Alicia Ault

SAN FRANCISCO — Speaking at the insurance industry's annual meeting, an Aetna executive defended the company's performance-based physician networks, saying that they were a way to keep costs down and to let patients know which physicians offered the best and most cost-effective care.

Dr. Gerald Bishop, senior medical director for Aetna's West division, spoke at the AHIP Institute, at a conference sponsored by America's Health Insurance Plans.

Preferred provider networks have been the subject of legal challenges around the country, most recently in Massachusetts and Connecticut. Physicians have claimed that the networks use inappropriate methodology to rate their performance.

In 2007, New York Attorney General Andrew Cuomo struck a settlement with several insurers in which they agreed to publicly disclose rating methods and how much of the ratings is based on cost, and to retain an independent monitoring board to report on compliance. Aetna was one of the first insurers to sign on to that settlement, and has continued to comply, said Dr. Bishop.

He noted, for instance, that Aetna reviews and updates its provider list every 2 years and notifies each physician in writing if there has been any change in his or her status. Physicians have the opportunity to appeal if there is an error—before any data are made public, he said.

The company also encourages physicians to submit any relevant information from medical records if they have a question about the rating.

Aetna first began developing its Aexcel network in 2002, said Dr. Bishop. The goal was to mitigate rising costs, ensure patient access to specialists, and find a way to recognize the variations in costs and practices in each individual market, he said. The company found that 12 specialties represented 70% of spending on specialists and 50% of the overall spending: cardiology, cardiothoracic surgery, gastroenterology, general surgery, neurology, neurosurgery, obstetrics/gynecology, orthopedics, otolaryngology, plastic surgery, urology, and vascular surgery.

When considering which physicians were eligible for the network, Aetna looks at the number of Aetna cases managed over a 3-year period (there was a 20-case minimum). The company also uses nationally recognized performance measures to gauge clinical performance. Physicians who score statistically significantly below their peers are excluded.

The company also uses the Episode Treatment Group methodology to evaluate 3 years of claims for cost and utilization patterns. A physician is considered efficient if his or her score is greater than the mean for that specialty and that market, said Dr. Bishop.

The Aexcel network now exists in 35 markets, covering 670,000 members. Aetna members in most, though not all, those areas can log onto a secure patient Web site and see costs for various procedures and information on why his or her physician has been designated a preferred provider.

Dr. Bishop said that Aetna has determined that physicians in the Aexcel network typically perform 1%-8% more efficiently than their peers. Each client could save up to 4% of annual claim costs if all its covered workers used the network, he said.

Although some physicians have been unhappy with the designations, “amazingly few physicians balk at this,” said Dr. Bishop.

SAN FRANCISCO — Speaking at the insurance industry's annual meeting, an Aetna executive defended the company's performance-based physician networks, saying that they were a way to keep costs down and to let patients know which physicians offered the best and most cost-effective care.

Dr. Gerald Bishop, senior medical director for Aetna's West division, spoke at the AHIP Institute, at a conference sponsored by America's Health Insurance Plans.

Preferred provider networks have been the subject of legal challenges around the country, most recently in Massachusetts and Connecticut. Physicians have claimed that the networks use inappropriate methodology to rate their performance.

In 2007, New York Attorney General Andrew Cuomo struck a settlement with several insurers in which they agreed to publicly disclose rating methods and how much of the ratings is based on cost, and to retain an independent monitoring board to report on compliance. Aetna was one of the first insurers to sign on to that settlement, and has continued to comply, said Dr. Bishop.

He noted, for instance, that Aetna reviews and updates its provider list every 2 years and notifies each physician in writing if there has been any change in his or her status. Physicians have the opportunity to appeal if there is an error—before any data are made public, he said.

The company also encourages physicians to submit any relevant information from medical records if they have a question about the rating.

Aetna first began developing its Aexcel network in 2002, said Dr. Bishop. The goal was to mitigate rising costs, ensure patient access to specialists, and find a way to recognize the variations in costs and practices in each individual market, he said. The company found that 12 specialties represented 70% of spending on specialists and 50% of the overall spending: cardiology, cardiothoracic surgery, gastroenterology, general surgery, neurology, neurosurgery, obstetrics/gynecology, orthopedics, otolaryngology, plastic surgery, urology, and vascular surgery.

When considering which physicians were eligible for the network, Aetna looks at the number of Aetna cases managed over a 3-year period (there was a 20-case minimum). The company also uses nationally recognized performance measures to gauge clinical performance. Physicians who score statistically significantly below their peers are excluded.

The company also uses the Episode Treatment Group methodology to evaluate 3 years of claims for cost and utilization patterns. A physician is considered efficient if his or her score is greater than the mean for that specialty and that market, said Dr. Bishop.

The Aexcel network now exists in 35 markets, covering 670,000 members. Aetna members in most, though not all, those areas can log onto a secure patient Web site and see costs for various procedures and information on why his or her physician has been designated a preferred provider.

Dr. Bishop said that Aetna has determined that physicians in the Aexcel network typically perform 1%-8% more efficiently than their peers. Each client could save up to 4% of annual claim costs if all its covered workers used the network, he said.

Although some physicians have been unhappy with the designations, “amazingly few physicians balk at this,” said Dr. Bishop.

SAN FRANCISCO — Speaking at the insurance industry's annual meeting, an Aetna executive defended the company's performance-based physician networks, saying that they were a way to keep costs down and to let patients know which physicians offered the best and most cost-effective care.

Dr. Gerald Bishop, senior medical director for Aetna's West division, spoke at the AHIP Institute, at a conference sponsored by America's Health Insurance Plans.

Preferred provider networks have been the subject of legal challenges around the country, most recently in Massachusetts and Connecticut. Physicians have claimed that the networks use inappropriate methodology to rate their performance.

In 2007, New York Attorney General Andrew Cuomo struck a settlement with several insurers in which they agreed to publicly disclose rating methods and how much of the ratings is based on cost, and to retain an independent monitoring board to report on compliance. Aetna was one of the first insurers to sign on to that settlement, and has continued to comply, said Dr. Bishop.

He noted, for instance, that Aetna reviews and updates its provider list every 2 years and notifies each physician in writing if there has been any change in his or her status. Physicians have the opportunity to appeal if there is an error—before any data are made public, he said.

The company also encourages physicians to submit any relevant information from medical records if they have a question about the rating.

Aetna first began developing its Aexcel network in 2002, said Dr. Bishop. The goal was to mitigate rising costs, ensure patient access to specialists, and find a way to recognize the variations in costs and practices in each individual market, he said. The company found that 12 specialties represented 70% of spending on specialists and 50% of the overall spending: cardiology, cardiothoracic surgery, gastroenterology, general surgery, neurology, neurosurgery, obstetrics/gynecology, orthopedics, otolaryngology, plastic surgery, urology, and vascular surgery.

When considering which physicians were eligible for the network, Aetna looks at the number of Aetna cases managed over a 3-year period (there was a 20-case minimum). The company also uses nationally recognized performance measures to gauge clinical performance. Physicians who score statistically significantly below their peers are excluded.

The company also uses the Episode Treatment Group methodology to evaluate 3 years of claims for cost and utilization patterns. A physician is considered efficient if his or her score is greater than the mean for that specialty and that market, said Dr. Bishop.

The Aexcel network now exists in 35 markets, covering 670,000 members. Aetna members in most, though not all, those areas can log onto a secure patient Web site and see costs for various procedures and information on why his or her physician has been designated a preferred provider.

Dr. Bishop said that Aetna has determined that physicians in the Aexcel network typically perform 1%-8% more efficiently than their peers. Each client could save up to 4% of annual claim costs if all its covered workers used the network, he said.

Although some physicians have been unhappy with the designations, “amazingly few physicians balk at this,” said Dr. Bishop.

NEW ORLEANS — Getting reimbursed is the top concern for physicians who offer the human papillomavirus vaccine, according to a survey conducted by researchers at Brigham and Women's Hospital, Boston.

Using a Web-based tool, Brigham resident Emily M. Ko and her colleagues surveyed 1,488 physicians who practiced with the Partners HealthCare System from May to July 2007. The survey included physicians practicing in tertiary and community settings.

Overall, 424 physicians participated. Of these, 87 (21%) were ob.gyn.s, 196 (46%) were internists, and 104 (25%) were pediatricians. The remainder came from various specialties, including infectious disease, geriatrics, endocrinology, and emergency medicine, Dr. Ko reported in a poster at the annual meeting of the American College of Obstetricians and Gynecologists.

Among participants, 80% said they offer the HPV vaccine. That included 92% of pediatricians, 81% of ob.gyn.s, and 78% of internists. According to the researchers, male physicians were 54% less likely to provide the vaccine than were female physicians. The survey did not ask questions that would determine why some physicians might be less likely to offer the vaccine, Dr. Ko said in an interview.

However, in citing barriers to vaccination, she noted that male physicians were six times more likely than female physicians to say that vaccination would keep patients from getting routine gynecologic exams or Pap smears.

Physicians based in community hospitals were twice as likely to offer the vaccine as were their colleagues at tertiary care facilities. Primary care physicians were 14 times more likely than specialists to offer the shot.

