Medicare Program; Changes to the Medicare Claims and Medicare Prescription Drug Coverage Determination Appeals Procedures, 19855-19874 [2019-09114]

Agencies

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

[Federal Register Volume 84, Number 88 (Tuesday, May 7, 2019)]
[Rules and Regulations]
[Pages 19855-19874]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-09114]



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Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents 
having general applicability and legal effect, most of which are keyed 
to and codified in the Code of Federal Regulations, which is published 
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents. 

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Federal Register / Vol. 84, No. 88 / Tuesday, May 7, 2019 / Rules and 
Regulations

[[Page 19855]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 405 and 423

[CMS-4174-F]
RIN 0938-AT27


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

AGENCY: Centers for Medicare & Medicaid Services, Department of Health 
and Human Services.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This final rule revises 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 help to 
streamline the appeals process and reduce administrative burden on 
providers, suppliers, beneficiaries, and appeal adjudicators. These 
revisions, which include technical corrections, also help to ensure the 
regulations are clearly arranged and written to give stakeholders a 
better understanding of the appeals process.

DATES: These regulations are effective on July 8, 2019.

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

SUPPLEMENTARY INFORMATION:

I. Background

    As specified under sections 1869 and 1860D-4 of the Social Security 
Act (the Act) and the 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 certain requirements, including a 
minimum amount in controversy (AIC), are 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 previously 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 42 CFR 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 
dissatisfied 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.

[[Page 19856]]

    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 Rule and Summary of and Responses to 
Public Comments

A. Introduction

    In the October 2, 2018 Federal Register (83 FR 49513), we published 
a proposed rule that, if finalized, would make regulatory changes to 
the Medicare Part A and Part B and Part D appeals processes to help 
streamline the appeals process and reduce administrative burden on 
providers, suppliers, beneficiaries, and appeal adjudicators. If 
finalized, these proposed revisions, which included technical 
corrections, would also help to ensure the regulations are clearly 
arranged and written to give stakeholders a better understanding of the 
appeals process.
    We received approximately 15 timely pieces of correspondence on the 
proposed rule. Commenters included insurance industry associations and 
organizations, beneficiaries, providers and provider advocacy groups, 
and health insurance plans. Of the comments received, most commenters 
supported the rule, specifically the elimination of the requirement 
that appellants sign appeal requests.
    We also note that some of the public comments were outside of the 
scope of the proposed rule. These out-of-scope public comments are not 
addressed in this final rule. Summaries of the public comments that are 
within the scope of the proposed rule and our responses to those public 
comments and our final policies are set forth as follows.

B. Discussion of the Proposed Rule

1. 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 AIC 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 through 
405.1058 and 423.1968 through 423.2063). 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 
through 405.1140 and 423.2100 through 423.2140).
    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 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 proposed 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 proposed 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 (83 FR 49525 through 49529).
    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, as we explained 
in the proposed rule (83 FR 49515), 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, we stated that 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). We explained that 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, we stated that it is not necessary 
that this information be included in the redetermination appeal 
request.
    By contrast, we stated in the proposed rule (83 FR 49515) that 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. We explained that 
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.
    As discussed in the proposed rule (83 FR 49515), eliminating the 
requirement that appellants sign their appeal requests would reduce the 
burden of

[[Page 19857]]

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) and 405.972(b)). We stated that 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. As a result, we proposed to eliminate the requirement that 
appellants sign their appeal requests.
    We stated in the proposed rule that, 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. We explained 
that, 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.
    As we explained in the proposed rule (83 FR 49515), 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. In 
addition, we stated that 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 stated in the proposed rule that we believe there is no 
need for a signature on an appeal request at this time and we proposed 
to eliminate that requirement (83 FR 49515). However, we noted that 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 reexamine the possibility of adding the 
requirement back in. However, we explained that, given that our 
existing statutory authority limits our ability to enforce certain 
attestations, we found the signature requirement unnecessary.
    We received several comments on this proposal. Following are 
summaries of the comments we received and responses to these comments.
    Comment: The commenters supported the proposed changes to 
Sec. Sec.  405.944, 405.964, 405.1112, and 423.2112 to remove the 
requirement that appellants sign appeal requests, stating its potential 
to streamline the appeals process and reduce burden.
    Response: We appreciate the commenters' support for elimination of 
the requirement that appellants sign the appeal request and agree that 
it will streamline the appeals process and reduce burden.
    After review and consideration of the comments received, and for 
the reasons discussed previously and in the proposed rule, we are 
finalizing without modification our proposed revisions to Sec. Sec.  
405.944(b)(4), 405.964(b)(4), 405.1112(a), and 423.2112(a)(4).
2. 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), 405.1052(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. 
We stated in the proposed rule (83 FR 49515) that this allows 
sufficient time for adjudicators to carefully evaluate their dismissals 
while taking into account the principle of administrative finality.
    As discussed in the proposed rule (83 FR 49515), 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, we stated that 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, we stated that applying a 
timeframe based on days, rather than months, leads to more consistency 
in interpretation and actual timeframes. We explained that 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 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 part 405, 
subpart I, and part 423, subpart U, we proposed (83 FR 49525 through 
49529) 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).
    We received no comments on these proposals. Accordingly, for the 
reasons discussed previously and in the proposed rule, we are 
finalizing without modification our proposed revisions to Sec. Sec.  
405.952(d), 405.972(d), 405.1052(e), and 423.2052(e).
3. 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 issued 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, at the time of the proposed rule, 
was not on Medicare cards. As discussed in the proposed rule (83 FR 
49516), 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 proposed 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 (83 FR 
49516). Accordingly, we proposed (83 FR 49527 through 49529) 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).
    We received no comments on this proposal. Accordingly, for the 
reasons discussed previously and in the

[[Page 19858]]

proposed rule, we are finalizing our proposed revisions without 
modification to 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).
4. 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 proposed 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 (83 FR 49516 through 49518).
    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 proposed to remove Sec.  423.1970 (83 FR 49527). We stated 
that 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 proposed 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 
(83 FR 49527 and 49528).
    In addition, we proposed 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 (83 FR 
49528).
    As discussed in the proposed rule (83 FR 49516), 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 we 
proposed to remove from Sec.  423.1970(a), we also proposed 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 (83 FR 49527).
    In order to further increase consistency with Sec.  405.1006 and 
consolidate the Medicare Part D appeals rules regarding the AIC, we 
proposed 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 
determinations, without the need for multiple statutory and regulatory 
cross-references, we proposed that new Sec.  423.2006 would include the 
following (83 FR 49527 and 49528):
     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 proposed 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, (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'' (83 FR 49527 through 49529).
    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

[[Page 19859]]

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.
    As we stated in the proposed rule (83 FR 49517), 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 proposed to remove 
Sec.  423.1972 in its entirety (83 FR 49527). As a part of this 
proposed change, we also proposed 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 stated in 
the proposed rule (83 FR 495174) that 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. We further noted 
that, 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. We stated in the proposed rule (83 FR 49517) that this 
provision is similar to Sec.  423.2100, titled ``Medicare Appeals 
Council review: general.'' To eliminate the redundancy, we proposed (83 
FR 49529) 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 proposed (83 FR 49527) 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.
    As we stated in the proposed rule (83 FR 49517), 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 proposed 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 proposed 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 proposed 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 sought comment on these proposed changes.
    In summary, we proposed 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.
Sec.   423.1970(c)................                          proposed new Sec.
                                                            423.2006(c).
                                                           Remove and incorporate at
                                                            proposed new Sec.
                                                            423.2006(d)..
--------------------------------------------------------------------------------------
N/A...............................  Sec.   423.2006(a)...  Add language concerning
N/A...............................  Sec.   423.2006(b)...   AIC computation not
                                                            previously outlined in
                                                            part 423.
----------------------------------------------------------------------------------------------------------------
Sec.   423.1972(a)................  N/A..................  Remove....................  Similar language exists
Sec.   423.1972(b)................                                                      in Sec.  Sec.
Sec.   423.1972(c)(1).............                                                      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.   423.1976(b)................                          Sec.   423.2136(a)(2).
                                                           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).
----------------------------------------------------------------------------------------------------------------


[[Page 19860]]

