AdvaMed sets out its priorities for new Congress

Regulatory NewsRegulatory News | 17 January 2023 |  By 

AdvaMed CEO Scott Whitaker. (Source: AdvaMed)

As the 118th Congress gets underway, the medical device lobby group AdvaMed is focused on ensuring that lawmakers prioritize issues such as diagnostics reform and Medicare coverage for breakthrough devices. AdvaMed CEO Scott Whitaker said that the group is working with multiple legislators to achieve their objectives.
Last year, AdvaMed spent much of its effort lobbying Congress to pass the Medical Device User Fee Amendments (MDUFA V) and the Verifying Accurate Leading-edge IVCT Development Act (VALID). While the latter piece of legislation wasn’t ultimately passed into law, Whitaker told Focus he’s already gearing up to ensure the US Food and Drug Administration has the authority to regulate laboratory-developed tests (LDTs).
“We got very close to getting that done last year, said Whitaker. “It sort of fell out as a result of the size of the omnibus spending bill and the ability of one or two individuals to sort of muck it up at the last minute.”
FDA has long pressed for greater authority to regulate LTDs, including through the bipartisan VALID Act. It was proposed as part of the omnibus spending bill last year but didn’t make the cut after Rep. Cathy McMorris-Rodgers (R-WA) protested the bill. (RELATED: FDA official says pandemic reauthorization bill could drive VALID across finish line, Regulatory Focus 13 January 2023)
Now McMorris-Rodgers is chair of the powerful House Energy and Commerce (E&C) Committee, which will be key to bringing the bill up for discussion and getting it passed into law in the new Congress. On the Senate side, VALID was supported by Sen. Patty Murray (D-WA), former chair of the Health, Education, Labor and Pensions (HELP) Committee. But now that position has been taken over by Sen. Bernie Sanders (I-VT), who is known for his progressive politics and antipathy toward lobby groups.
Despite the change in the political make-up of the committee leaderships, Whitaker is optimistic the VALID Act has the support it needs to be passed into law.
“If you take McMorris-Rodgers at her word, what she said was that she didn't have concerns about VALID per se, but that it was really a process issue for her,” Whitaker noted. “She felt like it didn't go through the committee process.”
“My understanding is [lawmakers] have every intention to run it through the process they believe is the right process this year,” he added. “Let's hope that that's right, and if they do, I think what you'll find is there’s broad bipartisan support for VALID, or some version of VALID that's very similar to what we got done last time around.”
Whitaker is also confident that, at least in principle, Sanders would be supportive of the act because it is meant to provide better and more consistent regulation of diagnostic products.
“But as with most of these things it requires more than just us saying it's a good thing to do, or an important thing to do,” Whitaker said. “It's going to require FDA engaging with the committees to help them understand why it needs to be done. It's going to take bipartisan members of both the House and the Senate, to talk to the committee chairs and help move things.”
“I don't think any of the changes in Congress are significant enough to derail the work that we've done or really threaten VALID based on what they have said to us,” he added.
While the lobby group pushes to get diagnostics reform passed in Congress, FDA Commissioner Robert Califf said he may consider publishing a rule to give FDA regulatory oversight over such products if Congress fails to act. Whitaker said he’s supportive of FDA’s rulemaking efforts, if that’s the direction the agency goes. (RELATED: Califf: FDA may use rulemaking for diagnostics reform if VALID isn't passed, Regulatory Focus 25 October 2022)
“If FDA decides that they're going to do something from a regulatory standpoint to address this VALID-like issue in whatever form they feel like they can … we'll work with them to advance the concept and we’ll be very dialed in,” Whitaker added.
Another of AdvaMed’s priorities is creating an alternate coverage pathway at the Centers for Medicare and Medicaid Services (CMS) for breakthrough medical devices called the Transitional Coverage for Emerging Technologies (TCET). Industry has long complained that its breakthrough products end up in a “Valley of Death” after they enter the market because CMS refuses to reimburse the products until there’s more clinical data on their efficacy.
At the end of the Trump administration, the CMS was on track to create a new pathway called the Medicare Coverage for Innovative Technologies (MCIT). It would have granted automatic Medicare coverage for breakthrough devices for up to four years, during which time manufacturers could gather the clinical data needed to prove the efficacy of their products.
The Biden administration has said it is considering the issue, but AdvaMed is hoping it can lobby lawmakers in Congress to pass legislation this year to make TCET a reality. The proposal could face opposition from Sanders, who may be leery of CMS covering products before gathering enough data to support their clinical efficacy.
Whitaker said he is optimistic that Sanders will support TCET if it comes up for discussion in Congress.
"What [TCET] is about is getting patients in Medicare access to new technologies, and as a senator who's very supportive of concepts like Medicare for all, I'd be surprised if he doesn't think it's a good idea that everyone who's on Medicare gets access to new technologies," said Whitaker.
"Concerns about more access has never been something that I've heard from Bernie Sanders,” he said. “In fact, the opposite. So, I'm optimistic that he'll support the concept because it's in the best interest of patients in the Medicare program, which he supports."
The other top priority for AdvaMed this year is to track the success of the MDUFA V program. Under the claw-back provisions of the deal negotiated with FDA, industry agreed to metrics that the agency would need to meet to qualify for additional funding next year. (RELATED: MDUFA V: Commitment letter includes TPLC pilot, claw back provisions and more, Regulatory Focus 23 March 2022)
Whitaker said that while AdvaMed will work with FDA to track metrics in its review process, it also plans to gather feedback from its members about the consistency and speed with which the agency is reviewing products to see if it is upholding its end of the deal.


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