Alicia Ault

Retail clinics appear to offer cost-effective, high-quality care, at least for three common conditions: urinary tract infections, otitis media, and pharyngitis, according to a recent study.

For insured patients, the cost of caring for these three illnesses was 30%-40% less at retail clinics than in physician offices and urgent care centers, and a whopping 80% less than in emergency departments, according to researchers at the RAND Corp., the University of Pittsburgh, and HealthPartners Research Foundation of Minneapolis.

Care cost less at the retail clinics because they are reimbursed at a lower rate for evaluation and management and they order fewer tests and imaging studies, the authors wrote (Ann. Intern. Med. 2009;151:321–9). They analyzed claims data from enrollees at HealthPartners, a Minneapolis-based health plan that covers care at retail clinics.

The study showed “that patients can feel safe in going to these retail health clinics for fairly limited, minor problems,” Dr. Ted Epperly, president of the American Academy of Family Physicians, said in an interview. But the analysis did not show that retail clinics are appropriate for older patients who may have more complex problems and a host of comorbidities, he said.

The study predominately covered enrollees who were aged 2–44 years, with a small percentage aged 45–64. There were only three enrollees over age 65 in the database. The authors compared the cost and quality of care and delivery of services for the three acute conditions in retail clinics with the cost and quality of care received in physician offices, urgent care centers, and emergency departments.

Dr. Yul D. Ejnes, a member of the American College of Physicians' board of regents and chair of the ACP's medical service committee, said he wasn't surprised by the findings for this population and for these three conditions.

But he said he did not think the findings would translate to older patients or even similar age groups at retail clinics elsewhere in the United States. Retail clinics began in Minnesota and are well-established there, according to the study authors.

The study is reassuring, Dr. Ejnes said in an interview, but “I don't think it puts to rest the other issues and concerns.”

One concern is that the retail clinics may usurp or interrupt a patient's relationship with his or her primary care physician. Both Dr. Ejnes and Dr. Epperly said that an acute care visit for a UTI, for example, provides an occasion for the physician to delve into other health issues, including chronic conditions. That would not occur at a retail clinic, they said.

Lead author Dr. Ateev Mehrotra of the University of Pittsburgh said the potential for undermining the patient's relationship with the primary care physician is a valid concern. He hopes to look at this aspect of retail clinics in future studies, Dr. Mehrotra said in an interview.

For this study, the costs were calculated by aggregating claims into episodes of care. Episodes were categorized according to where the first visit occurred. Retail clinic episodes were matched with episodes in the other settings. Overall, there were 15,170 episodes of care, with 2,100 occurring in retail settings, 6,211 in physician offices, 5,880 in urgent care centers, and 979 in emergency departments. The cost included the health plan reimbursement plus copayments.

To measure quality, the researchers created 14 indicators, derived from various sources. Aggregate quality scores were calculated by dividing all instances in which recommended care was delivered by the number of times patients were eligible to receive care in each setting.

The authors found that women and high-income individuals accounted for the greatest number of retail clinic episodes.

The cost of care was “substantially” lower in retail clinics, at $110, compared with $166 in a physician's office, $156 in an urgent care center, and $570 in an emergency department. Total costs over 12 months were $1,236 for the retail clinic, $1,435 for the physician office, and $2,157 for the emergency department. The largest portion of the cost was for evaluation and management. Follow-up visits were similar across settings. Lab and imaging costs were lower in retail clinics, primarily because they weren't ordered as often.

Of the total 15,170 episodes, there were only 11 hospitalizations; two of the hospitalized patients had first gone to a retail clinic.

The quality scores were almost the same for retail clinics, physician offices, and urgent care centers, with clinics meeting 63% of the measures, physicians 61%, and urgent care centers 63%. Aggregate quality scores were lower for emergency departments, at 55%.

Dr. Mehrotra acknowledged that the study had many limitations, including that the patients who were randomly selected happened to be healthier than the average HealthPartners enrollee. Also, there are no data indicating that the cost and quality findings for these conditions are true for other conditions. But Dr. Mehrotra said he had no reason to believe that the data could not be extrapolated to other simple, acute conditions.

The study was funded by the California HealthCare Foundation, an independent philanthropic organization. Dr. Mehrotra's research is also supported by a National Institutes of Health career development grant.

Retail clinics appear to offer cost-effective, high-quality care, at least for three common conditions: urinary tract infections, otitis media, and pharyngitis, according to a recent study.

For insured patients, the cost of caring for these three illnesses was 30%-40% less at retail clinics than in physician offices and urgent care centers, and a whopping 80% less than in emergency departments, according to researchers at the RAND Corp., the University of Pittsburgh, and HealthPartners Research Foundation of Minneapolis.

Care cost less at the retail clinics because they are reimbursed at a lower rate for evaluation and management and they order fewer tests and imaging studies, the authors wrote (Ann. Intern. Med. 2009;151:321–9). They analyzed claims data from enrollees at HealthPartners, a Minneapolis-based health plan that covers care at retail clinics.

The study showed “that patients can feel safe in going to these retail health clinics for fairly limited, minor problems,” Dr. Ted Epperly, president of the American Academy of Family Physicians, said in an interview. But the analysis did not show that retail clinics are appropriate for older patients who may have more complex problems and a host of comorbidities, he said.

The study predominately covered enrollees who were aged 2–44 years, with a small percentage aged 45–64. There were only three enrollees over age 65 in the database. The authors compared the cost and quality of care and delivery of services for the three acute conditions in retail clinics with the cost and quality of care received in physician offices, urgent care centers, and emergency departments.

Dr. Yul D. Ejnes, a member of the American College of Physicians' board of regents and chair of the ACP's medical service committee, said he wasn't surprised by the findings for this population and for these three conditions.

But he said he did not think the findings would translate to older patients or even similar age groups at retail clinics elsewhere in the United States. Retail clinics began in Minnesota and are well-established there, according to the study authors.

The study is reassuring, Dr. Ejnes said in an interview, but “I don't think it puts to rest the other issues and concerns.”

One concern is that the retail clinics may usurp or interrupt a patient's relationship with his or her primary care physician. Both Dr. Ejnes and Dr. Epperly said that an acute care visit for a UTI, for example, provides an occasion for the physician to delve into other health issues, including chronic conditions. That would not occur at a retail clinic, they said.

Lead author Dr. Ateev Mehrotra of the University of Pittsburgh said the potential for undermining the patient's relationship with the primary care physician is a valid concern. He hopes to look at this aspect of retail clinics in future studies, Dr. Mehrotra said in an interview.

For this study, the costs were calculated by aggregating claims into episodes of care. Episodes were categorized according to where the first visit occurred. Retail clinic episodes were matched with episodes in the other settings. Overall, there were 15,170 episodes of care, with 2,100 occurring in retail settings, 6,211 in physician offices, 5,880 in urgent care centers, and 979 in emergency departments. The cost included the health plan reimbursement plus copayments.

To measure quality, the researchers created 14 indicators, derived from various sources. Aggregate quality scores were calculated by dividing all instances in which recommended care was delivered by the number of times patients were eligible to receive care in each setting.

The authors found that women and high-income individuals accounted for the greatest number of retail clinic episodes.

The cost of care was “substantially” lower in retail clinics, at $110, compared with $166 in a physician's office, $156 in an urgent care center, and $570 in an emergency department. Total costs over 12 months were $1,236 for the retail clinic, $1,435 for the physician office, and $2,157 for the emergency department. The largest portion of the cost was for evaluation and management. Follow-up visits were similar across settings. Lab and imaging costs were lower in retail clinics, primarily because they weren't ordered as often.

Of the total 15,170 episodes, there were only 11 hospitalizations; two of the hospitalized patients had first gone to a retail clinic.

The quality scores were almost the same for retail clinics, physician offices, and urgent care centers, with clinics meeting 63% of the measures, physicians 61%, and urgent care centers 63%. Aggregate quality scores were lower for emergency departments, at 55%.

Dr. Mehrotra acknowledged that the study had many limitations, including that the patients who were randomly selected happened to be healthier than the average HealthPartners enrollee. Also, there are no data indicating that the cost and quality findings for these conditions are true for other conditions. But Dr. Mehrotra said he had no reason to believe that the data could not be extrapolated to other simple, acute conditions.

The study was funded by the California HealthCare Foundation, an independent philanthropic organization. Dr. Mehrotra's research is also supported by a National Institutes of Health career development grant.

Retail clinics appear to offer cost-effective, high-quality care, at least for three common conditions: urinary tract infections, otitis media, and pharyngitis, according to a recent study.

For insured patients, the cost of caring for these three illnesses was 30%-40% less at retail clinics than in physician offices and urgent care centers, and a whopping 80% less than in emergency departments, according to researchers at the RAND Corp., the University of Pittsburgh, and HealthPartners Research Foundation of Minneapolis.

Care cost less at the retail clinics because they are reimbursed at a lower rate for evaluation and management and they order fewer tests and imaging studies, the authors wrote (Ann. Intern. Med. 2009;151:321–9). They analyzed claims data from enrollees at HealthPartners, a Minneapolis-based health plan that covers care at retail clinics.

The study showed “that patients can feel safe in going to these retail health clinics for fairly limited, minor problems,” Dr. Ted Epperly, president of the American Academy of Family Physicians, said in an interview. But the analysis did not show that retail clinics are appropriate for older patients who may have more complex problems and a host of comorbidities, he said.

The study predominately covered enrollees who were aged 2–44 years, with a small percentage aged 45–64. There were only three enrollees over age 65 in the database. The authors compared the cost and quality of care and delivery of services for the three acute conditions in retail clinics with the cost and quality of care received in physician offices, urgent care centers, and emergency departments.

Dr. Yul D. Ejnes, a member of the American College of Physicians' board of regents and chair of the ACP's medical service committee, said he wasn't surprised by the findings for this population and for these three conditions.

But he said he did not think the findings would translate to older patients or even similar age groups at retail clinics elsewhere in the United States. Retail clinics began in Minnesota and are well-established there, according to the study authors.

The study is reassuring, Dr. Ejnes said in an interview, but “I don't think it puts to rest the other issues and concerns.”

One concern is that the retail clinics may usurp or interrupt a patient's relationship with his or her primary care physician. Both Dr. Ejnes and Dr. Epperly said that an acute care visit for a UTI, for example, provides an occasion for the physician to delve into other health issues, including chronic conditions. That would not occur at a retail clinic, they said.

Lead author Dr. Ateev Mehrotra of the University of Pittsburgh said the potential for undermining the patient's relationship with the primary care physician is a valid concern. He hopes to look at this aspect of retail clinics in future studies, Dr. Mehrotra said in an interview.

For this study, the costs were calculated by aggregating claims into episodes of care. Episodes were categorized according to where the first visit occurred. Retail clinic episodes were matched with episodes in the other settings. Overall, there were 15,170 episodes of care, with 2,100 occurring in retail settings, 6,211 in physician offices, 5,880 in urgent care centers, and 979 in emergency departments. The cost included the health plan reimbursement plus copayments.

To measure quality, the researchers created 14 indicators, derived from various sources. Aggregate quality scores were calculated by dividing all instances in which recommended care was delivered by the number of times patients were eligible to receive care in each setting.

The authors found that women and high-income individuals accounted for the greatest number of retail clinic episodes.

The cost of care was “substantially” lower in retail clinics, at $110, compared with $166 in a physician's office, $156 in an urgent care center, and $570 in an emergency department. Total costs over 12 months were $1,236 for the retail clinic, $1,435 for the physician office, and $2,157 for the emergency department. The largest portion of the cost was for evaluation and management. Follow-up visits were similar across settings. Lab and imaging costs were lower in retail clinics, primarily because they weren't ordered as often.

Of the total 15,170 episodes, there were only 11 hospitalizations; two of the hospitalized patients had first gone to a retail clinic.

The quality scores were almost the same for retail clinics, physician offices, and urgent care centers, with clinics meeting 63% of the measures, physicians 61%, and urgent care centers 63%. Aggregate quality scores were lower for emergency departments, at 55%.

Dr. Mehrotra acknowledged that the study had many limitations, including that the patients who were randomly selected happened to be healthier than the average HealthPartners enrollee. Also, there are no data indicating that the cost and quality findings for these conditions are true for other conditions. But Dr. Mehrotra said he had no reason to believe that the data could not be extrapolated to other simple, acute conditions.

The study was funded by the California HealthCare Foundation, an independent philanthropic organization. Dr. Mehrotra's research is also supported by a National Institutes of Health career development grant.

