Medicare Program; Administrative Law Judge Hearing Program for Medicare Claim and Entitlement Appeals; Quarterly Listing of Program Issuances-April Through June 2018, 38700-38701 [2018-16860]
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Federal Register / Vol. 83, No. 152 / Tuesday, August 7, 2018 / Notices
Silver Spring, MD 20993–0002, 301–
796–0963.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
SUPPLEMENTARY INFORMATION:
[OMHA–1801–N]
I. Background
Medicare Program; Administrative Law
Judge Hearing Program for Medicare
Claim and Entitlement Appeals;
Quarterly Listing of Program
Issuances—April Through June 2018
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Opioid Use Disorder: Endpoints for
Demonstrating Effectiveness of Drugs for
Medication-Assisted Treatment.’’ This
guidance addresses the clinical
endpoints acceptable to demonstrate
effectiveness of drugs for medicationassisted treatment of opioid use
disorder. FDA is also requesting
comments on when the use of placebo
or active controls is most appropriate in
clinical trials for such drugs.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on endpoints for demonstrating
effectiveness of drugs for medicationassisted treatment of opioid use
disorder. It does not establish any rights
for any person and is not binding on
FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations. This guidance is not
subject to Executive Order 12866.
II. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information that
are subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR part 312 have
been approved under OMB control
number 0910–0014.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: August 1, 2018.
Leslie Kux,
Associate Commissioner for Policy.
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Office of Medicare Hearings
and Appeals (OMHA), HHS.
ACTION: Notice.
AGENCY:
This quarterly notice
announces the reorganization and
revision of the OMHA Case Processing
Manual (OCPM) and lists the OCPM
manual instructions that were published
from April through June 2018. This
manual standardizes the day-to-day
procedures for carrying out adjudicative
functions, in accordance with
applicable statutes, regulations, and
OMHA directives, and gives OMHA
staff direction for processing appeals at
the OMHA level of adjudication.
FOR FURTHER INFORMATION CONTACT:
Amanda Axeen, by telephone at (571)
777–2705, or by email at
amanda.axeen@hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
The Office of Medicare Hearings and
Appeals (OMHA), a staff division within
the Office of the Secretary within the
U.S. Department of Health and Human
Services (HHS), administers the
nationwide Administrative Law Judge
hearing program for Medicare claim,
organization and coverage
determination, and entitlement appeals
under sections 1869, 1155,
1876(c)(5)(B), 1852(g)(5), and 1860D–
4(h) of the Social Security Act (the Act).
OMHA ensures that Medicare
beneficiaries and the providers and
suppliers that furnish items or services
to Medicare beneficiaries, as well as
Medicare Advantage Organizations
(MAOs), Medicaid State Agencies, and
applicable plans, have a fair and
impartial forum to address
disagreements with Medicare coverage
and payment determinations made by
Medicare contractors, MAOs, or Part D
Plan Sponsors (PDPSs), and
determinations related to Medicare
eligibility and entitlement, Part B late
enrollment penalty, and income-related
monthly adjustment amounts (IRMAA)
made by the Social Security
Administration (SSA).
The Medicare claim, organization and
coverage determination appeals
processes consist of four levels of
administrative review, and a fifth level
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Frm 00024
Fmt 4703
Sfmt 4703
of review with the Federal district
courts after administrative remedies
under HHS regulations have been
exhausted. The first two levels of review
are administered by the Centers for
Medicare & Medicaid Services (CMS)
and conducted by Medicare contractors
for claim appeals, by MAOs and an
independent review entity for Part C
organization determination appeals, or
by PDPSs and an independent review
entity for Part D coverage determination
appeals. The third level of review is
administered by OMHA and conducted
by Administrative Law Judges and
attorney adjudicators. The fourth level
of review is administered by the HHS
Departmental Appeals Board (DAB) and
conducted by the Medicare Appeals
Council (Council). In addition, OMHA
and the DAB administer the second and
third levels of appeal, respectively, for
Medicare eligibility, entitlement, Part B
late enrollment penalty, and IRMAA
reconsiderations made by SSA; a fourth
level of review with the Federal district
courts is available after administrative
remedies within SSA and HHS have
been exhausted.
