent structure for the administrative record. We
also are proposing to change the parallel reference to ``the exhibits
list'' in Sec. 405.1118 to ``any index of the administrative record.''
In addition, proposed Sec. 405.1042(b)(1) would replace the reference
to a ``tape'' of the oral proceeding with an ``audio recording'' of the
oral proceeding because tapes are no longer used and a more general
reference would accommodate future changes in recording formats. We
also are proposing to replace a parallel reference at Sec. 405.1118 to
a copy of the ``tape'' of the oral proceedings with a copy of the
``audio recording'' of the oral proceedings. We are proposing at
Sec. Sec. 423.2042(b)(1) and 423.2118 to adopt corresponding revisions
for part 423, subpart U proceedings, but note that current Sec.
423.2118 refers to a ``CD'' of the oral proceedings.
Current Sec. 405.1042(b)(2) provides that if a party requests all
or part of the record from an ALJ and an opportunity to comment on the
record, the time beginning with the ALJ's receipt of the request
through the expiration of the time granted for the party's response
does not count toward the 90 calendar day adjudication period. We are
proposing to revise Sec. 405.1042(b)(2) to state, if a party requests
a copy of all or part of the record from OMHA or the ALJ or attorney
adjudicator and an opportunity to comment on the record, any
adjudication period that applies in accordance with Sec. 405.1016 is
extended by the time beginning with the receipt of the request through
the expiration of the time granted for the party's response. This
proposed revision would clarify that a party may request a ``copy of''
all or part of the record, and would add that the request may be made
to OMHA, or the ALJ or attorney adjudicator, because a party may
request a copy of the record before it is assigned to an ALJ or
attorney adjudicator. In addition, proposed Sec. 405.1042(b)(2) would
revise the discussion of the effect of requesting an opportunity to
comment on the record on an adjudication period to remove the specific
reference to a 90 calendar day adjudication period, because in
accordance with proposed Sec. 405.1016, an adjudication period may be
90 or 180 calendar days, or alternatively may be waived by the
appellant and therefore not apply. We are proposing at Sec.
423.2042(b)(2) to adopt corresponding revisions for part 423, subpart U
proceedings.
Current Sec. 405.1042 does not address the circumstance in which a
party
[[Page 43841]]
requests a copy of the record but is not entitled to receive some of
the documents in the record. For example, when an appeal involves
multiple beneficiaries and one beneficiary requests a copy of the
record, the records related to other beneficiaries may not be released
to the requesting beneficiary unless he or she obtains consent from the
other beneficiaries to release the records that pertain to them.
Proposed Sec. 405.1042(b)(3) would address the possibility that a
party requesting a copy of the record is not entitled to receive the
entire record. Specifically, we are proposing in Sec. 405.1042(b)(3)
that if a party requests a copy of all or part of the record and the
record, including any audio recordings, contains information pertaining
to an individual that the requesting party is not entitled to receive
(for example, personally identifiable information or protected health
information), those portions of the record would not be furnished
unless the requesting party obtains consent from the individual. For
example, if a beneficiary requests a copy of the record for an appeal
involving multiple beneficiaries, the portions of the record pertaining
to the other beneficiaries would not be furnished to the requesting
beneficiary unless he or she obtains consent from the other
beneficiaries. We believe proposed Sec. 405.1042(b)(3) would help
ensure that parties are aware that they may not be entitled to receive
all portions of the record. We are proposing at Sec. 423.2042(b)(3) to
adopt corresponding revisions for part 423, subpart U proceedings.
We are inviting public comments on these proposals. If you choose
to comment on the proposals in this section, please include the caption
``The administrative record'' at the beginning of your comment.
u. Consolidated Proceedings (Sec. Sec. 405.1044 and 423.2044)
Current Sec. Sec. 405.1044 and 423.2044 explain that a
consolidated hearing may be held at the request of an appellant or on
the ALJ's own motion, if one or more of the issues to be considered at
the hearing are the same issues that are involved in another request
for hearing or hearings pending before the same ALJ, and CMS is
notified of an ALJ's intention to conduct a consolidated hearing. If a
consolidated hearing is conducted, current Sec. Sec. 405.1044 and
423.2044 further provide that the ALJ may make a consolidated decision
and record for the claims involved in the consolidated hearing, or may
make a separate decision and record for each claim involved in the
consolidated hearing. This authority is useful in allowing an ALJ and
the appellant to conduct a single proceeding on multiple appealed
claims or other determinations that are before the ALJ, reducing time
and expense for the appellant and the government to resolve the
appealed matter. However, the current provisions have caused confusion,
and have been limiting in circumstances in which no hearing is
conducted.
Current Sec. 405.1044 uses the terms ``requests for hearing,''
``cases,'' and ``claims'' interchangeably, which has resulted in
confusion because an appeal, or ``case,'' before an ALJ may involve
multiple requests for hearing, if an appellant's requests were combined
into one appeal for administrative efficiency prior to being assigned
to the ALJ. In addition, a request for hearing may involve one or more
claims. We are proposing in Sec. 405.1044 to use the term ``appeal''
to specify that appeals may be consolidated for hearing, and a single
decision and record may be made for consolidated appeals. We are
proposing to use ``appeal'' because an appeal is assigned a unique ALJ
appeal number, for which a unique decision and record is made. We also
are proposing to move current Sec. 405.1044(b) to new subsection
(a)(2), and to also replace the term ``combined'' with ``consolidated''
for consistent use in terminology. Further, we are proposing at Sec.
423.2044 to adopt corresponding revisions to use consistent terminology
in part 423, subpart U proceedings.
Current Sec. 405.1044(a) through (d) describes when a consolidated
hearing may be conducted, the effect on an adjudication period that
applies to the appeal, and providing notice of the consolidated hearing
to CMS. Proposed Sec. 405.1044(a) would incorporate current Sec.
405.1044(a) through (c) to combine the provisions related to a
consolidated hearing. In addition, proposed Sec. 405.1044(a)(4) would
replace the current requirement to notify CMS that a consolidated
hearing will be conducted in current Sec. 405.1044(d) with a
requirement to include notice of the consolidated hearing in the notice
of hearing issued in accordance with Sec. Sec. 405.1020 and 405.1022.
This would help ensure notice is provided to the parties and CMS, as
well as its contractors, in a consistent manner, and reduce
administrative burden on ALJs and their staff by combining that notice
into the existing notice of hearing. We are proposing at Sec.
423.2044(a) to adopt corresponding revisions for part 423, subpart U
proceedings.
Current Sec. 405.1044(e) explains that when a consolidated hearing
is conducted, the ALJ may consolidate the record and issue a
consolidated decision, or the ALJ may maintain separate records and
issue separate decisions on each claim. It also states that the ALJ
ensures that any evidence that is common to all claims and material to
the common issue to be decided is included in the consolidated record
or each individual record, as applicable. However, there has been
confusion on whether separate records may be maintained and a
consolidated decision can be issued, as well as what must be included
with the records when separate records are maintained. Proposed Sec.
405.1044(b) would incorporate some of current Sec. 405.1044(e) and add
provisions for making a consolidated record and decision. We are
proposing at Sec. 405.1044(b)(1) that if the ALJ decides to hold a
consolidated hearing, he or she may make either a consolidated decision
and record, or a separate decision and record on each appeal. This
proposed revision would maintain the current option to make a
consolidated record and decision, or maintain separate records and
issue separate decisions, but restructures the provision to highlight
that these are two mutually exclusive options. This proposal is
important because issuing a consolidated decision without also
consolidating the record, or issuing separate decisions when a record
has been consolidated, complicates effectuating a decision and further
reviews of the appeal(s). We are proposing in Sec. 405.1044(b)(2)
that, if a separate decision and record on each appeal is made, the ALJ
is responsible for making sure that any evidence that is common to all
appeals and material to the common issue to be decided, and audio
recordings of any conferences that were conducted and the consolidated
hearing are included in each individual administrative record. Proposed
Sec. 405.1044(b)(2) would address the confusion that sometimes results
in a copy of the audio recording of a consolidated hearing not being
included in the administrative records of each constituent appeal when
separate records are maintained, by clarifying that if a separate
decision and record is made, audio recordings of any conferences that
were conducted and the consolidated hearing are included in each
individual record. This proposal is important because the record for
each individual appeal must be complete. We are proposing at Sec.
423.2044(b)(1) and (b)(2) to adopt corresponding revisions for part
423, subpart U proceedings.
[[Page 43842]]
Current Sec. 405.1044 does not contemplate a consolidated record
and decision unless a consolidated hearing was conducted, which is
limiting when multiple appeals for an appellant can be consolidated in
a decision issued on the record without a hearing. We are proposing to
add Sec. 405.1044(b)(3), which would provide that, if a hearing would
not be conducted for multiple appeals that are before the same ALJ or
attorney adjudicator as proposed in section II.B, and the appeals
involve one or more of the same issues, the ALJ or attorney adjudicator
may make a consolidated decision and record at the request of the
appellant or on the ALJ's or attorney adjudicator's own motion. This
would provide authority for an ALJ or attorney adjudicator to make a
consolidated decision and record on the same basis that a consolidated
hearing may be conducted. We believe this authority would add
efficiency to the adjudication process when multiple appeals pending
before the same adjudicator can be decided without conducting a
hearing. We are proposing at Sec. 423.2044(b)(3) to adopt a
corresponding provision for part 423, subpart U proceedings.
Current Sec. 405.1044 also does not clearly address consolidating
hearings for multiple appellants, including situations in which a
beneficiary files a request for hearing on the same claim appealed by a
provider or supplier, and the provider or supplier has other pending
appeals that could be consolidated pursuant to current Sec. 405.1044.
The general practice is that a consolidated hearing is conducted for
the appeals of a single appellant. This is supported by the reference
to ``an'' appellant in current Sec. 405.1044(b), and helps ensure the
hearing and record is limited to protected information that the
appellant is authorized to receive. Therefore, we are proposing to add
Sec. 405.1044(c) to provide that consolidated proceedings may only be
conducted for appeals filed by the same appellant, unless multiple
appellants aggregated claims to meet the amount in controversy
requirement in accordance with Sec. 405.1006, and the beneficiaries
whose claims are at issue have all authorized disclosure of their
protected information to the other parties and any participants. This
would help ensure that beneficiary information is protected from
disclosure to parties who are not authorized to receive it, including
when a beneficiary requests a hearing for the same claim that has been
appealed by a provider or supplier, and appeals of other beneficiaries'
claims filed by the provider or supplier are also pending before the
same ALJ or attorney adjudicator. We are proposing at Sec. 423.2044(c)
to adopt a corresponding provision for part 423, subpart U proceedings.
We are inviting public comments on these proposals. If you choose
to comment on the proposals in this section, please include the caption
``Consolidated proceedings'' at the beginning of your comment.
v. Notice of Decision and Effect of an ALJ's or Attorney Adjudicator's
Decision (Sec. Sec. 405.1046, 405.1048, 423.2046, and 423.2048)
Current Sec. Sec. 405.1046 and 423.2046 describe the requirements
for a decision and providing notice of the decision, the content of the
notice, the limitation on a decision that addresses the amount of
payment for an item or a service, the timing of the decision, and
recommended decisions. Current Sec. Sec. 405.1048 and 423.2048
describe the effects of an ALJ's decision. However, the current
sections only apply to a decision on a request for hearing, leaving
ambiguities when issuing a decision on a request for review of a QIC or
IRE dismissal. We are proposing to consolidate the provisions of each
section that apply to a decision on a request for hearing under
proposed Sec. Sec. 405.1046(a), 405.1048(a), 423.2046(a) and
423.2048(a), with further revisions discussed below, and introduce new
Sec. Sec. 405.1046(b), 405.1048(b), 423.2046(b) and 423.2048(b) to
address a decision on a request for review of a QIC or IRE dismissal,
as well as to revise the titles and provisions of the sections to
expand their coverage to include decisions by attorney adjudicators, as
proposed in II.B above. We also are proposing to remove current Sec.
405.1046(d), which addresses the timing of a decision on a request for
hearing because it is redundant with Sec. 405.1016 and could lead to
confusion if a different adjudication period applies, such as a 180-
calendar day period for an escalated request for QIC reconsideration,
or if no adjudication period applies, such as when the period is waived
by the appellant. Similarly, we are proposing to remove current
Sec. Sec. 423.2046(a)(1) and (d) because the adjudication time frames
discussed in the provisions are redundant with provisions in proposed
Sec. 423.2016. In addition, we are proposing to re-designate current
Sec. Sec. 405.1046(e) and 423.2046(e), as proposed Sec. Sec.
405.1046(c) and 423.2046(c) respectively, to reflect the revised
structure of proposed Sec. Sec. 405.1046 and 423.2046.
Current Sec. 405.1046 states that an ALJ will issue a decision
unless a request for hearing is dismissed. We are proposing to revise
Sec. 405.1046(a) to state that an ALJ or attorney adjudicator would
issue a decision unless the request for hearing is dismissed or
remanded in order to accommodate those situations where the ALJ or
attorney adjudicator remands a case to the QIC. There has been
confusion regarding the content requirements of the decision itself, as
well as whether the findings or conclusions in a QIC reconsideration or
the arguments of the parties may be referenced or adopted in the
decision by reference. We believe that while the issues that are
addressed in a decision are guided by the reconsideration, as well as
the initial determination and redetermination, and a party may present
arguments in a framework that reflects recommended findings and
conclusions, the concept of a de novo review requires an ALJ or
attorney adjudicator to make independent findings and conclusions. To
address this confusion, we are proposing in Sec. 405.1046(a) to
require that the decision include independent findings and conclusions
to clarify that the ALJ or attorney adjudicator must make independent
findings and conclusions, and may not merely incorporate the findings
and conclusions offered by others, though the ALJ or attorney
adjudicator may ultimately make the same findings and conclusions. As
discussed in and for the reasons stated in section III.A.3.t above,
proposed Sec. 405.1046(a)(2)(ii) would also require that if new
evidence was submitted for the first time at the OMHA level and subject
to a good cause determination pursuant to proposed Sec. 405.1028, the
new evidence and good cause determination would be discussed in the
decision. We are proposing at Sec. 423.2046(a) to adopt corresponding
revisions for decisions on requests for hearing under part 423, subpart
U, except the proposals related to discussing new evidence and good
cause determinations related to new evidence because there are no
current requirements to establish good cause for submitting new
evidence in part 423, subpart U proceedings.
Current Sec. 405.1046(a) requires that a decision be mailed. As
OMHA transitions to a fully electronic case processing and adjudication
environment, new options for transmitting a decision to the parties and
CMS contractors may become available, such as through secure portals
for parties or through inter-system transfers for CMS contractors. We
are proposing in Sec. 405.1046(a) to revise the requirement that a
decision be mailed to
[[Page 43843]]
state that OMHA ``mails or otherwise transmits a copy of the
decision,'' to allow for additional options to transmit the decision as
technologies develop. We are proposing to revise Sec. 423.2046(a) to
adopt a corresponding revision for sending a decision under part 423,
subpart U.
Current Sec. 405.1046(a) also requires that a copy of the decision
be sent to the QIC that issued the reconsideration. However, if the
decision is issued pursuant to escalation of a request for a
reconsideration, no reconsideration was issued. To address this
circumstance, we are proposing in Sec. 405.1046(a) that the decision
would be issued to the QIC that issued the reconsideration or from
which the appeal was escalated. In addition, we are proposing in Sec.
405.1046(a) to replace ``reconsideration determination'' with
``reconsideration'' for consistency in referencing the QIC's action.
Current Sec. 405.1046(a) also requires that a copy of the decision be
sent to the contractor that made the initial determination. However,
this requirement adds to the administrative burden on OMHA and we
believe is unnecessary in light of the requirement that a copy of the
decision be sent to the QIC and the original decision is forwarded as
part of the administrative record to another CMS contractor to
effectuate the decision. Thus, we are proposing in Sec. 405.1046(a) to
remove the requirement to send a copy of the decision to the contractor
that issued the initial determination. In addition, we are proposing in
Sec. 423.2046(a) to replace ``reconsideration determination'' with
``reconsideration'' for consistency in referencing the IRE's action in
part 423, subpart U proceedings, but we are not proposing to
incorporate other changes proposed for Sec. 405.1046(a) in proposed
Sec. 423.2046(a) because: (1) escalation is not available in part 423,
subpart U proceedings; and (2) the Part D plan sponsor, which makes the
initial coverage determination, has an interest in receiving and
reviewing ALJ and attorney adjudicator decisions related to an
enrollee's appeal of drug coverage.
As discussed above, we are proposing to revise Sec. 405.1046(b) to
explain the process for making a decision on a request for review of a
QIC dismissal. In accordance with proposed Sec. 405.1004, we are
proposing in Sec. 405.1046(b)(1) that unless the ALJ or attorney
adjudicator dismisses the request for review of a QIC's dismissal or
the QIC's dismissal is vacated and remanded, the ALJ or attorney
adjudicator issues a written decision affirming the QIC's dismissal. We
are proposing in Sec. 405.1046(b)(1) that OMHA would mail or otherwise
transmit a copy of the decision to all the parties that received a copy
of the QIC's dismissal because we believe that the QIC would
appropriately identify the parties who have an interest in the
dismissal, and that notice of the decision on a request for review of a
QIC dismissal to any additional parties is unnecessary. We also believe
that notice to the QIC is not necessary when its dismissal is affirmed
because it has no further obligation to take action on the request for
reconsideration that it dismissed. We are proposing in Sec.
405.1046(b)(2)(i) that the decision affirming a QIC dismissal must
describe the specific reasons for the determination, including a
summary of the evidence considered and applicable authorities, but are
not proposing to require a summary of clinical or scientific evidence
because such evidence is not used in making a decision on a request for
a review of a QIC dismissal. In addition, we are proposing that Sec.
405.1046(b)(2)(ii) and (iii) would explain that the notice of decision
would describe the procedures for obtaining additional information
concerning the decision, and would provide notification that the
decision is binding and not subject to further review unless the
decision is reopened and revised by the ALJ or attorney adjudicator. We
are proposing to revise Sec. 423.2046(b) to adopt corresponding
provisions for a decision on requests for review of an IRE dismissal
under part 423, subpart U, except that the notice of decision will only
be sent to the enrollee because only the enrollee is a party.
We are proposing to revise the title of current Sec. 405.1048 to
read ``The effect of an ALJ's or attorney adjudicator's decision'' and
to replace the current introductory statement in Sec. 405.1048(a) that
``The decision of the ALJ is binding on all parties to the hearing''
with ``The decision of the ALJ or attorney adjudicator is binding on
all parties'' to make the subsection applicable to decisions by
attorney adjudicators and because the parties are parties to the
decision regardless of whether a hearing was conducted. We also are
proposing in Sec. 405.1048(b) that the decision of the ALJ or attorney
adjudicator on a request for review of a QIC dismissal is binding on
all parties unless the decision is reopened and revised by the ALJ or
attorney adjudicator under the procedures explained in Sec. 405.980.
We are proposing to revise Sec. 423.2048 to adopt corresponding
provisions for the effects of ALJ and attorney adjudicator decisions
under part 423, subpart U.
We are inviting public comments on these proposals. If you choose
to comment on the proposals in this section, please include the caption
``Notice of decision and effect of an ALJ's or attorney adjudicator's
decision'' at the beginning of your comment.
w. Removal of a Hearing Request From an ALJ to the Council (Sec. Sec.
405.1050 and 423.2050)
Current Sec. Sec. 405.1050 and 423.2050 explain the process for
the Council to assume responsibility for holding a hearing if a request
for hearing is pending before an ALJ. We are proposing to replace ``an
ALJ'' with ``OMHA'' in the section title, and to replace ``pending
before an ALJ'' with ``pending before OMHA,'' and ``the ALJ send'' with
``OMHA send'' in the section text. In accordance with section II.B
above, these proposed revisions would provide that a request for
hearing may be removed to the Council regardless of whether the request
is pending before an ALJ or an attorney adjudicator. We are not
proposing to replace the last instance of ``ALJ'' in the section text
because it refers specifically to hearings conducted by an ALJ.
We are inviting public comments on these proposals. If you choose
to comment on the proposals in this section, please include the caption
``Removal of a hearing request from an ALJ to the Council'' at the
beginning of your comment.
x. Dismissal of a Request for Hearing or Request for Review and Effect
of a Dismissal of a Request for Hearing or Request for Review
(Sec. Sec. 405.1052, 405.1054, 423.2052 and 423.2054)
Current Sec. Sec. 405.1052 and 423.2052 describe the circumstances
in which a request for hearing may be dismissed and the requirements
for a notice of dismissal, and current Sec. Sec. 405.1054 and 423.2054
describe the effect of a dismissal of a request for hearing. However,
both current sections apply to a dismissal of a request for hearing,
leaving ambiguities when issuing a dismissal of a request for review of
a QIC or IRE dismissal. We are proposing to maintain the provisions of
each section that apply to a dismissal of a request for hearing in
proposed Sec. Sec. 405.1052(a), 405.1054(a), 423.2052(a) and
423.2054(a), with further revisions discussed below, and to introduce
new Sec. Sec. 405.1052(b), 405.1054(b), 423.2052(b) and 423.2054(b) to
address a dismissal of a request for review of a QIC or IRE dismissal.
However, we are proposing to re-designate and revise Sec. Sec.
405.1052(a)(1) and 423.2052(a)(1), as discussed below, and re-designate
the remaining paragraphs in Sec. Sec. 405.1052(a) and 423.2052(a)
accordingly. We are also
[[Page 43844]]
proposing to remove the introductory language to current Sec. Sec.
405.1052 and 423.2052 because it is unnecessary to state that a
dismissal of a request for hearing is in accordance with the provisions
of the section, as the provisions are themselves binding authority and
state in full when a request for hearing may be dismissed. In addition,
we are proposing to revise the titles of the sections to expand their
coverage to include dismissals of requests to review a QIC or IRE
dismissal. Furthermore, we are proposing to re-designate and revise
current Sec. Sec. 405.1052(b) and 423.2052(b), which describe notices
of dismissal, as proposed Sec. Sec. 405.1052(d) and 423.2052(d)
respectively, to reflect the revised structure of proposed Sec. Sec.
405.1052 and 423.2052. We also are proposing to remove current Sec.
423.2052(a)(8) and (c) because current Sec. 423.2052(a)(8) restates
current Sec. 423.1972(c)(1), which already provides that a request for
hearing will be dismissed if the request itself shows that the amount
in controversy is not met, and current Sec. 423.2052(c) restates
current Sec. 423.1972(c)(2), which already provides that if after a
hearing is initiated, the ALJ finds that the amount in controversy is
not met, the ALJ discontinues the hearing and does not rule on the
substantive issues raised in the appeal. We note that a dismissal would
be warranted in these circumstances pursuant to current Sec.
423.2052(a)(3), which is carried over as proposed Sec. 423.2052(a)(2)
because the enrollee does not have a right to a hearing if the amount
in controversy is not met.
We are proposing to re-designate and revise current Sec. Sec.
405.1052(a)(1) and 423.2052(a)(1) as proposed Sec. Sec. 405.1052(c)
and 423.2052(c) to separately address dismissals based on a party's
withdrawal. We are proposing in Sec. Sec. 405.1052(c) and 423.2052(c)
to include withdrawals of requests to review a QIC dismissal because we
also propose to add provisions to address other dismissals of those
requests at Sec. Sec. 405.1052(b) and 423.2052(b). We also are
proposing that an ALJ or attorney adjudicator may dismiss a request for
review of a QIC dismissal based on a party's withdrawal of his or her
request because as proposed in section II.B above, both ALJs and
attorney adjudicators would be able to adjudicate requests to review a
QIC dismissal. In addition, we are proposing that an ALJ or attorney
adjudicator may dismiss a request for hearing based on a party's
withdrawal of his or her request. As discussed in section II.B above,
we believe that well-trained attorneys can efficiently perform a review
of these requests and issue dismissals. We believe using attorney
adjudicators to the maximum extent possible would help OMHA be more
responsive to appellants and allow ALJs to focus on conducting hearings
and issuing decisions. We also are proposing to revise the language in
current Sec. Sec. 405.1052(a)(1) and 423.2052(a)(1) (as redesignated
in proposed Sec. Sec. 405.1052(c) and 423.2052(c)) to (1) replace
``notice of the hearing decision'' with ``notice of the decision,
dismissal or remand'' to reflect that a decision may be issued without
a hearing, and to reflect other possible outcomes of the proceeding
(dismissal and remand), and (2) to clarify that a request to withdraw a
request for hearing may be made orally at a hearing before the ALJ
because only an ALJ may conduct a hearing.
Current Sec. 405.1052(a)(2) describes three possible alternatives
for dismissing a request for hearing when the party that requested the
hearing, or the party's representative, does not appear at the time and
place set for the hearing. The current alternatives have caused
confusion for appellants in understanding whether they are required to
submit a statement explaining a failure to appear. Further, current
provisions do not require evidence in the record to document an
appellant was aware of the time and place of the hearing, and this has
resulted in remands from the Council. We are proposing to simplify the
provision to provide two alternatives, and to require that contact has
been made with an appellant and documented, or an opportunity to
provide an explanation for failing to appear has been provided before a
request for hearing is dismissed for failing to appear at the hearing.
We are proposing at Sec. 405.1052(a)(1)(i) to set forth the first
alternative which would provide that a request for hearing may be
dismissed if the party that filed the request was notified before the
time set for hearing that the request for hearing might be dismissed
for failure to appear, the record contains documentation that the party
acknowledged the notice of hearing, and the party does not contact the
ALJ within 10 calendar days after the hearing or does contact the ALJ
but does not provide good cause for not appearing. We are proposing at
Sec. 405.1052(a)(1)(ii) to set forth the second alternative which
would provide that a request for hearing may be dismissed if the record
does not contain documentation that the party acknowledged the notice
of hearing, but the ALJ sends a notice to the party at his or her last
known address asking why the party did not appear, and the party does
not respond to the ALJ's notice within 10 calendar days after receiving
the notice or does respond but does not provide good cause for not
appearing. In either circumstance, we are maintaining in proposed Sec.
405.1052(a)(1) the current standard that in determining whether good
cause exists, the ALJ considers any physical, mental, educational, or
linguistic limitations that the party may have identified. We believe
proposed Sec. 405.1052(a)(1) would help ensure that appellants have
consistent notice of a possible dismissal for failure to appear and an
opportunity to provide a statement explaining why they did not appear
before a dismissal is issued. We are proposing to revise Sec.
423.2052(a)(1) to adopt corresponding revisions for dismissing a
request for hearing under part 423, subpart U.
Current OMHA policy provides that a request for hearing that does
not meet the requirements of current Sec. 405.1014 may be dismissed by
an ALJ after an opportunity is provided to the appellant to cure an
identified defect (OMHA Case Processing Manual, division 2, chapter 3,
section II-3-6 D and E). A dismissal is appropriate because as an
administrative matter, the proceedings on the request do not begin
until the information necessary to adjudicate the request is provided
and the appellant sends a copy of the request to the other parties.
Additionally, a request cannot remain pending indefinitely once an
appellant has demonstrated that he or she is unwilling to provide the
necessary information or to send a copy of the request to the other
parties. Therefore, we are proposing at Sec. 405.1052(a)(7) to explain
that a request for hearing may be dismissed if the request is not
complete in accordance with proposed Sec. 405.1014(a)(1) or the
appellant did not send copies of its request to the other parties in
accordance with proposed Sec. 405.1014(d), after the appellant is
provided with an opportunity to complete the request and/or send copies
of the request to the other parties. We believe adding this provision
would emphasize the importance of following the requirements for filing
a request for hearing, and clarify the outcome if the requirements are
not met and the appellant does not cure identified defects after being
provided with an opportunity to do so. We are proposing at Sec.
423.2052(a)(7) to adopt a corresponding provision for dismissing a
request for hearing under part 423, subpart U.
[[Page 43845]]
As discussed above, we are proposing to add Sec. 405.1052(b) to
explain when a request for review of a QIC dismissal would be
dismissed. Under proposed Sec. 405.1052(b), a request for review could
be dismissed in the following circumstances: (1) the person or entity
requesting the review has no right to the review of the QIC dismissal
under proposed Sec. 405.1004; (2) the party did not request a review
within the stated time period and the ALJ or attorney adjudicator has
not found good cause for extending the deadline; (3) a beneficiary or
beneficiary's representative filed the request for review and the
beneficiary passed away while the request for review is pending and all
of the following criteria apply: (i) a surviving spouse or estate has
no remaining financial interest in the case, (ii) no other individuals
or entities have a financial interests in the case and wish to pursue
an appeal, and (iii) no other individual or entity filed a valid and
timely request for a review of the QIC dismissal; and (4) the
appellant's request for review is not complete in accordance with
proposed Sec. 405.1014(a)(1) or the appellant does not send a copy of
the request to the other parties in accordance with proposed Sec.
405.1014(d), after being provided with an opportunity to complete the
request and/or send a copy of the request to the other parties. We
believe these provisions would encompass the reasons for dismissing a
request for a review of a QIC dismissal, and are necessarily
differentiated from dismissing a request for hearing because, as
explained in section III.A.3.c above, we do not believe there is a
right to a hearing for requests for a review of a QIC dismissal. We are
proposing at Sec. 423.2052(b) to adopt corresponding provisions for
dismissing requests for a review of an IRE dismissal under part 423,
subpart U proceedings.
As discussed above, current Sec. 405.1052(b) describes the
requirements for providing notice of the dismissal and we are proposing
to re-designate the paragraph as proposed Sec. 405.1052(d). For the
same reasons discussed in section III.A.3.v above for allowing a notice
of a decision to be provided by means other than mail, we are proposing
in Sec. 405.1052(d) that OMHA may mail or ``otherwise transmit''
notice of a dismissal. We are proposing to revise Sec. 423.2052(d) to
adopt a corresponding revision for notices of dismissal under part 423,
subpart U.
Current Sec. 405.1052(b) requires notice of the dismissal to be
sent to all parties at their last known address. However, we believe
that requirement is overly inclusive and causes confusion by requiring
notice of a dismissal to be sent to parties who have not received a
copy of the request for hearing or request for review that is being
dismissed. Thus, we are proposing to revise Sec. 405.1052(d) to state
that the notice of dismissal is sent to the parties who received a copy
of the request for hearing or request for review because only those
parties are on notice that a request was pending. In addition, we are
proposing at Sec. 405.1052(d) that if a party's request for hearing or
request for review is dismissed, the appeal would proceed with respect
to any other parties who also filed a valid request for hearing or
review regarding the same claim or disputed matter. This would address
the rare circumstance in which more than one party submits a request,
but the request of one party is dismissed. In that circumstance, the
appeal proceeds on the request that was not dismissed, and the party
whose request was dismissed remains a party to the proceedings but does
not have any rights associated with a party that filed a request, such
as the right to escalate a request for hearing. We are not proposing a
corresponding revision to Sec. 423.2052(c) because only the enrollee
is a party to an appeal under part 423, subpart U.
Current Sec. 405.1052 does not include authority for an ALJ to
vacate his or her own dismissal, and instead requires an appellant to
request the Council review an ALJ's dismissal. As explained in the 2005
Interim Final Rule (70 FR 11465), the authority for an ALJ to vacate
his or her own dismissal was not regarded as an effective remedy
because the record was no longer in the ALJ hearing office, and the
resolution was complicated when appellants simultaneously asked the ALJ
to vacate the dismissal order and asked the Council to review the
dismissal. However, in practice, the lack of the authority for an ALJ
to vacate his or her own dismissal has constrained ALJs' ability to
correct erroneous dismissals that can be easily remedied by the ALJ,
and has caused unnecessary work for the Council. We are proposing to
add Sec. 405.1052(e) to provide the authority for an ALJ or an
attorney adjudicator, as proposed in section II.B above, to vacate his
or her own dismissal within 6 months of the date of the notice of
dismissal, in the same manner as a QIC can vacate its own dismissal. We
believe that this authority would reduce unnecessary appeals to the
Council and provide a more timely resolution of dismissals for
appellants, whether the dismissal was issued by an ALJ or attorney
adjudicator. We also note that the coordination for obtaining the
administrative record and addressing instances in which an appellant
also requests a review of the dismissal by the Council can be addressed
through operational coordination among CMS, OMHA, and the DAB. We are
proposing in Sec. 423.2052(e) to adopt a corresponding provision for
vacating a dismissal under part 423, subpart U.
To align the effects of a dismissal with proposed Sec.
405.1052(e), we are proposing to add Sec. 405.1054(a) to state that
the dismissal of a request for hearing is binding unless it is vacated
by the ALJ or attorney adjudicator under Sec. 405.1052(e), in addition
to the current provision that allows the dismissal to be vacated by the
Council under Sec. 405.1108(b). To explain the effect of a dismissal
of a request for review of a QIC dismissal, consistent with Sec.
405.1004, we are proposing in Sec. 405.1054(b) to provide that the
dismissal of a request for review of a QIC dismissal of a request for
reconsideration is binding and not subject to further review unless it
is vacated by the ALJ or attorney adjudicator under Sec. 405.1052(e).
We are proposing in Sec. 423.2054 to adopt corresponding revisions for
the effect of dismissals of request for hearing and requests for review
of an IRE dismissal under part 423, subpart U.
We are inviting public comments on these proposals. If you choose
to comment on the proposals in this section, please include the caption
``Dismissal of a request for hearing or request for review and effect
of a dismissal of a request for hearing or request for review'' at the
beginning of your comment.
4. Applicability of Medicare Coverage Policies (Sec. Sec. 405.1060,
405.1062, 405.1063, 423.2062, 423.2063)
Current Sec. 405.1060 addresses the applicability of national
coverage determinations (NCDs) to claim appeals brought under part 405,
subpart I and provides that an ALJ and the Council may not disregard,
set aside, or otherwise review an NCD, but may review the facts of a
particular case to determine whether an NCD applies to a specific claim
for benefits and, if so, whether the NCD was applied correctly to the
claim. Current Sec. 405.1062 addresses the applicability of local
coverage determinations (LCDs) and other policies, and specifies that
ALJs and the Council are not bound by LCDs, local medical review
policies (LMRPs), or CMS program guidance, such as program memoranda
and manual instructions, but will give substantial deference to these
policies if they are
[[Page 43846]]
applicable to a particular case, and if an ALJ or the Council declines
to follow a policy in a particular case, the ALJ or the Council must
explain the reasons why the policy was not followed. Similarly, current
Sec. 423.2062 states that ALJs and the Council are not bound by CMS
program guidance but will give substantial deference to these policies
if they are applicable to a particular case, and if an ALJ or the
Council declines to follow a policy in a particular case, the ALJ or
the Council must explain the reasons why the policy was not followed.
Current Sec. Sec. 405.1062 and 423.2062 also provide that an ALJ or
Council decision to disregard a policy applies only to the specific
claim being considered and does not have precedential effect. Further,
Sec. 405.1062 states that an ALJ or the Council may not set aside or
review the validity of an LMRP or LCD for purposes of a claim appeal.
Current Sec. Sec. 405.1063 and 423.2063 address the applicability of
laws, regulations, and CMS Rulings, and provide that all laws and
regulations pertaining to the Medicare program (and for Sec. 405.1063
the Medicaid program as well), including but not limited to Titles XI,
XVIII, and XIX of the Act and applicable implementing regulations, are
binding on ALJs and the Council, and consistent with Sec. 401.108, CMS
Rulings are binding on all HHS components that adjudicate matters under
the jurisdiction of CMS.
We are proposing to revise Sec. Sec. 405.1060, 405.1062, 405.1063,
423.2062, and 405.2063 to replace ``ALJ'' or ``ALJs'' with ``ALJ or
attorney adjudicator'' or ``ALJs or attorney adjudicators'' except in
the second sentence of Sec. 405.1062(c). As proposed in section II.B
above, an attorney adjudicator would issue certain decisions and
dismissals and therefore would apply the authorities addressed by these
sections. Requiring the attorney adjudicators to apply the authorities
in the same manner as an ALJ would provide consistency in the
adjudication process, regardless of who is assigned to adjudicate a
request for an ALJ hearing or request for review of a QIC or IRE
dismissal. We are not proposing to revise the second sentence in
current Sec. 405.1062(c) because attorney adjudicators would not
review or set aside an LCD (or any part of an LMRP that constitutes an
LCD) in accordance with part 426 (part 426 appeals are currently heard
by ALJs in the Civil Remedies Division of the DAB).
We are inviting public comments on these proposals. If you choose
to comment on the proposals in this section, please include the caption
``Applicability of Medicare Coverage Policies'' at the beginning of
your comment.
5. Council Review and Judicial Review
a. Council Review: General (Sec. Sec. 405.1100, 423.1974 and 423.2100)
Current Sec. 405.1100 discusses the Council review process.
Current Sec. 405.1100(a) states that the appellant or any other party
to the hearing may request that the Council review an ALJ's decision or
dismissal. We are proposing to revise Sec. 405.1100(a) to replace
``the hearing'' with ``an ALJ's or attorney adjudicator's decision or
dismissal,'' and ``an ALJ's decision or dismissal,'' with ``the ALJ's
or attorney adjudicator's decision or dismissal'' because the parties
are parties to the proceedings and the resulting decision or dismissal
regardless of whether a hearing is conducted, and as proposed in
section II.B above, an attorney adjudicator would be able to issue
certain decisions or dismissals for which Council review maybe
requested.
Current Sec. 423.1974 states that an enrollee who is dissatisfied
with an ALJ hearing decision may request that the Council review the
ALJ's decision or dismissal as provided in Sec. 423.2102, and current
Sec. 423.2100(a) states that consistent with Sec. 423.1974, the
enrollee may request that the Council review an ALJ's decision or
dismissal. We are proposing to revise Sec. 423.1974 to replace ``ALJ
hearing decision'' with ``an ALJ's or attorney adjudicator's decision
or dismissal,'' and to revise Sec. Sec. 423.1974 and 423.2100(a) to
replace ``ALJ's decision or dismissal'' with ``an ALJ's or attorney
adjudicator's decision or dismissal'' because the parties are parties
to the proceedings and resulting decision or dismissal regardless of
whether a hearing is conducted, and as proposed in section II.B above,
an attorney adjudicator may issue a decision or dismissal for which
Council review maybe requested.
Current Sec. 405.1100(b) provides that under the circumstances set
forth in Sec. Sec. 405.1104 and 405.1108, an appellant may request
escalation of a case to the Council for a decision even if the ALJ has
not issued a decision or dismissal in his or her case. We are proposing
to revise Sec. 405.1100(b) to provide that under circumstances set
forth in Sec. Sec. 405.1016 and 405.1108, the appellant may request
that a case be escalated to the Council for a decision even if the ALJ
or attorney adjudicator has not issued a decision, dismissal, or remand
in his or her case. These revisions would reference Sec. 405.1016,
which, as discussed in section III.A.3.h above, would replace the
current Sec. 405.1104 provisions for escalating a case from the OMHA
level to the Council. They would also provide that in addition to
potentially issuing a decision or dismissal, an ALJ or attorney
adjudicator, as proposed in section II.B above, may issue a remand--
this would present a complete list of the actions that an ALJ or
attorney adjudicator could take on an appeal.
Current Sec. Sec. 405.1100(c) and 423.2100(b) and (c) state in
part that when the Council reviews an ALJ's decision, it undertakes a
de novo review, and the Council issues a final decision or dismissal
order or remands a case to the ALJ. We are proposing to revise
Sec. Sec. 405.1100(c) and 423.2100(b) and (c) to state that when the
Council reviews an ALJ's or attorney adjudicator's decision, it
undertakes a de novo review and may remand a case to an ALJ or attorney
adjudicator, so that the same standard for review is applied to ALJ and
attorney adjudicator decisions. We are also proposing to revise
Sec. Sec. 405.1100(c) and 423.2100(c) to state that the Council may
remand an attorney adjudicator's decision to the attorney adjudicator
so that like an ALJ, the attorney adjudicator can take the appropriate
action ordered by the Council (however, if the Council were to order
that a hearing must be conducted, the case would be transferred to an
ALJ upon remand to the attorney adjudicator because only an ALJ may
conduct a hearing).
