Alicia Ault

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.

The American College of Cardiology's burgeoning stable of registries will likely include one to collect outpatient data by late this year or early next year, according to the organization.

Ten years ago, the ACC launched the National Cardiovascular Data Registry (NCDR). It has subsequently launched the CathPCI Registry, the ICD Registry, and, just last year, the CARE (Carotid Artery Revascularization and Endarterectomy) Registry, all of which are centered on hospital-based procedures.

Clearly, outpatient data represent both a gap and an opportunity, Dr. Ralph Brindis, chief medical officer for the NCDR, said in an interview. “As we've developed an increasing portfolio, there's been a lot of interest among cardiologists and payers, and interest from the American Board of Internal Medicine, in how we can actually assess quality in the outpatient arena,” he continued.

Pharmaceutical manufacturers are also interested in outpatient registries to help assess long-term safety and efficacy of medications, he said.

The outpatient effort, tentatively dubbed IC3 (Improving Continuity in Cardiac Care), is in the beginning stages, with protocols, data collection tools, and reports being developed. After securing industry funding for the launch, the registry will be piloted at 100–150 physician offices across the United States next summer, Dr. Brindis said. Within a year, ACC hopes to have 400 offices enrolled and perhaps more than 1,000 in 2–3 years.

Initially, the focus will be on patients who are post discharge for acute coronary syndrome. Physicians will be asked to submit data on meeting performance goals related to prescribing evidence-based therapies such as aspirin, β-blockers, and ACE inhibitors, and how well patients and physicians do in meeting cholesterol goals.

Over time, measures will likely expand to meeting benchmarks for hypertension and heart failure treatment, and perhaps appropriateness of imaging studies, Dr. Brindis said. Eventually, the registry might be used to help physicians meet reporting needs and maintain certification through the ABIM, he said.

The registry would be voluntary. Dr. Brindis said there would be some effort to make it manageable for practices that aren't heavily invested in health information technology.

Also, Dr. Brindis said, the ACC might initially provide payments to the pilot participants, but, he added, “In the long run, hopefully, there would be so much added value that we wouldn't pay them to participate.”

The American College of Cardiology's burgeoning stable of registries will likely include one to collect outpatient data by late this year or early next year, according to the organization.

Ten years ago, the ACC launched the National Cardiovascular Data Registry (NCDR). It has subsequently launched the CathPCI Registry, the ICD Registry, and, just last year, the CARE (Carotid Artery Revascularization and Endarterectomy) Registry, all of which are centered on hospital-based procedures.

Clearly, outpatient data represent both a gap and an opportunity, Dr. Ralph Brindis, chief medical officer for the NCDR, said in an interview. “As we've developed an increasing portfolio, there's been a lot of interest among cardiologists and payers, and interest from the American Board of Internal Medicine, in how we can actually assess quality in the outpatient arena,” he continued.

Pharmaceutical manufacturers are also interested in outpatient registries to help assess long-term safety and efficacy of medications, he said.

The outpatient effort, tentatively dubbed IC3 (Improving Continuity in Cardiac Care), is in the beginning stages, with protocols, data collection tools, and reports being developed. After securing industry funding for the launch, the registry will be piloted at 100–150 physician offices across the United States next summer, Dr. Brindis said. Within a year, ACC hopes to have 400 offices enrolled and perhaps more than 1,000 in 2–3 years.

Initially, the focus will be on patients who are post discharge for acute coronary syndrome. Physicians will be asked to submit data on meeting performance goals related to prescribing evidence-based therapies such as aspirin, β-blockers, and ACE inhibitors, and how well patients and physicians do in meeting cholesterol goals.

Over time, measures will likely expand to meeting benchmarks for hypertension and heart failure treatment, and perhaps appropriateness of imaging studies, Dr. Brindis said. Eventually, the registry might be used to help physicians meet reporting needs and maintain certification through the ABIM, he said.

The registry would be voluntary. Dr. Brindis said there would be some effort to make it manageable for practices that aren't heavily invested in health information technology.

Also, Dr. Brindis said, the ACC might initially provide payments to the pilot participants, but, he added, “In the long run, hopefully, there would be so much added value that we wouldn't pay them to participate.”

The American College of Cardiology's burgeoning stable of registries will likely include one to collect outpatient data by late this year or early next year, according to the organization.

Ten years ago, the ACC launched the National Cardiovascular Data Registry (NCDR). It has subsequently launched the CathPCI Registry, the ICD Registry, and, just last year, the CARE (Carotid Artery Revascularization and Endarterectomy) Registry, all of which are centered on hospital-based procedures.

Clearly, outpatient data represent both a gap and an opportunity, Dr. Ralph Brindis, chief medical officer for the NCDR, said in an interview. “As we've developed an increasing portfolio, there's been a lot of interest among cardiologists and payers, and interest from the American Board of Internal Medicine, in how we can actually assess quality in the outpatient arena,” he continued.

Pharmaceutical manufacturers are also interested in outpatient registries to help assess long-term safety and efficacy of medications, he said.

The outpatient effort, tentatively dubbed IC3 (Improving Continuity in Cardiac Care), is in the beginning stages, with protocols, data collection tools, and reports being developed. After securing industry funding for the launch, the registry will be piloted at 100–150 physician offices across the United States next summer, Dr. Brindis said. Within a year, ACC hopes to have 400 offices enrolled and perhaps more than 1,000 in 2–3 years.

Initially, the focus will be on patients who are post discharge for acute coronary syndrome. Physicians will be asked to submit data on meeting performance goals related to prescribing evidence-based therapies such as aspirin, β-blockers, and ACE inhibitors, and how well patients and physicians do in meeting cholesterol goals.

Over time, measures will likely expand to meeting benchmarks for hypertension and heart failure treatment, and perhaps appropriateness of imaging studies, Dr. Brindis said. Eventually, the registry might be used to help physicians meet reporting needs and maintain certification through the ABIM, he said.

The registry would be voluntary. Dr. Brindis said there would be some effort to make it manageable for practices that aren't heavily invested in health information technology.

Also, Dr. Brindis said, the ACC might initially provide payments to the pilot participants, but, he added, “In the long run, hopefully, there would be so much added value that we wouldn't pay them to participate.”

CMS Extends Form Deadline

The Centers for Medicare and Medicaid Services has extended the deadline for filing Medicare claims using its new version of claims form CMS-1500, because of formatting errors on the revised form, CMS announced. The original deadline for switching to the new form—known as CMS-1500 (08/05)—originally was April 2. But CMS said last month that contractors have been directed to continue to accept the old form until the agency notifies them to stop. Additionally, the agency advised physicians who must use the form to use legacy provider numbers, as the form cannot accommodate a National Provider Identifier (NPI) number.

New Imaging-Cut Moratorium

Several members of Congress introduced legislation last month to place a 2-year moratorium on cuts to Medicare payments for medical imaging that went into effect this year. The bill also requires a Government Accountability Office study of patient access to imaging. The bill—H.R. 1293—was introduced by Reps. Carolyn McCarthy (D-N.Y.), Gene Green (D-Tex.), and Joseph Pitts (R-Penn.), and had 49 cosponsors at press time. Rep. Pitts sponsored similar legislation in the last Congress; the cuts were mandated as part of the Deficit Reduction Act of 2005. A Senate companion bill is expected soon. Under the DRA, payments for the technical component of an imaging service are to be set at the hospital outpatient-department rate, if the payment under the Medicare physician fee schedule is higher. The Access to Medical Imaging Coalition said that a new report by the Moran Co. shows that the DRA mandate means physicians face reimbursement that's 18%–19% below that for outpatient departments. “The fact is, the DRA has decimated the imaging payments received by cardiologists, radiologists, and other providers,” said Tim Trysla, executive director of the coalition.

Stroke Networks Supported

The House Energy and Commerce Committee has approved the Stroke Treatment and Ongoing Prevention Act of 2007 (H.R. 477). That bill was introduced by Rep. Lois Capps (D-Calif.) and Rep. Charles Pickering (R-Miss.), and would fund a public awareness campaign to urge Americans to seek prompt treatment. It will also provide funds for the Paul Coverdell National Acute Stroke Registry and Clearinghouse at the Centers for Disease Control and Prevention, and also $50 million in grants from fiscal year 2008 to fiscal year 2012 to promote telemedicine to broaden access to immediate and high-quality stroke care. “The STOP Stroke Act will help save lives by enhancing awareness about stroke symptoms and ensuring that those who suffer a stroke are treated as rapidly as possible with the most appropriate therapy,” said Dr. Ralph Sacco, chairman of the American Stroke Association Stroke Advisory Committee.

Heart Hospitals = More Procedures

A study in the March 7 Journal of the American Medical Association found a higher volume of cardiac revascularization procedures in areas that gained specialty heart hospitals. Overall, the mean procedural volume in Medicare beneficiaries was fourfold higher at specialty hospitals than at cardiac programs at general hospitals, said the authors from the University of Michigan, Ann Arbor; the VA Ann Arbor Healthcare System; Harvard Medical School, Boston; and Yale University, New Haven. “These findings raise the concern that the opening of cardiac hospitals may lead to greater procedural utilization beyond the simple addition of capacity to a market,” they wrote. The rate of percutaneous coronary interventions (PCI) was higher for patients who had not had an acute myocardial infarction, which was of concern because the benefits of PCI in this group are not clear, said the author. There are several potential explanations for the higher volume: physician owners who refer for financial gain; specialty facilities that perhaps open in markets that are predisposed to higher revascularization rates because of patient characteristics; or general hospitals that more aggressively compete with the specialty facilities, driving up overall volume. The Agency for Healthcare Research and Quality paid for the study.

Prescription Drug Sales Up

U.S. prescription drug sales grew more than 8% to $275 billion in 2006, fueled by the Medicare Part D prescription benefit, increased use of generics within new therapy classes, and new drug launches, said the pharmaceutical data firm IMS Health Inc. Total dispensed prescriptions grew at nearly a 5% pace, compared with slightly more than 3% in 2005, the firm said. Part D was a large driver of the upward trend, lifting prescription volume by an estimated 1 to 2 percentage points and pharmaceutical sales by about 1 percentage point. The benefit “increased prescription coverage to the previously uninsured and underinsured, and provided generous plan benefits to seniors,” said Diana Conmy, corporate director, IMS Market Insights, in a statement. Sales of prescription drugs in the United States are expected to decline in 2007, IMS Health said.

FDA to Study DTC Risk Data

The Food and Drug Administration says it is concerned about how much risk information is disclosed to consumers in print ads and that the information is not usually in a consumer-friendly format. The agency plans to study how to improve the presentation of such information. One study will look at whether giving consumers more context—instead of a list of risks, for instance—will aid their understanding of a product's potential downside. Another will look at the usefulness of several different formats for presenting the data. Comments on the proposed testing will be accepted until mid-April.

CMS Extends Form Deadline

The Centers for Medicare and Medicaid Services has extended the deadline for filing Medicare claims using its new version of claims form CMS-1500, because of formatting errors on the revised form, CMS announced. The original deadline for switching to the new form—known as CMS-1500 (08/05)—originally was April 2. But CMS said last month that contractors have been directed to continue to accept the old form until the agency notifies them to stop. Additionally, the agency advised physicians who must use the form to use legacy provider numbers, as the form cannot accommodate a National Provider Identifier (NPI) number.

New Imaging-Cut Moratorium

Several members of Congress introduced legislation last month to place a 2-year moratorium on cuts to Medicare payments for medical imaging that went into effect this year. The bill also requires a Government Accountability Office study of patient access to imaging. The bill—H.R. 1293—was introduced by Reps. Carolyn McCarthy (D-N.Y.), Gene Green (D-Tex.), and Joseph Pitts (R-Penn.), and had 49 cosponsors at press time. Rep. Pitts sponsored similar legislation in the last Congress; the cuts were mandated as part of the Deficit Reduction Act of 2005. A Senate companion bill is expected soon. Under the DRA, payments for the technical component of an imaging service are to be set at the hospital outpatient-department rate, if the payment under the Medicare physician fee schedule is higher. The Access to Medical Imaging Coalition said that a new report by the Moran Co. shows that the DRA mandate means physicians face reimbursement that's 18%–19% below that for outpatient departments. “The fact is, the DRA has decimated the imaging payments received by cardiologists, radiologists, and other providers,” said Tim Trysla, executive director of the coalition.

Stroke Networks Supported

The House Energy and Commerce Committee has approved the Stroke Treatment and Ongoing Prevention Act of 2007 (H.R. 477). That bill was introduced by Rep. Lois Capps (D-Calif.) and Rep. Charles Pickering (R-Miss.), and would fund a public awareness campaign to urge Americans to seek prompt treatment. It will also provide funds for the Paul Coverdell National Acute Stroke Registry and Clearinghouse at the Centers for Disease Control and Prevention, and also $50 million in grants from fiscal year 2008 to fiscal year 2012 to promote telemedicine to broaden access to immediate and high-quality stroke care. “The STOP Stroke Act will help save lives by enhancing awareness about stroke symptoms and ensuring that those who suffer a stroke are treated as rapidly as possible with the most appropriate therapy,” said Dr. Ralph Sacco, chairman of the American Stroke Association Stroke Advisory Committee.

