83 FR 38700 - Medicare Program; Administrative Law Judge Hearing Program for Medicare Claim and Entitlement Appeals; Quarterly Listing of Program Issuances-April Through June 2018
DEPARTMENT OF HEALTH AND HUMAN SERVICES Federal Register Volume 83, Issue 152 (August 7, 2018)
Federal Register Volume 83, Issue 152 (August 7, 2018)
| Page Range | 38700-38701 | |
| FR Document | 2018-16860 |
[Federal Register Volume 83, Number 152 (Tuesday, August 7, 2018)] [Notices] [Pages 38700-38701] From the Federal Register Online [www.thefederalregister.org] [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/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/index.html. 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/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-appeals-process/case-processing-manual/2017/index.html. 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/index.html. 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
![38700 Federal Register / Vol. 83, No. 152 / Tuesday, August 7, 2018 / Notices
Silver Spring, MD 20993–0002, 301– DEPARTMENT OF HEALTH AND of review with the Federal district
796–0963. HUMAN SERVICES courts after administrative remedies
under HHS regulations have been
SUPPLEMENTARY INFORMATION: [OMHA–1801–N] exhausted. The first two levels of review
I. Background Medicare Program; Administrative Law are administered by the Centers for
Judge Hearing Program for Medicare Medicare & Medicaid Services (CMS)
FDA is announcing the availability of and conducted by Medicare contractors
Claim and Entitlement Appeals;
a draft guidance for industry entitled for claim appeals, by MAOs and an
Quarterly Listing of Program
‘‘Opioid Use Disorder: Endpoints for independent review entity for Part C
Issuances—April Through June 2018
Demonstrating Effectiveness of Drugs for organization determination appeals, or
Medication-Assisted Treatment.’’ This AGENCY: Office of Medicare Hearings by PDPSs and an independent review
guidance addresses the clinical and Appeals (OMHA), HHS. entity for Part D coverage determination
endpoints acceptable to demonstrate ACTION: Notice. appeals. The third level of review is
effectiveness of drugs for medication- administered by OMHA and conducted
assisted treatment of opioid use SUMMARY: This quarterly notice by Administrative Law Judges and
disorder. FDA is also requesting announces the reorganization and attorney adjudicators. The fourth level
comments on when the use of placebo revision of the OMHA Case Processing of review is administered by the HHS
Manual (OCPM) and lists the OCPM Departmental Appeals Board (DAB) and
or active controls is most appropriate in
manual instructions that were published conducted by the Medicare Appeals
clinical trials for such drugs.
from April through June 2018. This Council (Council). In addition, OMHA
This draft guidance is being issued manual standardizes the day-to-day and the DAB administer the second and
consistent with FDA’s good guidance procedures for carrying out adjudicative third levels of appeal, respectively, for
practices regulation (21 CFR 10.115). functions, in accordance with Medicare eligibility, entitlement, Part B
The draft guidance, when finalized, will applicable statutes, regulations, and late enrollment penalty, and IRMAA
represent the current thinking of FDA OMHA directives, and gives OMHA reconsiderations made by SSA; a fourth
on endpoints for demonstrating staff direction for processing appeals at level of review with the Federal district
effectiveness of drugs for medication- the OMHA level of adjudication. courts is available after administrative
assisted treatment of opioid use FOR FURTHER INFORMATION CONTACT:
remedies within SSA and HHS have
disorder. It does not establish any rights Amanda Axeen, by telephone at (571) been exhausted.
for any person and is not binding on Sections 1869, 1155, 1876(c)(5)(B),
777–2705, or by email at
FDA or the public. You can use an 1852(g)(5), and 1860D–4(h) of the Act
amanda.axeen@hhs.gov.
