Joyce Frieden

WASHINGTON — The trend toward consumer-driven health care will ultimately improve overall health care quality, Regina Herzlinger, Ph.D., said at a consensus conference sponsored by the American Association of Clinical Endocrinologists.

Dr. Herzlinger, professor and chair of business administration at Harvard Business School, in Boston, contrasted the health care industry with the automotive industry. The automotive industry, which is already consumer-driven, is deflationary and features increasing product quality, lots of available product information, and widespread ownership. The health care industry, on the other hand, is not consumer-driven and is characterized by inflation, unknown quality of care, and 46 million people without health insurance.

She noted that what helped the automotive industry along was the presence of entrepreneurs, who ended up being richly rewarded for their efforts. For instance, Henry Ford, founder of the Ford Motor Co., created a new, less expensive form of steel from which to make cars. "Within a decade, car ownership went from 10,000 to 1 million," she noted.

Although Mr. Ford and other automotive industry pioneers were rewarded, innovation in health care is not well rewarded, Dr. Herzlinger continued. As an example, she cited the case of Ralph Snyderman, M.D., who came up with the idea of integrating the care of patients with heart failure by organizing care teams. "In 1 year, he lowered the costs by 40%," she said.

And what was his reward for doing so? "He lost the entire savings, because the health care system does not pay for making sick people better. It pays for days in the hospital, for doctor visits, for components of care. So the healthier he made people, the fewer people went to the hospital, the fewer doctor visits there were, and the more money he lost. Right now, if you're a Henry Ford, you're punished, and we have very poor quality," she said.

With consumer-driven health care, different products will be developed to respond to the needs of different consumers, she continued. And insurers will realize they can be rewarded for considering consumers' longer-term needs.

"I want a 5-year insurance policy. I want my insurer to really care about my long-term health," Dr. Herzlinger said. Switzerland has 5-year insurance policies, she noted, "and if, at the end of the 5 years, you're healthier than would have been predicted at the beginning, you get 45% of your money back. How's that for a good deal for the insurer, the provider, and the customer?"

Dr. Herzlinger predicted that it will become commonplace for insurers to offer integrated team care for chronic diseases. The teams "will be wired, they'll be focused, and they're going to be paid for the fact that they're dealing with sicker people," she said.

Offering such teams will be a matter of "simple economics," she continued. "You're the insurer; 80% [of your money] goes for sick people. If you want to make it cheaper and better, how better to make it cheaper and better than to go to these organizations?"

Under a consumer-driven health care system, physicians will be paid based on outcomes, "and there will be long-term contracts so you don't look at your patients in a 1-year kind of window," she said. "Investments in self-care early on will be rewarded."

One big driver behind consumer-driven health care will be aging baby boomers, a group that Dr. Herzlinger called "the most narcissistic, self-centered, empowered, and effective cohort we've ever had in the United States. The idea that this group isn't going to get what it wants, that's fantasy. They want [doctors] to integrate themselves, seize control of the system, and help patients care for their chronic diseases."

She took issue with the notion that consumer-driven health care plans will be disadvantageous to sick people. "Quite the contrary. It will finally focus attention on sick people. Right now it's in the incentive of the insurers to get rid of sick people and not to pay people who treat sick people well. But if you go to a consumer-driven system with risk-adjusted prices, the sick will be very attractive kinds of entities."

She also disputed the notion that only those who can afford high-cost plans will get the highest-quality health care. "In the car market, what is the best car in the U.S.? Toyota," she said. "Is that the highest-cost car? Not by a long shot." Instead, it's the best-quality car "because that's where all the money is. That's the mass market."

WASHINGTON — The trend toward consumer-driven health care will ultimately improve overall health care quality, Regina Herzlinger, Ph.D., said at a consensus conference sponsored by the American Association of Clinical Endocrinologists.

Dr. Herzlinger, professor and chair of business administration at Harvard Business School, in Boston, contrasted the health care industry with the automotive industry. The automotive industry, which is already consumer-driven, is deflationary and features increasing product quality, lots of available product information, and widespread ownership. The health care industry, on the other hand, is not consumer-driven and is characterized by inflation, unknown quality of care, and 46 million people without health insurance.

She noted that what helped the automotive industry along was the presence of entrepreneurs, who ended up being richly rewarded for their efforts. For instance, Henry Ford, founder of the Ford Motor Co., created a new, less expensive form of steel from which to make cars. "Within a decade, car ownership went from 10,000 to 1 million," she noted.

Although Mr. Ford and other automotive industry pioneers were rewarded, innovation in health care is not well rewarded, Dr. Herzlinger continued. As an example, she cited the case of Ralph Snyderman, M.D., who came up with the idea of integrating the care of patients with heart failure by organizing care teams. "In 1 year, he lowered the costs by 40%," she said.

And what was his reward for doing so? "He lost the entire savings, because the health care system does not pay for making sick people better. It pays for days in the hospital, for doctor visits, for components of care. So the healthier he made people, the fewer people went to the hospital, the fewer doctor visits there were, and the more money he lost. Right now, if you're a Henry Ford, you're punished, and we have very poor quality," she said.

With consumer-driven health care, different products will be developed to respond to the needs of different consumers, she continued. And insurers will realize they can be rewarded for considering consumers' longer-term needs.

"I want a 5-year insurance policy. I want my insurer to really care about my long-term health," Dr. Herzlinger said. Switzerland has 5-year insurance policies, she noted, "and if, at the end of the 5 years, you're healthier than would have been predicted at the beginning, you get 45% of your money back. How's that for a good deal for the insurer, the provider, and the customer?"

Dr. Herzlinger predicted that it will become commonplace for insurers to offer integrated team care for chronic diseases. The teams "will be wired, they'll be focused, and they're going to be paid for the fact that they're dealing with sicker people," she said.

Offering such teams will be a matter of "simple economics," she continued. "You're the insurer; 80% [of your money] goes for sick people. If you want to make it cheaper and better, how better to make it cheaper and better than to go to these organizations?"

Under a consumer-driven health care system, physicians will be paid based on outcomes, "and there will be long-term contracts so you don't look at your patients in a 1-year kind of window," she said. "Investments in self-care early on will be rewarded."

One big driver behind consumer-driven health care will be aging baby boomers, a group that Dr. Herzlinger called "the most narcissistic, self-centered, empowered, and effective cohort we've ever had in the United States. The idea that this group isn't going to get what it wants, that's fantasy. They want [doctors] to integrate themselves, seize control of the system, and help patients care for their chronic diseases."

She took issue with the notion that consumer-driven health care plans will be disadvantageous to sick people. "Quite the contrary. It will finally focus attention on sick people. Right now it's in the incentive of the insurers to get rid of sick people and not to pay people who treat sick people well. But if you go to a consumer-driven system with risk-adjusted prices, the sick will be very attractive kinds of entities."

She also disputed the notion that only those who can afford high-cost plans will get the highest-quality health care. "In the car market, what is the best car in the U.S.? Toyota," she said. "Is that the highest-cost car? Not by a long shot." Instead, it's the best-quality car "because that's where all the money is. That's the mass market."

WASHINGTON — The trend toward consumer-driven health care will ultimately improve overall health care quality, Regina Herzlinger, Ph.D., said at a consensus conference sponsored by the American Association of Clinical Endocrinologists.

Dr. Herzlinger, professor and chair of business administration at Harvard Business School, in Boston, contrasted the health care industry with the automotive industry. The automotive industry, which is already consumer-driven, is deflationary and features increasing product quality, lots of available product information, and widespread ownership. The health care industry, on the other hand, is not consumer-driven and is characterized by inflation, unknown quality of care, and 46 million people without health insurance.

She noted that what helped the automotive industry along was the presence of entrepreneurs, who ended up being richly rewarded for their efforts. For instance, Henry Ford, founder of the Ford Motor Co., created a new, less expensive form of steel from which to make cars. "Within a decade, car ownership went from 10,000 to 1 million," she noted.

Although Mr. Ford and other automotive industry pioneers were rewarded, innovation in health care is not well rewarded, Dr. Herzlinger continued. As an example, she cited the case of Ralph Snyderman, M.D., who came up with the idea of integrating the care of patients with heart failure by organizing care teams. "In 1 year, he lowered the costs by 40%," she said.

And what was his reward for doing so? "He lost the entire savings, because the health care system does not pay for making sick people better. It pays for days in the hospital, for doctor visits, for components of care. So the healthier he made people, the fewer people went to the hospital, the fewer doctor visits there were, and the more money he lost. Right now, if you're a Henry Ford, you're punished, and we have very poor quality," she said.

With consumer-driven health care, different products will be developed to respond to the needs of different consumers, she continued. And insurers will realize they can be rewarded for considering consumers' longer-term needs.

"I want a 5-year insurance policy. I want my insurer to really care about my long-term health," Dr. Herzlinger said. Switzerland has 5-year insurance policies, she noted, "and if, at the end of the 5 years, you're healthier than would have been predicted at the beginning, you get 45% of your money back. How's that for a good deal for the insurer, the provider, and the customer?"

Dr. Herzlinger predicted that it will become commonplace for insurers to offer integrated team care for chronic diseases. The teams "will be wired, they'll be focused, and they're going to be paid for the fact that they're dealing with sicker people," she said.

Offering such teams will be a matter of "simple economics," she continued. "You're the insurer; 80% [of your money] goes for sick people. If you want to make it cheaper and better, how better to make it cheaper and better than to go to these organizations?"

Under a consumer-driven health care system, physicians will be paid based on outcomes, "and there will be long-term contracts so you don't look at your patients in a 1-year kind of window," she said. "Investments in self-care early on will be rewarded."

One big driver behind consumer-driven health care will be aging baby boomers, a group that Dr. Herzlinger called "the most narcissistic, self-centered, empowered, and effective cohort we've ever had in the United States. The idea that this group isn't going to get what it wants, that's fantasy. They want [doctors] to integrate themselves, seize control of the system, and help patients care for their chronic diseases."

She took issue with the notion that consumer-driven health care plans will be disadvantageous to sick people. "Quite the contrary. It will finally focus attention on sick people. Right now it's in the incentive of the insurers to get rid of sick people and not to pay people who treat sick people well. But if you go to a consumer-driven system with risk-adjusted prices, the sick will be very attractive kinds of entities."

She also disputed the notion that only those who can afford high-cost plans will get the highest-quality health care. "In the car market, what is the best car in the U.S.? Toyota," she said. "Is that the highest-cost car? Not by a long shot." Instead, it's the best-quality car "because that's where all the money is. That's the mass market."

WASHINGTON — Improving health information technology could go a long way toward eliminating disparities in health care, Newt Gingrich said at a meeting sponsored by the Alliance of Minority Medical Associations, the National Association for Equal Opportunity in Higher Education, and the Department of Health and Human Services.

"The challenge is not to be futurist but to bring health care up to the world of the last 20 years," said Mr. Gingrich, former speaker of the House of Representatives and founder of the Center for Health Transformation.

He criticized a recently adopted Florida law that requires physicians to print legibly when they write prescriptions. "First, it's a fantasy to think legislation will convince doctors to print legibly. Secondly, it's the wrong direction for change," he said. "Even a clearly printed prescription remains a paper prescription and misses all the opportunities for checking medication errors, checking other medications, and seeing if there are contraindications. In the long run, the future is an electronic prescription with an expert system to make sure you get the right medication."

People will need to think more creatively, he continued. "Imagine that the medical profession went to major cell phone manufacturers and said, 'We want you to develop a camera capability on a cell phone sufficiently vivid that we could do emergency diagnostics by phone.'"

At the same time, the health care industry needs to find better ways to standardize itself and to disperse information about best practices in medicine, Mr. Gingrich continued. "It can take 17 years for a best practice to reach the average doctor," he said. "We want to set a standard and migrate everybody to that standard."

He gave an example of how electronic health records could improve the standard of care. "A friend's father went in for an MRI, and her mother went in with him. They filled out five paper forms before the MRI. The mother happened to go into the doctor's office as they were preparing to do the MRI, and she said, 'You did know he has a pacemaker?' They stopped right there."

But if the patient had had an electronic health record, "that would have been obvious and automatic, and the expert system would check against it," Mr. Gingrich said, noting that his center is trying to develop "a 21st-century intelligent health system which we believe will end health disparities in America in terms of the delivery of services."

However, such a system would not improve disparities based on culture or ethnicity unless certain problems are addressed, he continued. For example, "diabetes is largely a cultural issue. How you treat diabetes is a medical issue, but how you avoid diabetes is a cultural issue."

