The OIG released its Work Plan for the 2010 fiscal year, to be effective beginning October 2009. The OIG's Work Plan "describes the specific audits and evaluations that [the OIG has] underway or plan[s] to initiate in the FY ahead . . . The Work Plan also provides focus areas for [the OIG's] investigative, enforcement, and compliance activities."
A few notable areas of focus and scrutiny include the OIG's plans to
- review Medicare payments for drugs and biologicals used on an off-label basis in anticancer chemotherapeutic regimens;
- review contracted pharmaceutical manufacturer rebates collected by Part D sponsors and pharmacy benefit managers (PBMs);
- review the adequacy of the FDA's complaint investigation process;
- review selected drug manufacturers to evaluate the methodologies they use to calculate their average manufacturer prices (AMPs), and the best price for the Medicaid drug rebate Program and for Medicaid drug reimbursement purposes;
- review the extent to which drug manufacturers use foreign clinical trials to support new drug applications and biological licensing agreements submitted to FDA;
- review FDA's oversight and operations related to imported pet food and feed products;
- review FDA's oversight of food facility inspections conducted on behalf of FDA by states through contracts and partnership agreements;
- review FDA's food facility inspection process and its methods for selecting facilities for inspection;
- review FDA's process for evaluating investigational new drug applications; and
- review the extent to which the FDA oversees blood establishments to ensure the safety of the nation's blood supply.
The 128-page Work Plan outlines an ambitious set of goals for FY2010. The increased scrutiny and focus on these FDA-related processes and areas is likely to trickle down to these segments of the industry as well.