HHS Releases Report Comparing Average Sales Price to Average Manufacturer Prices of Prescription Drugs

The Department of Health & Human Services (HHS) Office of Inspector General (OIG) released its latest “Comparison of Third-Quarter 2008 Average Sales Prices and Average Manufacturer Prices: Impact on Medicare Reimbursement for First Quarter 2009″ (the “Report”) on April 17, 2009.  The findings are used to help determined Medicare Part B reimbursement rates for prescription drugs.   You can review the entire Report at http://www.oig.hhs.gov/oei/reports/oei-03-09-00150.pdf.

Mandated by Congress under Section 1847A(d)(2)(B) of the Social Security Act (the Act), the Report reviews the average sales prices (ASP) and average manufacturer prices (AMP) for Medicare Part B prescription drugs to identify the ASPs that exceed AMPs by at least 5 percent. The review also determines the impact of lowering reimbursement amounts for drugs that meet the 5-percent threshold. Pursuant to sections 1847A(d)(3)(A) and (B) of the Act, if OIG finds that the ASP for a drug exceeds the AMP by a certain percentage (currently 5 percent), HHS may disregard the ASP for the drug when setting reimbursement amounts. According to the Report, of the 325 drugs with complete AMP data, OIG found 15 met the 5-percent threshold under the revised ASP payment methodology recently mandated. Twelve of these 15 drugs were previously eligible for price adjustment under the revised methodology, with 2 drugs meeting the 5-percent threshold in each of the past 7 quarters. OIG estimates that, if reimbursement amounts for all 15 drugs had been based on 103 percent of the AMPs, Medicare expenditures would have been reduced by almost three-quarters of a million dollars in the first quarter of 2009. The Report also states that of the 129 drugs with only partial AMP data in the third quarter of 008, 21 had ASPs that exceeded the AMPs by at least 5 percent in the third quarter of 2008.

Under the revised methodology, 12 of the 21 drugs would have met the 5 percent threshold in at least 2 of the past 7 quarters, dating back to the first quarter of 2007. OIG estimates that Medicare expenditures would have been reduced by $9 million during the first quarter of 2009 if reimbursement amounts for all 21 drugs had been based on 103 percent of the AMPs.

If you have questions about the Report, Medicare reimbursement or compliance or any other health care compliance and risk management policies, practices or programs, assessing the strength of your controls in addressing these laws or other healthcare laws and regulations, or in addressing other compliance or health care concerns, please contact Cynthia Marcotte Stamer at cstamer@CTTLegal.com or (214) 270- 2402. For More Information We hope that this information is useful to you. If you need assistance responding to concerns about the matters discussed in this publication or other health care concerns, wish to obtain information about arranging for training or presentations by Ms. Stamer, wish to suggest a topic for a future program or update, or wish to request other information or materials, please contact Ms. Stamer via telephone at (214) 270-2402 or via e-mail to cstamer@CTTLegal.com. You can review other recent updates and other publications by Ms. Stamer and other helpful health care resources and additional information about Ms. Stamer and her experience, see Stamer Health Industry Experience. If you or someone else you know would like to receive future updates about developments on these and other concerns, please be sure that we have your current contact information – including your preferred e-mail- by creating or updating your profile at here or by registering to participate in the Solutions Law Press Health Care Update blog at slphealthcareupdate.wordpress.com. For important information concerning this communication click here. If you do not wish to receive these updates in the future, send an e-mail with the word “Remove” in the Subject to support@SolutionsLawyer.net.

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