Corporate Integrity Agreements: What Are the Health Provider's Obligations?
Wednesday, November 8, 2023
By Michelle E. Missigman, J.D.
For corporate health care providers involved in a civil health care fraud or abuse investigation, the corporation may be required to enter into a Corporate Integrity Agreement (CIA) with the U.S. Department of Health and Human Services (HHS), Office of Inspector General (OIG) to settle the case. This is an agreement with significant legal implications that requires serious scrutiny and must be followed to the letter.
What Is a Corporate Integrity Agreement?
A CIA is a document outlining the obligations to which a corporate provider agrees as part of a civil settlement, usually of charges under the False Claims Act (FCA). CIAs are an enforcement tool used by the OIG and the Department of Justice (DOJ) to help fight health care fraud, waste, and abuse. The government can use CIAs to address quality of care and program integrity issues. CIAs generally last five (5) years. Click here to view the Corporate Integrity Agreement Snapshot from CMS.
By entering into a CIA, a corporate provider agrees to the obligations in the CIA in exchange for the OIG’s agreement not to exclude the provider from participating in Medicare, Medicaid, or other Federal health care programs. If the corporate healthcare provider wants to continue doing business, it often has little or no choice but to accept the obligations as outlined in the CIA.
A material breach of the CIA is enough to place the corporate provider on the OIG's List of Excluded Individuals and Entities (LEIE), preventing the provider from participating in any Federal health care program (often called a "death sentence").
What Are the Requirements of a Corporate Integrity Agreement (CIA)?
The CIA often includes requirements to:
1. Hire a compliance officer or appoint a compliance committee;
2. Develop written standards and policies;
3. Implement a comprehensive employee training program;
4. Retain an independent review organization to conduct annual reviews;
5. Establish a confidential disclosure program;
6. Restrict employment of ineligible persons;
7. Report overpayments, reportable events, and ongoing investigations/legal proceedings; and
8. Provide an implementation report and annual reports to OIG on the status of the company's compliance activities.
The CIA places a heavy burden on the corporation's resources and expenses to maintain compliant with its terms. Hiring a competent and knowledgeable attorney to guide you is a key part of the process in order to fully understand the CIA and ensure that you abide by its terms.
If your corporation is considering entering into a CIA, you must understand the obligations and burdens that will be imposed upon it. This will help the provider corporation become successful in staying in compliance throughout the term of the agreement.
Contact Experienced Health Law Attorneys.
The Health Law Firm routinely represents physicians and medical groups on EHR issues. It also represents pharmacists, pharmacies, physicians, nurses and other health providers in investigations, regulatory matters, licensing issues, litigation, inspections and audits involving the DEA, Department of Health (DOH) and other law enforcement agencies. Its attorneys advise on legal and regulatory matters involving health professionals and health facilities. Its attorneys include those who are board certified by The Florida Bar in Health Law as well as licensed health professionals who are also attorneys.
To contact The Health Law Firm, please call (407) 331-6620 or toll free at (888) 331-6620 and visit our website at www.TheHealthLawFirm.com.
About the Author: Michelle E. Missigman, is a health attorney practicing with The Health Law Firm. The firm has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Suite 1000, Altamonte Springs, FL 32714, Phone: (407) 331-6620 or Toll-Free: (888) 331-6620.
Current Open Positions with The Health Law Firm. The Health Law Firm always seeks qualified individuals interested in health law. Its main office is in the Orlando, Florida, area. If you are a current member of The Florida Bar or a qualified professional who is interested, please forward a cover letter and resume to: KBrant@TheHealthLawFirm.com or fax them to (407) 331-3030.
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