Mary Ellen Schneider

As physicians push for professional liability reform at the national level, the Maryland legislature signed off on a bill aimed at halting rising malpractice premiums.

The centerpiece of the legislation is a rate stabilization fund for medical professional liability insurance that will be funded through a tax on HMOs.

The Maryland State Medical Society (MedChi) and the Maryland Hospital Association estimate that the fund would cover about 95% of the increase in premiums for 2005. Obstetricians in Maryland are paying about $120,000–$160,000 for insurance coverage this year.

Maryland physicians have been pushing hard for reform—especially since last fall, when the state's largest malpractice carrier, Medical Mutual of Maryland, said it would raise its premium rates in 2005 an average 33%. The move follows a 28% increase a year ago.

Maryland is considered a medical liability insurance crisis state by the American College of Obstetricians and Gynecologists. And physicians of all specialties in the state are choosing to lay off staff, close practices, or move, in order to deal with the malpractice problem, according to MedChi.

The new legislation was passed in dramatic fashion during an end-of-the-year special session called by Gov. Robert Ehrlich. But he objected to the HMO tax and said the bill didn't contain meaningful tort reform. He then vetoed the measure in January, but legislators returned to work to override the veto.

The saga is expected to continue as Mr. Ehrlich prepares to introduce other legislation with more comprehensive reforms.

The state's physician and hospital groups are applauding the new legislation as an important first step. “While we agree with the governor and others that Maryland needs more comprehensive reform, it does offer important positive elements that we cannot walk away from, given the need to assure access to health care to the citizens of Maryland,” MedChi and the Maryland Hospital Association said in a joint statement. “We believe this bill will keep physicians on the job.”

The groups pointed out that the measure contains a reduction in the cap on noneconomic damages in death cases, reform of how past medical expenses are calculated, and new requirements for expert witnesses. However, the legislation fails to include needed reforms such as mandatory structured settlements of awards, an expansion of the Good Samaritan Act to include emergency department professionals, and parameters on the calculation of future economic damages, the groups said.

Although there is still more work to be done, the attention brought to medical liability reform through the special session is good news for physicians, said Willarda V. Edwards, M.D., an internist in South Baltimore and MedChi president.

The increased awareness and the better understanding of the issues that resulted from the special session will help as physicians seek increased reform this year, she said. MedChi plans to pursue limits on lawyers' fees, structured settlements that can be paid over time, reforming the calculation of economic damage payments, and enactment of a Good Samaritan law.

“This is just a little taste of what we think should be done,” Dr. Edwards said.

But physicians in Maryland are still waiting to see what the current legislation will mean in terms of premiums. “It's too early to say how this is going work,” said Miriam Yudkoff, M.D., an ob.gyn. in Annapolis.

And Dr. Yudkoff said she has some concerns about what the insurance reform provisions in the legislation will mean for liability carriers. If Maryland becomes an unprofitable place for insurers, it could have a significant impact on physicians' ability to obtain coverage. “We need a bill that will make Maryland a favorable state for carriers,” she said.

Carol Ritter, M.D., a solo gynecologist in Towson, who gave up obstetrics last year, said she sees the legislation as a first step in reform. However, the changes prescribed by the legislation aren't enough to make her able to afford to practice obstetrics again.

The rate stabilization fund is likely to limit the 2005 average premium increase, Dr. Ritter said, but it will still be more than 2004 rates, which were already more than she could afford. However, Dr. Ritter said she's hopeful that it will allow some of her colleagues to stay in practice in the short term.

The legislation also won't help David Zisow, M.D., a gynecologist in Bel Air, to start practicing obstetrics again. Like Dr. Ritter, Dr. Zisow gave up obstetrics at the beginning of 2004 when the rates became too high. But even though the new legislation contains significant reforms, Dr. Zisow said he wouldn't be able to afford to buy the tail coverage that would be necessary to start practicing obstetrics again.

His insurer, Medical Mutual, allowed him to forego paying tail coverage for obstetrics because of his many years with the company. However, he would have to pay a significant amount if he were to go back into obstetrics, he said.

As it is, Dr. Zisow has already seen a major increase in his premiums for gynecology alone in 2005, and he said he isn't optimistic that the legislation will result in too much change in premiums.

“It's business as usual,” he said.

This is a wake-up call to physicians to get politically active, said Mark Seigel, M.D., an ob.gyn. in Gaithersburg and the former president of MedChi. Passing meaningful changes to the system takes time, he said, and ultimately it may mean voting officials out of office who fail to take on medical liability reform. “Doctors have to do more than just go to the office and see patients,” Dr. Seigel said.

As physicians push for professional liability reform at the national level, the Maryland legislature signed off on a bill aimed at halting rising malpractice premiums.

The centerpiece of the legislation is a rate stabilization fund for medical professional liability insurance that will be funded through a tax on HMOs.

The Maryland State Medical Society (MedChi) and the Maryland Hospital Association estimate that the fund would cover about 95% of the increase in premiums for 2005. Obstetricians in Maryland are paying about $120,000–$160,000 for insurance coverage this year.

Maryland physicians have been pushing hard for reform—especially since last fall, when the state's largest malpractice carrier, Medical Mutual of Maryland, said it would raise its premium rates in 2005 an average 33%. The move follows a 28% increase a year ago.

Maryland is considered a medical liability insurance crisis state by the American College of Obstetricians and Gynecologists. And physicians of all specialties in the state are choosing to lay off staff, close practices, or move, in order to deal with the malpractice problem, according to MedChi.

The new legislation was passed in dramatic fashion during an end-of-the-year special session called by Gov. Robert Ehrlich. But he objected to the HMO tax and said the bill didn't contain meaningful tort reform. He then vetoed the measure in January, but legislators returned to work to override the veto.

The saga is expected to continue as Mr. Ehrlich prepares to introduce other legislation with more comprehensive reforms.

The state's physician and hospital groups are applauding the new legislation as an important first step. “While we agree with the governor and others that Maryland needs more comprehensive reform, it does offer important positive elements that we cannot walk away from, given the need to assure access to health care to the citizens of Maryland,” MedChi and the Maryland Hospital Association said in a joint statement. “We believe this bill will keep physicians on the job.”

The groups pointed out that the measure contains a reduction in the cap on noneconomic damages in death cases, reform of how past medical expenses are calculated, and new requirements for expert witnesses. However, the legislation fails to include needed reforms such as mandatory structured settlements of awards, an expansion of the Good Samaritan Act to include emergency department professionals, and parameters on the calculation of future economic damages, the groups said.

Although there is still more work to be done, the attention brought to medical liability reform through the special session is good news for physicians, said Willarda V. Edwards, M.D., an internist in South Baltimore and MedChi president.

The increased awareness and the better understanding of the issues that resulted from the special session will help as physicians seek increased reform this year, she said. MedChi plans to pursue limits on lawyers' fees, structured settlements that can be paid over time, reforming the calculation of economic damage payments, and enactment of a Good Samaritan law.

“This is just a little taste of what we think should be done,” Dr. Edwards said.

But physicians in Maryland are still waiting to see what the current legislation will mean in terms of premiums. “It's too early to say how this is going work,” said Miriam Yudkoff, M.D., an ob.gyn. in Annapolis.

And Dr. Yudkoff said she has some concerns about what the insurance reform provisions in the legislation will mean for liability carriers. If Maryland becomes an unprofitable place for insurers, it could have a significant impact on physicians' ability to obtain coverage. “We need a bill that will make Maryland a favorable state for carriers,” she said.

Carol Ritter, M.D., a solo gynecologist in Towson, who gave up obstetrics last year, said she sees the legislation as a first step in reform. However, the changes prescribed by the legislation aren't enough to make her able to afford to practice obstetrics again.

The rate stabilization fund is likely to limit the 2005 average premium increase, Dr. Ritter said, but it will still be more than 2004 rates, which were already more than she could afford. However, Dr. Ritter said she's hopeful that it will allow some of her colleagues to stay in practice in the short term.

The legislation also won't help David Zisow, M.D., a gynecologist in Bel Air, to start practicing obstetrics again. Like Dr. Ritter, Dr. Zisow gave up obstetrics at the beginning of 2004 when the rates became too high. But even though the new legislation contains significant reforms, Dr. Zisow said he wouldn't be able to afford to buy the tail coverage that would be necessary to start practicing obstetrics again.

His insurer, Medical Mutual, allowed him to forego paying tail coverage for obstetrics because of his many years with the company. However, he would have to pay a significant amount if he were to go back into obstetrics, he said.

As it is, Dr. Zisow has already seen a major increase in his premiums for gynecology alone in 2005, and he said he isn't optimistic that the legislation will result in too much change in premiums.

“It's business as usual,” he said.

This is a wake-up call to physicians to get politically active, said Mark Seigel, M.D., an ob.gyn. in Gaithersburg and the former president of MedChi. Passing meaningful changes to the system takes time, he said, and ultimately it may mean voting officials out of office who fail to take on medical liability reform. “Doctors have to do more than just go to the office and see patients,” Dr. Seigel said.

As physicians push for professional liability reform at the national level, the Maryland legislature signed off on a bill aimed at halting rising malpractice premiums.

The centerpiece of the legislation is a rate stabilization fund for medical professional liability insurance that will be funded through a tax on HMOs.

The Maryland State Medical Society (MedChi) and the Maryland Hospital Association estimate that the fund would cover about 95% of the increase in premiums for 2005. Obstetricians in Maryland are paying about $120,000–$160,000 for insurance coverage this year.

Maryland physicians have been pushing hard for reform—especially since last fall, when the state's largest malpractice carrier, Medical Mutual of Maryland, said it would raise its premium rates in 2005 an average 33%. The move follows a 28% increase a year ago.

Maryland is considered a medical liability insurance crisis state by the American College of Obstetricians and Gynecologists. And physicians of all specialties in the state are choosing to lay off staff, close practices, or move, in order to deal with the malpractice problem, according to MedChi.

The new legislation was passed in dramatic fashion during an end-of-the-year special session called by Gov. Robert Ehrlich. But he objected to the HMO tax and said the bill didn't contain meaningful tort reform. He then vetoed the measure in January, but legislators returned to work to override the veto.

The saga is expected to continue as Mr. Ehrlich prepares to introduce other legislation with more comprehensive reforms.

The state's physician and hospital groups are applauding the new legislation as an important first step. “While we agree with the governor and others that Maryland needs more comprehensive reform, it does offer important positive elements that we cannot walk away from, given the need to assure access to health care to the citizens of Maryland,” MedChi and the Maryland Hospital Association said in a joint statement. “We believe this bill will keep physicians on the job.”

