Breakthrough cancer detection device gets parallel FDA, CMS review

A breakthrough cancer in vitro diagnostic (IVD) device that uses next generation sequencing (NGS) to detect genetic mutations in solid tumors took only six months from product application to FDA approval and a preliminary national coverage determination (NCD) from CMS, thanks to the Parallel Review program. Foundation Medicine’s FoundationOne® CDx™ (F1CDx) received simultaneous overlapping review by the FDA and CMS, which reduces the time necessary to marketing and coverage of innovative medical devices.

The Parallel Review program for medical devices was fully implemented in October 2016 following a pilot program (see Parallel Review program will be fully implemented and extended indefinitely, Health Law Daily, October 24, 2016). Ordinarily, CMS does not begin the NCD decision-making process until after a device has been approved or cleared for marketing by the FDA, which results in a longer wait before Medicare beneficiaries can access the device. Through Parallel Review, manufacturers receive feedback from both agencies through the clinical trial design stage, which helps them to design trials that fulfill evidentiary requirements for both steps of the process, potentially eliminating the need for additional trials.

Although the F1CDx device is a laboratory-developed test and therefore generally would not require premarket review from the FDA, Foundation Medicine requested Breakthrough Device designation for the test. The 21st Century Cures Act (P.L. 114-255) expanded the Expedited Access Pathways (EAP) program to breakthrough technologies that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions (see Will the Cures Act address what ails the FDA approval process?, Health Law Daily, March 9, 2017). The FDA granted that designation because the F1CDx test has “potential to consolidate multiple companion diagnostic claims for patients and health care providers into a single test.”

Hospital compliance programs need to integrate explanted device policy

Medicare requires that explanted medical devices—implantable devices that are removed due to recall, advisory, malfunction, failure, or early battery depletion—must be pursued by the provider as for free replacement or reduced charges under warranty. The failure to do so results in an overpayment for the provider or hospital, which must then be repaid to CMS. In a Health Care Compliance Association (HCCA) webinar, Jesse Schafer, Explant Control Manager, Mayo Clinic, and Peter Casady, CEO and Co-Founder, Champion Healthcare Technologies discussed best practices for medical device warranty credit failures and related HHS Office of Inspector General (OIG) audits.

Since 2010, the OIG has conducted six audits specifically for credit failures on medical device warranties, and found overpayments ranging between $30,000 and $300,000. In these cases, the warranty credit failures occurred because the hospitals:

  • did not pursue available credits;
  • did not report credits received;
  • did not have adequate internal control procedures to coordinate functions among various departments; or
  • relied upon the vendor to manage the device return and credit process (and gaps resulted).

Schafer recommended a workflow among various departments, including compliance, coding, clinical, pathology, supply chain / contracting logistics, accounts receivable, and patient financial services. Hospitals should (1) identify explanted devices that are eligible for warranty credits due to performance issues; (2) secure eligible explanted devices; (3) make sure the devices were returned to the vendor for warranty claims; (4) follow up on warranty claims to confirm approval; (5) make sure the provider then received credit or a no-charge replacement; and (6) adjust claims for credits that are greater or equal to 50 percent.

Medical device stakeholders give House feedback on 4 separate bills

A variety of stakeholders in the medical device industry testified before the House Energy and Commerce Committee with respect to a number of bills related to devices, including the Over-the-Counter Hearing Aid Act (H.R.1652), the Medical Device Servicing Safety and Accountability Act (H.R. 2118), the Fostering Innovation in Medical Imaging Act of 2017 (H.R. 2009), and a bill to amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device establishments and for granting export certifications (H.R. 1736), which would enhance the authorization Medical Device User Fee Amendments (MDUFA IV). While stakeholders took opposing viewpoints with respect to some bills, those that spoke to MDUFA IV, including Director of the FDA’s Center for Devices and Radiological Health Jeffrey Shuren, all expressed their support.

Over-the-Counter Hearing Aid Act

The Over-the-Counter (OTC) Hearing Aid Act would permit the sale of OTC hearing aids for use in adults with mild to moderate hearing impairments. Speaking on behalf of the Hearing Industries Association (HIA), Dr. Thomas Powers of Powers Consulting, LLC supported the sales of OTC hearing aids for mild hearing impairments, but opposed the provision of such hearing aids for moderate use. Hearing impairment, particularly moderate and severe impairments, are complex and, in Powers’ opinion require consultation and fitting with hearing health professionals; in addition, he cited to a study indicating that hearing impaired individuals were more likely to be satisfied and wear hearing aids fitted by a professional.