Overall, survey participants cited reimbursement as the No. 1 hurdle to offering the vaccine.

In all, 95% of physicians said the vaccine would not promote promiscuity or decrease the use of condoms. Of the remainder, 3% were neutral on the issue, and 1.4% said that the vaccine might promote promiscuity, according to Dr. Ko.

There was no difference between genders or among specialties on the promiscuity issue. However, 7% of physicians said that parents might fear that vaccination would promote sexuality and promiscuity. This was not reported as one of the biggest barriers to vaccination, said Dr. Ko. But among pediatricians, 19% said that parental fear was a barrier, making it the third biggest obstacle to vaccination.

Dr. Ko reported no conflict of interest disclosures.

NEW ORLEANS — Getting reimbursed is the top concern for physicians who offer the human papillomavirus vaccine, according to a survey conducted by researchers at Brigham and Women's Hospital, Boston.

Using a Web-based tool, Brigham resident Emily M. Ko and her colleagues surveyed 1,488 physicians who practiced with the Partners HealthCare System from May to July 2007. The survey included physicians practicing in tertiary and community settings.

Overall, 424 physicians participated. Of these, 87 (21%) were ob.gyn.s, 196 (46%) were internists, and 104 (25%) were pediatricians. The remainder came from various specialties, including infectious disease, geriatrics, endocrinology, and emergency medicine, Dr. Ko reported in a poster at the annual meeting of the American College of Obstetricians and Gynecologists.

Among participants, 80% said they offer the HPV vaccine. That included 92% of pediatricians, 81% of ob.gyn.s, and 78% of internists. According to the researchers, male physicians were 54% less likely to provide the vaccine than were female physicians. The survey did not ask questions that would determine why some physicians might be less likely to offer the vaccine, Dr. Ko said in an interview.

However, in citing barriers to vaccination, she noted that male physicians were six times more likely than female physicians to say that vaccination would keep patients from getting routine gynecologic exams or Pap smears.

Physicians based in community hospitals were twice as likely to offer the vaccine as were their colleagues at tertiary care facilities. Primary care physicians were 14 times more likely than specialists to offer the shot.

Overall, survey participants cited reimbursement as the No. 1 hurdle to offering the vaccine.

In all, 95% of physicians said the vaccine would not promote promiscuity or decrease the use of condoms. Of the remainder, 3% were neutral on the issue, and 1.4% said that the vaccine might promote promiscuity, according to Dr. Ko.

There was no difference between genders or among specialties on the promiscuity issue. However, 7% of physicians said that parents might fear that vaccination would promote sexuality and promiscuity. This was not reported as one of the biggest barriers to vaccination, said Dr. Ko. But among pediatricians, 19% said that parental fear was a barrier, making it the third biggest obstacle to vaccination.

Dr. Ko reported no conflict of interest disclosures.

NEW ORLEANS — Getting reimbursed is the top concern for physicians who offer the human papillomavirus vaccine, according to a survey conducted by researchers at Brigham and Women's Hospital, Boston.

Using a Web-based tool, Brigham resident Emily M. Ko and her colleagues surveyed 1,488 physicians who practiced with the Partners HealthCare System from May to July 2007. The survey included physicians practicing in tertiary and community settings.

Overall, 424 physicians participated. Of these, 87 (21%) were ob.gyn.s, 196 (46%) were internists, and 104 (25%) were pediatricians. The remainder came from various specialties, including infectious disease, geriatrics, endocrinology, and emergency medicine, Dr. Ko reported in a poster at the annual meeting of the American College of Obstetricians and Gynecologists.

Among participants, 80% said they offer the HPV vaccine. That included 92% of pediatricians, 81% of ob.gyn.s, and 78% of internists. According to the researchers, male physicians were 54% less likely to provide the vaccine than were female physicians. The survey did not ask questions that would determine why some physicians might be less likely to offer the vaccine, Dr. Ko said in an interview.

However, in citing barriers to vaccination, she noted that male physicians were six times more likely than female physicians to say that vaccination would keep patients from getting routine gynecologic exams or Pap smears.

Physicians based in community hospitals were twice as likely to offer the vaccine as were their colleagues at tertiary care facilities. Primary care physicians were 14 times more likely than specialists to offer the shot.

Overall, survey participants cited reimbursement as the No. 1 hurdle to offering the vaccine.

In all, 95% of physicians said the vaccine would not promote promiscuity or decrease the use of condoms. Of the remainder, 3% were neutral on the issue, and 1.4% said that the vaccine might promote promiscuity, according to Dr. Ko.

There was no difference between genders or among specialties on the promiscuity issue. However, 7% of physicians said that parents might fear that vaccination would promote sexuality and promiscuity. This was not reported as one of the biggest barriers to vaccination, said Dr. Ko. But among pediatricians, 19% said that parental fear was a barrier, making it the third biggest obstacle to vaccination.

Dr. Ko reported no conflict of interest disclosures.

SAN FRANCISCO — Aetna's performance-based physician networks are a way to keep costs down and let patients know which physicians offered the best, most cost-effective care, according to Dr. Gerald Bishop, senior medical director for Aetna's West division.

Preferred provider networks have been the subject of legal challenges around the country. Physicians have claimed that the networks use inappropriate methodology to rate performance.

In 2007, New York Attorney General Andrew Cuomo struck a settlement with several insurers in which they agreed to publicly disclose rating methods and how much of the ratings is based on cost, and to retain an independent monitoring board to report on compliance. Aetna was one of the first insurers to sign on, and has continued to comply, said Dr. Bishop at the AHIP Institute, at a conference sponsored by America's Health Insurance Plans.

He noted that Aetna reviews and updates its provider list every 2 years and notifies each physician if there has been any change in status. Physicians have the opportunity to appeal if there is an error—before any data are made public, he said.

Aetna also encourages physicians to submit relevant information from medical records if they have a question.

Aetna first began developing its Aexcel network in 2002 to mitigate rising costs, ensure patient access to specialists, and find a way to recognize the variations in costs and practices in each market, said Dr. Bishop. Aetna found that 12 specialties represented 70% of spending on specialists and 50% of overall spending: cardiology, cardiothoracic surgery, gastroenterology, general surgery, neurology, neurosurgery, obstetrics/gynecology, orthopedics, otolaryngology, plastic surgery, urology, and vascular surgery.

When considering which physicians were eligible, Aetna looks at the number of Aetna cases managed over 3 years and uses nationally recognized performance measures to gauge clinical performance. Physicians who score statistically significantly below their peers are excluded.

The company also uses the Episode Treatment Group methodology to evaluate 3 years of claims for cost and utilization patterns. A physician is considered efficient if his or her score is greater than the mean for that specialty and market, said Dr. Bishop.

The network now exists in 35 markets, covering 670,000 members. Aetna members in most areas can log onto a secure patient Web site and see costs for various procedures and information on why his or her physician has been designated a preferred provider in the network. Dr. Bishop said Aetna has determined that physicians in the Aexcel network perform 1%-8% more efficiently than their peers. A client could save 4% of annual claim costs if its covered workers used the network, he said.

SAN FRANCISCO — Aetna's performance-based physician networks are a way to keep costs down and let patients know which physicians offered the best, most cost-effective care, according to Dr. Gerald Bishop, senior medical director for Aetna's West division.

Preferred provider networks have been the subject of legal challenges around the country. Physicians have claimed that the networks use inappropriate methodology to rate performance.

In 2007, New York Attorney General Andrew Cuomo struck a settlement with several insurers in which they agreed to publicly disclose rating methods and how much of the ratings is based on cost, and to retain an independent monitoring board to report on compliance. Aetna was one of the first insurers to sign on, and has continued to comply, said Dr. Bishop at the AHIP Institute, at a conference sponsored by America's Health Insurance Plans.

He noted that Aetna reviews and updates its provider list every 2 years and notifies each physician if there has been any change in status. Physicians have the opportunity to appeal if there is an error—before any data are made public, he said.

Aetna also encourages physicians to submit relevant information from medical records if they have a question.

Aetna first began developing its Aexcel network in 2002 to mitigate rising costs, ensure patient access to specialists, and find a way to recognize the variations in costs and practices in each market, said Dr. Bishop. Aetna found that 12 specialties represented 70% of spending on specialists and 50% of overall spending: cardiology, cardiothoracic surgery, gastroenterology, general surgery, neurology, neurosurgery, obstetrics/gynecology, orthopedics, otolaryngology, plastic surgery, urology, and vascular surgery.

When considering which physicians were eligible, Aetna looks at the number of Aetna cases managed over 3 years and uses nationally recognized performance measures to gauge clinical performance. Physicians who score statistically significantly below their peers are excluded.

The company also uses the Episode Treatment Group methodology to evaluate 3 years of claims for cost and utilization patterns. A physician is considered efficient if his or her score is greater than the mean for that specialty and market, said Dr. Bishop.

The network now exists in 35 markets, covering 670,000 members. Aetna members in most areas can log onto a secure patient Web site and see costs for various procedures and information on why his or her physician has been designated a preferred provider in the network. Dr. Bishop said Aetna has determined that physicians in the Aexcel network perform 1%-8% more efficiently than their peers. A client could save 4% of annual claim costs if its covered workers used the network, he said.

