[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