Alicia Ault

WASHINGTON — Food and Drug Administration officials said in March they have started several new initiatives in response to the Institute of Medicine's call to upgrade and overhaul its drug safety efforts.

The projects, including a pilot project to more closely monitor the postmarketing safety of four new molecular entities and a plan to put more postmarketing data on the agency's Web site, were revealed at a meeting sponsored by the IOM.

In a September 2006 report that lambasted the FDA's safety oversight, the IOM called on the agency to issue an interim report on selected drugs' postmarketing safety at least 18 months, and no longer than 5 years, after launch.

“Five years is too late to find out what a drug is doing,” said Dr. Robert Temple, the FDA's associate director for medical policy. The Center for Drug Evaluation and Research (CDER) has begun a pilot project with four new molecular entities to gather data at 1, 2, and 3 years after launch, he said. He declined to name the drugs.

The agency also plans to publish a newsletter on its Web site to provide up-to-date information on a drug's postmarketing experience, said Dr. Ellis Unger, acting deputy director for science at CDER's Office of Surveillance and Epidemiology.

The IOM report also urged Congress to give the FDA greater and more precise enforcement powers, partly to compel drug manufacturers to fulfill their commitments to gather postmarketing data.

Peter Barton Hutt, a former FDA general counsel and now senior counsel with Covington & Burling in Washington, said the agency already has all the enforcement power it needs, but that it needs more funding outside of the user fees it collects.

Critics have said the agency is unduly beholden to industry because of user fees. Former FDA Deputy Commissioner Mary Pendergast said those fees were likely to make up 80% of the agency's drug review and safety budget if Congress did not provide additional money for 2007.

In a report to Congress (fiscal 2006), 63% of postmarketing studies had not been started. The agency needs a better hammer to get those studies done, she said.

WASHINGTON — Food and Drug Administration officials said in March they have started several new initiatives in response to the Institute of Medicine's call to upgrade and overhaul its drug safety efforts.

The projects, including a pilot project to more closely monitor the postmarketing safety of four new molecular entities and a plan to put more postmarketing data on the agency's Web site, were revealed at a meeting sponsored by the IOM.

In a September 2006 report that lambasted the FDA's safety oversight, the IOM called on the agency to issue an interim report on selected drugs' postmarketing safety at least 18 months, and no longer than 5 years, after launch.

“Five years is too late to find out what a drug is doing,” said Dr. Robert Temple, the FDA's associate director for medical policy. The Center for Drug Evaluation and Research (CDER) has begun a pilot project with four new molecular entities to gather data at 1, 2, and 3 years after launch, he said. He declined to name the drugs.

The agency also plans to publish a newsletter on its Web site to provide up-to-date information on a drug's postmarketing experience, said Dr. Ellis Unger, acting deputy director for science at CDER's Office of Surveillance and Epidemiology.

The IOM report also urged Congress to give the FDA greater and more precise enforcement powers, partly to compel drug manufacturers to fulfill their commitments to gather postmarketing data.

Peter Barton Hutt, a former FDA general counsel and now senior counsel with Covington & Burling in Washington, said the agency already has all the enforcement power it needs, but that it needs more funding outside of the user fees it collects.

Critics have said the agency is unduly beholden to industry because of user fees. Former FDA Deputy Commissioner Mary Pendergast said those fees were likely to make up 80% of the agency's drug review and safety budget if Congress did not provide additional money for 2007.

In a report to Congress (fiscal 2006), 63% of postmarketing studies had not been started. The agency needs a better hammer to get those studies done, she said.

WASHINGTON — Food and Drug Administration officials said in March they have started several new initiatives in response to the Institute of Medicine's call to upgrade and overhaul its drug safety efforts.

The projects, including a pilot project to more closely monitor the postmarketing safety of four new molecular entities and a plan to put more postmarketing data on the agency's Web site, were revealed at a meeting sponsored by the IOM.

In a September 2006 report that lambasted the FDA's safety oversight, the IOM called on the agency to issue an interim report on selected drugs' postmarketing safety at least 18 months, and no longer than 5 years, after launch.

“Five years is too late to find out what a drug is doing,” said Dr. Robert Temple, the FDA's associate director for medical policy. The Center for Drug Evaluation and Research (CDER) has begun a pilot project with four new molecular entities to gather data at 1, 2, and 3 years after launch, he said. He declined to name the drugs.

The agency also plans to publish a newsletter on its Web site to provide up-to-date information on a drug's postmarketing experience, said Dr. Ellis Unger, acting deputy director for science at CDER's Office of Surveillance and Epidemiology.

The IOM report also urged Congress to give the FDA greater and more precise enforcement powers, partly to compel drug manufacturers to fulfill their commitments to gather postmarketing data.

Peter Barton Hutt, a former FDA general counsel and now senior counsel with Covington & Burling in Washington, said the agency already has all the enforcement power it needs, but that it needs more funding outside of the user fees it collects.

Critics have said the agency is unduly beholden to industry because of user fees. Former FDA Deputy Commissioner Mary Pendergast said those fees were likely to make up 80% of the agency's drug review and safety budget if Congress did not provide additional money for 2007.

In a report to Congress (fiscal 2006), 63% of postmarketing studies had not been started. The agency needs a better hammer to get those studies done, she said.

NEW ORLEANS — An American Red Cross program that offers subsidies for mental health care to people affected by hurricanes on the Gulf Coast has been so undersubscribed that the organization is extending the deadline to apply and the period in which benefits will be offered by 6 months.

The Red Cross also has doubled the amount of money available to each applicant—from $1,000 to $2,000.

Anyone—even if he or she did not live in one of the affected Zip codes—who lost a family member may be eligible to receive benefits.

The organization is reluctant to give out figures on how many people have used benefits under the Access to Care program and how many it hopes to accommodate. Jeanne Ellinport, director of communications for hurricane recovery at the Red Cross, said in an interview that there is a cap on the amount of money that will be distributed, but that the program has not come close to reaching that limit.

One psychiatrist who's been trying to get the word out about the program—Dr. Grayson S. Norquist, professor and chairman of the department of psychiatry and human behavior at the University of Mississippi Medical Center in Jackson—said he had been told that as many as 40,000 people could receive benefits and that only about half that many have done so.

Access to Care was launched in late September 2006, about a year after hurricanes Katrina, Rita, and Wilma ravaged the Gulf Coast of Louisiana and Mississippi, as well as New Orleans and parts of Alabama, Florida, and Texas. It was modeled after a program instituted in New York after the attacks of Sept. 11, 2001, according to Jacqueline Yannacci, program manager, emotional support for recovery, at the Red Cross.

Both the Sept. 11 program and the hurricane-related program are administered by the Mental Health Association of New York City.

Past experience has shown that depression, anxiety, and posttraumatic stress disorder tend to hit the hardest about a year after a disaster, hence the September 2006 launch, Ms. Yannacci said.

Those eligible for Access to Care are people who lived, before the hurricanes hit, in a Zip code affected by one of the three storms—about 133 counties in Texas, Louisiana, Mississippi, Alabama, and south Florida, Ms. Yannacci said. The residents have to provide proof of residence in those areas before the storm. While that might be close to impossible for storm victims whose homes were flooded or wiped out by winds or a storm surge, Ms. Yannacci said the Red Cross does everything possible to help people get proof. Those who received assistance from the Red Cross are in an organization database; in some instances, case managers call utilities or do other detective work to get residency proof, she said.

Applicants have to show that the storms had a significant impact on their lives—for instance, that they had been displaced from their homes for longer than 2 weeks, had lost their home or job, or their children had been uprooted and placed in a new school. If the “significant impact” criteria are met, even people who no longer live in those areas are eligible.

Initially, applications had to be received by Oct. 1, 2007; that has now been extended to March 30, 2008. Services will be covered from Aug. 30, 2005, to Sept. 30, 2008—instead of April 1, 2008. Claims can be filed as late as Dec. 30, 2008.

The Red Cross also removed a big potential hurdle for applicants. Initially, they had to use insurance benefits—if they had them—before they could receive Access to Care funds. Now, if they are accepted into the program, applicants can make use of up to $2,000 without using their insurance first. The payments can be made directly to providers—psychiatrists, social workers, psychologists, even acupuncturists. The money can be used for counseling, acupuncture, testing and evaluation of children up to age 21, and psychotropic medications.

Dr. Norquist said few of those who might use Access to Care—and few of his psychiatric colleagues on the Gulf Coast—know about the program, he said in an interview.

A major issue for Gulf Coast residents who might want to seek psychiatric care is the continuing shortage of health providers. Mississippi Gulf Coast clinics have about 75% of the staff they had before the hurricane, and they are seeing as many or more patients, Dr. Norquist said.

Meanwhile, the Metropolitan Human Services District (MHSD), a semiregional agency in charge of providing and managing publicly provided mental health and substance abuse services, is collaborating with the Red Cross to increase awareness of Access to Care. But a change in strategy might be needed, said Dr. Jerome Gibbs, executive director of the MHSD. “We need to think about how we market and label the services we provide,” he said, noting that for many people, there is still a stigma attached to seeking care for a mental health issue.

For more information about the Access to Care program, go to www.a2care.com

NEW ORLEANS — An American Red Cross program that offers subsidies for mental health care to people affected by hurricanes on the Gulf Coast has been so undersubscribed that the organization is extending the deadline to apply and the period in which benefits will be offered by 6 months.

The Red Cross also has doubled the amount of money available to each applicant—from $1,000 to $2,000.

Anyone—even if he or she did not live in one of the affected Zip codes—who lost a family member may be eligible to receive benefits.

The organization is reluctant to give out figures on how many people have used benefits under the Access to Care program and how many it hopes to accommodate. Jeanne Ellinport, director of communications for hurricane recovery at the Red Cross, said in an interview that there is a cap on the amount of money that will be distributed, but that the program has not come close to reaching that limit.

One psychiatrist who's been trying to get the word out about the program—Dr. Grayson S. Norquist, professor and chairman of the department of psychiatry and human behavior at the University of Mississippi Medical Center in Jackson—said he had been told that as many as 40,000 people could receive benefits and that only about half that many have done so.