Since obesity plays a part in the development of diabetes, he urged audience members to push their home states to institute mandatory, 1-hour daily physical education in public schools and also to ban unhealthy foods from the schools. States that don't do these things "are not serious about obesity in children," he said.

After electronic health records are in place in hospitals and physicians' offices, the next step should be a "Personal Health Knowledge System," Mr. Gingrich continued. The system would be accessible to patients online and would contain genetic profiles that might tell patients such things as whether they have a particular genetic makeup that puts them in the 10% of people who should not eat too many high-fiber foods because doing so could trigger colon cancer, he said.

"You should actually know your DNA before you go grocery shopping," he said. "Within a decade, we'll have an expert system where you'll be able to punch in your health status and it will print out a grocery list."

In fact, food purchases also can be used as an incentive: "If you want to truly help health disparities among the poor, you may want to give bonus points if you use food stamps for the right foods," Mr. Gingrich said. "That sounds like micromanagement, but we've got to be practical about how to shift behavior patterns when people are used to eating food that kills them."

WASHINGTON — Improving health information technology could go a long way toward eliminating disparities in health care, Newt Gingrich said at a meeting sponsored by the Alliance of Minority Medical Associations, the National Association for Equal Opportunity in Higher Education, and the Department of Health and Human Services.

"The challenge is not to be futurist but to bring health care up to the world of the last 20 years," said Mr. Gingrich, former speaker of the House of Representatives and founder of the Center for Health Transformation.

He criticized a recently adopted Florida law that requires physicians to print legibly when they write prescriptions. "First, it's a fantasy to think legislation will convince doctors to print legibly. Secondly, it's the wrong direction for change," he said. "Even a clearly printed prescription remains a paper prescription and misses all the opportunities for checking medication errors, checking other medications, and seeing if there are contraindications. In the long run, the future is an electronic prescription with an expert system to make sure you get the right medication."

People will need to think more creatively, he continued. "Imagine that the medical profession went to major cell phone manufacturers and said, 'We want you to develop a camera capability on a cell phone sufficiently vivid that we could do emergency diagnostics by phone.'"

At the same time, the health care industry needs to find better ways to standardize itself and to disperse information about best practices in medicine, Mr. Gingrich continued. "It can take 17 years for a best practice to reach the average doctor," he said. "We want to set a standard and migrate everybody to that standard."

He gave an example of how electronic health records could improve the standard of care. "A friend's father went in for an MRI, and her mother went in with him. They filled out five paper forms before the MRI. The mother happened to go into the doctor's office as they were preparing to do the MRI, and she said, 'You did know he has a pacemaker?' They stopped right there."

But if the patient had had an electronic health record, "that would have been obvious and automatic, and the expert system would check against it," Mr. Gingrich said, noting that his center is trying to develop "a 21st-century intelligent health system which we believe will end health disparities in America in terms of the delivery of services."

However, such a system would not improve disparities based on culture or ethnicity unless certain problems are addressed, he continued. For example, "diabetes is largely a cultural issue. How you treat diabetes is a medical issue, but how you avoid diabetes is a cultural issue."

Since obesity plays a part in the development of diabetes, he urged audience members to push their home states to institute mandatory, 1-hour daily physical education in public schools and also to ban unhealthy foods from the schools. States that don't do these things "are not serious about obesity in children," he said.

After electronic health records are in place in hospitals and physicians' offices, the next step should be a "Personal Health Knowledge System," Mr. Gingrich continued. The system would be accessible to patients online and would contain genetic profiles that might tell patients such things as whether they have a particular genetic makeup that puts them in the 10% of people who should not eat too many high-fiber foods because doing so could trigger colon cancer, he said.

"You should actually know your DNA before you go grocery shopping," he said. "Within a decade, we'll have an expert system where you'll be able to punch in your health status and it will print out a grocery list."

In fact, food purchases also can be used as an incentive: "If you want to truly help health disparities among the poor, you may want to give bonus points if you use food stamps for the right foods," Mr. Gingrich said. "That sounds like micromanagement, but we've got to be practical about how to shift behavior patterns when people are used to eating food that kills them."

WASHINGTON — Improving health information technology could go a long way toward eliminating disparities in health care, Newt Gingrich said at a meeting sponsored by the Alliance of Minority Medical Associations, the National Association for Equal Opportunity in Higher Education, and the Department of Health and Human Services.

"The challenge is not to be futurist but to bring health care up to the world of the last 20 years," said Mr. Gingrich, former speaker of the House of Representatives and founder of the Center for Health Transformation.

He criticized a recently adopted Florida law that requires physicians to print legibly when they write prescriptions. "First, it's a fantasy to think legislation will convince doctors to print legibly. Secondly, it's the wrong direction for change," he said. "Even a clearly printed prescription remains a paper prescription and misses all the opportunities for checking medication errors, checking other medications, and seeing if there are contraindications. In the long run, the future is an electronic prescription with an expert system to make sure you get the right medication."

People will need to think more creatively, he continued. "Imagine that the medical profession went to major cell phone manufacturers and said, 'We want you to develop a camera capability on a cell phone sufficiently vivid that we could do emergency diagnostics by phone.'"

At the same time, the health care industry needs to find better ways to standardize itself and to disperse information about best practices in medicine, Mr. Gingrich continued. "It can take 17 years for a best practice to reach the average doctor," he said. "We want to set a standard and migrate everybody to that standard."

He gave an example of how electronic health records could improve the standard of care. "A friend's father went in for an MRI, and her mother went in with him. They filled out five paper forms before the MRI. The mother happened to go into the doctor's office as they were preparing to do the MRI, and she said, 'You did know he has a pacemaker?' They stopped right there."

But if the patient had had an electronic health record, "that would have been obvious and automatic, and the expert system would check against it," Mr. Gingrich said, noting that his center is trying to develop "a 21st-century intelligent health system which we believe will end health disparities in America in terms of the delivery of services."

However, such a system would not improve disparities based on culture or ethnicity unless certain problems are addressed, he continued. For example, "diabetes is largely a cultural issue. How you treat diabetes is a medical issue, but how you avoid diabetes is a cultural issue."

Since obesity plays a part in the development of diabetes, he urged audience members to push their home states to institute mandatory, 1-hour daily physical education in public schools and also to ban unhealthy foods from the schools. States that don't do these things "are not serious about obesity in children," he said.

After electronic health records are in place in hospitals and physicians' offices, the next step should be a "Personal Health Knowledge System," Mr. Gingrich continued. The system would be accessible to patients online and would contain genetic profiles that might tell patients such things as whether they have a particular genetic makeup that puts them in the 10% of people who should not eat too many high-fiber foods because doing so could trigger colon cancer, he said.

"You should actually know your DNA before you go grocery shopping," he said. "Within a decade, we'll have an expert system where you'll be able to punch in your health status and it will print out a grocery list."

In fact, food purchases also can be used as an incentive: "If you want to truly help health disparities among the poor, you may want to give bonus points if you use food stamps for the right foods," Mr. Gingrich said. "That sounds like micromanagement, but we've got to be practical about how to shift behavior patterns when people are used to eating food that kills them."

WASHINGTON — Health care disparities among ethnic groups should be considered a form of medical error, James Gavin, M.D., said at a consensus conference on patient safety and medical system errors in diabetes and endocrinology.

"When we see disparities, that really is a reflection of inadequate patient safety," said Dr. Gavin, who is past president and professor of medicine at Morehouse School of Medicine, Atlanta. "It means that under the same or similar conditions of risk or exposure, the outcomes are sufficiently different that there is some disadvantage conferred on one of the other subject populations."

One example is coronary heart disease (CHD), he said at the conference, sponsored by the American Association of Clinical Endocrinologists. "There is a real difference in CHD mortality in black males, compared with whites at every age stratum. It doesn't start to even out until you get to the ninth decade of life. I'd be very concerned about these kinds of numbers."

Results like these are in part a reflection of how medical decisions are made for different patients, and, sometimes, the only way to get at that information is by looking at surrogates for decision making, such as utilization rates, Dr. Gavin said.

For instance, coronary artery bypass graft surgery (CABG) has proved to be of significant benefit in high-risk patients, and yet "CABG is significantly underutilized in blacks, compared with whites," he said. On the other hand, data on amputation among patients with diabetes "suggest it is significantly more utilized in blacks, compared with whites. Something is driving these outcomes."

Part of the problem may be bad information, he said. A report from a commission chartered in the 1980s by Health and Human Services Secretary Margaret Heckler found several myths about heart disease in blacks, including the idea that blacks rarely had myocardial infarctions or angina, or that they were immune to CHD.

"Because of flaws in the way data were interpreted, they were actually underreporting CHD as a cause of death, when … CHD was actually the leading cause of death in U.S. blacks then just as it is now," Dr. Gavin noted.

Now that researchers are looking at disparities more systematically, they are finding that even when minorities have access to health care that is equivalent to that of white patients, there is still an inequity in the services they receive, he said.

"That part of the gap that is attributable to patient needs and patient preferences you have to back out [of the equation] because you can't blame a patient's choice," he said. "But these other issues, the way the system operates, the way individual and group biases and prejudices [affect things], those issues are major drivers."

Medicare data on diabetes care show that something is clearly "amiss," he continued. "For example, despite the greater prevalence and risk associated with it, African Americans are less likely to undergo hemoglobin A_1c testing, or to have their lipids tested, or to have vaccinations. And this is in the Medicare population, where coverage is not the issue."

In another instance of disparities in diabetes care, African Americans account for 12% of the population, "but fully a third or more of the [end-stage renal disease] population," Dr. Gavin explained. African American patients also "are less likely to receive a kidney transplant and less likely to be referred for a transplant, or to be placed on a transplant waiting list. Those are decisions that someone has to make."

Some of the health care disparities arise from the clinical encounter itself. "It's at that level we have to begin to pay more attention because it is only to the extent that we improve the quality of this encounter … that we will begin to influence this process," Dr. Gavin said. "There will be less ambiguity, less misunderstanding, and we'll begin to mitigate the influence of prejudices, no matter who brings them to the table."

Dr. Gavin said he didn't agree with the idea of "cultural competency." "It's not something I'm convinced we ever become competent at. It's always a work in progress. But [we] can work to become more self-aware of our own cultural norms and values that will quickly lead us to misjudge or miscommunicate with others."

One problem with cultural competency training, for instance, is that it can confer a false level of confidence, he noted. "We think we can go to one workshop and come out culturally competent, when in fact it's lifelong learning. And we have to be careful not to reinforce cultural stereotypes."

Finally, even those who attend such courses should remember that attendance does not substitute for having culturally representative health care teams. "We can never lose sight of that," he said.

WASHINGTON — Health care disparities among ethnic groups should be considered a form of medical error, James Gavin, M.D., said at a consensus conference on patient safety and medical system errors in diabetes and endocrinology.

"When we see disparities, that really is a reflection of inadequate patient safety," said Dr. Gavin, who is past president and professor of medicine at Morehouse School of Medicine, Atlanta. "It means that under the same or similar conditions of risk or exposure, the outcomes are sufficiently different that there is some disadvantage conferred on one of the other subject populations."

One example is coronary heart disease (CHD), he said at the conference, sponsored by the American Association of Clinical Endocrinologists. "There is a real difference in CHD mortality in black males, compared with whites at every age stratum. It doesn't start to even out until you get to the ninth decade of life. I'd be very concerned about these kinds of numbers."

Results like these are in part a reflection of how medical decisions are made for different patients, and, sometimes, the only way to get at that information is by looking at surrogates for decision making, such as utilization rates, Dr. Gavin said.

For instance, coronary artery bypass graft surgery (CABG) has proved to be of significant benefit in high-risk patients, and yet "CABG is significantly underutilized in blacks, compared with whites," he said. On the other hand, data on amputation among patients with diabetes "suggest it is significantly more utilized in blacks, compared with whites. Something is driving these outcomes."

Part of the problem may be bad information, he said. A report from a commission chartered in the 1980s by Health and Human Services Secretary Margaret Heckler found several myths about heart disease in blacks, including the idea that blacks rarely had myocardial infarctions or angina, or that they were immune to CHD.

"Because of flaws in the way data were interpreted, they were actually underreporting CHD as a cause of death, when … CHD was actually the leading cause of death in U.S. blacks then just as it is now," Dr. Gavin noted.

Now that researchers are looking at disparities more systematically, they are finding that even when minorities have access to health care that is equivalent to that of white patients, there is still an inequity in the services they receive, he said.

"That part of the gap that is attributable to patient needs and patient preferences you have to back out [of the equation] because you can't blame a patient's choice," he said. "But these other issues, the way the system operates, the way individual and group biases and prejudices [affect things], those issues are major drivers."