The groups pointed out that the measure contains a reduction in the cap on noneconomic damages in death cases, reform of how past medical expenses are calculated, and new requirements for expert witnesses. However, the legislation fails to include needed reforms such as mandatory structured settlements of awards, an expansion of the Good Samaritan Act to include emergency department professionals, and parameters on the calculation of future economic damages, the groups said.

Although there is still more work to be done, the attention brought to medical liability reform through the special session is good news for physicians, said Willarda V. Edwards, M.D., an internist in South Baltimore and MedChi president.

The increased awareness and the better understanding of the issues that resulted from the special session will help as physicians seek increased reform this year, she said. MedChi plans to pursue limits on lawyers' fees, structured settlements that can be paid over time, reforming the calculation of economic damage payments, and enactment of a Good Samaritan law.

“This is just a little taste of what we think should be done,” Dr. Edwards said.

But physicians in Maryland are still waiting to see what the current legislation will mean in terms of premiums. “It's too early to say how this is going work,” said Miriam Yudkoff, M.D., an ob.gyn. in Annapolis.

And Dr. Yudkoff said she has some concerns about what the insurance reform provisions in the legislation will mean for liability carriers. If Maryland becomes an unprofitable place for insurers, it could have a significant impact on physicians' ability to obtain coverage. “We need a bill that will make Maryland a favorable state for carriers,” she said.

Carol Ritter, M.D., a solo gynecologist in Towson, who gave up obstetrics last year, said she sees the legislation as a first step in reform. However, the changes prescribed by the legislation aren't enough to make her able to afford to practice obstetrics again.

The rate stabilization fund is likely to limit the 2005 average premium increase, Dr. Ritter said, but it will still be more than 2004 rates, which were already more than she could afford. However, Dr. Ritter said she's hopeful that it will allow some of her colleagues to stay in practice in the short term.

The legislation also won't help David Zisow, M.D., a gynecologist in Bel Air, to start practicing obstetrics again. Like Dr. Ritter, Dr. Zisow gave up obstetrics at the beginning of 2004 when the rates became too high. But even though the new legislation contains significant reforms, Dr. Zisow said he wouldn't be able to afford to buy the tail coverage that would be necessary to start practicing obstetrics again.

His insurer, Medical Mutual, allowed him to forego paying tail coverage for obstetrics because of his many years with the company. However, he would have to pay a significant amount if he were to go back into obstetrics, he said.

As it is, Dr. Zisow has already seen a major increase in his premiums for gynecology alone in 2005, and he said he isn't optimistic that the legislation will result in too much change in premiums.

“It's business as usual,” he said.

This is a wake-up call to physicians to get politically active, said Mark Seigel, M.D., an ob.gyn. in Gaithersburg and the former president of MedChi. Passing meaningful changes to the system takes time, he said, and ultimately it may mean voting officials out of office who fail to take on medical liability reform. “Doctors have to do more than just go to the office and see patients,” Dr. Seigel said.

A limited, commercial program that would import drugs from Canada is feasible but would result in limited savings for consumers, members of a government task force on drug importation said at a press briefing sponsored by the Health and Human Services Department.

The HHS-convened task force dismissed the idea of personal importation of drugs from other countries as extraordinarily difficult and costly to implement safely.

It could cost as much as $3 billion a year to regulate personal importation, according to a letter sent to congressional leaders from the secretaries of HHS and the Commerce Department.

“Any plan to permit importation must be limited to commercial importation of a discrete number of high-volume, high-cost prescription drugs from a country with equivalent drug safety protections,” according to the secretaries. “These drugs must have the same level of safety and effectiveness as FDA-approved products.”

In the letter, Bush administration officials outlined the requirements of such a system: It should require drug pedigrees, limit ports of entry and distribution channels, and allow commercial importation only from licensed foreign wholesalers to authorized sellers in the United States.

A commercial program would have to be limited to those prescription drugs that are most likely to yield savings, such as a high-volume drug without a U.S.-approved generic. The administration is also asking Congress to exclude drugs or classes of drugs that could increase safety risks in an importation program, such as controlled substances or drugs that require refrigeration. And the program must avoid “anticompetitive provisions” including “forced sale” clauses and other types of price controls.

The letter also warns Congress that if its members pass legislation that stifles competition or fails to address safety concerns, the president's senior advisors will recommend a veto.

None of the legislation previously introduced in Congress would meet these criteria since most of it deals with personal importation of drugs, a senior administration official said in a teleconference announcing the release of the report.

The American Medical Association recently took a similar position on drug importation. The group said it supports importation of prescription drugs by wholesalers and pharmacies, if the drugs have been FDA approved and are part of a closed distribution chain. AMA does not support personal importation via the Internet until patient safety can be assured.

“Patient safety must remain the overriding concern as we work to make prescription drugs more available and affordable for patients. Patients must be protected from unapproved drugs that could be unsafe, expired, counterfeit, adulterated, misbranded, or inappropriately labeled,” AMA Trustee Edward L. Langston, M.D., said in a statement.

But Sen. Byron Dorgan (D-N.D.), a leading proponent of the importation of drugs from other countries, said he never had much confidence that the HHS study would be objective and plans to introduce reimportation legislation. “Millions of American obtain prescription medicines from Canada and other countries every year and do so safety,” Sen. Dorgan said in a statement. “The federal government itself is buying flu vaccine from abroad right now. The only thing endangered by allowing Americans access to lower priced FDA-approved medicines from abroad is the incredibly large profits of the drug companies who overprice their medicines in our market, just because they can.”

The HHS task force was formed early in 2004 to address questions posed by Congress in the Medicare Modernization Act. The law includes a provision that would allow the importation of prescription drugs from Canada if the HHS secretary certifies that the drugs pose no additional risk to public health and safety and would offer significant savings to U.S. consumers.

The HHS Task Force report on prescription drug importation is available online at www.hhs.gov/importtaskforce

A limited, commercial program that would import drugs from Canada is feasible but would result in limited savings for consumers, members of a government task force on drug importation said at a press briefing sponsored by the Health and Human Services Department.

The HHS-convened task force dismissed the idea of personal importation of drugs from other countries as extraordinarily difficult and costly to implement safely.

It could cost as much as $3 billion a year to regulate personal importation, according to a letter sent to congressional leaders from the secretaries of HHS and the Commerce Department.

“Any plan to permit importation must be limited to commercial importation of a discrete number of high-volume, high-cost prescription drugs from a country with equivalent drug safety protections,” according to the secretaries. “These drugs must have the same level of safety and effectiveness as FDA-approved products.”

In the letter, Bush administration officials outlined the requirements of such a system: It should require drug pedigrees, limit ports of entry and distribution channels, and allow commercial importation only from licensed foreign wholesalers to authorized sellers in the United States.

A commercial program would have to be limited to those prescription drugs that are most likely to yield savings, such as a high-volume drug without a U.S.-approved generic. The administration is also asking Congress to exclude drugs or classes of drugs that could increase safety risks in an importation program, such as controlled substances or drugs that require refrigeration. And the program must avoid “anticompetitive provisions” including “forced sale” clauses and other types of price controls.

The letter also warns Congress that if its members pass legislation that stifles competition or fails to address safety concerns, the president's senior advisors will recommend a veto.

None of the legislation previously introduced in Congress would meet these criteria since most of it deals with personal importation of drugs, a senior administration official said in a teleconference announcing the release of the report.

The American Medical Association recently took a similar position on drug importation. The group said it supports importation of prescription drugs by wholesalers and pharmacies, if the drugs have been FDA approved and are part of a closed distribution chain. AMA does not support personal importation via the Internet until patient safety can be assured.

“Patient safety must remain the overriding concern as we work to make prescription drugs more available and affordable for patients. Patients must be protected from unapproved drugs that could be unsafe, expired, counterfeit, adulterated, misbranded, or inappropriately labeled,” AMA Trustee Edward L. Langston, M.D., said in a statement.

But Sen. Byron Dorgan (D-N.D.), a leading proponent of the importation of drugs from other countries, said he never had much confidence that the HHS study would be objective and plans to introduce reimportation legislation. “Millions of American obtain prescription medicines from Canada and other countries every year and do so safety,” Sen. Dorgan said in a statement. “The federal government itself is buying flu vaccine from abroad right now. The only thing endangered by allowing Americans access to lower priced FDA-approved medicines from abroad is the incredibly large profits of the drug companies who overprice their medicines in our market, just because they can.”

The HHS task force was formed early in 2004 to address questions posed by Congress in the Medicare Modernization Act. The law includes a provision that would allow the importation of prescription drugs from Canada if the HHS secretary certifies that the drugs pose no additional risk to public health and safety and would offer significant savings to U.S. consumers.

The HHS Task Force report on prescription drug importation is available online at www.hhs.gov/importtaskforce

A limited, commercial program that would import drugs from Canada is feasible but would result in limited savings for consumers, members of a government task force on drug importation said at a press briefing sponsored by the Health and Human Services Department.

The HHS-convened task force dismissed the idea of personal importation of drugs from other countries as extraordinarily difficult and costly to implement safely.

It could cost as much as $3 billion a year to regulate personal importation, according to a letter sent to congressional leaders from the secretaries of HHS and the Commerce Department.

“Any plan to permit importation must be limited to commercial importation of a discrete number of high-volume, high-cost prescription drugs from a country with equivalent drug safety protections,” according to the secretaries. “These drugs must have the same level of safety and effectiveness as FDA-approved products.”

In the letter, Bush administration officials outlined the requirements of such a system: It should require drug pedigrees, limit ports of entry and distribution channels, and allow commercial importation only from licensed foreign wholesalers to authorized sellers in the United States.

A commercial program would have to be limited to those prescription drugs that are most likely to yield savings, such as a high-volume drug without a U.S.-approved generic. The administration is also asking Congress to exclude drugs or classes of drugs that could increase safety risks in an importation program, such as controlled substances or drugs that require refrigeration. And the program must avoid “anticompetitive provisions” including “forced sale” clauses and other types of price controls.

The letter also warns Congress that if its members pass legislation that stifles competition or fails to address safety concerns, the president's senior advisors will recommend a veto.

None of the legislation previously introduced in Congress would meet these criteria since most of it deals with personal importation of drugs, a senior administration official said in a teleconference announcing the release of the report.

The American Medical Association recently took a similar position on drug importation. The group said it supports importation of prescription drugs by wholesalers and pharmacies, if the drugs have been FDA approved and are part of a closed distribution chain. AMA does not support personal importation via the Internet until patient safety can be assured.

“Patient safety must remain the overriding concern as we work to make prescription drugs more available and affordable for patients. Patients must be protected from unapproved drugs that could be unsafe, expired, counterfeit, adulterated, misbranded, or inappropriately labeled,” AMA Trustee Edward L. Langston, M.D., said in a statement.