Access to Care was launched in late September 2006, about a year after hurricanes Katrina, Rita, and Wilma ravaged the Gulf Coast of Louisiana and Mississippi, as well as New Orleans and parts of Alabama, Florida, and Texas. It was modeled after a program instituted in New York after the attacks of Sept. 11, 2001, according to Jacqueline Yannacci, program manager, emotional support for recovery, at the Red Cross.

Both the Sept. 11 program and the hurricane-related program are administered by the Mental Health Association of New York City.

Past experience has shown that depression, anxiety, and posttraumatic stress disorder tend to hit the hardest about a year after a disaster, hence the September 2006 launch, Ms. Yannacci said.

Those eligible for Access to Care are people who lived, before the hurricanes hit, in a Zip code affected by one of the three storms—about 133 counties in Texas, Louisiana, Mississippi, Alabama, and south Florida, Ms. Yannacci said. The residents have to provide proof of residence in those areas before the storm. While that might be close to impossible for storm victims whose homes were flooded or wiped out by winds or a storm surge, Ms. Yannacci said the Red Cross does everything possible to help people get proof. Those who received assistance from the Red Cross are in an organization database; in some instances, case managers call utilities or do other detective work to get residency proof, she said.

Applicants have to show that the storms had a significant impact on their lives—for instance, that they had been displaced from their homes for longer than 2 weeks, had lost their home or job, or their children had been uprooted and placed in a new school. If the “significant impact” criteria are met, even people who no longer live in those areas are eligible.

Initially, applications had to be received by Oct. 1, 2007; that has now been extended to March 30, 2008. Services will be covered from Aug. 30, 2005, to Sept. 30, 2008—instead of April 1, 2008. Claims can be filed as late as Dec. 30, 2008.

The Red Cross also removed a big potential hurdle for applicants. Initially, they had to use insurance benefits—if they had them—before they could receive Access to Care funds. Now, if they are accepted into the program, applicants can make use of up to $2,000 without using their insurance first. The payments can be made directly to providers—psychiatrists, social workers, psychologists, even acupuncturists. The money can be used for counseling, acupuncture, testing and evaluation of children up to age 21, and psychotropic medications.

Dr. Norquist said few of those who might use Access to Care—and few of his psychiatric colleagues on the Gulf Coast—know about the program, he said in an interview.

A major issue for Gulf Coast residents who might want to seek psychiatric care is the continuing shortage of health providers. Mississippi Gulf Coast clinics have about 75% of the staff they had before the hurricane, and they are seeing as many or more patients, Dr. Norquist said.

Meanwhile, the Metropolitan Human Services District (MHSD), a semiregional agency in charge of providing and managing publicly provided mental health and substance abuse services, is collaborating with the Red Cross to increase awareness of Access to Care. But a change in strategy might be needed, said Dr. Jerome Gibbs, executive director of the MHSD. “We need to think about how we market and label the services we provide,” he said, noting that for many people, there is still a stigma attached to seeking care for a mental health issue.

For more information about the Access to Care program, go to www.a2care.com

NEW ORLEANS — An American Red Cross program that offers subsidies for mental health care to people affected by hurricanes on the Gulf Coast has been so undersubscribed that the organization is extending the deadline to apply and the period in which benefits will be offered by 6 months.

The Red Cross also has doubled the amount of money available to each applicant—from $1,000 to $2,000.

Anyone—even if he or she did not live in one of the affected Zip codes—who lost a family member may be eligible to receive benefits.

The organization is reluctant to give out figures on how many people have used benefits under the Access to Care program and how many it hopes to accommodate. Jeanne Ellinport, director of communications for hurricane recovery at the Red Cross, said in an interview that there is a cap on the amount of money that will be distributed, but that the program has not come close to reaching that limit.

One psychiatrist who's been trying to get the word out about the program—Dr. Grayson S. Norquist, professor and chairman of the department of psychiatry and human behavior at the University of Mississippi Medical Center in Jackson—said he had been told that as many as 40,000 people could receive benefits and that only about half that many have done so.

Access to Care was launched in late September 2006, about a year after hurricanes Katrina, Rita, and Wilma ravaged the Gulf Coast of Louisiana and Mississippi, as well as New Orleans and parts of Alabama, Florida, and Texas. It was modeled after a program instituted in New York after the attacks of Sept. 11, 2001, according to Jacqueline Yannacci, program manager, emotional support for recovery, at the Red Cross.

Both the Sept. 11 program and the hurricane-related program are administered by the Mental Health Association of New York City.

Past experience has shown that depression, anxiety, and posttraumatic stress disorder tend to hit the hardest about a year after a disaster, hence the September 2006 launch, Ms. Yannacci said.

Those eligible for Access to Care are people who lived, before the hurricanes hit, in a Zip code affected by one of the three storms—about 133 counties in Texas, Louisiana, Mississippi, Alabama, and south Florida, Ms. Yannacci said. The residents have to provide proof of residence in those areas before the storm. While that might be close to impossible for storm victims whose homes were flooded or wiped out by winds or a storm surge, Ms. Yannacci said the Red Cross does everything possible to help people get proof. Those who received assistance from the Red Cross are in an organization database; in some instances, case managers call utilities or do other detective work to get residency proof, she said.

Applicants have to show that the storms had a significant impact on their lives—for instance, that they had been displaced from their homes for longer than 2 weeks, had lost their home or job, or their children had been uprooted and placed in a new school. If the “significant impact” criteria are met, even people who no longer live in those areas are eligible.

Initially, applications had to be received by Oct. 1, 2007; that has now been extended to March 30, 2008. Services will be covered from Aug. 30, 2005, to Sept. 30, 2008—instead of April 1, 2008. Claims can be filed as late as Dec. 30, 2008.

The Red Cross also removed a big potential hurdle for applicants. Initially, they had to use insurance benefits—if they had them—before they could receive Access to Care funds. Now, if they are accepted into the program, applicants can make use of up to $2,000 without using their insurance first. The payments can be made directly to providers—psychiatrists, social workers, psychologists, even acupuncturists. The money can be used for counseling, acupuncture, testing and evaluation of children up to age 21, and psychotropic medications.

Dr. Norquist said few of those who might use Access to Care—and few of his psychiatric colleagues on the Gulf Coast—know about the program, he said in an interview.

A major issue for Gulf Coast residents who might want to seek psychiatric care is the continuing shortage of health providers. Mississippi Gulf Coast clinics have about 75% of the staff they had before the hurricane, and they are seeing as many or more patients, Dr. Norquist said.

Meanwhile, the Metropolitan Human Services District (MHSD), a semiregional agency in charge of providing and managing publicly provided mental health and substance abuse services, is collaborating with the Red Cross to increase awareness of Access to Care. But a change in strategy might be needed, said Dr. Jerome Gibbs, executive director of the MHSD. “We need to think about how we market and label the services we provide,” he said, noting that for many people, there is still a stigma attached to seeking care for a mental health issue.

For more information about the Access to Care program, go to www.a2care.com

WASHINGTON — Several individual physicians and professional organizations urged members of Congress to extend tax credits or deductions and small business loans to physicians who purchase information systems and to require Medicare to offer incentive payments to physicians who adopt electronic medical records.

Electronic medical records (EMRs) can make practices more efficient, but the initial expense—both monetary and in staff training—can be devastating to small physician offices, the witnesses told the panel members at a House Small Business Subcommittee on Regulation, Healthcare and Trade hearing.

Subcommittee chairman Charles Gonzalez (D-Tex.) agreed that the federal government should give physicians some kind of financial carrot to invest in health information technology. “Without changes in the way we promote health IT, small physician practices will be left behind the technological curve, and as a result, patients will fail to benefit from the quality of care electronic health records provide,” said Mr. Gonzalez, who recently reintroduced his National Health Information Incentive Act. The bill was aimed at assisting smaller practices but would also direct Medicare to make add-on payments for office visits facilitated by EMRs.

The American College of Physicians has called for just such a payment for several years, Dr. Lynne Kirk, ACP president, said at the hearing.

Mr. Gonzalez noted that the full Small Business Committee had recently passed the Small Business Lending Improvements Act of 2007 (H.R. 1332). The bill would let small practices borrow from the Small Business Administration to finance information systems.

Coming up with the capital for health IT is particularly tough for smaller physician groups, Dr. Kirk noted. One 2006 study showed that only 13%–16% of solo practitioners had adopted health IT, she said. Small practices are the lifeblood of internal medicine, she said, adding that 20% of internists are in solo practices and 50% are in practices of five or fewer physicians.

Acquisition costs average $44,000 per physician and yearly upkeep amounts to about $8,500 per physician, according to a 2005 study published in Health Affairs, Dr. Kirk said. ACP advocates an add-on payment from Medicare scaled to the complexity of the technology, as well as grants, loans, or tax credits from the federal government, Dr. Kirk said.

The lack of reimbursement for using health IT is a major obstacle to adoption, said Dr. Mark Leavitt, chairman of the Certification Commission for Healthcare Information Technology, a publicly funded agency that for the last year has been vetting hardware and software systems. CCHIT has certified 57 office-based systems, he said. Some payers are now offering financial incentives to physicians who use these certified systems, Dr. Leavitt said.

Dr. Margaret Kelley, an obstetrician in a two-person practice with her father in San Antonio, said they had spent $100,000 to purchase an EMR system. Initially, the system devastated the practice's efficiency, said Dr. Kelley, who also spoke on behalf of the American College of Obstetricians and Gynecologists.

“It took our practice nearly 2 years to be able to accommodate as many patients as we could before we invested in our EMR system,” Dr. Kelley said. Even so, they would not consider returning to their old way of practice, noting that one of the biggest benefits has been access to patient charts 24 hours a day, she said.

