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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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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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Federal Judge Strikes Down Maine’s Dangerous Foreign Importation Law

Feb 27, 2015 | | Corporate Governance, Drug policy, Health Law, Law, Legislation, Pharmaceuticals

On February 24, a federal judge struck down the Maine Pharmacy Act, which had allowed Maine residents to buy and import prescription drugs from pharmacies outside of the United States. U.S. District Court Judge Nancy Torreson ruled that Maine’s law

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Therapeutic Advances in Drug Safety Publishes DCBA Article on Abuse-Deterrent Formulations

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

Yesterday, Therapeutic Advances in Drug Safety digitally published Abuse-Deterrent Formulations: Transitioning the Pharmaceutical Market to Improve Public Health and Safety, authored by DCBA Law and Policy’s managing attorney Michael C. Barnes, ass

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Big Recovery from 2014 False Claims Act Litigation

Feb 19, 2015 | | Corporate Governance, Health Law, Law, Legislation

According to new statistics from the Department of Justice, the government has recovered approximately $5.7 billion from False Claims Act (FCA) litigation in 2014 and $23 billion since 2009. In 2014, nearly 4,000 new FCA matters were initiated. The v

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The Safe and Affordable Drugs from Canada Act is not so Safe

Feb 18, 2015 | | Corporate Governance, Drug policy, Health Law, Law, Legislation, Pharmaceuticals

On January 8, 2015, Senators John McCain (R-AZ) and Amy Klobuchar (D-MN) reintroduced the Safe and Affordable Drugs from Canada Act, a measure that would allow Americans to import prescription drugs from licensed pharmacies based in Canada. The bill

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How Can We Prevent Adverse Tiering?

Feb 18, 2015 | | Corporate Governance, Definitions, Drug policy, Health Law, Law, Pharmaceuticals

One of the Affordable Care Act’s main goals was to eliminate discrimination on the basis of preexisting conditions by requiring that all patients be insured and by instituting new age-adjusted community ratings for premiums. Yet, evidence suggests

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