Proposed Rule: Medicare Program Application of Certain Appeals Provisions To The Medicare Prescription Drug Appeals Process

Monday,
March 17, 2008
Part III
Department of
Health and Human
Services
Centers for Medicare & Medicaid Services
42 CFR Part 423
Medicare Program; Application of Certain
Appeals Provisions to the Medicare
Prescription Drug Appeals Process;
Proposed Rule
pwalker on PROD1PC71 with PROPOSALS2
VerDate Aug<31>2005 16:41 Mar 14, 2008 Jkt 214001 PO 00000 Frm 00001 Fmt 4717 Sfmt 4717 E:\FR\FM\17MRP2.SGM 17MRP2
14342 Federal Register / Vol. 73, No. 52 / Monday, March 17, 2008 / Proposed Rules
DEPARTMENT OF HEALTH AND your written comments (one original they are received, generally beginning
HUMAN SERVICES and two copies) before the close of the approximately 3 weeks after publication
comment period to either of the of a document, at the headquarters of
Centers for Medicare & Medicaid following addresses: the Centers for Medicare & Medicaid
Services a. Room 445–G, Hubert H. Humphrey Services, 7500 Security Boulevard,
Building, 200 Independence Avenue, Baltimore, Maryland 21244, Monday
42 CFR Part 423 SW., Washington, DC 20201. through Friday of each week from 8:30
[CMS–4127–P] (Because access to the interior of the a.m. to 4 p.m. To schedule an
HHH Building is not readily available to appointment to view public comments,
RIN 0938–AO87 persons without Federal Government phone 1–800–743–3951.
identification, commenters are
Medicare Program; Application of Abbreviations
encouraged to leave their comments in
Certain Appeals Provisions to the Because of the many terms to which
the CMS drop slots located in the main
Medicare Prescription Drug Appeals we refer by abbreviation in this
lobby of the building. A stamp-in clock
Process proposed rule, we are listing these
is available for persons wishing to retain
AGENCY: Centers for Medicare & a proof of filing by stamping in and abbreviations and their corresponding
Medicaid Services (CMS), HHS. retaining an extra copy of the comments terms in alphabetical order below:
ACTION: Proposed rule. being filed.) ALJ Administrative Law Judge
b. 7500 Security Boulevard, CMS Centers for Medicare & Medicaid
SUMMARY: This rule proposes the Baltimore, MD 21244–1850. Services
procedures that the Department of If you intend to deliver your DAB Departmental Appeals Board
Health and Human Services would comments to the Baltimore address, EAJR Expedited Access to Judicial Review
follow at the Administrative Law Judge please call telephone number (410) 786– IRE Independent Review Entity
and Medicare Appeals Council levels in 9994 in advance to schedule your LCD Local Coverage Determination
deciding appeals brought by individuals MAC Medicare Appeals Council
arrival with one of our staff members.
who have enrolled in the Medicare NCD National Coverage Determination
Comments mailed to the addresses QIC Qualified Independent Contractor
prescription drug benefit program and indicated as appropriate for hand or
the reopening procedures that would be courier delivery may be delayed and I. Background
followed at all levels of appeal. received after the comment period. For [If you choose to comment on issues
DATES: To be assured consideration, information on viewing public in this section, please include the
comments must be received at one of comments, see the beginning of the caption ‘‘BACKGROUND’’ at the
the addresses provided below, no later SUPPLEMENTARY INFORMATION section. beginning of your comments.]
than 5 p.m. on May 16, 2008. FOR FURTHER INFORMATION CONTACT: The voluntary prescription drug
ADDRESSES: In commenting, please refer Arrah Tabe-Bedward, (410) 786–7129 benefit program (‘‘Part D’’) was enacted
to file code CMS–4127–P. Because of (for issues related to reopenings and into law by section 101 of Title I of the
staff and resource limitations, we cannot expedited access to judicial review). Medicare Prescription Drug,
accept comments by facsimile (FAX) Michael Lipinski, (216) 615–4084 (for Improvement, and Modernization Act of
transmission. issues related to ALJ level appeals 2003 (MMA) (Pub. L. 108–173). The
You may submit comments in one of policies). MMA specified that the prescription
four ways (please choose only one of the Mary Peltzer, (202) 565–0169 (for drug benefit would become available on
ways listed): issues related to MAC level appeals).
1. Electronically. You may submit January 1, 2006 for individuals entitled
electronic comments on this regulation SUPPLEMENTARY INFORMATION: to benefits under Medicare Part A or
to http://www.regulations.gov. Follow Submitting Comments: We welcome enrolled under Medicare Part B. On
the instructions for ‘‘Comment or comments from the public on all issues January 28, 2005, the final rule (70 FR
Submission’’ and enter the filecode to set forth in this rule to assist us in fully 4194) implementing the Part D program
find the document accepting comments. considering issues and developing appeared in the Federal Register
2. By regular mail. You may mail policies. You can assist us by (hereinafter ‘‘Part D rule’’). This rule
written comments (one original and two referencing the file code 4127–P and the became effective on March 22, 2005.
copies) to the following address ONLY: specific ‘‘issue identifier’’ that precedes Section 1860D–4(h) of the Social
Centers for Medicare & Medicaid the section on which you choose to Security Act (the Act) provides that Part
Services, Department of Health and comment. D plan sponsors follow appeals
Human Services, Attention: Inspection of Public Comments: All procedures specified in § 1852(g)(5) of
CMS–4127–P, P.O. Box 8016, Baltimore, comments received before the close of the Act in a manner similar to the
MD 21244–8016. the comment period are available for manner such requirements apply to
Please allow sufficient time for mailed viewing by the public, including any Medicare Advantage (MA) organizations
comments to be received before the personally identifiable or confidential for Part C appeals. Part D plan sponsors
close of the comment period. business information that is included in include a prescription drug plan
3. By express or overnight mail. You a comment. We post all comments sponsor, an MA organization offering a
may send written comments (one received before the close of the Medicare Advantage prescription drug
original and two copies) to the following comment period on the following Web plan (MA–PD plan), a Program of All-
address ONLY: Centers for Medicare & site as soon as possible after they have Inclusive Care for Elderly (PACE)
Medicaid Services, Department of been received: http://www.cms.hhs.gov/ organization offering a PACE plan, and
Health and Human Services, Attention: eRulemaking. Click on the link a cost plan offering qualified
CMS–4127–P, Mail Stop C4–26–05, ‘‘Electronic Comments on CMS prescription drug coverage.
7500 Security Boulevard, Baltimore, MD Regulations’’ on that Web site to view Section 1852(g)(5) of the Act provides
21244–1850. public comments. that enrollees in MA plans who are
4. By hand or courier. If you prefer, Comments received timely will also dissatisfied with determinations
you may deliver (by hand or courier) be available for public inspection as regarding their Part C benefits are
Federal Register / Vol. 73, No. 52 / Monday, March 17, 2008 / Proposed Rules 14343
entitled, if they meet the amount in procedures specified in 42 CFR part 405 regulation easier to read and
controversy requirement, to a hearing ‘‘to the extent they are appropriate.’’ understand. Specifically, we are
before the Secretary to the same extent (see 42 CFR 422.562(d)). proposing to rename subpart M,
as is provided in section 205(b) of the Based on this statutory and regulatory ‘‘Grievances, Coverage Determinations,
Act and judicial review of the framework, CMS stated in the preamble Redeterminations, and
Secretary’s final decision as provided in to the interim final rule entitled Reconsiderations’’. This subpart will
section 205(g) of the Act. ‘‘Changes to the Medicare Claims continue to set forth the requirements
Section 1869(b)(1)(A) of the Act, Appeal Procedures,’’ which established for Part D sponsors with respect to
which sets forth the requirements for new procedures for appeals under grievances, coverage determinations,
Part A and Part B appeals, contains Medicare Part A and Part B, that and redeterminations. We are also
similar language to that set forth in differences in the appeals procedures proposing to add a new subpart U,
section 1852(g)(5) of the Act and also for Part D enrollees would be addressed ‘‘Reopenings, ALJ Hearings, MAC
refers to section 205(b) and (g) of the in a future Part D rulemaking document review, and Judicial Review’’ that will
Act. (70 FR 11420), (hereinafter, ‘‘Part 405, set forth the requirements for Part D
These statutory concepts are reflected subpart I rule’’). The purpose of this rule plan sponsors, the Part D Independent
in the Part D rule and a closely related is to provide guidance on the Review Entity (IRE), ALJs, and the MAC
rule concerning MA organizations that differences in appeals procedures for with respect to reopenings, ALJ
also appeared in the Federal Register on Part D enrollees by proposing more hearings, and MAC review of Part D
January 28, 2005 (70 FR 4588), and detailed regulations to govern Part D appeals. In addition, we are proposing
became effective March 22, 2005 appeals (requests for drug benefits and to redesignate and reserve § 423.610,
(hereinafter ‘‘Part C rule’’). The Part D payment) to the ALJ, MAC, and Federal § 423.612, § 423.620, § 423.630, and
rule is codified at 42 CFR part 423, and District Court and reopenings of § 423.634. We note that while we are
addresses grievances, coverage determinations and decisions. proposing to make conforming changes
determinations, reconsiderations, and to the language of some of the
II. Highlights and Organization of the
appeals in subpart M. The Part C rule is redesignated sections, we are not
Proposed Rule
codified at 42 CFR part 422, and proposing to make any substantive
similarly addresses grievances, [If you choose to comment on issues changes to the policies established by
organization determinations, and in this section, please include the those provisions.
appeals in subpart M. The Part D rule caption ‘‘HIGHLIGHTS AND Below we are providing a crosswalk
states that, unless otherwise provided, ORGANIZATION’’ at the beginning of table that will enable the reader to easily
the Part C rules regarding appeals and your comments.] determine where the requirements will
reopenings will apply ‘‘to the extent This proposed rule contains revisions be relocated. The crosswalk lists the
they are appropriate.’’ (See 42 CFR to Part 423, subpart M of title 42 of the current subpart, current section,
423.562(c).) Likewise, the Part C rule CFR. We are proposing to rename, proposed subpart, and proposed section.
governing appeals at the Administrative reorganize, and consolidate similar For any discussion of the changes we
Law Judge (ALJ) and Medicare Appeals requirements into one section, and add are proposing to make in this rule, we
Council (MAC) levels of appeal provides a new subpart ‘‘U’’. We believe that are providing both the current section
that adjudicators apply the Part A and these changes will maintain or clarify and the proposed redesignated section
Part B appeals and reopening our original intent, making the revised and paragraph.
TABLE—CROSSWALK
Current subpart Current section Proposed subpart Proposed section
Subpart M—Grievances, Coverage 423.610 Right to an ALJ hearing Subpart U—Reopening, ALJ 423.1970 Right to an ALJ hear-
Determinations, and Appeals. Hearings, MAC review, and Ju- ing.
dicial Review.
Subpart M—Grievances, Coverage 423.612 Request for an ALJ Subpart U—Reopening, ALJ 423.1972 Request for an ALJ
Determinations, and Appeals. hearing. Hearings, MAC review, and Ju- hearing.
dicial Review.
Subpart M—Grievances, Coverage 423.620 Medicare Appeals Subpart U—Reopening, ALJ 423.1974 Medicare Appeals
Determinations, and Appeals. Council (MAC) review. Hearings, MAC review, and Ju- Council (MAC) review.
dicial Review.
Subpart M—Grievances, Coverage 43.630 Judicial review ................ Subpart U—Reopening, ALJ 423.1976 Judicial review.
Determinations, and Appeals. Hearings, MAC review, and Ju-
dicial Review.
Subpart M—Grievances, Coverage 423.634 Reopening and revising Subpart U—Reopening, ALJ 423.1978 Reopening and revis-
Determinations, and Appeals. determinations and decisions. Hearings, MAC review, and Ju- ing determinations and deci-
dicial Review. sions.
III. Provisions of the Proposed Section 1860D–4(h)(1) of the Act, provides the right to a hearing ‘‘before
Regulations which sets forth the statutory the Secretary to the same extent as is
A. General Appeals Provisions requirements for Part D appeals, provided in section 205(b) of the Act,’’
requires the Secretary to establish an and to judicial review ‘‘of the
[If you choose to comment on issues appeals process that is ‘‘similar’’ to the Secretary’s final decision as provided in
in this section, please include the process used for MA organizations section 205(g)’’ of the Act. Thus, an
caption ‘‘GENERAL APPEALS under section 1852(g)(4) and (5) of the enrollee dissatisfied by reason of the
PROVISIONS’’ at the beginning of your Act. Section 1852(g)(5) of the Act enrollee’s failure to receive a Part D
comments.]
drug to which the enrollee believes he contains the new BIPA and MMA an enrollee may appoint a
or she is entitled, and at no greater appeals procedures. Part 405, subpart I, representative to act on his or her behalf
charge than the enrollee believes he or applies to initial determinations issued as discussed in § 423.560 and as set
she is required to pay is entitled to a by Medicare fiscal intermediaries on or forth in § 422.561 and § 405.910. A
hearing and may also request judicial after May 1, 2005, and to initial representative could include an
review of the final decision of the determinations issued by carriers on or enrollee’s physician).
Secretary. after January 1, 2006. Part 405, subpart We are proposing not to make the Part
Section 1852(g)(5) of the Act also I, is tailored to the Medicare Part A and D plan sponsor, the IRE, or CMS a party
specifies the amount in controversy Part B claims appeals process, unlike to an ALJ hearing or the MAC review in
needed to pursue a hearing and judicial the provisions in subparts G and H, a Part D case. The statute and Part D rule
review. Like section 1852(g)(5) of the which, in large part, follow the Social do not explicitly provide these entities
Act, section 1869(b)(1)(A) of the Act, Security Administration’s procedures with party status, unlike Part C where
which sets forth the statutory for disability claims. For this reason, we the statute provides that the Secretary
requirements for Part A and Part B have concluded that it is appropriate to shall make an MA organization a party
appeals, provides the right to a hearing apply the provisions of Part 405, subpart to ALJ hearings. Further, the preamble
‘‘by the Secretary to the same extent as I, to Part D appeals at the ALJ and MAC to the Part D rule (70 FR 4360) states
is provided in section 205(b)’’ and the levels with appropriate modifications to that ‘‘[t]he plan is not a party to the ALJ
right to judicial review ‘‘of the meet the needs of Part D appeals. hearing.’’ As discussed later in the
Secretary’s final decision after such preamble, we recognize that the
hearing as is provided in section 205(g) B. Parties to the ALJ Hearing and MAC involvement of CMS, the IRE, and/or the
of the Act.’’ Under this authority, we Review Part D plan sponsor may be necessary to
believe that Congress gave us discretion Section 1860D–4(h) of the Act largely resolve the issue(s) on appeal and we
in designing procedural rules for incorporates section 1852(g)(5) of the propose to allow these entities to
appeals under Part D. Act. We interpret that section as participate in ALJ hearings at the ALJ’s
Section 423.562(c) of the Part D rule providing the right to a hearing and to discretion. The participation of Part D
states that ‘‘[u]nless this subpart judicial review for an enrollee plan sponsors in ALJ hearings was also
provides otherwise, the regulations in dissatisfied by reason of the enrollee’s contemplated in the preamble to the
part 422, subpart M of this chapter failure to receive a Part D drug to which proposed Part D rule (69 FR 46632,
(concerning administrative review and the enrollee believes he or she is 46722), which noted that ‘‘[a]lthough a
hearing processes under titles II and entitled, and at no greater charge than PDP sponsor generally is not a party to
XVIII, and representation of parties the enrollee believes he or she is the IRE appeal and may not request a
under title XVIII of the Act) and any required to pay. Section 1860D–4(h)(1) hearing before an ALJ, the sponsor is
interpretive rules or CMS rulings issued of the Act specifies that ‘‘only the Part considered a party to the ALJ hearing for
under these regulations, apply under D eligible individual’’ is entitled to the limited purpose of participation in
this subpart to the extent they are bring an appeal. Section 423.560 of the the hearing.’’ We welcome comments on
appropriate.’’ Section 422.562(d) of the Part D rule states that an enrollee is a this proposed approach.
Part C rule states that ‘‘[u]nless this Part D eligible individual who has
subpart provides otherwise, the elected or has been enrolled in a Part D C. Timeframes for Deciding Appeals at
regulations in part 405 of this chapter plan. the ALJ and MAC Levels
(concerning the administrative review Current § 423.610 (proposed [If you choose to comment on issues
and hearing processes and § 423.1970) and current § 423.612 in this section, please include the
representation of parties under titles II (proposed § 423.1972) explain that, if an caption ‘‘TIMEFRAMES FOR DECIDING
and XVIII of the Act), apply under this enrollee is dissatisfied with the APPEALS AT THE ALJ AND MAC
subpart to the extent they are reconsideration determination by an LEVELS’’ at the beginning of your
appropriate.’’ Therefore, as discussed in IRE, the enrollee may request a hearing comments.]
the preamble to the Part D rule, since before an ALJ, if the amount remaining Part 405, subpart I implements the
§ 423.562(c) incorporates part 422, and in controversy meets the threshold provisions of section 1869 of the Act
since part 422 incorporates part 405, the requirement established annually by the that require ALJs and the MAC to
provisions of part 405 apply to Part D Secretary. Similarly, under current complete their actions within 90 days of
appeals to the extent that they are § 423.620 (proposed § 423.1974), if an the date an appeal is timely filed. The
appropriate. (70 FR at 4343). enrollee is dissatisfied with the ALJ’s Part D statute and rule do not establish
For these reasons, we propose to action, the enrollee may request that the timeframes for an ALJ or the MAC to
provide a similar appeals process for MAC review the ALJ’s decision or issue a decision. However, we recognize
Part D appeals at the ALJ, MAC and dismissal. Having the enrollee as the the need to ensure that Part D enrollees
judicial review levels as applies to Part only party to an appeal differs from the receive timely actions on their requests
A and Part B appeals, to the extent it is Part A and B processes where the term for hearing and review, particularly in
appropriate. ‘‘party’’ includes a beneficiary, a cases where the enrollee has not
The Part 405 regulations at subparts G provider, a supplier, a Medicaid State obtained the drug and a delayed
and H, which continue to apply to agency, and CMS and/or its contractors, decision may seriously jeopardize the
certain pending Medicare claims and from the Part C appeals process enrollee’s life or health or ability to
appeals under Medicare Part A and Part where the term ‘‘party’’ includes an regain maximum function.
B, respectively, were issued before the enrollee, a provider, an entity with We propose to apply a 90-day
enactment of the Medicare, Medicaid, rights with respect to the organization adjudicatory timeframe to Part D
and SCHIP Benefits Improvement and determination, or an MA organization. appeals with an expedited process for
Protection Act of 2000 (BIPA), Pub. L. In light of the Part D statutory and certain types of appeals. Specifically,
106–554. BIPA made significant changes regulatory provisions, this proposed we propose that an ALJ and the MAC
to Medicare claims appeals procedures. rule makes clear that only the enrollee must provide an expedited decision in
The MMA made further changes to may request and be a party to an ALJ situations where the appeal involves
these procedures. Part 405, subpart I, hearing or MAC review. (We note that one of the issues specified in
§ 423.566(b), but does not include solely evidence about his or her condition at beneficiaries represented by providers
a request for payment of Part D drugs the time of the coverage determination or suppliers in an effort to ensure that
already furnished, and when the that he or she wishes to have considered providers or suppliers do not attempt to
enrollee’s prescribing physician at the hearing. However, we propose circumvent the full and early
indicates, or the ALJ or the MAC where an enrollee wishes to have presentation of evidence rules by
determines that applying the standard evidence on changes in his or her offering to represent beneficiaries. For
timeframe for making a decision may condition since the coverage Part D appeals, we propose that only the
seriously jeopardize the enrollee’s life or determination considered in the appeal, enrollee would be a party to the appeal
health or ability to regain maximum an ALJ or the MAC will instead remand and because the enrollee would not be
function. In these situations, the ALJ the case to the Part D plan sponsor. The represented by a provider or supplier
and the MAC must issue a decision, Part D plan sponsor is in a better attempting to circumvent this rule we
dismissal order, or remand as position to evaluate the impact of propose to not include any provisions
expeditiously as the enrollee’s health evidence on change in condition from Part 405, subpart I, on the full and
condition requires, but no later than the because it has the technical expertise early presentation of evidence. We
end of the 10-day period beginning on needed to review such evidence. This propose, as discussed above, that an
the date the request for hearing or proposal differs from the Part 405, enrollee may present new evidence at
request for review is received. subpart I, rule, because Part A and Part any time during the appeal. However,
This process is similar to the B appeals are retrospective; that is, the we propose that the ALJ or MAC will
expedited process established at the service or item at issue was provided or not consider evidence on change in
coverage determination, received before the claim is filed. In condition occurring after the coverage
redetermination, and reconsideration these situations, evidence of medical determination is made but will remand
levels under the Part D rule at § 423.570, necessity is not relevant unless it relates the appeal to the Part D plan sponsor if
§ 423.584, and § 423.600. As discussed to the beneficiary’s medical condition an enrollee wishes to have such
in applicable sections below, in order to and needs at the time that the evidence examined and considered in
meet this shortened timeframe, we beneficiary received the service or the appeal.
propose to allow certain requests, obtained the medical product or device.
objections, decisions, orders, and In contrast, some Part D appeals involve E. Claims and Overpayment
notices to be conducted orally with an enrollee requesting that the Part D [If you choose to comment on issues
written follow-up or documentation and plan sponsor provide him or her with a in this section, please include the
to shorten certain timeframes for particular drug (‘‘drug benefit appeals’’). caption ‘‘CLAIMS AND
receiving certain notices, such as the In these cases, the enrollee’s condition OVERPAYMENT’’ at the beginning of
notice of hearing. All time periods in may change during the course of the your comments.]
this proposed rule refer to calendar appeal, and evidence of such a change The Part A and Part B appeals process
days. in condition may impact a Part D plan
The statutory and regulatory may involve claims for reimbursement
sponsor’s determination regarding from the Medicare Trust Fund made by
provisions for appeals under Parts A whether the enrollee should receive a
and B provide appellants the parties to the appeal and issues of over-
certain Part D drug.
opportunity to request that the appeal or underpayment by the Federal
We considered allowing an enrollee
be transferred (or ‘‘escalated’’) to the Government. In contrast, Part D appeals
in such circumstances to withdraw a
next level of appeal, if the Qualified pending appeal and seek a new coverage do not involve claims against the
Independent Contractor (QIC), ALJ, or determination from the Part D plan Medicare Trust Fund by enrollees, and,
the MAC do not complete their actions sponsor. However, we believe a remand therefore, the Part D appeals process
within the statutory deadlines. The Part would streamline the process for the does not involve overpayments or
C and D statutory provisions do not enrollee by eliminating the need for the underpayments. Rather, an enrollee may
provide for escalation of an appeal to enrollee to both withdraw a pending request payment from the Part D plan
the ALJ, MAC, or Federal District Court appeal and to file a new coverage sponsor in situations where the enrollee
levels. We propose to not include determination request. Additionally, on has paid for a drug out-of-pocket
provisions regarding escalation in this remand the Part D plan sponsor would (‘‘payment appeals’’). Therefore, we do
rule, but instead we are proposing to have access to an already developed not include any references to claims,
address the timeliness concerns of Part case file when reviewing newly overpayment, or underpayment in this
D enrollees by providing for an submitted evidence on change in proposed rule.
expedited process, discussed in greater condition, allowing for a more efficient F. Other General Comments
detail below. and effective review by reducing
possible delays from developing a new [If you choose to comment on issues
D. Evidence case file. We also note that under our in this section, please include the
[If you choose to comment on issues proposal, the enrollee would have the caption ‘‘OTHER GENERAL
in this section, please include the option to continue with his or her COMMENTS’’ at the beginning of your
caption ‘‘EVIDENCE’’ at the beginning appeal at the ALJ or MAC level if he or comments.]
of your comments.] she did not wish to have change in The Part D rule already contains
We are proposing to provide enrollees condition evidence considered. provisions in current § 423.610
with as much flexibility as possible We do not propose to follow the full (proposed § 423.1970), current § 423.612
concerning the evidence that may be and early presentation of evidence (proposed § 423.1972), and current
presented for an ALJ hearing and MAC provisions in Part 405, subpart I, § 423.630 (proposed § 423.1976)
review. We also are proposing that the including § 405.1028. Section 1869(b)(3) regarding the amount in controversy
entity that is best suited to review and of the Act requires the full and early requirements for ALJ hearings and
evaluate the evidence be the entity that presentation of evidence at the judicial review. Therefore, we see no
receives the evidence for review. reconsideration level by providers and reason to include language similar to
Therefore, we are proposing that an suppliers absent good cause. Part 405, that in § 405.990(j) and § 405.1006
enrollee may submit any written subpart I, extends this requirement to regarding amount in controversy
requirements for Part A and Part B Part 405, subpart I with additional DETERMINATION OR DECISION’’ at
appeals. language proposed at § 423.1980(a)(1), the beginning of your comments.]
Part 405, subpart I, references the (a)(3), and (a)(4), and § 423.1984(g) that We are proposing in § 423.1982 to
applicability of national coverage is consistent with current § 423.634 follow the process established for Part A
determinations (NCDs) and local (proposed § 423.1978) on Part D and Part B reopenings regarding
coverage determinations (LCDs). reopenings. Since Part D appeals differ notification of revised determinations or
Because neither of these types of in part from Part A and Part B appeals, decisions. However, unlike § 405.982,
coverage policies applies to Part D, we we propose not to include several proposed § 423.1982 does not refer to
propose not to include any reference to provisions from § 405.980, § 405.982, revised electronic or paper remittance
NCDs and LCDs and not to include any and § 405.986. for full or partial reversals. We are not
provision that applies solely to the incorporating this language because
1. Reopenings of Coverage revised electronic or paper remittance
application of NCDs and/or LCDs from Determinations, Redeterminations,
Part 405, subpart I (for example, advice notices are not issued for Part D
Reconsiderations, Hearings, and appeals. Further, we propose language
language from § 405.1060). Reviews (§ 423.1980)
Part 405, subpart I, also refers to the requiring the IRE, ALJ, or the MAC to
Social Security Administration (SSA) [If you choose to comment on issues mail revised determinations or
rules for entitlement and enrollment in this section, please include the decisions to the Part D plan sponsor.
appeals performed by SSA. We are not caption ‘‘REOPENINGS OF COVERAGE
DETERMINATIONS, 3. Good Cause for Reopening
including similar references to SSA in (§ 423.1986)
this proposed rule because SSA does REDETERMINATIONS,
not perform appeals regarding RECONSIDERATIONS, HEARINGS, [If you choose to comment on issues
enrollment in or entitlement to Part D. AND REVIEWS’’ at the beginning of in this section, please include the
Finally, Part 405, subpart I includes a your comments.] caption ‘‘GOOD CAUSE FOR
provision at § 405.1064 regarding ALJ This section proposes to track the REOPENING’’ at the beginning of your
decisions involving statistical samples. language of § 405.980 on the general comments.]
