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.
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.
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.
Annual program review: policy currency, monitoring effectiveness, training outcomes, reporting utilization, benchmark against OIG guidance and HCCA standards.
Stark exceptions are mandatory — if no exception applies, the arrangement violates the statute regardless of intent
AKS safe harbors are voluntary — failure to meet one doesn't automatically establish violation, but arrangement must still lack improper intent
Cite specific statutory provisions throughout (§ 1395nn, § 1320a-7b(b), 42 C.F.R. § 411.357, § 1001.952)
Use directive language ("must," "shall") — not aspirational ("should generally")
Address state-level self-referral and anti-kickback statutes where applicable
Include CMS SRDP and OIG Self-Disclosure Protocol procedures
Verify all regulatory citations are current before finalizing [VERIFY]
Tailor DHS categories, safe harbors, and examples to the organization's actual service lines
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