Current Sec. 423.2100(c) and (d) provide that the Council issues a
final decision, dismissal order, or remand no later than the period of
time specified in the respective paragraph, beginning on the date that
the request for review is received by the entity specified in the ALJ's
written notice of decision. We are proposing to revise Sec.
423.2100(c) and (d) to state that the period of time begins on the date
that the request for review is received by the entity specified in the
ALJ's or attorney adjudicator's written notice of decision because an
attorney adjudicator may also issue a decision, as proposed in section
II.B above. We are also proposing to revise Sec. 423.2100(c) to
correct a typographical error by inserting ``day'' into the current
``90 calendar period,'' so it is clear to enrollees that the period of
time being referenced is the 90 calendar day period.
Current Sec. 405.1100(d) states in part that when deciding an
appeal that was escalated from the ALJ level to the Council, the
Council will issue a final decision or dismissal order or remand order
within 180 calendar days of receipt of the appellant's request for
escalation. A remand from the Council
[[Page 43847]]
after an appeal is escalated to it is exceedingly rare and done in
circumstances in which the Council must remand to an ALJ so that the
ALJ may obtain information under current Sec. 405.1034 that is missing
from the written record and essential to resolving the issues on
appeal, and that information can only be provided by CMS or its
contractors, because the Council does not have independent authority to
obtain the information from CMS or its contractors. In addition, an
appeal may have not yet have been assigned to an ALJ, or could be
assigned to an attorney adjudicator as proposed in section II.B above,
when the appeal was escalated by the appellant. We are proposing to
revise Sec. 405.1100(d) to state that if the Council remands an
escalated appeal, the remand is to the OMHA Chief ALJ because the rare
and unique circumstances in which an escalated appeal is remanded by
the Council require immediate attention that the OMHA Chief ALJ is
positioned to provide to minimize delay for the appellant, and to
minimize confusion if the case was not assigned to an ALJ or attorney
adjudicator when it was escalated.
We are inviting public comments on these proposals. If you choose
to comment on the proposals in this section, please include the caption
``Medicare Appeals Council review: general'' at the beginning of your
comment.
b. Request for Council Review When the ALJ Issues Decision or Dismissal
(Sec. Sec. 405.1102 and 423.2102)
Current Sec. Sec. 405.1102 and 423.2102 discuss requests for
Council review when an ALJ issues a decision or dismissal. Current
Sec. Sec. 405.1102(a)(1) and 423.2102(a)(1) provide that a party or
enrollee, respectively, to ``the ALJ hearing'' may request a Council
review if the party or enrollee files a written request for a Council
review within 60 calendar days after receipt of the ALJ's decision or
dismissal, which is in accordance with the criteria specified in
current Sec. Sec. 405.1102 and 423.2102. However, a party or enrollee
is a party to the proceedings and resulting decision or dismissal, and
may appeal the decision or dismissal regardless of whether a hearing
was conducted in the appeal, and as proposed in section II.B above, an
attorney adjudicator may issue a decision or dismissal for which
Council review may be requested. To help ensure there is no confusion
that a party or enrollee may seek Council review even if a hearing
before an ALJ is not conducted or if an attorney adjudicator issues the
decision or dismissal, we are proposing to revise Sec. Sec.
405.1102(a)(1) and 423.2102(a)(1) to state a party or enrollee to a
decision or dismissal issued by an ALJ or attorney adjudicator may
request Council review if the party or enrollee files a written request
for a Council review within 60 calendar days after receipt of the ALJ's
or attorney adjudicator's decision or dismissal.
Current Sec. Sec. 405.1102(c) and 423.2102(c) provide that a party
or enrollee, respectively, does not have a right to seek Council review
of an ALJ's remand to a QIC or IRE, or an ALJ's affirmation of a QIC's
or IRE's dismissal of a request for reconsideration. However, under
current Sec. Sec. 405.1004(c) and 423.2004(c), a party or enrollee,
respectively, may currently seek Council review of a dismissal of a
request for review of a QIC or IRE dismissal because, as discussed in
section III.A.3.x above, an ALJ does not currently have the authority
to vacate his or her own dismissal. As proposed in section II.B above,
an attorney adjudicator could adjudicate requests for a review of a QIC
or IRE dismissal. In addition, proposed Sec. Sec. 405.1052(e) and
423.2052(e) would establish the authority for an ALJ or attorney
adjudicator to vacate his or her own dismissal, and in accordance with
the policy that a review of a dismissal is only reviewable at the next
level of appeal, as discussed in section III.A.3.c above, proposed
Sec. Sec. 405.1102(c) and 423.2102(c) would be revised to indicate
that a party does not have the right to seek Council review of an ALJ's
or attorney adjudicator's dismissal of a request for review of a QIC
dismissal. Therefore, we are proposing at Sec. Sec. 405.1102(c) and
423.2102(c) to add that a party does not have the right to seek Council
review of an ALJ's or attorney adjudicator's remand to a QIC or IRE,
affirmation of a QIC's or IRE's dismissal of a request for
reconsideration, or dismissal of a request for review of a QIC or IRE
dismissal.
We are inviting public comments on these proposals. If you choose
to comment on the proposals in this section, please include the caption
``Request for Council review when ALJ issues decision or dismissal'' at
the beginning of your comment.
c. Where a Request for Review or Escalation May Be Filed (Sec. Sec.
405.1106 and 423.2106)
Current Sec. Sec. 405.1106(a) and 423.2106 provide that when a
request for a Council review is filed after an ALJ has issued a
decision or dismissal, the request for review must be filed with the
entity specified in the notice of the ALJ's action, and under Sec.
405.1106, the appellant must also send a copy of the request for review
to the other parties to the ALJ decision or dismissal who received a
copy of the hearing decision or notice of dismissal. The sections also
explain that if the request for review is timely filed with an entity
other than the entity specified in the notice of the ALJ's action, the
Council's adjudication period to conduct a review begins on the date
the request for review is received by the entity specified in the
notice of the ALJ's action, and upon receipt of a request for review
from an entity other than the entity specified in the notice of the
ALJ's action, the Council sends written notice to the appellant of the
date of receipt of the request and commencement of the adjudication
time frame. In addition, current Sec. 405.1106(b) discusses that if an
appellant files a request to escalate an appeal to the Council because
the ALJ has not completed his or her action on the request for hearing
within the adjudication deadline under Sec. 405.1016, the request for
escalation must be filed with both the ALJ and the Council, and the
appellant must also send a copy of the request for escalation to the
other parties and failure to copy the other parties tolls the Council's
adjudication deadline set forth in Sec. 405.1100 until all parties to
the hearing receive notice of the request for Council review.
We are proposing in Sec. Sec. 405.1106 and 423.2106 to replace all
instances of ``ALJ'' with ``ALJ or attorney adjudicator,'' ``ALJ's
action'' with ``ALJ's or attorney adjudicator's action,'' to provide
that the sections apply to decisions and dismissals issued by an
attorney adjudicator as well, as proposed in section II.B, and
therefore appellants would have the same right to seek Council review
of the attorney adjudicator's decision or dismissal, and the Council
would have the authority to take the same actions in reviewing an
attorney adjudicator's decision or dismissal. We are also proposing to
replace ``a copy of the hearing decision under Sec. 405.1046(a) or a
copy of the notice of dismissal under Sec. 405.1052(b)'' in Sec.
405.1106(a) with ``notice of the decision or dismissal,'' because
Sec. Sec. 405.1046 and 405.1052 provide for notice of a decision or
dismissal, respectively, to be sent, and a decision or dismissal may be
issued by an ALJ or attorney adjudicator without conducting a hearing.
In addition, in describing the consequences of failing to send a copy
of the request for review to the other parties, we are proposing to
replace ``until all parties to the hearing'' in
[[Page 43848]]
Sec. 405.1106(a) to ``until all parties to the ALJ or attorney
adjudicator decision or dismissal,'' to align the language with the
preceding sentences.
We are proposing to revise Sec. 405.1106(b) to align the paragraph
with the revised escalation process proposed at Sec. 405.1016 (see
section III.A.3.h.i above). Specifically, we are proposing to revise
Sec. 405.1106(b) to state that if an appellant files a request to
escalate an appeal to the Council level because the ALJ or attorney
adjudicator has not completed his or her action on the request for
hearing within an applicable adjudication period under Sec. 405.1016,
the request for escalation must be filed with OMHA and the appellant
must also send a copy of the request for escalation to the other
parties who were sent a copy of the QIC reconsideration. This proposed
revision would align this section with the revised process in proposed
Sec. 405.1016 by specifying that the request for escalation is filed
with OMHA and removing the requirement for an appellant to also file
the request with the Council. In addition, proposed Sec. 405.1106(b)
would specify that the request for escalation must be sent to the other
parties who were sent a copy of the QIC reconsideration, which would
align with the parties to whom the appellant is required to send a copy
of its request for hearing. Proposed Sec. 405.1106(b) would also refer
to ``an applicable adjudication period'' under Sec. 405.1016, to align
the terminology and because an adjudication period may not apply to a
specific case (for example, if the appellant waived an applicable
adjudication time frame). Finally, proposed Sec. 405.1106(b) would
provide that failing to copy the other parties would toll the Council's
adjudication deadline until all parties who were sent a copy of the QIC
reconsideration receive notice of the request for escalation, rather
than notice of the request for Council review as is currently required,
because the revised escalation process proposed at Sec. 405.1016 would
remove the requirement to file a request for Council review when
escalation is requested from the OMHA to the Council level.
We are inviting public comments on these proposals. If you choose
to comment on the proposals in this section, please include the caption
``Where a request for review or escalation may be filed'' at the
beginning of your comment.
d. Council Actions When Request for Review or Escalation Is Filed
(Sec. Sec. 405.1108 and 423.2108)
Current Sec. Sec. 405.1108 and 423.2108 describe the actions the
Council may take upon receipt of a request for review or, for Sec.
405.1108, a request for escalation. We are proposing at Sec.
405.1108(d) introductory text to replace ``ALJ level'' with ``OMHA
level'' to provide that the Council's actions with respect to a request
for escalation are the same regardless of whether the case was pending
before an ALJ or attorney adjudicator, or unassigned at the time of
escalation. We are also proposing at Sec. 405.1108(d)(3) to replace
``remand to an ALJ for further proceedings, including a hearing'' with
``remand to OMHA for further proceedings, including a hearing'' because
we believe the Council could remand an escalated case to an ALJ or
attorney adjudicator for further proceedings, but if the Council
ordered that a hearing be conducted, the case would need to be remanded
to an ALJ. We are not proposing any corresponding changes to Sec.
423.2108 because escalation is not available for Part D coverage
appeals.
We are also proposing in Sec. Sec. 405.1108(b) and 423.2108(b), to
provide that the dismissal for which Council review may be requested is
a dismissal of a request for a hearing, because as discussed in section
III.A.3.x above, proposed Sec. Sec. 405.1054(b) and 423.2054(b) would
provide that a dismissal of a request for a review of a QIC or IRE
dismissal of a request for reconsideration is binding and not subject
to further review. Finally, we are proposing to replace all remaining
references in Sec. Sec. 405.1108 and 423.2108 to ``ALJ'' with ``ALJ or
attorney adjudicator'' and ``ALJ's'' with ``ALJ's or attorney
adjudicator's'' to further provide that the Council's actions with
respect to a request for review or escalation are the same for cases
that were decided by or pending before an ALJ or an attorney
adjudicator.
We are inviting public comments on these proposals. If you choose
to comment on the proposals in this section, please include the caption
``Council actions when request for review or escalation is filed'' at
the beginning of your comment.
e. Council Reviews on Its Own Motion (Sec. Sec. 405.1110 and 423.2110)
Current Sec. Sec. 405.1110 and 423.2110 discuss Council reviews on
its own motion. Current Sec. Sec. 405.1110(a) and 423.2110(a) state
the general rule that the Council may decide on its own motion to
review a decision or dismissal issued by an ALJ, and CMS or its
contractor, including the IRE, may refer a case to the Council within
60 calendar days after the date of the ALJ's decision or dismissal (for
Sec. 405.1110(a)) or after the ALJ's written decision or dismissal is
issued (for Sec. 423.2110(a)). Current Sec. Sec. 405.1110(b) and
423.2110(b) provide the standards for CMS or its contractors to refer
ALJ decisions and dismissals to the Council for potential review under
the Council's authority to review ALJ decisions and dismissals on the
Council's own motion, and require that a copy of a referral to the
Council be sent to the ALJ whose decision or dismissal was referred,
among others. Current Sec. Sec. 405.1110(c) and 423.2110(c) explain
the standards of review used by the Council in reviewing the ALJ's
action. Current Sec. Sec. 405.1110(d) and 423.2110(d) explain the
actions the Council may take, including remanding the case to the ALJ
for further proceedings, and state that if the Council does not act on
a referral within 90 calendar days after receipt of the referral
(unless the 90 calendar day period has been extended as provided in the
respective subpart), the ALJ's decision or dismissal is binding (Sec.
405.1110(d) further specifies that the decision or dismissal is binding
on the parties to the decision).
We are proposing at Sec. Sec. 405.1110 and 423.2110 to replace
each instance of ``at the ALJ level'' with ``at the OMHA level'' and
``ALJ proceedings'' with ``OMHA proceedings''. We believe the standards
for referral to the Council by CMS or its contractor would be the same
regardless of whether the case was decided by an ALJ or an attorney
adjudicator, and that ``at the OMHA level'' and ``OMHA proceedings''
would reduce confusion in situations where the case was decided by an
attorney adjudicator. We are proposing at Sec. 405.1110(b)(2) to
replace the references to current Sec. 405.1052(b) with references to
Sec. 405.1052(d) to reflect the structure of proposed Sec. 405.1052,
and are also proposing to revise Sec. Sec. 405.1110(b)(2) and
423.2110(b)(2)(ii) to state that CMS (in Sec. 405.1110(b)(2)) or CMS
or the IRE (in Sec. 423.2110(b)(2)(ii)) sends a copy of its referral
to the OMHA Chief ALJ. The current requirement to send a copy of the
referral to the ALJ is helpful in allowing OMHA ALJs to review the
positions that CMS is advocating before the Council, but at times has
caused confusion as to whether the ALJ should respond to the referral
(there is no current provision that allows the Council to consider a
statement in response to the referral). In
[[Page 43849]]
addition, the proposed revision would allow OMHA to collect information
on referrals, assess whether training or policy clarifications for OMHA
adjudicators are necessary, and disseminate the referral to the
appropriate ALJ or attorney adjudicator for his or her information. We
are also proposing at Sec. 405.1110(b)(2) to replace ``all other
parties to the ALJ's decision'' with ``all other parties to the ALJ's
or attorney adjudicator's action'' and at Sec. 405.1110(d) to replace
``ALJ decision'' with ``ALJ or attorney adjudicator action'' to
encompass both decisions and dismissals issued by an ALJ or an attorney
adjudicator, as proposed in section II.B above. We believe that parties
to an ALJ's dismissal or an attorney adjudicator's decision or
dismissal have the same right to receive a copy of another party's
written exceptions to an agency referral as the parties to an ALJ's
decision, and that an ALJ's or attorney adjudicator's decision or
dismissal is binding on the parties to the action. We are proposing to
replace each remaining instance in Sec. Sec. 405.1110 and 423.2110 of
``ALJ'' with ``ALJ or attorney adjudicator,'' ``ALJ's decision or
dismissal'' with ``ALJ's or attorney adjudicator's decision or
dismissal,'' ``ALJ's decision'' with ``ALJ's or attorney adjudicator's
decision or dismissal,'' and ``ALJ's action'' with ``ALJ's or attorney
adjudicator's action.'' These proposed revisions would provide that the
sections apply to decisions and dismissals issued by an attorney
adjudicator, as proposed in section II.B, and therefore CMS and its
contractors would have the same right to refer attorney adjudicator
decisions and dismissals to the Council, and the Council would have the
authority to take the same actions and have the same obligations in
deciding whether to review an attorney adjudicator's decision or
dismissal on its own motion.
Finally, we are proposing at Sec. 423.2110(b)(1) to replace
``material to the outcome of the claim'' with ``material to the outcome
of the appeal'' because unlike Part A and Part B, no ``claim'' is
submitted for drug coverage under Part D.
We are inviting public comments on these proposals. If you choose
to comment on the proposals in this section, please include the caption
``Council reviews on its own motion'' at the beginning of your comment.
f. Content of Request for Review (Sec. Sec. 405.1112 and 423.2112)
Current Sec. Sec. 405.1112 and 423.2112 discuss the content of a
request for Council review. Current Sec. 405.1112(a) requires a
request for Council review to contain the date of the ALJ's decision or
dismissal order, if any, among other information. Current Sec.
423.2112(a)(1) states that the request for Council review must be filed
with the entity specified in the notice of the ALJ's action. Current
Sec. Sec. 405.1112(b) and 423.2112(b) state that the request for
review must identify the parts of the ALJ action with which the party
or enrollee, respectively, requesting review disagrees and explain why
he or she disagrees with the ALJ's decision, dismissal, or other
determination being appealed. Current Sec. 405.1112(b) provides an
example that if the party requesting review believes that the ALJ's
action is inconsistent with a statute, regulation, CMS Ruling, or other
authority, the request for review should explain why the appellant
believes the action is inconsistent with that authority. Current
Sec. Sec. 405.1112(c) and 423.2112(c) state that the Council will
limit its review of an ALJ's action to those exceptions raised by the
party or enrollee, respectively, in the request for review, unless the
appellant is an unrepresented beneficiary or the enrollee is
unrepresented. We are proposing at Sec. Sec. 405.1112 and 423.2112 to
replace ``ALJ's decision or dismissal'' with ``ALJ's or attorney
adjudicator's decision or dismissal,'' ``ALJ action'' with ``ALJ or
attorney adjudicator's action,'' ``ALJ's action'' with ``ALJ's or
attorney adjudicator's action.'' These proposed revisions would provide
that the sections apply to decisions and dismissals issued by an
attorney adjudicator, as proposed in section II.B, and therefore
information on the attorney adjudicator's decision and dismissal must
be included in the request for Council review, and the scope of the
Council's review would be the same as for an ALJ's decision or
dismissal.
Current Sec. 405.1112(a) states that a request for Council review
must be filed with the Council or appropriate ALJ hearing office.
However, this provision may cause confusion when read with current
Sec. 405.1106(a), which states that a request for review must be filed
with the entity specified in the notice of the ALJ's action. In
practice, OMHA notices of decision and dismissal provide comprehensive
appeal instructions directing requests for Council review to be filed
directly with the Council, and provide address and other contact
information for the Council. Therefore, we are proposing to revise
Sec. 405.1112(a) to state that the request for Council review must be
filed with the entity specified in the notice of the ALJ's or attorney
adjudicator's action, which would to align Sec. 405.1112(a) with
current Sec. 405.1106(a), and reaffirm that a request for Council
review must be filed with the entity specified in the notice of the
ALJ's or attorney adjudicator's action.
Current Sec. 405.1112(a) also states that the written request for
review must include the hearing office in which the appellant's request
for hearing is pending if a party is requesting escalation from an ALJ
to the Council. In light of the proposed revisions to the escalation
process discussed in section III.A.3.h.i above, we are proposing to
remove this requirement from Sec. 405.1112(a) because proposed Sec.
405.1016 would provide that a request for escalation is filed with
OMHA. In accordance with proposed Sec. 405.1016, if the request for
escalation meets the requirements of Sec. 405.1016(f)(1) and a
decision, dismissal, or remand cannot be issued within 5 calendar days
after OMHA receives the request, the appeal would be forwarded to the
Council.
We are inviting public comments on these proposals. If you choose
to comment on the proposals in this section, please include the caption
``Content of request for review'' at the beginning of your comment.
g. Dismissal of Request for Review (Sec. Sec. 405.1114 and 423.2114)
We are proposing at Sec. 405.1114(c)(3) to replace ``ALJ hearing''
with ``ALJ's or attorney adjudicator's action.'' This proposed revision
would provide that the paragraph applies to decisions and dismissals
issued by an attorney adjudicator, as proposed in section II.B, and
therefore a valid and timely request for Council review filed by
another party to an attorney adjudicator's decision or dismissal would
preclude dismissal of a request for Council review under Sec.
405.1114(c). We are not proposing any corresponding changes to Sec.
423.1114 because there is no provision equivalent to current Sec.
405.1114(c)(3).
We are inviting public comments on these proposals. If you choose
to comment on the proposals in this section, please include the caption
``Dismissal of request for review'' at the beginning of your comment.
h. Effect of Dismissal of Request for Council Review or Request for
Hearing (Sec. Sec. 405.1116 and 423.2116)
Current Sec. Sec. 405.1116 and 423.2116 describe the effect of a
dismissal by the Council of a request for Council review or a request
for hearing. We are proposing to replace ``ALJ'' with ``ALJ or attorney
adjudicator'' to provide that the denial of a request for Council
review of a dismissal issued by an attorney
[[Page 43850]]
adjudicator is binding and not subject to judicial review in the same
manner as the denial of a request for Council review of a dismissal
issued by an ALJ. We believe the Council's denial of a request to
review an attorney adjudicator's dismissal would be subject to the same
general rules described in sections III.A.3.c and III.A.3.x above
pertaining to reviews of dismissals at the next adjudicative level, and
that further review of the attorney adjudicator's dismissal in Federal
district court would be unavailable.
We are inviting public comments on these proposals. If you choose
to comment on the proposals in this section, please include the caption
``Effect of dismissal of request for Council review or request for
hearing'' at the beginning of your comment.
i. Obtaining Evidence From the Council (Sec. Sec. 405.1118 and
423.2118)
Current Sec. Sec. 405.1118 and 423.2118 provide that a party or an
enrollee, respectively, may request and receive a copy of all or part
of the record of the ALJ hearing. We are proposing to replace ``ALJ
hearing'' with ``ALJ's or attorney adjudicator's action.'' This
proposed revision would provide that a party to an attorney adjudicator
action, or to an ALJ decision that was issued without a hearing, may
request and receive a copy of all or part of the record to the same
extent as a party to an ALJ hearing. We are also proposing to replace
the reference to an ``exhibits list'' with a reference to ``any index
of the administrative record'' to provide greater flexibility in
developing a consistent structure for the administrative record. In
addition, we are proposing at Sec. 405.1118 to replace the reference
to a ``tape'' of the oral proceeding with an ``audio recording'' of the
oral proceeding because tapes are no longer used and a more general
reference would accommodate future changes in recording formats. We are
proposing a parallel revision to Sec. 423.2118 to replace the
reference to a ``CD'' of the oral proceeding with an ``audio
recording'' of the oral proceeding.
We are inviting public comments on these proposals. If you choose
to comment on the proposals in this section, please include the caption
``Obtaining evidence from the Council'' at the beginning of your
comment.
j. What Evidence May Be Submitted to the Council (Sec. Sec. 405.1122
and 423.2122)
Current Sec. Sec. 405.1122 and 423.2122 describe the evidence that
may be submitted to and considered by the Council, the process the
Council follows in issuing subpoenas, the reviewability of Council
subpoena rulings, and the process for seeking enforcement of subpoenas.
Current Sec. 405.1122(a)(1) provides that the Council will limit its
review of the evidence to the evidence contained in the record of the
proceedings before the ALJ, unless the hearing decision decides a new
issue that the parties were not afforded an opportunity to address at
the ALJ level. We are proposing at Sec. 405.1122(a) introductory text
and (a)(1) to replace each instance of ``ALJ's decision'' with ``ALJ's
or attorney adjudicator's decision,'' ``before the ALJ'' with ``before
the ALJ or attorney adjudicator,'' and ``the ALJ level'' with ``the
OMHA level.'' We believe the standard for review of evidence at the
Council level would be the same regardless of whether the case was
decided by an ALJ or attorney adjudicator, as proposed in section II.B
above, at the OMHA level. We are also proposing corresponding revisions
to Sec. 423.2122(a) introductory text and (a)(1). Also, to help ensure
it is clear that the exception for evidence related to new issues
raised at the OMHA level is not limited to proceedings in which a
hearing before an ALJ was conducted, we are proposing at Sec. Sec.
405.1122(a)(1) and Sec. 423.2122(a)(1) to replace ``hearing decision''
with ``ALJ's or attorney adjudicator's decision.'' Current Sec.
405.1122(a)(2) provides that if the Council determines that additional
evidence is needed to resolve the issues in the case, and the hearing
record indicates that the previous decision-makers have not attempted
to obtain the evidence, the Council may remand the case to an ALJ to
obtain the evidence and issue a new decision. For the reasons described
above, we are proposing at Sec. 405.1122(a)(2) to replace ``ALJ'' with
``ALJ or attorney adjudicator'' and ``hearing record'' with
``administrative record,'' along with corresponding revisions to Sec.
423.2122(a)(2). Current Sec. 405.1122(b)(1) describes the evidence
that may be considered by the Council when a case is escalated from the
ALJ level. For the reasons described above, we are proposing to replace
``ALJ level'' with ``OMHA level.'' We are not proposing any
corresponding changes to Sec. 423.2122 because escalation is not
available for Part D coverage appeals. Finally, we are proposing to
replace all remaining instances of ``ALJ'' in Sec. 405.1122(b)(1),
(b)(2), (c)(2), (c)(3) introductory text, (c)(3)(i), and (c)(3)(ii)
with ``ALJ or attorney adjudicator,'' as we believe the Council's
authority to consider evidence entered in the record by an attorney
adjudicator and to remand a case to an attorney adjudicator for
consideration of new evidence would be the same as the Council's
current authority to consider evidence entered in the record by an ALJ
and remand a case to an ALJ. We are not proposing any corresponding
changes to Sec. 423.2122 because there are no remaining references to
``ALJ.''
We are inviting public comments on these proposals. If you choose
to comment on the proposals in this section, please include the caption
``What evidence may be submitted to the Council'' at the beginning of
your comment.
k. Case Remanded by the Council (Sec. Sec. 405.1126 and 423.2126)
Current Sec. Sec. 405.1126(a) and (b) explain the Council's remand
authority. We are proposing to replace each instance of ``ALJ'' with
``ALJ or attorney adjudicator'' to provide that the Council may remand
a case in which additional evidence is needed or additional action is
required by the ALJ or attorney adjudicator, as proposed in section
II.B above. Proposed Sec. 405.1126(b) would also provide that an ALJ
or attorney adjudicator would take any action that is ordered by the
Council, and may take any additional action that is not inconsistent
with the Council's remand order. We believe it is necessary for the
Council to have the same authority to remand an attorney adjudicator's
decision to the attorney adjudicator as the Council currently has to
remand an ALJ's decision to the ALJ, and that the attorney
adjudicator's actions with respect to the remanded case should be
subject to the same requirements as an ALJ's actions under the current
provisions. We are also proposing corresponding revisions to Sec.
423.2126(a)(1) and (a)(2). Current Sec. Sec. 405.1126(c) and (d)
describe the procedures that apply when the Council receives a
recommended decision from the ALJ, including the right of the parties
to file briefs or other written statements with the Council. Because we
are proposing in Sec. 405.1126(a) for the Council to have the same
authority to order an attorney adjudicator to issue a recommended
decision on remand as the Council currently has to order an ALJ to
issue a recommended decision, we are also proposing at Sec.
405.1126(c) and (d) to replace ``ALJ'' with ``ALJ or attorney
adjudicator'' to provide that the provisions apply to attorney
adjudicators to the same extent as the provisions apply to ALJs, along
with corresponding revisions to Sec. 423.2126(a)(3) and (a)(4).
Finally, current Sec. 405.1126(e)(2) provides that if
[[Page 43851]]
the Council determines more evidence is required after receiving a
recommended decision, the Council may again remand the case to an ALJ
for further development and another decision or recommended decision.
Because we believe the Council should have the same authority to remand
a case to an attorney adjudicator following receipt of a recommended
decision, we are proposing at Sec. 405.1126(e)(2) to replace ``ALJ''
with ``ALJ or attorney adjudicator,'' along with a corresponding
revision to Sec. 423.2126(a)(5)(ii), and to insert ``if applicable''
after rehearing because a rehearing may not be applicable in every
circumstance (for example, where an attorney adjudicator issued a
recommended decision and the Council does not remand with instructions
to transfer the appeal to an ALJ for a hearing).
We are inviting public comments on these proposals. If you choose
to comment on the proposals in this section, please include the caption
``Case remanded by the Council'' at the beginning of your comment.
l. Action of the Council (Sec. Sec. 405.1128 and 423.2128)
Current Sec. Sec. 405.1128 and 423.2128 explain the actions the
Council may take after reviewing the administrative record and any
additional evidence (subject to the limitations on Council
consideration of additional evidence). We are proposing at Sec. Sec.
405.1128(a) and 423.2128(a) to replace ``ALJ'' with ``ALJ or attorney
adjudicator,'' which would provide that the Council may make a decision
or remand a case to an ALJ or to an attorney adjudicator (as proposed
in section II.B above). We believe the Council should have the same
authority to remand a case to an attorney adjudicator as the Council
currently has to remand a case to an ALJ. Also, to help ensure there is
no confusion that Council actions are not limited to proceedings in
which a hearing before an ALJ was conducted, we are proposing at
Sec. Sec. 405.1128(b) and 423.2128(b) to replace ``the ALJ hearing
decision'' with ``the ALJ's or attorney adjudicator's decision.''
We are inviting public comments on these proposals. If you choose
to comment on the proposals in this section, please include the caption
``Action of the Council'' at the beginning of your comment.
m. Request for Escalation to Federal Court (Sec. 405.1132)
Current Sec. 405.1132 explains the process for an appellant to
seek escalation of an appeal (other than an appeal of an ALJ dismissal)
from the Council to Federal district court if the Council does not
issue a decision or dismissal or remand the case to an ALJ within the
adjudication time frame specified in Sec. 405.1100, or as extended as
provided in subpart I. We are proposing at Sec. 405.1132 to replace
each instance of ``ALJ'' with ``ALJ or attorney adjudicator.'' These
revisions would provide that the appellant may request that escalation
of a case, other than a dismissal issued by an ALJ or attorney
adjudicator, as proposed in section II.B above to Federal district
court if the Council is unable to issue a decision or dismissal or
remand the case to an ALJ or attorney adjudicator within an applicable
adjudication time frame, and that appellants may file an action in
Federal district court if the Council is not able to issue a decision,
dismissal, or remand to the ALJ or attorney adjudicator within 5
calendar days of receipt of the request for escalation or 5 calendar
days from the end of the applicable adjudication time period. We are
not proposing any corresponding changes to part 423, subpart U, as
there is no equivalent provision because there are no escalation rights
for Part D coverage appeals.
We are inviting public comments on these proposals. If you choose
to comment on the proposals in this section, please include the caption
``Request for escalation to Federal court'' at the beginning of your
comment.
n. Judicial Review (Sec. Sec. 405.1136, 423.1976, and 423.2136)
Current Sec. Sec. 405.1136, 423.1976, and 423.2136 set forth the
right to file a request for judicial review in Federal district court
of a Council decision (or of an ALJ's decision if the Council declines
review as provided in Sec. 423.1976(a)(1)). Current Sec. 405.1136
also provides that judicial review in Federal district court may be
requested if the Council is unable to issue a decision, dismissal, or
remand within the applicable time frame following an appellant's
request for escalation. In addition, current Sec. Sec. 405.1136 and
423.2136 specify the requirements and procedures for filing a request
for judicial review, the Federal district court in which such actions
must be filed, and describe the standard of review. We are proposing at
Sec. Sec. 405.1136, 423.1976, and 423.2136 to replace each instance of
``ALJ'' with ``ALJ or attorney adjudicator,'' and ``ALJ's'' with
``ALJ's or attorney adjudicator's'' to help ensure that there is no
confusion that appellants may file a request for judicial review in
Federal district court of actions made by an attorney adjudicator, as
proposed in section II.B above (or by the Council following an action
by an attorney adjudicator), to the same extent that judicial review is
available for ALJ actions (or Council actions following an action by an
ALJ).
We are inviting public comments on these proposals. If you choose
to comment on the proposals in this section, please include the caption
``Judicial review'' at the beginning of your comment.
o. Case Remanded by a Federal Court (Sec. Sec. 405.1138 and 423.2138)
Current Sec. Sec. 405.1138 and 423.2138 set forth the actions the
Council may take when a Federal district court remands a case to the
Secretary for further consideration. We are proposing at Sec. Sec.
405.1138 and 423.2138, and 405.1140 and 423.2140 to replace ``ALJ''
with ``ALJ or attorney adjudicator'' to provide that when a case is
remanded by a Federal district court for further consideration by the
Secretary, the Council may remand the case to an ALJ or attorney
adjudicator (as proposed in section II.B above), to issue a decision,
take other action, or return the case to the Council with a recommended
decision.
We are inviting public comments on these proposals. If you choose
to comment on the proposals in this section, please include the caption
``Case remanded by a Federal court'' at the beginning of your comment.
p. Council Review of ALJ Decision in a Case Remanded by a Federal
District Court (Sec. Sec. 405.1140 and 423.2140)
Current Sec. Sec. 405.1140 and 423.2140 set forth the procedures
that apply when a case is remanded to the Secretary for further
consideration, and the Council subsequently remands the case to an ALJ,
including the procedures for the Council to assume jurisdiction
following the decision of the ALJ on its own initiative or upon receipt
of written exceptions from a party or the enrollee. We are proposing to
replace each instance of ``ALJ'' throughout Sec. Sec. 405.1140 and
423.2140 with ``ALJ or attorney adjudicator'' and to replace the
reference to ``ALJ's'' at Sec. Sec. 405.1140(d) and 423.2140(d) with
``ALJ's or attorney adjudicator's.'' These revisions would provide that
the Council may remand these cases to the ALJ or attorney adjudicator,
as proposed in section II.B above, following remand from a Federal
district court, and that the decision of the ALJ or attorney
adjudicator becomes the final decision of the Secretary after remand
unless the Council assumes
[[Page 43852]]
jurisdiction. These revisions would further apply the rules set forth
in this section to cases reviewed by an attorney adjudicator as well as
an ALJ. As described above in relation to the Council's general remand
authority under Sec. Sec. 405.1126 and 423.2126, we believe it is
necessary for the Council to have the same authority to remand an
attorney adjudicator's decision to the attorney adjudicator as the
Council currently has to remand an ALJ's decision to the ALJ, and that
would include cases that are remanded by a Federal district court to
the Secretary for further consideration.
We are inviting public comments on these proposals. If you choose
to comment on the proposals in this section, please include the caption
``Council review of ALJ decision in a case remanded by a Federal
district court'' at the beginning of your comment.
B. Part 405, Subpart J Expedited Reconsiderations (Sec. 405.1204)
In accordance with section 1869(b)(1)(F) of the Act, current Sec.
405.1204 provides for expedited QIC reconsiderations of certain QIO
determinations related to provider-initiated terminations of Medicare-
covered services and beneficiary discharges from a provider's facility.
Current Sec. 405.1204(c)(4)(iii) explains that the QIC's initial
notification may be done by telephone followed by a written notice that
includes information about the beneficiary's right to appeal the QIC's
reconsideration decision to an ALJ, and current Sec. 405.1204(c)(5)
provides that if the QIC does not issue a decision within 72 hours of
receipt of the request for a reconsideration, the case can be escalated
to the ``ALJ hearing level.'' For consistency with part 405, subpart I,
and to explain the rules that apply to an ALJ hearing, we are proposing
at Sec. 405.1204(c)(4)(iii) and (c)(5) to amend these references to
convey that a QIC reconsideration can be appealed to, or a request for
a QIC reconsideration can be escalated to OMHA for an ALJ hearing in
accordance with part 405, subpart I. We believe these revisions would
explain where a request for an ALJ hearing is directed from a subpart J
proceeding, and the rules that would be applied to the request for an
ALJ hearing following the QIC's reconsideration or escalation of the
request for a QIC reconsideration.
Current Sec. 405.1204(c)(5) states that the beneficiary has a
right to escalate a request for a QIC reconsideration if the amount
remaining in controversy after the QIO determination is $100 or more.
However, this is inconsistent with the amount in controversy specified
in section 1869(b)(1)(E) of the Act. We are proposing to revise Sec.
405.1204(c)(5) to provide that there is a right to escalate a request
for a QIC reconsideration if the amount remaining in controversy after
the QIO determination meets the requirements for an ALJ hearing under
Sec. 405.1006. We believe that this is more consistent with section
1869(b)(1)(E) of the Act, which provides that a hearing by the
Secretary shall not be available to an individual if the amount in
controversy is less than $100, as adjusted annually after 2004, which
is implemented in Sec. 405.1006, and would bring consistency to the
amounts in controversy required for an escalation under subpart J and
subpart I.
We are inviting public comments on these proposals. If you choose
to comment on the proposals in this section, please include the caption
``Part 405, subpart J expedited reconsiderations'' at the beginning of
your comment.
C. Part 422, Subpart M
1. General Provisions (Sec. 422.562)
Current Sec. 422.562(c)(1)(ii) states that if an enrollee receives
immediate QIO review of a determination of non-coverage of inpatient
hospital care, the QIO review decision is subject only to the appeal
procedures set forth in parts 476 and 478 of title 42, chapter IV.
However, we believe this provision is an outdated reference that has
been superseded by current Sec. 422.622, which provides for requesting
immediate QIO review of the decision to discharge an enrollee from an
inpatient hospital setting and appeals of that review as described
under part 422, subpart M. The regulatory provisions at Sec. 422.622
describe the processes for QIO review of the decision to discharge an
MA enrollee from the inpatient hospital setting. Section 422.622 also
explains the availability of other appeals processes if the enrollee
does not meet the deadline for an immediate QIO review of the discharge
decision. These part 422, subpart M provisions govern the review
processes for MA enrollees disputing discharge from an inpatient
hospital setting. As noted above, we believe the references to the
procedures in parts 476 and 478 at Sec. 422.562(c)(1)(ii) are
obsolete. Therefore, we are proposing to delete Sec. 422.562(c)(1) to
remove the outdated reference in current Sec. 422.562(c)(1)(ii) and
consolidate current (c)(1) and (c)(1)(i) into proposed (c)(1). We also
note that changes to Sec. 422.562(d) are proposed and discussed in
section II.C, above.
We are inviting public comments on these proposals. If you choose
to comment on the proposals in this section, please include the caption
``General provisions'' at the beginning of your comment.
2. Notice of Reconsidered Determination by the Independent Entity
(Sec. 422.594)
Current Sec. 422.594(b)(2) requires the notice of the
reconsideration determination by an IRE to inform the parties of their
right to an ALJ hearing if the amount in controversy is $100 or more,
if the determination is adverse (does not completely reverse the MAO's
adverse organization determination). We are proposing at Sec.
422.594(b)(2) to amend this requirement so that the notice informs the
parties of their right to an ALJ hearing if the amount in controversy
meets the requirements of Sec. 422.600, which in turn refers to the
part 405 computation of the amount in controversy. We believe this
would increase accuracy in conveying when a party has a right to an ALJ
hearing, and would be more consistent with section 1852(g)(5) of the
Act, which provides that a hearing by the Secretary shall not be
available to an individual if the amount in controversy is less than
$100, as adjusted annually in accordance with section
1869(b)(1)(E)(iii) of the Act, which is implemented in part 405 at
Sec. 405.1006. We discuss proposed changes to Sec. 405.1006 in
section III.A.3.d above.
