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NIH announces government-sponsored clinical trial of H1N1 vaccine

BY DSN STAFF

NEW YORK There still is widespread concern over the safety and efficacy of the new H1N1 influenza vaccine, despite public assurances from executives at the highest levels of the Centers for Disease Control and Prevention — the point agency around the H1N1 pandemic — that the H1N1 vaccines have been subject to the same safety and efficacy protocols as seasonal vaccine, which generally is considered both safe and effective.

 

And the clinical trials that have been published to date show that the H1N1 vaccine, at the 15-microgram dose, works, even among children. Sanofi Pasteur late last week announced that clinical trials of its H1N1 vaccine in infants and children ages 6 months through 9 years was efficacious and only required one dose.

 

 

The NIH trial, though, is specifically exploring whether or not a 15-microgram dose provides adequate protection against asthmatics, or people with other upper respiratory chronic diseases, one of the high-priority groups identified by CDC for H1N1 influenza inoculation and a disease-state that may place sufferers at greater risk of complications from influenza. According to the American Lung Association, 7.6 million people in America have been diagnosed with chronic bronchitis; 3.7 million Americans will develop emphysema over the course of their lifetime; 6.7 million children have been diagnosed with pediatric asthma; and 8.4% of all adults report having adult asthma.

 

It’s important also because the prevalence of H1N1 influenza remains higher than expected influenza levels for this time of year and continues to be on the rise, even this early into the season.

Two weeks ago, a total of 37 states reported widespread influenza activity (which means that more than half of the counties have reported influenza activity)— only Washington, D.C., Hawaii and Vermont reported less than regional influenza activity (regional activity is more than one, but less than half of all counties have reported influenza activity; less than regional activity means only one county has reported influenza activity).

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Weis Markets reports EPS jump

BY Michael Johnsen

SUNBURY, Pa. Weis Markets reported a diluted earnings per share increase of 28 cents, compared with the same period one year ago, nearly doubling to 58 cents per share. During the thirteen-week period ended Sept. 26, the company’s net income increased 92.2% to $15.6 million, compared with the same period in 2008.

“At a time of changing customer spending patterns and during a period of considerable deflation in key categories, we continue to make significant progress in our core markets due to improved operating performance throughout our company,” stated Weis Markets’ president and CEO David Hepfinger. “We are encouraged with our results and hope to build on them in the fourth quarter.”

Third-quarter sales increased 3.2% to $623.2 million; comparable sales increased 1.1%.

In the third quarter, Weis Markets completed its acquisition of 11 stores in the Binghamton, N.Y. area on Aug. 23 and reopened the units Aug. 25, which contributed to a majority of the sales increase during the quarter.

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President gives pharmacies a delay as Medicare DME requirements loom

BY Jim Frederick

ALEXANDRIA, Va. The White House and Congress have given community pharmacies a little breathing room in their fight to overturn new and burdensome requirements on the sale of durable medical equipment and diabetic supplies under Medicare Part B. Now, pharmacy leaders are turning their attention to a permanent end to the DME challenge.

On Tuesday, President Obama signed into law a bill to delay until Jan. 1, 2010, a requirement that retail pharmacies obtain accreditation from the U.S. Centers for Medicare and Medicaid Services to continue selling DME and other health supplies to patients covered by Medicare Part B. Passage and enactment of the bill, H.R. 3663, drew strong praise today from both the chain and independent pharmacy lobby.

“We applaud President Obama for signing into law legislation that will extend the accreditation requirement for pharmacies to provide durable medical equipment in the Medicare Part B program until January 1, 2010,” noted Steven Anderson, president and CEO of the National Association of Chain Drug Stores. “The legislation will help ensure that Medicare beneficiaries can continue to obtain diabetic supplies, other DME products, and counseling from their trusted pharmacies and pharmacists.”

The new law, added the chain pharmacy leader, “will help avert serious disruptions in Medicare beneficiaries’ accessing critical medical supplies from their neighborhood pharmacy.”

Anderson sent a letter Thursday to Rep. Zach Space, D-Ohio, the author and lead sponsor of the bill, thanking him and pledging NACDS’ support for a permanent pharmacy exemption from the DME requirements.

Also weighing in Thursday was Bruce Roberts, EVP and CEO of the National Community Pharmacists Association. “Congress now has a three-month window to add pharmacists to all the other health care providers exempt from the time-consuming, costly, and redundant Medicare Part B DME accreditation requirement,” Roberts pointed out. “We remain hopeful for that outcome because both the House and Senate have included pharmacy exemption provisions in the healthcare reform proposals working their way through Congress.

“When this permanent solution is added to this temporary solution of a delay, seniors will be the ones who truly benefit,” added Roberts. “They will be able to continue getting these critical medical supplies, like diabetes testing strips, from their local pharmacy where many of their health care needs are being met. That allows seniors to can continue working with clinically trained pharmacists to get the best health outcomes possible.”

However, added the independent pharmacy advocate, “Without additional action, thousands of independent community pharmacies will be forced out of the program.”

Of particular concern to both NACDS and NCPA is an additional hurdle contained in new federal guidelines for the sale of DME and diabetic supplies. In addition to accreditation, new CMS rules also call for pharmacies to post additional insurance with Medicare – in the form of a $50,000 surety bond for each outlet – to continue supplying those products to Medicare Part B beneficiaries. Rep. Space also addressed that issue by introducing another piece of legislation, the Preserve Patient Access to Reputable DMEPOS Providers Act, which “would provide a conditional exemption for pharmacies from the surety bond requirement,” noted Anderson in his letter. However, he reminded the lawmaker, “While the House version of the healthcare reform bill includes a provision that waives the surety bond requirement for pharmacies enrolled as a supplier in Medicare Part B for the last five years that have never had an adverse action, the Senate Finance Committee bill only includes an exemption for pharmacies from the accreditation requirement.”

Anderson said chain pharmacy operators had several concerns about the new insurance requirement. Among them: that “the required bonded amount is on average several times greater than a pharmacy’s annual total DME sales,” that “the amount of bonding required would require pharmacies to exceed their bond capacity,” and that “Medicare Part B billing is a very burdensome process for pharmacies” even without the new insurance mandate. In addition, Anderson told Space, “DME is an extremely low-profit business for pharmacies and is a service they provide to their patients to help ensure that their diabetic patients are monitoring blood sugar levels properly.”

Last week, NACDS pointed out that 54 members of Congress have already co-signed a letter to acting CMS administrator Charlene Frizzera, requesting an immediate delay of the DME accreditation and $50,000 surety bond requirements for community pharmacies.

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