Mary Ellen Schneider

More than two-thirds of African American patients who have suffered a myocardial infarction say the event was a “wake-up call,” but a quarter of patients also report that they did not see their physician regularly after the attack, according to a survey released by the National Medical Association.

“Obviously, there's a disconnect here,” said Dr. Clyde W. Yancy, medical director of the Heart and Vascular Institute at Baylor University Medical Center in Dallas.

Physicians and researchers need to better understand this contradiction because it's an opportunity to improve outcomes among African American patients, Dr. Yancy said during a teleconference sponsored by the National Medical Association (NMA) and supported by GlaxoSmithKline.

The survey, which was commissioned by the NMA and supported by GlaxoSmithKline, was conducted online among 502 African American adults aged 18 years and older who had experienced a myocardial infarction.

African Americans have a significantly higher risk for virtually every cardiovascular disease than their Caucasian counterparts do, Dr. Yancy said. And when it comes to myocardial infarction, African American men have the highest incidence of first heart attacks, followed by Caucasian men, and closely followed by African American women.

But despite the increased risk, there is a lack of awareness. “The perception is that the African American community is not at risk, particularly for heart attacks,” Dr. Yancy said. “Awareness needs to be elevated in a major way.”

The NMA survey showed that most respondents saw their myocardial infarction as a significant event, with 64% saying they felt that they had been given a second chance at life, and 46% saying that they were significantly worried about having another heart attack.

However, the survey also found that they were not taking steps to avoid another cardiac event. For example, 22% of respondents reported not taking medication exactly as prescribed and 21% said that they do not monitor their eating habits.

The survey results also revealed that African American patients are in need of increased support in the period following a myocardial infarction. Less than half of respondents (47%) said they had family and friends who remind them to take their medications, and 27% said they did not feel knowledgeable about how to manage their health after an attack.

Part of the problem may come down to socioeconomic factors, Dr. Yancy said. Patients may be neglecting their medications and physician visits because they lack the resources and support.

Other factors include a possible lack of trust of physicians by African American patients, a belief that they have not received the best medicine, and a lack of education about potential side effects. “I've learned that up-front awareness makes a huge difference,” Dr. Yancy said.

More than two-thirds of African American patients who have suffered a myocardial infarction say the event was a “wake-up call,” but a quarter of patients also report that they did not see their physician regularly after the attack, according to a survey released by the National Medical Association.

“Obviously, there's a disconnect here,” said Dr. Clyde W. Yancy, medical director of the Heart and Vascular Institute at Baylor University Medical Center in Dallas.

Physicians and researchers need to better understand this contradiction because it's an opportunity to improve outcomes among African American patients, Dr. Yancy said during a teleconference sponsored by the National Medical Association (NMA) and supported by GlaxoSmithKline.

The survey, which was commissioned by the NMA and supported by GlaxoSmithKline, was conducted online among 502 African American adults aged 18 years and older who had experienced a myocardial infarction.

African Americans have a significantly higher risk for virtually every cardiovascular disease than their Caucasian counterparts do, Dr. Yancy said. And when it comes to myocardial infarction, African American men have the highest incidence of first heart attacks, followed by Caucasian men, and closely followed by African American women.

But despite the increased risk, there is a lack of awareness. “The perception is that the African American community is not at risk, particularly for heart attacks,” Dr. Yancy said. “Awareness needs to be elevated in a major way.”

The NMA survey showed that most respondents saw their myocardial infarction as a significant event, with 64% saying they felt that they had been given a second chance at life, and 46% saying that they were significantly worried about having another heart attack.

However, the survey also found that they were not taking steps to avoid another cardiac event. For example, 22% of respondents reported not taking medication exactly as prescribed and 21% said that they do not monitor their eating habits.

The survey results also revealed that African American patients are in need of increased support in the period following a myocardial infarction. Less than half of respondents (47%) said they had family and friends who remind them to take their medications, and 27% said they did not feel knowledgeable about how to manage their health after an attack.

Part of the problem may come down to socioeconomic factors, Dr. Yancy said. Patients may be neglecting their medications and physician visits because they lack the resources and support.

Other factors include a possible lack of trust of physicians by African American patients, a belief that they have not received the best medicine, and a lack of education about potential side effects. “I've learned that up-front awareness makes a huge difference,” Dr. Yancy said.

More than two-thirds of African American patients who have suffered a myocardial infarction say the event was a “wake-up call,” but a quarter of patients also report that they did not see their physician regularly after the attack, according to a survey released by the National Medical Association.

“Obviously, there's a disconnect here,” said Dr. Clyde W. Yancy, medical director of the Heart and Vascular Institute at Baylor University Medical Center in Dallas.

Physicians and researchers need to better understand this contradiction because it's an opportunity to improve outcomes among African American patients, Dr. Yancy said during a teleconference sponsored by the National Medical Association (NMA) and supported by GlaxoSmithKline.

The survey, which was commissioned by the NMA and supported by GlaxoSmithKline, was conducted online among 502 African American adults aged 18 years and older who had experienced a myocardial infarction.

African Americans have a significantly higher risk for virtually every cardiovascular disease than their Caucasian counterparts do, Dr. Yancy said. And when it comes to myocardial infarction, African American men have the highest incidence of first heart attacks, followed by Caucasian men, and closely followed by African American women.

But despite the increased risk, there is a lack of awareness. “The perception is that the African American community is not at risk, particularly for heart attacks,” Dr. Yancy said. “Awareness needs to be elevated in a major way.”

The NMA survey showed that most respondents saw their myocardial infarction as a significant event, with 64% saying they felt that they had been given a second chance at life, and 46% saying that they were significantly worried about having another heart attack.

However, the survey also found that they were not taking steps to avoid another cardiac event. For example, 22% of respondents reported not taking medication exactly as prescribed and 21% said that they do not monitor their eating habits.

The survey results also revealed that African American patients are in need of increased support in the period following a myocardial infarction. Less than half of respondents (47%) said they had family and friends who remind them to take their medications, and 27% said they did not feel knowledgeable about how to manage their health after an attack.

Part of the problem may come down to socioeconomic factors, Dr. Yancy said. Patients may be neglecting their medications and physician visits because they lack the resources and support.

Other factors include a possible lack of trust of physicians by African American patients, a belief that they have not received the best medicine, and a lack of education about potential side effects. “I've learned that up-front awareness makes a huge difference,” Dr. Yancy said.

Physicians who report quality data to Medicare will receive bonus payments of 1.5% starting in July under a provision of the omnibus legislation passed at the end of the 109th Congress.

Under the provision, bonus payments would be linked to participation in the Physician Voluntary Reporting Program administered by the Centers for Medicare and Medicaid Services. The program, which allows physicians to submit quality data to CMS and receive feedback on their performance, was launched in 2006.

In 2007, CMS officials have expanded the number of quality measures included in the program from 16 to 45. CMS also released an additional set of 21 measures that it plans to introduce later in the year. Bonus payments will apply to services delivered from July 1 through Dec. 31, 2007. Under the legislation, CMS must post any changes to the quality measures by no later than April 1.

More details on the program will be forthcoming from CMS, according to an agency spokesperson. For now, Congress has set up some parameters for reporting to the voluntary program. For example, if three or fewer measures are applicable to a physician's practice, participating physicians must report on each relevant quality measure. If four or more are applicable, participating physicians must report on at least three.

CMS is required to publish a set of proposed quality measures for 2008 no later than Aug. 15 with a final set of measures to be published by Nov. 15. Congress also has instructed the secretary of Health and Human Services to address a mechanism for physicians to submit data through a medical registry system, such as the Society of Thoracic Surgeons National Database, in 2008.

Officials at the American Medical Association plan to work with CMS on the implementation of the quality reporting program.

The AMA noted that it will work to ensure that the quality measures developed by its Physician Consortium for Performance Improvement continue to be the foundation of Medicare's reporting program. “We will work closely with the incoming Congress to address concerns with the current reporting framework,” Dr. Cecil Wilson, AMA board chair, said in a statement.

