Joyce Frieden

BALTIMORE — Provisions in the Deficit Reduction Act are likely to profoundly affect health care for Medicaid patients, Cindy Mann said at the annual meeting of the American Society for Law, Medicine, and Ethics.

The Deficit Reduction Act (DRA) of 2005, signed into law last February by President Bush, includes “the most significant statutory changes in the Medicaid program arguably since the late 1980s,” said Ms. Mann, who is research professor at Georgetown University Health Policy Institute in Washington.

“It really is also the first time that Congress has legislated some specific cutbacks aimed at beneficiaries,” she added.

Many changes deal with Medicaid coverage requirements for states.

The law “gives [states] very broad flexibility to move away from what has been a system of mandatory and optional benefits to a system of benchmark benefits,” said Ms. Mann, who is also executive director of the Center for Children and Families at Georgetown. “One benchmark [states can use] is any state employee plan—not the one most used in your state, or the one that has the highest enrollment of dependents, it's any state employee plan that's offered.”

States could even construct a special plan just to be a benchmark and then offer it to state employees, “and that becomes [the] standard,” she said, at the meeting cosponsored by the University of Maryland.

The other way states can formulate an acceptable plan is by getting the approval of the federal Health and Human Services secretary.

The two state plan amendments now approved under the DRA—West Virginia and Kentucky—used the secretary-approved coverage option, Ms. Mann noted.

The DRA also allows states to change benefit packages for some groups and not for others, Ms. Mann said. “[States] could have one benchmark package in a rural area of the state and a different one for urban areas.

“It opens it up to any slice and dice a state decides it wants to do in terms of how it constructs these benchmark packages and to whom they will apply.”

A controversial change imposed by the DRA is a requirement that anyone applying for Medicaid who says they are a citizen must provide new documentation of their citizenship.

“Since 1996 there's been a provision requiring documentation of immigration status, and now there are very strict rules about documentation,” Ms. Mann said, adding that federal guidance on how to implement this section of the law is expected shortly.

The law also allows for several demonstration projects. For example, 10 states may start Health Opportunity Accounts, which are “a little like health savings accounts for the Medicaid program,” she said.

Another measure, championed by Sen. Charles Grassley (R-Iowa), is the Family Opportunity Act, which allows families to buy into Medicaid if they have severely disabled children, even if their family income is above the normal cutoff in their state for Medicaid eligibility.

Ms. Mann added that although the law contains profound changes, “it is often overstated what the changes were.

“In large part, what the DRA didn't do, Congress decided not to do. There was a debate about the areas of benefit guarantees for kids and there was a debate about the cost sharing. So while Congress did go a certain distance, it didn't go further than that certain distance, and I think that's an important consideration.”

BALTIMORE — Provisions in the Deficit Reduction Act are likely to profoundly affect health care for Medicaid patients, Cindy Mann said at the annual meeting of the American Society for Law, Medicine, and Ethics.

The Deficit Reduction Act (DRA) of 2005, signed into law last February by President Bush, includes “the most significant statutory changes in the Medicaid program arguably since the late 1980s,” said Ms. Mann, who is research professor at Georgetown University Health Policy Institute in Washington.

“It really is also the first time that Congress has legislated some specific cutbacks aimed at beneficiaries,” she added.

Many changes deal with Medicaid coverage requirements for states.

The law “gives [states] very broad flexibility to move away from what has been a system of mandatory and optional benefits to a system of benchmark benefits,” said Ms. Mann, who is also executive director of the Center for Children and Families at Georgetown. “One benchmark [states can use] is any state employee plan—not the one most used in your state, or the one that has the highest enrollment of dependents, it's any state employee plan that's offered.”

States could even construct a special plan just to be a benchmark and then offer it to state employees, “and that becomes [the] standard,” she said, at the meeting cosponsored by the University of Maryland.

The other way states can formulate an acceptable plan is by getting the approval of the federal Health and Human Services secretary.

The two state plan amendments now approved under the DRA—West Virginia and Kentucky—used the secretary-approved coverage option, Ms. Mann noted.

The DRA also allows states to change benefit packages for some groups and not for others, Ms. Mann said. “[States] could have one benchmark package in a rural area of the state and a different one for urban areas.

“It opens it up to any slice and dice a state decides it wants to do in terms of how it constructs these benchmark packages and to whom they will apply.”

A controversial change imposed by the DRA is a requirement that anyone applying for Medicaid who says they are a citizen must provide new documentation of their citizenship.

“Since 1996 there's been a provision requiring documentation of immigration status, and now there are very strict rules about documentation,” Ms. Mann said, adding that federal guidance on how to implement this section of the law is expected shortly.

The law also allows for several demonstration projects. For example, 10 states may start Health Opportunity Accounts, which are “a little like health savings accounts for the Medicaid program,” she said.

Another measure, championed by Sen. Charles Grassley (R-Iowa), is the Family Opportunity Act, which allows families to buy into Medicaid if they have severely disabled children, even if their family income is above the normal cutoff in their state for Medicaid eligibility.

Ms. Mann added that although the law contains profound changes, “it is often overstated what the changes were.

“In large part, what the DRA didn't do, Congress decided not to do. There was a debate about the areas of benefit guarantees for kids and there was a debate about the cost sharing. So while Congress did go a certain distance, it didn't go further than that certain distance, and I think that's an important consideration.”

BALTIMORE — Provisions in the Deficit Reduction Act are likely to profoundly affect health care for Medicaid patients, Cindy Mann said at the annual meeting of the American Society for Law, Medicine, and Ethics.

The Deficit Reduction Act (DRA) of 2005, signed into law last February by President Bush, includes “the most significant statutory changes in the Medicaid program arguably since the late 1980s,” said Ms. Mann, who is research professor at Georgetown University Health Policy Institute in Washington.

“It really is also the first time that Congress has legislated some specific cutbacks aimed at beneficiaries,” she added.

Many changes deal with Medicaid coverage requirements for states.

The law “gives [states] very broad flexibility to move away from what has been a system of mandatory and optional benefits to a system of benchmark benefits,” said Ms. Mann, who is also executive director of the Center for Children and Families at Georgetown. “One benchmark [states can use] is any state employee plan—not the one most used in your state, or the one that has the highest enrollment of dependents, it's any state employee plan that's offered.”

