Medicare Program; Administrative Law Judge Hearing Program for Medicare Claim and Entitlement Appeals; Quarterly Listing of Program Issuances-October Through December 2018, 763-764 [2019-00564]

Download as PDF Federal Register / Vol. 84, No. 21 / Thursday, January 31, 2019 / Notices XII. Effective Time Period VIII. Category of Disease, Health Condition, or Threat 42 U.S.C. 247d–6d(b)(2)(B) 42 U.S.C. 247d–6d(b)(2)(A) The category of disease, health condition, or threat for which I recommend the administration or use of the Covered Countermeasures is Ebola disease (EBOD). IX. Administration of Covered Countermeasures 42 U.S.C. 247d–6d(a)(2)(B) Administration of the Covered Countermeasure means physical provision of the countermeasures to recipients, or activities and decisions directly relating to public and private delivery, distribution and dispensing of the countermeasures to recipients, management and operation of countermeasure programs, or management and operation of locations for purpose of distributing and dispensing countermeasures. X. Population 42 U.S.C. 247d–6d(a)(4), 247d– 6d(b)(2)(C) The populations of individuals include any individual who uses or is administered the Covered Countermeasures in accordance with this Declaration. Liability immunity is afforded to manufacturers and distributors without regard to whether the countermeasure is used by or administered to this population; liability immunity is afforded to program planners and qualified persons when the countermeasure is used by or administered to this population, or the program planner or qualified person reasonably could have believed the recipient was in this population. XI. Geographic Area amozie on DSK3GDR082PROD with NOTICES1 42 U.S.C. 247d–6d(a)(4), 247d– 6d(b)(2)(D) Liability immunity is afforded for the administration or use of a Covered Countermeasure without geographic limitation. Liability immunity is afforded to manufacturers and distributors without regard to whether the countermeasure is used by or administered in any designated geographic area; liability immunity is afforded to program planners and qualified persons when the countermeasure is used by or administered in any designated geographic area, or the program planner or qualified person reasonably could have believed the recipient was in that geographic area. VerDate Sep<11>2014 20:21 Jan 30, 2019 Jkt 247001 Liability immunity for Covered Countermeasures began on February 27, 2015 and extends through December 31, 2023. 763 Dated: January 24, 2019. Alex M. Azar II, Secretary, Department of Health and Human Services. [FR Doc. 2019–00261 Filed 1–30–19; 8:45 am] BILLING CODE 4150–37–P XIII. Additional Time Period of Coverage DEPARTMENT OF HEALTH AND HUMAN SERVICES 42 U.S.C. 247d–6d(b)(3)(B) and (C) [OMHA–1803–N] I have determined that an additional 12 months of liability protection is reasonable to allow for the manufacturer(s) to arrange for disposition of the Covered Countermeasure, including return of the Covered Countermeasures to the manufacturer, and for Covered Persons to take such other actions as are appropriate to limit the administration or use of the Covered Countermeasures. Covered Countermeasures obtained for the Strategic National Stockpile (SNS) during the effective period of this Declaration are covered through the date of administration or use pursuant to a distribution or release from the SNS. Medicare Program; Administrative Law Judge Hearing Program for Medicare Claim and Entitlement Appeals; Quarterly Listing of Program Issuances—October Through December 2018 XIV. Countermeasures Injury Compensation Program 42 U.S.C 247d–6e The PREP Act authorizes the Countermeasures Injury Compensation Program (CICP) to provide benefits to certain individuals or estates of individuals who sustain a covered serious physical injury as the direct result of the administration or use of the Covered Countermeasures, and benefits to certain survivors of individuals who die as a direct result of the administration or use of the Covered Countermeasures. The causal connection between the countermeasure and the serious physical injury must be supported by compelling, reliable, valid, medical and scientific evidence in order for the individual to be considered for compensation. The CICP is administered by the Health Resources and Services Administration, within the Department of Health and Human Services. Information about the CICP is available at the toll-free number 1–855– 266–2427 (toll-free) or http:// www.hrsa.gov/cicp/. XV. Amendments 42 U.S.C. 247d–6d(b)(4) Any amendments to this Declaration will be published in the Federal Register. Authority: 42 U.S.C. 247d–6d. PO 00000 Frm 00118 Fmt 4703 Sfmt 4703 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 October through December 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: Jason Green, by telephone at (571) 777– 2723, or by email at jason.green@ hhs.gov. SUMMARY: 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 E:\FR\FM\31JAN1.SGM 31JAN1 amozie on DSK3GDR082PROD with NOTICES1 764 Federal Register / Vol. 84, No. 21 / Thursday, January 31, 2019 / Notices 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, VerDate Sep<11>2014 20:21 Jan 30, 2019 Jkt 247001 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 October through December 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, 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. 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. OCPM Releases for October Through December 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 OCPM provisions that were revised in the three-month period of October through December 2018. This information is available on our website at https://www.hhs.gov/about/agencies/ omha/the-appeals-process/caseprocessing-manual/index.html. OCPM Chapter 17: Dismissals Chapter 17, Dismissals. This chapter addresses the reasons an OMHA adjudicator may dismiss a request for PO 00000 Frm 00119 Fmt 4703 Sfmt 4703 hearing or a request for review of a CMS contractor’s dismissal of a request for a reconsideration, the contents of a dismissal order and its associated notice, and the effect of a dismissal. This chapter also addresses a party’s rights to appeal a dismissal and an adjudicator’s authority to vacate his or her own dismissal. OCPM Chapter 18: Requests for Information and Remands Chapter 18, Requests for Information and Remands. When authorized by the applicable regulations, OMHA adjudicators may use requests for information and remands to obtain information that is missing from an appeal, or request that a prior adjudicating entity take an action or issue a new appeal determination. In addition, an appellant and CMS or a CMS contractor in a Part A, B, or C appeal; an enrollee and CMS, the IRE, or a PDPS in a Part D appeal; or an appellant and SSA in an appeal of an SSA reconsideration may jointly request that a case be remanded to the prior adjudicator. This chapter describes the circumstances in which an OMHA adjudicator may issue a request for information or remand, and the requirements for requesting that an OMHA adjudicator remand a case. In addition, this chapter describes the right of a party, CMS, a CMS contractor, a PDPS, or SSA to request that the OMHA Chief Administrative Law Judge or a designee review a remand and, if it was not authorized by regulation, vacate the remand order. Dated: January 22, 2019. Jason M. Green, Chief Advisor, Office of Medicare Hearings and Appeals. [FR Doc. 2019–00564 Filed 1–30–19; 8:45 am] BILLING CODE 4150–46–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary Ebola Virus Disease Vaccines— Amendment Notice of Amendment to the December 3, 2014, Declaration under the Public Readiness and Emergency Preparedness Act for Ebola Virus Disease Vaccines, as amended. ACTION: The Secretary is amending the Declaration issued pursuant to the Public Health Service Act on December 3, 2014, as amended on December 1, 2015 and December 2, 2016, to update the term ‘‘Ebola Virus Disease’’ to SUMMARY: E:\FR\FM\31JAN1.SGM 31JAN1

