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HHS/CMS RIN: 0938-AU17 Publication ID: Fall 2021 
Title: Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Policy Issues and Level II of the Healthcare Common Procedure Coding System (HCPCS) (CMS-1738)(Section 610 Review) 
Abstract:

This final rule responds to public comments on the proposed rule that published November 4, 2020, and establishes regulations for policy and program issues. Among the issues under consideration for this final rule are methodologies for adjusting the Medicare DMEPOS fee schedule amounts using information from the Medicare DMEPOS competitive bidding program for items furnished on the date immediately following the duration of the emergency period described in section 1135(g)(1)(B) of the Social Security Act; establishing 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; classifying continuous glucose monitors (CGMs) as DME under Medicare Part B and establishing fee schedule amounts for these items and related supplies and accessories; and other issues in the proposed rule and interim final rules with comment period (IFC) that CMS issued on May 11, 2018 and May 8, 2020.

 
Agency: Department of Health and Human Services(HHS)  Priority: Economically Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Long-Term Actions 
Major: Yes  Unfunded Mandates: No 
RFA Section 610 Review: Section 610 Review 
CFR Citation: 42 CFR 414   
Legal Authority: 42 U.S.C. 1395l    42 U.S.C. 1395m    42 U.S.C. 1395u    42 U.S.C. 1395w-3   
Legal Deadline:
Action Source Description Date
Final  Statutory  MMA sec. 902 requires Medicare final rules publish within 3 years of a proposed or interim final rule.  11/04/2023 

Overall Description of Deadline: Per the CMS notice published December 30, 2004 (69 FR 78442), except for certain Medicare payment regulations and certain other statutorily-mandated regulations, we schedule all Medicare final regulations for publication within the 3-year standardized time limit in the current Unified Agenda. We do not intend to delay publishing a Medicare final regulation for 3 years if we are able to publish it sooner.

Timetable:
Action Date FR Cite
NPRM  11/04/2020  85 FR 70358   
NPRM Comment Period End  01/04/2021 
Final Action  11/00/2023 
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: Federal, State 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: Yes 
Related RINs: Related to 0938-AT21, Related to 0938-AU32 
Agency Contact:
Joel Kaiser
Director, Division of DMEPOS Policy
Department of Health and Human Services
Centers for Medicare & Medicaid Services
Center for Medicare, MS: C5-07-26, 7500 Security Boulevard,
Baltimore, MD 21244
Phone:410 786-6506
Email: joel.kaiser@cms.hhs.gov