As part of their self-described efforts “to modernize and clarify the regulations that interpret the Physician Self-Referral Law (the ‘Stark Law’) and the Federal Anti-Kickback Statute,” the Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS) recently proposed sweeping changes to the interpretation and application of those two healthcare law statutes.
Rule Change Seeks to Reduce Regulatory Requirements
Announced on October 9, 2019, the proposed rule focuses on easing regulatory burdens on physicians and healthcare organizations to allow for greater patient access to “value-based care.” This includes the coordination of care across different healthcare settings as well as “data sharing and patient engagement activities that, depending on the facts, could currently be difficult to fit under existing protections.”
In its announcement, HHS listed examples of activities that “could potentially be protected by the Stark Law, Anti-Kickback Statute, or Civil Monetary Penalties Law proposals if all applicable conditions are met.” These include:
- Allowing a specialty physician practice to share analytics services with a primary physician care practice to coordinate and manage the care of their shared patients.
- Facilitating better care of discharged hospital patients by permitting a hospital to provide the discharged patients’ physicians with care coordinators, data analytics systems, and remote monitoring technology to alert physicians or caregivers when a patient needs healthcare intervention to prevent unnecessary ER visits and readmissions.
- Permitting a physician practice to provide smart pillboxes that could automatically alert the physician practice and caregiver when a patient misses a dose so they could follow up promptly with the patient.
- Allowing a hospital to donate, free of charge, cybersecurity software to each physician that refers patients to its hospital to help ensure that hackers can’t attack the physician’s computers and prevent hackers from spreading an attack to other practices and the hospital.
The proposed rule also includes:
- Guidance to help determine whether compensation paid to a physician is fair market value.
- Six new Anti-Kickback Statute safe harbors (including three for value-based arrangements) and modifications to four existing safe harbors.
- A codification of the statutory exception to the Anti-Kickback Statute’s definition of “remuneration” related to ACO Beneficiary Incentive Programs for Medicare Shared Savings Programs.
The proposed rule will be published in the Federal Register on October 17, 2019, and comments will be due 75 days thereafter.
Questions About the Stark Law and Proposed Changes? Call the Healthcare Attorneys at Kreis Enderle Today
If finalized, we anticipate that physicians and healthcare organizations will have greater flexibility – and less anxiety – about coordinating services and providing better patient care across practices, hospitals, and other facilities. As with all new regulations, however, complexities and questions will no doubt arise. When they do, the healthcare attorneys at Kreis Enderle will be ready to supply the guidance and answers that can help those in the healthcare industry pursue new opportunities while effectively managing risk.
To arrange for a consultation, please contact one of our Healthcare attorneys.