IMDA eNews 021423

The latest news affecting you and your customers…

from the Independent Medical Specialty Dealers Association

Bill would boost ambulatory surgery centers

The Ambulatory Surgery Center Association (ASCA) announced its support for the reintroduction of the Outpatient Surgery Quality and Access Act of 2023. The legislation seeks to increase Medicare patients’ access to ambulatory surgery centers, ensure adequate reimbursement, and provide better quality metrics across sites of care. Included in the legislation are provisions to: 1) require the Centers for Medicare & Medicaid Services to publish relevant quality data in a way that allows patients to compare quality across sites of service; 2) eliminate the copay penalty Medicare beneficiaries pay for certain Part B services provided in an ASC; and 3) provide transparency regarding the criteria CMS uses to exclude procedures from the ASC Covered Procedures List.

A thousand bucks for acting healthy

UnitedHealthcare has introduced a rewards program in which eligible members, including spouses, can use wearable devices to earn up to $1,000 each per year by completing various daily health goals and one-time activities. One of the ways members can earn rewards is by using a compatible activity tracker, smartwatch or smartphone to meet daily activity goals, and track sleep and other health-related activities. The financial rewards can either be added to a prepaid debit card or deposited into a health savings account.  

Clinical-decision tools to be regulated as medical devices

The FDA may wield a heavier hand in regulating clinical-decision support tools, such as those that flag potential cases of sepsis, medication interactions and care reminders, reports MedTech Dive. Under the 21st Century Cures Act, some of these systems had been exempted from FDA regulation if healthcare providers could independently review the basis of the recommendations, and if providers didn’t rely on them to make a diagnostic or treatment decision. But under final guidance issued in September, the FDA ruled that more predictive tools would now be regulated as medical devices. Reactions were mixed. Some companies welcomed the clarity, including Bayesian Health, which makes sepsis detection software, and Mayo Clinic, which is developing algorithms to detect heart conditions using ECG data. But others, including the Clinical Decision Support Coalition, said the guidance could dissuade innovators from developing these tools.


Imaging applications lead all other AI medical algorithms

Most of the 520 marker-cleared artificial intelligence (AI) medical algorithms available in the United States are related to medical imaging. With 396 cleared algorithms, radiology leads the pack; cardiology is second, with 58; and  hematology is a distant third with 14, reports HealthExec. The first AI algorithm was cleared by the FDA in 1995, and fewer than 50 algorithms were approved over the next 18 years. However, the numbers have increased rapidly in the past decade, and more than half of algorithms on the U.S. market were cleared between 2019 and 2022. Last October, the FDA approved 178 new AI and machine learning (ML) systems, which are intended to derive new insights from data generated during the delivery of healthcare every day.

Cardiology care becoming team-based

Over the past decade, more and more cardiology patients have been treated by a multidisciplinary heart team, according to Cardiovascular Business. The concept was originally created to select which patients were best suited for transcatheter aortic valve replacement (TAVR) or open -heart valve replacement surgery to help eliminate biases between surgeons and interventional cardiologists. These teams often include a cardiac imager, a nurse and a patient navigator at a minimum. They discuss the patient’s health and possible next steps, similar to a tumor board. The team also pre-plans the case and work together during the live case.