Sections 1869, 1155, 1876(c)(5)(B),
1852(g)(5), and 1860D–4(h) of the Act
are implemented through the
regulations at 42 CFR part 405 subparts
I and J; part 417, subpart Q; part 422,
subpart M; part 423, subparts M and U;
and part 478, subpart B. As noted above,
OMHA administers the nationwide
Administrative Law Judge hearing
program in accordance with these
statutes and applicable regulations. To
ensure nationwide consistency in that
effort, OMHA established a manual, the
OMHA Case Processing Manual
(OCPM). Through the OCPM, the
OMHA Chief Administrative Law Judge
establishes the day-to-day procedures
for carrying out adjudicative functions,
in accordance with applicable statutes,
regulations and OMHA directives. The
OCPM provides direction for processing
appeals at the OMHA level of
adjudication for Medicare Part A and B
claims; Part C organization
determinations; Part D coverage
determinations; and SSA eligibility and
entitlement, Part B late enrollment
penalty, and IRMAA determinations.
Section 1871(c) of the Act requires
that the Secretary publish a list of all
Medicare manual instructions,
interpretive rules, statements of policy,
and guidelines of general applicability
not issued as regulations at least every
3 months in the Federal Register.
II. Format for the Quarterly Issuance
Notices
This quarterly notice provides the
specific updates to the OCPM that have
E:\FR\FM\07AUN1.SGM
07AUN1
Federal Register / Vol. 83, No. 152 / Tuesday, August 7, 2018 / Notices
January 17, 2017 Federal Register and
became effective on March 20, 2017 (82
FR 4974). New and revised chapters can
be accessed at https://www.hhs.gov/
about/agencies/omha/the-appealsprocess/case-processing-manual/
index.html. Unless inconsistent with a
statute, regulation, or other controlling
authority, provisions of chapters that
were published before May 10, 2018,
remain in effect until revised, and can
be accessed at: https://www.hhs.gov/
about/agencies/omha/the-appealsprocess/case-processing-manual/2017/
index.html.
III. How To Use the Notice
This notice lists the OCPM chapters
and subjects published during the
quarter covered by the notice so the
reader may determine whether any are
of particular interest. We expect this
notice to be used in concert with future
published notices. The OCPM can be
accessed at https://www.hhs.gov/about/
agencies/omha/the-appeals-process/
case-processing-manual/.
daltland on DSKBBV9HB2PROD with NOTICES
occurred in the three-month period of
April through June 2018. A hyperlink to
the available chapters on the OMHA
website is provided below. The OMHA
website contains the most current, upto-date chapters and revisions to
chapters, and will be available earlier
than we publish our quarterly notice.
We believe the OMHA website provides
more timely access to the current OCPM
chapters for those involved in the
Medicare claim, organization and
coverage determination and entitlement
appeals processes. We also believe the
website offers the public a more
convenient tool for real time access to
current OCPM provisions. In addition,
OMHA has a listserv to which the
public can subscribe to receive
notification of certain updates to the
OMHA website, including when new or
revised OCPM chapters are posted. If
accessing the OMHA website proves to
be difficult, the contact person listed
above can provide the information.
This notice lists the OCPM chapters
and subjects published during the
quarter covered by the notice so the
reader may determine whether any are
of particular interest. We expect this
notice to be used in concert with future
published notices. The OCPM can be
accessed at https://www.hhs.gov/about/
agencies/omha/the-appeals-process/
case-processing-manual/.
OCPM Chapter 1: Manual Overview,
Definition, and Governance
Chapter 1, Manual Overview,
Definition, Governance. This chapter
describes the OCPM’s purpose and
organization. It also describes how to
navigate the OCPM, and when and how
to cite an OCPM provision as an
authority in an action issued by an
OMHA adjudicator.
OMHA receives a variety of appeals,
as discussed in section I above. This
chapter describes when a specific
OCPM provision may be read to apply
to all or certain types of appeals, and
describes OCPM conventions for citing
to statutory, regulatory, and other
applicable authorities. In addition, this
chapter describes the process for
updating an OCPM chapter, as well as
how to determine when a revision was
issued or became effective, and how to
access prior versions of a chapter.
IV. Reorganization and Revision of the
OCPM
OMHA is in the process of
restructuring, reorganizing, and
reformatting the OCPM to make it more
user friendly. As part of this ongoing
process, we are drafting new OCPM
chapters and revising existing OCPM
chapters to conform to the new format.