Officials at the American College of Physicians voiced concerns about the program. Dr. Michael S. Barr, vice president of practice, advocacy, and improvement at the ACP, said that not all of the 45 measures being rolled out have been endorsed by either the National Quality Forum or the AQA alliance, originally known as the Ambulatory Care Quality Alliance.

“We're concerned about going too fast,” he said.

For more information, visit www.cms.hhs.gov/PVRP

Physicians who report quality data to Medicare will receive bonus payments of 1.5% starting in July under a provision of the omnibus legislation passed at the end of the 109th Congress.

Under the provision, bonus payments would be linked to participation in the Physician Voluntary Reporting Program administered by the Centers for Medicare and Medicaid Services. The program, which allows physicians to submit quality data to CMS and receive feedback on their performance, was launched in 2006.

In 2007, CMS officials have expanded the number of quality measures included in the program from 16 to 45. CMS also released an additional set of 21 measures that it plans to introduce later in the year. Bonus payments will apply to services delivered from July 1 through Dec. 31, 2007. Under the legislation, CMS must post any changes to the quality measures by no later than April 1.

More details on the program will be forthcoming from CMS, according to an agency spokesperson. For now, Congress has set up some parameters for reporting to the voluntary program. For example, if three or fewer measures are applicable to a physician's practice, participating physicians must report on each relevant quality measure. If four or more are applicable, participating physicians must report on at least three.

CMS is required to publish a set of proposed quality measures for 2008 no later than Aug. 15 with a final set of measures to be published by Nov. 15. Congress also has instructed the secretary of Health and Human Services to address a mechanism for physicians to submit data through a medical registry system, such as the Society of Thoracic Surgeons National Database, in 2008.

Officials at the American Medical Association plan to work with CMS on the implementation of the quality reporting program.

The AMA noted that it will work to ensure that the quality measures developed by its Physician Consortium for Performance Improvement continue to be the foundation of Medicare's reporting program. “We will work closely with the incoming Congress to address concerns with the current reporting framework,” Dr. Cecil Wilson, AMA board chair, said in a statement.

Officials at the American College of Physicians voiced concerns about the program. Dr. Michael S. Barr, vice president of practice, advocacy, and improvement at the ACP, said that not all of the 45 measures being rolled out have been endorsed by either the National Quality Forum or the AQA alliance, originally known as the Ambulatory Care Quality Alliance.

“We're concerned about going too fast,” he said.

For more information, visit www.cms.hhs.gov/PVRP

Physicians who report quality data to Medicare will receive bonus payments of 1.5% starting in July under a provision of the omnibus legislation passed at the end of the 109th Congress.

Under the provision, bonus payments would be linked to participation in the Physician Voluntary Reporting Program administered by the Centers for Medicare and Medicaid Services. The program, which allows physicians to submit quality data to CMS and receive feedback on their performance, was launched in 2006.

In 2007, CMS officials have expanded the number of quality measures included in the program from 16 to 45. CMS also released an additional set of 21 measures that it plans to introduce later in the year. Bonus payments will apply to services delivered from July 1 through Dec. 31, 2007. Under the legislation, CMS must post any changes to the quality measures by no later than April 1.

More details on the program will be forthcoming from CMS, according to an agency spokesperson. For now, Congress has set up some parameters for reporting to the voluntary program. For example, if three or fewer measures are applicable to a physician's practice, participating physicians must report on each relevant quality measure. If four or more are applicable, participating physicians must report on at least three.

CMS is required to publish a set of proposed quality measures for 2008 no later than Aug. 15 with a final set of measures to be published by Nov. 15. Congress also has instructed the secretary of Health and Human Services to address a mechanism for physicians to submit data through a medical registry system, such as the Society of Thoracic Surgeons National Database, in 2008.

Officials at the American Medical Association plan to work with CMS on the implementation of the quality reporting program.

The AMA noted that it will work to ensure that the quality measures developed by its Physician Consortium for Performance Improvement continue to be the foundation of Medicare's reporting program. “We will work closely with the incoming Congress to address concerns with the current reporting framework,” Dr. Cecil Wilson, AMA board chair, said in a statement.

Officials at the American College of Physicians voiced concerns about the program. Dr. Michael S. Barr, vice president of practice, advocacy, and improvement at the ACP, said that not all of the 45 measures being rolled out have been endorsed by either the National Quality Forum or the AQA alliance, originally known as the Ambulatory Care Quality Alliance.

“We're concerned about going too fast,” he said.

For more information, visit www.cms.hhs.gov/PVRP

RENO, NEV. — Increased body mass index is correlated with worsening proteinuria in children, Dr. Carolyn Abitbol said at the annual meeting of the American College of Nutrition.

The findings, which are the result of a retrospective observational case-matched study of 60 children with proteinuria, confirm the hypothesis that obesity contributes to a decline in the glomerular filtration rate, an indicator of kidney function, said Dr. Abitbol of the Division of Pediatric Nephrology at the University of Miami.

Low-birth-weight infants may be more likely to develop obesity in childhood because of disproportionate height deficits in this population, making low birth weight an independent risk factor for the progression of chronic kidney disease in children, she said. These children also are born with fewer nephrons, the functioning units of the mature kidney.

The study included 40 obese children: 16 low-birth-weight children (less than 1,200 g) and 24 children of normal birth weight (over 2,500 g). Obesity was defined as a body mass index of greater than the 95th percentile for age and gender.

The study also included 20 nonobese children of normal birth weight as clinical controls. All children in the study had proteinuric kidney disease. The researchers excluded any patients who had acute glomerulonephritis, immune-mediated nephritis, or overt diabetes, as well as patients who had HIV nephropathy.

Dr. Abitbol and her colleagues performed kidney biopsies of nine children in the obese, low-birth-weight group and all had focal segmental glomerulosclerosis (FSGS).

Among children in the normal-birth-weight, obese group, 16 children were biopsied and 14 had FSGS. Additionally, one patient had focal mesangial proliferative glomerulonephropathy, which probably is an early form of FSGS, Dr. Abitbol said. One patient had a membranous nephropathy, which is unique and immune mediated; the diagnosis was made after the exclusion criteria had been applied, she said.

In the control group, all children were biopsied and 14 had FSGS, 4 had mesangial glomerulonephropathy, 1 had minimal change, and 1 was membranous.

The researchers also compared mean renal survival relative to birth weight and found that low-birth-weight patients had a loss of glomerular filtration rate significantly earlier than did those of normal birth weight, despite having a diagnosis at relatively the same age.

ELSEVIER GLOBAL MEDICAL NEWS

RENO, NEV. — Increased body mass index is correlated with worsening proteinuria in children, Dr. Carolyn Abitbol said at the annual meeting of the American College of Nutrition.

The findings, which are the result of a retrospective observational case-matched study of 60 children with proteinuria, confirm the hypothesis that obesity contributes to a decline in the glomerular filtration rate, an indicator of kidney function, said Dr. Abitbol of the Division of Pediatric Nephrology at the University of Miami.

Low-birth-weight infants may be more likely to develop obesity in childhood because of disproportionate height deficits in this population, making low birth weight an independent risk factor for the progression of chronic kidney disease in children, she said. These children also are born with fewer nephrons, the functioning units of the mature kidney.

The study included 40 obese children: 16 low-birth-weight children (less than 1,200 g) and 24 children of normal birth weight (over 2,500 g). Obesity was defined as a body mass index of greater than the 95th percentile for age and gender.

The study also included 20 nonobese children of normal birth weight as clinical controls. All children in the study had proteinuric kidney disease. The researchers excluded any patients who had acute glomerulonephritis, immune-mediated nephritis, or overt diabetes, as well as patients who had HIV nephropathy.

Dr. Abitbol and her colleagues performed kidney biopsies of nine children in the obese, low-birth-weight group and all had focal segmental glomerulosclerosis (FSGS).

Among children in the normal-birth-weight, obese group, 16 children were biopsied and 14 had FSGS. Additionally, one patient had focal mesangial proliferative glomerulonephropathy, which probably is an early form of FSGS, Dr. Abitbol said. One patient had a membranous nephropathy, which is unique and immune mediated; the diagnosis was made after the exclusion criteria had been applied, she said.