Medicare data on diabetes care show that something is clearly "amiss," he continued. "For example, despite the greater prevalence and risk associated with it, African Americans are less likely to undergo hemoglobin A_1c testing, or to have their lipids tested, or to have vaccinations. And this is in the Medicare population, where coverage is not the issue."

In another instance of disparities in diabetes care, African Americans account for 12% of the population, "but fully a third or more of the [end-stage renal disease] population," Dr. Gavin explained. African American patients also "are less likely to receive a kidney transplant and less likely to be referred for a transplant, or to be placed on a transplant waiting list. Those are decisions that someone has to make."

Some of the health care disparities arise from the clinical encounter itself. "It's at that level we have to begin to pay more attention because it is only to the extent that we improve the quality of this encounter … that we will begin to influence this process," Dr. Gavin said. "There will be less ambiguity, less misunderstanding, and we'll begin to mitigate the influence of prejudices, no matter who brings them to the table."

Dr. Gavin said he didn't agree with the idea of "cultural competency." "It's not something I'm convinced we ever become competent at. It's always a work in progress. But [we] can work to become more self-aware of our own cultural norms and values that will quickly lead us to misjudge or miscommunicate with others."

One problem with cultural competency training, for instance, is that it can confer a false level of confidence, he noted. "We think we can go to one workshop and come out culturally competent, when in fact it's lifelong learning. And we have to be careful not to reinforce cultural stereotypes."

Finally, even those who attend such courses should remember that attendance does not substitute for having culturally representative health care teams. "We can never lose sight of that," he said.

WASHINGTON — Health care disparities among ethnic groups should be considered a form of medical error, James Gavin, M.D., said at a consensus conference on patient safety and medical system errors in diabetes and endocrinology.

"When we see disparities, that really is a reflection of inadequate patient safety," said Dr. Gavin, who is past president and professor of medicine at Morehouse School of Medicine, Atlanta. "It means that under the same or similar conditions of risk or exposure, the outcomes are sufficiently different that there is some disadvantage conferred on one of the other subject populations."

One example is coronary heart disease (CHD), he said at the conference, sponsored by the American Association of Clinical Endocrinologists. "There is a real difference in CHD mortality in black males, compared with whites at every age stratum. It doesn't start to even out until you get to the ninth decade of life. I'd be very concerned about these kinds of numbers."

Results like these are in part a reflection of how medical decisions are made for different patients, and, sometimes, the only way to get at that information is by looking at surrogates for decision making, such as utilization rates, Dr. Gavin said.

For instance, coronary artery bypass graft surgery (CABG) has proved to be of significant benefit in high-risk patients, and yet "CABG is significantly underutilized in blacks, compared with whites," he said. On the other hand, data on amputation among patients with diabetes "suggest it is significantly more utilized in blacks, compared with whites. Something is driving these outcomes."

Part of the problem may be bad information, he said. A report from a commission chartered in the 1980s by Health and Human Services Secretary Margaret Heckler found several myths about heart disease in blacks, including the idea that blacks rarely had myocardial infarctions or angina, or that they were immune to CHD.

"Because of flaws in the way data were interpreted, they were actually underreporting CHD as a cause of death, when … CHD was actually the leading cause of death in U.S. blacks then just as it is now," Dr. Gavin noted.

Now that researchers are looking at disparities more systematically, they are finding that even when minorities have access to health care that is equivalent to that of white patients, there is still an inequity in the services they receive, he said.

"That part of the gap that is attributable to patient needs and patient preferences you have to back out [of the equation] because you can't blame a patient's choice," he said. "But these other issues, the way the system operates, the way individual and group biases and prejudices [affect things], those issues are major drivers."

Medicare data on diabetes care show that something is clearly "amiss," he continued. "For example, despite the greater prevalence and risk associated with it, African Americans are less likely to undergo hemoglobin A_1c testing, or to have their lipids tested, or to have vaccinations. And this is in the Medicare population, where coverage is not the issue."

In another instance of disparities in diabetes care, African Americans account for 12% of the population, "but fully a third or more of the [end-stage renal disease] population," Dr. Gavin explained. African American patients also "are less likely to receive a kidney transplant and less likely to be referred for a transplant, or to be placed on a transplant waiting list. Those are decisions that someone has to make."

Some of the health care disparities arise from the clinical encounter itself. "It's at that level we have to begin to pay more attention because it is only to the extent that we improve the quality of this encounter … that we will begin to influence this process," Dr. Gavin said. "There will be less ambiguity, less misunderstanding, and we'll begin to mitigate the influence of prejudices, no matter who brings them to the table."

Dr. Gavin said he didn't agree with the idea of "cultural competency." "It's not something I'm convinced we ever become competent at. It's always a work in progress. But [we] can work to become more self-aware of our own cultural norms and values that will quickly lead us to misjudge or miscommunicate with others."

One problem with cultural competency training, for instance, is that it can confer a false level of confidence, he noted. "We think we can go to one workshop and come out culturally competent, when in fact it's lifelong learning. And we have to be careful not to reinforce cultural stereotypes."

Finally, even those who attend such courses should remember that attendance does not substitute for having culturally representative health care teams. "We can never lose sight of that," he said.

WASHINGTON — More needs to be done to encourage minority patients and providers to participate in clinical drug trials, several speakers said at a meeting sponsored by the Alliance of Minority Medical Associations, the National Association for Equal Opportunity in Higher Education, and the Department of Health and Human Services.

“If you go to the package insert of a lot of drugs currently on the market and look for information on minority participation in clinical trials, what you frequently will see is the phrase, 'No data available,'” said Basil Halliday, founder of BDH Clinical Research Services, a clinical trial consulting firm in Ridgemont, N.C. “It's high time we get rid of that phrase in the package insert.”

One of the most important changes would be a federal mandate to include minority patients in clinical trials as a condition of approval by the Food and Drug Administration. “We also need specific guidance on the degree of representation,” Mr. Halliday said. “I don't want to hear you say that you 'encourage it,' 'support it,' or 'want to see more of it.' You need to give specific numbers because that's the only time the industry will respond. I say mandate, mandate, mandate.”

B. Waine Kong, Ph.D., CEO of the Association of Black Cardiologists, suggested that the FDA establish an Office of Minority Affairs to address issues relating to minorities, including increasing their participation in clinical trials.

Several barriers impede minority participation in trials, among them a lack of minority physicians, who are six times more likely to treat minority patients, compared with white physicians, Mr. Halliday said. “As for African American physicians doing clinical trials, it's almost nonexistent.”

Mr. Halliday's company has started the Clinical Research Investigator Support Program to encourage more minority physician participation. “We need to do a better job of creating a pipeline of future physicians, minority scientists, and researchers who are culturally competent and culturally sensitive to the people they're six times more likely to treat,” he said. “We need to involve those people in the process early.”

Minority physicians have a lot of reservations about participating in clinical trials, he continued. “A lot of physicians I have talked to over the years don't know that the pharmaceutical industry had nothing to do with Tuskegee,” Mr. Halliday said, referring to an experiment conducted by the U.S. Public Health Service in which African American men were deliberately left untreated for syphilis, even after penicillin became known as a cure for the disease.

Dr. Kong noted that minority physicians also face a variety of entry barriers to clinical trials, such as complex, technical forms to fill out and the need for capital investment, including hiring someone to help run the trial. Further, many minority physicians are reticent to refer patients to trials being run by other physicians “because of a belief that if they send that patient to another doctor, they may lose that patient. That's not necessarily true.”

On the patient side, minority patients need to be better educated about the benefits of trial participation, such as free, state-of-the-art medical care and better outcomes due to more frequent physician visits, Mr. Halliday said.

He said that his company also has started a minority community outreach and education program with institutional review boards. “It doesn't make sense that the folks sitting on the IRB and approving protocols don't accurately reflect the communities in which they live,” he said. He complimented one board, Essex IRB in Lebanon, N.J., for changing its board makeup to allow for more minority participation.

Mr. Halliday urged the National Institutes of Health to start grant reviewer education programs about minority inclusion in clinical trials. “The same folks, year after year, get money from NIH, but there's no demand on those people to change. We need to hold them accountable for putting minorities in the clinical trial process.”

WASHINGTON — More needs to be done to encourage minority patients and providers to participate in clinical drug trials, several speakers said at a meeting sponsored by the Alliance of Minority Medical Associations, the National Association for Equal Opportunity in Higher Education, and the Department of Health and Human Services.

“If you go to the package insert of a lot of drugs currently on the market and look for information on minority participation in clinical trials, what you frequently will see is the phrase, 'No data available,'” said Basil Halliday, founder of BDH Clinical Research Services, a clinical trial consulting firm in Ridgemont, N.C. “It's high time we get rid of that phrase in the package insert.”

One of the most important changes would be a federal mandate to include minority patients in clinical trials as a condition of approval by the Food and Drug Administration. “We also need specific guidance on the degree of representation,” Mr. Halliday said. “I don't want to hear you say that you 'encourage it,' 'support it,' or 'want to see more of it.' You need to give specific numbers because that's the only time the industry will respond. I say mandate, mandate, mandate.”

B. Waine Kong, Ph.D., CEO of the Association of Black Cardiologists, suggested that the FDA establish an Office of Minority Affairs to address issues relating to minorities, including increasing their participation in clinical trials.

Several barriers impede minority participation in trials, among them a lack of minority physicians, who are six times more likely to treat minority patients, compared with white physicians, Mr. Halliday said. “As for African American physicians doing clinical trials, it's almost nonexistent.”

Mr. Halliday's company has started the Clinical Research Investigator Support Program to encourage more minority physician participation. “We need to do a better job of creating a pipeline of future physicians, minority scientists, and researchers who are culturally competent and culturally sensitive to the people they're six times more likely to treat,” he said. “We need to involve those people in the process early.”

Minority physicians have a lot of reservations about participating in clinical trials, he continued. “A lot of physicians I have talked to over the years don't know that the pharmaceutical industry had nothing to do with Tuskegee,” Mr. Halliday said, referring to an experiment conducted by the U.S. Public Health Service in which African American men were deliberately left untreated for syphilis, even after penicillin became known as a cure for the disease.

Dr. Kong noted that minority physicians also face a variety of entry barriers to clinical trials, such as complex, technical forms to fill out and the need for capital investment, including hiring someone to help run the trial. Further, many minority physicians are reticent to refer patients to trials being run by other physicians “because of a belief that if they send that patient to another doctor, they may lose that patient. That's not necessarily true.”

On the patient side, minority patients need to be better educated about the benefits of trial participation, such as free, state-of-the-art medical care and better outcomes due to more frequent physician visits, Mr. Halliday said.

He said that his company also has started a minority community outreach and education program with institutional review boards. “It doesn't make sense that the folks sitting on the IRB and approving protocols don't accurately reflect the communities in which they live,” he said. He complimented one board, Essex IRB in Lebanon, N.J., for changing its board makeup to allow for more minority participation.

Mr. Halliday urged the National Institutes of Health to start grant reviewer education programs about minority inclusion in clinical trials. “The same folks, year after year, get money from NIH, but there's no demand on those people to change. We need to hold them accountable for putting minorities in the clinical trial process.”

WASHINGTON — More needs to be done to encourage minority patients and providers to participate in clinical drug trials, several speakers said at a meeting sponsored by the Alliance of Minority Medical Associations, the National Association for Equal Opportunity in Higher Education, and the Department of Health and Human Services.

“If you go to the package insert of a lot of drugs currently on the market and look for information on minority participation in clinical trials, what you frequently will see is the phrase, 'No data available,'” said Basil Halliday, founder of BDH Clinical Research Services, a clinical trial consulting firm in Ridgemont, N.C. “It's high time we get rid of that phrase in the package insert.”

One of the most important changes would be a federal mandate to include minority patients in clinical trials as a condition of approval by the Food and Drug Administration. “We also need specific guidance on the degree of representation,” Mr. Halliday said. “I don't want to hear you say that you 'encourage it,' 'support it,' or 'want to see more of it.' You need to give specific numbers because that's the only time the industry will respond. I say mandate, mandate, mandate.”

B. Waine Kong, Ph.D., CEO of the Association of Black Cardiologists, suggested that the FDA establish an Office of Minority Affairs to address issues relating to minorities, including increasing their participation in clinical trials.

Several barriers impede minority participation in trials, among them a lack of minority physicians, who are six times more likely to treat minority patients, compared with white physicians, Mr. Halliday said. “As for African American physicians doing clinical trials, it's almost nonexistent.”

