The House Energy and Commerce Committee has substantially trimmed down its “21st Century Cures” reform wish list in an updated legislative proposal posted April 29, but significant device regulatory reforms, including a breakthrough device priority review program, remain in play.

The updated discussion draft is about half the length of the first version issued in January. It was discussed at an April 30 subcommittee hearing that included testimony from CDRH Director Jeffrey Shuren, as well as FDA drug center Director Janet Woodcock and an official from the National Institutes of Health.

Of note, while the original draft was released by the committee’s Republican leadership, the new version appears to have more bipartisan sign-on. It was released by Committee Chairman Fred Upton, R-Mich., Oversight and Investigations Subcommittee Ranking Member Diana DeGette, D-Colo., full committee Ranking Member Frank Pallone, Jr., D-NJ, Health Subcommittee Chairman Joe Pitts, R-PA, and Health Subcommittee Ranking Member Gene Green, D-Texas.

Breakthrough Review, But Not Reimbursement

The latest proposal retains the breakthrough device priority review program, which is strongly supported by the device industry. As laid out in the January draft, the provision would create an accelerated development pathway for devices that address unmet needs. (See [A#01150202007].)

What’s In, And What’s Out

Provisions in latest Cures draft include:

Breakthrough device priority review
Humanitarian device exemptions: Raises annual patient cap from 4,000 to 8,000
Streamlining FDA recognition of international device standards
Device advisory panel process reforms
CLIA Waiver reforms

Provisions NOT included:

Accelerated Medicare coverage for breakthrough devices
FDA diagnostics regulatory reform
Expanded CMS coverage-with-evidence-development authority
Accelerating Innovation in Medicine Act
Device Distribution Licensing Act (supply-chain protection)

It would build on CDRH’s recently launched “expedited access program” by expanding out the devices that could qualify for the special program. The House proposal, for instance, does not specify a qualifying device needs to address a life-threatening or debilitating condition as CDRH’s EAP program stipulates and the legislative proposal would allow 510(k) devices to qualify as breakthrough devices, while the agency’s current program does not.

The device center, however, has argued that including 510(k)s in the program would not provide much value and would tax CDRH resources to a breaking point. (See [A#01150413013].) The breakthrough device provision is not tied to any funding increase for the agency.

CDRH’s Shuren reiterated the resource challenges that would result from the Cures’ breakthrough device provision at the April 30 hearing. “The challenge will be finding the people to do the work outlined in this provision,” he told lawmakers. (See [A#01150504015].)

Device firms strongly support the Cures breakthrough device proposal, but the latest draft is missing key language that industry is pushing for: a streamlined pathway to reimbursement for breakthrough products. While the January draft included a placeholder section for “CMS coverage of breakthrough devices,” that section is completely absent in the new version.

A committee staffer said the Medicare breakthrough device provision was dropped because it would cost too much.

“We encourage the committee ... to consider additional reforms that address Medicare coverage and payment challenges that restrict access to new technologies that improve patient care,” AdvaMed CEO Steve Ubl said in statement. In addition to accelerated Medicare coverage for breakthrough devices, the trade group is also pressing for reforms to improve the Medicare new-technology add-on payment program and reimbursement coding process.

Most Device Reg Reforms Retained, Revised

Many of the device industry association’s priorities were reflected in the first Cures draft and retained in the updated package. (See [A#01150216008].)

“We are pleased it includes a number of proposals to improve the innovation ecosystem that supports the development of life-saving, life-enhancing medical technology,” Ubl said.

An E&C committee staffer said the Medicare breakthrough device provision was dropped because it would cost too much.

The key device regulatory reforms, beyond the breakthrough device provision, include a few notable revisions, or, in some instances, a lack of legislative details, compared to the earlier draft.

For instance, the latest draft includes placeholder language but no details for a provision that is intended to allow third-party quality system audits, rather than 510(k) or PMA supplements, to support minor device or manufacturing changes, and another provision intended to reduce the FDA notification requirements for class I devices is also only placeholder, likely reflecting ongoing discussions between lawmakers, and with FDA and industry.

During the April 30 hearing, Shuren said he was worried that the third-party quality assessment proposal would not add efficiency for FDA and would end up as a net-cost for the agency. (See [A#01150504015].)

The new draft also retains a provision, including legislative details, that specifies that registries, peer-reviewed journal data and non-U.S. data can all qualify as “valid scientific evidence” for FDA, and another one that would require FDA device staff training and guidance on the almost two-decades-old “least burdensome provisions” of the FDA statute.

The House revised a section intended to increase the number of international device standards that can be used by manufacturers to streamline premarket requirements. Rather than forcing the agency’s hand to either accept all international standards as they are disseminated or provide a written rationale for not accepting a standard, the new proposal would require that FDA respond to specific individual requests to accept a new standard. The new language would also direct FDA to draft guidance on the principles for recognizing device standards.

The House also updated a proposal to make changes to the device advisory committee process. The provision would give device sponsors more of a say in the expertise that is needed for an individual panel meeting, it would also ensure that sponsors have time during a panel meeting to correct “misstatements of fact” or clarify information. There is also some new language that would set some new process standards specifically focused on questions of device reclassification.

A significant new addition to the legislative proposal would double the number of people that could be treated per year with a humanitarian device exemption from 4,000 to 8,000.

Another addition would mandate FDA to refine its approach to assessing in vitro diagnostics that can be waived for use in clinics, doctor’s offices and at the bedside under the Clinical Laboratory Improvement Amendment Act, responding to complaints by kit manufacturers that the current accuracy requirements for a waiver are unwarranted. (See Also see "Coming Together On CLIA Waivers? Industry Hopes To Recruit Patients, Providers To Push Reform" - Medtech Insight, 6 June, 2014..)

The draft also retains the SOFTWARE Act for health IT oversight, and a provision to allow centralized institutional review boards for device trials.

What’s Missing

But there are also some significant reform ideas that were raised in the draft issued earlier this year that are completely absent in the new version. In particular, the earlier draft included a placeholder for comprehensive reform to FDA’s regulation of in vitro diagnostics and lab-developed tests, which was not carried through. Also missing are device supply chain security reforms, combination products oversight reform, and stronger authority to CMS to run the coverage-with-evidence development program.

The House committee also excised the Accelerating Innovation in Medicine Act, which would give device manufacturers the opportunity to make their product available on a self-pay basis while they collect data needed to support reimbursement without running into legal restrictions associated with insurance coverage. (See Also see "AIM Act Touted As One Solution To Device Reimbursement Woes" - Medtech Insight, 12 June, 2014..)

The legislation still remains in draft form, but committee leaders say they are aiming to have legislation ready for markup by Memorial Day. The Senate has initiated a parallel medical innovation reform effort, but the Health, Education, Labor and Pensions Committee is still in the early stages of constructing a legislative proposal. (See Also see "CDRH Can’t Rely On ‘Network of Experts’ Due To Confidentiality Concerns" - Medtech Insight, 29 April, 2015..)

Shortened ‘Cures’ Draft Retains Breakthrough Pathway, Device Reforms

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