How to Avoid Corporate Integrity Agreements

Implement an effective compliance program, including regular compliance monitoring.

Implement an effective compliance program, including regular compliance monitoring.

The Office of Inspector General’s (OIG) Corporate Integrity Agreement list is one list you don’t want your healthcare organization—or any of its providers—to appear on. A corporate integrity agreement (CIA) is a document that outlines the obligations to which an entity agrees as part of a civil settlement for violations of the False Claims Act, Anti-Kickback Statute, Stark Law, or other policies and regulations. An entity agrees to the CIA obligations in exchange for the OIG’s agreement that it will not seek to exclude the entity from participation in Medicare, Medicaid, or other federal healthcare programs.

A comprehensive CIA typically lasts five years and includes requirements to hire a compliance officer/appoint a compliance committee; develop written compliance standards and policies; report overpayments, reportable events, and ongoing investigations/legal proceedings; and provide an implementation report and annual reports to OIG on the status of the entity’s compliance activities.

A Milwaukee pain management clinic and its physician owner agreed to pay at least $1.35 million to resolve allegations that they violated the False Claims Act and Anti-Kickback Statute by receiving kickbacks from a urine drug testing laboratory in exchange for ordering medically unnecessary tests for Medicare and Medicaid patients. Over more than five years, the clinic and its owner ordered thousands of unnecessary tests that were paid for by Medicare and Medicaid and received over $1 million in illegal kickbacks from the testing lab for ordering the tests. As part of the settlement, the clinic and physician entered into separate CIAs with the OIG to monitor ongoing compliance with Medicare and Medicaid rules.

A global pharmaceutical company recently agreed to pay the United States and state Medicaid programs $39 million to resolve allegations that it violated the False Claims Act and Anti-Kickback Statute by paying physicians kickbacks to prescribe its medications. The company allegedly paid physicians improper kickbacks in the form of speaker fees. Allegedly, payments were made to physicians even when physicians took turns “speaking” on duplicative topics over drug company-paid dinners, and when the recipient spoke only to members of his own staff in his own office. As part of the settlement, the pharmaceutical company entered into a CIA with the HHS-OIG that requires the drug company to undertake substantial internal compliance reforms for the next five years.

How to Avoid Regulatory Violations and CIAs

Healthcare organizations that get reimbursed by CMS with federal healthcare dollars for services need to take proactive steps to avoid regulatory violations and the resulting CIAs.

Develop an effective compliance program.

The best way to avoid a CIA is to implement a compliance program that includes these seven elements, recommended by the OIG:

  1. Designation of a compliance officer and compliance committee. The compliance department’s purpose is to implement the healthcare organization’s compliance program and to ensure that the organization complies with all applicable federal healthcare program requirements. To ensure that the compliance department is meeting this objective, each hospital should conduct an annual review of its compliance department.
  2. Development of compliance policies and procedures, Including standards of conduct. These written policies and procedures establish rules that help employees comply with federal healthcare program requirements.
  3. Developing open lines of communication. A culture that encourages open communication increases the organization’s ability to identify and respond to compliance problems. Hospitals should establish an anonymous hotline so that staff, contractors, patients, visitors, and medical and clinical staff members can report potential compliance issues.
  4. Appropriate training and education. Each employee and contractor needs to be fully capable of executing his or her role in compliance with rules, regulations, and other standards.
  5. Internal monitoring and auditing. Effective auditing and monitoring plans help organizations submit correct, compliant claims to federal healthcare program payers. You should develop detailed annual audit plans designed to minimize the risks associated with improper claims and billing practices. Create an electronic audit trail to prepare for external audits and compliance investigations. Accurate and up-to-date reporting is the key to audit readiness. Take advantage of automated compliance tools that build or schedule standard reports and send them to the appropriate parties. Monitor and report providers’ time and activities, gifts and other non-monetary compensation, and conflicts of interest to ensure compliance with the Anti-Kickback Statute and Stark Law.
  6. Response to detected deficiencies. You need to develop effective corrective action plans to respond to deficient, noncompliant processes and prevent further losses to federal healthcare programs.
  7. Enforcement of disciplinary standards. Enforcing disciplinary standards helps create a culture of ethical behavior.

Self-disclose violations of law related to the federal healthcare program. Report misconduct (e.g., kickbacks or fraudulent billing) that may violate criminal, civil, or administrative law to the appropriate federal or state authorities within 60 days. Prompt, voluntary reporting demonstrates your organization’s good faith and willingness to work with governmental authorities to correct the problem. Reporting misconduct will be considered a mitigating factor by the OIG in determining administrative sanctions (e.g., penalties, assessments, and exclusion) if the OIG investigates your organization.

Conduct exclusion screening for providers. OIG excludes individuals and entities from federally funded healthcare programs for a variety of reasons, including a conviction for Medicare or Medicaid fraud. Those that are excluded can receive no payment from federal healthcare programs for any items or services they furnish, order, or prescribe. Anyone who hires an individual or entity on the List of Excluded Individuals/Entities (LEIE) may be subject to civil monetary penalties (CMP). To avoid CMP liability, healthcare organizations should routinely check the list to ensure that new hires and current employees are not on it.

TractManager’s Compliance Suite helps healthcare organizations avoid regulatory violations and CIAs by identifying and resolving potential compliance risks before they occur. The four Compliance Suite modules—Provider Time Tracking, Gift Alert, Conflict of Interest Capture, and Pulse Check Vendor Survey—make it easy to monitor compliance; generate accurate reports for audit readiness; and automatically send reports to the appropriate parties. The Compliance Suite conducts exclusions verification through a module that incorporates the OIG file of excluded providers.

For more information on maintaining your healthcare contracting compliance, check out TractManager’s Compliance Suite.


Brooke Brown, RN, BSN

Vice President of Product Management

Brooke Brown joined TractManager’s Contract Management division in 2017


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