Mr. Halliday's company has started the Clinical Research Investigator Support Program to encourage more minority physician participation. “We need to do a better job of creating a pipeline of future physicians, minority scientists, and researchers who are culturally competent and culturally sensitive to the people they're six times more likely to treat,” he said. “We need to involve those people in the process early.”

Minority physicians have a lot of reservations about participating in clinical trials, he continued. “A lot of physicians I have talked to over the years don't know that the pharmaceutical industry had nothing to do with Tuskegee,” Mr. Halliday said, referring to an experiment conducted by the U.S. Public Health Service in which African American men were deliberately left untreated for syphilis, even after penicillin became known as a cure for the disease.

Dr. Kong noted that minority physicians also face a variety of entry barriers to clinical trials, such as complex, technical forms to fill out and the need for capital investment, including hiring someone to help run the trial. Further, many minority physicians are reticent to refer patients to trials being run by other physicians “because of a belief that if they send that patient to another doctor, they may lose that patient. That's not necessarily true.”

On the patient side, minority patients need to be better educated about the benefits of trial participation, such as free, state-of-the-art medical care and better outcomes due to more frequent physician visits, Mr. Halliday said.

He said that his company also has started a minority community outreach and education program with institutional review boards. “It doesn't make sense that the folks sitting on the IRB and approving protocols don't accurately reflect the communities in which they live,” he said. He complimented one board, Essex IRB in Lebanon, N.J., for changing its board makeup to allow for more minority participation.

Mr. Halliday urged the National Institutes of Health to start grant reviewer education programs about minority inclusion in clinical trials. “The same folks, year after year, get money from NIH, but there's no demand on those people to change. We need to hold them accountable for putting minorities in the clinical trial process.”

WASHINGTON — The use of at-home genetic tests raises ethical dilemmas for both patients and physicians, several speakers said at a forum sponsored by the Johns Hopkins University Genetics and Public Policy Center.

“Let's be practical,” said Richard T. Scott Jr., M.D., who is a founding partner of Reproductive Medicine Associates of New Jersey in Morristown. “I'm fortunate because I'm a subspecialist—when I meet with my patients, I usually get an hour. But now you're an internist—you have 7 to 10 minutes. The patients are going to walk in with their letter [summarizing their test results], and you've got 7 minutes to get through that, it's going to create a problem.”

In general, “things which move patients toward being better informed so they have a better understanding of their circumstances and make better decisions in their life, including treatment decisions, have to be good,” he added.

“But when it comes to putting these tests together, the real question will be what tests are you going to offer, and how are you going to decide if those tests are appropriate?” he said.

Whether physicians want them or not, at-home genetic tests are out there. Many of the tests available are for fertility- or gynecologic-related conditions.

One company, San Francisco-based DNA Direct, offers tests for BRCA mutations, thrombophilia, hemochromatosis, cystic fibrosis, and α₁-antitrypsin deficiency. Prices for the tests range from $199 to $3,311 and include a “personalized report” of the results and phone consultation with a genetic expert.

Many of the tests are done with a cheek swab; the sample is sent through the mail.

For tests that require a blood sample, the customer is directed to a federally certified lab that collects the sample and then ships it in the manner required, according to Ryan Phelan, DNA Direct's founder and CEO. In either case, the customer remains anonymous throughout the process.

Michael Mennuti, M.D., chair of the obstetrics and gynecology department at the Hospital of the University of Pennsylvania in Philadelphia, also expressed concerns.

For instance, “when you have laboratory tests available to patients who have a problem, and you report a normal result [on the first test], then the patient's next question is, 'Well, what is causing this problem, and what's the next test?'” said Dr. Mennuti, who is also president-elect of the American College of Obstetricians and Gynecologists. “Here you're communicating with someone who has an employer-employee relationship with the laboratory. There is a potential for a conflict of interest.”

Customers have several reasons for using at-home tests, Ms. Phelan said.

“One is access to a test that their physician did not know about, did not choose to offer, or did not recommend. Number two is to get it interpreted by experts who actually understand the nuances. And third is insurance discrimination or worry about insurance discrimination,” she explained.

Physicians' lack of genetic knowledge is a real issue, said R. Alta Charo, professor of law and medical ethics at the University of Wisconsin at Madison.

She noted that when she worked for the now-defunct Federal Office of Technology Assessment about 15 years ago, the office did a study on sperm donation and surveyed physicians about their choices of men they would allow to donate for their patients.

“We discovered a woeful lack of understanding of basic genetics,” she said.

“They would screen out perfectly healthy men who had first-degree relatives with hemophilia—apparently not recognizing that if they were healthy they couldn't have the hemophilia mutation—but would allow in men who had parents with Huntington's chorea and who were young enough not have presented [with symptoms].”

Although medical schools have since made great strides in these areas, “I would suspect that there is still a relative lack of sophisticated understanding of modern genetics prevalent among many physicians, and therefore they may not pick up the kind of things patients might have that would explain their symptoms,” Ms. Charo continued.

“One of the advantages [of at-home tests] is that people may detect something that may otherwise go overlooked,” she said.

Some panelists expressed concern at the lack of regulation of at-home genetic tests.

Gail Javitt, policy analyst at the Genetics and Public Policy Center, noted that state laws applying to at-home tests vary greatly.

“Some states require a health care provider to order a test and get the results back; other states don't require this,” Ms. Javitt pointed out. But “even when a provider's involvement is required, it does not necessarily have to be the patient's personal physician. It can be a provider associated with the company offering the test.”

As for the actual tests, there is little government oversight, she continued. “Most genetic tests are provided by clinical laboratories, and the laboratory director decides when to offer the tests and what tests to offer.

“Labs are subject to general quality standards, but these are not genetic test-specific. Of the more than 800 tests currently out there, only a handful are regulated by the [Food and Drug Administration]. Indeed, FDA provides more oversight for home pregnancy tests than it does today for most genetic tests,” she said.

Steve Gutman of the FDA's Office of In Vitro Diagnostics, who was in the audience, said that the FDA is “not disinterested” in this area.

The agency “is not unaware of very colorful array of forces that are operating here, and it does not have easy answers. The unanswered question is how the FDA might move from the small set of commercial tests it now regulates to broader regulation of building blocks of home-brewed tests or the home-brewed tests themselves.

“I can't make any promise about timelines, but I can make a promise that the last chapter hasn't been written. It's a novel in progress,” he noted

WASHINGTON — The use of at-home genetic tests raises ethical dilemmas for both patients and physicians, several speakers said at a forum sponsored by the Johns Hopkins University Genetics and Public Policy Center.

“Let's be practical,” said Richard T. Scott Jr., M.D., who is a founding partner of Reproductive Medicine Associates of New Jersey in Morristown. “I'm fortunate because I'm a subspecialist—when I meet with my patients, I usually get an hour. But now you're an internist—you have 7 to 10 minutes. The patients are going to walk in with their letter [summarizing their test results], and you've got 7 minutes to get through that, it's going to create a problem.”

In general, “things which move patients toward being better informed so they have a better understanding of their circumstances and make better decisions in their life, including treatment decisions, have to be good,” he added.

“But when it comes to putting these tests together, the real question will be what tests are you going to offer, and how are you going to decide if those tests are appropriate?” he said.

Whether physicians want them or not, at-home genetic tests are out there. Many of the tests available are for fertility- or gynecologic-related conditions.

One company, San Francisco-based DNA Direct, offers tests for BRCA mutations, thrombophilia, hemochromatosis, cystic fibrosis, and α₁-antitrypsin deficiency. Prices for the tests range from $199 to $3,311 and include a “personalized report” of the results and phone consultation with a genetic expert.

Many of the tests are done with a cheek swab; the sample is sent through the mail.

For tests that require a blood sample, the customer is directed to a federally certified lab that collects the sample and then ships it in the manner required, according to Ryan Phelan, DNA Direct's founder and CEO. In either case, the customer remains anonymous throughout the process.

Michael Mennuti, M.D., chair of the obstetrics and gynecology department at the Hospital of the University of Pennsylvania in Philadelphia, also expressed concerns.

For instance, “when you have laboratory tests available to patients who have a problem, and you report a normal result [on the first test], then the patient's next question is, 'Well, what is causing this problem, and what's the next test?'” said Dr. Mennuti, who is also president-elect of the American College of Obstetricians and Gynecologists. “Here you're communicating with someone who has an employer-employee relationship with the laboratory. There is a potential for a conflict of interest.”

Customers have several reasons for using at-home tests, Ms. Phelan said.

“One is access to a test that their physician did not know about, did not choose to offer, or did not recommend. Number two is to get it interpreted by experts who actually understand the nuances. And third is insurance discrimination or worry about insurance discrimination,” she explained.

Physicians' lack of genetic knowledge is a real issue, said R. Alta Charo, professor of law and medical ethics at the University of Wisconsin at Madison.

She noted that when she worked for the now-defunct Federal Office of Technology Assessment about 15 years ago, the office did a study on sperm donation and surveyed physicians about their choices of men they would allow to donate for their patients.

“We discovered a woeful lack of understanding of basic genetics,” she said.

“They would screen out perfectly healthy men who had first-degree relatives with hemophilia—apparently not recognizing that if they were healthy they couldn't have the hemophilia mutation—but would allow in men who had parents with Huntington's chorea and who were young enough not have presented [with symptoms].”

Although medical schools have since made great strides in these areas, “I would suspect that there is still a relative lack of sophisticated understanding of modern genetics prevalent among many physicians, and therefore they may not pick up the kind of things patients might have that would explain their symptoms,” Ms. Charo continued.

“One of the advantages [of at-home tests] is that people may detect something that may otherwise go overlooked,” she said.

Some panelists expressed concern at the lack of regulation of at-home genetic tests.

Gail Javitt, policy analyst at the Genetics and Public Policy Center, noted that state laws applying to at-home tests vary greatly.

“Some states require a health care provider to order a test and get the results back; other states don't require this,” Ms. Javitt pointed out. But “even when a provider's involvement is required, it does not necessarily have to be the patient's personal physician. It can be a provider associated with the company offering the test.”

As for the actual tests, there is little government oversight, she continued. “Most genetic tests are provided by clinical laboratories, and the laboratory director decides when to offer the tests and what tests to offer.

“Labs are subject to general quality standards, but these are not genetic test-specific. Of the more than 800 tests currently out there, only a handful are regulated by the [Food and Drug Administration]. Indeed, FDA provides more oversight for home pregnancy tests than it does today for most genetic tests,” she said.

Steve Gutman of the FDA's Office of In Vitro Diagnostics, who was in the audience, said that the FDA is “not disinterested” in this area.

The agency “is not unaware of very colorful array of forces that are operating here, and it does not have easy answers. The unanswered question is how the FDA might move from the small set of commercial tests it now regulates to broader regulation of building blocks of home-brewed tests or the home-brewed tests themselves.

“I can't make any promise about timelines, but I can make a promise that the last chapter hasn't been written. It's a novel in progress,” he noted

WASHINGTON — The use of at-home genetic tests raises ethical dilemmas for both patients and physicians, several speakers said at a forum sponsored by the Johns Hopkins University Genetics and Public Policy Center.

“Let's be practical,” said Richard T. Scott Jr., M.D., who is a founding partner of Reproductive Medicine Associates of New Jersey in Morristown. “I'm fortunate because I'm a subspecialist—when I meet with my patients, I usually get an hour. But now you're an internist—you have 7 to 10 minutes. The patients are going to walk in with their letter [summarizing their test results], and you've got 7 minutes to get through that, it's going to create a problem.”

In general, “things which move patients toward being better informed so they have a better understanding of their circumstances and make better decisions in their life, including treatment decisions, have to be good,” he added.

“But when it comes to putting these tests together, the real question will be what tests are you going to offer, and how are you going to decide if those tests are appropriate?” he said.

Whether physicians want them or not, at-home genetic tests are out there. Many of the tests available are for fertility- or gynecologic-related conditions.

One company, San Francisco-based DNA Direct, offers tests for BRCA mutations, thrombophilia, hemochromatosis, cystic fibrosis, and α₁-antitrypsin deficiency. Prices for the tests range from $199 to $3,311 and include a “personalized report” of the results and phone consultation with a genetic expert.

Many of the tests are done with a cheek swab; the sample is sent through the mail.

For tests that require a blood sample, the customer is directed to a federally certified lab that collects the sample and then ships it in the manner required, according to Ryan Phelan, DNA Direct's founder and CEO. In either case, the customer remains anonymous throughout the process.

Michael Mennuti, M.D., chair of the obstetrics and gynecology department at the Hospital of the University of Pennsylvania in Philadelphia, also expressed concerns.