But Sen. Byron Dorgan (D-N.D.), a leading proponent of the importation of drugs from other countries, said he never had much confidence that the HHS study would be objective and plans to introduce reimportation legislation. “Millions of American obtain prescription medicines from Canada and other countries every year and do so safety,” Sen. Dorgan said in a statement. “The federal government itself is buying flu vaccine from abroad right now. The only thing endangered by allowing Americans access to lower priced FDA-approved medicines from abroad is the incredibly large profits of the drug companies who overprice their medicines in our market, just because they can.”

The HHS task force was formed early in 2004 to address questions posed by Congress in the Medicare Modernization Act. The law includes a provision that would allow the importation of prescription drugs from Canada if the HHS secretary certifies that the drugs pose no additional risk to public health and safety and would offer significant savings to U.S. consumers.

The HHS Task Force report on prescription drug importation is available online at www.hhs.gov/importtaskforce

WASHINGTON — The National Institutes of Health should increase its support for research into chronic fatigue syndrome in children to match the burden and impact of the illness, Peter Rowe, M.D., said at a meeting of the Health and Human Services Department's Chronic Fatigue Advisory Committee.

More philanthropic support is needed as well to advance the care of patients with chronic fatigue syndrome (CFS), said Dr. Rowe, a professor at Johns Hopkins Children's Center, Baltimore, and director of the center's chronic fatigue clinic.

Currently, just a few hospital or university-affiliated clinical centers are treating children with CFS. There are no training grants to attract new researchers, no university research centers, and only $1 million annually in NIH funds targeted at children with CFS.

“This isn't enough to create a critical level of interest in bringing good people into the field, and it does not make CFS seem like a viable option to the new pediatric researcher,” Dr. Rowe said.

As a result, it's difficult for CFS patients to find physicians to care for them, Dr. Rowe said. CFS specialists are usually overburdened, and when families can't find timely treatment, they sometimes resort to seeing physicians who charge high rates for an evaluation.

Dr. Rowe said he knows of one place where a patient can be evaluated fairly quickly—but at a price tag of $5,800. “I think we have a responsibility to protect children and young families from this kind of economic risk,” he said.

To be diagnosed with CFS, patients generally must have severe chronic fatigue for 6 months or longer with other known medical conditions excluded by clinical diagnosis, and they must concurrently have four or more of the following symptoms: substantial impairment in short-term memory or concentration; sore throat; tender lymph nodes; muscle pain; multijoint pain without swelling or redness; headaches of a new type, pattern, or severity; unrefreshing sleep; and postexertional malaise lasting more than 24 hours, according to the Centers for Disease Control and Prevention. The symptoms must have persisted or recurred during 6 or more consecutive months of illness and must not have predated the fatigue.

The heterogeneous nature of the illness itself makes it difficult to recognize and treat the disease, and it's difficult to control for just one variable in a randomized clinical trial on CFS because of the many overlapping and interacting pathophysiologic dysfunctions associated with the condition, he said.

Dr. Rowe proposes conducting randomized trials by withdrawing ostensibly effective therapies. For example, in an otherwise well-managed and clinically stable patient with CFS, the patient would be randomized to receive either a placebo or the active medication. Another option would be to incorporate a “run-in period” for studies during which other influences to symptoms are brought under good clinical control before examining the efficacy of a single agent.

WASHINGTON — The National Institutes of Health should increase its support for research into chronic fatigue syndrome in children to match the burden and impact of the illness, Peter Rowe, M.D., said at a meeting of the Health and Human Services Department's Chronic Fatigue Advisory Committee.

More philanthropic support is needed as well to advance the care of patients with chronic fatigue syndrome (CFS), said Dr. Rowe, a professor at Johns Hopkins Children's Center, Baltimore, and director of the center's chronic fatigue clinic.

Currently, just a few hospital or university-affiliated clinical centers are treating children with CFS. There are no training grants to attract new researchers, no university research centers, and only $1 million annually in NIH funds targeted at children with CFS.

“This isn't enough to create a critical level of interest in bringing good people into the field, and it does not make CFS seem like a viable option to the new pediatric researcher,” Dr. Rowe said.

As a result, it's difficult for CFS patients to find physicians to care for them, Dr. Rowe said. CFS specialists are usually overburdened, and when families can't find timely treatment, they sometimes resort to seeing physicians who charge high rates for an evaluation.

Dr. Rowe said he knows of one place where a patient can be evaluated fairly quickly—but at a price tag of $5,800. “I think we have a responsibility to protect children and young families from this kind of economic risk,” he said.

To be diagnosed with CFS, patients generally must have severe chronic fatigue for 6 months or longer with other known medical conditions excluded by clinical diagnosis, and they must concurrently have four or more of the following symptoms: substantial impairment in short-term memory or concentration; sore throat; tender lymph nodes; muscle pain; multijoint pain without swelling or redness; headaches of a new type, pattern, or severity; unrefreshing sleep; and postexertional malaise lasting more than 24 hours, according to the Centers for Disease Control and Prevention. The symptoms must have persisted or recurred during 6 or more consecutive months of illness and must not have predated the fatigue.

The heterogeneous nature of the illness itself makes it difficult to recognize and treat the disease, and it's difficult to control for just one variable in a randomized clinical trial on CFS because of the many overlapping and interacting pathophysiologic dysfunctions associated with the condition, he said.

Dr. Rowe proposes conducting randomized trials by withdrawing ostensibly effective therapies. For example, in an otherwise well-managed and clinically stable patient with CFS, the patient would be randomized to receive either a placebo or the active medication. Another option would be to incorporate a “run-in period” for studies during which other influences to symptoms are brought under good clinical control before examining the efficacy of a single agent.

WASHINGTON — The National Institutes of Health should increase its support for research into chronic fatigue syndrome in children to match the burden and impact of the illness, Peter Rowe, M.D., said at a meeting of the Health and Human Services Department's Chronic Fatigue Advisory Committee.

More philanthropic support is needed as well to advance the care of patients with chronic fatigue syndrome (CFS), said Dr. Rowe, a professor at Johns Hopkins Children's Center, Baltimore, and director of the center's chronic fatigue clinic.

Currently, just a few hospital or university-affiliated clinical centers are treating children with CFS. There are no training grants to attract new researchers, no university research centers, and only $1 million annually in NIH funds targeted at children with CFS.

“This isn't enough to create a critical level of interest in bringing good people into the field, and it does not make CFS seem like a viable option to the new pediatric researcher,” Dr. Rowe said.

As a result, it's difficult for CFS patients to find physicians to care for them, Dr. Rowe said. CFS specialists are usually overburdened, and when families can't find timely treatment, they sometimes resort to seeing physicians who charge high rates for an evaluation.

Dr. Rowe said he knows of one place where a patient can be evaluated fairly quickly—but at a price tag of $5,800. “I think we have a responsibility to protect children and young families from this kind of economic risk,” he said.

To be diagnosed with CFS, patients generally must have severe chronic fatigue for 6 months or longer with other known medical conditions excluded by clinical diagnosis, and they must concurrently have four or more of the following symptoms: substantial impairment in short-term memory or concentration; sore throat; tender lymph nodes; muscle pain; multijoint pain without swelling or redness; headaches of a new type, pattern, or severity; unrefreshing sleep; and postexertional malaise lasting more than 24 hours, according to the Centers for Disease Control and Prevention. The symptoms must have persisted or recurred during 6 or more consecutive months of illness and must not have predated the fatigue.

The heterogeneous nature of the illness itself makes it difficult to recognize and treat the disease, and it's difficult to control for just one variable in a randomized clinical trial on CFS because of the many overlapping and interacting pathophysiologic dysfunctions associated with the condition, he said.

Dr. Rowe proposes conducting randomized trials by withdrawing ostensibly effective therapies. For example, in an otherwise well-managed and clinically stable patient with CFS, the patient would be randomized to receive either a placebo or the active medication. Another option would be to incorporate a “run-in period” for studies during which other influences to symptoms are brought under good clinical control before examining the efficacy of a single agent.

Evaluating Disease Treatments

The Agency for Healthcare Research and Quality plans to spend $15 million this year to evaluate interventions and prescription drugs used by Medicare beneficiaries. AHRQ will consider interventions aimed at ischemic heart disease, cancer, chronic obstructive pulmonary disease and asthma, stroke, hypertension, arthritis and nontraumatic joint disorders, diabetes, dementia, peptic ulcer, and depression and mood disorders. AHRQ research will focus on the evidence of outcomes, and comparative clinical effectiveness and appropriateness. The results of these studies will be made available to Medicare, Medicaid, and the State Children's Health Insurance Program (SCHIP), as well as to private health plans, prescription drug plans, health care providers, and the public.

Carotid Stent Training Guidelines

A coalition of specialists, including interventional cardiologists, vascular surgeons, and vascular medicine physicians has released a clinical competence statement for determining when physicians are qualified to perform carotid artery stenting. The standards call for physicians to be proficient in other types of stenting, and then to perform a minimum of 30 diagnostic angiograms and 25 carotid stenting procedures under supervision before doing a carotid stenting alone. They also call for physicians to be skilled in risk assessment, diagnosis, and alternative therapies for the patients involved, and to report and analyze their outcomes. The document notes that physicians of many different subspecialties will seek the training; one issue in developing the guidelines had been whether to restrict training only to certain specialties. The statement is available at the Web site of the Society for Cardiovascular Angiography and Interventions, at

www.scai.org

Tenet Reaches Settlement

Tenet Healthcare Corp. recently announced an agreement to end a lawsuit with cardiac care patients from its Redding (Calif.) Medical Center. The patients had alleged that physicians had performed unnecessary cardiac catheterizations and bypass surgeries at the hospital prior to November 2002. Under the agreement, Tenet will establish a fund of $395 million to be allocated among more than 750 plaintiffs who had filed civil lawsuits. The settlement does not end litigation against the physicians at the facility. In August 2003, Tenet agreed to pay $54 million to settle federal and California government investigations of practices at the Redding facility. “We believe this settlement is the fair and honorable way to conclude this very sad chapter,” Tenet president and CEO Trevor Fetter said in a statement. “It would likely have taken multiple trials and many years to assess liability in these cases. By settling all the cases at once, we put this matter behind both the plaintiffs and us, and we bring closure to this unfortunate event.”

Computer Entries Lead to Errors

Automation isn't necessarily a foolproof way to improve patient safety and reduce medical errors, according to a report from the United States Pharmacopeia (USP). Computer entry errors were the fourth leading cause of medication errors according to MEDMARX, USP's national medication error reporting system. These errors have steadily increased and represent about 12% of all MEDMARX records from 1999 through 2003. Performance deficits—wherein an otherwise qualified physician makes a mistake—were the most frequently reported cause of errors. Distractions were the leading contributing factor, accounting for almost 57% of errors associated with computer entry. The report provided an analysis of 235,159 medication errors voluntarily reported by 570 hospitals and health care facilities nationwide.

