[Federal Register Volume 81, Number 128 (Tuesday, July 5, 2016)]
[Proposed Rules]
[Pages 43790-43891]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-15192]



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Vol. 81

Tuesday,

No. 128

July 5, 2016

Part III





Department of Health and Human Services





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Centers for Medicare & Medicaid Services





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42 CFR Parts 401, 405, 422, et al.





Medicare Program: Changes to the Medicare Claims and Entitlement, 
Medicare Advantage Organization Determination, and Medicare 
Prescription Drug Coverage Determination Appeals Procedures; Proposed 
Rule

  Federal Register / Vol. 81 , No. 128 / Tuesday, July 5, 2016 / 
Proposed Rules  

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 401, 405, 422, 423, and 478

[HHS-2015-49]
RIN 0991-AC02


Medicare Program: Changes to the Medicare Claims and Entitlement, 
Medicare Advantage Organization Determination, and Medicare 
Prescription Drug Coverage Determination Appeals Procedures

AGENCY: Centers for Medicare & Medicaid Services, HHS.

ACTION: Proposed rule.

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SUMMARY: This proposed rule would revise the procedures that the 
Department of Health and Human Services would follow at the 
Administrative Law Judge level for appeals of payment and coverage 
determinations for items and services furnished to Medicare 
beneficiaries, enrollees in Medicare Advantage and other Medicare 
competitive health plans, and enrollees in Medicare prescription drug 
plans, as well as appeals of Medicare beneficiary enrollment and 
entitlement determinations, and certain Medicare premium appeals. In 
addition, this proposed rule would revise procedures that the 
Department of Health and Human Services would follow at the Centers for 
Medicare & Medicaid Services (CMS) and the Medicare Appeals Council 
(Council) levels of appeal for certain matters affecting the 
Administrative Law Judge level.

DATES: To be assured consideration, comments must be received at one of 
the addresses provided below, no later than 5 p.m. eastern standard 
time (e.s.t.) on August 29, 2016.

ADDRESSES: In commenting, refer to ``HHS-2015-49'' at the top of your 
comments. Because of staff and resource limitations, we cannot accept 
comments by facsimile (FAX) transmission. We will not accept comments 
submitted after the comment period.
    You may submit comments in one of two ways (to ensure that we do 
not receive duplicate copies, please choose only one of the ways 
listed):
    1. Electronically. You may submit electronic comments on this 
proposed rule at www.regulations.gov. For new users, you can find 
instructions on how to find a proposed rule and submit comments under 
the ``Help'' tab at www.regulations.gov.
    If you are submitting comments electronically, we strongly 
encourage you to submit any comments or attachments in Microsoft Word 
format. If you must submit a comment in Portable Document Format (PDF), 
we strongly encourage you to convert the PDF to print-to-PDF format or 
to use some other commonly used searchable text format. Please do not 
submit the PDF in a scanned or read-only format. Using a print-to-PDF 
format allows us to electronically search and copy certain portions of 
your submissions.
    2. U.S. Mail or commercial delivery. You may send written comments 
to the following address ONLY: Office of Medicare Hearings and Appeals, 
Department of Health and Human Services, Attention: HHS-2015-49, 5201 
Leesburg Pike, Suite 1300, Falls Church, VA 22041.
    Please allow sufficient time for mailed comments to be received 
before the close of the comment period.
    Privacy Note: Because comments will be made available for public 
viewing in their entirety on the Federal eRulemaking portal, commenters 
should exercise caution and only include in their comments information 
that they wish to make publicly available.
    For information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: 
    Rita Wurm, (410) 786-1139 (for issues related to CMS appeals 
policies and reopening policies).
    Jason Green, (571) 777-2723 (for issues related to Administrative 
Law Judge appeals policies).
    Debbie Nobleman, (202) 565-0139 (for issues related to Council 
appeals policies).

SUPPLEMENTARY INFORMATION: 
    Inspection of Public Comments: All comments received before the 
close of the comment period are available for viewing by the public, 
including any personally identifiable or confidential business 
information that is included in a comment. We will post all comments 
received before the close of the comment period on the following Web 
site as soon as possible after they have been received: 
www.regulations.gov. Follow the search instructions on that Web site to 
view public comments.
    Comments received timely will also be available for public 
inspection as they are received, generally beginning approximately 4 
weeks after publication of a document, at the headquarters of the 
Office of Medicare Hearings and Appeals, 1700 North Moore Street, Suite 
1650, Arlington, Virginia 22209, Monday through Friday of each week 
from 8:30 a.m. to 4:00 p.m. To schedule an appointment to view public 
comments, phone (703) 235-0635.

Abbreviations

    Because we refer to a number of terms by abbreviation or a 
shortened form in this proposed rule, we are listing these 
abbreviations and shortened forms, and their corresponding terms in 
alphabetical order below:

Act--Social Security Act
ALJ--Administrative Law Judge
APA--Administrative Procedures Act
BIPA--Medicare, Medicaid, and SCHIP Benefits Improvement and 
Protection Act of 2000 (Pub. L. 106-554)
CMS--Centers for Medicare & Medicaid Services
Council--Medicare Appeals Council
DAB--Departmental Appeals Board
HHS--U.S. Department of Health and Human Services
IRE--Independent Review Entity
IRMAA--Income Related Monthly Adjustment Amount
MA--Medicare Advantage
MAO--Medicare Advantage Organization
MMA--Medicare Prescription Drug, Improvement, and Modernization Act 
of 2003 (Pub. L. 108-173)
OIG--HHS Office of Inspector General
OMHA--Office of Medicare Hearings and Appeals
QIC--Qualified Independent Contractor
QIO--Quality Improvement Organization
SSA--Social Security Administration

Section 1557 of the Affordable Care Act

    Independent of the standards proposed in this rule, the Department 
commits to complying with section 1557 of the Affordable Care Act, 
Public Law 111-148, 124 Stat. 470 (42 U.S.C. 18116), which prohibits 
discrimination on the basis of race, color, national origin, sex, age, 
or disability in certain health programs and activities. HHS issued a 
proposed rule to implement section 1557, Nondiscrimination in Health 
Programs and Activities, on September 8, 2015. 80 FR 54172. The 
proposed rule would apply, in part, to health programs and activities 
administered by the Department.

Table of Contents

I. Background
II. General Provisions of the Proposed Regulations
    A. Precedential Final Decisions of the Secretary
    B. Attorney Adjudicators
    C. Application of 405 Rules to Other Parts
    D. OMHA References
    E. Medicare Appeals Council References
III. Specific Provisions of the Proposed Rule
    A. Provisions of Part 405, subpart I and Part 423, subparts M 
and U
    1. Overview

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    2. General provisions, reconsiderations, reopenings, and 
expedited access to judicial review
    a. Part 423, subpart M general provisions (Sec.  423.562)
    b. Part 423, subpart U title and scope (Sec.  423.1968)
    c. Medicare initial determinations, redeterminations and appeals 
general description (Sec.  405.904)
    d. Parties to the initial determinations, redeterminations, 
reconsiderations proceedings on a request for hearing, and Council 
review (Sec.  405.906)
    e. Medicaid State agencies (Sec.  405.908)
    f. Appointed representatives (Sec.  405.910)
    g. Actions that are not initial determinations (Sec.  405.926)
    h. Notice of a redetermination (Sec.  405.956)
    i. Time frame for making a reconsideration following a 
contractor redetermination, withdrawal or dismissal of a request for 
a reconsideration, and reconsideration (Sec. Sec.  405.970, 405.972, 
and 405.974)
    j. Notice of reconsideration (Sec.  405.976)
    k. Effect of a reconsideration (Sec.  405.978)
    l. Reopenings (Sec. Sec.  405.980, 405.982, 405.984, 423.1978, 
423.1980, 423.1982, and 423.1984)
    m. Expedited access to judicial review (Sec. Sec.  405.990 and 
423.1990)
    3. ALJ hearings
    a. Hearing before an ALJ and decision by an ALJ and attorney 
adjudicator: General rule (Sec. Sec.  405.1000 and 423.2000)
    b. Right to an ALJ hearing (Sec. Sec.  405.1002 and 423.2002)
    c. Right to a review of QIC or IRE notice of dismissal 
(Sec. Sec.  405.1004 and 423.2004)
    d. Amount in controversy required for an ALJ hearing (Sec. Sec.  
405.1006 and 423.1970)
    e. Parties to an ALJ hearing (Sec. Sec.  405.1008 and 423.2008)
    f. CMS and CMS contractors as participants or parties in the 
adjudication process (Sec. Sec.  405.1010, 405.1012, and 423.2010)
    i. Section 405.1010: When CMS or its contractors may participate 
in the proceedings on a request for an ALJ hearing
    ii. Section 423.2010: When CMS, the IRE, or Part D plan sponsors 
may participate in the proceedings on a request for an ALJ hearing
    iii. Section 405.1012: When CMS or its contractors may be a 
party to a hearing
    g. Request for an ALJ hearing or review of a QIC or an IRE 
dismissal (Sec. Sec.  405.1014, 423.1972 and 423.2014)
    i. Requirements for a request for hearing or review of a QIC or 
an IRE dismissal
    ii. Requests for hearing involving statistical sampling and 
extrapolations
    iii. Opportunity to cure defective filings
    iv. Where and when to file a request for hearing or review of a 
QIC or an IRE dismissal
    v. Sending copies of a request for hearing and other evidence to 
other parties to the appeal
    vi. Extending time to file a request for hearing or review of a 
QIC or an IRE dismissal
    h. Time frames for deciding an appeal of a QIC or an IRE 
reconsideration or an escalated request for a QIC reconsideration, 
and request for Council review when an ALJ does not issue a decision 
timely (Sec. Sec.  405.1016, 405.1104 and 423.2016)
    i. Section 405.1016: Time frames for deciding an appeal of a QIC 
or an escalated request for a QIC reconsideration
    ii. Section 405.1104: Request for Council review when an ALJ 
does not issue a decision timely
    iii. Section 423.2016: Time frames for deciding an appeal of an 
IRE reconsideration
    i. Submitting evidence (Sec. Sec.  405.1018 and 423.2018)
    j. Time and place for a hearing before an ALJ (Sec. Sec.  
405.1020 and 423.2020)
    k. Notice of a hearing before an ALJ and objections to the 
issues (Sec. Sec.  405.1022, 405.1024, 423.2022, and 423.2024)
    l. Disqualification of the ALJ or attorney adjudicator 
(Sec. Sec.  405.1026 and 423.2026)
    m. Review of evidence submitted by the parties (Sec.  405.1028)
    n. ALJ hearing procedures (Sec. Sec.  405.1030 and 423.2030)
    o. Issues before an ALJ or attorney adjudicator (Sec. Sec.  
405.1032, 405.1064 and 423.2032)
    p. Requesting information from the QIC or IRE, and remanding an 
appeal (Sec. Sec.  405.1034, 405.1056, 405.1058, 423.2034, 423.2056, 
and 423.2058)
    q. Description of the ALJ hearing process and discovery 
(Sec. Sec.  405.1036, 405.1037, and 423.2036)
    r. Deciding a case without a hearing before an ALJ (Sec. Sec.  
405.1038 and 423.2038)
    s. Prehearing and posthearing conferences (Sec. Sec.  405.1040 
and 423.2040)
    t. The administrative record (Sec. Sec.  405.1042 and 423.2042)
    u. Consolidated proceedings (Sec. Sec.  405.1044 and 423.2044)
    v. Notice of decision and effect of an ALJ's or attorney 
adjudicator's decision (Sec. Sec.  405.1046, 405.1048, 423.2046, and 
423.2048)
    w. Removal of a hearing request from an ALJ to the Council 
(Sec. Sec.  405.1050 and 423.2050)
    x. Dismissal of a request for hearing or request for review and 
effect of a dismissal of a request for hearing or request for review 
(Sec. Sec.  405.1052, 405.1054, 423.2052 and 423.2054)
    4. Applicability of Medicare coverage policies (Sec. Sec.  
405.1060, 405.1062, 405.1063, 423.2062, and 423.2063)
    5. Council review and judicial review
    a. Council review: general (Sec. Sec.  405.1100, 423.1974 and 
423.2100)
    b. Request for Council review when ALJ issues decision or 
dismissal (Sec. Sec.  405.1102 and 423.2102)
    c. Where a request for review or escalation may be filed 
(Sec. Sec.  405.1106 and 423.2106)
    d. Council actions when request for review or escalation is 
filed (Sec. Sec.  405.1108 and 423.2108)
    e. Council reviews on its own motion (Sec. Sec.  405.1110 and 
423.2110).
    f. Content of request for review (Sec. Sec.  405.1112 and 
423.2112).
    g. Dismissal of request for review (Sec. Sec.  405.1114 and 
423.2114)
    h. Effect of dismissal of request for Council review or request 
for hearing (Sec. Sec.  405.1116 and 423.2116)
    i. Obtaining evidence from the Council (Sec. Sec.  405.1118 and 
423.2118)
    j. What evidence may be submitted to the Council (Sec. Sec.  
405.1122 and 423.2122)
    k. Case remanded by the Council (Sec. Sec.  405.1126 and 
423.2126)
    l. Action of the Council (Sec. Sec.  405.1128 and 423.2128)
    m. Request for escalation to Federal court (Sec.  405.1132)
    n. Judicial review (Sec. Sec.  405.1136, 423.1976, and 423.2136)
    o. Case remanded by a Federal court (Sec. Sec.  405.1038 and 
423.2138)
    p. Council review of ALJ decision in a case remanded by a 
Federal district court (Sec. Sec.  405.1140 and 423.2140)
    B. Part 405, subpart J expedited reconsiderations (Sec.  
405.1204)
    C. Part 422, subpart M
    1. General provisions (Sec.  422.562).
    2. Notice of reconsidered determination by the independent 
entity (Sec.  422.594).
    3. Request for an ALJ hearing (Sec.  422.602).
    4. Medicare Appeals Council (Council) review (Sec.  422.608).
    5. Judicial review (Sec.  422.612)
    6. Reopening and revising determinations and decisions (Sec.  
422.616)
    7. How an MA organization must effectuate standard 
reconsideration determinations and decisions, and expedited 
reconsidered determinations (Sec. Sec.  422.618 and 422.619)
    8. Requesting immediate QIO review of the decision to discharge 
from the inpatient hospital and fast-track appeals of service 
terminations to independent review entities (IREs) (Sec. Sec.  
422.622 and 422.626).
    D. Part 478, subpart B
    1. Applicability and beneficiary's right to a hearing 
(Sec. Sec.  478.14 and 478.40)
    2. Submitting a request for a hearing (Sec.  478.42)
    3. Determining the amount in controversy (Sec.  478.44)
    4. Medicare Appeals Council and judicial review (Sec.  478.46)
    5. Reopening and revision of a reconsidered determination or a 
decision (Sec.  478.48)
IV. Collection of Information Requirements
V. Response to Comments
VI. Regulatory Impact Statement
VII. Federal Analysis

I. Background

    In accordance with provisions of sections 1155, 1852, 1860D-4, 
1869, and 1876 of the Act, and their implementing regulations, there 
are multiple administrative appeal processes for Medicare fee-for-
service (Part A and Part B) claim, entitlement and certain premium 
initial determinations; Medicare Advantage (Part C) and other 
competitive health plan organization determinations; and Part D plan 
sponsor coverage determinations and certain premium determinations. The 
first, and in many instances a second, level of administrative appeal 
are administered

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by Medicare contractors, Part D plan sponsors, Medicare Advantage 
organizations or Medicare plans, or by the SSA. For example, under 
section 1869 of the Act, the Medicare claims appeal process involves 
redeterminations conducted by the Medicare Administrative Contractors 
(which are independent of the staff that made the initial 
determination) followed by reconsiderations conducted by QICs. However, 
all of the appeals discussed in this proposed regulation could be 
appealed to the ALJs at OMHA if the amount in controversy requirement 
and other requirements are met after these first and/or second levels 
of appeal.
    OMHA, a staff division within the Office of the Secretary of HHS, 
administers the nationwide ALJ hearing program for Medicare claim, 
organization and coverage determination, and entitlement and certain 
premium appeals. If the amount in controversy and other filing 
requirements are met, a hearing before an ALJ is available following a 
QIO reconsidered determination under section 1155 of the Act; an SSA or 
QIC reconsideration, or a request for QIC reconsideration for which a 
decision is not issued timely and a party requests escalation of the 
matter under section 1869(b)(1)(A) and (d) of the Act (Part A and Part 
B appeals); an IRE reconsideration or QIO reconsidered determination 
under sections 1876(c)(5)(B) or 1852(g)(5) of the Act (Part C and other 
managed health plan appeals); or an IRE reconsideration under section 
1860D-4(h) of the Act (Part D appeals). In addition, under current 
regulations a review by an ALJ is available following a dismissal of a 
request for reconsideration, if the amount in controversy and other 
filing requirements are met.
    OMHA provides Medicare beneficiaries and the providers and 
suppliers that furnish items or services to Medicare beneficiaries, as 
well as applicable plans, MAOs, and Medicaid State agencies with a fair 
and impartial forum to address disagreements regarding: Medicare 
coverage and payment determinations made by Medicare contractors, MAOs, 
or Part D plan sponsors; and determinations related to Medicare 
beneficiary eligibility and entitlement, Part B late enrollment 
penalties, and IRMAAs, which apply to Medicare Part B and Part D 
premiums, made by SSA. Further review of OMHA ALJ decisions, except 
decisions affirming a dismissal of a request for reconsideration, is 
available from the Medicare Appeals Council (Council) within the DAB, a 
staff division within the Office of the Secretary of HHS. Judicial 
review is then available for Council decisions in Federal courts, if 
the amount in controversy and other requirements are met.
    OMHA ALJs began adjudicating appeals in July 2005, based on section 
931 of the MMA, which required the transfer of responsibility for the 
ALJ hearing level of the Medicare claim and entitlement appeals process 
from SSA to HHS. New rules at 42 CFR part 405, subpart I and subpart J 
were also established to implement statutory changes to the Medicare 
fee-for-service (Part A and Part B) appeals process made by BIPA in 
2000 and the MMA in 2003. Among other things, these new rules addressed 
appeals of reconsiderations made by QICs, which were created by BIPA 
for the Part A and Part B programs. These rules also apply to appeals 
of SSA reconsiderations. The statutory changes made by BIPA included a 
90-day adjudication time frame for ALJs to adjudicate appeals of QIC 
reconsiderations beginning on the date that a request for an ALJ 
hearing is timely filed. The new part 405, subpart I rules were 
initially proposed in the November 15, 2002 Federal Register (67 FR 
69312) (2002 Proposed Rule) to implement BIPA, and were subsequently 
implemented in an interim final rule with comment period, which also 
set forth new provisions to implement the MMA, in the March 8, 2005 
Federal Register (70 FR 11420) (2005 Interim Final Rule). Correcting 
amendments to the 2005 Interim Final Rule were published in the June 
30, 2005 Federal Register (70 FR 37700) (2005 Correcting Amendment I) 
and in the August 26, 2005 Federal Register (70 FR 50214) (2005 
Correcting Amendment II), and the final rule was published in the 
December 9, 2009 Federal Register (74 FR 65296) (2009 Final Rule). 
Subsequent revisions to part 405, subpart I to implement the 
Strengthening Medicare and Repaying Taxpayers Act of 2012 (SMART Act, 
Pub. L. 112-242) were published in the February 27, 2015 Federal 
Register (80 FR 10611) (SMART Act Final Rule).
    In addition to the part 405, subpart I rules, OMHA applies the 
rules at 42 CFR part 478, subpart B to individuals' appeals of QIO 
reconsidered determinations; part 422, subpart M to appeals of IRE 
reconsiderations or QIO reconsidered determinations under the Medicare 
Advantage (Part C) and other competitive health plan programs; and part 
423, subpart U to appeals of IRE reconsiderations under the Medicare 
prescription drug (Part D) program.
    In recent years, the Medicare appeals process has experienced an 
unprecedented and sustained increase in the number of appeals. At OMHA, 
for example, the number of requests for an ALJ hearing or review 
increased 1,222 percent, from fiscal year (FY) 2009 through FY 2014. 
The increasing number of requests has strained OMHA's available 
resources and resulted in delays for appellants to obtain hearings and 
decisions.
    Despite significant gains in OMHA ALJ productivity (in FY 2014, 
each OMHA ALJ issued, on average, a record 1,048 decisions and an 
additional 456 dismissals), and CMS and OMHA initiatives to address the 
increasing number of appeals, the number of requests for an ALJ hearing 
and requests for reviews of QIC and IRE dismissals continue to exceed 
OMHA's capacity to adjudicate the requests. As of April 30, 2016, OMHA 
had over 750,000 pending appeals, while OMHA's adjudication capacity 
was 77,000 appeals per year, with an additional adjudication capacity 
of 15,000 appeals per year expected by the end of Fiscal Year 2016.
    HHS has a three-prong approach to addressing the increasing number 
of appeals and the current backlog of claims waiting to be adjudicated 
at OMHA: (1) Request new resources to invest at all levels of appeal to 
increase adjudication capacity and implement new strategies to 
alleviate the current backlog; (2) take administrative actions to 
reduce the number of pending appeals and implement new strategies to 
alleviate the current backlog ; and (3) propose legislative reforms 
that provide additional funding and new authorities to address the 
volume of appeals. In this notice of proposed rulemaking, HHS is 
pursuing the three-prong approach by proposing rules that would expand 
the pool of available OMHA adjudicators and improve the efficiency of 
the appeals process by streamlining the processes so less time is spent 
by adjudicators and parties on repetitive issues and procedural 
matters.

II. General Provisions of the Proposed Regulations

A. Precedential Final Decisions of the Secretary

    Council decisions are binding on the parties to that particular 
appeal and are the final decisions of the Secretary from which judicial 
review may be sought under section 205(g) of the Act, in accordance 
with current Sec. Sec.  405.1130, 422.612(b), 423.2130, and 478.46(b). 
As explained in the 2009 Final Rule (74 FR 65307 through 65308), 
``binding'' indicates the parties are obligated to

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abide by the adjudicator's action or decision unless further recourse 
is available and a party exercises that right. ``Final'' indicates that 
no further administrative review of the decision is available and 
judicial review may be immediately sought.
    In 1999, the OIG issued a report entitled ``Medicare Administrative 
Appeals--ALJ Hearing Process'' (OEI-04-97-00160) (Sept. 1999) (http://oig.hhs.gov/oei/reports/oei-04-97-00160.pdf). In that report, the OIG 
noted that the DAB respondents voiced strong interest in having 
precedent setting authority in the Medicare administrative appeals 
process ``to clean-up inconsistencies in the appeals process.'' The OIG 
recommended that such a case precedent system be established.
    Pursuant to section 931(a) of the MMA, HHS and SSA developed a plan 
for the transition of the ALJ hearing function for some types of 
Medicare appeals from SSA to HHS, and addressed the feasibility of 
precedential authority of DAB decisions. See Report to Congress: Plan 
for the Transfer of Responsibility for Medicare Appeals (Mar. 2004) 
(https://www.ssa.gov/legislation/medicare/medicare_appeal_transfer.pdf). HHS determined that at that time, it was 
not feasible or appropriate to confer precedential authority on Council 
decisions, but indicated that it would reevaluate the merits of 
granting precedential authority to some or all Council decisions after 
the BIPA and MMA changes to the appeals process were fully implemented.
    BIPA and MMA changes to the appeals process have now been fully 
implemented and we believe it is appropriate to propose that select 
Council decisions be made precedential to increase consistency in 
decisions at all levels of appeal for appellants. Proposed Sec.  
401.109 would introduce precedential authority to the Medicare claim 
and entitlement appeals process under part 405, subpart I; part 422, 
subpart M; part 423, subparts M and U; and part 478, subpart B. 
Proposed Sec.  401.109(a) would grant authority to the Chair of the DAB 
to designate a final decision of the Secretary issued by the Council as 
precedential. We believe this would provide appellants with a 
consistent body of final decisions of the Secretary upon which they 
could determine whether to seek appeals. It would also assist appeal 
adjudicators at all levels of appeal by providing clear direction on 
repetitive legal and policy questions, and in limited circumstances, 
factual questions. In the limited circumstances in which a precedential 
decision would apply to a factual question, the decision would be 
binding where the relevant facts are the same and evidence is presented 
that the underlying factual circumstances have not changed since the 
Council issued the precedential final decision.
    It is appropriate for the DAB Chair to have the role of designating 
select Council decisions as precedential. The DAB Chair leads the DAB, 
which was established in 1973. The DAB has wide jurisdiction over 
disputes arising under many HHS programs and components, and has issued 
precedential decisions for many years within several of its areas of 
jurisdiction. (Examples of DAB jurisdiction may be found at 45 CFR part 
16, 42 CFR part 498, 42 CFR part 426, and on the DAB's Web site at 
www.hhs.gov/dab.) The Council has been housed within the DAB as an 
organization since 1995 and is itself also under the leadership of the 
DAB Chair. Thus, the DAB Chair brings both expertise in the Medicare 
claims appeals over which the Council has jurisdiction and experience 
from the DAB's precedential cases to carrying out the role of 
designating Council decisions to be precedential. Moreover, having the 
designation performed by the DAB Chair respects the continued 
independence of the Council as an adjudicative body by allowing the DAB 
to determine the effect of its own decisions. Limiting binding 
precedential effect to selected decisions provides the necessary 
discretion to designate as precedential those Council decisions in 
which a significant legal or factual issue was fully developed on the 
record and thoroughly analyzed. Designation might not be appropriate 
where an issue was mentioned in the decision as relevant but was not 
outcome determinative, and therefore may not have been as fully 
developed as is necessary for precedential decisions or where the 
issues addressed are not likely to have broad application beyond the 
particular case.
    To help ensure appellants and other stakeholders are aware of 
Council decisions that are designated as precedential, we are proposing 
that Sec.  401.109(b) would require notice of precedential decisions to 
be published in the Federal Register, and the decisions themselves 
would be made available to the public, with necessary precautions taken 
to remove personally identifiable information that cannot be disclosed 
without the individual's consent. Designated precedents would be posted 
on an accessible Web site maintained by HHS. Decisions of the Council 
would bind all lower-level decision-makers from the date that the 
decisions are posted on the HHS Web site.
    Proposed Sec.  401.109(c) would make these precedential decisions 
binding on all CMS components, on all HHS components that adjudicate 
matters under the jurisdiction of CMS, and on SSA to the extent that 
SSA components adjudicate matters under the jurisdiction of CMS, in the 
same manner as CMS Rulings under current Sec.  401.108. That means the 
precedential decision would be binding on CMS and its contractors in 
making initial determinations, redeterminations, and reconsiderations, 
under part 405 subpart I, or equivalent determinations under parts 422 
subpart M, 423 subparts M and U, and 478 subpart B; OMHA ALJs and, as 
proposed in II.B below, attorney adjudicators; the Council in its 
future decisions; and SSA to the extent that it adjudicates matters 
under the jurisdiction of CMS. Individual determinations and decisions 
by CMS contractors, OMHA ALJs, and the Council currently are not 
precedential and have no binding effect on future initial 
determinations (and equivalent determinations) or claims appeals. We 
are not proposing to change the non-precedential status and non-binding 
effect on future initial determinations (and equivalent determinations) 
or claim appeals of any determinations or decisions except as to 
Council decisions designated as precedential by the DAB Chair.
    Proposed Sec.  401.109(d) would specify the scope of the 
precedential effect of a Council decision designated by the DAB Chair. 
The Council's legal analysis and interpretation of an authority or 
provision that is binding (see, for example Sec. Sec.  405.1060 and 
405.1063) or owed substantial deference (see, for example Sec.  
405.1062) would be binding in future determinations and appeals in 
which the same authority or provision is applied and is still in 
effect. However, if CMS revises the authority or provision that is the 
subject of a precedential decision, the Council's legal analysis and 
interpretation would not be binding on claims or other disputes to 
which the revised authority or provision applies. For example, if a 
Council decision designated as precedential by the DAB Chair interprets 
a CMS manual instruction, that interpretation would be binding on 
pending and future appeals and initial determinations to which that 
manual instruction applies. However, CMS would be free to follow its 
normal internal process to revise the manual instruction at issue. Once 
the revised instruction is issued through the CMS process, the revised 
instruction would

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apply to making initial determinations on all claims thereafter. This 
would help ensure that CMS continues to have the ultimate authority to 
administer the Medicare program and promulgate regulations, and issue 
sub-regulatory guidance and policies on Medicare coverage and payment.
    If the decision is designated as precedential by the DAB Chair, 
proposed Sec.  401.109(d) would also make the Council's findings of 
fact binding in future determinations and appeals that involve the same 
parties and evidence. For example, if a precedential Council decision 
made findings of fact related to the issue of whether an item qualified 
as durable medical equipment and the same issue was in dispute in 
another appeal filed by the same party, and that party submitted the 
same evidence to support its assertion, the findings of fact in the 
precedential Council decision would be binding. However, we note that 
many claim appeals turn on evidence of a beneficiary's condition or 
care at the time discrete items or services are furnished, and 
therefore proposed Sec.  401.109 is unlikely to apply to findings of 
fact in these appeals.
    In addition, consistent with proposed Sec.  401.109, we are 
proposing at Sec.  405.968(b)(1) to add precedential decisions 
designated by the Chair of the Departmental Appeals Board as an 
authority that is binding on the QIC. We are also proposing at 
Sec. Sec.  405.1063 and 423.2063, which currently cover the 
applicability of laws, regulations, and CMS Rulings, to add new 
paragraph (c) to the sections to provide that precedential decisions 
designated by the Chair of the Departmental Appeals Board in accordance 
with Sec.  401.109 are binding on all CMS components, all HHS 
components that adjudicate matters under the jurisdiction of CMS, and 
on the Social Security Administration to the extent that components of 
the Social Security Administration adjudicate matters under the 
jurisdiction of CMS. Finally, we are proposing to add precedential 
decisions to the titles of Sec. Sec.  405.1063 and 423.2063 to reflect 
the additional topic covered by proposed paragraph (c).
    We are inviting public comments on these proposals. If you choose 
to comment on the proposals in this section, please include the caption 
``Precedential final decisions of the Secretary'' at the beginning of 
your comment.

B. Attorney Adjudicators

    Sections 1155, 1852(g)(5), 1860D-4(h), 1869(b)(1)(A), and 
1876(c)(5)(B) provide a right to a hearing to the same extent as 
provided in section 205(b) by the HHS Secretary for certain appealable 
decisions by Medicare contractors or SSA, when the amount in 
controversy and other filing requirements are met. Hearings under these 
statutory provisions are conducted by OMHA ALJs with delegated 
authority from the HHS Secretary, in accordance with these sections and 
the APA.
    Under current Sec. Sec.  405.1038 and 423.2038, OMHA ALJs are also 
responsible for a portion of the appeals workload that does not require 
a hearing because a request for an ALJ hearing may also be addressed 
without conducting a hearing. For example, under Sec. Sec.  405.1038 
and 4423.2038, if the evidence in the hearing record supports a finding 
in favor of the appellant(s) on every issue, or if all parties agree in 
writing that they do not wish to appear before the ALJ at a hearing, 
the ALJ may issue a decision on the record without holding a hearing. 
Under current Sec. Sec.  405.1052(a)(1) and 423.2052(a)(1), OMHA ALJs 
must also address a large number of requests to withdraw requests for 
ALJ hearings, which appellants often file pursuant to litigation 
settlements, law enforcement actions, and administrative agreements in 
which they agree to withdraw appeals and not seek further appeals of 
resolved claims. In addition, pursuant to Sec. Sec.  405.1004 and 
423.2004, OMHA ALJs review whether a QIC or IRE dismissal was in error. 
Under these sections, the ALJ reviews the dismissal, but no hearing is 
required. In FY 2015, OMHA ALJs addressed approximately 370 requests to 
review whether a QIC or IRE dismissal was in error. Also adding to the 
ALJs' workload are remands to Medicare contractors for information that 
can only be provided by CMS or its contractors under current Sec. Sec.  
405.1034(a) and 423.2034(a), and for further case development or 
information at the direction of the Council. Staff may identify the 
basis for these remands before an appeal is assigned to an ALJ and a 
remand order is prepared, but an ALJ must review the appeal and issue 
the remand order, taking the ALJ's time and attention away from 
hearings and making decision on the merits of appeals.
    Under section 1869(d) of the Act, an ALJ must conduct and conclude 
a hearing on a decision of a QIC under subsection (c). Subsection (c) 
of section 1869 of the Act involves the conduct of reconsiderations by 
QICs. We believe that the statute does not require the action to be 
taken by an ALJ in cases where there is no QIC reconsideration (for 
example, where the QIC has issued a dismissal), or in cases of a remand 
or a withdrawal of a request for an ALJ hearing, and therefore the 
findings of fact and conclusions of law need not be rendered. ALJ 
hearings are ideally suited to obtain testimony and other evidence, and 
hear arguments related to the merits of a claim or other determination 
on appeal. ALJs are highly qualified to conduct those hearings and make 
findings of fact and conclusions of law to render a decision in the 
more complex records presented with a mix of documentary and 
testimonial evidence. However, well-trained attorneys can perform a 
review of the administrative record and more efficiently draft the 
appropriate order for certain actions, such as issuing dismissals based 
on an appellant's withdrawal of a request for an ALJ hearing, remanding 
appeals for information or at the direction of the Council, and 
conducting reviews of QIC and IRE dismissals.
    In addition, current Sec. Sec.  405.1038 and 423.2038 provide 
mechanisms for deciding cases without an oral hearing, based on the 
written record. Cases may be decided without an oral hearing when the 
record supports a finding in favor of the appellant(s) on every issue; 
all of the parties have waived the oral hearing in writing; or the 
appellant lives outside of the United States and did not inform the ALJ 
that he or she wishes to appear, and there are no other parties who 
wish to appear. In these circumstances, the need for an experienced 
adjudicator knowledgeable in Medicare coverage and payment law 
continues, and well-trained attorneys can review the record, identify 
the issues, and make the necessary findings of fact and conclusions of 
law when the regulations do not require a hearing to issue a decision 
in the appealed matter.
    To enable OMHA to manage requests for an ALJ hearing and requests 
for reviews of QIC and IRE dismissals in a more timely manner and 
increase service to appellants, while preserving access to a hearing 
before an ALJ in accordance with the statutes, we are proposing to 
revise rules throughout part 405, subparts I and J; part 422, subpart 
M; part 423, subparts M and U; and part 478, subpart B, to provide 
authority that would allow attorney adjudicators to issue decisions 
when a decision can be issued without an ALJ conducting a hearing under 
the regulations, dismissals when an appellant withdraws his or her 
request for an ALJ hearing, and remands for information that can only 
be provided by CMS or its contractors or at the direction of the 
Council; as well as to conduct reviews of QIC and IRE dismissals. We 
also are proposing to revise the rules so that decisions and

[[Page 43795]]

dismissals issued by attorney adjudicators may be reopened and/or 
appealed in the same manner as equivalent decisions and dismissals 
issued by ALJs. Allowing attorney adjudicators to issue decisions, 
dismissals, and remands as described above, and to conduct reviews of 
QIC and IRE dismissals would expand the pool of OMHA adjudicators and 
allow ALJs to focus on cases going to a hearing, while still providing 
appellants with quality reviews and decisions, dismissals, and remands. 
In addition, the rights associated with an appeal adjudicated by an ALJ 
would extend to any appeal adjudicated by an attorney adjudicator, 
including any applicable adjudication time frame, escalation option, 
and/or right of appeal to the Council.
    In addition, we note that even if an attorney adjudicator was 
assigned to adjudicate a request for an ALJ hearing, that hearing 
request still could be reassigned to an ALJ for an oral hearing if the 
attorney adjudicator determined that a hearing could be necessary to 
render a decision. For example, if the parties waived their rights to 
an oral hearing in writing, allowing a decision to be issued without 
conducting an oral hearing in accordance with current Sec. Sec.  
405.1038(b)(1) or 423.2038(b)(1), but the attorney adjudicator believed 
testimony by the appellant or another party would be necessary to 
decide the appeal, the attorney adjudicator would refer the appeal to 
an ALJ to determine whether conducting an oral hearing would be 
necessary to decide the appeal regardless of the waivers, pursuant to 
current Sec. Sec.  405.1036(b)(3) or 423.2036(b)(3). We also note that 
parties to a decision that is issued without an ALJ conducting an oral 
hearing pursuant to current Sec. Sec.  405.1038(a) or 423.2038(a) (that 
is, the decision is favorable to the appellant on every issue and 
therefore may be issued based on the record alone) continue to have a 
right to a hearing and a right to examine the evidence on which the 
decision is based and may pursue that right by requesting a review of 
the decision by the Council, which can remand the case for an ALJ to 
conduct a hearing and issue a new decision.
    To implement this proposal, we are proposing to revise provisions 
throughout part 405 subpart I, part 422 subpart M, part 423 subparts M 
and U, and part 478 subpart U, as detailed in proposed revisions to 
specific sections, in section III of this proposed rule, below. In 
addition, we are proposing to define an attorney adjudicator in Sec.  
405.902, which provides definitions that apply to part 405 subpart I. 
We are proposing to define an ``attorney adjudicator'' in Sec.  405.902 
as a licensed attorney employed by OMHA with knowledge of Medicare 
coverage and payment laws and guidance. In addition, we are proposing 
to indicate in Sec.  405.902 that the attorney adjudicator is 
authorized to take the actions provided for in subpart I on requests 
for ALJ hearing and requests for reviews of QIC dismissals. These 
proposals would provide the public with an understanding of the 
attorney adjudicator's qualifications and scope of authority, and we 
also note that attorney adjudicators would receive the same training as 
OMHA ALJs.
    We are inviting public comments on these proposals. If you choose 
to comment on the proposals in this section, please include the caption 
``Attorney Adjudicators'' at the beginning of your comment.

C. Application of 405 Rules to Other Parts

    Current Sec.  422.562(d) states that unless subpart M regarding 
grievances, organization determinations and appeals under the Medicare 
Advantage program provides otherwise, the regulations found in part 405 
apply under subpart M to the extent appropriate. In addition, current 
Sec.  422.608, which is a section within subpart M, provides that the 
regulations under part 405 regarding Council review apply to the 
subpart to the extent that they are appropriate.
    Similar to current Sec.  422.562(d), Sec.  478.40(c) indicates that 
the part 405 regulations apply to hearings and appeals under subpart B 
of part 478 regarding QIO reconsiderations and appeals, unless they are 
inconsistent with specific provisions in subpart B. Thus, the part 405 
rules are used, to the extent appropriate, for administrative review 
and hearing procedures in the absence of specific provisions related to 
administrative reviews and hearing procedures in part 422, subpart M; 
and part 478, subpart B, respectively. These general references to part 
405 are often helpful in filling in gaps in procedural rules when there 
is no rule on point in the respective part. However, there has been 
confusion on the application of part 405 rules when a part 405 rule 
implements a specific statutory provision that is not in the 
authorizing statute for the referring subpart and HHS has not adopted a 
similar policy for the referring subpart in its discretion to 
administer the Medicare Advantage, QIO, and cost plan appeals programs. 
For example, certain procedures and provisions of section 1869 of the 
Act (governing certain determinations and appeals under Medicare Part A 
and Part B) that are implemented in part 405, subpart I are different 
than or not addressed in sections 1155 (providing for reconsiderations 
and appeals of QIO determinations), 1852(g) (providing for appeals of 
MA organization determinations), and 1876 (providing for appeals of 
organization determinations made by section 1876 health maintenance 
organizations (HMOs) and competitive medical plans (CMPs). Section 1869 
of the Act provides for, among other things, redeterminations of 
certain initial determinations, QIC reconsiderations following 
redeterminations or expedited determinations; ALJ hearings and 
decisions following a QIC reconsideration; DAB review following ALJ 
decisions; specific time frames in which to conduct the respective 
adjudications; and, at certain appeal levels, the option to escalate 
appeals to the next level of appeal if the adjudication time frames are 
not met. In addition, section 1869(b)(3) of the Act does not permit 
providers and suppliers to introduce evidence in an appeal brought 
under section 1869 of the Act after the QIC reconsideration, unless 
there is good cause that precluded the introduction of the evidence at 
or before the QIC reconsideration.
    In contrast, sections 1852(g)(5) of the Act and 1876(c)(5)(B) of 
the Act incorporate some, but not all, of the provisions of section 
1869 of the Act, and add certain requirements, such as making the MAO, 
HMO, or CMP a party to an ALJ hearing. For example, sections 1852(g)(5) 
and 1876(c)(5)(B) of the Act specifically incorporate section 
1869(b)(1)(E)(iii) of the Act to align the amount in controversy 
requirements for an ALJ hearing and judicial review among the three 
sections. However, sections 1852(g) and 1876(c)(5)(B) do not 
incorporate adjudication time frames and escalation provisions, or the 
limitation on new evidence provision of section 1869(b)(3) of the Act.
    Additionally, section 1155 of the Act provides for an individual's 
right to appeal certain QIO reconsidered determinations made under 
section 1154 of the Act directly to an ALJ for hearing. However, 
section 1155 of the Act does not reference section 1869 of the Act or 
otherwise establish an adjudication time frame, and provides for a 
different amount in controversy requirement for an ALJ hearing.
    Despite these statutory distinctions, HHS has established similar 
procedures by regulation to the extent practicable, when not addressed 
by statute. For example, section 1860D-4(h) of the Act, which addresses 
appeals of coverage

[[Page 43796]]

determinations under Medicare Part D, incorporates paragraphs (4) and 
(5) of section 1852(g) of the Act. As discussed above, section 1852(g) 
does not incorporate adjudication time frames from section 1869 of the 
Act or otherwise establish such time frames. However, through 
rulemaking for Part D coverage determination appeals, HHS has adopted a 
90-day adjudication time frame for standard requests for an ALJ hearing 
and requests for Council review of an ALJ decision, as well as a 10-day 
adjudication time frame when the criteria for an expedited hearing or 
review are met.
    To clarify the application of the part 405 rules, we are proposing 
revisions to parts 422 and 478. Proposed Sec. Sec.  422.562(d) and 
422.608 would provide that the part 405 rules do not apply when the 
part 405 rule implements a statutory provision that is not also 
applicable to section 1852 of the Act. Similarly, proposed Sec.  
478.40(c) would provide that the part 405 rules do not apply when the 
part 405 rule implements a statutory provision that is not also 
applicable to section 1155 of the Act. In addition, proposed Sec.  
478.40(c) removes language that equates an initial determination and 
reconsidered determination made by a QIO to contractor initial 
determinations and reconsidered determinations under part 405 because 
that language has caused confusion with provisions that are specific to 
part 405 and QIC reconsiderations, and it is not necessary to apply the 
remaining part 405, subpart I procedural rules in part 478, subpart B 
proceedings. In addition to clarifying the application of part 405 
rules to other parts, these revisions would help ensure that statutory 
provisions that are specific to certain Medicare appeals are not 
applied to other appeals without HHS first determining, through 
rulemaking, whether it would be appropriate to apply a provision and 
how best to tailor aligning policies for those other appeals.
    We are inviting public comments on these proposals. If you choose 
to comment on the proposals in this section, please include the caption 
``Application of part 405 rules to other parts'' at the beginning of 
your comment.

D. OMHA References

    When the 2005 Interim Final Rule was published in March 2005, 
implementing the part 405, subpart I rules, OMHA was not yet in 
operation. Further, processes and procedures were being established 
under the part 405 subpart I rules, with new CMS contractors and the 
newly transitioned ALJ hearing function. Since that time, OMHA and CMS 
and its contractors have developed operating arrangements to help 
ensure appeals flow between CMS contractors and OMHA, and that appeal 
instructions for appellants provide clear direction on how and where to 
file requests for hearings and reviews. However, many of the current 
rules for the ALJ hearing program that OMHA administers reflect the 
transition that was occurring at the time of the 2005 Interim Final 
Rule, and OMHA is not mentioned in the regulation text.
    To provide clarity to the public on the role of OMHA in 
administering the ALJ hearing program, and to clearly identify where 
requests and other filings should be directed, we are proposing to 
define OMHA in Sec.  405.902 as the Office of Medicare Hearings and 
Appeals within the U.S. Department of Health and Human Services, which 
administers the ALJ hearing process in accordance with section 
1869(b)(1) of the Act. We are also proposing to amend rules throughout 
part 405, subparts I and J; part 422, subpart M; part 423, subparts M 
and U; and part 478, subpart B to reference OMHA or an OMHA office, in 
place of current references to an unspecified entity, ALJs, and ALJ 
hearing offices, when a reference to OMHA or an OMHA office provides a 
clearer explanation of a topic. To implement this proposal, we are 
proposing to revise provisions throughout part 405 subparts I and J, 
part 422 subpart M, part 423 subparts M and U, and part 478 subpart U, 
as detailed in proposed revisions to specific sections, in section III 
of this proposed rule, below.
    We are inviting public comments on these proposals. If you choose 
to comment on the proposals in this section, please include the caption 
``OMHA references'' at the beginning of your comment.

E. Medicare Appeals Council References

    The Council is currently referred to as the ``MAC'' throughout 
current part 405, subpart I; part 422, subpart M; and part 423, 
subparts M and U. This reference has caused confusion in recent years 
with the transition from Fiscal Intermediaries and Carriers, to 
Medicare administrative contractors--for which the acronym ``MAC'' is 
also commonly used--to process claims and make initial determinations 
and redeterminations in the Medicare Part A and Part B programs. In 
addition, current Sec. Sec.  422.618 and 422.619 reference the Medicare 
Appeals Council but use ``Board'' as the shortened reference, and part 
478, subpart B, references the DAB as the reviewing entity for appeals 
of ALJ decisions and dismissals but the Council is the entity that 
conducts reviews of ALJ decisions and dismissals, and issues final 
decisions of the Secretary for Medicare appeals under part 478, subpart 
B.
    To address potential confusion with references to Medicare 
administrative contractors and align references to the Council as the 
reviewing entity for appeals of ALJ decisions and dismissals throughout 
part 405, subpart I; part 422, subpart M; and part 423, subparts M and 
U, we are proposing to amend the following rules to replace ``MAC'' or 
``Board'' with ``Council'': Sec. Sec.  405.902, 405.904, 405.906, 
405.908, 405.910, 405.926, 405.980, 405.982, 405.984, 405.990, 
405.1026, 405.1036, 405.1037, 405.1042, 405.1046, 405.1048, 405.1050, 
405.1052, 405.1054, 405.1060, 405.1063, 405.1062, 405.1100, 405.1102, 
405.1104 (as re-designated and revised as proposed Sec.  405.1016(e)-
(f)), 405.1106, 405.1108, 405.1110, 405.1112, 405.1114, 405.1116, 
405.1118, 405.1120, 405.1122, 405.1124, 405.1126, 405.1128, 405.1130, 
405.1132, 405.1134, 405.1136, 405.1138, 405.1140, 422.561, 422.562, 
422.608, 422.612, 422.616, 422.618, 422.619, 422.622, 422.626, 423.560, 
423.562, 423.1968, 423.1974, 423.1976, 423.1978, 423.1980, 423.1982, 
423.1984, 423.1990, 423.2026, 423.2036, 423.2042, 423.2046, 423.2048, 
423.2050, 423.2052, 423.2054, 423.2062, 423.2063, 423.2100, 423.2102, 
423.2106, 423.2108, 423.2110, 423.2112, 423.2114, 423.2116, 423.2118, 
423.2120, 423.2122, 423.2124, 423.2126, 423.2128, 423.2130, 423.2134, 
423.2136, 423.2138, and 423.2140.
    In addition, to align references to the Council as the reviewing 
entity for appeals of ALJ decisions and dismissals in part 478, subpart 
B, we are proposing to amend Sec. Sec.  478.46 and 478.48 to replace 
``Departmental Appeals Board'' and ``DAB,'' with ``Medicare Appeals 
Council'' and ``Council''.
    We are inviting public comments on these proposals. If you choose 
to comment on the proposals in this section, please include the caption 
``Medicare Appeals Council references'' at the beginning of your 
comment.

III. Specific Provisions of the Proposed Rule

A. Provisions of Part 405, Subpart I and Part 423, Subparts M and U

1. Overview
    Part 405, subpart I and part 423, subpart U contain detailed 
procedures for requesting and adjudicating a request for an ALJ 
hearing, and a request for a review of a QIC or IRE dismissal. Part 
423, subpart U provisions were proposed in the March 17, 2008 Federal

[[Page 43797]]

Register (73 FR 14342) and made final in the December 9, 2009 Federal 
Register (74 FR 65340), and generally follow the part 405, subpart I 
procedures. In this proposed rule, we generally discuss proposals 
related to part 405, subpart I, and then whether any aligning revisions 
to part 423, subpart U, are proposed, unless a provision is specific to 
Part 405 and there is no corresponding part 423 provision.
2. General Provisions, Reconsiderations, Reopenings, and Expedited 
Access to Judicial Review
a. Part 423, Subpart M General Provisions (Sec.  423.562)
    Current Sec.  423.562(b)(4) lists the appeal rights of a Part D 
plan enrollee, if the enrollee is dissatisfied with any part of a 
coverage determination. Specifically, paragraph (b)(4)(v) describes the 
right to request Council review of the ALJ's hearing decision if the 
ALJ affirms the IRE's adverse coverage determination in whole or in 
part, and paragraph (b)(4)(vi) describes the right to judicial review 
of the hearing decision if the Council affirms the ALJ's adverse 
coverage determination in whole or in part, and the amount in 
controversy requirements are met. We are proposing to revise paragraph 
(b)(4)(v) to insert ``or attorney adjudicator'' after each instance of 
``the ALJ.'' This proposal is necessary to implement the proposal to 
allow attorneys to adjudicate requests for an ALJ hearing when no 
hearing is conducted as proposed in section II.B above, by stating the 
right to request Council review of an attorney adjudicator decision 
that affirms the IRE's adverse coverage determination. We also are 
proposing to remove ``hearing'' before ``decision'' in paragraph 
(b)(4)(v) to reflect that an attorney adjudicator issues decisions 
without conducting a hearing, and an ALJ may issue a decision without 
conducting a hearing.
    In paragraph (b)(4)(vi), we are proposing to remove ``ALJ's'' and 
insert ``ALJ's or attorney adjudicator's'' in its place to implement 
the proposal to allow attorneys to adjudicate requests for an ALJ 
hearing when no hearing is conducted as proposed in section II.B above, 
by including an attorney adjudicator's decision as a decision that may 
be affirmed by the Council. We also are proposing to remove ``hearing'' 
before ``decision'' in paragraph (b)(4)(vi) because while the Council 
may conduct a hearing, Council decisions are generally issued without 
conducting a hearing, and the decision of the Council is subject to 
judicial review.
    We are inviting public comments on these proposals. If you choose 
to comment on the proposals in this section, please include the caption 
``Part 423, subpart M general provisions'' at the beginning of your 
comment.
b. Part 423, Subpart U Title and Scope (Sec.  423.1968)
    The current heading of part 423, subpart U references ALJ hearings 
but does not reference decisions. We are proposing to revise the 
heading by replacing ``ALJ Hearings'' with ``ALJ hearings and ALJ and 
attorney adjudicator decisions'' to reflect that subpart U covers 
decisions by ALJs and attorney adjudicators, as proposed in section 
II.B above.
    Current Sec.  423.1968 explains the scope of the requirements in 
subpart U. We are proposing at Sec.  423.1968 to expand the scope of 
subpart U to include actions by attorney adjudicators, as proposed in 
section II.B above. Specifically, we are proposing at Sec.  423.1968(a) 
to add that subpart U sets forth requirements relating to attorney 
adjudicators with respect to reopenings; at Sec.  423.1968(b) to add 
that subpart U sets forth requirements relating to ALJ decisions and 
decisions of attorney adjudicators if no hearing is conducted; and at 
Sec.  423.1968(d) to add that subpart U sets forth the requirements 
relating to Part D enrollees' rights with respect to ALJ hearings and 
ALJ or attorney adjudicator reviews. These changes would be necessary 
to accurately describe the scope of the revised provisions of subpart U 
to implement the attorney adjudicator proposal discussed in section 
II.B above.
    We are inviting public comments on these proposals. If you choose 
to comment on the proposals in this section, please include the caption 
``Part 423, subpart U title and scope'' at the beginning of your 
comment.
c. Medicare Initial Determinations, Redeterminations and Appeals 
General Description (Sec.  405.904)
    Section 405.904(a) provides a general overview of the entitlement 
and claim appeals process to which part 405, subpart I applies. Current 
paragraphs (a)(1) and (a)(2) provide that if a beneficiary obtains a 
hearing before an ALJ and is dissatisfied with the decision of the ALJ, 
the beneficiary may request that the Council review the case. To 
provide for the possibility that a decision may be issued without 
conducting a hearing by an ALJ, as permitted under current rules, or an 
attorney adjudicator, as proposed in II.B above, we are proposing to 
add language in paragraphs (a)(1) and (a)(2) to provide that if the 
beneficiary is dissatisfied with the decision of an ALJ or attorney 
adjudicator when no hearing is conducted, the beneficiary may request 
that the Council review the case. This proposal would provide a 
comprehensive overview of the entitlement and claim appeals process, 
with information on the potential for and right to appeal decisions by 
ALJs when no hearing is conducted, and the right to appeal decisions by 
attorney adjudicators, if the attorney adjudicator proposals are made 
final.
    We are inviting public comments on this proposal. If you choose to 
comment on the proposal in this section, please include the caption 
``Medicare initial determinations, redeterminations and appeals general 
description'' at the beginning of your comment.
d. Parties to the Initial Determinations, Redeterminations, 
Reconsiderations, Proceedings on a Request for Hearing, and Council 
Review (Sec.  405.906)
    Current Sec.  405.906 discusses parties to the appeals process and 
subsection (b) currently addresses parties to the redetermination, 
reconsideration, hearing and MAC. We are proposing in the paragraph 
heading and introductory text to subsection (b) to replace the phrases 
``hearing and MAC'' and ``hearing, and MAC review,'' respectively, with 
``proceedings on a request for hearing, and Council review'' because, 
absent an assignment of appeal rights, the parties are parties to all 
of the proceedings on a request for hearing, including the hearing if 
one is conducted, and they are parties to the Council's review.
    We are inviting public comments on this proposal. If you choose to 
comment on the proposal in this section, please include the caption 
``Parties to the initial determinations, redeterminations, 
reconsiderations, hearings, and reviews'' at the beginning of your 
comment.
e. Medicaid State Agencies (Sec.  405.908)
    Current Sec.  405.908 discusses the role of Medicaid State agencies 
in the appeals process and states that if a State agency files a 
request for redetermination, it may retain party status at the QIC, 
ALJ, MAC and judicial review levels. We are proposing to replace 
``ALJ'' with ``OMHA'' to provide that the State agency has party status 
regardless of the adjudicator assigned to the State agency's request 
for an ALJ hearing or request for review of a QIC dismissal at the OMHA 
level of review, as attorney adjudicators may issue decisions on

[[Page 43798]]

requests for hearing and adjudicate requests for reviews of QIC 
dismissals, as proposed in section II.B above.
    We are inviting public comments on this proposal. If you choose to 
comment on the proposal in this section, please include the caption 
``Medicaid State agencies'' at the beginning of your comment.
f. Appointed Representatives (Sec.  405.910)
    The 2002 Proposed Rule (67 FR 69318 through 69319) explained that 
the Sec.  405.910 requirements for a valid appointment of a 
representative are necessary to help ensure that adjudicators are 
sharing and disseminating confidential information with the appropriate 
individuals. The 2005 Interim Final Rule (70 FR 11428 through 11431) 
adopted a general requirement to include a beneficiary's health 
insurance claim number (HICN) for a valid appointment of a 
representative in Sec.  405.910(c)(5). The SMART Act Final Rule (80 FR 
10614, 10617) revised Sec.  405.910(c)(5) to explicitly limit the 
requirement to include a beneficiary's HICN to instances in which the 
beneficiary is the party appointing a representative. However, the 
Medicare manual provision for completing a valid appointment of 
representative (Medicare Claims Processing Manual (Internet-Only Manual 
100-4), chapter 29, Sec.  270.1.2) details the requirements for an 
appointment of representation to contain a unique identifier of the 
party being represented. Specifically, if the party being represented 
is the beneficiary, the Medicare number must be provided, and if the 
party being represented is a provider or supplier, the National 
Provider Identifier (NPI) number should be provided. Additionally, the 
official form for executing a valid appointment of representative (form 
CMS-1696, available at https://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/Downloads/CMS1696.pdf) provides a blank space for the party to 
include a Medicare or NPI number. To assist adjudicators in sharing and 
disseminating confidential information only with appropriate 
individuals, we are proposing to revise Sec.  405.910(c)(5) to add a 
requirement to include the Medicare NPI of the provider or supplier 
that furnished the item or service when the provider or supplier is the 
party appointing a representative. We are retaining the requirement to 
identify the beneficiary's Medicare HICN when the beneficiary is the 
party appointing a representative.
    Current Sec.  405.910 also addresses defective appointments, and 
delegations and revocations of appointments. However, there has been 
confusion on the effects on the adjudication of an appeal when a 
defective appointment must be addressed, or when an adjudicator is not 
timely informed of a delegation or revocation of an appointment. To 
address the effect of a defective appointment on the adjudication of an 
appeal to which an adjudication time frame applies, we are proposing to 
add Sec.  405.910(d)(3), which would extend an applicable adjudication 
time frame from the later of (1) the date that a defective appointment 
of representative was filed or (2) the date the current appeal request 
was filed by the prospective appointed representative, to the date that 
the defect in the appointment was cured or the party notifies the 
adjudicator that he or she will proceed with the appeal without a 
representative. We are proposing this revision because, in accordance 
with current Sec.  405.910(d)(1) and (d)(2), a prospective appointed 
representative lacks the authority to act on behalf of a party and is 
not entitled to obtain or receive any information related to the 
appeal. Thus, contact with the party may be necessary to obtain missing 
information from the appointment, which may delay adjudicating the 
appeal until the appointment is cured or the party decides to proceed 
with the appeal without a representative. However, we are proposing 
that if the request was filed by a prospective appointed 
representative, the request would be considered filed for the purpose 
of determining timeliness of the request, even if the individual is not 
the appointed representative after the appointment is cured, or the 
party decides to proceed with the appeal without a representative.
    We are also proposing at Sec.  405.910(f)(1) to replace ``ALJ 
level'' with ``OMHA level'' so there is no confusion that proceedings 
at the OMHA level are considered proceedings before the Secretary for 
purposes of appointed representative fees, regardless of whether the 
case is assigned to an ALJ or attorney adjudicator.
    Current Sec.  405.910(i)(2) and (i)(3) provide that if an appeal 
involves an appointed representative, an ALJ sends notices of actions 
or appeal decisions, and requests for information or evidence regarding 
a claim that is appealed to the appointed representative. We are 
proposing to insert ``or attorney adjudicator'' after ``ALJ'' in Sec.  
405.910(i)(2) and (i)(3). This proposal would provide that attorney 
adjudicators (as proposed in section II.B above), like an ALJ under the 
current provisions, would send notices of actions or appeal decisions, 
and requests for information or evidence regarding a claim that is 
appealed to the appointed representative.
    A representative and/or the represented party is responsible for 
keeping the adjudicator of a pending appeal current on the status of 
the representative. In practice, sometimes adjudicators are not 
informed of a delegation or revocation of an appointment of 
representative that has been filed for an appeal, which results in 
confusion and potentially duplicative or unnecessary proceedings. We 
are proposing to revise Sec.  405.910(l)(2) (which, as described later, 
we are proposing to re-designate as (l)(1)(ii)) to add that a 
delegation is not effective until the adjudicator receives a copy of 
the party's written acceptance of the delegation, unless the 
representative and designee are attorneys in the same law firm or 
organization, in which case the written notice to the party of the 
delegation may be submitted if the acceptance is not obtained from the 
party. This proposed revision would emphasize the importance of keeping 
adjudicators current on the status of the representative and also state 
the effects of failing to do so. Proposed Sec.  405.910(l)(2) also 
serves to assist adjudicators in sharing and disseminating confidential 
information only with appropriate individuals, and to provide 
adjudicators with appropriate contact information for scheduling 
purposes. To accommodate proposed paragraph (l)(2), current paragraph 
(l), except for the title of the paragraph, would be re-designated as 
paragraph (l)(1), and the current subparagraphs would also be re-
designated accordingly. In addition, we are proposing to add a missing 
``by'' in current paragraph (l)(1)(ii) (re-designated as (l)(1)(i)) of 
Sec.  405.910 to indicate that a designee accepts to be obligated 
``by'' and comply with the requirements of representation. We are also 
proposing to revise language in current paragraph (l)(2) (re-designated 
as (1)(l)(ii)) of Sec.  405.910 to clarify that ``this signed 
statement'' refers to the ``written statement signed by the party,'' 
and the written statement signed by the party is not required when the 
appointed representative and designee are attorneys in the same law 
firm or organization and the notice of intent to delegate under 
paragraph (l)(1)(i) indicates that fact. To further emphasize the 
importance of keeping adjudicators current on the status of the 
representative and clarify the effects of failing to do so, we are also 
proposing

[[Page 43799]]

to add Sec.  405.910(l)(3) and (m)(4) that a party's or 
representative's failure to notify the adjudicator that an appointment 
of representative has been delegated or revoked, respectively, is not 
good cause for missing a deadline or not appearing at a hearing.
    We are not proposing any changes for part 423, subpart U because it 
does not have a corresponding provision for representative 
appointments.
    We are inviting public comments on these proposals. If you choose 
to comment on the proposals in this section, please include the caption 
``Appointed representatives'' at the beginning of your comment.
g. Actions That Are Not Initial Determinations (Sec.  405.926)
    Current Sec.  405.926(l) provides that an ALJ's decision to reopen 
or not to reopen a decision is not an initial determination, and in 
accordance with the introductory language of Sec.  405.926, is 
therefore not appealable under subpart I. In section III.A.2.l below, 
we are proposing to revise the reopening rules to provide that attorney 
adjudicators would have the authority to reopen their decisions to the 
same extent that ALJs may reopen their decisions under the current 
provisions. We are proposing to insert ``or attorney adjudicator's'' 
after ``ALJ's'' in Sec.  405.926(l) to provide that the attorney 
adjudicator's decision to reopen a decision also is an action that is 
not an initial determination and therefore not an appealable action 
under subpart I.
    Current Sec.  405.926(m) provides that a determination that CMS or 
its contractors may participate in or act as parties in an ALJ hearing 
is not an initial determination, and in accordance with the 
introductory language of Sec.  405.926, is therefore not appealable 
under subpart I. As explained in section III.A.3.f below, we are 
proposing to revise Sec.  405.1010, which currently discusses when CMS 
or a contractor may participate in an ALJ hearing. As explained in the 
proposal to revise Sec.  405.1010, CMS or a contractor may elect to 
participate in the proceedings on a request for an ALJ hearing for 
which no hearing is conducted, in addition to participating in an ALJ 
hearing as a non-party participant. To align with our proposed revision 
to Sec.  405.1010, we are proposing to revise Sec.  405.926(m) to 
indicate that CMS or its contractors may participate in the full scope 
of the proceedings on a request for an ALJ hearing, including the 
hearing, by replacing ``participate in or act as parties in an ALJ 
hearing,'' with ``participate in the proceedings on a request for an 
ALJ hearing or act as parties in an ALJ hearing.''
    We are inviting public comments on these proposals. If you choose 
to comment on the proposals in this section, please include the caption 
``Actions that are not initial determinations'' at the beginning of 
your comment.
h. Notice of a Redetermination (Sec.  405.956)
    Current Sec.  405.956(b)(8) requires that the notice of a 
redetermination include a statement that evidence not submitted to the 
QIC is not considered at an ALJ hearing or further appeal, unless the 
appellant demonstrates good cause as to why that evidence was not 
provided previously. We are proposing to remove ``an ALJ hearing'' and 
add ``the OMHA level'' in its place so that the notice of a 
redetermination is clear that, absent good cause and subject to the 
exception in Sec.  405.956(d) for beneficiaries not represented by a 
provider or supplier, evidence that was not submitted to the QIC is not 
considered by an ALJ or an attorney adjudicator, as defined in Section 
II.B above.
    We are inviting public comments on this proposal. If you choose to 
comment on the proposal in this section, please include the caption 
``Notice of a redetermination'' at the beginning of your comment.
i. Time Frame for Making a Reconsideration Following a Contractor 
Redetermination, Withdrawal or Dismissal of a Request for 
Reconsideration, and Reconsideration (Sec. Sec.  405.970, 405.972, and 
405.974)
    As discussed in the 2005 Interim Final Rule (70 FR 11444 through 
11445) and the 2009 Final Rule (74 FR 65311 through 65312), HHS adopted 
a policy of providing for one level of administrative review of a 
dismissal of a request for appeal. As a result, an adjudicator's 
decision or dismissal when reviewing a dismissal action issued at the 
previous level is binding and not subject to further review. The policy 
balances a party's need for review and the need for administrative 
finality. The policy is embodied in the rules relating to reviews of 
dismissals at the next adjudicative level in current Sec. Sec.  
405.972(e), 405.974(b)(3), 405.1004(c), 405.1102(c), 405.1108(b), and 
405.1116.
    At the QIC level of appeal, a review of a contractor 
redetermination and a review of a contractor's dismissal of a request 
for a redetermination are both characterized as a ``reconsideration.'' 
While the outcome of a QIC's reconsideration of a contractor dismissal 
is differentiated and further reviews are not permitted in accordance 
with current Sec.  405.974(b)(3), an ambiguity exists with regard to 
the time frame for completing this type of reconsideration and 
escalation options when that time frame is not met. Current Sec.  
405.970 establishes the time frame for making a reconsideration without 
further qualification. However, section 1869(b)(1)(D)(i) of the Act 
establishes that a right to a reconsideration of an initial 
determination (which includes a redetermination under section 
1869(a)(3)(D) of the Act) exists if a timely request for a 
reconsideration is filed within 180 days following receipt of a 
contractor's redetermination, which is discussed in current Sec.  
405.962. In contrast, current Sec.  405.974(b)(1) requires that a 
request for a QIC reconsideration of a contractor's dismissal of a 
request for redetermination must be filed within 60 calendar days after 
receiving the contractor's notice of dismissal. Section 1869 of the Act 
does not address dismissals. Rather, section 1869(c)(3)(C)(i) and 
(c)(3)(C)(ii) of the Act only provide for a time frame to complete a 
reconsideration of an initial determination, and an option to escalate 
a case if that time frame is not met.
    The effect of the ambiguity in current Sec.  405.970 is the 
potential escalation of a request for a QIC reconsideration of a 
contractor's dismissal when the reconsideration is not completed within 
60 calendar days of a timely filed request for a reconsideration of the 
dismissal, and a potential hearing being required in accordance with 
current Sec.  405.1002(b). The potential effect of this ambiguity is 
contrary to the policy of limiting reviews of dismissals to the next 
adjudicative level of administrative appeal, as well as the statutory 
construct for providing ALJ hearings after QIC reconsiderations of 
redeterminations, or escalations of requests for reconsiderations 
following a redetermination. We also note that in the parallel context 
of an ALJ review of a QIC's dismissal of a request for reconsideration, 
current Sec. Sec.  405.1002 and 405.1004 establish a clear distinction 
between a request for hearing following a QIC reconsideration and a 
request for a review of a QIC dismissal, and current Sec. Sec.  
405.1016 and 405.1104 address the adjudication time frames for ALJ 
decisions, and the option to escalate an appeal to the Council when a 
time frame is not met, only in the context of a request for hearing, in 
accordance with section 1869(d)(1) and (d)(3)(A) of the Act.
    To address this unintended outcome of current Sec.  405.970, we are 
proposing to amend the title of Sec.  405.970 and

[[Page 43800]]

paragraphs (a), (b)(1), (b)(2), (b)(3), (c), (e)(1), and (e)(2)(i) to 
provide that the provisions would only apply to a request for a 
reconsideration following a contractor redetermination, and not to a 
request for QIC review of a contractor's dismissal of a request for 
redetermination. These proposed revisions would further our policy on 
reviews of dismissals and help appellants better understand what may be 
escalated to OMHA for an ALJ hearing. We are also proposing to replace 
``the ALJ hearing office'' in current paragraph (e)(2)(ii) with 
``OMHA'' because the QIC sends case files for escalated cases to a 
centralized location, not to individual field offices. We did not 
propose any parallel changes for part 423 because subpart U does not 
address IRE reconsiderations and subpart M does not have a provision 
with the same ambiguity.
    To provide additional clarity to the procedures for reviews of 
dismissal actions we are also proposing to amend the text in Sec. Sec.  
405.972(b)(3), (e) and 405.974(b)(3), and the introductory text of 
Sec.  405.974(b) to replace the references to a ``reconsideration'' of 
a contractor's dismissal of a request for redetermination with the word 
``review'' so that the QIC's action is referred to as a review of a 
contractor's dismissal of a request for redetermination. We are also 
proposing to revise the section heading of Sec.  405.972 to read 
``Withdrawal or dismissal of a request for reconsideration or review of 
a contractor's dismissal of a request for redetermination'' and the 
section heading of Sec.  405.974 to read, ``Reconsideration and review 
of a contractor's dismissal of a request for redetermination.'' These 
proposed revisions are consistent with the description of a 
reconsideration in section 1869(c)(3)(B)(i) of the Act and Sec.  
405.968(a). A QIC's review of a contractor dismissal action is limited 
to the appropriateness of the dismissal action and does not consist of 
a review of the initial determination and redetermination, which is the 
meaning attributed to a reconsideration. In reviewing a contractor 
dismissal action, the QIC either affirms or vacates the dismissal of 
the request for redetermination. If a dismissal action is vacated, the 
appeal is remanded back to the MAC to conduct a redetermination on the 
merits (Sec.  405.974).
    Current Sec.  405.972(e) provides that a QIC's dismissal of a 
request for reconsideration is binding unless it is modified or 
reversed by an ALJ under Sec.  405.1004. As discussed in section II.B 
above, we are proposing that an attorney adjudicator may conduct a 
review of a QIC's dismissal of a request for reconsideration and in 
section III.A.3.c below, we are proposing to revise Sec.  405.1004 to 
provide the effect of an attorney adjudicator's action taken in 
reviewing the QIC dismissal is equivalent to the effect of an ALJ's 
action taken in reviewing the QIC dismissal. To align with our proposed 
revision to Sec.  405.1004, we are proposing to insert ``or attorney 
adjudicator'' after ``an ALJ'' in Sec.  405.972(e) to indicate that a 
QIC's dismissal of a request for reconsideration is binding unless it 
is modified or reversed by an ALJ or attorney adjudicator under Sec.  
405.1004.
    We are inviting public comments on these proposals. If you choose 
to comment on the proposals in this section, please include the caption 
``Time frame for making a reconsideration following a contractor 
redetermination, withdrawal or dismissal of a request for 
reconsideration, and reconsideration'' at the beginning of your 
comment.
j. Notice of Reconsideration (Sec.  405.976)
    Section 1869(b)(3) of the Act states that a provider or supplier 
may not introduce evidence in any appeal that was not presented at the 
reconsideration conducted by a QIC unless there is good cause as to why 
the evidence was not provided prior to the issuance of the QIC's 
reconsideration. Under this authority, current Sec.  405.976(b)(5)(ii) 
provides that a notice of reconsideration must include a summary of the 
rationale for the reconsideration that specifies that all evidence that 
is not submitted prior to the issuance of the reconsideration will not 
be considered at the ALJ level, or made part of the administrative 
record, unless the appellant demonstrates good cause as to why the 
evidence was not provided prior to the issuance of the QIC's 
reconsideration; however, it does not apply to a beneficiary unless the 
beneficiary is represented by a provider or supplier or to state 
Medicaid agencies. The statement that the evidence will not be made 
part of the administrative record is inconsistent with our practice of 
making a complete record of the administrative proceedings for further 
reviews, including documents submitted by parties that were not 
considered in making the decision. Current Sec.  405.1028(c) states 
that if good cause does not exist, the ALJ must exclude the evidence 
from the proceedings and may not consider it in reaching a decision. 
However, it does not instruct the ALJ to remove the evidence from the 
administrative record, and to do so would preclude an effective review 
of the good cause determination. In addition, we noted in the 2005 
Interim Final Rule (70 FR 11464) that under current Sec.  
405.1042(a)(2), excluded evidence is part of the record because it 
states that in the record, the ALJ must also discuss any evidence 
excluded under Sec.  405.1028 and include a justification for excluding 
the evidence. To help ensure that the evidence is preserved in the 
administrative record, we are proposing to delete ``or made part of the 
administrative record'' from the paragraph in Sec.  405.976(b)(5)(ii).
    Current Sec.  405.976(b)(7) requires that the QIC notice of 
reconsideration contain a statement of whether the amount in 
controversy needed for an ALJ hearing is met when the reconsideration 
is partially or fully unfavorable. As further discussed in section 
III.A.3.d below, we are proposing revisions to Sec.  405.976(b)(7) 
along with revisions to the methodology for calculating the amount in 
controversy required for an ALJ hearing under Sec.  405.1006(d) to 
better align the amount in controversy with the actual amount in 
dispute. Please refer to section III.A.3.d for a discussion of these 
proposals.
    We are not proposing any changes to part 423 because subpart U does 
not address IRE reconsiderations and subpart M does not contain similar 
provisions.
    We are inviting public comments on this proposal. If you choose to 
comment on the proposal in this section, please include the caption 
``Notice of reconsideration'' at the beginning of your comment.
k. Effect of a Reconsideration (Sec.  405.978)
    Current Sec.  405.978 discusses the effect of a QIC 
reconsideration, and states that a reconsideration is binding on all 
parties unless, among other things, an ALJ decision is issued in 
accordance to a request for an ALJ hearing made in accordance with 
Sec.  405.1014. As discussed in section II.B above, we are proposing 
that an attorney adjudicator may issue a decision on a request for an 
ALJ hearing when a hearing is not conducted, and in section III.A.3.v 
below, we are proposing to revise Sec.  405.1048 to provide the effect 
of an attorney adjudicator's decision is equivalent to the effect of an 
ALJ's decision. To align with our proposals to provide that an attorney 
adjudicator may issue a decision on a request for an ALJ hearing when a 
hearing is not conducted and the effect of that decision is equivalent 
to the effect of an ALJ's decision, we are proposing to insert ``or 
attorney adjudicator'' after the first use of ``ALJ'' in Sec.  
405.978(a) to

[[Page 43801]]

indicate that a QIC reconsideration is binding on all parties unless, 
among other things, an ALJ or attorney adjudicator decision is issued 
in accordance to a request for an ALJ hearing made in accordance with 
Sec.  405.1014.
    We are inviting public comments on this proposal. If you choose to 
comment on the proposal in this section, please include the caption 
``Effect of a reconsideration'' at the beginning of your comment.
l. Reopenings (Sec. Sec.  405.980, 405.982, 405.984, 423.1978, 
423.1980, 423.1982, and 423.1984)
    Sections 405.980 and 423.1980 set forth the rules governing 
reopening and revision of initial determinations, redeterminations, 
reconsiderations, decisions, and reviews; Sec. Sec.  405.982 and 
423.1982 set forth the rules governing notice of a revised 
determination or decision; and Sec. Sec.  405.984 and 423.1984 set 
forth the rules on the effect of a revised determination or decision. 
Pursuant to current Sec. Sec.  405.1038 and 423.2038, an ALJ may issue 
a decision on a request for hearing without conducting a hearing in 
specified circumstances. As proposed in section II.B above, an attorney 
adjudicator also would be able to issue decisions on requests for an 
ALJ hearing in specified circumstances, issue dismissals when a party 
withdraws a request for hearing, and issue decisions on requests to 
review QIC or IRE dismissals.
    We are proposing to insert ``or attorney adjudicator'' or 
``attorney adjudicator's,'' after ``ALJ'' or ``ALJ's'' in Sec. Sec.  
405.980(a)(1)(iii), (a)(4), (a)(5), (d) introductory text, (d)(2), 
(e)(2); 405.982(a), (b); 405.984(d); 423.1980(a)(1)(iii), (a)(4), (d) 
introductory text, (d)(2), (e)(2); 423.1982(a), (a)(1), (a)(2), (b), 
(b)(1), and (b)(2); 423.1984(d); 423.1978(a); 423.1980(a)(2). These 
proposals would provide that decisions issued by attorney adjudicators, 
as proposed in section II.B above, may be reopened in the same manner 
as decisions issued by an ALJ (that is, when there is good cause in 
accordance with Sec. Sec.  405.986 or 423.1986, or the decision was 
procured by fraud or similar fault), and with the same limitations, 
requirements, and effects as reopening an ALJ decision. We believe it 
is necessary for an attorney adjudicator or the Council to have the 
authority to reopen the attorney adjudicator's decision on the same 
bases as an ALJ or the Council may reopen the ALJ's decision under the 
current rules; to address instances in which there is good cause to 
reopen the attorney adjudicator's decision (in accordance with 
Sec. Sec.  405.986 or 423.1986) or the attorney adjudicator's decision 
was procured by fraud or similar fault; and the action should be 
subject to the same limitations and requirements, and have the same 
effects as an ALJ's action under the provisions.
    We are also proposing to replace ``hearing decision,'' ``hearing 
decisions,'' or ``hearings,'' with ``decision'' or ``decisions'' in the 
titles of current Sec. Sec.  405.980 and 423.1980; Sec. Sec.  
405.980(a)(1)(iii), (d) introductory text, (d)(2), (e) introductory 
text, and (e)(2); 423.1980(a)(1)(iii), (d) introductory text, (d)(2), 
(e) introductory text, and (e)(2); to replace ``hearing'' with ``ALJ or 
attorney adjudicator decision'' in Sec. Sec.  405.980(a)(1)(iv), 
(a)(4), (e)(2); 423.1980(a)(1)(iv), (a)(2), and (e)(2); and to replace 
``ALJ hearing decisions'' and ``hearing decision,'' with ``ALJ or 
attorney adjudicator decisions'' and ``ALJ or attorney adjudicator 
decision'', respectively, in Sec. Sec.  405.984(d) and 423.1984(d). 
These proposals would avoid any confusion that reopening under these 
provisions is limited to decisions for which an oral hearing was 
conducted, whether the decision is issued by an ALJ without conducting 
a hearing, as permitted under current rules or by an attorney 
adjudicator without conducting a hearing, as proposed in section II.B 
above.
    In addition, we are proposing to add in Sec. Sec.  
405.980(a)(1)(iii), (d)(2), (e)(2), and 423.1980(a)(1)(iii), (d)(2), 
(e)(2) that an ALJ, or attorney adjudicator as proposed in section II.B 
above, revises ``his or her'' decision and may reopen ``his or her'' 
decision, which reflects our current policy that the deciding ALJ may 
reopen his or her decision, and avoids any potential confusion that an 
ALJ or attorney adjudicator may reopen the decision of another ALJ or 
attorney adjudicator. We are also proposing to insert ``its'' before 
``review'' in Sec. Sec.  405.980(a)(1)(iv) and 423.1980(a)(1)(iv) to 
indicate that the Council's review decision may only be reopened by the 
Council, to differentiate it from an ALJ or attorney adjudicator 
decision that the Council may also reopen. In addition, we are 
proposing to specify in Sec. Sec.  405.980(d)(2) and (e)(2), and 
423.1980(d)(2) and (e)(2) that the Council may reopen ``an ALJ or 
attorney adjudicator'' decision consistent with the current policy that 
the Council may reopen an ALJ decision, and to differentiate the 
provisions from Sec. Sec.  405.980(d)(3) and (e)(3), and 423.1980(d)(3) 
and (e)(3), which provide for the Council to reopen its review 
decision. We also propose in Sec.  405.980(e)(3) to insert ``Council'' 
before ``review'' to clarify that a party to a Council review may 
request that the Council reopen its decision.
    Finally, we are proposing at Sec.  405.984(c) to replace ``in 
accordance with Sec.  405.1000 through Sec.  405.1064'' with ``in 
accordance with Sec.  405.1000 through Sec.  405.1063'' to account for 
the proposed removal of Sec.  405.1064 discussed below.
    We are inviting public comments on these proposals. If you choose 
to comment on the proposals in this section, please include the caption 
``Reopenings'' at the beginning of your comment.
m. Expedited Access to Judicial Review (Sec. Sec.  405.990 and 
423.1990)
    Sections 405.990 and 423.1990 set forth the procedures governing 
expedited access to judicial review (EAJR). Current Sec. Sec.  
405.990(d) and 423.1990(d) allow a requesting party to file an EAJR 
request with an ALJ or the Council, which is then responsible for 
forwarding the request to the EAJR review entity within 5 calendar days 
of receipt. In accordance with current Sec. Sec.  405.990(f) and 
423.1990(e), a request for EAJR must be acted upon by the EAJR review 
entity within 60 calendar days after the date that the review entity 
receives a request and accompanying documents and materials. In 
practice, this process has resulted in confusion and delays for 
requesting parties when EAJR requests are sent directly to an ALJ or 
the Council. To simplify the process for requesting parties and to help 
ensure the timely processing of EAJR requests, we are proposing to 
revise Sec. Sec.  405.990(d)(1) and 423.1990(d)(1) to direct EAJR 
requests to the DAB, which administers the EAJR process. Specifically, 
we are proposing at Sec. Sec.  405.990(d)(1)(i) and (ii), and 
423.1990(d)(1)(i) and (ii) that the requestor or enrollee may file a 
written EAJR request with the DAB with the request for ALJ hearing or 
Council review if a request for ALJ hearing or Council review is not 
pending, or file a written EAJR request with the DAB if an appeal is 
already pending for an ALJ hearing or otherwise before OMHA or the 
Council. We are also proposing to revise Sec. Sec.  405.990(i)(1) and 
(2) and 423.1990(h)(1) and (2) so that the review entity would forward 
a rejected EAJR request to OMHA or the Council instead of an ALJ 
hearing office or the Council, to align with the revised EAJR filing 
process in which a request for ALJ hearing is submitted to the DAB with 
an EAJR request; this would also help ensure OMHA can process the 
request for an ALJ hearing as quickly as possible in the event an EAJR 
request is rejected.

