Agency Information Collection Activities: Submission for OMB Review; Comment Request, 48255-48257 [2020-17417]

Agencies

• Centers for Medicare & Medicaid Services
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 85, Number 154 (Monday, August 10, 2020)]
[Notices]
[Pages 48255-48257]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-17417]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier CMS-10156, CMS-10170, CMS-10110 and CMS-10488]


Agency Information Collection Activities: Submission for OMB 
Review; Comment Request

AGENCY: Centers for Medicare & Medicaid Services, HHS.

ACTION: Notice.

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SUMMARY: The Centers for Medicare & Medicaid Services (CMS) is 
announcing an opportunity for the public to comment on CMS' intention 
to collect information from the public. Under the Paperwork Reduction 
Act of 1995 (PRA), federal agencies are required to publish notice in 
the Federal Register concerning each proposed collection of 
information, including each proposed extension or reinstatement of an 
existing collection of information, and to allow a second opportunity 
for public comment on the notice. Interested persons are invited to 
send comments regarding the burden estimate or any other aspect of this 
collection of information, including the necessity and utility of the 
proposed information collection for the proper performance of the 
agency's functions, the accuracy of the estimated burden, ways to 
enhance the quality, utility, and clarity of the information to be 
collected, and the use of automated collection techniques or other 
forms of information technology to minimize the information collection 
burden.

DATES: Comments on the collection(s) of information must be received by 
the OMB desk officer by September 9, 2020.

ADDRESSES: Written comments and recommendations for the proposed 
information collection should be sent within 30 days of publication of 
this notice to www.reginfo.gov/public/do/PRAMain . Find this particular

[[Page 48256]]

information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.
    To obtain copies of a supporting statement and any related forms 
for the proposed collection(s) summarized in this notice, you may make 
your request using one of following:
    1. Access CMS' website address at website address at https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html.
    1. Email your request, including your address, phone number, OMB 
number, and CMS document identifier, to [email protected].
    2. Call the Reports Clearance Office at (410) 786-1326.

FOR FURTHER INFORMATION CONTACT: William Parham at (410) 786-4669.

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from 
the Office of Management and Budget (OMB) for each collection of 
information they conduct or sponsor. The term ``collection of 
information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and 
includes agency requests or requirements that members of the public 
submit reports, keep records, or provide information to a third party. 
Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires 
federal agencies to publish a 30-day notice in the Federal Register 
concerning each proposed collection of information, including each 
proposed extension or reinstatement of an existing collection of 
information, before submitting the collection to OMB for approval. To 
comply with this requirement, CMS is publishing this notice that 
summarizes the following proposed collection(s) of information for 
public comment:
    1. Type of Information Collection Request: Reinstatement without 
change of a currently approved collection; Title of Information 
Collection: Retiree Drug Subsidy (RDS) Application and Instructions; 
Use: Under the Medicare Prescription Drug, Improvement, and 
Modernization Act of 2003 and implementing regulations at 42 CFR part 
423 subpart R plan sponsors (e.g., employers, unions) who offer 
prescription drug coverage to their qualified covered retirees are 
eligible to receive a 28% subsidy for allowable drug costs. In order to 
qualify, plan sponsors must submit a complete application to the 
Centers for Medicare & Medicaid Services (CMS) with a list of retirees 
for whom it intends to collect the subsidy. Once CMS reviews and 
analyzes the information on the application and the retiree list, 
notification will be sent to the plan sponsor about its eligibility to 
participate in the Retiree Drug Subsidy (RDS) Program.
    CMS has contracted with an outside vendor to assist in the 
administration of the RDS program; this effort is called the RDS 
Center. Plan Sponsors will apply on-line for the retiree drug subsidy 
by logging on to the RDS Secure website. 42 CFR 423.844 describes the 
requirement for qualified retiree prescription drug plans who want to 
receive the retiree drug subsidy. Once the Plan Sponsor submits the RDS 
application via the RDS Secure website (and a valid initial retiree 
list) CMS, through the use of its contractor, will analyze the 
application to determine whether the Plan Sponsor qualifies for the 
RDS. To qualify for the subsidy, the Plan Sponsor must show that its 
coverage is as generous as, or more generous than, the defined standard 
coverage under the Medicare Part D prescription drug benefit. Form 
Number: CMS-10156 (OMB control number: 0938-0957); Frequency: Yearly; 
Affected Public: Private Sector, Business or other for-profits, Not-
for-profits institutions; Number of Respondents: 1,803; Total Annual 
Responses: 1,803; Total Annual Hours: 115,392. (For policy questions 
regarding this collection contact Ivan Iveljic at 410-786-3312.)
    2. Type of Information Collection Request: Reinstatement without 
change of a currently approved collection; Title of Information 
Collection: Retiree Drug Subsidy Payment Request and Instructions; Use: 
Under the Medicare Prescription Drug, Improvement, and Modernization 
Act of 2003 and implementing regulations at 42 CFR part 423 subpart R 
plan sponsors (e.g., employers, unions) who offer prescription drug 
coverage to their qualified covered retirees are eligible to receive a 
28% subsidy for allowable drug costs. In order to qualify, plan 
sponsors must submit a complete application to the Centers for Medicare 
& Medicaid Services (CMS) with a list of retirees for whom it intends 
to collect the subsidy. Once CMS reviews and analyzes the information 
on the application and the retiree list, notification will be sent to 
the plan sponsor about its eligibility to participate in the Retiree 
Drug Subsidy (RDS) Program. Form Number: CMS-10170 (OMB control number: 
0938-0977); Frequency: Yearly; Affected Public: State, Local, or Tribal 
Governments; Number of Respondents: 1,803; Total Annual Responses: 
1,803; Total Annual Hours: 115,392. (For policy questions regarding 
this collection contact Ivan Iveljic at 410) 786-3312.)
    3. Type of Information Collection Request: Revision with change of 
a currently approved collection; Title of Information Collection: 
Manufacturer Submission of Average Sales Price (ASP) Data for Medicare 
Part B Drugs and Biologicals; Use: Section 1847A of the Act requires 
that the Medicare Part B payment amounts for covered drugs and 
biologicals not paid on a cost or prospective payment basis be based 
upon manufacturers' average sales price data submitted quarterly to the 
Centers for Medicare & Medicaid Services (CMS). The reporting 
requirements are specified in 42 CFR part 414 Subpart J.
    The Division of Ambulatory Services (DAS), will utilize the ASP 
data (ASP and number of units sold as specific in section 1847A of the 
Act) to determine the Medicare Part B drug payment amounts for CY 2005 
and beyond. The manufacturers submit their ASP data for all of their 
NDCs for Part B drugs. DAS compiles the data, analyzes the data and 
runs the data through software to calculate the volume-weighted ASP for 
all of the NDCs that are grouped within a given HCPCS code. The formula 
to calculate the volume-weighted ASP is the Sum (ASP * units) for all 
NDCs/Sum (units * bill units per pkg) for all NDCs. DAS provides ASP 
payment amounts for several components within CMS that utilize 1847(A) 
payment methodologies to implement various payment policies including, 
but not limited to, ESRD, OPPS, OTP and payment models. The Department 
of Health and Human Services' Office of the Inspector General also uses 
the ASP data in conducting statutorily mandated studies. Form Number: 
CMS-10110 (OMB control number: 0938-0921); Frequency: Quarterly; 
Affected Public: State, Local, or Tribal Governments; Number of 
Respondents: 300; Total Annual Responses: 1,200; Total Annual Hours: 
15,600. (For policy questions regarding this collection contact Felicia 
Eggleston at 410 786-9287.)
    4. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Consumer 
Experience Survey Data Collection; Use: Section 1311(c)(4) of the 
Affordable Care Act requires the Department of Health and Human 
Services (HHS) to develop an enrollee satisfaction survey system that 
assesses consumer experience with qualified health plans (QHPs) offered 
through an Exchange. It also requires public display of enrollee 
satisfaction information by the

