February 22, 2012—The head of the Health Resources and Services Administration (HRSA) has written an open letter to 340B stakeholders describing actions both underway and in the works at her agency "to eliminate improper payments and reduce the risk of waste, fraud, and abuse" in the drug discount program. "Two of the most important responsibilities we have are to ensure … [Read more...]

February 17, 2012—The Centers for Medicare and Medicaid Services' (CMS) long-awaited proposed rule to implement health care reform's changes to the Medicaid drug rebate program would continue policies put in place late last year that have likely resulted in higher 340B prices for most covered outpatient drugs but lower 340B prices for the smaller class of so-called "5i" … [Read more...]

February 15, 2012—Dava Pharmaceuticals has agreed to pay 340B covered entities $185,557 as part of a settlement with the federal government and a whistleblower over charges that it violated the federal False Claims Act by misreporting drug prices in order to reduce its Medicaid drug rebate and 340B drug discount obligations. According to the Jan. 24 settlement, which the … [Read more...]

February 14, 2012—The Obama administration yesterday proposed giving the Secretary of Health and Human Services (HHS) the ability sometime after Oct. 1, 2013 to collect a fee of up to 0.5 percent, or 5 cents on every $10, on every 340B drug purchase in order to completely end line-item funding for the Office of Pharmacy Affairs' (OPA). The proposal was included in the … [Read more...]

February 10, 2012—The Office of Pharmacy Affairs (OPA) is holding a webinar at noon (Eastern) on Tuesday, Feb. 28 to explain in detail what hospitals must do to recertify their eligibility for the 340B program and to answer any questions that hospitals might have. Beginning in April, hospitals will be required to recertify that they meet all 340B eligibility requirements. … [Read more...]

February 6, 2012—In apparent response to urgent appeals by safety-net providers, drug manufacturer Sanofi U.S. has announced that it is reinstating patient assistance for its anti-coagulant Lovenox effective Feb. 15. The company discontinued its patient assistance program (PAP) for the widely used drug in late December. It also ended its entire institutional patient … [Read more...]

January 30, 2012—The Centers for Medicare and Medicaid Services (CMS) has published its long-awaited proposed rule to implement the Medicaid average manufacturer price (AMP) and best price (BP) provisions of the Affordable Care Act (ACA). Once finalized, the rule will have major implications for prices paid for 340B-discounted drugs. CMS is accepting comments on its proposal … [Read more...]