CMS proposes to repeal mandated Medicare coverage of breakthrough devices

The Centers for Medicare and Medicaid Services (CMS) proposes to repeal the Medicare Coverage of Innovative Technology (MCIT) that was published on January 14, 2021, along with the definition of "reasonable and necessary" published at the same time. The effective date of these rules had previously been delayed to December 15, 2021. The proposal to repeal them will be published in the Federal Register on September 15, 2021.

Under the original MCIT rule, devices designated by the Food and Drug Administration (FDA) as breakthrough devices would be covered under Medicare for four years starting on the date that the FDA authorizes marketing of the device (or a later date if designated by the manufacturer). In proposing to repeal the MCIT rule, CMS notes that it and the FDA operate under different statutes in approving Medicare coverage by CMS, and breakthrough designation by FDA. The standard for Medicare coverage is a determination that a device is reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body part. In making national coverage determinations under this "reasonable and necessary" standard, CMS considers whether the item or service improves health outcomes for Medicare beneficiaries, who are typically older and with more comorbidities than the general population.

Under the FDA's processes for breakthrough designation, a device can be approved for this designation prior to marketing authorization. Under the Breakthrough Devices Program, medical devices and combination products must meet two criteria. First, the device must provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions relative to the current standard of care. Second, the device must satisfy one of four elements:

  • it represents a breakthrough technology;
  • no approved or cleared alternatives exist; 
  • it offers significant advantages over existing approved or cleared alternatives; or 
  • device availability is in the best interest of patients.

CMS expressed concern that since the FDA does not require that Medicare beneficiaries be included in clinical studies required for marketing authorization, evidence that the device is reasonable and necessary for the Medicare population may not exist. Also, the MCIT rule would limit CMS's ability to deny coverage if a particular device is found to be harmful to Medicare beneficiaries; CMS could remove coverage only if the FDA removed marketing authorization or issued a warning letter.

The controversial aspect of the definition of reasonable and necessary published on January 14 was the extension of the appropriateness criteria to commercial insurers. CMS proposes to repeal this rule as well, but invites comment on this aspect. CMS invites comments on how to provide improved access to innovative technologies for Medicare patients. Comments are due within 30 days after the publication of the proposed rule on September 15.

FDA approves marketing of hologram imaging system

The Food and Drug Administration (FDA) has approved the marketing of the HOLOSCOPE-i device developed by Real View Imaging Ltd. The HOLOSCOPE-i generates holograms from 3D data from CT and ultrasound sources. The hologram floats in air at hands reach from the clinician, who can directly interact with the image. It is intended to provide visual information for analysis of surgical options, and the intraoperative display of images. The FDA granted marketing approval based on a clinical study demonstrating substantial equivalence between the HOLOSCOPE-i and an existing legally marketed device, the EchoPixel True 3D Viewer. For the HOLOSCOPE-i, the 3D holographic image is displayed via an optical system, while the EchoPixel uses 3D glasses.

Australian Health Insurance Cards in Apple Wallet

The Australian Health Industry Claims and Payments Service (HICAPS) now allows healthcare practitioners to accept digital insurance cards stored in the Wallet feature on iPhones or the Apple Watch. Four Australian insurance firms participate in the program. This allows customers to make a health insurance claim by holding their iPhone or Apple Watch near a HICAPS terminal. Real-time notifications about the claim will be sent through the insurer's app. No information about the claim goes to Apple because there is a direct encrypted connection between the user's device and the HICAPS terminal.

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.

Read more ...

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.

Read more ...

View LinkedIn Profile

Shack Cookies Restrict

This website uses cookies to properly administer the site and improve your experience. Continuing to use this website indicates your acceptance. Please click "accept" to remove this message.