PHARMACY

Pharmacy groups seek speedy hearing in bid to overturn Medicaid payment rules

BY Jim Frederick

ALEXANDRIA, Va. Ratcheting up their high-stakes legal campaign to halt the Bush Administration’s plan to dramatically cut Medicaid prescription reimbursements next year, chain and independent pharmacy leaders have asked a federal court to speed up its review of a lawsuit they filed last week.

In a motion filed jointly today in U.S. District Court for the District of Columbia, the National Association of Chain Drug Stores and the National Community Pharmacists Association sought an expedited review of a suit they filed Nov. 7 against the U.S. Department of Health and Human Services and the Centers for Medicare & Medicaid Services. The last-ditch legal action—which comes less than three months before a new Medicaid payment formula for generic drugs is set to go into effect Jan. 30, 2008—seeks an injunction against the imposition of the new payment plan.

The suit—which also names HHS Secretary Michael Leavitt and CMS acting administrator Kerry Weems—seeks to overturn the new reimbursement rule as a violation of laws governing Medicaid payments under the Social Security Act.

NACDS and NCPA are also asking the court to halt a CMS plan to publish “misleading” drug price information on a public web site.

CMS’ new reimbursement formula for generic prescriptions dispensed under Medicaid is based on the average manufacturer’s price of the generic drug, plus a dispensing fee. The government’s new payment program also includes a plan to publish the AMP-based prices of generics on the Internet.

The new reimbursement formula will force pharmacies to operate at a loss, the suit contends, and could lead to the disruption of service to Medicaid patients and even to the closing of many pharmacies.

In a joint statement issued today, NACDS president and chief executive officer Steve Anderson and NCPA executive vice president and chief executive officer Bruce Roberts cited the need for urgency. “In less than three months, the pending rule put forth by CMS will go into effect, resulting in drastic reimbursement cuts for retail pharmacies,” they noted. “The injunction seeks to obtain an expedited review of the lawsuit given the short time frame pharmacies are facing.

“We cannot stress enough the importance of a remedy that will allow low-income patients to have access to their medications,” the two industry group leaders added. “We continue to move forward with our two-prong approach—both legally and legislatively—in finding a remedy to these cuts. While we are hopeful to have a success in court, it is imperative to encourage Congress to work with community pharmacy to find more appropriate and long-term cost-based models for reimbursement under Medicaid.”

In support of the effort to halt the AMP-based payment plan, the motion also includes a new report on the possible economic impact the new plan could have on the nation’s community pharmacies. The author of the report, Stephen Schondelmeyer, contends that the Medicaid reimbursement cuts could devastate pharmacies that serve large populations of Medicaid patients in rural or inner-city urban areas.

Those cuts could lead to the loss of as many as 10,000 to 12,000 pharmacies nationwide, predicts Schondelmeyer.

“The economic report by Dr. Schondelmeyer, filed today, is further evidence of both the illegality and anticipated harm of the final CMS rule,” Anderson and Roberts asserted. “It is worth noting that CMS has relied on [his] expertise and analysis previously, having hired him to prepare six reports for the agency.”

Schondelmeyer, who heads the Department of Pharmaceutical Care & Health Systems at the College of Pharmacy at the University of Minnesota, also warned that “flawed data related to this rule might be published online as early as December 2007,” they noted.

“In general, transparency of price information is usually a good thing for consumers and for the market,” Schondelmeyer reported. “However, when disclosed information is complex, confusing, or even inaccurate, the transparency loses its value or even becomes counterproductive.”

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Scientists in Oklahoma are hopeful about Alzheimer’s vaccine

BY Allison Cerra

OKLAHOMA CITY Oklahoma City scientists have developed a vaccine that could restrain or even thwart Alzheimer’s Disease, according to The Oklahoman online.

The vaccine, designed to fight dementia in the brain via the human immune system, could reach human clinical trials in three to four years, according to officials at the Oklahoma Medical Research Foundation.

“These results are extremely exciting,” said Jordan Tang, OMRF researcher who led the laboratory study that resulted in the vaccine. “They certainly show that this vaccination approach warrants additional investigation as a therapy for Alzheimer’s disease.”

The illness, a fatal, memory-robbing disease, affects several million Americans, including 70,000 Oklahomans. November is National Alzheimer’s Disease Awareness Month.

Results of OMRF’s vaccine research appeared in the Oct. 21 edition of The Journal of the Federation of American Societies for Experimental Biology. “This is the first time this type of Alzheimer’s vaccine has been produced anywhere. Other types of vaccines have been tried, but have failed,” OMRF spokesman Adam Cohen said.

Tang had pointed out that while the vaccine should be an addition to developments to cure the disease, rather than a substitution, the vaccine is still in its critical stages.

Back 2002, the pharmaceutical company Elan halted trials of a different vaccine after 15 patients suffered swelling of the central nervous system. OMRF president, Dr. Stephen Prescott, said he’s hopeful Tang’s work will avoid the pitfalls that weighed down Elan’s vaccine. “This vaccination stimulates the immune system more gently than previous Alzheimer’s vaccines, so we are optimistic about its prospects going forward,” he said.

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Avastin study on pancreatic cancer effects mixed results

BY Allison Cerra

ZURICH , Switzerland A new late-stage study of Roche Holding’s Avastin, and its effectiveness to slow down or avert pancreatic cancer in patients, had mixed results, the company said Tuesday.

The Swiss drugmaker said that although the addition of its drug to a Tarceva-chemotherapy combination failed to prolong the lives of patients with advanced pancreatic cancer, certain subjects did have some benefits when using Avastin.

Roche said that the study, which included 607 patients, showed that adding Avastin prolonged the time patients lived without their cancer worsening, as well as adding safety benefits.

An earlier trial, the company said, utilizing the same experiment, concluded that the addition of Avastin had shown no benefit in the treatment of pancreatic cancer.

Roche, which sponsored the study known as AVITA, plans to further analyze the data to determine the extent of the benefit of adding Avastin to the Tarceva-chemotherapy combination. The new details that surfaced from the study will not be published, the drugmaker said.

Pancreatic cancer, deemed the most difficult form of cancer to treat, is frequently resistant to chemotherapy and radiotherapy, and tends to spread quickly to other parts of the body. It leads to the shortest life expectancy of any major tumor.

Avastin, which hinders the growth of tumors by restraining their blood supply, was jointly developed with Genentech, a U.S. biotechnology company (majority-owned by Roche), and is seen as one of Roche’s most important drugs.

Financial experts believe Avastin will eventually become Roche’s best-selling drug, according to Dow Jones, since the drug is expected to be approved to treat several types of cancers.

Avastin was first approved in the U.S. in 2004 for the treatment of advanced colorectal cancer, and was approved for the treatment of lung cancer one year later. It is currently awaiting sanction for use in breast cancer. In Europe, it won approval for the treatment of advanced breast cancer and lung cancer earlier this year.

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