Medicare rules on coverage of innovative technology pushed back

The Centers for Medicare and Medicaid Services (CMS) adopted a final rule on Medicare coverage for innovative technology (MCIT) on January 14, 2021. On March 17, 2021, CMS delayed the effective date of the rule until May 15, 2021 to additional time for public comment.

The MCIT rule established a pathway to Medicare coverage for medical devices designated as breakthrough by the Food and Drug Administration (FDA). However, the rule did not address operational issues, such as how CMS would establish coding and payment levels for breakthrough devices. CMS noted that according to a recent report by the FDA, more than 400 devices have been designated as breakthrough – a much larger volume than anticipated at the time that the proposed rule for MCIT was published. Also, recent expert comments have raised concerns about how breakthrough technology may affect older patients specifically. The additional comment period will provide opportunity for comment on how to assess clinical benefit to the Medicare population.

FDA issues report on patient safety impacts of non-device software

The Food and Drug Administration (FDA) is the federal agency responsible for regulating drugs and medical devices. Due to the pace of digital health innovation in recent years, more questions have arisen about when information technology constitutes a medical device, subject to FDA clearance. The 21st Century Cures Act excluded five types of software from the definition of “device” under the Federal Food, Drug and Cosmetic Act. While these software functions do not require FDA approval as a medical device, the Cures Act requires the FDA to report every two years on risks and benefits to health and patient safety arising from development of these types of software. The most recent FDA report was issued in late November 2020. The report highlights usability issues in electronic health records (EHRs) and administrative software, and safety vulnerabilities in clinical decision support software within EHRs. On the positive side, several recent studies have reported good results for health promotion and wellness digital apps and wearable technology.

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FDA Digital Health Center of Excellence Hosts First Listening Session

The Food and Drug Administration (FDA) Digital Health Center of Excellence (DHCoE) held its first listening session with digital health stakeholders on October 19, 2020. Bakul Patel, Director of the DHCoE, stated that advancements in digital health are moving health care from the clinic to the patient. It is essential that innovators in digital health understand patient behavior and focus on wellness and prevention.

A panel of stakeholders urged regulatory clarity for innovations in digital health and adoption of international standards. In particular, the FDA should ensure consistency of approach across divisions of the agency. The industry needs insight into when FDA clearance is required for digital health tools, and when it is not required, and there should be well-defined regulatory pathways. Speakers noted that developers in consumer technology may not be used to dealing with the FDA and will need education on agency processes.

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