[[Page 43802]]

    Current Sec. Sec.  405.990(i)(2) and 423.1990(h)(2) provide that a 
90 calendar day time frame will apply to an appeal when a rejected EAJR 
request is received by the hearing office or the Council. Current Sec.  
405.990(b)(1)(ii) states that an EAJR request may be filed when a 
request for a QIC reconsideration has been escalated for an ALJ 
hearing, and in accordance with current Sec.  405.1016(c), a 180 
calendar day time frame will apply in that circumstance. In addition, 
current Sec. Sec.  405.1036(d) and 423.2036(d) allow an appellant or 
enrollee to waive the adjudication period for an ALJ to issue a 
decision specified in Sec. Sec.  405.1016 and 405.2016, respectively, 
at any time during the hearing process. To address the possibility that 
a time frame other than 90 calendar days applies to an appeal, or no 
adjudication time frame applies to an appeal, we are proposing to 
revise Sec. Sec.  405.990(i)(2) and 423.1990(h)(2) to remove the 
reference to 90 calendar days and provide that if an adjudication time 
frame applies to an appeal, the adjudication time frame begins on the 
day the request for hearing is received by OMHA or the request for 
review is received by the Council, from the EAJR review entity.
    In addition, proposed Sec.  405.990(i)(1) would remove the 
redundant ``request'' after ``EAJR request'' in current paragraph 
(i)(1), which was a drafting error; and proposed Sec.  
423.1990(b)(1)(i) would remove ``final'' before referring to a 
decision, dismissal, or remand order of the ALJ or attorney 
adjudicator, as proposed in section II.B above, because as we explained 
in the 2009 Final Rule (74 FR 65307 through 65308), final decisions of 
the Secretary are those for which judicial review may be immediately 
sought under section 205(g) of the Act and the use of ``final'' in 
current Sec.  423.1990(b)(1)(i) may cause confusion with such a final 
decision.
    We are inviting public comments on these proposals. If you choose 
to comment on the proposals in this section, please include the caption 
``Expedited access to judicial review'' at the beginning of your 
comment.
3. ALJ Hearings
a. Hearing Before an ALJ and Decision by an ALJ or Attorney 
Adjudicator: General Rule (Sec. Sec.  405.1000 and 423.2000)
    Current Sec. Sec.  405.1000 and 423.2000 provide a general overview 
and rules for hearings before an ALJ and decisions on requests for 
hearings. We are proposing to revise Sec. Sec.  405.1000(d), (e), (g); 
and 423.2000(d), (e), (g) to include decisions by attorney 
adjudicators, as proposed in section II.B above. We are also proposing 
to retitle the sections to reflect that the provisions of the section 
extend to decisions by both ALJ and attorney adjudicators. We are 
proposing to change the language in Sec. Sec.  405.1000(a), (b), (c), 
and (d); and 423.2000(a) and (b) to state that a hearing may only be 
conducted by an ALJ. These proposals would provide readers with an 
accurate overview of how a request for an ALJ hearing would be 
adjudicated, including the potential that a decision could be issued 
without conducting a hearing by an ALJ or an attorney adjudicator as 
proposed in section II.B above, while informing readers that if a 
hearing is conducted, an ALJ will conduct the hearing.
    Current Sec.  405.1000(c) provides that CMS or a contractor may 
elect to participate in a hearing, and Sec.  423.2000(c) provides that 
CMS, the IRE or Part D plan sponsor may request to participate in a 
hearing. As discussed in section III.A.3.f below, we are proposing to 
revise Sec. Sec.  405.1010 and 423.2010 so that these entities may 
elect (for Sec.  405.1010) or request (for Sec.  423.2010) to 
participate in the proceedings on a request for hearing, including 
participation before a hearing is scheduled. We are proposing to revise 
Sec. Sec.  405.1000(c) and 423.2000(c) so that the sections would 
reference Sec. Sec.  405.1010 and 423.2010, respectively, with regard 
to participating in the proceedings. By referencing Sec. Sec.  405.1010 
and 423.2010, the proposed revisions would direct readers to those 
sections addressing the full scope of potential participation by CMS or 
its contractors, or a Part D plan sponsor, on a request for an ALJ 
hearing, including participating in the proceedings on a request for an 
ALJ hearing, which as discussed in proposed Sec. Sec.  405.1010 and 
423.2010, may include any proceedings before an oral hearing is 
scheduled. We are also proposing in Sec.  405.1000(c) to state that CMS 
or its contractor may join the hearing before an ALJ as a party under 
Sec.  405.1012, which would direct readers to the appropriate section 
addressing the full scope of CMS or its contractor acting as a party. 
(Because CMS, the IRE, and the Part D plan sponsor may not be a party 
to a hearing under part 423, subpart U, there is no corollary to Sec.  
405.1012 in that subpart and therefore a similar revision is not 
proposed for Sec.  423.2000(c).)
    Current Sec. Sec.  405.1000(d) and 423.2000(d) provide that a 
decision is based on the hearing record, and current Sec. Sec.  
405.1000(g) and 423.2000(g) reference a hearing record in describing 
when a decision can be issued based on the record, without a hearing. 
However, current Sec. Sec.  405.1042 and 423.2042 identify the record 
as the administrative record. The references to a hearing record in 
current paragraphs (d) and (g) may cause confusion when no hearing is 
conducted. To make the terminology consistent throughout the rules, 
account for decisions that are issued without a hearing being 
conducted, and minimize confusion, we are proposing to revise 
Sec. Sec.  405.1000(d) and 423.2000(d) so that a decision is based on 
the administrative record, including, for an ALJ, any hearing record, 
and Sec. Sec.  405.1000(g) and 423.2000(g) to provide that a decision 
is based on the administrative record.
    Current Sec.  405.1000(e) and (g) discuss two circumstances in 
which a decision on a request for hearing can be issued by an ALJ 
without conducting a hearing, either where the parties waive the 
hearing or where the record supports a fully favorable finding. Related 
to current Sec.  405.1000(e), current Sec.  405.1000(f) discusses the 
ALJ's authority to conduct a hearing even if the parties waive the 
hearing. As discussed in section III.A.3.r below, we are proposing to 
revise Sec.  405.1038 to modify the circumstances in which a decision 
on a request for hearing can be issued without conducting a hearing. As 
discussed in the proposed revisions to Sec.  405.1038, we would require 
that waivers be obtained by the parties entitled to a notice of hearing 
in accordance with Sec.  405.1020(c), or to require that the record 
supports a fully favorable finding for the appellant and there is no 
other party or no other party is entitled to a notice of hearing in 
accordance with Sec.  405.1020(c). Proposed Sec.  405.1000(e), (f), and 
(g) would be revised for consistency with the Sec.  405.1038 proposals 
and to accurately summarize when a decision on a request for hearing 
can be issued without conducting a hearing in accordance with proposed 
Sec.  405.1038. We are not proposing similar changes in Sec.  
423.2000(e), (f), and (g) because we are not proposing changes to when 
a decision on a request for hearing can be issued without conducting a 
hearing in Sec.  423.2038.
    Current Sec.  405.964(c) requires a QIC to consolidate requests for 
a reconsideration filed by different parties on the same claim before a 
reconsideration is made on the first timely filed request. While 
current Sec.  405.1044 permits an ALJ to consolidate requests for 
hearing if one or more of the issues to be considered at the hearing 
are the same issues that are involved in another request for hearing 
pending before the same ALJ, the provision is discretionary and 
dependent on the requests being

[[Page 43803]]

assigned to the same ALJ. To mitigate the potential of requests for 
hearing on the same claim filed by different parties being separately 
adjudicated, we are proposing to add Sec.  405.1000(h) to require that 
when more than one party files a timely request for hearing on the same 
claim before a decision is made on the first timely filed request, the 
requests are consolidated into one proceeding and record, and one 
decision, dismissal, or remand is issued. We note that if a decision 
was issued on the first timely request before an additional request is 
timely filed or good cause is found to extend the period to file the 
additional request for hearing, a reopening of the decision may be 
considered by the deciding adjudicator in accordance with Sec.  
405.980. For example, if a request is submitted with new and material 
evidence that was not available at the time of the decision and may 
result in a different conclusion, the reopening provisions at Sec.  
405.980 would apply. Because only the enrollee is a party in a part 
423, subpart U proceeding on a request for an ALJ hearing, no 
corresponding changes are proposed for Sec.  423.2000.
    We are inviting public comments on these proposals. If you choose 
to comment on the proposals in this section, please include the caption 
``Hearing before an ALJ and decision by an ALJ or attorney adjudicator 
general rule'' at the beginning of your comment.
b. Right to an ALJ Hearing (Sec. Sec.  405.1002 and 423.2002)
    Current Sec. Sec.  405.1002 and 423.2002 discuss a right to an ALJ 
hearing. Current Sec. Sec.  405.1002(a) and 423.2002(a) provide that a 
party to a QIC reconsideration or the enrollee who receives an IRE 
reconsideration, respectively, may ``request'' a hearing before an ALJ 
if the party or enrollee files a timely request and meets the amount in 
controversy requirement. However, a party or enrollee is entitled to a 
hearing only when those requirements are met. See sections 1860D-4(h) 
and 1869(b)(1)(A) of the Act. Therefore, we are proposing to revise 
Sec. Sec.  405.1002(a) and 423.2002(a) introductory text to state that 
the party to a QIC reconsideration or the enrollee who receives an IRE 
reconsideration has a right to a hearing rather than may request a 
hearing. These proposed changes would align the provisions with the 
statute and clarify that the party or enrollee has a right to a hearing 
before an ALJ when the criteria are met.
    Current Sec. Sec.  405.1002(a)(4) and 423.2002(e) provide that the 
request is considered filed on the date it is received by the entity 
specified in the QIC's or IRE's reconsideration. There has been 
confusion when a request is sent to an OMHA office that is not 
specified in the reconsideration, and this error causes delays in 
processing the request. We are proposing to revise Sec. Sec.  
405.1002(a)(4) and 423.2002(e) to replace ``entity'' with ``office'' to 
avoid confusion that the request may be filed with OMHA as an entity, 
and therefore any OMHA office, rather than the specific OMHA office 
identified in the QIC's or IRE's reconsideration. This would help 
ensure appellants are aware that a request for hearing must be filed 
with the office indicated in the notice of reconsideration to avoid 
delays. For example, when the notice of reconsideration indicates that 
a request for hearing must be filed with the OMHA central docketing 
office, an appellant will cause a delay if the request is sent to the 
QIC or IRE, or an OMHA field office. We also note that as explained in 
the 2009 Final Rule (74 FR 65319 through 65320), pursuant to current 
Sec.  405.1014(b)(2), if a request for hearing is timely filed with an 
entity other than the entity specified in the notice of 
reconsideration, the request is not treated as untimely or otherwise 
rejected. This would remain true for requests that are timely filed 
with an office other than the office specified in the notice of 
reconsideration, pursuant to proposed Sec.  405.1014(c)(2), which 
incorporates the requirement from current Sec.  405.1014(b)(2). This 
would also apply in part 423, subpart U adjudications because the same 
language appears in current Sec.  423.2014(c)(2) and is incorporated in 
proposed Sec.  423.2014(d)(2).
    Current Sec.  405.1002(b)(1) provides that when a party files a 
request with the QIC to escalate the appeal, it is escalated to ``the 
ALJ level.'' We are proposing to revise Sec.  405.1002(b)(1) to replace 
``to the ALJ level'' with ``for a hearing before an ALJ'' so that when 
a request for a QIC reconsideration is escalated, it is escalated ``for 
a hearing before an ALJ.'' This would help ensure that the right to a 
hearing is clear when an appeal is escalated from the QIC. There is no 
corresponding provision in part 423, subpart U.
    Current Sec.  423.2002(c) provides that the ALJ must document all 
oral requests for expedited hearings. However, an ALJ is not assigned 
to an appeal until after the request for hearing is received and 
processed. Thus, we are proposing to revise Sec.  423.2002(c) to state 
that ``OMHA'' must document all oral requests for expedited hearings. 
There is no corresponding provision in part 405, subpart I.
    We are inviting public comments on these proposals. If you choose 
to comment on the proposals in this section, please include the caption 
``Right to an ALJ hearing'' at the beginning of your comment.
c. Right to a Review of QIC or IRE Notice of Dismissal (Sec. Sec.  
405.1004 and 423.2004)
    Current Sec. Sec.  405.1004 and 423.2004 discuss the right to an 
ALJ review of a QIC notice of dismissal or IRE notice of dismissal, 
respectively. As proposed in section II.B above, attorney adjudicators 
or ALJs would conduct reviews of QIC or IRE dismissals. Accordingly, we 
are proposing to remove references to an ALJ in the titles of proposed 
Sec. Sec.  405.1004 and 423.2004, though ALJs would continue to have 
the authority to conduct reviews of QIC or IRE dismissals if a request 
for a review of a QIC or IRE dismissal is assigned to an ALJ. We also 
propose to insert ``or attorney adjudicator'' after ALJ in Sec. Sec.  
405.1004(a) introductory language, (b), (c); and 423.2004(a) 
introductory language, (b), and (c), to provide that an attorney 
adjudicator could review a QIC or IRE dismissal, as proposed in section 
II.B above. We also are proposing to replace the reference to 
``entity'' in current Sec. Sec.  405.1004(a)(4) and 423.2004(a)(4), 
with ``office,'' for the same reasons discussed above in III.A.3.b, for 
amending parallel language in Sec. Sec.  405.1002 and 423.2002.
    Current Sec. Sec.  405.1004(b) and 423.2004(b) provide that if an 
ALJ determines that the QIC's or IRE's dismissal was in error, he or 
she vacates the dismissal and remands the case to a QIC or IRE. As 
discussed in III.A.3.p below, we are proposing to revise the remand 
provisions and add new Sec. Sec.  405.1056 and 405.1058, 423.2056, and 
423.2058 to govern when remands may be issued, whether and to what 
extent remands may be reviewed, providing notice of a remand, and the 
effect of a remand. We are also proposing to revise Sec. Sec.  
405.1004(b) and 423.2004(b) to add references to proposed Sec. Sec.  
405.1056 and 423.2056, respectively, to explain that the remand would 
be in accordance with proposed Sec. Sec.  405.1056 and 423.2056, which 
as discussed in section III.A.3.p below, would address issuing remands 
and notices thereof, including for remands of QIC or IRE dismissals.
    Current Sec. Sec.  405.1004(c) and 423.2004(c) state that an ALJ's 
decision regarding a QIC's or IRE's dismissal of a reconsideration 
request is binding and not subject to further review, and that the 
dismissal of a request for ALJ review of a QIC's or IRE's dismissal of 
a

[[Page 43804]]

reconsideration request is binding and not subject to further review, 
unless vacated by the Council under Sec.  405.1108(h) or Sec.  
423.2108(b), respectively. In our experience, these sections as 
currently drafted have been a source of confusion for adjudicators and 
appellants. The two sentences convey different actions that can result 
from a request for review of a QIC or IRE dismissal--a decision 
regarding whether the QIC's or IRE's dismissal was correct, or a 
dismissal of the appellant's request for an ALJ review of the QIC's or 
IRE's dismissal. We are proposing to separate and further distinguish 
the two situations to avoid the current confusion that results from two 
of the three possible outcomes that may result from a request to review 
a QIC or IRE dismissal (the third being a remand of the dismissal, 
addressed in paragraph (b) in the respective sections) being in the 
same paragraph by proposing a separate paragraph for each outcome 
currently addressed in paragraph (c).
    We are proposing to revise Sec. Sec.  405.1004(c) and 423.2004(c) 
to include the possible outcome in the first sentence of current 
Sec. Sec.  405.1004(c) and 423.2004(c) of a decision affirming the 
QIC's or IRE's dismissal. We also are proposing to move language in 
current Sec. Sec.  405.1004(c) and 423.2004(c) stating that the 
decision of an ALJ on a request for review of a QIC dismissal is 
binding and not subject to further review, to proposed Sec. Sec.  
405.1048(b) and 423.2048(b), which as discussed in section III.A.3.v 
below, would address the effects of decisions on requests to review a 
QIC or IRE dismissal. In addition, we are proposing in Sec. Sec.  
405.1004(c) and 423.2004(c), respectively, to state that a decision 
affirming a QIC or IRE dismissal would be issued in accordance with 
proposed Sec. Sec.  405.1046(b) and 423.2046(b), which as discussed in 
section III.A.3.v below, would address issuing decisions on requests 
for review of a QIC or IRE dismissal and notices thereof.
    The 2009 Final Rule (74 FR 65311 through 65312) also explained that 
if a request for ALJ review of a QIC dismissal was invalid and thus 
subject to dismissal, the dismissal of the request to review a QIC 
dismissal was binding and not subject to further review (however, a 
party could request that the dismissal be vacated by the Council 
pursuant to Sec.  405.1108(b)). We are proposing to add Sec. Sec.  
405.1004(d) and 423.2004(d) to state that the ALJ or attorney 
adjudicator may dismiss a request for review of a QIC's or an IRE's 
dismissal in accordance with proposed Sec. Sec.  405.1052(b) or 
423.2052(b), respectively, which as discussed in section III.A.3.x 
below, would address dismissals of requests for review of a QIC or IRE 
dismissal and notices thereof. We also are proposing to move language 
in current Sec. Sec.  405.1004(c) and 423.2004(c) stating that the 
dismissal is binding and not subject to further review unless the 
dismissal is vacated, to proposed Sec. Sec.  405.1054(b) and 
423.2054(b), which would address the effects of a dismissal of a 
request for review of a QIC's or an IRE's dismissal and as discussed in 
section III.A.3.x below, would provide authority for an ALJ or attorney 
adjudicator to vacate a dismissal and therefore replace the current 
reference to the Council.
    We are inviting public comments on these proposals. If you choose 
to comment on the proposals in this section, please include the caption 
``Right to a review of QIC or IRE notice of dismissal'' at the 
beginning of your comment.
d. Amount in Controversy Required for an ALJ Hearing (Sec. Sec.  
405.1006, 405.976(b)(7), 423.1970, 422.600(b), and 478.44(a))
    Current Sec.  405.1006 sets forth the requirements for meeting the 
amount in controversy for an ALJ hearing. The title of current Sec.  
405.1006 states that the amount in controversy is required to 
``request'' an ALJ hearing and judicial review. However, as discussed 
in III.A.3.b above, section 1869(b)(1)(A) of the Act states that a 
party is entitled to a hearing before the Secretary and judicial 
review, subject to the amount in controversy and other requirements. To 
align the title of Sec.  405.1006 with the statutory provision, we are 
proposing that the amount in controversy is required ``for'' an ALJ 
hearing and judicial review rather than ``to request'' an ALJ hearing 
and judicial review. Put another way, a party may request an ALJ 
hearing or judicial review, albeit unsuccessfully, without satisfying 
the amount in controversy requirement.
    Section 1869(b)(1)(E) of the Act establishes the minimum amounts in 
controversy for a hearing by the Secretary and for judicial review, but 
does not establish how to calculate the amounts in controversy. Current 
Sec.  405.1006(d) states that the amount remaining in controversy is 
calculated based on the actual amount charged to the individual (a 
beneficiary) for the items or services in question (commonly referred 
to as billed charges), reduced by any Medicare payments already made or 
awarded for the items or services, and any deductible and coinsurance 
amounts applicable to the particular case. In an effort to align the 
amount in controversy with a better approximation of the amount at 
issue in an appeal, we are proposing to revise the basis (that is, the 
starting point before any deductions for any payments already made by 
Medicare or any coinsurance or deductible that may be collected) used 
to calculate the amount in controversy. For appeals of claims submitted 
by providers of services, physicians, and other suppliers that are 
priced based on a published Medicare fee schedule or published 
contractor priced amount (as discussed below), rather than using the 
actual amount charged to the individual as the basis for the amount in 
controversy, we are proposing to use the Medicare allowable amount for 
the items and/or services being appealed, subject to the exceptions 
discussed below. An allowable amount is the maximum amount of the 
billed charge deemed payable for the item or service. For the purposes 
of the amount in controversy under Sec.  405.1006, we are proposing at 
Sec.  405.1006(d)(2)(i)(A) that for items and services with a published 
Medicare fee schedule or published contractor-priced amount, the basis 
for the amount in controversy is the allowable amount, which would be 
the amount reflected on the fee schedule or in the contractor-priced 
amount for those items or services in the applicable jurisdiction and 
place of service.
    For a vast majority of items and services furnished and billed by 
physicians and other suppliers, allowable amounts are determined based 
on Medicare fee schedules. Fee schedules are updated and published on 
an annual basis by CMS through rulemaking, and CMS and its contractors 
have tools and resources available to inform physicians and other 
suppliers of allowable amounts based on these fee schedules, including 
the Physician Fee Schedule Look-up Tool available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PFSlookup/ and 
spreadsheets for other fee schedules that can be accessed on the CMS 
Web site through the fee schedule main page at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/FeeScheduleGenInfo/index.html. Allowable amounts for many contractor priced items and 
services are also included in these tools and resources. Allowable 
amounts are included on the Medicare remittance advice for paid items 
and services, but not for items and services that are denied. However, 
where the allowable amount for an item or service is determined based 
on a published fee schedule or contractor priced amount, we anticipate 
that appellants, other than beneficiaries who

[[Page 43805]]

are not represented by a provider, supplier, or Medicaid State agency, 
would be able to use the existing CMS and contractor tools and 
resources to determine allowable amounts for denied services when 
filing a request for hearing, and those amounts could be verified by 
OMHA in determining whether the claims included in the request meet the 
amount in controversy requirement. As discussed below, where the 
appellant is a beneficiary who is not represented by a provider, 
supplier, or Medicaid State agency, CMS would require the QIC to 
specify in the notice of reconsideration, for partially or fully 
unfavorable reconsideration decisions, whether the amount remaining in 
controversy is estimated to meet or not meet the amount required for an 
ALJ hearing under proposed Sec.  405.1006(d).
    Due to the pricing methodology for many items and services 
furnished by providers of services, such as hospitals, hospices, home 
health agencies, and skilled nursing facilities, at the present time an 
allowable amount is not easily discerned or verified with existing CMS 
and contractor pricing tools (for example, there is no pricing tool 
available for hospital outpatient services paid under the outpatient 
prospective payment system (OPPS)) for pre-payment claim denials (where 
items or services on the claim are denied, in full or in part, before 
claim payment has been made). Similarly, items and services furnished 
by providers or suppliers that are always non-covered, as well as 
unlisted procedures, may not have published allowable amounts based on 
a fee schedule or a published contractor-priced amount. Therefore, we 
are proposing at Sec.  405.1006(d)(2)(i)(B) to continue using the 
provider's or supplier's billed charges as the basis for calculating 
the amount in controversy for appeals of claims that are not priced 
according to a CMS-published fee schedule and do not have a published 
contractor-priced amount (except as discussed below). We note that the 
method for calculating the amount in controversy in this scenario would 
be the same as under current Sec.  405.1006(d), and we believe that all 
appellants have access to this information through claims billing 
histories, remittance advices, or the column titled ``Amount Provider 
[or Supplier] Charged'' on the Medicare Summary Notice. However, we are 
soliciting comment on whether existing tools and resources are 
available that would enable providers, suppliers, and Medicaid State 
agencies to submit an allowable amount in their request for hearing (as 
proposed in Section III.A.3.g.i below) for items and services not 
subject to published fee schedules or published contractor priced 
amounts, and whether those amounts could also be verified by OMHA. We 
are also soliciting comment on how such tools and resources could be 
used in appeals filed by beneficiaries.
    Current Sec.  405.1006(d)(1) introductory text uses ``the actual 
amount charged the individual for the items and services in question'' 
as the basis (starting point) for calculating the amount in 
controversy, before any reductions described in paragraphs (d)(1)(i) 
and (ii) (for any Medicare payments already made or awarded and any 
deductible and coinsurance applicable in the particular case) occur. 
For the reasons discussed above, we are proposing to revise paragraph 
(d)(1) introductory text to state that in situations other than those 
described in Sec.  405.1006(d)(3) through (7) (discussed below), the 
amount in controversy is computed as ``the basis for the amount in 
controversy for the items and services in the disputed claim as defined 
in paragraph (d)(2)'', less applicable reductions described in 
paragraphs (d)(1)(i) and (ii), and are proposing to revise paragraph 
(d)(2) to specify the amount that would be used as the basis for the 
amount in controversy on a situational basis. We are also proposing at 
Sec.  405.1006(d)(3) through (7) five exceptions to the general 
calculation methodology specified in proposed paragraphs (d)(1) and 
(2).
    There has also been confusion in calculating the amount in 
controversy when an appealed reconsideration involves multiple claims. 
Section 1869 of the Act and part 405, subpart I provide for an appeals 
process in which each claim decision is appealed and separately 
adjudicated. However, in some instances, claims are considered together 
based on an appellant's request. To address confusion with calculating 
the amount in controversy when reconsiderations involve multiple claims 
and to help ensure Sec.  405.1006 clearly conveys that the amount in 
controversy requirement must be met for each appealed claim unless the 
claim can be aggregated as discussed below, proposed Sec.  
405.1006(d)(1) would clarify that the amount in controversy is based on 
the items or services in the disputed ``claim.''
    We are proposing to maintain the current reduction to the 
calculation of the amount in controversy in Sec.  405.1006(d)(1)(i), 
which states that the basis for the amount in controversy is reduced by 
any Medicare payments already made or awarded for the items or 
services. In addition, current Sec.  405.1006(d)(1)(ii) provides that 
the basis for the amount in controversy is further reduced by ``[a]ny 
deductible and coinsurance amounts applicable in the particular case.'' 
We are proposing to revise Sec.  405.1006(d)(1)(ii) to read, ``Any 
deductible and/or coinsurance amounts that may be collected for the 
items or services.'' We believe revising this provision is appropriate 
to better align the amount at issue in the appeal and the amount in 
controversy so that in situations where a provider or supplier is 
prohibited from collecting applicable coinsurance and/or deductible, or 
must refund any such amounts already collected, the basis for the 
amount in controversy is not reduced by that amount (for example, if a 
provider or supplier is held liable for denied services under the 
limitation on liability provision in section 1879 of the Act, any 
amounts collected for the denied service, including coinsurance and/or 
deductible must be refunded).
    As discussed above, we are proposing at Sec.  405.1006(d)(2)(i) 
that, for situations other than those described in Sec.  
405.1006(d)(2)(ii) and (iii), the basis for calculating the amount in 
controversy under Sec.  405.1006(d)(1) would be the Medicare allowable 
amount, which is the amount reflected on the fee schedule or in the 
contractor-priced amount for those items or services in the applicable 
jurisdiction and place of service if there is a published Medicare fee 
schedule or published contractor-priced amount for the items or 
services in the disputed claim; or if there is no published Medicare 
fee schedule or contractor-priced amount for the items or services in 
the disputed claim, the basis for the amount in controversy would be 
the provider or supplier's billed charges submitted on the claim for 
the items and services. We believe providers, suppliers, and Medicaid 
State agencies would be able to utilize existing CMS and CMS contractor 
tools and resources to determine the allowable amount for items and 
services with published fee schedule or published contractor-priced 
amounts, and for items or services without a published fee schedule or 
published contractor priced amount, the calculation methodology for the 
amount in controversy would be the same as the calculation methodology 
specified in current Sec.  405.1006(d). However, there may be instances 
where a beneficiary would appeal a claim for items and services for 
which the allowable amount would be the basis for the amount in 
controversy under proposed Sec.  405.1006(d)(2)(i)(A) (for example, a 
claim for items or services with a published fee schedule or published

[[Page 43806]]

contractor-priced amount that does not involve an overpayment and for 
which the beneficiary has not been determined to be financially 
responsible). We believe most beneficiaries are not familiar with 
published fee schedule or contractor-priced amounts and may be unable 
to determine the amount in controversy in these circumstances with the 
resources currently available to them. However, as discussed below, we 
are proposing at Sec.  405.976(b)(7) that the QIC include in the notice 
of reconsideration a statement of whether the amount in controversy is 
estimated to meet or not meet the amount required for an ALJ hearing, 
if the request for reconsideration was filed by a beneficiary who is 
not represented by a provider, supplier, or Medicaid State agency, and 
the reconsideration is partially or fully unfavorable to the appellant. 
For appeals filed by beneficiaries, often the amount at issue is 
aligned not with the Medicare allowable amount, but rather with the 
billed charges of the provider or supplier. For example, where a 
beneficiary is held financially responsible for a denied claim under 
the limitation on liability provisions in section 1879 of the Act 
because he or she received an Advance Beneficiary Notice of Noncoverage 
(ABN), the beneficiary is responsible for the billed charges on the 
claim. Or, for a claim not submitted on an assignment-related basis 
that is denied, the beneficiary may be responsible for the billed 
charges, or the billed charges subject to the limiting charge in 
section 1848(g) of the Act. Medicare notifies the beneficiary of the 
amount he or she may be billed for denied services on the Medicare 
Summary Notice in a column titled, ``Maximum You May Be Billed.'' For 
appeals filed by a provider, supplier, or Medicaid State agency for 
denied items or services for which the beneficiary was determined to be 
financially responsible, we believe providers, suppliers, and Medicaid 
State agencies would have sufficient access to the provider or 
supplier's billing information and Medicare claims processing data to 
determine the amount charged to the beneficiary. Accordingly, we are 
proposing at Sec.  405.1006(d)(2)(ii) that for any items or services 
for which a beneficiary has been determined to be financially 
responsible, the basis for the amount in controversy is the actual 
amount charged to the beneficiary (or the maximum amount the 
beneficiary may be charged if no bill has been received) for the items 
or services in the disputed claim. As discussed above, this amount 
would be set forth on the Medicare Summary Notice in the column titled 
``Maximum You May Be Billed.''
    We are also proposing at Sec.  405.1006(d)(2)(iii) that if a 
beneficiary received or may be entitled to a refund of the amount the 
beneficiary previously paid to the provider or supplier for the items 
or services in the disputed claim under applicable statutory or 
regulatory authorities, the basis for the amount in controversy would 
be the actual amount originally charged to the beneficiary for the 
items or services in the disputed claim, as we believe that the amount 
originally charged to the beneficiary is more reflective of the actual 
amount at issue for the beneficiary and for the provider or supplier in 
this situation. We believe appellants would have access to and would 
use the same information for determining the basis for the amount in 
controversy under paragraph Sec.  405.1006(d)(2)(iii) as they would 
under Sec.  405.1006(d)(2)(ii).
    As discussed above, we are proposing at Sec.  405.1006(d)(3) 
through (7) five exceptions to the general methodology used to 
calculate the amount in controversy specified in Sec.  405.1006(d)(1). 
Current Sec.  405.1006(d)(2) provides that, notwithstanding current 
Sec.  405.1006(d)(1), when payment is made for items or services under 
section 1879 of the Act or Sec.  411.400, or the liability of the 
beneficiary for those services is limited under Sec.  411.402, the 
amount in controversy is computed as the amount that the beneficiary 
would have been charged for the items or services in question if those 
expenses were not paid under Sec.  411.400 or if that liability was not 
limited under Sec.  411.402, reduced by any deductible and coinsurance 
amounts applicable in the particular case. We are proposing to re-
designate current Sec.  405.1006(d)(2) as Sec.  405.1006(d)(3) and to 
revise the paragraph to state that when payment is made for items or 
services under section 1879 of the Act or Sec.  411.400, or the 
liability of the beneficiary for those services is limited under Sec.  
411.402, the amount in controversy would be calculated in accordance 
with Sec.  405.1006(d)(1) and (2)(i), except there is no deduction 
under paragraph (d)(1)(i) for expenses that are paid under Sec.  
411.400 or as a result of liability that is limited under Sec.  
411.402. For example, when a claim for items or service is denied under 
section 1862(a)(1)(A) of the Act because the items or services were not 
reasonable and necessary for the treatment of illness or injury or to 
improve the functioning of a malformed body member, Medicare payment 
may nonetheless be made under the limitation on liability provisions of 
Sec.  1879 of the Act if neither the provider/supplier nor the 
beneficiary knew, or could reasonably have been expected to know, that 
payment would not be made. In instances such as these, we are proposing 
that the amount in controversy would be calculated as if the items or 
services in the disputed claim were denied and no payment had been made 
under section 1879 of the Act. We believe this exception is appropriate 
because appellants may still wish to appeal findings of non-coverage 
related to items and services for which liability of the party was 
limited or payment was made under section 1879 of the Act or Sec.  
411.400 or for which the beneficiary was indemnified under Sec.  
411.402, but if these payments or indemnifications were deducted from 
the basis for the amount in controversy, the amount in controversy 
could be zero. As this exception relates only to whether deductions are 
made under Sec.  405.1006(d)(1)(i) for any Medicare payments already 
made or awarded for the items or service, and the amount in controversy 
would otherwise be calculated in accordance with proposed Sec.  
405.1006(d)(1) and (d)(2)(i), we believe appellants would have access 
to and would use the same information for determining the amount in 
controversy under Sec.  405.1006(d)(3) as they would under Sec.  
405.1006(d)(1) and (d)(2)(i).
    Current Sec.  405.1006 does not address calculating the amount in 
controversy for matters involving a provider or supplier termination of 
a Medicare-covered item or service when the beneficiary did not elect 
to continue receiving the item or service (for example, Sec.  
405.1206(g)(2) provides that if a beneficiary is dissatisfied with a 
QIO's determination on his or her discharge and is no longer an 
inpatient in a hospital, the determination is subject to the general 
claims appeal process). In this circumstance, items and services have 
not been furnished, and therefore, a claim has not been submitted. Yet 
the beneficiary may elect not to continue receiving items or services 
while appealing the provider or supplier termination due to potential 
financial responsibility for the items or services. While an amount in 
controversy cannot be assessed for a period of time during which no 
items or services were furnished, a beneficiary may assert a continuing 
need for the items or services based on his or her condition at the 
time an appeal is heard. To address this circumstance, we are proposing 
new Sec.  405.1006(d)(4), which would provide that when a matter 
involves a provider or supplier

[[Page 43807]]

termination of Medicare-covered items or services and the beneficiary 
did not elect to continue receiving the items or services that are 
disputed by a beneficiary, the amount in controversy is calculated as 
discussed above regarding proposed (d)(1) and (d)(2)(ii) (which 
addresses situations where the beneficiary is determined to be 
financially responsible), except that the basis for the amount in 
controversy and any deductible and coinsurance that may be collected 
for the items or services are calculated using the amount the 
beneficiary would have been charged if the beneficiary had received the 
items or services that the beneficiary asserts should be covered by 
Medicare based on the beneficiary's current condition at the time an 
appeal is heard, and Medicare payment was not made. This proposal would 
allow the beneficiary to pursue coverage for an item or service and 
potentially meet the amount in controversy requirement in instances in 
which he or she would not otherwise be able to pursue a hearing before 
an ALJ because no items or services have been rendered and therefore no 
amount in controversy exists because there is no disputed claim. In 
these instances, the beneficiary has been notified of a preliminary 
decision by a provider or supplier that Medicare will not cover 
continued provision of the items or services in dispute. Therefore, we 
believe using the amount the beneficiary would be charged if the 
beneficiary elected to continue receiving the items or services that 
the beneficiary asserts should be covered and if Medicare payment were 
not made for these items or services (in other words, the amount the 
beneficiary would be charged if the beneficiary were financially 
responsible for these items or services) is most reflective of the 
actual amount in dispute. Most beneficiary appeals of provider or 
supplier terminations of Medicare-covered items or services involve the 
termination of Part A services and, therefore, we expect it would be 
rare that the amount in controversy would be less than that required 
for an ALJ hearing. However, we expect that beneficiaries wishing to 
determine if the amount in controversy required for an ALJ hearing was 
met could obtain from the provider or supplier the amount the 
beneficiary would be charged if the beneficiary elected to continue 
receiving the items or services and Medicare payment were not made. In 
addition, as discussed below, we are proposing at Sec.  405.976(b)(7) 
that the QIC would include in its notice of reconsideration a statement 
of whether the amount in controversy is estimated to meet or not meet 
the amount required for an ALJ hearing, if the request for 
reconsideration was filed by a beneficiary who is not represented by a 
provider, supplier, or Medicaid State agency, and the reconsideration 
decision was partially or fully unfavorable.
    We considered using Medicare payable amounts for denied items and 
services as the basis for the amount in controversy calculation 
specified in proposed Sec.  405.1006(d)(1), as that would be a more 
precise estimate of the amount at issue in the appeal than either the 
Medicare allowable amount or the billed charges. Payable amounts would 
take into account payment rules related to the items and services 
furnished that may increase or decrease allowable amounts (for example, 
multiple surgery reductions, incentive payments, and competitive 
bidding payments). However, CMS systems do not currently calculate 
payable amounts for denied services, and undertaking major system 
changes would delay implementation and has been determined not to be 
cost effective. While payable amounts may be a better representation of 
the amount at issue in the appeal, we believe the Medicare allowable 
amount and the other amount in controversy calculations provided in 
proposed Sec.  405.1006(d) are appropriate and reliable estimates that 
align well with the amount at issue for claims for which a payable 
amount has not been calculated.
    However, for post-payment denials, or overpayments, a payable 
amount has been determined and would be the most reliable indicator of 
the amount actually at issue in the appeal. Therefore, we are proposing 
new Sec.  405.1006(d)(5) to state that, notwithstanding the calculation 
methodology in proposed paragraphs (d)(1) and (2), when a claim appeal 
involves an overpayment determination, the amount in controversy would 
be the amount of the overpayment specified in the demand letter. In a 
post-payment denial, the amount of the overpayment identified in the 
demand letter is readily available to appellants, and is the most 
accurate reflection of the amount actually at issue in the appeal. In 
addition, current Sec.  405.1006 does not address appeals that involve 
an estimated overpayment amount determined through the use of sampling 
and extrapolation. In this circumstance, the claims sampled to 
determine the estimated overpayment may not individually meet the 
amount in controversy requirement, but the estimated overpayment 
determined through the use of extrapolation may meet the amount in 
controversy requirement. To address this circumstance, we are also 
proposing in new Sec.  405.1006(d)(5) that when a matter involves an 
estimated overpayment amount determined through the use of sampling and 
extrapolation, the estimated overpayment as extrapolated to the entire 
statistical sampling universe is the amount in controversy. This 
proposal would provide appellants the opportunity to appeal claims that 
may not individually meet the amount in controversy requirement if such 
claims were part of the sample used in making an overpayment 
determination that does meet the amount in controversy requirement. 
Because the overpayment determination reflects the amount for which the 
appellant is financially responsible, we believe it would be 
appropriate to allow appellants to appeal individual claims in the 
sample that was used to determine the overpayment. Whether an appeal 
involves an individual overpayment or an estimated overpayment 
determined through the use of sampling and extrapolation, we believe 
appellants against whom an overpayment was assessed would need only to 
consult the demand letter they received in order to determine the 
amount in controversy. However, we expect there may be circumstances 
where a beneficiary wishes to appeal an overpayment that was assessed 
against a provider or supplier, and in these situations the beneficiary 
may not have a copy of the demand letter that was received by the 
provider or supplier. For this reason, and as discussed below, we are 
proposing at Sec.  405.976(b)(7) that the QIC would include in its 
notice of reconsideration a statement of whether the amount in 
controversy is estimated to meet or not meet the amount required for an 
ALJ hearing, if the request for reconsideration was filed by a 
beneficiary who is not represented by a provider, supplier, or Medicaid 
State agency, and the reconsideration decision was partially or fully 
unfavorable. We are also proposing new Sec.  405.1006(d)(6), which 
would provide that when a beneficiary files an appeal challenging only 
the computation of a coinsurance amount, or the amount of a remaining 
deductible applicable to the items or services in the disputed claim, 
the amount in controversy is the difference between the amount of the 
coinsurance or remaining deductible, as determined by the contractor, 
and the amount of the coinsurance or remaining deductible the 
beneficiary believes is correct. We believe this provision is 
appropriate in these instances because,

[[Page 43808]]

without this provision, the amount in controversy determined under the 
general calculation methodology in Sec.  405.1006(d)(1) would be zero 
for a paid claim. In addition, we believe that the calculation proposed 
at Sec.  405.1006(d)(6) would appropriately reflect the amount at issue 
for the beneficiary in these appeals where the computation of a 
coinsurance amount, or the amount of a remaining applicable deductible 
is challenged. We believe beneficiaries would have access to the 
coinsurance and/or deductible amounts determined by the contractor for 
the paid claim on the beneficiary's Medicare Summary Notice, in the 
column titled ``Maximum You May Be Billed,'' and would need only to 
subtract the amount of coinsurance and/or deductible the beneficiary 
believes he or she should have been charged in order to arrive at the 
amount in controversy. We expect it would be extremely rare for a non-
beneficiary appellant to file an appeal challenging the computation of 
a coinsurance amount or the amount of a remaining deductible.
    In addition, we are proposing new Sec.  405.1006(d)(7), which would 
provide that for appeals of claims where the allowable amount has been 
paid in full and the appellant is challenging only the validity of the 
allowable amount, as reflected in the published Medicare fee schedule 
or in the published contractor priced amount applicable to the items or 
services in the disputed claim, the amount in controversy is the 
difference between the amount the appellant argues should have been the 
allowable amount for the items or services in the disputed claim in the 
applicable jurisdiction and place of service, and the published 
allowable amount for the items or services. We believe this provision 
is appropriate in these instances because, without this provision, the 
amount in controversy determined under the general calculation 
methodology in Sec.  405.1006(d)(1) would be zero for such paid claims. 
In addition, we believe that the calculation proposed at Sec.  
405.1006(d)(7) would appropriately reflect the amount at issue for the 
appellant in these appeals. We believe that, generally, these types of 
appeals are filed by providers and suppliers who are already familiar 
with the allowable amount for the items or services in the disputed 
claim based on information obtained from published fee schedules or 
contractor-priced amounts. Further, we believe that a fee schedule or 
contractor price challenge filed by a beneficiary on a paid claim would 
be a very rare occurrence. However, as discussed below, in the event a 
beneficiary would want to file such an appeal, the beneficiary could 
obtain an estimate of the amount in controversy from the QIC 
reconsideration. As discussed further below, we are proposing at Sec.  
405.976(b)(7) that the QIC would include in its notice of 
reconsideration a statement of whether the amount in controversy is 
estimated to meet or not meet the amount required for an ALJ hearing, 
if the request for reconsideration was filed by a beneficiary who is 
not represented by a provider, supplier, or Medicaid State agency, and 
the reconsideration decision was partially or fully unfavorable.
    In the event that a reconsideration, or a redetermination if the 
appeal was escalated from the QIC without a reconsideration, involves 
multiple claims and some or all do not meet the amount in controversy 
requirement, section 1869 of the Act states that, in determining the 
amount in controversy, the Secretary, under regulations, shall allow 
two or more appeals to be aggregated if the appeals involve the 
delivery of similar or related services to the same individual by one 
or more providers or suppliers, or common issues of law and fact 
arising from services furnished to two or more individuals by one or 
more providers or suppliers. Under this authority, Sec.  405.1006(e) 
provides for aggregating claims to meet the amount in controversy 
requirement.
    The title of current Sec.  405.1006(e)(1) for aggregating claims 
when appealing a QIC reconsideration is phrased differently than the 
corresponding title for aggregating claims when escalating a request 
for a QIC reconsideration in current Sec.  405.1006(e)(2), which may 
cause confusion. We are proposing to revise the title to Sec.  
405.1006(e)(1) to ``Aggregating claims in appeals of QIC 
reconsiderations for an ALJ hearing'' so it clearly applies to 
aggregating claims in appeals of QIC reconsiderations, and is parallel 
to the phrasing used in the title of Sec.  405.1006(e)(2). The proposed 
titles of Sec.  405.1006(e)(1) and (e)(2), and proposed Sec.  
405.1006(e)(2)(ii) would also replace ``to the ALJ level'' with ``for 
an ALJ hearing'' to again highlight that the appeal of a QIC 
reconsideration or escalation of a request for a QIC reconsideration is 
for an ALJ hearing.
    Current Sec.  405.1006(e)(1)(ii) provides that to aggregate claims, 
the request for ALJ hearing must list all of the claims to be 
aggregated. This has caused confusion because some appellants read 
current Sec.  405.1006(e)(1)(ii) as allowing appeals of new claims to 
be aggregated with claims in previously filed appeals, provided the new 
request for hearing lists the claims involved in the previously filed 
appeals. However, current Sec.  405.1006(e)(2)(i), which applies to 
aggregating claims that are escalated from the QIC for a hearing before 
an ALJ, requires that the claims were pending before the QIC in 
conjunction with the same request for reconsideration. We note that in 
the context of a request for hearing, aggregating new claims with 
claims from previously filed requests could delay the adjudication of 
the requests and is inconsistent with the current rule for aggregating 
claims that are escalated from the QIC. To address these issues and 
bring consistency to the aggregation provisions, we are proposing to 
revise Sec.  405.1006(e)(1)(ii) to require the appellant(s) to request 
aggregation of the claims in the same request for ALJ hearing or in 
multiple requests for an ALJ hearing filed with the same request for 
aggregation. This would allow an individual or multiple appellants to 
file either one request for an ALJ hearing for multiple claims to be 
aggregated, or multiple requests for an ALJ hearing for the appealed 
claims when requesting aggregation, while requiring them to be filed 
together with the associated request for aggregation. We are also 
proposing in Sec.  405.1006(e)(1)(iii) and (e)(2)(iii) that an ALJ or 
attorney adjudicator may determine that the claims that a single 
appellant seeks to aggregate involve the delivery of similar or related 
services, or the claims that multiple appellants seek to aggregate 
involve common issues of law and fact, but only an ALJ may determine 
the claims that a single appellant seeks to aggregate do not involve 
the delivery of similar or related services, or the claims that 
multiple appellants seek to aggregate do not involve common issues of 
law and fact. We are proposing this because an attorney adjudicator 
adjudicating requests for an ALJ hearing when no hearing is conducted, 
as proposed in section II.B above, would not be permitted under this 
proposed rule to dismiss a request for an ALJ hearing due to procedural 
issues such as an invalid aggregation request. Because only an ALJ 
would be permitted to dismiss a request for an ALJ hearing because 
there is no right to a hearing, which includes not meeting the amount 
in controversy requirement for a hearing, in accordance with proposed 
Sec.  405.1052(a), an attorney adjudicator could not make a 
determination that the aggregation criteria were not met because that 
determination would result

[[Page 43809]]

in a dismissal of a request for an ALJ hearing.
    Current Sec.  405.976(b)(7) requires that the QIC notice of 
reconsideration contain a statement of whether the amount in 
controversy needed for an ALJ hearing is met when the reconsideration 
is partially or fully unfavorable. We are proposing to revise Sec.  
405.976(b)(7) to require that the QIC notice of reconsideration include 
a statement of whether the amount in controversy is estimated to meet 
or not meet the amount required for an ALJ hearing only if the request 
for reconsideration was filed by a beneficiary who is not represented 
by a provider, supplier, or Medicaid State agency, and the 
reconsideration is partially or fully unfavorable. In line with current 
practice, we are not proposing to require that the QIC indicate what it 
believes to be the exact amount in controversy, but rather only an 
estimate of whether it believes the amount in controversy is met, 
because we believe the ultimate responsibility for determining whether 
the amount in controversy required for an ALJ hearing is met lies with 
appellants, subject to verification by an ALJ or attorney adjudicator 
(though, as discussed in section II.B above, only an ALJ would be able 
to dismiss a request for hearing for failure to meet the amount in 
controversy required for an ALJ hearing). We believe that providers, 
suppliers, and Medicaid State agencies have the tools, resources, and 
payment information necessary to calculate the amount in controversy in 
accordance with Sec.  405.1006(d), and are familiar with the allowable 
amounts for the places of service in which they operate. Furthermore, 
applicable plans against whom a Medicare Secondary Payer overpayment is 
assessed would have access to the overpayment amount specified in the 
demand letter, which would be used to determine the amount in 
controversy under proposed Sec.  405.1006(d)(5). Thus, we do not 
believe it is necessary for the QICs to continue to provide this 
statement for providers, suppliers, applicable plans, Medicaid State 
agencies, or beneficiaries represented by providers, suppliers or 
Medicaid State agencies. Furthermore, as discussed in section 
III.A.3.g.i below, we are proposing that appellants, other than 
beneficiaries who are not represented by a provider, supplier, or 
Medicaid State agency, include the amount in controversy in their 
requests for hearing (unless the matter involves a provider or supplier 
termination of Medicare-covered items or services that is disputed by a 
beneficiary, and the beneficiary did not elect to continue receiving 
the items or services). As providers, suppliers, Medicaid State 
agencies, applicable plans, and beneficiaries represented by a 
provider, supplier, or Medicaid State agency would be responsible for 
calculating the amount in controversy and including it on the request 
for hearing as proposed in section III.A.3.g.i, we do not believe a 
statement by the QIC that indicates only whether the amount in 
controversy was or was not met adds significant value to such 
appellants. Furthermore, we expect that the Medicare allowable amount 
under proposed Sec.  405.1006(d)(2)(i)(A) would be the basis for the 
amount in controversy in the majority of Part B appeals filed by non-
beneficiary appellants. While QICs have access to the amount charged to 
an individual based on billed charges, the allowable amounts for claims 
vary based on where these items and services were furnished, and the 
applicable fee schedules and contractor-priced amounts, and continuing 
to require the QICs to include a statement whether the amount in 
controversy needed for an ALJ hearing is met in all instances in which 
the decision is partially or fully unfavorable to the appellant would 
require substantially more work by the QIC, and could delay 
reconsiderations and increase costs to the government.
    Although we are not proposing that beneficiaries who are not 
represented by a provider, supplier, or Medicaid State agency would 
need to include the amount in controversy on their requests for hearing 
(as discussed later in this preamble), we do believe there may be 
instances where a beneficiary would want to know if the amount in 
controversy meets the amount required for an ALJ hearing when deciding 
whether to file a request for hearing. We believe there may be 
instances where a beneficiary who is not represented by a provider, 
supplier, or Medicaid State agency may not currently have sufficient 
information to determine whether the amount in controversy required for 
an ALJ hearing is met under proposed Sec.  405.1006. For example, under 
proposed Sec.  405.1006(d)(2)(i)(A), for items and services with a 
published Medicare fee schedule or published contractor-priced amount 
(and for which the beneficiary was determined to be not financially 
responsible), the basis for the amount in controversy would generally 
be the allowable amount, which is the amount reflected on the fee 
schedule or in the contractor-priced amount for those items or services 
in the applicable jurisdiction and place of service. Beneficiaries not 
represented by a provider, supplier, or Medicaid State agency would not 
generally be expected to be familiar with fee schedule and contractor-
priced amounts, and we believe they may have difficulty determining 
whether the amount in controversy required for an ALJ hearing is met in 
these cases. We also believe beneficiaries not represented by a 
provider, supplier, or Medicaid State agency might be unable to 
determine the amount of an overpayment assessed against a provider or 
supplier for items or services furnished to the beneficiary for 
purposes of calculating the amount in controversy under proposed Sec.  
405.1006(d)(5), as the beneficiary might not have access to the demand 
letter received by the provider or supplier, and may no longer have 
access to the Medicare Summary Notice reflecting the original payment 
amount. Accordingly, because there are situations where such 
beneficiaries may not have sufficient information to determine the 
amount in controversy, we are proposing to revise Sec.  405.976(b)(7) 
to state that the QIC would include in its notice of reconsideration a 
statement of whether the amount in controversy is estimated to meet or 
not meet the amount required for an ALJ hearing, if the request for 
reconsideration was filed by a beneficiary who is not represented by a 
provider, supplier, or Medicaid State agency, and the reconsideration 
decision was partially or fully unfavorable.
    Current Sec.  423.1970 describes the amount in controversy 
requirement for part 423, subpart U proceedings. For the same reasons 
we are proposing to revise Sec.  405.1006(e)(1)(ii), we are proposing 
in Sec.  423.1970(c)(1)(ii) and (c)(2)(ii) to provide that a single 
enrollee's or multiple enrollees' request for aggregation, 
respectively, must be filed at the same time the request (or requests) 
for hearing for the appealed reconsiderations is filed. In addition, we 
are proposing to revise Sec.  423.1970(c)(1)(ii) and Sec.  
423.1970(c)(2)(ii) to state that the request for aggregation and 
requests for hearing must be filed within 60 calendar days after 
receipt of the notice of reconsideration for each reconsideration being 
appealed, unless the deadline is extended in accordance with Sec.  
423.2014(d). This will help ensure there is no confusion that the 
timely filing requirement applies to each of the requests for hearing 
filed with the request for aggregation. Because we are proposing to 
directly reference the 60 calendar day filing requirement under

[[Page 43810]]

Sec.  423.1972(b) and the possible extension of the filing requirement 
under Sec.  423.2014(d), we are also proposing to remove the current 
references in Sec.  423.1970(c)(1)(ii) and (c)(2)(ii) to the filing 
requirement in Sec.  423.1972(b). In addition, for the same reasons we 
are proposing to revise Sec.  405.1006(e)(1)(iii) and (e)(2)(iii), we 
are proposing in Sec.  423.1970(c)(1)(iii) and (c)(2)(iii) that an ALJ 
or attorney adjudicator may determine that the appeals that a single 
enrollee seeks to aggregate involve the delivery of prescription drugs 
to a single enrollee, or the appeals that multiple enrollees seek to 
aggregate involve the same prescription drugs, but only an ALJ may 
determine appeals that a single enrollee seeks to aggregate do not 
involve the delivery of prescription drugs to a single enrollee, or the 
appeals that multiple enrollees seek to aggregate do not involve the 
same prescription drugs. We are proposing to replace ``prescription'' 
in current Sec.  423.1970(c)(2)(iii) with ``prescription drugs'' in 
proposed Sec.  423.1970(c)(2)(iii) for consistency with current and 
proposed Sec.  423.1970(c)(1)(iii). Finally, we are also proposing to 
correct the spelling of ``prescription'' in current Sec.  
423.1970(c)(2)(iii).
    Current Sec.  422.600(b) provides that the amount in controversy 
for appeals of reconsidered determinations to an ALJ (under the Part C 
Medicare Advantage program), is computed in accordance with part 405. 
However, if the basis for the appeal is the MAO's refusal to provide 
services, current Sec.  422.600(c) provides that the projected value of 
those services are used to compute the amount in controversy. We are 
not proposing to revise these provisions because we believe the 
proposed revisions to Sec.  405.1006 described above encompass and have 
application to the scenarios appealed under part 422, subpart M. In 
particular, we note that as is the case under current Sec.  405.1006, 
if an enrollee received items or services and is financially 
responsible for payment because the MAO has refused to cover the item 
or services, the amount in controversy would be calculated using the 
billed charges as the basis for the amount in controversy, as provided 
in proposed Sec.  405.1006(d)(2)(ii). If the enrollee did not receive 
the items or services, the provisions of current Sec.  422.600(c) would 
apply. We also note that current Sec. Sec.  422.622(g)(2) and 
422.626(g)(3) provides for an appeal to an ALJ, the Council, or federal 
court of an IRE's affirmation of a termination of provider services 
``as provided for under [part 422, subpart M],'' thus triggering the 
amount in controversy rules in 422.600, which cross-reference part 405 
(that is, the rules proposed here). Proposed Sec.  405.1006 would 
address scenarios appealed under part 422, subpart M that are not 
clearly addressed in current Sec.  405.1006, such as provider service 
terminations, which would be addressed in proposed Sec.  
405.1006(d)(4), and coinsurance and deductible challenges, which would 
be addressed in proposed Sec.  405.1006(d)(6).
    Current Sec.  478.44(a) also references back to part 405 provisions 
for determining the amount in controversy when requesting an ALJ 
hearing after a QIO reconsidered determination. We have proposed 
revisions to Sec.  478.44 in section III.D.3, below, to update part 405 
references, but we are not proposing in Sec.  478.44 to revise how the 
current or proposed part 405 provision would be applied in calculating 
the amount in controversy. Similar to the part 422, subpart M 
provisions discussed above, we believe the proposed revisions to Sec.  
405.1006 described above encompass and have application to the 
scenarios appealed under part 478, subpart B.
    We are inviting public comments on these proposals. If you choose 
to comment on issues in this section, please include the caption 
``Amount in controversy required for an ALJ hearing'' at the beginning 
of your comment.
e. Parties to an ALJ Hearing (Sec. Sec.  405.1008 and 423.2008)
    Current Sec. Sec.  405.1008 and 423.2008 discuss the parties to an 
ALJ hearing. Because current Sec. Sec.  405.1002(a) and 423.2002(a) 
already address who may request a hearing before an ALJ after a QIC or 
IRE issues a reconsideration and current Sec.  405.1002(b) addresses 
who may request escalation of a request for a QIC reconsideration, we 
are proposing to remove current Sec. Sec.  405.1008(a) and 423.2008(a).
    We are proposing to retain and revise the language as discussed 
below in current Sec. Sec.  405.1008(b) and 423.2008(b), but remove the 
paragraph designation. Current Sec. Sec.  405.1008(b) and 423.2008(b) 
identify the parties ``to the ALJ hearing,'' but this could be read to 
be limited to parties to an oral hearing, if a hearing is conducted. To 
address this potential confusion, we are proposing to revise Sec. Sec.  
405.1008 and 423.2008 to replace ``parties to an ALJ hearing'' with 
``parties to the proceedings on a request for an ALJ hearing'' and 
``party to the ALJ hearing'' with ``party to the proceedings on a 
request for an ALJ hearing.'' Likewise, we also are proposing to revise 
the titles to Sec. Sec.  405.1008 and 423.2008 from ``Parties to an ALJ 
hearing'' to ``Parties to the proceedings on a request for an ALJ 
hearing.''
    We are inviting public comments on these proposals. If you choose 
to comment the proposals in this section, please include the caption 
``Parties to an ALJ hearing'' at the beginning of your comment.
f. CMS and CMS Contractors as Participants or Parties in the 
Adjudication Process (Sec. Sec.  405.1010, 405.1012, and 423.2010)
    Consistent with section 1869(c)(3)(J) of the Act, Sec. Sec.  
405.1010 and 405.1012 allow CMS and its contractors to elect to be a 
participant or a party to a Part A or Part B hearing before an ALJ. 
Current Sec.  423.1010 allows CMS, a Part D plan sponsor, or an IRE to 
request to be a participant in the proceedings of a Part D hearing 
before an ALJ. Since current Sec. Sec.  405.1010, 405.1012, and 
423.2010 were added, CMS and its contractors, including the Part D IRE, 
and Part D plan sponsors, have assisted the ALJ hearing process by 
clarifying factual and policy issues, which provides ALJs with more 
information to resolve the issues on appeals. However, as we have 
gained experience with CMS and these entities as participants and 
parties to hearings, we have heard from ALJs and stakeholders that 
additional parameters are needed to help ensure hearings with the 
entities are as efficient as possible; expectations and roles are 
clear; and the entities have an opportunity to assist with appeals for 
which no hearing is conducted.
    Therefore, we are proposing significant revisions to Sec. Sec.  
405.1010, 405.1012, and 423.2010 to achieve these objectives.
    Proposed Sec. Sec.  405.1010 (When CMS or its contractors may 
participate in the proceedings on a request for an ALJ hearing), 
405.1012 (When CMS or its contractors may be a party to a hearing), and 
423.2010 (When CMS, the IRE, or Part D plan sponsor may participate in 
the proceedings on a request for an ALJ hearing) would be reorganized 
and aligned for clarity, and revised to improve the participation 
process. The proposed revised sections would be similarly structured to 
address when an entity may elect or request to participate in the 
proceedings on a request for an ALJ hearing, or be a party to a 
hearing; how elections or requests are made; the roles and 
responsibilities of CMS and its contractors; limitations on hearing 
participation; and invalid elections or requests.

[[Page 43811]]

i. Section 405.1010: When CMS or Its Contractors May Participate in the 
Proceedings on a Request for an ALJ Hearing
    Current Sec.  405.1010(a) provides that an ALJ may request, but may 
not require, CMS and/or its contractors to participate in any 
proceedings before the ALJ, including the oral hearing, if any, and CMS 
or its contractors may elect to participate in the hearing process. 
Under current Sec.  405.1010(b), if that election is made, CMS or its 
contractor must advise the ALJ, the appellant, and all other parties 
identified in the notice of hearing of its intent to participate no 
later than 10 calendar days after receiving the notice of hearing. 
Section 405.1010(c) sets forth what participation includes and Sec.  
405.1010(d) states that participation does not include CMS or its 
contractor being called as a witness during the hearing. Section 
405.1010(e) requires CMS or its contractors to submit any position 
papers within the time frame designated by the ALJ. Finally, Sec.  
405.1010(f) states that the ALJ cannot draw any adverse inferences if 
CMS or a contractor decides not to participate in any proceedings 
before an ALJ, including the hearing.
    The reference to the period in which an election to participate 
must be filed beginning upon receipt of the notice of hearing in 
current Sec.  405.1010(b) has caused confusion when CMS or its 
contractors attempt to enter proceedings before a hearing is scheduled, 
or when no notice of hearing is necessary because an appeal may be 
decided on the record. To help ensure that CMS and its contractors have 
the opportunity to enter the proceedings with minimal disruption to the 
adjudication process prior to a hearing being scheduled or when a 
hearing may not be conducted, we are proposing in Sec.  405.1010(a)(1) 
to provide that CMS or its contractors may elect to participate in the 
proceedings on a request for an ALJ hearing upon filing a notice of 
intent to participate in accordance with paragraph (b), at either of, 
but not later than, two distinct points in the adjudication process 
described in paragraph (b)(3).
    As provided in current Sec.  405.1010(a) and (f), we are proposing 
at Sec.  405.1010(a)(2) that an ALJ may request but may not require CMS 
and/or one or more of its contractors to participate in any proceedings 
before the ALJ, including the oral hearing, if any; and the ALJ cannot 
draw any adverse inferences if CMS or the contractor decides not to 
participate in the proceedings.
    We are proposing in Sec.  405.1010(b) to address how CMS or a 
contractor makes an election to participate in an appeal, before or 
after receipt of a notice of hearing or when a notice of hearing is not 
required. Under proposed Sec.  405.1010(b)(1), we are proposing that if 
CMS or a contractor elects to participate before receipt of a notice of 
hearing (such as during the 30 calendar day period after being notified 
that a request for hearing was filed as proposed in Sec.  
405.1010(b)(3)(i)) or when a notice of hearing is not required, CMS or 
the contractor must send written notice of its intent to participate to 
the parties who were sent a copy of the notice of reconsideration, and 
to the assigned ALJ or attorney adjudicator, as proposed in section 
II.B above, or if the appeal is not yet assigned, to a designee of the 
Chief ALJ. Proposed Sec.  405.1010(b)(1) would provide for sending the 
written notice of intent to participate to an ALJ or attorney 
adjudicator assigned to an appeal because, as we discuss in proposed in 
section II.B, an attorney adjudicator also would have the authority to 
issue decisions on a request for an ALJ hearing when no hearing is 
conducted, and in accordance with proposed Sec.  405.1010, CMS or its 
contractors are permitted to participate in the proceedings on such a 
request. Proposed Sec.  405.1010(b)(1) would also provide for sending 
the notice of intent to participate to a designee of the Chief ALJ if a 
request for an ALJ hearing is not yet assigned to an ALJ or attorney 
adjudicator because CMS or a contractor could file an election to be a 
participant in the proceedings before the assignment process is 
complete. Proposed Sec.  405.1010(b)(1) would help ensure that the 
potential parties to a hearing, if a hearing is conducted, would 
receive notice of the intent to participate, and also help ensure that 
adjudicators who are assigned to an appeal after an election is made 
would be aware of the election. Because only an ALJ may conduct a 
hearing and the parties to whom a notice of hearing is sent may differ 
from the parties who were sent a copy on the notice of reconsideration, 
we are proposing at Sec.  405.1010(b)(2) that if CMS or a contractor 
elects to participate after receiving a notice of hearing, CMS or the 
contractor would send written notice of its intent to participate to 
the ALJ and the parties who were sent a copy of the notice of hearing.
    Under proposed Sec.  405.1010(b)(3)(i), CMS or a contractor would 
have an initial opportunity to elect to be a participant in an appeal 
within 30 calendar days after notification that a request for hearing 
has been filed with OMHA, if no hearing is scheduled. CMS and its 
contractors have the capability to see that a QIC reconsideration had 
been appealed to OMHA in the case management system used by QICs. This 
system would provide constructive notice to the QICs when the system 
indicates an appeal has been filed with OMHA, which OMHA can monitor 
through the date that the reconsideration data is transferred to OMHA 
to adjudicate the request for an ALJ hearing. Under proposed Sec.  
405.1010(b)(3)(ii), a second opportunity to elect to be a participant 
in an appeal would become available if a hearing is scheduled; as in 
the current rule, CMS or a contractor would have 10 calendar days after 
receiving the notice of hearing to make the election.
    We considered allowing CMS or a contractor to make an election at 
any time prior to a decision being issued if a hearing was not 
scheduled, or sending a notice that a decision would be issued without 
a hearing and establishing an election period after such notice. 
However, both of these options would disrupt and delay the adjudication 
process, as well as add administrative burdens on OMHA. We believe the 
30 calendar day period after notification that a request for hearing 
was filed is sufficient time for CMS or a contractor to determine 
whether to elect to be a participant in the appeal while the record is 
reviewed for case development and to prepare for the hearing, or 
determine whether a decision may be appropriate based on the record in 
accordance with Sec.  405.1038.
    We are proposing to consolidate current Sec.  405.1010(c) through 
(e) in proposed Sec.  405.1010(c) to address the roles and 
responsibilities of CMS or a contractor as a participant. Proposed 
Sec.  405.1010(c)(1) would incorporate current Sec.  405.1010(c), which 
provides that participation may include filing position papers or 
providing testimony to clarify factual or policy issues, but it does 
not include calling witnesses or cross-examining a party's witnesses. 
However, we are proposing to revise Sec.  405.1010(c) to state in Sec.  
405.1010(c)(1) that participation may include filing position papers 
``and/or'' providing testimony to emphasize that either or both may be 
done, and to state that participation would be subject to proposed 
Sec.  405.1010(d)(1) through (3) (discussed below). We are proposing to 
incorporate current Sec.  405.1010(d) in proposed Sec.  405.1010(c)(2) 
to provide that when CMS or a contractor participates in a hearing, 
they may not be called as witnesses and, thus, are not

[[Page 43812]]

subject to examination or cross-examination by parties to the hearing. 
However, to be clear about how a party and the ALJ may address 
statements made by CMS or a contractor during the hearing given that 
limitation, we also are proposing in Sec.  405.1010(c)(2) that the 
parties may provide testimony to rebut factual or policy statements 
made by the participant, and the ALJ may question the participant about 
the testimony.
    We are proposing to incorporate current Sec.  405.1010(e) in 
proposed Sec.  405.1010(c)(3) with certain revisions as discussed 
below. Current Sec.  405.1010(e) states that CMS or its contractor must 
submit any position papers within the time frame designated by the ALJ. 
We are proposing in Sec.  405.1010(c)(3) to include written testimony 
in the provision, establish deadlines for submission of position papers 
and written testimony that reflect the changes in participation 
elections in proposed 405.1010(b), and require that copies of position 
papers and written testimony be sent to the parties. Specifically, we 
are proposing in Sec.  405.1010(c)(3)(i) that CMS or a contractor 
position paper or written testimony must be submitted within 14 
calendar days of an election to participate if no hearing has been 
scheduled, or no later than 5 calendar days prior to the scheduled 
hearing unless additional time is granted by the ALJ. We are proposing 
to add ``written testimony'' to recognize that CMS or a contractor may 
submit written testimony as a participant, in addition to providing 
oral testimony at a hearing. We are proposing to require position 
papers and written testimony be submitted within 14 calendar days after 
an election if no hearing is scheduled to help ensure the position 
paper and/or written testimony are available when determinations are 
made to schedule a hearing or issue a decision based on the record in 
accordance with Sec.  405.1038. We also are proposing to require that 
if a hearing is scheduled, position papers and written testimony be 
submitted no later than 5 calendar days prior to the hearing (unless 
the ALJ grants additional time) to help ensure the ALJ and the parties 
have an opportunity to review the materials prior to the hearing. 
Additionally, under proposed Sec.  405.1010(c)(3)(ii), CMS or a 
contractor would need to send a copy of any position paper or written 
testimony submitted to OMHA to the parties who were sent a copy of the 
notice of reconsideration if the position paper or written testimony is 
submitted to OMHA before receipt of a notice of hearing, or to the 
parties who were sent a copy of the notice of hearing if the position 
paper or written testimony is submitted after receipt of a notice of 
hearing. Current Sec.  405.1010 does not address the repercussions of a 
position paper not being submitted in accordance with the section. 
Therefore, we are proposing in Sec.  405.1010(c)(3)(iii) that a 
position paper or written testimony would not be considered in deciding 
an appeal if CMS or a contractor fails to send a copy of its position 
paper or written testimony to the parties, or fails to submit its 
position paper or written testimony within the established time frames. 
This would help ensure CMS or contractor position papers and written 
testimony are submitted timely and shared with the parties.
    Current Sec. Sec.  405.1010 does not limit the number of entities 
that may elect to be participants, which currently includes 
participating in a hearing if a hearing is conducted, and current Sec.  
405.1012 does not limit the number of entities that may elect to be a 
party to a hearing. This has resulted in hearings for some appeals 
being difficult to schedule and taking longer to conduct due to 
multiple elections. To address these issues, we are proposing at Sec.  
405.1010(d)(1) that when CMS or a contractor has been made a party to 
the hearing under Sec.  405.1012, CMS or a contractor that elected to 
be a participant under Sec.  405.1010 may not participate in the oral 
hearing, but may file a position paper and/or written testimony to 
clarify factual or policy issues in the case (oral testimony and 
attendance at the hearing would not be permitted). Similarly, we are 
proposing at Sec.  405.1010(d)(1) that CMS or a contractor that elected 
to be a party to the hearing, but was made a participant under Sec.  
405.1012(d)(1), as discussed below, would also be precluded from 
participating in the oral hearing, but would be permitted to file a 
position paper and/or oral testimony to clarify factual or policy 
issues in the case. We are proposing at Sec.  405.1010(d)(2) that if 
CMS or a contractor did not elect to be a party to the hearing under 
Sec.  405.1012, but more than one entity elected to be a participant 
under Sec.  405.1010, only the first entity to file a response to the 
notice of hearing as provided under Sec.  405.1020(c) may participate 
in the oral hearing, but additional entities that filed a subsequent 
response to the notice of hearing could file a position paper and/or 
written testimony to clarify factual or policy issues in the case 
(though they would not be permitted to attend the hearing or provide 
oral testimony). We are proposing that the first entity to file a 
response to the notice of hearing as provided under Sec.  405.1020(c) 
may participate in the hearing for administrative efficiency. Under 
this approach, if multiple entities elected to participate in the 
proceedings prior to the issuance of a notice of hearing, in accordance 
with proposed Sec.  405.1010(b)(1), any of these entities wishing to 
participate in the oral hearing would need to indicate this intention 
in the response to the notice of hearing. If more than one entity 
indicated its intention to attend and participate in the oral hearing, 
only the first entity to file its response would be permitted to do so. 
The remaining entities would be permitted only to file a position paper 
and/or written testimony (unless the ALJ grants leave to additional 
entities to attend the hearing, as discussed below). We considered an 
alternate proposal of the first entity that made an election to 
participate being given priority for participating in the hearing, but 
believe that would result in other participants being uncertain whether 
they will be participating in the hearing until as few as 5 days prior 
to the hearing. We also considered a process in which the ALJ would 
assess which participant that responded to the notice of hearing would 
be most helpful to the ALJ at the hearing, or in the alternative, 
permitting all participants to be at the hearing unless the ALJ 
determined a participant is not necessary for the hearing, but both of 
these approaches would add administrative burden to the ALJ and could 
result in participants and parties being uncertain of which 
participants will be at the hearing until shortly before the hearing. 
We welcome comments on the alternatives considered above, and other 
potential alternatives.
    Notwithstanding the limitations on CMS and CMS contractor 
participation in proposed Sec.  405.1010(d)(1) and (2), proposed Sec.  
405.1010(d)(3) would provide the ALJ with the necessary discretion to 
allow additional participation in the oral hearing when the ALJ 
determines an entity's participation is necessary for a full 
examination of the matters at issue. For example, if an appeal involves 
LCDs from multiple MAC jurisdictions, the ALJ may determine that 
allowing additional MACs to participate in a hearing is necessary for a 
full examination of the matters at issue. Similarly, if an overpayment 
determined through the use of a statistical sample and extrapolation is 
at issue, the ALJ may determine that

[[Page 43813]]

allowing the contractor that conducted the sampling to participate in 
the hearing is necessary to address issues related to the sampling and 
extrapolation, in addition to another contractor that made an election 
to clarify the policy and factual issues related to the merits of 
claims in the sample.
    Currently, there are no provisions in Sec.  405.1010 to address the 
possibility of CMS or a contractor making an invalid election. We are 
proposing to revise Sec.  405.1010(e) to add new provisions to 
establish criteria for when an election may be deemed invalid and 
provide standards for notifying the entity and the parties when an 
election is deemed invalid. Proposed Sec.  405.1010(e)(1) would provide 
that an ALJ or attorney adjudicator may determine an election is 
invalid if the election was not timely filed or the election was not 
sent to the correct parties. This would help ensure that CMS and its 
contractors make timely elections and inform parties of elections. To 
provide notice to the entity and the parties that an election was 
deemed invalid, proposed Sec.  405.1010(e)(2) would require a written 
notice of an invalid election be sent to the entity that submitted the 
election and the parties who are entitled to receive notice of the 
election. If no hearing is scheduled for the appeal or the election was 
submitted after the hearing occurred, proposed Sec.  405.1010(e)(2)(i) 
would provide that the notice of an invalid election be sent no later 
than the date the decision, dismissal, or remand notice is mailed. If a 
hearing is scheduled for the appeal, proposed Sec.  405.1010(e)(2)(ii) 
would provide that the written notice of an invalid election is sent 
prior to the hearing, and that if the notice would be sent fewer than 5 
calendar days before the hearing is scheduled to occur, oral notice 
must be provided to the entity, and the written notice must be sent as 
soon as possible after the oral notice is provided.
    We are inviting public comments on these proposals. If you choose 
to comment on the proposals in this section, please include the caption 
``Section 405.1010: When CMS or its contractors may participate in the 
proceedings on a request for an ALJ hearing'' at the beginning of your 
comment.
ii. Section 423.2010: When CMS, the IRE, or Part D Plan Sponsors May 
Participate in the Proceedings on a Request for an ALJ Hearing
    Current Sec.  423.2010 is similar to current Sec.  405.1010, except 
that CMS, the IRE, or the Part D plan sponsor may only request to 
participate, and the time periods to request to participate are shorter 
than the time periods to elect to participate under Sec.  405.1010, 
which provides the ALJ with time to consider the request to participate 
and make a determination on whether to allow participation by the 
entity. In addition, current Sec.  423.2010 addresses participation in 
Part D expedited appeals. Like proposed Sec.  405.1010(a), we are 
proposing at Sec.  423.2010(a) to provide CMS, the IRE, and the Part D 
plan sponsor with an opportunity to participate in the proceedings on a 
request for an ALJ hearing at two distinct points in the adjudication 
process, but the current policy of requiring the entity to request to 
participate is maintained. We are proposing at Sec.  423.2010(b)(3)(i) 
and (ii) that, if no hearing is scheduled, CMS, the IRE and/or the Part 
D plan sponsor would have an initial opportunity to request to be a 
participant in an appeal within 30 calendar days after notification 
that a standard request for hearing was filed with OMHA, or within 2 
calendar days after notification that a request for an expedited 
hearing was filed. The initial 30 calendar day period after 
notification that a standard request for hearing was filed with OMHA 
would be the same time frame provided under Sec.  405.1010 for initial 
CMS and contractor elections, and we believe that 30 calendar day 
period after notification that a request for hearing was filed is 
sufficient time for CMS, the IRE, and the Part D plan sponsor to 
determine whether to request to be a participant in the proceedings and 
for the request to be considered and granted or denied as the case is 
reviewed to determine whether a decision may be appropriate based on 
the record in accordance with Sec.  423.2038. We believe the 2 calendar 
day period after notification that an expedited request for hearing was 
filed is a reasonable period of time for CMS, the IRE, or the Part D 
plan sponsor to determine whether to request to be a participant in the 
proceedings given the 10-day adjudication time frame. We are proposing 
at Sec.  423.2010(b)(3)(iii) and (iv) to provide a second opportunity 
to request to be a participant in an appeal if a hearing is scheduled. 
We are proposing at Sec.  423.2010(b)(3)(iii) that if a non-expedited 
hearing is scheduled, CMS, the IRE, or the Part D plan sponsor would 
continue to have 5 calendar days after receiving the notice of hearing 
to make the request. We are proposing at Sec.  423.2010(b)(3)(iv) that 
if an expedited hearing is scheduled, CMS, the IRE, or the Part D plan 
sponsor would continue to have 1 calendar day after receiving the 
notice of hearing to make the request. These time frames are carried 
over from current Sec.  423.2010(b)(1) and (b)(3), and provide the ALJ 
with time to consider the request and notify the entity of his or her 
decision on the request to participate. As provided in current Sec.  
423.2010(a) and (g), we are proposing at Sec.  423.2010(a)(2) to 
provide that an ALJ may request but may not require CMS, the IRE, or 
the Part D plan sponsor to participate in any proceedings before the 
ALJ, including the oral hearing, if any, and that the ALJ may not draw 
any adverse inferences if CMS, the IRE, or the Part D plan sponsor 
declines to be a participant to the proceedings.
    The standards governing how an election is made in proposed Sec.  
405.1010(b) would be adopted in proposed Sec.  423.2010(b) governing 
how a request to participate is made, except that an oral request to 
participate could be made for an expedited hearing, and OMHA would 
notify the enrollee of the request to participate in such cases.
    Current Sec.  423.2010(b)(2) and (b)(4) provide that an ALJ will 
notify an entity requesting to participate of the decision on the 
request within 5 calendar days for a request related to a non-expedited 
hearing, or 1 calendar day for a request related to an expedited 
hearing. These time frames would be incorporated in proposed Sec.  
423.2020(c). In addition, proposed Sec.  423.2020(c)(1) would provide 
that if no hearing is scheduled, the notification is made at least 20 
calendar days before the ALJ or attorney adjudicator (as proposed in 
section II.B above) issues a decision, dismissal, or remand. This would 
provide the participant with time to submit a position paper in 
accordance with proposed Sec.  423.2010(d)(3)(i), as discussed below. 
Current Sec.  423.2010(c) would also be incorporated into proposed 
Sec.  423.2010(c), so that the provision clearly states that the 
assigned ALJ or attorney adjudicator (as proposed in section II.B 
above) has discretion to not allow CMS, the IRE, or the Part D plan 
sponsor to participate. Proposed Sec.  423.2010(c) would provide that 
an attorney adjudicator as well as the ALJ may make a decision on a 
request to participate because a request to participate may be 
submitted for appeals that may be assigned to an attorney adjudicator 
and those appeals could also benefit from CMS, the IRE, or the Part D 
plan sponsor participation in the proceedings. We are not proposing to 
limit the number of participants in a hearing similar to proposed Sec.  
405.1010(d) because the ALJ has the discretion to deny a request to 
participate under Sec.  423.1010 and may

[[Page 43814]]

therefore deny a request to participate if the ALJ determines that a 
hearing would have sufficient participant involvement or does not need 
participant involvement.
    We are proposing at Sec.  423.2010(d) to consolidate current Sec.  
423.2010(d) through (f), to address the roles and responsibilities of 
CMS, the IRE, or the Part D plan sponsor as a participant. 
Specifically, we are proposing at Sec.  423.2010(d)(1) to generally 
incorporate current Sec.  423.2010(d), which provides that 
participation may include filing position papers or providing testimony 
to clarify factual or policy issues, but it does not include calling 
witnesses or cross-examining a party's witnesses. However, we are 
proposing in Sec.  423.2010(d)(1) that participation may include filing 
position papers ``and/or'' providing testimony to emphasize that either 
or both may be done, and to remove the limitation that testimony must 
be written because participation may include providing oral testimony 
during the hearing. We are proposing at Sec.  423.2010(d)(2) to 
incorporate current Sec.  423.2010(e), which provides that when 
participating in a hearing, CMS, the IRE, or the Part D plan sponsor 
may not be called as a witness during the hearing and, thus, are not 
subject to examination or cross-examination by the enrollee at the 
hearing. However, to be clear about how an enrollee and the ALJ may 
address statements made by CMS, the IRE, or the Part D plan sponsor 
during the hearing given that limitation, we also are proposing in 
Sec.  423.2010(d)(2) that the enrollee may rebut factual or policy 
statements made by the participant, and the ALJ may question the 
participant about its testimony.
    We are proposing at Sec.  423.2010(d)(3) to incorporate current 
Sec.  423.2010(f) with certain revisions as discussed below. Current 
Sec.  423.2010(f) states that CMS, the IRE, and/or the Part D plan 
sponsor must submit any position papers within the time frame 
designated by the ALJ. We are proposing in Sec.  423.2010(d)(3) to 
include written testimony in the provision, establish deadlines for 
submission of position papers and written testimony that reflect the 
changes in participation elections in proposed 423.2010(b), and require 
that copies of position papers and written testimony be sent to the 
enrollee. Specifically, we are proposing in Sec.  423.2010(d)(3) that, 
unless the ALJ or attorney adjudicator grants additional time to submit 
a position paper or written testimony, a CMS, the IRE, or the Part D 
plan sponsor position paper or written testimony must be submitted 
within 14 calendar days for a standard appeal or 1 calendar day for an 
expedited appeal after receipt of the ALJ's or attorney adjudicator's 
decision on a request to participate if no hearing has been scheduled, 
or no later than 5 calendar days prior to a non-expedited hearing or 1 
calendar day prior to an expedited hearing. We are proposing to add 
``written testimony'' to recognize that CMS, the IRE, or the Part D 
plan sponsor or a contractor may submit written testimony as a 
participant, in addition to providing oral testimony at a hearing. We 
are proposing to require that position papers and written testimony be 
submitted within 14 calendar days for a standard appeal or 1 calendar 
day for an expedited appeal after receipt of the ALJ's or attorney 
adjudicator's decision on a request to participate if no hearing has 
been scheduled to help ensure the position paper and/or written 
testimony are available when determinations are made to schedule a 
hearing or issue a decision based on the record in accordance with 
Sec.  405.1038. We also are proposing to require that if a hearing is 
scheduled, position papers and written testimony be submitted no later 
than 5 calendar days prior to a non-expedited hearing or 1 calendar day 
prior to an expedited hearing (unless the ALJ grants additional time) 
to help ensure the ALJ and the enrollee have an opportunity to review 
the materials prior to the hearing. Similar to proposed Sec.  
405.1010(c)(3)(iii), we also are proposing at Sec.  423.2010(d)(3)(ii) 
that a copy of the position paper or written testimony must be sent to 
the enrollee, and at Sec.  423.2010(d)(iii) that a position paper or 
written testimony would not be considered in deciding an appeal if CMS, 
the IRE, and/or the Part D plan sponsor fails to send a copy of the 
position paper or written testimony to the enrollee or fails to submit 
the position paper or written testimony within the established time 
frames. This would help ensure CMS, IRE, or Part D plan sponsor 
position papers and written testimony are submitted timely and shared 
with the enrollee.
    Currently, there are no provisions in Sec.  423.2010 to address the 
possibility of CMS, the IRE, and/or the Part D plan sponsor making an 
invalid request to participate. We are proposing to revise Sec.  
423.2010(e) to add new provisions to establish criteria for when a 
request to participate may be deemed invalid and provide standards for 
notifying the entity and the enrollee when a request to participate is 
deemed invalid. Proposed Sec.  423.2010(e)(1) would provide that an ALJ 
or attorney adjudicator may determine a request to participate is 
invalid if the request to participate was not timely filed or the 
request to participate was not sent to the enrollee. This would help 
ensure that CMS, the IRE, and/or the Part D plan sponsor make timely 
requests to participate and inform the enrollee of requests. To provide 
notice to the entity and the enrollee that a request to participate was 
deemed invalid, proposed Sec.  423.2010(e)(2) would require a written 
notice of an invalid request be sent to the entity that made the 
request and the enrollee. If no hearing is scheduled for the appeal or 
the request was made after the hearing occurred, proposed Sec.  
423.2010(e)(2)(i) would provide that the notice of an invalid request 
be sent no later than the date the decision, dismissal, or remand order 
is mailed. If a non-expedited hearing is scheduled for the appeal, 
proposed Sec.  423.2010(e)(2)(ii) would provide that written notice of 
an invalid request is sent prior to the hearing, and that if the notice 
would be sent fewer than 5 calendar days before the hearing, oral 
notice must be provided to the entity, and the written notice must be 
sent as soon as possible after the oral notice is provided. If an 
expedited hearing is scheduled for the appeal, proposed Sec.  
423.2010(e)(2)(iii) would provide that oral notice of an invalid 
request must be provided to the entity, and the written notice must be 
sent as soon as possible after the oral notice is provided. We are 
proposing to require the oral notice for expedited hearings because the 
very short time frames involved in expedited hearing proceedings often 
do not allow for delivery of a written notice and the oral notice will 
help ensure the entity is made aware of the invalid request prior to 
the hearing.
    We are inviting public comments on these proposals. If you choose 
to comment on the proposals in this section, please include the caption 
``Section 423.2010: When CMS, the IRE, or Part D plan sponsors may 
participate in the proceedings on a request for an ALJ hearing'' at the 
beginning of your comment.
iii. Section 405.1012: When CMS or Its Contractors May Be a Party to a 
Hearing
    Current Sec.  405.1012(a) states that CMS and/or its contractors 
may be a party to an ALJ hearing unless the request for hearing is 
filed by an unrepresented beneficiary. Current Sec.  405.1012(b) states 
that CMS and/or the contractor(s) advises the ALJ, appellant, and all 
other parties identified in the notice of hearing that it intends to 
participate as a party no later than 10 calendar days after receiving 
the notice of hearing. Current Sec.  405.1012(c) states that, when CMS 
or its contractors participate in a

