November 18, 2011—U.S. Sen. Orrin Hatch (R-Utah), the ranking Republican on the Senate Finance Committee and a senior member of the Health, Education, Labor and Pensions (HELP) Committee, reportedly is drafting legislation that would exclude "medically necessary" drugs that are in short supply from 340B discounts and Medicaid rebates for possibly up to three years, … [Read more...]
Congressional Democrats Seek Increased Medicaid Rebates
Proposal could lower 340B prices, increase savings.November 18, 2011—Congressional Democrats released a deficit reduction plan last week including a proposal to increase Medicaid rebates, which would save $20 billion over 10 years. The plan would increase the additional rebate manufacturers pay to Medicaid when a drug's average manufacturer price (AMP) increases by more than the rate of inflation. Such an increase in Medicaid … [Read more...]
U.S. Supreme Court Agrees to Hear Challenges to Health Care Reform
Ruling could have implications for Medicaid and 340B expansion.November 14, 2011—The U.S. Supreme Court today agreed to hear three lawsuits on the constitutionality of 2010's federal health care reform law, with a main area of focus on whether the entire law must be struck down if the Court invalidates the mandate that virtually all Americans obtain health insurance by 2014. The Affordable Care Act (ACA) included a major expansion of … [Read more...]
HRSA Says it Will Begin 340B Covered Entity Audits in February
Agency plans to send letter to manufacturers encouraging them to submit audit plans.November 11, 2011—The Health Resources and Services Administration (HRSA) plans to begin its first-ever audits of 340B covered entities beginning in February 2012 and to publish the results two to three months later, the agency revealed in response to questions from three influential Republican members of Congress. The agency also said it plans to send a policy letter to … [Read more...]
Senators Call for Hearing on Legislation to Alleviate Drug Shortages
Request closely follows President Obama's executive order broadening notification requirement.November 11, 2011—Four U.S. Senators yesterday called for a Senate hearing on possible legislative solutions to the growing problem of drug shortages. The letter by Sens. Amy Klobuchar (D-Minn.), Bob Casey (D-Pa.), Richard Blumenthal (D-Conn.) and Jeff Merkley (D-Ore.) to the Senate Health, Education, Labor and Pensions (HELP) Committee comes on the heels of President … [Read more...]
Grassley Warns of “Potential Abuse” of 340B Drug Discounts
Tells HRSA "to get a handle on" the program.November 9, 2011—The Health Resources and Services Administration (HRSA) "needs to get a handle on potential abuse" in the 340B drug discount program "before program growth gets out of hand, the taxpayers have to pay for it, and program sustainability is in question," the ranking Republican member of the U.S. Senate Judiciary Committee said today. Sen. Chuck Grassley … [Read more...]
HRSA to Ease Roadblock for Adding New 340B Outpatient Sites
Agency announces special policy exception to address cost reporting software delay.November 9, 2011—340B hospitals that have not been able to add outpatient facilities to the program because a form and software that they need for enrollment are still being developed can use last year's form and software instead, the Health Resources and Services Administration (HRSA) has decided. HRSA announced the "special exception policy" on the Office of Pharmacy … [Read more...]