A physician arrangement tracking program records financial arrangements involving entities furnishing Medicare-payable designated health services and referring physicians or their immediate family members for review under the Stark Law and federal Anti-Kickback Statute. Integral Healthcare Solutions (IHS) designs inventories, checklists, renewal calendars and sign-off procedures for hospitals, health systems and physician groups. Counsel decides whether arrangements meet an exception or safe harbor.
Last updated: November 2026
What do the Stark Law and the Anti-Kickback Statute prohibit?
Under 42 CFR 411.353(a), except as the subpart provides, a physician who has a direct or indirect financial relationship with an entity, or whose immediate family member has one, may not refer to that entity for designated health services (DHS) for which Medicare payment otherwise may be made. This page summarizes 411.351, 411.353, 411.354, 411.357 and 1001.952 (eCFR, title 42 last amended October 8, 2026; title 45 last amended November 3, 2026) and 42 U.S.C. 1320a-7b (2024 edition), opened November 5, 2026, as were the OIG guidance, CMS table and DOJ release cited below. State law is not covered.
What happens when a referral is prohibited?
- An entity furnishing DHS under a prohibited referral may not submit or cause submission of a claim or bill for it to Medicare, any individual, any third party payer or other entity (411.353(b)), and no Medicare payment may be made, except as paragraph (e) provides for an entity with no actual knowledge of, and no reckless disregard or deliberate ignorance of, the referring physician's identity whose claim otherwise complies with applicable law (411.353(c)(1), (e)). An entity that collected payment must refund all collected amounts on a timely basis, as defined at 42 CFR 1003.110 (411.353(d)).
- OIG's November 2023 General Compliance Program Guidance (GCPG) calls the Stark Law strict liability: proof of intent to violate the law is not required (PDF page 16). Civil money penalties have separate conditions under 42 CFR 1003.300. After inflation adjustment, 45 CFR 102.3 lists the 2025 maximums for those two Stark penalties as 31,670 dollars per claim and 211,146 dollars per circumvention scheme.
Which relationships count?
A financial relationship is a direct or indirect ownership or investment interest in, or compensation arrangement with, an entity that furnishes DHS (411.354(a)(1)). A compensation arrangement involves direct or indirect remuneration between an entity and a physician or immediate family member, including a hospital's "under arrangements" contract with an entity furnishing DHS. It excludes the portion consisting solely of remuneration described in section 1877(h)(1)(C) and 411.351 remuneration paragraphs (1)–(3); another portion may still count (411.354(c)).
Which dates and documents does the regulation tie to an arrangement?
- Set in advance. Compensation is deemed set in advance if aggregate compensation, a time-based or per-use or per-service amount, or a specific formula is written before the compensated items, services, office space or equipment are furnished; the formula must permit objective verification (411.354(d)(1)(i)). Modifications must meet all conditions in (d)(1)(ii).
- Writing and signature. For a compensation arrangement, a writing or signature requirement under the Stark subpart is satisfied if the arrangement otherwise fully complies with an applicable exception in that subpart and the parties obtain the required writings or signatures within 90 consecutive calendar days immediately after they were required but not obtained (411.354(e)(4)). This rule does not apply to writing modified compensation formulas under (d)(1)(ii)(C).
- Temporary lapse. An entity may bill for DHS furnished while it rectifies a lapse, for no more than 90 consecutive calendar days following the lapse, only if the relationship fully complied with an exception for at least 180 consecutive calendar days immediately before, the lapse was beyond its control and the entity promptly takes steps to rectify it; once every 3 years per referring physician, and not where the earlier exception was 411.357(k) or (m) (411.353(f)).
- Reconciliation. An entity may bill for DHS if, within 90 consecutive calendar days after a compensation arrangement expires or terminates, the entity and the physician (or the physician's immediate family member) who are parties to it reconcile all payment discrepancies so all remuneration for items or services has been paid under the arrangement's terms and conditions. Apart from those discrepancies, the arrangement must fully comply with an applicable exception in the Stark subpart (411.353(h)).
What do the common exceptions require?
Under 42 CFR 411.357, office space leases (a), equipment leases (b), bona fide employment (c) and fair market value compensation (l) have conditions of their own.
| Arrangement | Elements in the text |
|---|---|
| Personal services, (d)(1): contract records | Except for services under arrangements satisfying all conditions of (z), the arrangements must cover all services the physician or immediate family member furnishes to the entity. That coverage requirement is met if all separate arrangements between the entity and the physician and between the entity and any family members incorporate each other by reference or cross-reference a centrally maintained and updated master contract list, available to the Secretary on request and preserving contract history. This describes only (d)(1)(ii); counsel reviews every applicable condition in (d)(1). |
What does the Anti-Kickback Statute add?
Subject to (b)(3), 42 U.S.C. 1320a-7b(b)(1)–(2) prohibits knowingly and willfully soliciting or receiving remuneration in return for the conduct below, or offering or paying remuneration to a person to induce that person to engage in it: referring an individual to a person to furnish or arrange to furnish federally payable items or services; or purchasing, leasing, ordering, arranging for or recommending purchases, leases or orders of federally payable goods, facilities, services or items. This covers direct or indirect, overt or covert remuneration, in cash or in kind, and payment in whole or in part by a Federal health care program. Upon conviction, the felony carries up to 100,000 dollars, 10 years' imprisonment, or both. A payment practice that meets all the applicable standards of a paragraph in 42 CFR 1001.952 is not treated as a criminal offense under section 1128B and does not serve as the basis for an exclusion.
Who needs a tracking program, and what do OIG, CMS and DOJ publish about tracking?