In the control group, all children were biopsied and 14 had FSGS, 4 had mesangial glomerulonephropathy, 1 had minimal change, and 1 was membranous.

The researchers also compared mean renal survival relative to birth weight and found that low-birth-weight patients had a loss of glomerular filtration rate significantly earlier than did those of normal birth weight, despite having a diagnosis at relatively the same age.

ELSEVIER GLOBAL MEDICAL NEWS

RENO, NEV. — Increased body mass index is correlated with worsening proteinuria in children, Dr. Carolyn Abitbol said at the annual meeting of the American College of Nutrition.

The findings, which are the result of a retrospective observational case-matched study of 60 children with proteinuria, confirm the hypothesis that obesity contributes to a decline in the glomerular filtration rate, an indicator of kidney function, said Dr. Abitbol of the Division of Pediatric Nephrology at the University of Miami.

Low-birth-weight infants may be more likely to develop obesity in childhood because of disproportionate height deficits in this population, making low birth weight an independent risk factor for the progression of chronic kidney disease in children, she said. These children also are born with fewer nephrons, the functioning units of the mature kidney.

The study included 40 obese children: 16 low-birth-weight children (less than 1,200 g) and 24 children of normal birth weight (over 2,500 g). Obesity was defined as a body mass index of greater than the 95th percentile for age and gender.

The study also included 20 nonobese children of normal birth weight as clinical controls. All children in the study had proteinuric kidney disease. The researchers excluded any patients who had acute glomerulonephritis, immune-mediated nephritis, or overt diabetes, as well as patients who had HIV nephropathy.

Dr. Abitbol and her colleagues performed kidney biopsies of nine children in the obese, low-birth-weight group and all had focal segmental glomerulosclerosis (FSGS).

Among children in the normal-birth-weight, obese group, 16 children were biopsied and 14 had FSGS. Additionally, one patient had focal mesangial proliferative glomerulonephropathy, which probably is an early form of FSGS, Dr. Abitbol said. One patient had a membranous nephropathy, which is unique and immune mediated; the diagnosis was made after the exclusion criteria had been applied, she said.

In the control group, all children were biopsied and 14 had FSGS, 4 had mesangial glomerulonephropathy, 1 had minimal change, and 1 was membranous.

The researchers also compared mean renal survival relative to birth weight and found that low-birth-weight patients had a loss of glomerular filtration rate significantly earlier than did those of normal birth weight, despite having a diagnosis at relatively the same age.

ELSEVIER GLOBAL MEDICAL NEWS

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 provision 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 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.

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 provision 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 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.

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 provision 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 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.

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.

New Osteoporosis Health Claims

Officials at the Food and Drug Administration are proposing to allow a new health claim stating that foods and dietary supplements containing both calcium and vitamin D have the potential to reduce the risk of osteoporosis. The FDA currently allows manufacturers to make only health claims linking calcium intake to a reduced risk of osteoporosis. The new proposal would also broaden the health claim that can be made for products containing calcium by dropping references to sex, race, and age. The change is being proposed based on an FDA review of the scientific evidence, including the 2004 Surgeon General's report on bone health and osteoporosis.

Part D Battle Begins in Congress

As promised during the midterm elections, House Democrats began work immediately on tweaking Medicare's Part D drug coverage. Rep. John Dingell (D-Mich.), along with 189 colleagues, introduced H.R. 4, the Medicare Prescription Drug Price Negotiation Act of 2007, which would require the Health and Human Services department to negotiate prices with drugmakers. The legislation was passed by the House in January by a vote of 255–170. While two senators have taken up the cause—Harry Reid (D-Nev.) and Benjamin Cardin (D-Md.)—it appears the Senate will take a more measured approach. The Senate Finance Committee held hearings Jan. 11 to investigate the impact of price negotiations. If the legislation is enacted as written, new prices would go into effect for the plan year beginning Jan. 1, 2008.

Stem Cell Research Debate Continues

Members of the House of Representatives approved legislation last month that would expand federal funding for human embryonic stem cell research. The bill, H.R. 3, must still be passed in the Senate and faces a potential veto by President Bush, who previously has vetoed the same legislation. In the meantime, states are moving forward with their own stem cell projects. New Jersey Gov. Jon S. Corzine (D) recently signed a law that authorizes the use of $270 million to build stem cell research centers and other facilities for cancer and biomedical research. The bulk of the funding ($150 million) is designated for construction of the Stem Cell Institute in New Brunswick; another $50 million will go to building other stem cell research facilities. The legislation also includes $10 million for cord blood collection to be used in support of stem cell research.

Cancer Care Time Costs Add Up

The cost of the time spent by cancer patients in fighting their illness amounted to approximately $2.3 billion in 2005, according to a study published in the January issue of the Journal of the National Cancer Institute. The researchers analyzed the time that cancer patients spent getting to and from appointments, waiting for care, consulting with physicians, and undergoing treatments. They valued that time at $15.23 per hour, the median U.S. wage rate in 2002. The researchers used data from the Surveillance, Epidemiology, and End Results-Medicare database to find the net patient time costs associated with cancer care for 11 common tumor sites. They analyzed records for 767,010 patients who were initially diagnosed between 1973 and 1999 and were 65 years or older during the study observation period of 1995–2001, and included 1,145,159 matched controls. The net patient time costs associated with medical care during the first 12 months after diagnosis were lowest for melanoma ($271) and prostate cancers ($842) and highest for gastric ($5,348) and ovarian ($5,605) cancers. In most cases, hospital stays accounted for the greatest net time costs.

Weight Loss Supplement Settlement

The Federal Trade Commission recently reached a settlement with manufacturers of four dietary supplement products to limit future advertising claims of weight loss and weight control. Manufacturers of the four products—Xenadrine EFX, CortiSlim, TrimSpa, and One-A-Day WeightSmart—also agreed to pay a total of at least $25 million in cash and other assets. The manufacturers did not admit any violation of the law as part of the settlement. The FTC had alleged that the manufactures of Xenadrine EFX had made false or misleading claims that the product could cause rapid and substantial weight loss. The marketers of CortiSlim faced charges from the FTC that they had falsely claimed that the product would cause weight loss and reduce the risk of serious health conditions. The TrimSpa marketers were alleged to have had inadequate scientific evidence to show that the product causes rapid and substantial weight loss and that one of its ingredients, Hoodia gordonii, works as an appetite suppressant. The marketer of the One-A-Day WeightSmart multivitamin settled FTC allegations that it made unsubstantiated claims of increasing and enhancing metabolism, preventing some weight gain, and controlling weight.

New Osteoporosis Health Claims

Officials at the Food and Drug Administration are proposing to allow a new health claim stating that foods and dietary supplements containing both calcium and vitamin D have the potential to reduce the risk of osteoporosis. The FDA currently allows manufacturers to make only health claims linking calcium intake to a reduced risk of osteoporosis. The new proposal would also broaden the health claim that can be made for products containing calcium by dropping references to sex, race, and age. The change is being proposed based on an FDA review of the scientific evidence, including the 2004 Surgeon General's report on bone health and osteoporosis.

Part D Battle Begins in Congress

As promised during the midterm elections, House Democrats began work immediately on tweaking Medicare's Part D drug coverage. Rep. John Dingell (D-Mich.), along with 189 colleagues, introduced H.R. 4, the Medicare Prescription Drug Price Negotiation Act of 2007, which would require the Health and Human Services department to negotiate prices with drugmakers. The legislation was passed by the House in January by a vote of 255–170. While two senators have taken up the cause—Harry Reid (D-Nev.) and Benjamin Cardin (D-Md.)—it appears the Senate will take a more measured approach. The Senate Finance Committee held hearings Jan. 11 to investigate the impact of price negotiations. If the legislation is enacted as written, new prices would go into effect for the plan year beginning Jan. 1, 2008.

