Section 6002 of the Affordable Care Act (ACA) requires manufacturers of pharmaceuticals, biologicals, medical devices or supplies to publicly report payments made to physicians and teaching hospitals. This article evaluates the impact of this new requirement on physicians.
The Centers for Medicare & Medicaid (CMS) has recently issued the final Physician Payment Sunshine Rule, also know as Open Payments or the National Physician Payment Transparency Program (“Program”) which clarifies the requirements of Section 6002 of the ACA. The Program requires reporting of (1) any payments or “transfers of value” provided by manufacturers of drugs, biologicals, medical devices or supplies (“applicable manufacturers”) covered under Medicare, Medicaid or the Children’s Health Insurance Program to physicians and teaching hospitals; and (2) ownership or investment interests that are held in either applicable group purchasing organizations or applicable manufacturers by physicians or their immediate family members.
In order to trigger the Program reporting requirements the payment or transfer of value has to exceed the minimum threshold. The statute defines that threshold as any payment or transfer of value greater than $10. If, however, individual payments in aggregate exceed $100 during a calendar year then all payments must be reported. Going forward these dollar amounts will be increased by the same percentage as the percentage increase in the consumer price index.
The Program impacts all physicians, irrespective of their enrollment status with Medicare, Medicaid, or CHIP. The law defines “doctor” to include MDs, DOs, ODs, DDS, DMPs, and DCMs. Reporting of payments or transfers of value to residents, however, is not required.
As of August 1, 2013, applicable manufacturers and applicable group purchasing organizations began collecting the data and will do so through the end of the year for their 2014 reporting requirements. The 2013 information has to be provided to CMS by March 31, 2014. While the reporting for 2013 will be for the partial year, reporting for 2014 will be for the entire year and record collection begins on January 1.
CMS will aggregate that data by specific physician and teaching hospital and make it publicly available. Starting in 2014 and in subsequent years, data collection occurs between January 1 and December 31. Applicable manufacturers and group purchasing organizations are required to submit annual reports to CMS electronically on or before March 31 for data collected during the preceding year. CMS advises that after 2014, the agency will have to make the data available on the public site by June 30 each year rather than September 30.
Data To be Reported
Some of the specific items that applicable manufactures and group purchasing organizations are now required to tally and report include, but are not limited to: 1) speaking and consulting fees; 2) honoraria; 3) gifts, entertainment, food and beverages; 4) travel and lodging; 5) education; and 6) research.
Patient drug samples and transfers of value to physician staff or non-physician prescribers such as nurse practitioners are not reportable. CMS warns, however, that to the extent that applicable manufacturers make payments or other transfers of value to non-physician prescribers to be passed through to a physician, they would be indirect payments to the physician and would have to be reported under the name of the physician.
Disputing Reported Data
Prior to the information becoming publicly available, physicians will be given 45 days to analyze and dispute, where applicable, the collected information. After the end of the 45-day period, there will be an additional 15-day period to further resolve the disputes. Disputed data which are not resolved by the end of the 15-day period will be published on the public website but will be marked as disputed.