The federal government has long been concerned about payments to physicians by drug and medical device companies in the form of meals, entertainment, travel, consulting fees, honoraria, research grants, charitable contributions, and investment interests. Rather than prohibit these payments – which more often than not serve legitimate purposes – a federal law known as the Sunshine Act now requires drug and medical device companies to report certain transfers of value to physicians.
Starting September 30, the general public will have access to these reports. A patient, for example, will be able to look up whether his or her physician has received anything of value from the maker of a drug the doctor has prescribed for the patient.
Since August 2013, drug and medical device companies have been required to compile data regarding physician payments. During June, these companies must upload this information to the Open Payments system, the federal database created for this purpose, and attest to the accuracy of the information.
The Sunshine Act affords physicians the opportunity to dispute reports made about them. To do this, however, a physician must complete a two-step registration process. A physician is not required to register, but will need to do so if he or she wants the opportunity to review and dispute reports before they go public.
The first step in the process is to register using the Centers for Medicare & Medicaid Services’ (CMS) Enterprise Portal.
Starting in mid-July (the date has not yet been announced), those who have registered though the CMS Enterprise Portal will be able to register for access to the Open Payments system. This second step in the registration process will remain open for 45 days. If a physician does not register during this 45-day window, he or she will lose the opportunity to dispute any report regarding payments made in 2013. There will be a second registration process for subsequent reporting years.
Once registered, a physician will be able to review any and all reports submitted by drug and medical device companies about payments made to the physician. If the physician believes a report is inaccurate, he or she can dispute the information. Detailed information on the dispute process is available here.
Earlier this month, CMS issued a revised User Guide for the Open Payments system. The guide includes a detailed explanation of all reporting requirements and deadlines for submission.
With public access to these reports only weeks away, physicians not only should be registering to review and dispute reports, but preparing to answer questions and address patient concerns regarding payments received from drug and medical device companies. PYA can assist your practice with the registration process, reviewing and disputing reports, developing responses to patient questions and concerns, and drafting and implementing a vendor relations policy. For more information, please contact Denise Hall at PYA, (800) 270-9629.