Dr. David O. Shober said that implementing an EMR system at his two-physician family practice has been draining but beneficial. In 2004, the practice—four physicians and two offices—spent $200,000 to buy a system. Yearly costs have averaged $50,000–$60,000, said Dr. Shober, who is based in New Castle, Pa. The system has allowed the practice to create more thorough notes, standardize charts, and retrieve records easily and quickly. But the system can't communicate with radiology centers and labs, and many local pharmacies refuse to accept an e-prescription, he said.

“The only way to provide incentives for the adoption of health IT is to provide financial assistance,” said Dr. Shober, adding that the federal government should make no-interest loans available.

Dr. Kevin Napier, an internist in a nine-physician family and internal medicine practice in Griffin, Ga., said that he and his colleagues had spent $400,000 for the purchase of a system and subsequent training since 2005. There was a huge drop in patient volume and income the first year of implementation, but the benefits have outweighed the risks, Dr. Napier said.

WASHINGTON — Several individual physicians and professional organizations urged members of Congress to extend tax credits or deductions and small business loans to physicians who purchase information systems and to require Medicare to offer incentive payments to physicians who adopt electronic medical records.

Electronic medical records (EMRs) can make practices more efficient, but the initial expense—both monetary and in staff training—can be devastating to small physician offices, the witnesses told the panel members at a House Small Business Subcommittee on Regulation, Healthcare and Trade hearing.

Subcommittee chairman Charles Gonzalez (D-Tex.) agreed that the federal government should give physicians some kind of financial carrot to invest in health information technology. “Without changes in the way we promote health IT, small physician practices will be left behind the technological curve, and as a result, patients will fail to benefit from the quality of care electronic health records provide,” said Mr. Gonzalez, who recently reintroduced his National Health Information Incentive Act. The bill was aimed at assisting smaller practices but would also direct Medicare to make add-on payments for office visits facilitated by EMRs.

The American College of Physicians has called for just such a payment for several years, Dr. Lynne Kirk, ACP president, said at the hearing.

Mr. Gonzalez noted that the full Small Business Committee had recently passed the Small Business Lending Improvements Act of 2007 (H.R. 1332). The bill would let small practices borrow from the Small Business Administration to finance information systems.

Coming up with the capital for health IT is particularly tough for smaller physician groups, Dr. Kirk noted. One 2006 study showed that only 13%–16% of solo practitioners had adopted health IT, she said. Small practices are the lifeblood of internal medicine, she said, adding that 20% of internists are in solo practices and 50% are in practices of five or fewer physicians.

Acquisition costs average $44,000 per physician and yearly upkeep amounts to about $8,500 per physician, according to a 2005 study published in Health Affairs, Dr. Kirk said. ACP advocates an add-on payment from Medicare scaled to the complexity of the technology, as well as grants, loans, or tax credits from the federal government, Dr. Kirk said.

The lack of reimbursement for using health IT is a major obstacle to adoption, said Dr. Mark Leavitt, chairman of the Certification Commission for Healthcare Information Technology, a publicly funded agency that for the last year has been vetting hardware and software systems. CCHIT has certified 57 office-based systems, he said. Some payers are now offering financial incentives to physicians who use these certified systems, Dr. Leavitt said.

Dr. Margaret Kelley, an obstetrician in a two-person practice with her father in San Antonio, said they had spent $100,000 to purchase an EMR system. Initially, the system devastated the practice's efficiency, said Dr. Kelley, who also spoke on behalf of the American College of Obstetricians and Gynecologists.

“It took our practice nearly 2 years to be able to accommodate as many patients as we could before we invested in our EMR system,” Dr. Kelley said. Even so, they would not consider returning to their old way of practice, noting that one of the biggest benefits has been access to patient charts 24 hours a day, she said.

Dr. David O. Shober said that implementing an EMR system at his two-physician family practice has been draining but beneficial. In 2004, the practice—four physicians and two offices—spent $200,000 to buy a system. Yearly costs have averaged $50,000–$60,000, said Dr. Shober, who is based in New Castle, Pa. The system has allowed the practice to create more thorough notes, standardize charts, and retrieve records easily and quickly. But the system can't communicate with radiology centers and labs, and many local pharmacies refuse to accept an e-prescription, he said.

“The only way to provide incentives for the adoption of health IT is to provide financial assistance,” said Dr. Shober, adding that the federal government should make no-interest loans available.

Dr. Kevin Napier, an internist in a nine-physician family and internal medicine practice in Griffin, Ga., said that he and his colleagues had spent $400,000 for the purchase of a system and subsequent training since 2005. There was a huge drop in patient volume and income the first year of implementation, but the benefits have outweighed the risks, Dr. Napier said.

WASHINGTON — Several individual physicians and professional organizations urged members of Congress to extend tax credits or deductions and small business loans to physicians who purchase information systems and to require Medicare to offer incentive payments to physicians who adopt electronic medical records.

Electronic medical records (EMRs) can make practices more efficient, but the initial expense—both monetary and in staff training—can be devastating to small physician offices, the witnesses told the panel members at a House Small Business Subcommittee on Regulation, Healthcare and Trade hearing.

Subcommittee chairman Charles Gonzalez (D-Tex.) agreed that the federal government should give physicians some kind of financial carrot to invest in health information technology. “Without changes in the way we promote health IT, small physician practices will be left behind the technological curve, and as a result, patients will fail to benefit from the quality of care electronic health records provide,” said Mr. Gonzalez, who recently reintroduced his National Health Information Incentive Act. The bill was aimed at assisting smaller practices but would also direct Medicare to make add-on payments for office visits facilitated by EMRs.

The American College of Physicians has called for just such a payment for several years, Dr. Lynne Kirk, ACP president, said at the hearing.

Mr. Gonzalez noted that the full Small Business Committee had recently passed the Small Business Lending Improvements Act of 2007 (H.R. 1332). The bill would let small practices borrow from the Small Business Administration to finance information systems.

Coming up with the capital for health IT is particularly tough for smaller physician groups, Dr. Kirk noted. One 2006 study showed that only 13%–16% of solo practitioners had adopted health IT, she said. Small practices are the lifeblood of internal medicine, she said, adding that 20% of internists are in solo practices and 50% are in practices of five or fewer physicians.

Acquisition costs average $44,000 per physician and yearly upkeep amounts to about $8,500 per physician, according to a 2005 study published in Health Affairs, Dr. Kirk said. ACP advocates an add-on payment from Medicare scaled to the complexity of the technology, as well as grants, loans, or tax credits from the federal government, Dr. Kirk said.

The lack of reimbursement for using health IT is a major obstacle to adoption, said Dr. Mark Leavitt, chairman of the Certification Commission for Healthcare Information Technology, a publicly funded agency that for the last year has been vetting hardware and software systems. CCHIT has certified 57 office-based systems, he said. Some payers are now offering financial incentives to physicians who use these certified systems, Dr. Leavitt said.

Dr. Margaret Kelley, an obstetrician in a two-person practice with her father in San Antonio, said they had spent $100,000 to purchase an EMR system. Initially, the system devastated the practice's efficiency, said Dr. Kelley, who also spoke on behalf of the American College of Obstetricians and Gynecologists.

“It took our practice nearly 2 years to be able to accommodate as many patients as we could before we invested in our EMR system,” Dr. Kelley said. Even so, they would not consider returning to their old way of practice, noting that one of the biggest benefits has been access to patient charts 24 hours a day, she said.

Dr. David O. Shober said that implementing an EMR system at his two-physician family practice has been draining but beneficial. In 2004, the practice—four physicians and two offices—spent $200,000 to buy a system. Yearly costs have averaged $50,000–$60,000, said Dr. Shober, who is based in New Castle, Pa. The system has allowed the practice to create more thorough notes, standardize charts, and retrieve records easily and quickly. But the system can't communicate with radiology centers and labs, and many local pharmacies refuse to accept an e-prescription, he said.

“The only way to provide incentives for the adoption of health IT is to provide financial assistance,” said Dr. Shober, adding that the federal government should make no-interest loans available.

Dr. Kevin Napier, an internist in a nine-physician family and internal medicine practice in Griffin, Ga., said that he and his colleagues had spent $400,000 for the purchase of a system and subsequent training since 2005. There was a huge drop in patient volume and income the first year of implementation, but the benefits have outweighed the risks, Dr. Napier said.

WASHINGTON — The U.S. health care delivery system should be overhauled to organize medical practice around “integrated care cycles” that are coordinated by a central physician and to reward physicians for providing value, Michael E. Porter said at a media briefing presented by the Journal of the American Medical Association.

The proposals are a shortened version of a book written by Mr. Porter, the Bishop William Lawrence University Professor at Harvard Business School, and his coauthor, Elizabeth Olmsted Teisberg of the University of Virginia's Darden Graduate School of Business.

According to Mr. Porter and Ms. Teisberg, a value-based system has three principles: providing value for patients, organizing delivery of care around conditions and care cycles, and measuring results, preferably risk-adjusted outcomes that are measured over the full cycle of care, not just an individual care episode (JAMA 2007;297:1103–11).

“Physicians focused on value for patients will no longer see themselves as self-contained, isolated actors,” the authors wrote. “Instead, they will build stronger professional connections with complementary specialists who contribute to patient care across the care cycles for their patients.”

The authors pointed out that they do not advocate a single-payer system. They say instead that competition is healthy but the current system supports the wrong kind of competition.

It rewards physicians and health plans for taking patients away from one another or for shifting costs onto a competitor, rather than for providing value for the patient in the form of improved clinical outcomes, the authors said.

Their model is similar to the medical home concept that's being promoted by the American College of Physicians and the American Academy of Family Physicians. Under the concept, physicians would provide a bundled payment to a physician to coordinate care and there would be a pay-for-performance element based on patient outcomes.

Medicare will pay for a 3-year, eight-state demonstration of the medical home, and ACP and AAFP are working with IBM on testing such a program with its employees in Austin, Tex.

Physicians are in the best position to change the delivery of health care, Mr. Porter and Ms. Teisberg said. They could lead by becoming part of a care team and agreeing to accept a piece of a payment that would be bundled for the episode of care, not for an individual service. And they can take the lead in defining outcomes measurements, Mr. Porter said at the briefing.

