eNews September 1, 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.

Anti-kickback law update delayed for one year

The much-anticipated final rule updating physician self-referral and anti-kickback laws has been pushed back one year, to Aug. 31, 2021, reports HealthLeaders. The news was a disappointment for the American Hospital Association, which has complained that the Stark Law prohibiting physician self-referrals is a hindrance in the transition to value-based care. The proposal would permit physicians and other providers to try value-based solutions without fear that their efforts to coordinate care might violate the law, according to the Centers for Medicare & Medicaid Services. The new exceptions would apply for Medicare and non-Medicare populations alike.

Quick reimbursement for ‘breakthrough’ devices

Medicare beneficiaries would get quick access to the latest medical technology under a proposed rule from the Centers for Medicare & Medicaid Services. The Medicare Coverage of Innovative Technology rule would eliminate the lag time between FDA approval of a “breakthrough” device and its approval for Medicare coverage. Under the proposal, Medicare would provide national coverage simultaneously with FDA approval for four years, after which CMS would evaluate the clinical and real-world evidence of improvement in health outcomes. Public comments on the proposed rule will be accepted until Nov. 2, 2020.

‘Home-grown’ financial hits

Health systems are looking to drive up revenue any way they can, including licensing their intellectual property, reports HealthLeaders. Michael Dixon, PhD, the current CEO of UNeMed (a for-profit subsidiary of Nebraska Medicine in Omaha), identified two home-grown “financial hits.” The first are LeVeen™ Needle Electrodes, which use radiofrequency ablation for solid tumors. Developed by a faculty member at the medical center, the technology is now licensed to Boston Scientific. The second is a startup company called Virtual Incision Corporation, which is developing a miniaturized surgical robot, focusing first on colon resection. Based in Lincoln, Nebraska, the company has raised about $50 million.

R&D spigot still on

For the third straight year, the growth rate of medical and health R&D investment outpaced the growth rate of overall health spending, reports Fierce Biotech. Research America reports that in 2018, total U.S. medical and health R&D investment was $194.2 billion. Of that: industry invested $129.5 billion, federal agencies invested $43 billion, academic and research institutions invested $15.7, foundations invested $2.3 billion, state and local governments invested $2.1 billion, and voluntary health associations and professional societies invested $1.5 billion.

Nitric oxide for pregnant COVID-19 patients

Inhaled nitric oxide gas could be a valuable adjunct respiratory therapy for pregnant women with severe and critical COVID-19, according to a study by Harvard Medical School researchers based at Massachusetts General Hospital. The delivery of NO to six pregnant patients with COVID-19 admitted to Mass General, as described in a paper published Aug. 26 in “Obstetrics & Gynecology,” resulted in a rapid and sustained improvement in cardiopulmonary function and decreased inflammation. The resolution of viral infection within 22 days was observed in five of the six patients. Three of the six women delivered four babies, including a set of twins, while in the hospital. Each infant tested negative for COVID-19 and remained in good condition 28 days after maternal admission.