Mary Ellen Schneider

Grant Funds Focus on Women

The Women's Health Career Development Award is being offered for the first time in 2006 by the Dermatology Foundation. This grant funds research into a range of disorders that primarily affect women, from lupus and scleroderma to the effects of hormones and environmental factors on the skin. The grant provides a $55,000 annual stipend effective July 1, 2006. Applications for the grant are due Oct. 17. The grant is open to both men and women. Details are available online at

www.dermatologyfoundation.org

www.womensderm.org

Assessing Plastic Surgery

About 85% of participants in a telephone survey who said they had considered plastic surgery reported that the benefits far outweighed the risks, according to a study published in the Sept. 1 issue of Plastic and Reconstructive Surgery. The results are based on 60 in-depth telephone interviews with individuals actively considering plastic surgery. The researchers also conducted an online survey of 644 individuals who reported actively considering surgery. Interviewees said they thought they could minimize their risks by researching the procedure and the surgeons who specialize in that area. Two-thirds of the interview participants said the potential risks would not deter them from seeking surgery, while one-third said they would need to weigh the risks and benefits carefully. The research was funded by the American Society of Plastic Surgeons.

Walter Reed to Close

Walter Reed Army Medical Center in Washington, which has cared for hundreds of thousands of soldiers and dignitaries for the past 96 years, is slated to close as part of the base realignment and closure process. The medical center was tapped by the Department of Defense to be closed and that recommendation was recently approved by members of the Defense Base Realignment and Closure Commission. The commission sent its final report to President Bush on Sept. 8. If the president agrees with the recommendations, he will send the entire list to Congress for a vote. Congress must accept or reject the list in full, but cannot amend it. If the closure is approved, most of the staff and services from the army hospital will be combined with services at the National Naval Medical Center in Bethesda, Md., and renamed the Walter Reed National Military Medical Center. Other services will be moved to Fort Belvoir, Va. Closures and realignments must begin within 2 years of congressional approval and must be completed within 6 years, according to the base realignment and closure statute.

Census Finds Rise in Uninsured

The Census Bureau reports that 45.8 million Americans were without health insurance in 2004, up from 45 million in 2003. While the increase is statistically small, it means that "an additional 860,000 Americans live without the safety net of health insurance," J. Edward Hill, M.D., president of the American Medical Association, said in a statement. "As the decrease in employment-based health insurance continues, the AMA renews its call for health insurance solutions that put patients in the driver's seat, along with their physicians," Dr. Hill said. Some of these solutions may include refundable tax credits inversely related to income and individually selected and owned health insurance, he said. In other statistics, the number of people with health insurance increased by 2 million to 245.3 million between 2003 and 2004. Those covered by government health insurance rose from 76.8 million in 2003 to 79 million—driven by increases in the percentage and number of people covered by Medicaid.

Seniors Split on Drug Benefit

Patients' optimism about Medicare's new prescription drug benefit has improved over the last few months, although beneficiaries remain split on their support, an August poll conducted by the Kaiser Family Foundation indicated. About one in three (32%) seniors have a favorable impression of the benefit and an equal amount (32%) have a negative one. In April, only one in five (21%) said they had a favorable impression. Comprehension of the benefit has improved: Overall, 37% of seniors now say they understand the new benefit "very" or "somewhat" well, which is up from 29% in April. Six in 10 seniors (60%) say they don't understand the benefit well or at all. The poll represented 1,205 adults 18 years and older, including 300 respondents 65 and older, interviewed by telephone by Princeton Survey Research Associates, on behalf of Kaiser.

Chronic Care Projects Launched

Medicare is launching chronic care pilot projects this year aimed at improving care for people with heart failure and diabetes. The program, called Medicare Health Support, will provide free, voluntary services to about 160,000 Medicare fee-for-service beneficiaries for 3 years. Participating patients will get access to nurse coaches, reminders about preventive care needs, prescription drug counseling, home visits and intensive care management when needed, and home monitoring equipment to track health status. At press time, eight areas had been selected for the program: Maryland, Oklahoma, Western Pennsylvania, Mississippi, Northwest Georgia, Chicago, Central Florida, and Washington, D.C.

Grant Funds Focus on Women

The Women's Health Career Development Award is being offered for the first time in 2006 by the Dermatology Foundation. This grant funds research into a range of disorders that primarily affect women, from lupus and scleroderma to the effects of hormones and environmental factors on the skin. The grant provides a $55,000 annual stipend effective July 1, 2006. Applications for the grant are due Oct. 17. The grant is open to both men and women. Details are available online at

www.dermatologyfoundation.org

www.womensderm.org

Assessing Plastic Surgery

About 85% of participants in a telephone survey who said they had considered plastic surgery reported that the benefits far outweighed the risks, according to a study published in the Sept. 1 issue of Plastic and Reconstructive Surgery. The results are based on 60 in-depth telephone interviews with individuals actively considering plastic surgery. The researchers also conducted an online survey of 644 individuals who reported actively considering surgery. Interviewees said they thought they could minimize their risks by researching the procedure and the surgeons who specialize in that area. Two-thirds of the interview participants said the potential risks would not deter them from seeking surgery, while one-third said they would need to weigh the risks and benefits carefully. The research was funded by the American Society of Plastic Surgeons.

Walter Reed to Close

Walter Reed Army Medical Center in Washington, which has cared for hundreds of thousands of soldiers and dignitaries for the past 96 years, is slated to close as part of the base realignment and closure process. The medical center was tapped by the Department of Defense to be closed and that recommendation was recently approved by members of the Defense Base Realignment and Closure Commission. The commission sent its final report to President Bush on Sept. 8. If the president agrees with the recommendations, he will send the entire list to Congress for a vote. Congress must accept or reject the list in full, but cannot amend it. If the closure is approved, most of the staff and services from the army hospital will be combined with services at the National Naval Medical Center in Bethesda, Md., and renamed the Walter Reed National Military Medical Center. Other services will be moved to Fort Belvoir, Va. Closures and realignments must begin within 2 years of congressional approval and must be completed within 6 years, according to the base realignment and closure statute.

Census Finds Rise in Uninsured

The Census Bureau reports that 45.8 million Americans were without health insurance in 2004, up from 45 million in 2003. While the increase is statistically small, it means that "an additional 860,000 Americans live without the safety net of health insurance," J. Edward Hill, M.D., president of the American Medical Association, said in a statement. "As the decrease in employment-based health insurance continues, the AMA renews its call for health insurance solutions that put patients in the driver's seat, along with their physicians," Dr. Hill said. Some of these solutions may include refundable tax credits inversely related to income and individually selected and owned health insurance, he said. In other statistics, the number of people with health insurance increased by 2 million to 245.3 million between 2003 and 2004. Those covered by government health insurance rose from 76.8 million in 2003 to 79 million—driven by increases in the percentage and number of people covered by Medicaid.

Seniors Split on Drug Benefit

Patients' optimism about Medicare's new prescription drug benefit has improved over the last few months, although beneficiaries remain split on their support, an August poll conducted by the Kaiser Family Foundation indicated. About one in three (32%) seniors have a favorable impression of the benefit and an equal amount (32%) have a negative one. In April, only one in five (21%) said they had a favorable impression. Comprehension of the benefit has improved: Overall, 37% of seniors now say they understand the new benefit "very" or "somewhat" well, which is up from 29% in April. Six in 10 seniors (60%) say they don't understand the benefit well or at all. The poll represented 1,205 adults 18 years and older, including 300 respondents 65 and older, interviewed by telephone by Princeton Survey Research Associates, on behalf of Kaiser.

Chronic Care Projects Launched

Medicare is launching chronic care pilot projects this year aimed at improving care for people with heart failure and diabetes. The program, called Medicare Health Support, will provide free, voluntary services to about 160,000 Medicare fee-for-service beneficiaries for 3 years. Participating patients will get access to nurse coaches, reminders about preventive care needs, prescription drug counseling, home visits and intensive care management when needed, and home monitoring equipment to track health status. At press time, eight areas had been selected for the program: Maryland, Oklahoma, Western Pennsylvania, Mississippi, Northwest Georgia, Chicago, Central Florida, and Washington, D.C.

Grant Funds Focus on Women

The Women's Health Career Development Award is being offered for the first time in 2006 by the Dermatology Foundation. This grant funds research into a range of disorders that primarily affect women, from lupus and scleroderma to the effects of hormones and environmental factors on the skin. The grant provides a $55,000 annual stipend effective July 1, 2006. Applications for the grant are due Oct. 17. The grant is open to both men and women. Details are available online at

www.dermatologyfoundation.org

www.womensderm.org

Assessing Plastic Surgery

About 85% of participants in a telephone survey who said they had considered plastic surgery reported that the benefits far outweighed the risks, according to a study published in the Sept. 1 issue of Plastic and Reconstructive Surgery. The results are based on 60 in-depth telephone interviews with individuals actively considering plastic surgery. The researchers also conducted an online survey of 644 individuals who reported actively considering surgery. Interviewees said they thought they could minimize their risks by researching the procedure and the surgeons who specialize in that area. Two-thirds of the interview participants said the potential risks would not deter them from seeking surgery, while one-third said they would need to weigh the risks and benefits carefully. The research was funded by the American Society of Plastic Surgeons.

Walter Reed to Close

Walter Reed Army Medical Center in Washington, which has cared for hundreds of thousands of soldiers and dignitaries for the past 96 years, is slated to close as part of the base realignment and closure process. The medical center was tapped by the Department of Defense to be closed and that recommendation was recently approved by members of the Defense Base Realignment and Closure Commission. The commission sent its final report to President Bush on Sept. 8. If the president agrees with the recommendations, he will send the entire list to Congress for a vote. Congress must accept or reject the list in full, but cannot amend it. If the closure is approved, most of the staff and services from the army hospital will be combined with services at the National Naval Medical Center in Bethesda, Md., and renamed the Walter Reed National Military Medical Center. Other services will be moved to Fort Belvoir, Va. Closures and realignments must begin within 2 years of congressional approval and must be completed within 6 years, according to the base realignment and closure statute.

Census Finds Rise in Uninsured

The Census Bureau reports that 45.8 million Americans were without health insurance in 2004, up from 45 million in 2003. While the increase is statistically small, it means that "an additional 860,000 Americans live without the safety net of health insurance," J. Edward Hill, M.D., president of the American Medical Association, said in a statement. "As the decrease in employment-based health insurance continues, the AMA renews its call for health insurance solutions that put patients in the driver's seat, along with their physicians," Dr. Hill said. Some of these solutions may include refundable tax credits inversely related to income and individually selected and owned health insurance, he said. In other statistics, the number of people with health insurance increased by 2 million to 245.3 million between 2003 and 2004. Those covered by government health insurance rose from 76.8 million in 2003 to 79 million—driven by increases in the percentage and number of people covered by Medicaid.

Seniors Split on Drug Benefit

Patients' optimism about Medicare's new prescription drug benefit has improved over the last few months, although beneficiaries remain split on their support, an August poll conducted by the Kaiser Family Foundation indicated. About one in three (32%) seniors have a favorable impression of the benefit and an equal amount (32%) have a negative one. In April, only one in five (21%) said they had a favorable impression. Comprehension of the benefit has improved: Overall, 37% of seniors now say they understand the new benefit "very" or "somewhat" well, which is up from 29% in April. Six in 10 seniors (60%) say they don't understand the benefit well or at all. The poll represented 1,205 adults 18 years and older, including 300 respondents 65 and older, interviewed by telephone by Princeton Survey Research Associates, on behalf of Kaiser.

Chronic Care Projects Launched

Medicare is launching chronic care pilot projects this year aimed at improving care for people with heart failure and diabetes. The program, called Medicare Health Support, will provide free, voluntary services to about 160,000 Medicare fee-for-service beneficiaries for 3 years. Participating patients will get access to nurse coaches, reminders about preventive care needs, prescription drug counseling, home visits and intensive care management when needed, and home monitoring equipment to track health status. At press time, eight areas had been selected for the program: Maryland, Oklahoma, Western Pennsylvania, Mississippi, Northwest Georgia, Chicago, Central Florida, and Washington, D.C.

BOSTON — Choosing an electronic health record for your practice involves a comprehensive readiness and needs assessment, according to participants in a congress sponsored by the American Medical Informatics Association.

A group of about 100 physicians, nurse "informaticians," clinical informaticians, pharmacists, consultants, and others met during AMIA's spring congress to brainstorm ideas about how best to select an EHR.