    We received no comments on the proposals described previously. 
Accordingly, for the reasons discussed previously and in the proposed 
rule, we are finalizing the proposed revisions without modification.
5. Change to Timeframe for Council Referral (Sec. Sec.  405.1110 and 
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.
    As we discussed in the proposed rule (83 FR 49518), 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. We explained that 
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 proposed 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 (83 FR 49527 and 49529). We stated that 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. In addition, we 
stated that 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 proposed 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 (83 FR 49529). We explained that 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. We stated that 
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 (83 FR 49518).
    For these reasons, we proposed to revise the Council referral 
timeframes in Sec. Sec.  405.1110(a) and (b)(2) and 423.2110(a) and 
(b)(2), and proposed to add Sec. Sec.  405.1110(e) and 423.2110(e) as 
discussed previously (83 FR 49529).
    Following is a summary of the comment we received and our response 
to this comment.
    Comment: A commenter expressed concern that changing the timeframe 
to begin after the decision is received could further delay the 
Council's ultimate decision on the case, if the Council accepts the 
referral.
    Response: We acknowledge that this change in timeframe could result 
in a delayed decision by the Council on the case. However, we believe 
that CMS and its contractors need sufficient time to do a thorough 
review of each appeal. We believe that the need for CMS and its 
contractors to conduct a thorough review outweighs any concerns that 
may arise from a slight delay that appellants may experience in 
receiving their decision by the Council, if the Council ultimately 
accepts the referral.
    Accordingly, after review and consideration of the comment 
received, and for the reasons discussed previously and in the proposed 
rule, we are finalizing without modification our proposed revisions to 
Sec. Sec.  405.1110(a) and (b)(2) and 423.2110(a) and (b)(2), and our 
proposals to add Sec. Sec.  405.1110(e) and 423.2110(e).
6. Technical Correction to Regulation Regarding Duration of Appointed 
Representative in a Medicare Secondary Payer Recovery Claim (Sec.  
405.910)
    The regulation at Sec.  405.910 sets forth rules addressing the 
appointment of representatives in a Medicare Parts A and B claims 
appeals, including for secondary payer recovery claims. Specific rules 
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. As we stated in the proposed rule 
(83 FR 49518), this citation is an incorrect cross-reference; and the 
correct cross-reference is Sec.  405.906(a)(4). We proposed to revise 
Sec.  405.910(e)(4) to correct the cross-reference (83 FR 49525). We 
stated in the proposed rule that this proposed correction would not 
alter any existing processes or procedures within the Medicare claims 
appeals process.
    We received no comments on this proposal. Accordingly, for the 
reasons discussed previously and in the proposed rule, we are 
finalizing the proposed revision without modification to Sec.  
405.910(e)(4).
7. Technical Correction To Actions That Are Not Initial Determinations 
(Sec.  405.926)
    The regulation at Sec.  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. 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, as we stated in the 
proposed rule (83 FR 49519), the citation of Sec.  483.5(n) is an 
incorrect cross-reference.
    To correct this error, we proposed 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' '' (83 FR 49525). We stated

[[Page 19861]]

that this proposed technical correction would serve to correct an 
incorrect citation. We further explained that it would not alter any 
existing processes or procedures within the Medicare claims appeals 
process (83 FR 49518).
    We received no comments on this proposal. Accordingly, for the 
reasons discussed previously and in the proposed rule, we are 
finalizing the proposed revision without modification to Sec.  
405.926(f).
8. 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 sought to help ensure the provisions are implemented as 
intended, provide clarification, and correct technical errors and 
omissions. Our proposed changes were as follows.
a. 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.
    As discussed in the proposed rule (83 FR 49519), 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. We explained that, 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 proposed 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 (83 FR 
49525). For appeals involving an estimated overpayment amount 
determined through the use of statistical sampling and extrapolation, 
we further proposed 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 (83 FR 49525).
    Following is a summary of the comment we received and our response 
to this comment.
    Comment: A commenter expressed concern that CMS and MACs do not 
always issue demand letters when the amount of an overpayment changes. 
The commenter requested that CMS require MACs to issue revised demand 
letters whenever an appeal decision is made that would increase or 
decrease the amount of an identified overpayment, and to clarify what 
the AIC would be if no revised demand letter is issued.
    Response: The commenter's request to require MACs to issue revised 
demand letters whenever an appeal decision is made that would increase 
or decrease the amount of an identified overpayment is beyond the scope 
of the proposed rule, and thus we are not addressing it in this final 
rule.
    With regard to the commenter's request to clarify what the AIC 
would be if no revised demand letter is issued, as we explained in the 
preamble to the proposed rule (83 FR 49519), the amount of an 
overpayment or estimated overpayment specified in a demand letter might 
change throughout the administrative appeals process as a result of 
appeals determinations, or outside the appeals process (for example, 
following a discussion period with the contractor that initially 
determined the overpayment). We further explained that, 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 appeals 
process. It is for this reason that we proposed to revise Sec.  
405.1006(d)(4) to account for situations in which the amount of the 
overpayment or estimated overpayment specified in the demand letter 
(original or revised) no longer accurately reflects the AIC for an 
appeal. In these circumstances, an OMHA adjudicator would consider the 
amount of the overpayment or estimated overpayment specified in the 
most recent demand letter, factoring in any additional denied items or 
services, payment reductions, or payments awarded subsequent to the 
issuance of the demand letter. For purposes of determining whether an 
appeal meets the minimum AIC required for an ALJ hearing or review of a 
dismissal, we believe the demand letter, coupled with other available 
billing or payment information, would provide appellants and 
adjudicators with the necessary information to determine, or at least 
approximate, the effect of subsequent determinations or appeals and the 
amount of the revised overpayment. For estimated overpayments 
determined through the use of statistical sampling and extrapolation, 
because these estimated overpayments tend to far exceed the minimum 
AIC, we believe it would generally be unnecessary to calculate the 
exact amount of the revised estimate.
    After review and consideration of the comments received, for the 
reasons discussed previously and in the proposed rule, we are 
finalizing the

