81 FR 53150 - Medicare Program; Administrative Law Judge Hearing Program for Medicare Claim and Entitlement Appeals; Quarterly Listing of Program Issuances-March Through June 2016
DEPARTMENT OF HEALTH AND HUMAN SERVICES Federal Register Volume 81, Issue 155 (August 11, 2016)
Federal Register Volume 81, Issue 155 (August 11, 2016)
| Page Range | 53150-53151 | |
| FR Document | 2016-18665 |
[Federal Register Volume 81, Number 155 (Thursday, August 11, 2016)] [Notices] [Pages 53150-53151] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-18665] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES [OMHA-1601-N] Medicare Program; Administrative Law Judge Hearing Program for Medicare Claim and Entitlement Appeals; Quarterly Listing of Program Issuances--March Through June 2016 AGENCY: Office of Medicare Hearings and Appeals (OMHA), HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: This quarterly notice lists the OMHA Case Processing Manual (OCPM) manual instructions that were published from March through June, 2016. 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 of 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. The fourth level of review is administered by the HHS Departmental Appeals Board (DAB) and conducted by the Medicare Appeals 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. As part of that effort, OMHA is establishing 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 we 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 occurred in the 3-month period. A hyperlink to the available chapters on the OMHA Web site is provided below. The OMHA Web site 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 Web site list 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 Web site 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 immediate notification of any updates to the OMHA Web site. This listserv avoids the need to check the OMHA Web site, as update notifications are sent to subscribers as they occur. If accessing the OMHA Web site proves to be [[Page 53151]] 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. We expect this notice to be used in concert with future published notices. The OCPM can be accessed at http://www.hhs.gov/omha/OMHA_Case_Processing_Manual/index.html. IV. OCPM Releases for March Through June 2016 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 Web site at http://www.hhs.gov/omha/OMHA_Case_Processing_Manual/index.html. OCPM Division II: Part A/B Claim Determinations Chapter 6, Pre-Hearing Case Development. This new chapter describes the pre-hearing case development process for requests for hearing on Medicare Part A and Part B reconsiderations issued by Qualified Independent Contractors (QICs) and Quality Improvement Organizations (QIOs), and escalations of requests for reconsideration by a QIC. The pre-hearing case development process helps identify and address evidentiary issues prior to the hearing to avoid delays and helps to ensure legal requirements related to new evidence are observed. The process also assists staff in determining whether a hearing is necessary for a given case. In addition, the process guides OMHA staff on processes available to facilitate the hearing process, such as identifying special needs for hearing participants, discovery, using experts, and conducting pre-hearing conferences. Dated: July 15, 2016. Jason M. Green, Chief Advisor, Office of Medicare Hearings and Appeals. [FR Doc. 2016-18665 Filed 8-10-16; 8:45 am] BILLING CODE 4152-01-P
![53150 Federal Register / Vol. 81, No. 155 / Thursday, August 11, 2016 / Notices
Devices (Infectious Disease NGS Dx staff direction for processing appeals at courts is available after administrative
devices). Specifically, FDA recommends the OMHA level of adjudication. remedies within SSA and HHS have
Infectious Disease NGS Dx devices that FOR FURTHER INFORMATION CONTACT: been exhausted.