[[Page 43815]]

hearing as a party, it may file position papers, provide testimony to 
clarify factual or policy issues, call witnesses or cross-examine the 
witnesses of other parties. CMS or its contractor(s) will submit any 
position papers within the time frame specified by the ALJ. CMS or its 
contractor(s), when acting as parties, may also submit additional 
evidence to the ALJ within the time frame designated by the ALJ. 
Finally, current Sec.  405.1012(d) states that the ALJ may not require 
CMS or a contractor to enter a case as a party or draw any adverse 
inferences if CMS or a contractor decides not to enter as a party. As 
stated previously, we are proposing significant changes to Sec.  
405.1012.
    Current Sec.  405.1012 does not limit the number entities that may 
elect to be a party to the hearing. This has resulted in hearings for 
some appeals being difficult to schedule and taking longer to conduct 
due to multiple elections. To address these issues, we are proposing at 
Sec.  405.1012(a)(1), except as provided in proposed paragraph (d) 
discussed below, to only allow either CMS or one of its contractors to 
elect to be a party to the hearing (unless the request for hearing is 
filed by an unrepresented beneficiary, which precludes CMS and its 
contractors from electing to be a party to the hearing). Current Sec.  
405.1012(b) states that CMS or a contractor advises the ALJ, appellant, 
and all other parties identified in the notice of hearing that it 
intends to participate as a party no later than 10 calendar days after 
receiving the notice of hearing. We are proposing at Sec.  405.1012(a) 
to incorporate and revise a portion of current Sec.  405.1012(b), to 
require that an election to be a party must be filed no later than 10 
calendar days after the QIC receives the notice of hearing, because 
notices of hearing are sent to the QIC in accordance with Sec.  
405.1020(c) (the remaining portion of current Sec.  405.1012(b) is 
incorporated with revisions into proposed Sec.  405.1012(b), as 
discussed below).
    Current Sec.  405.1012 does not have a provision similar to current 
Sec.  405.1010(a), which states that an ALJ may request that CMS and/or 
one or more of its contractors participate in the proceedings, but 
current Sec.  405.1012(d) does provide that the ALJ may not require CMS 
or a contractor to enter a case as a party or draw any adverse 
inference if CMS or a contractor decided not to enter as a party. In 
practice, ALJs do at times request that CMS or a contractor elect to be 
a party to the hearing, in conjunction with a request for participation 
under current Sec.  405.1010(a). To align the provisions and reflect 
ALJ practices, we are proposing at Sec.  405.1012(a)(2) to state that 
an ALJ may request but not require CMS and/or one or more of its 
contractors to be a party to the hearing. We also are proposing in 
Sec.  405.1012(a)(2) to incorporate current Sec.  405.1012(d) to 
provide that that an ALJ cannot draw any adverse inferences if CMS or a 
contractor decides not to enter as a party.
    We are proposing at Sec.  405.1012(b) to address how CMS or a 
contractor elects to be a party to the hearing. We are proposing to 
follow the same process in current Sec.  405.1012(b) so that under 
proposed Sec.  405.1012(b), CMS or the contractor would be required to 
send written notice of its intent to be a party to the hearing to the 
ALJ and the parties identified in the notice of hearing, which includes 
the appellant.
    We are proposing to set forth the roles and responsibilities of CMS 
or a contractor as a party in Sec.  405.1012(c). Proposed Sec.  
405.1012(c)(1) would incorporate current Sec.  405.1012(c) with some 
changes in wording, both of which provide that as a party to the 
hearing, CMS or a contractor may file position papers, submit evidence, 
provide testimony to clarify factual or policy issues, call witnesses, 
or cross-examine the witnesses of other parties. We are proposing in 
Sec.  405.1012(c)(2) to include written testimony, such as an affidavit 
or deposition, in the provision; establish deadlines for submission of 
position papers, written testimony, and evidence; and require that 
copies of position papers, written testimony, and evidence be sent to 
the parties that were sent a copy of the notice of hearing. 
Specifically, we are proposing in Sec.  405.1012(c)(2)(i) and 
(c)(2)(ii) that any position papers, written testimony, and evidence 
must be submitted no later than 5 calendar days prior to the hearing, 
unless the ALJ grants additional time to submit the materials, and 
copies must be sent to the parties who were sent a copy of the notice 
of hearing. We are proposing to add ``written testimony'' to recognize 
that CMS or a contractor may submit written testimony, in addition to 
providing oral testimony at a hearing. We also are proposing to require 
that position papers, written testimony, and/or evidence be submitted 
no later than 5 calendar days prior to the hearing (unless the ALJ 
grants additional time), and that copies be submitted to the parties 
sent notice of the hearing, to help ensure the ALJ and the parties have 
an opportunity to review the materials prior to the hearing. Current 
Sec.  405.1012 does not address the consequence of failure to submit a 
position paper or evidence in accordance with the section. We are 
proposing in Sec.  405.1012(c)(2)(iii) that a position paper, written 
testimony, and/or evidence would not be considered in deciding an 
appeal if CMS or a contractor fails to send a copy of its position 
paper, written testimony, and/or evidence to the parties or fails to 
submit the position paper, written testimony, and/or evidence within 
the established time frames. This would help ensure CMS or contractor 
position papers and evidence are submitted timely and shared with the 
parties.
    As discussed above, current Sec.  405.1012 does not limit the 
number entities (that is, CMS and its contractors) that may elect to be 
a party to the hearing and, as also discussed above, we are proposing 
to revise Sec.  405.1010 and 405.1012 to limit the number of entities 
that participate in a hearing unless an ALJ determines that an entity's 
participation is necessary for a full examination of the matters at 
issue. We are proposing to revise Sec.  405.1012(d)(1) to provide that 
if CMS and one or more contractors, or multiple contractors file 
elections to be a party to a hearing, the first entity to file its 
election after the notice of hearing is issued is made a party to the 
hearing and the other entities are made participants in the proceedings 
under Sec.  405.1010, subject to Sec.  405.1010(d)(1) and (3) (and as 
such may file position papers and provide written testimony to clarify 
factual or policy issues in the case, but may not participate in the 
oral hearing unless the ALJ grants leave to the entity to participate 
in the oral hearing in accordance with Sec.  405.1010(d)(3)). Similar 
to proposed Sec.  405.1010(d)(3), we are also proposing in Sec.  
405.1012(d)(2) that, notwithstanding the limitation in proposed Sec.  
405.1012(d)(1), an ALJ may grant leave for additional entities to be 
parties to the hearing if the ALJ determines that an entity's 
participation as a party is necessary for full examination of the 
matters at issue.
    We believe allowing the first entity to file an election after a 
notice of hearing is issued to be a party to the hearing is 
administratively efficient and provides an objective way to determine 
which entity is made a party based on the competing elections, while 
providing an opportunity to participate in the appeal by filing a 
position paper and/or written testimony under Sec.  405.1010 for those 
that file later in time, or to be made a participant or party to the 
hearing by the ALJ under the ALJ's discretionary authority under 
proposed Sec. Sec.  405.1010(d)(3) and 405.1012(d)(2). We considered an 
alternate proposal of the first entity that had elected

[[Page 43816]]

participant status under Sec.  405.1010, if any, being given priority 
for being made a party to the hearing, but believe that would result in 
other entities making a party election being uncertain whether they 
will be made a party to the hearing until as few as 5 days prior to the 
hearing (assuming the notice of hearing is sent 20 days prior to the 
scheduled hearing, as required by Sec.  405.1022(a), the QIC receives 
the notice of hearing 5 days later, and the entity or entities 
responding to the notice of hearing can make their election as late as 
10 calendar days after the QIC's receipt of the notice, leaving only 5 
days prior to the hearing). We also considered a process by which the 
ALJ would assess which entity making a party election would be most 
helpful to the ALJ at the hearing, or in the alternative, permitting 
all entities that filed a party election to be made a party to the 
hearing unless the ALJ determined an entity is not necessary for the 
hearing, but both of these approaches would add administrative burden 
to the ALJ and could result in CMS, contractors and parties being 
uncertain of which entities will be parties to the hearing until 
shortly before the hearing. We welcome comments on the alternatives 
considered above.
    Finally, we are proposing to add new Sec.  405.1012(e) to address 
the possibility of CMS or a contractor making an invalid election. 
Proposed Sec.  405.1012(e)(1) would provide that an ALJ or attorney 
adjudicator may determine an election is invalid if the request for 
hearing was filed by an unrepresented beneficiary, the election was not 
timely, the election was not sent to the correct parties, or CMS or a 
contractor had already filed an election to be a party to the hearing 
and the ALJ did not determine that the entity's participation as a 
party is necessary for a full examination of the matters at issue. This 
would help ensure that CMS and its contractors make timely elections 
and inform parties of elections, and also provide a mechanism to 
address an election when the request for hearing was filed by an 
unrepresented beneficiary or when another entity has already filed an 
election to be a party to the hearing. To provide notice to the entity 
and the parties that an election was deemed invalid, proposed Sec.  
405.1012(e)(2) would require a written notice of an invalid election be 
sent to the entity that made the election and the parties who were sent 
the notice of hearing. If the election was submitted after the hearing 
occurred, proposed Sec.  405.1012(e)(2)(i) would provide that the 
notice of an invalid election be sent no later than the date the 
decision, dismissal, or remand notice is mailed. If the election was 
submitted before the hearing occurs, proposed Sec.  405.1012(e)(2)(ii) 
would provide that the written notice of invalid election is sent prior 
to the hearing, and that if the notice would be sent fewer than 5 
calendar days before the hearing is scheduled to occur, oral notice 
would be provided to the entity that submitted the election, and the 
written notice to the entity and the parties who were sent the notice 
of hearing would be sent as soon as possible after the oral notice is 
provided.
    We are inviting public comments on these proposals. If you choose 
to comment on the proposals in this section, please include the caption 
``Section 405.1012: When CMS or its contractors may be a party to a 
hearing'' at the beginning of your comment.
g. Request for an ALJ Hearing or Review of a QIC or IRE Dismissal 
(Sec. Sec.  405.1014, 423.1972 and 423.2014)
    Current Sec. Sec.  405.1014 and 423.2014 explain the requirements 
for requesting an ALJ hearing, including what must be contained in the 
request, when and where to file the request, the extension of time to 
request a hearing, and in Sec.  405.1014 to whom a copy of the request 
for hearing must be sent. We are proposing to restructure the sections, 
clarify and provide additional instructions, and address other matters 
that have caused confusion for parties and adjudicators.
i. Requirements for a Request for Hearing or Review of a QIC or IRE 
Dismissal
    We are proposing to revise the title and provisions of Sec. Sec.  
405.1014 and 423.2014 to more clearly cover a request for a review of a 
QIC or IRE dismissal. While the current requirements for requesting an 
ALJ hearing are generally used for requesting a review of a QIC or IRE 
dismissal in form HHS-725, we believe that explicitly extending 
Sec. Sec.  405.1014 and 423.2014 to cover requests for these types of 
review would provide clarity to parties and adjudicators on the 
requirements for requesting a review of a QIC or IRE dismissal. As 
such, we are proposing in the title to Sec.  405.1014 and in subsection 
(a)(1) (current subsection (a)) to add ``or a review of a QIC 
dismissal'' after ``ALJ hearing,'' and in subsection (c) (current 
subsection (b)) to delete ``after a QIC reconsideration'' and add ``or 
request for review of a QIC dismissal'' after ``an ALJ hearing.'' 
Similarly, we are proposing in the title to Sec.  423.2014 and in 
subsection (a)(1) (current subsection (a)) to add ``or a review of an 
IRE dismissal'' after ``ALJ hearing,'' and in subsection (d) (current 
subsection (c)) to add ``or request for review of an IRE dismissal'' 
after ``IRE reconsideration.''
    We are proposing in Sec.  405.1014(a)(1)(i) through (a)(1)(vi) to 
incorporate current Sec.  405.1014(a)(1) through (a)(6) with revisions. 
In addition to the current requirements in subsection (a)(1), we are 
proposing in Sec.  405.1014(a)(1)(i) to require the beneficiary's 
telephone number if the beneficiary is the filing party and is not 
represented. This would help ensure that OMHA is able to make timely 
contact with the beneficiary to clarify his or her filing, or other 
matters related to the adjudication of his or her appeal, including 
scheduling the hearing. We are proposing in Sec.  405.1014(a)(1)(ii) to 
require the appellant's telephone number, along with the appellant's 
name and address as currently required in subsection (a)(2), when the 
appellant is not the beneficiary, and in Sec.  405.1014(a)(1)(iii) to 
require a representative's telephone number, along with the 
representative's name and address which is currently included in 
subsection (a)(3), if a representative is involved. Like the 
beneficiary telephone number requirement, these requirements would help 
ensure that OMHA is able to make timely contact with a non-beneficiary 
appellant and any representative involved in the appeal to clarify the 
filing or other matters related to the adjudication of the appeal, 
including scheduling the hearing. Current subsection (a)(4) states that 
the request must include the document control number assigned to the 
appeal by the QIC, if any. We are proposing in Sec.  405.1014(a)(1)(iv) 
to require the Medicare appeal number or document control number, if 
any, assigned to the QIC reconsideration or dismissal notice being 
appealed, to reduce confusion for appellants. We are proposing in Sec.  
405.1014(a)(1)(v) to add language to the current language in subsection 
(a)(5), so that instead of requiring the ``dates of service,'' we would 
require the ``dates of service for the claims being appealed, if 
applicable,'' because an appellant may appeal some but not all of the 
partially favorable or unfavorable claims in a QIC reconsideration and 
a small number of appeals do not involve a date of service (for 
example, entitlement appeals). We are proposing to incorporate the same 
language in current subsection (a)(6) into proposed subsection 
(a)(1)(vi).
    We are proposing to add a new requirement to the content of the 
request in Sec.  405.1014(a)(1)(vii) by

[[Page 43817]]

requiring a statement of whether the filing party is aware that it or 
the claim is the subject of an investigation or proceeding by the OIG 
or other law enforcement agencies. This information is necessary to 
assist OMHA staff in checking whether the provider or supplier was 
excluded from the program on the date of service at issue prior to 
scheduling a hearing or issuing a decision, as well as for the ALJ to 
determine whether to request the participation of CMS or any program 
integrity contractors that may have been involved in reviewing the 
claims below. However, we note that the information is only required if 
the filing party is aware of an investigation and proceeding, and the 
information would not be the basis for a credibility determination on 
evidence or testimony, as an investigation or allegations prior to 
findings of wrongdoing by a court of competent jurisdiction are not an 
appropriate foundation for credibility determinations in the context of 
part 405, subpart I administrative appeals.
    As discussed in Section III.A.3.d above, we are proposing changes 
to the methodology for calculating the amount in controversy required 
for an ALJ hearing to better align the amount in controversy with the 
actual amount in dispute. We are also proposing new Sec.  
405.1014(a)(1)(viii) to require that providers, suppliers, Medicaid 
State agencies, applicable plans, and beneficiaries represented by a 
provider, supplier, or Medicaid State agency include in their request 
for hearing the amount in controversy applicable to the disputed claim, 
as specified in Sec.  405.1006(d), unless the matter involves a 
provider or supplier termination of Medicare-covered items or services 
that is disputed by a beneficiary, and the beneficiary did not elect to 
continue receiving the items or services. As we discussed in section 
III.A.3.d., in instances where the Medicare allowable amount would 
serve as the basis for the amount in controversy (which we believe 
would be the majority of Part B appeals), we believe providers, 
suppliers, and Medicaid State agencies would be able to utilize 
existing CMS tools and resources to determine the allowable amount used 
as the basis for the amount in controversy under proposed Sec.  
405.1006(d)(2)(i)(A) and arrive at the amount in controversy after 
deducting any Medicare payments that have already been made or awarded 
and any deductible and/or coinsurance that may be collected for the 
items and services in the disputed claim. In addition, we believe that 
providers, suppliers, applicable plans, and Medicaid State agencies 
also would have access to the billing, payment and other necessary 
information to calculate the amount in controversy under other 
provisions of Sec.  405.1006(d). For scenarios where the basis for the 
amount in controversy would be calculated in accordance with proposed 
Sec.  405.1006(d)(2)(i)(B), (ii), (iii), or where the amount in 
controversy would be calculated in accordance with Sec.  
405.1006(d)(3), (5), (6), or (7), we discuss in section III.A.3.d above 
how appellants would determine the amount in controversy in order to 
include it on their request for hearing. However, because we believe 
there may be instances where a beneficiary who is not represented by a 
provider, supplier, or Medicaid State agency may not have the 
information necessary to determine the amount in controversy under 
Sec.  405.1006(d) (as discussed above), we are not proposing to require 
beneficiaries who are not represented by a provider, supplier, or 
Medicaid State agency to include the amount in controversy in their 
requests for hearing. Furthermore, as noted above, we are not proposing 
that any appellant include the amount in controversy on requests for 
hearing where the amount in controversy would be calculated in 
accordance with Sec.  405.1006(d)(4) (for a provider or supplier 
termination of Medicare-covered items or services that is disputed by a 
beneficiary, and the beneficiary did not elect to continue receiving 
the items or services). We expect that, in this situation, a 
beneficiary could easily determine whether the minimum amount in 
controversy required for an ALJ hearing would be met through a 
conversation with the provider or supplier, or from the statement we 
are proposing the QIC include in its notice of reconsideration as 
discussed in section III.A.3.d above. However, we believe the exact 
amount in controversy could be difficult to determine because it may 
depend on unknown factors, such as the length of continued services 
that may be required, and so we are not requiring appellants to include 
this amount in the request for hearing.
    Lastly, current Sec.  405.1014(a)(7), which requires a statement of 
any additional evidence to be submitted and the date it will be 
submitted, would be separately designated in its entirety as proposed 
Sec.  405.1014(a)(2) because the information in proposed Sec.  
405.1014(a)(1) must be present for a request for hearing to be 
processed and therefore would make the request subject to dismissal if 
the information is not provided, as discussed below. In contrast, the 
information in proposed Sec.  405.1014(a)(2) is only necessary if 
evidence would be submitted and would not make the request subject to 
dismissal if not present in the request.
    Similar to proposed Sec.  405.1014(a), we are proposing at Sec.  
423.2014(a)(1)(i) through (a)(1)(vi) to incorporate current Sec.  
423.2014(a)(1) through (a)(6) with revisions. Current subsection (a)(3) 
states that the request must include the appeals case number assigned 
to the appeal by the IRE, if any. We are proposing in Sec.  
405.1014(a)(1)(iii) to revise the requirement to state that the request 
must include the Medicare appeal number, if any, assigned to the IRE 
reconsideration or dismissal being appealed, to reflect the terminology 
used by the IRE and thereby reduce confusion for enrollees. Current 
subsection (a)(6) states that the request must include the reasons the 
enrollee disagrees with the IRE's reconsideration. We are proposing to 
insert ``or dismissal'' after ``reconsideration'' to again reflect the 
terminology used by the IRE and thereby reduce confusion for enrollees. 
For the same reasons as we proposed for Sec.  405.1014(a)(1)(vii), we 
are proposing at Sec.  423.2014(a)(1)(vii) to require a statement of 
whether the enrollee is aware that he or she, or the prescription for 
the drug being appealed, is the subject of an investigation or 
proceeding by the OIG or other law enforcement agencies. In addition, 
we are proposing at Sec.  423.2014(a)(2) to incorporate the current 
Sec.  423.2014(a)(7) requirement to include a statement of any 
additional evidence to be submitted and the date it will be submitted, 
and at Sec.  423.2014(a)(3) to incorporate the current Sec.  
423.2014(a)(8) requirement to include a statement that the enrollee is 
requesting an expedited hearing, if applicable.
    We are inviting public comments on these proposals. If you choose 
to comment on the proposals in this section, please include the caption 
``Requirements for a request for hearing or review of a QIC or IRE 
dismissal'' at the beginning of your comment.
ii. Requests for Hearing Involving Statistical Sampling and 
Extrapolations
    We are proposing to add new Sec.  405.1014(a)(3) to address appeals 
in which an appellant raises issues regarding a statistical sampling 
methodology and/or an extrapolation that was used in making an 
overpayment determination. OMHA has encountered significant issues when 
an appellant challenges aspects of a statistical sampling methodology 
and/or the results of extrapolations in separate

[[Page 43818]]

appeals for each sampled claim involved in the statistical sampling 
and/or extrapolation. Appeals often need to be reassigned to avoid 
multiple adjudicators addressing the challenges to the statistical 
sampling methodology and/or extrapolation, and any applicable 
adjudication time frames attach to the individual appeals. Under 
proposed Sec.  405.1014(a)(3), if an appellant is challenging the 
statistical sampling methodology and/or extrapolation, the appellant's 
request for hearing must include the information in proposed Sec.  
405.1014(a)(1) and (a)(2) for each sample claim that the appellant 
wishes to appeal, be filed within 60 calendar days of the date that the 
party received the last reconsideration for the sample claims (if they 
were not all addressed in a single reconsideration), and assert the 
reasons the appellant disagrees with the statistical sampling 
methodology and/or extrapolation in the request for hearing. We believe 
it would be appropriate in this situation to allow the appellant's 
request for hearing to be filed within 60 calendar days of the date 
that the party received the last reconsideration for the sample claims 
(if they were not all addressed in a single reconsideration), because 
if the appellant also wishes to challenge the statistical sampling 
methodology and/or extrapolation, the appellant would wait to file a 
request for hearing until all of the QIC reconsiderations for the 
sample units are received, which could be more than 60 calendar days 
after the first received QIC reconsideration of one of the sample 
claims. We also state that the 60 calendar day period in proposed Sec.  
405.1014(a)(3)(ii) would begin on the date the party receives the last 
reconsideration of a sample claim, regardless of the outcome of the 
claim in the reconsideration or whether the sample claim is appealed in 
the request for hearing. We believe proposed Sec.  405.1014(a)(3) would 
balance the party's rights to request a hearing on individual claims 
when only the sample claims are appealed, with the needs to 
holistically address issues related to statistical sampling 
methodologies and extrapolations when those determinations are also 
challenged. We are not proposing any corresponding changes to Sec.  
423.2014 because sampling and extrapolation are not currently used in 
Part D appeals.
    We are inviting public comments on these proposals. If you choose 
to comment on the proposals in this section, please include the caption 
``Requests for hearing involving statistical sampling and 
extrapolations'' at the beginning of your comment.
iii. Opportunity To Cure Defective Filings
    There has been considerable confusion on the implications of not 
providing the information required by current Sec.  405.1014(a) in 
order to perfect a request for hearing, and significant time and 
resources have been spent on this procedural matter by parties, OMHA, 
and the Council. To provide clearer standards and reduce confusion, we 
are proposing in Sec.  405.1014(b)(1) that a request for hearing or 
request for a review of a QIC dismissal must contain the information 
specified in proposed Sec.  405.1014(a)(1) to the extent the 
information is applicable, to be complete, and Sec.  405.1014(b)(1) 
would provide that any applicable adjudication time frame does not 
begin until the request is complete because the information is 
necessary to the adjudication of the appeal. We are proposing in Sec.  
405.1014(b)(1) to also provide an appellant with an opportunity to 
complete the request if the request is not complete. However, if the 
appellant fails to provide the information necessary to complete the 
request in the time frame provided, the request would not be complete 
and would be dismissed in accordance with proposed Sec.  405.1052(a)(7) 
or (b)(4). We are also proposing at Sec.  405.1014(b)(2) to allow for 
consideration of supporting materials submitted with a request when 
determining whether the request is complete, provided the necessary 
information is clearly identifiable in the materials, to provide that 
an appellant's request and supporting materials is considered in its 
totality. For example, if an appellant were to submit a request for 
hearing and included a copy of the QIC reconsideration, the Medicare 
appeal number on the QIC reconsideration would generally satisfy the 
subsection (a)(1)(iv) requirement because it clearly provides the 
information. However, if there are multiple claims in the QIC 
reconsideration, the same document possibly would not satisfy 
subsection (a)(1)(v) because the appellant is not required to appeal 
all partially favorable or unfavorable claims, and subsection (a)(1)(v) 
requires the appellant to indicate the dates of service for the claims 
that are being appealed. Similarly, including medical records only for 
the dates of service that the appellant wishes to appeal would 
generally not satisfy subsection (a)(1)(v) because it would be unclear 
whether the appellant intended to limit the appeal to only those dates 
of service for which medical records were included, or those were the 
only dates of service for which the appellant had medical records. We 
are proposing that the provisions of proposed Sec.  405.1014(b) be 
adopted in proposed Sec.  423.2014(c) for requesting an ALJ hearing or 
a review of an IRE dismissal in Part D appeals.
    We are inviting public comments on these proposals. If you choose 
to comment on the proposals in this section, please include the caption 
``Opportunity to cure defective filings'' at the beginning of your 
comment.
iv. Where and When To File a Request for Hearing or Review of a QIC or 
IRE Dismissal
    We are proposing to incorporate portions of current Sec.  
405.1014(b) in proposed Sec.  405.1014(c) and portions of current Sec.  
423.2014(c) in proposed Sec.  423.2014(d) to address when and where to 
file a request for hearing or review. We are proposing in Sec. Sec.  
405.1014(c) introductory language and (c)(1), and 423.2014(d) 
introductory language and (d)(1), to incorporate a request for a review 
of a QIC dismissal and a request for a review of an IRE dismissal, 
respectively, and provide that the current 60 calendar day period to 
file a request for hearing after a party receives a QIC or an IRE 
reconsideration also applies after a party receives a QIC or IRE 
dismissal, which is the time frame stated in Sec. Sec.  405.1004 and 
423.2004 to request a review of a QIC or IRE dismissal, respectively. 
We also are proposing in Sec.  405.1014(c)(1) to add an exception for 
requests filed in accordance with proposed Sec.  405.1014(a)(3)(ii), 
because as discussed above, we are proposing to require that requests 
for hearing on sample claims that are part of a statistical sample and/
or extrapolation that the appellant also wishes to challenge would be 
filed together, which may be more than 60 calendar days after the 
appellant receives the first QIC reconsideration of one of the sample 
claims. In addition, we are proposing to revise the statement that a 
request must be ``submitted'' in current Sec.  423.2014(c)(1), with a 
request must be ``filed'' in Sec.  423.2014(d)(1), for consistency with 
Sec.  405.1014 and Sec.  422.602, both of which use the term ``filed.'' 
We are also proposing in Sec. Sec.  405.1014(c)(2) and 423.2014(d)(2) 
to replace references to sending requests to the ``entity'' specified 
in the QIC's or IRE's reconsideration in current Sec. Sec.  
405.1014(b)(2) and 423.2014(c)(2), with sending requests to the 
``office'' specified in the QIC's or IRE's reconsideration or 
dismissal, respectively, so they are properly routed. As discussed in 
III.A.3.b. and III.A.3.c, above, regarding proposed

[[Page 43819]]

Sec. Sec.  405.1002 and 405.1004, and 423.2002 and 423.2004, replacing 
``entity'' with ``office'' in Sec. Sec.  405.1014, 423.1972, and 
423.2014 would help ensure appellants are aware that a request for 
hearing or request for a review of a QIC or IRE dismissal must be filed 
with the office indicated in the QIC's or IRE's reconsideration or 
dismissal and avoid delays. However, we again note that for the few 
requests for hearing that are misrouted by a party, a notice would be 
sent to the appellant when the request for hearing is received in the 
correct office and the date the timely request was received by the 
incorrect office would be used to determine the timeliness of the 
request, in accordance with proposed Sec. Sec.  405.1014(c)(2) and 
423.2014(d)(2)(i), which would incorporate the misrouted request 
provisions from current Sec. Sec.  405.1014(b)(2) and 
423.2014(c)(2)(i). We are also proposing in Sec. Sec.  405.1014(c)(2) 
and 423.2014(d)(2)(i) that the adjudication time frame is only affected 
if there is an applicable adjudication time frame for the appeal.
    Current Sec.  423.1972(b) states that an enrollee must file a 
request for a hearing within 60 calendar days of the date of the notice 
of the IRE reconsideration determination. This requirement differs from 
Sec.  423.2002(a)(1), which states that a request for hearing must be 
filed within 60 calendar days after receipt of the IRE's 
reconsideration (this is also the standard for filing Part A and Part B 
requests for hearing after receipt of QIC reconsiderations, at Sec.  
405.1002(a)(1). We are proposing to revise Sec.  423.1972(b)(1) to 
state that a request for hearing must be filed within 60 calendar days 
after receipt of the IRE's reconsideration. We also are proposing to 
add new Sec.  423.1972(b)(2), to incorporate current Sec.  423.2002(d), 
which provides the date of receipt of the reconsideration is presumed 
to be 5 calendar days after the date of the written reconsideration 
unless there is evidence to the contrary (this is also a presumption 
for receipt of QIC reconsiderations in Part A and Part B appeals, at 
Sec.  405.1002). These changes would align proposed Sec.  423.1972(b) 
with current Sec.  423.2002, and remove potential enrollee confusion on 
when a request for an ALJ hearing must be filed.
    We are inviting public comments on these proposals. If you choose 
to comment on the proposals in this section, please include the caption 
``Where and when to file a request for hearing or review of a QIC or 
IRE dismissal'' at the beginning of your comment.
v. Sending Copies of a Request for Hearing and Other Evidence to Other 
Parties to the Appeal
    We are proposing to incorporate the portion of current Sec.  
405.1014(b)(2) that states that the appellant must also send a copy of 
the request for hearing to the other parties and failure to do so will 
toll the ALJ's 90 calendar day adjudication deadline until all parties 
to the QIC reconsideration receive notice of the requested ALJ hearing 
in proposed Sec.  405.1014(d) with changes discussed below. Current 
Sec.  405.1014(b)(2) has been another source of considerable confusion, 
and significant time and resources have been spent on this procedural 
matter by parties, OMHA, and the Council. Current Sec.  405.1014(b)(2) 
requires an appellant to send a copy of the request for hearing to the 
other parties. Other parties consist of all of the parties specified in 
Sec.  405.906(b) as parties to the reconsideration, including 
beneficiaries in overpayment cases that involve multiple beneficiaries 
who have no liability, in which case the QIC may elect to only send a 
notice of reconsideration to the appellant, in accordance with Sec.  
405.976(a)(2). We are proposing in Sec.  405.1014(d)(1) to amend the 
current copy requirement by only requiring an appellant to send a copy 
of a request for an ALJ hearing or review of a QIC dismissal to the 
other parties who were sent a copy of the QIC's reconsideration or 
dismissal. This change would make the standard consistent with requests 
for Council review, a copy of which must be sent by the appellant to 
the other parties who received a copy of an ALJ's decision or 
dismissal, in accordance with current Sec.  405.1106(a). This change 
would also extend the requirement to requests for review of a QIC 
dismissal to provide the other parties who received notice of the QIC's 
dismissal action with notice of the appellant's appeal of that action.
    We are also proposing in Sec.  405.1014(d)(1) to address whether 
copies of materials that an appellant submits with a request for 
hearing or request for review of a QIC dismissal must be sent to other 
parties. Currently some ALJs consider the materials to be part of the 
request and require an appellant to send copies of all materials 
submitted with a request, while other ALJs do not consider the 
materials to be part of the request. We are proposing in Sec.  
405.1014(d)(1) that if additional materials submitted with a request 
are necessary to provide the information required for a complete 
request in accordance with proposed Sec.  405.1014(b), copies of the 
materials must be sent to the parties as well (subject to authorities 
that apply to disclosing the personal information of other parties). If 
additional evidence is submitted with the request for hearing, the 
appellant may send a copy of the evidence or briefly describe the 
evidence pertinent to the party and offer to provide copies of the 
evidence to the party at the party's request (subject to authorities 
that apply to disclosing the evidence). For example, if a complete 
request includes a position paper or brief that explains the reasons 
the appellant disagrees with the QIC's reconsideration, in accordance 
with proposed Sec.  405.1014(a)(1)(v), a copy of the position paper or 
brief would be sent to the other parties, subject to any authorities 
that apply to disclosing the personal information of other parties. 
However, additional evidence such as medical records, is generally not 
required for a complete request, and therefore copies would not have to 
be sent, but could instead be summarized and provided to the other 
parties at their request, again subject to any authorities that apply 
to disclosing the personal information of other parties. This approach 
would balance the objectives of ensuring that parties to a claim and an 
appeal of that claim remain informed of the proceedings that are 
occurring on the claim, with the burdens on appellants to keep their 
co-parties so informed. We also note that in sending a copy of the 
request for hearing and associated materials, appellants are free to 
include cover letters to explain the request, but we note that such 
letters on their own do not satisfy the copy requirement in its current 
or proposed form. No corresponding changes are proposed in Sec.  
423.2014 because the enrollee is the only party to the appeal.
    Current Sec.  405.1014 does not contain standards for what 
constitutes evidence that a copy of the request for hearing or review, 
or copy of the evidence or a summary thereof, was sent to the other 
parties, which has led to confusion and inconsistent practices. 
Therefore, we are proposing in Sec.  405.1014(d)(2) to address this 
issue by establishing standards that an appellant would follow to 
satisfy the requirement. We are proposing in Sec.  405.1014(d)(2) that 
evidence that a copy of the request for hearing or review, or a copy of 
submitted evidence or a summary thereof, was sent includes: (1) 
Certifications that a copy of the request for hearing or request for 
review of a QIC dismissal is being sent to the other parties on the 
standard form for requesting a hearing or review of a QIC dismissal; 
(2) an indication, such as a copy or ``cc'' line on a request for

[[Page 43820]]

hearing or review, that a copy of the request and any applicable 
attachments or enclosures are being sent to the other parties, 
including the name and address of the recipients; (3) an affidavit or 
certificate of service that identifies the name and address of the 
recipient and what was sent to the recipient; or (4) a mailing or 
shipping receipt that identifies the name and address of the recipient 
and what was sent to the recipient. We believe these options would 
provide an appellant with flexibility to document the copy requirement 
was satisfied and bring consistency to the process.
    Beyond stating that an adjudication time frame is tolled if a party 
does not satisfy the copy requirement, current Sec.  405.1014 does not 
address the consequence of not satisfying the requirement, and 
adjudicators are faced with an appeal being indefinitely tolled because 
an appellant refuses to comply with the requirement. OMHA ALJs have 
addressed this issue by providing appellants with an opportunity to 
send the required copy of the request for hearing, and by informing the 
appellant that if the copy is not sent, its request will be dismissed. 
This allows OMHA ALJs to remove requests that do not satisfy the 
requirement from their active dockets so time and resources can be 
focused on appeals of those who comply with the rules. We are proposing 
in Sec.  405.1014(d)(3) that, if the appellant fails to send a copy of 
the request for hearing or request for review of a QIC dismissal, any 
additional materials, or a copy of the submitted evidence or a summary 
thereof, the appellant would be provided with an opportunity to cure 
the defects by sending the request, materials, and/or evidence or 
summary thereof described in proposed subsection (d)(1). Further, 
proposed Sec.  405.1014(d)(3) would provide that if an adjudication 
time frame applies, it does not begin until evidence that the request, 
materials, and/or evidence or summary thereof were sent is received. We 
are also proposing in Sec.  405.1014(d)(3) that if an appellant does 
not provide evidence within the time frame provided to demonstrate that 
the request, materials, and/or evidence or summary thereof were sent to 
other parties, the appellant's request for hearing or review would be 
dismissed.
    We are inviting public comments on these proposals. If you choose 
to comment on the proposals in this section, please include the caption 
``Sending copies of a request for hearing and other evidence to other 
parties to the appeal'' at the beginning of your comment.
vi. Extending Time To File a Request for Hearing or Review of a QIC or 
IRE Dismissal
    We are proposing that the provisions of current Sec. Sec.  
405.1014(c) and 423.2014(d) for extensions of time to file a request 
for hearing would be incorporated in proposed Sec. Sec.  405.1014(e) 
and 423.2014(e) with changes, and would extend to requests for reviews 
of QIC and IRE dismissals. On occasion, OMHA is asked whether a request 
for an extension should be filed without a request for hearing, for a 
determination on the request for extension before the request for 
hearing is filed. In those instances, we ask the filer to file both the 
request for hearing and request for extension at the same time because 
an independent adjudication of the extension request would be 
inefficient and any adjudication time frame begins on the date that the 
ALJ grants the extension request, in accordance with current Sec. Sec.  
405.1014(c)(4) and 423.2014(d)(4). We are proposing in Sec. Sec.  
405.1014(e)(2) and 423.2014(e)(3) to require a request for an extension 
be filed with the request for hearing or request for review of a QIC or 
IRE dismissal, with the office specified in the notice of 
reconsideration or dismissal. Proposed Sec. Sec.  405.1014(e)(2) and 
423.2014(e)(3) would also align the provision with proposed Sec. Sec.  
405.1014(c) and 423.2014(d) by specifying that a request for an 
extension must be filed with the ``office,'' rather than the 
``entity,'' specified in the notice of reconsideration. We are 
proposing in Sec.  405.1014(e)(3) and 423.2014(e)(4) that an ALJ or 
attorney adjudicator may find good cause to extend the deadline to file 
a request for an ALJ hearing or a request for a review of a QIC or IRE 
dismissal, or there is no good cause for missing the deadline to file a 
request for a review of a QIC or IRE dismissal, but only an ALJ may 
find there is no good cause for missing the deadline to file a request 
for an ALJ hearing. Because only an ALJ may dismiss a request for an 
ALJ hearing for an untimely filing in accordance with proposed 
Sec. Sec.  405.1052 and 423.2052, an attorney adjudicator could not 
make a determination on a request for an extension that would result in 
a dismissal of a request for hearing. We are also proposing to 
incorporate current Sec. Sec.  405.1014(c)(4) and 423.2014(d)(5) into 
proposed Sec. Sec.  405.1014(e)(4) and 423.2014(e)(5), but indicate 
that the adjudication time frame begins on the date the ALJ or attorney 
adjudicator grants the request to extend the filing deadline only if 
there is an applicable adjudication period. Finally, we are proposing 
in Sec. Sec.  405.1014(e)(5) and 423.2014(e)(6) to add a new provision 
to provide finality for the appellant with regard to a determination to 
grant an extension of the filing deadline. We are proposing that if an 
ALJ or attorney adjudicator were to make a determination to grant the 
extension, the determination is not subject to further review. However, 
we are not precluding review of a determination to deny an extension 
because such a denial would result in a dismissal for an untimely 
filing, and the dismissal and determination on the request for an 
extension would be subject to review by the Council.
    We are inviting public comments on these proposals. If you choose 
to comment on the proposals in this section, please include the caption 
``Extending time to file a request for hearing or review of a QIC or 
IRE dismissal'' at the beginning of your comment.
h. Time Frames for Deciding an Appeal of a QIC or IRE Reconsideration 
or an Escalated Request for a QIC Reconsideration, and Request for 
Council Review When an ALJ Does Not Issue a Decision Timely (Sec. Sec.  
405.1016, 405.1104 and 423.2016)
i. Section 405.1016: Time frames for Deciding an Appeal of a QIC or an 
Escalated Request for a QIC Reconsideration
    Current Sec.  405.1016 addresses the adjudication time frames for 
requests for hearing filed after a QIC has issued its reconsideration, 
in accordance with section 1869(d)(1)(A) of the Act, and escalations of 
requests for a QIC reconsideration when the QIC does not issue its 
reconsideration within its adjudication time frame, which is permitted 
by section 1869(c)(3)(C)(ii) of the Act. We are proposing to revise the 
title of Sec.  405.1016 from ``Time frames for deciding an appeal 
before an ALJ'' to ``Time frames for deciding an appeal of a QIC 
reconsideration or escalated request for a QIC reconsideration'' 
because the section specifically applies to appeals of QIC 
reconsiderations and escalated requests for QIC reconsiderations (as 
specified in current and proposed Sec.  405.1016(a) and (c)). This 
revision would also allow for application of this section to requests 
for hearing adjudicated by attorney adjudicators, as proposed in 
Section II.B. above. We also are proposing to replace each instance of 
the term ``the ALJ'' with ``the ALJ or attorney adjudicator'' 
throughout proposed Sec.  405.1016 to assist appellants in 
understanding that an adjudication time frame, and the option to 
escalate, also

[[Page 43821]]

would apply to a request for an ALJ hearing following a QIC 
reconsideration when the request has been assigned to an attorney 
adjudicator, as proposed in section II.B, above. We are not proposing 
to change the reference to ``a request for an ALJ hearing'' because, as 
explained above in section II.B, even if an appellant waives its right 
to hearing, the case would remain subject to a potential oral hearing 
before an ALJ, and we believe the request is therefore properly 
characterized as a request for an ALJ hearing.
    We are proposing to add titles to proposed Sec.  405.1016(a) to 
indicate that this paragraph discusses the adjudication period for 
appeals of QIC reconsiderations, and proposed Sec.  405.1016(c) to 
indicate that this paragraph discusses the adjudication period for 
escalated requests for QIC reconsiderations. In addition, proposed 
Sec.  405.1016(a) and (c) would remove ``must,'' in providing that when 
a request for an ALJ hearing is filed after a QIC has issued a 
reconsideration, an ALJ or attorney adjudicator issues a decision, 
dismissal order, or remand to the QIC, as appropriate, no later than 
the end of the 90 calendar day period beginning on the date the request 
for hearing is received by the office specified in the QIC's notice of 
reconsideration. While the statute envisions that appeals will be 
adjudicated within the statutory time frame, the statute also provides 
for instances in which the adjudication time frame is not met by 
allowing an appellant to escalate his or her appeal to the next level 
of appeal. We believe ``must'' should be reserved for absolute 
requirements, and in the context of adjudication time frames, the 
statute provides the option for an appellant to escalate an appeal if 
the adjudication time frame is not met.
    We are proposing to add a title to proposed Sec.  405.1016(b) to 
indicate that the paragraph discusses when an adjudication period 
begins. Current Sec.  405.1016(b), which explains that the adjudication 
period for an appeal of a QIC reconsideration begins on the date that a 
timely filed request for hearing is received unless otherwise specified 
in the subpart, would be re-designated as proposed Sec.  
405.1016(b)(1). We are proposing in Sec.  405.1016(b)(2) that if the 
Council remands a case and the case was subject to an adjudication time 
frame under paragraph (a) or (c), the remanded appeal would be subject 
to the adjudication time frame of Sec.  405.1016(a) beginning on the 
date that OMHA receives the Council remand. Currently the regulations 
do not address whether an adjudication time frame applies to appeals 
that are remanded from the Council, and whether escalation is an option 
for these appeals. To provide appellants with an adjudication time 
frame for remanded appeals that were subject to an adjudication time 
frame when they were originally appealed to OMHA, proposed Sec.  
405.1016(b)(2) would apply the adjudication time frame under Sec.  
405.1016(a) to a remanded appeal that was subject to an adjudication 
time frame under paragraph (a) or (c). For example, if an ALJ decision 
reviewed by the Council involved a QIC reconsideration and was remanded 
by the Council, a 90 calendar day time frame would apply from the date 
that OMHA received the remand order. If the adjudication time frame is 
not met under proposed Sec.  405.1016(b)(2), the appeal would be 
subject to escalation, in accordance with proposed Sec.  405.1016(e).
    In addition, we are proposing in Sec.  405.1016(a) and (b) to align 
the paragraphs with proposed Sec.  405.1014(c) by specifying that a 
request for hearing is received by the ``office,'' rather than the 
``entity,'' specified in the QIC's notice of reconsideration.
    We are proposing to add a title to proposed Sec.  405.1016(d) to 
indicate that the paragraph discusses waivers and extensions of the 
adjudication period. We are proposing in Sec.  405.1016(d)(1) to 
incorporate the adjudication period waiver provision in current Sec.  
405.1036(d), which states that, at any time during the hearing process, 
the appellant may waive the adjudication deadline specified in Sec.  
405.1016 for issuing a hearing decision, and that the waiver may be for 
a specific period of time agreed upon by the ALJ and the appellant. We 
are proposing to move the provision because we believe it is more 
appropriately addressed in Sec.  405.1016, as it is directly related to 
the adjudication period. Proposed Sec.  405.1016(d) would also revise 
the language in current Sec.  405.1036(d) to reference an attorney 
adjudicator consistent with our proposals in Section II.B. above; to 
reference the ``adjudication'' process rather than the ``hearing 
process'' to account for appeals that may not involve a hearing, to 
consistently reference an adjudication ``period'' for internal 
consistency, and to replace the reference to Sec.  405.1016 with 
internal paragraph references.
    Current Sec.  405.1016 does not address delays that result from 
stays ordered by U.S. Courts. In addition, we have had instances in 
which an appellant requests a stay of action on his or her appeals 
while related matters are addressed by another court or tribunal, or by 
investigators. To address these circumstances, we are proposing in 
Sec.  405.1016(d)(2) that the adjudication periods specified in 
paragraphs (a) and (c) are extended as otherwise specified in this 
subpart, and for the duration of any stay of action on adjudicating the 
claims or matters at issue ordered by a court or tribunal of competent 
jurisdiction, or the duration of any stay of proceedings granted by an 
ALJ or attorney adjudicator on the motion of the appellant, provided no 
other party also filed a request for hearing on the same claim at 
issue.
    We are inviting public comments on these proposals. If you choose 
to comment on the proposals in this section, please include the caption 
``Section 405.1016: Time frames for deciding an appeal of a QIC or an 
escalated request for a QIC reconsideration'' at the beginning of your 
comment.
ii. Incorporation of the Provisions of Section 405.1104 (Request for 
Council Review When an ALJ Does Not Issue a Decision Timely) Into 
Section 405.1016(f)
    Current Sec.  405.1104 addresses how to request escalation from an 
ALJ to the Council, when an ALJ has not issued a decision, dismissal or 
remand on a QIC reconsideration within an applicable adjudication time 
frame, in accordance with section 1869(d)(3)(A) of the Act in paragraph 
(a); the procedures for escalating an appeal in paragraph (b); and the 
status of an appeal for which the adjudication time frame has expired 
but the appellant has not requested escalation in paragraph (c). We are 
proposing to remove and reserve Sec.  405.1104 and incorporate the 
current Sec.  405.1104 providing for escalating a request for an ALJ 
hearing to the Council into proposed Sec.  405.1016(e) and (f) with 
revisions, as its current placement in the Council portion of part 405, 
subpart I has caused confusion. We also are proposing to insert ``or 
attorney adjudicator'' after ``ALJ'' in proposed Sec.  405.1016(e) and 
(f) to assist appellants in understanding that the effect of exceeding 
the adjudication period and the option to escalate would apply to a 
request for an ALJ hearing following a QIC reconsideration when the 
request has been assigned to an attorney adjudicator, as discussed in 
section II.B, above.
    Current Sec.  405.1104(c) is titled ``No escalation'' and states 
that if the ALJ's adjudication period set forth in Sec.  405.1016 
expires, the case remains pending with the ALJ until a decision, 
dismissal order, or remand order is issued or the appellant requests

[[Page 43822]]

escalation to the Council. We are proposing in Sec.  405.1016(e) to 
incorporate current Sec.  405.1104(c) with changes. We are proposing to 
revise the paragraph title for proposed Sec.  405.1016(e) to indicate 
that the paragraph discusses the effect of exceeding the adjudication 
period. Proposed Sec.  405.1016(e) would provide that if an ALJ or an 
attorney adjudicator assigned to a request for hearing (as proposed in 
section II.B above) does not issue a decision, dismissal order, or 
remand to the QIC within an adjudication period specified in the 
section, the party that filed the request for hearing may escalate the 
appeal when the adjudication period expires. However, if the 
adjudication period expires and the party that filed the request for 
hearing does not exercise the option to escalate the appeal, the appeal 
remains pending with OMHA for a decision, dismissal order, or remand. 
We are proposing to indicate that the appeal remains pending with OMHA 
to be inclusive of situations in which the appeal is assigned to an ALJ 
or attorney adjudicator, or not yet assigned.
    Current Sec.  405.1104(a) describes how to request an escalation 
and states that an appellant who files a timely request for hearing 
before an ALJ and whose appeal continues to be pending before the ALJ 
at the end of the applicable ALJ adjudication period may request 
Council review if the appellant files a written request with the ALJ to 
escalate the appeal to the Council after the adjudication period has 
expired, and the ALJ does not issue a decision, dismissal order, or 
remand order within the later of 5 calendar days of receiving the 
request for escalation or 5 calendar days from the end of the 
applicable adjudication period set forth in Sec.  405.1016. We are 
proposing in Sec.  405.1016(f)(1) to remove the requirement to request 
Council review in the course of requesting an escalation and to 
describe when and how to request escalation. Specifically, we are 
proposing to revise the current procedures at Sec.  405.1104(a) and 
(a)(1), to provide that an appellant who files a timely request for a 
hearing with OMHA and whose appeal continues to be pending at the end 
of an applicable adjudication period may exercise the option to 
escalate the appeal to the Council by filing a written request with 
OMHA to escalate the appeal to the Council, which would simplify the 
process for appellants and adjudicators by only requiring appellants to 
file a single request for escalation with OMHA. We are proposing to 
replace the reference to an appeal that ``continues to be pending 
before the ALJ'' in current Sec.  405.1104(a) with an appeal that 
``continues to be pending with OMHA'' in proposed Sec.  405.1016(f)(1) 
to be inclusive of situations in which the appeal is assigned to an ALJ 
or attorney adjudicator, or not yet assigned. We are also proposing 
that a written request to escalate an appeal to the Council would be 
filed with OMHA to allow OMHA to provide a central filing option for 
escalation requests. Current Sec.  405.1106(b) requires that the 
appellant send a copy of the escalation request to the other parties 
and failing to do so tolls the Council's adjudication deadline set 
forth in Sec.  405.1100 until the other parties to the hearing have 
received notice. As discussed in section III.A.5.c below, we are 
proposing to revise Sec.  405.1106(b) to require that the request for 
escalation be sent to other parties who were sent a copy of the QIC 
reconsideration. Therefore, we are also proposing at Sec.  
405.1016(f)(1) that the appellant would send a copy of the escalation 
request to the other parties who were sent a copy of the QIC 
reconsideration so appellants would be aware of the requirement and 
which parties must be sent a copy of the escalation request.
    Current Sec.  405.1104(b) describes the escalation process and 
states if the ALJ is not able to issue a decision, dismissal order, or 
remand order within the time period set for in paragraph (a)(2) of the 
section (later of 5 calendar days of receiving the request for 
escalation or 5 calendar days from the end of the applicable 
adjudication period set forth in Sec.  405.1016), he or she sends 
notice to the appellant acknowledging receipt of the request for 
escalation and confirming that the ALJ is not able to issue a decision, 
dismissal order, or remand order within the statutory time frame, or if 
the ALJ does not act on a request for escalation within the time period 
set forth in paragraph (a)(2) of the section or does not send the 
required notice to the appellant, the QIC decision becomes the decision 
that is subject to Council review consistent with Sec.  405.1102(a). 
This process has caused confusion for both appellants and adjudicators 
because an initial escalation request must be filed with the ALJ, and 
if the ALJ is unable to issue a decision, dismissal or remand within 5 
calendar days of receiving the escalation request or within 5 calendar 
days from the end of the applicable adjudication period, the appellant 
must file a request for Council review to move the appeal to the 
Council level, which some appellants do not file. This leaves it 
unclear to the ALJ and support staff whether to continue adjudicating 
the appeal after issuing a notice that the ALJ is unable to issue a 
decision, dismissal or remand within 5 calendar days of receiving the 
escalation request. We are proposing in Sec.  405.1016(f)(2) to revise 
the escalation process. Specifically, we are proposing that if an 
escalation request meets the requirements of proposed Sec.  
405.1016(f)(1), and an ALJ or attorney adjudicator is not able to issue 
a decision, dismissal order, or remand within the later of 5 calendar 
days of receiving the request for escalation or 5 calendar days from 
the end of the applicable adjudication period, OMHA (to be inclusive of 
situations in which the appeal is assigned to an ALJ or attorney 
adjudicator, or not yet assigned) would send a notice to the appellant 
stating that an ALJ or attorney adjudicator is not able to issue a 
decision, dismissal order, or remand order within the adjudication 
period set forth in paragraph (a) or (c) of Sec.  405.1016. We also are 
proposing that the notice would state that the QIC reconsideration 
would be the decision that is subject to Council review consistent with 
Sec.  405.1102(a); and the appeal would be escalated to the Council in 
accordance with Sec.  405.1108. OMHA would then forward the case file, 
which would include the file received from the QIC and the request for 
escalation and all other materials filed with OMHA, to the Council. We 
believe that this proposed process would help alleviate the current 
confusion, and would simplify the escalation process for appellants 
because appellants would not have to file a separate request for 
Council review after filing an escalation request with OMHA.
    Currently, invalid escalation requests are not addressed in the 
regulations. We are proposing in Sec.  405.1016(f)(3) to address 
invalid escalation requests. We are proposing that if an ALJ or 
attorney adjudicator determines an escalation request does not meet the 
requirements of proposed Sec.  405.1016(f)(1), OMHA would send a notice 
to the appellant explaining why the request is invalid within 5 
calendar days of receiving the request for escalation. For example, an 
escalation request would be deemed invalid if escalation is not 
available for the appeal, such as appeals of SSA reconsiderations; the 
escalation request is premature because the adjudication period has not 
expired; or the party that filed the escalation request did not file 
the request for hearing. If an ALJ or attorney adjudicator were to 
determine the request for escalation was invalid for a reason that 
could be corrected (for

[[Page 43823]]

example, if the request was premature), the appellant could file a new 
escalation request when the adjudication period expires.
    We are inviting public comments on these proposals. If you choose 
to comment on the proposals in this section, please include the caption 
``Section 405.1016: Escalation of a request for an ALJ hearing'' at the 
beginning of your comment.
iii. Section 423.2016: Time frames for Deciding an Appeal of an IRE 
Reconsideration
    Current Sec.  423.2016 addresses the adjudication time frames for 
requests for hearing filed after an IRE has issued its reconsideration. 
The title of current Sec.  423.2016 states, ``Timeframes for deciding 
an Appeal before an ALJ.'' We are proposing to revise the title of 
Sec.  423.2016 to read ``Time frames for deciding an appeal of an IRE 
reconsideration'' in order to state that the section addresses 
adjudication time frames related to appeals of IRE reconsiderations and 
to accommodate the application of this section to attorney 
adjudicators, as proposed in Section II.B. above, and as discussed 
earlier. We also are proposing to insert ``or attorney adjudicator'' 
after ``ALJ'' throughout proposed Sec.  423.2016 so that an 
adjudication time frame would apply to a request for an ALJ hearing 
following an IRE reconsideration when the request has been assigned to 
an attorney adjudicator, as discussed in section II.B, above.
    Current Sec.  423.2016(a) and (b) explain the adjudication time 
frames for standard and expedited appeals of IRE reconsiderations, 
respectively. However, the current paragraph titles refer to hearings 
and expedited hearings. We are proposing at Sec.  423.2016(a) and (b) 
to retitle the paragraphs to refer to standard appeals and expedited 
appeals because the time frames apply to issuing a decision, dismissal, 
or remand, and are not limited to appeals in which a hearing is 
conducted. Similar to proposed Sec.  405.1016, we are proposing at 
Sec.  423.2016(a) and (b) to remove ``must'' in providing when an ALJ 
or attorney adjudicator issues a decision, dismissal order, or remand 
to the IRE, as appropriate, after the request for hearing is received 
by the office specified in the IRE's notice of reconsideration because 
there may be instances in which a decision, dismissal, or remand cannot 
be issued within the adjudication time frame, though we expect those 
instances to be rare because beneficiary and enrollee appeals are 
generally prioritized by OMHA. In addition, we are proposing in Sec.  
423.2016(a) and (b) to replace references to sending a request to the 
``entity'' specified in the IRE's reconsideration, with the ``office'' 
specified in the IRE's reconsideration notice, to minimize confusion 
and delays in filing requests with OMHA. Similar to proposed Sec.  
405.1016(b)(2), we are proposing at Sec.  423.2016(a)(3) and (b)(6) to 
adopt adjudication time frames for appeals that are remanded by the 
Council. Specifically, we are proposing in Sec.  423.2016(a)(3) that if 
the Council remands a case and the case was subject to an adjudication 
time frame, the remanded appeal would be subject to the same 
adjudication time frame beginning on the date that OMHA receives the 
Council remand to provide enrollees with an adjudication time frame for 
remanded appeals. In Sec.  423.2016(b)(6), we are proposing to require 
that if the standards for an expedited appeal continue to be met after 
the appeal is remanded from the Council, the 10-day expedited time 
frame would apply to an appeal remanded by the Council. If the 
standards for an expedited appeal are no longer met, the adjudication 
time frame for standard appeals would apply because the criteria for an 
expedited hearing are no longer present. Finally, we are proposing at 
Sec.  423.2016(b) to revise the expedited appeal request process to 
permit an ALJ or attorney adjudicator to review a request for an 
expedited hearing, but not require the same ALJ or attorney adjudicator 
to adjudicate the expedited appeal, to provide OMHA with greater 
flexibility to review and assign requests for expedited hearings, and 
help ensure the 10-day adjudication process is completed as quickly as 
the enrollee's health requires. For example, if an attorney adjudicator 
were to review a request for an expedited hearing and determine that 
the standards for an expedited hearing were met, but did not believe a 
decision could be issued without a hearing, the attorney adjudicator 
could provide the enrollee with notice that the appeal would be 
expedited and transfer the appeal to an ALJ for an expedited hearing 
and decision.
    As described in section III.A.3.q below, we are proposing to move 
the provision for waiving the adjudication period from current Sec.  
423.2036(d) to proposed Sec.  423.2016(c) because proposed Sec.  
423.2016 addresses adjudication time frames and we believe the section 
is a better place for discussing adjudication time frame waivers.
    We are proposing that the provisions of proposed Sec.  405.1016(d) 
be adopted in proposed Sec.  423.2016(c) for adjudication period 
waivers and stays of the proceedings ordered by a court or granted by 
an ALJ or attorney adjudicator on motion by an enrollee.
    We are inviting public comments on these proposals. If you choose 
to comment on the proposals in this section, please include the caption 
``Section 423.2016: Time frames for deciding an appeal of an IRE 
reconsideration'' at the beginning of your comment.
i. Submitting Evidence (Sec. Sec.  405.1018 and 423.2018)
    Current Sec. Sec.  405.1018 and 423.2018 address submitting 
evidence before an ALJ hearing is conducted. We are proposing to 
retitle the sections from ``Submitting evidence before the ALJ 
hearing'' to ``Submitting evidence'' because evidence may be submitted 
and considered in appeals for which no hearing is conducted by an ALJ, 
and we believe an attorney adjudicator should be able to consider 
submitted evidence in deciding appeals as proposed in section II.B 
above. For the same reason, we are proposing in Sec.  423.2018 to 
replace the references to ``hearings'' in the heading to paragraph (a) 
and in the introductory text to paragraphs (b) and (c), with 
``appeals.'' We are also proposing to add headings to paragraphs that 
do not currently have headings, for clarity of the matters addressed in 
the paragraphs.
    Current Sec.  405.1018(a) states that, except as provided in this 
section, parties must submit all written evidence they wish to have 
considered at the hearing with the request for hearing (or within 10 
calendar days of receiving the notice of hearing). We are proposing in 
Sec.  405.1018(a) to provide for the submission of other evidence, in 
addition to written evidence, that the parties wish to have considered. 
Other evidence could be images or data submitted on electronic media. 
This revision would also be adopted in proposed Sec.  405.1018(b) and 
Sec.  423.2018(a), (b), and (c). We are also proposing in Sec.  
405.1018(a) to remove ``at the hearing'' so that parties would submit 
all written or other evidence they wish to have considered, and 
consideration of the evidence would not be limited to the hearing. We 
are proposing a corresponding change at proposed Sec.  423.2018(a).
    Current Sec.  405.1018(a) states that evidence must be submitted 
with the request for hearing, or within 10 calendar days of receiving 
the notice of hearing. This provision has caused confusion as to when 
evidence is required to have been submitted

[[Page 43824]]

because current Sec.  405.1014(a)(7) allows an appellant to state in 
the request for hearing that additional evidence will be submitted and 
the date it will be submitted. To reconcile the provisions, we are 
proposing in Sec.  405.1018(a) to provide that parties must submit all 
written or other evidence they wish to have considered with the request 
for hearing, by the date specified in the request for hearing in 
accordance with proposed Sec.  405.1014(a)(2), or if a hearing is 
scheduled, within 10 calendar days of receiving the notice of hearing. 
We also are proposing that these revisions would be adopted in proposed 
Sec.  423.2018(b) and (c).
    Current Sec.  405.1018(b) addresses how the submission of evidence 
impacts the adjudication period, and provides that if evidence is 
submitted later than 10 calendar days after receiving the notice of 
hearing, the period between when the evidence ``was required to have 
been submitted'' and the time it is received does not count towards an 
adjudication period. To simplify the provision, we are proposing at 
Sec.  405.1018(b) that if evidence is submitted later than 10 calendar 
days after receiving the notice of hearing, any applicable adjudication 
period is extended by the number of calendar days in the period between 
10 calendar days after receipt of the notice of hearing and the day the 
evidence is received. This revision would also be adopted in proposed 
Sec.  423.2018(b)(2) and (c)(2), except that in (c)(2), the 
adjudication time frame is affected if the evidence is submitted later 
than 2 calendar days after receipt of the notice of expedited hearing 
because 2 calendar days is the equivalent time frame to submit evidence 
for expedited appeals before the adjudication period is affected under 
current Sec.  423.2018.
    Current Sec.  405.1018(c) addresses new evidence, and is part of 
the implementation of section 1869(b)(3) of the Act, which precludes a 
provider or supplier from introducing evidence after the QIC 
reconsideration unless there is good cause that prevented the evidence 
from being introduced at or before the QIC's reconsideration. These 
provisions, which provide for the early submission of evidence, allow 
adjudicators to obtain evidence necessary to reach the correct decision 
as early in the appeals process as possible. We are proposing to 
incorporate current Sec.  405.1018(c), which requires a provider, 
supplier, or beneficiary represented by a provider or supplier that 
wishes to introduce new evidence to submit a statement explaining why 
the evidence was not previously submitted to the QIC, or a prior 
decision-maker, in proposed Sec.  405.1018(c)(1). However, current 
Sec.  405.1018 does not address the consequences of not submitting the 
statement. The statute sets a bar to introducing new evidence, and the 
submitting party must establish good cause by explaining why the 
evidence was not previously submitted to the QIC, or a prior decision-
maker. However, when a provider or supplier, or beneficiary represented 
by a provider or supplier, fails to include the required statement, 
OMHA ALJs and staff spend time seeking out the explanation and 
following up with parties to fulfill their obligation. Thus, we are 
proposing to revise Sec.  405.1018(c)(2) to state that if the provider 
or supplier, or beneficiary represented by a provider or supplier fails 
to include the statement explaining why the evidence was not previously 
submitted, the evidence would not be considered. Because only the 
enrollee is a party to a Part D appeal, there is no corresponding 
provision in proposed Sec.  423.2016.
    We are inviting public comments on these proposals. If you choose 
to comment on the proposals in this section, please include the caption 
``Submitting evidence'' at the beginning of your comment.
j. Time and Place for a Hearing Before an ALJ (Sec. Sec.  405.1020 and 
423.2020)
    As the ALJ hearing function transitioned from SSA, where hearings 
could be held at over 140 hearing sites nation-wide, to OMHA with four 
field offices, OMHA became one of the first agencies to use video-
teleconferencing (VTC) as the default mode of administrative hearings. 
The effective use of VTC mitigated OMHA's reduced geographic presence, 
and allowed OMHA to operate more efficiently and at lower cost to the 
American taxpayers. However, the preference of most appellants quickly 
turned to hearings conducted by telephone. In FY 2015, over 98% of 
hearings before OMHA ALJs were conducted by telephone. Telephone 
hearings provide parties and their representatives and witnesses with 
the opportunity to participate in the hearing process with minimal 
disruption to their day, and require less administrative burden at even 
lower cost to the American taxpayers than hearings conducted by VTC. 
OMHA ALJs also prefer telephone hearings in most instances, because 
they allow more hearings to be conducted without compromising the 
integrity of the hearing. However, when the ALJ conducting the hearing 
believes visual interaction is necessary for a hearing, he or she may 
conduct a VTC hearing, and when special circumstances are presented, 
ALJs may conduct in-person hearings.
    Despite the shift in preferences for most appellants to telephone 
hearings, current Sec.  405.1020 still makes VTC the default mode of 
hearing, with the option to offer a telephone hearing to appellants. In 
fact, some appellants have required the more expensive VTC hearing even 
when their representative is presenting only argument and no testimony 
is being offered. We believe this is inefficient and results in wasted 
time and resources that could be invested in adjudicating additional 
appeals, and unnecessarily increases the administrative burdens and 
costs on the government for conducting a hearing with little to no 
discernable benefit to the parties in adjudicating denials of items or 
services that have already been furnished. Based on these 
considerations, we are proposing that a telephone hearing be the 
default method, unless the appellant is an unrepresented beneficiary. 
We believe this balances the costs and administrative burdens with the 
interests of the parties, recognizing that unrepresented beneficiaries 
may have an increased need and desire to visually interact with the 
ALJ.
    We are proposing in 405.1020(b) to provide two standards for 
determining how appearances are made, depending on whether appearances 
are by unrepresented beneficiaries or by individuals other than 
unrepresented beneficiaries. The provisions of current Sec.  
405.1020(b) would be incorporated into proposed Sec.  405.1020(b)(1) 
and revised to be specific to an appearance by an unrepresented 
beneficiary who files a request for hearing. We are proposing in 
subsection (b)(1) that the ALJ would direct that the appearance of an 
unrepresented beneficiary who filed a request for hearing be conducted 
by VTC if the ALJ finds that VTC technology is available to conduct the 
appearance, unless the ALJ finds good cause for an in-person 
appearance. As in the current rule, we also are proposing in Sec.  
405.1020(b)(1) to allow the ALJ to offer to conduct a telephone hearing 
if the request for hearing or administrative record suggests that a 
telephone hearing may be more convenient to the unrepresented 
beneficiary. The current standard for determining whether an in-person 
hearing should be conducted involves a finding that VTC technology is 
not available or special or extraordinary circumstances exist. Because, 
absent special or extraordinary circumstances, a hearing could still be 
conducted by telephone if VTC technology were unavailable, we are 
proposing that the standard for an in-

[[Page 43825]]

person hearing be revised to state that VTC or telephone technology is 
not available or special or extraordinary circumstances exist, and the 
determination would be characterized as finding good cause for an in-
person hearing, to align with current Sec.  405.1020(i)(5), which 
provides for granting a request for an in-person hearing on a finding 
of good cause. We also are proposing in Sec. Sec.  405.1020(b)(1) and 
405.1020(i)(5) to replace the reference to obtaining the concurrence of 
the ``Managing Field Office ALJ'' with the ``Chief ALJ or designee.'' 
The position of the Managing Field Office ALJ became what is now an 
Associate Chief ALJ, see 80 FR 2708, and using ``Chief ALJ or 
designee'' would provide OMHA with the flexibility to designate the 
appropriate individual regardless of future organizational changes. We 
are proposing to adopt these revisions in proposed Sec. Sec.  
423.2020(b)(1), for appearances by unrepresented enrollees and 
423.2020(i)(5), for when an ALJ may grant a request for an in-person 
hearing. We are also proposing in Sec.  405.1020(b)(1) to replace 
``videoteleconferencing,'' with ``video-teleconferencing,'' for 
consistency with terminology used in Sec. Sec.  405.1000, 405.1036, 
423.2000, 423.2020 and 423.2036.
    Proposed Sec.  405.1020(b)(2) addresses appearances by an 
individual other than an unrepresented beneficiary who files a request 
for hearing. We are proposing in Sec.  405.1020(b)(2) that the ALJ 
would direct that those individuals appear by telephone, unless the ALJ 
finds good cause for an appearance by other means. Further, we are 
proposing in Sec.  405.1020(b)(2) that the ALJ may find good cause for 
an appearance by VTC if he or she determines that VTC is necessary to 
examine the facts or issues involved in the appeal. Also, we are 
proposing that the ALJ, with the concurrence of the Chief ALJ or 
designee, may find good cause that an in-person hearing should be 
conducted if VTC and telephone technology are not available, or special 
or extraordinary circumstances exist. We are proposing to adopt these 
revisions in Sec.  423.2020(b)(2) for appearances by represented 
enrollees, which is more specific than proposed Sec.  405.1020(b)(2) 
because only enrollees are parties to appeals under part 423, subpart 
U, and the provisions of subsection (b)(2) would apply only to 
appearances by represented enrollees.
    Current Sec.  405.1020(c)(1) states that the ALJ sends a notice of 
hearing. This has caused confusion as to whether the ALJ must 
personally sign the notice, or whether it can be sent at the direction 
of the ALJ. We believe that the notice may be sent at the direction of 
the ALJ, and requiring an ALJ signature adds an unnecessary step in the 
process of issuing the notice. Therefore, we are proposing in Sec.  
405.1020(c)(1) that a notice of hearing be sent without further 
qualification, and to let other provisions indicate the direction that 
is necessary from the ALJ in order to send the notice, such as Sec.  
405.1022(c)(1), which provides that the ALJ sets the time and place of 
the hearing. We are proposing to adopt these provisions in Sec.  
423.2020(a)(1).
    Current Sec.  405.1020(c)(1) also requires that the notice of 
hearing be sent to the parties who filed an appeal or participated in 
the reconsideration, any party who was found liable for the services at 
issue subsequent to the initial determination, and the QIC that issued 
the reconsideration. However, there are instances in which a party who 
does not meet the criteria may face liability because the ALJ may 
consider a new issue based on a review of the record. To address this, 
we are proposing in Sec.  405.1020(c)(1) to add that a party that may 
be found liable based on a review of the record must be sent a notice 
of hearing. In addition, current Sec.  405.1020 does not address 
notices of hearing sent to CMS or a non-QIC contractor. Currently, ALJs 
may also send a notice of hearing to CMS or a contractor when the ALJ 
believes their input as a participant or party may be beneficial. We 
are proposing in Sec.  405.1020(c)(1) that the notice of hearing also 
be sent to CMS or a contractor that the ALJ believes would be 
beneficial to the hearing. We are not proposing any corresponding 
revisions to current Sec.  423.2020(c)(1) because only enrollees are 
parties to appeals under part 423, subpart U.
    OMHA ALJs have expressed concern that parties and representatives 
who appear at a hearing with multiple individuals and witnesses who 
were not previously identified, complicate and slow the hearing 
process. While a party or representative has considerable leeway in 
determining who will attend the hearing or be called as a witness, 
prior notice of those individuals is necessary for the ALJs to schedule 
adequate hearing time, manage their dockets, and conduct the hearing. 
To address these concerns, we are proposing at Sec.  405.1020(c)(2)(ii) 
to add a requirement to specify the individuals from the entity or 
organization who plan to attend the hearing if the party or 
representative is an entity or organization, and at subsection 
(c)(2)(iii) to add a requirement to list the witnesses who will be 
providing testimony at the hearing, in the response to the notice of 
hearing. We also are proposing to consolidate the provisions in current 
Sec.  405.1020(c)(2)(i) and (c)(2)(ii) in proposed Sec.  
405.1020(c)(2)(i) to simplify the provisions related to the current 
requirements for replying to the notice of hearing. Thus, proposed 
subsection (c)(2)(i) would require all parties to the ALJ hearing to 
reply to the notice by acknowledging whether they plan to attend the 
hearing at the time and place proposed in the hearing, or whether they 
object to the proposed time and/or place of the hearing. We are 
proposing at Sec.  423.2020(c)(2) to adopt corresponding revisions for 
an enrollee's or his or her representative's reply to the notice of 
hearing.
    We also are proposing in Sec.  405.1020(c)(2) to remove the 
provision for CMS or a contractor that wishes to participate in the 
hearing to reply to the notice of hearing in the same manner as a party 
because a non-party may not object to the proposed time and place of 
the hearing, or present witnesses. Instead, we are proposing in Sec.  
405.1020(c)(3) to require CMS or a contractor that wishes to attend the 
hearing as a participant to reply to the notice of hearing by 
acknowledging whether it plans to attend the hearing at the time and 
place proposed in the notice of hearing, and specifying who from the 
entity plans to attend the hearing. We are proposing at Sec.  
423.2020(c)(3) to adopt corresponding revisions for CMS', the IRE's, or 
the Part D plan sponsor' reply to the notice of hearing when the entity 
requests to attend the hearing as a participant.
    In discussing a party's right to waive a hearing, current Sec.  
405.1020(d) states that a party may waive the right to a hearing and 
request that the ALJ issue a decision based on the written evidence in 
the record. In light of proposed Sec.  405.1038(b), which would allow 
attorney adjudicators to issue decisions in appeals that do not require 
hearings on the record without an ALJ conducting a hearing in certain 
situations, we are proposing in Sec.  405.1020(d) to state that a party 
also may waive the right to a hearing and request a decision based on 
the written evidence in the record in accordance with Sec.  
405.1038(b), but an ALJ may require the parties to attend a hearing if 
it is necessary to decide the case. We are proposing at Sec.  
423.2020(d) to adopt corresponding revisions for an enrollee to waive 
his or her right to a hearing and request a decision based on the 
written evidence in the record in accordance with Sec.  423.2038(b), 
but an ALJ could require the enrollee to attend a hearing if it is 
necessary to decide the case. These references would direct readers to

[[Page 43826]]

the section that provides the authority for a decision based on the 
written record, which would provide them with a complete explanation of 
when the authority may be used and notify them that an ALJ or attorney 
adjudicator may issue the decision.
    In addressing the ALJ's authority to change the time or place of 
the hearing if the party has good cause to object, current Sec.  
405.1020(e) requires a party to make the request to change the time or 
place of the hearing in writing. However, on occasion, a party may need 
to request a change on the day prior to, or the day of a hearing due to 
an emergency, such as a sudden illness or injury, or inability to get 
to a site for the hearing. In this circumstance, we believe an oral 
request should be permitted. Therefore, we are proposing in Sec.  
405.1020(e)(3) that the request must be in writing, except that a party 
may orally request that a hearing be rescheduled in an emergency 
circumstance the day prior to or day of the hearing, and the ALJ must 
document the oral request in the administrative record. We are 
proposing at Sec.  423.2020(e)(3) to adopt a corresponding provision 
for an enrollee to orally request a rescheduled standard hearing, and 
to modify the documentation requirement, which is currently limited to 
documenting oral requests made for expedited hearings, to include all 
oral objections.
    In addition, current Sec. Sec.  405.1020(e)(4) and 423.2020(e)(4), 
which explain the ALJ may change the time or place of the hearing if 
the party has good cause, contain a parenthetical that references the 
procedures that an ALJ follows when a party does not respond to a 
notice of hearing and fails to appear at the time and place of the 
hearing. The parenthetical does not appear to address or assist in 
understanding the circumstances covered by current Sec. Sec.  
405.1020(e)(4) and 423.2020(e)(4), and we, therefore, are proposing to 
remove the parenthetical from the respective sections.
    Current Sec. Sec.  405.1020(g)(3) and 423.2020(g)(3) provide a list 
of examples of circumstances a party might give for requesting a change 
in the time or place of the hearing. We have heard from ALJs and 
stakeholders that it would be helpful to also include the following two 
additional examples: (1) The party or representative has a prior 
commitment that cannot be changed without significant expense, in order 
to account for circumstances in which travel or other costly events may 
conflict with the time and place of a hearing, which the ALJ may 
determines warrants good cause for changing the time or place of the 
hearing; and (2) the party or representative asserts that he or she did 
not receive the notice of hearing and is unable to appear at the 
scheduled time and place, which the ALJ may determine warrants good 
cause for changing the time or place of the hearing. We are proposing 
in Sec. Sec.  405.1020(g)(3)(vii) and (viii), and 423.1020(g)(3)(vii) 
and (viii) to add these two examples to address these circumstances. We 
believe these additional examples would provide greater flexibility in 
the appeals process and better accommodate the needs of appellants.
    We are proposing in Sec. Sec.  405.1020(h) and 423.2020(h) to 
revise the references to the adjudication ``deadline'' with references 
to the adjudication ``period,'' for consistency in terminology with the 
specified cross-references.
    We are proposing revisions to Sec.  405.1020(i) to align the 
provision with proposed Sec.  405.1020(b). We are proposing in Sec.  
405.1020(i) that if an unrepresented beneficiary who filed the request 
for hearing objects to a VTC hearing or to the ALJ's offer to conduct a 
hearing by telephone, or if a party other than an unrepresented 
beneficiary who filed the request for hearing objects to a telephone or 
VTC hearing, the party must notify the ALJ at the earliest possible 
opportunity before the time set for the hearing and request a VTC or 
in-person hearing. The party would be required to state the reason for 
the objection and the time and/or place that he or she wants an in-
person or VTC hearing to be held, and the request must be in writing. 
We are proposing in Sec.  405.1020(i)(4) to incorporate the current 
Sec.  405.1020(i)(4) provision that requires the appeal to be 
adjudicated within the time frame specified in Sec.  405.1016 if a 
request for an in-person or VTC hearing is granted unless the party 
waives the time frame in writing. However, we are proposing at Sec.  
405.1020(i)(4) to revise the language to more accurately state that the 
ALJ issues a ``decision, dismissal, or remand to the QIC,'' rather than 
just a ``decision,'' within the adjudication time frame specified in 
Sec.  405.1016. We are proposing revisions to Sec.  423.2020(i) to 
align the provision with proposed Sec.  423.2020(b). We are proposing 
in Sec.  423.2020(i) that if an unrepresented enrollee who filed the 
request for hearing objects to a VTC hearing or to the ALJ's offer to 
conduct a hearing by telephone, or if a represented enrollee who filed 
the request for hearing objects to a telephone or VTC hearing, the 
enrollee or representative must notify the ALJ at the earliest possible 
opportunity before the time set for the hearing and request a VTC or 
in-person hearing. The enrollee would be required to state the reason 
for the objection and the time and/or place that he or she wants an in-
person or VTC hearing to be held. We are proposing in Sec.  
423.2020(i)(4) to incorporate the current Sec.  423.2020(i)(4) 
provision with some modifications so that the appeal would be 
adjudicated within the time frame specified in Sec.  423.2016 if a 
request for an in-person or VTC hearing is granted unless the party 
waives the time frame in writing. We are proposing at Sec.  
423.2020(i)(4) to revise the language to more accurately state that the 
ALJ issues a ``decision, dismissal, or remand to the IRE,'' rather than 
just a ``decision,'' within the adjudication time frame specified in 
Sec.  405.1016 and to include requests for VTC hearings as well as 
requests for in-person hearings. In addition, we are proposing at 
Sec. Sec.  405.1020(i)(5) and 423.2020(i)(5) to provide that upon a 
finding of good cause, a hearing would be rescheduled at a time and 
place when the party may appear in person or by VTC, to account for 
objections to VTC hearings as well as objections to telephone hearings 
or offers to conduct a hearing via telephone. We are also proposing to 
replace ``concurrence of the Managing Field Office ALJ'' with 
``concurrence of the Chief ALJ or a designee'' because the position of 
Managing Field Office ALJ was replaced by the position of Associate 
Chief ALJ (80 FR 2708) and providing a more general reference would 
provide greater flexibility in the future as position titles change.
    Current Sec. Sec.  405.1020 and 423.2020 do not address what occurs 
when the ALJ changes the time or place of the hearing. We are proposing 
at Sec.  405.1020(j) to add a provision titled ``Amended notice of 
hearing'' to clarify that, if the ALJ changes or will change the time 
and/or place of the hearing, an amended notice of hearing must be sent 
to all of the parties who were sent a copy of the notice of hearing and 
CMS or its contractors that elected to be a participant or party to the 
hearing, in accordance with the procedures of Sec.  405.1022(a), which 
addresses issuing a notice of hearing. We are proposing at Sec.  
423.2020(j) to add a provision to clarify that, if the ALJ changes or 
will change the time and/or place of the hearing, an amended notice of 
hearing must be sent to the enrollee and CMS, the IRE, and/or the Part 
D plan sponsor in accordance with the procedures of Sec.  423.2022(a), 
which addresses issuing a notice of hearing. These would help ensure 
that if changes are made to the time or place of the hearing, a new

