Medical Device Daily Washington Editor
The Centers for Medicare & Medicaid Services has published what is unlikely to be the final iteration of its revised clinical trial policy for national coverage determination (NCD), which deals with Medicare coverage for beneficiaries who participate in clinical trials.
The agency published the preliminary version April 10 (Medical Device Daily, April 13), and the subsequent comment period generated responses that prompted CMS to modify the proposal.
In a statement, CMS said this iteration will include an additional comment period, this time for 30 days, although the policy took effect this past Monday.
The full announcement, posted at the CMS web site, says this is due to a perception that "the public has not had an adequate opportunity to comment on" apparent discrepancies between the proposed clinical trial policy (CTP) and "additional Medicare policies and statements" in reference to the previous CTP, which was published in 2000.
"This decision will expand access for Medicare beneficiaries to participate in clinical trials that seek to establish better evidence for the management of care and treatment of Medicare beneficiaries," said acting CMS Leslie Norwalk.
The full CMS statement notes that the agency received several comments after the April 10 publication that suggested that "Medicare contractors had been paying claims for hospital services involving patients in various types of clinical trials outside the terms of the 2000 CTP." These entities apparently "sought assurances that coverage will continue for the usual patient care associated with research in a hospital."
Much of the difficulty stems from the fact that the 2000 CPT language permitted an interpretation that the agency would not reimburse hospitals for clinical trials for devices already covered, regardless of whether the study proposed to examine off-label use or was designed to refine current use or the associated surgical procedure.
The initial draft of the 2007 CPT did nothing to allay such concerns, and when the agency sought comment on the matter after publication of the April draft, device makers made their voices heard.
They said that, should such an interpretation hold, hospitals would not be able to serve as study sites unless device makers wanted to absorb the cost of the device as well as any other costs.
Another sticking point of the policy — one that CMS is still chipping away at — is that the agency still does not have an explicit policy for approval of post-market studies of devices that are not deemed by a deeming body.
Most federal agencies, such as the National Institutes of Health and the Centers for Disease Control and Prevention , do not deem such studies, and the only deeming power FDA exercises for post-market studies are those requiring a sponsor as a condition of approval.
Hence, a device maker that wishes to refine the function of a covered device or the associated procedure has little avenue for moving such studies forward. The same would presumably hold for studies of off-label use.
Ann-Marie Lynch, executive VP for payment and health care delivery policy at the Advanced Medical Technology Association (AdvaMed; Washington), said in a statement, commenting on the policy, that the association is "very pleased that Medicare beneficiaries will continue to have the opportunity to participate in a wide range of clinical research" and that the policy "not only expands the evidence base for individual clinical decision-making, it also improves quality of care and furthers medical innovation."
Parashar Patel, VP for health economics and reimbursement for Boston Scientific (Natick, Massachusetts), told Medical Device Daily that the company is "pleased that CMS clarified its clinical trial policy and that it is taking additional time to consider issues raised by Boston Scientific and other stakeholders regarding the effect of clinical trial policy on Medicare patients, hospitals, physicians, and other stakeholders. We're also pleased that CMS has provided another pathway for Medicare patients to access promising new technology by adding coverage with evidence development to the clinical trial policy."
House considering FDA reauthorization
Consumers Union (CU; Yonkers, New York) has weighed in on behalf of the House version of the FDA reauthorization bill, which was on the docket for the House yesterday (at press time, the vote had not taken place) after being nudged off the agenda for the previous day.
Jim Guest, CU's president, described the bill as "the strongest improvement in the Food and Drug Administration in 45 years," adding that the bill "will help ensure safer prescription drugs for future generations of Americans."
The ink is already dry on the Senate's version (S. 1082), which like H.R. 2900, includes slightly less than $400 million in user fees to boost drug safety monitoring, and gives the FDA increased authority for the safety of drugs once they are already on the market, such as requiring drug companies to add warning labels and conduct post-market safety studies.
However, the House version also mandates a review of a drug's safety at seven years post-market and requires that any funds collected from industry for safety review will be allocated toward specific actions, such as reducing the backlog of uncompleted safety studies.
The House bill would also allow FDA to require drug makers to submit all DTC ads for review prior to airing or publishing,
While both bills would fund a public clinical trials database to disseminate safety and efficacy data, the House bill requires that the site be up and running within a year of its passage, whereas the S. 1082 would give the agency more than two years to evaluate the idea before "going live."
The House bill also would limit the number of advisory committee members requiring a waiver of conflict of interest to one per panel whereas the Senate bill imposes no such restrictions.
In a statement, Guest said that the public "simply has not been given the full story about all the potential risks of medications," and that "Congress must pass this bill, which will significantly strengthen our drug safety laws and adequately fund safety efforts at the FDA."