Stem Cell Research Debate Continues

Members of the House of Representatives approved legislation last month that would expand federal funding for human embryonic stem cell research. The bill, H.R. 3, must still be passed in the Senate and faces a potential veto by President Bush, who previously has vetoed the same legislation. In the meantime, states are moving forward with their own stem cell projects. New Jersey Gov. Jon S. Corzine (D) recently signed a law that authorizes the use of $270 million to build stem cell research centers and other facilities for cancer and biomedical research. The bulk of the funding ($150 million) is designated for construction of the Stem Cell Institute in New Brunswick; another $50 million will go to building other stem cell research facilities. The legislation also includes $10 million for cord blood collection to be used in support of stem cell research.

Cancer Care Time Costs Add Up

The cost of the time spent by cancer patients in fighting their illness amounted to approximately $2.3 billion in 2005, according to a study published in the January issue of the Journal of the National Cancer Institute. The researchers analyzed the time that cancer patients spent getting to and from appointments, waiting for care, consulting with physicians, and undergoing treatments. They valued that time at $15.23 per hour, the median U.S. wage rate in 2002. The researchers used data from the Surveillance, Epidemiology, and End Results-Medicare database to find the net patient time costs associated with cancer care for 11 common tumor sites. They analyzed records for 767,010 patients who were initially diagnosed between 1973 and 1999 and were 65 years or older during the study observation period of 1995–2001, and included 1,145,159 matched controls. The net patient time costs associated with medical care during the first 12 months after diagnosis were lowest for melanoma ($271) and prostate cancers ($842) and highest for gastric ($5,348) and ovarian ($5,605) cancers. In most cases, hospital stays accounted for the greatest net time costs.

Weight Loss Supplement Settlement

The Federal Trade Commission recently reached a settlement with manufacturers of four dietary supplement products to limit future advertising claims of weight loss and weight control. Manufacturers of the four products—Xenadrine EFX, CortiSlim, TrimSpa, and One-A-Day WeightSmart—also agreed to pay a total of at least $25 million in cash and other assets. The manufacturers did not admit any violation of the law as part of the settlement. The FTC had alleged that the manufactures of Xenadrine EFX had made false or misleading claims that the product could cause rapid and substantial weight loss. The marketers of CortiSlim faced charges from the FTC that they had falsely claimed that the product would cause weight loss and reduce the risk of serious health conditions. The TrimSpa marketers were alleged to have had inadequate scientific evidence to show that the product causes rapid and substantial weight loss and that one of its ingredients, Hoodia gordonii, works as an appetite suppressant. The marketer of the One-A-Day WeightSmart multivitamin settled FTC allegations that it made unsubstantiated claims of increasing and enhancing metabolism, preventing some weight gain, and controlling weight.

New Osteoporosis Health Claims

Officials at the Food and Drug Administration are proposing to allow a new health claim stating that foods and dietary supplements containing both calcium and vitamin D have the potential to reduce the risk of osteoporosis. The FDA currently allows manufacturers to make only health claims linking calcium intake to a reduced risk of osteoporosis. The new proposal would also broaden the health claim that can be made for products containing calcium by dropping references to sex, race, and age. The change is being proposed based on an FDA review of the scientific evidence, including the 2004 Surgeon General's report on bone health and osteoporosis.

Part D Battle Begins in Congress

As promised during the midterm elections, House Democrats began work immediately on tweaking Medicare's Part D drug coverage. Rep. John Dingell (D-Mich.), along with 189 colleagues, introduced H.R. 4, the Medicare Prescription Drug Price Negotiation Act of 2007, which would require the Health and Human Services department to negotiate prices with drugmakers. The legislation was passed by the House in January by a vote of 255–170. While two senators have taken up the cause—Harry Reid (D-Nev.) and Benjamin Cardin (D-Md.)—it appears the Senate will take a more measured approach. The Senate Finance Committee held hearings Jan. 11 to investigate the impact of price negotiations. If the legislation is enacted as written, new prices would go into effect for the plan year beginning Jan. 1, 2008.

Stem Cell Research Debate Continues

Members of the House of Representatives approved legislation last month that would expand federal funding for human embryonic stem cell research. The bill, H.R. 3, must still be passed in the Senate and faces a potential veto by President Bush, who previously has vetoed the same legislation. In the meantime, states are moving forward with their own stem cell projects. New Jersey Gov. Jon S. Corzine (D) recently signed a law that authorizes the use of $270 million to build stem cell research centers and other facilities for cancer and biomedical research. The bulk of the funding ($150 million) is designated for construction of the Stem Cell Institute in New Brunswick; another $50 million will go to building other stem cell research facilities. The legislation also includes $10 million for cord blood collection to be used in support of stem cell research.

Cancer Care Time Costs Add Up

The cost of the time spent by cancer patients in fighting their illness amounted to approximately $2.3 billion in 2005, according to a study published in the January issue of the Journal of the National Cancer Institute. The researchers analyzed the time that cancer patients spent getting to and from appointments, waiting for care, consulting with physicians, and undergoing treatments. They valued that time at $15.23 per hour, the median U.S. wage rate in 2002. The researchers used data from the Surveillance, Epidemiology, and End Results-Medicare database to find the net patient time costs associated with cancer care for 11 common tumor sites. They analyzed records for 767,010 patients who were initially diagnosed between 1973 and 1999 and were 65 years or older during the study observation period of 1995–2001, and included 1,145,159 matched controls. The net patient time costs associated with medical care during the first 12 months after diagnosis were lowest for melanoma ($271) and prostate cancers ($842) and highest for gastric ($5,348) and ovarian ($5,605) cancers. In most cases, hospital stays accounted for the greatest net time costs.

Weight Loss Supplement Settlement

The Federal Trade Commission recently reached a settlement with manufacturers of four dietary supplement products to limit future advertising claims of weight loss and weight control. Manufacturers of the four products—Xenadrine EFX, CortiSlim, TrimSpa, and One-A-Day WeightSmart—also agreed to pay a total of at least $25 million in cash and other assets. The manufacturers did not admit any violation of the law as part of the settlement. The FTC had alleged that the manufactures of Xenadrine EFX had made false or misleading claims that the product could cause rapid and substantial weight loss. The marketers of CortiSlim faced charges from the FTC that they had falsely claimed that the product would cause weight loss and reduce the risk of serious health conditions. The TrimSpa marketers were alleged to have had inadequate scientific evidence to show that the product causes rapid and substantial weight loss and that one of its ingredients, Hoodia gordonii, works as an appetite suppressant. The marketer of the One-A-Day WeightSmart multivitamin settled FTC allegations that it made unsubstantiated claims of increasing and enhancing metabolism, preventing some weight gain, and controlling weight.

Addressing Neurologic Emergencies

The University of Michigan and the National Institutes of Health recently launched the Neurological Emergencies Treatment Trials (NETT) Network, which will be funded by a $7.7 million grant from the NIH's National Institute of Neurological Disorders and Stroke. The University of Michigan, Ann Arbor, will serve as the coordinating center for the network, and is joined by 11 other research hubs at major medical centers. “Our mission is to improve outcomes of patients with acute neurological problems through innovative research focused on patient care that starts in the ambulance and in the emergency department,” Dr. William G. Barsan, chair of the department of emergency medicine at the university, said in a statement. “NETT will give us the framework to test medications, patient management strategies, and other treatments on a large scale and over a short timeframe.” The first NETT trial is scheduled to begin later this year, pending a waiver of informed consent from the Food and Drug Administration, and will focus on patients who experience status epilepticus.

NINDS Gains New Leadership

Neurologist and researcher Dr. Walter J. Koroshetz has been named deputy director of the National Institute of Neurological Disorders and Stroke. Dr. Koroshetz, formerly vice chair of the neurology service and director of stroke and neurointensive care services at Massachusetts General Hospital in Boston, will work on program planning and budgeting in his new post. Dr. Koroshetz has received NINDS extramural funding for his research on Huntington's disease, neuroprotection, and translational research in acute stroke. “Dr. Koroshetz is an internationally renowned neurologist and outstanding investigator and administrator,” NINDS Director Story Landis, Ph.D., said in a statement. “His leadership skills and recognized expertise in stroke, imaging, training, and neurointensive care will serve the Institute well.”

