Establish a set of procedures through which ASP, AMP, Best Price, and non-FAMP submissions are automatically subjected to
regular historical review. Significant deviations from historical norms should trigger close inspection of pricing figures
before they are submitted to CMS or the VA.
Establish a data storage facility where pricing data can be kept for at least 10 years. By rule, manufacturers are required
to maintain records on their participation in the Medicaid and Medicare programs for at least 10 years, and longer if the
company is subject to an audit or investigation.
Government price reporting requirements can be daunting and demanding, particularly for executives, lawyers, and business
managers who do not have time to master and stay abreast of the detailed legal and regulatory requirements. But companies
that use such complexity as an excuse for not ensuring the accuracy and integrity of the data they report to the government
are taking significant risks in today's regulatory environment. The consequences of performing the calculations improperly
can be truly disastrous to a pharmaceutical manufacturer that hopes to continue selling its products in the United States.
Most companies that have taken the time to review and update their pricing policies and procedures have found it to be a very
Anthony Farino (email@example.com
) is a US pharmaceutical advisory services leader and Timothy Nugent (firstname.lastname@example.org
) is a director with PricewaterhouseCoopers. John T. Bentivoglio
), partner, and John Shakow email@example.com
, counsel, are with law firm King & Spalding.