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New CMS Rule Unlikely to Speed Medicare Coverage of Breakthrough Devices

by | Sep 6, 2023 | News, Open Content

The recently proposed TCET rule appears to be too stringent to significantly hasten the Medicare coverage process for device makers.

After choosing not to proceed with a proposed rule that would have provided Medicare beneficiaries fast coverage for medical devices that receive FDA Breakthrough Device Designation, the Centers for Medicare & Medicaid Services (CMS) has created a new rule for coverage of such products.

However, according to an article in G2 Intelligence’s September 2023 National Lab Reporter (NLR), while the original “Medicare Coverage of Innovative Technology (MCIT) and Definition of ‘Reasonable and Necessary’” rule was criticized for not being strict enough, it appears that the new Transitional Coverage for Emerging Technologies (TCET) rule goes too far in the other direction.

The proposed TCET rule would allow medical device makers, including manufacturers of diagnostic tests, that have Breakthrough Device Designation for their products to pursue the TCET pathway for faster Medicare coverage for those tests or devices. This would allow Medicare beneficiaries to gain quicker access to innovative products.

Some key differences of the TCET rule:

  • Products won’t automatically meet Medicare coverage criteria when they receive FDA marketing authorization
  • Manufacturers will need to go through a stringent three-stage process to ensure their products are safe and effective

But according to the recent NLR article, this process appears too onerous to significantly speed up Medicare coverage for breakthrough devices. Even if their products successfully make it through the TCET pathway, device makers will “still have to navigate the basic Medicare National Coverage Determination (NCD) system,” the article points out.

To read the full article, “New CMS TCET Rule Likely Won’t Hasten Medicare Coverage of Breakthrough Devices,” sign in to your NLR subscription, or sign up for a free trial.