employ targeted or agnostic Amanda Axeen, by telephone at (571) Sections 1869, 1155, 1876(c)(5)(B),
(metagenomics) sequencing to identify 777–2705, or by email at 1852(g)(5), and 1860D–4(h) of the Act
the presence or absence of infectious amanda.axeen@hhs.gov. are implemented through the
disease organisms, and/or detect the SUPPLEMENTARY INFORMATION: regulations at 42 CFR part 405 subparts
presence of absence of antimicrobial I and J; part 417, subpart Q; part 422,
resistance and virulence markers. I. Background subpart M; part 423, subparts M and U;
The Agency received requests for a The Office of Medicare Hearings and and part 478, subpart B. As noted above,
30-day extension of the comment period Appeals (OMHA), a staff division within OMHA administers the nationwide
for the document. Each request the Office of the Secretary of the U.S. Administrative Law Judge hearing
conveyed concern that the current 90- Department of Health and Human program in accordance with these
day comment period does not allow Services (HHS), administers the statutes and applicable regulations. As
sufficient time to develop a meaningful nationwide Administrative Law Judge part of that effort, OMHA is establishing
or thoughtful response to the document hearing program for Medicare claim, a manual, the OMHA Case Processing
on ‘‘Infectious Disease Next Generation organization and coverage Manual (OCPM). Through the OCPM,
Sequencing Based Diagnostic Devices: determination, and entitlement appeals the OMHA Chief Administrative Law
Microbial Identification and Detection under sections 1869, 1155, Judge establishes the day-to-day
of Antimicrobial Resistance and 1876(c)(5)(B), 1852(g)(5), and 1860D– procedures for carrying out adjudicative
Virulence Markers; Draft Guidance for 4(h) of the Social Security Act (the Act). functions, in accordance with
Industry and Food and Drug OMHA ensures that Medicare applicable statutes, regulations and
Administration Staff.’’ beneficiaries and the providers and OMHA directives. The OCPM provides
FDA has considered the request and suppliers that furnish items or services direction for processing appeals at the
is extending the comment period for the to Medicare beneficiaries, as well as OMHA level of adjudication for
document on ‘‘Infectious Disease Next Medicare Advantage Organizations Medicare Part A and B claims; Part C
Generation Sequencing Based (MAOs), Medicaid State Agencies, and organization determinations; Part D
Diagnostic Devices: Microbial applicable plans have a fair and coverage determinations; and SSA
Identification and Detection of impartial forum to address eligibility and entitlement, Part B late
Antimicrobial Resistance and Virulence disagreements with Medicare coverage enrollment penalty, and IRMAA
Markers; Draft Guidance for Industry and payment determinations made by determinations.
and Food and Drug Administration Medicare contractors, MAOs, or Part D Section 1871(c) of the Act requires
Staff’’ for 30 days, until September 10, Plan Sponsors (PDPSs), and that we publish a list of all Medicare
2016. The Agency believes that a 30-day determinations related to Medicare manual instructions, interpretive rules,
extension allows adequate time for eligibility and entitlement, Part B late statements of policy, and guidelines of
interested persons to submit comments enrollment penalty, and income-related general applicability not issued as
without significantly delaying monthly adjustment amounts (IRMAA) regulations at least every 3 months in
regulation on these important issues. made by the Social Security the Federal Register.
Dated: August 5, 2016. Administration (SSA).
II. Format for the Quarterly Issuance
Leslie Kux, The Medicare claim, organization and
Notices
Associate Commissioner for Policy. coverage determination appeals
[FR Doc. 2016–19109 Filed 8–10–16; 8:45 am]
processes consist of four levels of This quarterly notice provides the
administrative review, and a fifth level specific updates to the OCPM that have
BILLING CODE 4164–01–P
of review with the Federal district occurred in the 3-month period. A
courts after administrative remedies hyperlink to the available chapters on
DEPARTMENT OF HEALTH AND under HHS regulations have been the OMHA Web site is provided below.
