Mary Ellen Schneider

Hospitals are reluctant to offer physicians a portion of the savings generated by reducing clinical costs—a concept known as gainsharing—because of legal worries, D. McCarty Thornton, said during an audioconference on gainsharing sponsored by the Integrated Healthcare Association.

“It's clear, I think, that gainsharing is not on the fast track,” said Mr. Thornton, a partner with the law firm of Sonnenschein, Nath, and Rosenthal LLP, based in Washington.

In the long run, gainsharing approaches that can save money without impacting patient care are likely take hold, he said, but first hospitals need clarification from Congress, the Health and Human Services secretary, and the Office of Inspector General about what arrangements are allowed.

In 1999, the HHS Office of Inspector General issued a special advisory bulletin saying that the civil monetary penalty provision of the Social Security Act prohibits most gainsharing arrangements. Under that provision, hospitals are prohibited from making payments to physicians to reduce or limit services to Medicare and Medicaid beneficiaries. The bulletin said these types of arrangements could also trigger the antikickback provisions of the Social Security Act, which prohibit arrangements used to influence the referral of patients in federal health care programs.

“Historically, the office has been somewhat leery of gainsharing arrangements,” said Catherine A. Martin, OIG senior counsel.

Since the 1999 bulletin, the OIG has issued several advisory opinions outlining gainsharing arrangements that would be allowable. In general, before giving the green light to a gainsharing arrangement, the OIG looks for transparency and accountability, quality of care controls, and safeguards against kickbacks, Ms. Martin said.

In order to be transparent, any actions taken to save costs need to be clearly and separately identified and fully disclosed to patients. Hospitals must also put in place controls to ensure that cost savings do not result in inappropriate reduction of services. OIG officials also want to see ongoing monitoring of quality by the hospital and an independent outside reviewer, Ms. Martin said.

But OIG is not the only regulator that hospitals and physicians need to consider when embarking on gainsharing arrangements, Ms. Martin said. Hospitals and physicians must also keep from running afoul of the Stark self-referral prohibitions, which fall under the purview of the Centers for Medicare and Medicaid Services. Gainsharing arrangements must also meet Internal Revenue Service rules, and hospitals are at risk for private lawsuits, she said. But the industry is keeping an eye on two demonstration projects that test the gainsharing concept in the Medicare fee-for-service program. Both projects are set to begin this year.

The first project, which is required under the Deficit Reduction Act of 2005, will involve 6 hospitals and will focus on quality and efficiency in inpatient episodes and during the 30-day postdischarge period. The DRA provision waives civil monetary penalty restrictions that would otherwise prohibit gainsharing.

The second project will focus on physician groups and integrated delivery systems and their affiliated hospitals. The demonstration will include inpatient episodes, as well as the pre- and posthospital care over the duration of the project. This demonstration was mandated by the Medicare Modernization Act of 2003.

Participants in both demonstrations will be required to standardize quality and efficiency improvement initiatives, internal cost savings measurement, and physician payment methodology, said Lisa R. Waters, a project officer with the division of payment policy demonstrations at CMS.

Hospitals are reluctant to offer physicians a portion of the savings generated by reducing clinical costs—a concept known as gainsharing—because of legal worries, D. McCarty Thornton, said during an audioconference on gainsharing sponsored by the Integrated Healthcare Association.

“It's clear, I think, that gainsharing is not on the fast track,” said Mr. Thornton, a partner with the law firm of Sonnenschein, Nath, and Rosenthal LLP, based in Washington.

In the long run, gainsharing approaches that can save money without impacting patient care are likely take hold, he said, but first hospitals need clarification from Congress, the Health and Human Services secretary, and the Office of Inspector General about what arrangements are allowed.

In 1999, the HHS Office of Inspector General issued a special advisory bulletin saying that the civil monetary penalty provision of the Social Security Act prohibits most gainsharing arrangements. Under that provision, hospitals are prohibited from making payments to physicians to reduce or limit services to Medicare and Medicaid beneficiaries. The bulletin said these types of arrangements could also trigger the antikickback provisions of the Social Security Act, which prohibit arrangements used to influence the referral of patients in federal health care programs.

“Historically, the office has been somewhat leery of gainsharing arrangements,” said Catherine A. Martin, OIG senior counsel.

Since the 1999 bulletin, the OIG has issued several advisory opinions outlining gainsharing arrangements that would be allowable. In general, before giving the green light to a gainsharing arrangement, the OIG looks for transparency and accountability, quality of care controls, and safeguards against kickbacks, Ms. Martin said.

In order to be transparent, any actions taken to save costs need to be clearly and separately identified and fully disclosed to patients. Hospitals must also put in place controls to ensure that cost savings do not result in inappropriate reduction of services. OIG officials also want to see ongoing monitoring of quality by the hospital and an independent outside reviewer, Ms. Martin said.

But OIG is not the only regulator that hospitals and physicians need to consider when embarking on gainsharing arrangements, Ms. Martin said. Hospitals and physicians must also keep from running afoul of the Stark self-referral prohibitions, which fall under the purview of the Centers for Medicare and Medicaid Services. Gainsharing arrangements must also meet Internal Revenue Service rules, and hospitals are at risk for private lawsuits, she said. But the industry is keeping an eye on two demonstration projects that test the gainsharing concept in the Medicare fee-for-service program. Both projects are set to begin this year.

The first project, which is required under the Deficit Reduction Act of 2005, will involve 6 hospitals and will focus on quality and efficiency in inpatient episodes and during the 30-day postdischarge period. The DRA provision waives civil monetary penalty restrictions that would otherwise prohibit gainsharing.

The second project will focus on physician groups and integrated delivery systems and their affiliated hospitals. The demonstration will include inpatient episodes, as well as the pre- and posthospital care over the duration of the project. This demonstration was mandated by the Medicare Modernization Act of 2003.

Participants in both demonstrations will be required to standardize quality and efficiency improvement initiatives, internal cost savings measurement, and physician payment methodology, said Lisa R. Waters, a project officer with the division of payment policy demonstrations at CMS.

Hospitals are reluctant to offer physicians a portion of the savings generated by reducing clinical costs—a concept known as gainsharing—because of legal worries, D. McCarty Thornton, said during an audioconference on gainsharing sponsored by the Integrated Healthcare Association.

“It's clear, I think, that gainsharing is not on the fast track,” said Mr. Thornton, a partner with the law firm of Sonnenschein, Nath, and Rosenthal LLP, based in Washington.

In the long run, gainsharing approaches that can save money without impacting patient care are likely take hold, he said, but first hospitals need clarification from Congress, the Health and Human Services secretary, and the Office of Inspector General about what arrangements are allowed.

In 1999, the HHS Office of Inspector General issued a special advisory bulletin saying that the civil monetary penalty provision of the Social Security Act prohibits most gainsharing arrangements. Under that provision, hospitals are prohibited from making payments to physicians to reduce or limit services to Medicare and Medicaid beneficiaries. The bulletin said these types of arrangements could also trigger the antikickback provisions of the Social Security Act, which prohibit arrangements used to influence the referral of patients in federal health care programs.

“Historically, the office has been somewhat leery of gainsharing arrangements,” said Catherine A. Martin, OIG senior counsel.

Since the 1999 bulletin, the OIG has issued several advisory opinions outlining gainsharing arrangements that would be allowable. In general, before giving the green light to a gainsharing arrangement, the OIG looks for transparency and accountability, quality of care controls, and safeguards against kickbacks, Ms. Martin said.

In order to be transparent, any actions taken to save costs need to be clearly and separately identified and fully disclosed to patients. Hospitals must also put in place controls to ensure that cost savings do not result in inappropriate reduction of services. OIG officials also want to see ongoing monitoring of quality by the hospital and an independent outside reviewer, Ms. Martin said.

But OIG is not the only regulator that hospitals and physicians need to consider when embarking on gainsharing arrangements, Ms. Martin said. Hospitals and physicians must also keep from running afoul of the Stark self-referral prohibitions, which fall under the purview of the Centers for Medicare and Medicaid Services. Gainsharing arrangements must also meet Internal Revenue Service rules, and hospitals are at risk for private lawsuits, she said. But the industry is keeping an eye on two demonstration projects that test the gainsharing concept in the Medicare fee-for-service program. Both projects are set to begin this year.

The first project, which is required under the Deficit Reduction Act of 2005, will involve 6 hospitals and will focus on quality and efficiency in inpatient episodes and during the 30-day postdischarge period. The DRA provision waives civil monetary penalty restrictions that would otherwise prohibit gainsharing.

The second project will focus on physician groups and integrated delivery systems and their affiliated hospitals. The demonstration will include inpatient episodes, as well as the pre- and posthospital care over the duration of the project. This demonstration was mandated by the Medicare Modernization Act of 2003.

Participants in both demonstrations will be required to standardize quality and efficiency improvement initiatives, internal cost savings measurement, and physician payment methodology, said Lisa R. Waters, a project officer with the division of payment policy demonstrations at CMS.

BOSTON — A controversial ad campaign aimed at encouraging women to breast-feed has increased awareness of the importance of breast-feeding and how long to do it, according to data presented at the annual meeting of the American Public Health Association.

About 68% of women surveyed after the campaign said that the best way to feed a baby is through breast-feeding, compared with 51% polled before the campaigned was launched, according to the results of a tracking survey.

Anne Merewood, director of the Breastfeeding Center at Boston Medical Center, outlined the findings of the tracking survey. The survey examines whether attitudes about breast-feeding changed after the National Breastfeeding Awareness Campaign was launched in June 2004. Ms. Merewood was the director of the Boston-area community demonstration project, 1 of 16 community-based projects around the country that partnered with the federal government to implement the campaign at the local level.

The national campaign included television, radio, and print advertisements. The controversial television ads featured women who were far along in their pregnancies engaging in risky activities such as log rolling and riding a mechanical bull. The ad said: “You wouldn't take risks before your baby's born. Why start after?” It also stated that babies who are breast-fed are less likely to develop ear infections, respiratory illnesses, and diarrhea.

The goal of the campaign was to increase the proportion of mothers who breast-feed their babies during the early postpartum period from 69% to 75%, and from 33% to 50% after 6 months, by the year 2010. The campaign was funded by the Office of Women's Health, part of the Department of Health and Human Services.

The Ad Council, which produced the campaign, conducted a tracking survey of 70 women aged 18–34 years from April 18 to May 15, 2004, before the launch of the ads. Officials at the Ad Council also conducted a postcampaign survey of 606 women aged 18–34 years from Sept. 9 to Sept. 22, 2005.

The two surveys show that following the national campaign, more women agreed that breast-feeding is the best way to feed a baby and fewer women endorsed formula only or a combination of formula and breast-feeding as the best method.

The number of women who said that breast-feeding and formula were equivalent dropped from 29% to 20%. The proportion of women who favored a mix of breast-feeding and formula also dropped. In 2004, 16% said a combination of breast-feeding and formula was the best approach, compared with 8% in 2005.

