July 3, 2014—Federal government and drug industry lawyers have discussed but been unable to agree on the terms of a cooperative resolution to the drugmakers' latest motion in their suit over the 340B orphan drug exclusion regulation, the government said in a July 2 filing in the case. … [Read more...]
340B Hospital Recertification Due to Begin Aug. 6
Hospitals will have five weeks to certify they are eligible and obey all requirementsJune 26, 2014—Hospitals will have from Aug. 6 through Sept. 10 to recertify their eligibility for the 340B drug discount program, the Health Resources and Services Administration announced during a webinar today. … [Read more...]
HRSA Posts Six More 340B Provider Audit Summaries for FY 2013
No adverse findings in five of the auditsJune 26, 2014—The Health Resources and Services Administration yesterday posted six more brief summaries of results from the 340B covered entity audits it conducted during fiscal year 2013. … [Read more...]
WSJ Scrutinizes Florida Oncology Practice
The Community Oncology Alliance has been slinging mud at 340B hospitals for months. Now, a Wall Street Journal investigation has found that a Florida oncology practice with close ties to COA racks up big dollars billing Medicare for the anemia drug Procrit, which "can speed tumor growth and hasten death in cancer patients." In fact, one-sixth of the $128 million that Medicare … [Read more...]
PhRMA Strikes Back at HRSA’s 340B Orphan Drug Policy Announcement
Drugmakers say the government is ignoring a court orderJune 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. … [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. … [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. … [Read more...]