HUMAN SERVICES exhausted. The first two levels of review The OMHA Web site contains the most
are administered by the Centers for current, up-to-date chapters and
[OMHA–1601–N] Medicare & Medicaid Services (CMS) revisions to chapters, and will be
and conducted by Medicare contractors available earlier than we publish our
Medicare Program; Administrative Law
for claim appeals, by MAOs and an quarterly notice. We believe the OMHA
Judge Hearing Program for Medicare
independent review entity for Part C Web site list provides more timely
Claim and Entitlement Appeals;
organization determination appeals, or access to the current OCPM chapters for
Quarterly Listing of Program
by PDPSs and an independent review those involved in the Medicare claim,
Issuances—March Through June 2016
entity for Part D coverage determination organization and coverage
AGENCY: Office of Medicare Hearings appeals. The third level of review is determination and entitlement appeals
and Appeals (OMHA), HHS. administered by OMHA and conducted processes. We also believe the Web site
ACTION: Notice. by Administrative Law Judges. The offers the public a more convenient tool
fourth level of review is administered by for real time access to current OCPM
SUMMARY: This quarterly notice lists the the HHS Departmental Appeals Board provisions. In addition, OMHA has a
OMHA Case Processing Manual (OCPM) (DAB) and conducted by the Medicare listserv to which the public can
sradovich on DSK3GMQ082PROD with NOTICES
manual instructions that were published Appeals Council. In addition, OMHA subscribe to receive immediate
from March through June, 2016. This and the DAB administer the second and notification of any updates to the
manual standardizes the day-to-day third levels of appeal, respectively, for OMHA Web site. This listserv avoids
procedures for carrying out adjudicative Medicare eligibility, entitlement, Part B the need to check the OMHA Web site,
functions, in accordance with late enrollment penalty, and IRMAA as update notifications are sent to
applicable statutes, regulations and reconsiderations made by SSA; a fourth subscribers as they occur. If accessing
OMHA directives, and gives OMHA level of review with the Federal district the OMHA Web site proves to be
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![Federal Register / Vol. 81, No. 155 / Thursday, August 11, 2016 / Notices 53151
difficult, the contact person listed above DEPARTMENT OF HEALTH AND The meeting will be closed to the
can provide the information. HUMAN SERVICES public in accordance with the
provisions set forth in sections
III. How To Use the Notice National Institutes of Health 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
This notice lists the OCPM chapters as amended. The contract proposals and
National Institute of Allergy and the discussions could disclose
and subjects published during the Infectious Diseases; Notice of Closed
quarter covered by the notice so the confidential trade secrets or commercial
Meeting property such as patentable material,
reader may determine whether any are
of particular interest. We expect this Pursuant to section 10(d) of the and personal information concerning
notice to be used in concert with future Federal Advisory Committee Act, as individuals associated with the contract
published notices. The OCPM can be amended (5 U.S.C. App.), notice is proposals, the disclosure of which
accessed at http://www.hhs.gov/omha/ hereby given of the following meeting. would constitute a clearly unwarranted
OMHA_Case_Processing_Manual/ The meeting will be closed to the invasion of personal privacy.
index.html. public in accordance with the Name of Committee: National Institute of
provisions set forth in sections Allergy and Infectious Diseases Special
IV. OCPM Releases for March Through 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Emphasis Panel; NIAID Peer Review Meeting.
June 2016 as amended. The grant applications and Date: September 7, 2016.
Time: 10:00 a.m. to 2:00 p.m.
The OCPM is used by OMHA the discussions could disclose
Agenda: To review and evaluate contract
adjudicators and staff to administer the confidential trade secrets or commercial proposals.
OMHA program. It offers day-to-day property such as patentable material, Place: National Institutes of Health, 3G61,
operating instructions, policies, and and personal information concerning 5601 Fishers Lane, Rockville, MD 20892
procedures based on statutes and individuals associated with the grant (Telephone Conference Call).
regulations, and OMHA directives. applications, the disclosure of which Contact Person: Travis J. Taylor, Ph.D.,
would constitute a clearly unwarranted Scientific Review Officer, Scientific Review
The following is a list and description invasion of personal privacy. Program, Division of Extramural Activities,
of new OCPM provisions and the Room 3G62B, 5601 Fishers Lane, MSC 9823,
subject matter. For future quarterly Name of Committee: National Institute of Bethesda, MD 20892–9823, (240) 669–5082,
Allergy and Infectious Diseases Special Travis.Taylor@nih.gov.
notices, we will list only the specific
Emphasis Panel NIAID SBIR Phase II Clinical
updates to the list of manual provisions (Catalogue of Federal Domestic Assistance
Trial Implementation Cooperative Agreement
that have occurred in the covered 3- Program Nos. 93.855, Allergy, Immunology,
(U44).
month period. This information is and Transplantation Research; 93.856,
Date: September 8, 2016.
available on our Web site at http:// Microbiology and Infectious Diseases
Time: 1:00 a.m. to 4:00 p.m.
