Medicare Program: Changes to the Medicare Claims and Medicare Prescription Drug Coverage Determination Appeals Procedures, 49513-49529 [2018-21223]

Agencies

• Centers for Medicare & Medicaid Services
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 83, Number 191 (Tuesday, October 2, 2018)]
[Proposed Rules]
[Pages 49513-49529]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-21223]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 405 and 423

[CMS-4174-P]
RIN 0938-AT27


Medicare Program: Changes to the Medicare Claims and Medicare 
Prescription Drug Coverage Determination Appeals Procedures

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Proposed rule.

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SUMMARY: This proposed rule would revise the regulations setting forth 
the appeals process that Medicare beneficiaries, providers, and 
suppliers must follow in order to appeal adverse determinations 
regarding claims for benefits under Medicare Part A and Part B or 
determinations for prescription drug coverage under Part D. These 
changes would help streamline the appeals process and reduce 
administrative burden on providers, suppliers, beneficiaries, and 
appeal adjudicators. These revisions, which include technical 
corrections, would also help to ensure the regulations are clearly 
arranged and written to give stakeholders a better understanding of the 
appeals process.

DATES: To be assured consideration, comments must be received at one of 
the addresses provided below, no later than 5 p.m. on December 3, 2018.

ADDRESSES: In commenting, please refer to file code CMS-4174-P. Because 
of staff and resource limitations, we cannot accept comments by 
facsimile (FAX) transmission.
    Comments, including mass comment submissions, must be submitted in 
one of the following three ways (please choose only one of the ways 
listed):
    1. Electronically. You may submit electronic comments on this 
regulation to https://www.regulations.gov. Follow the ``Submit a 
comment'' instructions.
    2. By regular mail. You may mail written comments to the following 
address only: Centers for Medicare & Medicaid Services, Department of 
Health and Human Services, Attention: CMS-4174-P, P.O. Box 8013, 
Baltimore, MD 21244-1850.
    Please allow sufficient time for mailed comments to be received 
before the close of the comment period.
    3. By express or overnight mail. You may send written comments to 
the following address only: Centers for Medicare & Medicaid Services, 
Department of Health and Human Services, Attention: CMS-4174-P, Mail 
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
    For information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: Joella Roland, (410) 786-7638 or 
Nishamarie Sherry, (410) 786-1189.

SUPPLEMENTARY INFORMATION: Inspection of Public Comments: All comments

[[Page 49514]]

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 
post all comments received before the close of the comment period on 
the following website as soon as possible after they have been 
received: https://www.regulations.gov. Follow the search instructions on 
that website to view public comments.

I. Background

    As specified under sections 1869 and 1860D-4 of the Social Security 
Act (the Act) and their implementing regulations, once Medicare makes a 
coverage or payment determination under Medicare Parts A, B, or D, 
affected parties have the right to appeal the decision through four 
levels of administrative review. If a minimum amount in controversy 
(AIC) is met, parties can then appeal the decision to federal district 
court.
    Section 1869 of the Act sets forth the process for appealing Parts 
A and B claim determinations. For most Part A and B claims, the initial 
determination is made by a Medicare Administrative Contractor (MAC). If 
a party is dissatisfied with the initial determination, the party may 
request a redetermination by the MAC, which is a review by MAC staff 
not involved in the initial determination. If a party is dissatisfied 
with the MAC's redetermination, the party may request a Qualified 
Independent Contractor (QIC) reconsideration consisting of an 
independent review of the administrative record, including the 
redetermination. Provided a minimum AIC is met, parties then have the 
option to appeal to the Office of Medicare Hearings and Appeals (OMHA) 
where they may receive either a hearing or review of the administrative 
record by an Administrative Law Judge (ALJ), or a review of the 
administrative record by an attorney adjudicator. Parties then have the 
option to appeal to the Medicare Appeals Council (the Council) within 
the Departmental Appeals Board, where an Administrative Appeals Judge 
examines their claim. A party can then appeal the decision to federal 
district court if certain requirements are met, including a minimum 
AIC.
    The appeals process described above for Parts A and B claim 
determinations was initially proposed in the November 15, 2002 Federal 
Register (67 FR 69312), which was promulgated to implement section 521 
of the Medicare, Medicaid, and SCHIP Benefits Improvement and 
Protection Act of 2000 (Pub. L. 106-554). This process was implemented 
in an interim final rule with comment period published on March 8, 2005 
(the 2005 interim final rule with comment period) (70 FR 11420), which 
also set forth new provisions to implement the Medicare Prescription 
Drug, Improvement, and Modernization Act of 2003 (Pub. L. 108-173). 
Correcting amendments to the 2005 interim final rule were published on 
June 30, 2005 (70 FR 37700) and August 26, 2005 (70 FR 50214), and the 
final rule was published on December 9, 2009 (74 FR 65296). Subsequent 
revisions to implement section 201 of the Strengthening Medicare and 
Repaying Taxpayers Act of 2012 (Pub. L. 112-242) were published on 
February 27, 2015 (80 FR 10611). These appeals procedures for Part A 
and B claims are set forth in regulations at part 405, subpart I.
    Section 1860D-4 of the Act sets forth the appeals process for Part 
D coverage determinations. Under Medicare Part D, the Part D plan 
sponsor issues a coverage determination. If this coverage determination 
is appealed, the Part D plan sponsor reviews the determination, which 
is known as a redetermination. If a party is dissatisfied with the 
redetermination, the party may request a reconsideration by an 
independent review entity. Similar to the appeals process for Parts A 
and B claim determinations, provided a minimum AIC is met, parties then 
have the option to appeal to OMHA where they may receive either a 
hearing or review of the administrative record by an ALJ, or a review 
of the administrative record by an attorney adjudicator. If not 
satisfied with OMHA's decision, a party then may appeal to the Council. 
The Council decision then may be appealed to federal district court if 
certain requirements are met, including a minimum AIC. These procedures 
are set forth in regulations at part 423, subparts M and U.
    On January 17, 2017, we issued a final rule entitled ``Medicare 
Program: Changes to the Medicare Claims and Entitlement, Medicare 
Advantage Organization Determination, and Medicare Prescription Drug 
Coverage Determination Appeals Procedures'' (82 FR 4974) (the January 
17, 2017 final rule), which revised the Parts A, B, C, and D appeals 
procedures. The goals of this rulemaking were to streamline the appeals 
process, increase consistency in decision-making, improve efficiency 
for both appellants and adjudicators, and provide particular benefit to 
beneficiaries by clarifying processes and adding provisions for 
increased assistance when they are unrepresented. On April 16, 2018, we 
issued a final rule (83 FR 16440) that made additional changes to 
subparts M and U in order to implement section 704 of the Comprehensive 
Addiction and Recovery Act of 2016 (Pub. L. 114-198), along with other 
changes.
    Through our experience implementing the current appeals process, 
and through additional research, we have identified several 
opportunities to streamline the claims appeals process and reduce 
associated burden on providers, beneficiaries, and appeals 
adjudicators. We have also identified several technical corrections 
that should be made to correct cross-references, inconsistent 
definitions, and confusing terminology.

II. Provisions of the Proposed Regulations

A. Removal of Requirement That Appellants Sign Appeal Requests 
(Sec. Sec.  405.944, 405.964, 405.1112, and 423.2112)

    Existing regulations at part 405, subpart I; and part 423, subparts 
M and U, specify the required elements of requests for Medicare Parts A 
and B claims appeals and for Medicare Part D coverage determination 
appeals, respectively. Generally, when a contractor or plan issues a 
Part A or B initial determination or a Part D coverage determination, 
it notifies the provider, supplier, and/or beneficiary and offers the 
opportunity to appeal. If this determination is appealed, the 
contractor or plan reviews the determination, which, in Medicare Parts 
A, B and D appeals, is known as a redetermination (see Sec. Sec.  
405.940 and 423.580). This can be followed by a review by an 
independent contractor consisting of an independent review of the 
administrative record, including the redetermination, which is known as 
a reconsideration (Sec. Sec.  405.960 and 423.600). If a minimum 
amount-in-controversy is met, parties then have the option to appeal to 
the OMHA where the administrative record may be reviewed by an attorney 
adjudicator or an ALJ or a hearing may be held by an ALJ (Sec. Sec.  
405.1000 et seq. and 423.2000 et seq.). Parties then have the option to 
appeal to the Council within the Departmental Appeals Board where an 
Administrative Appeals Judge reviews their claim (Sec. Sec.  405.1100 
et seq. and 423.2100 et seq.).
    Appeal requests can be made using different standard forms. These 
standard forms include the following: Medicare Redetermination Request 
Form (CMS-20027); Medicare Reconsideration Request Form (CMS-20033); 
Request for

[[Page 49515]]

Administrative Law Judge Hearing or Review of Dismissal (OMHA-100); and 
Request for Review of Administrative Law Judge (ALJ) Medicare Decision/
Dismissal (DAB-101). A written request that is not made on a standard 
form is also accepted if it contains certain required elements. For 
example, see, Sec. Sec.  405.944(b), 405.964(b), 405.1014(a), 405.1112, 
423.2014(a), 423.2112.
    As discussed previously, all Medicare Parts A, B, and D appeal 
requests must contain the information specified in our regulations. In 
addition, for Parts A and B claims appeal requests at the 
redetermination, reconsideration, and Council review levels (Sec. Sec.  
405.944(b)(4), 405.964(b)(4), and 405.1112(a)), and for Part D coverage 
determination appeal requests at the Council level (Sec.  
423.2112(a)(4)), the appellants must sign their appeal requests. 
However, there is no signature requirement when the appellant requests 
OMHA review of Parts A and B claim determinations, or when the 
appellant requests a redetermination, reconsideration, or OMHA review 
of Part D coverage determinations. In addition, there is no requirement 
that appellants sign appeals requests for appeals of Part C 
organization determinations.
    In order to promote consistency between appeal levels, ensure 
transparency in developing our appeal request requirements, help ensure 
that we do not impose nonessential requirements on appellants, reduce 
the burden on appellants, and improve the appeals process based on our 
experience, we are proposing that appellants in Medicare Parts A and B 
claim and Part D coverage determination appeals be allowed to submit 
appeal requests without a signature. Specifically, we are proposing to 
revise Sec. Sec.  405.944(b)(4), 405.964(b)(4), 405.1112(a), and 
423.2112(a)(4) to remove the requirement of the appellant's signature 
for appeal requests.
    As discussed previously, there is no requirement that appellants 
sign appeal requests when appealing their cases to OMHA, for the Part C 
organization determination appeals process, or at the redetermination 
and reconsideration levels of Part D appeals. However, the other 
requirements for appeal requests are substantially similar between 
levels of appeal and appeals processes, or there is a clear reason for 
the differing requirements. For example, the requirements for Part A 
and B appeal requests at the redetermination and reconsideration levels 
are identical with the exception of the reconsideration requirement 
that the name of the contractor be listed on the reconsideration appeal 
request (Sec. Sec.  405.944 and 405.964). The rationale for the 
requirement that the name of the contractor be included on 
reconsideration appeal requests is that without this information, the 
independent contractor does not have a method of determining which 
contractor made the initial determination and redetermination, and is 
unable to get the case file. Since the contractor doing the 
redetermination is the same contractor who performed the initial 
determination, it is not necessary that this information be included in 
the redetermination appeal request.
    By contrast, we do not believe there is a compelling reason to 
require that a signature be included on redetermination, 
reconsideration, and Council-level appeal requests, but not on OMHA 
appeal requests. Removing the requirement that appellants sign their 
appeal requests, would help promote consistency between appeal request 
requirements, thus making the appeals process easier for parties to 
understand.
    Eliminating the requirement that appellants sign their appeal 
requests would reduce the burden of developing the appeal request and 
appealing dismissals of appeal requests for lack of a signature to the 
next level of review (for example, Sec. Sec.  405.952(b), 405.972(b)). 
Allowing adjudicators to review appeal requests without signatures 
would allow them to focus their attention on the merits of the appeal, 
rather than having to dismiss potentially meritorious appeals for a 
lack of a signature.
    When we promulgated the requirement for appellants to sign the 
appeal requests in regulations, we included a signature on the appeal 
request to ensure that the person requesting the appeal was a proper 
party to the appeal. Through experience, we have found that, in 
practice, little verification of the signature is possible. To 
determine if the appeal requestor is a proper party to the appeal, the 
adjudicator uses the name of the beneficiary and name of the party 
listed on the appeal request, in addition to the information listed in 
the case file.
    The other appeal request requirements consist of fields that are 
necessary for the adjudicators to properly process the appeal request. 
As discussed previously, the name of the contractor who made the 
redetermination is required for the independent contractor to review 
the case file. The Part A and B redetermination appeal request 
requirement to include the disputed service and/or item enables the 
contractor to determine the merit of the appellant's claim.
    Thus, we believe there is no need for a signature on an appeal 
request at this time and propose to eliminate that requirement. 
However, if, we find in the future that there are other reasons that 
would warrant an appellant's signature on an appeal request (for 
example, for a good-faith attestation), we would re-examine the 
possibility of adding the requirement back in. However, given that our 
existing statutory authority limits our ability to enforce certain 
attestations, we find the signature requirement unnecessary.
    We are inviting public comments on our proposal to revise 
Sec. Sec.  405.944(b)(4), 405.964(b)(4), 405.1112(a), and 
423.2112(a)(4) of the regulations to remove the requirement that the 
appellant sign the appeal request.

