Mary Ellen Schneider

Physicians will face a nearly 10% cut in Medicare payments in 2008 if Congress does not act to reverse it in the next few months.

Officials at the Centers for Medicare and Medicaid Services published a proposed rule outlining the projected 9.9% payment cut and other policy changes under the Medicare Physician Fee Schedule in the July 12 Federal Register; the agency will accept comments until Aug. 31. The final rule will be published later this year.

A 9.9% cut would have devastating effects on physicians and patients but is unlikely to be carried out, physicians said in interviews. Instead, Congress is likely to follow the pattern of the last 5 years and provide a 1- or 2-year temporary reprieve.

By law, CMS officials must adjust physician payments according to the sustainable growth rate (SGR) formula, which calculates physician payments based in part on the gross domestic product. The major medical specialty societies have been lobbying for years to change the formula, which they say does not account for their rising practice costs.

A permanent fix is unlikely to come this year or even before the 2008 presidential election, said Dr. Rick Kellerman, president of the American Academy of Family Physicians. However, there is an understanding among most members of Congress that significant payment cuts are not realistic and some type of temporary fix must be passed this year, he said.

“Physicians are going to have to gear up to encourage Congress to avert the cut,” Dr. Kellerman said.

Dr. Kellerman envisions a 1- or 2-year positive update to the fee schedule. A 2-year fix would be better, he said, since physicians and policy makers are wasting so much time addressing the payment issue each year. As a result, he said, other important issues such as expanding health care coverage for the uninsured, health information technology adoption, medical education funding, and primary care workforce issues have not been given their due.

Even before any reduced access to physicians began to occur under the proposed cuts, quality and safety issues would develop as physicians struggled to do more with less, said Dr. Richard Hellman, president of the American Association of Clinical Endocrinologists. Quality and safety would suffer as physicians tried to see patients faster and refer complex conditions earlier, he predicted.

The projected cuts would also threaten to derail the voluntary CMs' Physician Quality Reporting Initiative (PQRI) that began July 1, Dr. Hellman said.

The PQRI program gives physicians a chance to earn up to a 1.5% bonus payment on all of their allowed Medicare charges if they report on certain quality indicators. CMS officials have touted the program as the first step in aligning payments with quality.

But a significant payment cut could hamper those efforts, Dr. Hellman said, noting that physicians are unlikely to put the effort into a time-consuming, resource-intensive program where they can earn a 1.5% bonus when facing a 9.9% payment cut at the same time.

The proposed rule also addresses the continuance of PQRI in 2008, and outlines new quality measures for next year. CMS officials are also considering the feasibility of accepting clinical data from electronic health records. The agency will weigh whether to accept data on a limited number of ambulatory care PQRI measures for which data may also be submitted under the current Doctors Office Quality Information Technology Project (DOQ-IT). In 2008, submission through an electronic health record would be an alternative to the current claims-based reporting of data.

The proposed rule also outlines ways the agency would like to test the use of clinical data registries to report PQRI data. The testing, which would begin 2008, would evaluate methods for physicians to report data to clinical data registries and the registries to submit the data on the physician's behalf to CMS. For example, the Society of Thoracic Surgeons has a national database registry that collects quality data on cardiac surgeries, including two PQRI quality measures. However, under the current setup for 2007 and 2008, physicians must report these measures separately to CMS through the claims-based reporting process.

CMS officials are proposing to fund the bonus payments for the 2008 PQRI program by using $1.35 billion provided by Congress as part of the Physician Assistance and Quality Initiative Fund. In the proposed rule, CMS said the bonus payments were likely to be about 1.5% of allowed Medicare charges, not to exceed 2%.

That decision was criticized by the American Medical Association, which said the $1.35 billion should be used to reduce the projected 2008 physician pay cut. CMS estimates the $1.35 billion would reduce the projected cut by about 2%.

“The AMA and 85 other physician and health professional organizations sent a letter strongly urging the Administration to use this money to help Medicare physician payments keep pace with increases in practice costs. The Medicare Payment Advisory Commission made a similar recommendation,” Dr. Cecil B. Wilson, AMA board member, said in a statement. “CMS has chosen to spend all of the money to provide just 1.5% to 2% to physicians who report on certain quality measures.”

Physicians will face a nearly 10% cut in Medicare payments in 2008 if Congress does not act to reverse it in the next few months.

Officials at the Centers for Medicare and Medicaid Services published a proposed rule outlining the projected 9.9% payment cut and other policy changes under the Medicare Physician Fee Schedule in the July 12 Federal Register; the agency will accept comments until Aug. 31. The final rule will be published later this year.

A 9.9% cut would have devastating effects on physicians and patients but is unlikely to be carried out, physicians said in interviews. Instead, Congress is likely to follow the pattern of the last 5 years and provide a 1- or 2-year temporary reprieve.

By law, CMS officials must adjust physician payments according to the sustainable growth rate (SGR) formula, which calculates physician payments based in part on the gross domestic product. The major medical specialty societies have been lobbying for years to change the formula, which they say does not account for their rising practice costs.

A permanent fix is unlikely to come this year or even before the 2008 presidential election, said Dr. Rick Kellerman, president of the American Academy of Family Physicians. However, there is an understanding among most members of Congress that significant payment cuts are not realistic and some type of temporary fix must be passed this year, he said.

“Physicians are going to have to gear up to encourage Congress to avert the cut,” Dr. Kellerman said.

Dr. Kellerman envisions a 1- or 2-year positive update to the fee schedule. A 2-year fix would be better, he said, since physicians and policy makers are wasting so much time addressing the payment issue each year. As a result, he said, other important issues such as expanding health care coverage for the uninsured, health information technology adoption, medical education funding, and primary care workforce issues have not been given their due.

Even before any reduced access to physicians began to occur under the proposed cuts, quality and safety issues would develop as physicians struggled to do more with less, said Dr. Richard Hellman, president of the American Association of Clinical Endocrinologists. Quality and safety would suffer as physicians tried to see patients faster and refer complex conditions earlier, he predicted.

The projected cuts would also threaten to derail the voluntary CMs' Physician Quality Reporting Initiative (PQRI) that began July 1, Dr. Hellman said.

The PQRI program gives physicians a chance to earn up to a 1.5% bonus payment on all of their allowed Medicare charges if they report on certain quality indicators. CMS officials have touted the program as the first step in aligning payments with quality.

But a significant payment cut could hamper those efforts, Dr. Hellman said, noting that physicians are unlikely to put the effort into a time-consuming, resource-intensive program where they can earn a 1.5% bonus when facing a 9.9% payment cut at the same time.

The proposed rule also addresses the continuance of PQRI in 2008, and outlines new quality measures for next year. CMS officials are also considering the feasibility of accepting clinical data from electronic health records. The agency will weigh whether to accept data on a limited number of ambulatory care PQRI measures for which data may also be submitted under the current Doctors Office Quality Information Technology Project (DOQ-IT). In 2008, submission through an electronic health record would be an alternative to the current claims-based reporting of data.

The proposed rule also outlines ways the agency would like to test the use of clinical data registries to report PQRI data. The testing, which would begin 2008, would evaluate methods for physicians to report data to clinical data registries and the registries to submit the data on the physician's behalf to CMS. For example, the Society of Thoracic Surgeons has a national database registry that collects quality data on cardiac surgeries, including two PQRI quality measures. However, under the current setup for 2007 and 2008, physicians must report these measures separately to CMS through the claims-based reporting process.

CMS officials are proposing to fund the bonus payments for the 2008 PQRI program by using $1.35 billion provided by Congress as part of the Physician Assistance and Quality Initiative Fund. In the proposed rule, CMS said the bonus payments were likely to be about 1.5% of allowed Medicare charges, not to exceed 2%.

That decision was criticized by the American Medical Association, which said the $1.35 billion should be used to reduce the projected 2008 physician pay cut. CMS estimates the $1.35 billion would reduce the projected cut by about 2%.

“The AMA and 85 other physician and health professional organizations sent a letter strongly urging the Administration to use this money to help Medicare physician payments keep pace with increases in practice costs. The Medicare Payment Advisory Commission made a similar recommendation,” Dr. Cecil B. Wilson, AMA board member, said in a statement. “CMS has chosen to spend all of the money to provide just 1.5% to 2% to physicians who report on certain quality measures.”

Physicians will face a nearly 10% cut in Medicare payments in 2008 if Congress does not act to reverse it in the next few months.

Officials at the Centers for Medicare and Medicaid Services published a proposed rule outlining the projected 9.9% payment cut and other policy changes under the Medicare Physician Fee Schedule in the July 12 Federal Register; the agency will accept comments until Aug. 31. The final rule will be published later this year.

A 9.9% cut would have devastating effects on physicians and patients but is unlikely to be carried out, physicians said in interviews. Instead, Congress is likely to follow the pattern of the last 5 years and provide a 1- or 2-year temporary reprieve.

By law, CMS officials must adjust physician payments according to the sustainable growth rate (SGR) formula, which calculates physician payments based in part on the gross domestic product. The major medical specialty societies have been lobbying for years to change the formula, which they say does not account for their rising practice costs.

A permanent fix is unlikely to come this year or even before the 2008 presidential election, said Dr. Rick Kellerman, president of the American Academy of Family Physicians. However, there is an understanding among most members of Congress that significant payment cuts are not realistic and some type of temporary fix must be passed this year, he said.

“Physicians are going to have to gear up to encourage Congress to avert the cut,” Dr. Kellerman said.

Dr. Kellerman envisions a 1- or 2-year positive update to the fee schedule. A 2-year fix would be better, he said, since physicians and policy makers are wasting so much time addressing the payment issue each year. As a result, he said, other important issues such as expanding health care coverage for the uninsured, health information technology adoption, medical education funding, and primary care workforce issues have not been given their due.

Even before any reduced access to physicians began to occur under the proposed cuts, quality and safety issues would develop as physicians struggled to do more with less, said Dr. Richard Hellman, president of the American Association of Clinical Endocrinologists. Quality and safety would suffer as physicians tried to see patients faster and refer complex conditions earlier, he predicted.

The projected cuts would also threaten to derail the voluntary CMs' Physician Quality Reporting Initiative (PQRI) that began July 1, Dr. Hellman said.

The PQRI program gives physicians a chance to earn up to a 1.5% bonus payment on all of their allowed Medicare charges if they report on certain quality indicators. CMS officials have touted the program as the first step in aligning payments with quality.

But a significant payment cut could hamper those efforts, Dr. Hellman said, noting that physicians are unlikely to put the effort into a time-consuming, resource-intensive program where they can earn a 1.5% bonus when facing a 9.9% payment cut at the same time.

The proposed rule also addresses the continuance of PQRI in 2008, and outlines new quality measures for next year. CMS officials are also considering the feasibility of accepting clinical data from electronic health records. The agency will weigh whether to accept data on a limited number of ambulatory care PQRI measures for which data may also be submitted under the current Doctors Office Quality Information Technology Project (DOQ-IT). In 2008, submission through an electronic health record would be an alternative to the current claims-based reporting of data.

