FDA Guidance Updates Categorization Policy For IDEs, Expedites CMS Coverage
The FDA has issued a guidance that would streamline and clarify the categorization process for investigational device exemptions (IDEs). While the Advanced Medical Technology Association (AdvaMed) is still reviewing the document, a spokesperson commented that updated policies would expedite Centers for Medicare and Medicaid Services (CMS) coverage and increase patient access to new technology and enrollment in FDA-approved clinical trials.
Existing categorization policy — co-written by both FDA and CMS in 1995 — stipulates that investigational devices with outstanding safety and efficacy questions be placed in category A for experimental/investigational devices. Class I, II, or III devices not meeting criteria for category A are placed in category B, the only category to be considered for CMS coverage under certain circumstances, according to the Regulatory Affairs Professionals Society (RAPS).
In December, the FDA and CMS released a Memorandum of Understanding (MOU) that detailed the agency’s difficulties over the past two decades placing devices neatly into categories, or changing categorization for a device once new evidence was presented. According to the MOU, updates to the policy would “streamline and facilitate efficient categorization” and “support the CMS’s ability to make reimbursement decisions.” The guidance, released this week, is intended to implement the MOU.
In the guidance, FDA writes that previous FDA policy did not “adequately articulate” categorization criteria for certain feasibility studies outlined in a 2013 guidance, which described new modifications to existing technology that might raise safety concerns. Additionally, existing policy did not “describe a pathway” for technology to move from A to B when new evidence was submitted.
Updated criteria outlined by the guidance stipulate that devices may move categories when data from early feasibility studies resolve safety and efficacy questions. In other cases, an IDE may be approved for category A with conditions that, once met, would move the device into category B. Device sponsors requesting a category change may file with the agency for an IDE supplement.
“While we are still reviewing the details of the draft FDA guidance, we support efforts to expedite CMS coverage decisions on devices used in FDA-approved clinical trials,” said JC Scott, AdvaMed’s senior executive VP for government affairs, to Bloomberg BNA. “We hope the new guidance will further clear the way for Medicare patients to participate in IDE trials.”
Theodore Sullivan, an attorney at a Washington-based law firm Quarles & Brady, told Bloomberg BNA that the existing policy is overly complicated and the guidance is a “good step” toward making the process more efficient.
Comments on the IDE guidance will be accepted through Aug. 2, 2016.
Sen. Dan Coats (R-Ind.) recently introduced legislation that would address Medicare coverage for new technology that already has been cleared by the FDA, with the hope of accelerating access to breakthrough technology that treats serious illness. This bill, if passed, would grant temporary CMS coverage to new technology for three years, during which time CMS could stipulate what additional data would be necessary to continue reimbursement following the trial period.
President and CEO of AdvaMed Scott Whitaker commented that the legislation would “bridge the gap” between the FDA and CMS, with regard to breakthrough medical technology.
“These CMS reforms would both stimulate development of important new devices and diagnostics and assure more timely patient access to new treatment options,” said Whitaker in a statement.