Stark Law vs Anti-Kickback Statute
Stark is a civil, strict-liability self-referral law limited to physicians and designated health services. The Anti-Kickback Statute is a criminal, intent-based law covering remuneration to induce referrals for any federally-payable item or service.
Last reviewed May 24, 2026
Side by side
Stark Law
Physician Self-Referral Law — prohibits a physician from referring Medicare/Medicaid patients for designated health services (DHS) to an entity with which the physician (or immediate family) has a financial relationship, unless an exception applies.
42 USC 1395nn- Civil statute, strict liability — no intent required.
- Applies only to physicians and DHS (a defined list).
- Exceptions are detailed at 42 CFR 411.355 et seq.
Anti-Kickback Statute (AKS)
Criminal law prohibiting knowing and willful payment of remuneration to induce or reward referrals for items or services payable by a federal healthcare program.
42 USC 1320a-7b(b)- Criminal statute — requires intent (knowing and willful).
- Applies to any provider, supplier, or person (not just physicians).
- Statutory exceptions and OIG safe harbors at 42 CFR 1001.952.
When to use Stark Law
- Evaluating a physician's referral of Medicare patients for lab, imaging, DME, or other DHS to an entity in which they have a financial interest.
When to use Anti-Kickback Statute (AKS)
- Evaluating any arrangement involving remuneration (cash, gift, free service, below-FMV rent) that could be tied to referrals for federal-program patients.
Common mistakes
- Assuming an AKS safe harbor automatically satisfies a Stark exception (they overlap but are not the same).
- Treating Stark as intent-based — it is strict liability.
- Treating the AKS as physician-only — it applies to any party that pays or receives remuneration tied to referrals.
Sources
- CMS — Physician Self-Referralhttps://www.cms.gov/medicare/regulations-guidance/physician-self-referral
- OIG — Anti-Kickback Statutehttps://oig.hhs.gov/compliance/physician-education/fraud-abuse-laws/
- 42 USC 1395nn (Stark)https://www.govinfo.gov/content/pkg/USCODE-2022-title42/html/USCODE-2022-title42-chap7-subchapXVIII-partE-sec1395nn.htm
- 42 USC 1320a-7b (AKS)https://www.govinfo.gov/content/pkg/USCODE-2022-title42/html/USCODE-2022-title42-chap7-subchapXI-partA-sec1320a-7b.htm
Related
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Open sra studio →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.
This comparison 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 CMS, HHS, OCR, eCFR, NIST, and the relevant payer or state regulator. Last reviewed May 24, 2026.