The proposed rule also outlines ways the agency would like to test the use of clinical data registries to report PQRI data. The testing, which would begin 2008, would evaluate methods for physicians to report data to clinical data registries and the registries to submit the data on the physician's behalf to CMS. For example, the Society of Thoracic Surgeons has a national database registry that collects quality data on cardiac surgeries, including two PQRI quality measures. However, under the current setup for 2007 and 2008, physicians must report these measures separately to CMS through the claims-based reporting process.

CMS officials are proposing to fund the bonus payments for the 2008 PQRI program by using $1.35 billion provided by Congress as part of the Physician Assistance and Quality Initiative Fund. In the proposed rule, CMS said the bonus payments were likely to be about 1.5% of allowed Medicare charges, not to exceed 2%.

That decision was criticized by the American Medical Association, which said the $1.35 billion should be used to reduce the projected 2008 physician pay cut. CMS estimates the $1.35 billion would reduce the projected cut by about 2%.

“The AMA and 85 other physician and health professional organizations sent a letter strongly urging the Administration to use this money to help Medicare physician payments keep pace with increases in practice costs. The Medicare Payment Advisory Commission made a similar recommendation,” Dr. Cecil B. Wilson, AMA board member, said in a statement. “CMS has chosen to spend all of the money to provide just 1.5% to 2% to physicians who report on certain quality measures.”

ORLANDO — The use of a standardized therapeutic approach for treating severe sepsis may help to mitigate the increased mortality associated with a high body mass index, according to research presented at the annual congress of the Society of Critical Care Medicine.

Dr. Puneet S. Garcha and his colleagues at Drexel University, Philadelphia, performed a retrospective review of 62 patients with severe sepsis who were treated under a standardized therapeutic sepsis guideline based on early goal-directed therapy. The patients were admitted to a tertiary care unit medical ICU over a 15-month period between December 2004 and March 2006.

Patients with a body mass index (BMI) of 30 kg/m

The researchers compared 41 patients with a BMI of 29.9 or less to 21 patients with a BMI of 30 or greater. Patients in both groups had similar mean Acute Physiology and Chronic Health Evaluation (APACHE II) scores (25.8 in the lower BMI group, compared with 25.3 in the higher BMI group). In addition, the time to achievement of resuscitation goals and time from onset of severe sepsis to antibiotic administration was similar in both groups.

The researchers analyzed 28-day mortality, number of days on a ventilator, days spent in the ICU, and days in the hospital in an effort to see the impact of higher BMI on outcomes. None of the factors was statistically significant.

The 28-day mortality among patients with a BMI of 29.9 or less was 32.7%, compared with 34% among those with a BMI of 30 or greater.

While higher BMI was not associated with an increase in 28-day mortality, the researchers did observe a trend in the data indicating increased resource use in that group. For example, patients in the higher BMI group seemed to spend more time in the hospital. Among survivors, those with a BMI of 29.9 or less spent 48 days in the hospital on average, compared with 59 days on average among survivors in the higher BMI group. The difference approached statistical significance (P =.06).

Long-term follow-up will be necessary to determine if the mortality benefit seen at 28 days continues over time despite the morbidity and risk of complications seen in higher BMI patients, the researchers wrote.

ORLANDO — The use of a standardized therapeutic approach for treating severe sepsis may help to mitigate the increased mortality associated with a high body mass index, according to research presented at the annual congress of the Society of Critical Care Medicine.

Dr. Puneet S. Garcha and his colleagues at Drexel University, Philadelphia, performed a retrospective review of 62 patients with severe sepsis who were treated under a standardized therapeutic sepsis guideline based on early goal-directed therapy. The patients were admitted to a tertiary care unit medical ICU over a 15-month period between December 2004 and March 2006.

Patients with a body mass index (BMI) of 30 kg/m

The researchers compared 41 patients with a BMI of 29.9 or less to 21 patients with a BMI of 30 or greater. Patients in both groups had similar mean Acute Physiology and Chronic Health Evaluation (APACHE II) scores (25.8 in the lower BMI group, compared with 25.3 in the higher BMI group). In addition, the time to achievement of resuscitation goals and time from onset of severe sepsis to antibiotic administration was similar in both groups.

The researchers analyzed 28-day mortality, number of days on a ventilator, days spent in the ICU, and days in the hospital in an effort to see the impact of higher BMI on outcomes. None of the factors was statistically significant.

The 28-day mortality among patients with a BMI of 29.9 or less was 32.7%, compared with 34% among those with a BMI of 30 or greater.

While higher BMI was not associated with an increase in 28-day mortality, the researchers did observe a trend in the data indicating increased resource use in that group. For example, patients in the higher BMI group seemed to spend more time in the hospital. Among survivors, those with a BMI of 29.9 or less spent 48 days in the hospital on average, compared with 59 days on average among survivors in the higher BMI group. The difference approached statistical significance (P =.06).

Long-term follow-up will be necessary to determine if the mortality benefit seen at 28 days continues over time despite the morbidity and risk of complications seen in higher BMI patients, the researchers wrote.

ORLANDO — The use of a standardized therapeutic approach for treating severe sepsis may help to mitigate the increased mortality associated with a high body mass index, according to research presented at the annual congress of the Society of Critical Care Medicine.

Dr. Puneet S. Garcha and his colleagues at Drexel University, Philadelphia, performed a retrospective review of 62 patients with severe sepsis who were treated under a standardized therapeutic sepsis guideline based on early goal-directed therapy. The patients were admitted to a tertiary care unit medical ICU over a 15-month period between December 2004 and March 2006.

Patients with a body mass index (BMI) of 30 kg/m

The researchers compared 41 patients with a BMI of 29.9 or less to 21 patients with a BMI of 30 or greater. Patients in both groups had similar mean Acute Physiology and Chronic Health Evaluation (APACHE II) scores (25.8 in the lower BMI group, compared with 25.3 in the higher BMI group). In addition, the time to achievement of resuscitation goals and time from onset of severe sepsis to antibiotic administration was similar in both groups.

The researchers analyzed 28-day mortality, number of days on a ventilator, days spent in the ICU, and days in the hospital in an effort to see the impact of higher BMI on outcomes. None of the factors was statistically significant.

The 28-day mortality among patients with a BMI of 29.9 or less was 32.7%, compared with 34% among those with a BMI of 30 or greater.

While higher BMI was not associated with an increase in 28-day mortality, the researchers did observe a trend in the data indicating increased resource use in that group. For example, patients in the higher BMI group seemed to spend more time in the hospital. Among survivors, those with a BMI of 29.9 or less spent 48 days in the hospital on average, compared with 59 days on average among survivors in the higher BMI group. The difference approached statistical significance (P =.06).

Long-term follow-up will be necessary to determine if the mortality benefit seen at 28 days continues over time despite the morbidity and risk of complications seen in higher BMI patients, the researchers wrote.

Physicians who choose to participate in Medicare's pay for reporting program do not have to satisfy quality indicators to receive a bonus. But in some cases, they will need to cite why they did not follow evidence-based guidelines.

Under the Physician Quality Reporting Initiative (PQRI), which at presstime was slated to begin July 1, reporting for certain measures will include adding a coding modifier explaining why a service was not performed. For example, the service may not have been provided because it was not medically indicated or the patient declined.

The PQRI is a voluntary program that allows physicians to earn a bonus payment of up to 1.5% of total allowed Medicare charges for reporting on certain quality measures. The program will run from July 1 through the end of the year. CMS officials have selected 74 quality measures and physicians are expected to report on between one and three measures, depending on how many apply to them.

When reporting on measures, physicians must include a CPT-II code or G-code. Some measures may also require that physicians add a modifier to the CPT II code if the service was not provided. These modifiers are not used when reporting G codes. The CPT-II modifiers include performance measure exclusion modifiers and a performance measure reporting modifier. For example:

▸ Modifier 1P is used to show that the service was not indicated or is contraindicated for medical reasons.

▸ Modifier 2P is used to indicate that the service was not provided for patient reasons, such as the patient declining or religious objections.

▸ Modifier 3P is used to indicate that the service was not provided for systems reasons such as insurance coverage limitations or a lack of resources to provide the service.

▸ Modifier 8P is a performance measure reporting modifier and indicates that the action was not performed and the reason has not been specified.

Specific instructions on when to use a modifier in the 2007 PQRI Specifications Document, which is available online at www.cms.hhs.gov/pqri

Physicians who choose to participate in Medicare's pay for reporting program do not have to satisfy quality indicators to receive a bonus. But in some cases, they will need to cite why they did not follow evidence-based guidelines.

Under the Physician Quality Reporting Initiative (PQRI), which at presstime was slated to begin July 1, reporting for certain measures will include adding a coding modifier explaining why a service was not performed. For example, the service may not have been provided because it was not medically indicated or the patient declined.

The PQRI is a voluntary program that allows physicians to earn a bonus payment of up to 1.5% of total allowed Medicare charges for reporting on certain quality measures. The program will run from July 1 through the end of the year. CMS officials have selected 74 quality measures and physicians are expected to report on between one and three measures, depending on how many apply to them.

When reporting on measures, physicians must include a CPT-II code or G-code. Some measures may also require that physicians add a modifier to the CPT II code if the service was not provided. These modifiers are not used when reporting G codes. The CPT-II modifiers include performance measure exclusion modifiers and a performance measure reporting modifier. For example:

▸ Modifier 1P is used to show that the service was not indicated or is contraindicated for medical reasons.

▸ Modifier 2P is used to indicate that the service was not provided for patient reasons, such as the patient declining or religious objections.

▸ Modifier 3P is used to indicate that the service was not provided for systems reasons such as insurance coverage limitations or a lack of resources to provide the service.

▸ Modifier 8P is a performance measure reporting modifier and indicates that the action was not performed and the reason has not been specified.

Specific instructions on when to use a modifier in the 2007 PQRI Specifications Document, which is available online at www.cms.hhs.gov/pqri

Physicians who choose to participate in Medicare's pay for reporting program do not have to satisfy quality indicators to receive a bonus. But in some cases, they will need to cite why they did not follow evidence-based guidelines.

Under the Physician Quality Reporting Initiative (PQRI), which at presstime was slated to begin July 1, reporting for certain measures will include adding a coding modifier explaining why a service was not performed. For example, the service may not have been provided because it was not medically indicated or the patient declined.

The PQRI is a voluntary program that allows physicians to earn a bonus payment of up to 1.5% of total allowed Medicare charges for reporting on certain quality measures. The program will run from July 1 through the end of the year. CMS officials have selected 74 quality measures and physicians are expected to report on between one and three measures, depending on how many apply to them.

When reporting on measures, physicians must include a CPT-II code or G-code. Some measures may also require that physicians add a modifier to the CPT II code if the service was not provided. These modifiers are not used when reporting G codes. The CPT-II modifiers include performance measure exclusion modifiers and a performance measure reporting modifier. For example:

▸ Modifier 1P is used to show that the service was not indicated or is contraindicated for medical reasons.