Participants in the work group, who had a range of experience with electronic health records, contributed their advice, which was then condensed into a short presentation given at the close of the AMIA meeting.

The work group made recommendations in several areas.

Readiness Assessment

Develop an information strategy. The first step is to figure out the organization's information strategy by determining goals, the information needed to achieve those goals, and how the information needs to be accessed.

"If you don't have an information strategy, first and foremost, you're really not ready," said Eric Rose, M.D., a physician consultant for IDX Systems in Seattle, who presented the recommendations from the AMIA workshop on selecting an EHR.

Develop an education strategy. Once an information strategy is in place, the practice needs an education strategy for getting everyone up to speed on the EHR product selection process.

Let everyone in the organization know this is a business transformation process, not an IT project.

Don't try to nail down costs too precisely. While it's important to have a budget, practices also need to recognize that some of the costs will be unpredictable, the group advised.

Determine the capabilities, willingness, and expectations of everyone in the practice.

Needs Assessment

Next, practices should assess their needs in terms of features and functions, the work group concluded.

Focus on "pain points" to uncover functional requirements. "Don't ask people what you want the EHR to do for you, ask people where does it hurt," Dr. Rose suggested.

Figure out the organization-wide goals and objectives to determine its EHR needs.

Assess your in-house IT expertise to determine desirable features. If the practice employs a skilled database analyst, it may not need an EHR with built-in reporting functionality, Dr. Rose said.

Use available resources on successful needs assessment processes. For example, the Healthcare Information and Management Systems Society has an online selector for electronic health records at

www.ehrselector.com

How to Write an RFP

Once the practice has taken stock of its needs, they can begin to write a request for proposals (RFP).

Keep it simple. "The more complex your RFP is, the more complex the responses will be," Dr. Rose said.

Address all aspects of the practice's relationship with the vendor in the RFP. An RFP should ask: What training options are available? How much will training cost? How do software upgrades work? How will the vendor work with third-party vendors?

Ask vendors to differentiate themselves from the competition. The RFP is one way to get vendors to tell you what they can offer that is different or better than other companies.

Involve all clinical disciplines in RFP development.

Establish a straightforward, replicable assessment process before sending out the RFP. Practices should be able to redo the RFP in case the procurement process is derailed or one of the key staff members leaves the practice.

Site Visits and Demos

When a practice has narrowed down its choice of vendors, the physicians and administrators may want to begin demonstrations and site visits to test the products.

Consider site visit locations other than those suggested by the vendor. The AMIA group recommended that physicians do their own research to find out who is using a vendor's software. Don't just call the references on a vendor's list, seek out independent sources, the work group reported.

Call ahead when conducting site visits. Practices should try to make the most of the visit by calling ahead and making sure they are visiting a similar organization. The site visit team should collect contact information to bring back for those staff members who couldn't attend the site visit but may want to ask follow-up questions over the phone.

In scripted demonstrations, hold back some portion to be revealed at the time of the demo. The AMIA group suggested that practice representatives ask a few unplanned questions to get around some the lack of transparency in the scripted process.

Make scoring simple and explicit.

BOSTON — Choosing an electronic health record for your practice involves a comprehensive readiness and needs assessment, according to participants in a congress sponsored by the American Medical Informatics Association.

A group of about 100 physicians, nurse "informaticians," clinical informaticians, pharmacists, consultants, and others met during AMIA's spring congress to brainstorm ideas about how best to select an EHR.

Participants in the work group, who had a range of experience with electronic health records, contributed their advice, which was then condensed into a short presentation given at the close of the AMIA meeting.

The work group made recommendations in several areas.

Readiness Assessment

Develop an information strategy. The first step is to figure out the organization's information strategy by determining goals, the information needed to achieve those goals, and how the information needs to be accessed.

"If you don't have an information strategy, first and foremost, you're really not ready," said Eric Rose, M.D., a physician consultant for IDX Systems in Seattle, who presented the recommendations from the AMIA workshop on selecting an EHR.

Develop an education strategy. Once an information strategy is in place, the practice needs an education strategy for getting everyone up to speed on the EHR product selection process.

Let everyone in the organization know this is a business transformation process, not an IT project.

Don't try to nail down costs too precisely. While it's important to have a budget, practices also need to recognize that some of the costs will be unpredictable, the group advised.

Determine the capabilities, willingness, and expectations of everyone in the practice.

Needs Assessment

Next, practices should assess their needs in terms of features and functions, the work group concluded.

Focus on "pain points" to uncover functional requirements. "Don't ask people what you want the EHR to do for you, ask people where does it hurt," Dr. Rose suggested.

Figure out the organization-wide goals and objectives to determine its EHR needs.

Assess your in-house IT expertise to determine desirable features. If the practice employs a skilled database analyst, it may not need an EHR with built-in reporting functionality, Dr. Rose said.

Use available resources on successful needs assessment processes. For example, the Healthcare Information and Management Systems Society has an online selector for electronic health records at

www.ehrselector.com

How to Write an RFP

Once the practice has taken stock of its needs, they can begin to write a request for proposals (RFP).

Keep it simple. "The more complex your RFP is, the more complex the responses will be," Dr. Rose said.

Address all aspects of the practice's relationship with the vendor in the RFP. An RFP should ask: What training options are available? How much will training cost? How do software upgrades work? How will the vendor work with third-party vendors?

Ask vendors to differentiate themselves from the competition. The RFP is one way to get vendors to tell you what they can offer that is different or better than other companies.

Involve all clinical disciplines in RFP development.

Establish a straightforward, replicable assessment process before sending out the RFP. Practices should be able to redo the RFP in case the procurement process is derailed or one of the key staff members leaves the practice.

Site Visits and Demos

When a practice has narrowed down its choice of vendors, the physicians and administrators may want to begin demonstrations and site visits to test the products.

Consider site visit locations other than those suggested by the vendor. The AMIA group recommended that physicians do their own research to find out who is using a vendor's software. Don't just call the references on a vendor's list, seek out independent sources, the work group reported.

Call ahead when conducting site visits. Practices should try to make the most of the visit by calling ahead and making sure they are visiting a similar organization. The site visit team should collect contact information to bring back for those staff members who couldn't attend the site visit but may want to ask follow-up questions over the phone.

In scripted demonstrations, hold back some portion to be revealed at the time of the demo. The AMIA group suggested that practice representatives ask a few unplanned questions to get around some the lack of transparency in the scripted process.

Make scoring simple and explicit.

BOSTON — Choosing an electronic health record for your practice involves a comprehensive readiness and needs assessment, according to participants in a congress sponsored by the American Medical Informatics Association.

A group of about 100 physicians, nurse "informaticians," clinical informaticians, pharmacists, consultants, and others met during AMIA's spring congress to brainstorm ideas about how best to select an EHR.

Participants in the work group, who had a range of experience with electronic health records, contributed their advice, which was then condensed into a short presentation given at the close of the AMIA meeting.

The work group made recommendations in several areas.

Readiness Assessment

Develop an information strategy. The first step is to figure out the organization's information strategy by determining goals, the information needed to achieve those goals, and how the information needs to be accessed.

"If you don't have an information strategy, first and foremost, you're really not ready," said Eric Rose, M.D., a physician consultant for IDX Systems in Seattle, who presented the recommendations from the AMIA workshop on selecting an EHR.

Develop an education strategy. Once an information strategy is in place, the practice needs an education strategy for getting everyone up to speed on the EHR product selection process.

Let everyone in the organization know this is a business transformation process, not an IT project.

Don't try to nail down costs too precisely. While it's important to have a budget, practices also need to recognize that some of the costs will be unpredictable, the group advised.

Determine the capabilities, willingness, and expectations of everyone in the practice.

Needs Assessment

Next, practices should assess their needs in terms of features and functions, the work group concluded.

Focus on "pain points" to uncover functional requirements. "Don't ask people what you want the EHR to do for you, ask people where does it hurt," Dr. Rose suggested.

Figure out the organization-wide goals and objectives to determine its EHR needs.

Assess your in-house IT expertise to determine desirable features. If the practice employs a skilled database analyst, it may not need an EHR with built-in reporting functionality, Dr. Rose said.

Use available resources on successful needs assessment processes. For example, the Healthcare Information and Management Systems Society has an online selector for electronic health records at

www.ehrselector.com

How to Write an RFP

Once the practice has taken stock of its needs, they can begin to write a request for proposals (RFP).

Keep it simple. "The more complex your RFP is, the more complex the responses will be," Dr. Rose said.

Address all aspects of the practice's relationship with the vendor in the RFP. An RFP should ask: What training options are available? How much will training cost? How do software upgrades work? How will the vendor work with third-party vendors?

Ask vendors to differentiate themselves from the competition. The RFP is one way to get vendors to tell you what they can offer that is different or better than other companies.

Involve all clinical disciplines in RFP development.

Establish a straightforward, replicable assessment process before sending out the RFP. Practices should be able to redo the RFP in case the procurement process is derailed or one of the key staff members leaves the practice.

Site Visits and Demos

When a practice has narrowed down its choice of vendors, the physicians and administrators may want to begin demonstrations and site visits to test the products.

Consider site visit locations other than those suggested by the vendor. The AMIA group recommended that physicians do their own research to find out who is using a vendor's software. Don't just call the references on a vendor's list, seek out independent sources, the work group reported.

Call ahead when conducting site visits. Practices should try to make the most of the visit by calling ahead and making sure they are visiting a similar organization. The site visit team should collect contact information to bring back for those staff members who couldn't attend the site visit but may want to ask follow-up questions over the phone.

In scripted demonstrations, hold back some portion to be revealed at the time of the demo. The AMIA group suggested that practice representatives ask a few unplanned questions to get around some the lack of transparency in the scripted process.

Make scoring simple and explicit.

Keepsake Ultrasound

The American Institute of Ultrasound in Medicine (AIUM) is taking a tougher stance on the use of ultrasound for nonmedical purposes. Only images or video clips given to patients during a medically indicated ultrasound exam are consistent with the ethical principles of physician professional organizations such as the American Medical Association and the American College of Obstetricians and Gynecologists, the AIUM said in a new position statement. Fetal ultrasound scans should be performed only by either physicians or registered (or registry-eligible) sonographers. These professionals have been trained to recognize medically important conditions and know techniques to avoid excessive ultrasound exposure. AIUM said that added cost arrangements—other than providing patients with images or copies of their medical records at cost—may violate professional ethical principles. AIUM's updated position statement was developed by a task force created to consider the various aspects of the use of ultrasound for entertainment. The task force also considered comments from AIUM members.

Court Upholds Military Abortion Ban

A federal appeals court last month struck down a decision that required the military to pay for an abortion by a woman whose fetus was anencephalic. Congress has prohibited the military from using federal funds for abortions except in cases in which the woman's life would be endangered if the fetus were carried to term. The woman, who is the wife of a naval enlisted man, won a lower court decision forcing the military to pay for her abortion. She argued that, because the fetus had a fatal birth defect, carrying the fetus to term would not serve the state's interest of preserving life. But the government appealed the ruling to obtain reimbursement for the cost of the procedure. The three-judge appeals panel found that the prohibition on the use of federal funds for abortions does serve a “legitimate government purpose.” The woman can now choose to appeal the ruling to the full appeals court in the 9th circuit or appeal directly to the U.S. Supreme Court.

NIH Funds New Stem Cell Centers

Officials at the National Institutes of Health have funded three new Exploratory Centers for Human Embryonic Stem Cell Research. The centers are located at the Mount Sinai School of Medicine in New York, the Albert Einstein College of Medicine in New York, and the Burnham Institute in La Jolla, Calif. The centers will receive about $9 million over 3 years. Each center will set up a core facility to support and train scientists and to identify the growth conditions and molecular characteristics needed for maintaining human embryonic stem cells in an undifferentiated state. The NIH has already funded three stem cell research centers. All of the centers are limited to using federally approved stem cell lines that are listed on the NIH Human Embryonic Stem Cell Registry.