Heart Hospitals = More Procedures

A study in the March 7 Journal of the American Medical Association found a higher volume of cardiac revascularization procedures in areas that gained specialty heart hospitals. Overall, the mean procedural volume in Medicare beneficiaries was fourfold higher at specialty hospitals than at cardiac programs at general hospitals, said the authors from the University of Michigan, Ann Arbor; the VA Ann Arbor Healthcare System; Harvard Medical School, Boston; and Yale University, New Haven. “These findings raise the concern that the opening of cardiac hospitals may lead to greater procedural utilization beyond the simple addition of capacity to a market,” they wrote. The rate of percutaneous coronary interventions (PCI) was higher for patients who had not had an acute myocardial infarction, which was of concern because the benefits of PCI in this group are not clear, said the author. There are several potential explanations for the higher volume: physician owners who refer for financial gain; specialty facilities that perhaps open in markets that are predisposed to higher revascularization rates because of patient characteristics; or general hospitals that more aggressively compete with the specialty facilities, driving up overall volume. The Agency for Healthcare Research and Quality paid for the study.

Prescription Drug Sales Up

U.S. prescription drug sales grew more than 8% to $275 billion in 2006, fueled by the Medicare Part D prescription benefit, increased use of generics within new therapy classes, and new drug launches, said the pharmaceutical data firm IMS Health Inc. Total dispensed prescriptions grew at nearly a 5% pace, compared with slightly more than 3% in 2005, the firm said. Part D was a large driver of the upward trend, lifting prescription volume by an estimated 1 to 2 percentage points and pharmaceutical sales by about 1 percentage point. The benefit “increased prescription coverage to the previously uninsured and underinsured, and provided generous plan benefits to seniors,” said Diana Conmy, corporate director, IMS Market Insights, in a statement. Sales of prescription drugs in the United States are expected to decline in 2007, IMS Health said.

FDA to Study DTC Risk Data

The Food and Drug Administration says it is concerned about how much risk information is disclosed to consumers in print ads and that the information is not usually in a consumer-friendly format. The agency plans to study how to improve the presentation of such information. One study will look at whether giving consumers more context—instead of a list of risks, for instance—will aid their understanding of a product's potential downside. Another will look at the usefulness of several different formats for presenting the data. Comments on the proposed testing will be accepted until mid-April.

CMS Extends Form Deadline

The Centers for Medicare and Medicaid Services has extended the deadline for filing Medicare claims using its new version of claims form CMS-1500, because of formatting errors on the revised form, CMS announced. The original deadline for switching to the new form—known as CMS-1500 (08/05)—originally was April 2. But CMS said last month that contractors have been directed to continue to accept the old form until the agency notifies them to stop. Additionally, the agency advised physicians who must use the form to use legacy provider numbers, as the form cannot accommodate a National Provider Identifier (NPI) number.

New Imaging-Cut Moratorium

Several members of Congress introduced legislation last month to place a 2-year moratorium on cuts to Medicare payments for medical imaging that went into effect this year. The bill also requires a Government Accountability Office study of patient access to imaging. The bill—H.R. 1293—was introduced by Reps. Carolyn McCarthy (D-N.Y.), Gene Green (D-Tex.), and Joseph Pitts (R-Penn.), and had 49 cosponsors at press time. Rep. Pitts sponsored similar legislation in the last Congress; the cuts were mandated as part of the Deficit Reduction Act of 2005. A Senate companion bill is expected soon. Under the DRA, payments for the technical component of an imaging service are to be set at the hospital outpatient-department rate, if the payment under the Medicare physician fee schedule is higher. The Access to Medical Imaging Coalition said that a new report by the Moran Co. shows that the DRA mandate means physicians face reimbursement that's 18%–19% below that for outpatient departments. “The fact is, the DRA has decimated the imaging payments received by cardiologists, radiologists, and other providers,” said Tim Trysla, executive director of the coalition.

