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The Government Seeks FCA Liability for Off-Label Use of Medical Devices

Healthcare Law Blog

is a reminder that the government will use the FCA to target medical device manufacturers for off-label use of medical devices, even where healthcare providers have decided the use is safe and effective. The government is attempting to prove materiality using Medicare’s coverage requirement that procedures must be “reasonable and necessary.”

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Monthly Round-Up of What to Read on Pharma Law and Policy

Bill of Health

The selections feature topics ranging from a discussion of potential pathways to enable government patent use before nonpatent exclusivities expire, to an examination of medical oncologists who receive more than $100,000 annually from pharmaceutical companies, to an analysis of the launch prices of new drugs from 2008-2021. JAMA Intern Med.

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Biosafety Labs, Public Safety, and Politics

Bill of Health

dollars (USD) and additional government losses at $11 billion USD due to controlling livestock movement and depopulating infected livestock. The selection of the site was questioned by the Government Accountability Office. Or perhaps the site decision itself was an afterthought. By November of 2008, a new President was elected.

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Healthcare & Life Sciences Private Equity Deal Tracker: Thompson Street Invests in OpenClinica

McGuire Wood

Founded in 2004, the company supports biopharmaceutical companies, contract research organizations, academic institutions and government agencies. Thompson Street Capital Partners (TSCP) has announced it has completed a growth investment in OpenClinica. OpenClinica , based in Waltham, Mass., is a clinical research solutions provider.

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RLDatix to Acquire Porzio Life Sciences

HIT Consultant

Combined with RLDatix’s existing governance, risk, compliance (GRC) and workforce management offerings, Porzio Life Sciences broadens the company’s capabilities across life sciences and provides a comprehensive set of tools at global scale. – Financial details of the acquisition were not disclosed.

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Supreme Court Ruling Narrows Reach of Identity Theft Law

HIPAA Journal

The Supreme Court unanimously ruled that it could not support “such a boundless interpretation” of the Identity Theft Penalty Enhancement Act of 2004. Under the Government’s own reading, such cases are ‘automatically identity theft,’ independent of whether the name itself had anything to do with the fraudulent aspect of the offense.”

Fraud 107
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Conducting Internal Risk Adjustment Coding Audits

AIHC

This was originally mandated by the Centers for Medicare & Medicaid Services (CMS) back in 1997 and implemented in 2004. The OIG made the following recommendations to Humana: Refund to the Federal Government the $6.8 HCC coding relies on ICD-10-CM coding to assign risk scores to patients.