Can't get enough Policy & Practice? Check out our new podcast each Monday. egmnblog.wordpress.com

New Codes for Cardiac CT

The American Medical Association's Current Procedural Terminology (CPT) panel has approved four new Category 1 codes for cardiac computed tomography, which replace current Category III codes. The new codes were the result of a joint effort by professional societies including the American College of Radiology and the Society of Cardiovascular Computed Tomography. The codes will go into effect Jan. 1, 2010. They are 75571 (calcium scoring), 75572 (pulmonary veins), 75573 (congenital heart disease), and 75574 (coronary CT angiography). Both relative value units for physician reimbursement and the payment rates for hospitals probably will be established this month. “This accomplishment represents a significant step forward to achieve broader patient access to this proven technology,” the society said in a statement.

Combination to Face New Rules

The Food and Drug Administration is proposing new postmarketing reporting requirements for products that are combinations of drugs, devices, and biologics. According to the FDA, a combination product can include a drug or biologic combined with a device, a biologic and a drug combined, or all three together. Combinations may be physically or chemically mixed, packaged together, or two separate products intended for use together. Until now, the agency acknowledged, there has been a “lack of regulatory clarity,” so many adverse events may not be reported, or are reported in ways that are difficult for the agency to track. The FDA published its proposal in the Oct. 1 Federal Register and is accepting comments until Dec. 30.

CMS Weighing Evidence on MRA

The Centers for Medicare and Medicaid Services has begun an analysis to determine whether Medicare should begin covering magnetic resonance angiography nationally. The agency said that its “blanket noncoverage of MRA for blood flow determination … is no longer supported by the available evidence.” Local contractors can decide whether to cover MRA while CMS studies the potential for national coverage. The agency was accepting comments through Nov. 6, and it expects to issue a proposed decision in early April 2010.

HHS Eyeing Imaging Pay

Some time during the fiscal year that began Oct. 1, the Department of Health and Human Services' Office of Inspector General will start reviewing Medicare's Part B payments to physicians for imaging services. The focus will include “the physician professional cost component, malpractice costs, and practice expense,” according to the OIG. For each service, staff will determine whether the payment “reflects the actual expenses incurred and whether the utilization rate reflects current industry practices.” The agency also said it would investigate diagnostic x-rays that are performed in emergency departments. Imaging there has increased, said the OIG, and in 2007 cost Medicare about $207 million in physician payments. While the report on imaging in emergency departments is due within the year, the overall imaging report probably will not be completed until FY2011, said the OIG.

Flat Growth for Imaging?

A new analysis by the Access to Medical Imaging Coalition claims that in 2008, physician use of imaging services expanded modestly for the second year in a row. The analysis—done for the coalition by the Moran Company—found that the use of CT, magnetic resonance imaging, positron emission tomography, and nuclear services grew by 1.1%, down from the 1.9% increase in 2007. There was even a decline in the use of screening mammography, according to the study. Mammography grew 0.15% in 2007, but fell off 0.20% in 2008. Dual-energy absorptiometry scans also declined by 0.4%, compared with 2007. “Contrary to the assumption that advanced imaging spending is rapidly increasing, the 2008 data appear to confirm the deceleration of imaging cost growth first observed in the 2007 data,” Don Moran, the company's president, said in a statement. A statement from the imaging coalition said that the Deficit Reduction Act of 2005 has had a huge impact on utilization, and that policy makers should take that into account when considering imaging reimbursement cuts.

Practice Revenues Decline

Medical practice revenues have fallen, possibly because of declining patient volumes and lower payments from people in financial hardship, according to the Medical Group Management Association. Medical practices responded by trimming overhead costs more than 1%, but that wasn't enough to offset shrinking revenues, the MGMA found in its 2009 practice cost survey. Multispecialty group practices saw a 1.9% decline in total medical revenue from 2008, with substantial drops in both the number of procedures and the number of patients. Bad debt in multispecialty group practices from fee-for-service charges increased 13% from 2006 to 2008.

NIH Grants Total $5 Billion

The National Institutes of Health has awarded more than 12,000 grants for $5 billion in stimulus package funds toward research in HIV, cancer, heart disease, and autism. Announced at a press conference by President Obama, the grants come from the American Recovery and Reinvestment Act passed and signed last spring. “This represents the single largest boost to biomedical research in history,” the president said. Some of the funds will be used to apply findings from the Human Genome Project to treatment and prevention of the target diseases. Other stimulus package funding was designated by the Department of Health and Human Services for chronic disease prevention and wellness programs as well as for information technology at large federally funded health centers. The Centers for Disease Control and Prevention will administer $373 million for the chronic disease programs and community-based approaches that increase physical activity, improve nutrition, and decrease obesity. Eighteen grants totaling more than $22 million will fund information technology in medicine, the department said.

Can't get enough Policy & Practice? Check out our new podcast each Monday. egmnblog.wordpress.com

New Codes for Cardiac CT

The American Medical Association's Current Procedural Terminology (CPT) panel has approved four new Category 1 codes for cardiac computed tomography, which replace current Category III codes. The new codes were the result of a joint effort by professional societies including the American College of Radiology and the Society of Cardiovascular Computed Tomography. The codes will go into effect Jan. 1, 2010. They are 75571 (calcium scoring), 75572 (pulmonary veins), 75573 (congenital heart disease), and 75574 (coronary CT angiography). Both relative value units for physician reimbursement and the payment rates for hospitals probably will be established this month. “This accomplishment represents a significant step forward to achieve broader patient access to this proven technology,” the society said in a statement.

Combination to Face New Rules

The Food and Drug Administration is proposing new postmarketing reporting requirements for products that are combinations of drugs, devices, and biologics. According to the FDA, a combination product can include a drug or biologic combined with a device, a biologic and a drug combined, or all three together. Combinations may be physically or chemically mixed, packaged together, or two separate products intended for use together. Until now, the agency acknowledged, there has been a “lack of regulatory clarity,” so many adverse events may not be reported, or are reported in ways that are difficult for the agency to track. The FDA published its proposal in the Oct. 1 Federal Register and is accepting comments until Dec. 30.

CMS Weighing Evidence on MRA

The Centers for Medicare and Medicaid Services has begun an analysis to determine whether Medicare should begin covering magnetic resonance angiography nationally. The agency said that its “blanket noncoverage of MRA for blood flow determination … is no longer supported by the available evidence.” Local contractors can decide whether to cover MRA while CMS studies the potential for national coverage. The agency was accepting comments through Nov. 6, and it expects to issue a proposed decision in early April 2010.

HHS Eyeing Imaging Pay

Some time during the fiscal year that began Oct. 1, the Department of Health and Human Services' Office of Inspector General will start reviewing Medicare's Part B payments to physicians for imaging services. The focus will include “the physician professional cost component, malpractice costs, and practice expense,” according to the OIG. For each service, staff will determine whether the payment “reflects the actual expenses incurred and whether the utilization rate reflects current industry practices.” The agency also said it would investigate diagnostic x-rays that are performed in emergency departments. Imaging there has increased, said the OIG, and in 2007 cost Medicare about $207 million in physician payments. While the report on imaging in emergency departments is due within the year, the overall imaging report probably will not be completed until FY2011, said the OIG.

Flat Growth for Imaging?

A new analysis by the Access to Medical Imaging Coalition claims that in 2008, physician use of imaging services expanded modestly for the second year in a row. The analysis—done for the coalition by the Moran Company—found that the use of CT, magnetic resonance imaging, positron emission tomography, and nuclear services grew by 1.1%, down from the 1.9% increase in 2007. There was even a decline in the use of screening mammography, according to the study. Mammography grew 0.15% in 2007, but fell off 0.20% in 2008. Dual-energy absorptiometry scans also declined by 0.4%, compared with 2007. “Contrary to the assumption that advanced imaging spending is rapidly increasing, the 2008 data appear to confirm the deceleration of imaging cost growth first observed in the 2007 data,” Don Moran, the company's president, said in a statement. A statement from the imaging coalition said that the Deficit Reduction Act of 2005 has had a huge impact on utilization, and that policy makers should take that into account when considering imaging reimbursement cuts.

Practice Revenues Decline

Medical practice revenues have fallen, possibly because of declining patient volumes and lower payments from people in financial hardship, according to the Medical Group Management Association. Medical practices responded by trimming overhead costs more than 1%, but that wasn't enough to offset shrinking revenues, the MGMA found in its 2009 practice cost survey. Multispecialty group practices saw a 1.9% decline in total medical revenue from 2008, with substantial drops in both the number of procedures and the number of patients. Bad debt in multispecialty group practices from fee-for-service charges increased 13% from 2006 to 2008.

NIH Grants Total $5 Billion

The National Institutes of Health has awarded more than 12,000 grants for $5 billion in stimulus package funds toward research in HIV, cancer, heart disease, and autism. Announced at a press conference by President Obama, the grants come from the American Recovery and Reinvestment Act passed and signed last spring. “This represents the single largest boost to biomedical research in history,” the president said. Some of the funds will be used to apply findings from the Human Genome Project to treatment and prevention of the target diseases. Other stimulus package funding was designated by the Department of Health and Human Services for chronic disease prevention and wellness programs as well as for information technology at large federally funded health centers. The Centers for Disease Control and Prevention will administer $373 million for the chronic disease programs and community-based approaches that increase physical activity, improve nutrition, and decrease obesity. Eighteen grants totaling more than $22 million will fund information technology in medicine, the department said.

Can't get enough Policy & Practice? Check out our new podcast each Monday. egmnblog.wordpress.com

New Codes for Cardiac CT

The American Medical Association's Current Procedural Terminology (CPT) panel has approved four new Category 1 codes for cardiac computed tomography, which replace current Category III codes. The new codes were the result of a joint effort by professional societies including the American College of Radiology and the Society of Cardiovascular Computed Tomography. The codes will go into effect Jan. 1, 2010. They are 75571 (calcium scoring), 75572 (pulmonary veins), 75573 (congenital heart disease), and 75574 (coronary CT angiography). Both relative value units for physician reimbursement and the payment rates for hospitals probably will be established this month. “This accomplishment represents a significant step forward to achieve broader patient access to this proven technology,” the society said in a statement.

Combination to Face New Rules

The Food and Drug Administration is proposing new postmarketing reporting requirements for products that are combinations of drugs, devices, and biologics. According to the FDA, a combination product can include a drug or biologic combined with a device, a biologic and a drug combined, or all three together. Combinations may be physically or chemically mixed, packaged together, or two separate products intended for use together. Until now, the agency acknowledged, there has been a “lack of regulatory clarity,” so many adverse events may not be reported, or are reported in ways that are difficult for the agency to track. The FDA published its proposal in the Oct. 1 Federal Register and is accepting comments until Dec. 30.

CMS Weighing Evidence on MRA

The Centers for Medicare and Medicaid Services has begun an analysis to determine whether Medicare should begin covering magnetic resonance angiography nationally. The agency said that its “blanket noncoverage of MRA for blood flow determination … is no longer supported by the available evidence.” Local contractors can decide whether to cover MRA while CMS studies the potential for national coverage. The agency was accepting comments through Nov. 6, and it expects to issue a proposed decision in early April 2010.

HHS Eyeing Imaging Pay

Some time during the fiscal year that began Oct. 1, the Department of Health and Human Services' Office of Inspector General will start reviewing Medicare's Part B payments to physicians for imaging services. The focus will include “the physician professional cost component, malpractice costs, and practice expense,” according to the OIG. For each service, staff will determine whether the payment “reflects the actual expenses incurred and whether the utilization rate reflects current industry practices.” The agency also said it would investigate diagnostic x-rays that are performed in emergency departments. Imaging there has increased, said the OIG, and in 2007 cost Medicare about $207 million in physician payments. While the report on imaging in emergency departments is due within the year, the overall imaging report probably will not be completed until FY2011, said the OIG.

Flat Growth for Imaging?

A new analysis by the Access to Medical Imaging Coalition claims that in 2008, physician use of imaging services expanded modestly for the second year in a row. The analysis—done for the coalition by the Moran Company—found that the use of CT, magnetic resonance imaging, positron emission tomography, and nuclear services grew by 1.1%, down from the 1.9% increase in 2007. There was even a decline in the use of screening mammography, according to the study. Mammography grew 0.15% in 2007, but fell off 0.20% in 2008. Dual-energy absorptiometry scans also declined by 0.4%, compared with 2007. “Contrary to the assumption that advanced imaging spending is rapidly increasing, the 2008 data appear to confirm the deceleration of imaging cost growth first observed in the 2007 data,” Don Moran, the company's president, said in a statement. A statement from the imaging coalition said that the Deficit Reduction Act of 2005 has had a huge impact on utilization, and that policy makers should take that into account when considering imaging reimbursement cuts.

Practice Revenues Decline

Medical practice revenues have fallen, possibly because of declining patient volumes and lower payments from people in financial hardship, according to the Medical Group Management Association. Medical practices responded by trimming overhead costs more than 1%, but that wasn't enough to offset shrinking revenues, the MGMA found in its 2009 practice cost survey. Multispecialty group practices saw a 1.9% decline in total medical revenue from 2008, with substantial drops in both the number of procedures and the number of patients. Bad debt in multispecialty group practices from fee-for-service charges increased 13% from 2006 to 2008.

NIH Grants Total $5 Billion

The National Institutes of Health has awarded more than 12,000 grants for $5 billion in stimulus package funds toward research in HIV, cancer, heart disease, and autism. Announced at a press conference by President Obama, the grants come from the American Recovery and Reinvestment Act passed and signed last spring. “This represents the single largest boost to biomedical research in history,” the president said. Some of the funds will be used to apply findings from the Human Genome Project to treatment and prevention of the target diseases. Other stimulus package funding was designated by the Department of Health and Human Services for chronic disease prevention and wellness programs as well as for information technology at large federally funded health centers. The Centers for Disease Control and Prevention will administer $373 million for the chronic disease programs and community-based approaches that increase physical activity, improve nutrition, and decrease obesity. Eighteen grants totaling more than $22 million will fund information technology in medicine, the department said.

A continued wide disparity in access to and quality of care across the United States argues strongly for a national health reform plan, according to executives at the Commonwealth Fund, who released a state-by-state survey of 38 health indicators.

According to the Commonwealth Fund survey, there is a fivefold difference in performance on the indicators between the highest-ranked states and the lowest. “The differences we see among the states translate to real lives and real dollars,” Karen Davis, president of the Commonwealth Fund, said at a press conference. “In the richest country in the world, there is no justification for any state to be far below the best state for quality and access to health care.”

Health reform legislation under consideration in Congress would go a long way toward improving access and coverage, and that would increase quality overall, Ms. Davis said.

This is the second time the nonprofit group has taken a microscopic look at issues of cost, quality, and access in each state and the District of Columbia. Since the first report card in 2007, the number of uninsured adults has risen—and this survey was done on the eve of the recession, so the “worst is yet to come,” according to Cathy Schoen, senior vice president of the Commonwealth Fund.

Coverage for children, however, has remained steady or improved, thanks to the federally supported Children's Health Insurance Program (CHIP), Ms. Schoen said.

States in the top quartile have been top performers in previous scorecards and have higher rates of insured adults and children, better access to primary care, and lower mortality from preventable diseases, among other indicators. The top quartile comprises Connecticut, Hawaii, Iowa, Maine, Massachusetts, Minnesota, Nebraska, New Hampshire, North Dakota, Rhode Island, South Dakota, Vermont, and Wisconsin.

Ten of the 13 states in the lowest quartile—Alabama, Arkansas, Florida, Kentucky, Louisiana, Mississippi, Oklahoma, Nevada, Tennessee, and Texas—also ranked at the bottom on the previous 2007 report. Illinois, New Mexico, and North Carolina dropped into the lowest quartile since the last survey, while California, Georgia, and West Virginia moved up out of the last quartile in this most recent report. The lower-performing states had rates of uninsured adults and children that were double those in the top quartile.

The uninsured and those with low incomes tended to have poorer access to care and to receive a lower quality of care, Ms. Schoen said.

The report also reflected some bright spots: The quality of hospital care for heart attack, heart failure, pneumonia, and the prevention of surgical complications improved dramatically for all states, as did the quality of nursing home care. The Commonwealth Fund attributed the improvements to the increasing national efforts to measure and benchmark performance, including Medicare's Hospital Compare and Nursing Home Compare Web sites.

Conversely, data on ambulatory care quality are sorely lacking, Ms. Schoen said. From what can be gleaned, states' performance on preventive care stayed the same or declined. And poor coordination of care is resulting in continued high—and increasing—rates of hospital readmissions, according to the scorecard.

Ms. Davis touted the patient-centered medical home as a way to improve performance in preventive care, ambula-tory care, and hospital readmissions. She said that 31 states are sponsoring medical home projects, and that the Commonwealth Fund is supporting efforts in Colorado, Idaho, Massachusetts, Oregon, and Pennsylvania to help safety net clinics become medical homes.

According to Ms. Davis and her colleagues, if the lower-performing states were helped to reach the levels of the higher-performing states, 29 million more people would be insured; 78,000 fewer adults and children would die prematurely each year from preventable conditions; 9 million more adults aged 50 years and older would receive recommended preventive care; and almost 800,000 more children would receive key vaccinations.

The organization also said that the nation could realize $5 billion in savings a year by avoiding preventable admissions and readmissions.

A continued wide disparity in access to and quality of care across the United States argues strongly for a national health reform plan, according to executives at the Commonwealth Fund, who released a state-by-state survey of 38 health indicators.

According to the Commonwealth Fund survey, there is a fivefold difference in performance on the indicators between the highest-ranked states and the lowest. “The differences we see among the states translate to real lives and real dollars,” Karen Davis, president of the Commonwealth Fund, said at a press conference. “In the richest country in the world, there is no justification for any state to be far below the best state for quality and access to health care.”

Health reform legislation under consideration in Congress would go a long way toward improving access and coverage, and that would increase quality overall, Ms. Davis said.

This is the second time the nonprofit group has taken a microscopic look at issues of cost, quality, and access in each state and the District of Columbia. Since the first report card in 2007, the number of uninsured adults has risen—and this survey was done on the eve of the recession, so the “worst is yet to come,” according to Cathy Schoen, senior vice president of the Commonwealth Fund.

Coverage for children, however, has remained steady or improved, thanks to the federally supported Children's Health Insurance Program (CHIP), Ms. Schoen said.

States in the top quartile have been top performers in previous scorecards and have higher rates of insured adults and children, better access to primary care, and lower mortality from preventable diseases, among other indicators. The top quartile comprises Connecticut, Hawaii, Iowa, Maine, Massachusetts, Minnesota, Nebraska, New Hampshire, North Dakota, Rhode Island, South Dakota, Vermont, and Wisconsin.

Ten of the 13 states in the lowest quartile—Alabama, Arkansas, Florida, Kentucky, Louisiana, Mississippi, Oklahoma, Nevada, Tennessee, and Texas—also ranked at the bottom on the previous 2007 report. Illinois, New Mexico, and North Carolina dropped into the lowest quartile since the last survey, while California, Georgia, and West Virginia moved up out of the last quartile in this most recent report. The lower-performing states had rates of uninsured adults and children that were double those in the top quartile.

The uninsured and those with low incomes tended to have poorer access to care and to receive a lower quality of care, Ms. Schoen said.

The report also reflected some bright spots: The quality of hospital care for heart attack, heart failure, pneumonia, and the prevention of surgical complications improved dramatically for all states, as did the quality of nursing home care. The Commonwealth Fund attributed the improvements to the increasing national efforts to measure and benchmark performance, including Medicare's Hospital Compare and Nursing Home Compare Web sites.

Conversely, data on ambulatory care quality are sorely lacking, Ms. Schoen said. From what can be gleaned, states' performance on preventive care stayed the same or declined. And poor coordination of care is resulting in continued high—and increasing—rates of hospital readmissions, according to the scorecard.

Ms. Davis touted the patient-centered medical home as a way to improve performance in preventive care, ambula-tory care, and hospital readmissions. She said that 31 states are sponsoring medical home projects, and that the Commonwealth Fund is supporting efforts in Colorado, Idaho, Massachusetts, Oregon, and Pennsylvania to help safety net clinics become medical homes.

According to Ms. Davis and her colleagues, if the lower-performing states were helped to reach the levels of the higher-performing states, 29 million more people would be insured; 78,000 fewer adults and children would die prematurely each year from preventable conditions; 9 million more adults aged 50 years and older would receive recommended preventive care; and almost 800,000 more children would receive key vaccinations.

The organization also said that the nation could realize $5 billion in savings a year by avoiding preventable admissions and readmissions.

A continued wide disparity in access to and quality of care across the United States argues strongly for a national health reform plan, according to executives at the Commonwealth Fund, who released a state-by-state survey of 38 health indicators.

According to the Commonwealth Fund survey, there is a fivefold difference in performance on the indicators between the highest-ranked states and the lowest. “The differences we see among the states translate to real lives and real dollars,” Karen Davis, president of the Commonwealth Fund, said at a press conference. “In the richest country in the world, there is no justification for any state to be far below the best state for quality and access to health care.”

Health reform legislation under consideration in Congress would go a long way toward improving access and coverage, and that would increase quality overall, Ms. Davis said.

This is the second time the nonprofit group has taken a microscopic look at issues of cost, quality, and access in each state and the District of Columbia. Since the first report card in 2007, the number of uninsured adults has risen—and this survey was done on the eve of the recession, so the “worst is yet to come,” according to Cathy Schoen, senior vice president of the Commonwealth Fund.

Coverage for children, however, has remained steady or improved, thanks to the federally supported Children's Health Insurance Program (CHIP), Ms. Schoen said.

States in the top quartile have been top performers in previous scorecards and have higher rates of insured adults and children, better access to primary care, and lower mortality from preventable diseases, among other indicators. The top quartile comprises Connecticut, Hawaii, Iowa, Maine, Massachusetts, Minnesota, Nebraska, New Hampshire, North Dakota, Rhode Island, South Dakota, Vermont, and Wisconsin.

Ten of the 13 states in the lowest quartile—Alabama, Arkansas, Florida, Kentucky, Louisiana, Mississippi, Oklahoma, Nevada, Tennessee, and Texas—also ranked at the bottom on the previous 2007 report. Illinois, New Mexico, and North Carolina dropped into the lowest quartile since the last survey, while California, Georgia, and West Virginia moved up out of the last quartile in this most recent report. The lower-performing states had rates of uninsured adults and children that were double those in the top quartile.

The uninsured and those with low incomes tended to have poorer access to care and to receive a lower quality of care, Ms. Schoen said.

The report also reflected some bright spots: The quality of hospital care for heart attack, heart failure, pneumonia, and the prevention of surgical complications improved dramatically for all states, as did the quality of nursing home care. The Commonwealth Fund attributed the improvements to the increasing national efforts to measure and benchmark performance, including Medicare's Hospital Compare and Nursing Home Compare Web sites.

Conversely, data on ambulatory care quality are sorely lacking, Ms. Schoen said. From what can be gleaned, states' performance on preventive care stayed the same or declined. And poor coordination of care is resulting in continued high—and increasing—rates of hospital readmissions, according to the scorecard.

Ms. Davis touted the patient-centered medical home as a way to improve performance in preventive care, ambula-tory care, and hospital readmissions. She said that 31 states are sponsoring medical home projects, and that the Commonwealth Fund is supporting efforts in Colorado, Idaho, Massachusetts, Oregon, and Pennsylvania to help safety net clinics become medical homes.

According to Ms. Davis and her colleagues, if the lower-performing states were helped to reach the levels of the higher-performing states, 29 million more people would be insured; 78,000 fewer adults and children would die prematurely each year from preventable conditions; 9 million more adults aged 50 years and older would receive recommended preventive care; and almost 800,000 more children would receive key vaccinations.

The organization also said that the nation could realize $5 billion in savings a year by avoiding preventable admissions and readmissions.

Hard Times and Mental Stress

No surprise here: A national survey found that the unemployed are far more likely than others to report severe mental distress. Mental Health America and the National Alliance on Mental Illness (NAMI) surveyed 1,002 adults (half men, half women) nationwide in mid-September. About 13% of those without jobs said they'd had thoughts of harming themselves–four times the rate of people with jobs. Unemployed people were also twice as likely to say they were concerned about their mental health or had used alcohol or drugs in the past 6 months. Among those who had not consulted a health provider about their concerns, 42% said that lack of insurance coverage or cost was the main impediment.

Phone Intervention Effective

A structured phone intervention appears to be as effective as in-office primary care visits when it comes to managing patients receiving antidepression therapy, according to a study from the Group Health Cooperative's Center for Health Studies in Seattle. Patients starting antidepressants were invited to be randomized into a trial comparing two telephone-support programs with standard care (Arch. Gen. Psychiatry 2009;66:1081-9). One telephone group received up to five brief calls or personalized mailings from care managers with bachelor's degree–level training. The second group got up to 12 calls, which included care management and structured cognitive-behavioral psychotherapy delivered by clinicians with master's degree–level training and psychotherapy experience. For effectiveness assessment, patients were contacted 1 month after entering the study and every 3 months thereafter, for a year and half. Each time, they were assessed on the Symptom Checklist 90 depression scale. Both phone programs had long-term clinical benefits but a greater impact was seen from the intervention that included therapy.

Gene Centers of Excellence

The National Human Genome Research Institute and the National Institute of Mental Health are awarding $45 million in grants to establish two new Centers of Excellence in Genomic Science in Wisconsin and North Carolina and to support existing centers at the University of Southern California, Los Angeles, and Johns Hopkins University, Baltimore. The Medical College of Wisconsin, Milwaukee, and the University of Wisconsin, Madison, will codirect a center, and the University of North Carolina, Chapel Hill, will establish the other new center. In North Carolina, researchers are developing new approaches to identifying genetic and environmental factors that may contribute to psychiatric disorders. The Johns Hopkins researchers plan to study in bipolar disorder, aging, and autism.

Levamisole-Laced Cocaine

The Drug Enforcement Administration and the Substance Abuse and Mental Health Services Administration are warning health providers and treatment centers that “substantial levels” of cocaine may be adulterated with levamisole, a veterinary drug. SAMHSA said there have been 20 confirmed or probable cases of agranulocytosis, including 2 deaths, in people who had ingested cocaine that was mixed with the antiparasite agent, which can suppress white blood cell counts. Levamisole was once used in human chemotherapy but is no longer approved for that indication. The DEA reported that levamisole has been found in cocaine samples since 2002. An analysis in July concluded that 70% of cocaine samples contained levamisole. SAMHSA, the DEA, the Food and Drug Administration, the Centers for Disease Control and Prevention, and the Office of National Drug Control Policy are gathering case reports from state health departments. So far, there has been no uptick in cases of cocaine-related agranulocytosis, but reporting probably lags behind occurrences.

Practice Revenues Decline

Medical practice revenues fell in 2008, possibly because of declining patient volumes and payments from people in financial hardship, according to the Medical Group Management Association. Medical practices responded by trimming overhead costs more than 1%, but that wasn't enough to offset shrinking revenues, the MGMA found in its yearly practice-cost survey. Multispecialty group practices saw a 1.9% decline in total medical revenue in 2008, with substantial drops in both the number of procedures and the number of patients. Bad debt in multispecialty group practices from fee-for-service charges increased 13% from 2006 to 2008. Practices trimmed their expenses mostly by cutting support-staff costs. However, total worker count remained constant, suggesting that practices might have eliminated raises and bonuses or even cut pay, the MGMA said.

Hard Times and Mental Stress

No surprise here: A national survey found that the unemployed are far more likely than others to report severe mental distress. Mental Health America and the National Alliance on Mental Illness (NAMI) surveyed 1,002 adults (half men, half women) nationwide in mid-September. About 13% of those without jobs said they'd had thoughts of harming themselves–four times the rate of people with jobs. Unemployed people were also twice as likely to say they were concerned about their mental health or had used alcohol or drugs in the past 6 months. Among those who had not consulted a health provider about their concerns, 42% said that lack of insurance coverage or cost was the main impediment.

Phone Intervention Effective

A structured phone intervention appears to be as effective as in-office primary care visits when it comes to managing patients receiving antidepression therapy, according to a study from the Group Health Cooperative's Center for Health Studies in Seattle. Patients starting antidepressants were invited to be randomized into a trial comparing two telephone-support programs with standard care (Arch. Gen. Psychiatry 2009;66:1081-9). One telephone group received up to five brief calls or personalized mailings from care managers with bachelor's degree–level training. The second group got up to 12 calls, which included care management and structured cognitive-behavioral psychotherapy delivered by clinicians with master's degree–level training and psychotherapy experience. For effectiveness assessment, patients were contacted 1 month after entering the study and every 3 months thereafter, for a year and half. Each time, they were assessed on the Symptom Checklist 90 depression scale. Both phone programs had long-term clinical benefits but a greater impact was seen from the intervention that included therapy.

Gene Centers of Excellence

The National Human Genome Research Institute and the National Institute of Mental Health are awarding $45 million in grants to establish two new Centers of Excellence in Genomic Science in Wisconsin and North Carolina and to support existing centers at the University of Southern California, Los Angeles, and Johns Hopkins University, Baltimore. The Medical College of Wisconsin, Milwaukee, and the University of Wisconsin, Madison, will codirect a center, and the University of North Carolina, Chapel Hill, will establish the other new center. In North Carolina, researchers are developing new approaches to identifying genetic and environmental factors that may contribute to psychiatric disorders. The Johns Hopkins researchers plan to study in bipolar disorder, aging, and autism.

Levamisole-Laced Cocaine

The Drug Enforcement Administration and the Substance Abuse and Mental Health Services Administration are warning health providers and treatment centers that “substantial levels” of cocaine may be adulterated with levamisole, a veterinary drug. SAMHSA said there have been 20 confirmed or probable cases of agranulocytosis, including 2 deaths, in people who had ingested cocaine that was mixed with the antiparasite agent, which can suppress white blood cell counts. Levamisole was once used in human chemotherapy but is no longer approved for that indication. The DEA reported that levamisole has been found in cocaine samples since 2002. An analysis in July concluded that 70% of cocaine samples contained levamisole. SAMHSA, the DEA, the Food and Drug Administration, the Centers for Disease Control and Prevention, and the Office of National Drug Control Policy are gathering case reports from state health departments. So far, there has been no uptick in cases of cocaine-related agranulocytosis, but reporting probably lags behind occurrences.

Practice Revenues Decline

Medical practice revenues fell in 2008, possibly because of declining patient volumes and payments from people in financial hardship, according to the Medical Group Management Association. Medical practices responded by trimming overhead costs more than 1%, but that wasn't enough to offset shrinking revenues, the MGMA found in its yearly practice-cost survey. Multispecialty group practices saw a 1.9% decline in total medical revenue in 2008, with substantial drops in both the number of procedures and the number of patients. Bad debt in multispecialty group practices from fee-for-service charges increased 13% from 2006 to 2008. Practices trimmed their expenses mostly by cutting support-staff costs. However, total worker count remained constant, suggesting that practices might have eliminated raises and bonuses or even cut pay, the MGMA said.

Hard Times and Mental Stress

No surprise here: A national survey found that the unemployed are far more likely than others to report severe mental distress. Mental Health America and the National Alliance on Mental Illness (NAMI) surveyed 1,002 adults (half men, half women) nationwide in mid-September. About 13% of those without jobs said they'd had thoughts of harming themselves–four times the rate of people with jobs. Unemployed people were also twice as likely to say they were concerned about their mental health or had used alcohol or drugs in the past 6 months. Among those who had not consulted a health provider about their concerns, 42% said that lack of insurance coverage or cost was the main impediment.

Phone Intervention Effective

A structured phone intervention appears to be as effective as in-office primary care visits when it comes to managing patients receiving antidepression therapy, according to a study from the Group Health Cooperative's Center for Health Studies in Seattle. Patients starting antidepressants were invited to be randomized into a trial comparing two telephone-support programs with standard care (Arch. Gen. Psychiatry 2009;66:1081-9). One telephone group received up to five brief calls or personalized mailings from care managers with bachelor's degree–level training. The second group got up to 12 calls, which included care management and structured cognitive-behavioral psychotherapy delivered by clinicians with master's degree–level training and psychotherapy experience. For effectiveness assessment, patients were contacted 1 month after entering the study and every 3 months thereafter, for a year and half. Each time, they were assessed on the Symptom Checklist 90 depression scale. Both phone programs had long-term clinical benefits but a greater impact was seen from the intervention that included therapy.

Gene Centers of Excellence

The National Human Genome Research Institute and the National Institute of Mental Health are awarding $45 million in grants to establish two new Centers of Excellence in Genomic Science in Wisconsin and North Carolina and to support existing centers at the University of Southern California, Los Angeles, and Johns Hopkins University, Baltimore. The Medical College of Wisconsin, Milwaukee, and the University of Wisconsin, Madison, will codirect a center, and the University of North Carolina, Chapel Hill, will establish the other new center. In North Carolina, researchers are developing new approaches to identifying genetic and environmental factors that may contribute to psychiatric disorders. The Johns Hopkins researchers plan to study in bipolar disorder, aging, and autism.

Levamisole-Laced Cocaine

The Drug Enforcement Administration and the Substance Abuse and Mental Health Services Administration are warning health providers and treatment centers that “substantial levels” of cocaine may be adulterated with levamisole, a veterinary drug. SAMHSA said there have been 20 confirmed or probable cases of agranulocytosis, including 2 deaths, in people who had ingested cocaine that was mixed with the antiparasite agent, which can suppress white blood cell counts. Levamisole was once used in human chemotherapy but is no longer approved for that indication. The DEA reported that levamisole has been found in cocaine samples since 2002. An analysis in July concluded that 70% of cocaine samples contained levamisole. SAMHSA, the DEA, the Food and Drug Administration, the Centers for Disease Control and Prevention, and the Office of National Drug Control Policy are gathering case reports from state health departments. So far, there has been no uptick in cases of cocaine-related agranulocytosis, but reporting probably lags behind occurrences.

Practice Revenues Decline

Medical practice revenues fell in 2008, possibly because of declining patient volumes and payments from people in financial hardship, according to the Medical Group Management Association. Medical practices responded by trimming overhead costs more than 1%, but that wasn't enough to offset shrinking revenues, the MGMA found in its yearly practice-cost survey. Multispecialty group practices saw a 1.9% decline in total medical revenue in 2008, with substantial drops in both the number of procedures and the number of patients. Bad debt in multispecialty group practices from fee-for-service charges increased 13% from 2006 to 2008. Practices trimmed their expenses mostly by cutting support-staff costs. However, total worker count remained constant, suggesting that practices might have eliminated raises and bonuses or even cut pay, the MGMA said.

A continued wide disparity in access to and quality of care across the United States argues strongly for a national health reform plan, according to executives at the Commonwealth Fund, who released a state-by-state survey of 38 health indicators.

According to the survey, there is a fivefold difference in performance on the indicators between the highest-ranked states and the lowest. “The differences we see among the states translate to real lives and real dollars,” Karen Davis, president of the Commonwealth Fund, said at a press conference. “In the richest country in the world, there is no justification for any state to be far below the best state for quality and access to health care.”

Health reform legislation under consideration in Congress would go a long way toward improving access and coverage, and that would increase quality overall, Ms. Davis said.

Since 2007, the number of uninsured adults has risen—and this survey was done on the eve of the recession, so the “worst is yet to come,” according to Cathy Schoen, senior vice president of the Commonwealth Fund.

The top quartile comprises Connecticut, Hawaii, Iowa, Maine, Massachusetts, Minnesota, Nebraska, New Hampshire, North Dakota, Rhode Island, South Dakota, Vermont, and Wisconsin.

Ten of the 13 states in the lowest quartile—Alabama, Arkansas, Florida, Kentucky, Louisiana, Mississippi, Nevada, Oklahoma, Tennessee, and Texas—also ranked at the bottom on the previous 2007 report. Illinois, New Mexico, and North Carolina dropped into the lowest quartile since the last survey, while California, Georgia, and West Virginia moved up out of the last quartile in this most recent report. The lower-performing states had rates of uninsured adults and children that were double those in the top quartile.

The report also reflected some bright spots: The quality of hospital care for heart attack, heart failure, pneumonia, and the prevention of surgical complications improved dramatically for all states, as did the quality of nursing home care.

Conversely, data on ambulatory care quality are sorely lacking, Ms. Schoen said. From what can be gleaned, states' performance on preventive care stayed the same or declined.

According to Ms. Davis and her colleagues, if the lower-performing states were helped to reach the levels of the higher-performing states, 29 million more people would be insured; 78,000 fewer adults and children would die prematurely each year from preventable conditions; 9 million more adults aged 50 years and older would receive recommended preventive care; and almost 800,000 more children would receive key vaccinations.

The organization also said that the nation could realize $5 billion in savings a year by avoiding preventable admissions and readmissions.

A continued wide disparity in access to and quality of care across the United States argues strongly for a national health reform plan, according to executives at the Commonwealth Fund, who released a state-by-state survey of 38 health indicators.

According to the survey, there is a fivefold difference in performance on the indicators between the highest-ranked states and the lowest. “The differences we see among the states translate to real lives and real dollars,” Karen Davis, president of the Commonwealth Fund, said at a press conference. “In the richest country in the world, there is no justification for any state to be far below the best state for quality and access to health care.”

Health reform legislation under consideration in Congress would go a long way toward improving access and coverage, and that would increase quality overall, Ms. Davis said.

Since 2007, the number of uninsured adults has risen—and this survey was done on the eve of the recession, so the “worst is yet to come,” according to Cathy Schoen, senior vice president of the Commonwealth Fund.

The top quartile comprises Connecticut, Hawaii, Iowa, Maine, Massachusetts, Minnesota, Nebraska, New Hampshire, North Dakota, Rhode Island, South Dakota, Vermont, and Wisconsin.

Ten of the 13 states in the lowest quartile—Alabama, Arkansas, Florida, Kentucky, Louisiana, Mississippi, Nevada, Oklahoma, Tennessee, and Texas—also ranked at the bottom on the previous 2007 report. Illinois, New Mexico, and North Carolina dropped into the lowest quartile since the last survey, while California, Georgia, and West Virginia moved up out of the last quartile in this most recent report. The lower-performing states had rates of uninsured adults and children that were double those in the top quartile.

The report also reflected some bright spots: The quality of hospital care for heart attack, heart failure, pneumonia, and the prevention of surgical complications improved dramatically for all states, as did the quality of nursing home care.

Conversely, data on ambulatory care quality are sorely lacking, Ms. Schoen said. From what can be gleaned, states' performance on preventive care stayed the same or declined.

According to Ms. Davis and her colleagues, if the lower-performing states were helped to reach the levels of the higher-performing states, 29 million more people would be insured; 78,000 fewer adults and children would die prematurely each year from preventable conditions; 9 million more adults aged 50 years and older would receive recommended preventive care; and almost 800,000 more children would receive key vaccinations.

The organization also said that the nation could realize $5 billion in savings a year by avoiding preventable admissions and readmissions.

A continued wide disparity in access to and quality of care across the United States argues strongly for a national health reform plan, according to executives at the Commonwealth Fund, who released a state-by-state survey of 38 health indicators.

According to the survey, there is a fivefold difference in performance on the indicators between the highest-ranked states and the lowest. “The differences we see among the states translate to real lives and real dollars,” Karen Davis, president of the Commonwealth Fund, said at a press conference. “In the richest country in the world, there is no justification for any state to be far below the best state for quality and access to health care.”

Health reform legislation under consideration in Congress would go a long way toward improving access and coverage, and that would increase quality overall, Ms. Davis said.

Since 2007, the number of uninsured adults has risen—and this survey was done on the eve of the recession, so the “worst is yet to come,” according to Cathy Schoen, senior vice president of the Commonwealth Fund.

The top quartile comprises Connecticut, Hawaii, Iowa, Maine, Massachusetts, Minnesota, Nebraska, New Hampshire, North Dakota, Rhode Island, South Dakota, Vermont, and Wisconsin.

Ten of the 13 states in the lowest quartile—Alabama, Arkansas, Florida, Kentucky, Louisiana, Mississippi, Nevada, Oklahoma, Tennessee, and Texas—also ranked at the bottom on the previous 2007 report. Illinois, New Mexico, and North Carolina dropped into the lowest quartile since the last survey, while California, Georgia, and West Virginia moved up out of the last quartile in this most recent report. The lower-performing states had rates of uninsured adults and children that were double those in the top quartile.

The report also reflected some bright spots: The quality of hospital care for heart attack, heart failure, pneumonia, and the prevention of surgical complications improved dramatically for all states, as did the quality of nursing home care.

Conversely, data on ambulatory care quality are sorely lacking, Ms. Schoen said. From what can be gleaned, states' performance on preventive care stayed the same or declined.

According to Ms. Davis and her colleagues, if the lower-performing states were helped to reach the levels of the higher-performing states, 29 million more people would be insured; 78,000 fewer adults and children would die prematurely each year from preventable conditions; 9 million more adults aged 50 years and older would receive recommended preventive care; and almost 800,000 more children would receive key vaccinations.

The organization also said that the nation could realize $5 billion in savings a year by avoiding preventable admissions and readmissions.

A continued wide disparity in access to and quality of care across the United States argues strongly for a national health reform plan, according to executives at the Commonwealth Fund, who released a state-by-state survey of 38 health indicators.

According to the Commonwealth Fund survey, there is a fivefold difference in performance on the indicators between the highest-ranked states and the lowest. "The differences we see among the states translate to real lives and real dollars," Karen Davis, president of the Commonwealth Fund, said at a press conference. "In the richest country in the world, there is no justification for any state to be far below the best state for quality and access to health care."

Health reform legislation under consideration in Congress would go a long way toward improving access and coverage, and that would increase quality overall, Ms. Davis said.

This is the second time the nonprofit group has taken a microscopic look at issues of cost, quality, and access in each state and the District of Columbia. Since the first report card in 2007, the number of uninsured adults has risen—and this survey was done on the eve of the recession, so the "worst is yet to come," according to Cathy Schoen, senior vice president of the Commonwealth Fund.

Coverage for children, however, has remained steady or improved, thanks to the federally supported Children's Health Insurance Program (CHIP), Ms. Schoen said.

States in the top quartile have been top performers in previous scorecards and have higher rates of insured adults and children, better access to primary care, and lower mortality from preventable diseases, among other indicators. The top quartile comprises Connecticut, Hawaii, Iowa, Maine, Massachusetts, Minnesota, Nebraska, New Hampshire, North Dakota, Rhode Island, South Dakota, Vermont, and Wisconsin.

Ten of the 13 states in the lowest quartile—Alabama, Arkansas, Florida, Kentucky, Louisiana, Mississippi, Nevada, Oklahoma, Tennessee, and Texas—also ranked at the bottom on the previous 2007 report. Illinois, New Mexico, and North Carolina dropped into the lowest quartile since the last survey, while California, Georgia, and West Virginia moved up out of the last quartile in this most recent report. The lower-performing states had rates of uninsured adults and children that were double those in the top quartile.

The uninsured and those with low incomes tended to have poorer access to care and to receive a lower quality of care, Ms. Schoen said.

The report also reflected some bright spots: The quality of hospital care for heart attack, heart failure, pneumonia, and the prevention of surgical complications improved dramatically for all states, as did the quality of nursing home care. The Commonwealth Fund attributed the improvements to the increasing national efforts to measure and benchmark performance, including Medicare's Hospital Compare and Nursing Home Compare Web sites.

Conversely, data on ambulatory care quality is sorely lacking, Ms. Schoen said. From what can be gleaned, states' performance on preventive care stayed the same or declined. And poor coordination of care is resulting in continued high—and increasing—rates of hospital readmissions, according to the scorecard.

Ms. Davis touted the patient-centered medical home as a way to improve performance in preventive care, ambulatory care, and hospital readmissions. She said that 31 states are sponsoring medical home projects, and that the Commonwealth Fund is supporting efforts in Colorado, Idaho, Massachusetts, Oregon, and Pennsylvania to help safety net clinics become medical homes.

According to Ms. Davis and her colleagues, if the lower-performing states were helped to reach the levels of the higher-performing states, 29 million more people would be insured; 78,000 fewer adults and children would die prematurely each year from preventable conditions; 9 million more adults aged 50 years and older would receive recommended preventive care; and almost 800,000 more children would receive key vaccinations.

The organization also said that the nation could realize $5 billion in savings a year by avoiding preventable admissions and readmissions.

A continued wide disparity in access to and quality of care across the United States argues strongly for a national health reform plan, according to executives at the Commonwealth Fund, who released a state-by-state survey of 38 health indicators.

According to the Commonwealth Fund survey, there is a fivefold difference in performance on the indicators between the highest-ranked states and the lowest. "The differences we see among the states translate to real lives and real dollars," Karen Davis, president of the Commonwealth Fund, said at a press conference. "In the richest country in the world, there is no justification for any state to be far below the best state for quality and access to health care."

Health reform legislation under consideration in Congress would go a long way toward improving access and coverage, and that would increase quality overall, Ms. Davis said.

This is the second time the nonprofit group has taken a microscopic look at issues of cost, quality, and access in each state and the District of Columbia. Since the first report card in 2007, the number of uninsured adults has risen—and this survey was done on the eve of the recession, so the "worst is yet to come," according to Cathy Schoen, senior vice president of the Commonwealth Fund.

Coverage for children, however, has remained steady or improved, thanks to the federally supported Children's Health Insurance Program (CHIP), Ms. Schoen said.

States in the top quartile have been top performers in previous scorecards and have higher rates of insured adults and children, better access to primary care, and lower mortality from preventable diseases, among other indicators. The top quartile comprises Connecticut, Hawaii, Iowa, Maine, Massachusetts, Minnesota, Nebraska, New Hampshire, North Dakota, Rhode Island, South Dakota, Vermont, and Wisconsin.

Ten of the 13 states in the lowest quartile—Alabama, Arkansas, Florida, Kentucky, Louisiana, Mississippi, Nevada, Oklahoma, Tennessee, and Texas—also ranked at the bottom on the previous 2007 report. Illinois, New Mexico, and North Carolina dropped into the lowest quartile since the last survey, while California, Georgia, and West Virginia moved up out of the last quartile in this most recent report. The lower-performing states had rates of uninsured adults and children that were double those in the top quartile.

The uninsured and those with low incomes tended to have poorer access to care and to receive a lower quality of care, Ms. Schoen said.

The report also reflected some bright spots: The quality of hospital care for heart attack, heart failure, pneumonia, and the prevention of surgical complications improved dramatically for all states, as did the quality of nursing home care. The Commonwealth Fund attributed the improvements to the increasing national efforts to measure and benchmark performance, including Medicare's Hospital Compare and Nursing Home Compare Web sites.

Conversely, data on ambulatory care quality is sorely lacking, Ms. Schoen said. From what can be gleaned, states' performance on preventive care stayed the same or declined. And poor coordination of care is resulting in continued high—and increasing—rates of hospital readmissions, according to the scorecard.

Ms. Davis touted the patient-centered medical home as a way to improve performance in preventive care, ambulatory care, and hospital readmissions. She said that 31 states are sponsoring medical home projects, and that the Commonwealth Fund is supporting efforts in Colorado, Idaho, Massachusetts, Oregon, and Pennsylvania to help safety net clinics become medical homes.

According to Ms. Davis and her colleagues, if the lower-performing states were helped to reach the levels of the higher-performing states, 29 million more people would be insured; 78,000 fewer adults and children would die prematurely each year from preventable conditions; 9 million more adults aged 50 years and older would receive recommended preventive care; and almost 800,000 more children would receive key vaccinations.

The organization also said that the nation could realize $5 billion in savings a year by avoiding preventable admissions and readmissions.

A continued wide disparity in access to and quality of care across the United States argues strongly for a national health reform plan, according to executives at the Commonwealth Fund, who released a state-by-state survey of 38 health indicators.

According to the Commonwealth Fund survey, there is a fivefold difference in performance on the indicators between the highest-ranked states and the lowest. "The differences we see among the states translate to real lives and real dollars," Karen Davis, president of the Commonwealth Fund, said at a press conference. "In the richest country in the world, there is no justification for any state to be far below the best state for quality and access to health care."

Health reform legislation under consideration in Congress would go a long way toward improving access and coverage, and that would increase quality overall, Ms. Davis said.

This is the second time the nonprofit group has taken a microscopic look at issues of cost, quality, and access in each state and the District of Columbia. Since the first report card in 2007, the number of uninsured adults has risen—and this survey was done on the eve of the recession, so the "worst is yet to come," according to Cathy Schoen, senior vice president of the Commonwealth Fund.

Coverage for children, however, has remained steady or improved, thanks to the federally supported Children's Health Insurance Program (CHIP), Ms. Schoen said.

States in the top quartile have been top performers in previous scorecards and have higher rates of insured adults and children, better access to primary care, and lower mortality from preventable diseases, among other indicators. The top quartile comprises Connecticut, Hawaii, Iowa, Maine, Massachusetts, Minnesota, Nebraska, New Hampshire, North Dakota, Rhode Island, South Dakota, Vermont, and Wisconsin.

Ten of the 13 states in the lowest quartile—Alabama, Arkansas, Florida, Kentucky, Louisiana, Mississippi, Nevada, Oklahoma, Tennessee, and Texas—also ranked at the bottom on the previous 2007 report. Illinois, New Mexico, and North Carolina dropped into the lowest quartile since the last survey, while California, Georgia, and West Virginia moved up out of the last quartile in this most recent report. The lower-performing states had rates of uninsured adults and children that were double those in the top quartile.

The uninsured and those with low incomes tended to have poorer access to care and to receive a lower quality of care, Ms. Schoen said.

The report also reflected some bright spots: The quality of hospital care for heart attack, heart failure, pneumonia, and the prevention of surgical complications improved dramatically for all states, as did the quality of nursing home care. The Commonwealth Fund attributed the improvements to the increasing national efforts to measure and benchmark performance, including Medicare's Hospital Compare and Nursing Home Compare Web sites.

Conversely, data on ambulatory care quality is sorely lacking, Ms. Schoen said. From what can be gleaned, states' performance on preventive care stayed the same or declined. And poor coordination of care is resulting in continued high—and increasing—rates of hospital readmissions, according to the scorecard.

Ms. Davis touted the patient-centered medical home as a way to improve performance in preventive care, ambulatory care, and hospital readmissions. She said that 31 states are sponsoring medical home projects, and that the Commonwealth Fund is supporting efforts in Colorado, Idaho, Massachusetts, Oregon, and Pennsylvania to help safety net clinics become medical homes.

According to Ms. Davis and her colleagues, if the lower-performing states were helped to reach the levels of the higher-performing states, 29 million more people would be insured; 78,000 fewer adults and children would die prematurely each year from preventable conditions; 9 million more adults aged 50 years and older would receive recommended preventive care; and almost 800,000 more children would receive key vaccinations.

The organization also said that the nation could realize $5 billion in savings a year by avoiding preventable admissions and readmissions.

The Food and Drug Administration said that it had determined that electronic cigarettes marketed by two manufacturers contained carcinogens, varying amounts of nicotine, and impurities such as diethylene glycol.

Since July 2008, the agency has been seizing shipments of the so-called “e-cigarettes” at the United States border and analyzing them. It has determined that the e-cigarettes meet the legal definition of a drug and a device, and therefore, are being illegally sold. However, the FDA has not, as of yet, taken any additional action, agency officials said in a briefing with reporters. The agency is considering additional steps, said Michael Levy, division director of the Office of Compliance at the FDA's Center for Drug Evaluation and Research.

The FDA held the briefing to alert the public to its laboratory findings and express concern that the products may be used by children as a gateway to cigarettes, said Dr. Joshua Sharfstein, principal deputy commissioner.

Battery powered, electronic cigarettes vaporize chemicals contained in a cartridge; users inhale the vapor.

The FDA analyzed 19 cartridges made by Smoking Everywhere and NJOY. The agency found detectable levels of tobacco-specific nitrosamines—which are known human carcinogens—in half the samples. Most samples also contained impurities known to be toxic to humans, such as anabasine, myosmine, and beta-nicotyrine. One cartridge contained 1% diethylene glycol, a toxic component of antifreeze. In another instance, cartridges claiming to have no nicotine had low levels of the substance, and the amount of nicotine per puff varied widely.

Generally, the e-cigarettes are marketed as smoking cessation aids or smoke-free alternatives to cigarettes, said agency officials. The products can be purchased online and at retailers, including shopping malls, where children congregate, said Dr. Jonathan Winickoff, chairman of the American Academy of Pediatrics Tobacco Consortium, who participated in the briefing.

In addition, the cartridges come in flavors such as bubble gum, mint, chocolate, and chocolate chip, he noted. Such flavors are particularly appealing to children and novice smokers.

“Once you've smoked an e-cigarette and are nicotine dependent, the leap to a regular cigarette may not be as great,” said Dr. Winickoff.”

For now, the e-cigarettes will remain on the market. Sunrise, Fla.–based Smoking Everywhere has sued the FDA, claiming it does not have jurisdiction over its products. The agency has argued that it has the power to regulate the e-cigarettes in a manner similar to smoking cessation products.

The Food and Drug Administration said that it had determined that electronic cigarettes marketed by two manufacturers contained carcinogens, varying amounts of nicotine, and impurities such as diethylene glycol.

Since July 2008, the agency has been seizing shipments of the so-called “e-cigarettes” at the United States border and analyzing them. It has determined that the e-cigarettes meet the legal definition of a drug and a device, and therefore, are being illegally sold. However, the FDA has not, as of yet, taken any additional action, agency officials said in a briefing with reporters. The agency is considering additional steps, said Michael Levy, division director of the Office of Compliance at the FDA's Center for Drug Evaluation and Research.

The FDA held the briefing to alert the public to its laboratory findings and express concern that the products may be used by children as a gateway to cigarettes, said Dr. Joshua Sharfstein, principal deputy commissioner.

Battery powered, electronic cigarettes vaporize chemicals contained in a cartridge; users inhale the vapor.

The FDA analyzed 19 cartridges made by Smoking Everywhere and NJOY. The agency found detectable levels of tobacco-specific nitrosamines—which are known human carcinogens—in half the samples. Most samples also contained impurities known to be toxic to humans, such as anabasine, myosmine, and beta-nicotyrine. One cartridge contained 1% diethylene glycol, a toxic component of antifreeze. In another instance, cartridges claiming to have no nicotine had low levels of the substance, and the amount of nicotine per puff varied widely.

Generally, the e-cigarettes are marketed as smoking cessation aids or smoke-free alternatives to cigarettes, said agency officials. The products can be purchased online and at retailers, including shopping malls, where children congregate, said Dr. Jonathan Winickoff, chairman of the American Academy of Pediatrics Tobacco Consortium, who participated in the briefing.

In addition, the cartridges come in flavors such as bubble gum, mint, chocolate, and chocolate chip, he noted. Such flavors are particularly appealing to children and novice smokers.

“Once you've smoked an e-cigarette and are nicotine dependent, the leap to a regular cigarette may not be as great,” said Dr. Winickoff.”

For now, the e-cigarettes will remain on the market. Sunrise, Fla.–based Smoking Everywhere has sued the FDA, claiming it does not have jurisdiction over its products. The agency has argued that it has the power to regulate the e-cigarettes in a manner similar to smoking cessation products.

The Food and Drug Administration said that it had determined that electronic cigarettes marketed by two manufacturers contained carcinogens, varying amounts of nicotine, and impurities such as diethylene glycol.

Since July 2008, the agency has been seizing shipments of the so-called “e-cigarettes” at the United States border and analyzing them. It has determined that the e-cigarettes meet the legal definition of a drug and a device, and therefore, are being illegally sold. However, the FDA has not, as of yet, taken any additional action, agency officials said in a briefing with reporters. The agency is considering additional steps, said Michael Levy, division director of the Office of Compliance at the FDA's Center for Drug Evaluation and Research.

The FDA held the briefing to alert the public to its laboratory findings and express concern that the products may be used by children as a gateway to cigarettes, said Dr. Joshua Sharfstein, principal deputy commissioner.

Battery powered, electronic cigarettes vaporize chemicals contained in a cartridge; users inhale the vapor.

The FDA analyzed 19 cartridges made by Smoking Everywhere and NJOY. The agency found detectable levels of tobacco-specific nitrosamines—which are known human carcinogens—in half the samples. Most samples also contained impurities known to be toxic to humans, such as anabasine, myosmine, and beta-nicotyrine. One cartridge contained 1% diethylene glycol, a toxic component of antifreeze. In another instance, cartridges claiming to have no nicotine had low levels of the substance, and the amount of nicotine per puff varied widely.

Generally, the e-cigarettes are marketed as smoking cessation aids or smoke-free alternatives to cigarettes, said agency officials. The products can be purchased online and at retailers, including shopping malls, where children congregate, said Dr. Jonathan Winickoff, chairman of the American Academy of Pediatrics Tobacco Consortium, who participated in the briefing.

In addition, the cartridges come in flavors such as bubble gum, mint, chocolate, and chocolate chip, he noted. Such flavors are particularly appealing to children and novice smokers.

“Once you've smoked an e-cigarette and are nicotine dependent, the leap to a regular cigarette may not be as great,” said Dr. Winickoff.”

For now, the e-cigarettes will remain on the market. Sunrise, Fla.–based Smoking Everywhere has sued the FDA, claiming it does not have jurisdiction over its products. The agency has argued that it has the power to regulate the e-cigarettes in a manner similar to smoking cessation products.

The Food and Drug Administration approved guanfacine (Intuniv) for treatment of attention-deficit/hyperactivity disorder for children and adolescents aged 6-17 years.

The extended-release form of the drug is a selective alpha-2A adrenergic receptor agonist and was first approved for the treatment of hypertension in 2002, and for ADHD in 2007. But its use was limited by its short half-life. The once-daily version will be available in four dosages: 1 mg, 2 mg, 3 mg, and 4 mg.

Unlike many other drugs for ADHD, Intuniv is not a controlled substance. According to manufacturer Shire Pharmaceuticals, Intuniv “has no known potential for abuse or dependence.” The company said that it expected the drug to be available in November.

The FDA sent Shire an “approvable” letter in January 2008, but in early August, the company was told by the agency that it still was not in agreement on the final labeling for the extended-release form of guanfacine.

With approval, Shire said that Intuniv's labeling will contraindicate use in patients with a history of hypersensitivity to guanfacine or any of its active ingredients. Because hypotension, bradycardia, and syncope were all observed in clinical trials, the drug should be used with caution in patients who have experienced any of those conditions previously, or who may be predisposed to syncope, or who are taking antihypertensives.

Labeling will also note that sedation and somnolence were observed in trials.

The mechanism of action is unknown, but, according to statement from Shire, the drug seems to stimulate the postsynaptic alpha-2A receptors, which are “thought to strengthen working memory, reduce susceptibility to distraction, improve attention regulation, improve behavioral inhibition, and enhance impulse control.”

The Food and Drug Administration approved guanfacine (Intuniv) for treatment of attention-deficit/hyperactivity disorder for children and adolescents aged 6-17 years.

The extended-release form of the drug is a selective alpha-2A adrenergic receptor agonist and was first approved for the treatment of hypertension in 2002, and for ADHD in 2007. But its use was limited by its short half-life. The once-daily version will be available in four dosages: 1 mg, 2 mg, 3 mg, and 4 mg.

Unlike many other drugs for ADHD, Intuniv is not a controlled substance. According to manufacturer Shire Pharmaceuticals, Intuniv “has no known potential for abuse or dependence.” The company said that it expected the drug to be available in November.

The FDA sent Shire an “approvable” letter in January 2008, but in early August, the company was told by the agency that it still was not in agreement on the final labeling for the extended-release form of guanfacine.

With approval, Shire said that Intuniv's labeling will contraindicate use in patients with a history of hypersensitivity to guanfacine or any of its active ingredients. Because hypotension, bradycardia, and syncope were all observed in clinical trials, the drug should be used with caution in patients who have experienced any of those conditions previously, or who may be predisposed to syncope, or who are taking antihypertensives.

Labeling will also note that sedation and somnolence were observed in trials.

The mechanism of action is unknown, but, according to statement from Shire, the drug seems to stimulate the postsynaptic alpha-2A receptors, which are “thought to strengthen working memory, reduce susceptibility to distraction, improve attention regulation, improve behavioral inhibition, and enhance impulse control.”

The Food and Drug Administration approved guanfacine (Intuniv) for treatment of attention-deficit/hyperactivity disorder for children and adolescents aged 6-17 years.

The extended-release form of the drug is a selective alpha-2A adrenergic receptor agonist and was first approved for the treatment of hypertension in 2002, and for ADHD in 2007. But its use was limited by its short half-life. The once-daily version will be available in four dosages: 1 mg, 2 mg, 3 mg, and 4 mg.

Unlike many other drugs for ADHD, Intuniv is not a controlled substance. According to manufacturer Shire Pharmaceuticals, Intuniv “has no known potential for abuse or dependence.” The company said that it expected the drug to be available in November.

The FDA sent Shire an “approvable” letter in January 2008, but in early August, the company was told by the agency that it still was not in agreement on the final labeling for the extended-release form of guanfacine.