Agencies

[Federal Register Volume 84, Number 21 (Thursday, January 31, 2019)]
[Notices]
[Pages 763-764]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-00564]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

[OMHA-1803-N]


Medicare Program; Administrative Law Judge Hearing Program for 
Medicare Claim and Entitlement Appeals; Quarterly Listing of Program 
Issuances--October Through December 2018

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 October through December 
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: Jason Green, by telephone at (571) 
777-2723, or by email at jason.green@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, 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

[[Page 764]]

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 October through 
December 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, 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. 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. OCPM Releases for October Through December 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 OCPM provisions that 
were revised in the three-month period of October through December 
2018. 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 17: Dismissals

    Chapter 17, Dismissals. This chapter addresses the reasons an OMHA 
adjudicator may dismiss a request for hearing or a request for review 
of a CMS contractor's dismissal of a request for a reconsideration, the 
contents of a dismissal order and its associated notice, and the effect 
of a dismissal. This chapter also addresses a party's rights to appeal 
a dismissal and an adjudicator's authority to vacate his or her own 
dismissal.

OCPM Chapter 18: Requests for Information and Remands

    Chapter 18, Requests for Information and Remands. When authorized 
by the applicable regulations, OMHA adjudicators may use requests for 
information and remands to obtain information that is missing from an 
appeal, or request that a prior adjudicating entity take an action or 
issue a new appeal determination. In addition, an appellant and CMS or 
a CMS contractor in a Part A, B, or C appeal; an enrollee and CMS, the 
IRE, or a PDPS in a Part D appeal; or an appellant and SSA in an appeal 
of an SSA reconsideration may jointly request that a case be remanded 
to the prior adjudicator. This chapter describes the circumstances in 
which an OMHA adjudicator may issue a request for information or 
remand, and the requirements for requesting that an OMHA adjudicator 
remand a case. In addition, this chapter describes the right of a 
party, CMS, a CMS contractor, a PDPS, or SSA to request that the OMHA 
Chief Administrative Law Judge or a designee review a remand and, if it 
was not authorized by regulation, vacate the remand order.

    Dated: January 22, 2019.
Jason M. Green,
Chief Advisor, Office of Medicare Hearings and Appeals.
[FR Doc. 2019-00564 Filed 1-30-19; 8:45 am]
 BILLING CODE 4150-46-P