Joyce Frieden

PHILADELPHIA — A new service being offered by the National Practitioner Data Bank will make it easier for hospitals and other institutions to find out when a physician with privileges at their institution has had a data bank report filed on him or her by another entity.

The new program, called the Proactive Disclosure Service, is expected to start next spring, according to Shirley Jones, senior policy analyst at the Health Resources and Services Administration, Rockville, Md., the agency that runs the data bank.

The service allows the entity—a hospital or other facility—to register all practitioners who could potentially be subjects of data bank reports.

"Then, if the data bank gets a report on that practitioner, the data bank will automatically send the report to that entity," Ms. Jones explained at the annual meeting of the American Health Lawyers Association.

She added that the new program is "an alternative to, not a replacement for, the current querying service."

There will be a small charge to the facility for each person it registers, probably around $3 per practitioner, she said. Different entities can register the same practitioner.

Another change is a proposed regulation known as Section 1921, which will expand the data bank's reach, Ms. Jones continued.

"Section 1921 will expand the data that's in the data bank," Ms. Jones explained. "State licensing authorities must [now] report all adverse licensing actions about all practitioners," not just physicians and dentists.

That means that hospitals and other organizations can query the data bank on other health professionals such as nurses, respiratory therapists, and massage therapists, she said.

Another part of Section 1921 would require peer review organizations to report negative actions taken against individual practitioners.

However, she noted, quality improvement organizations would be exempt from that requirement under the proposed rule.

When it published the proposed rule earlier this year in the Federal Register, the Health Resources and Services Administration explained why it is exempting quality improvement organizations.

"First, the critical mission of the [quality improvement organization] program is its focus on maintaining collaborative relationships with providers and practitioners to improve the quality of health care services delivered to Medicare beneficiaries," the agency noted.

"The reporting of [quality improvement organization] sanction recommendations to the National Practitioner Data Bank will significantly interfere with the progress that has been made toward this goal and will substantially reduce the ability of quality improvement organizations to carry out their statutory and contractual obligations," according to the Health Resources and Services Administration.

The agency also expressed concern that requiring quality improvement organizations to report recommended sanctions to the data bank "may create misconceptions about the meaning of quality improvement organizations sanction recommendations," since they are only recommendations and may not always be acted on. The agency is still reviewing comments it has received on the proposed rule.

In addition to the new regulations that it is proposing, the data bank also has developed a compliance program to make sure that it is getting all the reports it should.

For example, data bank officials compare actions that have been documented on state licensing board Web sites with information that is in the data bank.

In addition, data bank staff look at newspapers, magazines, and public media "to see if we're missing something," Ms. Jones said.

PHILADELPHIA — A new service being offered by the National Practitioner Data Bank will make it easier for hospitals and other institutions to find out when a physician with privileges at their institution has had a data bank report filed on him or her by another entity.

The new program, called the Proactive Disclosure Service, is expected to start next spring, according to Shirley Jones, senior policy analyst at the Health Resources and Services Administration, Rockville, Md., the agency that runs the data bank.

The service allows the entity—a hospital or other facility—to register all practitioners who could potentially be subjects of data bank reports.

"Then, if the data bank gets a report on that practitioner, the data bank will automatically send the report to that entity," Ms. Jones explained at the annual meeting of the American Health Lawyers Association.

She added that the new program is "an alternative to, not a replacement for, the current querying service."

There will be a small charge to the facility for each person it registers, probably around $3 per practitioner, she said. Different entities can register the same practitioner.

Another change is a proposed regulation known as Section 1921, which will expand the data bank's reach, Ms. Jones continued.

"Section 1921 will expand the data that's in the data bank," Ms. Jones explained. "State licensing authorities must [now] report all adverse licensing actions about all practitioners," not just physicians and dentists.

That means that hospitals and other organizations can query the data bank on other health professionals such as nurses, respiratory therapists, and massage therapists, she said.

Another part of Section 1921 would require peer review organizations to report negative actions taken against individual practitioners.

However, she noted, quality improvement organizations would be exempt from that requirement under the proposed rule.

When it published the proposed rule earlier this year in the Federal Register, the Health Resources and Services Administration explained why it is exempting quality improvement organizations.

"First, the critical mission of the [quality improvement organization] program is its focus on maintaining collaborative relationships with providers and practitioners to improve the quality of health care services delivered to Medicare beneficiaries," the agency noted.

"The reporting of [quality improvement organization] sanction recommendations to the National Practitioner Data Bank will significantly interfere with the progress that has been made toward this goal and will substantially reduce the ability of quality improvement organizations to carry out their statutory and contractual obligations," according to the Health Resources and Services Administration.

The agency also expressed concern that requiring quality improvement organizations to report recommended sanctions to the data bank "may create misconceptions about the meaning of quality improvement organizations sanction recommendations," since they are only recommendations and may not always be acted on. The agency is still reviewing comments it has received on the proposed rule.

In addition to the new regulations that it is proposing, the data bank also has developed a compliance program to make sure that it is getting all the reports it should.

For example, data bank officials compare actions that have been documented on state licensing board Web sites with information that is in the data bank.

In addition, data bank staff look at newspapers, magazines, and public media "to see if we're missing something," Ms. Jones said.

PHILADELPHIA — A new service being offered by the National Practitioner Data Bank will make it easier for hospitals and other institutions to find out when a physician with privileges at their institution has had a data bank report filed on him or her by another entity.

The new program, called the Proactive Disclosure Service, is expected to start next spring, according to Shirley Jones, senior policy analyst at the Health Resources and Services Administration, Rockville, Md., the agency that runs the data bank.

The service allows the entity—a hospital or other facility—to register all practitioners who could potentially be subjects of data bank reports.

"Then, if the data bank gets a report on that practitioner, the data bank will automatically send the report to that entity," Ms. Jones explained at the annual meeting of the American Health Lawyers Association.

She added that the new program is "an alternative to, not a replacement for, the current querying service."

There will be a small charge to the facility for each person it registers, probably around $3 per practitioner, she said. Different entities can register the same practitioner.

Another change is a proposed regulation known as Section 1921, which will expand the data bank's reach, Ms. Jones continued.

"Section 1921 will expand the data that's in the data bank," Ms. Jones explained. "State licensing authorities must [now] report all adverse licensing actions about all practitioners," not just physicians and dentists.

That means that hospitals and other organizations can query the data bank on other health professionals such as nurses, respiratory therapists, and massage therapists, she said.

Another part of Section 1921 would require peer review organizations to report negative actions taken against individual practitioners.

However, she noted, quality improvement organizations would be exempt from that requirement under the proposed rule.

When it published the proposed rule earlier this year in the Federal Register, the Health Resources and Services Administration explained why it is exempting quality improvement organizations.

"First, the critical mission of the [quality improvement organization] program is its focus on maintaining collaborative relationships with providers and practitioners to improve the quality of health care services delivered to Medicare beneficiaries," the agency noted.

"The reporting of [quality improvement organization] sanction recommendations to the National Practitioner Data Bank will significantly interfere with the progress that has been made toward this goal and will substantially reduce the ability of quality improvement organizations to carry out their statutory and contractual obligations," according to the Health Resources and Services Administration.

The agency also expressed concern that requiring quality improvement organizations to report recommended sanctions to the data bank "may create misconceptions about the meaning of quality improvement organizations sanction recommendations," since they are only recommendations and may not always be acted on. The agency is still reviewing comments it has received on the proposed rule.

In addition to the new regulations that it is proposing, the data bank also has developed a compliance program to make sure that it is getting all the reports it should.

For example, data bank officials compare actions that have been documented on state licensing board Web sites with information that is in the data bank.

In addition, data bank staff look at newspapers, magazines, and public media "to see if we're missing something," Ms. Jones said.

Almost 50 million by 2050?

The number of Americans with diabetes may nearly triple by the year 2050, according to an article in the September issue of Diabetes Care. “We now project 48.3 million people with diagnosed diabetes in the U.S. in 2050,” up from 16.2 million in 2005, according to Dr. K.M. Venkat Narayan and colleagues at the Centers for Disease Control and Prevention. With projected increases in the population in the intervening years, the increase would mean the percentage of Americans with diagnosed diabetes would increase from 5.62% to 12%, the authors wrote. They noted that earlier projections suggested that there would be only 39 million people with diagnosed diabetes by 2050. “If incidence rates continue to rise, the impact on future numbers with diabetes, and consequent health care costs, will be much more devastating. Implementation of evidence-based primary prevention is thus an urgent national priority,” the authors said.

Grants Target Artificial Pancreas

The Juvenile Diabetes Research Foundation is issuing nearly $6 million in grants aimed at getting researchers closer to developing an artificial pancreas. “We believe that the new continuous glucose sensors will dramatically improve the ability of people with type 1 diabetes to control the wide fluctuations of glucose levels that, over time, lead to severe complications like heart attacks, kidney failure, amputations, and blindness,” said Dr. Richard Insel, the foundation's executive vice president of research. “These grants will help us better understand and quantify the benefits of technology-enabled glucose control, and take a big step toward an artificial pancreas.” The first year's funding for the Artificial Pancreas Project, which was launched in late 2005, includes a multisite clinical trial comparing health outcomes in patients with type 1 diabetes who use continuous glucose sensors with type 1 patients who do not use the sensors. The project also is funding the multisite Artificial Pancreas Consortium, which is working on algorithms for a closed-loop system linking a glucose sensor with an insulin pump.