We are not including similar language rules and timeframes for reopening Section 423.1986 proposes language
for Part D appeals because, as discussed determinations and decisions, except as similar to § 405.986 regarding good
above, Part D appeals do not involve discussed above and below. We are cause for reopening a determination or
overpayment issues. Therefore, proposing to define reopenings in decision. We believe it is appropriate
statistical samples will not be used in § 423.1980(a)(1), without referring to where possible for Part D reopenings to
reaching a decision. overpayments and underpayments have the same good cause standards as
because these terms do not apply to Part Part A and Part B reopenings. We are
IV. Specific Provisions of the Proposed D appeals, as discussed above. We also proposing in § 423.1986(b)(1), to include
Rule are proposing in § 423.1980 not to the requirement in § 405.986(b)
A. Reopenings (§ 423.1980 Through include the provision in § 405.980(a)(2) regarding good cause for reopening a
§ 423.1986) that involves situations where a fiscal determination or decision based on a
intermediary or carrier denies a claim change in substantive law or
[If you choose to comment on issues because it did not receive information interpretive policy for appeals.
in this section, please include the that it requested about a claim during However, many Part D appeals involve
caption ‘‘REOPENINGS’’ at the medical review. In addition, we are drug benefit appeals, where an enrollee
beginning of your comments.] proposing not to include § 405.980(a)(3), has not received the drug. With respect
Current § 423.634(a) (proposed (b)(4), and (c)(3) in this proposed rule. to these appeals, we are proposing in
§ 423.1978(a)) states that a coverage These subsections refer to clerical errors § 423.1986(b)(2) that an adjudicator may
determination, a redetermination, a related to claim submissions by reopen a determination or decision to
reconsideration or a decision of an ALJ providers to fiscal intermediaries and apply the current law or CMS or Part D
or the MAC ‘‘that is otherwise final and carriers. In Part D, as discussed above, plan sponsor policy (rather than the law
binding may be reopened and revised by there are no claim submissions, as the or CMS or Part D plan sponsor policy at
the entity that made the determination beneficiary is not electronically the time the original coverage
or decision, under the rules in part 422, submitting a claim to the Part D plan determination was made). Because the
subpart M of this chapter.’’ Section sponsor or to CMS. Therefore, we do not enrollee has not received the drug, any
422.616 of subpart M discusses believe these provisions apply to Part D change to the law or CMS or Part D plan
reopenings and states that a reopenings. Further, to the extent a sponsor policies since the initial
determination or decision ‘‘that is clerical error arises (for example, coverage determination may affect
otherwise final and binding may be miscalculations or missing information), whether the drug should be received.
reopened and revised by the entity that an enrollee should use the grievance
made the determination or decision, B. Expedited Access to Judicial Review
process established by the Part D plan
under the rules in part 405 of this (EAJR) (§ 423.990)
sponsor.
chapter.’’ Therefore, we propose Furthermore, we are not including in [If you choose to comment on issues
reopening regulations that generally § 423.1980 language similar to in this section, please include the
track the Part A and Part B reopening § 405.980(b)(5) because this provision caption ‘‘EXPEDITED ACCESS TO
provisions in § 405.980, § 405.982, refers to the NCD/LCD appeals process, JUDICIAL REVIEW’’ at the beginning of
§ 405.984, and § 405.986. These and NCDs and LCDs do not apply to your comments.]
regulations define reopening, explain Section 1869(b)(2) of the Act requires
Part D.
who may initiate and revise the Secretary to establish a process for
determinations and decisions and when, 2. Notice of a Revised Determination or Part A and Part B appeals where a
and the effect of a revised determination Decision (§ 423.1982) provider, supplier or a beneficiary may
or decision. [If you choose to comment on issues obtain expedited access to judicial
We believe that it is appropriate to in this section, please include the review in situations where the
follow the general process set forth in caption ‘‘NOTICE OF A REVISED Departmental Appeals Board (DAB)
does not have authority to decide the language in the Part 405 rule for expedited process provided at the lower
question of law or regulation relevant to proposed § 423.2000, § 423.2004, levels of appeal would benefit enrollees
the matters in controversy and where § 423.2008, § 423.2030, § 423.2032, who need quick decisions about Part D
there is no material issue of fact in § 423.2042, § 423.2044, § 423.2048, drugs due to their health status. We
dispute. § 423.2050, § 423.2054, § 423.2062, and propose at § 423.2002(b)(3) a more
Unlike Part A and Part B appeals, § 423.2063. We believe that it is informal process for requesting an
there is no statutory requirement for appropriate for Part D appeals to follow expedited hearing by proposing to
enrollees to have access to an EAJR the Part A and Part B appeals permit an enrollee to make a request for
process for Part D appeals. However, we procedures set forth in these provisions. hearing orally. We believe that the oral
believe that it is appropriate to provide request would make the initiation of the
Part D enrollees with an EAJR process 2. Right to an ALJ Hearing (§ 423.2002)
ALJ appeals process faster and easier for
that mirrors the process established for [If you choose to comment on issues the enrollee. However, for the reasons
Part A and Part B appeals. Under the in this section, please include the stated above, an enrollee may only file
Part A and Part B appeal process, a caption ‘‘RIGHT TO AN ALJ HEARING’’ an oral request for an expedited hearing
review entity determines whether the at the beginning of your comments.] after receiving the written IRE
DAB has the authority to decide the The Part D rule currently at reconsideration notice. We also are
question of law or regulation relevant to § 423.610(a) (proposed § 423.1970(a)) proposing in § 423.2002(b)(4), to require
the matters in controversy after finding provides that an enrollee who is the ALJ hearing office to document and
that there is no material issue of fact in dissatisfied with the IRE reconsideration maintain documentation of any oral
dispute. and meets the remaining amount in request.
If the review entity certifies that the controversy threshold has a right to a
requirements for expedited access to hearing before an ALJ. We are proposing 3. Participation in an ALJ Hearing
judicial review are met, a party may to include this provision in § 423.2002. (§ 423.2010)
appeal directly to the United States We are also proposing to include in this [If you choose to comment on issues
District Court. Even though the Part D section language similar to that in in this section, please include the
statute does not require this process for § 405.1002 on how to request an ALJ caption ‘‘PARTICIPATION IN AN ALJ
Part D, we believe that Part D enrollees hearing, what is the date of receipt of HEARING’’ at the beginning of your
would benefit from this process because the reconsideration, and when a request comments.]
it provides access to judicial review is considered filed. In an effort to reduce the
more quickly in cases where the DAB We believe it is appropriate to include administrative burden and to assist the
does not have the authority to decide this information in proposed § 423.2002 ALJ in resolving the issue(s) in an
the question of law or regulation because it would be helpful to the appeal more appropriately, we
relevant to the matters in controversy enrollee and any representative of the introduced specific procedures in Part
and there is no material issue of fact in enrollee to understand how to file a 405, subpart I, to allow CMS and/or its
dispute, resulting in a more efficient request, how we would determine the contractors to participate in, or be a
appeals process. Therefore, we are date of receipt of the reconsideration, party to, an ALJ hearing. As explained
proposing in § 423.990 to provide Part D and when a request would be in the preamble to the Part 405, subpart
enrollees the opportunity to seek EAJR. considered filed. An enrollee must have I rule (70 FR 11459–11460), if CMS and/
We welcome comments on this a written IRE reconsideration notice or its contractors participate in an
proposal. before filing a request for an ALJ hearing appeal, ALJs may be able to resolve
because the administrative record issues of fact and law more quickly and
C. Appeals to an ALJ (§ 423.1000 cannot be forwarded to the ALJ level reduce the need for remands for
Through § 423.1063) until the written IRE reconsideration is additional factual development.
[If you choose to comment on issues completed, and the appeal cannot CMS participation would provide
in this section, please include the proceed at the ALJ level without the significant benefit to the appeals
caption ‘‘APPEALS TO AN ALJ’’ at the administrative record. We are also process, and would assist in creating a
beginning of your comments.] proposing in § 423.2002(b) that an more complete record. Section 1860D–
enrollee may request an expedited ALJ 4(h) of the Act and the Part D rule
1. General hearing, if the enrollee meets the neither require nor prohibit
The Part D rule contains two specific amount in controversy threshold and participation by CMS and/or its
provisions that apply to appeals before submits a request for an ALJ hearing contractors in an ALJ hearing. We
an ALJ. Current § 423.610 (proposed within 60 days after receipt of the recognize that an ALJ may determine
§ 423.1970) describes an enrollee’s right written notice of the IRE’s that it is appropriate to request
to an ALJ hearing and explains how the reconsideration where the appeal additional information from CMS, the
amount in controversy requirements involves an issue specified in IRE, and/or the Part D plan sponsor in
may be satisfied. Current § 423.612 § 423.566(b) but is not solely a request order to resolve an appeal. Thus, we are
(proposed § 423.1972) describes when for payment of Part D drugs already proposing in § 423.2010, to allow CMS,
and where to file a request for hearing, furnished, as discussed previously. the IRE, and/or the Part D plan sponsor
specifies that the time and place of the However, we are also proposing in to participate in an ALJ hearing at the
hearing will be set in accordance with § 423.2016(b) that the ALJ grant the ALJ’s discretion, in a manner similar to
the regulation governing Part A and Part request only if the enrollee’s prescribing § 405.1010 for Part A and Part B
B appeals at § 405.1020, and explains physician indicates or the ALJ appeals. Participation in an ALJ hearing
when the ALJ will dismiss a request for determines that applying the standard does not give the entities ‘‘party’’ status.
hearing because it does not meet the timeframe for making a decision may Proposed § 423.2010(c) would give the
amount in controversy requirement. seriously jeopardize the enrollee’s life or ALJ discretion about whether to allow
We are proposing to follow the health or ability to regain maximum CMS, the IRE, and/or the Part D plan
process set forth under Part A and Part function. sponsor to participate in situations
B for appeals to an ALJ, except as noted As discussed above, we believe that where any of these entities requests
above and below. We have tracked the an expedited process, similar to the participation. The ALJ would be
precluded from drawing any adverse 4. Request for an ALJ Hearing As discussed previously, we are
inference if CMS, the IRE, and/or the (§ 423.2014) proposing in § 423.2014(b), a more
Part D plan sponsor elected not to informal process for requesting an
[If you choose to comment on issues expedited hearing by proposing to
participate under proposed
in this section, please include the permit an enrollee to make a request for
§ 423.2010(g). caption ‘‘REQUEST FOR AN ALJ an expedited hearing orally. We believe
We believe that this proposal would HEARING’’ at the beginning of your that the oral request would make the
allow an ALJ to decide when an appeal comments.] initiation of the ALJ appeals process
would benefit from participation by one The Part D rule currently at faster and easier for the enrollee.
or more of these entities. An ALJ, § 423.612(a) and (b) (proposed However, as explained above in the
however, would have the flexibility to § 423.1972(a) and (b)) describes how, discussion of § 423.2002(b)(3), an
balance the interests of the enrollee with where, and when to file a request for an enrollee may only file an oral request for
the interests of these other entities and ALJ hearing. We are proposing to an expedited hearing after receiving the
to deny a request to participate. We include this requirement in § 423.2014. written IRE reconsideration notice. This
believe this proposal is consistent with We are also proposing to include in this requirement is reflected in
the preamble language to the Part D rule section language similar to that in § 423.2014(b). A prescribing physician
(70 FR 4360, 4361), with respect to the § 405.1014 on requests for an ALJ may also provide oral or written support
role of the Part D plan sponsor, which hearing, including the content of a for an enrollee’s request for expedited
states, ‘‘[t]he plan is not considered a request, where and when to file a hearing by an ALJ. In the same section,
party to the ALJ hearing, but may request and any extension of time to we also propose to require the ALJ
participate in the hearing at the request a hearing. We believe these hearing office to document and
discretion of the ALJ * * * [u]nlike provisions appropriately apply to Part D maintain documentation of this oral
under MA, the plans do not have the appeals. request.
Current § 423.612(b) (proposed Similarly, in § 423.2014(d)(2), we are
right to request an appeal of an ALJ
§ 423.1978(b)) states that ‘‘[e]xcept when proposing that an enrollee requesting an
decision with which the plan
an ALJ extends the timeframe as expedited hearing be permitted to
disagrees.’’ We noted in the Part D rule request orally an extension of time for
that ‘‘[e]ven though plans are not parties provided in part 422, subpart M of this
chapter, the enrollee must file a request filing the hearing request and that such
to ALJ hearings, we continue to believe request be documented in writing and
that it is important to give plans the for a hearing within 60 days of the date
of the notice of an IRE reconsideration maintained in the case file by the ALJ
ability to participate in ALJ hearings. hearing office.
Therefore, plans may participate in determination.’’ Similarly, § 422.602(b)
of the Part C rule states that ‘‘[e]xcept 5. Timeframes for Deciding an Appeal
hearings at the ALJ’s discretion.’’
when an ALJ extends the timeframe as Before an ALJ (§ 423.2016)
Further, if these entities do wish to provided in part 405 of this chapter, a
participate, we propose in § 423.2010(b) [If you choose to comment on issues
party must file a request for a hearing in this section, please include the
to require that the request to participate within 60 days of the date of the notice caption ‘‘TIMEFRAMES FOR DECIDING
be made within a shorter timeframe. For of a reconsidered determination.’’ AN APPEAL BEFORE AN ALJ’’ at the
expedited appeals, any request by CMS, Therefore, in proposed § 423.2014, we beginning of your comments.]
the IRE, and/or the Part D plan sponsor closely track the language of § 405.1014 As discussed above, we are proposing
to participate must be made within 1 regarding the time in which to request to apply a 90-day adjudicatory
day of receipt of the notice of hearing a hearing. Additionally, we are timeframe to Part D appeals with an
(5 days for non-expedited hearings). The proposing in § 423.2014(a)(1) and (a)(2) expedited process for certain types of
ALJ must then notify the entity, the to require the telephone number of the appeals. Specifically, we are proposing
enrollee, and the Part D sponsor, if enrollee and the designated in § 423.2016(b)(1), that an ALJ would
applicable, of his or her decision on the representative, if any, in any request for provide an expedited decision in
request to participate within 1 day of an ALJ hearing. This information would situations where the enrollee requests
receipt of the request (5 days for non- assist the ALJ in quickly contacting the an expedited hearing, the appeal
expedited appeals). We propose these enrollee or the designated involves an issue specified in
limitations due to the very tight representative, particularly for § 423.566(b), but does not include solely
timeframes for expedited appeals. expedited appeals. Because we are a request for payment of Part D drugs
proposing to adopt a specific provision already furnished and the enrollee’s
In Part D appeals all requests for an to govern requests for ALJ hearings in prescribing physician indicates, or the
ALJ hearing are brought by enrollees. Part D appeals, we propose to revise ALJ determines that applying the
Even if an enrollee is represented by a current § 423.612 (proposed § 423.1972) standard timeframe for making a
provider or supplier, that provider or to replace the reference to the decision may seriously jeopardize the
supplier will not have a direct financial regulations in part 422, subpart M, with enrollee’s life or health or ability to
interest in the appeal. Therefore, we are a cross reference to proposed regain maximum function. We also are
proposing that CMS, the IRE, and the § 423.2014. proposing that the ALJ may consider
Part D plan sponsor not be a party with Furthermore, we are proposing to this standard as met if a lower level
a right to request a hearing under Part require the plan name and the enrollee’s adjudicator has granted a request for an
D. As noted above, this proposed policy Medicare health insurance claim expedited appeal. The expedited
is consistent with the applicable number. This information would assist appeals process is similar to the process
statutory and regulatory provisions. the ALJ in identifying the relevant plan established at the Part D plan sponsor
Moreover, this proposal is consistent and formulary involved in the appeal. and IRE levels under the Part D rule at
with the preamble to the Part D rule (70 We also are proposing in § 423.570, § 423.584, and § 423.600.
FR at 4360) where we explicitly state § 423.2014(a)(7) that an enrollee who In § 423.2016(b), we are proposing
that the Part D plan sponsor is not a seeks an expedited hearing indicate that that the ALJ rule on a request for
party to the appeal. in his or her request. expedited hearing within 5 days of
receiving the request. We also are 7. Time and Place for a Hearing Before expedited hearing notices be mailed or
proposing in this section that the ALJ an ALJ (§ 423.2020) served at least 3 days before the hearing.
give the enrollee prompt oral notice of [If you choose to comment on issues 9. Objections to the Issues and
this decision. If the ALJ denies a request in this section, please include the Disqualification of the ALJ (§ 423.2024
for an expedited hearing, the ALJ will caption ‘‘TIME AND PLACE FOR A and § 423.2026)
explain that the appeal would be HEARING BEFORE AN ALJ’’ at the
processed using the 90-day timeframe, [If you choose to comment on issues
beginning of your comments.] in this section, please include the
and send an equivalent written notice The Part D rule currently at
within 3 days of issuance of the oral caption ‘‘OBJECTIONS TO THE ISSUES
§ 423.612(b) (proposed § 423.1972(a)) AND DISQUALIFICATION OF THE
notice to the enrollee and to the Part D describes the time and place for a
plan sponsor. We propose in ALJ’’ at the beginning of your
hearing before an ALJ and requires that comments.]
§ 423.2016(b)(4), that a decision on a it be set in accordance with § 405.1020.
request for an expedited hearing cannot We are proposing to follow in
Therefore, we are proposing to include § 423.2024 and § 423.2026 the language
be appealed to the MAC. If the ALJ in § 423.2020 language similar to that
accepts the request for expedited in § 405.1024 and § 405.1026, which
set forth in § 405.1020, including discusses the process for objecting to
hearing, we propose in § 423.2016(b)(5), information on the determination of
that the ALJ issue a written decision, issues in the notice of hearing and
how appearances are made, the notice of disqualification of the ALJ. We believe
dismissal order, or remand as a hearing, an enrollee’s right to waive a
expeditiously as the enrollee’s health it is appropriate to allow enrollees to
hearing, an enrollee’s objection to the object to the issues described in the
condition requires, but no later than the time and place of hearing, good cause
end of the 10-day period beginning on notice of hearing and to maintain the
for changing the time and place of the processes set forth for Part A and Part
the date the request for hearing is hearing, the effect of rescheduling a
received. B appeals for disqualification of the ALJ
hearing, and an enrollee’s request for an for Part D appeals.
Although the timeframe for the in-person hearing. Additionally, for expedited hearings,
issuance of a written decision is As discussed previously, we propose we are proposing in § 423.2024(a) and
somewhat longer than at the lower a more informal process for expedited § 423.2026(b), that an enrollee may
levels, we believe this is appropriate. hearings by proposing in submit oral or written notice of
The ALJ hearing is more complicated § 423.2020(e)(3) and (i)(3) to allow objections to issues described in the
than an IRE reconsideration because it objections to the time and place for a notice of hearing no later than 2 days
involves the scheduling and conducting hearing and requests for in-person before the hearing and orally notify the
of a hearing. The hearing entails the hearings to be made orally, and to ALJ no later than 2 days after the date
presentation of evidence including require the ALJ hearing office to of the notice of hearing about any
testimony by parties and witnesses, document all oral objections or requests objections to the ALJ who will conduct
necessitates a longer adjudication and maintain such documentation in the hearing. Further, in the same
period. the case files. We are also proposing in proposed sections, we are proposing
6. Submitting Evidence Before the ALJ § 423.2020(i)(4) to not waive the that the ALJ document all objections or
Hearing (§ 423.2018) adjudication period for expedited requests in writing and maintain the
hearings when an enrollee’s request for documentation in the case files.
[If you choose to comment on issues an in-person hearing is granted because
in this section, please include the a waiver of the adjudication period 10. When an ALJ May Remand a Case
caption ‘‘SUBMITTING EVIDENCE under the circumstances of an expedited (§ 423.2034)
BEFORE THE ALJ HEARING’’ at the appeal could be detrimental to the [If you choose to comment on issues
beginning of your comments.] enrollee’s health condition. in this section, please include the
We are proposing in § 423.2018 to caption ‘‘WHEN AN ALJ MAY
adopt concepts from § 405.1018 8. Notice of a Hearing Before an ALJ REMAND A CASE’’ at the beginning of
regarding when an enrollee must submit (§ 423.2022) your comments.]
written evidence. However, we also [If you choose to comment on issues We are proposing to include language
propose in this section to permit an in this section, please include the in § 423.2034 similar to that in
enrollee to submit any written evidence caption ‘‘NOTICE OF A HEARING § 405.1034 regarding when an ALJ may
about his or her condition at the time of BEFORE AN ALJ’’ at the beginning of remand a case. This language is
the coverage determination but require your comments.] appropriate for Part D appeals because,
the ALJ to remand a case to the Part D We are proposing to mirror the like Part A and Part B appeals, it may
plan sponsor where an enrollee wishes language in § 405.1022 regarding notice be necessary for an ALJ to remand a case
to have evidence considered on changes of hearing before an ALJ in § 423.2022. to a lower level. However, for the
in his or her condition since the We believe that it is appropriate to reasons stated above, we are proposing
coverage determination. apply to Part D appeals procedures at § 423.2034(c), to require the ALJ to
Additionally, we are proposing in similar to the Part A and Part B remand a case to the Part D plan
§ 423.2018(b) and (c) that an enrollee procedures regarding notice of a sponsor if the ALJ determines that the
must submit all written evidence that he hearing. Additionally, as discussed enrollee wishes to have evidence on his
or she wishes to have considered at the previously, we propose a more informal or her change in condition after the
hearing within 2 days of receiving the process with respect to expedited coverage determination considered in
notice of hearing for expedited appeals hearings by proposing in § 423.2022(a) the appeal. As stated previously, if the
and 10 days for non-expedited appeals. to allow ALJs to transmit the notice of enrollee submits this type of evidence
We believe that requiring evidence to be the hearing to the enrollee and other but wishes not to have it considered, the
submitted within these timeframes potential participants orally followed by ALJ would be able to proceed with the
provides the adjudicator sufficient time an equivalent written notice within one appeal without considering the
to review all evidence submitted before day of the oral notice. Additionally, we evidence on the enrollee’s change in
the hearing. are proposing in the same provision that condition.
11. Description of an ALJ Hearing appeals, because an ALJ may need to enrollee’s health condition requires, but
Process (§ 423.2036) obtain additional information in order no later than the end of the 10-day
[If you choose to comment on issues to resolve an issue(s) in a Part D appeal. period for expedited hearings.
in this section, please include the In instances when an ALJ issues a
subpoena, we intend to follow similar 14. Dismissal of a Request for Hearing
caption ‘‘DESCRIPTION OF AN ALJ Before an ALJ (§ 423.2052)
HEARING PROCESS’’ at the beginning procedures regarding the reviewability
of your comments.] and enforcement of subpoenas as [If you choose to comment on issues
We reviewed the language in outlined in 405.1036(f). in this section, please include the
§ 405.1036 to determine whether to 12. Deciding a Case Without a Hearing caption ‘‘DISMISSAL OF A REQUEST
incorporate similar language in Before an ALJ and Prehearing and FOR HEARING BEFORE AN ALJ’’ at the
proposed § 423.2036. In general, we Posthearing Conferences (§ 423.2038 beginning of your comments.]
follow the procedures set forth for Part and § 423.2040) We are proposing in § 423.2052, to
A and Part B appeals regarding the right follow the language in § 405.1052
[If you choose to comment on issues regarding dismissal of a request for an
to appear and present evidence, waiver in this section, please include the
of the right to appear, presenting written ALJ hearing because we believe that it
caption ‘‘DECIDING A CASE WITHOUT is appropriate for an ALJ to dismiss Part
statements and oral arguments, waiver A HEARING BEFORE AN ALJ AND
of the adjudication period, what D appeals for the same reasons as an
PREHEARING AND POSTHEARING ALJ would dismiss Part A and Part B
evidence is admissible at a hearing, and CONFERENCES’’ at the beginning of
witnesses at a hearing. With respect to appeals. We also are proposing to
your comments.] shorten the timeframes for expedited
waiver of the right to appear for We are proposing in § 423.2038 and
expedited hearings, we propose at appeals in two instances.
§ 423.2040 to follow the language set First, we propose at
§ 423.2036(b), to allow an enrollee to forth in § 405.1038 and § 405.1040,
indicate orally that he or she does not § 423.2052(a)(2)(ii), that an ALJ may
which discusses the process for dismiss a request for expedited hearing
wish to appear at a hearing (with deciding a case without a hearing before
appropriate documentation of this when the enrollee (or his or her
an ALJ and prehearing and posthearing representative) does not appear at the
request and maintenance of this conferences. We believe it is appropriate
documentation by the ALJ hearing time and place set for the hearing and
to use these processes for Part D has not contacted the ALJ hearing office
office). At § 423.2036(b)(2), we propose appeals. Additionally, for expedited
to allow an enrollee to withdraw his or within 2 days (instead of the standard
hearings, we are proposing in 10 days for non-expedited appeals) and
her waiver in writing. We also propose § 423.2038(b)(1)(i) and § 423.2040(c),
that by withdrawing his or her waiver, provided good cause (as determined by
that an enrollee may orally notify the the ALJ) for not appearing.
the enrollee agrees to an extension of ALJ that he or she does not wish to
the adjudication period as specified in Second, we propose at
appear before the ALJ at a hearing and
§ 423.2016 that may be necessary to § 423.2052(a)(2)(iii), that an ALJ may
may also orally indicate that he or she
schedule and hold a hearing. For the dismiss a request for hearing when the
does not wish to receive a written notice
reasons discussed above, we are enrollee (or his or her representative)
of the conference.
proposing in § 423.2036(e) (what Further, we are proposing that the ALJ does not appear at the time and place
evidence is admissible at a hearing) that document all objections or requests in set for the hearing and if the ALJ sends
an ALJ may not consider evidence on writing and maintain the documentation a notice to the enrollee asking why the
any change in condition of the enrollee in the case files. enrollee did not appear, the ALJ does
after the coverage determination by the Finally, we are proposing in not receive a response to the notice from
plan sponsor. § 423.2040(c) that, for expedited the enrollee within 2 days for expedited
We are proposing not to include hearings, the ALJ inform the enrollee of hearings (and 10 days for non-expedited
language similar to that in § 405.1036(f) the time, place, and purpose of the hearings) or the enrollee does not
