Alicia Ault

Can't get enough Policy & Practice? Check out our new podcast each Monday. EGMNBLOG.WORDPRESS.COM

CMS Decision on Warfarin Test

The Centers for Medicare and Medicaid Services has decided that evidence does not support coverage of pharmacogenomic testing to predict warfarin responsiveness in Medicare beneficiaries. The diagnostics test for the presence of the CYP2C9 or VKORC1 alleles. However, the agency said it would make the test available through its Coverage With Evidence Development authority, meaning that testing will be covered by Medicare for patients who have not been previously tested for the alleles, have been on warfarin for less then 5 days when the test is ordered, and are enrolled in a prospective, randomized, controlled study that meets certain CMS criteria. Those studies will gather evidence on the testing, and may “provide an opportunity … to reconsider this determination,” the agency said in its decision memorandum.

FDA Device Chief Resigns

Dr. Daniel Schultz, the beleaguered director of the Food and Drug Administration's Center for Devices and Radiological Health, has resigned from the agency. According to The Gray Sheet (a sister publication to CARDIOLOGY NEWS), Dr. Schultz submitted his resignation to Dr. Margaret Hamburg, FDA Commissioner, after they agreed that his departure “would be in the best interest of the center and the agency.” The devices division has been under fire for about a year since whistleblowers from the division alleged corruption in a letter to Congress in 2008, and repeated many of the charges in a January letter to President Obama. At press time, no replacement had been named for Dr. Schultz, who had directed the center since 2004.

Texas Heart Screening Law Signed

Gov. Rick Perry (R) has signed a law requiring Texas insurers to pay for CT coronary artery calcium scans and carotid ultrasound scans that are used for atherosclerosis screening. The law took effect Sept. 1; insurers have to offer the coverage beginning with policies that renew in January, and must have the new coverage in place no later than September 2010. Insurers must pay a minimum of $200 per covered individual every 5 years, and the coverage applies only to men aged 45-76 years, and women aged 55-76 years.

Lilly Payment Data Now Public

Eli Lilly & Co. will publish how much it pays physicians and other health care professionals in consulting fees, honoraria, and the like. The drugmaker detailed the payments for the first quarter of 2009 at

www.lillyfacultyregistry.com

Bill Seeks Pay for Performance

A small bipartisan group of senators has cosponsored legislation that would pay a physician for work under part of Medicare only if a patient's health status improves. Sen. Ron Wyden (D-Ore.), Sen. John Cornyn (R-Tex.), and Sen. Tom Harkin (D-Iowa) offered the Take Back Your Health Act of 2009 (S. 1640) to create a new Medicare program based on “comprehensive lifestyle programs.” Such treatment plans would be designed by physicians specifically for each patient in the program. The plans can include nutritional therapy, exercise, medication management, care coordination, and tobacco-use cessation. Physicians wouldn't be paid if a patient were rehospitalized for a chronic illness accounted for in his or her plan. Sen. Wyden said in a statement that several trials of such a system, including those at Mutual of Omaha Insurance Co. and Highmark Blue Cross Blue Shield, have shown that comprehensive lifestyle programs can result in up to 50% reductions in medical costs.

Faulty Off-Label Prescribing?

A survey of 250 physicians—135 psychiatrists and 115 primary care doctors—found that many lack knowledge of certain drugs' approved indications. The study was published online in Pharmacoepidemiology and Drug Safety (doi: 10.1002/pds.1825). A large minority of physicians were mistaken that drugs were approved for uses they prescribed. For instance, 33% of respondents said they had prescribed lorazepam for chronic anxiety believing that it was approved for that, but the FDA warns against that use. Psychiatrists tended to be more accurate than primary care physicians.

Can't get enough Policy & Practice? Check out our new podcast each Monday. EGMNBLOG.WORDPRESS.COM

CMS Decision on Warfarin Test

The Centers for Medicare and Medicaid Services has decided that evidence does not support coverage of pharmacogenomic testing to predict warfarin responsiveness in Medicare beneficiaries. The diagnostics test for the presence of the CYP2C9 or VKORC1 alleles. However, the agency said it would make the test available through its Coverage With Evidence Development authority, meaning that testing will be covered by Medicare for patients who have not been previously tested for the alleles, have been on warfarin for less then 5 days when the test is ordered, and are enrolled in a prospective, randomized, controlled study that meets certain CMS criteria. Those studies will gather evidence on the testing, and may “provide an opportunity … to reconsider this determination,” the agency said in its decision memorandum.

FDA Device Chief Resigns

Dr. Daniel Schultz, the beleaguered director of the Food and Drug Administration's Center for Devices and Radiological Health, has resigned from the agency. According to The Gray Sheet (a sister publication to CARDIOLOGY NEWS), Dr. Schultz submitted his resignation to Dr. Margaret Hamburg, FDA Commissioner, after they agreed that his departure “would be in the best interest of the center and the agency.” The devices division has been under fire for about a year since whistleblowers from the division alleged corruption in a letter to Congress in 2008, and repeated many of the charges in a January letter to President Obama. At press time, no replacement had been named for Dr. Schultz, who had directed the center since 2004.