Portable Health Plans

Patients can take their health insurance coverage with them when they change or lose a job, under the final regulations that implement the last piece of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). According to a statement by the Health and Human Services Department, it is important that American workers, who often change jobs several times in the course of their lives be able to respond to the modern workplace without having to fear for their health insurance. The regulations allow greater portability and availability of group health coverage during a time of job transition, setting limits on preexisting condition exclusions that could be imposed, and requiring group health plans and insurance issuers to offer “special enrollment” to certain patients who lose eligibility for other group health coverage or health insurance, or to otherwise eligible new dependents. The regulation goes into effect for plan years starting on or after July 1.

Evaluating Disease Treatments

The Agency for Healthcare Research and Quality plans to spend $15 million this year to evaluate interventions and prescription drugs used by Medicare beneficiaries. AHRQ will consider interventions aimed at ischemic heart disease, cancer, chronic obstructive pulmonary disease and asthma, stroke, hypertension, arthritis and nontraumatic joint disorders, diabetes, dementia, peptic ulcer, and depression and mood disorders. AHRQ research will focus on the evidence of outcomes, and comparative clinical effectiveness and appropriateness. The results of these studies will be made available to Medicare, Medicaid, and the State Children's Health Insurance Program (SCHIP), as well as to private health plans, prescription drug plans, health care providers, and the public.

Carotid Stent Training Guidelines

A coalition of specialists, including interventional cardiologists, vascular surgeons, and vascular medicine physicians has released a clinical competence statement for determining when physicians are qualified to perform carotid artery stenting. The standards call for physicians to be proficient in other types of stenting, and then to perform a minimum of 30 diagnostic angiograms and 25 carotid stenting procedures under supervision before doing a carotid stenting alone. They also call for physicians to be skilled in risk assessment, diagnosis, and alternative therapies for the patients involved, and to report and analyze their outcomes. The document notes that physicians of many different subspecialties will seek the training; one issue in developing the guidelines had been whether to restrict training only to certain specialties. The statement is available at the Web site of the Society for Cardiovascular Angiography and Interventions, at

www.scai.org

Tenet Reaches Settlement

Tenet Healthcare Corp. recently announced an agreement to end a lawsuit with cardiac care patients from its Redding (Calif.) Medical Center. The patients had alleged that physicians had performed unnecessary cardiac catheterizations and bypass surgeries at the hospital prior to November 2002. Under the agreement, Tenet will establish a fund of $395 million to be allocated among more than 750 plaintiffs who had filed civil lawsuits. The settlement does not end litigation against the physicians at the facility. In August 2003, Tenet agreed to pay $54 million to settle federal and California government investigations of practices at the Redding facility. “We believe this settlement is the fair and honorable way to conclude this very sad chapter,” Tenet president and CEO Trevor Fetter said in a statement. “It would likely have taken multiple trials and many years to assess liability in these cases. By settling all the cases at once, we put this matter behind both the plaintiffs and us, and we bring closure to this unfortunate event.”

Computer Entries Lead to Errors

Automation isn't necessarily a foolproof way to improve patient safety and reduce medical errors, according to a report from the United States Pharmacopeia (USP). Computer entry errors were the fourth leading cause of medication errors according to MEDMARX, USP's national medication error reporting system. These errors have steadily increased and represent about 12% of all MEDMARX records from 1999 through 2003. Performance deficits—wherein an otherwise qualified physician makes a mistake—were the most frequently reported cause of errors. Distractions were the leading contributing factor, accounting for almost 57% of errors associated with computer entry. The report provided an analysis of 235,159 medication errors voluntarily reported by 570 hospitals and health care facilities nationwide.

Portable Health Plans

Patients can take their health insurance coverage with them when they change or lose a job, under the final regulations that implement the last piece of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). According to a statement by the Health and Human Services Department, it is important that American workers, who often change jobs several times in the course of their lives be able to respond to the modern workplace without having to fear for their health insurance. The regulations allow greater portability and availability of group health coverage during a time of job transition, setting limits on preexisting condition exclusions that could be imposed, and requiring group health plans and insurance issuers to offer “special enrollment” to certain patients who lose eligibility for other group health coverage or health insurance, or to otherwise eligible new dependents. The regulation goes into effect for plan years starting on or after July 1.

Evaluating Disease Treatments

The Agency for Healthcare Research and Quality plans to spend $15 million this year to evaluate interventions and prescription drugs used by Medicare beneficiaries. AHRQ will consider interventions aimed at ischemic heart disease, cancer, chronic obstructive pulmonary disease and asthma, stroke, hypertension, arthritis and nontraumatic joint disorders, diabetes, dementia, peptic ulcer, and depression and mood disorders. AHRQ research will focus on the evidence of outcomes, and comparative clinical effectiveness and appropriateness. The results of these studies will be made available to Medicare, Medicaid, and the State Children's Health Insurance Program (SCHIP), as well as to private health plans, prescription drug plans, health care providers, and the public.

Carotid Stent Training Guidelines

A coalition of specialists, including interventional cardiologists, vascular surgeons, and vascular medicine physicians has released a clinical competence statement for determining when physicians are qualified to perform carotid artery stenting. The standards call for physicians to be proficient in other types of stenting, and then to perform a minimum of 30 diagnostic angiograms and 25 carotid stenting procedures under supervision before doing a carotid stenting alone. They also call for physicians to be skilled in risk assessment, diagnosis, and alternative therapies for the patients involved, and to report and analyze their outcomes. The document notes that physicians of many different subspecialties will seek the training; one issue in developing the guidelines had been whether to restrict training only to certain specialties. The statement is available at the Web site of the Society for Cardiovascular Angiography and Interventions, at

www.scai.org

Tenet Reaches Settlement

Tenet Healthcare Corp. recently announced an agreement to end a lawsuit with cardiac care patients from its Redding (Calif.) Medical Center. The patients had alleged that physicians had performed unnecessary cardiac catheterizations and bypass surgeries at the hospital prior to November 2002. Under the agreement, Tenet will establish a fund of $395 million to be allocated among more than 750 plaintiffs who had filed civil lawsuits. The settlement does not end litigation against the physicians at the facility. In August 2003, Tenet agreed to pay $54 million to settle federal and California government investigations of practices at the Redding facility. “We believe this settlement is the fair and honorable way to conclude this very sad chapter,” Tenet president and CEO Trevor Fetter said in a statement. “It would likely have taken multiple trials and many years to assess liability in these cases. By settling all the cases at once, we put this matter behind both the plaintiffs and us, and we bring closure to this unfortunate event.”

Computer Entries Lead to Errors

Automation isn't necessarily a foolproof way to improve patient safety and reduce medical errors, according to a report from the United States Pharmacopeia (USP). Computer entry errors were the fourth leading cause of medication errors according to MEDMARX, USP's national medication error reporting system. These errors have steadily increased and represent about 12% of all MEDMARX records from 1999 through 2003. Performance deficits—wherein an otherwise qualified physician makes a mistake—were the most frequently reported cause of errors. Distractions were the leading contributing factor, accounting for almost 57% of errors associated with computer entry. The report provided an analysis of 235,159 medication errors voluntarily reported by 570 hospitals and health care facilities nationwide.

Portable Health Plans

Patients can take their health insurance coverage with them when they change or lose a job, under the final regulations that implement the last piece of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). According to a statement by the Health and Human Services Department, it is important that American workers, who often change jobs several times in the course of their lives be able to respond to the modern workplace without having to fear for their health insurance. The regulations allow greater portability and availability of group health coverage during a time of job transition, setting limits on preexisting condition exclusions that could be imposed, and requiring group health plans and insurance issuers to offer “special enrollment” to certain patients who lose eligibility for other group health coverage or health insurance, or to otherwise eligible new dependents. The regulation goes into effect for plan years starting on or after July 1.

ALEXANDRIA, VA.—Traditional tort reform measures like damage caps won't address some of the fundamental problems with the medical liability system, experts said at a meeting on patient safety and medical liability sponsored by the Joint Commission on Accreditation of Healthcare Organizations.

To deal with the current malpractice situation, the medical community needs to address the reasons why people sue—injuries, unmet expenses, and anger, said Lucian L. Leape, M.D., of the department of health policy and management at the Harvard School of Public Health, Boston.

“The main reason most people sue is because they are angry at the physician,” Dr. Leape said.

But the current system and the most commonly proposed reforms, such as damage caps, don't address the need to increase disclosure of errors to patients or incentivize physicians to offer apologies, he said.

Traditional reform measures such as damage caps would undercompensate seriously injured patients and increase administrative costs, Michelle M. Mello, Ph.D., of Harvard School of Public Health, Boston, said. And they would not help deter medical malpractice.

Damage caps also fail to address the poor correlation between medical injury and malpractice claims, she said. Instead of focusing on caps, the medical community needs to consider an administrative compensation system to replace torts.

The medical malpractice system is “blocking efforts at patient safety,” said Troyen A. Brennan, M.D., professor of medicine at Harvard Medical School, Boston, and professor of law and public health at the Harvard School of Public Health. A new medical malpractice system should be established to separate compensation for injuries from deterrence, Dr. Brennan said.

For that to happen, liability for negligence has to be eliminated, and reporting has to be made based on injuries to the patient. “You have to enable open and honest reporting,” he added.

Physicians also have to realize that reporting patient injury is part of their professional responsibility, he said.

Currently, some physicians do not disclose medical errors or injuries. That may be a rational economic response to physicians' rising premiums and fear of facing a lawsuit, Dr. Brennan said, but it definitely is not an ethical response.

ALEXANDRIA, VA.—Traditional tort reform measures like damage caps won't address some of the fundamental problems with the medical liability system, experts said at a meeting on patient safety and medical liability sponsored by the Joint Commission on Accreditation of Healthcare Organizations.

To deal with the current malpractice situation, the medical community needs to address the reasons why people sue—injuries, unmet expenses, and anger, said Lucian L. Leape, M.D., of the department of health policy and management at the Harvard School of Public Health, Boston.

“The main reason most people sue is because they are angry at the physician,” Dr. Leape said.

But the current system and the most commonly proposed reforms, such as damage caps, don't address the need to increase disclosure of errors to patients or incentivize physicians to offer apologies, he said.

Traditional reform measures such as damage caps would undercompensate seriously injured patients and increase administrative costs, Michelle M. Mello, Ph.D., of Harvard School of Public Health, Boston, said. And they would not help deter medical malpractice.

Damage caps also fail to address the poor correlation between medical injury and malpractice claims, she said. Instead of focusing on caps, the medical community needs to consider an administrative compensation system to replace torts.