Stroke Networks Supported

The House Energy and Commerce Committee has approved the Stroke Treatment and Ongoing Prevention Act of 2007 (H.R. 477). That bill was introduced by Rep. Lois Capps (D-Calif.) and Rep. Charles Pickering (R-Miss.), and would fund a public awareness campaign to urge Americans to seek prompt treatment. It will also provide funds for the Paul Coverdell National Acute Stroke Registry and Clearinghouse at the Centers for Disease Control and Prevention, and also $50 million in grants from fiscal year 2008 to fiscal year 2012 to promote telemedicine to broaden access to immediate and high-quality stroke care. “The STOP Stroke Act will help save lives by enhancing awareness about stroke symptoms and ensuring that those who suffer a stroke are treated as rapidly as possible with the most appropriate therapy,” said Dr. Ralph Sacco, chairman of the American Stroke Association Stroke Advisory Committee.

Heart Hospitals = More Procedures

A study in the March 7 Journal of the American Medical Association found a higher volume of cardiac revascularization procedures in areas that gained specialty heart hospitals. Overall, the mean procedural volume in Medicare beneficiaries was fourfold higher at specialty hospitals than at cardiac programs at general hospitals, said the authors from the University of Michigan, Ann Arbor; the VA Ann Arbor Healthcare System; Harvard Medical School, Boston; and Yale University, New Haven. “These findings raise the concern that the opening of cardiac hospitals may lead to greater procedural utilization beyond the simple addition of capacity to a market,” they wrote. The rate of percutaneous coronary interventions (PCI) was higher for patients who had not had an acute myocardial infarction, which was of concern because the benefits of PCI in this group are not clear, said the author. There are several potential explanations for the higher volume: physician owners who refer for financial gain; specialty facilities that perhaps open in markets that are predisposed to higher revascularization rates because of patient characteristics; or general hospitals that more aggressively compete with the specialty facilities, driving up overall volume. The Agency for Healthcare Research and Quality paid for the study.

Prescription Drug Sales Up

U.S. prescription drug sales grew more than 8% to $275 billion in 2006, fueled by the Medicare Part D prescription benefit, increased use of generics within new therapy classes, and new drug launches, said the pharmaceutical data firm IMS Health Inc. Total dispensed prescriptions grew at nearly a 5% pace, compared with slightly more than 3% in 2005, the firm said. Part D was a large driver of the upward trend, lifting prescription volume by an estimated 1 to 2 percentage points and pharmaceutical sales by about 1 percentage point. The benefit “increased prescription coverage to the previously uninsured and underinsured, and provided generous plan benefits to seniors,” said Diana Conmy, corporate director, IMS Market Insights, in a statement. Sales of prescription drugs in the United States are expected to decline in 2007, IMS Health said.

FDA to Study DTC Risk Data

The Food and Drug Administration says it is concerned about how much risk information is disclosed to consumers in print ads and that the information is not usually in a consumer-friendly format. The agency plans to study how to improve the presentation of such information. One study will look at whether giving consumers more context—instead of a list of risks, for instance—will aid their understanding of a product's potential downside. Another will look at the usefulness of several different formats for presenting the data. Comments on the proposed testing will be accepted until mid-April.

WASHINGTON — Food and Drug Administration officials said they have started several new initiatives in response to the Institute of Medicine's call to overhaul drug safety efforts. The projects, including one 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 lambasting 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, associate director for medical policy at the FDA.

The FDA's Center for Drug Evaluation and Research 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 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 on its Web site up-to-date information on a drug's postmarketing experience.

In addition, the IOM report urged Congress to give the FDA greater enforcement powers to compel pharmaceutical manufacturers to fulfill commitments to gather postmarketing data.

Peter Barton Hutt, a former FDA general counsel and now senior counsel with Covington and Burling in Washington, said FDA had all the enforcement power it needed already; however, it does need more funding outside of the user fees it collects.

Critics have said the FDA is unduly beholden to industry because of user fees. Former FDA Deputy Commissioner Mary Pendergast noted that 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 fiscal 2006 report to Congress, 63% of those studies had not been started, she said.

WASHINGTON — Food and Drug Administration officials said they have started several new initiatives in response to the Institute of Medicine's call to overhaul drug safety efforts. The projects, including one 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 lambasting 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, associate director for medical policy at the FDA.

The FDA's Center for Drug Evaluation and Research 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 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 on its Web site up-to-date information on a drug's postmarketing experience.

In addition, the IOM report urged Congress to give the FDA greater enforcement powers to compel pharmaceutical manufacturers to fulfill commitments to gather postmarketing data.