SAN FRANCISCO — Aetna's performance-based physician networks are a way to keep costs down and let patients know which physicians offered the best, most cost-effective care, according to Dr. Gerald Bishop, senior medical director for Aetna's West division.

Preferred provider networks have been the subject of legal challenges around the country. Physicians have claimed that the networks use inappropriate methodology to rate performance.

In 2007, New York Attorney General Andrew Cuomo struck a settlement with several insurers in which they agreed to publicly disclose rating methods and how much of the ratings is based on cost, and to retain an independent monitoring board to report on compliance. Aetna was one of the first insurers to sign on, and has continued to comply, said Dr. Bishop at the AHIP Institute, at a conference sponsored by America's Health Insurance Plans.

He noted that Aetna reviews and updates its provider list every 2 years and notifies each physician if there has been any change in status. Physicians have the opportunity to appeal if there is an error—before any data are made public, he said.

Aetna also encourages physicians to submit relevant information from medical records if they have a question.

Aetna first began developing its Aexcel network in 2002 to mitigate rising costs, ensure patient access to specialists, and find a way to recognize the variations in costs and practices in each market, said Dr. Bishop. Aetna found that 12 specialties represented 70% of spending on specialists and 50% of overall spending: cardiology, cardiothoracic surgery, gastroenterology, general surgery, neurology, neurosurgery, obstetrics/gynecology, orthopedics, otolaryngology, plastic surgery, urology, and vascular surgery.

When considering which physicians were eligible, Aetna looks at the number of Aetna cases managed over 3 years and uses nationally recognized performance measures to gauge clinical performance. Physicians who score statistically significantly below their peers are excluded.

The company also uses the Episode Treatment Group methodology to evaluate 3 years of claims for cost and utilization patterns. A physician is considered efficient if his or her score is greater than the mean for that specialty and market, said Dr. Bishop.

The network now exists in 35 markets, covering 670,000 members. Aetna members in most areas can log onto a secure patient Web site and see costs for various procedures and information on why his or her physician has been designated a preferred provider in the network. Dr. Bishop said Aetna has determined that physicians in the Aexcel network perform 1%-8% more efficiently than their peers. A client could save 4% of annual claim costs if its covered workers used the network, he said.

The Centers for Medicare and Medicaid Services has proposed an overall 3% increase in payments for outpatient hospital care in 2009, almost a full percent below the update for 2008. As expected, reporting on quality of care is being tied to the amount of increase hospitals and other outpatient providers will receive.

For the first time, hospitals and other recipients of payments under the outpatient system that do not report data on seven quality measures on emergency department and perioperative care will see only a 1% increase.

The proposed rule, issued in July, also outlines changes for ambulatory surgery centers (ASCs) that are part of a 4-year transition to a new payment system that began this year. In 2009, as was the case this year, ASCs would be paid 65% of the rate paid for the same service in an outpatient hospital department.

The agency estimates it will spend $29 billion in 2009 on payments to acute care hospitals, inpatient rehabilitation facilities, inpatient psychiatric facilities, long-term acute-care hospitals, community mental health centers, children's hospitals, and cancer hospitals. That's a $2 billion increase from the estimated $27 billion CMS will spend on outpatient services this year, said the agency. Payments to ambulatory surgery centers will increase from an estimated $3.5 billion in 2008 to $3.9 billion in 2009, according to CMS.

For imaging—a huge and growing portion of Medicare expenditures—CMS would make a single payment for multiple imaging procedures performed in a single hospital session, including ultrasound, computed tomography, and magnetic resonance imaging.

CMS also proposes reducing pay for some of the higher-cost device-oriented procedures: a 48% reduction in pay for the placing of left ventricular pacing add-on leads; a 3% decrease for replacing pacemakers, electrodes, or pulse generators; 4% for stent placement; and just 1% for drug-eluting stents.

CMS is proposing to more aggressively penalize hospitals and other outpatient providers that do not report quality data. Providers must report on 7 measures in 2008 and on 11 in 2009, including 4 imaging efficiency measures. In addition, the agency is seeking to reduce copayments for beneficiaries who are treated at hospitals that do not report quality data.

By law, Medicare is gradually changing the payment system so that beneficiaries will be liable for only 20% of a covered service. The coinsurance rate has varied widely over the last 8–10 years. In 2009, about 25% of services will be subject to the 20% coinsurance, up from 23% in 2008, said CMS.

For ASCs, reimbursement would decrease for 92 procedures, but increase for 2,475 procedures, according to the Ambulatory Surgery Center Association. Gastrointestinal procedures as a whole are slated for a 6% reduction, and nervous system procedures and pain management would be reduced by 3%, according to Washington Analysis, a firm that advises investors on health policy developments.

Finally, the agency said that it is proposing to create four new ambulatory payment classifications for type B emergency departments (those that offer emergency-level services but are not open 24 hours a day, 7 days a week). According to data collected by CMS, most type B emergency visits are more expensive than a clinic visit, but less expensive than a visit to a traditional emergency department. The goal is to make payment for the type B centers more reflective of actual costs. The four payment groups will be based on claims data from the type B providers.

CMS is accepting public comments on the outpatient and ASC proposals until Sept. 2 and expects to issue the final rule Nov. 1.

The Centers for Medicare and Medicaid Services has proposed an overall 3% increase in payments for outpatient hospital care in 2009, almost a full percent below the update for 2008. As expected, reporting on quality of care is being tied to the amount of increase hospitals and other outpatient providers will receive.

For the first time, hospitals and other recipients of payments under the outpatient system that do not report data on seven quality measures on emergency department and perioperative care will see only a 1% increase.

The proposed rule, issued in July, also outlines changes for ambulatory surgery centers (ASCs) that are part of a 4-year transition to a new payment system that began this year. In 2009, as was the case this year, ASCs would be paid 65% of the rate paid for the same service in an outpatient hospital department.

The agency estimates it will spend $29 billion in 2009 on payments to acute care hospitals, inpatient rehabilitation facilities, inpatient psychiatric facilities, long-term acute-care hospitals, community mental health centers, children's hospitals, and cancer hospitals. That's a $2 billion increase from the estimated $27 billion CMS will spend on outpatient services this year, said the agency. Payments to ambulatory surgery centers will increase from an estimated $3.5 billion in 2008 to $3.9 billion in 2009, according to CMS.

For imaging—a huge and growing portion of Medicare expenditures—CMS would make a single payment for multiple imaging procedures performed in a single hospital session, including ultrasound, computed tomography, and magnetic resonance imaging.

CMS also proposes reducing pay for some of the higher-cost device-oriented procedures: a 48% reduction in pay for the placing of left ventricular pacing add-on leads; a 3% decrease for replacing pacemakers, electrodes, or pulse generators; 4% for stent placement; and just 1% for drug-eluting stents.

CMS is proposing to more aggressively penalize hospitals and other outpatient providers that do not report quality data. Providers must report on 7 measures in 2008 and on 11 in 2009, including 4 imaging efficiency measures. In addition, the agency is seeking to reduce copayments for beneficiaries who are treated at hospitals that do not report quality data.

By law, Medicare is gradually changing the payment system so that beneficiaries will be liable for only 20% of a covered service. The coinsurance rate has varied widely over the last 8–10 years. In 2009, about 25% of services will be subject to the 20% coinsurance, up from 23% in 2008, said CMS.

For ASCs, reimbursement would decrease for 92 procedures, but increase for 2,475 procedures, according to the Ambulatory Surgery Center Association. Gastrointestinal procedures as a whole are slated for a 6% reduction, and nervous system procedures and pain management would be reduced by 3%, according to Washington Analysis, a firm that advises investors on health policy developments.

Finally, the agency said that it is proposing to create four new ambulatory payment classifications for type B emergency departments (those that offer emergency-level services but are not open 24 hours a day, 7 days a week). According to data collected by CMS, most type B emergency visits are more expensive than a clinic visit, but less expensive than a visit to a traditional emergency department. The goal is to make payment for the type B centers more reflective of actual costs. The four payment groups will be based on claims data from the type B providers.

CMS is accepting public comments on the outpatient and ASC proposals until Sept. 2 and expects to issue the final rule Nov. 1.

The Centers for Medicare and Medicaid Services has proposed an overall 3% increase in payments for outpatient hospital care in 2009, almost a full percent below the update for 2008. As expected, reporting on quality of care is being tied to the amount of increase hospitals and other outpatient providers will receive.

For the first time, hospitals and other recipients of payments under the outpatient system that do not report data on seven quality measures on emergency department and perioperative care will see only a 1% increase.

The proposed rule, issued in July, also outlines changes for ambulatory surgery centers (ASCs) that are part of a 4-year transition to a new payment system that began this year. In 2009, as was the case this year, ASCs would be paid 65% of the rate paid for the same service in an outpatient hospital department.

The agency estimates it will spend $29 billion in 2009 on payments to acute care hospitals, inpatient rehabilitation facilities, inpatient psychiatric facilities, long-term acute-care hospitals, community mental health centers, children's hospitals, and cancer hospitals. That's a $2 billion increase from the estimated $27 billion CMS will spend on outpatient services this year, said the agency. Payments to ambulatory surgery centers will increase from an estimated $3.5 billion in 2008 to $3.9 billion in 2009, according to CMS.

