Health Reform Innovation Medicaid/Medicare Medicare


The U.S. is one of the the few developed nations without a government-run health technology assessment (HTA) body. Or are they? A recent perspective in the New England Journal of Medicine by Peter Neumann and Sean Tunis argues that the Centers for Medicare and Medicaid Services (CMS) already is serving as a de facto HTA body. They write:

In early 2021, the Trump administration issued final regulations that would extend automatic coverage for breakthrough devices approved by the FDA, granting national coverage for on-label uses for 4 years, after which CMS would determine future coverage status. The Biden administration, worried about paying for products despite insufficient evidence of their benefits and risks, rescinded the regulation, but committed to issuing a modified version of the rule (a proposed procedural notice on the new pathway was issued on June 22), which will further engage CMS in defining evidence requirements for medical device coverage

The authors cite the case of recent Alzheimer’s drugs as an instructive example. When FDA approval a new Alzheimer’s disease therapy, Medicare did decide to cover it, but with a condition that data had to be collected on each patient who used the drug to generate additional evidence on the product’s safety and effectiveness. This is a coverage with evidence development (CED) framework.

The Inflation Reduction Act (IRA) is the most transformational piece of legislation moving CMS towards being an HTA body.

…the 2022 Inflation Reduction Act, which requires Medicare to negotiate drug prices for selected therapies (taking effect with 10 drugs in 2026 and eventually adding 20 per year), further expands CMS’s technology-assessment activities. Negotiating prices inescapably means judging the benefits, risks, and costs of alternative treatments. 

Due to all these changes, the authors argue that “like it or not, CMS has already become a major HTA body.” They also argue for three ways to improve how CMS evaluates new innovative treatments:

  • Upskill. CMS should add staff with expertise in clinical research, trial design, epidemiology, and biostatistics
  • Improve coordination with FDA. For instance, CMS could participate in earlier interagency discussions with FDA and manufacturers about clinical development programs to identify potential discrepancies between the agencies’ requirements related to end points and post-marketing commitments for regulatory and access reasons. They note that FDA-CMS have engaged in “parallel review” for medical devices for over a decade.
  • Strengthen CED. The authors also propose that recent trends towards more robust CED monitoring are a step in the right direction.

You can read the full perspective article here.