Thursday, December 3, 2020

Op Eds Diss Medicare's Proposal for Breakthrough Device Coverage

In August, CMS formally proposed new regulations that would grant four years of Medicare coverage to all devices approved under the Breakthrough Device pathway at the FDA.  Now, a few weeks after the close of the comment period, two high-profile Op Eds have appeared which are highly critical of the CMS proposal.


In August, CMS formally proposed new regulations that would grant four years of Medicare coverage to all devices approved under the Breakthrough Device pathway at the FDA.  (All current bundling, coding, and payment rules would still apply.)   The acronym is "Medicare Coverage for Innovative Technologies," or MCIT.

This broad proposal followed 2019 rulemaking which gave a privileged position to breakthrough devices when products are reviewed in the New Technology Add On Payment (NTAP) inpatient pathway.  The comment period closed in early November and the rule could be finalized at any timepoint from right now, to the next couple years, to never.

Breakthrough devices are a form of accelerated approval, and the status is assigned early in the device review process.  It applies to 510(k), PMA, and de novo 510(k) products.  Factors that lead to breakthrough review include unmet need, severe or potentially fatal illnesses, new technology, and superior performance.  

Two Negative Op Eds

This week, two negative Op Eds about the program have appeared, one in New York Times, one in Health Affairs.   

  • The New York Times Op Ed is by Memorial Sloan Kettering's Peter Bach.
    • Find it here.
    • His concerns are broader than breakthrough devices.  Medicare and Medicaid have troubles under Trump,  problems including the overly lax result of the Breakthrough proposal,  sharp proposed cuts in payment levels to physicians using injected drugs (like chemotherapies), and the "poorly designed experiment of taking Medicaid coverage away from able bodied people who are not working."
    • The op ed attracted 267 comments by 12/3.  
    • The NYT rapidly published a response from Seema Verma, head of CMS, defending the several programs as important policy advances - find her letter here.   
      • See also CMS's original press releases on the MCIT rulemaking here and here.
  • The Health Affairs Op Ed is by Peter Neumann and James Chambers of the evidence evaluation center at Tufts.
    • Find it here.
    • This article focuses only on the Breakthrough proposal.  It's titled, "Eroding Progress on Evidence and Outcomes."  
    • Sound bite:  "The proposal threatens to erode decades of progress in requiring that adequate scientific evidence relevant to Medicare patients, not simply FDA approval, underlie medical technologies."

Additional Background

Breakthrough at FDA. The Breakthrough Device program was established by Congress via the 21st Century Cures Act in December 2016.   It's an accelerated approval program, with guidance and rules provided via many pages of information at the FDA website.  Here.  

It's a review pathway, not an FDA endorsement of the end result.  For example, in early trials, a device might merit Breakthrough Review if it looks likely to be 50% better than standard of care.  It will still have gone through the Breakthrough Pathway if, at the end of pivotal trials, it only matched the standard of care.   

Finding Out About Breakthrough Devices.  FDA doesn't announce the award of breakthrough status. It's known only if the manufacturer announces it, such as through a press release.  Some devices awarded and announced might have been later dropped from development by the developer, and you wouldn't necessarily know.
  • One source of collated information on BT devices is a review article (with an overall critical tone) by Johnston et al. in Nature Biotechnology, July 2020 (here).  They collated "gray data" e.g. press releases, to present a database of approved and announced breakthrough products.  
CMS Proposal Quirky re Diagnostics.  The CMS proposal is quirky regarding diagnostics.  The proposal regulation covers all breakthrough devices, and there's no question at all that breakthrough devices include diagnostics.  However, in the body of the proposal, CMS authors asked the public if they should ALSO include OTHER categories of breakthrough products, such as "diagnostics or drugs."   This could mean that the CMS authors thought that "devices" meant medical-surgical devices and "diagnostics" were something else.  I was paranoid that the final rule might have been revised to exclude diagnostics and that such an action would be justified by the presence of these odd statements sprinkled around the discussion section.  (My September blog here, and I returned to the topic in October here.)


Historical Note.  The idea of coordinated coverage of breakthrough devices has been discussed by FDA and CMS leaders for several years, and their were several generations of informal proposals or rumors, but the appearance of the rule on August 31 was a surprise to many.  See a history blog in August 2019 here.