Mary Ellen Schneider

Officials at the National Institutes of Health are tightening restrictions on outside consulting arrangements with industry after more than a year of investigations turned up potential conflicts of interest.

“Nothing is more important to me than preserving the trust of the public in NIH,” Elias A. Zerhouni, M.D., NIH director, said in a statement announcing the new ethics rules. “It is unfortunate that the activities of a few employees have tainted the stellar reputation of the many thousands of NIH scientists who have never compromised their integrity and have selflessly served the nation with great distinction through their discoveries.”

The new policy bars all NIH employees from engaging in compensated or uncompensated employment, or consulting relationships with those organizations that are substantially affected by NIH decisions.

Such organizations include pharmaceutical manufacturers, biotechnology companies, support research institutions, health care providers and insurers, and related trade and professional associations. The policy also prohibits NIH employees from participating in compensated teaching, speaking, writing, or editing with these affected organizations.

Further, all NIH employees are prohibited from self-employment activities that involve the sale or promotion of services or products from these affected organizations.

However, employees are allowed to teach courses that require multiple presentations and are part of an established curriculum at a university or college. They can also teach, speak, or write as part of a continuing education program.

But if the funding for the program comes from a substantially affected organization, like a drug company, it must be funded by an unrestricted grant.

NIH employees also can author articles, chapters, and textbooks that are subject to peer review, provided that funding from affected organizations is provided in the form of unrestricted contributions.

Under the new policy, NIH employees are also allowed to continue clinical care to individual patients.

The new regulation also takes aim at stock ownership. NIH employees who are required to file financial disclosure statements are prohibited from acquiring or holding financial interests in affected organizations including biotechnology, pharmaceutical, and medical device companies. All other NIH employees are subject to a $15,000 cap on such holdings.

“This new policy is an extension of a profession-wide examination of physicians' relationships to industry,” said William E. Golden, M.D., professor of medicine and public health at the University of Arkansas in Little Rock.

Medical schools are likely to be the next major institutions to seek out greater transparency in the relationships between their faculty members and industry, Dr. Golden predicted.

The interim final regulation was developed by the Department of Health and Human Services with the Office of Government Ethics and went into effect immediately. Officials at HHS will continue to review the impact of the regulation and work on developing a comprehensive policy regarding outside consulting activities.

The new policy comes after about a year of internal NIH investigations as well as congressional inquiries into consulting arrangements between NIH employees and outside companies. NIH officials had previously proposed a 1-year moratorium on all outside consulting arrangements.

“Though I believe that some outside activities are in the best interest of the public when designed to accelerate the development of new discoveries, we must first have better oversight systems to ensure transparency and sound ethical practices and procedures,” Dr. Zerhouni said.

The new policy was praised by the Association of American Medical Colleges. “The rules are clear and unambiguous and will enhance the public's confidence in the integrity and dedication of NIH employees and scientists,” AAMC President Jordan J. Cohen, M.D., said in statement.

“We also firmly support NIH's plan to assess the impact of these new rules within 1 year. Given the sweeping changes being made and the possibility of unintended consequences, it is prudent for the agency to undertake a thorough review after full implementation so that appropriate modifications can be made, if necessary,” Dr. Cohen said.

Officials at NIH also announced a new policy aimed at speeding the public's access to scientific articles that result from NIH-funded research. Under the policy, the agency is calling on scientists to voluntarily release manuscripts supported by NIH to the public within a year of peer-reviewed publication.

These articles would then be made available online in an archive to be managed by the National Library of Medicine.

Officials at the National Institutes of Health are tightening restrictions on outside consulting arrangements with industry after more than a year of investigations turned up potential conflicts of interest.

“Nothing is more important to me than preserving the trust of the public in NIH,” Elias A. Zerhouni, M.D., NIH director, said in a statement announcing the new ethics rules. “It is unfortunate that the activities of a few employees have tainted the stellar reputation of the many thousands of NIH scientists who have never compromised their integrity and have selflessly served the nation with great distinction through their discoveries.”

The new policy bars all NIH employees from engaging in compensated or uncompensated employment, or consulting relationships with those organizations that are substantially affected by NIH decisions.

Such organizations include pharmaceutical manufacturers, biotechnology companies, support research institutions, health care providers and insurers, and related trade and professional associations. The policy also prohibits NIH employees from participating in compensated teaching, speaking, writing, or editing with these affected organizations.

Further, all NIH employees are prohibited from self-employment activities that involve the sale or promotion of services or products from these affected organizations.

However, employees are allowed to teach courses that require multiple presentations and are part of an established curriculum at a university or college. They can also teach, speak, or write as part of a continuing education program.

But if the funding for the program comes from a substantially affected organization, like a drug company, it must be funded by an unrestricted grant.

NIH employees also can author articles, chapters, and textbooks that are subject to peer review, provided that funding from affected organizations is provided in the form of unrestricted contributions.

Under the new policy, NIH employees are also allowed to continue clinical care to individual patients.

The new regulation also takes aim at stock ownership. NIH employees who are required to file financial disclosure statements are prohibited from acquiring or holding financial interests in affected organizations including biotechnology, pharmaceutical, and medical device companies. All other NIH employees are subject to a $15,000 cap on such holdings.

“This new policy is an extension of a profession-wide examination of physicians' relationships to industry,” said William E. Golden, M.D., professor of medicine and public health at the University of Arkansas in Little Rock.

Medical schools are likely to be the next major institutions to seek out greater transparency in the relationships between their faculty members and industry, Dr. Golden predicted.

The interim final regulation was developed by the Department of Health and Human Services with the Office of Government Ethics and went into effect immediately. Officials at HHS will continue to review the impact of the regulation and work on developing a comprehensive policy regarding outside consulting activities.

The new policy comes after about a year of internal NIH investigations as well as congressional inquiries into consulting arrangements between NIH employees and outside companies. NIH officials had previously proposed a 1-year moratorium on all outside consulting arrangements.

“Though I believe that some outside activities are in the best interest of the public when designed to accelerate the development of new discoveries, we must first have better oversight systems to ensure transparency and sound ethical practices and procedures,” Dr. Zerhouni said.

The new policy was praised by the Association of American Medical Colleges. “The rules are clear and unambiguous and will enhance the public's confidence in the integrity and dedication of NIH employees and scientists,” AAMC President Jordan J. Cohen, M.D., said in statement.

“We also firmly support NIH's plan to assess the impact of these new rules within 1 year. Given the sweeping changes being made and the possibility of unintended consequences, it is prudent for the agency to undertake a thorough review after full implementation so that appropriate modifications can be made, if necessary,” Dr. Cohen said.

Officials at NIH also announced a new policy aimed at speeding the public's access to scientific articles that result from NIH-funded research. Under the policy, the agency is calling on scientists to voluntarily release manuscripts supported by NIH to the public within a year of peer-reviewed publication.

These articles would then be made available online in an archive to be managed by the National Library of Medicine.

Officials at the National Institutes of Health are tightening restrictions on outside consulting arrangements with industry after more than a year of investigations turned up potential conflicts of interest.

“Nothing is more important to me than preserving the trust of the public in NIH,” Elias A. Zerhouni, M.D., NIH director, said in a statement announcing the new ethics rules. “It is unfortunate that the activities of a few employees have tainted the stellar reputation of the many thousands of NIH scientists who have never compromised their integrity and have selflessly served the nation with great distinction through their discoveries.”

The new policy bars all NIH employees from engaging in compensated or uncompensated employment, or consulting relationships with those organizations that are substantially affected by NIH decisions.

Such organizations include pharmaceutical manufacturers, biotechnology companies, support research institutions, health care providers and insurers, and related trade and professional associations. The policy also prohibits NIH employees from participating in compensated teaching, speaking, writing, or editing with these affected organizations.

Further, all NIH employees are prohibited from self-employment activities that involve the sale or promotion of services or products from these affected organizations.

However, employees are allowed to teach courses that require multiple presentations and are part of an established curriculum at a university or college. They can also teach, speak, or write as part of a continuing education program.

But if the funding for the program comes from a substantially affected organization, like a drug company, it must be funded by an unrestricted grant.

NIH employees also can author articles, chapters, and textbooks that are subject to peer review, provided that funding from affected organizations is provided in the form of unrestricted contributions.

Under the new policy, NIH employees are also allowed to continue clinical care to individual patients.

The new regulation also takes aim at stock ownership. NIH employees who are required to file financial disclosure statements are prohibited from acquiring or holding financial interests in affected organizations including biotechnology, pharmaceutical, and medical device companies. All other NIH employees are subject to a $15,000 cap on such holdings.

“This new policy is an extension of a profession-wide examination of physicians' relationships to industry,” said William E. Golden, M.D., professor of medicine and public health at the University of Arkansas in Little Rock.

Medical schools are likely to be the next major institutions to seek out greater transparency in the relationships between their faculty members and industry, Dr. Golden predicted.

The interim final regulation was developed by the Department of Health and Human Services with the Office of Government Ethics and went into effect immediately. Officials at HHS will continue to review the impact of the regulation and work on developing a comprehensive policy regarding outside consulting activities.

The new policy comes after about a year of internal NIH investigations as well as congressional inquiries into consulting arrangements between NIH employees and outside companies. NIH officials had previously proposed a 1-year moratorium on all outside consulting arrangements.

“Though I believe that some outside activities are in the best interest of the public when designed to accelerate the development of new discoveries, we must first have better oversight systems to ensure transparency and sound ethical practices and procedures,” Dr. Zerhouni said.

The new policy was praised by the Association of American Medical Colleges. “The rules are clear and unambiguous and will enhance the public's confidence in the integrity and dedication of NIH employees and scientists,” AAMC President Jordan J. Cohen, M.D., said in statement.

“We also firmly support NIH's plan to assess the impact of these new rules within 1 year. Given the sweeping changes being made and the possibility of unintended consequences, it is prudent for the agency to undertake a thorough review after full implementation so that appropriate modifications can be made, if necessary,” Dr. Cohen said.

Officials at NIH also announced a new policy aimed at speeding the public's access to scientific articles that result from NIH-funded research. Under the policy, the agency is calling on scientists to voluntarily release manuscripts supported by NIH to the public within a year of peer-reviewed publication.

These articles would then be made available online in an archive to be managed by the National Library of Medicine.

Most group practices are still using paper medical records and charts, according to preliminary results from a survey by the Medical Group Management Association.

“Paper is still the dominant mode of data collection,” William F. Jessee, M.D., president and CEO of the Medical Group Management Association (MGMA) said in a webcast sponsored by the group.

But the scale is tipping, he said. About 20% of group practices report that they have an electronic health record of some kind. In addition, 8% have a dictation and transcription system for physician notes, combined with a document imaging management system for information received on paper.

“We're seeing a steady movement toward a paperless office,” Dr. Jessee said.

The preliminary findings are based on responses from about 1,000 group practices that responded to an electronic questionnaire. The second stage of the survey will include mailing more than 16,000 printed questionnaires to a sample of group practices across the country. Complete results from the survey are expected this spring.

The survey is part of a contract from the Agency for Healthcare Research and Quality to MGMA's Center for Research and the University of Minnesota. The purpose of the contract is to provide a baseline that describes the use of new information technologies in medical groups.

Some of the challenges physicians face in making the transition to an electronic health record include knowing which product to buy, how to go about buying it, and how to implement the system, said David Brailer, M.D., national health information technology coordinator for the Department of Health and Human Services.

“Many groups stumble at every point along the way,” Dr. Brailer said.

The private industry is working to create a voluntary certification process for electronic health record products.

The American Health Information Management Association, the Healthcare Information and Management Systems Society, and the National Alliance for Health Information Technology have formed a nonprofit group—the Certification Commission for Healthcare Information Technology—that is planning to pilot a first-step certification process this summer.

Dr. Brailer also plans to explore interoperability issues. It is not enough to have every practice using an electronic health record, he said. They also have to be able to share information with other providers and institutions. HHS already has asked the industry for comments on how to design a mechanism that would allow physicians and other health care providers to share information across the health care system.

The agency is now reviewing the more than 500 responses on how to address the legal, economic, privacy, and technical concerns involved in creating an interoperable system, Dr. Brailer said.

Most group practices are still using paper medical records and charts, according to preliminary results from a survey by the Medical Group Management Association.

“Paper is still the dominant mode of data collection,” William F. Jessee, M.D., president and CEO of the Medical Group Management Association (MGMA) said in a webcast sponsored by the group.

But the scale is tipping, he said. About 20% of group practices report that they have an electronic health record of some kind. In addition, 8% have a dictation and transcription system for physician notes, combined with a document imaging management system for information received on paper.

“We're seeing a steady movement toward a paperless office,” Dr. Jessee said.

The preliminary findings are based on responses from about 1,000 group practices that responded to an electronic questionnaire. The second stage of the survey will include mailing more than 16,000 printed questionnaires to a sample of group practices across the country. Complete results from the survey are expected this spring.

The survey is part of a contract from the Agency for Healthcare Research and Quality to MGMA's Center for Research and the University of Minnesota. The purpose of the contract is to provide a baseline that describes the use of new information technologies in medical groups.

Some of the challenges physicians face in making the transition to an electronic health record include knowing which product to buy, how to go about buying it, and how to implement the system, said David Brailer, M.D., national health information technology coordinator for the Department of Health and Human Services.

“Many groups stumble at every point along the way,” Dr. Brailer said.

The private industry is working to create a voluntary certification process for electronic health record products.

The American Health Information Management Association, the Healthcare Information and Management Systems Society, and the National Alliance for Health Information Technology have formed a nonprofit group—the Certification Commission for Healthcare Information Technology—that is planning to pilot a first-step certification process this summer.

Dr. Brailer also plans to explore interoperability issues. It is not enough to have every practice using an electronic health record, he said. They also have to be able to share information with other providers and institutions. HHS already has asked the industry for comments on how to design a mechanism that would allow physicians and other health care providers to share information across the health care system.

The agency is now reviewing the more than 500 responses on how to address the legal, economic, privacy, and technical concerns involved in creating an interoperable system, Dr. Brailer said.

Most group practices are still using paper medical records and charts, according to preliminary results from a survey by the Medical Group Management Association.

“Paper is still the dominant mode of data collection,” William F. Jessee, M.D., president and CEO of the Medical Group Management Association (MGMA) said in a webcast sponsored by the group.

But the scale is tipping, he said. About 20% of group practices report that they have an electronic health record of some kind. In addition, 8% have a dictation and transcription system for physician notes, combined with a document imaging management system for information received on paper.

“We're seeing a steady movement toward a paperless office,” Dr. Jessee said.

The preliminary findings are based on responses from about 1,000 group practices that responded to an electronic questionnaire. The second stage of the survey will include mailing more than 16,000 printed questionnaires to a sample of group practices across the country. Complete results from the survey are expected this spring.

The survey is part of a contract from the Agency for Healthcare Research and Quality to MGMA's Center for Research and the University of Minnesota. The purpose of the contract is to provide a baseline that describes the use of new information technologies in medical groups.

Some of the challenges physicians face in making the transition to an electronic health record include knowing which product to buy, how to go about buying it, and how to implement the system, said David Brailer, M.D., national health information technology coordinator for the Department of Health and Human Services.

“Many groups stumble at every point along the way,” Dr. Brailer said.

The private industry is working to create a voluntary certification process for electronic health record products.

The American Health Information Management Association, the Healthcare Information and Management Systems Society, and the National Alliance for Health Information Technology have formed a nonprofit group—the Certification Commission for Healthcare Information Technology—that is planning to pilot a first-step certification process this summer.

Dr. Brailer also plans to explore interoperability issues. It is not enough to have every practice using an electronic health record, he said. They also have to be able to share information with other providers and institutions. HHS already has asked the industry for comments on how to design a mechanism that would allow physicians and other health care providers to share information across the health care system.

The agency is now reviewing the more than 500 responses on how to address the legal, economic, privacy, and technical concerns involved in creating an interoperable system, Dr. Brailer said.

Fetal Pain Bill Returns

Sen. Sam Brownback (R-Kan.) has reintroduced legislation that would require abortion providers to notify women seeking abortions at 20 weeks' gestation about “substantial evidence” that the fetus can feel pain during the procedure. The “Unborn Child Pain Awareness Act” (S. 51) says that if the woman chooses to continue with the abortion after being given the information, she would be offered anesthesia for the fetus. “Unborn children can experience pain even more so than adults, as the baby has more pain receptors per square inch than at any other time in its life,” Sen. Brownback said in a statement. Sen. Brownback introduced similar legislation in the last Congress.

The State of Stem Cell Research

Some members of Congress are answering the call made by President Bush in his State of the Union address last month to agree on clear standards for the use of human embryos in research. Reps. Diana DeGette (D-Colo.) and Michael Castle (R-Del.) wrote a letter to President Bush asking him to expand federal funding for embryonic stem cell research to lines derived after Aug. 9, 2001, but only if the lines have been derived ethically. The representatives plan to introduce legislation soon proposing that embryos would only be used if they were developed for the purpose of in vitro fertilization and would otherwise be discarded. In addition, their proposal would require that there be no financial or other inducements to donate the embryos to research. In his State of the Union speech last month, President Bush praised the medical research being done at the National Institutes of Health but vowed to ensure that human embryos would not be created for experimentation or grown for body parts and that human life should never be bought and sold. “To build a culture of life, we must also ensure that scientific advances always serve human dignity, not take advantage of some lives for the benefit of others,” he said.

Prevention First Act

Senate Minority Leader Harry Reid (D-Nev.) recently introduced legislation aimed at expanding access to preventive health services that help reduce unintended pregnancies and abortions. The “Prevention First Act” (S. 20) calls for increased funding for teen pregnancy prevention and emergency contraception education. The legislation would also require private health plans to provide the same level of prescription contraception coverage as they do for other prescription drugs and services. The bill would also ensure that sexual assault victims receive accurate information about emergency contraception and are provided with EC upon request in hospital emergency departments.

Abstinence Education Funding

The Bush Administration is seeking $206 million in fiscal year 2006 to fund abstinence education activities. The request is a $39 million increase over current funding levels. The money would help “educate adolescents and parents about the health risks of early sexual activity and provide the tools needed to make healthy choices,” Health and Human Services Secretary Mike Leavitt said. Under the budget proposal, the entire $38 million increase would go toward community-based programs, which operate under the most restrictive definition of abstinence, according to the National Family Planning and Reproductive Health Association. Susanne Martinez, vice president for public policy for Planned Parenthood Federation of America calls the proposal a waste of money in a tight fiscal environment. “This is throwing money in a direction that's not very useful,” she said. Evidence shows that abstinence-only education is not as effective as comprehensive sex education, Ms. Martinez said.

New HHS Chief and Medicaid

Medicaid reform will be high on the agenda for HHS Secretary Leavitt. “Medicaid is not meeting its potential,” Mr. Leavitt, former governor of Utah and former head of the Environmental Protection Agency, said at health care congress sponsored by the Wall Street Journal and CNBC. “It's rigid, inflexible, inefficient, and, worse yet, not financially sustainable. We need to have a serious conversation about Medicaid.” Among the ideas he's considering are negotiating reductions in the prices Medicaid pays for prescription drugs and closing loopholes relating to coverage for long-term care. He also wants to stop states from manipulating Medicaid rules to increase their federal matching funds. President Bush in the meantime focused on medical liability reform and health savings accounts in his State of the Union address, asking Congress to move forward on tax credits to help low-income workers buy insurance, and on establishing community health centers in impoverished counties.

Fetal Pain Bill Returns

Sen. Sam Brownback (R-Kan.) has reintroduced legislation that would require abortion providers to notify women seeking abortions at 20 weeks' gestation about “substantial evidence” that the fetus can feel pain during the procedure. The “Unborn Child Pain Awareness Act” (S. 51) says that if the woman chooses to continue with the abortion after being given the information, she would be offered anesthesia for the fetus. “Unborn children can experience pain even more so than adults, as the baby has more pain receptors per square inch than at any other time in its life,” Sen. Brownback said in a statement. Sen. Brownback introduced similar legislation in the last Congress.

The State of Stem Cell Research

Some members of Congress are answering the call made by President Bush in his State of the Union address last month to agree on clear standards for the use of human embryos in research. Reps. Diana DeGette (D-Colo.) and Michael Castle (R-Del.) wrote a letter to President Bush asking him to expand federal funding for embryonic stem cell research to lines derived after Aug. 9, 2001, but only if the lines have been derived ethically. The representatives plan to introduce legislation soon proposing that embryos would only be used if they were developed for the purpose of in vitro fertilization and would otherwise be discarded. In addition, their proposal would require that there be no financial or other inducements to donate the embryos to research. In his State of the Union speech last month, President Bush praised the medical research being done at the National Institutes of Health but vowed to ensure that human embryos would not be created for experimentation or grown for body parts and that human life should never be bought and sold. “To build a culture of life, we must also ensure that scientific advances always serve human dignity, not take advantage of some lives for the benefit of others,” he said.

Prevention First Act

Senate Minority Leader Harry Reid (D-Nev.) recently introduced legislation aimed at expanding access to preventive health services that help reduce unintended pregnancies and abortions. The “Prevention First Act” (S. 20) calls for increased funding for teen pregnancy prevention and emergency contraception education. The legislation would also require private health plans to provide the same level of prescription contraception coverage as they do for other prescription drugs and services. The bill would also ensure that sexual assault victims receive accurate information about emergency contraception and are provided with EC upon request in hospital emergency departments.

Abstinence Education Funding

The Bush Administration is seeking $206 million in fiscal year 2006 to fund abstinence education activities. The request is a $39 million increase over current funding levels. The money would help “educate adolescents and parents about the health risks of early sexual activity and provide the tools needed to make healthy choices,” Health and Human Services Secretary Mike Leavitt said. Under the budget proposal, the entire $38 million increase would go toward community-based programs, which operate under the most restrictive definition of abstinence, according to the National Family Planning and Reproductive Health Association. Susanne Martinez, vice president for public policy for Planned Parenthood Federation of America calls the proposal a waste of money in a tight fiscal environment. “This is throwing money in a direction that's not very useful,” she said. Evidence shows that abstinence-only education is not as effective as comprehensive sex education, Ms. Martinez said.