For instance, “when you have laboratory tests available to patients who have a problem, and you report a normal result [on the first test], then the patient's next question is, 'Well, what is causing this problem, and what's the next test?'” said Dr. Mennuti, who is also president-elect of the American College of Obstetricians and Gynecologists. “Here you're communicating with someone who has an employer-employee relationship with the laboratory. There is a potential for a conflict of interest.”

Customers have several reasons for using at-home tests, Ms. Phelan said.

“One is access to a test that their physician did not know about, did not choose to offer, or did not recommend. Number two is to get it interpreted by experts who actually understand the nuances. And third is insurance discrimination or worry about insurance discrimination,” she explained.

Physicians' lack of genetic knowledge is a real issue, said R. Alta Charo, professor of law and medical ethics at the University of Wisconsin at Madison.

She noted that when she worked for the now-defunct Federal Office of Technology Assessment about 15 years ago, the office did a study on sperm donation and surveyed physicians about their choices of men they would allow to donate for their patients.

“We discovered a woeful lack of understanding of basic genetics,” she said.

“They would screen out perfectly healthy men who had first-degree relatives with hemophilia—apparently not recognizing that if they were healthy they couldn't have the hemophilia mutation—but would allow in men who had parents with Huntington's chorea and who were young enough not have presented [with symptoms].”

Although medical schools have since made great strides in these areas, “I would suspect that there is still a relative lack of sophisticated understanding of modern genetics prevalent among many physicians, and therefore they may not pick up the kind of things patients might have that would explain their symptoms,” Ms. Charo continued.

“One of the advantages [of at-home tests] is that people may detect something that may otherwise go overlooked,” she said.

Some panelists expressed concern at the lack of regulation of at-home genetic tests.

Gail Javitt, policy analyst at the Genetics and Public Policy Center, noted that state laws applying to at-home tests vary greatly.

“Some states require a health care provider to order a test and get the results back; other states don't require this,” Ms. Javitt pointed out. But “even when a provider's involvement is required, it does not necessarily have to be the patient's personal physician. It can be a provider associated with the company offering the test.”

As for the actual tests, there is little government oversight, she continued. “Most genetic tests are provided by clinical laboratories, and the laboratory director decides when to offer the tests and what tests to offer.

“Labs are subject to general quality standards, but these are not genetic test-specific. Of the more than 800 tests currently out there, only a handful are regulated by the [Food and Drug Administration]. Indeed, FDA provides more oversight for home pregnancy tests than it does today for most genetic tests,” she said.

Steve Gutman of the FDA's Office of In Vitro Diagnostics, who was in the audience, said that the FDA is “not disinterested” in this area.

The agency “is not unaware of very colorful array of forces that are operating here, and it does not have easy answers. The unanswered question is how the FDA might move from the small set of commercial tests it now regulates to broader regulation of building blocks of home-brewed tests or the home-brewed tests themselves.

“I can't make any promise about timelines, but I can make a promise that the last chapter hasn't been written. It's a novel in progress,” he noted

The Mental Health Parity Act of 1996 has resulted in some gains in employee mental health coverage, but inequities remain, according to a report from the U.S. Department of Labor.

Since passage of the act, which requires employers to equalize dollar benefits for mental health and physical health coverage, the incidence of employees in plans that impose more restrictive dollar limits on inpatient mental health care coverage has decreased from 41% in 1997 to 7% in 2002.

However, employees in plans that contain tighter restrictions on the number of days of inpatient mental health care compared with inpatient medical and surgical care—a disparity allowed under the law—rose from 61% to 77% in the same period.

Differences in substance abuse coverage also remained, with only 8% of employees who had coverage for alcoholism treatment receiving the same coverage for that condition as for other conditions in 2002.

The Mental Health Parity Act of 1996 has resulted in some gains in employee mental health coverage, but inequities remain, according to a report from the U.S. Department of Labor.

Since passage of the act, which requires employers to equalize dollar benefits for mental health and physical health coverage, the incidence of employees in plans that impose more restrictive dollar limits on inpatient mental health care coverage has decreased from 41% in 1997 to 7% in 2002.

However, employees in plans that contain tighter restrictions on the number of days of inpatient mental health care compared with inpatient medical and surgical care—a disparity allowed under the law—rose from 61% to 77% in the same period.

Differences in substance abuse coverage also remained, with only 8% of employees who had coverage for alcoholism treatment receiving the same coverage for that condition as for other conditions in 2002.

The Mental Health Parity Act of 1996 has resulted in some gains in employee mental health coverage, but inequities remain, according to a report from the U.S. Department of Labor.

Since passage of the act, which requires employers to equalize dollar benefits for mental health and physical health coverage, the incidence of employees in plans that impose more restrictive dollar limits on inpatient mental health care coverage has decreased from 41% in 1997 to 7% in 2002.

However, employees in plans that contain tighter restrictions on the number of days of inpatient mental health care compared with inpatient medical and surgical care—a disparity allowed under the law—rose from 61% to 77% in the same period.

Differences in substance abuse coverage also remained, with only 8% of employees who had coverage for alcoholism treatment receiving the same coverage for that condition as for other conditions in 2002.

When it comes to tort reform in Texas, physicians there say “so far, so good.”

In 2003, the state enacted a tort reform law similar to that of California, including a $250,000 cap on noneconomic damages. So far, that's been good news for Texas physicians, according to R. Moss Hampton, M.D., head of the Texas Association of Ob.Gyns.

“Everybody here would say it's been a success,” said Dr. Hampton, who practices in Amarillo. He noted that the Texas Medical Liability Trust, the state's largest medical malpractice insurer, has reduced its rates by 17% since the law went into effect.

“That's kind of set the tone for the state, and the state board of insurance is trying to get other carriers to do same thing, with some success,” he said.

“And a number of carriers are moving back into the state,” Dr. Hampton added.

However, “it's obviously early in the process,” Dr. Hampton cautioned. “Everyone told us to expect initially that claims would go down, and [the question is] how soon it would take to start going back up. … We've also seen bills in the legislature trying to erode some of the gains we made, but so far none [has] taken hold.”

Not everyone is pleased with the law. “I have no problems with my malpractice carrier, but this [law] is not the answer,” said Jerry Frankel, M.D., a urologist practicing in McKinney, Tex.

“The answer is to totally change the concept of malpractice,” Dr. Frankel said.

Instead of the current system, Dr. Frankel supports a no-fault liability system, in which injured patients are reimbursed based on a set formula. “The way the system works now, only a tiny percentage of people get compensation, and 70% of money goes to lawyers and the court system,” he said. “But if you leave the lawyers out and the courts out, 100% of compensation would go to victims of bad outcomes.”

Using caps to compensate patients who have been harmed is not a fair approach, Dr. Frankel said. “The trouble with caps is, we do have nightmares. One woman had a bilateral mastectomy, and she had benign disease. She got $100,000. If this had happened to my wife, a trillion dollars wouldn't be enough.”

To make sure that bad physicians are appropriately disciplined, Dr. Frankel said there should be a separate system to monitor them. “That would be much better than now, and once these doctors piled up enough points, there would be some sort of disciplinary action—retraining them, restricting their privileges, or having them lose their license.”

Dr. Frankel said the reason malpractice premiums had been going up does not appear to be related to lawsuits. “Maybe 1% of people who are injured get some kind of compensation, and nobody's shown that the number of injuries is growing or the number of bad doctors is increasing.” Instead, he said, “all that happens is when the stock market goes bad, premiums go up.”

Not so, according to Donald J. Zuk, president and CEO of SCPIE, a medical malpractice insurer that left the Texas market in 2002. “Insurers cannot raise premiums to cover past losses,” he said at a conference sponsored by the American Enterprise Institute in Washington. Rather, “premiums are tied to estimates of future paid losses.”

Mr. Zuk also noted that state insurance departments limit malpractice insurers in the amount of assets they can invest in the stock market. “Most companies, if they're going to do it, put in 10%–15%,” he said. “At SCPIE, we do 3%. You're not going to do [more] because you're not going to take the chance.”

Mr. Zuk said that his company left the Texas market because of losses from lawsuits. In 1999, for instance, the company's loss ratio in the state was 177%—it paid out 77% more in claims than it had taken in premiums. The loss ratio increased over the next 2 years to 228% in 2001; by 2004 it had dropped to 139%, still well over the amount it had taken in.

“The problem is not so much frequency as severity—that's where we're getting killed,” he noted.

Despite the new law, Mr. Zuk said his company has no plans to re-enter the Texas market. “We're out of Texas for the immediate future because it's just too dangerous.”

In the meantime, Dr. Hampton thinks that he might be seeing an upturn in the supply of ob.gyns. in the state of Texas. “In our area, we have not seen a big shift, but in Austin and some other metropolitan areas, we have seen the number of practicing ob.gyn. doctors increase,” he explained.

“I'd be reluctant to say that malpractice rates came down, and we've now got people rushing back in, but from an ob.gyn. standpoint, [tort reform has] made it more attractive to younger physicians to stay in the state rather than go somewhere else where rates are lower,” Dr. Hampton said.

When it comes to tort reform in Texas, physicians there say “so far, so good.”

In 2003, the state enacted a tort reform law similar to that of California, including a $250,000 cap on noneconomic damages. So far, that's been good news for Texas physicians, according to R. Moss Hampton, M.D., head of the Texas Association of Ob.Gyns.

“Everybody here would say it's been a success,” said Dr. Hampton, who practices in Amarillo. He noted that the Texas Medical Liability Trust, the state's largest medical malpractice insurer, has reduced its rates by 17% since the law went into effect.

“That's kind of set the tone for the state, and the state board of insurance is trying to get other carriers to do same thing, with some success,” he said.

“And a number of carriers are moving back into the state,” Dr. Hampton added.

However, “it's obviously early in the process,” Dr. Hampton cautioned. “Everyone told us to expect initially that claims would go down, and [the question is] how soon it would take to start going back up. … We've also seen bills in the legislature trying to erode some of the gains we made, but so far none [has] taken hold.”

Not everyone is pleased with the law. “I have no problems with my malpractice carrier, but this [law] is not the answer,” said Jerry Frankel, M.D., a urologist practicing in McKinney, Tex.

“The answer is to totally change the concept of malpractice,” Dr. Frankel said.

Instead of the current system, Dr. Frankel supports a no-fault liability system, in which injured patients are reimbursed based on a set formula. “The way the system works now, only a tiny percentage of people get compensation, and 70% of money goes to lawyers and the court system,” he said. “But if you leave the lawyers out and the courts out, 100% of compensation would go to victims of bad outcomes.”

Using caps to compensate patients who have been harmed is not a fair approach, Dr. Frankel said. “The trouble with caps is, we do have nightmares. One woman had a bilateral mastectomy, and she had benign disease. She got $100,000. If this had happened to my wife, a trillion dollars wouldn't be enough.”

To make sure that bad physicians are appropriately disciplined, Dr. Frankel said there should be a separate system to monitor them. “That would be much better than now, and once these doctors piled up enough points, there would be some sort of disciplinary action—retraining them, restricting their privileges, or having them lose their license.”

Dr. Frankel said the reason malpractice premiums had been going up does not appear to be related to lawsuits. “Maybe 1% of people who are injured get some kind of compensation, and nobody's shown that the number of injuries is growing or the number of bad doctors is increasing.” Instead, he said, “all that happens is when the stock market goes bad, premiums go up.”

Not so, according to Donald J. Zuk, president and CEO of SCPIE, a medical malpractice insurer that left the Texas market in 2002. “Insurers cannot raise premiums to cover past losses,” he said at a conference sponsored by the American Enterprise Institute in Washington. Rather, “premiums are tied to estimates of future paid losses.”

Mr. Zuk also noted that state insurance departments limit malpractice insurers in the amount of assets they can invest in the stock market. “Most companies, if they're going to do it, put in 10%–15%,” he said. “At SCPIE, we do 3%. You're not going to do [more] because you're not going to take the chance.”

Mr. Zuk said that his company left the Texas market because of losses from lawsuits. In 1999, for instance, the company's loss ratio in the state was 177%—it paid out 77% more in claims than it had taken in premiums. The loss ratio increased over the next 2 years to 228% in 2001; by 2004 it had dropped to 139%, still well over the amount it had taken in.

“The problem is not so much frequency as severity—that's where we're getting killed,” he noted.

Despite the new law, Mr. Zuk said his company has no plans to re-enter the Texas market. “We're out of Texas for the immediate future because it's just too dangerous.”

In the meantime, Dr. Hampton thinks that he might be seeing an upturn in the supply of ob.gyns. in the state of Texas. “In our area, we have not seen a big shift, but in Austin and some other metropolitan areas, we have seen the number of practicing ob.gyn. doctors increase,” he explained.