States could even construct a special plan just to be a benchmark and then offer it to state employees, “and that becomes [the] standard,” she said, at the meeting cosponsored by the University of Maryland.

The other way states can formulate an acceptable plan is by getting the approval of the federal Health and Human Services secretary.

The two state plan amendments now approved under the DRA—West Virginia and Kentucky—used the secretary-approved coverage option, Ms. Mann noted.

The DRA also allows states to change benefit packages for some groups and not for others, Ms. Mann said. “[States] could have one benchmark package in a rural area of the state and a different one for urban areas.

“It opens it up to any slice and dice a state decides it wants to do in terms of how it constructs these benchmark packages and to whom they will apply.”

A controversial change imposed by the DRA is a requirement that anyone applying for Medicaid who says they are a citizen must provide new documentation of their citizenship.

“Since 1996 there's been a provision requiring documentation of immigration status, and now there are very strict rules about documentation,” Ms. Mann said, adding that federal guidance on how to implement this section of the law is expected shortly.

The law also allows for several demonstration projects. For example, 10 states may start Health Opportunity Accounts, which are “a little like health savings accounts for the Medicaid program,” she said.

Another measure, championed by Sen. Charles Grassley (R-Iowa), is the Family Opportunity Act, which allows families to buy into Medicaid if they have severely disabled children, even if their family income is above the normal cutoff in their state for Medicaid eligibility.

Ms. Mann added that although the law contains profound changes, “it is often overstated what the changes were.

“In large part, what the DRA didn't do, Congress decided not to do. There was a debate about the areas of benefit guarantees for kids and there was a debate about the cost sharing. So while Congress did go a certain distance, it didn't go further than that certain distance, and I think that's an important consideration.”

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 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 (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 upon.

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 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 (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 upon.

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 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 (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 upon.

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.

“A large portion of these doctors have as their primary motive that they want to earn more money,” said Mr. Marquis, a partner in a Holland, Mich., law firm. However, while money plays a big role, other factors also influence the decision, said Mr. Marquis, who helps physicians set up concierge practices.

Another reason for the move to concierge care is lifestyle, he said. “If [I've] heard the analogy to the hamster wheel once, I've heard it a million times. 'I get up every day, I get on the hamster wheel, I run for 10 hours, I get off, and I hope to God I've seen enough patients to pay the light bill.' Concierge medicine does offer them some degree of better lifestyle as they perceive it.”

Another reason physicians give is to improve patient care. “You'd be surprised at the number of physicians who list [improving patient care] as their top priority,” he said. 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. I think that is bogus,” said Mr. Marquis, adding 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.' It sounds hokey, but I think they're being sincere when they tell me that,” 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, though 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. “They just want to game the system a little bit, and get a little more money out of it.”

Proponents also say that the type of intensive medical care provided is very good for sick people with chronic illnesses, and that the increased income ultimately will make medicine more attractive and lead more people toward a medical profession. Frank Pasquale of the Seton Hall University School of Law in Newark, N.J., agreed. Mr. Pasquale noted that concierge practices provide preventive care; “directly therapeutic” care, in which patients have the ability to jump the line and be seen the same day; and nonmedical amenities such as fluffy exam robes or a private waiting room.

“The current [critics] are attacking concierge care as a unitary phenomenon,” Mr. Pasquale said. “I say, don't attack preventive care, but the other two [directly therapeutic care and nonmedical amenities] are a problem.”

Concierge care has “amazing benefits” for the doctors and patients who participate, such as more income for the physicians and more attention for the patients, he continued. But there are also problems, such as a disruption of care relationships for patients who can't afford or don't want to join the concierge practice.

“There's the worry of the 'death spiral,' where all the better physicians will go into concierge practice and everyone who can't afford a concierge practice will be left with physicians who don't have quite as good a reputation,” Mr. Pasquale said.

Proponents of concierge care say that such a disaster scenario is not likely, because concierge medicine is not apt to spread. “It's just a new product,” Mr. Pasquale said.

Rather than regulating concierge care out of existence, Mr. Pasquale suggests that lawmakers tax directly therapeutic care and nonmedical amenities, and use the tax proceeds to help provide access to care for the poor.

Sandra J. Carnahan of the South Texas College of Law in Houston suggested that private insurers consider dropping concierge practices from their networks. In the case of physicians who treat Medicare patients, because taxpayer money is used to pay for the physicians' medical education, “that ought to [dictate] that they have a reasonable patient load … and physicians should not be able to use the system to choose the wealthiest, healthiest patients who can pay the fees.”

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.

“A large portion of these doctors have as their primary motive that they want to earn more money,” said Mr. Marquis, a partner in a Holland, Mich., law firm. However, while money plays a big role, other factors also influence the decision, said Mr. Marquis, who helps physicians set up concierge practices.

Another reason for the move to concierge care is lifestyle, he said. “If [I've] heard the analogy to the hamster wheel once, I've heard it a million times. 'I get up every day, I get on the hamster wheel, I run for 10 hours, I get off, and I hope to God I've seen enough patients to pay the light bill.' Concierge medicine does offer them some degree of better lifestyle as they perceive it.”

Another reason physicians give is to improve patient care. “You'd be surprised at the number of physicians who list [improving patient care] as their top priority,” he said. 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. I think that is bogus,” said Mr. Marquis, adding 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.' It sounds hokey, but I think they're being sincere when they tell me that,” 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, though 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. “They just want to game the system a little bit, and get a little more money out of it.”

Proponents also say that the type of intensive medical care provided is very good for sick people with chronic illnesses, and that the increased income ultimately will make medicine more attractive and lead more people toward a medical profession. Frank Pasquale of the Seton Hall University School of Law in Newark, N.J., agreed. Mr. Pasquale noted that concierge practices provide preventive care; “directly therapeutic” care, in which patients have the ability to jump the line and be seen the same day; and nonmedical amenities such as fluffy exam robes or a private waiting room.

“The current [critics] are attacking concierge care as a unitary phenomenon,” Mr. Pasquale said. “I say, don't attack preventive care, but the other two [directly therapeutic care and nonmedical amenities] are a problem.”