New HHS Chief and Medicaid

Medicaid reform will be high on the agenda for HHS Secretary Leavitt. “Medicaid is not meeting its potential,” Mr. Leavitt, former governor of Utah and former head of the Environmental Protection Agency, said at health care congress sponsored by the Wall Street Journal and CNBC. “It's rigid, inflexible, inefficient, and, worse yet, not financially sustainable. We need to have a serious conversation about Medicaid.” Among the ideas he's considering are negotiating reductions in the prices Medicaid pays for prescription drugs and closing loopholes relating to coverage for long-term care. He also wants to stop states from manipulating Medicaid rules to increase their federal matching funds. President Bush in the meantime focused on medical liability reform and health savings accounts in his State of the Union address, asking Congress to move forward on tax credits to help low-income workers buy insurance, and on establishing community health centers in impoverished counties.

Fetal Pain Bill Returns

Sen. Sam Brownback (R-Kan.) has reintroduced legislation that would require abortion providers to notify women seeking abortions at 20 weeks' gestation about “substantial evidence” that the fetus can feel pain during the procedure. The “Unborn Child Pain Awareness Act” (S. 51) says that if the woman chooses to continue with the abortion after being given the information, she would be offered anesthesia for the fetus. “Unborn children can experience pain even more so than adults, as the baby has more pain receptors per square inch than at any other time in its life,” Sen. Brownback said in a statement. Sen. Brownback introduced similar legislation in the last Congress.

The State of Stem Cell Research

Some members of Congress are answering the call made by President Bush in his State of the Union address last month to agree on clear standards for the use of human embryos in research. Reps. Diana DeGette (D-Colo.) and Michael Castle (R-Del.) wrote a letter to President Bush asking him to expand federal funding for embryonic stem cell research to lines derived after Aug. 9, 2001, but only if the lines have been derived ethically. The representatives plan to introduce legislation soon proposing that embryos would only be used if they were developed for the purpose of in vitro fertilization and would otherwise be discarded. In addition, their proposal would require that there be no financial or other inducements to donate the embryos to research. In his State of the Union speech last month, President Bush praised the medical research being done at the National Institutes of Health but vowed to ensure that human embryos would not be created for experimentation or grown for body parts and that human life should never be bought and sold. “To build a culture of life, we must also ensure that scientific advances always serve human dignity, not take advantage of some lives for the benefit of others,” he said.

Prevention First Act

Senate Minority Leader Harry Reid (D-Nev.) recently introduced legislation aimed at expanding access to preventive health services that help reduce unintended pregnancies and abortions. The “Prevention First Act” (S. 20) calls for increased funding for teen pregnancy prevention and emergency contraception education. The legislation would also require private health plans to provide the same level of prescription contraception coverage as they do for other prescription drugs and services. The bill would also ensure that sexual assault victims receive accurate information about emergency contraception and are provided with EC upon request in hospital emergency departments.

Abstinence Education Funding

The Bush Administration is seeking $206 million in fiscal year 2006 to fund abstinence education activities. The request is a $39 million increase over current funding levels. The money would help “educate adolescents and parents about the health risks of early sexual activity and provide the tools needed to make healthy choices,” Health and Human Services Secretary Mike Leavitt said. Under the budget proposal, the entire $38 million increase would go toward community-based programs, which operate under the most restrictive definition of abstinence, according to the National Family Planning and Reproductive Health Association. Susanne Martinez, vice president for public policy for Planned Parenthood Federation of America calls the proposal a waste of money in a tight fiscal environment. “This is throwing money in a direction that's not very useful,” she said. Evidence shows that abstinence-only education is not as effective as comprehensive sex education, Ms. Martinez said.

New HHS Chief and Medicaid

Medicaid reform will be high on the agenda for HHS Secretary Leavitt. “Medicaid is not meeting its potential,” Mr. Leavitt, former governor of Utah and former head of the Environmental Protection Agency, said at health care congress sponsored by the Wall Street Journal and CNBC. “It's rigid, inflexible, inefficient, and, worse yet, not financially sustainable. We need to have a serious conversation about Medicaid.” Among the ideas he's considering are negotiating reductions in the prices Medicaid pays for prescription drugs and closing loopholes relating to coverage for long-term care. He also wants to stop states from manipulating Medicaid rules to increase their federal matching funds. President Bush in the meantime focused on medical liability reform and health savings accounts in his State of the Union address, asking Congress to move forward on tax credits to help low-income workers buy insurance, and on establishing community health centers in impoverished counties.

Officials at the National Institutes of Health are tightening restrictions on outside consulting arrangements with industry after more than a year of investigations turned up potential conflicts of interest.

“Nothing is more important to me than preserving the trust of the public in NIH,” Elias A. Zerhouni, M.D., NIH director, said in a statement announcing the new ethics rules. “It is unfortunate that the activities of a few employees have tainted the stellar reputation of the many thousands of NIH scientists who have never compromised their integrity and have selflessly served the nation with great distinction through their discoveries.”

The new policy bars all NIH employees from engaging in compensated or uncompensated employment or consulting relationships with those organizations that are substantially affected by NIH decisions. Such organizations include pharmaceutical manufacturers, biotechnology companies, support research institutions, health care providers and insurers, and related trade and professional associations.

The policy also prohibits NIH employees from participating in compensated teaching, speaking, writing, or editing with these affected organizations.

Further, NIH employees are prohibited from self-employment activities that involve the sale or promotion of services or products from these organizations.

However, employees are allowed to teach courses that require multiple presentations and are part of an established curriculum at a university or college. They can also teach, speak, or write as part of a continuing education program. However, if the funding for the program comes from a substantially affected organization, like a drug company, it must be funded by an unrestricted grant.

NIH employees can also author articles, chapters, and textbooks that are subject to peer review provided that funding from affected organizations are in the form of unrestricted contributions. They are also allowed to continue clinical care to individual patients.

The new regulation also takes aim at stock ownership. NIH employees who are required to file financial disclosure statements are prohibited from acquiring or holding financial interests in affected organizations including biotechnology, pharmaceutical, and medical device companies.

All other NIH employees are subject to a $15,000 cap on such holdings.

“This new policy is an extension of a profession-wide examination of physicians' relationships to industry,” said William E. Golden, M.D., professor of medicine and public health at the University of Arkansas in Little Rock.

The interim final regulation was developed by the Department of Health and Human Services with the Office of Government Ethics and went into effect immediately. Officials at HHS will continue to review the impact of the regulation and work on developing a comprehensive policy regarding outside consulting activities.

The new policy comes after about a year of internal NIH investigations as well as congressional inquiries into consulting arrangements between NIH employees and outside companies. NIH officials had previously proposed a 1-year moratorium on all outside consulting arrangements.

“Though I believe that some outside activities are in the best interest of the public when designed to accelerate the development of new discoveries, we must first have better oversight systems to ensure transparency and sound ethical practices and procedures,” Dr. Zerhouni said.

The new policy was praised by the Association of American Medical Colleges. “The rules are clear and unambiguous and will enhance the public's confidence in the integrity and dedication of NIH employees and scientists,” AAMC President Jordan J. Cohen, M.D., commented in statement.

“We also firmly support NIH's plan to assess the impact of these new rules within 1 year. Given the sweeping changes being made and the possibility of unintended consequences, it is prudent for the agency to undertake a thorough review after full implementation so that appropriate modifications can be made, if necessary,” he said.

Officials at the National Institutes of Health are tightening restrictions on outside consulting arrangements with industry after more than a year of investigations turned up potential conflicts of interest.

“Nothing is more important to me than preserving the trust of the public in NIH,” Elias A. Zerhouni, M.D., NIH director, said in a statement announcing the new ethics rules. “It is unfortunate that the activities of a few employees have tainted the stellar reputation of the many thousands of NIH scientists who have never compromised their integrity and have selflessly served the nation with great distinction through their discoveries.”

The new policy bars all NIH employees from engaging in compensated or uncompensated employment or consulting relationships with those organizations that are substantially affected by NIH decisions. Such organizations include pharmaceutical manufacturers, biotechnology companies, support research institutions, health care providers and insurers, and related trade and professional associations.

The policy also prohibits NIH employees from participating in compensated teaching, speaking, writing, or editing with these affected organizations.

Further, NIH employees are prohibited from self-employment activities that involve the sale or promotion of services or products from these organizations.

However, employees are allowed to teach courses that require multiple presentations and are part of an established curriculum at a university or college. They can also teach, speak, or write as part of a continuing education program. However, if the funding for the program comes from a substantially affected organization, like a drug company, it must be funded by an unrestricted grant.

NIH employees can also author articles, chapters, and textbooks that are subject to peer review provided that funding from affected organizations are in the form of unrestricted contributions. They are also allowed to continue clinical care to individual patients.

The new regulation also takes aim at stock ownership. NIH employees who are required to file financial disclosure statements are prohibited from acquiring or holding financial interests in affected organizations including biotechnology, pharmaceutical, and medical device companies.

All other NIH employees are subject to a $15,000 cap on such holdings.

“This new policy is an extension of a profession-wide examination of physicians' relationships to industry,” said William E. Golden, M.D., professor of medicine and public health at the University of Arkansas in Little Rock.

The interim final regulation was developed by the Department of Health and Human Services with the Office of Government Ethics and went into effect immediately. Officials at HHS will continue to review the impact of the regulation and work on developing a comprehensive policy regarding outside consulting activities.

The new policy comes after about a year of internal NIH investigations as well as congressional inquiries into consulting arrangements between NIH employees and outside companies. NIH officials had previously proposed a 1-year moratorium on all outside consulting arrangements.

“Though I believe that some outside activities are in the best interest of the public when designed to accelerate the development of new discoveries, we must first have better oversight systems to ensure transparency and sound ethical practices and procedures,” Dr. Zerhouni said.

The new policy was praised by the Association of American Medical Colleges. “The rules are clear and unambiguous and will enhance the public's confidence in the integrity and dedication of NIH employees and scientists,” AAMC President Jordan J. Cohen, M.D., commented in statement.

“We also firmly support NIH's plan to assess the impact of these new rules within 1 year. Given the sweeping changes being made and the possibility of unintended consequences, it is prudent for the agency to undertake a thorough review after full implementation so that appropriate modifications can be made, if necessary,” he said.

Officials at the National Institutes of Health are tightening restrictions on outside consulting arrangements with industry after more than a year of investigations turned up potential conflicts of interest.

“Nothing is more important to me than preserving the trust of the public in NIH,” Elias A. Zerhouni, M.D., NIH director, said in a statement announcing the new ethics rules. “It is unfortunate that the activities of a few employees have tainted the stellar reputation of the many thousands of NIH scientists who have never compromised their integrity and have selflessly served the nation with great distinction through their discoveries.”