Barriers to Birth Control Use

Conspiracy beliefs may affect birth control use by African American men and women, according to a study published in the journal Health Education and Behavior. More than one-third of African Americans surveyed agreed with the statement “medical and public health institutions use poor and minority people as guinea pigs to try out new birth control methods.” And only half of those surveyed agreed with the statement “the government tells the truth about the safety and side effects of new birth control methods.” However, a greater percentage of men agreed with specific conspiracy statements than did women. “In general, men held stronger birth control conspiracy beliefs than did women, and men's contraceptive safety conspiracy beliefs were associated with not using birth control,” the study said. “In contrast, women who reported stronger conspiracy beliefs were no more or less likely to be using birth control than other women.” However, women who used birth control and reported stronger agreement with conspiracy theories related to birth control were less likely to use provider-based methods, such as hormonal methods or sterilization. The study is based on a telephone survey of African Americans aged 15–44 years in the United States.

Waiting Lists for AIDS Drugs

A special presidential initiative that offered $20 million in one-time funding to provide HIV/AIDS medications is slated to expire this month, leaving more than 1,400 individuals on waiting lists for the medication, according to an analysis from the National Alliance of State and Territorial AIDS Directors. With the influx of these patients, waiting lists for HIV/ AIDS drugs in nine states are expected to climb to more than 1,922 people, the group reported. Several more state AIDS drug assistance programs are also implementing cost-containment strategies that could continue or increase in 2006, the group said.

Keepsake Ultrasound

The American Institute of Ultrasound in Medicine (AIUM) is taking a tougher stance on the use of ultrasound for nonmedical purposes. Only images or video clips given to patients during a medically indicated ultrasound exam are consistent with the ethical principles of physician professional organizations such as the American Medical Association and the American College of Obstetricians and Gynecologists, the AIUM said in a new position statement. Fetal ultrasound scans should be performed only by either physicians or registered (or registry-eligible) sonographers. These professionals have been trained to recognize medically important conditions and know techniques to avoid excessive ultrasound exposure. AIUM said that added cost arrangements—other than providing patients with images or copies of their medical records at cost—may violate professional ethical principles. AIUM's updated position statement was developed by a task force created to consider the various aspects of the use of ultrasound for entertainment. The task force also considered comments from AIUM members.

Court Upholds Military Abortion Ban

A federal appeals court last month struck down a decision that required the military to pay for an abortion by a woman whose fetus was anencephalic. Congress has prohibited the military from using federal funds for abortions except in cases in which the woman's life would be endangered if the fetus were carried to term. The woman, who is the wife of a naval enlisted man, won a lower court decision forcing the military to pay for her abortion. She argued that, because the fetus had a fatal birth defect, carrying the fetus to term would not serve the state's interest of preserving life. But the government appealed the ruling to obtain reimbursement for the cost of the procedure. The three-judge appeals panel found that the prohibition on the use of federal funds for abortions does serve a “legitimate government purpose.” The woman can now choose to appeal the ruling to the full appeals court in the 9th circuit or appeal directly to the U.S. Supreme Court.

NIH Funds New Stem Cell Centers

Officials at the National Institutes of Health have funded three new Exploratory Centers for Human Embryonic Stem Cell Research. The centers are located at the Mount Sinai School of Medicine in New York, the Albert Einstein College of Medicine in New York, and the Burnham Institute in La Jolla, Calif. The centers will receive about $9 million over 3 years. Each center will set up a core facility to support and train scientists and to identify the growth conditions and molecular characteristics needed for maintaining human embryonic stem cells in an undifferentiated state. The NIH has already funded three stem cell research centers. All of the centers are limited to using federally approved stem cell lines that are listed on the NIH Human Embryonic Stem Cell Registry.

Barriers to Birth Control Use

Conspiracy beliefs may affect birth control use by African American men and women, according to a study published in the journal Health Education and Behavior. More than one-third of African Americans surveyed agreed with the statement “medical and public health institutions use poor and minority people as guinea pigs to try out new birth control methods.” And only half of those surveyed agreed with the statement “the government tells the truth about the safety and side effects of new birth control methods.” However, a greater percentage of men agreed with specific conspiracy statements than did women. “In general, men held stronger birth control conspiracy beliefs than did women, and men's contraceptive safety conspiracy beliefs were associated with not using birth control,” the study said. “In contrast, women who reported stronger conspiracy beliefs were no more or less likely to be using birth control than other women.” However, women who used birth control and reported stronger agreement with conspiracy theories related to birth control were less likely to use provider-based methods, such as hormonal methods or sterilization. The study is based on a telephone survey of African Americans aged 15–44 years in the United States.

Waiting Lists for AIDS Drugs

A special presidential initiative that offered $20 million in one-time funding to provide HIV/AIDS medications is slated to expire this month, leaving more than 1,400 individuals on waiting lists for the medication, according to an analysis from the National Alliance of State and Territorial AIDS Directors. With the influx of these patients, waiting lists for HIV/ AIDS drugs in nine states are expected to climb to more than 1,922 people, the group reported. Several more state AIDS drug assistance programs are also implementing cost-containment strategies that could continue or increase in 2006, the group said.

Keepsake Ultrasound

The American Institute of Ultrasound in Medicine (AIUM) is taking a tougher stance on the use of ultrasound for nonmedical purposes. Only images or video clips given to patients during a medically indicated ultrasound exam are consistent with the ethical principles of physician professional organizations such as the American Medical Association and the American College of Obstetricians and Gynecologists, the AIUM said in a new position statement. Fetal ultrasound scans should be performed only by either physicians or registered (or registry-eligible) sonographers. These professionals have been trained to recognize medically important conditions and know techniques to avoid excessive ultrasound exposure. AIUM said that added cost arrangements—other than providing patients with images or copies of their medical records at cost—may violate professional ethical principles. AIUM's updated position statement was developed by a task force created to consider the various aspects of the use of ultrasound for entertainment. The task force also considered comments from AIUM members.

Court Upholds Military Abortion Ban

A federal appeals court last month struck down a decision that required the military to pay for an abortion by a woman whose fetus was anencephalic. Congress has prohibited the military from using federal funds for abortions except in cases in which the woman's life would be endangered if the fetus were carried to term. The woman, who is the wife of a naval enlisted man, won a lower court decision forcing the military to pay for her abortion. She argued that, because the fetus had a fatal birth defect, carrying the fetus to term would not serve the state's interest of preserving life. But the government appealed the ruling to obtain reimbursement for the cost of the procedure. The three-judge appeals panel found that the prohibition on the use of federal funds for abortions does serve a “legitimate government purpose.” The woman can now choose to appeal the ruling to the full appeals court in the 9th circuit or appeal directly to the U.S. Supreme Court.

NIH Funds New Stem Cell Centers

Officials at the National Institutes of Health have funded three new Exploratory Centers for Human Embryonic Stem Cell Research. The centers are located at the Mount Sinai School of Medicine in New York, the Albert Einstein College of Medicine in New York, and the Burnham Institute in La Jolla, Calif. The centers will receive about $9 million over 3 years. Each center will set up a core facility to support and train scientists and to identify the growth conditions and molecular characteristics needed for maintaining human embryonic stem cells in an undifferentiated state. The NIH has already funded three stem cell research centers. All of the centers are limited to using federally approved stem cell lines that are listed on the NIH Human Embryonic Stem Cell Registry.

Barriers to Birth Control Use

Conspiracy beliefs may affect birth control use by African American men and women, according to a study published in the journal Health Education and Behavior. More than one-third of African Americans surveyed agreed with the statement “medical and public health institutions use poor and minority people as guinea pigs to try out new birth control methods.” And only half of those surveyed agreed with the statement “the government tells the truth about the safety and side effects of new birth control methods.” However, a greater percentage of men agreed with specific conspiracy statements than did women. “In general, men held stronger birth control conspiracy beliefs than did women, and men's contraceptive safety conspiracy beliefs were associated with not using birth control,” the study said. “In contrast, women who reported stronger conspiracy beliefs were no more or less likely to be using birth control than other women.” However, women who used birth control and reported stronger agreement with conspiracy theories related to birth control were less likely to use provider-based methods, such as hormonal methods or sterilization. The study is based on a telephone survey of African Americans aged 15–44 years in the United States.

Waiting Lists for AIDS Drugs

A special presidential initiative that offered $20 million in one-time funding to provide HIV/AIDS medications is slated to expire this month, leaving more than 1,400 individuals on waiting lists for the medication, according to an analysis from the National Alliance of State and Territorial AIDS Directors. With the influx of these patients, waiting lists for HIV/ AIDS drugs in nine states are expected to climb to more than 1,922 people, the group reported. Several more state AIDS drug assistance programs are also implementing cost-containment strategies that could continue or increase in 2006, the group said.

Medicare officials are changing the way hospitals get paid to provide cardiac care in an effort to level the playing field between general hospitals and cardiac specialty hospitals.

Proponents of specialty hospitals are welcoming the move, saying it will show that physician owners aren't skimming the cream off the system and are providing efficient care.

But opponents say the payment changes, which go into effect on Oct. 1, don't address the underlying conflict of interest when physicians refer to hospitals in which they have an ownership interest.

Officials at the Centers for Medicare and Medicaid Services are replacing 9 current cardiovascular diagnosis-related groups (DRGs) commonly billed by specialty hospitals with 12 new DRGs that the agency says will better recognize the severity of illness of the patient. The changes affect DRGs for coronary artery bypass graft surgery, permanent pacemaker implantation, percutaneous vascular procedures, and “other” vascular procedures.

In the 2006 Inpatient Prospective Payment System final rule, published in August, CMS said that the changes will address a portion of the “inappropriately higher payments” to specialty hospitals under the current system.

Compared with the current DRGs, the new DRGs have higher average standardized charges for procedures in patients diagnosed with a major cardiovascular condition (MCV), as identified in the ruling, and lower charges for procedures in patients without an MCV diagnosis.

For example, CMS has replaced DRG 107, for coronary bypass with cardiac catheterization, which had average standardized charges of $82,398, with two new DRG codes: New DRG 547 will be used for procedures in patients with an MCV diagnosis carrying a charge of $92,542 (up 12.3%), and new DRG 548 will be used for procedures in patients without an MCV diagnosis, valued at $71,906 (down 12.7%).

The changes to the DRGs are expected to decrease the case-mix index and the resulting payments by an average of 1% among specialty hospitals, according to CMS.

On average, the impact of the changes on any particular hospital group will be small. Urban hospitals are expected to see a 0.1% increase and rural hospitals should see a 0.1% decrease, CMS said.

“We believe these new DRGs are an improvement over the existing DRG structure because they better recognize a patient's severity of illness and, accordingly, permit us to make higher payments for more severely ill patients who require more resources while lowering our payments for less severely ill and less resource-intensive patients,” CMS said in its final ruling.

In the meantime, CMS officials are continuing to examine the specialty hospital issue and could propose further changes to the DRG system for fiscal year 2007.

Samuel Wann, M.D., chairman of cardiovascular medicine at the Wisconsin Heart Hospital, said he has no objection to changes that make payments more accurate. “I'm against gaming the system too,” he said.

Even if payments for some services decrease, Dr. Wann predicts that his hospital will do fine, because it can rely on efficiency and economies of scale.

Regina Herzlinger, a professor at Harvard Business School who has analyzed the issue of specialty hospitals for a number of years, agrees. The more accurate the reimbursement is, the more institutions that provide cost effective care will thrive, she said.

“My bet is that this will be very good for the specialty hospital.” The changes will weed out the less cost effective providers whether they are in general hospitals or specialty hospitals, she said. “They should be competing because they are better and cheaper.”

Richard Coorsh, a spokesman for the Federation of American Hospitals (FAH), also supports the reexamination of DRGs as a way to improve the system overall. But he doesn't see it as addressing the main objection that community hospitals have to physician-owned specialty hospitals—self-referral.

FAH has urged CMS to prohibit physician owners of specialty hospitals to self-referral patients.

And FAH is supporting the Hospital Fair Competition Act of 2005 (S. 1002), which was introduced by Sen. Charles Grassley (R-Iowa) and Sen. Max Baucus (D-Mont.). The legislation would among other things prohibit certain physician self-referrals to physician-owned specialty hospitals.

Congress imposed a moratorium on physician-investor referrals of Medicare or Medicaid patients to new specialty hospitals, effectively freezing their development.

That moratorium expired on June 8, but CMS has established a sort of administrative moratorium by halting processing of Medicare participation applications from specialty hospitals until January 2006.

The Grassley-Baucus legislation is a “step in the right direction,” Mr. Coorsh said. He said FAH officials are hopeful that it will be acted on before the administrative moratorium expires in January 2006.

Medicare officials are changing the way hospitals get paid to provide cardiac care in an effort to level the playing field between general hospitals and cardiac specialty hospitals.

