Stark for the Solo Practice: Mostly No — and the Exceptions That Surprise

Does Stark apply to a solo practice?

Usually, no. The Stark law — the physician self-referral statute — applies only when a physician refers a Medicare or Medicaid patient for a designated health service to an entity with which the physician, or an immediate family member, has a financial relationship, and no exception applies. It is strict-liability and administered by CMS 1Ref 1Centers for Medicare & Medicaid Services (2026).Physician Self-Referral.That the Stark law is strict-liability, administered by CMS, applies to physicians referring designated health services, and permits in-office ancillary services under a defined exception..

Three conditions must all be present for Stark to attach: a physician, a designated health service, and a financial relationship with the entity furnishing it. Break any one of the three and Stark is not in play. For most solo practices, one or more of those conditions is simply absent — which is why the honest answer is usually that the law does not reach you, even though it deserves a real check rather than a shrug.

Who counts as a 'physician' — and who doesn't

Stark defines "physician" narrowly, and the definition is where most solo practices fall outside the law entirely. A doctor of medicine or osteopathy, a dentist, a podiatrist, an optometrist, or a chiropractor is a physician for Stark; a psychologist, licensed clinical social worker, professional counselor, or marriage and family therapist is not 1Ref 1Centers for Medicare & Medicaid Services (2026).Physician Self-Referral.That the Stark law is strict-liability, administered by CMS, applies to physicians referring designated health services, and permits in-office ancillary services under a defined exception..

If your practice is talk therapy, you are almost certainly not making Stark referrals: psychotherapy is not on the designated-health-services list, and you are not a Stark physician. Two of the three conditions fail at once. The law becomes relevant when a physician-owned practice refers designated services in-house — the setting the next section covers — or when a physician and a therapist share ownership of an entity that furnishes designated services.

The exception that surprises: in-office ancillary services

The exception that surprises solo physicians is the in-office ancillary services exception. Stark generally bars referring designated health services to an entity you have a financial interest in — which would sweep in your own practice — so the law carves out an exception that lets a physician bill for in-office labs, imaging, or physical therapy furnished within the practice, provided defined supervision, location, and billing conditions are met 1Ref 1Centers for Medicare & Medicaid Services (2026).Physician Self-Referral.That the Stark law is strict-liability, administered by CMS, applies to physicians referring designated health services, and permits in-office ancillary services under a defined exception..

Without that exception, ordering an in-office test would itself be a self-referral. With it, the same test is fine — but only if every element is satisfied. That is the trap: physicians assume in-house services are automatically permitted, when they are permitted only because an exception with conditions is doing the work. If the conditions slip — the wrong supervision level, a service furnished at a location the exception does not cover — the referral reverts to a strict-liability violation.

Incident-to: where adding staff pulls in another rule

Adding staff pulls in a separate rule that solo practices routinely misread: incident-to billing. When a supervising physician bills for services a staff member delivers, incident-to requires a direct employment or contract relationship, direct supervision with defined exceptions, and an already-established course of treatment the physician began 2Ref 2Office of the Federal Register (2026).42 CFR 410.26 — Services and supplies incident to a physician's professional services.That incident-to billing requires an employment or contract relationship, direct supervision with defined exceptions, and an initiating service by the physician..

Incident-to is not a Stark exception, but the two intersect. The financial relationship with the staff member and the referral of the service each have to sit inside their own rules before the claim is clean. A solo practice that hires its first clinician often gets the clinical supervision right and the billing conditions wrong, which produces claims that were never payable as billed. Confirm the incident-to elements before the first such claim goes out, not after a payer flags them.

Stark vs the anti-kickback statute — don't conflate them

Do not conflate Stark with the anti-kickback statute — they are different laws with different tests. Stark is strict-liability and needs no bad intent; the anti-kickback statute turns on whether remuneration was offered or received to induce referrals, and it protects specific arrangements through regulatory safe harbors — space and equipment rental, personal services, employment, and others, each with required elements 3Ref 3Office of the Federal Register (2026).42 CFR 1001.952 — Exceptions (Anti-Kickback Safe Harbors).That the anti-kickback safe harbors are defined by regulation — rental, personal services, employment, and others — each with required elements protecting an arrangement..

This is the Stark-AKS pair that governs referral flow without buying it. The safe harbors you actually touch as a solo are the mundane ones — a sublease from another practice, a 1099 arrangement, a marketing deal — and each has elements you either meet or you don't. The line between practice marketing and paying for referrals is exactly where these arrangements go wrong. When you are unsure whether a specific arrangement even implicates the anti-kickback statute, the OIG publishes advisory opinions on specific arrangements that show how it reasons 4Ref 4HHS Office of Inspector General (2026).Advisory Opinions.That the OIG issues and publishes advisory opinions on whether specific arrangements implicate the anti-kickback statute..

The rules that actually reach a solo office

Stark rarely reaches a solo behavioral-health practice; other federal rules certainly do, and they mostly turn on activity, not practice size. A few rules do scale by headcount — employers with ten or fewer employees are exempt from routine OSHA injury and illness recordkeeping, though severe-incident reporting still applies 5Ref 5Occupational Safety and Health Administration (2026).Recordkeeping.That employers with ten or fewer employees are exempt from routine OSHA injury and illness recordkeeping, while severe-incident reporting still applies — an example of a size-based rule.. Stark is not one of those: it turns on physician status and Medicare or Medicaid referrals, not on how small you are.

OSHA and the solo office is one example of a size-based line. Activity-based rules are the ones that catch a solo off guard: the No Surprises Act, for instance, requires a good-faith estimate for any uninsured or self-pay patient regardless of practice size 6Ref 6Centers for Medicare & Medicaid Services (2026).No Surprise Billing.That the No Surprises Act requires a good-faith estimate for uninsured or self-pay patients regardless of practice size — an activity-based obligation.. The NSA for office practice applies the day you see your first self-pay patient. So the short answer to "does Stark apply to me" is usually no — but "which federal rules apply to me" has a longer answer, and it is worth mapping which are size-based and which are activity-based so your compliance attention lands where it matters.

How to check a specific arrangement

When you cannot tell whether an arrangement or referral is a problem, there are two moves before you sign anything. First, read the OIG's published advisory opinions for the arrangement closest to yours — they bind only the requester, but they reveal how the agency reasons 4Ref 4HHS Office of Inspector General (2026).Advisory Opinions.That the OIG issues and publishes advisory opinions on whether specific arrangements implicate the anti-kickback statute.. Second, keep the minimum compliance response the OIG expects even from a practice of one: its General Compliance Program Guidance scales the seven elements to small practices, including a defined path for spotting and correcting problems 7Ref 7HHS Office of Inspector General (2023).General Compliance Program Guidance.That the OIG's General Compliance Program Guidance scales the seven elements of an effective compliance program, including detecting and correcting problems, to small practices..

Bring in counsel before you commit when:

• You are a physician planning to bill designated health services furnished in your own office.
• An arrangement involves paying or receiving anything of value tied to a referral source.
• You are adding staff and plan to bill their services incident-to.
• Family members, ownership stakes, or another entity are part of the deal.

For a solo therapist doing talk therapy, Stark is almost never the question — but the arrangement-checking discipline is worth keeping for the anti-kickback questions that do arise.