Stark law compliance is becoming increasingly critical for physicians and healthcare organizations. In 2024 alone, CMS reported a record 314 self-disclosure settlements under the law, totaling more than $24.7 million.
Here is a year-by-year overview of significant Stark law changes since its inception in 1989, according to a blog post from healthcare management company 99MGMT.
1989: Congress enacts Stark law, initially targeting physician referrals for clinical laboratory services. The law officially takes effect on Jan. 1, 1992.
1993-1994: The scope expands to cover additional Designated Health Services, including radiology, physical therapy and other services. Some provisions are extended to Medicaid.
1997: The HHS secretary is granted authority to issue written advisory opinions on whether specific referral arrangements comply with the law.
2003: An exception is added for non-monetary support for electronic prescribing. A temporary moratorium is placed on physician-owned specialty hospitals.
2010: CMS establishes the Medicare Self-Referral Disclosure Protocol, providing a voluntary pathway for providers to report actual or potential violations.
2015: CMS introduces notable updates, including new exceptions for timeshare arrangements and non-physician practitioner recruitment. Requirements around documentation and signatures are also clarified.
2016: Additional clarifications are made to the writing requirements and applicability of exceptions involving compensation arrangements.
2017: CMS releases technical updates, including adjustments to unit-based compensation rules and updates to CPT/HCPCS codes used to define DHS.
2018: The Bipartisan Budget Act formally incorporates certain CMS regulatory clarifications into the statute, reinforcing rules on writing and signature requirements.
2019: CMS proposes substantial reforms to reduce regulatory burden and support the shift toward value-based care.
2020: Sweeping regulatory updates are finalized. These include exceptions for value-based arrangements, clearer definitions of fair market value and commercial reasonableness and a de minimis exception for limited payments to physicians.
2021: Regulatory revisions continue, further addressing value-based compensation models and refining the definitions introduced in 2020.
2022: CMS amends group practice rules to prohibit split pooling of DHS profits. Groups must follow a consistent profit-sharing approach across all physicians or physician subgroups of five or more.
2023: CMS rolls out revised SRDP forms, mandatory as of March 1, 2023, aimed at streamlining the self-disclosure process.
2024: The DHS Code List is updated, including changes related to definitive drug testing and COVID-19 services. CMS also resolves 314 self-disclosure cases, recovering more than $12 million — nearly twice the previous annual record.
2025: The non-monetary compensation limit increases to $519. New CMS guidance offers clarity on value-based care frameworks, indirect compensation and ownership structures, reinforcing compliance expectations in modern practice settings.
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