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

Cited as:84 FR 19855
Court:Centers For Medicare & Medicaid Services
Publication Date:07 May 2019
Record Number:2019-09114
Federal Register, Volume 84 Issue 88 (Tuesday, May 7, 2019)
[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