are implemented through the
alternative approach if it satisfies the SUPPLEMENTARY INFORMATION: regulations at 42 CFR part 405 subparts
requirements of the applicable statutes I and J; part 417, subpart Q; part 422,
and regulations. This guidance is not I. Background
subpart M; part 423, subparts M and U;
subject to Executive Order 12866. The Office of Medicare Hearings and and part 478, subpart B. As noted above,
Appeals (OMHA), a staff division within OMHA administers the nationwide
II. Paperwork Reduction Act of 1995 the Office of the Secretary within the Administrative Law Judge hearing
This guidance refers to previously U.S. Department of Health and Human program in accordance with these
approved collections of information that Services (HHS), administers the statutes and applicable regulations. To
are subject to review by the Office of nationwide Administrative Law Judge ensure nationwide consistency in that
hearing program for Medicare claim, effort, OMHA established a manual, the
Management and Budget (OMB) under
organization and coverage OMHA Case Processing Manual
the Paperwork Reduction Act of 1995
determination, and entitlement appeals (OCPM). Through the OCPM, the
(44 U.S.C. 3501–3520). The collections
under sections 1869, 1155, OMHA Chief Administrative Law Judge
of information in 21 CFR part 312 have 1876(c)(5)(B), 1852(g)(5), and 1860D–
been approved under OMB control establishes the day-to-day procedures
4(h) of the Social Security Act (the Act). for carrying out adjudicative functions,
number 0910–0014. OMHA ensures that Medicare in accordance with applicable statutes,
III. Electronic Access beneficiaries and the providers and regulations and OMHA directives. The
suppliers that furnish items or services OCPM provides direction for processing
Persons with access to the internet to Medicare beneficiaries, as well as appeals at the OMHA level of
may obtain the draft guidance at either Medicare Advantage Organizations adjudication for Medicare Part A and B
https://www.fda.gov/Drugs/Guidance (MAOs), Medicaid State Agencies, and claims; Part C organization
ComplianceRegulatoryInformation/ applicable plans, have a fair and determinations; Part D coverage
Guidances/default.htm or https:// impartial forum to address determinations; and SSA eligibility and
www.regulations.gov. disagreements with Medicare coverage entitlement, Part B late enrollment
and payment determinations made by penalty, and IRMAA determinations.
Dated: August 1, 2018.
Medicare contractors, MAOs, or Part D Section 1871(c) of the Act requires
Leslie Kux, Plan Sponsors (PDPSs), and that the Secretary publish a list of all
Associate Commissioner for Policy. determinations related to Medicare Medicare manual instructions,
[FR Doc. 2018–16813 Filed 8–6–18; 8:45 am] eligibility and entitlement, Part B late interpretive rules, statements of policy,
BILLING CODE 4164–01–P enrollment penalty, and income-related and guidelines of general applicability
daltland on DSKBBV9HB2PROD with NOTICES
monthly adjustment amounts (IRMAA) not issued as regulations at least every
made by the Social Security 3 months in the Federal Register.
Administration (SSA).
The Medicare claim, organization and II. Format for the Quarterly Issuance
coverage determination appeals Notices
processes consist of four levels of This quarterly notice provides the
administrative review, and a fifth level specific updates to the OCPM that have
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![Federal Register / Vol. 83, No. 152 / Tuesday, August 7, 2018 / Notices 38701
occurred in the three-month period of January 17, 2017 Federal Register and Receipt of the disposition package also
April through June 2018. A hyperlink to became effective on March 20, 2017 (82 governs the timing for parties to file an
the available chapters on the OMHA FR 4974). New and revised chapters can appeal, and for the Council to initiate a
website is provided below. The OMHA be accessed at https://www.hhs.gov/ review of a case on its own motion. In
website contains the most current, up- about/agencies/omha/the-appeals- addition, the timely transfer of the
to-date chapters and revisions to process/case-processing-manual/ administrative record helps ensure
chapters, and will be available earlier index.html. Unless inconsistent with a effectuation can occur, SSA, CMS, or
than we publish our quarterly notice. statute, regulation, or other controlling CMS contractors can refer cases for
We believe the OMHA website provides authority, provisions of chapters that review by the Council, and the record
more timely access to the current OCPM were published before May 10, 2018, can be transitioned to storage. This
chapters for those involved in the remain in effect until revised, and can revised chapter describes the necessary
Medicare claim, organization and be accessed at: https://www.hhs.gov/ steps to timely and accurately close
coverage determination and entitlement about/agencies/omha/the-appeals- appeals pending at OMHA.
appeals processes. We also believe the process/case-processing-manual/2017/
website offers the public a more OCPM Chapter 20: Post-Adjudication
index.html.