The new policy bars all NIH employees from engaging in compensated or uncompensated employment or consulting relationships with those organizations that are substantially affected by NIH decisions. Such organizations include pharmaceutical manufacturers, biotechnology companies, support research institutions, health care providers and insurers, and related trade and professional associations.

The policy also prohibits NIH employees from participating in compensated teaching, speaking, writing, or editing with these affected organizations.

Further, NIH employees are prohibited from self-employment activities that involve the sale or promotion of services or products from these organizations.

However, employees are allowed to teach courses that require multiple presentations and are part of an established curriculum at a university or college. They can also teach, speak, or write as part of a continuing education program. However, if the funding for the program comes from a substantially affected organization, like a drug company, it must be funded by an unrestricted grant.

NIH employees can also author articles, chapters, and textbooks that are subject to peer review provided that funding from affected organizations are in the form of unrestricted contributions. They are also allowed to continue clinical care to individual patients.

The new regulation also takes aim at stock ownership. NIH employees who are required to file financial disclosure statements are prohibited from acquiring or holding financial interests in affected organizations including biotechnology, pharmaceutical, and medical device companies.

All other NIH employees are subject to a $15,000 cap on such holdings.

“This new policy is an extension of a profession-wide examination of physicians' relationships to industry,” said William E. Golden, M.D., professor of medicine and public health at the University of Arkansas in Little Rock.

The interim final regulation was developed by the Department of Health and Human Services with the Office of Government Ethics and went into effect immediately. Officials at HHS will continue to review the impact of the regulation and work on developing a comprehensive policy regarding outside consulting activities.

The new policy comes after about a year of internal NIH investigations as well as congressional inquiries into consulting arrangements between NIH employees and outside companies. NIH officials had previously proposed a 1-year moratorium on all outside consulting arrangements.

“Though I believe that some outside activities are in the best interest of the public when designed to accelerate the development of new discoveries, we must first have better oversight systems to ensure transparency and sound ethical practices and procedures,” Dr. Zerhouni said.

The new policy was praised by the Association of American Medical Colleges. “The rules are clear and unambiguous and will enhance the public's confidence in the integrity and dedication of NIH employees and scientists,” AAMC President Jordan J. Cohen, M.D., commented in statement.

“We also firmly support NIH's plan to assess the impact of these new rules within 1 year. Given the sweeping changes being made and the possibility of unintended consequences, it is prudent for the agency to undertake a thorough review after full implementation so that appropriate modifications can be made, if necessary,” he said.

A coalition of the neurovascular medical specialties has outlined a set of training and credentialing standards for performing carotid stenting that goes far beyond similar guidelines released by interventional cardiologists and vascular surgeons.

The guidelines, entitled “Training, Competency, and Credentialing Standards for Diagnostic Cervicocerebral Angiography, Carotid Stenting, and Cerebrovascular Intervention,” were developed by the American Academy of Neurology, the American Association of Neurological Surgeons, the American Society of Interventional and Therapeutic Neuroradiology, the American Society of Neuroradiology, the Congress of Neurological Surgeons, and others. They were simultaneously published in several medical journals.

These standards come at a critical time, said Anthony Furlan, M.D., a neurologist who helped develop the guidelines.

The Food and Drug Administration recently approved the Guidant Rx ACCULINK carotid stent and issued conditional approval to Cordis Corp.'s PRECISE OTW Nitinol Self-Expanding Stent.

And officials at the Centers for Medicare and Medicaid Services are poised to allow coverage for carotid stenting outside of clinical trials in patients who would be high-risk candidates for endarterectomy and who have symptomatic carotid artery stenosis of at least 70%.

“Our role here is to provide guidance to credentialing committees,” said Dr. Furlan, who serves on the American Academy of Neurology's Stroke Systems Task Force and heads the section of stroke and neurologic intensive care in the department of neurology at the Cleveland Clinic Foundation.

The new standards are also an attempt to combine the broad knowledge of the broad neurological communities, said John J. Connors III, M.D., immediate past president of the American Society of Interventional and Therapeutic Neuroradiology and director of interventional neuroradiology at Baptist Hospital of Miami.

“Due to the inherent complexity of the neurosciences, our specialties have been somewhat compartmentalized,” Dr. Connors said in an interview. “With the potential for so many different specialties to be performing carotid stenting, these standards are an opportunity to provide quality assurance based on the collective knowledge of experts in the fields of the neurological sciences.”

“Many physicians may be experts in one area, but with carotid stenting they need to have a basic fund of knowledge in addition to being masters of a variety of skills,” he said.

Importantly, a basic knowledge of the brain is required, Dr. Connors said. The neurovascular guidelines call for any physician performing cervicocerebral interventional procedures, including carotid stenting, to have had a minimum of 6 months of formal training approved by the Accreditation Council for Graduate Medical Education (ACGME) in at least one of the neurosciences—neuroradiology, neurosurgery, neurology, or vascular neurology.

In addition, before beginning postgraduate training in cervicocerebral interventional procedures, physicians must be appropriately trained in and must competently complete at least 100 diagnostic cervicocerebral angiograms. The document also recommends the creation of a defined training pathway for carotid stenting.

Under these standards, many physicians would need to engage in additional training in order to achieve competency in these procedures, Dr. Connors said.

But he noted that even these guidelines are a low bar considering that the potential adverse outcomes in carotid stenting are stroke and death.

The Neurovascular Coalition guidelines are aimed at creating a minimal standard for training in these procedures, Dr. Connors said, but they aren't aimed at locking any specialties out of the field.

However, Dr. Connors said he is concerned that guidelines developed jointly by the Society for Cardiovascular Angiography and Interventions (SCAI), the Society for Vascular Medicine and Biology, and the Society for Vascular Surgery do not require sufficient training.

For example, the guidelines released by the interventional cardiologists and vascular surgeons call for physicians to perform a minimum of 30 diagnostic carotid angiograms and 25 carotid-stenting procedures in order to attain competence in carotid stenting.

“This is exactly one-tenth of the training required for coronary artery stenting,” Dr. Connors said.

But Dr. William A. Gray, M.D., director of endovascular care at the Swedish Heart Institute in Seattle and one of the authors of the SCAI guidelines, does not agree that performing 100 angiograms is necessary to show proficiency.

In fact, he sees that requirement as a bit excessive.

“We look at this as a potential barrier to entry for otherwise qualified operators,” Dr. Gray said in an interview.

Instead, Dr. Gray said the threshold of 30 diagnostic angiograms is consistent with the experience of many cardiologists who have been working in the field for years, and with the experience of operators in the recently completed carotid stent trials.

“It reflects the qualifications of operators in these trials, which resulted in excellent outcomes,” he said.

Dr. Gray said he respects the work that went into the neurovascular document, but believes the guidelines developed by the interventional cardiologists and vascular surgeons are a better reflection of the reality of performing carotid stenting and its program development.

And interventional cardiologists have other concerns about the neurovascular guidelines.

For example, the requirement for physicians to complete 100 angiograms could lead to some unnecessary procedures, Kenneth Rosenfield, M.D., director of cardiac and vascular invasive services at Massachusetts General Hospital in Boston and an author of the SCAI guidelines, told CLINICAL NEUROLOGY NEWS.

With the need for diagnostic angiograms declining, some physicians might be inclined to perform the procedure just to satisfy the requirements for performing carotid artery stenting, he said.

Another provision in the neurovascular guidelines that calls for 6 months of ACGME-approved training in the neurosciences doesn't match up with the training of most experienced physicians who are successfully performing carotid artery stenting, Dr. Rosenfield said.

“It should not be about setting barriers,” he said. “It should be about allowing patients access to these procedures.”

And not all the criticism is coming from the cardiology side. Nick Hopkins, M.D., professor and chair of neurosurgery and professor of radiology at the State University of New York at Buffalo, said the guidelines developed by the Neurovascular Coalition lack credibility.

The problem with the guidelines, he said, is that they don't include input from those subspecialties that are performing carotid stenting.

“To make guidelines for others when you don't do it yourself just doesn't compute,” he said.

Dr. Hopkins predicts that hospital credentialing committees will adopt standards closer to those outlined by the interventional cardiologists, vascular surgeons, and vascular medicine physicians because they have the most experience in this area.

Comparing the Recommendations

A coalition of the neurovascular medical specialties has outlined a set of training and credentialing standards for performing carotid stenting that goes far beyond similar guidelines released by interventional cardiologists and vascular surgeons.

The guidelines, entitled “Training, Competency, and Credentialing Standards for Diagnostic Cervicocerebral Angiography, Carotid Stenting, and Cerebrovascular Intervention,” were developed by the American Academy of Neurology, the American Association of Neurological Surgeons, the American Society of Interventional and Therapeutic Neuroradiology, the American Society of Neuroradiology, the Congress of Neurological Surgeons, and others. They were simultaneously published in several medical journals.

These standards come at a critical time, said Anthony Furlan, M.D., a neurologist who helped develop the guidelines.

The Food and Drug Administration recently approved the Guidant Rx ACCULINK carotid stent and issued conditional approval to Cordis Corp.'s PRECISE OTW Nitinol Self-Expanding Stent.

And officials at the Centers for Medicare and Medicaid Services are poised to allow coverage for carotid stenting outside of clinical trials in patients who would be high-risk candidates for endarterectomy and who have symptomatic carotid artery stenosis of at least 70%.

“Our role here is to provide guidance to credentialing committees,” said Dr. Furlan, who serves on the American Academy of Neurology's Stroke Systems Task Force and heads the section of stroke and neurologic intensive care in the department of neurology at the Cleveland Clinic Foundation.

The new standards are also an attempt to combine the broad knowledge of the broad neurological communities, said John J. Connors III, M.D., immediate past president of the American Society of Interventional and Therapeutic Neuroradiology and director of interventional neuroradiology at Baptist Hospital of Miami.

“Due to the inherent complexity of the neurosciences, our specialties have been somewhat compartmentalized,” Dr. Connors said in an interview. “With the potential for so many different specialties to be performing carotid stenting, these standards are an opportunity to provide quality assurance based on the collective knowledge of experts in the fields of the neurological sciences.”

“Many physicians may be experts in one area, but with carotid stenting they need to have a basic fund of knowledge in addition to being masters of a variety of skills,” he said.

Importantly, a basic knowledge of the brain is required, Dr. Connors said. The neurovascular guidelines call for any physician performing cervicocerebral interventional procedures, including carotid stenting, to have had a minimum of 6 months of formal training approved by the Accreditation Council for Graduate Medical Education (ACGME) in at least one of the neurosciences—neuroradiology, neurosurgery, neurology, or vascular neurology.

In addition, before beginning postgraduate training in cervicocerebral interventional procedures, physicians must be appropriately trained in and must competently complete at least 100 diagnostic cervicocerebral angiograms. The document also recommends the creation of a defined training pathway for carotid stenting.

Under these standards, many physicians would need to engage in additional training in order to achieve competency in these procedures, Dr. Connors said.

But he noted that even these guidelines are a low bar considering that the potential adverse outcomes in carotid stenting are stroke and death.