B. Change to Timeframe for Vacating Dismissals (Sec. Sec.  405.952, 
405.972, 405.1052, and 423.2052)

    The regulations at Sec. Sec.  405.952(d), 405.972(d), 405.1012(e), 
and 423.2052(e) allow adjudicators to vacate a dismissal of an appeal 
request for a Medicare Part A or B claim or Medicare Part D coverage 
determination within 6 months of the date of the notice of dismissal. 
This allows sufficient time for adjudicators to carefully evaluate 
their dismissals while taking into account the principle of 
administrative finality.
    Through experience, we have concluded that the timeframe for 
vacating a dismissal would be better expressed in calendar days, rather 
than months, for two reasons. First, all timeframes in the regulations 
under part 405, subpart I and part 423 subpart U, associated with the 
filing of appeal requests, adjudication periods, reopening of prior 
determinations, and other time-limited procedural actions are expressed 
in calendar days, not months. For example, see Sec. Sec.  405.942 and 
423.2056. Second, applying a timeframe based on days, rather than 
months, leads to more consistency in interpretation and actual 
timeframes. A timeframe based on months could be subject to varying 
interpretations, as the number of days in a consecutive 6-month period 
varies from 181 to 184 days. For example, if an ALJ or attorney 
adjudicator's dismissal is dated August 31 of one calendar year, 
advancing the timeframe 6 months to February could be confusing for 
parties and adjudicators because February does not contain 30 or 31 
days. Also, given that February has only 28 or 29 days (in a leap 
year), any 6-month period that includes February would be shorter than 
other 6 month periods, leading to

[[Page 49516]]

some inconsistency in the actual timeframe for vacating a dismissal.
    To provide more consistency and predictability for appellants and 
adjudicators, and better conformity with other timeframes in the part 
405, subpart I and part 423 subpart U, we are proposing to revise the 
timeframe for vacating a dismissal from 6 months to 180 days in 
Sec. Sec.  405.952(d), 405.972(d), 405.1052(e), and 423.2052(e).

C. Technical Correction to Regulations To Change Health Insurance Claim 
Number (HICN) References to Medicare Numbers (Sec. Sec.  405.910, 
405.944, 405.964, 405.1014, 405.1112, 423.2014, and 423.2112)

    Section 501 of the Medicare Access and CHIP Reauthorization Act of 
2015 (MACRA) (Pub. L. 114-10), added section 205(c)(2)(C)(xiii) of the 
Act to prohibit Social Security Numbers (or derivatives) from being 
displayed on Medicare cards. As a result, CMS is undertaking efforts to 
issue new Medicare cards, which contain a randomly generated Medicare 
Beneficiary Identifier (MBI), rather than the Social Security Number-
based Health Insurance Claim Number (HICN) that is on the current 
Medicare cards. In order to ensure that appellants can easily submit 
appointment of representative documentation and appeal requests, we 
would accept this documentation with HICNs or MBIs. Consistent with 
these efforts, we are proposing to remove references to the Social 
Security Number-based HICN on Medicare cards that are included in the 
Medicare appeals regulations, and to replace them with references to 
Medicare number to clarify that either a HICN or MBI can be included on 
appointment of representative documentation and appeal requests. 
Accordingly, we are proposing to revise the following provisions of 
Medicare regulations to remove the words ``health insurance claim'' 
from the phrase ``Medicare health insurance claim number'' so that 
there is only a reference to ``Medicare number'': Sec. Sec.  
405.910(c)(5), 405.944(b)(2), 405.964(b)(2), 405.1014(a)(1)(i), 
405.1112(a), 423.2014(a)(1)(i), and 423.2112(a)(4).

D. Removal of Redundant Regulatory Provisions Relating to Medicare 
Appeals of Payment and Coverage Determinations and Conforming Changes 
(Sec. Sec.  423.562, 423.576, 423.602, 423.604, 423.1970, 423.1972, 
423.1974, 423.1976, 423.1984, 423.1990, 423.2002, 423.2004, 423.2006, 
423.2014, 423.2020, 423.2044, 423.2100, and 423.2136)

    The January 17, 2017 final rule revised certain Medicare procedures 
for appeals of payment and coverage determinations for items and 
services furnished to Medicare beneficiaries and enrollees. Since the 
publication of this final rule, we have identified four regulatory 
provisions in part 423, subpart U that are redundant. In order to 
reduce potential confusion, we are proposing to remove redundant 
provisions at Sec. Sec.  423.1970, 423.1972, 423.1974, and 423.1976 
and, where necessary, incorporate appropriate provisions in other 
sections of the regulations.
    Section 423.1970 of the regulations relating to the rights of 
enrollees to an ALJ hearing provides--
     In paragraph (a), that, if the amount remaining in 
controversy after the independent review entity (IRE) reconsideration 
meets the threshold requirement established annually by the Secretary, 
an enrollee who is dissatisfied with the IRE reconsideration 
determination has a right to a hearing before an ALJ;
     In paragraph (b)(1), the methodology for computing the AIC 
when the basis for appeal is the refusal by the Part D plan sponsor to 
provide drug benefits;
     In paragraph (b)(2), the methodology for computing the AIC 
when the basis for appeal is an at-risk determination made under a drug 
management program in accordance with Sec.  423.153(f); and
     In paragraph (c), the requirements for aggregating appeals 
to meet the AIC.
    Section 423.2002 also contains provisions on the right to an ALJ 
hearing. This section contains cross-references to the provisions in 
Sec.  423.1970, and also--
     Establishes a 60-calendar day timeframe for filing a 
written request for an ALJ hearing following receipt of the written 
notice of the IRE's reconsideration; and indicates the AIC requirement 
must be met to be entitled to an ALJ hearing;
     Provides the circumstances under which an enrollee may 
request that an ALJ hearing be expedited;
     Establishes a 5-calendar day presumption for receipt of 
the reconsideration following the date of the written reconsideration, 
unless there is evidence to the contrary; and
     Provides that, for purposes of the section, requests for 
hearing are considered as filed on the date they are received by the 
office specified in the IRE's reconsideration.
    Because Sec. Sec.  423.1970 and 423.2002 both address the right to 
an ALJ hearing, and because there is a possibility that confusion may 
arise from having two sections with the same title in the same CFR 
subpart, we are proposing to remove Sec.  423.1970. Because Sec.  
423.1970(a) is redundant of Sec. Sec.  423.2000(a) and 423.2002(a)(2) 
in describing that an enrollee has a right to an ALJ hearing when the 
enrollee is dissatisfied with an IRE reconsideration and meets the AIC 
requirement, we believe Sec.  423.1970(a) should be eliminated. We are 
proposing to relocate Sec.  423.1970(b) and (c) to new proposed Sec.  
423.2006 (``Amount in controversy required for an ALJ hearing and 
judicial review'') as paragraphs (c) and (d), respectively.
    In addition, we are proposing to remove the reference to ``CMS'' in 
Sec.  423.1970(b) (relocated to proposed Sec.  423.2006(c)) to clarify 
that adjudicators, not CMS, ultimately compute the amount remaining in 
controversy in determining whether the AIC threshold is met for an ALJ 
hearing or review of an IRE dismissal, and judicial review.
    We believe having one section titled ``Right to an ALJ hearing'' at 
Sec.  423.2002 and another section titled ``Amount in controversy 
required for an ALJ hearing and judicial review'' at Sec.  423.2006 is 
more consistent with the corresponding rules in 42 CFR part 405, 
subpart I for appeals of Medicare Part A and Part B initial 
determinations (Sec. Sec.  405.1002 and 405.1006). For consistency with 
Sec.  423.2000(a) and language that was removed from Sec.  423.1970(a), 
we are also proposing to add language to Sec.  423.2002(a) providing 
that the right to an ALJ hearing is available to enrollees who are 
dissatisfied with the IRE's reconsideration determination.
    In order to further increase consistency with Sec.  405.1006 and 
consolidate the Medicare Part D appeals rules regarding the AIC, we are 
proposing to incorporate provisions in proposed new Sec.  423.2006(a) 
and (b) that are similar to those provisions contained at Sec.  
405.1006(b) and (c), describing the amounts in controversy required for 
an ALJ hearing and judicial review, respectively, including the annual 
adjustment of these amounts. In order to more clearly state the AIC 
requirements for appeals of Part D prescription drug plan coverage

[[Page 49517]]