Views on Medicare Part D

Most physicians agree that the Medicare Part D drug benefit is saving money for patients, but they see the law as too complicated, according to a poll commissioned by the Kaiser Family Foundation. Seventy-one percent of physicians surveyed somewhat or strongly agreed that the programs help people on Medicare save money, while 92% somewhat or strongly agreed that it is too complicated. And 64% of physicians agreed that it benefits private health plans and pharmaceutical companies too much, according to the results of the Kaiser survey. Physicians also reported that the program increased their day-to-day hassles. About 64% of physicians reported that the Medicare drug program put a lot or some burden on themselves or their staff, compared with 33% who reported not much or no burden associated with the Part D benefit. The survey, conducted between April and July, is based on a nationally representative sample of 834 office-based physicians involved in direct adult patient care.

Raising Paget's Disease Awareness

Officials at the National Institutes of Health are aiming to get seniors better informed about Paget's disease of bone by adding information on the condition to the agency's senior health Web site. The site—

www.NIHSeniorHealth.gov

Fewer Docs Accept Medicaid

The proportion of physicians who accept Medicaid patients has decreased in the last 10 years, according to a study by the Washington-based Center for Studying Health System Change. During 1996–1997, 13% of physicians reported no Medicaid revenue. By 2004, 15% said they did not accept Medicaid. Similarly, the percentage of physicians accepting no new Medicaid patients had stayed steady, at 19% in 1996, compared with 21% in 2004. That is a substantial difference from the numbers of physicians who in 2004 said they accept all new private-pay patients (71%) or all new Medicare patients (73%). The data come from the center's Community Tracking Study Physician Survey. The top reasons for not accepting new Medicaid patients: inadequate reimbursement, billing and paperwork hassles, and delayed reimbursement.

Almost 50 million by 2050?

The number of Americans with diabetes may nearly triple by the year 2050, according to an article in the September issue of Diabetes Care. “We now project 48.3 million people with diagnosed diabetes in the U.S. in 2050,” up from 16.2 million in 2005, according to Dr. K.M. Venkat Narayan and colleagues at the Centers for Disease Control and Prevention. With projected increases in the population in the intervening years, the increase would mean the percentage of Americans with diagnosed diabetes would increase from 5.62% to 12%, the authors wrote. They noted that earlier projections suggested that there would be only 39 million people with diagnosed diabetes by 2050. “If incidence rates continue to rise, the impact on future numbers with diabetes, and consequent health care costs, will be much more devastating. Implementation of evidence-based primary prevention is thus an urgent national priority,” the authors said.

Grants Target Artificial Pancreas

The Juvenile Diabetes Research Foundation is issuing nearly $6 million in grants aimed at getting researchers closer to developing an artificial pancreas. “We believe that the new continuous glucose sensors will dramatically improve the ability of people with type 1 diabetes to control the wide fluctuations of glucose levels that, over time, lead to severe complications like heart attacks, kidney failure, amputations, and blindness,” said Dr. Richard Insel, the foundation's executive vice president of research. “These grants will help us better understand and quantify the benefits of technology-enabled glucose control, and take a big step toward an artificial pancreas.” The first year's funding for the Artificial Pancreas Project, which was launched in late 2005, includes a multisite clinical trial comparing health outcomes in patients with type 1 diabetes who use continuous glucose sensors with type 1 patients who do not use the sensors. The project also is funding the multisite Artificial Pancreas Consortium, which is working on algorithms for a closed-loop system linking a glucose sensor with an insulin pump.

Views on Medicare Part D

Most physicians agree that the Medicare Part D drug benefit is saving money for patients, but they see the law as too complicated, according to a poll commissioned by the Kaiser Family Foundation. Seventy-one percent of physicians surveyed somewhat or strongly agreed that the programs help people on Medicare save money, while 92% somewhat or strongly agreed that it is too complicated. And 64% of physicians agreed that it benefits private health plans and pharmaceutical companies too much, according to the results of the Kaiser survey. Physicians also reported that the program increased their day-to-day hassles. About 64% of physicians reported that the Medicare drug program put a lot or some burden on themselves or their staff, compared with 33% who reported not much or no burden associated with the Part D benefit. The survey, conducted between April and July, is based on a nationally representative sample of 834 office-based physicians involved in direct adult patient care.

Raising Paget's Disease Awareness

Officials at the National Institutes of Health are aiming to get seniors better informed about Paget's disease of bone by adding information on the condition to the agency's senior health Web site. The site—

www.NIHSeniorHealth.gov

Fewer Docs Accept Medicaid

The proportion of physicians who accept Medicaid patients has decreased in the last 10 years, according to a study by the Washington-based Center for Studying Health System Change. During 1996–1997, 13% of physicians reported no Medicaid revenue. By 2004, 15% said they did not accept Medicaid. Similarly, the percentage of physicians accepting no new Medicaid patients had stayed steady, at 19% in 1996, compared with 21% in 2004. That is a substantial difference from the numbers of physicians who in 2004 said they accept all new private-pay patients (71%) or all new Medicare patients (73%). The data come from the center's Community Tracking Study Physician Survey. The top reasons for not accepting new Medicaid patients: inadequate reimbursement, billing and paperwork hassles, and delayed reimbursement.

Almost 50 million by 2050?

The number of Americans with diabetes may nearly triple by the year 2050, according to an article in the September issue of Diabetes Care. “We now project 48.3 million people with diagnosed diabetes in the U.S. in 2050,” up from 16.2 million in 2005, according to Dr. K.M. Venkat Narayan and colleagues at the Centers for Disease Control and Prevention. With projected increases in the population in the intervening years, the increase would mean the percentage of Americans with diagnosed diabetes would increase from 5.62% to 12%, the authors wrote. They noted that earlier projections suggested that there would be only 39 million people with diagnosed diabetes by 2050. “If incidence rates continue to rise, the impact on future numbers with diabetes, and consequent health care costs, will be much more devastating. Implementation of evidence-based primary prevention is thus an urgent national priority,” the authors said.

Grants Target Artificial Pancreas

The Juvenile Diabetes Research Foundation is issuing nearly $6 million in grants aimed at getting researchers closer to developing an artificial pancreas. “We believe that the new continuous glucose sensors will dramatically improve the ability of people with type 1 diabetes to control the wide fluctuations of glucose levels that, over time, lead to severe complications like heart attacks, kidney failure, amputations, and blindness,” said Dr. Richard Insel, the foundation's executive vice president of research. “These grants will help us better understand and quantify the benefits of technology-enabled glucose control, and take a big step toward an artificial pancreas.” The first year's funding for the Artificial Pancreas Project, which was launched in late 2005, includes a multisite clinical trial comparing health outcomes in patients with type 1 diabetes who use continuous glucose sensors with type 1 patients who do not use the sensors. The project also is funding the multisite Artificial Pancreas Consortium, which is working on algorithms for a closed-loop system linking a glucose sensor with an insulin pump.

Views on Medicare Part D

Most physicians agree that the Medicare Part D drug benefit is saving money for patients, but they see the law as too complicated, according to a poll commissioned by the Kaiser Family Foundation. Seventy-one percent of physicians surveyed somewhat or strongly agreed that the programs help people on Medicare save money, while 92% somewhat or strongly agreed that it is too complicated. And 64% of physicians agreed that it benefits private health plans and pharmaceutical companies too much, according to the results of the Kaiser survey. Physicians also reported that the program increased their day-to-day hassles. About 64% of physicians reported that the Medicare drug program put a lot or some burden on themselves or their staff, compared with 33% who reported not much or no burden associated with the Part D benefit. The survey, conducted between April and July, is based on a nationally representative sample of 834 office-based physicians involved in direct adult patient care.

Raising Paget's Disease Awareness

Officials at the National Institutes of Health are aiming to get seniors better informed about Paget's disease of bone by adding information on the condition to the agency's senior health Web site. The site—

www.NIHSeniorHealth.gov

Fewer Docs Accept Medicaid

The proportion of physicians who accept Medicaid patients has decreased in the last 10 years, according to a study by the Washington-based Center for Studying Health System Change. During 1996–1997, 13% of physicians reported no Medicaid revenue. By 2004, 15% said they did not accept Medicaid. Similarly, the percentage of physicians accepting no new Medicaid patients had stayed steady, at 19% in 1996, compared with 21% in 2004. That is a substantial difference from the numbers of physicians who in 2004 said they accept all new private-pay patients (71%) or all new Medicare patients (73%). The data come from the center's Community Tracking Study Physician Survey. The top reasons for not accepting new Medicaid patients: inadequate reimbursement, billing and paperwork hassles, and delayed reimbursement.

BALTIMORE — Some of the physicians who embrace concierge care are ideologues who want the government and insurance companies to stop interfering in the doctor-patient relationship. And others? They're in it for the money and the lifestyle, John R. Marquis said at a meeting of the American Society of Law, Medicine, and Ethics.

Another reason physicians give is to improve patient care, said Mr. Marquis, a partner in a Holland, Mich., law firm. But there are two levels to the patient care issue.

“Some say, 'I could practice better medicine if I spent more time with patients.' But there has been no proof of that whatsoever,” said Mr. Marquis, who helps physicians set up concierge practices. He added that from an ethical perspective, physicians are not supposed to imply that concierge care will mean better care for their patients. Others profess the desire to provide better preventive care, Mr. Marquis said, noting that, to him, this seemed like a legitimate reason for moving to concierge care.

“Physicians don't get paid for doing preventive care, generally speaking. You'd be surprised at the number of physicians who say, 'I really would love to see healthy patients, because I have a lot to say to them. I'd like to plan their diet, their lifestyle, get them on nonsmoking programs, and I want to be part of their lifestyle,” he said at the meeting cosponsored by the University of Maryland.

According to Mr. Marquis, there are two basic models of concierge practice. The first, practiced by the ideologues, is a “fee-for-care” model, in which the physician charges a set fee—say, $100 per month—in exchange for giving patients access to all the primary care they need, including sick visits, physicals, immunizations, and lab work. These physicians opt out of Medicare and don't bill insurance, although they may remain on some managed care panels.