Peter Barton Hutt, a former FDA general counsel and now senior counsel with Covington and Burling in Washington, said FDA had all the enforcement power it needed already; however, it does need more funding outside of the user fees it collects.

Critics have said the FDA is unduly beholden to industry because of user fees. Former FDA Deputy Commissioner Mary Pendergast noted that 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 fiscal 2006 report to Congress, 63% of those studies had not been started, she said.

WASHINGTON — Food and Drug Administration officials said they have started several new initiatives in response to the Institute of Medicine's call to overhaul drug safety efforts. The projects, including one 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 lambasting 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, associate director for medical policy at the FDA.

The FDA's Center for Drug Evaluation and Research 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 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 on its Web site up-to-date information on a drug's postmarketing experience.

In addition, the IOM report urged Congress to give the FDA greater enforcement powers to compel pharmaceutical manufacturers to fulfill commitments to gather postmarketing data.

Peter Barton Hutt, a former FDA general counsel and now senior counsel with Covington and Burling in Washington, said FDA had all the enforcement power it needed already; however, it does need more funding outside of the user fees it collects.

Critics have said the FDA is unduly beholden to industry because of user fees. Former FDA Deputy Commissioner Mary Pendergast noted that 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 fiscal 2006 report to Congress, 63% of those studies had not been started, she said.

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.

Mr. Lutter and other agency officials would not say how they came up with the $50,000 threshold or how many current advisory panel members might be disqualified based on that figure.

However, said Mr. Lutter, “our judgment is, it is a significant number.”

The restriction applies to stocks and investments, primary employment, consulting work, contracts and grants, royalties, expert witness work, and speaking and writing fees. It does not apply to mutual funds.

The $50,000 figure will be increased each year in line with the consumer price index, according to the proposal.

A critic of the FDA's conflict-of-interest policies said the new guidance is a significant step forward in part because it will bar participants from voting if they have a financial conflict. They “will be identified as committee members with a taint,” said Peter Lurie, deputy director of Public Citizen's Health Research Group.

In the past, even nonvoting members could influence a panel's decision, he said, adding that the new proposal will act as a “countermeasure.”

The proposed rules also could “drive the conflict rate lower,” said Mr. Lurie, noting that when it comes to recruiting new advisory committee members, “there's going to be a premium on finding those who don't have conflicts.”

The guidance document was posted on the FDA's Web site on March 21. Once it is published in the Federal Register, it will be open for public comment for 60 days. The agency expects to incorporate suggestions and issue the final guidance shortly after that time, said Mr. Lutter.

To submit electronic comments on the draft guidance, visit www.regulations.govwww.fda.gov/dockets/ecomments

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.

Mr. Lutter and other agency officials would not say how they came up with the $50,000 threshold or how many current advisory panel members might be disqualified based on that figure.

However, said Mr. Lutter, “our judgment is, it is a significant number.”

The restriction applies to stocks and investments, primary employment, consulting work, contracts and grants, royalties, expert witness work, and speaking and writing fees. It does not apply to mutual funds.

The $50,000 figure will be increased each year in line with the consumer price index, according to the proposal.

A critic of the FDA's conflict-of-interest policies said the new guidance is a significant step forward in part because it will bar participants from voting if they have a financial conflict. They “will be identified as committee members with a taint,” said Peter Lurie, deputy director of Public Citizen's Health Research Group.

In the past, even nonvoting members could influence a panel's decision, he said, adding that the new proposal will act as a “countermeasure.”

The proposed rules also could “drive the conflict rate lower,” said Mr. Lurie, noting that when it comes to recruiting new advisory committee members, “there's going to be a premium on finding those who don't have conflicts.”

The guidance document was posted on the FDA's Web site on March 21. Once it is published in the Federal Register, it will be open for public comment for 60 days. The agency expects to incorporate suggestions and issue the final guidance shortly after that time, said Mr. Lutter.

To submit electronic comments on the draft guidance, visit www.regulations.govwww.fda.gov/dockets/ecomments

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.

Mr. Lutter and other agency officials would not say how they came up with the $50,000 threshold or how many current advisory panel members might be disqualified based on that figure.

However, said Mr. Lutter, “our judgment is, it is a significant number.”

The restriction applies to stocks and investments, primary employment, consulting work, contracts and grants, royalties, expert witness work, and speaking and writing fees. It does not apply to mutual funds.

