April 24, 2014—The nation's No. 1 and 2 producers of intravenous immune globulin, together with the Plasma Protein Therapeutics Association, are paying a combined $128 million to settle charges that they conspired to fix the prices of IVIG and the blood plasma derivative albumin that the companies sold directly to hospitals and other buyers between 2003 and 2009. … [Read more...]
Recent Court Decision May Affect Hospitals’ 340B Eligibility
Ruling involves how HHS calculates DSH adjustment percentages going back to 2004April 22, 2014—A federal appellate court has left open the possibility that the Secretary of Health and Human Services may calculate Medicare disproportionate share adjustment percentages going back 10 years in a way that disqualifies some hospitals for 340B drug discounts. … [Read more...]
AHA and Others Sue Over “Two-Midnight” Rule
Outcome could have implications for 340B programApril 16, 2014— The American Hospital Association and several hospital groups and individual hospitals have filed two lawsuits challenging the Centers for Medicare and Medicaid Services' “two-midnight” rule for deciding whether a patient is an inpatient for Medicare billing purposes. … [Read more...]
Senators to OMB & HRSA: Don’t Lose Sight of 340B’s Statutory Intent
Program exists to help providers reach more patients and provide more services, they sayApril 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...]
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. … [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...]