We are inviting public comments on these proposals. If you choose
to comment on the proposals in this section, please include the caption
``Notice of reconsidered determination by the independent entity'' at
the beginning of your comment.
3. Request for an ALJ Hearing (Sec. 422.602)
Current Sec. 422.602(b) provides that a party must file a request
for an ALJ hearing within 60 days of the date of the notice of the
IRE's reconsidered determination. However, in similar appeals brought
under Medicare Part A and Part B at Sec. 405.1002, and Part D at Sec.
423.2002, a request for an ALJ hearing must be filed within 60 calendar
days of receipt of a notice of reconsideration. We are proposing at
Sec. 422.602(b)(1) to align the part 422 time frame for filing a
request for an ALJ hearing with provisions for similar appeals under
Medicare Part A and Part B, and Part D. As proposed, a request for an
ALJ hearing would be required to be filed within 60 calendar days of
receiving the notice of a reconsidered determination, except when the
time frame is extended by an ALJ or, as proposed, attorney
[[Page 43853]]
adjudicator, as provided in part 405. To provide consistency for when a
notice of a reconsidered determination is presumed to have been
received, we are proposing at Sec. 422.602(b)(2) that the date of
receipt of the reconsideration is presumed to be 5 calendar days after
the date of the notice of the reconsidered determination, unless there
is evidence to the contrary, which is the same presumption that is
applied to similar appeals under Medicare Part A and Part B at Sec.
405.1002, and Part D at Sec. 423.2002.
We are inviting public comments on these proposals. If you choose
to comment on the proposals in this section, please include the caption
``Request for an ALJ hearing'' at the beginning of your comment.
4. Medicare Appeals Council (Council) Review (Sec. 422.608)
Current Sec. 422.608 provides that any party to the hearing,
including the MAO, who is dissatisfied with the ALJ hearing decision
may request that the Council review the ALJ's decision or dismissal. We
believe that the reference to a hearing, hearing decision, then
decision or dismissal may cause confusion regarding a party's right to
request Council review. We are proposing at Sec. 422.608 that any
party to the ALJ's or, as proposed in section II.B above, attorney
adjudicator's decision or dismissal, including the MAO, who is
dissatisfied with the decision or dismissal, may request that the
Council review the decision or dismissal. We believe this would resolve
any potential confusion regarding a party's right to request Council
review of a decision when a hearing was not conducted, and a dismissal
of a request for hearing, and provide that the section applies to
decisions and dismissals issued by an attorney adjudicator, as proposed
in section II.B. Therefore, proposed Sec. 422.608 would provide that a
request for Council review may be filed by a party if he or she is
dissatisfied with an ALJ's or attorney adjudicator's decision or
dismissal.
We are inviting public comments on these proposals. If you choose
to comment on the proposals in this section, please include the caption
``Medicare Appeals Council (Council) review'' at the beginning of your
comment. We discuss other proposed changes to Sec. 422.608 in section
II.D above.
5. Judicial Review (Sec. 422.612)
Current Sec. 422.612 provides the circumstances under which a
party may request judicial review of an ALJ or Council decision, and
directs appellants to the procedures in part 405 for filing a request
for judicial review. We are proposing at Sec. 422.612(a) to replace
each instance of ``ALJ's'' with ``ALJ's or attorney adjudicator's''.
Thus, as provided in Sec. 422.612(a), appellants would be able to file
a request for judicial review in Federal district court of actions made
by an attorney adjudicator, as proposed in section II.B above (or by
the Council following an action by an attorney adjudicator), to the
same extent that judicial review is available under Sec. 412.622(a)
for ALJ actions (or Council actions following an action by an ALJ).
We are inviting public comments on these proposals. If you choose
to comment on the proposals in this section, please include the caption
``Judicial review'' at the beginning of your comment.
6. Reopening and Revising Determinations and Decisions (Sec. 422.616)
Current Sec. 422.616(a) provides that the determination or
decision of an MA organization, independent entity, ALJ, or the Council
that is otherwise final and binding may be reopened and revised by the
entity that made the determination or decision, subject to the rules in
part 405. We are proposing at Sec. 422.616(a) to replace ``ALJ'' with
``ALJ or attorney adjudicator.'' As described in section III.A.2.l
above with respect to Sec. Sec. 405.980, 405.982, 405.984, 423.1980,
423.1982, and 423.1984, we believe it is necessary for an attorney
adjudicator to have the authority to reopen the attorney adjudicator's
decision on the same bases as an ALJ may reopen the ALJ's decision
under the current rules, and the action should be subject to the same
limitations and requirements, and have the same effects as an ALJ's
action under these provisions.
We are inviting public comments on these proposals. If you choose
to comment on the proposals in this section, please include the caption
``Reopening and revising determinations and decisions'' at the
beginning of your comment.
7. How an MA Organization Must Effectuate Standard Reconsideration
Determinations and Decisions, and Expedited Reconsidered Determinations
(Sec. Sec. 422.618 and 422.619)
Current Sec. 422.618(c)(1) and (c)(2) provide instructions for
effectuation of decisions issued by an ALJ, or at a higher level of
appeal, that reverse an IRE's decision on a standard reconsidered
determination or decision. We are proposing to replace ``ALJ'' with
``ALJ or attorney adjudicator'' at Sec. 422.618(c)(1) and to make
corresponding changes to Sec. 422.619(c)(1) for decisions that reverse
an IRE's decision on an expedited reconsidered determination or
decision. We believe the process for effectuating the decision of an
attorney adjudicator, as proposed in section II.B above, should be the
same as the process for effectuating the decision of an ALJ.
We are inviting public comments on these proposals. If you choose
to comment on the proposals in this section, please include the caption
``How an MA organization must effectuate standard reconsideration
determinations and decisions, and expedited reconsidered
determinations'' at the beginning of your comment.
8. Requesting Immediate QIO Review of the Decision to Discharge From
the Inpatient Hospital and Fast-Track Appeals of Service Terminations
to Independent Review Entities (IREs) (Sec. Sec. 422.622 and 422.626).
In accordance with section 1852(g)(3) and (g)(4) of the Act,
current Sec. Sec. 422.622 and 422.626 provide for reviews of QIO
determinations and expedited IRE reconsiderations of certain QIO
determinations related to terminations of covered provider services
furnished by home health agencies (HHAs), skilled nursing facilities
(SNFs), and comprehensive outpatient rehabilitation facilities (CORFs)
to a Medicare Advantage enrollee, and Medicare Advantage enrollee
discharges from an inpatient hospital. Current Sec. 422.622(g)
provides that if an enrollee is still an inpatient in the hospital
after a QIO determination reviewing a provider discharge from a
hospital, the enrollee may request an IRE reconsideration of the QIO
determination in accordance with Sec. 422.626(g); and if an enrollee
is no longer an inpatient in the hospital, the enrollee may appeal the
QIO determination to an ALJ. Current Sec. 422.626(g)(3) provides that
if the IRE reaffirms its decision to terminate covered provider
services furnished by a HHA, SNF, or CORF in whole or in part, the
enrollee may appeal the IRE's reconsidered determination to an ALJ. We
are proposing at Sec. Sec. 422.622(g)(2) and 422.626(g)(3) to amend
these references to provide that the appeal is made to OMHA for an ALJ
hearing. We believe these revisions would clarify where a request for
an ALJ hearing is directed.
We are inviting public comments on these proposals. If you choose
to comment on the proposals in this section, please include the caption
``Requesting immediate QIO review of the decision to discharge from the
[[Page 43854]]
inpatient hospital and fast-track appeals of service terminations to
independent review entities (IREs)'' at the beginning of your comment.
D. Part 478, Subpart B
1. Applicability and Beneficiary's Right to a Hearing (Sec. Sec.
478.14 and 478.40)
Current Sec. 478.14(c)(2) explains that for the purposes of part
478 reconsideration and appeals, limitation of liability determinations
on excluded coverage of certain services are made under section 1879 of
the Act, and initial determinations under section 1879 of the Act and
further appeals are governed by the reconsideration and appeal
procedures in part 405, subpart G for determinations under Medicare
Part A, and part 405, subpart H for determinations under Medicare Part
B. In addition, current Sec. 478.40 states that an ALJ hearing may be
obtained from the SSA Office of Hearings and Appeals, and the
provisions of subpart G of 42 CFR part 405 apply unless they are
inconsistent with the specific provisions of subpart B of 42 CFR part
478. These references are outdated. Since Sec. Sec. 478.14 and 478.40
were last updated in 1999, section 931 of the MMA transferred
responsibility for the ALJ hearing function from SSA to HHS, and HHS
established OMHA in 2005, to administer the ALJ hearing function,
including ALJ hearings conducted under titles XI and XVIII of the
Social Security Act (see 70 FR 36386). In addition, BIPA and the MMA
established new appeal procedures that were implemented in 2005, at 42
CFR part 405, subpart I (70 FR 11420), and the portions of subparts G
and H that previously applied to part 478, subpart B appeals were
removed in 2012 (77 FR 29002). Proposed Sec. Sec. 478.14 and 478.40
would replace the current outdated references to part 405, subparts G
and H, with references to part 405, subpart I. Proposed Sec. 478.40
would also update the reference to the entity with responsibility for
the ALJ hearing function by replacing the SSA Office of Hearings and
Appeals with OMHA.
We are inviting public comments on these proposals. If you choose
to comment on the proposals in this section, please include the caption
``Applicability and beneficiary's right to a hearing'' at the beginning
of your comment.
2. Submitting a Request for a Hearing (Sec. 478.42)
Similar to current Sec. 478.40, as discussed above, current Sec.
478.42(a) has outdated references to SSA offices that are no longer
involved in the Medicare claim appeals process. In addition, current
Sec. 478.42(a) permits beneficiaries to file requests for an ALJ
hearing with other entities, which could cause significant delays in
obtaining a hearing before an OMHA ALJ. Proposed Sec. 478.42(a) would
direct beneficiaries to file a request for an ALJ hearing with the OMHA
office identified in the QIO's notice of reconsidered determination.
This revision would be clearer for beneficiaries, who are provided with
appeal instructions by the QIOs, and reduce delays in obtaining a
hearing by an OMHA ALJ.
Current Sec. 478.42(b) requires that a request for hearing is
filed within 60 calendar days of receipt of the notice of the QIO
reconsidered determination and the date of receipt is assumed to be 5
days after the date on the notice unless there is a reasonable showing
to the contrary. Current Sec. 478.42(b) also provides that a request
is considered filed on the date it is postmarked. To align part 478,
subpart B with procedures for requesting an ALJ hearing under part 405,
subpart I; part 422, subpart M; and part 423, subpart U, proposed Sec.
478.42(b) would provide that the request for hearing must be filed
within 60 ``calendar'' days of receiving notice of the QIO reconsidered
determination and that the notice is presumed to be received 5
``calendar'' days after the date of the notice. In addition, to further
align the part 478, subpart B procedures for requesting an ALJ hearing
with the other parts, proposed Sec. 478.42(c) would amend the standard
to demonstrate that notice of QIO reconsidered determination was not
received within 5 calendar days by requiring ``evidence'' rather than
the current ``reasonable showing,'' and would also revise when a
request is considered filed, from the date it is postmarked to the date
it is received by OMHA. These changes would create parity with requests
for hearing filed by beneficiaries and enrollees for similar services
but under other parts of title 42, chapter IV.
We are inviting public comments on these proposals. If you choose
to comment on the proposals in this section, please include the caption
``Submitting a request for a hearing'' at the beginning of your
comment.
3. Determining the Amount in Controversy (Sec. 478.44)
Current Sec. 478.44(a) explains how the amount in controversy for
an ALJ hearing is determined in part 478, subpart B hearings. Current
Sec. 478.44(a) has outdated references to Sec. Sec. 405.740 and
405.817 from part 405, subparts G and H respectively, for calculating
the amount in controversy for an individual appellant or multiple
appellants. In 2012, subpart G was removed and subpart H was
significantly revised and no longer applies to Medicare claim appeals
(77 FR 29002). To update these reference to the current part 405 rules,
proposed Sec. 478.44(a) would replace the outdated cross-references
for calculating the amount in controversy with Sec. 405.1006(d) and
(e), which describe the calculation for determining the amount in
controversy and the standards for aggregating claims by an individual
appellant or multiple appellants. We discuss proposed changes to Sec.
405.1006 in section III.A.3.d above.
Current Sec. 478.44(b) and (c) explain that if an ALJ determines
the amount in controversy is less than $200, the ALJ, without holding a
hearing, notifies the parties to the hearing, and if a request for
hearing is dismissed because the amount in controversy is not met, a
notice will be sent to the parties to the hearing. However, when a
request for hearing is dismissed because the amount in controversy is
not met, no hearing is conducted and the parties are parties to the
proceedings regardless of whether a hearing was conducted. To prevent
potential confusion, proposed Sec. 478.44(b) and (c) would replace
``parties to the hearing'' with ``parties'' so it is understood that
they are parties regardless of whether a hearing is conducted. Because
an attorney adjudicator would have to determine whether appeals
assigned to him or her, as proposed in section II.B above, meet the
amount in controversy requirement, we also propose at Sec. 478.44(a)
and (b) that an attorney adjudicator may determine that the amount in
controversy, and may determine the amount in controversy is less than
$200 and notify the parties to submit additional evidence to prove that
the amount in controversy is at least $200. However, because we are not
proposing that an attorney adjudicator can dismiss a request for an ALJ
hearing because the amount in controversy is not met, proposed Sec.
478.44(c) provides that an ALJ would dismiss a request if at the end of
the 15-day period to submit additional evidence to prove that the
amount in controversy is at least $200, the ALJ determines that the
amount in controversy is less than $200.
We are inviting public comments on these proposals. If you choose
to comment on the proposals in this section, please include the caption
``Determining the amount in controversy'' at the beginning of your
comment.
[[Page 43855]]
4. Medicare Appeals Council and Judicial Review (Sec. 478.46)
Current Sec. 478.46(a) states that the Council will review an
ALJ's hearing decision or dismissal under the same circumstances as
those set forth at 20 CFR 404.970, which is now an outdated reference
to SSA Appeals Council procedures for Council review. We are proposing
at Sec. 478.46(a) to replace the outdated reference to 20 CFR 404.970
with references to current Sec. Sec. 405.1102 (``Request for Council
review when ALJ or attorney adjudicator issued a decision or
dismissal'') and 405.1110 (``Council reviews on its own motion''). In
addition, we are proposing in Sec. 478.46(a) and (b) to replace
``hearing decision'' with ``decision,'' and ``ALJ'' with ``ALJ or
attorney adjudicator'' because hearings are not always conducted and a
decision can generally be appealed regardless of whether a hearing was
conducted, and attorney adjudicators may issue decisions or dismissals
for which Council review may be requested, as proposed in section II.B
above.
We are inviting public comments on these proposals. If you choose
to comment on the proposals in this section, please include the caption
``Medicare Appeals Council and judicial review'' at the beginning of
your comment.
5. Reopening and Revision of a Reconsidered Determination or a Decision
(Sec. 478.48)
The title of current Sec. 478.48 references reopenings and
revisions of reconsidered determinations and hearing decisions, and
current Sec. 478.48 has an outdated reference to subpart G of 42 CFR
part 405 for the procedures for reopening a decision by an ALJ or the
Departmental Appeals Board.
We are proposing to revise the title of Sec. 478.48 to replace
``hearing decision'' with ``decision,'' and in proposed paragraphs (b)
and (c) to replace ``ALJ'' with ``ALJ or attorney adjudicator'' so the
provision is understood to apply to decisions by ALJs, regardless of
whether a hearing was conducted, or, as proposed in section II.B above,
attorney adjudicators, as well as review decisions, which are conducted
by the Medicare Appeals Council at the Departmental Appeals Board. We
also propose at Sec. 478.48(b) to replace the outdated reference to
Sec. 405.750(b), which was part of the now removed part 405, subpart G
(77 FR 29016 through 29018), with Sec. 405.980, which is the current
part 405, subpart I reopening provision.
We are inviting public comments on these proposals. If you choose
to comment on the proposals in this section, please include the caption
``Reopening and revision of a reconsidered determination or a
decision'' at the beginning of your comment.
IV. Collection of Information Requirements
Under the Paperwork Reduction Act of 1995 (PRA), we are required to
provide 60-day notice in the Federal Register and solicit public
comment before a collection of information requirement is submitted to
the Office of Management and Budget (OMB) for review and approval. In
order to fairly evaluate whether an information collection should be
approved by OMB, section 3506(c)(2)(A) of the PRA requires that we
solicit comment on the following issues:
The need for the information collection and its usefulness
in carrying out the proper functions of our agency.
The accuracy of our estimate of the information collection
burden.
The quality, utility, and clarity of the information to be
collected.
Recommendations to minimize the information collection
burden on the affected public, including automated collection
techniques.
Therefore, we are soliciting public comments on each of these
issues for the information collection requirements discussed below.
The PRA exempts most of the information collection activities
referenced in this proposed rule. In particular, the implementing
regulations of the PRA at 5 CFR 1320.4 exclude collection activities
during the conduct of a civil action to which the United States or any
official or agency thereof is a party. Civil actions include
administrative actions such as redeterminations, reconsiderations, and/
or appeals. Specifically, these actions are taken after the initial
determination or a denial of payment, or MAO organization determination
or Part D plan sponsor coverage determination. However, one requirement
contained in this proposed rule is subject to the PRA because the
burden is imposed prior to an administrative action or denial of
payment. This requirement is discussed below.
In summary, we are proposing at Sec. 405.910 that when a provider
or supplier is the party appointing a representative, the appointment
of representation would include the Medicare National Provider
Identifier (NPI) of the provider or supplier that furnished the item of
service. Although this is a new regulatory requirement, the current
Medicare Claims Processing Manual already states that the NPI should be
included when a provider or supplier appoints a representative. The
standardized form for appointing a representative, Form CMS-1696,
currently provides a space for the information in question.
Importantly, this form is currently approved under OMB control number
0938-0950 and expires June 30, 2018.
The burden associated with this requirement is the time and effort
of an individual or entity who is a provider or supplier to prepare an
appointment of representation containing the NPI. As stated earlier,
this requirement and the related burden are subject to the PRA;
however, because we believe that this information is already routinely
being collected, we estimate there would be no additional burden for
completing an appointment of representative in accordance with proposed
405.910.
If you wish to view the standardized form and the supporting
documentation, you can download a copy from the CMS Web site at https://www.cms.gov/medicare/cms-forms/cms-forms/cms-forms-list.html.
We have submitted a copy of this proposed rule to OMB for its
review of the information collection requirements described above.
We are inviting public comment on the burden associated with these
information collection requirements.
V. Response to Comments
Because of the large number of public comments we normally receive
on Federal Register documents, we are not able to acknowledge or
respond to them individually. We will consider all comments we receive
by the date and time specified in the DATES section of this proposed
rule, and, when we proceed with a subsequent document, we will respond
to the comments in the preamble to that document.
VI. Regulatory Impact Statement
We have examined the impacts of this proposed rule as required by
Executive Order 12866 on Regulatory Planning and Review (September 30,
1993), Executive Order 13563 on Improving Regulation and Regulatory
Review (January 18, 2011), the Regulatory Flexibility Act (RFA)
(September 19, 1980, Pub. L. 96-354), section 1102(b) of the Social
Security Act, section 202 of the Unfunded Mandates Reform Act of 1995
(March 22, 1995; Pub. L. 104-4), Executive Order 13132 on Federalism
(August 4, 1999) and the Congressional Review Act (5 U.S.C. 804(2)).
[[Page 43856]]
Executive Orders 12866 and 13563 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). A
regulatory impact analysis (RIA) must be prepared for major rules with
economically significant effects ($100 million or more in any 1 year).
We have determined that the effect of this proposed rule does not reach
this economic threshold and thus is not considered a major rule. As
detailed above, this proposed rule would only make minimal changes to
the existing Medicare appeals procedures for claims for benefits under
or entitlement to the original Medicare programs, and coverage of
items, services, and drugs under the Medicare Advantage and voluntary
Medicare prescription drug programs. Thus, this proposed rule would
have negligible financial impact on beneficiaries and enrollees,
providers or suppliers, Medicare contractors, MAOs, and Part D plan
sponsors, but would derive benefits to the program and appellants.
HHS recognizes that the current appeals backlog is a matter of
great significance, and it has made it a priority to adopt measures
that are designed to reduce the backlog and improve the overall
Medicare appeals process moving forward. To that end, HHS has initiated
a series of measures, including this proposed regulation, that are
aimed at both reducing the backlog and creating a more efficient
Medicare appeals system.
We believe the changes proposed in this regulation will help
address the Medicare appeals backlog and create efficiencies at the ALJ
level of appeal by allowing OMHA to reassign a portion of workload to
non-ALJ adjudicators, reduce appeals of low-value claims, and reduce
procedural ambiguities that result in unproductive efforts at OMHA and
unnecessary appeals to the Medicare Appeals Council. In addition, the
other proposed changes, including precedential decisions and generally
limiting CMS and CMS contractor participation or party status at the
OMHA level unless the ALJ determines participation by additional
entities is necessary for a full examination of the matters at issue
(as provided in proposed Sec. Sec. 405.1010(d) and 405.1012(d)), will
collectively make the ALJ hearing process more efficient through
streamlined and standardized procedures and more consistent decisions,
and reduce appeals to the Medicare Appeals Council.
In particular, we are able to estimate the impact from two of the
proposed modifications: proposals to expand the pool of adjudicators
and the modifications to calculating the amount in controversy (AIC)
required for an ALJ hearing. Based on FY 2015, and an assumption that
future years are similar to FY 2015, we estimate that the proposals to
expand the pool of adjudicators at OMHA could redirect approximately
23,650 appeals per year to attorney adjudicators to process these
appeals at a lower cost than would be required if only ALJs were used
to address the same workload. If the number of requests for hearing,
waivers of oral hearing, requests for review of a contractor dismissal,
or appellant withdrawals of requests for hearing vary from FY 2015 in
future years then the number of appeals potentially addressed by
attorney adjudicators would likely also vary. Additionally, based on FY
2015 requests for an ALJ hearing, we estimate that revising the
calculation methodology for the AIC required for an ALJ hearing could
remove appeals related to over 2,600 Part B low-value claims per year
from the ALJ hearing process, after accounting for the likelihood of
appellants aggregating claims to meet the AIC. We also note that
appeals filed by Medicare beneficiaries, and Medicare Advantage and
Part D prescription drug plan enrollees would be minimally impacted
because they often appeal claim or coverage denials for which they are
financially responsible, and for which we would use the existing AIC
calculation methodology. We note that this analysis is limited by the
use of only one fiscal year's worth of data, and that there is
uncertainty in this estimate as the number of appeals that would fall
under the revised AIC calculation may vary from year to year.
The Regulatory Flexibility Act (5 U.S.C. 601 et seq.) (RFA)
requires agencies to prepare an initial regulatory flexibility analysis
to describe the impact of the proposed rule on small entities, unless
the head of the agency can certify that the rule would not have a
significant economic impact on a substantial number of small entities.
The RFA generally defines a ``small entity'' as: (1) A proprietary firm
meeting the size standards of the Small Business Administration (SBA);
(2) a not-for-profit organization that is not dominant in its field; or
(3) a small government jurisdiction with a population of less than
50,000. States and individuals are not included in the definition of
``small entity.'' HHS uses as its measure of significant economic
impact on a substantial number of small entities a change in revenues
of more than 3 to 5 percent.
For purposes of the RFA, most providers and suppliers are small
entities, either by nonprofit status or by having revenues of less than
$7.5 million to $38.5 million in any one year. In addition, a number of
MAOs and Part D plan sponsors (insurers) are small entities due to
their nonprofit status; however, few if any meet the SBA size standard
for a small insurance firm by having revenues of $38.5 million or less
in any one year. Individuals and States are not included in the
definition of a small entity. We have determined and we certify that
this proposed rule would not have a significant economic impact on a
substantial number of small entities because as noted above, this
proposed rule if finalized would make only minimal changes to the
existing appeals procedures. Therefore, we are not preparing an
analysis for the RFA.
In addition, section 1102(b) of the Act requires us to prepare a
regulatory impact analysis (RIA) if a rule may have a significant
impact on the operations of a substantial number of small rural
hospitals. For proposed rules, this analysis must conform to the
provisions of section 603 of the RFA. For purposes of section 1102(b)
of the Act, we define a small rural hospital as a hospital that is
located outside of a Metropolitan Statistical Area for Medicare payment
regulations and has fewer than 100 beds. We have determined that this
proposed rule would not have a significant effect on the operations of
a substantial number of small rural hospitals. As noted above, this
proposed rule if finalized would make only minimal changes to the
existing appeals procedures and thus, would not have a significant
impact on small entities or the operations of a substantial number of
small rural hospitals. Therefore, we are not preparing an analysis for
section 1102(b) of the Act.
Section 202 of the Unfunded Mandates Reform Act of 1995 also
requires that agencies assess anticipated costs and benefits before
issuing any rule that would include any Federal mandate that may result
in expenditure in any one year by State, local, or Tribal governments,
in the aggregate, or by the private sector, of $100 million in 1995
dollars, updated annually for inflation. Currently, that threshold is
approximately $146 million. This proposed rule would not impose
spending costs on State, local, or tribal governments in the aggregate,
or on the private sector in the amount of $146 million in any one year,
because as
[[Page 43857]]
noted above, this proposed rule if finalized would make only minimal
changes to the existing appeals procedures.
VII. Federal Analysis
Executive Order 13132 on Federalism establishes certain
requirements that an agency must meet when it publishes a proposed rule
(and subsequent final rule) that imposes substantial direct requirement
costs on State and local governments, preempts State law, or otherwise
has Federalism implications. This proposed rule would not impose
substantial direct requirement costs on State or local governments,
preempt State law, or otherwise implicate federalism.
In accordance with the provisions of Executive Order 12866, this
regulation was reviewed by the Office of Management and Budget.
List of Subjects
42 CFR Part 401
Claims, Freedom of information, Health facilities, Medicare,
Privacy.
42 CFR Part 405
Administrative practice and procedure, Health facilities, Health
professions, Kidney diseases, Medical devices, Medicare, Reporting and
recordkeeping requirements, Rural areas, X-rays.
42 CFR Part 422
Administrative practice and procedure, Health facilities, Health
maintenance organizations (HMO), Medicare, Penalties, Privacy, and
Reporting and recordkeeping requirements.
42 CFR Part 423
Administrative practice and procedure, Emergency medical services,
Health facilities, Health maintenance organizations (HMO), Health
professionals, Medicare, Penalties, Privacy, Reporting and
recordkeeping requirements.
42 CFR Part 478
Administrative practice and procedure, Health care, Health
professions, Peer Review Organizations (PRO), Reporting and
recordkeeping requirements.
For the reasons set forth in the preamble, the Department of Health
and Human Services proposes to amend 42 CFR chapter IV as set forth
below:
PART 401--GENERAL ADMINISTRATIVE REQUIREMENTS
0
1. The authority citation for part 401 continues to read as follows:
Authority: Secs. 1102, 1871, and 1874(e) of the Social Security
Act (42 U.S.C. 1302, 1395hh, and 1395w-5).
0
2. Section 401.109 is added to read as follows:
Sec. 401.109 Precedential Final Decisions of the Secretary.
(a) The Chair of the Department of Health and Human Services
Departmental Appeals Board may designate a final decision of the
Secretary issued by the Medicare Appeals Council in accordance with
part 405, subpart I; part 422, subpart M; part 423, subpart U; or part
478, subpart B, of this chapter as precedential.
(b) Precedential decisions are made available to the public, with
personally identifiable information of the beneficiary removed, and
have precedential effect from the date they are made available to the
public. Notice of precedential decisions is published in the Federal
Register.
(c) Medicare Appeals Council decisions designated in accordance
with paragraph (a) of this section have precedential effect and are
binding on all CMS components, on all HHS components that adjudicate
matters under the jurisdiction of CMS, and on the Social Security
Administration to the extent that components of the Social Security
Administration adjudicate matters under the jurisdiction of CMS.
(d) Precedential effect, as used in this section, means that the
Medicare Appeals Council's--
(1) Legal analysis and interpretation of a Medicare authority or
provision is binding and must be followed in future determinations and
appeals in which the same authority or provision applies and is still
in effect; and
(2) Factual findings are binding and must be applied to future
determinations and appeals involving the same parties if the relevant
facts are the same and evidence is presented that the underlying
factual circumstances have not changed since the issuance of the
precedential final decision.
PART 405--FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED
0
3. The authority citation for part 405 continues to read as follows:
Authority: Secs. 205(a), 1102, 1861, 1862(a), 1869, 1871, 1874,
1881, and 1886(k) of the Social Security Act (42 U.S.C. 405(a),
1302, 1395x, 1395y(a), 1395ff, 1395hh, 1395kk, 1395rr and
1395ww(k)), and sec. 353 of the Public Health Service Act (42 U.S.C.
263a).
0
4. Section 405.902 is amended by adding the definitions of ``Attorney
Adjudicator'', ``Council'', and ``OMHA'' in alphabetical order and
removing the definition of ``MAC'' to read as follows:
Sec. 405.902 Definitions.
* * * * *
Attorney Adjudicator means a licensed attorney employed by OMHA
with knowledge of Medicare coverage and payment laws and guidance, and
authorized to take the actions provided for in this subpart on requests
for ALJ hearing and requests for reviews of QIC dismissals.
* * * * *
Council stands for the Medicare Appeals Council within the
Departmental Appeals Board of the U.S. Department of Health and Human
Services.
* * * * *
OMHA stands for the Office of Medicare Hearings and Appeals within
the U.S. Department of Health and Human Services, which administers the
ALJ hearing process in accordance with section 1869(b)(1) of the Act.
* * * * *
0
5. Section 405.904 is amended by revising paragraphs (a)(1) and (2) to
read as follows:
Sec. 405.904 Medicare initial determinations, redeterminations and
appeals: General description.
(a) * * *
(1) Entitlement appeals. The SSA makes an initial determination on
an application for Medicare benefits and/or entitlement of an
individual to receive Medicare benefits. A beneficiary who is
dissatisfied with the initial determination may request, and SSA will
perform, a reconsideration in accordance with 20 CFR part 404, subpart
J if the requirements for obtaining a reconsideration are met.
Following the reconsideration, the beneficiary may request a hearing
before an Administrative Law Judge (ALJ) under this subpart (42 CFR
part 405, subpart I). If the beneficiary obtains a hearing before an
ALJ and is dissatisfied with the decision of the ALJ, or if the
beneficiary requests a hearing and no hearing is conducted, and the
beneficiary is dissatisfied with the decision of an ALJ or an attorney
adjudicator, he or she may request the Medicare Appeals Council
(Council) to review the case. Following the action of the Council, the
beneficiary may be entitled to file suit in Federal district court.
[[Page 43858]]
(2) Claim appeals. The Medicare contractor makes an initial
determination when a claim for Medicare benefits under Part A or Part B
is submitted. A beneficiary who is dissatisfied with the initial
determination may request that the contractor perform a redetermination
of the claim if the requirements for obtaining a redetermination are
met. Following the contractor's redetermination, the beneficiary may
request, and the Qualified Independent Contractor (QIC) will perform, a
reconsideration of the claim if the requirements for obtaining a
reconsideration are met. Following the reconsideration, the beneficiary
may request a hearing before an ALJ. If the beneficiary obtains a
hearing before the ALJ and is dissatisfied with the decision of the
ALJ, or if the beneficiary requests a hearing and no hearing is
conducted, and the beneficiary is dissatisfied with the decision of an
ALJ or attorney adjudicator, he or she may request the Council to
review the case. If the Council reviews the case and issues a decision,
and the beneficiary is dissatisfied with the decision, the beneficiary
may file suit in Federal district court if the amount remaining in
controversy and the other requirements for judicial review are met.
* * * * *
Sec. 405.906 [Amended]
0
6. Section 405.906(b) introductory text is amended by--
0
a. Removing from the paragraph heading the phrase ``hearing and MAC''
and adding ``proceedings on a request for hearing, and Council review''
in its place.
0
b. Removing the phrase ``hearing, and MAC review'' and adding
``proceedings on a request for hearing, and Council review'' in its
place.
Sec. 405.908 [Amended]
0
7. Section 405.908 is amended by--
0
a. Removing the term ``ALJ'' and adding ``OMHA'' in its place.
0
b. Removing the term ``MAC'' and adding ``Council'' in its place.
0
8. Section 405.910 is amended by--
0
a. Revising paragraph (c)(5).
0
b. Adding paragraph (d)(3).
0
c. Revising paragraphs (f)(1), (i)(2), and (3).
0
d. Revising paragraph (l).
0
e. Adding paragraph (m)(4).
The additions and revisions read as follows:
Sec. 405.910 Appointed representatives.
* * * * *
(c) * * *
(5) Identify the beneficiary's Medicare health insurance claim
number when the beneficiary is the party appointing a representative,
or identify the Medicare National Provider Identifier number of the
provider or supplier that furnished the item or service when the
provider or supplier is the party appointing a representative;
* * * * *
(d) * * *
(3) If an adjudication time frame applies, the time from the later
of the date that a defective appointment of representative was filed or
the current appeal request was filed by the prospective appointed
representative, to the date when the defect was cured or the party
notifies the adjudicator that he or she will proceed with the appeal
without a representative does not count towards the adjudication time
frame.
* * * * *
(f) * * *
(1) General rule. An appointed representative for a beneficiary who
wishes to charge a fee for services rendered in connection with an
appeal before the Secretary must obtain approval of the fee from the
Secretary. Services rendered below the OMHA level are not considered
proceedings before the Secretary.
* * * * *
(i) * * *
(2) Appeals. When a contractor, QIC, ALJ or attorney adjudicator,
or the Council takes an action or issues a redetermination,
reconsideration, or appeal decision, in connection with an initial
determination, it sends notice of the action to the appointed
representative.
(3) The contractor, QIC, ALJ or attorney adjudicator, or Council
sends any requests for information or evidence regarding a claim that
is appealed to the appointed representative. The contractor sends any
requests for information or evidence regarding an initial determination
to the party.
* * * * *
(l) Delegation of appointment by appointed representative. (1) An
appointed representative may not designate another individual to act as
the appointed representative of the party unless--
(i) The appointed representative provides written notice to the
party of the appointed representative's intent to delegate to another
individual, which contains the name of the designee and the designee's
acceptance to be obligated by and comply with the requirements of
representation under this subpart; and
(ii) The party accepts the designation as evidenced by a written
statement signed by the party. The written statement signed by the
party is not required when the appointed representative and designee
are attorneys in the same law firm or organization and the notice
described in paragraph (l)(1)(i) of this section so indicates.
(2) A delegation is not effective until the adjudicator receives a
copy of the acceptance described in paragraph (l)(1)(ii) of this
section, unless the appointed representative and designee are attorneys
in the same law firm or organization, in which case the notice
described in paragraph (l)(1)(i) of this section may be submitted even
though the acceptance described in paragraph (l)(1)(ii) of this section
is not required.
(3) A party's or representative's failure to notify the adjudicator
that an appointment of representative has been delegated is not good
cause for missing a deadline or not appearing at a hearing.
(m) * * *
(4) A party's or representative's failure to notify the adjudicator
that an appointment of representative has been revoked is not good
cause for missing a deadline or not appearing at a hearing.
0
9. Section 405.926 is amended by revising paragraphs (l) and (m) to
read as follows:
Sec. 405.926 Actions that are not initial determinations.
* * * * *
(l) A contractor's, QIC's, ALJ's or attorney adjudicator's, or
Council's determination or decision to reopen or not to reopen an
initial determination, redetermination, reconsideration, decision, or
review decision.
(m) Determinations that CMS or its contractors may participate in
the proceedings on a request for an ALJ hearing or act as parties in an
ALJ hearing or Council review.
* * * * *
Sec. 405.956 [Amended]
0
10. Section 405.956(b)(8) is amended by removing the phrase ``an ALJ
hearing'' and adding ``the OMHA level'' in its place.
0
11. Section 405.968 is amended by revising paragraph (b)(1) to read as
follows:
Sec. 405.968 Conduct of a reconsideration.
* * * * *
(b) * * *
(1) National coverage determinations (NCDs), CMS Rulings, Council
decisions designated by the Chair of the Departmental Appeals Board as
having precedential effect under Sec. 401.109 of this chapter, and
applicable laws and regulations are binding on the QIC.
* * * * *
[[Page 43859]]
0
12. Section 405.970 is amended by revising the section heading and
paragraphs (a) introductory text, (b), (c) introductory text, (e)(1),
(e)(2)(i) and (ii) to read as follows:
Sec. 405.970 Timeframe for making a reconsideration following a
contractor redetermination.
(a) General rule. Within 60 calendar days of the date the QIC
receives a timely filed request for reconsideration following a
contractor redetermination or any additional time provided by paragraph
(b) of this section, the QIC mails, or otherwise transmits to the
parties at their last known addresses, written notice of--
* * * * *
(b) Exceptions. (1) If a QIC grants an appellant's request for an
extension of the 180 calendar day filing deadline made in accordance
with Sec. 405.962(b), the QIC's 60 calendar day decision-making
timeframe begins on the date the QIC receives the late filed request
for reconsideration following a contractor redetermination, or when the
request for an extension that meets the requirements of Sec.
405.962(b) is granted, whichever is later.
(2) If a QIC receives timely requests for reconsideration following
a contractor redetermination from multiple parties, consistent with
Sec. 405.964(c), the QIC must issue a reconsideration, notice that it
cannot complete its review, or dismissal within 60 calendar days for
each submission of the latest filed request.
(3) Each time a party submits additional evidence after the request
for reconsideration following a contractor redetermination is filed,
the QIC's 60 calendar day decisionmaking timeframe is extended by up to
14 calendar days for each submission, consistent with Sec. 405.966(b).
(c) Responsibilities of the QIC. Within 60 calendar days of
receiving a request for a reconsideration following a contractor
redetermination, or any additional time provided for under paragraph
(b) of this section, a QIC must take one of the following actions:
* * * * *
(e) * * *
(1) If the appellant fails to notify the QIC, or notifies the QIC
that the appellant does not choose to escalate the case, the QIC
completes its reconsideration following a contractor redetermination
and notifies the appellant of its action consistent with Sec. 405.972
or Sec. 405.976.
(2) * * *
(i) Complete its reconsideration following a contractor
redetermination and notify all parties of its decision consistent with
Sec. 405.972 or Sec. 405.976.
(ii) Acknowledge the escalation notice in writing and forward the
case file to OMHA.
0
13. Section 405.972 is amended by--
0
a. Revising the section heading.
0
b. Amending paragraph (b)(3) by removing the phrase ``reconsideration
of a contractor's dismissal'' and adding ``review of a contractor's
dismissal'' in its place.
0
c. Amending paragraph (e) by adding the phrase ``or attorney
adjudicator'' after the phrase ``modified or reversed by an ALJ'' and
removing the phrase ``reconsideration of a contractor's dismissal'' and
adding ``review of a contractor's dismissal'' in its place.
The revision reads as follows:
Sec. 405.972 Withdrawal or dismissal of a request for reconsideration
or review of a contractor's dismissal of a request for redetermination.
* * * * *
0
14. Section 405.974 is amended by--
0
a. Revising the section heading.
0
b. Amending the heading to paragraph (b) by removing the phrase
``Reconsideration of contractor's'' and adding ``Review of a
contractor's'' in its place.
0
c. Amending paragraph (b)(3) by removing the word ``reconsideration''
and adding ``review'' in its place.
The revision reads as follows:
Sec. 405.974 Reconsideration and review of a contractor's dismissal
of a request for redetermination.