on requests for subpoenas by a party. In conference within a shorter timeframe provide good cause for failing to appear.
Part 405, subpart I, requests for (at least 2 days before the conference We also are proposing at
subpoena by a party are limited to date) than for non-expedited appeals (at § 423.2052(a)(5), that a request for
instances where discovery has been least 7 days before the conference date). hearing may be dismissed if the enrollee
sought. Discovery is permissible under dies while the request for hearing is
Part 405, subpart I only when CMS and/ 13. Notice of an ALJ Decision pending and the enrollee’s
or its contractors participate in an ALJ (§ 423.2046) representative has no remaining
hearing as a party, because it is [If you choose to comment on issues financial interest in the case and does
appropriate to permit discovery when in this section, please include the not continue the appeal. Unlike
an ALJ hearing is adversarial (that is, caption ‘‘NOTICE OF AN ALJ Medicaid State agencies in Part A and
whenever CMS and/or its contractor is DECISION’’ at the beginning of your Part B appeals, State Pharmaceutical
a party). comments.] Assistance Programs (SPAPs) do not
For Part D appeals, however, we We are proposing in § 423.2046 to have an independent right to appeal.
propose that only an enrollee may be a follow the procedures in § 405.1046 While a SPAP may have a financial
party, and therefore, Part D appeals will regarding notice of an ALJ decision. We interest and may wish to pursue an
not be adversarial in nature. Thus, we believe it is appropriate to provide a appeal, the SPAP would have authority
are proposing not to apply to Part D similar notice process in Part D appeals. to do so only if the SPAP was appointed
appeals the provisions in § 405.1036(f), We are not proposing to include as the enrollee’s representative.
which discuss subpoenas at the request language from § 405.1046(a) regarding Therefore, we are proposing that if an
of a party, and § 405.1037, which overpayment cases involving multiple SPAP has been appointed as the
discuss discovery. However, we propose beneficiaries because Part D appeals do enrollee’s representative, the SPAP
to allow an ALJ to issue a subpoena on not involve overpayments. We also are could continue an appeal after an
his or her own initiative, as under proposing in § 423.2046(d), that an ALJ enrollee dies provided that the
§ 405.1036(f) for Part A and Part B issue a decision, as expeditiously as the appointment continues to be valid.
Additionally, we are proposing at the 10 day adjudicatory timeframe for to provide an expedited decision where
§ 423.2052(b) to follow the language of expedited reviews. an enrollee requests the review, the
§ 405.1052(b), which requires the ALJ to appeal involves an issue specified in
3. Request for MAC Review When ALJ
mail a written notice of dismissal to the § 423.566(b), but does not include solely
Issues Decision or Dismissal
enrollee. a request for payment of Part D drugs
(§ 423.2102)
already furnished, and the enrollee’s
D. Appeals to the MAC (§ 423.2100 We are proposing to include in prescribing physician indicates, or the
Through § 423.2134) § 423.2102 language similar to that set MAC determines that applying the
[If you choose to comment on issues forth in § 405.1102 on requests for MAC standard timeframe for making a
in this section, please include the review when the ALJ issues a decision decision may seriously jeopardize the
caption ‘‘APPEALS TO THE MAC’’ at or dismissal. We believe it is enrollee’s life or health or ability to
the beginning of your comments.] appropriate to include this information regain maximum function. We also are
in proposed § 423.2102 because it proposing that the MAC may consider
1. General would help the enrollee and any this standard as met if a lower level of
representative of the enrollee to adjudicator has granted a request for an
The Part D rule includes one
understand how to file a request for expedited appeal.
provision concerning MAC review.
MAC review and how the date of receipt We are proposing in
Current § 423.620 (proposed § 423.1974)
of the request would be determined, and § 423.2108(d)(2)(i) that the MAC deny a
provides that an enrollee who is
when a request would be considered request for expedited review, because
dissatisfied with an ALJ’s hearing
filed. We also are proposing at the standard for expedited review is not
decision may request that the MAC
§ 423.2102(a)(2), that an enrollee may met, within 5 days after receiving the
review the ALJ decision or dismissal.
request expedited review if the enrollee request for expedited review. We also
Further, it states that ‘‘[t]he regulations
submits a written request for MAC are proposing in § 423.2108(d)(2)(ii) that
under part 422, subpart M of this
review within 60 days after receipt of the MAC would send the enrollee and
chapter regarding MAC review apply to the ALJ’s decision or dismissal and the Part D plan sponsor written notice of the
matters addressed by this subpart, to the appeal involves an issue specified in denial within 5 days after receiving the
extent applicable.’’ Section 422.608 of § 423.566(b) but does not include solely request that explains that the appeal
the Part C rule states that ‘‘[t]he a request for payment of Part D drugs will be processed using the 90-day
regulations under part 405 of this already furnished. timeframe. Instead of notifying the
chapter regarding MAC review apply to As discussed above, we believe that enrollee and Part D plan sponsor that
matters addressed by this subpart to the an expedited MAC review process the MAC has granted the request for
extent that they are appropriate.’’ similar to the expedited process expedited review, we propose to use
Therefore, we propose in the provisions provided at lower levels of appeal these resources to process the expedited
regarding MAC review to follow the would benefit enrollees who need quick appeal.
language in Part 405, subpart I, as decisions about Part D drugs due to If the MAC accepts the request for
appropriate and have tracked the their health status. We are proposing at expedited review, we propose in
language in the Part 405, subpart I, for § 423.2102(a)(2), a more informal § 423.2108(d)(2), that the MAC issue a
proposed § 423.2106, § 423.2116, process for requesting an expedited decision, dismissal order, or remand, as
§ 423.2118, § 423.2120, § 423.2128, and review by proposing to permit an expeditiously as the enrollee’s health
§ 423.2130. In addition, because we are enrollee to make a request for review condition requires, but no later than the
proposing to adopt a specific provision orally. We believe that the oral request end of the 10-day period beginning on
to govern requests for MAC review in would make the initiation of the MAC the date the request for review is
Part D appeals, we propose to revise appeals process faster and easier for the received by the entity specified in the
current § 423.620 (proposed § 423.1974) enrollee. A prescribing physician may ALJ’s written notice of decision. This
to replace the reference to the also provide oral or written support for process is similar to the process
regulations in part 405, subpart I, with an enrollee’s request for expedited established at the coverage
a cross reference to proposed review by the MAC. We also are determination, redetermination, and
§ 423.2102. proposing in § 423.2102(a)(2)(ii) to reconsideration levels under the Part D
2. Medicare Appeals Council Review: require the MAC to document and rule at § 423.570, § 423.584, and
General (§ 423.2100) maintain documentation of this oral § 423.600.
request.
The Part D rule currently at § 423.620 Similarly, in § 423.2102(b)(1), we are 5. MAC Review on Its Own Motion
(proposed § 423.1970) provides that an proposing that an enrollee requesting an (§ 423.2110)
enrollee who is dissatisfied with an expedited review be permitted to orally On March 23, 2007, CMS published a
ALJ’s hearing decision may request that request an extension of time for filing CMS Ruling (CMS–4083–NR) in the
the MAC review the ALJ decision or the request, and that the request be Federal Register. The CMS ruling
dismissal. We are proposing to include documented in writing and maintained established an interim process for
this requirement in § 423.2100. We are in the case file by the MAC. referring Part D cases to the MAC for
also proposing in § 423.2100 to follow review under its own motion authority.
the language of § 405.1100, which 4. MAC Actions When Request for This ruling permits CMS and its IRE to
describes who may request MAC Review Is Filed (§ 423.2108) refer cases to the MAC for own motion
review, the de novo standard of MAC We are proposing to follow the review and largely applies the
review, and timeframes for issuing a requirements in § 405.1108 regarding provisions of § 405.1110, with the
decision or remand because we believe MAC actions when a request for review notable exception of the standard of
that Part D appeals should not differ is filed, including de novo review of an review.
from Part A and Part B appeals with ALJ’s decision. Specifically, we propose We propose in this rule to largely
respect to these provisions, except as in § 423.2108(d) an expedited process follow this Ruling and the requirements
discussed above. We further propose for certain types of appeals. We propose set forth in § 405.1110 regarding MAC
language in § 423.2100(c) establishing in § 423.2108(d)(1), to require the MAC own motion reviews, with certain
modifications. Proposed § 423.2110, review. This information would assist such a case to the Part D plan sponsor.
reflects our proposal that the enrollee is the MAC in contacting the enrollee, Like in § 405.1122, we are proposing in
the only party to an ALJ hearing and particularly for expedited appeals. § 423.2122 to allow the MAC to issue a
that CMS and/or the Part D IRE may Additionally, we are proposing in subpoena when it determines certain
participate as a non-party in the ALJ § 423.2112(a)(4) to require the plan information is reasonably necessary for
hearing. Proposed § 423.2110 differs name and the enrollee’s Medicare health a full presentation of a case. We also are
from § 405.1110 in that § 423.2110 insurance claim number. We also are proposing in § 423.2122(b) not to
applies the same standard of review to proposing at § 423.2112(a)(4), that an include language similar to that in
such requests whether CMS or IRE enrollee who seeks an expedited review § 405.1122(d) on party requests for
simply requested to participate in the indicate that his or her request is for an subpoenas, as only the enrollee is a
ALJ hearing or actually participated in expedited review. party to a Part D appeal, and as a result,
the ALJ hearing. This proposed As discussed previously, we propose there will be no discovery in these
difference is due to the ALJ having the in § 423.2112(a)(2) a more informal appeals. For the reasons set forth above,
discretion under proposed § 423.2010 process for requesting an expedited we are proposing to allow the MAC to
not to allow CMS or the Part D IRE to review by proposing to permit an issue a subpoena only on its own
participate as a non-part in the ALJ enrollee to make a request for review initiative. In addition, if necessary, the
hearing. Because ALJs have discretion to orally. We believe that the oral request MAC may request enforcement of a
deny a CMS or IRE request to participate would make the initiation of the MAC subpoena by the Secretary. The time
in an ALJ hearing, we believe it is appeals process faster and easier for the period for the MAC to issue a final
appropriate under § 423.2110 to apply enrollee. We also are proposing to action or remand the case would be
the same standard of review to requests require the MAC to document and stayed for 15 days or until the Secretary
for MAC own motion review whether maintain documentation of this oral makes a decision with respect to the
CMS or IRE requested to participate or request. enforcement request, whichever occurs
actually participated in the ALJ hearing. 7. Dismissal of Request for Review first.
For administrative efficiency, we are
(§ 423.2114) 9. Oral Argument (§ 423.2124)
proposing to limit to CMS and the Part
D IRE the ability to refer a case to the In § 423.2114, we are proposing the We are proposing in § 423.2124, to
MAC for review under its own motion process for dismissing a request for follow the language similar to that in
authority. We expect that most of the review for Part D appeals. The proposed § 405.1124 because we believe that oral
referrals would be made through the process tracks the Part A and Part B arguments may be necessary in some
Part D IRE, because it is responsible for process, except for dismissals involving Part D appeals. We also are proposing in
monitoring plan effectuation of deceased enrollees. We are proposing at § 423.2124(b) that, for expedited
favorable decisions and serves as a § 423.2114(c), that a request for review appeals, the enrollee be informed of the
repository for all completed Part D ALJ may be dismissed if the enrollee dies time and place of the oral argument at
case files. while the request for review is pending least 2 days before the scheduled date
The Part D IRE does not have a and the enrollee’s representative, if any, of the oral argument, which is shorter
financial or business interest in the either has no remaining financial than our proposed 10-day timeframe for
outcome of the case. Therefore, we interest in the case or does not continue non-expedited appeals. We believe that
believe that the Part D IRE is in the best the appeal. As discussed above, unlike providing notice of an oral argument
position to objectively examine whether Medicaid State agencies in Part A and within these timeframes provides the
an ALJ decision warrants review by the Part B appeals, SPAPs do not have an enrollee sufficient time to prepare for
MAC. While Part D plan sponsors independent right to appeal. While an the oral argument.
would not be permitted to refer a Part SPAP may have a financial interest and
10. Case Remanded by the MAC
D case to the MAC for review under its may wish to pursue an appeal, the SPAP
(§ 423.2126)
own motion authority, Part D plan would have authority to do so only if
sponsors would have the opportunity to the SPAP was appointed as the We are proposing in § 423.2126, to
communicate with, and provide input enrollee’s representative. Therefore, we mirror the language in § 405.1126
to, CMS or the Part D IRE on ALJ propose that an SPAP that has been regarding when the MAC may remand a
decisions that may warrant a referral to appointed as the enrollee’s case. This language is appropriate for
the MAC. Given the large number of representative could continue an appeal Part D appeals because it may be
Part D plans, we believe that limiting after an enrollee dies provided that the necessary for the MAC to remand a case
own motion referrals to CMS and the appointment continues to be valid. to a lower level. Additionally, we are
Part D IRE is a more streamlined and proposing in § 423.2126(a)(4), that when
8. What Evidence May Be Submitted to an ALJ has issued a recommended
efficient approach. We welcome the MAC (§ 423.2122)
comments on this proposed approach. decision, an enrollee may file with the
We also note that CMS Ruling (CM– We reviewed the language in MAC briefs or other written statements
4083–NR) would be superseded by these § 405.1122 to determine whether to about the facts and law relevant to the
regulations upon implementation of a incorporate similar language in case within 20 days of the date on the
final rule. proposed § 423.2122. In general, we are recommended decision or with the
proposing to follow the procedures for request for review for expedited
6. Content of Request for Review Part A and Part B appeals regarding appeals. As discussed above, we also are
(§ 423.2112) what evidence may be submitted to the proposing in § 423.2126(b), to require
We are proposing to include in MAC. For the reasons discussed above, the MAC to remand a case to the Part
§ 423.2112 language similar to that in we are proposing in § 423.2122(a)(3) D plan sponsor if the MAC determines
§ 405.1112 on content of a request for that the MAC would not consider that the enrollee wishes to have
review. However, we propose at evidence on any change in condition evidence on his or her change in
§ 423.2112(a)(4), to require the after a coverage determination by the condition after the coverage
telephone number of the enrollee to be plan sponsor that the enrollee wishes to determination by the plan sponsor
included in any request for MAC have considered and would remand considered in the appeal.
E. Judicial Review (§ 423.2136 Through VI. Response to Comments any 1 year. Individuals and States are
§ 423.2140) Because of the large number of public not included in the definition of a small
comments we normally receive on entity.
[If you choose to comment on issues This proposed rule will affect
in this section, please include the Federal Register documents, we are not
primarily individuals enrolled in Part D
caption ‘‘JUDICIAL REVIEW’’ at the able to acknowledge or respond to them
plans who appeal Part D plan decisions.
beginning of your comments.] individually. We will consider all
It makes no substantive changes in the
comments we receive by the date and
The Part D rule includes one Part D benefit and deals directly only
time specified in the DATES section of
provision concerning judicial review. with appeals procedures administered
this preamble, and, when we proceed by Federal employees. To date, the
Current § 423.630(a) (proposed
with a subsequent document, we will volume of Part D appeals is small and
§ 423.1976(a)) provides that an enrollee
respond to the comments in the the amounts of money involved,
may request judicial review of an ALJ’s
preamble to that document. although substantial to many of these
decision if the MAC denied the
enrollee’s request for review and the VII. Regulatory Impact Statement individuals, are a very small percentage
amount in controversy threshold is met. of aggregate Part D plan costs.
[If you choose to comment on issues
Current § 423.630(b) (proposed Accordingly, we do not believe that
in this section, please include the
§ 423.1976(b)) also states that an there will be significant economic
caption ‘‘Regulatory Impact Analysis’’ at
enrollee may request judicial review of impacts on Part D plans. Therefore, the
the beginning of your comments.] Secretary has determined that this
the MAC decision if it is the final
agency decision and the amount in A. Overall Impact proposed rule would not have a
controversy threshold is met. To request significant economic impact on a
We have examined the impacts of this
judicial review, this section states that substantial number of small entities.
rule as required by Executive Order In addition, section 1102(b) of the Act
an enrollee must file a civil action in a 12866 (September 1993, Regulatory
District Court of the United States in requires us to prepare an RIA if a rule
Planning and Review), the Regulatory may have a significant impact on the
accordance with section 205(g) of the Flexibility Act (RFA) (September 19,
Act. Finally, current § 423.630(c) operations of a substantial number of
1980, Pub. L. 96–354), section 1102(b) of small rural hospitals. This analysis must
(proposed § 423.1976(c)) tells the reader the Social Security Act, the Unfunded
to ‘‘[s]ee part 422, subpart M of this conform to the provisions of section 603
Mandates Reform Act of 1995 (Pub. L. of the RFA. For purposes of section
chapter, for a description of the 104–4), Executive Order 13132 on
procedures to follow in requesting 1102(b) of the Act, we define a small
Federalism, and the Congressional rural hospital as a hospital that is
judicial review.’’ Review Act (5 U.S.C. 804(2)). located outside of a metropolitan
Section 422.612 explains that part 405 Executive Order 12866 (as amended) statistical area and has fewer than 100
contains a description of the procedures directs agencies to assess all costs and beds. This rule will not have any effect
to follow in requesting judicial review. benefits of available regulatory on hospitals. Therefore, the Secretary
Therefore, we propose to follow the alternatives and, if regulation is has determined that this proposed rule
language of the Part 405, subpart I, as necessary, to select regulatory will not have a significant impact on the
appropriate. Thus, we have tracked the approaches that maximize net benefits operations of a substantial number of
language in the Part 405, subpart I, for (including potential economic, small rural hospitals.
proposed § 423.2134, § 423.2138, and environmental, public health and safety Section 202 of the Unfunded
§ 423.2140. We believe that it is effects, distributive impacts, and Mandates Reform Act of 1995 (UMRA)
appropriate for Part D appeals to follow equity). A regulatory impact analysis also requires that agencies assess
the Part A and Part B appeals (RIA) must be prepared for major rules anticipated costs and benefits before
procedures set forth in these provisions. with economically significant effects issuing any rule whose mandates
Because we propose to adopt specific ($100 million or more in any 1 year). As require spending in any 1 year of $100
procedures for requesting judicial explained in the analysis that follows, million in 1995 dollars, updated
review of final Part D decisions, we we have determined that this proposed annually for inflation. That threshold
propose to delete the cross-reference to rule is not a major rule since it will level is currently approximately $130
Part 422, subpart M, from current impose no consequential costs and will million. This proposed rule contains no
§ 423.620(c) (proposed § 423.1976(c)) not have an economic effect of $100 mandates on State, local, or tribal
and replace it with a cross-reference to million or more. Accordingly, it is not governments in the aggregate, or on the
the proposed procedures for requesting a major rule. private sector.
judicial review in proposed § 423.2136. The RFA requires agencies to analyze Executive Order 13132 establishes
V. Collection of Information options for regulatory relief of small certain requirements that an agency
Requirements businesses, if a rule has a significant must meet when it promulgates a
impact on a substantial number of small proposed rule (and subsequent final
This document does contain entities. For purposes of the RFA, we rule) that imposes substantial direct
information collection requirements; estimate that a number of Part D plan requirement costs on State and local
however, the Paperwork Reduction Act sponsors (insurers) are small entities as governments, preempts State law, or
of 1995 exempts the information that term is used in the RFA (include otherwise has Federalism implications.
collection activities referenced in this small businesses, nonprofit This proposed rule has no such effects.
Proposed Rule. In particular, 5 CFR organizations, and small governmental
1320.4 excludes collection activities jurisdictions). As indicated above, a B. Anticipated Effects
during the conduct of administrative number of Part D plan sponsors This proposed rule has no direct
actions such as redeterminations, (insurers) are small entities due to their effects on the original Medicare
reconsiderations, and/or appeals. nonprofit status. Few if any of the Part program, since it applies only to the Part
Specifically, these actions are taken D plans sponsors meet the SBA size D prescription drug program. It would
after the initial determination or a standard for a small insurance firm by have few direct effects on Part D plans,
denial of payment. having revenues of $6 million or less in since it addresses primarily the details
of appeals procedures and process at the As discussed earlier in this preamble, contrast, total Part D spending in
ALJ hearing and MAC review levels. our existing policy is that, unless calendar 2007 (which is roughly
Most of the proposed procedures do not otherwise provided, Part D procedures equivalent to the fiscal year total) is
vary substantially from existing appeals will follow the procedures established estimated to be approximately $50
practices. For example, both under for appeals under Part A and Part B to billion dollars. Thus, viewed either in
existing practices, upon which this the extent they are appropriate. The absolute or relative terms, any effects of
proposed rule is largely modeled, and proposed provisions parallel the Part A the proposed rule either on the
the proposed rule, neither the and Part B provisions, to the extent administrative costs or outcomes of
government nor the Part D sponsor is a appropriate. For example, in this these cases are unlikely to be more than
‘‘party’’ to the appeal and therefore proposed rule we have proposed to a fraction of one percent of the major
neither incurs any legal costs, unless it eliminate references to national and rule threshold. Likewise, effects on
chooses to participate in the ALJ hearing local coverage determinations because overall plan costs or benefit payments
or MAC review. However, some these policies do not apply to Part D. are likely to be minimal.
provisions would be new. Most Likewise; we eliminate references to
importantly, we propose to provide for Social Security appeals because they are Accordingly, we do not believe that
an expedited appeals process when a irrelevant to Part D. We note that such these procedures, which include both
delay in obtaining a drug may seriously changes do not necessarily imply an codifications of existing practices and
jeopardize the enrollee’s life, health, or actual change in the procedures for new procedures for the third and fourth
ability to regain maximum function. processing Part D appeals. The proposed levels of appeal will have any
This change would affect spending by rule would in part simply codify consequential net effect on the Part D
Part D and the Medicare program by existing practices already in place. program, except to clarify the
accelerating coverage of a drug in those Other changes we propose are intended procedures that will apply to the
cases where the enrollee succeeded in to make the appeals process more relatively small number of cases that
the expedited appeal. flexible and responsive to the needs and reach those levels of the appeals
The Part D appeals process is circumstances of program participants. process. While the volume of appeal
administered in large part by the plans For example, a common type of appeal cases may increase slightly, adopting
themselves. Our rules require plans to is an appeal from the denial of coverage the procedures outlined in this
have effective grievance and appeals for a drug used for an ‘‘off-label’’ proposed rule would benefit enrollees
processes that operate timely and indication (one that has not been by clarifying the procedures that will
effectively to meet enrollee needs. In officially approved by the Food and apply to these appeals and affording an
addition, we impose substantive Drug Administration). Medicare Part D opportunity to request an expedited
standards on issues such as plan pays for many, but not all, ‘‘off-label’’
formularies and the process for appeal in certain circumstances where a
uses. The process and procedure faster decision is necessary in order to
obtaining exceptions from formulary changes we propose do not directly
restrictions where medically necessary. protect the life and health of the
change the likelihood an enrollee will enrollee. We welcome comments on
We provide for within-plan appeals prevail in appeal, although they may
from initial plan decisions. If a problem these conclusions.
slightly raise the number of such
cannot be resolved at the plan level, we appeals by clarifying the procedures C. Alternatives Considered
provide for an independent external that will apply to such appeals and
review through a CMS contractor. (Cases There are no major alternatives to this
affording an opportunity to request an
concerning the quality of care take a proposed rule. We have proposed a
expedited appeal. The new expedited
different route, through Quality number of specific provisions and
appeals procedures will allow us to
Improvement Organizations.) Only provided a justification for each,
respond quickly to urgent medical
those cases where the problem cannot throughout this preamble. We welcome
needs of enrollees.
be resolved at those levels go to the so- comments on these proposals and on
called third and fourth levels of appeal Total enrollment in Part D plans is
about 25 million persons (including any effects that we may not have
for a hearing before an ALJ and review anticipated, as well as comments on
by the Medicare Appeals Council, enrollment in Medicare Advantage
Plans that cover prescription drugs). We additional or alternative reforms that
respectively. could improve the appeals process
The primary effects of this proposed estimate the total number of third level
appeals (ALJ hearings) in fiscal year further.
rule will be to tailor the third and fourth
level appeal procedures, designed 2007 to be approximately 350, or about In accordance with the provisions of
primarily for the original Medicare 15 appeals per million enrollees. Only Executive Order 12866, this proposed
program, to the unique aspects of the a fraction of these would ever be rule was reviewed by the Office of
Part D program. This proposed rule appealed to the fourth level (MAC Management and Budget.
reflects and builds upon recent changes review). While the dollar value of these
in the third and fourth levels of appeals appeals has not been tabulated, the List of Subjects in 42 CFR Part 423
process for Part A and Part B claims amount is likely to reach several Administrative practice and
appeals (see the Interim Final Rule at 70 thousand dollars on average (the procedure, Emergency medical services,
FR 11420 (March 8, 2005)). We note that amount in controversy threshold for an
Health facilities, Health maintenance
the effects of that rule were extensively appeal in 2008 is $120 for ALJ hearings
organizations (HMO), Health
analyzed in the Regulatory Impact and $1180 for federal district court
professionals, Medicare, Penalties,
Analysis published with the rule. The review, but the time and effort involved
to pursue an appeal is likely to foster Privacy, Reporting and recordkeeping

