Joyce Frieden

WASHINGTON — One of the biggest barriers to guideline implementation is lack of a champion to encourage use of the guidelines at a particular institution, Dr. Rodger Winn said at a conference sponsored by Elsevier Oncology.

The idea of practice guidelines “is about as apple pie and motherhood as you can get,” said Dr. Winn, director of the Quality of Care Measures Project at the National Quality Forum (NQF), a nonprofit organization. “How can that not be translated into practice? Yet we know from a lot of studies that it hasn't happened.”

Several of the barriers to guideline use are fairly obvious, according to Dr. Winn. For instance, “if a guideline is too complex and you just can't follow it, it's not going to be used.”

There are patient-related barriers, as well. That can span everything from the recommended treatment not being paid for by the insurer to the recommendation being for radiation but the patient living 100 miles from the nearest radiation facility, he said.

Attitudinal barriers on the part of providers also are a problem. Providers may not agree with the guideline; the guideline may recommend something the provider doesn't believe he can accomplish; and the provider may not believe a particular guideline is going to work.

“If you don't believe the next monoclonal antibody really adds 3 months' median survival, you're not going to go along with it,” Dr. Winn said.

But one of the tougher barriers is clinical inertia—“you know it's sort of right but you don't do it anyway,” he said. “It's a well-known phenomenon in medicine.”

Randomized trials have shown that one way to overcome that inertia is to use “trusted leaders” to implement the guideline. “You literally have to go back to your own institutions and become champions for this,” Dr. Winn urged the audience.

He cited a clinical trial done in 16 Canadian hospitals in which some hospitals were assigned “audit and feedback” sessions regarding guidelines for repeat C-sections, while others also included an “opinion leader” to educate physicians about the new guideline. Those that used an opinion leader did much better at implementing the guideline (JAMA 1991;265:2202–7).

All the focus on guidelines is now leading up to quality measurement, Dr. Winn said. He noted that one expert split health care quality into three parts: structure (what's already in place, such as how many certified nurses you have); outcomes (what happens to the patient); and process (what you do to the patient that leads to those outcomes). “We'd like to say that outcomes are what ultimately define quality, but the problem is, it's not always as simple as that” because outcomes may vary for a variety of legitimate reasons. As a result, “outcomes in medicine may not be the proper measure of quality; it may be process. What did we do to the patient?”

Clinical practice guidelines, in fact, are process maps, he said. “They tell you what you should do to the patient. Therefore, if you measure adherence to guidelines, you're doing process measurement. The big assumption there is that the guidelines are valid and that these processes do lead to better outcomes.”

One question that is bound to come up more often as guidelines come into wider use is accountability. “Let's take breast-conserving surgery postop radiation therapy,” Dr. Winn said. “Is it the hospital's job to [make sure that] the patient got radiation after breast-conserving surgery? If you're at Memorial Sloan-Kettering and the patient goes back [home] to Queens, is that your job to make sure they got it? Which physician is in charge?”

Dr. Winn predicted two organizations will become increasingly prominent as guidelines proliferate: the NQF and the Cancer Quality Alliance. The NQF helps organizations decide which quality measures are worth using; its voluntary measure sets are already accepted by Medicare, “and we make sure that consumers, payers, health plans, and providers are there for a very formal review process,” he said. The Cancer Quality Alliance, set up by the American Society of Clinical Oncology and the National Coalition for Cancer Survivorship, “is still trying to define what its role is,” he said.

Elsevier Oncology and this newspaper are both wholly owned subsidiaries ofElsevier.

WASHINGTON — One of the biggest barriers to guideline implementation is lack of a champion to encourage use of the guidelines at a particular institution, Dr. Rodger Winn said at a conference sponsored by Elsevier Oncology.

The idea of practice guidelines “is about as apple pie and motherhood as you can get,” said Dr. Winn, director of the Quality of Care Measures Project at the National Quality Forum (NQF), a nonprofit organization. “How can that not be translated into practice? Yet we know from a lot of studies that it hasn't happened.”

Several of the barriers to guideline use are fairly obvious, according to Dr. Winn. For instance, “if a guideline is too complex and you just can't follow it, it's not going to be used.”

There are patient-related barriers, as well. That can span everything from the recommended treatment not being paid for by the insurer to the recommendation being for radiation but the patient living 100 miles from the nearest radiation facility, he said.

Attitudinal barriers on the part of providers also are a problem. Providers may not agree with the guideline; the guideline may recommend something the provider doesn't believe he can accomplish; and the provider may not believe a particular guideline is going to work.

“If you don't believe the next monoclonal antibody really adds 3 months' median survival, you're not going to go along with it,” Dr. Winn said.

But one of the tougher barriers is clinical inertia—“you know it's sort of right but you don't do it anyway,” he said. “It's a well-known phenomenon in medicine.”

Randomized trials have shown that one way to overcome that inertia is to use “trusted leaders” to implement the guideline. “You literally have to go back to your own institutions and become champions for this,” Dr. Winn urged the audience.

He cited a clinical trial done in 16 Canadian hospitals in which some hospitals were assigned “audit and feedback” sessions regarding guidelines for repeat C-sections, while others also included an “opinion leader” to educate physicians about the new guideline. Those that used an opinion leader did much better at implementing the guideline (JAMA 1991;265:2202–7).

All the focus on guidelines is now leading up to quality measurement, Dr. Winn said. He noted that one expert split health care quality into three parts: structure (what's already in place, such as how many certified nurses you have); outcomes (what happens to the patient); and process (what you do to the patient that leads to those outcomes). “We'd like to say that outcomes are what ultimately define quality, but the problem is, it's not always as simple as that” because outcomes may vary for a variety of legitimate reasons. As a result, “outcomes in medicine may not be the proper measure of quality; it may be process. What did we do to the patient?”

Clinical practice guidelines, in fact, are process maps, he said. “They tell you what you should do to the patient. Therefore, if you measure adherence to guidelines, you're doing process measurement. The big assumption there is that the guidelines are valid and that these processes do lead to better outcomes.”

One question that is bound to come up more often as guidelines come into wider use is accountability. “Let's take breast-conserving surgery postop radiation therapy,” Dr. Winn said. “Is it the hospital's job to [make sure that] the patient got radiation after breast-conserving surgery? If you're at Memorial Sloan-Kettering and the patient goes back [home] to Queens, is that your job to make sure they got it? Which physician is in charge?”

Dr. Winn predicted two organizations will become increasingly prominent as guidelines proliferate: the NQF and the Cancer Quality Alliance. The NQF helps organizations decide which quality measures are worth using; its voluntary measure sets are already accepted by Medicare, “and we make sure that consumers, payers, health plans, and providers are there for a very formal review process,” he said. The Cancer Quality Alliance, set up by the American Society of Clinical Oncology and the National Coalition for Cancer Survivorship, “is still trying to define what its role is,” he said.

Elsevier Oncology and this newspaper are both wholly owned subsidiaries ofElsevier.

WASHINGTON — One of the biggest barriers to guideline implementation is lack of a champion to encourage use of the guidelines at a particular institution, Dr. Rodger Winn said at a conference sponsored by Elsevier Oncology.

The idea of practice guidelines “is about as apple pie and motherhood as you can get,” said Dr. Winn, director of the Quality of Care Measures Project at the National Quality Forum (NQF), a nonprofit organization. “How can that not be translated into practice? Yet we know from a lot of studies that it hasn't happened.”

Several of the barriers to guideline use are fairly obvious, according to Dr. Winn. For instance, “if a guideline is too complex and you just can't follow it, it's not going to be used.”

There are patient-related barriers, as well. That can span everything from the recommended treatment not being paid for by the insurer to the recommendation being for radiation but the patient living 100 miles from the nearest radiation facility, he said.

Attitudinal barriers on the part of providers also are a problem. Providers may not agree with the guideline; the guideline may recommend something the provider doesn't believe he can accomplish; and the provider may not believe a particular guideline is going to work.

“If you don't believe the next monoclonal antibody really adds 3 months' median survival, you're not going to go along with it,” Dr. Winn said.

But one of the tougher barriers is clinical inertia—“you know it's sort of right but you don't do it anyway,” he said. “It's a well-known phenomenon in medicine.”

Randomized trials have shown that one way to overcome that inertia is to use “trusted leaders” to implement the guideline. “You literally have to go back to your own institutions and become champions for this,” Dr. Winn urged the audience.

He cited a clinical trial done in 16 Canadian hospitals in which some hospitals were assigned “audit and feedback” sessions regarding guidelines for repeat C-sections, while others also included an “opinion leader” to educate physicians about the new guideline. Those that used an opinion leader did much better at implementing the guideline (JAMA 1991;265:2202–7).

All the focus on guidelines is now leading up to quality measurement, Dr. Winn said. He noted that one expert split health care quality into three parts: structure (what's already in place, such as how many certified nurses you have); outcomes (what happens to the patient); and process (what you do to the patient that leads to those outcomes). “We'd like to say that outcomes are what ultimately define quality, but the problem is, it's not always as simple as that” because outcomes may vary for a variety of legitimate reasons. As a result, “outcomes in medicine may not be the proper measure of quality; it may be process. What did we do to the patient?”

Clinical practice guidelines, in fact, are process maps, he said. “They tell you what you should do to the patient. Therefore, if you measure adherence to guidelines, you're doing process measurement. The big assumption there is that the guidelines are valid and that these processes do lead to better outcomes.”

One question that is bound to come up more often as guidelines come into wider use is accountability. “Let's take breast-conserving surgery postop radiation therapy,” Dr. Winn said. “Is it the hospital's job to [make sure that] the patient got radiation after breast-conserving surgery? If you're at Memorial Sloan-Kettering and the patient goes back [home] to Queens, is that your job to make sure they got it? Which physician is in charge?”

Dr. Winn predicted two organizations will become increasingly prominent as guidelines proliferate: the NQF and the Cancer Quality Alliance. The NQF helps organizations decide which quality measures are worth using; its voluntary measure sets are already accepted by Medicare, “and we make sure that consumers, payers, health plans, and providers are there for a very formal review process,” he said. The Cancer Quality Alliance, set up by the American Society of Clinical Oncology and the National Coalition for Cancer Survivorship, “is still trying to define what its role is,” he said.

Elsevier Oncology and this newspaper are both wholly owned subsidiaries ofElsevier.

One morning a few months ago, Dr. Dan Murphy was awakened at 3 a.m. with news of a tragic case.

The patient, a 38-year-old man, had been operated on twice during childhood for a heart defect—once to get him stable and then again to fix the defect. Once he reached adolescence, however, he was lost to follow-up.

In the intervening years, he had developed a leaky valve, and his heart had gotten bigger and bigger. “His heart muscle had been damaged by being allowed to have that extra load all these years,” Dr. Murphy said. “He is probably going to either get a heart transplant or die.”

The real tragedy of the case, Dr. Murphy said, was that “I think a lot of the problem could have been prevented if he had been seen earlier.”

It's these kinds of cases that Dr. Murphy has in mind as he works to expand Stanford (Calif.) University's Adult Congenital Heart Clinic.

Because of the success of pediatric cardiac care, many patients who would have died from their heart defects are now living well into adulthood. Long-term studies of these patients have shown that they often have few problems for the next 10 or 15 years.

However, “We've found that longer term, we start to see things develop,” said Dr. Murphy, director of the clinic.

Part of that is simply a result of changes associated with aging, he continued.

“We get older and middle age has its effects on all of us, including people with heart defects. We see rhythm changes, we see cardiac muscle failure in some populations, and we see changes in valves that were functioning before that begin to deteriorate.”

Some of these patients continue to see their pediatric cardiologists until they are well into their 30s, while others see general cardiologists, Dr. Murphy said. But some patients with milder defects may not end up seeing anyone at all.

The ideal background for physicians taking care of these patients is “they need to be trained in pediatric cardiology as well as adult medicine and adult cardiology,” said Dr. Mary Mullen, staff cardiologist at Boston Children's Hospital as well as at the Boston Adult Congenital Heart Service. “Backgrounds tend to vary. I personally trained in medicine and pediatrics.”

To start figuring out a road map for the specialty, the American College of Cardiology sponsored a conference in Bethesda, Md., in October 2000, which resulted in an article addressing coordination of care, educational requirements, access to care, and special needs of adult congenital heart disease patients (J. Am. Coll. Cardiol. 2001;37:1161–98; www.acc.org

In 2004, the ACC formed the Congenital Heart Disease and Pediatric Cardiology section, “To provide a resource for all cardiovascular specialists who are involved in the care of pediatric and adult patients with congenital heart disease.”

The case of Amy Verstappen, a patient with congenitally corrected transposition of the great arteries, is a perfect example of why treating physicians need sophisticated backgrounds. “Two years after the birth of my daughter, I started having some fatigue and was misdiagnosed as having dilated cardiomyopathy,” said Ms. Verstappen, who is president of the Adult Congenital Heart Association, a patient organization. “I kept saying I had this defect and they kept saying, 'It doesn't matter. Your only option is a transplant.'”

The irony of that diagnosis, she continued, “was that I had a normal heart size—no one had done a chest x-ray. And the echocardiogram was getting really bad ejection fraction numbers, which were inaccurate.”

Once she got to a specialist, Ms. Verstappen found out that she never had dilated cardiomyopathy and that she could have tricuspid valve replacement instead of a transplant. “I had the valve replacement and I've been stable since.”

Several of the physicians Ms. Verstappen saw remarked that she had a “funny” mitral valve. But that was because they were actually looking at the tricuspid valve, she noted. Reflecting on the treatment she got before she saw a specialist in this area, Ms. Verstappen said, “I'm not mad at [the doctors who misdiagnosed me], but I think people can do a better job of getting a referral when somebody with a complex disease comes along.”

Dr. Murphy agreed. “It's a continuing education problem,” he said. “The patients have a right to see a specialist who stays up to date and who's well trained and experienced. A specialized center like this, and the cardiologists who work in it, serve as education resources not just for the patient, but also for the primary care physician and for the local cardiologist, especially in the case of patients who come a long way. They can see their regular cardiologist for most things, and get a reassessment from us” when needed.

