eNews Nov 16, 2021

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

CMS to slow down on ‘Breakthrough’ designations

The Centers for Medicare and Medicaid Services rescinded a proposed rule that would have granted expedited Medicare coverage for up to four years for certain Food and Drug Administration (FDA)-designated “breakthrough” devices once they receive or clear market authorization. “Although we continue to be in favor of enhancing access to new technologies, we are mindful that they may have unknown or unexpected risks and must first ensure such technologies improve health outcomes for Medicare beneficiaries,” said CMS Administrator Chiquita Brooks-LaSure.

Dibs on semiconductor chips

The ongoing shortage of semiconductor chips has greatly impacted the medical sector and is significant cause for concern, argues AdvaMed in its Nov. 8 response to the Department of Commerce’s request for comments on risks in the semiconductor supply chain. In a study commissioned by AdvaMed, Deloitte researchers reported that two-thirds of AdvaMed members have semiconductors and firmware/embedded software in over half of their products. In addition, 50 percent of AdvaMed survey respondents report that connected devices, which also require semiconductors, comprise half of their products. What’s more, the medical device industry’s primary needs are second- or third-generation chips, placing it in competition with automotive, industrial, and consumer industries for critical chips rather than high tech.

The ‘right to repair.’ Who has it?

A summertime Executive Order on promoting competition in the American economy has stirred an old debate: Who has the right to repair medical equipment – the OEM or a qualified third party? Biden’s Executive Order covered competition in the repair market, but didn’t address medical equipment. Not surprisingly, the Medical Imaging & Technology Alliance, which represents manufacturers, believes “maintaining and repairing medical device equipment raises both patient safety and cybersecurity concerns,” and should be controlled by OEMs. The advocacy group Right to Repair, on the other hand, is committed to “blocking repair monopolies for anything with a chip.”

Post-surgical blood-flow monitoring

A wearable ultrasound device allowed for continuous and accurate monitoring of blood flow, according to a study funded by the National Natural Science Foundation of China, reports Neurology Today. The device may help prevent thrombosis and restenosis complications after surgery, particularly in patients with fragile skin, according to researchers. Although thrombosis can occur within 72 hours, and patients are supposed to be checked every hour for capillary fill and skin color, these assessments might only happen sporadically in the hospital and not at all after discharge.

Coloplast buys big into laryngectomy market

Denmark-based Coloplast signed an agreement Nov. 8 to acquire Atos Medical, a Swedish firm that specializes in chronic neck stomas care. Laryngectomy is a niche chronic segment with many similarities to Coloplast’s existing chronic patient segments, i.e., ostomy care, continence care, wound and skin care, and interventional urology. “The laryngectomy market remains significantly underserved … due to patients not being served adequately with products or not being served at all,” the company said in its announcement.