Stark Law Self-Referral Checklist

A quick self-assessment for physician-owned clinics to identify potential Stark Law exposure. Covers ownership interests, compensation arrangements, ancillary services, and key statutory exceptions to discuss with legal counsel.

Short answer

A self-assessment tool for physician-owned and physician-led clinics to identify referral arrangements that may raise Stark Law issues — and a reference guide to statutory exceptions for discussion with legal counsel.

What is inside

Ownership and investment interest assessment: do any referring physicians have a financial stake in entities they refer to?
Compensation arrangement review: identify direct and indirect compensation that follows referral patterns
Ancillary services inventory: lab, imaging, PT, DME, and home health arrangements
Co-location and specialty arrangement checklist
Statutory exception reference guide: in-office ancillary services, employment, group practice, and more
Clear disclaimer: this checklist identifies areas to review with legal counsel — it does not provide legal advice

We publish the same practical templates and decision tools that clinics use to structure recurring HIPAA work. No enterprise gate. No resource-library gimmicks. Just practical material delivered quickly.

Editorial details

Written by: Angel Campa

Reviewed by: PHIGuard Compliance Research

Updated: April 27, 2026

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Sources

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Stark Law Self-Referral Compliance Checklist for Clinic Owners — assess your referral arrangements today

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Questions

What is the Stark Law?

The Stark Law (42 U.S.C. §1395nn) prohibits physicians from referring Medicare and Medicaid patients to entities providing designated health services (DHS) if the physician or an immediate family member has a financial relationship with that entity — unless a specific statutory exception applies. Financial relationships include ownership, investment interests, and compensation arrangements.

Which services are designated health services under Stark?

DHS under Stark includes clinical laboratory services, physical and occupational therapy, radiology and imaging, radiation therapy, durable medical equipment, home health services, outpatient prescription drugs, inpatient and outpatient hospital services, and others. The full list appears at 42 U.S.C. §1395nn(h)(6) and 42 CFR §411.351.

Does the Stark Law apply to private-pay patients?

The Stark Law applies to Medicare and Medicaid referrals. Similar state self-referral statutes may apply to commercially insured and private-pay patients. Clinics should review both federal Stark requirements and applicable state law.

What happens if a Stark violation is identified?

Violations can result in denial of Medicare and Medicaid claims, repayment obligations, civil monetary penalties, and exclusion from federal health care programs. The Voluntary Self-Referral Disclosure Protocol (SRDP) allows covered entities to self-disclose potential violations to CMS to reduce exposure. This checklist is designed to help you identify issues — not to resolve them. Consult legal counsel before taking any corrective action.