overall conclusion of that impact
analysis was that costs to affected appeals most frequently when the requirements.
persons and entities would be minimal, amount is considerably higher). For the reasons set forth in the
although the anticipated costs to the Consequently, the annual total of the preamble, the Centers for Medicare &
Federal government from revised amounts in controversy is likely to be in Medicaid Services proposes to amend
procedures would be substantial. the range of several million dollars. In 42 CFR chapter IV as set forth below:
PART 423—VOLUNTARY MEDICARE and the cross-reference to ‘‘§ 423.1970’’ 423.2036 Description of an ALJ hearing
PRESCRIPTION DRUG BENEFIT is added in its place. process.
423.2038 Deciding a case without a hearing
1. The authority citation for part 423 § 423.604 [Amended] before an ALJ.
continues to read as follows: 8. In § 423.604, the cross-reference to 423.2040 Pre-hearing and post-hearing
‘‘§ 423.612’’ is removed, and the cross- conferences.
Authority: Secs 1102, 1860D–1 through 423.2042 The administrative record.
1860D–42, and 1871 of the Social Security reference to ‘‘§ 423.1972’’ is added in its 423.2044 Consolidated hearing before an
Act (42 U.S.C. 1302, 1395w–101 through place. ALJ.
1395w–152, and 1395hh). 423.2046 Notice of an ALJ decision.
§ 423.610 [Removed and Reserved]
2. The heading for Subpart M is 423.2048 The effect of an ALJ’s decision.
revised to read as follows: 9. Section 423.610 is removed and 423.2050 Removal of a hearing request from
reserved. an ALJ to the MAC.
Subpart M—Grievances, Coverage 423.2052 Dismissal of a request for a
§ 423.612 [Removed and Reserved] hearing before an ALJ.
Determinations, Redeterminations, and
Reconsiderations 10. Section 423.612 is removed and 423.2054 Effect of dismissal of a request for
reserved. a hearing before an ALJ.
3. A new § 423.558, is added to 423.2062 Applicability of policies not
Subpart M to read as follows: § 423.620 [Removed and Reserved] binding on the ALJ and MAC.
11. Section 423.620 is removed and 423.2063 Applicability of CMS rulings.
§ 423.558 Scope. reserved. 423.2100 Medicare Appeals Council (MAC)
(a) This subpart sets forth the Review: General.
requirements relating to the following: § 423.630 [Removed and Reserved] 423.2102 Request for MAC review when an
(1) Part D plan sponsors with respect 12. Section 423.630 is removed and ALJ issues decision or dismissal.
to grievances, coverage determinations, 423.2106 Where a request for review may
reserved.
be filed.
and redeterminations. 423.2108 MAC Actions when request for
(2) Part D IRE with respect to § 423.634 [Removed and Reserved]
review is filed.
reconsiderations; and 13. Section 423.634 is removed and 423.2110 MAC reviews on its own motion.
(3) Part D enrollees’ rights with reserved. 423.2112 Content of request for review.
respect to grievances, coverage 14. A new subpart U is added to read 423.2114 Dismissal of request for review.
determinations, redeterminations, and as follows: 423.2116 Effect of dismissal of request for
reconsiderations. Subpart U—Reopening, ALJ Hearings, MAC MAC review or request for hearing.
(b) The requirements regarding Review, and Judicial Review 423.2118 Obtaining evidence from the
Reopenings, ALJ Hearings, MAC review, MAC.
Sec. 423.2120 Filing briefs with the MAC.
and Judicial Review are set forth in 423.1968 Scope.
subpart U of this chapter. 423.2122 What evidence may be submitted
423.1970 Right to an ALJ hearing. to the MAC.
§ 423.562 [Amended] 423.1972 Request for an ALJ hearing. 423.2124 Oral arguments.
423.1974 Medicare Appeals Council (MAC) 423.2126 Case remanded by the MAC.
4. In § 423.562— review.
A. In paragraph (b)(4)(iv), the cross- 423.2128 Action of the MAC.
423.1976 Judicial review. 423.2130 Effect of the MAC’s decision.
reference to ‘‘§ 423.610’’ is removed and 423.1978 Reopening and revising 423.2134 Extension of time to file action in
the cross-reference to ‘‘§ 423.1970’’ is determinations and decisions. Federal District Court.
added in its place. 423.1980 Reopening of coverage 423.2136 Judicial review.
B. In paragraph (b)(4)(v), the cross- determinations, redeterminations, 423.2138 Case remanded by a Federal
reference to ‘‘§ 423.620’’ is removed and reconsiderations, hearings and reviews. District Court.
the cross-reference to ‘‘§ 423.1974’’ is 493.1982 Notice of a revised determination 423.2140 MAC review of ALJ decision in a
added in its place. or decision. case remanded by a Federal District
C. In paragraph (b)(4)(vi), the cross- 423.1984 Effect of a revised determination Court.
or decision.
reference to ‘‘§ 423.630’’ is removed and
423.1986 Good cause for reopening. Subpart U—Reopening, ALJ Hearings,
the cross-reference to ‘‘§ 423.1976’’ is 423.1990 Expedited access to judicial
added in its place. MAC Review, and Judicial Review
review.
423.2000 Hearing before an ALJ: General § 423.1968 Scope.
§ 423.576 [Amended]
rule. This subpart sets forth the
5. In § 423.576— 423.2002 Right to an ALJ hearing.
A. The cross-reference to ‘‘§ 423.580 423.2004 Right to ALJ review of IRE notice
requirements relating to the following:
through § 423.630’’ is removed and the of dismissal. (a) Part D sponsors, the Part D IRE,
cross-references to ‘‘§ 423.580 through 423.2008 Parties to an ALJ hearing. ALJs, and the MAC with respect to
§ 423.604 and § 423.1970 through 423.2010 When CMS, the IRE, or Part D reopenings.
§ 423.1976’’ are added in its place. Plan Sponsors may participate in an ALJ (b) ALJs with respect to hearings.
B. The cross-reference to ‘‘423.634’’ is hearing. (c) MAC with respect to review of part
removed and the cross-reference to 423.2014 Request for an ALJ hearing. D appeals.
423.2016 Timeframes for deciding an (d) Part D enrollees’ rights with
‘‘§ 423.1978’’ is added in its place.
Appeal before an ALJ. respect to reopenings, ALJ hearings,
§ 423.580 [Amended] 423.2018 Submitting evidence before the MAC reviews, and judicial review by a
ALJ hearing.
6. In § 423.580, the cross-reference to Federal District Court.
423.2020 Time and Place for a Hearing
‘‘§ 423.634’’ is removed, and the cross- before an ALJ. § 423.1970 Right to an ALJ hearing.
reference to ‘‘§ 423.1978’’ is added in its 423.2022 Notice of a hearing before an ALJ.
place. 423.2024 Objections to the issues. (a) If the amount remaining in
423.2026 Disqualification of the ALJ. controversy after the IRE
§ 423.602 [Amended] 423.2030 ALJ hearing procedures. reconsideration meets the threshold
7. In § 423.602(b)(2), the cross- 423.2032 Issues before an ALJ. requirement established annually by the
reference to ‘‘§ 423.610’’ is removed, 423.2034 When an ALJ may remand a case. Secretary, an enrollee who is
dissatisfied with the IRE reconsideration rule on the substantive issues raised in (i) A Part D plan sponsor to revise the
determination has a right to a hearing the appeal. coverage determination or
before an ALJ. redetermination;
(b) If the basis for the appeal is the § 423.1974 Medicare Appeals Council (ii) An IRE to revise the
(MAC) review.
refusal by the Part D plan sponsor to reconsideration;
provide drug benefits, CMS uses the An enrollee who is dissatisfied with (iii) An ALJ to revise the hearing
projected value of those benefits to an ALJ hearing decision may request decision; or
compute the amount remaining in that the MAC review the ALJ’s decision (iv) The MAC to revise the hearing or
controversy. The projected value of a or dismissal as provided in § 423.2102. review decision.
Part D drug or drugs shall include any (2) When an enrollee has filed a valid
§ 423.1976 Judicial review.
costs the enrollee could incur based on request for an appeal of a coverage
(a) Review of ALJ’s decision. The determination, redetermination,
the number of refills prescribed for the enrollee may request judicial review of
drug(s) in dispute during the plan year. reconsideration, hearing, or MAC
an ALJ’s decision if— review, no adjudicator has jurisdiction
(c) Aggregating appeals to meet the (1) The MAC denied the enrollee’s
amount in controversy—(1) Enrollee. to reopen an issue that is under appeal
request for review; and until all appeal rights for that issue are
Two or more appeals may be aggregated (2) The amount in controversy meets
by an enrollee to meet the amount in exhausted. Once the appeal rights for
the threshold requirement established
controversy for an ALJ hearing if— the issue have been exhausted, the Part
annually by the Secretary.
(i) The appeals have previously been D plan sponsor, IRE, ALJ, or MAC may
(b) Review of MAC decision. The
reconsidered by an IRE; reopen as set forth in this section.
enrollee may request judicial review of
(ii) The request for ALJ hearing lists (3) Consistent with § 423.1978(b), the
the MAC decision if it is the final
all of the appeals to be aggregated and filing of a request for reopening does not
decision of CMS and the amount in
each aggregated appeal meets the filing relieve the Part D plan sponsor of its
controversy meets the threshold
requirement specified in § 423.1972(b); obligation to make payment or provide
established in paragraph (a)(2) of this
and benefits as specified in § 423.636 or
section.
(iii) The ALJ determines that the § 423.638.
(c) How to request judicial review. In
appeals the enrollee seeks to aggregate (4) Consistent with § 423.1978(d), the
order to request judicial review, an
involve the delivery of prescription Part D plan sponsor’s, IRE’s, ALJ’s, or
enrollee must file a civil action in a
drugs to a single enrollee. MAC’s decision on whether to reopen is
district court of the United States in
(2) Multiple enrollees. Two or more final and not subject to appeal.
accordance with section 205(g) of the (5) A determination under the
appeals may be aggregated by multiple Act. (See § 423.2136 for a description of
enrollees to meet the amount in Medicare secondary payer provisions of
the procedures to follow in requesting section 1862(b) of the Act that Medicare
controversy for an ALJ hearing if— judicial review.)
(i) The appeals have previously been has an MSP recovery claim for drug
reconsidered by an IRE; § 423.1978 Reopening and revising claims that were already reimbursed by
(ii) The request for ALJ hearing lists determinations and decisions. the Part D plan sponsor is not a
all of the appeals to be aggregated and (a) A coverage determination or reopening.
each aggregated appeal meets the filing redetermination made by a Part D plan (b) Timeframes and requirements for
requirement specified in § 423.1972(b); sponsor, a reconsideration made by the reopening coverage determinations and
and independent review entity specified in redeterminations initiated by a Part D
(iii) The ALJ determines that the § 423.600, or the decision of an ALJ or plan sponsor. A Part D plan sponsor
appeals the enrollees seek to aggregate the MAC that is otherwise final and may reopen and revise its coverage
involve the same prescription drug. binding may be reopened and revised by determination or redetermination on its
the entity that made the determination own motion—
§ 423.1972 Request for an ALJ hearing. (1) Within 1 year from the date of the
or decision as provided in § 423.1980
(a) How and where to file a request. coverage determination or
through § 423.1986.
The enrollee must file a written request (b) The filing of a request for redetermination for any reason.
for a hearing with the entity specified in reopening does not relieve the Part D (2) Within 4 years from the date of the
the IRE’s reconsideration notice. plan sponsor of its obligation to make coverage determination or
(b) When to file a request. Except redetermination for good cause as
payment or provide benefits as specified
when an ALJ extends the timeframe as defined in § 423.1986.
in § 423.636 or § 423.638 of this chapter.
provided in § 423.2014(d), the enrollee (c) Once an entity issues a revised (3) At any time if there exists reliable
must file a request for a hearing within determination or decision, the revisions evidence as defined in § 405.902 that
60 days of the date of the notice of an made by the decision may be appealed. the coverage determination was
IRE reconsideration determination. The (d) A decision not to reopen by the procured by fraud or similar fault as
time and place for a hearing before an Part D plan sponsor or any other entity defined in § 405.902.
ALJ will be set in accordance with is not subject to review. (c) Timeframe and requirements for
§ 423.2020 of this chapter. reopening coverage determinations and
(c) Insufficient amount in controversy. § 423.1980 Reopenings of coverage redeterminations requested by an
(1) If a request for a hearing clearly determinations, redeterminations, enrollee. (1) An enrollee may request
shows that the amount in controversy is reconsiderations, hearings and reviews. that a Part D plan sponsor reopen its
less than that required under (a) General rules. (1) A reopening is a coverage determination or
§ 423.1970, the ALJ dismisses the remedial action taken to change a final redetermination within 1 year from the
request. determination or decision, even though date of the coverage determination or