For imaging—a huge and growing portion of Medicare expenditures—CMS would make a single payment for multiple imaging procedures performed in a single hospital session, including ultrasound, computed tomography, and magnetic resonance imaging.

CMS also proposes reducing pay for some of the higher-cost device-oriented procedures: a 48% reduction in pay for the placing of left ventricular pacing add-on leads; a 3% decrease for replacing pacemakers, electrodes, or pulse generators; 4% for stent placement; and just 1% for drug-eluting stents.

CMS is proposing to more aggressively penalize hospitals and other outpatient providers that do not report quality data. Providers must report on 7 measures in 2008 and on 11 in 2009, including 4 imaging efficiency measures. In addition, the agency is seeking to reduce copayments for beneficiaries who are treated at hospitals that do not report quality data.

By law, Medicare is gradually changing the payment system so that beneficiaries will be liable for only 20% of a covered service. The coinsurance rate has varied widely over the last 8–10 years. In 2009, about 25% of services will be subject to the 20% coinsurance, up from 23% in 2008, said CMS.

For ASCs, reimbursement would decrease for 92 procedures, but increase for 2,475 procedures, according to the Ambulatory Surgery Center Association. Gastrointestinal procedures as a whole are slated for a 6% reduction, and nervous system procedures and pain management would be reduced by 3%, according to Washington Analysis, a firm that advises investors on health policy developments.

Finally, the agency said that it is proposing to create four new ambulatory payment classifications for type B emergency departments (those that offer emergency-level services but are not open 24 hours a day, 7 days a week). According to data collected by CMS, most type B emergency visits are more expensive than a clinic visit, but less expensive than a visit to a traditional emergency department. The goal is to make payment for the type B centers more reflective of actual costs. The four payment groups will be based on claims data from the type B providers.

CMS is accepting public comments on the outpatient and ASC proposals until Sept. 2 and expects to issue the final rule Nov. 1.

SAN FRANCISCO — With a new president and a likely Democratic majority in the House and Senate, conditions will be ripe for health reform in early 2009, a bipartisan group of political insiders predicts.

The Democrats who spoke at Institute 2008, a meeting sponsored by America's Health Insurance Plans, were most certain of impending change. One Republican said he was optimistic, and two of his colleagues hedged their bets.

“I think something's going to happen in the next Congress,” said former Sen. John Breaux (D-La.). Sen. Breaux noted that Congress is likely to be “dramatically different” next year.

Terry McAuliffe, longtime aide to former President Clinton and Sen. Hillary Clinton (D-N.Y.), pointed out that 100 seats are up for grabs in the House and Senate. He predicted that Democrats would take at least four to seven of the Senate seats and garner a majority in both houses of Congress.

Why is this important? Traditionally, Democrats have called for bigger reforms and more government intervention, and Democratic presidential candidate Sen. Barack Obama (D-Ill.) is following that lead, Mr. McAuliffe said.

Despite concerns over the economy, energy prices, and taxes, “health care will be the number one domestic issue” in the presidential campaign and in the Congress early next year because “it affects everybody,” he said.

“I do think health care will be still at the top of the list of things that need to get done,” agreed Sen. Breaux.

Tommy G. Thompson, who served as Health and Human Services secretary under President George W. Bush, agreed with the Democrats that health reform was likely next year. He said he was optimistic because candidates for the House and Senate and both presidential contenders were talking about reform. “That tells me that 2009 is going to be the biggest year we've ever had,” said Mr. Thompson, who is also a former governor of Wisconsin.

He said there were many pressing issues to address, including a looming shortage of physicians and nurses and the predicted bankruptcy of the Medicare Hospital Insurance Trust Fund in the next 5-10 years.

Former Sen. Bill Frist (R-Tenn.) agreed with Mr. Thompson that the Medicare trust fund would get lawmakers' attention early in the next Congress. But he said, “I'm not quite as optimistic that we'll see reform.”

Sen. Frist said he does not think health care reform will be a priority until the American people make it one. In 1993, during the last major attempt at reform, 42% of Americans said the old system needed to be scrapped; “today we're at 34%.”

And, he said, the cost of adding coverage will have to be addressed, which could create some unsettling political realities.

Dan Bartlett, who served as President George W. Bush's communications director and counselor, agreed, noting that Sen. Obama had not been discussing details of his health proposals on the campaign trail.

Like Sen. Frist, Mr. Bartlett said he did not see reform as an imperative. “I don't see the mandate coming out of this election,” he said, adding, “I think you'll see incremental change, but I don't think you'll see radical change.”

SAN FRANCISCO — With a new president and a likely Democratic majority in the House and Senate, conditions will be ripe for health reform in early 2009, a bipartisan group of political insiders predicts.

The Democrats who spoke at Institute 2008, a meeting sponsored by America's Health Insurance Plans, were most certain of impending change. One Republican said he was optimistic, and two of his colleagues hedged their bets.

“I think something's going to happen in the next Congress,” said former Sen. John Breaux (D-La.). Sen. Breaux noted that Congress is likely to be “dramatically different” next year.

Terry McAuliffe, longtime aide to former President Clinton and Sen. Hillary Clinton (D-N.Y.), pointed out that 100 seats are up for grabs in the House and Senate. He predicted that Democrats would take at least four to seven of the Senate seats and garner a majority in both houses of Congress.

Why is this important? Traditionally, Democrats have called for bigger reforms and more government intervention, and Democratic presidential candidate Sen. Barack Obama (D-Ill.) is following that lead, Mr. McAuliffe said.

Despite concerns over the economy, energy prices, and taxes, “health care will be the number one domestic issue” in the presidential campaign and in the Congress early next year because “it affects everybody,” he said.

“I do think health care will be still at the top of the list of things that need to get done,” agreed Sen. Breaux.

Tommy G. Thompson, who served as Health and Human Services secretary under President George W. Bush, agreed with the Democrats that health reform was likely next year. He said he was optimistic because candidates for the House and Senate and both presidential contenders were talking about reform. “That tells me that 2009 is going to be the biggest year we've ever had,” said Mr. Thompson, who is also a former governor of Wisconsin.

He said there were many pressing issues to address, including a looming shortage of physicians and nurses and the predicted bankruptcy of the Medicare Hospital Insurance Trust Fund in the next 5-10 years.

Former Sen. Bill Frist (R-Tenn.) agreed with Mr. Thompson that the Medicare trust fund would get lawmakers' attention early in the next Congress. But he said, “I'm not quite as optimistic that we'll see reform.”

Sen. Frist said he does not think health care reform will be a priority until the American people make it one. In 1993, during the last major attempt at reform, 42% of Americans said the old system needed to be scrapped; “today we're at 34%.”

And, he said, the cost of adding coverage will have to be addressed, which could create some unsettling political realities.

Dan Bartlett, who served as President George W. Bush's communications director and counselor, agreed, noting that Sen. Obama had not been discussing details of his health proposals on the campaign trail.

Like Sen. Frist, Mr. Bartlett said he did not see reform as an imperative. “I don't see the mandate coming out of this election,” he said, adding, “I think you'll see incremental change, but I don't think you'll see radical change.”

SAN FRANCISCO — With a new president and a likely Democratic majority in the House and Senate, conditions will be ripe for health reform in early 2009, a bipartisan group of political insiders predicts.

The Democrats who spoke at Institute 2008, a meeting sponsored by America's Health Insurance Plans, were most certain of impending change. One Republican said he was optimistic, and two of his colleagues hedged their bets.

“I think something's going to happen in the next Congress,” said former Sen. John Breaux (D-La.). Sen. Breaux noted that Congress is likely to be “dramatically different” next year.

Terry McAuliffe, longtime aide to former President Clinton and Sen. Hillary Clinton (D-N.Y.), pointed out that 100 seats are up for grabs in the House and Senate. He predicted that Democrats would take at least four to seven of the Senate seats and garner a majority in both houses of Congress.

Why is this important? Traditionally, Democrats have called for bigger reforms and more government intervention, and Democratic presidential candidate Sen. Barack Obama (D-Ill.) is following that lead, Mr. McAuliffe said.

Despite concerns over the economy, energy prices, and taxes, “health care will be the number one domestic issue” in the presidential campaign and in the Congress early next year because “it affects everybody,” he said.

“I do think health care will be still at the top of the list of things that need to get done,” agreed Sen. Breaux.

Tommy G. Thompson, who served as Health and Human Services secretary under President George W. Bush, agreed with the Democrats that health reform was likely next year. He said he was optimistic because candidates for the House and Senate and both presidential contenders were talking about reform. “That tells me that 2009 is going to be the biggest year we've ever had,” said Mr. Thompson, who is also a former governor of Wisconsin.

He said there were many pressing issues to address, including a looming shortage of physicians and nurses and the predicted bankruptcy of the Medicare Hospital Insurance Trust Fund in the next 5-10 years.

Former Sen. Bill Frist (R-Tenn.) agreed with Mr. Thompson that the Medicare trust fund would get lawmakers' attention early in the next Congress. But he said, “I'm not quite as optimistic that we'll see reform.”