Only a small percentage of women—4%—said that formula was the best way to feed a baby in 2004, and that figure dropped even lower in 2005 to 2%.

The Ad Council survey also polled women on what they thought was the recommended number of months to exclusively breast-feed. In 2005, 36% of women responded that exclusive breast-feeding for 6 months was recommended, compared with 26% of women in 2004.

However, there also were some contradictions in the survey data. While only 2% of women in 2005 cited formula as the best way to feed a baby, during that same time period 32% of women also stated that infant formula is just as good as breast milk. This figure is down from 50% the previous year.

“We're seeing in the data here that women think breast-feeding is better, but don't think that formula feeding is worse,” Ms. Merewood said.

Some of this disconnect may be due to the fact that women recognize the benefits of breast-feeding, but see in their own personal experiences that formula feeding didn't harm their children, Ms. Merewood said. This is a different point of view than the population-wide perspective that formula feeding carries risks, she said.

BOSTON — A controversial ad campaign aimed at encouraging women to breast-feed has increased awareness of the importance of breast-feeding and how long to do it, according to data presented at the annual meeting of the American Public Health Association.

About 68% of women surveyed after the campaign said that the best way to feed a baby is through breast-feeding, compared with 51% polled before the campaigned was launched, according to the results of a tracking survey.

Anne Merewood, director of the Breastfeeding Center at Boston Medical Center, outlined the findings of the tracking survey. The survey examines whether attitudes about breast-feeding changed after the National Breastfeeding Awareness Campaign was launched in June 2004. Ms. Merewood was the director of the Boston-area community demonstration project, 1 of 16 community-based projects around the country that partnered with the federal government to implement the campaign at the local level.

The national campaign included television, radio, and print advertisements. The controversial television ads featured women who were far along in their pregnancies engaging in risky activities such as log rolling and riding a mechanical bull. The ad said: “You wouldn't take risks before your baby's born. Why start after?” It also stated that babies who are breast-fed are less likely to develop ear infections, respiratory illnesses, and diarrhea.

The goal of the campaign was to increase the proportion of mothers who breast-feed their babies during the early postpartum period from 69% to 75%, and from 33% to 50% after 6 months, by the year 2010. The campaign was funded by the Office of Women's Health, part of the Department of Health and Human Services.

The Ad Council, which produced the campaign, conducted a tracking survey of 70 women aged 18–34 years from April 18 to May 15, 2004, before the launch of the ads. Officials at the Ad Council also conducted a postcampaign survey of 606 women aged 18–34 years from Sept. 9 to Sept. 22, 2005.

The two surveys show that following the national campaign, more women agreed that breast-feeding is the best way to feed a baby and fewer women endorsed formula only or a combination of formula and breast-feeding as the best method.

The number of women who said that breast-feeding and formula were equivalent dropped from 29% to 20%. The proportion of women who favored a mix of breast-feeding and formula also dropped. In 2004, 16% said a combination of breast-feeding and formula was the best approach, compared with 8% in 2005.

Only a small percentage of women—4%—said that formula was the best way to feed a baby in 2004, and that figure dropped even lower in 2005 to 2%.

The Ad Council survey also polled women on what they thought was the recommended number of months to exclusively breast-feed. In 2005, 36% of women responded that exclusive breast-feeding for 6 months was recommended, compared with 26% of women in 2004.

However, there also were some contradictions in the survey data. While only 2% of women in 2005 cited formula as the best way to feed a baby, during that same time period 32% of women also stated that infant formula is just as good as breast milk. This figure is down from 50% the previous year.

“We're seeing in the data here that women think breast-feeding is better, but don't think that formula feeding is worse,” Ms. Merewood said.

Some of this disconnect may be due to the fact that women recognize the benefits of breast-feeding, but see in their own personal experiences that formula feeding didn't harm their children, Ms. Merewood said. This is a different point of view than the population-wide perspective that formula feeding carries risks, she said.

BOSTON — A controversial ad campaign aimed at encouraging women to breast-feed has increased awareness of the importance of breast-feeding and how long to do it, according to data presented at the annual meeting of the American Public Health Association.

About 68% of women surveyed after the campaign said that the best way to feed a baby is through breast-feeding, compared with 51% polled before the campaigned was launched, according to the results of a tracking survey.

Anne Merewood, director of the Breastfeeding Center at Boston Medical Center, outlined the findings of the tracking survey. The survey examines whether attitudes about breast-feeding changed after the National Breastfeeding Awareness Campaign was launched in June 2004. Ms. Merewood was the director of the Boston-area community demonstration project, 1 of 16 community-based projects around the country that partnered with the federal government to implement the campaign at the local level.

The national campaign included television, radio, and print advertisements. The controversial television ads featured women who were far along in their pregnancies engaging in risky activities such as log rolling and riding a mechanical bull. The ad said: “You wouldn't take risks before your baby's born. Why start after?” It also stated that babies who are breast-fed are less likely to develop ear infections, respiratory illnesses, and diarrhea.

The goal of the campaign was to increase the proportion of mothers who breast-feed their babies during the early postpartum period from 69% to 75%, and from 33% to 50% after 6 months, by the year 2010. The campaign was funded by the Office of Women's Health, part of the Department of Health and Human Services.

The Ad Council, which produced the campaign, conducted a tracking survey of 70 women aged 18–34 years from April 18 to May 15, 2004, before the launch of the ads. Officials at the Ad Council also conducted a postcampaign survey of 606 women aged 18–34 years from Sept. 9 to Sept. 22, 2005.

The two surveys show that following the national campaign, more women agreed that breast-feeding is the best way to feed a baby and fewer women endorsed formula only or a combination of formula and breast-feeding as the best method.

The number of women who said that breast-feeding and formula were equivalent dropped from 29% to 20%. The proportion of women who favored a mix of breast-feeding and formula also dropped. In 2004, 16% said a combination of breast-feeding and formula was the best approach, compared with 8% in 2005.

Only a small percentage of women—4%—said that formula was the best way to feed a baby in 2004, and that figure dropped even lower in 2005 to 2%.

The Ad Council survey also polled women on what they thought was the recommended number of months to exclusively breast-feed. In 2005, 36% of women responded that exclusive breast-feeding for 6 months was recommended, compared with 26% of women in 2004.

However, there also were some contradictions in the survey data. While only 2% of women in 2005 cited formula as the best way to feed a baby, during that same time period 32% of women also stated that infant formula is just as good as breast milk. This figure is down from 50% the previous year.

“We're seeing in the data here that women think breast-feeding is better, but don't think that formula feeding is worse,” Ms. Merewood said.

Some of this disconnect may be due to the fact that women recognize the benefits of breast-feeding, but see in their own personal experiences that formula feeding didn't harm their children, Ms. Merewood said. This is a different point of view than the population-wide perspective that formula feeding carries risks, she said.

Hospitals are reluctant to offer physicians a portion of the savings generated by reducing clinical costs—a concept known as gainsharing—because of legal fears, D. McCarty Thornton, said during an audioconference on gainsharing sponsored by the Integrated Healthcare Association.

“It's clear, I think, that gainsharing is not on the fast track,” said Mr. Thornton, a partner with the law firm of Sonnenschein, Nath, and Rosenthal LLP, based in Washington.

In the long run, gainsharing approaches that can save money without impacting patient care are likely take hold, he said, but first hospitals need clarification from Congress, the Health and Human Services secretary, and the Office of Inspector General about what arrangements are allowed.

In 1999, the HHS Office of Inspector General issued a special advisory bulletin saying that the civil monetary penalty provision of the Social Security Act prohibits most gainsharing arrangements. Under that provision, hospitals are prohibited from making payments to physicians to reduce or limit services to Medicare and Medicaid beneficiaries. The bulletin said that these types of arrangements could also trigger the antikickback provisions of the Social Security Act, which prohibits arrangements used to influence the referral of patients in federal health care programs.

“Historically, the office has been somewhat leery of gainsharing arrangements,” said Catherine A. Martin, OIG senior counsel.

Since the 1999 bulletin, the OIG has issued a number of advisory opinions which outline gainsharing arrangements that would be allowable. In general, in order to give the green light to a gainsharing arrangement, the OIG looks for transparency and accountability, quality of care controls, and safeguards against kickbacks, Ms. Martin said.

In order to be transparent, any actions taken to save costs need to be clearly and separately identified and fully disclosed to patients. Hospitals must also put in place controls to ensure that cost savings do not result in the inappropriate reduction of services. OIG officials also want to see ongoing monitoring of quality by the hospital and an independent outside reviewer, Ms. Martin said.

But OIG is not the only regulator that hospitals and physicians need to consider when embarking on gainsharing arrangements, Ms. Martin said. Hospitals and physicians must also keep from running afoul of the Stark self-referral prohibitions, which fall under the purview of the Centers for Medicare and Medicaid Services. Gainsharing arrangements must also meet Internal Revenue Service rules, and hospitals are at risk for private lawsuits, she said.

But the industry is keeping an eye on two demonstration projects that test the gainsharing concept in the Medicare fee-for-service program. Both projects are set to begin this year.

The first project, which is required under the Deficit Reduction Act of 2005, will involve six hospitals and will focus on quality and efficiency in inpatient episodes and during the 30-day postdischarge period. The DRA provision waives civil monetary penalty restrictions that would otherwise prohibit gainsharing.

The second project will focus on physician groups and integrated delivery systems and their affiliated hospitals. The demonstration will include inpatient episodes, as well as the pre- and posthospital care over the duration of the project. This demonstration was mandated the Medicare Modernization Act of 2003.

Participants in both demonstrations will be required to standardize quality and efficiency improvement initiatives, internal cost savings measurement, and physician payment methodology, said Lisa R. Waters, a project officer with the division of payment policy demonstrations at CMS.

But CMS officials are looking to test various gainsharing models so participants will have flexibility in how they choose to target savings from reducing the time to diagnosis and treatment to improving discharge planning and care coordination.

There are some alternatives and variations on gainsharing that are occurring in the marketplace, Mr. Thornton said. For example, hospitals can move forward with nonmonetary gainsharing, in which the savings are earmarked to improve physicians' work lives by upgrading surgical suites or through better scheduling. Another option is to proceed with standard gainsharing but to carve out Medicare and Medicaid patients, who fall under federal statutes. However, the OIG has been skeptical of carve-out scenarios, Mr. Thornton said.

Hospitals are reluctant to offer physicians a portion of the savings generated by reducing clinical costs—a concept known as gainsharing—because of legal fears, D. McCarty Thornton, said during an audioconference on gainsharing sponsored by the Integrated Healthcare Association.

“It's clear, I think, that gainsharing is not on the fast track,” said Mr. Thornton, a partner with the law firm of Sonnenschein, Nath, and Rosenthal LLP, based in Washington.