[[Page 19862]]

proposed revisions without modification to Sec.  405.1006(d)(4).
b. Submissions by CMS and CMS Contractors (Sec. Sec.  405.1010 and 
405.1012)
    In Sec.  405.1010(b)(1), we state 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.
    As discussed in the proposed rule (83 FR 49519), 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 proposed 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 
stated we did 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 proposed 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 (83 FR 
49525 and 49526). We proposed 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). We noted that no corresponding revisions to 
Sec.  423.2010 are needed because escalation is not available in 
Medicare Part D appeals (83 FR 49519).
    In Sec.  405.1010(b)(3)(ii), we state 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 hearing.'' As discussed 
in the proposed rule (83 FR 49519 and 49520), 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 stated that 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 stated that we 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 proposed to 
revise Sec.  405.1020(c)(1) to provide for this flexibility (83 FR 
49526).
    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 proposed 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 (83 FR 49526). We noted that 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 (83 FR 49520).
    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 part 405 and 
part 423, we proposed 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 (83 FR 49525 and 49526).
    In Sec.  405.1012(b), we state 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

[[Page 19863]]

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 proposed to revise Sec.  
405.1012(b) by replacing the language ``identified in the notice of 
hearing'' with ``who were sent a copy of the notice of hearing'' (83 FR 
49526). As we noted in the proposed rule, 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 (83 FR 49520).
    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 proposed in 
Sec.  405.1012(e)(1) to replace the phrase ``ALJ or attorney 
adjudicator'' with ``ALJ'' (83 FR 49526). As we noted, 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 
(83 FR 49520).
    Following is a summary of the comment we received and our response 
to this comment.
    Comment: One commenter opposed the proposal to permit a contractor, 
other than the QIC, to receive notices of hearing because the commenter 
believed that allowing flexibility for CMS to designate another 
contractor to receive notices of hearing would undermine QIC 
accountability, as the commenter believed that the QIC that rendered 
the decision on appeal should be a party to the hearing. The commenter 
further stated that the proposal to allow CMS to designate another 
contractor, other than the QIC, to receive notices of hearing rather 
than the QIC would waste time, add complexity, and prejudice providers 
by allowing CMS to select a different contractor shortly before the 
hearing. The commenter also noted that the current time frame for CMS 
or a CMS contractor to submit a position paper or written testimony 
when a hearing is scheduled (no later than 5 calendar days prior to a 
hearing if a hearing has been scheduled, unless the time frame is 
extended by an ALJ) does not afford appellants enough time to review 
and address any new issues raised in the position paper or written 
testimony. The commenter also pointed out that on page 49520 of the 
preamble to the proposed rule, we inadvertently stated that were 
proposed to revise Sec.  405.1012(b)(2), but that paragraph does not 
exist.
    Response: We do not agree with the commenter that our proposal to 
allow CMS the flexibility to designate another contractor, other than 
the QIC, to receive notices of hearing would undermine QIC 
accountability, add complexity to the hearing process, or unfairly 
prejudice providers. It is possible that the commenter misunderstood 
our proposal as a proposal to replace the QIC who adjudicated the 
appeal with another contractor as a party to the hearing; however, this 
was not what we proposed. Rather, we proposed that CMS have flexibility 
to replace the QIC in its administrative role of distributing hearing 
requests.
    Providing CMS with the flexibility to designate a different 
contractor to receive the notice of hearing does not add complexity to 
the hearing process. When a hearing is scheduled under the current 
regulations, OMHA sends the notice of hearing to a single CMS 
contractor. That contractor is then responsible for disseminating 
notice of the hearing to other CMS contractors, such as the MAC that 
issued the redetermination. This proposal, which we are finalizing, 
will allow CMS to assign the administrative responsibility of notifying 
the appropriate entities to a contractor other than the QIC. The QIC 
will still receive notice of the hearing, and would still have the 
opportunity to elect to participate in or be a party to the appeal, as 
applicable. Only CMS contractors that were involved with the claims, 
determinations, and decisions on appeal, or their successors, are 
notified of a hearing under the current process, and only those 
entities would be notified under the process we are finalizing.
    Under current Sec. Sec.  405.1010 and 405.1012, CMS or any of its 
contractors may elect to participate in the proceedings on a request 
for an ALJ hearing, and one of these entities may also elect to be a 
party to the proceedings if a hearing is scheduled and the appellant is 
not an unrepresented beneficiary. Neither the QIC nor any other CMS 
contractor is required to be a party (or a non-party participant) to a 
hearing. To join the proceedings as a party, a CMS contractor must 
affirmatively elect party status during the appropriate timeframe, and 
must notify the other parties identified in the notice of hearing of 
its intent to be a party to the hearing. Section 405.1012(a)(1), (b). 
Additionally, under Sec.  405.1012(a)(2), an ALJ may request, but may 
not require, CMS and/or one or more of its contractors to be a party to 
a hearing and cannot draw any adverse inferences if CMS or the 
contractor decides not to be a party to the hearing. Our proposal does 
not undermine QIC accountability, as current Sec.  405.1012 already 
provides flexibility for CMS or any CMS contractor, not just the QIC, 
to elect to join an appeal as a party, with the limitation that only 
the first entity to file its election after the notice of hearing is 
issued may attend the oral hearing. Our proposal to permit the 
designation of a contractor, other than the QIC, to perform the 
administrative role of disseminating hearing requests, would not change 
the ability of CMS or any of its contractors to elect to be a party to 
an OMHA appeal.
    As for the commenter's concern about the current time frame for CMS 
or CMS contractor submission of position papers or written testimony 
when a hearing is scheduled, this comment is beyond the scope of the 
proposed rule, and we will not be addressing it in this final rule.
    Finally, we thank the commenter for alerting us to the 
typographical error we inadvertently made in the preamble to the 
proposed rule by referring to Sec.  405.1012(b)(2) instead of Sec.  
405.1012(b) in one place in the discussion. The proposed regulation 
text of the proposed rule (83 FR 49526) correctly reflected our 
proposal to modify Sec.  405.1012(b).
    After review and consideration of the comments received, and for 
the reasons discussed previously and in the proposed rule, we are 
finalizing these proposed changes without modification to Sec. Sec.  
405.1010(b)(1), (b)(3)(ii), (c)(3)(i), and (c)(3)(ii)(A) and 
405.1012(a)(1), (b), and (e)(1).
c. 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

