Agency Information Collection Activities: Proposed Collection; Comment Request

AGENCY:

Centers for Medicare & Medicaid Services, Health and Human 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 (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 February 14, 2022.

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 .

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-10524 Medicare Program; Prior Authorization Process for Certain Durable Medical Equipment, Prosthetic, Orthotics, and Supplies (DMEPOS)

CMS-906 Fiscal Soundness Reporting Requirements (FSRR)

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: Extension of a currently approved collection; Title of Information Collection: Medicare Program; Prior Authorization Process for Certain Durable Medical Equipment, Prosthetic, Orthotics, and Supplies (DMEPOS); Use: Section 1834(a)(15) of the Social Security Act (the Act) authorizes the Secretary to develop and periodically update a list of DMEPOS that the Secretary determines, on the basis of prior payment experience, are frequently subject to unnecessary utilization and to develop a prior authorization process for these items. Pursuant to this authority, CMS published final rules CMS-6050-F and CMS-1713-F.

The information required under this collection is used to determine proper payment and coverage for DMEPOS items. The information requested includes all documents and information that demonstrate the DMEPOS item requested is reasonable and necessary for the beneficiary and meets applicable Medicare requirements. The documentation will be reviewed by trained registered nurses, therapists, or physician reviewers to determine if item(s) or service requested meets all applicable Medicare coverage, coding and payment rules. Form Number: CMS-10524 (OMB control number: 0938-1293); Frequency: Occasionally; Affected Public: Private Sector (Business or other for-profits, Not-for-Profit Institutions); Number of Respondents: 273,305; Total Annual Responses: 273,305; Total Annual Hours: 136,652. (For policy questions regarding this collection contact Stephanie Collins at (410) 786-0959.)

2. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Fiscal Soundness Reporting Requirements (FSRR); Use: Title 18 Section 1857(d)(4)(A)(i) requires that contracting organizations such as Medicare Health Plans (including Medicare Advantage (MA) organizations, Medicare-Medicaid Capitated Financial Alignment Demonstrations (MMPs)) and 1876 Cost Plans), Prescription Drug Plan sponsors (PDPs), and Programs of All-Inclusive Care for the Elderly (PACE) organizations report financial information demonstrating the organization has a fiscally sound operation. The FSRR is designed to capture financial data of these contracting entities. The Division of Finance and Benefits (DFB) within the Medicare Advantage Contract Administration Group (MCAG) of CMS is assigned the responsibility of reviewing ongoing financial performance of the contracting entities.

All contracting organizations must submit audited annual financial statements one time per year. In addition to the audited annual submission, Health Plans with a negative net worth and/or a net loss and the amount of that loss is greater than one-half of the organization's total net worth submit quarterly financial statements for fiscal soundness monitoring. Part D organizations are required to submit three (3) quarterly financial statements. Lastly, PACE organizations are required to file four (4) quarterly financial statements for the first three (3) years in the program. After the first three (3) years, PACE organizations with a negative net worth and/or a net loss and the amount of that loss is greater than one-half of the organization's total net worth must submit quarterly financial statements for fiscal soundness monitoring. Form Number: CMS-906 (OMB control number: 0938-0496); Frequency: Quarterly and Yearly; Affected Public: Private Sector (Business or other for-profits, Not-for-Profit Institutions); Number of Respondents: 936; Total Annual Responses: 1,958; Total Annual Hours: 652. (For policy questions regarding this collection contact Christa M. Zalewski at (410) 786-1971.)