(2) If, after a hearing is initiated, the the final determination or decision may redetermination for any reason.
ALJ finds that the amount in have been correct at the time it was (2) An enrollee may request that a Part
controversy is less than the amount made based on the evidence of record. D plan sponsor reopen its coverage
required under § 423.1970, the ALJ Consistent with § 423.1978(a), that determination or redetermination
discontinues the hearing and does not action may be taken by— within 4 years from the date of the
coverage determination or (b) Reopenings initiated at the request (ii) May result in a different
redetermination for good cause in of an enrollee. (1) The Part D plan conclusion; or
accordance with § 423.1986. sponsor, IRE, ALJ, or the MAC must (2) The evidence that was considered
(d) Timeframes and requirements for mail its revised determination or in making the determination or decision
reopening reconsiderations, hearing decision to the enrollee at his or her last clearly shows on its face that an obvious
decisions and reviews initiated by an known address. error was made at the time of the
IRE, ALJ, or the MAC. (1) An IRE may (2) The IRE, ALJ, or the MAC must determination or decision.
reopen its reconsideration on its own mail its revised determination or (b) Change in substantive law or
motion within 180 days from the date of decision to the Part D plan sponsor. interpretative policy—(1) General rule.
the reconsideration for good cause in (3) An adverse revised determination A change of legal interpretation or
accordance with § 423.1986. If the IRE’s or decision must state the rationale and policy by CMS in a regulation, CMS
reconsideration was procured by fraud basis for the reopening and revision and ruling, or CMS general instruction,
or similar fault, then the IRE may any right to appeal. whether made in response to judicial
reopen at any time. precedent or otherwise, is not a basis for
(2) An ALJ or the MAC may reopen § 423.1984 Effect of a revised
determination or decision. reopening a determination or hearing
a hearing decision on its own motion decision regarding appeals under this
within 180 days from the date of the (a) Coverage determinations. The
section.
decision for good cause in accordance revision of a coverage determination is
(2) An adjudicator may reopen a
with § 423.1986. If the hearing decision binding unless an enrollee submits a
determination or decision to apply the
was procured by fraud or similar fault, request for a redetermination that is
current law or CMS or the Part D plan
then the ALJ or the MAC may reopen at accepted and processed in accordance
sponsor policy rather than the law or
any time. with § 423.580 through § 423.590.
(b) Redeterminations. The revision of CMS or the Part D plan sponsor policy
(3) The MAC may reopen its review at the time the coverage determination
decision on its own motion within 180 a redetermination is binding unless an
enrollee submits a request for an IRE is made in situations where the enrollee
days from the date of the review has not yet received the drug and the
decision for good cause in accordance reconsideration that is accepted and
processed in accordance with § 423.600 current law or CMS or the Part D plan
with § 423.1986. If the MAC’s decision sponsor policy may affect whether the
was procured by fraud or similar fault, through § 423.604.
(c) Reconsiderations. The revision of drug should be received.
then the MAC may reopen at any time. (c) Third party payer error. A request
(e) Timeframes and requirements for a reconsideration is binding unless an
enrollee submits a request for an ALJ to reopen a claim based upon a third
reopening reconsiderations, hearing party payer’s error in making a primary
decisions, and reviews requested by an hearing that is accepted and processed
in accordance with § 423.1970 through payment determination when Medicare
enrollee. (1) An enrollee who received a processed the claim in accordance with
reconsideration may request that an IRE § 423.1972 and § 423.2000 through
§ 423.2063. the information in its system of records
reopen its reconsideration within 180 or on the claim form does not constitute
days from the date of the (d) ALJ hearing decisions. The
revision of a hearing decision is binding good cause for reopening.
reconsideration for good cause in
accordance with § 423.1986. unless an enrollee submits a request for § 423.1990 Expedited access to judicial
(2) An enrollee who received an ALJ a MAC review that is accepted and review.
hearing decision may request that an processed as specified in § 423.1974 and (a) Process for expedited access to
ALJ or the MAC reopen the hearing § 423.2100 through § 423.2130. judicial review.
decision within 180 days from the date (e) MAC review. The revision of a
(1) For purposes of this section, a
of the hearing decision for good cause MAC determination or decision is
‘‘review entity’’ means an entity of up
in accordance with § 423.1986. binding unless an enrollee files a civil
to three reviewers who are ALJs or
(3) An enrollee who received a MAC action in which a Federal District Court
members of the Departmental Appeals
decision may request that the MAC accepts jurisdiction and issues a
Board, as determined by the Secretary.
reopen its decision within 180 days decision.
(f) Appeal of only the portion of the (2) In order to obtain expedited access
from the date of the review decision for to judicial review (EAJR), a review
good cause in accordance with determination or decision revised by the
reopening. Only the portion of the entity must certify that the MAC does
§ 423.1986. not have the authority to decide the
coverage determination,
§ 423.1982 Notice of a revised redetermination, reconsideration, or question of law or regulation relevant to
determination or decision. hearing decision revised by the the matters in dispute and that there is
(a) When adjudicators initiate reopening may be subsequently no material issue of fact in dispute.
reopenings. When any determination or appealed. (3) An enrollee may make a request
decision is reopened and revised as (g) Effect of a revised determination or for EAJR only once with respect to a
provided in § 423.1980— decision. Consistent with § 423.1978(c), question of law or regulation for a
(1) The Part D plan sponsor, IRE, ALJ, a revised determination or decision is specific matter in dispute in an appeal.
or the MAC must mail its revised binding unless it is appealed or (b) Conditions for making the
determination or decision to the otherwise reopened. expedited appeals request. (1) An
enrollee at his or her last known enrollee may request EAJR in place of
address. § 423.1986 Good cause for reopening. an ALJ hearing or MAC review if the
(2) The IRE, ALJ, or the MAC must (a) Establishing good cause. Good following conditions are met:
mail its revised determination or cause may be established when— (i) An IRE has made a reconsideration
decision to the Part D plan sponsor. (1) There is new and material determination and the enrollee has filed
(3) An adverse revised determination evidence that— a request for an ALJ hearing in
or decision must state the rationale and (i) Was not available or known at the accordance with § 423.2002 and a final
basis for the reopening and revision and time of the determination or decision; decision of the ALJ has not been issued;
any right to appeal. and or
(ii) An ALJ has made a decision and (ii) If the enrollee has requested MAC 205(g) of the Act, as well as the
the enrollee has filed a request for MAC review, at any time before receipt of requirements for filing a civil action in
review in accordance with § 423.2102 notice of the MAC’s decision. a Federal District Court under
and a final decision of the MAC has not (e) Determination on EAJR request. (1) § 423.2136.
been issued. The review entity described in (h) Rejection of EAJR. (1) If a request
(2) The requestor is an enrollee. paragraph (a) of this section will for EAJR does not meet all the
(3) The amount remaining in determine whether the request for EAJR conditions set out in paragraphs (b), (c),
controversy meets the threshold meets all of the requirements of and (d) of this section, or if the review
requirements established annually by paragraphs (b), (c), and (d) of this entity does not certify a request for
the Secretary. section. EAJR, the review entity advises the
(4) If there is more than one enrollee (2) Within 60 days after the date the enrollee in writing that the request has
to the hearing or MAC review, each review entity receives a request and been denied, and returns the request to
enrollee concurs, in writing, with the accompanying documents and materials the ALJ hearing office or the MAC,
request for the EAJR. meeting the conditions in paragraphs which will treat it as a request for
(5) There are no material issues of fact (b), (c), and (d) of this section, the hearing or for MAC review, as
in dispute. review entity will issue either a appropriate.
(c) Content of the request for EAJR. certification in accordance with (2) Whenever a review entity forwards
The request for EAJR must— paragraph (f) of this section or a denial a rejected EAJR request to an ALJ
(1) Allege that there are no material of the request. hearing office or the MAC, the appeal is
issues of fact in dispute and identify the (3) A determination by the review considered timely filed and the 90-day
facts that the enrollee considers material entity either certifying that the decision making timeframe begins on
and that are not disputed; and requirements for EAJR are met pursuant the day the request is received by the
(2) Assert that the only factor to paragraph (f) of this section or hearing office or the MAC.
precluding a decision favorable to the denying the request is final and not
subject to review by the Secretary. § 423.2000 Hearing before an ALJ: General
enrollee is— rule.
(i) A statutory provision that is (4) If the review entity fails to make
a determination within the timeframe (a) If an enrollee is dissatisfied with
unconstitutional, or a provision of a an IRE’s reconsideration, the enrollee
regulation that is invalid and specify the specified in paragraph (e)(2) of this
section, then the enrollee may bring a may request a hearing.
statutory provision that the enrollee (b) A hearing may be conducted in
considers unconstitutional or the civil action in Federal District Court
within 60 days of the end of the person, by video-teleconference, or by
provision of a regulation that the telephone. At the hearing, the enrollee
enrollee considers invalid, or timeframe.
(f) Certification by the review entity. If may submit evidence subject to the
(ii) A CMS Ruling that the enrollee restrictions in § 423.2018, examine the
considers invalid. an enrollee meets the requirements for
the EAJR, the review entity certifies in evidence used in making the
(3) Include a copy of the IRE determination under review, and
writing that—
reconsideration and of any ALJ hearing present and/or question witnesses.
(1) The material facts involved in the
decision that the enrollee has received; (c) In some circumstances, the Part D
appeal are not in dispute;
(4) If the IRE reconsideration or ALJ (2) Except as indicated in paragraph plan sponsor, or a representative of
hearing decision was based on facts that (f)(3) of this section, the Secretary’s CMS, including the IRE, may participate
the enrollee is disputing, state why the interpretation of the law is not in in the hearing as specified in
enrollee considers those facts to be dispute; § 423.2010.
immaterial; and (3) The sole issue(s) in dispute is the (d) The ALJ issues a decision based on
(5) If the IRE reconsideration or ALJ constitutionality of a statutory the hearing record.
hearing decision was based on a provision, or the validity of a provision (e) If an enrollee waives his or her
provision of a law, regulation, or CMS of a regulation or CMS Ruling; right to appear at the hearing in person
Ruling in addition to the one the (4) But for the provision challenged, or by telephone or video-teleconference,
enrollee considers unconstitutional or the enrollee would receive a favorable the ALJ may make a decision based on
invalid, a statement as to why further decision on the ultimate issue; and the evidence that is in the file and any
administrative review of how that (5) The certification by the review new evidence that is submitted for
provision applies to the facts is not entity is the Secretary’s final action for consideration.
necessary. purposes of seeking expedited judicial (f) The ALJ may require the enrollee
(d) Place and time for an EAJR review. to participate in a hearing if it is
request. (1) Method and place for filing (g) Effect of certification by the review necessary to decide the case. If the ALJ
request. The enrollee may include an entity. If an EAJR request results in a determines that it is necessary to obtain
EAJR request in his or her request for an certification described in paragraph (f) testimony from a person other than the
ALJ hearing or MAC review, or, if an of this section— enrollee, he or she may hold a hearing
appeal is already pending with an ALJ (1) The enrollee that requested the to obtain that testimony, even if the
or the MAC, file a written EAJR request EAJR is considered to have waived any enrollee has waived the right to appear.
with the ALJ hearing office or MAC right to completion of the remaining In that event, however, the ALJ will give
where the appeal is being considered. steps of the administrative appeals the enrollee the opportunity to appear
The ALJ hearing office or MAC forwards process regarding the matter certified. when the testimony is given, but may
the request to the review entity within (2) The enrollee has 60 days, hold the hearing even if the enrollee
5 days of receipt. beginning on the date of the review decides not to appear.
(2) Time of filing request. The entity’s certification within which to (g) An ALJ may also issue a decision
enrollee may file a request for EAJR— bring a civil action in Federal District on the record on his or her own
(i) If the enrollee has requested a Court. initiative if the evidence in the hearing
hearing, at any time before receipt of the (3) The enrollee must satisfy the record supports a fully favorable
notice of the ALJ’s decision; or requirements for venue under section finding.
§ 423.2002 Right to an ALJ hearing. (c) An ALJ’s decision regarding an (g) The ALJ cannot draw any adverse
(a) Consistent with § 423.1970(a), an IRE’s dismissal of a reconsideration inferences if CMS, the IRE, and/or the
enrollee may request a hearing before an request is final and not subject to further Part D plan sponsor decide not to
ALJ if— review. participate in any proceedings before an
(1) The enrollee files a written request ALJ, including the hearing.
§ 423.2008 Parties to an ALJ hearing.
for an ALJ hearing within 60 days after
(a) Who may request a hearing. Only § 423.2014 Request for an ALJ hearing.
receipt of the written notice of the IRE’s
reconsideration; and an enrollee (or an enrollee’s (a) Content of the request. The request
(2) The enrollee meets the amount in representative) may request a hearing for an ALJ hearing must be made in
controversy requirements of § 423.1970. before an ALJ. writing, except as set forth in paragraph
(b) An enrollee may request that the (b) Who are parties to the ALJ hearing. (b) of this section. The request,
hearing before an ALJ be expedited if: The enrollee (or the enrollee’s including any oral request, must include
(1) The appeal involves an issue representative) who filed the request for all of the following—
specified in § 423.566(b) but does not hearing is the only party to the ALJ (1) The name, address, telephone
include solely a request for payment of hearing. number, and Medicare health insurance
Part D drugs already furnished; claim number of the enrollee.
§ 423.2010 When CMS, the IRE, or Part D (2) The name, address, and telephone
(2) The enrollee submits a written or plan sponsors may participate in an ALJ
oral request for an expedited ALJ number of the appointed representative,
hearing.
hearing within 60 days of the date of the as defined at § 423.560, if any.
(a) An ALJ may request, but may not (3) The appeals case number assigned
written notice of an IRE reconsideration
require, CMS, the IRE, and/or the Part to the appeal by the IRE, if any.
determination. The request can only be
D plan sponsor to participate in any (4) The prescription drug in dispute.
submitted after the enrollee receives the
proceedings before the ALJ, including (5) The plan name.
written IRE reconsideration notice. The
the oral hearing, if any. (6) The reasons the enrollee disagrees
request should also explain why
(b) CMS, the IRE, and/or the Part D with the IRE’s reconsideration.
applying the standard timeframe may
plan sponsor may request to participate (7) A statement of any additional
seriously jeopardize the life or health of
in the hearing process. evidence to be submitted and the date
the enrollee; and (1) For non-expedited hearings, any
(3) The enrollee meets the amount in it will be submitted.
request by CMS, the IRE, and/or the Part (8) A statement that the enrollee is
controversy requirements of § 423.1970.
D plan sponsor to participate must be requesting an expedited hearing, if
The ALJ must document all oral
made within 5 days of receipt of the applicable.
requests for expedited hearings in
notice of hearing. (b) Request for expedited hearing. If
writing and maintain the documentation
(2) Within 5 days of receipt of a an enrollee is requesting that the
in the case files.
request to participate in a non-expedited hearing be expedited, the enrollee may
(c) For purposes of this section, the
hearing, the ALJ must notify the entity, make the request for an ALJ hearing
date of receipt of the reconsideration is
the Part D plan sponsor, if applicable orally, but only after receipt of the
presumed to be 5 days after the date of
and the enrollee of his or her decision written IRE reconsideration notice. The
the written reconsideration, unless there
on the request to participate. ALJ hearing office must document all
is evidence to the contrary.
(3) For expedited hearings, any oral requests in writing and maintain
(d) For purposes of meeting the 60-
request by CMS, the IRE, and/or the Part the documentation in the case files. A
day filing deadline, the request is
D plan sponsor to participate must be prescribing physician may provide oral
considered as filed on the date it is
made within 1 day of receipt of the or written support for an enrollee’s
received by the entity specified in the
notice of hearing. Requests may be made request for expedited review.
IRE’s reconsideration.
orally or submitted by facsimile to the (c) When and where to file. Consistent
§ 423.2004 Right to ALJ review of IRE hearing office. with § 423.1972(a) and (b), the request
notice of dismissal. (4) Within 1 day of receipt of a request for an ALJ hearing after an IRE
(a) An enrollee has a right to have an to participate in an expedited hearing, reconsideration must be submitted—
IRE’s dismissal of a request for the ALJ must notify the entity, the Part (1) Within 60 days from the date the
reconsideration reviewed by an ALJ if— D plan sponsor, if applicable, and the enrollee receives written notice of the
(1) The enrollee files a request for an enrollee of his or her decision on the IRE’s reconsideration;
ALJ review within 60 days after receipt request to participate. (2) With the entity specified in the
of the written notice of the IRE’s (c) The ALJ has discretion not to IRE’s reconsideration.
dismissal. allow CMS, the IRE, and/or the Part D (i) If the request for hearing is timely
(2) The enrollee meets the amount in plan sponsor to participate. filed with an entity other than the entity
controversy requirements of § 423.1970. (d) Participation may include filing specified in the IRE’s reconsideration,
(3) For purposes of this section, the position papers or providing written the deadline specified in § 423.2016 for
date of receipt of the IRE’s dismissal is testimony to clarify factual or policy deciding the appeal begins on the date
presumed to be 5 days after the date of issues in a case, but it does not include the entity specified in the IRE’s
the written dismissal notice, unless calling witnesses or cross-examining the reconsideration receives the request for
there is evidence to the contrary. witnesses of an enrollee to the hearing. hearing.
(4) For purposes of meeting the 60- (e) When CMS, the IRE, and/or the (ii) If the request for hearing is filed
day filing deadline, the request is Part D plan sponsor participates in an with an entity, other than the entity
considered as filed on the date it is ALJ hearing, CMS, the IRE, and/or the specified in the IRE’s reconsideration,
received by the entity specified in the Part D plan sponsor may not be called the ALJ hearing office must notify the
IRE’s dismissal. as a witness during the hearing. appellant of the date of receipt of the
(b) If the ALJ determines that the IRE’s (f) CMS, the IRE, and/or the Part D request and the commencement of the
dismissal was in error, he or she vacates plan sponsor must submit any position adjudication timeframe.
the dismissal and remands the case to papers within the timeframe designated (d) Extension of time to request a
the IRE for a reconsideration. by the ALJ. hearing. (1) Consistent with
§ 423.1972(b), if the request for hearing (2) Grant of a request. If the ALJ condition after the coverage
is not filed within 60 days of receipt of grants a request for expedited hearing, determination to be considered.
the written IRE’s reconsideration, an the ALJ must: (b) Non-expedited hearings. (1) Except
enrollee may request an extension for (i) Make the decision to grant an as provided in this paragraph, an
good cause. expedited hearing within 5 days of enrollee must submit all written
(2) Any request for an extension of receipt of the request for expedited evidence he or she wishes to have
time must be in writing or, for expedited hearing; considered at the hearing with the
reviews, in writing or oral. The ALJ (ii) Give the enrollee prompt oral request for hearing or within 10 days of
hearing office must document all oral notice of this decision; and receiving the notice of hearing.
requests in writing and maintain the (iii) Subsequently send to the enrollee (2) If an enrollee submits written
documentation in the case file. at his or her last known address and to evidence later than 10 days after
the Part D plan sponsor written notice receiving the notice of hearing, the
(3) The request must give the reasons of the decision. This notice may be period between the time the evidence
why the request for a hearing was not provided within the written notice of was required to have been submitted
filed within the stated time period, and hearing. and the time it is received is not
must be filed with the entity specified (3) Denial of a request. If the ALJ counted toward the adjudication
in the notice of reconsideration. denies a request for expedited hearing, deadline specified in § 423.2016.
(4) If the ALJ finds there is good cause the ALJ must: (c) Expedited hearings. (1) Except as
for missing the deadline, the time (i) Make this decision within 5 days provided in this section, an enrollee
period for filing the hearing request will of receipt of the request for expedited must submit all written evidence he or
be extended. To determine whether hearing; she wishes to have considered at the
good cause for late filing exists, the ALJ (ii) Give the enrollee prompt oral hearing with the request for hearing or
uses the standards set forth in notice of the denial that informs the within 2 days of receiving the notice of
§ 405.942(b)(2) and (b)(3) of this chapter. enrollee of the denial and explains that hearing.
(5) If a request for hearing is not the ALJ will process the enrollee’s (2) If an enrollee submits written
timely filed, the adjudication period in request using the 90-day timeframe for evidence later than 2 days after
§ 423.2016 begins the date the ALJ non-expedited ALJ hearings; and receiving the notice of hearing, the
grants the request to extend the filing (iii) Subsequently send to the enrollee period between the time the evidence
deadline. at his or her last known address and to was required to have been submitted
the Part D plan sponsor an equivalent and the time it is received is not
§ 423.2016 Timeframes for deciding an written notice of the decision within 3 counted toward the adjudication
Appeal before an ALJ. days after the oral notice. deadline specified in § 423.2016.
(a) Hearings. (1) When a request for an (4) A decision on a request for (d) The requirements of paragraphs (b)
ALJ hearing is filed after an IRE has expedited hearing may not be appealed. and (c) of this section do not apply to
issued a written reconsideration, the (5) Timeframe for adjudication. (i) If oral testimony given at a hearing.
ALJ must issue a decision, dismissal the ALJ accepts a request for expedited
order, or remand, as appropriate, no hearing, the ALJ must issue a written § 423.2020 Time and place for a hearing
decision, dismissal order or remand, as before an ALJ.
later than the end of the 90-day period
beginning on the date the request for expeditiously as the enrollee’s health (a) General. Consistent with
hearing is received by the entity condition requires, but no later than the § 423.1972(b), the ALJ sets the time and
specified in the IRE’s notice of end of the 10-day period beginning on place for the hearing, and may change
reconsideration, unless the 90-day the date the request for hearing is the time and place, if necessary.
period has been extended as provided in received by the entity specified in the (b) Determining how appearances are
this subpart. IRE’s written notice of reconsideration, made. (1) The ALJ will direct that the
unless the 10-day period has been appearance of an individual be
(2) The adjudication period specified conducted by video-teleconferencing if
in paragraph (a) of this section begins on extended as provided in this subpart.
(ii) The adjudication period specified the ALJ finds that video-
the date that a timely filed request for teleconferencing technology is available
hearing is received by the entity in paragraph (b)(5)(i) of this section
begins on the date that a timely to conduct the appearance.
specified in the IRE’s reconsideration, (2) The ALJ may also offer to conduct
or, if it is not timely filed, the date that provided request for hearing is received
by the entity specified in the IRE’s a hearing by telephone if the request for
the ALJ grants any extension to the hearing or administrative record
filing deadline. reconsideration, or, if it is not timely
provided, the date that the ALJ grants suggests that a telephone hearing may
(b) Expedited hearings. (1) Standard any extension to the filing deadline. be more convenient for the enrollee.
for expedited hearing. The ALJ must (3) The ALJ, with the concurrence of
provide an expedited hearing decision if § 423.2018 Submitting evidence before the the Managing Field Office ALJ, may
the appeal involves an issue specified in ALJ hearing. determine that an in-person hearing
§ 423.566(b), but is not solely a request (a) All hearings. An enrollee may should be conducted if—
for payment of Part D drugs already submit any written evidence that he or (i) The video-teleconferencing
furnished, and the enrollee’s prescribing she wishes to have considered at the technology is not available; or
physician indicates, or the ALJ hearing. (ii) Special or extraordinary
determines that applying the standard (1) An ALJ will not consider any circumstances exist.
timeframe for making a decision may evidence submitted regarding a change (c) Notice of hearing. (1) The ALJ
seriously jeopardize the enrollee’s life, in condition of an enrollee after the sends a notice of hearing to the enrollee,
health or ability to regain maximum appealed coverage determination was the Part D plan sponsor that issued the
function. The ALJ may consider this made. coverage determination, and the IRE
standard as met if a lower level (2) An ALJ will remand a case to the that issued the reconsideration, advising
adjudicator has granted a request for an Part D plan sponsor where an enrollee them of the proposed time and place of
expedited hearing. wishes evidence on his or her change in the hearing.
(2) The notice of hearing will require condition, incapacitating injury, or earliest possible opportunity before the
the enrollee (and any potential death in the family; or time set for the hearing and request an
participant from CMS, the IRE, and/or (2) Severe weather conditions make it in-person hearing.
the Part D plan who has requested to impossible to travel to the hearing; or (2) The enrollee must state the reason
participate in the hearing consistent (3) Good cause exists as set forth in for the objection and state the time or
with § 423.2010) to reply to the notice paragraph (g) of this section. place he or she wants the hearing to be
by: (g) Good cause in other held.
(i) Acknowledging whether they plan circumstances. (1) In determining (3) The request must be in writing
to attend the hearing at the time and whether good cause exists in except for an expedited hearing for
place proposed in the notice of hearing; circumstances other than those set forth which the request may be provided
or in paragraph (f) of this section, the ALJ orally. The ALJ must document all oral
(ii) Objecting to the proposed time considers the enrollee’s reason for objections to an expedited video-
and/or place of the hearing. requesting the change, the facts teleconferencing or telephone hearing in
(d) An enrollee’s right to waive a supporting the request, and the impact writing and maintain the documentation
hearing. An enrollee may also waive the of the proposed change on the efficient in the case files.
right to a hearing and request that the administration of the hearing process. (4) When an enrollee’s request for an
ALJ issue a decision based on the (2) Factors evaluated to determine the in-person hearing is granted, the
written evidence in the record. impact of the change include, but are enrollee is deemed to have waived the
(1) As specified in § 423.2000, the ALJ not limited to, the effect on processing adjudicatory timeframe as specified in
may require the enrollee to attend a other scheduled hearings, potential § 423.2016, except if the ALJ has granted
hearing if it is necessary to decide the delays in rescheduling the hearing, and the enrollee’s request for an expedited
case. whether any prior changes were granted appeal.
(2) If the ALJ determines that it is the enrollee. (5) The ALJ may grant the request,
necessary to obtain testimony from a (3) Examples of other circumstances with the concurrence of the Managing
person other than the enrollee, he or she an enrollee might give for requesting a Field Office ALJ, upon a finding of good
may still hold a hearing to obtain that change in the time or place of the cause and will reschedule the hearing
testimony, even if the enrollee has hearing include, but are not limited to, for a time and place when the enrollee
waived the right to appear. In those the following: may appear in person before the ALJ.
cases, the ALJ would give the enrollee (i) The enrollee has attempted to
the opportunity to appear when the obtain a representative but needs § 423.2022 Notice of a hearing before an
testimony is given but may hold the additional time. ALJ.
hearing even if the enrollee decides not (ii) The enrollee’s representative was (a) Issuing the notice. (1) After the ALJ
to appear. appointed within 10 days of the sets the time and place of the hearing,
(e) An enrollee’s objection to time and scheduled hearing for non-expedited the notice of the hearing will be mailed
place of hearing. (1) If an enrollee hearings (or 2 days for expedited or otherwise transmitted to the enrollee
objects to the time and place of the hearings) and needs additional time to and other potential participants, as
hearing, the enrollee must notify the prepare for the hearing. provided in § 423.2020(c) at their last
ALJ at the earliest possible opportunity (iii) The enrollee’s representative has known addresses, or given by personal
before the time set for the hearing. a prior commitment to be in court or at service, unless the enrollee has
(2) The enrollee must state the reason another administrative hearing on the indicated in writing that he or she does
for the objection and state the time and date scheduled for the hearing. not wish to receive this notice.
place he or she wants the hearing to be (iv) A witness who will testify to facts (2) The notice is mailed or served at
held. material to an enrollee’s case is least 20 days before the hearing, except
(3) The objection must be in writing unavailable to attend the scheduled for expedited hearings where written
except for an expedited hearing when hearing and the evidence cannot be notice is mailed or served at least 3 days
the objection may be provided orally. otherwise obtained. before the hearing. For expedited
The ALJ must document all oral (v) Transportation is not readily hearings, the ALJ may orally provide
objections to the time and place of an available for an enrollee to travel to the notice of the hearing to the enrollee and
expedited hearing in writing and hearing. other potential participants but oral
maintain the documentation in the case (vi) The enrollee is unrepresented, notice must be followed by an
files. and is unable to respond to the notice equivalent written notice within 1 day
(4) The ALJ may change the time or of hearing because of any physical, of the oral notice.
place of the hearing if the enrollee has mental, educational, or linguistic (b) Notice information. (1) The notice
good cause. (Section 423.2052(a)(2) limitations (including any lack of of hearing contains a statement of the
provides the procedures the ALJ follows facility with the English language). specific issues to be decided and will
when an enrollee does not respond to a (h) Effect of rescheduling hearing. If a inform the enrollee that he or she may
notice of hearing and fails to appear at hearing is postponed at the request of designate a person to represent him or
the time and place of the hearing.) the enrollee for any of the above her during the proceedings.
(f) Good cause for changing the time reasons, the time between the originally (2) The notice must include an
or place. The ALJ can find good cause scheduled hearing date and the new explanation of the procedures for
for changing the time or place of the hearing date is not counted toward the requesting a change in the time or place
scheduled hearing and reschedule the adjudication deadline as specified in of the hearing, a reminder that, if the
hearing if the information available to § 423.2016. enrollee fails to appear at the scheduled
the ALJ supports the enrollee’s (i) An enrollee’s request for an in- hearing without good cause, the ALJ
contention that— person hearing. may dismiss the hearing request, and
