January 30, 2015—The biotech company Celgene, acting at the request of the Health Resources and Services Administration, has posted a notice on the 340B program website explaining why it has stopped adding providers to its limited distribution networks for three of its products, including its top-selling blood cancer drug Revlimid. [ms-protect-content id="2799"] In the … [Read more...]
340B Recertification Underway for Health Centers and Most Grantees
Hospitals and Title X centers excluded from current batchJanuary 30, 2015—Annual recertification of 340B eligibility for all enrolled providers other than hospitals and Title X family planning clinics began on Jan. 28 and will end on March 11, according to a notice on the Health Resources and Services Administration Office of Pharmacy Affairs home page. [ms-protect-content id="2799"] Covered entities other than hospitals and … [Read more...]
HHS Asks Court to Dismiss 340B Orphan Drug Exclusion Lawsuit
Drug industry's response is due by Feb. 25January 29, 2015—Attorneys for the Department of Health and Human Services have asked a federal district judge to dismiss the drug industry's lawsuit against the 340B orphan drug exclusion interpretive rule. [ms-protect-content id="2799"] In a Jan. 27 motion, the Justice Department says that Pharmaceutical Research and Manufacturers of America's claims that the Health … [Read more...]
Hospital Uncompensated Care Costs Were a Record-High $46.4 Billion in 2013
Bad debt and charity care were 5.9 percent of expensesJanuary 29, 2015—U.S. hospitals provided $46.4 billion in uncompensated care in 2013, $500 million more than in 2012, the American Hospital Association reports. [ms-protect-content id="2799"] The new data come from the AHA's latest Annual Survey of Hospitals. The figure includes charity care and bad debt but excludes Medicaid and Medicare underpayment. The group reported … [Read more...]
21st Century Cures Draft Bill Released
Measure would extend exclusivity for several categories of drugsJanuary 28, 2015—The Republican chairman of the House Energy and Commerce Committee yesterday released the first draft of legislation to spur the development of disease-curing drugs, but the lead Democrat on what is called the 21st Century Cures Initiative declined to endorse the discussion document. [ms-protect-content id="2799"] One of the draft bill's many provisions … [Read more...]
Hospitals to Congress: Shield 340B from Cutbacks
Don't scale back drug discount program to pay for Medicare doc fix, AHA saysJanuary 23, 2015—Congress should not scale back the 340B drug discount program in an effort to pay part of the multi-billion-dollar cost of Medicare physician payment reform, the American Hospital Association told a House subcommittee yesterday in written testimony. Hospitals have faced more than $121 billion in federal spending cuts since 2010 and "now is not the time to … [Read more...]
41 Percent of “Novel New” Drugs Are for Rare Diseases
FDA report highlights drugmakers' affinity for orphan drugsJanuary 22, 2015—The Food and Drug Administration approved 41 "novel new" drugs in 2014, of which 17 – a record high – were for orphan diseases or conditions, the federal agency says in a new report. [ms-protect-content id="2799"] Hundreds of medicines are approved every year, most of them variations of drugs already on the market. The FDA reports annually on the small … [Read more...]