The Centers for Medicare and Medicaid Services (CMS) issued a proposed rule to modernize and clarify the regulations that interpret the Medicare physician self-referral law (often called the “Stark Law”) last October 9, 2019. This piece of legislation has not been updated since it was enacted in 1989.


In the proposal, the “Patients over Paperwork” initiative of CMS takes the center stage as it seeks to reduce the unnecessary regulatory burden on physicians and other healthcare providers while reinforcing the Stark Law’s goal of protecting patients from unnecessary services. Through this initiative, the proposed rule opens additional avenues for physicians and other health care providers to coordinate the care of the patients they serve effectively – allowing providers across different health care settings to work together to ensure patients receive the highest quality of care.


Highlights of the Proposed Changes under Stark Law

Here are some of the highlights on the new proposed changes under the Stark Law:

  • Exceptions for value-based arrangements

    The proposed rule would unleash innovation by permitting physicians and other healthcare providers to design and enter into value-based arrangements without fear that legitimate activities to coordinate and improve the quality of care for patients and lower costs would violate the Stark Law. The exceptions would apply regardless of whether the arrangement relates to care furnished to people with Medicare or other patients.

    The new value-based exceptions include a carefully woven fabric of safeguards to ensure that the Stark Law continues to provide meaningful protection against overutilization and other harms. These proposals recognize that incentives are different in a healthcare system that pays for the value rather than the volume of services provided.

  •  New guidance and clarifications

    The proposed rule would provide additional guidance on several key requirements that must often be met for physicians and healthcare providers to comply with the Stark Law. For example, compensation provided to a physician by another healthcare provider generally must be at fair market value.

    The proposed rule would guide how to determine if compensation meets this requirement. The proposed rule also provides clarity and guidance on a wide range of other technical compliance requirements intended to reduce the administrative burden that drives up costs.


  • Exceptions for a value-based arrangement

    The proposed exceptions would provide new flexibility for certain arrangements, such as donations of certain cybersecurity technology that safeguard the integrity of the healthcare ecosystem, regardless of whether the parties operate in a fee-for-service or value-based payment system. 


CMS press release - CMS Fact Sheet webpage. Follow our monthly publications to find out more, or contact us today!



In the CY 2019, PFS proposed and final rules CMS established two modifiers—one to identify services furnished in whole or in part by a physical therapist assistant (PTA) and the other to identify services furnished in whole or in part by an occupational therapy assistant (OTA).

The new modifiers are required to be used for services furnished on or after January 1, 2020, if applicable.

For more information, please read our September article.

Few months left before the changes. Get ready and check whether your EHR is prepared for the new requirements!