▸ Modifier 2P is used to indicate that the service was not provided for patient reasons, such as the patient declining or religious objections.

▸ Modifier 3P is used to indicate that the service was not provided for systems reasons such as insurance coverage limitations or a lack of resources to provide the service.

▸ Modifier 8P is a performance measure reporting modifier and indicates that the action was not performed and the reason has not been specified.

Specific instructions on when to use a modifier in the 2007 PQRI Specifications Document, which is available online at www.cms.hhs.gov/pqri

Physicians will face a nearly 10% cut in Medicare payments in 2008 if Congress does not act to reverse it in the next few months.

Officials at the Centers for Medicare and Medicaid Services published a proposed rule outlining the projected 9.9% payment cut and other policy changes under the Medicare Physician Fee Schedule in the July 12 Federal Register; the agency will accept comments until Aug. 31. The final fee schedule rule will be published later this year.

A 9.9% cut would have devastating consequences for physicians and patients alike but is unlikely to be carried out, physicians said in interviews. Instead, Congress is likely to follow the pattern of the last 5 years and provide a 1- or 2-year temporary reprieve.

By law, CMS officials must adjust physician payments according to the sustainable growth rate (SGR) formula, which calculates physician payments based in part on the gross domestic product. The major medical specialty societies have been lobbying for years to change the formula, which they say does not account for their rising practice costs.

A permanent fix is unlikely to come this year or even before the 2008 presidential election, said Dr. Rick Kellerman, president of the American Academy of Family Physicians. However, there is an understanding among most members of Congress that significant payment cuts are not realistic and some type of temporary fix must be passed this year, he said.

“Physicians are going to have to gear up to encourage Congress to avert the cut,” Dr. Kellerman said.

Dr. Bruce Sigsbee, a neurologist and a member of the Medical Economics and Management Committee of the American Academy of Neurology, said that if the cut were to go through as projected, the impact would be significant. For example, for neurologists, who operate on fairly lean budgets, the approximately 10% Medicare cut would translate into about a 20% cut in take-home compensation. That presents a real risk of reduced services, he said.

Even before reduced access to physicians began to occur under the proposed cuts, quality and safety issues would develop as physicians struggled to do more with less, said Dr. Richard Hellman, president of the American Association of Clinical Endocrinologists. Quality and safety would suffer as physicians tried to see patients faster and refer complex conditions earlier, he predicted.

The projected cuts would also threaten to derail the voluntary CMs' Physician Quality Reporting Initiative (PQRI) that began July 1, Dr. Hellman said.

The PQRI program gives physicians a chance to earn up to a 1.5% bonus payment on all of their allowed Medicare charges if they report on certain quality indicators. CMS officials have touted the program as the first step in aligning payments with quality.

But a significant payment cut could hamper those efforts, Dr. Hellman said, noting that physicians are unlikely to put the effort into a time-consuming, resource-intensive program where they can earn a 1.5% bonus when facing a 9.9% payment cut at the same time.

The proposed rule also addresses the continuance of PQRI in 2008, and outlines new quality measures for next year. CMS officials are also considering the feasibility of accepting clinical data from electronic health records. The agency will weigh whether to accept data on a limited number of ambulatory care PQRI measures for which data may also be submitted under the current Doctors Office Quality Information Technology Project (DOQ-IT).

In 2008, submission through an electronic health record would be an alternative to the current claims-based reporting of data.

CMS officials are proposing to fund the bonus payments for the 2008 PQRI program by using $1.35 billion provided by Congress as part of the Physician Assistance and Quality Initiative Fund. In the proposed rule, CMS stated that the bonus payments were likely to be about 1.5% of allowed Medicare charges, not to exceed 2%.

That decision was criticized by the American Medical Association, which said the $1.35 billion should be used to reduce the projected 2008 physician pay cut. CMS estimates the $1.35 billion would reduce the projected cut by about 2%.

Physicians will face a nearly 10% cut in Medicare payments in 2008 if Congress does not act to reverse it in the next few months.

Officials at the Centers for Medicare and Medicaid Services published a proposed rule outlining the projected 9.9% payment cut and other policy changes under the Medicare Physician Fee Schedule in the July 12 Federal Register; the agency will accept comments until Aug. 31. The final fee schedule rule will be published later this year.

A 9.9% cut would have devastating consequences for physicians and patients alike but is unlikely to be carried out, physicians said in interviews. Instead, Congress is likely to follow the pattern of the last 5 years and provide a 1- or 2-year temporary reprieve.

By law, CMS officials must adjust physician payments according to the sustainable growth rate (SGR) formula, which calculates physician payments based in part on the gross domestic product. The major medical specialty societies have been lobbying for years to change the formula, which they say does not account for their rising practice costs.

A permanent fix is unlikely to come this year or even before the 2008 presidential election, said Dr. Rick Kellerman, president of the American Academy of Family Physicians. However, there is an understanding among most members of Congress that significant payment cuts are not realistic and some type of temporary fix must be passed this year, he said.

“Physicians are going to have to gear up to encourage Congress to avert the cut,” Dr. Kellerman said.

Dr. Bruce Sigsbee, a neurologist and a member of the Medical Economics and Management Committee of the American Academy of Neurology, said that if the cut were to go through as projected, the impact would be significant. For example, for neurologists, who operate on fairly lean budgets, the approximately 10% Medicare cut would translate into about a 20% cut in take-home compensation. That presents a real risk of reduced services, he said.

Even before reduced access to physicians began to occur under the proposed cuts, quality and safety issues would develop as physicians struggled to do more with less, said Dr. Richard Hellman, president of the American Association of Clinical Endocrinologists. Quality and safety would suffer as physicians tried to see patients faster and refer complex conditions earlier, he predicted.

The projected cuts would also threaten to derail the voluntary CMs' Physician Quality Reporting Initiative (PQRI) that began July 1, Dr. Hellman said.

The PQRI program gives physicians a chance to earn up to a 1.5% bonus payment on all of their allowed Medicare charges if they report on certain quality indicators. CMS officials have touted the program as the first step in aligning payments with quality.

But a significant payment cut could hamper those efforts, Dr. Hellman said, noting that physicians are unlikely to put the effort into a time-consuming, resource-intensive program where they can earn a 1.5% bonus when facing a 9.9% payment cut at the same time.

The proposed rule also addresses the continuance of PQRI in 2008, and outlines new quality measures for next year. CMS officials are also considering the feasibility of accepting clinical data from electronic health records. The agency will weigh whether to accept data on a limited number of ambulatory care PQRI measures for which data may also be submitted under the current Doctors Office Quality Information Technology Project (DOQ-IT).

In 2008, submission through an electronic health record would be an alternative to the current claims-based reporting of data.

CMS officials are proposing to fund the bonus payments for the 2008 PQRI program by using $1.35 billion provided by Congress as part of the Physician Assistance and Quality Initiative Fund. In the proposed rule, CMS stated that the bonus payments were likely to be about 1.5% of allowed Medicare charges, not to exceed 2%.

That decision was criticized by the American Medical Association, which said the $1.35 billion should be used to reduce the projected 2008 physician pay cut. CMS estimates the $1.35 billion would reduce the projected cut by about 2%.

Physicians will face a nearly 10% cut in Medicare payments in 2008 if Congress does not act to reverse it in the next few months.

Officials at the Centers for Medicare and Medicaid Services published a proposed rule outlining the projected 9.9% payment cut and other policy changes under the Medicare Physician Fee Schedule in the July 12 Federal Register; the agency will accept comments until Aug. 31. The final fee schedule rule will be published later this year.

A 9.9% cut would have devastating consequences for physicians and patients alike but is unlikely to be carried out, physicians said in interviews. Instead, Congress is likely to follow the pattern of the last 5 years and provide a 1- or 2-year temporary reprieve.

By law, CMS officials must adjust physician payments according to the sustainable growth rate (SGR) formula, which calculates physician payments based in part on the gross domestic product. The major medical specialty societies have been lobbying for years to change the formula, which they say does not account for their rising practice costs.

A permanent fix is unlikely to come this year or even before the 2008 presidential election, said Dr. Rick Kellerman, president of the American Academy of Family Physicians. However, there is an understanding among most members of Congress that significant payment cuts are not realistic and some type of temporary fix must be passed this year, he said.

“Physicians are going to have to gear up to encourage Congress to avert the cut,” Dr. Kellerman said.

Dr. Bruce Sigsbee, a neurologist and a member of the Medical Economics and Management Committee of the American Academy of Neurology, said that if the cut were to go through as projected, the impact would be significant. For example, for neurologists, who operate on fairly lean budgets, the approximately 10% Medicare cut would translate into about a 20% cut in take-home compensation. That presents a real risk of reduced services, he said.

Even before reduced access to physicians began to occur under the proposed cuts, quality and safety issues would develop as physicians struggled to do more with less, said Dr. Richard Hellman, president of the American Association of Clinical Endocrinologists. Quality and safety would suffer as physicians tried to see patients faster and refer complex conditions earlier, he predicted.

The projected cuts would also threaten to derail the voluntary CMs' Physician Quality Reporting Initiative (PQRI) that began July 1, Dr. Hellman said.

The PQRI program gives physicians a chance to earn up to a 1.5% bonus payment on all of their allowed Medicare charges if they report on certain quality indicators. CMS officials have touted the program as the first step in aligning payments with quality.

But a significant payment cut could hamper those efforts, Dr. Hellman said, noting that physicians are unlikely to put the effort into a time-consuming, resource-intensive program where they can earn a 1.5% bonus when facing a 9.9% payment cut at the same time.

The proposed rule also addresses the continuance of PQRI in 2008, and outlines new quality measures for next year. CMS officials are also considering the feasibility of accepting clinical data from electronic health records. The agency will weigh whether to accept data on a limited number of ambulatory care PQRI measures for which data may also be submitted under the current Doctors Office Quality Information Technology Project (DOQ-IT).

In 2008, submission through an electronic health record would be an alternative to the current claims-based reporting of data.

CMS officials are proposing to fund the bonus payments for the 2008 PQRI program by using $1.35 billion provided by Congress as part of the Physician Assistance and Quality Initiative Fund. In the proposed rule, CMS stated that the bonus payments were likely to be about 1.5% of allowed Medicare charges, not to exceed 2%.

That decision was criticized by the American Medical Association, which said the $1.35 billion should be used to reduce the projected 2008 physician pay cut. CMS estimates the $1.35 billion would reduce the projected cut by about 2%.

TORONTO — The short-term use of either growth hormone or testosterone alone does not significantly improve physical performance among recreational athletes, according to research presented in a poster at the annual meeting of the Endocrine Society.

However, the combination of growth hormone and testosterone did significantly increase sprint capacity in men, the researchers found.