Concierge care has “amazing benefits” for the doctors and patients who participate, such as more income for the physicians and more attention for the patients, he continued. But there are also problems, such as a disruption of care relationships for patients who can't afford or don't want to join the concierge practice.

“There's the worry of the 'death spiral,' where all the better physicians will go into concierge practice and everyone who can't afford a concierge practice will be left with physicians who don't have quite as good a reputation,” Mr. Pasquale said.

Proponents of concierge care say that such a disaster scenario is not likely, because concierge medicine is not apt to spread. “It's just a new product,” Mr. Pasquale said.

Rather than regulating concierge care out of existence, Mr. Pasquale suggests that lawmakers tax directly therapeutic care and nonmedical amenities, and use the tax proceeds to help provide access to care for the poor.

Sandra J. Carnahan of the South Texas College of Law in Houston suggested that private insurers consider dropping concierge practices from their networks. In the case of physicians who treat Medicare patients, because taxpayer money is used to pay for the physicians' medical education, “that ought to [dictate] that they have a reasonable patient load … and physicians should not be able to use the system to choose the wealthiest, healthiest patients who can pay the fees.”

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.

“A large portion of these doctors have as their primary motive that they want to earn more money,” said Mr. Marquis, a partner in a Holland, Mich., law firm. However, while money plays a big role, other factors also influence the decision, said Mr. Marquis, who helps physicians set up concierge practices.

Another reason for the move to concierge care is lifestyle, he said. “If [I've] heard the analogy to the hamster wheel once, I've heard it a million times. 'I get up every day, I get on the hamster wheel, I run for 10 hours, I get off, and I hope to God I've seen enough patients to pay the light bill.' Concierge medicine does offer them some degree of better lifestyle as they perceive it.”

Another reason physicians give is to improve patient care. “You'd be surprised at the number of physicians who list [improving patient care] as their top priority,” he said. 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. I think that is bogus,” said Mr. Marquis, adding 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.' It sounds hokey, but I think they're being sincere when they tell me that,” 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, though 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. “They just want to game the system a little bit, and get a little more money out of it.”

Proponents also say that the type of intensive medical care provided is very good for sick people with chronic illnesses, and that the increased income ultimately will make medicine more attractive and lead more people toward a medical profession. Frank Pasquale of the Seton Hall University School of Law in Newark, N.J., agreed. Mr. Pasquale noted that concierge practices provide preventive care; “directly therapeutic” care, in which patients have the ability to jump the line and be seen the same day; and nonmedical amenities such as fluffy exam robes or a private waiting room.

“The current [critics] are attacking concierge care as a unitary phenomenon,” Mr. Pasquale said. “I say, don't attack preventive care, but the other two [directly therapeutic care and nonmedical amenities] are a problem.”

Concierge care has “amazing benefits” for the doctors and patients who participate, such as more income for the physicians and more attention for the patients, he continued. But there are also problems, such as a disruption of care relationships for patients who can't afford or don't want to join the concierge practice.

“There's the worry of the 'death spiral,' where all the better physicians will go into concierge practice and everyone who can't afford a concierge practice will be left with physicians who don't have quite as good a reputation,” Mr. Pasquale said.

Proponents of concierge care say that such a disaster scenario is not likely, because concierge medicine is not apt to spread. “It's just a new product,” Mr. Pasquale said.

Rather than regulating concierge care out of existence, Mr. Pasquale suggests that lawmakers tax directly therapeutic care and nonmedical amenities, and use the tax proceeds to help provide access to care for the poor.

Sandra J. Carnahan of the South Texas College of Law in Houston suggested that private insurers consider dropping concierge practices from their networks. In the case of physicians who treat Medicare patients, because taxpayer money is used to pay for the physicians' medical education, “that ought to [dictate] that they have a reasonable patient load … and physicians should not be able to use the system to choose the wealthiest, healthiest patients who can pay the fees.”

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,” she said. “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,” she said. “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,” she said. “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.

New Certification for Diabetes Care

The American Diabetes Association and the Joint Commission on Certification of Healthcare Organizations are developing what they say is the first nationwide certification for inpatient diabetes care. To attain the certification, organizations will need to participate in an on-site review to assess compliance with national standards and adherence to guidelines for diabetes management. The review also will look at the organization's performance measurement and improvement programs, quality of physicians and other clinicians, patient self-management programs, leadership support, and the information technology that are being used to monitor patient care. “The collaboration between the ADA and the Joint Commission will help standardize the care provided for all diabetic patients in all inpatient departments in a hospital,” Jean Range, executive director for disease-specific care certification at the commission, said in a statement. “Through systematic monitoring of all diabetic patients, outcomes can be improved. This will lead to a better quality of life for diabetic patients and position certified organizations for success in pay-for-performance programs.” The commission plans to convene an expert panel that will develop performance measures for inpatient diabetes care.

Iacocca Funds Diabetes Cure Search

The Iacocca Foundation, a project of former Chrysler CEO Lee Iacocca, is giving $12 million to research projects aimed at finding a cure for diabetes. Two projects to be funded by the grants are clinical trials by Dr. David Nathan and his colleagues at Massachusetts General Hospital, Boston, and by Dr. Jerry Nadler at the University of Virginia, Charlottesville; both trials attempt to stop the autoimmune reaction that takes place in type 1 diabetes. Another project included in the funding, this one at the Harvard School of Public Health in Boston, looks at the link between childhood obesity and the development of type 2 diabetes. “These projects hold tremendous promise in the quest to find a cure for this terrible disease,” Mr. Iacocca said in a statement. “Medical research is costly, and providing the funding necessary to keep these and other diabetes research projects moving forward is and always will be our mission.” The foundation was established in 1984 in honor of Mr. Iacocca's late wife, Mary, who died of complications of type 1 diabetes. It has given more than $23 million to diabetes research.

Regulating Nanotechnology

The Food and Drug Administration has launched an internal nanotechnology task force aimed at figuring out new regulatory approaches for pharmaceutical products and devices that use nanotechnology materials. Nanotechnology materials are about 1–100 nm and often have different chemical and physical properties than larger materials do, such as altered magnetic properties and increased chemical and biologic activity, according to the FDA.

