The potential for inaccurate or misleading information is one reason why it is so important that you follow policies and procedures related to accepting gifts or payments. increased administrative and compliance burden.distorted public perception of legitimate transactions, and. unwarranted suspicion of legitimate and vital physician-industry collaborations,.Potential problems include the following issues: What are some of the potential problems with this reporting? the nature of the payment (research, education, travel, etc.), and.the city and state of the PI and the entity,.the name of the principal investigator (PI),.The information displayed on these websites will include One site, run by the news organization ProPublica, is called Dollars for Docs. Some information is already available on sites run by companies and special interest groups. Starting in September 2014, payment information will appear on the CMS public website. Two exceptions are product samples that are for patient use only and not intended for sale and educational materials that directly benefit patients. There are, however, exceptions where a direct payment or transfer of value is not subject to reporting. This includes, for example, consultation fees, funding for clinical research, travel reimbursement, education, and royalties or licenses. Manufacturers of drug, device, biological, or medical supplies participating in federal health care programs will have to report any direct payments or transfers of value to you as the physician and/or to SCPMG if they are valued at $10 or more. Headlines such as this one prompted action from lawmakers, ultimately leading to the Sunshine Act. Stories about doctors who prescribed controversial and expensive brand-name drugs over less costly or generic options led to headlines like Big pharma and greedy doctors are a prescription for fraud and abuse. The law came in response to a series of scandals in which health care professionals seemed to be influenced by gifts or payments from pharmaceuticals and other industry players. This is one of the most common questions asked. This term encompasses basic and applied research and product development. Research: A systematic investigation designed to develop or contribute to generalizable knowledge relating broadly to public health, including behavioral and social-sciences research.Clinical Investigation: Any experiment involving one or more human subjects, or materials derived from human subjects, in which a drug, device, biological, or medical supply is administered, dispensed, or used.The CMS requires manufacturers to report payments for research separately from other payments and transfers of value and to disclose additional data elements, including the study name and principal investigator’s name. What does the Sunshine Act mean for research? Institutions and other recipients of payments will have 45 days to review the data and submit feedback before it goes live on the CMS public website. The information will be posted to the CMS website and available to the public starting on September 30, 2014. They have to report data gathered through December 2013 to the Centers for Medicare & Medicaid Services (CMS) by March 31, 2014. Pharmaceutical and medical device companies were required to start compiling information in August 2013. The Sunshine Act, part of the Affordable Care Act, requires drug and device manufacturers that receive government reimbursements to collect data on gifts and payments to teaching hospitals and physicians. To help guide you through the key points, we’ve compiled the answers to frequently asked questions below. If you are involved in research that receives funding from industry sponsors, it is very important that you understand what the Sunshine Act means to you. The law requires drug and device makers to collect and disclose information about payments to teaching hospitals and physicians. Over the past few months, we have been traveling throughout the region to talk to physicians and others about the Sunshine Act, formally known as the National Physician Payment Transparency Program.
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