Dr. Ken K.Y. Ho, of the Garvan Institute in Sydney, Australia, and his colleagues conducted a prospective, double-blind placebo-controlled study looking at the effects of growth hormone and testosterone supplementation among 97 recreational athletes from 18–40. The mean age of the study participants was 27 years. The researchers defined a recreational athlete as one who exercised at least 2 hr/wk for at least 1 year.

The study was funded by the World Anti-Doping Agency and the Australian Government Anti-Doping Research Program. The supplements were provided by Novo Nordisk and Organon.

Sixty-four men were randomized to receive either placebo, growth hormone (Norditropin), testosterone (Sustanon), or a combination of growth hormone and testosterone over the 8-week study period. In addition, 33 women were randomized to receive either placebo or growth hormone.

Study participants in the growth hormone or combination arms received up to 2 mg/day of growth hormone for 8 weeks. Men in the testosterone or combination arms received 250 mg/wk of testosterone for 5 weeks. The researchers assessed endurance, strength, power, and sprint capacity using a variety of physical tests.

They found that there was no significant change from baseline among any group in terms of endurance, strength, or power. The only significant finding was among men who took a combination of growth hormone and testosterone. In that group, there was a statistically significant increase in sprint capacity, as measured via a 30-second cycle Wingate test that measured total work and peak power.

TORONTO — The short-term use of either growth hormone or testosterone alone does not significantly improve physical performance among recreational athletes, according to research presented in a poster at the annual meeting of the Endocrine Society.

However, the combination of growth hormone and testosterone did significantly increase sprint capacity in men, the researchers found.

Dr. Ken K.Y. Ho, of the Garvan Institute in Sydney, Australia, and his colleagues conducted a prospective, double-blind placebo-controlled study looking at the effects of growth hormone and testosterone supplementation among 97 recreational athletes from 18–40. The mean age of the study participants was 27 years. The researchers defined a recreational athlete as one who exercised at least 2 hr/wk for at least 1 year.

The study was funded by the World Anti-Doping Agency and the Australian Government Anti-Doping Research Program. The supplements were provided by Novo Nordisk and Organon.

Sixty-four men were randomized to receive either placebo, growth hormone (Norditropin), testosterone (Sustanon), or a combination of growth hormone and testosterone over the 8-week study period. In addition, 33 women were randomized to receive either placebo or growth hormone.

Study participants in the growth hormone or combination arms received up to 2 mg/day of growth hormone for 8 weeks. Men in the testosterone or combination arms received 250 mg/wk of testosterone for 5 weeks. The researchers assessed endurance, strength, power, and sprint capacity using a variety of physical tests.

They found that there was no significant change from baseline among any group in terms of endurance, strength, or power. The only significant finding was among men who took a combination of growth hormone and testosterone. In that group, there was a statistically significant increase in sprint capacity, as measured via a 30-second cycle Wingate test that measured total work and peak power.

TORONTO — The short-term use of either growth hormone or testosterone alone does not significantly improve physical performance among recreational athletes, according to research presented in a poster at the annual meeting of the Endocrine Society.

However, the combination of growth hormone and testosterone did significantly increase sprint capacity in men, the researchers found.

Dr. Ken K.Y. Ho, of the Garvan Institute in Sydney, Australia, and his colleagues conducted a prospective, double-blind placebo-controlled study looking at the effects of growth hormone and testosterone supplementation among 97 recreational athletes from 18–40. The mean age of the study participants was 27 years. The researchers defined a recreational athlete as one who exercised at least 2 hr/wk for at least 1 year.

The study was funded by the World Anti-Doping Agency and the Australian Government Anti-Doping Research Program. The supplements were provided by Novo Nordisk and Organon.

Sixty-four men were randomized to receive either placebo, growth hormone (Norditropin), testosterone (Sustanon), or a combination of growth hormone and testosterone over the 8-week study period. In addition, 33 women were randomized to receive either placebo or growth hormone.

Study participants in the growth hormone or combination arms received up to 2 mg/day of growth hormone for 8 weeks. Men in the testosterone or combination arms received 250 mg/wk of testosterone for 5 weeks. The researchers assessed endurance, strength, power, and sprint capacity using a variety of physical tests.

They found that there was no significant change from baseline among any group in terms of endurance, strength, or power. The only significant finding was among men who took a combination of growth hormone and testosterone. In that group, there was a statistically significant increase in sprint capacity, as measured via a 30-second cycle Wingate test that measured total work and peak power.

TORONTO — Aromatase inhibitors could someday replace clomiphene citrate as the first-line treatment for infertility in patients with polycystic ovary syndrome, Dr. Robert F. Casper said at the annual meeting of the Endocrine Society.

Aromatase inhibitors don't have some of the drawbacks of clomiphene citrate such as a long tissue half-life, high multiple pregnancy rates, and peripheral antiestrogenic effects, he said.

“All of these problems result in a lower pregnancy and live birth rate than you'd expect from the very good efficacy of clomiphene citrate for ovulation induction,” said Dr. Casper, professor of obstetrics and gynecology at the University of Toronto.

Aromatase inhibitors such as letrozole, on the other hand, have a relatively short half-life and result in predominantly monofollicular ovulation when used alone. The drug also results in increased follicular sensitivity to follicle-stimulating hormone (FSH) and does not have adverse effects on the endometrium or cervical mucus.

And aromatase inhibitors are safe for use in ovulation induction, despite a well-publicized report in 2005 that letrozole results in an increased risk of congenital abnormalities, he said. Dr. Casper has a licensing agreement with EMD Serono, of Geneva, which is currently testing an aromatase inhibitor for use in treating infertility.

Many physicians may be reluctant to prescribe letrozole off-label for the treatment of infertility in patients with polycystic ovary syndrome (PCOS), Dr. Casper said, because of warnings from the drug's maker. In November 2005, Novartis, which markets letrozole as Femara for the treatment of breast cancer, issued a letter to physicians warning that that the drug is contraindicated in women with premenopausal endocrine status, in pregnancy, and during lactation because of the potential for maternal and fetal toxicity and fetal malformations.

The warning was based largely on a study presented at the American Society of Reproductive Medicine meeting in 2005 in which researchers examined the outcomes of 150 babies who were born following treatment with letrozole, or letrozole and gonadotropins, compared with a database of about 36,000 deliveries in a low-risk maternity hospital. The researchers, led by Dr. Marinko M. Biljan of the Montreal Fertility Center, found no difference in overall malformations but an increased incidence of locomotor and cardiac malformations in the letrozole group, which was statistically significant.

But there are some problems with the design of the study that call the results into question, Dr. Casper said. For example, the control group was composed of spontaneously conceiving patients without infertility. “It is actually well known that women with infertility, especially women with unexplained infertility, have a higher malformation rate in their babies than women who conceive naturally,” he said.

In addition, two recent studies appear to contradict the findings presented in 2005, according to Dr. Casper. Between 2003 and 2005, Dr. Casper and his colleagues examined 911 pregnancies at five clinics in Canada. The four-arm study included patients who received letrozole, letrozole plus FSH, clomiphene citrate, or clomiphene plus FSH. All of the women in the study were undergoing either intrauterine insemination or timed intercourse, and all were monitored in the same fashion.

The researchers found no difference in the overall malformation rate between clomiphene citrate and letrozole. However, they did find a higher rate of cardiac abnormalities in the babies born to the group of women receiving clomiphene citrate. The children of women in the two clomiphene citrate groups had a combined 1.8% rate of cardiac abnormalities, compared with a combined 0.2% rate among women in both letrozole groups, which was statistically significant (Fertil. Steril. 2006;85:1761–5).

In a follow-up study at the McGill Reproductive Centre and the Toronto Centre for Advanced Reproductive Technology, Dr. Casper and colleagues looked at pregnancies occurring after patients received letrozole and clomiphene for ovulation induction. They compared women taking these drugs with an age-matched control group of spontaneous pregnancies in Toronto. They found no difference in overall malformation rates among the three groups, Dr. Casper said. The follow-up study has not yet been submitted for publication.

TORONTO — Aromatase inhibitors could someday replace clomiphene citrate as the first-line treatment for infertility in patients with polycystic ovary syndrome, Dr. Robert F. Casper said at the annual meeting of the Endocrine Society.

Aromatase inhibitors don't have some of the drawbacks of clomiphene citrate such as a long tissue half-life, high multiple pregnancy rates, and peripheral antiestrogenic effects, he said.

“All of these problems result in a lower pregnancy and live birth rate than you'd expect from the very good efficacy of clomiphene citrate for ovulation induction,” said Dr. Casper, professor of obstetrics and gynecology at the University of Toronto.

Aromatase inhibitors such as letrozole, on the other hand, have a relatively short half-life and result in predominantly monofollicular ovulation when used alone. The drug also results in increased follicular sensitivity to follicle-stimulating hormone (FSH) and does not have adverse effects on the endometrium or cervical mucus.

And aromatase inhibitors are safe for use in ovulation induction, despite a well-publicized report in 2005 that letrozole results in an increased risk of congenital abnormalities, he said. Dr. Casper has a licensing agreement with EMD Serono, of Geneva, which is currently testing an aromatase inhibitor for use in treating infertility.

Many physicians may be reluctant to prescribe letrozole off-label for the treatment of infertility in patients with polycystic ovary syndrome (PCOS), Dr. Casper said, because of warnings from the drug's maker. In November 2005, Novartis, which markets letrozole as Femara for the treatment of breast cancer, issued a letter to physicians warning that that the drug is contraindicated in women with premenopausal endocrine status, in pregnancy, and during lactation because of the potential for maternal and fetal toxicity and fetal malformations.

The warning was based largely on a study presented at the American Society of Reproductive Medicine meeting in 2005 in which researchers examined the outcomes of 150 babies who were born following treatment with letrozole, or letrozole and gonadotropins, compared with a database of about 36,000 deliveries in a low-risk maternity hospital. The researchers, led by Dr. Marinko M. Biljan of the Montreal Fertility Center, found no difference in overall malformations but an increased incidence of locomotor and cardiac malformations in the letrozole group, which was statistically significant.

But there are some problems with the design of the study that call the results into question, Dr. Casper said. For example, the control group was composed of spontaneously conceiving patients without infertility. “It is actually well known that women with infertility, especially women with unexplained infertility, have a higher malformation rate in their babies than women who conceive naturally,” he said.

In addition, two recent studies appear to contradict the findings presented in 2005, according to Dr. Casper. Between 2003 and 2005, Dr. Casper and his colleagues examined 911 pregnancies at five clinics in Canada. The four-arm study included patients who received letrozole, letrozole plus FSH, clomiphene citrate, or clomiphene plus FSH. All of the women in the study were undergoing either intrauterine insemination or timed intercourse, and all were monitored in the same fashion.

The researchers found no difference in the overall malformation rate between clomiphene citrate and letrozole. However, they did find a higher rate of cardiac abnormalities in the babies born to the group of women receiving clomiphene citrate. The children of women in the two clomiphene citrate groups had a combined 1.8% rate of cardiac abnormalities, compared with a combined 0.2% rate among women in both letrozole groups, which was statistically significant (Fertil. Steril. 2006;85:1761–5).