Proponents of specialty hospitals are welcoming the move, saying it will show that physician owners aren't skimming the cream off the system and are providing efficient care.

But opponents say the payment changes, which go into effect on Oct. 1, don't address the underlying conflict of interest when physicians refer to hospitals in which they have an ownership interest.

Officials at the Centers for Medicare and Medicaid Services are replacing 9 current cardiovascular diagnosis-related groups (DRGs) commonly billed by specialty hospitals with 12 new DRGs that the agency says will better recognize the severity of illness of the patient. The changes affect DRGs for coronary artery bypass graft surgery, permanent pacemaker implantation, percutaneous vascular procedures, and “other” vascular procedures.

In the 2006 Inpatient Prospective Payment System final rule, published in August, CMS said that the changes will address a portion of the “inappropriately higher payments” to specialty hospitals under the current system.

Compared with the current DRGs, the new DRGs have higher average standardized charges for procedures in patients diagnosed with a major cardiovascular condition (MCV), as identified in the ruling, and lower charges for procedures in patients without an MCV diagnosis.

For example, CMS has replaced DRG 107, for coronary bypass with cardiac catheterization, which had average standardized charges of $82,398, with two new DRG codes: New DRG 547 will be used for procedures in patients with an MCV diagnosis carrying a charge of $92,542 (up 12.3%), and new DRG 548 will be used for procedures in patients without an MCV diagnosis, valued at $71,906 (down 12.7%).

The changes to the DRGs are expected to decrease the case-mix index and the resulting payments by an average of 1% among specialty hospitals, according to CMS.

On average, the impact of the changes on any particular hospital group will be small. Urban hospitals are expected to see a 0.1% increase and rural hospitals should see a 0.1% decrease, CMS said.

“We believe these new DRGs are an improvement over the existing DRG structure because they better recognize a patient's severity of illness and, accordingly, permit us to make higher payments for more severely ill patients who require more resources while lowering our payments for less severely ill and less resource-intensive patients,” CMS said in its final ruling.

In the meantime, CMS officials are continuing to examine the specialty hospital issue and could propose further changes to the DRG system for fiscal year 2007.

Samuel Wann, M.D., chairman of cardiovascular medicine at the Wisconsin Heart Hospital, said he has no objection to changes that make payments more accurate. “I'm against gaming the system too,” he said.

Even if payments for some services decrease, Dr. Wann predicts that his hospital will do fine, because it can rely on efficiency and economies of scale.

Regina Herzlinger, a professor at Harvard Business School who has analyzed the issue of specialty hospitals for a number of years, agrees. The more accurate the reimbursement is, the more institutions that provide cost effective care will thrive, she said.

“My bet is that this will be very good for the specialty hospital.” The changes will weed out the less cost effective providers whether they are in general hospitals or specialty hospitals, she said. “They should be competing because they are better and cheaper.”

Richard Coorsh, a spokesman for the Federation of American Hospitals (FAH), also supports the reexamination of DRGs as a way to improve the system overall. But he doesn't see it as addressing the main objection that community hospitals have to physician-owned specialty hospitals—self-referral.

FAH has urged CMS to prohibit physician owners of specialty hospitals to self-referral patients.

And FAH is supporting the Hospital Fair Competition Act of 2005 (S. 1002), which was introduced by Sen. Charles Grassley (R-Iowa) and Sen. Max Baucus (D-Mont.). The legislation would among other things prohibit certain physician self-referrals to physician-owned specialty hospitals.

Congress imposed a moratorium on physician-investor referrals of Medicare or Medicaid patients to new specialty hospitals, effectively freezing their development.

That moratorium expired on June 8, but CMS has established a sort of administrative moratorium by halting processing of Medicare participation applications from specialty hospitals until January 2006.

The Grassley-Baucus legislation is a “step in the right direction,” Mr. Coorsh said. He said FAH officials are hopeful that it will be acted on before the administrative moratorium expires in January 2006.

Medicare officials are changing the way hospitals get paid to provide cardiac care in an effort to level the playing field between general hospitals and cardiac specialty hospitals.

Proponents of specialty hospitals are welcoming the move, saying it will show that physician owners aren't skimming the cream off the system and are providing efficient care.

But opponents say the payment changes, which go into effect on Oct. 1, don't address the underlying conflict of interest when physicians refer to hospitals in which they have an ownership interest.

Officials at the Centers for Medicare and Medicaid Services are replacing 9 current cardiovascular diagnosis-related groups (DRGs) commonly billed by specialty hospitals with 12 new DRGs that the agency says will better recognize the severity of illness of the patient. The changes affect DRGs for coronary artery bypass graft surgery, permanent pacemaker implantation, percutaneous vascular procedures, and “other” vascular procedures.

In the 2006 Inpatient Prospective Payment System final rule, published in August, CMS said that the changes will address a portion of the “inappropriately higher payments” to specialty hospitals under the current system.

Compared with the current DRGs, the new DRGs have higher average standardized charges for procedures in patients diagnosed with a major cardiovascular condition (MCV), as identified in the ruling, and lower charges for procedures in patients without an MCV diagnosis.

For example, CMS has replaced DRG 107, for coronary bypass with cardiac catheterization, which had average standardized charges of $82,398, with two new DRG codes: New DRG 547 will be used for procedures in patients with an MCV diagnosis carrying a charge of $92,542 (up 12.3%), and new DRG 548 will be used for procedures in patients without an MCV diagnosis, valued at $71,906 (down 12.7%).

The changes to the DRGs are expected to decrease the case-mix index and the resulting payments by an average of 1% among specialty hospitals, according to CMS.

On average, the impact of the changes on any particular hospital group will be small. Urban hospitals are expected to see a 0.1% increase and rural hospitals should see a 0.1% decrease, CMS said.

“We believe these new DRGs are an improvement over the existing DRG structure because they better recognize a patient's severity of illness and, accordingly, permit us to make higher payments for more severely ill patients who require more resources while lowering our payments for less severely ill and less resource-intensive patients,” CMS said in its final ruling.

In the meantime, CMS officials are continuing to examine the specialty hospital issue and could propose further changes to the DRG system for fiscal year 2007.

Samuel Wann, M.D., chairman of cardiovascular medicine at the Wisconsin Heart Hospital, said he has no objection to changes that make payments more accurate. “I'm against gaming the system too,” he said.

Even if payments for some services decrease, Dr. Wann predicts that his hospital will do fine, because it can rely on efficiency and economies of scale.

Regina Herzlinger, a professor at Harvard Business School who has analyzed the issue of specialty hospitals for a number of years, agrees. The more accurate the reimbursement is, the more institutions that provide cost effective care will thrive, she said.

“My bet is that this will be very good for the specialty hospital.” The changes will weed out the less cost effective providers whether they are in general hospitals or specialty hospitals, she said. “They should be competing because they are better and cheaper.”

Richard Coorsh, a spokesman for the Federation of American Hospitals (FAH), also supports the reexamination of DRGs as a way to improve the system overall. But he doesn't see it as addressing the main objection that community hospitals have to physician-owned specialty hospitals—self-referral.

FAH has urged CMS to prohibit physician owners of specialty hospitals to self-referral patients.

And FAH is supporting the Hospital Fair Competition Act of 2005 (S. 1002), which was introduced by Sen. Charles Grassley (R-Iowa) and Sen. Max Baucus (D-Mont.). The legislation would among other things prohibit certain physician self-referrals to physician-owned specialty hospitals.

Congress imposed a moratorium on physician-investor referrals of Medicare or Medicaid patients to new specialty hospitals, effectively freezing their development.

That moratorium expired on June 8, but CMS has established a sort of administrative moratorium by halting processing of Medicare participation applications from specialty hospitals until January 2006.

The Grassley-Baucus legislation is a “step in the right direction,” Mr. Coorsh said. He said FAH officials are hopeful that it will be acted on before the administrative moratorium expires in January 2006.

Frist Pledges Stem Cell Support

Senate Majority Leader Bill Frist (R-Tenn.) has shifted his support to legislation to expand federal funding for human embryonic stem cell research. Sen. Frist, a physician, previously backed President Bush's policy of limiting federal funding to stem cell lines derived before Aug. 9, 2001. In a speech on the Senate floor this summer, Sen. Frist said that although the Stem Cell Research Enhancement Act (H.R. 810), which was passed by the House in May, has “significant shortcomings,” he will support it. The bill would allow federal funding for embryonic stem cell research for cells derived from human embryos that were created for the purpose of fertility treatment and otherwise would be discarded. Sen. Frist's support is expected to increase the chances of Senate passage of legislation to expand funding to all stem cell lines derived within ethical guidelines. President Bush has vowed to veto the bill.

The State of Pregnancy

Women having unplanned pregnancies are less likely to seek prenatal care and make other healthy choices during their first trimester, according to a recent survey sponsored by First Response. Of women who have had a planned pregnancy, 99% reported visiting the doctor regularly, versus 80% of women whose pregnancy was unplanned. Women who had an unplanned pregnancy were also less likely to take prenatal multivitamins (94% versus 72%) and to reduce alcohol consumption (58% versus 48%). Of the women who reported that they had been pregnant, 55% said their pregnancy was unplanned. The online survey, conducted by Harris Interactive, included more than 1,200 women aged 18–44; of these, 723 have been pregnant.

Caring for Homeless Women

Ob.gyns. should provide care to homeless women in their individual practices without bias but should also work to implement programs for the homeless with their local hospitals and clinics, according to a recent policy statement from the American College of Obstetricians and Gynecologists. The ACOG Committee Opinion, issued last month by the ACOG Committee on Health Care for Underserved Women, recommends that homeless women receive prenatal care that is coordinated with social services, rehabilitation programs, and programs to help women who live in homeless shelters during pregnancy (Obstet. Gynecol. 2005;106:429–34). “Even though individual obstetrician-gynecologists can and do provide services to homeless patients in their practices, it may be more beneficial for communities to develop organized services targeted specifically to this population that can better provide both health care and support services,” the committee wrote. The committee recommended that ob.gyns. advocate for professional liability protections for physicians who volunteer to provide care to the homeless.

Environmental Exposure

An advocacy organization is calling on the Centers for Disease Control and Prevention to begin testing the umbilical cord blood of newborns, citing the results of its own tests of 10 cord blood samples. The Environmental Working Group (EWG) commissioned tests of 10 cord blood samples and found that the babies averaged 200 contaminants in their blood. The group found the presence of mercury, fire retardants, pesticides, and the Teflon chemical perfluorooctanoic acid. “Chemical exposures during childhood can be far more harmful than those later in life,” EWG's vice president for research Jane Houlihan said in a statement. “Our cord blood findings above all raise the need for testing that ensures the safety of the widespread exposures we've documented that begin even before birth.” The group recommended changes to the federal Toxic Substances Control Act that would require chemical manufacturers to demonstrate that the chemicals they sell are safe for the entire population, including a fetus. The report is available at

www.ewg.org/reports/bodyburden2

Heart Trials and Women

More women should be recruited to participate in clinical trials of heart disease to have “statistically sufficient power” to identify whether women respond differently to treatment than men, according to a study published in August in the European Heart Journal (2005;26:1585–95). The study analyzed the literature on female-specific aspects in the pharmacotherapy of chronic cardiovascular diseases. The authors recommended that researchers analyze data on hormonal aspects, such as concomitant hormone therapy, gender differences in pharmacodynamics and in complication rates. “It is essential that trials are designed to provide the necessary data so that researchers know from the outset that they will be able to analyze factors that could contribute to different outcomes for men and women,” Verena Stangl, M.D., a cardiologist in Berlin and senior author of the study said in a statement.

Frist Pledges Stem Cell Support

Senate Majority Leader Bill Frist (R-Tenn.) has shifted his support to legislation to expand federal funding for human embryonic stem cell research. Sen. Frist, a physician, previously backed President Bush's policy of limiting federal funding to stem cell lines derived before Aug. 9, 2001. In a speech on the Senate floor this summer, Sen. Frist said that although the Stem Cell Research Enhancement Act (H.R. 810), which was passed by the House in May, has “significant shortcomings,” he will support it. The bill would allow federal funding for embryonic stem cell research for cells derived from human embryos that were created for the purpose of fertility treatment and otherwise would be discarded. Sen. Frist's support is expected to increase the chances of Senate passage of legislation to expand funding to all stem cell lines derived within ethical guidelines. President Bush has vowed to veto the bill.