[[Page 19864]]

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 asks the appellant to 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 proposed 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 (83 FR 
49520, 49521, and 49526). We also proposed a corresponding revision to 
Sec.  423.2014(e)(3) for extension requests filed by Medicare Part D 
enrollees (83 FR 49520, 49521, and 49528).
    We received no comments on this proposal. Accordingly, for the 
reasons discussed previously and in the proposed rule, we are 
finalizing the proposed revisions without modification to Sec. Sec.  
405.1014 and 423.2014.
d. 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 proposed 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 (83 FR 
49521 and 49526). As discussed in section II.H.2. of the proposed rule 
with regard to CMS and CMS contractor submissions, we proposed, and are 
finalizing a change to the regulation, 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. We noted that 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 (83 FR 49521).
    We received a comment on this proposal, which we have summarized 
and addressed as follows.
    Comment: A commenter opposed the proposal to allow CMS to designate 
another contractor, other than the QIC, to receive notices of hearing, 
because the contractor that rendered the decision appealed should be a 
party to the hearing, not a third party that was not previously 
involved in the appeal. The commenter expressed concern that last 
minute designations by CMS would unfairly prejudice providers.
    Response: We do not agree with the commenter that our proposal to 
allow flexibility for CMS to designate another contractor to receive 
notices of hearing will unfairly prejudice providers. As clarified in 
an earlier response, the contractor designated to receive notices of 
hearing will not replace the QIC that issued the reconsideration as a 
potential party to the hearing, or prevent the QIC from participating 
in an appeal. Under current Sec. Sec.  405.1010 and 405.1012, CMS or 
any of its contractors may elect to participate in the proceedings on a 
request for an ALJ hearing, and one of these entities may also elect to 
be a party to the proceedings if a hearing is scheduled and the 
appellant is not an unrepresented beneficiary. The CMS-designated 
recipient of the notice of hearing under proposed Sec.  405.1020(c)(1), 
whether it continues to be the QIC that issued the reconsideration or 
another contractor that CMS designates to receive the notice of 
hearing, will disseminate the notice of hearing to any other CMS 
contractor involved in reviewing the claim at issue or an appeal 
thereof. The proposal, which we are finalizing, merely provides CMS 
with flexibility to designate a different contractor to receive notices 
of hearing on CMS's behalf and disseminate notice of the hearing to the 
QIC and other CMS contractors.
    For the reasons discussed previously and in the proposed rule, we 
are finalizing this proposed change without modification to Sec.  
405.1020(c)(1).
e. Request for an In-Person or Video Teleconference (VTC) Hearing 
(Sec. Sec.  405.1020 and 423.2020)
    Section 405.1020(i)(1) and (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 (82 FR 5046), 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.
    As we discussed in the proposed rule (83 FR 49521), 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

