Medicare Compliance & Reimbursement

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.