The second model, used more by physicians interested in increasing their incomes, is a “fee-for-noncovered-service” model, in which the doctor charges patients a per-visit fee but also charges an annual fee for services not covered by Medicare, such as a yearly physical. “These people are driven more by money,” said Mr. Marquis.

Proponents also say that the type of intensive medical care provided is very good for people with chronic illnesses, and that the increased income ultimately will make medicine more attractive and lead more people toward a medical profession.

BALTIMORE — Some of the physicians who embrace concierge care are ideologues who want the government and insurance companies to stop interfering in the doctor-patient relationship. And others? They're in it for the money and the lifestyle, John R. Marquis said at a meeting of the American Society of Law, Medicine, and Ethics.

Another reason physicians give is to improve patient care, said Mr. Marquis, a partner in a Holland, Mich., law firm. But there are two levels to the patient care issue.

“Some say, 'I could practice better medicine if I spent more time with patients.' But there has been no proof of that whatsoever,” said Mr. Marquis, who helps physicians set up concierge practices. He added that from an ethical perspective, physicians are not supposed to imply that concierge care will mean better care for their patients. Others profess the desire to provide better preventive care, Mr. Marquis said, noting that, to him, this seemed like a legitimate reason for moving to concierge care.

“Physicians don't get paid for doing preventive care, generally speaking. You'd be surprised at the number of physicians who say, 'I really would love to see healthy patients, because I have a lot to say to them. I'd like to plan their diet, their lifestyle, get them on nonsmoking programs, and I want to be part of their lifestyle,” he said at the meeting cosponsored by the University of Maryland.

According to Mr. Marquis, there are two basic models of concierge practice. The first, practiced by the ideologues, is a “fee-for-care” model, in which the physician charges a set fee—say, $100 per month—in exchange for giving patients access to all the primary care they need, including sick visits, physicals, immunizations, and lab work. These physicians opt out of Medicare and don't bill insurance, although they may remain on some managed care panels.

The second model, used more by physicians interested in increasing their incomes, is a “fee-for-noncovered-service” model, in which the doctor charges patients a per-visit fee but also charges an annual fee for services not covered by Medicare, such as a yearly physical. “These people are driven more by money,” said Mr. Marquis.

Proponents also say that the type of intensive medical care provided is very good for people with chronic illnesses, and that the increased income ultimately will make medicine more attractive and lead more people toward a medical profession.

BALTIMORE — Some of the physicians who embrace concierge care are ideologues who want the government and insurance companies to stop interfering in the doctor-patient relationship. And others? They're in it for the money and the lifestyle, John R. Marquis said at a meeting of the American Society of Law, Medicine, and Ethics.

Another reason physicians give is to improve patient care, said Mr. Marquis, a partner in a Holland, Mich., law firm. But there are two levels to the patient care issue.

“Some say, 'I could practice better medicine if I spent more time with patients.' But there has been no proof of that whatsoever,” said Mr. Marquis, who helps physicians set up concierge practices. He added that from an ethical perspective, physicians are not supposed to imply that concierge care will mean better care for their patients. Others profess the desire to provide better preventive care, Mr. Marquis said, noting that, to him, this seemed like a legitimate reason for moving to concierge care.

“Physicians don't get paid for doing preventive care, generally speaking. You'd be surprised at the number of physicians who say, 'I really would love to see healthy patients, because I have a lot to say to them. I'd like to plan their diet, their lifestyle, get them on nonsmoking programs, and I want to be part of their lifestyle,” he said at the meeting cosponsored by the University of Maryland.

According to Mr. Marquis, there are two basic models of concierge practice. The first, practiced by the ideologues, is a “fee-for-care” model, in which the physician charges a set fee—say, $100 per month—in exchange for giving patients access to all the primary care they need, including sick visits, physicals, immunizations, and lab work. These physicians opt out of Medicare and don't bill insurance, although they may remain on some managed care panels.

The second model, used more by physicians interested in increasing their incomes, is a “fee-for-noncovered-service” model, in which the doctor charges patients a per-visit fee but also charges an annual fee for services not covered by Medicare, such as a yearly physical. “These people are driven more by money,” said Mr. Marquis.

Proponents also say that the type of intensive medical care provided is very good for people with chronic illnesses, and that the increased income ultimately will make medicine more attractive and lead more people toward a medical profession.

BALTIMORE — Targeting medicines at particular racial categories “is a misguided approach, and what we should be pursuing is attribute-based medicine,” Sharona Hoffman said at the annual meeting of the American Society of Law, Medicine, and Ethics.

One example of a medicine targeted at racial categories is BiDil (fixed-dose isosorbide dinitrate and hydralazine), an antihypertensive drug that was approved specifically for use in blacks. Some experts have concluded that a good response to BiDil has more to do with attributes and genes than it does with racial identity.

Patient attributes that might be considered relevant for assessing disease vulnerability or treatment responses include genetic variations or alleles that might be more common for people who are of one ancestral origin rather than others but could still cross population lines. “Then there are other factors such as diet, exercise, stress level, and exposure to toxins” that play into treatment response, said Ms. Hoffman, a professor of law at Case Western Reserve University in Cleveland.

“The Human Genome Project showed us that race is not a biologically valid or genetically valid concept, and therefore the emergence of 'race-based' medicine is both perplexing and troubling,” she said at the meeting, which was cosponsored by the University of Maryland.

“Race doesn't mean much of anything” from a genetic perspective because “99.9% of genes are identical for all humans,” and in the remaining 0.1%, 90%–95% of genetic variations are found at equal rates in every population.

Society also has difficulty defining race, with legal definitions of race varying from one state to another, Ms. Hoffman said. The race categories listed in the U.S. Census also change every decade. Almost 7 million people checked off more than one race in the 2000 census, she noted.

“If you ask people to self-identify, they may say they're African American when they are really of mixed race. And visual observation is even more misleading.”

In addition to these problems, using “race-based” medicine may exacerbate health disparities, because “it's possible doctors may try to specialize in treating blacks or whites,” said Ms. Hoffman. That may violate federal or state antidiscrimination laws.

Instead of pursuing race-based protocols, Ms. Hoffman recommended designing attribute-based trial protocols, and having institutional review boards and scientific review boards subject them to special scrutiny.

“Consider the genetic variations and the psychosocial, economic, cultural, environmental, and other factors, which you can measure or ask about—stress, diet, exercise, exposure to toxins, and cultural and religious barriers to treatment compliance,” she said. “Maybe people aren't doing well because they are not following the protocol—because they either don't understand it [due to] a language barrier, or they have religious beliefs that prevent them from doing some of the things you need them to do.

“Don't use skin color as a proxy. What questions do you need to ask? Do you need to do further genetic testing?” she said.

Also, be aware of the limits of self-identification or identification through visual observation. “It's very hard to tell what ancestry people have if you don't ask specific questions,” Ms. Hoffman said.

BALTIMORE — Targeting medicines at particular racial categories “is a misguided approach, and what we should be pursuing is attribute-based medicine,” Sharona Hoffman said at the annual meeting of the American Society of Law, Medicine, and Ethics.

One example of a medicine targeted at racial categories is BiDil (fixed-dose isosorbide dinitrate and hydralazine), an antihypertensive drug that was approved specifically for use in blacks. Some experts have concluded that a good response to BiDil has more to do with attributes and genes than it does with racial identity.

Patient attributes that might be considered relevant for assessing disease vulnerability or treatment responses include genetic variations or alleles that might be more common for people who are of one ancestral origin rather than others but could still cross population lines. “Then there are other factors such as diet, exercise, stress level, and exposure to toxins” that play into treatment response, said Ms. Hoffman, a professor of law at Case Western Reserve University in Cleveland.

“The Human Genome Project showed us that race is not a biologically valid or genetically valid concept, and therefore the emergence of 'race-based' medicine is both perplexing and troubling,” she said at the meeting, which was cosponsored by the University of Maryland.

“Race doesn't mean much of anything” from a genetic perspective because “99.9% of genes are identical for all humans,” and in the remaining 0.1%, 90%–95% of genetic variations are found at equal rates in every population.

Society also has difficulty defining race, with legal definitions of race varying from one state to another, Ms. Hoffman said. The race categories listed in the U.S. Census also change every decade. Almost 7 million people checked off more than one race in the 2000 census, she noted.

“If you ask people to self-identify, they may say they're African American when they are really of mixed race. And visual observation is even more misleading.”

In addition to these problems, using “race-based” medicine may exacerbate health disparities, because “it's possible doctors may try to specialize in treating blacks or whites,” said Ms. Hoffman. That may violate federal or state antidiscrimination laws.

Instead of pursuing race-based protocols, Ms. Hoffman recommended designing attribute-based trial protocols, and having institutional review boards and scientific review boards subject them to special scrutiny.

“Consider the genetic variations and the psychosocial, economic, cultural, environmental, and other factors, which you can measure or ask about—stress, diet, exercise, exposure to toxins, and cultural and religious barriers to treatment compliance,” she said. “Maybe people aren't doing well because they are not following the protocol—because they either don't understand it [due to] a language barrier, or they have religious beliefs that prevent them from doing some of the things you need them to do.

“Don't use skin color as a proxy. What questions do you need to ask? Do you need to do further genetic testing?” she said.

Also, be aware of the limits of self-identification or identification through visual observation. “It's very hard to tell what ancestry people have if you don't ask specific questions,” Ms. Hoffman said.

BALTIMORE — Targeting medicines at particular racial categories “is a misguided approach, and what we should be pursuing is attribute-based medicine,” Sharona Hoffman said at the annual meeting of the American Society of Law, Medicine, and Ethics.

One example of a medicine targeted at racial categories is BiDil (fixed-dose isosorbide dinitrate and hydralazine), an antihypertensive drug that was approved specifically for use in blacks. Some experts have concluded that a good response to BiDil has more to do with attributes and genes than it does with racial identity.