* * * * *
0
15. Section 405.976 is amended by--
0
a. Amending paragraph (b)(5)(ii) by removing the phrase ``at an ALJ
level, or made part of the administrative record'' and adding ``at the
OMHA level'' in its place.
0
b. Revising paragraph (b)(7) to read as follows:
Sec. 405.976 Notice of a reconsideration.
* * * * *
(b) * * *
(7) A statement of whether the amount in controversy is estimated
to meet or not meet the amount required for an ALJ hearing, if--
(i) The request for reconsideration was filed by a beneficiary who
is not represented by a provider, supplier, or Medicaid State agency;
and
(ii) The reconsideration decision is partially or fully
unfavorable.
* * * * *
Sec. 405.978 [Amended]
0
16. Section 405.978(a) is amended by removing the phrase ``An ALJ
decision'' and adding ``An ALJ or attorney adjudicator decision'' in
its place.
0
17. Section 405.980 is amended by revising the section heading and
paragraphs (a)(1)(iii) and (iv), (a)(4) and (5), (d) paragraph heading,
(d)(2) and (3), (e) paragraph heading, and (e)(2) and (3) to read as
follows:
Sec. 405.980 Reopening of initial determinations, redeterminations,
reconsiderations, decisions, and reviews.
(a) * * *
(1) * * *
(iii) An ALJ or attorney adjudicator to revise his or her decision;
or
(iv) The Council to revise the ALJ or attorney adjudicator
decision, or its review decision.
* * * * *
(4) When a party has filed a valid request for an appeal of an
initial determination, redetermination, reconsideration, ALJ or
attorney adjudicator decision, or Council review, no adjudicator has
jurisdiction to reopen an issue on a claim that is under appeal until
all appeal rights for that issue are exhausted. Once the appeal rights
for the issue have been exhausted, the contractor, QIC, ALJ or attorney
adjudicator, or Council may reopen as set forth in this section.
(5) The contractor's, QIC's, ALJ's or attorney adjudicator's, or
Council's decision on whether to reopen is binding and not subject to
appeal.
* * * * *
(d) Time frame and requirements for reopening reconsiderations,
decisions and reviews initiated by a QIC, ALJ or attorney adjudicator,
or the Council.
* * * * *
(2) An ALJ or attorney adjudicator may reopen his or her decision,
or the Council may reopen an ALJ or attorney adjudicator decision on
its own motion within 180 calendar days from the date of the decision
for good cause in accordance with Sec. 405.986. If the decision was
procured by fraud or similar fault, then the ALJ or attorney
adjudicator may reopen his or her decision, or the Council may reopen
an ALJ or attorney adjudicator decision, at any time.
(3) The Council may reopen its review decision on its own motion
within 180 calendar days from the date of the review decision for good
cause in accordance with Sec. 405.986. If the Council's decision was
procured by fraud or similar fault, then the Council may reopen at any
time.
(e) Time frames and requirements for reopening reconsiderations,
decisions, and reviews requested by a party.
* * * * *
[[Page 43860]]
(2) A party to an ALJ or attorney adjudicator decision may request
that an ALJ or attorney adjudicator reopen his or her decision, or the
Council reopen an ALJ or attorney adjudicator decision, within 180
calendar days from the date of the decision for good cause in
accordance with Sec. 405.986.
(3) A party to a Council review may request that the Council reopen
its decision within 180 calendar days from the date of the review
decision for good cause in accordance with Sec. 405.986.
Sec. 405.982 [Amended]
0
18. Section 405.982(a) and (b) are amended by removing the phrase
``ALJ, or the MAC'' and adding the phrase ``ALJ or attorney
adjudicator, or the Council'' in its place.
0
19. Section 405.984 is amended by--
0
a. Amending paragraph (c) by removing the phrase ``in accordance with
Sec. 405.1000 through Sec. 405.1064'' and adding ``in accordance with
Sec. 405.1000 through Sec. 405.1063'' in its place.
0
b. Revising paragraphs (d) and (e) to read as follows:
Sec. 405.984 Effect of a revised determination or decision.
* * * * *
(d) ALJ or attorney adjudicator decisions. The revision of an ALJ
or attorney adjudicator decision is binding upon all parties unless a
party files a written request for a Council review that is accepted and
processed in accordance with Sec. 405.1100 through Sec. 405.1130.
(e) Council review. The revision of a Council review is binding
upon all parties unless a party files a civil action in which a Federal
district court accepts jurisdiction and issues a decision.
* * * * *
0
20. Section 405.990 is amended by--
0
a. Amending paragraph (a)(2) by removing the phrase ``Medicare Appeals
Council (MAC)'' and adding the term ``Council'' in its place.
0
b. Amending paragraphs (b)(1) introductory text, (b)(1)(i)(B), (b)(4),
and (d)(2)(ii) by removing the term ``MAC'' each time it appears and
adding ``Council'' in its place.
0
c. Amending paragraph (b)(1)(i)(A) by removing the phrase ``the ALJ
has'' and adding ``the ALJ or attorney adjudicator has'' in its place.
0
d. Amending paragraph (b)(1)(ii) by removing the phrase ``to the ALJ
level'' and adding ``to OMHA for an ALJ hearing'' in its place.
0
e. Amending paragraphs (c)(3), (4), and (5) by removing the term ``ALJ
hearing decision'' and adding ``ALJ or attorney adjudicator decision''
in its place.
0
h. Revising paragraph (d)(1).
0
i. Amending paragraph (d)(2)(i) by removing the term ``ALJ's'' and
adding ``ALJ's or attorney adjudicator's'' in its place.
0
j. Amending paragraph (d)(2)(ii) by removing the term ``MAC's'' and
adding ``Council's'' in its place.
0
k. Revising paragraphs (i)(1) and (2).
The revisions read as follows:
Sec. 405.990 Expedited access to judicial review.
* * * * *
(d) * * *
(1) Method and place for filing request. The requestor may--
(i) If a request for ALJ hearing or Council review is not pending,
file a written EAJR request with the HHS Departmental Appeals Board
with his or her request for an ALJ hearing or Council review; or
(ii) If an appeal is already pending for an ALJ hearing or
otherwise before OMHA, or the Council, file a written EAJR request with
the HHS Departmental Appeals Board.
* * * * *
(i) * * *
(1) If a request for EAJR does not meet all the conditions set out
in paragraphs (b), (c) and (d) of this section, or if the review entity
does not certify a request for EAJR, the review entity advises in
writing all parties that the request has been denied, and forwards the
request to OMHA or the Council, which will treat it as a request for
hearing or for Council review, as appropriate.
(2) Whenever a review entity forwards a rejected EAJR request to
OMHA or the Council, the appeal is considered timely filed, and if an
adjudication time frame applies to the appeal, the adjudication time
frame begins on the day the request is received by OMHA or the Council
from the review entity.
* * * * *
0
21. Section 405.1000 is revised to read as follows:
Sec. 405.1000 Hearing before an ALJ and decision by an ALJ or
attorney adjudicator: General rule.
(a) If a party is dissatisfied with a QIC's reconsideration, or if
the adjudication period specified in Sec. 405.970 for the QIC to
complete its reconsideration has elapsed, the party may request a
hearing before an ALJ.
(b) A hearing before an ALJ may be conducted in-person, by video-
teleconference (VTC), or by telephone. At the hearing, the parties may
submit evidence (subject to the restrictions in Sec. 405.1018 and
Sec. 405.1028), examine the evidence used in making the determination
under review, and present and/or question witnesses.
(c) In some circumstances, CMS or its contractor may participate in
the proceedings under Sec. 405.1010, or join the hearing before an ALJ
as a party under Sec. 405.1012.
(d) The ALJ or attorney adjudicator conducts a de novo review and
issues a decision based on the administrative record, including, for an
ALJ, any hearing record.
(e) If all parties who are due a notice of hearing in accordance
with Sec. 405.1020(c) waive their right to appear at the hearing in
person or by telephone or video-teleconference, the ALJ or an attorney
adjudicator may make a decision based on the evidence that is in the
file and any new evidence that is submitted for consideration.
(f) The ALJ may require the parties to participate in a hearing if
it is necessary to decide the case. If the ALJ determines that it is
necessary to obtain testimony from a non-party, he or she may hold a
hearing to obtain that testimony, even if all of the parties who are
entitled to a notice of hearing in accordance with Sec. 405.1020(c)
have waived the right to appear. In that event, however, the ALJ will
give the parties the opportunity to appear when the testimony is given,
but may hold the hearing even if none of the parties decide to appear.
(g) An ALJ or attorney adjudicator may also issue a decision on the
record on his or her own initiative if the evidence in the
administrative record supports a fully favorable finding for the
appellant, and there is no other party or no other party is entitled to
a notice of hearing in accordance with Sec. 405.1020(c).
(h) If more than one party timely files a request for hearing on
the same claim before a decision is made on the first timely filed
request, the requests are consolidated into one proceeding and record,
and one decision, dismissal, or remand is issued.
Sec. 405.1002 [Amended]
0
22. Section 405.1002 is amended by--
0
a. Amending paragraph (a) introductory text by removing the phrase
``may request'' and adding ``has a right to'' in its place
0
b. Amending paragraph (a)(4) by removing the word ``entity'' and adding
``office'' in its place.
0
c. Amending paragraph (b)(1) by removing the phrase ``to the ALJ
level'' and adding ``for a hearing before an ALJ'' in its place.
0
23. Section 405.1004 is amended by--
0
a. Revising the section heading and paragraphs (a) introductory text,
(a)(1) and (4), (b), and (c).
0
b. Adding paragraph (d).
The revisions and addition read as follows:
[[Page 43861]]
Sec. 405.1004 Right to a review of QIC notice of dismissal.
(a) A party to a QIC's dismissal of a request for reconsideration
has a right to have the dismissal reviewed by an ALJ or attorney
adjudicator if--
(1) The party files a written request for review within 60 calendar
days after receipt of the notice of the QIC's dismissal.
* * * * *
(4) For purposes of meeting the 60 calendar day filing deadline,
the request is considered as filed on the date it is received by the
office specified in the QIC's dismissal.
(b) If the ALJ or attorney adjudicator determines that the QIC's
dismissal was in error, he or she vacates the dismissal and remands the
case to the QIC for a reconsideration in accordance with Sec.
405.1056.
(c) If the ALJ or attorney adjudicator affirms the QIC's dismissal
of a reconsideration request, he or she issues a notice of decision
affirming the QIC dismissal in accordance with Sec. 405.1046(b).
(d) The ALJ or attorney adjudicator may dismiss the request for
review of a QIC's dismissal in accordance with Sec. 405.1052(b).
0
24. Section 405.1006 is amended by--
0
a. Revising the section heading and paragraphs (d)(1) introductory
text, (d)(1)(ii), and (d)(2).
0
b. Adding paragraphs (d)(3) through (7).
0
c. Revising paragraphs (e)(1) introductory text, (e)(1)(ii) and (iii),
(e)(2) introductory text, and (e)(2)(ii) and (iii).
The revisions and additions read as follows:
Sec. 405.1006 Amount in controversy required for an ALJ hearing and
judicial review.
* * * * *
(d) * * *
(1) In general. In situations other than those described in
paragraphs (d)(3) through (7) of this section, the amount remaining in
controversy is computed as the basis for the amount in controversy for
the items and services in the disputed claim, as defined in paragraph
(d)(2) of this section, reduced by--
* * * * *
(ii) Any deductible and/or coinsurance amounts that may be
collected for the items or services.
(2) Basis for the amount in controversy. For purposes of
calculating the amount in controversy under paragraph (d)(1) of this
section, the basis for the amount in controversy is defined as follows:
(i) General rule. For situations other than those described in
paragraphs (d)(2)(ii) and (iii) of this section, the basis for the
amount in controversy is determined as follows:
(A) For items and services with a published Medicare fee schedule
or published contractor-priced amount, the basis for the amount in
controversy is the allowable amount, which is the amount reflected on
the fee schedule or in the contractor-priced amount for those items or
services in the applicable jurisdiction and place of service.
(B) For items and services with no published Medicare fee schedule
or published contractor-priced amount, the basis for the amount in
controversy is the billed charges submitted on the claim for those
items or services.
(ii) Beneficiary financial responsibility. For items and services
for which a beneficiary has been determined to be financially
responsible, the basis for the amount in controversy is the actual
amount charged to the beneficiary (or the maximum amount the
beneficiary may be charged if no bill has been received) for the items
and services in the disputed claim.
(iii) Refunds of amounts previously collected. If a beneficiary
received or may be entitled to a refund of the amount the beneficiary
previously paid to the provider or supplier for the items or services
in the disputed claim under applicable statutory or regulatory
authority, the basis for the amount in controversy is the actual amount
originally charged to the beneficiary for those items or services.
(3) Limitation on liability. When payment is made for items or
services under section 1879 of the Act or Sec. 411.400 of this
chapter, or the liability of the beneficiary for those services is
limited under Sec. 411.402 of this chapter, the amount in controversy
is calculated in accordance with paragraphs (d)(1) and (d)(2)(i) of
this section, except there is no deduction under paragraph (d)(1)(i)
for expenses that are paid under Sec. 411.400 of this chapter or as a
result of liability that is limited under Sec. 411.402 of this
chapter.
(4) Item or service terminations. When a matter involves a provider
or supplier termination of Medicare-covered items or services that is
disputed by a beneficiary, and the beneficiary did not elect to
continue receiving the items or services, the amount in controversy is
calculated in accordance with paragraphs (d)(1) and (d)(2)(ii) of this
section, except that the basis for the amount in controversy and any
deductible and coinsurance that may be collected for the items or
services are calculated using the amount the beneficiary would have
been charged if the beneficiary had received the items or services the
beneficiary asserts should have been covered based on the beneficiary's
current condition, and Medicare payment were not made for the items or
services.
(5) Overpayments. Notwithstanding paragraphs (d)(1) and (2) of this
section, when an appeal involves an identified overpayment, the amount
in controversy is the amount of the overpayment specified in the demand
letter for the items or services in the disputed claim. When an appeal
involves an estimated overpayment amount determined through the use of
statistical sampling and extrapolation, the amount in controversy is
the total amount of the estimated overpayment determined through
extrapolation, as specified in the demand letter.
(6) Coinsurance and deductible challenges. Notwithstanding
paragraphs (d)(1) and (2) of this section, for appeals filed by
beneficiaries challenging only the computation of a coinsurance amount
or the amount of a remaining deductible, the amount in controversy is
the difference between the amount of the coinsurance or remaining
deductible, as determined by the contractor, and the amount of the
coinsurance or remaining deductible the beneficiary believes is
correct.
(7) Fee schedule or contractor price challenges. Notwithstanding
paragraphs (d)(1) and (2) of this section, for appeals of claims where
the allowable amount has been paid in full and the appellant is
challenging only the validity of the allowable amount, as reflected on
the published fee schedule or in the published contractor-priced amount
applicable to the items or services in the disputed claim, the amount
in controversy is the difference between the amount the appellant
argues should have been the allowable amount for the items or services
in the disputed claim in the applicable jurisdiction and place of
service, and the published allowable amount for the items or services.
(e) * * *
(1) Aggregating claims in appeals of QIC reconsiderations for an
ALJ hearing. Either an individual appellant or multiple appellants may
aggregate two or more claims to meet the amount in controversy for an
ALJ hearing if--
* * * * *
(ii) The appellant(s) requests aggregation of claims appealed in
the same request for ALJ hearing, or in multiple requests for an ALJ
hearing filed with the same request for aggregation, and the request is
filed
[[Page 43862]]
within 60 calendar days after receipt of all of the reconsiderations
being appealed; and
(iii) The claims that a single appellant seeks to aggregate involve
the delivery of similar or related services, or the claims that
multiple appellants seek to aggregate involve common issues of law and
fact, as determined by an ALJ or attorney adjudicator. Only an ALJ may
determine the claims that a single appellant seeks to aggregate do not
involve the delivery of similar or related services, or the claims that
multiple appellants seek to aggregate do not involve common issues of
law and fact. Part A and Part B claims may be combined to meet the
amount in controversy requirements.
(2) Aggregating claims that are escalated from the QIC level for an
ALJ hearing. Either an individual appellant or multiple appellants may
aggregate two or more claims to meet the amount in controversy for an
ALJ hearing if--
* * * * *
(ii) The appellant(s) requests aggregation of the claims for an ALJ
hearing in the same request for escalation; and
(iii) The claims that a single appellant seeks to aggregate involve
the delivery of similar or related services, or the claims that
multiple appellants seek to aggregate involve common issues of law and
fact, as determined by an ALJ or attorney adjudicator. Only an ALJ may
determine the claims that a single appellant seeks to aggregate do not
involve the delivery of similar or related services, or the claims that
multiple appellants seek to aggregate do not involve common issues of
law and fact. Part A and Part B claims may be combined to meet the
amount in controversy requirements.
* * * * *
0
25. Section 405.1008 is revised to read as follows:
Sec. 405.1008 Parties to the proceedings on a request for an ALJ
hearing.
The party who filed the request for hearing and all other parties
to the reconsideration are parties to the proceedings on a request for
an ALJ hearing. In addition, a representative of CMS or its contractor
may be a party under the circumstances described in Sec. 405.1012.
0
26. Section 405.1010 is revised to read as follows:
Sec. 405.1010 When CMS or its contractors may participate in the
proceedings on a request for an ALJ hearing.
(a) When CMS or a contractor can participate. (1) CMS or its
contractors may elect to participate in the proceedings on a request
for an ALJ hearing upon filing a notice of intent to participate in
accordance with paragraph (b) of this section.
(2) An ALJ may request, but may not require, CMS and/or one or more
of its contractors to participate in any proceedings before the ALJ,
including the oral hearing, if any. The ALJ cannot draw any adverse
inferences if CMS or the contractor decides not to participate in any
proceedings before the ALJ, including the hearing.
(b) How an election is made. (1) No notice of hearing. If CMS or a
contractor elects to participate before receipt of a notice of hearing,
or when a notice of hearing is not required, it must send written
notice of its intent to participate to the assigned ALJ or attorney
adjudicator, or a designee of the Chief ALJ if the request for hearing
is not yet assigned to an ALJ or attorney adjudicator, and the parties
who were sent a copy of the notice of reconsideration.
(2) Notice of hearing. If CMS or a contractor elects to participate
after receipt of a notice of hearing, it must send written notice of
its intent to participate to the ALJ and the parties who were sent a
copy of the notice of hearing.
(3) Timing of election. CMS or a contractor must send its notice of
intent to participate--
(i) If no hearing is scheduled, no later than 30 calendar days
after notification that a request for hearing was filed; or
(ii) If a hearing is scheduled, no later than 10 calendar days
after receiving the notice of hearing.
(c) Roles and responsibilities of CMS or a contractor as a
participant. (1) Subject to paragraphs (d)(1) through (d)(3) of this
section, participation may include filing position papers and/or
providing testimony to clarify factual or policy issues in a case, but
it does not include calling witnesses or cross-examining the witnesses
of a party to the hearing.
(2) When CMS or its contractor participates in an ALJ hearing, CMS
or its contractor may not be called as a witness during the hearing and
is not subject to examination or cross-examination by the parties.
However, the parties may provide testimony to rebut factual or policy
statements made by a participant and the ALJ may question the
participant about its testimony.
(3) CMS or contractor position papers and written testimony are
subject to the following:
(i) A position paper or written testimony must be submitted by
within 14 calendar days of an election to participate if no hearing has
been scheduled, or no later than 5 calendar days prior to the hearing
if a hearing is scheduled unless the ALJ grants additional time to
submit the position paper or written testimony.
(ii) A copy of any position paper or written testimony it submits
to OMHA must be sent to--
(A) The parties who were sent a copy of the notice of
reconsideration, if the position paper or written testimony is being
submitted before receipt of a notice of hearing for the appeal; or
(B) The parties who were sent a copy of the notice of hearing, if
the position paper or written testimony is being submitted after
receipt of a notice of hearing for the appeal.
(iii) If CMS or a contractor fails to send a copy of its position
paper or written testimony to the parties or fails to submit its
position paper or written testimony within the time frames described in
this paragraph, the position paper or written testimony will not be
considered in deciding the appeal.
(d) Limitation on participating in a hearing. (1) If CMS or a
contractor has been made a party to a hearing in accordance with Sec.
405.1012, no entity that elected to be a participant in the proceedings
in accordance with this section (or that elected to be a party to the
hearing but was made a participant in accordance with Sec.
405.1012(d)(1)) may participate in the oral hearing, but such entity
may file a position paper and/or written testimony to clarify factual
or policy issues in the case.
(2) If CMS or a contractor did not elect to be a party to a hearing
in accordance with Sec. 405.1012 and more than one entity elected to
be a participant in the proceedings in accordance with this section,
only the first entity to file a response to the notice of hearing as
provided under Sec. 405.1020(c) may participate in the oral hearing.
Entities that filed a subsequent response to the notice of hearing may
not participate in the oral hearing, but may file a position paper and/
or written testimony to clarify factual or policy issues in the case.
(3) If CMS or a contractor is precluded from participating in the
oral hearing under paragraph (d)(1) or (2) of this section, the ALJ may
grant leave to the precluded entity to participate in the oral hearing
if the ALJ determines that the entity's participation is necessary for
a full examination of the matters at issue.
(e) Invalid election. (1) An ALJ or attorney adjudicator may
determine that a CMS or contractor election is invalid under this
section if the election was
[[Page 43863]]
not timely filed or the election was not sent to the correct parties.
(2) If an election is determined to be invalid, a written notice
must be sent to the entity that submitted the election and the parties
who are entitled to receive notice of the election in accordance with
this section.
(i) If no hearing is scheduled or the election was submitted after
the hearing occurred, the written notice of invalid election must be
sent no later than the date the notice of decision, dismissal, or
remand is mailed.
(ii) If a hearing is scheduled, the written notice of invalid
election must be sent prior to the hearing. If the notice would be sent
fewer than 5 calendar days before the hearing is scheduled to occur,
oral notice must be provided to the entity that submitted the election,
and the written notice must be sent as soon as possible after the oral
notice is provided.
0
27. Section 405.1012 is revised to read as follows:
* * * * *
Sec. 405.1012 When CMS or its contractors may be a party to a
hearing.
(a) When CMS or a contractor can elect to be a party to a hearing.
(1) Unless the request for hearing is filed by an unrepresented
beneficiary, and unless otherwise provided in this section, CMS or one
of its contractors may elect to be a party to the hearing upon filing a
notice of intent to be a party to the hearing in accordance with
paragraph (b) of this section no later than 10 calendar days after the
QIC receives the notice of hearing.
(2) An ALJ may request, but may not require, CMS and/or one or more
of its contractors to be a party to the hearing. The ALJ cannot draw
any adverse inferences if CMS or the contractor decides not to be a
party to the hearing.
(b) How an election is made. If CMS or a contractor elects to be a
party to the hearing, it must send written notice to the ALJ and the
parties identified in the notice of hearing of its intent to be a party
to the hearing.
(c) Roles and responsibilities of CMS or a contractor as a party.
(1) As a party, CMS or a contractor may file position papers, submit
evidence, provide testimony to clarify factual or policy issues, call
witnesses or cross-examine the witnesses of other parties.
(2) CMS or contractor position papers, written testimony, and
evidentiary submissions are subject to the following:
(i) Any position paper, written testimony, and/or evidence must be
submitted no later than 5 calendar days prior to the hearing unless the
ALJ grants additional time to submit the position paper, written
testimony, and/or evidence.
(ii) A copy of any position paper, written testimony, and/or
evidence it submits to OMHA must be sent to the parties who were sent a
copy of the notice of hearing.
(iii) If CMS or a contractor fails to send a copy of its position
paper, written testimony, and/or evidence to the parties or fails to
submit its position paper, written testimony, and/or evidence within
the time frames described in this section, the position paper, written
testimony, and/or evidence will not be considered in deciding the
appeal.
(d) Limitation on participating in a hearing. (1) If CMS and one or
more contractors, or multiple contractors, file an election to be a
party to the hearing, the first entity to file its election after the
notice of hearing is issued is made a party to the hearing and the
other entities are made participants in the proceedings under Sec.
405.1010, subject to Sec. 405.1010(d)(1) and (3), unless the ALJ
grants leave to an entity to also be a party to the hearing in
accordance with paragraph (d)(2) of this section.
(2) If CMS or a contractor filed an election to be a party in
accordance with this section but is precluded from being made a party
under paragraph (d)(1) of this section, the ALJ may grant leave to be a
party to the hearing if the ALJ determines that the entity's
participation as a party is necessary for a full examination of the
matters at issue.
(e) Invalid election. (1) An ALJ or attorney adjudicator may
determine that a CMS or contractor election is invalid under this
section if the request for hearing was filed by an unrepresented
beneficiary, the election was not timely, the election was not sent to
the correct parties, or CMS or a contractor had already filed an
election to be a party to the hearing and the ALJ did not determine
that the entity's participation as a party is necessary for a full
examination of the matters at issue.
(2) If an election is determined to be invalid, a written notice
must be sent to the entity that submitted the election and the parties
who were sent the notice of hearing.
(i) If the election was submitted after the hearing occurred, the
written notice of invalid election must be sent no later than the date
the decision, dismissal, or remand notice is mailed.
(ii) If the election was submitted before the hearing occurs, the
written notice of invalid election must be sent prior to the hearing.
If the notice would be sent fewer than 5 calendar days before the
hearing is scheduled to occur, oral notice must be provided to the
entity that submitted the election, and the written notice to the
entity and the parties who were sent the notice of hearing must be sent
as soon as possible after the oral notice is provided.
0
28. Section 405.1014 is revised to read as follows:
Sec. 405.1014 Request for an ALJ hearing or a review of a QIC
dismissal.
(a) Content of the request. (1) The request for an ALJ hearing or a
review of a QIC dismissal must be made in writing. The request must
include all of the following--
(i) The name, address, and Medicare health insurance claim number
of the beneficiary whose claim is being appealed, and the beneficiary's
telephone number if the beneficiary is the appealing party and not
represented.
(ii) The name, address, and telephone number, of the appellant,
when the appellant is not the beneficiary.
(iii) The name, address, and telephone number, of the designated
representative, if any.
(iv) The Medicare appeal number or document control number, if any,
assigned to the QIC reconsideration or dismissal notice being appealed.
(v) The dates of service of the claim(s) being appealed, if
applicable.
(vi) The reasons the appellant disagrees with the QIC's
reconsideration or other determination being appealed.
(vii) A statement of whether the filing party is aware that it or
the claim is the subject of an investigation or proceeding by the HHS
Office of Inspector General or other law enforcement agencies.
(viii) For requests filed by providers, suppliers, Medicaid State
agencies, applicable plans, or a beneficiary who is represented by a
provider, supplier or Medicaid State agency, the amount in controversy
applicable to the disputed claim determined in accordance with Sec.
405.1006, unless the matter involves a provider or supplier termination
of Medicare-covered items or services that is disputed by a
beneficiary, and the beneficiary did not elect to continue receiving
the items or services.
(2) The appellant must submit a statement of any additional
evidence to be submitted and the date it will be submitted.
(3) Special rule for appealing statistical sample and/or
extrapolation. If the appellant disagrees with how a statistical sample
and/or extrapolation was conducted, the appellant must--
(i) Include the information in paragraphs (a)(1) and (2) of this
section for each sample claim that the appellant wishes to appeal;
(ii) File the request for hearing for all sampled claims that the
appellant
[[Page 43864]]
wishes to appeal within 60 calendar days of the date the party receives
the last reconsideration for the sample claims, if they were not all
addressed in a single reconsideration; and
(iii) Assert the reasons the appellant disagrees with how the
statistical sample and/or extrapolation was conducted in the request
for hearing.
(b) Complete request required. (1) A request must contain the
information in paragraph (a)(1) of this section to the extent the
information is applicable, to be considered complete. If a request is
not complete, the appellant will be provided with an opportunity to
complete the request, and if an adjudication time frame applies, it
does not begin until the request is complete. If the appellant fails to
provide the information necessary to complete the request within the
time frame provided, the appellant's request for hearing or review will
be dismissed.
(2) If supporting materials submitted with a request clearly
provide information required for a complete request, the materials will
be considered in determining whether the request is complete.
(c) When and where to file. The request for an ALJ hearing or
request for review of a QIC dismissal must be filed--
(1) Within 60 calendar days from the date the party receives notice
of the QIC's reconsideration or dismissal, except as provided in
paragraph (a)(3)(ii) of this section for appeals of extrapolations;
(2) With the office specified in the QIC's reconsideration or
dismissal. If the request for hearing is timely filed with an office
other than the office specified in the QIC's reconsideration, any
applicable time frame specified in Sec. 405.1016 for deciding the
appeal begins on the date the office specified in the QIC's
reconsideration or dismissal receives the request for hearing. If the
request for hearing is filed with an office, other than the entity
office specified in the QIC's reconsideration or dismissal, OMHA must
notify the appellant of the date the request was received in the
correct office and the commencement of any applicable adjudication time
frame.
(d) Copy requirement. (1) The appellant must send a copy of the
request for hearing or request for review of a QIC dismissal to the
other parties who were sent a copy of the QIC's reconsideration or
dismissal. If additional materials submitted with the request are
necessary to provide the information required for a complete request in
accordance with paragraph (b) of this section, copies of the materials
must be sent to the parties as well (subject to authorities that apply
to disclosing the personal information of other parties). If additional
evidence is submitted with the request for hearing, the appellant may
send a copy of the evidence, or briefly describe the evidence pertinent
to the party and offer to provide copies of the evidence to the party
at the party's request (subject to authorities that apply to disclosing
the evidence).
(2) Evidence that a copy of the request for hearing or request for
review of a QIC dismissal, or a copy of submitted evidence or a summary
thereof, was sent in accordance with paragraph (d)(1) of this section
includes--
(i) Certification on the standard form for requesting an ALJ
hearing or requesting a review of a QIC dismissal that a copy of the
request is being sent to the other parties;
(ii) An indication, such as a copy or ``cc'' line, on a request for
hearing or request for review of a QIC dismissal that a copy of the
request and any applicable attachments or enclosures are being sent to
the other parties, including the name and address of the recipient;
(iii) An affidavit or certificate of service that identifies the
name and address of the recipient, and what was sent to the recipient;
or
(iv) A mailing or shipping receipt that identifies the name and
address of the recipient, and what was sent to the recipient.
(3) If the appellant fails to send a copy of the request for
hearing or request for review of a QIC dismissal, any additional
materials, or a copy of submitted evidence or a summary thereof, as
described in paragraph (d)(1) of this section, the appellant will be
provided with an additional opportunity to send the request, materials,
and/or evidence or summary thereof, and if an adjudication time frame
applies, it begins upon receipt of evidence that the request,
materials, and/or evidence or summary thereof were sent. If the
appellant again fails to provide evidence that the request, materials,
and/or evidence or summary thereof were sent within the additional time
frame provided to send the request, materials, and/or evidence or
summary thereof, the appellant's request for hearing or request for
review of a QIC dismissal will be dismissed.
(e) Extension of time to request a hearing or review. (1) If the
request for hearing or review of a QIC dismissal is not filed within 60
calendar days of receipt of the QIC's reconsideration or dismissal, an
appellant may request an extension for good cause (See Sec.
405.942(b)(2) and (3)).
(2) Any request for an extension of time must be in writing, give
the reasons why the request for a hearing or review was not filed
within the stated time period, and must be filed with the request for
hearing or request for review of a QIC dismissal with the office
specified in the notice of reconsideration or dismissal.
(3) An ALJ or attorney adjudicator may find there is good cause for
missing the deadline to file a request for an ALJ hearing or request
for review of a QIC dismissal, or there is no good cause for missing
the deadline to file a request for a review of a QIC dismissal, but
only an ALJ may find there is no good cause for missing the deadline to
file a request for an ALJ hearing. If good cause is found for missing
the deadline, the time period for filing the request for hearing or
request for review of a QIC dismissal will be extended. To determine
whether good cause for late filing exists, the ALJ or attorney
adjudicator uses the standards set forth in Sec. 405.942(b)(2) and
(3).
(4) If a request for hearing is not timely filed, any applicable
adjudication period in Sec. 405.1016 begins the date the ALJ or
attorney adjudicator grants the request to extend the filing deadline.
(5) A determination granting a request to extend the filing
deadline is not subject to further review.
0
29. Section 405.1016 is revised to read as follows:
Sec. 405.1016 Time frames for deciding an appeal of a QIC
reconsideration or escalated request for a QIC reconsideration.
(a) Adjudication period for appeals of QIC reconsiderations. When a
request for an ALJ hearing is filed after a QIC has issued a
reconsideration, an ALJ or attorney adjudicator issues a decision,
dismissal order, or remand to the QIC, as appropriate, no later than
the end of the 90 calendar day period beginning on the date the request
for hearing is received by the office specified in the QIC's notice of
reconsideration, unless the 90 calendar day period has been extended as
provided in this subpart.
(b) When the adjudication period begins. (1) Unless otherwise
specified in this subpart, the adjudication period specified in
paragraph (a) of this section begins on the date that a timely filed
request for hearing is received by the office specified in the QIC's
reconsideration, or, if it is not timely filed, the date that the ALJ
or attorney adjudicator grants any extension to the filing deadline.
(2) If the Council remands a case and the case was subject to an
adjudication time frame under paragraph (a) or (c) of this section, the
remanded appeal will
[[Page 43865]]
be subject to the adjudication time frame of paragraph (a) of this
section beginning on the date that OMHA receives the Council remand.
(c) Adjudication period for escalated requests for QIC
reconsiderations. When an appeal is escalated to OMHA because the QIC
has not issued a reconsideration determination within the period
specified in Sec. 405.970, an ALJ or attorney adjudicator issues a
decision, dismissal order, or remand to the QIC, as appropriate, no
later than the end of the 180 calendar day period beginning on the date
that the request for escalation is received by OMHA in accordance with
Sec. 405.970, unless the 180 calendar day period is extended as
provided in this subpart.
(d) Waivers and extensions of adjudication period. (1) At any time
during the adjudication process, the appellant may waive the
adjudication period specified in paragraphs (a) and (c) of this
section. The waiver may be for a specific period of time agreed upon by
the ALJ or attorney adjudicator and the appellant.
(2) The adjudication periods specified in paragraphs (a) and (c) of
this section are extended as otherwise specified in this subpart, and
for the following events--
(i) The duration of a stay of action on adjudicating the claims or
matters at issue ordered by a court or tribunal of competent
jurisdiction; or
(ii) The duration of a stay of proceedings granted by an ALJ or
attorney adjudicator on a motion by an appellant, provided no other
party also filed a request for hearing on the same claim at issue.
(e) Effect of exceeding adjudication period. If an ALJ or attorney
adjudicator fails to issue a decision, dismissal order, or remand to
the QIC within an adjudication period specified in this section,
subject to paragraphs (b) and (d) of this section, the party that filed
the request for hearing may escalate the appeal in accordance with
paragraph (f) of this section. If the party that filed the request for
hearing does not elect to escalate the appeal, the appeal remains
pending with OMHA for a decision, dismissal order, or remand.
(f) Requesting escalation. (1) When and how to request escalation.
An appellant who files a timely request for hearing before an ALJ and
whose appeal continues to be pending with OMHA at the end of the
applicable adjudication period under paragraph (a) or (c) of this
section, subject to paragraphs (b) and (d) of this section, may
exercise the option of escalating the appeal to the Council by filing a
written request with OMHA to escalate the appeal to the Council and
sending a copy of the request to escalate to the other parties who were
sent a copy of the QIC reconsideration.
(2) Escalation. If the request for escalation meets the
requirements of paragraph (f)(1) of this section and an ALJ or attorney
adjudicator is not able to issue a decision, dismissal order, or remand
order within the later of 5 calendar days of receiving the request for
escalation, or 5 calendar days from the end of the applicable
adjudication period set forth in paragraph (a) or (c) of this section,
subject to paragraphs (b) and (d) of this section, OMHA will take the
following actions--
(i) Send a notice to the appellant stating that an ALJ or attorney
adjudicator is not able to issue a decision, dismissal order, or remand
order within the adjudication period set forth in paragraph (a) or (c)
of this section, the QIC reconsideration will be the decision that is
subject to Council review consistent with Sec. 405.1102(a), and the
appeal will be escalated to the Council for a review in accordance with
Sec. 405.1108; and
(ii) Forward the case file to the Council.
(3) Invalid escalation request. If an ALJ or attorney adjudicator
determines the request for escalation does not meet the requirements of
paragraph (f)(1) of this section, OMHA will send a notice to the
appellant explaining why the request is invalid within 5 calendar days
of receiving the request for escalation.
0
30. Section 405.1018 is revised to read as follows:
Sec. 405.1018 Submitting evidence.
(a) When evidence may be submitted. Except as provided in this
section, parties must submit all written or other evidence they wish to
have considered with the request for hearing, by the date specified in
the request for hearing in accordance with Sec. 405.1014(a)(2), or if
a hearing is scheduled, within 10 calendar days of receiving the notice
of hearing.
(b) Effect on adjudication period. If a party submits written or
other evidence later than 10 calendar days after receiving the notice
of hearing, any applicable adjudication period specified in Sec.
405.1016 is extended by the number of calendar days in the period
between 10 calendar days after receipt of the notice of hearing and the
day the evidence is received.
(c) New evidence. (1) Any evidence submitted by a provider,
supplier, or beneficiary represented by a provider or supplier that is
not submitted prior to the issuance of the QIC's reconsideration
determination must be accompanied by a statement explaining why the
evidence was not previously submitted to the QIC, or a prior decision-
maker (see Sec. 405.1028).
(2) If a statement explaining why the evidence was not previously
submitted to the QIC or a prior decision-maker is not included with the
evidence, the evidence will not be considered.
(d) When this section does not apply. The requirements of this
section do not apply to oral testimony given at a hearing, or to
evidence submitted by an unrepresented beneficiary.
0
31. Section 405.1020 is amended by--
0
a. Revising paragraphs (b), (c), (d), and (e)(3) and (4).
0
b. Adding paragraphs (g)(3)(vii) and (viii).
0
c. Revising paragraphs (h), (i) paragraph heading, and (i)(1), (2),
(4), and (5).
0
d. Adding paragraph (j).
The revisions and additions read as follows:
Sec. 405.1020 Time and place for a hearing before an ALJ.
* * * * *
(b) Determining how appearances are made. (1) Appearances by
unrepresented beneficiaries. The ALJ will direct that the appearance of
an unrepresented beneficiary who filed a request for hearing be
conducted by video-teleconferencing (VTC) if the ALJ finds that VTC
technology is available to conduct the appearance, unless the ALJ find
good cause for an in-person appearance.
(i) The ALJ may also offer to conduct a hearing by telephone if the
request for hearing or administrative record suggests that a telephone
hearing may be more convenient for the unrepresented beneficiary.
(ii) The ALJ, with the concurrence of the Chief ALJ or designee,
may find good cause that an in-person hearing should be conducted if--
(A) VTC or telephone technology is not available; or
(B) Special or extraordinary circumstances exist.
(2) Appearances by individuals other than unrepresented
beneficiaries. The ALJ will direct that the appearance of an
individual, other than an unrepresented beneficiary who filed a request
for hearing, be conducted by telephone, unless the ALJ finds good cause
for an appearance by other means.
(i) The ALJ may find good cause for an appearance by VTC if he or
she determines that VTC is necessary to examine the facts or issues
involved in the appeal.
(ii) The ALJ, with the concurrence of the Chief ALJ or designee,
also may find
[[Page 43866]]
good cause that an in-person hearing should be conducted if--
(A) VTC and telephone technology are not available; or
(B) Special or extraordinary circumstances exist.
