Stark Law (42 CFR 411)

Prohibits physician self-referrals for designated health services payable by Medicare or Medicaid, unless a specific exception applies. Applies to physicians and entities that furnish designated health services.

Stark Law applies to physicians, hospitals, clinical laboratories, entities providing designated health services.

AuditDSS has decomposed Stark Law into 1,871 atomic obligations from 94 rules. Each obligation is independently testable and risk-scored.

The key requirements include: physician self-referral prohibition, designated health services list, compensation arrangement exceptions, ownership exceptions, reporting requirements, refund obligations.

Upload your compliance policy to AuditDSS. The platform maps your document against all 1,871 Stark Law obligations using deterministic AI scoring — not checklists or LLM summaries. You get a risk-scored gap analysis showing exactly which obligations are covered, partially covered, or missing.

Stark Law is enforced in United States by Centers for Medicare & Medicaid Services.

Stark Law became effective on January 1, 1992.

Stark Law is primarily relevant to the Medical Devices & Diagnostics industry. AuditDSS covers 64 regulations in this industry sector.