• Insight
  • Medicare Coverage Gap Discount Program Guidance Beginning in 2011
  • CMS Proposed 2011 Policies and Payment Rates for Inpatient Services
  • CMS Issues Final 2011 Payment Policies for Medicare Advantage and Prescription Drug Plans
  • OPPS 2010 Rule Update
  • MPFS 2010 Rule Update
  • OIG releases CY 2010 Work Plan – Is your brand at risk?
  • Medicare Administrative Contractor Protest Update
  • Health Economics and Reimbursement
  • The Impact of ICD-10 on MS-DRGs

OIG releases CY 2010 Work Plan – Is your brand at risk?

The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) is the agency charged with protecting the integrity of HHS programs such as Medicare and Medicaid.  The OIG not only investigates provider fraud and abuse but program and management problems as well.  Recently the OIG released its Work Plan for CY 2010.  The document contains a list of issues the OIG plans to investigate in the upcoming year for each of the major entities of HHS including the Centers for Medicare and Medicaid Services (CMS) and the Food and Drug Administration (FDA).  When discrepancies are found the OIG recommends corrective actions for the Secretary of HHS and Congress to implement.

According to the Work Plan the OIG plans to target specific issues that could be of significant concern to drug and device manufacturers.  Some of these issues include:

• Comparing Average Sales Prices (ASP) to Widely Available Market Prices (WAMP)
• Comparing ASP to Average Manufacturer Prices (AMP)
• Medicare Drug Payments Under the Hospital Outpatient Prospective Payment System (OPPS)
• Payments for Off-Label Anticancer Pharmaceuticals and Biologicals
• Part D Pharmaceutical Manufacturer Rebates
• Alternative Calculation of Part D Rebates
• Calculation of AMP
• Additional Rebates of Brand-Name Drugs
• States’ Use of the Average Manufacturer Price To Establish Medicaid Pharmacy Reimbursements
• Foreign Clinical Trials
• Medicare Payments for Part B Imaging Services
• Laboratory Test Unbundling by Clinical Laboratories

The recommendations made by the OIG may have profound implications for your brand product(s) commercialization strategy.  For example, if the OIG finds that that your product’s ASP exceeds its WAMP by 5 percent the OIG may recommend to the Secretary of HHS to change reimbursement for your product from 106 percent of ASP to WAMP.  Also, if the OIG determines that there is an issue with submitting data from foreign trials there could be delays to product launches due to the need to redesign studies.

Clearly with both healthcare reform and the OIG gearing up for CY 2010 this is sure to be an exciting year in the area of healthcare reimbursement.  To better understand how these or other issues impact reimbursement for your product(s) contact us today.