Insights

Washington – August 17, 2023: The 2024 edition of The Best Lawyers in America® has recognized 47 firm lawyers as "Best Lawyers" and 41 lawyers as “Ones to Watch.”

On January 17, 2024, the Centers for Medicare & Medicaid Services (CMS) issued the Interoperability and Prior Authorization Final Rule (Final Rule), which establishes requirements applicable to certain impacted payers which are intended to improve the electronic exchange of health information and prior authorization processes. The application programming interface (API) requirements will take effect January 1, 2027, while the operational provisions will take effect January 1, 2026. CMS has issued a helpful slide deck summarizing the Final Rule.

On December 13, 2023, the U.S. Department of Health and Human Services' (HHS) Office of the National Coordinator for Health Information Technology (ONC) released the Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) Final Rule. The effective date of the HTI-1 Final Rule is updated and is now March 11, 2024.

The Office of the Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) published the General Compliance Program Guidance (GCPG) on November 6, 2023. The GCPG provides updated descriptions of the seven elements of an effective compliance program that health care entities have long relied upon. The new guidance also includes recommendations to conduct annual internal risk assessments, to consider quality of care as a component of the compliance program, and to emphasize the importance of a board’s and executive leadership’s oversight of compliance.

Our health care landscape is rapidly transforming. As the health care space has become more digitized and more reliant on technology than ever before, artificial intelligence (AI), telehealth services, data analysis, and medical devices have become drivers of our health care system. Likewise, value-based care is becoming increasingly popular among delivery systems, leaving accountable care organizations (ACOs) to adhere to changing federal compliance requirements. The burden falls on health care entities to remain up-to-date on how care is evolving as federal and state compliance regulations and privacy concerns continue to develop.

Join us for this year’s Health Care Ounce of Prevention Seminar (HOOPS), a webinar series where our experienced practitioners will provide insight into a number of exciting topics. This year’s seminar will focus on topics such as Remote Health Care and Telemedicine, Mental Health Parity, Health Care Litigation, and Health Care Trends for 2022. 

Please join members of Crowell & Moring’s Health Care Group for a summary and analysis of the Centers for Medicare and Medicaid (CMS) interim final rule modifying the conditions of participation by requiring health care staff at Medicare and Medicaid facilities to be fully vaccinated. 

In this episode, hosts Payal Nanavati and Joe Records talk to Lidia Niecko-Najjum and John Brennan about the legal issues that investors, providers, and innovators should be prepared to navigate when considering offering Ketamine-assisted treatment, including the federal and state laws and regulations related to the practice of medicine, licensure, and many other issues.