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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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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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New ACA Rules Could Affect Hiring Decisions for Businesses

Aug 20, 2015 | | Corporate Governance, Health Law, Law, Legislation

Next year, a set of regulations under the Affordable Care Act will go into effect that could affect common hiring practices for many businesses. The “play or pay” rules mandate that an employer must offer coverage that is affordable and provides

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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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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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The Hill Publishes DCBA Op-Ed on National Rx Drug Abuse Summit

Apr 9, 2015 | | Drug policy, Health Law, Law, Legislation, Pharmaceuticals

On April 9, 2015, The Hill published Glimmer of Hope in Reducing Prescription Drug Abuse, written by Michael Barnes, the managing attorney for DCBA Law. The op-ed highlights the positive work of the National Rx Drug Abuse Summit, which is taking plac

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The Office of Inspector General Releases Advisory Opinion on Laboratory Waivers

Mar 31, 2015 | | Corporate Governance, Health Law, Law, Legislation, Pharmaceuticals

The Office of Inspector General (OIG) at the U.S. Department of Health and Human Services released an advisory opinion on March 25, 2015 detailing how a laboratory’s proposal to waive fees for certain patients referred by physician practices could

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Uninsured Pregnant Women Deserve Coverage

Mar 20, 2015 | | Corporate Governance, Health Law, Law, Legislation

Health care advocacy groups are arguing that uninsured women who become pregnant should be able to obtain health coverage at any time of the year through the Affordable Care Act’s health care exchanges. Numerous House Democrats called for pregnancy

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