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Biotech / Medical : Biotech success, 2002 -- Ignore unavailable to you. Want to Upgrade?


To: Miljenko Zuanic who wrote (40)3/31/2002 10:19:32 PM
From: lizard lick  Respond to of 117
 
Industry shaker news on Medicare
You guys also might want to take a look at Titan Pharmaceuticals TTP 10k filing this weekend and check out what Novartis has found in their testing of titans iloperidone,, regarding dementia, very interesting. Also im wondering if you guys know of any other companies that might be affected by the billions that this press release below is indicating will be unleased for care.?

WASHINGTON, March 30 The Bush administration, in a major change, has authorized Medicare coverage for the treatment of Alzheimer's disease (news - web sites), which afflicts nearly four million Americans and is expected to grow to epidemic proportions with the aging of the population.

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The new policy means that Medicare beneficiaries can no longer be denied reimbursement for the costs of mental health services, hospice care or home health care just because they have Alzheimer's.

In the past, many claims were automatically denied on the assumption that treatment was futile because people with Alzheimer's were incapable of any medical improvement. Now, federal officials say, new studies show that people with Alzheimer's can often benefit from psychotherapy, physical and occupational therapy and other services.

"This is great news for people with Alzheimer's disease and other dementias," said Stephen R. McConnell, chief executive of the Alzheimer's Association. "The new policy should eliminate a form of discrimination against millions of people."

Neither federal officials nor advocates for the elderly provided estimates of the cost of the new policy. Experts said the direct cost to Medicare could be several billion dollars a year. But, they said, some of the cost could be offset by savings elsewhere in Medicare and Medicaid, because the new services will enable patients to live longer on their own, with greater ability to function.

The policy is set forth in a memorandum sent late last year from the government to the companies that review and pay Medicare claims. These companies have just begun to put the change into practice.

The government gave no public notice of the new policy, but it has already made a difference in the lives of some people with Alzheimer's. Some patients have received benefits that were once denied, and some medical practitioners have secured payment for services that Medicare once refused to cover.

The companies that review claims for the government, under federal contracts, are known as Medicare carriers. Most of them had programmed their computers to reject claims for people with Alzheimer's and other types of dementia. The new policy bans such computer software instructions and says contractors cannot deny claims simply because a person has Alzheimer's.

"Throughout the course of their disease," the memorandum says, "patients with dementia may benefit from pharmacologic, physical, occupational, speech-language and other therapies."

Patients' advocates, including the Alzheimer's Association and the American Bar Association, had supplied the government with dozens of research studies providing scientific evidence that such therapies were effective.

The government said it changed its policy because doctors and psychologists can now often diagnose Alzheimer's in its early stages, when patients are most likely to derive significant benefits from treatment and therapy. While there is no cure for Alzheimer's, staving off its worst effects can prolong a relatively normal life and save money.

It is not clear why the government did not publicize the new policy. Some officials apparently did not want to acknowledge that the old policy was, in effect, biased against people with Alzheimer's. When asked, a Medicare official said the change was not announced because "we saw it mainly as a technical matter for Medicare carriers."

Mr. McConnell of the Alzheimer's Association estimated that 10 percent of people over 65 and nearly half of those over 85 had Alzheimer's, a brain disorder that causes loss of memory, changes in personality and behavior, and a decline in thinking abilities.

Under the policy, Medicare will pay for more therapy and outpatient services. Dr. Steven T. DeKosky, a neurologist who directs the Alzheimer's Disease Research Center at the University of Pittsburgh, said these services would "keep people out of nursing homes," avoiding costs that would otherwise be borne by the government, patients or their families.

Kim A. Warchol, an occupational therapist in Itasca, Ill., who specializes in the treatment of people with Alzheimer's, said the new policy had major implications for patients, their spouses and their children.

"People with Alzheimer's will be able to live at home longer and avoid institutionalization," Ms. Warchol said. "Caregivers often assume that people with Alzheimer's are helpless. But we focus on their remaining physical and mental abilities, the things they can still do, and we find that many patients can perform activities of daily living if we provide appropriate cues or reminders of how to get started. They can dress themselves or groom themselves if you lay out their clothing or grooming supplies."

Margaret P. Norris, an associate professor of psychology at Texas A&M University, said that while Alzheimer's was irreversible and incurable, patients with mild to moderate forms of the disease could benefit from psychotherapy to help them cope with loss of memory and with feelings of depression and anxiety.

"We encourage patients to keep a notebook full of important information, like the names of their grandchildren, which they might forget," Ms. Norris said. "In later stages of Alzheimer's disease, it's common for patients to yell and scream and become aggressive. That may be because the environment is too noisy and distracting. We can sometimes modify the patient's behavior by changing the environment."

The impact of the new policy is illustrated by the experience of Jenni Lee Robins, 58, of Winter Haven, Fla., who used it to get treatment for her father, Harry H. Baker.

Mr. Baker, 78, has had Alzheimer's for eight years. After he was hospitalized and admitted to a nursing home last year, he received physical therapy, but it was ended after the nursing home concluded that his condition would not improve. He was hospitalized this year for pneumonia.

After learning of the new policy from a local chapter of the Alzheimer's Association, Ms. Robins used it to ensure that her father got "all the appropriate therapies" physical, occupational and respiratory.