In the long run, gainsharing approaches that can save money without impacting patient care are likely take hold, he said, but first hospitals need clarification from Congress, the Health and Human Services secretary, and the Office of Inspector General about what arrangements are allowed.

In 1999, the HHS Office of Inspector General issued a special advisory bulletin saying that the civil monetary penalty provision of the Social Security Act prohibits most gainsharing arrangements. Under that provision, hospitals are prohibited from making payments to physicians to reduce or limit services to Medicare and Medicaid beneficiaries. The bulletin said that these types of arrangements could also trigger the antikickback provisions of the Social Security Act, which prohibits arrangements used to influence the referral of patients in federal health care programs.

“Historically, the office has been somewhat leery of gainsharing arrangements,” said Catherine A. Martin, OIG senior counsel.

Since the 1999 bulletin, the OIG has issued a number of advisory opinions which outline gainsharing arrangements that would be allowable. In general, in order to give the green light to a gainsharing arrangement, the OIG looks for transparency and accountability, quality of care controls, and safeguards against kickbacks, Ms. Martin said.

In order to be transparent, any actions taken to save costs need to be clearly and separately identified and fully disclosed to patients. Hospitals must also put in place controls to ensure that cost savings do not result in the inappropriate reduction of services. OIG officials also want to see ongoing monitoring of quality by the hospital and an independent outside reviewer, Ms. Martin said.

But OIG is not the only regulator that hospitals and physicians need to consider when embarking on gainsharing arrangements, Ms. Martin said. Hospitals and physicians must also keep from running afoul of the Stark self-referral prohibitions, which fall under the purview of the Centers for Medicare and Medicaid Services. Gainsharing arrangements must also meet Internal Revenue Service rules, and hospitals are at risk for private lawsuits, she said.

But the industry is keeping an eye on two demonstration projects that test the gainsharing concept in the Medicare fee-for-service program. Both projects are set to begin this year.

The first project, which is required under the Deficit Reduction Act of 2005, will involve six hospitals and will focus on quality and efficiency in inpatient episodes and during the 30-day postdischarge period. The DRA provision waives civil monetary penalty restrictions that would otherwise prohibit gainsharing.

The second project will focus on physician groups and integrated delivery systems and their affiliated hospitals. The demonstration will include inpatient episodes, as well as the pre- and posthospital care over the duration of the project. This demonstration was mandated the Medicare Modernization Act of 2003.

Participants in both demonstrations will be required to standardize quality and efficiency improvement initiatives, internal cost savings measurement, and physician payment methodology, said Lisa R. Waters, a project officer with the division of payment policy demonstrations at CMS.

But CMS officials are looking to test various gainsharing models so participants will have flexibility in how they choose to target savings from reducing the time to diagnosis and treatment to improving discharge planning and care coordination.

There are some alternatives and variations on gainsharing that are occurring in the marketplace, Mr. Thornton said. For example, hospitals can move forward with nonmonetary gainsharing, in which the savings are earmarked to improve physicians' work lives by upgrading surgical suites or through better scheduling. Another option is to proceed with standard gainsharing but to carve out Medicare and Medicaid patients, who fall under federal statutes. However, the OIG has been skeptical of carve-out scenarios, Mr. Thornton said.

Hospitals are reluctant to offer physicians a portion of the savings generated by reducing clinical costs—a concept known as gainsharing—because of legal fears, D. McCarty Thornton, said during an audioconference on gainsharing sponsored by the Integrated Healthcare Association.

“It's clear, I think, that gainsharing is not on the fast track,” said Mr. Thornton, a partner with the law firm of Sonnenschein, Nath, and Rosenthal LLP, based in Washington.

In the long run, gainsharing approaches that can save money without impacting patient care are likely take hold, he said, but first hospitals need clarification from Congress, the Health and Human Services secretary, and the Office of Inspector General about what arrangements are allowed.

In 1999, the HHS Office of Inspector General issued a special advisory bulletin saying that the civil monetary penalty provision of the Social Security Act prohibits most gainsharing arrangements. Under that provision, hospitals are prohibited from making payments to physicians to reduce or limit services to Medicare and Medicaid beneficiaries. The bulletin said that these types of arrangements could also trigger the antikickback provisions of the Social Security Act, which prohibits arrangements used to influence the referral of patients in federal health care programs.

“Historically, the office has been somewhat leery of gainsharing arrangements,” said Catherine A. Martin, OIG senior counsel.

Since the 1999 bulletin, the OIG has issued a number of advisory opinions which outline gainsharing arrangements that would be allowable. In general, in order to give the green light to a gainsharing arrangement, the OIG looks for transparency and accountability, quality of care controls, and safeguards against kickbacks, Ms. Martin said.

In order to be transparent, any actions taken to save costs need to be clearly and separately identified and fully disclosed to patients. Hospitals must also put in place controls to ensure that cost savings do not result in the inappropriate reduction of services. OIG officials also want to see ongoing monitoring of quality by the hospital and an independent outside reviewer, Ms. Martin said.

But OIG is not the only regulator that hospitals and physicians need to consider when embarking on gainsharing arrangements, Ms. Martin said. Hospitals and physicians must also keep from running afoul of the Stark self-referral prohibitions, which fall under the purview of the Centers for Medicare and Medicaid Services. Gainsharing arrangements must also meet Internal Revenue Service rules, and hospitals are at risk for private lawsuits, she said.

But the industry is keeping an eye on two demonstration projects that test the gainsharing concept in the Medicare fee-for-service program. Both projects are set to begin this year.

The first project, which is required under the Deficit Reduction Act of 2005, will involve six hospitals and will focus on quality and efficiency in inpatient episodes and during the 30-day postdischarge period. The DRA provision waives civil monetary penalty restrictions that would otherwise prohibit gainsharing.

The second project will focus on physician groups and integrated delivery systems and their affiliated hospitals. The demonstration will include inpatient episodes, as well as the pre- and posthospital care over the duration of the project. This demonstration was mandated the Medicare Modernization Act of 2003.

Participants in both demonstrations will be required to standardize quality and efficiency improvement initiatives, internal cost savings measurement, and physician payment methodology, said Lisa R. Waters, a project officer with the division of payment policy demonstrations at CMS.

But CMS officials are looking to test various gainsharing models so participants will have flexibility in how they choose to target savings from reducing the time to diagnosis and treatment to improving discharge planning and care coordination.

There are some alternatives and variations on gainsharing that are occurring in the marketplace, Mr. Thornton said. For example, hospitals can move forward with nonmonetary gainsharing, in which the savings are earmarked to improve physicians' work lives by upgrading surgical suites or through better scheduling. Another option is to proceed with standard gainsharing but to carve out Medicare and Medicaid patients, who fall under federal statutes. However, the OIG has been skeptical of carve-out scenarios, Mr. Thornton said.

Hospitals are reluctant to offer physicians a portion of the savings generated by reducing clinical costs—a concept known as gainsharing—because of legal fears, D. McCarty Thornton, said during an audioconference on gainsharing sponsored by the Integrated Healthcare Association.

“It's clear, I think, that gainsharing is not on the fast track,” said Mr. Thornton, a partner with the law firm of Sonnenschein, Nath, and Rosenthal LLP, based in Washington.

In the long run, gainsharing approaches that can save money without impacting patient care are likely to take hold, he said, but first hospitals need clarification from Congress, the Health and Human Services secretary, and the Office of Inspector General about what arrangements are allowed.

In 1999, the HHS Office of Inspector General issued a special advisory bulletin saying that the civil monetary penalty provision of the Social Security Act prohibits most gainsharing arrangements. Under that provision, hospitals are prohibited from making payments to physicians to reduce or limit services to Medicare and Medicaid beneficiaries.

The bulletin said that these types of arrangements could also trigger the antikickback provisions of the Social Security Act, which prohibit arrangements used to influence the referral of patients in federal health care programs.

“Historically, the office has been somewhat leery of gainsharing arrangements,” said Catherine A. Martin, OIG senior counsel.

Since the 1999 bulletin, the OIG has issued a number of advisory opinions which outline gainsharing arrangements that would be allowable.

In general, in order to give the green light to a gainsharing arrangement, the OIG looks for transparency and accountability, quality of care controls, and safeguards against kickbacks, Ms. Martin said.

In order to be transparent, any actions taken to save costs need to be clearly and separately identified and fully disclosed to patients. Hospitals must also put in place controls to ensure that cost savings do not result in the inappropriate reduction of services. OIG officials also want to see ongoing monitoring of quality by the hospital and an independent outside reviewer, Ms. Martin said.

But OIG is not the only regulator that hospitals and physicians need to consider when embarking on gainsharing arrangements, Ms. Martin said. Hospitals and physicians must also keep from running afoul of the Stark self-referral prohibitions, which fall under the purview of the Centers for Medicare and Medicaid Services.

Gainsharing arrangements must also meet Internal Revenue Service rules, and hospitals are at risk for private lawsuits, she said.

But the industry is keeping an eye on two demonstration projects that test the gainsharing concept in the Medicare fee-for-service program. Both projects are set to begin this year.

The first project, which is required under the Deficit Reduction Act of 2005, will involve 6 hospitals and will focus on quality and efficiency in inpatient episodes and during the 30-day postdischarge period. The DRA provision waives civil monetary penalty restrictions that would otherwise prohibit gainsharing.

The second project will focus on physician groups and integrated delivery systems and their affiliated hospitals.

The demonstration will include inpatient episodes, as well as the pre- and posthospital care over the duration of the project. This demonstration was mandated the Medicare Modernization Act of 2003.

Participants in both demonstrations will be required to standardize quality and efficiency improvement initiatives, internal cost savings measurement, and physician payment methodology, said Lisa R. Waters, a project officer with the division of payment policy demonstrations at CMS.

But CMS officials are looking to test various gainsharing models so participants will have flexibility in how they choose to target savings from reducing the time to diagnosis and treatment to improving discharge planning and care coordination.

Hospitals are reluctant to offer physicians a portion of the savings generated by reducing clinical costs—a concept known as gainsharing—because of legal fears, D. McCarty Thornton, said during an audioconference on gainsharing sponsored by the Integrated Healthcare Association.

“It's clear, I think, that gainsharing is not on the fast track,” said Mr. Thornton, a partner with the law firm of Sonnenschein, Nath, and Rosenthal LLP, based in Washington.

In the long run, gainsharing approaches that can save money without impacting patient care are likely to take hold, he said, but first hospitals need clarification from Congress, the Health and Human Services secretary, and the Office of Inspector General about what arrangements are allowed.

In 1999, the HHS Office of Inspector General issued a special advisory bulletin saying that the civil monetary penalty provision of the Social Security Act prohibits most gainsharing arrangements. Under that provision, hospitals are prohibited from making payments to physicians to reduce or limit services to Medicare and Medicaid beneficiaries.