But first, cardiologists need to learn which patients to refer. To help them figure that out, Dr. Roberta Williams, chairman of pediatrics at Children's Hospital of Los Angeles, and Dr. Carol Warnes, professor of medicine at the Mayo Clinic in Rochester, Minn., are developing guidelines for cardiologists on how to manage adult congential heart disease patients.

“It's sort of a cookbook, to give them a handle on what they should be looking for, what should trigger a referral to a specialized center, and what are the long-term outcomes,” Dr. Williams said.

The guidelines, which Dr. Williams said would be available in about a year, are being cosponsored by the ACC and the American Heart Association.

In some geographic areas, “the best expertise [in this area] is in the children's hospital, because the anesthesiologists and the cardiologists there are best trained to manage these patients,” Dr. Mullen said.

Some cardiologists are starting to get the message.

Dr. Murphy said his clinic sees about 10 patients a week, most of whom are complex and require long visits.

Dr. Joseph Perloff, founding director of the Adult Congenital Heart Disease Center at the University of California, Los Angeles, also has seen demand grow at his facility. “It was apparent decades ago that advances in surgical techniques in congenital heart disease would result in long-term survival, and there were no facilities or training programs” to help these patients, he said.

So Dr. Perloff started the center shortly after he arrived at UCLA in 1979; the center was initially open only 1 day a week. Today it is open 4 days a week and has a registry of almost 3,000 patients, most of them referred by cardiologists in the community. The Adult Congenital Heart Association, in conjunction with the International Society of Adult Congenital Heart Disease, is putting together a directory of self-described adult congenital heart clinics nationwide; so far, they have received 37 surveys from centers that describe themselves as such, according to Ms. Verstappen.

UCLA also has the first and largest training program for the specialty; the program admits one or two fellows per year, depending on the strength of the applicant pool, Dr. Perloff said.

Physicians may apply for the fellowship after they finish residency, which must include 2 years in general cardiology and some pediatric cardiology as well. The fellowship lasts 1 year, “but usually the fellows stay on another year to complete a research study or develop a particular area of interest,” he noted.

Other training programs include those at the University of California, San Francisco, the Mayo Clinic, the University of Iowa, Iowa City, and the University of Pennsylvania, Philadelphia. But more need to be started, Dr. Perloff said.

He noted that currently there are only about 1,200 board-certified pediatric cardiologists, far too few to take care of the estimated 900,000 adults with congenital heart disease nationwide.

In fact, “there are now more adults with congenital heart disease than infants and children,” he said.

One problem with recruiting people into training programs is that for cardiologists, “training is already very long” with 4 years of residency and 2 years of specialty training, Dr. Williams said.

“To sustain this kind of [subspecialty] training, other aspects of training may need to be shortened, maybe by double-counting certain things, or having a loan forgiveness program or something to help them, because if you delay starting practice for 2 more years, the debt burden is so high a lot of them wouldn't be able to afford to do it,” she said.

This situation is not helped by the fact that many adult congenital heart disease patients have trouble getting health insurance. Coverage for these patients under their parents' insurance policies typically stops when they turn 18 or 21.

“How many 19-year-olds working at whatever job someone that age can have, will have health insurance?” Dr. Williams said. Treating uninsured or underinsured patients then adds to the physicians' financial woes.

To bring more attention to the issues surrounding these patients, the Adult Congenital Heart Association and several other organizations sponsored a “lobby day” in Washington on Feb. 8, aimed in part at getting Congress to fund a registry of congenital heart disease patients.

“We need basic data to help us plan for the needs of adults with congenital heart disease. We need to do evidence-based medicine,” Ms. Verstappen said. “We also want to help children with congenital heart disease. Right now, we are doing surgeries in children without the data we could have from adults.”

One morning a few months ago, Dr. Dan Murphy was awakened at 3 a.m. with news of a tragic case.

The patient, a 38-year-old man, had been operated on twice during childhood for a heart defect—once to get him stable and then again to fix the defect. Once he reached adolescence, however, he was lost to follow-up.

In the intervening years, he had developed a leaky valve, and his heart had gotten bigger and bigger. “His heart muscle had been damaged by being allowed to have that extra load all these years,” Dr. Murphy said. “He is probably going to either get a heart transplant or die.”

The real tragedy of the case, Dr. Murphy said, was that “I think a lot of the problem could have been prevented if he had been seen earlier.”

It's these kinds of cases that Dr. Murphy has in mind as he works to expand Stanford (Calif.) University's Adult Congenital Heart Clinic.

Because of the success of pediatric cardiac care, many patients who would have died from their heart defects are now living well into adulthood. Long-term studies of these patients have shown that they often have few problems for the next 10 or 15 years.

However, “We've found that longer term, we start to see things develop,” said Dr. Murphy, director of the clinic.

Part of that is simply a result of changes associated with aging, he continued.

“We get older and middle age has its effects on all of us, including people with heart defects. We see rhythm changes, we see cardiac muscle failure in some populations, and we see changes in valves that were functioning before that begin to deteriorate.”

Some of these patients continue to see their pediatric cardiologists until they are well into their 30s, while others see general cardiologists, Dr. Murphy said. But some patients with milder defects may not end up seeing anyone at all.

The ideal background for physicians taking care of these patients is “they need to be trained in pediatric cardiology as well as adult medicine and adult cardiology,” said Dr. Mary Mullen, staff cardiologist at Boston Children's Hospital as well as at the Boston Adult Congenital Heart Service. “Backgrounds tend to vary. I personally trained in medicine and pediatrics.”

To start figuring out a road map for the specialty, the American College of Cardiology sponsored a conference in Bethesda, Md., in October 2000, which resulted in an article addressing coordination of care, educational requirements, access to care, and special needs of adult congenital heart disease patients (J. Am. Coll. Cardiol. 2001;37:1161–98; www.acc.org

In 2004, the ACC formed the Congenital Heart Disease and Pediatric Cardiology section, “To provide a resource for all cardiovascular specialists who are involved in the care of pediatric and adult patients with congenital heart disease.”

The case of Amy Verstappen, a patient with congenitally corrected transposition of the great arteries, is a perfect example of why treating physicians need sophisticated backgrounds. “Two years after the birth of my daughter, I started having some fatigue and was misdiagnosed as having dilated cardiomyopathy,” said Ms. Verstappen, who is president of the Adult Congenital Heart Association, a patient organization. “I kept saying I had this defect and they kept saying, 'It doesn't matter. Your only option is a transplant.'”

The irony of that diagnosis, she continued, “was that I had a normal heart size—no one had done a chest x-ray. And the echocardiogram was getting really bad ejection fraction numbers, which were inaccurate.”

Once she got to a specialist, Ms. Verstappen found out that she never had dilated cardiomyopathy and that she could have tricuspid valve replacement instead of a transplant. “I had the valve replacement and I've been stable since.”

Several of the physicians Ms. Verstappen saw remarked that she had a “funny” mitral valve. But that was because they were actually looking at the tricuspid valve, she noted. Reflecting on the treatment she got before she saw a specialist in this area, Ms. Verstappen said, “I'm not mad at [the doctors who misdiagnosed me], but I think people can do a better job of getting a referral when somebody with a complex disease comes along.”

Dr. Murphy agreed. “It's a continuing education problem,” he said. “The patients have a right to see a specialist who stays up to date and who's well trained and experienced. A specialized center like this, and the cardiologists who work in it, serve as education resources not just for the patient, but also for the primary care physician and for the local cardiologist, especially in the case of patients who come a long way. They can see their regular cardiologist for most things, and get a reassessment from us” when needed.

But first, cardiologists need to learn which patients to refer. To help them figure that out, Dr. Roberta Williams, chairman of pediatrics at Children's Hospital of Los Angeles, and Dr. Carol Warnes, professor of medicine at the Mayo Clinic in Rochester, Minn., are developing guidelines for cardiologists on how to manage adult congential heart disease patients.

“It's sort of a cookbook, to give them a handle on what they should be looking for, what should trigger a referral to a specialized center, and what are the long-term outcomes,” Dr. Williams said.

The guidelines, which Dr. Williams said would be available in about a year, are being cosponsored by the ACC and the American Heart Association.

In some geographic areas, “the best expertise [in this area] is in the children's hospital, because the anesthesiologists and the cardiologists there are best trained to manage these patients,” Dr. Mullen said.

Some cardiologists are starting to get the message.

Dr. Murphy said his clinic sees about 10 patients a week, most of whom are complex and require long visits.

Dr. Joseph Perloff, founding director of the Adult Congenital Heart Disease Center at the University of California, Los Angeles, also has seen demand grow at his facility. “It was apparent decades ago that advances in surgical techniques in congenital heart disease would result in long-term survival, and there were no facilities or training programs” to help these patients, he said.

So Dr. Perloff started the center shortly after he arrived at UCLA in 1979; the center was initially open only 1 day a week. Today it is open 4 days a week and has a registry of almost 3,000 patients, most of them referred by cardiologists in the community. The Adult Congenital Heart Association, in conjunction with the International Society of Adult Congenital Heart Disease, is putting together a directory of self-described adult congenital heart clinics nationwide; so far, they have received 37 surveys from centers that describe themselves as such, according to Ms. Verstappen.

UCLA also has the first and largest training program for the specialty; the program admits one or two fellows per year, depending on the strength of the applicant pool, Dr. Perloff said.

Physicians may apply for the fellowship after they finish residency, which must include 2 years in general cardiology and some pediatric cardiology as well. The fellowship lasts 1 year, “but usually the fellows stay on another year to complete a research study or develop a particular area of interest,” he noted.

Other training programs include those at the University of California, San Francisco, the Mayo Clinic, the University of Iowa, Iowa City, and the University of Pennsylvania, Philadelphia. But more need to be started, Dr. Perloff said.

He noted that currently there are only about 1,200 board-certified pediatric cardiologists, far too few to take care of the estimated 900,000 adults with congenital heart disease nationwide.

In fact, “there are now more adults with congenital heart disease than infants and children,” he said.

One problem with recruiting people into training programs is that for cardiologists, “training is already very long” with 4 years of residency and 2 years of specialty training, Dr. Williams said.

“To sustain this kind of [subspecialty] training, other aspects of training may need to be shortened, maybe by double-counting certain things, or having a loan forgiveness program or something to help them, because if you delay starting practice for 2 more years, the debt burden is so high a lot of them wouldn't be able to afford to do it,” she said.

This situation is not helped by the fact that many adult congenital heart disease patients have trouble getting health insurance. Coverage for these patients under their parents' insurance policies typically stops when they turn 18 or 21.

“How many 19-year-olds working at whatever job someone that age can have, will have health insurance?” Dr. Williams said. Treating uninsured or underinsured patients then adds to the physicians' financial woes.

To bring more attention to the issues surrounding these patients, the Adult Congenital Heart Association and several other organizations sponsored a “lobby day” in Washington on Feb. 8, aimed in part at getting Congress to fund a registry of congenital heart disease patients.

“We need basic data to help us plan for the needs of adults with congenital heart disease. We need to do evidence-based medicine,” Ms. Verstappen said. “We also want to help children with congenital heart disease. Right now, we are doing surgeries in children without the data we could have from adults.”

One morning a few months ago, Dr. Dan Murphy was awakened at 3 a.m. with news of a tragic case.

The patient, a 38-year-old man, had been operated on twice during childhood for a heart defect—once to get him stable and then again to fix the defect. Once he reached adolescence, however, he was lost to follow-up.

In the intervening years, he had developed a leaky valve, and his heart had gotten bigger and bigger. “His heart muscle had been damaged by being allowed to have that extra load all these years,” Dr. Murphy said. “He is probably going to either get a heart transplant or die.”

The real tragedy of the case, Dr. Murphy said, was that “I think a lot of the problem could have been prevented if he had been seen earlier.”

It's these kinds of cases that Dr. Murphy has in mind as he works to expand Stanford (Calif.) University's Adult Congenital Heart Clinic.

Because of the success of pediatric cardiac care, many patients who would have died from their heart defects are now living well into adulthood. Long-term studies of these patients have shown that they often have few problems for the next 10 or 15 years.

However, “We've found that longer term, we start to see things develop,” said Dr. Murphy, director of the clinic.

Part of that is simply a result of changes associated with aging, he continued.

“We get older and middle age has its effects on all of us, including people with heart defects. We see rhythm changes, we see cardiac muscle failure in some populations, and we see changes in valves that were functioning before that begin to deteriorate.”

Some of these patients continue to see their pediatric cardiologists until they are well into their 30s, while others see general cardiologists, Dr. Murphy said. But some patients with milder defects may not end up seeing anyone at all.

The ideal background for physicians taking care of these patients is “they need to be trained in pediatric cardiology as well as adult medicine and adult cardiology,” said Dr. Mary Mullen, staff cardiologist at Boston Children's Hospital as well as at the Boston Adult Congenital Heart Service. “Backgrounds tend to vary. I personally trained in medicine and pediatrics.”

To start figuring out a road map for the specialty, the American College of Cardiology sponsored a conference in Bethesda, Md., in October 2000, which resulted in an article addressing coordination of care, educational requirements, access to care, and special needs of adult congenital heart disease patients (J. Am. Coll. Cardiol. 2001;37:1161–98; www.acc.org

In 2004, the ACC formed the Congenital Heart Disease and Pediatric Cardiology section, “To provide a resource for all cardiovascular specialists who are involved in the care of pediatric and adult patients with congenital heart disease.”

The case of Amy Verstappen, a patient with congenitally corrected transposition of the great arteries, is a perfect example of why treating physicians need sophisticated backgrounds. “Two years after the birth of my daughter, I started having some fatigue and was misdiagnosed as having dilated cardiomyopathy,” said Ms. Verstappen, who is president of the Adult Congenital Heart Association, a patient organization. “I kept saying I had this defect and they kept saying, 'It doesn't matter. Your only option is a transplant.'”

The irony of that diagnosis, she continued, “was that I had a normal heart size—no one had done a chest x-ray. And the echocardiogram was getting really bad ejection fraction numbers, which were inaccurate.”