[[Page 43827]]

notice is issued or waivers are obtained in a consistent manner.
    We are inviting public comments on these proposals. If you choose 
to comment on the proposals in this section, please include the caption 
``Time and place for a hearing before an ALJ'' at the beginning of your 
comment.
k. Notice of a Hearing Before an ALJ and Objections to the Issues 
(Sec. Sec.  405.1022, 405.1024, 423.2022, and 423.2024)
    Current Sec.  405.1022(a) provides that a notice of hearing will be 
mailed or personally served to the parties and other potential 
participants, but a notice is not sent to a party who indicates in 
writing that it does not wish to receive the notice. Current Sec.  
423.2022(a) provides that a notice of hearing will be mailed or 
otherwise transmitted, or personally served, unless the enrollee or 
other potential participant indicates in writing that he or she does 
not wish to receive the notice. However, currently Sec.  405.1022(a) is 
limiting because it does not contemplate transmitting the notice by 
means other than mail or personal service even though technologies 
continue to develop and notice could be provided by secure email or a 
secure portal. Also, notices must be sent in accordance with any OMHA 
procedures that apply, such as procedures to protect personally 
identifiable information. In addition, the exception in current Sec.  
405.1022(a) does not contemplate a scenario in which a potential 
participant indicates that it does not wish to receive the notice, as 
is provided for in current Sec.  423.2022(a). We are proposing in 
Sec. Sec.  405.1022(a) and 423.2022(a) to address these issues and 
align the sections by providing that a notice of hearing would be 
mailed or otherwise transmitted in accordance with OMHA procedures, or 
personally served, except to a party or other potential participant who 
indicates in writing that he or she does not wish to receive the 
notice.
    Current Sec. Sec.  405.1022(a) and 423.2022(a) provide that a 
notice of hearing does not have to be sent to a party who indicates in 
writing that it does not wish to receive the notice and that the notice 
is mailed or served at least 20 calendar days (for Parts A and B and 
for non-expedited Part D hearings), or 3 calendar days (for expedited 
Part D hearings) before the hearing. The provisions do not address the 
situation where a party wishes to receive the notice, but agrees to the 
notice being mailed fewer than 20 calendar days (or 3 calendar days if 
expedited) before the hearing, which may be necessary to accommodate an 
appellant's request to conduct a hearing in fewer than 20 or 3 calendar 
days. We are proposing to revise Sec. Sec.  405.1022(a) and 423.2022(a) 
to address this situation by providing the notice is mailed, 
transmitted, or served at least 20 calendar days (or 3 calendar days if 
expedited) before the hearing unless the recipient agrees in writing to 
the notice being mailed, transmitted, or served fewer than 20 calendar 
days (or 3 calendar days if expedited) before the hearing. However, we 
note that like a recipient's waiver of receiving a notice of hearing, a 
recipient's waiver of the requirement to mail, transmit, or serve the 
notice at least 20 or 3 calendar days (as applicable) before the 
hearing would only be effective for the waiving recipient and does not 
affect the rights of other recipients.
    Current Sec.  405.1022(b)(1) requires a notice of hearing to 
contain a statement of the specific issues to be decided and inform the 
parties that they may designate a person to represent them during the 
proceedings. These statements of issues take time to develop, and 
current Sec.  405.1032, which addresses the issues before an ALJ, 
provides that the issues before the ALJ are all the issues brought out 
in the initial determination, redetermination, or reconsideration that 
were not decided entirely in a party's favor. Current Sec.  405.1032 
also permits an ALJ to consider a new issue at the hearing, if notice 
of the new issue is provided to all parties before the start of the 
hearing. To streamline the notice of hearing, rather than require the 
notice of hearing to contain a statement of the specific issues to be 
decided, we are proposing in Sec.  405.1022(b)(1) to require the notice 
of hearing to include a general statement putting the parties on notice 
that the issues before the ALJ include all of the issues brought out in 
the initial determination, redetermination, or reconsideration that 
were not decided entirely in a party's favor, for the claims specified 
in the request for hearing. This is consistent with the standard for 
determining the issues before the ALJ in proposed Sec.  405.1032(a). 
However, we also are proposing in Sec.  405.1022(b)(1) that the notice 
of hearing also would contain a statement of any specific new issues 
that the ALJ will consider in accordance with Sec.  405.1032 to help 
ensure the parties and potential participants are provided with notice 
of any new issues of which the ALJ is aware at the time the notice of 
hearing is sent, and can prepare for the hearing accordingly. For 
example, if in the request for hearing an appellant raises an issue 
with the methodology used to sample claims and extrapolate an 
overpayment, and that issue had not been brought out in the initial 
determination, redetermination, or reconsideration, the issue would be 
a new issue and the specific issue would be identified in the notice of 
hearing. To accommodate proposed Sec.  405.1022(b)(1), we are proposing 
that the portion of current Sec.  405.1022(b)(1) that requires the 
notice of hearing to inform the parties that they may designate a 
person to represent them during the proceedings would be re-designated 
as Sec.  405.1022(b)(2), and current subsections (b)(2), (b)(3), and 
(b)(4) would be re-designated as subsections (b)(3), (b)(4), and 
(b)(5), respectively. We are proposing at Sec.  423.2022(b) to adopt 
corresponding revisions for notice information in part 423, subpart U 
proceedings.
    Current Sec.  405.1022(c)(1) provides that if the appellant, any 
other party to the reconsideration to whom the notice of hearing was 
sent, or their representative does not acknowledge receipt of the 
notice of hearing, the ALJ hearing office attempts to contact the party 
for an explanation. We are proposing to replace ``ALJ hearing office'' 
with ``OMHA'' because OMHA is the responsible entity.
    Current Sec.  405.1022(c)(2) provides that if a party states that 
he or she did not receive the notice of hearing, an amended notice is 
sent to him or her. The reference to an amended notice has caused 
confusion, as the original notice does not need to be amended unless 
the hearing is rescheduled. We are proposing in Sec.  405.1022(c)(2) to 
remove the reference to an ``amended'' notice of hearing and provide 
that a copy of the notice of hearing is sent to the party. However, if 
a party cannot attend the hearing, we are proposing in new Sec.  
405.1022(c)(3) that the party may request that the ALJ reschedule the 
hearing in accordance with proposed Sec.  405.1020(e), which discusses 
a party's objection to the time and place of hearing. We are proposing 
at Sec.  423.2022(c) to adopt corresponding revisions for providing a 
copy of the notice of hearing if the enrollee did not acknowledge it 
and states that he or she did not receive it in part 423, subpart U 
proceedings.
    Current Sec.  405.1022(c)(2) provides that if a party did not 
receive the notice of hearing, a copy of the notice may be sent by 
certified mail or email, if available. Current Sec.  423.2022(c)(2) 
provides an additional option to send the copy by fax. However, use of 
email to send documents that contain a beneficiary's or enrollee's 
personally identifiable information is not currently permitted by OMHA 
policy, and faxes

[[Page 43828]]

must be sent in accordance with procedures to protect personally 
identifiable information. We are proposing in Sec. Sec.  405.1022(c)(2) 
and 423.2022(c)(2) to remove the references to using email and fax, and 
to add that a notice may be sent by certified mail or other means 
requested by the party and in accordance with OMHA procedures. This 
would provide the flexibility to develop alternate means of 
transmitting the request and allow OMHA to help ensure necessary 
protections are in place to comply with HHS information security 
policies. Finally, the parenthetical in current Sec. Sec.  
405.1022(c)(2) and 423.2022(c)(2) is not applicable. We believe it was 
attempting to cross-reference the provision related to requesting a 
rescheduled hearing. Therefore, we are proposing in Sec. Sec.  
405.1022(c)(2) and 423.2022(c)(2) to remove the parenthetical. As 
discussed above, proposed Sec. Sec.  405.1022(c)(3) and 423.2022(c)(3) 
would address the option for a party to request a rescheduled hearing 
and contain the correct cross-reference.
    Current Sec.  405.1024 sets forth the provision regarding 
objections by a party to the issues described in the notice of hearing. 
Current Sec.  405.1024(b) requires a party to send a copy of its 
objection to the issues to all other parties to the appeal. We are 
proposing to revise Sec.  405.1024(b) to provide that the copy is only 
sent to the parties who were sent a copy of the notice of hearing, and 
CMS or a contractor that elected to be a party to the hearing, because 
we believe sending a copy of the objection to additional parties is 
unnecessary and causes confusion for parties who were not sent a copy 
of the notice of hearing. No corresponding change is proposed in Sec.  
423.2024 because only the enrollee is a party.
    Current Sec.  405.1024(c) states that an ALJ makes a decision on 
the objection to the issues either in writing or at the hearing. We are 
proposing to revise Sec.  405.1024(c) to add the option for an ALJ to 
make a decision on the objections at a prehearing conference, which is 
conducted to facilitate the hearing, as well as at the hearing. We 
believe this added flexibility would allow ALJs to discuss the 
objections with the parties and make a decision on the record before 
the hearing at the prehearing conference. However, we note that the 
ALJ's decision on an objection to the issues at a prehearing conference 
pursuant to proposed Sec.  405.1024(c) would not be subject to the 
objection process for a prehearing conference order under Sec.  
405.1040(d). A decision on an objection to the issues is not an 
agreement or action resulting from the prehearing conference, but 
rather the ALJ's decision on a procedural matter for which the ALJ has 
discretion, and we do not believe the parties should have a right of 
veto through the prehearing conference order objection process. We also 
are proposing at Sec.  423.2024(c) to adopt a corresponding revision 
for a decision on an objection to the issues in part 423, subpart U 
proceedings.
    We are inviting public comments on these proposals. If you choose 
to comment on the proposals in this section, please include the caption 
``Notice of a hearing before an ALJ and objections to the issue'' at 
the beginning of your comment.
l. Disqualification of the ALJ or Attorney Adjudicator (Sec. Sec.  
405.1026 and 423.2026)
    Current Sec.  405.1026 provides a process for a party to request 
that an ALJ disqualify himself or herself from an appeal, or for an ALJ 
to disqualify himself or herself from an appeal on the ALJ's own 
motion. We are proposing to revise Sec.  405.1026 to replace the 
current references to conducting a hearing with references to 
adjudicating an appeal, to make it is clear that disqualification is 
not limited to ALJs or cases where a hearing is conducted to help 
ensure that an attorney adjudicator, as proposed in section II.B above, 
also cannot adjudicate an appeal if he or she is prejudiced or partial 
to any party, or has any interest in the matter pending for decision. 
Current Sec.  405.1026(b) requires that, if a party objects to the ALJ 
who will conduct the hearing, the party must notify the ALJ within 10 
calendar days of the date of the notice of hearing. The ALJ considers 
the party's objections and decides whether to proceed with the hearing 
or withdraw. However, the current rule does not address appeals for 
which no hearing is scheduled and/or no hearing will be conducted. 
Therefore, we are proposing to revise Sec.  405.1026(b) to require that 
if a party objects to the ALJ or attorney adjudicator assigned to 
adjudicate the appeal, the party must notify the ALJ within 10 calendar 
days of the date of the notice of hearing if a hearing is scheduled, or 
the ALJ or attorney adjudicator any time before a decision, dismissal 
order, or remand order is issued if no hearing is scheduled. We also 
are proposing to revise Sec.  405.1026(c) to state that an ALJ or 
attorney adjudicator is ``assigned'' to adjudicate an appeal, rather 
than ``appointed,'' for consistency in terminology, and to replace 
``hearing decision'' with ``decision or dismissal'' because not all 
decisions are issued following a hearing and an appellant may have 
objected in an appeal that was dismissed, for which review may also be 
requested from the Council. In addition, we are proposing to add ``if 
applicable'' in discussing that the Council would consider whether a 
new hearing is held because not all appeals may have had or require a 
hearing. We are proposing at Sec.  423.2026 to adopt corresponding 
revisions for disqualification of an ALJ or attorney adjudicator in 
part 423, subpart U proceedings.
    Current Sec.  405.1026 does not address the impact of a party 
objection and adjudicator's withdrawal on an adjudication time frame. 
The withdrawal of an adjudicator and re-assignment of an appeal will 
generally cause a delay in adjudicating the appeal. We are proposing in 
new Sec.  405.1026(d) that if the party objects to the ALJ or attorney 
adjudicator, and the ALJ or attorney adjudicator subsequently 
withdrawals from the appeal, any applicable adjudication time frame 
that applies is extended by 14 calendar days. This would allow the 
appeal to be re-assigned and for the new adjudicator to review the 
appeal. We are proposing at Sec.  423.2026(d) to adopt a corresponding 
provision for the effect of a disqualification of an adjudicator on an 
adjudication time frame in part 423, subpart U proceedings, but are 
proposing that if an expedited hearing is scheduled, the time frame is 
extended by 2 calendar days, to balance the need for the newly assigned 
adjudicator to review the appeal, and the enrollee's need to receive a 
decision as quickly as possible.
    We are inviting public comments on these proposals. If you choose 
to comment on the proposals in this section, please include the caption 
``Disqualification of the ALJ or attorney adjudicator'' at the 
beginning of your comment.
m. Review of Evidence Submitted by the Parties (Sec.  405.1028)
    Current Sec.  405.1028 addresses the prehearing review of evidence 
submitted to the ALJ. We are proposing to revise the title of Sec.  
405.1028 to reflect that the regulation would more broadly apply to the 
review of evidence submitted by the parties because a hearing may not 
be conducted and an attorney adjudicator would review evidence in 
deciding appeals as proposed in section II.B above.
    Proposed Sec.  405.1028(a) would incorporate current Sec.  
405.1028(a) to address new evidence. Current Sec.  405.1028(a) states 
that after a hearing is requested but before it is held, the ALJ will 
examine any new evidence

[[Page 43829]]

submitted with the request for hearing (or within 10 calendar days of 
receiving the notice of hearing) as specified in Sec.  405.1018, by a 
provider, supplier, or beneficiary represented by a provider or 
supplier to determine whether there was good cause for submitting 
evidence for the first time at the ALJ level. However, this provision 
and the other provisions in current Sec.  405.1028 do not address the 
review of new evidence when no hearing is conducted for an appeal. 
Therefore, we are proposing to revise Sec.  405.1028(a) to add Sec.  
405.1028(a)(1), (2), (3), and (4), and are proposing in Sec.  
405.1028(a)(1) that after a hearing is requested but before it is held 
by an ALJ (to reinforce that hearings are only conducted by ALJs), or a 
decision is issued if no hearing is held, the ALJ or attorney 
adjudicator would review any new evidence. In addition, we are 
proposing in Sec.  405.1028(a)(1) to remove the duplicative statement 
indicating the review is conducted on ``any new evidence submitted with 
the request for hearing (or within 10 calendar days of receiving the 
notice of hearing) as specified in Sec.  405.1018,'' because Sec.  
405.1018 discusses when evidence may be submitted prior to a hearing 
and, as explained in III.A.3.i above, proposed Sec.  405.1018 would 
revise the language that is duplicated in current Sec.  405.1028. We 
believe that the better approach going forward is simply to reference 
Sec.  405.1018 by indicating that the review is conducted on ``any new 
evidence submitted in accordance with Sec.  405.1018.'' This would 
remind parties that evidence must be submitted in accordance with Sec.  
405.1018, while minimizing confusion on which section is authoritative 
with regard to when evidence may be submitted.
    In a 2012 OIG report on the ALJ hearing process (OEI-02-10-00340), 
the OIG reported concerns regarding the acceptance of new evidence in 
light of the statutory limitation at section 1869(b)(3) of the Act on 
new evidence submitted by providers and suppliers. The OIG concluded 
that the current regulations regarding the acceptance of new evidence 
provide little guidance and only one example of good cause, and 
recommended revising the regulations to provide additional examples and 
factors for ALJs to consider when determining good cause.
    Section 1869(b)(3) of the Act states that a provider or supplier 
may not introduce evidence in any appeal that was not presented at the 
QIC reconsideration unless there is good cause which precluded the 
introduction of such evidence at or before that reconsideration. This 
section presents a Medicare-specific limitation on submitting new 
evidence, and therefore limits the authority of an ALJ to accept new 
evidence under the broader APA provisions (see 5 U.S.C. 556(c)(3) 
(``Subject to published rules of the agency and within its power, 
employees presiding at hearings may- . . . receive relevant evidence . 
. . .'')). Section 1869(b)(3) of the Act also presents a clear intent 
by Congress to limit the submission of new evidence after the QIC 
reconsideration, which must be observed.
    In light of the OIG conclusion and recommendation and to more 
effectively implement section 1869(b)(3) of the Act, we are proposing 
to incorporate current Sec.  405.1028(b) in proposed Sec.  
405.1028(a)(2) on when an ALJ could find good cause for submitting 
evidence for the first time at the OMHA level, and to establish four 
additional circumstances in which good cause for submitting new 
evidence may be found. We are also proposing to permit an attorney 
adjudicator to find good cause because attorney adjudicators would be 
examining new evidence in deciding appeals on requests for an ALJ 
hearing as proposed in section II.B above, and we believe the same 
standard for considering evidence should apply.
    We are proposing in Sec.  405.1028(a)(2)(i) to adopt the example in 
current Sec.  405.1028(b) and provide that good cause is found when the 
new evidence is, in the opinion of the ALJ or attorney adjudicator, 
material to an issue addressed in the QIC's reconsideration and that 
issue was not identified as a material issue prior to the QIC's 
reconsideration.
    We are proposing in Sec.  405.1028(a)(2)(ii) to provide that good 
cause is found when the new evidence is, in the opinion of the ALJ, 
material to a new issue identified in accordance with Sec.  
405.1032(b). This would provide parties with an opportunity to submit 
new evidence to address a new issue that was identified after the QIC's 
reconsideration. However, the authority is limited to ALJs because, as 
discussed in proposed Sec.  405.1032, only an ALJ may raise a new issue 
on appeal.
    We are proposing in Sec.  405.1028(a)(2)(iii) to provide that good 
cause is found when the party was unable to obtain the evidence before 
the QIC issued its reconsideration and the party submits evidence that, 
in the opinion of the ALJ or attorney adjudicator, demonstrates that 
the party made reasonable attempts to obtain the evidence before the 
QIC issued its reconsideration. For example, if specific medical 
records are necessary to support a provider's or supplier's claim for 
items or services furnished to a beneficiary, the provider or supplier 
must make reasonable attempts to obtain the medical records, such as 
requesting records from a beneficiary or the beneficiary's physician 
when it became clear the records are necessary to support the claim, 
and following up on the request. Obtaining medical records, in some 
cases from another health care professional, and submitting those 
records to support a claim for services furnished to a beneficiary is a 
basic requirement of the Medicare program (see sections 1815(a) and 
1833(e) of the Act, and Sec.  424.5(a)(6)), and we expect instances 
where records cannot be obtained in the months leading up to a 
reconsideration should be rare. If the provider or supplier was unable 
to obtain the records prior to the QIC issuing its reconsideration, 
good cause for submitting the evidence after the QIC's reconsideration 
could be found when the ALJ or attorney adjudicator determines that the 
provider or supplier submitted evidence that demonstrates the party 
made reasonable attempts to obtain the evidence before the QIC issued 
its reconsideration.
    We are proposing at Sec.  405.1028(a)(2)(iv) to provide that good 
cause is found when the party asserts that the evidence was submitted 
to the QIC or another contractor and the party submits evidence that, 
in the opinion of the ALJ or attorney adjudicator, demonstrates that 
the new evidence was indeed submitted to the QIC or another contractor 
before the QIC issued the reconsideration. For example, if a provider 
or supplier submitted evidence to the QIC or another contractor and 
through administrative error, the evidence is not associated with the 
record that is forwarded to OMHA, good cause may be found when the ALJ 
or attorney adjudicator determines that the provider or supplier 
submitted evidence that demonstrates the new evidence was submitted to 
the QIC or another contractor before the QIC issued the 
reconsideration.
    Finally, we are proposing at Sec.  405.1028(a)(2)(v) to provide 
that in circumstances not addressed in proposed paragraphs (i) through 
(iv), the ALJ or attorney adjudicator may find good cause for new 
evidence when the ALJ or attorney adjudicator determines the party has 
demonstrated that it could not have obtained the evidence before the 
QIC issued its reconsideration. We expect proposed paragraphs (i) 
through (iv) to cover most circumstances in which a provider or 
supplier attempts to introduce new evidence after the QIC 
reconsideration, but we believe this additional provision is necessary 
to allow for a good cause finding in any

[[Page 43830]]

other circumstance that meets the requirements of section 1869(b)(3) of 
the Act. Paragraph (v) helps ensure that OMHA fulfills the statutory 
requirement by requiring that the ALJ or attorney adjudicator make a 
determination on whether the party could have obtained the evidence 
before the QIC issued its reconsideration.
    To accommodate the new structure of proposed Sec.  405.1028, we are 
proposing that current paragraphs (c) and (d) be re-designated as 
paragraphs (a)(3) and (a)(4), respectively. In addition, we are 
proposing at Sec.  405.1028(a)(4) that notification about whether the 
evidence would be considered or excluded applies only when a hearing is 
conducted, and notification of a determination regarding new evidence 
would be made only to parties and participants who responded to the 
notice of hearing, since all parties may not be sent a copy of the 
notice of hearing or attend the hearing. We note that if a hearing is 
not conducted, whether the evidence was considered or excluded would be 
discussed in the decision, pursuant to proposed Sec.  405.1046(a)(1), 
as discussed in section III.A.3.v below. We also are proposing at Sec.  
405.1028(a)(4) that the ALJ would notify all parties and participants 
whether the new evidence would be considered or is excluded from 
consideration (rather than only whether the evidence will be excluded 
from the hearing) and that this determination would be made no later 
than the start of the hearing, if a hearing is conducted. If evidence 
is excluded, it is excluded from consideration, not just the hearing, 
and evidence may be excluded from consideration even when no hearing is 
conducted. We believe that this would provide greater clarity to 
parties and participants regarding the ALJ's determination with respect 
to new evidence, and the effect of the exclusion of such evidence on 
the proceedings.
    Current Sec.  405.1028 does not address duplicative evidence. 
However, duplicative evidence is a significant challenge for OMHA 
because appellants often submit copies of medical records and other 
submissions that were filed at prior levels of appeal and are in the 
record forwarded to OMHA. While we recognize that appellants want to 
ensure the evidence is in the record and considered, we are also 
mindful that the APA provides that as a matter of policy, an agency 
shall provide for the exclusion of unduly repetitious evidence (see 5 
U.S.C. 556(d)).
    We are proposing in Sec.  405.1028(b) that the ALJ or attorney 
adjudicator may exclude from consideration any evidence submitted by a 
party at the OMHA level that is duplicative of evidence already in the 
record forwarded to OMHA. In addition to establishing a general policy 
for the exclusion of unduly repetitious evidence, this would reduce 
confusion as to which of the multiple copies of records to review, and 
would reduce administrative burden.
    We are inviting public comments on these proposals. If you choose 
to comment on the proposals in this section, please include the caption 
``Review of evidence submitted by the parties'' at the beginning of 
your comment.
n. ALJ Hearing Procedures (Sec. Sec.  405.1030 and 423.2030)
    The APA provides an ALJ with the authority to regulate the course 
of a hearing, subject to the rules of the agency (see 5 U.S.C. 
556(c)(5)). In rare circumstances, OMHA ALJs have encountered a party 
or representative that makes it difficult or impossible for the ALJ to 
regulate the course of a hearing, or for other parties to present their 
side of the dispute. This may occur when a party or representative 
continues to present testimony or argument on a matter that is not 
relevant to the issues before the ALJ, or on a matter for which the ALJ 
believes he or she has sufficient information or on which the ALJ has 
already ruled. This may also occur when a party or representative is 
uncooperative, disruptive, or abusive during the course of the hearing. 
Sections 405.1030 and 423.2030 sets forth the rules that govern ALJ 
hearing procedures. We are proposing to revise Sec. Sec.  405.1030(b) 
and 423.2030(b) to add provisions to address these circumstances in a 
consistent manner that protects the interests of the parties and the 
integrity of the hearing process. To accommodate these proposals, we 
are proposing to re-designate paragraph (b) in both Sec. Sec.  405.1030 
and 423.2030 as paragraph (b)(1), and to be consistent with proposed 
Sec. Sec.  405.1018 and 423.2018, would replace the current language 
stating that an ALJ may accept ``documents that are material to the 
issues'' with ``evidence that is material to the issues,'' because not 
all evidence that may be submitted is documentary evidence (for 
example, photographs).
    We are proposing in Sec.  405.1030(b)(2) to address circumstances 
in which a party or representative continues with testimony and 
argument that are not relevant to the issues before the ALJ or that 
address a matter for which the ALJ believes he or she has sufficient 
information or on which the ALJ has already ruled. In these 
circumstances, the ALJ may limit testimony and/or argument at the 
hearing, and may, at the ALJ's discretion, provide the party or 
representative with an opportunity to submit additional written 
statements and affidavits on the matter in lieu of testimony and/or 
argument at the hearing, within a time frame designated by the ALJ. 
Proposed Sec.  405.1030(b)(2) would allow the ALJ to effectively 
regulate the course of the hearing by providing the ALJ with the clear 
authority to limit testimony and/or argument during the hearing, while 
providing an avenue for the ALJ to allow the testimony and/or argument 
to be entered into the record. We are proposing at Sec.  423.2030(b)(2) 
to adopt a corresponding revision for limiting testimony and argument 
at a hearing, and at the ALJ's discretion, provide an opportunity to 
submit additional written statements and affidavits in part 423, 
subpart U proceedings.
    We are proposing at Sec.  405.1030(b)(3) to address circumstances 
in which a party or representative is uncooperative, disruptive, or 
abusive during the course of the hearing. In these circumstances, we 
are proposing that the ALJ would have the clear authority to excuse the 
party or representative from the hearing and continue with the hearing 
to provide the other parties and participants with the opportunity to 
offer testimony and/or argument. However, in this circumstance, the ALJ 
would be required to provide the excused party or representative with 
an opportunity to submit written statements and affidavits in lieu of 
testimony and/or argument at the hearing. Further, the party also would 
be allowed to request a copy of the audio recording of the hearing in 
accordance with Sec.  405.1042 and respond in writing to any statements 
made by other parties or participants and/or testimony of the witnesses 
at the hearing, within a time frame designated by the ALJ. These 
proposals would allow the ALJ to effectively regulate the course of the 
hearing and balance the excused party's right to present his or her 
case, present rebuttal evidence, and cross-examine the witnesses of 
other parties with allowing the party to submit written statements and 
affidavits. We are proposing at Sec.  423.2030(b)(3) to adopt a 
corresponding revision for excusing an enrollee or representative who 
is uncooperative, disruptive, or abusive during the hearing in part 
423, subpart U proceedings.
    Current Sec.  405.1030(c) addresses evidence that the ALJ 
determines is missing at the hearing, and provides that if the evidence 
is in the possession

[[Page 43831]]

of the appellant, and the appellant is a provider, supplier, or a 
beneficiary represented by a provider or supplier, the ALJ must 
determine whether the appellant had good cause for not producing the 
evidence earlier. We are proposing to revise Sec.  405.1030(c) to add 
that the ALJ must determine whether the appellant had good cause in 
accordance with Sec.  405.1028 for not producing the evidence. Section 
1869(b)(3) of the Act applies to limit submission of all new evidence 
after the QIC reconsideration by a provider or supplier absent good 
cause, and the proposed addition would create consistent application of 
the standards for determining whether there is good cause to admit new 
evidence, regardless of when the evidence is submitted after the QIC 
reconsideration. We are not proposing any corresponding changes to 
current Sec.  423.2030(c) because the limitation on new evidence does 
not apply in part 423, subpart U proceedings.
    Current Sec.  405.1030(d) and (e) discuss what happens if an ALJ 
determines there was or was not good cause for not producing the new 
evidence earlier. Current Sec.  405.1030(d) provides that if the ALJ 
determines that good cause exists, the ALJ considers the evidence in 
deciding the case, and the adjudication period is tolled from the date 
of the hearing to the date that the evidence is submitted. Current 
Sec.  405.1030(e) provides that if the ALJ determines that good cause 
does not exist, the evidence is excluded, with no impact on an 
applicable adjudication period. Current Sec.  405.1030(d) and (e) have 
caused confusion in light of Sec.  405.1018, which indicates that the 
adjudication period will be affected if evidence is submitted later 
than 10 calendar days after receipt of the notice of hearing, unless 
the evidence is submitted by an unrepresented beneficiary. It has also 
potentially created an incentive for appellants to disregard Sec.  
405.1018 because current Sec.  405.1030(b) appears to allow evidence to 
be submitted at the hearing without affecting the adjudication time 
frame; and Sec.  405.1030(c) allows the ALJ to stop a hearing 
temporarily if there is material evidence missing, with the effect of 
tolling the adjudication time frame from the date of the hearing to the 
date the evidence is submitted, if the evidence is in the possession of 
an appellant who is a provider or supplier or beneficiary represented 
by a provider or supplier, and the ALJ finds good cause to admit the 
evidence. In addition, OMHA ALJs have expressed concern that current 
Sec.  405.1030(e) does not affect the adjudication period when an equal 
amount of time is spent reviewing evidence and making a good cause 
determination, regardless of whether good cause is found.
    Therefore, we are proposing to revise Sec.  405.1030(d) to address 
the effect of an evidentiary submission on an adjudication period. We 
are proposing in Sec.  405.1030(d) that any applicable adjudication 
period is extended in accordance with proposed Sec.  405.1018(b) if an 
appellant other than an unrepresented beneficiary submits evidence 
pursuant to proposed Sec.  405.1030(b), which generally allows for 
submission of evidence at the hearing, or proposed Sec.  405.1030(c), 
which specifically addresses evidence that the ALJ determines is 
missing at the hearing. Under proposed Sec.  405.1018(b), any 
adjudication period that applies to the appeal would be extended by the 
number of days starting 10 calendar days after receipt of the notice of 
hearing, and ending when the evidence is submitted, whether it is at 
the hearing pursuant to proposed Sec.  405.1030(b)(1), or at a later 
time pursuant to proposed Sec.  405.1030(c). Proposed Sec.  405.1030(d) 
would provide appellants with an incentive to submit evidence they wish 
to have considered early in the adjudication process, allow the ALJ to 
consider the evidence and effectively prepare for the hearing, and 
minimize any delays in the adjudication process resulting from the late 
introduction of evidence during the hearing process. Proposed Sec.  
405.1030(d) would also remove the potential incentive to disregard 
Sec.  405.1018, and reconcile any inconsistency in the effect of a late 
evidentiary submission on an applicable adjudication period by 
incorporating the Sec.  405.1018 provisions by reference rather than 
establishing a different standard for evidence submitted during the 
course of or after a hearing. We are proposing at Sec.  423.2030(d) to 
adopt a corresponding provision for the effect on an adjudication time 
frame when new evidence is submitted by a represented enrollee in a 
standard appeal, or an unrepresented or represented enrollee in an 
expedited appeal, in accordance with current Sec.  423.2018(b) or (c), 
as applicable.
    Continuing a hearing is referenced in current Sec.  405.1030(c), 
but is not otherwise addressed in part 405, subpart I. We are proposing 
in Sec.  405.1030(e)(1) that a hearing may be continued to a later date 
and that the notice of the continued hearing would be sent in 
accordance with the proposed Sec.  405.1022, except that a waiver of 
the notice of hearing may be made in writing or on the record, and the 
notice of continued hearing would be sent to the parties and 
participants who attended the hearing, and any additional parties or 
potential parties or participants the ALJ determines are appropriate. 
The notice requirement would help ensure that the general hearing 
notice requirements are met for a continued hearing, but allow a waiver 
of the notice of hearing to be made in writing or on the record. We 
believe the added option of waiving the notice of hearing on the record 
in the context of a continued hearing would facilitate scheduling the 
continued hearing when all parties and participants who are in 
attendance at the hearing agree to the continued hearing date, or 
alternatively agree on the record to the notice being mailed, 
transmitted, or served fewer than 20 calendar days before the hearing. 
In addition, proposed Sec.  405.1030(e)(1) would only require that a 
notice of the continued hearing be sent to the participants and parties 
who attended the hearing, but would provide the ALJ with the discretion 
to also send the notice to additional parties, or potential parties or 
participants. We believe that a notice of the continued hearing to a 
party, or potential party or participant, who did not attend the 
hearing is not necessary unless the ALJ determines otherwise based on 
the circumstances of the case. In the event that the appellant 
requested the continuance and an adjudication period applies to the 
appeal, we are proposing in Sec.  405.1030(e)(2) to provide that the 
adjudication period would be extended by the period between the initial 
hearing date and the continued hearing date. We believe an appellant's 
request for a continuance of the hearing is similar to an appellant's 
request to reschedule a hearing, and if the request is granted, the 
adjudication period for the appellant's request for hearing should be 
adjusted accordingly. We are proposing at Sec.  423.2030(e) to adopt 
corresponding provisions for continued hearings in part 423, subpart U 
proceedings.
    On occasion, after a hearing is conducted, ALJs find that 
additional testimony or evidence is necessary to decide the issues on 
appeal, or a procedural matter needs to be addressed. Current Sec.  
405.1030(f) allows an ALJ to reopen a hearing to receive new and 
material evidence pursuant to Sec.  405.986, which requires that the 
evidence (1) was not available or known at the time of the hearing, and 
(2) may result in a different conclusion. However, current Sec.  
405.1030(f) does not provide a mechanism to address procedural matters, 
or to obtain

[[Page 43832]]

additional information through evidence or testimony that may have been 
available at the time of hearing and may result in a different outcome 
but the importance of which was not recognized until after a post-
hearing review of the case. We are proposing in Sec.  405.1030(f)(1) to 
remove the ``reopen'' label and provide for a ``supplemental'' hearing 
rather than reopening the hearing to distinguish it from reopening a 
decision and the standards for reopening a decision. We are also 
proposing that a supplemental hearing may be conducted at the ALJ's 
discretion at any time before the ALJ mails a notice of decision in 
order to receive new and material evidence, obtain additional 
testimony, or address a procedural matter. The ALJ would determine 
whether a supplemental hearing is necessary, and if one is held, the 
scope of the supplemental hearing, including when evidence is presented 
and what issues are discussed. In addition, we are proposing at Sec.  
405.1030(f)(1) that a notice of the supplemental hearing be sent in 
accordance with Sec.  405.1022 to the participants and parties who 
attended the hearing, but would provide the ALJ with the discretion to 
also send the notice to additional parties, or potential parties or 
participants the ALJ determines are appropriate. Similar to the 
proposed notice of a continued hearing explained above, we believe that 
a notice of the supplemental hearing to a party, or potential party or 
participant, who did not attend the hearing is not necessary unless the 
ALJ determines otherwise based on the circumstances of the case. In the 
event that the appellant requested the supplemental hearing and an 
adjudication period applies to the appeal, we are proposing at Sec.  
405.1030(f)(2) to provide that the adjudication period would be 
extended by the period between the initial hearing date and the 
supplemental hearing date. We believe an appellant's request for a 
supplemental hearing is similar to an appellant's request for a 
continuance or to reschedule a hearing, and if the request is granted, 
the adjudication period for the appellant's request for hearing should 
be adjusted accordingly. We are proposing at Sec.  423.2030(f) to adopt 
corresponding provisions for supplemental hearings in part 423, subpart 
U proceedings.
    We are inviting public comments on these proposals. If you choose 
to comment on the proposals in this section, please include the caption 
``ALJ hearing procedures'' at the beginning of your comment.
o. Issues Before an ALJ or Attorney Adjudicator (Sec. Sec.  405.1032 
and 423.2032)
    Current Sec. Sec.  405.1032 and 423.2032 address the issues that 
are before the ALJ. We are proposing to revise the title of the section 
to indicate that the proposed provision also would apply to issues 
before an attorney adjudicator, as proposed in section II.B above, if 
an attorney adjudicator is assigned to an appeal.
    Current Sec.  405.1032(a) states that the issues before the ALJ 
include all of the issues brought out in the initial determination, 
redetermination, or reconsideration that were not decided entirely in a 
party's favor. However, when a request for hearing involves a 
reconsideration of multiple claims and the appellant does not identify 
one or more of the claims that were not decided entirely in the party's 
favor at initial determination, redetermination, or reconsideration, it 
is unclear whether the ALJ should review all of the claims that were 
not decided entirely in the party's favor at initial determination, 
redetermination, or reconsideration, or just those claims specified by 
the appellant in the request for hearing. An appellant is required to 
identify the dates of service for the claims that it wishes to appeal 
in its request for hearing under Sec.  405.1014, and some appellants 
have indicated that they do not specify a denied claim in a request for 
hearing when they agree that the record does not support coverage of 
the claim. To address the ambiguity, and in the interest of efficiency 
and consistency with Sec.  405.1014, we are proposing in Sec.  
405.1032(a) that the issues before the ALJ or attorney adjudicator 
include all the issues for the claims or appealed matter (for example, 
for appeals that do not involve a claim for items or services furnished 
to a beneficiary, such as Medicare Secondary Payer appeals and 
terminations of coverage) specified in the request for hearing that 
were brought out in the initial determination, redetermination, or 
reconsideration that were not decided entirely in a party's favor. We 
are proposing at Sec.  423.2032(a) to adopt a corresponding revision 
for issues in part 423, subpart U proceedings, except the term claims 
is not used because part 423, subpart U appeals do not involve claims.
    Current Sec.  405.1032(a) also notes that if evidence presented 
before the hearing causes the ALJ to question a favorable portion of 
the determination, the ALJ notifies the parties before the hearing and 
may consider it an issue at the hearing. As explained in the 2005 
Interim Final Rule (70 FR 11462), this provision relates to the 
favorable portion of an appealed claim, and that the favorable issue is 
a new issue that must meet the requirements of current paragraph (b). 
However, in practice, this provision has been read to allow 
consideration of separate claims that were decided in a party's favor 
at lower appeal levels in multiple-claim appeals, and at times read 
independently from paragraph (b). To address this confusion, we are 
proposing to move this language in Sec.  405.1032(a) to proposed Sec.  
405.1032(b), with the revisions discussed below. We are proposing at 
Sec.  423.2032(a) and (b) to adopt corresponding revisions for new 
issues in part 423, subpart U proceedings.
    Current Sec.  405.1032(b) allows new issues to be considered at the 
hearing if: (1) the ALJ notifies the parties about the new issue before 
the start of the hearing; (2) the resolution of the new issue could 
have a material impact on the claim or claims that are the subject of 
the request for hearing; and (3) its resolution is permissible under 
the rules governing reopening of determinations and decisions. We are 
proposing at Sec.  405.1032(b) to incorporate these provisions, with 
the revisions discussed below, as well as the language regarding 
consideration of favorable issues moved from current Sec.  405.1032(a), 
in a revised structure.
    We are proposing in Sec.  405.1032(b)(1) to address when a new 
issue may be considered. Specifically, we are proposing that the ALJ 
may only consider the new issue, including a favorable portion of a 
determination on a claim or appealed matter specified in the request 
for hearing, if its resolution could have a material impact on the 
claim or appealed matter, and (1) there is new or material evidence 
that was not available or known at the time of the determination and 
which may result in a different conclusion, or (2) the evidence that 
was considered in making the determination clearly shows on its face 
that an obvious error was made at the time of the determination. This 
would consolidate the current provisions to better convey when a new 
issue may be considered, clarify that a new issue relates to a claim or 
appealed matter specified in the request for hearing, and provide the 
applicable standards from the reopening rules referenced in current 
Sec.  405.1032(b)(1)(ii). We are proposing in Sec.  405.1032(b)(1) to 
continue to provide that the new issue may be raised by the ALJ or any 
party and may include issues resulting from the participation of CMS, 
but correct the language so that it also references participation of 
CMS

[[Page 43833]]

contractors. We are proposing at Sec.  423.2032(b)(1) to adopt 
corresponding revisions for when new issues may be considered in part 
423, subpart U proceedings.
    We are proposing at Sec.  405.1032(b)(2) to continue to provide 
that notice of the new issue must be provided before the start of the 
hearing, but would limit the notice to the parties who were or will be 
sent the notice of hearing, rather than the current standard to notice 
``all of the parties.'' Because notice of the new issue may be made in 
the notice of hearing or after the notice of hearing, and parties 
generally have 10 calendar days after receipt of the notice of hearing 
to submit evidence, we are proposing at Sec.  405.1032(b)(3) to also 
provide that if notice of the new issue is sent after the notice of 
hearing, the parties would have at least 10 calendar days after 
receiving the notice of the new issue to submit evidence regarding the 
issue. As provided in proposed Sec.  405.1028(a)(2)(ii), the ALJ would 
then determine whether the new evidence is material to the new issue 
identified by the ALJ. If an adjudication time frame applies to the 
appeal, the adjudication period would not be affected by the submission 
of evidence. Further, we are proposing at Sec.  405.1032(b)(3) that if 
the hearing is conducted before the time to submit evidence regarding 
the issue expires, the record would remain open until the opportunity 
to submit evidence expires to provide the parties sufficient time to 
submit evidence regarding the issue. We are proposing at Sec.  
423.2032(b)(2) and (b)(3) to adopt corresponding provisions for 
providing notice of new issues to enrollees and an opportunity to 
submit evidence, and to add that an enrollee will have 2 calendar days 
after receiving notice of the new issue in an expedited appeal to 
submit evidence, which corresponds to the length of time permitted 
under proposed Sec.  423.2018(c) to submit evidence after receiving a 
notice of expedited hearing.
    Current Sec.  405.1032(c) states that an ALJ cannot add any claim, 
including one that is related to an issue that is appropriately before 
an ALJ, to a pending appeal unless the claim has been adjudicated at 
the lower appeal levels and all parties are notified of the new issues 
before the start of the hearing. However, in practice, we are unaware 
that this provision is used, and to the extent it may be used, we 
believe it would be disruptive to the adjudication process, result in 
filing requirements not being observed, and risk adjudication of the 
same claim by multiple adjudicators. Therefore, we are proposing to 
maintain the topic of adding claims to a pending appeal, but replace 
the language of current Sec.  405.1032(c), as explained below.
    A reconsideration may be appealed for an ALJ hearing regardless of 
the number of claims involved in the reconsideration. However, we 
recognize that a party may not specify all of the claims from a 
reconsideration that he or she wishes to appeal in the party's request 
for hearing. We are proposing in Sec.  405.1032(c)(1) to address this 
circumstance by providing that claims that were not specified in a 
request for hearing may only be added to a pending appeal if the claims 
were adjudicated in the same reconsideration that is appealed in the 
request for hearing, and the period to request an ALJ hearing for that 
reconsideration has not expired, or an ALJ or attorney adjudicator 
extends the time to request an ALJ hearing on those claims to be added 
in accordance with proposed Sec.  405.1014(e). We believe that this 
would result in less disruption to the adjudication process, greater 
adherence to filing requirements, and reduce the risk of adjudication 
of the same claim by multiple adjudicators. To help ensure that the 
copy requirement of proposed Sec.  405.1014(d) is observed, we are 
proposing at Sec.  405.1032(c)(2) to require that before a claim may be 
added to a pending appeal, the appellant must submit evidence that 
demonstrates that the information that constitutes a complete request 
for hearing in accordance with Sec.  405.1014(b) and other materials 
related to the claim that the appellant seeks to add to the pending 
appeal were sent to the other parties to the claim in accordance with 
Sec.  405.1014(d). We are proposing at Sec.  423.2032(c) to adopt a 
provision corresponding to proposed Sec.  405.1032(c)(1), but we are 
not proposing to adopt a provision corresponding to Sec.  
405.1032(c)(2) because there is no Sec.  423.2014 requirement for an 
enrollee to send a copy of his or her request to others.
    Current Sec.  405.1032 does not address issues related to an appeal 
that involves a disagreement with how a statistical sample and/or 
extrapolation was conducted. When an appeal involves a statistical 
sample and an extrapolation and the appellant wishes to challenge how 
the statistical sample and/or extrapolation was conducted, as discussed 
previously, we are proposing at Sec.  405.1014(a)(3)(iii) to require 
the appellant to assert the reasons the appellant disagrees with how 
the statistical sampling and/or extrapolation was conducted in the 
request for hearing. We are proposing at Sec.  405.1032(d)(1) to 
reinforce this requirement by excluding issues related to how the 
statistical sample and/or extrapolation were conducted if the appellant 
does not comply with Sec.  405.1014(a)(3)(iii). In addition to 
reinforcing the proposed requirement at Sec.  405.1014(a)(3)(iii), we 
believe that excluding the issue is appropriate because an appellant 
should reasonably be aware of whether it disagrees with how the 
statistical sampling and/or extrapolation was conducted at the time it 
files a request for hearing, and raising the issue later in the 
adjudication process or at the hearing can cause significant delays in 
adjudicating an appeal because the ALJ may need to conduct additional 
fact finding, find it necessary to request participation of CMS or one 
of its contractors, and/or call expert witnesses to help address the 
issue.
    Related to the issues that an ALJ must consider, the 2005 Interim 
Final Rule (70 FR 11466) explained that current Sec.  405.1064 was 
added to set forth a general rule regarding ALJ decisions that are 
based on statistical samples because a decision that is based on only a 
portion of a statistical sample does not accurately reflect the entire 
record. As discussed in the 2009 Final Rule (74 FR 65328), current 
Sec.  405.1064 explains that when an appeal from the QIC involves an 
overpayment, and the QIC used a statistical sample in reaching its 
reconsideration, the ALJ must base his or her decision on a review of 
all claims in the sample. However, while a review of the claims 
selected for the sample is necessary to review issues related to a 
contested sample and extrapolation, for example to determine whether 
the sample claims were appropriately selected for a representative 
sample of the universe, current Sec.  405.1064 has been read more 
broadly to also require adjudication of each sample claim, regardless 
of whether the sample claim was adjudicated favorably at lower appeal 
levels. We do not believe adjudicating sample claims that were decided 
favorably at lower levels of appeal, or sample claims that are not 
appealed by a party, is necessary to adjudicate broader issues with how 
sampling and extrapolation was conducted, and the broader reading of 
current Sec.  405.1064 results in unnecessary adjudications of claims 
that were not appealed.
    To clarify what is at issue and what must be considered in appeals 
involving statistical sampling and extrapolations, we are proposing to 
remove current Sec.  405.1064, and address the matter in Sec.  
405.1032(d)(2). We are proposing in Sec.  405.1032(d)(2) that if a 
party asserts a disagreement with how the statistical sampling 
methodology and

[[Page 43834]]

extrapolation were conducted in the request for hearing, in accordance 
with proposed Sec.  405.1014(a)(3)(iii), Sec.  405.1032(a) through (c) 
would apply to the adjudication of the sample claims. The result of 
applying proposed Sec.  405.1032(a) and (b) would be that only the 
sample units that were specified in the request for hearing are 
individually adjudicated, subject to a new issue being identified for 
an appealed claim. However, proposed Sec.  405.1032(c) would permit 
adding sample claims to a pending appeal if they were adjudicated in 
the appealed reconsideration and the time to request a hearing on the 
reconsideration has not expired, or the ALJ or attorney adjudicator 
extends the time to request an ALJ hearing on those claims in 
accordance with Sec.  405.1014(e). To incorporate the principle 
embodied in current Sec.  405.1064, we are proposing in Sec.  
405.1032(d)(2) that in deciding issues related to how a statistical 
sample and/or extrapolation was conducted, the ALJ or attorney 
adjudicator would base his or her decision on a review of the entire 
sample to the extent appropriate to decide the issue. We believe this 
more clearly conveys the intent of the rule and recognizes that an 
individual adjudication of each claim in the sample is not always 
necessary to decide an issue related to how a statistical sample and/or 
extrapolation was conducted, such as whether there is documentation so 
that the sampling frame can be re-created, as required by the Medicare 
Program Integrity Manual (Internet-Only Manual 100-08) (see chapter 8, 
Sec.  8.4.4.4.1). We are not proposing any corresponding changes in 
Sec.  423.2030 because statistical sampling and extrapolation are not 
currently used for matters that are subject to part 423, subpart U 
proceedings.
    We are inviting public comments on these proposals. If you choose 
to comment on the proposals in this section, please include the caption 
``Issues before an ALJ or attorney adjudicator'' at the beginning of 
your comment.
p. Requesting Information From the QIC or IRE, and Remanding an Appeal 
(Sec. Sec.  405.1034, 405.1056, 405.1058, 423.2034, 423.2056, and 
423.2058)
    Current Sec. Sec.  405.1034 and 423.2034 describe when an ALJ may 
request information from, or remand a case to a QIC or IRE. When the 
ALJ believes that the written record is missing information that is 
essential to resolving the issues on appeal and that information can be 
provided only by CMS or its contractors, including an IRE, or the Part 
D plan sponsor, current Sec. Sec.  405.1034(a) and 423.2034(a) allow an 
ALJ to remand the case to the QIC or IRE that issued the 
reconsideration, or retain jurisdiction of the case and request that 
the entity forward the missing information to the appropriate hearing 
office. The 2005 Interim Final Rule (70 FR 11465) explained that in the 
rare instance in which the file lacks necessary technical information 
that can only be provided by CMS or its contractors, it was believed 
that the most effective way of completing the record is to return the 
case, via remand, to the contractor; however, the ALJ also had the 
option of asking the entity to forward the missing information to the 
ALJ hearing office. In practice, stakeholders have expressed 
frustration and concern with the remand provisions because in 
accordance with the definition of a remand in Sec.  405.902, a remand 
vacates the lower level appeal decision and therefore may require a QIC 
or IRE to issue a new reconsideration, for which the appellant must 
submit a new request for hearing, which causes additional delay in 
reaching finality on the disputed claims. In addition, current 
Sec. Sec.  405.1034 and 423.2034 do not address providing notice of a 
remand or the effects of a remand.
    To address stakeholders' concerns with the current remand 
provisions, and areas not addressed in current Sec. Sec.  405.1034 and 
423.2034, we are proposing to revise the sections to cover obtaining 
information that can be provided only by CMS or its contractors, or the 
Part D plan sponsor, and establishing new Sec. Sec.  405.1056 and 
405.1058 to address remands to a QIC, and new Sec. Sec.  423.2056 and 
423.2058 to address remands to an IRE.
    We are proposing in Sec.  405.1034(a) to maintain the current 
standards for requesting information that is missing from the written 
record when that information can be provided only by CMS or its 
contractors, but limit the action to a request for information directed 
to the QIC that conducted the reconsideration or its successor (if a 
QIC contract has been awarded to a new contractor). In addition, we are 
revising Sec.  405.1034(a) to include attorney adjudicators because 
attorney adjudicators would be authorized to adjudicate appeals, as 
proposed in section II.B. Also, while we are proposing to retain the 
definition of ``can be provided only by CMS or its contractors'' in 
Sec.  405.1034(a)(2), we are proposing at Sec.  405.1034(a)(1) to 
specify that official copies of redeterminations and reconsiderations 
that were conducted on the appealed claims can be provided only by CMS 
or its contractors. The redetermination and reconsideration are 
important documents that establish the issues on appeal, and while the 
parties often have copies of them, we believe the record should include 
official copies from the contractors. In addition, we are proposing at 
Sec.  405.1034(b) to specify that the ALJ or attorney adjudicator would 
retain jurisdiction of the case, and the case would remain pending at 
OMHA. We are proposing at Sec.  423.2034(a) and (b) to adopt 
corresponding provisions for when information may be requested from an 
IRE and that jurisdiction is retained at OMHA in part 423, subpart U 
proceedings.
    We are proposing in Sec.  405.1034(c) that the QIC would have 15 
calendar days after receiving the request for information to furnish 
the information or otherwise respond to the request for information, 
either directly or through CMS or another contractor. This proposal 
would provide the ALJ or attorney adjudicator, the QIC, and the parties 
with a benchmark for obtaining the information and determining when 
adjudication of the case can resume. We are proposing in Sec.  
405.1034(d) that, if an adjudication period applies to the appeal in 
accordance with Sec.  405.1016, the adjudication period would be 
extended by the period between the date of the request for information 
and the date the QIC responds to the request or 20 calendar days after 
the date of the request, whichever is less. We recognize that other 
provisions that extend an applicable adjudication period generally 
involve an appellant's action or omission that delays adjudicating an 
appeal within an applicable time frame, but we believe that an 
extension is also warranted to fully develop the record when the 
written record is missing information that is essential to resolving 
the issues on appeal, and that 20 calendar days (5 calendar days for 
the request to be received by the QIC and 15 calendar days for the QIC 
to respond) is a relatively modest delay in order to obtain missing 
information that is essential to resolving the appeal. We are proposing 
at Sec.  423.2034(c) and (d) to adopt corresponding provisions for the 
IRE to furnish the information or otherwise respond to the request for 
information, either directly or through CMS or the Part D plan sponsor, 
and the effect on any applicable adjudication time frame in part 423, 
subpart U proceedings. In addition, we are proposing at Sec.  
423.2034(c) and (d) to provide for an accelerated response time frame 
for expedited appeals because of the urgency involved. For expedited 
appeals, we are proposing that the IRE

[[Page 43835]]

would have 2 calendar days after receiving a request for information to 
furnish the information or otherwise respond to the request, and the 
extension to the adjudication time frame would be up to 3 calendar 
days, to allow for time to transmit the request to the IRE and for the 
IRE to respond.
    We are proposing to add new Sec.  405.1056 to describe when a 
request for hearing or request for review of a QIC dismissal may be 
remanded, and new Sec.  405.1058 to describe the effect of a remand. We 
are proposing in Sec.  405.1056(a)(1) to permit a remand if an ALJ or 
attorney adjudicator requests an official copy of a missing 
redetermination or reconsideration for an appealed claim in accordance 
with proposed Sec.  405.1034, and the QIC or another contractor does 
not furnish the copy within the time frame specified in Sec.  405.1034. 
We also are proposing in Sec.  405.1056(a)(2) to permit a remand when 
the QIC does not furnish a case file for an appealed reconsideration. 
The remand under both provisions would direct the QIC or other 
contractor (such as a Medicare Administrative Contractor that made the 
redetermination) to reconstruct the record or initiate a new appeal 
adjudication. We expect this type of remand to be very rare, but we 
believe it is necessary to help ensure a complete administrative record 
of the administrative adjudication of a claim. To address the 
possibility that the QIC or another contractor is able to reconstruct 
the record for a remanded case, we are proposing in Sec.  
405.1056(a)(3) to provide that in the situation where a record is 
reconstructed by the QIC, the reconstructed record would be returned to 
OMHA, the case would no longer be remanded and the reconsideration 
would no longer be vacated, and if an adjudication period applies to 
the case, the period would be extended by the time between the date of 
the remand and the date the case is returned to OMHA because OMHA was 
unable to adjudicate the appeal between when it was remanded and when 
it was returned to OMHA. This would help ensure that appellants are not 
required to re-start the ALJ hearing or dismissal review process in the 
event that the QIC or another contractor is able to reconstruct the 
record. We are proposing at Sec.  423.2056(a) to adopt corresponding 
provisions for remanding cases in which there is a missing appeal 
determination or the IRE is unable to furnish the case file in part 
423, subpart U proceedings.
    On occasion, an ALJ finds that a QIC issued a reconsideration that 
addresses coverage or payment issues related to the appealed claim when 
a redetermination was required and no redetermination was conducted, or 
the contractor dismissed the request for redetermination and the 
appellant appealed the contractor's dismissal. In either circumstance, 
the reconsideration was issued in error because the appellant did not 
have a right to the reconsideration in accordance with current Sec.  
405.960, which only provides a right to a reconsideration when a 
redetermination is made by a contractor. We do not believe that an 
administrative error made by the QIC conveys rights that are not 
afforded under the rules. We are proposing in Sec.  405.1056(b) to 
address these circumstances so that, if an ALJ or attorney adjudicator 
finds that the QIC issued a reconsideration that addressed coverage or 
payment issues related to the appealed claim and no redetermination of 
the claim was made (if a redetermination was required) or the request 
for redetermination was dismissed (and not vacated), the 
reconsideration would be remanded to the QIC that issued the 
reconsideration, or its successor, to re-adjudicate the request for 
reconsideration. We again expect this type of remand to be rare, but 
believe it is necessary to correct administrative errors in the 
adjudication process. We are proposing at Sec.  423.2056(b) to adopt a 
corresponding provision for when an IRE issues a reconsideration that 
addresses drug coverage when no redetermination was conducted or a 
request for redetermination was dismissed and is appealed to OMHA under 
part 423, subpart U.
    OMHA ALJs sometimes receive requests for remands from CMS or a 
party because the matter can be resolved by a CMS contractor if 
jurisdiction of the claim is returned to the QIC. Current Sec.  
405.1034 does not address this type of request. We are proposing at 
Sec.  405.1056(c)(1) to provide a mechanism for these remands. 
Specifically, we are proposing that at any time prior to an ALJ or 
attorney adjudicator issuing a decision or dismissal, the appellant and 
CMS or one of its contractors, may jointly request a remand of the 
appeal to the entity that conducted the reconsideration. We are 
proposing that the request include the reasons why the appeal should be 
remanded and indicate whether remanding the case would likely resolve 
the matter in dispute. Proposed Sec.  405.1056(c)(2) would allow the 
ALJ or attorney adjudicator to determine whether to grant the request 
and issue the remand, based on his or her determination of whether 
remanding the case would likely resolve the matter in dispute. We 
believe this added flexibility would allow appellants and CMS and its 
contractors to expedite resolution of a disputed claim when there is 
agreement to do so. We are proposing at Sec.  423.2056(c) to adopt 
corresponding provisions for requested remands in part 423, subpart U 
proceedings.
    Current Sec.  405.1034(b) provides that if, consistent with current 
Sec.  405.1004(b), the ALJ determines that a QIC's dismissal of a 
request for reconsideration was in error, the case will be remanded to 
the QIC. We are proposing at Sec.  405.1056(d) to incorporate this 
provision and proposed Sec.  423.2056(d) would adopt a corresponding 
provision to incorporate current Sec.  423.2034(b)(1) for remanding 
cases in which an IRE's dismissal of a request for reconsideration was 
in error, in part 423, subpart U proceedings. In addition, we are 
proposing at Sec.  423.2056(e) to incorporate current Sec.  
423.2034(b)(2), which provides that if an enrollee wants evidence of a 
change in his or her condition to be considered in the appeal, the 
appeal would be remanded to the IRE for consideration of the evidence 
on the change in condition.
    Current Sec.  405.1034(c) provides that the ALJ remands an appeal 
to the QIC that made the reconsideration if the appellant is entitled 
to relief pursuant to 42 CFR 426.460(b)(1), 426.488(b), or 
426.560(b)(1), and provides that unless the appellant is entitled to 
such relief, the ALJ applies the LCD or NCD in place on the date the 
item or service was provided. We are proposing to incorporate these 
provisions at Sec.  405.1056(e). We did not propose any corresponding 
provision for Sec.  423.2056 because there is not a similar current 
provision for part 423, subpart U proceedings.
    As noted above, current Sec.  405.1034 does not address providing a 
notice of remand. We are proposing at Sec.  405.1056(f) to provide that 
OMHA mails or otherwise transmits a written notice of the remand of the 
request for hearing or request for review to all of the parties who 
were sent a copy of the request at their last known address, and CMS or 
a contractor that elected to be a participant to the proceedings or a 
party to the hearing. The notice would state that, as discussed below, 
there is a right to request that the Chief ALJ or a designee review the 
remand. We believe this would help ensure that the parties and CMS and 
its contractors receive notice that the remand order has been issued. 
We are proposing at Sec.  423.2056(f) to adopt a corresponding 
provision for a notice of remand in part

[[Page 43836]]

423, subpart U proceedings, except that only the enrollee receives 
notice because only the enrollee is a party, and CMS, the IRE, and the 
Part D plan sponsor only receive notice if they requested to 
participate and the request was granted.
    Stakeholders have recounted instances in which they believe a 
remand was not authorized by the regulations, but were unable to take 
any action to correct the perceived error because a remand is not an 
appealable action and current Sec.  405.1034 does not provide a review 
mechanism. We do not believe that remands should be made appealable 
actions, but recognize that stakeholders need a mechanism to address 
remands that they believe are not authorized by the regulation. We are 
proposing in Sec.  405.1056(g) to provide a mechanism to request a 
review of a remand by allowing a party or CMS, or one of its 
contractors, to file a request to review a remand with the Chief ALJ or 
a designee within 30 calendar days of receiving a notice of remand. If 
the Chief ALJ or designee determines that the remand is not authorized 
by Sec.  405.1056, the remand order would be vacated. We are also 
proposing that the determination on a request to review a remand order 
is binding and not subject to further review so adjudication of the 
appeal can proceed. We are proposing at Sec.  423.2056(g) to adopt a 
corresponding provision for reviewing a remand in part 423, subpart U 
proceedings.
    Current Sec.  405.1034 does not discuss the effect of a remand. We 
are proposing at Sec.  405.1058, similar to current Sec. Sec.  405.1048 
and 405.1054 which describe the effects of a decision and dismissal, 
respectively, that a remand of a request for hearing or request for 
review is binding unless it is vacated by the Chief ALJ or a designee 
in accordance with proposed Sec.  405.1056(g). We believe the provision 
would add clarity for the parties and other stakeholders on the effect 
of a remand order. We are proposing at Sec.  423.2058 to adopt a 
corresponding provision for the effect of a remand in part 423, subpart 
U proceedings.
    We are inviting public comments on these proposals. If you choose 
to comment on the proposals in this section, please include the caption 
``Requesting information from the QIC or IRE, and remanding an appeal'' 
at the beginning of your comment.
q. Description of the ALJ Hearing Process and Discovery (Sec. Sec.  
405.1036, 405.1037, and 423.2036)
    Current Sec. Sec.  405.1036 and 423.2036 describe the ALJ hearing 
process, including the right to appear and present evidence, waiving 
the right to appear at the hearing, presenting written statements and 
oral arguments, waiver of the adjudication period, what evidence is 
admissible at the hearing, subpoenas, and witnesses at a hearing. 
Current Sec.  405.1037 describes the discovery process in part 405, 
subpart I proceedings, which is permitted when CMS or a contractor 
elects to be a party to the ALJ hearing; there is no corresponding 
provision for part 423, subpart U proceedings because CMS, the IRE, and 
the Part D plan sponsor may not be made parties to the hearing.
    Current Sec.  405.1036(b)(1) states that a party may ``send the 
ALJ'' a written statement indicating that he or she does not wish to 
appear at the hearing. We are proposing at Sec.  405.1036(b)(1) to 
revise this provision to state that a party may ``submit to OMHA'' a 
written statement indicating that he or she does not wish to appear at 
the hearing. While the written statement could still be sent to an ALJ 
who is assigned to a request for hearing, we are proposing that the 
statement could be submitted to OMHA (for example, the statement could 
be submitted with the request for hearing), or to the ALJ or attorney 
adjudicator, as proposed in section II.B above, after the request is 
assigned, to provide more flexibility and to accommodate situations 
where an ALJ or attorney adjudicator has not been assigned a request 
for hearing. We are proposing at Sec.  423.2036(b)(1) to adopt a 
corresponding revision for submitting a waiver of the right to appear 
in part 423, subpart U proceedings. In addition, we are proposing at 
Sec.  423.2036(b)(1)(ii) to revise the current requirement for the 
``ALJ hearing office'' to document oral requests to require ``OMHA'' to 
document oral requests, to help ensure that applicability of the 
requirement is clear regardless of whether the oral request is received 
by an adjudicator in an OMHA field office after the appeal is assigned 
to an ALJ or attorney adjudicator, or the oral request is received in 
the OMHA central office before the appeal is assigned to an ALJ or 
attorney adjudicator.
    As discussed in section III.A.3.h above, we are proposing to move 
the provision for waiving the adjudication period from current Sec.  
405.1036(d) to proposed Sec.  405.1016(d) because proposed Sec.  
405.1016 addresses adjudication time frames and we believe the section 
is a better place for discussing adjudication time frame waivers. To 
accommodate moving current Sec.  405.1036(d) to proposed Sec.  
405.1016(d), we are proposing to re-designate current Sec.  
405.1036(g), which describes witnesses at the hearing, as proposed 
Sec.  405.1036(d) because it more logically follows the discussion of 
presenting witnesses and oral arguments in current Sec.  405.1036(c). 
For the same reasons, we are proposing to move the provisions at Sec.  
423.2036(d) to proposed Sec.  423.2016(c), and proposing at Sec.  
423.2036(d) to re-designate current Sec.  423.2036(g) as proposed Sec.  
423.2036(d) to describe witnesses at a hearing in part 423, subpart U 
proceedings.
    Current Sec.  405.1036(f) discusses subpoenas. Current Sec.  
405.1036(f)(5)(i) states that an ALJ ruling on a subpoena request is 
not subject to immediate review by the Council and may be reviewed 
solely during the course of the Council's review specified in Sec.  
405.1102 (for requests for Council review when an ALJ issues a decision 
or dismissal), Sec.  405.1104 (for requests for escalation to the 
Council), or Sec.  405.1110 (for referrals for own motion review by the 
Council). As discussed in section III.A.3.h.ii above, we are proposing 
to remove section Sec.  405.1104 and relocate provisions dealing with 
escalation to the Council to Sec.  405.1016. Because the process for 
requesting escalation to the Council is now described in proposed Sec.  
405.1016(e) and (f), we are proposing at Sec.  405.1036(f)(5)(i) to 
replace the reference to Sec.  405.1104 with a reference to Sec.  
405.1016(e) and (f). Current Sec.  405.1036(f)(5)(ii) discusses CMS 
objections to a ``discovery ruling'' in the context of a paragraph on 
reviewability of subpoena rulings and current Sec.  405.1037(e)(2)(i) 
separately addresses CMS objections to a discovery ruling. We are 
proposing to revise Sec.  405.1036(f)(5)(ii) to replace the current 
reference to a ``discovery ruling'' with ``subpoena ruling'' so it is 
consistent with the topic covered by Sec.  405.1036(f). No 
corresponding revisions are necessary in Sec.  423.2036(f) because 
there is no reference to a ``discovery ruling.''
    Current Sec.  405.1037(a)(1) provides that discovery is permissible 
only when CMS or its contractors elects to participate in an ALJ 
hearing as a party. While the intent is generally clear, the use of 
``participate'' is potentially confusing given CMS or one of its 
contractors can elect to be a participant in the proceedings, including 
the hearing, in accordance with current and proposed Sec.  405.1010, or 
elect to be a party to the hearing in accordance with current and 
proposed Sec.  405.1012. We are proposing to revise Sec.  
405.1037(a)(1) to state that discovery is permissible only when CMS or 
its contractor elects to be a party to an ALJ hearing, in accordance 
with proposed Sec.  405.1012. As noted above, there are no provisions 
for discovery in part 423, subpart U proceedings because CMS, the IRE, 
or

[[Page 43837]]

the Part D plan sponsor are not permitted to be a party to the hearing.
    Current Sec.  405.1037(e)(1) states that an ALJ discovery ruling or 
disclosure ruling is not subject to immediate review by the Council and 
may be reviewed solely during the course of the Council's review 
specified in Sec.  405.1100 (for Council review in general), Sec.  
405.1102 (for requests for Council review when an ALJ issues a decision 
or dismissal), Sec.  405.1104 (for requests for escalation to the 
Council), or Sec.  405.1110 (for referrals for own motion review by the 
Council). For the reasons discussed above with regard to similar 
proposed changes in Sec.  405.1036, we are proposing at Sec.  
405.1037(e)(1) to replace the reference to Sec.  405.1104 with a 
reference to Sec.  405.1016(e) and (f).
    Current Sec.  405.1037(f) describes the effect of discovery on an 
adjudication time frame, and provides that the time frame is tolled 
until the discovery dispute is resolved. However, it does not clearly 
state when the effect on an adjudication time frame begins, and 
``discovery dispute'' is not used elsewhere in the section. In 
addition, current Sec.  405.1037(f) does not contemplate that an 
adjudication time frame may not apply (for example, when the 
adjudication time frame is waived in accordance with proposed Sec.  
405.1016(d)). Therefore, we are proposing to revise Sec.  405.1037(f) 
to state that if an adjudication period applies to the appeal in 
accordance with Sec.  405.1016, and a party requests discovery from 
another party to the hearing, the adjudication period is extended for 
the duration of discovery, from the date a discovery request is granted 
until the date specified for ending discovery. We believe this revision 
would provide a clearer standard for how an adjudication period is 
affected by discovery proceedings.
    We are inviting public comments on these proposals. If you choose 
to comment on the proposals in this section, please include the caption 
``Description of the ALJ hearing process and discovery'' at the 
beginning of your comment.
r. Deciding a Case Without a Hearing Before an ALJ (Sec. Sec.  405.1038 
and 423.2038)
    Current Sec.  405.1038(a) provides authority to issue a ``wholly 
favorable'' decision without a hearing before an ALJ and without giving 
the parties prior notice when the evidence in the hearing record 
supports a finding in favor of the appellant(s) on every issue. We are 
proposing in Sec.  405.1038 that if the evidence in the administrative 
record supports a finding in favor of the appellant(s) on every issue 
and no other party to the appeal is liable for claims at issue, an ALJ 
or attorney adjudicator, as proposed in section II.B above, may issue a 
decision without giving the parties prior notice and without an ALJ 
conducting a hearing, unless CMS or a contractor has elected to be a 
party to the hearing in accordance with Sec.  405.1012. Proposed Sec.  
405.1038(a) would replace ``wholly favorable'' with ``fully favorable'' 
in the subsection heading to align with language in Sec.  405.1000(g), 
which addresses a fully favorable decision being made on the record, 
and the nomenclature used in OMHA's day to day operations. Proposed 
Sec.  405.1038(a) would also replace ``hearing record'' with 
``administrative record'' for consistency with other references to the 
record, and replace ``hearing decision'' with ``decision,'' for 
consistency with other references to a decision. We are proposing at 
Sec.  423.2038(a) to adopt corresponding revisions to align with 
language in Sec.  423.2000(g) and to make references to the record and 
decisions consistent in part 423, subpart U proceedings.
    Proposed Sec.  405.1038(a) would also add two new limitations on 
issuing a decision without a hearing before an ALJ when the evidence in 
the administrative record supports a finding in favor of the 
appellant(s) on every issue. First, a decision could not be issued 
pursuant to proposed Sec.  405.1038(a) if another party to the appeal 
is liable for the claims at issue. Second, a decision could not be 
issued pursuant to proposed Sec.  405.1038(a) if CMS or a contractor 
elected to be a party to the hearing in accordance with Sec.  405.1012. 
We recognize that this may limit decisions that may be issued pursuant 
to Sec.  405.1038(a); however, we believe only a small number of 
appeals would be affected, and the new limitations would mitigate the 
impact of such a decision on the other parties to the appeal and the 
likelihood of an appeal to, and remand from, the Council. No 
corresponding changes are proposed in Sec.  423.2038(a) because only 
the enrollee is a party in part 423, subpart U proceedings.
    Current Sec.  405.1038(b)(1) permits the ALJ to decide a case on 
the record and not conduct a hearing if: (1) All the parties indicate 
in writing that they do not wish to appear before the ALJ at a hearing, 
including a hearing conducted by telephone or video-teleconferencing, 
if available; or (2) an appellant lives outside of the United States 
and does not inform the ALJ that he or she wants to appear, and there 
are no other parties who wish to appear. We are proposing to retain 
this structure in proposed Sec.  405.1038(b) but are proposing some 
changes. Current Sec.  405.1038(b)(1)(i) requires all parties to 
indicate in writing that they do not wish to appear before the ALJ at a 
hearing, and as indicated above, current Sec.  405.1038(b)(1)(ii) is 
contingent on no other parties wishing to appeal. However, the 
requirement to obtain a writing from all parties or determine the 
wishes of the non-appellant parties has limited the utility of the 
provisions. While all parties have a right to appear at the hearing, a 
notice of hearing is not sent to parties who did not participate in the 
reconsideration and were not found liable for the items or services at 
issue after the initial determination, in accordance with current Sec.  
405.1020(c). We are proposing at Sec.  405.1038(b)(1)(i) and (b)(1)(ii) 
to modify the requirements so writings only need to be obtained from, 
or wishes assessed from, parties who would be sent a notice of hearing, 
if a hearing were to be conducted. Using the notice of hearing standard 
protects the interests of potentially liable parties, while making the 
provisions a more effective option for the efficient adjudication of 
appeals. In addition, proposed Sec.  405.1038(b)(1) would reinforce 
that only an ALJ conducts a hearing by indicating an ALJ or attorney 
adjudicator may decide a case on the record without an ALJ conducting a 
hearing. Proposed Sec.  405.1038(b)(1)(ii) also would indicate that an 
appellant who lives outside of the United States would inform ``OMHA'' 
rather than ``the ALJ'' that he or she wants to appear at a hearing 
before an ALJ, so an appellant could make that indication before an 
appeal is assigned to an ALJ or attorney adjudicator. We are proposing 
at Sec.  423.2038(b)(1) and (b)(1)(ii) to adopt corresponding revisions 
to reinforce that only an ALJ conducts a hearing and an enrollee who 
lives outside of the United States would inform OMHA that he or she 
wishes to appear at a hearing before an ALJ, but the other changes in 
proposed Sec.  405.1038(b) are not made to Sec.  423.2038(b) because 
only the enrollee is a party in part 423, subpart U proceedings. We are 
also proposing in Sec.  405.1038(b)(1)(i) to replace 
``videoteleconferencing,'' and in Sec.  423.2038(b)(1)(i) to replace 
``video teleconferencing,'' with ``video-teleconferencing,'' for 
consistency with terminology used in Sec. Sec.  405.1000, 405.1036, 
423.2000, 423.2020, and 423.2036.
    On occasion, CMS or one of its contractors indicates that it 
believes an item or service should be covered or payment made on an 
appealed claim,

[[Page 43838]]

either before or at a hearing. However, there are no current provisions 
that address this circumstance and it is one that is ideal for a 
summary decision in favor of the parties based on the statement by CMS 
or its contractor, in lieu of a full decision that includes findings of 
fact, conclusions of law, and other decision requirements. We are 
proposing to add Sec.  405.1038(c) to provide a new authority for a 
stipulated decision, when CMS or one of its contractors submits a 
written statement or makes an oral statement at a hearing indicating 
the item or service should be covered or paid. In this situation, an 
ALJ or attorney adjudicator may issue a stipulated decision finding in 
favor of the appellant or other liable parties on the basis of the 
statement, and without making findings of fact, conclusions of law, or 
further explaining the reasons for the decision. We are proposing at 
Sec.  423.2038(c) to adopt a corresponding authority for stipulated 
decisions in part 423, subpart U proceedings.
    We are inviting public comments on these proposals. If you choose 
to comment on the proposals in this section, please include the caption 
``Deciding a case without a hearing before an ALJ'' at the beginning of 
your comment.
s. Prehearing and Posthearing Conferences (Sec. Sec.  405.1040 and 
423.2040)
    Current Sec.  405.1040 discusses prehearing and posthearing 
conferences and permits the ALJ to hold these conferences to facilitate 
the hearing or hearing decision. Current Sec.  405.1040(b) requires an 
ALJ to inform ``the parties'' of the time, place, and purpose of the 
prehearing or posthearing conference, unless a party indicates in 
writing that it does not wish to receive a written notice of the 
conference. In accordance with current Sec.  405.1020(c), the notice of 
hearing is not sent to a party who did not participate in the 
reconsideration and was not found liable for the services at issue 
after the initial determination. Therefore, we are proposing to modify 
Sec.  405.1040(b) to state that the ALJ would inform parties who would 
be or were sent a notice of hearing in accordance with Sec.  
405.1020(c). In addition, current Sec.  405.1040(b) does not provide 
for conference notice to be sent to CMS or a contractor that elected to 
be a participant in the proceedings or a party to the hearing at the 
time the conference notice is sent, which has caused confusion when CMS 
or a contractor has made an election before or after a conference. 
Therefore, we are proposing at Sec.  405.1040(b) that a conference 
notice be sent to CMS or a contractor that has elected to be a 
participant in the proceedings or a party to the hearing at the time 
the conference notice is sent. We believe these changes would help 
ensure the appropriate parties and participants are provided with 
notice of, and have an opportunity to attend, a conference. We are 
proposing at Sec.  423.2040(b) and (c) to adopt corresponding revisions 
for prehearing conference notices in non-expedited and expedited 
hearings respectively to state that a conference notice is sent to CMS, 
the IRE, and/or the Part D plan sponsor if the ALJ has granted their 
request(s) to be a participant in the hearing, but we are not proposing 
to make other changes in proposed Sec.  405.1040(b) to Sec.  423.2040 
because only the enrollee is a party in part 423, subpart U 
proceedings. In addition, because an oral request not to receive a 
notice of the conference is permitted for expedited hearings, we are 
proposing at Sec.  423.2040(d) to revise the requirement for an ``ALJ 
hearing office'' to document such an oral request to provide more 
generally that oral requests must be documented, which is generally 
done by the ALJ's support staff, rather than other office staff. In 
addition, we are proposing at Sec.  423.2040(d) that documentation of 
an oral request not to receive written notice of the conference must be 
added to the administrative record for consistency in how the record is 
referenced.
    Current Sec.  405.1040(c) states that, at the conference, the ALJ 
may consider matters in addition to those stated in the notice of 
hearing, if the parties consent in writing. However, OMHA ALJs have 
indicated that providing them with the discretion to delegate 
conducting a conference to an attorney would add efficiency to the 
process. OMHA attorneys are licensed attorneys who support ALJs in 
evaluating appeals and preparing appeals for hearing, as well as 
drafting decisions, and are well versed in Medicare coverage and 
payment policy, as well as administrative procedure. Therefore, we are 
proposing at Sec.  405.1040(c)(1) that, at the conference, the ALJ or 
an OMHA attorney designated by the ALJ may conduct the conference, but 
only the ALJ conducting a conference may consider matters in addition 
to those stated in the conference notice if the parties consent to 
consideration of the additional matters in writing. This revision would 
allow an OMHA attorney designated by the ALJ assigned to an appeal to 
conduct a conference, but would only allow an ALJ conducting the 
conference to consider matters in addition to those stated in the 
conference notice. We believe allowing ALJs to delegate the task of 
conducting a conference (consistent with the conference notice stating 
the purpose of the conference, in accordance with Sec.  405.1040(b)) 
would provide ALJs with the flexibility to use OMHA attorneys and 
provide ALJs with more time to devote to hearings and decisions. We 
also believe using attorneys to conduct conferences is appropriate 
because conferences are informal proceedings to facilitate a hearing or 
decision, and do not involve taking testimony or receiving evidence, 
both of which occur at the hearing. We also note that the results of 
the conference embodied in a conference order are subject to review and 
approval by the ALJ, and ultimately subject to an objection by the 
parties, under the provisions of current Sec.  405.1040, which are 
carried over in proposed Sec.  405.1040. We are proposing at Sec.  
423.2040(e)(1) to adopt corresponding revisions for allowing an ALJ to 
delegate conducting a conference to an OMHA attorney, in part 423, 
subpart U proceedings.
    Current Sec.  405.1040(c) references the notice of hearing in 
discussing the matters that are considered at a conference. However, a 
notice of hearing may not have been issued at the time a prehearing 
conference is scheduled, and the matters being addressed in the appeal 
may have evolved since a notice of hearing was issued by the time a 
posthearing conference is scheduled, resulting in confusion on the 
permissible scope of the matters discussed at a conference. Therefore, 
Sec.  405.1040(c)(1) would state that the matters that are considered 
at a conference are those stated in the conference notice (that is, the 
purpose of the conference, as discussed in current Sec.  405.1040(b)).
    Current Sec.  405.1040(c) states that a record of the conference is 
made. However, that requirement has been read and applied differently 
by adjudicators. We are proposing at Sec.  405.1040(c)(2) to require 
that an audio recording of the conference be made to establish a 
consistent standard and because the audio recording is the most 
administratively efficient way to make a record of the conference. We 
are proposing at Sec.  423.2040(e)(1) and (e)(2) to adopt corresponding 
revisions to reference a conference notice and clarify that an audio 
recording of the conference is made in part 423, subpart U proceedings.
    Current Sec.  405.1040(d) requires the ALJ to issue an order 
stating all agreements and actions resulting from the conference. If 
the parties do not object, the agreements and actions become part of 
the hearing record and are binding on

[[Page 43839]]

all parties. It does not state to whom a conference order is issued, 
and again broadly references parties in indicating who may object to 
the order. In addition, current Sec.  405.1040(d) does not establish a 
time period within which an objection must be made before the order 
becomes part of the record and binding on the parties. Therefore, we 
are proposing to revise Sec.  405.1040(d) to state that the ALJ issues 
an order to all parties and participants who attended the conference 
stating all agreements and actions resulting from the conference. If a 
party does not object within 10 calendar days of receiving the order, 
or any additional time granted by the ALJ, the agreements and actions 
become part of the administrative record and are binding on all 
parties. Proposed Sec.  405.1040(d) would provide that the order is 
issued to the parties and participants who attended the conference to 
help ensure the appropriate parties and participants receive the order, 
but as in current Sec.  405.1040(d), only a party could object to the 
order. Proposed Sec.  405.1040(d) would also establish that an 
objection must be made within 10 calendar days of receiving the order 
to establish a consistent minimum standard for making objection to a 
conference order, but would also provide the ALJ with the discretion to 
grant additional time. In addition, proposed Sec.  405.1040(d) would 
replace ``hearing record'' with ``administrative record'' for 
consistency with other references to the record. Further, proposed 
Sec.  405.1040(d) would continue to only allow the ALJ to issue a 
conference order, because we believe the ALJ should review and approve 
the actions and agreements resulting from the conference, and only an 
ALJ should issue an order that would be binding on the parties, if no 
objection is made. We are proposing at Sec.  423.2040(f) to adopt 
corresponding revisions to clarify to whom a conference order is sent 
and the time frame to object to the order, and to specify that 
agreements and actions resulting from the conference become part of the 
``administrative record'' (rather than ``hearing record'') in part 423, 
subpart U proceedings. However, we are proposing to add that an 
enrollee must object to a conference order within 1 calendar day of 
receiving the order for expedited hearings because of the abbreviated 
time frame under which an expedited hearing and decision must be 
completed.
    We are inviting public comments on these proposals. If you choose 
to comment on the proposals in this section, please include the caption 
``Prehearing and posthearing conferences'' at the beginning of your 
comment.
t. The Administrative Record (Sec. Sec.  405.1042 and 423.2042)
    The administrative record is HHS's record of the administrative 
proceedings, and is initially established by OMHA ALJs and built from 
the records of CMS contractors that adjudicated the claim, or from 
records maintained by SSA in certain circumstances. After adjudication 
by OMHA, the Council may include more documents in the administrative 
record, if a request for Council review is filed or a referral to the 
Council is made. If a party then seeks judicial review, the 
administrative record is certified and presented to the Court as the 
official agency record of the administrative proceedings. The record is 
returned to the custody of CMS contractors or SSA after any 
administrative and judicial review is complete. Current practices in 
creating the administrative record in accordance with current 
Sec. Sec.  405.1042 and 423.2042 vary widely. Given the importance of 
the administrative record, we are proposing to revise Sec. Sec.  
405.1042 and 423.2042 to provide for more consistency and to clarify 
its contents and other administrative matters.
    Current Sec.  405.1042(a)(1) provides that the ALJ makes a complete 
record of the evidence, including the hearing proceedings, if any. 
However, this provision has been limiting and causes confusion in 
developing procedures to ensure the completeness of the record and in 
bringing consistency to how the record is structured because individual 
adjudicators organize the record differently. We are proposing to 
revise Sec.  405.1042(a)(1) to require OMHA to make a complete record 
of the evidence and administrative proceedings on the appealed matter, 
including any prehearing and posthearing conferences, and hearing 
proceedings that were conducted. Proposed Sec.  405.1042(a)(1) would 
vest OMHA, rather than the ALJ, with the responsibility of making a 
complete record of the evidence and administrative proceedings in the 
appealed matter, including any prehearing and posthearing conferences 
and hearing proceedings. This would provide OMHA with more discretion 
to develop polices and uniform procedures for constructing the 
administrative record, while preserving the role of the ALJ or attorney 
adjudicator, as proposed in section II.B above, to identify the 
evidence that was used in making the determinations below and the 
evidence that was used in making his or her decision. We are proposing 
at Sec.  423.2042(a)(1) to also adopt corresponding revisions to 
indicate OMHA makes a complete record of the evidence and 
administrative proceedings in the appealed matter in part 423, subpart 
U proceedings.
    Current Sec.  405.1042(a)(2) discusses which documents in the 
record are marked as exhibits, and provides a non-exhaustive list of 
documents that are marked to indicate that they were considered in 
making the decisions under review or the ALJ's decision. It further 
states that in the record, the ALJ also must discuss any evidence 
excluded under Sec.  405.1028 and include a justification for excluding 
the evidence. We are proposing to revise Sec.  405.1042(a)(2) to state 
that the record would include marked as exhibits, the appealed 
determinations, and documents and other evidence used in making the 
appealed determinations and the ALJ's or attorney adjudicator's 
decision, including, but not limited to, claims, medical records, 
written statements, certificates, reports, affidavits, and any other 
evidence the ALJ or attorney admits. We are proposing that attorney 
adjudicators could mark exhibits because as proposed in section II.B, 
attorney adjudicators would be adjudicating requests for hearing and 
requests for review of a QIC dismissal, and should indicate the 
portions of the record that he or she considered in making the decision 
in the same manner as an ALJ. Proposed Sec.  405.1042(a)(2) would 
continue to require certain evidence to be marked as exhibits, but 
would clarify what would be marked, replacing ``the documents used in 
making the decision under review,'' with ``the appealed determinations, 
and documents and other evidence used in making the appealed 
determinations and the ALJ's or attorney adjudicator's decision.'' We 
believe this would clarify that the exhibited portion of the record 
includes, at minimum, the appealed determinations, documents and other 
evidence used in making the appealed determinations, and documents and 
other evidence used in making the ALJ's or attorney adjudicator's 
decision. The illustrative list of documents that may be marked as 
exhibits pursuant to the rule in current Sec.  405.1042(a)(2) would be 
incorporated in proposed Sec.  405.1042(a)(2) without change. We also 
are proposing to clarify at Sec.  405.1042(a)(2) that the record would 
include any evidence excluded or not considered by the ALJ or attorney 
adjudicator, including, but not limited to, new evidence submitted by a 
provider or supplier, or beneficiary represented by a provider or 
supplier,

