US Sunshine Act

Compliance Officers as Chief Data Analyst

Transparence santé, Sunshine Act

March 18, 2016 by Thomas Sullivan. With the US Sunshine reporting data fast approaching March 31, compliance teams are heads down in getting the spend records collected, audited and ready for final reporting. The frenzy of systems issues (both internal and CMS), personnel challenges and vendor management makes the race to the finish line a close call for most compliance team. How does one take a break to analyze the data before it goes in for submission? What are the risks for submitting data in the public domain without a pre-audit and analytical review? After conversations with a variety of …

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Now There’s Proof: Docs Who Get Company Cash Tend to Prescribe More Brand-Name Meds

This story was co-published with NPR, the Boston Globe and the Tampa Bay Times. Doctors have long disputed that the payments they receive from pharmaceutical companies have any relationship to how they prescribe drugs. There’s been little evidence to settle the matter — until now. A ProPublica analysis has found for the first time that doctors who receive payments from the medical industry do indeed tend to prescribe drugs differently than their colleagues who don’t. And the more money they receive, on average, the more brand-name medications they prescribe. We matched records on payments from pharmaceutical and medical device makers …

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Mining Open Payments Spend Data: Managing the Risk of Transparency

At a Food and Drug Law Institute webinar last week, Robin Usi, the Director for the Division of Data & Informatics (DDI), in the Data Sharing & Partnership Group of the CMS Center for Program Integrity, made clear that accuracy matters in the reporting of spend data to CMS pursuant to the Physician Payments Sunshine Act. She further stated that CMS is working to identify inaccurate data reporters and that reporters of inaccurate data are prime targets for agency audit and/or compliance actions. Government enforcers, private plaintiffs and even investigative reporters are mining this data to make the case that …

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This week is Sunshine Week 2016

This week is Sunshine Week 2016, a national initiative to promote a dialogue about the importance of open government and freedom of information. Additionally, this year also marks the 50th anniversary of the Freedom of Information Act (FOIA). On September 13, 1976, President Ford signed S.5, the Government in the Sunshine Act. This act required multiheaded agencies, including independent regulatory agencies, to hold meetings open to the public unless any of 10 specific reasons for holding closed meetings is present. It also amended FOIA to narrow agencies’ authority to withhold information from the public. “In a democracy the public has …

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Technologies for Gathering and Processing Transfers of Value when Reporting on Events


To satisfy Open Payment mandates a great deal of information must be collected, verified, validated and organized. At events, meeting managers must record every transaction in a way that facilitates assignment to multiple participants. Attendance details must be thoroughly recorded for the main event as well as any sub-event. Attendee identities should be validated and include NPI numbers (and, depending on other technology, state license information). Ultimately, attendance and spending information must be properly stored and organized to satisfy various (and frequently changing) compliance regulations while making it available for an audit at any time. This article by Ross Dworkin …

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Open Payments and Continuing Medical Education

A subset of drug, biological, and device manufacturers have raised questions concerning the Physician Payments Sunshine Act (dubbed the Open Payments Program) reporting requirements and participation in commercially-supported accredited and certified continuing medical education (accredited/certified CME) programs in 2016. The following outlines the relevant statutory, regulatory and sub-regulatory guidance issued by the Centers for Medicare and Medicaid Services (CMS) through February 1, 2016. Under the American Medical Association (AMA) CME Credit system standards and Code of Ethics and ACCME accreditation standards, commercial supporters are prohibited from having any direct or indirect influence or control with respect to the content, faculty, …

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