Once she got to a specialist, Ms. Verstappen found out that she never had dilated cardiomyopathy and that she could have tricuspid valve replacement instead of a transplant. “I had the valve replacement and I've been stable since.”

Several of the physicians Ms. Verstappen saw remarked that she had a “funny” mitral valve. But that was because they were actually looking at the tricuspid valve, she noted. Reflecting on the treatment she got before she saw a specialist in this area, Ms. Verstappen said, “I'm not mad at [the doctors who misdiagnosed me], but I think people can do a better job of getting a referral when somebody with a complex disease comes along.”

Dr. Murphy agreed. “It's a continuing education problem,” he said. “The patients have a right to see a specialist who stays up to date and who's well trained and experienced. A specialized center like this, and the cardiologists who work in it, serve as education resources not just for the patient, but also for the primary care physician and for the local cardiologist, especially in the case of patients who come a long way. They can see their regular cardiologist for most things, and get a reassessment from us” when needed.

But first, cardiologists need to learn which patients to refer. To help them figure that out, Dr. Roberta Williams, chairman of pediatrics at Children's Hospital of Los Angeles, and Dr. Carol Warnes, professor of medicine at the Mayo Clinic in Rochester, Minn., are developing guidelines for cardiologists on how to manage adult congential heart disease patients.

“It's sort of a cookbook, to give them a handle on what they should be looking for, what should trigger a referral to a specialized center, and what are the long-term outcomes,” Dr. Williams said.

The guidelines, which Dr. Williams said would be available in about a year, are being cosponsored by the ACC and the American Heart Association.

In some geographic areas, “the best expertise [in this area] is in the children's hospital, because the anesthesiologists and the cardiologists there are best trained to manage these patients,” Dr. Mullen said.

Some cardiologists are starting to get the message.

Dr. Murphy said his clinic sees about 10 patients a week, most of whom are complex and require long visits.

Dr. Joseph Perloff, founding director of the Adult Congenital Heart Disease Center at the University of California, Los Angeles, also has seen demand grow at his facility. “It was apparent decades ago that advances in surgical techniques in congenital heart disease would result in long-term survival, and there were no facilities or training programs” to help these patients, he said.

So Dr. Perloff started the center shortly after he arrived at UCLA in 1979; the center was initially open only 1 day a week. Today it is open 4 days a week and has a registry of almost 3,000 patients, most of them referred by cardiologists in the community. The Adult Congenital Heart Association, in conjunction with the International Society of Adult Congenital Heart Disease, is putting together a directory of self-described adult congenital heart clinics nationwide; so far, they have received 37 surveys from centers that describe themselves as such, according to Ms. Verstappen.

UCLA also has the first and largest training program for the specialty; the program admits one or two fellows per year, depending on the strength of the applicant pool, Dr. Perloff said.

Physicians may apply for the fellowship after they finish residency, which must include 2 years in general cardiology and some pediatric cardiology as well. The fellowship lasts 1 year, “but usually the fellows stay on another year to complete a research study or develop a particular area of interest,” he noted.

Other training programs include those at the University of California, San Francisco, the Mayo Clinic, the University of Iowa, Iowa City, and the University of Pennsylvania, Philadelphia. But more need to be started, Dr. Perloff said.

He noted that currently there are only about 1,200 board-certified pediatric cardiologists, far too few to take care of the estimated 900,000 adults with congenital heart disease nationwide.

In fact, “there are now more adults with congenital heart disease than infants and children,” he said.

One problem with recruiting people into training programs is that for cardiologists, “training is already very long” with 4 years of residency and 2 years of specialty training, Dr. Williams said.

“To sustain this kind of [subspecialty] training, other aspects of training may need to be shortened, maybe by double-counting certain things, or having a loan forgiveness program or something to help them, because if you delay starting practice for 2 more years, the debt burden is so high a lot of them wouldn't be able to afford to do it,” she said.

This situation is not helped by the fact that many adult congenital heart disease patients have trouble getting health insurance. Coverage for these patients under their parents' insurance policies typically stops when they turn 18 or 21.

“How many 19-year-olds working at whatever job someone that age can have, will have health insurance?” Dr. Williams said. Treating uninsured or underinsured patients then adds to the physicians' financial woes.

To bring more attention to the issues surrounding these patients, the Adult Congenital Heart Association and several other organizations sponsored a “lobby day” in Washington on Feb. 8, aimed in part at getting Congress to fund a registry of congenital heart disease patients.

“We need basic data to help us plan for the needs of adults with congenital heart disease. We need to do evidence-based medicine,” Ms. Verstappen said. “We also want to help children with congenital heart disease. Right now, we are doing surgeries in children without the data we could have from adults.”

AACE Defends Patient Release Rule

The American Association of Clinical Endocrinologists is defending a rule by the Nuclear Regulatory Commission that permits outpatient treatment using high doses of radioactive iodine. “We believe that the current rule has improved health care delivery by allowing more timely and convenient treatment of patients with thyroid cancer,” AACE President Bill Law Jr. wrote in a letter to the NRC. “In the past, the majority of patients … were hospitalized for therapy. … Unanticipated competition and conflicts in scheduling [the few beds available] often arose—leading to prolonged profound hypothyroidism in some patients. Outpatient scheduling has provided the flexibility to treat patients at an optimal time of their choosing.” AACE was responding to a petition by Peter G. Crane, a former NRC employee, to revoke the current rule, which allows patients to be released from radioactive isolation with more than the equivalent of 30 millicuries of I-131 in their systems. Mr. Crane, himself a former thyroid cancer patient, argued that letting patients receive outpatient radioactive iodine treatment exposes their families to harmful amounts of radiation. Outpatient therapy “means that patients who are sick, stressed, deeply hypothyroid, potentially nauseous, and highly radioactive are being sent out the door, where they may or may not come into close contact with loved ones and members of the public,” Mr. Crane wrote.

New Thyroid Trials Web Site

The American Thyroid Association has launched a Web site that lists ongoing clinical trials of treatments for thyroid diseases. The association is inviting patients to use the search engine at the site,

www.thyroidtrials.org

Enrollees Happy With Part D

A new survey of Medicare beneficiaries who are receiving Part D drug benefits finds them to be largely satisfied. The survey—conducted 10 weeks into the new coverage—was paid for by America's Health Insurance Plans, and conducted by Ayres, McHenry & Associates Inc., a Republican polling firm. The poll surveyed 408 of the 5.2 million people over age 65 years who have self-enrolled in Part D, and 401 of the 6.5 million “dual eligibles,” who were automatically enrolled because they had Medicaid drug coverage. Of those who self-enrolled, 66% said it had been worth the time and effort to enroll, and four-fifths (84%) said they had no problem signing up. The majority—85%–90% of both groups—said they had no problem using the new benefit. “This is a dramatic departure from the conventional wisdom about this program,” said Whitfield Ayres, a principal in the polling firm. But Ron Pollack, executive director of the advocacy group Families USA, said it was not surprising that beneficiaries who went to the trouble to sign up were happy. Shockingly few have signed up, however, said Mr. Pollack. “America's seniors are clearly voting with their feet,” he said.

Bill Seeks Consent for Off-Label Rx

A new bill in the California assembly would require doctors to get informed consent from their patients before “prescribing, administering, or furnishing” a prescription for off-label use. A failure to adhere to the requirement would be considered a violation of the Medical Practice Act, which means physicians could be charged with a crime. The California Medical Association opposes the legislation. In a statement, the CMA said existing law is enough because physicians can be held liable for not disclosing risks. AB 2856 was introduced by Assemblywoman Loni Hancock (D-Berkeley). It would require physicians to specify that a medication is not approved by the Food and Drug Administration for the use that the doctor is recommending, that the risks are unknown, and that there is not a consensus on the efficacy. A patient could withdraw consent at any time.

Patient/Doctor Decision Making

Decisions about medical treatment should be made by physicians and patients, according to a survey of 1,029 adults for the National Consumers League. More than 90% of respondents agreed that “all medications, both over-the-counter and prescription, offer benefits but also carry some risk of side effects. It should be up to physicians and patients to weigh benefits against the risks and to make decisions that are right for them.” The poll also found that the public strongly supports broader access to treatments—even those carrying additional risks—for chronic diseases such as multiple sclerosis, Parkinson's disease, and Alzheimer's disease. “Everything in life carries risks, but in the case of chronic, debilitating conditions, the greatest risk is a lack of new and improved treatment options,” said Linda Golodner, the league's president.

All Groups at Risk for Poor Care

Although disparities exist in health care, those gaps are small compared with the health care everyone receives and what they should be receiving, according to a report from the RAND Corporation. “Differences exist. But they pale in comparison to the chasm between where we are today and where we should be,” said Dr. Steven M. Asch of the University of California, Los Angeles, the study's lead author. The study assessed preventive services and care for 30 acute and chronic conditions that constitute the leading causes of death and disability. Overall, participants received about 55% of recommended care, despite the fact that the recommendations for the conditions involved were widely known and accepted.

AACE Defends Patient Release Rule

The American Association of Clinical Endocrinologists is defending a rule by the Nuclear Regulatory Commission that permits outpatient treatment using high doses of radioactive iodine. “We believe that the current rule has improved health care delivery by allowing more timely and convenient treatment of patients with thyroid cancer,” AACE President Bill Law Jr. wrote in a letter to the NRC. “In the past, the majority of patients … were hospitalized for therapy. … Unanticipated competition and conflicts in scheduling [the few beds available] often arose—leading to prolonged profound hypothyroidism in some patients. Outpatient scheduling has provided the flexibility to treat patients at an optimal time of their choosing.” AACE was responding to a petition by Peter G. Crane, a former NRC employee, to revoke the current rule, which allows patients to be released from radioactive isolation with more than the equivalent of 30 millicuries of I-131 in their systems. Mr. Crane, himself a former thyroid cancer patient, argued that letting patients receive outpatient radioactive iodine treatment exposes their families to harmful amounts of radiation. Outpatient therapy “means that patients who are sick, stressed, deeply hypothyroid, potentially nauseous, and highly radioactive are being sent out the door, where they may or may not come into close contact with loved ones and members of the public,” Mr. Crane wrote.

New Thyroid Trials Web Site

The American Thyroid Association has launched a Web site that lists ongoing clinical trials of treatments for thyroid diseases. The association is inviting patients to use the search engine at the site,

www.thyroidtrials.org

Enrollees Happy With Part D

A new survey of Medicare beneficiaries who are receiving Part D drug benefits finds them to be largely satisfied. The survey—conducted 10 weeks into the new coverage—was paid for by America's Health Insurance Plans, and conducted by Ayres, McHenry & Associates Inc., a Republican polling firm. The poll surveyed 408 of the 5.2 million people over age 65 years who have self-enrolled in Part D, and 401 of the 6.5 million “dual eligibles,” who were automatically enrolled because they had Medicaid drug coverage. Of those who self-enrolled, 66% said it had been worth the time and effort to enroll, and four-fifths (84%) said they had no problem signing up. The majority—85%–90% of both groups—said they had no problem using the new benefit. “This is a dramatic departure from the conventional wisdom about this program,” said Whitfield Ayres, a principal in the polling firm. But Ron Pollack, executive director of the advocacy group Families USA, said it was not surprising that beneficiaries who went to the trouble to sign up were happy. Shockingly few have signed up, however, said Mr. Pollack. “America's seniors are clearly voting with their feet,” he said.

Bill Seeks Consent for Off-Label Rx

A new bill in the California assembly would require doctors to get informed consent from their patients before “prescribing, administering, or furnishing” a prescription for off-label use. A failure to adhere to the requirement would be considered a violation of the Medical Practice Act, which means physicians could be charged with a crime. The California Medical Association opposes the legislation. In a statement, the CMA said existing law is enough because physicians can be held liable for not disclosing risks. AB 2856 was introduced by Assemblywoman Loni Hancock (D-Berkeley). It would require physicians to specify that a medication is not approved by the Food and Drug Administration for the use that the doctor is recommending, that the risks are unknown, and that there is not a consensus on the efficacy. A patient could withdraw consent at any time.

Patient/Doctor Decision Making

Decisions about medical treatment should be made by physicians and patients, according to a survey of 1,029 adults for the National Consumers League. More than 90% of respondents agreed that “all medications, both over-the-counter and prescription, offer benefits but also carry some risk of side effects. It should be up to physicians and patients to weigh benefits against the risks and to make decisions that are right for them.” The poll also found that the public strongly supports broader access to treatments—even those carrying additional risks—for chronic diseases such as multiple sclerosis, Parkinson's disease, and Alzheimer's disease. “Everything in life carries risks, but in the case of chronic, debilitating conditions, the greatest risk is a lack of new and improved treatment options,” said Linda Golodner, the league's president.

All Groups at Risk for Poor Care

Although disparities exist in health care, those gaps are small compared with the health care everyone receives and what they should be receiving, according to a report from the RAND Corporation. “Differences exist. But they pale in comparison to the chasm between where we are today and where we should be,” said Dr. Steven M. Asch of the University of California, Los Angeles, the study's lead author. The study assessed preventive services and care for 30 acute and chronic conditions that constitute the leading causes of death and disability. Overall, participants received about 55% of recommended care, despite the fact that the recommendations for the conditions involved were widely known and accepted.

AACE Defends Patient Release Rule

The American Association of Clinical Endocrinologists is defending a rule by the Nuclear Regulatory Commission that permits outpatient treatment using high doses of radioactive iodine. “We believe that the current rule has improved health care delivery by allowing more timely and convenient treatment of patients with thyroid cancer,” AACE President Bill Law Jr. wrote in a letter to the NRC. “In the past, the majority of patients … were hospitalized for therapy. … Unanticipated competition and conflicts in scheduling [the few beds available] often arose—leading to prolonged profound hypothyroidism in some patients. Outpatient scheduling has provided the flexibility to treat patients at an optimal time of their choosing.” AACE was responding to a petition by Peter G. Crane, a former NRC employee, to revoke the current rule, which allows patients to be released from radioactive isolation with more than the equivalent of 30 millicuries of I-131 in their systems. Mr. Crane, himself a former thyroid cancer patient, argued that letting patients receive outpatient radioactive iodine treatment exposes their families to harmful amounts of radiation. Outpatient therapy “means that patients who are sick, stressed, deeply hypothyroid, potentially nauseous, and highly radioactive are being sent out the door, where they may or may not come into close contact with loved ones and members of the public,” Mr. Crane wrote.

