CDRH Priorities for 2021 and Strategies for Digital Health Companies
MDUFA V will largely be negotiated with industry in 2021. Shuren said his hope is to “not stay focused on the more traditional things … like performance goals around premarket review. Let’s instead think about where we want the ecosystem to be at the end of MDUFA V.” Shuren said that CDRH will begin testing a system that would allow companies to track the progress of their submissions using a FedEx-style tracker. “We’re going to start in January with more of a soft-launch with a handful of developers,” Shuren said, noting that a full launch could take place next spring. Shuren teased a number of actions the center is hoping to take next year, including finalizing guidance on clinical decision support software and patient-reported outcomes, expanding its Case for Quality voluntary improvement program and developing an action plan and draft guidance on artificial intelligence and machine learning. Shuren also said that proposed rules for aligning US quality system regulations more closely with the international quality system standard ISO 13485:2016 and over-the-counter hearing aids that were delayed this year are a high priority for the center and may see the light of day in 2021.
In this opinion article, the author highlights important points digital health companies should consider when determining their commercialization regulatory strategy in 2021. COVID-19 has created an immense backlog of submission reviews particularly in 3 offices: OHT1 (responsible for anesthesia and respiratory devices), OHT4 (responsible for personal protective equipment, including N95 respirators, facemasks and decontamination systems) and OHT7 (responsible for COVID-19 tests). These offices are no longer accepting pre-submission meetings with companies meaning that if you proceed with the submission, you will need to proceed in the dark without FDA feedback on your planned approach. Other offices are also affected as resources are shifted to attend to OHT1, 4, and 7 backlogs. If possible, the author recommends digital health companies limiting themselves to unregulated or submission-exempt claims to prevent expensive commercialization delays.
FDA revised its guidance on meetings and user fee applications for medical devices during the COVID-19 pandemic to give device sponsors more time to submit responses to the agency for applications or submissions that are on hold. The guidance, initially released in June, was also updated to note that it can hold advisory committee meetings virtually, something the agency was still reviewing the feasibility of at the time the guidance was issued.
RAPS- Dec 23, 2020
An updated guidance from the FDA clarifies how the agency is handling device shortages and cessation in manufacturing during the public health emergency of the COVID-19 pandemic. The FDA’s Center for Devices and Radiological Health updated the guidance, entitled “Notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act During the COVID-19 Public Health Emergency,” so that the agency can have the information it needs to prevent or mitigate shortages. In the updated guidance, FDA clarifies what factors it uses to determine whether a device is in shortage.
RAPS- Dec 4, 2020
FDA has released three device-specific guidance documents detailing performance criteria in support of its Safety and Performance Based Pathway. The texts cover magnetic resonance (MR) receive-only coils, spinal plating systems and non-spinal metallic bone screws. FDA describes testing performance criteria companies can use to evaluate their devices, rather than relying on predicate products as is typical in 510(k) filings. The guidance details different types of mechanical testing companies can use to evaluate devices, as well as accepted approaches to the evaluation of biocompatibility and the validation of sterilization and reprocessing.
FDA released a clarified guidance on how manufacturers should utilize the ISO 10993 standard for biological evaluations of medical devices. Notably, the guidance contains an updated FDA-modified matrix to identify and determine biocompatibility endpoints for evaluations of devices and manufacturer considerations when device labels include claims that a device is free (“-Free”) of a particular substance. (EMERGO- 9/15/20)
Digital health adoption has accelerated as a result of COVID-19, with many tools and devices demonstrating value in improving patient care. However, the slower pace of change in regulatory and reimbursement pathways have left this new category of innovative approaches outside the standard processes. The Food and Drug Administration (FDA) has taken several steps to advance digital health technologies, starting with the Digital Health Action Plan, which went into effect in 2017 and has led to clarification around software as/in a medical device as well as delineating which products are subject to regulation. Reimbursement still presents a significant hurdle as the Medicare statute does not address digital health technologies within the program’s benefit categories. While traditional Medicare is still deciding how to handle digital technologies, value-based payments, managed care organizations and Medicare Advantage plans do provide a potential clinical pathway for digital health tools to be adopted more broadly.
(Journal of Clinical Pathways, December 2020)
The Centers for Medicare and Medicaid Services (CMS) stated that the intention of this new rule is to reduce administrative burden and improve patient experience. Prior authorization is the process of requesting approval from insurers before a medical service is provided. In effort to make this process more seamless, CMS is proposing to require that participating payers build and implement application programming interfaces (APIs) that meet the Fast Healthcare Interoperability Resources standards (FHIR). These FHIR-enabled APIs would help to support data exchange, reducing the waiting time and increasing transparency in the case of denials.
(CMS Newsroom 12/10/20)
Germany passed digital health legislation towards the end of 2019. The COVID-19 pandemic brought the topic to the forefront and the timing of the legislation positioned Germany as a model of digital heath technology adoption for other countries. Five apps have already been added to a registry of software that can be prescribed by physicians and reimbursed by the national health insurance program. The criteria that the apps must meet in order to be eligible for the registry include regulatory standards, evidence of efficacy, information security, and interoperability. The US, UK, and other European healthcare markets are carefully observing the outcomes of this German initiative as they begin to add legislation around digital health tools.
(Harvard Business Review 12/2/20)
Physical and Occupational Therapists as well as Speech Language Pathologists are raising concerns over sharp cuts to Medicare reimbursements in 2021. The recently announced cuts would reduce payments by about 9% in a field that already operates on very thin margins. Senior living facilities are most likely to be impacted by these cuts, which were made in effort to balance the care budget in light of the expenses from COVID-19. The Social Security Act includes a budget neutrality provision that requires off-sets such as these. Therapy providers argue that the aftermath of the virus is an especially pivotal time to deliver services to older adults since pandemic restrictions have potentially limited their access to exercise opportunities and resulted in reduced functional levels and increased risk of falls and other mobility-related incidences.
(Senior Housing News 12/14/20)
The Centers for Medicare and Medicaid Services (CMS) added approximately 60 new telehealth codes for permanent coverage to begin in 2021. New temporary codes were also added that will be covered throughout the COVID-19 public health emergency. Remote patient monitoring expansions were finalized, continuing the ability for physicians to provide services to established patients using FDA approved medical devices.
(mHealth Intelligence 12/2/20)
The Simbex Regulatory and Reimbursement Recap is a monthly briefing for news in the regulatory and healthcare reimbursement space relevant to Simbex areas of expertise. The briefing is curated by Amaris Ajamil, PhD, RAC, Simbex Senior Quality Assurance/Regulatory Engineer, Angela Smalley, PhD, Simbex Centers Project Leader, Project Evaluation, and Mohammed Kazi, MS, Simbex Quality Systems Coordinator. A story’s inclusion does not imply endorsement by Simbex.