In a follow-up study at the McGill Reproductive Centre and the Toronto Centre for Advanced Reproductive Technology, Dr. Casper and colleagues looked at pregnancies occurring after patients received letrozole and clomiphene for ovulation induction. They compared women taking these drugs with an age-matched control group of spontaneous pregnancies in Toronto. They found no difference in overall malformation rates among the three groups, Dr. Casper said. The follow-up study has not yet been submitted for publication.

TORONTO — Aromatase inhibitors could someday replace clomiphene citrate as the first-line treatment for infertility in patients with polycystic ovary syndrome, Dr. Robert F. Casper said at the annual meeting of the Endocrine Society.

Aromatase inhibitors don't have some of the drawbacks of clomiphene citrate such as a long tissue half-life, high multiple pregnancy rates, and peripheral antiestrogenic effects, he said.

“All of these problems result in a lower pregnancy and live birth rate than you'd expect from the very good efficacy of clomiphene citrate for ovulation induction,” said Dr. Casper, professor of obstetrics and gynecology at the University of Toronto.

Aromatase inhibitors such as letrozole, on the other hand, have a relatively short half-life and result in predominantly monofollicular ovulation when used alone. The drug also results in increased follicular sensitivity to follicle-stimulating hormone (FSH) and does not have adverse effects on the endometrium or cervical mucus.

And aromatase inhibitors are safe for use in ovulation induction, despite a well-publicized report in 2005 that letrozole results in an increased risk of congenital abnormalities, he said. Dr. Casper has a licensing agreement with EMD Serono, of Geneva, which is currently testing an aromatase inhibitor for use in treating infertility.

Many physicians may be reluctant to prescribe letrozole off-label for the treatment of infertility in patients with polycystic ovary syndrome (PCOS), Dr. Casper said, because of warnings from the drug's maker. In November 2005, Novartis, which markets letrozole as Femara for the treatment of breast cancer, issued a letter to physicians warning that that the drug is contraindicated in women with premenopausal endocrine status, in pregnancy, and during lactation because of the potential for maternal and fetal toxicity and fetal malformations.

The warning was based largely on a study presented at the American Society of Reproductive Medicine meeting in 2005 in which researchers examined the outcomes of 150 babies who were born following treatment with letrozole, or letrozole and gonadotropins, compared with a database of about 36,000 deliveries in a low-risk maternity hospital. The researchers, led by Dr. Marinko M. Biljan of the Montreal Fertility Center, found no difference in overall malformations but an increased incidence of locomotor and cardiac malformations in the letrozole group, which was statistically significant.

But there are some problems with the design of the study that call the results into question, Dr. Casper said. For example, the control group was composed of spontaneously conceiving patients without infertility. “It is actually well known that women with infertility, especially women with unexplained infertility, have a higher malformation rate in their babies than women who conceive naturally,” he said.

In addition, two recent studies appear to contradict the findings presented in 2005, according to Dr. Casper. Between 2003 and 2005, Dr. Casper and his colleagues examined 911 pregnancies at five clinics in Canada. The four-arm study included patients who received letrozole, letrozole plus FSH, clomiphene citrate, or clomiphene plus FSH. All of the women in the study were undergoing either intrauterine insemination or timed intercourse, and all were monitored in the same fashion.

The researchers found no difference in the overall malformation rate between clomiphene citrate and letrozole. However, they did find a higher rate of cardiac abnormalities in the babies born to the group of women receiving clomiphene citrate. The children of women in the two clomiphene citrate groups had a combined 1.8% rate of cardiac abnormalities, compared with a combined 0.2% rate among women in both letrozole groups, which was statistically significant (Fertil. Steril. 2006;85:1761–5).

In a follow-up study at the McGill Reproductive Centre and the Toronto Centre for Advanced Reproductive Technology, Dr. Casper and colleagues looked at pregnancies occurring after patients received letrozole and clomiphene for ovulation induction. They compared women taking these drugs with an age-matched control group of spontaneous pregnancies in Toronto. They found no difference in overall malformation rates among the three groups, Dr. Casper said. The follow-up study has not yet been submitted for publication.

Maternity Care Costs Vary by Plan

Pregnant women could face thousands of dollars in out-of-pocket expenses for maternity care because of the high deductibles and cost-sharing requirements of consumer-driven health plans, according to an analysis by the Kaiser Family Foundation and the Georgetown University Health Policy Institute. In comparing 12 different consumer-driven plans to traditional health insurance coverage, the researchers found that there was wide variation among the consumer-driven products. Those plans generally offer lower premiums but higher out-of-pocket costs and are often paired with tax-free savings accounts that are used to cover out-of-pocket expenses. The researchers found that a vaginal delivery in an uncomplicated pregnancy costs about $1,455 out of pocket under a traditional health plan vs. anywhere from $3,000 to $7,884 for consumer-driven coverage. In more expensive birth scenarios, the difference was even greater. An uncomplicated pregnancy with a cesarean delivery costs about $2,244 out of pocket with traditional coverage, compared with anywhere from $3,545 to $9,818 among consumer-driven plans.

Bill Would Aid Contraceptive Access

Members of Congress recently introduced federal legislation aimed at improving access to contraceptives. Rep. Carolyn Maloney (D-N.Y.) and Rep. Christopher Shays (R-Conn.) introduced the “Access to Birth Control (ABC) Act” (H.R. 2596) in the House in June; a companion bill was introduced by Sen. Frank Lautenberg (D-N.J.) in the Senate (S. 1555). The legislation would place several requirements on pharmacies. For example, if a customer requests a contraceptive that is in stock, the pharmacy must provide it without delay. If the contraceptive is out of stock, pharmacy staff must inform the customer, then either locate the medication at another pharmacy or order it. The pharmacy must also ensure that its employees do not intimidate or threaten customers seeking contraceptives, interfere with the delivery of services, breach medical confidentiality, or refuse to fill a valid prescription. The bill was praised by the Planned Parenthood Federation of America, which called pharmacists' refusals to fill prescriptions for contraceptives a “disturbing trend.” Planned Parenthood estimates that women have been denied birth control at the pharmacy in at least 19 states.

Prempro Verdict Overturned

A Pennsylvania judge has overturned a jury verdict that would have cost Wyeth, the maker of Prempro, $3 million. In Jennie Nelson v. Wyeth, the plaintiff alleged that the menopause therapy Prempro had contributed to her breast cancer. In February, the jury agreed and awarded damages of $3 million. Wyeth objected to the verdict, saying that there was no scientific evidence to support a causal link between the hormone therapy and the plaintiff's breast cancer. The company also insisted that it had acted responsibly by performing studies investigating the benefits and risks of hormone therapy and by keeping the Food and Drug Administration informed of the results. In May, the Philadelphia Court of Common Pleas granted Wyeth's motion for posttrial relief and threw out the jury's $3 million verdict.

Sex Differences in Medications

Nearly half the women in a recent survey said they believed that the effectiveness of medications is different in men and women, and a similar percentage check medication labels for these differences. However, this concern does not translate into women asking either their physician or pharmacist about how drugs affect women differently, according to the results of a survey commissioned by the Society for Women's Health Research. For example, about 58% of women said they read the label of prescribed or over-the-counter medications always or most of the time to see if the medication might work differently in women. But 60% said they never ask their pharmacist about these concerns and nearly 48% said they never ask their physician. The results are based on a telephone survey of more than 1,500 U.S. women in April.

Bush Issues Second Stem Cell Veto

President Bush last month for the second time vetoed legislation that would have expanded federal funding for human embryonic stem cell research. The bill, the “Stem Cell Research Enhancement Act of 2007” (S. 5), would have allowed for federal funding of human embryonic stem cell research if the embryos were donated from in vitro fertilization clinics and would otherwise have been discarded. In addition, the legislation called for the written, informed consent of individuals donating embryos and prohibited financial inducements for donation. President Bush said he could not support legislation that would lead to the deliberate destruction of human embryos and instead supports efforts such as adult stem cell research and the use of umbilical cord blood. President Bush also issued an executive order directing Health and Human Services and the National Institutes of Health to ensure that any human pluripotent stem cell lines “produced in ways that do not create, destroy, or harm human embryos” are eligible for federal funding. The order also expands the NIH Human Embryonic Stem Cell Registry to include all types of pluripotent stem cells and renames it the Pluripotent Stem Cell Registry. The move was criticized by advocates for human embryonic stem cell research. President Bush's “executive order directing NIH to continue pursuing alternate forms of research is nothing new, since NIH has already been conducting this research for the past 20 years,” Sean Tipton, president of the Coalition for the Advancement of Medical Research, said in a statement.

Maternity Care Costs Vary by Plan

Pregnant women could face thousands of dollars in out-of-pocket expenses for maternity care because of the high deductibles and cost-sharing requirements of consumer-driven health plans, according to an analysis by the Kaiser Family Foundation and the Georgetown University Health Policy Institute. In comparing 12 different consumer-driven plans to traditional health insurance coverage, the researchers found that there was wide variation among the consumer-driven products. Those plans generally offer lower premiums but higher out-of-pocket costs and are often paired with tax-free savings accounts that are used to cover out-of-pocket expenses. The researchers found that a vaginal delivery in an uncomplicated pregnancy costs about $1,455 out of pocket under a traditional health plan vs. anywhere from $3,000 to $7,884 for consumer-driven coverage. In more expensive birth scenarios, the difference was even greater. An uncomplicated pregnancy with a cesarean delivery costs about $2,244 out of pocket with traditional coverage, compared with anywhere from $3,545 to $9,818 among consumer-driven plans.

Bill Would Aid Contraceptive Access

Members of Congress recently introduced federal legislation aimed at improving access to contraceptives. Rep. Carolyn Maloney (D-N.Y.) and Rep. Christopher Shays (R-Conn.) introduced the “Access to Birth Control (ABC) Act” (H.R. 2596) in the House in June; a companion bill was introduced by Sen. Frank Lautenberg (D-N.J.) in the Senate (S. 1555). The legislation would place several requirements on pharmacies. For example, if a customer requests a contraceptive that is in stock, the pharmacy must provide it without delay. If the contraceptive is out of stock, pharmacy staff must inform the customer, then either locate the medication at another pharmacy or order it. The pharmacy must also ensure that its employees do not intimidate or threaten customers seeking contraceptives, interfere with the delivery of services, breach medical confidentiality, or refuse to fill a valid prescription. The bill was praised by the Planned Parenthood Federation of America, which called pharmacists' refusals to fill prescriptions for contraceptives a “disturbing trend.” Planned Parenthood estimates that women have been denied birth control at the pharmacy in at least 19 states.