“I'd be reluctant to say that malpractice rates came down, and we've now got people rushing back in, but from an ob.gyn. standpoint, [tort reform has] made it more attractive to younger physicians to stay in the state rather than go somewhere else where rates are lower,” Dr. Hampton said.

When it comes to tort reform in Texas, physicians there say “so far, so good.”

In 2003, the state enacted a tort reform law similar to that of California, including a $250,000 cap on noneconomic damages. So far, that's been good news for Texas physicians, according to R. Moss Hampton, M.D., head of the Texas Association of Ob.Gyns.

“Everybody here would say it's been a success,” said Dr. Hampton, who practices in Amarillo. He noted that the Texas Medical Liability Trust, the state's largest medical malpractice insurer, has reduced its rates by 17% since the law went into effect.

“That's kind of set the tone for the state, and the state board of insurance is trying to get other carriers to do same thing, with some success,” he said.

“And a number of carriers are moving back into the state,” Dr. Hampton added.

However, “it's obviously early in the process,” Dr. Hampton cautioned. “Everyone told us to expect initially that claims would go down, and [the question is] how soon it would take to start going back up. … We've also seen bills in the legislature trying to erode some of the gains we made, but so far none [has] taken hold.”

Not everyone is pleased with the law. “I have no problems with my malpractice carrier, but this [law] is not the answer,” said Jerry Frankel, M.D., a urologist practicing in McKinney, Tex.

“The answer is to totally change the concept of malpractice,” Dr. Frankel said.

Instead of the current system, Dr. Frankel supports a no-fault liability system, in which injured patients are reimbursed based on a set formula. “The way the system works now, only a tiny percentage of people get compensation, and 70% of money goes to lawyers and the court system,” he said. “But if you leave the lawyers out and the courts out, 100% of compensation would go to victims of bad outcomes.”

Using caps to compensate patients who have been harmed is not a fair approach, Dr. Frankel said. “The trouble with caps is, we do have nightmares. One woman had a bilateral mastectomy, and she had benign disease. She got $100,000. If this had happened to my wife, a trillion dollars wouldn't be enough.”

To make sure that bad physicians are appropriately disciplined, Dr. Frankel said there should be a separate system to monitor them. “That would be much better than now, and once these doctors piled up enough points, there would be some sort of disciplinary action—retraining them, restricting their privileges, or having them lose their license.”

Dr. Frankel said the reason malpractice premiums had been going up does not appear to be related to lawsuits. “Maybe 1% of people who are injured get some kind of compensation, and nobody's shown that the number of injuries is growing or the number of bad doctors is increasing.” Instead, he said, “all that happens is when the stock market goes bad, premiums go up.”

Not so, according to Donald J. Zuk, president and CEO of SCPIE, a medical malpractice insurer that left the Texas market in 2002. “Insurers cannot raise premiums to cover past losses,” he said at a conference sponsored by the American Enterprise Institute in Washington. Rather, “premiums are tied to estimates of future paid losses.”

Mr. Zuk also noted that state insurance departments limit malpractice insurers in the amount of assets they can invest in the stock market. “Most companies, if they're going to do it, put in 10%–15%,” he said. “At SCPIE, we do 3%. You're not going to do [more] because you're not going to take the chance.”

Mr. Zuk said that his company left the Texas market because of losses from lawsuits. In 1999, for instance, the company's loss ratio in the state was 177%—it paid out 77% more in claims than it had taken in premiums. The loss ratio increased over the next 2 years to 228% in 2001; by 2004 it had dropped to 139%, still well over the amount it had taken in.

“The problem is not so much frequency as severity—that's where we're getting killed,” he noted.

Despite the new law, Mr. Zuk said his company has no plans to re-enter the Texas market. “We're out of Texas for the immediate future because it's just too dangerous.”

In the meantime, Dr. Hampton thinks that he might be seeing an upturn in the supply of ob.gyns. in the state of Texas. “In our area, we have not seen a big shift, but in Austin and some other metropolitan areas, we have seen the number of practicing ob.gyn. doctors increase,” he explained.

“I'd be reluctant to say that malpractice rates came down, and we've now got people rushing back in, but from an ob.gyn. standpoint, [tort reform has] made it more attractive to younger physicians to stay in the state rather than go somewhere else where rates are lower,” Dr. Hampton said.

AAN Highlights Advance Directives

In the wake of the Terry Schiavo case, the American Academy of Neurology has added information on advance directives to its Web site. “When the Schiavo situation heated up, our president said, 'Why don't we have information about advance directives on our Web site?'” said AAN general counsel Murray Sagszveen. “It was a blinding flash of the obvious.” The site links users to an advance directives tool kit from the American Bar Association site as well as to a site run by the Robert Wood Johnson Foundation that includes information for all 50 states. Neurologists have a special interest in advance directives because “in other specialties, the patient will come in and may be repaired and go home,” Mr. Sagszveen said. “But with neurological diseases, they are all chronic and some are terminal illnesses. So I think neurologists have more interest than others in advance directives.”

New Medicare Wheelchair Policy

Ability to function is the primary criterion in Medicare's new national coverage policy for power wheelchairs and scooters. The criteria look at how well the beneficiary can accomplish activities of daily living such as toileting, grooming, and eating with and without using a wheelchair or other mobility device. The criteria are “part of our efforts to ensure that seniors who need mobility help will get it promptly, and that we are paying appropriately for mobility assistive equipment,” Mark B. McClellan, M.D., administrator of the Centers for Medicare and Medicaid Services said in a statement. The coverage policy is one element in Medicare's year-old effort to improve the coverage, payment, and quality of suppliers for wheelchairs and scooters. That effort was launched after Medicare spending on mobility equipment rose to $1.2 billion annually. Not addressed in the new policy was which specialists will be allowed to prescribe the devices and whether they will need to see the patients face-to-face, two issues of special concern to neurologists (“'Face-to-Face' DME Prescribing Proposal Annoys Neurologists,” CLINICAL NEUROLOGY NEWS, March 2005, p. 33). “While CMS does require adequate documentation to establish that coverage conditions are met, the complexity of the issues indicates this is best addressed in an initiative separate from the [coverage decision],” the agency said in its coverage memo. “In addition, the issues pertaining to who is qualified to do the patient evaluation [are] beyond the scope of this [decision].”

Ads Influence Prescribing

Direct-to-consumer advertisements appear to have an impact on physician prescribing practices, a study by Richard L. Kravitz, M.D., of the University of California, Davis, found (JAMA 2005;293:1995–2002). A total of 152 family physicians and general internists from solo and group practices and health maintenance organizations participated in the study, which focused on advertising for prescription antidepressants. Standardized patients were randomly assigned to make 298 unannounced visits, presenting either with major depression or adjustment disorder with depressed mood. When the patients with depression made a general request for an antidepressant, only 3% of the physicians prescribed paroxetine (Paxil). However, when they asked for the prescription by name, 27% were given a prescription for Paxil. In addition, patients with adjustment disorder symptoms were more likely to receive a prescription for an antidepressant if they made a brand-specific request (55%) vs. a general request (39%).

CMS: Pay for Performance Works

Pay for performance is improving quality of care in hospitals, judging from preliminary findings of a 3-year demonstration project sponsored by the Centers for Medicare and Medicaid Services. The project tracks hospital performance on 34 measures of processes and outcomes of care for five common clinical conditions. Year 1 data from over 270 participating hospitals show that median quality scores improved in all of the clinical areas. For example, scores increased from 64% to 76% for patients with heart failure and from 70% to 80% for patients with pneumonia.

AAN Highlights Advance Directives

In the wake of the Terry Schiavo case, the American Academy of Neurology has added information on advance directives to its Web site. “When the Schiavo situation heated up, our president said, 'Why don't we have information about advance directives on our Web site?'” said AAN general counsel Murray Sagszveen. “It was a blinding flash of the obvious.” The site links users to an advance directives tool kit from the American Bar Association site as well as to a site run by the Robert Wood Johnson Foundation that includes information for all 50 states. Neurologists have a special interest in advance directives because “in other specialties, the patient will come in and may be repaired and go home,” Mr. Sagszveen said. “But with neurological diseases, they are all chronic and some are terminal illnesses. So I think neurologists have more interest than others in advance directives.”

New Medicare Wheelchair Policy

Ability to function is the primary criterion in Medicare's new national coverage policy for power wheelchairs and scooters. The criteria look at how well the beneficiary can accomplish activities of daily living such as toileting, grooming, and eating with and without using a wheelchair or other mobility device. The criteria are “part of our efforts to ensure that seniors who need mobility help will get it promptly, and that we are paying appropriately for mobility assistive equipment,” Mark B. McClellan, M.D., administrator of the Centers for Medicare and Medicaid Services said in a statement. The coverage policy is one element in Medicare's year-old effort to improve the coverage, payment, and quality of suppliers for wheelchairs and scooters. That effort was launched after Medicare spending on mobility equipment rose to $1.2 billion annually. Not addressed in the new policy was which specialists will be allowed to prescribe the devices and whether they will need to see the patients face-to-face, two issues of special concern to neurologists (“'Face-to-Face' DME Prescribing Proposal Annoys Neurologists,” CLINICAL NEUROLOGY NEWS, March 2005, p. 33). “While CMS does require adequate documentation to establish that coverage conditions are met, the complexity of the issues indicates this is best addressed in an initiative separate from the [coverage decision],” the agency said in its coverage memo. “In addition, the issues pertaining to who is qualified to do the patient evaluation [are] beyond the scope of this [decision].”

Ads Influence Prescribing

Direct-to-consumer advertisements appear to have an impact on physician prescribing practices, a study by Richard L. Kravitz, M.D., of the University of California, Davis, found (JAMA 2005;293:1995–2002). A total of 152 family physicians and general internists from solo and group practices and health maintenance organizations participated in the study, which focused on advertising for prescription antidepressants. Standardized patients were randomly assigned to make 298 unannounced visits, presenting either with major depression or adjustment disorder with depressed mood. When the patients with depression made a general request for an antidepressant, only 3% of the physicians prescribed paroxetine (Paxil). However, when they asked for the prescription by name, 27% were given a prescription for Paxil. In addition, patients with adjustment disorder symptoms were more likely to receive a prescription for an antidepressant if they made a brand-specific request (55%) vs. a general request (39%).

CMS: Pay for Performance Works

Pay for performance is improving quality of care in hospitals, judging from preliminary findings of a 3-year demonstration project sponsored by the Centers for Medicare and Medicaid Services. The project tracks hospital performance on 34 measures of processes and outcomes of care for five common clinical conditions. Year 1 data from over 270 participating hospitals show that median quality scores improved in all of the clinical areas. For example, scores increased from 64% to 76% for patients with heart failure and from 70% to 80% for patients with pneumonia.

AAN Highlights Advance Directives

In the wake of the Terry Schiavo case, the American Academy of Neurology has added information on advance directives to its Web site. “When the Schiavo situation heated up, our president said, 'Why don't we have information about advance directives on our Web site?'” said AAN general counsel Murray Sagszveen. “It was a blinding flash of the obvious.” The site links users to an advance directives tool kit from the American Bar Association site as well as to a site run by the Robert Wood Johnson Foundation that includes information for all 50 states. Neurologists have a special interest in advance directives because “in other specialties, the patient will come in and may be repaired and go home,” Mr. Sagszveen said. “But with neurological diseases, they are all chronic and some are terminal illnesses. So I think neurologists have more interest than others in advance directives.”

New Medicare Wheelchair Policy

Ability to function is the primary criterion in Medicare's new national coverage policy for power wheelchairs and scooters. The criteria look at how well the beneficiary can accomplish activities of daily living such as toileting, grooming, and eating with and without using a wheelchair or other mobility device. The criteria are “part of our efforts to ensure that seniors who need mobility help will get it promptly, and that we are paying appropriately for mobility assistive equipment,” Mark B. McClellan, M.D., administrator of the Centers for Medicare and Medicaid Services said in a statement. The coverage policy is one element in Medicare's year-old effort to improve the coverage, payment, and quality of suppliers for wheelchairs and scooters. That effort was launched after Medicare spending on mobility equipment rose to $1.2 billion annually. Not addressed in the new policy was which specialists will be allowed to prescribe the devices and whether they will need to see the patients face-to-face, two issues of special concern to neurologists (“'Face-to-Face' DME Prescribing Proposal Annoys Neurologists,” CLINICAL NEUROLOGY NEWS, March 2005, p. 33). “While CMS does require adequate documentation to establish that coverage conditions are met, the complexity of the issues indicates this is best addressed in an initiative separate from the [coverage decision],” the agency said in its coverage memo. “In addition, the issues pertaining to who is qualified to do the patient evaluation [are] beyond the scope of this [decision].”