convenient tool for real time access to Actions
current OCPM provisions. In addition, IV. OCPM Releases for April Through Chapter 20, Post-Adjudication
OMHA has a listserv to which the June 2018 Actions. This new chapter describes the
public can subscribe to receive The OCPM is used by OMHA various potential actions that may occur
notification of certain updates to the adjudicators and staff to administer the after an OMHA adjudicator issues a
OMHA website, including when new or OMHA program. It offers day-to-day decision, dismissal, or remand, and the
revised OCPM chapters are posted. If operating instructions, policies, and procedures for responding to such
accessing the OMHA website proves to procedures based on statutes and actions. These actions include requests
be difficult, the contact person listed regulations, and OMHA directives. to correct a clerical error, reopen a
above can provide the information. The following is a list and description decision, vacate a dismissal, or review
This notice lists the OCPM chapters of new OCPM provisions and the a remand issued by an OMHA
and subjects published during the subject matter. For future quarterly adjudicator. OMHA adjudicators take
quarter covered by the notice so the notices, we will list only the specific action to grant or deny such a request,
reader may determine whether any are updates to the list of manual provisions and in some instances may initiate an
of particular interest. We expect this that have occurred in the covered 3- action on their own motion.
notice to be used in concert with future month period. This information is In addition, parties may seek Council
published notices. The OCPM can be available on our website at https:// review of decisions and dismissals.
accessed at https://www.hhs.gov/about/ www.hhs.gov/about/agencies/omha/the- CMS and its contractors, or SSA, may
agencies/omha/the-appeals-process/ appeals-process/case-processing- also refer decisions and dismissals to
case-processing-manual/index.html. manual/index.html. the Council for possible own motion
III. How To Use the Notice OCPM Chapter 1: Manual Overview, review. The chapter also describes
Definition, and Governance actions the Council may take on an
This notice lists the OCPM chapters appealed or referred case, including
and subjects published during the Chapter 1, Manual Overview, remanding the case to OMHA.
quarter covered by the notice so the Definition, Governance. This chapter
reader may determine whether any are Dated: July 23, 2018.
describes the OCPM’s purpose and
of particular interest. We expect this organization. It also describes how to Amanda M. Axeen,
notice to be used in concert with future navigate the OCPM, and when and how Acting Chief Advisor, Office of Medicare
published notices. The OCPM can be to cite an OCPM provision as an Hearings and Appeals.
accessed at https://www.hhs.gov/about/ authority in an action issued by an [FR Doc. 2018–16860 Filed 8–6–18; 8:45 am]
agencies/omha/the-appeals-process/ OMHA adjudicator. BILLING CODE 4150–46–P
case-processing-manual/index.html. OMHA receives a variety of appeals,
as discussed in section I above. This
IV. Reorganization and Revision of the DEPARTMENT OF HEALTH AND
chapter describes when a specific
OCPM HUMAN SERVICES
OCPM provision may be read to apply
OMHA is in the process of to all or certain types of appeals, and
restructuring, reorganizing, and describes OCPM conventions for citing Office of the Secretary
reformatting the OCPM to make it more to statutory, regulatory, and other
user friendly. As part of this ongoing Declaration Under the Public
applicable authorities. In addition, this Readiness and Emergency
process, we are drafting new OCPM chapter describes the process for
chapters and revising existing OCPM Preparedness Act for Zika Virus
updating an OCPM chapter, as well as Vaccines
chapters to conform to the new format. how to determine when a revision was
Previously, the OCPM contained issued or became effective, and how to AGENCY: Department of Health and
separate divisions for each Medicare access prior versions of a chapter. Human Services.
part, and most chapters were repeated ACTION: Notice.
in each division. New and revised OCPM Chapter 19: Closing the Case
chapters provide information pertaining Chapter 19, Closing the Case. Timely SUMMARY: The Secretary is amending a
daltland on DSKBBV9HB2PROD with NOTICES
to all appeals arising under all Medicare notice of the disposition and closing of Declaration pursuant to the Public
parts. Plain language is used where a case, in compliance with applicable Health Service Act to provide liability
possible and guidance is provided in a laws and policy, is important to ensure immunity protection for activities
user-friendly, question-and-answer that effectuation of a decision, or other related to Zika virus vaccines consistent
format. The manual is also being revised necessary actions, can be undertaken by with the terms of the Declaration.
to reflect regulatory changes made by the parties to the appeal, CMS, CMS DATES: The declaration is effective as of
the final rule that was published in the contractors, plans, SSA, or the Council. August 1, 2018.
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Document Created: 2018-11-06 10:38:36
Document Modified: 2018-11-06 10:38:36
| 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 | 83 FR 38700 |
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