On October 9. 2019, the Department of Health and Human Services (HHS) announced proposed changes that would update the Physician Self-Referral Law (Stark Law) issued by the Centers for Medicare & Medicaid Services (CMS), and the Federal Anti-Kickback Statute and Civil Monetary Penalties Law issued by the Office of Inspector General (OIG).
According to the announcement from HHS, the proposed rules would ease the compliance burden for healthcare providers while maintaining strong safeguards to protect patients from fraud and abuse. These rules are part of HHS's efforts to promote value-based care by examining efforts that impede efforts among providers to better coordinate care for patients.
Stark Law Proposed Changes
The Stark Law's new value-based exceptions under the proposed rule acknowledge that incentives are different in a healthcare system that pays for value, rather than the volume, of services provided. Proposals to be aware of include, but are not limited to:
- An exception that would protect compensation not exceeding an aggregate of $3,500 per calendar year - as long as specific criteria are met.
- An exception that would protect arrangements involving the donation of certain cybersecurity technology and related services.
Anti-Kickback Statute Proposed Changes
The proposed changes to the regulations related to the Federal Anti-Kickback Statute and the Civil Monetary Penalties Law would, if finalized, address the longstanding concern these laws unnecessarily limit the ways in which healthcare providers can coordinate care for the patient. Proposals to be aware of include, but are not limited to:
- New Anti-Kickback Statute Safe Harbors, including Value-Based Arrangements and Patient Engagement.
- Updates to existing Anti-Kickback Statute Safe Harbors such as Personal Services and Management Contracts Safe Harbor as well as the Electronic Health Records Items and Services Safe Harbor.
"These proposed rules would be a historic reform of how healthcare is regulated in America," said HHS Deputy Secretary Eric Hargan. "They are part of a much broader effort to update, reform, and cut back our regulations to allow innovation toward a more affordable, higher quality, value-based healthcare system, while maintaining the important protections patients need. Here at HHS, CMS and the OIG recognized the need for reform and have acted to produce serious and thoughtful sets of proposals."
HHS is accepting comments on the proposed rules for 75 days from the date of publication in the Federal Register. Healthcare Compliance Pros will be reviewing these proposed changes closely. The proposed rules can be accessed by clicking the following links: