Alicia Ault

WASHINGTON – A combination of risk factors may be driving a large increase in liver cancer among Latinos in the United States, researchers said at a conference sponsored by the American Association for Cancer Research.

Although liver cancer, or hepatocellular carcinoma (HCC), is most common in Asia and Africa, the incidence is on the rise in the United States, primarily due to hepatitis C virus infection. There are 20,000 new HCC cases in this country each year, and liver cancer is the fifth most common cancer in men and the seventh most common in women, according to a recent review article in the New England Journal of Medicine (2011;365:1118-27).

The main risk factors for HCC in Africa and Asia have been infection with hepatitis B or hepatitis C, and alcoholic liver disease. More recently, evidence has suggested that fatty liver disease and metabolic syndrome may be significant risk factors in Western countries, according to the NEJM review.

In the United States, HCC incidence was 1.7 cases per 100,000 in 1980, but by 2005, this figure had increased to 5 per 100,000, noted the lead author of the Texas study, Amelie Ramirez, Dr.P.H., who presented the data at the conference. Dr. Ramirez, director of the Institute for Health Promotion Research at the University of Texas Health Science Center at San Antonio, and her colleagues decided to see if they could tease out some risk factors for HCC and thereby help to explain the increase among Latinos living in that state.

The investigators used data from the U.S. Surveillance, Epidemiology, and End Results (SEER) program, the Texas Cancer Registry, and the Texas Department of State Health Services. They examined the time period 1995-2006 and calculated age-adjusted and age-specific HCC incidence rates as well as the prevalence of obesity, diabetes, heavy alcohol use, and smoking.

Dr. Ramirez and her colleagues found that Latinos accounted for one third of HCC cases in Texas, and about 75% of cases in South Texas. The rates were 10.6 cases per 100,000 in South Texas and 9.7 per 100,000 in the state, compared with 7.5 per 100,000 among Latinos nationally in the SEER database. About 70% of cases were in men, an observation that held across all three populations – SEER, Texas, and South Texas.

Latinos are the fastest-growing U.S. minority group, accounting for 20% of the total U.S. population and 36% of the population of Texas; by the year 2030, Latinos will constitute a majority of Texas’ census, Dr. Ramirez noted (U.S. Census Bureau, 2010). This pattern is especially pronounced in South Texas, a large region that is currently almost 70% Latino.

The researchers also documented increases in the prevalence of obesity and diabetes among Texas and South Texas Latinos. When they analyzed the time periods 1995-1997 and 2004-2006 separately, the researchers found that obesity for all Latinos increased. During 2004-2006, Texas and South Texas Latinos had higher rates of obesity than U.S. Latinos overall. For U.S. Latinos, the obesity rate was 27%, compared with 30% for Texas Latinos and 35% for South Texas Latinos.

Diabetes prevalence also increased among U.S. Latinos overall, while the prevalence figures for South Texas and Texas Latinos showed increases, but they were not significant.

Heavy alcohol use and smoking did not appear to be significant risk factors for HCC in the analyses. However, the study shows that obesity and diabetes, both of which are preventable and treatable, should receive more attention in the Latino population, especially in Texas, Dr. Ramirez said.

WASHINGTON – A combination of risk factors may be driving a large increase in liver cancer among Latinos in the United States, researchers said at a conference sponsored by the American Association for Cancer Research.

Although liver cancer, or hepatocellular carcinoma (HCC), is most common in Asia and Africa, the incidence is on the rise in the United States, primarily due to hepatitis C virus infection. There are 20,000 new HCC cases in this country each year, and liver cancer is the fifth most common cancer in men and the seventh most common in women, according to a recent review article in the New England Journal of Medicine (2011;365:1118-27).

The main risk factors for HCC in Africa and Asia have been infection with hepatitis B or hepatitis C, and alcoholic liver disease. More recently, evidence has suggested that fatty liver disease and metabolic syndrome may be significant risk factors in Western countries, according to the NEJM review.

In the United States, HCC incidence was 1.7 cases per 100,000 in 1980, but by 2005, this figure had increased to 5 per 100,000, noted the lead author of the Texas study, Amelie Ramirez, Dr.P.H., who presented the data at the conference. Dr. Ramirez, director of the Institute for Health Promotion Research at the University of Texas Health Science Center at San Antonio, and her colleagues decided to see if they could tease out some risk factors for HCC and thereby help to explain the increase among Latinos living in that state.

The investigators used data from the U.S. Surveillance, Epidemiology, and End Results (SEER) program, the Texas Cancer Registry, and the Texas Department of State Health Services. They examined the time period 1995-2006 and calculated age-adjusted and age-specific HCC incidence rates as well as the prevalence of obesity, diabetes, heavy alcohol use, and smoking.

Dr. Ramirez and her colleagues found that Latinos accounted for one third of HCC cases in Texas, and about 75% of cases in South Texas. The rates were 10.6 cases per 100,000 in South Texas and 9.7 per 100,000 in the state, compared with 7.5 per 100,000 among Latinos nationally in the SEER database. About 70% of cases were in men, an observation that held across all three populations – SEER, Texas, and South Texas.

Latinos are the fastest-growing U.S. minority group, accounting for 20% of the total U.S. population and 36% of the population of Texas; by the year 2030, Latinos will constitute a majority of Texas’ census, Dr. Ramirez noted (U.S. Census Bureau, 2010). This pattern is especially pronounced in South Texas, a large region that is currently almost 70% Latino.

The researchers also documented increases in the prevalence of obesity and diabetes among Texas and South Texas Latinos. When they analyzed the time periods 1995-1997 and 2004-2006 separately, the researchers found that obesity for all Latinos increased. During 2004-2006, Texas and South Texas Latinos had higher rates of obesity than U.S. Latinos overall. For U.S. Latinos, the obesity rate was 27%, compared with 30% for Texas Latinos and 35% for South Texas Latinos.

Diabetes prevalence also increased among U.S. Latinos overall, while the prevalence figures for South Texas and Texas Latinos showed increases, but they were not significant.

Heavy alcohol use and smoking did not appear to be significant risk factors for HCC in the analyses. However, the study shows that obesity and diabetes, both of which are preventable and treatable, should receive more attention in the Latino population, especially in Texas, Dr. Ramirez said.

WASHINGTON – A combination of risk factors may be driving a large increase in liver cancer among Latinos in the United States, researchers said at a conference sponsored by the American Association for Cancer Research.

Although liver cancer, or hepatocellular carcinoma (HCC), is most common in Asia and Africa, the incidence is on the rise in the United States, primarily due to hepatitis C virus infection. There are 20,000 new HCC cases in this country each year, and liver cancer is the fifth most common cancer in men and the seventh most common in women, according to a recent review article in the New England Journal of Medicine (2011;365:1118-27).

The main risk factors for HCC in Africa and Asia have been infection with hepatitis B or hepatitis C, and alcoholic liver disease. More recently, evidence has suggested that fatty liver disease and metabolic syndrome may be significant risk factors in Western countries, according to the NEJM review.

In the United States, HCC incidence was 1.7 cases per 100,000 in 1980, but by 2005, this figure had increased to 5 per 100,000, noted the lead author of the Texas study, Amelie Ramirez, Dr.P.H., who presented the data at the conference. Dr. Ramirez, director of the Institute for Health Promotion Research at the University of Texas Health Science Center at San Antonio, and her colleagues decided to see if they could tease out some risk factors for HCC and thereby help to explain the increase among Latinos living in that state.

The investigators used data from the U.S. Surveillance, Epidemiology, and End Results (SEER) program, the Texas Cancer Registry, and the Texas Department of State Health Services. They examined the time period 1995-2006 and calculated age-adjusted and age-specific HCC incidence rates as well as the prevalence of obesity, diabetes, heavy alcohol use, and smoking.

Dr. Ramirez and her colleagues found that Latinos accounted for one third of HCC cases in Texas, and about 75% of cases in South Texas. The rates were 10.6 cases per 100,000 in South Texas and 9.7 per 100,000 in the state, compared with 7.5 per 100,000 among Latinos nationally in the SEER database. About 70% of cases were in men, an observation that held across all three populations – SEER, Texas, and South Texas.

Latinos are the fastest-growing U.S. minority group, accounting for 20% of the total U.S. population and 36% of the population of Texas; by the year 2030, Latinos will constitute a majority of Texas’ census, Dr. Ramirez noted (U.S. Census Bureau, 2010). This pattern is especially pronounced in South Texas, a large region that is currently almost 70% Latino.

The researchers also documented increases in the prevalence of obesity and diabetes among Texas and South Texas Latinos. When they analyzed the time periods 1995-1997 and 2004-2006 separately, the researchers found that obesity for all Latinos increased. During 2004-2006, Texas and South Texas Latinos had higher rates of obesity than U.S. Latinos overall. For U.S. Latinos, the obesity rate was 27%, compared with 30% for Texas Latinos and 35% for South Texas Latinos.

Diabetes prevalence also increased among U.S. Latinos overall, while the prevalence figures for South Texas and Texas Latinos showed increases, but they were not significant.

Heavy alcohol use and smoking did not appear to be significant risk factors for HCC in the analyses. However, the study shows that obesity and diabetes, both of which are preventable and treatable, should receive more attention in the Latino population, especially in Texas, Dr. Ramirez said.

WASHINGTON – Higher levels of stress may partially account for aggressive tumor growth in African American and Hispanic women with breast cancer, according to Garth H. Rauscher, Ph.D., of the University of Illinois at Chicago.

This is one of the first studies to look closely at the potential role of psychosocial stress on tumor progression in breast cancer, said Dr. Rauscher, an associate professor of epidemiology at the university's School of Public Health. However, he acknowledged that the study is “flawed” because it is cross-sectional and has other limitations.

“This is definitely an exploratory study,” Dr. Rauscher said at the meeting.

It was already known, especially in Chicago, that there was a wide disparity in mortality rates between black women and white women, said Dr. Rauscher. The data are not as well defined for Hispanic women, he said.

Tumor aggressiveness likely contributes to higher mortality rates in the minorities. Both African Americans and Hispanics generally have higher-grade tumors and hormone receptor–negative tumors, said Dr. Rauscher. The researchers wanted to investigate why these women have the more aggressive tumor types.

They chose to examine psychosocial factors.

Dr. Rauscher and his colleagues examined associations between patient-reported stress and aggressive breast cancer in a cross-sectional study of 397 non-Hispanic whites, 411 non-Hispanic blacks, and 181 Hispanics. Data were collected through patient interviews and medical record extraction. Stress was assessed using the four-item Cohen Perceived Stress Subscale, the UCLA Loneliness Scale, and the Cockburn psychological consequences scale. The three scales were combined into a single, standardized stress score.

Patients were interviewed just after their diagnosis of breast cancer. Dr. Rauscher explained that the researchers assumed that if patients were experiencing high stress post diagnosis, they were likely to have been under stress before diagnosis as well. But he acknowledged that this assumption is a major limitation of the study.

Of 989 patients, the researchers were able to get tumor grades for 772: 149 had low-grade tumors; 308 were intermediate, and 315 were high-grade tumors. A total of 21% (66 of 315) of patients with high-grade tumors reported elevated stress, 19% (58 of 308) of patients with intermediate-grade tumors reported elevated stress, and 11% (16 of 149) of patients with low-grade tumors reported elevated stress.

The differences were statistically significant, until Dr. Rauscher and his colleagues adjusted for age, treatment, income, and other factors.

A total of 28% of women with hormone receptor–negative tumors reported stress, compared with 14% of those with receptor-positive growths. Patients with hormone receptor–negative disease reported stress one-third of a standard deviation higher than did patients with receptor-positive disease. The difference held up after adjustment, Dr. Rauscher said.

Overall, psychosocial stress scores were higher for black and Hispanic women than for whites.

There's still no way to know, however, what accounts for those differences, said Dr. Rauscher. “If you have a more aggressive diagnosis, does that make you worry more? You could certainly put that out there as a possibility,” he said. Patients with more aggressive disease might also undergo more aggressive treatment, which could also lead to greater stress, he said. “There could be causal arrows going in both directions here, but we can't tease that out.” Even so, he said, “our results are consistent with a role for stress in the etiology of aggressive breast cancer.”

Dr. Rauscher suggested that other researchers could help confirm his work by delving further into existing cohort studies that measured stress and had banked tumor samples. By comparing tumor type to patients reporting stress, they might be able to tease out an association.

Dr. Rauscher reported no conflicts.

View on The News

Which Came First – Stress or Disease?

University of Illinois at Chicago researchers who investigated a possible connection between stress and aggressive breast cancer tumor types offered a healthy reality check along with their results. They point out that their study's results may be flawed by the classic “chicken or egg” dilemma inherent in measuring stress levels following a diagnosis.

Did higher rates of stress instigate or propel tumor growth long term, setting the stage for aggressive disease in these women, or was their elevated stress a normal response to learning that they had an aggressive form of breast cancer, requiring more intensive treatment and a less optimistic prognosis?

The promise in this study is its approach, focusing on the possibility that psychosocial stress plays a role in the development of aggressive breast cancer. It is certainly plausible, and fits with accumulating evidence that stress hormones are associated with prematurity and low birth weight (Int. J. Neurosci 2008; 118:1181), glucose intolerance (Psychoneuroendocrinology 2008;33:517–29. Epub 2008 Mar 11), hand cardiovascular disease (J. Am. Coll. Cardiol. 2008;51:1237–46).

Longitudinal studies, ideally obtaining stress data in healthy subjects prior to diagnoses of cancer and other diseases, could offer illuminating insight in the contribution of psychosocial factors to disease development.

Betsy Bates Freed, Psy.D., is a clinical psychologist in Santa Barbara, Calif., and a medical journalist. She has no relevant financial disclosures.

WASHINGTON – Higher levels of stress may partially account for aggressive tumor growth in African American and Hispanic women with breast cancer, according to Garth H. Rauscher, Ph.D., of the University of Illinois at Chicago.

This is one of the first studies to look closely at the potential role of psychosocial stress on tumor progression in breast cancer, said Dr. Rauscher, an associate professor of epidemiology at the university's School of Public Health. However, he acknowledged that the study is “flawed” because it is cross-sectional and has other limitations.

“This is definitely an exploratory study,” Dr. Rauscher said at the meeting.

It was already known, especially in Chicago, that there was a wide disparity in mortality rates between black women and white women, said Dr. Rauscher. The data are not as well defined for Hispanic women, he said.

Tumor aggressiveness likely contributes to higher mortality rates in the minorities. Both African Americans and Hispanics generally have higher-grade tumors and hormone receptor–negative tumors, said Dr. Rauscher. The researchers wanted to investigate why these women have the more aggressive tumor types.

They chose to examine psychosocial factors.

Dr. Rauscher and his colleagues examined associations between patient-reported stress and aggressive breast cancer in a cross-sectional study of 397 non-Hispanic whites, 411 non-Hispanic blacks, and 181 Hispanics. Data were collected through patient interviews and medical record extraction. Stress was assessed using the four-item Cohen Perceived Stress Subscale, the UCLA Loneliness Scale, and the Cockburn psychological consequences scale. The three scales were combined into a single, standardized stress score.

Patients were interviewed just after their diagnosis of breast cancer. Dr. Rauscher explained that the researchers assumed that if patients were experiencing high stress post diagnosis, they were likely to have been under stress before diagnosis as well. But he acknowledged that this assumption is a major limitation of the study.

Of 989 patients, the researchers were able to get tumor grades for 772: 149 had low-grade tumors; 308 were intermediate, and 315 were high-grade tumors. A total of 21% (66 of 315) of patients with high-grade tumors reported elevated stress, 19% (58 of 308) of patients with intermediate-grade tumors reported elevated stress, and 11% (16 of 149) of patients with low-grade tumors reported elevated stress.

The differences were statistically significant, until Dr. Rauscher and his colleagues adjusted for age, treatment, income, and other factors.

A total of 28% of women with hormone receptor–negative tumors reported stress, compared with 14% of those with receptor-positive growths. Patients with hormone receptor–negative disease reported stress one-third of a standard deviation higher than did patients with receptor-positive disease. The difference held up after adjustment, Dr. Rauscher said.

Overall, psychosocial stress scores were higher for black and Hispanic women than for whites.

There's still no way to know, however, what accounts for those differences, said Dr. Rauscher. “If you have a more aggressive diagnosis, does that make you worry more? You could certainly put that out there as a possibility,” he said. Patients with more aggressive disease might also undergo more aggressive treatment, which could also lead to greater stress, he said. “There could be causal arrows going in both directions here, but we can't tease that out.” Even so, he said, “our results are consistent with a role for stress in the etiology of aggressive breast cancer.”

Dr. Rauscher suggested that other researchers could help confirm his work by delving further into existing cohort studies that measured stress and had banked tumor samples. By comparing tumor type to patients reporting stress, they might be able to tease out an association.

Dr. Rauscher reported no conflicts.

View on The News

Which Came First – Stress or Disease?

University of Illinois at Chicago researchers who investigated a possible connection between stress and aggressive breast cancer tumor types offered a healthy reality check along with their results. They point out that their study's results may be flawed by the classic “chicken or egg” dilemma inherent in measuring stress levels following a diagnosis.

Did higher rates of stress instigate or propel tumor growth long term, setting the stage for aggressive disease in these women, or was their elevated stress a normal response to learning that they had an aggressive form of breast cancer, requiring more intensive treatment and a less optimistic prognosis?

The promise in this study is its approach, focusing on the possibility that psychosocial stress plays a role in the development of aggressive breast cancer. It is certainly plausible, and fits with accumulating evidence that stress hormones are associated with prematurity and low birth weight (Int. J. Neurosci 2008; 118:1181), glucose intolerance (Psychoneuroendocrinology 2008;33:517–29. Epub 2008 Mar 11), hand cardiovascular disease (J. Am. Coll. Cardiol. 2008;51:1237–46).

Longitudinal studies, ideally obtaining stress data in healthy subjects prior to diagnoses of cancer and other diseases, could offer illuminating insight in the contribution of psychosocial factors to disease development.

Betsy Bates Freed, Psy.D., is a clinical psychologist in Santa Barbara, Calif., and a medical journalist. She has no relevant financial disclosures.

WASHINGTON – Higher levels of stress may partially account for aggressive tumor growth in African American and Hispanic women with breast cancer, according to Garth H. Rauscher, Ph.D., of the University of Illinois at Chicago.

This is one of the first studies to look closely at the potential role of psychosocial stress on tumor progression in breast cancer, said Dr. Rauscher, an associate professor of epidemiology at the university's School of Public Health. However, he acknowledged that the study is “flawed” because it is cross-sectional and has other limitations.

“This is definitely an exploratory study,” Dr. Rauscher said at the meeting.

It was already known, especially in Chicago, that there was a wide disparity in mortality rates between black women and white women, said Dr. Rauscher. The data are not as well defined for Hispanic women, he said.

Tumor aggressiveness likely contributes to higher mortality rates in the minorities. Both African Americans and Hispanics generally have higher-grade tumors and hormone receptor–negative tumors, said Dr. Rauscher. The researchers wanted to investigate why these women have the more aggressive tumor types.

They chose to examine psychosocial factors.

Dr. Rauscher and his colleagues examined associations between patient-reported stress and aggressive breast cancer in a cross-sectional study of 397 non-Hispanic whites, 411 non-Hispanic blacks, and 181 Hispanics. Data were collected through patient interviews and medical record extraction. Stress was assessed using the four-item Cohen Perceived Stress Subscale, the UCLA Loneliness Scale, and the Cockburn psychological consequences scale. The three scales were combined into a single, standardized stress score.

Patients were interviewed just after their diagnosis of breast cancer. Dr. Rauscher explained that the researchers assumed that if patients were experiencing high stress post diagnosis, they were likely to have been under stress before diagnosis as well. But he acknowledged that this assumption is a major limitation of the study.

Of 989 patients, the researchers were able to get tumor grades for 772: 149 had low-grade tumors; 308 were intermediate, and 315 were high-grade tumors. A total of 21% (66 of 315) of patients with high-grade tumors reported elevated stress, 19% (58 of 308) of patients with intermediate-grade tumors reported elevated stress, and 11% (16 of 149) of patients with low-grade tumors reported elevated stress.

The differences were statistically significant, until Dr. Rauscher and his colleagues adjusted for age, treatment, income, and other factors.

A total of 28% of women with hormone receptor–negative tumors reported stress, compared with 14% of those with receptor-positive growths. Patients with hormone receptor–negative disease reported stress one-third of a standard deviation higher than did patients with receptor-positive disease. The difference held up after adjustment, Dr. Rauscher said.

Overall, psychosocial stress scores were higher for black and Hispanic women than for whites.

There's still no way to know, however, what accounts for those differences, said Dr. Rauscher. “If you have a more aggressive diagnosis, does that make you worry more? You could certainly put that out there as a possibility,” he said. Patients with more aggressive disease might also undergo more aggressive treatment, which could also lead to greater stress, he said. “There could be causal arrows going in both directions here, but we can't tease that out.” Even so, he said, “our results are consistent with a role for stress in the etiology of aggressive breast cancer.”

Dr. Rauscher suggested that other researchers could help confirm his work by delving further into existing cohort studies that measured stress and had banked tumor samples. By comparing tumor type to patients reporting stress, they might be able to tease out an association.

Dr. Rauscher reported no conflicts.

View on The News

Which Came First – Stress or Disease?

University of Illinois at Chicago researchers who investigated a possible connection between stress and aggressive breast cancer tumor types offered a healthy reality check along with their results. They point out that their study's results may be flawed by the classic “chicken or egg” dilemma inherent in measuring stress levels following a diagnosis.

Did higher rates of stress instigate or propel tumor growth long term, setting the stage for aggressive disease in these women, or was their elevated stress a normal response to learning that they had an aggressive form of breast cancer, requiring more intensive treatment and a less optimistic prognosis?

The promise in this study is its approach, focusing on the possibility that psychosocial stress plays a role in the development of aggressive breast cancer. It is certainly plausible, and fits with accumulating evidence that stress hormones are associated with prematurity and low birth weight (Int. J. Neurosci 2008; 118:1181), glucose intolerance (Psychoneuroendocrinology 2008;33:517–29. Epub 2008 Mar 11), hand cardiovascular disease (J. Am. Coll. Cardiol. 2008;51:1237–46).

Longitudinal studies, ideally obtaining stress data in healthy subjects prior to diagnoses of cancer and other diseases, could offer illuminating insight in the contribution of psychosocial factors to disease development.

Betsy Bates Freed, Psy.D., is a clinical psychologist in Santa Barbara, Calif., and a medical journalist. She has no relevant financial disclosures.

Medicare will begin rewarding primary care physicians for spending more time with patients and offering services such as late hours and intensive care management beginning next summer, under a new program unveiled Sept. 28.

The Primary Care Initiative aims to pay primary care physicians for services that they currently might not have time to provide or aren't getting paid for, such as creating a care plan, reviewing test results on the phone, or helping patients closely manage cholesterol or weight, Dr. Richard Baron, director of the seamless care models group at the Centers for Medicare and Medicaid Services (CMS), said during a telephone briefing with reporters.

Some physician groups welcomed the announcement. The initiative “offers enormous potential to promote the kind of personalized and coordinated care that patients seek and that physicians want to deliver,” Dr. Steven Weinberger, executive vice president and chief executive officer of the American College of Physicians, said in a statement. The program “will provide primary care physicians with the support needed to work hand-in-hand with patients toward a shared goal of ensuring high-quality care while making the most efficient use of health care resources.”

The initiative is being funded by the Affordable Care Act, Dr. Baron said.

“Instead of being paid for doing more procedures and squeezing more patients into each day, primary care practices will receive payments for being accessible after hours or using electronic health records to make sure care is well coordinated,” Health and Human Services Secretary Kathleen Sebelius said during the briefing. “For patients, it means valuable extra time with their doctors, to understand their conditions and talk about how to lead healthier lives.”

The program aims to recognize the ability of primary care to lower costs and improve health outcomes, Dr. Baron said. Some insurers and self-insured companies have started making similar payments for enhanced primary care services.

Dick Wilkerson, chairman and president of Michelin North America, said that his company has seen a huge decrease in health costs by covering 100% of preventive care services and 100% of care for people with chronic conditions, as well as making primary care services available on-site at two of its major facilities. Primary care physicians are required to spend a minimum of 20 minutes with each Michelin patient, he said.

The company has had a big reduction in emergency department visits, hospitalizations, and high-cost claims, he said.

WellPoint has also been testing bonus payments and coordinated care models in nine of its Blue Cross Blue Shield plans, said Dr. Sam Nussbaum, WellPoint chief medical officer. Participating medical practices offer on-site care managers and 24/7 access for members. There has been a 4%-6% reduction in hospitalizations, rehospitalizations, and emergency department visits, he said.

The agency is seeking letters of intent from private insurers and other payers by Nov. 15; final applications are due by Jan. 17. After the CMS has identified the markets where there will be a critical mass of Medicare and private pay patients covered by the incentives, the agency will solicit participation from primary care physicians. The aim is to be in five to seven markets with 75 physician practices participating.

Physicians who meet the program goals will be eligible to receive $20 per Medicare beneficiary per month for the first 2 years of the program. The payment will be reduced to $15 for the second 2 years.

It will be up to the practices to determine how they can best manage patients for that incentive, said Dr. Richard Gilfillan, acting director of the CMS Innovation Center. But, he and Dr. Baron noted that the CMS will be available to help physician practices with data and other support to make the initiative work for them.

Medicare will begin rewarding primary care physicians for spending more time with patients and offering services such as late hours and intensive care management beginning next summer, under a new program unveiled Sept. 28.

The Primary Care Initiative aims to pay primary care physicians for services that they currently might not have time to provide or aren't getting paid for, such as creating a care plan, reviewing test results on the phone, or helping patients closely manage cholesterol or weight, Dr. Richard Baron, director of the seamless care models group at the Centers for Medicare and Medicaid Services (CMS), said during a telephone briefing with reporters.

Some physician groups welcomed the announcement. The initiative “offers enormous potential to promote the kind of personalized and coordinated care that patients seek and that physicians want to deliver,” Dr. Steven Weinberger, executive vice president and chief executive officer of the American College of Physicians, said in a statement. The program “will provide primary care physicians with the support needed to work hand-in-hand with patients toward a shared goal of ensuring high-quality care while making the most efficient use of health care resources.”

The initiative is being funded by the Affordable Care Act, Dr. Baron said.

“Instead of being paid for doing more procedures and squeezing more patients into each day, primary care practices will receive payments for being accessible after hours or using electronic health records to make sure care is well coordinated,” Health and Human Services Secretary Kathleen Sebelius said during the briefing. “For patients, it means valuable extra time with their doctors, to understand their conditions and talk about how to lead healthier lives.”

The program aims to recognize the ability of primary care to lower costs and improve health outcomes, Dr. Baron said. Some insurers and self-insured companies have started making similar payments for enhanced primary care services.

Dick Wilkerson, chairman and president of Michelin North America, said that his company has seen a huge decrease in health costs by covering 100% of preventive care services and 100% of care for people with chronic conditions, as well as making primary care services available on-site at two of its major facilities. Primary care physicians are required to spend a minimum of 20 minutes with each Michelin patient, he said.

The company has had a big reduction in emergency department visits, hospitalizations, and high-cost claims, he said.

WellPoint has also been testing bonus payments and coordinated care models in nine of its Blue Cross Blue Shield plans, said Dr. Sam Nussbaum, WellPoint chief medical officer. Participating medical practices offer on-site care managers and 24/7 access for members. There has been a 4%-6% reduction in hospitalizations, rehospitalizations, and emergency department visits, he said.

The agency is seeking letters of intent from private insurers and other payers by Nov. 15; final applications are due by Jan. 17. After the CMS has identified the markets where there will be a critical mass of Medicare and private pay patients covered by the incentives, the agency will solicit participation from primary care physicians. The aim is to be in five to seven markets with 75 physician practices participating.

Physicians who meet the program goals will be eligible to receive $20 per Medicare beneficiary per month for the first 2 years of the program. The payment will be reduced to $15 for the second 2 years.

It will be up to the practices to determine how they can best manage patients for that incentive, said Dr. Richard Gilfillan, acting director of the CMS Innovation Center. But, he and Dr. Baron noted that the CMS will be available to help physician practices with data and other support to make the initiative work for them.

Medicare will begin rewarding primary care physicians for spending more time with patients and offering services such as late hours and intensive care management beginning next summer, under a new program unveiled Sept. 28.

The Primary Care Initiative aims to pay primary care physicians for services that they currently might not have time to provide or aren't getting paid for, such as creating a care plan, reviewing test results on the phone, or helping patients closely manage cholesterol or weight, Dr. Richard Baron, director of the seamless care models group at the Centers for Medicare and Medicaid Services (CMS), said during a telephone briefing with reporters.

Some physician groups welcomed the announcement. The initiative “offers enormous potential to promote the kind of personalized and coordinated care that patients seek and that physicians want to deliver,” Dr. Steven Weinberger, executive vice president and chief executive officer of the American College of Physicians, said in a statement. The program “will provide primary care physicians with the support needed to work hand-in-hand with patients toward a shared goal of ensuring high-quality care while making the most efficient use of health care resources.”

The initiative is being funded by the Affordable Care Act, Dr. Baron said.

“Instead of being paid for doing more procedures and squeezing more patients into each day, primary care practices will receive payments for being accessible after hours or using electronic health records to make sure care is well coordinated,” Health and Human Services Secretary Kathleen Sebelius said during the briefing. “For patients, it means valuable extra time with their doctors, to understand their conditions and talk about how to lead healthier lives.”

The program aims to recognize the ability of primary care to lower costs and improve health outcomes, Dr. Baron said. Some insurers and self-insured companies have started making similar payments for enhanced primary care services.

Dick Wilkerson, chairman and president of Michelin North America, said that his company has seen a huge decrease in health costs by covering 100% of preventive care services and 100% of care for people with chronic conditions, as well as making primary care services available on-site at two of its major facilities. Primary care physicians are required to spend a minimum of 20 minutes with each Michelin patient, he said.

The company has had a big reduction in emergency department visits, hospitalizations, and high-cost claims, he said.

WellPoint has also been testing bonus payments and coordinated care models in nine of its Blue Cross Blue Shield plans, said Dr. Sam Nussbaum, WellPoint chief medical officer. Participating medical practices offer on-site care managers and 24/7 access for members. There has been a 4%-6% reduction in hospitalizations, rehospitalizations, and emergency department visits, he said.

The agency is seeking letters of intent from private insurers and other payers by Nov. 15; final applications are due by Jan. 17. After the CMS has identified the markets where there will be a critical mass of Medicare and private pay patients covered by the incentives, the agency will solicit participation from primary care physicians. The aim is to be in five to seven markets with 75 physician practices participating.

Physicians who meet the program goals will be eligible to receive $20 per Medicare beneficiary per month for the first 2 years of the program. The payment will be reduced to $15 for the second 2 years.

It will be up to the practices to determine how they can best manage patients for that incentive, said Dr. Richard Gilfillan, acting director of the CMS Innovation Center. But, he and Dr. Baron noted that the CMS will be available to help physician practices with data and other support to make the initiative work for them.

The Joint Commission issued a list of what it is designating as the top-performing hospitals in America, and the facilities that are not listed might be somewhat surprising.

Missing from the list of the “best of the best,” a new designation this year, are Johns Hopkins, Duke, the Cleveland Clinic, the Mayo Clinic, M.D. Anderson, and even the Geisinger Health System, which has been hailed as a quality pioneer.

Out of the 3,000 hospitals for which the Joint Commission has been collecting performance data on for the last decade, 405 met the top performance criteria for data reported in 2010. They represent only 14% of the universe of facilities that the Joint Commission accredits.

These hospitals had a 95% score on a composite measure for all 22 performance measures for heart attack, heart failure, pneumonia, surgical care, and children's asthma care. The hospitals also met a second 95% target for each individual measure, which means “a hospital provided an evidence-based practice 95 times out of 100 opportunities to provide the practice,” according to the Joint Commission.

The 405 that made the cut were primarily smaller and rural. Dr. Mark R. Chassin, president of the Joint Commission, in a briefing with reporters, was asked why some of the bigger and better-known academic and urban medical centers, all having stellar reputations, did not achieve the ranking of a top performer.

“I would suggest asking [those hospitals] why they think they're not on the list,” he replied, noting that “Reputation and performance on important measures of quality don't often go together.”

Dr. Chassin said that the Commission's use of process measures, instead of outcomes measures, was the best way to determine quality of care. “The criteria we've come up with are designed to make sure that the processes we measure and the measures we use to measure them focus on processes that have an extremely high likelihood of creating good outcomes,” he said.

Overall, hospitals are doing much better at meeting these measures, said Dr. Chassin. But he added, “Hospitals can and should do better.”

Among the improvements tallied by the Joint Commission in its annual report on quality:

P Hospitals provided an evidence-based heart attack treatment 984 times for every 1,000 opportunities to do so, for a composite score of 98.4%. That's up from 86.9% in 2002.

P The pneumonia care score rose from 72.3% in 2002 to 95.2%.

P The surgical care score improved from 82.1% in 2005 (when it was added) to 96.4%.

P The children's asthma care composite rose from 79.8% in 2008 to 92.3% in 2010.

P A total of 91.7% of hospitals achieved 90% or better on the overall composite score, up from just 26.2% in 2002.

View on the News

Quality Is in Outcomes, Not Process

Given that the “quality” we are talking about here is measured by process documentation (not actual outcomes), the smaller the hospital and number of documenting physicians, the more likely you are to see percentages of “quality” in the upper echelons. In other words, the process may be occurring in the larger hospitals, it is just not getting documented as such … smaller hospitals can create uniform documentation standards a lot faster than larger hospitals.

It is a bit disingenuous for Dr. Chassin to suggest that reputation and performance do not often go together.

In the case of the Cleveland Clinic, Johns Hopkins, Duke, and other similar centers, it most certainly does and has been demonstrated in direct outcomes measurement.

You will notice that Lakewood Hospital in Lakewood, Ohio, is the only Cleveland-area hospital that is in the upper echelon in process measurement for acute myocardial infarction as listed by the Joint Commission (as it is, Lakewood Hospital is owned by the Cleveland Clinic and is a member of the Cleveland Clinic Health System), but if, because of this “best of the best” list, a complicated patient with an acute MI chooses to go to Lakewood Hospital over going to a tertiary center with outcomes reported as good as the Cleveland Clinic main campus, then the Joint Commission should be ashamed of itself.

FRANKLIN A. MICHOTA, M.D., is director of academic affairs in the department of hospital medicine at the Cleveland Clinic.

Vitals

The Joint Commission issued a list of what it is designating as the top-performing hospitals in America, and the facilities that are not listed might be somewhat surprising.

Missing from the list of the “best of the best,” a new designation this year, are Johns Hopkins, Duke, the Cleveland Clinic, the Mayo Clinic, M.D. Anderson, and even the Geisinger Health System, which has been hailed as a quality pioneer.

Out of the 3,000 hospitals for which the Joint Commission has been collecting performance data on for the last decade, 405 met the top performance criteria for data reported in 2010. They represent only 14% of the universe of facilities that the Joint Commission accredits.

These hospitals had a 95% score on a composite measure for all 22 performance measures for heart attack, heart failure, pneumonia, surgical care, and children's asthma care. The hospitals also met a second 95% target for each individual measure, which means “a hospital provided an evidence-based practice 95 times out of 100 opportunities to provide the practice,” according to the Joint Commission.

The 405 that made the cut were primarily smaller and rural. Dr. Mark R. Chassin, president of the Joint Commission, in a briefing with reporters, was asked why some of the bigger and better-known academic and urban medical centers, all having stellar reputations, did not achieve the ranking of a top performer.

“I would suggest asking [those hospitals] why they think they're not on the list,” he replied, noting that “Reputation and performance on important measures of quality don't often go together.”

Dr. Chassin said that the Commission's use of process measures, instead of outcomes measures, was the best way to determine quality of care. “The criteria we've come up with are designed to make sure that the processes we measure and the measures we use to measure them focus on processes that have an extremely high likelihood of creating good outcomes,” he said.

Overall, hospitals are doing much better at meeting these measures, said Dr. Chassin. But he added, “Hospitals can and should do better.”

Among the improvements tallied by the Joint Commission in its annual report on quality:

P Hospitals provided an evidence-based heart attack treatment 984 times for every 1,000 opportunities to do so, for a composite score of 98.4%. That's up from 86.9% in 2002.

P The pneumonia care score rose from 72.3% in 2002 to 95.2%.

P The surgical care score improved from 82.1% in 2005 (when it was added) to 96.4%.

P The children's asthma care composite rose from 79.8% in 2008 to 92.3% in 2010.

P A total of 91.7% of hospitals achieved 90% or better on the overall composite score, up from just 26.2% in 2002.

View on the News

Quality Is in Outcomes, Not Process

Given that the “quality” we are talking about here is measured by process documentation (not actual outcomes), the smaller the hospital and number of documenting physicians, the more likely you are to see percentages of “quality” in the upper echelons. In other words, the process may be occurring in the larger hospitals, it is just not getting documented as such … smaller hospitals can create uniform documentation standards a lot faster than larger hospitals.

It is a bit disingenuous for Dr. Chassin to suggest that reputation and performance do not often go together.

In the case of the Cleveland Clinic, Johns Hopkins, Duke, and other similar centers, it most certainly does and has been demonstrated in direct outcomes measurement.

You will notice that Lakewood Hospital in Lakewood, Ohio, is the only Cleveland-area hospital that is in the upper echelon in process measurement for acute myocardial infarction as listed by the Joint Commission (as it is, Lakewood Hospital is owned by the Cleveland Clinic and is a member of the Cleveland Clinic Health System), but if, because of this “best of the best” list, a complicated patient with an acute MI chooses to go to Lakewood Hospital over going to a tertiary center with outcomes reported as good as the Cleveland Clinic main campus, then the Joint Commission should be ashamed of itself.

FRANKLIN A. MICHOTA, M.D., is director of academic affairs in the department of hospital medicine at the Cleveland Clinic.

Vitals

The Joint Commission issued a list of what it is designating as the top-performing hospitals in America, and the facilities that are not listed might be somewhat surprising.

Missing from the list of the “best of the best,” a new designation this year, are Johns Hopkins, Duke, the Cleveland Clinic, the Mayo Clinic, M.D. Anderson, and even the Geisinger Health System, which has been hailed as a quality pioneer.

Out of the 3,000 hospitals for which the Joint Commission has been collecting performance data on for the last decade, 405 met the top performance criteria for data reported in 2010. They represent only 14% of the universe of facilities that the Joint Commission accredits.

These hospitals had a 95% score on a composite measure for all 22 performance measures for heart attack, heart failure, pneumonia, surgical care, and children's asthma care. The hospitals also met a second 95% target for each individual measure, which means “a hospital provided an evidence-based practice 95 times out of 100 opportunities to provide the practice,” according to the Joint Commission.

The 405 that made the cut were primarily smaller and rural. Dr. Mark R. Chassin, president of the Joint Commission, in a briefing with reporters, was asked why some of the bigger and better-known academic and urban medical centers, all having stellar reputations, did not achieve the ranking of a top performer.

“I would suggest asking [those hospitals] why they think they're not on the list,” he replied, noting that “Reputation and performance on important measures of quality don't often go together.”

Dr. Chassin said that the Commission's use of process measures, instead of outcomes measures, was the best way to determine quality of care. “The criteria we've come up with are designed to make sure that the processes we measure and the measures we use to measure them focus on processes that have an extremely high likelihood of creating good outcomes,” he said.

Overall, hospitals are doing much better at meeting these measures, said Dr. Chassin. But he added, “Hospitals can and should do better.”

Among the improvements tallied by the Joint Commission in its annual report on quality:

P Hospitals provided an evidence-based heart attack treatment 984 times for every 1,000 opportunities to do so, for a composite score of 98.4%. That's up from 86.9% in 2002.

P The pneumonia care score rose from 72.3% in 2002 to 95.2%.

P The surgical care score improved from 82.1% in 2005 (when it was added) to 96.4%.

P The children's asthma care composite rose from 79.8% in 2008 to 92.3% in 2010.

P A total of 91.7% of hospitals achieved 90% or better on the overall composite score, up from just 26.2% in 2002.

View on the News

Quality Is in Outcomes, Not Process

Given that the “quality” we are talking about here is measured by process documentation (not actual outcomes), the smaller the hospital and number of documenting physicians, the more likely you are to see percentages of “quality” in the upper echelons. In other words, the process may be occurring in the larger hospitals, it is just not getting documented as such … smaller hospitals can create uniform documentation standards a lot faster than larger hospitals.

It is a bit disingenuous for Dr. Chassin to suggest that reputation and performance do not often go together.

In the case of the Cleveland Clinic, Johns Hopkins, Duke, and other similar centers, it most certainly does and has been demonstrated in direct outcomes measurement.

You will notice that Lakewood Hospital in Lakewood, Ohio, is the only Cleveland-area hospital that is in the upper echelon in process measurement for acute myocardial infarction as listed by the Joint Commission (as it is, Lakewood Hospital is owned by the Cleveland Clinic and is a member of the Cleveland Clinic Health System), but if, because of this “best of the best” list, a complicated patient with an acute MI chooses to go to Lakewood Hospital over going to a tertiary center with outcomes reported as good as the Cleveland Clinic main campus, then the Joint Commission should be ashamed of itself.

FRANKLIN A. MICHOTA, M.D., is director of academic affairs in the department of hospital medicine at the Cleveland Clinic.

Vitals

Major Finding: Almost half of primary care physicians responding to a randomized survey said that they practice too aggressively; 76% said the overtreatment stems from malpractice fears.

Data Source: A survey of 627 primary care physicians randomly sampled from the AMA Physician Masterfile; 70% of physicians responded.

Disclosures: The study was supported by grants from the Department of Veterans Affairs and the National Institute of Aging. The authors reported no relevant financial conflicts of interest.

Forty-two percent of physicians admit that patients in their practices receive too much treatment, which was described as “aggressive” care, according to a survey of general internists and family doctors. Fifty-two percent said that they thought the amount of care they provided was just right, and 6% said their patients received too little care.

When asked about their own practice style, 28% of respondents said they were too aggressive, ordering more tests and referrals than necessary. Just under 20% said they were practicing more conservatively than their ideal (Arch. Intern. Med. 2011;171:1582-5).

The doctors were also asked to describe practice styles among other health care providers and reported that they believed they saw too much testing and ordering of referrals by nurse practitioners, physician assistants, and specialists.

Twenty-nine percent said other primary care physicians were practicing too aggressively, while 61% said they believed that specialists are too aggressive in their practice and 47% said mid-level providers overtreat patients.

Malpractice concerns were cited by 76% of the survey respondents as a reason for their more aggressive practice style. Eighty-three percent of the physicians said that they feared being sued if they did not order an indicated test.

About half of those surveyed said that clinical performance measures led to more care, and 40% said that not having enough time with patients translated into a more aggressive practice. Instead of thinking through an issue, they order tests or make referrals.

Few physicians (3%) said that they believed financial considerations influenced how they personally practiced medicine. But 39% said they thought other primary care doctors would order fewer tests if there was no incentive. Sixty-two percent said that specialists would likely perform fewer procedures if they did not generate extra revenue.

The survey authors, led by Dr. Brenda E. Sirovich of the VA Outcomes Group, White River Junction, Vt., said that while many have debated just how much the fear of malpractice leads to more aggressive care, “based on our findings, we believe it is not a small effect.”

“Our work shows that primary care physicians recognize the excesses of our health care system, can point clearly to some of the causes, and may be open to changing their own practices to address them,” according to Dr. Sirovich and her associates.

The authors mailed a nine-page survey to primary care physicians, asking them to describe how they and their colleagues practiced medicine. A total of 627 physicians were randomly sampled from the American Medical Association's Physician Masterfile; 70% responded.

Most survey respondents were male, board certified, and reported a median of 24 years in practice.

Surveyed physicians were provided with an honorarium of $20-$100 for their participation.

View on the News

Defensive Medicine Is a Dead-End

“Implicit in these findings is a kind of trained helplessness – it seems that physicians know they are practicing aggressively but feel they have no recourse,” Dr. Calvin Chou wrote in an invited commentary.

Dr. Chou suggests that defensive medicine is a dead-end; it is not a sustainable practice and there is no evidence that it actually prevents malpractice suits.

Instead, studies have shown that physicians sued the least are the ones who connect more with patients by actively listening and including them in their own care.

“Patients tend to define quality of care in terms of the quality of communication with members of their health care team,” Dr. Chou wrote.

Dr. Chou is a professor of medicine at the University of California, San Francisco. These comments were adapted from a commentary accompanying the report (Arch. Intl. Med. 2011;171:1585-6). He reported no relevant financial conflicts of interest.

Major Finding: Almost half of primary care physicians responding to a randomized survey said that they practice too aggressively; 76% said the overtreatment stems from malpractice fears.

Data Source: A survey of 627 primary care physicians randomly sampled from the AMA Physician Masterfile; 70% of physicians responded.

Disclosures: The study was supported by grants from the Department of Veterans Affairs and the National Institute of Aging. The authors reported no relevant financial conflicts of interest.

Forty-two percent of physicians admit that patients in their practices receive too much treatment, which was described as “aggressive” care, according to a survey of general internists and family doctors. Fifty-two percent said that they thought the amount of care they provided was just right, and 6% said their patients received too little care.

When asked about their own practice style, 28% of respondents said they were too aggressive, ordering more tests and referrals than necessary. Just under 20% said they were practicing more conservatively than their ideal (Arch. Intern. Med. 2011;171:1582-5).

The doctors were also asked to describe practice styles among other health care providers and reported that they believed they saw too much testing and ordering of referrals by nurse practitioners, physician assistants, and specialists.

Twenty-nine percent said other primary care physicians were practicing too aggressively, while 61% said they believed that specialists are too aggressive in their practice and 47% said mid-level providers overtreat patients.

Malpractice concerns were cited by 76% of the survey respondents as a reason for their more aggressive practice style. Eighty-three percent of the physicians said that they feared being sued if they did not order an indicated test.

About half of those surveyed said that clinical performance measures led to more care, and 40% said that not having enough time with patients translated into a more aggressive practice. Instead of thinking through an issue, they order tests or make referrals.

Few physicians (3%) said that they believed financial considerations influenced how they personally practiced medicine. But 39% said they thought other primary care doctors would order fewer tests if there was no incentive. Sixty-two percent said that specialists would likely perform fewer procedures if they did not generate extra revenue.

The survey authors, led by Dr. Brenda E. Sirovich of the VA Outcomes Group, White River Junction, Vt., said that while many have debated just how much the fear of malpractice leads to more aggressive care, “based on our findings, we believe it is not a small effect.”

“Our work shows that primary care physicians recognize the excesses of our health care system, can point clearly to some of the causes, and may be open to changing their own practices to address them,” according to Dr. Sirovich and her associates.

The authors mailed a nine-page survey to primary care physicians, asking them to describe how they and their colleagues practiced medicine. A total of 627 physicians were randomly sampled from the American Medical Association's Physician Masterfile; 70% responded.

Most survey respondents were male, board certified, and reported a median of 24 years in practice.

Surveyed physicians were provided with an honorarium of $20-$100 for their participation.

View on the News

Defensive Medicine Is a Dead-End

“Implicit in these findings is a kind of trained helplessness – it seems that physicians know they are practicing aggressively but feel they have no recourse,” Dr. Calvin Chou wrote in an invited commentary.

Dr. Chou suggests that defensive medicine is a dead-end; it is not a sustainable practice and there is no evidence that it actually prevents malpractice suits.

Instead, studies have shown that physicians sued the least are the ones who connect more with patients by actively listening and including them in their own care.

“Patients tend to define quality of care in terms of the quality of communication with members of their health care team,” Dr. Chou wrote.

Dr. Chou is a professor of medicine at the University of California, San Francisco. These comments were adapted from a commentary accompanying the report (Arch. Intl. Med. 2011;171:1585-6). He reported no relevant financial conflicts of interest.

Major Finding: Almost half of primary care physicians responding to a randomized survey said that they practice too aggressively; 76% said the overtreatment stems from malpractice fears.

Data Source: A survey of 627 primary care physicians randomly sampled from the AMA Physician Masterfile; 70% of physicians responded.

Disclosures: The study was supported by grants from the Department of Veterans Affairs and the National Institute of Aging. The authors reported no relevant financial conflicts of interest.

Forty-two percent of physicians admit that patients in their practices receive too much treatment, which was described as “aggressive” care, according to a survey of general internists and family doctors. Fifty-two percent said that they thought the amount of care they provided was just right, and 6% said their patients received too little care.

When asked about their own practice style, 28% of respondents said they were too aggressive, ordering more tests and referrals than necessary. Just under 20% said they were practicing more conservatively than their ideal (Arch. Intern. Med. 2011;171:1582-5).

The doctors were also asked to describe practice styles among other health care providers and reported that they believed they saw too much testing and ordering of referrals by nurse practitioners, physician assistants, and specialists.

Twenty-nine percent said other primary care physicians were practicing too aggressively, while 61% said they believed that specialists are too aggressive in their practice and 47% said mid-level providers overtreat patients.

Malpractice concerns were cited by 76% of the survey respondents as a reason for their more aggressive practice style. Eighty-three percent of the physicians said that they feared being sued if they did not order an indicated test.

About half of those surveyed said that clinical performance measures led to more care, and 40% said that not having enough time with patients translated into a more aggressive practice. Instead of thinking through an issue, they order tests or make referrals.

Few physicians (3%) said that they believed financial considerations influenced how they personally practiced medicine. But 39% said they thought other primary care doctors would order fewer tests if there was no incentive. Sixty-two percent said that specialists would likely perform fewer procedures if they did not generate extra revenue.

The survey authors, led by Dr. Brenda E. Sirovich of the VA Outcomes Group, White River Junction, Vt., said that while many have debated just how much the fear of malpractice leads to more aggressive care, “based on our findings, we believe it is not a small effect.”

“Our work shows that primary care physicians recognize the excesses of our health care system, can point clearly to some of the causes, and may be open to changing their own practices to address them,” according to Dr. Sirovich and her associates.

The authors mailed a nine-page survey to primary care physicians, asking them to describe how they and their colleagues practiced medicine. A total of 627 physicians were randomly sampled from the American Medical Association's Physician Masterfile; 70% responded.

Most survey respondents were male, board certified, and reported a median of 24 years in practice.

Surveyed physicians were provided with an honorarium of $20-$100 for their participation.

View on the News

Defensive Medicine Is a Dead-End

“Implicit in these findings is a kind of trained helplessness – it seems that physicians know they are practicing aggressively but feel they have no recourse,” Dr. Calvin Chou wrote in an invited commentary.

Dr. Chou suggests that defensive medicine is a dead-end; it is not a sustainable practice and there is no evidence that it actually prevents malpractice suits.

Instead, studies have shown that physicians sued the least are the ones who connect more with patients by actively listening and including them in their own care.

“Patients tend to define quality of care in terms of the quality of communication with members of their health care team,” Dr. Chou wrote.

Dr. Chou is a professor of medicine at the University of California, San Francisco. These comments were adapted from a commentary accompanying the report (Arch. Intl. Med. 2011;171:1585-6). He reported no relevant financial conflicts of interest.

Major Finding: Private health insurers pay an average of $3,996 for hip replacement surgery in the United States, compared with $2,160 in the United Kingdom, $1,943 in Australia, and $1,340 in France.

Data Source: Organization for Economic Cooperation and Development, Health Data 2010.

Disclosures: The study was funded in part by grants from the Robert Wood Johnson Foundation and the Commonwealth Fund. The authors had no financial conflicts to disclose.

Higher fees paid to physicians are a key reason for greater U.S. health care spending when compared with other nations, according to a new study.

There is also a greater pay differential between primary care and specialty care in the United States than in certain European countries, Australia, and Canada.

“Our findings as a whole suggest that the observed price differences are not entirely a consequence of differences in underlying practice costs or in the tuition costs of medical education,” said Miriam J. Laugesen of Columbia University and her Columbia colleague, Sherry A. Glied, who is currently on leave at the U.S. Department of Health and Human Services (HHS).

They offered several potential reasons for U.S. physicians' greater incomes. One possibility is that physicians are reflective of a certain strata of U.S. society: those who are more highly educated and skilled and tend to be more highly paid. But higher fees paid by private insurers in general, and for hip replacement surgery in particular, seem to be major contributors as well, they concluded (Health Aff. 2011;30:9 [doi: 10.1377/hlthaff.2010.0204]).

To examine whether higher prices in the United States are responsible for the greater level of health spending in this country, the researchers analyzed fees, incomes, and spending for primary care – defined as general and family practice, internal medicine, pediatrics, and ob.gyn. – and for orthopedic surgery, specifically, hip replacement.

Data on U.S. physicians and fees were compared with similar information for Australia, Canada, France, Germany, and the United Kingdom. All of these countries continue to use some kind of fee-for-service reimbursement, which allowed for closer comparisons.

Overall, physician income was highest in the United States. Primary care physicians earned about $186,000 before taxes and after practice expenses. Australian physicians earned the least, $92,000, while primary care physicians in the United Kingdom earned close to their U.S. counterparts at $159,000.

Using the fee paid for an 11- to 15-minute office visit for an established patient, the authors determined that public payers reimbursed only $34 in Australia.

The highest rate was in the United Kingdom, at $66. In the United States, physicians received an average of $60 per visit from public payers; Canadian physicians received about $59.

The authors calculated that U.S. primary care doctors earned about one-third more than their counterparts in the other nations, primarily because they receive a greater share of their reimbursement from private insurance than do primary care physicians in the other countries.

Of the physicians studied, U.S. orthopedic surgeons were the highest earners: $442,000 after expenses and before taxes. French surgeons earned the least at $154,000, while surgeons in the United Kingdom earned $324,000.

For orthopedic surgery, the public pay rate was lowest in Canada at $652 and highest in the United States at $1,634.

The authors found that private insurance for hip replacement in the United States paid about $4,000 per procedure – more than twice as much as the private rate in any of the other countries studied.

The research “really does a nice job of just very methodically walking through the steps to show that the physician fees and incomes are much higher in the U.S. and that that's at the heart of why we spend more on physician services,” Chapin White, a senior health researcher at the Center for Studying Health System Change, said in an interview.

It would be improper, however, to think that physician fees are solely to blame for higher health care spending in the United States, said Mr. White, noting that physician expenditures are a small slice of the health pie.

By detailing the difference between specialist and primary care pay in America, and the vast difference between payments for hip replacement surgery in the United States and other nations, the authors also showed a fundamental flaw in the payment system, he continued.

U.S. primary care doctors' income was only 42% of that earned by U.S. orthopedic surgeons. The authors speculated that this is because private insurers in the United States have been more successful in negotiating lower fees for primary care than for orthopedic surgery.

In Canada, France, and Germany, the pay gap was smaller: primary care physicians earned 60% of their surgery colleagues.

The pay gap between primary care and hip replacement surgery “is where the blinking red light is, that something is out of whack in the U.S.,” Mr. White said.

The research also shows that “it's not at all the case that primary care is underpaid, but more that the surgeons and specialists are overpaid,” he said.

Major Finding: Private health insurers pay an average of $3,996 for hip replacement surgery in the United States, compared with $2,160 in the United Kingdom, $1,943 in Australia, and $1,340 in France.

Data Source: Organization for Economic Cooperation and Development, Health Data 2010.

Disclosures: The study was funded in part by grants from the Robert Wood Johnson Foundation and the Commonwealth Fund. The authors had no financial conflicts to disclose.

Higher fees paid to physicians are a key reason for greater U.S. health care spending when compared with other nations, according to a new study.

There is also a greater pay differential between primary care and specialty care in the United States than in certain European countries, Australia, and Canada.

“Our findings as a whole suggest that the observed price differences are not entirely a consequence of differences in underlying practice costs or in the tuition costs of medical education,” said Miriam J. Laugesen of Columbia University and her Columbia colleague, Sherry A. Glied, who is currently on leave at the U.S. Department of Health and Human Services (HHS).

They offered several potential reasons for U.S. physicians' greater incomes. One possibility is that physicians are reflective of a certain strata of U.S. society: those who are more highly educated and skilled and tend to be more highly paid. But higher fees paid by private insurers in general, and for hip replacement surgery in particular, seem to be major contributors as well, they concluded (Health Aff. 2011;30:9 [doi: 10.1377/hlthaff.2010.0204]).

To examine whether higher prices in the United States are responsible for the greater level of health spending in this country, the researchers analyzed fees, incomes, and spending for primary care – defined as general and family practice, internal medicine, pediatrics, and ob.gyn. – and for orthopedic surgery, specifically, hip replacement.

Data on U.S. physicians and fees were compared with similar information for Australia, Canada, France, Germany, and the United Kingdom. All of these countries continue to use some kind of fee-for-service reimbursement, which allowed for closer comparisons.

Overall, physician income was highest in the United States. Primary care physicians earned about $186,000 before taxes and after practice expenses. Australian physicians earned the least, $92,000, while primary care physicians in the United Kingdom earned close to their U.S. counterparts at $159,000.

Using the fee paid for an 11- to 15-minute office visit for an established patient, the authors determined that public payers reimbursed only $34 in Australia.

The highest rate was in the United Kingdom, at $66. In the United States, physicians received an average of $60 per visit from public payers; Canadian physicians received about $59.

The authors calculated that U.S. primary care doctors earned about one-third more than their counterparts in the other nations, primarily because they receive a greater share of their reimbursement from private insurance than do primary care physicians in the other countries.

Of the physicians studied, U.S. orthopedic surgeons were the highest earners: $442,000 after expenses and before taxes. French surgeons earned the least at $154,000, while surgeons in the United Kingdom earned $324,000.

For orthopedic surgery, the public pay rate was lowest in Canada at $652 and highest in the United States at $1,634.

The authors found that private insurance for hip replacement in the United States paid about $4,000 per procedure – more than twice as much as the private rate in any of the other countries studied.

The research “really does a nice job of just very methodically walking through the steps to show that the physician fees and incomes are much higher in the U.S. and that that's at the heart of why we spend more on physician services,” Chapin White, a senior health researcher at the Center for Studying Health System Change, said in an interview.

It would be improper, however, to think that physician fees are solely to blame for higher health care spending in the United States, said Mr. White, noting that physician expenditures are a small slice of the health pie.

By detailing the difference between specialist and primary care pay in America, and the vast difference between payments for hip replacement surgery in the United States and other nations, the authors also showed a fundamental flaw in the payment system, he continued.

U.S. primary care doctors' income was only 42% of that earned by U.S. orthopedic surgeons. The authors speculated that this is because private insurers in the United States have been more successful in negotiating lower fees for primary care than for orthopedic surgery.

In Canada, France, and Germany, the pay gap was smaller: primary care physicians earned 60% of their surgery colleagues.

The pay gap between primary care and hip replacement surgery “is where the blinking red light is, that something is out of whack in the U.S.,” Mr. White said.

The research also shows that “it's not at all the case that primary care is underpaid, but more that the surgeons and specialists are overpaid,” he said.

Major Finding: Private health insurers pay an average of $3,996 for hip replacement surgery in the United States, compared with $2,160 in the United Kingdom, $1,943 in Australia, and $1,340 in France.

Data Source: Organization for Economic Cooperation and Development, Health Data 2010.

Disclosures: The study was funded in part by grants from the Robert Wood Johnson Foundation and the Commonwealth Fund. The authors had no financial conflicts to disclose.

Higher fees paid to physicians are a key reason for greater U.S. health care spending when compared with other nations, according to a new study.

There is also a greater pay differential between primary care and specialty care in the United States than in certain European countries, Australia, and Canada.

“Our findings as a whole suggest that the observed price differences are not entirely a consequence of differences in underlying practice costs or in the tuition costs of medical education,” said Miriam J. Laugesen of Columbia University and her Columbia colleague, Sherry A. Glied, who is currently on leave at the U.S. Department of Health and Human Services (HHS).

They offered several potential reasons for U.S. physicians' greater incomes. One possibility is that physicians are reflective of a certain strata of U.S. society: those who are more highly educated and skilled and tend to be more highly paid. But higher fees paid by private insurers in general, and for hip replacement surgery in particular, seem to be major contributors as well, they concluded (Health Aff. 2011;30:9 [doi: 10.1377/hlthaff.2010.0204]).

To examine whether higher prices in the United States are responsible for the greater level of health spending in this country, the researchers analyzed fees, incomes, and spending for primary care – defined as general and family practice, internal medicine, pediatrics, and ob.gyn. – and for orthopedic surgery, specifically, hip replacement.

Data on U.S. physicians and fees were compared with similar information for Australia, Canada, France, Germany, and the United Kingdom. All of these countries continue to use some kind of fee-for-service reimbursement, which allowed for closer comparisons.

Overall, physician income was highest in the United States. Primary care physicians earned about $186,000 before taxes and after practice expenses. Australian physicians earned the least, $92,000, while primary care physicians in the United Kingdom earned close to their U.S. counterparts at $159,000.

Using the fee paid for an 11- to 15-minute office visit for an established patient, the authors determined that public payers reimbursed only $34 in Australia.

The highest rate was in the United Kingdom, at $66. In the United States, physicians received an average of $60 per visit from public payers; Canadian physicians received about $59.

The authors calculated that U.S. primary care doctors earned about one-third more than their counterparts in the other nations, primarily because they receive a greater share of their reimbursement from private insurance than do primary care physicians in the other countries.

Of the physicians studied, U.S. orthopedic surgeons were the highest earners: $442,000 after expenses and before taxes. French surgeons earned the least at $154,000, while surgeons in the United Kingdom earned $324,000.

For orthopedic surgery, the public pay rate was lowest in Canada at $652 and highest in the United States at $1,634.

The authors found that private insurance for hip replacement in the United States paid about $4,000 per procedure – more than twice as much as the private rate in any of the other countries studied.

The research “really does a nice job of just very methodically walking through the steps to show that the physician fees and incomes are much higher in the U.S. and that that's at the heart of why we spend more on physician services,” Chapin White, a senior health researcher at the Center for Studying Health System Change, said in an interview.

It would be improper, however, to think that physician fees are solely to blame for higher health care spending in the United States, said Mr. White, noting that physician expenditures are a small slice of the health pie.

By detailing the difference between specialist and primary care pay in America, and the vast difference between payments for hip replacement surgery in the United States and other nations, the authors also showed a fundamental flaw in the payment system, he continued.

U.S. primary care doctors' income was only 42% of that earned by U.S. orthopedic surgeons. The authors speculated that this is because private insurers in the United States have been more successful in negotiating lower fees for primary care than for orthopedic surgery.

In Canada, France, and Germany, the pay gap was smaller: primary care physicians earned 60% of their surgery colleagues.

The pay gap between primary care and hip replacement surgery “is where the blinking red light is, that something is out of whack in the U.S.,” Mr. White said.

The research also shows that “it's not at all the case that primary care is underpaid, but more that the surgeons and specialists are overpaid,” he said.

EHR Incentive Participation Lags

Cardiologists are interested in participating in the federal government's incentive programs for electronic health records – but are not signing up in droves, according to a July membership survey conducted by the American College of Cardiology. About half the 152 respondents to the randomized survey said they were currently participating or planned to participate in the EHR Incentive Program and 34% said they had registered. So far, though, only 18% had met eligibility criteria to receive the payments and 12% of that group had actually gotten a payment. Most of the respondents said they wanted the incentive program to be simpler. The survey shows that, “We still have a long way to go to helping members qualify for 'meaningful use' and to achieve more general participation in the EHR incentive program,” Dr. Jack Lewin, the organization's CEO said in a statement. Full survey results will be published in the September/October issue of Cardiology Magazine.

Equal-Visitation Right Gets Boost

The Department of Health and Human Services has unveiled new guidance for protecting hospital patients' right to choose their own visitors, including same-sex domestic partners. The rule establishing that right was finalized last November, and the guidance – which applies to all patients at hospitals that take Medicare or Medicaid patients – is intended to help hospitals understand and follow the policy. Hospitals now must explain to all patients their right to choose who may visit them during a hospital stay, as well as their right to withdraw such consent to visitation at any time. The guidance also supports enforcement of the right of patients to designate the person of their choice to make medical decisions on their behalf should they become incapacitated. “It is unacceptable that, in the past, some same-sex partners were denied the right to visit their loved ones in times of need,” said HHS Secretary Kathleen Sebelius in a statement.

Heart Failure Deaths Drop 50%

The death rate for hospital patients admitted for heart failure fell by 50% between 2000 and 2007, the Agency for Healthcare Research and Quality announced. The rate dropped from 55 deaths per 1,000 admissions to 28 deaths per 1,000, according to data from the 2010 National Healthcare Disparities Report. The drop in deaths was greatest among people aged 85 years or older, declining from 87 per 1,000 to 48 per 1,000, but there was a decline in all age groups. For people age 65 or above, the rate dropped from 64 to 34 per 1,000. The death rate for the 45- to 64-year-old group declined from 28 to 15 per 1,000.

New Blood Pressure Genes

Twenty-nine genetic variations across 28 regions of the human genome that influence blood pressure recently were identified by an international research consortium, according to the National Heart, Lung, and Blood Institute. In a paper published in Nature Genetics the researchers found that the individual genetic variations increased the risk of hypertension by a very small amount, but that the risk was greatly increased when there were multiple variants. In all, 16 of the 29 variations were previously unrecognized and 6 were found in genes already suspected of having some effect on BP. The final 10 offered new clues on the regulation of BP. The 200,000 primary participants were of European extraction; that group also included participants in the Framingham Heart Study. The consortium conducted a follow-up analysis on 70,000 people of East Asian, South Asian, and African ancestry and found similar risks with the variants.

Companies Hit as Antigeneric

Brand-name drug manufacturers have been actively discouraging generic drugs, the Federal Trade Commission said in a long-awaited report on the generic drug market. Brand-name makers often introduce their own generic versions of their products to discourage generic-focused companies from entering the market when a patent runs out, the FTC said. The presence of an authorized generic tends to tamp down sales 40%-50% for a generic competitor, according to the report. “Some brand companies may be using the threat of launching an authorized generic as a powerful inducement for generic companies to delay bringing their drugs to market,” FTC Chairman Jon Leibowitz said in a statement, adding that during such a delay, consumers must continue to pay for the brand-name drug. The report “proves what I have long suspected: that promotion of authorized generics can reduce the incentive for true generic companies to enter the market. That allows brand name companies to unfairly dominate the marketplace long after their patents have expired,” Sen. Jay Rockefeller (D-W.Va.) said in a statement.

Safety System Pilot Online

The FDA announced that it has launched a pilot of what it hopes eventually will be a major rapid-response electronic safety-surveillance system. The “Mini-Sentinel” is the pilot run but is no small effort, according to the agency. It includes 17 data partners and covers 99 million people, 2.4 billion medical encounters, and the dispensing of 2.9 billion prescriptions. The database should allow researchers to get answers to drug-safety questions within weeks, not months. Initial data on the Mini-Sentinel program was presented at the International Conference on Pharmacoepidemiology and Therapeutic Risk Management in mid-August.

EHR Incentive Participation Lags

Cardiologists are interested in participating in the federal government's incentive programs for electronic health records – but are not signing up in droves, according to a July membership survey conducted by the American College of Cardiology. About half the 152 respondents to the randomized survey said they were currently participating or planned to participate in the EHR Incentive Program and 34% said they had registered. So far, though, only 18% had met eligibility criteria to receive the payments and 12% of that group had actually gotten a payment. Most of the respondents said they wanted the incentive program to be simpler. The survey shows that, “We still have a long way to go to helping members qualify for 'meaningful use' and to achieve more general participation in the EHR incentive program,” Dr. Jack Lewin, the organization's CEO said in a statement. Full survey results will be published in the September/October issue of Cardiology Magazine.

Equal-Visitation Right Gets Boost

The Department of Health and Human Services has unveiled new guidance for protecting hospital patients' right to choose their own visitors, including same-sex domestic partners. The rule establishing that right was finalized last November, and the guidance – which applies to all patients at hospitals that take Medicare or Medicaid patients – is intended to help hospitals understand and follow the policy. Hospitals now must explain to all patients their right to choose who may visit them during a hospital stay, as well as their right to withdraw such consent to visitation at any time. The guidance also supports enforcement of the right of patients to designate the person of their choice to make medical decisions on their behalf should they become incapacitated. “It is unacceptable that, in the past, some same-sex partners were denied the right to visit their loved ones in times of need,” said HHS Secretary Kathleen Sebelius in a statement.

Heart Failure Deaths Drop 50%

The death rate for hospital patients admitted for heart failure fell by 50% between 2000 and 2007, the Agency for Healthcare Research and Quality announced. The rate dropped from 55 deaths per 1,000 admissions to 28 deaths per 1,000, according to data from the 2010 National Healthcare Disparities Report. The drop in deaths was greatest among people aged 85 years or older, declining from 87 per 1,000 to 48 per 1,000, but there was a decline in all age groups. For people age 65 or above, the rate dropped from 64 to 34 per 1,000. The death rate for the 45- to 64-year-old group declined from 28 to 15 per 1,000.

New Blood Pressure Genes

Twenty-nine genetic variations across 28 regions of the human genome that influence blood pressure recently were identified by an international research consortium, according to the National Heart, Lung, and Blood Institute. In a paper published in Nature Genetics the researchers found that the individual genetic variations increased the risk of hypertension by a very small amount, but that the risk was greatly increased when there were multiple variants. In all, 16 of the 29 variations were previously unrecognized and 6 were found in genes already suspected of having some effect on BP. The final 10 offered new clues on the regulation of BP. The 200,000 primary participants were of European extraction; that group also included participants in the Framingham Heart Study. The consortium conducted a follow-up analysis on 70,000 people of East Asian, South Asian, and African ancestry and found similar risks with the variants.

Companies Hit as Antigeneric

Brand-name drug manufacturers have been actively discouraging generic drugs, the Federal Trade Commission said in a long-awaited report on the generic drug market. Brand-name makers often introduce their own generic versions of their products to discourage generic-focused companies from entering the market when a patent runs out, the FTC said. The presence of an authorized generic tends to tamp down sales 40%-50% for a generic competitor, according to the report. “Some brand companies may be using the threat of launching an authorized generic as a powerful inducement for generic companies to delay bringing their drugs to market,” FTC Chairman Jon Leibowitz said in a statement, adding that during such a delay, consumers must continue to pay for the brand-name drug. The report “proves what I have long suspected: that promotion of authorized generics can reduce the incentive for true generic companies to enter the market. That allows brand name companies to unfairly dominate the marketplace long after their patents have expired,” Sen. Jay Rockefeller (D-W.Va.) said in a statement.

Safety System Pilot Online

The FDA announced that it has launched a pilot of what it hopes eventually will be a major rapid-response electronic safety-surveillance system. The “Mini-Sentinel” is the pilot run but is no small effort, according to the agency. It includes 17 data partners and covers 99 million people, 2.4 billion medical encounters, and the dispensing of 2.9 billion prescriptions. The database should allow researchers to get answers to drug-safety questions within weeks, not months. Initial data on the Mini-Sentinel program was presented at the International Conference on Pharmacoepidemiology and Therapeutic Risk Management in mid-August.

EHR Incentive Participation Lags

Cardiologists are interested in participating in the federal government's incentive programs for electronic health records – but are not signing up in droves, according to a July membership survey conducted by the American College of Cardiology. About half the 152 respondents to the randomized survey said they were currently participating or planned to participate in the EHR Incentive Program and 34% said they had registered. So far, though, only 18% had met eligibility criteria to receive the payments and 12% of that group had actually gotten a payment. Most of the respondents said they wanted the incentive program to be simpler. The survey shows that, “We still have a long way to go to helping members qualify for 'meaningful use' and to achieve more general participation in the EHR incentive program,” Dr. Jack Lewin, the organization's CEO said in a statement. Full survey results will be published in the September/October issue of Cardiology Magazine.

Equal-Visitation Right Gets Boost

The Department of Health and Human Services has unveiled new guidance for protecting hospital patients' right to choose their own visitors, including same-sex domestic partners. The rule establishing that right was finalized last November, and the guidance – which applies to all patients at hospitals that take Medicare or Medicaid patients – is intended to help hospitals understand and follow the policy. Hospitals now must explain to all patients their right to choose who may visit them during a hospital stay, as well as their right to withdraw such consent to visitation at any time. The guidance also supports enforcement of the right of patients to designate the person of their choice to make medical decisions on their behalf should they become incapacitated. “It is unacceptable that, in the past, some same-sex partners were denied the right to visit their loved ones in times of need,” said HHS Secretary Kathleen Sebelius in a statement.

Heart Failure Deaths Drop 50%

The death rate for hospital patients admitted for heart failure fell by 50% between 2000 and 2007, the Agency for Healthcare Research and Quality announced. The rate dropped from 55 deaths per 1,000 admissions to 28 deaths per 1,000, according to data from the 2010 National Healthcare Disparities Report. The drop in deaths was greatest among people aged 85 years or older, declining from 87 per 1,000 to 48 per 1,000, but there was a decline in all age groups. For people age 65 or above, the rate dropped from 64 to 34 per 1,000. The death rate for the 45- to 64-year-old group declined from 28 to 15 per 1,000.

New Blood Pressure Genes

Twenty-nine genetic variations across 28 regions of the human genome that influence blood pressure recently were identified by an international research consortium, according to the National Heart, Lung, and Blood Institute. In a paper published in Nature Genetics the researchers found that the individual genetic variations increased the risk of hypertension by a very small amount, but that the risk was greatly increased when there were multiple variants. In all, 16 of the 29 variations were previously unrecognized and 6 were found in genes already suspected of having some effect on BP. The final 10 offered new clues on the regulation of BP. The 200,000 primary participants were of European extraction; that group also included participants in the Framingham Heart Study. The consortium conducted a follow-up analysis on 70,000 people of East Asian, South Asian, and African ancestry and found similar risks with the variants.

Companies Hit as Antigeneric

Brand-name drug manufacturers have been actively discouraging generic drugs, the Federal Trade Commission said in a long-awaited report on the generic drug market. Brand-name makers often introduce their own generic versions of their products to discourage generic-focused companies from entering the market when a patent runs out, the FTC said. The presence of an authorized generic tends to tamp down sales 40%-50% for a generic competitor, according to the report. “Some brand companies may be using the threat of launching an authorized generic as a powerful inducement for generic companies to delay bringing their drugs to market,” FTC Chairman Jon Leibowitz said in a statement, adding that during such a delay, consumers must continue to pay for the brand-name drug. The report “proves what I have long suspected: that promotion of authorized generics can reduce the incentive for true generic companies to enter the market. That allows brand name companies to unfairly dominate the marketplace long after their patents have expired,” Sen. Jay Rockefeller (D-W.Va.) said in a statement.

Safety System Pilot Online

The FDA announced that it has launched a pilot of what it hopes eventually will be a major rapid-response electronic safety-surveillance system. The “Mini-Sentinel” is the pilot run but is no small effort, according to the agency. It includes 17 data partners and covers 99 million people, 2.4 billion medical encounters, and the dispensing of 2.9 billion prescriptions. The database should allow researchers to get answers to drug-safety questions within weeks, not months. Initial data on the Mini-Sentinel program was presented at the International Conference on Pharmacoepidemiology and Therapeutic Risk Management in mid-August.

The Joint Commission issued a list of what it is designating as the top-performing hospitals in America, and the facilities that are not listed may be somewhat surprising.

The Commission, which accredits some 4,000 hospitals in the United States, created a new designation for hospitals last year, to recognize the ones that are “the best of the best” in terms of quality, said Dr. Mark R. Chassin, president of the Joint Commission.

Out of the 3,000 hospitals for which the Joint Commission has been collecting performance data on for the last decade, 405 met the top performance criteria for data reported in 2010. They represent only 14% of the universe of facilities that the Joint Commission accredits.

These hospitals had a 95% score on a composite measure for all 22 performance measures for heart attack, heart failure, pneumonia, surgical care, and children's asthma care. The hospitals also met a second 95% target for each individual measure, which means “a hospital provided an evidence-based practice 95 times out of 100 opportunities to provide the practice,” according to the Joint Commission.

The 405 that made the cut were primarily small and rural, leading to questions from reporters as to why some of the bigger and better-known academic and urban medical centers, all having stellar reputations, did not achieve the ranking of a top performer. Dr. Chassin replied, “Reputation and performance on important measures of quality don't often go together.”

Missing from the list are such well-known facilities as Johns Hopkins, Duke, the Cleveland Clinic, the Mayo Clinic, M.D. Anderson, and even the Geisinger Health System, which has been hailed as a quality pioneer.

Dr. Chassin said that the Commission's use of process measures, instead of outcomes measures, was the best way to determine quality of care.

Overall, hospitals are doing much better at meeting these measures, said Dr. Chassin. But he added, “Hospitals can and should do better.”

Among the improvements tallied by the Joint Commission in its annual report on quality:

▋ Hospitals provided an evidence-based heart attack treatment 984 times for every 1,000 opportunities to do so, for a composite score of 98.4%. That's up from 86.9% in 2002.

▋ The surgical care score improved from 82.1% in 2005 (when it was added) to 96.4%.

▋ A total of 91.7% of hospitals achieved 90% or better on the overall composite score, up from just 26.2% in 2002.

Hospitals are still lagging in two areas. Only 60% are hitting the 90% target for providing fibrinolytic therapy for acute MI within a half hour of arrival. And 77% are reaching the 90% compliance goal for administering antibiotics to ICU pneumonia patients who are immunocompetent.

Starting in 2012, hospitals seeking accreditation will be required to hit 85% or better on a new composite measurement for performance on accountability measures. Dr. Chassin estimated that currently, 121 hospitals would not hit that target.

View on the News

Quality's in Outcomes, Not Process

Given that the “quality” we are talking about here is measured by process documentation (not actual outcomes), the smaller the hospital and number of documenting physicians, the more likely you are to see percentages of “quality” in the upper echelons. In other words, the process may be occurring in the larger hospitals, it is just not getting documented as such. … Smaller hospitals can create uniform documentation standards a lot faster than larger hospitals.

It is a bit disingenuous for Dr. Chassin to suggest that reputation and performance do not often go together. In the case of the Cleveland Clinic, Johns Hopkins, Duke, and other similar centers, it most certainly does and has been shown in direct outcomes measurement.

You will notice that Lakewood Hospital in Lakewood, Ohio, is the only Cleveland-area hospital that is in the upper echelon in process measurement for acute MI as listed by the Joint Commission (as it is, Lakewood Hospital is owned by the Cleveland Clinic and is a member of the Cleveland Clinic Health System), but if, because of this “best of the best” list, a complicated patient with an acute MI chooses to go to Lakewood Hospital over going to a tertiary center with outcomes reported as good as the Cleveland Clinic main campus, then the Joint Commission should be ashamed of itself.

FRANKLIN A. MICHOTA, M.D., is director of academic affairs in the department of hospital medicine at the Cleveland Clinic.

The Joint Commission issued a list of what it is designating as the top-performing hospitals in America, and the facilities that are not listed may be somewhat surprising.

The Commission, which accredits some 4,000 hospitals in the United States, created a new designation for hospitals last year, to recognize the ones that are “the best of the best” in terms of quality, said Dr. Mark R. Chassin, president of the Joint Commission.

Out of the 3,000 hospitals for which the Joint Commission has been collecting performance data on for the last decade, 405 met the top performance criteria for data reported in 2010. They represent only 14% of the universe of facilities that the Joint Commission accredits.

These hospitals had a 95% score on a composite measure for all 22 performance measures for heart attack, heart failure, pneumonia, surgical care, and children's asthma care. The hospitals also met a second 95% target for each individual measure, which means “a hospital provided an evidence-based practice 95 times out of 100 opportunities to provide the practice,” according to the Joint Commission.

The 405 that made the cut were primarily small and rural, leading to questions from reporters as to why some of the bigger and better-known academic and urban medical centers, all having stellar reputations, did not achieve the ranking of a top performer. Dr. Chassin replied, “Reputation and performance on important measures of quality don't often go together.”

Missing from the list are such well-known facilities as Johns Hopkins, Duke, the Cleveland Clinic, the Mayo Clinic, M.D. Anderson, and even the Geisinger Health System, which has been hailed as a quality pioneer.

Dr. Chassin said that the Commission's use of process measures, instead of outcomes measures, was the best way to determine quality of care.

Overall, hospitals are doing much better at meeting these measures, said Dr. Chassin. But he added, “Hospitals can and should do better.”

Among the improvements tallied by the Joint Commission in its annual report on quality:

▋ Hospitals provided an evidence-based heart attack treatment 984 times for every 1,000 opportunities to do so, for a composite score of 98.4%. That's up from 86.9% in 2002.

▋ The surgical care score improved from 82.1% in 2005 (when it was added) to 96.4%.

▋ A total of 91.7% of hospitals achieved 90% or better on the overall composite score, up from just 26.2% in 2002.

Hospitals are still lagging in two areas. Only 60% are hitting the 90% target for providing fibrinolytic therapy for acute MI within a half hour of arrival. And 77% are reaching the 90% compliance goal for administering antibiotics to ICU pneumonia patients who are immunocompetent.

Starting in 2012, hospitals seeking accreditation will be required to hit 85% or better on a new composite measurement for performance on accountability measures. Dr. Chassin estimated that currently, 121 hospitals would not hit that target.

View on the News

Quality's in Outcomes, Not Process

Given that the “quality” we are talking about here is measured by process documentation (not actual outcomes), the smaller the hospital and number of documenting physicians, the more likely you are to see percentages of “quality” in the upper echelons. In other words, the process may be occurring in the larger hospitals, it is just not getting documented as such. … Smaller hospitals can create uniform documentation standards a lot faster than larger hospitals.

It is a bit disingenuous for Dr. Chassin to suggest that reputation and performance do not often go together. In the case of the Cleveland Clinic, Johns Hopkins, Duke, and other similar centers, it most certainly does and has been shown in direct outcomes measurement.

You will notice that Lakewood Hospital in Lakewood, Ohio, is the only Cleveland-area hospital that is in the upper echelon in process measurement for acute MI as listed by the Joint Commission (as it is, Lakewood Hospital is owned by the Cleveland Clinic and is a member of the Cleveland Clinic Health System), but if, because of this “best of the best” list, a complicated patient with an acute MI chooses to go to Lakewood Hospital over going to a tertiary center with outcomes reported as good as the Cleveland Clinic main campus, then the Joint Commission should be ashamed of itself.

FRANKLIN A. MICHOTA, M.D., is director of academic affairs in the department of hospital medicine at the Cleveland Clinic.

The Joint Commission issued a list of what it is designating as the top-performing hospitals in America, and the facilities that are not listed may be somewhat surprising.

The Commission, which accredits some 4,000 hospitals in the United States, created a new designation for hospitals last year, to recognize the ones that are “the best of the best” in terms of quality, said Dr. Mark R. Chassin, president of the Joint Commission.

Out of the 3,000 hospitals for which the Joint Commission has been collecting performance data on for the last decade, 405 met the top performance criteria for data reported in 2010. They represent only 14% of the universe of facilities that the Joint Commission accredits.

These hospitals had a 95% score on a composite measure for all 22 performance measures for heart attack, heart failure, pneumonia, surgical care, and children's asthma care. The hospitals also met a second 95% target for each individual measure, which means “a hospital provided an evidence-based practice 95 times out of 100 opportunities to provide the practice,” according to the Joint Commission.

The 405 that made the cut were primarily small and rural, leading to questions from reporters as to why some of the bigger and better-known academic and urban medical centers, all having stellar reputations, did not achieve the ranking of a top performer. Dr. Chassin replied, “Reputation and performance on important measures of quality don't often go together.”

Missing from the list are such well-known facilities as Johns Hopkins, Duke, the Cleveland Clinic, the Mayo Clinic, M.D. Anderson, and even the Geisinger Health System, which has been hailed as a quality pioneer.

Dr. Chassin said that the Commission's use of process measures, instead of outcomes measures, was the best way to determine quality of care.

Overall, hospitals are doing much better at meeting these measures, said Dr. Chassin. But he added, “Hospitals can and should do better.”

Among the improvements tallied by the Joint Commission in its annual report on quality:

▋ Hospitals provided an evidence-based heart attack treatment 984 times for every 1,000 opportunities to do so, for a composite score of 98.4%. That's up from 86.9% in 2002.

▋ The surgical care score improved from 82.1% in 2005 (when it was added) to 96.4%.

▋ A total of 91.7% of hospitals achieved 90% or better on the overall composite score, up from just 26.2% in 2002.

Hospitals are still lagging in two areas. Only 60% are hitting the 90% target for providing fibrinolytic therapy for acute MI within a half hour of arrival. And 77% are reaching the 90% compliance goal for administering antibiotics to ICU pneumonia patients who are immunocompetent.

Starting in 2012, hospitals seeking accreditation will be required to hit 85% or better on a new composite measurement for performance on accountability measures. Dr. Chassin estimated that currently, 121 hospitals would not hit that target.

View on the News

Quality's in Outcomes, Not Process

Given that the “quality” we are talking about here is measured by process documentation (not actual outcomes), the smaller the hospital and number of documenting physicians, the more likely you are to see percentages of “quality” in the upper echelons. In other words, the process may be occurring in the larger hospitals, it is just not getting documented as such. … Smaller hospitals can create uniform documentation standards a lot faster than larger hospitals.

It is a bit disingenuous for Dr. Chassin to suggest that reputation and performance do not often go together. In the case of the Cleveland Clinic, Johns Hopkins, Duke, and other similar centers, it most certainly does and has been shown in direct outcomes measurement.

You will notice that Lakewood Hospital in Lakewood, Ohio, is the only Cleveland-area hospital that is in the upper echelon in process measurement for acute MI as listed by the Joint Commission (as it is, Lakewood Hospital is owned by the Cleveland Clinic and is a member of the Cleveland Clinic Health System), but if, because of this “best of the best” list, a complicated patient with an acute MI chooses to go to Lakewood Hospital over going to a tertiary center with outcomes reported as good as the Cleveland Clinic main campus, then the Joint Commission should be ashamed of itself.

FRANKLIN A. MICHOTA, M.D., is director of academic affairs in the department of hospital medicine at the Cleveland Clinic.

Medicare will begin rewarding primary care physicians for spending more time with patients and offering services such as late hours and intensive care management beginning next summer, under a new program unveiled Sept. 28.

The Comprehensive Primary Care Initiative aims to pay primary care physicians for services that they currently might not have time to provide or aren’t getting paid for – such as creating a care plan, reviewing test results on the phone, or helping patients closely manage cholesterol or weight, Dr. Richard Baron, director of the seamless care models group at the Centers for Medicare and Medicaid Services (CMS), said during a telephone briefing with reporters.

Some physician groups welcomed the announcement. The initiative "offers enormous potential to promote the kind of personalized and coordinated care that patients seek and that physicians want to deliver," Dr. Steven Weinberger, executive vice president and chief executive officer of the American College of Physicians, said in a statement. The program "will provide primary care physicians with the support needed to work hand-in-hand with patients toward a shared goal of ensuring high-quality care while making the most efficient use of health care resources."

The initiative is being funded by the Affordable Care Act, and is part of the plan to overhaul how health care is delivered and reimbursed, Dr. Baron said.

"Instead of being paid for doing more procedures and squeezing more patients into each day, primary care practices will receive payments for being accessible after hours or using electronic health records to make sure care is well coordinated," Health and Human Services Secretary Kathleen Sebelius said during the briefing. "For patients, it means valuable extra time with their doctors, to understand their conditions and talk about how to lead healthier lives."

The program aims to recognize the ability of primary care to lower costs and improve health outcomes, Dr. Baron said. Some insurers and self-insured companies have started making similar payments for enhanced primary care services.

Dick Wilkerson, chairman and president of Michelin North America, said that his company has seen a huge decrease in health costs by covering 100% of preventive care services and 100% of care for people with chronic conditions, as well as making primary care services available on-site at two of its major facilities. Primary care physicians are required to spend a minimum of 20 minutes with each Michelin patient, he said.

The company has had a big reduction in emergency department visits, hospitalizations, and high-cost claims, he said.

WellPoint has also been testing bonus payments and coordinated care models in nine of its Blue Cross Blue Shield plans, said Dr. Sam Nussbaum, WellPoint chief medical officer. Participating medical practices offer on-site care managers and 24/7 access for members. There has been a 4%-6% reduction in hospitalizations, rehospitalizations, and emergency department visits, he said.

Medicare is hoping to build on examples like this by enticing more companies and payers – including employer-sponsored plans and state health plans – to join the Primary Care Initiative, Dr. Baron said.

Medicare’s efforts may also make it easier for physicians, Dr. Baron said, noting that many were reluctant to change the way they practice for a single insurer that might account for a small percentage of their patients.

ACP’s Dr. Weinberger said that bringing other payers on board was key. "Aligning support from multiple payers will provide a more realistic evaluation of these innovative payment and delivery reforms than earlier, more limited efforts," he said.

The agency is seeking letters of intent from private insurers and other payers by Nov. 15; final applications are due by Jan. 17. After the CMS has identified the markets where there will be a critical mass of Medicare and private pay patients covered by the incentives, the agency will solicit participation from primary care physicians.

The aim is to be in five to seven markets with 75 physician practices participating.

Physicians who meet the program goals will be eligible to receive $20 per Medicare beneficiary per month for the first 2 years of the program. The payment will be reduced to $15 for the second 2 years.

It will be up to the practices to determine how they can best manage patients for that incentive, said Dr. Richard Gilfillan, acting director of the CMS Innovation Center. But, he and Dr. Baron noted that the CMS will be available to help physician practices with data and other support to make the initiative work for them.

Medicare will begin rewarding primary care physicians for spending more time with patients and offering services such as late hours and intensive care management beginning next summer, under a new program unveiled Sept. 28.

The Comprehensive Primary Care Initiative aims to pay primary care physicians for services that they currently might not have time to provide or aren’t getting paid for – such as creating a care plan, reviewing test results on the phone, or helping patients closely manage cholesterol or weight, Dr. Richard Baron, director of the seamless care models group at the Centers for Medicare and Medicaid Services (CMS), said during a telephone briefing with reporters.

Some physician groups welcomed the announcement. The initiative "offers enormous potential to promote the kind of personalized and coordinated care that patients seek and that physicians want to deliver," Dr. Steven Weinberger, executive vice president and chief executive officer of the American College of Physicians, said in a statement. The program "will provide primary care physicians with the support needed to work hand-in-hand with patients toward a shared goal of ensuring high-quality care while making the most efficient use of health care resources."

The initiative is being funded by the Affordable Care Act, and is part of the plan to overhaul how health care is delivered and reimbursed, Dr. Baron said.

"Instead of being paid for doing more procedures and squeezing more patients into each day, primary care practices will receive payments for being accessible after hours or using electronic health records to make sure care is well coordinated," Health and Human Services Secretary Kathleen Sebelius said during the briefing. "For patients, it means valuable extra time with their doctors, to understand their conditions and talk about how to lead healthier lives."

The program aims to recognize the ability of primary care to lower costs and improve health outcomes, Dr. Baron said. Some insurers and self-insured companies have started making similar payments for enhanced primary care services.

Dick Wilkerson, chairman and president of Michelin North America, said that his company has seen a huge decrease in health costs by covering 100% of preventive care services and 100% of care for people with chronic conditions, as well as making primary care services available on-site at two of its major facilities. Primary care physicians are required to spend a minimum of 20 minutes with each Michelin patient, he said.

The company has had a big reduction in emergency department visits, hospitalizations, and high-cost claims, he said.

