The Advanced Medical Technology Association (Advamed) has gone virtual with its annual conference, thanks to the COVID-19 pandemic. However, the pandemic hasn’t affected the term of eligibility for the Medicare new technology add-on payment (NTAP) program. Don May, Advamed’s executive vice president for payment and health care policy, said on a Sept. 11 press briefing that any device that misses its first year of NTAP eligibility may not be able to recover that year unless the Centers for Medicare and Medicaid Services (CMS) makes an exception for the pandemic, seemingly leaving the Boston Scientific (BSX) Eluvia device with only two years of eligibility for its NTAP application.
Advamed kicked off its annual med-tech conference in virtual fashion but cut short the planned one-hour press conference at 45 minutes. The question of the Eluvia paclitaxel-eluting stent for the lower limbs has been topical for the past year, thanks to the CMS decision to omit the device from the NTAP program for the fiscal 2020 Medicare inpatient fee schedule due to the controversy over paclitaxel, which arose in connection with the December 2018 Katsanos paper in the Journal of the American Heart Association.
The CMS included the Eluvia in the NTAP program for FY 2021, thanks to the emergence of data that relieved the agency’s concerns about a purported association between the antiproliferative and late death. However, representatives of Marlborough, Mass.-based BSX indicated they were uncertain as to whether the company would be able to reclaim the lost year of NTAP eligibility.
In response to a question posed by BioWorld, Advamed President and CEO Scott Whitaker said the NTAP program is “a regulation, and so they have some flexibility to some degree. But once it’s out, I think it’s locked in” at three years of eligibility post-U.S. FDA approval. May said the CMS would have to resort to a modification of the rule in order to accommodate problems associated with the pandemic, adding, “at this point, I don’t think they’ve proposed anything like that.”
May said Advamed had posed the question in its comments to the docket for the draft inpatient rule, but that the agency has been mum to date. “We’ll continue to ask for additional exceptions and waivers to ensure those technologies get the full benefit of those extra payments” during the course of the pandemic, May vowed.
FDA device shortage page discordant with industry’s view
Whitaker said the Advamed pandemic test registry counts more than 145 million tests to date. The registry still is limited to molecular tests, typically conducted as polymerase chain reaction tests, and Whitaker said government officials “have found value in it.” The monthly volume of molecular tests is at least 32 million, a number Whitaker said will grow as summer gives way to autumn.
Whitaker said he is not aware of any specific shortages of the various devices, testing supplies and equipment needed for the pandemic, but noted that while device makers have met the production demand for ventilators, production for diagnostic and surveillance testing was probably as challenging as for any other class of products.
The FDA’s pandemic device shortage list still features a number of items, as does the discontinuance list, but the CDC has posted a request for information in the Federal Register inquiring into the appropriateness of elastomeric half-mask respirators. Whitaker said he understood “why the government would remain concerned, and I think they should remain concerned,” about product availability.
Still, Whitaker said industry has not seen any direct indications of production shortages. “From our perspective and our conversations, we haven’t seen that at this time,” Whitaker said, although he noted that the picture “could continue to evolve and change.”
Janet Trunzo, Advamed’s executive vice president for technology and regulatory affairs, said the FDA was required by the CARES Act to identify a list of devices for which a potential shortage exists due to supply chain disruption, along with specifically identified shortages. Trunzo said the list “just identifies device types for which the mandatory reporting provisions apply.”
When pressed on the language of the shortages webpage, which states that the list includes “devices the FDA has determined to be in shortage at this time,” Trunzo said it is dynamic and “constantly will change because it is the result of individual company reports, not particularly all the device types for which reporting is required.”
‘Massive scale-up’ of antigen testing predicted
Whitaker said Advamed anticipates “a massive scale-up of antigen testing” in autumn, predicting monthly volumes of 70 million to 100 million tests. He said he is unaware of anything the FDA has done that has throttled industry’s interest in antigen testing, adding, “in our experience, they’ve been very helpful and constructive” in developing regulatory mechanisms and in engaging with test developers to this end. “We feel pretty good about the direction we’re going on antigen testing,” he said.
Regarding the next device user fee, Whitaker made note of the pandemic’s drag on negotiations, adding that the next meeting will be in October. Advamed is not publicizing any specifics regarding its agenda for those negotiations, although the traditional concerns of efficiency in regulatory review, along with transparency and process improvement, are still points of interest for device makers.
Trunzo said the MDUFA V kick-off meeting, slated for Oct. 27, will be followed by a comment period of 30 days, after which the agency and industry will hold the first negotiation meeting. The date for that get-together has not yet been set, but Trunzo said the first negotiation meeting is likely to be at least 60 days away. She pointed out that the final negotiated package is not due on Capitol Hill until January 2022, giving all parties to the conversation ample time to overcome any delays related to COVID-19.