The State of Pregnancy

Women having unplanned pregnancies are less likely to seek prenatal care and make other healthy choices during their first trimester, according to a recent survey sponsored by First Response. Of women who have had a planned pregnancy, 99% reported visiting the doctor regularly, versus 80% of women whose pregnancy was unplanned. Women who had an unplanned pregnancy were also less likely to take prenatal multivitamins (94% versus 72%) and to reduce alcohol consumption (58% versus 48%). Of the women who reported that they had been pregnant, 55% said their pregnancy was unplanned. The online survey, conducted by Harris Interactive, included more than 1,200 women aged 18–44; of these, 723 have been pregnant.

Caring for Homeless Women

Ob.gyns. should provide care to homeless women in their individual practices without bias but should also work to implement programs for the homeless with their local hospitals and clinics, according to a recent policy statement from the American College of Obstetricians and Gynecologists. The ACOG Committee Opinion, issued last month by the ACOG Committee on Health Care for Underserved Women, recommends that homeless women receive prenatal care that is coordinated with social services, rehabilitation programs, and programs to help women who live in homeless shelters during pregnancy (Obstet. Gynecol. 2005;106:429–34). “Even though individual obstetrician-gynecologists can and do provide services to homeless patients in their practices, it may be more beneficial for communities to develop organized services targeted specifically to this population that can better provide both health care and support services,” the committee wrote. The committee recommended that ob.gyns. advocate for professional liability protections for physicians who volunteer to provide care to the homeless.

Environmental Exposure

An advocacy organization is calling on the Centers for Disease Control and Prevention to begin testing the umbilical cord blood of newborns, citing the results of its own tests of 10 cord blood samples. The Environmental Working Group (EWG) commissioned tests of 10 cord blood samples and found that the babies averaged 200 contaminants in their blood. The group found the presence of mercury, fire retardants, pesticides, and the Teflon chemical perfluorooctanoic acid. “Chemical exposures during childhood can be far more harmful than those later in life,” EWG's vice president for research Jane Houlihan said in a statement. “Our cord blood findings above all raise the need for testing that ensures the safety of the widespread exposures we've documented that begin even before birth.” The group recommended changes to the federal Toxic Substances Control Act that would require chemical manufacturers to demonstrate that the chemicals they sell are safe for the entire population, including a fetus. The report is available at

www.ewg.org/reports/bodyburden2

Heart Trials and Women

More women should be recruited to participate in clinical trials of heart disease to have “statistically sufficient power” to identify whether women respond differently to treatment than men, according to a study published in August in the European Heart Journal (2005;26:1585–95). The study analyzed the literature on female-specific aspects in the pharmacotherapy of chronic cardiovascular diseases. The authors recommended that researchers analyze data on hormonal aspects, such as concomitant hormone therapy, gender differences in pharmacodynamics and in complication rates. “It is essential that trials are designed to provide the necessary data so that researchers know from the outset that they will be able to analyze factors that could contribute to different outcomes for men and women,” Verena Stangl, M.D., a cardiologist in Berlin and senior author of the study said in a statement.

Frist Pledges Stem Cell Support

Senate Majority Leader Bill Frist (R-Tenn.) has shifted his support to legislation to expand federal funding for human embryonic stem cell research. Sen. Frist, a physician, previously backed President Bush's policy of limiting federal funding to stem cell lines derived before Aug. 9, 2001. In a speech on the Senate floor this summer, Sen. Frist said that although the Stem Cell Research Enhancement Act (H.R. 810), which was passed by the House in May, has “significant shortcomings,” he will support it. The bill would allow federal funding for embryonic stem cell research for cells derived from human embryos that were created for the purpose of fertility treatment and otherwise would be discarded. Sen. Frist's support is expected to increase the chances of Senate passage of legislation to expand funding to all stem cell lines derived within ethical guidelines. President Bush has vowed to veto the bill.

The State of Pregnancy

Women having unplanned pregnancies are less likely to seek prenatal care and make other healthy choices during their first trimester, according to a recent survey sponsored by First Response. Of women who have had a planned pregnancy, 99% reported visiting the doctor regularly, versus 80% of women whose pregnancy was unplanned. Women who had an unplanned pregnancy were also less likely to take prenatal multivitamins (94% versus 72%) and to reduce alcohol consumption (58% versus 48%). Of the women who reported that they had been pregnant, 55% said their pregnancy was unplanned. The online survey, conducted by Harris Interactive, included more than 1,200 women aged 18–44; of these, 723 have been pregnant.

Caring for Homeless Women

Ob.gyns. should provide care to homeless women in their individual practices without bias but should also work to implement programs for the homeless with their local hospitals and clinics, according to a recent policy statement from the American College of Obstetricians and Gynecologists. The ACOG Committee Opinion, issued last month by the ACOG Committee on Health Care for Underserved Women, recommends that homeless women receive prenatal care that is coordinated with social services, rehabilitation programs, and programs to help women who live in homeless shelters during pregnancy (Obstet. Gynecol. 2005;106:429–34). “Even though individual obstetrician-gynecologists can and do provide services to homeless patients in their practices, it may be more beneficial for communities to develop organized services targeted specifically to this population that can better provide both health care and support services,” the committee wrote. The committee recommended that ob.gyns. advocate for professional liability protections for physicians who volunteer to provide care to the homeless.

Environmental Exposure

An advocacy organization is calling on the Centers for Disease Control and Prevention to begin testing the umbilical cord blood of newborns, citing the results of its own tests of 10 cord blood samples. The Environmental Working Group (EWG) commissioned tests of 10 cord blood samples and found that the babies averaged 200 contaminants in their blood. The group found the presence of mercury, fire retardants, pesticides, and the Teflon chemical perfluorooctanoic acid. “Chemical exposures during childhood can be far more harmful than those later in life,” EWG's vice president for research Jane Houlihan said in a statement. “Our cord blood findings above all raise the need for testing that ensures the safety of the widespread exposures we've documented that begin even before birth.” The group recommended changes to the federal Toxic Substances Control Act that would require chemical manufacturers to demonstrate that the chemicals they sell are safe for the entire population, including a fetus. The report is available at

www.ewg.org/reports/bodyburden2

Heart Trials and Women

More women should be recruited to participate in clinical trials of heart disease to have “statistically sufficient power” to identify whether women respond differently to treatment than men, according to a study published in August in the European Heart Journal (2005;26:1585–95). The study analyzed the literature on female-specific aspects in the pharmacotherapy of chronic cardiovascular diseases. The authors recommended that researchers analyze data on hormonal aspects, such as concomitant hormone therapy, gender differences in pharmacodynamics and in complication rates. “It is essential that trials are designed to provide the necessary data so that researchers know from the outset that they will be able to analyze factors that could contribute to different outcomes for men and women,” Verena Stangl, M.D., a cardiologist in Berlin and senior author of the study said in a statement.

ATLANTA — The use of oral contraceptives appears to decrease the premenstrual worsening of depressive symptoms, Hadine Joffe, M.D., said at the annual meeting of the American Psychiatric Association.

In preliminary research, the use of augmentation with oral contraceptive pills was evaluated in women who already take antidepressants but experience worsening symptoms during the luteal phase of the menstrual cycle, said Dr. Joffe, a psychiatrist at Massachusetts General Hospital, Boston.

The 17 women who completed the study reduced their depression scores during the premenstrual phase on the Daily Record of Severity of Problems Scale from a median score of 58 to a median score of 35.3. In addition, their Montgomery-Asberg Depression Rating Scale scores improved from a median of 20 to a median of 4.

A total of 26 women, aged 18–45 years, were randomized to a double-blind treatment with an oral contraceptive containing drospirenone and ethinyl estradiol (Yasmin). One group received additional ethinyl estradiol on days 22–28, which is the typical placebo week of the oral contraceptive pills.

To be eligible for the 2-month study, women had to have regular 25- to 35-day menstrual cycles, a depressive disorder, and stable use of an antidepressant for 2 months or more. In addition, all participants completed a run-in tracking month before starting the oral contraceptive pill. Depressive symptoms were found to be present only during the premenstrual phase.

Of the women included in the study, 82% had major depression, 12% had minor depression, and 6% had dysthymia.

The oral contraceptive pills were well tolerated, and there appeared to be no difference between women who received the additional ethinyl estradiol during days 22–28 of their cycles and those who received placebo during that time.

The study was sponsored by the National Alliance for Research on Schizophrenia and Depression, and product support was provided by Berlex, which manufactures Yasmin.

ATLANTA — The use of oral contraceptives appears to decrease the premenstrual worsening of depressive symptoms, Hadine Joffe, M.D., said at the annual meeting of the American Psychiatric Association.

In preliminary research, the use of augmentation with oral contraceptive pills was evaluated in women who already take antidepressants but experience worsening symptoms during the luteal phase of the menstrual cycle, said Dr. Joffe, a psychiatrist at Massachusetts General Hospital, Boston.

The 17 women who completed the study reduced their depression scores during the premenstrual phase on the Daily Record of Severity of Problems Scale from a median score of 58 to a median score of 35.3. In addition, their Montgomery-Asberg Depression Rating Scale scores improved from a median of 20 to a median of 4.

A total of 26 women, aged 18–45 years, were randomized to a double-blind treatment with an oral contraceptive containing drospirenone and ethinyl estradiol (Yasmin). One group received additional ethinyl estradiol on days 22–28, which is the typical placebo week of the oral contraceptive pills.

To be eligible for the 2-month study, women had to have regular 25- to 35-day menstrual cycles, a depressive disorder, and stable use of an antidepressant for 2 months or more. In addition, all participants completed a run-in tracking month before starting the oral contraceptive pill. Depressive symptoms were found to be present only during the premenstrual phase.

Of the women included in the study, 82% had major depression, 12% had minor depression, and 6% had dysthymia.

The oral contraceptive pills were well tolerated, and there appeared to be no difference between women who received the additional ethinyl estradiol during days 22–28 of their cycles and those who received placebo during that time.

The study was sponsored by the National Alliance for Research on Schizophrenia and Depression, and product support was provided by Berlex, which manufactures Yasmin.

ATLANTA — The use of oral contraceptives appears to decrease the premenstrual worsening of depressive symptoms, Hadine Joffe, M.D., said at the annual meeting of the American Psychiatric Association.

In preliminary research, the use of augmentation with oral contraceptive pills was evaluated in women who already take antidepressants but experience worsening symptoms during the luteal phase of the menstrual cycle, said Dr. Joffe, a psychiatrist at Massachusetts General Hospital, Boston.

The 17 women who completed the study reduced their depression scores during the premenstrual phase on the Daily Record of Severity of Problems Scale from a median score of 58 to a median score of 35.3. In addition, their Montgomery-Asberg Depression Rating Scale scores improved from a median of 20 to a median of 4.

A total of 26 women, aged 18–45 years, were randomized to a double-blind treatment with an oral contraceptive containing drospirenone and ethinyl estradiol (Yasmin). One group received additional ethinyl estradiol on days 22–28, which is the typical placebo week of the oral contraceptive pills.

To be eligible for the 2-month study, women had to have regular 25- to 35-day menstrual cycles, a depressive disorder, and stable use of an antidepressant for 2 months or more. In addition, all participants completed a run-in tracking month before starting the oral contraceptive pill. Depressive symptoms were found to be present only during the premenstrual phase.

Of the women included in the study, 82% had major depression, 12% had minor depression, and 6% had dysthymia.

The oral contraceptive pills were well tolerated, and there appeared to be no difference between women who received the additional ethinyl estradiol during days 22–28 of their cycles and those who received placebo during that time.

The study was sponsored by the National Alliance for Research on Schizophrenia and Depression, and product support was provided by Berlex, which manufactures Yasmin.

Merck Loses First Vioxx Lawsuit

A jury in Texas last month awarded $253 million to the widow of a man who died after taking Vioxx (rofecoxib). The plaintiff charged that the drug maker Merck & Co. failed to warn physicians about the danger posed by Vioxx, that the drug was improperly designed, and that the company's negligence caused the death of the plaintiff's husband, Robert Ernst. Merck executives plan to appeal the verdict on the grounds that the jury was allowed to hear testimony that was both irrelevant and not based on reliable science, the company said. “While we are disappointed with the verdict, this decision should be put in its appropriate context,” Kenneth C. Frazier, Merck's senior vice president and general counsel, said in a statement. “This is the first of many trials. Each case has a different set of facts. Regardless of the outcome in this single case, the fact remains that plaintiffs have a significant legal burden in proving causation.” The award included $24 million in actual damages and $229 million in punitive damages. But the punitive damages could be reduced to about $2 million, according to Merck, since punitive damages are limited under Texas law.