(c) Notice of hearing. (1) A notice of hearing is sent to all
parties that filed an appeal or participated in the reconsideration,
any party who was found liable for the services at issue subsequent to
the initial determination or may be found liable based on a review of
the record, the QIC that issued the reconsideration, and CMS or a
contractor that the ALJ believes would be beneficial to the hearing,
advising them of the proposed time and place of the hearing.
(2) The notice of hearing will require all parties to the ALJ
hearing to reply to the notice by:
(i) Acknowledging whether they plan to attend the hearing at the
time and place proposed in the notice of hearing, or whether they
object to the proposed time and/or place of the hearing;
(ii) If the party or representative is an entity or organization,
specifying who from the entity or organization plans to attend the
hearing, if anyone, and in what capacity, in addition to the individual
who filed the request for hearing; and
(iii) Listing the witnesses who will be providing testimony at the
hearing.
(3) The notice of hearing will require CMS or a contractor that
wishes to attend the hearing as a participant to reply to the notice
by:
(i) Acknowledging whether it plans to attend the hearing at the
time and place proposed in the notice of hearing; and
(ii) Specifying who from the entity plans to attend the hearing.
(d) A party's right to waive a hearing. A party may also waive the
right to a hearing and request a decision based on the written evidence
in the record in accordance with Sec. 405.1038(b). As provided in
Sec. 405.1000, an ALJ may require the parties to attend a hearing if
it is necessary to decide the case. If an ALJ determines that it is
necessary to obtain testimony from a non-party, he or she may still
hold a hearing to obtain that testimony, even if all of the parties
have waived the right to appear. In those cases, the ALJ will give the
parties the opportunity to appear when the testimony is given but may
hold the hearing even if none of the parties decide to appear.
(e) * * *
(3) The request must be in writing, except that a party may orally
request that a hearing be rescheduled in an emergency circumstance the
day prior to or day of the hearing. The ALJ must document all oral
requests for a rescheduled hearing in writing and maintain the
documentation in the administrative record.
(4) The ALJ may change the time or place of the hearing if the
party has good cause.
* * * * *
(g) * * *
(3) * * *
(vii) The party or representative has a prior commitment that
cannot be changed without significant expense.
(viii) The party or representative asserts that he or she did not
receive the notice of hearing and is unable to appear at the scheduled
time and place.
(h) Effect of rescheduling hearing. If a hearing is postponed at
the request of the appellant for any of the above reasons, the time
between the originally scheduled hearing date and the new hearing date
is not counted toward the adjudication period specified in Sec.
405.1016.
(i) A party's request for an in-person or VTC hearing. (1) If an
unrepresented beneficiary who filed the request for hearing objects to
a VTC hearing or to the ALJ's offer to conduct a hearing by telephone,
or if a party other than an unrepresented beneficiary who filed the
request for hearing objects to a telephone or VTC hearing, the party
must notify the ALJ at the earliest possible opportunity before the
time set for the hearing and request a VTC or an in-person hearing.
(2) The party must state the reason for the objection and state the
time and/or place he or she wants an in-person or VTC hearing to be
held.
* * * * *
(4) When a party's request for an in-person or VTC hearing as
specified under paragraph (i)(1) of this section is granted and an
adjudication time frame applies in accordance with Sec. 405.1016, the
ALJ issues a decision, dismissal, or remand to the QIC within the
adjudication time frame specified in Sec. 405.1016 (including any
applicable extensions provided in this subpart) unless the party
requesting the hearing agrees to waive such adjudication time frame in
writing.
(5) The ALJ may grant the request, with the concurrence of the
Chief ALJ or designee, upon a finding of good cause and will reschedule
the hearing for a time and place when the party may appear in person or
by VTC before the ALJ.
(j) Amended notice of hearing. If the ALJ changes or will change
the time and/or place of the hearing, an amended notice of hearing must
be sent to all of the parties who were sent a copy of the notice of
hearing and CMS or its contractors that elected to be a participant or
party to the hearing in accordance with Sec. 405.1022(a).
0
32. Section 405.1022 is revised to read as follows:
Sec. 405.1022 Notice of a hearing before an ALJ.
(a) Issuing the notice. After the ALJ sets the time and place of
the hearing, notice of the hearing will be mailed or otherwise
transmitted in accordance with OMHA procedures to the parties and other
potential participants, as provided in Sec. 405.1020(c) at their last
known address, or given by personal service, except to a party or
potential participant who indicates in writing that it does not wish to
receive this notice. The notice is mailed, transmitted, or served at
least 20 calendar days before the hearing unless the recipient agrees
in writing to the notice being mailed, transmitted, or served fewer
than 20 calendar days before the hearing.
(b) Notice information. (1) The notice of hearing contains--
(i) A statement that the issues before the ALJ include all of the
issues brought out in the initial determination, redetermination, or
reconsideration that were not decided entirely in a party's favor, for
the claims specified in the request for hearing; and
(ii) A statement of any specific new issues the ALJ will consider
in accordance with Sec. 405.1032.
(2) The notice will inform the parties that they may designate a
person to represent them during the proceedings.
(3) The notice must include an explanation of the procedures for
requesting a change in the time or place of the hearing, a reminder
that the ALJ may dismiss the hearing request if the appellant fails to
appear at the scheduled hearing without good cause, and other
information about the scheduling and conduct of the hearing.
(4) The appellant will also be told if his or her appearance or
that of any other party or witness is scheduled by VTC, telephone, or
in person. If the ALJ has scheduled the appellant or other party to
appear at the hearing by VTC, the notice of hearing will advise that
the scheduled place for the hearing is a VTC site and explain what it
means to appear at the hearing by VTC.
(5) The notice advises the appellant or other parties that if they
object to appearing by VTC or telephone, and wish instead to have their
hearing at a time and place where they may appear in person before the
ALJ, they must follow the procedures set forth at Sec. 405.1020(i) for
notifying the ALJ of
[[Page 43867]]
their objections and for requesting an in-person hearing.
(c) Acknowledging the notice of hearing. (1) If the appellant, any
other party to the reconsideration to whom the notice of hearing was
sent, or their representative does not acknowledge receipt of the
notice of hearing, OMHA attempts to contact the party for an
explanation.
(2) If the party states that he or she did not receive the notice
of hearing, a copy of the notice is sent to him or her by certified
mail or other means requested by the party and in accordance with OMHA
procedures.
(3) The party may request that the ALJ reschedule the hearing in
accordance with Sec. 405.1020(e).
0
33. Section 405.1024 is amended by revising paragraphs (b) and (c) to
read as follows:
Sec. 405.1024 Objections to the issues.
* * * * *
(b) The party must state the reasons for his or her objections and
send a copy of the objections to all other parties who were sent a copy
of the notice of hearing, and CMS or a contractor that elected to be a
party to the hearing.
(c) The ALJ makes a decision on the objections either in writing,
at a prehearing conference, or at the hearing.
0
34. Section 405.1026 is revised to read as follows:
Sec. 405.1026 Disqualification of the ALJ or attorney adjudicator.
(a) An ALJ or attorney adjudicator cannot adjudicate an appeal if
he or she is prejudiced or partial to any party or has any interest in
the matter pending for decision.
(b) If a party objects to the ALJ or attorney adjudicator assigned
to adjudicate the appeal, the party must notify the ALJ within 10
calendar days of the date of the notice of hearing if a hearing is
scheduled, or the ALJ or attorney adjudicator at any time before a
decision, dismissal order, or remand order is issued if no hearing is
scheduled. The ALJ or attorney adjudicator considers the party's
objections and decides whether to proceed with the appeal or withdraw.
(c) If the ALJ or attorney adjudicator withdraws, another ALJ or
attorney adjudicator will be assigned to adjudicate the appeal. If the
ALJ or attorney adjudicator does not withdraw, the party may, after the
ALJ or attorney adjudicator has issued an action in the case, present
his or her objections to the Council in accordance with Sec. 405.1100
through Sec. 405.1130. The Council will then consider whether the
decision or dismissal should be revised or if applicable, a new hearing
held before another ALJ. If the case is escalated to the Council after
a hearing is held but before the ALJ issues a decision, the Council
considers the reasons the party objected to the ALJ during its review
of the case and, if the Council deems it necessary, may remand the case
to another ALJ for a hearing and decision.
(d) If the party objects to the ALJ or attorney adjudicator and the
ALJ or attorney adjudicator subsequently withdraws from the appeal, any
adjudication time frame that applies to the appeal in accordance with
Sec. 405.1016 is extended by 14 calendar days.
0
35. Section 405.1028 is revised to read as follows:
Sec. 405.1028 Review of evidence submitted by parties.
(a) New evidence--(1) Examination of any new evidence. After a
hearing is requested but before a hearing is held by an ALJ or a
decision is issued if no hearing is held, the ALJ or attorney
adjudicator will examine any new evidence submitted in accordance with
Sec. 405.1018, by a provider, supplier, or beneficiary represented by
a provider or supplier to determine whether the provider, supplier, or
beneficiary represented by a provider or supplier had good cause for
submitting the evidence for the first time at the OMHA level.
(2) Determining if good cause exists. An ALJ or attorney
adjudicator finds good cause when--
(i) The new evidence is, in the opinion of the ALJ or attorney
adjudicator, material to an issue addressed in the QIC's
reconsideration and that issue was not identified as a material issue
prior to the QIC's reconsideration;
(ii) The new evidence is, in the opinion of the ALJ, material to a
new issue identified in accordance with Sec. 405.1032(b)(1);
(iii) The party was unable to obtain the evidence before the QIC
issued its reconsideration and submits evidence that, in the opinion of
the ALJ or attorney adjudicator, demonstrates the party made reasonable
attempts to obtain the evidence before the QIC issued its
reconsideration;
(iv) The party asserts that the evidence was submitted to the QIC
or another contractor and submits evidence that, in the opinion of the
ALJ or attorney adjudicator, demonstrates the new evidence was
submitted to the QIC or another contractor before the QIC issued the
reconsideration; or
(v) In circumstances not addressed in paragraphs (a)(2)(i) through
(iv) of this section, the ALJ or attorney adjudicator determines that
the party has demonstrated that it could not have obtained the evidence
before the QIC issued its reconsideration.
(3) If good cause does not exist. If the ALJ or attorney
adjudicator determines that there was not good cause for submitting the
evidence for the first time at the OMHA level, the ALJ or attorney
adjudicator must exclude the evidence from the proceeding and may not
consider it in reaching a decision.
(4) Notification to parties. If a hearing is conducted, as soon as
possible, but no later than the start of the hearing, the ALJ must
notify all parties and participants who responded to the notice of
hearing whether the evidence will be considered or is excluded from
consideration.
(b) Duplicative evidence. The ALJ or attorney adjudicator may
exclude from consideration any evidence submitted by a party at the
OMHA level that is duplicative of evidence already in the record
forwarded to OMHA.
0
36. Section 405.1030 is revised to read as follows:
Sec. 405.1030 ALJ hearing procedures.
(a) General rule. A hearing is open to the parties and to other
persons the ALJ considers necessary and proper.
(b) At the hearing. (1) At the hearing, the ALJ fully examines the
issues, questions the parties and other witnesses, and may accept
evidence that is material to the issues consistent with Sec. Sec.
405.1018 and 405.1028.
(2) The ALJ may limit testimony and/or argument at the hearing that
are not relevant to an issue before the ALJ, or that address an issue
before the ALJ for which the ALJ determines he or she has sufficient
information or on which the ALJ has already ruled. The ALJ may, but is
not required to, provide the party or representative with an
opportunity to submit additional written statements and affidavits on
the matter, in lieu of testimony and/or argument at the hearing. The
written statements and affidavits must be submitted within the time
frame designated by the ALJ.
(3) If the ALJ determines that a party or party's representative is
uncooperative, disruptive to the hearing, or abusive during the course
of the hearing, the ALJ may excuse the party or representative from the
hearing and continue with the hearing to provide the other parties and
participants with an opportunity to offer testimony and/or argument. If
a party or representative was excused from the hearing, the ALJ will
provide the party or representative with an opportunity to submit
written statements and affidavits
[[Page 43868]]
in lieu of testimony and/or argument at the hearing, and the party or
representative may request a recording of the hearing in accordance
with Sec. 405.1042 and respond in writing to any statements made by
other parties or participants and/or testimony of the witnesses at the
hearing. The written statements and affidavits must be submitted within
the time frame designated by the ALJ.
(c) Missing evidence. The ALJ may also stop the hearing temporarily
and continue it at a later date if he or she believes that there is
material evidence missing at the hearing. If the missing evidence is in
the possession of the appellant, and the appellant is a provider,
supplier, or a beneficiary represented by a provider or supplier, the
ALJ must determine if the appellant had good cause in accordance with
Sec. 405.1028 for not producing the evidence earlier.
(d) Effect of New evidence on adjudication period. If an appellant,
other than an unrepresented beneficiary, submits evidence pursuant to
paragraph (b) or (c) of this section, and an adjudication period
applies to the appeal, the adjudication period specified in Sec.
405.1016 is extended in accordance with Sec. 405.1018(b).
(e) Continued hearing. (1) A hearing may be continued to a later
date. Notice of the continued hearing must be sent in accordance with
Sec. 405.1022, except that a waiver of notice of the hearing may be
made in writing or on the record, and the notice is sent to the parties
and participants who attended the hearing, and any additional parties
or potential parties or participants the ALJ determines are
appropriate.
(2) If the appellant requests the continuance and an adjudication
period applies to the appeal in accordance with Sec. 405.1016, the
adjudication period is extended by the period between the initial
hearing date and the continued hearing date.
(f) Supplemental hearing. (1) The ALJ may conduct a supplemental
hearing at any time before he or she mails a notice of the decision in
order to receive new and material evidence, obtain additional
testimony, or address a procedural matter. The ALJ determines whether a
supplemental hearing is necessary and if one is held, the scope of the
hearing, including when evidence is presented and what issues are
discussed. Notice of the supplemental hearing must be sent in
accordance with Sec. 405.1022, except that the notice is sent to the
parties and participants who attended the hearing, and any additional
parties or potential parties or participants the ALJ determines are
appropriate.
(2) If the appellant requests the supplemental hearing and an
adjudication period applies to the appeal in accordance with Sec.
405.1016, the adjudication period is extended by the period between the
initial hearing date and the supplemental hearing date.
0
37. Section 405.1032 is revised to read as follows:
Sec. 405.1032 Issues before an ALJ or attorney adjudicator.
(a) General rule. The issues before the ALJ or attorney adjudicator
include all the issues for the claims or appealed matter specified in
the request for hearing that were brought out in the initial
determination, redetermination, or reconsideration that were not
decided entirely in a party's favor. (For purposes of this provision,
the term ``party'' does not include a representative of CMS or one of
its contractors that may be participating in the hearing.)
(b) New issues--(1) When a new issue may be considered. A new issue
may include issues resulting from the participation of CMS or its
contractor at the OMHA level of adjudication and from any evidence and
position papers submitted by CMS or its contractor for the first time
to the ALJ. The ALJ or any party may raise a new issue relating to a
claim or appealed matter specified in the request for hearing; however,
the ALJ may only consider a new issue, including a favorable portion of
a determination on a claim or appealed matter specified in the request
for hearing, if its resolution could have a material impact on the
claim or appealed matter and--
(i) There is new and material evidence that was not available or
known at the time of the determination and that may result in a
different conclusion; or
(ii) The evidence that was considered in making the determination
clearly shows on its face that an obvious error was made at the time of
the determination.
(2) Notice of the new issue. The ALJ may consider a new issue at
the hearing if he or she notifies the parties that were or will be sent
the notice of hearing about the new issue before the start of the
hearing.
(3) Opportunity to submit evidence. If notice of the new issue is
sent after the notice of hearing, the parties will have at least 10
calendar days after receiving notice of the new issue to submit
evidence regarding the issue, and without affecting any applicable
adjudication period. If a hearing is conducted before the time to
submit evidence regarding the issue expires, the record will remain
open until the opportunity to submit evidence expires.
(c) Adding claims to a pending appeal. (1) Claims that were not
specified in a request for hearing may only be added to a pending
appeal if the claims were adjudicated in the same reconsideration that
is appealed, and the period to request an ALJ hearing for that
reconsideration has not expired, or an ALJ or attorney adjudicator
extends the time to request an ALJ hearing on those claims in
accordance with Sec. 405.1014(e).
(2) Before a claim may be added to a pending appeal, the appellant
must submit evidence that demonstrates the information that constitutes
a complete request for hearing in accordance with Sec. 405.1014(b) and
other materials related to the claim that the appellant seeks to add to
the pending appeal were sent to the other parties to the claim in
accordance with Sec. 405.1014(d).
(d) Appeals involving statistical sampling and extrapolations. (1)
Generally. If the appellant does not assert the reasons the appellant
disagrees with how a statistical sample and/or extrapolation was
conducted in the request for hearing, in accordance with Sec.
405.1014(a)(3)(iii), issues related to how the statistical sample and
extrapolation were conducted shall not be considered or decided.
(2) Consideration of sample claims. If a party asserts a
disagreement with how a statistical sample and/or extrapolation was
conducted in the request for hearing, in accordance with Sec.
405.1014(a)(3)(iii), paragraphs (a) through (c) of this section apply
to the adjudication of the sample claims but, in deciding issues
related to how a statistical sample and/or extrapolation was conducted
the ALJ or attorney adjudicator must base his or her decision on a
review of the entire sample to the extent appropriate to decide the
issue.
0
38. Section 405.1034 is revised to read as follows:
Sec. 405.1034 Requesting information from the QIC.
(a) If an ALJ or attorney adjudicator believes that the written
record is missing information that is essential to resolving the issues
on appeal and that information can be provided only by CMS or its
contractors, the information may be requested from the QIC that
conducted the reconsideration or its successor.
(1) Official copies of redeterminations and reconsiderations that
were conducted on the appealed claims can be provided only by CMS or
its contractors.
(2) ``Can be provided only by CMS or its contractors'' means the
information
[[Page 43869]]
is not publicly available, is not in the possession of, and cannot be
requested and obtained by one of the parties. Information that is
publicly available is information that is available to the general
public via the Internet or in a printed publication. Information that
is publicly available includes, but is not limited to, information
available on a CMS or contractor Web site or information in an official
CMS or DHHS publication (including, but not limited to, provisions of
NCDs or LCDs, procedure code or modifier descriptions, fee schedule
data, and contractor operating manual instructions).
(b) The ALJ or attorney adjudicator retains jurisdiction of the
case, and the case remains pending at OMHA.
(c) The QIC has 15 calendar days after receiving the request for
information to furnish the information or otherwise respond to the
information request directly or through CMS or another contractor.
(d) If an adjudication period applies to the appeal in accordance
with Sec. 405.1016, the adjudication period is extended by the period
between the date of the request for information and the date the QIC
responds to the request or 20 calendar days after the date of the
request, whichever occurs first.
Sec. 405.1036 [Amended]
0
39. Section 405.1036 is amended by--
0
a. Amending paragraph (b)(1) by removing the phrase ``send the ALJ''
and adding ``submit to OMHA'' in its place.
0
b. Removing paragraph (d).
0
c. Redesignating paragraph (g) as new paragraph (d).
0
d. Amending paragraphs (f)(5)(i), (ii), (iii), (iv), (v), and (vi) by
removing the term ``MAC'' each time it appears and adding ``Council''
in its place.
0
e. Amending paragraphs (f)(5)(i) and (ii) by removing the term
``MAC's'' and adding ``Council's'' in its place.
0
f. Amending paragraph (f)(5)(i) by removing the phrase ``specified in
Sec. 405.1102, Sec. 405.1104, or Sec. 405.1110'' and adding
``specified in Sec. 405.1016(e) and (f), Sec. 405.1102, or Sec.
405.1110'' in its place.
0
g. Amending paragraph (f)(5)(ii) by removing the phrase ``discovery
ruling'' each time it appears and adding ``subpoena ruling'' in its
place.
0
40. Section 405.1037 is amended by--
0
a. Revising paragraph (a)(1).
0
b. Amending paragraph (e)(1) by removing the phrase ``specified in
Sec. 405.1100, Sec. 405.1102, Sec. 405.1104, or Sec. 405.1110'' and
adding ``specified in Sec. 405.1016(e) and (f), Sec. 405.1100, Sec.
405.1102, or Sec. 405.1110'' in its place.
0
c. Amending paragraphs (e)(1), (e)(2) introductory text, (e)(2)(i),
(ii), (iii), (iv), and (v) by removing the term ``MAC'' each time it
appears and adding ``Council'' in its place.
0
d. Amending paragraphs (e)(1) and (e)(2)(i) by removing the term
``MAC's'' and adding ``Council's'' in its place.
0
e. Revising paragraph (f).
The revisions read as follows:
Sec. 405.1037 Discovery.
(a) * * *
(1) Discovery is permissible only when CMS or its contractor elects
to be a party to an ALJ hearing, in accordance with Sec. 405.1012.
* * * * *
(f) Adjudication period. If an adjudication period applies to the
appeal in accordance with Sec. 405.1016, and a party requests
discovery from another party to the hearing, the adjudication period is
extended for the duration of discovery, from the date a discovery
request is granted until the date specified for ending discovery.
0
41. Section 405.1038 is revised to read as follows:
Sec. 405.1038 Deciding a case without a hearing before an ALJ.
(a) Decision fully favorable. If the evidence in the administrative
record supports a finding fully in favor of the appellant(s) on every
issue and no other party to the appeal is liable for claims at issue,
an ALJ or attorney adjudicator may issue a decision without giving the
parties prior notice and without an ALJ conducting a hearing, unless
CMS or a contractor has elected to be a party to the hearing in
accordance with Sec. 405.1012. The notice of the decision informs the
parties that they have the right to a hearing and a right to examine
the evidence on which the decision is based.
(b) Parties do not wish to appear. (1) An ALJ or attorney
adjudicator may decide a case on the record and without an ALJ
conducting a hearing if--
(i) All the parties who would be sent a notice of hearing in
accordance with Sec. 405.1020(c) indicate in writing that they do not
wish to appear before an ALJ at a hearing, including a hearing
conducted by telephone or video-teleconferencing, if available; or
(ii) The appellant lives outside the United States and does not
inform OMHA that he or she wants to appear at a hearing before an ALJ,
and there are no other parties who would be sent a notice of hearing in
accordance with Sec. 405.1020(c) and who wish to appear.
(2) When a hearing is not held, the decision of the ALJ or attorney
adjudicator must refer to the evidence in the record on which the
decision was based.
(c) Stipulated decision. If CMS or one of its contractors submits a
written statement or makes an oral statement at a hearing indicating
the item or service should be covered or payment may be made, an ALJ or
attorney adjudicator may issue a stipulated decision finding in favor
of the appellant or other liable parties on the basis of the statement,
and without making findings of fact, conclusions of law, or further
explaining the reasons for the decision.
0
42. Section 405.1040 is revised to read as follows:
Sec. 405.1040 Prehearing and posthearing conferences.
(a) The ALJ may decide on his or her own, or at the request of any
party to the hearing, to hold a prehearing or posthearing conference to
facilitate the hearing or the hearing decision.
(b) The ALJ informs the parties who will be or were sent a notice
of hearing in accordance with Sec. 405.1020(c), and CMS or a
contractor that has elected to be a participant in the proceedings or
party to the hearing at the time the notice of conference is sent, of
the time, place, and purpose of the conference at least 7 calendar days
before the conference date, unless a party indicates in writing that it
does not wish to receive a written notice of the conference.
(c) At the conference--
(1) The ALJ or an OMHA attorney designated by the ALJ conducts the
conference, but only the ALJ conducting a conference may consider
matters in addition to those stated in the conference notice if the
parties consent to consideration of the additional matters in writing.
(2) An audio recording of the conference is made.
(d) The ALJ issues an order to all parties and participants who
attended the conference stating all agreements and actions resulting
from the conference. If a party does not object within 10 calendar days
of receiving the order, or any additional time granted by the ALJ, the
agreements and actions become part of the administrative record and are
binding on all parties.
0
43. Section 405.1042 is revised to read as follows:
Sec. 405.1042 The administrative record.
(a) Creating the record. (1) OMHA makes a complete record of the
evidence and administrative proceedings on the appealed matter,
including any prehearing and posthearing conferences, and hearing
proceedings that were conducted.
(2) The record will include marked as exhibits, the appealed
determinations,
[[Page 43870]]
and documents and other evidence used in making the appealed
determinations and the ALJ's or attorney adjudicator's decision,
including, but not limited to, claims, medical records, written
statements, certificates, reports, affidavits, and any other evidence
the ALJ or attorney adjudicator admits. The record will also include
any evidence excluded or not considered by the ALJ or attorney
adjudicator, including, but not limited to, new evidence submitted by a
provider or supplier, or beneficiary represented by a provider or
supplier, for which no good cause was established, and duplicative
evidence submitted by a party.
(3) A party may request and review a copy of the record prior to or
at the hearing, or, if a hearing is not held, at any time before the
notice of decision is issued.
(4) If a request for review is filed or the case is escalated to
the Council, the complete record, including any prehearing and
posthearing conference and hearing recordings, is forwarded to the
Council.
(5) A typed transcription of the hearing is prepared if a party
seeks judicial review of the case in a Federal district court within
the stated time period and all other jurisdictional criteria are met,
unless, upon the Secretary's motion prior to the filing of an answer,
the court remands the case.
(b) Requesting and receiving copies of the record. (1) While an
appeal is pending at OMHA, a party may request and receive a copy of
all or part of the record from OMHA, including any index of the
administrative record, documentary evidence, and a copy of the audio
recording of the oral proceedings. The party may be asked to pay the
costs of providing these items.
(2) If a party requests a copy of all or part of the record from
OMHA or the ALJ or attorney adjudicator and an opportunity to comment
on the record, any adjudication period that applies in accordance with
Sec. 405.1016 is extended by the time beginning with the receipt of
the request through the expiration of the time granted for the party's
response.
(3) If a party requests a copy of all or part of the record and the
record, including any audio recordings, contains information pertaining
to an individual that the requesting party is not entitled to receive,
such as personally identifiable information or protected health
information, such portions of the record will not be furnished unless
the requesting party obtains consent from the individual.
0
44. Section 405.1044 is revised to read as follows:
Sec. 405.1044 Consolidated proceedings.
(a) Consolidated hearing. (1) A consolidated hearing may be held if
one or more of the issues to be considered at the hearing are the same
issues that are involved in one or more other appeals pending before
the same ALJ.
(2) It is within the discretion of the ALJ to grant or deny an
appellant's request for consolidation. In considering an appellant's
request, the ALJ may consider factors such as whether the claims at
issue may be more efficiently decided if the appeals are consolidated
for hearing. In considering the appellant's request for consolidation,
the ALJ must take into account any adjudication deadlines for each
appeal and may require an appellant to waive the adjudication deadline
associated with one or more appeals if consolidation otherwise prevents
the ALJ from deciding all of the appeals at issue within their
respective deadlines.
(3) The ALJ may also propose on his or her own motion to
consolidate two or more appeals in one hearing for administrative
efficiency, but may not require an appellant to waive the adjudication
deadline for any of the consolidated cases.
(4) Notice of a consolidated hearing must be included in the notice
of hearing issued in accordance with Sec. Sec. 405.1020 and 405.1022.
(b) Consolidated or separate decision and record. (1) If the ALJ
decides to hold a consolidated hearing, he or she may make either--
(i) A consolidated decision and record; or
(ii) A separate decision and record on each appeal.
(2) If a separate decision and record on each appeal is made, the
ALJ is responsible for making sure that any evidence that is common to
all appeals and material to the common issue to be decided, and audio
recordings of any conferences that were conducted and the consolidated
hearing are included in each individual administrative record, as
applicable.
(3) If a hearing will not be conducted for multiple appeals that
are before the same ALJ or attorney adjudicator, and the appeals
involve one or more of the same issues, the ALJ or attorney adjudicator
may make a consolidated decision and record at the request of the
appellant or on the ALJ's or attorney adjudicator's own motion.
(c) Limitation on consolidated proceedings. Consolidated
proceedings may only be conducted for appeals filed by the same
appellant, unless multiple appellants aggregated claims to meet the
amount in controversy requirement in accordance with Sec. 405.1006 and
the beneficiaries whose claims are at issue have all authorized
disclosure of their protected information to the other parties and any
participants.
0
45. Section 405.1046 is revised to read as follows:
Sec. 405.1046 Notice of an ALJ or attorney adjudicator decision.
(a) Decisions on requests for hearing--(1) General rule. Unless the
ALJ or attorney adjudicator dismisses or remands the request for
hearing, the ALJ or attorney adjudicator will issue a written decision
that gives the findings of fact, conclusions of law, and the reasons
for the decision. The decision must be based on evidence offered at the
hearing or otherwise admitted into the record, and shall include
independent findings and conclusions. OMHA mails or otherwise transmits
a copy of the decision to all the parties at their last known address
and the QIC that issued the reconsideration or from which the appeal
was escalated. For overpayment cases involving multiple beneficiaries,
where there is no beneficiary liability, the ALJ or attorney
adjudicator may choose to send written notice only to the appellant. In
the event a payment will be made to a provider or supplier in
conjunction with the ALJ's or attorney adjudicator's decision, the
contractor must also issue a revised electronic or paper remittance
advice to that provider or supplier.
(2) Content of the notice. The decision must be written in a manner
calculated to be understood by a beneficiary and must include--
(i) The specific reasons for the determination, including, to the
extent appropriate, a summary of any clinical or scientific evidence
used in making the determination;
(ii) For any new evidence that was submitted for the first time at
the OMHA level and subject to a good cause determination pursuant to
Sec. 405.1028, a discussion of the new evidence and the good cause
determination that was made.
(iii) The procedures for obtaining additional information
concerning the decision; and
(iv) Notification of the right to appeal the decision to the
Council, including instructions on how to initiate an appeal under this
section.
(3) Limitation on decision. When the amount of payment for an item
or service is an issue before the ALJ or attorney adjudicator, the ALJ
or attorney adjudicator may make a finding as to the amount of payment
due. If the ALJ or attorney adjudicator makes a finding concerning
payment when the amount of payment was not an issue before the
[[Page 43871]]
ALJ or attorney adjudicator, the contractor may independently determine
the payment amount. In either of the aforementioned situations, an
ALJ's or attorney adjudicator's decision is not binding on the
contractor for purposes of determining the amount of payment due. The
amount of payment determined by the contractor in effectuating the
ALJ's or attorney adjudicator's decision is a new initial determination
under Sec. 405.924.
(b) Decisions on requests for review of a QIC dismissal--(1)
General rule. Unless the ALJ or attorney adjudicator dismisses the
request for review of a QIC dismissal, or the QIC's dismissal is
vacated and remanded, the ALJ or attorney adjudicator will issue a
written decision affirming the QIC's dismissal. OMHA mails or otherwise
transmits a copy of the decision to all the parties that received a
copy of the QIC's dismissal.
(2) Content of the notice. The decision must be written in a manner
calculated to be understood by a beneficiary and must include--
(i) The specific reasons for the determination, including a summary
of the evidence considered and applicable authorities;
(ii) The procedures for obtaining additional information concerning
the decision; and
(iii) Notification that the decision is binding and is not subject
to further review, unless reopened and revised by the ALJ or attorney
adjudicator.
(c) Recommended decision. An ALJ or attorney adjudicator issues a
recommended decision if he or she is directed to do so in the Council's
remand order. An ALJ or attorney adjudicator may not issue a
recommended decision on his or her own motion. The ALJ or attorney
adjudicator mails a copy of the recommended decision to all the parties
at their last known address.
0
46. Section 405.1048 is revised to read as follows:
Sec. 405.1048 The effect of an ALJ's or attorney adjudicator's
decision.
(a) The decision of the ALJ or attorney adjudicator on a request
for hearing is binding on all parties unless--
(1) A party requests a review of the decision by the Council within
the stated time period or the Council reviews the decision issued by an
ALJ or attorney adjudicator under the procedures set forth in Sec.
405.1110, and the Council issues a final decision or remand order or
the appeal is escalated to Federal district court under the provisions
at Sec. 405.1132 and the Federal district court issues a decision.
(2) The decision is reopened and revised by an ALJ or attorney
adjudicator or the Council under the procedures explained in Sec.
405.980;
(3) The expedited access to judicial review process at Sec.
405.990 is used;
(4) The ALJ's or attorney adjudicator's decision is a recommended
decision directed to the Council and the Council issues a decision; or
(5) In a case remanded by a Federal district court, the Council
assumes jurisdiction under the procedures in Sec. 405.1138 and the
Council issues a decision.
(b) The decision of the ALJ or attorney adjudicator on a request
for review of a QIC dismissal is binding on all parties unless the
decision is reopened and revised by the ALJ or attorney adjudicator
under the procedures in Sec. 405.980.
Sec. 405.1050 [Amended]
0
47. Section 405.1050 is amended by--
0
a. Amending the section heading by removing the phrase ``an ALJ'' and
adding ``OMHA'' in its place.
0
b. Amending the text of the section by removing the phrase ``pending
before an ALJ'' and adding ``pending before OMHA'' in its place, and by
removing the term ``the ALJ'' and adding ``OMHA'' in its place.
0
c. Amending the section heading and the text of the section by removing
the term ``MAC'' each time it appears and adding ``Council'' in its
place.
0
48. Section 405.1052 is revised to read as follows:
Sec. 405.1052 Dismissal of a request for a hearing before an ALJ or
request for review of a QIC dismissal.
(a) Dismissal of request for hearing. An ALJ dismisses a request
for a hearing under any of the following conditions:
(1) Neither the party that requested the hearing nor the party's
representative appears at the time and place set for the hearing, if--
(i) The party was notified before the time set for the hearing that
the request for hearing might be dismissed for failure to appear, the
record contains documentation that the party acknowledged the notice of
hearing, and the party does not contact the ALJ within 10 calendar days
after the hearing, or does contact the ALJ but the ALJ determines the
party did not demonstrate good cause for not appearing; or
(ii) The record does not contain documentation that the party
acknowledged the notice of hearing, the ALJ sends a notice to the party
at the last known address asking why the party did not appear, and the
party does not respond to the ALJ's notice within 10 calendar days
after receiving the notice or does contact the ALJ but the ALJ
determines the party did not demonstrate good cause for not appearing.
(iii) In determining whether good cause exists under paragraphs
(a)(1)(i) and (ii) of this section, the ALJ considers any physical,
mental, educational, or linguistic limitations (including any lack of
facility with the English language), that the party may have.
(2) The person or entity requesting a hearing has no right to it
under Sec. 405.1002.
(3) The party did not request a hearing within the stated time
period and the ALJ or attorney adjudicator has not found good cause for
extending the deadline, as provided in Sec. 405.1014(e).
(4) The beneficiary whose claim is being appealed died while the
request for hearing is pending and all of the following criteria apply:
(i) The request for hearing was filed by the beneficiary or the
beneficiary's representative, and the beneficiary's surviving spouse or
estate has no remaining financial interest in the case. In deciding
this issue, the ALJ or attorney adjudicator considers if the surviving
spouse or estate remains liable for the services that were denied or a
Medicare contractor held the beneficiary liable for subsequent similar
services under the limitation of liability provisions based on the
denial of the services at issue.
(ii) No other individuals or entities that have a financial
interest in the case wish to pursue an appeal under Sec. 405.1002.
(iii) No other individual or entity filed a valid and timely
request for an ALJ hearing in accordance to Sec. 405.1014.
(5) The ALJ or attorney adjudicator dismisses a hearing request
entirely or refuses to consider any one or more of the issues because a
QIC, an ALJ or attorney adjudicator, or the Council has made a previous
determination or decision under this subpart about the appellant's
rights on the same facts and on the same issue(s) or claim(s), and this
previous determination or decision has become binding by either
administrative or judicial action.
(6) The appellant abandons the request for hearing. An ALJ or
attorney adjudicator may conclude that an appellant has abandoned a
request for hearing when OMHA attempts to schedule a hearing and is
unable to contact the appellant after making reasonable efforts to do
so.
(7) The appellant's request is not complete in accordance with
[[Page 43872]]
Sec. 405.1014(a)(1) or the appellant did not send a copy of its
request to the other parties in accordance with Sec. 405.1014(d),
after the appellant is provided with an opportunity to complete the
request and/or send a copy of the request to the other parties.
(b) Dismissal of request for review of a QIC dismissal. An ALJ or
attorney adjudicator dismisses a request for review of a QIC dismissal
under any of the following conditions:
(1) The person or entity requesting a review of a dismissal has no
right to it under Sec. 405.1004.
(2) The party did not request a review within the stated time
period and the ALJ or attorney adjudicator has not found good cause for
extending the deadline, as provided in Sec. 405.1014(e).
(3) The beneficiary whose claim is being appealed died while the
request for review is pending and all of the following criteria apply:
(i) The request for review was filed by the beneficiary or the
beneficiary's representative, and the beneficiary's surviving spouse or
estate has no remaining financial interest in the case. In deciding
this issue, the ALJ or attorney adjudicator considers if the surviving
spouse or estate remains liable for the services that were denied or a
Medicare contractor held the beneficiary liable for subsequent similar
services under the limitation of liability provisions based on the
denial of the services at issue.
(ii) No other individuals or entities that have a financial
interest in the case wish to pursue an appeal under Sec. 405.1004.
(iii) No other individual or entity filed a valid and timely
request for a review of the QIC dismissal in accordance to Sec.
405.1014.
(4) The appellant's request is not complete in accordance with
Sec. 405.1014(a)(1) or the appellant did not send a copy of its
request to the other parties in accordance with Sec. 405.1014(d),
after the appellant is provided with an opportunity to complete the
request and/or send a copy of the request to the other parties.
(c) Withdrawal of request. At any time before notice of the
decision, dismissal, or remand is mailed, if only one party requested
the hearing or review of the QIC dismissal and that party asks to
withdraw the request, an ALJ or attorney adjudicator may dismiss the
request for hearing or request for review of a QIC dismissal. This
request for withdrawal may be submitted in writing, or a request to
withdraw a request for hearing may be made orally at a hearing before
the ALJ. The request for withdrawal must include a clear statement that
the appellant is withdrawing the request for hearing or review of the
QIC dismissal and does not intend to further proceed with the appeal.
If an attorney or other legal professional on behalf of a beneficiary
or other appellant files the request for withdrawal, the ALJ or
attorney adjudicator may presume that the representative has advised
the appellant of the consequences of the withdrawal and dismissal.
(d) Notice of dismissal. OMHA mails or otherwise transmits a
written notice of the dismissal of the hearing or review request to all
parties who were sent a copy of the request for hearing or review at
their last known address. The notice states that there is a right to
request that the ALJ or attorney adjudicator vacate the dismissal
action. The appeal will proceed with respect to any other parties who
filed a valid request for hearing or review regarding the same claim or
disputed matter.
(e) Vacating a dismissal. If good and sufficient cause is
established, the ALJ or attorney adjudicator may vacate his or her
dismissal of a request for hearing or review within 6 months of the
date of the notice of dismissal.
0
49. Section 405.1054 is revised to read as follows:
Sec. 405.1054 Effect of dismissal of a request for a hearing or
request for review of QIC dismissal.
(a) The dismissal of a request for a hearing is binding, unless it
is vacated by the Council under Sec. 405.1108(b), or vacated by the
ALJ or attorney adjudicator under Sec. 405.1052(e).
(b) The dismissal of a request for review of a QIC dismissal of a
request for reconsideration is binding and not subject to further
review unless it is vacated by the ALJ or attorney adjudicator under
Sec. 405.1052(e).
0
50. Section 405.1056 is added before the undesignated center heading
``Applicability of Medicare Coverage Policies'' to read as follows:
Sec. 405.1056 Remands of requests for hearing and requests for
review.
