Mid-Atlantic Health Law TOPICS

340B Program: Did you know that hospitals and other covered entities may have more access to discounted drugs under the 340B program? A recent federal district court decision held that the interpretation of the word patient in the 340B program by the Health Resources and Services Administration (HRSA), which required that a covered entity must initiate the service resulting in the discounted prescription, was narrower than Congress intended. Instead, any patient with an “ongoing relationship” with a covered entity would suffice, meaning more outpatient drug purchases may be eligible for discounts. This decision also complicates the ongoing dispute over the future of the 340B program, driven by pharmaceutical companies who seek to limit available discounts and covered entities who have come to depend on the savings the program provides, since it is now unclear the extent to which HRSA can enforce or prevent restrictions favored by either industry without action from Congress.

Health Data: Did you know that the Office of the National Coordinator for Health Information Technology published a final rule in January 2024, regarding health data, technology, and interoperability. The final rule establishes new transparency and risk management requirements for the use of artificial intelligence (AI) and algorithms used in certified information technology. These new requirements will be important to developers of health IT modules, and go into effect starting January 1, 2025.

Tracking Technologies: Did you know that a number of hospital associations and health systems, including the American Hospital Association, have sued the Department of Health and Human Services Office of Civil Rights (OCR) in regard to its December 2022 tracking technologies bulletin? The OCR bulletin concluded that tracking technologies embedded in most websites are potentially being used in violation of the Health Insurance Portability and Accountability Act (HIPAA). The parties initiating the lawsuit argue that the OCR’s bulletin amounts to a new regulation, and should have followed the required notice and comment period. Those parties further argue that removing this tracking data will remove web tools that are essential, including video technologies, translation and accessibility services, and digital maps about where services can be accessed by patients. The case is still pending in a Texas district court. 

Darci M. Smith
410-576-4153 • dsmith@gfrlaw.com