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Medicare Compliance & Reimbursement

PHARMACEUTICALS:

Date Set For Drugmakers To Hand Over Pricing Data

Published on Thu Apr 15, 2004

Government ready to ratchet up its scrutiny of Big Pharma.

It's official: A new price reporting era has arrived for drug manufacturers.
 
An interim final rule in the April 6 Federal Register requires all average sales prices for Medicare Part B covered drugs and biologicals to be reported each quarter to the Centers for Medicare & Medicaid Services - starting April 30.
 
Set up by provisions in the reform bill, the ASP reporting requirements include certain oral anti-cancer and immunosuppressive drugs, drugs provided through the durable medical equipment benefit and drugs provided incident to a physician's service.
 
Here's what you need to be sure and include when calculating your ASP:

 

  • volume, prompt pay and cash discounts,
     
  • free goods that are contingent on any purchase requirement,
     
  • chargebacks, and
     
  • rebates other than those under the Medicaid drug rebate program.

    According to the rule, CMS will be backing up its new reporting requirement with a little muscle. Inaccurate reports will be subject to penalties of up to $10,000 for each price misrepresentation and for each day in which the price misrepresentation was applied.
     
    To see the rule, go to:     http://www.access.gpo.gov/su_docs/fedreg/a040406c.html.
     
    Lesson Learned: Drugmakers are under the gun to make sure all average sales price information squares with CMS requirements.

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