Stroke Legislation Reintroduced

Lawmakers once again are trying to pass legislation to raise public awareness of stroke. Rep. Lois Capps (D-Calif.) and Rep. Chip Pickering (R-Miss.) introduced the Stroke Treatment and Ongoing Prevention Act of 2007 last month. The bill calls for public education efforts to increase awareness of the warning signs of stroke and the need to treat it as a medical emergency. The legislation, H.R. 477, also directs the Health and Human Services secretary to make grants available for developing residency training materials and other continuing education materials for health care providers. It was referred to the House Committee on Energy and Commerce. Dr. Larry Goldstein, chair of the American Stroke Association's Stroke Council, praised the introduction of the legislation and urged the congressional leadership to make the passage of the bill a top priority. Rep. Capps and Sen. Thad Cochran (R-Miss.) introduced similar legislation in the last Congress, but the bills stalled in committee.

FDA Proposes Bovine Ban

Food and Drug Administration officials are proposing to limit the use of cattle materials in drugs and medical devices in an effort to reduce the potential risk of variant Creutzfeldt-Jakob disease. The idea is to keep medical products free of the agent that is believed to cause bovine spongiform encephalopathy. The proposal would cover prescription, over-the-counter, and homeopathic drugs, biologics, and medical devices intended for use in humans; it also includes drugs intended for use in ruminant animals. FDA officials plan to enforce the rules by requiring companies to keep detailed records about which cattle materials were used as ingredients in medical products. At press time, officials at the Pharmaceutical Research and Manufacturers of America were still reviewing the proposal.

More EHRs Obtain Certification

The Certification Commission for Healthcare Information Technology (CCHIT) has given its stamp of approval to 18 more electronic health record products for office-based physicians, bringing the number of certified products to 55, or about 25% of companies in the market, according to a CCHIT estimate. Among the next steps at CCHIT is the expansion of EHR certification to products that cater specifically to certain professional specialties, care settings, and patient populations. “Electronic health record companies have stepped up to the plate, ensuring that their products meet CCHIT criteria and actively promoting certification as a mark of excellence,” Dr. Mark Leavitt, chairman of CCHIT, said in a statement. “The benefits of certification will increase as we continue to raise the standards of functionality, interoperability, and security.” A full list of certified products is available online at

www.cchit.org

Addressing Neurologic Emergencies

The University of Michigan and the National Institutes of Health recently launched the Neurological Emergencies Treatment Trials (NETT) Network, which will be funded by a $7.7 million grant from the NIH's National Institute of Neurological Disorders and Stroke. The University of Michigan, Ann Arbor, will serve as the coordinating center for the network, and is joined by 11 other research hubs at major medical centers. “Our mission is to improve outcomes of patients with acute neurological problems through innovative research focused on patient care that starts in the ambulance and in the emergency department,” Dr. William G. Barsan, chair of the department of emergency medicine at the university, said in a statement. “NETT will give us the framework to test medications, patient management strategies, and other treatments on a large scale and over a short timeframe.” The first NETT trial is scheduled to begin later this year, pending a waiver of informed consent from the Food and Drug Administration, and will focus on patients who experience status epilepticus.

NINDS Gains New Leadership

Neurologist and researcher Dr. Walter J. Koroshetz has been named deputy director of the National Institute of Neurological Disorders and Stroke. Dr. Koroshetz, formerly vice chair of the neurology service and director of stroke and neurointensive care services at Massachusetts General Hospital in Boston, will work on program planning and budgeting in his new post. Dr. Koroshetz has received NINDS extramural funding for his research on Huntington's disease, neuroprotection, and translational research in acute stroke. “Dr. Koroshetz is an internationally renowned neurologist and outstanding investigator and administrator,” NINDS Director Story Landis, Ph.D., said in a statement. “His leadership skills and recognized expertise in stroke, imaging, training, and neurointensive care will serve the Institute well.”

Stroke Legislation Reintroduced

Lawmakers once again are trying to pass legislation to raise public awareness of stroke. Rep. Lois Capps (D-Calif.) and Rep. Chip Pickering (R-Miss.) introduced the Stroke Treatment and Ongoing Prevention Act of 2007 last month. The bill calls for public education efforts to increase awareness of the warning signs of stroke and the need to treat it as a medical emergency. The legislation, H.R. 477, also directs the Health and Human Services secretary to make grants available for developing residency training materials and other continuing education materials for health care providers. It was referred to the House Committee on Energy and Commerce. Dr. Larry Goldstein, chair of the American Stroke Association's Stroke Council, praised the introduction of the legislation and urged the congressional leadership to make the passage of the bill a top priority. Rep. Capps and Sen. Thad Cochran (R-Miss.) introduced similar legislation in the last Congress, but the bills stalled in committee.

FDA Proposes Bovine Ban

Food and Drug Administration officials are proposing to limit the use of cattle materials in drugs and medical devices in an effort to reduce the potential risk of variant Creutzfeldt-Jakob disease. The idea is to keep medical products free of the agent that is believed to cause bovine spongiform encephalopathy. The proposal would cover prescription, over-the-counter, and homeopathic drugs, biologics, and medical devices intended for use in humans; it also includes drugs intended for use in ruminant animals. FDA officials plan to enforce the rules by requiring companies to keep detailed records about which cattle materials were used as ingredients in medical products. At press time, officials at the Pharmaceutical Research and Manufacturers of America were still reviewing the proposal.

More EHRs Obtain Certification

The Certification Commission for Healthcare Information Technology (CCHIT) has given its stamp of approval to 18 more electronic health record products for office-based physicians, bringing the number of certified products to 55, or about 25% of companies in the market, according to a CCHIT estimate. Among the next steps at CCHIT is the expansion of EHR certification to products that cater specifically to certain professional specialties, care settings, and patient populations. “Electronic health record companies have stepped up to the plate, ensuring that their products meet CCHIT criteria and actively promoting certification as a mark of excellence,” Dr. Mark Leavitt, chairman of CCHIT, said in a statement. “The benefits of certification will increase as we continue to raise the standards of functionality, interoperability, and security.” A full list of certified products is available online at

www.cchit.org

Addressing Neurologic Emergencies

The University of Michigan and the National Institutes of Health recently launched the Neurological Emergencies Treatment Trials (NETT) Network, which will be funded by a $7.7 million grant from the NIH's National Institute of Neurological Disorders and Stroke. The University of Michigan, Ann Arbor, will serve as the coordinating center for the network, and is joined by 11 other research hubs at major medical centers. “Our mission is to improve outcomes of patients with acute neurological problems through innovative research focused on patient care that starts in the ambulance and in the emergency department,” Dr. William G. Barsan, chair of the department of emergency medicine at the university, said in a statement. “NETT will give us the framework to test medications, patient management strategies, and other treatments on a large scale and over a short timeframe.” The first NETT trial is scheduled to begin later this year, pending a waiver of informed consent from the Food and Drug Administration, and will focus on patients who experience status epilepticus.

NINDS Gains New Leadership

Neurologist and researcher Dr. Walter J. Koroshetz has been named deputy director of the National Institute of Neurological Disorders and Stroke. Dr. Koroshetz, formerly vice chair of the neurology service and director of stroke and neurointensive care services at Massachusetts General Hospital in Boston, will work on program planning and budgeting in his new post. Dr. Koroshetz has received NINDS extramural funding for his research on Huntington's disease, neuroprotection, and translational research in acute stroke. “Dr. Koroshetz is an internationally renowned neurologist and outstanding investigator and administrator,” NINDS Director Story Landis, Ph.D., said in a statement. “His leadership skills and recognized expertise in stroke, imaging, training, and neurointensive care will serve the Institute well.”

