We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
FDA Commissioner Mark McClellan could be in the running to lead the Centers for Medicare & Medicaid Services (CMS) — a critical position in the Bush administration’s efforts to institute far-reaching changes in the Medicare program, which includes prescription drug benefits approved by Congress last year.
Over the next two years, drugmakers will have to finesse the way they handle price breaks for large-volume purchasers in order to have those prices excluded from future reimbursement averages determined by legislators under the new Medicare Rx drug law.
As HHS implements the new Medicare reimbursement system for many physician-administered outpatient drugs, pharma firms are likely to find themselves confronted by many of the same fraud and abuse issues they have had to deal with under the much-criticized average wholesale price (AWP) system — as well as some new issues — according to a healthcare legal expert.
Vermont officials are generally doing a good job of controlling the state’s Medicaid drug rebate program, but they need to keep better track of whether drugmakers are paying the appropriate interest on late, disputed and unpaid rebates, according to the HHS Office of Inspector General (OIG).
Off-label promotion, long a target of FDA enforcement activities under the Food, Drug and Cosmetic Act, has been garnering increased attention as a potential violation of the False Claims Act — with far greater financial consequences — according to healthcare compliance experts.
Medicaid administrators in Montana need to improve the collection of rebates from drug manufacturers as well as the state’s accounts receivable system, according to a recent audit released by the HHS Office of Inspector General (OIG).
Drugmakers could face new marketing challenges as Medicare reduces reimbursement rates for certain outpatient drugs, cutting price spreads that created incentives for doctors to prescribe more expensive drugs.
HHS Secretary Tommy Thompson should use the department’s federal negotiating power to lower the costs of drugs under Medicare, according to a bipartisan group of 16 senators.
FDA authority will be tested for the first time under the 1994 Dietary Supplement Health and Education Act (DSHEA) in March as the agency girds itself against court challenges from supplement makers when a U.S. ban against ephedra goes into effect.
Montana Medicaid administrators need to better control the collection of rebates from drug manufacturers and improve the state’s accounts receivable system, according to a recent audit released by the HHS Office of Inspector General (OIG).