Drug Acquisition Program Delay

Physicians who plan to participate in the Medicare Competitive Acquisition Program (CAP) for Part B Drugs and Biologicals will have to wait an extra 6 months for the launch of the program. Under CAP, as currently envisioned by Medicare, physicians would obtain drugs from a vendor and the vendor would be responsible for billing Medicare and collecting coinsurance or deductibles from patients. Officials at the Centers for Medicare and Medicaid Services announced last month that the agency is suspending the current CAP vendor bidding process. The bids had been scheduled to be due Aug. 5, but CMS officials are putting that process on hold to “more fully review public comments” and make clarifications to the bidding process. CMS officials expect to publish a final rule on CAP in late 2005, and bidding will open for all vendors again after the rule is published. If everything proceeds on schedule, drugs could be first delivered under the program by July 2006.

SEGRA Development Partnership

AstraZeneca and Schering AG are partnering for research and development in the area of Selective Glucocorticoid Receptor Agonists (SEGRAs). The two companies are planning to collaborate until the end of phase I clinical trials aimed at identifying novel SEGRAs. The 3-year agreement gives AstraZeneca an exclusive, worldwide license to develop and market compounds for rheumatoid and respiratory diseases. Schering AG, which has an advanced collection of identified SEGRAs, will have the exclusive, worldwide license for all other indications. Schering will also receive upfront fees, with both companies retaining rights to future payments and royalties. The full financial terms of the agreement were not made public.

Bones 101

The U.S. Bone and Joint Decade, an organization aimed at increasing awareness of musculoskeletal conditions, is launching a pilot project this fall on bone health and osteoporosis education. The program will include 1-hour educational sessions aimed at men and women in their mid-50s and 60s, to be held at public libraries and health clubs in at least six locations around the United States. Appropriately, the program's working title is “Fit to a T,” as in the T scores commonly used to gauge a person's bone density and susceptibility to fragility fracture. Participants will learn how to discuss their bone health with their physician and also how to assess their living environment for falling risk.

Spine Care Recognition

The National Committee for Quality Assurance (NCQA) is planning to launch a new physician recognition program late next year that will focus on quality care for patients with chronic back pain. The diagnosis and treatment of back pain are highly variable in the United States. While some patients never receive standard interventions, others undergo unnecessary diagnostic imaging and surgery, according to the NCQA. The organization has already convened a 15-member spine care advisory committee charged with providing advice on appropriate, evidence-based performance measures. The committee is made up of clinical researchers from different specialty areas, employers, health plans, and disability insurers. “In many cases, back pain is treated with unnecessary surgery that still leaves the patient in pain,” NCQA President Margaret E. O'Kane said in a statement. “This program will steer people to doctors who not only know how to diagnose back problems, but who also explain the pros and cons of treatment options, help them manage their condition and get well again.”

Clinician's Guide to Alcoholism

Physicians have a new tool to help them identify and care for patients with heavy drinking and alcohol use disorders, About 3 in 10 U.S. adults drink at levels that increase their risk for physical, mental health, and social problems; of these heavy drinkers, about 1 in 4 currently has alcohol dependence problems that often go undetected in medical and mental health care settings. The National Institute on Alcohol Abuse and Alcoholism recently released a new guide called “Helping Patients Who Drink Too Much: A Clinician's Guide,” which offers guidance for conducting brief interventions and managing patient care. If a patient drinks heavily (five or more drinks in a day for men or four or more for women), the guide shows physicians how to look for symptoms of alcohol abuse or dependence. The guide is at

www.niaaa.nih.gov

Merck Loses First Vioxx Lawsuit

A jury in Texas last month awarded $253 million to the widow of a man who died after taking Vioxx (rofecoxib). The plaintiff charged that the drug maker Merck & Co. failed to warn physicians about the danger posed by Vioxx, that the drug was improperly designed, and that the company's negligence caused the death of the plaintiff's husband, Robert Ernst. Merck executives plan to appeal the verdict on the grounds that the jury was allowed to hear testimony that was both irrelevant and not based on reliable science, the company said. “While we are disappointed with the verdict, this decision should be put in its appropriate context,” Kenneth C. Frazier, Merck's senior vice president and general counsel, said in a statement. “This is the first of many trials. Each case has a different set of facts. Regardless of the outcome in this single case, the fact remains that plaintiffs have a significant legal burden in proving causation.” The award included $24 million in actual damages and $229 million in punitive damages. But the punitive damages could be reduced to about $2 million, according to Merck, since punitive damages are limited under Texas law.

Drug Acquisition Program Delay

Physicians who plan to participate in the Medicare Competitive Acquisition Program (CAP) for Part B Drugs and Biologicals will have to wait an extra 6 months for the launch of the program. Under CAP, as currently envisioned by Medicare, physicians would obtain drugs from a vendor and the vendor would be responsible for billing Medicare and collecting coinsurance or deductibles from patients. Officials at the Centers for Medicare and Medicaid Services announced last month that the agency is suspending the current CAP vendor bidding process. The bids had been scheduled to be due Aug. 5, but CMS officials are putting that process on hold to “more fully review public comments” and make clarifications to the bidding process. CMS officials expect to publish a final rule on CAP in late 2005, and bidding will open for all vendors again after the rule is published. If everything proceeds on schedule, drugs could be first delivered under the program by July 2006.

SEGRA Development Partnership

AstraZeneca and Schering AG are partnering for research and development in the area of Selective Glucocorticoid Receptor Agonists (SEGRAs). The two companies are planning to collaborate until the end of phase I clinical trials aimed at identifying novel SEGRAs. The 3-year agreement gives AstraZeneca an exclusive, worldwide license to develop and market compounds for rheumatoid and respiratory diseases. Schering AG, which has an advanced collection of identified SEGRAs, will have the exclusive, worldwide license for all other indications. Schering will also receive upfront fees, with both companies retaining rights to future payments and royalties. The full financial terms of the agreement were not made public.

Bones 101

The U.S. Bone and Joint Decade, an organization aimed at increasing awareness of musculoskeletal conditions, is launching a pilot project this fall on bone health and osteoporosis education. The program will include 1-hour educational sessions aimed at men and women in their mid-50s and 60s, to be held at public libraries and health clubs in at least six locations around the United States. Appropriately, the program's working title is “Fit to a T,” as in the T scores commonly used to gauge a person's bone density and susceptibility to fragility fracture. Participants will learn how to discuss their bone health with their physician and also how to assess their living environment for falling risk.

Spine Care Recognition

The National Committee for Quality Assurance (NCQA) is planning to launch a new physician recognition program late next year that will focus on quality care for patients with chronic back pain. The diagnosis and treatment of back pain are highly variable in the United States. While some patients never receive standard interventions, others undergo unnecessary diagnostic imaging and surgery, according to the NCQA. The organization has already convened a 15-member spine care advisory committee charged with providing advice on appropriate, evidence-based performance measures. The committee is made up of clinical researchers from different specialty areas, employers, health plans, and disability insurers. “In many cases, back pain is treated with unnecessary surgery that still leaves the patient in pain,” NCQA President Margaret E. O'Kane said in a statement. “This program will steer people to doctors who not only know how to diagnose back problems, but who also explain the pros and cons of treatment options, help them manage their condition and get well again.”

Clinician's Guide to Alcoholism

Physicians have a new tool to help them identify and care for patients with heavy drinking and alcohol use disorders, About 3 in 10 U.S. adults drink at levels that increase their risk for physical, mental health, and social problems; of these heavy drinkers, about 1 in 4 currently has alcohol dependence problems that often go undetected in medical and mental health care settings. The National Institute on Alcohol Abuse and Alcoholism recently released a new guide called “Helping Patients Who Drink Too Much: A Clinician's Guide,” which offers guidance for conducting brief interventions and managing patient care. If a patient drinks heavily (five or more drinks in a day for men or four or more for women), the guide shows physicians how to look for symptoms of alcohol abuse or dependence. The guide is at

www.niaaa.nih.gov

Merck Loses First Vioxx Lawsuit

A jury in Texas last month awarded $253 million to the widow of a man who died after taking Vioxx (rofecoxib). The plaintiff charged that the drug maker Merck & Co. failed to warn physicians about the danger posed by Vioxx, that the drug was improperly designed, and that the company's negligence caused the death of the plaintiff's husband, Robert Ernst. Merck executives plan to appeal the verdict on the grounds that the jury was allowed to hear testimony that was both irrelevant and not based on reliable science, the company said. “While we are disappointed with the verdict, this decision should be put in its appropriate context,” Kenneth C. Frazier, Merck's senior vice president and general counsel, said in a statement. “This is the first of many trials. Each case has a different set of facts. Regardless of the outcome in this single case, the fact remains that plaintiffs have a significant legal burden in proving causation.” The award included $24 million in actual damages and $229 million in punitive damages. But the punitive damages could be reduced to about $2 million, according to Merck, since punitive damages are limited under Texas law.

Drug Acquisition Program Delay

Physicians who plan to participate in the Medicare Competitive Acquisition Program (CAP) for Part B Drugs and Biologicals will have to wait an extra 6 months for the launch of the program. Under CAP, as currently envisioned by Medicare, physicians would obtain drugs from a vendor and the vendor would be responsible for billing Medicare and collecting coinsurance or deductibles from patients. Officials at the Centers for Medicare and Medicaid Services announced last month that the agency is suspending the current CAP vendor bidding process. The bids had been scheduled to be due Aug. 5, but CMS officials are putting that process on hold to “more fully review public comments” and make clarifications to the bidding process. CMS officials expect to publish a final rule on CAP in late 2005, and bidding will open for all vendors again after the rule is published. If everything proceeds on schedule, drugs could be first delivered under the program by July 2006.

SEGRA Development Partnership

AstraZeneca and Schering AG are partnering for research and development in the area of Selective Glucocorticoid Receptor Agonists (SEGRAs). The two companies are planning to collaborate until the end of phase I clinical trials aimed at identifying novel SEGRAs. The 3-year agreement gives AstraZeneca an exclusive, worldwide license to develop and market compounds for rheumatoid and respiratory diseases. Schering AG, which has an advanced collection of identified SEGRAs, will have the exclusive, worldwide license for all other indications. Schering will also receive upfront fees, with both companies retaining rights to future payments and royalties. The full financial terms of the agreement were not made public.

Bones 101

The U.S. Bone and Joint Decade, an organization aimed at increasing awareness of musculoskeletal conditions, is launching a pilot project this fall on bone health and osteoporosis education. The program will include 1-hour educational sessions aimed at men and women in their mid-50s and 60s, to be held at public libraries and health clubs in at least six locations around the United States. Appropriately, the program's working title is “Fit to a T,” as in the T scores commonly used to gauge a person's bone density and susceptibility to fragility fracture. Participants will learn how to discuss their bone health with their physician and also how to assess their living environment for falling risk.

Spine Care Recognition

The National Committee for Quality Assurance (NCQA) is planning to launch a new physician recognition program late next year that will focus on quality care for patients with chronic back pain. The diagnosis and treatment of back pain are highly variable in the United States. While some patients never receive standard interventions, others undergo unnecessary diagnostic imaging and surgery, according to the NCQA. The organization has already convened a 15-member spine care advisory committee charged with providing advice on appropriate, evidence-based performance measures. The committee is made up of clinical researchers from different specialty areas, employers, health plans, and disability insurers. “In many cases, back pain is treated with unnecessary surgery that still leaves the patient in pain,” NCQA President Margaret E. O'Kane said in a statement. “This program will steer people to doctors who not only know how to diagnose back problems, but who also explain the pros and cons of treatment options, help them manage their condition and get well again.”

