Federal Regulatory Update

For more information about this blog post, please contact Khaled J. KleleRyan M. MageeLabinot Alexander Berlajolli, Brianna J. Santolli, or Connor Breza.

CMS Issues Final Rule on Adjusting DMEPOS Fee Schedule

86 FR 73860: Centers for Medicare & Medicaid Services (“CMS”) has issued a final rule establishing methodologies for adjusting the Medicare durable medical equipment, prosthetics, orthotics, and supplies (“DMEPOS”) fee schedule amounts. This final rule also classifies adjunctive continuous glucose monitors as durable medical equipment (“DME”) under Medicare Part B. More information about the proposed rule can be found in CMS’s Fact Sheet. The final rule is effective February 28, 2022.

CMS Issues Proposed Rule on Benefit and Payment Parameters for 2023 

87 FR 584: CMS has issued a proposed rule regarding, among other things, payment parameters and provisions related to the risk adjustment and risk adjustment data validation programs, as well as proposed 2023 user fee rates for issuers offering qualified health plans through federally‑facilitated Exchanges and State‑based Exchanges on the federal platform. Additional information about the rule can be found in CMS’s Fact Sheet. Comments are due January 27, 2022.

CMS Officially Rescinds Most Favored Nation Model

86 FR 73986: CMS has officially rescinded the Most Favored Nation (“MFN”) Model. As explained in our prior Update, in November 2020, CMS issued the MFN Model interim final rule (85 FR 76180, the “November 2020 proposed rule”) that proposed a drug pricing model that would match payments for Medicare Part B drugs and biologicals to the lowest price paid by other comparable countries. After several federal district courts intervened to prevent implementation of the MFN Model, in August 2021, CMS issued another proposed rule (86 FR 43618) that would rescind the November 2020 proposed rule. This final rule rescinding the MFN Model is effective February 28, 2022.

OIG Revises Regulations on Advisory Opinions

87 FR 1367: The Office of the Inspector General (“OIG”) has issued a final rule amending the regulations governing the procedures for the submission of advisory opinion requests to, and the issuance of advisory opinions by, OIG. Specifically, the final rule removes the procedural requirement at 42 CFR 1008.15(c)(2) that precludes the acceptance of an advisory opinion request and/or issuance of an advisory opinion when the same or substantially the same course of action is under investigation or has been the subject of a proceeding involving the Department of Health and Human Services (“HHS”) or another governmental agency. In removing this requirement, OIG hopes to increase flexibility in responding to requests for advisory opinions and transparency for industry stakeholders in assessing compliance with federal fraud and abuse laws. The final rule is effective February 10, 2022.