[Federal Register Volume 84, Number 67 (Monday, April 8, 2019)]
[Notices]
[Pages 13929-13930]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06884]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier CMS-R-64 and CMS-10699]


Agency Information Collection Activities: Proposed Collection; 
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 (the 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 60 days for public 
comment on the proposed action. Interested persons are invited to send 
comments regarding our burden estimates 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 must be received by June 7, 2019.

ADDRESSES: When commenting, please reference the document identifier or 
OMB control number. To be assured consideration, comments and 
recommendations must be submitted in any one of the following ways:
    1. Electronically. You may send your comments electronically to 
http://www.regulations.gov. Follow the instructions for ``Comment or 
Submission'' or ``More Search Options'' to find the information 
collection document(s) that are accepting comments.
    2. By regular mail. You may mail written comments to the following 
address: CMS, Office of Strategic Operations and Regulatory Affairs, 
Division of Regulations Development, Attention: Document Identifier/OMB 
Control Number ___, Room C4-26-05, 7500 Security Boulevard, Baltimore, 
Maryland 21244-1850.
    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
    2. Email your request, including your address, phone number, OMB 
number, and CMS document identifier, to [email protected].
    3. Call the Reports Clearance Office at (410) 786-1326.

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

SUPPLEMENTARY INFORMATION:

Contents

    This notice sets out a summary of the use and burden associated 
with the following information collections. More detailed information 
can be found in each collection's supporting statement and associated 
materials (see ADDRESSES).

CMS-R-64 Indirect Medical Education and Direct Graduate Medical 
Education
CMS-10699 Information Collection Requirements Associated with Drug 
Pricing Transparency and Supporting Regulations in 42 CFR 403.1202

    Under the 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 requires federal agencies 
to publish a 60-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

[[Page 13930]]

submitting the collection to OMB for approval. To comply with this 
requirement, CMS is publishing this notice.

Information Collection

    1. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Indirect Medical 
Education and Direct Graduate Medical Education; Use: Section 
1886(d)(5)(B) of the Social Security Act requires additional payments 
to be made under the Medicare Prospective Payment System (PPS) for the 
indirect medical educational costs a hospital incurs in connection with 
interns and residents (IRs) in approved teaching programs. In addition, 
Title 42, Part 413, sections 75 through 83 implement section 1886(d) of 
the Act by establishing the methodology for Medicare payment for the 
costs of direct graduate medical educational activities. These 
payments, which are adjustments (add-ons) to other payments made to a 
hospital under PPS, are largely determined by the number of full-time 
equivalent (FTE) IRs that work at a hospital during its cost reporting 
period. In Federal fiscal year (FY) 2018, the estimated Medicare 
program payments for indirect medical education (IME) costs was $6.4 
billion. Medicare program payment for direct graduate medical education 
(GME) is also based upon the number of FTE-IRs that work at a hospital. 
In FY 2018, the estimated Medicare program payments for GME costs was 
$3.1 billion. Since it is important to accurately count the number of 
IRs FTEs working at each hospital, original approval was obtained from 
the Office of Management and Budget (OMB) in 1985 to collect the IR 
information required in 42 CFR 412.105(f) and timeframes for filing. 
All Medicare health plans are required to use these standardized 
notices. Form Number: CMS-R-64 (OMB control number: 0938-0456); 
Frequency: Yearly; Affected Public: Private Sector (Business or other 
for-profits, Not-for-profit institutions); Number of Respondents: 
1,245; Total Annual Responses: 1,245; Total Annual Hours: 2,490. (For 
policy questions regarding this collection contact Owen Osaghae at 410-
786-7550.)
    2. Type of Information Collection Request: New collection (Request 
for a new OMB control number); Title of Information Collection: 
Information Collection Requirements Associated with Drug Pricing 
Transparency and Supporting Regulations in 42 CFR 403.1202; Use: The 
Department of Health and Human Services proposed a rule (78 FR 52789) 
to revise the Federal Health Insurance Programs for the Aged and 
Disabled by amending regulations for the Medicare and Medicaid program, 
to require direct-to-consumer (DTC) television advertisements of 
prescription drugs and biological products for which payment is 
available through or under Medicare or Medicaid to include the 
Wholesale Acquisition Cost (WAC, or list price) of that drug or 
biological product. This rule is intended to improve the efficient 
administration of the Medicare and Medicaid programs by ensuring that 
beneficiaries are provided with relevant information about the costs of 
prescription drugs and biological products so they can make informed 
decisions that minimize not only their out-of-pocket costs, but also 
expenditures borne by Medicare and Medicaid, both of which are 
significant problems. It is necessary for manufacturers to display the 
list price in direct-to-consumer television advertisements of 
prescription drugs and biological products to provide relevant 
information to beneficiaries to allow them to work with their 
prescribers to select the best overall treatment. Form Number: CMS-
10699 (OMB control number: 0938-New); Frequency: Occasionally; Affected 
Public: Private Sector (Business or other for-profits); Number of 
Respondents: 25; Total Annual Responses: 1,200; Total Annual Hours: 
300. (For policy questions regarding this collection contact Cheri Rice 
at 410 786-6499.)

    Dated: April 3, 2019.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2019-06884 Filed 4-5-19; 8:45 am]
 BILLING CODE 4120-01-P