38700 Federal Register / Vol. 83, No. 152 / Tuesday, August 7, 2018 / Notices 

Silver Spring, MD 20993–0002, 301– 

796–0963. 

SUPPLEMENTARY INFORMATION: 

I. Background 

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a draft guidance for industry entitled 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This draft guidance is being issued 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The draft guidance, when finalized, will 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may obtain the draft guidance at either 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. 

[FR Doc. 2018–16813 Filed 8–6–18; 8:45 am] 

BILLING CODE 4164–01–P 

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 

amanda.axeen@hhs.gov. 

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 


daltland on DSKBBV9HB2PROD with NOTICES
Federal Register / Vol. 83, No. 152 / Tuesday, August 7, 2018 / Notices 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, 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/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-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. 

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/theappeals-process/case-processingmanual/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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

Declaration Under the Public 

Readiness and Emergency 

Preparedness Act for Zika Virus 

Vaccines 

AGENCY: Department of Health and 

Human Services. 

ACTION: Notice. 

SUMMARY: 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. 


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