In the article, the authors said that pay-for-performance models are also going down the wrong track, because they are aimed only at getting physicians to comply with processes of care. That will not provide value to the patient and will likely lead to micromanagement of medical practice, they said.

A study published the same week in the New England Journal of Medicine found that pay-for-performance proposals under Medicare aren't likely to work well under the current system, because patients' care is not being coordinated by a single provider. In fact, beneficiaries are seeing multiple physicians—typically seven physicians in four practices in a given year—which “impedes the ability of any one assigned provider to influence the overall quality of care for a given patient,” wrote the investigators, who were with the Center for Studying Health System Change and Memorial Sloan-Kettering Cancer Center (N. Engl. J. Med. 2007;356:1130–9).

Mr. Porter and Ms. Teisberg envision a future where care is delivered efficiently by physicians allied in partnerships or working for large group practices or staff-model managed care organizations.

WASHINGTON — The U.S. health care delivery system should be overhauled to organize medical practice around “integrated care cycles” that are coordinated by a central physician and to reward physicians for providing value, Michael E. Porter said at a media briefing presented by the Journal of the American Medical Association.

The proposals are a shortened version of a book written by Mr. Porter, the Bishop William Lawrence University Professor at Harvard Business School, and his coauthor, Elizabeth Olmsted Teisberg of the University of Virginia's Darden Graduate School of Business.

According to Mr. Porter and Ms. Teisberg, a value-based system has three principles: providing value for patients, organizing delivery of care around conditions and care cycles, and measuring results, preferably risk-adjusted outcomes that are measured over the full cycle of care, not just an individual care episode (JAMA 2007;297:1103–11).

“Physicians focused on value for patients will no longer see themselves as self-contained, isolated actors,” the authors wrote. “Instead, they will build stronger professional connections with complementary specialists who contribute to patient care across the care cycles for their patients.”

The authors pointed out that they do not advocate a single-payer system. They say instead that competition is healthy but the current system supports the wrong kind of competition.

It rewards physicians and health plans for taking patients away from one another or for shifting costs onto a competitor, rather than for providing value for the patient in the form of improved clinical outcomes, the authors said.

Their model is similar to the medical home concept that's being promoted by the American College of Physicians and the American Academy of Family Physicians. Under the concept, physicians would provide a bundled payment to a physician to coordinate care and there would be a pay-for-performance element based on patient outcomes.

Medicare will pay for a 3-year, eight-state demonstration of the medical home, and ACP and AAFP are working with IBM on testing such a program with its employees in Austin, Tex.

Physicians are in the best position to change the delivery of health care, Mr. Porter and Ms. Teisberg said. They could lead by becoming part of a care team and agreeing to accept a piece of a payment that would be bundled for the episode of care, not for an individual service. And they can take the lead in defining outcomes measurements, Mr. Porter said at the briefing.

In the article, the authors said that pay-for-performance models are also going down the wrong track, because they are aimed only at getting physicians to comply with processes of care. That will not provide value to the patient and will likely lead to micromanagement of medical practice, they said.

A study published the same week in the New England Journal of Medicine found that pay-for-performance proposals under Medicare aren't likely to work well under the current system, because patients' care is not being coordinated by a single provider. In fact, beneficiaries are seeing multiple physicians—typically seven physicians in four practices in a given year—which “impedes the ability of any one assigned provider to influence the overall quality of care for a given patient,” wrote the investigators, who were with the Center for Studying Health System Change and Memorial Sloan-Kettering Cancer Center (N. Engl. J. Med. 2007;356:1130–9).

Mr. Porter and Ms. Teisberg envision a future where care is delivered efficiently by physicians allied in partnerships or working for large group practices or staff-model managed care organizations.

WASHINGTON — The U.S. health care delivery system should be overhauled to organize medical practice around “integrated care cycles” that are coordinated by a central physician and to reward physicians for providing value, Michael E. Porter said at a media briefing presented by the Journal of the American Medical Association.

The proposals are a shortened version of a book written by Mr. Porter, the Bishop William Lawrence University Professor at Harvard Business School, and his coauthor, Elizabeth Olmsted Teisberg of the University of Virginia's Darden Graduate School of Business.

According to Mr. Porter and Ms. Teisberg, a value-based system has three principles: providing value for patients, organizing delivery of care around conditions and care cycles, and measuring results, preferably risk-adjusted outcomes that are measured over the full cycle of care, not just an individual care episode (JAMA 2007;297:1103–11).

“Physicians focused on value for patients will no longer see themselves as self-contained, isolated actors,” the authors wrote. “Instead, they will build stronger professional connections with complementary specialists who contribute to patient care across the care cycles for their patients.”

The authors pointed out that they do not advocate a single-payer system. They say instead that competition is healthy but the current system supports the wrong kind of competition.

It rewards physicians and health plans for taking patients away from one another or for shifting costs onto a competitor, rather than for providing value for the patient in the form of improved clinical outcomes, the authors said.

Their model is similar to the medical home concept that's being promoted by the American College of Physicians and the American Academy of Family Physicians. Under the concept, physicians would provide a bundled payment to a physician to coordinate care and there would be a pay-for-performance element based on patient outcomes.

Medicare will pay for a 3-year, eight-state demonstration of the medical home, and ACP and AAFP are working with IBM on testing such a program with its employees in Austin, Tex.

Physicians are in the best position to change the delivery of health care, Mr. Porter and Ms. Teisberg said. They could lead by becoming part of a care team and agreeing to accept a piece of a payment that would be bundled for the episode of care, not for an individual service. And they can take the lead in defining outcomes measurements, Mr. Porter said at the briefing.

In the article, the authors said that pay-for-performance models are also going down the wrong track, because they are aimed only at getting physicians to comply with processes of care. That will not provide value to the patient and will likely lead to micromanagement of medical practice, they said.

A study published the same week in the New England Journal of Medicine found that pay-for-performance proposals under Medicare aren't likely to work well under the current system, because patients' care is not being coordinated by a single provider. In fact, beneficiaries are seeing multiple physicians—typically seven physicians in four practices in a given year—which “impedes the ability of any one assigned provider to influence the overall quality of care for a given patient,” wrote the investigators, who were with the Center for Studying Health System Change and Memorial Sloan-Kettering Cancer Center (N. Engl. J. Med. 2007;356:1130–9).

Mr. Porter and Ms. Teisberg envision a future where care is delivered efficiently by physicians allied in partnerships or working for large group practices or staff-model managed care organizations.

Several large employers and employer coalitions are finding that it may be a worthwhile gamble to reduce or eliminate copayments for medications that control diabetes or treat comorbid conditions.

Pitney Bowes, for instance, reduced copays for diabetes drugs, as well as for asthma drugs, in 2001. The company realized first-year savings of about $1 million, according to an article published online in Health Affairs.

Diabetes is a fat target. Some 20 million Americans have the condition, leading to $132 billion in medical costs, disability, and lost productivity, according to the University of Michigan, one of the employers that recently launched a reduced-copay program. However, only about half of diabetes patients stick to their prescribed medication regimens, which can include as many as a dozen therapies. Out-of-pocket costs for those medications add up, which may deter patients from adhering to their treatment plans, according to the university.

These reduced copay programs are in stark contrast to a trend toward shifting costs onto workers. Copays for pharmaceuticals in particular have grown in the last decade. Making consumers shoulder more of the cost has helped bring down prescription drug spending from double-digit growth rates.

But higher copays can backfire. “When cost sharing is too large in relation to a consumer's resources, the result is either serious financial strain or reduced access to care,” according to an analysis issued by the Center for Studying Health System Change. The authors also found that these benefit structures “do not distinguish between services that are considered extremely important, such as testing, insulin, and physician visits to manage diabetes, and services that are more elective, such as knee surgery to play recreational sports.”

It seems counterproductive to erect hurdles that might prevent patients from accessing proven effective therapies for diabetes, Dr. William Herman said in an interview. Dr. Herman is medical director of M-Care, an HMO participating in the University of Michigan's 2-year pilot program for employees that aims to determine if reducing the cost of diabetes drugs will encourage more patients to stick to their treatment regimens and also cut overall health costs.

“If these copayments are interfering with desired processes of care and adversely affecting health outcomes, then this is not something we want in our benefit design,” Dr. Herman said.

Employees began enrolling in the Michigan program in July 2006. If they already were receiving an oral antidiabetic agent or insulin, they were automatically signed up. About 2,100 of those covered by university health plans are participating, out of a total worker and dependent population of 60,000, he said.

Under the program, enrollees pay nothing for generics (compared with $7 normally), $7 for preferred brands (instead of $14), and $18 for nonpreferred brands (instead of $24). These copays also apply to other drugs taken by diabetes patients, including β-blockers, calcium channel blockers, lipid-lowering agents, antihypertensives, and antidepressants.

University workers belong to a variety of health plans, but they all receive their prescriptions through a single pharmacy benefit manager, allowing for easier tracking of medication uptake and compliance, Dr. Herman said. Through its HMO, the university also will be able to compare medication compliance and health outcomes between diabetic workers and diabetes patients who aren't employees, he said.

So far, the program is costing the university about $30,000 a month, Dr. Herman said. That's how much patients are not spending.

There are no data yet on changes in hemoglobin A_1c levels, lipid levels, or medication uptake. If there are positive changes, the university is likely to stick with the reduced and waived copays, he said. The school also has looked at making similar reductions for other chronic diseases.

The Michigan program is unique in that patients do not have to enroll in a disease management program. Other employers have coupled reduced or waived copays with coaching from pharmacists.

That model was pioneered by employers in Asheville, N.C., and the North Carolina Center for Pharmaceutical Care. The program began in 1997 with 47 employer-participants. By 2003, those employers were reporting improved HbA_1c levels, a 50% reduction in average annual sick leave, and overall medical costs 58% below the expected level (J. Am. Pharm. Assoc. Wash. 2003;43:173–84). Employers saved $1,600–$3,300 per worker because of fewer emergency department visits and fewer diabetes-related hospitalizations, according to the American Pharmacists Association Foundation.