New Thyroid Trials Web Site

The American Thyroid Association has launched a Web site that lists ongoing clinical trials of treatments for thyroid diseases. The association is inviting patients to use the search engine at the site,

www.thyroidtrials.org

Enrollees Happy With Part D

A new survey of Medicare beneficiaries who are receiving Part D drug benefits finds them to be largely satisfied. The survey—conducted 10 weeks into the new coverage—was paid for by America's Health Insurance Plans, and conducted by Ayres, McHenry & Associates Inc., a Republican polling firm. The poll surveyed 408 of the 5.2 million people over age 65 years who have self-enrolled in Part D, and 401 of the 6.5 million “dual eligibles,” who were automatically enrolled because they had Medicaid drug coverage. Of those who self-enrolled, 66% said it had been worth the time and effort to enroll, and four-fifths (84%) said they had no problem signing up. The majority—85%–90% of both groups—said they had no problem using the new benefit. “This is a dramatic departure from the conventional wisdom about this program,” said Whitfield Ayres, a principal in the polling firm. But Ron Pollack, executive director of the advocacy group Families USA, said it was not surprising that beneficiaries who went to the trouble to sign up were happy. Shockingly few have signed up, however, said Mr. Pollack. “America's seniors are clearly voting with their feet,” he said.

Bill Seeks Consent for Off-Label Rx

A new bill in the California assembly would require doctors to get informed consent from their patients before “prescribing, administering, or furnishing” a prescription for off-label use. A failure to adhere to the requirement would be considered a violation of the Medical Practice Act, which means physicians could be charged with a crime. The California Medical Association opposes the legislation. In a statement, the CMA said existing law is enough because physicians can be held liable for not disclosing risks. AB 2856 was introduced by Assemblywoman Loni Hancock (D-Berkeley). It would require physicians to specify that a medication is not approved by the Food and Drug Administration for the use that the doctor is recommending, that the risks are unknown, and that there is not a consensus on the efficacy. A patient could withdraw consent at any time.

Patient/Doctor Decision Making

Decisions about medical treatment should be made by physicians and patients, according to a survey of 1,029 adults for the National Consumers League. More than 90% of respondents agreed that “all medications, both over-the-counter and prescription, offer benefits but also carry some risk of side effects. It should be up to physicians and patients to weigh benefits against the risks and to make decisions that are right for them.” The poll also found that the public strongly supports broader access to treatments—even those carrying additional risks—for chronic diseases such as multiple sclerosis, Parkinson's disease, and Alzheimer's disease. “Everything in life carries risks, but in the case of chronic, debilitating conditions, the greatest risk is a lack of new and improved treatment options,” said Linda Golodner, the league's president.

All Groups at Risk for Poor Care

Although disparities exist in health care, those gaps are small compared with the health care everyone receives and what they should be receiving, according to a report from the RAND Corporation. “Differences exist. But they pale in comparison to the chasm between where we are today and where we should be,” said Dr. Steven M. Asch of the University of California, Los Angeles, the study's lead author. The study assessed preventive services and care for 30 acute and chronic conditions that constitute the leading causes of death and disability. Overall, participants received about 55% of recommended care, despite the fact that the recommendations for the conditions involved were widely known and accepted.

Neurology in the Media

Newspaper coverage of neurologic illness contained errors or exaggerations 20% of the time, researchers from the Mayo Clinic and Arizona State University found. They examined more than 1,200 newspaper articles from 2003 that dealt with any of 11 common neurologic conditions to see if they contained medical errors or stigmatizing language, said the study published in Mayo Clinic Proceedings. Most inaccuracies revolved around neurodegenerative diseases such as Alzheimer's or Parkinson's disease, and most involved exaggerating symptoms or overstating the treatment effects of new therapies that had been tried only in animal models. The researchers found that 21% of all locally produced stories contained stigmatizing language—defined as “wording that portrays the patient with the neurologic condition as socially undesirable, less desirable, or reduced in personal worth.” They also noted that conditions with the highest prevalence, such as migraine and head trauma, received the least press coverage. “It would be valuable to determine whether such discrepancies mislead individuals about relative risks of particular illnesses or shape public policy about where medical resources are most needed,” Jessica M. Fisherman, Ph.D., and her colleagues said in an accompanying editorial.

New Multisite Imaging Project

NIH's National Center for Research Resources is providing just over $24 million over 5 years to the University of California, Irvine to support the Biomedical Informatics Research Network (BIRN), a consortium of 28 universities and 37 research groups. The university is heading up Function BIRN, an effort by 14 network members to develop and test interdisciplinary techniques for integrating efforts in functional magnetic resonance imaging across multiple sites. “Through this effort, we are creating new models for collaboration among researchers who study diseases at multiple sites with different equipment,” said Dr. Elaine Collier, assistant director of the center's division of clinical research. The knowledge gained “will accelerate scientific discoveries by allowing researchers to tackle complex questions and large-scale research projects that were not previously possible.” More information about the project can be found at

www.ncrr.nih.gov/biotech/btbirn.asp

New Medicare Part D Numbers

The government is on track to achieve its goal of enrolling 28–30 million Medicare beneficiaries in the Part D drug benefit in the first year, the Health and Human Services Department announced. Some 27 million Americans now have prescription drug coverage, said HHS. However, by the end of March, only 6 million had signed up on their own for a stand-alone drug plan since coverage became available in January. Another 6.4 million were automatically enrolled because they were eligible for both Medicare and Medicaid. Close to 6 million already had drug coverage through Medicare Advantage, Medicare's HMO program. The government also counted retirees who receive a drug benefit through their employer or a Medicare retiree subsidy.

Neurology in the Media

Newspaper coverage of neurologic illness contained errors or exaggerations 20% of the time, researchers from the Mayo Clinic and Arizona State University found. They examined more than 1,200 newspaper articles from 2003 that dealt with any of 11 common neurologic conditions to see if they contained medical errors or stigmatizing language, said the study published in Mayo Clinic Proceedings. Most inaccuracies revolved around neurodegenerative diseases such as Alzheimer's or Parkinson's disease, and most involved exaggerating symptoms or overstating the treatment effects of new therapies that had been tried only in animal models. The researchers found that 21% of all locally produced stories contained stigmatizing language—defined as “wording that portrays the patient with the neurologic condition as socially undesirable, less desirable, or reduced in personal worth.” They also noted that conditions with the highest prevalence, such as migraine and head trauma, received the least press coverage. “It would be valuable to determine whether such discrepancies mislead individuals about relative risks of particular illnesses or shape public policy about where medical resources are most needed,” Jessica M. Fisherman, Ph.D., and her colleagues said in an accompanying editorial.

New Multisite Imaging Project

NIH's National Center for Research Resources is providing just over $24 million over 5 years to the University of California, Irvine to support the Biomedical Informatics Research Network (BIRN), a consortium of 28 universities and 37 research groups. The university is heading up Function BIRN, an effort by 14 network members to develop and test interdisciplinary techniques for integrating efforts in functional magnetic resonance imaging across multiple sites. “Through this effort, we are creating new models for collaboration among researchers who study diseases at multiple sites with different equipment,” said Dr. Elaine Collier, assistant director of the center's division of clinical research. The knowledge gained “will accelerate scientific discoveries by allowing researchers to tackle complex questions and large-scale research projects that were not previously possible.” More information about the project can be found at

www.ncrr.nih.gov/biotech/btbirn.asp

New Medicare Part D Numbers

The government is on track to achieve its goal of enrolling 28–30 million Medicare beneficiaries in the Part D drug benefit in the first year, the Health and Human Services Department announced. Some 27 million Americans now have prescription drug coverage, said HHS. However, by the end of March, only 6 million had signed up on their own for a stand-alone drug plan since coverage became available in January. Another 6.4 million were automatically enrolled because they were eligible for both Medicare and Medicaid. Close to 6 million already had drug coverage through Medicare Advantage, Medicare's HMO program. The government also counted retirees who receive a drug benefit through their employer or a Medicare retiree subsidy.

Neurology in the Media

Newspaper coverage of neurologic illness contained errors or exaggerations 20% of the time, researchers from the Mayo Clinic and Arizona State University found. They examined more than 1,200 newspaper articles from 2003 that dealt with any of 11 common neurologic conditions to see if they contained medical errors or stigmatizing language, said the study published in Mayo Clinic Proceedings. Most inaccuracies revolved around neurodegenerative diseases such as Alzheimer's or Parkinson's disease, and most involved exaggerating symptoms or overstating the treatment effects of new therapies that had been tried only in animal models. The researchers found that 21% of all locally produced stories contained stigmatizing language—defined as “wording that portrays the patient with the neurologic condition as socially undesirable, less desirable, or reduced in personal worth.” They also noted that conditions with the highest prevalence, such as migraine and head trauma, received the least press coverage. “It would be valuable to determine whether such discrepancies mislead individuals about relative risks of particular illnesses or shape public policy about where medical resources are most needed,” Jessica M. Fisherman, Ph.D., and her colleagues said in an accompanying editorial.

New Multisite Imaging Project

NIH's National Center for Research Resources is providing just over $24 million over 5 years to the University of California, Irvine to support the Biomedical Informatics Research Network (BIRN), a consortium of 28 universities and 37 research groups. The university is heading up Function BIRN, an effort by 14 network members to develop and test interdisciplinary techniques for integrating efforts in functional magnetic resonance imaging across multiple sites. “Through this effort, we are creating new models for collaboration among researchers who study diseases at multiple sites with different equipment,” said Dr. Elaine Collier, assistant director of the center's division of clinical research. The knowledge gained “will accelerate scientific discoveries by allowing researchers to tackle complex questions and large-scale research projects that were not previously possible.” More information about the project can be found at

www.ncrr.nih.gov/biotech/btbirn.asp

New Medicare Part D Numbers

The government is on track to achieve its goal of enrolling 28–30 million Medicare beneficiaries in the Part D drug benefit in the first year, the Health and Human Services Department announced. Some 27 million Americans now have prescription drug coverage, said HHS. However, by the end of March, only 6 million had signed up on their own for a stand-alone drug plan since coverage became available in January. Another 6.4 million were automatically enrolled because they were eligible for both Medicare and Medicaid. Close to 6 million already had drug coverage through Medicare Advantage, Medicare's HMO program. The government also counted retirees who receive a drug benefit through their employer or a Medicare retiree subsidy.

WASHINGTON — Does your Medicare patient need a prescription for a drug not on his or her drug plan formulary? Be forewarned: You may have to fill out pages of forms.

“There continue to be widespread reports of drug plans requiring prior authorization for beneficiaries to receive needed medication,” Sen. Hillary Rodham Clinton (D-N.Y.) said during a hearing of the U.S. Senate Special Committee on Aging. “Some reports have plans requiring forms for each drug, while others are requiring doctors to fill out forms as long as 14 pages for drugs that a beneficiary has been taking for years.”

Addressing her remarks to Dr. Mark B. McClellan, administrator of the Centers for Medicare and Medicaid Services and the hearing's first witness, Sen. Clinton continued, “Your agency's request that plans discontinue this practice does not seem to be working, based on the information we have. I hope that you will require, not request, that the plans cease this practice and enforce that requirement.”

In his prepared testimony, Dr. McClellan noted that CMS has “developed specific procedures for timely exceptions and appeals. Using those procedures, a Medicare beneficiary can get coverage for a drug that is not on a plan's established formulary.”

He also acknowledged, however, that the plan rollout was not without problems. “We make no excuses for these problems,” he told committee members. “They are important, they are ours to solve, and we are finding and fixing them.”

Many of the problems with getting prescriptions filled occurred in the dual-eligible population—patients who qualified for both Medicare and Medicaid. “These often are the poorest and most vulnerable Americans who rely on medications to manage their chronic physical and mental illnesses,” noted committee chairman Gordon Smith (R-Ore.). “We knew there would be challenges associated with their transition from Medicaid into the new Medicare drug benefit, but it seems that perhaps not enough was done to ensure a seamless transition.”

As a result of the problems with the drug benefit, “pharmacists are not getting paid on time and have to take out loans to pay their bills and keep their doors open,” said committee member Blanche Lincoln (D-Ark.). “These problems could have been avoided.”

Sen. Clinton said the problems were so bad that she was ready to give up. “I for one believe we should scrap this and start over. We are spending hundreds of billions of dollars on an inefficient delivery of a plan that could be done in a much more cost-effective way,” she said.

But Sen. Rick Santorum (R-Pa.) disagreed. “Throwing it out would doom seniors to a situation where they would be getting less care than they are today,” he said. “We should not be flippant about casting out babies with bathwaters. The idea that we're going to once again play politics with prescription drugs … is below the dignity of this committee.”

Committee member Conrad Burns (R-Mont.) also weighed in. “We Americans are in this business that everything has to be instant—tea, coffee, everything that we do, and we're supposed to have a new program put in place and all at once it's perfect,” he said. “I would ask my colleagues [to just] get the program in place; that serves our purpose, and then we know what to fix.”

WASHINGTON — Does your Medicare patient need a prescription for a drug not on his or her drug plan formulary? Be forewarned: You may have to fill out pages of forms.

“There continue to be widespread reports of drug plans requiring prior authorization for beneficiaries to receive needed medication,” Sen. Hillary Rodham Clinton (D-N.Y.) said during a hearing of the U.S. Senate Special Committee on Aging. “Some reports have plans requiring forms for each drug, while others are requiring doctors to fill out forms as long as 14 pages for drugs that a beneficiary has been taking for years.”

Addressing her remarks to Dr. Mark B. McClellan, administrator of the Centers for Medicare and Medicaid Services and the hearing's first witness, Sen. Clinton continued, “Your agency's request that plans discontinue this practice does not seem to be working, based on the information we have. I hope that you will require, not request, that the plans cease this practice and enforce that requirement.”

