Stark 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.
Primary source
42 USC 1395nn — Office of the Law Revision Counsel →https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section1395nn&num=0&edition=prelim
Verified May 23, 2026 · This is the authoritative regulator URL. The summary below is a research aid; the linked source controls.
Additional sources
42 USC 1395nn — the Physician Self-Referral Law, commonly Stark — prohibits a physician from referring Medicare patients for designated health services (DHS) to an entity with which the physician (or an immediate family member) has a financial relationship, unless an exception applies. The entity may not bill Medicare for DHS furnished pursuant to a prohibited referral.
Stark is strict liability — intent is not required. The prohibition is structural: the financial relationship plus the referral plus the DHS plus the absence of an exception equals a violation.
DHS categories (defined at 42 CFR 411.351): clinical lab, PT/OT/speech-language pathology, radiology and imaging, radiation therapy, durable medical equipment, parenteral and enteral nutrients, prosthetics and orthotics, home health, outpatient prescription drugs, inpatient and outpatient hospital services.
Exceptions at 42 CFR 411.355-357: roughly 30 categories. Strict compliance with every condition is required. Penalties: denial of payment for DHS, refund obligations, CMPs up to $15,000 per service, and exclusion. The Stark Self-Referral Disclosure Protocol allows reduced settlements for self-disclosed violations.
Stark and AKS often overlap; an arrangement must satisfy both regimes.
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Related across the archive
- RegulationStark In-Office Ancillary Services Exception (42 CFR 411.355(b))Ownership/investment and compensation exception permitting many group-practice ancillary services (lab, imaging, PT) when furnished in the same building or centralized building under defined conditions.
- RegulationStark Personal Services Arrangements Exception (42 CFR 411.357(d))Compensation arrangement exception for personal services with conditions parallel to but separate from the AKS personal services safe harbor.
- RegulationStark Rental of Office Space Exception (42 CFR 411.357(a))Stark exception for rental payments for office space with conditions on lease form, term, fair market value, and exclusive use of rented space.
- GlossaryStark LawFederal 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.
- ComplianceCommunicable Disease Reporting: CDC NNDSS + State Health Department RequirementsFederal 42 USC § 247b + CDC NNDSS + state reportable-disease lists: who reports, what conditions, timelines (immediate to weekly), and 45 CFR § 164.512(b) HIPAA permissibility.
- SRAHIPAA Settlements and Civil Money Penalties: A Small-Practice Reading ListHow HHS Office for Civil Rights publishes its enforcement record, the tiered civil money penalty structure at 45 CFR 160.404, and what recent small-practice settlements actually say.
- 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.
- GlossaryDesignated Health Service (DHS)Categories of services subject to the physician self-referral prohibition under the Stark Law.
Last reviewed May 23, 2026 · Citation verified May 23, 2026
Research aid, not legal advice. This summary is an administrative research aid prepared by D3rx. It does not certify compliance, provide legal advice, replace counsel, or guarantee an audit outcome. For authoritative regulatory text follow the primary source link at the top of this page. The practice remains responsible for reviewing, adopting, and maintaining its compliance program.