Stark Law
Federal statute (42 USC 1395nn) prohibiting physicians from referring Medicare/Medicaid patients for designated health services to entities with which the physician has a financial relationship, unless an exception applies.
1 min read · Last reviewed May 23, 2026
At a glance
- Category
- Compliance Program
- Primary sources
- 3
- Workspace handoff
- compliance binder →
Where this comes up
Compliance committees and practice managers operate at this level — written policy, workforce training, sanction policy, monitoring and auditing cadence, response and corrective action. The seven elements of an effective compliance program (OIG) are the scaffolding; this term lives somewhere on that scaffold.
Full definition
What it is in practice
CMS Stark Law is strict liability — intent is not required. Exceptions for in-office ancillary services, employment, personal services, space and equipment leases, and others are detailed at 42 CFR Part 411 Subpart J.
How it shows up in your practice
Self-disclose Stark violations via the CMS SRDP when discovered. The fines for non-disclosure dwarf the cost of disclosure.
Sources
- CMS — Stark Lawhttps://www.cms.gov/medicare/regulations-guidance/physician-self-referral
- 42 CFR Part 411 Subpart J — Starkhttps://www.ecfr.gov/current/title-42/chapter-IV/subchapter-B/part-411/subpart-J
- CMS — Stark Self-Referral Disclosure Protocolhttps://www.cms.gov/medicare/regulations-guidance/physician-self-referral/self-referral-disclosure-protocol
Document Stark analyses in the Compliance Binder
Open compliance binder →Related terms
- Compliance ProgramAnti-Kickback Statute (AKS)Federal criminal statute (42 USC 1320a-7b(b)) that prohibits offering, paying, soliciting, or receiving remuneration to induce or reward referrals for items or services payable by federal health programs.
- DocumentationDesignated Health Service (DHS)Categories of services subject to the physician self-referral prohibition under the Stark Law.
- Compliance ProgramIn-Office Ancillary Services ExceptionStark Law exception (42 CFR 411.355(b)) permitting referrals for designated health services furnished in the referring physician's office.
- Compliance ProgramFMV (Fair Market Value)Compensation, rent, or payment terms that reflect what would be paid in an arm's-length transaction.
- Compliance ProgramOIG Self-DisclosureThe HHS-OIG Self-Disclosure Protocol allowing providers to disclose actual or potential violations of federal fraud and abuse laws.
D3rx is a healthcare-billing and compliance research aid maintained by D3rx Inc. Articles are drafted by an LLM (Anthropic Claude) against primary HHS, OCR, CMS, eCFR, NIST, and state-regulator publications, and reviewed for restraint and source fidelity by the D3rx team.
Reviewer status: a named credentialed reviewer (CHC, CHPC, or healthcare attorney) is being engaged. Until that engagement is finalized, this page does not claim credentialed review.
Related across the archive
- GlossaryFMV (Fair Market Value)Compensation, rent, or payment terms that reflect what would be paid in an arm's-length transaction.
- GlossaryIn-Office Ancillary Services ExceptionStark Law exception (42 CFR 411.355(b)) permitting referrals for designated health services furnished in the referring physician's office.
- GlossaryDesignated Health Service (DHS)Categories of services subject to the physician self-referral prohibition under the Stark Law.
- GlossaryAnti-Kickback Statute (AKS)Federal criminal statute (42 USC 1320a-7b(b)) that prohibits offering, paying, soliciting, or receiving remuneration to induce or reward referrals for items or services payable by federal health programs.
- GlossaryOIG Self-DisclosureThe HHS-OIG Self-Disclosure Protocol allowing providers to disclose actual or potential violations of federal fraud and abuse laws.
- RegulationStark Law Overview (42 USC 1395nn)Strict-liability prohibition on physician referrals to entities for designated health services payable by Medicare when the physician (or immediate family member) has a financial relationship with the entity, unless an exception applies.
- ComplianceStark Law (Physician Self-Referral): Compliance Basics for Designated Health ServicesThe Stark Law is strict-liability, civil-only, and triggers on Medicare claims for designated health services where a financial relationship exists. Here is what Stark actually prohibits, how the exceptions work, and where practices misread the in-office ancillary services exception.
- BillingWhat to Do When a Payer Says You're UnderbillingGot a letter saying you're underbilling? Here's what it actually means, whether you should worry, and what action to take.
This glossary entry is a research aid for billing and compliance staff. It does not provide legal, medical, or financial advice and does not replace counsel. References cited link to primary sources at HHS, OCR, CMS, eCFR, NIST, and the relevant payer or industry body.