In his prepared testimony, Dr. McClellan noted that CMS has “developed specific procedures for timely exceptions and appeals. Using those procedures, a Medicare beneficiary can get coverage for a drug that is not on a plan's established formulary.”

He also acknowledged, however, that the plan rollout was not without problems. “We make no excuses for these problems,” he told committee members. “They are important, they are ours to solve, and we are finding and fixing them.”

Many of the problems with getting prescriptions filled occurred in the dual-eligible population—patients who qualified for both Medicare and Medicaid. “These often are the poorest and most vulnerable Americans who rely on medications to manage their chronic physical and mental illnesses,” noted committee chairman Gordon Smith (R-Ore.). “We knew there would be challenges associated with their transition from Medicaid into the new Medicare drug benefit, but it seems that perhaps not enough was done to ensure a seamless transition.”

As a result of the problems with the drug benefit, “pharmacists are not getting paid on time and have to take out loans to pay their bills and keep their doors open,” said committee member Blanche Lincoln (D-Ark.). “These problems could have been avoided.”

Sen. Clinton said the problems were so bad that she was ready to give up. “I for one believe we should scrap this and start over. We are spending hundreds of billions of dollars on an inefficient delivery of a plan that could be done in a much more cost-effective way,” she said.

But Sen. Rick Santorum (R-Pa.) disagreed. “Throwing it out would doom seniors to a situation where they would be getting less care than they are today,” he said. “We should not be flippant about casting out babies with bathwaters. The idea that we're going to once again play politics with prescription drugs … is below the dignity of this committee.”

Committee member Conrad Burns (R-Mont.) also weighed in. “We Americans are in this business that everything has to be instant—tea, coffee, everything that we do, and we're supposed to have a new program put in place and all at once it's perfect,” he said. “I would ask my colleagues [to just] get the program in place; that serves our purpose, and then we know what to fix.”

WASHINGTON — Does your Medicare patient need a prescription for a drug not on his or her drug plan formulary? Be forewarned: You may have to fill out pages of forms.

“There continue to be widespread reports of drug plans requiring prior authorization for beneficiaries to receive needed medication,” Sen. Hillary Rodham Clinton (D-N.Y.) said during a hearing of the U.S. Senate Special Committee on Aging. “Some reports have plans requiring forms for each drug, while others are requiring doctors to fill out forms as long as 14 pages for drugs that a beneficiary has been taking for years.”

Addressing her remarks to Dr. Mark B. McClellan, administrator of the Centers for Medicare and Medicaid Services and the hearing's first witness, Sen. Clinton continued, “Your agency's request that plans discontinue this practice does not seem to be working, based on the information we have. I hope that you will require, not request, that the plans cease this practice and enforce that requirement.”

In his prepared testimony, Dr. McClellan noted that CMS has “developed specific procedures for timely exceptions and appeals. Using those procedures, a Medicare beneficiary can get coverage for a drug that is not on a plan's established formulary.”

He also acknowledged, however, that the plan rollout was not without problems. “We make no excuses for these problems,” he told committee members. “They are important, they are ours to solve, and we are finding and fixing them.”

Many of the problems with getting prescriptions filled occurred in the dual-eligible population—patients who qualified for both Medicare and Medicaid. “These often are the poorest and most vulnerable Americans who rely on medications to manage their chronic physical and mental illnesses,” noted committee chairman Gordon Smith (R-Ore.). “We knew there would be challenges associated with their transition from Medicaid into the new Medicare drug benefit, but it seems that perhaps not enough was done to ensure a seamless transition.”

As a result of the problems with the drug benefit, “pharmacists are not getting paid on time and have to take out loans to pay their bills and keep their doors open,” said committee member Blanche Lincoln (D-Ark.). “These problems could have been avoided.”

Sen. Clinton said the problems were so bad that she was ready to give up. “I for one believe we should scrap this and start over. We are spending hundreds of billions of dollars on an inefficient delivery of a plan that could be done in a much more cost-effective way,” she said.

But Sen. Rick Santorum (R-Pa.) disagreed. “Throwing it out would doom seniors to a situation where they would be getting less care than they are today,” he said. “We should not be flippant about casting out babies with bathwaters. The idea that we're going to once again play politics with prescription drugs … is below the dignity of this committee.”

Committee member Conrad Burns (R-Mont.) also weighed in. “We Americans are in this business that everything has to be instant—tea, coffee, everything that we do, and we're supposed to have a new program put in place and all at once it's perfect,” he said. “I would ask my colleagues [to just] get the program in place; that serves our purpose, and then we know what to fix.”

As President Bush puts health savings accounts higher on his agenda, experts continue to debate whether they are a good idea for solving the problems of the uninsured.

“The more I think about these proposals, the more troubling I find them to be,” Leonard Burman, codirector of the Urban-Brookings Tax Policy Center, said in a teleconference sponsored by the Center on Budget and Policy Priorities (CBPP). “I don't think the idea [that people will be more cost conscious] is really going to play out.”

Health savings accounts (HSAs) are accounts that employees contribute to in order to pay for the first several thousand dollars of their health care costs. The accounts are almost always combined with a high-deductible health insurance plan. Contributions to the HSA are tax free, as is money withdrawn for covered medical expenses. If the money is not used in a particular year, it can accumulate in the account.

The Galen Institute, an organization that supports consumer-driven health care, has a more positive view of HSAs. “HSAs give consumers even more control over their health spending decisions—and provide them an incentive to spend wisely and save for future health care needs,” according to a statement from Galen. Critics argue that sick people are not always in a position to shop around for care; that making consumers more cost conscious won't help lower health care costs because most health care spending is for expenses higher than the amount of the deductible, which is out of the consumers' control; and that HSAs tend to attract mostly healthy people, driving up premiums for sicker individuals who remain in more traditional plans.

President Bush highlighted HSAs in his State of the Union address, vowing to “strengthen health savings accounts—making sure individuals and small business employees can buy insurance with the same advantages that people working for big businesses now get.”

In a more detailed statement, White House officials said that the president “proposes making premiums for HSA-compatible insurance policies deductible from income taxes when [these policies are] purchased by individuals outside of work. In addition, an income tax credit would offset payroll taxes paid on premiums paid for their HSA policies.”

The president is also proposing to allow any spending on out-of-pocket health expenses incurred by HSA enrollees—up to $10,500 per family—to be tax free, not just expenses pertaining to the deductible, as allowed under current law.

Such changes would make HSAs even more tempting to some people, said Jason Furman, senior fellow at the CBPP. “HSAs are already an unprecedentedly favored tax vehicle. This proposal now takes a system already tilted and adds a new tax credit.”

If enacted, these proposals could make HSAs so attractive financially that they could begin to rival 401(k) plans as retirement savings vehicles, Mr. Furman said.

For example, suppose a family in a 25% tax bracket contributed the maximum $10,500 to an HSA that is invested at a 3% interest rate. Under the president's proposal, they would owe a payroll tax of $1,607, but they would also get a tax credit for that amount, so the entire $10,500 would stay in the account. If they contributed the same amount into a 401(k), they would still owe the payroll tax, but would not get a tax credit, so only $8,893 would be deposited into the 401(k) account. As a result, the HSA account would end up with $25,486 in it by 2036, versus $21,587 for the 401(k), Mr. Furman said.

Barry Barnett, a principal in PricewaterhouseCoopers' human resource solutions practice, acknowledged that the proposal would result in substantial tax incentives, but said he did not think that employers were going to get rid of their 401(k) offerings because of it.

Ever since employers have switched to defined contribution retirement plans, “there has been enough noise in the system by employees feeling they've lost the entitlement to a defined benefit plan in retirement,” Mr. Barnett said. “If employers start canceling 401(k) plans and instead offer HSAs, I think there will be a major outcry by employees and Congress or some other body of people saying, 'There's got to be some form of retirement benefit,' especially as the government tries to cut back on Social Security entitlements and Medicare entitlements as the president is talking about.”

As President Bush puts health savings accounts higher on his agenda, experts continue to debate whether they are a good idea for solving the problems of the uninsured.

“The more I think about these proposals, the more troubling I find them to be,” Leonard Burman, codirector of the Urban-Brookings Tax Policy Center, said in a teleconference sponsored by the Center on Budget and Policy Priorities (CBPP). “I don't think the idea [that people will be more cost conscious] is really going to play out.”

Health savings accounts (HSAs) are accounts that employees contribute to in order to pay for the first several thousand dollars of their health care costs. The accounts are almost always combined with a high-deductible health insurance plan. Contributions to the HSA are tax free, as is money withdrawn for covered medical expenses. If the money is not used in a particular year, it can accumulate in the account.

The Galen Institute, an organization that supports consumer-driven health care, has a more positive view of HSAs. “HSAs give consumers even more control over their health spending decisions—and provide them an incentive to spend wisely and save for future health care needs,” according to a statement from Galen. Critics argue that sick people are not always in a position to shop around for care; that making consumers more cost conscious won't help lower health care costs because most health care spending is for expenses higher than the amount of the deductible, which is out of the consumers' control; and that HSAs tend to attract mostly healthy people, driving up premiums for sicker individuals who remain in more traditional plans.

President Bush highlighted HSAs in his State of the Union address, vowing to “strengthen health savings accounts—making sure individuals and small business employees can buy insurance with the same advantages that people working for big businesses now get.”

In a more detailed statement, White House officials said that the president “proposes making premiums for HSA-compatible insurance policies deductible from income taxes when [these policies are] purchased by individuals outside of work. In addition, an income tax credit would offset payroll taxes paid on premiums paid for their HSA policies.”

The president is also proposing to allow any spending on out-of-pocket health expenses incurred by HSA enrollees—up to $10,500 per family—to be tax free, not just expenses pertaining to the deductible, as allowed under current law.

Such changes would make HSAs even more tempting to some people, said Jason Furman, senior fellow at the CBPP. “HSAs are already an unprecedentedly favored tax vehicle. This proposal now takes a system already tilted and adds a new tax credit.”

If enacted, these proposals could make HSAs so attractive financially that they could begin to rival 401(k) plans as retirement savings vehicles, Mr. Furman said.

For example, suppose a family in a 25% tax bracket contributed the maximum $10,500 to an HSA that is invested at a 3% interest rate. Under the president's proposal, they would owe a payroll tax of $1,607, but they would also get a tax credit for that amount, so the entire $10,500 would stay in the account. If they contributed the same amount into a 401(k), they would still owe the payroll tax, but would not get a tax credit, so only $8,893 would be deposited into the 401(k) account. As a result, the HSA account would end up with $25,486 in it by 2036, versus $21,587 for the 401(k), Mr. Furman said.

Barry Barnett, a principal in PricewaterhouseCoopers' human resource solutions practice, acknowledged that the proposal would result in substantial tax incentives, but said he did not think that employers were going to get rid of their 401(k) offerings because of it.

Ever since employers have switched to defined contribution retirement plans, “there has been enough noise in the system by employees feeling they've lost the entitlement to a defined benefit plan in retirement,” Mr. Barnett said. “If employers start canceling 401(k) plans and instead offer HSAs, I think there will be a major outcry by employees and Congress or some other body of people saying, 'There's got to be some form of retirement benefit,' especially as the government tries to cut back on Social Security entitlements and Medicare entitlements as the president is talking about.”

As President Bush puts health savings accounts higher on his agenda, experts continue to debate whether they are a good idea for solving the problems of the uninsured.

“The more I think about these proposals, the more troubling I find them to be,” Leonard Burman, codirector of the Urban-Brookings Tax Policy Center, said in a teleconference sponsored by the Center on Budget and Policy Priorities (CBPP). “I don't think the idea [that people will be more cost conscious] is really going to play out.”

Health savings accounts (HSAs) are accounts that employees contribute to in order to pay for the first several thousand dollars of their health care costs. The accounts are almost always combined with a high-deductible health insurance plan. Contributions to the HSA are tax free, as is money withdrawn for covered medical expenses. If the money is not used in a particular year, it can accumulate in the account.

The Galen Institute, an organization that supports consumer-driven health care, has a more positive view of HSAs. “HSAs give consumers even more control over their health spending decisions—and provide them an incentive to spend wisely and save for future health care needs,” according to a statement from Galen. Critics argue that sick people are not always in a position to shop around for care; that making consumers more cost conscious won't help lower health care costs because most health care spending is for expenses higher than the amount of the deductible, which is out of the consumers' control; and that HSAs tend to attract mostly healthy people, driving up premiums for sicker individuals who remain in more traditional plans.

President Bush highlighted HSAs in his State of the Union address, vowing to “strengthen health savings accounts—making sure individuals and small business employees can buy insurance with the same advantages that people working for big businesses now get.”

In a more detailed statement, White House officials said that the president “proposes making premiums for HSA-compatible insurance policies deductible from income taxes when [these policies are] purchased by individuals outside of work. In addition, an income tax credit would offset payroll taxes paid on premiums paid for their HSA policies.”

The president is also proposing to allow any spending on out-of-pocket health expenses incurred by HSA enrollees—up to $10,500 per family—to be tax free, not just expenses pertaining to the deductible, as allowed under current law.

Such changes would make HSAs even more tempting to some people, said Jason Furman, senior fellow at the CBPP. “HSAs are already an unprecedentedly favored tax vehicle. This proposal now takes a system already tilted and adds a new tax credit.”

If enacted, these proposals could make HSAs so attractive financially that they could begin to rival 401(k) plans as retirement savings vehicles, Mr. Furman said.

For example, suppose a family in a 25% tax bracket contributed the maximum $10,500 to an HSA that is invested at a 3% interest rate. Under the president's proposal, they would owe a payroll tax of $1,607, but they would also get a tax credit for that amount, so the entire $10,500 would stay in the account. If they contributed the same amount into a 401(k), they would still owe the payroll tax, but would not get a tax credit, so only $8,893 would be deposited into the 401(k) account. As a result, the HSA account would end up with $25,486 in it by 2036, versus $21,587 for the 401(k), Mr. Furman said.