determinations, without the need for multiple statutory and regulatory 
cross-references, we are proposing that new Sec.  423.2006 would 
include the following:
     At proposed paragraph (a)(1), a provision similar to Sec.  
405.1006(b)(1) that the required amount remaining in controversy must 
be $100 increased by the percentage increase in the medical care 
component of the Consumer Price Index for All Urban Consumers (U.S. 
city average) as measured from July 2003 to the July preceding the 
current year involved.
     At proposed paragraph (a)(2), a provision similar to Sec.  
405.1006(b)(2) that, if the figure in Sec.  423.2006(a)(1) is not a 
multiple of $10, it is rounded to the nearest multiple of $10, and that 
the Secretary will publish changes to the AIC requirement in the 
Federal Register when necessary.
     At proposed paragraph (b), a provision similar to Sec.  
405.1006(c) that, to be entitled to judicial review, the enrollee must 
meet the AIC requirements of this subpart and have an amount remaining 
in controversy of $1000 or more, adjusted as specified in proposed 
Sec.  423.2006(a)(1) and (2).
     At proposed paragraph (c), a provision similar to current 
Sec.  423.1970(b) explaining how the amount remaining in controversy is 
calculated.
     At proposed paragraph (d), the text currently found in 
Sec.  423.1970(c) concerning aggregation of appeals to meet the amount 
in controversy.
    Finally, we are proposing to update or remove the cross-references 
to Sec.  423.1970 in Sec. Sec.  423.562(b)(4)(iv), 423.576, 
423.602(b)(2), 423.1984(c); 423.2002(a) introductory text and (a)(2), 
and (b)(3), 423.2004(a)(2), and 423.2044(c) and to add a cross-
reference to Sec.  423.2006 in Sec.  423.1990(b)(3) in place of the 
language ``established annually by the Secretary.''
    Section 423.1972, titled ``Request for an ALJ hearing,'' provides 
the procedures an enrollee must follow when filing a request for 
hearing as follows:
     Paragraph (a) provides that a written request must be 
filed with the OMHA office specified in the IRE's reconsideration 
notice.
     Paragraph (b) provides the timeframe for filing a request.
     Paragraph (c)(1) states that if a request for hearing 
clearly shows that the AIC is less than that required under Sec.  
423.1970, the ALJ or attorney adjudicator dismisses the request.
     Paragraph (c)(2) provides that if, after a hearing is 
initiated, the ALJ finds that the AIC is less than the amount required 
under Sec.  423.1970, the ALJ discontinues the hearing and does not 
rule on the substantive issues raised in the appeal.
    With the exception of paragraph (c)(2), all of the provisions in 
Sec.  423.1972 are duplicative of or incorporate by reference other 
provisions found in Sec.  423.2002(a) and (d) (Right to an ALJ 
hearing), Sec.  423.2014(d)(2) and (e) (Request for an ALJ hearing or a 
review of an IRE dismissal), Sec.  423.2020 (Time and place for a 
hearing before an ALJ), and Sec.  423.2052(a)(2) (Dismissal of a 
request for a hearing before an ALJ or request for review of an IRE 
dismissal). In order to eliminate the redundancy and potential 
confusion, we are proposing to remove Sec.  423.1972 in its entirety. 
As a part of this proposed change, we also are proposing to update or 
remove the cross-references to Sec.  423.1972 in Sec. Sec.  423.604, 
423.1984(c), 423.2014(d) introductory text and (e)(1), and 423.2020(a). 
We do not believe it is necessary to retain Sec.  423.1972(c)(2) in 
another location because ALJs have broad authority to regulate the 
course of the hearing. In the rare circumstances described in Sec.  
423.1972(c)(2) where an ALJ does not make a finding regarding the AIC 
until after a hearing is initiated, the ALJ may discontinue the hearing 
and issue a dismissal under Sec. Sec.  423.2002(a)(2) and 
423.2052(a)(2).
    Section 423.1974, titled ``Council review,'' provides that 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. This provision is similar to Sec.  423.2100, titled 
``Medicare Appeals Council review: general.'' To eliminate the 
redundancy, we are proposing to remove the language of Sec.  423.1974 
and incorporate it in Sec.  423.2100(a). This language would replace 
the language in Sec.  423.2100(a). We also are proposing to update or 
remove the cross-references to Sec.  423.1974 in Sec. Sec.  
423.562(b)(4)(v) and 423.1984(d).
    Section 423.1976, titled ``Judicial review,'' provides the 
following:
     In paragraph (a), that an enrollee may request judicial 
review of an ALJ's or attorney adjudicator's decision if the Council 
denied the enrollee's request for review and the AIC meets the 
threshold requirement established annually by the Secretary.
     In paragraph (b), that the enrollee may request judicial 
review of a Council decision if it is the final decision of CMS and the 
AIC meets the threshold established in paragraph (a)(2).
     In paragraph (c), that, in order to request judicial 
review, an enrollee must file a civil action in a district court of the 
United States in accordance with section 205(g) of the Act.
    With the exception of paragraph (a), these provisions are largely 
duplicative of other provisions contained in Sec.  423.2136, also 
titled ``Judicial review.'' To eliminate this redundancy, we are 
proposing to remove the provisions of Sec.  423.1976 and revise Sec.  
423.2136 as follows:
     Section 423.2136(a) would be redesignated as Sec.  
423.2136(a)(1). The cross-reference to Sec.  423.1976 would be removed, 
and language from Sec.  423.1976(b) would be incorporated in Sec.  
423.2136(a)(1)(i) and (ii) and revised by replacing ``CMS'' with ``the 
Secretary'' for consistency with the language in section 1876(c)(5)(B) 
of the Act and Sec.  423.2140, and replacing ``paragraph (a)(2) of this 
section'' with ``Sec.  423.2006'' which we are proposing to add to the 
regulations to address the AIC requirements.
     Language at Sec.  423.1976(a) would be revised to 
incorporate a reference to Sec.  423.2006 and the authorizing language 
from Sec.  423.2136(a) (proposed Sec.  423.2136(a)(1)) and moved to new 
Sec.  423.2136(a)(2).
     We also are proposing to update or remove the cross-
references to Sec.  423.1976 in Sec. Sec.  423.562(b)(4)(vi), 423.576, 
and 423.2136(b)(1). We seek comment on these proposed changes.
    In summary, we are proposing to remove or relocate language as 
shown in the following table:

----------------------------------------------------------------------------------------------------------------
          Current section                Proposed new section         Proposed action            Rationale
----------------------------------------------------------------------------------------------------------------
Sec.   423.1970(a).................  N/A........................  Remove................  Similar language
                                                                                           exists in Sec.  Sec.
                                                                                            423.2000(a) and
                                                                                           423.2002(a)(2).
Sec.   423.1970(b).................  Sec.   423.2006............  Remove and incorporate  Increases consistency
                                                                   revised language at     with Sec.   405.1006.
                                                                   proposed new Sec.
                                                                   423.2006(c).
Sec.   423.1970(c).................  ...........................  Remove and incorporate
                                                                   at proposed new Sec.
                                                                    423.2006(d).

[[Page 49518]]

 
N/A................................  Sec.   423.2006(a).........  Add language
N/A................................  Sec.   423.2006(b).........   concerning AIC
                                                                   computation not
                                                                   previously outlined
                                                                   in 42 CFR part 423.
Sec.   423.1972(a), Sec.             N/A........................  Remove................  Similar language
 423.1972(b), Sec.   423.1972(c)(1).                                                       exists in Sec.  Sec.
                                                                                            423.2002(a) and (d),
                                                                                           423.2014(d)(2) and
                                                                                           (e), 423.2020, and
                                                                                           423.2052(a)(2) and
                                                                                           reduces redundancy.
Sec.   423.1972(c)(2)..............  N/A........................  Remove................  Unnecessary.
Sec.   423.1974....................  N/A........................  Remove and incorporate  Reduces redundancy.
                                                                   into Sec.
                                                                   423.2100(a).
Sec.   423.1976(a).................  N/A........................  Remove and incorporate
                                                                   revised language at
                                                                   new Sec.
                                                                   423.2136(a)(2).
Sec.   423.1976(b).................  ...........................  Remove and incorporate
                                                                   revised language at
                                                                   proposed new Sec.
                                                                   423.2136(a)(1).
Sec.   423.1976(c).................  N/A........................  Remove................  Similar language
                                                                                           exists in Sec.
                                                                                           423.2136(b)(1).
----------------------------------------------------------------------------------------------------------------

E. Change to Timeframe for Council Referral (Sec.  405.1110 and Sec.  
423.2110)

    The regulations at Sec. Sec.  405.1110(a) and (b)(2) and 
423.2110(a) and (b)(2) give CMS or its contractors 60 calendar days 
after the date or issue date, respectively, of OMHA's decision or 
dismissal to refer the case to the Council. In the case of Part A and 
Part B appeals, CMS or its contractors are sent the decision notice 
when they are a party to the hearing or soon after the hearing 
occurred. For Part D appeals, as specified in Sec.  423.2046(a)(1), the 
decision notice is sent to the enrollee, plan sponsor, and IRE.
    Our regulations generally include regulatory timeframes that start 
when CMS or its contractors receive the decision notice, rather than 
the date the decision notice was issued. For example, Sec.  
405.1010(b)(3), which addresses the timing of when CMS or its 
contractor may elect to participate in an ALJ hearing, provides that 
CMS or its contractor must send notice of its intent to participate, if 
no hearing is scheduled, no later than 30 calendar days after 
notification that a request for hearing was filed or, if a hearing is 
scheduled, no later than 10 calendar days after receiving the notice of 
hearing. The rationale for starting the timeframe in Sec.  
405.1010(b)(3) after receipt of the notice was to ensure that CMS or 
its contractors have sufficient time to conduct a thorough evaluation 
of the facts and the case.
    For the same reason, we are proposing to revise the timeframe in 
Sec. Sec.  405.1110(a) and (b)(2) and 423.2110(a) and (b)(2) for CMS or 
it contractors to refer a case to the Council such that the timeframe 
would begin after the ALJ's or attorney adjudicator's decision or 
dismissal is received. Starting the timeframe after CMS or its 
contractor receives OMHA's written decision or dismissal would help 
ensure that CMS and its contractors have sufficient time to decide 
whether the case is the type of case that should be referred to the 
Council for review. This proposed change would help ensure that even if 
CMS and its contractors receive a delayed notice, they would have 
sufficient time to decide whether the case should be referred to the 
Council.
    In order to ensure consistent implementation of this proposal, we 
also are proposing to add new Sec. Sec.  405.1110(e) and 423.2110(e) to 
provide that 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. This would help facilitate the Council's determination on 
the timeliness of the referral by establishing a date by which the 
Council may presume that CMS or its contractor received the decision 
from OMHA. This 5 day mailing presumption is consistent with the 
presumption included in Sec. Sec.  405.1102(a)(2) and 423.2102(a)(3) 
with respect to the timeframe for requesting Council review following 
an ALJ's or attorney adjudicator's decision or dismissal.
    For these reasons, we are proposing to revise the Council referral 
timeframes in Sec. Sec.  405.1110(a) and (b)(2) and 423.2110(a) and 
(b)(2), and proposing to add Sec. Sec.  405.1110(e) and 423.2110(e) as 
discussed previously.

F. Technical Correction to Regulation Regarding Duration of Appointed 
Representative in a Medicare Secondary Payer Recovery Claim (Sec.  
405.910)

    Section 405.910 sets forth provisions addressing the appointment of 
representatives in a Medicare Parts A and B claims appeals, including 
for secondary payer recovery claims. Specific requirements regarding 
the duration of time that an appointment of representative instrument 
is valid are provided under Sec.  405.910(e).
    On February 27, 2015, we published a final rule entitled ``Medicare 
Program; Right of Appeal for Medicare Secondary Payer Determinations 
Relating to Liability Insurance (Including Self-Insurance), No-Fault 
Insurance, and Workers' Compensation Laws and Plans (80 FR 10611). In 
that final rule, we added paragraph (e)(4) to Sec.  405.910 in order to 
provide applicable plans with the benefit of the existing rule for 
Medicare secondary payers regarding the duration of appointment for an 
appointed representative. Within this added provision, we included a 
citation to Sec.  405.906(a)(1)(iv), as the regulation establishing 
party status for applicable plans. This citation is an incorrect cross-
reference; and the correct cross-reference is Sec.  405.906(a)(4). We 
are proposing to revise Sec.  405.910(e)(4) to correct the cross-
reference. This proposed correction would not alter any existing 
processes or procedures within the Medicare claims appeals process.

G. Technical Correction to Actions That Are Not Initial Determinations 
(Sec.  405.926)

    Section 405.926 sets forth actions that are not considered initial 
determinations subject to the administrative appeals process under part 
405, subpart I. On October 4, 2016, we issued a final rule entitled 
``Medicare and Medicaid Programs; Reform of Requirements for Long-Term 
Care Facilities'' (81 FR 68688 through 68872) that moved the definition 
of ``transfer and discharge'' in Sec.  483.12 to the definitions under 
Sec.  483.5.

[[Page 49519]]

Accordingly, we updated the cross-reference to ``Sec.  483.5'' within 
Sec.  405.926(f) to the cross-reference to ``Sec.  483.5(n)''. However, 
the citation of Sec.  483.5(n) is an incorrect cross-reference.
    To correct this error, we are proposing to revise Sec.  405.926(f) 
to remove the incorrect reference to ``Sec.  483.5(n)'' and replace it 
with the cross-reference ``Sec.  483.5 definition of `transfer and 
discharge' ''. This proposed technical correction would serve to 
correct an incorrect citation. It would not alter any existing 
processes or procedures within the Medicare claims appeals process.

