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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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The Health Insurance Premium for a Family Averages $25,572 in 2024 – KFF’s Annual Update on Employer-Sponsored Benefits

Health Populi

Prescription drugs (and costs) are on the minds of policymakers and legislators as well as prescribers, pharma companies, and payers — employers, government plans, health insurers and, of course, patients who co-pay or c0-share the costs of medicines. In 2024, the average patient share amounts are shown in Figure 9.6

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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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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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HHS, DOD and vendors partner for critical care via telehealth

Healthcare IT News - Telehealth

As part of the government-funded program, Avel eCARE also provided critical care consulting to a small community hospital that was inundated with COVID-19 patients. In 2004, Avel evolved to begin providing 24/7 on-demand services.

COVID-19 190
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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.