February 20, 2013—Providers that have decided to use 340B-discounted drugs for their Medicaid patients need to have a mechanism in place to let state Medicaid officials know whenever they are unable to purchase a drug at its 340B price, the Health Resources and Services Administration (HRSA) says in a recent guidance document. The new notification requirement, announced … [Read more...]
Drug Industry and Allied Groups Want Rollback of 340B
Report says discounts should be more narrowly focused toward the uninsured poorFebruary 13, 2013—A coalition representing drug manufacturers, pharmacy benefit managers, private practice oncologists, and independent pharmacies issued a report yesterday on hospital participation in the 340B drug discount program, arguing that hospitals have strayed from what the groups maintain is 340B's purpose of helping the uninsured poor "gain better access to … [Read more...]
HRSA Clarifies Policy on 340B Hospitals’ Use of GPOs
Gives hospitals 60 days to change their drug purchasing methodologiesFebruary 8, 2013—Hospitals that use 340B covered outpatient drugs in departments that treat both inpatients and outpatients cannot buy drugs for such units at group purchasing organization (GPO) prices and then replenish their inventories with drugs bought at 340B prices, the Health Resources and Services Administration (HRSA) said yesterday. Hospitals have used this … [Read more...]
HRSA Reports on 18 Completed 340B Audits
Two providers had database inaccuracies but were not sanctionedFebruary 8, 2013—Sixteen out of the 18 federal 340B covered entity audits completed thus far found no violations of program requirements, the Health Resources and Services Administration (HRSA) reported today. Two audits—of a Texas health center and a Florida cancer hospital—found inaccuracies in the providers' entries in the 340B covered entity database, HRSA's Office of … [Read more...]
HRSA Issues Two 340B Policy Releases
Guidance documents address GPO prohibition and Medicaid exclusion fileFebruary 7, 2013—The Health Resources and Services Administration (HRSA) Office of Pharmacy Affairs (OPA) issued two 340B program policy releases this morning regarding (1) the prohibition against obtaining "covered outpatient drugs" through a group purchasing organization (GPO) for disproportionate share (DSH), children's, and free-standing cancer hospitals and (2) the use of … [Read more...]
OPA Asks 340B Hospitals About Botox Use
Known for smoothing wrinkles, drug is widely prescribed for multiple medical conditionsFebruary 7, 2013—The Office of Pharmacy Affairs (OPA) sent letters to 340B hospitals in late January requesting details about their use of the Allergan drugs Botox and Botox Cosmetic. Although Botox is perhaps best known for its cosmetic use, it is widely used medically to treat specific neuromuscular conditions affecting the upper limbs, eyes, and neck.[ms-protect-content … [Read more...]
HRSA Sends 340B Orphan Drug Final Rule to OMB for Clearance
Timetable for such reviews suggests regulation might be published by May 1February 4, 2013—The Health Resources and Services Administration (HRSA) has sent the White House Office of Management and Budget (OMB) its draft final regulation to clarify the Affordable Care Act’s (ACA) restriction on 340B discounts for orphan drugs purchased by hospitals that became eligible for 340B under health care reform. OMB's Office of Information and Regulatory … [Read more...]