H. Changes To Enhance Implementation of Rule Streamlining the Medicare 
Appeals Procedures (Sec. Sec.  405.970, 405.1006, 405.1010, 405.1014, 
405.1020, 405.1034, 405.1046, 405.1052, 405.1056, 423.1014, 423.1990, 
423.2002, 423.2010, 423.2016, 423.2032, 423.2034, 423.2036, 423.2052, 
and 423.2056)

    Since we published the January 17, 2017 final rule, we have 
identified several provisions that, upon further review, pose 
unanticipated challenges with implementation, which are explained in 
this section. In addition, there are other regulatory provisions that 
we believe require additional clarification and the correction of 
technical errors and omissions. In the proposals listed in this 
section, we seek to help ensure the provisions are implemented as 
intended, provide clarification, and correct technical errors and 
omissions. Our proposed changes are as follows.
1. Amount in Controversy (AIC) (Sec.  405.1006)
    Section 405.1006 addresses the AIC required for an ALJ hearing and 
judicial review, and Sec.  405.1006(d) provides the methodology for 
computing the AIC. In general, the AIC is computed as the amount that 
the provider or supplier bills for the items and services in the 
disputed claim, reduced by any Medicare payments already made or 
awarded for the items or services, and further reduced by any 
deductible and/or coinsurance amounts that may be collected for the 
items or services. In the January 17, 2017 final rule, we created 
several exceptions to this general computation methodology for 
situations where we believed an alternative methodology would more 
accurately describe the amount actually in dispute. Among these 
alternatives was the calculation methodology specified in Sec.  
405.1006(d)(4), which states that when an appeal involves an identified 
overpayment, the AIC is the amount of the overpayment specified in the 
demand letter for the items or services in the disputed claim. For 
appeals involving an estimated overpayment amount determined through 
the use of statistical sampling and extrapolation, Sec.  405.1006(d)(4) 
further provides that the AIC is the total amount of the estimated 
overpayment determined through extrapolation, as specified in the 
demand letter.
    When we created this exception, we did not account for the 
possibility that the amount of the overpayment or estimated overpayment 
specified in the demand letter might change throughout the 
administrative appeals process if, for example, an adjudicator finds 
that some of the items or services for which an overpayment was 
demanded are covered and payable, or alternatively, if an adjudicator 
raises a new issue that results in the denial of additional items or 
services. Even outside the administrative appeals process, the amount 
of an overpayment may be revised by a CMS contractor (for example, 
following a discussion period with the contractor that initially 
determined the overpayment). Although some of these situations may 
result in the issuance of a revised demand letter, such a letter may 
not always be issued during the pendency of the appeals process.
    To account for situations where the amount of an overpayment 
specified in the demand letter does not reflect subsequent adjustments 
to the amount remaining in controversy, we are proposing to revise 
Sec.  405.1006(d)(4) to state that when an appeal involves an 
identified overpayment, the AIC is the amount of the overpayment 
specified in the demand letter, or the amount of the revised 
overpayment if the amount originally demanded changes as a result of a 
subsequent determination or appeal, for the items or services in the 
disputed claim. For appeals involving an estimated overpayment amount 
determined through the use of statistical sampling and extrapolation, 
we are further proposing to revise Sec.  405.1006(d)(4) to state that 
the AIC is the total amount of the estimated overpayment determined 
through extrapolation, as specified in the demand letter, or as 
subsequently revised.
2. Submissions by CMS and CMS Contractors (Sec. Sec.  405.1010 and 
405.1012)
    In Sec.  405.1010(b)(1), we stated that if CMS or a CMS contractor 
elects to participate in the proceedings on a request for hearing 
before receipt of a notice of hearing, or when notice of hearing is not 
required, it 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, or if the appeal is not 
assigned, to a designee of the Chief ALJ. We discussed in the January 
17, 2017 final rule that the requirement to notify the parties who were 
sent a copy of the notice of reconsideration helps ensure that the 
potential parties to a hearing, if a hearing is conducted, would 
receive notice of the intent to participate (82 FR 5016). However, the 
final regulation at Sec.  405.1010(b)(1) does not account for requests 
for reconsideration that are escalated from the QIC level to the OMHA 
level of appeal without a notice of reconsideration having been issued.
    In order to help ensure that the potential parties to a hearing 
would receive notice of CMS' or the contractor's intent to participate 
and address reconsideration escalations from the QIC to OMHA, we are 
proposing to revise Sec.  405.1010(b)(1) to require that, for escalated 
requests for reconsideration, notice of the intent to participate would 
also be sent to any party that filed a request for reconsideration or 
was found liable for the services at issue subsequent to the initial 
determination, which we believe is consistent with circumstances under 
which a party would receive notice of a hearing under Sec.  405.1020. 
(Section 405.1020(c)(1) also provides that a notice of hearing is sent 
to all parties that participated in the reconsideration. However, we do 
not believe this provision is necessary in circumstances where the QIC 
has not issued a reconsideration because, in practice, there is 
generally no opportunity for participation in these circumstances by 
parties other than the party that filed the request for 
reconsideration.) For the same reason, we also are proposing to revise 
Sec.  405.1010(c)(3)(ii)(A), which currently requires that copies of 
CMS or contractor position papers or written testimony that are 
submitted before receipt of a notice of hearing must be sent to the 
parties who were sent a copy of the notice of reconsideration. We are 
proposing to revise Sec.  405.1010(c)(3)(ii)(A) to instead provide that 
copies are sent to the parties that are required to be sent a copy of 
the notice of intent to participate in accordance with Sec.  
405.1010(b)(1). No corresponding revisions to Sec.  423.2010 are needed 
because escalation is not available in Medicare Part D appeals.
    In Sec.  405.1010(b)(3)(ii), we stated that if CMS or a CMS 
contractor elects to participate after a hearing is scheduled, it must 
send written notice of its intent to participate no later than 10 
calendar days ``after receiving the notice of

[[Page 49520]]

hearing.'' Upon reviewing the revised rules, we noticed an 
inconsistency between this language and the language in Sec.  
405.1012(a)(1), which requires CMS or a CMS contractor electing to be a 
party to a hearing to send written notice of its intent to be a party 
no later than 10 calendar days ``after the QIC receives the notice of 
hearing.'' We explained in the January 17, 2017 final rule (82 FR 5020) 
that the timeframe in Sec.  405.1012(a)(1) was based on receipt of the 
notice of hearing by the QIC because notices of hearing are currently 
sent to the QIC in accordance with Sec.  405.1020(c). We believe these 
requirements should be consistent and the timeframes should begin on 
the same date, regardless of whether CMS or a CMS contractor is 
electing to be a party or participant. We also believe that the 
regulations should provide flexibility for CMS to designate another 
contractor, other than the QIC, to receive notices of hearing under 
Sec.  405.1020(c) if that contractor is then tasked with disseminating 
the notice of hearing to other CMS contractors. Therefore, and as 
discussed in this section with regard to notices of hearing, we are 
proposing to revise Sec.  405.1020(c)(1) to provide for this 
flexibility.
    For conformity with proposed revised Sec.  405.1020(c)(1) and to 
resolve the existing inconsistency in Sec. Sec.  405.1010(b)(3)(ii) and 
405.1012(a)(1), we are proposing to revise both sections to provide 
that written notice of the intent to participate or intent to be a 
party must be submitted no later than 10 calendar days after receipt of 
the notice of hearing by the QIC or another contractor designated by 
CMS to receive the notice of hearing. No corresponding revision is 
needed to the part 423, subpart U rules because notices of hearing are 
sent to both the Medicare Part D plan sponsor and the IRE.
    In Sec.  405.1010(c)(3)(i), we state that CMS or a CMS contractor 
that filed an election to participate must submit any position papers 
or written testimony within 14 calendar days of its 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. In the January 17, 2017 final rule (82 FR 5017), we 
discussed that the requirement to submit any written testimony within 
14 calendar days of the election to participate if no hearing has been 
scheduled helps to ensure that 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.
    Although Sec.  405.1010(c)(3)(i) allows an ALJ to extend the 5-
calendar day submission timeframe for cases in which a hearing is 
scheduled, the regulation text may be unclear as to whether the same 
discretion is afforded to ALJs or attorney adjudicators with respect to 
the 14-calendar day submission timeframe for cases in which no hearing 
has been scheduled. Our intent was to apply this discretionary 
extension in both circumstances, as evidenced by the corresponding 
regulation at Sec.  423.2010(d)(3)(i), which allows an ALJ or attorney 
adjudicator to grant additional time to submit a position paper or 
written testimony both in cases where a hearing has been scheduled and 
in cases where no hearing has been scheduled (82 FR 5019). Accordingly, 
to clarify our intent and help ensure consistency between the part 405 
and part 423, we are proposing to revise Sec.  405.1010(c)(3)(i) to 
clarify that an ALJ or attorney adjudicator may also extend the 14-
calendar day timeframe for submission of position papers and written 
testimony in cases in which no hearing has been scheduled.
    In Sec.  405.1012(b), we stated that if CMS or a CMS contractor 
elects to be a party to the hearing, it must send written notice of its 
intent to the ALJ and to ``the parties identified in the notice of 
hearing.'' Upon reviewing the revised rules, we noticed an 
inconsistency between this language and the language in Sec.  
405.1010(b)(2), which states that if CMS or a CMS contractor elects to 
participate after receipt of a notice of hearing, it must to send 
written notice of its intent to participate to the ALJ and ``the 
parties who were sent a copy of the notice of hearing.'' Although the 
standard for who must receive notice is the same, the way in which it 
is articulated is different, which we believe may lead to confusion. To 
prevent potential confusion and help ensure consistency in the 
regulations, we are proposing to revise Sec.  405.1012(b)(2) by 
replacing the language ``identified in the notice of hearing'' with 
``who were sent a copy of the notice of hearing''. No corresponding 
revision is needed to the part 423, subpart U rules because only the 
enrollee is a party to a Medicare Part D appeal and CMS, the IRE, and 
the Part D plan sponsor may only request to be nonparty participants.
    Finally, Sec.  405.1012(e)(1) states the circumstances under which 
an ALJ or attorney adjudicator may determine that a CMS or contractor 
election to be a party to a hearing made under Sec.  405.1012 is 
invalid. Because Sec.  405.1012(a) only permits CMS or a contractor to 
elect to be a party after the QIC receives a notice of hearing, and 
only an ALJ may schedule and conduct a hearing, we believe the 
determination as to whether an election made under Sec.  405.1012 is 
valid should be left to the assigned ALJ. Therefore, we are proposing 
in Sec.  405.1012(e)(1) to replace the phrase ``ALJ or attorney 
adjudicator'' with ``ALJ.'' No corresponding revision is needed to the 
part 423, subpart U rules because only the enrollee is a party to a 
Medicare Part D appeal and CMS, the IRE, and the Part D plan sponsor 
may only request to be nonparty participants.
3. Extension Requests (Sec. Sec.  405.1014 and 423.2014)
    Prior to the January 17, 2017 final rule, Sec.  405.1014(c)(2) 
provided that any request for an extension of the time to request a 
hearing must be in writing, give the reasons why the request for a 
hearing was not filed within the stated time period, and must be filed 
with the entity specified in the notice of reconsideration. In the 
January 17, 2017 final rule, this provision was relocated to Sec.  
405.1014(e)(2) and revised, in part, to state that any request for an 
extension of the time to request a hearing or review of a QIC dismissal 
must be filed with the request for hearing or request for review. This 
change was motivated by questions from appellants concerning whether a 
request for an extension should be filed without a request for hearing 
so that a determination could be made on the extension request before 
the request for hearing was filed (82 FR 5038). However, in our attempt 
to provide clarity to appellants, we created a requirement that, in its 
strictest interpretation, would foreclose an appellant from requesting 
an extension of the time to request a hearing or review after a request 
for hearing is filed. The need for such a request to be made may arise 
when an appellant--particularly an unrepresented beneficiary--is not 
aware that a request for hearing is untimely at the time of filing. In 
these situations, OMHA frequently requests that the appellant provide 
an explanation for the untimely filing and, if the OMHA adjudicator 
finds good cause for the untimely filing, the time period for filing is 
extended in accordance with Sec.  405.1014(e)(3).
    In order to remedy this situation, we are proposing to revise Sec.  
405.1014(e)(2) to provide that requests for extension must be filed 
with the request for hearing or request for review, or upon notice that 
the request may be dismissed because it was not timely filed. We also

