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US Sunshine Act

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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Physician Payments Sunshine Act database: Which specialties receive the highest payments?

The Centers for Medicare and Medicaid Services‘ Open Payments program implements Section 6002 of the Affordable Care Act requiring medical product manufacturers to report payments made to physicians or teaching hospitals as well as ownership or investment interests held by physicians in the manufacturer. To determine the characteristics and distribution of these industry payments by specialty, we analyzed physician payments made between August 1, 2013, and December 31, 2013, that were publicly disclosed by Open Payments. We compared payments between specialty types (medical, surgical, and other) and across specialties within each type using the Pearson χ2 test and the Kruskal-Wallis …

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Banning TV Drug Ads: Could the Cure Cause More Harm Than Good?

Direct-to-consumer (DTC) advertising in the U.S. of prescription drugs and medical devices is in the spotlight, with the American Medical Association (AMA) calling for a ban on it. The Chicago-based physicians group issued a statement last month that it has adopted a policy to block such advertising. The AMA’s chief argument is that the “growing proliferation of ads is driving demand for expensive treatments despite the clinical effectiveness of less costly alternatives.” Patrice A. Harris, chair-elect of the AMA, added: “Direct-to-consumer advertising also inflates demand for new and more expensive drugs, even when these drugs may not be appropriate.” The …

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Senate Finance Committee Hearing on Physician Owned Distributorships (PODs) Highlights the Complexity of the Issue

Transparence santé, Sunshine Act

November 20, 2015 by Thomas Sullivan The Senate Finance Committee has been conducting an investigation into Physician Owned Distributorships (PODs), leading to at least one referral to the Health and Human Services Office of Inspector General for potential action, the case of a device manufacturer who offered to make payments to doctors through a third party to avoid disclosure. To read the article by Policy & Medicine

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