The bulletin said that these types of arrangements could also trigger the antikickback provisions of the Social Security Act, which prohibit arrangements used to influence the referral of patients in federal health care programs.

“Historically, the office has been somewhat leery of gainsharing arrangements,” said Catherine A. Martin, OIG senior counsel.

Since the 1999 bulletin, the OIG has issued a number of advisory opinions which outline gainsharing arrangements that would be allowable.

In general, in order to give the green light to a gainsharing arrangement, the OIG looks for transparency and accountability, quality of care controls, and safeguards against kickbacks, Ms. Martin said.

In order to be transparent, any actions taken to save costs need to be clearly and separately identified and fully disclosed to patients. Hospitals must also put in place controls to ensure that cost savings do not result in the inappropriate reduction of services. OIG officials also want to see ongoing monitoring of quality by the hospital and an independent outside reviewer, Ms. Martin said.

But OIG is not the only regulator that hospitals and physicians need to consider when embarking on gainsharing arrangements, Ms. Martin said. Hospitals and physicians must also keep from running afoul of the Stark self-referral prohibitions, which fall under the purview of the Centers for Medicare and Medicaid Services.

Gainsharing arrangements must also meet Internal Revenue Service rules, and hospitals are at risk for private lawsuits, she said.

But the industry is keeping an eye on two demonstration projects that test the gainsharing concept in the Medicare fee-for-service program. Both projects are set to begin this year.

The first project, which is required under the Deficit Reduction Act of 2005, will involve 6 hospitals and will focus on quality and efficiency in inpatient episodes and during the 30-day postdischarge period. The DRA provision waives civil monetary penalty restrictions that would otherwise prohibit gainsharing.

The second project will focus on physician groups and integrated delivery systems and their affiliated hospitals.

The demonstration will include inpatient episodes, as well as the pre- and posthospital care over the duration of the project. This demonstration was mandated the Medicare Modernization Act of 2003.

Participants in both demonstrations will be required to standardize quality and efficiency improvement initiatives, internal cost savings measurement, and physician payment methodology, said Lisa R. Waters, a project officer with the division of payment policy demonstrations at CMS.

But CMS officials are looking to test various gainsharing models so participants will have flexibility in how they choose to target savings from reducing the time to diagnosis and treatment to improving discharge planning and care coordination.

Hospitals are reluctant to offer physicians a portion of the savings generated by reducing clinical costs—a concept known as gainsharing—because of legal fears, D. McCarty Thornton, said during an audioconference on gainsharing sponsored by the Integrated Healthcare Association.

“It's clear, I think, that gainsharing is not on the fast track,” said Mr. Thornton, a partner with the law firm of Sonnenschein, Nath, and Rosenthal LLP, based in Washington.

In the long run, gainsharing approaches that can save money without impacting patient care are likely to take hold, he said, but first hospitals need clarification from Congress, the Health and Human Services secretary, and the Office of Inspector General about what arrangements are allowed.

In 1999, the HHS Office of Inspector General issued a special advisory bulletin saying that the civil monetary penalty provision of the Social Security Act prohibits most gainsharing arrangements. Under that provision, hospitals are prohibited from making payments to physicians to reduce or limit services to Medicare and Medicaid beneficiaries.

The bulletin said that these types of arrangements could also trigger the antikickback provisions of the Social Security Act, which prohibit arrangements used to influence the referral of patients in federal health care programs.

“Historically, the office has been somewhat leery of gainsharing arrangements,” said Catherine A. Martin, OIG senior counsel.

Since the 1999 bulletin, the OIG has issued a number of advisory opinions which outline gainsharing arrangements that would be allowable.

In general, in order to give the green light to a gainsharing arrangement, the OIG looks for transparency and accountability, quality of care controls, and safeguards against kickbacks, Ms. Martin said.

In order to be transparent, any actions taken to save costs need to be clearly and separately identified and fully disclosed to patients. Hospitals must also put in place controls to ensure that cost savings do not result in the inappropriate reduction of services. OIG officials also want to see ongoing monitoring of quality by the hospital and an independent outside reviewer, Ms. Martin said.

But OIG is not the only regulator that hospitals and physicians need to consider when embarking on gainsharing arrangements, Ms. Martin said. Hospitals and physicians must also keep from running afoul of the Stark self-referral prohibitions, which fall under the purview of the Centers for Medicare and Medicaid Services.

Gainsharing arrangements must also meet Internal Revenue Service rules, and hospitals are at risk for private lawsuits, she said.

But the industry is keeping an eye on two demonstration projects that test the gainsharing concept in the Medicare fee-for-service program. Both projects are set to begin this year.

The first project, which is required under the Deficit Reduction Act of 2005, will involve 6 hospitals and will focus on quality and efficiency in inpatient episodes and during the 30-day postdischarge period. The DRA provision waives civil monetary penalty restrictions that would otherwise prohibit gainsharing.

The second project will focus on physician groups and integrated delivery systems and their affiliated hospitals.

The demonstration will include inpatient episodes, as well as the pre- and posthospital care over the duration of the project. This demonstration was mandated the Medicare Modernization Act of 2003.

Participants in both demonstrations will be required to standardize quality and efficiency improvement initiatives, internal cost savings measurement, and physician payment methodology, said Lisa R. Waters, a project officer with the division of payment policy demonstrations at CMS.

But CMS officials are looking to test various gainsharing models so participants will have flexibility in how they choose to target savings from reducing the time to diagnosis and treatment to improving discharge planning and care coordination.

RENO, NEV. — Twenty-four-hour urinary potassium excretion is an effective clinical marker for diet quality and can be used to identify patients with poor diets, Dr. Alexander G. Logan said at the annual meeting of the American College of Nutrition.

Physicians can use 24-hour urinary potassium excretion levels of less than 60 mmol/day in men and less than 41 mmol/day in women as a cutoff point in identifying patients with poor-quality diets.

“This is a simple test that can be done in the office,” said Dr. Logan, of Mount Sinai Hospital in Toronto.

Assessing diet quality can be a difficult process, he said, and usually involves the use of 24-hour diet recall, a food diary, or a food frequency questionnaire. But measuring 24-hour urinary potassium excretion provides an objective marker that can be used in diet counseling, he said.

Dr. Logan and his colleagues enrolled 220 patients from a regional kidney stone center in Ontario. The patients, aged 18–50 years old, had idiopathic nephrolithiasis and were on unrestricted diets. Staff at the kidney center collected information on weight, height, and blood pressure. In addition, the staff collected 24-hour urine samples and administered a structured patient interview and a food frequency questionnaire. The 166-item food frequency questionnaire was used to derive the patient's diet quality score.

Dr. Logan and his colleagues found that diet quality scores increased as urinary potassium values increased. Patients who had the lowest levels of urinary potassium had an average dietary quality score of 34, compared with a score of 76 among individuals with the highest urinary potassium levels.

Individuals who had high potassium levels were also more likely to report eating more recommended foods. In addition, individuals who had a high-potassium diet reported consuming less red meat, less processed meat, less fast food, and fewer high-energy drinks, Dr. Logan said.

The researchers also examined how intermediate health outcome variables—including body mass index, blood pressure, and heart rate—were associated with urinary potassium levels. They found an inverse relationship between urinary potassium and BMI. Individuals with lower urinary potassium also had a higher BMI.

Findings related to blood pressure were mixed. Systolic blood pressure was not a factor, but there was a statistically significant drop in diastolic blood pressure among individuals with high urinary potassium. High urinary potassium was also associated with lower heart rate in the study participants.

RENO, NEV. — Twenty-four-hour urinary potassium excretion is an effective clinical marker for diet quality and can be used to identify patients with poor diets, Dr. Alexander G. Logan said at the annual meeting of the American College of Nutrition.

Physicians can use 24-hour urinary potassium excretion levels of less than 60 mmol/day in men and less than 41 mmol/day in women as a cutoff point in identifying patients with poor-quality diets.

“This is a simple test that can be done in the office,” said Dr. Logan, of Mount Sinai Hospital in Toronto.

Assessing diet quality can be a difficult process, he said, and usually involves the use of 24-hour diet recall, a food diary, or a food frequency questionnaire. But measuring 24-hour urinary potassium excretion provides an objective marker that can be used in diet counseling, he said.

Dr. Logan and his colleagues enrolled 220 patients from a regional kidney stone center in Ontario. The patients, aged 18–50 years old, had idiopathic nephrolithiasis and were on unrestricted diets. Staff at the kidney center collected information on weight, height, and blood pressure. In addition, the staff collected 24-hour urine samples and administered a structured patient interview and a food frequency questionnaire. The 166-item food frequency questionnaire was used to derive the patient's diet quality score.

Dr. Logan and his colleagues found that diet quality scores increased as urinary potassium values increased. Patients who had the lowest levels of urinary potassium had an average dietary quality score of 34, compared with a score of 76 among individuals with the highest urinary potassium levels.

Individuals who had high potassium levels were also more likely to report eating more recommended foods. In addition, individuals who had a high-potassium diet reported consuming less red meat, less processed meat, less fast food, and fewer high-energy drinks, Dr. Logan said.

The researchers also examined how intermediate health outcome variables—including body mass index, blood pressure, and heart rate—were associated with urinary potassium levels. They found an inverse relationship between urinary potassium and BMI. Individuals with lower urinary potassium also had a higher BMI.

Findings related to blood pressure were mixed. Systolic blood pressure was not a factor, but there was a statistically significant drop in diastolic blood pressure among individuals with high urinary potassium. High urinary potassium was also associated with lower heart rate in the study participants.

RENO, NEV. — Twenty-four-hour urinary potassium excretion is an effective clinical marker for diet quality and can be used to identify patients with poor diets, Dr. Alexander G. Logan said at the annual meeting of the American College of Nutrition.

Physicians can use 24-hour urinary potassium excretion levels of less than 60 mmol/day in men and less than 41 mmol/day in women as a cutoff point in identifying patients with poor-quality diets.

“This is a simple test that can be done in the office,” said Dr. Logan, of Mount Sinai Hospital in Toronto.

Assessing diet quality can be a difficult process, he said, and usually involves the use of 24-hour diet recall, a food diary, or a food frequency questionnaire. But measuring 24-hour urinary potassium excretion provides an objective marker that can be used in diet counseling, he said.

Dr. Logan and his colleagues enrolled 220 patients from a regional kidney stone center in Ontario. The patients, aged 18–50 years old, had idiopathic nephrolithiasis and were on unrestricted diets. Staff at the kidney center collected information on weight, height, and blood pressure. In addition, the staff collected 24-hour urine samples and administered a structured patient interview and a food frequency questionnaire. The 166-item food frequency questionnaire was used to derive the patient's diet quality score.

Dr. Logan and his colleagues found that diet quality scores increased as urinary potassium values increased. Patients who had the lowest levels of urinary potassium had an average dietary quality score of 34, compared with a score of 76 among individuals with the highest urinary potassium levels.