Sen. Frist said he does not think health care reform will be a priority until the American people make it one. In 1993, during the last major attempt at reform, 42% of Americans said the old system needed to be scrapped; “today we're at 34%.”

And, he said, the cost of adding coverage will have to be addressed, which could create some unsettling political realities.

Dan Bartlett, who served as President George W. Bush's communications director and counselor, agreed, noting that Sen. Obama had not been discussing details of his health proposals on the campaign trail.

Like Sen. Frist, Mr. Bartlett said he did not see reform as an imperative. “I don't see the mandate coming out of this election,” he said, adding, “I think you'll see incremental change, but I don't think you'll see radical change.”

SAN FRANCISCO — Speaking at the insurance industry's annual meeting, an Aetna executive defended the company's performance-based physician networks, saying that they were a way to keep costs down and to let patients know which physicians offered the best and most cost-effective care.

Dr. Gerald Bishop, senior medical director for Aetna's West division, spoke at the AHIP Institute, at a conference sponsored by America's Health Insurance Plans.

Preferred provider networks have been the subject of legal challenges around the country, most recently in Massachusetts and Connecticut. Physicians have claimed that the networks use inappropriate methodology to rate their performance.

In 2007, New York Attorney General Andrew Cuomo struck a settlement with several insurers in which they agreed to publicly disclose rating methods and how much of the ratings is based on cost, and to retain an independent monitoring board to report on compliance. Aetna was one of the first insurers to sign on to that settlement, and has continued to comply, said Dr. Bishop. He noted, for instance, that Aetna reviews and updates its provider list every 2 years and notifies each physician in writing if there has been any change in his or her status. Physicians have the opportunity to appeal if there is an error.

Aetna first began developing its Aexcel network in 2002, said Dr. Bishop. The goal was to mitigate rising costs, ensure patient access to specialists, and find a way to recognize the variations in costs and practices in each individual market, he said. The company found that 12 specialties represented 70% of spending on specialists and 50% of the overall spending: cardiology, cardiothoracic surgery, gastroenterology, general surgery, neurology, neurosurgery, obstetrics/gynecology, orthopedics, otolaryngology, plastic surgery, urology, and vascular surgery.

When considering which physicians were eligible for the network, Aetna looks at the number of Aetna cases managed over a 3-year period (there was a 20-case minimum). The company also uses nationally recognized performance measures to gauge clinical performance. Physicians who score statistically significantly below their peers are excluded.

The company also uses the Episode Treatment Group methodology to evaluate 3 years of claims for cost and utilization patterns. A physician is considered efficient if his or her score is greater than the mean for that specialty and that market.

The Aexcel network now exists in 35 markets, covering 670,000 members. Aetna members in most, though not all, those areas can log onto a secure patient Web site and see costs for various procedures and information on why his or her physician has been designated a preferred provider in the network.

SAN FRANCISCO — Speaking at the insurance industry's annual meeting, an Aetna executive defended the company's performance-based physician networks, saying that they were a way to keep costs down and to let patients know which physicians offered the best and most cost-effective care.

Dr. Gerald Bishop, senior medical director for Aetna's West division, spoke at the AHIP Institute, at a conference sponsored by America's Health Insurance Plans.

Preferred provider networks have been the subject of legal challenges around the country, most recently in Massachusetts and Connecticut. Physicians have claimed that the networks use inappropriate methodology to rate their performance.

In 2007, New York Attorney General Andrew Cuomo struck a settlement with several insurers in which they agreed to publicly disclose rating methods and how much of the ratings is based on cost, and to retain an independent monitoring board to report on compliance. Aetna was one of the first insurers to sign on to that settlement, and has continued to comply, said Dr. Bishop. He noted, for instance, that Aetna reviews and updates its provider list every 2 years and notifies each physician in writing if there has been any change in his or her status. Physicians have the opportunity to appeal if there is an error.

Aetna first began developing its Aexcel network in 2002, said Dr. Bishop. The goal was to mitigate rising costs, ensure patient access to specialists, and find a way to recognize the variations in costs and practices in each individual market, he said. The company found that 12 specialties represented 70% of spending on specialists and 50% of the overall spending: cardiology, cardiothoracic surgery, gastroenterology, general surgery, neurology, neurosurgery, obstetrics/gynecology, orthopedics, otolaryngology, plastic surgery, urology, and vascular surgery.

When considering which physicians were eligible for the network, Aetna looks at the number of Aetna cases managed over a 3-year period (there was a 20-case minimum). The company also uses nationally recognized performance measures to gauge clinical performance. Physicians who score statistically significantly below their peers are excluded.

The company also uses the Episode Treatment Group methodology to evaluate 3 years of claims for cost and utilization patterns. A physician is considered efficient if his or her score is greater than the mean for that specialty and that market.

The Aexcel network now exists in 35 markets, covering 670,000 members. Aetna members in most, though not all, those areas can log onto a secure patient Web site and see costs for various procedures and information on why his or her physician has been designated a preferred provider in the network.

SAN FRANCISCO — Speaking at the insurance industry's annual meeting, an Aetna executive defended the company's performance-based physician networks, saying that they were a way to keep costs down and to let patients know which physicians offered the best and most cost-effective care.

Dr. Gerald Bishop, senior medical director for Aetna's West division, spoke at the AHIP Institute, at a conference sponsored by America's Health Insurance Plans.

Preferred provider networks have been the subject of legal challenges around the country, most recently in Massachusetts and Connecticut. Physicians have claimed that the networks use inappropriate methodology to rate their performance.

In 2007, New York Attorney General Andrew Cuomo struck a settlement with several insurers in which they agreed to publicly disclose rating methods and how much of the ratings is based on cost, and to retain an independent monitoring board to report on compliance. Aetna was one of the first insurers to sign on to that settlement, and has continued to comply, said Dr. Bishop. He noted, for instance, that Aetna reviews and updates its provider list every 2 years and notifies each physician in writing if there has been any change in his or her status. Physicians have the opportunity to appeal if there is an error.

Aetna first began developing its Aexcel network in 2002, said Dr. Bishop. The goal was to mitigate rising costs, ensure patient access to specialists, and find a way to recognize the variations in costs and practices in each individual market, he said. The company found that 12 specialties represented 70% of spending on specialists and 50% of the overall spending: cardiology, cardiothoracic surgery, gastroenterology, general surgery, neurology, neurosurgery, obstetrics/gynecology, orthopedics, otolaryngology, plastic surgery, urology, and vascular surgery.

When considering which physicians were eligible for the network, Aetna looks at the number of Aetna cases managed over a 3-year period (there was a 20-case minimum). The company also uses nationally recognized performance measures to gauge clinical performance. Physicians who score statistically significantly below their peers are excluded.

The company also uses the Episode Treatment Group methodology to evaluate 3 years of claims for cost and utilization patterns. A physician is considered efficient if his or her score is greater than the mean for that specialty and that market.

The Aexcel network now exists in 35 markets, covering 670,000 members. Aetna members in most, though not all, those areas can log onto a secure patient Web site and see costs for various procedures and information on why his or her physician has been designated a preferred provider in the network.

SAN FRANCISCO — Teens who underwent laparoscopic gastric banding surgery had improvements in hemoglobin A1c, triglyceride, and C-reactive protein measures, according to 6-month follow-up results for 14 patients.

The Lap-Band, made by Inamed Inc., a division of Allergan Inc., was approved by the Food and Drug Administration in 2001 for adults. It has been used off label for adolescents, but many institutions are discouraging those unapproved procedures and are urging providers instead to enroll patients at one of the three study sites, said Dr. Ilene Fennoy, who presented results from the Columbia University, New York, site at the annual meeting of the Endocrine Society.

At Columbia University, 38 adolescents aged 14–17 years have received the Lap-Band, and 14 of those have had 6 months of follow-up, said Dr. Fennoy, a pediatrician at Columbia and medical director of the comprehensive adolescent bariatric surgery program at the Morgan Stanley Children's Hospital of New York-Presbyterian. Study participants, all of whom were Tanner stage IV or V, underwent psychological evaluation and had to have demonstrated failure to lose weight after participation in a documented weight-loss program for at least 6 months, Dr. Fennoy said.

Values for the children were assigned based on references; what might be considered normal for an adult is not so for a pediatric patient, according to Dr. Fennoy. Overall, the 14 patients have lost an average of 20 pounds each. The body mass index z score declined from 2.88 to 2.69, and waist circumference declined from 145.5 cm to 132.2 cm. Hemoglobin A1c values declined from 5.59% to 5.48%, while triglycerides went from 128.9 mg/dL to 95 mg/dL. C-reactive protein levels dropped from 9.4 mg/L to 5.7 mg/L.

There were no significant differences in blood pressure.

Dr. Fennoy said that the adolescents tolerated the surgery “very well,” and returned to school within a week, but that “the hardest part for them usually is eating smaller portions.” Postoperative complications included some increased bleeding in one patient and the need to reposition a band in another. The study cohort will be followed for 5 years, Dr. Fennoy said.

Overall, “for the extremely obese adolescent, [the Lap-Band] offers the opportunity to lose significant weight, which really is not present from pharmacologic and lifestyle interventions,” she noted. Her data will be part of Allergan's application to the FDA for approval of the Lap-Band in adolescents, but the company is not funding the study, Dr. Fennoy said. She had no disclosures to report.