The $50,000 figure will be increased each year in line with the consumer price index, according to the proposal.

A critic of the FDA's conflict-of-interest policies said the new guidance is a significant step forward in part because it will bar participants from voting if they have a financial conflict. They “will be identified as committee members with a taint,” said Peter Lurie, deputy director of Public Citizen's Health Research Group.

In the past, even nonvoting members could influence a panel's decision, he said, adding that the new proposal will act as a “countermeasure.”

The proposed rules also could “drive the conflict rate lower,” said Mr. Lurie, noting that when it comes to recruiting new advisory committee members, “there's going to be a premium on finding those who don't have conflicts.”

The guidance document was posted on the FDA's Web site on March 21. Once it is published in the Federal Register, it will be open for public comment for 60 days. The agency expects to incorporate suggestions and issue the final guidance shortly after that time, said Mr. Lutter.

To submit electronic comments on the draft guidance, visit www.regulations.govwww.fda.gov/dockets/ecomments

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 an incentive payment to physicians who make the move to electronic medical records.

Adopting 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. “Right now there are inadequate incentives for health care providers to adopt many of these technologies,” he said.

“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,” added 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 also noted that the full Small Business Committee recently passed the Small Business Lending Improvements Act of 2007 (H.R. 1332). That 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. To help defray both the initial investment and ongoing maintenance costs, ACP advocates an add-on payment from Medicare scaled to the complexity of the technology. The initial capital costs could be offset by 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. The Hawaii Medical Service Association (Blue Cross and Blue Shield of Hawaii) announced in November 2006 that it was setting aside $20 million to help individual physicians buy EMR systems, though it required those investments to be in CCHIT-certified systems.

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 the ability to access patient charts 24 hours a day, she said.

Similarly, Dr. David O. Shober said that buying and implementing an EMR system at his two-physician family practice has been draining but beneficial. In 2004, the practice—then comprising 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 physicians have run into obstacles, including the inability of their system to communicate with radiology centers and labs, and the refusal of many pharmacies in their community 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. The physicians are financing the system at a cost of $1,000 a month each, and their payments will continue for the next 3 years, he said.

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 an incentive payment to physicians who make the move to electronic medical records.

Adopting 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. “Right now there are inadequate incentives for health care providers to adopt many of these technologies,” he said.

“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,” added 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 also noted that the full Small Business Committee recently passed the Small Business Lending Improvements Act of 2007 (H.R. 1332). That 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. To help defray both the initial investment and ongoing maintenance costs, ACP advocates an add-on payment from Medicare scaled to the complexity of the technology. The initial capital costs could be offset by 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. The Hawaii Medical Service Association (Blue Cross and Blue Shield of Hawaii) announced in November 2006 that it was setting aside $20 million to help individual physicians buy EMR systems, though it required those investments to be in CCHIT-certified systems.

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 the ability to access patient charts 24 hours a day, she said.

Similarly, Dr. David O. Shober said that buying and implementing an EMR system at his two-physician family practice has been draining but beneficial. In 2004, the practice—then comprising 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 physicians have run into obstacles, including the inability of their system to communicate with radiology centers and labs, and the refusal of many pharmacies in their community 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. The physicians are financing the system at a cost of $1,000 a month each, and their payments will continue for the next 3 years, he said.

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 an incentive payment to physicians who make the move to electronic medical records.

Adopting 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. “Right now there are inadequate incentives for health care providers to adopt many of these technologies,” he said.

“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,” added 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 also noted that the full Small Business Committee recently passed the Small Business Lending Improvements Act of 2007 (H.R. 1332). That 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. To help defray both the initial investment and ongoing maintenance costs, ACP advocates an add-on payment from Medicare scaled to the complexity of the technology. The initial capital costs could be offset by 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. The Hawaii Medical Service Association (Blue Cross and Blue Shield of Hawaii) announced in November 2006 that it was setting aside $20 million to help individual physicians buy EMR systems, though it required those investments to be in CCHIT-certified systems.

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 the ability to access patient charts 24 hours a day, she said.

Similarly, Dr. David O. Shober said that buying and implementing an EMR system at his two-physician family practice has been draining but beneficial. In 2004, the practice—then comprising 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 physicians have run into obstacles, including the inability of their system to communicate with radiology centers and labs, and the refusal of many pharmacies in their community 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. The physicians are financing the system at a cost of $1,000 a month each, and their payments will continue for the next 3 years, he said.

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.