| name | stark-law-aks-compliance |
| title | Stark Law & AKS Compliance Plan |
| description | Drafts Stark Law and Anti-Kickback Statute compliance plans for healthcare organizations. Use when drafting physician self-referral compliance documents, AKS policies, healthcare fraud prevention frameworks, or arrangement-level risk assessments. |
| author | CaseMark |
| author_url | https://github.com/CaseMark/skills/tree/main/skills/legal/stark-law-aks-compliance |
| license | Apache-2.0 |
| version | 0.1.0 |
| execution_mode | open |
| jurisdiction | us |
| practice | healthcare |
| language | en |
| tags | ["checklist","drafting","memo","regulatory","research"] |
Stark Law & AKS Compliance Plan
Produces a defensible compliance plan covering physician self-referral prohibitions (Stark Law, 42 U.S.C. § 1395nn) and anti-kickback requirements (AKS, 42 U.S.C. § 1320a-7b(b)), tailored to the organization's arrangements and risk profile.
Prerequisites
- Organizational documents — corporate structure, service lines, covered entities
- Physician arrangement inventory — employment agreements, PSAs, medical directorships, leases, JV interests, recruitment packages
- Referral data — volume by physician, service type, payer
- Compliance history — audit findings, OIG/CMS correspondence, prior self-disclosures
- Compensation data — physician pay, FMV assessments, survey benchmarks
Quick Start
- Gather prerequisites above
- Inventory all physician financial arrangements
- Score each arrangement using the risk matrix (Section III)
- Map each arrangement to a Stark exception and AKS safe harbor
- Draft plan sections I–X below
- Run the pitfall checklist before finalizing
Core Workflow
I. Scope & Authority
Define: covered entities (all system legal entities), covered personnel (employees, contractors, medical staff, board), covered relationships (all financial arrangements with referral sources), DHS trigger (any designated health service under § 1395nn), and authority basis (board resolution with date).
II. Regulatory Framework
Stark Law (42 U.S.C. § 1395nn; 42 C.F.R. § 411.350–.389)
- Prohibits physician self-referrals for DHS when financial relationship exists
- Strict liability — no intent requirement
- Penalties: claim denial, refunds, CMPs up to $100k/arrangement, FCA exposure
DHS categories — map to org's actual service lines: clinical lab, PT/OT/speech, radiology/imaging, radiation therapy, DME, home health, outpatient Rx, inpatient/outpatient hospital.
Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b); 42 C.F.R. § 1001.952)
- Criminal prohibition on remuneration to induce referrals
- "One purpose" test — any intent to induce suffices
- Penalties: felony (up to 5 yrs), $100k CMP/violation, treble damages, exclusion
Key Safe Harbors (42 C.F.R. § 1001.952):
| Safe Harbor | Critical Elements |
|---|