SAN FRANCISCO — Teens who underwent laparoscopic gastric banding surgery had improvements in hemoglobin A1c, triglyceride, and C-reactive protein measures, according to 6-month follow-up results for 14 patients.

The Lap-Band, made by Inamed Inc., a division of Allergan Inc., was approved by the Food and Drug Administration in 2001 for adults. It has been used off label for adolescents, but many institutions are discouraging those unapproved procedures and are urging providers instead to enroll patients at one of the three study sites, said Dr. Ilene Fennoy, who presented results from the Columbia University, New York, site at the annual meeting of the Endocrine Society.

At Columbia University, 38 adolescents aged 14–17 years have received the Lap-Band, and 14 of those have had 6 months of follow-up, said Dr. Fennoy, a pediatrician at Columbia and medical director of the comprehensive adolescent bariatric surgery program at the Morgan Stanley Children's Hospital of New York-Presbyterian. Study participants, all of whom were Tanner stage IV or V, underwent psychological evaluation and had to have demonstrated failure to lose weight after participation in a documented weight-loss program for at least 6 months, Dr. Fennoy said.

Values for the children were assigned based on references; what might be considered normal for an adult is not so for a pediatric patient, according to Dr. Fennoy. Overall, the 14 patients have lost an average of 20 pounds each. The body mass index z score declined from 2.88 to 2.69, and waist circumference declined from 145.5 cm to 132.2 cm. Hemoglobin A1c values declined from 5.59% to 5.48%, while triglycerides went from 128.9 mg/dL to 95 mg/dL. C-reactive protein levels dropped from 9.4 mg/L to 5.7 mg/L.

There were no significant differences in blood pressure.

Dr. Fennoy said that the adolescents tolerated the surgery “very well,” and returned to school within a week, but that “the hardest part for them usually is eating smaller portions.” Postoperative complications included some increased bleeding in one patient and the need to reposition a band in another. The study cohort will be followed for 5 years, Dr. Fennoy said.

Overall, “for the extremely obese adolescent, [the Lap-Band] offers the opportunity to lose significant weight, which really is not present from pharmacologic and lifestyle interventions,” she noted. Her data will be part of Allergan's application to the FDA for approval of the Lap-Band in adolescents, but the company is not funding the study, Dr. Fennoy said. She had no disclosures to report.

SAN FRANCISCO — Teens who underwent laparoscopic gastric banding surgery had improvements in hemoglobin A1c, triglyceride, and C-reactive protein measures, according to 6-month follow-up results for 14 patients.

The Lap-Band, made by Inamed Inc., a division of Allergan Inc., was approved by the Food and Drug Administration in 2001 for adults. It has been used off label for adolescents, but many institutions are discouraging those unapproved procedures and are urging providers instead to enroll patients at one of the three study sites, said Dr. Ilene Fennoy, who presented results from the Columbia University, New York, site at the annual meeting of the Endocrine Society.

At Columbia University, 38 adolescents aged 14–17 years have received the Lap-Band, and 14 of those have had 6 months of follow-up, said Dr. Fennoy, a pediatrician at Columbia and medical director of the comprehensive adolescent bariatric surgery program at the Morgan Stanley Children's Hospital of New York-Presbyterian. Study participants, all of whom were Tanner stage IV or V, underwent psychological evaluation and had to have demonstrated failure to lose weight after participation in a documented weight-loss program for at least 6 months, Dr. Fennoy said.

Values for the children were assigned based on references; what might be considered normal for an adult is not so for a pediatric patient, according to Dr. Fennoy. Overall, the 14 patients have lost an average of 20 pounds each. The body mass index z score declined from 2.88 to 2.69, and waist circumference declined from 145.5 cm to 132.2 cm. Hemoglobin A1c values declined from 5.59% to 5.48%, while triglycerides went from 128.9 mg/dL to 95 mg/dL. C-reactive protein levels dropped from 9.4 mg/L to 5.7 mg/L.

There were no significant differences in blood pressure.

Dr. Fennoy said that the adolescents tolerated the surgery “very well,” and returned to school within a week, but that “the hardest part for them usually is eating smaller portions.” Postoperative complications included some increased bleeding in one patient and the need to reposition a band in another. The study cohort will be followed for 5 years, Dr. Fennoy said.

Overall, “for the extremely obese adolescent, [the Lap-Band] offers the opportunity to lose significant weight, which really is not present from pharmacologic and lifestyle interventions,” she noted. Her data will be part of Allergan's application to the FDA for approval of the Lap-Band in adolescents, but the company is not funding the study, Dr. Fennoy said. She had no disclosures to report.

SAN DIEGO — As many as 18%–20% of cases of indeterminate acute liver failure may be the result of unrecognized acetaminophen toxicity, according to a presentation at the annual Digestive Disease Week.

The etiology is unknown in about 15% of cases of acute liver failure (ALF), said Dr. Niraj Khandelwal of the University of Texas, Dallas.

Using a novel assay that detects acetaminophen (APAP) protein adducts, the Acute Liver Failure Study Group had determined in a previous study that adducts were present in 7 (19%) of 36 cases diagnosed as indeterminate ALF. The APAP adduct levels were comparable with those seen in patients with known acetaminophen overdose (Gastroenterology 2006;130:687).

To further evaluate indeterminate ALF, the authors conducted a larger study using a newer assay—high-performance liquid chromatography with electrochemical detection (HPLC-EC)—that is more efficient and more sensitive, said Dr. Khandelwal.

The assays were conducted on sera from 113 patients in the ALF Study Group registry. The serum samples were taken on the first or second day after admission and were collected from 1998 to 2006.

Of the 113, there were 32 with known APAP overdose, 93 who were adduct negative, and 20 who were adduct positive (defined using a cut point of 1 nmol/mL). Of those 20 patients, 9 (45%) died or received transplants, and 11 (55%) spontaneously survived. Eight patients were given N-acetylcysteine (NAC), and six (75%) of those eight patients survived. Only 5 patients of the 11 who spontaneously survived did so without NAC.

The clinical and lab findings of the patients who had adducts equal to or greater than 1 nmol/mL were consistent with findings—including very high aminotransferases, low bilirubin, and favorable outcome—for known APAP overdose patients, most of whom were female. Of the patients in the positive adduct group, 80% were female. The median bilirubin level was 5.05 mg/dL, compared with 24.5 mg/dL for patients with negative adducts (less than or equal to 1 nmol/mL).

The study confirms previous data showing that as many as one in five patients with indeterminate ALF actually has unrecognized acetaminophen toxicity, said Dr. Khandelwal. Given these data and the lack of an adduct assay that can be used at the bedside in real time, NAC should be considered in patients with indeterminate ALF who match the biochemical profile for APAP overdose, he said.

Dr. Khandelwal said he had no disclosures to report.

SAN DIEGO — As many as 18%–20% of cases of indeterminate acute liver failure may be the result of unrecognized acetaminophen toxicity, according to a presentation at the annual Digestive Disease Week.

The etiology is unknown in about 15% of cases of acute liver failure (ALF), said Dr. Niraj Khandelwal of the University of Texas, Dallas.

Using a novel assay that detects acetaminophen (APAP) protein adducts, the Acute Liver Failure Study Group had determined in a previous study that adducts were present in 7 (19%) of 36 cases diagnosed as indeterminate ALF. The APAP adduct levels were comparable with those seen in patients with known acetaminophen overdose (Gastroenterology 2006;130:687).

To further evaluate indeterminate ALF, the authors conducted a larger study using a newer assay—high-performance liquid chromatography with electrochemical detection (HPLC-EC)—that is more efficient and more sensitive, said Dr. Khandelwal.

The assays were conducted on sera from 113 patients in the ALF Study Group registry. The serum samples were taken on the first or second day after admission and were collected from 1998 to 2006.

Of the 113, there were 32 with known APAP overdose, 93 who were adduct negative, and 20 who were adduct positive (defined using a cut point of 1 nmol/mL). Of those 20 patients, 9 (45%) died or received transplants, and 11 (55%) spontaneously survived. Eight patients were given N-acetylcysteine (NAC), and six (75%) of those eight patients survived. Only 5 patients of the 11 who spontaneously survived did so without NAC.

The clinical and lab findings of the patients who had adducts equal to or greater than 1 nmol/mL were consistent with findings—including very high aminotransferases, low bilirubin, and favorable outcome—for known APAP overdose patients, most of whom were female. Of the patients in the positive adduct group, 80% were female. The median bilirubin level was 5.05 mg/dL, compared with 24.5 mg/dL for patients with negative adducts (less than or equal to 1 nmol/mL).

The study confirms previous data showing that as many as one in five patients with indeterminate ALF actually has unrecognized acetaminophen toxicity, said Dr. Khandelwal. Given these data and the lack of an adduct assay that can be used at the bedside in real time, NAC should be considered in patients with indeterminate ALF who match the biochemical profile for APAP overdose, he said.

Dr. Khandelwal said he had no disclosures to report.

SAN DIEGO — As many as 18%–20% of cases of indeterminate acute liver failure may be the result of unrecognized acetaminophen toxicity, according to a presentation at the annual Digestive Disease Week.

