The amount of auditing of RPM companies has increased in the last two years, two lawyers told Fierce Healthcare, and the audits have gotten more aggressive and informed. The audits have ranged from mundane billing denials by Medicare Administrative Contractors (MACs) to criminal investigations by the Department of Justice (DOJ). But some RPM companies have become frustrated with audits in which the auditors are not informed about the billing practices and are incorrectly identifying issues.
The American Clinical Laboratory Association (ACLA) and its member company, HealthTrackRx, today announced a victory in its legal challenge to the U.S. Food and Drug Administration’s (FDA) Final Rule that would have regulated virtually all laboratory developed testing services as medical devices. The U.S. District Court for the Eastern District of Texas has vacated the Final Rule in its entirety, holding that FDA’s attempt to regulate professional laboratory testing services as medical devices exceeds the authority granted to FDA in the Food, Drug, and Cosmetic Act (FDCA).
Bipartisan lawmakers have introduced a bill that aims to more closely align Medicare insurers’ prior authorization denials with medical need, as determined by board-certified specialist physicians. The Reducing Medically Unnecessary Delays in Care Act of 2025 was introduced in the House Thursday by Rep. Mark Green, M.D., R-Tennessee, and referred to committee. It is a reintroduction of similar bills brought by the lawmaker in 2023 and 2022.
Clinical associations, philanthropies, and patient and family organizations all responded with alarm to the sweeping restructuring and downsizing at the U.S. Department of Health and Human Services announced on March 27. In the area of research and evaluation, HHS announced it would merge the Assistant Secretary for Planning and Evaluation (ASPE) with the Agency for Healthcare Research and Quality (AHRQ) to create the Office of Strategy.
Twenty-three state attorneys general have filed a lawsuit to block the federal government's rescindment of billions in public health funds to states, cities and organizations. The complaint, filed April 1 in the U.S. District Court for the District of Rhode Island, concerns roughly $11 billion awarded by the Department of Health and Human Services (HHS) near the end of the COVID-19 emergency related to efforts on pandemic preparedness, mental health, overdose prevention, community health programs and public health infrastructure.