Price reporting compliance and analysis
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. The importance of achieving compliance with these regulations is underscored by the significant increase in enforcement actions and corresponding fines, damages, penalties, and potential exclusion from governmental programs. 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 governmental investigations and litigation related to their historical price reporting, and we have assisted them in achieving forward-looking compliance with existing price reporting regulations.
In a compliance setting, our professionals assist clients by collaborating with compliance attorneys both to identify the range of acceptable solutions and to provide strategic advice regarding the impact each solution would have on the client’s business objectives. Our industry experts, economists, and software engineers develop customized, automated processes for calculating prices and generating standard price reports. In investigatory and litigation environments, our professionals support clients facing False Claims Act and other fraud allegations connected to price reporting. We provide strategic guidance early in the process by identifying the scope of the alleged misreporting and quantifying potential exposure. Subsequently, we provide settlement support, litigation consulting support, or expert testimony focusing on economic analyses of liability, causation, and damages.
- 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. Identified and filled gaps in existing data, constructed price calculation algorithms that achieved compliance while optimizing business outcomes, and developed software that enables the client to generate monthly price reports with push-button operation. Also reviewed and recommended refinements to the client’s existing process for calculating federal AMP.
- 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. Provided consulting expertise on liability, causation, and damages, and participated in settlement discussions with the government.
- 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 report, deposition, and hearing testimony on behalf of Amgen, which was granted a permanent injunction barring F. Hoffman La-Roche from entering the US market with its competing drug.
- 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.