(a) Missing appeal determination or case record. (1) If an ALJ or
attorney adjudicator requests an official copy of a missing
redetermination or reconsideration for an appealed claim in accordance
with Sec. 405.1034, and the QIC or another contractor does not furnish
the copy within the time frame specified in Sec. 405.1034, the ALJ or
attorney adjudicator may issue a remand directing the QIC or other
contractor to reconstruct the record or, if it is not able to do so,
initiate a new appeal adjudication.
(2) If the QIC does not furnish the case file for an appealed
reconsideration, an ALJ or attorney adjudicator may issue a remand
directing the QIC to reconstruct the record or, if it is not able to do
so, initiate a new appeal adjudication.
(3) If the QIC or another contractor is able to reconstruct the
record for a remanded case and returns the case to OMHA, the case is no
longer remanded and the reconsideration is no longer vacated, and any
adjudication period that applies to the appeal in accordance with Sec.
405.1016 is extended by the period between the date of the remand and
the date that case is returned to OMHA.
(b) No redetermination. If an ALJ or attorney adjudicator finds
that the QIC issued a reconsideration that addressed coverage or
payment issues related to the appealed claim and no redetermination of
the claim was made (if a redetermination was required under this
subpart) or the request for redetermination was dismissed, the
reconsideration will be remanded to the QIC, or its successor to re-
adjudicate the request for reconsideration.
(c) Requested remand--(1) Request contents and timing. At any time
prior to an ALJ or attorney adjudicator issuing a decision or
dismissal, the appellant and CMS or one of its contractors may jointly
request a remand of the appeal to the entity that conducted the
reconsideration. The request must include the reasons why the appeal
should be remanded and indicate whether remanding the case will likely
resolve the matter in dispute.
(2) Granting the request. An ALJ or attorney adjudicator may grant
the request and issue a remand if he or she determines that remanding
the case will likely resolve the matter in dispute.
(d) Remanding a QIC's dismissal of a request for reconsideration.
Consistent with Sec. 405.1004(b), an ALJ or attorney adjudicator will
remand a case to the appropriate QIC if the ALJ or attorney adjudicator
determines that a QIC's dismissal of a request for reconsideration was
in error.
(e) Relationship to local and national coverage determination
appeals process. (1) An ALJ or attorney adjudicator remands an appeal
to the QIC that made the reconsideration if the appellant is entitled
to relief pursuant to Sec. Sec. 426.460(b)(1), 426.488(b), or
426.560(b)(1) of this chapter.
(2) Unless the appellant is entitled to relief pursuant to
Sec. Sec. 426.460(b)(1), 426.488(b), or 426.560(b)(1) of this chapter,
the ALJ or attorney adjudicator applies the LCD or NCD in place on the
date the item or service was provided.
[[Page 43873]]
(f) Notice of a remand. OMHA mails or otherwise transmits a written
notice of the remand of the request for hearing or request for review
to all of the parties who were sent a copy of the request at their last
known address, and CMS or a contractor that elected to be a participant
in the proceedings or party to the hearing. The notice states that
there is a right to request that the Chief ALJ or a designee review the
remand.
(g) Review of remand. Upon a request by a party or CMS or one of
its contractors filed within 30 calendar days of receiving a notice of
remand, the Chief ALJ or designee will review the remand, and if the
remand is not authorized by this section, vacate the remand order. The
determination on a request to review a remand order is binding and not
subject to further review.
0
51. Section 405.1058 is added before the undesignated center heading
``Applicability of Medicare Coverage Policies'' to read as follows:
Sec. 405.1058 Effect of a remand.
A remand of a request for hearing or request for review is binding
unless vacated by the Chief ALJ or a designee in accordance with Sec.
405.1056(g).
Sec. 405.1060 [Amended]
0
52. Section 405.1060 is amended by--
0
a. Amending paragraph (a)(4) by removing the term ``ALJs'' and adding
``ALJs and attorney adjudicators'' in its place.
0
b. Amending paragraphs (a)(4), (c) paragraph heading, (c)(1), and
(c)(2) by removing the term ``MAC'' and adding ``Council'' in its
place.
0
c. Amending paragraphs (b) paragraph heading, (b)(1), and (b)(2) by
removing the term ``ALJ'' and adding ``ALJ or attorney adjudicator'' in
its place.
Sec. 405.1062 [Amended]
0
53. Section 405.1062 is amended by--
0
a. Amending the section heading and paragraphs (a) and (b) by removing
the term ``MAC'' each time it appears and adding ``Council'' in its
place.
0
b. Amending the section heading and paragraph (b) by removing the term
``ALJ'' each time it appears and adding ``ALJ or attorney adjudicator''
in its place.
0
c. Amending paragraph (a) by removing the term ``ALJs'' and adding
``ALJs and attorney adjudicators'' in its place.
0
d. Amending paragraph (c) by removing the phrase ``An ALJ or MAC'' and
adding ``An ALJ or attorney adjudicator or the Council'' in its place.
0
54. Section 405.1063 is revised to read as follows:
Sec. 405.1063 Applicability of laws, regulations, CMS Rulings, and
precedential decisions.
(a) All laws and regulations pertaining to the Medicare and
Medicaid programs, including, but not limited to Titles XI, XVIII, and
XIX of the Social Security Act and applicable implementing regulations,
are binding on ALJs and attorney adjudicators, and the Council.
(b) CMS Rulings are published under the authority of the
Administrator, CMS. Consistent with Sec. 401.108 of this chapter,
rulings are binding on all CMS components, on all HHS components that
adjudicate matters under the jurisdiction of CMS, and on the Social
Security Administration to the extent that components of the Social
Security Administration adjudicate matters under the jurisdiction of
CMS.
(c) Precedential decisions designated by the Chair of the
Departmental Appeals Board in accordance with Sec. 401.109 of this
chapter, are binding on all CMS components, all HHS components that
adjudicate matters under the jurisdiction of CMS, and on the Social
Security Administration to the extent that components of the Social
Security Administration adjudicate matters under the jurisdiction of
CMS.
Sec. 405.1064 [Removed]
0
55. Section 405.1064 is removed.
0
56. Section 405.1100 is revised to read as follows:
Sec. 405.1100 Medicare Appeals Council review: General.
(a) The appellant or any other party to an ALJ's or attorney
adjudicator's decision or dismissal may request that the Council review
the ALJ's or attorney adjudicator's decision or dismissal.
(b) Under circumstances set forth in Sec. Sec. 405.1016 and
405.1108, the appellant may request that a case be escalated to the
Council for a decision even if the ALJ or attorney adjudicator has not
issued a decision, dismissal, or remand in his or her case.
(c) When the Council reviews an ALJ's or attorney adjudicator's
decision, it undertakes a de novo review. The Council issues a final
decision or dismissal order or remands a case to the ALJ or attorney
adjudicator within 90 calendar days of receipt of the appellant's
request for review, unless the 90 calendar day period is extended as
provided in this subpart.
(d) When deciding an appeal that was escalated from the OMHA level
to the Council, the Council will issue a final decision or dismissal
order or remand the case to the OMHA Chief ALJ within 180 calendar days
of receipt of the appellant's request for escalation, unless the 180
calendar day period is extended as provided in this subpart.
0
57. Section 405.1102 is revised to read as follows:
Sec. 405.1102 Request for Council review when ALJ or attorney
adjudicator issues decision or dismissal.
(a)(1) A party to a decision or dismissal issued by an ALJ or
attorney adjudicator may request a Council review if the party files a
written request for a Council review within 60 calendar days after
receipt of the ALJ's or attorney adjudicator's decision or dismissal.
(2) For purposes of this section, the date of receipt of the ALJ's
or attorney adjudicator's decision or dismissal is presumed to be 5
calendar days after the date of the notice of the decision or
dismissal, unless there is evidence to the contrary.
(3) The request is considered as filed on the date it is received
by the entity specified in the notice of the ALJ's or attorney
adjudicator's action.
(b) A party requesting a review may ask that the time for filing a
request for Council review be extended if--
(1) The request for an extension of time is in writing;
(2) It is filed with the Council; and
(3) It explains why the request for review was not filed within the
stated time period. If the Council finds that there is good cause for
missing the deadline, the time period will be extended. To determine
whether good cause exists, the Council uses the standards outlined at
Sec. 405.942(b)(2) and (3).
(c) A party does not have the right to seek Council review of an
ALJ's or attorney adjudicator's remand to a QIC, affirmation of a QIC's
dismissal of a request for reconsideration, or dismissal of a request
for review of a QIC dismissal.
(d) For purposes of requesting Council review (Sec. Sec. 405.1100
through 405.1140), unless specifically excepted, the term ``party'',
includes CMS where CMS has entered into a case as a party according to
Sec. 405.1012. The term, ``appellant,'' does not include CMS, where
CMS has entered into a case as a party according to Sec. 405.1012.
Sec. 405.1104 [Removed]
0
58. Section 405.1104 is removed.
0
59. Section 405.1106 is revised to read as follows:
Sec. 405.1106 Where a request for review or escalation may be filed.
(a) When a request for a Council review is filed after an ALJ or
attorney adjudicator has issued a decision or dismissal, the request
for review must
[[Page 43874]]
be filed with the entity specified in the notice of the ALJ's or
attorney adjudicator's action. The appellant must also send a copy of
the request for review to the other parties to the ALJ or attorney
adjudicator decision or dismissal who received notice of the decision
or dismissal. Failure to copy the other parties tolls the Council's
adjudication deadline set forth in Sec. 405.1100 until all parties to
the ALJ or attorney adjudicator decision or dismissal receive notice of
the request for Council review. If the request for review is timely
filed with an entity other than the entity specified in the notice of
the ALJ's or attorney adjudicator's action, the Council 's adjudication
period to conduct a review begins on the date the request for review is
received by the entity specified in the notice of the ALJ's or attorney
adjudicator's action. Upon receipt of a request for review from an
entity other than the entity specified in the notice of the ALJ's or
attorney adjudicator's action, the Council sends written notice to the
appellant of the date of receipt of the request and commencement of the
adjudication timeframe.
(b) If an appellant files a request to escalate an appeal to the
Council level because the ALJ or attorney adjudicator has not completed
his or her action on the request for hearing within an applicable
adjudication period under Sec. 405.1016, the request for escalation
must be filed with OMHA and the appellant must also send a copy of the
request for escalation to the other parties who were sent a copy of the
QIC reconsideration. Failure to copy the other parties tolls the
Council's adjudication deadline set forth in Sec. 405.1100 until all
parties who were sent a copy of the QIC reconsideration receive notice
of the request for escalation. In a case that has been escalated from
OMHA, the Council's 180 calendar day period to issue a final decision,
dismissal order, or remand order begins on the date the request for
escalation is received by the Council.
Sec. 405.1108 [Amended]
0
60. Section 405.1108 is amended by--
0
a. Amending the section heading and paragraphs (a), (b), (c), (d)
introductory text, (d)(2), and (4) by removing the term ``MAC'' each
time it appears and adding ``Council'' in its place.
0
b. Amending paragraphs (a), (b), (c), (d)(1), and (5) by removing the
term ``ALJ'' each time it appears and adding ``ALJ or attorney
adjudicator'' in its place.
0
c. Amending paragraphs (a) and (b) by removing the term ``ALJ's'' each
time it appears and adding ``ALJ's or attorney adjudicator's'' in its
place.
0
d. Amending paragraph (b) by removing the first use of ``dismissal'' in
the paragraph and adding ``dismissal of a request for a hearing'' in
its place.
0
e. Amending paragraph (d) introductory text by removing the term ``ALJ
level'' and adding ``OMHA level'' in its place.
0
f. Amending paragraph (d)(3) by removing the phrase ``to an ALJ'' and
adding ``to OMHA'' in its place.
0
61. Section 405.1110 is revised to read as follows:
Sec. 405.1110 Council reviews on its own motion.
(a) General rule. The Council may decide on its own motion to
review a decision or dismissal issued by an ALJ or attorney
adjudicator. CMS or any of its contractors may refer a case to the
Council for it to consider reviewing under this authority anytime
within 60 calendar days after the date of an ALJ's or attorney
adjudicator's decision or dismissal.
(b) Referral of cases. (1) CMS or any of its contractors may refer
a case to the Council if, in their view, the decision or dismissal
contains an error of law material to the outcome of the claim or
presents a broad policy or procedural issue that may affect the public
interest. CMS may also request that the Council take own motion review
of a case if--
(i) CMS or its contractor participated in the appeal at the OMHA
level; and
(ii) In CMS' view, the ALJ's or attorney adjudicator's decision or
dismissal is not supported by the preponderance of evidence in the
record or the ALJ or attorney adjudicator abused his or her discretion.
(2) CMS' referral to the Council is made in writing and must be
filed with the Council no later than 60 calendar days after the ALJ's
or attorney adjudicator's decision or dismissal is issued. The written
referral will state the reasons why CMS believes the Council must
review the case on its own motion. CMS will send a copy of its referral
to all parties to the ALJ's or attorney adjudicator's action who
received a copy of the hearing decision under Sec. 405.1046(a) or the
notice of dismissal under Sec. 405.1052(d), and to the OMHA Chief ALJ.
Parties to the ALJ's or attorney adjudicator's action may file
exceptions to the referral by submitting written comments to the
Council within 20 calendar days of the referral notice. A party
submitting comments to the Council must send such comments to CMS and
all other parties to the ALJ's or attorney adjudicator's action who
received a copy of the hearing decision under Sec. 405.1046(a) or the
notice of dismissal under Sec. 405.1052(d).
(c) Standard of review--(1) Referral by CMS after participation at
the OMHA level. If CMS or its contractor participated in an appeal at
the OMHA level, the Council exercises its own motion authority if there
is an error of law material to the outcome of the case, an abuse of
discretion by the ALJ or attorney adjudicator, the decision is not
consistent with the preponderance of the evidence of record, or there
is a broad policy or procedural issue that may affect the general
public interest. In deciding whether to accept review under this
standard, the Council will limit its consideration of the ALJ's or
attorney adjudicator's action to those exceptions raised by CMS.
(2) Referral by CMS when CMS did not participate in the OMHA
proceedings or appear as a party. The Council will accept review if the
decision or dismissal contains an error of law material to the outcome
of the case or presents a broad policy or procedural issue that may
affect the general public interest. In deciding whether to accept
review, the Council will limit its consideration of the ALJ's or
attorney adjudicator's action to those exceptions raised by CMS.
(d) Council's action. If the Council decides to review a decision
or dismissal on its own motion, it will mail the results of its action
to all the parties to the hearing and to CMS if it is not already a
party to the hearing. The Council may adopt, modify, or reverse the
decision or dismissal, may remand the case to an ALJ or attorney
adjudicator for further proceedings or may dismiss a hearing request.
The Council must issue its action no later than 90 calendar days after
receipt of the CMS referral, unless the 90 calendar day period has been
extended as provided in this subpart. The Council may not, however,
issue its action before the 20 calendar day comment period has expired,
unless it determines that the agency's referral does not provide a
basis for reviewing the case. If the Council does not act within the
applicable adjudication deadline, the ALJ's or attorney adjudicator's
decision or dismissal is binding on the parties to the ALJ's or
attorney adjudicator's action.
0
62. Section 405.1112 is revised to read as follows:
Sec. 405.1112 Content of request for review.
(a) The request for Council review must be filed with the entity
specified in the notice of the ALJ's or attorney adjudicator's action.
The request for
[[Page 43875]]
review must be in writing and may be made on a standard form. A written
request that is not made on a standard form is accepted if it contains
the beneficiary's name; Medicare health insurance claim number; the
specific service(s) or item(s) for which the review is requested; the
specific date(s) of service; the date of the ALJ's or attorney
adjudicator's decision or dismissal order, if any; and the name and
signature of the party or the representative of the party; and any
other information CMS may decide.
(b) The request for review must identify the parts of the ALJ's or
attorney adjudicator's action with which the party requesting review
disagrees and explain why he or she disagrees with the ALJ's or
attorney adjudicator's decision, dismissal, or other determination
being appealed. For example, if the party requesting review believes
that the ALJ's or attorney adjudicator's action is inconsistent with a
statute, regulation, CMS Ruling, or other authority, the request for
review should explain why the appellant believes the action is
inconsistent with that authority.
(c) The Council will limit its review of an ALJ's or attorney
adjudicator's actions to those exceptions raised by the party in the
request for review, unless the appellant is an unrepresented
beneficiary. For purposes of this section only, we define a
representative as anyone who has accepted an appointment as the
beneficiary's representative, except a member of the beneficiary's
family, a legal guardian, or an individual who routinely acts on behalf
of the beneficiary, such as a family member or friend who has a power
of attorney.
Sec. 405.1114 [Amended]
0
63. Section 405.1114 is amended by--
0
a. Amending the introductory text and paragraphs (b) and (c)(1) by
removing the term ``MAC'' each time it appears and adding ``Council''
in its place.
0
b. Amending paragraph (c)(3) by removing the phrase ``ALJ hearing'' and
adding ``ALJ's or attorney adjudicator's action'' in its place.
Sec. 405.1116 [Amended]
0
64. Section 405.1116 is amended by--
0
a. Removing the term ``MAC'' each time it appears in the heading and
text and adding ``Council'' in its place.
0
b. Removing the term ``MAC's'' and adding ``Council's'' in its place.
0
c. Removing the term ``ALJ'' and adding ``ALJ or attorney adjudicator''
in its place.
Sec. 405.1118 [Amended]
0
65. Section 405.1118 is amended by--
0
a. Removing the term ``MAC'' each time it appears in the heading and
text and adding ``Council'' in its place.
0
b. Removing the phrase ``ALJ hearing'' and adding ``ALJ's or attorney
adjudicator's action'' in its place.
0
c. Removing the phrase ``the exhibits list'' and adding ``any index of
the administrative record'' in its place.
0
d. Removing the term ``tape'' and adding ``audio recording'' in its
place.
0
e. Removing the term ``MAC's'' and adding ``Council's'' in its place.
Sec. 405.1120 [Amended]
0
66. Section 405.1120 is amended in the heading and text by removing the
term ``MAC'' each time it appears and adding ``Council'' in its place.
Sec. 405.1122 [Amended]
0
67. Section 405.1122 is amended by--
0
a. Amending the section heading and paragraphs (a) paragraph heading,
(a)(1) and (2), (b) paragraph heading, (b)(1) and (2), (c)(1), (2), and
(3) introductory text, (c)(3)(ii), (d)(1) and (3), (e)(1), (2), (3),
and (4), and (f)(1), (2), and (3) by removing the term ``MAC'' each
time it appears and adding ``Council'' in its place.
0
b. Amending paragraphs (e)(5) and (6), and (f)(2) by removing the term
``MAC's'' and adding ``Council's'' in its place.
0
c. Amending paragraph (a)(1) by removing the term ``hearing decision''
and adding ``ALJ's or attorney adjudicator's decision'' in its place.
0
d. Amending paragraphs (a)(1) and (b)(1) by removing the term ``ALJ
level'' and adding ``OMHA level'' in its place.
0
e. Amending paragraphs (a)(1) and (2), (b)(1) and (2), (c)(2), (c)(3)
introductory text, and (c)(3)(i) and (ii) by removing the term ``ALJ''
each time it appears and adding ``ALJ or attorney adjudicator'' in its
place.
0
f. Amending paragraphs (a) paragraph heading and (a)(1) by removing the
term ``ALJ's'' and adding ``ALJ's or attorney adjudicator's'' in its
place.
0
g. Amending paragraph (a)(2) by removing the term ``hearing record''
and adding ``administrative record'' in its place.
Sec. 405.1124 [Amended]
0
68. Section 405.1124 is amended by removing the term ``MAC'' each time
it appears and adding ``Council'' in its place.
Sec. 405.1126 [Amended]
0
69. Section 405.1126 is amended by--
0
a. Amending the section heading and paragraphs (a), (b), (c), (d)
paragraph heading, (d)(1) and (2), (e) paragraph heading, and (e)(1)
and (2) by removing the term ``MAC'' each time it appears and adding
``Council'' in its place.
0
b. Amending paragraph (b) by removing the term ``MAC's'' and adding
``Council's'' in its place.
0
c. Amending paragraphs (a), (b), (c), (d) paragraph heading, and (e)(2)
by removing the term ``ALJ'' each time it appears and adding ``ALJ or
attorney adjudicator'' in its place.
0
d. Amending paragraph (e)(2) by adding ``if applicable'' after the word
``rehearing''.
Sec. 405.1128 [Amended]
0
70. Section 405.1128 is amended by--
0
a. Amending the section heading and paragraphs (a), (b), and (c) by
removing the term ``MAC'' each time it appears and adding ``Council''
in its place.
0
b. Amending paragraph (a) by removing the term ``ALJ'' and adding ``ALJ
or attorney adjudicator'' in its place.
0
c. Amending paragraph (b) by removing the term ``ALJ hearing decision''
and adding ``ALJ's or attorney adjudicator's decision'' in its place.
Sec. 405.1130 [Amended]
0
71. Section 405.1130 is amended in the section heading and text by
removing the term ``MAC's'' each time it appears and adding
``Council's'' in its place.
Sec. 405.1132 [Amended]
0
72. Section 405.1132 is amended by--
0
a. Amending paragraphs (a) introductory text, (a)(2), and (b) by
removing the term ``MAC'' each time it appears and adding ``Council''
in its place.
0
b. Amending paragraph (b) by removing the term ``MAC's'' and adding
``Council's'' in its place.
0
c. Amending paragraphs (a) introductory text, (a)(1), and (b) by
removing the term ``ALJ'' each time it appears and adding ``ALJ or
attorney adjudicator'' in its place.
Sec. 405.1134 [Amended]
0
73. Section 405.1134 is amended by--
0
a. Amending paragraph (a) by removing the term ``MAC's'' and adding
``Council's'' in its place.
0
b. Amending paragraphs (b)(3) and (c) by removing the term ``MAC'' and
adding ``Council'' in its place.
Sec. 405.1136 [Amended]
0
74. Section 405.1136 is amended by--
0
a. Amending paragraphs (a)(1) and (2), and (c)(3) by removing the term
``MAC'' each time it appears and adding ``Council'' in its place.
0
b. Amending paragraph (a)(1) by removing the term ``ALJ's'' and adding
[[Page 43876]]
``ALJ's or attorney adjudicator's'' in its place.
0
c. Amending paragraphs (a)(2) and (c)(2) by removing the term ``MAC's''
each time it appears and adding ``Council's'' in its place.
0
d. Amending paragraph (c)(3) by removing the term ``ALJ'' and adding
``ALJ or attorney adjudicator'' in its place.
Sec. 405.1138 [Amended]
0
75. Section 405.1138 is amended by--
0
a. Removing the term ``MAC'' each time it appears and adding
``Council'' in its place.
0
b. Removing the term ``ALJ'' and adding ``ALJ or attorney adjudicator''
in its place.
Sec. 405.1140 [Amended]
0
76. Section 405.1140 is amended by--
0
a. Amending the section heading and paragraphs (a)(1), (2), and (3),
(b)(1), (2), and (3), (c) paragraph heading, (c)(1), (3), and (4), and
(d) by removing the term ``MAC'' each time it appears and adding
``Council'' in its place.
0
b. Amending the section heading and paragraphs (a)(1), (2), and (3),
(b) paragraph heading, (b)(1), (2), and (3), (c)(1) and (4), and (d) by
removing the term ``ALJ'' each time it appears and adding ``ALJ or
attorney adjudicator'' in its place.
0
c. Amending paragraph (d) by removing the term ``ALJ's'' and adding
``ALJ's or attorney adjudicator's'' in its place.
0
77. Section 405.1204 is amended by revising paragraphs (c)(4)(iii) and
(c)(5) to read as follows:
Sec. 405.1204 Expedited reconsiderations.
* * * * *
(c) * * *
(4) * * *
(iii) Information about the beneficiary's right to appeal the QIC's
reconsideration decision to OMHA for an ALJ hearing in accordance with
subpart I of this part, including how to request an appeal and the time
period for doing so.
(5) Unless the beneficiary requests an extension in accordance with
paragraph (c)(6) of this section, if the QIC does not issue a decision
within 72 hours of receipt of the request, the QIC must notify the
beneficiary of his or her right to have the case escalated to OMHA for
an ALJ hearing in accordance with subpart I of this part, if the amount
remaining in controversy after the QIO determination meets the
requirements for an ALJ hearing under Sec. 405.1006.
* * * * *
PART 422--MEDICARE ADVANTAGE PROGRAM
0
78. The authority citation for part 422 continues to read as follows:
Authority: Secs. 1102 and 1871 of the Social Security Act (42
U.S.C. 1302 and 1395hh).
Sec. 422.561 [Amended]
0
79. Section 422.561 is amended, in the definition of ``Appeal,'' by
removing the phrase ``Medicare Appeals Council (MAC)'' and adding
``Medicare Appeals Council (Council)'' in its place.
0
80. Section 422.562 is amended by--
0
a. Amending paragraph (b)(4)(v) by removing the term ``MAC'' and adding
``Council'' in its place.
0
b. Revising paragraphs (c)(1) and (d) to read as follows:
Sec. 422.562 General provisions.
* * * * *
(c) * * *
(1) If an enrollee receives immediate QIO review (as provided in
Sec. 422.622) of a determination of noncoverage of inpatient hospital
care the enrollee is not entitled to review of that issue by the MA
organization.
* * * * *
(d) When other regulations apply. Unless this subpart provides
otherwise, the regulations in part 405 of this chapter (concerning the
administrative review and hearing processes and representation of
parties under titles II and XVIII of the Act) apply under this subpart
to the extent they are appropriate, unless the part 405 regulation
implements a provision of section 1869 of the Act that is not also in
section 1852(g)(5) of the Act.
0
81. Section 422.594 is amended by revising paragraph (b)(2) to read as
follows:
Sec. 422.594 Notice of reconsidered determination by the independent
entity.
* * * * *
(b) * * *
(2) If the reconsidered determination is adverse (that is, does not
completely reverse the MA organization's adverse organization
determination), inform the parties of their right to an ALJ hearing if
the amount in controversy meets the requirements of Sec. 422.600;
* * * * *
0
82. Section 422.602 is amended by revising paragraph (b) to read as
follows:
Sec. 422.602 Request for an ALJ hearing.
* * * * *
(b) When to file a request. (1) Except when an ALJ or attorney
adjudicator extends the time frame as provided in part 405 of this
chapter, a party must file a request for a hearing within 60 calendar
days of receipt of the notice of a reconsidered determination. The time
and place for a hearing before an ALJ will be set in accordance with
Sec. 405.1020.
(2) For purposes of this section, the date of receipt of the
reconsideration is presumed to be 5 calendar days after the date of the
notice of the reconsidered determination, unless there is evidence to
the contrary.
* * * * *
0
83. Section 422.608 is revised to read as follows:
Sec. 422.608 Medicare Appeals Council (Council) review.
Any party to the ALJ's or attorney adjudicator's decision or
dismissal, including the MA organization, who is dissatisfied with the
decision or dismissal, may request that the Council review the decision
or dismissal. The regulations under part 405 of this chapter regarding
Council review apply to matters addressed by this subpart to the extent
that they are appropriate, unless the part 405 regulation implements a
provision of section 1869 of the Act that is not also in section
1852(g)(5) of the Act.
Sec. 422.612 [Amended]
0
84. Section 422.612 is amended by--
0
a. Amending paragraph (a) paragraph heading and introductory text by
removing the term ``ALJ's'' and adding ``ALJ's or attorney
adjudicator's'' in its place.
0
b. Amending paragraph (a)(1) by removing the term ``Board'' and adding
``Council'' in its place.
0
c. Amending paragraph (b) by removing the term ``MAC'' each time it
appears and adding ``Council'' in its place.
Sec. 422.616 [Amended]
0
85. Section 422.616 is amended in paragraph (a) by removing the terms
``ALJ'' and ``MAC'' and adding in their place ``ALJ or attorney
adjudicator'' and ``Council'' respectively.
Sec. 422.618 [Amended]
0
86. Section 422.618 is amended by--
0
a. Amending paragraph (c)(1) by removing the term ``ALJ'' and adding
``ALJ or attorney adjudicator'' in its place.
0
b. Amending paragraph (c)(2) by removing the terms ``Medicare Appeals
Council'', ``Medicare Appeals Council (the Board)'', and ``Board'' and
adding ``Council'' in their place.
Sec. 422.619 [Amended]
0
87. Section 422.619 is amended by--
[[Page 43877]]
0
a. Amending paragraph (c)(1) by removing the term ``ALJ'' and adding
``ALJ or attorney adjudicator'' in its place.
0
b. Amending paragraph (c)(2) by removing the terms ``Medicare Appeals
Council'', ``Medicare Appeals Council (the Board)'', and ``Board'' and
adding ``Council'' in their place.
Sec. 422.622 [Amended]
0
88. Section 422.622 (g)(2) is amended by removing the phrase ``may
appeal to an ALJ, the MAC, or a federal court'' and adding ``may appeal
to OMHA for an ALJ hearing, the Council, or a federal court'' in its
place.
Sec. 422.626 [Amended]
0
89. Section 422.626(g)(3) is amended by removing the phrase ``to an
ALJ, the MAC, or a Federal court'' and adding ``to OMHA for an ALJ
hearing, the Council, or a Federal court'' in its place.
PART 423--VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT
0
90. The authority citation for part 423 continues to read as follows:
Authority: Sections 1102, 1106, 1860D-1 through 1860D-42, and
1871 of the Social Security Act (42 U.S.C. 1302, 1306, 1395w-101
through 1395w-152, and 1395hh).
Sec. 423.560 [Amended]
0
91. Section 423.560 is amended by amending the definition of ``Appeal''
by removing the term ``Medicare Appeals Council (MAC)'' and adding
``Medicare Appeals Council (Council) in its place.
0
92. Section 423.562 is amended by revising paragraphs (b)(4)(v) and
(vi) to read as follows:
Sec. 423.562 General provisions.
* * * * *
(b) * * *
(4) * * *
(v) If the ALJ or attorney adjudicator affirms the IRE's adverse
coverage determination, in whole or in part, the right to request
Council review of the ALJ's or attorney adjudicator's decision, as
specified in Sec. 423.1974.
(vi) If the Council affirms the ALJ's or attorney adjudicator's
adverse coverage determination, in whole or in part, the right to
judicial review of the decision if the amount in controversy meets the
requirements in Sec. 423.1976.
* * * * *
Subpart U--Reopening, ALJ Hearings and ALJ and Attorney Adjudicator
Decisions, MAC Review, and Judicial Review
0
93. The heading of subpart U is revised to read as set forth above.
0
94. Section 423.1968 is revised to read as follows:
Sec. 423.1968 Scope.
This subpart sets forth the requirements relating to the following:
(a) Part D sponsors, the Part D IRE, ALJs and attorney
adjudicators, and the Council with respect to reopenings.
(b) ALJs with respect to hearings and decisions or decisions of
attorney adjudicators if no hearing is conducted.
(c) The Council with respect to review of Part D appeals.
(d) Part D enrollees' rights with respect to reopenings, ALJ
hearings and ALJ or attorney adjudicator reviews, Council reviews, and
judicial review by a Federal District Court.
0
95. Section 423.1970 is amended by revising paragraphs (c)(1)(ii) and
(iii), and (c)(2)(ii) and (iii) to read as follows:
Sec. 423.1970 Right to an ALJ hearing.
* * * * *
(c) * * *
(1) * * *
(ii) The enrollee requests aggregation at the same time the
requests for hearing are filed, and the request for aggregation and
requests for hearing are filed within 60 calendar days after receipt of
the notice of reconsideration for each of the reconsiderations being
appealed, unless the deadline to file one or more of the requests for
hearing has been extended in accordance with Sec. 423.2014(d); and
(iii) The appeals the enrollee seeks to aggregate involve the
delivery of prescription drugs to a single enrollee, as determined by
an ALJ or attorney adjudicator. Only an ALJ may determine the appeals
the enrollee seeks to aggregate do not involve the delivery of
prescription drugs to a single enrollee.
(2) * * *
(ii) The enrollees request aggregation at the same time the
requests for hearing are filed, and the request for aggregation and
requests for hearing are filed within 60 calendar days after receipt of
the notice of reconsideration for each of the reconsiderations being
appealed, unless the deadline to file one or more of the requests for
hearing has been extended in accordance with Sec. 423.2014(d); and
(iii) The appeals the enrollees seek to aggregate involve the same
prescription drugs, as determined by an ALJ or attorney adjudicator.
Only an ALJ may determine the appeals the enrollees seek to aggregate
do not involve the same prescription drugs.
0
96. Section 423.1972 is amended by revising paragraphs (a), (b), and
(c)(1) to read as follows:
Sec. 423.1972 Request for an ALJ hearing.
(a) How and where to file a request. The enrollee must file a
written request for a hearing with the OMHA office specified in the
IRE's reconsideration notice.
(b) When to file a request. (1) Except when an ALJ or attorney
adjudicator extends the timeframe as provided in Sec. 423.2014(d), the
enrollee must file a request for a hearing within 60 calendar days of
receipt of the notice of an IRE reconsideration determination. The time
and place for a hearing before an ALJ will be set in accordance with
Sec. 423.2020
(2) For purposes of this section, the date of receipt of the
reconsideration determination is presumed to be 5 calendar days after
the date of the written reconsideration determination, unless there is
evidence to the contrary.
(c) * * *
(1) If a request for a hearing clearly shows that the amount in
controversy is less than that required under Sec. 423.1970, the ALJ or
attorney adjudicator dismisses the request.
* * * * *
0
97. Section 423.1974 is revised to read as follows:
Sec. 423.1974 Council review.
An enrollee who is dissatisfied with an ALJ's or attorney
adjudicator's decision or dismissal may request that the Council review
the ALJ's or attorney adjudicator's decision or dismissal as provided
in Sec. 423.2102.
Sec. 423.1976 [Amended]
0
98. Section 423.1976 is amended by--
0
a. Amending paragraph (a) paragraph heading and introductory text by
removing the term ``ALJ's'' and adding ``ALJ's or attorney
adjudicator's'' in its place.
0
b. Amending paragraphs (a)(1) and (b) by removing the term ``MAC'' each
time it appears and adding ``Council'' in its place.
Sec. 423.1978 [Amended]
0
99. Section 423.1978(a) is amended by removing the phrase ``ALJ or the
MAC'' and adding ``ALJ or attorney adjudicator or the Council'' in its
place.
0
100. Section 423.1980 is amended by revising the section heading and
paragraphs (a)(1)(iii) and (iv), (a)(2) and (4), (d) paragraph heading,
(d)(2) and (3), (e) paragraph heading, and (e)(2) and (3) to read as
follows:
Sec. 423.1980 Reopening of coverage determinations, redeterminations,
reconsiderations, decisions, and reviews.
(a) * * *
(1) * * *
(iii) An ALJ or attorney adjudicator to revise his or her decision;
or
[[Page 43878]]
(iv) The Council to revise the ALJ or attorney adjudicator
decision, or its review decision.
(2) When an enrollee has filed a valid request for an appeal of a
coverage determination, redetermination, reconsideration, ALJ or
attorney adjudicator decision, or Council review, no adjudicator has
jurisdiction to reopen an issue that is under appeal until all appeal
rights for that issue are exhausted. Once the appeal rights for the
issue have been exhausted, the Part D plan sponsor, IRE, ALJ or
attorney adjudicator, or Council may reopen as set forth in this
section.
* * * * *
(4) Consistent with Sec. 423.1978(d), the Part D plan sponsor's,
IRE's, ALJ's or attorney adjudicator's, or Council's decision on
whether to reopen is binding and not subject to appeal.
* * * * *
(d) Time frame and requirements for reopening reconsiderations,
decisions and reviews initiated by an IRE, ALJ or attorney adjudicator,
or the Council.
* * * * *
(2) An ALJ or attorney adjudicator may reopen his or her decision,
or the Council may reopen an ALJ or attorney adjudicator decision on
its own motion within 180 calendar days from the date of the decision
for good cause in accordance with Sec. 423.1986. If the decision was
procured by fraud or similar fault, then the ALJ or attorney
adjudicator may reopen his or her decision, or the Council may reopen
an ALJ or attorney adjudicator decision at any time.
(3) The Council may reopen its review decision on its own motion
within 180 calendar days from the date of the review decision for good
cause in accordance with Sec. 423.1986. If the Council's decision was
procured by fraud or similar fault, then the Council may reopen at any
time.
(e) Time frames and requirements for reopening reconsiderations,
decisions, and reviews requested by an enrollee or a Part D plan
sponsor.
* * * * *
(2) An enrollee who received an ALJ's or attorney adjudicator's
decision or a Part D plan sponsor may request that an ALJ or attorney
adjudicator reopen his or her decision, or the Council reopen an ALJ or
attorney adjudicator decision, within 180 calendar days from the date
of the decision for good cause in accordance with Sec. 423.1986.
(3) An enrollee who received a Council decision or a Part D plan
sponsor may request that the Council reopen its decision within 180
calendar days from the date of the review decision for good cause in
accordance with Sec. 423.1986.
Sec. 423.1982 [Amended]
0
101. Section 423.1982 is amended by--
0
a. Amending paragraphs (a)(1) and (2), and (b)(1) and (2) by removing
the term ``ALJ'' and adding ``ALJ or attorney adjudicator'' in its
place.
0
b. Amending paragraphs (a)(1) and (2) and (b)(1) and (2) by removing
the term ``MAC'' and adding ``Council'' in its place.
0
102. Section 423.1984 is amended by revising paragraphs (d) and (e) to
read as follows:
Sec. 423.1984 Effect of a revised determination or decision.
* * * * *
(d) ALJ or attorney adjudicator decisions. The revision of an ALJ
or attorney adjudicator decision is binding unless an enrollee submits
a request for a Council review that is accepted and processed as
specified in Sec. 423.1974 and Sec. 423.2100 through Sec. 423.2130.
(e) Council review. The revision of a Council determination or
decision is binding unless an enrollee files a civil action in which a
Federal District Court accepts jurisdiction and issues a decision.
* * * * *
0
103. Section 423.1990 is amended by--
0
a. Amending paragraphs (a)(2), (b)(1) introductory text, (b)(1)(ii),
and (b)(4) by removing the term ``MAC'' each time it appears and adding
``Council'' in its place
0
b. Amending paragraph (d)(2)(ii) by removing the term ``MAC's'' and
adding ``Council's'' in its place.
0
c. Amending paragraph (b)(1)(i) by removing the phrase ``final
decision'' and adding ``decision'' in its place and by removing the
phrase ``order of the ALJ'' and adding ``order of the ALJ or an
attorney adjudicator'' in its place.
0
d. Amending paragraph (b)(1)(ii) by removing the term ``ALJ'' and
adding ``ALJ or attorney adjudicator'' in its place.
0
e. Amending paragraphs (c)(3), (4), and (5) by removing the term ``ALJ
hearing decision'' and adding ``ALJ or attorney adjudicator decision''
in its place.
0
f. Revising paragraph (d)(1).
0
g. Amending paragraph (d)(2)(i) by removing the term ``ALJ's'' and
adding ``ALJ's or attorney adjudicator's'' in its place.
0
h. Revising paragraph (h).
The revisions read as follows:
Sec. 423.1990 Expedited access to judicial review.
* * * * *
(d) * * *
(1) Method and place for filing request. The enrollee may--
(i) If a request for ALJ hearing or Council review is not pending,
file a written EAJR request with the HHS Departmental Appeals Board,
with his or her request for an ALJ hearing or Council review; or
(ii) If an appeal is already pending for an ALJ hearing or
otherwise before OMHA or the Council, file a written EAJR request with
the HHS Departmental Appeals Board.