Soon after those results were published, the APhA Foundation, with financial backing from GlaxoSmithKline, created an initiative patterned after the Asheville Project. Thirty employers in 10 cities are now participating. It is a voluntary program, but once in, patients have to agree to meet with an assigned pharmacist—about 4–7 times yearly—for education and training, and to show they are working toward certain goals such as getting annual eye and foot exams, Bill Ellis, executive director and CEO of the APhA Foundation, said in an interview. In return, the cost of diabetes medication is reduced or eliminated, he said. On average, patients save $400 a year. Although employers are in many cases contributing a significant amount of money up front, they are willing to, Mr. Ellis said.

“They're making an investment in keeping people well,” he said.

The employers and the APhA Foundation are tracking clinical and economic outcomes and will eventually report those, along with patient satisfaction scores.

Several large employers and employer coalitions are finding that it may be a worthwhile gamble to reduce or eliminate copayments for medications that control diabetes or treat comorbid conditions.

Pitney Bowes, for instance, reduced copays for diabetes drugs, as well as for asthma drugs, in 2001. The company realized first-year savings of about $1 million, according to an article published online in Health Affairs.

Diabetes is a fat target. Some 20 million Americans have the condition, leading to $132 billion in medical costs, disability, and lost productivity, according to the University of Michigan, one of the employers that recently launched a reduced-copay program. However, only about half of diabetes patients stick to their prescribed medication regimens, which can include as many as a dozen therapies. Out-of-pocket costs for those medications add up, which may deter patients from adhering to their treatment plans, according to the university.

These reduced copay programs are in stark contrast to a trend toward shifting costs onto workers. Copays for pharmaceuticals in particular have grown in the last decade. Making consumers shoulder more of the cost has helped bring down prescription drug spending from double-digit growth rates.

But higher copays can backfire. “When cost sharing is too large in relation to a consumer's resources, the result is either serious financial strain or reduced access to care,” according to an analysis issued by the Center for Studying Health System Change. The authors also found that these benefit structures “do not distinguish between services that are considered extremely important, such as testing, insulin, and physician visits to manage diabetes, and services that are more elective, such as knee surgery to play recreational sports.”

It seems counterproductive to erect hurdles that might prevent patients from accessing proven effective therapies for diabetes, Dr. William Herman said in an interview. Dr. Herman is medical director of M-Care, an HMO participating in the University of Michigan's 2-year pilot program for employees that aims to determine if reducing the cost of diabetes drugs will encourage more patients to stick to their treatment regimens and also cut overall health costs.

“If these copayments are interfering with desired processes of care and adversely affecting health outcomes, then this is not something we want in our benefit design,” Dr. Herman said.

Employees began enrolling in the Michigan program in July 2006. If they already were receiving an oral antidiabetic agent or insulin, they were automatically signed up. About 2,100 of those covered by university health plans are participating, out of a total worker and dependent population of 60,000, he said.

Under the program, enrollees pay nothing for generics (compared with $7 normally), $7 for preferred brands (instead of $14), and $18 for nonpreferred brands (instead of $24). These copays also apply to other drugs taken by diabetes patients, including β-blockers, calcium channel blockers, lipid-lowering agents, antihypertensives, and antidepressants.

University workers belong to a variety of health plans, but they all receive their prescriptions through a single pharmacy benefit manager, allowing for easier tracking of medication uptake and compliance, Dr. Herman said. Through its HMO, the university also will be able to compare medication compliance and health outcomes between diabetic workers and diabetes patients who aren't employees, he said.

So far, the program is costing the university about $30,000 a month, Dr. Herman said. That's how much patients are not spending.

There are no data yet on changes in hemoglobin A_1c levels, lipid levels, or medication uptake. If there are positive changes, the university is likely to stick with the reduced and waived copays, he said. The school also has looked at making similar reductions for other chronic diseases.

The Michigan program is unique in that patients do not have to enroll in a disease management program. Other employers have coupled reduced or waived copays with coaching from pharmacists.

That model was pioneered by employers in Asheville, N.C., and the North Carolina Center for Pharmaceutical Care. The program began in 1997 with 47 employer-participants. By 2003, those employers were reporting improved HbA_1c levels, a 50% reduction in average annual sick leave, and overall medical costs 58% below the expected level (J. Am. Pharm. Assoc. Wash. 2003;43:173–84). Employers saved $1,600–$3,300 per worker because of fewer emergency department visits and fewer diabetes-related hospitalizations, according to the American Pharmacists Association Foundation.

Soon after those results were published, the APhA Foundation, with financial backing from GlaxoSmithKline, created an initiative patterned after the Asheville Project. Thirty employers in 10 cities are now participating. It is a voluntary program, but once in, patients have to agree to meet with an assigned pharmacist—about 4–7 times yearly—for education and training, and to show they are working toward certain goals such as getting annual eye and foot exams, Bill Ellis, executive director and CEO of the APhA Foundation, said in an interview. In return, the cost of diabetes medication is reduced or eliminated, he said. On average, patients save $400 a year. Although employers are in many cases contributing a significant amount of money up front, they are willing to, Mr. Ellis said.

“They're making an investment in keeping people well,” he said.

The employers and the APhA Foundation are tracking clinical and economic outcomes and will eventually report those, along with patient satisfaction scores.

Several large employers and employer coalitions are finding that it may be a worthwhile gamble to reduce or eliminate copayments for medications that control diabetes or treat comorbid conditions.

Pitney Bowes, for instance, reduced copays for diabetes drugs, as well as for asthma drugs, in 2001. The company realized first-year savings of about $1 million, according to an article published online in Health Affairs.

Diabetes is a fat target. Some 20 million Americans have the condition, leading to $132 billion in medical costs, disability, and lost productivity, according to the University of Michigan, one of the employers that recently launched a reduced-copay program. However, only about half of diabetes patients stick to their prescribed medication regimens, which can include as many as a dozen therapies. Out-of-pocket costs for those medications add up, which may deter patients from adhering to their treatment plans, according to the university.

These reduced copay programs are in stark contrast to a trend toward shifting costs onto workers. Copays for pharmaceuticals in particular have grown in the last decade. Making consumers shoulder more of the cost has helped bring down prescription drug spending from double-digit growth rates.

But higher copays can backfire. “When cost sharing is too large in relation to a consumer's resources, the result is either serious financial strain or reduced access to care,” according to an analysis issued by the Center for Studying Health System Change. The authors also found that these benefit structures “do not distinguish between services that are considered extremely important, such as testing, insulin, and physician visits to manage diabetes, and services that are more elective, such as knee surgery to play recreational sports.”

It seems counterproductive to erect hurdles that might prevent patients from accessing proven effective therapies for diabetes, Dr. William Herman said in an interview. Dr. Herman is medical director of M-Care, an HMO participating in the University of Michigan's 2-year pilot program for employees that aims to determine if reducing the cost of diabetes drugs will encourage more patients to stick to their treatment regimens and also cut overall health costs.

“If these copayments are interfering with desired processes of care and adversely affecting health outcomes, then this is not something we want in our benefit design,” Dr. Herman said.

Employees began enrolling in the Michigan program in July 2006. If they already were receiving an oral antidiabetic agent or insulin, they were automatically signed up. About 2,100 of those covered by university health plans are participating, out of a total worker and dependent population of 60,000, he said.

Under the program, enrollees pay nothing for generics (compared with $7 normally), $7 for preferred brands (instead of $14), and $18 for nonpreferred brands (instead of $24). These copays also apply to other drugs taken by diabetes patients, including β-blockers, calcium channel blockers, lipid-lowering agents, antihypertensives, and antidepressants.

University workers belong to a variety of health plans, but they all receive their prescriptions through a single pharmacy benefit manager, allowing for easier tracking of medication uptake and compliance, Dr. Herman said. Through its HMO, the university also will be able to compare medication compliance and health outcomes between diabetic workers and diabetes patients who aren't employees, he said.

So far, the program is costing the university about $30,000 a month, Dr. Herman said. That's how much patients are not spending.

There are no data yet on changes in hemoglobin A_1c levels, lipid levels, or medication uptake. If there are positive changes, the university is likely to stick with the reduced and waived copays, he said. The school also has looked at making similar reductions for other chronic diseases.

The Michigan program is unique in that patients do not have to enroll in a disease management program. Other employers have coupled reduced or waived copays with coaching from pharmacists.

That model was pioneered by employers in Asheville, N.C., and the North Carolina Center for Pharmaceutical Care. The program began in 1997 with 47 employer-participants. By 2003, those employers were reporting improved HbA_1c levels, a 50% reduction in average annual sick leave, and overall medical costs 58% below the expected level (J. Am. Pharm. Assoc. Wash. 2003;43:173–84). Employers saved $1,600–$3,300 per worker because of fewer emergency department visits and fewer diabetes-related hospitalizations, according to the American Pharmacists Association Foundation.

Soon after those results were published, the APhA Foundation, with financial backing from GlaxoSmithKline, created an initiative patterned after the Asheville Project. Thirty employers in 10 cities are now participating. It is a voluntary program, but once in, patients have to agree to meet with an assigned pharmacist—about 4–7 times yearly—for education and training, and to show they are working toward certain goals such as getting annual eye and foot exams, Bill Ellis, executive director and CEO of the APhA Foundation, said in an interview. In return, the cost of diabetes medication is reduced or eliminated, he said. On average, patients save $400 a year. Although employers are in many cases contributing a significant amount of money up front, they are willing to, Mr. Ellis said.

“They're making an investment in keeping people well,” he said.

The employers and the APhA Foundation are tracking clinical and economic outcomes and will eventually report those, along with patient satisfaction scores.

The Food and Drug Administration has issued a final rule that would require medical glove makers to improve their products' ability to serve as a barrier against pathogens.

Manufacturers are being given 2 years to comply with the new regulations.