[[Page 49521]]

are proposing a corresponding revision to Sec.  423.2014(e)(3) for 
extension requests filed by Medicare Part D enrollees.
4. Notice of Hearing (Sec.  405.1020)
    In Sec.  405.1020(c)(1), we require that a notice of hearing be 
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 elected to participate in 
the proceedings in accordance with Sec.  405.1010(b) or that the ALJ 
believes would be beneficial to the hearing, advising them of the 
proposed time and place of the hearing. However, this rule does not 
account for requests for reconsideration that are escalated from the 
QIC level to the OMHA level of appeal without a reconsideration having 
been issued.
    To help ensure that the QIC, and other CMS contractors who receive 
notice of scheduled hearings through the QIC, receive notice of all 
scheduled hearings, we are proposing to revise Sec.  405.1020(c)(1) to 
require that notice be sent to the QIC that issued the reconsideration 
or from which the request for reconsideration was escalated. As 
discussed in section II.H.3. of this proposed rule with regard to CMS 
and CMS contractor submissions, we also are proposing to provide future 
flexibility for CMS to designate another contractor to receive notices 
of hearing by revising Sec.  405.1020(c)(1) to state, in part, that the 
notice of hearing may instead be sent to another contractor designated 
by CMS to receive it. No corresponding revisions are needed in Sec.  
423.2020(c)(1) because escalation is not available in Medicare Part D 
appeals, and notices of hearing are sent to both the Medicare Part D 
plan sponsor and the IRE.
5. Request for an In-Person or Video Teleconference (VTC) Hearing 
(Sec. Sec.  405.1020 and 423.2020)
    Section 405.1020(i)(1) and (i)(5) provides that if an unrepresented 
beneficiary who filed the request for hearing objects to a video-
teleconference (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, an 
ALJ may grant the unrepresented beneficiary's or other party's request 
for an in-person or VTC hearing if it satisfies the requirements in 
Sec.  405.1020(i)(1) through (3), with the concurrence of the Chief ALJ 
or a designee and upon a finding of good cause. Prior to the January 
17, 2017 final rule, Sec.  405.1020(i) dealt exclusively with a party's 
request for an in-person hearing and Sec.  405.1020(i)(5) required 
concurrence of the Managing Field Office ALJ and a finding of good 
cause for an ALJ to grant the request. (As we discussed in the January 
17, 2017 final rule, the position of Managing Field Office ALJ was 
replaced by the position of Associate Chief ALJ, and we replaced the 
reference to ``Managing Field Office ALJ'' in Sec.  405.1020(i)(5) with 
``Chief ALJ or a designee'' to provide greater flexibility in the 
future as position titles change.) Managing Field Office ALJ 
concurrence and a finding of good cause were not required prior to the 
January 17, 2017 final rule for requests for a VTC hearing because VTC 
was the default method of hearing.
    When we revised Sec.  405.1020(i) in the January 17, 2017 final 
rule to reflect the change from VTC to telephone hearing as the default 
method for appearances by parties other than unrepresented 
beneficiaries, we neglected to restrict the requirement for the 
concurrence of the Chief ALJ or designee to requests for in-person 
hearing, in accordance with Sec.  405.1020(b)(1)(ii) and (b)(2)(ii). In 
addition, we neglected to clarify that, because VTC is the default 
hearing method for unrepresented beneficiaries, a finding of good cause 
is not required when an unrepresented beneficiary who filed the request 
for hearing objects to an ALJ's offer to conduct a hearing by telephone 
and requests a VTC hearing. Accordingly, we are proposing to revise 
Sec.  405.1020(i)(5) to clarify that concurrence of the Chief ALJ or 
designee is only required if the request is for an in-person hearing, 
and that a finding of good cause is not required for a request for VTC 
hearing made by an unrepresented beneficiary who filed the request for 
hearing and objects to an ALJ's offer to conduct a hearing by 
telephone. We also are proposing corresponding revisions to Sec.  
423.2020(i)(5) for objections filed by Medicare Part D enrollees.
    In reviewing the January 17, 2017 final rule, we also noted 
potential confusion about whether Sec.  405.1020(e) or (i) applies to 
objections to the place of a hearing when the objection is accompanied 
by a request for a VTC or an in-person hearing. While an objection to a 
hearing being conducted by telephone or VTC may broadly qualify as an 
objection to the place of the hearing under Sec.  405.1020(e), our 
intent was for Sec.  405.1020(i) to apply to such an objection when the 
objection is accompanied by a request for a different hearing format, 
because Sec.  405.1020(i) is specific to an objection to the scheduled 
hearing format and request for an alternate hearing format. To mitigate 
the potential confusion as to which provisions applies, we are 
proposing to revise Sec.  405.1020(e) by adding paragraph (e)(5) to 
make clear that it applies only when the party's or enrollee's 
objection does not include a request for an in-person or VTC hearing. 
We also are proposing a corresponding revision to Sec.  423.2020(e) 
concerning a Medicare Part D enrollee's objection to the time and place 
of hearing.36. Dismissal of a Request for a Hearing (Sec. Sec.  
405.1052 and 423.2052)
    Section 405.1052(a) describes the situations under which an ALJ may 
dismiss a request for hearing (other than withdrawals of requests for 
hearing, which are described in Sec.  405.1052(c)). Although paragraph 
(a) pertains only to ALJ dismissals, paragraphs (a)(3), (4)(i), (5), 
and (6) contain inadvertent references to attorney adjudicators.
     Paragraph (a)(3) states that an ALJ may dismiss a request 
for hearing when 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).
     Paragraph (a)(4)(i) provides that when determining whether 
the beneficiary's surviving spouse or estate has a remaining financial 
interest, the ALJ or attorney adjudicator considers whether 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. (As discussed 
in section II.H.10. of this proposed rule, we are proposing to change 
the reference to ``limitation of liability'' to ``limitation on 
liability.'')
     Paragraph (a)(5) states that an 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 part 405, Subpart I 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.
     Paragraph (a)(6) states that 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.

[[Page 49522]]

    As discussed of in the January 17, 2017 final rule (82 FR 4982), 
our intent in finalizing the attorney adjudicator proposals was to 
provide authority for attorney adjudicators to dismiss a request for 
hearing only when an appellant withdraws his or her request for an ALJ 
hearing, and not under any other circumstances. We further explained 
that attorney adjudicators could not dismiss a request for hearing due 
to procedural issues or make a determination that would result in a 
dismissal of a request for an ALJ hearing (other than a determination 
that the appellant had withdrawn the request for hearing) (82 FR 5008 
and 5009). Therefore, we are proposing to revise Sec.  405.1052(a)(3), 
(a)(4)(i), and (a)(6) to remove the reference to attorney adjudicators 
and paragraph (a)(5) to remove the first reference to an attorney 
adjudicator. We also are proposing corresponding corrections to Sec.  
423.2052(a)(3), (5), and (6) for dismissals of Part D requests for 
hearing.
    Prior to the January 17, 2017 final rule, Sec.  405.1052(b) 
required that notice of a dismissal of a request for hearing be sent to 
all parties at their last known address. We explained in the final rule 
that the requirement to send notice of the dismissal to all parties was 
overly inclusive and caused 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 (82 
FR 5086). Therefore, we revised this provision (and moved it to Sec.  
405.1052(d)) to state that OMHA mails or otherwise transmits a written 
notice of a dismissal of a request for hearing or review to all parties 
who were sent a copy of the request for hearing or review at their last 
known address.
    However, in our effort to better tailor the list of recipients, we 
neglected to specify that notice is also sent to the appellant--who 
must receive notice of the dismissal, but would not have received a 
copy of its own request for hearing or review--and to account for CMS 
or a CMS contractor who elected to be a party to the appeal. We believe 
that CMS or a CMS contractor that is a party to an appeal has an 
interest in the outcome of the appeal and should be notified if the 
request for hearing or review is dismissed. Section 405.1046 helps 
ensure that CMS or CMS contractors who are a party to a hearing receive 
notice of the decision by requiring that the decision be sent to all 
parties at their last known address. In order to help ensure CMS and 
CMS contractors are afforded similar notice of dismissals, and that the 
appellant is notified of a dismissal of its request for hearing or 
review, we are proposing to revise Sec.  405.1052(d) to require that 
notice be sent to the appellant, all parties who were sent a copy of 
the request for hearing or review at their last known address, and to 
CMS or a CMS contractor that is a party to the proceedings on a request 
for hearing. No corresponding revision to Sec.  423.2052 is needed 
because only the enrollee is a party to a Medicare Part D appeal and 
receives notice of the dismissal.
7. Remanding a Dismissal of a Request for Reconsideration (Sec. Sec.  
405.1056, 405.1034, 423.2034, and 423.2056)
    Section 405.1056(a)(1) provides that 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 timeframe 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. Section 405.1056(a)(2) provides that 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. In Sec.  405.1056(d), 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.
    Occasionally, an ALJ or attorney adjudicator may need to remand a 
request for review of a dismissal of a reconsideration request for 
reasons similar to those specified in Sec.  405.1056(a)(1) and (2) 
because the ALJ or attorney adjudicator is unable to obtain an official 
copy of the dismissal determination, or because the QIC does not 
furnish the case file for an appealed dismissal. By restricting the 
bases for remand under Sec.  405.1056(a)(1) and (2) to appeals of 
reconsiderations, we inadvertently made these reasons unavailable for 
remands of requests for review of a dismissal under Sec.  405.1056(d). 
Therefore, we are proposing to revise Sec.  405.1056(d) by 
redesignating existing paragraph (d) as paragraph (d)(1), and adding 
paragraph (d)(2) to state that an ALJ or attorney adjudicator may also 
remand a request for review of a dismissal in accordance with the 
procedures in paragraph (a) of the section if an official copy of the 
notice of dismissal or case file cannot be obtained from the QIC. We 
also are proposing corresponding revisions to Sec.  423.2056(d) for 
Medicare Part D remands of a request for review of an IRE's dismissal 
of a request for reconsideration. This proposed change would 
necessitate two additional revisions.
    First, Sec. Sec.  405.1056(g) and 423.2056(g), which discuss 
reviews of remands by the Chief ALJ or designee, state that the review 
of remand procedures are not available for and do not apply to remands 
that are issued under Sec. Sec.  405.1056(d) or 423.2056(d), 
respectively. In the January 17, 2017 final rule, we explained that 
this limitation was due to the fact that remands issued on review of a 
QIC's or IRE's dismissal of a request for reconsideration (that is, 
based on a determination that the QIC's or IRE's dismissal was in 
error) are more akin to a determination than a purely procedural 
mechanism (82 FR 5069 through 5070). Because remands issued under new 
proposed Sec. Sec.  405.1056(d)(2) and 423.2056(d)(2) would be 
procedural remands, we are proposing to revise Sec. Sec.  405.1056(g) 
and 423.2056(g) by replacing the references to paragraph (d) with a 
reference to paragraph (d)(1), so that remands issued under paragraph 
(d)(2) would be subject to the review of remand procedures in paragraph 
(g).
    Second, we are proposing to revise Sec. Sec.  405.1034(a)(1) and 
423.2034(a)(1) to provide that the request for information procedures 
in these paragraphs apply not only to requests for official copies of 
redeterminations and reconsiderations, but also to requests for 
official copies of dismissals of requests for redetermination or 
reconsideration.
8. Notice of a Remand (Sec.  405.1056)
    Section 405.1056(f) provides that OMHA mails or otherwise transmits 
written notice of a remand of a request for hearing or request for 
review to all of the parties who were sent a copy of the request for 
hearing or review, at their last known address, and to CMS or a 
contractor that elected to be a participant in the proceedings or party 
to the hearing. However, Sec.  405.1056(f) does not require that notice 
be sent to the appellant, who would not have received a copy of its own 
request for hearing or review. For the same reasons described in 
section II.H.6 above with regard to notices of dismissal, we are 
proposing to revise Sec.  405.1056(f) to require that notice be sent to 
the appellant, all parties who were sent a copy of the request for 
hearing or review at their last known address, and to CMS or a 
contractor that elected to be a participant in the proceedings or party

