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Rulings Help Address Confusion of 2009 Biosimilar Approval Pathway Law

Aug 20, 2015 | | Corporate Governance, Drug policy, Health Law, Law, Legislation, Pharmaceuticals

The Federal Circuit Court of Appeals issued two rulings related to the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), a law that established an abbreviated regulatory approval process for follow-on biological products, also ref

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Texas Hospital Strikes Back Against Insurance Company Lawsuit

Aug 20, 2015 | | Drug policy, Health Law, Law, Pharmaceuticals

Earlier this year, Aetna Life Insurance filed a lawsuit alleging that the North Cypress Medical Center in Texas engaged in several illegal practices to overcharge the insurance company $120 million since 2009. Recently, the hospital retaliated by rel

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HHS Rules Free Cancer Medication Plans Do Not Violate Anti-Kickback Laws

Aug 20, 2015 | | Corporate Governance, Drug policy, Health Law, Law, Legislation, Pharmaceuticals

The U.S. Department of Health and Human Services (HHS) Office of the Inspector General (OIG) recently released an advisory opinion that two drug-makers’ plans to offer free cancer treatments to patients whose insurance coverage has been delayed doe

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Four More Months To Meet the DSCSA’s Track and Trace Requirements

Jul 17, 2015 | | Drug policy, Health Law, Law, Legislation, Pharmaceuticals

FDA recently granted the pharmacies an additional four months to comply with federal track and trace requirements under the Drug Supply Chain Security Act (DSCSA). The DSCSA was enacted in 2013 to prevent and deter drug counterfeiting through the est

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Providers Should Implement Sound Procedures To Address Co-Pays and Deductibles

Jul 15, 2015 | | Drug policy, Pharmaceuticals

Providers can not only directly hurt their practice’s financial well-being by waiving co-pays and deductibles, but they may be committing insurance fraud and abuse as well. Andria Jacobs, the chief operating officer for PCG Software, writes that pa

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Antitrust Lawsuits Arise Against Health Insurance Giants

Jun 15, 2015 | | Drug policy, Health Law, Law, Pharmaceuticals

Multiple antitrust lawsuits in a federal court in Alabama allege that 37 independently owned Blue Cross and Blue Shield insurance plans have been conspiring to minimize competition, drive up prices for customers, and push down reimbursements to medic

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Growing Wave of Hep-C Infections Linked To Rx Drug Abuse

May 19, 2015 | | Drug policy, Health Law, Pharmaceuticals

According to a recent report from the Centers for Disease Control and Prevention (CDC), prescription opioid abuse appears to be what is fueling the growing number of hepatitis C infections in Kentucky, West Virginia, Tennessee, and Virginia. Between

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San Mateo County Addiction Treatment Centers are Negatively Affected by the ACA

Apr 21, 2015 | | Drug policy, Health Law, Law, Legislation

Multiple San Mateo County rehabilitation centers are struggling to implement and provide services put into law under the Affordable Care Act (ACA). Navigating the Medicaid system is a challenge for specialty providers, such as addiction treatment pra

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AIDS Healthcare Foundation Caught in $20 Million Kickback Scheme

Apr 21, 2015 | | Drug policy, Health Law, Law, Legislation, Pharmaceuticals

According to a lawsuit filed in South Florida federal court, the AIDS Healthcare Foundation, one of the nation’s largest suppliers of AIDS and HIV medical care, is accused of bilking Medicare and Medicaid in a $20 million scheme spanning twelve sta

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FDA Issues New Guidance on REMS Modifications and Revisions

Apr 10, 2015 | | Drug policy, Health Law, Law, Legislation, Media, Pharmaceuticals

This week, the U.S. Food and Drug Administration (FDA) issued new guidance on how pharmaceutical companies can change their Risk Evaluation and Mitigation Strategies (REMS)—plans that manage the known or potential serious risk associated with a par

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