October 10, 2013—The Health Resources and Services Administration (HRSA) Office of Pharmacy Affairs (OPA) canceled a 340B peer-to-peer network webinar yesterday in one of the first visible examples of the federal government shutdown's effect on the 340B program. … [Read more...]
PhRMA Sues to Block 340B Orphan Drug Rule
HRSA redefined the law and ignored congressional direction, group says(UPDATED Oct. 4, 2013 with comment from 340B hospitals.) October 2, 2013—Pharmaceutical Research and Manufacturers of America (PhRMA) filed suit in federal district court on Sept. 27 to stop the Department of Health and Human Services (HHS) and the Health Resources and Services Administration (HRSA) from implementing HRSA's regulation setting conditions under which critical … [Read more...]
Government Shutdown Shouldn’t Hamper 340B Enrollment, OPA Says
Online database, which is needed for registration, is expected to remain accessibleOctober 2, 2013—The Health Resources and Services Administration's (HRSA) Office of Pharmacy Affairs (OPA) says it believes that 340B stakeholders should be able to continue to use the 340B online database for the duration of the federal government shutdown that began yesterday. … [Read more...]
Senator Grassley Asks 2 Drug Companies About Denials of 340B Pricing
Seeks answers from CSL Behring and Pacira Pharmaceuticals by Oct. 9September 27, 2013—The Iowa Senator who has been looking into hospitals’ and a large retail pharmacy chain's participation in the 340B drug discount program has sent letters to two drug manufacturers asking why the companies are not providing discounts on particular products. … [Read more...]
Hospitals Complete 340B Recertification
56 of roughly 2,000 hospital parent sites did not reaffirm eligibility by Sept. 13 deadlineSeptember 19, 2013—Only 56 of the roughly 2,000 hospitals enrolled in the 340B drug discount program did not recertify their eligibility by a Sept. 13 deadline and will be removed from the program effective Oct. 1, an analysis of the Health Resources and Services Administration (HRSA) Office of Pharmacy Affairs (OPA) 340B covered entity database shows. … [Read more...]
Drug Company Attorneys Urge More Government Scrutiny of 340B
Manufacturers advised to begin thinking now about forthcoming "mega" regulationSeptember 18, 2013—Health care providers in the 340B drug discount program should be subject to far more government scrutiny and drug companies should have more power to look at 340B covered entities' books, attorneys who represent drug companies in 340B matters said during a major drug industry conference in Chicago last week. … [Read more...]
340B “Mega” Rule Will Exclude Some Program Elements
Items that Congress hasn't funded will be left out, Pedley saysSeptember 17, 2013—The forthcoming comprehensive regulation for the 340B drug discount program will not include provisions that Congress added to the program in 2010 but did not explicitly fund, Health Resources and Services Administration (HRSA) Office of Pharmacy Affairs (OPA) Director Cmdr. Krista Pedley said last week at a major meeting of drug manufacturers in Chicago. … [Read more...]