[[Page 43840]]

for which no good cause was established, and duplicative evidence 
submitted by a party. All evidence presented should be included in the 
record, even if excluded from consideration, in order to help ensure a 
complete record of the evidence. However, such excluded evidence would 
not be marked as an exhibit because the evidence was not considered in 
making the ALJ's or attorney adjudicator's decision. We are proposing 
at Sec.  423.2042(a)(2) to adopt corresponding revisions to clarify 
what would be exhibited in part 423, subpart U proceedings, except the 
reference to new evidence submitted by a provider or supplier, or 
beneficiary represented by a provider or supplier, for which no good 
cause was established as an example of evidence excluded or not 
considered by the ALJ or attorney adjudicator, because there is no such 
limitation on new evidence in part 423, subpart U proceedings.
    As stated previously, current Sec.  405.1042(a)(2) includes 
requirements to discuss any evidence excluded under current Sec.  
405.1028 and include a justification for excluding the evidence. We are 
proposing in Sec.  405.1042(a)(2) to remove these requirements. We 
believe the requirement to justify excluding the evidence is not 
necessary and is in tension with the requirement for a provider or 
supplier, or beneficiary represented by a provider or supplier, to 
establish good cause for submitting new evidence before it may be 
considered. Section 1869(b)(3) of the Act establishes a general 
prohibition on new evidence that must be overcome, and proposed Sec.  
405.1028 would implement the statute by requiring the party to explain 
why the evidence was not submitted prior to the QIC reconsideration, 
and the ALJ or attorney adjudicator to make a finding of good cause to 
admit the evidence. In place of the current Sec.  405.1042(a)(2) 
requirement, as we discuss later, we are proposing at Sec.  
405.1046(a)(2)(ii) to require that if new evidence is submitted for the 
first time at the OMHA level and subject to a good cause determination 
pursuant to proposed Sec.  405.1028, the new evidence and good cause 
determination would be discussed in the decision. We believe the 
decision is the appropriate place to discuss the new evidence and 
document the good cause determination, and the discussion should focus 
on the good cause determination required by proposed Sec.  405.1028, 
regardless of whether good cause was found. We are not proposing any 
corresponding changes to Sec.  423.2042 because there is no provision 
equivalent to the current Sec.  405.1042(a)(2) requirement to discuss 
any excluded evidence.
    Current Sec.  405.1042(a)(3) provides that a party may review the 
record ``at the hearing,'' or if a hearing is not held, at any time 
before the ALJ's notice of decision is issued. However, this is rarely 
done in practice. More often, a party requests a copy of the record 
prior to the hearing, in accordance with current Sec.  405.1042(b). We 
are proposing to revise Sec.  405.1042(a)(3) to state that a party may 
request and review the record prior to or at the hearing, or if a 
hearing is not held, at any time before the notice of decision is 
issued. This revision would allow a party to request and review a copy 
of the record ``prior to or at the hearing'' to more accurately reflect 
the practices of parties. In addition, proposed Sec.  405.1042(a)(3) 
would remove the reference to an ``ALJ's'' decision in explaining that 
if a hearing is not held, a party may request and review the record at 
any time before the notice of decision is issued, because in that 
circumstance an ALJ or attorney adjudicator, as proposed in section 
II.B, may issue the decision. We are proposing at Sec.  423.2042(a)(3) 
to adopt corresponding revisions for part 423, subpart U proceedings.
    Current Sec.  405.1042(a)(4) provides for the complete record, 
including any recording of the hearing, to be forwarded to the Council 
when a request for review is filed or the case is escalated to the 
Council. However, in noting that the record includes recordings, only a 
recording of the hearing is mentioned. We are proposing at Sec.  
405.1042(a)(4) to add that the record includes recordings of prehearing 
and posthearing conferences in addition to the hearing recordings, to 
reinforce that recordings of conferences are part of the complete 
record. We are proposing at Sec.  423.2042(a)(4) to adopt corresponding 
revisions for part 423, subpart U proceedings.
    Current Sec.  405.1042(b)(1) describes how a party may request and 
receive copies of the record from the ALJ. However, after a case is 
adjudicated, OMHA releases custody of the record and forwards it to a 
CMS contractor or SSA, and the record may go on to the Council for 
another administrative proceeding. This results in confusion for 
parties when they request a copy of the record and OMHA is unable to 
provide it. We are proposing at Sec.  405.1042(b)(1) that a party may 
request and receive a copy of the record from OMHA while an appeal is 
pending at OMHA. We also are proposing at Sec.  405.1042(b)(1) to 
replace the reference to an ``exhibit list'' with a reference to ``any 
index of the administrative record'' to provide greater flexibility in 
developing a consistent structure for the administrative record. We 
also are proposing to change the parallel reference to ``the exhibits 
list'' in Sec.  405.1118 to ``any index of the administrative record.'' 
In addition, proposed Sec.  405.1042(b)(1) would replace the reference 
to a ``tape'' of the oral proceeding with an ``audio recording'' of the 
oral proceeding because tapes are no longer used and a more general 
reference would accommodate future changes in recording formats. We 
also are proposing to replace a parallel reference at Sec.  405.1118 to 
a copy of the ``tape'' of the oral proceedings with a copy of the 
``audio recording'' of the oral proceedings. We are proposing at 
Sec. Sec.  423.2042(b)(1) and 423.2118 to adopt corresponding revisions 
for part 423, subpart U proceedings, but note that current Sec.  
423.2118 refers to a ``CD'' of the oral proceedings.
    Current Sec.  405.1042(b)(2) provides that if a party requests all 
or part of the record from an ALJ and an opportunity to comment on the 
record, the time beginning with the ALJ's receipt of the request 
through the expiration of the time granted for the party's response 
does not count toward the 90 calendar day adjudication period. We are 
proposing to revise Sec.  405.1042(b)(2) to state, if a party requests 
a copy of all or part of the record from OMHA or the ALJ or attorney 
adjudicator and an opportunity to comment on the record, any 
adjudication period that applies in accordance with Sec.  405.1016 is 
extended by the time beginning with the receipt of the request through 
the expiration of the time granted for the party's response. This 
proposed revision would clarify that a party may request a ``copy of'' 
all or part of the record, and would add that the request may be made 
to OMHA, or the ALJ or attorney adjudicator, because a party may 
request a copy of the record before it is assigned to an ALJ or 
attorney adjudicator. In addition, proposed Sec.  405.1042(b)(2) would 
revise the discussion of the effect of requesting an opportunity to 
comment on the record on an adjudication period to remove the specific 
reference to a 90 calendar day adjudication period, because in 
accordance with proposed Sec.  405.1016, an adjudication period may be 
90 or 180 calendar days, or alternatively may be waived by the 
appellant and therefore not apply. We are proposing at Sec.  
423.2042(b)(2) to adopt corresponding revisions for part 423, subpart U 
proceedings.
    Current Sec.  405.1042 does not address the circumstance in which a 
party

[[Page 43841]]

requests a copy of the record but is not entitled to receive some of 
the documents in the record. For example, when an appeal involves 
multiple beneficiaries and one beneficiary requests a copy of the 
record, the records related to other beneficiaries may not be released 
to the requesting beneficiary unless he or she obtains consent from the 
other beneficiaries to release the records that pertain to them. 
Proposed Sec.  405.1042(b)(3) would address the possibility that a 
party requesting a copy of the record is not entitled to receive the 
entire record. Specifically, we are proposing in Sec.  405.1042(b)(3) 
that if a party requests a copy of all or part of the record and the 
record, including any audio recordings, contains information pertaining 
to an individual that the requesting party is not entitled to receive 
(for example, personally identifiable information or protected health 
information), those portions of the record would not be furnished 
unless the requesting party obtains consent from the individual. For 
example, if a beneficiary requests a copy of the record for an appeal 
involving multiple beneficiaries, the portions of the record pertaining 
to the other beneficiaries would not be furnished to the requesting 
beneficiary unless he or she obtains consent from the other 
beneficiaries. We believe proposed Sec.  405.1042(b)(3) would help 
ensure that parties are aware that they may not be entitled to receive 
all portions of the record. We are proposing at Sec.  423.2042(b)(3) to 
adopt corresponding revisions for part 423, subpart U proceedings.
    We are inviting public comments on these proposals. If you choose 
to comment on the proposals in this section, please include the caption 
``The administrative record'' at the beginning of your comment.
u. Consolidated Proceedings (Sec. Sec.  405.1044 and 423.2044)
    Current Sec. Sec.  405.1044 and 423.2044 explain that a 
consolidated hearing may be held at the request of an appellant or on 
the ALJ's own motion, if one or more of the issues to be considered at 
the hearing are the same issues that are involved in another request 
for hearing or hearings pending before the same ALJ, and CMS is 
notified of an ALJ's intention to conduct a consolidated hearing. If a 
consolidated hearing is conducted, current Sec. Sec.  405.1044 and 
423.2044 further provide that the ALJ may make a consolidated decision 
and record for the claims involved in the consolidated hearing, or may 
make a separate decision and record for each claim involved in the 
consolidated hearing. This authority is useful in allowing an ALJ and 
the appellant to conduct a single proceeding on multiple appealed 
claims or other determinations that are before the ALJ, reducing time 
and expense for the appellant and the government to resolve the 
appealed matter. However, the current provisions have caused confusion, 
and have been limiting in circumstances in which no hearing is 
conducted.
    Current Sec.  405.1044 uses the terms ``requests for hearing,'' 
``cases,'' and ``claims'' interchangeably, which has resulted in 
confusion because an appeal, or ``case,'' before an ALJ may involve 
multiple requests for hearing, if an appellant's requests were combined 
into one appeal for administrative efficiency prior to being assigned 
to the ALJ. In addition, a request for hearing may involve one or more 
claims. We are proposing in Sec.  405.1044 to use the term ``appeal'' 
to specify that appeals may be consolidated for hearing, and a single 
decision and record may be made for consolidated appeals. We are 
proposing to use ``appeal'' because an appeal is assigned a unique ALJ 
appeal number, for which a unique decision and record is made. We also 
are proposing to move current Sec.  405.1044(b) to new subsection 
(a)(2), and to also replace the term ``combined'' with ``consolidated'' 
for consistent use in terminology. Further, we are proposing at Sec.  
423.2044 to adopt corresponding revisions to use consistent terminology 
in part 423, subpart U proceedings.
    Current Sec.  405.1044(a) through (d) describes when a consolidated 
hearing may be conducted, the effect on an adjudication period that 
applies to the appeal, and providing notice of the consolidated hearing 
to CMS. Proposed Sec.  405.1044(a) would incorporate current Sec.  
405.1044(a) through (c) to combine the provisions related to a 
consolidated hearing. In addition, proposed Sec.  405.1044(a)(4) would 
replace the current requirement to notify CMS that a consolidated 
hearing will be conducted in current Sec.  405.1044(d) with a 
requirement to include notice of the consolidated hearing in the notice 
of hearing issued in accordance with Sec. Sec.  405.1020 and 405.1022. 
This would help ensure notice is provided to the parties and CMS, as 
well as its contractors, in a consistent manner, and reduce 
administrative burden on ALJs and their staff by combining that notice 
into the existing notice of hearing. We are proposing at Sec.  
423.2044(a) to adopt corresponding revisions for part 423, subpart U 
proceedings.
    Current Sec.  405.1044(e) explains that when a consolidated hearing 
is conducted, the ALJ may consolidate the record and issue a 
consolidated decision, or the ALJ may maintain separate records and 
issue separate decisions on each claim. It also states that the ALJ 
ensures that any evidence that is common to all claims and material to 
the common issue to be decided is included in the consolidated record 
or each individual record, as applicable. However, there has been 
confusion on whether separate records may be maintained and a 
consolidated decision can be issued, as well as what must be included 
with the records when separate records are maintained. Proposed Sec.  
405.1044(b) would incorporate some of current Sec.  405.1044(e) and add 
provisions for making a consolidated record and decision. We are 
proposing at Sec.  405.1044(b)(1) that if the ALJ decides to hold a 
consolidated hearing, he or she may make either a consolidated decision 
and record, or a separate decision and record on each appeal. This 
proposed revision would maintain the current option to make a 
consolidated record and decision, or maintain separate records and 
issue separate decisions, but restructures the provision to highlight 
that these are two mutually exclusive options. This proposal is 
important because issuing a consolidated decision without also 
consolidating the record, or issuing separate decisions when a record 
has been consolidated, complicates effectuating a decision and further 
reviews of the appeal(s). We are proposing in Sec.  405.1044(b)(2) 
that, if a separate decision and record on each appeal is made, the ALJ 
is responsible for making sure that any evidence that is common to all 
appeals and material to the common issue to be decided, and audio 
recordings of any conferences that were conducted and the consolidated 
hearing are included in each individual administrative record. Proposed 
Sec.  405.1044(b)(2) would address the confusion that sometimes results 
in a copy of the audio recording of a consolidated hearing not being 
included in the administrative records of each constituent appeal when 
separate records are maintained, by clarifying that if a separate 
decision and record is made, audio recordings of any conferences that 
were conducted and the consolidated hearing are included in each 
individual record. This proposal is important because the record for 
each individual appeal must be complete. We are proposing at Sec.  
423.2044(b)(1) and (b)(2) to adopt corresponding revisions for part 
423, subpart U proceedings.

[[Page 43842]]

    Current Sec.  405.1044 does not contemplate a consolidated record 
and decision unless a consolidated hearing was conducted, which is 
limiting when multiple appeals for an appellant can be consolidated in 
a decision issued on the record without a hearing. We are proposing to 
add Sec.  405.1044(b)(3), which would provide that, if a hearing would 
not be conducted for multiple appeals that are before the same ALJ or 
attorney adjudicator as proposed in section II.B, and the appeals 
involve one or more of the same issues, the ALJ or attorney adjudicator 
may make a consolidated decision and record at the request of the 
appellant or on the ALJ's or attorney adjudicator's own motion. This 
would provide authority for an ALJ or attorney adjudicator to make a 
consolidated decision and record on the same basis that a consolidated 
hearing may be conducted. We believe this authority would add 
efficiency to the adjudication process when multiple appeals pending 
before the same adjudicator can be decided without conducting a 
hearing. We are proposing at Sec.  423.2044(b)(3) to adopt a 
corresponding provision for part 423, subpart U proceedings.
    Current Sec.  405.1044 also does not clearly address consolidating 
hearings for multiple appellants, including situations in which a 
beneficiary files a request for hearing on the same claim appealed by a 
provider or supplier, and the provider or supplier has other pending 
appeals that could be consolidated pursuant to current Sec.  405.1044. 
The general practice is that a consolidated hearing is conducted for 
the appeals of a single appellant. This is supported by the reference 
to ``an'' appellant in current Sec.  405.1044(b), and helps ensure the 
hearing and record is limited to protected information that the 
appellant is authorized to receive. Therefore, we are proposing to add 
Sec.  405.1044(c) to provide that consolidated proceedings may only be 
conducted for appeals filed by the same appellant, unless multiple 
appellants aggregated claims to meet the amount in controversy 
requirement in accordance with Sec.  405.1006, and the beneficiaries 
whose claims are at issue have all authorized disclosure of their 
protected information to the other parties and any participants. This 
would help ensure that beneficiary information is protected from 
disclosure to parties who are not authorized to receive it, including 
when a beneficiary requests a hearing for the same claim that has been 
appealed by a provider or supplier, and appeals of other beneficiaries' 
claims filed by the provider or supplier are also pending before the 
same ALJ or attorney adjudicator. We are proposing at Sec.  423.2044(c) 
to adopt a corresponding provision for part 423, subpart U proceedings.
    We are inviting public comments on these proposals. If you choose 
to comment on the proposals in this section, please include the caption 
``Consolidated proceedings'' at the beginning of your comment.
v. Notice of Decision and Effect of an ALJ's or Attorney Adjudicator's 
Decision (Sec. Sec.  405.1046, 405.1048, 423.2046, and 423.2048)
    Current Sec. Sec.  405.1046 and 423.2046 describe the requirements 
for a decision and providing notice of the decision, the content of the 
notice, the limitation on a decision that addresses the amount of 
payment for an item or a service, the timing of the decision, and 
recommended decisions. Current Sec. Sec.  405.1048 and 423.2048 
describe the effects of an ALJ's decision. However, the current 
sections only apply to a decision on a request for hearing, leaving 
ambiguities when issuing a decision on a request for review of a QIC or 
IRE dismissal. We are proposing to consolidate the provisions of each 
section that apply to a decision on a request for hearing under 
proposed Sec. Sec.  405.1046(a), 405.1048(a), 423.2046(a) and 
423.2048(a), with further revisions discussed below, and introduce new 
Sec. Sec.  405.1046(b), 405.1048(b), 423.2046(b) and 423.2048(b) to 
address a decision on a request for review of a QIC or IRE dismissal, 
as well as to revise the titles and provisions of the sections to 
expand their coverage to include decisions by attorney adjudicators, as 
proposed in II.B above. We also are proposing to remove current Sec.  
405.1046(d), which addresses the timing of a decision on a request for 
hearing because it is redundant with Sec.  405.1016 and could lead to 
confusion if a different adjudication period applies, such as a 180-
calendar day period for an escalated request for QIC reconsideration, 
or if no adjudication period applies, such as when the period is waived 
by the appellant. Similarly, we are proposing to remove current 
Sec. Sec.  423.2046(a)(1) and (d) because the adjudication time frames 
discussed in the provisions are redundant with provisions in proposed 
Sec.  423.2016. In addition, we are proposing to re-designate current 
Sec. Sec.  405.1046(e) and 423.2046(e), as proposed Sec. Sec.  
405.1046(c) and 423.2046(c) respectively, to reflect the revised 
structure of proposed Sec. Sec.  405.1046 and 423.2046.
    Current Sec.  405.1046 states that an ALJ will issue a decision 
unless a request for hearing is dismissed. We are proposing to revise 
Sec.  405.1046(a) to state that an ALJ or attorney adjudicator would 
issue a decision unless the request for hearing is dismissed or 
remanded in order to accommodate those situations where the ALJ or 
attorney adjudicator remands a case to the QIC. There has been 
confusion regarding the content requirements of the decision itself, as 
well as whether the findings or conclusions in a QIC reconsideration or 
the arguments of the parties may be referenced or adopted in the 
decision by reference. We believe that while the issues that are 
addressed in a decision are guided by the reconsideration, as well as 
the initial determination and redetermination, and a party may present 
arguments in a framework that reflects recommended findings and 
conclusions, the concept of a de novo review requires an ALJ or 
attorney adjudicator to make independent findings and conclusions. To 
address this confusion, we are proposing in Sec.  405.1046(a) to 
require that the decision include independent findings and conclusions 
to clarify that the ALJ or attorney adjudicator must make independent 
findings and conclusions, and may not merely incorporate the findings 
and conclusions offered by others, though the ALJ or attorney 
adjudicator may ultimately make the same findings and conclusions. As 
discussed in and for the reasons stated in section III.A.3.t above, 
proposed Sec.  405.1046(a)(2)(ii) would also require that if new 
evidence was submitted for the first time at the OMHA level and subject 
to a good cause determination pursuant to proposed Sec.  405.1028, the 
new evidence and good cause determination would be discussed in the 
decision. We are proposing at Sec.  423.2046(a) to adopt corresponding 
revisions for decisions on requests for hearing under part 423, subpart 
U, except the proposals related to discussing new evidence and good 
cause determinations related to new evidence because there are no 
current requirements to establish good cause for submitting new 
evidence in part 423, subpart U proceedings.
    Current Sec.  405.1046(a) requires that a decision be mailed. As 
OMHA transitions to a fully electronic case processing and adjudication 
environment, new options for transmitting a decision to the parties and 
CMS contractors may become available, such as through secure portals 
for parties or through inter-system transfers for CMS contractors. We 
are proposing in Sec.  405.1046(a) to revise the requirement that a 
decision be mailed to

[[Page 43843]]

state that OMHA ``mails or otherwise transmits a copy of the 
decision,'' to allow for additional options to transmit the decision as 
technologies develop. We are proposing to revise Sec.  423.2046(a) to 
adopt a corresponding revision for sending a decision under part 423, 
subpart U.
    Current Sec.  405.1046(a) also requires that a copy of the decision 
be sent to the QIC that issued the reconsideration. However, if the 
decision is issued pursuant to escalation of a request for a 
reconsideration, no reconsideration was issued. To address this 
circumstance, we are proposing in Sec.  405.1046(a) that the decision 
would be issued to the QIC that issued the reconsideration or from 
which the appeal was escalated. In addition, we are proposing in Sec.  
405.1046(a) to replace ``reconsideration determination'' with 
``reconsideration'' for consistency in referencing the QIC's action. 
Current Sec.  405.1046(a) also requires that a copy of the decision be 
sent to the contractor that made the initial determination. However, 
this requirement adds to the administrative burden on OMHA and we 
believe is unnecessary in light of the requirement that a copy of the 
decision be sent to the QIC and the original decision is forwarded as 
part of the administrative record to another CMS contractor to 
effectuate the decision. Thus, we are proposing in Sec.  405.1046(a) to 
remove the requirement to send a copy of the decision to the contractor 
that issued the initial determination. In addition, we are proposing in 
Sec.  423.2046(a) to replace ``reconsideration determination'' with 
``reconsideration'' for consistency in referencing the IRE's action in 
part 423, subpart U proceedings, but we are not proposing to 
incorporate other changes proposed for Sec.  405.1046(a) in proposed 
Sec.  423.2046(a) because: (1) escalation is not available in part 423, 
subpart U proceedings; and (2) the Part D plan sponsor, which makes the 
initial coverage determination, has an interest in receiving and 
reviewing ALJ and attorney adjudicator decisions related to an 
enrollee's appeal of drug coverage.
    As discussed above, we are proposing to revise Sec.  405.1046(b) to 
explain the process for making a decision on a request for review of a 
QIC dismissal. In accordance with proposed Sec.  405.1004, we are 
proposing in Sec.  405.1046(b)(1) that unless the ALJ or attorney 
adjudicator dismisses the request for review of a QIC's dismissal or 
the QIC's dismissal is vacated and remanded, the ALJ or attorney 
adjudicator issues a written decision affirming the QIC's dismissal. We 
are proposing in Sec.  405.1046(b)(1) that OMHA would mail or otherwise 
transmit a copy of the decision to all the parties that received a copy 
of the QIC's dismissal because we believe that the QIC would 
appropriately identify the parties who have an interest in the 
dismissal, and that notice of the decision on a request for review of a 
QIC dismissal to any additional parties is unnecessary. We also believe 
that notice to the QIC is not necessary when its dismissal is affirmed 
because it has no further obligation to take action on the request for 
reconsideration that it dismissed. We are proposing in Sec.  
405.1046(b)(2)(i) that the decision affirming a QIC dismissal must 
describe the specific reasons for the determination, including a 
summary of the evidence considered and applicable authorities, but are 
not proposing to require a summary of clinical or scientific evidence 
because such evidence is not used in making a decision on a request for 
a review of a QIC dismissal. In addition, we are proposing that Sec.  
405.1046(b)(2)(ii) and (iii) would explain that the notice of decision 
would describe the procedures for obtaining additional information 
concerning the decision, and would provide notification that the 
decision is binding and not subject to further review unless the 
decision is reopened and revised by the ALJ or attorney adjudicator. We 
are proposing to revise Sec.  423.2046(b) to adopt corresponding 
provisions for a decision on requests for review of an IRE dismissal 
under part 423, subpart U, except that the notice of decision will only 
be sent to the enrollee because only the enrollee is a party.
    We are proposing to revise the title of current Sec.  405.1048 to 
read ``The effect of an ALJ's or attorney adjudicator's decision'' and 
to replace the current introductory statement in Sec.  405.1048(a) that 
``The decision of the ALJ is binding on all parties to the hearing'' 
with ``The decision of the ALJ or attorney adjudicator is binding on 
all parties'' to make the subsection applicable to decisions by 
attorney adjudicators and because the parties are parties to the 
decision regardless of whether a hearing was conducted. We also are 
proposing in Sec.  405.1048(b) that the decision of the ALJ or attorney 
adjudicator on a request for review of a QIC dismissal is binding on 
all parties unless the decision is reopened and revised by the ALJ or 
attorney adjudicator under the procedures explained in Sec.  405.980. 
We are proposing to revise Sec.  423.2048 to adopt corresponding 
provisions for the effects of ALJ and attorney adjudicator decisions 
under part 423, subpart U.
    We are inviting public comments on these proposals. If you choose 
to comment on the proposals in this section, please include the caption 
``Notice of decision and effect of an ALJ's or attorney adjudicator's 
decision'' at the beginning of your comment.
w. Removal of a Hearing Request From an ALJ to the Council (Sec. Sec.  
405.1050 and 423.2050)
    Current Sec. Sec.  405.1050 and 423.2050 explain the process for 
the Council to assume responsibility for holding a hearing if a request 
for hearing is pending before an ALJ. We are proposing to replace ``an 
ALJ'' with ``OMHA'' in the section title, and to replace ``pending 
before an ALJ'' with ``pending before OMHA,'' and ``the ALJ send'' with 
``OMHA send'' in the section text. In accordance with section II.B 
above, these proposed revisions would provide that a request for 
hearing may be removed to the Council regardless of whether the request 
is pending before an ALJ or an attorney adjudicator. We are not 
proposing to replace the last instance of ``ALJ'' in the section text 
because it refers specifically to hearings conducted by an ALJ.
    We are inviting public comments on these proposals. If you choose 
to comment on the proposals in this section, please include the caption 
``Removal of a hearing request from an ALJ to the Council'' at the 
beginning of your comment.
x. Dismissal of a Request for Hearing or Request for Review and Effect 
of a Dismissal of a Request for Hearing or Request for Review 
(Sec. Sec.  405.1052, 405.1054, 423.2052 and 423.2054)
    Current Sec. Sec.  405.1052 and 423.2052 describe the circumstances 
in which a request for hearing may be dismissed and the requirements 
for a notice of dismissal, and current Sec. Sec.  405.1054 and 423.2054 
describe the effect of a dismissal of a request for hearing. However, 
both current sections apply to a dismissal of a request for hearing, 
leaving ambiguities when issuing a dismissal of a request for review of 
a QIC or IRE dismissal. We are proposing to maintain the provisions of 
each section that apply to a dismissal of a request for hearing in 
proposed Sec. Sec.  405.1052(a), 405.1054(a), 423.2052(a) and 
423.2054(a), with further revisions discussed below, and to introduce 
new Sec. Sec.  405.1052(b), 405.1054(b), 423.2052(b) and 423.2054(b) to 
address a dismissal of a request for review of a QIC or IRE dismissal. 
However, we are proposing to re-designate and revise Sec. Sec.  
405.1052(a)(1) and 423.2052(a)(1), as discussed below, and re-designate 
the remaining paragraphs in Sec. Sec.  405.1052(a) and 423.2052(a) 
accordingly. We are also

[[Page 43844]]

proposing to remove the introductory language to current Sec. Sec.  
405.1052 and 423.2052 because it is unnecessary to state that a 
dismissal of a request for hearing is in accordance with the provisions 
of the section, as the provisions are themselves binding authority and 
state in full when a request for hearing may be dismissed. In addition, 
we are proposing to revise the titles of the sections to expand their 
coverage to include dismissals of requests to review a QIC or IRE 
dismissal. Furthermore, we are proposing to re-designate and revise 
current Sec. Sec.  405.1052(b) and 423.2052(b), which describe notices 
of dismissal, as proposed Sec. Sec.  405.1052(d) and 423.2052(d) 
respectively, to reflect the revised structure of proposed Sec. Sec.  
405.1052 and 423.2052. We also are proposing to remove current Sec.  
423.2052(a)(8) and (c) because current Sec.  423.2052(a)(8) restates 
current Sec.  423.1972(c)(1), which already provides that a request for 
hearing will be dismissed if the request itself shows that the amount 
in controversy is not met, and current Sec.  423.2052(c) restates 
current Sec.  423.1972(c)(2), which already provides that if after a 
hearing is initiated, the ALJ finds that the amount in controversy is 
not met, the ALJ discontinues the hearing and does not rule on the 
substantive issues raised in the appeal. We note that a dismissal would 
be warranted in these circumstances pursuant to current Sec.  
423.2052(a)(3), which is carried over as proposed Sec.  423.2052(a)(2) 
because the enrollee does not have a right to a hearing if the amount 
in controversy is not met.
    We are proposing to re-designate and revise current Sec. Sec.  
405.1052(a)(1) and 423.2052(a)(1) as proposed Sec. Sec.  405.1052(c) 
and 423.2052(c) to separately address dismissals based on a party's 
withdrawal. We are proposing in Sec. Sec.  405.1052(c) and 423.2052(c) 
to include withdrawals of requests to review a QIC dismissal because we 
also propose to add provisions to address other dismissals of those 
requests at Sec. Sec.  405.1052(b) and 423.2052(b). We also are 
proposing that an ALJ or attorney adjudicator may dismiss a request for 
review of a QIC dismissal based on a party's withdrawal of his or her 
request because as proposed in section II.B above, both ALJs and 
attorney adjudicators would be able to adjudicate requests to review a 
QIC dismissal. In addition, we are proposing that an ALJ or attorney 
adjudicator may dismiss a request for hearing based on a party's 
withdrawal of his or her request. As discussed in section II.B above, 
we believe that well-trained attorneys can efficiently perform a review 
of these requests and issue dismissals. We believe using attorney 
adjudicators to the maximum extent possible would help OMHA be more 
responsive to appellants and allow ALJs to focus on conducting hearings 
and issuing decisions. We also are proposing to revise the language in 
current Sec. Sec.  405.1052(a)(1) and 423.2052(a)(1) (as redesignated 
in proposed Sec. Sec.  405.1052(c) and 423.2052(c)) to (1) replace 
``notice of the hearing decision'' with ``notice of the decision, 
dismissal or remand'' to reflect that a decision may be issued without 
a hearing, and to reflect other possible outcomes of the proceeding 
(dismissal and remand), and (2) to clarify that a request to withdraw a 
request for hearing may be made orally at a hearing before the ALJ 
because only an ALJ may conduct a hearing.
    Current Sec.  405.1052(a)(2) describes three possible alternatives 
for dismissing a request for hearing when the party that requested the 
hearing, or the party's representative, does not appear at the time and 
place set for the hearing. The current alternatives have caused 
confusion for appellants in understanding whether they are required to 
submit a statement explaining a failure to appear. Further, current 
provisions do not require evidence in the record to document an 
appellant was aware of the time and place of the hearing, and this has 
resulted in remands from the Council. We are proposing to simplify the 
provision to provide two alternatives, and to require that contact has 
been made with an appellant and documented, or an opportunity to 
provide an explanation for failing to appear has been provided before a 
request for hearing is dismissed for failing to appear at the hearing. 
We are proposing at Sec.  405.1052(a)(1)(i) to set forth the first 
alternative which would provide that a request for hearing may be 
dismissed if the party that filed the request was notified before the 
time set for hearing that the request for hearing might be dismissed 
for failure to appear, the record contains documentation that the party 
acknowledged the notice of hearing, and the party does not contact the 
ALJ within 10 calendar days after the hearing or does contact the ALJ 
but does not provide good cause for not appearing. We are proposing at 
Sec.  405.1052(a)(1)(ii) to set forth the second alternative which 
would provide that a request for hearing may be dismissed if the record 
does not contain documentation that the party acknowledged the notice 
of hearing, but the ALJ sends a notice to the party at his or her last 
known address asking why the party did not appear, and the party does 
not respond to the ALJ's notice within 10 calendar days after receiving 
the notice or does respond but does not provide good cause for not 
appearing. In either circumstance, we are maintaining in proposed Sec.  
405.1052(a)(1) the current standard that in determining whether good 
cause exists, the ALJ considers any physical, mental, educational, or 
linguistic limitations that the party may have identified. We believe 
proposed Sec.  405.1052(a)(1) would help ensure that appellants have 
consistent notice of a possible dismissal for failure to appear and an 
opportunity to provide a statement explaining why they did not appear 
before a dismissal is issued. We are proposing to revise Sec.  
423.2052(a)(1) to adopt corresponding revisions for dismissing a 
request for hearing under part 423, subpart U.
    Current OMHA policy provides that a request for hearing that does 
not meet the requirements of current Sec.  405.1014 may be dismissed by 
an ALJ after an opportunity is provided to the appellant to cure an 
identified defect (OMHA Case Processing Manual, division 2, chapter 3, 
section II-3-6 D and E). A dismissal is appropriate because as an 
administrative matter, the proceedings on the request do not begin 
until the information necessary to adjudicate the request is provided 
and the appellant sends a copy of the request to the other parties. 
Additionally, a request cannot remain pending indefinitely once an 
appellant has demonstrated that he or she is unwilling to provide the 
necessary information or to send a copy of the request to the other 
parties. Therefore, we are proposing at Sec.  405.1052(a)(7) to explain 
that a request for hearing may be dismissed if the request is not 
complete in accordance with proposed Sec.  405.1014(a)(1) or the 
appellant did not send copies of its request to the other parties in 
accordance with proposed Sec.  405.1014(d), after the appellant is 
provided with an opportunity to complete the request and/or send copies 
of the request to the other parties. We believe adding this provision 
would emphasize the importance of following the requirements for filing 
a request for hearing, and clarify the outcome if the requirements are 
not met and the appellant does not cure identified defects after being 
provided with an opportunity to do so. We are proposing at Sec.  
423.2052(a)(7) to adopt a corresponding provision for dismissing a 
request for hearing under part 423, subpart U.

[[Page 43845]]

    As discussed above, we are proposing to add Sec.  405.1052(b) to 
explain when a request for review of a QIC dismissal would be 
dismissed. Under proposed Sec.  405.1052(b), a request for review could 
be dismissed in the following circumstances: (1) the person or entity 
requesting the review has no right to the review of the QIC dismissal 
under proposed Sec.  405.1004; (2) the party did not request a review 
within the stated time period and the ALJ or attorney adjudicator has 
not found good cause for extending the deadline; (3) a beneficiary or 
beneficiary's representative filed the request for review and the 
beneficiary passed away while the request for review is pending and all 
of the following criteria apply: (i) a surviving spouse or estate has 
no remaining financial interest in the case, (ii) no other individuals 
or entities have a financial interests in the case and wish to pursue 
an appeal, and (iii) no other individual or entity filed a valid and 
timely request for a review of the QIC dismissal; and (4) the 
appellant's request for review is not complete in accordance with 
proposed Sec.  405.1014(a)(1) or the appellant does not send a copy of 
the request to the other parties in accordance with proposed Sec.  
405.1014(d), after being provided with an opportunity to complete the 
request and/or send a copy of the request to the other parties. We 
believe these provisions would encompass the reasons for dismissing a 
request for a review of a QIC dismissal, and are necessarily 
differentiated from dismissing a request for hearing because, as 
explained in section III.A.3.c above, we do not believe there is a 
right to a hearing for requests for a review of a QIC dismissal. We are 
proposing at Sec.  423.2052(b) to adopt corresponding provisions for 
dismissing requests for a review of an IRE dismissal under part 423, 
subpart U proceedings.
    As discussed above, current Sec.  405.1052(b) describes the 
requirements for providing notice of the dismissal and we are proposing 
to re-designate the paragraph as proposed Sec.  405.1052(d). For the 
same reasons discussed in section III.A.3.v above for allowing a notice 
of a decision to be provided by means other than mail, we are proposing 
in Sec.  405.1052(d) that OMHA may mail or ``otherwise transmit'' 
notice of a dismissal. We are proposing to revise Sec.  423.2052(d) to 
adopt a corresponding revision for notices of dismissal under part 423, 
subpart U.
    Current Sec.  405.1052(b) requires notice of the dismissal to be 
sent to all parties at their last known address. However, we believe 
that requirement is overly inclusive and causes confusion by requiring 
notice of a dismissal to be sent to parties who have not received a 
copy of the request for hearing or request for review that is being 
dismissed. Thus, we are proposing to revise Sec.  405.1052(d) to state 
that the notice of dismissal is sent to the parties who received a copy 
of the request for hearing or request for review because only those 
parties are on notice that a request was pending. In addition, we are 
proposing at Sec.  405.1052(d) that if a party's request for hearing or 
request for review is dismissed, the appeal would proceed with respect 
to any other parties who also filed a valid request for hearing or 
review regarding the same claim or disputed matter. This would address 
the rare circumstance in which more than one party submits a request, 
but the request of one party is dismissed. In that circumstance, the 
appeal proceeds on the request that was not dismissed, and the party 
whose request was dismissed remains a party to the proceedings but does 
not have any rights associated with a party that filed a request, such 
as the right to escalate a request for hearing. We are not proposing a 
corresponding revision to Sec.  423.2052(c) because only the enrollee 
is a party to an appeal under part 423, subpart U.
    Current Sec.  405.1052 does not include authority for an ALJ to 
vacate his or her own dismissal, and instead requires an appellant to 
request the Council review an ALJ's dismissal. As explained in the 2005 
Interim Final Rule (70 FR 11465), the authority for an ALJ to vacate 
his or her own dismissal was not regarded as an effective remedy 
because the record was no longer in the ALJ hearing office, and the 
resolution was complicated when appellants simultaneously asked the ALJ 
to vacate the dismissal order and asked the Council to review the 
dismissal. However, in practice, the lack of the authority for an ALJ 
to vacate his or her own dismissal has constrained ALJs' ability to 
correct erroneous dismissals that can be easily remedied by the ALJ, 
and has caused unnecessary work for the Council. We are proposing to 
add Sec.  405.1052(e) to provide the authority for an ALJ or an 
attorney adjudicator, as proposed in section II.B above, to vacate his 
or her own dismissal within 6 months of the date of the notice of 
dismissal, in the same manner as a QIC can vacate its own dismissal. We 
believe that this authority would reduce unnecessary appeals to the 
Council and provide a more timely resolution of dismissals for 
appellants, whether the dismissal was issued by an ALJ or attorney 
adjudicator. We also note that the coordination for obtaining the 
administrative record and addressing instances in which an appellant 
also requests a review of the dismissal by the Council can be addressed 
through operational coordination among CMS, OMHA, and the DAB. We are 
proposing in Sec.  423.2052(e) to adopt a corresponding provision for 
vacating a dismissal under part 423, subpart U.
    To align the effects of a dismissal with proposed Sec.  
405.1052(e), we are proposing to add Sec.  405.1054(a) to state that 
the dismissal of a request for hearing is binding unless it is vacated 
by the ALJ or attorney adjudicator under Sec.  405.1052(e), in addition 
to the current provision that allows the dismissal to be vacated by the 
Council under Sec.  405.1108(b). To explain the effect of a dismissal 
of a request for review of a QIC dismissal, consistent with Sec.  
405.1004, we are proposing in Sec.  405.1054(b) to provide that the 
dismissal of a request for review of a QIC dismissal of a request for 
reconsideration is binding and not subject to further review unless it 
is vacated by the ALJ or attorney adjudicator under Sec.  405.1052(e). 
We are proposing in Sec.  423.2054 to adopt corresponding revisions for 
the effect of dismissals of request for hearing and requests for review 
of an IRE dismissal under part 423, subpart U.
    We are inviting public comments on these proposals. If you choose 
to comment on the proposals in this section, please include the caption 
``Dismissal of a request for hearing or request for review and effect 
of a dismissal of a request for hearing or request for review'' at the 
beginning of your comment.
4. Applicability of Medicare Coverage Policies (Sec. Sec.  405.1060, 
405.1062, 405.1063, 423.2062, 423.2063)
    Current Sec.  405.1060 addresses the applicability of national 
coverage determinations (NCDs) to claim appeals brought under part 405, 
subpart I and provides that an ALJ and the Council may not disregard, 
set aside, or otherwise review an NCD, but may review the facts of a 
particular case to determine whether an NCD applies to a specific claim 
for benefits and, if so, whether the NCD was applied correctly to the 
claim. Current Sec.  405.1062 addresses the applicability of local 
coverage determinations (LCDs) and other policies, and specifies that 
ALJs and the Council are not bound by LCDs, local medical review 
policies (LMRPs), or CMS program guidance, such as program memoranda 
and manual instructions, but will give substantial deference to these 
policies if they are

[[Page 43846]]

applicable to a particular case, and if an ALJ or the Council declines 
to follow a policy in a particular case, the ALJ or the Council must 
explain the reasons why the policy was not followed. Similarly, current 
Sec.  423.2062 states that ALJs and the Council are not bound by CMS 
program guidance but will give substantial deference to these policies 
if they are applicable to a particular case, and if an ALJ or the 
Council declines to follow a policy in a particular case, the ALJ or 
the Council must explain the reasons why the policy was not followed. 
Current Sec. Sec.  405.1062 and 423.2062 also provide that an ALJ or 
Council decision to disregard a policy applies only to the specific 
claim being considered and does not have precedential effect. Further, 
Sec.  405.1062 states that an ALJ or the Council may not set aside or 
review the validity of an LMRP or LCD for purposes of a claim appeal. 
Current Sec. Sec.  405.1063 and 423.2063 address the applicability of 
laws, regulations, and CMS Rulings, and provide that all laws and 
regulations pertaining to the Medicare program (and for Sec.  405.1063 
the Medicaid program as well), including but not limited to Titles XI, 
XVIII, and XIX of the Act and applicable implementing regulations, are 
binding on ALJs and the Council, and consistent with Sec.  401.108, CMS 
Rulings are binding on all HHS components that adjudicate matters under 
the jurisdiction of CMS.
    We are proposing to revise Sec. Sec.  405.1060, 405.1062, 405.1063, 
423.2062, and 405.2063 to replace ``ALJ'' or ``ALJs'' with ``ALJ or 
attorney adjudicator'' or ``ALJs or attorney adjudicators'' except in 
the second sentence of Sec.  405.1062(c). As proposed in section II.B 
above, an attorney adjudicator would issue certain decisions and 
dismissals and therefore would apply the authorities addressed by these 
sections. Requiring the attorney adjudicators to apply the authorities 
in the same manner as an ALJ would provide consistency in the 
adjudication process, regardless of who is assigned to adjudicate a 
request for an ALJ hearing or request for review of a QIC or IRE 
dismissal. We are not proposing to revise the second sentence in 
current Sec.  405.1062(c) because attorney adjudicators would not 
review or set aside an LCD (or any part of an LMRP that constitutes an 
LCD) in accordance with part 426 (part 426 appeals are currently heard 
by ALJs in the Civil Remedies Division of the DAB).
    We are inviting public comments on these proposals. If you choose 
to comment on the proposals in this section, please include the caption 
``Applicability of Medicare Coverage Policies'' at the beginning of 
your comment.
5. Council Review and Judicial Review
a. Council Review: General (Sec. Sec.  405.1100, 423.1974 and 423.2100)
    Current Sec.  405.1100 discusses the Council review process. 
Current Sec.  405.1100(a) states that the appellant or any other party 
to the hearing may request that the Council review an ALJ's decision or 
dismissal. We are proposing to revise Sec.  405.1100(a) to replace 
``the hearing'' with ``an ALJ's or attorney adjudicator's decision or 
dismissal,'' and ``an ALJ's decision or dismissal,'' with ``the ALJ's 
or attorney adjudicator's decision or dismissal'' because the parties 
are parties to the proceedings and the resulting decision or dismissal 
regardless of whether a hearing is conducted, and as proposed in 
section II.B above, an attorney adjudicator would be able to issue 
certain decisions or dismissals for which Council review maybe 
requested.
    Current Sec.  423.1974 states that an enrollee who is dissatisfied 
with an ALJ hearing decision may request that the Council review the 
ALJ's decision or dismissal as provided in Sec.  423.2102, and current 
Sec.  423.2100(a) states that consistent with Sec.  423.1974, the 
enrollee may request that the Council review an ALJ's decision or 
dismissal. We are proposing to revise Sec.  423.1974 to replace ``ALJ 
hearing decision'' with ``an ALJ's or attorney adjudicator's decision 
or dismissal,'' and to revise Sec. Sec.  423.1974 and 423.2100(a) to 
replace ``ALJ's decision or dismissal'' with ``an ALJ's or attorney 
adjudicator's decision or dismissal'' because the parties are parties 
to the proceedings and resulting decision or dismissal regardless of 
whether a hearing is conducted, and as proposed in section II.B above, 
an attorney adjudicator may issue a decision or dismissal for which 
Council review maybe requested.
    Current Sec.  405.1100(b) provides that under the circumstances set 
forth in Sec. Sec.  405.1104 and 405.1108, an appellant may request 
escalation of a case to the Council for a decision even if the ALJ has 
not issued a decision or dismissal in his or her case. We are proposing 
to revise Sec.  405.1100(b) to provide that under circumstances set 
forth in Sec. Sec.  405.1016 and 405.1108, the appellant may request 
that a case be escalated to the Council for a decision even if the ALJ 
or attorney adjudicator has not issued a decision, dismissal, or remand 
in his or her case. These revisions would reference Sec.  405.1016, 
which, as discussed in section III.A.3.h above, would replace the 
current Sec.  405.1104 provisions for escalating a case from the OMHA 
level to the Council. They would also provide that in addition to 
potentially issuing a decision or dismissal, an ALJ or attorney 
adjudicator, as proposed in section II.B above, may issue a remand--
this would present a complete list of the actions that an ALJ or 
attorney adjudicator could take on an appeal.
    Current Sec. Sec.  405.1100(c) and 423.2100(b) and (c) state in 
part that when the Council reviews an ALJ's decision, it undertakes a 
de novo review, and the Council issues a final decision or dismissal 
order or remands a case to the ALJ. We are proposing to revise 
Sec. Sec.  405.1100(c) and 423.2100(b) and (c) to state that when the 
Council reviews an ALJ's or attorney adjudicator's decision, it 
undertakes a de novo review and may remand a case to an ALJ or attorney 
adjudicator, so that the same standard for review is applied to ALJ and 
attorney adjudicator decisions. We are also proposing to revise 
Sec. Sec.  405.1100(c) and 423.2100(c) to state that the Council may 
remand an attorney adjudicator's decision to the attorney adjudicator 
so that like an ALJ, the attorney adjudicator can take the appropriate 
action ordered by the Council (however, if the Council were to order 
that a hearing must be conducted, the case would be transferred to an 
ALJ upon remand to the attorney adjudicator because only an ALJ may 
conduct a hearing).
    Current Sec.  423.2100(c) and (d) provide that the Council issues a 
final decision, dismissal order, or remand no later than the period of 
time specified in the respective paragraph, beginning on the date that 
the request for review is received by the entity specified in the ALJ's 
written notice of decision. We are proposing to revise Sec.  
423.2100(c) and (d) to state that the period of time begins on the date 
that the request for review is received by the entity specified in the 
ALJ's or attorney adjudicator's written notice of decision because an 
attorney adjudicator may also issue a decision, as proposed in section 
II.B above. We are also proposing to revise Sec.  423.2100(c) to 
correct a typographical error by inserting ``day'' into the current 
``90 calendar period,'' so it is clear to enrollees that the period of 
time being referenced is the 90 calendar day period.
    Current Sec.  405.1100(d) states in part that when deciding an 
appeal that was escalated from the ALJ level to the Council, the 
Council will issue a final decision or dismissal order or remand order 
within 180 calendar days of receipt of the appellant's request for 
escalation. A remand from the Council

[[Page 43847]]

after an appeal is escalated to it is exceedingly rare and done in 
circumstances in which the Council must remand to an ALJ so that the 
ALJ may obtain information under current Sec.  405.1034 that is missing 
from the written record and essential to resolving the issues on 
appeal, and that information can only be provided by CMS or its 
contractors, because the Council does not have independent authority to 
obtain the information from CMS or its contractors. In addition, an 
appeal may have not yet have been assigned to an ALJ, or could be 
assigned to an attorney adjudicator as proposed in section II.B above, 
when the appeal was escalated by the appellant. We are proposing to 
revise Sec.  405.1100(d) to state that if the Council remands an 
escalated appeal, the remand is to the OMHA Chief ALJ because the rare 
and unique circumstances in which an escalated appeal is remanded by 
the Council require immediate attention that the OMHA Chief ALJ is 
positioned to provide to minimize delay for the appellant, and to 
minimize confusion if the case was not assigned to an ALJ or attorney 
adjudicator when it was escalated.
    We are inviting public comments on these proposals. If you choose 
to comment on the proposals in this section, please include the caption 
``Medicare Appeals Council review: general'' at the beginning of your 
comment.

b. Request for Council Review When the ALJ Issues Decision or Dismissal 
(Sec. Sec.  405.1102 and 423.2102)

    Current Sec. Sec.  405.1102 and 423.2102 discuss requests for 
Council review when an ALJ issues a decision or dismissal. Current 
Sec. Sec.  405.1102(a)(1) and 423.2102(a)(1) provide that a party or 
enrollee, respectively, to ``the ALJ hearing'' may request a Council 
review if the party or enrollee files a written request for a Council 
review within 60 calendar days after receipt of the ALJ's decision or 
dismissal, which is in accordance with the criteria specified in 
current Sec. Sec.  405.1102 and 423.2102. However, a party or enrollee 
is a party to the proceedings and resulting decision or dismissal, and 
may appeal the decision or dismissal regardless of whether a hearing 
was conducted in the appeal, and as proposed in section II.B above, an 
attorney adjudicator may issue a decision or dismissal for which 
Council review may be requested. To help ensure there is no confusion 
that a party or enrollee may seek Council review even if a hearing 
before an ALJ is not conducted or if an attorney adjudicator issues the 
decision or dismissal, we are proposing to revise Sec. Sec.  
405.1102(a)(1) and 423.2102(a)(1) to state a party or enrollee to a 
decision or dismissal issued by an ALJ or attorney adjudicator may 
request Council review if the party or enrollee files a written request 
for a Council review within 60 calendar days after receipt of the ALJ's 
or attorney adjudicator's decision or dismissal.
    Current Sec. Sec.  405.1102(c) and 423.2102(c) provide that a party 
or enrollee, respectively, does not have a right to seek Council review 
of an ALJ's remand to a QIC or IRE, or an ALJ's affirmation of a QIC's 
or IRE's dismissal of a request for reconsideration. However, under 
current Sec. Sec.  405.1004(c) and 423.2004(c), a party or enrollee, 
respectively, may currently seek Council review of a dismissal of a 
request for review of a QIC or IRE dismissal because, as discussed in 
section III.A.3.x above, an ALJ does not currently have the authority 
to vacate his or her own dismissal. As proposed in section II.B above, 
an attorney adjudicator could adjudicate requests for a review of a QIC 
or IRE dismissal. In addition, proposed Sec. Sec.  405.1052(e) and 
423.2052(e) would establish the authority for an ALJ or attorney 
adjudicator to vacate his or her own dismissal, and in accordance with 
the policy that a review of a dismissal is only reviewable at the next 
level of appeal, as discussed in section III.A.3.c above, proposed 
Sec. Sec.  405.1102(c) and 423.2102(c) would be revised to indicate 
that a party does not have the right to seek Council review of an ALJ's 
or attorney adjudicator's dismissal of a request for review of a QIC 
dismissal. Therefore, we are proposing at Sec. Sec.  405.1102(c) and 
423.2102(c) to add that a party does not have the right to seek Council 
review of an ALJ's or attorney adjudicator's remand to a QIC or IRE, 
affirmation of a QIC's or IRE's dismissal of a request for 
reconsideration, or dismissal of a request for review of a QIC or IRE 
dismissal.
    We are inviting public comments on these proposals. If you choose 
to comment on the proposals in this section, please include the caption 
``Request for Council review when ALJ issues decision or dismissal'' at 
the beginning of your comment.

c. Where a Request for Review or Escalation May Be Filed (Sec. Sec.  
405.1106 and 423.2106)

    Current Sec. Sec.  405.1106(a) and 423.2106 provide that when a 
request for a Council review is filed after an ALJ has issued a 
decision or dismissal, the request for review must be filed with the 
entity specified in the notice of the ALJ's action, and under Sec.  
405.1106, the appellant must also send a copy of the request for review 
to the other parties to the ALJ decision or dismissal who received a 
copy of the hearing decision or notice of dismissal. The sections also 
explain that if the request for review is timely filed with an entity 
other than the entity specified in the notice of the ALJ's action, the 
Council's adjudication period to conduct a review begins on the date 
the request for review is received by the entity specified in the 
notice of the ALJ's action, and upon receipt of a request for review 
from an entity other than the entity specified in the notice of the 
ALJ's action, the Council sends written notice to the appellant of the 
date of receipt of the request and commencement of the adjudication 
time frame. In addition, current Sec.  405.1106(b) discusses that if an 
appellant files a request to escalate an appeal to the Council because 
the ALJ has not completed his or her action on the request for hearing 
within the adjudication deadline under Sec.  405.1016, the request for 
escalation must be filed with both the ALJ and the Council, and the 
appellant must also send a copy of the request for escalation to the 
other parties and failure to copy the other parties tolls the Council's 
adjudication deadline set forth in Sec.  405.1100 until all parties to 
the hearing receive notice of the request for Council review.
    We are proposing in Sec. Sec.  405.1106 and 423.2106 to replace all 
instances of ``ALJ'' with ``ALJ or attorney adjudicator,'' ``ALJ's 
action'' with ``ALJ's or attorney adjudicator's action,'' to provide 
that the sections apply to decisions and dismissals issued by an 
attorney adjudicator as well, as proposed in section II.B, and 
therefore appellants would have the same right to seek Council review 
of the attorney adjudicator's decision or dismissal, and the Council 
would have the authority to take the same actions in reviewing an 
attorney adjudicator's decision or dismissal. We are also proposing to 
replace ``a copy of the hearing decision under Sec.  405.1046(a) or a 
copy of the notice of dismissal under Sec.  405.1052(b)'' in Sec.  
405.1106(a) with ``notice of the decision or dismissal,'' because 
Sec. Sec.  405.1046 and 405.1052 provide for notice of a decision or 
dismissal, respectively, to be sent, and a decision or dismissal may be 
issued by an ALJ or attorney adjudicator without conducting a hearing. 
In addition, in describing the consequences of failing to send a copy 
of the request for review to the other parties, we are proposing to 
replace ``until all parties to the hearing'' in

[[Page 43848]]

Sec.  405.1106(a) to ``until all parties to the ALJ or attorney 
adjudicator decision or dismissal,'' to align the language with the 
preceding sentences.
    We are proposing to revise Sec.  405.1106(b) to align the paragraph 
with the revised escalation process proposed at Sec.  405.1016 (see 
section III.A.3.h.i above). Specifically, we are proposing to revise 
Sec.  405.1106(b) to state that if an appellant files a request to 
escalate an appeal to the Council level because the ALJ or attorney 
adjudicator has not completed his or her action on the request for 
hearing within an applicable adjudication period under Sec.  405.1016, 
the request for escalation must be filed with OMHA and the appellant 
must also send a copy of the request for escalation to the other 
parties who were sent a copy of the QIC reconsideration. This proposed 
revision would align this section with the revised process in proposed 
Sec.  405.1016 by specifying that the request for escalation is filed 
with OMHA and removing the requirement for an appellant to also file 
the request with the Council. In addition, proposed Sec.  405.1106(b) 
would specify that the request for escalation must be sent to the other 
parties who were sent a copy of the QIC reconsideration, which would 
align with the parties to whom the appellant is required to send a copy 
of its request for hearing. Proposed Sec.  405.1106(b) would also refer 
to ``an applicable adjudication period'' under Sec.  405.1016, to align 
the terminology and because an adjudication period may not apply to a 
specific case (for example, if the appellant waived an applicable 
adjudication time frame). Finally, proposed Sec.  405.1106(b) would 
provide that failing to copy the other parties would toll the Council's 
adjudication deadline until all parties who were sent a copy of the QIC 
reconsideration receive notice of the request for escalation, rather 
than notice of the request for Council review as is currently required, 
because the revised escalation process proposed at Sec.  405.1016 would 
remove the requirement to file a request for Council review when 
escalation is requested from the OMHA to the Council level.
    We are inviting public comments on these proposals. If you choose 
to comment on the proposals in this section, please include the caption 
``Where a request for review or escalation may be filed'' at the 
beginning of your comment.

d. Council Actions When Request for Review or Escalation Is Filed 
(Sec. Sec.  405.1108 and 423.2108)

    Current Sec. Sec.  405.1108 and 423.2108 describe the actions the 
Council may take upon receipt of a request for review or, for Sec.  
405.1108, a request for escalation. We are proposing at Sec.  
405.1108(d) introductory text to replace ``ALJ level'' with ``OMHA 
level'' to provide that the Council's actions with respect to a request 
for escalation are the same regardless of whether the case was pending 
before an ALJ or attorney adjudicator, or unassigned at the time of 
escalation. We are also proposing at Sec.  405.1108(d)(3) to replace 
``remand to an ALJ for further proceedings, including a hearing'' with 
``remand to OMHA for further proceedings, including a hearing'' because 
we believe the Council could remand an escalated case to an ALJ or 
attorney adjudicator for further proceedings, but if the Council 
ordered that a hearing be conducted, the case would need to be remanded 
to an ALJ. We are not proposing any corresponding changes to Sec.  
423.2108 because escalation is not available for Part D coverage 
appeals.
    We are also proposing in Sec. Sec.  405.1108(b) and 423.2108(b), to 
provide that the dismissal for which Council review may be requested is 
a dismissal of a request for a hearing, because as discussed in section 
III.A.3.x above, proposed Sec. Sec.  405.1054(b) and 423.2054(b) would 
provide that a dismissal of a request for a review of a QIC or IRE 
dismissal of a request for reconsideration is binding and not subject 
to further review. Finally, we are proposing to replace all remaining 
references in Sec. Sec.  405.1108 and 423.2108 to ``ALJ'' with ``ALJ or 
attorney adjudicator'' and ``ALJ's'' with ``ALJ's or attorney 
adjudicator's'' to further provide that the Council's actions with 
respect to a request for review or escalation are the same for cases 
that were decided by or pending before an ALJ or an attorney 
adjudicator.
    We are inviting public comments on these proposals. If you choose 
to comment on the proposals in this section, please include the caption 
``Council actions when request for review or escalation is filed'' at 
the beginning of your comment.
e. Council Reviews on Its Own Motion (Sec. Sec.  405.1110 and 423.2110)
    Current Sec. Sec.  405.1110 and 423.2110 discuss Council reviews on 
its own motion. Current Sec. Sec.  405.1110(a) and 423.2110(a) state 
the general rule that the Council may decide on its own motion to 
review a decision or dismissal issued by an ALJ, and CMS or its 
contractor, including the IRE, may refer a case to the Council within 
60 calendar days after the date of the ALJ's decision or dismissal (for 
Sec.  405.1110(a)) or after the ALJ's written decision or dismissal is 
issued (for Sec.  423.2110(a)). Current Sec. Sec.  405.1110(b) and 
423.2110(b) provide the standards for CMS or its contractors to refer 
ALJ decisions and dismissals to the Council for potential review under 
the Council's authority to review ALJ decisions and dismissals on the 
Council's own motion, and require that a copy of a referral to the 
Council be sent to the ALJ whose decision or dismissal was referred, 
among others. Current Sec. Sec.  405.1110(c) and 423.2110(c) explain 
the standards of review used by the Council in reviewing the ALJ's 
action. Current Sec. Sec.  405.1110(d) and 423.2110(d) explain the 
actions the Council may take, including remanding the case to the ALJ 
for further proceedings, and state that if the Council does not act on 
a referral within 90 calendar days after receipt of the referral 
(unless the 90 calendar day period has been extended as provided in the 
respective subpart), the ALJ's decision or dismissal is binding (Sec.  
405.1110(d) further specifies that the decision or dismissal is binding 
on the parties to the decision).
    We are proposing at Sec. Sec.  405.1110 and 423.2110 to replace 
each instance of ``at the ALJ level'' with ``at the OMHA level'' and 
``ALJ proceedings'' with ``OMHA proceedings''. We believe the standards 
for referral to the Council by CMS or its contractor would be the same 
regardless of whether the case was decided by an ALJ or an attorney 
adjudicator, and that ``at the OMHA level'' and ``OMHA proceedings'' 
would reduce confusion in situations where the case was decided by an 
attorney adjudicator. We are proposing at Sec.  405.1110(b)(2) to 
replace the references to current Sec.  405.1052(b) with references to 
Sec.  405.1052(d) to reflect the structure of proposed Sec.  405.1052, 
and are also proposing to revise Sec. Sec.  405.1110(b)(2) and 
423.2110(b)(2)(ii) to state that CMS (in Sec.  405.1110(b)(2)) or CMS 
or the IRE (in Sec.  423.2110(b)(2)(ii)) sends a copy of its referral 
to the OMHA Chief ALJ. The current requirement to send a copy of the 
referral to the ALJ is helpful in allowing OMHA ALJs to review the 
positions that CMS is advocating before the Council, but at times has 
caused confusion as to whether the ALJ should respond to the referral 
(there is no current provision that allows the Council to consider a 
statement in response to the referral). In

[[Page 43849]]

addition, the proposed revision would allow OMHA to collect information 
on referrals, assess whether training or policy clarifications for OMHA 
adjudicators are necessary, and disseminate the referral to the 
appropriate ALJ or attorney adjudicator for his or her information. We 
are also proposing at Sec.  405.1110(b)(2) to replace ``all other 
parties to the ALJ's decision'' with ``all other parties to the ALJ's 
or attorney adjudicator's action'' and at Sec.  405.1110(d) to replace 
``ALJ decision'' with ``ALJ or attorney adjudicator action'' to 
encompass both decisions and dismissals issued by an ALJ or an attorney 
adjudicator, as proposed in section II.B above. We believe that parties 
to an ALJ's dismissal or an attorney adjudicator's decision or 
dismissal have the same right to receive a copy of another party's 
written exceptions to an agency referral as the parties to an ALJ's 
decision, and that an ALJ's or attorney adjudicator's decision or 
dismissal is binding on the parties to the action. We are proposing to 
replace each remaining instance in Sec. Sec.  405.1110 and 423.2110 of 
``ALJ'' with ``ALJ or attorney adjudicator,'' ``ALJ's decision or 
dismissal'' with ``ALJ's or attorney adjudicator's decision or 
dismissal,'' ``ALJ's decision'' with ``ALJ's or attorney adjudicator's 
decision or dismissal,'' and ``ALJ's action'' with ``ALJ's or attorney 
adjudicator's action.'' These proposed revisions would provide that the 
sections apply to decisions and dismissals issued by an attorney 
adjudicator, as proposed in section II.B, and therefore CMS and its 
contractors would have the same right to refer attorney adjudicator 
decisions and dismissals to the Council, and the Council would have the 
authority to take the same actions and have the same obligations in 
deciding whether to review an attorney adjudicator's decision or 
dismissal on its own motion.
    Finally, we are proposing at Sec.  423.2110(b)(1) to replace 
``material to the outcome of the claim'' with ``material to the outcome 
of the appeal'' because unlike Part A and Part B, no ``claim'' is 
submitted for drug coverage under Part D.
    We are inviting public comments on these proposals. If you choose 
to comment on the proposals in this section, please include the caption 
``Council reviews on its own motion'' at the beginning of your comment.
f. Content of Request for Review (Sec. Sec.  405.1112 and 423.2112)
    Current Sec. Sec.  405.1112 and 423.2112 discuss the content of a 
request for Council review. Current Sec.  405.1112(a) requires a 
request for Council review to contain the date of the ALJ's decision or 
dismissal order, if any, among other information. Current Sec.  
423.2112(a)(1) states that the request for Council review must be filed 
with the entity specified in the notice of the ALJ's action. Current 
Sec. Sec.  405.1112(b) and 423.2112(b) state that the request for 
review must identify the parts of the ALJ action with which the party 
or enrollee, respectively, requesting review disagrees and explain why 
he or she disagrees with the ALJ's decision, dismissal, or other 
determination being appealed. Current Sec.  405.1112(b) provides an 
example that if the party requesting review believes that the ALJ's 
action is inconsistent with a statute, regulation, CMS Ruling, or other 
authority, the request for review should explain why the appellant 
believes the action is inconsistent with that authority. Current 
Sec. Sec.  405.1112(c) and 423.2112(c) state that the Council will 
limit its review of an ALJ's action to those exceptions raised by the 
party or enrollee, respectively, in the request for review, unless the 
appellant is an unrepresented beneficiary or the enrollee is 
unrepresented. We are proposing at Sec. Sec.  405.1112 and 423.2112 to 
replace ``ALJ's decision or dismissal'' with ``ALJ's or attorney 
adjudicator's decision or dismissal,'' ``ALJ action'' with ``ALJ or 
attorney adjudicator's action,'' ``ALJ's action'' with ``ALJ's or 
attorney adjudicator's action.'' These proposed revisions would provide 
that the sections apply to decisions and dismissals issued by an 
attorney adjudicator, as proposed in section II.B, and therefore 
information on the attorney adjudicator's decision and dismissal must 
be included in the request for Council review, and the scope of the 
Council's review would be the same as for an ALJ's decision or 
dismissal.
    Current Sec.  405.1112(a) states that a request for Council review 
must be filed with the Council or appropriate ALJ hearing office. 
However, this provision may cause confusion when read with current 
Sec.  405.1106(a), which states that a request for review must be filed 
with the entity specified in the notice of the ALJ's action. In 
practice, OMHA notices of decision and dismissal provide comprehensive 
appeal instructions directing requests for Council review to be filed 
directly with the Council, and provide address and other contact 
information for the Council. Therefore, we are proposing to revise 
Sec.  405.1112(a) to state that the request for Council review must be 
filed with the entity specified in the notice of the ALJ's or attorney 
adjudicator's action, which would to align Sec.  405.1112(a) with 
current Sec.  405.1106(a), and reaffirm that a request for Council 
review must be filed with the entity specified in the notice of the 
ALJ's or attorney adjudicator's action.
    Current Sec.  405.1112(a) also states that the written request for 
review must include the hearing office in which the appellant's request 
for hearing is pending if a party is requesting escalation from an ALJ 
to the Council. In light of the proposed revisions to the escalation 
process discussed in section III.A.3.h.i above, we are proposing to 
remove this requirement from Sec.  405.1112(a) because proposed Sec.  
405.1016 would provide that a request for escalation is filed with 
OMHA. In accordance with proposed Sec.  405.1016, if the request for 
escalation meets the requirements of Sec.  405.1016(f)(1) and a 
decision, dismissal, or remand cannot be issued within 5 calendar days 
after OMHA receives the request, the appeal would be forwarded to the 
Council.
    We are inviting public comments on these proposals. If you choose 
to comment on the proposals in this section, please include the caption 
``Content of request for review'' at the beginning of your comment.
g. Dismissal of Request for Review (Sec. Sec.  405.1114 and 423.2114)
    We are proposing at Sec.  405.1114(c)(3) to replace ``ALJ hearing'' 
with ``ALJ's or attorney adjudicator's action.'' This proposed revision 
would provide that the paragraph applies to decisions and dismissals 
issued by an attorney adjudicator, as proposed in section II.B, and 
therefore a valid and timely request for Council review filed by 
another party to an attorney adjudicator's decision or dismissal would 
preclude dismissal of a request for Council review under Sec.  
405.1114(c). We are not proposing any corresponding changes to Sec.  
423.1114 because there is no provision equivalent to current Sec.  
405.1114(c)(3).
    We are inviting public comments on these proposals. If you choose 
to comment on the proposals in this section, please include the caption 
``Dismissal of request for review'' at the beginning of your comment.
h. Effect of Dismissal of Request for Council Review or Request for 
Hearing (Sec. Sec.  405.1116 and 423.2116)
    Current Sec. Sec.  405.1116 and 423.2116 describe the effect of a 
dismissal by the Council of a request for Council review or a request 
for hearing. We are proposing to replace ``ALJ'' with ``ALJ or attorney 
adjudicator'' to provide that the denial of a request for Council 
review of a dismissal issued by an attorney

[[Page 43850]]

adjudicator is binding and not subject to judicial review in the same 
manner as the denial of a request for Council review of a dismissal 
issued by an ALJ. We believe the Council's denial of a request to 
review an attorney adjudicator's dismissal would be subject to the same 
general rules described in sections III.A.3.c and III.A.3.x above 
pertaining to reviews of dismissals at the next adjudicative level, and 
that further review of the attorney adjudicator's dismissal in Federal 
district court would be unavailable.
    We are inviting public comments on these proposals. If you choose 
to comment on the proposals in this section, please include the caption 
``Effect of dismissal of request for Council review or request for 
hearing'' at the beginning of your comment.
i. Obtaining Evidence From the Council (Sec. Sec.  405.1118 and 
423.2118)
    Current Sec. Sec.  405.1118 and 423.2118 provide that a party or an 
enrollee, respectively, may request and receive a copy of all or part 
of the record of the ALJ hearing. We are proposing to replace ``ALJ 
hearing'' with ``ALJ's or attorney adjudicator's action.'' This 
proposed revision would provide that a party to an attorney adjudicator 
action, or to an ALJ decision that was issued without a hearing, may 
request and receive a copy of all or part of the record to the same 
extent as a party to an ALJ hearing. We are also proposing to replace 
the reference to an ``exhibits list'' with a reference to ``any index 
of the administrative record'' to provide greater flexibility in 
developing a consistent structure for the administrative record. In 
addition, we are proposing at Sec.  405.1118 to replace the reference 
to a ``tape'' of the oral proceeding with an ``audio recording'' of the 
oral proceeding because tapes are no longer used and a more general 
reference would accommodate future changes in recording formats. We are 
proposing a parallel revision to Sec.  423.2118 to replace the 
reference to a ``CD'' of the oral proceeding with an ``audio 
recording'' of the oral proceeding.
    We are inviting public comments on these proposals. If you choose 
to comment on the proposals in this section, please include the caption 
``Obtaining evidence from the Council'' at the beginning of your 
comment.
j. What Evidence May Be Submitted to the Council (Sec. Sec.  405.1122 
and 423.2122)
    Current Sec. Sec.  405.1122 and 423.2122 describe the evidence that 
may be submitted to and considered by the Council, the process the 
Council follows in issuing subpoenas, the reviewability of Council 
subpoena rulings, and the process for seeking enforcement of subpoenas. 
Current Sec.  405.1122(a)(1) provides that the Council will limit its 
review of the evidence to the evidence contained in the record of the 
proceedings before the ALJ, unless the hearing decision decides a new 
issue that the parties were not afforded an opportunity to address at 
the ALJ level. We are proposing at Sec.  405.1122(a) introductory text 
and (a)(1) to replace each instance of ``ALJ's decision'' with ``ALJ's 
or attorney adjudicator's decision,'' ``before the ALJ'' with ``before 
the ALJ or attorney adjudicator,'' and ``the ALJ level'' with ``the 
OMHA level.'' We believe the standard for review of evidence at the 
Council level would be the same regardless of whether the case was 
decided by an ALJ or attorney adjudicator, as proposed in section II.B 
above, at the OMHA level. We are also proposing corresponding revisions 
to Sec.  423.2122(a) introductory text and (a)(1). Also, to help ensure 
it is clear that the exception for evidence related to new issues 
raised at the OMHA level is not limited to proceedings in which a 
hearing before an ALJ was conducted, we are proposing at Sec. Sec.  
405.1122(a)(1) and Sec.  423.2122(a)(1) to replace ``hearing decision'' 
with ``ALJ's or attorney adjudicator's decision.'' Current Sec.  
405.1122(a)(2) provides that if the Council determines that additional 
evidence is needed to resolve the issues in the case, and the hearing 
record indicates that the previous decision-makers have not attempted 
to obtain the evidence, the Council may remand the case to an ALJ to 
obtain the evidence and issue a new decision. For the reasons described 
above, we are proposing at Sec.  405.1122(a)(2) to replace ``ALJ'' with 
``ALJ or attorney adjudicator'' and ``hearing record'' with 
``administrative record,'' along with corresponding revisions to Sec.  
423.2122(a)(2). Current Sec.  405.1122(b)(1) describes the evidence 
that may be considered by the Council when a case is escalated from the 
ALJ level. For the reasons described above, we are proposing to replace 
``ALJ level'' with ``OMHA level.'' We are not proposing any 
corresponding changes to Sec.  423.2122 because escalation is not 
available for Part D coverage appeals. Finally, we are proposing to 
replace all remaining instances of ``ALJ'' in Sec.  405.1122(b)(1), 
(b)(2), (c)(2), (c)(3) introductory text, (c)(3)(i), and (c)(3)(ii) 
with ``ALJ or attorney adjudicator,'' as we believe the Council's 
authority to consider evidence entered in the record by an attorney 
adjudicator and to remand a case to an attorney adjudicator for 
consideration of new evidence would be the same as the Council's 
current authority to consider evidence entered in the record by an ALJ 
and remand a case to an ALJ. We are not proposing any corresponding 
changes to Sec.  423.2122 because there are no remaining references to 
``ALJ.''
    We are inviting public comments on these proposals. If you choose 
to comment on the proposals in this section, please include the caption 
``What evidence may be submitted to the Council'' at the beginning of 
your comment.
k. Case Remanded by the Council (Sec. Sec.  405.1126 and 423.2126)
    Current Sec. Sec.  405.1126(a) and (b) explain the Council's remand 
authority. We are proposing to replace each instance of ``ALJ'' with 
``ALJ or attorney adjudicator'' to provide that the Council may remand 
a case in which additional evidence is needed or additional action is 
required by the ALJ or attorney adjudicator, as proposed in section 
II.B above. Proposed Sec.  405.1126(b) would also provide that an ALJ 
or attorney adjudicator would take any action that is ordered by the 
Council, and may take any additional action that is not inconsistent 
with the Council's remand order. We believe it is necessary for the 
Council to have the same authority to remand an attorney adjudicator's 
decision to the attorney adjudicator as the Council currently has to 
remand an ALJ's decision to the ALJ, and that the attorney 
adjudicator's actions with respect to the remanded case should be 
subject to the same requirements as an ALJ's actions under the current 
provisions. We are also proposing corresponding revisions to Sec.  
423.2126(a)(1) and (a)(2). Current Sec. Sec.  405.1126(c) and (d) 
describe the procedures that apply when the Council receives a 
recommended decision from the ALJ, including the right of the parties 
to file briefs or other written statements with the Council. Because we 
are proposing in Sec.  405.1126(a) for the Council to have the same 
authority to order an attorney adjudicator to issue a recommended 
decision on remand as the Council currently has to order an ALJ to 
issue a recommended decision, we are also proposing at Sec.  
405.1126(c) and (d) to replace ``ALJ'' with ``ALJ or attorney 
adjudicator'' to provide that the provisions apply to attorney 
adjudicators to the same extent as the provisions apply to ALJs, along 
with corresponding revisions to Sec.  423.2126(a)(3) and (a)(4). 
Finally, current Sec.  405.1126(e)(2) provides that if

[[Page 43851]]

the Council determines more evidence is required after receiving a 
recommended decision, the Council may again remand the case to an ALJ 
for further development and another decision or recommended decision. 
Because we believe the Council should have the same authority to remand 
a case to an attorney adjudicator following receipt of a recommended 
decision, we are proposing at Sec.  405.1126(e)(2) to replace ``ALJ'' 
with ``ALJ or attorney adjudicator,'' along with a corresponding 
revision to Sec.  423.2126(a)(5)(ii), and to insert ``if applicable'' 
after rehearing because a rehearing may not be applicable in every 
circumstance (for example, where an attorney adjudicator issued a 
recommended decision and the Council does not remand with instructions 
to transfer the appeal to an ALJ for a hearing).
    We are inviting public comments on these proposals. If you choose 
to comment on the proposals in this section, please include the caption 
``Case remanded by the Council'' at the beginning of your comment.
l. Action of the Council (Sec. Sec.  405.1128 and 423.2128)
    Current Sec. Sec.  405.1128 and 423.2128 explain the actions the 
Council may take after reviewing the administrative record and any 
additional evidence (subject to the limitations on Council 
consideration of additional evidence). We are proposing at Sec. Sec.  
405.1128(a) and 423.2128(a) to replace ``ALJ'' with ``ALJ or attorney 
adjudicator,'' which would provide that the Council may make a decision 
or remand a case to an ALJ or to an attorney adjudicator (as proposed 
in section II.B above). We believe the Council should have the same 
authority to remand a case to an attorney adjudicator as the Council 
currently has to remand a case to an ALJ. Also, to help ensure there is 
no confusion that Council actions are not limited to proceedings in 
which a hearing before an ALJ was conducted, we are proposing at 
Sec. Sec.  405.1128(b) and 423.2128(b) to replace ``the ALJ hearing 
decision'' with ``the ALJ's or attorney adjudicator's decision.''
    We are inviting public comments on these proposals. If you choose 
to comment on the proposals in this section, please include the caption 
``Action of the Council'' at the beginning of your comment.
m. Request for Escalation to Federal Court (Sec.  405.1132)
    Current Sec.  405.1132 explains the process for an appellant to 
seek escalation of an appeal (other than an appeal of an ALJ dismissal) 
from the Council to Federal district court if the Council does not 
issue a decision or dismissal or remand the case to an ALJ within the 
adjudication time frame specified in Sec.  405.1100, or as extended as 
provided in subpart I. We are proposing at Sec.  405.1132 to replace 
each instance of ``ALJ'' with ``ALJ or attorney adjudicator.'' These 
revisions would provide that the appellant may request that escalation 
of a case, other than a dismissal issued by an ALJ or attorney 
adjudicator, as proposed in section II.B above to Federal district 
court if the Council is unable to issue a decision or dismissal or 
remand the case to an ALJ or attorney adjudicator within an applicable 
adjudication time frame, and that appellants may file an action in 
Federal district court if the Council is not able to issue a decision, 
dismissal, or remand to the ALJ or attorney adjudicator within 5 
calendar days of receipt of the request for escalation or 5 calendar 
days from the end of the applicable adjudication time period. We are 
not proposing any corresponding changes to part 423, subpart U, as 
there is no equivalent provision because there are no escalation rights 
for Part D coverage appeals.
    We are inviting public comments on these proposals. If you choose 
to comment on the proposals in this section, please include the caption 
``Request for escalation to Federal court'' at the beginning of your 
comment.
n. Judicial Review (Sec. Sec.  405.1136, 423.1976, and 423.2136)
    Current Sec. Sec.  405.1136, 423.1976, and 423.2136 set forth the 
right to file a request for judicial review in Federal district court 
of a Council decision (or of an ALJ's decision if the Council declines 
review as provided in Sec.  423.1976(a)(1)). Current Sec.  405.1136 
also provides that judicial review in Federal district court may be 
requested if the Council is unable to issue a decision, dismissal, or 
remand within the applicable time frame following an appellant's 
request for escalation. In addition, current Sec. Sec.  405.1136 and 
423.2136 specify the requirements and procedures for filing a request 
for judicial review, the Federal district court in which such actions 
must be filed, and describe the standard of review. We are proposing at 
Sec. Sec.  405.1136, 423.1976, and 423.2136 to replace each instance of 
``ALJ'' with ``ALJ or attorney adjudicator,'' and ``ALJ's'' with 
``ALJ's or attorney adjudicator's'' to help ensure that there is no 
confusion that appellants may file a request for judicial review in 
Federal district court of actions made by an attorney adjudicator, as 
proposed in section II.B above (or by the Council following an action 
by an attorney adjudicator), to the same extent that judicial review is 
available for ALJ actions (or Council actions following an action by an 
ALJ).
    We are inviting public comments on these proposals. If you choose 
to comment on the proposals in this section, please include the caption 
``Judicial review'' at the beginning of your comment.
o. Case Remanded by a Federal Court (Sec. Sec.  405.1138 and 423.2138)
    Current Sec. Sec.  405.1138 and 423.2138 set forth the actions the 
Council may take when a Federal district court remands a case to the 
Secretary for further consideration. We are proposing at Sec. Sec.  
405.1138 and 423.2138, and 405.1140 and 423.2140 to replace ``ALJ'' 
with ``ALJ or attorney adjudicator'' to provide that when a case is 
remanded by a Federal district court for further consideration by the 
Secretary, the Council may remand the case to an ALJ or attorney 
adjudicator (as proposed in section II.B above), to issue a decision, 
take other action, or return the case to the Council with a recommended 
decision.
    We are inviting public comments on these proposals. If you choose 
to comment on the proposals in this section, please include the caption 
``Case remanded by a Federal court'' at the beginning of your comment.
p. Council Review of ALJ Decision in a Case Remanded by a Federal 
District Court (Sec. Sec.  405.1140 and 423.2140)
    Current Sec. Sec.  405.1140 and 423.2140 set forth the procedures 
that apply when a case is remanded to the Secretary for further 
consideration, and the Council subsequently remands the case to an ALJ, 
including the procedures for the Council to assume jurisdiction 
following the decision of the ALJ on its own initiative or upon receipt 
of written exceptions from a party or the enrollee. We are proposing to 
replace each instance of ``ALJ'' throughout Sec. Sec.  405.1140 and 
423.2140 with ``ALJ or attorney adjudicator'' and to replace the 
reference to ``ALJ's'' at Sec. Sec.  405.1140(d) and 423.2140(d) with 
``ALJ's or attorney adjudicator's.'' These revisions would provide that 
the Council may remand these cases to the ALJ or attorney adjudicator, 
as proposed in section II.B above, following remand from a Federal 
district court, and that the decision of the ALJ or attorney 
adjudicator becomes the final decision of the Secretary after remand 
unless the Council assumes

[[Page 43852]]

jurisdiction. These revisions would further apply the rules set forth 
in this section to cases reviewed by an attorney adjudicator as well as 
an ALJ. As described above in relation to the Council's general remand 
authority under Sec. Sec.  405.1126 and 423.2126, we believe it is 
necessary for the Council to have the same authority to remand an 
attorney adjudicator's decision to the attorney adjudicator as the 
Council currently has to remand an ALJ's decision to the ALJ, and that 
would include cases that are remanded by a Federal district court to 
the Secretary for further consideration.
    We are inviting public comments on these proposals. If you choose 
to comment on the proposals in this section, please include the caption 
``Council review of ALJ decision in a case remanded by a Federal 
district court'' at the beginning of your comment.

