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Price reporting compliance and analysis

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Overview

A complex and evolving array of federal and state regulations require many of Bates White’s clients routinely to report prices such as AMP, Best Price, ASP, AWP, WAC, Texas Medicaid/CHIP Vendor Drug Program prices, and usual and customary prices. With our unparalleled insight into pricing at all points of the supply chain, our deep familiarity with internal business processes and data, and our extensive experience managing large data, we support clients as they respond to government investigations and litigation related to their historical price reporting, and we assist them in achieving forward-looking compliance with contemporaneous price reporting regulations.

Selected Work

  • In response to changes to the regulatory requirements for reporting prices to Texas Medicaid’s Vendor Drug Program, collaborated with in-house and outside legal counsel to support a generic manufacturer in developing functional price reporting procedures
  • Prepared a report for a trade group representing research-based pharmaceutical and biotechnology companies that evaluated potential compliance costs resulting from new Affordable Care Act requirements related to the calculation of AMP.
  • In United States of America, et al., ex rel. Ronald J. Streck v. Allegan, Inc., et al., estimated the potential exposure of a pharmaceutical manufacturer facing allegations that it failed to factor off-invoice price increases into its AMP calculation, resulting in the understatement of AMP and lower rebates paid to the Medicaid Drug Rebate Program.
  • Served as lead consulting expert for a major drug manufacturer throughout a multiyear government investigation spanning several products and allegations, including that certain alleged price concessions were not factored into the calculation of ASP, causing the ASP and corresponding Medicare reimbursements to be overstated. 
  • In The State of Texas ex rel. Ven-A-Care of the Florida Keys, Inc. v. Mylan Inc., served as a testifying expert on behalf of a leading generic pharmaceutical manufacturer defending allegations that it submitted false prices to the Texas Medicaid Vendor Drug Program. Submitted written report and deposition testimony. 
  • In Amgen v. F. Hoffman-La Roche, analyzed the unique implications of the new (at the time) ASP-based Medicare reimbursement methodology on competitive pricing dynamics among drug manufacturers and potential entrants and the impact on providers and payors. 
  • Provided written, deposition, and trial expert testimony on behalf of a number of pharmaceutical manufacturers in expansive federal and state multidistrict Average Wholesale Price Litigation, in which public and private insurers allege that they overpaid for prescription pharmaceuticals as a result of inflated prices published by manufacturers. 
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