Stroke Legislation Reintroduced

Lawmakers once again are trying to pass legislation to raise public awareness of stroke. Rep. Lois Capps (D-Calif.) and Rep. Chip Pickering (R-Miss.) introduced the Stroke Treatment and Ongoing Prevention Act of 2007 last month. The bill calls for public education efforts to increase awareness of the warning signs of stroke and the need to treat it as a medical emergency. The legislation, H.R. 477, also directs the Health and Human Services secretary to make grants available for developing residency training materials and other continuing education materials for health care providers. It was referred to the House Committee on Energy and Commerce. Dr. Larry Goldstein, chair of the American Stroke Association's Stroke Council, praised the introduction of the legislation and urged the congressional leadership to make the passage of the bill a top priority. Rep. Capps and Sen. Thad Cochran (R-Miss.) introduced similar legislation in the last Congress, but the bills stalled in committee.

FDA Proposes Bovine Ban

Food and Drug Administration officials are proposing to limit the use of cattle materials in drugs and medical devices in an effort to reduce the potential risk of variant Creutzfeldt-Jakob disease. The idea is to keep medical products free of the agent that is believed to cause bovine spongiform encephalopathy. The proposal would cover prescription, over-the-counter, and homeopathic drugs, biologics, and medical devices intended for use in humans; it also includes drugs intended for use in ruminant animals. FDA officials plan to enforce the rules by requiring companies to keep detailed records about which cattle materials were used as ingredients in medical products. At press time, officials at the Pharmaceutical Research and Manufacturers of America were still reviewing the proposal.

More EHRs Obtain Certification

The Certification Commission for Healthcare Information Technology (CCHIT) has given its stamp of approval to 18 more electronic health record products for office-based physicians, bringing the number of certified products to 55, or about 25% of companies in the market, according to a CCHIT estimate. Among the next steps at CCHIT is the expansion of EHR certification to products that cater specifically to certain professional specialties, care settings, and patient populations. “Electronic health record companies have stepped up to the plate, ensuring that their products meet CCHIT criteria and actively promoting certification as a mark of excellence,” Dr. Mark Leavitt, chairman of CCHIT, said in a statement. “The benefits of certification will increase as we continue to raise the standards of functionality, interoperability, and security.” A full list of certified products is available online at

www.cchit.org

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 healthcare 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 healthcare 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 healthcare 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

Officials at the Centers for Medicare and Medicaid Services are proposing to expand coverage for carotid artery stenting to patients younger than 80 years old who are at high risk for carotid endarterectomy and have asymptomatic carotid artery stenosis of 80% or greater.

Under the proposed national coverage determination, a surgeon would perform a consultation to ascertain a patient's high-risk status.

The proposal also spells out coverage for patients 80 years of age and older with either symptomatic stenosis of 70% or greater or asymptomatic stenosis of 80% or greater. Because of safety concerns, carotid artery stenting would be allowed in this group only when it is performed in a Food and Drug Administration Category B Investigational Device Exemption trial, an FDA-approved postapproval study, or under Medicare clinical trial policy.

If finalized the proposal would replace the current CMS coverage policy under which patients at high risk for carotid endarterectomy (CEA) with asymptomatic carotid artery stenosis of greater than 80% can be covered only when carotid artery stenting procedures are performed in an FDA Category B Investigational Device Exemption trial, an FDA-approved postapproval study, or in accordance with Medicare clinical trial policy.

“CMS is committed to providing broader access to appropriate and innovative care to our beneficiaries in the management of their carotid artery disease,” Leslie Norwalk, acting CMS administrator, said in a statement.

Over the last 6 years, CMS officials have expanded coverage of percutaneous transluminal angioplasty and carotid artery stenting in three separate national coverage decisions. Most recently, in November 2006, CMS established Medicare coverage for percutaneous transluminal angioplasty and stenting of intracranial vessels for the treatment of cerebral artery stenosis of 50% or greater in patients with intracranial atherosclerotic disease as part of an FDA-approved Category B clinical trial.

In proposing the expansion of coverage for patients with asymptomatic carotid artery stenosis, CMS relied on evidence from external and internal technology assessments, clinical reviews, and postapproval studies.

Two postapproval studies (CAPTURE and CASES-PMS) showed that carotid artery stenting outcomes were similar by provider experience and in settings outside clinical trials. The trials also did not raise safety concerns about carotid artery stenting in asymptomatic patients with stenosis of 80% or greater, according to CMS.

CMS officials concluded that the evidence is “sufficient” to find that percutaneous transluminal angioplasty with carotid artery stenting improves health outcomes for patients who are at high risk for CEA surgery and have asymptomatic carotid artery stenosis of 80% or greater. However, carotid artery stenting is not covered in the absence of distal embolic protection, even when technical difficulties prevent it from being deployed, according to CMS.

The American Association of Neurological Surgeons was still reviewing the proposed coverage decision at press time. However, in comments to CMS in 2004, the group raised concerns about expanding Medicare coverage for carotid stenting to asymptomatic patients. At that time, the group said that the available data suggested that carotid angioplasty and stenting may be inferior to medical treatment for the prevention of stroke in asymptomatic patients.

At press time, the American College of Cardiology and the Society for Cardiovascular Angiography and Interventions (SCAI) were both also reviewing the CMS coverage proposal. However, Dr. Michael J. Cowley, cochair of the carotid and neurovascular interventions committee for SCAI, said he sees the expansion of coverage as a step in the right direction.

However, he expects that the SCAI committee may have concerns about some aspects of the proposal.

The proposed coverage expansion was also praised by Boston Scientific, which markets the NexStent Carotid Stent and the FilterWire EZ Embolic Protection System. However, the company also said it would like to see broader coverage for high-risk symptomatic patients.

CMS, which is reviewing public comments received prior to the March 3 deadline for comments, is expected to issue a final decision sometime in May.

Officials at the Centers for Medicare and Medicaid Services are proposing to expand coverage for carotid artery stenting to patients younger than 80 years old who are at high risk for carotid endarterectomy and have asymptomatic carotid artery stenosis of 80% or greater.

Under the proposed national coverage determination, a surgeon would perform a consultation to ascertain a patient's high-risk status.

The proposal also spells out coverage for patients 80 years of age and older with either symptomatic stenosis of 70% or greater or asymptomatic stenosis of 80% or greater. Because of safety concerns, carotid artery stenting would be allowed in this group only when it is performed in a Food and Drug Administration Category B Investigational Device Exemption trial, an FDA-approved postapproval study, or under Medicare clinical trial policy.

If finalized the proposal would replace the current CMS coverage policy under which patients at high risk for carotid endarterectomy (CEA) with asymptomatic carotid artery stenosis of greater than 80% can be covered only when carotid artery stenting procedures are performed in an FDA Category B Investigational Device Exemption trial, an FDA-approved postapproval study, or in accordance with Medicare clinical trial policy.

“CMS is committed to providing broader access to appropriate and innovative care to our beneficiaries in the management of their carotid artery disease,” Leslie Norwalk, acting CMS administrator, said in a statement.

Over the last 6 years, CMS officials have expanded coverage of percutaneous transluminal angioplasty and carotid artery stenting in three separate national coverage decisions. Most recently, in November 2006, CMS established Medicare coverage for percutaneous transluminal angioplasty and stenting of intracranial vessels for the treatment of cerebral artery stenosis of 50% or greater in patients with intracranial atherosclerotic disease as part of an FDA-approved Category B clinical trial.

In proposing the expansion of coverage for patients with asymptomatic carotid artery stenosis, CMS relied on evidence from external and internal technology assessments, clinical reviews, and postapproval studies.

Two postapproval studies (CAPTURE and CASES-PMS) showed that carotid artery stenting outcomes were similar by provider experience and in settings outside clinical trials. The trials also did not raise safety concerns about carotid artery stenting in asymptomatic patients with stenosis of 80% or greater, according to CMS.

CMS officials concluded that the evidence is “sufficient” to find that percutaneous transluminal angioplasty with carotid artery stenting improves health outcomes for patients who are at high risk for CEA surgery and have asymptomatic carotid artery stenosis of 80% or greater. However, carotid artery stenting is not covered in the absence of distal embolic protection, even when technical difficulties prevent it from being deployed, according to CMS.

The American Association of Neurological Surgeons was still reviewing the proposed coverage decision at press time. However, in comments to CMS in 2004, the group raised concerns about expanding Medicare coverage for carotid stenting to asymptomatic patients. At that time, the group said that the available data suggested that carotid angioplasty and stenting may be inferior to medical treatment for the prevention of stroke in asymptomatic patients.

