Blog Post

Proposed Rule Changes for Stark Law and Anti-Kickback Statute

Richard P. Kusserow | October 2019

The stated purpose of this proposed rule change is to protect value-based payments, coordinated care, and patient engagement. This will make it easier to provide value-based care in compliance with AKS and Stark Law.

The Department of Health and Human Services (HHS) has proposed changes to modernize and clarify the regulations that interpret the Physician Self-Referral Law (the “Stark Law”) and the federal Anti-Kickback Statute (AKS), in order to provide greater certainty for healthcare providers participating in value-based arrangements and providing coordinated, efficient, and better quality care for patients. The HHS Office of Inspector General (OIG) says that its proposed rules for value-based care are probably more restrictive because the AKS is a criminal, intent-based law. The OIG also proposes to update the definition of remuneration under its Civil Monetary Penalties (CMP) authority. The changes to the remuneration definition are intended to make it easier for home dialysis patients to receive telehealth services and local transportation services. The new value-based exceptions and safe-harbors recognize that the incentives are different in a healthcare system that pays for value, rather than the volume of services provided. The changes would ease the compliance burden for healthcare providers across the industry by: (a) creating new safe harbors to the AKS; (b) adding new exceptions to the Stark Law; (c) revising existing AKS safe harbors; and (d) revising Civil Monetary Penalties (CMP) rules regarding beneficiary inducements. The proposed rules, if finalized, would create new safe harbors and exceptions for certain value-based care arrangements and make it easier for physicians and other healthcare providers to ensure they are complying with these laws when entering such arrangements. Arrangements focused on coordinated care, value-based care, data sharing, and patient engagement activities, depending on the facts, could potentially be protected if all applicable conditions are met.  The following are examples of potentially protected arrangements:

  • A specialty physician practice could share data analytics services with a primary care physician practice regarding a common patient.
  • Hospitals and physicians could work together in new ways to follow-up with patients discharged from hospitals, such as coordinating care, using data analytics systems to ensure patients are achieving positive health outcomes, and remote monitoring of patients.
  • A physician practice could provide smart pillboxes to patients without charge to help them remember to take their medications on time and automatically alert the physician practice and caregiver when a patient misses a dose so they could follow up promptly with the patient.
  • A local hospital could improve its cybersecurity and the cybersecurity of those it works with frequently by donating cybersecurity software to outside providers. The software would help ensure that hackers cannot attack the donator or recipient physician’s computers.
  • To improve health outcomes for patients with end-stage kidney disease, a nephrologist, dialysis facility, or other provider could furnish the patients with technology that can monitor the patient’s health and two-way, real-time interactive communication between the patient, facility, and physician.  In addition, the facility could equip the physicians with data analytics software to help them monitor patients’ health outcomes.

Both the Centers for Medicare and Medicaid Services and the HHS OIG are soliciting public comments on the details of their proposals and related matters until Dec. 31, 2019.

About the Author

Richard P. Kusserow established Strategic Management Services, LLC, after retiring from being the DHHS Inspector General, and has assisted over 3,000 health care organizations and entities in developing, implementing and assessing compliance programs.

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