The etiology is unknown in about 15% of cases of acute liver failure (ALF), said Dr. Niraj Khandelwal of the University of Texas, Dallas.

Using a novel assay that detects acetaminophen (APAP) protein adducts, the Acute Liver Failure Study Group had determined in a previous study that adducts were present in 7 (19%) of 36 cases diagnosed as indeterminate ALF. The APAP adduct levels were comparable with those seen in patients with known acetaminophen overdose (Gastroenterology 2006;130:687).

To further evaluate indeterminate ALF, the authors conducted a larger study using a newer assay—high-performance liquid chromatography with electrochemical detection (HPLC-EC)—that is more efficient and more sensitive, said Dr. Khandelwal.

The assays were conducted on sera from 113 patients in the ALF Study Group registry. The serum samples were taken on the first or second day after admission and were collected from 1998 to 2006.

Of the 113, there were 32 with known APAP overdose, 93 who were adduct negative, and 20 who were adduct positive (defined using a cut point of 1 nmol/mL). Of those 20 patients, 9 (45%) died or received transplants, and 11 (55%) spontaneously survived. Eight patients were given N-acetylcysteine (NAC), and six (75%) of those eight patients survived. Only 5 patients of the 11 who spontaneously survived did so without NAC.

The clinical and lab findings of the patients who had adducts equal to or greater than 1 nmol/mL were consistent with findings—including very high aminotransferases, low bilirubin, and favorable outcome—for known APAP overdose patients, most of whom were female. Of the patients in the positive adduct group, 80% were female. The median bilirubin level was 5.05 mg/dL, compared with 24.5 mg/dL for patients with negative adducts (less than or equal to 1 nmol/mL).

The study confirms previous data showing that as many as one in five patients with indeterminate ALF actually has unrecognized acetaminophen toxicity, said Dr. Khandelwal. Given these data and the lack of an adduct assay that can be used at the bedside in real time, NAC should be considered in patients with indeterminate ALF who match the biochemical profile for APAP overdose, he said.

Dr. Khandelwal said he had no disclosures to report.

SAN DIEGO — Adding methotrexate to infliximab was not superior to infliximab alone in Crohn's disease, according to a presentation at Digestive Disease Week.

Both drugs are effective on their own, but it was not known whether a combination approach would be more effective, said Dr. Brian Feagan, professor of medicine and professor of epidemiology and biostatistics at the University of Western Ontario, London, and director of Robarts Research Institute.

Dr. Feagan and his colleagues at 15 Canadian centers conducted a 50-week, double-blind, placebo-controlled parallel-design trial. All patients had active Crohn's disease and were randomly assigned to receive methotrexate or placebo in addition to infliximab. There were 63 patients in each group.

Both groups received intravenous infliximab at 5 mg/kg at weeks 1, 3, and 7 as well as every 8 weeks thereafter. All patients received intravenous infusions of hydrocortisone (200 mg) before infliximab.

The methotrexate group received 10 mg in week 1, 10 mg in week 2, and then 20 mg for 2 weeks, followed by 25 mg each week for the duration of the trial. Every patient received prednisone induction therapy within 6 weeks of the trial's start. Tapering of prednisone began at the study's start in a manner that ensured that all patients had discontinued by week 14.

The primary outcome was time to treatment failure, strictly defined as failure to enter prednisone-free remission at week 14 and failure to maintain remission through week 50. The analysis consisted of a survival analysis based on a log rank test for the primary analysis.

About half of the 126 patients completed to week 50. Overall, the patients were somewhat older than those who normally participate in induction studies, said Dr. Feagan, noting that the average age was 40 years. Also, the proportion of smokers was large—about 40%. The average score on the Crohn's Disease Activity Index (CDAI) was 210, despite the fact that patients were taking an average of 30 mg prednisone daily. One-quarter had received antimetabolite therapy in the past.

Overall, there was no difference between the methotrexate group and the placebo group. The induction success rate was high in both groups—76% for the methotrexate arm, and 78% for the placebo arm. At week 50, 56% of methotrexate patients and 57% of placebo patients had steroid-free remission.

There was a very high response rate—87% in both groups—in patients who had Crohn's for less than 2 years. For long-established disease, the response rate was lower, at 40% for both groups, he said.

The quality of life at the end of the study was very high—almost normal—for both groups, and there were no differences between the two arms in CDAI scores. The combination therapy was well tolerated, with slightly fewer in the methotrexate group having infections (59%, or 37 patients), compared with the placebo group (62%, or 39 patients).

There were 22 patients who had a serious adverse event in the methotrexate arm, compared to 11 for the placebo group, with the primary difference being an exacerbation of Crohn's.

Dr. Feagan concluded that the study showed a high degree of success in induction and maintenance of remission over 1 year in both treatment groups. The results mean that “our best inductive regimen is highly effective,” he said.

The study gives “a very clear message,” and that is, “if you're going to achieve very high rates of steroid-free remission in the long term you need to use both of our best agents together and you need to treat early,” Dr. Feagan said.

Dr. Feagan reported that he is a consultant for Centocor Inc., which makes and sells infliximab.

SAN DIEGO — Adding methotrexate to infliximab was not superior to infliximab alone in Crohn's disease, according to a presentation at Digestive Disease Week.

Both drugs are effective on their own, but it was not known whether a combination approach would be more effective, said Dr. Brian Feagan, professor of medicine and professor of epidemiology and biostatistics at the University of Western Ontario, London, and director of Robarts Research Institute.

Dr. Feagan and his colleagues at 15 Canadian centers conducted a 50-week, double-blind, placebo-controlled parallel-design trial. All patients had active Crohn's disease and were randomly assigned to receive methotrexate or placebo in addition to infliximab. There were 63 patients in each group.

Both groups received intravenous infliximab at 5 mg/kg at weeks 1, 3, and 7 as well as every 8 weeks thereafter. All patients received intravenous infusions of hydrocortisone (200 mg) before infliximab.

The methotrexate group received 10 mg in week 1, 10 mg in week 2, and then 20 mg for 2 weeks, followed by 25 mg each week for the duration of the trial. Every patient received prednisone induction therapy within 6 weeks of the trial's start. Tapering of prednisone began at the study's start in a manner that ensured that all patients had discontinued by week 14.

The primary outcome was time to treatment failure, strictly defined as failure to enter prednisone-free remission at week 14 and failure to maintain remission through week 50. The analysis consisted of a survival analysis based on a log rank test for the primary analysis.

About half of the 126 patients completed to week 50. Overall, the patients were somewhat older than those who normally participate in induction studies, said Dr. Feagan, noting that the average age was 40 years. Also, the proportion of smokers was large—about 40%. The average score on the Crohn's Disease Activity Index (CDAI) was 210, despite the fact that patients were taking an average of 30 mg prednisone daily. One-quarter had received antimetabolite therapy in the past.

Overall, there was no difference between the methotrexate group and the placebo group. The induction success rate was high in both groups—76% for the methotrexate arm, and 78% for the placebo arm. At week 50, 56% of methotrexate patients and 57% of placebo patients had steroid-free remission.

There was a very high response rate—87% in both groups—in patients who had Crohn's for less than 2 years. For long-established disease, the response rate was lower, at 40% for both groups, he said.

The quality of life at the end of the study was very high—almost normal—for both groups, and there were no differences between the two arms in CDAI scores. The combination therapy was well tolerated, with slightly fewer in the methotrexate group having infections (59%, or 37 patients), compared with the placebo group (62%, or 39 patients).

There were 22 patients who had a serious adverse event in the methotrexate arm, compared to 11 for the placebo group, with the primary difference being an exacerbation of Crohn's.

Dr. Feagan concluded that the study showed a high degree of success in induction and maintenance of remission over 1 year in both treatment groups. The results mean that “our best inductive regimen is highly effective,” he said.

The study gives “a very clear message,” and that is, “if you're going to achieve very high rates of steroid-free remission in the long term you need to use both of our best agents together and you need to treat early,” Dr. Feagan said.

Dr. Feagan reported that he is a consultant for Centocor Inc., which makes and sells infliximab.

SAN DIEGO — Adding methotrexate to infliximab was not superior to infliximab alone in Crohn's disease, according to a presentation at Digestive Disease Week.

Both drugs are effective on their own, but it was not known whether a combination approach would be more effective, said Dr. Brian Feagan, professor of medicine and professor of epidemiology and biostatistics at the University of Western Ontario, London, and director of Robarts Research Institute.

Dr. Feagan and his colleagues at 15 Canadian centers conducted a 50-week, double-blind, placebo-controlled parallel-design trial. All patients had active Crohn's disease and were randomly assigned to receive methotrexate or placebo in addition to infliximab. There were 63 patients in each group.

Both groups received intravenous infliximab at 5 mg/kg at weeks 1, 3, and 7 as well as every 8 weeks thereafter. All patients received intravenous infusions of hydrocortisone (200 mg) before infliximab.

The methotrexate group received 10 mg in week 1, 10 mg in week 2, and then 20 mg for 2 weeks, followed by 25 mg each week for the duration of the trial. Every patient received prednisone induction therapy within 6 weeks of the trial's start. Tapering of prednisone began at the study's start in a manner that ensured that all patients had discontinued by week 14.

