“Last week, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule to repeal the Medicare Coverage of Innovative Technology (MCIT) and Definition of ‘Reasonable and Necessary’ final rule (the ‘Proposed Rule’), which CMS published on January 14, 2021 in the waning days of the Trump administration (the ‘January Final Rule’). If it were to go into effect, the January Final Rule would be effective on December 15, 2021. In the Proposed Rule, CMS stated that it is seeking comments until October 15, 2021 on this proposed repeal of the January Final Rule and on CMS’s intent to conduct future rulemaking exploring an expedited coverage pathway that provides access to innovative beneficial technologies and defining ‘reasonable and necessary…'”
“CMS’s Rationale
In the Proposed Rule, CMS articulated its concerns with the January Final Rule, stating that it believes the January Final Rule is not in the best interest of Medicare beneficiaries. CMS has concerns that the January Final Rule may provide multi-year, broad, national coverage for medical devices based on breakthrough designation alone, when the breakthrough designation alone does not provide adequate evidence that such device is the reasonable and necessary treatment for a Medicare patient who has the disease or condition that the device is intended to treat or diagnose.”
“Additionally, CMS made particular note of the fact that FDA does not require that Medicare beneficiaries be included in clinical studies that are required for market-authorization of a medical device. The Proposed Rule hints that CMS feels this fact is a potential blind spot, particularly because the Medicare population consists of older people with comorbidities, and due to the Medicare population’s general underrepresentation in underlying clinical trials. CMS believes these facts make it difficult to assess whether the breakthrough devices are reasonable and necessary, as it is unclear whether the item/service would improve a Medicare beneficiary’s health outcome.”
“Based on the foregoing, while not abandoning the aims of the January Final Rule, CMS does not believe the January Final Rule, as currently drafted, is the best way to achieve the goals of the various stakeholders. We expect that, in exploring its options in future rulemakings, CMS will likely require manufacturers that participate in new coverage pathways, like MCIT, to produce evidence to demonstrate the benefit of the device within the Medicare population…” Read the full article here.
Source: CMS Proposes to Repeal MCIT Final Rule – By Dan Kagan, September 22, 2021. Morrison & Foerster LLP.
