Enforcement Response, Corrective Action Plans, and Government Investigations
Responding to Government Requests
Common instruments include subpoenas for documents or testimony, civil investigative demands, OCR inquiries, and OIG exclusion inquiries. Route the request to counsel, designate a single point of contact, log every deadline, issue a preservation notice, and produce documents in the requested format. Never alter, backdate, or destroy records - obstruction converts a civil matter into a criminal exposure.
Cooperation and Disclosure
The Justice Department's guidance on evaluation of corporate compliance programs and its False Claims Act cooperation guidance reward voluntary self-disclosure, thorough remediation, and genuine cooperation, and reduce credit for non-cooperation. The OIG Self-Disclosure Protocol can resolve disclosed conduct, frequently with a corporate integrity agreement rather than exclusion.
Corrective Action Plans
A defensible CAP includes root-cause analysis, specific corrective actions, named owners and due dates, monitoring and auditing to verify the fix, reporting to the governing body, and documented closure. Regulators reject CAPs that consist only of re-training; effective CAPs address the system that permitted the failure - contract review, template design, pre-bill edits, oversight, or staffing.
Corporate Integrity Agreements
Common CIA terms include a compliance officer and committee, board oversight, written standards, training, a hotline, annual audits, independent review organization reviews, certifications of compliance by executives and the board, reporting obligations, stipulated penalties, and breach provisions.
Traps
A CAP closed with undated or undocumented verification will not withstand scrutiny. Exclusion is mandatory for certain program-related convictions and permissive for others; know that distinction. Settlement does not end the obligation to remediate.
Worked Example
After discovering billing for services ordered by an excluded physician, the CAP should include repayment, screening controls at the front end, retrospective claims review, monitoring, and board reporting.