US Sunshine Act

CBI Aggregate Spend West Conference Highlights: Painful Adjustments to New Regulatory Realities

CBI’s 5th Annual Sunshine and Aggregate Spend West conference held in San Diego shed light on the many pain points life sciences organizations have faced, and continue to face in modifying corporate processes and procedures to accommodate for data collection and reporting activities as required by the Federal Sunshine Act. Ben Carmel, Head of Global Offering Development at Polaris, closed the conference with a panel on international compliance for medical device organizations. He noted that EFPIA adoption has been faster than initially anticipated and member nations are considering whether it should be enacted as code or as law. Additionally, he …

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Connecticut Requires Pharmaceutical and Device Companies to Report Payments and Transfers of Value Made To Nurse Practitioners and other APRNs

For the first time in five years a state has passed legislation aimed at reporting payments from pharmaceutical and device manufacturers to healthcare providers. Starting October 2014, Connecticut will require pharmaceutical and device manufacturers to report payments and transfers of value to advance practice registered nurses (APRNs). This group includes nurse practitioners, clinical nurse specialists, nurse anesthetists, and nurse midwives. APRNs are excluded from the reporting obligations under the Federal Physician Payments Sunshine Act. The disclosure requirement is part of a new law in Connecticut that allows APRNs to practice independent of physicians. Pour lire l’article de Policy & Medicine

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Sunshine Act: Inside Look at the Open Payments Phase 2 Uploads, Assumptions Documents, and the Attestation

The Office of Management and Budget (OMB) posted documents that provide a lot of insight into the next steps of the Open Payments System for implementing the Physician Payments Sunshine Act. The Centers for Medicare and Medicaid (CMS) have not yet released detailed information on the Submission and Attestation process, but the OMB Information Collection Request sheds light on important aspects of Phase 2. Pour lire l’article de Policy And Medicine

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Big pharma’s relationship with Canadian doctors needs some U.S.-style sunshine

Ours can be an overly polite country. If the recent Senate spending scandal taught us anything, it’s the value of openness in financial relations. Our American neighbors have come to understand this (somewhat), and now believe that such transparency should not be confined to Congressmen or Wall Street. Lost in the rancor surrounding the Affordable Care Act is a piece of legislation that leans on transparency to enlighten and safeguard patients from conflicts of interest. It’s titled the Physician Payment Sunshine Act, and it’s a rather unapologetic take on a relationship Canada has been relatively bashful about. Pour lire l’article …

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Sunshine Abroad: Evaluating Global Regulations & Transparency Trends

On August 21, 2013 and September 10, 2013, Brian P. Sharkey, J.D, Manager of Regulatory and Compliance Services at PORZIO, discussed international legislation and codes and the global transparency trends affecting the life sciences industry outside of the United States. Among other topics, he reviewed the following: France’s Sunshine Act and implementing decree EFPIA’s disclosure codes United Kingdom transparency requirements Netherlands’ experience with financial transparency Japan’s financial transparency system Industry code revisions and legislative developments in Australia

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4th Global Transparency Reporting Congress | APRIL 8-9, 2014 – LONDON, UK

THE Event to Attend for Global Updates on Transparency Initiatives Guidelines regulating the disclosure of HCP spend are rapidly developing across the globe, including association codes that span across borders. Although laws are not in place in each country, the global nature of the bio/pharmaceutical and medical device industries mandates that companies meet these transparency requirements with total preparedness. Companies must understand the guidelines, ensure effective reporting, and improve organizational transparency processes. This congress focuses on industry best practices for tracking HCP data, creating a context for the information with effective communications, controlling spend on HCPs internally and through third …

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