The Neurovascular Coalition guidelines are aimed at creating a minimal standard for training in these procedures, Dr. Connors said, but they aren't aimed at locking any specialties out of the field.

However, Dr. Connors said he is concerned that guidelines developed jointly by the Society for Cardiovascular Angiography and Interventions (SCAI), the Society for Vascular Medicine and Biology, and the Society for Vascular Surgery do not require sufficient training.

For example, the guidelines released by the interventional cardiologists and vascular surgeons call for physicians to perform a minimum of 30 diagnostic carotid angiograms and 25 carotid-stenting procedures in order to attain competence in carotid stenting.

“This is exactly one-tenth of the training required for coronary artery stenting,” Dr. Connors said.

But Dr. William A. Gray, M.D., director of endovascular care at the Swedish Heart Institute in Seattle and one of the authors of the SCAI guidelines, does not agree that performing 100 angiograms is necessary to show proficiency.

In fact, he sees that requirement as a bit excessive.

“We look at this as a potential barrier to entry for otherwise qualified operators,” Dr. Gray said in an interview.

Instead, Dr. Gray said the threshold of 30 diagnostic angiograms is consistent with the experience of many cardiologists who have been working in the field for years, and with the experience of operators in the recently completed carotid stent trials.

“It reflects the qualifications of operators in these trials, which resulted in excellent outcomes,” he said.

Dr. Gray said he respects the work that went into the neurovascular document, but believes the guidelines developed by the interventional cardiologists and vascular surgeons are a better reflection of the reality of performing carotid stenting and its program development.

And interventional cardiologists have other concerns about the neurovascular guidelines.

For example, the requirement for physicians to complete 100 angiograms could lead to some unnecessary procedures, Kenneth Rosenfield, M.D., director of cardiac and vascular invasive services at Massachusetts General Hospital in Boston and an author of the SCAI guidelines, told CLINICAL NEUROLOGY NEWS.

With the need for diagnostic angiograms declining, some physicians might be inclined to perform the procedure just to satisfy the requirements for performing carotid artery stenting, he said.

Another provision in the neurovascular guidelines that calls for 6 months of ACGME-approved training in the neurosciences doesn't match up with the training of most experienced physicians who are successfully performing carotid artery stenting, Dr. Rosenfield said.

“It should not be about setting barriers,” he said. “It should be about allowing patients access to these procedures.”

And not all the criticism is coming from the cardiology side. Nick Hopkins, M.D., professor and chair of neurosurgery and professor of radiology at the State University of New York at Buffalo, said the guidelines developed by the Neurovascular Coalition lack credibility.

The problem with the guidelines, he said, is that they don't include input from those subspecialties that are performing carotid stenting.

“To make guidelines for others when you don't do it yourself just doesn't compute,” he said.

Dr. Hopkins predicts that hospital credentialing committees will adopt standards closer to those outlined by the interventional cardiologists, vascular surgeons, and vascular medicine physicians because they have the most experience in this area.

Comparing the Recommendations

A coalition of the neurovascular medical specialties has outlined a set of training and credentialing standards for performing carotid stenting that goes far beyond similar guidelines released by interventional cardiologists and vascular surgeons.

The guidelines, entitled “Training, Competency, and Credentialing Standards for Diagnostic Cervicocerebral Angiography, Carotid Stenting, and Cerebrovascular Intervention,” were developed by the American Academy of Neurology, the American Association of Neurological Surgeons, the American Society of Interventional and Therapeutic Neuroradiology, the American Society of Neuroradiology, the Congress of Neurological Surgeons, and others. They were simultaneously published in several medical journals.

These standards come at a critical time, said Anthony Furlan, M.D., a neurologist who helped develop the guidelines.

The Food and Drug Administration recently approved the Guidant Rx ACCULINK carotid stent and issued conditional approval to Cordis Corp.'s PRECISE OTW Nitinol Self-Expanding Stent.

And officials at the Centers for Medicare and Medicaid Services are poised to allow coverage for carotid stenting outside of clinical trials in patients who would be high-risk candidates for endarterectomy and who have symptomatic carotid artery stenosis of at least 70%.

“Our role here is to provide guidance to credentialing committees,” said Dr. Furlan, who serves on the American Academy of Neurology's Stroke Systems Task Force and heads the section of stroke and neurologic intensive care in the department of neurology at the Cleveland Clinic Foundation.

The new standards are also an attempt to combine the broad knowledge of the broad neurological communities, said John J. Connors III, M.D., immediate past president of the American Society of Interventional and Therapeutic Neuroradiology and director of interventional neuroradiology at Baptist Hospital of Miami.

“Due to the inherent complexity of the neurosciences, our specialties have been somewhat compartmentalized,” Dr. Connors said in an interview. “With the potential for so many different specialties to be performing carotid stenting, these standards are an opportunity to provide quality assurance based on the collective knowledge of experts in the fields of the neurological sciences.”

“Many physicians may be experts in one area, but with carotid stenting they need to have a basic fund of knowledge in addition to being masters of a variety of skills,” he said.

Importantly, a basic knowledge of the brain is required, Dr. Connors said. The neurovascular guidelines call for any physician performing cervicocerebral interventional procedures, including carotid stenting, to have had a minimum of 6 months of formal training approved by the Accreditation Council for Graduate Medical Education (ACGME) in at least one of the neurosciences—neuroradiology, neurosurgery, neurology, or vascular neurology.

In addition, before beginning postgraduate training in cervicocerebral interventional procedures, physicians must be appropriately trained in and must competently complete at least 100 diagnostic cervicocerebral angiograms. The document also recommends the creation of a defined training pathway for carotid stenting.

Under these standards, many physicians would need to engage in additional training in order to achieve competency in these procedures, Dr. Connors said.

But he noted that even these guidelines are a low bar considering that the potential adverse outcomes in carotid stenting are stroke and death.

The Neurovascular Coalition guidelines are aimed at creating a minimal standard for training in these procedures, Dr. Connors said, but they aren't aimed at locking any specialties out of the field.

However, Dr. Connors said he is concerned that guidelines developed jointly by the Society for Cardiovascular Angiography and Interventions (SCAI), the Society for Vascular Medicine and Biology, and the Society for Vascular Surgery do not require sufficient training.

For example, the guidelines released by the interventional cardiologists and vascular surgeons call for physicians to perform a minimum of 30 diagnostic carotid angiograms and 25 carotid-stenting procedures in order to attain competence in carotid stenting.

“This is exactly one-tenth of the training required for coronary artery stenting,” Dr. Connors said.

But Dr. William A. Gray, M.D., director of endovascular care at the Swedish Heart Institute in Seattle and one of the authors of the SCAI guidelines, does not agree that performing 100 angiograms is necessary to show proficiency.

In fact, he sees that requirement as a bit excessive.

“We look at this as a potential barrier to entry for otherwise qualified operators,” Dr. Gray said in an interview.

Instead, Dr. Gray said the threshold of 30 diagnostic angiograms is consistent with the experience of many cardiologists who have been working in the field for years, and with the experience of operators in the recently completed carotid stent trials.

“It reflects the qualifications of operators in these trials, which resulted in excellent outcomes,” he said.

Dr. Gray said he respects the work that went into the neurovascular document, but believes the guidelines developed by the interventional cardiologists and vascular surgeons are a better reflection of the reality of performing carotid stenting and its program development.

And interventional cardiologists have other concerns about the neurovascular guidelines.

For example, the requirement for physicians to complete 100 angiograms could lead to some unnecessary procedures, Kenneth Rosenfield, M.D., director of cardiac and vascular invasive services at Massachusetts General Hospital in Boston and an author of the SCAI guidelines, told CLINICAL NEUROLOGY NEWS.

With the need for diagnostic angiograms declining, some physicians might be inclined to perform the procedure just to satisfy the requirements for performing carotid artery stenting, he said.

Another provision in the neurovascular guidelines that calls for 6 months of ACGME-approved training in the neurosciences doesn't match up with the training of most experienced physicians who are successfully performing carotid artery stenting, Dr. Rosenfield said.

“It should not be about setting barriers,” he said. “It should be about allowing patients access to these procedures.”

And not all the criticism is coming from the cardiology side. Nick Hopkins, M.D., professor and chair of neurosurgery and professor of radiology at the State University of New York at Buffalo, said the guidelines developed by the Neurovascular Coalition lack credibility.

The problem with the guidelines, he said, is that they don't include input from those subspecialties that are performing carotid stenting.

“To make guidelines for others when you don't do it yourself just doesn't compute,” he said.

Dr. Hopkins predicts that hospital credentialing committees will adopt standards closer to those outlined by the interventional cardiologists, vascular surgeons, and vascular medicine physicians because they have the most experience in this area.

Comparing the Recommendations

Officials at the National Institutes of Health are tightening restrictions on outside consulting arrangements with industry after more than a year of investigations turned up potential conflicts of interest.

“Nothing is more important to me than preserving the trust of the public in NIH,” Elias A. Zerhouni, M.D., NIH director, said in a statement announcing the new ethics rules. “It is unfortunate that the activities of a few employees have tainted the stellar reputation of the many thousands of NIH scientists who have never compromised their integrity and have selflessly served the nation with great distinction through their discoveries.”

The new policy bars all NIH employees from engaging in compensated or uncompensated employment or consulting relationships with those organizations that are substantially affected by NIH decisions. Such organizations include pharmaceutical manufacturers, biotechnology companies, support research institutions, health care providers and insurers, and related trade and professional associations.

The policy also prohibits NIH employees from participating in compensated teaching, speaking, writing, or editing with these affected organizations, and they are prohibited from self-employment activities that involve the sale or promotion of services or products from these organizations.

However, employees are allowed to teach courses that require multiple presentations and are part of an established curriculum at a university or college. They can also teach, speak, or write as part of a continuing education program, but if the funding for the program comes from a substantially affected organization, like a drug company, it must be funded by an unrestricted grant.

NIH employees can also author articles, chapters, and textbooks that are subject to peer review provided that funding from affected organizations are in the form of unrestricted contributions, and they are allowed to continue clinical care to individual patients.

The new regulation takes aim at stock ownership. NIH employees who are required to file financial disclosure statements are prohibited from acquiring or holding financial interests in affected organizations including biotechnology, pharmaceutical, and medical device companies. All other NIH employees are subject to a $15,000 cap on such holdings.

The interim final regulation was developed by the Department of Health and Human Services with the Office of Government Ethics and went into effect immediately. Officials at HHS will continue to review the impact of the regulation and work on developing a comprehensive policy regarding outside consulting activities.

The new policy comes after about a year of internal NIH investigations as well as congressional inquiries into consulting arrangements between NIH employees and outside companies.

The new policy was praised by the Association of American Medical Colleges. “The rules are clear and unambiguous and will enhance the public's confidence in the integrity and dedication of NIH employees and scientists,” AAMC President Jordan J. Cohen, M.D., said in statement.

Officials at NIH also announced a new policy aimed at speeding the public's access to scientific articles that result from NIH-funded research. Under the policy, the agency is calling on scientists to voluntarily release manuscripts supported by NIH to the public in an online archive within a year of peer-reviewed publication.