Previously, the OCPM contained
separate divisions for each Medicare
part, and most chapters were repeated
in each division. New and revised
chapters provide information pertaining
to all appeals arising under all Medicare
parts. Plain language is used where
possible and guidance is provided in a
user-friendly, question-and-answer
format. The manual is also being revised
to reflect regulatory changes made by
the final rule that was published in the
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16:54 Aug 06, 2018
Jkt 244001
IV. OCPM Releases for April Through
June 2018
The OCPM is used by OMHA
adjudicators and staff to administer the
OMHA program. It offers day-to-day
operating instructions, policies, and
procedures based on statutes and
regulations, and OMHA directives.
The following is a list and description
of new OCPM provisions and the
subject matter. For future quarterly
notices, we will list only the specific
updates to the list of manual provisions
that have occurred in the covered 3month period. This information is
available on our website at https://
www.hhs.gov/about/agencies/omha/theappeals-process/case-processingmanual/.
OCPM Chapter 19: Closing the Case
Chapter 19, Closing the Case. Timely
notice of the disposition and closing of
a case, in compliance with applicable
laws and policy, is important to ensure
that effectuation of a decision, or other
necessary actions, can be undertaken by
the parties to the appeal, CMS, CMS
contractors, plans, SSA, or the Council.
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38701
Receipt of the disposition package also
governs the timing for parties to file an
appeal, and for the Council to initiate a
review of a case on its own motion. In
addition, the timely transfer of the
administrative record helps ensure
effectuation can occur, SSA, CMS, or
CMS contractors can refer cases for
review by the Council, and the record
can be transitioned to storage. This
revised chapter describes the necessary
steps to timely and accurately close
appeals pending at OMHA.
OCPM Chapter 20: Post-Adjudication
Actions
Chapter 20, Post-Adjudication
Actions. This new chapter describes the
various potential actions that may occur
after an OMHA adjudicator issues a
decision, dismissal, or remand, and the
procedures for responding to such
actions. These actions include requests
to correct a clerical error, reopen a
decision, vacate a dismissal, or review
a remand issued by an OMHA
adjudicator. OMHA adjudicators take
action to grant or deny such a request,
and in some instances may initiate an
action on their own motion.
In addition, parties may seek Council
review of decisions and dismissals.
CMS and its contractors, or SSA, may
also refer decisions and dismissals to
the Council for possible own motion
review. The chapter also describes
actions the Council may take on an
appealed or referred case, including
remanding the case to OMHA.
Dated: July 23, 2018.
Amanda M. Axeen,
Acting Chief Advisor, Office of Medicare
Hearings and Appeals.
[FR Doc. 2018–16860 Filed 8–6–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Declaration Under the Public
Readiness and Emergency
Preparedness Act for Zika Virus
Vaccines
Department of Health and
Human Services.
ACTION: Notice.
AGENCY:
The Secretary is amending a
Declaration pursuant to the Public
Health Service Act to provide liability
immunity protection for activities
related to Zika virus vaccines consistent
with the terms of the Declaration.
DATES: The declaration is effective as of
August 1, 2018.
SUMMARY:
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]]>Agencies
[Federal Register Volume 83, Number 152 (Tuesday, August 7, 2018)]
[Notices]
[Pages 38700-38701]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-16860]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[OMHA-1801-N]
Medicare Program; Administrative Law Judge Hearing Program for
Medicare Claim and Entitlement Appeals; Quarterly Listing of Program
Issuances--April Through June 2018
AGENCY: Office of Medicare Hearings and Appeals (OMHA), HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This quarterly notice announces the reorganization and
revision of the OMHA Case Processing Manual (OCPM) and lists the OCPM
manual instructions that were published from April through June 2018.
This manual standardizes the day-to-day procedures for carrying out
adjudicative functions, in accordance with applicable statutes,
regulations, and OMHA directives, and gives OMHA staff direction for
processing appeals at the OMHA level of adjudication.