[[Page 49523]]

to the hearing. No corresponding revision to part 423, subpart U is 
needed because Sec.  423.2056(f) already provides that notice is sent 
to the enrollee, who is the only party to a Part D appeal.
    In addition, Sec.  405.1056(f) provides that the notice of remand 
states that there is a right to request that the Chief ALJ or a 
designee review the remand. However, Sec.  405.1056(g) states that the 
review of remand procedures are not available for and do not apply to 
remands that are issued under Sec.  405.1056(d) (which, as noted in 
section II.H.D.7. of this proposed rule, we are proposing to 
redesignate as Sec.  405.1056(d)(1)). To resolve this discrepancy and 
help ensure that parties receive accurate information regarding the 
availability of the review of remand procedures, we are proposing to 
revise Sec.  405.1056(f) to clarify that the notice of remand states 
that there is a right to request that the Chief ALJ or a designee 
review the remand, unless the remand was issued under Sec.  
405.1056(d)(1). We are also proposing corresponding changes to Sec.  
423.2056(d)(1).
9. Requested Remands (Sec.  423.2056)
    Section 423.2056(b) provides that 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 readjudicate the request for 
reconsideration. However, when we finalized this provision in the 
January 17, 2017 final rule, we did not account for situations in which 
no redetermination was issued because the Medicare Part D plan sponsor 
failed to meet the timeframe for a standard or expedited 
redetermination, as provided in Sec.  423.590. In these situations, 
Sec.  423.2056(b) does not provide a basis for remand because the 
failure of the Part D plan sponsor to provide a redetermination within 
the specified timeframe constitutes an adverse redetermination 
decision, and the Part D plan sponsor is required to forward the 
enrollee's request to the IRE within 24 hours of the expiration of the 
adjudication timeframe in accordance with Sec.  423.590(c) (for 
requests for standard redeterminations) and (e) (for requests for 
expedited redeterminations). Accordingly, we are proposing to revise 
Sec.  423.2056(b) to clarify that this reason for remand does not apply 
when the request for redetermination was forwarded to the IRE in 
accordance with Sec.  423.590(c) or (e) without a redetermination 
having been conducted.
10. Other Technical Changes
    In the January 17, 2017 final rule, we amended regulations 
throughout 42 CFR part 405, subparts I and J; part 422, subpart M; Part 
423, subparts M and U; and part 478, subpart B by replacing certain 
references to ALJs, ALJ hearing offices, and unspecified entities with 
a reference to OMHA or an OMHA office. We explained that these changes 
were being made 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 (82 FR 4992). However, we 
neglected to revise two existing references to ALJs in Sec.  
405.970(c)(2) and one existing reference to an ALJ in Sec.  405.970(d). 
To correct our oversight, we are proposing to revise Sec.  
405.970(c)(2) and (d) by replacing each instance of the phrase ``to an 
ALJ'' with ``to OMHA'' to clarify that appeals are escalated to OMHA, 
rather than an individual ALJ.
    In the January 17, 2017 final rule, in order to reduce confusion 
with MACs, we revised references to the Medicare Appeals Council 
throughout part 405, subpart I; part 422, subpart M; and part 423, 
subparts M and U by replacing ``MAC'' with ``Council'' (82 FR 4993). 
However, we neglected to change one reference to ``MAC'' in Sec.  
423.1990(d)(2)(ii). Accordingly, we are proposing to revise Sec.  
423.1990(d)(2)(ii) by replacing ``MAC'' with ``Council.''
    In Sec.  423.2010(d)(1), we stated that CMS, IRE, and/or Part D 
plan sponsor participation in an appeal 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. This provision is similar 
to Sec.  405.1010(c)(1), which describes the scope of CMS and CMS 
contractor participation in Medicare Part A and Part B appeals and 
provides, in part, that such participation does not include calling 
witnesses or cross-examining the witnesses of a party to the hearing. 
When finalizing Sec.  423.2010(d)(1) in the January 17, 2017 final 
rule, which we based on Sec.  405.1010(c)(1), we inadvertently retained 
the phrase ``to the hearing'' after ``enrollee''. We believe this 
phrase is unnecessary in this context and reads awkwardly, and are 
proposing to revise Sec.  423.2010(d)(1) to remove it.
    Prior to the January 17, 2017 final rule, Sec.  423.2016(b)(1) 
provided that an ALJ may consider the standard for granting an 
expedited hearing met if a lower-level adjudicator has granted a 
request for an expedited hearing. We revised this paragraph in the 
January 17, 2017 final rule to account for the possibility that a 
request for an expedited appeal could be granted by an attorney 
adjudicator. However, we neglected to correct the existing reference to 
a lower-level adjudicator having granted a request for an expedited 
hearing. Because lower-level adjudicators do not conduct hearings, we 
are proposing to revise Sec.  423.2016(b)(1) by replacing ``hearing'' 
with ``decision''.
    Section 423.2032(c) describes the circumstances in which a coverage 
determination on a drug that was not specified in a request for hearing 
may be added ``to pending appeal.'' We inadvertently omitted the word 
``a'' and are proposing to revise Sec.  423.2032(c) by removing the 
phrase ``to pending appeal'' and adding ``to a pending appeal'' in its 
place.
    Prior to the January 17, 2017 final rule, Sec.  423.2036(g) stated, 
in part, that an ALJ may ask the witnesses at a hearing any questions 
relevant to the issues ``and allow the enrollee or his or her appointed 
representative, as defined at Sec.  423.560.'' In the final rule, we 
redesignated this paragraph as paragraph (d), but neglected to correct 
the missing language at the end of the sentence. For consistency with 
Sec.  405.1036(d), we are proposing to revise Sec.  423.2036(d) by 
adding ``, to do so'' at the end of the paragraph, before the period.
    Section 423.2036(e) discusses what evidence is admissible at the 
hearing, and states that an ALJ may not consider evidence on any change 
in condition of a Part D enrollee after a coverage determination, and 
further provides that if an enrollee wishes for such evidence to be 
considered, the ALJ must remand the case to the Part D IRE as set forth 
in Sec.  423.2034(b)(2). Prior to the January 17, 2017 final rule, 
Sec.  423.2034(b)(2) stated that an ALJ will remand a case to the 
appropriate Part D IRE if the ALJ determines that the enrollee wishes 
evidence on his or her change in condition after the coverage 
determination to be considered in the appeal. In the final rule, we 
moved this provision to Sec.  423.2056(e), but neglected to update the 
cross-reference to it in Sec.  423.2036(e). Accordingly, we are 
proposing to revise Sec.  423.2036(e) to replace the reference to 
``Sec.  423.2034(b)(2)'' with the reference ``Sec.  423.2056(e)''.
    In Sec. Sec.  405.952(b)(4)(i), 405.972(b)(4)(i), 405.1052(a)(4)(i) 
and (b)(3)(i), and 405.1114(c)(1), when discussing determinations as to 
whether a beneficiary's surviving spouse or estate has a remaining 
financial interest in an

[[Page 49524]]

appeal, we refer to limitation on liability under section 1879 of the 
Act as ``limitation of liability.'' To increase consistency with the 
language used in the statute and help reduce confusion as to which 
standard is being applied, we are proposing to replace the phrase 
``limitation of liability'' with ``limitation on liability'' in each of 
these sections.
    We have identified one provision in part 405, subpart I, and two 
provisions in part 423, subpart U, where we used incorrect terminal 
punctuation at the end of a paragraph that is part of a list. To 
correct our errors, we are proposing to revise Sec. Sec.  
405.1046(a)(2)(ii), 423.2002(b)(1), and 423.2010(b)(3)(ii) by replacing 
the period at the end of each paragraph with a semicolon.
    Lastly, we are proposing to revise the authority citations for 
parts 405 and 423 to meet current Office of the Federal Register 
regulatory drafting guidance. The guidance requires that we use only 
the United States Code (U.S.C.) citations for statutory citation unless 
the citation does not exist.

III. Collection of Information Requirements

    This document does not impose information collection requirements, 
that is, reporting, recordkeeping or third-party disclosure 
requirements. In addition, appeals are considered to be an information 
collection requirement that is associated with an administrative action 
pertaining to specific individuals or entities (5 CFR 1320.4(a)(2) and 
(c)). As a result, the burden for preparing and filing an appeal is 
exempt from the requirements and collection burden estimates of the 
Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). Consequently, 
there is no need for review by the Office of Management and Budget 
under the authority of the PRA.

IV. Regulatory Impact Statement

    We have examined the impact of this 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 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), the Congressional 
Review Act (5 U.S.C. 804(2)), and Executive Order 13771 on Reducing 
Regulation and Controlling Regulatory Costs (January 30, 2017).
    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 RIA 
must be prepared for major rules with economically significant effects 
($100 million or more in any 1 year). This rule does not reach the 
economic threshold and thus is not considered a major rule.
    The RFA requires agencies to analyze options for regulatory relief 
of small entities. For purposes of the RFA, small entities include 
small businesses, nonprofit organizations, and small governmental 
jurisdictions. Most hospitals and most other 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 1 year. Individuals and 
states are not included in the definition of a small entity. We are not 
preparing an analysis for the RFA because we have determined, and the 
Secretary certifies, that this proposed rule would not have a 
significant economic impact on a substantial number of small entities.
    In addition, section 1102(b) of the Act requires us to prepare an 
RIA if a rule may have a significant impact on the operations of a 
substantial number of small rural hospitals. 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 are not preparing 
an analysis for section 1102(b) of the Act because we have determined, 
and the Secretary certifies, that this proposed rule would not have a 
significant impact on the operations of a substantial number of small 
rural hospitals.
    Section 202 of the Unfunded Mandates Reform Act of 1995 also 
requires that agencies assess anticipated costs and benefits before 
issuing any rule whose mandates require spending in any 1 year of $100 
million in 1995 dollars, updated annually for inflation. In 2018, that 
threshold is approximately $150 million. This rule would have no 
consequential effect on state, local, or tribal governments or on the 
private sector.
    Executive Order 13132 establishes certain requirements that an 
agency must meet when it promulgates 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. Since this regulation does not impose any costs on state 
or local governments, the requirements of Executive Order 13132 are not 
applicable.
    Executive Order 13771, titled Reducing Regulation and Controlling 
Regulatory Costs, was issued on January 30, 2017 and requires that the 
costs associated with significant new regulations ``shall, to the 
extent permitted by law, be offset by the elimination of existing costs 
associated with at least two prior regulations.'' OMB's interim 
guidance, issued on April 5, 2017, https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/memoranda/2017/M-17-21-OMB.pdf, explains that 
``E.O. 13771 deregulatory actions are not limited to those defined as 
significant under E.O. 12866 or OMB's Final Bulletin on Good Guidance 
Practices.'' This proposed rule, if finalized, is considered a E.O. 
13771 deregulatory action. Consistent with Executive Order 13771 
requirements, when discounted from 2016 to infinity at 7 percent, this 
proposed rule would annually save $9,497,685.00 a year.
    Our proposal to remove the requirement that appellants sign appeal 
requests would result in a slight reduction of burden to appellants by 
allowing them to spend less time developing their appeal request and 
appealing dismissals of appeal requests for lack of a signature to the 
next level of review. Using the data from the number of appeal requests 
received, we estimate that approximately 4,465,000 appeal requests per 
year require a signature. We estimate that it takes 1 minute to sign 
the appeal request. Therefore, the reduction in administrative time 
spent would be 4,465,000 x .016 hour = 71,440.00 hours.
    We used an adjusted hourly wage of $34.66 based on the Bureau of 
Labor Statistics May 2016 website for occupation code 43-9199, ``All 
other office and administrative support workers,'' which gives a mean 
hourly salary of $17.33, which when multiplied by a factor of two to 
include overhead, and fringe benefits, results in $34.66 an hour. The 
consequent cost savings would be 71,440.00 x $34.66 = $2,476,110.40 for 
time spent signing the appeal requests.
    Based on a sampling of the number of appeal requests that are 
dismissed for not containing a signature, we estimated that 284,486 
appeal requests are dismissed per year for not containing a signature 
on them, and 5 minutes to request that the adjudicator vacate the 
dismissal or appeal the dismissal. For appellants, the reduction in

[[Page 49525]]

administrative time spent would be 284,486 x .0083 hours = 23,612 hours 
with a consequent savings of 23,612 hours x $34.66 per hour = 
$818,404.00. The total amount saved for appellants would be 
$3,294,514.40, which consists of $2,476,110.40 for time spent signing 
the appeal requests added to $818,404.00 for time saved appealing the 
dismissed appeal requests.
    When the cost of contractors dismissing appeal requests for the 
lack of signature is factored in, the cost savings becomes $11,757,600. 
This cost is calculated by multiplying the number of appeal requests 
dismissed at the MAC and QIC levels multiplied by the cost that we pay 
the contractors to adjudicate a dismissal. The average cost for a MAC 
to dismiss an appeal request would be $25 x 200,000 appeals dismissed 
for a lack of signature per year, which equates to $5,000,000. The 
average cost for a QIC to dismiss an appeal request would be $80 x 
84,470 appeal requests dismissed for a lack of signature per year, 
which equates to a savings of $6,757,600. When these two costs are 
added together the cost savings becomes $11,757,600.
    In accordance with the provisions of Executive Order 12866, this 
proposed rule was reviewed by the Office of Management and Budget.