[[Page 19865]]

an ALJ's offer to conduct a hearing by telephone and requests a VTC 
hearing. Accordingly, we proposed 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 proposed 
corresponding revisions to Sec.  423.2020(i)(5) for objections filed by 
Medicare Part D enrollees.
    As further discussed in the proposed rule, 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 proposed 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 (83 FR 49521 through 49526). We 
also proposed a corresponding revision to Sec.  423.2020(e) concerning 
a Medicare Part D enrollee's objection to the time and place of hearing 
(83 FR 49528).
    We received no comments on this proposal. Accordingly, for the 
reasons discussed previously and in the proposed rule, we are 
finalizing the revision proposed previously without modification.
f. 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), (a)(4)(i), and 
(a)(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 the proposed rule, we proposed 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.
    As discussed 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 proposed 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 (83 FR 49526). We also proposed corresponding corrections 
to Sec.  423.2052(a)(3), (5), and (6) for dismissals of Part D requests 
for hearing (83 FR 49529).
    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 that 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, as we discussed in the proposed rule (83 FR 49522), 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 
proposed 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 
(83 FR 49526). We stated that 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 (83 FR 49522).
    We received no comments on the proposals described previously.
    Accordingly, for the reasons discussed previously and in the 
proposed rule, we are finalizing the revisions proposed previously 
without modification.

[[Page 19866]]

g. 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.
    As we stated in the proposed rule (83 FR 49522), 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. We explained that, 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 proposed 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 (83 FR 48527). 
We also proposed 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 (83 FR 49529). We stated that 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.  405.1056(d) or Sec.  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 proposed 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) (83 FR 49522, 49527, and 49529).
    Second, we proposed 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 (83 FR 49522 and 49526).
    We received a comment on this proposal. Following is a summary of 
the comment we received and our response to this comment.
    Comment: One commenter opposed the proposal to revise Sec. Sec.  
405.1056(d) and 423.2056(d) to allow an ALJ or attorney adjudicator to 
remand a request for review of a dismissal if an official copy of the 
notice of dismissal or case file cannot be obtained from the QIC 
because the commenter believed it would reduce CMS contractors' 
accountability for recordkeeping and timely transmission of case file 
information, while creating additional burden and delays for 
appellants. The commenter further stated that the proposal to revise 
Sec. Sec.  405.1056(d) and 423.2056(d) to allow an ALJ or attorney 
adjudicator to remand decisions if an official copy of the case file 
cannot be obtained would have the effect of increasing, not decreasing, 
the number of pending appeals, and that ``if CMS or its contractors 
cannot maintain appropriate records, then an adverse finding should be 
reversed.''
    Response: We do not agree with the commenter that our proposal to 
revise Sec. Sec.  405.1056(d) and 423.2056(d) to permit an OMHA 
adjudicator to remand a request for review of a dismissal when OMHA is 
unable to obtain the case file or an official copy of a notice of 
dismissal would reduce CMS contractor accountability, create additional 
burden or cause undue delays for appellants, or significantly add to 
the number of pending appeals. OMHA and CMS have joint operating 
procedures in place for transmitting case files. Currently, in the rare 
circumstance in which the QIC or IRE does not respond to a request for 
a case file, OMHA sends a second request. Requests for hearing are 
remanded only if the QIC or IRE does not respond to the second request, 
or does respond but is unable to furnish the requested case file. 
Similarly, when an official copy of a redetermination or 
reconsideration is missing from the case file, Sec. Sec.  
405.1034(a)(1) and 423.2034(a)(1) require that OMHA verify whether an 
electronic copy of the redetermination or reconsideration is available 
in the official system of record, and if so accept the electronic copy 
as an official copy. If an electronic copy is not available in the 
system of record, an OMHA adjudicator is required to request the 
missing information from the QIC or IRE, or its successor, while 
retaining jurisdiction over the case. Then, only if the QIC or IRE does 
not furnish the requested redetermination or reconsideration within the 
time frame specified in Sec.  405.1034 or Sec.  423.2034 is a remand 
authorized under Sec.  405.1056(a)(1) or Sec.  423.2056(a)(1).
    In proposed Sec. Sec.  405.1056(d) and 423.2056(d), authorizing 
remands when an official copy of the notice of dismissal or a case file 
for an appealed dismissal of a request for reconsideration cannot be 
obtained from the QIC or IRE, OMHA would apply the same procedures that 
currently apply under Sec. Sec.  405.1034(a) and 423.2034(a) for 
missing redeterminations, reconsiderations, and case files for appealed 
reconsiderations and the same joint operating procedures that are 
already in place for requesting case files. We further proposed to 
revise Sec. Sec.  405.1034(a)(1) and 423.2034(a)(1) to require that 
OMHA first confirm whether an official copy of a missing notice of 
dismissal is available in the official system of record before issuing 
a request for information to the QIC or IRE (83 FR 49526 and 49528). 
Thus, the same safeguards that currently apply to prevent unnecessary 
requests for information and remands in appeals of reconsiderations 
would also apply to requests for review of a dismissal, and would help 
ensure appellants are not subjected to increased burdens or delays that 
may be associated with a remand. Rather than reducing accountability, 
we