FOR FURTHER INFORMATION CONTACT: Amanda Axeen, by telephone at (571)
777-2705, or by email at [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
The Office of Medicare Hearings and Appeals (OMHA), a staff
division within the Office of the Secretary within the U.S. Department
of Health and Human Services (HHS), administers the nationwide
Administrative Law Judge hearing program for Medicare claim,
organization and coverage determination, and entitlement appeals under
sections 1869, 1155, 1876(c)(5)(B), 1852(g)(5), and 1860D-4(h) of the
Social Security Act (the Act). OMHA ensures that Medicare beneficiaries
and the providers and suppliers that furnish items or services to
Medicare beneficiaries, as well as Medicare Advantage Organizations
(MAOs), Medicaid State Agencies, and applicable plans, have a fair and
impartial forum to address disagreements with Medicare coverage and
payment determinations made by Medicare contractors, MAOs, or Part D
Plan Sponsors (PDPSs), and determinations related to Medicare
eligibility and entitlement, Part B late enrollment penalty, and
income-related monthly adjustment amounts (IRMAA) made by the Social
Security Administration (SSA).
The Medicare claim, organization and coverage determination appeals
processes consist of four levels of administrative review, and a fifth
level of review with the Federal district courts after administrative
remedies under HHS regulations have been exhausted. The first two
levels of review are administered by the Centers for Medicare &
Medicaid Services (CMS) and conducted by Medicare contractors for claim
appeals, by MAOs and an independent review entity for Part C
organization determination appeals, or by PDPSs and an independent
review entity for Part D coverage determination appeals. The third
level of review is administered by OMHA and conducted by Administrative
Law Judges and attorney adjudicators. The fourth level of review is
administered by the HHS Departmental Appeals Board (DAB) and conducted
by the Medicare Appeals Council (Council). In addition, OMHA and the
DAB administer the second and third levels of appeal, respectively, for
Medicare eligibility, entitlement, Part B late enrollment penalty, and
IRMAA reconsiderations made by SSA; a fourth level of review with the
Federal district courts is available after administrative remedies
within SSA and HHS have been exhausted.
Sections 1869, 1155, 1876(c)(5)(B), 1852(g)(5), and 1860D-4(h) of
the Act are implemented through the regulations at 42 CFR part 405
subparts I and J; part 417, subpart Q; part 422, subpart M; part 423,
subparts M and U; and part 478, subpart B. As noted above, OMHA
administers the nationwide Administrative Law Judge hearing program in
accordance with these statutes and applicable regulations. To ensure
nationwide consistency in that effort, OMHA established a manual, the
OMHA Case Processing Manual (OCPM). Through the OCPM, the OMHA Chief
Administrative Law Judge establishes the day-to-day procedures for
carrying out adjudicative functions, in accordance with applicable
statutes, regulations and OMHA directives. The OCPM provides direction
for processing appeals at the OMHA level of adjudication for Medicare
Part A and B claims; Part C organization determinations; Part D
coverage determinations; and SSA eligibility and entitlement, Part B
late enrollment penalty, and IRMAA determinations.
Section 1871(c) of the Act requires that the Secretary publish a
list of all Medicare manual instructions, interpretive rules,
statements of policy, and guidelines of general applicability not
issued as regulations at least every 3 months in the Federal Register.
II. Format for the Quarterly Issuance Notices
This quarterly notice provides the specific updates to the OCPM
that have
[[Page 38701]]
occurred in the three-month period of April through June 2018. A
hyperlink to the available chapters on the OMHA website is provided
below. The OMHA website contains the most current, up-to-date chapters
and revisions to chapters, and will be available earlier than we
publish our quarterly notice. We believe the OMHA website provides more
timely access to the current OCPM chapters for those involved in the
Medicare claim, organization and coverage determination and entitlement
appeals processes. We also believe the website offers the public a more
convenient tool for real time access to current OCPM provisions. In
addition, OMHA has a listserv to which the public can subscribe to
receive notification of certain updates to the OMHA website, including
when new or revised OCPM chapters are posted. If accessing the OMHA
website proves to be difficult, the contact person listed above can
provide the information.
This notice lists the OCPM chapters and subjects published during
the quarter covered by the notice so the reader may determine whether
any are of particular interest. We expect this notice to be used in
concert with future published notices. The OCPM can be accessed at
https://www.hhs.gov/about/agencies/omha/the-appeals-process/case-processing-manual/.
