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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.
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Use when retrieving arbitration institutional rules (ICC, LCIA, SCC, SIAC, HKIAC, VIAC, МКАС/МАК при ТПП України, UNCITRAL) — fetching current version, verifying redaction applicable to the date of arbitration agreement, constructing URLs for official rule texts
Use when choosing the Polish legal regime for letters, requests, applications, complaints, petitions, public-information requests, KPA filings, PPSA complaints, RODO access requests, registry extracts, court-file access, tax/ZUS/cudzoziemcy/USC procedures, or professional lawyer letters. Prevents mixing UDIP, KPA, PPSA, RODO, registry, special-procedure, and advocate/radca letter regimes.
Use when preparing applications for recognition and enforcement of foreign arbitral awards in Poland, applications for setting aside arbitral awards under KPC art. 1205–1211, or opposing such applications — mapping Article V of the 1958 New York Convention to art. 1214–1215 of the Polish KPC, identifying grounds for refusal, structuring public policy arguments
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| 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"] |
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.
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).
Stark Law (42 U.S.C. § 1395nn; 42 C.F.R. § 411.350–.389)
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)
Key Safe Harbors (42 C.F.R. § 1001.952):
| Safe Harbor | Critical Elements |
|---|
| Employment | ≥1 yr, FMV, not volume/value-based, commercially reasonable |
| Personal services | Written agreement, specific services, ≥1 yr, FMV, aggregate set in advance |
| Space rental | Written agreement, specific space, ≥1 yr, FMV, not volume/value-based |
| Equipment rental | Written agreement, specific equipment, ≥1 yr, FMV, not volume/value-based |
| Practitioner recruitment | Written agreement, underserved area benefit, net cost to practice |
Arrangement inventory — catalog: employed physicians, independent contractor PSAs, medical directorships, physician ownership/JV interests, space/equipment leases, recruitment incentives, call coverage, research collaborations with referral overlap.
Risk scoring matrix:
| Factor | High (3) | Medium (2) | Low (1) |
|---|---|---|---|
| Referral volume | Top decile | Average | Minimal |
| DHS dollar value | >$500k/yr | $100k–$500k | <$100k |
| Compensation variability | Volume-linked | Partially variable | Fixed only |
| FMV verification | >24 mo stale | 12–24 mo | <12 mo current |
| Written agreement | Missing/expired | Gaps in terms | Fully compliant |
Referral pattern analysis: compare per-physician volumes to peer benchmarks; flag post-arrangement spikes >20%; identify exclusive referral patterns; validate utilization against clinical norms.
Arrangement lifecycle:
| Phase | Requirement |
|---|---|
| Pre-execution | Submit to compliance ≥30 days before effective date |
| Content | Parties, services, time commitment, specific compensation, term dates, termination provisions |
| FMV threshold | Third-party valuation if >$50k/yr OR high referral volume |
| Execution | Signed before services begin or compensation paid |
| Annual review | Verify compliance, FMV currency, services rendered |
| Renewal | Re-assess ≥60 days before expiration |
Prohibited practices: productivity bonuses tied to DHS volume; per-click leases varying with referred-patient use; director stipends fluctuating with referrals; above/below-FMV rental rates; free/discounted services to referral sources; undocumented recruitment guarantees.
| Audience | Timing | Focus |
|---|---|---|
| All employees | Hire + annual | Basic framework, reporting obligations |
| Physician contracting | Quarterly | Arrangement structuring, exceptions/safe harbors |
| Business development | Quarterly | Relationship ID, prohibited inducements |
| Billing/coding | Semi-annual | DHS claim requirements |
| Physicians | Onboarding + annual | Personal liability, referral restrictions |
| Compliance staff | Ongoing | Regulatory updates, enforcement trends |
Require scenario-based assessments, passing score threshold, documented attendance.
Continuous monitoring: automated tracking of referral volumes, compensation payments, utilization rates, contract expirations. Alert on volume breaches, >20% pattern deviations, approaching expirations.
Annual internal audit (risk-based sampling, weight toward high-risk):
External review: every 3 years minimum, or after mergers, enforcement actions, major regulatory changes.
Channels: third-party hotline (24/7, multilingual), compliance email, physical mail, intranet portal, in-person to compliance/HR.
Non-retaliation policy — covers termination, demotion, pay reduction, schedule changes, hostile environment.
Triage:
| Severity | Criteria | Response |
|---|---|---|
| Critical | Ongoing violation, significant financial/safety risk | Immediate investigation, suspend arrangement |
| High | Systemic compliance failure | Expedited investigation (30 days) |
| Standard | Isolated potential violation | Standard investigation (60 days) |
Corrective actions: terminate/restructure non-compliant arrangements, recover overpayments, discipline responsible individuals, enhance controls, self-disclose when required (OIG Self-Disclosure Protocol / CMS SRDP), verify implementation.
Per-arrangement file: executed agreement + amendments, FMV analysis with methodology, board/committee approval minutes, compliance review certification, evidence of services rendered, compensation records, correspondence, annual review documentation.
Retention: minimum 10 years from last service/payment; longer if litigation/investigation pending. Secure storage with role-based access.
| Role | Responsibilities |
|---|---|
| Compliance Officer | Day-to-day oversight, direct board access, authority to challenge business decisions |
| Compliance Committee | Quarterly review of findings, corrective actions, regulatory developments |
| Board of Directors | Ultimate oversight, annual effectiveness review, resource allocation |
Annual program review: policy currency, monitoring effectiveness, training outcomes, reporting utilization, benchmark against OIG guidance and HCCA standards.
Regulatory change protocol: monitor CMS/OIG final rules, advisory opinions, enforcement actions → draft amendment → legal review → Committee → Board → communication/training.
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