|AdvaMed CEO Stephen Ubl|
AdvaMed CEO Stephen Ubl said the med tech innovation ecosystem is "fraying" at a news conference unveiling the trade association's 2015 Innovation Agenda to fix the ills of the industry.
The agenda has five pillars: Improving FDA's regulatory processes, restructuring Medicare coverage and payment processes, reforming the U.S. tax system, improving access to international markets and supporting a strong R&D infrastructure.
Of particular interest was a proposal to provide automatic Medicare coverage for FDA-approved medical device trials. Ubl said the current process followed by the federal Centers for Medicare & Medicaid for reimbursing those trials is unnecessary because the agency almost always decides to support them in the end.
Automatic coverage would bring medical device trials into parity with the payment systems for drug trials, AdvaMed said.
The proposal to provide Medicare coverage for device trials will be a part of the comprehensive 21st Century Cures initiative to overhaul the government's regulation of the life science industry, Ubl said. Republicans in Congress hope to pass the bill by the end of the year.
The focus on reimbursement highlights the changing concerns of the industry. Under the tenure of FDA commissioner Margaret Hamburg (who's leaving the post soon), the industry's relationship with the FDA has improved, but tighter reimbursement and new payment models in the post-Obamacare world are squeezing medical device companies.
For example, Ubl complained that CMS often provides reimbursement for a narrower range of conditions than a devices FDA-approved indication for use.
In addition, Ubl said that in order to cut the gap between approval times of devices in the U.S. and Europe, which can be multiple years, more early-stage clinical trials must be conducted in the country.
The head of the FDA's device arm (CRDH) Jeffrey Shuren has acknowledged that most device clinical trials are conducted abroad, and made changing that one of his priorities. "FDA's new leadership is clearly not satisfied with where we are now and neither are we," Ubl said.
In a wide-ranging speech, Ubl also mentioned repealing the medical device tax as a priority, calling it a "tax on medical progress," and cited an AdvaMed survey of member companies that found it has cost 39,000 med tech jobs.
Paying for the repeal of the device tax is a big stumbling block to an idea that has bipartisan support. Ubl said "it may or may not require an offset" and hopes that the industry's "champions" in Congress could find a pay-for it were needed.
Many of AdvaMed's legislative goals are staked to the passage of the 21st Century Cures initiative, including the development of a "breakthrough pathway" for faster approval of some medical devices. The legislative proposal builds on the FDA's proposed Expedited Access Pathway, which is currently a draft guidance, AdvaMed said.
Finally, on the diagnostics side, Ubl praised President Obama's "precision medicine" initiative to fund genomic testing of 1 million Americans. That too is slated to be enacted in the 21st Century Cures initiative.
While Republicans agree with AdvaMed on most issues, some have said they disapprove of FDA's plans to regulate lab-developed tests, an initiative that the trade association supports.
Andrew Fish, the president of AdvaMed's AdvaMedDx device arm, said that there is a "placeholder" for the part of the Cures initiative addressing that issue, but said he's confident that the FDA's plans to step up its oversight of LDTs will proceed.
- here's more on the agenda