2019-16224. Agency Information Collection Activities: Submission for OMB Review; Comment Request  

  • Start Preamble

    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 Start Printed Page 37304Number: (202) 395-5806 OR, Email: OIRA_submission@omb.eop.gov.

    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 Paperwork@cms.hhs.gov.

    2. Call the Reports Clearance Office at (410) 786-1326.

    Start Further Info

    FOR FURTHER INFORMATION CONTACT:

    William Parham at (410) 786-4669.

    End Further Info End Preamble Start Supplemental Information

    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.)

    Start Signature

    Dated: July 25, 2019.

    William N. Parham, III,

    Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs.

    End Signature End Supplemental Information

    [FR Doc. 2019-16224 Filed 7-30-19; 8:45 am]

    BILLING CODE 4120-01-P

Document Information

Published:
07/31/2019
Department:
Centers for Medicare & Medicaid Services
Entry Type:
Notice
Action:
Notice.
Document Number:
2019-16224
Dates:
Comments on the collection(s) of information must be received by the OMB desk officer by August 30, 2019.
Pages:
37303-37304 (2 pages)
Docket Numbers:
Document Identifier: CMS-643 and CMS-10052
PDF File:
2019-16224.Pdf