eNews March 4, 2020The latest news affecting you and your customers… from the Independent Medical Specialty Dealers Association
510(k)s: Easier going ahead?
Good news for manufacturers of innovative technologies: The FDA has launched a new optional 510(k) submission template, which it says will be easier and quicker for companies to complete. The template, referred to as the electronic Submission Template And Resource (eSTAR), will be released as part of an eSTAR Pilot Program. According to the FDA, with an eSTAR, the content of the premarket submission will be embedded within a PDF document, which should allow applicants “more dynamic functionality” when developing, viewing and editing a 510(k). More details here.
Soap-and-water still the best way to keep CPAPs clean
The FDA issued a Safety Communication on Feb. 27 to inform patients and healthcare providers that devices claiming to clean, disinfect or sanitize continuous positive airway pressure (CPAP) devices or accessories (such as masks, tubing, headgear) using ozone gas or ultraviolet (UV) light are not legally marketed for this use by the FDA in the U.S., and as such, their safety and effectiveness for use with CPAP devices and accessories is unknown. To ensure the safe and effective cleaning of CPAP devices and accessories, the FDA recommends that consumers and healthcare providers follow the cleaning instructions provided by the CPAP’s manufacturer, which normally include regular cleaning with soap and water.
Medicare test new EMS payment model
The Centers for Medicare & Medicaid Services (CMS) has selected 205 ambulance service providers to participate in the Emergency Triage, Treat, and Transport (ET3) Model. The five-year model will provide greater flexibility to ambulance care teams to address emergency healthcare needs of Medicare Fee-for-Service beneficiaries following a 911 call. Currently, Medicare only pays for emergency ground ambulance services when beneficiaries are transported to specific types of facilities, most often a hospital emergency department. With ET3, Medicare will also pay participating ambulance suppliers and providers to 1) transport a beneficiary to an alternative destination (such as a primary care doctor’s office or an urgent care clinic), or 2) initiate and facilitate treatment in place by a qualified healthcare practitioner, either in-person on the scene or via telehealth.
In case of shortages …
The FDA is seeking to get a jump on potential medical device shortages in emergencies, such as COVID-19. FDA lacks the same authorities for medical device shortages as it does for drugs and biological products, said Commissioner Stephen Hahn. That is to say, medical device manufacturers are not required to notify the FDA when they become aware of a circumstance that could lead to a device shortage or meaningful disruption in the supply of that device in the U.S., nor are they required to respond to inquiries from the FDA about the availability of devices. The FDA proposes to require that firms notify the agency of an anticipated meaningful interruption in the supply of an essential device; require all manufacturers of devices determined to be essential to periodically provide the FDA with information about the manufacturing capacity of their essential devices; and authorize the temporary importation of devices where the benefits of the device in mitigating a shortage outweigh the risks presented by the device that could otherwise result in denial of its importation into the U.S.
Feds block proposed health system merger
The Federal Trade Commission issued an administrative complaint and authorized an action to block the proposed merger of Jefferson Health and Albert Einstein Healthcare Network, two leading providers of inpatient general acute care hospital services and inpatient acute rehabilitation services in both Philadelphia County and Montgomery County, Pennsylvania. “The proposed merger would eliminate the robust competition between Jefferson and Einstein for inclusion in health insurance companies’ hospital networks to the detriment of patients,” according to the FTC. The American Hospital Association reports that this is the first time since 2016 that the FTC has opposed a major hospital merger. The proposed merger, announced in September 2018, would create an 18-hospital system with more than 50 outpatient and urgent care centers.