In IHS's November 5, 2026 reading, tracking serves entities furnishing Medicare-payable DHS with direct or indirect financial relationships involving referring physicians or their immediate family members (411.353(a)). The GCPG is voluntary, nonbinding guidance. Its section V.D says entities should consider what type of centralized arrangements tracking system to establish, depending on organization size, so that supporting documentation is maintained, regular legal reviews are conducted, and fair market value assessments are performed and updated routinely as appropriate (PDF page 80).
CMS's settlement table (last modified March 16, 2026) lists settled disclosures under its self-referral disclosure protocol: 27 in 2021, 103 in 2022, 176 in 2023, 314 in 2024 and 244 in 2025, and 1,234 from 2011 through 2025, totaling 105,090,031 dollars.
On December 18, 2023, the Department of Justice announced that Community Health Network, Inc. agreed to pay the United States 345 million dollars to resolve allegations that it violated the False Claims Act by knowingly submitting Medicare claims for services referred in violation of the Stark Law.
How does IHS build a tracking program?
IHS assesses gaps against counsel-identified requirements, maps documents and evidence, drafts procedures, and conducts a mock review and readiness check. Client clinicians approve any clinical content. The calendar assigns owners to expiry, renewal, writing, signature and applicable 90-day deadlines.
What IHS drafts
IHS drafts inventories, checklists, master contract lists, calendars, review procedures and sign-off logs.
What you supply
Every contract and amendment, payment records, your counsel's exception choices, valuation reports, and who signs.
The real limit
Counsel gives every legal opinion, approves contract forms and advises on any disclosure. IHS does not contact CMS, OIG or any agency. Thomas G. Goddard, JD, PhD, IHS founder and former URAC Chief Operating Officer and General Counsel, leads the work. It sits in Compliance Services, one of three IHS practice lines; see also compliance program development.
What should an entity have ready before the first session?
Checklist citations use current title 42 eCFR, last amended October 8, 2026; page opened November 5, 2026.
- Physician and immediate-family contracts and amendments, including "under arrangements" contracts (42 CFR 411.354(c)).
- Ownership or investment interests, including interests through another entity (42 CFR 411.354(b)).
- Any master contract list (42 CFR 411.357(d)(1)(ii)).
- Writing, signature and service-start dates (42 CFR 411.354(d)(1)(i), (e)(4)).
- Verifiable compensation formulas and modifications with effective dates (42 CFR 411.354(d)(1)).
- Valuation documents and commercial-reasonableness rationale (42 CFR 411.351).
- Payment, reconciliation and lapse records (42 CFR 411.353(f), (h)).
The free introductory call is where IHS walks through the list with you.
How does a tracking program differ from a legal review or a valuation?
| Option | What it produces | Who owns the result |
|---|---|---|
| Tracking program | Register, checklists, calendar, sign-off log | Your compliance team, with IHS drafting |
| Legal review | Whether an arrangement meets an exception or safe harbor | Your counsel |
| Valuation | An opinion on value | The valuation firm |
What does it cost?
None of the government sources cited on this page lists a fee for building a tracking program. IHS scopes each engagement after a free introductory call.
What this is not
- IHS is a consulting firm, not a law firm; this page is not legal advice or an opinion on any arrangement.
- It is not a filing. If an entity self-discloses, its counsel and officers decide and submit; IHS does not contact CMS or OIG.
Frequently asked questions
What is a physician arrangement tracking program?
It records financial arrangements involving an entity and referring physicians or their immediate family members. IHS drafts the records; counsel reviews compliance.
Is a tracking program required by law?
The cited sections do not require a named tracking system. OIG's voluntary, nonbinding November 2023 General Compliance Program Guidance, V.D, says entities should consider what type of centralized arrangements tracking system to establish, depending on organization size.
What does set in advance mean, and can compensation change during an arrangement?
Under 42 CFR 411.354(d)(1)(i), compensation is deemed set in advance if aggregate compensation, a time-based or per-use or per-service amount, or a specific formula is written before the compensated items, services, office space or equipment are furnished; the formula must permit objective verification. A modification qualifies only if all conditions in (d)(1)(ii) are met.
What if a required writing or signature is missing?
Under 42 CFR 411.354(e)(4), a compensation arrangement's writing or signature requirement under the Stark subpart is met if the arrangement otherwise fully complies with an applicable exception in that subpart and the parties obtain the required writings or signatures within 90 consecutive calendar days immediately after they were required but not obtained. This rule does not apply to writing modified compensation formulas under (d)(1)(ii)(C).
What happens when a lease expires and the payments continue?
For office-space leases, under 42 CFR 411.357(a)(7), a holdover immediately after a lease of at least 1 year satisfies paragraph (a) if (a)(1)–(6) were met at expiry. The holdover must retain the immediately preceding lease's terms and conditions and continue meeting (a)(1)–(6).
Is meeting a Stark exception enough for the Anti-Kickback Statute?
No. OIG's November 2023 guidance says the two are different laws requiring separate evaluations, and that an arrangement permissible under the Stark Law still needs its own Anti-Kickback analysis. The fair market value exception itself requires that the arrangement not violate the Anti-Kickback Statute (42 CFR 411.357(l)(5)).
What do fair market value and commercially reasonable mean in the Stark regulation?
Under 42 CFR 411.351, fair market value generally means the value in an arm's-length transaction, consistent with the general market value of the subject transaction. Commercially reasonable means the arrangement furthers a legitimate business purpose of the parties and is sensible considering the characteristics of the parties, including their size, type, scope and specialty.
Does IHS give legal opinions or contact CMS?
No. Your counsel decides whether an arrangement meets an exception or safe harbor, and your counsel and officers decide whether to self-disclose. IHS does not contact CMS, OIG or any other agency for you.