News at a Glance – Sep 2015

FDA Establishes First Patient Engagement Advisory Committee. Recognizing the shift to “patient-centered medicine,” the U.S. Food and Drug Administration (FDA) is establishing the first-ever Patient Engagement Advisory Committee (PEAC) to advise the FDA Commissioner on issues regarding medical devices, their regulation and use. In a recent FDA Voice blog announcing the new committee, Nina L. Hunter, Ph.D., a regulatory scientist in the FDA’s Center for Devices and Radiological Health and Robert M. Califf, M.D., deputy commissioner for Medical Products and Tobacco, wrote: “Americans are becoming increasingly active consumers of health care, making choices about their doctors, diagnostics, treatments, and health care experiences rather than simply allowing health care providers to make the decisions for them.” The authors cautioned, however, that while patients can help the agency “define meaningful benefits or unreasonable risks” of new devices, patient preference information won’t be used “to justify approval of unsafe or ineffective devices.” Nominations for voting members are due by Nov. 20, 2015 to receive first consideration for membership. Nominations received after that date will be considered for future vacancies. The FDA is soliciting comments through Nov. 20, 2015 regarding potential topics for the Committee to address.

CMS Releases Proposed Rule Implementing PAMA. As we went to press, the Centers for Medicare & Medicaid Services (CMS) announced a proposed rule, to be published Oct. 1 in the Federal Register, implementing the Protecting Access to Medicare Act of 2014 and requiring Applicable Laboratories to report private payer reimbursement data regarding laboratory testing. Applicable Laboratories would be those receiving at least $50,000 under the Clinical Laboratory Fee Schedule and “more than 50% of Medicare revenues from laboratory and physician services.” Such laboratories would need to report private payer payment rates and volume of services. If an organization includes multiple facilities, not just laboratories, that 50% threshold is calculated based on the Medicare revenue for the entire organization—so the organization must receive more than 50% of its entire revenue for all components, not just its laboratories, from payments under the Clinical Laboratory Fee Schedule and Physician Fee Schedule. Comments on the proposed rule are due by Nov. 24, 2015. We will address the proposed and eventual final rules in more detail in future issues.

Two FDA Workshops Focus on Precision Medicine Issues. The Food and Drug Administration announced two workshops that will follow-up on issues discussed at a February workshop addressing next-generation sequencing. The first workshop, to be held Nov. 12 will focus on potential analytical standards for next-generation sequencing based in vitro diagnostic tests, including laboratory developed tests. The FDA seeks “sufficiently flexible assay performance standards that can accommodate innovation, including test modifications, while assuring NGS test safety and effectiveness.” The FDA promises a white paper in advance of the workshop that will cover its “current thinking for a standards-based approach to analytical performance evaluation of NGS diagnostic tests.” A second workshop will be held the next day, Nov. 13, addressing use of databases to establish clinical relevance of human genetic variants. The workshop will focus on development, operation and curation, and use of databases of genetic variants. For both workshops, attendees must register for in person or webcast attendance by Oct. 30, requests to make public comment must be made by Oct. 26, and written comments on the issues can be submitted until Nov. 25, 2015. Registration, agendas and other information for both workshops can be found on the FDA’s website.