Individuals who had high potassium levels were also more likely to report eating more recommended foods. In addition, individuals who had a high-potassium diet reported consuming less red meat, less processed meat, less fast food, and fewer high-energy drinks, Dr. Logan said.

The researchers also examined how intermediate health outcome variables—including body mass index, blood pressure, and heart rate—were associated with urinary potassium levels. They found an inverse relationship between urinary potassium and BMI. Individuals with lower urinary potassium also had a higher BMI.

Findings related to blood pressure were mixed. Systolic blood pressure was not a factor, but there was a statistically significant drop in diastolic blood pressure among individuals with high urinary potassium. High urinary potassium was also associated with lower heart rate in the study participants.

RENO, NEV. — Improving patient adherence to a diet program requires an investment of time that must include providing specific weight loss goals and asking patients about their progress at every visit, Lora E. Burke, Ph.D., said at the annual meeting of the American College of Nutrition.

Checking in with patients regularly by phone is also important in maintaining compliance, though the calls do not have to be made by the physician, said Dr. Burke, who offered evidence-based tips for getting patients to stick to dietary changes.

“There is no segment of the population that is immune to nonadherence,” she said. When assessing adherence to a diet regimen, give patients permission not to be 100% compliant and acknowledge the challenges they face. It's often better to ask tactfully what a patient is doing to comply, and how, than to ask yes-or-no questions, she added.

It is critical to define weight loss goals for the patient. Patients going to a nutritionist will often say that their doctor advised them to lose weight or lower their cholesterol, but that they don't know how to begin. “Patients want very specific directions,” said Dr. Burke of the University of Pittsburgh School of Nursing.

Setting a proximal goal is a good way to motivate a patient. For example, advise substituting fresh fruit for high-salt snacks.

After the goal has been set, have the patient record it and the process for achieving it in a diary. When the patient returns for the next appointment, be sure to be positive about any progress, Dr. Burke advised at the meeting.

Whatever goals are set, practitioners dealing with patient nutrition should also take into account cultural factors and family issues. Ask patients what they are willing to do and then negotiate, she said. “There's no point asking a patient to [give up] something that he or she has no intention of giving up.”

The next step is to give patients the skills they need to make changes. Patients need to learn how to reduce fat, salt, and caloric intake by reading food labels and measuring serving sizes.

Some hospitals and cardiac rehabilitation programs offer instructions on how to cook low-fat meals, eliminate salt, and begin a physical activity program, Dr. Burke said.

Social support is critical to helping patients make dietary changes: The patient may not be the person who does the shopping or cooking in the family. Physicians should therefore get family members on board and give them a chance to hear the dietary advice first hand so that everyone understands the goals. “It's very difficult to ask patients to make these changes in isolation,” Dr. Burke said.

RENO, NEV. — Improving patient adherence to a diet program requires an investment of time that must include providing specific weight loss goals and asking patients about their progress at every visit, Lora E. Burke, Ph.D., said at the annual meeting of the American College of Nutrition.

Checking in with patients regularly by phone is also important in maintaining compliance, though the calls do not have to be made by the physician, said Dr. Burke, who offered evidence-based tips for getting patients to stick to dietary changes.

“There is no segment of the population that is immune to nonadherence,” she said. When assessing adherence to a diet regimen, give patients permission not to be 100% compliant and acknowledge the challenges they face. It's often better to ask tactfully what a patient is doing to comply, and how, than to ask yes-or-no questions, she added.

It is critical to define weight loss goals for the patient. Patients going to a nutritionist will often say that their doctor advised them to lose weight or lower their cholesterol, but that they don't know how to begin. “Patients want very specific directions,” said Dr. Burke of the University of Pittsburgh School of Nursing.

Setting a proximal goal is a good way to motivate a patient. For example, advise substituting fresh fruit for high-salt snacks.

After the goal has been set, have the patient record it and the process for achieving it in a diary. When the patient returns for the next appointment, be sure to be positive about any progress, Dr. Burke advised at the meeting.

Whatever goals are set, practitioners dealing with patient nutrition should also take into account cultural factors and family issues. Ask patients what they are willing to do and then negotiate, she said. “There's no point asking a patient to [give up] something that he or she has no intention of giving up.”

The next step is to give patients the skills they need to make changes. Patients need to learn how to reduce fat, salt, and caloric intake by reading food labels and measuring serving sizes.

Some hospitals and cardiac rehabilitation programs offer instructions on how to cook low-fat meals, eliminate salt, and begin a physical activity program, Dr. Burke said.

Social support is critical to helping patients make dietary changes: The patient may not be the person who does the shopping or cooking in the family. Physicians should therefore get family members on board and give them a chance to hear the dietary advice first hand so that everyone understands the goals. “It's very difficult to ask patients to make these changes in isolation,” Dr. Burke said.

RENO, NEV. — Improving patient adherence to a diet program requires an investment of time that must include providing specific weight loss goals and asking patients about their progress at every visit, Lora E. Burke, Ph.D., said at the annual meeting of the American College of Nutrition.

Checking in with patients regularly by phone is also important in maintaining compliance, though the calls do not have to be made by the physician, said Dr. Burke, who offered evidence-based tips for getting patients to stick to dietary changes.

“There is no segment of the population that is immune to nonadherence,” she said. When assessing adherence to a diet regimen, give patients permission not to be 100% compliant and acknowledge the challenges they face. It's often better to ask tactfully what a patient is doing to comply, and how, than to ask yes-or-no questions, she added.

It is critical to define weight loss goals for the patient. Patients going to a nutritionist will often say that their doctor advised them to lose weight or lower their cholesterol, but that they don't know how to begin. “Patients want very specific directions,” said Dr. Burke of the University of Pittsburgh School of Nursing.

Setting a proximal goal is a good way to motivate a patient. For example, advise substituting fresh fruit for high-salt snacks.

After the goal has been set, have the patient record it and the process for achieving it in a diary. When the patient returns for the next appointment, be sure to be positive about any progress, Dr. Burke advised at the meeting.

Whatever goals are set, practitioners dealing with patient nutrition should also take into account cultural factors and family issues. Ask patients what they are willing to do and then negotiate, she said. “There's no point asking a patient to [give up] something that he or she has no intention of giving up.”

The next step is to give patients the skills they need to make changes. Patients need to learn how to reduce fat, salt, and caloric intake by reading food labels and measuring serving sizes.

Some hospitals and cardiac rehabilitation programs offer instructions on how to cook low-fat meals, eliminate salt, and begin a physical activity program, Dr. Burke said.

Social support is critical to helping patients make dietary changes: The patient may not be the person who does the shopping or cooking in the family. Physicians should therefore get family members on board and give them a chance to hear the dietary advice first hand so that everyone understands the goals. “It's very difficult to ask patients to make these changes in isolation,” Dr. Burke said.

BOSTON — Screening for alcohol problems at primary care visits and in the emergency room could help in the early identification of heavy drinkers who would otherwise not seek treatment, according to a poster presented at the annual meeting of the American Public Health Association.

The Alcohol Use Disorders Identification Test (AUDIT) can quickly flag individuals with potential alcohol problems who are at higher risk for mental health and physical functioning problems, Ronda L. Dearing, Ph.D., of the State University of New York at Buffalo said in an interview.

Dr. Dearing and her colleagues at the University of Minnesota recruited 208 individuals with AUDIT scores that were above the recommended screening cutoffs (8 or above for men age 65 and under, and 7 or above for women and for men over age 65). Study participants were adults without severe cognitive impairments or psychotic disorders who had not received alcohol or drug treatment in the last year.

The participants were asked: Do you have concerns about your drinking, do you consider yourself a problem drinker, and do you consider yourself an alcoholic? Despite the fact that all the individuals enrolled in the study were potential problem drinkers, nearly two-thirds of the study participants said they did not have concerns about their drinking. About 80% said they did not consider themselves to be problem drinkers, and 78% said they were not alcoholics.

Higher scores on the AUDIT were significantly associated with poorer physical health, social functioning, and mental health on the Rand 36-Item Health Survey (SF-36). On the Brief Symptom Inventory, higher AUDIT scores were significantly associated with anxiety, somatization, psychoticism, paranoid ideation, obsessive-compulsive behavior, and depression.

BOSTON — Screening for alcohol problems at primary care visits and in the emergency room could help in the early identification of heavy drinkers who would otherwise not seek treatment, according to a poster presented at the annual meeting of the American Public Health Association.

The Alcohol Use Disorders Identification Test (AUDIT) can quickly flag individuals with potential alcohol problems who are at higher risk for mental health and physical functioning problems, Ronda L. Dearing, Ph.D., of the State University of New York at Buffalo said in an interview.

Dr. Dearing and her colleagues at the University of Minnesota recruited 208 individuals with AUDIT scores that were above the recommended screening cutoffs (8 or above for men age 65 and under, and 7 or above for women and for men over age 65). Study participants were adults without severe cognitive impairments or psychotic disorders who had not received alcohol or drug treatment in the last year.

The participants were asked: Do you have concerns about your drinking, do you consider yourself a problem drinker, and do you consider yourself an alcoholic? Despite the fact that all the individuals enrolled in the study were potential problem drinkers, nearly two-thirds of the study participants said they did not have concerns about their drinking. About 80% said they did not consider themselves to be problem drinkers, and 78% said they were not alcoholics.

Higher scores on the AUDIT were significantly associated with poorer physical health, social functioning, and mental health on the Rand 36-Item Health Survey (SF-36). On the Brief Symptom Inventory, higher AUDIT scores were significantly associated with anxiety, somatization, psychoticism, paranoid ideation, obsessive-compulsive behavior, and depression.

BOSTON — Screening for alcohol problems at primary care visits and in the emergency room could help in the early identification of heavy drinkers who would otherwise not seek treatment, according to a poster presented at the annual meeting of the American Public Health Association.

The Alcohol Use Disorders Identification Test (AUDIT) can quickly flag individuals with potential alcohol problems who are at higher risk for mental health and physical functioning problems, Ronda L. Dearing, Ph.D., of the State University of New York at Buffalo said in an interview.

Dr. Dearing and her colleagues at the University of Minnesota recruited 208 individuals with AUDIT scores that were above the recommended screening cutoffs (8 or above for men age 65 and under, and 7 or above for women and for men over age 65). Study participants were adults without severe cognitive impairments or psychotic disorders who had not received alcohol or drug treatment in the last year.

The participants were asked: Do you have concerns about your drinking, do you consider yourself a problem drinker, and do you consider yourself an alcoholic? Despite the fact that all the individuals enrolled in the study were potential problem drinkers, nearly two-thirds of the study participants said they did not have concerns about their drinking. About 80% said they did not consider themselves to be problem drinkers, and 78% said they were not alcoholics.