The primary outcome was time to treatment failure, strictly defined as failure to enter prednisone-free remission at week 14 and failure to maintain remission through week 50. The analysis consisted of a survival analysis based on a log rank test for the primary analysis.

About half of the 126 patients completed to week 50. Overall, the patients were somewhat older than those who normally participate in induction studies, said Dr. Feagan, noting that the average age was 40 years. Also, the proportion of smokers was large—about 40%. The average score on the Crohn's Disease Activity Index (CDAI) was 210, despite the fact that patients were taking an average of 30 mg prednisone daily. One-quarter had received antimetabolite therapy in the past.

Overall, there was no difference between the methotrexate group and the placebo group. The induction success rate was high in both groups—76% for the methotrexate arm, and 78% for the placebo arm. At week 50, 56% of methotrexate patients and 57% of placebo patients had steroid-free remission.

There was a very high response rate—87% in both groups—in patients who had Crohn's for less than 2 years. For long-established disease, the response rate was lower, at 40% for both groups, he said.

The quality of life at the end of the study was very high—almost normal—for both groups, and there were no differences between the two arms in CDAI scores. The combination therapy was well tolerated, with slightly fewer in the methotrexate group having infections (59%, or 37 patients), compared with the placebo group (62%, or 39 patients).

There were 22 patients who had a serious adverse event in the methotrexate arm, compared to 11 for the placebo group, with the primary difference being an exacerbation of Crohn's.

Dr. Feagan concluded that the study showed a high degree of success in induction and maintenance of remission over 1 year in both treatment groups. The results mean that “our best inductive regimen is highly effective,” he said.

The study gives “a very clear message,” and that is, “if you're going to achieve very high rates of steroid-free remission in the long term you need to use both of our best agents together and you need to treat early,” Dr. Feagan said.

Dr. Feagan reported that he is a consultant for Centocor Inc., which makes and sells infliximab.

SAN FRANCISCO — Athletic teenage girls who are amenorrheic have higher ghrelin and lower leptin levels than do athletic girls who are eumenorrheic or girls who are nonathletic, according to a small study.

The findings could help tease out which girls are more likely to stop menstruating, study investigator Dr. Madhusmita Misra of Harvard Medical School, and a pediatric endocrinologist at MassGeneral Hospital for Children, Boston, reported at the annual meeting of the Endocrine Society.

She and her colleagues aimed to determine whether ghrelin, which stimulates appetite, and leptin, which suppresses appetite, might be related to amenorrhea in young women, especially those with intense energy expenditures and a heightened need for caloric intake. Ghrelin levels have been shown to be increased in people with anorexia nervosa, and higher levels also have been linked to impaired secretion of hormones that regulate menstrual and ovarian function.

“The hormonal factors that link energy deficit and the stopping of periods in athletes are not well characterized,” said Dr. Misra, during the meeting.

It is especially important to tease out the relationships, given that evidence suggests that amenorrhea causes infertility and early onset of low bone density, she said.

About 25% of female high school athletes experience an absence of menstruation.

Dr. Misra and colleagues enrolled 21 girls who were amenorrheic athletes, 19 eumenorrheic athletes, and 18 nonathletic controls. They were aged 12–18 years. Fasting blood was drawn to measure ghrelin, leptin, estradiol, testosterone, and follicle-stimulating hormone levels.

The two athletic groups had similar activity levels, which were higher than that for the control group of nonathletes. The athletes were 85% of ideal body weight for their age.

The amenorrheic girls weighed less and had lower body mass index scores than did eumenorrheic girls. They also had slightly disordered eating behaviors, including dieting, but no use of laxatives or medications to lose weight.

As predicted, the amenorrheic girls had lower leptin levels—half those of the other two groups—and their ghrelin levels were twice those of the other two arms. The girls with the highest ghrelin levels and lowest leptin levels also had the lowest levels of estrogen and of follicle-stimulating hormone, she said.

In an interview, Dr. Misra said that it was not clear whether these hormone disturbances existed before the onset of amenorrhea, but that she was leaning toward a hypothesis that the hormone disturbances are an adaptive response in some girls. And, these girls might have an intrinsic abnormality that causes that response in the face of energy demands.

The study was funded by the National Institutes of Health. Dr. Misra has applied to the NIH for funding of a prospective study more closely examining energy availability and its affect on hormones.

She reported no conflicts related to this study.

SAN FRANCISCO — Athletic teenage girls who are amenorrheic have higher ghrelin and lower leptin levels than do athletic girls who are eumenorrheic or girls who are nonathletic, according to a small study.

The findings could help tease out which girls are more likely to stop menstruating, study investigator Dr. Madhusmita Misra of Harvard Medical School, and a pediatric endocrinologist at MassGeneral Hospital for Children, Boston, reported at the annual meeting of the Endocrine Society.

She and her colleagues aimed to determine whether ghrelin, which stimulates appetite, and leptin, which suppresses appetite, might be related to amenorrhea in young women, especially those with intense energy expenditures and a heightened need for caloric intake. Ghrelin levels have been shown to be increased in people with anorexia nervosa, and higher levels also have been linked to impaired secretion of hormones that regulate menstrual and ovarian function.

“The hormonal factors that link energy deficit and the stopping of periods in athletes are not well characterized,” said Dr. Misra, during the meeting.

It is especially important to tease out the relationships, given that evidence suggests that amenorrhea causes infertility and early onset of low bone density, she said.

About 25% of female high school athletes experience an absence of menstruation.

Dr. Misra and colleagues enrolled 21 girls who were amenorrheic athletes, 19 eumenorrheic athletes, and 18 nonathletic controls. They were aged 12–18 years. Fasting blood was drawn to measure ghrelin, leptin, estradiol, testosterone, and follicle-stimulating hormone levels.

The two athletic groups had similar activity levels, which were higher than that for the control group of nonathletes. The athletes were 85% of ideal body weight for their age.

The amenorrheic girls weighed less and had lower body mass index scores than did eumenorrheic girls. They also had slightly disordered eating behaviors, including dieting, but no use of laxatives or medications to lose weight.

As predicted, the amenorrheic girls had lower leptin levels—half those of the other two groups—and their ghrelin levels were twice those of the other two arms. The girls with the highest ghrelin levels and lowest leptin levels also had the lowest levels of estrogen and of follicle-stimulating hormone, she said.

In an interview, Dr. Misra said that it was not clear whether these hormone disturbances existed before the onset of amenorrhea, but that she was leaning toward a hypothesis that the hormone disturbances are an adaptive response in some girls. And, these girls might have an intrinsic abnormality that causes that response in the face of energy demands.

The study was funded by the National Institutes of Health. Dr. Misra has applied to the NIH for funding of a prospective study more closely examining energy availability and its affect on hormones.

She reported no conflicts related to this study.

SAN FRANCISCO — Athletic teenage girls who are amenorrheic have higher ghrelin and lower leptin levels than do athletic girls who are eumenorrheic or girls who are nonathletic, according to a small study.

The findings could help tease out which girls are more likely to stop menstruating, study investigator Dr. Madhusmita Misra of Harvard Medical School, and a pediatric endocrinologist at MassGeneral Hospital for Children, Boston, reported at the annual meeting of the Endocrine Society.

She and her colleagues aimed to determine whether ghrelin, which stimulates appetite, and leptin, which suppresses appetite, might be related to amenorrhea in young women, especially those with intense energy expenditures and a heightened need for caloric intake. Ghrelin levels have been shown to be increased in people with anorexia nervosa, and higher levels also have been linked to impaired secretion of hormones that regulate menstrual and ovarian function.

“The hormonal factors that link energy deficit and the stopping of periods in athletes are not well characterized,” said Dr. Misra, during the meeting.

It is especially important to tease out the relationships, given that evidence suggests that amenorrhea causes infertility and early onset of low bone density, she said.

About 25% of female high school athletes experience an absence of menstruation.

Dr. Misra and colleagues enrolled 21 girls who were amenorrheic athletes, 19 eumenorrheic athletes, and 18 nonathletic controls. They were aged 12–18 years. Fasting blood was drawn to measure ghrelin, leptin, estradiol, testosterone, and follicle-stimulating hormone levels.

The two athletic groups had similar activity levels, which were higher than that for the control group of nonathletes. The athletes were 85% of ideal body weight for their age.

The amenorrheic girls weighed less and had lower body mass index scores than did eumenorrheic girls. They also had slightly disordered eating behaviors, including dieting, but no use of laxatives or medications to lose weight.

As predicted, the amenorrheic girls had lower leptin levels—half those of the other two groups—and their ghrelin levels were twice those of the other two arms. The girls with the highest ghrelin levels and lowest leptin levels also had the lowest levels of estrogen and of follicle-stimulating hormone, she said.

In an interview, Dr. Misra said that it was not clear whether these hormone disturbances existed before the onset of amenorrhea, but that she was leaning toward a hypothesis that the hormone disturbances are an adaptive response in some girls. And, these girls might have an intrinsic abnormality that causes that response in the face of energy demands.

The study was funded by the National Institutes of Health. Dr. Misra has applied to the NIH for funding of a prospective study more closely examining energy availability and its affect on hormones.

She reported no conflicts related to this study.