Patient attributes that might be considered relevant for assessing disease vulnerability or treatment responses include genetic variations or alleles that might be more common for people who are of one ancestral origin rather than others but could still cross population lines. “Then there are other factors such as diet, exercise, stress level, and exposure to toxins” that play into treatment response, said Ms. Hoffman, a professor of law at Case Western Reserve University in Cleveland.

“The Human Genome Project showed us that race is not a biologically valid or genetically valid concept, and therefore the emergence of 'race-based' medicine is both perplexing and troubling,” she said at the meeting, which was cosponsored by the University of Maryland.

“Race doesn't mean much of anything” from a genetic perspective because “99.9% of genes are identical for all humans,” and in the remaining 0.1%, 90%–95% of genetic variations are found at equal rates in every population.

Society also has difficulty defining race, with legal definitions of race varying from one state to another, Ms. Hoffman said. The race categories listed in the U.S. Census also change every decade. Almost 7 million people checked off more than one race in the 2000 census, she noted.

“If you ask people to self-identify, they may say they're African American when they are really of mixed race. And visual observation is even more misleading.”

In addition to these problems, using “race-based” medicine may exacerbate health disparities, because “it's possible doctors may try to specialize in treating blacks or whites,” said Ms. Hoffman. That may violate federal or state antidiscrimination laws.

Instead of pursuing race-based protocols, Ms. Hoffman recommended designing attribute-based trial protocols, and having institutional review boards and scientific review boards subject them to special scrutiny.

“Consider the genetic variations and the psychosocial, economic, cultural, environmental, and other factors, which you can measure or ask about—stress, diet, exercise, exposure to toxins, and cultural and religious barriers to treatment compliance,” she said. “Maybe people aren't doing well because they are not following the protocol—because they either don't understand it [due to] a language barrier, or they have religious beliefs that prevent them from doing some of the things you need them to do.

“Don't use skin color as a proxy. What questions do you need to ask? Do you need to do further genetic testing?” she said.

Also, be aware of the limits of self-identification or identification through visual observation. “It's very hard to tell what ancestry people have if you don't ask specific questions,” Ms. Hoffman said.

PHILADELPHIA — A new service being offered by the National Practitioner Data Bank will make it easier for hospitals and other institutions to find out when a physician with privileges at their institution has had a data bank report filed on him or her by another entity.

The new program, called the Proactive Disclosure Service, is expected to start next spring, according to Shirley Jones, senior policy analyst at the Health Resources and Services Administration, Rockville, Md., which runs the data bank. The service allows the entity—a hospital or other facility—to register all practitioners who could potentially be subjects of data bank reports. “Then, if the data bank gets a report on that practitioner, the data bank will automatically send the report to that entity,” she explained, adding that the new program is “an alternative to, not a replacement for, the current querying service.” Ms. Jones spoke at the annual meeting of the American Health Lawyers Association.

There will be a small charge to the facility for each person it registers, probably around $3 per practitioner, she said. Different entities can register the same practitioner.

Another change is a proposed regulation known as Section 1921, which will expand the data bank's reach, Ms. Jones continued.

“Section 1921 will expand the data that's in the data bank,” she said. “State licensing authorities must [now] report all adverse licensing actions about all practitioners,” not just physicians and dentists. That means hospitals and other organizations can query the data bank on other health professionals such as nurses, respiratory therapists, and massage therapists, she said.

Another part of Section 1921 would require peer review organizations to report negative actions taken against individual practitioners. However, she noted, quality improvement organizations (QIOs) would be exempt from that requirement under the proposed rule.

When it published the proposed rule earlier this year in the Federal Register, the Health Resources and Services Administration explained why it is exempting QIOs. “First, the critical mission of the QIO program is its focus on maintaining collaborative relationships with providers and practitioners to improve the quality of health care services delivered to Medicare beneficiaries,” the agency noted. “The reporting of QIO sanction recommendations to the National Practitioner Data Bank will significantly interfere with the progress that has been made toward this goal and will substantially reduce the ability of QIOs to carry out their statutory and contractual obligations.”

The agency also expressed concern that requiring QIOs to report recommended sanctions to the data bank “may create misconceptions about the meaning of QIO sanction recommendations,” since they are only recommendations and may not always be acted on. The agency is still reviewing comments it has received on the proposed rule.

In addition to the new regulations it is proposing, the data bank also has developed a compliance program to make sure that it is getting all the reports it should. Data bank officials compare actions that have been documented on state licensing board Web sites with what is in the data bank; they also look at newspapers, magazines, and public media “to see if we're missing something,” Ms. Jones said.

PHILADELPHIA — A new service being offered by the National Practitioner Data Bank will make it easier for hospitals and other institutions to find out when a physician with privileges at their institution has had a data bank report filed on him or her by another entity.

The new program, called the Proactive Disclosure Service, is expected to start next spring, according to Shirley Jones, senior policy analyst at the Health Resources and Services Administration, Rockville, Md., which runs the data bank. The service allows the entity—a hospital or other facility—to register all practitioners who could potentially be subjects of data bank reports. “Then, if the data bank gets a report on that practitioner, the data bank will automatically send the report to that entity,” she explained, adding that the new program is “an alternative to, not a replacement for, the current querying service.” Ms. Jones spoke at the annual meeting of the American Health Lawyers Association.

There will be a small charge to the facility for each person it registers, probably around $3 per practitioner, she said. Different entities can register the same practitioner.

Another change is a proposed regulation known as Section 1921, which will expand the data bank's reach, Ms. Jones continued.

“Section 1921 will expand the data that's in the data bank,” she said. “State licensing authorities must [now] report all adverse licensing actions about all practitioners,” not just physicians and dentists. That means hospitals and other organizations can query the data bank on other health professionals such as nurses, respiratory therapists, and massage therapists, she said.

Another part of Section 1921 would require peer review organizations to report negative actions taken against individual practitioners. However, she noted, quality improvement organizations (QIOs) would be exempt from that requirement under the proposed rule.

When it published the proposed rule earlier this year in the Federal Register, the Health Resources and Services Administration explained why it is exempting QIOs. “First, the critical mission of the QIO program is its focus on maintaining collaborative relationships with providers and practitioners to improve the quality of health care services delivered to Medicare beneficiaries,” the agency noted. “The reporting of QIO sanction recommendations to the National Practitioner Data Bank will significantly interfere with the progress that has been made toward this goal and will substantially reduce the ability of QIOs to carry out their statutory and contractual obligations.”

The agency also expressed concern that requiring QIOs to report recommended sanctions to the data bank “may create misconceptions about the meaning of QIO sanction recommendations,” since they are only recommendations and may not always be acted on. The agency is still reviewing comments it has received on the proposed rule.

In addition to the new regulations it is proposing, the data bank also has developed a compliance program to make sure that it is getting all the reports it should. Data bank officials compare actions that have been documented on state licensing board Web sites with what is in the data bank; they also look at newspapers, magazines, and public media “to see if we're missing something,” Ms. Jones said.

PHILADELPHIA — A new service being offered by the National Practitioner Data Bank will make it easier for hospitals and other institutions to find out when a physician with privileges at their institution has had a data bank report filed on him or her by another entity.

The new program, called the Proactive Disclosure Service, is expected to start next spring, according to Shirley Jones, senior policy analyst at the Health Resources and Services Administration, Rockville, Md., which runs the data bank. The service allows the entity—a hospital or other facility—to register all practitioners who could potentially be subjects of data bank reports. “Then, if the data bank gets a report on that practitioner, the data bank will automatically send the report to that entity,” she explained, adding that the new program is “an alternative to, not a replacement for, the current querying service.” Ms. Jones spoke at the annual meeting of the American Health Lawyers Association.

There will be a small charge to the facility for each person it registers, probably around $3 per practitioner, she said. Different entities can register the same practitioner.

Another change is a proposed regulation known as Section 1921, which will expand the data bank's reach, Ms. Jones continued.

“Section 1921 will expand the data that's in the data bank,” she said. “State licensing authorities must [now] report all adverse licensing actions about all practitioners,” not just physicians and dentists. That means hospitals and other organizations can query the data bank on other health professionals such as nurses, respiratory therapists, and massage therapists, she said.

Another part of Section 1921 would require peer review organizations to report negative actions taken against individual practitioners. However, she noted, quality improvement organizations (QIOs) would be exempt from that requirement under the proposed rule.

When it published the proposed rule earlier this year in the Federal Register, the Health Resources and Services Administration explained why it is exempting QIOs. “First, the critical mission of the QIO program is its focus on maintaining collaborative relationships with providers and practitioners to improve the quality of health care services delivered to Medicare beneficiaries,” the agency noted. “The reporting of QIO sanction recommendations to the National Practitioner Data Bank will significantly interfere with the progress that has been made toward this goal and will substantially reduce the ability of QIOs to carry out their statutory and contractual obligations.”

The agency also expressed concern that requiring QIOs to report recommended sanctions to the data bank “may create misconceptions about the meaning of QIO sanction recommendations,” since they are only recommendations and may not always be acted on. The agency is still reviewing comments it has received on the proposed rule.

In addition to the new regulations it is proposing, the data bank also has developed a compliance program to make sure that it is getting all the reports it should. Data bank officials compare actions that have been documented on state licensing board Web sites with what is in the data bank; they also look at newspapers, magazines, and public media “to see if we're missing something,” Ms. Jones said.

BALTIMORE — Targeting medicines at particular racial categories “is a misguided approach, and what we should be pursuing is attribute-based medicine,” Sharona Hoffman said at the annual meeting of the American Society of Law, Medicine, and Ethics.