B. Part 405, Subpart J Expedited Reconsiderations (Sec.  405.1204)

    In accordance with section 1869(b)(1)(F) of the Act, current Sec.  
405.1204 provides for expedited QIC reconsiderations of certain QIO 
determinations related to provider-initiated terminations of Medicare-
covered services and beneficiary discharges from a provider's facility. 
Current Sec.  405.1204(c)(4)(iii) explains that the QIC's initial 
notification may be done by telephone followed by a written notice that 
includes information about the beneficiary's right to appeal the QIC's 
reconsideration decision to an ALJ, and current Sec.  405.1204(c)(5) 
provides that if the QIC does not issue a decision within 72 hours of 
receipt of the request for a reconsideration, the case can be escalated 
to the ``ALJ hearing level.'' For consistency with part 405, subpart I, 
and to explain the rules that apply to an ALJ hearing, we are proposing 
at Sec.  405.1204(c)(4)(iii) and (c)(5) to amend these references to 
convey that a QIC reconsideration can be appealed to, or a request for 
a QIC reconsideration can be escalated to OMHA for an ALJ hearing in 
accordance with part 405, subpart I. We believe these revisions would 
explain where a request for an ALJ hearing is directed from a subpart J 
proceeding, and the rules that would be applied to the request for an 
ALJ hearing following the QIC's reconsideration or escalation of the 
request for a QIC reconsideration.
    Current Sec.  405.1204(c)(5) states that the beneficiary has a 
right to escalate a request for a QIC reconsideration if the amount 
remaining in controversy after the QIO determination is $100 or more. 
However, this is inconsistent with the amount in controversy specified 
in section 1869(b)(1)(E) of the Act. We are proposing to revise Sec.  
405.1204(c)(5) to provide that there is a right to escalate a request 
for a QIC reconsideration if the amount remaining in controversy after 
the QIO determination meets the requirements for an ALJ hearing under 
Sec.  405.1006. We believe that this is more consistent with section 
1869(b)(1)(E) of the Act, which provides that a hearing by the 
Secretary shall not be available to an individual if the amount in 
controversy is less than $100, as adjusted annually after 2004, which 
is implemented in Sec.  405.1006, and would bring consistency to the 
amounts in controversy required for an escalation under subpart J and 
subpart I.
    We are inviting public comments on these proposals. If you choose 
to comment on the proposals in this section, please include the caption 
``Part 405, subpart J expedited reconsiderations'' at the beginning of 
your comment.

C. Part 422, Subpart M

1. General Provisions (Sec.  422.562)
    Current Sec.  422.562(c)(1)(ii) states that if an enrollee receives 
immediate QIO review of a determination of non-coverage of inpatient 
hospital care, the QIO review decision is subject only to the appeal 
procedures set forth in parts 476 and 478 of title 42, chapter IV. 
However, we believe this provision is an outdated reference that has 
been superseded by current Sec.  422.622, which provides for requesting 
immediate QIO review of the decision to discharge an enrollee from an 
inpatient hospital setting and appeals of that review as described 
under part 422, subpart M. The regulatory provisions at Sec.  422.622 
describe the processes for QIO review of the decision to discharge an 
MA enrollee from the inpatient hospital setting. Section 422.622 also 
explains the availability of other appeals processes if the enrollee 
does not meet the deadline for an immediate QIO review of the discharge 
decision. These part 422, subpart M provisions govern the review 
processes for MA enrollees disputing discharge from an inpatient 
hospital setting. As noted above, we believe the references to the 
procedures in parts 476 and 478 at Sec.  422.562(c)(1)(ii) are 
obsolete. Therefore, we are proposing to delete Sec.  422.562(c)(1) to 
remove the outdated reference in current Sec.  422.562(c)(1)(ii) and 
consolidate current (c)(1) and (c)(1)(i) into proposed (c)(1). We also 
note that changes to Sec.  422.562(d) are proposed and discussed in 
section II.C, above.
    We are inviting public comments on these proposals. If you choose 
to comment on the proposals in this section, please include the caption 
``General provisions'' at the beginning of your comment.
2. Notice of Reconsidered Determination by the Independent Entity 
(Sec.  422.594)
    Current Sec.  422.594(b)(2) requires the notice of the 
reconsideration determination by an IRE to inform the parties of their 
right to an ALJ hearing if the amount in controversy is $100 or more, 
if the determination is adverse (does not completely reverse the MAO's 
adverse organization determination). We are proposing at Sec.  
422.594(b)(2) to amend this requirement so that the notice informs the 
parties of their right to an ALJ hearing if the amount in controversy 
meets the requirements of Sec.  422.600, which in turn refers to the 
part 405 computation of the amount in controversy. We believe this 
would increase accuracy in conveying when a party has a right to an ALJ 
hearing, and would be more consistent with section 1852(g)(5) of the 
Act, which provides that a hearing by the Secretary shall not be 
available to an individual if the amount in controversy is less than 
$100, as adjusted annually in accordance with section 
1869(b)(1)(E)(iii) of the Act, which is implemented in part 405 at 
Sec.  405.1006. We discuss proposed changes to Sec.  405.1006 in 
section III.A.3.d above.
    We are inviting public comments on these proposals. If you choose 
to comment on the proposals in this section, please include the caption 
``Notice of reconsidered determination by the independent entity'' at 
the beginning of your comment.
3. Request for an ALJ Hearing (Sec.  422.602)
    Current Sec.  422.602(b) provides that a party must file a request 
for an ALJ hearing within 60 days of the date of the notice of the 
IRE's reconsidered determination. However, in similar appeals brought 
under Medicare Part A and Part B at Sec.  405.1002, and Part D at Sec.  
423.2002, a request for an ALJ hearing must be filed within 60 calendar 
days of receipt of a notice of reconsideration. We are proposing at 
Sec.  422.602(b)(1) to align the part 422 time frame for filing a 
request for an ALJ hearing with provisions for similar appeals under 
Medicare Part A and Part B, and Part D. As proposed, a request for an 
ALJ hearing would be required to be filed within 60 calendar days of 
receiving the notice of a reconsidered determination, except when the 
time frame is extended by an ALJ or, as proposed, attorney

[[Page 43853]]

adjudicator, as provided in part 405. To provide consistency for when a 
notice of a reconsidered determination is presumed to have been 
received, we are proposing at Sec.  422.602(b)(2) that the date of 
receipt of the reconsideration is presumed to be 5 calendar days after 
the date of the notice of the reconsidered determination, unless there 
is evidence to the contrary, which is the same presumption that is 
applied to similar appeals under Medicare Part A and Part B at Sec.  
405.1002, and Part D at Sec.  423.2002.
    We are inviting public comments on these proposals. If you choose 
to comment on the proposals in this section, please include the caption 
``Request for an ALJ hearing'' at the beginning of your comment.
4. Medicare Appeals Council (Council) Review (Sec.  422.608)
    Current Sec.  422.608 provides that any party to the hearing, 
including the MAO, who is dissatisfied with the ALJ hearing decision 
may request that the Council review the ALJ's decision or dismissal. We 
believe that the reference to a hearing, hearing decision, then 
decision or dismissal may cause confusion regarding a party's right to 
request Council review. We are proposing at Sec.  422.608 that any 
party to the ALJ's or, as proposed in section II.B above, attorney 
adjudicator's decision or dismissal, including the MAO, who is 
dissatisfied with the decision or dismissal, may request that the 
Council review the decision or dismissal. We believe this would resolve 
any potential confusion regarding a party's right to request Council 
review of a decision when a hearing was not conducted, and a dismissal 
of a request for hearing, and provide that the section applies to 
decisions and dismissals issued by an attorney adjudicator, as proposed 
in section II.B. Therefore, proposed Sec.  422.608 would provide that a 
request for Council review may be filed by a party if he or she is 
dissatisfied with an ALJ's or attorney adjudicator's decision or 
dismissal.
    We are inviting public comments on these proposals. If you choose 
to comment on the proposals in this section, please include the caption 
``Medicare Appeals Council (Council) review'' at the beginning of your 
comment. We discuss other proposed changes to Sec.  422.608 in section 
II.D above.
5. Judicial Review (Sec.  422.612)
    Current Sec.  422.612 provides the circumstances under which a 
party may request judicial review of an ALJ or Council decision, and 
directs appellants to the procedures in part 405 for filing a request 
for judicial review. We are proposing at Sec.  422.612(a) to replace 
each instance of ``ALJ's'' with ``ALJ's or attorney adjudicator's''. 
Thus, as provided in Sec.  422.612(a), appellants would be able to file 
a request for judicial review in Federal district court of actions made 
by an attorney adjudicator, as proposed in section II.B above (or by 
the Council following an action by an attorney adjudicator), to the 
same extent that judicial review is available under Sec.  412.622(a) 
for ALJ actions (or Council actions following an action by an ALJ).
    We are inviting public comments on these proposals. If you choose 
to comment on the proposals in this section, please include the caption 
``Judicial review'' at the beginning of your comment.
6. Reopening and Revising Determinations and Decisions (Sec.  422.616)
    Current Sec.  422.616(a) provides that the determination or 
decision of an MA organization, independent entity, ALJ, or the Council 
that is otherwise final and binding may be reopened and revised by the 
entity that made the determination or decision, subject to the rules in 
part 405. We are proposing at Sec.  422.616(a) to replace ``ALJ'' with 
``ALJ or attorney adjudicator.'' As described in section III.A.2.l 
above with respect to Sec. Sec.  405.980, 405.982, 405.984, 423.1980, 
423.1982, and 423.1984, we believe it is necessary for an attorney 
adjudicator to have the authority to reopen the attorney adjudicator's 
decision on the same bases as an ALJ may reopen the ALJ's decision 
under the current rules, and the action should be subject to the same 
limitations and requirements, and have the same effects as an ALJ's 
action under these provisions.
    We are inviting public comments on these proposals. If you choose 
to comment on the proposals in this section, please include the caption 
``Reopening and revising determinations and decisions'' at the 
beginning of your comment.
7. How an MA Organization Must Effectuate Standard Reconsideration 
Determinations and Decisions, and Expedited Reconsidered Determinations 
(Sec. Sec.  422.618 and 422.619)
    Current Sec.  422.618(c)(1) and (c)(2) provide instructions for 
effectuation of decisions issued by an ALJ, or at a higher level of 
appeal, that reverse an IRE's decision on a standard reconsidered 
determination or decision. We are proposing to replace ``ALJ'' with 
``ALJ or attorney adjudicator'' at Sec.  422.618(c)(1) and to make 
corresponding changes to Sec.  422.619(c)(1) for decisions that reverse 
an IRE's decision on an expedited reconsidered determination or 
decision. We believe the process for effectuating the decision of an 
attorney adjudicator, as proposed in section II.B above, should be the 
same as the process for effectuating the decision of an ALJ.
    We are inviting public comments on these proposals. If you choose 
to comment on the proposals in this section, please include the caption 
``How an MA organization must effectuate standard reconsideration 
determinations and decisions, and expedited reconsidered 
determinations'' at the beginning of your comment.
8. Requesting Immediate QIO Review of the Decision to Discharge From 
the Inpatient Hospital and Fast-Track Appeals of Service Terminations 
to Independent Review Entities (IREs) (Sec. Sec.  422.622 and 422.626).
    In accordance with section 1852(g)(3) and (g)(4) of the Act, 
current Sec. Sec.  422.622 and 422.626 provide for reviews of QIO 
determinations and expedited IRE reconsiderations of certain QIO 
determinations related to terminations of covered provider services 
furnished by home health agencies (HHAs), skilled nursing facilities 
(SNFs), and comprehensive outpatient rehabilitation facilities (CORFs) 
to a Medicare Advantage enrollee, and Medicare Advantage enrollee 
discharges from an inpatient hospital. Current Sec.  422.622(g) 
provides that if an enrollee is still an inpatient in the hospital 
after a QIO determination reviewing a provider discharge from a 
hospital, the enrollee may request an IRE reconsideration of the QIO 
determination in accordance with Sec.  422.626(g); and if an enrollee 
is no longer an inpatient in the hospital, the enrollee may appeal the 
QIO determination to an ALJ. Current Sec.  422.626(g)(3) provides that 
if the IRE reaffirms its decision to terminate covered provider 
services furnished by a HHA, SNF, or CORF in whole or in part, the 
enrollee may appeal the IRE's reconsidered determination to an ALJ. We 
are proposing at Sec. Sec.  422.622(g)(2) and 422.626(g)(3) to amend 
these references to provide that the appeal is made to OMHA for an ALJ 
hearing. We believe these revisions would clarify where a request for 
an ALJ hearing is directed.
    We are inviting public comments on these proposals. If you choose 
to comment on the proposals in this section, please include the caption 
``Requesting immediate QIO review of the decision to discharge from the

[[Page 43854]]

inpatient hospital and fast-track appeals of service terminations to 
independent review entities (IREs)'' at the beginning of your comment.

D. Part 478, Subpart B

1. Applicability and Beneficiary's Right to a Hearing (Sec. Sec.  
478.14 and 478.40)
    Current Sec.  478.14(c)(2) explains that for the purposes of part 
478 reconsideration and appeals, limitation of liability determinations 
on excluded coverage of certain services are made under section 1879 of 
the Act, and initial determinations under section 1879 of the Act and 
further appeals are governed by the reconsideration and appeal 
procedures in part 405, subpart G for determinations under Medicare 
Part A, and part 405, subpart H for determinations under Medicare Part 
B. In addition, current Sec.  478.40 states that an ALJ hearing may be 
obtained from the SSA Office of Hearings and Appeals, and the 
provisions of subpart G of 42 CFR part 405 apply unless they are 
inconsistent with the specific provisions of subpart B of 42 CFR part 
478. These references are outdated. Since Sec. Sec.  478.14 and 478.40 
were last updated in 1999, section 931 of the MMA transferred 
responsibility for the ALJ hearing function from SSA to HHS, and HHS 
established OMHA in 2005, to administer the ALJ hearing function, 
including ALJ hearings conducted under titles XI and XVIII of the 
Social Security Act (see 70 FR 36386). In addition, BIPA and the MMA 
established new appeal procedures that were implemented in 2005, at 42 
CFR part 405, subpart I (70 FR 11420), and the portions of subparts G 
and H that previously applied to part 478, subpart B appeals were 
removed in 2012 (77 FR 29002). Proposed Sec. Sec.  478.14 and 478.40 
would replace the current outdated references to part 405, subparts G 
and H, with references to part 405, subpart I. Proposed Sec.  478.40 
would also update the reference to the entity with responsibility for 
the ALJ hearing function by replacing the SSA Office of Hearings and 
Appeals with OMHA.
    We are inviting public comments on these proposals. If you choose 
to comment on the proposals in this section, please include the caption 
``Applicability and beneficiary's right to a hearing'' at the beginning 
of your comment.
2. Submitting a Request for a Hearing (Sec.  478.42)
    Similar to current Sec.  478.40, as discussed above, current Sec.  
478.42(a) has outdated references to SSA offices that are no longer 
involved in the Medicare claim appeals process. In addition, current 
Sec.  478.42(a) permits beneficiaries to file requests for an ALJ 
hearing with other entities, which could cause significant delays in 
obtaining a hearing before an OMHA ALJ. Proposed Sec.  478.42(a) would 
direct beneficiaries to file a request for an ALJ hearing with the OMHA 
office identified in the QIO's notice of reconsidered determination. 
This revision would be clearer for beneficiaries, who are provided with 
appeal instructions by the QIOs, and reduce delays in obtaining a 
hearing by an OMHA ALJ.
    Current Sec.  478.42(b) requires that a request for hearing is 
filed within 60 calendar days of receipt of the notice of the QIO 
reconsidered determination and the date of receipt is assumed to be 5 
days after the date on the notice unless there is a reasonable showing 
to the contrary. Current Sec.  478.42(b) also provides that a request 
is considered filed on the date it is postmarked. To align part 478, 
subpart B with procedures for requesting an ALJ hearing under part 405, 
subpart I; part 422, subpart M; and part 423, subpart U, proposed Sec.  
478.42(b) would provide that the request for hearing must be filed 
within 60 ``calendar'' days of receiving notice of the QIO reconsidered 
determination and that the notice is presumed to be received 5 
``calendar'' days after the date of the notice. In addition, to further 
align the part 478, subpart B procedures for requesting an ALJ hearing 
with the other parts, proposed Sec.  478.42(c) would amend the standard 
to demonstrate that notice of QIO reconsidered determination was not 
received within 5 calendar days by requiring ``evidence'' rather than 
the current ``reasonable showing,'' and would also revise when a 
request is considered filed, from the date it is postmarked to the date 
it is received by OMHA. These changes would create parity with requests 
for hearing filed by beneficiaries and enrollees for similar services 
but under other parts of title 42, chapter IV.
    We are inviting public comments on these proposals. If you choose 
to comment on the proposals in this section, please include the caption 
``Submitting a request for a hearing'' at the beginning of your 
comment.
3. Determining the Amount in Controversy (Sec.  478.44)
    Current Sec.  478.44(a) explains how the amount in controversy for 
an ALJ hearing is determined in part 478, subpart B hearings. Current 
Sec.  478.44(a) has outdated references to Sec. Sec.  405.740 and 
405.817 from part 405, subparts G and H respectively, for calculating 
the amount in controversy for an individual appellant or multiple 
appellants. In 2012, subpart G was removed and subpart H was 
significantly revised and no longer applies to Medicare claim appeals 
(77 FR 29002). To update these reference to the current part 405 rules, 
proposed Sec.  478.44(a) would replace the outdated cross-references 
for calculating the amount in controversy with Sec.  405.1006(d) and 
(e), which describe the calculation for determining the amount in 
controversy and the standards for aggregating claims by an individual 
appellant or multiple appellants. We discuss proposed changes to Sec.  
405.1006 in section III.A.3.d above.
    Current Sec.  478.44(b) and (c) explain that if an ALJ determines 
the amount in controversy is less than $200, the ALJ, without holding a 
hearing, notifies the parties to the hearing, and if a request for 
hearing is dismissed because the amount in controversy is not met, a 
notice will be sent to the parties to the hearing. However, when a 
request for hearing is dismissed because the amount in controversy is 
not met, no hearing is conducted and the parties are parties to the 
proceedings regardless of whether a hearing was conducted. To prevent 
potential confusion, proposed Sec.  478.44(b) and (c) would replace 
``parties to the hearing'' with ``parties'' so it is understood that 
they are parties regardless of whether a hearing is conducted. Because 
an attorney adjudicator would have to determine whether appeals 
assigned to him or her, as proposed in section II.B above, meet the 
amount in controversy requirement, we also propose at Sec.  478.44(a) 
and (b) that an attorney adjudicator may determine that the amount in 
controversy, and may determine the amount in controversy is less than 
$200 and notify the parties to submit additional evidence to prove that 
the amount in controversy is at least $200. However, because we are not 
proposing that an attorney adjudicator can dismiss a request for an ALJ 
hearing because the amount in controversy is not met, proposed Sec.  
478.44(c) provides that an ALJ would dismiss a request if at the end of 
the 15-day period to submit additional evidence to prove that the 
amount in controversy is at least $200, the ALJ determines that the 
amount in controversy is less than $200.
    We are inviting public comments on these proposals. If you choose 
to comment on the proposals in this section, please include the caption 
``Determining the amount in controversy'' at the beginning of your 
comment.

[[Page 43855]]

4. Medicare Appeals Council and Judicial Review (Sec.  478.46)
    Current Sec.  478.46(a) states that the Council will review an 
ALJ's hearing decision or dismissal under the same circumstances as 
those set forth at 20 CFR 404.970, which is now an outdated reference 
to SSA Appeals Council procedures for Council review. We are proposing 
at Sec.  478.46(a) to replace the outdated reference to 20 CFR 404.970 
with references to current Sec. Sec.  405.1102 (``Request for Council 
review when ALJ or attorney adjudicator issued a decision or 
dismissal'') and 405.1110 (``Council reviews on its own motion''). In 
addition, we are proposing in Sec.  478.46(a) and (b) to replace 
``hearing decision'' with ``decision,'' and ``ALJ'' with ``ALJ or 
attorney adjudicator'' because hearings are not always conducted and a 
decision can generally be appealed regardless of whether a hearing was 
conducted, and attorney adjudicators may issue decisions or dismissals 
for which Council review may be requested, as proposed in section II.B 
above.
    We are inviting public comments on these proposals. If you choose 
to comment on the proposals in this section, please include the caption 
``Medicare Appeals Council and judicial review'' at the beginning of 
your comment.
5. Reopening and Revision of a Reconsidered Determination or a Decision 
(Sec.  478.48)
    The title of current Sec.  478.48 references reopenings and 
revisions of reconsidered determinations and hearing decisions, and 
current Sec.  478.48 has an outdated reference to subpart G of 42 CFR 
part 405 for the procedures for reopening a decision by an ALJ or the 
Departmental Appeals Board.
    We are proposing to revise the title of Sec.  478.48 to replace 
``hearing decision'' with ``decision,'' and in proposed paragraphs (b) 
and (c) to replace ``ALJ'' with ``ALJ or attorney adjudicator'' so the 
provision is understood to apply to decisions by ALJs, regardless of 
whether a hearing was conducted, or, as proposed in section II.B above, 
attorney adjudicators, as well as review decisions, which are conducted 
by the Medicare Appeals Council at the Departmental Appeals Board. We 
also propose at Sec.  478.48(b) to replace the outdated reference to 
Sec.  405.750(b), which was part of the now removed part 405, subpart G 
(77 FR 29016 through 29018), with Sec.  405.980, which is the current 
part 405, subpart I reopening provision.
    We are inviting public comments on these proposals. If you choose 
to comment on the proposals in this section, please include the caption 
``Reopening and revision of a reconsidered determination or a 
decision'' at the beginning of your comment.

IV. Collection of Information Requirements

    Under the Paperwork Reduction Act of 1995 (PRA), we are required to 
provide 60-day notice in the Federal Register and solicit public 
comment before a collection of information requirement is submitted to 
the Office of Management and Budget (OMB) for review and approval. In 
order to fairly evaluate whether an information collection should be 
approved by OMB, section 3506(c)(2)(A) of the PRA requires that we 
solicit comment on the following issues:
     The need for the information collection and its usefulness 
in carrying out the proper functions of our agency.
     The accuracy of our estimate of the information collection 
burden.
     The quality, utility, and clarity of the information to be 
collected.
     Recommendations to minimize the information collection 
burden on the affected public, including automated collection 
techniques.
    Therefore, we are soliciting public comments on each of these 
issues for the information collection requirements discussed below.
    The PRA exempts most of the information collection activities 
referenced in this proposed rule. In particular, the implementing 
regulations of the PRA at 5 CFR 1320.4 exclude collection activities 
during the conduct of a civil action to which the United States or any 
official or agency thereof is a party. Civil actions include 
administrative actions such as redeterminations, reconsiderations, and/
or appeals. Specifically, these actions are taken after the initial 
determination or a denial of payment, or MAO organization determination 
or Part D plan sponsor coverage determination. However, one requirement 
contained in this proposed rule is subject to the PRA because the 
burden is imposed prior to an administrative action or denial of 
payment. This requirement is discussed below.
    In summary, we are proposing at Sec.  405.910 that when a provider 
or supplier is the party appointing a representative, the appointment 
of representation would include the Medicare National Provider 
Identifier (NPI) of the provider or supplier that furnished the item of 
service. Although this is a new regulatory requirement, the current 
Medicare Claims Processing Manual already states that the NPI should be 
included when a provider or supplier appoints a representative. The 
standardized form for appointing a representative, Form CMS-1696, 
currently provides a space for the information in question. 
Importantly, this form is currently approved under OMB control number 
0938-0950 and expires June 30, 2018.
    The burden associated with this requirement is the time and effort 
of an individual or entity who is a provider or supplier to prepare an 
appointment of representation containing the NPI. As stated earlier, 
this requirement and the related burden are subject to the PRA; 
however, because we believe that this information is already routinely 
being collected, we estimate there would be no additional burden for 
completing an appointment of representative in accordance with proposed 
405.910.
    If you wish to view the standardized form and the supporting 
documentation, you can download a copy from the CMS Web site at https://www.cms.gov/medicare/cms-forms/cms-forms/cms-forms-list.html.
    We have submitted a copy of this proposed rule to OMB for its 
review of the information collection requirements described above.
    We are inviting public comment on the burden associated with these 
information collection requirements.

V. Response to Comments

    Because of the large number of public comments we normally receive 
on Federal Register documents, we are not able to acknowledge or 
respond to them individually. We will consider all comments we receive 
by the date and time specified in the DATES section of this proposed 
rule, and, when we proceed with a subsequent document, we will respond 
to the comments in the preamble to that document.

VI. Regulatory Impact Statement

    We have examined the impacts of this proposed rule as required by 
Executive Order 12866 on Regulatory Planning and Review (September 30, 
1993), Executive Order 13563 on Improving Regulation and Regulatory 
Review (January 18, 2011), the Regulatory Flexibility Act (RFA) 
(September 19, 1980, Pub. L. 96-354), section 1102(b) of the Social 
Security Act, section 202 of the Unfunded Mandates Reform Act of 1995 
(March 22, 1995; Pub. L. 104-4), Executive Order 13132 on Federalism 
(August 4, 1999) and the Congressional Review Act (5 U.S.C. 804(2)).

[[Page 43856]]

    Executive Orders 12866 and 13563 direct agencies to assess all 
costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity). A 
regulatory impact analysis (RIA) must be prepared for major rules with 
economically significant effects ($100 million or more in any 1 year). 
We have determined that the effect of this proposed rule does not reach 
this economic threshold and thus is not considered a major rule. As 
detailed above, this proposed rule would only make minimal changes to 
the existing Medicare appeals procedures for claims for benefits under 
or entitlement to the original Medicare programs, and coverage of 
items, services, and drugs under the Medicare Advantage and voluntary 
Medicare prescription drug programs. Thus, this proposed rule would 
have negligible financial impact on beneficiaries and enrollees, 
providers or suppliers, Medicare contractors, MAOs, and Part D plan 
sponsors, but would derive benefits to the program and appellants.
    HHS recognizes that the current appeals backlog is a matter of 
great significance, and it has made it a priority to adopt measures 
that are designed to reduce the backlog and improve the overall 
Medicare appeals process moving forward. To that end, HHS has initiated 
a series of measures, including this proposed regulation, that are 
aimed at both reducing the backlog and creating a more efficient 
Medicare appeals system.
    We believe the changes proposed in this regulation will help 
address the Medicare appeals backlog and create efficiencies at the ALJ 
level of appeal by allowing OMHA to reassign a portion of workload to 
non-ALJ adjudicators, reduce appeals of low-value claims, and reduce 
procedural ambiguities that result in unproductive efforts at OMHA and 
unnecessary appeals to the Medicare Appeals Council. In addition, the 
other proposed changes, including precedential decisions and generally 
limiting CMS and CMS contractor participation or party status at the 
OMHA level unless the ALJ determines participation by additional 
entities is necessary for a full examination of the matters at issue 
(as provided in proposed Sec. Sec.  405.1010(d) and 405.1012(d)), will 
collectively make the ALJ hearing process more efficient through 
streamlined and standardized procedures and more consistent decisions, 
and reduce appeals to the Medicare Appeals Council.
    In particular, we are able to estimate the impact from two of the 
proposed modifications: proposals to expand the pool of adjudicators 
and the modifications to calculating the amount in controversy (AIC) 
required for an ALJ hearing. Based on FY 2015, and an assumption that 
future years are similar to FY 2015, we estimate that the proposals to 
expand the pool of adjudicators at OMHA could redirect approximately 
23,650 appeals per year to attorney adjudicators to process these 
appeals at a lower cost than would be required if only ALJs were used 
to address the same workload. If the number of requests for hearing, 
waivers of oral hearing, requests for review of a contractor dismissal, 
or appellant withdrawals of requests for hearing vary from FY 2015 in 
future years then the number of appeals potentially addressed by 
attorney adjudicators would likely also vary. Additionally, based on FY 
2015 requests for an ALJ hearing, we estimate that revising the 
calculation methodology for the AIC required for an ALJ hearing could 
remove appeals related to over 2,600 Part B low-value claims per year 
from the ALJ hearing process, after accounting for the likelihood of 
appellants aggregating claims to meet the AIC. We also note that 
appeals filed by Medicare beneficiaries, and Medicare Advantage and 
Part D prescription drug plan enrollees would be minimally impacted 
because they often appeal claim or coverage denials for which they are 
financially responsible, and for which we would use the existing AIC 
calculation methodology. We note that this analysis is limited by the 
use of only one fiscal year's worth of data, and that there is 
uncertainty in this estimate as the number of appeals that would fall 
under the revised AIC calculation may vary from year to year.
    The Regulatory Flexibility Act (5 U.S.C. 601 et seq.) (RFA) 
requires agencies to prepare an initial regulatory flexibility analysis 
to describe the impact of the proposed rule on small entities, unless 
the head of the agency can certify that the rule would not have a 
significant economic impact on a substantial number of small entities. 
The RFA generally defines a ``small entity'' as: (1) A proprietary firm 
meeting the size standards of the Small Business Administration (SBA); 
(2) a not-for-profit organization that is not dominant in its field; or 
(3) a small government jurisdiction with a population of less than 
50,000. States and individuals are not included in the definition of 
``small entity.'' HHS uses as its measure of significant economic 
impact on a substantial number of small entities a change in revenues 
of more than 3 to 5 percent.
    For purposes of the RFA, most providers and suppliers are small 
entities, either by nonprofit status or by having revenues of less than 
$7.5 million to $38.5 million in any one year. In addition, a number of 
MAOs and Part D plan sponsors (insurers) are small entities due to 
their nonprofit status; however, few if any meet the SBA size standard 
for a small insurance firm by having revenues of $38.5 million or less 
in any one year. Individuals and States are not included in the 
definition of a small entity. We have determined and we certify that 
this proposed rule would not have a significant economic impact on a 
substantial number of small entities because as noted above, this 
proposed rule if finalized would make only minimal changes to the 
existing appeals procedures. Therefore, we are not preparing an 
analysis for the RFA.
    In addition, section 1102(b) of the Act requires us to prepare a 
regulatory impact analysis (RIA) if a rule may have a significant 
impact on the operations of a substantial number of small rural 
hospitals. For proposed rules, this analysis must conform to the 
provisions of section 603 of the RFA. For purposes of section 1102(b) 
of the Act, we define a small rural hospital as a hospital that is 
located outside of a Metropolitan Statistical Area for Medicare payment 
regulations and has fewer than 100 beds. We have determined that this 
proposed rule would not have a significant effect on the operations of 
a substantial number of small rural hospitals. As noted above, this 
proposed rule if finalized would make only minimal changes to the 
existing appeals procedures and thus, would not have a significant 
impact on small entities or the operations of a substantial number of 
small rural hospitals. Therefore, we are not preparing an analysis for 
section 1102(b) of the Act.
    Section 202 of the Unfunded Mandates Reform Act of 1995 also 
requires that agencies assess anticipated costs and benefits before 
issuing any rule that would include any Federal mandate that may result 
in expenditure in any one year by State, local, or Tribal governments, 
in the aggregate, or by the private sector, of $100 million in 1995 
dollars, updated annually for inflation. Currently, that threshold is 
approximately $146 million. This proposed rule would not impose 
spending costs on State, local, or tribal governments in the aggregate, 
or on the private sector in the amount of $146 million in any one year, 
because as

[[Page 43857]]

noted above, this proposed rule if finalized would make only minimal 
changes to the existing appeals procedures.

VII. Federal Analysis

    Executive Order 13132 on Federalism establishes certain 
requirements that an agency must meet when it publishes a proposed rule 
(and subsequent final rule) that imposes substantial direct requirement 
costs on State and local governments, preempts State law, or otherwise 
has Federalism implications. This proposed rule would not impose 
substantial direct requirement costs on State or local governments, 
preempt State law, or otherwise implicate federalism.
    In accordance with the provisions of Executive Order 12866, this 
regulation was reviewed by the Office of Management and Budget.

List of Subjects

42 CFR Part 401

    Claims, Freedom of information, Health facilities, Medicare, 
Privacy.

42 CFR Part 405

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

42 CFR Part 422

    Administrative practice and procedure, Health facilities, Health 
maintenance organizations (HMO), Medicare, Penalties, Privacy, and 
Reporting and recordkeeping requirements.

42 CFR Part 423

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

42 CFR Part 478

    Administrative practice and procedure, Health care, Health 
professions, Peer Review Organizations (PRO), Reporting and 
recordkeeping requirements.

    For the reasons set forth in the preamble, the Department of Health 
and Human Services proposes to amend 42 CFR chapter IV as set forth 
below:

PART 401--GENERAL ADMINISTRATIVE REQUIREMENTS

0
1. The authority citation for part 401 continues to read as follows:

    Authority:  Secs. 1102, 1871, and 1874(e) of the Social Security 
Act (42 U.S.C. 1302, 1395hh, and 1395w-5).

0
2. Section 401.109 is added to read as follows:


Sec.  401.109  Precedential Final Decisions of the Secretary.

    (a) The Chair of the Department of Health and Human Services 
Departmental Appeals Board may designate a final decision of the 
Secretary issued by the Medicare Appeals Council in accordance with 
part 405, subpart I; part 422, subpart M; part 423, subpart U; or part 
478, subpart B, of this chapter as precedential.
    (b) Precedential decisions are made available to the public, with 
personally identifiable information of the beneficiary removed, and 
have precedential effect from the date they are made available to the 
public. Notice of precedential decisions is published in the Federal 
Register.
    (c) Medicare Appeals Council decisions designated in accordance 
with paragraph (a) of this section have precedential effect and are 
binding on all CMS components, on all HHS components that adjudicate 
matters under the jurisdiction of CMS, and on the Social Security 
Administration to the extent that components of the Social Security 
Administration adjudicate matters under the jurisdiction of CMS.
    (d) Precedential effect, as used in this section, means that the 
Medicare Appeals Council's--
    (1) Legal analysis and interpretation of a Medicare authority or 
provision is binding and must be followed in future determinations and 
appeals in which the same authority or provision applies and is still 
in effect; and
    (2) Factual findings are binding and must be applied to future 
determinations and appeals involving the same parties if the relevant 
facts are the same and evidence is presented that the underlying 
factual circumstances have not changed since the issuance of the 
precedential final decision.

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

0
3. The authority citation for part 405 continues to read as follows:

    Authority: Secs. 205(a), 1102, 1861, 1862(a), 1869, 1871, 1874, 
1881, and 1886(k) of the Social Security Act (42 U.S.C. 405(a), 
1302, 1395x, 1395y(a), 1395ff, 1395hh, 1395kk, 1395rr and 
1395ww(k)), and sec. 353 of the Public Health Service Act (42 U.S.C. 
263a).

0
4. Section 405.902 is amended by adding the definitions of ``Attorney 
Adjudicator'', ``Council'', and ``OMHA'' in alphabetical order and 
removing the definition of ``MAC'' to read as follows:


Sec.  405.902  Definitions.

* * * * *
    Attorney Adjudicator means a licensed attorney employed by OMHA 
with knowledge of Medicare coverage and payment laws and guidance, and 
authorized to take the actions provided for in this subpart on requests 
for ALJ hearing and requests for reviews of QIC dismissals.
* * * * *
    Council stands for the Medicare Appeals Council within the 
Departmental Appeals Board of the U.S. Department of Health and Human 
Services.
* * * * *
    OMHA stands for the Office of Medicare Hearings and Appeals within 
the U.S. Department of Health and Human Services, which administers the 
ALJ hearing process in accordance with section 1869(b)(1) of the Act.
* * * * *
0
5. Section 405.904 is amended by revising paragraphs (a)(1) and (2) to 
read as follows:


Sec.  405.904  Medicare initial determinations, redeterminations and 
appeals: General description.

    (a) * * *
    (1) Entitlement appeals. The SSA makes an initial determination on 
an application for Medicare benefits and/or entitlement of an 
individual to receive Medicare benefits. A beneficiary who is 
dissatisfied with the initial determination may request, and SSA will 
perform, a reconsideration in accordance with 20 CFR part 404, subpart 
J if the requirements for obtaining a reconsideration are met. 
Following the reconsideration, the beneficiary may request a hearing 
before an Administrative Law Judge (ALJ) under this subpart (42 CFR 
part 405, subpart I). If the beneficiary obtains a hearing before an 
ALJ and is dissatisfied with the decision of the ALJ, or if the 
beneficiary requests a hearing and no hearing is conducted, and the 
beneficiary is dissatisfied with the decision of an ALJ or an attorney 
adjudicator, he or she may request the Medicare Appeals Council 
(Council) to review the case. Following the action of the Council, the 
beneficiary may be entitled to file suit in Federal district court.

[[Page 43858]]

    (2) Claim appeals. The Medicare contractor makes an initial 
determination when a claim for Medicare benefits under Part A or Part B 
is submitted. A beneficiary who is dissatisfied with the initial 
determination may request that the contractor perform a redetermination 
of the claim if the requirements for obtaining a redetermination are 
met. Following the contractor's redetermination, the beneficiary may 
request, and the Qualified Independent Contractor (QIC) will perform, a 
reconsideration of the claim if the requirements for obtaining a 
reconsideration are met. Following the reconsideration, the beneficiary 
may request a hearing before an ALJ. If the beneficiary obtains a 
hearing before the ALJ and is dissatisfied with the decision of the 
ALJ, or if the beneficiary requests a hearing and no hearing is 
conducted, and the beneficiary is dissatisfied with the decision of an 
ALJ or attorney adjudicator, he or she may request the Council to 
review the case. If the Council reviews the case and issues a decision, 
and the beneficiary is dissatisfied with the decision, the beneficiary 
may file suit in Federal district court if the amount remaining in 
controversy and the other requirements for judicial review are met.
* * * * *


Sec.  405.906  [Amended]

0
6. Section 405.906(b) introductory text is amended by--
0
a. Removing from the paragraph heading the phrase ``hearing and MAC'' 
and adding ``proceedings on a request for hearing, and Council review'' 
in its place.
0
b. Removing the phrase ``hearing, and MAC review'' and adding 
``proceedings on a request for hearing, and Council review'' in its 
place.


Sec.  405.908  [Amended]

0
7. Section 405.908 is amended by--
0
a. Removing the term ``ALJ'' and adding ``OMHA'' in its place.
0
b. Removing the term ``MAC'' and adding ``Council'' in its place.
0
8. Section 405.910 is amended by--
0
a. Revising paragraph (c)(5).
0
b. Adding paragraph (d)(3).
0
c. Revising paragraphs (f)(1), (i)(2), and (3).
0
d. Revising paragraph (l).
0
e. Adding paragraph (m)(4).
    The additions and revisions read as follows:


Sec.  405.910  Appointed representatives.

* * * * *
    (c) * * *
    (5) Identify the beneficiary's Medicare health insurance claim 
number when the beneficiary is the party appointing a representative, 
or identify the Medicare National Provider Identifier number of the 
provider or supplier that furnished the item or service when the 
provider or supplier is the party appointing a representative;
* * * * *
    (d) * * *
    (3) If an adjudication time frame applies, the time from the later 
of the date that a defective appointment of representative was filed or 
the current appeal request was filed by the prospective appointed 
representative, to the date when the defect was cured or the party 
notifies the adjudicator that he or she will proceed with the appeal 
without a representative does not count towards the adjudication time 
frame.
* * * * *
    (f) * * *
    (1) General rule. An appointed representative for a beneficiary who 
wishes to charge a fee for services rendered in connection with an 
appeal before the Secretary must obtain approval of the fee from the 
Secretary. Services rendered below the OMHA level are not considered 
proceedings before the Secretary.
* * * * *
    (i) * * *
    (2) Appeals. When a contractor, QIC, ALJ or attorney adjudicator, 
or the Council takes an action or issues a redetermination, 
reconsideration, or appeal decision, in connection with an initial 
determination, it sends notice of the action to the appointed 
representative.
    (3) The contractor, QIC, ALJ or attorney adjudicator, or Council 
sends any requests for information or evidence regarding a claim that 
is appealed to the appointed representative. The contractor sends any 
requests for information or evidence regarding an initial determination 
to the party.
* * * * *
    (l) Delegation of appointment by appointed representative. (1) An 
appointed representative may not designate another individual to act as 
the appointed representative of the party unless--
    (i) The appointed representative provides written notice to the 
party of the appointed representative's intent to delegate to another 
individual, which contains the name of the designee and the designee's 
acceptance to be obligated by and comply with the requirements of 
representation under this subpart; and
    (ii) The party accepts the designation as evidenced by a written 
statement signed by the party. The written statement signed by the 
party is not required when the appointed representative and designee 
are attorneys in the same law firm or organization and the notice 
described in paragraph (l)(1)(i) of this section so indicates.
    (2) A delegation is not effective until the adjudicator receives a 
copy of the acceptance described in paragraph (l)(1)(ii) of this 
section, unless the appointed representative and designee are attorneys 
in the same law firm or organization, in which case the notice 
described in paragraph (l)(1)(i) of this section may be submitted even 
though the acceptance described in paragraph (l)(1)(ii) of this section 
is not required.
    (3) A party's or representative's failure to notify the adjudicator 
that an appointment of representative has been delegated is not good 
cause for missing a deadline or not appearing at a hearing.
    (m) * * *
    (4) A party's or representative's failure to notify the adjudicator 
that an appointment of representative has been revoked is not good 
cause for missing a deadline or not appearing at a hearing.
0
9. Section 405.926 is amended by revising paragraphs (l) and (m) to 
read as follows:


Sec.  405.926  Actions that are not initial determinations.

* * * * *
    (l) A contractor's, QIC's, ALJ's or attorney adjudicator's, or 
Council's determination or decision to reopen or not to reopen an 
initial determination, redetermination, reconsideration, decision, or 
review decision.
    (m) Determinations that CMS or its contractors may participate in 
the proceedings on a request for an ALJ hearing or act as parties in an 
ALJ hearing or Council review.
* * * * *


Sec.  405.956  [Amended]

0
10. Section 405.956(b)(8) is amended by removing the phrase ``an ALJ 
hearing'' and adding ``the OMHA level'' in its place.
0
11. Section 405.968 is amended by revising paragraph (b)(1) to read as 
follows:


Sec.  405.968  Conduct of a reconsideration.

* * * * *
    (b) * * *
    (1) National coverage determinations (NCDs), CMS Rulings, Council 
decisions designated by the Chair of the Departmental Appeals Board as 
having precedential effect under Sec.  401.109 of this chapter, and 
applicable laws and regulations are binding on the QIC.
* * * * *

[[Page 43859]]

0
12. Section 405.970 is amended by revising the section heading and 
paragraphs (a) introductory text, (b), (c) introductory text, (e)(1), 
(e)(2)(i) and (ii) to read as follows:


Sec.  405.970  Timeframe for making a reconsideration following a 
contractor redetermination.

    (a) General rule. Within 60 calendar days of the date the QIC 
receives a timely filed request for reconsideration following a 
contractor redetermination or any additional time provided by paragraph 
(b) of this section, the QIC mails, or otherwise transmits to the 
parties at their last known addresses, written notice of--
* * * * *
    (b) Exceptions. (1) If a QIC grants an appellant's request for an 
extension of the 180 calendar day filing deadline made in accordance 
with Sec.  405.962(b), the QIC's 60 calendar day decision-making 
timeframe begins on the date the QIC receives the late filed request 
for reconsideration following a contractor redetermination, or when the 
request for an extension that meets the requirements of Sec.  
405.962(b) is granted, whichever is later.
    (2) If a QIC receives timely requests for reconsideration following 
a contractor redetermination from multiple parties, consistent with 
Sec.  405.964(c), the QIC must issue a reconsideration, notice that it 
cannot complete its review, or dismissal within 60 calendar days for 
each submission of the latest filed request.
    (3) Each time a party submits additional evidence after the request 
for reconsideration following a contractor redetermination is filed, 
the QIC's 60 calendar day decisionmaking timeframe is extended by up to 
14 calendar days for each submission, consistent with Sec.  405.966(b).
    (c) Responsibilities of the QIC. Within 60 calendar days of 
receiving a request for a reconsideration following a contractor 
redetermination, or any additional time provided for under paragraph 
(b) of this section, a QIC must take one of the following actions:
* * * * *
    (e) * * *
    (1) If the appellant fails to notify the QIC, or notifies the QIC 
that the appellant does not choose to escalate the case, the QIC 
completes its reconsideration following a contractor redetermination 
and notifies the appellant of its action consistent with Sec.  405.972 
or Sec.  405.976.
    (2) * * *
    (i) Complete its reconsideration following a contractor 
redetermination and notify all parties of its decision consistent with 
Sec.  405.972 or Sec.  405.976.
    (ii) Acknowledge the escalation notice in writing and forward the 
case file to OMHA.
0
13. Section 405.972 is amended by--
0
a. Revising the section heading.
0
b. Amending paragraph (b)(3) by removing the phrase ``reconsideration 
of a contractor's dismissal'' and adding ``review of a contractor's 
dismissal'' in its place.
0
c. Amending paragraph (e) by adding the phrase ``or attorney 
adjudicator'' after the phrase ``modified or reversed by an ALJ'' and 
removing the phrase ``reconsideration of a contractor's dismissal'' and 
adding ``review of a contractor's dismissal'' in its place.
    The revision reads as follows:


Sec.  405.972  Withdrawal or dismissal of a request for reconsideration 
or review of a contractor's dismissal of a request for redetermination.

* * * * *
0
14. Section 405.974 is amended by--
0
a. Revising the section heading.
0
b. Amending the heading to paragraph (b) by removing the phrase 
``Reconsideration of contractor's'' and adding ``Review of a 
contractor's'' in its place.
0
c. Amending paragraph (b)(3) by removing the word ``reconsideration'' 
and adding ``review'' in its place.
    The revision reads as follows:


Sec.  405.974  Reconsideration and review of a contractor's dismissal 
of a request for redetermination.

* * * * *
0
15. Section 405.976 is amended by--
0
a. Amending paragraph (b)(5)(ii) by removing the phrase ``at an ALJ 
level, or made part of the administrative record'' and adding ``at the 
OMHA level'' in its place.
0
b. Revising paragraph (b)(7) to read as follows:


Sec.  405.976  Notice of a reconsideration.

* * * * *
    (b) * * *
    (7) A statement of whether the amount in controversy is estimated 
to meet or not meet the amount required for an ALJ hearing, if--
    (i) The request for reconsideration was filed by a beneficiary who 
is not represented by a provider, supplier, or Medicaid State agency; 
and
    (ii) The reconsideration decision is partially or fully 
unfavorable.
* * * * *


Sec.  405.978  [Amended]

0
16. Section 405.978(a) is amended by removing the phrase ``An ALJ 
decision'' and adding ``An ALJ or attorney adjudicator decision'' in 
its place.
0
17. Section 405.980 is amended by revising the section heading and 
paragraphs (a)(1)(iii) and (iv), (a)(4) and (5), (d) paragraph heading, 
(d)(2) and (3), (e) paragraph heading, and (e)(2) and (3) to read as 
follows:


Sec.  405.980  Reopening of initial determinations, redeterminations, 
reconsiderations, decisions, and reviews.

    (a) * * *
    (1) * * *
    (iii) An ALJ or attorney adjudicator to revise his or her decision; 
or
    (iv) The Council to revise the ALJ or attorney adjudicator 
decision, or its review decision.
* * * * *
    (4) When a party has filed a valid request for an appeal of an 
initial determination, redetermination, reconsideration, ALJ or 
attorney adjudicator decision, or Council review, no adjudicator has 
jurisdiction to reopen an issue on a claim that is under appeal until 
all appeal rights for that issue are exhausted. Once the appeal rights 
for the issue have been exhausted, the contractor, QIC, ALJ or attorney 
adjudicator, or Council may reopen as set forth in this section.
    (5) The contractor's, QIC's, ALJ's or attorney adjudicator's, or 
Council's decision on whether to reopen is binding and not subject to 
appeal.
* * * * *
    (d) Time frame and requirements for reopening reconsiderations, 
decisions and reviews initiated by a QIC, ALJ or attorney adjudicator, 
or the Council.
* * * * *
    (2) An ALJ or attorney adjudicator may reopen his or her decision, 
or the Council may reopen an ALJ or attorney adjudicator decision on 
its own motion within 180 calendar days from the date of the decision 
for good cause in accordance with Sec.  405.986. If the decision was 
procured by fraud or similar fault, then the ALJ or attorney 
adjudicator may reopen his or her decision, or the Council may reopen 
an ALJ or attorney adjudicator decision, at any time.
    (3) The Council may reopen its review decision on its own motion 
within 180 calendar days from the date of the review decision for good 
cause in accordance with Sec.  405.986. If the Council's decision was 
procured by fraud or similar fault, then the Council may reopen at any 
time.
    (e) Time frames and requirements for reopening reconsiderations, 
decisions, and reviews requested by a party.
* * * * *

[[Page 43860]]

    (2) A party to an ALJ or attorney adjudicator decision may request 
that an ALJ or attorney adjudicator reopen his or her decision, or the 
Council reopen an ALJ or attorney adjudicator decision, within 180 
calendar days from the date of the decision for good cause in 
accordance with Sec.  405.986.
    (3) A party to a Council review may request that the Council reopen 
its decision within 180 calendar days from the date of the review 
decision for good cause in accordance with Sec.  405.986.


Sec.  405.982  [Amended]

0
18. Section 405.982(a) and (b) are amended by removing the phrase 
``ALJ, or the MAC'' and adding the phrase ``ALJ or attorney 
adjudicator, or the Council'' in its place.
0
19. Section 405.984 is amended by--
0
a. Amending paragraph (c) by removing the phrase ``in accordance with 
Sec.  405.1000 through Sec.  405.1064'' and adding ``in accordance with 
Sec.  405.1000 through Sec.  405.1063'' in its place.
0
b. Revising paragraphs (d) and (e) to read as follows:


Sec.  405.984  Effect of a revised determination or decision.

* * * * *
    (d) ALJ or attorney adjudicator decisions. The revision of an ALJ 
or attorney adjudicator decision is binding upon all parties unless a 
party files a written request for a Council review that is accepted and 
processed in accordance with Sec.  405.1100 through Sec.  405.1130.
    (e) Council review. The revision of a Council review is binding 
upon all parties unless a party files a civil action in which a Federal 
district court accepts jurisdiction and issues a decision.
* * * * *
0
20. Section 405.990 is amended by--
0
a. Amending paragraph (a)(2) by removing the phrase ``Medicare Appeals 
Council (MAC)'' and adding the term ``Council'' in its place.
0
b. Amending paragraphs (b)(1) introductory text, (b)(1)(i)(B), (b)(4), 
and (d)(2)(ii) by removing the term ``MAC'' each time it appears and 
adding ``Council'' in its place.
0
c. Amending paragraph (b)(1)(i)(A) by removing the phrase ``the ALJ 
has'' and adding ``the ALJ or attorney adjudicator has'' in its place.
0
d. Amending paragraph (b)(1)(ii) by removing the phrase ``to the ALJ 
level'' and adding ``to OMHA for an ALJ hearing'' in its place.
0
e. Amending paragraphs (c)(3), (4), and (5) by removing the term ``ALJ 
hearing decision'' and adding ``ALJ or attorney adjudicator decision'' 
in its place.
0
h. Revising paragraph (d)(1).
0
i. Amending paragraph (d)(2)(i) by removing the term ``ALJ's'' and 
adding ``ALJ's or attorney adjudicator's'' in its place.
0
j. Amending paragraph (d)(2)(ii) by removing the term ``MAC's'' and 
adding ``Council's'' in its place.
0
k. Revising paragraphs (i)(1) and (2).
    The revisions read as follows:


Sec.  405.990  Expedited access to judicial review.

* * * * *
    (d) * * *
    (1) Method and place for filing request. The requestor may--
    (i) If a request for ALJ hearing or Council review is not pending, 
file a written EAJR request with the HHS Departmental Appeals Board 
with his or her request for an ALJ hearing or Council review; or
    (ii) If an appeal is already pending for an ALJ hearing or 
otherwise before OMHA, or the Council, file a written EAJR request with 
the HHS Departmental Appeals Board.
* * * * *
    (i) * * *
    (1) If a request for EAJR does not meet all the conditions set out 
in paragraphs (b), (c) and (d) of this section, or if the review entity 
does not certify a request for EAJR, the review entity advises in 
writing all parties that the request has been denied, and forwards the 
request to OMHA or the Council, which will treat it as a request for 
hearing or for Council review, as appropriate.
    (2) Whenever a review entity forwards a rejected EAJR request to 
OMHA or the Council, the appeal is considered timely filed, and if an 
adjudication time frame applies to the appeal, the adjudication time 
frame begins on the day the request is received by OMHA or the Council 
from the review entity.
* * * * *
0
21. Section 405.1000 is revised to read as follows:


Sec.  405.1000  Hearing before an ALJ and decision by an ALJ or 
attorney adjudicator: General rule.

    (a) If a party is dissatisfied with a QIC's reconsideration, or if 
the adjudication period specified in Sec.  405.970 for the QIC to 
complete its reconsideration has elapsed, the party may request a 
hearing before an ALJ.
    (b) A hearing before an ALJ may be conducted in-person, by video-
teleconference (VTC), or by telephone. At the hearing, the parties may 
submit evidence (subject to the restrictions in Sec.  405.1018 and 
Sec.  405.1028), examine the evidence used in making the determination 
under review, and present and/or question witnesses.
    (c) In some circumstances, CMS or its contractor may participate in 
the proceedings under Sec.  405.1010, or join the hearing before an ALJ 
as a party under Sec.  405.1012.
    (d) The ALJ or attorney adjudicator conducts a de novo review and 
issues a decision based on the administrative record, including, for an 
ALJ, any hearing record.
    (e) If all parties who are due a notice of hearing in accordance 
with Sec.  405.1020(c) waive their right to appear at the hearing in 
person or by telephone or video-teleconference, the ALJ or an attorney 
adjudicator may make a decision based on the evidence that is in the 
file and any new evidence that is submitted for consideration.
    (f) The ALJ may require the parties to participate in a hearing if 
it is necessary to decide the case. If the ALJ determines that it is 
necessary to obtain testimony from a non-party, he or she may hold a 
hearing to obtain that testimony, even if all of the parties who are 
entitled to a notice of hearing in accordance with Sec.  405.1020(c) 
have waived the right to appear. In that event, however, the ALJ will 
give the parties the opportunity to appear when the testimony is given, 
but may hold the hearing even if none of the parties decide to appear.
    (g) An ALJ or attorney adjudicator may also issue a decision on the 
record on his or her own initiative if the evidence in the 
administrative record supports a fully favorable finding for the 
appellant, and there is no other party or no other party is entitled to 
a notice of hearing in accordance with Sec.  405.1020(c).
    (h) If more than one party timely files a request for hearing on 
the same claim before a decision is made on the first timely filed 
request, the requests are consolidated into one proceeding and record, 
and one decision, dismissal, or remand is issued.


Sec.  405.1002  [Amended]

0
22. Section 405.1002 is amended by--
0
a. Amending paragraph (a) introductory text by removing the phrase 
``may request'' and adding ``has a right to'' in its place
0
b. Amending paragraph (a)(4) by removing the word ``entity'' and adding 
``office'' in its place.
0
c. Amending paragraph (b)(1) by removing the phrase ``to the ALJ 
level'' and adding ``for a hearing before an ALJ'' in its place.
0
23. Section 405.1004 is amended by--
0
a. Revising the section heading and paragraphs (a) introductory text, 
(a)(1) and (4), (b), and (c).
0
b. Adding paragraph (d).
    The revisions and addition read as follows:

[[Page 43861]]

Sec.  405.1004  Right to a review of QIC notice of dismissal.

    (a) A party to a QIC's dismissal of a request for reconsideration 
has a right to have the dismissal reviewed by an ALJ or attorney 
adjudicator if--
    (1) The party files a written request for review within 60 calendar 
days after receipt of the notice of the QIC's dismissal.
* * * * *
    (4) For purposes of meeting the 60 calendar day filing deadline, 
the request is considered as filed on the date it is received by the 
office specified in the QIC's dismissal.
    (b) If the ALJ or attorney adjudicator determines that the QIC's 
dismissal was in error, he or she vacates the dismissal and remands the 
case to the QIC for a reconsideration in accordance with Sec.  
405.1056.
    (c) If the ALJ or attorney adjudicator affirms the QIC's dismissal 
of a reconsideration request, he or she issues a notice of decision 
affirming the QIC dismissal in accordance with Sec.  405.1046(b).
    (d) The ALJ or attorney adjudicator may dismiss the request for 
review of a QIC's dismissal in accordance with Sec.  405.1052(b).
0
24. Section 405.1006 is amended by--
0
a. Revising the section heading and paragraphs (d)(1) introductory 
text, (d)(1)(ii), and (d)(2).
0
b. Adding paragraphs (d)(3) through (7).
0
c. Revising paragraphs (e)(1) introductory text, (e)(1)(ii) and (iii), 
(e)(2) introductory text, and (e)(2)(ii) and (iii).
    The revisions and additions read as follows:


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

* * * * *
    (d) * * *
    (1) In general. In situations other than those described in 
paragraphs (d)(3) through (7) of this section, the amount remaining in 
controversy is computed as the basis for the amount in controversy for 
the items and services in the disputed claim, as defined in paragraph 
(d)(2) of this section, reduced by--
* * * * *
    (ii) Any deductible and/or coinsurance amounts that may be 
collected for the items or services.
    (2) Basis for the amount in controversy. For purposes of 
calculating the amount in controversy under paragraph (d)(1) of this 
section, the basis for the amount in controversy is defined as follows:
    (i) General rule. For situations other than those described in 
paragraphs (d)(2)(ii) and (iii) of this section, the basis for the 
amount in controversy is determined as follows:
    (A) For items and services with a published Medicare fee schedule 
or published contractor-priced amount, the basis for the amount in 
controversy is the allowable amount, which is the amount reflected on 
the fee schedule or in the contractor-priced amount for those items or 
services in the applicable jurisdiction and place of service.
    (B) For items and services with no published Medicare fee schedule 
or published contractor-priced amount, the basis for the amount in 
controversy is the billed charges submitted on the claim for those 
items or services.
    (ii) Beneficiary financial responsibility. For items and services 
for which a beneficiary has been determined to be financially 
responsible, the basis for the amount in controversy is the actual 
amount charged to the beneficiary (or the maximum amount the 
beneficiary may be charged if no bill has been received) for the items 
and services in the disputed claim.
    (iii) Refunds of amounts previously collected. If a beneficiary 
received or may be entitled to a refund of the amount the beneficiary 
previously paid to the provider or supplier for the items or services 
in the disputed claim under applicable statutory or regulatory 
authority, the basis for the amount in controversy is the actual amount 
originally charged to the beneficiary for those items or services.
    (3) Limitation on liability. When payment is made for items or 
services under section 1879 of the Act or Sec.  411.400 of this 
chapter, or the liability of the beneficiary for those services is 
limited under Sec.  411.402 of this chapter, the amount in controversy 
is calculated in accordance with paragraphs (d)(1) and (d)(2)(i) of 
this section, except there is no deduction under paragraph (d)(1)(i) 
for expenses that are paid under Sec.  411.400 of this chapter or as a 
result of liability that is limited under Sec.  411.402 of this 
chapter.
    (4) Item or service terminations. When a matter involves a provider 
or supplier termination of Medicare-covered items or services that is 
disputed by a beneficiary, and the beneficiary did not elect to 
continue receiving the items or services, the amount in controversy is 
calculated in accordance with paragraphs (d)(1) and (d)(2)(ii) of this 
section, except that the basis for the amount in controversy and any 
deductible and coinsurance that may be collected for the items or 
services are calculated using the amount the beneficiary would have 
been charged if the beneficiary had received the items or services the 
beneficiary asserts should have been covered based on the beneficiary's 
current condition, and Medicare payment were not made for the items or 
services.
    (5) Overpayments. Notwithstanding paragraphs (d)(1) and (2) of this 
section, when an appeal involves an identified overpayment, the amount 
in controversy is the amount of the overpayment specified in the demand 
letter for the items or services in the disputed claim. When an appeal 
involves an estimated overpayment amount determined through the use of 
statistical sampling and extrapolation, the amount in controversy is 
the total amount of the estimated overpayment determined through 
extrapolation, as specified in the demand letter.
    (6) Coinsurance and deductible challenges. Notwithstanding 
paragraphs (d)(1) and (2) of this section, for appeals filed by 
beneficiaries challenging only the computation of a coinsurance amount 
or the amount of a remaining deductible, the amount in controversy is 
the difference between the amount of the coinsurance or remaining 
deductible, as determined by the contractor, and the amount of the 
coinsurance or remaining deductible the beneficiary believes is 
correct.
    (7) Fee schedule or contractor price challenges. Notwithstanding 
paragraphs (d)(1) and (2) of this section, for appeals of claims where 
the allowable amount has been paid in full and the appellant is 
challenging only the validity of the allowable amount, as reflected on 
the published fee schedule or in the published contractor-priced amount 
applicable to the items or services in the disputed claim, the amount 
in controversy is the difference between the amount the appellant 
argues should have been the allowable amount for the items or services 
in the disputed claim in the applicable jurisdiction and place of 
service, and the published allowable amount for the items or services.
    (e) * * *
    (1) Aggregating claims in appeals of QIC reconsiderations for an 
ALJ hearing. Either an individual appellant or multiple appellants may 
aggregate two or more claims to meet the amount in controversy for an 
ALJ hearing if--
* * * * *
    (ii) The appellant(s) requests aggregation of claims appealed in 
the same request for ALJ hearing, or in multiple requests for an ALJ 
hearing filed with the same request for aggregation, and the request is 
filed

[[Page 43862]]

within 60 calendar days after receipt of all of the reconsiderations 
being appealed; and
    (iii) The claims that a single appellant seeks to aggregate involve 
the delivery of similar or related services, or the claims that 
multiple appellants seek to aggregate involve common issues of law and 
fact, as determined by an ALJ or attorney adjudicator. Only an ALJ may 
determine the claims that a single appellant seeks to aggregate do not 
involve the delivery of similar or related services, or the claims that 
multiple appellants seek to aggregate do not involve common issues of 
law and fact. Part A and Part B claims may be combined to meet the 
amount in controversy requirements.
    (2) Aggregating claims that are escalated from the QIC level for an 
ALJ hearing. Either an individual appellant or multiple appellants may 
aggregate two or more claims to meet the amount in controversy for an 
ALJ hearing if--
* * * * *
    (ii) The appellant(s) requests aggregation of the claims for an ALJ 
hearing in the same request for escalation; and
    (iii) The claims that a single appellant seeks to aggregate involve 
the delivery of similar or related services, or the claims that 
multiple appellants seek to aggregate involve common issues of law and 
fact, as determined by an ALJ or attorney adjudicator. Only an ALJ may 
determine the claims that a single appellant seeks to aggregate do not 
involve the delivery of similar or related services, or the claims that 
multiple appellants seek to aggregate do not involve common issues of 
law and fact. Part A and Part B claims may be combined to meet the 
amount in controversy requirements.
* * * * *
0
25. Section 405.1008 is revised to read as follows:


Sec.  405.1008  Parties to the proceedings on a request for an ALJ 
hearing.

    The party who filed the request for hearing and all other parties 
to the reconsideration are parties to the proceedings on a request for 
an ALJ hearing. In addition, a representative of CMS or its contractor 
may be a party under the circumstances described in Sec.  405.1012.
0
26. Section 405.1010 is revised to read as follows:


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

    (a) When CMS or a contractor can participate. (1) CMS or its 
contractors may elect to participate in the proceedings on a request 
for an ALJ hearing upon filing a notice of intent to participate in 
accordance with paragraph (b) of this section.
    (2) An ALJ may request, but may not require, CMS and/or one or more 
of its contractors to participate in any proceedings before the ALJ, 
including the oral hearing, if any. The ALJ cannot draw any adverse 
inferences if CMS or the contractor decides not to participate in any 
proceedings before the ALJ, including the hearing.
    (b) How an election is made. (1) No notice of hearing. If CMS or a 
contractor elects to participate before receipt of a notice of hearing, 
or when a notice of hearing is not required, it must send written 
notice of its intent to participate to the assigned ALJ or attorney 
adjudicator, or a designee of the Chief ALJ if the request for hearing 
is not yet assigned to an ALJ or attorney adjudicator, and the parties 
who were sent a copy of the notice of reconsideration.
    (2) Notice of hearing. If CMS or a contractor elects to participate 
after receipt of a notice of hearing, it must send written notice of 
its intent to participate to the ALJ and the parties who were sent a 
copy of the notice of hearing.
    (3) Timing of election. CMS or a contractor must send its notice of 
intent to participate--
    (i) If no hearing is scheduled, no later than 30 calendar days 
after notification that a request for hearing was filed; or
    (ii) If a hearing is scheduled, no later than 10 calendar days 
after receiving the notice of hearing.
    (c) Roles and responsibilities of CMS or a contractor as a 
participant. (1) Subject to paragraphs (d)(1) through (d)(3) of this 
section, participation may include filing position papers and/or 
providing testimony to clarify factual or policy issues in a case, but 
it does not include calling witnesses or cross-examining the witnesses 
of a party to the hearing.
    (2) When CMS or its contractor participates in an ALJ hearing, CMS 
or its contractor may not be called as a witness during the hearing and 
is not subject to examination or cross-examination by the parties. 
However, the parties may provide testimony to rebut factual or policy 
statements made by a participant and the ALJ may question the 
participant about its testimony.
    (3) CMS or contractor position papers and written testimony are 
subject to the following:
    (i) A position paper or written testimony must be submitted by 
within 14 calendar days of an election to participate if no hearing has 
been scheduled, or no later than 5 calendar days prior to the hearing 
if a hearing is scheduled unless the ALJ grants additional time to 
submit the position paper or written testimony.
    (ii) A copy of any position paper or written testimony it submits 
to OMHA must be sent to--
    (A) The parties who were sent a copy of the notice of 
reconsideration, if the position paper or written testimony is being 
submitted before receipt of a notice of hearing for the appeal; or
    (B) The parties who were sent a copy of the notice of hearing, if 
the position paper or written testimony is being submitted after 
receipt of a notice of hearing for the appeal.
    (iii) If CMS or a contractor fails to send a copy of its position 
paper or written testimony to the parties or fails to submit its 
position paper or written testimony within the time frames described in 
this paragraph, the position paper or written testimony will not be 
considered in deciding the appeal.
    (d) Limitation on participating in a hearing. (1) If CMS or a 
contractor has been made a party to a hearing in accordance with Sec.  
405.1012, no entity that elected to be a participant in the proceedings 
in accordance with this section (or that elected to be a party to the 
hearing but was made a participant in accordance with Sec.  
405.1012(d)(1)) may participate in the oral hearing, but such entity 
may file a position paper and/or written testimony to clarify factual 
or policy issues in the case.
    (2) If CMS or a contractor did not elect to be a party to a hearing 
in accordance with Sec.  405.1012 and more than one entity elected to 
be a participant in the proceedings in accordance with this section, 
only the first entity to file a response to the notice of hearing as 
provided under Sec.  405.1020(c) may participate in the oral hearing. 
Entities that filed a subsequent response to the notice of hearing may 
not participate in the oral hearing, but may file a position paper and/
or written testimony to clarify factual or policy issues in the case.
    (3) If CMS or a contractor is precluded from participating in the 
oral hearing under paragraph (d)(1) or (2) of this section, the ALJ may 
grant leave to the precluded entity to participate in the oral hearing 
if the ALJ determines that the entity's participation is necessary for 
a full examination of the matters at issue.
    (e) Invalid election. (1) An ALJ or attorney adjudicator may 
determine that a CMS or contractor election is invalid under this 
section if the election was

[[Page 43863]]

not timely filed or the election was not sent to the correct parties.
    (2) If an election is determined to be invalid, a written notice 
must be sent to the entity that submitted the election and the parties 
who are entitled to receive notice of the election in accordance with 
this section.
    (i) If no hearing is scheduled or the election was submitted after 
the hearing occurred, the written notice of invalid election must be 
sent no later than the date the notice of decision, dismissal, or 
remand is mailed.
    (ii) If a hearing is scheduled, the written notice of invalid 
election must be sent prior to the hearing. If the notice would be sent 
fewer than 5 calendar days before the hearing is scheduled to occur, 
oral notice must be provided to the entity that submitted the election, 
and the written notice must be sent as soon as possible after the oral 
notice is provided.
0
27. Section 405.1012 is revised to read as follows:
* * * * *


Sec.  405.1012  When CMS or its contractors may be a party to a 
hearing.

    (a) When CMS or a contractor can elect to be a party to a hearing. 
(1) Unless the request for hearing is filed by an unrepresented 
beneficiary, and unless otherwise provided in this section, CMS or one 
of its contractors may elect to be a party to the hearing upon filing a 
notice of intent to be a party to the hearing in accordance with 
paragraph (b) of this section no later than 10 calendar days after the 
QIC receives the notice of hearing.
    (2) An ALJ may request, but may not require, CMS and/or one or more 
of its contractors to be a party to the hearing. The ALJ cannot draw 
any adverse inferences if CMS or the contractor decides not to be a 
party to the hearing.
    (b) How an election is made. If CMS or a contractor elects to be a 
party to the hearing, it must send written notice to the ALJ and the 
parties identified in the notice of hearing of its intent to be a party 
to the hearing.
    (c) Roles and responsibilities of CMS or a contractor as a party. 
(1) As a party, CMS or a contractor may file position papers, submit 
evidence, provide testimony to clarify factual or policy issues, call 
witnesses or cross-examine the witnesses of other parties.
    (2) CMS or contractor position papers, written testimony, and 
evidentiary submissions are subject to the following:
    (i) Any position paper, written testimony, and/or evidence must be 
submitted no later than 5 calendar days prior to the hearing unless the 
ALJ grants additional time to submit the position paper, written 
testimony, and/or evidence.
    (ii) A copy of any position paper, written testimony, and/or 
evidence it submits to OMHA must be sent to the parties who were sent a 
copy of the notice of hearing.
    (iii) If CMS or a contractor fails to send a copy of its position 
paper, written testimony, and/or evidence to the parties or fails to 
submit its position paper, written testimony, and/or evidence within 
the time frames described in this section, the position paper, written 
testimony, and/or evidence will not be considered in deciding the 
appeal.
    (d) Limitation on participating in a hearing. (1) If CMS and one or 
more contractors, or multiple contractors, file an election to be a 
party to the hearing, the first entity to file its election after the 
notice of hearing is issued is made a party to the hearing and the 
other entities are made participants in the proceedings under Sec.  
405.1010, subject to Sec.  405.1010(d)(1) and (3), unless the ALJ 
grants leave to an entity to also be a party to the hearing in 
accordance with paragraph (d)(2) of this section.
    (2) If CMS or a contractor filed an election to be a party in 
accordance with this section but is precluded from being made a party 
under paragraph (d)(1) of this section, the ALJ may grant leave to be a 
party to the hearing if the ALJ determines that the entity's 
participation as a party is necessary for a full examination of the 
matters at issue.
    (e) Invalid election. (1) An ALJ or attorney adjudicator may 
determine that a CMS or contractor election is invalid under this 
section if the request for hearing was filed by an unrepresented 
beneficiary, the election was not timely, the election was not sent to 
the correct parties, or CMS or a contractor had already filed an 
election to be a party to the hearing and the ALJ did not determine 
that the entity's participation as a party is necessary for a full 
examination of the matters at issue.
    (2) If an election is determined to be invalid, a written notice 
must be sent to the entity that submitted the election and the parties 
who were sent the notice of hearing.
    (i) If the election was submitted after the hearing occurred, the 
written notice of invalid election must be sent no later than the date 
the decision, dismissal, or remand notice is mailed.
    (ii) If the election was submitted before the hearing occurs, the 
written notice of invalid election must be sent prior to the hearing. 
If the notice would be sent fewer than 5 calendar days before the 
hearing is scheduled to occur, oral notice must be provided to the 
entity that submitted the election, and the written notice to the 
entity and the parties who were sent the notice of hearing must be sent 
as soon as possible after the oral notice is provided.
0
28. Section 405.1014 is revised to read as follows:


Sec.  405.1014  Request for an ALJ hearing or a review of a QIC 
dismissal.

    (a) Content of the request. (1) The request for an ALJ hearing or a 
review of a QIC dismissal must be made in writing. The request must 
include all of the following--
    (i) The name, address, and Medicare health insurance claim number 
of the beneficiary whose claim is being appealed, and the beneficiary's 
telephone number if the beneficiary is the appealing party and not 
represented.
    (ii) The name, address, and telephone number, of the appellant, 
when the appellant is not the beneficiary.
    (iii) The name, address, and telephone number, of the designated 
representative, if any.
    (iv) The Medicare appeal number or document control number, if any, 
assigned to the QIC reconsideration or dismissal notice being appealed.
    (v) The dates of service of the claim(s) being appealed, if 
applicable.
    (vi) The reasons the appellant disagrees with the QIC's 
reconsideration or other determination being appealed.
    (vii) A statement of whether the filing party is aware that it or 
the claim is the subject of an investigation or proceeding by the HHS 
Office of Inspector General or other law enforcement agencies.
    (viii) For requests filed by providers, suppliers, Medicaid State 
agencies, applicable plans, or a beneficiary who is represented by a 
provider, supplier or Medicaid State agency, the amount in controversy 
applicable to the disputed claim determined in accordance with Sec.  
405.1006, unless the matter involves a provider or supplier termination 
of Medicare-covered items or services that is disputed by a 
beneficiary, and the beneficiary did not elect to continue receiving 
the items or services.
    (2) The appellant must submit a statement of any additional 
evidence to be submitted and the date it will be submitted.
    (3) Special rule for appealing statistical sample and/or 
extrapolation. If the appellant disagrees with how a statistical sample 
and/or extrapolation was conducted, the appellant must--
    (i) Include the information in paragraphs (a)(1) and (2) of this 
section for each sample claim that the appellant wishes to appeal;
    (ii) File the request for hearing for all sampled claims that the 
appellant

[[Page 43864]]

wishes to appeal within 60 calendar days of the date the party receives 
the last reconsideration for the sample claims, if they were not all 
addressed in a single reconsideration; and
    (iii) Assert the reasons the appellant disagrees with how the 
statistical sample and/or extrapolation was conducted in the request 
for hearing.
    (b) Complete request required. (1) A request must contain the 
information in paragraph (a)(1) of this section to the extent the 
information is applicable, to be considered complete. If a request is 
not complete, the appellant will be provided with an opportunity to 
complete the request, and if an adjudication time frame applies, it 
does not begin until the request is complete. If the appellant fails to 
provide the information necessary to complete the request within the 
time frame provided, the appellant's request for hearing or review will 
be dismissed.
    (2) If supporting materials submitted with a request clearly 
provide information required for a complete request, the materials will 
be considered in determining whether the request is complete.
    (c) When and where to file. The request for an ALJ hearing or 
request for review of a QIC dismissal must be filed--
    (1) Within 60 calendar days from the date the party receives notice 
of the QIC's reconsideration or dismissal, except as provided in 
paragraph (a)(3)(ii) of this section for appeals of extrapolations;
    (2) With the office specified in the QIC's reconsideration or 
dismissal. If the request for hearing is timely filed with an office 
other than the office specified in the QIC's reconsideration, any 
applicable time frame specified in Sec.  405.1016 for deciding the 
appeal begins on the date the office specified in the QIC's 
reconsideration or dismissal receives the request for hearing. If the 
request for hearing is filed with an office, other than the entity 
office specified in the QIC's reconsideration or dismissal, OMHA must 
notify the appellant of the date the request was received in the 
correct office and the commencement of any applicable adjudication time 
frame.
    (d) Copy requirement. (1) The appellant must send a copy of the 
request for hearing or request for review of a QIC dismissal to the 
other parties who were sent a copy of the QIC's reconsideration or 
dismissal. If additional materials submitted with the request are 
necessary to provide the information required for a complete request in 
accordance with paragraph (b) of this section, copies of the materials 
must be sent to the parties as well (subject to authorities that apply 
to disclosing the personal information of other parties). If additional 
evidence is submitted with the request for hearing, the appellant may 
send a copy of the evidence, or briefly describe the evidence pertinent 
to the party and offer to provide copies of the evidence to the party 
at the party's request (subject to authorities that apply to disclosing 
the evidence).
    (2) Evidence that a copy of the request for hearing or request for 
review of a QIC dismissal, or a copy of submitted evidence or a summary 
thereof, was sent in accordance with paragraph (d)(1) of this section 
includes--
    (i) Certification on the standard form for requesting an ALJ 
hearing or requesting a review of a QIC dismissal that a copy of the 
request is being sent to the other parties;
    (ii) An indication, such as a copy or ``cc'' line, on a request for 
hearing or request for review of a QIC dismissal that a copy of the 
request and any applicable attachments or enclosures are being sent to 
the other parties, including the name and address of the recipient;
    (iii) An affidavit or certificate of service that identifies the 
name and address of the recipient, and what was sent to the recipient; 
or
    (iv) A mailing or shipping receipt that identifies the name and 
address of the recipient, and what was sent to the recipient.
    (3) If the appellant fails to send a copy of the request for 
hearing or request for review of a QIC dismissal, any additional 
materials, or a copy of submitted evidence or a summary thereof, as 
described in paragraph (d)(1) of this section, the appellant will be 
provided with an additional opportunity to send the request, materials, 
and/or evidence or summary thereof, and if an adjudication time frame 
applies, it begins upon receipt of evidence that the request, 
materials, and/or evidence or summary thereof were sent. If the 
appellant again fails to provide evidence that the request, materials, 
and/or evidence or summary thereof were sent within the additional time 
frame provided to send the request, materials, and/or evidence or 
summary thereof, the appellant's request for hearing or request for 
review of a QIC dismissal will be dismissed.
    (e) Extension of time to request a hearing or review. (1) If the 
request for hearing or review of a QIC dismissal is not filed within 60 
calendar days of receipt of the QIC's reconsideration or dismissal, an 
appellant may request an extension for good cause (See Sec.  
405.942(b)(2) and (3)).
    (2) Any request for an extension of time must be in writing, give 
the reasons why the request for a hearing or review was not filed 
within the stated time period, and must be filed with the request for 
hearing or request for review of a QIC dismissal with the office 
specified in the notice of reconsideration or dismissal.
    (3) An ALJ or attorney adjudicator may find there is good cause for 
missing the deadline to file a request for an ALJ hearing or request 
for review of a QIC dismissal, or there is no good cause for missing 
the deadline to file a request for a review of a QIC dismissal, but 
only an ALJ may find there is no good cause for missing the deadline to 
file a request for an ALJ hearing. If good cause is found for missing 
the deadline, the time period for filing the request for hearing or 
request for review of a QIC dismissal will be extended. To determine 
whether good cause for late filing exists, the ALJ or attorney 
adjudicator uses the standards set forth in Sec.  405.942(b)(2) and 
(3).
    (4) If a request for hearing is not timely filed, any applicable 
adjudication period in Sec.  405.1016 begins the date the ALJ or 
attorney adjudicator grants the request to extend the filing deadline.
    (5) A determination granting a request to extend the filing 
deadline is not subject to further review.
0
29. Section 405.1016 is revised to read as follows:


Sec.  405.1016  Time frames for deciding an appeal of a QIC 
reconsideration or escalated request for a QIC reconsideration.

    (a) Adjudication period for appeals of QIC reconsiderations. When a 
request for an ALJ hearing is filed after a QIC has issued a 
reconsideration, an ALJ or attorney adjudicator issues a decision, 
dismissal order, or remand to the QIC, as appropriate, no later than 
the end of the 90 calendar day period beginning on the date the request 
for hearing is received by the office specified in the QIC's notice of 
reconsideration, unless the 90 calendar day period has been extended as 
provided in this subpart.
    (b) When the adjudication period begins. (1) Unless otherwise 
specified in this subpart, the adjudication period specified in 
paragraph (a) of this section begins on the date that a timely filed 
request for hearing is received by the office specified in the QIC's 
reconsideration, or, if it is not timely filed, the date that the ALJ 
or attorney adjudicator grants any extension to the filing deadline.
    (2) If the Council remands a case and the case was subject to an 
adjudication time frame under paragraph (a) or (c) of this section, the 
remanded appeal will

[[Page 43865]]

be subject to the adjudication time frame of paragraph (a) of this 
section beginning on the date that OMHA receives the Council remand.
    (c) Adjudication period for escalated requests for QIC 
reconsiderations. When an appeal is escalated to OMHA because the QIC 
has not issued a reconsideration determination within the period 
specified in Sec.  405.970, an ALJ or attorney adjudicator issues a 
decision, dismissal order, or remand to the QIC, as appropriate, no 
later than the end of the 180 calendar day period beginning on the date 
that the request for escalation is received by OMHA in accordance with 
Sec.  405.970, unless the 180 calendar day period is extended as 
provided in this subpart.
    (d) Waivers and extensions of adjudication period. (1) At any time 
during the adjudication process, the appellant may waive the 
adjudication period specified in paragraphs (a) and (c) of this 
section. The waiver may be for a specific period of time agreed upon by 
the ALJ or attorney adjudicator and the appellant.
    (2) The adjudication periods specified in paragraphs (a) and (c) of 
this section are extended as otherwise specified in this subpart, and 
for the following events--
    (i) The duration of a stay of action on adjudicating the claims or 
matters at issue ordered by a court or tribunal of competent 
jurisdiction; or
    (ii) The duration of a stay of proceedings granted by an ALJ or 
attorney adjudicator on a motion by an appellant, provided no other 
party also filed a request for hearing on the same claim at issue.
    (e) Effect of exceeding adjudication period. If an ALJ or attorney 
adjudicator fails to issue a decision, dismissal order, or remand to 
the QIC within an adjudication period specified in this section, 
subject to paragraphs (b) and (d) of this section, the party that filed 
the request for hearing may escalate the appeal in accordance with 
paragraph (f) of this section. If the party that filed the request for 
hearing does not elect to escalate the appeal, the appeal remains 
pending with OMHA for a decision, dismissal order, or remand.
    (f) Requesting escalation. (1) When and how to request escalation. 
An appellant who files a timely request for hearing before an ALJ and 
whose appeal continues to be pending with OMHA at the end of the 
applicable adjudication period under paragraph (a) or (c) of this 
section, subject to paragraphs (b) and (d) of this section, may 
exercise the option of escalating the appeal to the Council by filing a 
written request with OMHA to escalate the appeal to the Council and 
sending a copy of the request to escalate to the other parties who were 
sent a copy of the QIC reconsideration.
    (2) Escalation. If the request for escalation meets the 
requirements of paragraph (f)(1) of this section and an ALJ or attorney 
adjudicator is not able to issue a decision, dismissal order, or remand 
order within the later of 5 calendar days of receiving the request for 
escalation, or 5 calendar days from the end of the applicable 
adjudication period set forth in paragraph (a) or (c) of this section, 
subject to paragraphs (b) and (d) of this section, OMHA will take the 
following actions--
    (i) Send a notice to the appellant stating that an ALJ or attorney 
adjudicator is not able to issue a decision, dismissal order, or remand 
order within the adjudication period set forth in paragraph (a) or (c) 
of this section, the QIC reconsideration will be the decision that is 
subject to Council review consistent with Sec.  405.1102(a), and the 
appeal will be escalated to the Council for a review in accordance with 
Sec.  405.1108; and
    (ii) Forward the case file to the Council.
    (3) Invalid escalation request. If an ALJ or attorney adjudicator 
determines the request for escalation does not meet the requirements of 
paragraph (f)(1) of this section, OMHA will send a notice to the 
appellant explaining why the request is invalid within 5 calendar days 
of receiving the request for escalation.
0
30. Section 405.1018 is revised to read as follows:


Sec.  405.1018  Submitting evidence.