The agency will kick off its efforts with a public meeting scheduled for October 10 and will report its initial findings to the acting FDA commissioner within 9 months.

Fix SGR, Delay Imaging Cuts

Several members of Congress attempted to head off the CMS's proposals just before the August congressional recess. A bill (H.R. 5866) by Rep. Michael Burgess (R-Tex.) would put an end to physician fee cuts under Medicare by halting application of the sustainable growth rate by Jan. 1, 2007. Each year, the SGR has contributed to a decrease in payments; in 2007, that cut will be 5.1% (see p. 6). Rep. Burgess is proposing to tie physician fees to one factor only: the Medicare Economic Index minus 1%. According to Rep. Burgess, this places “more value on actual cost inputs.” Mike Hogan, the Washington representative for the Society of Thoracic Surgeons, said he believes there is a congressional consensus for a permanent physician payment fix, but added, “at the end of the day with the elections looming, I think there's a lot of possibility for things to go wrong.” Rep. Burgess' bill also would delay by 1 year proposed imaging payment cuts, and require the Institute of Medicine to study whether imaging saves money.

The American Medical Association called the Medicare Physician Payment Reform Bill and Quality Improvement Act of 2006 an “important step toward replacing the flawed Medicare physician payment formula.” Rep. Burgess' bill is the third in the House to seek to delay or repeal the imaging fee cuts. Rep. Joseph Pitts (R-Pa.) has called for a 2-year delay in H.R. 5704. A similar bill was recently introduced in the Senate by Gordon Smith (R-Ore.) and Jay Rockefeller (D-W.Va.).

Unique IDs for Medical Devices?

The FDA is seeking comments on how to create unique identifiers for medical devices and whether such a system might reduce errors or help improve adverse event reporting and make withdrawals easier. The agency has held several meetings with interested parties, but still has not proposed any requirements—even though in a final rule in 2004 it said it will require all pharmaceuticals to include identifying bar codes. According to an FDA statement, any input the agency receives during the 90-day comment period, which ends in early November, will help “determine what next steps the agency should take” on devices. An identifier might include the manufacturer, make and model, size and length, software version, lot number, and expiration date.

New Certification for Diabetes Care

The American Diabetes Association and the Joint Commission on Certification of Healthcare Organizations are developing what they say is the first nationwide certification for inpatient diabetes care. To attain the certification, organizations will need to participate in an on-site review to assess compliance with national standards and adherence to guidelines for diabetes management. The review also will look at the organization's performance measurement and improvement programs, quality of physicians and other clinicians, patient self-management programs, leadership support, and the information technology that are being used to monitor patient care. “The collaboration between the ADA and the Joint Commission will help standardize the care provided for all diabetic patients in all inpatient departments in a hospital,” Jean Range, executive director for disease-specific care certification at the commission, said in a statement. “Through systematic monitoring of all diabetic patients, outcomes can be improved. This will lead to a better quality of life for diabetic patients and position certified organizations for success in pay-for-performance programs.” The commission plans to convene an expert panel that will develop performance measures for inpatient diabetes care.

Iacocca Funds Diabetes Cure Search

The Iacocca Foundation, a project of former Chrysler CEO Lee Iacocca, is giving $12 million to research projects aimed at finding a cure for diabetes. Two projects to be funded by the grants are clinical trials by Dr. David Nathan and his colleagues at Massachusetts General Hospital, Boston, and by Dr. Jerry Nadler at the University of Virginia, Charlottesville; both trials attempt to stop the autoimmune reaction that takes place in type 1 diabetes. Another project included in the funding, this one at the Harvard School of Public Health in Boston, looks at the link between childhood obesity and the development of type 2 diabetes. “These projects hold tremendous promise in the quest to find a cure for this terrible disease,” Mr. Iacocca said in a statement. “Medical research is costly, and providing the funding necessary to keep these and other diabetes research projects moving forward is and always will be our mission.” The foundation was established in 1984 in honor of Mr. Iacocca's late wife, Mary, who died of complications of type 1 diabetes. It has given more than $23 million to diabetes research.

Regulating Nanotechnology

The Food and Drug Administration has launched an internal nanotechnology task force aimed at figuring out new regulatory approaches for pharmaceutical products and devices that use nanotechnology materials. Nanotechnology materials are about 1–100 nm and often have different chemical and physical properties than larger materials do, such as altered magnetic properties and increased chemical and biologic activity, according to the FDA.

The agency will kick off its efforts with a public meeting scheduled for October 10 and will report its initial findings to the acting FDA commissioner within 9 months.

Fix SGR, Delay Imaging Cuts

Several members of Congress attempted to head off the CMS's proposals just before the August congressional recess. A bill (H.R. 5866) by Rep. Michael Burgess (R-Tex.) would put an end to physician fee cuts under Medicare by halting application of the sustainable growth rate by Jan. 1, 2007. Each year, the SGR has contributed to a decrease in payments; in 2007, that cut will be 5.1% (see p. 6). Rep. Burgess is proposing to tie physician fees to one factor only: the Medicare Economic Index minus 1%. According to Rep. Burgess, this places “more value on actual cost inputs.” Mike Hogan, the Washington representative for the Society of Thoracic Surgeons, said he believes there is a congressional consensus for a permanent physician payment fix, but added, “at the end of the day with the elections looming, I think there's a lot of possibility for things to go wrong.” Rep. Burgess' bill also would delay by 1 year proposed imaging payment cuts, and require the Institute of Medicine to study whether imaging saves money.

The American Medical Association called the Medicare Physician Payment Reform Bill and Quality Improvement Act of 2006 an “important step toward replacing the flawed Medicare physician payment formula.” Rep. Burgess' bill is the third in the House to seek to delay or repeal the imaging fee cuts. Rep. Joseph Pitts (R-Pa.) has called for a 2-year delay in H.R. 5704. A similar bill was recently introduced in the Senate by Gordon Smith (R-Ore.) and Jay Rockefeller (D-W.Va.).

Unique IDs for Medical Devices?