The goal is to reduce the risk of transmission of bloodborne pathogens such as HIV and hepatitis B, according to the FDA. The agency estimated that approximately 2.4 HIV infections occur each year due to “problems with the barrier protection properties” of medical gloves.

The FDA estimates that 140 health care workers are infected with the hepatitis B virus (HBV) on the job each year. About a third, or 40 cases, may be due to glove defects, according to the agency.

There is less evidence that glove defects are associated with hepatitis C, said the agency, noting that most occupational exposures are from needle sticks.

The agency has inspected gloves—used for patient examinations and surgical procedures—since 1990. At that time, the International Organization for Standardization (ISO), ASTM International, and the FDA had the same standards for glove quality. A few years later, the ISO and ASTM began requiring higher standards.

The FDA has allowed a defect rate of 4% for gloves used during patient exams and 2.5% for gloves used in surgery.

With more and more brands of gloves being marketed and sold, the agency hopes to maintain that defect rate. To do so means increasing the quality standards, said the agency.

The Food and Drug Administration has issued a final rule that would require medical glove makers to improve their products' ability to serve as a barrier against pathogens.

Manufacturers are being given 2 years to comply with the new regulations.

The goal is to reduce the risk of transmission of bloodborne pathogens such as HIV and hepatitis B, according to the FDA. The agency estimated that approximately 2.4 HIV infections occur each year due to “problems with the barrier protection properties” of medical gloves.

The FDA estimates that 140 health care workers are infected with the hepatitis B virus (HBV) on the job each year. About a third, or 40 cases, may be due to glove defects, according to the agency.

There is less evidence that glove defects are associated with hepatitis C, said the agency, noting that most occupational exposures are from needle sticks.

The agency has inspected gloves—used for patient examinations and surgical procedures—since 1990. At that time, the International Organization for Standardization (ISO), ASTM International, and the FDA had the same standards for glove quality. A few years later, the ISO and ASTM began requiring higher standards.

The FDA has allowed a defect rate of 4% for gloves used during patient exams and 2.5% for gloves used in surgery.

With more and more brands of gloves being marketed and sold, the agency hopes to maintain that defect rate. To do so means increasing the quality standards, said the agency.

The Food and Drug Administration has issued a final rule that would require medical glove makers to improve their products' ability to serve as a barrier against pathogens.

Manufacturers are being given 2 years to comply with the new regulations.

The goal is to reduce the risk of transmission of bloodborne pathogens such as HIV and hepatitis B, according to the FDA. The agency estimated that approximately 2.4 HIV infections occur each year due to “problems with the barrier protection properties” of medical gloves.

The FDA estimates that 140 health care workers are infected with the hepatitis B virus (HBV) on the job each year. About a third, or 40 cases, may be due to glove defects, according to the agency.

There is less evidence that glove defects are associated with hepatitis C, said the agency, noting that most occupational exposures are from needle sticks.

The agency has inspected gloves—used for patient examinations and surgical procedures—since 1990. At that time, the International Organization for Standardization (ISO), ASTM International, and the FDA had the same standards for glove quality. A few years later, the ISO and ASTM began requiring higher standards.

The FDA has allowed a defect rate of 4% for gloves used during patient exams and 2.5% for gloves used in surgery.

With more and more brands of gloves being marketed and sold, the agency hopes to maintain that defect rate. To do so means increasing the quality standards, said the agency.

The Food and Drug Administration is proposing to beef up its conflict-of-interest guidelines for experts who serve on its advisory committees, the agency announced in a teleconference.

Proposed guidelines would bar experts with stock or other financial interests worth more than $50,000 in a particular company from reviewing that manufacturer's product, and ban voting by those who receive or own less than $50,000.

The $50,000 rule would be applied to any holdings or interest within 12 months of an advisory panel meeting.

The proposal was billed by FDA officials as an upgrade of guidelines that have been in effect since 2000 and were made partly in response to public demands for more accountability, according to Randall Lutter, FDA acting deputy commissioner for policy.

“[The] FDA is committed to making the advisory committee process more rigorous and transparent so that the public has confidence in the integrity of the recommendations made by its advisory committees,” said Mr. Lutter in a statement issued by the agency.

However, in the briefing, he said the FDA “was not aware of any instances where decision making has been adversely affected by conflicts members might have.”

The new guidance attempts to balance the quest for transparency with the need for qualified experts, said Mr. Lutter.

As in the past, the guidelines are not legally binding. They are offered as suggestions to staff evaluating potential conflicts of interest by both government and nongovernment employees. It is rare for staff to make decisions that fall outside of the guidance, though, and waivers will likely only rarely be granted, said Mr. Lutter.

For instance, if a panel member has received an individual grant or other fee of less than $50,000 from a company for work in the hematology area, but is reviewing the company's cardiology drug or device, that person might be allowed to participate in the panel meeting.

The guidance document was posted on the FDA's Web site on March 21.

The Food and Drug Administration is proposing to beef up its conflict-of-interest guidelines for experts who serve on its advisory committees, the agency announced in a teleconference.

Proposed guidelines would bar experts with stock or other financial interests worth more than $50,000 in a particular company from reviewing that manufacturer's product, and ban voting by those who receive or own less than $50,000.

The $50,000 rule would be applied to any holdings or interest within 12 months of an advisory panel meeting.

The proposal was billed by FDA officials as an upgrade of guidelines that have been in effect since 2000 and were made partly in response to public demands for more accountability, according to Randall Lutter, FDA acting deputy commissioner for policy.

“[The] FDA is committed to making the advisory committee process more rigorous and transparent so that the public has confidence in the integrity of the recommendations made by its advisory committees,” said Mr. Lutter in a statement issued by the agency.

However, in the briefing, he said the FDA “was not aware of any instances where decision making has been adversely affected by conflicts members might have.”

The new guidance attempts to balance the quest for transparency with the need for qualified experts, said Mr. Lutter.

As in the past, the guidelines are not legally binding. They are offered as suggestions to staff evaluating potential conflicts of interest by both government and nongovernment employees. It is rare for staff to make decisions that fall outside of the guidance, though, and waivers will likely only rarely be granted, said Mr. Lutter.

For instance, if a panel member has received an individual grant or other fee of less than $50,000 from a company for work in the hematology area, but is reviewing the company's cardiology drug or device, that person might be allowed to participate in the panel meeting.

The guidance document was posted on the FDA's Web site on March 21.

The Food and Drug Administration is proposing to beef up its conflict-of-interest guidelines for experts who serve on its advisory committees, the agency announced in a teleconference.

Proposed guidelines would bar experts with stock or other financial interests worth more than $50,000 in a particular company from reviewing that manufacturer's product, and ban voting by those who receive or own less than $50,000.

The $50,000 rule would be applied to any holdings or interest within 12 months of an advisory panel meeting.

The proposal was billed by FDA officials as an upgrade of guidelines that have been in effect since 2000 and were made partly in response to public demands for more accountability, according to Randall Lutter, FDA acting deputy commissioner for policy.

“[The] FDA is committed to making the advisory committee process more rigorous and transparent so that the public has confidence in the integrity of the recommendations made by its advisory committees,” said Mr. Lutter in a statement issued by the agency.

However, in the briefing, he said the FDA “was not aware of any instances where decision making has been adversely affected by conflicts members might have.”

The new guidance attempts to balance the quest for transparency with the need for qualified experts, said Mr. Lutter.

As in the past, the guidelines are not legally binding. They are offered as suggestions to staff evaluating potential conflicts of interest by both government and nongovernment employees. It is rare for staff to make decisions that fall outside of the guidance, though, and waivers will likely only rarely be granted, said Mr. Lutter.

For instance, if a panel member has received an individual grant or other fee of less than $50,000 from a company for work in the hematology area, but is reviewing the company's cardiology drug or device, that person might be allowed to participate in the panel meeting.

The guidance document was posted on the FDA's Web site on March 21.

WASHINGTON — The U.S. health care delivery system should be overhauled to organize medical practice around “integrated care cycles” that are coordinated by a central physician and to reward physicians for providing value, Michael E. Porter said at a media briefing presented by the Journal of the American Medical Association.

The proposals are a shortened version of a book written by Mr. Porter, the Bishop William Lawrence University Professor at Harvard Business School, and his coauthor, Elizabeth Olmsted Teisberg of the University of Virginia's Darden Graduate School of Business.

According to Mr. Porter and Ms. Teisberg, a value-based system has three principles: providing value for patients, organizing delivery of care around conditions and care cycles, and measuring results, preferably risk-adjusted outcomes that are measured over the full cycle of care, not just an individual care episode (JAMA 2007;297:1103–11).

“Physicians focused on value for patients will no longer see themselves as self-contained, isolated actors,” the authors wrote. “Instead, they will build stronger professional connections with complementary specialists who contribute to patient care across the care cycles for their patients.”

The authors pointed out that they do not advocate a single-payer system. They say instead that competition is healthy but the current system supports the wrong kind of competition.

It rewards physicians and health plans for taking patients away from one another or for shifting costs onto a competitor, rather than for providing value for the patient in the form of improved clinical outcomes, said the authors.

Physicians are in the best position to change the delivery of health care, they said. “Physicians have to get out of the bunker,” Mr. Porter said at the briefing.

He said they could lead by becoming part of a care team and agreeing to accept a piece of a payment that would be bundled for the episode of care, not for an individual service. And they can take the lead in defining outcomes measurements, Mr. Porter said.

In the article, the authors said that pay-for-performance models are also going down the wrong track, because they are aimed only at getting physicians to comply with processes of care. That will not provide value to the patient and will likely lead to micromanagement of medical practice, they said.

A study published the same week in March in the New England Journal of Medicine found that pay-for-performance proposals under Medicare aren't likely to work well under the current system, because patients' care is not being coordinated by a single provider. In fact, beneficiaries are seeing multiple physicians—typically seven physicians in four practices in a given year—which “impedes the ability of any one assigned provider to influence the overall quality of care for a given patient,” wrote the investigators, who were with the Center for Studying Health System Change and the Memorial Sloan-Kettering Cancer Center's Health Outcomes Research Group (N. Engl. J. Med. 2007;356:1130–9).