With approval, Shire said that Intuniv's labeling will contraindicate use in patients with a history of hypersensitivity to guanfacine or any of its active ingredients. Because hypotension, bradycardia, and syncope were all observed in clinical trials, the drug should be used with caution in patients who have experienced any of those conditions previously, or who may be predisposed to syncope, or who are taking antihypertensives.

Labeling will also note that sedation and somnolence were observed in trials.

The mechanism of action is unknown, but, according to statement from Shire, the drug seems to stimulate the postsynaptic alpha-2A receptors, which are “thought to strengthen working memory, reduce susceptibility to distraction, improve attention regulation, improve behavioral inhibition, and enhance impulse control.”

FDA Cites Tri-Luma Promotions

The FDA has warned Galderma Laboratories that its promotions of Tri-Luma “recommend or suggest uses … that have not been approved by FDA.” The Tri-Luma promotions also omit and minimize risk information, said the FDA's Division of Drug Marketing, Advertising, and Communications in its 10-page letter to the company. The combination of fluocinolone acetonide, hydroquinone, and tretinoin is approved for short-term treatment of moderate to severe melasma. The company has been promoting Tri-Luma for use with glycolic acid peels, the agency said, calling it “concerning, from a safety perspective.” The materials also suggest that the drug can be used in a broad range of patients for up to a year, the FDA said. Such representations are “extremely concerning from a public health perspective” and should be stopped, said the letter.

Agency Also Warns on Aczone

A journal ad for Aczone (dapsone) Gel 5% “grossly overstates” the drug's efficacy and leaves out important risk information, the FDA advertising and marketing division told drugmaker Allergan. The company is implying that Aczone substantially and quickly reduces acne lesions, when in fact, the study cited in the ad found the drug's advantage over placebo “not even nominally statistically significant,” the agency said in a letter. The journal ad “presents only the study's most favorable result,” said the FDA, which asked Allergan to stop running the ad.

Groups: Nano Is Sunscreen No-No

The Friends of the Earth, Consumers Union, and the International Center for Technology Assessment are warning of the dangers of nanomaterials in sunscreens. Nanoparticles, used to make titanium dioxide and zinc oxide appear clear on the skin, have not been adequately tested for safety, claim the groups. They assert that the limited data available, in fact, show that nanoparticles are more likely to enter the lungs and pass through cell membranes than normal materials are. A 2006 study found that some nanoparticles in titanium dioxide are toxic to certain marine organisms vital to the ecosystem. Consumers Union had previously found in its own testing that nanoparticles don't boost sun protection or otherwise perform better than other sunscreens. The International Center for Technology Assessment pointed out that there is no approval process for nanomaterials in any product and that labels aren't required to reveal their presence. The report is available at

www.foe.org/nano-sunscreens

Device Director Resigns

Dr. Daniel Schultz, the beleaguered director of the FDA's Center for Devices and Radiological Health, has resigned from the agency. According to The Gray Sheet (a sister publication to

More Faux-Botox Arrests

In yet another case involving counterfeit Botox, a Washington state beauty salon owner was arrested in late August on charges of having injected patients with fake botulinum toxin and fake Restylane (hyaluronic acid). The injections began in 2004 and continued despite the fact that the woman arrested was issued a cease and desist order in 2006. One woman had to seek care from a dermatologist after the supposed Restylane was injected into her face. According to the investigators, the vial had Chinese characters on it. Another woman had to be treated by a plastic surgeon. If convicted, the salon owner faces from 3 to 15 years in prison. The arrest was the result of a joint investigation between the Food and Drug Administration Office of Criminal Investigations and the Immigration and Customs Enforcement Agency.

HHS Issues New HIPAA Rules

The federal government is requiring physicians and other entities covered under the Health Insurance Portability and Accountability Act to notify individuals when their health information has been breached. Under the rule going into effect this month, physicians will have up to 60 days to notify a patient when that person's health information has been accessed by an unauthorized party. If the breach involves more than 500 individuals, the Department of Health and Human Services and at least one major media outlet must be notified. “These protections will be a cornerstone of maintaining consumer trust as we move forward with meaningful use of electronic health records and electronic exchange of health information,” said Robinsue Frohboese, acting director of the Office of Civil Rights at HHS. But there are exceptions to the rule: Notifications are not necessary if the information that was disclosed is unlikely to be retained. For example, if a nurse gives a patient the wrong discharge papers but quickly takes them back, it's reasonable to assume that the patient could not have retained that protected information, according to HHS. More information is available at

www.hhs.gov/ocr/privacy

Supplement Maker Fined $70 M

In a case brought by the Federal Trade Commission, a marketing group that used infomercials to tout calcium and herbal supplements as effective treatments for cancer, Parkinson's disease, heart disease, and autoimmune conditions has been ordered to pay about $70 million in consumer refunds. Last year, the U.S. District Court for the District of Massachusetts ruled that the companies and individuals involved in marketing the supplements had falsely represented their safety and efficacy. Judge George O'Toole considered potential financial penalties separately, and has now ordered the restitution in order to strip from the defendants all profits derived from the supplement sales. He also issued injunctions to prevent the defendants from making similar claims about other products.

FDA Cites Tri-Luma Promotions

The FDA has warned Galderma Laboratories that its promotions of Tri-Luma “recommend or suggest uses … that have not been approved by FDA.” The Tri-Luma promotions also omit and minimize risk information, said the FDA's Division of Drug Marketing, Advertising, and Communications in its 10-page letter to the company. The combination of fluocinolone acetonide, hydroquinone, and tretinoin is approved for short-term treatment of moderate to severe melasma. The company has been promoting Tri-Luma for use with glycolic acid peels, the agency said, calling it “concerning, from a safety perspective.” The materials also suggest that the drug can be used in a broad range of patients for up to a year, the FDA said. Such representations are “extremely concerning from a public health perspective” and should be stopped, said the letter.

Agency Also Warns on Aczone

A journal ad for Aczone (dapsone) Gel 5% “grossly overstates” the drug's efficacy and leaves out important risk information, the FDA advertising and marketing division told drugmaker Allergan. The company is implying that Aczone substantially and quickly reduces acne lesions, when in fact, the study cited in the ad found the drug's advantage over placebo “not even nominally statistically significant,” the agency said in a letter. The journal ad “presents only the study's most favorable result,” said the FDA, which asked Allergan to stop running the ad.

Groups: Nano Is Sunscreen No-No

The Friends of the Earth, Consumers Union, and the International Center for Technology Assessment are warning of the dangers of nanomaterials in sunscreens. Nanoparticles, used to make titanium dioxide and zinc oxide appear clear on the skin, have not been adequately tested for safety, claim the groups. They assert that the limited data available, in fact, show that nanoparticles are more likely to enter the lungs and pass through cell membranes than normal materials are. A 2006 study found that some nanoparticles in titanium dioxide are toxic to certain marine organisms vital to the ecosystem. Consumers Union had previously found in its own testing that nanoparticles don't boost sun protection or otherwise perform better than other sunscreens. The International Center for Technology Assessment pointed out that there is no approval process for nanomaterials in any product and that labels aren't required to reveal their presence. The report is available at

www.foe.org/nano-sunscreens

Device Director Resigns

Dr. Daniel Schultz, the beleaguered director of the FDA's Center for Devices and Radiological Health, has resigned from the agency. According to The Gray Sheet (a sister publication to

More Faux-Botox Arrests

In yet another case involving counterfeit Botox, a Washington state beauty salon owner was arrested in late August on charges of having injected patients with fake botulinum toxin and fake Restylane (hyaluronic acid). The injections began in 2004 and continued despite the fact that the woman arrested was issued a cease and desist order in 2006. One woman had to seek care from a dermatologist after the supposed Restylane was injected into her face. According to the investigators, the vial had Chinese characters on it. Another woman had to be treated by a plastic surgeon. If convicted, the salon owner faces from 3 to 15 years in prison. The arrest was the result of a joint investigation between the Food and Drug Administration Office of Criminal Investigations and the Immigration and Customs Enforcement Agency.

HHS Issues New HIPAA Rules

The federal government is requiring physicians and other entities covered under the Health Insurance Portability and Accountability Act to notify individuals when their health information has been breached. Under the rule going into effect this month, physicians will have up to 60 days to notify a patient when that person's health information has been accessed by an unauthorized party. If the breach involves more than 500 individuals, the Department of Health and Human Services and at least one major media outlet must be notified. “These protections will be a cornerstone of maintaining consumer trust as we move forward with meaningful use of electronic health records and electronic exchange of health information,” said Robinsue Frohboese, acting director of the Office of Civil Rights at HHS. But there are exceptions to the rule: Notifications are not necessary if the information that was disclosed is unlikely to be retained. For example, if a nurse gives a patient the wrong discharge papers but quickly takes them back, it's reasonable to assume that the patient could not have retained that protected information, according to HHS. More information is available at

www.hhs.gov/ocr/privacy

Supplement Maker Fined $70 M

In a case brought by the Federal Trade Commission, a marketing group that used infomercials to tout calcium and herbal supplements as effective treatments for cancer, Parkinson's disease, heart disease, and autoimmune conditions has been ordered to pay about $70 million in consumer refunds. Last year, the U.S. District Court for the District of Massachusetts ruled that the companies and individuals involved in marketing the supplements had falsely represented their safety and efficacy. Judge George O'Toole considered potential financial penalties separately, and has now ordered the restitution in order to strip from the defendants all profits derived from the supplement sales. He also issued injunctions to prevent the defendants from making similar claims about other products.

FDA Cites Tri-Luma Promotions

The FDA has warned Galderma Laboratories that its promotions of Tri-Luma “recommend or suggest uses … that have not been approved by FDA.” The Tri-Luma promotions also omit and minimize risk information, said the FDA's Division of Drug Marketing, Advertising, and Communications in its 10-page letter to the company. The combination of fluocinolone acetonide, hydroquinone, and tretinoin is approved for short-term treatment of moderate to severe melasma. The company has been promoting Tri-Luma for use with glycolic acid peels, the agency said, calling it “concerning, from a safety perspective.” The materials also suggest that the drug can be used in a broad range of patients for up to a year, the FDA said. Such representations are “extremely concerning from a public health perspective” and should be stopped, said the letter.

Agency Also Warns on Aczone

A journal ad for Aczone (dapsone) Gel 5% “grossly overstates” the drug's efficacy and leaves out important risk information, the FDA advertising and marketing division told drugmaker Allergan. The company is implying that Aczone substantially and quickly reduces acne lesions, when in fact, the study cited in the ad found the drug's advantage over placebo “not even nominally statistically significant,” the agency said in a letter. The journal ad “presents only the study's most favorable result,” said the FDA, which asked Allergan to stop running the ad.

Groups: Nano Is Sunscreen No-No

The Friends of the Earth, Consumers Union, and the International Center for Technology Assessment are warning of the dangers of nanomaterials in sunscreens. Nanoparticles, used to make titanium dioxide and zinc oxide appear clear on the skin, have not been adequately tested for safety, claim the groups. They assert that the limited data available, in fact, show that nanoparticles are more likely to enter the lungs and pass through cell membranes than normal materials are. A 2006 study found that some nanoparticles in titanium dioxide are toxic to certain marine organisms vital to the ecosystem. Consumers Union had previously found in its own testing that nanoparticles don't boost sun protection or otherwise perform better than other sunscreens. The International Center for Technology Assessment pointed out that there is no approval process for nanomaterials in any product and that labels aren't required to reveal their presence. The report is available at

www.foe.org/nano-sunscreens

Device Director Resigns

Dr. Daniel Schultz, the beleaguered director of the FDA's Center for Devices and Radiological Health, has resigned from the agency. According to The Gray Sheet (a sister publication to

More Faux-Botox Arrests

In yet another case involving counterfeit Botox, a Washington state beauty salon owner was arrested in late August on charges of having injected patients with fake botulinum toxin and fake Restylane (hyaluronic acid). The injections began in 2004 and continued despite the fact that the woman arrested was issued a cease and desist order in 2006. One woman had to seek care from a dermatologist after the supposed Restylane was injected into her face. According to the investigators, the vial had Chinese characters on it. Another woman had to be treated by a plastic surgeon. If convicted, the salon owner faces from 3 to 15 years in prison. The arrest was the result of a joint investigation between the Food and Drug Administration Office of Criminal Investigations and the Immigration and Customs Enforcement Agency.

