DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for ...

1 [Billing Code: 4120-01-P] DEPARTMENT OF HEALTH AND HUMAN SERVICESC enters for Medicare & Medicaid Services42 CFR Part 414[CMS-1738-F, CMS-1687-F, and CMS-5531-F]RINs 0938-AU17, 0938-AT21, and 0938-AU32 Medicare Program; Durable Medical Equipment, Prosthetics, Orthotics, and supplies (DMEPOS) Policy Issues, and Level II of the Healthcare Common Procedure Coding System (HCPCS); DME Interim Pricing in the CARES Act; Durable Medical Equipment Fee Schedule Adjustments to Resume the Transitional 50/50 Blended Rates to Provide Relief in Rural Areas and Non-Contiguous AreasAGENCY: Centers for Medicare & Medicaid SERVICES (CMS), HEALTH and HUMAN SERVICES (HHS).

2 ACTION: Final : This final rule establishes methodologies for adjusting the Medicare durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) fee schedule amounts using information from the Medicare DMEPOS competitive bidding program (CBP) for items furnished on or after the effective date specified in the DATES section of this final rule, or the date immediately following the duration of the emergency period described in the Social Security Act (the Act), whichever is later. This final rule also establishes procedures for making benefit category and payment determinations for new items and SERVICES that are durable medical equipment (DME), prosthetic devices, orthotics and prosthetics, therapeutic shoes and inserts, surgical dressings, or splints, casts, and other devices used for reductions of fractures and dislocations under Medicare Part B.

3 In addition, this rule classifies continuous glucose monitors (CGMs) as DME under Medicare Part B. Lastly, this final rule finalizes certain DME fee This document is scheduled to be published in theFederal Register on 12/28/2021 and available online , and provisions that were included in two interim final rules with comment period (IFC) that CMS issued on May 11, 2018, and May 8, : These regulations are effective on [INSERT 60 DAYS AFTER THE DATE OF PUBLICATION WITH THE OFFICE OF THE FEDERAL REGISTER].FOR FURTHER INFORMATION CONTACT:Alexander Ullman, 410-786-9671 or INFORMATION:I.

4 Executive Summary A. PurposeThis final rule makes changes related to: the Durable Medical Equipment, Prosthetics, Orthotics, and supplies (DMEPOS) fee schedule amounts to ensure access to items and SERVICES in rural areas; procedures for making benefit category and payment determinations for new items and SERVICES that are DME, prosthetic devices, orthotics and prosthetics, therapeutic shoes and inserts, surgical dressings, or splints, casts, and other devices used for reductions of fractures and dislocations to prevent delays in coverage of new items and SERVICES ; and classification of CGMs under the Part B benefit for DME to establish the benefit category for these items.

5 Finally, we are finalizing provisions included in two interim final rules with comment period (IFC) that CMS issued on May 11, 2018, and May 8, 2020. 1. Durable Medical Equipment, Prosthetics, Orthotics, and supplies (DMEPOS) Fee Schedule Adjustments The purpose of this provision is to establish the methodologies for adjusting the fee schedule payment amounts for DMEPOS items and SERVICES furnished in non-competitive bidding areas (non-CBAs) on or after the effective date specified in the DATES section of this final rule, or the date immediately following the duration of the emergency period described in section 1135(g)(1)(B) of the Act (42 1320b 5(g)(1)(B))

6 , whichever is later. The emergency period we are referring to is the Public HEALTH Emergency (PHE) for coronavirus disease 2019 (COVID-19). We refer readers to section of this rule for details regarding the DMEPOS fee schedule changes CMS has already made as a result of the PHE for COVID-19. 2. DMEPOS Fee Schedule Adjustments for Items and SERVICES Furnished in Rural Areas from June 2018 through December 2018 and Exclusion of Infusion Drugs from the DMEPOS CBPThe purpose of this section is to finalize and address comments received on the May 11, 2018 IFC (83 FR 21912) titled Medicare Program; Durable Medical Equipment Fee Schedule Adjustments to Resume the Transitional 50/50 Blended Rates to Provide Relief in Rural Areas and Non-Contiguous Areas (hereinafter referred to as the May 2018 IFC ).

7 3. Benefit Category and Payment Determinations for DME, Prosthetic Devices, Orthotics and Prosthetics, Therapeutic Shoes and Inserts, Surgical Dressings, or Splints, Casts, and Other Devices Used for Reductions of Fractures and DislocationsThe purpose of this section of the final rule is to establish procedures for making benefit category and payment determinations for new items and SERVICES that are DME, prosthetic devices, orthotics and prosthetics, therapeutic shoes and inserts, surgical dressings, or splints, casts, and other devices used for reductions of fractures and dislocations that permit public consultation through public meetings.

8 Section 531(b) of the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA) (Pub. L. 106-554) requires the Secretary to establish procedures for coding and payment determinations for new DME under Part B of title XVIII of the Act that permit public consultation in a manner consistent with the procedures established for implementing coding modifications for ICD-9-CM (which has since been replaced with ICD-10-CM as of October 1, 2015). We decided to expand these procedures to address all new external HCPCS level II code requests in 2005.

9 We are finalizing procedures for making benefit category determinations and payment determinations for new items and SERVICES that are DME, prosthetic devices, orthotics and prosthetics, therapeutic shoes and inserts, surgical dressings, or splints, casts, and other devices used for reductions of fractures and dislocations. Consistent with our current practices, the procedures will incorporate public consultation on these determinations. The determination of whether or not an item or service falls under a Medicare benefit category, such as the Medicare Part B benefit category for DME, is a necessary step in determining whether an item may be covered under the Medicare program and, if applicable, what statutory and regulatory payment rules apply to the items and SERVICES .

10 If the item is excluded from coverage by the Act or does not fall within the scope of a defined benefit category, the item cannot be covered under Medicare. On the other hand, if the item is not excluded from coverage by the Act and is found to fall within a benefit category, we need to determine what payment rules would apply to the item if other statutory criteria for coverage of the item are met, such as the reasonable and necessary criteria under section 1862(a)(1)(A) of the Act. Therefore, the procedures that we are finalizing for use in determining if items and SERVICES fall under the Medicare Part B benefit categories for DME, prosthetic devices, orthotics, and prosthetics, surgical dressings, splints, casts and other devices for the reduction of fractures or dislocations, or therapeutic shoes and inserts continue our longstanding practice of establishing coverage and payment for new items and SERVICES soon after they are identified through the HCPCS code application process.