Clinician's Guide to Alcoholism

Physicians have a new tool to help them identify and care for patients with heavy drinking and alcohol use disorders, About 3 in 10 U.S. adults drink at levels that increase their risk for physical, mental health, and social problems; of these heavy drinkers, about 1 in 4 currently has alcohol dependence problems that often go undetected in medical and mental health care settings. The National Institute on Alcohol Abuse and Alcoholism recently released a new guide called “Helping Patients Who Drink Too Much: A Clinician's Guide,” which offers guidance for conducting brief interventions and managing patient care. If a patient drinks heavily (five or more drinks in a day for men or four or more for women), the guide shows physicians how to look for symptoms of alcohol abuse or dependence. The guide is at

www.niaaa.nih.gov

Counterfeit Lipitor

The Food and Drug Administration is alerting U.S. physicians and patients to a recent recall of a batch of counterfeit “Lipitor” (atorvastatin) that was sold in the United Kingdom. U.S. consumers who purchased FDA-approved Lipitor through legitimate U.S. pharmacies should not have received the counterfeit medicine, according to the FDA. However, consumers may have received counterfeit pills if they obtained drugs from the United Kingdom via online or storefront operations that do not supply FDA-approved products, or through state-run drug importation programs that facilitate the purchase of foreign drugs. Initial testing of the counterfeit drug by U.K. health officials showed that the product does not pose an immediate risk to patients. However, the FDA is advising patients that there is no guarantee of quality or effectiveness. Patients who have the counterfeit Lipitor should stop using it and consult their physician or pharmacist if they have questions or concerns. The counterfeit tablets are 20 mg and are sold in packages of 28 tablets. The batch number is 004405K1 with an expiration date of “11 2007.” Legitimate doses of Lipitor sold in Britain also have the same batch number, the FDA reported.

Chronic Care Pilots

Medicare is launching chronic care pilot projects this year aimed at improving care for people with heart failure and diabetes. The program, called Medicare Health Support, will provide free, voluntary services to about 160,000 Medicare fee-for-service beneficiaries for 3 years. Participating patients will get access to nurse coaches, reminders about preventive care needs, prescription drug counseling, home visits and intensive care management when needed, and home monitoring equipment to track health status. At press time, eight areas had been selected for the program: Maryland, Oklahoma, Western Pennsylvania, Mississippi, Northwest Georgia, Chicago, Central Florida, and Washington, D.C. “We are providing beneficiaries additional tools to help them manage their health more effectively and avoid preventable complications,” Health and Human Services Secretary Mike Leavitt said in a statement.

Heart Trials and Women

More women should be recruited to participate in clinical trials of heart disease to have “statistically sufficient power” to identify whether women respond differently to treatment than men, according to a study published in August in the European Heart Journal (2005;26:1585–95). The study analyzed the existing literature on female-specific aspects in the pharmacotherapy of chronic cardiovascular diseases. The authors recommended that researchers analyze data on hormonal aspects, such as concomitant hormone therapy; gender differences in pharmacodynamics and in complication rates should be incorporated as well. “It is essential that trials are designed to provide the necessary data so that researchers know from the outset that they will be able to analyze factors that could contribute to different outcomes for men and women,” Verena Stangl, M.D., a cardiologist in Berlin and senior author of the study, said in a statement.

Taking Obesity Seriously

Most Americans are still taking obesity seriously as a public health problem, despite recent studies indicating that health risks may have been overstated, according to a survey designed by the Harvard School of Public Health in Boston. Only 15% of Americans surveyed said they believed that the health risks of obesity were being overestimated by scientific experts. In fact, 58% said that they thought the experts were portraying the risks accurately, and 22% thought the risks of obesity were being underestimated. And despite the conflicting research results, Americans are continuing to track calories, fat content, and carbohydrates at about the same rate as last year, Robert J. Blendon, M.D., and his colleagues reported. Julie Gerberding, M.D., director of the Centers for Disease Control and Prevention, said in a statement she was encouraged by the results of the poll.

Clinician's Guide to Alcoholism

Physicians have a new tool to help them identify and care for patients with heavy drinking and alcohol use disorders. About 3 in 10 U.S. adults drink at levels that increase their risk for physical, mental health, and social problems. Of these heavy drinkers, about one in four currently has alcohol dependence problems that often go undetected in medical and mental health care settings. The National Institute on Alcohol Abuse and Alcoholism recently released a new guide called “Helping Patients Who Drink Too Much: A Clinician's Guide,” which offers guidance for conducting brief interventions and managing patient care. The guide shows physicians how to look for symptoms of alcohol abuse or dependence. The guide is at

www.niaaa.nih.gov

Counterfeit Lipitor

The Food and Drug Administration is alerting U.S. physicians and patients to a recent recall of a batch of counterfeit “Lipitor” (atorvastatin) that was sold in the United Kingdom. U.S. consumers who purchased FDA-approved Lipitor through legitimate U.S. pharmacies should not have received the counterfeit medicine, according to the FDA. However, consumers may have received counterfeit pills if they obtained drugs from the United Kingdom via online or storefront operations that do not supply FDA-approved products, or through state-run drug importation programs that facilitate the purchase of foreign drugs. Initial testing of the counterfeit drug by U.K. health officials showed that the product does not pose an immediate risk to patients. However, the FDA is advising patients that there is no guarantee of quality or effectiveness. Patients who have the counterfeit Lipitor should stop using it and consult their physician or pharmacist if they have questions or concerns. The counterfeit tablets are 20 mg and are sold in packages of 28 tablets. The batch number is 004405K1 with an expiration date of “11 2007.” Legitimate doses of Lipitor sold in Britain also have the same batch number, the FDA reported.

Chronic Care Pilots

Medicare is launching chronic care pilot projects this year aimed at improving care for people with heart failure and diabetes. The program, called Medicare Health Support, will provide free, voluntary services to about 160,000 Medicare fee-for-service beneficiaries for 3 years. Participating patients will get access to nurse coaches, reminders about preventive care needs, prescription drug counseling, home visits and intensive care management when needed, and home monitoring equipment to track health status. At press time, eight areas had been selected for the program: Maryland, Oklahoma, Western Pennsylvania, Mississippi, Northwest Georgia, Chicago, Central Florida, and Washington, D.C. “We are providing beneficiaries additional tools to help them manage their health more effectively and avoid preventable complications,” Health and Human Services Secretary Mike Leavitt said in a statement.

Heart Trials and Women

More women should be recruited to participate in clinical trials of heart disease to have “statistically sufficient power” to identify whether women respond differently to treatment than men, according to a study published in August in the European Heart Journal (2005;26:1585–95). The study analyzed the existing literature on female-specific aspects in the pharmacotherapy of chronic cardiovascular diseases. The authors recommended that researchers analyze data on hormonal aspects, such as concomitant hormone therapy; gender differences in pharmacodynamics and in complication rates should be incorporated as well. “It is essential that trials are designed to provide the necessary data so that researchers know from the outset that they will be able to analyze factors that could contribute to different outcomes for men and women,” Verena Stangl, M.D., a cardiologist in Berlin and senior author of the study, said in a statement.

Taking Obesity Seriously

Most Americans are still taking obesity seriously as a public health problem, despite recent studies indicating that health risks may have been overstated, according to a survey designed by the Harvard School of Public Health in Boston. Only 15% of Americans surveyed said they believed that the health risks of obesity were being overestimated by scientific experts. In fact, 58% said that they thought the experts were portraying the risks accurately, and 22% thought the risks of obesity were being underestimated. And despite the conflicting research results, Americans are continuing to track calories, fat content, and carbohydrates at about the same rate as last year, Robert J. Blendon, M.D., and his colleagues reported. Julie Gerberding, M.D., director of the Centers for Disease Control and Prevention, said in a statement she was encouraged by the results of the poll.

Clinician's Guide to Alcoholism

Physicians have a new tool to help them identify and care for patients with heavy drinking and alcohol use disorders. About 3 in 10 U.S. adults drink at levels that increase their risk for physical, mental health, and social problems. Of these heavy drinkers, about one in four currently has alcohol dependence problems that often go undetected in medical and mental health care settings. The National Institute on Alcohol Abuse and Alcoholism recently released a new guide called “Helping Patients Who Drink Too Much: A Clinician's Guide,” which offers guidance for conducting brief interventions and managing patient care. The guide shows physicians how to look for symptoms of alcohol abuse or dependence. The guide is at

www.niaaa.nih.gov

Counterfeit Lipitor

The Food and Drug Administration is alerting U.S. physicians and patients to a recent recall of a batch of counterfeit “Lipitor” (atorvastatin) that was sold in the United Kingdom. U.S. consumers who purchased FDA-approved Lipitor through legitimate U.S. pharmacies should not have received the counterfeit medicine, according to the FDA. However, consumers may have received counterfeit pills if they obtained drugs from the United Kingdom via online or storefront operations that do not supply FDA-approved products, or through state-run drug importation programs that facilitate the purchase of foreign drugs. Initial testing of the counterfeit drug by U.K. health officials showed that the product does not pose an immediate risk to patients. However, the FDA is advising patients that there is no guarantee of quality or effectiveness. Patients who have the counterfeit Lipitor should stop using it and consult their physician or pharmacist if they have questions or concerns. The counterfeit tablets are 20 mg and are sold in packages of 28 tablets. The batch number is 004405K1 with an expiration date of “11 2007.” Legitimate doses of Lipitor sold in Britain also have the same batch number, the FDA reported.

Chronic Care Pilots

Medicare is launching chronic care pilot projects this year aimed at improving care for people with heart failure and diabetes. The program, called Medicare Health Support, will provide free, voluntary services to about 160,000 Medicare fee-for-service beneficiaries for 3 years. Participating patients will get access to nurse coaches, reminders about preventive care needs, prescription drug counseling, home visits and intensive care management when needed, and home monitoring equipment to track health status. At press time, eight areas had been selected for the program: Maryland, Oklahoma, Western Pennsylvania, Mississippi, Northwest Georgia, Chicago, Central Florida, and Washington, D.C. “We are providing beneficiaries additional tools to help them manage their health more effectively and avoid preventable complications,” Health and Human Services Secretary Mike Leavitt said in a statement.

Heart Trials and Women

More women should be recruited to participate in clinical trials of heart disease to have “statistically sufficient power” to identify whether women respond differently to treatment than men, according to a study published in August in the European Heart Journal (2005;26:1585–95). The study analyzed the existing literature on female-specific aspects in the pharmacotherapy of chronic cardiovascular diseases. The authors recommended that researchers analyze data on hormonal aspects, such as concomitant hormone therapy; gender differences in pharmacodynamics and in complication rates should be incorporated as well. “It is essential that trials are designed to provide the necessary data so that researchers know from the outset that they will be able to analyze factors that could contribute to different outcomes for men and women,” Verena Stangl, M.D., a cardiologist in Berlin and senior author of the study, said in a statement.

Taking Obesity Seriously

Most Americans are still taking obesity seriously as a public health problem, despite recent studies indicating that health risks may have been overstated, according to a survey designed by the Harvard School of Public Health in Boston. Only 15% of Americans surveyed said they believed that the health risks of obesity were being overestimated by scientific experts. In fact, 58% said that they thought the experts were portraying the risks accurately, and 22% thought the risks of obesity were being underestimated. And despite the conflicting research results, Americans are continuing to track calories, fat content, and carbohydrates at about the same rate as last year, Robert J. Blendon, M.D., and his colleagues reported. Julie Gerberding, M.D., director of the Centers for Disease Control and Prevention, said in a statement she was encouraged by the results of the poll.

Clinician's Guide to Alcoholism

Physicians have a new tool to help them identify and care for patients with heavy drinking and alcohol use disorders. About 3 in 10 U.S. adults drink at levels that increase their risk for physical, mental health, and social problems. Of these heavy drinkers, about one in four currently has alcohol dependence problems that often go undetected in medical and mental health care settings. The National Institute on Alcohol Abuse and Alcoholism recently released a new guide called “Helping Patients Who Drink Too Much: A Clinician's Guide,” which offers guidance for conducting brief interventions and managing patient care. The guide shows physicians how to look for symptoms of alcohol abuse or dependence. The guide is at

www.niaaa.nih.gov

BOSTON — Three Massachusetts communities will soon be wired for electronic health record systems as part of a $50 million pilot project.

The idea, being undertaken by the Massachusetts eHealth Collaborative, is to test out the implementation of interoperable EHRs within communities before attempting to connect physicians across the entire state.

“We're completely focused on practical solutions so we can get these things into physicians' hands and health care professionals' hands and keep them there,” Micky Tripathi, CEO of the Massachusetts eHealth Collaborative said at a congress sponsored by the American Medical Informatics Association.

The collaborative is a not-for-profit group founded by 34 health care institutions seeking to create a statewide health information network. The collaborative was launched last fall and requested applications for its pilot project last December. They received 35 applications from communities across the state and chose three—greater Brockton, greater Newburyport, and Northern Berkshire. The pilot is being funded through a grant from Blue Cross Blue Shield of Massachusetts.

