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US Sunshine Act

Is 2016 The Year That CMS Starts Fining Sunshine Act Violators?

The third annual Physician Payments Sunshine Act (“Sunshine Act”) reporting deadline has come and gone. If you are an applicable manufacturer and this law is news to you, you might be getting fined. The most recent reporting deadline was March 31st, 2016. Previous reporting cycles included 2013 (partial report out) and 2014. Failure to report can result in Civil Monetary Penalties (“CMPs”) assessed by the Centers for Medicare and Medicaid Services (“CMS”) and bad publicity. Presumptively, when CMS fines the first manufacturer or group purchasing organizations (“GPOs”) for a reporting failure, it will be publicized in order to compel industry …

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US Sunshine Act : Check your 2015 Open Payments data

CMS, Sunshine Act, Transparency

By Shantanu Agrawal, M.D, Deputy Administrator and Director of CMS’ Center for Program Integrity The Centers for Medicare & Medicaid Services’ continues to publish data from applicable manufacturers and group purchasing organizations (GPOs) about payments they make to physicians and teaching hospitals on its website, https://openpaymentsdata.cms.gov/. We’re pleased that the public has searched Open Payments data more than 6.3 million times. Doctors, teaching hospitals and others receiving payments or other transfers of value that are sent to us from reporting entities, should take steps to ensure that this information about you, your related research, ownership, and other financial concerns are …

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U.S. Seeks Records of 80,000 Novartis `Sham’ Events for Doctors

The U.S. is asking Novartis AG to provide records of about 80,000 “sham” events in which the government says doctors were wined and dined so they would prescribe the company’s cardiovascular drugs to their patients. The Swiss drugmaker and the Manhattan U.S. Attorney are engaged in a whistle-blower lawsuit that alleges Novartis provided illegal kickbacks to health-care providers through bogus educational programs at high-end restaurants and sports bars where the drugs were barely discussed. In a filing Friday, the U.S. said it needs Novartis to provide information to support its allegation that the company defrauded federal health-care programs of hundreds …

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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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