ASC Corporate Compliance & Stark Law / Anti-Kickback Risk Management

ASC Corporate Compliance & Stark Law / Anti-Kickback Risk Management

The compliance landscape for ambulatory surgery centers is shaped significantly by the physician ownership model that characterizes most independent ASCs. Physician investors in ASCs that perform procedures on their own Medicare patients must meet the requirements of the whole hospital exception to the Stark Law — which requires, among other things, that the investment opportunity be offered on the same terms to all investors, that the ASC meet certain Medicare billing and quality standards, and that the percentage of the total volume of procedures performed by physician investors not exceed certain thresholds in some state settings.

Beyond the ownership structure, ASC billing compliance involves specific risk areas — including the correct application of the Medicare ASC fee schedule, appropriate modifier usage, implant billing compliance, and the documentation requirements that support the procedural codes billed. And the movement toward more complex, higher-value procedures in the ASC setting has increased the stakes of billing compliance — because the dollar amounts involved in higher-acuity procedure billing create greater False Claims Act exposure when billing errors occur.

Stark Law & Whole Hospital Exception Compliance

• Physician Ownership Structure Review — Evaluation of ASC physician ownership arrangements for compliance with the Stark Law whole hospital exception, including investment offer requirements, proportional return on investment standards, and Medicare billing and quality condition requirements, with identification of noncompliant structures and remediation planning

• Investment Opportunity Documentation — Development and documentation of physician investment offering processes to demonstrate equal access and consistent terms across physician and non-physician investors, supporting compliance with applicable regulatory requirements under the whole hospital exception framework

• Physician Compensation Arrangements — Review and compliance assessment of all physician financial relationships with the ASC, including medical director agreements, administrative service contracts, equipment leases, and call coverage payments, evaluated under Stark Law requirements and applicable Anti-Kickback Statute safe harbors

Corporate Compliance Program Development

• ASC Corporate Compliance Program Development — Design and implementation of ASC-specific compliance programs aligned with all seven OIG compliance program elements, tailored to ambulatory surgery operations

• Written Compliance Policies & Procedures — Development of comprehensive policies covering billing compliance, physician financial arrangements, patient privacy, documentation standards, and staff conduct expectations

• Compliance Officer Structure — Establishment and definition of compliance officer role, including authority, reporting structure, independence, and oversight responsibilities

• Role-Specific Compliance Training — Development of targeted training programs for clinical staff, billing and coding personnel, administrative teams, and physician investors focused on ASC regulatory requirements and risk areas

• Anonymous Reporting & Hotline Systems — Implementation of confidential compliance reporting mechanisms with structured intake, tracking, and investigation workflows for reported concerns

• Annual Compliance Audit Plan — Creation of structured audit schedules covering billing and coding accuracy, medical documentation integrity, physician arrangement compliance, and credentialing processes

• Disciplinary Standards & Enforcement Framework — Establishment of consistent disciplinary policies for compliance violations, ensuring uniform application across all staff and physician groups

• Issue Response & Self-Disclosure Protocols — Development of response procedures for identified compliance issues, including investigation workflows, corrective action planning, and evaluation of voluntary self-disclosure requirements