June 19, 2014—The Health Resources and Services Administration acted "wholly at odds" with a federal district judge's orders when it announced yesterday that it stands by its interpretation of the 340B orphan drug exclusion, brand-name drugmakers argued in papers filed with the judge late on June 18. [ms-protect-content id="2799"] Pharmaceutical Research and Manufacturers of … [Read more...]
HRSA Begins Detailing How It’s Beefing up 340B Oversight
OPA's appears to be using much of its $6 million funding boost on provider complianceJune 19, 2014—The Health Resources and Services Administration has begun offering more details about how it is bolstering 340B program oversight with the extra $6 million Congress gave it for the drug discount program this fiscal year. [ms-protect-content id="2799"] HRSA has audited more than 200 covered entities during the past three years and, with the additional funding … [Read more...]
Judge Reaffirms Injunction Against California 340B Medicaid Carve-in Mandate
CMS approval of state plan amendment this year didn't alter court's conclusionsJune 18, 2014—A federal district judge today reaffirmed his May 2013 order permanently enjoining the state of California from enforcing a 2009 state law requiring 340B entities to "carve in" their Medicaid purchases and pass their 340B discounts on to the state by billing such drugs at no more than actual acquisition cost plus a dispensing fee.[ms-protect-content … [Read more...]
HRSA Will Stand by its 340B Orphan Drug Exclusion Regulation
Court didn't invalidate government's interpretation of statute, it assertsJune 18, 2014—The Health Resources and Services Administration announced this morning that it stands by its interpretation of the 340B orphan drug exclusion that lets critical access hospitals, sole community hospitals, rural referral centers, and free-standing cancer hospitals access 340B pricing on orphan drugs when they "are used for any indication other than treating the … [Read more...]
HHS Won’t Ask Judge to Take Second Look at 340B Orphan Drug Rule
Government might appeal and/or issue "interpretative" rule or guidanceJune 13, 2014—The Department of Health and Human Services has opted not to ask a federal district judge to uphold its 340B orphan drug exclusion regulation as an "interpretative" rather than "legislative" rule. [ms-protect-content id="2799"] The June 2013 orphan drug regulation said that, under language in the Affordable Care Act, rural and cancer hospitals could not get … [Read more...]
HRSA Opens Bidding for 340B Prime Vendor Program
Agreement will be for five yearsJune 11, 2014—The Health Resources and Services Administration has posted its request for submissions to manage the 340B Prime Vendor Program.[ms-protect-content id="2799"] The agreement will be for five years. The one it is replacing had two base years with three option years. Apexus, a nonprofit subsidiary of the health care supply chain company Novation, has been managing … [Read more...]
Drug Industry and Allies Call for Major 340B Changes at Summit
Hospitals reject meeting's premise that reform is direly neededJune 11, 2014—The 340B program should be reconfigured to directly benefit uninsured and otherwise needy patients instead of benefitting hospitals, several speakers said yesterday during a drug industry sponsored meeting on the drug discount program. Participants representing non-hospital 340B covered entities, however, cautioned against recasting 340B as a type of patient drug … [Read more...]