* * * * *
(h) Rejection of EAJR. (1) If a request for EAJR does not meet all
the conditions set out in paragraphs (b), (c) and (d) of this section,
or if the review entity does not certify a request for EAJR, the review
entity advises the enrollee in writing that the request has been
denied, and forwards the request to OMHA or the Council, which will
treat it as a request for hearing or for Council review, as
appropriate.
(2) Whenever a review entity forwards a rejected EAJR request to
OMHA or the Council, the appeal is considered timely filed and, if an
adjudication time frame applies to the appeal, the adjudication time
frame begins on the day the request is received by OMHA or the Council
from the review entity.
0
104. Section 423.2000 is amended by revising the section heading and
paragraphs (a), (b), (c), (d), (e), and (g) to read as follows:
Sec. 423.2000 Hearing before an ALJ and decision by an ALJ or
attorney adjudicator: General rule.
(a) If an enrollee is dissatisfied with an IRE's reconsideration,
the enrollee may request a hearing before an ALJ.
(b) A hearing before an ALJ may be conducted in-person, by video-
teleconference, or by telephone. At the hearing, the enrollee may
submit evidence subject to the restrictions in Sec. 423.2018, examine
the evidence used in making the determination under review, and present
and/or question witnesses.
(c) In some circumstances, the Part D plan sponsor, CMS, or the IRE
may participate in the proceedings on a request for an ALJ hearing as
specified in Sec. 423.2010.
(d) The ALJ or attorney adjudicator conducts a de novo review and
issues a decision based on the administrative record, including, for an
ALJ, any hearing record.
(e) If an enrollee waives his or her right to appear at the hearing
in person
[[Page 43879]]
or by telephone or video-teleconference, the ALJ or an attorney
adjudicator may make a decision based on the evidence that is in the
file and any new evidence that is submitted for consideration.
* * * * *
(g) An ALJ or attorney adjudicator may also issue a decision on the
record on his or her own initiative if the evidence in the
administrative record supports a fully favorable finding.
Sec. 423.2002 [Amended]
0
105. Section 423.2002 is amended by--
0
a. Amending paragraph (a) introductory text by removing the phrase
``may request'' and adding ``has a right to'' in its place.
0
b. Amending paragraph (c) by removing the phrase ``The ALJ'' and adding
``OMHA'' in its place.
0
c. Amending paragraph (e) by removing the word ``entity'' and adding
``office'' in its place.
0
106. Section 423.2004 is amended by revising the section heading and
paragraphs (a) introductory text, (a)(1) and (4), (b), and (c) and
adding paragraph (d) to read as follows:
Sec. 423.2004 Right to a review of IRE notice of dismissal.
(a) An enrollee has a right to have an IRE's dismissal of a request
for reconsideration reviewed by an ALJ or attorney adjudicator if--
(1) The enrollee files a written request for review within 60
calendar days after receipt of the notice of the IRE's dismissal.
* * * * *
(4) For purposes of meeting the 60 calendar day filing deadline,
the request is considered as filed on the date it is received by the
office specified in the IRE's dismissal.
(b) If the ALJ or attorney adjudicator determines that the IRE's
dismissal was in error, he or she vacates the dismissal and remands the
case to the IRE for a reconsideration in accordance with Sec.
423.2056.
(c) If the ALJ or attorney adjudicator affirms the IRE's dismissal
of a reconsideration request, he or she issues a notice of decision
affirming the IRE's dismissal in accordance with Sec. 423.2046(b).
(d) The ALJ or attorney adjudicator may dismiss the request for
review of an IRE's dismissal in accordance with Sec. 423.2052(b).
0
107. Section 423.2008 is revised to read as follows:
Sec. 423.2008 Parties to the proceedings on a request for an ALJ
hearing.
The enrollee (or the enrollee's representative) who filed the
request for hearing is the only party to the proceedings on a request
for an ALJ hearing.
0
108. Section 423.2010 is revised to read as follows:
Sec. 423.2010 When CMS, the IRE, or Part D plan sponsors may
participate in the proceedings on a request for an ALJ hearing.
(a) When CMS, the IRE, or the Part D plan sponsor may participate.
(1) CMS, the IRE, and/or the Part D plan sponsor may request to
participate in the proceedings on a request for an ALJ hearing upon
filing a request to participate in accordance with paragraph (b) of
this section.
(2) An ALJ may request, but may not require, CMS, the IRE, and/or
the Part D plan sponsor to participate in any proceedings before the
ALJ, including the oral hearing, if any. The ALJ cannot draw any
adverse inferences if CMS, the IRE, and/or the Part D plan sponsor
decide not to participate in any proceedings before an ALJ, including
the hearing.
(b) How a request to participate is made--(1) No notice of hearing.
If CMS, the IRE, and/or the Part D plan sponsor requests participation
before it receives a notice of hearing, or when no notice is required,
it must send written notice of its request to participate to the
assigned ALJ or attorney adjudicator, or a designee of the Chief ALJ if
the request is not yet assigned to an ALJ or attorney adjudicator, and
the enrollee, except that the request may be made orally if a request
for an expedited hearing was filed and OMHA will notify the enrollee of
the request to participate.
(2) Notice of hearing. If CMS, the IRE, and/or the Part D plan
sponsor requests participation after the IRE and Part D plan sponsor
receive a notice of hearing, it must send written notice of its request
to participate to the ALJ and the enrollee, except that the request to
participate may be made orally for an expedited hearing and OMHA will
notify the enrollee of the request to participate.
(3) Timing of request. CMS, the IRE, and/or the Part D plan sponsor
must send its request to participate--
(i) If a standard request for hearing was filed, if no hearing is
scheduled, within 30 calendar days after notification that a standard
request for hearing was filed;
(ii) If an expedited hearing is requested, but no hearing has been
scheduled, within 2 calendar days after notification that a request for
an expedited hearing was filed.
(iii) If a non-expedited hearing is scheduled, within 5 calendar
days after receiving the notice of hearing; or
(iv) If an expedited hearing is scheduled, within 1 calendar day
after receiving the notice of hearing. Requests may be made orally or
submitted by facsimile to the hearing office.
(c) The ALJ's or attorney adjudicator's decision on a request to
participate. The assigned ALJ or attorney adjudicator has discretion
not to allow CMS, the IRE, and/or the Part D plan sponsor to
participate. The ALJ or attorney adjudicator must notify the entity
requesting participation, the Part D plan sponsor, if applicable, and
the enrollee of his or her decision on the request to participate
within the following time frames--
(1) If no hearing is scheduled, at least 20 calendar days before
the ALJ or attorney adjudicator issues a decision, dismissal, or
remand;
(2) If a non-expedited hearing is scheduled, within 5 calendar days
of receipt of a request to participate; or
(3) If an expedited hearing is scheduled, within 1 calendar of
receipt of a request to participate.
(d) Roles and responsibilities of CMS, the IRE, and/or the Part D
plan sponsor as a participant. (1) Participation may include filing
position papers and/or providing testimony to clarify factual or policy
issues in a case, but it does not include calling witnesses or cross-
examining the witnesses of an enrollee to the hearing.
(2) When CMS, the IRE, and/or the Part D plan sponsor participates
in an ALJ hearing, CMS, the IRE, and/or the Part D plan sponsor may not
be called as a witness during the hearing and is not subject to
examination or cross-examination by the enrollee, but the enrollee may
provide testimony to rebut factual or policy statements made by a
participant and the ALJ may question the participant about its
testimony.
(3) CMS, IRE, and/or Part D plan sponsor positon papers and written
testimony are subject to the following:
(i) Unless the ALJ or attorney adjudicator grants additional time
to submit a position paper or written testimony, a position paper and
written testimony must be submitted--
(A) Within 14 calendar days for a standard appeal, or 1 calendar
day for an expedited appeal, after receipt of the ALJ's or attorney
adjudicator's decision on a request to participate if no hearing has
been scheduled; or
(B) No later than 5 calendar days prior to the hearing if a non-
expedited hearing is scheduled, or 1 calendar day prior to the hearing
if an expedited hearing is scheduled.
(ii) A copy of any position paper and written testimony that CMS,
the IRE, or
[[Page 43880]]
the Part D plan sponsor submits to OMHA must be sent to the enrollee.
(iii) If CMS, the IRE, and/or the Part D plan sponsor fails to send
a copy of its position paper or written testimony to the enrollee or
fails to submit its position paper or written testimony within the time
frames described in this section, the position paper or written
testimony will not be considered in deciding the appeal.
(e) Invalid requests to participate. (1) An ALJ or attorney
adjudicator may determine that a CMS, IRE, and/or Part D plan sponsor
request to participate is invalid under this section if the request to
participate was not timely filed or the request to participate was not
sent to the enrollee.
(2) If the request to participate is determined to be invalid, the
written notice of an invalid request to participate must be sent to the
entity that made the request to participate and the enrollee.
(i) If no hearing is scheduled or the request to participate was
made after the hearing occurred, the written notice of an invalid
request to participate must be sent no later than the date the notice
of decision, dismissal, or remand is mailed.
(ii) If a non-expedited hearing is scheduled, the written notice of
an invalid request to participate must be sent prior to the hearing. If
the notice would be sent fewer than 5 calendar days before the hearing
is scheduled to occur, oral notice must be provided to the entity that
submitted the request, and the written notice must be sent as soon as
possible after the oral notice is provided.
(iii) If an expedited hearing is scheduled, oral notice of an
invalid request to participate must be provided to the entity that
submitted the request, and the written notice must be sent as soon as
possible after the oral notice is provided.
0
109. Section 423.2014 is revised to read as follows:
Sec. 423.2014 Request for an ALJ hearing or a review of an IRE
dismissal.
(a) Content of the request. (1) The request for an ALJ hearing or a
review of an IRE dismissal must be made in writing, except as set forth
in paragraph (b) of this section. The request, including any oral
request, must include all of the following--
(i) The name, address, telephone number, and Medicare health
insurance claim number of the enrollee.
(ii) The name, address, and telephone number of the appointed
representative, as defined at Sec. 423.560, if any.
(iii) The Medicare appeal number, if any, assigned to the IRE
reconsideration or dismissal being appealed.
(iv) The prescription drug in dispute.
(v) The plan name.
(vi) The reasons the enrollee disagrees with the IRE's
reconsideration or dismissal being appealed.
(vii) A statement of whether the enrollee is aware that he or she,
or the prescription for the drug being appealed, is the subject of an
investigation or proceeding by the HHS Office of Inspector General or
other law enforcement agencies.
(2) The enrollee must submit a statement of any additional evidence
to be submitted and the date it will be submitted.
(3) The enrollee must submit a statement that the enrollee is
requesting an expedited hearing, if applicable.
(b) Request for expedited hearing. If an enrollee is requesting
that the hearing be expedited, the enrollee may make the request for an
ALJ hearing orally, but only after receipt of the written IRE
reconsideration notice. OMHA must document all oral requests in writing
and maintain the documentation in the case files. A prescribing
physician or other prescriber may provide oral or written support for
an enrollee's request for expedited review.
(c) Complete request required. (1) A request must contain the
information in paragraph (a)(1) of this section to the extent the
information is applicable, to be considered complete. If a request is
not complete, the enrollee will be provided with an opportunity to
complete the request, and if an adjudication time frame applies it does
not begin until the request is complete. If the enrollee fails to
provide the information necessary to complete the request within the
time frame provided, the enrollee's request for hearing or review will
be dismissed.
(2) If supporting materials submitted with a request clearly
provide information required for a complete request, the materials will
be considered in determining whether the request is complete.
(d) When and where to file. Consistent with Sec. Sec. 423.1972(a)
and (b), the request for an ALJ hearing after an IRE reconsideration or
request for review of an IRE dismissal must be filed:
(1) Within 60 calendar days from the date the enrollee receives
written notice of the IRE's reconsideration or dismissal being
appealed.
(2) With the office specified in the IRE's reconsideration or
dismissal.
(i) If the request for hearing is timely filed with an office other
than the office specified in the IRE's reconsideration, any applicable
time frame specified in Sec. 423.2016 for deciding the appeal begins
on the date the office specified in the IRE's reconsideration or
dismissal receives the request for hearing.
(ii) If the request for hearing is filed with an office, other than
the office specified in the IRE's reconsideration or dismissal, OMHA
must notify the enrollee of the date the request was received in the
correct office and the commencement of any applicable adjudication
timeframe.
(e) Extension of time to request a hearing or review. (1)
Consistent with Sec. 423.1972(b), if the request for hearing or review
is not filed within 60 calendar days of receipt of the written IRE's
reconsideration or dismissal, an enrollee may request an extension for
good cause.
(2) Any request for an extension of time must be in writing or, for
expedited reviews, in writing or oral. OMHA must document all oral
requests in writing and maintain the documentation in the case file.
(3) The request must give the reasons why the request for a hearing
or review was not filed within the stated time period, and must be
filed with the request for hearing or review of an IRE dismissal with
the office specified in the notice of reconsideration or dismissal.
(4) An ALJ or attorney adjudicator may find there is good cause for
missing the deadline to file a request for an ALJ hearing or request
for review of an IRE dismissal, or there is no good cause for missing
the deadline to file a request for a review of an IRE dismissal, but
only an ALJ may find there is no good cause for missing the deadline to
file a request for an ALJ hearing. If good cause is found for missing
the deadline, the time period for filing the request for hearing or
request for review of an IRE dismissal will be extended. To determine
whether good cause for late filing exists, the ALJ or attorney
adjudicator uses the standards set forth in Sec. 405.942(b)(2) and (3)
of this chapter.
(5) If a request for hearing is not timely filed, any applicable
adjudication period in Sec. 423.2016 begins the date the ALJ or
attorney adjudicator grants the request to extend the filing deadline.
(6) A determination granting a request to extend the filing
deadline is not subject to further review.
0
110. Section 423.2016 is revised to read as follows:
Sec. 423.2016 Timeframes for deciding an appeal of an IRE
reconsideration.
(a) Standard appeals. (1) When a request for an ALJ hearing is
filed after an IRE has issued a written
[[Page 43881]]
reconsideration, an ALJ or attorney adjudicator issues a decision,
dismissal order, or remand, as appropriate, no later than the end of
the 90 calendar day period beginning on the date the request for
hearing is received by the office specified in the IRE's notice of
reconsideration, unless the 90 calendar day period has been extended as
provided in this subpart.
(2) The adjudication period specified in paragraph (a)(1) of this
section begins on the date that a timely filed request for hearing is
received by the office specified in the IRE's reconsideration, or, if
it is not timely filed, the date that the ALJ or attorney adjudicator
grants any extension to the filing deadline.
(3) If the Council remands a case and the case was subject to an
adjudication time frame under paragraph (a)(1) of this section, the
remanded appeal will be subject to the same adjudication time frame
beginning on the date that OMHA receives the Council remand.
(b) Expedited appeals--(1) Standard for expedited appeal. An ALJ or
attorney adjudicator issues an expedited decision if the appeal
involves an issue specified in Sec. 423.566(b), but is not solely a
request for payment of Part D drugs already furnished, and the
enrollee's prescribing physician or other prescriber indicates, or an
ALJ or attorney adjudicator determines that applying the standard
timeframe for making a decision may seriously jeopardize the enrollee's
life, health or ability to regain maximum function. An ALJ or attorney
adjudicator may consider this standard as met if a lower level
adjudicator has granted a request for an expedited hearing.
(2) Grant of a request. If an ALJ or attorney adjudicator grants a
request for expedited hearing, an ALJ or attorney adjudicator must--
(i) Make the decision to grant an expedited appeal within 5
calendar days of receipt of the request for an expedited hearing;
(ii) Give the enrollee prompt oral notice of this decision; and
(iii) Subsequently send to the enrollee at his or her last known
address and to the Part D plan sponsor written notice of the decision.
This notice may be provided within the written notice of hearing.
(3) Denial of a request. If an ALJ or attorney adjudicator denies a
request for expedited hearing, an ALJ or attorney adjudicator must--
(i) Make this decision within 5 calendar days of receipt of the
request for expedited hearing;
(ii) Give the enrollee prompt oral notice of the denial that
informs the enrollee of the denial and explains that an ALJ or attorney
adjudicator will process the enrollee's request using the 90 calendar
day timeframe for non-expedited appeals; and
(iii) Subsequently send to the enrollee at his or her last known
address and to the Part D plan sponsor an equivalent written notice of
the decision within 3 calendar days after the oral notice.
(4) Decision not appealable. A decision on a request for expedited
hearing may not be appealed.
(5) Time frame for adjudication. (i) If an ALJ or attorney
adjudicator accepts a request for expedited hearing, an ALJ or attorney
adjudicator issues a written decision, dismissal order, or remand as
expeditiously as the enrollee's health condition requires, but no later
than the end of the 10 calendar day period beginning on the date the
request for hearing is received by the office specified in the IRE's
written notice of reconsideration, unless the 10 calendar day period
has been extended as provided in this subpart.
(ii) The adjudication period specified in paragraph (b)(5)(i) of
this section begins on the date that a timely provided request for
hearing is received by the office specified in the IRE's
reconsideration, or, if it is not timely provided, the date that an ALJ
or attorney adjudicator grants any extension to the filing deadline.
(6) Time frame for Council remands. If the Council remands a case
and the case was subject to an adjudication time frame under paragraph
(b)(5) of this section, the remanded appeal will be subject to the same
adjudication timeframe beginning on the date that OMHA receives the
Council remand, if the standards for an expedited appeal continue to be
met. If the standards for an expedited appeal are no longer met, the
appeal will be subject to the adjudication time frame for a standard
appeal.
(c) Waivers and extensions of adjudication period. (1) At any time
during the adjudication process, the enrollee may waive the
adjudication period specified in paragraphs (a)(1) and (b)(5) of this
section. The waiver may be for a specific period of time agreed upon by
the ALJ or attorney adjudicator and the enrollee.
(2) The adjudication periods specified in paragraphs (a)(1) and
(b)(5) of this section are extended as otherwise specified in this
subpart, and for the following events--
(i) The duration of a stay of action on adjudicating the matters at
issue ordered by a court or tribunal of competent jurisdiction;
(ii) The duration of a stay of proceedings granted by an ALJ or
attorney adjudicator on a motion by an enrollee.
0
111. Section 423.2018 is revised to read as follows:
Sec. 423.2018 Submitting evidence.
(a) All appeals. An enrollee must submit any written or other
evidence that he or she wishes to have considered.
(1) An ALJ or attorney adjudicator will not consider any evidence
submitted regarding a change in condition of an enrollee after the
appealed coverage determination was made.
(2) An ALJ or attorney adjudicator will remand a case to the Part D
IRE where an enrollee wishes evidence on his or her change in condition
after the coverage determination to be considered.
(b) Non-expedited appeals. (1) Except as provided in this
paragraph, a represented enrollee must submit all written or other
evidence he or she wishes to have considered with the request for
hearing by the date specified in the request for hearing in accordance
with Sec. 423.2014(a)(2), or, if a hearing is scheduled, within 10
calendar days of receiving the notice of hearing.
(2) If a represented enrollee submits written or other evidence
later than 10 calendar days after receiving the notice of hearing, any
applicable adjudication period specified in Sec. 423.2016 is extended
by the number of calendar days in the period between 10 calendar days
after receipt of the notice of hearing and the day the evidence is
received.
(3) The requirements of paragraph (b) of this section do not apply
to unrepresented enrollees.
(c) Expedited appeals. (1) Except as provided in this section, an
enrollee must submit all written or other evidence he or she wishes to
have considered with the request for hearing by the date specified in
the request for hearing pursuant to Sec. 423.2014(a)(2), or, if an
expedited hearing is scheduled, within 2 calendar days of receiving the
notice of the expedited hearing.
(2) If an enrollee submits written or other evidence later than 2
calendar days after receiving the notice of expedited hearing, any
applicable adjudication period specified in Sec. 423.2016 is extended
by the number of calendar days in the period between 2 calendar days
after receipt of the notice of expedited hearing and the day the
evidence is received.
(d) When this section does not apply. The requirements of
paragraphs (b) and (c) of this section do not apply to oral testimony
given at a hearing.
[[Page 43882]]
0
112. Section 423.2020 is amended by
0
a. Revising paragraphs (b), (c), (d), and (e)(3) and (4).
0
b. Adding paragraphs (g)(3)(vii) and (viii).
0
c. Revising paragraphs (h), (i) paragraph heading, and (i)(1), (2),
(4), and (5).
0
d. Adding paragraph (j).
The revisions and additions read as follows:
Sec. 423.2020 Time and place for a hearing before an ALJ.
* * * * *
(b) Determining how appearances are made. (1) Appearances by
unrepresented enrollees. The ALJ will direct that the appearance of an
unrepresented enrollee who filed a request for hearing be conducted by
video-teleconferencing if the ALJ finds that video-teleconferencing
technology is available to conduct the appearance, unless the ALJ finds
good cause for an in-person appearance.
(i) The ALJ may also offer to conduct a hearing by telephone if the
request for hearing or administrative record suggests that a telephone
hearing may be more convenient for the unrepresented enrollee.
(ii) The ALJ, with the concurrence of the Chief ALJ or designee,
may find good cause that an in-person hearing should be conducted if--
(A) The video-teleconferencing or telephone technology is not
available; or
(B) Special or extraordinary circumstances exist.
(2) Appearances by represented enrollees. The ALJ will direct that
the appearance of an individual, other than an unrepresented enrollee
who filed a request for hearing, be conducted by telephone, unless the
ALJ finds good cause for an appearance by other means.
(i) The ALJ may find good cause for an appearance by video-
teleconferencing if he or she determines that video-teleconferencing is
necessary to examine the facts or issues involved in the appeal.
(ii) The ALJ, with the concurrence of the Chief ALJ or designee,
may find good cause that an in-person hearing should be conducted if--
(A) The video-teleconferencing or telephone technology is not
available; or
(B) Special or extraordinary circumstances exist.
(c) Notice of hearing. (1) A notice of hearing is sent to the
enrollee, the Part D plan sponsor that issued the coverage
determination, and the IRE that issued the reconsideration, advising
them of the proposed time and place of the hearing.
(2) The notice of hearing will require the enrollee to reply to the
notice by:
(i) Acknowledging whether they plan to attend the hearing at the
time and place proposed in the notice of hearing, or whether they
object to the proposed time and/or place of the hearing;
(ii) If the representative is an entity or organization, specifying
who from the entity or organization plans to attend the hearing, if
anyone, and in what capacity, in addition to the individual who filed
the request for hearing; and
(iii) Listing the witnesses who will be providing testimony at the
hearing.
(3) The notice of hearing will require CMS, the IRE, or the Part D
plan sponsor that requests to attend the hearing as a participant to
reply to the notice by:
(i) Acknowledging whether it plans to attend the hearing at the
time and place proposed in the notice of hearing; and
(ii) Specifying who from the entity plans to attend the hearing,
(d) An enrollee's right to waive a hearing. An enrollee may also
waive the right to a hearing and request a decision based on the
written evidence in the record in accordance with Sec. 423.2038(b).
(1) As specified in Sec. 423.2000, an ALJ may require the enrollee
to attend a hearing if it is necessary to decide the case.
(2) If an ALJ determines that it is necessary to obtain testimony
from a person other than the enrollee, he or she may still hold a
hearing to obtain that testimony, even if the enrollee has waived the
right to appear. In those cases, the ALJ would give the enrollee the
opportunity to appear when the testimony is given but may hold the
hearing even if the enrollee decides not to appear.
* * * * *
(e) * * *
(3) The objection must be in writing except for an expedited
hearing when the objection may be provided orally, and except that the
enrollee may orally request that a non-expedited hearing be rescheduled
in an emergency circumstance the day prior to or day of the hearing.
The ALJ must document all oral objections to the time and place of a
hearing in writing and maintain the documentation in the case files.
(4) The ALJ may change the time or place of the hearing if the
enrollee has good cause.
* * * * *
(g) * * *
(3) * * *
(vii) The enrollee or enrollee's representative has a prior
commitment that cannot be changed without significant expense.
(viii) The enrollee or enrollee's representative asserts he or she
did not receive the notice of hearing and is unable to appear at the
scheduled time and place.
(h) Effect of rescheduling hearing. If a hearing is postponed at
the request of the enrollee for any of the above reasons, the time
between the originally scheduled hearing date and the new hearing date
is not counted toward the adjudication period specified in Sec.
423.2016.
(i) An enrollee's request for an in-person or video-
teleconferencing hearing. (1) If an unrepresented enrollee objects to a
video-teleconferencing hearing or to the ALJ's offer to conduct a
hearing by telephone, or a represented enrollee who filed the request
for hearing objects to a telephone or video-teleconferencing hearing,
the enrollee or the enrollee's representative must notify the ALJ at
the earliest possible opportunity before the time set for the hearing
and request a video-teleconferencing or an in-person hearing.
(2) The enrollee must state the reason for the objection and state
the time and/or place he or she wants an in-person or video-
teleconferencing hearing to be held.
* * * * *
(4) When an enrollee's request for an in-person or video-
teleconferencing hearing is granted and an adjudication time frame
applies in accordance with Sec. 423.2016, the ALJ issues a decision,
dismissal, or remand to the IRE within the adjudication time frame
specified in Sec. 423.2016 (including any applicable extensions
provided in this subpart), unless the enrollee requesting the hearing
agrees to waive such adjudication timeframe in writing.
(5) The ALJ may grant the request, with the concurrence of the
Chief ALJ or designee, upon a finding of good cause and will reschedule
the hearing for a time and place when the enrollee may appear in person
or by video-teleconference before the ALJ.
(j) Amended notice of hearing. If the ALJ changes or will change
the time and/or place of the hearing, an amended notice of hearing must
be sent to the enrollee and CMS, the IRE, and/or the Part D plan
sponsor in accordance with Sec. 423.2022(a)(2).
0
113. Section 423.2022 is revised to read as follows:
Sec. 423.2022 Notice of a hearing before an ALJ.
(a) Issuing the notice. (1) After the ALJ sets the time and place
of the hearing, the notice of the hearing will be mailed or otherwise
transmitted in accordance with OMHA procedures to the enrollee and
other potential participants, as provided in Sec. 423.2020(c) at their
last
[[Page 43883]]
known addresses, or given by personal service, except to an enrollee or
other potential participant who indicates in writing that he or she
does not wish to receive this notice.
(2) The notice is mailed, transmitted, or served at least 20
calendar days before the hearing, except for expedited hearings where
written notice is mailed, transmitted, or served at least 3 calendar
days before the hearing, unless the enrollee or other potential
participant agrees in writing to the notice being mailed, transmitted,
or served fewer than 20 calendar days before the non-expedited hearing
or 3 calendar days before the expedited hearing. For expedited
hearings, the ALJ may orally provide notice of the hearing to the
enrollee and other potential participants but oral notice must be
followed by an equivalent written notice within 1 calendar day of the
oral notice.
(b) Notice information. (1) The notice of hearing contains--
(i) A statement that the issues before the ALJ include all of the
issues brought out in the coverage determination, redetermination, or
reconsideration that were not decided entirely in the enrollee's favor
and that were specified in the request for hearing; and
(ii) A statement of any specific new issues the ALJ will consider
in accordance with Sec. 423.2032.
(2) The notice will inform the enrollee that he or she may
designate a person to represent him or her during the proceedings.
(3) The notice must include an explanation of the procedures for
requesting a change in the time or place of the hearing, a reminder
that the ALJ may dismiss the hearing request if the enrollee fails to
appear at the scheduled hearing without good cause, and other
information about the scheduling and conduct of the hearing.
(4) The enrollee will also be told if his or her appearance or that
of any other witness is scheduled by video-teleconferencing, telephone,
or in person. If the ALJ has scheduled the enrollee to appear at the
hearing by video-teleconferencing, the notice of hearing will advise
that the scheduled place for the hearing is a video-teleconferencing
site and explain what it means to appear at the hearing by video-
teleconferencing.
(5) The notice advises the enrollee that if he or she objects to
appearing by video-teleconferencing or telephone, and wishes instead to
have his or her hearing at a time and place where he or she may appear
in person before the ALJ, he or she must follow the procedures set
forth at Sec. 423.2020(i) for notifying the ALJ of his or her
objections and for requesting an in-person hearing.
(c) Acknowledging the notice of hearing. (1) If the enrollee or his
or her representative does not acknowledge receipt of the notice of
hearing, OMHA attempts to contact the enrollee for an explanation.
(2) If the enrollee states that he or she did not receive the
notice of hearing, a copy of the notice is sent to him or her by
certified mail or other means requested by the enrollee and in
accordance with OMHA procedures.
(3) The enrollee may request that the ALJ reschedule the hearing in
accordance with Sec. 423.2020(e).
0
114. Section 423.2024 is amended by--
0
a. Amending paragraph (a) by removing the phrase ``The ALJ hearing
office'' and adding ``OMHA'' in its place.
0
b. Revising paragraph (c) to read as follows:
Sec. 423.2024 Objections to the issues.
* * * * *
(c) The ALJ makes a decision on the objections either in writing,
at a prehearing conference, or at the hearing.
0
115. Section 423.2026 is revised to read as follows:
Sec. 423.2026 Disqualification of the ALJ or attorney adjudicator.
(a) An ALJ or attorney adjudicator may not adjudicate an appeal if
he or she is prejudiced or partial to the enrollee or has any interest
in the matter pending for decision.
(b) If an enrollee objects to the ALJ or attorney adjudicator
assigned to adjudicate the appeal, the enrollee must notify the ALJ
within 10 calendar days of the date of the notice of hearing if a non-
expedited hearing is scheduled, except for expedited hearings in which
the enrollee must submit written or oral notice no later than 2
calendar days after the date of the notice of hearing, or the ALJ or
attorney adjudicator at any time before a decision, dismissal order, or
remand order is issued if no hearing is scheduled. The ALJ or attorney
adjudicator must document all oral objections in writing and maintain
the documentation in the case files. The ALJ or attorney adjudicator
considers the enrollee's objections and decides whether to proceed with
the appeal or withdraw.
(c) If the ALJ or attorney adjudicator withdraws, another ALJ or
attorney adjudicator will be assigned to adjudicate the appeal. If the
ALJ or attorney adjudicator does not withdraw, the enrollee may, after
the ALJ or attorney adjudicator has issued an action in the case,
present his or her objections to the Council in accordance with Sec.
423.2100 through Sec. 423.2130. The Council will then consider whether
the decision or dismissal should be revised or, if applicable, a new
hearing held before another ALJ.
(d) If the enrollee objects to the ALJ or attorney adjudicator and
the ALJ or attorney adjudicator subsequently withdraws from the appeal,
any adjudication period that applies to the appeal in accordance with
Sec. 423.2016 is extended by 14 calendar days for a standard appeal,
or 2 calendar days for an expedited appeal.
0
116. Section 423.2030 is revised to read as follows:
Sec. 423.2030 ALJ hearing procedures.
(a) General rule. A hearing is open to the enrollee and to other
persons the ALJ considers necessary and proper.
(b) At the hearing. (1) The ALJ fully examines the issues,
questions the enrollee and other witnesses, and may accept evidence
that is material to the issues consistent with Sec. 423.2018.
(2) The ALJ may limit testimony and argument at the hearing that
are not relevant to an issue before the ALJ, or that address an issue
before the ALJ for which the ALJ determines he or she has sufficient
information or on which the ALJ has already ruled. The ALJ may, but is
not required to, provide the enrollee or representative with an
opportunity to submit additional written statements and affidavits on
the matter in lieu of testimony and/or argument at the hearing. The
written statements and affidavits must be submitted within the time
frame designated by the ALJ.
(3) If the ALJ determines that the enrollee or enrollee's
representative is uncooperative, disruptive to the hearing, or abusive
during the course of the hearing, the ALJ may excuse the enrollee or
representative from the hearing and continue with the hearing to
provide the participants with an opportunity to offer testimony and/or
argument. If an enrollee or representative was excused from the
hearing, the ALJ will provide the enrollee or representative with an
opportunity to submit written statements and affidavits in lieu of
testimony and/or argument at the hearing, and the enrollee or
representative may request a recording of the hearing in accordance
with Sec. 423.2042 and respond in writing to any statements made by
participants and/or testimony of the witnesses at the hearing. The
written statements and affidavits must be submitted within the time
frame designated by the ALJ.
[[Page 43884]]
(c) Missing evidence. The ALJ may also stop the hearing temporarily
and continue it at a later date if he or she believes that there is
material evidence missing at the hearing.
(d) Effect of new evidence on adjudication period. If an enrollee,
other than an unrepresented enrollee in a standard appeal, submits
evidence pursuant to paragraph (b) or (c), and an adjudication period
applies to the appeal, the adjudication period specified in Sec.
423.2016 is extended in accordance with Sec. 423.2018(b) or (c), as
applicable.
(e) Continued hearing. (1) A hearing may be continued to a later
date. Notice of the continued hearing must be sent in accordance with
Sec. 423.2022, except that a waiver of notice of the hearing may be
made in writing or on the record, and the notice is sent to the
enrollee and participants who attended the hearing, and any additional
potential participants the ALJ determines are appropriate.
(2) If the enrollee requests the continuance and an adjudication
time frame applies to the appeal in accordance with Sec. 423.2016, the
adjudication period is extended by the period between the initial
hearing date and the continued hearing date.
(f) Supplemental hearing. (1) The ALJ may conduct a supplemental
hearing at any time before he or she mails a notice of the decision in
order to receive new and material evidence, obtain additional
testimony, or address a procedural matter. The ALJ determines whether a
supplemental hearing is necessary and if one is held, the scope of the
hearing, including when evidence is presented and what issues are
discussed. Notice of the supplemental hearing must be sent in
accordance with Sec. 423.2022, except that the notice is sent to the
enrollee and participants who attended the hearing, and any additional
potential participants the ALJ determines are appropriate.
(2) If the enrollee requests the supplemental hearing and an
adjudication period applies to the appeal in accordance with Sec.
423.2016, the adjudication period is extended by the period between the
initial hearing date and the supplemental hearing date.
0
117. Section 423.2032 is revised to read as follows:
Sec. 423.2032 Issues before an ALJ or attorney adjudicator.
(a) General rule. The issues before the ALJ or attorney adjudicator
include all the issues for the appealed matter specified in the request
for hearing that were brought out in the coverage determination,
redetermination, or reconsideration that were not decided entirely in
an enrollee's favor.
(b) New issues--(1) When a new issue may be considered. A new issue
may include issues resulting from the participation of CMS, the IRE, or
the Part D plan sponsor at the OMHA level of adjudication and from any
evidence and position papers submitted by CMS, the IRE, or the Part D
plan sponsor for the first time to the ALJ. The ALJ or the enrollee may
raise a new issue; however, the ALJ may only consider a new issue
relating to a determination or appealed matter specified in the request
for hearing, including a favorable portion of a determination or
appealed matter specified in the request for hearing, if its resolution
could have a material impact on the appealed matter and--
(i) There is new and material evidence that was not available or
known at the time of the determination and that may result in a
different conclusion; or
(ii) The evidence that was considered in making the determination
clearly shows on its face that an obvious error was made at the time of
the determination.
(2) Notice of the new issue. The ALJ may consider a new issue at
the hearing if he or she notifies the enrollee about the new issue
before the start of the hearing.
(3) Opportunity to submit evidence. If notice of the new issue is
sent after the notice of hearing, the enrollee will have at least 10
calendar days in standard appeals or 2 calendar days in expedited
appeals after receiving notice of the new issue to submit evidence
regarding the issue, and without affecting any applicable adjudication
period. If a hearing is conducted before the time to submit evidence
regarding the issue expires, the record will remain open until the
opportunity to submit evidence expires.
(c) Adding coverage determinations to a pending appeal. A coverage
determination on a drug that was not specified in a request for hearing
may only be added to pending appeal if the coverage determination was
adjudicated in the same reconsideration that is appealed, and the
period to request an ALJ hearing for that reconsideration has not
expired, or an ALJ or attorney adjudicator extends the time to request
an ALJ hearing on the reconsideration in accordance with Sec.
423.2014(e).
0
118. Section 423.2034 is revised to read as follows:
Sec. 423.2034 Requesting information from the IRE.
(a) If an ALJ or attorney adjudicator believes that the written
record is missing information that is essential to resolving the issues
on appeal and that information can be provided only by CMS, the IRE,
and/or the Part D plan sponsor, the information may be requested from
the IRE that conducted the reconsideration or its successor.
(1) Official copies of redeterminations and reconsiderations that
were conducted on the appealed issues can only be provided by CMS, the
IRE, and/or the Part D plan sponsor.
(2) ``Can be provided only by CMS, the IRE, and/or the Part D plan
sponsor'' means the information is not publicly available, is not in
the possession of the enrollee, and cannot be requested and obtained by
the enrollee. Information that is publicly available is information
that is available to the general public via the Internet or in a
printed publication. Information that is publicly available includes,
but is not limited to, information available on a CMS, IRE or Part D
Plan sponsor Web site or information in an official CMS or HHS
publication.
(b) The ALJ or attorney adjudicator retains jurisdiction of the
case, and the case remains pending at OMHA.
(c) The IRE has 15 calendar days for standard appeals, or 2
calendar days for expedited appeals, after receiving the request for
information to furnish the information or otherwise respond to the
information request directly or through CMS or the Part D plan sponsor.
(d) If an adjudication period applies to the appeal in accordance
with Sec. 423.2016, the adjudication period is extended by the period
between the date of the request for information and the date the IRE
responds to the request or 20 calendar days after the date of the
request for standard appeals, or 3 calendar days after the date of the
request for expedited appeals, whichever occurs first.
Sec. 423.2036 [Amended]
0
119. Section 423.2036 is amended by--
0
a. Amending paragraph (b)(1) introductory text by removing the phrase
``send the ALJ'' and adding ``submit to OMHA'' in its place.
0
b. Amending paragraph (b)(1)(ii) by removing the phrase ``The ALJ
hearing office'' and adding ``OMHA'' in its place.
0
c. Removing paragraph (d).
0
d. Redesignating paragraph (g) as new paragraph (d).
0
e. Amending paragraphs (f)(2), (f)(3) introductory text, and (f)(3)
(i), (ii), and (iii) by removing the term ``MAC'' and adding
``Council'' in its place.
[[Page 43885]]
0
f. Amending paragraph (f)(2) by removing the term ``MAC's'' and adding
``Council's'' in its place.
0
120. Section 423.2038 is revised to read as follows:
Sec. 423.2038 Deciding a case without a hearing before an ALJ.
(a) Decision fully favorable. If the evidence in the administrative
record supports a finding fully in favor of the enrollee(s) on every
issue, the ALJ or attorney adjudicator may issue a decision without
giving the enrollee(s) prior notice and without an ALJ conducting a
hearing. The notice of the decision informs the enrollee(s) that he or
she has the right to a hearing and a right to examine the evidence on
which the decision is based.
(b) Enrollee does not wish to appear. (1) The ALJ or attorney
adjudicator may decide a case on the record and without an ALJ
conducting a hearing if--
(i) The enrollee indicates in writing or, for expedited hearings
orally or in writing, that he or she does not wish to appear before an
ALJ at a hearing, including a hearing conducted by telephone or video-
teleconferencing, if available. OMHA must document all oral requests
not to appear at a hearing in writing and maintain the documentation in
the case files; or
(ii) The enrollee lives outside the United States and does not
inform OMHA that he or she wants to appear at a hearing before an ALJ.
(2) When a hearing is not held, the decision of the ALJ or attorney
adjudicator must refer to the evidence in the record on which the
decision was based.
