HHS Office of Inspector General Releases 2014 Work Plan: New Items Relevant to Prescription Drugs

On February 6, 2014, the U.S. Department of Health & Human Services (“HHS”) Office of Inspector General (“OIG”) released its annual 2014 Work Plan. In addition, the OIG has posted a 25-minute video vignette featuring senior OIG executives discussing the OIG’s top priorities for fiscal year 2014. The OIG annually publishes a Work Plan that summarizes new and ongoing reviews and activities that OIG plans to pursue during the applicable fiscal year. Among other things, the 2014 Work Plan includes a number of new items (since the 2013 Work Plan) relevant to prescription drugs, including the following proposed audits:

  • Manufacturer reporting of average sales prices for Part B drugs“We will determine the potential effect on average sales price reporting if all manufacturers of Part B-covered drugs were required to submit ASPs to CMS. We will also determine whether CMS has improved its process for collecting ASP data, as we previously recommended.”
  • Part B payments for drugs purchased under the 340B Program
  • “We will determine how much Medicare Part B spending could be reduced if Medicare were able to share in the savings for 340B-purchased drugs.”
  • Covered uses for Medicare Part B drugs
  • “We will review the oversight actions CMS and its claims processing contractors take to ensure that payments for Part B drugs meet the appropriate coverage criteria. We will also identify challenges contractors face when making coverage decisions for drugs.”
  • Payment for compounded drugs under Medicare Part B
  • “We will examine MACs’ policies and procedures for reviewing and processing Part B claims for compounded drugs and assess the appropriateness of such claims.”
  • Comparison of Medicare Part D and Medicaid pharmacy reimbursement and rebates
  • “This review, which is a followup to previous work, will compare pharmacy reimbursement and rebate amounts for a sample of brand-name drugs paid by Medicare Part D and by Medicaid.”