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Stark Law Aks Compliance

Draft Stark Law & AKS Compliance Plans in Minutes

14 minutes with CaseMark

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Stark Law Aks Compliance

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Stark Law Aks Compliance

Overview

CaseMark's Stark Law & AKS Compliance skill generates comprehensive, defensible compliance plans that address physician self-referral prohibitions and anti-kickback requirements tailored to your healthcare organization. The AI analyzes your physician financial arrangements, scores each for regulatory risk, and maps them to applicable exceptions and safe harbors. The result is a board-ready compliance plan covering policies, training, monitoring, and remediation across all designated health service lines.

Drafting Stark Law and Anti-Kickback Statute compliance plans is one of the most complex and time-intensive tasks in healthcare regulatory law. Organizations must inventory dozens or hundreds of physician financial arrangements, evaluate each against intricate exception and safe harbor requirements, assess FMV compensation, and produce documentation that can withstand OIG and CMS scrutiny. Manual preparation often takes weeks of attorney and compliance officer time, and gaps in analysis can expose organizations to significant civil and criminal liability.

CaseMark automates the heavy lifting of Stark Law and AKS compliance plan drafting by analyzing your organizational documents and physician arrangement inventory against the full regulatory framework. The AI generates a structured, multi-section compliance plan with arrangement-level risk scoring, exception and safe harbor mapping, and actionable remediation recommendations. This allows healthcare compliance teams and attorneys to focus their expertise on strategic judgment rather than document assembly.

How it works

  1. 1. Upload your organizational documents, physician arrangement inventory, and compliance history

  2. 2. AI analyzes arrangements against Stark Law exceptions and AKS safe harbors, scoring each for risk

  3. 3. Review the generated compliance plan with arrangement-level risk assessments and remediation guidance

  4. 4. Export your finalized compliance plan in your preferred format (DOCX, PDF)

What you get

  • Scope & Authority Definition

  • Regulatory Framework Analysis

  • Physician Arrangement Inventory & Risk Matrix

  • Stark Exception & AKS Safe Harbor Mapping

  • FMV Compensation Analysis

  • Referral Data Assessment

  • Compliance Policies & Procedures

  • Training & Education Requirements

  • Monitoring & Auditing Framework

  • Pitfall Checklist & Remediation Plan

What it handles

  • Comprehensive regulatory framework mapping for Stark Law and AKS requirements

  • Arrangement-level risk scoring with exception and safe harbor mapping

  • Physician financial arrangement inventory and analysis

  • FMV compensation benchmarking and documentation guidance

  • Pitfall checklist and self-disclosure readiness assessment

  • Customized compliance plan sections tailored to your organization's service lines

Required documents

  • Organizational Documents

    Corporate structure charts, service line descriptions, and covered entity identification documents

    .pdf, .docx

  • Physician Arrangement Inventory

    Employment agreements, personal services agreements, medical directorships, leases, joint venture interests, and recruitment packages

    .pdf, .docx, .xlsx

  • Compliance History

    Prior audit findings, OIG/CMS correspondence, self-disclosure records, and corrective action plans

    .pdf, .docx

Supporting documents

  • Referral Data

    Physician referral volume data by service type, payer, and time period

    .pdf, .xlsx, .csv

  • Compensation Data & FMV Assessments

    Physician compensation schedules, fair market value appraisals, and survey benchmarks

    .pdf, .docx, .xlsx

  • Board Resolutions

    Board resolutions authorizing the compliance program and designating compliance officers

    .pdf, .docx

Why teams use it

Reduce compliance plan drafting time from weeks to hours while maintaining thoroughness and defensibility

Identify high-risk physician arrangements with structured risk scoring and prioritized remediation guidance

Ensure comprehensive coverage of all Stark exceptions and AKS safe harbors applicable to your specific arrangements

Strengthen your organization's compliance posture with built-in pitfall checklists and self-disclosure readiness assessments

Questions

What types of physician arrangements does this compliance plan cover?

CaseMark analyzes all physician financial arrangements including employment agreements, personal services agreements, medical directorships, space and equipment leases, joint venture interests, and recruitment packages. Each arrangement is mapped to applicable Stark exceptions and AKS safe harbors.

How does the AI handle the risk assessment for each arrangement?

CaseMark uses a structured risk matrix that scores each physician financial arrangement based on factors like compensation structure, FMV alignment, referral volume patterns, and documentation completeness. High-risk arrangements are flagged with specific remediation recommendations.

Is the generated compliance plan sufficient for OIG or CMS scrutiny?

CaseMark generates a comprehensive, defensible compliance plan framework aligned with OIG guidance and CMS requirements. However, the output should be reviewed by qualified healthcare compliance counsel to ensure it fully addresses your organization's specific circumstances and regulatory obligations.

Can this tool help with self-disclosure preparation?

Yes. CaseMark's compliance plan includes a pitfall checklist and self-disclosure readiness assessment that identifies potential violations requiring disclosure. This gives your compliance team a head start on evaluating whether arrangements warrant CMS self-referral disclosure protocol or OIG self-disclosure submissions.

How does CaseMark handle the different DHS categories under Stark Law?

CaseMark maps your organization's actual service lines to all designated health service categories under 42 U.S.C. § 1395nn, including clinical lab, imaging, physical therapy, DME, home health, and hospital services. This ensures no referral relationship is overlooked in the compliance analysis.

How current is the regulatory analysis provided by CaseMark?

CaseMark's analysis incorporates the current Stark Law regulations (42 C.F.R. § 411.350–.389) and AKS safe harbors (42 C.F.R. § 1001.952). We recommend verifying against the most recent CMS and OIG guidance, as regulations are subject to change through rulemaking and advisory opinions.

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