(1) The enrollee or his or her (1) If an enrollee objects to a video- other information about the scheduling
representative is unable to attend or to teleconferencing hearing or to the ALJ’s and conduct of the hearing.
travel to the scheduled hearing because offer to conduct a hearing by telephone, (3) The enrollee will also be told if his
of a serious physical or mental the enrollee must notify the ALJ at the or her appearance or that of any other
witness is scheduled by video- document all oral objections in writing issue; however, the ALJ may only
teleconferencing, telephone, or in and maintain the documentation in the consider a new issue if its resolution—
person. If the ALJ has scheduled the case files. The ALJ considers the (i) Could have a material impact on
enrollee to appear at the hearing by enrollee’s objections and decides the issue or issues that are the subject
video-teleconferencing, the notice of whether to proceed with the hearing or of the request for hearing; and
hearing will advise that the scheduled withdraw. (ii) Is permissible under the rules
place for the hearing is a video- (c) If the ALJ withdraws, another ALJ governing reopening of determinations
teleconferencing site and explain what will be appointed to conduct the and decisions as specified in § 423.1980.
it means to appear at the hearing by hearing. If the ALJ does not withdraw, (c) Adding issues to a pending appeal.
video-teleconferencing. the enrollee may, after the ALJ has An ALJ may not add any issue,
(4) The notice advises the enrollee issued an action in the case, present his including one that is related to an issue
that if he or she objects to appearing by or her objections to the MAC in that is appropriately before an ALJ, to a
video-teleconferencing or telephone, accordance with § 423.2100 through pending appeal unless it has been
and wishes instead to have his or her § 423.2130. The MAC would then adjudicated at the lower appeals levels
hearing at a time and place where he or consider whether the hearing decision and the enrollee is notified of the new
she may appear in person before the should be revised or a new hearing held issue(s) before the start of the hearing.
ALJ, he or she must follow the before another ALJ.
§ 423.2034 When an ALJ may remand a
procedures set forth at § 423.2020(i) for
§ 423.2030 ALJ hearing procedures. case.
notifying the ALJ of his or her objections
and for requesting an in-person hearing. (a) General rule. A hearing is open to (a) General. If an ALJ believes that the
(c) Acknowledging the notice of the enrollee and to other persons the written record is missing information
hearing. (1) If the enrollee or his or her ALJ considers necessary and proper. that is essential to resolving the issues
representative does not acknowledge (b) At the hearing. The ALJ fully on appeal and that information can be
receipt of the notice of hearing, the ALJ examines the issues, questions the provided only by CMS, the IRE, and/or
hearing office attempts to contact the enrollee and other witnesses, and may the Part D plan sponsor, then the ALJ
enrollee for an explanation. accept documents that are material to may either:
(2) If the enrollee states that he or she the issues consistent with § 423.2018. (1) Remand the case to the IRE that
did not receive the notice of hearing, an issued the reconsideration; or
(c) Missing evidence. The ALJ may
amended notice is sent to him or her by (2) Retain jurisdiction of the case and
also stop the hearing temporarily and
certified mail or, if available, fax or e- request that the CMS, the IRE, and/or
continue it at a later date if he or she
mail. See § 423.2052 for the procedures the Part D plan sponsor forward the
believes that there is material evidence
the ALJ follows in deciding if the time missing information to the appropriate
missing at the hearing.
or place of a scheduled hearing will be hearing office.
(d) Reopen the hearing. The ALJ may (b) ALJ remands a case to an IRE.
changed if an enrollee does not respond reopen the hearing at any time before he
to the notice of hearing. Consistent with § 423.2004(b), the ALJ
or she mails a notice of the decision in will remand a case to the appropriate
§ 423.2024 Objections to the issues. order to receive new and material IRE if the ALJ determines that an IRE’s
evidence pursuant to § 423.1986. The dismissal of a request for
(a) If an enrollee objects to the issues
ALJ may decide when the evidence is reconsideration was in error.
described in the notice of hearing, he or
presented and when the issues are (c) ALJ remands a case to a Part D
she must notify the ALJ in writing at the
discussed. Plan Sponsor. The ALJ will remand a
earliest possible opportunity before the
time set for the hearing, and no later § 423.2032 Issues before an ALJ. case to the Part D plan sponsor if the
than 5 days before the hearing, except ALJ determines that the enrollee wishes
(a) General rule. The issues before the
for expedited hearings in which the evidence on his or her change in
ALJ include all the issues brought out in
enrollee must submit written or oral condition after the coverage
the coverage determination,
notice of objection no later than 2 days determination to be considered in the
redetermination, or reconsideration that
before the hearing. The ALJ hearing appeal.
were not decided entirely in an
office must document all oral objections enrollee’s favor. However, if evidence § 423.2036 Description of an ALJ hearing
in writing and maintain the presented before the hearing causes the process.
documentation in the case files. ALJ to question a favorable portion of
(b) The enrollee must provide the (a) The right to appear and present
the determination, he or she notifies the evidence. (1) An enrollee has the right
reasons for his or her objections.
enrollee before the hearing and may to appear at the hearing before the ALJ
(c) The ALJ makes a decision on the
consider it an issue at the hearing. to present evidence and to state his or
objections either in writing or at the
hearing. (b) New issues—(1) General. The ALJ her position. An enrollee may appear by
may consider a new issue at the hearing video-teleconferencing, telephone, or in
§ 423.2026 Disqualification of the ALJ. if he or she notifies the enrollee about person as determined under § 423.2020.
(a) An ALJ may not conduct a hearing the new issue any time before the start (2) An enrollee may also make his or
if he or she is prejudiced or partial to of the hearing. her appearance by means of a
the enrollee or has any interest in the (2) Content of the new issues. The representative, who may make his or her
matter pending for decision. new issue may include issues resulting appearance by video-teleconferencing,
(b) If an enrollee objects to the ALJ from the participation of CMS, the IRE, telephone, or in person, as determined
who will conduct the hearing, the and/or the Part D plan sponsor at the under § 423.2020.
enrollee must notify the ALJ within 10 ALJ level of adjudication and from any (3) Witness testimony may be given
days of the date of the notice of hearing, evidence and position papers submitted and CMS, IRE, and Part D plan sponsor
except for expedited hearings in which by CMS, the IRE, and/or the Part D plan participation may also be accomplished
the enrollee must submit written or oral sponsor for the first time to the ALJ. by video-teleconferencing, telephone, or
notice no later than 2 days after the date (3) Consideration of new issues. The in person, as determined under
of the notice of hearing. The ALJ must ALJ or the enrollee may raise a new § 423.2020.
(b) Waiver of the right to appear. (1) (2) Reviewability of an ALJ Subpoena. questions relevant to the issues and
An enrollee may send the ALJ a written A subpoena issued by an ALJ is not allow the enrollee or his or her
statement indicating that he or she does subject to immediate review by the appointed representative, as defined at
not wish to appear at the hearing. MAC. The subpoena may be reviewed § 423.560.
(i) For expedited hearings, an enrollee solely during the MAC’s review
specified in § 423.2102 and § 423.2110. § 423.2038 Deciding a case without a
may indicate in writing or orally that he
(3) Exception. To the extent a hearing before an ALJ.
or she does not wish to appear at the
hearing. subpoena compels disclosure of a matter (a) Decision wholly favorable. If the
(ii) The ALJ hearing office must which an objection based on privilege, evidence in the hearing record supports
document all oral waivers in writing or other protection from disclosure such a finding in favor of the enrollee(s) on
and maintain the documentation in the as case preparation, confidentiality, or every issue, the ALJ may issue a hearing
case files. undue burden, was made before an ALJ, decision without giving the enrollee(s)
(2) The enrollee may subsequently the MAC may review immediately the prior notice and without holding a
withdraw his or her waiver in writing at ruling of the ALJ on the objections to the hearing. The notice of the decision
any time before the notice of the hearing subpoena or that portion of the informs the enrollee(s) that he or she
decision is issued; however, by subpoena as applicable. has the right to a hearing and a right to
withdrawing the waiver the enrollee (i) Upon notice to the ALJ that the examine the evidence on which the
agrees to an extension of the enrollee or a non-party, as applicable, decision is based.
adjudication period as specified in intends to seek MAC review of the ALJ’s (b) Enrollee does not wish to appear.
§ 423.2016, that may be necessary to ruling on the subpoena, the ALJ must (1) The ALJ may decide a case on the
schedule and hold the hearing. stay all proceedings affected by the record and not conduct a hearing if—
subpoena. (i) The enrollee indicates in writing
(3) Even if the enrollee waives his or
(ii) The proceedings are stayed for 15 or, for expedited hearings orally or in
her right to appear at a hearing, the ALJ
days or until the MAC issues a written writing, that he or she does not wish to
may require him or her to attend an oral
decision that affirms, reverses, or appear before the ALJ at a hearing,
hearing if the ALJ believes that a
modifies the ALJ’s subpoena, whichever including a hearing conducted by
personal appearance and testimony by
comes first. telephone or video-teleconferencing, if
the enrollee is necessary to decide the
(iii) If the MAC does not take action available. The ALJ hearing office must
case.
within the 15 days, then the stay is document all oral requests not to appear
(c) Presenting written statements and
lifted and the enrollee or non-party at a hearing in writing and maintain the
oral arguments. An enrollee or an
must comply with the ALJ’s subpoena. documentation in the case files; or
enrollee’s appointed representative, as (4) Enforcement. (i) If the ALJ (ii) The enrollee lives outside the
defined at § 423.560, may appear before determines that an enrollee or person United States and does not inform the
the ALJ to state the enrollee’s case, to other than the enrollee subject to a ALJ that he or she wants to appear.
present a written summary of the case, subpoena issued under this section has (2) When a hearing is not held, the
or to enter written statements about the refused to comply with the subpoena, decision of the ALJ must refer to the
facts and law material to the case in the the ALJ may request that the Secretary evidence in the record on which the
record. seek enforcement of the subpoena in decision was based.
(d) Waiver of adjudication period. At accordance with section 205(e) of the
any time during the hearing process, the Act, 42 U.S.C. 405(e). § 423.2040 Prehearing and posthearing
enrollee may waive the adjudication (ii) After submitting the enforcement conferences.
deadline specified in § 423.2016 for request, the time period for the ALJ to (a) The ALJ may decide on his or her
issuing a hearing decision. The waiver issue a decision, dismissal or remand a own, or at the request of the enrollee to
may be for a specific period of time case in response to a request for hearing the hearing, to hold a prehearing or
agreed upon by the ALJ and the is stayed for 15 days or until the posthearing conference to facilitate the
enrollee. Secretary makes a decision with respect hearing or the hearing decision.
(e) What evidence is admissible at a to the enforcement request, whichever (b) For non-expedited hearings, the
hearing. The ALJ may receive evidence occurs first. ALJ informs the enrollee of the time,
at the hearing even though the evidence (iii) Any enforcement request by an place, and purpose of the conference at
is not admissible in court under the ALJ must consist of a written notice to least 7 days before the conference date,
rules of evidence used by the court. the Secretary describing in detail the unless the enrollee indicates in writing
However, the ALJ may not consider ALJ’s findings of noncompliance and that he or she does not wish to receive
evidence on any change in condition of his or her specific request for a written notice of the conference.
an enrollee after a coverage enforcement, and providing a copy of (c) For expedited hearings, the ALJ
determination. If the enrollee wishes for the subpoena and evidence of its receipt informs the enrollee of the time, place,
the evidence to be considered, the ALJ by certified mail by the enrollee or and purpose of the conference at least
must remand the case to the Part D plan person other than the enrollee subject to 2 days before the conference date,
sponsor as set forth in § 423.2034(c). the subpoena. unless the enrollee indicates orally or in
(f)(1) Subpoenas. When it is (iv) The ALJ must promptly mail a writing that he or she does not wish to
reasonably necessary for the full copy of the notice and related receive a written notice of the
presentation of a case, an ALJ may, on documents to the individual or entity conference.
his or her own initiative, issue subject to the subpoena, to the enrollee, (d) The ALJ hearing office must
subpoenas for the appearance and and to any other affected person. document all oral requests not to receive
testimony of witnesses and for the (g) Witnesses at a hearing. Witnesses written notice of the conference in
enrollee and/or the Part D plan sponsor may appear at a hearing. They testify writing and maintain the documentation
to make books, records, correspondence, under oath or affirmation, unless the in the case files.
papers, or other documents that are ALJ finds an important reason to excuse (e) At the conference, the ALJ may
material to an issue at the hearing them from taking an oath or affirmation. consider matters in addition to those
available for inspection and copying. The ALJ may ask the witnesses any stated in the notice of hearing, if the
enrollee consents in writing. A record of In considering the enrollee’s request for calculated to be understood by an
the conference is made. consolidation, the ALJ must take into enrollee and must include—
(f) The ALJ issues an order stating all account the adjudication deadlines for (1) The specific reasons for the
agreements and actions resulting from each case and may require an enrollee determination, including, to the extent
the conference. If the enrollee does not to waive the adjudication deadline appropriate, a summary of any clinical
object, the agreements and actions associated with one or more cases if or scientific evidence used in making
become part of the hearing record and consolidation otherwise prevents the the determination;
are binding. ALJ from deciding all of the appeals at (2) The procedures for obtaining
issue within their respective deadlines. additional information concerning the
§ 423.2042 The administrative record.
(c) The ALJ may also propose on his decision; and
(a) Creating the record. (1) The ALJ or her own motion to consolidate two or (3) Notification of the right to appeal
makes a complete record of the more cases in one hearing for the decision to the MAC, including
evidence, including the hearing administrative efficiency, but may not instructions on how to initiate an appeal
proceedings, if any. require an enrollee to waive the under this section.
(2) The record will include marked as adjudication deadline for any of the (c) Limitation on decision. When the
exhibits, the documents used in making consolidated cases. amount of payment for the Part D drug
the decision under review, including, (d) Before consolidating a hearing, the is an issue before the ALJ, the ALJ may
but not limited to, medical records, ALJ must notify CMS of his or her make a finding as to the amount of
written statements, certificates, reports, intention to do so, and CMS may then payment due. If the ALJ makes a finding
affidavits, and any other evidence the elect to participate in the consolidated concerning payment when the amount
ALJ admits. hearing by sending written notice to the of payment was not an issue before the
(3) An enrollee may review the record ALJ. ALJ, the Part D plan sponsor may
at the hearing, or, if a hearing is not (1) For non-expedited hearings, any independently determine the payment
held, at any time before the ALJ’s notice request by CMS to participate must be amount. In either of the aforementioned
of decision is issued. made within 5 days of receipt of the situations, an ALJ’s decision is not final
(4) If a request for review is filed, the
ALJ’s notice of the consolidation. for purposes of determining the amount
complete record, including any
(2) For expedited hearings, any of payment due. The amount of
recording of the hearing, is forwarded to
request by CMS to participate must be payment determined by the Part D plan
the MAC.
made within 1 day of receipt of the sponsor in effectuating the ALJ’s
(5) A typed transcription of the
ALJ’s notice of the consolidation. decision is a new coverage
hearing is prepared if an enrollee seeks
Requests may be made orally or determination under § 423.566.
judicial review of the case in a Federal
submitted by facsimile to the hearing (d) Timing of decision. For non-
district court within the stated time
office. expedited hearings, the ALJ issues a
period and all other jurisdictional
criteria are met, unless, upon the (e) If the ALJ decides to hold a decision no later than the end of the 90-
Secretary’s motion prior to the filing of consolidated hearing, he or she may day period beginning on the date the
an answer, the court remands the case. make either a consolidated decision and request for hearing is received by the
(b) Requesting and receiving copies of record or a separate decision and record entity specified in the IRE’s
the record. (1) An enrollee may request on each issue. The ALJ ensures that any reconsideration, unless the 90-day
and receive a copy of all or part of the evidence that is common to all appeals period is extended as provided in
record, including the exhibits list, and material to the common issue to be § 423.2016. For expedited hearings, the
documentary evidence, and a copy of decided is included in the consolidated ALJ issues a decision as expeditiously
the tape of the oral proceedings. The record or each individual record, as as the enrollee’s health condition
enrollee may be asked to pay the costs applicable. requires, but no later than the end of the
of providing these items. 10-day period beginning on the date the
§ 423.2046 Notice of an ALJ decision.
(2) If an enrollee requests all or part request for hearing is received by the
(a) General rule. Unless the ALJ entity specified in the IRE’s
of the record from the ALJ and an
dismisses the hearing, the ALJ will issue reconsideration, unless the 10-day
opportunity to comment on the record,
a written decision that gives the period is extended as provided in
the time beginning with the ALJ’s
findings of fact, conclusions of law, and § 423.2016.
receipt of the request through the
the reasons for the decision. (e) Recommended decision. An ALJ
expiration of the time granted for the
(1) For expedited hearings, the ALJ issues a recommended decision if he or
enrollee’s response does not count
issues a written decision within the 10- she is directed to do so in a MAC
toward the adjudication deadline.
day adjudication timeframe under remand order. An ALJ may not issue a
§ 423.2044 Consolidated hearing before an § 423.2016(b)(5). recommended decision on his or her
ALJ. (2) The decision must be based on own motion. The ALJ mails a copy of
(a) A consolidated hearing may be evidence offered at the hearing or the recommended decision to the
held if one or more of the issues to be otherwise admitted into the record. enrollee at his or her last known
considered at the hearing are the same (3) A copy of the decision should be address.
issues that are involved in another mailed to the enrollee at his or her last
request for hearing or hearings pending known address. § 423.2048 The effect of an ALJ’s decision.
before the same ALJ. (4) A copy of the written decision The decision of the ALJ is binding on
(b) It is within the discretion of the should also be provided to the IRE that all parties to the hearing unless—
ALJ to grant or deny an enrollee’s issued the reconsideration (a) An enrollee requests a review of
request for consolidation. In considering determination, and to the Part D plan the decision by the MAC within the
an enrollee’s request, the ALJ may sponsor that issued the coverage stated time period or the MAC reviews
consider factors such as whether the determination. the decision issued by an ALJ under the
issue(s) may be more efficiently decided (b) Content of the notice. The decision procedures set forth in § 423.2110, and
if the requests for hearing are combined. must be provided in a manner the MAC issues a final action;
(b) The decision is reopened and respond within 10 days for non- § 423.2054 Effect of dismissal of a request
revised by an ALJ or the MAC under the expedited hearings; the ALJ does not for a hearing before an ALJ.
procedures explained in § 423.1980; receive the enrollee’s response within 2 The dismissal of a request for a
(c) The expedited access to judicial days for expedited hearings or the hearing is binding, unless it is vacated
review process at § 423.1990 is used; enrollee does not provide good cause for by the MAC under § 423.2108(b).
(d) The ALJ’s decision is a the failure to appear. For expedited
recommended decision directed to the hearings, an enrollee may submit his or § 423.2062 Applicability of policies not
binding on the ALJ and MAC.
MAC and the MAC issues a decision; or her response orally to the ALJ.
(e) In a case remanded by a Federal (iv) In determining whether good (a) ALJs and the MAC are not bound
District Court, the MAC assumes cause exists under paragraph (a)(2) of by CMS program guidance, such as
jurisdiction under the procedures in this section, the ALJ considers any program memoranda and manual
§ 423.2138 and the MAC issues a physical, mental, educational, or instructions, but will give substantial
decision. linguistic limitations (including any deference to these policies if they are
lack of facility with the English applicable to a particular case.
§ 423.2050 Removal of a hearing request (b) If an ALJ or MAC declines to
from an ALJ to the MAC.
language) the enrollee may have.
(3) The person requesting a hearing follow a policy in a particular case, the
If a request for hearing is pending has no right to it under § 423.2002. ALJ or MAC decision must explain the
before an ALJ, the MAC may assume reasons why the policy was not
(4) The enrollee did not request a
responsibility for holding a hearing by followed. An ALJ or MAC decision to
hearing within the stated time period
requesting that the ALJ send the hearing disregard a policy applies only to the
and the ALJ has not found good cause
request. If the MAC holds a hearing, it specific coverage determination being
for extending the deadline, as provided
conducts the hearing according to the considered and does not have
in § 423.2014(d).
rules for hearings before an ALJ. Notice precedential effect.
(5) The enrollee died while the
is mailed to the enrollee at his or her
request for hearing is pending and the § 423.2063 Applicability of CMS rulings.
last known address informing him or
request for hearing was filed by the
her that the MAC has assumed CMS Rulings are published under the
enrollee or the enrollee’s representative,
responsibility for the case. authority of the CMS Administrator.
and the enrollee’s surviving spouse or
estate has no remaining financial Consistent with § 401.108 of this
§ 423.2052 Dismissal of a request for a
interest in the case and the enrollee’s chapter, rulings are binding on all CMS
hearing before an ALJ.
representative, if any, does not want to components, and on all HHS
Dismissal of a request for a hearing is components that adjudicate matters
in accordance with the following: continue the appeal.
under the jurisdiction of CMS.
(a) An ALJ dismisses a request for a (6) The ALJ dismisses a hearing
hearing under any of the following request entirely or refuses to consider § 423.2100 Medicare appeals council
conditions: any one or more of the issues because review: general.
(1) At any time before notice of the an IRE, an ALJ or the MAC has made a (a) Consistent with § 423.1974, the
hearing decision is mailed, if the previous determination or decision enrollee may request that the MAC
enrollee asks to withdraw the request. under this subpart about the enrollee’s review an ALJ’s decision or dismissal.
This request may be submitted in rights on the same facts and on the same (b) When the MAC reviews an ALJ’s
writing to the ALJ or be made orally at issue(s), and this previous written decision, it undertakes a de
the hearing. The request for withdrawal determination or decision has become novo review.
must include a clear statement that the final by either administrative or judicial (c) The MAC issues a final action or
enrollee is withdrawing the request for action. remands a case no later than the end of
hearing and does not intend to further (7) The enrollee abandons the request the 90-day period beginning on the date
proceed with the appeal. If an attorney for hearing. An ALJ may conclude that the request for review is received (by the
or other legal professional on behalf of an enrollee has abandoned a request for entity specified in the ALJ’s written
an enrollee files the request for hearing when the ALJ hearing office notice of decision), unless the 90-day
withdrawal, the ALJ may presume that attempts to schedule a hearing and is period is extended as provided in this
the representative has advised the unable to contact the enrollee after subpart or the enrollee requests
enrollee of the consequences of the making reasonable efforts to do so. expedited MAC review.
withdrawal and dismissal. (8) Consistent with § 423.1972(c)(1), (d) If an enrollee requests expedited
(2) Neither the enrollee that requested the ALJ dismisses a hearing request if a MAC review, the MAC issues a final
the hearing nor the enrollee’s request clearly shows that the amount in action or remand as expeditiously as the
representative appears at the time and controversy is less than that required enrollee’s health condition requires, but
place set for the hearing, if— under § 423.1970. no later than the end of the 10-day
(i) The enrollee was notified before (b) Notice of dismissal. The ALJ mails period beginning on the date the request
the time set for the hearing that the a written notice of the dismissal of the for review is received (by the entity
request for hearing might be dismissed hearing request to the enrollee at his or specified in the ALJ’s written notice of
without further notice for failure to her last known address. The written decision), unless the 10-day period is
appear; or notice provides that there is a right to extended as provided in this subpart.
(ii) The enrollee did not appear at the request that the MAC vacate the
time and place of hearing and does not dismissal action. § 423.2102 Request for MAC review when
contact the ALJ hearing office within 10 (c) Consistent with § 423.1972(c)(2), ALJ issues decision or dismissal.
days for non-expedited hearings and 2 the ALJ discontinues a hearing and does (a)(1) An enrollee to the ALJ hearing
days for expedited hearings and provide not rule on the substantive issues raised may request a MAC review if the
good cause for not appearing; or in the appeal if, after a hearing is enrollee files a written request for a
(iii) The ALJ sends a notice to the initiated, the ALJ finds that the amount MAC review within 60 days after receipt
enrollee asking why the enrollee did not in controversy is less than the amount of the ALJ’s written decision or
appear; and the enrollee does not required under § 423.1970. dismissal.
(2) An enrollee may request that MAC ALJ’s action, the MAC sends written no later than the end of the 10-day
review be expedited if the appeal notice to the enrollee of the date of period beginning on the date the request
involves an issue specified in receipt of the request and for review is received by the entity
§ 423.566(b) but does not include solely commencement of the adjudication specified in the ALJ’s written notice of
a request for payment of Part D drugs timeframe. decision.
already furnished. (3) Denial of a request. If the MAC
(i) If an enrollee is requesting that the § 423.2108 MAC Actions when request for denies a request for expedited review,
review is filed.
MAC review be expedited, the enrollee the MAC must:
submits an oral or written request (a) General. Except as specified in (i) Make this decision within 5 days
within 60 days after the receipt of the paragraph (c) of this section, when an of receipt of the request for expedited
ALJ’s written decision or dismissal. A enrollee requests that the MAC review review;
prescribing physician may provide oral an ALJ’s decision, the MAC will review (ii) Give the enrollee and Part D plan
or written support for an enrollee’s the ALJ’s decision de novo. The enrollee sponsor within 5 days of receiving the
request for expedited review. requesting review does not have a right request written notice of the denial. The
(ii) The MAC must document all oral to a hearing before the MAC. The MAC written notice must inform the enrollee
requests for expedited review in writing will consider all of the evidence of the denial and explain that the MAC
and maintain the documentation in the admitted into the administrative record. will process the enrollee’s request using
case files. Upon completion of its review, the MAC the 90-day timeframe for non-expedited
(3) For purposes of this section, the may adopt, modify, or reverse the ALJ’s reviews.
date of receipt of the ALJ’s written decision or remand the case to the ALJ (4) A decision on a request for
decision or dismissal is presumed to be for further proceedings. Unless the expedited review may not be appealed.
5 days after the date of the notice of the MAC’s review is expedited as provided
decision or dismissal, unless there is in paragraph (d) of this section, the § 423.2110 MAC reviews on its own
MAC must issue its action no later than motion.
evidence to the contrary.
(4) The request is considered as filed 90 days after receiving the request for (a) General rule. The MAC may decide
on the date it is received by the entity review, unless the 90-day period has on its own motion to review a decision
specified in the notice of the ALJ’s been extended as provided in this or dismissal issued by an ALJ. CMS or
action. subpart. the IRE may refer a case to the MAC for
(b) An enrollee requesting a review (b) Review of ALJ’s dismissal. When it to consider reviewing under this
may ask that the time for filing a request an enrollee requests that the MAC authority any time within 60 days after
for MAC review be extended if— review an ALJ’s dismissal, the MAC the ALJ’s written decision or dismissal
(1) The request for an extension of may deny review or vacate the dismissal is issued.
time is in writing or, for expedited and remand the case to the ALJ for (b) Referral of cases. (1) CMS or the
reviews, in writing or oral. The MAC further proceedings. IRE may refer a case to the MAC if, in
must document all oral requests in (c) MAC dismissal of request for the view of CMS or the IRE, the decision
writing and maintain the documentation review. The MAC will dismiss a request or dismissal contains an error of law
in the case file. for review when the individual or entity material to the outcome of the claim or
(2) The request explains why the requesting review does not have a right presents a broad policy or procedural
request for review was not filed within to a review by the MAC, or will dismiss issue that may affect the public interest.
the stated time period. If the MAC finds the request for a hearing for any reason CMS or the IRE may also request that
that there is good cause for missing the that the ALJ could have dismissed the the MAC take own motion review of a
deadline, the time period will be request for hearing. case if—
extended. To determine whether good (d) Expedited reviews—(1) Standard (i) CMS or the IRE participated or
cause exists, the MAC uses the for expedited reviews. The MAC must requested to participate in the appeal at
standards outlined at § 405.942(b)(2) provide an expedited review if the the ALJ level; and
and § 405.942(b)(3). appeal involves an issue specified in (ii) In CMS’ or the IRE’s view, the
(c) An enrollee does not have the right § 423.566(b), but does not include solely ALJ’s decision or dismissal is not
to seek MAC review of an ALJ’s remand a request for payment of Part D drugs supported by the preponderance of
or an ALJ’s affirmation of an IRE’s already furnished, enrollee’s prescribing evidence in the record or the ALJ
dismissal of a request for physician indicates, or the MAC abused his or her discretion.
reconsideration. determines that applying the standard (2) CMS’ or the IRE’s referral to the
timeframe for making a decision may MAC is made in writing and must be
§ 423.2106 Where a request for review may seriously jeopardize the enrollee’s life or filed with the MAC no later than 60
be filed. health or ability to regain maximum days after the ALJ’s written decision or
When a request for a MAC review is function. The MAC may consider this dismissal is issued.
filed after an ALJ has issued a written standard as met if a lower level (i) The written referral will state the
decision or dismissal, the request for adjudicator has granted a request for an reasons why CMS or the IRE believes
review must be submitted to the entity expedited appeal. that the MAC should review the case on
specified in the notice of the ALJ’s (2) Grant of a Request. If the MAC its own motion.
action. If the request for review is timely grants a request for expedited review, (ii) CMS or the IRE will send a copy
filed with an entity other than the entity the MAC must: of its referral to the enrollee and to the
specified in the notice of the ALJ’s (i) Make this decision within 5 days ALJ.
action, the MAC’s adjudication period (iii) The enrollee may file exceptions
of receipt of the request for expedited