[[Page 19867]]

believe the possibility that a case may be remanded would increase 
accountability and encourage the QIC or IRE to furnish complete case 
files for requests for review of a dismissal upon receipt of the 
initial OMHA case file request.
    In the rare circumstances where a missing dismissal or case file 
could not be obtained by OMHA because the QIC or IRE does not respond 
to OMHA's case file request, or because an electronic copy of the 
missing notice of dismissal is not available in the official system of 
record and the QIC or IRE does not respond to OMHA's request under 
Sec.  405.1034(a) or Sec.  423.2034(a), or because the QIC or IRE 
cannot locate the requested case file or dismissal, we believe a remand 
to the QIC or IRE that issued the dismissal would be the most efficient 
means to reconstruct the record or, if necessary, re-adjudicate the 
request for reconsideration. The commenter's suggestion that OMHA issue 
a fully favorable determination and reverse the denial is not 
appropriate, as it would require CMS or a plan to pay previously denied 
claims or authorize previously denied requests for coverage without 
regard to their merits. HHS is charged with maintaining Medicare 
program integrity against waste, fraud, and abuse, and has a statutory 
obligation to ensure that non-meritorious claims that do not meet 
statutory criteria for payment are not paid (see, for example, sections 
1814, 1835, 1862(a), and 1893 of the Act).
    After review and consideration of the comments received, for the 
reasons discussed previously and in the proposed rule, we are 
finalizing these proposed changes without modification to Sec. Sec.  
405.1034(a)(1), 405.1056(d) and (g), 423.2034(a)(1), and 423.2056(d) 
and (g).
h. 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, as discussed in the proposed rule (83 FR 
49522), 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 previously with 
regard to notices of dismissal, we proposed 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 to the hearing (83 FR 49522, 49523, and 
49527). We stated that 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 the proposed rule, we proposed 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 proposed 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) (83 FR 49527). We also 
proposed corresponding changes to Sec.  423.2056(f) (83 FR 49529).
    We received no comments on the proposals described previously. 
Accordingly, for the reasons discussed previously and in the proposed 
rule, we are finalizing the proposed revisions without modification to 
Sec. Sec.  405.1056(f) and 423.2056(f).
i. 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, as discussed in the proposed rule (83 FR 
49523), 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. We stated that, 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 proposed 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 (83 
FR 49529).
    We received no comments on this proposal. Accordingly, for the 
reasons discussed previously and in the proposed rule, we are 
finalizing the proposed revision without modification to Sec.  
423.2056(b).
j. 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, as 
discussed in the proposed rule (83 FR 49523), 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 
proposed 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 (83 FR 
49525).
    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 stated in the proposed rule (83 FR 49523) that we neglected 
to change one reference to ``MAC'' in Sec.  423.1990(d)(2)(ii). 
Accordingly, we proposed to revise Sec.  423.1990(d)(2)(ii) by 
replacing ``MAC'' with ``Council'' (83 FR 49527).
    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

[[Page 19868]]

