Healthcare attorneys spend 12+ hours researching current Stark Law and Anti-Kickback regulations, reviewing OIG guidance, drafting comprehensive compliance plans, and ensuring all required sections meet CMS standards. Manual drafting requires constant verification of regulatory updates, citation accuracy, and alignment with best practices from multiple authoritative sources.
Healthcare organizations face severe penalties for Stark Law and Anti-Kickback Statute violations, with fines reaching millions and potential criminal liability. Manually drafting comprehensive compliance plans requires 40+ hours of specialized legal expertise, extensive regulatory research, and careful tailoring to organizational risk profiles. Most healthcare entities lack the resources to create defensible compliance frameworks that withstand government scrutiny.
CaseMark automates the creation of comprehensive, federally-compliant Stark Law and Anti-Kickback Statute compliance plans in under 30 minutes. Our AI analyzes your organizational documents, current physician arrangements, and referral patterns to generate tailored compliance frameworks with risk assessments, operational policies, monitoring protocols, and audit procedures that meet CMS and OIG standards.
This workflow is applicable across multiple practice areas and use cases
Healthcare M&A transactions require comprehensive Stark Law and Anti-Kickback compliance assessments as part of due diligence and post-merger integration to avoid regulatory violations and penalties.
Acquiring or merging healthcare entities must evaluate existing physician arrangements and referral relationships for compliance risks, making this workflow essential for transaction structuring and risk mitigation.
Healthcare employment and consulting agreements with physicians must comply with Stark Law safe harbors and Anti-Kickback exceptions, requiring careful drafting of compensation arrangements and referral provisions.
Physician employment contracts and consulting arrangements are high-risk areas for Stark Law violations, making compliance analysis essential when drafting or reviewing these agreements.
Healthcare organizations need board-level compliance programs and governance frameworks that address Stark Law and Anti-Kickback requirements as part of their fiduciary duties and corporate compliance obligations.
Corporate governance for healthcare entities requires establishing and maintaining compliance programs that meet OIG's Seven Elements, making this workflow directly applicable to governance documentation and board oversight.
New healthcare entities, physician groups, and medical practices must establish Stark Law and Anti-Kickback compliance frameworks from inception to ensure proper structuring of physician arrangements and referral relationships.
Healthcare startups and new medical practices need compliant organizational structures and policies before commencing operations, making this workflow valuable for initial compliance program development.
A defensible compliance plan must demonstrate proactive risk assessment, comprehensive policies addressing all applicable exceptions and safe harbors, systematic monitoring and auditing procedures, and documented training programs. The plan should cite current regulatory authorities, include specific operational procedures rather than vague aspirations, and show evidence of ongoing implementation through audit trails and corrective actions. CaseMark generates plans that incorporate these essential elements based on OIG compliance program guidance and current CMS regulations.
Compliance plans should be reviewed annually at minimum and updated immediately when significant regulatory changes occur, such as new Stark Law exceptions or Anti-Kickback safe harbors. Updates are also necessary when your organization undergoes operational changes like mergers, new service lines, or significant physician arrangement modifications. CaseMark enables rapid plan updates by regenerating sections affected by regulatory or organizational changes while maintaining consistency across the document.
CaseMark requires your organizational structure documents and existing physician financial arrangements to generate a tailored plan. Optional documents like referral data, previous audit reports, and fair market value assessments enable more sophisticated risk analysis and targeted policies. The AI analyzes these materials to identify your specific compliance risks, applicable exceptions and safe harbors, and operational context, producing a plan that addresses your actual arrangements rather than generic templates.
Yes, CaseMark-generated compliance plans are designed to demonstrate good faith compliance efforts during government scrutiny. The plans include detailed regulatory citations, comprehensive risk assessments, specific operational procedures, and evidence of systematic monitoring—all elements that government auditors and prosecutors evaluate when assessing compliance programs. However, the plan's effectiveness depends on actual implementation, so organizations must follow the policies, conduct required training, and maintain documentation as specified in the plan.
Unlike generic templates, CaseMark analyzes your uploaded organizational documents to identify your specific physician arrangements, referral patterns, service lines, and risk factors. The AI generates customized risk assessments, tailored policies addressing your actual business relationships, and monitoring procedures focused on your highest-risk areas. The result is a compliance plan that reflects your operational reality and regulatory profile rather than a one-size-fits-all document requiring extensive manual customization.