The FDA is seeking comments on how to create unique identifiers for medical devices and whether such a system might reduce errors or help improve adverse event reporting and make withdrawals easier. The agency has held several meetings with interested parties, but still has not proposed any requirements—even though in a final rule in 2004 it said it will require all pharmaceuticals to include identifying bar codes. According to an FDA statement, any input the agency receives during the 90-day comment period, which ends in early November, will help “determine what next steps the agency should take” on devices. An identifier might include the manufacturer, make and model, size and length, software version, lot number, and expiration date.

New Certification for Diabetes Care

The American Diabetes Association and the Joint Commission on Certification of Healthcare Organizations are developing what they say is the first nationwide certification for inpatient diabetes care. To attain the certification, organizations will need to participate in an on-site review to assess compliance with national standards and adherence to guidelines for diabetes management. The review also will look at the organization's performance measurement and improvement programs, quality of physicians and other clinicians, patient self-management programs, leadership support, and the information technology that are being used to monitor patient care. “The collaboration between the ADA and the Joint Commission will help standardize the care provided for all diabetic patients in all inpatient departments in a hospital,” Jean Range, executive director for disease-specific care certification at the commission, said in a statement. “Through systematic monitoring of all diabetic patients, outcomes can be improved. This will lead to a better quality of life for diabetic patients and position certified organizations for success in pay-for-performance programs.” The commission plans to convene an expert panel that will develop performance measures for inpatient diabetes care.

Iacocca Funds Diabetes Cure Search

The Iacocca Foundation, a project of former Chrysler CEO Lee Iacocca, is giving $12 million to research projects aimed at finding a cure for diabetes. Two projects to be funded by the grants are clinical trials by Dr. David Nathan and his colleagues at Massachusetts General Hospital, Boston, and by Dr. Jerry Nadler at the University of Virginia, Charlottesville; both trials attempt to stop the autoimmune reaction that takes place in type 1 diabetes. Another project included in the funding, this one at the Harvard School of Public Health in Boston, looks at the link between childhood obesity and the development of type 2 diabetes. “These projects hold tremendous promise in the quest to find a cure for this terrible disease,” Mr. Iacocca said in a statement. “Medical research is costly, and providing the funding necessary to keep these and other diabetes research projects moving forward is and always will be our mission.” The foundation was established in 1984 in honor of Mr. Iacocca's late wife, Mary, who died of complications of type 1 diabetes. It has given more than $23 million to diabetes research.

Regulating Nanotechnology

The Food and Drug Administration has launched an internal nanotechnology task force aimed at figuring out new regulatory approaches for pharmaceutical products and devices that use nanotechnology materials. Nanotechnology materials are about 1–100 nm and often have different chemical and physical properties than larger materials do, such as altered magnetic properties and increased chemical and biologic activity, according to the FDA.

The agency will kick off its efforts with a public meeting scheduled for October 10 and will report its initial findings to the acting FDA commissioner within 9 months.

Fix SGR, Delay Imaging Cuts

Several members of Congress attempted to head off the CMS's proposals just before the August congressional recess. A bill (H.R. 5866) by Rep. Michael Burgess (R-Tex.) would put an end to physician fee cuts under Medicare by halting application of the sustainable growth rate by Jan. 1, 2007. Each year, the SGR has contributed to a decrease in payments; in 2007, that cut will be 5.1% (see p. 6). Rep. Burgess is proposing to tie physician fees to one factor only: the Medicare Economic Index minus 1%. According to Rep. Burgess, this places “more value on actual cost inputs.” Mike Hogan, the Washington representative for the Society of Thoracic Surgeons, said he believes there is a congressional consensus for a permanent physician payment fix, but added, “at the end of the day with the elections looming, I think there's a lot of possibility for things to go wrong.” Rep. Burgess' bill also would delay by 1 year proposed imaging payment cuts, and require the Institute of Medicine to study whether imaging saves money.

The American Medical Association called the Medicare Physician Payment Reform Bill and Quality Improvement Act of 2006 an “important step toward replacing the flawed Medicare physician payment formula.” Rep. Burgess' bill is the third in the House to seek to delay or repeal the imaging fee cuts. Rep. Joseph Pitts (R-Pa.) has called for a 2-year delay in H.R. 5704. A similar bill was recently introduced in the Senate by Gordon Smith (R-Ore.) and Jay Rockefeller (D-W.Va.).

Unique IDs for Medical Devices?

The FDA is seeking comments on how to create unique identifiers for medical devices and whether such a system might reduce errors or help improve adverse event reporting and make withdrawals easier. The agency has held several meetings with interested parties, but still has not proposed any requirements—even though in a final rule in 2004 it said it will require all pharmaceuticals to include identifying bar codes. According to an FDA statement, any input the agency receives during the 90-day comment period, which ends in early November, will help “determine what next steps the agency should take” on devices. An identifier might include the manufacturer, make and model, size and length, software version, lot number, and expiration date.

WASHINGTON — Medicare has a number of demonstration projects underway to help chronically ill beneficiaries get better care, and is developing more, Linda Magno said at a meeting of the Practicing Physicians Advisory Council.

Beneficiaries with chronic illnesses are a significant part of the program's budget, said Ms. Magno, director of Medicare demonstrations for the Centers for Medicare and Medicaid Services (CMS). Although beneficiaries with five or more chronic conditions make up only 20% of all beneficiaries, they account for two-thirds of Medicare spending, she noted.

With all of the spending on this population, opportunities exist for making sure the money is spent more efficiently, Ms. Magno said. Currently, CMS has three demonstration projects going in chronic care:

▸ Medicare Coordinated Care Demonstration. In this project, which was mandated by the Balanced Budget Act of 1997, the agency is examining various care coordination models that “improve quality of services to chronically ill beneficiaries and reduce Medicare expenditures.” The Health and Human Services secretary has discretion to continue or expand projects, Ms. Magno said, adding that currently 11 sites—a mix of urban and rural hospitals and long-term care facilities—are involved in this demonstration. Interventions include patient and provider education, prescription drug management, case management, and disease management.

