Medmarc Insurance Group
The Centers for Medicare & Medicaid Services has formally scuttled its proposal to cover breakthrough medical devices, but recent developments have breathed new hope into the Medicare Coverage of Innovative Technology (MCIT) proposal. Roughly five dozen members of the House of Representatives have urged CMS to reinstate the rule, a recommendation with which apparently the agency has agreed.
CMS announced the full withdrawal of the MCIT rule late last year after having expressed misgivings about several aspects of the rule. One of the considerations cited by the agency is that the pivotal studies for some of these breakthrough medical devices do not always provide conclusive evidence that the device is reasonable and necessary for patients who make up the majority of Medicare beneficiaries. The agency also stated that first-day coverage upon FDA approval or clearance was not practicable, given the associated issues of coding activities that typically take place prior to coverage.
In response to that withdrawal, more than 60 members of the House wrote to CMS to urge the agency to develop a policy to cover devices in a manner that would provide breakthrough device coverage. The letter points to the bipartisan support for the MCIT rule, and to the fact that many pharmaceutical products enjoy Medicare coverage immediately upon FDA approval. The congressional letter stated that the on-again/off-again process invoked by CMS impeded patient access to devices, and that the authors of the letter stated that they do not support withdrawal of the MCIT rule.
However, the letter states that a new rulemaking process should carry over the key elements of the MCIT rule, such as immediate or near-immediate coverage of breakthrough devices. This would apply retroactively as well as prospectively, and would endure for a “similarly reasonable period of time.”
CMS apparently agreed to reconsider the question as indicated by a new entry at the website for the White House Office of Information and Regulatory Affairs (OIRA). This entry at the OIRA dashboard calls for the process to be concluded by October 2022, giving CMS nine months to go through the rulemaking process.
One of the sources of mixed congressional signals is that Section 404 of the Cures 2.0 legislation, a follow-up to the 21st Century Cures Act, includes provisions for breakthrough device coverage. This bill was reintroduced Nov. 16, 2021, seven days before the date of the letter from the House of Representatives. However, Rep. Suzan DelBene (D-Wash.) also has a bill specifically for breakthrough device coverage, the Ensuring Patient Access to Critical Breakthrough Products Act of 2021, giving Congress two means of imposing a statutory breakthrough device coverage mandate on CMS. DelBene’s bill would make coverage retroactive through March 2019.
FDA Regulation of LDTs Reinstated
There were a number of key med tech policy developments in 2020 and 2021 beyond the MCIT rule, one of which was the rescission of the FDA’s authority to regulate lab-developed tests (LDTs). The Department of Health and Human Services (HHS) has reversed that rescission, although this does little to relieve labs and the FDA of the question of the agency’s authority to regulate the “home-brew test.”
HHS issued the rescission order in August 2020, although questions about the agency’s authority date back several decades. The scope of the order was not limited to the COVID-19 pandemic, although test availability for the pandemic seemed to play a role in prompting the Trump administration to act on the question at that point.
The Biden administration reversed that rescission in mid-November 2021, although HHS Secretary Xavier Becerra had little to say about the change. Becerra made reference to an FDA update to its policies regarding LDTs for the pandemic, including a withdrawal of the policy that allowed LDTs for the SARS-CoV-2 virus to be practiced without an emergency use authorization or a conventional premarket filing.
The Verifying Accurate Leading-edge IVCT Development (VALID) Act is still in play on Capitol Hill, and the most recently available version of the legislation creates a two-tiered approach to risk. This is in line with the approach described in the FDA’s technical assistance of 2018, an approach that will be difficult to harmonize with other nations’ regulations, which typically use a four-tier approach to risk.
The VALID Act is likely to pass into law via the legislation for the next user fee schedule, which has to be passed by the end of September 2022. The FDA will have to then develop a regulation with the usual notice-and-comment process required for rulemaking. This process is likely to play out over three or more years, suggesting that the current state of unease regarding FDA regulation will be in place for the foreseeable future.
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