    (a) When evidence may be submitted. Except as provided in this 
section, parties must submit all written or other evidence they wish to 
have considered with the request for hearing, by the date specified in 
the request for hearing in accordance with Sec.  405.1014(a)(2), or if 
a hearing is scheduled, within 10 calendar days of receiving the notice 
of hearing.
    (b) Effect on adjudication period. If a party submits written or 
other evidence later than 10 calendar days after receiving the notice 
of hearing, any applicable adjudication period specified in Sec.  
405.1016 is extended by the number of calendar days in the period 
between 10 calendar days after receipt of the notice of hearing and the 
day the evidence is received.
    (c) New evidence. (1) Any evidence submitted by a provider, 
supplier, or beneficiary represented by a provider or supplier that is 
not submitted prior to the issuance of the QIC's reconsideration 
determination must be accompanied by a statement explaining why the 
evidence was not previously submitted to the QIC, or a prior decision-
maker (see Sec.  405.1028).
    (2) If a statement explaining why the evidence was not previously 
submitted to the QIC or a prior decision-maker is not included with the 
evidence, the evidence will not be considered.
    (d) When this section does not apply. The requirements of this 
section do not apply to oral testimony given at a hearing, or to 
evidence submitted by an unrepresented beneficiary.
0
31. Section 405.1020 is amended by--
0
a. Revising paragraphs (b), (c), (d), and (e)(3) and (4).
0
b. Adding paragraphs (g)(3)(vii) and (viii).
0
c. Revising paragraphs (h), (i) paragraph heading, and (i)(1), (2), 
(4), and (5).
0
d. Adding paragraph (j).
    The revisions and additions read as follows:


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

* * * * *
    (b) Determining how appearances are made. (1) Appearances by 
unrepresented beneficiaries. The ALJ will direct that the appearance of 
an unrepresented beneficiary who filed a request for hearing be 
conducted by video-teleconferencing (VTC) if the ALJ finds that VTC 
technology is available to conduct the appearance, unless the ALJ find 
good cause for an in-person appearance.
    (i) The ALJ may also offer to conduct a hearing by telephone if the 
request for hearing or administrative record suggests that a telephone 
hearing may be more convenient for the unrepresented beneficiary.
    (ii) The ALJ, with the concurrence of the Chief ALJ or designee, 
may find good cause that an in-person hearing should be conducted if--
    (A) VTC or telephone technology is not available; or
    (B) Special or extraordinary circumstances exist.
    (2) Appearances by individuals other than unrepresented 
beneficiaries. The ALJ will direct that the appearance of an 
individual, other than an unrepresented beneficiary who filed a request 
for hearing, be conducted by telephone, unless the ALJ finds good cause 
for an appearance by other means.
    (i) The ALJ may find good cause for an appearance by VTC if he or 
she determines that VTC is necessary to examine the facts or issues 
involved in the appeal.
    (ii) The ALJ, with the concurrence of the Chief ALJ or designee, 
also may find

[[Page 43866]]

good cause that an in-person hearing should be conducted if--
    (A) VTC and telephone technology are not available; or
    (B) Special or extraordinary circumstances exist.
    (c) Notice of hearing. (1) A notice of hearing is sent to all 
parties that filed an appeal or participated in the reconsideration, 
any party who was found liable for the services at issue subsequent to 
the initial determination or may be found liable based on a review of 
the record, the QIC that issued the reconsideration, and CMS or a 
contractor that the ALJ believes would be beneficial to the hearing, 
advising them of the proposed time and place of the hearing.
    (2) The notice of hearing will require all parties to the ALJ 
hearing to reply to the notice by:
    (i) Acknowledging whether they plan to attend the hearing at the 
time and place proposed in the notice of hearing, or whether they 
object to the proposed time and/or place of the hearing;
    (ii) If the party or representative is an entity or organization, 
specifying who from the entity or organization plans to attend the 
hearing, if anyone, and in what capacity, in addition to the individual 
who filed the request for hearing; and
    (iii) Listing the witnesses who will be providing testimony at the 
hearing.
    (3) The notice of hearing will require CMS or a contractor that 
wishes to attend the hearing as a participant to reply to the notice 
by:
    (i) Acknowledging whether it plans to attend the hearing at the 
time and place proposed in the notice of hearing; and
    (ii) Specifying who from the entity plans to attend the hearing.
    (d) A party's right to waive a hearing. A party may also waive the 
right to a hearing and request a decision based on the written evidence 
in the record in accordance with Sec.  405.1038(b). As provided in 
Sec.  405.1000, an ALJ may require the parties to attend a hearing if 
it is necessary to decide the case. If an ALJ determines that it is 
necessary to obtain testimony from a non-party, he or she may still 
hold a hearing to obtain that testimony, even if all of the parties 
have waived the right to appear. In those cases, the ALJ will give the 
parties the opportunity to appear when the testimony is given but may 
hold the hearing even if none of the parties decide to appear.
    (e) * * *
    (3) The request must be in writing, except that a party may orally 
request that a hearing be rescheduled in an emergency circumstance the 
day prior to or day of the hearing. The ALJ must document all oral 
requests for a rescheduled hearing in writing and maintain the 
documentation in the administrative record.
    (4) The ALJ may change the time or place of the hearing if the 
party has good cause.
* * * * *
    (g) * * *
    (3) * * *
    (vii) The party or representative has a prior commitment that 
cannot be changed without significant expense.
    (viii) The party or representative asserts that he or she did not 
receive the notice of hearing and is unable to appear at the scheduled 
time and place.
    (h) Effect of rescheduling hearing. If a hearing is postponed at 
the request of the appellant for any of the above reasons, the time 
between the originally scheduled hearing date and the new hearing date 
is not counted toward the adjudication period specified in Sec.  
405.1016.
    (i) A party's request for an in-person or VTC hearing. (1) If an 
unrepresented beneficiary who filed the request for hearing objects to 
a VTC hearing or to the ALJ's offer to conduct a hearing by telephone, 
or if a party other than an unrepresented beneficiary who filed the 
request for hearing objects to a telephone or VTC hearing, the party 
must notify the ALJ at the earliest possible opportunity before the 
time set for the hearing and request a VTC or an in-person hearing.
    (2) The party must state the reason for the objection and state the 
time and/or place he or she wants an in-person or VTC hearing to be 
held.
* * * * *
    (4) When a party's request for an in-person or VTC hearing as 
specified under paragraph (i)(1) of this section is granted and an 
adjudication time frame applies in accordance with Sec.  405.1016, the 
ALJ issues a decision, dismissal, or remand to the QIC within the 
adjudication time frame specified in Sec.  405.1016 (including any 
applicable extensions provided in this subpart) unless the party 
requesting the hearing agrees to waive such adjudication time frame in 
writing.
    (5) The ALJ may grant the request, with the concurrence of the 
Chief ALJ or designee, upon a finding of good cause and will reschedule 
the hearing for a time and place when the party may appear in person or 
by VTC before the ALJ.
    (j) Amended notice of hearing. If the ALJ changes or will change 
the time and/or place of the hearing, an amended notice of hearing must 
be sent to all of the parties who were sent a copy of the notice of 
hearing and CMS or its contractors that elected to be a participant or 
party to the hearing in accordance with Sec.  405.1022(a).
0
32. Section 405.1022 is revised to read as follows:


Sec.  405.1022  Notice of a hearing before an ALJ.

    (a) Issuing the notice. After the ALJ sets the time and place of 
the hearing, notice of the hearing will be mailed or otherwise 
transmitted in accordance with OMHA procedures to the parties and other 
potential participants, as provided in Sec.  405.1020(c) at their last 
known address, or given by personal service, except to a party or 
potential participant who indicates in writing that it does not wish to 
receive this notice. The notice is mailed, transmitted, or served at 
least 20 calendar days before the hearing unless the recipient agrees 
in writing to the notice being mailed, transmitted, or served fewer 
than 20 calendar days before the hearing.
    (b) Notice information. (1) The notice of hearing contains--
    (i) A statement that the issues before the ALJ include all of the 
issues brought out in the initial determination, redetermination, or 
reconsideration that were not decided entirely in a party's favor, for 
the claims specified in the request for hearing; and
    (ii) A statement of any specific new issues the ALJ will consider 
in accordance with Sec.  405.1032.
    (2) The notice will inform the parties that they may designate a 
person to represent them during the proceedings.
    (3) The notice must include an explanation of the procedures for 
requesting a change in the time or place of the hearing, a reminder 
that the ALJ may dismiss the hearing request if the appellant fails to 
appear at the scheduled hearing without good cause, and other 
information about the scheduling and conduct of the hearing.
    (4) The appellant will also be told if his or her appearance or 
that of any other party or witness is scheduled by VTC, telephone, or 
in person. If the ALJ has scheduled the appellant or other party to 
appear at the hearing by VTC, the notice of hearing will advise that 
the scheduled place for the hearing is a VTC site and explain what it 
means to appear at the hearing by VTC.
    (5) The notice advises the appellant or other parties that if they 
object to appearing by VTC or telephone, and wish instead to have their 
hearing at a time and place where they may appear in person before the 
ALJ, they must follow the procedures set forth at Sec.  405.1020(i) for 
notifying the ALJ of

[[Page 43867]]

their objections and for requesting an in-person hearing.
    (c) Acknowledging the notice of hearing. (1) If the appellant, any 
other party to the reconsideration to whom the notice of hearing was 
sent, or their representative does not acknowledge receipt of the 
notice of hearing, OMHA attempts to contact the party for an 
explanation.
    (2) If the party states that he or she did not receive the notice 
of hearing, a copy of the notice is sent to him or her by certified 
mail or other means requested by the party and in accordance with OMHA 
procedures.
    (3) The party may request that the ALJ reschedule the hearing in 
accordance with Sec.  405.1020(e).
0
33. Section 405.1024 is amended by revising paragraphs (b) and (c) to 
read as follows:


Sec.  405.1024  Objections to the issues.

* * * * *
    (b) The party must state the reasons for his or her objections and 
send a copy of the objections to all other parties who were sent a copy 
of the notice of hearing, and CMS or a contractor that elected to be a 
party to the hearing.
    (c) The ALJ makes a decision on the objections either in writing, 
at a prehearing conference, or at the hearing.
0
34. Section 405.1026 is revised to read as follows:


Sec.  405.1026  Disqualification of the ALJ or attorney adjudicator.

    (a) An ALJ or attorney adjudicator cannot adjudicate an appeal if 
he or she is prejudiced or partial to any party or has any interest in 
the matter pending for decision.
    (b) If a party objects to the ALJ or attorney adjudicator assigned 
to adjudicate the appeal, the party must notify the ALJ within 10 
calendar days of the date of the notice of hearing if a hearing is 
scheduled, or the ALJ or attorney adjudicator at any time before a 
decision, dismissal order, or remand order is issued if no hearing is 
scheduled. The ALJ or attorney adjudicator considers the party's 
objections and decides whether to proceed with the appeal or withdraw.
    (c) If the ALJ or attorney adjudicator withdraws, another ALJ or 
attorney adjudicator will be assigned to adjudicate the appeal. If the 
ALJ or attorney adjudicator does not withdraw, the party may, after the 
ALJ or attorney adjudicator has issued an action in the case, present 
his or her objections to the Council in accordance with Sec.  405.1100 
through Sec.  405.1130. The Council will then consider whether the 
decision or dismissal should be revised or if applicable, a new hearing 
held before another ALJ. If the case is escalated to the Council after 
a hearing is held but before the ALJ issues a decision, the Council 
considers the reasons the party objected to the ALJ during its review 
of the case and, if the Council deems it necessary, may remand the case 
to another ALJ for a hearing and decision.
    (d) If the party objects to the ALJ or attorney adjudicator and the 
ALJ or attorney adjudicator subsequently withdraws from the appeal, any 
adjudication time frame that applies to the appeal in accordance with 
Sec.  405.1016 is extended by 14 calendar days.
0
35. Section 405.1028 is revised to read as follows:


Sec.  405.1028  Review of evidence submitted by parties.

    (a) New evidence--(1) Examination of any new evidence. After a 
hearing is requested but before a hearing is held by an ALJ or a 
decision is issued if no hearing is held, the ALJ or attorney 
adjudicator will examine any new evidence submitted in accordance with 
Sec.  405.1018, by a provider, supplier, or beneficiary represented by 
a provider or supplier to determine whether the provider, supplier, or 
beneficiary represented by a provider or supplier had good cause for 
submitting the evidence for the first time at the OMHA level.
    (2) Determining if good cause exists. An ALJ or attorney 
adjudicator finds good cause when--
    (i) The new evidence is, in the opinion of the ALJ or attorney 
adjudicator, material to an issue addressed in the QIC's 
reconsideration and that issue was not identified as a material issue 
prior to the QIC's reconsideration;
    (ii) The new evidence is, in the opinion of the ALJ, material to a 
new issue identified in accordance with Sec.  405.1032(b)(1);
    (iii) The party was unable to obtain the evidence before the QIC 
issued its reconsideration and submits evidence that, in the opinion of 
the ALJ or attorney adjudicator, demonstrates the party made reasonable 
attempts to obtain the evidence before the QIC issued its 
reconsideration;
    (iv) The party asserts that the evidence was submitted to the QIC 
or another contractor and submits evidence that, in the opinion of the 
ALJ or attorney adjudicator, demonstrates the new evidence was 
submitted to the QIC or another contractor before the QIC issued the 
reconsideration; or
    (v) In circumstances not addressed in paragraphs (a)(2)(i) through 
(iv) of this section, the ALJ or attorney adjudicator determines that 
the party has demonstrated that it could not have obtained the evidence 
before the QIC issued its reconsideration.
    (3) If good cause does not exist. If the ALJ or attorney 
adjudicator determines that there was not good cause for submitting the 
evidence for the first time at the OMHA level, the ALJ or attorney 
adjudicator must exclude the evidence from the proceeding and may not 
consider it in reaching a decision.
    (4) Notification to parties. If a hearing is conducted, as soon as 
possible, but no later than the start of the hearing, the ALJ must 
notify all parties and participants who responded to the notice of 
hearing whether the evidence will be considered or is excluded from 
consideration.
    (b) Duplicative evidence. The ALJ or attorney adjudicator may 
exclude from consideration any evidence submitted by a party at the 
OMHA level that is duplicative of evidence already in the record 
forwarded to OMHA.
0
36. Section 405.1030 is revised to read as follows:


Sec.  405.1030  ALJ hearing procedures.

    (a) General rule. A hearing is open to the parties and to other 
persons the ALJ considers necessary and proper.
    (b) At the hearing. (1) At the hearing, the ALJ fully examines the 
issues, questions the parties and other witnesses, and may accept 
evidence that is material to the issues consistent with Sec. Sec.  
405.1018 and 405.1028.
    (2) The ALJ may limit testimony and/or argument at the hearing that 
are not relevant to an issue before the ALJ, or that address an issue 
before the ALJ for which the ALJ determines he or she has sufficient 
information or on which the ALJ has already ruled. The ALJ may, but is 
not required to, provide the party or representative with an 
opportunity to submit additional written statements and affidavits on 
the matter, in lieu of testimony and/or argument at the hearing. The 
written statements and affidavits must be submitted within the time 
frame designated by the ALJ.
    (3) If the ALJ determines that a party or party's representative is 
uncooperative, disruptive to the hearing, or abusive during the course 
of the hearing, the ALJ may excuse the party or representative from the 
hearing and continue with the hearing to provide the other parties and 
participants with an opportunity to offer testimony and/or argument. If 
a party or representative was excused from the hearing, the ALJ will 
provide the party or representative with an opportunity to submit 
written statements and affidavits

[[Page 43868]]

in lieu of testimony and/or argument at the hearing, and the party or 
representative may request a recording of the hearing in accordance 
with Sec.  405.1042 and respond in writing to any statements made by 
other parties or participants and/or testimony of the witnesses at the 
hearing. The written statements and affidavits must be submitted within 
the time frame designated by the ALJ.
    (c) Missing evidence. The ALJ may also stop the hearing temporarily 
and continue it at a later date if he or she believes that there is 
material evidence missing at the hearing. If the missing evidence is in 
the possession of the appellant, and the appellant is a provider, 
supplier, or a beneficiary represented by a provider or supplier, the 
ALJ must determine if the appellant had good cause in accordance with 
Sec.  405.1028 for not producing the evidence earlier.
    (d) Effect of New evidence on adjudication period. If an appellant, 
other than an unrepresented beneficiary, submits evidence pursuant to 
paragraph (b) or (c) of this section, and an adjudication period 
applies to the appeal, the adjudication period specified in Sec.  
405.1016 is extended in accordance with Sec.  405.1018(b).
    (e) Continued hearing. (1) A hearing may be continued to a later 
date. Notice of the continued hearing must be sent in accordance with 
Sec.  405.1022, except that a waiver of notice of the hearing may be 
made in writing or on the record, and the notice is sent to the parties 
and participants who attended the hearing, and any additional parties 
or potential parties or participants the ALJ determines are 
appropriate.
    (2) If the appellant requests the continuance and an adjudication 
period applies to the appeal in accordance with Sec.  405.1016, the 
adjudication period is extended by the period between the initial 
hearing date and the continued hearing date.
    (f) Supplemental hearing. (1) The ALJ may conduct a supplemental 
hearing at any time before he or she mails a notice of the decision in 
order to receive new and material evidence, obtain additional 
testimony, or address a procedural matter. The ALJ determines whether a 
supplemental hearing is necessary and if one is held, the scope of the 
hearing, including when evidence is presented and what issues are 
discussed. Notice of the supplemental hearing must be sent in 
accordance with Sec.  405.1022, except that the notice is sent to the 
parties and participants who attended the hearing, and any additional 
parties or potential parties or participants the ALJ determines are 
appropriate.
    (2) If the appellant requests the supplemental hearing and an 
adjudication period applies to the appeal in accordance with Sec.  
405.1016, the adjudication period is extended by the period between the 
initial hearing date and the supplemental hearing date.
0
37. Section 405.1032 is revised to read as follows:


Sec.  405.1032  Issues before an ALJ or attorney adjudicator.

    (a) General rule. The issues before the ALJ or attorney adjudicator 
include all the issues for the claims or appealed matter specified in 
the request for hearing that were brought out in the initial 
determination, redetermination, or reconsideration that were not 
decided entirely in a party's favor. (For purposes of this provision, 
the term ``party'' does not include a representative of CMS or one of 
its contractors that may be participating in the hearing.)
    (b) New issues--(1) When a new issue may be considered. A new issue 
may include issues resulting from the participation of CMS or its 
contractor at the OMHA level of adjudication and from any evidence and 
position papers submitted by CMS or its contractor for the first time 
to the ALJ. The ALJ or any party may raise a new issue relating to a 
claim or appealed matter specified in the request for hearing; however, 
the ALJ may only consider a new issue, including a favorable portion of 
a determination on a claim or appealed matter specified in the request 
for hearing, if its resolution could have a material impact on the 
claim or appealed matter and--
    (i) There is new and material evidence that was not available or 
known at the time of the determination and that may result in a 
different conclusion; or
    (ii) The evidence that was considered in making the determination 
clearly shows on its face that an obvious error was made at the time of 
the determination.
    (2) Notice of the new issue. The ALJ may consider a new issue at 
the hearing if he or she notifies the parties that were or will be sent 
the notice of hearing about the new issue before the start of the 
hearing.
    (3) Opportunity to submit evidence. If notice of the new issue is 
sent after the notice of hearing, the parties will have at least 10 
calendar days after receiving notice of the new issue to submit 
evidence regarding the issue, and without affecting any applicable 
adjudication period. If a hearing is conducted before the time to 
submit evidence regarding the issue expires, the record will remain 
open until the opportunity to submit evidence expires.
    (c) Adding claims to a pending appeal. (1) Claims that were not 
specified in a request for hearing may only be added to a pending 
appeal if the claims were adjudicated in the same reconsideration that 
is appealed, and the period to request an ALJ hearing for that 
reconsideration has not expired, or an ALJ or attorney adjudicator 
extends the time to request an ALJ hearing on those claims in 
accordance with Sec.  405.1014(e).
    (2) Before a claim may be added to a pending appeal, the appellant 
must submit evidence that demonstrates the information that constitutes 
a complete request for hearing in accordance with Sec.  405.1014(b) and 
other materials related to the claim that the appellant seeks to add to 
the pending appeal were sent to the other parties to the claim in 
accordance with Sec.  405.1014(d).
    (d) Appeals involving statistical sampling and extrapolations. (1) 
Generally. If the appellant does not assert the reasons the appellant 
disagrees with how a statistical sample and/or extrapolation was 
conducted in the request for hearing, in accordance with Sec.  
405.1014(a)(3)(iii), issues related to how the statistical sample and 
extrapolation were conducted shall not be considered or decided.
    (2) Consideration of sample claims. If a party asserts a 
disagreement with how a statistical sample and/or extrapolation was 
conducted in the request for hearing, in accordance with Sec.  
405.1014(a)(3)(iii), paragraphs (a) through (c) of this section apply 
to the adjudication of the sample claims but, in deciding issues 
related to how a statistical sample and/or extrapolation was conducted 
the ALJ or attorney adjudicator must base his or her decision on a 
review of the entire sample to the extent appropriate to decide the 
issue.
0
38. Section 405.1034 is revised to read as follows:


Sec.  405.1034  Requesting information from the QIC.

    (a) If an ALJ or attorney adjudicator believes that the written 
record is missing information that is essential to resolving the issues 
on appeal and that information can be provided only by CMS or its 
contractors, the information may be requested from the QIC that 
conducted the reconsideration or its successor.
    (1) Official copies of redeterminations and reconsiderations that 
were conducted on the appealed claims can be provided only by CMS or 
its contractors.
    (2) ``Can be provided only by CMS or its contractors'' means the 
information

[[Page 43869]]

is not publicly available, is not in the possession of, and cannot be 
requested and obtained by one of the parties. Information that is 
publicly available is information that is available to the general 
public via the Internet or in a printed publication. Information that 
is publicly available includes, but is not limited to, information 
available on a CMS or contractor Web site or information in an official 
CMS or DHHS publication (including, but not limited to, provisions of 
NCDs or LCDs, procedure code or modifier descriptions, fee schedule 
data, and contractor operating manual instructions).
    (b) The ALJ or attorney adjudicator retains jurisdiction of the 
case, and the case remains pending at OMHA.
    (c) The QIC has 15 calendar days after receiving the request for 
information to furnish the information or otherwise respond to the 
information request directly or through CMS or another contractor.
    (d) If an adjudication period applies to the appeal in accordance 
with Sec.  405.1016, the adjudication period is extended by the period 
between the date of the request for information and the date the QIC 
responds to the request or 20 calendar days after the date of the 
request, whichever occurs first.


Sec.  405.1036  [Amended]

0
39. Section 405.1036 is amended by--
0
a. Amending paragraph (b)(1) by removing the phrase ``send the ALJ'' 
and adding ``submit to OMHA'' in its place.
0
b. Removing paragraph (d).
0
c. Redesignating paragraph (g) as new paragraph (d).
0
d. Amending paragraphs (f)(5)(i), (ii), (iii), (iv), (v), and (vi) by 
removing the term ``MAC'' each time it appears and adding ``Council'' 
in its place.
0
e. Amending paragraphs (f)(5)(i) and (ii) by removing the term 
``MAC's'' and adding ``Council's'' in its place.
0
f. Amending paragraph (f)(5)(i) by removing the phrase ``specified in 
Sec.  405.1102, Sec.  405.1104, or Sec.  405.1110'' and adding 
``specified in Sec.  405.1016(e) and (f), Sec.  405.1102, or Sec.  
405.1110'' in its place.
0
g. Amending paragraph (f)(5)(ii) by removing the phrase ``discovery 
ruling'' each time it appears and adding ``subpoena ruling'' in its 
place.
0
40. Section 405.1037 is amended by--
0
a. Revising paragraph (a)(1).
0
b. Amending paragraph (e)(1) by removing the phrase ``specified in 
Sec.  405.1100, Sec.  405.1102, Sec.  405.1104, or Sec.  405.1110'' and 
adding ``specified in Sec.  405.1016(e) and (f), Sec.  405.1100, Sec.  
405.1102, or Sec.  405.1110'' in its place.
0
c. Amending paragraphs (e)(1), (e)(2) introductory text, (e)(2)(i), 
(ii), (iii), (iv), and (v) by removing the term ``MAC'' each time it 
appears and adding ``Council'' in its place.
0
d. Amending paragraphs (e)(1) and (e)(2)(i) by removing the term 
``MAC's'' and adding ``Council's'' in its place.
0
e. Revising paragraph (f).
    The revisions read as follows:


Sec.  405.1037  Discovery.

    (a) * * *
    (1) Discovery is permissible only when CMS or its contractor elects 
to be a party to an ALJ hearing, in accordance with Sec.  405.1012.
* * * * *
    (f) Adjudication period. If an adjudication period applies to the 
appeal in accordance with Sec.  405.1016, and a party requests 
discovery from another party to the hearing, the adjudication period is 
extended for the duration of discovery, from the date a discovery 
request is granted until the date specified for ending discovery.
0
41. Section 405.1038 is revised to read as follows:


Sec.  405.1038  Deciding a case without a hearing before an ALJ.

    (a) Decision fully favorable. If the evidence in the administrative 
record supports a finding fully in favor of the appellant(s) on every 
issue and no other party to the appeal is liable for claims at issue, 
an ALJ or attorney adjudicator may issue a decision without giving the 
parties prior notice and without an ALJ conducting a hearing, unless 
CMS or a contractor has elected to be a party to the hearing in 
accordance with Sec.  405.1012. The notice of the decision informs the 
parties that they have the right to a hearing and a right to examine 
the evidence on which the decision is based.
    (b) Parties do not wish to appear. (1) An ALJ or attorney 
adjudicator may decide a case on the record and without an ALJ 
conducting a hearing if--
    (i) All the parties who would be sent a notice of hearing in 
accordance with Sec.  405.1020(c) indicate in writing that they do not 
wish to appear before an ALJ at a hearing, including a hearing 
conducted by telephone or video-teleconferencing, if available; or
    (ii) The appellant lives outside the United States and does not 
inform OMHA that he or she wants to appear at a hearing before an ALJ, 
and there are no other parties who would be sent a notice of hearing in 
accordance with Sec.  405.1020(c) and who wish to appear.
    (2) When a hearing is not held, the decision of the ALJ or attorney 
adjudicator must refer to the evidence in the record on which the 
decision was based.
    (c) Stipulated decision. If CMS or one of its contractors submits a 
written statement or makes an oral statement at a hearing indicating 
the item or service should be covered or payment may be made, an ALJ or 
attorney adjudicator may issue a stipulated decision finding in favor 
of the appellant or other liable parties on the basis of the statement, 
and without making findings of fact, conclusions of law, or further 
explaining the reasons for the decision.
0
42. Section 405.1040 is revised to read as follows:


Sec.  405.1040  Prehearing and posthearing conferences.

    (a) The ALJ may decide on his or her own, or at the request of any 
party to the hearing, to hold a prehearing or posthearing conference to 
facilitate the hearing or the hearing decision.
    (b) The ALJ informs the parties who will be or were sent a notice 
of hearing in accordance with Sec.  405.1020(c), and CMS or a 
contractor that has elected to be a participant in the proceedings or 
party to the hearing at the time the notice of conference is sent, of 
the time, place, and purpose of the conference at least 7 calendar days 
before the conference date, unless a party indicates in writing that it 
does not wish to receive a written notice of the conference.
    (c) At the conference--
    (1) The ALJ or an OMHA attorney designated by the ALJ conducts the 
conference, but only the ALJ conducting a conference may consider 
matters in addition to those stated in the conference notice if the 
parties consent to consideration of the additional matters in writing.
    (2) An audio recording of the conference is made.
    (d) The ALJ issues an order to all parties and participants who 
attended the conference stating all agreements and actions resulting 
from the conference. If a party does not object within 10 calendar days 
of receiving the order, or any additional time granted by the ALJ, the 
agreements and actions become part of the administrative record and are 
binding on all parties.
0
43. Section 405.1042 is revised to read as follows:


Sec.  405.1042  The administrative record.

    (a) Creating the record. (1) OMHA makes a complete record of the 
evidence and administrative proceedings on the appealed matter, 
including any prehearing and posthearing conferences, and hearing 
proceedings that were conducted.
    (2) The record will include marked as exhibits, the appealed 
determinations,

[[Page 43870]]

and documents and other evidence used in making the appealed 
determinations and the ALJ's or attorney adjudicator's decision, 
including, but not limited to, claims, medical records, written 
statements, certificates, reports, affidavits, and any other evidence 
the ALJ or attorney adjudicator admits. The record will also include 
any evidence excluded or not considered by the ALJ or attorney 
adjudicator, including, but not limited to, new evidence submitted by a 
provider or supplier, or beneficiary represented by a provider or 
supplier, for which no good cause was established, and duplicative 
evidence submitted by a party.
    (3) A party may request and review a copy of the record prior to or 
at the hearing, or, if a hearing is not held, at any time before the 
notice of decision is issued.
    (4) If a request for review is filed or the case is escalated to 
the Council, the complete record, including any prehearing and 
posthearing conference and hearing recordings, is forwarded to the 
Council.
    (5) A typed transcription of the hearing is prepared if a party 
seeks judicial review of the case in a Federal district court within 
the stated time period and all other jurisdictional criteria are met, 
unless, upon the Secretary's motion prior to the filing of an answer, 
the court remands the case.
    (b) Requesting and receiving copies of the record. (1) While an 
appeal is pending at OMHA, a party may request and receive a copy of 
all or part of the record from OMHA, including any index of the 
administrative record, documentary evidence, and a copy of the audio 
recording of the oral proceedings. The party may be asked to pay the 
costs of providing these items.
    (2) If a party requests a copy of all or part of the record from 
OMHA or the ALJ or attorney adjudicator and an opportunity to comment 
on the record, any adjudication period that applies in accordance with 
Sec.  405.1016 is extended by the time beginning with the receipt of 
the request through the expiration of the time granted for the party's 
response.
    (3) If a party requests a copy of all or part of the record and the 
record, including any audio recordings, contains information pertaining 
to an individual that the requesting party is not entitled to receive, 
such as personally identifiable information or protected health 
information, such portions of the record will not be furnished unless 
the requesting party obtains consent from the individual.
0
44. Section 405.1044 is revised to read as follows:


Sec.  405.1044  Consolidated proceedings.

    (a) Consolidated hearing. (1) A consolidated hearing may be held if 
one or more of the issues to be considered at the hearing are the same 
issues that are involved in one or more other appeals pending before 
the same ALJ.
    (2) It is within the discretion of the ALJ to grant or deny an 
appellant's request for consolidation. In considering an appellant's 
request, the ALJ may consider factors such as whether the claims at 
issue may be more efficiently decided if the appeals are consolidated 
for hearing. In considering the appellant's request for consolidation, 
the ALJ must take into account any adjudication deadlines for each 
appeal and may require an appellant to waive the adjudication deadline 
associated with one or more appeals if consolidation otherwise prevents 
the ALJ from deciding all of the appeals at issue within their 
respective deadlines.
    (3) The ALJ may also propose on his or her own motion to 
consolidate two or more appeals in one hearing for administrative 
efficiency, but may not require an appellant to waive the adjudication 
deadline for any of the consolidated cases.
    (4) Notice of a consolidated hearing must be included in the notice 
of hearing issued in accordance with Sec. Sec.  405.1020 and 405.1022.
    (b) Consolidated or separate decision and record. (1) If the ALJ 
decides to hold a consolidated hearing, he or she may make either--
    (i) A consolidated decision and record; or
    (ii) A separate decision and record on each appeal.
    (2) If a separate decision and record on each appeal is made, the 
ALJ is responsible for making sure that any evidence that is common to 
all appeals and material to the common issue to be decided, and audio 
recordings of any conferences that were conducted and the consolidated 
hearing are included in each individual administrative record, as 
applicable.
    (3) If a hearing will not be conducted for multiple appeals that 
are before the same ALJ or attorney adjudicator, and the appeals 
involve one or more of the same issues, the ALJ or attorney adjudicator 
may make a consolidated decision and record at the request of the 
appellant or on the ALJ's or attorney adjudicator's own motion.
    (c) Limitation on consolidated proceedings. Consolidated 
proceedings may only be conducted for appeals filed by the same 
appellant, unless multiple appellants aggregated claims to meet the 
amount in controversy requirement in accordance with Sec.  405.1006 and 
the beneficiaries whose claims are at issue have all authorized 
disclosure of their protected information to the other parties and any 
participants.
0
45. Section 405.1046 is revised to read as follows:


Sec.  405.1046  Notice of an ALJ or attorney adjudicator decision.

    (a) Decisions on requests for hearing--(1) General rule. Unless the 
ALJ or attorney adjudicator dismisses or remands the request for 
hearing, the ALJ or attorney adjudicator will issue a written decision 
that gives the findings of fact, conclusions of law, and the reasons 
for the decision. The decision must be based on evidence offered at the 
hearing or otherwise admitted into the record, and shall include 
independent findings and conclusions. OMHA mails or otherwise transmits 
a copy of the decision to all the parties at their last known address 
and the QIC that issued the reconsideration or from which the appeal 
was escalated. For overpayment cases involving multiple beneficiaries, 
where there is no beneficiary liability, the ALJ or attorney 
adjudicator may choose to send written notice only to the appellant. In 
the event a payment will be made to a provider or supplier in 
conjunction with the ALJ's or attorney adjudicator's decision, the 
contractor must also issue a revised electronic or paper remittance 
advice to that provider or supplier.
    (2) Content of the notice. The decision must be written in a manner 
calculated to be understood by a beneficiary and must include--
    (i) The specific reasons for the determination, including, to the 
extent appropriate, a summary of any clinical or scientific evidence 
used in making the determination;
    (ii) For any new evidence that was submitted for the first time at 
the OMHA level and subject to a good cause determination pursuant to 
Sec.  405.1028, a discussion of the new evidence and the good cause 
determination that was made.
    (iii) The procedures for obtaining additional information 
concerning the decision; and
    (iv) Notification of the right to appeal the decision to the 
Council, including instructions on how to initiate an appeal under this 
section.
    (3) Limitation on decision. When the amount of payment for an item 
or service is an issue before the ALJ or attorney adjudicator, the ALJ 
or attorney adjudicator may make a finding as to the amount of payment 
due. If the ALJ or attorney adjudicator makes a finding concerning 
payment when the amount of payment was not an issue before the

[[Page 43871]]

ALJ or attorney adjudicator, the contractor may independently determine 
the payment amount. In either of the aforementioned situations, an 
ALJ's or attorney adjudicator's decision is not binding on the 
contractor for purposes of determining the amount of payment due. The 
amount of payment determined by the contractor in effectuating the 
ALJ's or attorney adjudicator's decision is a new initial determination 
under Sec.  405.924.
    (b) Decisions on requests for review of a QIC dismissal--(1) 
General rule. Unless the ALJ or attorney adjudicator dismisses the 
request for review of a QIC dismissal, or the QIC's dismissal is 
vacated and remanded, the ALJ or attorney adjudicator will issue a 
written decision affirming the QIC's dismissal. OMHA mails or otherwise 
transmits a copy of the decision to all the parties that received a 
copy of the QIC's dismissal.
    (2) Content of the notice. The decision must be written in a manner 
calculated to be understood by a beneficiary and must include--
    (i) The specific reasons for the determination, including a summary 
of the evidence considered and applicable authorities;
    (ii) The procedures for obtaining additional information concerning 
the decision; and
    (iii) Notification that the decision is binding and is not subject 
to further review, unless reopened and revised by the ALJ or attorney 
adjudicator.
    (c) Recommended decision. An ALJ or attorney adjudicator issues a 
recommended decision if he or she is directed to do so in the Council's 
remand order. An ALJ or attorney adjudicator may not issue a 
recommended decision on his or her own motion. The ALJ or attorney 
adjudicator mails a copy of the recommended decision to all the parties 
at their last known address.
0
46. Section 405.1048 is revised to read as follows:


Sec.  405.1048  The effect of an ALJ's or attorney adjudicator's 
decision.

    (a) The decision of the ALJ or attorney adjudicator on a request 
for hearing is binding on all parties unless--
    (1) A party requests a review of the decision by the Council within 
the stated time period or the Council reviews the decision issued by an 
ALJ or attorney adjudicator under the procedures set forth in Sec.  
405.1110, and the Council issues a final decision or remand order or 
the appeal is escalated to Federal district court under the provisions 
at Sec.  405.1132 and the Federal district court issues a decision.
    (2) The decision is reopened and revised by an ALJ or attorney 
adjudicator or the Council under the procedures explained in Sec.  
405.980;
    (3) The expedited access to judicial review process at Sec.  
405.990 is used;
    (4) The ALJ's or attorney adjudicator's decision is a recommended 
decision directed to the Council and the Council issues a decision; or
    (5) In a case remanded by a Federal district court, the Council 
assumes jurisdiction under the procedures in Sec.  405.1138 and the 
Council issues a decision.
    (b) The decision of the ALJ or attorney adjudicator on a request 
for review of a QIC dismissal is binding on all parties unless the 
decision is reopened and revised by the ALJ or attorney adjudicator 
under the procedures in Sec.  405.980.


Sec.  405.1050  [Amended]

0
47. Section 405.1050 is amended by--
0
a. Amending the section heading by removing the phrase ``an ALJ'' and 
adding ``OMHA'' in its place.
0
b. Amending the text of the section by removing the phrase ``pending 
before an ALJ'' and adding ``pending before OMHA'' in its place, and by 
removing the term ``the ALJ'' and adding ``OMHA'' in its place.
0
c. Amending the section heading and the text of the section by removing 
the term ``MAC'' each time it appears and adding ``Council'' in its 
place.
0
48. Section 405.1052 is revised to read as follows:


Sec.  405.1052  Dismissal of a request for a hearing before an ALJ or 
request for review of a QIC dismissal.

    (a) Dismissal of request for hearing. An ALJ dismisses a request 
for a hearing under any of the following conditions:
    (1) Neither the party that requested the hearing nor the party's 
representative appears at the time and place set for the hearing, if--
    (i) The party was notified before the time set for the hearing that 
the request for hearing might be dismissed for failure to appear, the 
record contains documentation that the party acknowledged the notice of 
hearing, and the party does not contact the ALJ within 10 calendar days 
after the hearing, or does contact the ALJ but the ALJ determines the 
party did not demonstrate good cause for not appearing; or
    (ii) The record does not contain documentation that the party 
acknowledged the notice of hearing, the ALJ sends a notice to the party 
at the last known address asking why the party did not appear, and the 
party does not respond to the ALJ's notice within 10 calendar days 
after receiving the notice or does contact the ALJ but the ALJ 
determines the party did not demonstrate good cause for not appearing.
    (iii) In determining whether good cause exists under paragraphs 
(a)(1)(i) and (ii) of this section, the ALJ considers any physical, 
mental, educational, or linguistic limitations (including any lack of 
facility with the English language), that the party may have.
    (2) The person or entity requesting a hearing has no right to it 
under Sec.  405.1002.
    (3) The party did not request a hearing within the stated time 
period and the ALJ or attorney adjudicator has not found good cause for 
extending the deadline, as provided in Sec.  405.1014(e).
    (4) The beneficiary whose claim is being appealed died while the 
request for hearing is pending and all of the following criteria apply:
    (i) The request for hearing was filed by the beneficiary or the 
beneficiary's representative, and the beneficiary's surviving spouse or 
estate has no remaining financial interest in the case. In deciding 
this issue, the ALJ or attorney adjudicator considers if the surviving 
spouse or estate remains liable for the services that were denied or a 
Medicare contractor held the beneficiary liable for subsequent similar 
services under the limitation of liability provisions based on the 
denial of the services at issue.
    (ii) No other individuals or entities that have a financial 
interest in the case wish to pursue an appeal under Sec.  405.1002.
    (iii) No other individual or entity filed a valid and timely 
request for an ALJ hearing in accordance to Sec.  405.1014.
    (5) The ALJ or attorney adjudicator dismisses a hearing request 
entirely or refuses to consider any one or more of the issues because a 
QIC, an ALJ or attorney adjudicator, or the Council has made a previous 
determination or decision under this subpart about the appellant's 
rights on the same facts and on the same issue(s) or claim(s), and this 
previous determination or decision has become binding by either 
administrative or judicial action.
    (6) The appellant abandons the request for hearing. An ALJ or 
attorney adjudicator may conclude that an appellant has abandoned a 
request for hearing when OMHA attempts to schedule a hearing and is 
unable to contact the appellant after making reasonable efforts to do 
so.
    (7) The appellant's request is not complete in accordance with

[[Page 43872]]

Sec.  405.1014(a)(1) or the appellant did not send a copy of its 
request to the other parties in accordance with Sec.  405.1014(d), 
after the appellant is provided with an opportunity to complete the 
request and/or send a copy of the request to the other parties.
    (b) Dismissal of request for review of a QIC dismissal. An ALJ or 
attorney adjudicator dismisses a request for review of a QIC dismissal 
under any of the following conditions:
    (1) The person or entity requesting a review of a dismissal has no 
right to it under Sec.  405.1004.
    (2) The party did not request a review within the stated time 
period and the ALJ or attorney adjudicator has not found good cause for 
extending the deadline, as provided in Sec.  405.1014(e).
    (3) The beneficiary whose claim is being appealed died while the 
request for review is pending and all of the following criteria apply:
    (i) The request for review was filed by the beneficiary or the 
beneficiary's representative, and the beneficiary's surviving spouse or 
estate has no remaining financial interest in the case. In deciding 
this issue, the ALJ or attorney adjudicator considers if the surviving 
spouse or estate remains liable for the services that were denied or a 
Medicare contractor held the beneficiary liable for subsequent similar 
services under the limitation of liability provisions based on the 
denial of the services at issue.
    (ii) No other individuals or entities that have a financial 
interest in the case wish to pursue an appeal under Sec.  405.1004.
    (iii) No other individual or entity filed a valid and timely 
request for a review of the QIC dismissal in accordance to Sec.  
405.1014.
    (4) The appellant's request is not complete in accordance with 
Sec.  405.1014(a)(1) or the appellant did not send a copy of its 
request to the other parties in accordance with Sec.  405.1014(d), 
after the appellant is provided with an opportunity to complete the 
request and/or send a copy of the request to the other parties.
    (c) Withdrawal of request. At any time before notice of the 
decision, dismissal, or remand is mailed, if only one party requested 
the hearing or review of the QIC dismissal and that party asks to 
withdraw the request, an ALJ or attorney adjudicator may dismiss the 
request for hearing or request for review of a QIC dismissal. This 
request for withdrawal may be submitted in writing, or a request to 
withdraw a request for hearing may be made orally at a hearing before 
the ALJ. The request for withdrawal must include a clear statement that 
the appellant is withdrawing the request for hearing or review of the 
QIC dismissal and does not intend to further proceed with the appeal. 
If an attorney or other legal professional on behalf of a beneficiary 
or other appellant files the request for withdrawal, the ALJ or 
attorney adjudicator may presume that the representative has advised 
the appellant of the consequences of the withdrawal and dismissal.
    (d) Notice of dismissal. OMHA mails or otherwise transmits a 
written notice of the dismissal of the hearing or review request to all 
parties who were sent a copy of the request for hearing or review at 
their last known address. The notice states that there is a right to 
request that the ALJ or attorney adjudicator vacate the dismissal 
action. The appeal will proceed with respect to any other parties who 
filed a valid request for hearing or review regarding the same claim or 
disputed matter.
    (e) Vacating a dismissal. If good and sufficient cause is 
established, the ALJ or attorney adjudicator may vacate his or her 
dismissal of a request for hearing or review within 6 months of the 
date of the notice of dismissal.
0
49. Section 405.1054 is revised to read as follows:


Sec.  405.1054  Effect of dismissal of a request for a hearing or 
request for review of QIC dismissal.

    (a) The dismissal of a request for a hearing is binding, unless it 
is vacated by the Council under Sec.  405.1108(b), or vacated by the 
ALJ or attorney adjudicator under Sec.  405.1052(e).
    (b) The dismissal of a request for review of a QIC dismissal of a 
request for reconsideration is binding and not subject to further 
review unless it is vacated by the ALJ or attorney adjudicator under 
Sec.  405.1052(e).
0
50. Section 405.1056 is added before the undesignated center heading 
``Applicability of Medicare Coverage Policies'' to read as follows:


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

    (a) Missing appeal determination or case record. (1) If an ALJ or 
attorney adjudicator requests an official copy of a missing 
redetermination or reconsideration for an appealed claim in accordance 
with Sec.  405.1034, and the QIC or another contractor does not furnish 
the copy within the time frame specified in Sec.  405.1034, the ALJ or 
attorney adjudicator may issue a remand directing the QIC or other 
contractor to reconstruct the record or, if it is not able to do so, 
initiate a new appeal adjudication.
    (2) If the QIC does not furnish the case file for an appealed 
reconsideration, an ALJ or attorney adjudicator may issue a remand 
directing the QIC to reconstruct the record or, if it is not able to do 
so, initiate a new appeal adjudication.
    (3) If the QIC or another contractor is able to reconstruct the 
record for a remanded case and returns the case to OMHA, the case is no 
longer remanded and the reconsideration is no longer vacated, and any 
adjudication period that applies to the appeal in accordance with Sec.  
405.1016 is extended by the period between the date of the remand and 
the date that case is returned to OMHA.
    (b) No redetermination. If an ALJ or attorney adjudicator finds 
that the QIC issued a reconsideration that addressed coverage or 
payment issues related to the appealed claim and no redetermination of 
the claim was made (if a redetermination was required under this 
subpart) or the request for redetermination was dismissed, the 
reconsideration will be remanded to the QIC, or its successor to re-
adjudicate the request for reconsideration.
    (c) Requested remand--(1) Request contents and timing. At any time 
prior to an ALJ or attorney adjudicator issuing a decision or 
dismissal, the appellant and CMS or one of its contractors may jointly 
request a remand of the appeal to the entity that conducted the 
reconsideration. The request must include the reasons why the appeal 
should be remanded and indicate whether remanding the case will likely 
resolve the matter in dispute.
    (2) Granting the request. An ALJ or attorney adjudicator may grant 
the request and issue a remand if he or she determines that remanding 
the case will likely resolve the matter in dispute.
    (d) Remanding a QIC's dismissal of a request for reconsideration. 
Consistent with Sec.  405.1004(b), an ALJ or attorney adjudicator will 
remand a case to the appropriate QIC if the ALJ or attorney adjudicator 
determines that a QIC's dismissal of a request for reconsideration was 
in error.
    (e) Relationship to local and national coverage determination 
appeals process. (1) An ALJ or attorney adjudicator remands an appeal 
to the QIC that made the reconsideration if the appellant is entitled 
to relief pursuant to Sec. Sec.  426.460(b)(1), 426.488(b), or 
426.560(b)(1) of this chapter.
    (2) Unless the appellant is entitled to relief pursuant to 
Sec. Sec.  426.460(b)(1), 426.488(b), or 426.560(b)(1) of this chapter, 
the ALJ or attorney adjudicator applies the LCD or NCD in place on the 
date the item or service was provided.

[[Page 43873]]

    (f) Notice of a remand. OMHA mails or otherwise transmits a written 
notice of the remand of the request for hearing or request for review 
to all of the parties who were sent a copy of the request at their last 
known address, and CMS or a contractor that elected to be a participant 
in the proceedings or party to the hearing. The notice states that 
there is a right to request that the Chief ALJ or a designee review the 
remand.
    (g) Review of remand. Upon a request by a party or CMS or one of 
its contractors filed within 30 calendar days of receiving a notice of 
remand, the Chief ALJ or designee will review the remand, and if the 
remand is not authorized by this section, vacate the remand order. The 
determination on a request to review a remand order is binding and not 
subject to further review.
0
51. Section 405.1058 is added before the undesignated center heading 
``Applicability of Medicare Coverage Policies'' to read as follows:


Sec.  405.1058  Effect of a remand.

    A remand of a request for hearing or request for review is binding 
unless vacated by the Chief ALJ or a designee in accordance with Sec.  
405.1056(g).


Sec.  405.1060  [Amended]

0
52. Section 405.1060 is amended by--
0
a. Amending paragraph (a)(4) by removing the term ``ALJs'' and adding 
``ALJs and attorney adjudicators'' in its place.
0
b. Amending paragraphs (a)(4), (c) paragraph heading, (c)(1), and 
(c)(2) by removing the term ``MAC'' and adding ``Council'' in its 
place.
0
c. Amending paragraphs (b) paragraph heading, (b)(1), and (b)(2) by 
removing the term ``ALJ'' and adding ``ALJ or attorney adjudicator'' in 
its place.


Sec.  405.1062  [Amended]

0
53. Section 405.1062 is amended by--
0
a. Amending the section heading and paragraphs (a) and (b) by removing 
the term ``MAC'' each time it appears and adding ``Council'' in its 
place.
0
b. Amending the section heading and paragraph (b) by removing the term 
``ALJ'' each time it appears and adding ``ALJ or attorney adjudicator'' 
in its place.
0
c. Amending paragraph (a) by removing the term ``ALJs'' and adding 
``ALJs and attorney adjudicators'' in its place.
0
d. Amending paragraph (c) by removing the phrase ``An ALJ or MAC'' and 
adding ``An ALJ or attorney adjudicator or the Council'' in its place.
0
54. Section 405.1063 is revised to read as follows:


Sec.  405.1063  Applicability of laws, regulations, CMS Rulings, and 
precedential decisions.

    (a) All laws and regulations pertaining to the Medicare and 
Medicaid programs, including, but not limited to Titles XI, XVIII, and 
XIX of the Social Security Act and applicable implementing regulations, 
are binding on ALJs and attorney adjudicators, and the Council.
    (b) CMS Rulings are published under the authority of the 
Administrator, CMS. Consistent with Sec.  401.108 of this chapter, 
rulings are binding on all CMS components, on all HHS components that 
adjudicate matters under the jurisdiction of CMS, and on the Social 
Security Administration to the extent that components of the Social 
Security Administration adjudicate matters under the jurisdiction of 
CMS.
    (c) Precedential decisions designated by the Chair of the 
Departmental Appeals Board in accordance with Sec.  401.109 of this 
chapter, are binding on all CMS components, all HHS components that 
adjudicate matters under the jurisdiction of CMS, and on the Social 
Security Administration to the extent that components of the Social 
Security Administration adjudicate matters under the jurisdiction of 
CMS.


Sec.  405.1064  [Removed]

0
55. Section 405.1064 is removed.
0
56. Section 405.1100 is revised to read as follows:


Sec.  405.1100  Medicare Appeals Council review: General.

    (a) The appellant or any other party to an ALJ's or attorney 
adjudicator's decision or dismissal may request that the Council review 
the ALJ's or attorney adjudicator's decision or dismissal.
    (b) Under circumstances set forth in Sec. Sec.  405.1016 and 
405.1108, the appellant may request that a case be escalated to the 
Council for a decision even if the ALJ or attorney adjudicator has not 
issued a decision, dismissal, or remand in his or her case.
    (c) When the Council reviews an ALJ's or attorney adjudicator's 
decision, it undertakes a de novo review. The Council issues a final 
decision or dismissal order or remands a case to the ALJ or attorney 
adjudicator within 90 calendar days of receipt of the appellant's 
request for review, unless the 90 calendar day period is extended as 
provided in this subpart.
    (d) When deciding an appeal that was escalated from the OMHA level 
to the Council, the Council will issue a final decision or dismissal 
order or remand the case to the OMHA Chief ALJ within 180 calendar days 
of receipt of the appellant's request for escalation, unless the 180 
calendar day period is extended as provided in this subpart.
0
57. Section 405.1102 is revised to read as follows:


Sec.  405.1102  Request for Council review when ALJ or attorney 
adjudicator issues decision or dismissal.

    (a)(1) A party to a decision or dismissal issued by an ALJ or 
attorney adjudicator may request a Council review if the party files a 
written request for a Council review within 60 calendar days after 
receipt of the ALJ's or attorney adjudicator's decision or dismissal.
    (2) For purposes of this section, the date of receipt of the ALJ's 
or attorney adjudicator's decision or dismissal is presumed to be 5 
calendar days after the date of the notice of the decision or 
dismissal, unless there is evidence to the contrary.
    (3) The request is considered as filed on the date it is received 
by the entity specified in the notice of the ALJ's or attorney 
adjudicator's action.
    (b) A party requesting a review may ask that the time for filing a 
request for Council review be extended if--
    (1) The request for an extension of time is in writing;
    (2) It is filed with the Council; and
    (3) It explains why the request for review was not filed within the 
stated time period. If the Council finds that there is good cause for 
missing the deadline, the time period will be extended. To determine 
whether good cause exists, the Council uses the standards outlined at 
Sec.  405.942(b)(2) and (3).
    (c) A party does not have the right to seek Council review of an 
ALJ's or attorney adjudicator's remand to a QIC, affirmation of a QIC's 
dismissal of a request for reconsideration, or dismissal of a request 
for review of a QIC dismissal.
    (d) For purposes of requesting Council review (Sec. Sec.  405.1100 
through 405.1140), unless specifically excepted, the term ``party'', 
includes CMS where CMS has entered into a case as a party according to 
Sec.  405.1012. The term, ``appellant,'' does not include CMS, where 
CMS has entered into a case as a party according to Sec.  405.1012.


Sec.  405.1104  [Removed]

0
58. Section 405.1104 is removed.
0
59. Section 405.1106 is revised to read as follows:


Sec.  405.1106  Where a request for review or escalation may be filed.

    (a) When a request for a Council review is filed after an ALJ or 
attorney adjudicator has issued a decision or dismissal, the request 
for review must

[[Page 43874]]

be filed with the entity specified in the notice of the ALJ's or 
attorney adjudicator's action. The appellant must also send a copy of 
the request for review to the other parties to the ALJ or attorney 
adjudicator decision or dismissal who received notice of the decision 
or dismissal. Failure to copy the other parties tolls the Council's 
adjudication deadline set forth in Sec.  405.1100 until all parties to 
the ALJ or attorney adjudicator decision or dismissal receive notice of 
the request for Council review. If the request for review is timely 
filed with an entity other than the entity specified in the notice of 
the ALJ's or attorney adjudicator's action, the Council 's adjudication 
period to conduct a review begins on the date the request for review is 
received by the entity specified in the notice of the ALJ's or attorney 
adjudicator's action. Upon receipt of a request for review from an 
entity other than the entity specified in the notice of the ALJ's or 
attorney adjudicator's action, the Council sends written notice to the 
appellant of the date of receipt of the request and commencement of the 
adjudication timeframe.
    (b) If an appellant files a request to escalate an appeal to the 
Council level because the ALJ or attorney adjudicator has not completed 
his or her action on the request for hearing within an applicable 
adjudication period under Sec.  405.1016, the request for escalation 
must be filed with OMHA and the appellant must also send a copy of the 
request for escalation to the other parties who were sent a copy of the 
QIC reconsideration. Failure to copy the other parties tolls the 
Council's adjudication deadline set forth in Sec.  405.1100 until all 
parties who were sent a copy of the QIC reconsideration receive notice 
of the request for escalation. In a case that has been escalated from 
OMHA, the Council's 180 calendar day period to issue a final decision, 
dismissal order, or remand order begins on the date the request for 
escalation is received by the Council.


Sec.  405.1108  [Amended]

0
60. Section 405.1108 is amended by--
0
a. Amending the section heading and paragraphs (a), (b), (c), (d) 
introductory text, (d)(2), and (4) by removing the term ``MAC'' each 
time it appears and adding ``Council'' in its place.
0
b. Amending paragraphs (a), (b), (c), (d)(1), and (5) by removing the 
term ``ALJ'' each time it appears and adding ``ALJ or attorney 
adjudicator'' in its place.
0
c. Amending paragraphs (a) and (b) by removing the term ``ALJ's'' each 
time it appears and adding ``ALJ's or attorney adjudicator's'' in its 
place.
0
d. Amending paragraph (b) by removing the first use of ``dismissal'' in 
the paragraph and adding ``dismissal of a request for a hearing'' in 
its place.
0
e. Amending paragraph (d) introductory text by removing the term ``ALJ 
level'' and adding ``OMHA level'' in its place.
0
f. Amending paragraph (d)(3) by removing the phrase ``to an ALJ'' and 
adding ``to OMHA'' in its place.
0
61. Section 405.1110 is revised to read as follows:


Sec.  405.1110  Council reviews on its own motion.

    (a) General rule. The Council may decide on its own motion to 
review a decision or dismissal issued by an ALJ or attorney 
adjudicator. CMS or any of its contractors may refer a case to the 
Council for it to consider reviewing under this authority anytime 
within 60 calendar days after the date of an ALJ's or attorney 
adjudicator's decision or dismissal.
    (b) Referral of cases. (1) CMS or any of its contractors may refer 
a case to the Council if, in their view, the decision or dismissal 
contains an error of law material to the outcome of the claim or 
presents a broad policy or procedural issue that may affect the public 
interest. CMS may also request that the Council take own motion review 
of a case if--
    (i) CMS or its contractor participated in the appeal at the OMHA 
level; and
    (ii) In CMS' view, the ALJ's or attorney adjudicator's decision or 
dismissal is not supported by the preponderance of evidence in the 
record or the ALJ or attorney adjudicator abused his or her discretion.
    (2) CMS' referral to the Council is made in writing and must be 
filed with the Council no later than 60 calendar days after the ALJ's 
or attorney adjudicator's decision or dismissal is issued. The written 
referral will state the reasons why CMS believes the Council must 
review the case on its own motion. CMS will send a copy of its referral 
to all parties to the ALJ's or attorney adjudicator's action who 
received a copy of the hearing decision under Sec.  405.1046(a) or the 
notice of dismissal under Sec.  405.1052(d), and to the OMHA Chief ALJ. 
Parties to the ALJ's or attorney adjudicator's action may file 
exceptions to the referral by submitting written comments to the 
Council within 20 calendar days of the referral notice. A party 
submitting comments to the Council must send such comments to CMS and 
all other parties to the ALJ's or attorney adjudicator's action who 
received a copy of the hearing decision under Sec.  405.1046(a) or the 
notice of dismissal under Sec.  405.1052(d).
    (c) Standard of review--(1) Referral by CMS after participation at 
the OMHA level. If CMS or its contractor participated in an appeal at 
the OMHA level, the Council exercises its own motion authority if there 
is an error of law material to the outcome of the case, an abuse of 
discretion by the ALJ or attorney adjudicator, the decision is not 
consistent with the preponderance of the evidence of record, or there 
is a broad policy or procedural issue that may affect the general 
public interest. In deciding whether to accept review under this 
standard, the Council will limit its consideration of the ALJ's or 
attorney adjudicator's action to those exceptions raised by CMS.
    (2) Referral by CMS when CMS did not participate in the OMHA 
proceedings or appear as a party. The Council will accept review if the 
decision or dismissal contains an error of law material to the outcome 
of the case or presents a broad policy or procedural issue that may 
affect the general public interest. In deciding whether to accept 
review, the Council will limit its consideration of the ALJ's or 
attorney adjudicator's action to those exceptions raised by CMS.
    (d) Council's action. If the Council decides to review a decision 
or dismissal on its own motion, it will mail the results of its action 
to all the parties to the hearing and to CMS if it is not already a 
party to the hearing. The Council may adopt, modify, or reverse the 
decision or dismissal, may remand the case to an ALJ or attorney 
adjudicator for further proceedings or may dismiss a hearing request. 
The Council must issue its action no later than 90 calendar days after 
receipt of the CMS referral, unless the 90 calendar day period has been 
extended as provided in this subpart. The Council may not, however, 
issue its action before the 20 calendar day comment period has expired, 
unless it determines that the agency's referral does not provide a 
basis for reviewing the case. If the Council does not act within the 
applicable adjudication deadline, the ALJ's or attorney adjudicator's 
decision or dismissal is binding on the parties to the ALJ's or 
attorney adjudicator's action.
0
62. Section 405.1112 is revised to read as follows:


Sec.  405.1112  Content of request for review.

    (a) The request for Council review must be filed with the entity 
specified in the notice of the ALJ's or attorney adjudicator's action. 
The request for

[[Page 43875]]

review must be in writing and may be made on a standard form. A written 
request that is not made on a standard form is accepted if it contains 
the beneficiary's name; Medicare health insurance claim number; the 
specific service(s) or item(s) for which the review is requested; the 
specific date(s) of service; the date of the ALJ's or attorney 
adjudicator's decision or dismissal order, if any; and the name and 
signature of the party or the representative of the party; and any 
other information CMS may decide.
    (b) The request for review must identify the parts of the ALJ's or 
attorney adjudicator's action with which the party requesting review 
disagrees and explain why he or she disagrees with the ALJ's or 
attorney adjudicator's decision, dismissal, or other determination 
being appealed. For example, if the party requesting review believes 
that the ALJ's or attorney adjudicator's action is inconsistent with a 
statute, regulation, CMS Ruling, or other authority, the request for 
review should explain why the appellant believes the action is 
inconsistent with that authority.
    (c) The Council will limit its review of an ALJ's or attorney 
adjudicator's actions to those exceptions raised by the party in the 
request for review, unless the appellant is an unrepresented 
beneficiary. For purposes of this section only, we define a 
representative as anyone who has accepted an appointment as the 
beneficiary's representative, except a member of the beneficiary's 
family, a legal guardian, or an individual who routinely acts on behalf 
of the beneficiary, such as a family member or friend who has a power 
of attorney.


Sec.  405.1114  [Amended]

0
63. Section 405.1114 is amended by--
0
a. Amending the introductory text and paragraphs (b) and (c)(1) by 
removing the term ``MAC'' each time it appears and adding ``Council'' 
in its place.
0
b. Amending paragraph (c)(3) by removing the phrase ``ALJ hearing'' and 
adding ``ALJ's or attorney adjudicator's action'' in its place.


Sec.  405.1116  [Amended]

0
64. Section 405.1116 is amended by--
0
a. Removing the term ``MAC'' each time it appears in the heading and 
text and adding ``Council'' in its place.
0
b. Removing the term ``MAC's'' and adding ``Council's'' in its place.
0
c. Removing the term ``ALJ'' and adding ``ALJ or attorney adjudicator'' 
in its place.


Sec.  405.1118  [Amended]

0
65. Section 405.1118 is amended by--
0
a. Removing the term ``MAC'' each time it appears in the heading and 
text and adding ``Council'' in its place.
0
b. Removing the phrase ``ALJ hearing'' and adding ``ALJ's or attorney 
adjudicator's action'' in its place.
0
c. Removing the phrase ``the exhibits list'' and adding ``any index of 
the administrative record'' in its place.
0
d. Removing the term ``tape'' and adding ``audio recording'' in its 
place.
0
e. Removing the term ``MAC's'' and adding ``Council's'' in its place.


Sec.  405.1120  [Amended]

0
66. Section 405.1120 is amended in the heading and text by removing the 
term ``MAC'' each time it appears and adding ``Council'' in its place.


Sec.  405.1122  [Amended]

0
67. Section 405.1122 is amended by--
0
a. Amending the section heading and paragraphs (a) paragraph heading, 
(a)(1) and (2), (b) paragraph heading, (b)(1) and (2), (c)(1), (2), and 
(3) introductory text, (c)(3)(ii), (d)(1) and (3), (e)(1), (2), (3), 
and (4), and (f)(1), (2), and (3) by removing the term ``MAC'' each 
time it appears and adding ``Council'' in its place.
0
b. Amending paragraphs (e)(5) and (6), and (f)(2) by removing the term 
``MAC's'' and adding ``Council's'' in its place.
0
c. Amending paragraph (a)(1) by removing the term ``hearing decision'' 
and adding ``ALJ's or attorney adjudicator's decision'' in its place.
0
d. Amending paragraphs (a)(1) and (b)(1) by removing the term ``ALJ 
level'' and adding ``OMHA level'' in its place.
0
e. Amending paragraphs (a)(1) and (2), (b)(1) and (2), (c)(2), (c)(3) 
introductory text, and (c)(3)(i) and (ii) by removing the term ``ALJ'' 
each time it appears and adding ``ALJ or attorney adjudicator'' in its 
place.
0
f. Amending paragraphs (a) paragraph heading and (a)(1) by removing the 
term ``ALJ's'' and adding ``ALJ's or attorney adjudicator's'' in its 
place.
0
g. Amending paragraph (a)(2) by removing the term ``hearing record'' 
and adding ``administrative record'' in its place.


Sec.  405.1124  [Amended]

0
68. Section 405.1124 is amended by removing the term ``MAC'' each time 
it appears and adding ``Council'' in its place.


Sec.  405.1126  [Amended]

0
69. Section 405.1126 is amended by--
0
a. Amending the section heading and paragraphs (a), (b), (c), (d) 
paragraph heading, (d)(1) and (2), (e) paragraph heading, and (e)(1) 
and (2) by removing the term ``MAC'' each time it appears and adding 
``Council'' in its place.
0
b. Amending paragraph (b) by removing the term ``MAC's'' and adding 
``Council's'' in its place.
0
c. Amending paragraphs (a), (b), (c), (d) paragraph heading, and (e)(2) 
by removing the term ``ALJ'' each time it appears and adding ``ALJ or 
attorney adjudicator'' in its place.
0
d. Amending paragraph (e)(2) by adding ``if applicable'' after the word 
``rehearing''.


Sec.  405.1128  [Amended]

0
70. Section 405.1128 is amended by--
0
a. Amending the section heading and paragraphs (a), (b), and (c) by 
removing the term ``MAC'' each time it appears and adding ``Council'' 
in its place.
0
b. Amending paragraph (a) by removing the term ``ALJ'' and adding ``ALJ 
or attorney adjudicator'' in its place.
0
c. Amending paragraph (b) by removing the term ``ALJ hearing decision'' 
and adding ``ALJ's or attorney adjudicator's decision'' in its place.


Sec.  405.1130  [Amended]

0
71. Section 405.1130 is amended in the section heading and text by 
removing the term ``MAC's'' each time it appears and adding 
``Council's'' in its place.


Sec.  405.1132  [Amended]

0
72. Section 405.1132 is amended by--
0
a. Amending paragraphs (a) introductory text, (a)(2), and (b) by 
removing the term ``MAC'' each time it appears and adding ``Council'' 
in its place.
0
b. Amending paragraph (b) by removing the term ``MAC's'' and adding 
``Council's'' in its place.
0
c. Amending paragraphs (a) introductory text, (a)(1), and (b) by 
removing the term ``ALJ'' each time it appears and adding ``ALJ or 
attorney adjudicator'' in its place.


Sec.  405.1134  [Amended]

0
73. Section 405.1134 is amended by--
0
a. Amending paragraph (a) by removing the term ``MAC's'' and adding 
``Council's'' in its place.
0
b. Amending paragraphs (b)(3) and (c) by removing the term ``MAC'' and 
adding ``Council'' in its place.


Sec.  405.1136  [Amended]

0
74. Section 405.1136 is amended by--
0
a. Amending paragraphs (a)(1) and (2), and (c)(3) by removing the term 
``MAC'' each time it appears and adding ``Council'' in its place.
0
b. Amending paragraph (a)(1) by removing the term ``ALJ's'' and adding

[[Page 43876]]

``ALJ's or attorney adjudicator's'' in its place.
0
c. Amending paragraphs (a)(2) and (c)(2) by removing the term ``MAC's'' 
each time it appears and adding ``Council's'' in its place.
0
d. Amending paragraph (c)(3) by removing the term ``ALJ'' and adding 
``ALJ or attorney adjudicator'' in its place.


Sec.  405.1138  [Amended]

0
75. Section 405.1138 is amended by--
0
a. Removing the term ``MAC'' each time it appears and adding 
``Council'' in its place.
0
b. Removing the term ``ALJ'' and adding ``ALJ or attorney adjudicator'' 
in its place.


Sec.  405.1140  [Amended]

0
76. Section 405.1140 is amended by--
0
a. Amending the section heading and paragraphs (a)(1), (2), and (3), 
(b)(1), (2), and (3), (c) paragraph heading, (c)(1), (3), and (4), and 
(d) by removing the term ``MAC'' each time it appears and adding 
``Council'' in its place.
0
b. Amending the section heading and paragraphs (a)(1), (2), and (3), 
(b) paragraph heading, (b)(1), (2), and (3), (c)(1) and (4), and (d) by 
removing the term ``ALJ'' each time it appears and adding ``ALJ or 
attorney adjudicator'' in its place.
0
c. Amending paragraph (d) by removing the term ``ALJ's'' and adding 
``ALJ's or attorney adjudicator's'' in its place.
0
77. Section 405.1204 is amended by revising paragraphs (c)(4)(iii) and 
(c)(5) to read as follows:


Sec.  405.1204  Expedited reconsiderations.

* * * * *
    (c) * * *
    (4) * * *
    (iii) Information about the beneficiary's right to appeal the QIC's 
reconsideration decision to OMHA for an ALJ hearing in accordance with 
subpart I of this part, including how to request an appeal and the time 
period for doing so.
    (5) Unless the beneficiary requests an extension in accordance with 
paragraph (c)(6) of this section, if the QIC does not issue a decision 
within 72 hours of receipt of the request, the QIC must notify the 
beneficiary of his or her right to have the case escalated to OMHA for 
an ALJ hearing in accordance with subpart I of this part, if the amount 
remaining in controversy after the QIO determination meets the 
requirements for an ALJ hearing under Sec.  405.1006.
* * * * *

PART 422--MEDICARE ADVANTAGE PROGRAM

0
78. The authority citation for part 422 continues to read as follows:

    Authority: Secs. 1102 and 1871 of the Social Security Act (42 
U.S.C. 1302 and 1395hh).


Sec.  422.561  [Amended]

0
79. Section 422.561 is amended, in the definition of ``Appeal,'' by 
removing the phrase ``Medicare Appeals Council (MAC)'' and adding 
``Medicare Appeals Council (Council)'' in its place.
0
80. Section 422.562 is amended by--
0
a. Amending paragraph (b)(4)(v) by removing the term ``MAC'' and adding 
``Council'' in its place.
0
b. Revising paragraphs (c)(1) and (d) to read as follows:


Sec.  422.562  General provisions.

* * * * *
    (c) * * *
    (1) If an enrollee receives immediate QIO review (as provided in 
Sec.  422.622) of a determination of noncoverage of inpatient hospital 
care the enrollee is not entitled to review of that issue by the MA 
organization.
* * * * *
    (d) When other regulations apply. Unless this subpart provides 
otherwise, the regulations in part 405 of this chapter (concerning the 
administrative review and hearing processes and representation of 
parties under titles II and XVIII of the Act) apply under this subpart 
to the extent they are appropriate, unless the part 405 regulation 
implements a provision of section 1869 of the Act that is not also in 
section 1852(g)(5) of the Act.
0
81. Section 422.594 is amended by revising paragraph (b)(2) to read as 
follows:


Sec.  422.594  Notice of reconsidered determination by the independent 
entity.

* * * * *
    (b) * * *
    (2) If the reconsidered determination is adverse (that is, does not 
completely reverse the MA organization's adverse organization 
determination), inform the parties of their right to an ALJ hearing if 
the amount in controversy meets the requirements of Sec.  422.600;
* * * * *
0
82. Section 422.602 is amended by revising paragraph (b) to read as 
follows:


Sec.  422.602  Request for an ALJ hearing.

* * * * *
    (b) When to file a request. (1) Except when an ALJ or attorney 
adjudicator extends the time frame as provided in part 405 of this 
chapter, a party must file a request for a hearing within 60 calendar 
days of receipt of the notice of a reconsidered determination. The time 
and place for a hearing before an ALJ will be set in accordance with 
Sec.  405.1020.
    (2) For purposes of this section, the date of receipt of the 
reconsideration is presumed to be 5 calendar days after the date of the 
notice of the reconsidered determination, unless there is evidence to 
the contrary.
* * * * *
0
83. Section 422.608 is revised to read as follows:


Sec.  422.608  Medicare Appeals Council (Council) review.

    Any party to the ALJ's or attorney adjudicator's decision or 
dismissal, including the MA organization, who is dissatisfied with the 
decision or dismissal, may request that the Council review the decision 
or dismissal. The regulations under part 405 of this chapter regarding 
Council review apply to matters addressed by this subpart to the extent 
that they are appropriate, unless the part 405 regulation implements a 
provision of section 1869 of the Act that is not also in section 
1852(g)(5) of the Act.


Sec.  422.612  [Amended]

0
84. Section 422.612 is amended by--
0
a. Amending paragraph (a) paragraph heading and introductory text by 
removing the term ``ALJ's'' and adding ``ALJ's or attorney 
adjudicator's'' in its place.
0
b. Amending paragraph (a)(1) by removing the term ``Board'' and adding 
``Council'' in its place.
0
c. Amending paragraph (b) by removing the term ``MAC'' each time it 
appears and adding ``Council'' in its place.


Sec.  422.616  [Amended]

0
85. Section 422.616 is amended in paragraph (a) by removing the terms 
``ALJ'' and ``MAC'' and adding in their place ``ALJ or attorney 
adjudicator'' and ``Council'' respectively.


Sec.  422.618  [Amended]

0
86. Section 422.618 is amended by--
0
a. Amending paragraph (c)(1) by removing the term ``ALJ'' and adding 
``ALJ or attorney adjudicator'' in its place.
0
b. Amending paragraph (c)(2) by removing the terms ``Medicare Appeals 
Council'', ``Medicare Appeals Council (the Board)'', and ``Board'' and 
adding ``Council'' in their place.


Sec.  422.619  [Amended]

0
87. Section 422.619 is amended by--

[[Page 43877]]

0
a. Amending paragraph (c)(1) by removing the term ``ALJ'' and adding 
``ALJ or attorney adjudicator'' in its place.
0
b. Amending paragraph (c)(2) by removing the terms ``Medicare Appeals 
Council'', ``Medicare Appeals Council (the Board)'', and ``Board'' and 
adding ``Council'' in their place.


Sec.  422.622  [Amended]

0
88. Section 422.622 (g)(2) is amended by removing the phrase ``may 
appeal to an ALJ, the MAC, or a federal court'' and adding ``may appeal 
to OMHA for an ALJ hearing, the Council, or a federal court'' in its 
place.


Sec.  422.626  [Amended]

0
89. Section 422.626(g)(3) is amended by removing the phrase ``to an 
ALJ, the MAC, or a Federal court'' and adding ``to OMHA for an ALJ 
hearing, the Council, or a Federal court'' in its place.

PART 423--VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT

0
90. The authority citation for part 423 continues to read as follows:

    Authority: Sections 1102, 1106, 1860D-1 through 1860D-42, and 
1871 of the Social Security Act (42 U.S.C. 1302, 1306, 1395w-101 
through 1395w-152, and 1395hh).


Sec.  423.560  [Amended]

0
91. Section 423.560 is amended by amending the definition of ``Appeal'' 
by removing the term ``Medicare Appeals Council (MAC)'' and adding 
``Medicare Appeals Council (Council) in its place.
0
92. Section 423.562 is amended by revising paragraphs (b)(4)(v) and 
(vi) to read as follows:


Sec.  423.562  General provisions.

* * * * *
    (b) * * *
    (4) * * *
    (v) If the ALJ or attorney adjudicator affirms the IRE's adverse 
coverage determination, in whole or in part, the right to request 
Council review of the ALJ's or attorney adjudicator's decision, as 
specified in Sec.  423.1974.
    (vi) If the Council affirms the ALJ's or attorney adjudicator's 
adverse coverage determination, in whole or in part, the right to 
judicial review of the decision if the amount in controversy meets the 
requirements in Sec.  423.1976.
* * * * *

Subpart U--Reopening, ALJ Hearings and ALJ and Attorney Adjudicator 
Decisions, MAC Review, and Judicial Review

0
93. The heading of subpart U is revised to read as set forth above.
0
94. Section 423.1968 is revised to read as follows:


Sec.  423.1968  Scope.

    This subpart sets forth the requirements relating to the following:
    (a) Part D sponsors, the Part D IRE, ALJs and attorney 
adjudicators, and the Council with respect to reopenings.
    (b) ALJs with respect to hearings and decisions or decisions of 
attorney adjudicators if no hearing is conducted.
    (c) The Council with respect to review of Part D appeals.
    (d) Part D enrollees' rights with respect to reopenings, ALJ 
hearings and ALJ or attorney adjudicator reviews, Council reviews, and 
judicial review by a Federal District Court.
0
95. Section 423.1970 is amended by revising paragraphs (c)(1)(ii) and 
(iii), and (c)(2)(ii) and (iii) to read as follows:


Sec.  423.1970  Right to an ALJ hearing.

* * * * *
    (c) * * *
    (1) * * *
    (ii) The enrollee requests aggregation at the same time the 
requests for hearing are filed, and the request for aggregation and 
requests for hearing are filed within 60 calendar days after receipt of 
the notice of reconsideration for each of the reconsiderations being 
appealed, unless the deadline to file one or more of the requests for 
hearing has been extended in accordance with Sec.  423.2014(d); and
    (iii) The appeals the enrollee seeks to aggregate involve the 
delivery of prescription drugs to a single enrollee, as determined by 
an ALJ or attorney adjudicator. Only an ALJ may determine the appeals 
the enrollee seeks to aggregate do not involve the delivery of 
prescription drugs to a single enrollee.
    (2) * * *
    (ii) The enrollees request aggregation at the same time the 
requests for hearing are filed, and the request for aggregation and 
requests for hearing are filed within 60 calendar days after receipt of 
the notice of reconsideration for each of the reconsiderations being 
appealed, unless the deadline to file one or more of the requests for 
hearing has been extended in accordance with Sec.  423.2014(d); and
    (iii) The appeals the enrollees seek to aggregate involve the same 
prescription drugs, as determined by an ALJ or attorney adjudicator. 
Only an ALJ may determine the appeals the enrollees seek to aggregate 
do not involve the same prescription drugs.
0
96. Section 423.1972 is amended by revising paragraphs (a), (b), and 
(c)(1) to read as follows:


Sec.  423.1972  Request for an ALJ hearing.

    (a) How and where to file a request. The enrollee must file a 
written request for a hearing with the OMHA office specified in the 
IRE's reconsideration notice.
    (b) When to file a request. (1) Except when an ALJ or attorney 
adjudicator extends the timeframe as provided in Sec.  423.2014(d), the 
enrollee must file a request for a hearing within 60 calendar days of 
receipt of the notice of an IRE reconsideration determination. The time 
and place for a hearing before an ALJ will be set in accordance with 
Sec.  423.2020
    (2) For purposes of this section, the date of receipt of the 
reconsideration determination is presumed to be 5 calendar days after 
the date of the written reconsideration determination, unless there is 
evidence to the contrary.
    (c) * * *
    (1) If a request for a hearing clearly shows that the amount in 
controversy is less than that required under Sec.  423.1970, the ALJ or 
attorney adjudicator dismisses the request.
* * * * *
0
97. Section 423.1974 is revised to read as follows:


Sec.  423.1974  Council review.

    An enrollee who is dissatisfied with an ALJ's or attorney 
adjudicator's decision or dismissal may request that the Council review 
the ALJ's or attorney adjudicator's decision or dismissal as provided 
in Sec.  423.2102.


Sec.  423.1976  [Amended]

0
98. Section 423.1976 is amended by--
0
a. Amending paragraph (a) paragraph heading and introductory text by 
removing the term ``ALJ's'' and adding ``ALJ's or attorney 
adjudicator's'' in its place.
0
b. Amending paragraphs (a)(1) and (b) by removing the term ``MAC'' each 
time it appears and adding ``Council'' in its place.


Sec.  423.1978  [Amended]

0
99. Section 423.1978(a) is amended by removing the phrase ``ALJ or the 
MAC'' and adding ``ALJ or attorney adjudicator or the Council'' in its 
place.
0
100. Section 423.1980 is amended by revising the section heading and 
paragraphs (a)(1)(iii) and (iv), (a)(2) and (4), (d) paragraph heading, 
(d)(2) and (3), (e) paragraph heading, and (e)(2) and (3) to read as 
follows:


Sec.  423.1980  Reopening of coverage determinations, redeterminations, 
reconsiderations, decisions, and reviews.

    (a) * * *
    (1) * * *
    (iii) An ALJ or attorney adjudicator to revise his or her decision; 
or

[[Page 43878]]

    (iv) The Council to revise the ALJ or attorney adjudicator 
decision, or its review decision.
    (2) When an enrollee has filed a valid request for an appeal of a 
coverage determination, redetermination, reconsideration, ALJ or 
attorney adjudicator decision, or Council review, no adjudicator has 
jurisdiction to reopen an issue that is under appeal until all appeal 
rights for that issue are exhausted. Once the appeal rights for the 
issue have been exhausted, the Part D plan sponsor, IRE, ALJ or 
attorney adjudicator, or Council may reopen as set forth in this 
section.
* * * * *
    (4) Consistent with Sec.  423.1978(d), the Part D plan sponsor's, 
IRE's, ALJ's or attorney adjudicator's, or Council's decision on 
whether to reopen is binding and not subject to appeal.
* * * * *
    (d) Time frame and requirements for reopening reconsiderations, 
decisions and reviews initiated by an IRE, ALJ or attorney adjudicator, 
or the Council.
* * * * *
    (2) An ALJ or attorney adjudicator may reopen his or her decision, 
or the Council may reopen an ALJ or attorney adjudicator decision on 
its own motion within 180 calendar days from the date of the decision 
for good cause in accordance with Sec.  423.1986. If the decision was 
procured by fraud or similar fault, then the ALJ or attorney 
adjudicator may reopen his or her decision, or the Council may reopen 
an ALJ or attorney adjudicator decision at any time.
    (3) The Council may reopen its review decision on its own motion 
within 180 calendar days from the date of the review decision for good 
cause in accordance with Sec.  423.1986. If the Council's decision was 
procured by fraud or similar fault, then the Council may reopen at any 
time.
    (e) Time frames and requirements for reopening reconsiderations, 
decisions, and reviews requested by an enrollee or a Part D plan 
sponsor.
* * * * *
    (2) An enrollee who received an ALJ's or attorney adjudicator's 
decision or a Part D plan sponsor may request that an ALJ or attorney 
adjudicator reopen his or her decision, or the Council reopen an ALJ or 
attorney adjudicator decision, within 180 calendar days from the date 
of the decision for good cause in accordance with Sec.  423.1986.
    (3) An enrollee who received a Council decision or a Part D plan 
sponsor may request that the Council reopen its decision within 180 
calendar days from the date of the review decision for good cause in 
accordance with Sec.  423.1986.


Sec.  423.1982  [Amended]

0
101. Section 423.1982 is amended by--
0
a. Amending paragraphs (a)(1) and (2), and (b)(1) and (2) by removing 
the term ``ALJ'' and adding ``ALJ or attorney adjudicator'' in its 
place.
0
b. Amending paragraphs (a)(1) and (2) and (b)(1) and (2) by removing 
the term ``MAC'' and adding ``Council'' in its place.
0
102. Section 423.1984 is amended by revising paragraphs (d) and (e) to 
read as follows:


Sec.  423.1984  Effect of a revised determination or decision.