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 preamble, 
and, when we proceed with a subsequent document, we will respond to the 
comments in the preamble to that document.

List of Subjects

42 CFR Part 405

    Administrative practice and procedure, Diseases, Health facilities, 
Health professions, Medical devices, Medicare, Reporting and 
recordkeeping, Rural areas, X-rays.

42 CFR Part 423

    Administrative practice and procedures, Emergency medical services, 
Health facilities, Health maintenance organizations (HMO), Medicare, 
Penalties, Privacy, Reporting and recordkeeping requirements.

    For reasons stated in the preamble, CMS proposes to amend 42 CFR 
parts 405 and 423 as follows:

PART 405--FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED

0
1. The authority citation for part 405 is revised to read as follows:

    Authority:  42 U.S.C. 263a, 405(a), 1302, 1320b-12, 1395x, 
1395y(a), 1395ff, 1395hh, 1395kk, 1395rr, and 1395ww(k).


Sec.  405.910   [Amended]

0
2. Section 405.910 is amended--
0
a. In paragraph (c)(5), by removing the phrase ``health insurance 
claim''; and
0
b. In paragraph (e)(4), by removing the reference ``Sec.  
405.906(a)(1)(iv)'' and adding the reference ``Sec.  405.906(a)(4)'' in 
its place.


Sec.  405.926   [Amended]

0
3. Section 405.926 is amended in paragraph (f) by removing the 
reference ``Sec. Sec.  483.5(n) and 483.15'' and adding the reference 
``Sec.  483.5 definition of `transfer and discharge' and Sec.  483.15'' 
in its place.


Sec.  405.944   [Amended]

0
4. Section 405.944 is amended--
0
a. In paragraph (b)(2) by removing the phrase ``health insurance 
claim''; and
0
b. In paragraph (b)(4) by removing the phrase ``and signature''.


Sec.  405.952   [Amended]

0
5. Section 405.952 is amended--
0
a. In paragraph (b)(4)(i) by removing the phrase ``limitation of 
liability'' and adding the phrase ``limitation on liability'' in its 
place; and
0
b. In paragraph (d) by removing the phrase ``6 months'' and adding the 
phrase ``180 calendar days'' in its place.


Sec.  405.964  [Amended]

0
6. Section 405.964 is amended--
0
a. In paragraph (b)(2) by removing the phrase ``health insurance 
claim''; and
0
b. In paragraph (b)(4) by removing the phrase ``and signature''.


Sec.  405.970   [Amended]

0
7. Section 405.970 is amended in paragraphs (c)(2) and (d) by removing 
the phrase ``to an ALJ'' each time it appears and adding the phrase 
``to OMHA'' in its place.


Sec.  405.972  [Amended]

0
8. Section 405.972 is amended--
0
a. In paragraph (b)(4)(i) by removing the phrase ``limitation of 
liability'' and adding the phrase ``limitation on liability'' in its 
place; and
0
b. In paragraph (d) by removing the phrase ``6 months'' and adding the 
phrase ``180 calendar days'' in its place.
0
9. Section 405.1006 is amended by revising paragraph (d)(4) to read as 
follows:


Sec.  405.1006  Amount in controversy required for an ALJ hearing and 
judicial review.

* * * * *
    (d) * * *
    (4) Overpayments. Notwithstanding paragraph (d)(1) 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, or the amount of the revised overpayment if the amount 
originally demanded changes as a result of a subsequent determination 
or appeal, 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, or as 
subsequently revised.
* * * * *
0
10. Section 405.1010 is amended by revising paragraphs (b)(1), 
(b)(3)(ii), (c)(3)(i), and (c)(3)(ii)(A) to read as follows:


Sec.  405.1010  When CMS or its contractors may participate in the 
proceedings on a request for an ALJ hearing.

* * * * *
    (b) * * *
    (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--
    (i) 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
    (ii) The parties who were sent a copy of the notice of 
reconsideration or, for escalated requests for reconsideration, any 
party that filed a request for reconsideration or was found liable for 
the services at issue subsequent to the initial determination.
* * * * *
    (3) * * *
    (ii) If a hearing is scheduled, no later than 10 calendar days 
after receipt of the notice of hearing by the QIC or another contractor 
designated by CMS to receive the notice of hearing.
    (c) * * *
    (3) * * *
    (i) Unless the ALJ or attorney adjudicator grants additional time 
to submit the position paper or written testimony, a position paper or 
written testimony must be submitted within 14 calendar days of an 
election to

[[Page 49526]]

participate if no hearing has been scheduled, or no later than 5 
calendar days prior to the hearing if a hearing is scheduled.
    (ii) * * *
    (A) The parties that are required to be sent a copy of the notice 
of intent to participate in accordance with paragraph (b)(1) of this 
section, if the position paper or written testimony is being submitted 
before receipt of a notice of hearing for the appeal; or
* * * * *


Sec.  405.1012  [Amended]

0
11. Section 405.1012 is amended--
0
a. In paragraph (a)(1) by removing the phrase ``after the QIC receives 
the notice of hearing'' and adding the phrase ``after receipt of the 
notice of hearing by the QIC or another contractor designated by CMS to 
receive the notice of hearing'' in its place;
0
b. In paragraph (b) by removing the phrase ``identified in the notice 
of hearing'' and adding the phrase ``who were sent a copy of the notice 
of hearing'' in its place; and
0
c. In paragraph (e)(1) by removing the phrase ``ALJ or attorney 
adjudicator'' and adding the term ``ALJ'' in its place.


Sec.  405.1014  [Amended]

0
12. Section 405.1014 is amended--
0
a. In paragraph (a)(1)(i) by removing the phrase ``health insurance 
claim''; and
0
b. In paragraph (e)(2) by removing the phrase ``with the request for 
hearing or request for review of a QIC dismissal'' and adding the 
phrase ``with the request for hearing or request for review of a QIC 
dismissal, or upon notice that the request may be dismissed because it 
was not timely filed,'' in its place.
0
13. Section 405.1020 is amended by revising paragraph (c)(1), adding 
paragraph (e)(5), and revising paragraph (i)(5) to read as follows:


Sec.  405.1020   Time and place for a hearing before an ALJ.

* * * * *
    (c) * * *
    (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 or from which the request for 
reconsideration was escalated, or another contractor designated to 
receive the notice of hearing by CMS; and CMS or a contractor that 
elected to participate in the proceedings in accordance with Sec.  
405.1010(b) or that the ALJ believes would be beneficial to the 
hearing, advising them of the proposed time and place of the hearing.
* * * * *
    (e) * * *
    (5) If the party's objection to the place of the hearing includes a 
request for an in-person or VTC hearing, the objection and request are 
considered in paragraph (i) of this section.
* * * * *
    (i) * * *
    (5) The ALJ may grant the request, with the concurrence of the 
Chief ALJ or designee if the request was for an in-person hearing, 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. 
Good cause is not required for a request for VTC hearing made by an 
unrepresented beneficiary who filed the request for hearing and objects 
to an ALJ's offer to conduct a hearing by telephone.
* * * * *
0
14. Section 405.1034 is amended by revising paragraph (a)(1) to read as 
follows:


Sec.  405.1034  Requesting information from the QIC.

    (a) * * *
    (1) Official copies of redeterminations and reconsiderations that 
were conducted on the appealed claims, and official copies of 
dismissals of a request for redetermination or reconsideration, can be 
provided only by CMS or its contractors. Prior to issuing a request for 
information to the QIC, OMHA will confirm whether an electronic copy of 
the redetermination, reconsideration, or dismissal is available in the 
official system of record, and if so will accept the electronic copy as 
an official copy.
* * * * *


Sec.  405.1046  [Amended]

0
15. Section 405.1046 is amended in paragraph (a)(2)(ii) by removing the 
period at the end of the paragraph and adding a semicolon in its place.
0
16. Section 405.1052 is amended by revising paragraphs (a)(3), 
(a)(4)(i), (a)(5) and (6), (b)(3)(i), (d), and (e) 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) * * *
    (3) The party did not request a hearing within the stated time 
period and the ALJ has not found good cause for extending the deadline, 
as provided in Sec.  405.1014(e).
    (4) * * *
    (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 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 on liability provisions based on the denial of the services 
at issue.
* * * * *
    (5) The ALJ 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 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.
* * * * *
    (b) * * *
    (3) * * *
    (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 on liability provisions based on the 
denial of the services at issue.
* * * * *
    (d) Notice of dismissal. OMHA mails or otherwise transmits a 
written notice of the dismissal of the hearing or review request to the 
appellant, all parties who were sent a copy of the request for hearing 
or review at their last known address, and to CMS or a CMS contractor 
that is a party to the proceedings on a request for hearing. 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.

[[Page 49527]]

    (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 180 calendar days 
of the date of the notice of dismissal.
0
17. Section 405.1056 is amended by revising paragraphs (d), (f), and 
(g) to read as follows:


Sec.  405.1056  Remands of requests for hearing and requests for 
review.

* * * * *
    (d) Remanding a QIC's dismissal of a request for reconsideration. 
(1) 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.
    (2) If an official copy of the notice of dismissal or case file 
cannot be obtained from the QIC, an ALJ or attorney adjudicator may 
also remand a request for review of a dismissal in accordance with the 
procedures in paragraph (a) of this section.
* * * * *
    (f) Notice of remand. OMHA mails or otherwise transmits a written 
notice of the remand of the request for hearing or request for review 
to the appellant, 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, unless the remand was issued under 
paragraph (d)(1) of this section.
    (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. The review of remand procedures provided for 
in this paragraph are not available for and do not apply to remands 
that are issued under paragraph (d)(1) of this section.
0
18. Section 405.1110 is amended--
0
a. In paragraph (a) by removing the phrase ``after the date'' and 
adding the phrase ``of receipt'' in its place; and
0
b. In paragraph (b)(2) by removing the term ``issued'' and adding the 
term ``received'' in its place.
0
c. Adding paragraph (e).
    The addition reads as follows:


Sec.  405.1110   Council review on its own motion.

* * * * *
    (e) Referral timeframe. 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.


Sec.  405.1112  [Amended]

0
19. Section 405.1112 is amended in paragraph (a)--
0
a. By removing the phrase ``health insurance claim''; and
0
b. By removing the phrase ``and signature''.


Sec.  405.1114   [Amended]

0
20. Section 405.1114 is amended in paragraph (c)(1) by removing the 
phrase ``limitation of liability'' and adding the phrase ``limitation 
on liability'' in its place.

PART 423--VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT

0
21. The authority citation for part 423 is revised to read as follows:

    Authority:  42 U.S.C. 1302, 1306, 1395w-101 through 1395w-152, 
and 1395hh.


Sec.  423.562   [Amended]

0
22. Section 423.562 is amended--
0
a. In paragraph (b)(4)(iv) by removing the reference ``Sec.  423.1970'' 
and adding the reference ``Sec.  423.2006'' in its place;
0
b. In paragraph (b)(4)(v) by removing the reference ``Sec.  423.1974'' 
and adding the reference ``Sec.  423.2100'' in its place; and
0
c. In paragraph (b)(4)(vi) by removing the reference ``Sec.  423.1976'' 
and adding the cross-reference ``Sec.  423.2006'' in its place.