One example of a medicine targeted at racial categories is BiDil (fixed-dose isosorbide dinitrate and hydralazine), an antihypertensive drug that was approved specifically for use in blacks.

Some experts have concluded that a good response to BiDil has more to do with attributes and genes than it does with racial identity.

Patient attributes that might be considered relevant for assessing disease vulnerability or treatment responses include genetic variations or alleles that might be more common for people who are of one ancestral origin rather than others but could still cross population lines.

“Then there are other factors such as diet, exercise, stress level, and exposure to toxins” that play into treatment response, said Ms. Hoffman, a professor of law at Case Western Reserve University in Cleveland.

“The Human Genome Project showed us that race is not a biologically valid or genetically valid concept, and therefore the emergence of 'race-based' medicine is both perplexing and troubling,” she said at the meeting, which was cosponsored by the University of Maryland.

“Race doesn't mean much of anything” from a genetic perspective because “99.9% of genes are identical for all humans,” and in the remaining 0.1%, 90%–95% of genetic variations are found at equal rates in every population.

Society also has difficulty defining race, with legal definitions of race varying from one state to another, Ms. Hoffman said. The race categories listed in the U.S. Census also change every decade. Almost 7 million people checked off more than one race in the 2000 census, she noted.

“If you ask people to self-identify, they may say they're African American when they are really of mixed race. And visual observation is even more misleading.”

In addition to these problems, using “race-based” medicine may exacerbate health disparities, because “it's possible doctors may try to specialize in treating blacks or whites,” said Ms. Hoffman. That may violate federal or state antidiscrimination laws.

Instead of pursuing race-based protocols, Ms. Hoffman recommended designing attribute-based trial protocols, and having institutional review boards and scientific review boards subject them to special scrutiny.

“Consider the genetic variations and the psychosocial, economic, cultural, environmental, and other factors, which you can measure or ask about—stress, diet, exercise, exposure to toxins, and cultural and religious barriers to treatment compliance,” she said. “Maybe people aren't doing well because they are not following the protocol—because they either don't understand it [due to] a language barrier, or they have religious beliefs that prevent them from doing some of the things you need them to do.

“Don't use skin color as a proxy. What questions do you need to ask? Do you need to do further genetic testing?” she said.

Also, be aware of the limits of self-identification or identification through visual observation. “It's very hard to tell what ancestry people have if you don't ask specific questions,” Ms. Hoffman said.

BALTIMORE — Targeting medicines at particular racial categories “is a misguided approach, and what we should be pursuing is attribute-based medicine,” Sharona Hoffman said at the annual meeting of the American Society of Law, Medicine, and Ethics.

One example of a medicine targeted at racial categories is BiDil (fixed-dose isosorbide dinitrate and hydralazine), an antihypertensive drug that was approved specifically for use in blacks.

Some experts have concluded that a good response to BiDil has more to do with attributes and genes than it does with racial identity.

Patient attributes that might be considered relevant for assessing disease vulnerability or treatment responses include genetic variations or alleles that might be more common for people who are of one ancestral origin rather than others but could still cross population lines.

“Then there are other factors such as diet, exercise, stress level, and exposure to toxins” that play into treatment response, said Ms. Hoffman, a professor of law at Case Western Reserve University in Cleveland.

“The Human Genome Project showed us that race is not a biologically valid or genetically valid concept, and therefore the emergence of 'race-based' medicine is both perplexing and troubling,” she said at the meeting, which was cosponsored by the University of Maryland.

“Race doesn't mean much of anything” from a genetic perspective because “99.9% of genes are identical for all humans,” and in the remaining 0.1%, 90%–95% of genetic variations are found at equal rates in every population.

Society also has difficulty defining race, with legal definitions of race varying from one state to another, Ms. Hoffman said. The race categories listed in the U.S. Census also change every decade. Almost 7 million people checked off more than one race in the 2000 census, she noted.

“If you ask people to self-identify, they may say they're African American when they are really of mixed race. And visual observation is even more misleading.”

In addition to these problems, using “race-based” medicine may exacerbate health disparities, because “it's possible doctors may try to specialize in treating blacks or whites,” said Ms. Hoffman. That may violate federal or state antidiscrimination laws.

Instead of pursuing race-based protocols, Ms. Hoffman recommended designing attribute-based trial protocols, and having institutional review boards and scientific review boards subject them to special scrutiny.

“Consider the genetic variations and the psychosocial, economic, cultural, environmental, and other factors, which you can measure or ask about—stress, diet, exercise, exposure to toxins, and cultural and religious barriers to treatment compliance,” she said. “Maybe people aren't doing well because they are not following the protocol—because they either don't understand it [due to] a language barrier, or they have religious beliefs that prevent them from doing some of the things you need them to do.

“Don't use skin color as a proxy. What questions do you need to ask? Do you need to do further genetic testing?” she said.

Also, be aware of the limits of self-identification or identification through visual observation. “It's very hard to tell what ancestry people have if you don't ask specific questions,” Ms. Hoffman said.

BALTIMORE — Targeting medicines at particular racial categories “is a misguided approach, and what we should be pursuing is attribute-based medicine,” Sharona Hoffman said at the annual meeting of the American Society of Law, Medicine, and Ethics.

One example of a medicine targeted at racial categories is BiDil (fixed-dose isosorbide dinitrate and hydralazine), an antihypertensive drug that was approved specifically for use in blacks.

Some experts have concluded that a good response to BiDil has more to do with attributes and genes than it does with racial identity.

Patient attributes that might be considered relevant for assessing disease vulnerability or treatment responses include genetic variations or alleles that might be more common for people who are of one ancestral origin rather than others but could still cross population lines.

“Then there are other factors such as diet, exercise, stress level, and exposure to toxins” that play into treatment response, said Ms. Hoffman, a professor of law at Case Western Reserve University in Cleveland.

“The Human Genome Project showed us that race is not a biologically valid or genetically valid concept, and therefore the emergence of 'race-based' medicine is both perplexing and troubling,” she said at the meeting, which was cosponsored by the University of Maryland.

“Race doesn't mean much of anything” from a genetic perspective because “99.9% of genes are identical for all humans,” and in the remaining 0.1%, 90%–95% of genetic variations are found at equal rates in every population.

Society also has difficulty defining race, with legal definitions of race varying from one state to another, Ms. Hoffman said. The race categories listed in the U.S. Census also change every decade. Almost 7 million people checked off more than one race in the 2000 census, she noted.

“If you ask people to self-identify, they may say they're African American when they are really of mixed race. And visual observation is even more misleading.”

In addition to these problems, using “race-based” medicine may exacerbate health disparities, because “it's possible doctors may try to specialize in treating blacks or whites,” said Ms. Hoffman. That may violate federal or state antidiscrimination laws.

Instead of pursuing race-based protocols, Ms. Hoffman recommended designing attribute-based trial protocols, and having institutional review boards and scientific review boards subject them to special scrutiny.

“Consider the genetic variations and the psychosocial, economic, cultural, environmental, and other factors, which you can measure or ask about—stress, diet, exercise, exposure to toxins, and cultural and religious barriers to treatment compliance,” she said. “Maybe people aren't doing well because they are not following the protocol—because they either don't understand it [due to] a language barrier, or they have religious beliefs that prevent them from doing some of the things you need them to do.

“Don't use skin color as a proxy. What questions do you need to ask? Do you need to do further genetic testing?” she said.

Also, be aware of the limits of self-identification or identification through visual observation. “It's very hard to tell what ancestry people have if you don't ask specific questions,” Ms. Hoffman said.

WASHINGTON — The mumps outbreak that occurred in Iowa earlier this year is not necessarily the end of the illness in the United States, Dr. Anne Schuchat said at a press briefing sponsored by the National Foundation for Infectious Diseases.

The Iowa outbreak was the biggest in 20 years, “but that doesn't mean it's the last time we'll be seeing mumps,” said Dr. Schuchat, who is director of the National Immunization Program at the Centers for Disease Control and Prevention, Atlanta.

The mumps vaccine was first licensed in 1967 and has been very successful for the most part, said Dr. Schuchat. But that changed in March 2006, when the outbreak began; Iowa had more than 200 cases, “which was almost as many cases as would [normally] have been recorded throughout the entire United States.”

By June 20th, Iowa had 1,921 reported cases; by early July, a total of 4,600 cases had been reported nationwide, she added. Much of the outbreak occurred in eight states: Iowa, Kansas, Nebraska, South Dakota, Wisconsin, Illinois, Missouri, and Pennsylvania.

The clinical illness involved in the outbreak was primarily mild: 80% of the cases featured parotitis, and there were a few cases of meningitis, 59 cases of orchitis, and more than 40 hospitalizations. No deaths were confirmed with the outbreak.

Although there are no simple answers to what caused the outbreak, investigators think it may have begun with an unrecognized importation, possibly from the United Kingdom, which had a large mumps outbreak in 2004–2005 involving about 70,000 cases. “The strain that is circulating in our mumps outbreak is identical to the strain from [the United Kingdom], but that strain is also common in a number of other places where mumps vaccination is not as strong as we have here in the United States,” Dr. Schuchat said.

The Iowa outbreak started with a group of college students, and may have been helped to spread by the college student lifestyle, said Dr. Schuchat. “I don't like to think about what happens in colleges, but we know the way people live in college and the way they socialize can lead to high transmission of infections.”

In addition, “we also know college students in America have a lower two-dose vaccine coverage than do [students in] high schools or elementary schools,” she said. “That's just a fact of life because we changed our recommendations for the two-dose schedule in 1989, and had pretty good follow-up in terms of school entry, but college students were older and didn't necessarily get that second dose before they went off to college.”

