[Federal Register Volume 84, Number 220 (Thursday, November 14, 2019)]
[Notices]
[Page 61910]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-24756]



[[Page 61910]]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-367a-d and CMS-10400]


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

AGENCY: Centers for Medicare & Medicaid Services, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

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 December 16, 2019.

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 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: Revision of a currently 
approved collection; Title of Information Collection: Medicaid Drug 
Program; Use: Labelers transmit drug product and pricing data to CMS 
within 30 days after the end of each calendar month and quarter. CMS 
calculates the unit rebate amount (URA) and the unit rebate offset 
amount (UROA) for each new drug application (NDC) and distributes to 
all State Medicaid agencies. States use the URA to invoice the labeler 
for rebates and the UROA to report onto CMS-64. The monthly data is 
used to calculate Federal Upper Limit (FUL) prices for applicable drugs 
and for states that opt to use this data to establish their pharmacy 
reimbursement methodology. Form Number: CMS-367a, b, c, and d (OMB 
control number: 0938-0578); Frequency: Monthly, quarterly, and on 
occasion; Affected Public: Private sector (Business or other for-
profits); Number of Respondents: 743; Total Annual Responses: 14,117; 
Total Annual Hours: 219,185. (For policy questions regarding this 
collection contact Andrea Wellington at 410-786-3490.)
    2. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Establishment of 
Exchanges and Qualified Health Plans; Use: The Patient Protection and 
Affordable Care Act (Pub. L. 111-148) and the Health Care and Education 
Reconciliation Act of 2010 (Pub. L. 111-152) (collectively, the Patient 
Protection and Affordable Care Act (PPACA)) were signed into law in 
2010. The PPACA established competitive private health insurance 
markets, called Marketplaces or Exchanges, which give millions of 
Americans and small businesses access to qualified health plans (QHPs), 
including stand-alone dental plans (SADPs)--private health and dental 
insurance plans that are certified as meeting certain standards.
    As directed by the rule Establishment of Exchanges and Qualified 
Health Plans; Exchange Standards for Employers (77 FR 18310) (Exchange 
rule), each Exchange assumed responsibilities related to the 
certification and offering of QHPs. Under 45 CFR 156.280(e)(5)(ii), 
each QHP issuer that offers non-excepted abortion services must submit 
to the State Insurance Commissioner a segregation plan describing how 
the QHP issuer establishes and maintains separate payment accounts for 
any QHP covering non-excepted abortion services, and pursuant to Sec.  
156.280(e)(5)(iii), each QHP issuer must annually attest to compliance 
with PPACA section 1303 and applicable regulations. This segregation 
plan is used to verify that the QHP issuer's financial and other 
systems fully conform to the segregation requirements required by the 
PPACA. Form Number: CMS-10400 (OMB control number 0938-1156); 
Frequency: Annually; Affected Public: Private Sector (business or other 
for-profits, not-for-profit institutions); Number of Respondents: 210; 
Number of Responses: 210; Total Annual Hours: 580. For questions 
regarding this collection contact Michele Oshman at 410-786-4396.

    Dated: November 8, 2019.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2019-24756 Filed 11-13-19; 8:45 am]
 BILLING CODE 4120-01-P