Barry Barnett, a principal in PricewaterhouseCoopers' human resource solutions practice, acknowledged that the proposal would result in substantial tax incentives, but said he did not think that employers were going to get rid of their 401(k) offerings because of it.

Ever since employers have switched to defined contribution retirement plans, “there has been enough noise in the system by employees feeling they've lost the entitlement to a defined benefit plan in retirement,” Mr. Barnett said. “If employers start canceling 401(k) plans and instead offer HSAs, I think there will be a major outcry by employees and Congress or some other body of people saying, 'There's got to be some form of retirement benefit,' especially as the government tries to cut back on Social Security entitlements and Medicare entitlements as the president is talking about.”

WASHINGTON — The new system for infusion therapy payments under Medicare shows how difficult it is to base payment on “average” prices, Rep. Nancy Johnson (R-Conn.) said at a conference sponsored by Elsevier Oncology.

“An 'on average' payment system always means some people are below the average, and the question is, are you below average on every drug?” Ms. Johnson said. “Well, then you'd be out of business. I've gotten letters from people who are closing up shop to Medicare patients. That's a very, very serious problem.”

Under the new payment system for infusion therapy, providers have a choice: They can either buy their drugs from vendors that Medicare selects in a competitive bidding process, or they can buy drugs from any vendor and accept Medicare's payment of 106% of the average sales price (ASP).

The ASP is determined by data supplied to Medicare by manufacturers and updated every quarter.

Several audience members complained that 106%—also called ASP plus 6%— was nowhere near enough for them to make any profit on the drugs. “I can't purchase any single drug and make any kind of margin on it,” a woman from Alaska said at the meeting. “We send everybody to the hospital [for treatment]; we cannot treat a single person. There's one drug I lose $400 on every time a patient walks in the door.”

Elsevier Oncology and this newspaper are wholly owned subsidiaries of Elsevier.

Rep. Johnson said there seemed to be “pockets” of the country where too many drugs had such negative margins, “but we can't see any logic yet. Is it certain size practices? Is it certain regions of the country? We need your information, because in the end we want something that pays for drugs in a reasonable and fair process.”

One problem with determining the ASP is that it includes prices received by large-group buyers who get big discounts, as well as others who get 'prompt pay' discounts, Rep. Johnson noted. “Those may be too harsh. That may mean that the little guy who is below the average can't make it.”

A big problem with the payment system for drugs is that it is tied to the sustainable growth rate, a target percentage that Medicare sets each year for allowable growth in the Medicare budget, she said. If spending goes above the target, the budget must be cut the following year to make up for it.

Rep. Johnson is sponsoring H.R. 3617, which would repeal the sustainable growth rate altogether and replace it with a payment increase based on the Medicare Economic Index.

That bill is important because increasing payments to physicians is essential for moving toward a pay for performance system, she said. “You can't move ahead on pay-for-performance when you're going to cut reimbursement.”

Another area of reimbursement concern was Medicare's oncology demonstration program. Last year, the program paid physicians $130 for each chemotherapy infusion visit as long as participating physicians filled out paperwork stating whether they are following practice guidelines with that particular patient.

This year, the oncology demonstration program is paying $23 per evaluation and management visit, explained Dr. Peter Bach, senior advisor to Dr. Mark McClellan, administrator of the Centers for Medicare and Medicaid Services.

The new oncology system “deemphasizes chemotherapy, removes the incentive for infusions over other treatments such as oral chemo, and it … creates a longitudinal record. The payment for each event is $23 rather than $130, but obviously the number of events is far greater,” Dr. Bach said.

WASHINGTON — The new system for infusion therapy payments under Medicare shows how difficult it is to base payment on “average” prices, Rep. Nancy Johnson (R-Conn.) said at a conference sponsored by Elsevier Oncology.

“An 'on average' payment system always means some people are below the average, and the question is, are you below average on every drug?” Ms. Johnson said. “Well, then you'd be out of business. I've gotten letters from people who are closing up shop to Medicare patients. That's a very, very serious problem.”

Under the new payment system for infusion therapy, providers have a choice: They can either buy their drugs from vendors that Medicare selects in a competitive bidding process, or they can buy drugs from any vendor and accept Medicare's payment of 106% of the average sales price (ASP).

The ASP is determined by data supplied to Medicare by manufacturers and updated every quarter.

Several audience members complained that 106%—also called ASP plus 6%— was nowhere near enough for them to make any profit on the drugs. “I can't purchase any single drug and make any kind of margin on it,” a woman from Alaska said at the meeting. “We send everybody to the hospital [for treatment]; we cannot treat a single person. There's one drug I lose $400 on every time a patient walks in the door.”

Elsevier Oncology and this newspaper are wholly owned subsidiaries of Elsevier.

Rep. Johnson said there seemed to be “pockets” of the country where too many drugs had such negative margins, “but we can't see any logic yet. Is it certain size practices? Is it certain regions of the country? We need your information, because in the end we want something that pays for drugs in a reasonable and fair process.”

One problem with determining the ASP is that it includes prices received by large-group buyers who get big discounts, as well as others who get 'prompt pay' discounts, Rep. Johnson noted. “Those may be too harsh. That may mean that the little guy who is below the average can't make it.”

A big problem with the payment system for drugs is that it is tied to the sustainable growth rate, a target percentage that Medicare sets each year for allowable growth in the Medicare budget, she said. If spending goes above the target, the budget must be cut the following year to make up for it.

Rep. Johnson is sponsoring H.R. 3617, which would repeal the sustainable growth rate altogether and replace it with a payment increase based on the Medicare Economic Index.

That bill is important because increasing payments to physicians is essential for moving toward a pay for performance system, she said. “You can't move ahead on pay-for-performance when you're going to cut reimbursement.”

Another area of reimbursement concern was Medicare's oncology demonstration program. Last year, the program paid physicians $130 for each chemotherapy infusion visit as long as participating physicians filled out paperwork stating whether they are following practice guidelines with that particular patient.

This year, the oncology demonstration program is paying $23 per evaluation and management visit, explained Dr. Peter Bach, senior advisor to Dr. Mark McClellan, administrator of the Centers for Medicare and Medicaid Services.

The new oncology system “deemphasizes chemotherapy, removes the incentive for infusions over other treatments such as oral chemo, and it … creates a longitudinal record. The payment for each event is $23 rather than $130, but obviously the number of events is far greater,” Dr. Bach said.

WASHINGTON — The new system for infusion therapy payments under Medicare shows how difficult it is to base payment on “average” prices, Rep. Nancy Johnson (R-Conn.) said at a conference sponsored by Elsevier Oncology.

“An 'on average' payment system always means some people are below the average, and the question is, are you below average on every drug?” Ms. Johnson said. “Well, then you'd be out of business. I've gotten letters from people who are closing up shop to Medicare patients. That's a very, very serious problem.”

Under the new payment system for infusion therapy, providers have a choice: They can either buy their drugs from vendors that Medicare selects in a competitive bidding process, or they can buy drugs from any vendor and accept Medicare's payment of 106% of the average sales price (ASP).

The ASP is determined by data supplied to Medicare by manufacturers and updated every quarter.

Several audience members complained that 106%—also called ASP plus 6%— was nowhere near enough for them to make any profit on the drugs. “I can't purchase any single drug and make any kind of margin on it,” a woman from Alaska said at the meeting. “We send everybody to the hospital [for treatment]; we cannot treat a single person. There's one drug I lose $400 on every time a patient walks in the door.”

Elsevier Oncology and this newspaper are wholly owned subsidiaries of Elsevier.

Rep. Johnson said there seemed to be “pockets” of the country where too many drugs had such negative margins, “but we can't see any logic yet. Is it certain size practices? Is it certain regions of the country? We need your information, because in the end we want something that pays for drugs in a reasonable and fair process.”

One problem with determining the ASP is that it includes prices received by large-group buyers who get big discounts, as well as others who get 'prompt pay' discounts, Rep. Johnson noted. “Those may be too harsh. That may mean that the little guy who is below the average can't make it.”

A big problem with the payment system for drugs is that it is tied to the sustainable growth rate, a target percentage that Medicare sets each year for allowable growth in the Medicare budget, she said. If spending goes above the target, the budget must be cut the following year to make up for it.

Rep. Johnson is sponsoring H.R. 3617, which would repeal the sustainable growth rate altogether and replace it with a payment increase based on the Medicare Economic Index.

That bill is important because increasing payments to physicians is essential for moving toward a pay for performance system, she said. “You can't move ahead on pay-for-performance when you're going to cut reimbursement.”

Another area of reimbursement concern was Medicare's oncology demonstration program. Last year, the program paid physicians $130 for each chemotherapy infusion visit as long as participating physicians filled out paperwork stating whether they are following practice guidelines with that particular patient.

This year, the oncology demonstration program is paying $23 per evaluation and management visit, explained Dr. Peter Bach, senior advisor to Dr. Mark McClellan, administrator of the Centers for Medicare and Medicaid Services.

The new oncology system “deemphasizes chemotherapy, removes the incentive for infusions over other treatments such as oral chemo, and it … creates a longitudinal record. The payment for each event is $23 rather than $130, but obviously the number of events is far greater,” Dr. Bach said.

WASHINGTON — Does your Medicare patient need a prescription for a drug not on his or her drug plan formulary? Be forewarned: You may have to fill out pages of forms.

“There continue to be widespread reports of drug plans requiring prior authorization for beneficiaries to receive needed medication,” Sen. Hillary Rodham Clinton (D-N.Y.) said during a hearing of the U.S. Senate Special Committee on Aging. “Some reports have plans requiring forms for each drug, while others are requiring doctors to fill out forms as long as 14 pages for drugs that a beneficiary has been taking for years.”

Addressing her remarks to Dr. Mark B. McClellan, administrator of the Centers for Medicare and Medicaid Services and the hearing's first witness, Sen. Clinton continued, “Your agency's request that plans discontinue this practice does not seem to be working. … I hope that you will require, not request, require that the plans cease this practice and enforce that requirement.”

In his prepared testimony, Dr. McClellan noted that CMS has “developed specific procedures for timely exceptions and appeals. Using those procedures, a Medicare beneficiary can get coverage for a drug that is not on a plan's established formulary.”

He also acknowledged, however, that the plan rollout was not without problems. “We make no excuses for these problems,” he said “They are important, they are ours to solve, and we are finding and fixing them.”

Many of the problems with getting prescriptions filled occurred in the dual-eligible population—patients who qualified for both Medicare and Medicaid. “These often are the poorest and most vulnerable Americans who rely on medications to manage their chronic physical and mental illnesses,” noted committee chairman Gordon Smith (R-Ore.) “We knew there would be challenges associated with their transition from Medicaid into the new Medicare drug benefit, but it seems that perhaps not enough was done to ensure a seamless transition.”

As a result of the problems with the drug benefit, “pharmacists are not getting paid on time and have to take out loans to pay their bills and keep their doors open,” said committee member Blanche Lincoln (D-Ark.). “These problems could have been avoided.”

Sen. Clinton said the problems were so bad that she was ready to give up. “I for one believe we should scrap this and start over. We are spending hundreds of billions of dollars on an inefficient delivery of a plan that could be done in a much more cost-effective way,” she said.

But Sen. Rick Santorum (R-Pa.) disagreed. “Throwing it out would doom seniors to a situation where they would be getting less care than they are today.”

Committee member Conrad Burns (R-Mont.) also weighed in. “We Americans are in this business that everything has to be instant—tea, coffee, everything that we do, and we're supposed to have a new program put in place and all at once it's perfect,” he said. “I would ask my colleagues [to just] get the program in place; that serves our purpose, and then we know what to fix. Right now, we don't know what to fix.”

One thing Sen. Smith said that he wants to fix is the part of the program that requires dual-eligible patients living at home or in an assisted living facility to pay copayments for drugs received under the program; currently, only dual-eligible patients in nursing homes are exempt from copayments. Sen. Smith introduced a bill eliminating the copayments for dual-eligible patients in home- or community-based care; the measure, which was cosponsored by Sen. Jeff Bingaman (D-N.M.) was still being considered at press time.

WASHINGTON — Does your Medicare patient need a prescription for a drug not on his or her drug plan formulary? Be forewarned: You may have to fill out pages of forms.

“There continue to be widespread reports of drug plans requiring prior authorization for beneficiaries to receive needed medication,” Sen. Hillary Rodham Clinton (D-N.Y.) said during a hearing of the U.S. Senate Special Committee on Aging. “Some reports have plans requiring forms for each drug, while others are requiring doctors to fill out forms as long as 14 pages for drugs that a beneficiary has been taking for years.”

Addressing her remarks to Dr. Mark B. McClellan, administrator of the Centers for Medicare and Medicaid Services and the hearing's first witness, Sen. Clinton continued, “Your agency's request that plans discontinue this practice does not seem to be working. … I hope that you will require, not request, require that the plans cease this practice and enforce that requirement.”

In his prepared testimony, Dr. McClellan noted that CMS has “developed specific procedures for timely exceptions and appeals. Using those procedures, a Medicare beneficiary can get coverage for a drug that is not on a plan's established formulary.”

He also acknowledged, however, that the plan rollout was not without problems. “We make no excuses for these problems,” he said “They are important, they are ours to solve, and we are finding and fixing them.”

Many of the problems with getting prescriptions filled occurred in the dual-eligible population—patients who qualified for both Medicare and Medicaid. “These often are the poorest and most vulnerable Americans who rely on medications to manage their chronic physical and mental illnesses,” noted committee chairman Gordon Smith (R-Ore.) “We knew there would be challenges associated with their transition from Medicaid into the new Medicare drug benefit, but it seems that perhaps not enough was done to ensure a seamless transition.”

As a result of the problems with the drug benefit, “pharmacists are not getting paid on time and have to take out loans to pay their bills and keep their doors open,” said committee member Blanche Lincoln (D-Ark.). “These problems could have been avoided.”