The medical malpractice system is “blocking efforts at patient safety,” said Troyen A. Brennan, M.D., professor of medicine at Harvard Medical School, Boston, and professor of law and public health at the Harvard School of Public Health. A new medical malpractice system should be established to separate compensation for injuries from deterrence, Dr. Brennan said.

For that to happen, liability for negligence has to be eliminated, and reporting has to be made based on injuries to the patient. “You have to enable open and honest reporting,” he added.

Physicians also have to realize that reporting patient injury is part of their professional responsibility, he said.

Currently, some physicians do not disclose medical errors or injuries. That may be a rational economic response to physicians' rising premiums and fear of facing a lawsuit, Dr. Brennan said, but it definitely is not an ethical response.

ALEXANDRIA, VA.—Traditional tort reform measures like damage caps won't address some of the fundamental problems with the medical liability system, experts said at a meeting on patient safety and medical liability sponsored by the Joint Commission on Accreditation of Healthcare Organizations.

To deal with the current malpractice situation, the medical community needs to address the reasons why people sue—injuries, unmet expenses, and anger, said Lucian L. Leape, M.D., of the department of health policy and management at the Harvard School of Public Health, Boston.

“The main reason most people sue is because they are angry at the physician,” Dr. Leape said.

But the current system and the most commonly proposed reforms, such as damage caps, don't address the need to increase disclosure of errors to patients or incentivize physicians to offer apologies, he said.

Traditional reform measures such as damage caps would undercompensate seriously injured patients and increase administrative costs, Michelle M. Mello, Ph.D., of Harvard School of Public Health, Boston, said. And they would not help deter medical malpractice.

Damage caps also fail to address the poor correlation between medical injury and malpractice claims, she said. Instead of focusing on caps, the medical community needs to consider an administrative compensation system to replace torts.

The medical malpractice system is “blocking efforts at patient safety,” said Troyen A. Brennan, M.D., professor of medicine at Harvard Medical School, Boston, and professor of law and public health at the Harvard School of Public Health. A new medical malpractice system should be established to separate compensation for injuries from deterrence, Dr. Brennan said.

For that to happen, liability for negligence has to be eliminated, and reporting has to be made based on injuries to the patient. “You have to enable open and honest reporting,” he added.

Physicians also have to realize that reporting patient injury is part of their professional responsibility, he said.

Currently, some physicians do not disclose medical errors or injuries. That may be a rational economic response to physicians' rising premiums and fear of facing a lawsuit, Dr. Brennan said, but it definitely is not an ethical response.

WASHINGTON — Medicare managed care plans, known as Medicare Advantage, can now design targeted plans for low-income and institutionalized patients.

“Those are the beneficiaries who have the most to gain from our health care system but only if they get help in maneuvering the complexity and putting all the different kinds of services that they need to receive together in an effective way,” said Mark McClellan, M.D., administrator for the Centers for Medicare and Medicaid Services.

Under the 2003 Medicare Modernization Act, Medicare Advantage plans can limit enrollment to beneficiaries who are dually eligible for Medicare and Medicaid, or long-term institutionalized beneficiaries.

Already health plans are starting to take advantage of the new provisions, Dr. McClellan said at a meeting on Medicare and Medicaid sponsored by America's Health Insurance Plans.

This new option is a key way for Medicare, which was originally designed to care for acute problems, to begin addressing the increasing needs of low-income and frail seniors, said Patricia Smith, director of the Medicare Advantage Group at CMS.

“It's a baby step for the program, but it's a very important one,” she said.

Under CMS interim guidance, health plans have to offer the specialty plan to the entire group of dual eligibles, instead of targeting a subset of that group. Plans can't just target the Qualified Medicare Beneficiaries or the Special Low-income Medicare Beneficiaries, said Danielle Moon of CMS.

With institutionalized patients, plans are limited to those who reside or who are expected to reside continuously for 90 days or longer in a skilled nursing facility or nursing facility. CMS also can pecify other chronically ill or disabled beneficiaries who could benefit from a specialized plan. Agency officials are still working on a definition of these beneficiaries.

WASHINGTON — Medicare managed care plans, known as Medicare Advantage, can now design targeted plans for low-income and institutionalized patients.

“Those are the beneficiaries who have the most to gain from our health care system but only if they get help in maneuvering the complexity and putting all the different kinds of services that they need to receive together in an effective way,” said Mark McClellan, M.D., administrator for the Centers for Medicare and Medicaid Services.

Under the 2003 Medicare Modernization Act, Medicare Advantage plans can limit enrollment to beneficiaries who are dually eligible for Medicare and Medicaid, or long-term institutionalized beneficiaries.

Already health plans are starting to take advantage of the new provisions, Dr. McClellan said at a meeting on Medicare and Medicaid sponsored by America's Health Insurance Plans.

This new option is a key way for Medicare, which was originally designed to care for acute problems, to begin addressing the increasing needs of low-income and frail seniors, said Patricia Smith, director of the Medicare Advantage Group at CMS.

“It's a baby step for the program, but it's a very important one,” she said.

Under CMS interim guidance, health plans have to offer the specialty plan to the entire group of dual eligibles, instead of targeting a subset of that group. Plans can't just target the Qualified Medicare Beneficiaries or the Special Low-income Medicare Beneficiaries, said Danielle Moon of CMS.

With institutionalized patients, plans are limited to those who reside or who are expected to reside continuously for 90 days or longer in a skilled nursing facility or nursing facility. CMS also can pecify other chronically ill or disabled beneficiaries who could benefit from a specialized plan. Agency officials are still working on a definition of these beneficiaries.

WASHINGTON — Medicare managed care plans, known as Medicare Advantage, can now design targeted plans for low-income and institutionalized patients.

“Those are the beneficiaries who have the most to gain from our health care system but only if they get help in maneuvering the complexity and putting all the different kinds of services that they need to receive together in an effective way,” said Mark McClellan, M.D., administrator for the Centers for Medicare and Medicaid Services.

Under the 2003 Medicare Modernization Act, Medicare Advantage plans can limit enrollment to beneficiaries who are dually eligible for Medicare and Medicaid, or long-term institutionalized beneficiaries.

Already health plans are starting to take advantage of the new provisions, Dr. McClellan said at a meeting on Medicare and Medicaid sponsored by America's Health Insurance Plans.

This new option is a key way for Medicare, which was originally designed to care for acute problems, to begin addressing the increasing needs of low-income and frail seniors, said Patricia Smith, director of the Medicare Advantage Group at CMS.

“It's a baby step for the program, but it's a very important one,” she said.

Under CMS interim guidance, health plans have to offer the specialty plan to the entire group of dual eligibles, instead of targeting a subset of that group. Plans can't just target the Qualified Medicare Beneficiaries or the Special Low-income Medicare Beneficiaries, said Danielle Moon of CMS.

With institutionalized patients, plans are limited to those who reside or who are expected to reside continuously for 90 days or longer in a skilled nursing facility or nursing facility. CMS also can pecify other chronically ill or disabled beneficiaries who could benefit from a specialized plan. Agency officials are still working on a definition of these beneficiaries.

The standard-setting group U.S. Pharmacopeia has established 146 unique therapeutic categories and pharmacologic classes to guide the establishment of formularies under the new Medicare Part D prescription drug benefit.

The model guidelines created by USP will serve as a voluntary framework for health plans and prescription drug plans as they create drug plan formularies for Medicare, as established by the Medicare Modernization Act of 2003.

“The model guidelines are not a formulary,” Roger L. Williams, M.D., USP executive vice president and CEO and chair of the group's Model Guidelines Expert Committee, said in a press teleconference.

In addition to the categories and classes created by USP, the group also created a separate listing of formulary key drug types to help the Centers for Medicare and Medicaid Services assess the comprehensiveness of proposed formularies.

Under proposed Medicare regulations, plans that follow the model guidelines would need to offer at least two drugs in each therapeutic category and pharmacologic class. USP has also recommended that CMS require plans to offer at least one drug from the list of formulary key drug types or have a clinical or scientific rationale for excluding the drugs.

CMS officials will use the guidelines to help evaluate proposed formularies.

The USP issued draft guidelines last August that were criticized by physician groups and patient advocates as leaving too many critical drugs in a third category, where they would not be required to be covered.

The final guidelines include a new therapeutic category for inflammatory bowel disease agents and a new pharmacologic class for proton pump inhibitors. Other changes to the model guidelines include additional antidementia drugs and expanded dermatologic agents.

Dr. Williams said that he hopes all parties will see the final guidelines as “workable compromise.”

The American College of Rheumatology (ACR) applauded USP's efforts in putting together the model guidelines and called it a good place to start. But much will depend upon how CMS decides to use the guidelines, said Pam Ferraro, a regulatory analyst for ACR.

Many of the drugs of interest to rheumatologists, such as tumor necrosis factor inhibitors, were not included as either therapeutic categories or pharmacologic classes but were part of USP's list of formulary key drug types. ACR officials want to see drug plans cover the medications in this third category and make them available at affordable prices, Ms. Ferraro said.

The National Mental Health Association (NMHA) warned that the USP guidelines ignore recommendations from the mental health field not to group older medications with newer therapies. The association said that because these different medications are lumped together, health plans could choose to cover only the older, less expensive drugs. But NMHA president and CEO Michael M. Faenza said in a statement that his group is encouraged that CMS plans to consider widely accepted treatment guidelines for mental health when reviewing formularies.

But America's Health Insurance Plans (AHIP) praised the USP's final document.

“The final model continues to provide needed flexibility by not expanding the number of categories and classes previously proposed,” said Karen Ignagni, AHIP president and CEO. “The direction that CMS is clearly taking supports the building of effective private plan strategies to make the Part D benefit clinically appropriate and affordable for Medicare beneficiaries.”

Officials at the Pharmaceutical Research and Manufacturers of America, which has supported access to a broad array of treatments, were still reviewing the document at press time.

The standard-setting group U.S. Pharmacopeia has established 146 unique therapeutic categories and pharmacologic classes to guide the establishment of formularies under the new Medicare Part D prescription drug benefit.

The model guidelines created by USP will serve as a voluntary framework for health plans and prescription drug plans as they create drug plan formularies for Medicare, as established by the Medicare Modernization Act of 2003.

“The model guidelines are not a formulary,” Roger L. Williams, M.D., USP executive vice president and CEO and chair of the group's Model Guidelines Expert Committee, said in a press teleconference.

In addition to the categories and classes created by USP, the group also created a separate listing of formulary key drug types to help the Centers for Medicare and Medicaid Services assess the comprehensiveness of proposed formularies.

Under proposed Medicare regulations, plans that follow the model guidelines would need to offer at least two drugs in each therapeutic category and pharmacologic class. USP has also recommended that CMS require plans to offer at least one drug from the list of formulary key drug types or have a clinical or scientific rationale for excluding the drugs.

