[Federal Register Volume 84, Number 189 (Monday, September 30, 2019)]
[Notices]
[Pages 51590-51591]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-21120]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10709]


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

[[Page 51591]]

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 November 29, 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-10709 Hospital Survey for Specified Covered Outpatient Drugs 
(SCODs)

    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 
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: New collection (Request 
for a new OMB control number); Title of Information Collection: 
Hospital Survey for Specified Covered Outpatient Drugs (SCODs); Use: In 
the CY 2018 OPPS/ASC payment system final rule with comment period, CMS 
finalized a policy to adjust payment for separately payable outpatient 
drugs acquired by eligible hospitals at discounted rates under HRSA's 
340B program from Average Sales Price (ASP) plus 6 percent to ASP minus 
22.5 percent. According to 42 U.S.C. 256b, eligible hospitals include 
those with a Medicare Disproportionate Share Hospital adjustment of 
greater than 11.75 percent, Children's Hospitals, Critical Access 
Hospitals, Cancer Hospitals, Rural Referral Centers and Sole Community 
Hospitals. The 340B program sets a ceiling on the price that covered 
entities pay for outpatient drugs. The 340B ceiling price refers to the 
maximum amount that a manufacturer can charge a covered entity for the 
purchase of a 340B covered outpatient drug. The 340B ceiling price is 
statutorily defined as the Average Manufacturer Price (AMP) reduced by 
the rebate percentage, which is commonly referred to as the Unit Rebate 
Amount (URA).
    On December 27, 2018, the United States District Court for the 
District of Columbia ruled that the Secretary of the Department of 
Health & Human Services exceeded his statutory authority to adjust 
payment rates under the Hospital Outpatient Prospective Payment System 
(OPPS) for separately payable, 340B-acquired drugs. See American 
Hospital Ass'n v. Azar, 348 F. Supp. 3d 62, 82-83 (D.D.C. 2018), appeal 
pending, Nos. 19-5048 & 19-5198 (D.C. Cir.). The Court reasoned, in 
part, that the Secretary had not collected the necessary data to set 
payment rates based on acquisition costs. The government disagrees with 
that ruling and has appealed. Nonetheless, in the event that the ruling 
is affirmed, CMS believes that it is important to begin obtaining 
acquisition costs for specified covered outpatient drugs to set payment 
rates based on cost for 340B-acquired drugs when they are furnished by 
certain covered entity hospitals.
    The acquisition cost data hospitals submit in response to this 
survey will be used to help determine payment amounts for drugs 
acquired under the 340B program. We want to ensure that the Medicare 
program pays for specified covered outpatient drugs purchased under the 
340B program at amounts that approximate what hospitals actually pay to 
acquire the drugs. This will ensure that the Medicare program uses 
taxpayer dollars prudently while maintaining beneficiary access to 
these drugs and allowing beneficiary cost-sharing to be based on the 
amounts hospitals actually pay to acquire the drugs. Form Number: CMS-
10709 (OMB control number: 0938-New); Frequency: Occasionally; Affected 
Public: Business or other for-profits and Not-for-profits, State, 
Local, or Tribal Governments; Number of Respondents: 761; Total Annual 
Responses: 46,610,448; Total Annual Hours: 33,484. (For policy 
questions regarding this collection contact Steven Johnson at 410-786-
3332.)

    Dated: September 25, 2019.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2019-21120 Filed 9-26-19; 4:15 pm]
BILLING CODE 4120-01-P