Sec.  423.576  [Amended]

0
23. Section 423.576 is amended by removing the reference ``Sec.  
423.1970 through Sec.  423.1976'' and adding the reference ``Sec.  
423.2000 through Sec.  423.2140'' in its place.


Sec.  423.602  [Amended]

0
24. Section 423.602 is amended in paragraph (b)(2)by removing the 
reference ``Sec.  423.1970'' and adding the cross ``Sec.  423.2006'' in 
its place.


Sec.  423.604   [Amended]

0
25. Section 423.604 is amended by removing the reference ``Sec.  
423.1972'' and adding the reference ``Sec.  423.2014'' in its place.


Sec.  423.1970  [Removed and reserved]

0
26. Section 423.1970 is removed and reserved.


Sec.  423.1972  [Removed and reserved]

0
27. Section 423.1972 is removed and reserved.


Sec.  423.1974   [Removed and reserved]

0
28. Section 423.1974 is removed and reserved.


Sec.  423.1976   [Removed and reserved]

0
29. Section 423.1976 is removed and reserved.


Sec.  423.1984  [Amended]

0
30. Section 423.1984 is amended--
0
a. In paragraph (c) by removing the reference ``Sec.  423.1970 through 
Sec.  423.1972 and''; and
0
b. In paragraph (d) by removing the phrase ``Sec.  423.1974 and''.


Sec.  423.1990  [Amended]

0
31. Section 423.1990 is amended--
0
a. In paragraph (b)(3) by removing the phrase ``established annually by 
the Secretary'' and adding the phrase ``specified in Sec.  423.2006'' 
in its place; and
0
b. In paragraph (d)(2)(ii) by removing the term ``MAC'' and adding the 
term ``Council'' in its place.
0
32. Section 423.2002 is amended--
0
a. By revising paragraphs (a) introductory text and (a)(2);
0
b. In paragraph (b)(1) by removing the period at the end of the 
paragraph and adding a semicolon in its place; and
0
c. By revising paragraph (b)(3).
    The revisions read as follows.


Sec.  423.2002   Right to an ALJ hearing.

    (a) An enrollee who is dissatisfied with the IRE reconsideration 
determination has a right to a hearing before an ALJ if--
* * * * *
    (2) An enrollee meets the amount in controversy requirements of 
Sec.  423.2006.
* * * * *
    (b) * * *
* * * * *
    (3) An enrollee meets the amount in controversy requirements of 
Sec.  423.2006.
* * * * *


Sec.  423.2004  [Amended]

0
33. Section 423.2004 is amended in paragraph (a)(2) by removing the 
reference ``Sec.  423.1970'' and adding the reference ``Sec.  
423.2006'' in its place.
0
34. Section 423.2006 is added to read as follows:


Sec.  423.2006  Amount in controversy required for an ALJ hearing and 
judicial review.

    (a) ALJ review. To be entitled to a hearing before an ALJ, an 
enrollee must meet the amount in controversy requirements of this 
section.
    (1) For ALJ hearing requests, the required amount remaining in 
controversy must be $100, increased by the percentage increase in the 
medical

[[Page 49528]]

care component of the Consumer Price Index for All Urban Consumers 
(U.S. city average) as measured from July 2003 to the July preceding 
the current year involved.
    (2) If the figure in paragraph (a)(1) of this section is not a 
multiple of $10, it is rounded to the nearest multiple of $10. The 
Secretary will publish changes to the amount in controversy requirement 
in the Federal Register when necessary.
    (b) Judicial review. To be entitled to judicial review, the 
enrollee must meet the amount in controversy requirements of this 
subpart at the time it requests judicial review. For review requests, 
the required amount remaining in controversy must be $1,000 or more, 
adjusted as specified in paragraphs (a)(1) and (2) of this section.
    (c) Calculating the amount remaining in controversy. (1) If the 
basis for the appeal is the refusal by the Part D plan sponsor to 
provide drug benefits, the projected value of those benefits is used to 
compute the amount remaining in controversy. The projected value of a 
Part D drug or drugs must include any costs the enrollee could incur 
based on the number of refills prescribed for the drug(s) in dispute 
during the plan year.
    (2) If the basis for the appeal is an at-risk determination made 
under a drug management program in accordance with Sec.  423.153(f), 
the projected value of the drugs subject to the drug management program 
is used to compute the amount remaining in controversy. The projected 
value of the drugs subject to the drug management program shall include 
the value of any refills prescribed for the drug(s) in dispute during 
the plan year.
    (d) Aggregating appeals to meet the amount in controversy. (1) 
Enrollee. Two or more appeals may be aggregated by an enrollee to meet 
the amount in controversy for an ALJ hearing if--
    (i) The appeals have previously been reconsidered by an IRE;
    (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) Multiple enrollees. Two or more appeals may be aggregated by 
multiple enrollees to meet the amount in controversy for an ALJ hearing 
if--
    (i) The appeals have previously been reconsidered by an IRE;
    (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.


Sec.  423.2010   [Amended]

0
35. Section 423.2010 is amended--
0
a. In paragraph (b)(3)(ii) by removing the period at the end of the 
paragraph and adding a semicolon in its place; and
0
b. In paragraph (d)(1) by removing the phrase ``to the hearing''.
0
36. Section 423.2014 is amended by revising paragraphs (a)(1)(i), (d) 
introductory text, and (e)(1) and (3) to read as follows:


Sec.  423.2014  Request for an ALJ hearing or a review of an IRE 
dismissal.

    (a) * * *
    (1) * * *
    (i) The name, address, telephone number, and Medicare number of the 
enrollee.
* * * * *
    (d) When and where to file. The request for an ALJ hearing after an 
IRE reconsideration or request for review of an IRE dismissal must be 
filed:
* * * * *
    (e) * * *
    (1) 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.
* * * * *
    (3) The request must be filed with the office specified in the 
notice of reconsideration or dismissal, 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 request for 
review of an IRE dismissal, or upon notice that the request may be 
dismissed because it was not timely filed.
* * * * *


Sec.  423.2016  [Amended]

0
37. Section 423.2016 is amended in paragraph (b)(1) by removing the 
term ``hearing'' and adding the term ``decision'' in its place.
0
38. Section 423.2020 is amended by revising paragraph (a), adding 
paragraph (e)(5), and revising paragraph (i)(5) to read as follows:


Sec.  423.2020   Time and place for a hearing before an ALJ.

    (a) General. The ALJ sets the time and place for the hearing, and 
may change the time and place, if necessary.
* * * * *
    (e) * * *
    (5) If the enrollee's objection to the place of the hearing 
includes a request for an in-person or video-teleconferencing hearing, 
the objection and request are considered in paragraph (i) of this 
section.
* * * * *
    (i) * * *
    (5) The ALJ may grant the request, with the concurrence of the 
Chief ALJ or designee if the request was for an in-person hearing, 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. Good cause is not required for a request for video-
teleconferencing hearing made by an unrepresented enrollee who filed 
the request for hearing and objects to an ALJ's offer to conduct a 
hearing by telephone.
* * * * *


Sec.  423.2032   [Amended]

0
39. Section 423.2032 is amended in paragraph (c) by removing the phrase 
``to pending appeal'' and adding the phrase ``to a pending appeal'' in 
its place.
0
40. Section 423.2034 is amended by revising paragraph (a)(1) to read as 
follows:


Sec.  423.2034  Requesting information from the IRE.

    (a) * * *
    (1) Official copies of redeterminations and reconsiderations that 
were conducted on the appealed issues, and official copies of 
dismissals of a request for redetermination or reconsideration, can be 
provided only by CMS, the IRE, and/or the Part D plan sponsor. Prior to 
issuing a request for information to the IRE, OMHA will confirm whether 
an electronic copy of the missing redetermination, reconsideration, or 
dismissal is available in the official system of record, and if so will 
accept the electronic copy as an official copy.
* * * * *

[[Page 49529]]

Sec.  423.2036   [Amended]

0
41. Section 423.2036 is amended--
0
a. In paragraph (d) by removing the reference ``Sec.  423.560.'' and 
adding the phrase ``Sec.  423.560, to do so.'' in its place; and
0
b. In paragraph (e) by removing the reference ``Sec.  423.2034(b)(2)'' 
and adding the reference ``Sec.  423.2056(e)'' in its place.


Sec.  423.2044  [Amended]

0
42. Section 423.2044 is amended in paragraph (c) by removing the 
reference ``Sec.  423.1970'' and adding the reference ``Sec.  
423.2006'' in its place.


Sec.  423.2052   [Amended]

0
43. Section 423.2052 is amended--
0
a. In paragraph (a)(3) by removing the phrase ``or attorney 
adjudicator'';
0
b. In paragraph (a)(5) by removing the phrase ``or attorney 
adjudicator'' the first time it appears;
0
c. In paragraph (a)(6) by removing the phrase ``or attorney 
adjudicator''; and
0
d. In paragraph (e) by removing the phrase ``6 months'' and adding the 
phrase ``180 calendar days'' in its place.
0
44. Section 423.2056 is amended by revising paragraphs (b), (d), (f), 
and (g) to read as follows:


Sec.  423.2056  Remands of requests for hearing and requests for 
review.

* * * * *
    (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 readjudicate the request for 
reconsideration, unless the request for redetermination was forwarded 
to the IRE in accordance with Sec.  423.590(c) or (e) without a 
redetermination having been conducted.
* * * * *
    (d) Remanding an IRE's dismissal of a request for reconsideration. 
(1) 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.
    (2) If an official copy of the notice of dismissal or case file 
cannot be obtained from the IRE, an ALJ or attorney adjudicator may 
also remand a request for review of a dismissal in accordance with the 
procedures in paragraph (a) of this section.
* * * * *
    (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, unless the remand was issued under paragraph (d)(1) of this 
section.
    (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. The review of remand 
procedures provided for in this paragraph are not available for and do 
not apply to remands that are issued in paragraph (d)(1) of this 
section.
0
45. Section 423.2100 is amended by revising paragraph (a) to read as 
follows:


Sec.  423.2100  Medicare Appeals Council review: general.

    (a) 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.
* * * * *
0
46. Section 423.2110 is amended--
0
a. In paragraph (a) introductory text by removing the phrase ``after 
the date'' and adding the phrase ``of receipt'' in its place; and
0
b. In paragraph (b)(2) by removing the term ``issued'' and adding the 
term ``received'' in its place.
0
c. Adding paragraph (e).
    The addition reads as follows:


Sec.  423.2110  Council review on its own motion.

* * * * *
    (e) Referral timeframe. 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.


Sec.  423.2112   [Amended]

0
47. Section 423.2112 is amended in paragraph (a)(4)--
0
a. By removing the phrase ``health insurance claim''; and
0
b. By removing the phrase ``and signature''.
0
48. Section 423.2136 is amended by revising paragraphs (a) and (b)(1) 
to read as follows.


Sec.  423.2136   Judicial review.

    (a) General rule. (1) Review of Council decision. To the extent 
authorized by sections 1876(c)(5)(B) and 1860D-4(h) of the Act, an 
enrollee may obtain a court review of a Council decision if--
    (i) It is a final decision of the Secretary; and
    (ii) The amount in controversy meets the threshold requirements of 
Sec.  423.2006.
    (2) Review of ALJ's or attorney adjudicator's decision. To the 
extent authorized by sections 1876(c)(5)(B) and 1860D-4(h) of the Act, 
the enrollee may request judicial review of an ALJ's or attorney 
adjudicator's decision if--
    (i) The Council denied the enrollee's request for review; and
    (ii) The amount in controversy meets the threshold requirements of 
Sec.  423.2006.
    (b) * * *
    (1) Any civil action described in paragraph (a) of this section 
must be filed in the District Court of the United States for the 
judicial district in which the enrollee resides.
* * * * *

    Dated: July 16, 2018.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
    Dated: September 5, 2018.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
[FR Doc. 2018-21223 Filed 9-28-18; 11:15 am]
BILLING CODE 4120-01-P