Medicare Program; Administrative Law Judge Hearing Program for Medicare Claim and Entitlement Appeals; Quarterly Listing of Program Issuances-April Through June 2020, 58064-58065 [2020-20550]
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Federal Register / Vol. 85, No. 181 / Thursday, September 17, 2020 / Notices
https://www.fda.gov/drugs/drug-safetyand-availability/fda-requestswithdrawal-weight-loss-drug-belviqbelviq-xr-lorcaserin-market).
On February 13, 2020, Eisai requested
that FDA withdraw approval of NDA
022529 for BELVIQ and NDA 208524 for
BELVIQ XR under § 314.150(d) (21 CFR
314.150(d)), and waived its opportunity
for a hearing.
For the reasons discussed above, and
pursuant to the applicant’s request,
approval of NDA 022529 BELVIQ
(lorcaserin HCl) tablets and 208524
BELVIQ XR (lorcaserin HCl) extendedrelease tablets, and all amendments and
supplements thereto, are withdrawn
under § 314.150(d). Distribution of
BELVIQ into interstate commerce
without an approved application is
illegal and subject to regulatory action
(see sections 505(a) and 301(d) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355(a) and 331(d)).
Dated: September 11, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–20458 Filed 9–16–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[OMHA–2002–N]
Medicare Program; Administrative Law
Judge Hearing Program for Medicare
Claim and Entitlement Appeals;
Quarterly Listing of Program
Issuances—April Through June 2020
Office of Medicare Hearings
and Appeals (OMHA), HHS.
ACTION: Notice.
AGENCY:
This quarterly notice lists the
OMHA Case Processing Manual (OCPM)
instructions that were published from
April through June 2020. 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: Jon
Dorman, by telephone at (571) 457–
7220, or by email at jon.dorman@
hhs.gov.
SUPPLEMENTARY INFORMATION:
jbell on DSKJLSW7X2PROD with NOTICES
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
VerDate Sep<11>2014
17:37 Sep 16, 2020
Jkt 250001
nationwide Administrative Law Judge
hearing program for Medicare claim;
organization, coverage, and at-risk
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
determination, coverage determination,
and at-risk 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 (IRE) for
Part C organization determination
appeals, or by PDPSs and an IRE for Part
D coverage determination and at-risk
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
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
program in accordance with these
statutes and applicable regulations. To
help ensure nationwide consistency in
that effort, OMHA established a manual,
the 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 at-risk
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
three months in the Federal Register.
II. Format for the Quarterly Issuance
Notices
This quarterly notice provides the
specific updates to the OCPM that have
occurred in the three-month period of
April through June 2020. 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, coverage,
and at-risk 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.
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. The OCPM can be
accessed at https://www.hhs.gov/about/
agencies/omha/the-appeals-process/
case-processing-manual/.
E:\FR\FM\17SEN1.SGM
17SEN1
Federal Register / Vol. 85, No. 181 / Thursday, September 17, 2020 / Notices
IV. OCPM Releases for April Through
June 2020
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 OCPM provisions that were issued or
revised in the three-month period of
April through June 2020. This
information is available on our website
at https://www.hhs.gov/about/agencies/
omha/the-appeals-process/caseprocessing-manual/.
OCPM Chapter 2: Information
Disclosure
On June 17, 2020, OMHA issued
OCPM Chapter 2, which describes the
process used by OMHA staff when
addressing communications with parties
and non-parties, responding to inquiries
from the public and governmental
entities, safeguarding information in
accordance with applicable law, and,
when necessary, reporting unauthorized
disclosures of protected information.
The chapter explains how OMHA is
responsible for protecting personal, tax,
and health information in accordance
with the Social Security Act, the Privacy
Act, the Freedom of Information Act
(FOIA), the Internal Revenue Code, and
other applicable Federal statutes and
regulations, while also ensuring
information is provided upon request to
appropriate individuals or entities.
Karen W. Ames,
Executive Director, Office of Medicare
Hearings and Appeals.
[FR Doc. 2020–20550 Filed 9–16–20; 8:45 am]
BILLING CODE 4150–46–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
jbell on DSKJLSW7X2PROD with NOTICES
National Institute of Neurological
Disorders and Stroke; Notice of Closed
Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
VerDate Sep<11>2014
17:37 Sep 16, 2020
Jkt 250001
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Neurological Disorders and Stroke Special
Emphasis Panel NIH Support for Conferences
and Scientific Meetings (Parent R13 Clinical
Trial Not Allowed).
Date: October 21, 2020.
Time: 10:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, NSC
Building, 6001 Executive Boulevard,
Bethesda, MD 20892, (Virtual Meeting).
Contact Person: Bo-Shiun Chen, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, Division of Extramural Activities,
NINDS/NIH NSC, 6001 Executive Blvd.,
Suite 3208, MSC 9529, Bethesda, MD 20892,
(301) 496–9223, bo-shiun.chen@nih.gov.
Name of Committee: National Institute of
Neurological Disorders and Stroke Initial
Review Group Neurological Sciences and
Disorders B NSD–B.
Date: October 22–23, 2020.
Time: 9:00 a.m. to 12:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, NSC
Building, 6001 Executive Boulevard,
Bethesda, MD 20892, (Virtual Meeting).