Officials at the National Institutes of Health are tightening restrictions on outside consulting arrangements with industry after more than a year of investigations turned up potential conflicts of interest.

“Nothing is more important to me than preserving the trust of the public in NIH,” Elias A. Zerhouni, M.D., NIH director, said in a statement announcing the new ethics rules. “It is unfortunate that the activities of a few employees have tainted the stellar reputation of the many thousands of NIH scientists who have never compromised their integrity and have selflessly served the nation with great distinction through their discoveries.”

The new policy bars all NIH employees from engaging in compensated or uncompensated employment or consulting relationships with those organizations that are substantially affected by NIH decisions. Such organizations include pharmaceutical manufacturers, biotechnology companies, support research institutions, health care providers and insurers, and related trade and professional associations.

The policy also prohibits NIH employees from participating in compensated teaching, speaking, writing, or editing with these affected organizations, and they are prohibited from self-employment activities that involve the sale or promotion of services or products from these organizations.

However, employees are allowed to teach courses that require multiple presentations and are part of an established curriculum at a university or college. They can also teach, speak, or write as part of a continuing education program, but if the funding for the program comes from a substantially affected organization, like a drug company, it must be funded by an unrestricted grant.

NIH employees can also author articles, chapters, and textbooks that are subject to peer review provided that funding from affected organizations are in the form of unrestricted contributions, and they are allowed to continue clinical care to individual patients.

The new regulation takes aim at stock ownership. NIH employees who are required to file financial disclosure statements are prohibited from acquiring or holding financial interests in affected organizations including biotechnology, pharmaceutical, and medical device companies. All other NIH employees are subject to a $15,000 cap on such holdings.

The interim final regulation was developed by the Department of Health and Human Services with the Office of Government Ethics and went into effect immediately. Officials at HHS will continue to review the impact of the regulation and work on developing a comprehensive policy regarding outside consulting activities.

The new policy comes after about a year of internal NIH investigations as well as congressional inquiries into consulting arrangements between NIH employees and outside companies.

The new policy was praised by the Association of American Medical Colleges. “The rules are clear and unambiguous and will enhance the public's confidence in the integrity and dedication of NIH employees and scientists,” AAMC President Jordan J. Cohen, M.D., said in statement.

Officials at NIH also announced a new policy aimed at speeding the public's access to scientific articles that result from NIH-funded research. Under the policy, the agency is calling on scientists to voluntarily release manuscripts supported by NIH to the public in an online archive within a year of peer-reviewed publication.

Officials at the National Institutes of Health are tightening restrictions on outside consulting arrangements with industry after more than a year of investigations turned up potential conflicts of interest.

“Nothing is more important to me than preserving the trust of the public in NIH,” Elias A. Zerhouni, M.D., NIH director, said in a statement announcing the new ethics rules. “It is unfortunate that the activities of a few employees have tainted the stellar reputation of the many thousands of NIH scientists who have never compromised their integrity and have selflessly served the nation with great distinction through their discoveries.”

The new policy bars all NIH employees from engaging in compensated or uncompensated employment or consulting relationships with those organizations that are substantially affected by NIH decisions. Such organizations include pharmaceutical manufacturers, biotechnology companies, support research institutions, health care providers and insurers, and related trade and professional associations.

The policy also prohibits NIH employees from participating in compensated teaching, speaking, writing, or editing with these affected organizations, and they are prohibited from self-employment activities that involve the sale or promotion of services or products from these organizations.

However, employees are allowed to teach courses that require multiple presentations and are part of an established curriculum at a university or college. They can also teach, speak, or write as part of a continuing education program, but if the funding for the program comes from a substantially affected organization, like a drug company, it must be funded by an unrestricted grant.

NIH employees can also author articles, chapters, and textbooks that are subject to peer review provided that funding from affected organizations are in the form of unrestricted contributions, and they are allowed to continue clinical care to individual patients.

The new regulation takes aim at stock ownership. NIH employees who are required to file financial disclosure statements are prohibited from acquiring or holding financial interests in affected organizations including biotechnology, pharmaceutical, and medical device companies. All other NIH employees are subject to a $15,000 cap on such holdings.

The interim final regulation was developed by the Department of Health and Human Services with the Office of Government Ethics and went into effect immediately. Officials at HHS will continue to review the impact of the regulation and work on developing a comprehensive policy regarding outside consulting activities.

The new policy comes after about a year of internal NIH investigations as well as congressional inquiries into consulting arrangements between NIH employees and outside companies.

The new policy was praised by the Association of American Medical Colleges. “The rules are clear and unambiguous and will enhance the public's confidence in the integrity and dedication of NIH employees and scientists,” AAMC President Jordan J. Cohen, M.D., said in statement.

Officials at NIH also announced a new policy aimed at speeding the public's access to scientific articles that result from NIH-funded research. Under the policy, the agency is calling on scientists to voluntarily release manuscripts supported by NIH to the public in an online archive within a year of peer-reviewed publication.

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

“It's right in the lap of every physician,” said Dr. Schwartzberg, director of aging and community health at the American Medical Association. “Physicians can't say it's someone else's problem.”

Using simple language, distributing patient education materials, speaking slowly, reading instructions aloud, using teach-back techniques, and drawing pictures are some of the ways health care providers say they are trying to do a better job of reaching out to patients with low health literacy, Dr. Schwartzberg said.

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

Preliminary results show that after the training, a majority of the physicians changed their communication with patients.

For example, many reported that they were more often asking patients to repeat back instructions.

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

In examining the interactions between physicians and patients with type 2 diabetes, Dr. Schillinger found that physicians used a lot of medical jargon when providing recommendations or education to patients. Patients with low health literacy were confused by terms that physicians might expect a person with chronic diabetes to know, such as “glucometer,” or by hearing that their weight is “stable.”

But simply raising awareness may not be enough, Dr. Schillinger said. Physicians say they need more systematic support, such as appropriate educational materials.

And more research is still needed on what interventions work, especially if the medical community is going to ask insurers and other payers to offer financial incentives in this area, said David Kindig, M.D., chair of the Institute of Medicine Committee on Health Literacy.

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

“It's right in the lap of every physician,” said Dr. Schwartzberg, director of aging and community health at the American Medical Association. “Physicians can't say it's someone else's problem.”

Using simple language, distributing patient education materials, speaking slowly, reading instructions aloud, using teach-back techniques, and drawing pictures are some of the ways health care providers say they are trying to do a better job of reaching out to patients with low health literacy, Dr. Schwartzberg said.

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

Preliminary results show that after the training, a majority of the physicians changed their communication with patients.

For example, many reported that they were more often asking patients to repeat back instructions.

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

In examining the interactions between physicians and patients with type 2 diabetes, Dr. Schillinger found that physicians used a lot of medical jargon when providing recommendations or education to patients. Patients with low health literacy were confused by terms that physicians might expect a person with chronic diabetes to know, such as “glucometer,” or by hearing that their weight is “stable.”

But simply raising awareness may not be enough, Dr. Schillinger said. Physicians say they need more systematic support, such as appropriate educational materials.

And more research is still needed on what interventions work, especially if the medical community is going to ask insurers and other payers to offer financial incentives in this area, said David Kindig, M.D., chair of the Institute of Medicine Committee on Health Literacy.

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

“It's right in the lap of every physician,” said Dr. Schwartzberg, director of aging and community health at the American Medical Association. “Physicians can't say it's someone else's problem.”

Using simple language, distributing patient education materials, speaking slowly, reading instructions aloud, using teach-back techniques, and drawing pictures are some of the ways health care providers say they are trying to do a better job of reaching out to patients with low health literacy, Dr. Schwartzberg said.

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

Preliminary results show that after the training, a majority of the physicians changed their communication with patients.

For example, many reported that they were more often asking patients to repeat back instructions.

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

In examining the interactions between physicians and patients with type 2 diabetes, Dr. Schillinger found that physicians used a lot of medical jargon when providing recommendations or education to patients. Patients with low health literacy were confused by terms that physicians might expect a person with chronic diabetes to know, such as “glucometer,” or by hearing that their weight is “stable.”

But simply raising awareness may not be enough, Dr. Schillinger said. Physicians say they need more systematic support, such as appropriate educational materials.

And more research is still needed on what interventions work, especially if the medical community is going to ask insurers and other payers to offer financial incentives in this area, said David Kindig, M.D., chair of the Institute of Medicine Committee on Health Literacy.

Lupus Research Grants

With funding at the National Institutes of Health expected to be tight, officials at the Lupus Research Institute (LRI) are taking matters into their own hands. LRI is raising its individual novel research grant awards from $225,000 to $300,000 this year. The group is seeking proposals for projects that deal with less-investigated aspects of lupus along with applications from investigators working in the lupus area for the first time. LRI is also reaching out to specialties, such as cardiology, nephrology, neurology, and dermatology, to urge investigators to get involved in lupus research. “With the LRI's increased funding level, we expect the program to attract an even larger number of promising applications,” Mark Shlomchik, M.D., novel research cochairman and a professor at Yale University, New Haven, said in a statement. “By appealing to researchers in other specialties, the LRI will spur novel approaches and collaborations not previously applied to the lupus field.” The 2005 grant application deadline is June 30, 2005. For more information on the program, visit

www.lupusresearchinstitute.org

Psoriasis Advocacy

A newly formed advocacy group is calling on Congress to increase federal research for psoriasis and psoriatic arthritis. “Psoriasis Cure Now!” aims to educate lawmakers, opinion leaders, and the general public about the need for more research and the importance of patient access to the full range of treatments for the disease. Michael Paranzino, a psoriasis patient for more than 20 years, launched the group. “Congress will be disturbed to learn that for a full decade, 6.5 million of its constituents with psoriasis and psoriatic arthritis have been shortchanged in federally funded research,” Mr. Paranzino said in a statement. “It is unconscionable that psoriasis research has languished throughout the biggest increase in biomedical research funding in world history.” Psoriasis research at the National Institute of Arthritis and Musculoskeletal and Skin Diseases has declined from $4.7 million in 1995 to $4.1 million in 2004, even as funding for other diseases has increased, according to the group. The group launched a Web-based petition to Congress that is available online at

www.psorcurenow.org

NIAMS Seeks Scientific Director

The National Institute of Arthritis and Musculoskeletal and Skin Diseases has started searching for its next scientific director for its intramural research program. The NIAMS program is responsible for conducting clinical and laboratory research in arthritis and musculoskeletal and skin diseases. Researchers in the program also conduct basic research in biochemistry, immunology, pathology, histochemistry, chemistry, molecular biology, structural biology, and pharmacology. The scientific director is the principal adviser to the director of NIAMS and is responsible for program planning, budget and policy formulation, and resource allocation in the intramural program. According to NIAMS, the ideal candidate will have “demonstrated scientific leadership and research experience in both a basic and clinical research program of national and international standing in an area relevant to arthritis and other rheumatic diseases, musculoskeletal diseases, and/or skin diseases.” Applicants must have an MD and/or a PhD degree or equivalent degree, in a biomedical or related field. The deadline for applications is April 29, 2005. For information on how to apply visit

www.nih.gov/niams

Get Sick, Go Bankrupt

It doesn't pay to get sick: Medical problems contributed to about half of all bankruptcies involving 700,000 households in 2001, according to a study that was published as a Web-exclusive article by the journal Health Affairs. More than 2 million people are directly affected by medical bankruptcies annually. “When medical debts and lost income from illnesses leave families facing a mountain of bills, bankruptcy is their last chance to stop the collection calls and try to put their lives back on track,” said study coauthor Elizabeth Warren, the Leo Gottlieb Professor of Law at Harvard University, Boston. Most who have been bankrupted by medical problems had health insurance. Among those with private insurance, one-third had lost coverage at least temporarily by the time they filed for bankruptcy. The researchers obtained their information by surveying 1,771 bankruptcy filers and reviewing their court records.

