Mass. Medicaid Waiver Extended
The Centers for Medicare and Medicaid Services has granted Massachusetts a 3-year, $21.2 billion Medicaid waiver that will allow the state to continue to expand access to care through its health reform law. The agreement represents a $4.3 billion increase over the current waiver and fully preserves existing eligibility and benefit levels as well as federal matching funds for all government health insurance programs, Massachusetts Gov. Deval Patrick (D) said in a statement. The waiver allows the state to continue to subsidize health coverage for residents with incomes up to 300% of the poverty level. “In less than 2 years, health care reform in Massachusetts has made a difference,” he said. “Nearly 440,000 adults and children are newly insured and total system costs have begun to level off.”
Cephalon Pays $425 Million
Cephalon Inc. has agreed to pay more than $425 million to settle claims that it inappropriately marketed three drugs for off-label uses, according to the U.S. Justice Department. The settlement will resolve civil and criminal complaints alleging that the company marketed Gabitril (tiagabine), Actiq (oral transmucosal fentanyl), and Provigil (modafinil) for off-label uses. Between 2001 and 2006, Cephalon allegedly promoted Actiq, which is an approved pain treatment in opioid-tolerant cancer patients, as a treatment for migraine, sickle-cell pain, and injuries. Gabitril was allegedly promoted for treatment of anxiety, insomnia, and pain. Provigil, which was originally approved to treat excessive daytime sleepiness associated with narcolepsy, was allegedly promoted off-label as a nonstimulant drug for sleepiness, tiredness, decreased activity, and fatigue. Under the settlement, Cephalon has entered into a 5-year agreement with the Heath and Human Services Office of Inspector General that requires the company to notify physicians of the settlement terms and to begin disclosing any payments made to physicians on its Web site by Jan. 31, 2010.
Consumers Like Flat Rx Pricing
Pharmacy customers who take advantage of flat-rate generic prescription drug prices have higher levels of satisfaction than those who don't, according to the second annual J.D. Power and Associates National Pharmacy Study. Nearly one-fourth of pharmacy customers participate in a $4 generic or similar flat-rate pricing program, with the greatest participation rate among customers 44 years and older, the study said. Satisfaction among “bricks-and-mortar” pharmacy customers who participate in flat-rate prescription pricing programs averages 826 on a 1,000-point scale, compared with 817 among those customers who don't participate in the programs.
Nationwide RAC Launched
CMS has launched its national recovery audit contractor program as part of its “aggressive new steps to find and prevent waste, fraud and abuse in Medicare.” The new RACs, which will be paid on a contingency fee basis, soon will begin to contact providers about the program, CMS said. The 3-year RAC demonstration program in California, Florida, New York, Massachusetts, South Carolina, and Arizona collected more than $900 million in overpayments, according to CMS. However, the program has drawn strong criticism from physician groups, who have maintained that RAC audits were overly burdensome. In addition to implementing the RACs, CMS said it will begin to work directly with beneficiaries to make certain they receive the durable medical equipment or home health services for which Medicare has been billed, and that the items or services were medically necessary.
Many Drug Studies Unpublished
Studies on new prescription drugs are less likely to be published if they conclude that the medication is ineffective, researchers reported in the journal PLoS Medicine. The researchers found that only 43% of all clinical trials submitted to the Food and Drug Administration to support drug approvals between 1998 and 2000 had been published 5 years after the drug in question was approved. Among all the trials, those with statistically significant results were nearly twice as likely to have been published as those without statistically significant results, and pivotal trials were three times more likely to have been published as nonpivotal trials. But the study revealed “selective reporting” of results, the authors said. “A pivotal trial in which the new drug does no better than an old drug is less likely to be published than one where the new drug is more effective, a publication bias that could establish an inappropriately favorable record for the new drug in the medical literature,” the authors wrote.
Florida Files Vioxx Suit
Florida Attorney General Bill McCollum has sued Merck & Co. on behalf of state agencies he said were damaged by “the company's allegedly deceptive marketing and promotion” of Vioxx. The lawsuit follows a 3-year investigation of Merck's promotional practices of Vioxx (rofecoxib) and alleges that, because of the company's marketing practices, numerous Florida agencies approved the inclusion of Vioxx as a covered or approved drug. Vioxx purchases by the Florida Medicaid program exceeded $80 million between 1999 and 2004, according to McCollum, who argued that, if the facts about Vioxx had been known earlier, physicians and their Medicaid patients would have chosen other, less expensive prescriptions. Eight other states have filed similar lawsuits, according to Merck spokesman Ronald Rogers, who said in an interview that Merck acted responsibly on Vioxx and will defend against the suits.