Delayed recognition of the outbreak also may have given it a chance to take off and spread to a lot of colleges and states, Dr. Schuchat continued. “Why did we have delayed recognition? [This occurred] partly because physicians and parents and kids aren't that familiar with mumps any more, and partly because some of the presentations were atypical. They weren't that jaw swelling that people know; there were other respiratory presentations.”

Another possible factor in the spread of the outbreak is the overall effectiveness of the vaccine itself. “The vaccine is good, but not great,” she said. “When you get two doses of mumps vaccine, we think 90% of people are protected, but it's not 100%. So 10% of people, even those who have good immune systems and get the most vaccine, will still be vulnerable to mumps if they get exposed to the virus.”

Dr. Schuchat stressed that the outbreak could have been much worse. “We have a very high measles/mumps/rubella vaccine coverage level, and the vaccine effectiveness of the two-dose schedule probably prevented thousands and thousands of cases.”

Investigators also think the disease was milder than it might otherwise have been, “because it was occurring in people who had one or two doses and may have not gotten the more severe forms of mumps even though they were adults and in an age group where it might occur,” Dr. Schuchat added.

WASHINGTON — The mumps outbreak that occurred in Iowa earlier this year is not necessarily the end of the illness in the United States, Dr. Anne Schuchat said at a press briefing sponsored by the National Foundation for Infectious Diseases.

The Iowa outbreak was the biggest in 20 years, “but that doesn't mean it's the last time we'll be seeing mumps,” said Dr. Schuchat, who is director of the National Immunization Program at the Centers for Disease Control and Prevention, Atlanta.

The mumps vaccine was first licensed in 1967 and has been very successful for the most part, said Dr. Schuchat. But that changed in March 2006, when the outbreak began; Iowa had more than 200 cases, “which was almost as many cases as would [normally] have been recorded throughout the entire United States.”

By June 20th, Iowa had 1,921 reported cases; by early July, a total of 4,600 cases had been reported nationwide, she added. Much of the outbreak occurred in eight states: Iowa, Kansas, Nebraska, South Dakota, Wisconsin, Illinois, Missouri, and Pennsylvania.

The clinical illness involved in the outbreak was primarily mild: 80% of the cases featured parotitis, and there were a few cases of meningitis, 59 cases of orchitis, and more than 40 hospitalizations. No deaths were confirmed with the outbreak.

Although there are no simple answers to what caused the outbreak, investigators think it may have begun with an unrecognized importation, possibly from the United Kingdom, which had a large mumps outbreak in 2004–2005 involving about 70,000 cases. “The strain that is circulating in our mumps outbreak is identical to the strain from [the United Kingdom], but that strain is also common in a number of other places where mumps vaccination is not as strong as we have here in the United States,” Dr. Schuchat said.

The Iowa outbreak started with a group of college students, and may have been helped to spread by the college student lifestyle, said Dr. Schuchat. “I don't like to think about what happens in colleges, but we know the way people live in college and the way they socialize can lead to high transmission of infections.”

In addition, “we also know college students in America have a lower two-dose vaccine coverage than do [students in] high schools or elementary schools,” she said. “That's just a fact of life because we changed our recommendations for the two-dose schedule in 1989, and had pretty good follow-up in terms of school entry, but college students were older and didn't necessarily get that second dose before they went off to college.”

Delayed recognition of the outbreak also may have given it a chance to take off and spread to a lot of colleges and states, Dr. Schuchat continued. “Why did we have delayed recognition? [This occurred] partly because physicians and parents and kids aren't that familiar with mumps any more, and partly because some of the presentations were atypical. They weren't that jaw swelling that people know; there were other respiratory presentations.”

Another possible factor in the spread of the outbreak is the overall effectiveness of the vaccine itself. “The vaccine is good, but not great,” she said. “When you get two doses of mumps vaccine, we think 90% of people are protected, but it's not 100%. So 10% of people, even those who have good immune systems and get the most vaccine, will still be vulnerable to mumps if they get exposed to the virus.”

Dr. Schuchat stressed that the outbreak could have been much worse. “We have a very high measles/mumps/rubella vaccine coverage level, and the vaccine effectiveness of the two-dose schedule probably prevented thousands and thousands of cases.”

Investigators also think the disease was milder than it might otherwise have been, “because it was occurring in people who had one or two doses and may have not gotten the more severe forms of mumps even though they were adults and in an age group where it might occur,” Dr. Schuchat added.

WASHINGTON — The mumps outbreak that occurred in Iowa earlier this year is not necessarily the end of the illness in the United States, Dr. Anne Schuchat said at a press briefing sponsored by the National Foundation for Infectious Diseases.

The Iowa outbreak was the biggest in 20 years, “but that doesn't mean it's the last time we'll be seeing mumps,” said Dr. Schuchat, who is director of the National Immunization Program at the Centers for Disease Control and Prevention, Atlanta.

The mumps vaccine was first licensed in 1967 and has been very successful for the most part, said Dr. Schuchat. But that changed in March 2006, when the outbreak began; Iowa had more than 200 cases, “which was almost as many cases as would [normally] have been recorded throughout the entire United States.”

By June 20th, Iowa had 1,921 reported cases; by early July, a total of 4,600 cases had been reported nationwide, she added. Much of the outbreak occurred in eight states: Iowa, Kansas, Nebraska, South Dakota, Wisconsin, Illinois, Missouri, and Pennsylvania.

The clinical illness involved in the outbreak was primarily mild: 80% of the cases featured parotitis, and there were a few cases of meningitis, 59 cases of orchitis, and more than 40 hospitalizations. No deaths were confirmed with the outbreak.

Although there are no simple answers to what caused the outbreak, investigators think it may have begun with an unrecognized importation, possibly from the United Kingdom, which had a large mumps outbreak in 2004–2005 involving about 70,000 cases. “The strain that is circulating in our mumps outbreak is identical to the strain from [the United Kingdom], but that strain is also common in a number of other places where mumps vaccination is not as strong as we have here in the United States,” Dr. Schuchat said.

The Iowa outbreak started with a group of college students, and may have been helped to spread by the college student lifestyle, said Dr. Schuchat. “I don't like to think about what happens in colleges, but we know the way people live in college and the way they socialize can lead to high transmission of infections.”

In addition, “we also know college students in America have a lower two-dose vaccine coverage than do [students in] high schools or elementary schools,” she said. “That's just a fact of life because we changed our recommendations for the two-dose schedule in 1989, and had pretty good follow-up in terms of school entry, but college students were older and didn't necessarily get that second dose before they went off to college.”

Delayed recognition of the outbreak also may have given it a chance to take off and spread to a lot of colleges and states, Dr. Schuchat continued. “Why did we have delayed recognition? [This occurred] partly because physicians and parents and kids aren't that familiar with mumps any more, and partly because some of the presentations were atypical. They weren't that jaw swelling that people know; there were other respiratory presentations.”

Another possible factor in the spread of the outbreak is the overall effectiveness of the vaccine itself. “The vaccine is good, but not great,” she said. “When you get two doses of mumps vaccine, we think 90% of people are protected, but it's not 100%. So 10% of people, even those who have good immune systems and get the most vaccine, will still be vulnerable to mumps if they get exposed to the virus.”

Dr. Schuchat stressed that the outbreak could have been much worse. “We have a very high measles/mumps/rubella vaccine coverage level, and the vaccine effectiveness of the two-dose schedule probably prevented thousands and thousands of cases.”

Investigators also think the disease was milder than it might otherwise have been, “because it was occurring in people who had one or two doses and may have not gotten the more severe forms of mumps even though they were adults and in an age group where it might occur,” Dr. Schuchat added.

WASHINGTON — Specialists who treat adults should be encouraged to give preventive vaccines to their patients, Dr. William Schaffner said at a press briefing sponsored by the National Foundation for Infectious Diseases.

“A lot of adults don't see their internists or family physicians. They are taken care of by specialists,” Dr. Schaffner said in a discussion with journalists after the briefing.

One problem with getting adults immunized is that many of them don't go to doctors in the first place, said Dr. Schaffner, chairman of preventive medicine at Vanderbilt University in Nashville, Tenn.

“Women, at least, go to ob.gyns., and ob.gyns.—under the leadership of the American College of Obstetricians and Gynecologists—are increasingly acknowledging that they're primary care physicians. They're beginning to get the word that part of what they have to do as primary care physicians is immunize.”

Ob.gyns. have already taken responsibility for cervical cancer screening, noted Dr. Schaffner, who is also professor of infectious diseases at Vanderbilt. “I predict they'll be avid promoters of the human papillomavirus vaccine. If we can get them to expand their purview, they can think about hepatitis B: 'That's a sexually transmitted disease—I know how that works.'” Ob.gyns. can also be approached regarding influenza vaccinations for pregnant women, he added. “We've got to bring them along. These are wonderful opportunities, and I think we're going to see a major change in ob.gyns. doing this.”

Internal medicine subspecialists are another likely target, according to Dr. Schaffner. “If you have rheumatoid arthritis or lupus, the only doctor you may be going to is a rheumatologist. Nephrologists take care of patients with kidney failure, and gastroenterologists take care of a lot of patients with inflammatory bowel disease who don't very regularly go to a general internist.” These subspecialists could start with pneumococcal and influenza vaccines, which all their patients are eligible for, he said.

There is one group of internal medicine subspecialists that may be a tougher sell, however: cardiologists. “They haven't been reached [with the message] that in their outpatient practice, they ought to be ordering and delivering vaccines, because in large measure many of their patients don't have internists who take care of them,” Dr. Schaffner said. But even with so many specialists who could be vaccinating patients, none of them will be very interested in doing so until the reimbursement situation has improved, he said.

WASHINGTON — Specialists who treat adults should be encouraged to give preventive vaccines to their patients, Dr. William Schaffner said at a press briefing sponsored by the National Foundation for Infectious Diseases.