(c) Stipulated decision. If CMS, the IRE, and/or the Part D plan
sponsor submits a written statement or makes an oral statement at a
hearing indicating the drug should be covered or payment may be made,
an ALJ or attorney adjudicator may issue a stipulated decision finding
in favor of the enrollee on the basis of the statement, and without
making findings of fact, conclusions of law, or further explaining the
reasons for the decision.
0
121. Section 423.2040 is revised to read as follows:
Sec. 423.2040 Prehearing and posthearing conferences.
(a) The ALJ may decide on his or her own, or at the request of the
enrollee to the hearing, to hold a prehearing or posthearing conference
to facilitate the hearing or the hearing decision.
(b) For non-expedited hearings, the ALJ informs the enrollee, and
CMS, the IRE, and/or the Part D plan sponsor if the ALJ has granted
their request(s) to be a participant to the hearing at the time the
notice of conference is sent, of the time, place, and purpose of the
conference at least 7 calendar days before the conference date, unless
the enrollee indicates in writing that he or she does not wish to
receive a written notice of the conference.
(c) For expedited hearings, the ALJ informs the enrollee, and CMS,
the IRE, and/or the Part D plan sponsor if the ALJ has granted their
request(s) to be a participant to the hearing, of the time, place, and
purpose of the conference at least 2 calendar days before the
conference date, unless the enrollee indicates orally or in writing
that he or she does not wish to receive a written notice of the
conference.
(d) All oral requests not to receive written notice of the
conference must be documented in writing and the documentation must be
made part of the administrative record.
(e) At the conference--
(1) The ALJ or an OMHA attorney designated by the ALJ conducts the
conference, but only the ALJ conducting a conference may consider
matters in addition to those stated in the conference notice, if the
enrollee consents to consideration of the additional matters in
writing.
(2) An audio recording of the conference is made.
(f) The ALJ issues an order to the enrollee and all participants
who attended the conference stating all agreements and actions
resulting from the conference. If the enrollee does not object within
10 calendar days of receiving the order for non-expedited hearings or 1
calendar day for expedited hearings, or any additional time granted by
the ALJ, the agreements and actions become part of the administrative
record and are binding on the enrollee.
0
122. Section 423.2042 is revised to read as follows:
Sec. 423.2042 The administrative record.
(a) Creating the record. (1) OMHA makes a complete record of the
evidence and administrative proceedings on the appealed matter,
including any prehearing and posthearing conference and hearing
proceedings that were conducted.
(2) The record will include marked as exhibits, the appealed
determinations and documents and other evidence used in making the
appealed determinations and the ALJ's or attorney adjudicator's
decision, including, but not limited to, medical records, written
statements, certificates, reports, affidavits, and any other evidence
the ALJ or attorney adjudicator admits. The record will also include
any evidence excluded or not considered by the ALJ or attorney
adjudicator, including but not limited to duplicative evidence
submitted by the enrollee.
(3) An enrollee may request and receive a copy of the record prior
to or at the hearing, or, if a hearing is not held, at any time before
the notice of decision is issued.
(4) If a request for review is filed, the complete record,
including any prehearing and posthearing conference and hearing
recordings, is forwarded to the Council.
(5) A typed transcription of the hearing is prepared if an enrollee
seeks judicial review of the case in a Federal district court within
the stated time period and all other jurisdictional criteria are met,
unless, upon the Secretary's motion prior to the filing of an answer,
the court remands the case.
(b) Requesting and receiving copies of the record. (1) While an
appeal is pending at OMHA, an enrollee may request and receive a copy
of all or part of the record from OMHA, including any index of the
administrative record, documentary evidence, and a copy of the audio
recording of the oral proceedings. The enrollee may be asked to pay the
costs of providing these items.
(2) If an enrollee requests a copy of all or part of the record
from OMHA or the ALJ or attorney adjudicator and an opportunity to
comment on the record, any adjudication period that applies in
accordance with Sec. 423.2016 is extended by the time beginning with
the receipt of the request through the expiration of the time granted
for the enrollee's response.
(3) If the enrollee requests a copy of all or part of the record
and the record, including any audio recordings, contains information
pertaining to an individual that the enrollee is not entitled to
receive, such as personally identifiable information or protected
health information, such portions of the record will not be furnished
unless the enrollee obtains consent from the individual.
0
123. Section 423.2044 is revised to read as follows:
Sec. 423.2044 Consolidated proceedings.
(a) Consolidated hearing. (1) A consolidated hearing may be held if
one or more of the issues to be considered at the hearing are the same
issues that are involved in one or more other appeals pending before
the same ALJ.
(2) It is within the discretion of the ALJ to grant or deny an
enrollee's request for consolidation. In considering an enrollee's
request, the ALJ may consider factors such as whether the
[[Page 43886]]
issue(s) may be more efficiently decided if the appeals are
consolidated for hearing. In considering the enrollee's request for
consolidation, the ALJ must take into account any adjudication
deadlines for each appeal and may require an enrollee to waive the
adjudication deadline associated with one or more appeals if
consolidation otherwise prevents the ALJ from deciding all of the
appeals at issue within their respective deadlines.
(3) The ALJ may also propose on his or her own motion to
consolidate two or more appeals in one hearing for administrative
efficiency, but may not require an enrollee to waive the adjudication
deadline for any of the consolidated cases.
(4) Notice of a consolidated hearing must be included in the notice
of hearing issued in accordance with Sec. Sec. 423.2020 and 423.2022.
(b) Consolidated decision and record. (1) If the ALJ decides to
hold a consolidated hearing, he or she may make either--
(i) A consolidated decision and record; or
(ii) A separate decision and record on each appeal.
(2) If a separate decision and record on each appeal is made, the
ALJ is responsible for making sure that any evidence that is common to
all appeals and material to the common issue to be decided, and audio
recordings of any conferences that were conducted and the consolidated
hearing are included in each individual administrative record, as
applicable.
(3) If a hearing will not be conducted for multiple appeals that
are before the same ALJ or attorney adjudicator, and the appeals
involve one or more of the same issues, the ALJ or attorney adjudicator
may make a consolidated decision and record at the request of the
enrollee or on the ALJ's or attorney adjudicator's own motion.
(c) Limitation on consolidated proceedings. Consolidated
proceedings may only be conducted for appeals filed by the same
enrollee, unless multiple enrollees aggregated appeals to meet the
amount in controversy requirement in accordance with Sec. 423.1970 and
the enrollees have all authorized disclosure of information to the
other enrollees.
0
124. Section 423.2046 is revised to read as follows:
Sec. 423.2046 Notice of an ALJ or attorney adjudicator decision.
(a) Decisions on requests for hearing--(1) General rule. Unless the
ALJ or attorney adjudicator dismisses or remands the request for
hearing, the ALJ or attorney adjudicator will issue a written decision
that gives the findings of fact, conclusions of law, and the reasons
for the decision.
(i) The decision must be based on evidence offered at the hearing
or otherwise admitted into the record, and shall include independent
findings and conclusions.
(ii) A copy of the decision should be mailed or otherwise
transmitted to the enrollee at his or her last known address.
(iii) A copy of the written decision should also be provided to the
IRE that issued the reconsideration determination, and to the Part D
plan sponsor that issued the coverage determination.
(2) Content of the notice. The decision must be provided in a
manner calculated to be understood by an enrollee and must include--
(i) The specific reasons for the determination, including, to the
extent appropriate, a summary of any clinical or scientific evidence
used in making the determination;
(ii) The procedures for obtaining additional information concerning
the decision; and
(iii) Notification of the right to appeal the decision to the
Council, including instructions on how to initiate an appeal under this
section.
(3) Limitation on decision. When the amount of payment for the Part
D drug is an issue before the ALJ or attorney adjudicator, the ALJ or
attorney adjudicator may make a finding as to the amount of payment
due. If the ALJ or attorney adjudicator makes a finding concerning
payment when the amount of payment was not an issue before the ALJ or
attorney adjudicator, the Part D plan sponsor may independently
determine the payment amount. In either of the aforementioned
situations, an ALJ's or attorney adjudicator's decision is not binding
on the Part D plan sponsor for purposes of determining the amount of
payment due. The amount of payment determined by the Part D plan
sponsor in effectuating the ALJ's or attorney adjudicator's decision is
a new coverage determination under Sec. 423.566.
(b) Decisions on requests for review of an IRE dismissal--(1)
General rule. Unless the ALJ or attorney adjudicator dismisses the
request for review of an IRE dismissal, or the dismissal is vacated and
remanded, the ALJ or attorney adjudicator will issue a written decision
affirming the IRE's dismissal. OMHA mails or otherwise transmits a copy
of the decision to the enrollee.
(2) Content of the notice. The decision must be written in a manner
calculated to be understood by an enrollee and must include--
(i) The specific reasons for the determination, including a summary
of the evidence considered and applicable authorities;
(ii) The procedures for obtaining additional information concerning
the decision; and
(iii) Notification that the decision is binding and is not subject
to further review, unless reopened and revised by the ALJ or attorney
adjudicator.
(c) Recommended decision. An ALJ or attorney adjudicator issues a
recommended decision if he or she is directed to do so in the Council's
remand order. An ALJ or attorney adjudicator may not issue a
recommended decision on his or her own motion. The ALJ or attorney
adjudicator mails a copy of the recommended decision to the enrollee at
his or her last known address.
0
125. Section 423.2048 is revised to read as follows:
Sec. 423.2048 The effect of an ALJ's or attorney adjudicator's
decision.
(a) The decision of the ALJ or attorney adjudicator on a request
for hearing is binding unless--
(1) An enrollee requests a review of the decision by the Council
within the stated time period or the Council reviews the decision
issued by an ALJ or attorney adjudicator under the procedures set forth
in Sec. 423.2110, and the Council issues a final decision or remand
order;
(2) The decision is reopened and revised by an ALJ or attorney
adjudicator or the Council under the procedures explained in Sec.
423.1980;
(3) The expedited access to judicial review process at Sec.
423.1990 is used;
(4) The ALJ's or attorney adjudicator's decision is a recommended
decision directed to the Council and the Council issues a decision; or
(5) In a case remanded by a Federal district court, the Council
assumes jurisdiction under the procedures in Sec. 423.2138 and the
Council issues a decision.
(b) The decision of the ALJ or attorney adjudicator on a request
for review of an IRE dismissal is binding on the enrollee unless the
decision is reopened and revised by the ALJ or attorney adjudicator
under the procedures explained in Sec. 423.1980.
Sec. 423.2050 [Amended]
0
126. Section 423.2050 is amended by--
0
a. Amending the section heading by removing the phrase ``an ALJ'' and
adding ``OMHA'' in its place.
[[Page 43887]]
0
b. Amending the text of the section by removing the phrase ``pending
before an ALJ'' and adding ``pending before OMHA'' in its place, and by
removing the term ``the ALJ'' and adding ``OMHA'' in its place.
0
c. Amending the section heading and the text of the section by removing
the term ``MAC'' each time it appears and adding ``Council'' in its
place.
0
127. Section 423.2052 is revised to read as follows:
Sec. 423.2052 Dismissal of a request for a hearing before an ALJ or
request for review of an IRE dismissal.
(a) Dismissal of request for hearing. An ALJ dismisses a request
for a hearing under any of the following conditions:
(1) Neither the enrollee that requested the hearing nor the
enrollee's representative appears at the time and place set for the
hearing, if--
(i) The enrollee was notified before the time set for the hearing
that the request for hearing might be dismissed for failure to appear,
the record contains documentation that the enrollee acknowledged the
notice of hearing, and the enrollee does not contact the ALJ within 10
calendar days after the hearing for non-expedited hearings and 2
calendar days after the hearing for expedited hearings, or does contact
the ALJ but the ALJ determines the enrollee did not demonstrate good
cause for not appearing; or
(ii) The record does not contain documentation that the enrollee
acknowledged the notice of hearing, the ALJ sends a notice to the
enrollee at his or her last known address asking why the enrollee did
not appear, and the enrollee does not respond to the ALJ's notice
within 10 calendar days for non-expedited hearings or within 2 calendar
days for expedited hearings after receiving the notice, or does contact
the ALJ but the ALJ determines the enrollee did not demonstrate good
cause for not appearing. For expedited hearings, an enrollee may submit
his or her response orally to the ALJ.
(iii) In determining whether good cause exists under paragraphs
(a)(1)(i) and (ii) of this section, the ALJ considers any physical,
mental, educational, or linguistic limitations (including any lack of
facility with the English language) the enrollee may have.
(2) The person requesting a hearing has no right to it under Sec.
423.2002.
(3) The enrollee did not request a hearing within the stated time
period and the ALJ or attorney adjudicator has not found good cause for
extending the deadline, as provided in Sec. 423.2014(e).
(4) The enrollee died while the request for hearing is pending and
the request for hearing was filed by the enrollee or the enrollee's
representative, and the enrollee's surviving spouse or estate has no
remaining financial interest in the case and the enrollee's
representative, if any, does not wish to continue the appeal.
(5) The ALJ or attorney adjudicator dismisses a hearing request
entirely or refuses to consider any one or more of the issues because
an IRE, an ALJ or attorney adjudicator, or the Council has made a
previous determination or decision under this subpart about the
enrollee's rights on the same facts and on the same issue(s), and this
previous determination or decision has become binding by either
administrative or judicial action.
(6) The enrollee abandons the request for hearing. An ALJ or
attorney adjudicator may conclude that an enrollee has abandoned a
request for hearing when OMHA attempts to schedule a hearing and is
unable to contact the enrollee after making reasonable efforts to do
so.
(7) The enrollee's request is not complete in accordance with Sec.
423.2014(a)(1), even after the enrollee is provided with an opportunity
to complete the request.
(b) Dismissal of request for review of IRE dismissal. An ALJ or
attorney adjudicator dismisses a request for review of an IRE dismissal
under any of the following conditions:
(1) The enrollee has no right to a review of the IRE dismissal
under Sec. 423.2004.
(2) The enrollee did not request a review within the stated time
period and the ALJ or attorney adjudicator has not found good cause for
extending the deadline, as provided in Sec. 423.2014(e).
(3) The enrollee died while the request for review was pending and
the request was filed by the enrollee or the enrollee's representative,
and the enrollee's surviving spouse or estate has no remaining
financial interest in the case and the enrollee's representative, if
any, does not wish to continue the appeal.
(4) The enrollee's request is not complete in accordance with Sec.
423.2014(a)(1), even after the enrollee is provided with an opportunity
to complete the request.
(c) Withdrawal of request. At any time before notice of the
decision, dismissal, or remand is mailed, if the enrollee asks to
withdraw the request, an ALJ or attorney adjudicator may dismiss the
request for hearing or request for review of an IRE dismissal. This
request for withdrawal may be submitted in writing, or a request to
withdraw a request for hearing may be made orally at a hearing before
the ALJ. The request for withdrawal must include a clear statement that
the enrollee is withdrawing the request for hearing or review of the
IRE dismissal and does not intend to further proceed with the appeal.
If an attorney or other legal professional on behalf of an enrollee
files the request for withdrawal, the ALJ or attorney adjudicator may
presume that the representative has advised the enrollee of the
consequences of the withdrawal and dismissal.
(d) Notice of dismissal. OMHA mails or otherwise transmits a
written notice of the dismissal of the hearing or review request to the
enrollee at his or her last known address. The written notice provides
that there is a right to request that the ALJ or attorney adjudicator
vacate the dismissal action.
(e) Vacating a dismissal. If good and sufficient cause is
established, the ALJ or attorney adjudicator may vacate his or her
dismissal of a request for hearing or review within 6 months of the
date of the notice of dismissal.
0
128. Section 423.2054 is revised to read as follows:
Sec. 423.2054 Effect of dismissal of a request for a hearing or
request for review of an IRE's dismissal.
(a) The dismissal of a request for a hearing is binding, unless it
is vacated by the Council under Sec. 423.2108(b), or vacated by the
ALJ or attorney adjudicator under Sec. 423.2052(e).
(b) The dismissal of a request for review of an IRE dismissal of a
request for reconsideration is binding and not subject to further
review unless vacated by the ALJ or attorney adjudicator under Sec.
423.2052(e).
0
129. Section 423.2056 is added to read as follows:
Sec. 423.2056 Remands of requests for hearing and requests for
review.
(a) Missing appeal determination or case record. (1) If an ALJ or
attorney adjudicator requests an official copy of a missing
redetermination or reconsideration for an appealed coverage
determination in accordance with Sec. 423.2034, and the IRE, CMS, or
Part D plan sponsor does not furnish the copy within the time frame
specified in Sec. 423.2034, an ALJ or attorney adjudicator may issue a
remand directing the IRE or Part D plan sponsor to reconstruct the
record or, if it is not able to do so, initiate a new appeal
adjudication.
(2) If the IRE does not furnish the case file for an appealed
reconsideration, an ALJ or attorney adjudicator may issue a
[[Page 43888]]
remand directing the IRE to reconstruct the record or, if it is not
able to do so, initiate a new appeal adjudication.
(3) If the IRE or Part D plan sponsor is able to reconstruct the
record for a remanded case and returns the case to OMHA, the case is no
longer remanded and the reconsideration is no longer vacated, and any
adjudication period that applies to the appeal in accordance with Sec.
423.2016 is extended by the period between the date of the remand and
the date that case is returned to OMHA.
(b) No redetermination. If an ALJ or attorney adjudicator finds
that the IRE issued a reconsideration and no redetermination was made
with respect to the issue under appeal or the request for
redetermination was dismissed, the reconsideration will be remanded to
the IRE, or its successor, to re-adjudicate the request for
reconsideration.
(c) Requested remand--(1) Request contents and timing. At any time
prior to an ALJ or attorney adjudicator issuing a decision or
dismissal, the enrollee and CMS, the IRE, or the Part D plan sponsor
may jointly request a remand of the appeal to the IRE. The request must
include the reasons why the appeal should be remanded, and indicate
whether remanding the case will likely resolve the matter in dispute.
(2) Granting the request. An ALJ or attorney adjudicator may grant
the request and issue a remand if he or she determines that remanding
the case will likely resolve the matter in dispute.
(d) Remanding an IRE's dismissal of a request for reconsideration.
Consistent with Sec. 423.2004(b), an ALJ or attorney adjudicator will
remand a case to the appropriate IRE if the ALJ or attorney adjudicator
determines that an IRE's dismissal of a request for reconsideration was
in error.
(e) Consideration of change in condition. The ALJ or attorney
adjudicator will remand a case to the appropriate IRE if the ALJ or
attorney adjudicator determines that the enrollee wants evidence on his
or her change in condition after the coverage determination to be
considered in the appeal.
(f) Notice of a remand. OMHA mails or otherwise transmits a written
notice of the remand of the request for hearing or request for review
to the enrollee at his or her last known address, and CMS, the IRE,
and/or the Part D plan sponsor if a request to be a participant was
granted by the ALJ or attorney adjudicator. The notice states that
there is a right to request that the Chief ALJ or a designee review the
remand.
(g) Review of remand. Upon a request by the enrollee or CMS, the
IRE, or the Part D plan sponsor filed within 30 calendar days of
receiving a notice of remand, the Chief ALJ or designee will review the
remand, and if the remand is not authorized by this section, vacate the
remand order. The determination on a request to review a remand order
is binding and not subject to further review.
0
130. Section 423.2058 is added to read as follows:
Sec. 423.2058 Effect of a remand.
A remand of a request for hearing or request for review is binding
unless vacated by the Chief ALJ or a designee in accordance with Sec.
423.2056(g).
Sec. 423.2062 [Amended]
0
131. Section 423.2062 is amended by--
0
a. Amending the section heading and paragraphs (a) and (b) by removing
the term ``MAC'' each time it appears and adding ``Council'' in its
place.
0
b. Amending paragraph (a) by removing the term ``ALJs'' and adding
``ALJs and attorney adjudicators'' in its place.
0
c. Amending paragraph (b) by removing the term ``ALJ'' each time it
appears and adding ``ALJ or attorney adjudicator'' in its place.
0
132. Section 423.2063 is revised to read as follows:
Sec. 423.2063 Applicability of laws, regulations, CMS Rulings, and
precedential decisions.
(a) All laws and regulations pertaining to the Medicare program,
including, but not limited to Titles XI, XVIII, and XIX of the Social
Security Act and applicable implementing regulations, are binding on
ALJs and attorney adjudicators, and the Council.
(b) CMS Rulings are published under the authority of the CMS
Administrator. Consistent with Sec. 401.108 of this chapter, rulings
are binding on all CMS components, and on all HHS components that
adjudicate matters under the jurisdiction of CMS.
(c) Precedential decisions designated by the Chair of the
Departmental Appeals Board in accordance with Sec. 401.109 of this
chapter are binding on all CMS components, and all HHS components that
adjudicate matters under the jurisdiction of CMS.
0
133. Section 423.2100 is revised to read as follows:
Sec. 423.2100 Medicare Appeals Council review: general.
(a) Consistent with Sec. 423.1974, the enrollee may request that
the Council review an ALJ's or attorney adjudicator's decision or
dismissal.
(b) When the Council reviews an ALJ's or attorney adjudicator's
written decision, it undertakes a de novo review.
(c) The Council issues a final decision, dismissal order, or
remands a case to the ALJ or attorney adjudicator no later than the end
of the 90 calendar day period beginning on the date the request for
review is received (by the entity specified in the ALJ's or attorney
adjudicator's written notice of decision), unless the 90 calendar day
period is extended as provided in this subpart or the enrollee requests
expedited Council review.
(d) If an enrollee requests expedited Council review, the Council
issues a final decision, dismissal order or remand as expeditiously as
the enrollee's health condition requires, but no later than the end of
the 10 calendar day period beginning on the date the request for review
is received (by the entity specified in the ALJ's or attorney
adjudicator's written notice of decision), unless the 10 calendar day
period is extended as provided in this subpart.
0
134. Section 423.2102 is revised to read as follows:
Sec. 423.2102 Request for Council review when ALJ or attorney
adjudicator issues decision or dismissal.
(a)(1) An enrollee may request Council review of a decision or
dismissal issued by an ALJ or attorney adjudicator if the enrollee
files a written request for a Council review within 60 calendar days
after receipt of the ALJ's or attorney adjudicator's written decision
or dismissal.
(2) An enrollee may request that Council review be expedited if the
appeal involves an issue specified in Sec. 423.566(b) but does not
include solely a request for payment of Part D drugs already furnished.
(i) If an enrollee is requesting that the Council review be
expedited, the enrollee submits an oral or written request within 60
calendar days after the receipt of the ALJ's or attorney adjudicator's
written decision or dismissal. A prescribing physician or other
prescriber may provide oral or written support for an enrollee's
request for expedited review.
(ii) The Council must document all oral requests for expedited
review in writing and maintain the documentation in the case files.
(3) For purposes of this section, the date of receipt of the ALJ's
or attorney adjudicator's written decision or dismissal is presumed to
be 5 calendar days after the date of the notice of the decision or
dismissal, unless there is evidence to the contrary.
[[Page 43889]]
(4) The request is considered as filed on the date it is received
by the entity specified in the notice of the ALJ's or attorney
adjudicator's action.
(b) An enrollee requesting a review may ask that the time for
filing a request for Council review be extended if--
(1) The request for an extension of time is in writing or, for
expedited reviews, in writing or oral. The Council must document all
oral requests in writing and maintain the documentation in the case
file.
(2) The request explains why the request for review was not filed
within the stated time period. If the Council finds that there is good
cause for missing the deadline, the time period will be extended. To
determine whether good cause exists, the Council uses the standards
outlined at Sec. 405.942(b)(2) and (3) of this chapter.
(c) An enrollee does not have the right to seek Council review of
an ALJ's or attorney adjudicator's remand to an IRE, or an ALJ's or
attorney adjudicator's affirmation of an IRE's dismissal of a request
for reconsideration, or dismissal of a request to review an IRE
dismissal.
Sec. 423.2106 [Amended]
0
135. Section 423.2106 is amended by--
0
a. Removing the term ``ALJ'' and adding ``ALJ or attorney adjudicator''
in its place.
0
b. Removing the term ``ALJ's'' each time it appears and adding ``ALJ's
or attorney adjudicator's'' in its place.
0
c. Removing the term ``MAC'' each time it appears and adding
``Council'' in its place.
0
d. Removing the term ``MAC's'' and adding ``Council's'' in its place.
Sec. 423.2108 [Amended]
0
136. Section 423.2108 is amended by--
0
a. Amending paragraphs (a), (b), and (c) by removing the term ``ALJ''
and adding ``ALJ or attorney adjudicator'' in its place.
0
b. Amending paragraphs (a) and (d)(2)(iii) by removing the term
``ALJ's'' each time it appears and adding ``ALJ's or attorney
adjudicator's'' in its place.
0
c. Amending the section heading and paragraphs (a), (b), (c), (d)(1),
(d)(2) introductory text, (d)(3) introductory text, and (d)(3)(ii) by
removing the term ``MAC'' each time it appears and adding ``Council''
in its place.
0
d. Amending paragraph (a) by removing the term ``MAC's'' and adding
``Council's'' in its place.
0
e. Amending the paragraph heading and text of paragraph (b) by removing
the phrase ``ALJ's dismissal'' and adding ``ALJ's or attorney
adjudicator's dismissal of a request for a hearing'' in its place.
0
137. Section 423.2110 is revised to read as follows:
Sec. 423.2110 Council reviews on its own motion.
(a) General rule. The Council may decide on its own motion to
review a decision or dismissal issued by an ALJ or attorney
adjudicator. CMS or the IRE may refer a case to the Council for it to
consider reviewing under this authority any time within 60 calendar
days after the date of an ALJ's or attorney adjudicator's written
decision or dismissal.
(b) Referral of cases. (1) CMS or the IRE may refer a case to the
Council if, in the view of CMS or the IRE, the decision or dismissal
contains an error of law material to the outcome of the appeal or
presents a broad policy or procedural issue that may affect the public
interest. CMS or the IRE may also request that the Council take own
motion review of a case if--
(i) CMS or the IRE participated or requested to participate in the
appeal at the OMHA level; and
(ii) In CMS' or the IRE's view, the ALJ's or attorney adjudicator's
decision or dismissal is not supported by the preponderance of evidence
in the record or the ALJ or attorney adjudicator abused his or her
discretion.
(2) CMS' or the IRE's referral to the Council is made in writing
and must be filed with the Council no later than 60 calendar days after
the ALJ's or attorney adjudicator's written decision or dismissal is
issued.
(i) The written referral will state the reasons why CMS or the IRE
believes that the Council should review the case on its own motion.
(ii) CMS or the IRE will send a copy of its referral to the
enrollee and to the OMHA Chief ALJ.
(iii) The enrollee may file exceptions to the referral by
submitting written comments to the Council within 20 calendar days of
the referral notice.
(iv) An enrollee submitting comments to the Council must send the
comments to CMS or the IRE.
(c) Standard of review--(1) Referral by CMS or the IRE when CMS or
the IRE participated or requested to participate in the OMHA level. If
CMS or the IRE participated or requested to participate in an appeal at
the OMHA level, the Council exercises its own motion authority if there
is an error of law material to the outcome of the case, an abuse of
discretion by the ALJ or attorney adjudicator, the decision is not
consistent with the preponderance of the evidence of record, or there
is a broad policy or procedural issue that may affect the general
public interest. In deciding whether to accept review under this
standard, the Council will limit its consideration of the ALJ's or
attorney adjudicator's action to those exceptions raised by CMS or the
IRE.
(2) Referral by CMS or the IRE when CMS or the IRE did not
participate or request to participate in the OMHA proceedings. The
Council will accept review if the decision or dismissal contains an
error of law material to the outcome of the case or presents a broad
policy or procedural issue that may affect the general public interest.
In deciding whether to accept review, the Council will limit its
consideration of the ALJ's or attorney adjudicator's action to those
exceptions raised by CMS or the IRE.
(d) Council's action. (1) If the Council decides to review a
decision or dismissal on its own motion, it will mail the results of
its action to the enrollee and to CMS or the IRE, as appropriate.
(2) The Council may adopt, modify, or reverse the decision or
dismissal, may remand the case to an ALJ or attorney adjudicator for
further proceedings, or may dismiss a hearing request.
(3) The Council must issue its action no later than 90 calendar
days after receipt of the CMS or the IRE referral, unless the 90
calendar day period has been extended as provided in this subpart.
(4) The Council may not issue its action before the 20 calendar day
comment period has expired, unless it determines that the agency's
referral does not provide a basis for reviewing the case.
(5) If the Council declines to review a decision or dismissal on
its own motion, the ALJ's or attorney adjudicator's decision or
dismissal is binding.
Sec. 423.2112 [Amended]
0
138. Section 423.2112 is amended by--
0
a. Amending paragraphs (a)(1), (b), and (c) by removing the term
``ALJ's'' and adding ``ALJ's or attorney adjudicator's'' in its place.
0
b. Amending paragraph (b) by removing the term ``ALJ'' and adding ``ALJ
or attorney adjudicator'' in its place.
0
c. Amending paragraphs (a)(1) and (3), and (c) by removing the term
``MAC'' and adding ``Council'' in its place.
Sec. 423.2114 [Amended]
0
139. Section 423.2114 is amended in the introductory text and paragraph
(b) by removing the term ``MAC'' each time it appears and adding
``Council'' in its place.
[[Page 43890]]
Sec. 423.2116 [Amended]
0
140. Section 423.2116 is amended by--
0
a. Removing the term ``MAC'' each time it appears and adding
``Council'' in its place.
0
b. Removing the term ``MAC's'' and adding ``Council's'' in its place.
0
c. Removing the term ``ALJ'' and adding ``ALJ or attorney adjudicator''
in its place.
Sec. 423.2118 [Amended]
0
141. Section 423.2118 is amended by--
0
a. Removing the term ``MAC'' each time it appears and adding
``Council'' in its place.
0
b. Removing the term ``MAC's'' and adding ``Council's'' in its place.
0
c. Removing the phrase ``ALJ hearing'' and adding ``ALJ's or attorney
adjudicator's action'' in its place.
0
d. Removing the phrase ``the exhibits list'' and adding ``any index of
the administrative record'' in its place.
0
e. Removing the term ``CD'' and adding ``audio recording'' in its
place.
Sec. 423.2120 [Amended]
0
142. Section 423.2120 is amended by removing the term ``MAC'' each time
it appears and adding ``Council'' in its place.
Sec. 423.2122 [Amended]
0
143. Section 423.2122 is amended by--
0
a. Amending the section heading and paragraphs (a) paragraph heading,
(a)(1), (2), and (3), (b) introductory text, (b)(1) and (2), and
(c)(1), (2), (3), and (4) by removing the term ``MAC'' each time it
appears and adding ``Council'' in its place.
0
b. Amending paragraphs (a) paragraph heading and (a)(1) by removing the
term ``ALJ's'' and adding ``ALJ's or attorney adjudicator's'' in its
place.
0
c. Amending paragraph (a)(1) by removing the term ``ALJ level'' and
adding ``OMHA level'' in its place.
0
d. Amending paragraph (a)(1) by removing the term ``hearing decision''
and adding ``ALJ's or attorney adjudicator's decision'' in its place.
0
e. Amending paragraphs (a)(1) and (2) by removing the term ``ALJ'' and
adding ``ALJ or attorney adjudicator'' in its place.
0
f. Amending paragraph (a)(2) by removing the term ``hearing record''
and adding ``administrative record'' in its place.
0
g. Amending paragraph (c)(3) by removing the term ``MAC's'' and adding
``Council's'' in its place.
Sec. 423.2124 [Amended]
0
144. Section 423.2124 is amended in the introductory text and
paragraphs (a), (b), (c), (d), and (e) by removing the term ``MAC''
each time it appears and adding ``Council'' in its place.
Sec. 423.2126 [Amended]
0
145. Section 423.2126 is amended by--
0
a. Amending the section heading and paragraphs (a) paragraph heading,
(a)(1), (2), and (3), (a)(4) paragraph heading, (a)(4)(i) and (ii),
(a)(5) paragraph heading, (a)(5)(i) and (ii), and (b) by removing the
term ``MAC'' each time it appears and adding ``Council'' in its place.
0
b. Amending paragraphs (a) paragraph heading, (a)(1), (2), and (3),
(a)(4) paragraph heading, and (a)(5)(ii) by removing the term ``ALJ''
each time it appears and adding ``ALJ or attorney adjudicator'' in its
place.
0
c. Amending paragraph (a)(2) by removing the term ``MAC's and adding
``Council's'' in its place.
0
d. Amending paragraph (a)(5)(ii) by adding ``if applicable'' after the
word ``rehearing''.
Sec. 423.2128 [Amended]
0
146. Section 423.2128 is amended by--
0
a. Amending the section heading and paragraphs (a), (b), and (c) by
removing the term ``MAC'' each time it appears and adding ``Council''
in its place.
0
b. Amending paragraph (a) by removing the term ``ALJ'' and adding ``ALJ
or attorney adjudicator'' in its place.
0
c. Amending paragraph (b) by removing the phrase ``ALJ hearing
decision'' and adding ``ALJ or attorney adjudicator decision'' in its
place.
Sec. 423.2130 [Amended]
0
147. Section 423.2130 is amended in the section heading and text by
removing the term ``MAC's'' each time it appears and adding
``Council's'' in its place.
Sec. 423.2134 [Amended]
0
148. Section 423.2134 is amended in paragraphs (b)(3) and (c) by
removing the term ``MAC'' and adding ``Council'' in its place.
Sec. 423.2136 [Amended]
0
149. Section 423.2136 is amended by--
0
a. Amending paragraphs (a) and (c)(3) by removing the term ``MAC'' and
adding ``Council'' in its place.
0
b. Amending paragraph (c)(2) by removing the term ``MAC's'' and adding
``Council's'' in its place.
0
c. Amending paragraph (c)(3) by removing the term ``ALJ'' and adding
``ALJ or attorney adjudicator'' in its place.
Sec. 423.2138 [Amended]
0
150. Section 423.2138 is amended by--
0
a. Removing the term ``MAC'' each time it appears and adding
``Council'' in its place.
0
b. Removing the term ``ALJ'' and adding ``ALJ or attorney adjudicator''
in its place.
Sec. 423.2140 [Amended]
0
151. Section 423.2140 is amended by--
0
a. Amending the section heading and paragraphs (a)(1), (2), and (3),
(b)(1), (b)(2) introductory text, (b)(2)(ii), (b)(3) and (4), (c)
paragraph heading, (c)(1), (3), and (4), and (d) by removing the term
``MAC'' each time it appears and adding ``Council'' in its place.
0
b. Amending the section heading and paragraphs (a)(1), (2), and (3),
(b) paragraph heading, (b)(1), (b)(2) introductory text, (b)(2)(i),
(b)(3) and (4), (c)(1) and (4), and (d) by removing the term ``ALJ''
each time it appears and adding ``ALJ or attorney adjudicator'' in its
place.
0
c. Amending paragraph (d) by removing the term ``ALJ's'' and adding
``ALJ's or attorney adjudicator's'' in its place.
PART 478--RECONSIDERATIONS AND APPEALS
0
152. The authority citation for part 478 continues to read as follows:
Authority: Secs. 1102 and 1871 of the Social Security Act (42
U.S.C. 1302 and 1395hh).
0
153. Section 478.14(c)(2) is amended by removing the phrase ``part 405,
subpart G of this chapter for determinations under Medicare Part A, and
part 405, subpart H of this chapter for determinations under Medicare
Part B'' and adding ``part 405, subpart I of this chapter for
determinations under Medicare Part A and Part B'' in its place.
0
154. Section 478.40 is amended by revising paragraphs (a) and (c) to
read as follows:
Sec. 478.40 Beneficiary's right to a hearing.
(a) Amount in controversy. If the amount in controversy is at least
$200, a beneficiary (but not a provider or practitioner) who is
dissatisfied with a QIO reconsidered determination may request a
hearing by an administrative law judge (ALJ) of the Office of Medicare
Hearings and Appeals (OMHA).
* * * * *
(c) Governing provisions. The provisions of subpart I of part 405
of this chapter apply to hearings and appeals under this subpart unless
they
[[Page 43891]]
are inconsistent with specific provisions in this subpart or implement
statutory provisions that are not also applicable under section 1155 of
the Social Security Act. References in subpart I to initial
determinations made by a Medicare contractor and reconsiderations made
by a QIC should be read to mean initial determinations and reconsidered
determinations made by a QIO.
0
155. Section 478.42 is revised to read as follows:
Sec. 478.42 Submitting a request for a hearing.
(a) Where to submit the written request. A beneficiary who wants to
obtain a hearing under Sec. 478.40 must submit a written request to
the OMHA office identified in the notice of the QIO reconsidered
determination.
(b) Time limit for submitting a request for a hearing. (1) The
request for a hearing must be filed within 60 calendar days of receipt
of the notice of the QIO reconsidered determination, unless the time is
extended for good cause as provided in Sec. 478.22.
(2) The date of receipt of the notice of the reconsidered
determination is presumed to be 5 calendar days after the date on the
notice, unless there is evidence to the contrary.
(3) A request is considered filed on the date it is received by
OMHA.
0
156. Section 478.44 is revised to read as follows:
Sec. 478.44 Determining the amount in controversy for a hearing.
(a) After an individual appellant has submitted a request for a
hearing, the ALJ or attorney adjudicator determines the amount in
controversy in accordance with Sec. 405.1006(d) and (e) of this
chapter. When two or more appellants submit a request for hearing, the
ALJ or attorney adjudicator determines the amount in controversy in
accordance with Sec. 405.1006(d) and (e) of this chapter.
(b) If the ALJ or attorney adjudicator determines that the amount
in controversy is less than $200, the ALJ, without holding a hearing,
or attorney adjudicator notifies the parties that the parties have 15
calendar days to submit additional evidence to prove that the amount in
controversy is at least $200.
(c) At the end of the 15-day period, if an ALJ determines that the
amount in controversy is less than $200, the ALJ, without holding a
hearing dismisses the request for a hearing without ruling on the
substantive issues involved in the appeal and notifies the parties and
the QIO that the QIO reconsidered determination is conclusive for
Medicare payment purposes.
0
157. Section 478.46 is revised to read as follows:
Sec. 478.46 Medicare Appeals Council and judicial review.
(a) The circumstances under which the Medicare Appeals Council
(Council) will review an ALJ's or attorney adjudicator's decision or
dismissal are the same as those set forth at Sec. Sec. 405.1102
(``Request for Council review when ALJ or attorney adjudicator issues
decision or dismissal'') and 405.1110 (``Council reviews on its own
motion'') of this chapter.
(b) If $2,000 or more is in controversy, a party may obtain
judicial review of a Council decision, or an ALJ's or attorney
adjudicator's decision if a request for review by the Council was
denied, by filing a civil action under the Federal Rules of Civil
Procedure within 60 days after the date the party received notice of
the Council decision or denial.
0
158. Section 478.48 is amended by revising the section heading and
paragraphs (b) and (c) to read as follows:
Sec. 478.48 Reopening and revision of a reconsidered determination or
a decision.
* * * * *
(b) ALJ or attorney adjudicator and Council Reopening--Applicable
procedures. The ALJ or attorney adjudicator, or the Council, whichever
made the decision, may reopen and revise the decision in accordance
with the procedures set forth in Sec. 405.980 of this chapter, which
concerns reopenings and revised decisions under subpart I of part 405
of this chapter.
(c) Fraud or similar abusive practice. A reconsidered
determination, a review of a DRG change, or a decision of an ALJ or
attorney adjudicator, or the Council may be reopened and revised at any
time, if the reconsidered determination, review, or decision was
obtained through fraud or a similar abusive practice that does not
support a formal finding of fraud.
Approved: June 8, 2016.
Sylvia Burwell,
Secretary, Department of Health and Human Services.
[FR Doc. 2016-15192 Filed 6-28-16; 4:15 pm]
BILLING CODE 4150-46-P
