Tuesday, December 10, 2019

Very Brief Blog: Legislation Improved, Re-Introduced, Supports Breakthrough Devices at Medicare

In August 2019, I reviewed the complex several year history of improvements on breakthrough device coverage at CMS - here.

One item I discussed was Breakthrough Bill coverage legislation - from the prior Congress.   Similar legislation has now been updated and improved and introduced in the House.  It's introduced by Congr. DelBene of Washington, with 5 cosponsors.
  • See AdvaMed press release here.
  • See MDDI here.
  • See MedTechDive here.
  • See text of HR 5333 here.
  • Expect title as, "The Ensuring Patient Access to Critical Breakthrough Products Act of 2019."
Every year there are always a lot more bills numbered and introduced, than passed, but it's great to see this legislation moving forward on its pathway.

Going back to my August 2019 blog, I mentioned that CMS had been working on rulemaking related to breakthrough devices.  No news on that front.

AdvaMed writes:
The Advanced Medical Technology Association (AdvaMed) issued the following statement from President and CEO Scott Whitaker on the introduction of legislation in the U.S. House by Reps. Suzan DelBene (D-Wash.), Jackie Walorski (R-Ind.), Tony Cardenas (D-Calif.), Gus Bilirakis (R-Fla.), Roger Marshall (R-Kan.), and Terri Sewell (D-Ala.) to streamline Medicare coverage and reimbursement processes for innovative medical technologies:  
“CMS has made great strides in recent months to ensure Medicare beneficiaries have access to the most innovative medical care, and this important legislation would build on these critical reforms,” said AdvaMed president and CEO Scott Whitaker. “We thank Reps. DelBene, Walorski, Cardenas, Bilirakis, Marshall, and Sewell for their leadership and their commitment to ensuring patients and physicians benefit from breakthrough medical technologies in a timely manner. We look forward to working with Congress, CMS, and other key stakeholders to move the bill forward.” 


Note, as of 12/10, the bill is numbered and a website created but the text of HR 5333 was not entered online yet.