WellPoint has also been testing bonus payments and coordinated care models in nine of its Blue Cross Blue Shield plans, said Dr. Sam Nussbaum, WellPoint chief medical officer. Participating medical practices offer on-site care managers and 24/7 access for members. There has been a 4%-6% reduction in hospitalizations, rehospitalizations, and emergency department visits, he said.

Medicare is hoping to build on examples like this by enticing more companies and payers – including employer-sponsored plans and state health plans – to join the Primary Care Initiative, Dr. Baron said.

Medicare’s efforts may also make it easier for physicians, Dr. Baron said, noting that many were reluctant to change the way they practice for a single insurer that might account for a small percentage of their patients.

ACP’s Dr. Weinberger said that bringing other payers on board was key. "Aligning support from multiple payers will provide a more realistic evaluation of these innovative payment and delivery reforms than earlier, more limited efforts," he said.

The agency is seeking letters of intent from private insurers and other payers by Nov. 15; final applications are due by Jan. 17. After the CMS has identified the markets where there will be a critical mass of Medicare and private pay patients covered by the incentives, the agency will solicit participation from primary care physicians.

The aim is to be in five to seven markets with 75 physician practices participating.

Physicians who meet the program goals will be eligible to receive $20 per Medicare beneficiary per month for the first 2 years of the program. The payment will be reduced to $15 for the second 2 years.

It will be up to the practices to determine how they can best manage patients for that incentive, said Dr. Richard Gilfillan, acting director of the CMS Innovation Center. But, he and Dr. Baron noted that the CMS will be available to help physician practices with data and other support to make the initiative work for them.

Medicare will begin rewarding primary care physicians for spending more time with patients and offering services such as late hours and intensive care management beginning next summer, under a new program unveiled Sept. 28.

The Comprehensive Primary Care Initiative aims to pay primary care physicians for services that they currently might not have time to provide or aren’t getting paid for – such as creating a care plan, reviewing test results on the phone, or helping patients closely manage cholesterol or weight, Dr. Richard Baron, director of the seamless care models group at the Centers for Medicare and Medicaid Services (CMS), said during a telephone briefing with reporters.

Some physician groups welcomed the announcement. The initiative "offers enormous potential to promote the kind of personalized and coordinated care that patients seek and that physicians want to deliver," Dr. Steven Weinberger, executive vice president and chief executive officer of the American College of Physicians, said in a statement. The program "will provide primary care physicians with the support needed to work hand-in-hand with patients toward a shared goal of ensuring high-quality care while making the most efficient use of health care resources."

The initiative is being funded by the Affordable Care Act, and is part of the plan to overhaul how health care is delivered and reimbursed, Dr. Baron said.

"Instead of being paid for doing more procedures and squeezing more patients into each day, primary care practices will receive payments for being accessible after hours or using electronic health records to make sure care is well coordinated," Health and Human Services Secretary Kathleen Sebelius said during the briefing. "For patients, it means valuable extra time with their doctors, to understand their conditions and talk about how to lead healthier lives."

The program aims to recognize the ability of primary care to lower costs and improve health outcomes, Dr. Baron said. Some insurers and self-insured companies have started making similar payments for enhanced primary care services.

Dick Wilkerson, chairman and president of Michelin North America, said that his company has seen a huge decrease in health costs by covering 100% of preventive care services and 100% of care for people with chronic conditions, as well as making primary care services available on-site at two of its major facilities. Primary care physicians are required to spend a minimum of 20 minutes with each Michelin patient, he said.

The company has had a big reduction in emergency department visits, hospitalizations, and high-cost claims, he said.

WellPoint has also been testing bonus payments and coordinated care models in nine of its Blue Cross Blue Shield plans, said Dr. Sam Nussbaum, WellPoint chief medical officer. Participating medical practices offer on-site care managers and 24/7 access for members. There has been a 4%-6% reduction in hospitalizations, rehospitalizations, and emergency department visits, he said.

Medicare is hoping to build on examples like this by enticing more companies and payers – including employer-sponsored plans and state health plans – to join the Primary Care Initiative, Dr. Baron said.

Medicare’s efforts may also make it easier for physicians, Dr. Baron said, noting that many were reluctant to change the way they practice for a single insurer that might account for a small percentage of their patients.

ACP’s Dr. Weinberger said that bringing other payers on board was key. "Aligning support from multiple payers will provide a more realistic evaluation of these innovative payment and delivery reforms than earlier, more limited efforts," he said.

The agency is seeking letters of intent from private insurers and other payers by Nov. 15; final applications are due by Jan. 17. After the CMS has identified the markets where there will be a critical mass of Medicare and private pay patients covered by the incentives, the agency will solicit participation from primary care physicians.

The aim is to be in five to seven markets with 75 physician practices participating.

Physicians who meet the program goals will be eligible to receive $20 per Medicare beneficiary per month for the first 2 years of the program. The payment will be reduced to $15 for the second 2 years.

It will be up to the practices to determine how they can best manage patients for that incentive, said Dr. Richard Gilfillan, acting director of the CMS Innovation Center. But, he and Dr. Baron noted that the CMS will be available to help physician practices with data and other support to make the initiative work for them.

The Food and Drug Administration has deemed MelaFind, a noninvasive melanoma detection device, approvable, according to the manufacturer.

The FDA still has a list of requirements the manufacturer, Mela Sciences, must fulfill before MelaFind is given final approval. But company CEO, Joseph V. Gulfo, M.D., said in a conference call with analysts that much of the work is already done and that he expects no significant delays to market.

Photo courtesy Mela Sciences

The road to approval has been somewhat rocky. In November 2010, an FDA advisory panel split 8-7, with one abstention over whether MelaFind should be approved.

Then in May 2011, the company submitted a Citizen Petition to the FDA seeking action on its application for approval.

The company will have to work with the FDA on physician and patient labeling, a package insert and user’s guide, a training program for dermatologists, and the protocol for a postmarketing study.

Dr. Gulfo said that he expects MelaFind to be commercially available in the spring of 2012. Initially, it will only be sold to a handful of dermatologists in Connecticut, New Jersey, and New York. Mela Sciences will be working with dermatologists to fine tune the device before rolling it out to a larger number of practices, he said.

MelaFind is a multispectral computer vision system with a handheld imager that captures the image of a lesion; software uses algorithms to analyze the image, indicating within 2 minutes whether a biopsy should be done.

At the FDA panel meeting in November, some advisers expressed concern that MelaFind might be used by nondermatologists or that it would be used in place of clinical evaluation.

Mela Sciences and the FDA worked on clarifying the indications for use. Those indications now cover multiple paragraphs. According to a Mela Sciences press release, the device "is intended for use on clinically atypical cutaneous pigmented lesions with one or more clinical or historical characteristics of melanoma, excluding those with a clinical diagnosis of melanoma or likely melanoma."

Photo courtesy Mela Sciences

Labeling will also state that the device is "only for use by physicians trained in the clinical diagnosis and management of skin cancer (i.e., dermatologists) who have also successfully completed a training program in the appropriate use of MelaFind."

Dr. Darrell S. Rigel, a consultant for Mela Sciences, said in the company statement that the device can help dermatologists decide which lesions to biopsy and will be an aid to clinical evaluation. "While there have been incremental improvements in imaging tools for melanoma detection, we still primarily rely on our judgment based on a visual examination to select the lesions to biopsy; data show that this is often not enough," said Dr. Rigel, a clinical professor of dermatology at New York University.

The pivotal study of the device included 1,383 patients. According to the company, MelaFind had a sensitivity of 98%. The device’s sensitivity rating for malignant melanoma was significantly better than that of dermatologists, who showed a wide range of variability about which lesions would have been recommended for biopsy and which relegated to observation.

MelaFind will also soon be available in Germany, which has some of the highest rates of melanoma in Europe, said Dr. Gulfo. The device received European Union approval in September. The company aims to have about 75 systems in Germany by next September, Dr. Gulfo said.

The Food and Drug Administration has deemed MelaFind, a noninvasive melanoma detection device, approvable, according to the manufacturer.

The FDA still has a list of requirements the manufacturer, Mela Sciences, must fulfill before MelaFind is given final approval. But company CEO, Joseph V. Gulfo, M.D., said in a conference call with analysts that much of the work is already done and that he expects no significant delays to market.

Photo courtesy Mela Sciences

The road to approval has been somewhat rocky. In November 2010, an FDA advisory panel split 8-7, with one abstention over whether MelaFind should be approved.

Then in May 2011, the company submitted a Citizen Petition to the FDA seeking action on its application for approval.

The company will have to work with the FDA on physician and patient labeling, a package insert and user’s guide, a training program for dermatologists, and the protocol for a postmarketing study.

Dr. Gulfo said that he expects MelaFind to be commercially available in the spring of 2012. Initially, it will only be sold to a handful of dermatologists in Connecticut, New Jersey, and New York. Mela Sciences will be working with dermatologists to fine tune the device before rolling it out to a larger number of practices, he said.

MelaFind is a multispectral computer vision system with a handheld imager that captures the image of a lesion; software uses algorithms to analyze the image, indicating within 2 minutes whether a biopsy should be done.

At the FDA panel meeting in November, some advisers expressed concern that MelaFind might be used by nondermatologists or that it would be used in place of clinical evaluation.

Mela Sciences and the FDA worked on clarifying the indications for use. Those indications now cover multiple paragraphs. According to a Mela Sciences press release, the device "is intended for use on clinically atypical cutaneous pigmented lesions with one or more clinical or historical characteristics of melanoma, excluding those with a clinical diagnosis of melanoma or likely melanoma."

Photo courtesy Mela Sciences

Labeling will also state that the device is "only for use by physicians trained in the clinical diagnosis and management of skin cancer (i.e., dermatologists) who have also successfully completed a training program in the appropriate use of MelaFind."

Dr. Darrell S. Rigel, a consultant for Mela Sciences, said in the company statement that the device can help dermatologists decide which lesions to biopsy and will be an aid to clinical evaluation. "While there have been incremental improvements in imaging tools for melanoma detection, we still primarily rely on our judgment based on a visual examination to select the lesions to biopsy; data show that this is often not enough," said Dr. Rigel, a clinical professor of dermatology at New York University.

The pivotal study of the device included 1,383 patients. According to the company, MelaFind had a sensitivity of 98%. The device’s sensitivity rating for malignant melanoma was significantly better than that of dermatologists, who showed a wide range of variability about which lesions would have been recommended for biopsy and which relegated to observation.

MelaFind will also soon be available in Germany, which has some of the highest rates of melanoma in Europe, said Dr. Gulfo. The device received European Union approval in September. The company aims to have about 75 systems in Germany by next September, Dr. Gulfo said.

The Food and Drug Administration has deemed MelaFind, a noninvasive melanoma detection device, approvable, according to the manufacturer.

The FDA still has a list of requirements the manufacturer, Mela Sciences, must fulfill before MelaFind is given final approval. But company CEO, Joseph V. Gulfo, M.D., said in a conference call with analysts that much of the work is already done and that he expects no significant delays to market.

Photo courtesy Mela Sciences

The road to approval has been somewhat rocky. In November 2010, an FDA advisory panel split 8-7, with one abstention over whether MelaFind should be approved.

Then in May 2011, the company submitted a Citizen Petition to the FDA seeking action on its application for approval.

The company will have to work with the FDA on physician and patient labeling, a package insert and user’s guide, a training program for dermatologists, and the protocol for a postmarketing study.

Dr. Gulfo said that he expects MelaFind to be commercially available in the spring of 2012. Initially, it will only be sold to a handful of dermatologists in Connecticut, New Jersey, and New York. Mela Sciences will be working with dermatologists to fine tune the device before rolling it out to a larger number of practices, he said.

MelaFind is a multispectral computer vision system with a handheld imager that captures the image of a lesion; software uses algorithms to analyze the image, indicating within 2 minutes whether a biopsy should be done.

At the FDA panel meeting in November, some advisers expressed concern that MelaFind might be used by nondermatologists or that it would be used in place of clinical evaluation.

Mela Sciences and the FDA worked on clarifying the indications for use. Those indications now cover multiple paragraphs. According to a Mela Sciences press release, the device "is intended for use on clinically atypical cutaneous pigmented lesions with one or more clinical or historical characteristics of melanoma, excluding those with a clinical diagnosis of melanoma or likely melanoma."

Photo courtesy Mela Sciences

Labeling will also state that the device is "only for use by physicians trained in the clinical diagnosis and management of skin cancer (i.e., dermatologists) who have also successfully completed a training program in the appropriate use of MelaFind."

Dr. Darrell S. Rigel, a consultant for Mela Sciences, said in the company statement that the device can help dermatologists decide which lesions to biopsy and will be an aid to clinical evaluation. "While there have been incremental improvements in imaging tools for melanoma detection, we still primarily rely on our judgment based on a visual examination to select the lesions to biopsy; data show that this is often not enough," said Dr. Rigel, a clinical professor of dermatology at New York University.

The pivotal study of the device included 1,383 patients. According to the company, MelaFind had a sensitivity of 98%. The device’s sensitivity rating for malignant melanoma was significantly better than that of dermatologists, who showed a wide range of variability about which lesions would have been recommended for biopsy and which relegated to observation.

MelaFind will also soon be available in Germany, which has some of the highest rates of melanoma in Europe, said Dr. Gulfo. The device received European Union approval in September. The company aims to have about 75 systems in Germany by next September, Dr. Gulfo said.