Ads Influence Prescribing

Direct-to-consumer advertisements appear to have an impact on physician prescribing practices, a study by Richard L. Kravitz, M.D., of the University of California, Davis, found (JAMA 2005;293:1995–2002). A total of 152 family physicians and general internists from solo and group practices and health maintenance organizations participated in the study, which focused on advertising for prescription antidepressants. Standardized patients were randomly assigned to make 298 unannounced visits, presenting either with major depression or adjustment disorder with depressed mood. When the patients with depression made a general request for an antidepressant, only 3% of the physicians prescribed paroxetine (Paxil). However, when they asked for the prescription by name, 27% were given a prescription for Paxil. In addition, patients with adjustment disorder symptoms were more likely to receive a prescription for an antidepressant if they made a brand-specific request (55%) vs. a general request (39%).

CMS: Pay for Performance Works

Pay for performance is improving quality of care in hospitals, judging from preliminary findings of a 3-year demonstration project sponsored by the Centers for Medicare and Medicaid Services. The project tracks hospital performance on 34 measures of processes and outcomes of care for five common clinical conditions. Year 1 data from over 270 participating hospitals show that median quality scores improved in all of the clinical areas. For example, scores increased from 64% to 76% for patients with heart failure and from 70% to 80% for patients with pneumonia.

WASHINGTON – Sixty-year-old Janice Ramsey used to have something in common with other Deltona, Fla., residents–she was a small business owner who had health insurance. But 7 years ago, all that changed.

Ms. Ramsey's problems started when she switched health insurance plans. “I purchased a new individual plan because the old one was a little high,” she said at a press briefing sponsored by the American Diabetes Association and Georgetown University. “I had the plan for a year and a half, and then I went to use it.” She needed the coverage to help pay for some blood work, which revealed that she had type 2 diabetes.

Once the claims for the tests were submitted, the insurer took another look at Ms. Ramsey's policy. “The plan said I must have had diabetes before I took their coverage, and they dropped me,” she said. “I was out all the premiums I had [paid].”

She then found coverage through an association health plan–a plan that covers members of trade associations and other small groups. But after paying premiums on that plan for 18 months, she had trouble again.

“I found out that the policy I had bought was fraudulent,” she said. “I had to use it because [the doctors] thought I was having a heart attack, and I went in for a catheterization. They didn't pay a dime.”

She was stuck with $23,000 in bills, which she eventually paid back. The plan then went bankrupt, and “they were not licensed in Florida, so the insurance commissioner told me I didn't have a chance to get any money back,” she added.

Since then, Ms. Ramsey has tried to get other coverage, to no avail. “I've contacted a lot of companies, and the answer is the same, 'Sorry, we cannot help you; you have diabetes,'” she said. “They kind of just hang up on you, like you don't even count.” She is hoping that she can hang on for another 5 years, when she'll be eligible for Medicare.

Ms. Ramsey's case is not uncommon, according to Karen Pollitz, project director at the Georgetown University Health Policy Institute and lead author of a report analyzing 850 case studies of diabetes patients who have had problems obtaining or keeping adequate health care coverage. “Even before we began this report, there were studies providing evidence that people who have serious or chronic illnesses are disadvantaged in the insurance system in the U.S. today,” she said.

On average, about 2 million Americans lose their health insurance every month, Ms. Pollitz noted. “Some move right on to the next plan, some are uninsured for a month or two, and some are uninsured for a very long time before they manage to regain their coverage.”

However, the burden is not spread equally, since people in poor health are twice as likely to be without insurance for a lengthy spell as those in good health.

People with diabetes need coverage that meets the three A's: accessibility, affordability, and adequacy, she continued. “Most people's problems [were caused by] a transition in coverage; people had lost their prior coverage or were about to lose their coverage and had encountered obstacles or penalties that made it harder to move on to their next coverage.”

Ms. Pollitz and her colleagues attempted to resolve the patients' insurance problems, with little success. For example, 377 people who had lost their job-based coverage were eligible for coverage under the Consolidated Omnibus Budget Reconciliation Act of 1985 (COBRA), but after they saw what the premiums would be–much more expensive than the premiums they paid on their earlier policies–only 15 people were able to enroll.

Further, 87 people were eligible for individual coverage under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), but only 11 were able to buy the coverage. And 344 people lived in states that had high-risk pools to help the uninsured, but only 7 ended up enrolling.

As for Medicaid, although a “large number” of patients had very low incomes–less than $1,000 per month–only 6 ended up being able to enroll in Medicaid, she said.

State high-risk pools were a good example of coverage barriers, according to Ms. Pollitz. Some of the pools were not very accessible; many had waiting lists or were closed to new enrollments. In Florida, where Ms. Ramsey lives, the high-risk pool “has been closed to new enrollees for more than a decade,” she noted.

Affordability is another problem with high-risk pools, since the coverage always costs 50%–100% more than what a private individual insurance policy would cost. For example, in Illinois, premiums can range as high as $1,084 per month, she said. The plans also are age rated, so the costs can grow three to four times in size as beneficiaries approach age 65.

Adequacy is also an issue with high-risk pool policies, Ms. Pollitz said. “High-risk pools often exclude preexisting conditions, so the thing that makes you eligible in the first place is excluded for 6–12 months.” Some pools also have limits on coverage for prescription drugs and mental health care.

On the private insurance side, the high-deductible policies that are increasing in popularity “really hit people with diabetes,” she said, noting that supplies for diabetes patients, such as medications, test strips, and insulin can range from $350 to $800 per month, depending on whether the patient is experiencing complications. “Those costs really add up.”

The features of health insurance that hurt diabetes patients and others with chronic illnesses “were all adopted for reasons that were perfectly logical,” such as keeping insurance companies solvent, protecting insurers from adverse selection, or being able to offer cheaper premiums.

“But those [features] tended to have been adopted one change at a time, so it was hard to step back and take a look at the big picture,” Ms. Pollitz said.

She added that the perspective of chronically ill patients “is a very important one to adopt when looking at proposals to change the health insurance system, because if change won't make it better for people who are sick, then what's the point?”

The report is available at www.healthinsuranceinfo.net/diabetes_and_health_insurance.pdf

WASHINGTON – Sixty-year-old Janice Ramsey used to have something in common with other Deltona, Fla., residents–she was a small business owner who had health insurance. But 7 years ago, all that changed.

Ms. Ramsey's problems started when she switched health insurance plans. “I purchased a new individual plan because the old one was a little high,” she said at a press briefing sponsored by the American Diabetes Association and Georgetown University. “I had the plan for a year and a half, and then I went to use it.” She needed the coverage to help pay for some blood work, which revealed that she had type 2 diabetes.

Once the claims for the tests were submitted, the insurer took another look at Ms. Ramsey's policy. “The plan said I must have had diabetes before I took their coverage, and they dropped me,” she said. “I was out all the premiums I had [paid].”

She then found coverage through an association health plan–a plan that covers members of trade associations and other small groups. But after paying premiums on that plan for 18 months, she had trouble again.

“I found out that the policy I had bought was fraudulent,” she said. “I had to use it because [the doctors] thought I was having a heart attack, and I went in for a catheterization. They didn't pay a dime.”

She was stuck with $23,000 in bills, which she eventually paid back. The plan then went bankrupt, and “they were not licensed in Florida, so the insurance commissioner told me I didn't have a chance to get any money back,” she added.

Since then, Ms. Ramsey has tried to get other coverage, to no avail. “I've contacted a lot of companies, and the answer is the same, 'Sorry, we cannot help you; you have diabetes,'” she said. “They kind of just hang up on you, like you don't even count.” She is hoping that she can hang on for another 5 years, when she'll be eligible for Medicare.

Ms. Ramsey's case is not uncommon, according to Karen Pollitz, project director at the Georgetown University Health Policy Institute and lead author of a report analyzing 850 case studies of diabetes patients who have had problems obtaining or keeping adequate health care coverage. “Even before we began this report, there were studies providing evidence that people who have serious or chronic illnesses are disadvantaged in the insurance system in the U.S. today,” she said.

On average, about 2 million Americans lose their health insurance every month, Ms. Pollitz noted. “Some move right on to the next plan, some are uninsured for a month or two, and some are uninsured for a very long time before they manage to regain their coverage.”

However, the burden is not spread equally, since people in poor health are twice as likely to be without insurance for a lengthy spell as those in good health.

People with diabetes need coverage that meets the three A's: accessibility, affordability, and adequacy, she continued. “Most people's problems [were caused by] a transition in coverage; people had lost their prior coverage or were about to lose their coverage and had encountered obstacles or penalties that made it harder to move on to their next coverage.”

Ms. Pollitz and her colleagues attempted to resolve the patients' insurance problems, with little success. For example, 377 people who had lost their job-based coverage were eligible for coverage under the Consolidated Omnibus Budget Reconciliation Act of 1985 (COBRA), but after they saw what the premiums would be–much more expensive than the premiums they paid on their earlier policies–only 15 people were able to enroll.

Further, 87 people were eligible for individual coverage under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), but only 11 were able to buy the coverage. And 344 people lived in states that had high-risk pools to help the uninsured, but only 7 ended up enrolling.

As for Medicaid, although a “large number” of patients had very low incomes–less than $1,000 per month–only 6 ended up being able to enroll in Medicaid, she said.

State high-risk pools were a good example of coverage barriers, according to Ms. Pollitz. Some of the pools were not very accessible; many had waiting lists or were closed to new enrollments. In Florida, where Ms. Ramsey lives, the high-risk pool “has been closed to new enrollees for more than a decade,” she noted.

Affordability is another problem with high-risk pools, since the coverage always costs 50%–100% more than what a private individual insurance policy would cost. For example, in Illinois, premiums can range as high as $1,084 per month, she said. The plans also are age rated, so the costs can grow three to four times in size as beneficiaries approach age 65.

Adequacy is also an issue with high-risk pool policies, Ms. Pollitz said. “High-risk pools often exclude preexisting conditions, so the thing that makes you eligible in the first place is excluded for 6–12 months.” Some pools also have limits on coverage for prescription drugs and mental health care.

On the private insurance side, the high-deductible policies that are increasing in popularity “really hit people with diabetes,” she said, noting that supplies for diabetes patients, such as medications, test strips, and insulin can range from $350 to $800 per month, depending on whether the patient is experiencing complications. “Those costs really add up.”

The features of health insurance that hurt diabetes patients and others with chronic illnesses “were all adopted for reasons that were perfectly logical,” such as keeping insurance companies solvent, protecting insurers from adverse selection, or being able to offer cheaper premiums.

“But those [features] tended to have been adopted one change at a time, so it was hard to step back and take a look at the big picture,” Ms. Pollitz said.

She added that the perspective of chronically ill patients “is a very important one to adopt when looking at proposals to change the health insurance system, because if change won't make it better for people who are sick, then what's the point?”

The report is available at www.healthinsuranceinfo.net/diabetes_and_health_insurance.pdf

WASHINGTON – Sixty-year-old Janice Ramsey used to have something in common with other Deltona, Fla., residents–she was a small business owner who had health insurance. But 7 years ago, all that changed.

Ms. Ramsey's problems started when she switched health insurance plans. “I purchased a new individual plan because the old one was a little high,” she said at a press briefing sponsored by the American Diabetes Association and Georgetown University. “I had the plan for a year and a half, and then I went to use it.” She needed the coverage to help pay for some blood work, which revealed that she had type 2 diabetes.

Once the claims for the tests were submitted, the insurer took another look at Ms. Ramsey's policy. “The plan said I must have had diabetes before I took their coverage, and they dropped me,” she said. “I was out all the premiums I had [paid].”

She then found coverage through an association health plan–a plan that covers members of trade associations and other small groups. But after paying premiums on that plan for 18 months, she had trouble again.

“I found out that the policy I had bought was fraudulent,” she said. “I had to use it because [the doctors] thought I was having a heart attack, and I went in for a catheterization. They didn't pay a dime.”

She was stuck with $23,000 in bills, which she eventually paid back. The plan then went bankrupt, and “they were not licensed in Florida, so the insurance commissioner told me I didn't have a chance to get any money back,” she added.

Since then, Ms. Ramsey has tried to get other coverage, to no avail. “I've contacted a lot of companies, and the answer is the same, 'Sorry, we cannot help you; you have diabetes,'” she said. “They kind of just hang up on you, like you don't even count.” She is hoping that she can hang on for another 5 years, when she'll be eligible for Medicare.

