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CMS Takes Initial Steps to Address Medicare & Medicaid Coverage for Biosimilars

On March 30, 2015, CMS released guidance addressing Medicare and Medicaid coverage for biosimilar drug products. The Medicare/Medicaid coverage guidance comes on the heels of the FDA’s landmark approval of a biosimilar...more

Mother Nature Axes 340B Hearing, But Written Testimony Survives

Mother Nature claimed another victim this week. The U.S. House of Representatives Energy and Commerce Subcommittee on Health was scheduled to hold a hearing on March 5, 2015 – Examining the 340B Drug Pricing Program. But...more

What Indiana’s Medicaid Expansion Means For Other States

Last week, the Centers for Medicare & Medicaid Services (CMS) approved Indiana’s waiver under Section 1115 of the Social Security Act to implement Medicaid expansion, making it the 29th state (including the District of...more

Pharmacy Qui Tam Based On U&C Price Billing Survives Motion to Dismiss

Once again, a pharmacy employee has filed a qui tam involving a drug discount program, alleging that the failure of the pharmacy to use the discounted pricing as the “usual and customary” price in Medicaid and Medicare Part D...more

After Arkansas Supreme Court Reverses $1.2 Billion Medicaid False Claims Verdict, Will State Attorneys General Rethink the Use of...

On March 20, 2014, the Arkansas Supreme Court reversed a $1.2 billion judgment against Johnson & Johnson and its related companies over alleged Medicaid fraud stemming from the off-label marketing of the drug Risperdal. This...more

Does District Court Dismissal of Declined Qui Tam Threaten Future DOJ False Claims Enforcement?

The U. S. Department of Justice (DOJ) has taken the unusual step of appealing a federal district court’s dismissal of a declined qui tam brought under the federal and multiple state false claims acts (FCA). Could the...more

Texas Makes Changes to Medicaid Laws and Programs

Texas Governor Rick Perry signed a series of bills into law last week modifying some of the state’s Medicaid statutes and programs. The laws will take effect on September 1, 2013....more

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