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Once-in-a-Generation Opportunity to Influence Stark Law Implementation Rules

We are on the clock. As an industry, we have 75 days to comment on the rules published in the Federal Register on October 17 about how the Stark Law is implemented.

This is a unique opportunity. There has not been a stand-alone proposal to change the Stark Law’s implementing regulations for more than a decade. CMS appears receptive to concerns about the burden and practicalities of the technical implementation of the Stark Law requirements. Importantly, CMS has expressed an interest in making fundamental changes regarding the agency’s interpretations of the Stark Law’s meaning and requirements, including those governing the amount and structure of physician compensation arrangements, documentation requirements, the terms of the most commonly used exceptions and new exceptions to promote value-based care.

If some aspect of the Stark Law affects your operations, then you should not miss this opportunity to have your voice heard. The time is now—you may never have a better invitation to provide your input or a more receptive audience. This rule has the potential to significantly change the Stark Law implications of physician relationships with hospitals, group practices or any other entity offering diagnostic imaging, clinical laboratory, outpatient prescription drugs, radiation therapy, DMEPOS, physical or other therapy or home health.

The deadline for the submission of comments to CMS on the proposed Stark Law rule is December 31, 2019. 

© Polsinelli PC, Polsinelli LLP in California


About this Author


Thoroughness and thoughtfulness are the keys to Jeff Fitzgerald’s success in defending health care clients in health care fraud investigations. He believes effective strategies for successfully defending investigations include the rigorous exploration of the facts and a detailed analysis of the applicable regulations. Jeff represents health care providers in disputes with federal and state licensure bodies, professional licensure boards, and other regulators and law enforcement agencies. He also assists health care companies that have proactively discovered potential...

Bruce Johnson, Health Care Organization Attorney, Polsinelli Law FIrm

Bruce Johnson assists clients with a strategic, forward-thinking and pragmatic approach. He brings more than 25 years of legal and management consulting experience to his health care organization clients. Bruce assists hospitals, medical groups, academic practice plans and other health care enterprises in crafting effective relationships to promote business objectives while taking into account strategic, compensation, business operations, compliance, and other issues in today’s changing payment and delivery environments.

Neal Shah, Polsinelli Law Firm, Healthcare Law Attorney

Neal Shah applies his experience in government, private practice, and health care delivery to help identify practical legal solutions to complex regulatory and transactional problems, including:

  • Helping clients comply with the Stark Law, Anti-Kickback Statute, and similar federal and state fraud and abuse laws
  • Establishing and operating Accountable Care Organizations and other coordinated care arrangements
  • Completing self-disclosures of over payments of fraud and abuse liability, including through the CMS Voluntary Self-Referral Disclosure Protocol (SRDP) and...