August 23, 2011—The Health Resources and Services Administration (HRSA) says it will issue proposed regulations in November for the calculation of 340B ceiling prices and for fines and other penalties against 340B covered entities that knowingly divert covered outpatient drugs. HRSA disclosed its timetable for issuing the two notices of proposed rulemaking (NPRM) in the … [Read more...]
Ex-PhRMA CEO Tauzin Joins Board of CaptureRx
Former U.S. congressman represented drug industry during health care reform debate.August 18, 2011—In a surprising transfer of allegiance, former U.S. Rep. Billy Tauzin, who led the nation's top drug industry group during the fight in Congress over health care reform, has joined the board of directors of 340B services company CaptureRx. Tauzin will also serve as CaptureRx's chief industry relations officer, in which capacity he will seek to maintain "an … [Read more...]
Appeals Court Strikes Down Health Reform’s Insurance Mandate
340B and Medicaid expansion are left intact, however.August 12, 2011—A federal appeals court has struck down the Affordable Care Act's mandate that all Americans purchase health insurance or pay a penalty, but said the rest of the law—including its expansion of the 340B program and Medicaid—could stand. Today's divided ruling by a three-judge panel of the 11th Circuit U.S. Court of Appeals increases the probability that the … [Read more...]
Manufacturers Criticize Proposed 340B Orphan Drug Exclusion Rule
HRSA's regulation, they say, would violate the law, couldn't be enforced and would harm R&D.Editors' note: This is the second in a series of articles on 340B stakeholders' reactions to an important proposed regulation to implement health care reform's limit on rural and free-standing cancer hospitals' access to 340B pricing on orphan drugs. In this installment, we focus on the drug industry's perspectives. August 11, 2011—A proposed federal regulation that would … [Read more...]
Hospitals and Lawmakers Back Proposed 340B Orphan Drug Exclusion Rule
HRSA's regulation reflects congressional intent and would improve access to needed drugs, they say.Editors' note: This is the last in a series of articles on 340B stakeholders' reactions to an important proposed regulation to implement health care reform's limit on rural and free-standing cancer hospitals' access to 340B pricing on orphan drugs. In this installment, we focus on the perspectives of two key lawmakers involved in drafting the orphan drug discount exception and … [Read more...]
Safety-Net Providers Ask NCPDP to Modify 340B Standards
Safeguards sought to protect them against reduced reimbursement.August 2, 2011—Health care providers enrolled in the 340B drug discount program will appeal in person next week to a National Council for Prescription Drug Programs (NCPDP) work group to change its standards so that pharmacy benefits managers (PBMs) and private payers cannot use them to lower reimbursement for 340B retail drugs. Groups representing hospitals, hemophilia … [Read more...]
Deficit Reduction Plan Cast Shadow Over Federal Health Programs
OPA's appropriation likely to be frozen or reduced.August 2, 2011—Federal Medicare reimbursement to health care providers, payments to state Medicaid programs, and spending to administer the 340B drug discount program could be significantly curtailed under a 10-year deficit reduction bill that President Obama signed into law today. The Senate voted 74-26 to approve the bill this morning after the House passed it 269-161 the … [Read more...]