[Federal Register Volume 85, Number 26 (Friday, February 7, 2020)]
[Notices]
[Pages 7306-7308]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-02357]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-3427, CMS-10709, CMS-10631 and CMS-10466]


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 March 9, 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

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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: Reinstatement with 
change of a previously approved collection; Title of Information 
Collection: End Stage Renal Disease Application and Survey and 
Certification Report; Use: Part I of this form is a facility 
identification and screening measurement used to initiate the 
certification and recertification of ESRD facilities. Part II is 
completed by the Medicare/Medicaid State survey agency to determine 
facility compliance with ESRD conditions for coverage. Form Number: 
CMS-3427 (OMB control number: 0938-0360); Frequency: Every three years; 
Affected Public: Private sector (Business or other for-profit and Not-
for profit institutions); Number of Respondents: 7,493; Total Annual 
Responses: 2,473; Total Annual Hours: 824. (For policy questions 
regarding this collection contact Jennifer Milby at 410-786-8828).
    2. 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: 1,338; Total 
Annual Responses: 1,338; Total Annual Hours: 64,224. (For policy 
questions regarding this collection contact Steven Johnson at 410-786-
3332.)
    3. Type of Information Collection Request: Revision with change of 
a currently approved collection; Title of Information Collection: The 
PACE Organization Application Process in 42 CFR part 460; Use: The 
Programs of All-Inclusive Care for the Elderly (PACE) consist of pre-
paid, capitated plans that provide comprehensive health care services 
to frail, older adults in the community who are eligible for nursing 
home care according to State standards. PACE organizations (PO) must 
provide all Medicare and Medicaid covered services; financing of this 
model is accomplished through prospective capitation of both Medicare 
and Medicaid payments. Upon approval of a PACE application, CMS 
executes a 3-way program agreement with the applicant entity and the 
applicable State Administering Agency (SAA). CMS regulations at 42 CFR 
460.98(b)(2) require a PO to provide PACE services in at least the PACE 
center, the home, and inpatient facilities. The PACE center is the 
focal point for the delivery of PACE services; the center is where the 
interdisciplinary team (IDT) is located, services are provided, and 
socialization occurs with staff that is consistent and familiar to 
participants.
    Collection of this information is mandated by statute under 
sections 1894(f) and 1934(f) of the Act and at 42 CFR part 460, subpart 
B, which addresses the PO application and waiver process. In general, 
PACE services are provided through a PO. An entity wishing to become a 
PO must submit an application to CMS that describes how the entity 
meets all the requirements in the PACE program. An entity's application 
must be accompanied by an assurance from the SAA of the State in which 
the PO is located.
    CMS recently issued a final PACE rule (CMS-4168-F), effective 
August 2, 2019, which updates and modernizes the PACE program. This 
final rule codifies CMS' existing practice of

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relying on automated review systems for processing initial applications 
to become a PACE organization and expansion applications for existing 
PACE organizations. In addition, the final rule will modify the PACE 
regulations to eliminate the need for PACE organizations to request 
waivers for a number of the most commonly waived provisions. This 
latter change is expected to reduce burden and improve efficiency for 
POs, state administering agencies, and CMS.
    In addition to codifying the current automated processes for the 
submission and review of both initial and service area expansion 
applications, this rule modifies existing regulatory provisions and 
requirements. As a result, certain attestations associated with the 
application are no longer applicable, and others need to be updated to 
reflect updated regulatory requirements. We are also making minor 
tweaks to certain document upload requirements for clarification 
purposes based on experience reviewing applications. Form Number: CMS-
10631 (OMB control number: 0938-1326); Frequency: Yearly; Affected 
Public: State, Local, or Tribal Governments; Number of Respondents: 72; 
Total Annual Responses: 109; Total Annual Hours: 7,226. (For policy 
questions regarding this collection contact Debbie Vanhoven at 410-786-
6625.)
    4. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Patient 
Protection and Affordable Care Act; Exchange Functions: Eligibility for 
Exemptions; Use: The data collection and reporting requirements in 
``Patient Protection and Affordable Care Act; Exchange Functions: 
Eligibility for Exemptions; Miscellaneous Minimum Essential Coverage 
Provisions'' (78 FR 39494--July 1, 2013)), address federal requirements 
that states must meet with regard to the Exchange minimum function of 
performing eligibility determinations and issuing certificates of 
exemption from the shared responsibility payment. In the final 
regulation, CMS addresses standards related to eligibility, including 
the verification and eligibility determination process, eligibility 
redeterminations, options for states to rely on HHS to make eligibility 
determinations for certificates of exemption, and reporting. Form 
Number: CMS-10466 (OMB control number: 0938-1190); Frequency: 
Occasionally; Affected Public: Private Sector (Businesses or other for-
profits); Number of Respondents: 45,060; Total Annual Responses: 
45,060; Total Annual Hours: 12,150. (For policy questions regarding 
this collection contact Katherine Bentley at 301-492-5209.)

    Dated: February 3, 2020.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2020-02357 Filed 2-5-20; 4:15 pm]
BILLING CODE 4120-01-P