Mr. Porter and Ms. Teisberg envision a future where most physicians are allied in partnerships or working for large group practices or staff-model managed care organizations, so that the care can be delivered more efficiently.

Their model is similar to the medical home concept that's being promoted by the American College of Physicians and the American Academy of Family Physicians. Under the concept, physicians would provide a bundled payment to a physician to coordinate care and there would be a pay-for-performance element based on patient outcomes.

Medicare will pay for a 3-year, eight-state demonstration of the medical home, and ACP and AAFP are working with IBM on testing such a program with its employees in Austin, Tex.

WASHINGTON — The U.S. health care delivery system should be overhauled to organize medical practice around “integrated care cycles” that are coordinated by a central physician and to reward physicians for providing value, Michael E. Porter said at a media briefing presented by the Journal of the American Medical Association.

The proposals are a shortened version of a book written by Mr. Porter, the Bishop William Lawrence University Professor at Harvard Business School, and his coauthor, Elizabeth Olmsted Teisberg of the University of Virginia's Darden Graduate School of Business.

According to Mr. Porter and Ms. Teisberg, a value-based system has three principles: providing value for patients, organizing delivery of care around conditions and care cycles, and measuring results, preferably risk-adjusted outcomes that are measured over the full cycle of care, not just an individual care episode (JAMA 2007;297:1103–11).

“Physicians focused on value for patients will no longer see themselves as self-contained, isolated actors,” the authors wrote. “Instead, they will build stronger professional connections with complementary specialists who contribute to patient care across the care cycles for their patients.”

The authors pointed out that they do not advocate a single-payer system. They say instead that competition is healthy but the current system supports the wrong kind of competition.

It rewards physicians and health plans for taking patients away from one another or for shifting costs onto a competitor, rather than for providing value for the patient in the form of improved clinical outcomes, said the authors.

Physicians are in the best position to change the delivery of health care, they said. “Physicians have to get out of the bunker,” Mr. Porter said at the briefing.

He said they could lead by becoming part of a care team and agreeing to accept a piece of a payment that would be bundled for the episode of care, not for an individual service. And they can take the lead in defining outcomes measurements, Mr. Porter said.

In the article, the authors said that pay-for-performance models are also going down the wrong track, because they are aimed only at getting physicians to comply with processes of care. That will not provide value to the patient and will likely lead to micromanagement of medical practice, they said.

A study published the same week in March in the New England Journal of Medicine found that pay-for-performance proposals under Medicare aren't likely to work well under the current system, because patients' care is not being coordinated by a single provider. In fact, beneficiaries are seeing multiple physicians—typically seven physicians in four practices in a given year—which “impedes the ability of any one assigned provider to influence the overall quality of care for a given patient,” wrote the investigators, who were with the Center for Studying Health System Change and the Memorial Sloan-Kettering Cancer Center's Health Outcomes Research Group (N. Engl. J. Med. 2007;356:1130–9).

Mr. Porter and Ms. Teisberg envision a future where most physicians are allied in partnerships or working for large group practices or staff-model managed care organizations, so that the care can be delivered more efficiently.

Their model is similar to the medical home concept that's being promoted by the American College of Physicians and the American Academy of Family Physicians. Under the concept, physicians would provide a bundled payment to a physician to coordinate care and there would be a pay-for-performance element based on patient outcomes.

Medicare will pay for a 3-year, eight-state demonstration of the medical home, and ACP and AAFP are working with IBM on testing such a program with its employees in Austin, Tex.

WASHINGTON — The U.S. health care delivery system should be overhauled to organize medical practice around “integrated care cycles” that are coordinated by a central physician and to reward physicians for providing value, Michael E. Porter said at a media briefing presented by the Journal of the American Medical Association.

The proposals are a shortened version of a book written by Mr. Porter, the Bishop William Lawrence University Professor at Harvard Business School, and his coauthor, Elizabeth Olmsted Teisberg of the University of Virginia's Darden Graduate School of Business.

According to Mr. Porter and Ms. Teisberg, a value-based system has three principles: providing value for patients, organizing delivery of care around conditions and care cycles, and measuring results, preferably risk-adjusted outcomes that are measured over the full cycle of care, not just an individual care episode (JAMA 2007;297:1103–11).

“Physicians focused on value for patients will no longer see themselves as self-contained, isolated actors,” the authors wrote. “Instead, they will build stronger professional connections with complementary specialists who contribute to patient care across the care cycles for their patients.”

The authors pointed out that they do not advocate a single-payer system. They say instead that competition is healthy but the current system supports the wrong kind of competition.

It rewards physicians and health plans for taking patients away from one another or for shifting costs onto a competitor, rather than for providing value for the patient in the form of improved clinical outcomes, said the authors.

Physicians are in the best position to change the delivery of health care, they said. “Physicians have to get out of the bunker,” Mr. Porter said at the briefing.

He said they could lead by becoming part of a care team and agreeing to accept a piece of a payment that would be bundled for the episode of care, not for an individual service. And they can take the lead in defining outcomes measurements, Mr. Porter said.

In the article, the authors said that pay-for-performance models are also going down the wrong track, because they are aimed only at getting physicians to comply with processes of care. That will not provide value to the patient and will likely lead to micromanagement of medical practice, they said.

A study published the same week in March in the New England Journal of Medicine found that pay-for-performance proposals under Medicare aren't likely to work well under the current system, because patients' care is not being coordinated by a single provider. In fact, beneficiaries are seeing multiple physicians—typically seven physicians in four practices in a given year—which “impedes the ability of any one assigned provider to influence the overall quality of care for a given patient,” wrote the investigators, who were with the Center for Studying Health System Change and the Memorial Sloan-Kettering Cancer Center's Health Outcomes Research Group (N. Engl. J. Med. 2007;356:1130–9).

Mr. Porter and Ms. Teisberg envision a future where most physicians are allied in partnerships or working for large group practices or staff-model managed care organizations, so that the care can be delivered more efficiently.

Their model is similar to the medical home concept that's being promoted by the American College of Physicians and the American Academy of Family Physicians. Under the concept, physicians would provide a bundled payment to a physician to coordinate care and there would be a pay-for-performance element based on patient outcomes.

Medicare will pay for a 3-year, eight-state demonstration of the medical home, and ACP and AAFP are working with IBM on testing such a program with its employees in Austin, Tex.

WASHINGTON — Food and Drug Administration officials said in March that they have started several new initiatives in response to the Institute of Medicine's call to upgrade and overhaul its drug safety efforts. The projects, including a pilot project to more closely monitor the postmarketing safety of four new molecular entities and a plan to put more postmarketing data on the agency's Web site, were revealed at a meeting sponsored by the IOM.

In a September 2006 report that lambasted FDA's safety oversight, the IOM called on the agency to issue an interim report on selected drugs' postmarketing safety at least 18 months, and no longer than 5 years, after launch.

“I think 5 years is too late to find out what a drug is doing,” said Dr. Robert Temple, associate director for medical policy at the FDA.

The FDA's Center for Drug Evaluation and Research (CDER) has begun a pilot project with four new molecular entities to pull together all available data at 1, 2, and 3 years after launch. Officials will look at the Adverse Events Reporting System database, ongoing postmarketing studies, and other data to see how much can be learned about each particular drug at each time point, said Dr. Temple. He would not disclose which drugs are part of the pilot.

The FDA also plans to publish a newsletter on its Web site that will provide up-to-date information on a drug's postmarketing experience, said Dr. Ellis Unger, acting deputy director for science at CDER's Office of Surveillance and Epidemiology. He promised a full accounting but noted that the agency will not disclose any proprietary information.

The IOM report also urged Congress to give the FDA greater and more precise enforcement powers, partly to compel pharmaceutical manufacturers to fulfill their commitments to gather postmarketing data.

Peter Barton Hutt, a former FDA general counsel and now senior counsel with Covington and Burling in Washington said that most companies comply with FDA requests because “industry is terrified of FDA.” Mr. Hutt said FDA had all the enforcement power it needed already. He argued that the agency did, however, need more funding outside of the user fees it collects.

FDA critics have said the agency is unduly beholden to industry because of user fees. Former FDA Deputy Commissioner Mary Pendergast noted that those fees were likely to make up 80% of the agency's drug review and safety budget if Congress did not provide additional money for fiscal 2007.

She also noted that as of fiscal 2006, companies had 1,632 pending postmarketing commitments. The number of studies being requested is on the rise, said Ms. Pendergast, noting that the average was 1.5 per approved drug before 2003 and 5 per approved drug in 2003–2004. In the most recent report to Congress (fiscal 2006), 63% of those studies had not been started, she said. The agency needs a better hammer to get those studies done, said Ms. Pendergast.

WASHINGTON — Food and Drug Administration officials said in March that they have started several new initiatives in response to the Institute of Medicine's call to upgrade and overhaul its drug safety efforts. The projects, including a pilot project to more closely monitor the postmarketing safety of four new molecular entities and a plan to put more postmarketing data on the agency's Web site, were revealed at a meeting sponsored by the IOM.

In a September 2006 report that lambasted FDA's safety oversight, the IOM called on the agency to issue an interim report on selected drugs' postmarketing safety at least 18 months, and no longer than 5 years, after launch.

“I think 5 years is too late to find out what a drug is doing,” said Dr. Robert Temple, associate director for medical policy at the FDA.

The FDA's Center for Drug Evaluation and Research (CDER) has begun a pilot project with four new molecular entities to pull together all available data at 1, 2, and 3 years after launch. Officials will look at the Adverse Events Reporting System database, ongoing postmarketing studies, and other data to see how much can be learned about each particular drug at each time point, said Dr. Temple. He would not disclose which drugs are part of the pilot.

The FDA also plans to publish a newsletter on its Web site that will provide up-to-date information on a drug's postmarketing experience, said Dr. Ellis Unger, acting deputy director for science at CDER's Office of Surveillance and Epidemiology. He promised a full accounting but noted that the agency will not disclose any proprietary information.