▸ Care Management for High-Cost Beneficiaries. This 3-year, six-site project began last October; the last site was launched in June, Ms. Magno said. The provider groups in the demonstration put their Medicare reimbursement at risk in exchange for guaranteeing a 5% cost savings in caring for the high-cost beneficiaries involved. Services provided include physician and nurse home visits, in-home monitoring devices, electronic medical records, caregiver support, patient education, preventive care reminders, transportation services, and 24-hour nurse telephone lines.

▸ Physician Group Practice Demonstration. This demonstration was mandated in the Benefits Improvement and Protection Act of 2000, and involves giving additional payments to providers based on practice efficiency and improved management of chronically ill patients. Participants include 10 very large multispecialty group practices nationwide with a total of more than 5,000 physicians, who care for more than 200,000 Medicare beneficiaries. The project focuses on patients with diabetes, heart failure, coronary artery disease, and hypertension. Enrollment in this project has been “very slow,” Ms. Magno said.

Two more chronic disease management demonstrations are in various stages of development. The Medicare Care Management Performance Demonstration, for example, is a pay-for-performance program that will reward physicians financially for achieving quality benchmarks for chronically ill patients and for using health information technology, including using it to report quality measures electronically. This project, which is in final review, will be implemented in Arkansas, California, Massachusetts, and Utah, Ms. Magno said.

Also in development is the Medicare Health Care Quality Demonstration. This involves using payment models that give incentives for improving the quality, safety, and efficiency of care, and incorporating things like best practice guidelines, shared decision making, and cultural competence into the practice. “This [project] is really a provider-driven opportunity to redesign the delivery system, as opposed to something externally imposed through insurers and other payers,” she said. “The goal is to achieve projects designed to implement Institute of Medicine aims for improvement” known as the STEEEP principles—safety, timeliness, effectiveness, efficiency, equity, and patient-centeredness.

PPAC member Dr. Carlos Hamilton said that the demonstration projects “raise issues so profound that they go to the very core of our health care system.” He suggested that many of the beneficiaries on whom Medicare spends more than $25,000 per year are probably in the last year of their lives, and that needless “ping-ponging” occurs when they are sent from the nursing home to the emergency department to the intensive care unit for, say, a case of sepsis.

“Addressing concerns about palliative care and end-of-life issues is critical if you're ever going to address the cost factors in terms of the overall health care system. If you can keep people from being transferred from the nursing home to the emergency [department] and the ICU in the middle of the night, you'll probably save a billion dollars right there.”

Ms. Magno agreed and noted that CMS is developing a separate demonstration project dealing with beneficiaries who are nursing home residents. The goal of the project would be “to avoid 'avoidable' hospitalizations, and to reward nursing homes for better managing care,” she said.

The other issue, said Dr. Hamilton, an endocrinologist who is executive vice president for external affairs at the University of Texas, Houston, has to do with lack of coordination of care for chronically ill patients.

“The primary care physician has been reduced to such a role in the system that nobody wants to [coordinate care] any more, and those that do quickly find out they can't afford to do that very effectively. So the system needs to strengthen the role of primary care physicians.”

PPAC member Dr. Jeffrey Ross, a Houston physician and podiatrist, asked why CMS was not looking more at preventive measures. “Why aren't we looking at preventive means [when patients are] in their 50s or when they just become beneficiaries before we do major interventional treatment later on, in the last year, when it's costing millions and millions of dollars?” he said.

For patients with diabetes, “maybe before they are diagnosed as diabetics or develop heart failure, we should be looking at exercise, looking at diet, and looking at primary care as a means to intervene before major intervention takes place.”

WASHINGTON — Medicare has a number of demonstration projects underway to help chronically ill beneficiaries get better care, and is developing more, Linda Magno said at a meeting of the Practicing Physicians Advisory Council.

Beneficiaries with chronic illnesses are a significant part of the program's budget, said Ms. Magno, director of Medicare demonstrations for the Centers for Medicare and Medicaid Services (CMS). Although beneficiaries with five or more chronic conditions make up only 20% of all beneficiaries, they account for two-thirds of Medicare spending, she noted.

With all of the spending on this population, opportunities exist for making sure the money is spent more efficiently, Ms. Magno said. Currently, CMS has three demonstration projects going in chronic care:

▸ Medicare Coordinated Care Demonstration. In this project, which was mandated by the Balanced Budget Act of 1997, the agency is examining various care coordination models that “improve quality of services to chronically ill beneficiaries and reduce Medicare expenditures.” The Health and Human Services secretary has discretion to continue or expand projects, Ms. Magno said, adding that currently 11 sites—a mix of urban and rural hospitals and long-term care facilities—are involved in this demonstration. Interventions include patient and provider education, prescription drug management, case management, and disease management.

▸ Care Management for High-Cost Beneficiaries. This 3-year, six-site project began last October; the last site was launched in June, Ms. Magno said. The provider groups in the demonstration put their Medicare reimbursement at risk in exchange for guaranteeing a 5% cost savings in caring for the high-cost beneficiaries involved. Services provided include physician and nurse home visits, in-home monitoring devices, electronic medical records, caregiver support, patient education, preventive care reminders, transportation services, and 24-hour nurse telephone lines.

▸ Physician Group Practice Demonstration. This demonstration was mandated in the Benefits Improvement and Protection Act of 2000, and involves giving additional payments to providers based on practice efficiency and improved management of chronically ill patients. Participants include 10 very large multispecialty group practices nationwide with a total of more than 5,000 physicians, who care for more than 200,000 Medicare beneficiaries. The project focuses on patients with diabetes, heart failure, coronary artery disease, and hypertension. Enrollment in this project has been “very slow,” Ms. Magno said.

Two more chronic disease management demonstrations are in various stages of development. The Medicare Care Management Performance Demonstration, for example, is a pay-for-performance program that will reward physicians financially for achieving quality benchmarks for chronically ill patients and for using health information technology, including using it to report quality measures electronically. This project, which is in final review, will be implemented in Arkansas, California, Massachusetts, and Utah, Ms. Magno said.

