[Federal Register Volume 85, Number 45 (Friday, March 6, 2020)]
[Notices]
[Pages 13163-13164]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-04607]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifiers: CMS-10718, CMS-304/-304a and CMS-368/-R-144]


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 April 6, 2020.

ADDRESSES: When commenting on the proposed information collections, 
please reference the document identifier or OMB control number. To be 
assured consideration, comments and recommendations must be received by 
the OMB desk officer via one of the following transmissions: OMB, 
Office of Information and Regulatory Affairs, Attention: CMS Desk 
Officer, Fax

[[Page 13164]]

Number: (202) 395-5806 OR, Email: [email protected].
    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: New collection; Title of 
Information Collection: Model Medicare Advantage and Medicare 
Prescription Drug Plan Individual Enrollment Request Form; Use: This 
information collection is necessary for the Medicare beneficiary (or 
their legal representative), to enroll in an MA or PDP plan, even if 
switching plans within the same MA or PDP organization. To consider an 
election complete, the individual must:
     Complete an enrollment request;
     Provide required information to the MA or PDP organization 
within the required time frames;
     Submit the completed request to the MA or PDP organization 
during a valid enrollment period.
     MA and PDP organizations, applicants to MA and PDP 
organizations, and the CMS will use the information collected to comply 
with the eligibility and enrollment requirements for Medicare Part C 
and Part D plans.
    Section 4001 of the Balanced Budget Act of 1997 (BBA) (Pub. L. 105-
33) enacted August 5, 1997, established Part C of the Medicare program, 
known as the Medicare + Choice program, (now referred to as Medicare 
Advantage (MA)). As required by 42 CFR 422.50(a)(5), an MA-eligible 
individual who meets the eligibility requirements for enrollment into 
an MA or MAPD plan may enroll during the enrollment periods specified 
in Sec.  422.62, by completing an enrollment form with the MA 
organization or enrolling through other mechanisms that CMS determines 
are appropriate.
    Section 101 of Title I of the Medicare Prescription Drug, 
Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173) 
enacted December 8, 2003, established Part D of the Medicare program, 
known as the Voluntary Prescription Drug Benefit Program. As required 
by 42 CFR 423.32(a) and (b), a Part D-eligible individual who wishes to 
enroll in a Medicare prescription drug plan (PDP) may enroll during the 
enrollment periods specified in Sec.  423.38, by completing an 
enrollment form with the PDP, or enrolling through other mechanisms CMS 
determines are appropriate. Form Number: CMS-10718 (OMB control number: 
0938-New); Frequency: Yearly; Affected Public: State, Local, or Tribal 
Governments; Number of Respondents: 14,749,256; Total Annual Responses: 
14,749,256; Total Annual Hours: 7,861,354. (For policy questions 
regarding this collection contact Deme Umo at (410) 786-8854.)
    2. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Reconciliation of 
State Invoice (ROSI) and Prior Quarter Adjustment Statement (PQAS); 
Use: Form CMS-304 (ROSI) is used by manufacturers to respond to the 
state's rebate invoice for current quarter utilization. Form CMS-304a 
(PQAS) is required only in those instances where a change to the 
original rebate data submittal is necessary. Form Number: CMS-304 and -
304a (OMB control number: 0938-0676); Frequency: Quarterly; Affected 
Public: Business or other for-profits; Number of Respondents: 1,255; 
Total Annual Responses: 5,020; Total Annual Hours: 227,416. (For policy 
questions regarding this collection contact Andrea Wellington at 410-
786-3490.)
    3. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Medicaid Drug 
Rebate State Reporting Program Forms; Use: We develop the rebate amount 
per drug unit from information supplied by the drug manufacturers and 
distributes these data to the states. States then must report quarterly 
to the drug manufacturers and report to us the total number of units of 
each dosage form/strength of their covered outpatient drugs reimbursed 
during a quarter and the rebate amount to be refunded. This report is 
due within 60 days of the end of each calendar quarter. The information 
in the report is based on claims paid by the state Medicaid agency 
during a calendar quarter. Form CMS-R-144 (Quarterly Report Data) is 
required from states quarterly to report utilization for any drugs paid 
for during that quarter. Form CMS-368 (Administrative Data) is required 
only in those instances where a change to the original data submittal 
is necessary. Form Number: CMS-368 and -R-144 (OMB control number: 
0938-0582); Frequency: Quarterly and on occasion; Affected Public: 
State, Local, or Tribal Governments; Number of Respondents: 56; Total 
Annual Responses: 234; Total Annual Hours: 12,101. (For policy 
questions regarding this collection contact Shannon Evans at 410-786-
3083.)

    Dated: March 3, 2020.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2020-04607 Filed 3-5-20; 8:45 am]
BILLING CODE 4120-01-P