Higher scores on the AUDIT were significantly associated with poorer physical health, social functioning, and mental health on the Rand 36-Item Health Survey (SF-36). On the Brief Symptom Inventory, higher AUDIT scores were significantly associated with anxiety, somatization, psychoticism, paranoid ideation, obsessive-compulsive behavior, and depression.

NEW YORK — Psoriasis patients taking biologic therapies require careful monitoring, including a number of lab tests and vaccinations, Dr. Mark Lebwohl said at a meeting on medical and surgical dermatology sponsored by the Mount Sinai School of Medicine.

Seasonal flu vaccines, for example, are not mandated but are widely received by patients taking all five of the top biologics to treat psoriasis—alefacept (Amevive), efalizumab (Raptiva), adalimumab (Humira), etanercept (Enbrel), and infliximab (Remicade).

Dr. Lebwohl outlined the current consensus on proper monitoring and vaccination based on package inserts, medical literature, a survey of the medical advisory board members of the National Psoriasis Foundation, and the best practices from colleagues in other specialties.

Ideally, psoriasis patients on biologics should be given the influenza vaccine and the pneumococcal vaccine, if indicated by age, before treatment begins. However, studies have shown that there is still a healthy immune response after therapy begins, so they can be given after treatment is initiated as well, said Dr. Lebwohl, professor and chairman of the department of dermatology at Mount Sinai, in New York.

Tuberculosis tests are not mandated but are widely performed at baseline for alefacept and efalizumab and are recommended by most physicians at baseline for etanercept. TB tests are mandatory at baseline when treating patients with adalimumab and infliximab, Dr. Lebwohl said. The current recommendations from the Centers for Disease Control and Prevention call for TB testing before starting patients on all tumor necrosis factor-α blockers.

At follow-up, TB tests are widely performed annually for those on adalimumab, etanercept, and infliximab.

For patients who have had a bacille Calmette-Guérin (BCG) vaccine that could mask the presence of TB, Dr. Lebwohl recommends foregoing the standard purified protein derivative (PPD) TB skin test and instead using the QuantiFERON-TB Gold test. It specifically excludes the antigens that are in BCG.

“BCG does not interfere with this test,” he said.

The QuantiFERON test eliminates the reading bias, does not require a 48-hour follow-up visit, and has no booster effect. The downside is that it does require a blood draw and costs about $90. The test is not more specific or sensitive than the PPD test, he said, but with BCG-treated patients it is certainly more specific.

Obtaining CD4 counts is mandatory for alefacept at baseline and every 2 weeks thereafter.

A complete blood count plus platelet counts are mandatory at baseline for alefacept and efalizumab and are recommended by most physicians for adalimumab, etanercept, and infliximab. At follow-up, the test is generally recommended for all five.

The package insert for efalizumab shows that 8 out of 2,700 patients taking the drug experienced significant thrombocytopenia, which resolved in most patients in 35–112 days. Overall, the onset of platelet decline occurred 2–3 months after the first dose of efalizumab.

In his practice, Dr. Lebwohl checks platelet counts monthly for the first 3 months and every 3 months thereafter. Some evidence suggests the need to check platelets more often—every month for the first 6 months—“but the bottom line is that if you check your bloods for the first 3 months you're not likely to run into trouble with this,” he said.

Chemistry panels plus liver function tests are mandatory at baseline for infliximab and are widely performed but not mandated for alefacept, efalizumab, adalimumab, and etanercept. Annual follow-up is widely performed for most of the biologics and is recommended before infusions of infliximab, but there was not agreement about how often the follow-up should be performed.

Antinuclear antibody (ANA) tests are recommended at baseline by many physicians for adalimumab, etanercept, and infliximab.

The consensus among psoriasis experts, however, is that there is no reason to check ANA at follow-up because patients are supposed to develop ANAs over the course of treatment and it should not be a reason to stop the drug, he said.

“We know that autoimmunity occurs,” Dr. Lebwohl said. “There is no question that we get more ANAs in patients treated with TNF-α blockers.”

Of the few patients who have developed drug-induced lupus, the ANA is the most common change. But a fair number of papers also are emerging on the treatment of lupus with TNF-α blockers (Arthritis Rheum. 2002;46:1408–9).

If there are no other signs of lupus, a positive ANA should not prevent physicians from treating the patient with a TNF-α blocker, Dr. Lebwohl said.

Over the past year, Dr. Lebwohl has been a consultant and speaker for, or had pending consulting agreements with, a number of drug companies, including Abbott, Amgen, Astellas, Centocor, Connetics, Genentech, Novartis, and Warner Chilcott. He also has served as a speaker for Allergan.

Patients should be given the influenza vaccine and the pneumococcal vaccine before treatment begins. DR. LEBWOHL

NEW YORK — Psoriasis patients taking biologic therapies require careful monitoring, including a number of lab tests and vaccinations, Dr. Mark Lebwohl said at a meeting on medical and surgical dermatology sponsored by the Mount Sinai School of Medicine.

Seasonal flu vaccines, for example, are not mandated but are widely received by patients taking all five of the top biologics to treat psoriasis—alefacept (Amevive), efalizumab (Raptiva), adalimumab (Humira), etanercept (Enbrel), and infliximab (Remicade).

Dr. Lebwohl outlined the current consensus on proper monitoring and vaccination based on package inserts, medical literature, a survey of the medical advisory board members of the National Psoriasis Foundation, and the best practices from colleagues in other specialties.

Ideally, psoriasis patients on biologics should be given the influenza vaccine and the pneumococcal vaccine, if indicated by age, before treatment begins. However, studies have shown that there is still a healthy immune response after therapy begins, so they can be given after treatment is initiated as well, said Dr. Lebwohl, professor and chairman of the department of dermatology at Mount Sinai, in New York.

Tuberculosis tests are not mandated but are widely performed at baseline for alefacept and efalizumab and are recommended by most physicians at baseline for etanercept. TB tests are mandatory at baseline when treating patients with adalimumab and infliximab, Dr. Lebwohl said. The current recommendations from the Centers for Disease Control and Prevention call for TB testing before starting patients on all tumor necrosis factor-α blockers.

At follow-up, TB tests are widely performed annually for those on adalimumab, etanercept, and infliximab.

For patients who have had a bacille Calmette-Guérin (BCG) vaccine that could mask the presence of TB, Dr. Lebwohl recommends foregoing the standard purified protein derivative (PPD) TB skin test and instead using the QuantiFERON-TB Gold test. It specifically excludes the antigens that are in BCG.

“BCG does not interfere with this test,” he said.

The QuantiFERON test eliminates the reading bias, does not require a 48-hour follow-up visit, and has no booster effect. The downside is that it does require a blood draw and costs about $90. The test is not more specific or sensitive than the PPD test, he said, but with BCG-treated patients it is certainly more specific.

Obtaining CD4 counts is mandatory for alefacept at baseline and every 2 weeks thereafter.

A complete blood count plus platelet counts are mandatory at baseline for alefacept and efalizumab and are recommended by most physicians for adalimumab, etanercept, and infliximab. At follow-up, the test is generally recommended for all five.

The package insert for efalizumab shows that 8 out of 2,700 patients taking the drug experienced significant thrombocytopenia, which resolved in most patients in 35–112 days. Overall, the onset of platelet decline occurred 2–3 months after the first dose of efalizumab.

In his practice, Dr. Lebwohl checks platelet counts monthly for the first 3 months and every 3 months thereafter. Some evidence suggests the need to check platelets more often—every month for the first 6 months—“but the bottom line is that if you check your bloods for the first 3 months you're not likely to run into trouble with this,” he said.

Chemistry panels plus liver function tests are mandatory at baseline for infliximab and are widely performed but not mandated for alefacept, efalizumab, adalimumab, and etanercept. Annual follow-up is widely performed for most of the biologics and is recommended before infusions of infliximab, but there was not agreement about how often the follow-up should be performed.

Antinuclear antibody (ANA) tests are recommended at baseline by many physicians for adalimumab, etanercept, and infliximab.

The consensus among psoriasis experts, however, is that there is no reason to check ANA at follow-up because patients are supposed to develop ANAs over the course of treatment and it should not be a reason to stop the drug, he said.

“We know that autoimmunity occurs,” Dr. Lebwohl said. “There is no question that we get more ANAs in patients treated with TNF-α blockers.”

Of the few patients who have developed drug-induced lupus, the ANA is the most common change. But a fair number of papers also are emerging on the treatment of lupus with TNF-α blockers (Arthritis Rheum. 2002;46:1408–9).

If there are no other signs of lupus, a positive ANA should not prevent physicians from treating the patient with a TNF-α blocker, Dr. Lebwohl said.

Over the past year, Dr. Lebwohl has been a consultant and speaker for, or had pending consulting agreements with, a number of drug companies, including Abbott, Amgen, Astellas, Centocor, Connetics, Genentech, Novartis, and Warner Chilcott. He also has served as a speaker for Allergan.

Patients should be given the influenza vaccine and the pneumococcal vaccine before treatment begins. DR. LEBWOHL

NEW YORK — Psoriasis patients taking biologic therapies require careful monitoring, including a number of lab tests and vaccinations, Dr. Mark Lebwohl said at a meeting on medical and surgical dermatology sponsored by the Mount Sinai School of Medicine.

Seasonal flu vaccines, for example, are not mandated but are widely received by patients taking all five of the top biologics to treat psoriasis—alefacept (Amevive), efalizumab (Raptiva), adalimumab (Humira), etanercept (Enbrel), and infliximab (Remicade).

Dr. Lebwohl outlined the current consensus on proper monitoring and vaccination based on package inserts, medical literature, a survey of the medical advisory board members of the National Psoriasis Foundation, and the best practices from colleagues in other specialties.

Ideally, psoriasis patients on biologics should be given the influenza vaccine and the pneumococcal vaccine, if indicated by age, before treatment begins. However, studies have shown that there is still a healthy immune response after therapy begins, so they can be given after treatment is initiated as well, said Dr. Lebwohl, professor and chairman of the department of dermatology at Mount Sinai, in New York.

Tuberculosis tests are not mandated but are widely performed at baseline for alefacept and efalizumab and are recommended by most physicians at baseline for etanercept. TB tests are mandatory at baseline when treating patients with adalimumab and infliximab, Dr. Lebwohl said. The current recommendations from the Centers for Disease Control and Prevention call for TB testing before starting patients on all tumor necrosis factor-α blockers.

At follow-up, TB tests are widely performed annually for those on adalimumab, etanercept, and infliximab.

For patients who have had a bacille Calmette-Guérin (BCG) vaccine that could mask the presence of TB, Dr. Lebwohl recommends foregoing the standard purified protein derivative (PPD) TB skin test and instead using the QuantiFERON-TB Gold test. It specifically excludes the antigens that are in BCG.

“BCG does not interfere with this test,” he said.