* * * * *
    (d) ALJ or attorney adjudicator decisions. The revision of an ALJ 
or attorney adjudicator decision is binding unless an enrollee submits 
a request for a Council review that is accepted and processed as 
specified in Sec.  423.1974 and Sec.  423.2100 through Sec.  423.2130.
    (e) Council review. The revision of a Council determination or 
decision is binding unless an enrollee files a civil action in which a 
Federal District Court accepts jurisdiction and issues a decision.
* * * * *
0
103. Section 423.1990 is amended by--
0
a. Amending paragraphs (a)(2), (b)(1) introductory text, (b)(1)(ii), 
and (b)(4) by removing the term ``MAC'' each time it appears and adding 
``Council'' in its place
0
b. Amending paragraph (d)(2)(ii) by removing the term ``MAC's'' and 
adding ``Council's'' in its place.
0
c. Amending paragraph (b)(1)(i) by removing the phrase ``final 
decision'' and adding ``decision'' in its place and by removing the 
phrase ``order of the ALJ'' and adding ``order of the ALJ or an 
attorney adjudicator'' in its place.
0
d. Amending paragraph (b)(1)(ii) by removing the term ``ALJ'' and 
adding ``ALJ or attorney adjudicator'' in its place.
0
e. Amending paragraphs (c)(3), (4), and (5) by removing the term ``ALJ 
hearing decision'' and adding ``ALJ or attorney adjudicator decision'' 
in its place.
0
f. Revising paragraph (d)(1).
0
g. Amending paragraph (d)(2)(i) by removing the term ``ALJ's'' and 
adding ``ALJ's or attorney adjudicator's'' in its place.
0
h. Revising paragraph (h).
    The revisions read as follows:


Sec.  423.1990  Expedited access to judicial review.

* * * * *
    (d) * * *
    (1) Method and place for filing request. The enrollee may--
    (i) If a request for ALJ hearing or Council review is not pending, 
file a written EAJR request with the HHS Departmental Appeals Board, 
with his or her request for an ALJ hearing or Council review; or
    (ii) If an appeal is already pending for an ALJ hearing or 
otherwise before OMHA or the Council, file a written EAJR request with 
the HHS Departmental Appeals Board.
* * * * *
    (h) Rejection of EAJR. (1) If a request for EAJR does not meet all 
the conditions set out in paragraphs (b), (c) and (d) of this section, 
or if the review entity does not certify a request for EAJR, the review 
entity advises the enrollee in writing that the request has been 
denied, and forwards the request to OMHA or the Council, which will 
treat it as a request for hearing or for Council review, as 
appropriate.
    (2) Whenever a review entity forwards a rejected EAJR request to 
OMHA or the Council, the appeal is considered timely filed and, if an 
adjudication time frame applies to the appeal, the adjudication time 
frame begins on the day the request is received by OMHA or the Council 
from the review entity.
0
104. Section 423.2000 is amended by revising the section heading and 
paragraphs (a), (b), (c), (d), (e), and (g) to read as follows:


Sec.  423.2000  Hearing before an ALJ and decision by an ALJ or 
attorney adjudicator: General rule.

    (a) If an enrollee is dissatisfied with an IRE's reconsideration, 
the enrollee may request a hearing before an ALJ.
    (b) A hearing before an ALJ may be conducted in-person, by video-
teleconference, or by telephone. At the hearing, the enrollee may 
submit evidence subject to the restrictions in Sec.  423.2018, examine 
the evidence used in making the determination under review, and present 
and/or question witnesses.
    (c) In some circumstances, the Part D plan sponsor, CMS, or the IRE 
may participate in the proceedings on a request for an ALJ hearing as 
specified in Sec.  423.2010.
    (d) The ALJ or attorney adjudicator conducts a de novo review and 
issues a decision based on the administrative record, including, for an 
ALJ, any hearing record.
    (e) If an enrollee waives his or her right to appear at the hearing 
in person

[[Page 43879]]

or by telephone or video-teleconference, the ALJ or an attorney 
adjudicator may make a decision based on the evidence that is in the 
file and any new evidence that is submitted for consideration.
* * * * *
    (g) An ALJ or attorney adjudicator may also issue a decision on the 
record on his or her own initiative if the evidence in the 
administrative record supports a fully favorable finding.


Sec.  423.2002  [Amended]

0
105. Section 423.2002 is amended by--
0
a. Amending paragraph (a) introductory text by removing the phrase 
``may request'' and adding ``has a right to'' in its place.
0
b. Amending paragraph (c) by removing the phrase ``The ALJ'' and adding 
``OMHA'' in its place.
0
c. Amending paragraph (e) by removing the word ``entity'' and adding 
``office'' in its place.
0
106. Section 423.2004 is amended by revising the section heading and 
paragraphs (a) introductory text, (a)(1) and (4), (b), and (c) and 
adding paragraph (d) to read as follows:


Sec.  423.2004  Right to a review of IRE notice of dismissal.

    (a) An enrollee has a right to have an IRE's dismissal of a request 
for reconsideration reviewed by an ALJ or attorney adjudicator if--
    (1) The enrollee files a written request for review within 60 
calendar days after receipt of the notice of the IRE's dismissal.
* * * * *
    (4) For purposes of meeting the 60 calendar day filing deadline, 
the request is considered as filed on the date it is received by the 
office specified in the IRE's dismissal.
    (b) If the ALJ or attorney adjudicator determines that the IRE's 
dismissal was in error, he or she vacates the dismissal and remands the 
case to the IRE for a reconsideration in accordance with Sec.  
423.2056.
    (c) If the ALJ or attorney adjudicator affirms the IRE's dismissal 
of a reconsideration request, he or she issues a notice of decision 
affirming the IRE's dismissal in accordance with Sec.  423.2046(b).
    (d) The ALJ or attorney adjudicator may dismiss the request for 
review of an IRE's dismissal in accordance with Sec.  423.2052(b).
0
107. Section 423.2008 is revised to read as follows:


Sec.  423.2008  Parties to the proceedings on a request for an ALJ 
hearing.

    The enrollee (or the enrollee's representative) who filed the 
request for hearing is the only party to the proceedings on a request 
for an ALJ hearing.
0
108. Section 423.2010 is revised to read as follows:


Sec.  423.2010  When CMS, the IRE, or Part D plan sponsors may 
participate in the proceedings on a request for an ALJ hearing.

    (a) When CMS, the IRE, or the Part D plan sponsor may participate. 
(1) CMS, the IRE, and/or the Part D plan sponsor may request to 
participate in the proceedings on a request for an ALJ hearing upon 
filing a request to participate in accordance with paragraph (b) of 
this section.
    (2) An ALJ may request, but may not require, CMS, the IRE, and/or 
the Part D plan sponsor to participate in any proceedings before the 
ALJ, including the oral hearing, if any. The ALJ cannot draw any 
adverse inferences if CMS, the IRE, and/or the Part D plan sponsor 
decide not to participate in any proceedings before an ALJ, including 
the hearing.
    (b) How a request to participate is made--(1) No notice of hearing. 
If CMS, the IRE, and/or the Part D plan sponsor requests participation 
before it receives a notice of hearing, or when no notice is required, 
it must send written notice of its request to participate to the 
assigned ALJ or attorney adjudicator, or a designee of the Chief ALJ if 
the request is not yet assigned to an ALJ or attorney adjudicator, and 
the enrollee, except that the request may be made orally if a request 
for an expedited hearing was filed and OMHA will notify the enrollee of 
the request to participate.
    (2) Notice of hearing. If CMS, the IRE, and/or the Part D plan 
sponsor requests participation after the IRE and Part D plan sponsor 
receive a notice of hearing, it must send written notice of its request 
to participate to the ALJ and the enrollee, except that the request to 
participate may be made orally for an expedited hearing and OMHA will 
notify the enrollee of the request to participate.
    (3) Timing of request. CMS, the IRE, and/or the Part D plan sponsor 
must send its request to participate--
    (i) If a standard request for hearing was filed, if no hearing is 
scheduled, within 30 calendar days after notification that a standard 
request for hearing was filed;
    (ii) If an expedited hearing is requested, but no hearing has been 
scheduled, within 2 calendar days after notification that a request for 
an expedited hearing was filed.
    (iii) If a non-expedited hearing is scheduled, within 5 calendar 
days after receiving the notice of hearing; or
    (iv) If an expedited hearing is scheduled, within 1 calendar day 
after receiving the notice of hearing. Requests may be made orally or 
submitted by facsimile to the hearing office.
    (c) The ALJ's or attorney adjudicator's decision on a request to 
participate. The assigned ALJ or attorney adjudicator has discretion 
not to allow CMS, the IRE, and/or the Part D plan sponsor to 
participate. The ALJ or attorney adjudicator must notify the entity 
requesting participation, the Part D plan sponsor, if applicable, and 
the enrollee of his or her decision on the request to participate 
within the following time frames--
    (1) If no hearing is scheduled, at least 20 calendar days before 
the ALJ or attorney adjudicator issues a decision, dismissal, or 
remand;
    (2) If a non-expedited hearing is scheduled, within 5 calendar days 
of receipt of a request to participate; or
    (3) If an expedited hearing is scheduled, within 1 calendar of 
receipt of a request to participate.
    (d) Roles and responsibilities of CMS, the IRE, and/or the Part D 
plan sponsor as a participant. (1) Participation may include filing 
position papers and/or providing testimony to clarify factual or policy 
issues in a case, but it does not include calling witnesses or cross-
examining the witnesses of an enrollee to the hearing.
    (2) When CMS, the IRE, and/or the Part D plan sponsor participates 
in an ALJ hearing, CMS, the IRE, and/or the Part D plan sponsor may not 
be called as a witness during the hearing and is not subject to 
examination or cross-examination by the enrollee, but the enrollee may 
provide testimony to rebut factual or policy statements made by a 
participant and the ALJ may question the participant about its 
testimony.
    (3) CMS, IRE, and/or Part D plan sponsor positon papers and written 
testimony are subject to the following:
    (i) Unless the ALJ or attorney adjudicator grants additional time 
to submit a position paper or written testimony, a position paper and 
written testimony must be submitted--
    (A) Within 14 calendar days for a standard appeal, or 1 calendar 
day for an expedited appeal, after receipt of the ALJ's or attorney 
adjudicator's decision on a request to participate if no hearing has 
been scheduled; or
    (B) No later than 5 calendar days prior to the hearing if a non-
expedited hearing is scheduled, or 1 calendar day prior to the hearing 
if an expedited hearing is scheduled.
    (ii) A copy of any position paper and written testimony that CMS, 
the IRE, or

[[Page 43880]]

the Part D plan sponsor submits to OMHA must be sent to the enrollee.
    (iii) If CMS, the IRE, and/or the Part D plan sponsor fails to send 
a copy of its position paper or written testimony to the enrollee or 
fails to submit its position paper or written testimony within the time 
frames described in this section, the position paper or written 
testimony will not be considered in deciding the appeal.
    (e) Invalid requests to participate. (1) An ALJ or attorney 
adjudicator may determine that a CMS, IRE, and/or Part D plan sponsor 
request to participate is invalid under this section if the request to 
participate was not timely filed or the request to participate was not 
sent to the enrollee.
    (2) If the request to participate is determined to be invalid, the 
written notice of an invalid request to participate must be sent to the 
entity that made the request to participate and the enrollee.
    (i) If no hearing is scheduled or the request to participate was 
made after the hearing occurred, the written notice of an invalid 
request to participate must be sent no later than the date the notice 
of decision, dismissal, or remand is mailed.
    (ii) If a non-expedited hearing is scheduled, the written notice of 
an invalid request to participate must be sent prior to the hearing. If 
the notice would be sent fewer than 5 calendar days before the hearing 
is scheduled to occur, oral notice must be provided to the entity that 
submitted the request, and the written notice must be sent as soon as 
possible after the oral notice is provided.
    (iii) If an expedited hearing is scheduled, oral notice of an 
invalid request to participate must be provided to the entity that 
submitted the request, and the written notice must be sent as soon as 
possible after the oral notice is provided.
0
109. Section 423.2014 is revised to read as follows:


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

    (a) Content of the request. (1) The request for an ALJ hearing or a 
review of an IRE dismissal must be made in writing, except as set forth 
in paragraph (b) of this section. The request, including any oral 
request, must include all of the following--
    (i) The name, address, telephone number, and Medicare health 
insurance claim number of the enrollee.
    (ii) The name, address, and telephone number of the appointed 
representative, as defined at Sec.  423.560, if any.
    (iii) The Medicare appeal number, if any, assigned to the IRE 
reconsideration or dismissal being appealed.
    (iv) The prescription drug in dispute.
    (v) The plan name.
    (vi) The reasons the enrollee disagrees with the IRE's 
reconsideration or dismissal being appealed.
    (vii) A statement of whether the enrollee is aware that he or she, 
or the prescription for the drug being appealed, is the subject of an 
investigation or proceeding by the HHS Office of Inspector General or 
other law enforcement agencies.
    (2) The enrollee must submit a statement of any additional evidence 
to be submitted and the date it will be submitted.
    (3) The enrollee must submit a statement that the enrollee is 
requesting an expedited hearing, if applicable.
    (b) Request for expedited hearing. If an enrollee is requesting 
that the hearing be expedited, the enrollee may make the request for an 
ALJ hearing orally, but only after receipt of the written IRE 
reconsideration notice. OMHA must document all oral requests in writing 
and maintain the documentation in the case files. A prescribing 
physician or other prescriber may provide oral or written support for 
an enrollee's request for expedited review.
    (c) Complete request required. (1) A request must contain the 
information in paragraph (a)(1) of this section to the extent the 
information is applicable, to be considered complete. If a request is 
not complete, the enrollee will be provided with an opportunity to 
complete the request, and if an adjudication time frame applies it does 
not begin until the request is complete. If the enrollee fails to 
provide the information necessary to complete the request within the 
time frame provided, the enrollee's request for hearing or review will 
be dismissed.
    (2) If supporting materials submitted with a request clearly 
provide information required for a complete request, the materials will 
be considered in determining whether the request is complete.
    (d) When and where to file. Consistent with Sec. Sec.  423.1972(a) 
and (b), the request for an ALJ hearing after an IRE reconsideration or 
request for review of an IRE dismissal must be filed:
    (1) Within 60 calendar days from the date the enrollee receives 
written notice of the IRE's reconsideration or dismissal being 
appealed.
    (2) With the office specified in the IRE's reconsideration or 
dismissal.
    (i) If the request for hearing is timely filed with an office other 
than the office specified in the IRE's reconsideration, any applicable 
time frame specified in Sec.  423.2016 for deciding the appeal begins 
on the date the office specified in the IRE's reconsideration or 
dismissal receives the request for hearing.
    (ii) If the request for hearing is filed with an office, other than 
the office specified in the IRE's reconsideration or dismissal, OMHA 
must notify the enrollee of the date the request was received in the 
correct office and the commencement of any applicable adjudication 
timeframe.
    (e) Extension of time to request a hearing or review. (1) 
Consistent with Sec.  423.1972(b), if the request for hearing or review 
is not filed within 60 calendar days of receipt of the written IRE's 
reconsideration or dismissal, an enrollee may request an extension for 
good cause.
    (2) Any request for an extension of time must be in writing or, for 
expedited reviews, in writing or oral. OMHA must document all oral 
requests in writing and maintain the documentation in the case file.
    (3) The request must give the reasons why the request for a hearing 
or review was not filed within the stated time period, and must be 
filed with the request for hearing or review of an IRE dismissal with 
the office specified in the notice of reconsideration or dismissal.
    (4) An ALJ or attorney adjudicator may find there is good cause for 
missing the deadline to file a request for an ALJ hearing or request 
for review of an IRE dismissal, or there is no good cause for missing 
the deadline to file a request for a review of an IRE dismissal, but 
only an ALJ may find there is no good cause for missing the deadline to 
file a request for an ALJ hearing. If good cause is found for missing 
the deadline, the time period for filing the request for hearing or 
request for review of an IRE dismissal will be extended. To determine 
whether good cause for late filing exists, the ALJ or attorney 
adjudicator uses the standards set forth in Sec.  405.942(b)(2) and (3) 
of this chapter.
    (5) If a request for hearing is not timely filed, any applicable 
adjudication period in Sec.  423.2016 begins the date the ALJ or 
attorney adjudicator grants the request to extend the filing deadline.
    (6) A determination granting a request to extend the filing 
deadline is not subject to further review.
0
110. Section 423.2016 is revised to read as follows:


Sec.  423.2016  Timeframes for deciding an appeal of an IRE 
reconsideration.

    (a) Standard appeals. (1) When a request for an ALJ hearing is 
filed after an IRE has issued a written

[[Page 43881]]

reconsideration, an ALJ or attorney adjudicator issues a decision, 
dismissal order, or remand, as appropriate, no later than the end of 
the 90 calendar day period beginning on the date the request for 
hearing is received by the office specified in the IRE's notice of 
reconsideration, unless the 90 calendar day period has been extended as 
provided in this subpart.
    (2) The adjudication period specified in paragraph (a)(1) of this 
section begins on the date that a timely filed request for hearing is 
received by the office specified in the IRE's reconsideration, or, if 
it is not timely filed, the date that the ALJ or attorney adjudicator 
grants any extension to the filing deadline.
    (3) If the Council remands a case and the case was subject to an 
adjudication time frame under paragraph (a)(1) of this section, the 
remanded appeal will be subject to the same adjudication time frame 
beginning on the date that OMHA receives the Council remand.
    (b) Expedited appeals--(1) Standard for expedited appeal. An ALJ or 
attorney adjudicator issues an expedited decision if the appeal 
involves an issue specified in Sec.  423.566(b), but is not solely a 
request for payment of Part D drugs already furnished, and the 
enrollee's prescribing physician or other prescriber indicates, or an 
ALJ or attorney adjudicator determines that applying the standard 
timeframe for making a decision may seriously jeopardize the enrollee's 
life, health or ability to regain maximum function. An ALJ or attorney 
adjudicator may consider this standard as met if a lower level 
adjudicator has granted a request for an expedited hearing.
    (2) Grant of a request. If an ALJ or attorney adjudicator grants a 
request for expedited hearing, an ALJ or attorney adjudicator must--
    (i) Make the decision to grant an expedited appeal within 5 
calendar days of receipt of the request for an expedited hearing;
    (ii) Give the enrollee prompt oral notice of this decision; and
    (iii) Subsequently send to the enrollee at his or her last known 
address and to the Part D plan sponsor written notice of the decision. 
This notice may be provided within the written notice of hearing.
    (3) Denial of a request. If an ALJ or attorney adjudicator denies a 
request for expedited hearing, an ALJ or attorney adjudicator must--
    (i) Make this decision within 5 calendar days of receipt of the 
request for expedited hearing;
    (ii) Give the enrollee prompt oral notice of the denial that 
informs the enrollee of the denial and explains that an ALJ or attorney 
adjudicator will process the enrollee's request using the 90 calendar 
day timeframe for non-expedited appeals; and
    (iii) Subsequently send to the enrollee at his or her last known 
address and to the Part D plan sponsor an equivalent written notice of 
the decision within 3 calendar days after the oral notice.
    (4) Decision not appealable. A decision on a request for expedited 
hearing may not be appealed.
    (5) Time frame for adjudication. (i) If an ALJ or attorney 
adjudicator accepts a request for expedited hearing, an ALJ or attorney 
adjudicator issues a written decision, dismissal order, or remand as 
expeditiously as the enrollee's health condition requires, but no later 
than the end of the 10 calendar day period beginning on the date the 
request for hearing is received by the office specified in the IRE's 
written notice of reconsideration, unless the 10 calendar day period 
has been extended as provided in this subpart.
    (ii) The adjudication period specified in paragraph (b)(5)(i) of 
this section begins on the date that a timely provided request for 
hearing is received by the office specified in the IRE's 
reconsideration, or, if it is not timely provided, the date that an ALJ 
or attorney adjudicator grants any extension to the filing deadline.
    (6) Time frame for Council remands. If the Council remands a case 
and the case was subject to an adjudication time frame under paragraph 
(b)(5) of this section, the remanded appeal will be subject to the same 
adjudication timeframe beginning on the date that OMHA receives the 
Council remand, if the standards for an expedited appeal continue to be 
met. If the standards for an expedited appeal are no longer met, the 
appeal will be subject to the adjudication time frame for a standard 
appeal.
    (c) Waivers and extensions of adjudication period. (1) At any time 
during the adjudication process, the enrollee may waive the 
adjudication period specified in paragraphs (a)(1) and (b)(5) of this 
section. The waiver may be for a specific period of time agreed upon by 
the ALJ or attorney adjudicator and the enrollee.
    (2) The adjudication periods specified in paragraphs (a)(1) and 
(b)(5) of this section are extended as otherwise specified in this 
subpart, and for the following events--
    (i) The duration of a stay of action on adjudicating the matters at 
issue ordered by a court or tribunal of competent jurisdiction;
    (ii) The duration of a stay of proceedings granted by an ALJ or 
attorney adjudicator on a motion by an enrollee.
0
111. Section 423.2018 is revised to read as follows:


Sec.  423.2018  Submitting evidence.

    (a) All appeals. An enrollee must submit any written or other 
evidence that he or she wishes to have considered.
    (1) An ALJ or attorney adjudicator will not consider any evidence 
submitted regarding a change in condition of an enrollee after the 
appealed coverage determination was made.
    (2) An ALJ or attorney adjudicator will remand a case to the Part D 
IRE where an enrollee wishes evidence on his or her change in condition 
after the coverage determination to be considered.
    (b) Non-expedited appeals. (1) Except as provided in this 
paragraph, a represented enrollee must submit all written or other 
evidence he or she wishes to have considered with the request for 
hearing by the date specified in the request for hearing in accordance 
with Sec.  423.2014(a)(2), or, if a hearing is scheduled, within 10 
calendar days of receiving the notice of hearing.
    (2) If a represented enrollee submits written or other evidence 
later than 10 calendar days after receiving the notice of hearing, any 
applicable adjudication period specified in Sec.  423.2016 is extended 
by the number of calendar days in the period between 10 calendar days 
after receipt of the notice of hearing and the day the evidence is 
received.
    (3) The requirements of paragraph (b) of this section do not apply 
to unrepresented enrollees.
    (c) Expedited appeals. (1) Except as provided in this section, an 
enrollee must submit all written or other evidence he or she wishes to 
have considered with the request for hearing by the date specified in 
the request for hearing pursuant to Sec.  423.2014(a)(2), or, if an 
expedited hearing is scheduled, within 2 calendar days of receiving the 
notice of the expedited hearing.
    (2) If an enrollee submits written or other evidence later than 2 
calendar days after receiving the notice of expedited hearing, any 
applicable adjudication period specified in Sec.  423.2016 is extended 
by the number of calendar days in the period between 2 calendar days 
after receipt of the notice of expedited hearing and the day the 
evidence is received.
    (d) When this section does not apply. The requirements of 
paragraphs (b) and (c) of this section do not apply to oral testimony 
given at a hearing.

[[Page 43882]]

0
112. Section 423.2020 is amended by
0
a. Revising paragraphs (b), (c), (d), and (e)(3) and (4).
0
b. Adding paragraphs (g)(3)(vii) and (viii).
0
c. Revising paragraphs (h), (i) paragraph heading, and (i)(1), (2), 
(4), and (5).
0
d. Adding paragraph (j).
    The revisions and additions read as follows:


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

* * * * *
    (b) Determining how appearances are made. (1) Appearances by 
unrepresented enrollees. The ALJ will direct that the appearance of an 
unrepresented enrollee who filed a request for hearing be conducted by 
video-teleconferencing if the ALJ finds that video-teleconferencing 
technology is available to conduct the appearance, unless the ALJ finds 
good cause for an in-person appearance.
    (i) The ALJ may also offer to conduct a hearing by telephone if the 
request for hearing or administrative record suggests that a telephone 
hearing may be more convenient for the unrepresented enrollee.
    (ii) The ALJ, with the concurrence of the Chief ALJ or designee, 
may find good cause that an in-person hearing should be conducted if--
    (A) The video-teleconferencing or telephone technology is not 
available; or
    (B) Special or extraordinary circumstances exist.
    (2) Appearances by represented enrollees. The ALJ will direct that 
the appearance of an individual, other than an unrepresented enrollee 
who filed a request for hearing, be conducted by telephone, unless the 
ALJ finds good cause for an appearance by other means.
    (i) The ALJ may find good cause for an appearance by video-
teleconferencing if he or she determines that video-teleconferencing is 
necessary to examine the facts or issues involved in the appeal.
    (ii) The ALJ, with the concurrence of the Chief ALJ or designee, 
may find good cause that an in-person hearing should be conducted if--
    (A) The video-teleconferencing or telephone technology is not 
available; or
    (B) Special or extraordinary circumstances exist.
    (c) Notice of hearing. (1) A notice of hearing is sent to the 
enrollee, the Part D plan sponsor that issued the coverage 
determination, and the IRE that issued the reconsideration, advising 
them of the proposed time and place of the hearing.
    (2) The notice of hearing will require the enrollee to reply to the 
notice by:
    (i) Acknowledging whether they plan to attend the hearing at the 
time and place proposed in the notice of hearing, or whether they 
object to the proposed time and/or place of the hearing;
    (ii) If the representative is an entity or organization, specifying 
who from the entity or organization plans to attend the hearing, if 
anyone, and in what capacity, in addition to the individual who filed 
the request for hearing; and
    (iii) Listing the witnesses who will be providing testimony at the 
hearing.
    (3) The notice of hearing will require CMS, the IRE, or the Part D 
plan sponsor that requests to attend the hearing as a participant to 
reply to the notice by:
    (i) Acknowledging whether it plans to attend the hearing at the 
time and place proposed in the notice of hearing; and
    (ii) Specifying who from the entity plans to attend the hearing,
    (d) An enrollee's right to waive a hearing. An enrollee may also 
waive the right to a hearing and request a decision based on the 
written evidence in the record in accordance with Sec.  423.2038(b).
    (1) As specified in Sec.  423.2000, an ALJ may require the enrollee 
to attend a hearing if it is necessary to decide the case.
    (2) If an ALJ determines that it is necessary to obtain testimony 
from a person other than the enrollee, he or she may still hold a 
hearing to obtain that testimony, even if the enrollee has waived the 
right to appear. In those cases, the ALJ would give the enrollee the 
opportunity to appear when the testimony is given but may hold the 
hearing even if the enrollee decides not to appear.
* * * * *
    (e) * * *
    (3) The objection must be in writing except for an expedited 
hearing when the objection may be provided orally, and except that the 
enrollee may orally request that a non-expedited hearing be rescheduled 
in an emergency circumstance the day prior to or day of the hearing. 
The ALJ must document all oral objections to the time and place of a 
hearing in writing and maintain the documentation in the case files.
    (4) The ALJ may change the time or place of the hearing if the 
enrollee has good cause.
* * * * *
    (g) * * *
    (3) * * *
    (vii) The enrollee or enrollee's representative has a prior 
commitment that cannot be changed without significant expense.
    (viii) The enrollee or enrollee's representative asserts he or she 
did not receive the notice of hearing and is unable to appear at the 
scheduled time and place.
    (h) Effect of rescheduling hearing. If a hearing is postponed at 
the request of the enrollee for any of the above reasons, the time 
between the originally scheduled hearing date and the new hearing date 
is not counted toward the adjudication period specified in Sec.  
423.2016.
    (i) An enrollee's request for an in-person or video-
teleconferencing hearing. (1) If an unrepresented enrollee objects to a 
video-teleconferencing hearing or to the ALJ's offer to conduct a 
hearing by telephone, or a represented enrollee who filed the request 
for hearing objects to a telephone or video-teleconferencing hearing, 
the enrollee or the enrollee's representative must notify the ALJ at 
the earliest possible opportunity before the time set for the hearing 
and request a video-teleconferencing or an in-person hearing.
    (2) The enrollee must state the reason for the objection and state 
the time and/or place he or she wants an in-person or video-
teleconferencing hearing to be held.
* * * * *
    (4) When an enrollee's request for an in-person or video-
teleconferencing hearing is granted and an adjudication time frame 
applies in accordance with Sec.  423.2016, the ALJ issues a decision, 
dismissal, or remand to the IRE within the adjudication time frame 
specified in Sec.  423.2016 (including any applicable extensions 
provided in this subpart), unless the enrollee requesting the hearing 
agrees to waive such adjudication timeframe in writing.
    (5) The ALJ may grant the request, with the concurrence of the 
Chief ALJ or designee, upon a finding of good cause and will reschedule 
the hearing for a time and place when the enrollee may appear in person 
or by video-teleconference before the ALJ.
    (j) Amended notice of hearing. If the ALJ changes or will change 
the time and/or place of the hearing, an amended notice of hearing must 
be sent to the enrollee and CMS, the IRE, and/or the Part D plan 
sponsor in accordance with Sec.  423.2022(a)(2).
0
113. Section 423.2022 is revised to read as follows:


Sec.  423.2022  Notice of a hearing before an ALJ.

    (a) Issuing the notice. (1) After the ALJ sets the time and place 
of the hearing, the notice of the hearing will be mailed or otherwise 
transmitted in accordance with OMHA procedures to the enrollee and 
other potential participants, as provided in Sec.  423.2020(c) at their 
last

[[Page 43883]]

known addresses, or given by personal service, except to an enrollee or 
other potential participant who indicates in writing that he or she 
does not wish to receive this notice.
    (2) The notice is mailed, transmitted, or served at least 20 
calendar days before the hearing, except for expedited hearings where 
written notice is mailed, transmitted, or served at least 3 calendar 
days before the hearing, unless the enrollee or other potential 
participant agrees in writing to the notice being mailed, transmitted, 
or served fewer than 20 calendar days before the non-expedited hearing 
or 3 calendar days before the expedited hearing. For expedited 
hearings, the ALJ may orally provide notice of the hearing to the 
enrollee and other potential participants but oral notice must be 
followed by an equivalent written notice within 1 calendar day of the 
oral notice.
    (b) Notice information. (1) The notice of hearing contains--
    (i) A statement that the issues before the ALJ include all of the 
issues brought out in the coverage determination, redetermination, or 
reconsideration that were not decided entirely in the enrollee's favor 
and that were specified in the request for hearing; and
    (ii) A statement of any specific new issues the ALJ will consider 
in accordance with Sec.  423.2032.
    (2) The notice will inform the enrollee that he or she may 
designate a person to represent him or her during the proceedings.
    (3) The notice must include an explanation of the procedures for 
requesting a change in the time or place of the hearing, a reminder 
that the ALJ may dismiss the hearing request if the enrollee fails to 
appear at the scheduled hearing without good cause, and other 
information about the scheduling and conduct of the hearing.
    (4) The enrollee will also be told if his or her appearance or that 
of any other witness is scheduled by video-teleconferencing, telephone, 
or in person. If the ALJ has scheduled the enrollee to appear at the 
hearing by video-teleconferencing, the notice of hearing will advise 
that the scheduled place for the hearing is a video-teleconferencing 
site and explain what it means to appear at the hearing by video-
teleconferencing.
    (5) The notice advises the enrollee that if he or she objects to 
appearing by video-teleconferencing or telephone, and wishes instead to 
have his or her hearing at a time and place where he or she may appear 
in person before the ALJ, he or she must follow the procedures set 
forth at Sec.  423.2020(i) for notifying the ALJ of his or her 
objections and for requesting an in-person hearing.
    (c) Acknowledging the notice of hearing. (1) If the enrollee or his 
or her representative does not acknowledge receipt of the notice of 
hearing, OMHA attempts to contact the enrollee for an explanation.
    (2) If the enrollee states that he or she did not receive the 
notice of hearing, a copy of the notice is sent to him or her by 
certified mail or other means requested by the enrollee and in 
accordance with OMHA procedures.
    (3) The enrollee may request that the ALJ reschedule the hearing in 
accordance with Sec.  423.2020(e).
0
114. Section 423.2024 is amended by--
0
a. Amending paragraph (a) by removing the phrase ``The ALJ hearing 
office'' and adding ``OMHA'' in its place.
0
b. Revising paragraph (c) to read as follows:


Sec.  423.2024  Objections to the issues.

* * * * *
    (c) The ALJ makes a decision on the objections either in writing, 
at a prehearing conference, or at the hearing.
0
115. Section 423.2026 is revised to read as follows:


Sec.  423.2026  Disqualification of the ALJ or attorney adjudicator.

    (a) An ALJ or attorney adjudicator may not adjudicate an appeal if 
he or she is prejudiced or partial to the enrollee or has any interest 
in the matter pending for decision.
    (b) If an enrollee objects to the ALJ or attorney adjudicator 
assigned to adjudicate the appeal, the enrollee must notify the ALJ 
within 10 calendar days of the date of the notice of hearing if a non-
expedited hearing is scheduled, except for expedited hearings in which 
the enrollee must submit written or oral notice no later than 2 
calendar days after the date of the notice of hearing, or the ALJ or 
attorney adjudicator at any time before a decision, dismissal order, or 
remand order is issued if no hearing is scheduled. The ALJ or attorney 
adjudicator must document all oral objections in writing and maintain 
the documentation in the case files. The ALJ or attorney adjudicator 
considers the enrollee's objections and decides whether to proceed with 
the appeal or withdraw.
    (c) If the ALJ or attorney adjudicator withdraws, another ALJ or 
attorney adjudicator will be assigned to adjudicate the appeal. If the 
ALJ or attorney adjudicator does not withdraw, the enrollee may, after 
the ALJ or attorney adjudicator has issued an action in the case, 
present his or her objections to the Council in accordance with Sec.  
423.2100 through Sec.  423.2130. The Council will then consider whether 
the decision or dismissal should be revised or, if applicable, a new 
hearing held before another ALJ.
    (d) If the enrollee objects to the ALJ or attorney adjudicator and 
the ALJ or attorney adjudicator subsequently withdraws from the appeal, 
any adjudication period that applies to the appeal in accordance with 
Sec.  423.2016 is extended by 14 calendar days for a standard appeal, 
or 2 calendar days for an expedited appeal.
0
116. Section 423.2030 is revised to read as follows:


Sec.  423.2030  ALJ hearing procedures.

    (a) General rule. A hearing is open to the enrollee and to other 
persons the ALJ considers necessary and proper.
    (b) At the hearing. (1) The ALJ fully examines the issues, 
questions the enrollee and other witnesses, and may accept evidence 
that is material to the issues consistent with Sec.  423.2018.
    (2) The ALJ may limit testimony and argument at the hearing that 
are not relevant to an issue before the ALJ, or that address an issue 
before the ALJ for which the ALJ determines he or she has sufficient 
information or on which the ALJ has already ruled. The ALJ may, but is 
not required to, provide the enrollee or representative with an 
opportunity to submit additional written statements and affidavits on 
the matter in lieu of testimony and/or argument at the hearing. The 
written statements and affidavits must be submitted within the time 
frame designated by the ALJ.
    (3) If the ALJ determines that the enrollee or enrollee's 
representative is uncooperative, disruptive to the hearing, or abusive 
during the course of the hearing, the ALJ may excuse the enrollee or 
representative from the hearing and continue with the hearing to 
provide the participants with an opportunity to offer testimony and/or 
argument. If an enrollee or representative was excused from the 
hearing, the ALJ will provide the enrollee or representative with an 
opportunity to submit written statements and affidavits in lieu of 
testimony and/or argument at the hearing, and the enrollee or 
representative may request a recording of the hearing in accordance 
with Sec.  423.2042 and respond in writing to any statements made by 
participants and/or testimony of the witnesses at the hearing. The 
written statements and affidavits must be submitted within the time 
frame designated by the ALJ.

[[Page 43884]]

    (c) Missing evidence. The ALJ may also stop the hearing temporarily 
and continue it at a later date if he or she believes that there is 
material evidence missing at the hearing.
    (d) Effect of new evidence on adjudication period. If an enrollee, 
other than an unrepresented enrollee in a standard appeal, submits 
evidence pursuant to paragraph (b) or (c), and an adjudication period 
applies to the appeal, the adjudication period specified in Sec.  
423.2016 is extended in accordance with Sec.  423.2018(b) or (c), as 
applicable.
    (e) Continued hearing. (1) A hearing may be continued to a later 
date. Notice of the continued hearing must be sent in accordance with 
Sec.  423.2022, except that a waiver of notice of the hearing may be 
made in writing or on the record, and the notice is sent to the 
enrollee and participants who attended the hearing, and any additional 
potential participants the ALJ determines are appropriate.
    (2) If the enrollee requests the continuance and an adjudication 
time frame applies to the appeal in accordance with Sec.  423.2016, the 
adjudication period is extended by the period between the initial 
hearing date and the continued hearing date.
    (f) Supplemental hearing. (1) The ALJ may conduct a supplemental 
hearing at any time before he or she mails a notice of the decision in 
order to receive new and material evidence, obtain additional 
testimony, or address a procedural matter. The ALJ determines whether a 
supplemental hearing is necessary and if one is held, the scope of the 
hearing, including when evidence is presented and what issues are 
discussed. Notice of the supplemental hearing must be sent in 
accordance with Sec.  423.2022, except that the notice is sent to the 
enrollee and participants who attended the hearing, and any additional 
potential participants the ALJ determines are appropriate.
    (2) If the enrollee requests the supplemental hearing and an 
adjudication period applies to the appeal in accordance with Sec.  
423.2016, the adjudication period is extended by the period between the 
initial hearing date and the supplemental hearing date.
0
117. Section 423.2032 is revised to read as follows:


Sec.  423.2032  Issues before an ALJ or attorney adjudicator.

    (a) General rule. The issues before the ALJ or attorney adjudicator 
include all the issues for the appealed matter specified in the request 
for hearing that were brought out in the coverage determination, 
redetermination, or reconsideration that were not decided entirely in 
an enrollee's favor.
    (b) New issues--(1) When a new issue may be considered. A new issue 
may include issues resulting from the participation of CMS, the IRE, or 
the Part D plan sponsor at the OMHA level of adjudication and from any 
evidence and position papers submitted by CMS, the IRE, or the Part D 
plan sponsor for the first time to the ALJ. The ALJ or the enrollee may 
raise a new issue; however, the ALJ may only consider a new issue 
relating to a determination or appealed matter specified in the request 
for hearing, including a favorable portion of a determination or 
appealed matter specified in the request for hearing, if its resolution 
could have a material impact on the appealed matter and--
    (i) There is new and material evidence that was not available or 
known at the time of the determination and that may result in a 
different conclusion; or
    (ii) The evidence that was considered in making the determination 
clearly shows on its face that an obvious error was made at the time of 
the determination.
    (2) Notice of the new issue. The ALJ may consider a new issue at 
the hearing if he or she notifies the enrollee about the new issue 
before the start of the hearing.
    (3) Opportunity to submit evidence. If notice of the new issue is 
sent after the notice of hearing, the enrollee will have at least 10 
calendar days in standard appeals or 2 calendar days in expedited 
appeals after receiving notice of the new issue to submit evidence 
regarding the issue, and without affecting any applicable adjudication 
period. If a hearing is conducted before the time to submit evidence 
regarding the issue expires, the record will remain open until the 
opportunity to submit evidence expires.
    (c) Adding coverage determinations to a pending appeal. A coverage 
determination on a drug that was not specified in a request for hearing 
may only be added to pending appeal if the coverage determination was 
adjudicated in the same reconsideration that is appealed, and the 
period to request an ALJ hearing for that reconsideration has not 
expired, or an ALJ or attorney adjudicator extends the time to request 
an ALJ hearing on the reconsideration in accordance with Sec.  
423.2014(e).
0
118. Section 423.2034 is revised to read as follows:


Sec.  423.2034  Requesting information from the IRE.

    (a) If an ALJ or attorney adjudicator believes that the written 
record is missing information that is essential to resolving the issues 
on appeal and that information can be provided only by CMS, the IRE, 
and/or the Part D plan sponsor, the information may be requested from 
the IRE that conducted the reconsideration or its successor.
    (1) Official copies of redeterminations and reconsiderations that 
were conducted on the appealed issues can only be provided by CMS, the 
IRE, and/or the Part D plan sponsor.
    (2) ``Can be provided only by CMS, the IRE, and/or the Part D plan 
sponsor'' means the information is not publicly available, is not in 
the possession of the enrollee, and cannot be requested and obtained by 
the enrollee. Information that is publicly available is information 
that is available to the general public via the Internet or in a 
printed publication. Information that is publicly available includes, 
but is not limited to, information available on a CMS, IRE or Part D 
Plan sponsor Web site or information in an official CMS or HHS 
publication.
    (b) The ALJ or attorney adjudicator retains jurisdiction of the 
case, and the case remains pending at OMHA.
    (c) The IRE has 15 calendar days for standard appeals, or 2 
calendar days for expedited appeals, after receiving the request for 
information to furnish the information or otherwise respond to the 
information request directly or through CMS or the Part D plan sponsor.
    (d) If an adjudication period applies to the appeal in accordance 
with Sec.  423.2016, the adjudication period is extended by the period 
between the date of the request for information and the date the IRE 
responds to the request or 20 calendar days after the date of the 
request for standard appeals, or 3 calendar days after the date of the 
request for expedited appeals, whichever occurs first.


Sec.  423.2036  [Amended]

0
119. Section 423.2036 is amended by--
0
a. Amending paragraph (b)(1) introductory text by removing the phrase 
``send the ALJ'' and adding ``submit to OMHA'' in its place.
0
b. Amending paragraph (b)(1)(ii) by removing the phrase ``The ALJ 
hearing office'' and adding ``OMHA'' in its place.
0
c. Removing paragraph (d).
0
d. Redesignating paragraph (g) as new paragraph (d).
0
e. Amending paragraphs (f)(2), (f)(3) introductory text, and (f)(3) 
(i), (ii), and (iii) by removing the term ``MAC'' and adding 
``Council'' in its place.

[[Page 43885]]

0
f. Amending paragraph (f)(2) by removing the term ``MAC's'' and adding 
``Council's'' in its place.
0
120. Section 423.2038 is revised to read as follows:


Sec.  423.2038  Deciding a case without a hearing before an ALJ.

    (a) Decision fully favorable. If the evidence in the administrative 
record supports a finding fully in favor of the enrollee(s) on every 
issue, the ALJ or attorney adjudicator may issue a decision without 
giving the enrollee(s) prior notice and without an ALJ conducting a 
hearing. The notice of the decision informs the enrollee(s) that he or 
she has the right to a hearing and a right to examine the evidence on 
which the decision is based.
    (b) Enrollee does not wish to appear. (1) The ALJ or attorney 
adjudicator may decide a case on the record and without an ALJ 
conducting a hearing if--
    (i) The enrollee indicates in writing or, for expedited hearings 
orally or in writing, that he or she does not wish to appear before an 
ALJ at a hearing, including a hearing conducted by telephone or video-
teleconferencing, if available. OMHA must document all oral requests 
not to appear at a hearing in writing and maintain the documentation in 
the case files; or
    (ii) The enrollee lives outside the United States and does not 
inform OMHA that he or she wants to appear at a hearing before an ALJ.
    (2) When a hearing is not held, the decision of the ALJ or attorney 
adjudicator must refer to the evidence in the record on which the 
decision was based.
    (c) Stipulated decision. If CMS, the IRE, and/or the Part D plan 
sponsor submits a written statement or makes an oral statement at a 
hearing indicating the drug should be covered or payment may be made, 
an ALJ or attorney adjudicator may issue a stipulated decision finding 
in favor of the enrollee on the basis of the statement, and without 
making findings of fact, conclusions of law, or further explaining the 
reasons for the decision.
0
121. Section 423.2040 is revised to read as follows:


Sec.  423.2040  Prehearing and posthearing conferences.

    (a) The ALJ may decide on his or her own, or at the request of the 
enrollee to the hearing, to hold a prehearing or posthearing conference 
to facilitate the hearing or the hearing decision.
    (b) For non-expedited hearings, the ALJ informs the enrollee, and 
CMS, the IRE, and/or the Part D plan sponsor if the ALJ has granted 
their request(s) to be a participant to the hearing at the time the 
notice of conference is sent, of the time, place, and purpose of the 
conference at least 7 calendar days before the conference date, unless 
the enrollee indicates in writing that he or she does not wish to 
receive a written notice of the conference.
    (c) For expedited hearings, the ALJ informs the enrollee, and CMS, 
the IRE, and/or the Part D plan sponsor if the ALJ has granted their 
request(s) to be a participant to the hearing, of the time, place, and 
purpose of the conference at least 2 calendar days before the 
conference date, unless the enrollee indicates orally or in writing 
that he or she does not wish to receive a written notice of the 
conference.
    (d) All oral requests not to receive written notice of the 
conference must be documented in writing and the documentation must be 
made part of the administrative record.
    (e) At the conference--
    (1) The ALJ or an OMHA attorney designated by the ALJ conducts the 
conference, but only the ALJ conducting a conference may consider 
matters in addition to those stated in the conference notice, if the 
enrollee consents to consideration of the additional matters in 
writing.
    (2) An audio recording of the conference is made.
    (f) The ALJ issues an order to the enrollee and all participants 
who attended the conference stating all agreements and actions 
resulting from the conference. If the enrollee does not object within 
10 calendar days of receiving the order for non-expedited hearings or 1 
calendar day for expedited hearings, or any additional time granted by 
the ALJ, the agreements and actions become part of the administrative 
record and are binding on the enrollee.
0
122. Section 423.2042 is revised to read as follows:


Sec.  423.2042  The administrative record.

    (a) Creating the record. (1) OMHA makes a complete record of the 
evidence and administrative proceedings on the appealed matter, 
including any prehearing and posthearing conference and hearing 
proceedings that were conducted.
    (2) The record will include marked as exhibits, the appealed 
determinations and documents and other evidence used in making the 
appealed determinations and the ALJ's or attorney adjudicator's 
decision, including, but not limited to, medical records, written 
statements, certificates, reports, affidavits, and any other evidence 
the ALJ or attorney adjudicator admits. The record will also include 
any evidence excluded or not considered by the ALJ or attorney 
adjudicator, including but not limited to duplicative evidence 
submitted by the enrollee.
    (3) An enrollee may request and receive a copy of the record prior 
to or at the hearing, or, if a hearing is not held, at any time before 
the notice of decision is issued.
    (4) If a request for review is filed, the complete record, 
including any prehearing and posthearing conference and hearing 
recordings, is forwarded to the Council.
    (5) A typed transcription of the hearing is prepared if an enrollee 
seeks judicial review of the case in a Federal district court within 
the stated time period and all other jurisdictional criteria are met, 
unless, upon the Secretary's motion prior to the filing of an answer, 
the court remands the case.
    (b) Requesting and receiving copies of the record. (1) While an 
appeal is pending at OMHA, an enrollee may request and receive a copy 
of all or part of the record from OMHA, including any index of the 
administrative record, documentary evidence, and a copy of the audio 
recording of the oral proceedings. The enrollee may be asked to pay the 
costs of providing these items.
    (2) If an enrollee requests a copy of all or part of the record 
from OMHA or the ALJ or attorney adjudicator and an opportunity to 
comment on the record, any adjudication period that applies in 
accordance with Sec.  423.2016 is extended by the time beginning with 
the receipt of the request through the expiration of the time granted 
for the enrollee's response.
    (3) If the enrollee requests a copy of all or part of the record 
and the record, including any audio recordings, contains information 
pertaining to an individual that the enrollee is not entitled to 
receive, such as personally identifiable information or protected 
health information, such portions of the record will not be furnished 
unless the enrollee obtains consent from the individual.
0
123. Section 423.2044 is revised to read as follows:


Sec.  423.2044  Consolidated proceedings.

    (a) Consolidated hearing. (1) A consolidated hearing may be held if 
one or more of the issues to be considered at the hearing are the same 
issues that are involved in one or more other appeals pending before 
the same ALJ.
    (2) It is within the discretion of the ALJ to grant or deny an 
enrollee's request for consolidation. In considering an enrollee's 
request, the ALJ may consider factors such as whether the

[[Page 43886]]

issue(s) may be more efficiently decided if the appeals are 
consolidated for hearing. In considering the enrollee's request for 
consolidation, the ALJ must take into account any adjudication 
deadlines for each appeal and may require an enrollee to waive the 
adjudication deadline associated with one or more appeals if 
consolidation otherwise prevents the ALJ from deciding all of the 
appeals at issue within their respective deadlines.
    (3) The ALJ may also propose on his or her own motion to 
consolidate two or more appeals in one hearing for administrative 
efficiency, but may not require an enrollee to waive the adjudication 
deadline for any of the consolidated cases.
    (4) Notice of a consolidated hearing must be included in the notice 
of hearing issued in accordance with Sec. Sec.  423.2020 and 423.2022.
    (b) Consolidated decision and record. (1) If the ALJ decides to 
hold a consolidated hearing, he or she may make either--
    (i) A consolidated decision and record; or
    (ii) A separate decision and record on each appeal.
    (2) If a separate decision and record on each appeal is made, the 
ALJ is responsible for making sure that any evidence that is common to 
all appeals and material to the common issue to be decided, and audio 
recordings of any conferences that were conducted and the consolidated 
hearing are included in each individual administrative record, as 
applicable.
    (3) If a hearing will not be conducted for multiple appeals that 
are before the same ALJ or attorney adjudicator, and the appeals 
involve one or more of the same issues, the ALJ or attorney adjudicator 
may make a consolidated decision and record at the request of the 
enrollee or on the ALJ's or attorney adjudicator's own motion.
    (c) Limitation on consolidated proceedings. Consolidated 
proceedings may only be conducted for appeals filed by the same 
enrollee, unless multiple enrollees aggregated appeals to meet the 
amount in controversy requirement in accordance with Sec.  423.1970 and 
the enrollees have all authorized disclosure of information to the 
other enrollees.
0
124. Section 423.2046 is revised to read as follows:


Sec.  423.2046  Notice of an ALJ or attorney adjudicator decision.

    (a) Decisions on requests for hearing--(1) General rule. Unless the 
ALJ or attorney adjudicator dismisses or remands the request for 
hearing, the ALJ or attorney adjudicator will issue a written decision 
that gives the findings of fact, conclusions of law, and the reasons 
for the decision.
    (i) The decision must be based on evidence offered at the hearing 
or otherwise admitted into the record, and shall include independent 
findings and conclusions.
    (ii) A copy of the decision should be mailed or otherwise 
transmitted to the enrollee at his or her last known address.
    (iii) A copy of the written decision should also be provided to the 
IRE that issued the reconsideration determination, and to the Part D 
plan sponsor that issued the coverage determination.
    (2) Content of the notice. The decision must be provided in a 
manner calculated to be understood by an enrollee and must include--
    (i) The specific reasons for the determination, including, to the 
extent appropriate, a summary of any clinical or scientific evidence 
used in making the determination;
    (ii) The procedures for obtaining additional information concerning 
the decision; and
    (iii) Notification of the right to appeal the decision to the 
Council, including instructions on how to initiate an appeal under this 
section.
    (3) Limitation on decision. When the amount of payment for the Part 
D drug is an issue before the ALJ or attorney adjudicator, the ALJ or 
attorney adjudicator may make a finding as to the amount of payment 
due. If the ALJ or attorney adjudicator makes a finding concerning 
payment when the amount of payment was not an issue before the ALJ or 
attorney adjudicator, the Part D plan sponsor may independently 
determine the payment amount. In either of the aforementioned 
situations, an ALJ's or attorney adjudicator's decision is not binding 
on the Part D plan sponsor for purposes of determining the amount of 
payment due. The amount of payment determined by the Part D plan 
sponsor in effectuating the ALJ's or attorney adjudicator's decision is 
a new coverage determination under Sec.  423.566.
    (b) Decisions on requests for review of an IRE dismissal--(1) 
General rule. Unless the ALJ or attorney adjudicator dismisses the 
request for review of an IRE dismissal, or the dismissal is vacated and 
remanded, the ALJ or attorney adjudicator will issue a written decision 
affirming the IRE's dismissal. OMHA mails or otherwise transmits a copy 
of the decision to the enrollee.
    (2) Content of the notice. The decision must be written in a manner 
calculated to be understood by an enrollee and must include--
    (i) The specific reasons for the determination, including a summary 
of the evidence considered and applicable authorities;
    (ii) The procedures for obtaining additional information concerning 
the decision; and
    (iii) Notification that the decision is binding and is not subject 
to further review, unless reopened and revised by the ALJ or attorney 
adjudicator.
    (c) Recommended decision. An ALJ or attorney adjudicator issues a 
recommended decision if he or she is directed to do so in the Council's 
remand order. An ALJ or attorney adjudicator may not issue a 
recommended decision on his or her own motion. The ALJ or attorney 
adjudicator mails a copy of the recommended decision to the enrollee at 
his or her last known address.
0
125. Section 423.2048 is revised to read as follows:


Sec.  423.2048  The effect of an ALJ's or attorney adjudicator's 
decision.

    (a) The decision of the ALJ or attorney adjudicator on a request 
for hearing is binding unless--
    (1) An enrollee requests a review of the decision by the Council 
within the stated time period or the Council reviews the decision 
issued by an ALJ or attorney adjudicator under the procedures set forth 
in Sec.  423.2110, and the Council issues a final decision or remand 
order;
    (2) The decision is reopened and revised by an ALJ or attorney 
adjudicator or the Council under the procedures explained in Sec.  
423.1980;
    (3) The expedited access to judicial review process at Sec.  
423.1990 is used;
    (4) The ALJ's or attorney adjudicator's decision is a recommended 
decision directed to the Council and the Council issues a decision; or
    (5) In a case remanded by a Federal district court, the Council 
assumes jurisdiction under the procedures in Sec.  423.2138 and the 
Council issues a decision.
    (b) The decision of the ALJ or attorney adjudicator on a request 
for review of an IRE dismissal is binding on the enrollee unless the 
decision is reopened and revised by the ALJ or attorney adjudicator 
under the procedures explained in Sec.  423.1980.


Sec.  423.2050  [Amended]

0
126. Section 423.2050 is amended by--
0
a. Amending the section heading by removing the phrase ``an ALJ'' and 
adding ``OMHA'' in its place.

[[Page 43887]]

0
b. Amending the text of the section by removing the phrase ``pending 
before an ALJ'' and adding ``pending before OMHA'' in its place, and by 
removing the term ``the ALJ'' and adding ``OMHA'' in its place.
0
c. Amending the section heading and the text of the section by removing 
the term ``MAC'' each time it appears and adding ``Council'' in its 
place.
0
127. Section 423.2052 is revised to read as follows:


Sec.  423.2052  Dismissal of a request for a hearing before an ALJ or 
request for review of an IRE dismissal.

    (a) Dismissal of request for hearing. An ALJ dismisses a request 
for a hearing under any of the following conditions:
    (1) Neither the enrollee that requested the hearing nor the 
enrollee's representative appears at the time and place set for the 
hearing, if--
    (i) The enrollee was notified before the time set for the hearing 
that the request for hearing might be dismissed for failure to appear, 
the record contains documentation that the enrollee acknowledged the 
notice of hearing, and the enrollee does not contact the ALJ within 10 
calendar days after the hearing for non-expedited hearings and 2 
calendar days after the hearing for expedited hearings, or does contact 
the ALJ but the ALJ determines the enrollee did not demonstrate good 
cause for not appearing; or
    (ii) The record does not contain documentation that the enrollee 
acknowledged the notice of hearing, the ALJ sends a notice to the 
enrollee at his or her last known address asking why the enrollee did 
not appear, and the enrollee does not respond to the ALJ's notice 
within 10 calendar days for non-expedited hearings or within 2 calendar 
days for expedited hearings after receiving the notice, or does contact 
the ALJ but the ALJ determines the enrollee did not demonstrate good 
cause for not appearing. For expedited hearings, an enrollee may submit 
his or her response orally to the ALJ.
    (iii) In determining whether good cause exists under paragraphs 
(a)(1)(i) and (ii) of this section, the ALJ considers any physical, 
mental, educational, or linguistic limitations (including any lack of 
facility with the English language) the enrollee may have.
    (2) The person requesting a hearing has no right to it under Sec.  
423.2002.
    (3) The enrollee did not request a hearing within the stated time 
period and the ALJ or attorney adjudicator has not found good cause for 
extending the deadline, as provided in Sec.  423.2014(e).
    (4) The enrollee died while the request for hearing is pending and 
the request for hearing was filed by the enrollee or the enrollee's 
representative, and the enrollee's surviving spouse or estate has no 
remaining financial interest in the case and the enrollee's 
representative, if any, does not wish to continue the appeal.
    (5) The ALJ or attorney adjudicator dismisses a hearing request 
entirely or refuses to consider any one or more of the issues because 
an IRE, an ALJ or attorney adjudicator, or the Council has made a 
previous determination or decision under this subpart about the 
enrollee's rights on the same facts and on the same issue(s), and this 
previous determination or decision has become binding by either 
administrative or judicial action.
    (6) The enrollee abandons the request for hearing. An ALJ or 
attorney adjudicator may conclude that an enrollee has abandoned a 
request for hearing when OMHA attempts to schedule a hearing and is 
unable to contact the enrollee after making reasonable efforts to do 
so.
    (7) The enrollee's request is not complete in accordance with Sec.  
423.2014(a)(1), even after the enrollee is provided with an opportunity 
to complete the request.
    (b) Dismissal of request for review of IRE dismissal. An ALJ or 
attorney adjudicator dismisses a request for review of an IRE dismissal 
under any of the following conditions:
    (1) The enrollee has no right to a review of the IRE dismissal 
under Sec.  423.2004.
    (2) The enrollee did not request a review within the stated time 
period and the ALJ or attorney adjudicator has not found good cause for 
extending the deadline, as provided in Sec.  423.2014(e).
    (3) The enrollee died while the request for review was pending and 
the request was filed by the enrollee or the enrollee's representative, 
and the enrollee's surviving spouse or estate has no remaining 
financial interest in the case and the enrollee's representative, if 
any, does not wish to continue the appeal.
    (4) The enrollee's request is not complete in accordance with Sec.  
423.2014(a)(1), even after the enrollee is provided with an opportunity 
to complete the request.
    (c) Withdrawal of request. At any time before notice of the 
decision, dismissal, or remand is mailed, if the enrollee asks to 
withdraw the request, an ALJ or attorney adjudicator may dismiss the 
request for hearing or request for review of an IRE dismissal. This 
request for withdrawal may be submitted in writing, or a request to 
withdraw a request for hearing may be made orally at a hearing before 
the ALJ. The request for withdrawal must include a clear statement that 
the enrollee is withdrawing the request for hearing or review of the 
IRE dismissal and does not intend to further proceed with the appeal. 
If an attorney or other legal professional on behalf of an enrollee 
files the request for withdrawal, the ALJ or attorney adjudicator may 
presume that the representative has advised the enrollee of the 
consequences of the withdrawal and dismissal.
    (d) Notice of dismissal. OMHA mails or otherwise transmits a 
written notice of the dismissal of the hearing or review request to the 
enrollee at his or her last known address. The written notice provides 
that there is a right to request that the ALJ or attorney adjudicator 
vacate the dismissal action.
    (e) Vacating a dismissal. If good and sufficient cause is 
established, the ALJ or attorney adjudicator may vacate his or her 
dismissal of a request for hearing or review within 6 months of the 
date of the notice of dismissal.
0
128. Section 423.2054 is revised to read as follows:


Sec.  423.2054  Effect of dismissal of a request for a hearing or 
request for review of an IRE's dismissal.

    (a) The dismissal of a request for a hearing is binding, unless it 
is vacated by the Council under Sec.  423.2108(b), or vacated by the 
ALJ or attorney adjudicator under Sec.  423.2052(e).
    (b) The dismissal of a request for review of an IRE dismissal of a 
request for reconsideration is binding and not subject to further 
review unless vacated by the ALJ or attorney adjudicator under Sec.  
423.2052(e).
0
129. Section 423.2056 is added to read as follows:


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

    (a) Missing appeal determination or case record. (1) If an ALJ or 
attorney adjudicator requests an official copy of a missing 
redetermination or reconsideration for an appealed coverage 
determination in accordance with Sec.  423.2034, and the IRE, CMS, or 
Part D plan sponsor does not furnish the copy within the time frame 
specified in Sec.  423.2034, an ALJ or attorney adjudicator may issue a 
remand directing the IRE or Part D plan sponsor to reconstruct the 
record or, if it is not able to do so, initiate a new appeal 
adjudication.
    (2) If the IRE does not furnish the case file for an appealed 
reconsideration, an ALJ or attorney adjudicator may issue a

[[Page 43888]]

remand directing the IRE to reconstruct the record or, if it is not 
able to do so, initiate a new appeal adjudication.
    (3) If the IRE or Part D plan sponsor is able to reconstruct the 
record for a remanded case and returns the case to OMHA, the case is no 
longer remanded and the reconsideration is no longer vacated, and any 
adjudication period that applies to the appeal in accordance with Sec.  
423.2016 is extended by the period between the date of the remand and 
the date that case is returned to OMHA.
    (b) No redetermination. If an ALJ or attorney adjudicator finds 
that the IRE issued a reconsideration and no redetermination was made 
with respect to the issue under appeal or the request for 
redetermination was dismissed, the reconsideration will be remanded to 
the IRE, or its successor, to re-adjudicate the request for 
reconsideration.
    (c) Requested remand--(1) Request contents and timing. At any time 
prior to an ALJ or attorney adjudicator issuing a decision or 
dismissal, the enrollee and CMS, the IRE, or the Part D plan sponsor 
may jointly request a remand of the appeal to the IRE. The request must 
include the reasons why the appeal should be remanded, and indicate 
whether remanding the case will likely resolve the matter in dispute.
    (2) Granting the request. An ALJ or attorney adjudicator may grant 
the request and issue a remand if he or she determines that remanding 
the case will likely resolve the matter in dispute.
    (d) Remanding an IRE's dismissal of a request for reconsideration. 
Consistent with Sec.  423.2004(b), an ALJ or attorney adjudicator will 
remand a case to the appropriate IRE if the ALJ or attorney adjudicator 
determines that an IRE's dismissal of a request for reconsideration was 
in error.
    (e) Consideration of change in condition. The ALJ or attorney 
adjudicator will remand a case to the appropriate IRE if the ALJ or 
attorney adjudicator determines that the enrollee wants evidence on his 
or her change in condition after the coverage determination to be 
considered in the appeal.
    (f) Notice of a remand. OMHA mails or otherwise transmits a written 
notice of the remand of the request for hearing or request for review 
to the enrollee at his or her last known address, and CMS, the IRE, 
and/or the Part D plan sponsor if a request to be a participant was 
granted by the ALJ or attorney adjudicator. The notice states that 
there is a right to request that the Chief ALJ or a designee review the 
remand.
    (g) Review of remand. Upon a request by the enrollee or CMS, the 
IRE, or the Part D plan sponsor filed within 30 calendar days of 
receiving a notice of remand, the Chief ALJ or designee will review the 
remand, and if the remand is not authorized by this section, vacate the 
remand order. The determination on a request to review a remand order 
is binding and not subject to further review.
0
130. Section 423.2058 is added to read as follows:


Sec.  423.2058  Effect of a remand.

    A remand of a request for hearing or request for review is binding 
unless vacated by the Chief ALJ or a designee in accordance with Sec.  
423.2056(g).


Sec.  423.2062  [Amended]

0
131. Section 423.2062 is amended by--
0
a. Amending the section heading and paragraphs (a) and (b) by removing 
the term ``MAC'' each time it appears and adding ``Council'' in its 
place.
0
b. Amending paragraph (a) by removing the term ``ALJs'' and adding 
``ALJs and attorney adjudicators'' in its place.
0
c. Amending paragraph (b) by removing the term ``ALJ'' each time it 
appears and adding ``ALJ or attorney adjudicator'' in its place.
0
132. Section 423.2063 is revised to read as follows:


Sec.  423.2063  Applicability of laws, regulations, CMS Rulings, and 
precedential decisions.

    (a) All laws and regulations pertaining to the Medicare program, 
including, but not limited to Titles XI, XVIII, and XIX of the Social 
Security Act and applicable implementing regulations, are binding on 
ALJs and attorney adjudicators, and the Council.
    (b) CMS Rulings are published under the authority of the CMS 
Administrator. Consistent with Sec.  401.108 of this chapter, rulings 
are binding on all CMS components, and on all HHS components that 
adjudicate matters under the jurisdiction of CMS.
    (c) Precedential decisions designated by the Chair of the 
Departmental Appeals Board in accordance with Sec.  401.109 of this 
chapter are binding on all CMS components, and all HHS components that 
adjudicate matters under the jurisdiction of CMS.
0
133. Section 423.2100 is revised to read as follows:


Sec.  423.2100  Medicare Appeals Council review: general.

    (a) Consistent with Sec.  423.1974, the enrollee may request that 
the Council review an ALJ's or attorney adjudicator's decision or 
dismissal.
    (b) When the Council reviews an ALJ's or attorney adjudicator's 
written decision, it undertakes a de novo review.
    (c) The Council issues a final decision, dismissal order, or 
remands a case to the ALJ or attorney adjudicator no later than the end 
of the 90 calendar day period beginning on the date the request for 
review is received (by the entity specified in the ALJ's or attorney 
adjudicator's written notice of decision), unless the 90 calendar day 
period is extended as provided in this subpart or the enrollee requests 
expedited Council review.
    (d) If an enrollee requests expedited Council review, the Council 
issues a final decision, dismissal order or remand as expeditiously as 
the enrollee's health condition requires, but no later than the end of 
the 10 calendar day period beginning on the date the request for review 
is received (by the entity specified in the ALJ's or attorney 
adjudicator's written notice of decision), unless the 10 calendar day 
period is extended as provided in this subpart.
0
134. Section 423.2102 is revised to read as follows:


Sec.  423.2102  Request for Council review when ALJ or attorney 
adjudicator issues decision or dismissal.

    (a)(1) An enrollee may request Council review of a decision or 
dismissal issued by an ALJ or attorney adjudicator if the enrollee 
files a written request for a Council review within 60 calendar days 
after receipt of the ALJ's or attorney adjudicator's written decision 
or dismissal.
    (2) An enrollee may request that Council review be expedited if the 
appeal involves an issue specified in Sec.  423.566(b) but does not 
include solely a request for payment of Part D drugs already furnished.
    (i) If an enrollee is requesting that the Council review be 
expedited, the enrollee submits an oral or written request within 60 
calendar days after the receipt of the ALJ's or attorney adjudicator's 
written decision or dismissal. A prescribing physician or other 
prescriber may provide oral or written support for an enrollee's 
request for expedited review.
    (ii) The Council must document all oral requests for expedited 
review in writing and maintain the documentation in the case files.
    (3) For purposes of this section, the date of receipt of the ALJ's 
or attorney adjudicator's written decision or dismissal is presumed to 
be 5 calendar days after the date of the notice of the decision or 
dismissal, unless there is evidence to the contrary.

[[Page 43889]]

    (4) The request is considered as filed on the date it is received 
by the entity specified in the notice of the ALJ's or attorney 
adjudicator's action.
    (b) An enrollee requesting a review may ask that the time for 
filing a request for Council review be extended if--
    (1) The request for an extension of time is in writing or, for 
expedited reviews, in writing or oral. The Council must document all 
oral requests in writing and maintain the documentation in the case 
file.
    (2) The request explains why the request for review was not filed 
within the stated time period. If the Council finds that there is good 
cause for missing the deadline, the time period will be extended. To 
determine whether good cause exists, the Council uses the standards 
outlined at Sec.  405.942(b)(2) and (3) of this chapter.
    (c) An enrollee does not have the right to seek Council review of 
an ALJ's or attorney adjudicator's remand to an IRE, or an ALJ's or 
attorney adjudicator's affirmation of an IRE's dismissal of a request 
for reconsideration, or dismissal of a request to review an IRE 
dismissal.


Sec.  423.2106  [Amended]

0
135. Section 423.2106 is amended by--
0
a. Removing the term ``ALJ'' and adding ``ALJ or attorney adjudicator'' 
in its place.
0
b. Removing the term ``ALJ's'' each time it appears and adding ``ALJ's 
or attorney adjudicator's'' in its place.
0
c. Removing the term ``MAC'' each time it appears and adding 
``Council'' in its place.
0
d. Removing the term ``MAC's'' and adding ``Council's'' in its place.


Sec.  423.2108  [Amended]

0
136. Section 423.2108 is amended by--
0
a. Amending paragraphs (a), (b), and (c) by removing the term ``ALJ'' 
and adding ``ALJ or attorney adjudicator'' in its place.
0
b. Amending paragraphs (a) and (d)(2)(iii) by removing the term 
``ALJ's'' each time it appears and adding ``ALJ's or attorney 
adjudicator's'' in its place.
0
c. Amending the section heading and paragraphs (a), (b), (c), (d)(1), 
(d)(2) introductory text, (d)(3) introductory text, and (d)(3)(ii) by 
removing the term ``MAC'' each time it appears and adding ``Council'' 
in its place.
0
d. Amending paragraph (a) by removing the term ``MAC's'' and adding 
``Council's'' in its place.
0
e. Amending the paragraph heading and text of paragraph (b) by removing 
the phrase ``ALJ's dismissal'' and adding ``ALJ's or attorney 
adjudicator's dismissal of a request for a hearing'' in its place.
0
137. Section 423.2110 is revised to read as follows:


Sec.  423.2110  Council reviews on its own motion.

    (a) General rule. The Council may decide on its own motion to 
review a decision or dismissal issued by an ALJ or attorney 
adjudicator. CMS or the IRE may refer a case to the Council for it to 
consider reviewing under this authority any time within 60 calendar 
days after the date of an ALJ's or attorney adjudicator's written 
decision or dismissal.
    (b) Referral of cases. (1) CMS or the IRE may refer a case to the 
Council if, in the view of CMS or the IRE, the decision or dismissal 
contains an error of law material to the outcome of the appeal or 
presents a broad policy or procedural issue that may affect the public 
interest. CMS or the IRE may also request that the Council take own 
motion review of a case if--
    (i) CMS or the IRE participated or requested to participate in the 
appeal at the OMHA level; and
    (ii) In CMS' or the IRE's view, the ALJ's or attorney adjudicator's 
decision or dismissal is not supported by the preponderance of evidence 
in the record or the ALJ or attorney adjudicator abused his or her 
discretion.
    (2) CMS' or the IRE's referral to the Council is made in writing 
and must be filed with the Council no later than 60 calendar days after 
the ALJ's or attorney adjudicator's written decision or dismissal is 
issued.
    (i) The written referral will state the reasons why CMS or the IRE 
believes that the Council should review the case on its own motion.
    (ii) CMS or the IRE will send a copy of its referral to the 
enrollee and to the OMHA Chief ALJ.
    (iii) The enrollee may file exceptions to the referral by 
submitting written comments to the Council within 20 calendar days of 
the referral notice.
    (iv) An enrollee submitting comments to the Council must send the 
comments to CMS or the IRE.
    (c) Standard of review--(1) Referral by CMS or the IRE when CMS or 
the IRE participated or requested to participate in the OMHA level. If 
CMS or the IRE participated or requested to participate in an appeal at 
the OMHA level, the Council exercises its own motion authority if there 
is an error of law material to the outcome of the case, an abuse of 
discretion by the ALJ or attorney adjudicator, the decision is not 
consistent with the preponderance of the evidence of record, or there 
is a broad policy or procedural issue that may affect the general 
public interest. In deciding whether to accept review under this 
standard, the Council will limit its consideration of the ALJ's or 
attorney adjudicator's action to those exceptions raised by CMS or the 
IRE.
    (2) Referral by CMS or the IRE when CMS or the IRE did not 
participate or request to participate in the OMHA proceedings. The 
Council will accept review if the decision or dismissal contains an 
error of law material to the outcome of the case or presents a broad 
policy or procedural issue that may affect the general public interest. 
In deciding whether to accept review, the Council will limit its 
consideration of the ALJ's or attorney adjudicator's action to those 
exceptions raised by CMS or the IRE.
    (d) Council's action. (1) If the Council decides to review a 
decision or dismissal on its own motion, it will mail the results of 
its action to the enrollee and to CMS or the IRE, as appropriate.
    (2) The Council may adopt, modify, or reverse the decision or 
dismissal, may remand the case to an ALJ or attorney adjudicator for 
further proceedings, or may dismiss a hearing request.
    (3) The Council must issue its action no later than 90 calendar 
days after receipt of the CMS or the IRE referral, unless the 90 
calendar day period has been extended as provided in this subpart.
    (4) The Council may not issue its action before the 20 calendar day 
comment period has expired, unless it determines that the agency's 
referral does not provide a basis for reviewing the case.
    (5) If the Council declines to review a decision or dismissal on 
its own motion, the ALJ's or attorney adjudicator's decision or 
dismissal is binding.


Sec.  423.2112  [Amended]

0
138. Section 423.2112 is amended by--
0
a. Amending paragraphs (a)(1), (b), and (c) by removing the term 
``ALJ's'' and adding ``ALJ's or attorney adjudicator's'' in its place.
0
b. Amending paragraph (b) by removing the term ``ALJ'' and adding ``ALJ 
or attorney adjudicator'' in its place.
0
c. Amending paragraphs (a)(1) and (3), and (c) by removing the term 
``MAC'' and adding ``Council'' in its place.


Sec.  423.2114  [Amended]

0
139. Section 423.2114 is amended in the introductory text and paragraph 
(b) by removing the term ``MAC'' each time it appears and adding 
``Council'' in its place.

[[Page 43890]]

Sec.  423.2116  [Amended]

0
140. Section 423.2116 is amended by--
0
a. Removing the term ``MAC'' each time it appears and adding 
``Council'' in its place.
0
b. Removing the term ``MAC's'' and adding ``Council's'' in its place.
0
c. Removing the term ``ALJ'' and adding ``ALJ or attorney adjudicator'' 
in its place.


Sec.  423.2118  [Amended]

0
141. Section 423.2118 is amended by--
0
a. Removing the term ``MAC'' each time it appears and adding 
``Council'' in its place.
0
b. Removing the term ``MAC's'' and adding ``Council's'' in its place.
0
c. Removing the phrase ``ALJ hearing'' and adding ``ALJ's or attorney 
adjudicator's action'' in its place.
0
d. Removing the phrase ``the exhibits list'' and adding ``any index of 
the administrative record'' in its place.
0
e. Removing the term ``CD'' and adding ``audio recording'' in its 
place.


Sec.  423.2120  [Amended]

0
142. Section 423.2120 is amended by removing the term ``MAC'' each time 
it appears and adding ``Council'' in its place.


Sec.  423.2122  [Amended]

0
143. Section 423.2122 is amended by--
0
a. Amending the section heading and paragraphs (a) paragraph heading, 
(a)(1), (2), and (3), (b) introductory text, (b)(1) and (2), and 
(c)(1), (2), (3), and (4) by removing the term ``MAC'' each time it 
appears and adding ``Council'' in its place.
0
b. Amending paragraphs (a) paragraph heading and (a)(1) by removing the 
term ``ALJ's'' and adding ``ALJ's or attorney adjudicator's'' in its 
place.
0
c. Amending paragraph (a)(1) by removing the term ``ALJ level'' and 
adding ``OMHA level'' in its place.
0
d. Amending paragraph (a)(1) by removing the term ``hearing decision'' 
and adding ``ALJ's or attorney adjudicator's decision'' in its place.
0
e. Amending paragraphs (a)(1) and (2) by removing the term ``ALJ'' and 
adding ``ALJ or attorney adjudicator'' in its place.
0
f. Amending paragraph (a)(2) by removing the term ``hearing record'' 
and adding ``administrative record'' in its place.
0
g. Amending paragraph (c)(3) by removing the term ``MAC's'' and adding 
``Council's'' in its place.


Sec.  423.2124  [Amended]

0
144. Section 423.2124 is amended in the introductory text and 
paragraphs (a), (b), (c), (d), and (e) by removing the term ``MAC'' 
each time it appears and adding ``Council'' in its place.


Sec.  423.2126  [Amended]

0
145. Section 423.2126 is amended by--
0
a. Amending the section heading and paragraphs (a) paragraph heading, 
(a)(1), (2), and (3), (a)(4) paragraph heading, (a)(4)(i) and (ii), 
(a)(5) paragraph heading, (a)(5)(i) and (ii), and (b) by removing the 
term ``MAC'' each time it appears and adding ``Council'' in its place.
0
b. Amending paragraphs (a) paragraph heading, (a)(1), (2), and (3), 
(a)(4) paragraph heading, and (a)(5)(ii) by removing the term ``ALJ'' 
each time it appears and adding ``ALJ or attorney adjudicator'' in its 
place.
0
c. Amending paragraph (a)(2) by removing the term ``MAC's and adding 
``Council's'' in its place.
0
d. Amending paragraph (a)(5)(ii) by adding ``if applicable'' after the 
word ``rehearing''.


Sec.  423.2128  [Amended]

0
146. Section 423.2128 is amended by--
0
a. Amending the section heading and paragraphs (a), (b), and (c) by 
removing the term ``MAC'' each time it appears and adding ``Council'' 
in its place.
0
b. Amending paragraph (a) by removing the term ``ALJ'' and adding ``ALJ 
or attorney adjudicator'' in its place.
0
c. Amending paragraph (b) by removing the phrase ``ALJ hearing 
decision'' and adding ``ALJ or attorney adjudicator decision'' in its 
place.


Sec.  423.2130  [Amended]

0
147. Section 423.2130 is amended in the section heading and text by 
removing the term ``MAC's'' each time it appears and adding 
``Council's'' in its place.


Sec.  423.2134  [Amended]

0
148. Section 423.2134 is amended in paragraphs (b)(3) and (c) by 
removing the term ``MAC'' and adding ``Council'' in its place.


Sec.  423.2136  [Amended]

0
149. Section 423.2136 is amended by--
0
a. Amending paragraphs (a) and (c)(3) by removing the term ``MAC'' and 
adding ``Council'' in its place.
0
b. Amending paragraph (c)(2) by removing the term ``MAC's'' and adding 
``Council's'' in its place.
0
c. Amending paragraph (c)(3) by removing the term ``ALJ'' and adding 
``ALJ or attorney adjudicator'' in its place.


Sec.  423.2138  [Amended]

0
150. Section 423.2138 is amended by--
0
a. Removing the term ``MAC'' each time it appears and adding 
``Council'' in its place.
0
b. Removing the term ``ALJ'' and adding ``ALJ or attorney adjudicator'' 
in its place.


Sec.  423.2140  [Amended]

0
151. Section 423.2140 is amended by--
0
a. Amending the section heading and paragraphs (a)(1), (2), and (3), 
(b)(1), (b)(2) introductory text, (b)(2)(ii), (b)(3) and (4), (c) 
paragraph heading, (c)(1), (3), and (4), and (d) by removing the term 
``MAC'' each time it appears and adding ``Council'' in its place.
0
b. Amending the section heading and paragraphs (a)(1), (2), and (3), 
(b) paragraph heading, (b)(1), (b)(2) introductory text, (b)(2)(i), 
(b)(3) and (4), (c)(1) and (4), and (d) by removing the term ``ALJ'' 
each time it appears and adding ``ALJ or attorney adjudicator'' in its 
place.
0
c. Amending paragraph (d) by removing the term ``ALJ's'' and adding 
``ALJ's or attorney adjudicator's'' in its place.

PART 478--RECONSIDERATIONS AND APPEALS

0
152. The authority citation for part 478 continues to read as follows:

    Authority: Secs. 1102 and 1871 of the Social Security Act (42 
U.S.C. 1302 and 1395hh).

0
153. Section 478.14(c)(2) is amended by removing the phrase ``part 405, 
subpart G of this chapter for determinations under Medicare Part A, and 
part 405, subpart H of this chapter for determinations under Medicare 
Part B'' and adding ``part 405, subpart I of this chapter for 
determinations under Medicare Part A and Part B'' in its place.
0
154. Section 478.40 is amended by revising paragraphs (a) and (c) to 
read as follows:


Sec.  478.40  Beneficiary's right to a hearing.

    (a) Amount in controversy. If the amount in controversy is at least 
$200, a beneficiary (but not a provider or practitioner) who is 
dissatisfied with a QIO reconsidered determination may request a 
hearing by an administrative law judge (ALJ) of the Office of Medicare 
Hearings and Appeals (OMHA).
* * * * *
    (c) Governing provisions. The provisions of subpart I of part 405 
of this chapter apply to hearings and appeals under this subpart unless 
they

[[Page 43891]]

are inconsistent with specific provisions in this subpart or implement 
statutory provisions that are not also applicable under section 1155 of 
the Social Security Act. References in subpart I to initial 
determinations made by a Medicare contractor and reconsiderations made 
by a QIC should be read to mean initial determinations and reconsidered 
determinations made by a QIO.
0
155. Section 478.42 is revised to read as follows:


Sec.  478.42  Submitting a request for a hearing.

    (a) Where to submit the written request. A beneficiary who wants to 
obtain a hearing under Sec.  478.40 must submit a written request to 
the OMHA office identified in the notice of the QIO reconsidered 
determination.
    (b) Time limit for submitting a request for a hearing. (1) The 
request for a hearing must be filed within 60 calendar days of receipt 
of the notice of the QIO reconsidered determination, unless the time is 
extended for good cause as provided in Sec.  478.22.
    (2) The date of receipt of the notice of the reconsidered 
determination is presumed to be 5 calendar days after the date on the 
notice, unless there is evidence to the contrary.
    (3) A request is considered filed on the date it is received by 
OMHA.
0
156. Section 478.44 is revised to read as follows:


Sec.  478.44  Determining the amount in controversy for a hearing.

    (a) After an individual appellant has submitted a request for a 
hearing, the ALJ or attorney adjudicator determines the amount in 
controversy in accordance with Sec.  405.1006(d) and (e) of this 
chapter. When two or more appellants submit a request for hearing, the 
ALJ or attorney adjudicator determines the amount in controversy in 
accordance with Sec.  405.1006(d) and (e) of this chapter.
    (b) If the ALJ or attorney adjudicator determines that the amount 
in controversy is less than $200, the ALJ, without holding a hearing, 
or attorney adjudicator notifies the parties that the parties have 15 
calendar days to submit additional evidence to prove that the amount in 
controversy is at least $200.
    (c) At the end of the 15-day period, if an ALJ determines that the 
amount in controversy is less than $200, the ALJ, without holding a 
hearing dismisses the request for a hearing without ruling on the 
substantive issues involved in the appeal and notifies the parties and 
the QIO that the QIO reconsidered determination is conclusive for 
Medicare payment purposes.
0
157. Section 478.46 is revised to read as follows:


Sec.  478.46  Medicare Appeals Council and judicial review.

    (a) The circumstances under which the Medicare Appeals Council 
(Council) will review an ALJ's or attorney adjudicator's decision or 
dismissal are the same as those set forth at Sec. Sec.  405.1102 
(``Request for Council review when ALJ or attorney adjudicator issues 
decision or dismissal'') and 405.1110 (``Council reviews on its own 
motion'') of this chapter.
    (b) If $2,000 or more is in controversy, a party may obtain 
judicial review of a Council decision, or an ALJ's or attorney 
adjudicator's decision if a request for review by the Council was 
denied, by filing a civil action under the Federal Rules of Civil 
Procedure within 60 days after the date the party received notice of 
the Council decision or denial.
0
158. Section 478.48 is amended by revising the section heading and 
paragraphs (b) and (c) to read as follows:


Sec.  478.48  Reopening and revision of a reconsidered determination or 
a decision.

* * * * *
    (b) ALJ or attorney adjudicator and Council Reopening--Applicable 
procedures. The ALJ or attorney adjudicator, or the Council, whichever 
made the decision, may reopen and revise the decision in accordance 
with the procedures set forth in Sec.  405.980 of this chapter, which 
concerns reopenings and revised decisions under subpart I of part 405 
of this chapter.
    (c) Fraud or similar abusive practice. A reconsidered 
determination, a review of a DRG change, or a decision of an ALJ or 
attorney adjudicator, or the Council may be reopened and revised at any 
time, if the reconsidered determination, review, or decision was 
obtained through fraud or a similar abusive practice that does not 
support a formal finding of fraud.

    Approved: June 8, 2016.
Sylvia Burwell,
Secretary, Department of Health and Human Services.
[FR Doc. 2016-15192 Filed 6-28-16; 4:15 pm]
BILLING CODE 4150-46-P