FDA clarifies definition of devices vs. counterfeit devices and 2023 CMS fee schedule includes updates to RTM codes
FDA has published draft guidance updating its definition of a device in accordance with the 2021 Safeguarding Therapeutics Act. The document is intended to delineate devices from counterfeit devices, but does not include enforcement discretion for counterfeit devices. The new definitions give the FDA authority to destroy counterfeit devices; however, the agency noted that a separate rulemaking process is required.
On November 28, the Swiss Parliament National Council voted to adapt its national laws, allowing Switzerland to accept medical devices with FDA approval. The country’s Federal Council will adapt national laws so that, in addition to medical devices with an EU certificate /CE mark, medical devices with U.S. FDA approval will also be recognized in Switzerland. In addition to challenges brought by new EU MDR, Switzerland has struggled to approve and introduce new devices due to its revised national medical device ordinance, which created even tougher import hurdles. Swiss Medtech reports that more than 1,000 of the approximately 5,000 foreign manufacturers have already stopped supplying Switzerland with their products.
(MedTech Intelligence 11/29/22)
FDA announced a Class I recall, the most serious type of recall, for Baxter International’s Incontinence Management System due to risk of radiofrequency (RF) interference with nearby medical equipment. The company is recalling the system after receiving reports that the RF from WatchCare devices may interfere with other medical devices, including equipment critical to the health and wellbeing of patients. Affected devices include infusion pumps, insulin pumps, blood glucose sensors, fetal monitors/dopplers, telemetry devices, and bladder scanners. Baxter reported that the RF interference from the system may cause erroneous readings or malfunctions of these other devices on both patients and staff, which could lead to inappropriate medical treatment or no treatment when needed. If the RF emissions affect a medically necessary device like a blood glucose sensor or fetal monitor, the issue could lead to serious injury or death, leading to why the administration classified the recall as Class I.The company reported 96 complaints of interference and, to date, all interference cases but two occurred at distances less than one meter. There have been no reports of serious injuries or deaths related to the issue.
(MDDI Online 11/28/22)
The use of remote regulatory assessments (RRAs) has helped the US Food and Drug Administration (FDA) identify “significantly deficient” good manufacturing practice (GMP) violations when officials cannot visit sites. Yet the program does pose some technical and logistical challenges, which can interfere with a manufacturer’s ability to respond to requests for records. RRAs may include a request for records or interactive evaluations of an FDA-regulated establishments, can incorporate the use of livestreaming video, and can be voluntary or mandatory. FDA has used records requests for 600 surveillance inspections and 300 preapproval inspections (PAIs), out of which 30% of PAIs are denied. The agency has issued 30 import alerts following RRAs.
A new survey from the European Commission shows that many medical device and in vitro diagnostic (IVD) manufacturers have yet to apply for certification under the Medical Devices Regulation (MDR) or In Vitro Diagnostic Medical Devices Regulation (IVDR), despite pending expirations of their CE Marking under previous Directives. The MDCG has previously issued recommendations for medical device manufacturers to secure MDR compliance in order to avoid decertification and ultimately a potential device supply shortage in Europe, but the new survey results provide significant data highlighting compliance challenges.
EU regulations require manufacturers without a presence in a member state to appoint a sole authorized representative who serves as their EU contact person and is central to ensuring compliance. MDR and IVDR outline the obligations of authorized representatives and enhance their responsibilities. “The manufacturer and the authorized representative are free to configure the structure of their contractual relationship as they see appropriate, as long as there is a written mandate that meets the minimum requirements of Article 11(3) of the Regulations and the content of which is agreed between the parties. A mandate should be drawn up irrespective of whether the authorized representative is independent/outside of or is part of the same larger organization as the manufacturer,” according to the guidance. Article 11(3) requires the authorized representative to perform tasks specified in their mandate with the manufacturer. Upon request, the authorized representative must provide a copy of the mandate to the competent authority. The article also describes the minimum tasks that the mandate should cover, but the authorized representative can agree to take on additional activities.
The remote therapeutic monitoring (RTM) code set was first added to the Centers for Medicare and Medicaid (CMS) fee schedule in 2022. The revisions include some clarifications due to popular demand. One of the most important changes was the declaration that general supervision can be used for all of RTM. Some changes that CMS declined to implement were to eliminate the 16-day data collection requirement and to introduce a generic supply of device code. CMS did offer detailed explanations of their logic behind these decisions. Another new addition was CPT code 989X6: supply of device for cognitive behavioral therapy monitoring. This new code was not assigned a national fee amount, and will be priced by the individual MACs for the time being.
(NixonGwiltLaw.com Blog, 11/7/22)
ReWalk is a wearable robotic exoskeleton that provides powered hip and knee motion to enable individuals with spinal cord injury (SCI) to stand upright, walk, turn, and climb and descend stairs. The ruling means that eligible insured people with SCI have a legal basis for the supply of an exoskeleton as an orthopedic aid for direct compensation in Germany, which is considered ReWalk’s largest market for exoskeletons. The court came to its decision based on a determination that an exoskeleton device directly compensates for the loss of abilities in people with SCI, like the ability to stand, walk, and ascend or descend stairs and curbs. Direct disability compensation applies to medical aids which replace failed or impaired bodily functions, like SCI, to the extent that the person using them is on par with people without disabilities. Of note, according to the press release announcing the ruling, the provision of an advanced technical aid, such as ReWalk, can be provided to the medically eligible insured person regardless of previously supplied medical aids.
Prominent healthcare systems are feuding with insurance companies across the country. Examples include the University of Mississippi Medical Center and Blue Cross Blue Shield (BCBS), where mediation attempts were suspended in October. The conflict has escalated to defamation lawsuits of three hospital executives that have been filed by the insurance giant. The hospital is now out of network until an agreement on payment rates can be reached. A similar situation occurred in Maryland between Johns Hopkins and BCBS. In Pennsylvania, Aetna and the Lehigh Valley Health Network are going separate ways, which will affect tens of thousands of patients across the state. These disputes are occurring as insurance companies are reporting record profits while hospital systems are struggling to keep their doors open due to profits in the red and staff shortages.
(Beckers Payer Issues, 11/21/22)
Endo-App, a digital therapeutic application for the treatment of endometriosis, has been added to Germany’s list of reimbursable prescription digital health products (DiGA). Products included in the DiGA are class I or IIa CE-marked and who have met stringent evidence requirement thresholds. The application is recommended for use for a 90-day treatment duration that includes behavioral interventions and education. The costs is reported to be €598,95.
(FemTech Insider 11/16/22)
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 Director, Quality and Regulatory, and Angela Smalley, PhD, Simbex Senior Product Consultant. A story’s inclusion does not imply endorsement by Simbex.