The QuantiFERON test eliminates the reading bias, does not require a 48-hour follow-up visit, and has no booster effect. The downside is that it does require a blood draw and costs about $90. The test is not more specific or sensitive than the PPD test, he said, but with BCG-treated patients it is certainly more specific.

Obtaining CD4 counts is mandatory for alefacept at baseline and every 2 weeks thereafter.

A complete blood count plus platelet counts are mandatory at baseline for alefacept and efalizumab and are recommended by most physicians for adalimumab, etanercept, and infliximab. At follow-up, the test is generally recommended for all five.

The package insert for efalizumab shows that 8 out of 2,700 patients taking the drug experienced significant thrombocytopenia, which resolved in most patients in 35–112 days. Overall, the onset of platelet decline occurred 2–3 months after the first dose of efalizumab.

In his practice, Dr. Lebwohl checks platelet counts monthly for the first 3 months and every 3 months thereafter. Some evidence suggests the need to check platelets more often—every month for the first 6 months—“but the bottom line is that if you check your bloods for the first 3 months you're not likely to run into trouble with this,” he said.

Chemistry panels plus liver function tests are mandatory at baseline for infliximab and are widely performed but not mandated for alefacept, efalizumab, adalimumab, and etanercept. Annual follow-up is widely performed for most of the biologics and is recommended before infusions of infliximab, but there was not agreement about how often the follow-up should be performed.

Antinuclear antibody (ANA) tests are recommended at baseline by many physicians for adalimumab, etanercept, and infliximab.

The consensus among psoriasis experts, however, is that there is no reason to check ANA at follow-up because patients are supposed to develop ANAs over the course of treatment and it should not be a reason to stop the drug, he said.

“We know that autoimmunity occurs,” Dr. Lebwohl said. “There is no question that we get more ANAs in patients treated with TNF-α blockers.”

Of the few patients who have developed drug-induced lupus, the ANA is the most common change. But a fair number of papers also are emerging on the treatment of lupus with TNF-α blockers (Arthritis Rheum. 2002;46:1408–9).

If there are no other signs of lupus, a positive ANA should not prevent physicians from treating the patient with a TNF-α blocker, Dr. Lebwohl said.

Over the past year, Dr. Lebwohl has been a consultant and speaker for, or had pending consulting agreements with, a number of drug companies, including Abbott, Amgen, Astellas, Centocor, Connetics, Genentech, Novartis, and Warner Chilcott. He also has served as a speaker for Allergan.

Patients should be given the influenza vaccine and the pneumococcal vaccine before treatment begins. DR. LEBWOHL

Off-Label Use of Atypicals

Evidence is limited in many cases to support the off-label use of atypical antipsychotics, according to an analysis from the Agency for Healthcare Research and Quality (AHRQ). However, these drugs may pose an increased risk of adverse events, such as stroke, tremors, and weight gain, the report said. Currently, atypical antipsychotics are approved only for use in treating schizophrenia and bipolar disorder. The AHRQ report examines the evidence for the off-label use of aripiprazole, olanzapine, quetiapine, risperidone, and ziprasidone in treating dementia and severe geriatric agitation, depression, obsessive-compulsive disorder, posttraumatic stress disorder, and personality disorders. Researchers found, for example, that the strength of evidence for using atypical antipsychotics in treating personality disorders was considered very low because of small effects, small study sizes, and limitations in trial quality. “Caution is necessary in the off-label use of atypical antipsychotics, especially when used in the elderly and when the evidence for effectiveness is not good,” Dr. Carolyn M. Clancy, AHRQ director, said in a statement.

More States Pass Parity Laws

New York and Ohio recently became the latest two states to enact mental health parity laws. Forty-two states now have enacted some form of mental health parity law, according to the National Alliance on Mental Illness. At the end of last year, former New York Gov. George E. Pataki (R) signed Timothy's Law, which requires insurance companies to provide coverage for individuals with mental illness that is comparable with the policies for other medical care. The law also sets additional requirements, including coverage of at least 30 days of active inpatient care in a calendar year. In Ohio, insurers who offer basic health care services also must offer diagnostic and treatment services for biologically based mental illnesses. However, insurers do not have to provide this coverage if they can prove that it independently caused their expenses to increase by more than 1% per year. Former Ohio Gov. Bob Taft (R) signed this legislation into law at the end of 2006.

Alcohol, Drug Screening Coverage

Physicians may have an easier time getting paid for screening and treating patients for alcohol and drug abuse thanks to a new Medicaid coverage policy. Starting Jan. 1, officials at the Centers for Medicare and Medicaid Services have added two new codes to the Healthcare Service Procedures Coding System (HCPCS) Level II coding system–one for use for alcohol and drug screening (H0049) and another for brief intervention (H0050). “Fewer than 10% of adults with alcohol and drug disorders are identified and treated,” said Eric Goplerud, Ph.D., project director of the alcohol treatment program at George Washington University, Washington. “The new codes will encourage doctors to address alcohol and drug problems, leading to a reduction in the tremendous social and medical costs associated with addiction.”

Lilly Reaches Zyprexa Settlement

The drugmaker Eli Lilly & Co. has agreed to pay up to $500 million to settle approximately 18,000 claims related to its atypical antipsychotic Zyprexa (olanzapine). Most of the claims stated that, before September 2003, the Zyprexa package insert did not adequately display the risk of hyperglycemia and diabetes. In September 2003, the Food and Drug Administration required a label change for all atypical antipsychotics that added information about a relationship between diabetes and this type of medication. Zyprexa has been approved for the treatment of schizophrenia and bipolar disorder. “While we remain confident that these claims are without merit, we took this difficult step because we believe it is in the best interest of the company, the patients who depend on this medication, and their physicians,” Sidney Taurel, CEO of Eli Lilly, said in a statement. The settlement also means that any claims in which physicians are named as codefendants will be dismissed, according to Eli Lilly. Approximately 1,200 Zyprexa claims were not included in the settlement.

Rules Slow Medicaid Enrollment

New requirements that Medicaid beneficiaries show proof of citizenship is contributing to decreases in enrollment and backlogs in processing applications in several states, according to a new report from the Kaiser Commission on Medicaid and the Uninsured. Beginning on July 1, 2006, individuals applying for Medicaid or seeking to renew their coverage must present proof of citizenship and identity under a provision of the Deficit Reduction Act of 2005. The law exempts certain groups from the requirement, including children in state foster care systems. In Iowa, state Medicaid officials reported that in the months immediately following implementation of the new documentation requirement, the state experienced the largest drop in Medicaid enrollment in the past 5 years. State officials attributed the decline to the documentation requirements and told researchers that they believed the decline was caused by eligible citizens being unable to produce documentation, not undocumented individuals leaving the program. Similar trends were reported in Louisiana, New Hampshire, Virginia, and Wisconsin. “The requirement appears to be obstructing access to health coverage by eligible U.S. citizens, and could place a considerable burden on working families in particular,” the researchers wrote in the report.

Off-Label Use of Atypicals

Evidence is limited in many cases to support the off-label use of atypical antipsychotics, according to an analysis from the Agency for Healthcare Research and Quality (AHRQ). However, these drugs may pose an increased risk of adverse events, such as stroke, tremors, and weight gain, the report said. Currently, atypical antipsychotics are approved only for use in treating schizophrenia and bipolar disorder. The AHRQ report examines the evidence for the off-label use of aripiprazole, olanzapine, quetiapine, risperidone, and ziprasidone in treating dementia and severe geriatric agitation, depression, obsessive-compulsive disorder, posttraumatic stress disorder, and personality disorders. Researchers found, for example, that the strength of evidence for using atypical antipsychotics in treating personality disorders was considered very low because of small effects, small study sizes, and limitations in trial quality. “Caution is necessary in the off-label use of atypical antipsychotics, especially when used in the elderly and when the evidence for effectiveness is not good,” Dr. Carolyn M. Clancy, AHRQ director, said in a statement.

More States Pass Parity Laws

New York and Ohio recently became the latest two states to enact mental health parity laws. Forty-two states now have enacted some form of mental health parity law, according to the National Alliance on Mental Illness. At the end of last year, former New York Gov. George E. Pataki (R) signed Timothy's Law, which requires insurance companies to provide coverage for individuals with mental illness that is comparable with the policies for other medical care. The law also sets additional requirements, including coverage of at least 30 days of active inpatient care in a calendar year. In Ohio, insurers who offer basic health care services also must offer diagnostic and treatment services for biologically based mental illnesses. However, insurers do not have to provide this coverage if they can prove that it independently caused their expenses to increase by more than 1% per year. Former Ohio Gov. Bob Taft (R) signed this legislation into law at the end of 2006.

Alcohol, Drug Screening Coverage

Physicians may have an easier time getting paid for screening and treating patients for alcohol and drug abuse thanks to a new Medicaid coverage policy. Starting Jan. 1, officials at the Centers for Medicare and Medicaid Services have added two new codes to the Healthcare Service Procedures Coding System (HCPCS) Level II coding system–one for use for alcohol and drug screening (H0049) and another for brief intervention (H0050). “Fewer than 10% of adults with alcohol and drug disorders are identified and treated,” said Eric Goplerud, Ph.D., project director of the alcohol treatment program at George Washington University, Washington. “The new codes will encourage doctors to address alcohol and drug problems, leading to a reduction in the tremendous social and medical costs associated with addiction.”

Lilly Reaches Zyprexa Settlement

The drugmaker Eli Lilly & Co. has agreed to pay up to $500 million to settle approximately 18,000 claims related to its atypical antipsychotic Zyprexa (olanzapine). Most of the claims stated that, before September 2003, the Zyprexa package insert did not adequately display the risk of hyperglycemia and diabetes. In September 2003, the Food and Drug Administration required a label change for all atypical antipsychotics that added information about a relationship between diabetes and this type of medication. Zyprexa has been approved for the treatment of schizophrenia and bipolar disorder. “While we remain confident that these claims are without merit, we took this difficult step because we believe it is in the best interest of the company, the patients who depend on this medication, and their physicians,” Sidney Taurel, CEO of Eli Lilly, said in a statement. The settlement also means that any claims in which physicians are named as codefendants will be dismissed, according to Eli Lilly. Approximately 1,200 Zyprexa claims were not included in the settlement.

Rules Slow Medicaid Enrollment

New requirements that Medicaid beneficiaries show proof of citizenship is contributing to decreases in enrollment and backlogs in processing applications in several states, according to a new report from the Kaiser Commission on Medicaid and the Uninsured. Beginning on July 1, 2006, individuals applying for Medicaid or seeking to renew their coverage must present proof of citizenship and identity under a provision of the Deficit Reduction Act of 2005. The law exempts certain groups from the requirement, including children in state foster care systems. In Iowa, state Medicaid officials reported that in the months immediately following implementation of the new documentation requirement, the state experienced the largest drop in Medicaid enrollment in the past 5 years. State officials attributed the decline to the documentation requirements and told researchers that they believed the decline was caused by eligible citizens being unable to produce documentation, not undocumented individuals leaving the program. Similar trends were reported in Louisiana, New Hampshire, Virginia, and Wisconsin. “The requirement appears to be obstructing access to health coverage by eligible U.S. citizens, and could place a considerable burden on working families in particular,” the researchers wrote in the report.

