ARTICLE SUMMARY:
Medicare moves to clear up a next-generation sequencing coverage mix-up; the escalating coronavirus outbreak is driving attention toward diagnostic emergency-use approval policies in China and the US; EU policymakers issued a 2020 meeting agenda, and more in this week’s Pathways’ Picks, Market Pathways’ weekly roundup of the most important global medtech regulatory, reimbursement, and policy news. Pictured: A railway station in China's Wuhan Province, ground zero for the coronavirus.
The Centers for Medicare and Medicaid Services removed coverage restrictions on next-generation sequencing testing as a treatment guide in early-stage inherited cancers. Diagnostics are also increasingly a focus of governments trying to respond to the coronavirus outbreak. Those IVD policy developments lead off this week’s Pathways’ Picks.
Top Picks: IVD Activity
Diagnosing coronavirus. The need to monitor the escalating infectious disease outbreak in China, which has touched down with isolated cases elsewhere in Europe, Asia, and the US, is raising the focus on diagnostics that can detect the 2019 Novel Coronavirus. In the US, the Centers for Disease Control and Prevention is reportedly working with the FDA on a lab test, and FDA is urging companies who might be developing assays to come forward. But FDA can’t employ its Emergency Use Authorization authority until the Department of Health and Human Services makes an EUA Declaration for the coronavirus, which it has yet to do. Meanwhile, China’s National Medical Products Administration says it has approved six nucleic acid-based assays from six companies targeting the new coronavirus under its Emergency Approval Process for Medical Devices. As part of that program, NMPA has directed provincial regulators to conduct enhanced inspection activities of the companies’ manufacturing facilities. At least one company that says it has deployed test kits in China is BGI Group. Meanwhile, former FDA Commissioner Scott Gottlieb penned an editorial underscoring the potential need for rapid point-of-care tests than can be performed in a doctor’s office, rather than having to send a sample to a lab.
Medicare addresses NGS mix-up. CMS issued a coverage reconsideration decision January 27 that seeks to address gaps and confusions in prior NGS policy releases from the agency. It ensures national coverage for FDA-approved NGS tests used for patients at any stage of breast and ovarian cancer, but it also clarifies that Medicare administrative contractors (MACs) can determine coverage for use of non-approved germline tests for any inherited cancers. In March 2018, CMS issued a policy securing national coverage for NGS to inform drug therapy decisions in patients with advanced non-inherited cancers. But in the process of implementing that policy, CMS, seemingly inadvertently, cut off the previous flexibility that regional MACs had to cover other NGS applications—in particular, for germline testing for early-stage inherited cancers. The new policy responds to that issue, and improves upon a proposal released in October.“It was not CMS’ intent to restrict or remove coverage,” the final decision memo states. “CMS’ intent was to expand coverage.” For more details, check out the recent post in in the MedTech Strategist Community Blog.
Policy-making Meetings
EU MDR-year agenda. The full European Medical Device Coordination Group (MDCG) plans to meet five times in 2020, including on May 26, the date the new Medical Device Regulation officially kicks in. MCDG is the main policy-making body under the MDR, and its meetings are usually the occasion for official policy sign-offs to go through. The full breadth of policy making that is still needed in the lead up to MDR and after it takes effect is illustrated in the 2020 meeting schedule posted in recent days. Subgroups addressing topics ranging from notified body oversight, to new technologies, to post-market surveillance and unique device identifiers have dates set up throughout the year.
Communicating on safety comms. FDA has set an April 1 meeting date to discuss its practices for producing and distributing medical device safety communications. The meeting “is not intended to inform the criteria for when FDA would issue a communication,” the agency clarifies. Official FDA device safety communications used to be few and far between, but now the agency averages about 15-20 per year. The increase aligns with agency’s growing emphasis on identifying early safety signals and with its recent reorganization to bring post-market and pre-market device experts in the same office.
More to Watch
GE cyber alert. FDA issued its latest safety communication January 23, addressing an increasingly common topic of such alerts: cybersecurity. The agency said vulnerabilities have been discovered in certain GE Healthcare clinical information central stations (CARESCAPE and CIC Pro) and telemetry servers (ApexPro and CARESCAPE). An attacker may be able to remotely take control of the medical device and to silence alarms, generate false alarms, and interfere with alarms of patient monitors connected to these devices, FDA says. GE is issuing a software patch.
Experiential learning. FDA opened its latest request for companies and the healthcare community to volunteer to host agency staff for a training visit as part of its “Experiential Learning Program.” The visits are intended as a collaborative approach to filling FDA’s knowledge gaps, and not as a compliance or inspection activity. Some areas of high training interest for FDA are biocompatibility measurements, AI/machine learning, broad-based view of device innovation and development, and scope reprocessing, among others. Proposals are due February 24.
EU environmental focus. While the new medical device and IVD regulations remain the top-line focus for MedTech Europe, the device trade group expects to increasingly wade into debates over European environmental regulations in the next several years, according to Oliver Bisazza, the group’s director of regulations and policy. “The Green Deal of the European Commission is one of the key pillars that President [Ursula] von der Leyen made when being elected,” Bisazza said on the first episode of the association’s MedTech ON AIR podcast. “We do predict a growing attention and activity in that particular space because it is part of the EU agenda over the next five years.”
Aussie reg science. Australia’s Health Products Regulation Group circulated its 2020-2025 Regulatory Science Strategy to help to support oversight of next-generation technologies like health software, 3D printing, and gene therapies.
Guides and Recs
UK clinical guide. The Medicines and Healthcare products Regulatory Agency updated its guidance on medical device clinical investigations January 24 to provide more details on a company’s decisions as to whether or not a clinical investigation is required.
NICE stands behind digital health. The UK’s National Institute for Health and Care Excellence delivered a draft recommendation supporting use of digital apps, wearable devices, and online programs as supportive, though not standalone, tools to address health goals including increasing exercise, managing weight, or reducing smoking, alcohol, or unsafe sexual behavior. Comments are due March 6.
EU combinations. The European Medicines Agency recently revised its guidelines on procedures for a notified body to consult with the EMA on the conformity assessment for a device that includes an “ancillary” medical substance or human blood derivative. The updates are intended to align with the new Medical Device Regulation.
Surgical tube guidance. A draft guidance outlining 510(k) requirements for arthroscopy pump tubing sets intended for multiple patient used was posted by FDA January 27. Public comments are due March 30.
Dates to Remember
February 3. PMAs must be filed to FDA for all automated external defibrillator accessories or the products must be removed from the market by February 3, 2021.
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