Sen. Clinton said the problems were so bad that she was ready to give up. “I for one believe we should scrap this and start over. We are spending hundreds of billions of dollars on an inefficient delivery of a plan that could be done in a much more cost-effective way,” she said.

But Sen. Rick Santorum (R-Pa.) disagreed. “Throwing it out would doom seniors to a situation where they would be getting less care than they are today.”

Committee member Conrad Burns (R-Mont.) also weighed in. “We Americans are in this business that everything has to be instant—tea, coffee, everything that we do, and we're supposed to have a new program put in place and all at once it's perfect,” he said. “I would ask my colleagues [to just] get the program in place; that serves our purpose, and then we know what to fix. Right now, we don't know what to fix.”

One thing Sen. Smith said that he wants to fix is the part of the program that requires dual-eligible patients living at home or in an assisted living facility to pay copayments for drugs received under the program; currently, only dual-eligible patients in nursing homes are exempt from copayments. Sen. Smith introduced a bill eliminating the copayments for dual-eligible patients in home- or community-based care; the measure, which was cosponsored by Sen. Jeff Bingaman (D-N.M.) was still being considered at press time.

WASHINGTON — Does your Medicare patient need a prescription for a drug not on his or her drug plan formulary? Be forewarned: You may have to fill out pages of forms.

“There continue to be widespread reports of drug plans requiring prior authorization for beneficiaries to receive needed medication,” Sen. Hillary Rodham Clinton (D-N.Y.) said during a hearing of the U.S. Senate Special Committee on Aging. “Some reports have plans requiring forms for each drug, while others are requiring doctors to fill out forms as long as 14 pages for drugs that a beneficiary has been taking for years.”

Addressing her remarks to Dr. Mark B. McClellan, administrator of the Centers for Medicare and Medicaid Services and the hearing's first witness, Sen. Clinton continued, “Your agency's request that plans discontinue this practice does not seem to be working. … I hope that you will require, not request, require that the plans cease this practice and enforce that requirement.”

In his prepared testimony, Dr. McClellan noted that CMS has “developed specific procedures for timely exceptions and appeals. Using those procedures, a Medicare beneficiary can get coverage for a drug that is not on a plan's established formulary.”

He also acknowledged, however, that the plan rollout was not without problems. “We make no excuses for these problems,” he said “They are important, they are ours to solve, and we are finding and fixing them.”

Many of the problems with getting prescriptions filled occurred in the dual-eligible population—patients who qualified for both Medicare and Medicaid. “These often are the poorest and most vulnerable Americans who rely on medications to manage their chronic physical and mental illnesses,” noted committee chairman Gordon Smith (R-Ore.) “We knew there would be challenges associated with their transition from Medicaid into the new Medicare drug benefit, but it seems that perhaps not enough was done to ensure a seamless transition.”

As a result of the problems with the drug benefit, “pharmacists are not getting paid on time and have to take out loans to pay their bills and keep their doors open,” said committee member Blanche Lincoln (D-Ark.). “These problems could have been avoided.”

Sen. Clinton said the problems were so bad that she was ready to give up. “I for one believe we should scrap this and start over. We are spending hundreds of billions of dollars on an inefficient delivery of a plan that could be done in a much more cost-effective way,” she said.

But Sen. Rick Santorum (R-Pa.) disagreed. “Throwing it out would doom seniors to a situation where they would be getting less care than they are today.”

Committee member Conrad Burns (R-Mont.) also weighed in. “We Americans are in this business that everything has to be instant—tea, coffee, everything that we do, and we're supposed to have a new program put in place and all at once it's perfect,” he said. “I would ask my colleagues [to just] get the program in place; that serves our purpose, and then we know what to fix. Right now, we don't know what to fix.”

One thing Sen. Smith said that he wants to fix is the part of the program that requires dual-eligible patients living at home or in an assisted living facility to pay copayments for drugs received under the program; currently, only dual-eligible patients in nursing homes are exempt from copayments. Sen. Smith introduced a bill eliminating the copayments for dual-eligible patients in home- or community-based care; the measure, which was cosponsored by Sen. Jeff Bingaman (D-N.M.) was still being considered at press time.

Obesity Prevalent in Medicaid Kids

Children on Medicaid are six times more likely to be treated for obesity than children with private insurance are, according to a study from Thomson Medstat, a consulting/research firm based in Ann Arbor, Mich. The study looked at 2004 data from eight state Medicaid programs that represented 1 million children. The information was compared with records from 62 large insurers that insured another 1.9 million children. The study found that 195 of every 100,000 privately insured children were treated for obesity, compared with 1,115 per 100,000 for Medicaid children. Researchers speculated that the nearly sixfold difference “underestimates the differential in untreated obesity,” given the difficulties that children covered by Medicaid have with accessing the health care system. Dr. William Cochran, a pediatric gastroenterologist at Geisinger Health System in Danville, Pa., said that the findings were “interesting, but I do not think that this is of any tremendous significance.” It's already known that pediatric obesity is being underdiagnosed and undertreated by health care providers. Because obesity is not a diagnosis covered by most insurance companies, many providers do not code it, he said. Although lower socioeconomic status may factor in as a risk, along with obese parents and minority status, “obesity is very prevalent throughout our society at all socioeconomic levels. With 15% of children being overweight and 15% being obese, all children should be considered at risk,” he said.

AAP, Microsoft Seek Internet Controls

The American Academy of Pediatrics is working with Microsoft to develop a new line of parental controls for the Internet. The free program, called Family Safety Settings, will be part of Microsoft's Windows Live platform and will start rolling out early this summer. The program will allow families to customize controls for each family member. When children go online, “the No. 1 threat is predators,” Dr. Donald Shifrin, chair of the AAP's Committee on Communications, said in an interview on the AAP Web site. “Beyond that, we also know they can become immersed in online gaming, gambling, and cyberbullying on blog sites. There also are sites on obesity, alcohol, tobacco, and body image that can pose potential problems.” Ryan Hamlin, general manager of Microsoft's technology care and safety group, noted that one feature in the program will warn users before they enter a site that has been deemed inappropriate and will log the activity if the user chooses to proceed to the site—“a tool to help parents understand how their children may be using the Internet.”

Medicaid Prodded on Mental Health

Congress should not give Medicaid too much flexibility when it comes to providing services for children with emotional and substance use disorders, according to a new report from the National Association of Psychiatric Health Systems and the National Association for Children's Behavioral Health. These children “are one of the most at-risk populations served by the Medicaid program—and one of the populations that can benefit most from early and appropriate behavioral health care interventions,” the associations said in the report, titled “Medicaid: Principles for Treatment of Children and Youth With Emotional and Substance Use Disorders.” “Without Medicaid, there is no access to or coverage of mental health care for many of our country's most vulnerable—and treatable—children and youth.” In a separate statement, the two groups urged Congress and the states to reject proposed cuts in the federal government's 2007 Medicaid budget that would affect the program's mental health budget, including the Early and Periodic Screening, Diagnosis, and Treatment program; targeted case management; rehabilitation and clinic options for treatment; and the “under 21” psychiatric benefit.

Docs' Drug-Test Methods Miss Mark

Pediatricians and other primary care physicians often don't use the right urine sampling techniques and validation procedures when they perform drug tests on adolescent patients. Dr. Sharon Levy of Harvard Medical School and her colleagues surveyed 359 physician members of the American Academy of Pediatrics, Society of Adolescent Medicine, and American Academy of Family Physicians and found that only 23% of physician respondents used an effective collection procedure (patient provides identification, empties pockets, and uses the bathroom without running water; blue dye is placed in standing water; and specimen temperature is checked immediately). Only 7% of respondents said they routinely checked both urine creatinine level and specific gravity to prevent patients from cheating on a test by providing diluted urine (Arch. Pediatr. Adolesc. Med. 2006;160:146–50).

Obesity Prevalent in Medicaid Kids

Children on Medicaid are six times more likely to be treated for obesity than children with private insurance are, according to a study from Thomson Medstat, a consulting/research firm based in Ann Arbor, Mich. The study looked at 2004 data from eight state Medicaid programs that represented 1 million children. The information was compared with records from 62 large insurers that insured another 1.9 million children. The study found that 195 of every 100,000 privately insured children were treated for obesity, compared with 1,115 per 100,000 for Medicaid children. Researchers speculated that the nearly sixfold difference “underestimates the differential in untreated obesity,” given the difficulties that children covered by Medicaid have with accessing the health care system. Dr. William Cochran, a pediatric gastroenterologist at Geisinger Health System in Danville, Pa., said that the findings were “interesting, but I do not think that this is of any tremendous significance.” It's already known that pediatric obesity is being underdiagnosed and undertreated by health care providers. Because obesity is not a diagnosis covered by most insurance companies, many providers do not code it, he said. Although lower socioeconomic status may factor in as a risk, along with obese parents and minority status, “obesity is very prevalent throughout our society at all socioeconomic levels. With 15% of children being overweight and 15% being obese, all children should be considered at risk,” he said.

AAP, Microsoft Seek Internet Controls

The American Academy of Pediatrics is working with Microsoft to develop a new line of parental controls for the Internet. The free program, called Family Safety Settings, will be part of Microsoft's Windows Live platform and will start rolling out early this summer. The program will allow families to customize controls for each family member. When children go online, “the No. 1 threat is predators,” Dr. Donald Shifrin, chair of the AAP's Committee on Communications, said in an interview on the AAP Web site. “Beyond that, we also know they can become immersed in online gaming, gambling, and cyberbullying on blog sites. There also are sites on obesity, alcohol, tobacco, and body image that can pose potential problems.” Ryan Hamlin, general manager of Microsoft's technology care and safety group, noted that one feature in the program will warn users before they enter a site that has been deemed inappropriate and will log the activity if the user chooses to proceed to the site—“a tool to help parents understand how their children may be using the Internet.”

Medicaid Prodded on Mental Health

Congress should not give Medicaid too much flexibility when it comes to providing services for children with emotional and substance use disorders, according to a new report from the National Association of Psychiatric Health Systems and the National Association for Children's Behavioral Health. These children “are one of the most at-risk populations served by the Medicaid program—and one of the populations that can benefit most from early and appropriate behavioral health care interventions,” the associations said in the report, titled “Medicaid: Principles for Treatment of Children and Youth With Emotional and Substance Use Disorders.” “Without Medicaid, there is no access to or coverage of mental health care for many of our country's most vulnerable—and treatable—children and youth.” In a separate statement, the two groups urged Congress and the states to reject proposed cuts in the federal government's 2007 Medicaid budget that would affect the program's mental health budget, including the Early and Periodic Screening, Diagnosis, and Treatment program; targeted case management; rehabilitation and clinic options for treatment; and the “under 21” psychiatric benefit.

Docs' Drug-Test Methods Miss Mark

Pediatricians and other primary care physicians often don't use the right urine sampling techniques and validation procedures when they perform drug tests on adolescent patients. Dr. Sharon Levy of Harvard Medical School and her colleagues surveyed 359 physician members of the American Academy of Pediatrics, Society of Adolescent Medicine, and American Academy of Family Physicians and found that only 23% of physician respondents used an effective collection procedure (patient provides identification, empties pockets, and uses the bathroom without running water; blue dye is placed in standing water; and specimen temperature is checked immediately). Only 7% of respondents said they routinely checked both urine creatinine level and specific gravity to prevent patients from cheating on a test by providing diluted urine (Arch. Pediatr. Adolesc. Med. 2006;160:146–50).

Obesity Prevalent in Medicaid Kids

Children on Medicaid are six times more likely to be treated for obesity than children with private insurance are, according to a study from Thomson Medstat, a consulting/research firm based in Ann Arbor, Mich. The study looked at 2004 data from eight state Medicaid programs that represented 1 million children. The information was compared with records from 62 large insurers that insured another 1.9 million children. The study found that 195 of every 100,000 privately insured children were treated for obesity, compared with 1,115 per 100,000 for Medicaid children. Researchers speculated that the nearly sixfold difference “underestimates the differential in untreated obesity,” given the difficulties that children covered by Medicaid have with accessing the health care system. Dr. William Cochran, a pediatric gastroenterologist at Geisinger Health System in Danville, Pa., said that the findings were “interesting, but I do not think that this is of any tremendous significance.” It's already known that pediatric obesity is being underdiagnosed and undertreated by health care providers. Because obesity is not a diagnosis covered by most insurance companies, many providers do not code it, he said. Although lower socioeconomic status may factor in as a risk, along with obese parents and minority status, “obesity is very prevalent throughout our society at all socioeconomic levels. With 15% of children being overweight and 15% being obese, all children should be considered at risk,” he said.

AAP, Microsoft Seek Internet Controls

The American Academy of Pediatrics is working with Microsoft to develop a new line of parental controls for the Internet. The free program, called Family Safety Settings, will be part of Microsoft's Windows Live platform and will start rolling out early this summer. The program will allow families to customize controls for each family member. When children go online, “the No. 1 threat is predators,” Dr. Donald Shifrin, chair of the AAP's Committee on Communications, said in an interview on the AAP Web site. “Beyond that, we also know they can become immersed in online gaming, gambling, and cyberbullying on blog sites. There also are sites on obesity, alcohol, tobacco, and body image that can pose potential problems.” Ryan Hamlin, general manager of Microsoft's technology care and safety group, noted that one feature in the program will warn users before they enter a site that has been deemed inappropriate and will log the activity if the user chooses to proceed to the site—“a tool to help parents understand how their children may be using the Internet.”

Medicaid Prodded on Mental Health

Congress should not give Medicaid too much flexibility when it comes to providing services for children with emotional and substance use disorders, according to a new report from the National Association of Psychiatric Health Systems and the National Association for Children's Behavioral Health. These children “are one of the most at-risk populations served by the Medicaid program—and one of the populations that can benefit most from early and appropriate behavioral health care interventions,” the associations said in the report, titled “Medicaid: Principles for Treatment of Children and Youth With Emotional and Substance Use Disorders.” “Without Medicaid, there is no access to or coverage of mental health care for many of our country's most vulnerable—and treatable—children and youth.” In a separate statement, the two groups urged Congress and the states to reject proposed cuts in the federal government's 2007 Medicaid budget that would affect the program's mental health budget, including the Early and Periodic Screening, Diagnosis, and Treatment program; targeted case management; rehabilitation and clinic options for treatment; and the “under 21” psychiatric benefit.