to conduct a review begins on the date review; to the referral by submitting written
the request for review is received by the (ii) Give the enrollee prompt oral comments to the MAC within 20 days
entity specified in the notice of the notice of this decision; and of the referral notice.
ALJ’s action. Upon receipt of a request (iii) Issue a decision, dismissal order (iv) An enrollee submitting comments
for review from an entity other than the or remand, as expeditiously as the to the MAC must send the comments to
entity specified in the notice of the enrollee’s health condition requires, but CMS or the IRE.
(c) Standard of review—(1) Referral by (4) A written request that is not made the tape of the oral proceedings.
CMS or the IRE when CMS or the IRE on a standard form or, for expedited However, the enrollee may be asked to
participated or requested to participate requests, an oral request, is accepted if pay the costs of providing these items.
in the ALJ level. If CMS or the IRE it includes the enrollee’s name and If an enrollee requests evidence from the
participated or requested to participate telephone number, the plan name; MAC and an opportunity to comment
in an appeal at the ALJ level, the MAC Medicare health insurance claim on that evidence, the time beginning
exercises its own motion authority if number; the ALJ appeal number; the with the MAC’s receipt of the request
there is an error of law material to the specific Part D drug(s) for which the for evidence through the expiration of
outcome of the case, an abuse of review is requested; a statement that the the time granted for the enrollee’s
discretion by the ALJ, the decision is enrollee is requesting an expedited response will not be counted toward the
not consistent with the preponderance review, if applicable; and the name and adjudication deadline.
of the evidence of record, or there is a signature of the enrollee or the
broad policy or procedural issue that representative of the enrollee. § 423.2120 Filing briefs with the MAC.
may affect the general public interest. In (b) The request for review must Upon request, the MAC will give the
deciding whether to accept review identify the parts of the ALJ action with enrollee requesting review a reasonable
under this standard, the MAC will limit which the enrollee requesting review opportunity to file a brief or other
its consideration of the ALJ’s action to disagrees and explain why he or she written statement about the facts and
those exceptions raised by CMS or the disagrees with the ALJ’s decision, law relevant to the case. Unless the
IRE. dismissal, or other determination being enrollee requesting review files the brief
(2) Referral by CMS or the IRE when appealed. or other statement with the request for
CMS or the IRE did not participate or (c) The MAC will limit its review of review, the time beginning with the date
request to participate in the ALJ an ALJ’s actions to those exceptions of receipt of the request to submit the
proceedings. The MAC will accept raised by the enrollee in the request for brief and ending with the date the brief
review if the decision or dismissal review, unless the enrollee is is received by the MAC will not be
contains an error of law material to the unrepresented. For purposes of this counted toward the adjudication
outcome of the case or presents a broad section only, a representative is either timeframe set forth in § 423.2100. The
policy or procedural issue that may anyone with a valid appointment as the MAC may also request, but not require,
affect the general public interest. In enrollee’s representative or is a member CMS, the IRE, and/or the Part D plan
deciding whether to accept review, the of the enrollee’s family, a legal guardian sponsor to file a brief or position paper
MAC will limit its consideration of the or an individual who routinely acts on if the MAC determines that it is
ALJ’s action to those exceptions raised behalf of the enrollee, such as a family necessary to resolve the issues in the
by CMS or the IRE. member or friend who has a power of case. The MAC cannot draw any adverse
(d) MAC’s action. (1) If the MAC attorney. inference if CMS, the IRE, and/or the
decides to review a decision or Part D plan sponsor either participates,
§ 423.2114 Dismissal of request for review. or decides not to participate in MAC
dismissal on its own motion, it will mail
the results of its action to the enrollee The MAC dismisses a request for review.
and to CMS or the IRE, as appropriate. review if the enrollee requesting review
§ 423.2122 What evidence may be
(2) The MAC may adopt, modify, or did not file the request within the stated submitted to the MAC.
reverse the decision or dismissal, may period of time and the time for filing has
(a) Appeal before the MAC on request
remand the case to an ALJ for further not been extended. The MAC also
for review of ALJ’s decision. (1) If the
proceedings or may dismiss a hearing dismisses the request for review if—
MAC is reviewing an ALJ’s decision, the
request. (a) The enrollee asks to withdraw the
MAC will consider the evidence
(3) The MAC must issue its action no request for review;
contained in the record of the
later than 90 days after receipt of the (b) The individual or entity does not
proceedings before the ALJ, and any
CMS or the IRE referral, unless the 90- have a right to request MAC review; or
new evidence that relates to the period
day period has been extended as (c) The enrollee died while the
before the coverage determination. If the
provided in this subpart. request for review is pending and the
hearing decision decides a new issue
(4) The MAC may not issue its action enrollee’s representative, if any, either
that the enrollee was not afforded an
before the 20-day comment period has has no remaining financial interest in
opportunity to address at the ALJ level,
expired, unless it determines that the the case or does not want to continue
the MAC considers any evidence related
agency’s referral does not provide a the appeal.
to that issue that is submitted with the
basis for reviewing the case. § 423.2116 Effect of dismissal of request request for review.
(5) If the MAC declines to review a for MAC review or request for hearing. (2) If the MAC determines that
decision or dismissal on its own motion, The dismissal of a request for MAC additional evidence is needed to resolve
the ALJ’s decision or dismissal remains review or denial of a request for review the issues in the case and the hearing
the final agency action in the case. of a dismissal issued by an ALJ is record indicates that the previous
binding and not subject to further decision-makers have not attempted to
§ 423.2112 Content of request for review. obtain the evidence, the MAC may
review unless reopened and vacated by
(a)(1) The request for MAC review the MAC. The MAC’s dismissal of a remand the case to an ALJ to obtain the
must be filed with the entity specified request for hearing is also binding and evidence and issue a new decision.
in the notice of the ALJ’s action. not subject to judicial review. (3) The MAC will not consider any
(2) The request for review must be in new evidence submitted regarding a
writing and may be made on a standard § 423.2118 Obtaining evidence from the change in condition of an enrollee after
form, except for requests for expedited MAC. a coverage determination is made. The
reviews which may be made orally. An enrollee may request and receive MAC will remand a case to the Part D
(3) The MAC must document all oral a copy of all or part of the record of the plan sponsor if the MAC determines
requests in writing and maintain the ALJ hearing, including the exhibits list, that the enrollee wishes to have
documentation in the case file. documentary evidence, and a copy of evidence on his or her change in
condition after the coverage § 423.2124 Oral argument. appeals. An enrollee may ask the MAC
determination considered. An enrollee may request to appear for additional time to file a brief or
(b) Subpoenas. When it is reasonably before the MAC to present oral written statement. The MAC will extend
necessary for the full presentation of a argument. this period, as appropriate, if the
case, the MAC may, on its own (a) The MAC grants a request for oral enrollee shows that he or she has good
initiative, issue subpoenas requiring an argument if it decides that the case cause for requesting the extension.
raises an important question of law, (ii) All other rules for filing briefs
enrollee or Part D plan sponsor to make
policy, or fact that cannot be readily with and obtaining evidence from the
books, records, correspondence, papers,
decided based on written submissions MAC follow the procedures explained
or other documents that are material to
alone. in this subpart.
an issue at the hearing available for (b) The MAC may decide on its own (5) Procedures before the MAC. (i) The
inspection and copying. that oral argument is necessary to MAC, after receiving a recommended
(1) To the extent a subpoena compels decide the issues in the case. If the MAC decision, will conduct proceedings and
disclosure of a matter for which an decides to hear oral argument, it informs issue its decision or dismissal according
objection based on privilege, or other the enrollee of the time and place of the to the procedures explained in this
protection from disclosure such as case oral argument at least 10 days before the subpart.
preparation, confidentiality or undue scheduled date or, in the case of an (ii) If the MAC determines that more
burden, was made before the MAC, the expedited review, at least 2 days before evidence is required, it may again
Secretary may review immediately that the scheduled date. remand the case to an ALJ for further
subpoena or a portion of the subpoena. (c) In case of a previously inquiry into the issues, rehearing,
(2) Upon notice to the MAC that an unrepresented enrollee, a newly hired receipt of evidence, and another
enrollee or Part D plan sponsor intends representative may request an extension decision or recommended decision.
to seek the Secretary review of the of time for preparation of the oral However, if the MAC decides that it can
subpoena, the MAC must stay all argument and the MAC must consider get the additional evidence more
proceedings affected by the subpoena, whether the extension is reasonable. quickly, it will take appropriate action.
(d) The MAC may also request, but (b) When the MAC must remand a
tolling the time period for the MAC to
not require, CMS, the IRE, and/or the case to the Part D plan sponsor. The
issue a final action or remand a case in
Part D plan sponsor to appear before it MAC will remand a case to the Part D
response to a request for review for 15
if the MAC determines that it may be plan sponsor if the MAC determines
days or until the Secretary makes a
helpful in resolving the issues in the that the enrollee wishes evidence on his
decision with respect to the review
case. or her change in condition after the
request, whichever occurs first. (e) The MAC cannot draw any adverse coverage determination to be considered
(3) If the Secretary does not grant inference if CMS, the IRE, and/or the in the appeal.
review within the time allotted for the Part D plan sponsor decide not to
stay, the stay is lifted and the subpoena participate in the oral argument. § 423.2128 Action of the MAC.
stands. (a) After it has reviewed all the
§ 423.2126 Case remanded by the MAC.
(c) Enforcement. (1) If the MAC evidence in the administrative record
(a) When the MAC may remand a case and any additional evidence received,
determines that an enrollee or other to the ALJ. (1) The MAC may remand a
person or entity subject to a subpoena subject to the limitations on MAC
case in which additional evidence is consideration of additional evidence in
issued under this section has refused to needed or additional action by the ALJ
comply with the subpoena, the MAC § 423.2122, the MAC will make a
is required. The MAC will designate in decision or remand the case to an ALJ.
may request the Secretary to seek its remand order whether the ALJ will
enforcement of the subpoena in (b) The MAC may adopt, modify, or
issue a final decision or a recommended reverse the ALJ hearing decision or
accordance with section 205(e) of the decision on remand.
Act, 42 U.S.C. 405(e). recommended decision.
(2) Action by ALJ on remand. The ALJ (c) The MAC mails a copy of its
(2) After submitting the enforcement will take any action that is ordered by decision to the enrollee at his or her last
request, the time period for the MAC to the MAC and may take any additional known address, to CMS, to the IRE, and
issue a final action or remand a case in action that is not inconsistent with the to the Part D plan sponsor.
response to a request for review is MAC’s remand order.
stayed for 15 days or until the Secretary (3) Notice when case is returned with § 423.2130 Effect of the MAC’s decision.
makes a decision with respect to the a recommended decision. When the ALJ The MAC’s decision is binding unless
enforcement request, whichever occurs sends a case to the MAC with a a Federal District Court issues a
first. recommended decision, a notice is decision modifying the MAC’s decision
mailed to the enrollee at his or her last or the decision is revised as the result
(3) Any enforcement request by the
known address. The notice tells the of a reopening in accordance with
MAC must consist of a written notice to
enrollee that the case was sent to the § 423.1980. An enrollee may file an
the Secretary describing in detail the
MAC, explains the rules for filing briefs action in a Federal District Court within
MAC’s findings of noncompliance and
or other written statements with the 60 days after the date the enrollee
its specific request for enforcement, and
MAC, and includes a copy of the receives written notice of the MAC’s
providing a copy of the subpoena and
recommended decision. decision.
evidence of its receipt by certified mail (4) Filing briefs with the MAC when
by the enrollee or other person or entity ALJ issues recommended decision. (i) § 423.2134 Extension of time to file action
subject to the subpoena. An enrollee may file with the MAC in Federal District Court.
(4) The MAC must promptly mail a briefs or other written statements about (a) An enrollee may request that the
copy of the notice and related the facts and law relevant to the case time for filing an action in a Federal
documents to the enrollee or other within 20 days of the date on the District Court be extended.
person or entity subject to the subpoena, recommended decision or with the (b) The request must—
and to any other affected person. request for review for expedited (1) Be in writing.
(2) Give the reasons why the action defendant and is granted 60 days from (i) The enrollee must file exceptions
was not filed within the stated time the date of receipt of the notice in which within 30 days of the date the enrollee
period. to commence the action against the receives the decision of the ALJ or
(3) Be filed with the MAC. correct defendant, the Secretary. submit a written request for an
(c) If the enrollee shows that he or she (e) Standard of review. (1) Under extension within the 30-day period.
had good cause for missing the section 205(g) of the Act, the findings of (ii) The MAC will grant a timely
deadline, the time period will be the Secretary of HHS as to any fact, if request for a 30-day extension. A
extended. To determine whether good supported by substantial evidence, are request for an extension of more than 30
cause exists, the MAC uses the conclusive. days must include a statement of
standards specified in § 405.942(b)(2) or (2) When the Secretary’s decision is reasons as to why the enrollee needs the
(b)(3) of this chapter. adverse to an enrollee due to an additional time and may be granted if
enrollee’s failure to submit proof in the MAC finds good cause under the
§ 423.2136 Judicial review. conformity with a regulation prescribed standard established in § 405.942(b)(2)
(a) General rule. To the extent under section 205(a) of the Act or (b)(3).
authorized by sections 1876(c)(5)(B) and pertaining to the type of proof an (3) If written exceptions are timely
1860D–4(h) of the Act and consistent enrollee must offer to establish filed, the MAC considers the enrollee’s
with § 423.1976, an enrollee may obtain entitlement to payment, the court will reasons for disagreeing with the
a court review of a MAC decision if the review only whether the proof conforms decision of the ALJ. If the MAC
amount in controversy meets the with the regulation and the validity of concludes that there is no reason to
threshold requirement estimated the regulation. change the decision of the ALJ, it will
annually by the Secretary. issue a notice addressing the exceptions
(b) Court in which to file civil action. § 423.2138 Case remanded by a Federal
District Court. and explaining why no change in the
(1) Consistent with § 423.1976(c), any
When a Federal District Court decision of the ALJ is warranted. In this
civil action described in paragraph (a) of
remands a case to the Secretary for instance, the decision of the ALJ is the
this section must be filed in the District
further consideration, unless the court final decision of the Secretary after
Court of the United States for the
order specifies otherwise, the MAC, remand.
judicial district in which the enrollee
acting on behalf of the Secretary, may (4) When an enrollee files written
resides.
(2) If the enrollee does not reside make a decision, or it may remand the exceptions to the decision of the ALJ,
within any judicial district, the civil case to an ALJ with instructions to take the MAC may assume jurisdiction at any
action must be filed in the District Court action and either issue a decision, take time. If the MAC assumes jurisdiction,
of the United States for the District of other action, or return the case to the it makes a new, independent decision
Columbia. MAC with a recommended decision. If based on its consideration of the entire
(c) Time for filing civil action. (1) Any the MAC remands a case, the record adopting, modifying, or reversing
civil action described in paragraph (a) of procedures specified in § 423.2140 will the decision of the ALJ or remanding the
this section must be filed within the be followed. case to an ALJ for further proceedings,
time periods specified in § 423.2130 or including a new decision. The new
§ 423.2140 MAC Review of ALJ decision in decision of the MAC is the final
§ 423.2134, as applicable. a case remanded by a Federal District
(2) For purposes of this section, the Court.
decision of the Secretary after remand.
date of receipt of the notice of the (c) MAC assumes jurisdiction without
(a) General rules. (1) In accordance
MAC’s decision shall be presumed to be exceptions being filed. (1) Any time
with § 423.2138, when a case is
5 days after the date of the notice, within 60 days after the date of the
remanded by a Federal District Court for
unless there is a reasonable showing to written decision of the ALJ, the MAC
further consideration and the MAC
the contrary. may decide to assume jurisdiction of the
remands the case to an ALJ, a decision
(3) Where a case is certified for case even though no written exceptions
subsequently issued by the ALJ becomes
judicial review in accordance with the the final decision of the Secretary unless have been filed.
expedited access to judicial review the MAC assumes jurisdiction. (2) Notice of this action is mailed to
process in § 423.1990, the civil action (2) The MAC may assume jurisdiction the enrollee at his or her last known
must be filed within 60 days after based on written exceptions to the address.
receipt of the review entity’s decision of the ALJ that an enrollee files (3) The enrollee will be provided with
certification, except where the time is with the MAC or based on its authority the opportunity to file a brief or other
extended by the ALJ or MAC, as under paragraph (c) of this section. written statement with the MAC about
applicable, upon a showing of good (3) The MAC either makes a new, the facts and law relevant to the case.
cause. independent decision based on the (4) After the brief or other written
(d) Proper defendant. (1) In any civil entire record that will be the final statement is received or the time
action described in paragraph (a) of this decision of the Secretary after remand, allowed (usually 30 days) for submitting
section, the Secretary of HHS, in his or or remands the case to an ALJ for further them has expired, the MAC will either
her official capacity, is the proper proceedings. issue a final decision of the Secretary
defendant. Any civil action properly (b) An enrollee files exceptions affirming, modifying, or reversing the
filed shall survive notwithstanding any disagreeing with the decision of the ALJ. decision of the ALJ, or remand the case
change of the person holding the Office (1) If an enrollee disagrees with an ALJ to an ALJ for further proceedings,
of the Secretary of HHS or any vacancy decision described in paragraph (a) of including a new decision.
in such office. this section, in whole or in part, he or (d) Exceptions are not filed and the
(2) If the complaint is erroneously she may file exceptions to the decision MAC does not otherwise assume
filed against the United States or against with the MAC. jurisdiction. If no exceptions are filed
any agency, officer, or employee of the (2) Exceptions may be filed by and the MAC does not assume
United States other than the Secretary, submitting a written statement to the jurisdiction over the case within 60 days
the plaintiff enrollee will be notified MAC setting forth the reasons for after the date of the ALJ’s written
that he or she has named an incorrect disagreeing with the decision of the ALJ. decision, the decision of the ALJ
becomes the final decision of the Dated: October 4, 2007.