calling witnesses or cross-examining the witnesses of an enrollee to 
the hearing. As discussed in the proposed rule (83 FR 49523), 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. We stated in the proposed rule (83 FR 49523) that, 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 stated that we believe 
this phrase is unnecessary in this context and reads awkwardly, and 
proposed to revise Sec.  423.2010(d)(1) to remove it (83 FR 49523 and 
49528).
    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, as we stated in the proposed rule (83 FR 49523), 
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 proposed to revise 
Sec.  423.2016(b)(1) by replacing ``hearing'' with ``decision'' (83 FR 
49528).
    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.'' As we discussed in the proposed 
rule, we inadvertently omitted the word ``a'' and proposed to revise 
Sec.  423.2032(c) by removing the phrase ``to pending appeal'' and 
adding ``to a pending appeal'' in its place (83 FR 49523 and 49528).
    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.'' As discussed in the 
proposed rule (83 FR 49523), in the January 17, 2017 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 proposed to revise Sec.  423.2036(d) by adding 
``, to do so'' at the end of the paragraph, before the period (83 FR 
49529).
    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. As discussed in the 
proposed rule (83 FR 49523), in the January 17, 2017 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 proposed to 
revise Sec.  423.2036(e) to replace the reference to ``Sec.  
423.2034(b)(2)'' with the reference ``Sec.  423.2056(e)'' (83 FR 
49529).
    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 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 proposed to 
replace the phrase ``limitation of liability'' with ``limitation on 
liability'' in each of these sections (83 FR 49525 through 49527).
    As we stated in the proposed rule (83 FR 49524), we 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 proposed 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 (83 FR 49526 through 49528).
    Lastly, we proposed to revise the authority citations for parts 405 
and 423 to meet the current Office of the Federal Register regulatory 
drafting guidance (83 FR 49524, 49525, and 49527). As we stated in the 
proposed rule (83 FR 49524), the guidance requires that we use only the 
United States Code (U.S.C.) citations for statutory citations unless 
the citation does not exist.
    We received no comments on the proposed technical changes discussed 
previously. Accordingly, for the reasons discussed previously and in 
the proposed rule, we are finalizing the revisions proposed previously 
without modification.

III. Collection of Information Requirements

    This final rule revises the appeals process regarding claims for 
benefits under Medicare Parts A and B and for Medicare prescription 
drug coverage determinations under Part D. Since appeals are 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)). The burden for preparing and filing an 
appeal is exempt from the requirements of the Paperwork Reduction Act 
of 1995 (PRA, 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

[[Page 19869]]

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 final 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 604 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 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 2019, that 
threshold is approximately $154 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 
``EO 13771 deregulatory actions are not limited to those defined as 
significant under EO 12866 or OMB's Final Bulletin on Good Guidance 
Practices.'' This final rule, is considered an E.O. 13771 deregulatory 
action. Consistent with Executive Order 13771 requirements, when 
discounted from 2016 to infinity at 7 percent, this final rule would 
annually save $9,497,685.00 a year.
    The final policy 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 
administrative time spent would be 284,486 x .083 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.
    We did not receive comments on the burden estimates outlined in the 
proposed rule.
    In accordance with the provisions of Executive Order 12866, this 
rule was reviewed by the Office of Management and Budget.

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 the reasons set forth in the preamble, the Centers for Medicare 
& Medicaid Services amends 42 CFR chapter IV as set forth below:

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''.

[[Page 19870]]

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 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--
0
a. Revising paragraph (c)(1);
0
b. Adding paragraph (e)(5); and
0
c. Revising paragraph (i)(5).
    The revisions and addition 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:

[[Page 19871]]

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.
    (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;
0
b. In paragraph (b)(2) by removing the term ``issued'' and adding the 
term ``received'' in its place; and
0
c. Adding paragraph (e).
    The addition reads as follows:


Sec.  405.1110  Council reviews 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.

[[Page 19872]]

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 reference ``Sec.  423.2006'' in its place.


Sec.  423.576   [Amended]

0
23. Section 423.576 is amended by removing the references ``Sec.  
423.580 through Sec.  423.604'' and ``Sec.  423.1970 through Sec.  
423.1976'' and adding the references ``Sec. Sec.  423.580 through 
423.604'' and ``Sec. Sec.  423.2000 through 423.2140'' in their places, 
respectively.


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 reference ``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 Sec.  423.2000 through Sec.  423.2063'' and adding 
the reference ``Sec. Sec.  423.2000 through 423.2063'' in its place; 
and
0
b. In paragraph (d) by removing the reference ``Sec.  423.1974 and 
Sec.  423.2100 through Sec.  423.2130'' and adding the reference 
``Sec. Sec.  423.2100 through 423.2130'' in its place.


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) The enrollee meets the amount in controversy requirements of 
Sec.  423.2006.
    (b) * * *
    (3) The 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 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

[[Page 19873]]

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--
0
a. Revising paragraph (a);
0
b. Adding paragraph (e)(5); and
0
c. Revising paragraph (i)(5).
    The revisions and addition 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.
* * * * *


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 ``The ALJ or attorney 
adjudicator dismisses'' and adding the phrase ``The ALJ dismisses'' in 
its place;
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

[[Page 19874]]

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 (g) 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;
0
b. In paragraph (b)(2) introductory text by removing the term 
``issued'' and adding the term ``received'' in its place; and
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: March 19, 2019.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
    Dated: April 2, 2019.

Alex M. Azar II,
Secretary, Department of Health and Human Services.
[FR Doc. 2019-09114 Filed 5-3-19; 11:15 am]
 BILLING CODE 4120-01-P