The IOM report also urged Congress to give the FDA greater and more precise enforcement powers, partly to compel pharmaceutical manufacturers to fulfill their commitments to gather postmarketing data.

Peter Barton Hutt, a former FDA general counsel and now senior counsel with Covington and Burling in Washington said that most companies comply with FDA requests because “industry is terrified of FDA.” Mr. Hutt said FDA had all the enforcement power it needed already. He argued that the agency did, however, need more funding outside of the user fees it collects.

FDA critics have said the agency is unduly beholden to industry because of user fees. Former FDA Deputy Commissioner Mary Pendergast noted that those fees were likely to make up 80% of the agency's drug review and safety budget if Congress did not provide additional money for fiscal 2007.

She also noted that as of fiscal 2006, companies had 1,632 pending postmarketing commitments. The number of studies being requested is on the rise, said Ms. Pendergast, noting that the average was 1.5 per approved drug before 2003 and 5 per approved drug in 2003–2004. In the most recent report to Congress (fiscal 2006), 63% of those studies had not been started, she said. The agency needs a better hammer to get those studies done, said Ms. Pendergast.

WASHINGTON — Food and Drug Administration officials said in March that they have started several new initiatives in response to the Institute of Medicine's call to upgrade and overhaul its drug safety efforts. The projects, including a pilot project to more closely monitor the postmarketing safety of four new molecular entities and a plan to put more postmarketing data on the agency's Web site, were revealed at a meeting sponsored by the IOM.

In a September 2006 report that lambasted FDA's safety oversight, the IOM called on the agency to issue an interim report on selected drugs' postmarketing safety at least 18 months, and no longer than 5 years, after launch.

“I think 5 years is too late to find out what a drug is doing,” said Dr. Robert Temple, associate director for medical policy at the FDA.

The FDA's Center for Drug Evaluation and Research (CDER) has begun a pilot project with four new molecular entities to pull together all available data at 1, 2, and 3 years after launch. Officials will look at the Adverse Events Reporting System database, ongoing postmarketing studies, and other data to see how much can be learned about each particular drug at each time point, said Dr. Temple. He would not disclose which drugs are part of the pilot.

The FDA also plans to publish a newsletter on its Web site that will provide up-to-date information on a drug's postmarketing experience, said Dr. Ellis Unger, acting deputy director for science at CDER's Office of Surveillance and Epidemiology. He promised a full accounting but noted that the agency will not disclose any proprietary information.

The IOM report also urged Congress to give the FDA greater and more precise enforcement powers, partly to compel pharmaceutical manufacturers to fulfill their commitments to gather postmarketing data.

Peter Barton Hutt, a former FDA general counsel and now senior counsel with Covington and Burling in Washington said that most companies comply with FDA requests because “industry is terrified of FDA.” Mr. Hutt said FDA had all the enforcement power it needed already. He argued that the agency did, however, need more funding outside of the user fees it collects.

FDA critics have said the agency is unduly beholden to industry because of user fees. Former FDA Deputy Commissioner Mary Pendergast noted that those fees were likely to make up 80% of the agency's drug review and safety budget if Congress did not provide additional money for fiscal 2007.

She also noted that as of fiscal 2006, companies had 1,632 pending postmarketing commitments. The number of studies being requested is on the rise, said Ms. Pendergast, noting that the average was 1.5 per approved drug before 2003 and 5 per approved drug in 2003–2004. In the most recent report to Congress (fiscal 2006), 63% of those studies had not been started, she said. The agency needs a better hammer to get those studies done, said Ms. Pendergast.

WASHINGTON — The first study of emergency Medicaid expenditures for illegal immigrants shows that childbirth is the most expensive component. However, at least in North Carolina, that expense was less than 1% of the state's Medicaid budget, showing that state and federal authorities are not pouring huge amounts of dollars into providing health care for undocumented immigrants, Dr. C. Annette DuBard, the study's lead author, said at a media briefing presented by the Journal of the American Medical Association.

With debate growing over whether states should pay for illegal immigrants' health care, Dr. DuBard, a research associate at the University of North Carolina, Chapel Hill, and Dr. Mark W. Massing of the Carolinas Center for Medical Excellence in Cary, N.C., set out to document the expenditures. They published their results in a special issue of JAMA devoted to access to care issues (JAMA 2007;297:1085–92).

North Carolina had a 274% increase in its foreign-born population in the 1990s, including about 300,000 undocumented immigrants by 2004, according to the authors.

Federal law excludes illegal immigrants from receiving Medicaid; even legal immigrants aren't eligible until they've been in the United States for 5 years. But undocumented immigrants who are children, pregnant, part of a family with dependent children, or elderly and disabled who meet income and residency requirements can get Medicaid coverage for emergency medical services.

From 2001 to 2004, 48,000 undocumented immigrants received emergency Medicaid services in North Carolina. Overall, spending rose from $41 million in 2001 to $53 million in 2004. About 90% of the patients were aged 18–40 years, 95% were female, and 90% were eligible because of pregnancy. Almost all (93%) were Hispanic. Childbirth and complications of pregnancy accounted for 86% of total expenditures in 2001, dropping to 82% in 2004. The dollar amount spent for children and pregnant women grew about 20% over the 4-year period.

Given that most children born to illegal immigrants are granted citizenship, it “calls into question the rationale of excluding this population from comprehensive contraceptive and prenatal care coverage,” Dr. DuBard and Dr. Massey wrote.

Eight states provide coverage for prenatal care under the State Children's Health Insurance Program and five other states cover prenatal care regardless of immigration status, according to the authors.

Spending on childbirth paled in comparison with North Carolina's expenditures on the disabled and the elderly, which increased 82% and 98%, respectively, since 2001.

WASHINGTON — The first study of emergency Medicaid expenditures for illegal immigrants shows that childbirth is the most expensive component. However, at least in North Carolina, that expense was less than 1% of the state's Medicaid budget, showing that state and federal authorities are not pouring huge amounts of dollars into providing health care for undocumented immigrants, Dr. C. Annette DuBard, the study's lead author, said at a media briefing presented by the Journal of the American Medical Association.

With debate growing over whether states should pay for illegal immigrants' health care, Dr. DuBard, a research associate at the University of North Carolina, Chapel Hill, and Dr. Mark W. Massing of the Carolinas Center for Medical Excellence in Cary, N.C., set out to document the expenditures. They published their results in a special issue of JAMA devoted to access to care issues (JAMA 2007;297:1085–92).

North Carolina had a 274% increase in its foreign-born population in the 1990s, including about 300,000 undocumented immigrants by 2004, according to the authors.

Federal law excludes illegal immigrants from receiving Medicaid; even legal immigrants aren't eligible until they've been in the United States for 5 years. But undocumented immigrants who are children, pregnant, part of a family with dependent children, or elderly and disabled who meet income and residency requirements can get Medicaid coverage for emergency medical services.

From 2001 to 2004, 48,000 undocumented immigrants received emergency Medicaid services in North Carolina. Overall, spending rose from $41 million in 2001 to $53 million in 2004. About 90% of the patients were aged 18–40 years, 95% were female, and 90% were eligible because of pregnancy. Almost all (93%) were Hispanic. Childbirth and complications of pregnancy accounted for 86% of total expenditures in 2001, dropping to 82% in 2004. The dollar amount spent for children and pregnant women grew about 20% over the 4-year period.

Given that most children born to illegal immigrants are granted citizenship, it “calls into question the rationale of excluding this population from comprehensive contraceptive and prenatal care coverage,” Dr. DuBard and Dr. Massey wrote.

Eight states provide coverage for prenatal care under the State Children's Health Insurance Program and five other states cover prenatal care regardless of immigration status, according to the authors.

Spending on childbirth paled in comparison with North Carolina's expenditures on the disabled and the elderly, which increased 82% and 98%, respectively, since 2001.

WASHINGTON — The first study of emergency Medicaid expenditures for illegal immigrants shows that childbirth is the most expensive component. However, at least in North Carolina, that expense was less than 1% of the state's Medicaid budget, showing that state and federal authorities are not pouring huge amounts of dollars into providing health care for undocumented immigrants, Dr. C. Annette DuBard, the study's lead author, said at a media briefing presented by the Journal of the American Medical Association.

With debate growing over whether states should pay for illegal immigrants' health care, Dr. DuBard, a research associate at the University of North Carolina, Chapel Hill, and Dr. Mark W. Massing of the Carolinas Center for Medical Excellence in Cary, N.C., set out to document the expenditures. They published their results in a special issue of JAMA devoted to access to care issues (JAMA 2007;297:1085–92).

North Carolina had a 274% increase in its foreign-born population in the 1990s, including about 300,000 undocumented immigrants by 2004, according to the authors.

Federal law excludes illegal immigrants from receiving Medicaid; even legal immigrants aren't eligible until they've been in the United States for 5 years. But undocumented immigrants who are children, pregnant, part of a family with dependent children, or elderly and disabled who meet income and residency requirements can get Medicaid coverage for emergency medical services.

From 2001 to 2004, 48,000 undocumented immigrants received emergency Medicaid services in North Carolina. Overall, spending rose from $41 million in 2001 to $53 million in 2004. About 90% of the patients were aged 18–40 years, 95% were female, and 90% were eligible because of pregnancy. Almost all (93%) were Hispanic. Childbirth and complications of pregnancy accounted for 86% of total expenditures in 2001, dropping to 82% in 2004. The dollar amount spent for children and pregnant women grew about 20% over the 4-year period.

Given that most children born to illegal immigrants are granted citizenship, it “calls into question the rationale of excluding this population from comprehensive contraceptive and prenatal care coverage,” Dr. DuBard and Dr. Massey wrote.

Eight states provide coverage for prenatal care under the State Children's Health Insurance Program and five other states cover prenatal care regardless of immigration status, according to the authors.

Spending on childbirth paled in comparison with North Carolina's expenditures on the disabled and the elderly, which increased 82% and 98%, respectively, since 2001.