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Health Law Highlights

Wade’s Health Law Highlights for March 11, 2025

False Claims Act

FDA

  • A U.S. District Court has allowed Novo Nordisk to intervene in a case between the FDA and compounding pharmacies. Compounders sued the FDA for removing weight loss drugs from its shortage list, which had previously allowed them to produce copycat versions of Novo’s semaglutide products. The compounders claim the agency’s decisions were arbitrary and that shortages persist. Novo Nordisk cited safety concerns and investment protection in its motion to intervene, which was unopposed by both the FDA and the compounders. Eli Lilly has also filed a motion to intervene in the ongoing legal proceedings.

Medicare

  • CMS has revised its Medicare overpayment rule, replacing the “reasonable diligence” standard with a “knowingly” standard that only requires action when providers are aware of overpayments. The update extends the investigation timeline, giving healthcare organizations 180 days to conduct investigations before the 60-day repayment clock begins. Organizations must keep documentation of compliance efforts and implement processes for identifying, reporting, and returning overpayments. Healthcare providers who fail to address identified overpayments risk penalties under the False Claims Act, which can include treble damages and civil penalties. The new framework tries to streamline compliance while maintaining accountability through structured investigation protocols and documentation requirements.
  • Medicare reimbursement rates for radiologists have declined by 24.9% from 2005 to 2021 after inflation adjustments, while the average starting salary for radiologists reached $472,000 in 2023, representing a 17.7% increase since 2020. The workforce faces significant pressures with 56.4% of diagnostic radiologists being 55 or older, while new trainees are only increasing by 2.5% annually. The implementation of the No Surprises Act has complicated reimbursements for out-of-network services, and healthcare cybersecurity costs have reached $10.93 million per data breach in 2023. These challenges are pushing independent radiology groups to seek financial subsidies from hospital partners to maintain operations.

Nonprofits

  • Nonprofit healthcare organizations are increasingly pursuing mergers to address economic challenges and improve care delivery. These mergers can take the form of either member substitutions, where one organization becomes a controlling member while both entities remain separate, or true mergers that combine organizations into a single legal entity. The consolidations try to achieve cost efficiencies, increase bargaining power with insurance companies, and improve access to capital for technology investments and facility improvements. Mergers also enable organizations to expand their geographic reach, enhance quality of care, and invest in innovations like telemedicine and data analytics. The process requires careful consideration of mission alignment, organizational culture, and governance structures to ensure the merged entity can effectively serve its community while maintaining financial stability.

Physician-Patient

  • Healthcare providers who wish to terminate a patient relationship must follow specific protocols to avoid patient abandonment claims. The process requires providers to notify patients in writing of the termination, explain the reasons professionally, and give patients reasonable time (typically 30 days) to find new care. During the transition period, providers must continue necessary care and facilitate the transfer of medical records to the new provider. While providers can terminate patient relationships for valid reasons like non-compliance or non-payment, they must follow applicable laws regarding discrimination and emergency care, with exceptions only for situations posing immediate safety risks.

Ransomware

Security

Stark Law

  • The Centers for Medicare & Medicaid Services settled 314 Stark Law self-disclosures in 2024, collecting $24.7 million in settlements. The number of settlements in 2024 exceeded the combined total of the previous two record years and represented over one-third of all settlements in the program’s 14-year history. The average settlement amount was $78,781.39, consistent with trends from recent years, while 51 submissions were withdrawn during 2024. CMS has increased its processing speed for settlements, with some cases now resolved within the same calendar year as submission, marking a significant improvement from previous processing times. The smallest settlement in 2024 was $4, while the largest settlement on record remains $1,196,188 from 2018.

Transparency

  • On February 25, 2025, President Trump signed an executive order focusing on healthcare price transparency. The order instructs the secretaries of Treasury, Labor, and Health and Human Services to implement new requirements within 90 days, mandating disclosure of actual prices rather than estimates. The directive tries to standardize pricing information across hospitals and health plans while updating enforcement policies for transparent reporting. Under current rules, hospitals must publish machine-readable files of standard charges using Centers for Medicare & Medicaid Services templates and provide price estimator tools for shoppable services.