At press time, the American College of Cardiology and the Society for Cardiovascular Angiography and Interventions (SCAI) were both also reviewing the CMS coverage proposal. However, Dr. Michael J. Cowley, cochair of the carotid and neurovascular interventions committee for SCAI, said he sees the expansion of coverage as a step in the right direction.

However, he expects that the SCAI committee may have concerns about some aspects of the proposal.

The proposed coverage expansion was also praised by Boston Scientific, which markets the NexStent Carotid Stent and the FilterWire EZ Embolic Protection System. However, the company also said it would like to see broader coverage for high-risk symptomatic patients.

CMS, which is reviewing public comments received prior to the March 3 deadline for comments, is expected to issue a final decision sometime in May.

Officials at the Centers for Medicare and Medicaid Services are proposing to expand coverage for carotid artery stenting to patients younger than 80 years old who are at high risk for carotid endarterectomy and have asymptomatic carotid artery stenosis of 80% or greater.

Under the proposed national coverage determination, a surgeon would perform a consultation to ascertain a patient's high-risk status.

The proposal also spells out coverage for patients 80 years of age and older with either symptomatic stenosis of 70% or greater or asymptomatic stenosis of 80% or greater. Because of safety concerns, carotid artery stenting would be allowed in this group only when it is performed in a Food and Drug Administration Category B Investigational Device Exemption trial, an FDA-approved postapproval study, or under Medicare clinical trial policy.

If finalized the proposal would replace the current CMS coverage policy under which patients at high risk for carotid endarterectomy (CEA) with asymptomatic carotid artery stenosis of greater than 80% can be covered only when carotid artery stenting procedures are performed in an FDA Category B Investigational Device Exemption trial, an FDA-approved postapproval study, or in accordance with Medicare clinical trial policy.

“CMS is committed to providing broader access to appropriate and innovative care to our beneficiaries in the management of their carotid artery disease,” Leslie Norwalk, acting CMS administrator, said in a statement.

Over the last 6 years, CMS officials have expanded coverage of percutaneous transluminal angioplasty and carotid artery stenting in three separate national coverage decisions. Most recently, in November 2006, CMS established Medicare coverage for percutaneous transluminal angioplasty and stenting of intracranial vessels for the treatment of cerebral artery stenosis of 50% or greater in patients with intracranial atherosclerotic disease as part of an FDA-approved Category B clinical trial.

In proposing the expansion of coverage for patients with asymptomatic carotid artery stenosis, CMS relied on evidence from external and internal technology assessments, clinical reviews, and postapproval studies.

Two postapproval studies (CAPTURE and CASES-PMS) showed that carotid artery stenting outcomes were similar by provider experience and in settings outside clinical trials. The trials also did not raise safety concerns about carotid artery stenting in asymptomatic patients with stenosis of 80% or greater, according to CMS.

CMS officials concluded that the evidence is “sufficient” to find that percutaneous transluminal angioplasty with carotid artery stenting improves health outcomes for patients who are at high risk for CEA surgery and have asymptomatic carotid artery stenosis of 80% or greater. However, carotid artery stenting is not covered in the absence of distal embolic protection, even when technical difficulties prevent it from being deployed, according to CMS.

The American Association of Neurological Surgeons was still reviewing the proposed coverage decision at press time. However, in comments to CMS in 2004, the group raised concerns about expanding Medicare coverage for carotid stenting to asymptomatic patients. At that time, the group said that the available data suggested that carotid angioplasty and stenting may be inferior to medical treatment for the prevention of stroke in asymptomatic patients.

At press time, the American College of Cardiology and the Society for Cardiovascular Angiography and Interventions (SCAI) were both also reviewing the CMS coverage proposal. However, Dr. Michael J. Cowley, cochair of the carotid and neurovascular interventions committee for SCAI, said he sees the expansion of coverage as a step in the right direction.

However, he expects that the SCAI committee may have concerns about some aspects of the proposal.

The proposed coverage expansion was also praised by Boston Scientific, which markets the NexStent Carotid Stent and the FilterWire EZ Embolic Protection System. However, the company also said it would like to see broader coverage for high-risk symptomatic patients.

CMS, which is reviewing public comments received prior to the March 3 deadline for comments, is expected to issue a final decision sometime in May.

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 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 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.

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 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 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.

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 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 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.

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.

Arthritis Costs Rose 24% in 7 Years

The total price tag for arthritis and other rheumatic conditions in the United States was approximately $128 billion in 2003, according to the Centers for Disease Control and Prevention. The figure includes $80.8 billion in direct spending on medical treatments and other expenses and $47 billion in indirect costs such as lost wages. The findings were published in the Jan. 12 issue of the Morbidity and Mortality Weekly Report. The researchers estimate that the average per-person direct costs among adults in 2003 were $1,752 and that the average per-person lost earnings totaled $1,590 in 2003. Nursing home costs were excluded from the analysis. The estimates are based on data from the Medical Expenditure Panel Survey, an annual household interview survey. The national direct costs rose 24% between 1997 and 2003 and the researchers attributed the spending growth to the increase in the number of people with arthritis and other rheumatic diseases.

New Osteoporosis Health Claims

Officials at the Food and Drug Administration are proposing to allow a new health claim stating that foods and dietary supplements containing both calcium and vitamin D have the potential to reduce the risk of osteoporosis. The FDA currently allows manufacturers to make only health claims linking calcium intake to a reduced risk of osteoporosis. The new proposal would also broaden the health claim that can be made for products containing calcium by dropping references to sex, race, and age.

ASP Decreases Volume for Some

The switch in 2005 to an average sales price-based payment method for drugs administered in physician offices under Medicare Part B resulted in substantial price savings for the federal program, according to a report from the Medicare Payment Advisory Commission (MedPAC). The ASP-based system led to an increase in claims volume and total charges; even so, some specialists provided fewer drugs in their offices in 2005, according to MedPAC. Overall, Part B drug spending fell from $10.9 billion in 2004 to $10.1 billion in 2005. The commission scrutinized how the switch to ASP affected certain specialists. Urologists cut back the most, giving 16% fewer drugs, leading to a 52% decrease in Medicare spending, mostly for hormones prescribed for prostate cancer. Rheumatologists increased the drug volume—mostly for infliximab—by 9%; Medicare's spending on that drug was constant, however, according to the report. Infectious disease specialists gave 21% fewer drugs in 2005, possibly because physicians shifted their patients to hospital outpatient and postacute care settings, the report said. The change may present some patient access and safety issues, according to MedPAC. But there was no reduction in quality of care in other specialties as a result of the switch to ASP.

New RA Grant Program

The American College of Rheumatology has launched a series of new grants in the area of rheumatoid arthritis. The “Within Our Reach” grants, which are being offered for the first time in 2007, are aimed at funding rheumatologic research that might not be funded by the National Institutes of Health or other peer-review funding sources. Each of the grants is a 2-year award and will be funded at $200,000 a year. The funding for the grants comes from donations to the ACR's Within Our Research: Finding a Cure for Arthritis campaign. The top donors to the campaign include the ACR, Abbott Laboratories, and Bristol-Myers Squibb. More information about the grants is available online at

www.refawards.org/WithinOurReachgrants.asp

Unique New Drugs on Decline

The FDA approved only 18 new molecular entities last year, on par with the previous year but close to a historic low. Throughout the 1980s and 1990s, the agency approved at least 20–30 NMEs annually. Among the 18 were 4 biologic therapies and 4 new vaccines. The paltry number of approvals and a Government Accountability Office report issued in December may point to a decline in new drug development, according to Rep. Henry Waxman (D-Calif.), Sen. Richard Durbin (D-Ill.), and Sen. Edward Kennedy (D-Mass.). The legislators requested the GAO report, which found that huge increases in drug industry research and development from 1993 to 2004 were not accompanied by a similar rise in new drug applications—especially for NMEs—to the FDA. From 1993 to 2004, R&D spending increased 147%; NME applications increased by only 7%. NME applications have declined especially since 1995. “These submission trends indicate that the productivity of research and development investments has declined,” the GAO report said. Backing up that conclusion: Over the same period, the FDA has continued to approve most submissions, but the number approved overall has declined, the GAO said.

