[Federal Register Volume 84, Number 147 (Wednesday, July 31, 2019)]
[Notices]
[Pages 37303-37304]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-16224]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-643 and CMS-10052]


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 August 30, 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

[[Page 37304]]

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 without 
change of a currently approved collection; Title of Information 
Collection: Hospice Survey and Deficiencies Report Form and Supporting 
Regulations; Use: We use the information collected as the basis for 
certification decisions for hospices that wish to obtain or retain 
participation in the Medicare and Medicaid programs. The information is 
used by CMS regional offices, which have the delegated authority to 
certify Medicare facilities for participation, and by State Medicaid 
agencies, which have comparable authority under Medicaid. The 
information on the Hospice Survey and Deficiencies Report Form is coded 
for entry into the OSCAR system. The data is analyzed by the CMS 
regional offices and by the CMS central office components for program 
evaluation and monitoring purposes. The information is also available 
to the public upon request. Form Number: CMS-643 (OMB control number: 
0938-0379); Frequency: Yearly; Affected Public: State, Local, or Tribal 
Governments; Number of Respondents: 4,801; Total Annual Responses: 
1,600; Total Annual Hours: 1,600. (For policy questions regarding this 
collection contact Thomas Pryor at 410-786-1132.)
    2. Type of Information Collection Request: Reinstatement with 
change of a previously approved collection; Title of Information 
Collection: Recognition of pass-through payment for additional (new) 
categories of devices under the Outpatient Prospective Payment System 
and Supporting Regulations; Use: Section 402 of the Benefits 
Improvement and Protection Act of 2000 (BIPA), enacted on December 21, 
2000, made changes in the provision for transitional pass-through 
payment for devices under the hospital OPPS. Section 402 of BIPA 
amended section 1833(t)(6) of the Act to require that we abandon the 
item-specific approach in determining the eligibility of medical 
devices for transitional pass-through payments. This provision mandated 
that we adopt a category approach for making such payments. In 
accordance with this requirement, we would pay for any device that 
falls in categories we establish for this purpose. This provision 
required us to establish the initial set of categories, to include 
devices previously determined eligible for transitional pass-through 
payments, effective April 1, 2001.
    The law made clear that application and approval processes are no 
longer required as the basis for determining an individual medical 
device's eligibility for transitional pass-through payments. However, 
we must assemble certain crucial information to be able to determine 
the appropriateness of establishing an additional (new) category. The 
information that we seek to collect is essential to determine whether 
additional categories of medical devices are appropriate for 
transitional pass-through payments. The intent of these provisions is 
to ensure that timely beneficiary access to new technologies is not 
jeopardized by inadequate payment levels.
    Interested parties such as hospitals, device manufacturers, 
pharmaceutical companies, and physicians apply for transitional pass-
through payment for certain items used with services covered in the 
outpatient PPS. After we receive all requested information, we evaluate 
the information to determine if the creation of an additional category 
of medical devices for transitional pass-through payments is justified. 
We may request additional information related to the proposed new 
device category, as needed. We advise the applicant of our decision, 
and update the outpatient PPS during its next scheduled quarterly 
payment update cycle to reflect any newly approved device categories. 
Form Number: CMS-10052 (OMB control number 0938-0857); Frequency: 
Occasionally; Affected Public: State, Local, and Tribal Governments; 
Number of Respondents: 10; Total Annual Responses: 10; Total Annual 
Hours: 160. (For policy questions regarding this collection contact 
AuSha Washington at 410-786-3736.)

    Dated: July 25, 2019.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2019-16224 Filed 7-30-19; 8:45 am]
BILLING CODE 4120-01-P