Mandatory Self-Reporting Remains in Play
The Centers for Medicare and Medicaid Services (CMS) released its final rule affecting the Medicare Advantage and Medicare Prescription Drug Benefit Programs that imposes significant changes on the legal and operational obligations of participating plans.
These changes will affect not only sponsors of Medicare Advantage and Medicare Part D plans (Plan Sponsors) but also providers and pharmacy benefit managers (PBMs) with whom Plan Sponsors contract, pharmaceutical manufacturers and other contractors involved in the Medicare Advantage and Prescription Drug Benefit Programs.
Examples of significant provisions of the final rule include the following:
CMS deferred action on a proposed requirement that Plan Sponsors self-report potential fraud and misconduct. Rather, CMS adopted regulatory language recommending that Plan Sponsors “have procedures for voluntary self-reporting of potential fraud or misconduct.” CMS also indicated its commitment to adopting mandatory self-reporting in the future and solicited industry comment on key issues for constructing such a requirement.
Effective January 1, 2008, Plan Sponsors will be required to incorporate compliance measures that extend to their contracted providers and administrative services contractors. CMS clarified that its authority to inspect, evaluate and audit the books and records of Plan Sponsors’ first-tier and downstream entities extends to the ultimate providers of health care, prescription drug and administrative services. CMS also specified that this authority includes the ability to review “any records relating to rebates and other price concessions…that may impact payments made to sponsors in the Part D program.”
The final rule will be published in the Federal Register on December 5, 2007.