New HHS Chief and Medicaid

Medicaid reform will be high on the agenda for new Health and Human Services Secretary Mike Leavitt. “Medicaid is not meeting its potential,” Mr. Leavitt, former governor of Utah and former head of the Environmental Protection Agency, said at a health care congress sponsored by the Wall Street Journal and CNBC. “It's rigid, inflexible; inefficient; and, worse yet, not financially sustainable. We need to have a serious conversation about Medicaid.” Among the ideas he's considering are negotiating reductions in the prices Medicaid pays for prescription drugs and closing loopholes relating to coverage for long-term care. He also wants to stop states from manipulating Medicaid rules to increase their federal matching funds. President Bush in the meantime focused on medical liability reform and health savings accounts in his State of the Union address, asking Congress to move forward on tax credits to help low-income workers buy insurance, and on establishing community health centers in impoverished counties.

Lupus Research Grants

With funding at the National Institutes of Health expected to be tight, officials at the Lupus Research Institute (LRI) are taking matters into their own hands. LRI is raising its individual novel research grant awards from $225,000 to $300,000 this year. The group is seeking proposals for projects that deal with less-investigated aspects of lupus along with applications from investigators working in the lupus area for the first time. LRI is also reaching out to specialties, such as cardiology, nephrology, neurology, and dermatology, to urge investigators to get involved in lupus research. “With the LRI's increased funding level, we expect the program to attract an even larger number of promising applications,” Mark Shlomchik, M.D., novel research cochairman and a professor at Yale University, New Haven, said in a statement. “By appealing to researchers in other specialties, the LRI will spur novel approaches and collaborations not previously applied to the lupus field.” The 2005 grant application deadline is June 30, 2005. For more information on the program, visit

www.lupusresearchinstitute.org

Psoriasis Advocacy

A newly formed advocacy group is calling on Congress to increase federal research for psoriasis and psoriatic arthritis. “Psoriasis Cure Now!” aims to educate lawmakers, opinion leaders, and the general public about the need for more research and the importance of patient access to the full range of treatments for the disease. Michael Paranzino, a psoriasis patient for more than 20 years, launched the group. “Congress will be disturbed to learn that for a full decade, 6.5 million of its constituents with psoriasis and psoriatic arthritis have been shortchanged in federally funded research,” Mr. Paranzino said in a statement. “It is unconscionable that psoriasis research has languished throughout the biggest increase in biomedical research funding in world history.” Psoriasis research at the National Institute of Arthritis and Musculoskeletal and Skin Diseases has declined from $4.7 million in 1995 to $4.1 million in 2004, even as funding for other diseases has increased, according to the group. The group launched a Web-based petition to Congress that is available online at

www.psorcurenow.org

NIAMS Seeks Scientific Director

The National Institute of Arthritis and Musculoskeletal and Skin Diseases has started searching for its next scientific director for its intramural research program. The NIAMS program is responsible for conducting clinical and laboratory research in arthritis and musculoskeletal and skin diseases. Researchers in the program also conduct basic research in biochemistry, immunology, pathology, histochemistry, chemistry, molecular biology, structural biology, and pharmacology. The scientific director is the principal adviser to the director of NIAMS and is responsible for program planning, budget and policy formulation, and resource allocation in the intramural program. According to NIAMS, the ideal candidate will have “demonstrated scientific leadership and research experience in both a basic and clinical research program of national and international standing in an area relevant to arthritis and other rheumatic diseases, musculoskeletal diseases, and/or skin diseases.” Applicants must have an MD and/or a PhD degree or equivalent degree, in a biomedical or related field. The deadline for applications is April 29, 2005. For information on how to apply visit

www.nih.gov/niams

Get Sick, Go Bankrupt

It doesn't pay to get sick: Medical problems contributed to about half of all bankruptcies involving 700,000 households in 2001, according to a study that was published as a Web-exclusive article by the journal Health Affairs. More than 2 million people are directly affected by medical bankruptcies annually. “When medical debts and lost income from illnesses leave families facing a mountain of bills, bankruptcy is their last chance to stop the collection calls and try to put their lives back on track,” said study coauthor Elizabeth Warren, the Leo Gottlieb Professor of Law at Harvard University, Boston. Most who have been bankrupted by medical problems had health insurance. Among those with private insurance, one-third had lost coverage at least temporarily by the time they filed for bankruptcy. The researchers obtained their information by surveying 1,771 bankruptcy filers and reviewing their court records.

New HHS Chief and Medicaid

Medicaid reform will be high on the agenda for new Health and Human Services Secretary Mike Leavitt. “Medicaid is not meeting its potential,” Mr. Leavitt, former governor of Utah and former head of the Environmental Protection Agency, said at a health care congress sponsored by the Wall Street Journal and CNBC. “It's rigid, inflexible; inefficient; and, worse yet, not financially sustainable. We need to have a serious conversation about Medicaid.” Among the ideas he's considering are negotiating reductions in the prices Medicaid pays for prescription drugs and closing loopholes relating to coverage for long-term care. He also wants to stop states from manipulating Medicaid rules to increase their federal matching funds. President Bush in the meantime focused on medical liability reform and health savings accounts in his State of the Union address, asking Congress to move forward on tax credits to help low-income workers buy insurance, and on establishing community health centers in impoverished counties.

Lupus Research Grants

With funding at the National Institutes of Health expected to be tight, officials at the Lupus Research Institute (LRI) are taking matters into their own hands. LRI is raising its individual novel research grant awards from $225,000 to $300,000 this year. The group is seeking proposals for projects that deal with less-investigated aspects of lupus along with applications from investigators working in the lupus area for the first time. LRI is also reaching out to specialties, such as cardiology, nephrology, neurology, and dermatology, to urge investigators to get involved in lupus research. “With the LRI's increased funding level, we expect the program to attract an even larger number of promising applications,” Mark Shlomchik, M.D., novel research cochairman and a professor at Yale University, New Haven, said in a statement. “By appealing to researchers in other specialties, the LRI will spur novel approaches and collaborations not previously applied to the lupus field.” The 2005 grant application deadline is June 30, 2005. For more information on the program, visit

www.lupusresearchinstitute.org

Psoriasis Advocacy

A newly formed advocacy group is calling on Congress to increase federal research for psoriasis and psoriatic arthritis. “Psoriasis Cure Now!” aims to educate lawmakers, opinion leaders, and the general public about the need for more research and the importance of patient access to the full range of treatments for the disease. Michael Paranzino, a psoriasis patient for more than 20 years, launched the group. “Congress will be disturbed to learn that for a full decade, 6.5 million of its constituents with psoriasis and psoriatic arthritis have been shortchanged in federally funded research,” Mr. Paranzino said in a statement. “It is unconscionable that psoriasis research has languished throughout the biggest increase in biomedical research funding in world history.” Psoriasis research at the National Institute of Arthritis and Musculoskeletal and Skin Diseases has declined from $4.7 million in 1995 to $4.1 million in 2004, even as funding for other diseases has increased, according to the group. The group launched a Web-based petition to Congress that is available online at

www.psorcurenow.org

NIAMS Seeks Scientific Director

The National Institute of Arthritis and Musculoskeletal and Skin Diseases has started searching for its next scientific director for its intramural research program. The NIAMS program is responsible for conducting clinical and laboratory research in arthritis and musculoskeletal and skin diseases. Researchers in the program also conduct basic research in biochemistry, immunology, pathology, histochemistry, chemistry, molecular biology, structural biology, and pharmacology. The scientific director is the principal adviser to the director of NIAMS and is responsible for program planning, budget and policy formulation, and resource allocation in the intramural program. According to NIAMS, the ideal candidate will have “demonstrated scientific leadership and research experience in both a basic and clinical research program of national and international standing in an area relevant to arthritis and other rheumatic diseases, musculoskeletal diseases, and/or skin diseases.” Applicants must have an MD and/or a PhD degree or equivalent degree, in a biomedical or related field. The deadline for applications is April 29, 2005. For information on how to apply visit

www.nih.gov/niams

Get Sick, Go Bankrupt

It doesn't pay to get sick: Medical problems contributed to about half of all bankruptcies involving 700,000 households in 2001, according to a study that was published as a Web-exclusive article by the journal Health Affairs. More than 2 million people are directly affected by medical bankruptcies annually. “When medical debts and lost income from illnesses leave families facing a mountain of bills, bankruptcy is their last chance to stop the collection calls and try to put their lives back on track,” said study coauthor Elizabeth Warren, the Leo Gottlieb Professor of Law at Harvard University, Boston. Most who have been bankrupted by medical problems had health insurance. Among those with private insurance, one-third had lost coverage at least temporarily by the time they filed for bankruptcy. The researchers obtained their information by surveying 1,771 bankruptcy filers and reviewing their court records.

New HHS Chief and Medicaid

Medicaid reform will be high on the agenda for new Health and Human Services Secretary Mike Leavitt. “Medicaid is not meeting its potential,” Mr. Leavitt, former governor of Utah and former head of the Environmental Protection Agency, said at a health care congress sponsored by the Wall Street Journal and CNBC. “It's rigid, inflexible; inefficient; and, worse yet, not financially sustainable. We need to have a serious conversation about Medicaid.” Among the ideas he's considering are negotiating reductions in the prices Medicaid pays for prescription drugs and closing loopholes relating to coverage for long-term care. He also wants to stop states from manipulating Medicaid rules to increase their federal matching funds. President Bush in the meantime focused on medical liability reform and health savings accounts in his State of the Union address, asking Congress to move forward on tax credits to help low-income workers buy insurance, and on establishing community health centers in impoverished counties.

Treatment Differences

Heart failure patients who are treated by noncardiologists are less likely to receive key medications including ACE inhibitors, ?-blockers, and aldosterone antagonists, according to a study published in the American Journal of Health-System Pharmacy (2005;62:168-72). For example, ACE inhibitors were prescribed for 61% of heart failure patients upon discharge from the hospital by cardiologists vs. 35% by noncardiologists. The study also found that cardiologists are more likely to admit a heart failure patient to the ICU and to order diagnostic tests without significantly increasing a patient's length of stay.

