December 8, 2011—A second congressional committee in as many weeks has heard expert testimony on what is causing critical shortages of generic injectable drugs, including whether 340B drug discounts are part of the problem and, if so, to what degree. The Dec. 7 Senate Finance Committee hearing came just eight days after the one held by the House Oversight and Government … [Read more...]
Experts Link Medicare Reimbursement to Drug Shortages
Witnesses at House hearing disagree over whether 340B contributes to the problem.December 2, 2011—Witnessesses testifying before a U.S. House subcommittee largely agreed that Medicare pharmacy reimbursement is one of the core reasons behind critical shortages of generic injectable drugs, but they differed over whether 340B discounts are a factor. … [Read more...]
HRSA Issues Three 340B Policy Clarifications
Documents cover manufacturer audits, allocation procedures during shortages, and penny pricing.November 22, 2011—The Health Resources and Services Administration's (HRSA) Office of Pharmacy Affairs (OPA) issued three documents late yesterday clarifying its policies in three areas: manufacturer audits of 340B covered entities, procedures for allocating 340B-priced drugs in short supply, and the office's "penny pricing" policy when the statutory 340B ceiling price formula … [Read more...]
Deficit Reduction Supercommittee Falters
Funding for 340B program integrity efforts is still up in the air.November 22, 2011—The joint congressional committee tasked with developing a $1-billion-plus deficit reduction plan announced yesterday that it had failed to reach a deal. What the collapse of the Joint Select Committee on Deficit Reduction means for the 340B program is not completely clear. The panel's failure to reach a bipartisan consensus triggers approximately $1.2 … [Read more...]
Anticipated Bill Would Pause 340B Discounts on Some Shortage Drugs
Medicaid rebates on "medically necessary" drugs might also be halted for up to three years.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...]