Also in development is the Medicare Health Care Quality Demonstration. This involves using payment models that give incentives for improving the quality, safety, and efficiency of care, and incorporating things like best practice guidelines, shared decision making, and cultural competence into the practice. “This [project] is really a provider-driven opportunity to redesign the delivery system, as opposed to something externally imposed through insurers and other payers,” she said. “The goal is to achieve projects designed to implement Institute of Medicine aims for improvement” known as the STEEEP principles—safety, timeliness, effectiveness, efficiency, equity, and patient-centeredness.

PPAC member Dr. Carlos Hamilton said that the demonstration projects “raise issues so profound that they go to the very core of our health care system.” He suggested that many of the beneficiaries on whom Medicare spends more than $25,000 per year are probably in the last year of their lives, and that needless “ping-ponging” occurs when they are sent from the nursing home to the emergency department to the intensive care unit for, say, a case of sepsis.

“Addressing concerns about palliative care and end-of-life issues is critical if you're ever going to address the cost factors in terms of the overall health care system. If you can keep people from being transferred from the nursing home to the emergency [department] and the ICU in the middle of the night, you'll probably save a billion dollars right there.”

Ms. Magno agreed and noted that CMS is developing a separate demonstration project dealing with beneficiaries who are nursing home residents. The goal of the project would be “to avoid 'avoidable' hospitalizations, and to reward nursing homes for better managing care,” she said.

The other issue, said Dr. Hamilton, an endocrinologist who is executive vice president for external affairs at the University of Texas, Houston, has to do with lack of coordination of care for chronically ill patients.

“The primary care physician has been reduced to such a role in the system that nobody wants to [coordinate care] any more, and those that do quickly find out they can't afford to do that very effectively. So the system needs to strengthen the role of primary care physicians.”

PPAC member Dr. Jeffrey Ross, a Houston physician and podiatrist, asked why CMS was not looking more at preventive measures. “Why aren't we looking at preventive means [when patients are] in their 50s or when they just become beneficiaries before we do major interventional treatment later on, in the last year, when it's costing millions and millions of dollars?” he said.

For patients with diabetes, “maybe before they are diagnosed as diabetics or develop heart failure, we should be looking at exercise, looking at diet, and looking at primary care as a means to intervene before major intervention takes place.”

WASHINGTON — Medicare has a number of demonstration projects underway to help chronically ill beneficiaries get better care, and is developing more, Linda Magno said at a meeting of the Practicing Physicians Advisory Council.

Beneficiaries with chronic illnesses are a significant part of the program's budget, said Ms. Magno, director of Medicare demonstrations for the Centers for Medicare and Medicaid Services (CMS). Although beneficiaries with five or more chronic conditions make up only 20% of all beneficiaries, they account for two-thirds of Medicare spending, she noted.

With all of the spending on this population, opportunities exist for making sure the money is spent more efficiently, Ms. Magno said. Currently, CMS has three demonstration projects going in chronic care:

▸ Medicare Coordinated Care Demonstration. In this project, which was mandated by the Balanced Budget Act of 1997, the agency is examining various care coordination models that “improve quality of services to chronically ill beneficiaries and reduce Medicare expenditures.” The Health and Human Services secretary has discretion to continue or expand projects, Ms. Magno said, adding that currently 11 sites—a mix of urban and rural hospitals and long-term care facilities—are involved in this demonstration. Interventions include patient and provider education, prescription drug management, case management, and disease management.

▸ Care Management for High-Cost Beneficiaries. This 3-year, six-site project began last October; the last site was launched in June, Ms. Magno said. The provider groups in the demonstration put their Medicare reimbursement at risk in exchange for guaranteeing a 5% cost savings in caring for the high-cost beneficiaries involved. Services provided include physician and nurse home visits, in-home monitoring devices, electronic medical records, caregiver support, patient education, preventive care reminders, transportation services, and 24-hour nurse telephone lines.

▸ Physician Group Practice Demonstration. This demonstration was mandated in the Benefits Improvement and Protection Act of 2000, and involves giving additional payments to providers based on practice efficiency and improved management of chronically ill patients. Participants include 10 very large multispecialty group practices nationwide with a total of more than 5,000 physicians, who care for more than 200,000 Medicare beneficiaries. The project focuses on patients with diabetes, heart failure, coronary artery disease, and hypertension. Enrollment in this project has been “very slow,” Ms. Magno said.

Two more chronic disease management demonstrations are in various stages of development. The Medicare Care Management Performance Demonstration, for example, is a pay-for-performance program that will reward physicians financially for achieving quality benchmarks for chronically ill patients and for using health information technology, including using it to report quality measures electronically. This project, which is in final review, will be implemented in Arkansas, California, Massachusetts, and Utah, Ms. Magno said.

Also in development is the Medicare Health Care Quality Demonstration. This involves using payment models that give incentives for improving the quality, safety, and efficiency of care, and incorporating things like best practice guidelines, shared decision making, and cultural competence into the practice. “This [project] is really a provider-driven opportunity to redesign the delivery system, as opposed to something externally imposed through insurers and other payers,” she said. “The goal is to achieve projects designed to implement Institute of Medicine aims for improvement” known as the STEEEP principles—safety, timeliness, effectiveness, efficiency, equity, and patient-centeredness.

PPAC member Dr. Carlos Hamilton said that the demonstration projects “raise issues so profound that they go to the very core of our health care system.” He suggested that many of the beneficiaries on whom Medicare spends more than $25,000 per year are probably in the last year of their lives, and that needless “ping-ponging” occurs when they are sent from the nursing home to the emergency department to the intensive care unit for, say, a case of sepsis.

“Addressing concerns about palliative care and end-of-life issues is critical if you're ever going to address the cost factors in terms of the overall health care system. If you can keep people from being transferred from the nursing home to the emergency [department] and the ICU in the middle of the night, you'll probably save a billion dollars right there.”

Ms. Magno agreed and noted that CMS is developing a separate demonstration project dealing with beneficiaries who are nursing home residents. The goal of the project would be “to avoid 'avoidable' hospitalizations, and to reward nursing homes for better managing care,” she said.

The other issue, said Dr. Hamilton, an endocrinologist who is executive vice president for external affairs at the University of Texas, Houston, has to do with lack of coordination of care for chronically ill patients.

“The primary care physician has been reduced to such a role in the system that nobody wants to [coordinate care] any more, and those that do quickly find out they can't afford to do that very effectively. So the system needs to strengthen the role of primary care physicians.”