Ms. Ramsey's case is not uncommon, according to Karen Pollitz, project director at the Georgetown University Health Policy Institute and lead author of a report analyzing 850 case studies of diabetes patients who have had problems obtaining or keeping adequate health care coverage. “Even before we began this report, there were studies providing evidence that people who have serious or chronic illnesses are disadvantaged in the insurance system in the U.S. today,” she said.

On average, about 2 million Americans lose their health insurance every month, Ms. Pollitz noted. “Some move right on to the next plan, some are uninsured for a month or two, and some are uninsured for a very long time before they manage to regain their coverage.”

However, the burden is not spread equally, since people in poor health are twice as likely to be without insurance for a lengthy spell as those in good health.

People with diabetes need coverage that meets the three A's: accessibility, affordability, and adequacy, she continued. “Most people's problems [were caused by] a transition in coverage; people had lost their prior coverage or were about to lose their coverage and had encountered obstacles or penalties that made it harder to move on to their next coverage.”

Ms. Pollitz and her colleagues attempted to resolve the patients' insurance problems, with little success. For example, 377 people who had lost their job-based coverage were eligible for coverage under the Consolidated Omnibus Budget Reconciliation Act of 1985 (COBRA), but after they saw what the premiums would be–much more expensive than the premiums they paid on their earlier policies–only 15 people were able to enroll.

Further, 87 people were eligible for individual coverage under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), but only 11 were able to buy the coverage. And 344 people lived in states that had high-risk pools to help the uninsured, but only 7 ended up enrolling.

As for Medicaid, although a “large number” of patients had very low incomes–less than $1,000 per month–only 6 ended up being able to enroll in Medicaid, she said.

State high-risk pools were a good example of coverage barriers, according to Ms. Pollitz. Some of the pools were not very accessible; many had waiting lists or were closed to new enrollments. In Florida, where Ms. Ramsey lives, the high-risk pool “has been closed to new enrollees for more than a decade,” she noted.

Affordability is another problem with high-risk pools, since the coverage always costs 50%–100% more than what a private individual insurance policy would cost. For example, in Illinois, premiums can range as high as $1,084 per month, she said. The plans also are age rated, so the costs can grow three to four times in size as beneficiaries approach age 65.

Adequacy is also an issue with high-risk pool policies, Ms. Pollitz said. “High-risk pools often exclude preexisting conditions, so the thing that makes you eligible in the first place is excluded for 6–12 months.” Some pools also have limits on coverage for prescription drugs and mental health care.

On the private insurance side, the high-deductible policies that are increasing in popularity “really hit people with diabetes,” she said, noting that supplies for diabetes patients, such as medications, test strips, and insulin can range from $350 to $800 per month, depending on whether the patient is experiencing complications. “Those costs really add up.”

The features of health insurance that hurt diabetes patients and others with chronic illnesses “were all adopted for reasons that were perfectly logical,” such as keeping insurance companies solvent, protecting insurers from adverse selection, or being able to offer cheaper premiums.

“But those [features] tended to have been adopted one change at a time, so it was hard to step back and take a look at the big picture,” Ms. Pollitz said.

She added that the perspective of chronically ill patients “is a very important one to adopt when looking at proposals to change the health insurance system, because if change won't make it better for people who are sick, then what's the point?”

The report is available at www.healthinsuranceinfo.net/diabetes_and_health_insurance.pdf

California psychiatrists are wondering whether prescribing will be next, now that newly issued state regulations allow psychologists in the state to have admitting privileges for psychiatric patients.

“This would be a prelude to that, if you want to think about it from the psychologists' perspective,” said Randall Hagar, director of government affairs at the California Psychiatric Association in Sacramento. “Getting this kind of privilege would be 'physiciandom' [so now they will say], 'In order to better treat our patients, we need to be able to handle the medication aspect of it. We're prevented from taking good care of our patients until we get this privilege.'”

Psychology groups, however, reject the notion that getting these regulations into place is a stepping-stone to prescribing. “The big difference between prescribing and the hospital practices at issue with these laws is that the activities being envisioned by these regulations are already within the scope of the psychologist's license,” said Russ Newman, Ph.D., executive director for professional practice at the American Psychological Association in Washington. “Prescribing is not; it would require a psychology licensure change.”

The regulations, which apply to patients at psychiatric hospitals as well as those in psychiatric wards of acute-care facilities, permit psychologists to admit patients, order therapy, ask for consultations, and approve ground and weekend privileges, said Charles Faltz, Ph.D., director of professional affairs at the California Psychological Association in Sacramento.

Dr. Faltz added that although such privileges may be very new to some psychologists, others have already been doing much of the admitting work themselves anyway. He said that before he began working for the association, he was on the full medical staff of a hospital and was admitting and managing patients. “The way it's done is in collaboration with a physician–usually with both the primary care physician and the psychiatrist who prescribes medications,” he said.

One of the issues in dispute with the California regulations–which were first promulgated in 1978 and finally issued in April–is the way in which they were approved. Instead of going through the usual regulatory process, which require public hearings, these regulations ended up going through the courts–with little public input.

“These particular regulations were made using Rule 100, which [means that] if the courts interpret a particular law and say 'This is what the law means,' the regulatory agencies have no particular ability to change it,” Dr. Faltz said. “So they can simply put those regulations through, and they don't have public hearings, because it isn't possible for the public to change the court's interpretation.”

But Mr. Hagar said the regulations were the result of three attempts by the psychologists to get the regulations put out without public notice or input. “This attempt succeeded, and we're having a hard time figuring that there's anything else but politics involved,” he said.

Earlier attempts involved getting the psychologists privileges to order and release seclusion and restraint treatments, Mr. Hagar continued. “This time, they got the seclusion and restraint orders and also got the ability to put someone in a hospital and release them, and also to transfer them.”

Mr. Hagar said psychologists should be forewarned that their liability rates might increase now that they have these additional privileges. But Dr. Faltz said psychologists were not concerned about such a possibility, because their experience to date with collaborative practice has proved otherwise.

“There have never been any instances where it was shown that … psychologists practicing in hospitals in this way have had increased liability for psychologists or hospitals,” he said. “In fact, when something goes wrong, all the practitioners involved with the patient are sued. So if a psychiatrist is managing the patient and has a psychologist consulting or doing testing, all involved are sued. It's equal opportunity.”

So far, 17 other states and the District of Columbia have these hospital privileging laws in addition to California, but psychologists are not expecting many more of them to be passed, Dr. Newman said.

California psychiatrists are wondering whether prescribing will be next, now that newly issued state regulations allow psychologists in the state to have admitting privileges for psychiatric patients.

“This would be a prelude to that, if you want to think about it from the psychologists' perspective,” said Randall Hagar, director of government affairs at the California Psychiatric Association in Sacramento. “Getting this kind of privilege would be 'physiciandom' [so now they will say], 'In order to better treat our patients, we need to be able to handle the medication aspect of it. We're prevented from taking good care of our patients until we get this privilege.'”

Psychology groups, however, reject the notion that getting these regulations into place is a stepping-stone to prescribing. “The big difference between prescribing and the hospital practices at issue with these laws is that the activities being envisioned by these regulations are already within the scope of the psychologist's license,” said Russ Newman, Ph.D., executive director for professional practice at the American Psychological Association in Washington. “Prescribing is not; it would require a psychology licensure change.”

The regulations, which apply to patients at psychiatric hospitals as well as those in psychiatric wards of acute-care facilities, permit psychologists to admit patients, order therapy, ask for consultations, and approve ground and weekend privileges, said Charles Faltz, Ph.D., director of professional affairs at the California Psychological Association in Sacramento.

Dr. Faltz added that although such privileges may be very new to some psychologists, others have already been doing much of the admitting work themselves anyway. He said that before he began working for the association, he was on the full medical staff of a hospital and was admitting and managing patients. “The way it's done is in collaboration with a physician–usually with both the primary care physician and the psychiatrist who prescribes medications,” he said.

One of the issues in dispute with the California regulations–which were first promulgated in 1978 and finally issued in April–is the way in which they were approved. Instead of going through the usual regulatory process, which require public hearings, these regulations ended up going through the courts–with little public input.

“These particular regulations were made using Rule 100, which [means that] if the courts interpret a particular law and say 'This is what the law means,' the regulatory agencies have no particular ability to change it,” Dr. Faltz said. “So they can simply put those regulations through, and they don't have public hearings, because it isn't possible for the public to change the court's interpretation.”

But Mr. Hagar said the regulations were the result of three attempts by the psychologists to get the regulations put out without public notice or input. “This attempt succeeded, and we're having a hard time figuring that there's anything else but politics involved,” he said.

Earlier attempts involved getting the psychologists privileges to order and release seclusion and restraint treatments, Mr. Hagar continued. “This time, they got the seclusion and restraint orders and also got the ability to put someone in a hospital and release them, and also to transfer them.”

Mr. Hagar said psychologists should be forewarned that their liability rates might increase now that they have these additional privileges. But Dr. Faltz said psychologists were not concerned about such a possibility, because their experience to date with collaborative practice has proved otherwise.

“There have never been any instances where it was shown that … psychologists practicing in hospitals in this way have had increased liability for psychologists or hospitals,” he said. “In fact, when something goes wrong, all the practitioners involved with the patient are sued. So if a psychiatrist is managing the patient and has a psychologist consulting or doing testing, all involved are sued. It's equal opportunity.”

So far, 17 other states and the District of Columbia have these hospital privileging laws in addition to California, but psychologists are not expecting many more of them to be passed, Dr. Newman said.

California psychiatrists are wondering whether prescribing will be next, now that newly issued state regulations allow psychologists in the state to have admitting privileges for psychiatric patients.

“This would be a prelude to that, if you want to think about it from the psychologists' perspective,” said Randall Hagar, director of government affairs at the California Psychiatric Association in Sacramento. “Getting this kind of privilege would be 'physiciandom' [so now they will say], 'In order to better treat our patients, we need to be able to handle the medication aspect of it. We're prevented from taking good care of our patients until we get this privilege.'”

Psychology groups, however, reject the notion that getting these regulations into place is a stepping-stone to prescribing. “The big difference between prescribing and the hospital practices at issue with these laws is that the activities being envisioned by these regulations are already within the scope of the psychologist's license,” said Russ Newman, Ph.D., executive director for professional practice at the American Psychological Association in Washington. “Prescribing is not; it would require a psychology licensure change.”

The regulations, which apply to patients at psychiatric hospitals as well as those in psychiatric wards of acute-care facilities, permit psychologists to admit patients, order therapy, ask for consultations, and approve ground and weekend privileges, said Charles Faltz, Ph.D., director of professional affairs at the California Psychological Association in Sacramento.

Dr. Faltz added that although such privileges may be very new to some psychologists, others have already been doing much of the admitting work themselves anyway. He said that before he began working for the association, he was on the full medical staff of a hospital and was admitting and managing patients. “The way it's done is in collaboration with a physician–usually with both the primary care physician and the psychiatrist who prescribes medications,” he said.

One of the issues in dispute with the California regulations–which were first promulgated in 1978 and finally issued in April–is the way in which they were approved. Instead of going through the usual regulatory process, which require public hearings, these regulations ended up going through the courts–with little public input.

“These particular regulations were made using Rule 100, which [means that] if the courts interpret a particular law and say 'This is what the law means,' the regulatory agencies have no particular ability to change it,” Dr. Faltz said. “So they can simply put those regulations through, and they don't have public hearings, because it isn't possible for the public to change the court's interpretation.”

But Mr. Hagar said the regulations were the result of three attempts by the psychologists to get the regulations put out without public notice or input. “This attempt succeeded, and we're having a hard time figuring that there's anything else but politics involved,” he said.

Earlier attempts involved getting the psychologists privileges to order and release seclusion and restraint treatments, Mr. Hagar continued. “This time, they got the seclusion and restraint orders and also got the ability to put someone in a hospital and release them, and also to transfer them.”

Mr. Hagar said psychologists should be forewarned that their liability rates might increase now that they have these additional privileges. But Dr. Faltz said psychologists were not concerned about such a possibility, because their experience to date with collaborative practice has proved otherwise.

“There have never been any instances where it was shown that … psychologists practicing in hospitals in this way have had increased liability for psychologists or hospitals,” he said. “In fact, when something goes wrong, all the practitioners involved with the patient are sued. So if a psychiatrist is managing the patient and has a psychologist consulting or doing testing, all involved are sued. It's equal opportunity.”

So far, 17 other states and the District of Columbia have these hospital privileging laws in addition to California, but psychologists are not expecting many more of them to be passed, Dr. Newman said.