HHS Issues New HIPAA Rules

The federal government is requiring physicians and other entities covered under the Health Insurance Portability and Accountability Act to notify individuals when their health information has been breached. Under the rule going into effect this month, physicians will have up to 60 days to notify a patient when that person's health information has been accessed by an unauthorized party. If the breach involves more than 500 individuals, the Department of Health and Human Services and at least one major media outlet must be notified. “These protections will be a cornerstone of maintaining consumer trust as we move forward with meaningful use of electronic health records and electronic exchange of health information,” said Robinsue Frohboese, acting director of the Office of Civil Rights at HHS. But there are exceptions to the rule: Notifications are not necessary if the information that was disclosed is unlikely to be retained. For example, if a nurse gives a patient the wrong discharge papers but quickly takes them back, it's reasonable to assume that the patient could not have retained that protected information, according to HHS. More information is available at

www.hhs.gov/ocr/privacy

Supplement Maker Fined $70 M

In a case brought by the Federal Trade Commission, a marketing group that used infomercials to tout calcium and herbal supplements as effective treatments for cancer, Parkinson's disease, heart disease, and autoimmune conditions has been ordered to pay about $70 million in consumer refunds. Last year, the U.S. District Court for the District of Massachusetts ruled that the companies and individuals involved in marketing the supplements had falsely represented their safety and efficacy. Judge George O'Toole considered potential financial penalties separately, and has now ordered the restitution in order to strip from the defendants all profits derived from the supplement sales. He also issued injunctions to prevent the defendants from making similar claims about other products.

The hard work of health reform lies in front of Congress as it heads back to work after its 5-week summer recess.

Over the next 2 months, Democrats and Republicans will have to figure out what to pare off the long wish lists put together by House and Senate committees, and, more importantly, take on the politically distasteful task of determining how to pay for what remains.

That job is the province primarily of the Senate Finance Committee, which at press time had yet to weigh in with a reform proposal. Reportedly, the committee set a Sept. 15 deadline to complete its work.

The funding issue is thorny enough; achieving a bipartisan consensus is another hurdle, and Finance Committee Chairman Max Baucus (D-Mont.) seems more wedded to achieving that than the other committees with jurisdiction over health care.

Joe Antos, a scholar with the Washington-based American Enterprise Institute, said he expected Sen. Baucus to go to the mat to win a bipartisan agreement, largely because of his friendship with the committee's ranking minority member Sen. Chuck Grassley (R-Iowa). And that could push potential floor action in the House and Senate further into the fall, he said.

Republican lawmakers have sought to slow down the process. In a teleconference with reporters, Sen. John Cornyn (R-Texas), who sits on the Senate Finance Committee, called for “time to analyze what's in the bills, and analyze the cost and effectiveness.” Visits to their home districts allow legislators to “check back with the people who are going to have to live with whatever we come up with and certainly they're going to have to pay for it,” he said.

The public option has been one of the most controversial aspects of the proposals floated so far. Ron Pollack, executive director of the liberal advocacy group Families USA, said in an interview that the focus on the public option has overshadowed many provisions of proposed legislation that “are enormously important and are not anywhere near as controversial,” but that “are essential to health reform.”

Those provisions would help bring costs down and improve access to care through reforms of the insurance market, said Mr. Pollack. He expects the House to pass a “robust public plan option as part of its legislative package,” but said that the Senate is less likely to do so.

The administration also appeared to paint the insurance industry as the poster child for everything wrong with the current system. At the New Hampshire event, President Obama said that under reform, “insurance companies will be prohibited from denying coverage because of a person's medical history,” and that “they will not be able to water down your coverage when you need it.”

But the industry has fought back. “Health plans last year proposed health insurance reform to make sure that no one is denied coverage because of a pre-existing condition,” Karen Ignagni, CEO of America's Health Insurance Plans, said in a statement. “Our proposal includes new consumer protections and market rules to guarantee coverage for pre-existing conditions, discontinue basing premiums on a person's health status or gender, and get everyone covered through a personal coverage requirement.”

Mr. Antos said that taking on the insurance business might make for good public relations, but that “this tactic seems like an admission of defeat,” by the administration. If the White House makes a villain out of insurers now, it might make it difficult negotiate with the industry this fall, he said.

The insurers' cooperation might be necessary to meet the president's goal of having a deficit-neutral reform package. The White House has gotten promises from the pharmaceutical industry and hospitals to cut costs over the next decade, but physicians are looking for a raise from Medicare—or at least a guarantee that their fees won't be cut.

The substance of that final health reform package is far from clear.

The House and Senate plans differ (see chart); the addition of the Finance Committee's proposal, when it comes, is likely to widen the gap.

Mr. Pollack of Families USA noted with without bipartisan agreement, theSenate leadership will move forward without the Republicans and put the whole package to the floor for a vote, likely through the complicated reconciliation process. Under that procedural maneuver, only 51 votes are required for passage.

That scenario looks increasingly likely, according to Mr. Pollack. He said that Senate Republican leaders, including John Kyl (R-Ariz.) and Mitch McConnell (R-Ky.), “feel it's in the best interest of the Republican Party politically to defeat health care reform.”

Joyce Frieden and Mary Ellen Schneider contributed to this report.

ELSEVIER GLOBAL MEDICAL NEWS

The hard work of health reform lies in front of Congress as it heads back to work after its 5-week summer recess.

Over the next 2 months, Democrats and Republicans will have to figure out what to pare off the long wish lists put together by House and Senate committees, and, more importantly, take on the politically distasteful task of determining how to pay for what remains.

That job is the province primarily of the Senate Finance Committee, which at press time had yet to weigh in with a reform proposal. Reportedly, the committee set a Sept. 15 deadline to complete its work.

The funding issue is thorny enough; achieving a bipartisan consensus is another hurdle, and Finance Committee Chairman Max Baucus (D-Mont.) seems more wedded to achieving that than the other committees with jurisdiction over health care.

Joe Antos, a scholar with the Washington-based American Enterprise Institute, said he expected Sen. Baucus to go to the mat to win a bipartisan agreement, largely because of his friendship with the committee's ranking minority member Sen. Chuck Grassley (R-Iowa). And that could push potential floor action in the House and Senate further into the fall, he said.

Republican lawmakers have sought to slow down the process. In a teleconference with reporters, Sen. John Cornyn (R-Texas), who sits on the Senate Finance Committee, called for “time to analyze what's in the bills, and analyze the cost and effectiveness.” Visits to their home districts allow legislators to “check back with the people who are going to have to live with whatever we come up with and certainly they're going to have to pay for it,” he said.

The public option has been one of the most controversial aspects of the proposals floated so far. Ron Pollack, executive director of the liberal advocacy group Families USA, said in an interview that the focus on the public option has overshadowed many provisions of proposed legislation that “are enormously important and are not anywhere near as controversial,” but that “are essential to health reform.”

Those provisions would help bring costs down and improve access to care through reforms of the insurance market, said Mr. Pollack. He expects the House to pass a “robust public plan option as part of its legislative package,” but said that the Senate is less likely to do so.

The administration also appeared to paint the insurance industry as the poster child for everything wrong with the current system. At the New Hampshire event, President Obama said that under reform, “insurance companies will be prohibited from denying coverage because of a person's medical history,” and that “they will not be able to water down your coverage when you need it.”

But the industry has fought back. “Health plans last year proposed health insurance reform to make sure that no one is denied coverage because of a pre-existing condition,” Karen Ignagni, CEO of America's Health Insurance Plans, said in a statement. “Our proposal includes new consumer protections and market rules to guarantee coverage for pre-existing conditions, discontinue basing premiums on a person's health status or gender, and get everyone covered through a personal coverage requirement.”

Mr. Antos said that taking on the insurance business might make for good public relations, but that “this tactic seems like an admission of defeat,” by the administration. If the White House makes a villain out of insurers now, it might make it difficult negotiate with the industry this fall, he said.

The insurers' cooperation might be necessary to meet the president's goal of having a deficit-neutral reform package. The White House has gotten promises from the pharmaceutical industry and hospitals to cut costs over the next decade, but physicians are looking for a raise from Medicare—or at least a guarantee that their fees won't be cut.

The substance of that final health reform package is far from clear.

The House and Senate plans differ (see chart); the addition of the Finance Committee's proposal, when it comes, is likely to widen the gap.

Mr. Pollack of Families USA noted with without bipartisan agreement, theSenate leadership will move forward without the Republicans and put the whole package to the floor for a vote, likely through the complicated reconciliation process. Under that procedural maneuver, only 51 votes are required for passage.

That scenario looks increasingly likely, according to Mr. Pollack. He said that Senate Republican leaders, including John Kyl (R-Ariz.) and Mitch McConnell (R-Ky.), “feel it's in the best interest of the Republican Party politically to defeat health care reform.”

Joyce Frieden and Mary Ellen Schneider contributed to this report.

ELSEVIER GLOBAL MEDICAL NEWS

The hard work of health reform lies in front of Congress as it heads back to work after its 5-week summer recess.

Over the next 2 months, Democrats and Republicans will have to figure out what to pare off the long wish lists put together by House and Senate committees, and, more importantly, take on the politically distasteful task of determining how to pay for what remains.

That job is the province primarily of the Senate Finance Committee, which at press time had yet to weigh in with a reform proposal. Reportedly, the committee set a Sept. 15 deadline to complete its work.

The funding issue is thorny enough; achieving a bipartisan consensus is another hurdle, and Finance Committee Chairman Max Baucus (D-Mont.) seems more wedded to achieving that than the other committees with jurisdiction over health care.

Joe Antos, a scholar with the Washington-based American Enterprise Institute, said he expected Sen. Baucus to go to the mat to win a bipartisan agreement, largely because of his friendship with the committee's ranking minority member Sen. Chuck Grassley (R-Iowa). And that could push potential floor action in the House and Senate further into the fall, he said.

Republican lawmakers have sought to slow down the process. In a teleconference with reporters, Sen. John Cornyn (R-Texas), who sits on the Senate Finance Committee, called for “time to analyze what's in the bills, and analyze the cost and effectiveness.” Visits to their home districts allow legislators to “check back with the people who are going to have to live with whatever we come up with and certainly they're going to have to pay for it,” he said.

The public option has been one of the most controversial aspects of the proposals floated so far. Ron Pollack, executive director of the liberal advocacy group Families USA, said in an interview that the focus on the public option has overshadowed many provisions of proposed legislation that “are enormously important and are not anywhere near as controversial,” but that “are essential to health reform.”

Those provisions would help bring costs down and improve access to care through reforms of the insurance market, said Mr. Pollack. He expects the House to pass a “robust public plan option as part of its legislative package,” but said that the Senate is less likely to do so.

The administration also appeared to paint the insurance industry as the poster child for everything wrong with the current system. At the New Hampshire event, President Obama said that under reform, “insurance companies will be prohibited from denying coverage because of a person's medical history,” and that “they will not be able to water down your coverage when you need it.”

But the industry has fought back. “Health plans last year proposed health insurance reform to make sure that no one is denied coverage because of a pre-existing condition,” Karen Ignagni, CEO of America's Health Insurance Plans, said in a statement. “Our proposal includes new consumer protections and market rules to guarantee coverage for pre-existing conditions, discontinue basing premiums on a person's health status or gender, and get everyone covered through a personal coverage requirement.”

Mr. Antos said that taking on the insurance business might make for good public relations, but that “this tactic seems like an admission of defeat,” by the administration. If the White House makes a villain out of insurers now, it might make it difficult negotiate with the industry this fall, he said.

The insurers' cooperation might be necessary to meet the president's goal of having a deficit-neutral reform package. The White House has gotten promises from the pharmaceutical industry and hospitals to cut costs over the next decade, but physicians are looking for a raise from Medicare—or at least a guarantee that their fees won't be cut.

The substance of that final health reform package is far from clear.

The House and Senate plans differ (see chart); the addition of the Finance Committee's proposal, when it comes, is likely to widen the gap.

Mr. Pollack of Families USA noted with without bipartisan agreement, theSenate leadership will move forward without the Republicans and put the whole package to the floor for a vote, likely through the complicated reconciliation process. Under that procedural maneuver, only 51 votes are required for passage.

That scenario looks increasingly likely, according to Mr. Pollack. He said that Senate Republican leaders, including John Kyl (R-Ariz.) and Mitch McConnell (R-Ky.), “feel it's in the best interest of the Republican Party politically to defeat health care reform.”

Joyce Frieden and Mary Ellen Schneider contributed to this report.

ELSEVIER GLOBAL MEDICAL NEWS