III. How To Use the Notice
This notice lists the OCPM chapters and subjects published during
the quarter covered by the notice so the reader may determine whether
any are of particular interest. We expect this notice to be used in
concert with future published notices. The OCPM can be accessed at
https://www.hhs.gov/about/agencies/omha/the-appeals-process/case-processing-manual/.
IV. Reorganization and Revision of the OCPM
OMHA is in the process of restructuring, reorganizing, and
reformatting the OCPM to make it more user friendly. As part of this
ongoing process, we are drafting new OCPM chapters and revising
existing OCPM chapters to conform to the new format. Previously, the
OCPM contained separate divisions for each Medicare part, and most
chapters were repeated in each division. New and revised chapters
provide information pertaining to all appeals arising under all
Medicare parts. Plain language is used where possible and guidance is
provided in a user-friendly, question-and-answer format. The manual is
also being revised to reflect regulatory changes made by the final rule
that was published in the January 17, 2017 Federal Register and became
effective on March 20, 2017 (82 FR 4974). New and revised chapters can
be accessed at https://www.hhs.gov/about/agencies/omha/the-appeals-process/case-processing-manual/. Unless inconsistent with a
statute, regulation, or other controlling authority, provisions of
chapters that were published before May 10, 2018, remain in effect
until revised, and can be accessed at: https://www.hhs.gov/about/agencies/omha/the-appeals-process/case-processing-manual/2017/.
IV. OCPM Releases for April Through June 2018
The OCPM is used by OMHA adjudicators and staff to administer the
OMHA program. It offers day-to-day operating instructions, policies,
and procedures based on statutes and regulations, and OMHA directives.
The following is a list and description of new OCPM provisions and
the subject matter. For future quarterly notices, we will list only the
specific updates to the list of manual provisions that have occurred in
the covered 3-month period. This information is available on our
website at https://www.hhs.gov/about/agencies/omha/the-appeals-process/case-processing-manual/.
OCPM Chapter 1: Manual Overview, Definition, and Governance
Chapter 1, Manual Overview, Definition, Governance. This chapter
describes the OCPM's purpose and organization. It also describes how to
navigate the OCPM, and when and how to cite an OCPM provision as an
authority in an action issued by an OMHA adjudicator.
OMHA receives a variety of appeals, as discussed in section I
above. This chapter describes when a specific OCPM provision may be
read to apply to all or certain types of appeals, and describes OCPM
conventions for citing to statutory, regulatory, and other applicable
authorities. In addition, this chapter describes the process for
updating an OCPM chapter, as well as how to determine when a revision
was issued or became effective, and how to access prior versions of a
chapter.
OCPM Chapter 19: Closing the Case
Chapter 19, Closing the Case. Timely notice of the disposition and
closing of a case, in compliance with applicable laws and policy, is
important to ensure that effectuation of a decision, or other necessary
actions, can be undertaken by the parties to the appeal, CMS, CMS
contractors, plans, SSA, or the Council. Receipt of the disposition
package also governs the timing for parties to file an appeal, and for
the Council to initiate a review of a case on its own motion. In
addition, the timely transfer of the administrative record helps ensure
effectuation can occur, SSA, CMS, or CMS contractors can refer cases
for review by the Council, and the record can be transitioned to
storage. This revised chapter describes the necessary steps to timely
and accurately close appeals pending at OMHA.
OCPM Chapter 20: Post-Adjudication Actions
Chapter 20, Post-Adjudication Actions. This new chapter describes
the various potential actions that may occur after an OMHA adjudicator
issues a decision, dismissal, or remand, and the procedures for
responding to such actions. These actions include requests to correct a
clerical error, reopen a decision, vacate a dismissal, or review a
remand issued by an OMHA adjudicator. OMHA adjudicators take action to
grant or deny such a request, and in some instances may initiate an
action on their own motion.
In addition, parties may seek Council review of decisions and
dismissals. CMS and its contractors, or SSA, may also refer decisions
and dismissals to the Council for possible own motion review. The
chapter also describes actions the Council may take on an appealed or
referred case, including remanding the case to OMHA.
Dated: July 23, 2018.
Amanda M. Axeen,
Acting Chief Advisor, Office of Medicare Hearings and Appeals.
[FR Doc. 2018-16860 Filed 8-6-18; 8:45 am]
BILLING CODE 4150-46-P
