eNews February 16, 2021

The latest news affecting you and your customers… from the Independent Medical Specialty Dealers Association

How is COVID-19 affecting your business, your people, your customers? IMDA is a membership organization, and in times like these, we can all use some camaraderie. If you have a COVID story to share, advice to offer, or a warning to sound, send it to Mark Thill, IMDA’s communications director, at mdthill1913@gmail.com, with the subject line “IMDA COVID story.” We’ll compile them and send them back out to you.

Breakthrough devices in cardiovascular

FDA has granted breakthrough device designation to a clutch of cardiovascular disease products, reports Med Tech Dive. They include: Puzzle Medical Devices’ minimally invasive transcatheter heart pump, called ModulHeart, which is designed to enable heart failure patients to get treated without undergoing open heart surgery; Alleviant Medical, for its implant-free approach to the treatment of chronic heart failure, allowing physicians to use a transcatheter technology to decompress the left atrium in a procedure performed under fluoroscopy and ultrasound guidance; Vascular Perfusion Solutions, for its cardiac transport device, which can fit in the overhead compartment of a commercial airliner and can preserve vascularized tissue for eight hours using oxygenated perfusion; and Pedra Technology, for its real-time tissue perfusion system in the treatment of critical limb-threatening ischemia.

Speaking of breakthrough devices …

Are your manufacturer partners aware of the FDA’s Breakthrough Medical Devices program? Steer them to the agency’s FAQs on the topic. The voluntary program is for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. Its goal is to provide patients and healthcare providers timely access to these medical devices by speeding up their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization.

Accelerated Medicare coverage for innovative products

The Centers for Medicare & Medicaid Services issued a final rule on Jan. 12 creating a new, accelerated Medicare coverage pathway for innovative products that the FDA deems “breakthrough.” Under the Medicare Coverage of Innovative Technology (MCIT) rule, Medicare can provide national coverage simultaneously with FDA approval, up to a period of four years. (Currently, FDA approval of a device is followed by an often lengthy and costly process for Medicare coverage.) After the coverage period is over, CMS will re-evaluate the device based on clinical and real-world evidence of improvement in health outcomes among Medicare beneficiaries to determine more permanent coverage. CMS believes the four-year timeline may incentivize the manufacturers of these breakthrough devices to develop additional evidence regarding the applicability of their products to the Medicare population, so they might continue Medicare coverage beyond the initial four years.

Feds to give innovation a nudge

The Biden administration is planning to form a new agency – an Advanced Research Projects Agency for Health – that would pay academics and private companies to develop innovative health products and services, reports Fast Company. The agency would mimic the process of the Defense Advanced Research Projects Agency (DARPA), whose work helped create the Internet. The goal would be to advance innovation into real-world products for healthcare that could solve persistent problems, such as high drug costs, lack of treatments for rare diseases, poor systems of care, and pandemic preparedness.