Arthritis Costs Rose 24% in 7 Years

The total price tag for arthritis and other rheumatic conditions in the United States was approximately $128 billion in 2003, according to the Centers for Disease Control and Prevention. The figure includes $80.8 billion in direct spending on medical treatments and other expenses and $47 billion in indirect costs such as lost wages. The findings were published in the Jan. 12 issue of the Morbidity and Mortality Weekly Report. The researchers estimate that the average per-person direct costs among adults in 2003 were $1,752 and that the average per-person lost earnings totaled $1,590 in 2003. Nursing home costs were excluded from the analysis. The estimates are based on data from the Medical Expenditure Panel Survey, an annual household interview survey. The national direct costs rose 24% between 1997 and 2003 and the researchers attributed the spending growth to the increase in the number of people with arthritis and other rheumatic diseases.

New Osteoporosis Health Claims

Officials at the Food and Drug Administration are proposing to allow a new health claim stating that foods and dietary supplements containing both calcium and vitamin D have the potential to reduce the risk of osteoporosis. The FDA currently allows manufacturers to make only health claims linking calcium intake to a reduced risk of osteoporosis. The new proposal would also broaden the health claim that can be made for products containing calcium by dropping references to sex, race, and age.

ASP Decreases Volume for Some

The switch in 2005 to an average sales price-based payment method for drugs administered in physician offices under Medicare Part B resulted in substantial price savings for the federal program, according to a report from the Medicare Payment Advisory Commission (MedPAC). The ASP-based system led to an increase in claims volume and total charges; even so, some specialists provided fewer drugs in their offices in 2005, according to MedPAC. Overall, Part B drug spending fell from $10.9 billion in 2004 to $10.1 billion in 2005. The commission scrutinized how the switch to ASP affected certain specialists. Urologists cut back the most, giving 16% fewer drugs, leading to a 52% decrease in Medicare spending, mostly for hormones prescribed for prostate cancer. Rheumatologists increased the drug volume—mostly for infliximab—by 9%; Medicare's spending on that drug was constant, however, according to the report. Infectious disease specialists gave 21% fewer drugs in 2005, possibly because physicians shifted their patients to hospital outpatient and postacute care settings, the report said. The change may present some patient access and safety issues, according to MedPAC. But there was no reduction in quality of care in other specialties as a result of the switch to ASP.

New RA Grant Program

The American College of Rheumatology has launched a series of new grants in the area of rheumatoid arthritis. The “Within Our Reach” grants, which are being offered for the first time in 2007, are aimed at funding rheumatologic research that might not be funded by the National Institutes of Health or other peer-review funding sources. Each of the grants is a 2-year award and will be funded at $200,000 a year. The funding for the grants comes from donations to the ACR's Within Our Research: Finding a Cure for Arthritis campaign. The top donors to the campaign include the ACR, Abbott Laboratories, and Bristol-Myers Squibb. More information about the grants is available online at

www.refawards.org/WithinOurReachgrants.asp

Unique New Drugs on Decline

The FDA approved only 18 new molecular entities last year, on par with the previous year but close to a historic low. Throughout the 1980s and 1990s, the agency approved at least 20–30 NMEs annually. Among the 18 were 4 biologic therapies and 4 new vaccines. The paltry number of approvals and a Government Accountability Office report issued in December may point to a decline in new drug development, according to Rep. Henry Waxman (D-Calif.), Sen. Richard Durbin (D-Ill.), and Sen. Edward Kennedy (D-Mass.). The legislators requested the GAO report, which found that huge increases in drug industry research and development from 1993 to 2004 were not accompanied by a similar rise in new drug applications—especially for NMEs—to the FDA. From 1993 to 2004, R&D spending increased 147%; NME applications increased by only 7%. NME applications have declined especially since 1995. “These submission trends indicate that the productivity of research and development investments has declined,” the GAO report said. Backing up that conclusion: Over the same period, the FDA has continued to approve most submissions, but the number approved overall has declined, the GAO said.

Arthritis Costs Rose 24% in 7 Years

The total price tag for arthritis and other rheumatic conditions in the United States was approximately $128 billion in 2003, according to the Centers for Disease Control and Prevention. The figure includes $80.8 billion in direct spending on medical treatments and other expenses and $47 billion in indirect costs such as lost wages. The findings were published in the Jan. 12 issue of the Morbidity and Mortality Weekly Report. The researchers estimate that the average per-person direct costs among adults in 2003 were $1,752 and that the average per-person lost earnings totaled $1,590 in 2003. Nursing home costs were excluded from the analysis. The estimates are based on data from the Medical Expenditure Panel Survey, an annual household interview survey. The national direct costs rose 24% between 1997 and 2003 and the researchers attributed the spending growth to the increase in the number of people with arthritis and other rheumatic diseases.

New Osteoporosis Health Claims

Officials at the Food and Drug Administration are proposing to allow a new health claim stating that foods and dietary supplements containing both calcium and vitamin D have the potential to reduce the risk of osteoporosis. The FDA currently allows manufacturers to make only health claims linking calcium intake to a reduced risk of osteoporosis. The new proposal would also broaden the health claim that can be made for products containing calcium by dropping references to sex, race, and age.

ASP Decreases Volume for Some

The switch in 2005 to an average sales price-based payment method for drugs administered in physician offices under Medicare Part B resulted in substantial price savings for the federal program, according to a report from the Medicare Payment Advisory Commission (MedPAC). The ASP-based system led to an increase in claims volume and total charges; even so, some specialists provided fewer drugs in their offices in 2005, according to MedPAC. Overall, Part B drug spending fell from $10.9 billion in 2004 to $10.1 billion in 2005. The commission scrutinized how the switch to ASP affected certain specialists. Urologists cut back the most, giving 16% fewer drugs, leading to a 52% decrease in Medicare spending, mostly for hormones prescribed for prostate cancer. Rheumatologists increased the drug volume—mostly for infliximab—by 9%; Medicare's spending on that drug was constant, however, according to the report. Infectious disease specialists gave 21% fewer drugs in 2005, possibly because physicians shifted their patients to hospital outpatient and postacute care settings, the report said. The change may present some patient access and safety issues, according to MedPAC. But there was no reduction in quality of care in other specialties as a result of the switch to ASP.

New RA Grant Program

The American College of Rheumatology has launched a series of new grants in the area of rheumatoid arthritis. The “Within Our Reach” grants, which are being offered for the first time in 2007, are aimed at funding rheumatologic research that might not be funded by the National Institutes of Health or other peer-review funding sources. Each of the grants is a 2-year award and will be funded at $200,000 a year. The funding for the grants comes from donations to the ACR's Within Our Research: Finding a Cure for Arthritis campaign. The top donors to the campaign include the ACR, Abbott Laboratories, and Bristol-Myers Squibb. More information about the grants is available online at

www.refawards.org/WithinOurReachgrants.asp

Unique New Drugs on Decline

The FDA approved only 18 new molecular entities last year, on par with the previous year but close to a historic low. Throughout the 1980s and 1990s, the agency approved at least 20–30 NMEs annually. Among the 18 were 4 biologic therapies and 4 new vaccines. The paltry number of approvals and a Government Accountability Office report issued in December may point to a decline in new drug development, according to Rep. Henry Waxman (D-Calif.), Sen. Richard Durbin (D-Ill.), and Sen. Edward Kennedy (D-Mass.). The legislators requested the GAO report, which found that huge increases in drug industry research and development from 1993 to 2004 were not accompanied by a similar rise in new drug applications—especially for NMEs—to the FDA. From 1993 to 2004, R&D spending increased 147%; NME applications increased by only 7%. NME applications have declined especially since 1995. “These submission trends indicate that the productivity of research and development investments has declined,” the GAO report said. Backing up that conclusion: Over the same period, the FDA has continued to approve most submissions, but the number approved overall has declined, the GAO said.