Often a health care provider finds itself under government investigation for alleged wrongdoing related to a federal health care program, such as Medicare or Medicaid. The Office of Inspector General for the Department of Health and Human Services (HHS-OIG) may be a part of the investigation. To resolve an investigation instead of litigating, the provider is often required to implement a Corporate Integrity Agreement (“CIA”). Under a CIA, the provider consents to take certain compliance measures. The measures are intended to remedy the problematic practices that were uncovered during the government’s investigation. In exchange for agreeing to the terms of the CIA, HHS-OIG may agree not to seek to exclude the provider from the federal health care programs. The HHS-OIG has such authority to exclude providers for certain conduct under 42 U.S.C. §1320a-7.
Each CIA is tailored to the company and conduct at issue. However, a provider should anticipate the CIA will typically include some standard provisions. First, the provider likely will need to put in place a compliance officer (or strengthen the support of an existing one) and/or a compliance committee. Second, the CIA usually requires training and education that is tailored to the federal program and the people who oversee it. Third, the company may need to establish or strengthen existing written compliance policies and procedures. Fourth, the company will need review procedures to determine whether its compliance practices are effective. Fifth, the company will be required to have a disclosure program and to make future voluntary disclosures of overpayments and potential violations of civil, criminal or administrative laws. Last, the company should expect to submit quarterly or annual reports of its compliance efforts, among other reporting and review requirements.
How can Finch McCranie assist a company that is required to enter a CIA?
The CIA may require the company to retain an Independent Review Organization (“IRO”). An IRO is an auditing or consulting firm that provides independent and objective reviews. The types of reviews that an IRO must conduct may include both reviews of the systems the company has put in place, as well as reviews of individual claims, as in the case of a provider that is responsible to submit Medicare and Medicaid claims.
Finch McCranie can assist the company with selecting a competent and specialized IRO. It is in the provider’s best interest to select a highly qualified IRO. Though retained and compensated by the company, the IRO is accountable to the HHS-OIG. For example, the HHS-OIG retains certain rights under the IRO. The HHS-OIG is responsible to approve the IRO, and will have access to the IRO’s workpapers and the communications between the IRO and the provider. The HHS-OIG retains the right to meet with the IRO to question and perform a validation review of the work of the IRO. Further, the HHS-OIG has the right to require the replacement of an insufficient or ineffective IRO.
Finch McCranie’s attorneys can lead an IRO team. To illustrate, Renée Brooker spent the better part of her federal career in a senior position at the United States Department of Justice in Washington, D.C. Most recently, as Assistant Director for Civil Frauds, she was responsible for civil enforcement efforts involving corporations and individuals. Ms. Brooker’s direct and strategic oversight of some of the Justice Department’s highest stakes civil cases led to billions of dollars in Department of Justice recoveries. She received numerous and high-level honors for her significant accomplishments, including the Attorney General’s award for fraud prevention involving Medicare and Medicaid drug pricing fraud.
Eva Gunasekera spent nearly nine years in the Justice Department and rose to become the Civil Division’s Senior Counsel for Health Care Fraud. She has extensive experience resolving the alleged fraudulent practices of health care providers, including physician groups, managed care providers, and hospice and nursing home providers, as well as pharmaceutical manufacturers, durable equipment manufacturers, and pharmacies.
Finch McCranie’s partners are each former federal prosecutors with more than 30 years of experience. Each has performed internal investigations and provided advice on compliance issues to businesses.
With the guidance of Finch McCranie counsel and an outside specialized team, our attorneys can assess and oversee a company’s compliance with applicable laws relevant to the environment in which the company operates. We can help to ensure that the company and its employees operate legally and ethically, thereby minimizing or eliminating recurring liability.
In short, we can assist the company to retain, work with, and oversee the IRO. Our attorneys can provide a full range of services to any provider in the health care industry that finds itself subject to a CIA. With decades of experience conducting federal investigations of health care companies on behalf of the Justice Department, our attorneys have deep knowledge and experience of federal health care investigations that lead to the imposition of a CIA. We can ensure the company complies with all federal and state health care laws, Medicare and Medicaid reimbursement laws, anti-kickback and self-referral laws, and privacy laws.