Federal Update: Breakthrough Technology Rule Not So Breakthrough

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Breakthrough Technology Rule Not So Breakthrough

86 FR 26849: Centers for Medicare & Medicaid Services (“CMS”) has, for a second time, delayed the rule that expedites the FDA approval process for breakthrough technologies for Medicare coverage until December 15, 2021. Looks like the next stop for this rule is cancellation. 

HHS Issues Final Rule on Notice of Benefit and Payment Parameters for 2022 and PBM Standards

86 FR 24140: The U.S. Department of Health and Human Services (“HHS”) announced its rule that finalizes some of the standards included in the proposed rule for states, exchanges, non-federal governmental plans, issuers in the individual and small-group markets, and web brokers. This rule, among other things, furthers HHS’s efforts on health equity by lowering maximum consumer out‑of‑pocket costs by $400. In addition, this finalizes the rule for collecting prescription drug data directly from Pharmacy Benefit Managers (“PBMs”). HHS hopes that this rule will allow it to understand the cost of prescription drugs provided in exchange plans, as well as shed light on the role that PBMs play in those cost. 

CMS Issues Interim Rule on Long-Term Care Facilities Regarding Vaccines

86 FR 26306: This interim final rule revises the infection control requirements that long-term care (“LTC”) facilities and intermediate care facilities for individuals with intellectual disabilities (“ICFs-IID”) must meet to participate in the Medicare and Medicaid programs. The rule aims to reduce the spread of COVID-19 by requiring education about vaccines for LTC facility residents, ICF-IID clients, and staff serving both populations, and that such vaccines, when available, be offered to all residents, clients, and staff. It also requires LTC facilities to report COVID-19 vaccination status of residents and staff to the Centers for Disease Control and Prevention (“CDC”). The rule solicits public comments on the potential application of these or other requirements to other congregate living settings over which CMS has regulatory or other oversight authority. Comments are due on July 12, 2021.

CMS Amends Rule to Conform to Bates County Memorial Hospital Decision

86 FR 24735: This interim final rule amends current CMS regulations to bring them in line with the recent US District Court decision in Bates County Memorial Hospital v. Azar, which held that Section 1886(d)(8)(E)(i) of the Social Security Act (the “Act”) requires that CMS treat qualifying hospitals as being located in the rural area for purposes of Section 1886(d) of the Act, including Medicare Geographic Classification Review Board ("MGCRB") reclassification. To put it simply, the Bates decision requires that CMS consider the rural area to be the area in which the hospital is located for the wage comparisons required for MGCRB reclassifications.

CMS Announces Continuation of Durable Medical Equipment Fee Schedule Adjustments to Resume the Transitional 50/50 Blended Rates to Provide Relief in Rural Areas and Non-Contiguous Areas

86 FR 21949: CMS announced the continuation of a Medicare interim final rule (83 FR 21912-01) and the extension of the timeline for publication of the final rule with regard to the 50/50 Blended Rates in the Durable Medical Equipment Fee Schedule for rural and non-contiguous areas. This extension will grant policy officials the opportunity to review the interim final rule while maintaining its effectiveness beyond May 11, 2021.