[[Page 48257]]

Exchange to allow individuals to easily compare enrollee satisfaction 
levels between comparable plans. HHS established the QHP Enrollee 
Experience Survey (QHP Enrollee Survey) to assess consumer experience 
with the QHPs offered through the Marketplaces. The survey includes 
topics to assess consumer experience with the health care system such 
as communication skills of providers and ease of access to health care 
services. CMS developed the survey using the Consumer Assessment of 
Health Providers and Systems (CAHPS[supreg]) principles (https://www.ahrq.gov/cahps/about-cahps/principles/) and established 
an application and approval process for survey vendors who want to 
participate in collecting QHP enrollee experience data.
    The QHP Enrollee Survey, which is based on the CAHPS[supreg] Health 
Plan Survey, will be used to (1) help consumers choose among competing 
health plans, (2) provide actionable information that the QHPs can use 
to improve performance, (3) provide information that regulatory and 
accreditation organizations can use to regulate and accredit plans, and 
(4) provide a longitudinal database for consumer research. Based on the 
requirements for the QHP Enrollee Survey, CMS developed this survey to 
capture information about enrollees' experience with QHPs offered 
through an Exchange. CMS conducted in-depth formative research 
including: a comprehensive literature review, review of existing CMS 
survey instruments, consumer focus groups, stakeholder discussions, and 
input from a Technical Expert Panel (TEP). CMS performed a psychometric 
test and beta test in 2014 and 2015, respectively. CMS began fielding 
the QHP Enrollee Survey nationwide in 2016 and this request is to 
continue nationwide collection and administration of the statutorily-
required survey in 2021 through 2023. These activities are necessary to 
ensure that CMS fulfills legislative mandates established by section 
1311(c)(4) of the Affordable Care Act to develop an ``enrollee 
satisfaction survey system'' and provide such information on Exchange 
websites. Form Number: CMS-10488 (0938-1221): Frequency: Annually: 
Affected Public: Public sector (Individuals and Households), Private 
sector (Business or other for-profits and Not-for-profit institutions): 
Number of Respondents: 285; Total Annual Responses: 82,510; Total 
Annual Hours: 16,517. For policy questions regarding this collection 
contact Nidhi Singh Shah at 301-492-5110.

    Dated: August 5, 2020.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2020-17417 Filed 8-7-20; 8:45 am]
BILLING CODE 4120-01-P