---
title: "What Is the Stark Law? Physician Self-Referral Explained"
description: "The Stark Law bars physician referrals for Medicare designated health services to entities they have financial ties to. What it covers and how it differs."
canonical: "https://cuvo.co/glossary/stark-law"
last-updated: "Oct 26, 2026"
---
**Definition:** The Stark Law, 42 U.S.C. 1395nn, bars a physician from referring patients for designated health services payable by Medicare to an entity with which the physician or an immediate family member has a financial relationship, unless an exception applies, and bars that entity from billing for them.

# What is the Stark Law (physician self-referral law)?

The Stark Law is the federal physician self-referral rule: a narrow, strict liability statute aimed at physician referrals that Medicare or Medicaid pays for. It matters to a telehealth brand mainly when labs, pharmacies or government payers enter the picture. Cuvo Health runs cash-pay programs with no insurance dependencies.

Published Oct 26, 2026. Facts reviewed Oct 26, 2026.

The Stark Law, 42 U.S.C. 1395nn, bars a physician from referring patients for designated health services payable by Medicare to an entity with which the physician or an immediate family member has a financial relationship, whether an ownership interest or a compensation arrangement, unless an exception applies, and bars the entity from billing for services furnished on a prohibited referral. 42 U.S.C. 1396b(s) extends the rule to Medicaid. It is civil and strict liability: no intent is required. It does not reach every payer or every clinician. On Cuvo Health, programs are cash-pay with no insurance dependencies, labs run through Labcorp and Quest, and prescriptions go to licensed partner pharmacies.

**At a glance**
- Citation: 42 U.S.C. 1395nn; regulations at 42 CFR 411.351 and following
- Who it covers: Physicians as defined in 42 U.S.C. 1395x(r), and the entities they refer to
- What business: Designated health services payable by Medicare, and by Medicaid through 42 U.S.C. 1396b(s)
- Intent: None required; HHS-OIG calls it a strict liability statute
- On Cuvo: Cash-pay programs with no insurance dependencies

**Stark Law vs Anti-Kickback Statute (statute text checked October 26, 2026)**

| Question | Stark Law | Anti-Kickback Statute |
| --- | --- | --- |
| **Citation** | 42 U.S.C. 1395nn | 42 U.S.C. 1320a-7b(b) |
| **Who it covers** | Physicians and their immediate family members, and the entities that bill on their referrals | Anyone who offers, pays, solicits or receives remuneration |
| **Business covered** | Designated health services payable by Medicare, and by Medicaid through 1396b(s) | Any item or service payable by a federal health care program |
| **Intent** | None required | Knowing and willful |
| **Penalties** | Denial of payment, refunds, civil monetary penalties up to $15,000 per service and $100,000 per circumvention scheme | Felony fines up to $100,000 and up to 10 years in prison; civil monetary penalties |
| **Way out** | Statutory and regulatory exceptions | Safe harbors at 42 CFR 1001.952 |

## 01. What are designated health services under the Stark Law?

Twelve categories listed at 42 U.S.C. 1395nn(h)(6): clinical laboratory services; physical therapy; occupational therapy; radiology and imaging, including MRI, CT and ultrasound; radiation therapy; durable medical equipment and supplies; parenteral and enteral nutrients; prosthetics and orthotics; home health services; outpatient prescription drugs; inpatient and outpatient hospital services; and outpatient speech-language pathology. CMS defines outpatient prescription drugs at 42 CFR 411.351 as drugs covered by Medicare Part B or Part D.

## 02. Does the Stark Law apply to telehealth?

Stark follows the referral, the financial relationship and the payer, not the channel of care. A physician seeing patients by video who refers a Medicare patient for lab work to a lab the physician invests in faces the same rule as one in an office. A program that bills no designated health service to Medicare or Medicaid does not generate the claims the federal law governs, but state self-referral laws can still apply: Florida's Patient Self-Referral Act, section 456.053(5)(a), bars a provider from referring a patient for designated health services to an entity the provider invests in, and its text is not limited to government payers.

## 03. Who counts as a physician under the Stark Law?

The definition at 42 U.S.C. 1395x(r): MDs and DOs, plus dentists, podiatrists, optometrists and chiropractors within limits. Nurse practitioners and physician assistants are not in that list, but 42 CFR 411.353(a) lets a referral made by a physician's group practice or staff be imputed to the physician who directs or controls it.

## 04. How is the Stark Law different from the Anti-Kickback Statute?

Stark is narrower and stricter: it covers only physicians, only designated health services and only Medicare and Medicaid, but it needs no intent. The Anti-Kickback Statute covers anyone and any federal program item or service, and requires a knowing and willful act. One arrangement can raise both, and a claim tainted by either can also become a False Claims Act problem.

## Frequently asked questions

**Q: What is the Stark Law?**

A: It is the federal physician self-referral law, 42 U.S.C. 1395nn, which bars physicians from referring Medicare and Medicaid patients for designated health services to entities they have a financial relationship with, unless an exception applies. On Cuvo, programs are cash-pay with no insurance dependencies.

**Q: Stark Law vs Anti-Kickback Statute: what is the difference?**

A: Stark is a civil, strict liability rule limited to physician referrals for Medicare and Medicaid designated health services; the Anti-Kickback Statute is a criminal intent law covering anyone and any federal program business. Cuvo Health operates cash-pay programs and charges brands flat, published fees with no revenue share.

**Q: What are designated health services?**

A: They are the twelve categories in 42 U.S.C. 1395nn(h)(6), including clinical laboratory services, imaging, durable medical equipment, home health, outpatient prescription drugs and hospital services. On Cuvo, labs run through Labcorp and Quest and prescriptions go to licensed partner pharmacies, on cash-pay programs.

**Q: Does the Stark Law apply to nurse practitioners?**

A: Nurse practitioners are not physicians under 42 U.S.C. 1395x(r), but a referral a physician directs or controls can be imputed to that physician under 42 CFR 411.353(a). Cuvo Health's network includes physicians, nurse practitioners and physician assistants, each practicing within its state's scope.

**Q: What are the Stark Law exceptions?**

A: They are statutory and regulatory carve-outs, such as the personal service arrangements exception at 42 CFR 411.357(d), that let a financial relationship stand if every condition is met. On Cuvo, the MSO structure and its agreements are built and maintained by Cuvo.

**Related pages**

- [Anti-Kickback Statute](/glossary/anti-kickback-statute): The criminal referral-payment law beside Stark
- [Fair market value in healthcare](/glossary/fair-market-value-healthcare): The pricing test Stark defines
- [Fee-splitting laws](/glossary/fee-splitting): State rules on sharing professional fees
- [Cuvo labs](/labs): Lab ordering and provider review under the brand's name
- [Cuvo compliance](/compliance): The structure Cuvo builds and maintains for every brand

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