In the fall of 2014, the Centers for Medicare and Medicaid Services (CMS) launched its Open Payments website, a public, searchable database for information regarding payments made to physicians and teaching hospitals by pharmaceutical companies, medical device manufacturers, and other “applicable manufacturers” in the life sciences.
Currently, the searchable database contains information on payments made between August 1, 2013, through December 31, 2013, including the number of discrete payments made to each physician or teaching hospital, the form of each such payment (e.g., cash, in-kind items, stock), and the consideration for the payment (e.g., consulting fee, food and beverage, travel, education).
The scope of the data release included approximately $3.5 billion in payments received by 546,000 physicians and 1,360 teaching hospitals from 1,419 applicable manufacturers. Of these totals, about $2.2 billion (approximately 63% of total payments, or approximately 39% of total payment records) was de-identified before publication. While the database does not currently note the respective recipient, CMS has stated this data will be identified during a future cycle.
The regulations governing the Open Payments program afford physicians and teaching hospitals the opportunity to review and dispute payment information prior to public release. During the period leading up to the public release of data, multiple shutdowns of the Open Payments website in which physicians and teaching hospitals could view and verify their reported payment data caused widespread concern regarding the accuracy of the information. The data integrity issues that caused CMS to temporarily close the system stemmed from the attribution of payments to misidentified physicians.
Specifically, an error was reported in which one physician’s payments were incorrectly attributed to another physician, which alerted CMS to the “intermingling” of data for physicians with the same first and last names. Upon discovery of the problem, CMS elected to delay the release of a portion of data for 2013 until a later date. The scope of this dataset, which was reported to CMS but not published (de-identified or otherwise) totals approximately $1.1 billion, or 199,000 records.
Despite concern regarding the accuracy of Open Payments data, only 26,000 physicians and 405 teaching hospitals successfully registered in the system during the initial review period. Of the 4.4 million records submitted, 17,994 records were affirmed, while 12,579 records were disputed (with 9,000 of these disputes still unresolved).
Applicable manufacturers now have through March 31, 2015, to report 2014 payments (i.e., payments made between January 1 and December 31, 2014), as well as corrected 2013 reports. These reports will be available to the public in June of this year. Prior to that date, physicians and teaching hospitals will again have the opportunity to review and dispute the submitted payment information.
In light of nagging concerns regarding the accuracy of Open Payments reporting, and given the potential ramifications of public reporting, it is imperative that all impacted parties—physicians, teaching hospitals, and applicable manufacturers—plan their review, implementation, and compliance efforts accordingly. For more information, PYA’s upcoming white paper, “Don’t Get Burned By The Sunshine Act: Scrutinizing Physician Compensation,” will discuss the fair market value and commercial reasonableness issues that may arise when life sciences organizations make payments to physicians, and how these organizations can mitigate their associated regulatory risks. PYA has extensive experience in navigating the complex healthcare regulatory environment, and is well-positioned to assist all parties as they address the compliance issues that may arise due to the public release of Open Payments data.
