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US Sunshine Act

Bipartisan Bill Seeks Fix to Formalize Textbook/Reprint Sunshine Act Exclusions

After multiple efforts failed to convince the Centers for Medicare & Medicaid Services (CMS) that peer-reviewed journals, journal supplements, journal reprints and medical textbooks are educational materials that benefit patients and patient care, Rep. Michael Burgess (R-TX) and Rep. Allyson Schwartz (D-PA) introduced bipartisan legislation last month that is intended to counter the unintended consequences of the current Physician Payments Sunshine Act regulations, which state that when industry provides these materials to healthcare providers they are considered reportable transfers of value. To read the article by the Coalition for Healthcare Communication

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Proposed Changes to the Sunshine Act Will Be Expensive for Medtech Companies

In July 2014, the Centers for Medicare and Medicaid Services (“CMS”) issued proposed revisions to the rules governing the reporting requirements under the federal Physician Payments Sunshine Act (which CMS refers to as the Open Payments requirements). Two of the proposed changes – if adopted – could have a significant impact on medical device manufacturers’ obligations to track and report to CMS payments and transfers of value they provide to U.S. physicians and teaching hospitals. Moreover, if adopted, the time permitted to incorporate the changes into systems, processes, and operations could be short (possibly little more than 30 days). Device …

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Men Dominate List of Doctors Receiving Largest Payments From Drug Companies

Few women are on the list of doctors paid the most money by drug and medical device companies last year, according to a ProPublica analysis of new data released by the federal government. More than 90 percent of the 300 doctors who collected the most money for speaking and consulting are men, based on information from the new government database, called Open Payments. By comparison, men accounted for about 68 percent of active physicians in the United States in 2012, according to the Association of American Medical Colleges. To read the article by Charles Ornstein

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Cost of Sunshine Act : $160 million by year for applicable manufacturers and GPOs

In total, CMS estimated in 2011 that for applicable manufacturers and applicable GPOs required to report, it will cost $193,037,104 for year 1 and will cost $144,777,828 for year 2 and annually thereafter. For the first 3 years, this averages to a cost of $160,864,253 annually. In addition to FTE costs, CMS also assumed that there would be some infrastructure costs associated with the reporting requirements. CMS also acknowledged a “substantial amount of uncertainty in these estimates.” For example, CMS does not know how many companies will be using existing systems and technology to comply with the requirements and how …

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Sunshine Act | CMS Open Payments Data Fact Sheet

Industry organizations, such as PhRMA, AdvaMed and BIO, continued to voice concerns when the data was released regarding the lack of context provided to the public regarding Open Payments. BIO’s press release stated: “CMS failed to provide the necessary context about these disclosures – and how they should be read. We are very concerned that some third parties will attempt to misuse the data, potentially threatening innovation in our nation’s health care system.” In response to this criticism, CMS released today a Fact Sheet that provides additional, high-level information regarding data released in the Open Payments database last week.

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If the new Open Payments website were a consumer product, it would be returned for a full refund.

If the federal government’s new Open Payments website were a consumer product, it would be returned to the manufacturer for a full refund. Open Payments is the government’s site for publishing payments made to doctors and teaching hospitals by drug and medical device manufacturers. It includes 4.4 million payments, worth $3.5 billion, to more than half a million doctors and almost 1,360 teaching hospitals. In a news release announcing the site’s launch, the Centers for Medicare and Medicaid Services said the goal was “to help consumers understand the financial relationships between the health care industry, and physicians and teaching hospitals.” …

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