Prempro Verdict Overturned

A Pennsylvania judge has overturned a jury verdict that would have cost Wyeth, the maker of Prempro, $3 million. In Jennie Nelson v. Wyeth, the plaintiff alleged that the menopause therapy Prempro had contributed to her breast cancer. In February, the jury agreed and awarded damages of $3 million. Wyeth objected to the verdict, saying that there was no scientific evidence to support a causal link between the hormone therapy and the plaintiff's breast cancer. The company also insisted that it had acted responsibly by performing studies investigating the benefits and risks of hormone therapy and by keeping the Food and Drug Administration informed of the results. In May, the Philadelphia Court of Common Pleas granted Wyeth's motion for posttrial relief and threw out the jury's $3 million verdict.

Sex Differences in Medications

Nearly half the women in a recent survey said they believed that the effectiveness of medications is different in men and women, and a similar percentage check medication labels for these differences. However, this concern does not translate into women asking either their physician or pharmacist about how drugs affect women differently, according to the results of a survey commissioned by the Society for Women's Health Research. For example, about 58% of women said they read the label of prescribed or over-the-counter medications always or most of the time to see if the medication might work differently in women. But 60% said they never ask their pharmacist about these concerns and nearly 48% said they never ask their physician. The results are based on a telephone survey of more than 1,500 U.S. women in April.

Bush Issues Second Stem Cell Veto

President Bush last month for the second time vetoed legislation that would have expanded federal funding for human embryonic stem cell research. The bill, the “Stem Cell Research Enhancement Act of 2007” (S. 5), would have allowed for federal funding of human embryonic stem cell research if the embryos were donated from in vitro fertilization clinics and would otherwise have been discarded. In addition, the legislation called for the written, informed consent of individuals donating embryos and prohibited financial inducements for donation. President Bush said he could not support legislation that would lead to the deliberate destruction of human embryos and instead supports efforts such as adult stem cell research and the use of umbilical cord blood. President Bush also issued an executive order directing Health and Human Services and the National Institutes of Health to ensure that any human pluripotent stem cell lines “produced in ways that do not create, destroy, or harm human embryos” are eligible for federal funding. The order also expands the NIH Human Embryonic Stem Cell Registry to include all types of pluripotent stem cells and renames it the Pluripotent Stem Cell Registry. The move was criticized by advocates for human embryonic stem cell research. President Bush's “executive order directing NIH to continue pursuing alternate forms of research is nothing new, since NIH has already been conducting this research for the past 20 years,” Sean Tipton, president of the Coalition for the Advancement of Medical Research, said in a statement.

Maternity Care Costs Vary by Plan

Pregnant women could face thousands of dollars in out-of-pocket expenses for maternity care because of the high deductibles and cost-sharing requirements of consumer-driven health plans, according to an analysis by the Kaiser Family Foundation and the Georgetown University Health Policy Institute. In comparing 12 different consumer-driven plans to traditional health insurance coverage, the researchers found that there was wide variation among the consumer-driven products. Those plans generally offer lower premiums but higher out-of-pocket costs and are often paired with tax-free savings accounts that are used to cover out-of-pocket expenses. The researchers found that a vaginal delivery in an uncomplicated pregnancy costs about $1,455 out of pocket under a traditional health plan vs. anywhere from $3,000 to $7,884 for consumer-driven coverage. In more expensive birth scenarios, the difference was even greater. An uncomplicated pregnancy with a cesarean delivery costs about $2,244 out of pocket with traditional coverage, compared with anywhere from $3,545 to $9,818 among consumer-driven plans.

Bill Would Aid Contraceptive Access

Members of Congress recently introduced federal legislation aimed at improving access to contraceptives. Rep. Carolyn Maloney (D-N.Y.) and Rep. Christopher Shays (R-Conn.) introduced the “Access to Birth Control (ABC) Act” (H.R. 2596) in the House in June; a companion bill was introduced by Sen. Frank Lautenberg (D-N.J.) in the Senate (S. 1555). The legislation would place several requirements on pharmacies. For example, if a customer requests a contraceptive that is in stock, the pharmacy must provide it without delay. If the contraceptive is out of stock, pharmacy staff must inform the customer, then either locate the medication at another pharmacy or order it. The pharmacy must also ensure that its employees do not intimidate or threaten customers seeking contraceptives, interfere with the delivery of services, breach medical confidentiality, or refuse to fill a valid prescription. The bill was praised by the Planned Parenthood Federation of America, which called pharmacists' refusals to fill prescriptions for contraceptives a “disturbing trend.” Planned Parenthood estimates that women have been denied birth control at the pharmacy in at least 19 states.

Prempro Verdict Overturned

A Pennsylvania judge has overturned a jury verdict that would have cost Wyeth, the maker of Prempro, $3 million. In Jennie Nelson v. Wyeth, the plaintiff alleged that the menopause therapy Prempro had contributed to her breast cancer. In February, the jury agreed and awarded damages of $3 million. Wyeth objected to the verdict, saying that there was no scientific evidence to support a causal link between the hormone therapy and the plaintiff's breast cancer. The company also insisted that it had acted responsibly by performing studies investigating the benefits and risks of hormone therapy and by keeping the Food and Drug Administration informed of the results. In May, the Philadelphia Court of Common Pleas granted Wyeth's motion for posttrial relief and threw out the jury's $3 million verdict.

Sex Differences in Medications

Nearly half the women in a recent survey said they believed that the effectiveness of medications is different in men and women, and a similar percentage check medication labels for these differences. However, this concern does not translate into women asking either their physician or pharmacist about how drugs affect women differently, according to the results of a survey commissioned by the Society for Women's Health Research. For example, about 58% of women said they read the label of prescribed or over-the-counter medications always or most of the time to see if the medication might work differently in women. But 60% said they never ask their pharmacist about these concerns and nearly 48% said they never ask their physician. The results are based on a telephone survey of more than 1,500 U.S. women in April.

Bush Issues Second Stem Cell Veto

President Bush last month for the second time vetoed legislation that would have expanded federal funding for human embryonic stem cell research. The bill, the “Stem Cell Research Enhancement Act of 2007” (S. 5), would have allowed for federal funding of human embryonic stem cell research if the embryos were donated from in vitro fertilization clinics and would otherwise have been discarded. In addition, the legislation called for the written, informed consent of individuals donating embryos and prohibited financial inducements for donation. President Bush said he could not support legislation that would lead to the deliberate destruction of human embryos and instead supports efforts such as adult stem cell research and the use of umbilical cord blood. President Bush also issued an executive order directing Health and Human Services and the National Institutes of Health to ensure that any human pluripotent stem cell lines “produced in ways that do not create, destroy, or harm human embryos” are eligible for federal funding. The order also expands the NIH Human Embryonic Stem Cell Registry to include all types of pluripotent stem cells and renames it the Pluripotent Stem Cell Registry. The move was criticized by advocates for human embryonic stem cell research. President Bush's “executive order directing NIH to continue pursuing alternate forms of research is nothing new, since NIH has already been conducting this research for the past 20 years,” Sean Tipton, president of the Coalition for the Advancement of Medical Research, said in a statement.

TORONTO — Lifestyle treatment should be the first-line therapy for the management of fertility in obese women with polycystic ovary syndrome, according to a consensus panel of the American Society for Reproductive Medicine and the European Society for Human Reproduction.

The consensus finding is based on a review of the evidence conducted in March. This effort was part of a comprehensive review of all infertility treatment in PCOS, the results of which will be forthcoming in the near future, Dr. Kathy Hoeger said at the annual meeting of the Androgen Excess Society.

The available studies suggest that lifestyle interventions that lead to modest weight loss can improve ovulatory function in overweight women with polycystic ovary syndrome, said Dr. Hoeger, of the department of obstetrics and gynecology at the University of Rochester (N.Y.) and a participant in the March consensus meeting.

However, further study is needed on the effect of weight reduction and exercise on live-birth rates, she said. More research is also needed on the appropriate time frame for weight reduction prior to conception.

The general literature shows that lifestyle change is effective for metabolic improvement, but there are no large randomized trials for effect on ovulation induction or restoration of menstrual function. All studies published to date, however, support an improvement in reproductive function with lifestyle change in women with PCOS, she said.

Among the smaller studies that have focused on reproductive outcomes, the findings suggest that modest weight loss—about 5%–10%—can improve reproductive status. “This degree of weight loss does not generally put people into a normal [body mass index] range,” Dr. Hoeger said.

For example, in a nonrandomized study of 67 obese and anovulatory women who were offered an intensive lifestyle intervention over 6 months, there was an overall 9% reduction in starting weight, and 60 of the women resumed spontaneous ovulation. Also, 52 of the women achieved pregnancy, 18 of those spontaneously. Of the 67 women in the study, 45 achieved a live birth (Hum. Reprod. 1998;13:1502–5). In another small study, 9 of 18 women became regular ovulators following a 6-month individualized diet and exercise program. The study included infertile, anovulatory obese women with PCOS. The mean weight loss was less than in the earlier study, about 2%–5%. Resuming ovulation was closely linked with improved insulin sensitivity and reduced percentage of central body fat (J. Clin. Endocrinol. Metab. 1999;84:1470–4).

Some studies have also compared the use of diet and exercise interventions with metformin in stimulating the return of ovulation. For example, Dr. Hoeger conducted a small pilot study of 38 overweight and obese women with PCOS. The women were randomized to receive metformin, or lifestyle change plus metformin, or lifestyle change plus placebo, or placebo alone (Fertil. Steril. 2004;82:421–9).

All groups achieved at least some weight reduction, with the most weight loss occurring among the women who received both metformin and the lifestyle intervention. Ovulation rates were not significantly different among the four groups. However, an analysis of the data suggests that weight reduction likely plays a more significant role than does metformin in the resumption of ovulation, Dr. Hoeger said.

Larger studies are still needed to fill in some of the blanks surrounding fertility treatment in obese women with PCOS, Dr. Hoeger said. In the meantime, clinicians must face the pitfalls of implementing a successful lifestyle intervention. These programs can be hard to maintain because of high dropout rates, and they are expensive to perform in a clinical setting. It's also unclear whether modest weight changes can be maintained over time, as the longest trial examining lifestyle change in PCOS followed patients for 48 weeks, she said.

TORONTO — Lifestyle treatment should be the first-line therapy for the management of fertility in obese women with polycystic ovary syndrome, according to a consensus panel of the American Society for Reproductive Medicine and the European Society for Human Reproduction.

The consensus finding is based on a review of the evidence conducted in March. This effort was part of a comprehensive review of all infertility treatment in PCOS, the results of which will be forthcoming in the near future, Dr. Kathy Hoeger said at the annual meeting of the Androgen Excess Society.

The available studies suggest that lifestyle interventions that lead to modest weight loss can improve ovulatory function in overweight women with polycystic ovary syndrome, said Dr. Hoeger, of the department of obstetrics and gynecology at the University of Rochester (N.Y.) and a participant in the March consensus meeting.

However, further study is needed on the effect of weight reduction and exercise on live-birth rates, she said. More research is also needed on the appropriate time frame for weight reduction prior to conception.

The general literature shows that lifestyle change is effective for metabolic improvement, but there are no large randomized trials for effect on ovulation induction or restoration of menstrual function. All studies published to date, however, support an improvement in reproductive function with lifestyle change in women with PCOS, she said.