Each community chosen was a relatively self-contained medical referral market, had strong local health care professional leadership, and demonstrated an openness to information technology (IT) innovation, Mr. Tripathi said.

The final selections were based in part on location, patient diversity, and IT maturity, he said. Members of the collaborative also wanted to choose communities at different points of the IT adoption curve in order to see the different types of benefits. The three communities cover nearly 600 physicians treating roughly 500,000 patients. Overall, there are 182 primary care physicians and 410 specialists. The pilots will include almost 200 offices sites, most of which have one to five physicians, he said.

The pilot projects will include the purchase and installation of EHRs at all clinical care points, as well as connecting them to other systems within the community.

Although existing studies have shown the benefit of EHRs on a small scale, Mr. Tripathi said this pilot is a chance to see what will happen in a larger, community-wide rollout. The pilot will be aimed at determining the barriers to adoption, identifying the costs—both direct and indirect—of adoption, and analyzing the benefits. Officials at the collaborative will also be seeking to figure out how the costs and benefits are distributed across stakeholders.

BOSTON — Three Massachusetts communities will soon be wired for electronic health record systems as part of a $50 million pilot project.

The idea, being undertaken by the Massachusetts eHealth Collaborative, is to test out the implementation of interoperable EHRs within communities before attempting to connect physicians across the entire state.

“We're completely focused on practical solutions so we can get these things into physicians' hands and health care professionals' hands and keep them there,” Micky Tripathi, CEO of the Massachusetts eHealth Collaborative said at a congress sponsored by the American Medical Informatics Association.

The collaborative is a not-for-profit group founded by 34 health care institutions seeking to create a statewide health information network. The collaborative was launched last fall and requested applications for its pilot project last December. They received 35 applications from communities across the state and chose three—greater Brockton, greater Newburyport, and Northern Berkshire. The pilot is being funded through a grant from Blue Cross Blue Shield of Massachusetts.

Each community chosen was a relatively self-contained medical referral market, had strong local health care professional leadership, and demonstrated an openness to information technology (IT) innovation, Mr. Tripathi said.

The final selections were based in part on location, patient diversity, and IT maturity, he said. Members of the collaborative also wanted to choose communities at different points of the IT adoption curve in order to see the different types of benefits. The three communities cover nearly 600 physicians treating roughly 500,000 patients. Overall, there are 182 primary care physicians and 410 specialists. The pilots will include almost 200 offices sites, most of which have one to five physicians, he said.

The pilot projects will include the purchase and installation of EHRs at all clinical care points, as well as connecting them to other systems within the community.

Although existing studies have shown the benefit of EHRs on a small scale, Mr. Tripathi said this pilot is a chance to see what will happen in a larger, community-wide rollout. The pilot will be aimed at determining the barriers to adoption, identifying the costs—both direct and indirect—of adoption, and analyzing the benefits. Officials at the collaborative will also be seeking to figure out how the costs and benefits are distributed across stakeholders.

BOSTON — Three Massachusetts communities will soon be wired for electronic health record systems as part of a $50 million pilot project.

The idea, being undertaken by the Massachusetts eHealth Collaborative, is to test out the implementation of interoperable EHRs within communities before attempting to connect physicians across the entire state.

“We're completely focused on practical solutions so we can get these things into physicians' hands and health care professionals' hands and keep them there,” Micky Tripathi, CEO of the Massachusetts eHealth Collaborative said at a congress sponsored by the American Medical Informatics Association.

The collaborative is a not-for-profit group founded by 34 health care institutions seeking to create a statewide health information network. The collaborative was launched last fall and requested applications for its pilot project last December. They received 35 applications from communities across the state and chose three—greater Brockton, greater Newburyport, and Northern Berkshire. The pilot is being funded through a grant from Blue Cross Blue Shield of Massachusetts.

Each community chosen was a relatively self-contained medical referral market, had strong local health care professional leadership, and demonstrated an openness to information technology (IT) innovation, Mr. Tripathi said.

The final selections were based in part on location, patient diversity, and IT maturity, he said. Members of the collaborative also wanted to choose communities at different points of the IT adoption curve in order to see the different types of benefits. The three communities cover nearly 600 physicians treating roughly 500,000 patients. Overall, there are 182 primary care physicians and 410 specialists. The pilots will include almost 200 offices sites, most of which have one to five physicians, he said.

The pilot projects will include the purchase and installation of EHRs at all clinical care points, as well as connecting them to other systems within the community.

Although existing studies have shown the benefit of EHRs on a small scale, Mr. Tripathi said this pilot is a chance to see what will happen in a larger, community-wide rollout. The pilot will be aimed at determining the barriers to adoption, identifying the costs—both direct and indirect—of adoption, and analyzing the benefits. Officials at the collaborative will also be seeking to figure out how the costs and benefits are distributed across stakeholders.

BOSTON — A coalition of private sector informatics groups plans to launch a process for certifying electronic health record products late this year.

Certification will bring some predictability into the market for physicians, vendors, and payers, Mark Leavitt, M.D., chair of the Certification Commission for Healthcare Information Technology, said at a congress sponsored by the American Medical Informatics Association.

The commission's initial scope is to certify electronic health record (EHR) products for physician offices and other ambulatory settings. They plan to begin beta testing products as part of a pilot project this month.

By the end of the year, the commission is slated to publish certification requirements and to outline a roadmap for vendors for requirements for the next 1–2 years, Dr. Leavitt said.

The roadmap is a key part of the commission's work because the cycle for getting new features, interfaces, and interoperability functions into a product can be 6–18 months or more. “We need to signal to the industry as to where we are going next, so it has time to respond,” he said.

The commission was founded last year by the American Health Information Management Association, the Healthcare Information and Management Systems Society (HIMSS), and the National Alliance for Health Information Technology.

The three groups have provided seed funding and have loaned staff members to the effort. As the process moves forward, the commission will charge fees to the vendors to cover the cost of testing the products.

They also plan to seek sustaining grants from other organizations to maintain their operations, said Dr. Leavitt, who is also the medical director at HIMSS.

Under the voluntary certification process, products will either be certified or not certified. “We are not trying to create a competitive rating system,” Dr. Leavitt said.

The idea is that the commission will be setting a baseline standard, leaving space for competition and innovation above that standard. And the standard needs to be based on reality, he said, to get participation from vendors.

In the first year of certification, the members of the commission want to be sure that they don't create requirements that will shut down the marketplace. However, Dr. Leavitt said he expects that as the standards become more rigorous in the years to come, the marketplace will evolve to follow the certification process.

Currently, adoption is progressing slowly because the market lacks order and predictability. For example, physicians won't buy EHR systems until costs are lower, their own risk is lower, and the incentives are higher. However, it's hard for vendors to bring down prices when the sales volumes are so low and the sales cycle is so costly.

Payers have expressed interest in offering incentives for the use of EHRs, but many are concerned that if they start to offer incentives, an industry of minimal systems will spring up to capture that money, Dr. Leavitt said.

Certification is a way to take some of the risk out of the process for all the players, Dr. Leavitt said.

Another challenge is to make sure that there isn't a wave of adoption of products that aren't interoperable.

“We want to ensure that these products that get adopted will be interoperable in this emerging infrastructure,” according to Dr. Leavitt. “The challenge is the infrastructure isn't there yet, it's emerging.”

For more information on the certification timeline, visit www.cchit.org

BOSTON — A coalition of private sector informatics groups plans to launch a process for certifying electronic health record products late this year.

Certification will bring some predictability into the market for physicians, vendors, and payers, Mark Leavitt, M.D., chair of the Certification Commission for Healthcare Information Technology, said at a congress sponsored by the American Medical Informatics Association.

The commission's initial scope is to certify electronic health record (EHR) products for physician offices and other ambulatory settings. They plan to begin beta testing products as part of a pilot project this month.

By the end of the year, the commission is slated to publish certification requirements and to outline a roadmap for vendors for requirements for the next 1–2 years, Dr. Leavitt said.

The roadmap is a key part of the commission's work because the cycle for getting new features, interfaces, and interoperability functions into a product can be 6–18 months or more. “We need to signal to the industry as to where we are going next, so it has time to respond,” he said.

The commission was founded last year by the American Health Information Management Association, the Healthcare Information and Management Systems Society (HIMSS), and the National Alliance for Health Information Technology.

The three groups have provided seed funding and have loaned staff members to the effort. As the process moves forward, the commission will charge fees to the vendors to cover the cost of testing the products.

They also plan to seek sustaining grants from other organizations to maintain their operations, said Dr. Leavitt, who is also the medical director at HIMSS.

Under the voluntary certification process, products will either be certified or not certified. “We are not trying to create a competitive rating system,” Dr. Leavitt said.

The idea is that the commission will be setting a baseline standard, leaving space for competition and innovation above that standard. And the standard needs to be based on reality, he said, to get participation from vendors.

In the first year of certification, the members of the commission want to be sure that they don't create requirements that will shut down the marketplace. However, Dr. Leavitt said he expects that as the standards become more rigorous in the years to come, the marketplace will evolve to follow the certification process.

Currently, adoption is progressing slowly because the market lacks order and predictability. For example, physicians won't buy EHR systems until costs are lower, their own risk is lower, and the incentives are higher. However, it's hard for vendors to bring down prices when the sales volumes are so low and the sales cycle is so costly.

Payers have expressed interest in offering incentives for the use of EHRs, but many are concerned that if they start to offer incentives, an industry of minimal systems will spring up to capture that money, Dr. Leavitt said.

Certification is a way to take some of the risk out of the process for all the players, Dr. Leavitt said.

Another challenge is to make sure that there isn't a wave of adoption of products that aren't interoperable.

“We want to ensure that these products that get adopted will be interoperable in this emerging infrastructure,” according to Dr. Leavitt. “The challenge is the infrastructure isn't there yet, it's emerging.”

For more information on the certification timeline, visit www.cchit.org

BOSTON — A coalition of private sector informatics groups plans to launch a process for certifying electronic health record products late this year.

Certification will bring some predictability into the market for physicians, vendors, and payers, Mark Leavitt, M.D., chair of the Certification Commission for Healthcare Information Technology, said at a congress sponsored by the American Medical Informatics Association.

The commission's initial scope is to certify electronic health record (EHR) products for physician offices and other ambulatory settings. They plan to begin beta testing products as part of a pilot project this month.

By the end of the year, the commission is slated to publish certification requirements and to outline a roadmap for vendors for requirements for the next 1–2 years, Dr. Leavitt said.

The roadmap is a key part of the commission's work because the cycle for getting new features, interfaces, and interoperability functions into a product can be 6–18 months or more. “We need to signal to the industry as to where we are going next, so it has time to respond,” he said.

The commission was founded last year by the American Health Information Management Association, the Healthcare Information and Management Systems Society (HIMSS), and the National Alliance for Health Information Technology.

The three groups have provided seed funding and have loaned staff members to the effort. As the process moves forward, the commission will charge fees to the vendors to cover the cost of testing the products.

They also plan to seek sustaining grants from other organizations to maintain their operations, said Dr. Leavitt, who is also the medical director at HIMSS.

Under the voluntary certification process, products will either be certified or not certified. “We are not trying to create a competitive rating system,” Dr. Leavitt said.

The idea is that the commission will be setting a baseline standard, leaving space for competition and innovation above that standard. And the standard needs to be based on reality, he said, to get participation from vendors.

In the first year of certification, the members of the commission want to be sure that they don't create requirements that will shut down the marketplace. However, Dr. Leavitt said he expects that as the standards become more rigorous in the years to come, the marketplace will evolve to follow the certification process.

Currently, adoption is progressing slowly because the market lacks order and predictability. For example, physicians won't buy EHR systems until costs are lower, their own risk is lower, and the incentives are higher. However, it's hard for vendors to bring down prices when the sales volumes are so low and the sales cycle is so costly.

Payers have expressed interest in offering incentives for the use of EHRs, but many are concerned that if they start to offer incentives, an industry of minimal systems will spring up to capture that money, Dr. Leavitt said.

Certification is a way to take some of the risk out of the process for all the players, Dr. Leavitt said.

Another challenge is to make sure that there isn't a wave of adoption of products that aren't interoperable.

“We want to ensure that these products that get adopted will be interoperable in this emerging infrastructure,” according to Dr. Leavitt. “The challenge is the infrastructure isn't there yet, it's emerging.”

For more information on the certification timeline, visit www.cchit.org