CMS officials will use the guidelines to help evaluate proposed formularies.

The USP issued draft guidelines last August that were criticized by physician groups and patient advocates as leaving too many critical drugs in a third category, where they would not be required to be covered.

The final guidelines include a new therapeutic category for inflammatory bowel disease agents and a new pharmacologic class for proton pump inhibitors. Other changes to the model guidelines include additional antidementia drugs and expanded dermatologic agents.

Dr. Williams said that he hopes all parties will see the final guidelines as “workable compromise.”

The American College of Rheumatology (ACR) applauded USP's efforts in putting together the model guidelines and called it a good place to start. But much will depend upon how CMS decides to use the guidelines, said Pam Ferraro, a regulatory analyst for ACR.

Many of the drugs of interest to rheumatologists, such as tumor necrosis factor inhibitors, were not included as either therapeutic categories or pharmacologic classes but were part of USP's list of formulary key drug types. ACR officials want to see drug plans cover the medications in this third category and make them available at affordable prices, Ms. Ferraro said.

The National Mental Health Association (NMHA) warned that the USP guidelines ignore recommendations from the mental health field not to group older medications with newer therapies. The association said that because these different medications are lumped together, health plans could choose to cover only the older, less expensive drugs. But NMHA president and CEO Michael M. Faenza said in a statement that his group is encouraged that CMS plans to consider widely accepted treatment guidelines for mental health when reviewing formularies.

But America's Health Insurance Plans (AHIP) praised the USP's final document.

“The final model continues to provide needed flexibility by not expanding the number of categories and classes previously proposed,” said Karen Ignagni, AHIP president and CEO. “The direction that CMS is clearly taking supports the building of effective private plan strategies to make the Part D benefit clinically appropriate and affordable for Medicare beneficiaries.”

Officials at the Pharmaceutical Research and Manufacturers of America, which has supported access to a broad array of treatments, were still reviewing the document at press time.

The standard-setting group U.S. Pharmacopeia has established 146 unique therapeutic categories and pharmacologic classes to guide the establishment of formularies under the new Medicare Part D prescription drug benefit.

The model guidelines created by USP will serve as a voluntary framework for health plans and prescription drug plans as they create drug plan formularies for Medicare, as established by the Medicare Modernization Act of 2003.

“The model guidelines are not a formulary,” Roger L. Williams, M.D., USP executive vice president and CEO and chair of the group's Model Guidelines Expert Committee, said in a press teleconference.

In addition to the categories and classes created by USP, the group also created a separate listing of formulary key drug types to help the Centers for Medicare and Medicaid Services assess the comprehensiveness of proposed formularies.

Under proposed Medicare regulations, plans that follow the model guidelines would need to offer at least two drugs in each therapeutic category and pharmacologic class. USP has also recommended that CMS require plans to offer at least one drug from the list of formulary key drug types or have a clinical or scientific rationale for excluding the drugs.

CMS officials will use the guidelines to help evaluate proposed formularies.

The USP issued draft guidelines last August that were criticized by physician groups and patient advocates as leaving too many critical drugs in a third category, where they would not be required to be covered.

The final guidelines include a new therapeutic category for inflammatory bowel disease agents and a new pharmacologic class for proton pump inhibitors. Other changes to the model guidelines include additional antidementia drugs and expanded dermatologic agents.

Dr. Williams said that he hopes all parties will see the final guidelines as “workable compromise.”

The American College of Rheumatology (ACR) applauded USP's efforts in putting together the model guidelines and called it a good place to start. But much will depend upon how CMS decides to use the guidelines, said Pam Ferraro, a regulatory analyst for ACR.

Many of the drugs of interest to rheumatologists, such as tumor necrosis factor inhibitors, were not included as either therapeutic categories or pharmacologic classes but were part of USP's list of formulary key drug types. ACR officials want to see drug plans cover the medications in this third category and make them available at affordable prices, Ms. Ferraro said.

The National Mental Health Association (NMHA) warned that the USP guidelines ignore recommendations from the mental health field not to group older medications with newer therapies. The association said that because these different medications are lumped together, health plans could choose to cover only the older, less expensive drugs. But NMHA president and CEO Michael M. Faenza said in a statement that his group is encouraged that CMS plans to consider widely accepted treatment guidelines for mental health when reviewing formularies.

But America's Health Insurance Plans (AHIP) praised the USP's final document.

“The final model continues to provide needed flexibility by not expanding the number of categories and classes previously proposed,” said Karen Ignagni, AHIP president and CEO. “The direction that CMS is clearly taking supports the building of effective private plan strategies to make the Part D benefit clinically appropriate and affordable for Medicare beneficiaries.”

Officials at the Pharmaceutical Research and Manufacturers of America, which has supported access to a broad array of treatments, were still reviewing the document at press time.

WASHINGTON – Physicians are experimenting with better ways to communicate with patients with low health literacy, Joanne Schwartzberg, M.D., said at a conference on health literacy sponsored by the American College of Physicians.

“It's right in the lap of every physician,” said Dr. Schwartzberg, director of aging and community health at the American Medical Association. “Physicians can't say it's someone else's problem.” Using simple language, distributing patient education materials, speaking slowly, reading instructions aloud, asking patients how they follow instructions at home, using teach-back techniques, and drawing pictures are some of the ways health care providers say they are trying to do a better job of reaching out to patients with low health literacy, Dr. Schwartzberg said.

The AMA has developed a health literacy kit with a video and manual for clinicians. The group has also started a train-the-trainer program. To date, the group has trained 11 teams from state and specialty societies. In 6 months, the first 5 teams have conducted 57 trainings and reached more than 1,500 physicians, she said.

Preliminary results show that after the training, a majority of the physicians changed their communication with patients. For example, many reported that they were more often asking patients to repeat back instructions.

Reaching out to patients with low health literacy is especially important in managing chronic disease because there is a “mismatch” between the capabilities of individuals and the demands of their diseases, said Dean Schillinger, M.D., associate professor of medicine at the University of California, San Francisco.

For example, in examining the interactions between physicians and patients with type 2 diabetes, Dr. Schillinger found that physicians used a lot of medical jargon providing recommendations to patients. Patients with low health literacy were confused by terms that physicians might expect a chronic diabetes patient to know, such as “glucometer.” And more research is still needed on what interventions work, especially if the medical community is going to ask insurers to offer financial incentives, said David Kindig, M.D., chair of the Institute of Medicine Committee on Health Literacy.

WASHINGTON – Physicians are experimenting with better ways to communicate with patients with low health literacy, Joanne Schwartzberg, M.D., said at a conference on health literacy sponsored by the American College of Physicians.

“It's right in the lap of every physician,” said Dr. Schwartzberg, director of aging and community health at the American Medical Association. “Physicians can't say it's someone else's problem.” Using simple language, distributing patient education materials, speaking slowly, reading instructions aloud, asking patients how they follow instructions at home, using teach-back techniques, and drawing pictures are some of the ways health care providers say they are trying to do a better job of reaching out to patients with low health literacy, Dr. Schwartzberg said.

The AMA has developed a health literacy kit with a video and manual for clinicians. The group has also started a train-the-trainer program. To date, the group has trained 11 teams from state and specialty societies. In 6 months, the first 5 teams have conducted 57 trainings and reached more than 1,500 physicians, she said.

Preliminary results show that after the training, a majority of the physicians changed their communication with patients. For example, many reported that they were more often asking patients to repeat back instructions.

Reaching out to patients with low health literacy is especially important in managing chronic disease because there is a “mismatch” between the capabilities of individuals and the demands of their diseases, said Dean Schillinger, M.D., associate professor of medicine at the University of California, San Francisco.

For example, in examining the interactions between physicians and patients with type 2 diabetes, Dr. Schillinger found that physicians used a lot of medical jargon providing recommendations to patients. Patients with low health literacy were confused by terms that physicians might expect a chronic diabetes patient to know, such as “glucometer.” And more research is still needed on what interventions work, especially if the medical community is going to ask insurers to offer financial incentives, said David Kindig, M.D., chair of the Institute of Medicine Committee on Health Literacy.

WASHINGTON – Physicians are experimenting with better ways to communicate with patients with low health literacy, Joanne Schwartzberg, M.D., said at a conference on health literacy sponsored by the American College of Physicians.

“It's right in the lap of every physician,” said Dr. Schwartzberg, director of aging and community health at the American Medical Association. “Physicians can't say it's someone else's problem.” Using simple language, distributing patient education materials, speaking slowly, reading instructions aloud, asking patients how they follow instructions at home, using teach-back techniques, and drawing pictures are some of the ways health care providers say they are trying to do a better job of reaching out to patients with low health literacy, Dr. Schwartzberg said.

The AMA has developed a health literacy kit with a video and manual for clinicians. The group has also started a train-the-trainer program. To date, the group has trained 11 teams from state and specialty societies. In 6 months, the first 5 teams have conducted 57 trainings and reached more than 1,500 physicians, she said.

Preliminary results show that after the training, a majority of the physicians changed their communication with patients. For example, many reported that they were more often asking patients to repeat back instructions.

Reaching out to patients with low health literacy is especially important in managing chronic disease because there is a “mismatch” between the capabilities of individuals and the demands of their diseases, said Dean Schillinger, M.D., associate professor of medicine at the University of California, San Francisco.

For example, in examining the interactions between physicians and patients with type 2 diabetes, Dr. Schillinger found that physicians used a lot of medical jargon providing recommendations to patients. Patients with low health literacy were confused by terms that physicians might expect a chronic diabetes patient to know, such as “glucometer.” And more research is still needed on what interventions work, especially if the medical community is going to ask insurers to offer financial incentives, said David Kindig, M.D., chair of the Institute of Medicine Committee on Health Literacy.

A limited, commercial program that would import drugs from Canada is feasible but would result in limited savings for consumers, members of a government task force on drug importation said at a press briefing sponsored by the Health and Human Services Department.

The HHS-convened task force dismissed the idea of personal importation of drugs from other countries as being extraordinarily difficult and costly to implement safely.

It could cost as much as $3 billion a year to regulate personal importation, according to a letter sent to congressional leaders from the secretaries of HHS and the Commerce Department.

“Any plan to permit importation must be limited to commercial importation of a discrete number of high-volume, high-cost prescription drugs from a country with equivalent drug safety protections,” according to the secretaries. “These drugs must have the same level of safety and effectiveness as FDA-approved products.”

In the letter, Bush administration officials outlined the requirements of such a system. For example, it should require drug pedigrees, limit ports of entry and distribution channels, and allow commercial importation only from licensed foreign wholesalers to authorized sellers in the United States.