PPAC member Dr. Jeffrey Ross, a Houston physician and podiatrist, asked why CMS was not looking more at preventive measures. “Why aren't we looking at preventive means [when patients are] in their 50s or when they just become beneficiaries before we do major interventional treatment later on, in the last year, when it's costing millions and millions of dollars?” he said.

For patients with diabetes, “maybe before they are diagnosed as diabetics or develop heart failure, we should be looking at exercise, looking at diet, and looking at primary care as a means to intervene before major intervention takes place.”

BALTIMORE — Targeting medicines at specific 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), a heart failure drug that was approved specifically for use in blacks. Some experts say that a good response to BiDil has more to do with attributes and genes than it does with self-identified race.

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, 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.

BALTIMORE — Targeting medicines at specific 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), a heart failure drug that was approved specifically for use in blacks. Some experts say that a good response to BiDil has more to do with attributes and genes than it does with self-identified race.

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, 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.

BALTIMORE — Targeting medicines at specific 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), a heart failure drug that was approved specifically for use in blacks. Some experts say that a good response to BiDil has more to do with attributes and genes than it does with self-identified race.

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, 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.

WASHINGTON — Physicians who are too nervous to completely convert their offices to electronic health records can start the process with a few “baby steps” to make it less intimidating, Dr. Daniel Sands said at a health care congress sponsored by the Wall Street Journal and CNBC.

Physicians are often reluctant to leap into an electronic health records (EHR) system because of its complexity and the expense involved, said Dr. Sands of Harvard University, Cambridge, Mass. “If you're a doctor, what do you do? How do you get that [EHR system] if you can't take the one big leap?”

One way to start is by using electronic communications with patients and with office staff, he said.

“Why don't you get rid of those stupid yellow Post-It notes you use for phone messages? A simple step like that is a good way to get people engaged with technology.”

Electronic prescribing is another way to bridge the gap, said Dr. Sands, who is also chief medical officer of ZixCorp, a Newton, Mass., company that sells electronic prescribing software.

Medications can be prescribed using various electronic devices, including desktop and laptop computers, handhelds, and even mobile phones. Since studies have shown that electronic prescribing can reduce medication errors substantially, “this should be the standard of care,” he said.

Another baby step physicians can take is to use online clinical reference materials, Dr. Sands continued.

“We have lots of data showing that physicians are often faced with questions when taking care of patients, and they can't find the answers because they don't have time, so they just move on. And that's really scary.”

Rather than looking for answers “in a book that's out of date as soon as it's printed, maybe looking online would be a great place to start,” Dr. Sands said.

WASHINGTON — Physicians who are too nervous to completely convert their offices to electronic health records can start the process with a few “baby steps” to make it less intimidating, Dr. Daniel Sands said at a health care congress sponsored by the Wall Street Journal and CNBC.

Physicians are often reluctant to leap into an electronic health records (EHR) system because of its complexity and the expense involved, said Dr. Sands of Harvard University, Cambridge, Mass. “If you're a doctor, what do you do? How do you get that [EHR system] if you can't take the one big leap?”

One way to start is by using electronic communications with patients and with office staff, he said.

“Why don't you get rid of those stupid yellow Post-It notes you use for phone messages? A simple step like that is a good way to get people engaged with technology.”

Electronic prescribing is another way to bridge the gap, said Dr. Sands, who is also chief medical officer of ZixCorp, a Newton, Mass., company that sells electronic prescribing software.

Medications can be prescribed using various electronic devices, including desktop and laptop computers, handhelds, and even mobile phones. Since studies have shown that electronic prescribing can reduce medication errors substantially, “this should be the standard of care,” he said.

Another baby step physicians can take is to use online clinical reference materials, Dr. Sands continued.

“We have lots of data showing that physicians are often faced with questions when taking care of patients, and they can't find the answers because they don't have time, so they just move on. And that's really scary.”

Rather than looking for answers “in a book that's out of date as soon as it's printed, maybe looking online would be a great place to start,” Dr. Sands said.

WASHINGTON — Physicians who are too nervous to completely convert their offices to electronic health records can start the process with a few “baby steps” to make it less intimidating, Dr. Daniel Sands said at a health care congress sponsored by the Wall Street Journal and CNBC.

Physicians are often reluctant to leap into an electronic health records (EHR) system because of its complexity and the expense involved, said Dr. Sands of Harvard University, Cambridge, Mass. “If you're a doctor, what do you do? How do you get that [EHR system] if you can't take the one big leap?”

One way to start is by using electronic communications with patients and with office staff, he said.

“Why don't you get rid of those stupid yellow Post-It notes you use for phone messages? A simple step like that is a good way to get people engaged with technology.”

Electronic prescribing is another way to bridge the gap, said Dr. Sands, who is also chief medical officer of ZixCorp, a Newton, Mass., company that sells electronic prescribing software.

Medications can be prescribed using various electronic devices, including desktop and laptop computers, handhelds, and even mobile phones. Since studies have shown that electronic prescribing can reduce medication errors substantially, “this should be the standard of care,” he said.

Another baby step physicians can take is to use online clinical reference materials, Dr. Sands continued.

“We have lots of data showing that physicians are often faced with questions when taking care of patients, and they can't find the answers because they don't have time, so they just move on. And that's really scary.”

Rather than looking for answers “in a book that's out of date as soon as it's printed, maybe looking online would be a great place to start,” Dr. Sands 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, Ms. Hoffman said.

Society also has difficulty defining race, with legal definitions of race varying from one state to another, Ms. Hoffman noted. 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 said.

“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 noted.

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, Ms. Hoffman said.

Society also has difficulty defining race, with legal definitions of race varying from one state to another, Ms. Hoffman noted. 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 said.

“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 noted.

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, Ms. Hoffman said.

Society also has difficulty defining race, with legal definitions of race varying from one state to another, Ms. Hoffman noted. 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 said.

“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 noted.

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, there are some things physicians are allowed to do, 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 track 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, 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, there are some things physicians are allowed to do, 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 track 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, 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, there are some things physicians are allowed to do, 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 track 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, 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.