Sunshine Act dispute proposal threatens physicians' due process June 18, 2014 General CMS, Physician Payment Sunshine Act, Centers for Medicare and Medicaid Services 0 A newly proposed dispute resolution process for inaccurate Physician Payments Sunshine Act data would deny physicians their due process rights, the American Medical Association (AMA) and California Medical Association (CMA) told the Centers for Medicare and Medicaid Services (CMS) in comment letters this week. Under the Sunshine Act, drug and medical device manufacturers are required to report their financial interactions with licensed physicians – including consulting fees, travel reimbursements, research grants and other gifts. Any payments, ownership interests and other “transfers of value” will be reported to CMS for publication in an online database to be launched this fall. According to CMS, sometime in July physicians will be able to begin reviewing the data reported by drug and device manufacturers. Physicians will then have 45 days to review and dispute any inaccuracies and 15 days to resolve disputes. CMA and AMA have a number of concerns with the proposed dispute resolution process. Among them is the fact that manufacturers and group purchasing organizations (GPOs) are authorized to unilaterally dismiss disputes lodged by physicians without resolution of the dispute. Such unilateral dismissal is in direct violation of the final Sunshine Act rule. "The final rule does not authorize manufacturers or GPOs to dismiss disputes without both parties agreeing that the dispute is resolved," CMA President Richard Thorp, M.D., wrote in CMA's comments. According to the rule, if the parties are unable to resolve the dispute, the reported data is to be marked as disputed and flagged as such in the public database until resolution has been reached between the parties. However, allowing manufacturers/GPOs to unilaterally dismiss disputes without physicians’ agreement or consent would result in disputed data being posted publicly without any flag to indicate that it has been disputed, violating physicians' due process rights. CMA and AMA are worried this dispute resolution process could cause physicians economic and reputational harm, especially since the point of the Sunshine Act program is to give the public an accurate picture of the financial interactions between physicians and the drug industry. For more information, see CMA's letter to CMS on this issue. Physicians are also reminded that they can now begin the registration process, which is necessary in order for physicians to be able to access, review and potentially dispute data reported by drug and device manufacturers under the Sunshine Act. The two-step registration process first requires physicians to register at the CMS Enterprise Portal, a step many physicians may have already completed as the gateway enables access to a number of other CMS programs. Step two will be registration in CMS’ Open Payments system, which is set to begin in early July. More information on how to register will be available on the CMS website. Additional details are available in AMA's online “Physician Sunshine Act Tool Kit,” which provides a variety of resources to help physicians navigate the Sunshine Act changes, including a free webinar, a list of important dates, answers to frequently asked questions, information about how to challenge incorrect reports and suggestions for creating more transparency with patients about the physician's interactions with the pharmaceutical and medical device industries. Comments are closed.