Among the smaller studies that have focused on reproductive outcomes, the findings suggest that modest weight loss—about 5%–10%—can improve reproductive status. “This degree of weight loss does not generally put people into a normal [body mass index] range,” Dr. Hoeger said.

For example, in a nonrandomized study of 67 obese and anovulatory women who were offered an intensive lifestyle intervention over 6 months, there was an overall 9% reduction in starting weight, and 60 of the women resumed spontaneous ovulation. Also, 52 of the women achieved pregnancy, 18 of those spontaneously. Of the 67 women in the study, 45 achieved a live birth (Hum. Reprod. 1998;13:1502–5). In another small study, 9 of 18 women became regular ovulators following a 6-month individualized diet and exercise program. The study included infertile, anovulatory obese women with PCOS. The mean weight loss was less than in the earlier study, about 2%–5%. Resuming ovulation was closely linked with improved insulin sensitivity and reduced percentage of central body fat (J. Clin. Endocrinol. Metab. 1999;84:1470–4).

Some studies have also compared the use of diet and exercise interventions with metformin in stimulating the return of ovulation. For example, Dr. Hoeger conducted a small pilot study of 38 overweight and obese women with PCOS. The women were randomized to receive metformin, or lifestyle change plus metformin, or lifestyle change plus placebo, or placebo alone (Fertil. Steril. 2004;82:421–9).

All groups achieved at least some weight reduction, with the most weight loss occurring among the women who received both metformin and the lifestyle intervention. Ovulation rates were not significantly different among the four groups. However, an analysis of the data suggests that weight reduction likely plays a more significant role than does metformin in the resumption of ovulation, Dr. Hoeger said.

Larger studies are still needed to fill in some of the blanks surrounding fertility treatment in obese women with PCOS, Dr. Hoeger said. In the meantime, clinicians must face the pitfalls of implementing a successful lifestyle intervention. These programs can be hard to maintain because of high dropout rates, and they are expensive to perform in a clinical setting. It's also unclear whether modest weight changes can be maintained over time, as the longest trial examining lifestyle change in PCOS followed patients for 48 weeks, she said.

TORONTO — Lifestyle treatment should be the first-line therapy for the management of fertility in obese women with polycystic ovary syndrome, according to a consensus panel of the American Society for Reproductive Medicine and the European Society for Human Reproduction.

The consensus finding is based on a review of the evidence conducted in March. This effort was part of a comprehensive review of all infertility treatment in PCOS, the results of which will be forthcoming in the near future, Dr. Kathy Hoeger said at the annual meeting of the Androgen Excess Society.

The available studies suggest that lifestyle interventions that lead to modest weight loss can improve ovulatory function in overweight women with polycystic ovary syndrome, said Dr. Hoeger, of the department of obstetrics and gynecology at the University of Rochester (N.Y.) and a participant in the March consensus meeting.

However, further study is needed on the effect of weight reduction and exercise on live-birth rates, she said. More research is also needed on the appropriate time frame for weight reduction prior to conception.

The general literature shows that lifestyle change is effective for metabolic improvement, but there are no large randomized trials for effect on ovulation induction or restoration of menstrual function. All studies published to date, however, support an improvement in reproductive function with lifestyle change in women with PCOS, she said.

Among the smaller studies that have focused on reproductive outcomes, the findings suggest that modest weight loss—about 5%–10%—can improve reproductive status. “This degree of weight loss does not generally put people into a normal [body mass index] range,” Dr. Hoeger said.

For example, in a nonrandomized study of 67 obese and anovulatory women who were offered an intensive lifestyle intervention over 6 months, there was an overall 9% reduction in starting weight, and 60 of the women resumed spontaneous ovulation. Also, 52 of the women achieved pregnancy, 18 of those spontaneously. Of the 67 women in the study, 45 achieved a live birth (Hum. Reprod. 1998;13:1502–5). In another small study, 9 of 18 women became regular ovulators following a 6-month individualized diet and exercise program. The study included infertile, anovulatory obese women with PCOS. The mean weight loss was less than in the earlier study, about 2%–5%. Resuming ovulation was closely linked with improved insulin sensitivity and reduced percentage of central body fat (J. Clin. Endocrinol. Metab. 1999;84:1470–4).

Some studies have also compared the use of diet and exercise interventions with metformin in stimulating the return of ovulation. For example, Dr. Hoeger conducted a small pilot study of 38 overweight and obese women with PCOS. The women were randomized to receive metformin, or lifestyle change plus metformin, or lifestyle change plus placebo, or placebo alone (Fertil. Steril. 2004;82:421–9).

All groups achieved at least some weight reduction, with the most weight loss occurring among the women who received both metformin and the lifestyle intervention. Ovulation rates were not significantly different among the four groups. However, an analysis of the data suggests that weight reduction likely plays a more significant role than does metformin in the resumption of ovulation, Dr. Hoeger said.

Larger studies are still needed to fill in some of the blanks surrounding fertility treatment in obese women with PCOS, Dr. Hoeger said. In the meantime, clinicians must face the pitfalls of implementing a successful lifestyle intervention. These programs can be hard to maintain because of high dropout rates, and they are expensive to perform in a clinical setting. It's also unclear whether modest weight changes can be maintained over time, as the longest trial examining lifestyle change in PCOS followed patients for 48 weeks, she said.

TORONTO — Although physicians commonly prescribe oral contraceptives for women with anorexia nervosa, new research presented at the annual meeting of the Endocrine Society suggests that androgen levels are already low in these women and are further reduced by the use of oral contraceptives.

But the jury is still out on the long-term consequences for skeletal health and body composition among women with the disease, said Dr. Karen K. Miller of Massachusetts General Hospital, Boston.

Dr. Miller and her colleagues performed a study analyzing androgen levels among 217 community-dwelling women in an effort to determine the physiologic consequences of prescribing oral contraceptives to women with anorexia nervosa.

The study included four arms comprised of 137 women with anorexia nervosa who were not receiving oral contraceptives; 32 women with anorexia nervosa who were receiving oral contraceptives; 21 women of normal weight with hypothalamic amenorrhea; and 27 healthy eumenorrheic controls.

Women with anorexia nervosa all met DSM-IV criteria for anorexia nervosa, were less than 85% of ideal body weight, and all had an intense fear of gaining weight or denial of low weight.

Anorectic women not receiving oral contraceptives had been amenorrheic for at least 3 consecutive months and had not received hormonal contraceptives within the previous 3 months. Anorectic women who received oral contraceptives had to have been receiving them for at least 3 months.

All women with hypothalamic amenorrhea were 90%–110% of ideal body weight; amenorrheic for at least 3 months; had normal FSH, prolactin, testosterone, and free testosterone levels; an LH-to-FSH ratio of less than 2.5; absence of hirsutism; and no history of an eating disorder.

Healthy controls were 90%–110% of ideal body weight and eumenorrheic. Controls were excluded from the study if they had a history of amenorrhea or an eating disorder, had a history of any major medical illness, or had used oral contraceptives within the last 3 months.

The mean body mass index (BMI), percent ideal body weight, percent fat, total fat mass, and fat-free mass were all lower in the anorexia nervosa groups, compared with women who had hypothalamic amenorrhea and healthy controls.

An analysis of the androgen levels among the four groups found that total testosterone levels were lower in women with anorexia nervosa than in healthy controls. The levels of total testosterone were similar in anorectic women who received oral contraceptives and those who did not. The total testosterone levels were normal in women with hypothalamic amenorrhea, Dr. Miller said.

Free testosterone levels were lower in women with anorexia nervosa than in healthy controls, and the lowest levels occurred among women with anorexia nervosa who were receiving oral contraceptives. The levels were normal in women with hypothalamic amenorrhea.

The researchers also found that dehydroepiandrosterone (DHEAS) levels were lower only in women with anorexia nervosa receiving oral contraceptives, compared with healthy controls. DHEAS levels were normal in women with anorexia nervosa not receiving contraceptives and in women with hypothalamic amenorrhea.

Free testosterone levels were found to be predictors of bone mineral density and body composition in women with anorexia nervosa, hypothalamic amenorrhea, and healthy controls. DHEAS levels also predicted bone density, but were weaker predictors than free testosterone and did not predict fat-free mass, Dr. Miller said.

Intervention studies are now needed to determine the relationship between androgens and bone density and body composition among women with anorexia nervosa, Dr. Miller said. Studies are also needed to determine whether oral contraceptive use is harmful to skeletal health in these women, she said.

TORONTO — Although physicians commonly prescribe oral contraceptives for women with anorexia nervosa, new research presented at the annual meeting of the Endocrine Society suggests that androgen levels are already low in these women and are further reduced by the use of oral contraceptives.

But the jury is still out on the long-term consequences for skeletal health and body composition among women with the disease, said Dr. Karen K. Miller of Massachusetts General Hospital, Boston.

Dr. Miller and her colleagues performed a study analyzing androgen levels among 217 community-dwelling women in an effort to determine the physiologic consequences of prescribing oral contraceptives to women with anorexia nervosa.

The study included four arms comprised of 137 women with anorexia nervosa who were not receiving oral contraceptives; 32 women with anorexia nervosa who were receiving oral contraceptives; 21 women of normal weight with hypothalamic amenorrhea; and 27 healthy eumenorrheic controls.

Women with anorexia nervosa all met DSM-IV criteria for anorexia nervosa, were less than 85% of ideal body weight, and all had an intense fear of gaining weight or denial of low weight.

Anorectic women not receiving oral contraceptives had been amenorrheic for at least 3 consecutive months and had not received hormonal contraceptives within the previous 3 months. Anorectic women who received oral contraceptives had to have been receiving them for at least 3 months.

All women with hypothalamic amenorrhea were 90%–110% of ideal body weight; amenorrheic for at least 3 months; had normal FSH, prolactin, testosterone, and free testosterone levels; an LH-to-FSH ratio of less than 2.5; absence of hirsutism; and no history of an eating disorder.

Healthy controls were 90%–110% of ideal body weight and eumenorrheic. Controls were excluded from the study if they had a history of amenorrhea or an eating disorder, had a history of any major medical illness, or had used oral contraceptives within the last 3 months.

The mean body mass index (BMI), percent ideal body weight, percent fat, total fat mass, and fat-free mass were all lower in the anorexia nervosa groups, compared with women who had hypothalamic amenorrhea and healthy controls.

An analysis of the androgen levels among the four groups found that total testosterone levels were lower in women with anorexia nervosa than in healthy controls. The levels of total testosterone were similar in anorectic women who received oral contraceptives and those who did not. The total testosterone levels were normal in women with hypothalamic amenorrhea, Dr. Miller said.

Free testosterone levels were lower in women with anorexia nervosa than in healthy controls, and the lowest levels occurred among women with anorexia nervosa who were receiving oral contraceptives. The levels were normal in women with hypothalamic amenorrhea.