A commercial program would have to be limited to those prescription drugs that are mostly likely to yield savings, such as a high-volume drug without a U.S.-approved generic. The administration is also asking Congress to exclude drugs or classes of drugs that could pose increased safety risks in an importation program, such as controlled substances or drugs that require refrigeration during shipping.

And the program must avoid “anticompetitive provisions” including “forced sale” clauses and other types of price controls.

The letter also warns Congress that if its members pass legislation that stifles competition or fails to address safety concerns, the president's senior advisors will recommend a veto.

None of the legislation previously introduced in Congress would meet these criteria since most of it deals with personal importation of drugs, a senior administration official said in a teleconference announcing the release of the report.

The American Medical Association recently took a similar position on drug importation. The group said that it supports importation of prescription drugs by wholesalers and pharmacies, provided that the drugs have been FDA approved and are part of a closed distribution chain. AMA does not support personal importation via the Internet until patient safety can be assured.

“Patient safety must remain the overriding concern as we work to make prescription drugs more available and affordable for patients. Patients must be protected from unapproved drugs that could be unsafe, expired, counterfeit, adulterated, misbranded, or inappropriately labeled,” AMA Trustee Edward L. Langston, M.D., said in a statement.

But Sen. Byron Dorgan (D-N.D.), a leading proponent of the importation of drugs from other countries, said he never had much confidence that the HHS study would be objective and plans to introduce reimportation legislation.

“Millions of American obtain prescription medicines from Canada and other countries every year and do so safely,” Sen. Dorgan said in a statement. “The federal government itself is buying flu vaccine from abroad right now. The only thing endangered by allowing Americans access to lower priced FDA-approved medicines from abroad is the incredibly large profits of the drug companies who overprice their medicines in our market, just because they can.”

The HHS task force was formed early in 2004 to address questions posed by Congress in the Medicare Modernization Act. The law includes a provision that would allow the importation of prescription drugs from Canada if the HHS secretary certifies that the drugs pose no additional risk to public health and safety and would offer significant savings to U.S. consumers.

The HHS Task Force report on prescription drug importation is available online atwww.hhs.gov/importtaskforce

A limited, commercial program that would import drugs from Canada is feasible but would result in limited savings for consumers, members of a government task force on drug importation said at a press briefing sponsored by the Health and Human Services Department.

The HHS-convened task force dismissed the idea of personal importation of drugs from other countries as being extraordinarily difficult and costly to implement safely.

It could cost as much as $3 billion a year to regulate personal importation, according to a letter sent to congressional leaders from the secretaries of HHS and the Commerce Department.

“Any plan to permit importation must be limited to commercial importation of a discrete number of high-volume, high-cost prescription drugs from a country with equivalent drug safety protections,” according to the secretaries. “These drugs must have the same level of safety and effectiveness as FDA-approved products.”

In the letter, Bush administration officials outlined the requirements of such a system. For example, it should require drug pedigrees, limit ports of entry and distribution channels, and allow commercial importation only from licensed foreign wholesalers to authorized sellers in the United States.

A commercial program would have to be limited to those prescription drugs that are mostly likely to yield savings, such as a high-volume drug without a U.S.-approved generic. The administration is also asking Congress to exclude drugs or classes of drugs that could pose increased safety risks in an importation program, such as controlled substances or drugs that require refrigeration during shipping.

And the program must avoid “anticompetitive provisions” including “forced sale” clauses and other types of price controls.

The letter also warns Congress that if its members pass legislation that stifles competition or fails to address safety concerns, the president's senior advisors will recommend a veto.

None of the legislation previously introduced in Congress would meet these criteria since most of it deals with personal importation of drugs, a senior administration official said in a teleconference announcing the release of the report.

The American Medical Association recently took a similar position on drug importation. The group said that it supports importation of prescription drugs by wholesalers and pharmacies, provided that the drugs have been FDA approved and are part of a closed distribution chain. AMA does not support personal importation via the Internet until patient safety can be assured.

“Patient safety must remain the overriding concern as we work to make prescription drugs more available and affordable for patients. Patients must be protected from unapproved drugs that could be unsafe, expired, counterfeit, adulterated, misbranded, or inappropriately labeled,” AMA Trustee Edward L. Langston, M.D., said in a statement.

But Sen. Byron Dorgan (D-N.D.), a leading proponent of the importation of drugs from other countries, said he never had much confidence that the HHS study would be objective and plans to introduce reimportation legislation.

“Millions of American obtain prescription medicines from Canada and other countries every year and do so safely,” Sen. Dorgan said in a statement. “The federal government itself is buying flu vaccine from abroad right now. The only thing endangered by allowing Americans access to lower priced FDA-approved medicines from abroad is the incredibly large profits of the drug companies who overprice their medicines in our market, just because they can.”

The HHS task force was formed early in 2004 to address questions posed by Congress in the Medicare Modernization Act. The law includes a provision that would allow the importation of prescription drugs from Canada if the HHS secretary certifies that the drugs pose no additional risk to public health and safety and would offer significant savings to U.S. consumers.

The HHS Task Force report on prescription drug importation is available online atwww.hhs.gov/importtaskforce

A limited, commercial program that would import drugs from Canada is feasible but would result in limited savings for consumers, members of a government task force on drug importation said at a press briefing sponsored by the Health and Human Services Department.

The HHS-convened task force dismissed the idea of personal importation of drugs from other countries as being extraordinarily difficult and costly to implement safely.

It could cost as much as $3 billion a year to regulate personal importation, according to a letter sent to congressional leaders from the secretaries of HHS and the Commerce Department.

“Any plan to permit importation must be limited to commercial importation of a discrete number of high-volume, high-cost prescription drugs from a country with equivalent drug safety protections,” according to the secretaries. “These drugs must have the same level of safety and effectiveness as FDA-approved products.”

In the letter, Bush administration officials outlined the requirements of such a system. For example, it should require drug pedigrees, limit ports of entry and distribution channels, and allow commercial importation only from licensed foreign wholesalers to authorized sellers in the United States.

A commercial program would have to be limited to those prescription drugs that are mostly likely to yield savings, such as a high-volume drug without a U.S.-approved generic. The administration is also asking Congress to exclude drugs or classes of drugs that could pose increased safety risks in an importation program, such as controlled substances or drugs that require refrigeration during shipping.

And the program must avoid “anticompetitive provisions” including “forced sale” clauses and other types of price controls.

The letter also warns Congress that if its members pass legislation that stifles competition or fails to address safety concerns, the president's senior advisors will recommend a veto.

None of the legislation previously introduced in Congress would meet these criteria since most of it deals with personal importation of drugs, a senior administration official said in a teleconference announcing the release of the report.

The American Medical Association recently took a similar position on drug importation. The group said that it supports importation of prescription drugs by wholesalers and pharmacies, provided that the drugs have been FDA approved and are part of a closed distribution chain. AMA does not support personal importation via the Internet until patient safety can be assured.

“Patient safety must remain the overriding concern as we work to make prescription drugs more available and affordable for patients. Patients must be protected from unapproved drugs that could be unsafe, expired, counterfeit, adulterated, misbranded, or inappropriately labeled,” AMA Trustee Edward L. Langston, M.D., said in a statement.

But Sen. Byron Dorgan (D-N.D.), a leading proponent of the importation of drugs from other countries, said he never had much confidence that the HHS study would be objective and plans to introduce reimportation legislation.

“Millions of American obtain prescription medicines from Canada and other countries every year and do so safely,” Sen. Dorgan said in a statement. “The federal government itself is buying flu vaccine from abroad right now. The only thing endangered by allowing Americans access to lower priced FDA-approved medicines from abroad is the incredibly large profits of the drug companies who overprice their medicines in our market, just because they can.”

The HHS task force was formed early in 2004 to address questions posed by Congress in the Medicare Modernization Act. The law includes a provision that would allow the importation of prescription drugs from Canada if the HHS secretary certifies that the drugs pose no additional risk to public health and safety and would offer significant savings to U.S. consumers.

The HHS Task Force report on prescription drug importation is available online atwww.hhs.gov/importtaskforce

As physicians push for professional liability reform at the national level, the Maryland legislature signed off on a bill aimed at halting rising malpractice premiums.

The centerpiece of the legislation is a rate stabilization fund for medical professional liability insurance that will be funded through a tax on HMOs.

The Maryland State Medical Society (MedChi) and the Maryland Hospital Association estimate that the fund would cover about 95% of the increase in premiums for 2005. Obstetricians in Maryland are paying about $120,000–$160,000 for insurance coverage this year.

Maryland physicians have been pushing hard for reform–especially since last fall, when the state's largest malpractice carrier, Medical Mutual of Maryland, said it would raise its premium rates in 2005 an average 33%. The move follows a 28% increase a year ago.

Maryland is considered a medical liability insurance crisis state by the American College of Obstetricians and Gynecologists. And physicians of all specialties in the state are choosing to lay off staff, close practices, or move, in order to deal with the malpractice problem, according to MedChi.

The new legislation was passed in dramatic fashion during an end-of-the-year special session called by Gov. Robert Ehrlich.

But he objected to the HMO tax and said the bill didn't contain meaningful tort reform. He then vetoed the measure in January, but legislators returned to work to override the veto.

The saga is expected to continue as Gov. Ehrlich prepares to introduce other legislation with more comprehensive reforms.

The state's physician and hospital groups are applauding the new legislation as an important first step. “While we agree with the governor and others that Maryland needs more comprehensive reform, it does offer important positive elements that we cannot walk away from, given the need to assure access to health care to the citizens of Maryland,” MedChi and the Maryland Hospital Association said in a joint statement. “We believe this bill will keep physicians on the job.”

The groups pointed out that the measure contains a reduction in the cap on noneconomic damages in death cases, reform of how past medical expenses are calculated, and new requirements for expert witnesses.

However, the legislation fails to include needed reforms such as mandatory structured settlements of awards, an expansion of the Good Samaritan Act to include emergency department professionals, and parameters on the calculation of future economic damages, the groups said.

Although there is still more work to be done, the attention brought to medical liability reform through the special session is good news for physicians, said Willarda V. Edwards, M.D., an internist in South Baltimore and MedChi president.

The increased awareness and the better understanding of the issues that resulted from the special session will help as physicians seek increased reform this year, she said. MedChi plans to pursue limits on lawyers' fees, structured settlements that can be paid over time, reforming the calculation of economic damage payments, and enactment of a Good Samaritan law.

“This is just a little taste of what we think should be done,” Dr. Edwards said.

But physicians in Maryland are still waiting to see what the current legislation will mean in terms of premiums. “It's too early to say how this is going work,” said Miriam Yudkoff, M.D., an ob.gyn. in Annapolis.

