It's an all-too-common scenario —
On November 22, 2013 CVS/Caremark entered into a settlement and a Corporate Integrity Agreement (CIA) with the United States government. The agreements followed allegations that CVS knowingly submitted false claims to various participating State Medicaid programs, resulting in higher reimbursements than they were owed. CVS agreed to pay $4.25 million, and to comply with the terms of the CIA to avoid exclusion from participation in Federal healthcare programs.
Long before this case, CVS was already subject to a corporate compliance program. Obviously, the effectiveness of that program is debatable. While the government acknowledges there was a program in place, several additional requirements were necessary to improve the effectiveness of the program.
When it comes to compliance policies and procedures, CVS (like any other pharmacy) is required to address Pharmacy Benefit Manager (PBM) operations to process third-party liability claims, in line with all Federal healthcare regulations. These regulations — along with other statutes, applicable case law, and written directives — govern a pharmacy's participation in the Federal healthcare program. The corporate integrity agreement mandates specific requirements for distribution, review, revision and training, with respect to the relevant policies and procedures.
Avoiding a "CVS situation" is equal parts common sense and, more importantly, having and adhering to effective compliance Standards and Procedures. Gauge your effectiveness by asking a few key questions:
Are our Standards and Procedures appropriately written to address relevant compliance issues?
Are we communicating and training these standards to all Covered Persons whose job functions relate to such standards and procedures?
Are knowledgeable staff available to explain and clarify policies and procedures?
Are we monitoring the effectiveness of our processes?
So go ahead — ask these questions, save yourself millions, and avoid being the next headline!