“A lot of adults don't see their internists or family physicians. They are taken care of by specialists,” Dr. Schaffner said in a discussion with journalists after the briefing.

One problem with getting adults immunized is that many of them don't go to doctors in the first place, said Dr. Schaffner, chairman of preventive medicine at Vanderbilt University in Nashville, Tenn.

“Women, at least, go to ob.gyns., and ob.gyns.—under the leadership of the American College of Obstetricians and Gynecologists—are increasingly acknowledging that they're primary care physicians. They're beginning to get the word that part of what they have to do as primary care physicians is immunize.”

Ob.gyns. have already taken responsibility for cervical cancer screening, noted Dr. Schaffner, who is also professor of infectious diseases at Vanderbilt. “I predict they'll be avid promoters of the human papillomavirus vaccine. If we can get them to expand their purview, they can think about hepatitis B: 'That's a sexually transmitted disease—I know how that works.'” Ob.gyns. can also be approached regarding influenza vaccinations for pregnant women, he added. “We've got to bring them along. These are wonderful opportunities, and I think we're going to see a major change in ob.gyns. doing this.”

Internal medicine subspecialists are another likely target, according to Dr. Schaffner. “If you have rheumatoid arthritis or lupus, the only doctor you may be going to is a rheumatologist. Nephrologists take care of patients with kidney failure, and gastroenterologists take care of a lot of patients with inflammatory bowel disease who don't very regularly go to a general internist.” These subspecialists could start with pneumococcal and influenza vaccines, which all their patients are eligible for, he said.

There is one group of internal medicine subspecialists that may be a tougher sell, however: cardiologists. “They haven't been reached [with the message] that in their outpatient practice, they ought to be ordering and delivering vaccines, because in large measure many of their patients don't have internists who take care of them,” Dr. Schaffner said. But even with so many specialists who could be vaccinating patients, none of them will be very interested in doing so until the reimbursement situation has improved, he said.

WASHINGTON — Specialists who treat adults should be encouraged to give preventive vaccines to their patients, Dr. William Schaffner said at a press briefing sponsored by the National Foundation for Infectious Diseases.

“A lot of adults don't see their internists or family physicians. They are taken care of by specialists,” Dr. Schaffner said in a discussion with journalists after the briefing.

One problem with getting adults immunized is that many of them don't go to doctors in the first place, said Dr. Schaffner, chairman of preventive medicine at Vanderbilt University in Nashville, Tenn.

“Women, at least, go to ob.gyns., and ob.gyns.—under the leadership of the American College of Obstetricians and Gynecologists—are increasingly acknowledging that they're primary care physicians. They're beginning to get the word that part of what they have to do as primary care physicians is immunize.”

Ob.gyns. have already taken responsibility for cervical cancer screening, noted Dr. Schaffner, who is also professor of infectious diseases at Vanderbilt. “I predict they'll be avid promoters of the human papillomavirus vaccine. If we can get them to expand their purview, they can think about hepatitis B: 'That's a sexually transmitted disease—I know how that works.'” Ob.gyns. can also be approached regarding influenza vaccinations for pregnant women, he added. “We've got to bring them along. These are wonderful opportunities, and I think we're going to see a major change in ob.gyns. doing this.”

Internal medicine subspecialists are another likely target, according to Dr. Schaffner. “If you have rheumatoid arthritis or lupus, the only doctor you may be going to is a rheumatologist. Nephrologists take care of patients with kidney failure, and gastroenterologists take care of a lot of patients with inflammatory bowel disease who don't very regularly go to a general internist.” These subspecialists could start with pneumococcal and influenza vaccines, which all their patients are eligible for, he said.

There is one group of internal medicine subspecialists that may be a tougher sell, however: cardiologists. “They haven't been reached [with the message] that in their outpatient practice, they ought to be ordering and delivering vaccines, because in large measure many of their patients don't have internists who take care of them,” Dr. Schaffner said. But even with so many specialists who could be vaccinating patients, none of them will be very interested in doing so until the reimbursement situation has improved, he said.

WASHINGTON — Specialists who treat adults should be encouraged to give preventive vaccines to their patients, Dr. William Schaffner said at a press briefing sponsored by the National Foundation for Infectious Diseases.

"A lot of adults don't see their internists or family physicians. They are taken care of by specialists," Dr. Schaffner said in a discussion with journalists after the briefing.

One problem with getting adults immunized is that many of them don't go to doctors in the first place, said Dr. Schaffner, chairman of preventive medicine at Vanderbilt University in Nashville, Tenn.

"Women, at least, go to ob.gyns., and ob.gyns.—under the leadership of the American College of Obstetricians and Gynecologists—are increasingly acknowledging that they're primary care physicians. They're beginning to get the word that part of what they have to do as primary care physicians is immunize."

Ob.gyns. have already taken responsibility for cervical cancer screening, noted Dr. Schaffner, who is also professor of infectious diseases at Vanderbilt. "I predict they'll be avid promoters of the human papillomavirus vaccine. If we can get them to expand their purview, they can think about hepatitis B: 'That's a sexually transmitted disease-I know how that works.'"

Ob.gyns. can also be approached regarding influenza vaccinations for pregnant women, he added. "We've got to bring them along. These are wonderful opportunities, and I think we're going to see a major change in ob.gyns. doing this."

Internal medicine subspecialists are another likely target, according to Dr. Schaffner. "If you have rheumatoid arthritis or lupus, the only doctor you may be going to is a rheumatologist. Nephrologists take care of patients with kidney failure, and gastroenterologists take care of a lot of patients with inflammatory bowel disease who don't very regularly go to a general internist."

These subspecialists could start with pneumococcal and influenza vaccines, "which categorically all their patients are eligible for," he said.

There is one group of internal medicine subspecialists that may be a tougher sell, however: cardiologists. "They haven't been reached [with the message] that in their outpatient practice, they ought to be ordering and delivering vaccines, because in large measure, many of their patients don't have internists who take care of them," Dr. Schaffner said.

But even with so many specialists who could be vaccinating patients, none of them will be very interested in doing so until the reimbursement situation has improved, he said. "No provider is going to get rich giving vaccines, but they don't want to lose money. You have to structure it so that [physicians] and the people who run their offices know that there's at least a modest potential" for profit, he added.

WASHINGTON — Specialists who treat adults should be encouraged to give preventive vaccines to their patients, Dr. William Schaffner said at a press briefing sponsored by the National Foundation for Infectious Diseases.

"A lot of adults don't see their internists or family physicians. They are taken care of by specialists," Dr. Schaffner said in a discussion with journalists after the briefing.

One problem with getting adults immunized is that many of them don't go to doctors in the first place, said Dr. Schaffner, chairman of preventive medicine at Vanderbilt University in Nashville, Tenn.

"Women, at least, go to ob.gyns., and ob.gyns.—under the leadership of the American College of Obstetricians and Gynecologists—are increasingly acknowledging that they're primary care physicians. They're beginning to get the word that part of what they have to do as primary care physicians is immunize."

Ob.gyns. have already taken responsibility for cervical cancer screening, noted Dr. Schaffner, who is also professor of infectious diseases at Vanderbilt. "I predict they'll be avid promoters of the human papillomavirus vaccine. If we can get them to expand their purview, they can think about hepatitis B: 'That's a sexually transmitted disease-I know how that works.'"

Ob.gyns. can also be approached regarding influenza vaccinations for pregnant women, he added. "We've got to bring them along. These are wonderful opportunities, and I think we're going to see a major change in ob.gyns. doing this."

Internal medicine subspecialists are another likely target, according to Dr. Schaffner. "If you have rheumatoid arthritis or lupus, the only doctor you may be going to is a rheumatologist. Nephrologists take care of patients with kidney failure, and gastroenterologists take care of a lot of patients with inflammatory bowel disease who don't very regularly go to a general internist."

These subspecialists could start with pneumococcal and influenza vaccines, "which categorically all their patients are eligible for," he said.

There is one group of internal medicine subspecialists that may be a tougher sell, however: cardiologists. "They haven't been reached [with the message] that in their outpatient practice, they ought to be ordering and delivering vaccines, because in large measure, many of their patients don't have internists who take care of them," Dr. Schaffner said.

But even with so many specialists who could be vaccinating patients, none of them will be very interested in doing so until the reimbursement situation has improved, he said. "No provider is going to get rich giving vaccines, but they don't want to lose money. You have to structure it so that [physicians] and the people who run their offices know that there's at least a modest potential" for profit, he added.

WASHINGTON — Specialists who treat adults should be encouraged to give preventive vaccines to their patients, Dr. William Schaffner said at a press briefing sponsored by the National Foundation for Infectious Diseases.

"A lot of adults don't see their internists or family physicians. They are taken care of by specialists," Dr. Schaffner said in a discussion with journalists after the briefing.

One problem with getting adults immunized is that many of them don't go to doctors in the first place, said Dr. Schaffner, chairman of preventive medicine at Vanderbilt University in Nashville, Tenn.

"Women, at least, go to ob.gyns., and ob.gyns.—under the leadership of the American College of Obstetricians and Gynecologists—are increasingly acknowledging that they're primary care physicians. They're beginning to get the word that part of what they have to do as primary care physicians is immunize."

Ob.gyns. have already taken responsibility for cervical cancer screening, noted Dr. Schaffner, who is also professor of infectious diseases at Vanderbilt. "I predict they'll be avid promoters of the human papillomavirus vaccine. If we can get them to expand their purview, they can think about hepatitis B: 'That's a sexually transmitted disease-I know how that works.'"

Ob.gyns. can also be approached regarding influenza vaccinations for pregnant women, he added. "We've got to bring them along. These are wonderful opportunities, and I think we're going to see a major change in ob.gyns. doing this."