Contact Person: Joel A Saydoff, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, Division of Extramural Activities,
NINDS/NIH NSC, 6001 Executive Blvd.,
Room 3205, MSC 9529, Bethesda, MD 20892,
(301)–496–9223, joel.saydoff@nih.gov.
Name of Committee: National Institute of
Neurological Disorders and Stroke Special
Emphasis Panel BRAIN Initiative Exploratory
Team Brain Circuit Programs U01 Review.
Date: October 23, 2020.
Time: 10:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, NSC
Building, 6001 Executive Boulevard,
Bethesda, MD 20892, (Virtual Meeting).
Contact Person: Li Jia, Ph.D., Scientific
Review Officer, Scientific Review Branch,
Division of Extramural Research, NINDS/
NIH, 6001 Executive Boulevard, Room
3208D, Rockville, MD 20852, 301 451–2854,
li.jia@nih.gov.
Name of Committee: Neurological Sciences
Training Initial Review Group NST–2
Subcommittee NINDS Post-doc Fellowships.
Date: November 9–11, 2020.
Time: 9:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, NSC
Building, 6001 Executive Boulevard,
Bethesda, MD 20892, (Virtual Meeting).
Contact Person: DeAnna Lynn Adkins,
Ph.D., Scientific Review Officer, Scientific
Review Branch, NSC Building Bethesda, MD
20892, 301–496–9223, deanna.adkins@
nih.gov.
Name of Committee: National Institute of
Neurological Disorders and Stroke Special
Emphasis Panel NINDS Institutional
Research Training Program T32.
Date: November 16–17, 2020.
PO 00000
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58065
Time: 9:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, NSC
Building, 6001 Executive Boulevard,
Bethesda, MD 20892, (Virtual Meeting).
Contact Person: Delany Torres, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, Division of Extramural Activities,
NINDS, Neuroscience Center Building (NSC),
6001 Executive Blvd., Suite 3208 Bethesda,
MD 20892, delany.torressalazar@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.853, Clinical Research
Related to Neurological Disorders; 93.854,
Biological Basis Research in the
Neurosciences, National Institutes of Health,
HHS)
Dated: September 11, 2020.
Tyeshia M. Roberson,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–20494 Filed 9–16–20; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; RFA–AI–20–001: Combating
Antibiotic-Resistant Bacteria (CARB)
Interdisciplinary Research Units (U19
Clinical Trial Not Allowed).
Date: October 14–16, 2020.
Time: 9:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3F21,
Rockville, MD 20892 (Virtual Meeting).
Contact Person: Annie Walker-Abbey,
Ph.D., Scientific Review Officer, Scientific
Review Program, Division of Extramural
Activities, National Institute of Allergy and
Infectious Diseases, National Institutes of
Health, 5601 Fishers Lane, Room 3F21,
E:\FR\FM\17SEN1.SGM
17SEN1
]]>Agencies
[Federal Register Volume 85, Number 181 (Thursday, September 17, 2020)]
[Notices]
[Pages 58064-58065]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-20550]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[OMHA-2002-N]
Medicare Program; Administrative Law Judge Hearing Program for
Medicare Claim and Entitlement Appeals; Quarterly Listing of Program
Issuances--April Through June 2020
AGENCY: Office of Medicare Hearings and Appeals (OMHA), HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This quarterly notice lists the OMHA Case Processing Manual
(OCPM) instructions that were published from April through June 2020.
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: Jon Dorman, by telephone at (571) 457-
7220, 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, coverage, and at-risk 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 determination, coverage
determination, and at-risk 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 (IRE) for Part C organization determination
appeals, or by PDPSs and an IRE for Part D coverage determination and
at-risk 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 help
ensure nationwide consistency in that effort, OMHA established a
manual, the 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 at-risk 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 three months in the Federal
Register.
II. Format for the Quarterly Issuance Notices
This quarterly notice provides the specific updates to the OCPM
that have occurred in the three-month period of April through June
2020. 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, coverage, and at-risk 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.
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. The OCPM can be accessed at https://www.hhs.gov/about/agencies/omha/the-appeals-process/case-processing-manual/.
[[Page 58065]]
IV. OCPM Releases for April Through June 2020
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 OCPM provisions that
were issued or revised in the three-month period of April through June
2020. This information is available on our website at https://www.hhs.gov/about/agencies/omha/the-appeals-process/case-processing-manual/.
OCPM Chapter 2: Information Disclosure
On June 17, 2020, OMHA issued OCPM Chapter 2, which describes the
process used by OMHA staff when addressing communications with parties
and non-parties, responding to inquiries from the public and
governmental entities, safeguarding information in accordance with
applicable law, and, when necessary, reporting unauthorized disclosures
of protected information. The chapter explains how OMHA is responsible
for protecting personal, tax, and health information in accordance with
the Social Security Act, the Privacy Act, the Freedom of Information
Act (FOIA), the Internal Revenue Code, and other applicable Federal
statutes and regulations, while also ensuring information is provided
upon request to appropriate individuals or entities.
Karen W. Ames,
Executive Director, Office of Medicare Hearings and Appeals.
[FR Doc. 2020-20550 Filed 9-16-20; 8:45 am]
BILLING CODE 4150-46-P