The researchers also found that dehydroepiandrosterone (DHEAS) levels were lower only in women with anorexia nervosa receiving oral contraceptives, compared with healthy controls. DHEAS levels were normal in women with anorexia nervosa not receiving contraceptives and in women with hypothalamic amenorrhea.

Free testosterone levels were found to be predictors of bone mineral density and body composition in women with anorexia nervosa, hypothalamic amenorrhea, and healthy controls. DHEAS levels also predicted bone density, but were weaker predictors than free testosterone and did not predict fat-free mass, Dr. Miller said.

Intervention studies are now needed to determine the relationship between androgens and bone density and body composition among women with anorexia nervosa, Dr. Miller said. Studies are also needed to determine whether oral contraceptive use is harmful to skeletal health in these women, she said.

TORONTO — Although physicians commonly prescribe oral contraceptives for women with anorexia nervosa, new research presented at the annual meeting of the Endocrine Society suggests that androgen levels are already low in these women and are further reduced by the use of oral contraceptives.

But the jury is still out on the long-term consequences for skeletal health and body composition among women with the disease, said Dr. Karen K. Miller of Massachusetts General Hospital, Boston.

Dr. Miller and her colleagues performed a study analyzing androgen levels among 217 community-dwelling women in an effort to determine the physiologic consequences of prescribing oral contraceptives to women with anorexia nervosa.

The study included four arms comprised of 137 women with anorexia nervosa who were not receiving oral contraceptives; 32 women with anorexia nervosa who were receiving oral contraceptives; 21 women of normal weight with hypothalamic amenorrhea; and 27 healthy eumenorrheic controls.

Women with anorexia nervosa all met DSM-IV criteria for anorexia nervosa, were less than 85% of ideal body weight, and all had an intense fear of gaining weight or denial of low weight.

Anorectic women not receiving oral contraceptives had been amenorrheic for at least 3 consecutive months and had not received hormonal contraceptives within the previous 3 months. Anorectic women who received oral contraceptives had to have been receiving them for at least 3 months.

All women with hypothalamic amenorrhea were 90%–110% of ideal body weight; amenorrheic for at least 3 months; had normal FSH, prolactin, testosterone, and free testosterone levels; an LH-to-FSH ratio of less than 2.5; absence of hirsutism; and no history of an eating disorder.

Healthy controls were 90%–110% of ideal body weight and eumenorrheic. Controls were excluded from the study if they had a history of amenorrhea or an eating disorder, had a history of any major medical illness, or had used oral contraceptives within the last 3 months.

The mean body mass index (BMI), percent ideal body weight, percent fat, total fat mass, and fat-free mass were all lower in the anorexia nervosa groups, compared with women who had hypothalamic amenorrhea and healthy controls.

An analysis of the androgen levels among the four groups found that total testosterone levels were lower in women with anorexia nervosa than in healthy controls. The levels of total testosterone were similar in anorectic women who received oral contraceptives and those who did not. The total testosterone levels were normal in women with hypothalamic amenorrhea, Dr. Miller said.

Free testosterone levels were lower in women with anorexia nervosa than in healthy controls, and the lowest levels occurred among women with anorexia nervosa who were receiving oral contraceptives. The levels were normal in women with hypothalamic amenorrhea.

The researchers also found that dehydroepiandrosterone (DHEAS) levels were lower only in women with anorexia nervosa receiving oral contraceptives, compared with healthy controls. DHEAS levels were normal in women with anorexia nervosa not receiving contraceptives and in women with hypothalamic amenorrhea.

Free testosterone levels were found to be predictors of bone mineral density and body composition in women with anorexia nervosa, hypothalamic amenorrhea, and healthy controls. DHEAS levels also predicted bone density, but were weaker predictors than free testosterone and did not predict fat-free mass, Dr. Miller said.

Intervention studies are now needed to determine the relationship between androgens and bone density and body composition among women with anorexia nervosa, Dr. Miller said. Studies are also needed to determine whether oral contraceptive use is harmful to skeletal health in these women, she said.

NEW YORK — What physicians and researchers know for sure about physical activity during pregnancy hasn't changed much since the early 1900s, James M. Pivarnik, Ph.D., said at the annual meeting of the Diabetes in Pregnancy Study Group of North America.

Recommendations from the Handbook for Prospective Mothers, published in 1913, advised pregnant women that the amount of exercise needed cannot be precisely stated, walking is the best kind of exercise, and all kinds of violent exertion should be avoided. Although today's recommendations have been more thoroughly researched, they don't provide women with many more definitive answers, said Dr. Pivarnik, director of the Center for Physical Activity and Health at Michigan State University, East Lansing.

But professional medical societies are generally becoming less conservative in their recommendations about exercise for pregnant women. For example, the American College of Obstetricians and Gynecologists has revised its recommendations three times in the last 2 decades and has moved away from strict limits on physical activity.

In 1985, ACOG released its first exercise guidelines for pregnant women, which included time limits for exercise and recommended that a woman's heart rate not exceed 140 beats per minute. However, even these early guidelines included the disclaimer that physically fit pregnant woman may tolerate a more strenuous program.

“There was actually the dispensation way back then but a lot of people just didn't follow that,” Dr. Pivarnik said.

In 1994, ACOG issued updated guidelines that were less cautious and emphasized the benefits of mild to moderate exercise at least 3 days a week. “There was more stress on the health benefits, rather than the fear,” he said.

The most recent ACOG guidelines on exercise in pregnancy were issued in 2002 and address activity among recreational and competitive athletes. Specifically, the guidelines recommend that athletes with uncomplicated pregnancies can remain active during pregnancy and should modify their routines as medically indicated. However, since information on strenuous exercise is limited, these women require close medical supervision.

And most pregnant women without medical or obstetric complications can aim to engage in 30 minutes or more of moderate exercise a day, according to the guidelines.

Guidelines issued in Canada in 2003 by the Society of Obstetricians and Gynaecologists of Canada and the Canadian Society for Exercise Physiology take an even more aggressive approach. The joint 2003 guidelines recommend that all women without contraindications should be encouraged to participate in aerobic and strength-conditioning exercises during pregnancy.

But some physicians and nurse-midwives who deal with obstetrics are not up to date on the guidelines and still recommend more conservative approaches, such as not exceeding a heart rate of 140 beats per minute, Dr. Pivarnik said. “There's no evidence that that's the way it should be done,” he said.

NEW YORK — What physicians and researchers know for sure about physical activity during pregnancy hasn't changed much since the early 1900s, James M. Pivarnik, Ph.D., said at the annual meeting of the Diabetes in Pregnancy Study Group of North America.

Recommendations from the Handbook for Prospective Mothers, published in 1913, advised pregnant women that the amount of exercise needed cannot be precisely stated, walking is the best kind of exercise, and all kinds of violent exertion should be avoided. Although today's recommendations have been more thoroughly researched, they don't provide women with many more definitive answers, said Dr. Pivarnik, director of the Center for Physical Activity and Health at Michigan State University, East Lansing.

But professional medical societies are generally becoming less conservative in their recommendations about exercise for pregnant women. For example, the American College of Obstetricians and Gynecologists has revised its recommendations three times in the last 2 decades and has moved away from strict limits on physical activity.

In 1985, ACOG released its first exercise guidelines for pregnant women, which included time limits for exercise and recommended that a woman's heart rate not exceed 140 beats per minute. However, even these early guidelines included the disclaimer that physically fit pregnant woman may tolerate a more strenuous program.

“There was actually the dispensation way back then but a lot of people just didn't follow that,” Dr. Pivarnik said.

In 1994, ACOG issued updated guidelines that were less cautious and emphasized the benefits of mild to moderate exercise at least 3 days a week. “There was more stress on the health benefits, rather than the fear,” he said.

The most recent ACOG guidelines on exercise in pregnancy were issued in 2002 and address activity among recreational and competitive athletes. Specifically, the guidelines recommend that athletes with uncomplicated pregnancies can remain active during pregnancy and should modify their routines as medically indicated. However, since information on strenuous exercise is limited, these women require close medical supervision.

And most pregnant women without medical or obstetric complications can aim to engage in 30 minutes or more of moderate exercise a day, according to the guidelines.

Guidelines issued in Canada in 2003 by the Society of Obstetricians and Gynaecologists of Canada and the Canadian Society for Exercise Physiology take an even more aggressive approach. The joint 2003 guidelines recommend that all women without contraindications should be encouraged to participate in aerobic and strength-conditioning exercises during pregnancy.

But some physicians and nurse-midwives who deal with obstetrics are not up to date on the guidelines and still recommend more conservative approaches, such as not exceeding a heart rate of 140 beats per minute, Dr. Pivarnik said. “There's no evidence that that's the way it should be done,” he said.

NEW YORK — What physicians and researchers know for sure about physical activity during pregnancy hasn't changed much since the early 1900s, James M. Pivarnik, Ph.D., said at the annual meeting of the Diabetes in Pregnancy Study Group of North America.

Recommendations from the Handbook for Prospective Mothers, published in 1913, advised pregnant women that the amount of exercise needed cannot be precisely stated, walking is the best kind of exercise, and all kinds of violent exertion should be avoided. Although today's recommendations have been more thoroughly researched, they don't provide women with many more definitive answers, said Dr. Pivarnik, director of the Center for Physical Activity and Health at Michigan State University, East Lansing.

But professional medical societies are generally becoming less conservative in their recommendations about exercise for pregnant women. For example, the American College of Obstetricians and Gynecologists has revised its recommendations three times in the last 2 decades and has moved away from strict limits on physical activity.

In 1985, ACOG released its first exercise guidelines for pregnant women, which included time limits for exercise and recommended that a woman's heart rate not exceed 140 beats per minute. However, even these early guidelines included the disclaimer that physically fit pregnant woman may tolerate a more strenuous program.

“There was actually the dispensation way back then but a lot of people just didn't follow that,” Dr. Pivarnik said.

In 1994, ACOG issued updated guidelines that were less cautious and emphasized the benefits of mild to moderate exercise at least 3 days a week. “There was more stress on the health benefits, rather than the fear,” he said.

The most recent ACOG guidelines on exercise in pregnancy were issued in 2002 and address activity among recreational and competitive athletes. Specifically, the guidelines recommend that athletes with uncomplicated pregnancies can remain active during pregnancy and should modify their routines as medically indicated. However, since information on strenuous exercise is limited, these women require close medical supervision.

And most pregnant women without medical or obstetric complications can aim to engage in 30 minutes or more of moderate exercise a day, according to the guidelines.

Guidelines issued in Canada in 2003 by the Society of Obstetricians and Gynaecologists of Canada and the Canadian Society for Exercise Physiology take an even more aggressive approach. The joint 2003 guidelines recommend that all women without contraindications should be encouraged to participate in aerobic and strength-conditioning exercises during pregnancy.

But some physicians and nurse-midwives who deal with obstetrics are not up to date on the guidelines and still recommend more conservative approaches, such as not exceeding a heart rate of 140 beats per minute, Dr. Pivarnik said. “There's no evidence that that's the way it should be done,” he said.