Off-Label Use of Atypicals

Evidence is limited in many cases to support the off-label use of atypical antipsychotics, according to an analysis from the Agency for Healthcare Research and Quality (AHRQ). However, these drugs may pose an increased risk of adverse events, such as stroke, tremors, and weight gain, the report said. Currently, atypical antipsychotics are approved only for use in treating schizophrenia and bipolar disorder. The AHRQ report examines the evidence for the off-label use of aripiprazole, olanzapine, quetiapine, risperidone, and ziprasidone in treating dementia and severe geriatric agitation, depression, obsessive-compulsive disorder, posttraumatic stress disorder, and personality disorders. Researchers found, for example, that the strength of evidence for using atypical antipsychotics in treating personality disorders was considered very low because of small effects, small study sizes, and limitations in trial quality. “Caution is necessary in the off-label use of atypical antipsychotics, especially when used in the elderly and when the evidence for effectiveness is not good,” Dr. Carolyn M. Clancy, AHRQ director, said in a statement.

More States Pass Parity Laws

New York and Ohio recently became the latest two states to enact mental health parity laws. Forty-two states now have enacted some form of mental health parity law, according to the National Alliance on Mental Illness. At the end of last year, former New York Gov. George E. Pataki (R) signed Timothy's Law, which requires insurance companies to provide coverage for individuals with mental illness that is comparable with the policies for other medical care. The law also sets additional requirements, including coverage of at least 30 days of active inpatient care in a calendar year. In Ohio, insurers who offer basic health care services also must offer diagnostic and treatment services for biologically based mental illnesses. However, insurers do not have to provide this coverage if they can prove that it independently caused their expenses to increase by more than 1% per year. Former Ohio Gov. Bob Taft (R) signed this legislation into law at the end of 2006.

Alcohol, Drug Screening Coverage

Physicians may have an easier time getting paid for screening and treating patients for alcohol and drug abuse thanks to a new Medicaid coverage policy. Starting Jan. 1, officials at the Centers for Medicare and Medicaid Services have added two new codes to the Healthcare Service Procedures Coding System (HCPCS) Level II coding system–one for use for alcohol and drug screening (H0049) and another for brief intervention (H0050). “Fewer than 10% of adults with alcohol and drug disorders are identified and treated,” said Eric Goplerud, Ph.D., project director of the alcohol treatment program at George Washington University, Washington. “The new codes will encourage doctors to address alcohol and drug problems, leading to a reduction in the tremendous social and medical costs associated with addiction.”

Lilly Reaches Zyprexa Settlement

The drugmaker Eli Lilly & Co. has agreed to pay up to $500 million to settle approximately 18,000 claims related to its atypical antipsychotic Zyprexa (olanzapine). Most of the claims stated that, before September 2003, the Zyprexa package insert did not adequately display the risk of hyperglycemia and diabetes. In September 2003, the Food and Drug Administration required a label change for all atypical antipsychotics that added information about a relationship between diabetes and this type of medication. Zyprexa has been approved for the treatment of schizophrenia and bipolar disorder. “While we remain confident that these claims are without merit, we took this difficult step because we believe it is in the best interest of the company, the patients who depend on this medication, and their physicians,” Sidney Taurel, CEO of Eli Lilly, said in a statement. The settlement also means that any claims in which physicians are named as codefendants will be dismissed, according to Eli Lilly. Approximately 1,200 Zyprexa claims were not included in the settlement.

Rules Slow Medicaid Enrollment

New requirements that Medicaid beneficiaries show proof of citizenship is contributing to decreases in enrollment and backlogs in processing applications in several states, according to a new report from the Kaiser Commission on Medicaid and the Uninsured. Beginning on July 1, 2006, individuals applying for Medicaid or seeking to renew their coverage must present proof of citizenship and identity under a provision of the Deficit Reduction Act of 2005. The law exempts certain groups from the requirement, including children in state foster care systems. In Iowa, state Medicaid officials reported that in the months immediately following implementation of the new documentation requirement, the state experienced the largest drop in Medicaid enrollment in the past 5 years. State officials attributed the decline to the documentation requirements and told researchers that they believed the decline was caused by eligible citizens being unable to produce documentation, not undocumented individuals leaving the program. Similar trends were reported in Louisiana, New Hampshire, Virginia, and Wisconsin. “The requirement appears to be obstructing access to health coverage by eligible U.S. citizens, and could place a considerable burden on working families in particular,” the researchers wrote in the report.

The clock is ticking for physicians to sign up for a National Provider Identifier, the new 10-digit number that will be used by Medicare, Medicaid, and many private health plans to process claims.

The deadline for registering for an NPI number is May 23.

Physicians who are not using an NPI after that date could experience cash flow disruptions, according to the Centers for Medicare and Medicaid Services.

The transition to a single identifier that can be used across health plans is required under the Health Insurance Portability and Accountability Act (HIPAA) of 1996. Most health plans and all health care clearinghouses must begin using NPIs to process physicians' claims in standard transactions by May 23. Small health plans have another year to become compliant.

“The NPI is the new standard identifying number for all healthcare billing transactions, not just for billing Medicare or Medicaid. National standards like the NPI will make electronic data exchanges a viable and preferable alternative to paper processing for health care providers and health plans alike,” said Aaron Hase, a CMS spokesman. As of Jan. 29, more than 1.6 million NPIs had been assigned, according to CMS.

Physicians and other health care providers can apply for an NPI online or by using a paper application. In addition, organizations like hospitals or professional associations can submit applications for several physicians in an electronic file.

Officials at CMS are urging physicians who haven't yet signed up to do so soon. A physician who submits a properly completed electronic application could have his or her NPI in 10 days. However, it can take 120 days to do the remaining work to use it, Mr. Hase said. The preparation includes working on internal billing systems; coordinating with billing services, vendors, and clearinghouses; and testing the new identifier with payers, he said.

So far, the process of obtaining an NPI has been relatively easy, said Brian Whitman, senior analyst for regulatory and insurer affairs at the American College of Physicians. The application process itself takes only about 10 minutes, he said.

But one thing to be aware of is that you may already have an NPI. Because some large employers may have already registered their providers, physicians may be surprised to learn that they already have a number, Mr. Whitman said.

As the May deadline approaches and more and more physicians get registered, the next question is how widely CMS plans to disseminate the NPIs. CMS officials have said they are considering creating some type of directory of NPIs that could be available to physicians and office staff.

Physicians can apply for an NPI online at https://nppes.cms.hhs.gov

The clock is ticking for physicians to sign up for a National Provider Identifier, the new 10-digit number that will be used by Medicare, Medicaid, and many private health plans to process claims.

The deadline for registering for an NPI number is May 23.

Physicians who are not using an NPI after that date could experience cash flow disruptions, according to the Centers for Medicare and Medicaid Services.

The transition to a single identifier that can be used across health plans is required under the Health Insurance Portability and Accountability Act (HIPAA) of 1996. Most health plans and all health care clearinghouses must begin using NPIs to process physicians' claims in standard transactions by May 23. Small health plans have another year to become compliant.

“The NPI is the new standard identifying number for all healthcare billing transactions, not just for billing Medicare or Medicaid. National standards like the NPI will make electronic data exchanges a viable and preferable alternative to paper processing for health care providers and health plans alike,” said Aaron Hase, a CMS spokesman. As of Jan. 29, more than 1.6 million NPIs had been assigned, according to CMS.

Physicians and other health care providers can apply for an NPI online or by using a paper application. In addition, organizations like hospitals or professional associations can submit applications for several physicians in an electronic file.

Officials at CMS are urging physicians who haven't yet signed up to do so soon. A physician who submits a properly completed electronic application could have his or her NPI in 10 days. However, it can take 120 days to do the remaining work to use it, Mr. Hase said. The preparation includes working on internal billing systems; coordinating with billing services, vendors, and clearinghouses; and testing the new identifier with payers, he said.

So far, the process of obtaining an NPI has been relatively easy, said Brian Whitman, senior analyst for regulatory and insurer affairs at the American College of Physicians. The application process itself takes only about 10 minutes, he said.

But one thing to be aware of is that you may already have an NPI. Because some large employers may have already registered their providers, physicians may be surprised to learn that they already have a number, Mr. Whitman said.

As the May deadline approaches and more and more physicians get registered, the next question is how widely CMS plans to disseminate the NPIs. CMS officials have said they are considering creating some type of directory of NPIs that could be available to physicians and office staff.

Physicians can apply for an NPI online at https://nppes.cms.hhs.gov

The clock is ticking for physicians to sign up for a National Provider Identifier, the new 10-digit number that will be used by Medicare, Medicaid, and many private health plans to process claims.

The deadline for registering for an NPI number is May 23.

Physicians who are not using an NPI after that date could experience cash flow disruptions, according to the Centers for Medicare and Medicaid Services.

The transition to a single identifier that can be used across health plans is required under the Health Insurance Portability and Accountability Act (HIPAA) of 1996. Most health plans and all health care clearinghouses must begin using NPIs to process physicians' claims in standard transactions by May 23. Small health plans have another year to become compliant.

“The NPI is the new standard identifying number for all healthcare billing transactions, not just for billing Medicare or Medicaid. National standards like the NPI will make electronic data exchanges a viable and preferable alternative to paper processing for health care providers and health plans alike,” said Aaron Hase, a CMS spokesman. As of Jan. 29, more than 1.6 million NPIs had been assigned, according to CMS.

Physicians and other health care providers can apply for an NPI online or by using a paper application. In addition, organizations like hospitals or professional associations can submit applications for several physicians in an electronic file.

Officials at CMS are urging physicians who haven't yet signed up to do so soon. A physician who submits a properly completed electronic application could have his or her NPI in 10 days. However, it can take 120 days to do the remaining work to use it, Mr. Hase said. The preparation includes working on internal billing systems; coordinating with billing services, vendors, and clearinghouses; and testing the new identifier with payers, he said.

So far, the process of obtaining an NPI has been relatively easy, said Brian Whitman, senior analyst for regulatory and insurer affairs at the American College of Physicians. The application process itself takes only about 10 minutes, he said.

But one thing to be aware of is that you may already have an NPI. Because some large employers may have already registered their providers, physicians may be surprised to learn that they already have a number, Mr. Whitman said.

As the May deadline approaches and more and more physicians get registered, the next question is how widely CMS plans to disseminate the NPIs. CMS officials have said they are considering creating some type of directory of NPIs that could be available to physicians and office staff.

Physicians can apply for an NPI online at https://nppes.cms.hhs.gov