Revising Practice Expenses

Changing the way Medicare pays cardiothoracic surgeons is a complex issue that will require more data to solve, according to a recent analysis for the Medicare Payment Advisory Commission (MedPAC). Under the Medicare Modernization Act of 2003, Congress charged MedPAC with conducting a study of the practice expense relative values for physicians in thoracic and cardiac surgery to determine whether the values adequately account for physician costs in providing staff to hospitals. MedPAC analysts found that some physicians have their costs offset either because their staff can bill Medicare or because the hospital will pay to bring in the additional staff. However, some physicians are not reimbursed by either source. MedPAC concluded that the current system of excluding the costs of clinical staff brought to the hospital from the practice expense relative value units (RVUs) will need to be reviewed using new data being developed for an upcoming update of practice expense RVUs. “Data that enable the appropriate calculation of clinical staff expenses both in the physician's office and in the hospital … should be a priority,” the MedPAC's report to Congress said.

MedPAC: Give Doctors a 2.7% Hike

Medicare should increase physician payments by 2.7% in 2006 to keep pace with the cost of providing care, MedPAC has recommended. Such an increase will help physicians continue to treat Medicare patients, John C. Nelson, M.D., president of the American Medical Association, said in a statement. “Unless Medicare payments keep up with the cost of providing care, there is a real concern that some physicians will be forced to stop taking new Medicare patients,” he said. However, unless Congress fixes a flaw in Medicare's physician payment formula, doctors face a 5% cut next year and cumulative cuts of 30% thru 2012. Several MedPAC commissioners supported the idea of taking outpatient or Part B drugs from the formula, although the Government Accountability Office has warned that this solution would not prevent several years of declines in physician payments.

A Level Playing Field for Hospitals

The Bush administration plans to refine the inpatient hospital payment system “to ensure a more level playing field between specialty and nonspecialty hospitals,” the president announced in his fiscal year 2006 budget request for the Department of Health and Human Services. The Medicare Payment Advisory Commission has reported that specialty hospitals tend to treat relatively lower-severity patients within them, and lower shares of Medicaid patients. Yet, “it's unclear what the effect of these specialty hospitals will be,” Aaron Krupp, senior counsel with the Medical Group Management Association, said. “One thing MedPAC didn't look at was the quality of services for specialty versus regular hospitals. That angle would be informative,” said Mr. Krupp, whose organization supports a free market system. “We are going to have a lot more to say on specialty hospitals in the coming months,” when HHS releases its own report, Mark McClellan, M.D., administrator of the Centers for Medicare and Medicaid Services, recently informed reporters.

New HHS Chief and Medicaid

Medicaid reform will be high on the agenda for new HHS Secretary Mike Leavitt. “Medicaid is not meeting its potential,” Mr. Leavitt, former governor of Utah and former head of the Environmental Protection Agency, said at a health care congress sponsored by the Wall Street Journal and CNBC. “It's rigid; inflexible; inefficient; and, worse yet, not financially sustainable. We need to have a serious conversation about Medicaid.” Among the ideas he's considering are negotiating reductions in the prices Medicaid pays for prescription drugs, closing loopholes relating to coverage for long-term care, and stopping states from manipulating Medicaid rules to increase their federal matching funds. President Bush in the meantime focused on medical liability reform and health savings accounts in his State of the Union address, asking Congress to act on tax credits to help low-income workers buy insurance, and on establishing community health centers in impoverished counties.

Treatment Differences

Heart failure patients who are treated by noncardiologists are less likely to receive key medications including ACE inhibitors, ?-blockers, and aldosterone antagonists, according to a study published in the American Journal of Health-System Pharmacy (2005;62:168-72). For example, ACE inhibitors were prescribed for 61% of heart failure patients upon discharge from the hospital by cardiologists vs. 35% by noncardiologists. The study also found that cardiologists are more likely to admit a heart failure patient to the ICU and to order diagnostic tests without significantly increasing a patient's length of stay.

Revising Practice Expenses

Changing the way Medicare pays cardiothoracic surgeons is a complex issue that will require more data to solve, according to a recent analysis for the Medicare Payment Advisory Commission (MedPAC). Under the Medicare Modernization Act of 2003, Congress charged MedPAC with conducting a study of the practice expense relative values for physicians in thoracic and cardiac surgery to determine whether the values adequately account for physician costs in providing staff to hospitals. MedPAC analysts found that some physicians have their costs offset either because their staff can bill Medicare or because the hospital will pay to bring in the additional staff. However, some physicians are not reimbursed by either source. MedPAC concluded that the current system of excluding the costs of clinical staff brought to the hospital from the practice expense relative value units (RVUs) will need to be reviewed using new data being developed for an upcoming update of practice expense RVUs. “Data that enable the appropriate calculation of clinical staff expenses both in the physician's office and in the hospital … should be a priority,” the MedPAC's report to Congress said.

MedPAC: Give Doctors a 2.7% Hike

Medicare should increase physician payments by 2.7% in 2006 to keep pace with the cost of providing care, MedPAC has recommended. Such an increase will help physicians continue to treat Medicare patients, John C. Nelson, M.D., president of the American Medical Association, said in a statement. “Unless Medicare payments keep up with the cost of providing care, there is a real concern that some physicians will be forced to stop taking new Medicare patients,” he said. However, unless Congress fixes a flaw in Medicare's physician payment formula, doctors face a 5% cut next year and cumulative cuts of 30% thru 2012. Several MedPAC commissioners supported the idea of taking outpatient or Part B drugs from the formula, although the Government Accountability Office has warned that this solution would not prevent several years of declines in physician payments.

A Level Playing Field for Hospitals

The Bush administration plans to refine the inpatient hospital payment system “to ensure a more level playing field between specialty and nonspecialty hospitals,” the president announced in his fiscal year 2006 budget request for the Department of Health and Human Services. The Medicare Payment Advisory Commission has reported that specialty hospitals tend to treat relatively lower-severity patients within them, and lower shares of Medicaid patients. Yet, “it's unclear what the effect of these specialty hospitals will be,” Aaron Krupp, senior counsel with the Medical Group Management Association, said. “One thing MedPAC didn't look at was the quality of services for specialty versus regular hospitals. That angle would be informative,” said Mr. Krupp, whose organization supports a free market system. “We are going to have a lot more to say on specialty hospitals in the coming months,” when HHS releases its own report, Mark McClellan, M.D., administrator of the Centers for Medicare and Medicaid Services, recently informed reporters.

New HHS Chief and Medicaid

Medicaid reform will be high on the agenda for new HHS Secretary Mike Leavitt. “Medicaid is not meeting its potential,” Mr. Leavitt, former governor of Utah and former head of the Environmental Protection Agency, said at a health care congress sponsored by the Wall Street Journal and CNBC. “It's rigid; inflexible; inefficient; and, worse yet, not financially sustainable. We need to have a serious conversation about Medicaid.” Among the ideas he's considering are negotiating reductions in the prices Medicaid pays for prescription drugs, closing loopholes relating to coverage for long-term care, and stopping states from manipulating Medicaid rules to increase their federal matching funds. President Bush in the meantime focused on medical liability reform and health savings accounts in his State of the Union address, asking Congress to act on tax credits to help low-income workers buy insurance, and on establishing community health centers in impoverished counties.

Treatment Differences

Heart failure patients who are treated by noncardiologists are less likely to receive key medications including ACE inhibitors, ?-blockers, and aldosterone antagonists, according to a study published in the American Journal of Health-System Pharmacy (2005;62:168-72). For example, ACE inhibitors were prescribed for 61% of heart failure patients upon discharge from the hospital by cardiologists vs. 35% by noncardiologists. The study also found that cardiologists are more likely to admit a heart failure patient to the ICU and to order diagnostic tests without significantly increasing a patient's length of stay.

Revising Practice Expenses

Changing the way Medicare pays cardiothoracic surgeons is a complex issue that will require more data to solve, according to a recent analysis for the Medicare Payment Advisory Commission (MedPAC). Under the Medicare Modernization Act of 2003, Congress charged MedPAC with conducting a study of the practice expense relative values for physicians in thoracic and cardiac surgery to determine whether the values adequately account for physician costs in providing staff to hospitals. MedPAC analysts found that some physicians have their costs offset either because their staff can bill Medicare or because the hospital will pay to bring in the additional staff. However, some physicians are not reimbursed by either source. MedPAC concluded that the current system of excluding the costs of clinical staff brought to the hospital from the practice expense relative value units (RVUs) will need to be reviewed using new data being developed for an upcoming update of practice expense RVUs. “Data that enable the appropriate calculation of clinical staff expenses both in the physician's office and in the hospital … should be a priority,” the MedPAC's report to Congress said.

MedPAC: Give Doctors a 2.7% Hike

Medicare should increase physician payments by 2.7% in 2006 to keep pace with the cost of providing care, MedPAC has recommended. Such an increase will help physicians continue to treat Medicare patients, John C. Nelson, M.D., president of the American Medical Association, said in a statement. “Unless Medicare payments keep up with the cost of providing care, there is a real concern that some physicians will be forced to stop taking new Medicare patients,” he said. However, unless Congress fixes a flaw in Medicare's physician payment formula, doctors face a 5% cut next year and cumulative cuts of 30% thru 2012. Several MedPAC commissioners supported the idea of taking outpatient or Part B drugs from the formula, although the Government Accountability Office has warned that this solution would not prevent several years of declines in physician payments.

A Level Playing Field for Hospitals

The Bush administration plans to refine the inpatient hospital payment system “to ensure a more level playing field between specialty and nonspecialty hospitals,” the president announced in his fiscal year 2006 budget request for the Department of Health and Human Services. The Medicare Payment Advisory Commission has reported that specialty hospitals tend to treat relatively lower-severity patients within them, and lower shares of Medicaid patients. Yet, “it's unclear what the effect of these specialty hospitals will be,” Aaron Krupp, senior counsel with the Medical Group Management Association, said. “One thing MedPAC didn't look at was the quality of services for specialty versus regular hospitals. That angle would be informative,” said Mr. Krupp, whose organization supports a free market system. “We are going to have a lot more to say on specialty hospitals in the coming months,” when HHS releases its own report, Mark McClellan, M.D., administrator of the Centers for Medicare and Medicaid Services, recently informed reporters.

New HHS Chief and Medicaid

Medicaid reform will be high on the agenda for new HHS Secretary Mike Leavitt. “Medicaid is not meeting its potential,” Mr. Leavitt, former governor of Utah and former head of the Environmental Protection Agency, said at a health care congress sponsored by the Wall Street Journal and CNBC. “It's rigid; inflexible; inefficient; and, worse yet, not financially sustainable. We need to have a serious conversation about Medicaid.” Among the ideas he's considering are negotiating reductions in the prices Medicaid pays for prescription drugs, closing loopholes relating to coverage for long-term care, and stopping states from manipulating Medicaid rules to increase their federal matching funds. President Bush in the meantime focused on medical liability reform and health savings accounts in his State of the Union address, asking Congress to act on tax credits to help low-income workers buy insurance, and on establishing community health centers in impoverished counties.