And Dr. Yudkoff said she has some concerns about what the insurance reform provisions in the legislation will mean for liability carriers. If Maryland becomes an unprofitable place for insurers, it could have a significant impact on physicians' ability to obtain coverage. “We need a bill that will make Maryland a favorable state for carriers,” she said.

Carol Ritter, M.D., a solo gynecologist in Towson, who gave up obstetrics last year, said she sees the legislation as a first step in reform. However, the changes prescribed by the legislation aren't enough to make her able to afford to practice obstetrics again.

The rate stabilization fund is likely to limit the 2005 average premium increase, Dr. Ritter said, but premiums will still be more than 2004 rates, which were already more than she could afford. However, Dr. Ritter said she's hopeful that it will allow some of her colleagues to stay in practice in the short term.

The legislation also won't help David Zisow, M.D., a gynecologist in Bel Air, to start practicing obstetrics again. Like Dr. Ritter, Dr. Zisow gave up obstetrics at the beginning of 2004 when the rates became too high. But even though the new legislation contains significant reforms, Dr. Zisow said he wouldn't be able to afford to buy the tail coverage that would be necessary to start practicing obstetrics again.

His insurer, Medical Mutual, allowed him to forego paying tail coverage for obstetrics because of his many years with the company. However, he would have to pay a significant amount if he were to go back into obstetrics, he said.

As it is, Dr. Zisow has already seen a major increase in his premiums for gynecology alone in 2005, and he said he isn't optimistic that the legislation will result in too much change in premiums.

“It's business as usual,” he said.

This is a wake-up call to physicians to get politically active, said Mark Seigel, M.D., an ob.gyn. in Gaithersburg and the former president of MedChi. Passing meaningful changes to the system takes time, he said, and ultimately it may mean voting officials out of office who fail to take on medical liability reform. “Doctors have to do more than just go to the office and see patients,” Dr. Seigel said.

As physicians push for professional liability reform at the national level, the Maryland legislature signed off on a bill aimed at halting rising malpractice premiums.

The centerpiece of the legislation is a rate stabilization fund for medical professional liability insurance that will be funded through a tax on HMOs.

The Maryland State Medical Society (MedChi) and the Maryland Hospital Association estimate that the fund would cover about 95% of the increase in premiums for 2005. Obstetricians in Maryland are paying about $120,000–$160,000 for insurance coverage this year.

Maryland physicians have been pushing hard for reform–especially since last fall, when the state's largest malpractice carrier, Medical Mutual of Maryland, said it would raise its premium rates in 2005 an average 33%. The move follows a 28% increase a year ago.

Maryland is considered a medical liability insurance crisis state by the American College of Obstetricians and Gynecologists. And physicians of all specialties in the state are choosing to lay off staff, close practices, or move, in order to deal with the malpractice problem, according to MedChi.

The new legislation was passed in dramatic fashion during an end-of-the-year special session called by Gov. Robert Ehrlich.

But he objected to the HMO tax and said the bill didn't contain meaningful tort reform. He then vetoed the measure in January, but legislators returned to work to override the veto.

The saga is expected to continue as Gov. Ehrlich prepares to introduce other legislation with more comprehensive reforms.

The state's physician and hospital groups are applauding the new legislation as an important first step. “While we agree with the governor and others that Maryland needs more comprehensive reform, it does offer important positive elements that we cannot walk away from, given the need to assure access to health care to the citizens of Maryland,” MedChi and the Maryland Hospital Association said in a joint statement. “We believe this bill will keep physicians on the job.”

The groups pointed out that the measure contains a reduction in the cap on noneconomic damages in death cases, reform of how past medical expenses are calculated, and new requirements for expert witnesses.

However, the legislation fails to include needed reforms such as mandatory structured settlements of awards, an expansion of the Good Samaritan Act to include emergency department professionals, and parameters on the calculation of future economic damages, the groups said.

Although there is still more work to be done, the attention brought to medical liability reform through the special session is good news for physicians, said Willarda V. Edwards, M.D., an internist in South Baltimore and MedChi president.

The increased awareness and the better understanding of the issues that resulted from the special session will help as physicians seek increased reform this year, she said. MedChi plans to pursue limits on lawyers' fees, structured settlements that can be paid over time, reforming the calculation of economic damage payments, and enactment of a Good Samaritan law.

“This is just a little taste of what we think should be done,” Dr. Edwards said.

But physicians in Maryland are still waiting to see what the current legislation will mean in terms of premiums. “It's too early to say how this is going work,” said Miriam Yudkoff, M.D., an ob.gyn. in Annapolis.

And Dr. Yudkoff said she has some concerns about what the insurance reform provisions in the legislation will mean for liability carriers. If Maryland becomes an unprofitable place for insurers, it could have a significant impact on physicians' ability to obtain coverage. “We need a bill that will make Maryland a favorable state for carriers,” she said.

Carol Ritter, M.D., a solo gynecologist in Towson, who gave up obstetrics last year, said she sees the legislation as a first step in reform. However, the changes prescribed by the legislation aren't enough to make her able to afford to practice obstetrics again.

The rate stabilization fund is likely to limit the 2005 average premium increase, Dr. Ritter said, but premiums will still be more than 2004 rates, which were already more than she could afford. However, Dr. Ritter said she's hopeful that it will allow some of her colleagues to stay in practice in the short term.

The legislation also won't help David Zisow, M.D., a gynecologist in Bel Air, to start practicing obstetrics again. Like Dr. Ritter, Dr. Zisow gave up obstetrics at the beginning of 2004 when the rates became too high. But even though the new legislation contains significant reforms, Dr. Zisow said he wouldn't be able to afford to buy the tail coverage that would be necessary to start practicing obstetrics again.

His insurer, Medical Mutual, allowed him to forego paying tail coverage for obstetrics because of his many years with the company. However, he would have to pay a significant amount if he were to go back into obstetrics, he said.

As it is, Dr. Zisow has already seen a major increase in his premiums for gynecology alone in 2005, and he said he isn't optimistic that the legislation will result in too much change in premiums.

“It's business as usual,” he said.

This is a wake-up call to physicians to get politically active, said Mark Seigel, M.D., an ob.gyn. in Gaithersburg and the former president of MedChi. Passing meaningful changes to the system takes time, he said, and ultimately it may mean voting officials out of office who fail to take on medical liability reform. “Doctors have to do more than just go to the office and see patients,” Dr. Seigel said.

As physicians push for professional liability reform at the national level, the Maryland legislature signed off on a bill aimed at halting rising malpractice premiums.

The centerpiece of the legislation is a rate stabilization fund for medical professional liability insurance that will be funded through a tax on HMOs.

The Maryland State Medical Society (MedChi) and the Maryland Hospital Association estimate that the fund would cover about 95% of the increase in premiums for 2005. Obstetricians in Maryland are paying about $120,000–$160,000 for insurance coverage this year.

Maryland physicians have been pushing hard for reform–especially since last fall, when the state's largest malpractice carrier, Medical Mutual of Maryland, said it would raise its premium rates in 2005 an average 33%. The move follows a 28% increase a year ago.

Maryland is considered a medical liability insurance crisis state by the American College of Obstetricians and Gynecologists. And physicians of all specialties in the state are choosing to lay off staff, close practices, or move, in order to deal with the malpractice problem, according to MedChi.

The new legislation was passed in dramatic fashion during an end-of-the-year special session called by Gov. Robert Ehrlich.

But he objected to the HMO tax and said the bill didn't contain meaningful tort reform. He then vetoed the measure in January, but legislators returned to work to override the veto.

The saga is expected to continue as Gov. Ehrlich prepares to introduce other legislation with more comprehensive reforms.

The state's physician and hospital groups are applauding the new legislation as an important first step. “While we agree with the governor and others that Maryland needs more comprehensive reform, it does offer important positive elements that we cannot walk away from, given the need to assure access to health care to the citizens of Maryland,” MedChi and the Maryland Hospital Association said in a joint statement. “We believe this bill will keep physicians on the job.”

The groups pointed out that the measure contains a reduction in the cap on noneconomic damages in death cases, reform of how past medical expenses are calculated, and new requirements for expert witnesses.

However, the legislation fails to include needed reforms such as mandatory structured settlements of awards, an expansion of the Good Samaritan Act to include emergency department professionals, and parameters on the calculation of future economic damages, the groups said.

Although there is still more work to be done, the attention brought to medical liability reform through the special session is good news for physicians, said Willarda V. Edwards, M.D., an internist in South Baltimore and MedChi president.

The increased awareness and the better understanding of the issues that resulted from the special session will help as physicians seek increased reform this year, she said. MedChi plans to pursue limits on lawyers' fees, structured settlements that can be paid over time, reforming the calculation of economic damage payments, and enactment of a Good Samaritan law.

“This is just a little taste of what we think should be done,” Dr. Edwards said.

But physicians in Maryland are still waiting to see what the current legislation will mean in terms of premiums. “It's too early to say how this is going work,” said Miriam Yudkoff, M.D., an ob.gyn. in Annapolis.

And Dr. Yudkoff said she has some concerns about what the insurance reform provisions in the legislation will mean for liability carriers. If Maryland becomes an unprofitable place for insurers, it could have a significant impact on physicians' ability to obtain coverage. “We need a bill that will make Maryland a favorable state for carriers,” she said.

Carol Ritter, M.D., a solo gynecologist in Towson, who gave up obstetrics last year, said she sees the legislation as a first step in reform. However, the changes prescribed by the legislation aren't enough to make her able to afford to practice obstetrics again.

The rate stabilization fund is likely to limit the 2005 average premium increase, Dr. Ritter said, but premiums will still be more than 2004 rates, which were already more than she could afford. However, Dr. Ritter said she's hopeful that it will allow some of her colleagues to stay in practice in the short term.

The legislation also won't help David Zisow, M.D., a gynecologist in Bel Air, to start practicing obstetrics again. Like Dr. Ritter, Dr. Zisow gave up obstetrics at the beginning of 2004 when the rates became too high. But even though the new legislation contains significant reforms, Dr. Zisow said he wouldn't be able to afford to buy the tail coverage that would be necessary to start practicing obstetrics again.

His insurer, Medical Mutual, allowed him to forego paying tail coverage for obstetrics because of his many years with the company. However, he would have to pay a significant amount if he were to go back into obstetrics, he said.

As it is, Dr. Zisow has already seen a major increase in his premiums for gynecology alone in 2005, and he said he isn't optimistic that the legislation will result in too much change in premiums.

“It's business as usual,” he said.

This is a wake-up call to physicians to get politically active, said Mark Seigel, M.D., an ob.gyn. in Gaithersburg and the former president of MedChi. Passing meaningful changes to the system takes time, he said, and ultimately it may mean voting officials out of office who fail to take on medical liability reform. “Doctors have to do more than just go to the office and see patients,” Dr. Seigel said.