OIG Mid-Year Work Plan Now Includes Medicare Part D, Medicaid Rebate Reviews

HHS’ Office of Inspector General has added four new projects to its 2015 work plan, including the creation of a Medicare Part D oversight portfolio and a review of states’ reporting on Medicaid rebate collections.

The oversight portfolio will summarize OIG audits, legal opinions and investigative work on the Medicare Part D prescription drug program and provide recommendations to improve it. Since Part D’s inception, OIG has identified weaknesses in the program, including oversight by sponsors and CMS, the workplan says.

The office will also review states’ reporting of the federal share of Medicaid rebate collections to determine if they are correctly identifying and reporting increases. The Affordable Care Act increased Medicaid drug rebates for outpatient drugs and requires that the additional monies be given to the federal government.

The updated workplan also calls for OIG to analyze drug prices to determine if they increased faster than inflation, as measured by the consumer price index for urban consumers. Under the Medicaid drug rebate program, manufacturers must pay an additional rebate for brandname drugs that increase more than the CPI-U.

Lastly, OIG will review manufacturers’ treatment of sales of authorized generics in their calculations for the Medicaid drug rebate program to determine if sales to secondary manufacturers are lowering the average manufacturer price and decreasing rebates paid to states.

The annual work plan released last November focused on auditing FDA inspections of generic drug facilities, overseeing postmarketing studies and ensuring compliance with clinical trial reporting.

The mid-year update, released last week, is available at www.fdanews.com/06-15-workplan.pdf. — John Bechtel