US Sunshine Act

Physicians Express Concern Over Sunshine Act Rollout

Doctors and pharmaceutical and device companies have worked hand-in-hand to advance medicine throughout history. Without such teamwork, essential innovations may have lived in obscurity or not have been developed at all. Yet, research and experience have also revealed that such financial ties can lead to bias in a doctor’s decision making, for instance influencing the drug he or she prescribes or the device used. In some cases, this influence may be detrimental to patients, scientific research or our health care system. The ubiquity of these physician–industry relationships, along with concerns about conflicts of interest, has spurred a national effort by …

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Pharmaphobia: The Conflict-of-Interest Myth

On April 29, the House Energy and Commerce Committee released a new discussion draft of the 21st Century Cures Initiative, a bill intended to revitalize and streamline American medical innovation. If we, as a nation, want to continue to lead the world in medical innovation, we cannot allow myths to unjustly color our impression of the biopharmaceutical and medical-device industries and those physicians and researchers who work with them. Several studies recently published in Health Affairs suggest that current profits may be insufficient to sustain our present level of medical innovation. We should avoid passing legislation that makes medical innovation less …

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A Dark Cloud Still Lingers Over Sunshine Act

By Evan Levine, M.D. George Orwell, the inventor of the Ministry of Truth, could not have coined a more biting and sarcastic title than the Sunshine Act. With the advance of the Affordable Care Act the Physician Payments Sunshine Act (now known as Open Payments) could certainly create a dark cloud over every physician who accepted any funding, even a cup of coffee, from Big Pharma or medical device companies; the sun would no longer shine over doctors who made thousands of dollars by giving talks for $2,000 a night in some expensive local restaurant, in front of physicians who …

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Physician Payment Sunshine Act: CMS Submits Report to Congress on First Year of Open Payments

April 27, 2015 – Thomas Sullivan Over the weekend, the Centers for Medicare and Medicaid Services (CMS) submitted their annual report to Congress on the first year of Open Payments. Each year, CMS is required to submit a report to Congress summarizing the payments made by applicable manufacturers and group purchasing organizations to physicians and teaching hospitals, as well as any penalties CMS assessed based on noncompliance with the program. The document is an interesting “inside-look” into CMS’s activity, and offers the industry an idea of where the agency is headed with Open Payments, including program implementation improvements, and, perhaps …

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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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