April 9, 2014—The Health Resources and Services Administration has sent its proposed 340B "mega-reg" to the White House Office of Management and Budget for review prior to its publication in the Federal Register, according to a notation today on the OMB website. … [Read more...]
HRSA Setting 60-Day Comment Period for 340B Mega-Reg
Agency would consider letting drugmakers audit providers at random, Pedley saysApril 2, 2014—Stakeholders will have 60 days to comment on the proposed 340B "mega-reg" that is still on track to be published in June, Office of Pharmacy Affairs Director Cmdr. Krista Pedley said at a drug industry conference last week. … [Read more...]
HRSA Replaces 340B Orphan Drug List for Second Quarter of 2014
Update removes drugs no longer having orphan designationsMarch 31, 2014—The Health Resources and Services Administration alerted 340B stakeholders by email this morning that on March 27 it posted a new version of its orphan drug designation list governing the second quarter of 2014 in order to address a problem in the version it posted on March 3. … [Read more...]
Another Bogus Study from Big Pharma
(UPDATE: Read a timely editorial on this subject in The Hill.) The pharmaceutical industry is again busy writing checks to friendly researchers to generate convenient data to attack the 340B program. This time the most profitable drug companies in the world are accusing hospitals of failing to provide adequate levels of charity care. A new report charges that only 20 percent … [Read more...]
Most 340B Hospitals Should Be Ousted From Program, Drug Industry-Led Group Suggests
Says study shows only about 20 percent "are doing it the right way"March 25, 2014—A drug-industry led coalition seeking major changes to the 340B drug discount program claimed today that relatively few 340B hospitals account for most of the charity care that all such hospitals provide. … [Read more...]
Rural America Needs 340B
If Big Pharma persuades Congress to limit or end the 340B program, "hardworking Americans in the heartland of the country will lose as hospitals cut back on prescription discounts, treatment and services," the head of the National Rural Health Association argues today in a commentary in the Capitol Hill newspaper Roll Call. "Many of our hospitals and clinics would have to … [Read more...]
HRSA Posts First 340B Provider Audit Summaries for FY13
No adverse findings in 10 out of 13 auditsMarch 21, 2014—The Health Resources and Services Administration today posted its first brief summary of results from 340B covered entity audits it conducted during fiscal year 2013. … [Read more...]