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]

Download as PDF 38700 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Appeals; Quarterly Listing of Program Issuances—April Through June 2018 FDA is announcing the availability of a draft guidance for industry entitled ‘‘Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment.’’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 This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on endpoints for demonstrating effectiveness of drugs for medicationassisted treatment of opioid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 Electronic Access Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or https:// www.regulations.gov.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. daltland on DSKBBV9HB2PROD with NOTICES [FR Doc. 2018–16813 Filed 8–6–18; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 16:54 Aug 06, 2018 Jkt 244001 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 PO 00000 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 VerDate Sep<11>2014 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. PO 00000 Frm 00025 Fmt 4703 Sfmt 4703 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] BILLING CODE 4150–46–P 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: E:\FR\FM\07AUN1.SGM 07AUN1

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


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