US Sunshine Act

US Sunshine Act | Open payments user guide

This Open Payments User Guide includes definitions, descriptions, screenshots, tools, and tips designed to help applicable manufacturers, applicable group purchasing organizations (GPOs), physicians, and teaching hospitals better understand how to comply with Open Payments (the Sunshine Act), including how to operationalize the collecting and reporting of data. As the Open Payments system develops, the User Guide will be updated accordingly. The User Guide consists of the following chapters: • Introduction to Open Payments • Introduction to Reporting and Data Collection • Applicable Manufacturer and Applicable Group Purchasing Organization (GPO) Registration • Data Submission and Attestation • Audits • Non-Compliance and …

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Open Payments Dispute Resolution Call Reveals Tension Between Manufacturers and Covered Recipients

On Wednesday afternoon, the Centers for Medicare and Medicaid Services (CMS) held a teleconference for physicians and teaching hospitals to help them through the process of reviewing their Open Payments data and potentially disputing their information. Notably, CMS has streamlined their teaching tools for physicians to a manageable 38-page PowerPoint. CMS re-iterated their position that they will not be involved in mediating disputes. However, “CMS will monitor disputes and resolutions to inform the program auditing process,” they stated. “How many disputes are initiated as well as the volume of unresolved disputes,” will be of particular interest to the government. To …

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Conflicts of Interest at the F.D.A.

The Food and Drug Administration’s lethargic regulation of dietary supplements containing a dangerous stimulant described in recent reports in The Times is a classic example of what happens when industry representatives infiltrate the agency that is supposed to regulate them. Much of the responsibility for the F.D.A.’s sluggish response must fall on Dr. Daniel Fabricant, who left a senior position at the Natural Products Association, a trade group for supplement makers and sellers, to head the F.D.A.’s division of dietary supplement programs in early 2011 and who jumped back to the trade association as its chief executive in the spring …

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US Sunshine Act | Review financial data before it goes public in June

Starting today, physicians have 45 days to review and dispute reports regarding their financial interactions with manufacturers of drugs and medical devices reported under the Physician Payments Sunshine Act (also known as the Open Payments program). Here’s what you need to know about the process before the Centers for Medicare & Medicaid Services (CMS) makes the data available to the public this summer. To read the article by the American Medical Association

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Market Research and Sunshine Act: Has Physician Participation Declined Due To Open Payments?

The market research space is an interesting one as far as Sunshine reporting is concerned because it implicates many of the same challenging “indirect payment” issues we have seen related to continuing medical education (CME). This article describes a number of those reporting challenges and also looks at a recent survey that sought to measure physicians’ current awareness of Open Payments and to assess the impact the release of the data was having on physician participation in manufacturer sponsored market research. To read the article by Policy and Medicine

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