Basic Sunshine Law Reporting Requirements
Section 6002 of the Patient Protection and Affordable Care Act (the “Sunshine Law” or “Open Payments Law”) requires certain manufacturers of medical devices, drugs and biologicals ("Applicable Manufacturers") and certain group purchasing organizations ("GPOs") to report to CMS information related to their relationships with physicians and teaching hospitals.
Specifically, an Applicable Manufacturer is required to report:
- any payment or other transfer of value made to a physician or teaching hospital ("Covered Recipient") by the Applicable Manufacturer; and
- any ownership or investment interest held by a physician or the physician’s immediate family member in the Applicable Manufacturer.
A GPO is required to report:
- any ownership or investment interest held by a physician or the physician’s immediate family member in the GPO; and
- any payment or transfer of value made to any physician owner or investor if the physician held the interest during the reporting year.
Applicable Manufacturers and GPOs were required to report the required data about Covered Recipients by June 30, 2014 for the period August 1, 2013 through December 31, 2013. For purposes of the Sunshine Law, the term “physician” includes physicians, dentists, podiatrists, optometrists and chiropractors.
Providers Must Register in Order to Review Data
Covered Recipients have the right to review and dispute any information reported about them. CMS established a registration process to enable Covered Recipients to access the data reported about them and dispute any information they believe is incorrect. Although registration is voluntary, a Covered Recipient will be able to review and dispute the submitted information only if they are registered.
For the first year of implementation, CMS established a two-phase Covered Recipient registration process. The first phase started June 1, 2014 and permitted Covered Recipients to register through the Enterprise Identify Management System (EIDM) and use the resulting EIDM registration credentials to access the Open Payments/Sunshine system. (Some providers may already have registered through EIDM for purposes of online access to other government programs.)
The second phase began on July 14, 2014 and permits Covered Recipients to register and request direct access to the Open Payments system. Once registered, the Covered Recipient can access all information reported to CMS about them. Before granting access to the system, CMS will verify the provider’s identity. Because the identity verification can take some time, CMS is encouraging Covered Recipients to register as soon as possible to allow sufficient time to review all information submitted about them by Applicable Manufacturers and GPOs and file any disputes by the deadline described below.
A Covered Recipient has until August 27, 2014 to review and dispute the accuracy of information submitted to CMS by an Applicable Manufacturer or GPO. Such disputes must be filed with the Applicable Manufacturer or GPO; CMS is not involved in the dispute resolution process. Applicable Manufacturers and GPOs must attempt to resolve timely-filed disputes between August 28 and September 11, 2014. If the dispute is not resolved by September 11, 2014, the data will be posted to the CMS website on September 30, 2014 with a notation that the data is under dispute. If the dispute is subsequently resolved, the Applicable Manufacturer or GPO will submit any corrected data to CMS and CMS will correct the posted information the next time the website is updated.
Physicians and teaching hospitals that are not already registered should register immediately and review any information posted about their relationships with Applicable Manufacturers or GPOs. If the physician or teaching hospital does not agree with the information posted, they should immediately initiate the dispute process. Applicable Manufacturers and GPOs are likely to be faced with several disputes and the time available for reporting and resolving disputes is extremely short. There will be no opportunity for a physician or teaching hospital to review the information or initiate the dispute after August 27, 2014.