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Health Law Highlights

Wade’s Health Law Highlights for November 26, 2024

Dr. Death Redux

Emerging Tech

  • In a randomized clinical trial published in JAMA Network Open, it was found that the use of a large language model (LLM) did not significantly enhance diagnostic reasoning performance among physicians compared to conventional resources. The study involved 50 physicians and showed that while the LLM alone outperformed both groups of physicians, its integration with physicians did not improve diagnostic reasoning. The trial highlighted the need for further development in human-computer interactions to effectively integrate LLMs into clinical practice. Despite the LLM’s potential, the study suggests that simply providing access to LLMs is insufficient to improve diagnostic reasoning in practice.

Fraud & Abuse

Gender-Affirming Care

Health Policy

  • Robert F. Kennedy Jr. has expressed strong opposition to the FDA’s current practices, which he believes suppress public health advancements by limiting access to non-patentable treatments and products. He criticizes the pharmaceutical industry’s reliance on patents, suggesting that many FDA actions are designed to protect this business model. Kennedy advocates for allowing the manufacture and distribution of medical products without FDA approval, permitting broader marketing claims, and opposing regulations on raw milk and certain food additives. His stance suggests a push for more lenient FDA policies regarding unapproved medical uses and claims for “clean foods.” President-elect Trump has indicated he will nominate Kennedy as secretary of health and human services, potentially giving him oversight of the FDA.
  • The Food and Drug Administration (FDA) has made it a federal requirement to inform patients about their breast density when they receive mammograms, following a policy initially enacted in Texas. Higher breast density, characterized by more glandular tissue, can obscure cancer detection on mammograms since both appear white. Patients with dense breasts are advised to undergo more comprehensive exams, such as ultrasounds or MRIs, for better cancer detection. This federal mandate follows the 2012 Texas rule, known as Henda’s Law, which was adopted by 18 other states before becoming a nationwide requirement. Breast cancer remains the most common cancer among women in Texas, with over 21,000 diagnoses expected this year and nearly 3,500 estimated deaths.

Patient Confidentiality

  • The U.S. Department of Health and Human Services, Office for Civil Rights (OCR) has announced a new enforcement initiative called the Risk Analysis Initiative, aimed at ensuring compliance with the HIPAA Security Rule Risk Analysis provision. This initiative is part of OCR’s broader efforts, including its seventh enforcement action related to ransomware, to address deficiencies in how organizations assess risks to electronic protected health information (ePHI). With a reported 264% increase in large breaches involving ransomware since 2018, the initiative emphasizes the need for healthcare entities to evaluate their cybersecurity measures and resource allocation. OCR’s focus is on enhancing the identification and remediation of threats to ePHI, a critical aspect of HIPAA compliance. This initiative follows OCR’s previous enforcement strategy, the Right of Access Initiative, suggesting a continued rigorous approach to ensuring compliance.
  • Elon Musk has been criticized for encouraging users of X, the platform he owns, to upload medical images to its AI tool, Grok, raising concerns about privacy and accuracy issues. Musk claims Grok is in early stages but already quite accurate, though results have been mixed, with some users reporting accurate diagnoses and others experiencing errors. Critics highlight the absence of HIPAA protections on X and ethical concerns about sharing sensitive health data on social media. The New York Times and experts like Bradley Malin emphasize the risks involved, including potential misuse of data and public trust issues. The debate underscores the need for regulation in AI-driven healthcare to prevent misuse and ensure safety.

Risk Management

  • The Office of Inspector General (OIG) has released updated Industry-Specific Compliance Program Guidance (ICPG) for nursing facilities. The 2024 ICPG shifts the focus from fraud prevention to quality of care and resident safety, reflecting the interconnectedness of care quality and compliance. Nursing facilities are encouraged to review their practices, identify gaps, and implement changes to align with the new framework.
  • Overpayments pose significant risks to healthcare providers, leading to financial losses and compliance issues. Statistical Sampling and Overpayment Estimation (SSOE) is a method that uses a small, representative sample of claims to estimate overpayments across a larger pool, offering a cost-effective alternative to reviewing every claim. The SSOE process involves sampling claims, identifying overpayments, and extrapolating results to provide a reliable picture of financial impact. Key data fields for accurate overpayment estimation include claim details, provider and patient information, service codes, and overpayment indicators. SSOE not only helps in compliance and reducing financial risks but also provides insights into improving billing processes and addressing financial leakage.

Taxation

  • The Fifth Circuit denied tax-exempt status to the Memorial Hermann Accountable Care Organization (MHACO), a healthcare nonprofit, under Section 501(c)(4) of the Internal Revenue Code, citing substantial nonexempt purposes. This decision extends the “substantial nonexempt purpose” test, traditionally applied to 501(c)(3) entities, to 501(c)(4) organizations, potentially affecting other nonprofits with similar structures. The court found that MHACO’s activities primarily benefited private healthcare providers and commercial insurers, rather than promoting social welfare, as required for tax exemption. The ruling could impact nonprofits with private membership or financial benefit structures, possibly affecting their operations and governance. Additionally, the decision may influence politically active nonprofits by curbing activities such as political spending.

Telehealth