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US Sunshine Act

This week is Sunshine Week 2016

This week is Sunshine Week 2016, a national initiative to promote a dialogue about the importance of open government and freedom of information. Additionally, this year also marks the 50th anniversary of the Freedom of Information Act (FOIA). On September 13, 1976, President Ford signed S.5, the Government in the Sunshine Act. This act required multiheaded agencies, including independent regulatory agencies, to hold meetings open to the public unless any of 10 specific reasons for holding closed meetings is present. It also amended FOIA to narrow agencies’ authority to withhold information from the public. “In a democracy the public has …

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Technologies for Gathering and Processing Transfers of Value when Reporting on Events

Compliance

To satisfy Open Payment mandates a great deal of information must be collected, verified, validated and organized. At events, meeting managers must record every transaction in a way that facilitates assignment to multiple participants. Attendance details must be thoroughly recorded for the main event as well as any sub-event. Attendee identities should be validated and include NPI numbers (and, depending on other technology, state license information). Ultimately, attendance and spending information must be properly stored and organized to satisfy various (and frequently changing) compliance regulations while making it available for an audit at any time. This article by Ross Dworkin …

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Open Payments and Continuing Medical Education

A subset of drug, biological, and device manufacturers have raised questions concerning the Physician Payments Sunshine Act (dubbed the Open Payments Program) reporting requirements and participation in commercially-supported accredited and certified continuing medical education (accredited/certified CME) programs in 2016. The following outlines the relevant statutory, regulatory and sub-regulatory guidance issued by the Centers for Medicare and Medicaid Services (CMS) through February 1, 2016. Under the American Medical Association (AMA) CME Credit system standards and Code of Ethics and ACCME accreditation standards, commercial supporters are prohibited from having any direct or indirect influence or control with respect to the content, faculty, …

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Sunshine Act Open Payments Final 2015 Data Submission and Attestation Help

Transparence santé, Sunshine Act

Thomas Sullivan. February 04, 2016 In our latest endeavor to try to help you wade through the lengthy regulations known as Open Payments leading up to the March 31 submission deadline, we drafted the following article on the Final Submission and Attestation process. In order to meet the requirements of Open Payments, officials from manufacturers and GPOs are required to submit final payment or other transfer of data value or ownership/investment interest data. In addition to the actual submission of the data, authorized officials must attest to the accuracy of the data. Once the final data is submitted, the Open …

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Veterinarians face conflicting loyalties to animals, farmers – and drug firms

In 2016, a new U.S. Food and Drug Administration policy will give veterinarians a key role in combating a surge in antibiotic-resistant “superbugs” that infect humans. For the first time, the agency will require veterinarians, not farmers, to decide whenever antibiotics used by people are given to animals. Medical doctors issue antibiotics by prescription only. Yet farmers and food companies have been able to buy the same or similar drugs over the counter to add to feed and water. The drugs not only help prevent disease but enable livestock to grow faster on less feed. The new directive is meant …

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AVMA Board of Directors calls for more discussion on the Veterinarian Payments Sunshine Act

After careful review and examination by several volunteer committees, the American Veterinary Medical Association (AVMA) Board of Directors at its Jan. 8 meeting decided to take a position of “no action” on the Veterinarian Payments Sunshine Act, which has not yet been introduced in Congress. The Board believes that any new regulations imposed on the veterinary profession to disclose conflicts of interest should be rooted in a better understanding of if and where there are issues and has called for further examination of this topic by its expert leaders. For those unfamiliar with the the act, it mimics the Physician …

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