Docs' Drug-Test Methods Miss Mark

Pediatricians and other primary care physicians often don't use the right urine sampling techniques and validation procedures when they perform drug tests on adolescent patients. Dr. Sharon Levy of Harvard Medical School and her colleagues surveyed 359 physician members of the American Academy of Pediatrics, Society of Adolescent Medicine, and American Academy of Family Physicians and found that only 23% of physician respondents used an effective collection procedure (patient provides identification, empties pockets, and uses the bathroom without running water; blue dye is placed in standing water; and specimen temperature is checked immediately). Only 7% of respondents said they routinely checked both urine creatinine level and specific gravity to prevent patients from cheating on a test by providing diluted urine (Arch. Pediatr. Adolesc. Med. 2006;160:146–50).

Smoking Rates Drop

The number of cigarettes sold in the U.S. in 2005 dropped 4.2% from 2004, the largest 1-year percentage decrease in sales since 1999, figures compiled by the Treasury Department show. “We are pleased to see that the long decline of cigarette consumption is continuing,” Cheryl Healton, Dr.P.H., president of the American Legacy Foundation, said in a statement. “We also know that for the first time in the United States, there are more former smokers than current smokers.” The National Association of Attorneys General also applauded the numbers, noting that the drop continues “the unprecedented long-term decline in cigarette smoking that began with the settlement of lawsuits” brought by state attorneys general against the major tobacco companies.

Veterans' PTSD Treatment Urged

Treatment of Iraq War veterans for posttraumatic stress disorder should be a high priority for the Department of Veterans Affairs, according to a bipartisan group of senators. The group wrote a letter to Veterans Affairs Secretary James Nicholson, calling on the department to report on its ability to handle an increasing number of returning veterans suffering from PTSD. The senators referred to 24 recommendations that the VA's own Special Committee on PTSD developed to improve services and treatment for veterans suffering from the illness. The senators want a report no later than May 3 detailing the agency's progress in implementing the recommendations. “It must be a priority to diagnose and treat veterans who suffer from the psychological traumas of war and help them lead healthy, productive lives,” Sen. Elizabeth Dole (R-N.C.), one of the signers, said in a statement. Other signers included Illinois Democratic senators Barack Obama and Dick Durbin, Sen. Tim Johnson (D-S.D.), and Maine Republican senators Olympia Snowe and Susan Collins.

Depression Stats Exaggerated?

Reports suggesting that almost half the U.S. population suffers from depression are “greatly exaggerated,” according to a study appearing in the winter 2006 issue of Contexts magazine, published by the American Sociological Association. Authors Allan V. Horwitz, Ph.D., of Rutgers University and Jerome Wakefield, Ph.D., of New York University argue that community studies reporting high rates of mental illness rely on standard, closed-format questions about symptoms with no context provided to differentiate between reactions to normal life stressors such as a death or a romantic breakup, and pathological conditions that indicate clinical mental illness. “These numbers are largely a product of survey methodologies that, by nature, overstate the number of people with mental illness,” the authors wrote. “Moreover, because people experiencing normal reactions to stressful events are less likely than the truly disordered to seek medical attention, such questions are bound to inflate estimates of the rate of untreated disorder.” The authors say these high numbers continue to be perpetuated for several reasons, including attempts to garner political support for the National Institute of Mental Health and other agencies devoted to preventing and treating these conditions, efforts by pharmaceutical companies to broaden their markets, and work by advocacy groups to use the numbers to lower the social distance between those with mental illness and those without.

Bill Seeks Consent for Off-Label Rx

A bill in the California assembly would require physicians and surgeons to get informed consent from their patients before “prescribing, administering, or furnishing” a prescription for off-label use. A failure to adhere to the requirement would be considered a violation of the Medical Practice Act, which means physicians could be charged with a crime. For dermatologists, the requirements “would bring many a practice to a snail's pace,” said John R. Valencia, a lobbyist for the California Society of Dermatology and Dermatologic Surgery. Karmi A. Ferguson, executive director of the organization, said the legislation “is on our hot list.” If passed, the bill would not reach the governor's desk until September, but “we're hoping to kill it in committee,” Ms. Ferguson said. AB 2856 was introduced by Assemblywoman Loni Hancock (D-Berkeley). It would require physicians to specify that the medication is not approved by the Food and Drug Administration for the use that the doctor is recommending, that the risks are unknown, and that there is not a consensus on the efficacy. A patient could withdraw consent at any time.

Patient/Doctor Decision Making

Decisions about medical treatment should be made by physicians and patients, according to a survey of 1,029 adults for the National Consumers League. More than 90% of respondents agreed that, “All medications, both over-the-counter and prescription, offer benefits but also carry some risk of side effects. It should be up to physicians and patients to weigh benefits against the risks and to make decisions that are right for them,” the survey said. The poll also found that the public strongly supports broader access to treatments for chronic diseases such as multiple sclerosis, Parkinson's disease, and Alzheimer's disease. “Everything in life carries risks, but in the case of chronic, debilitating conditions, the greatest risk is a lack of new and improved treatment options,” said Linda Golodner, the league's president. “It obviously makes sense for these patients to have access to as many treatment options as possible and make decisions that are right for them, even if there are additional risks.”

Smoking Rates Drop

The number of cigarettes sold in the U.S. in 2005 dropped 4.2% from 2004, the largest 1-year percentage decrease in sales since 1999, figures compiled by the Treasury Department show. “We are pleased to see that the long decline of cigarette consumption is continuing,” Cheryl Healton, Dr.P.H., president of the American Legacy Foundation, said in a statement. “We also know that for the first time in the United States, there are more former smokers than current smokers.” The National Association of Attorneys General also applauded the numbers, noting that the drop continues “the unprecedented long-term decline in cigarette smoking that began with the settlement of lawsuits” brought by state attorneys general against the major tobacco companies.

Veterans' PTSD Treatment Urged

Treatment of Iraq War veterans for posttraumatic stress disorder should be a high priority for the Department of Veterans Affairs, according to a bipartisan group of senators. The group wrote a letter to Veterans Affairs Secretary James Nicholson, calling on the department to report on its ability to handle an increasing number of returning veterans suffering from PTSD. The senators referred to 24 recommendations that the VA's own Special Committee on PTSD developed to improve services and treatment for veterans suffering from the illness. The senators want a report no later than May 3 detailing the agency's progress in implementing the recommendations. “It must be a priority to diagnose and treat veterans who suffer from the psychological traumas of war and help them lead healthy, productive lives,” Sen. Elizabeth Dole (R-N.C.), one of the signers, said in a statement. Other signers included Illinois Democratic senators Barack Obama and Dick Durbin, Sen. Tim Johnson (D-S.D.), and Maine Republican senators Olympia Snowe and Susan Collins.

Depression Stats Exaggerated?

Reports suggesting that almost half the U.S. population suffers from depression are “greatly exaggerated,” according to a study appearing in the winter 2006 issue of Contexts magazine, published by the American Sociological Association. Authors Allan V. Horwitz, Ph.D., of Rutgers University and Jerome Wakefield, Ph.D., of New York University argue that community studies reporting high rates of mental illness rely on standard, closed-format questions about symptoms with no context provided to differentiate between reactions to normal life stressors such as a death or a romantic breakup, and pathological conditions that indicate clinical mental illness. “These numbers are largely a product of survey methodologies that, by nature, overstate the number of people with mental illness,” the authors wrote. “Moreover, because people experiencing normal reactions to stressful events are less likely than the truly disordered to seek medical attention, such questions are bound to inflate estimates of the rate of untreated disorder.” The authors say these high numbers continue to be perpetuated for several reasons, including attempts to garner political support for the National Institute of Mental Health and other agencies devoted to preventing and treating these conditions, efforts by pharmaceutical companies to broaden their markets, and work by advocacy groups to use the numbers to lower the social distance between those with mental illness and those without.

Bill Seeks Consent for Off-Label Rx

A bill in the California assembly would require physicians and surgeons to get informed consent from their patients before “prescribing, administering, or furnishing” a prescription for off-label use. A failure to adhere to the requirement would be considered a violation of the Medical Practice Act, which means physicians could be charged with a crime. For dermatologists, the requirements “would bring many a practice to a snail's pace,” said John R. Valencia, a lobbyist for the California Society of Dermatology and Dermatologic Surgery. Karmi A. Ferguson, executive director of the organization, said the legislation “is on our hot list.” If passed, the bill would not reach the governor's desk until September, but “we're hoping to kill it in committee,” Ms. Ferguson said. AB 2856 was introduced by Assemblywoman Loni Hancock (D-Berkeley). It would require physicians to specify that the medication is not approved by the Food and Drug Administration for the use that the doctor is recommending, that the risks are unknown, and that there is not a consensus on the efficacy. A patient could withdraw consent at any time.

Patient/Doctor Decision Making

Decisions about medical treatment should be made by physicians and patients, according to a survey of 1,029 adults for the National Consumers League. More than 90% of respondents agreed that, “All medications, both over-the-counter and prescription, offer benefits but also carry some risk of side effects. It should be up to physicians and patients to weigh benefits against the risks and to make decisions that are right for them,” the survey said. The poll also found that the public strongly supports broader access to treatments for chronic diseases such as multiple sclerosis, Parkinson's disease, and Alzheimer's disease. “Everything in life carries risks, but in the case of chronic, debilitating conditions, the greatest risk is a lack of new and improved treatment options,” said Linda Golodner, the league's president. “It obviously makes sense for these patients to have access to as many treatment options as possible and make decisions that are right for them, even if there are additional risks.”

Smoking Rates Drop

The number of cigarettes sold in the U.S. in 2005 dropped 4.2% from 2004, the largest 1-year percentage decrease in sales since 1999, figures compiled by the Treasury Department show. “We are pleased to see that the long decline of cigarette consumption is continuing,” Cheryl Healton, Dr.P.H., president of the American Legacy Foundation, said in a statement. “We also know that for the first time in the United States, there are more former smokers than current smokers.” The National Association of Attorneys General also applauded the numbers, noting that the drop continues “the unprecedented long-term decline in cigarette smoking that began with the settlement of lawsuits” brought by state attorneys general against the major tobacco companies.

Veterans' PTSD Treatment Urged

Treatment of Iraq War veterans for posttraumatic stress disorder should be a high priority for the Department of Veterans Affairs, according to a bipartisan group of senators. The group wrote a letter to Veterans Affairs Secretary James Nicholson, calling on the department to report on its ability to handle an increasing number of returning veterans suffering from PTSD. The senators referred to 24 recommendations that the VA's own Special Committee on PTSD developed to improve services and treatment for veterans suffering from the illness. The senators want a report no later than May 3 detailing the agency's progress in implementing the recommendations. “It must be a priority to diagnose and treat veterans who suffer from the psychological traumas of war and help them lead healthy, productive lives,” Sen. Elizabeth Dole (R-N.C.), one of the signers, said in a statement. Other signers included Illinois Democratic senators Barack Obama and Dick Durbin, Sen. Tim Johnson (D-S.D.), and Maine Republican senators Olympia Snowe and Susan Collins.

Depression Stats Exaggerated?

Reports suggesting that almost half the U.S. population suffers from depression are “greatly exaggerated,” according to a study appearing in the winter 2006 issue of Contexts magazine, published by the American Sociological Association. Authors Allan V. Horwitz, Ph.D., of Rutgers University and Jerome Wakefield, Ph.D., of New York University argue that community studies reporting high rates of mental illness rely on standard, closed-format questions about symptoms with no context provided to differentiate between reactions to normal life stressors such as a death or a romantic breakup, and pathological conditions that indicate clinical mental illness. “These numbers are largely a product of survey methodologies that, by nature, overstate the number of people with mental illness,” the authors wrote. “Moreover, because people experiencing normal reactions to stressful events are less likely than the truly disordered to seek medical attention, such questions are bound to inflate estimates of the rate of untreated disorder.” The authors say these high numbers continue to be perpetuated for several reasons, including attempts to garner political support for the National Institute of Mental Health and other agencies devoted to preventing and treating these conditions, efforts by pharmaceutical companies to broaden their markets, and work by advocacy groups to use the numbers to lower the social distance between those with mental illness and those without.

Bill Seeks Consent for Off-Label Rx

A bill in the California assembly would require physicians and surgeons to get informed consent from their patients before “prescribing, administering, or furnishing” a prescription for off-label use. A failure to adhere to the requirement would be considered a violation of the Medical Practice Act, which means physicians could be charged with a crime. For dermatologists, the requirements “would bring many a practice to a snail's pace,” said John R. Valencia, a lobbyist for the California Society of Dermatology and Dermatologic Surgery. Karmi A. Ferguson, executive director of the organization, said the legislation “is on our hot list.” If passed, the bill would not reach the governor's desk until September, but “we're hoping to kill it in committee,” Ms. Ferguson said. AB 2856 was introduced by Assemblywoman Loni Hancock (D-Berkeley). It would require physicians to specify that the medication is not approved by the Food and Drug Administration for the use that the doctor is recommending, that the risks are unknown, and that there is not a consensus on the efficacy. A patient could withdraw consent at any time.

Patient/Doctor Decision Making

Decisions about medical treatment should be made by physicians and patients, according to a survey of 1,029 adults for the National Consumers League. More than 90% of respondents agreed that, “All medications, both over-the-counter and prescription, offer benefits but also carry some risk of side effects. It should be up to physicians and patients to weigh benefits against the risks and to make decisions that are right for them,” the survey said. The poll also found that the public strongly supports broader access to treatments for chronic diseases such as multiple sclerosis, Parkinson's disease, and Alzheimer's disease. “Everything in life carries risks, but in the case of chronic, debilitating conditions, the greatest risk is a lack of new and improved treatment options,” said Linda Golodner, the league's president. “It obviously makes sense for these patients to have access to as many treatment options as possible and make decisions that are right for them, even if there are additional risks.”