Internal medicine subspecialists are another likely target, according to Dr. Schaffner. "If you have rheumatoid arthritis or lupus, the only doctor you may be going to is a rheumatologist. Nephrologists take care of patients with kidney failure, and gastroenterologists take care of a lot of patients with inflammatory bowel disease who don't very regularly go to a general internist."

These subspecialists could start with pneumococcal and influenza vaccines, "which categorically all their patients are eligible for," he said.

There is one group of internal medicine subspecialists that may be a tougher sell, however: cardiologists. "They haven't been reached [with the message] that in their outpatient practice, they ought to be ordering and delivering vaccines, because in large measure, many of their patients don't have internists who take care of them," Dr. Schaffner said.

But even with so many specialists who could be vaccinating patients, none of them will be very interested in doing so until the reimbursement situation has improved, he said. "No provider is going to get rich giving vaccines, but they don't want to lose money. You have to structure it so that [physicians] and the people who run their offices know that there's at least a modest potential" for profit, he added.

PHILADELPHIA — Physicians can help Medicare beneficiaries who are trying to select a Medicare drug coverage plan, but they have to make sure they follow all the rules, Charlene L. McGinty said at the annual meeting of the American Health Lawyers Association.

The drug benefit, also known as Part D, was passed by Congress in 2003 and became effective in January 2006. Patients pay an annual deductible of $250 as well as a premium of about $35 per month, depending on the plan they choose. The plan then pays 75% of drug costs until the patient has spent $2,250. After that, in most plans, the patient has to pay the next $3,850 out of pocket; this period is known as the “doughnut hole” or “coverage gap.” Once the beneficiaries' bills hit $5,100, the plan pays 95% of any remaining drug costs for the rest of the year. Low-income beneficiaries receive a more generous benefit.

Drug plans are administered by private insurers, but of all the plans participating, 20 plans represent 90% of the market, said Ms. McGinty, a partner in an Atlanta law firm. “The biggest group is [affiliated] with UnitedHealth Group,” she added. There are 10 “national plans” approved by the Centers for Medicare and Medicaid Services; those plans are recommended for snowbirds who live in one place during the spring, summer, and fall but go south or west for the winter.

To help beneficiaries navigate the maze of plans, physicians are allowed to do certain things, Ms. McGinty said. She recommended asking patients the following questions about the plans they're considering signing up with:

▸ How much is the deductible—the standard $250, or less?

▸ What about copays? Does the plan require a set copay or does it charge “coinsurance,” which means the patient must pay a certain percentage of the drug cost, whatever it is?

▸ Which pharmacies are included in the plan's pharmacy network? “Many seniors have established relationships with pharmacies and pharmacists,” said Ms. McGinty. “They may not want to change them.”

▸ What is in the formulary? Are the patients' drugs covered, or will they have to go through prior authorization or step therapy before they can get their particular medications?

One audience member pointed out that although plans are supposed to review their formularies once every 180 days, their pickup of drugs approved in 2005 was “unbelievably poor.” If the plans base their formulary decisions on the model formulary published by the United States Pharmacopeia, that formulary is updated only once a year, he noted.

Ms. McGinty agreed that “there is a potential lag” to the new drugs coming on the model formulary, but added that each plan's pharmacy and therapeutics committee also is supposed to be keeping tracking of new drug approvals and deciding whether to add a new drug.

Off-Label Drug Use

Plans are supposed to approve off-label use as long as the use is listed in one of three drug compendia, said Greg Jones, who is with the program integrity group at the Centers for Medicare and Medicaid Services. But trying to help a patient get a drug for an off-label use not listed in a compendium will be a “trouble spot” for doctors, he conceded.

Although providers can give patients some help in choosing a drug plan—and even help low-income beneficiaries fill out the paperwork to get better benefits—“tension exists because there are limitations on what providers can say” about various drug plans, Ms. McGinty explained. For example, providers cannot make specific plan recommendations, they can't steer an undecided enrollee to one plan over another, and they can't accept plan applications.

PHILADELPHIA — Physicians can help Medicare beneficiaries who are trying to select a Medicare drug coverage plan, but they have to make sure they follow all the rules, Charlene L. McGinty said at the annual meeting of the American Health Lawyers Association.

The drug benefit, also known as Part D, was passed by Congress in 2003 and became effective in January 2006. Patients pay an annual deductible of $250 as well as a premium of about $35 per month, depending on the plan they choose. The plan then pays 75% of drug costs until the patient has spent $2,250. After that, in most plans, the patient has to pay the next $3,850 out of pocket; this period is known as the “doughnut hole” or “coverage gap.” Once the beneficiaries' bills hit $5,100, the plan pays 95% of any remaining drug costs for the rest of the year. Low-income beneficiaries receive a more generous benefit.

Drug plans are administered by private insurers, but of all the plans participating, 20 plans represent 90% of the market, said Ms. McGinty, a partner in an Atlanta law firm. “The biggest group is [affiliated] with UnitedHealth Group,” she added. There are 10 “national plans” approved by the Centers for Medicare and Medicaid Services; those plans are recommended for snowbirds who live in one place during the spring, summer, and fall but go south or west for the winter.

To help beneficiaries navigate the maze of plans, physicians are allowed to do certain things, Ms. McGinty said. She recommended asking patients the following questions about the plans they're considering signing up with:

▸ How much is the deductible—the standard $250, or less?

▸ What about copays? Does the plan require a set copay or does it charge “coinsurance,” which means the patient must pay a certain percentage of the drug cost, whatever it is?

▸ Which pharmacies are included in the plan's pharmacy network? “Many seniors have established relationships with pharmacies and pharmacists,” said Ms. McGinty. “They may not want to change them.”

▸ What is in the formulary? Are the patients' drugs covered, or will they have to go through prior authorization or step therapy before they can get their particular medications?

One audience member pointed out that although plans are supposed to review their formularies once every 180 days, their pickup of drugs approved in 2005 was “unbelievably poor.” If the plans base their formulary decisions on the model formulary published by the United States Pharmacopeia, that formulary is updated only once a year, he noted.

Ms. McGinty agreed that “there is a potential lag” to the new drugs coming on the model formulary, but added that each plan's pharmacy and therapeutics committee also is supposed to be keeping tracking of new drug approvals and deciding whether to add a new drug.

Off-Label Drug Use

Plans are supposed to approve off-label use as long as the use is listed in one of three drug compendia, said Greg Jones, who is with the program integrity group at the Centers for Medicare and Medicaid Services. But trying to help a patient get a drug for an off-label use not listed in a compendium will be a “trouble spot” for doctors, he conceded.

Although providers can give patients some help in choosing a drug plan—and even help low-income beneficiaries fill out the paperwork to get better benefits—“tension exists because there are limitations on what providers can say” about various drug plans, Ms. McGinty explained. For example, providers cannot make specific plan recommendations, they can't steer an undecided enrollee to one plan over another, and they can't accept plan applications.

PHILADELPHIA — Physicians can help Medicare beneficiaries who are trying to select a Medicare drug coverage plan, but they have to make sure they follow all the rules, Charlene L. McGinty said at the annual meeting of the American Health Lawyers Association.

The drug benefit, also known as Part D, was passed by Congress in 2003 and became effective in January 2006. Patients pay an annual deductible of $250 as well as a premium of about $35 per month, depending on the plan they choose. The plan then pays 75% of drug costs until the patient has spent $2,250. After that, in most plans, the patient has to pay the next $3,850 out of pocket; this period is known as the “doughnut hole” or “coverage gap.” Once the beneficiaries' bills hit $5,100, the plan pays 95% of any remaining drug costs for the rest of the year. Low-income beneficiaries receive a more generous benefit.

Drug plans are administered by private insurers, but of all the plans participating, 20 plans represent 90% of the market, said Ms. McGinty, a partner in an Atlanta law firm. “The biggest group is [affiliated] with UnitedHealth Group,” she added. There are 10 “national plans” approved by the Centers for Medicare and Medicaid Services; those plans are recommended for snowbirds who live in one place during the spring, summer, and fall but go south or west for the winter.

To help beneficiaries navigate the maze of plans, physicians are allowed to do certain things, Ms. McGinty said. She recommended asking patients the following questions about the plans they're considering signing up with:

▸ How much is the deductible—the standard $250, or less?

▸ What about copays? Does the plan require a set copay or does it charge “coinsurance,” which means the patient must pay a certain percentage of the drug cost, whatever it is?

▸ Which pharmacies are included in the plan's pharmacy network? “Many seniors have established relationships with pharmacies and pharmacists,” said Ms. McGinty. “They may not want to change them.”

▸ What is in the formulary? Are the patients' drugs covered, or will they have to go through prior authorization or step therapy before they can get their particular medications?

One audience member pointed out that although plans are supposed to review their formularies once every 180 days, their pickup of drugs approved in 2005 was “unbelievably poor.” If the plans base their formulary decisions on the model formulary published by the United States Pharmacopeia, that formulary is updated only once a year, he noted.

Ms. McGinty agreed that “there is a potential lag” to the new drugs coming on the model formulary, but added that each plan's pharmacy and therapeutics committee also is supposed to be keeping tracking of new drug approvals and deciding whether to add a new drug.

Off-Label Drug Use

Plans are supposed to approve off-label use as long as the use is listed in one of three drug compendia, said Greg Jones, who is with the program integrity group at the Centers for Medicare and Medicaid Services. But trying to help a patient get a drug for an off-label use not listed in a compendium will be a “trouble spot” for doctors, he conceded.

Although providers can give patients some help in choosing a drug plan—and even help low-income beneficiaries fill out the paperwork to get better benefits—“tension exists because there are limitations on what providers can say” about various drug plans, Ms. McGinty explained. For example, providers cannot make specific plan recommendations, they can't steer an undecided enrollee to one plan over another, and they can't accept plan applications.