Research, National Institutes of Health, HHS)
www.hhs.gov/omha/OMHA_Case_ Agenda: To review and evaluate grant
Processing_Manual/index.html. applications. Dated: August 4, 2016.
Place: National Institutes of Health Room Melanie J. Gray,
OCPM Division II: Part A/B Claim 3G31B, 5601 Fishers Lane, Rockville, MD Program Analyst, Office of Federal Advisory
Determinations 20892 (Telephone Conference Call). Committee Policy.
Contact Person: James T. Snyder, Ph.D.,
Chapter 6, Pre-Hearing Case [FR Doc. 2016–19046 Filed 8–10–16; 8:45 am]
Scientific Review Officer Scientific Review
Development. This new chapter Program, Division of Extramural Activities/ BILLING CODE 4140–01–P
describes the pre-hearing case Room 3G31B, National Institutes of Health,
development process for requests for NIAID, 5601 Fishers Lane MSC 9823,
hearing on Medicare Part A and Part B Rockville, MD 20892, (240) 669–5060, DEPARTMENT OF HEALTH AND
james.snyder@nih.gov. HUMAN SERVICES
reconsiderations issued by Qualified
Independent Contractors (QICs) and (Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology, National Institutes of Health
Quality Improvement Organizations
and Transplantation Research; 93.856,
(QIOs), and escalations of requests for Microbiology and Infectious Diseases National Institute of Dental &
reconsideration by a QIC. The pre- Research, National Institutes of Health, HHS) Craniofacial Research; Notice of
hearing case development process helps Closed Meeting
Dated: August 5, 2016.
identify and address evidentiary issues
prior to the hearing to avoid delays and Anna Snouffer, Pursuant to section 10(d) of the
helps to ensure legal requirements Deputy Director, Office of Federal Advisory Federal Advisory Committee Act, as
related to new evidence are observed. Committee Policy. amended (5 U.S.C. App.), notice is
The process also assists staff in [FR Doc. 2016–19045 Filed 8–10–16; 8:45 am] hereby given of the following meeting.
determining whether a hearing is BILLING CODE 4140–01–P The meeting will be closed to the
necessary for a given case. In addition, public in accordance with the
the process guides OMHA staff on provisions set forth in sections
processes available to facilitate the DEPARTMENT OF HEALTH AND 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
hearing process, such as identifying HUMAN SERVICES as amended. The grant applications and
special needs for hearing participants, the discussions could disclose
National Institutes of Health confidential trade secrets or commercial
discovery, using experts, and
property such as patentable material,
sradovich on DSK3GMQ082PROD with NOTICES
conducting pre-hearing conferences. National Institute of Allergy and and personal information concerning
Dated: July 15, 2016. Infectious Diseases; Notice of Closed individuals associated with the grant
Jason M. Green, Meeting applications, the disclosure of which
Chief Advisor, Office of Medicare Hearings Pursuant to section 10(d) of the would constitute a clearly unwarranted
and Appeals. Federal Advisory Committee Act, as invasion of personal privacy.
[FR Doc. 2016–18665 Filed 8–10–16; 8:45 am] amended (5 U.S.C. App.), notice is Name of Committee: National Institute of
BILLING CODE 4152–01–P hereby given of the following meeting. Dental and Craniofacial Research Special
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Document Created: 2018-02-09 11:27:10
Document Modified: 2018-02-09 11:27:10
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Contact | Amanda Axeen, by telephone at (571) 777-2705, or by email at [email protected] | |
| FR Citation | 81 FR 53150 |
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