An organization representing biopharmaceutical research and discovery companies nationwide is asking CMS to explain why it allegedly removed one-third of the data it collected from its Open Payments website. Pharmaceutical Research and Manufacturers of America (PhRMA) Assistant General Counsel John Murphy notes that data was removed, despite the fact that PhRMA member companies seemed to comply with CMS guidelines in submitting information. Murphy asked CMS to offer more transparency about its decision to remove the data and to clarify the reporting regulations.
Section 6002 of the Patient Protection and Affordable Care Act (ACA) (P.L. 111-148) established a program requiring group purchasing organizations (GPOs) and manufacturers of covered drugs, devices, biologicals, or medical supplies to provide HHS with information regarding their financial transactions with physicians or teaching hospitals. The program, known as “Open Payments” or the “Physician Payment Sunshine Act,” is scheduled to report such financial information on a website beginning September 30, 2014, to allow for public transparency. After manufacturers and GPOs reported information, physicians and teaching hospitals were given until August 27, 2014 to review the accuracy of the information submitted about transactions in which they were involved.
Unfortunately, the system was shut down for two weeks while CMS addressed technical issues brought to light by a physician who claimed that payments made to a doctor with the same name were attributed to him. CMS resolved the issues and reopened the system on August 15, 2014, extending the deadline for doctors and hospitals to review information until September 8, 2014 (see Reopening the Open Payments system, CMS extends physician review, (Aug. 20, 2014)). The information is still scheduled to be available to the public on September 30, 2014.
Removal of Data
Policy and Medicine, a website that explores health care compliance issues of interest to life science manufacturers, suggests that the deletion of data may be related to the National Plan and Provider Enumeration System (NPPES) and the Provider Enrollment, Chain and Ownership System (PECOS) databases. For example, errors may occur when a physician’s information, including his or her National Provider Identifier (NPI) does not exactly match against the NPPES or the physician’s NPI is not included in the record.
In the meantime, PhRMA, which supports the Sunshine Act, is seeking to ensure that its members’ diligence in complying with requirements is not disregarded in the future. According to Murphy, “Our industry is committed to working with CMS and the physician community to ensure that all data is accurate, and that proper context is provided to explain how collaborations between companies and physicians can improve patient care and help promote medical innovation.”