eNews October 27, 2020

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.

FDA tries to ease oversight of digital technologies

The FDA’s new Digital Health Center of Excellence will become a “one-stop” resource for developers of digital technologies, including AI/machine learning, software as a medical device, and wearables, the Center’s leader, Bakul Patel, said during an Oct. 19 webinar. The FDA wants to provide the “least burdensome” oversight based on “efficient, transparent, and predictable product review” with consistent evaluation quality, Patel was quoted as saying by MedTech Dive. “We want to continue to provide clarity on regulation,” he said, with strong strategic partnerships with industry “to make sure that this field collectively gets to the next level.”

Telehealth is a top priority for providers

Virtual care is a top priority of U.S. healthcare executives, according to a survey by the Center for Connected Medicine, reports Fierce Healthcare. Prior to COVID-19, tight regulations and low reimbursement impeded implementation of telehealth. But when the pandemic occurred, leaders experienced rapid progress as regulations were loosened and reimbursement was increased. Although some data shows that telehealth visits are beginning to drop as patients return to their doctors’ offices, most health system executives look forward to improving integration, infrastructure, and security for an updated telehealth strategy.

Great innovation! But is it covered by Medicare?

Medical device innovators seek two things in life: 1) FDA clearance and 2) CMS reimbursement. The Medical Device Innovation Consortium has appointed Jo Carol Hiatt, M.D., MBA, to help medical companies better understand the evidence they will need to support efficient CMS review. Prior to MDIC, Hiatt led teams reviewing new technologies for Kaiser Permanente. Founded in 2012, the Medical Device Innovation Consortium is a public-private partnership created to advance medical device regulatory science throughout the total product life cycle.

Ambulatory surgery centers get boost

The Centers for Medicare & Medicaid Services is proposing to eliminate its inpatient-only (IPO) procedure list over three years, starting with 266 musculoskeletal procedures, setting the stage for moving more procedures to ambulatory surgery centers, reports HealthLeaders Media. (The IPO list is a list of procedures Medicare considers appropriate for inpatient admission regardless of length of stay.) Under the proposal, providers wouldn’t be forced to perform these procedures on an outpatient basis, but they would be allowed to shift them to the outpatient setting for clinically appropriate patients. CMS has previously stated they do not expect large volume shifts when procedures are removed from the IPO list, but past experience with total knee and hip arthroplasty has shown big swings in volume for some facilities.

Prop 22 puts spotlight on contractor-vs-employee debate

Top executives of Uber, Lyft and DoorDash are spending lavishly to convince California voters to vote “Yes” to Proposition 22, which would exempt them and other “gig companies” from complying with a law forcing them to treat gig workers as employees, reports The New York Times. Uber and its peers fear that the state labor law, which went into effect at the beginning of the year, will send them into a downward financial spiral by forcing them to offer benefits to their workers, including unemployment insurance and healthcare.

Materials managers elect new board members

The AHA’s Association for Health Care Resource & Materials Management – AHRMM – elected Jimmy Chung, M.D., associate vice president, perioperative portfolio at Providence St. Joseph Health, as chair-elect of its 2021 board. AHRMM members also elected as provider representatives on the board: Amanda Chawla, vice president of supply chain for Stanford Hospital, Stanford Children’s Health and Stanford-Valley Care; Lori Pilla, system vice president and chief supply chain officer at Mercy Health; and Curtis Lancaster, vice president of supply chain at Dartmouth-Hitchcock Medical Center. Randy Bradley, executive vice president of digital transformation for life sciences at Bio Supply Management Alliance, was elected an affiliate representative on the board.