April 16, 2014—The chairman and four members of the Senate Select Committee on Aging are urging the White House budget chief—who also is President Obama's choice to be the next head of the Department of Health and Human Services—to uphold the "original core tenet" that the 340B program's purpose is "to help safety net providers reach more patients and provide more comprehensive … [Read more...]
The Anti-340B Lobby and Rising Medicare Costs
Expensive physician-administered biologic drugs for cancer and other diseases are helping to drive the cost of Medicare higher and higher, newspaper analyses of newly released Medicare billing data show. We note this with interest because biopharmaceutical companies that make these drugs, private cancer doctors who collect significant sums billing Medicare for them, and major … [Read more...]
HRSA Revises 340B Hospital Registration Instructions
Also outlines its process for reviewing hospitals' eligibilityApril 9, 2014—The Health Resources and Services Administration said yesterday that it has revised the instructions hospitals must follow to enroll themselves or their outpatient facilities in the 340B drug discount program. HRSA simultaneously published an outline of its process for ensuring that each applicant meets all requirements before it is deemed eligible. … [Read more...]
OMB Is Reviewing 340B Mega-Reg
Signs point to publication in early JulyApril 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. [ms-protect-content id="2799"] If the review takes the typical length of time and ends with OMB granting its … [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.[ms-protect-content id="2799"] In remarks at the annual Government Programs Summit for drug manufacturers' government contract specialists, … [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.[ms-protect-content id="2799"] According to the email message, drug manufacturers and … [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...]