Secretary after remand. Kerry Weems,
Authority: (Catalog of Federal Domestic Acting Administrator, Centers for Medicare
Assistance Program No. 93.778, Medical & Medicaid Services.
Assistance Program) (Catalog of Federal Constance B. Tobias,
Domestic Assistance Program No. 93.773, Chair, The Departmental Appeals Board.
Medicare—Hospital Insurance; and Program Perry Rhew,
No. 93.774, Medicare—Supplementary Chief Administrative Law Judge, Office of
Medical Insurance Program) Medicare Hearings and Appeals.
Approved: December 7, 2007.
Michael O. Leavitt,
Secretary.
Editorial Note: This document was
received at the Office of the Federal Register
on March 11, 2008.
[FR Doc. E8–5189 Filed 3–14–08; 8:45 am]
BILLING CODE 4120–01–P

Proposed Rule: Medicare Program Application of Certain Appeals Provisions To The Medicare Prescription Drug Appeals Process

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Proposed Rule: Medicare Program Application of Certain Appeals Provisions To The Medicare Prescription Drug Appeals Process

Uploaded by

Copyright:

Available Formats

Monday,

March 17, 2008

to pursue an appeal is likely to foster Privacy, Reporting and recordkeeping

request. determination or decision, even though date of the coverage determination or

of receipt of the request for expedited

becomes the final decision of the Dated: October 4, 2007.

You might also like