"Daddy has improved tremendously because of the therapies Medicare now covers," Ms. Robins said. "He is in better condition now than before he went into the hospital this year. After eight days in the hospital, he lost the ability to walk, forgot how to walk. But after nine weeks of physical therapy, he can walk again."

People with Alzheimer's live an average of 8 to 10 years after the condition is diagnosed.

Dr. Paula E. Hartman-Stein, a clinical psychologist and founder of the Center for Healthy Aging in Kent, Ohio, said: "Previously, in many parts of the country, if a person had a diagnosis of dementia, the Medicare carrier would just arbitrarily, as a blanket policy, not cover psychological services. The new policy breaks down one of the major barriers to providing mental health services to elderly people."

Christina A. Metzler, director of federal affairs at the American Occupational Therapy Association, said the new policy was "tremendously significant" for patients. "In the past," she said, "a diagnosis of Alzheimer's could prevent a patient from getting Medicare coverage for therapy to treat other conditions a broken hip, a broken wrist or a stroke."

The new policy was adopted after two years of lobbying by the Alzheimer's Association and the American Bar Association's Commission on Legal Problems of the Elderly.

Leslie B. Fried, a lawyer at the commission, used the Freedom of Information Act to get copies of the local rules used by Medicare carriers in deciding whether to pay claims. These documents, she said, showed that "people with Alzheimer's were often being denied medically necessary services."



To: Miljenko Zuanic who wrote (40)4/1/2002 2:18:51 AM
From: Miljenko Zuanic  Read Replies (1) | Respond to of 117
 
It is device, but results are intriguing.

Thanks to Tech Master.

Thursday March 28, 9:30 am Eastern Time

Press Release

SOURCE: Celsion Corporation

Celsion Announces Phase II BPH Results

COLUMBIA, MD --(INTERNET WIRE)--Mar 28, 2002 -- CELSION CORPORATION (AMEX:CLN - news) announced today results from the multi-site Phase II pivotal trial of its Microfocus BPH 800 Microwave Urethroplasty(TM) system used for the treatment of Benign Prostatic Hyperplasia (BPH). BPH (commonly referred to as enlarged prostate) is a non-cancerous urological disease that affects many older men.
The pivotal clinical trial compared, after a three month treatment period, AUA symptom scores of patients who received one treatment with Celsion's Microwave Urethroplasty(TM) treatment system to patients treated with a daily 5mg dose of the drug PROSCAR®. AUA scores are the commonly accepted measurement of the level of severity of a patient's BPH symptoms. Developed by Merck (NYSE:MRK - news), PROSCAR® has been regularly prescribed to treat BPH since gaining FDA approval in 1992.

The trial demonstrated that patients undergoing Celsion's Microwave Urethroplasty(TM) treatment had achieved statistically significant greater reductions in their AUA symptom scores at each follow-up to date (two weeks, one month, and three months). In particular, 75% of the patients undergoing Microwave Urethroplasty(TM) experienced reductions in their AUA scores averaging in excess of 48% after two weeks, a significantly faster improvement than for the Proscar® patients who had not reached that result after three months. Moreover, over 90% experienced reductions averaging in excess of 50% after three months.

The clinical trial also demonstrated other patient benefits of Celsion's treatment system. First, only 18% of the patients undergoing Microwave Urethroplasty(TM) required any post-treatment catheterization compared to other microwave therapies that required 100% post-treatment catheterization during their clinical trials. Second, the procedures were performed on an outpatient basis, using topical analgesia and no sedation. Finally, Celsion's unique treatment system delivered much more rapid patient relief.

The Company also reported that it recently met with representatives of the Food and Drug Administration (FDA) to discuss Celsion's application for Pre-market approval (PMA) for the Microwave Urethroplasty(TM) system. The FDA indicated that it would continue to work with Celsion toward finalizing the first two modules of its PMA submission, which were submitted to the FDA on November 29, 2001. Celsion had previously indicated that it expected to file its third and final module based on three-month patient data at the end of March 2002. At the meeting, however, Celsion and the FDA concluded that the clinical modules should not be submitted until completion and closure of modules I and II.

Daniel Reale, President of Celsion's BPH Division, said, "The results of the trial exceeded our expectations. Patients experienced more rapid relief and fewer side effects. Importantly, our trial's success was measured against a major drug therapy. As the drug segment of this market, in the United States alone, consists of approximately two million men, many of whom are dissatisfied with their current treatment, this represents a huge opportunity for Celsion. Our system is designed to help physicians maximize the efficiency of their practices, and to offer patients a treatment that is office-based and provides rapid relief of their symptoms."

He added, "Although we are disappointed that we did not submit our clinical module based on three month data, these are excellent results. We believe the patient's AUA scores will get even better over time. As a result, we remain confident that when patient data is submitted, it will enable the FDA to take action on our application in an expeditious manner."

About Celsion: Celsion Corporation, based in Columbia, Maryland, is a research and development company dedicated to commercializing medical treatment systems for cancer and other diseases using focused heat technology delivered by patented microwave technology. Celsion has research, license or commercialization agreements with leading institutions such as Duke University Medical Center, Massachusetts Institute of Technology, Harbor UCLA Medical Center, the Center for Breast Surgery at Columbia Hospital in Florida, Montefiore Medical Center, Memorial Sloan Kettering Cancer Center in New York and Duke University. For more information on Celsion, visit our website: www.celsion.com.