Frank R. Lin, M.D., Ph.D., Associate Professor in the Departments of Otolaryngology-Head & Neck Surgery and Geriatric Medicine at the John Hopkins School of Medicine and in the Departments of Epidemiology and Mental Health at the Johns Hopkins Bloomberg School of Public Health, on the other hand, opined that OTC sales would make hearing aids more accessible and affordable to the hearing-impaired population; currently, less than 28 percent of the nearly 38 million Americans with significant hearing loss have access to the devices. He argued that alleged safety concerns about the sale of OTC hearing aids to individuals with moderate hearing loss were raised by parties looking to preserve the status quo, which offers little incentive for innovation of new market entry, with, “98 percent of the world’s hearing aid marketplace being controlled by six companies.” He likened the risks of OTC hearing aids to the risk of OTC reading glasses or aspirin.

Medical Device Servicing Safety and Accountability Act

H.R. 2118 would require establishments that service medical devices to register with the FDA, establish a complaint-handling system, and report adverse events to the agency. Joe Robinson, Senior Vice President of Health Systems Solutions for Philips North America, offered his support of the bill on behalf of the Medical Imaging & Technology Alliance (MITA). He noted that improper servicing of medical devices by non-manufacturer entities can injure patients via direct or indirect bodily harm, and can also cause problems for manufacturers down the road. For example, the manufacturer may not be aware of adverse events or may not be familiar with the chain of events that ultimately led to an adverse event, may experience difficulty upgrading parts that have been altered by a third party, or may have its device certification voided. MITA believes that registration and complaint handling is an important first step to improve service and safety.

Robert J. Kerwin, General Counsel for the International Association of Medical Equipment Remarketers and Services, Inc. (IAMERS), adamantly opposed the bill. He argued that the legislation provided a solution for a problem that does not exist, noting that, of the 177 public comments submitted to the FDA in response to its request for comments, including comments on service regulation, nearly none of them made negative comments about third-party device services, and that The Joint Commission, in its comment, stated that it “has no knowledge of any statistically significant level of safety problems resulting from the activities of any kind of maintenance/service provider.” Kerwin contrasted MITA’s opinion that increased regulation is necessary to prevent improper servicing with its members’ decisions to subcontract with IAMERS members to perform repair work. He further emphasized that the language of the bill would classify any type of repair work performed as a complaint, increasing the burden on third-party services, and hurt rural and regional hospitals that rely heavily on third-party servicers.

Fostering Innovation in Medical Imaging Act 

H.R. 2009 would “provide clarity with respect to the regulation of diagnostic imaging devices intended for use with contrast agents.” Currently, the FDA will not approve imaging devices or enhancements for use with approved contrast agents, if the agents are not specifically labeled for that use. MITA approved of the bill’s provision of “a clear regulatory pathway” to promote innovation.

H.R. 1736

Patricia Shrader, Vice President for Global Regulatory Affairs at Medtronic, Inc., spoke on behalf of AdvaMed, the Advanced Medical Technology Association, to offer its support of the bill, which would establish a risk-based inspection schedule based on a medical device facility’s risk profile. Shrader opined that this would allow the FDA to consider a facility’s compliance history and other related factors in scheduling inspections, as opposed to aligning the frequency of inspections with the classification of the devices a facility manufactures. She applauded the bill’s plan to improve FDA and facility communications prior to, during, and after inspections, noting that facilities would no longer need to wonder from day-to-day, during the course of an ongoing inspection, whether an inspector would be able to travel to the facility. The bill would also require the FDA to provide non-binding feedback on proposed remediation plans, so that facilities are not left wondering what changes they should make. Finally, the bill would require the FDA to implement a process to address refused international device certifications—certificates to foreign governments (CFGs)—when those refusals result from lack of FDA confirmation, rather than issues with the devices.

False promises rebuked by FDA, no tea or vitamin can cure cancer

Bogus cancer “treatments” being marketing and sold without FDA approval were the target of 14 warning letters and four online advisory letters, according to a press release and consumer update from the agency. The 65-plus products listed by the agency include pills, tablets, creams, syrups, sprays, oils, salves, teas, and medical devices, claiming to cure cancer in humans and pets, and have been found illegally for sale online, in retail stores, at flea markets and swap meets, and even at trade shows.

The FDA called these illegal products a “cruel deception,” and urged consumers to stay away from products that have not passed the agency’s review process, designed to ensure the safety and effectiveness of treatments. It listed the following phases or concepts as warning signs that the advertised product was unlikely to be approved by the agency:

  • treats all forms of cancer;
  • miraculously kills cancer cells and tumors;
  • shrinks malignant tumors;
  • selectively kills cancer cells;
  • more effective than chemotherapy;
  • attacks cancer cells, leaving healthy cells intact; or
  • cures cancer.

Additionally, many of the products that were the subject of the warnings were advertised as “natural” or “non-toxic.”

The warning and advisory letters ask the recipient companies to provide written responses to the violations covered in the letters; if the companies fail to respond and make adequate corrections, they could be subject to further actions including criminal prosecution. According to the FDA, the best scenario for consumers who have purchased or used these products is ineffectiveness. It is possible, however, that these products could interfere with proven, beneficial treatments, or even cause direct harm.