Texas Heart Screening Law Signed

Gov. Rick Perry (R) has signed a law requiring Texas insurers to pay for CT coronary artery calcium scans and carotid ultrasound scans that are used for atherosclerosis screening. The law took effect Sept. 1; insurers have to offer the coverage beginning with policies that renew in January, and must have the new coverage in place no later than September 2010. Insurers must pay a minimum of $200 per covered individual every 5 years, and the coverage applies only to men aged 45-76 years, and women aged 55-76 years.

Lilly Payment Data Now Public

Eli Lilly & Co. will publish how much it pays physicians and other health care professionals in consulting fees, honoraria, and the like. The drugmaker detailed the payments for the first quarter of 2009 at

www.lillyfacultyregistry.com

Bill Seeks Pay for Performance

A small bipartisan group of senators has cosponsored legislation that would pay a physician for work under part of Medicare only if a patient's health status improves. Sen. Ron Wyden (D-Ore.), Sen. John Cornyn (R-Tex.), and Sen. Tom Harkin (D-Iowa) offered the Take Back Your Health Act of 2009 (S. 1640) to create a new Medicare program based on “comprehensive lifestyle programs.” Such treatment plans would be designed by physicians specifically for each patient in the program. The plans can include nutritional therapy, exercise, medication management, care coordination, and tobacco-use cessation. Physicians wouldn't be paid if a patient were rehospitalized for a chronic illness accounted for in his or her plan. Sen. Wyden said in a statement that several trials of such a system, including those at Mutual of Omaha Insurance Co. and Highmark Blue Cross Blue Shield, have shown that comprehensive lifestyle programs can result in up to 50% reductions in medical costs.

Faulty Off-Label Prescribing?

A survey of 250 physicians—135 psychiatrists and 115 primary care doctors—found that many lack knowledge of certain drugs' approved indications. The study was published online in Pharmacoepidemiology and Drug Safety (doi: 10.1002/pds.1825). A large minority of physicians were mistaken that drugs were approved for uses they prescribed. For instance, 33% of respondents said they had prescribed lorazepam for chronic anxiety believing that it was approved for that, but the FDA warns against that use. Psychiatrists tended to be more accurate than primary care physicians.

Can't get enough Policy & Practice? Check out our new podcast each Monday. EGMNBLOG.WORDPRESS.COM

CMS Decision on Warfarin Test

The Centers for Medicare and Medicaid Services has decided that evidence does not support coverage of pharmacogenomic testing to predict warfarin responsiveness in Medicare beneficiaries. The diagnostics test for the presence of the CYP2C9 or VKORC1 alleles. However, the agency said it would make the test available through its Coverage With Evidence Development authority, meaning that testing will be covered by Medicare for patients who have not been previously tested for the alleles, have been on warfarin for less then 5 days when the test is ordered, and are enrolled in a prospective, randomized, controlled study that meets certain CMS criteria. Those studies will gather evidence on the testing, and may “provide an opportunity … to reconsider this determination,” the agency said in its decision memorandum.

FDA Device Chief Resigns

Dr. Daniel Schultz, the beleaguered director of the Food and Drug Administration's Center for Devices and Radiological Health, has resigned from the agency. According to The Gray Sheet (a sister publication to CARDIOLOGY NEWS), Dr. Schultz submitted his resignation to Dr. Margaret Hamburg, FDA Commissioner, after they agreed that his departure “would be in the best interest of the center and the agency.” The devices division has been under fire for about a year since whistleblowers from the division alleged corruption in a letter to Congress in 2008, and repeated many of the charges in a January letter to President Obama. At press time, no replacement had been named for Dr. Schultz, who had directed the center since 2004.

Texas Heart Screening Law Signed

Gov. Rick Perry (R) has signed a law requiring Texas insurers to pay for CT coronary artery calcium scans and carotid ultrasound scans that are used for atherosclerosis screening. The law took effect Sept. 1; insurers have to offer the coverage beginning with policies that renew in January, and must have the new coverage in place no later than September 2010. Insurers must pay a minimum of $200 per covered individual every 5 years, and the coverage applies only to men aged 45-76 years, and women aged 55-76 years.

Lilly Payment Data Now Public

Eli Lilly & Co. will publish how much it pays physicians and other health care professionals in consulting fees, honoraria, and the like. The drugmaker detailed the payments for the first quarter of 2009 at

www.lillyfacultyregistry.com

Bill Seeks Pay for Performance

A small bipartisan group of senators has cosponsored legislation that would pay a physician for work under part of Medicare only if a patient's health status improves. Sen. Ron Wyden (D-Ore.), Sen. John Cornyn (R-Tex.), and Sen. Tom Harkin (D-Iowa) offered the Take Back Your Health Act of 2009 (S. 1640) to create a new Medicare program based on “comprehensive lifestyle programs.” Such treatment plans would be designed by physicians specifically for each patient in the program. The plans can include nutritional therapy, exercise, medication management, care coordination, and tobacco-use cessation. Physicians wouldn't be paid if a patient were rehospitalized for a chronic illness accounted for in his or her plan. Sen. Wyden said in a statement that several trials of such a system, including those at Mutual of Omaha Insurance Co. and Highmark Blue Cross Blue Shield, have shown that comprehensive lifestyle programs can result in up to 50% reductions in medical costs.

Faulty Off-Label Prescribing?

A survey of 250 physicians—135 psychiatrists and 115 primary care doctors—found that many lack knowledge of certain drugs' approved indications. The study was published online in Pharmacoepidemiology and Drug Safety (doi: 10.1002/pds.1825). A large minority of physicians were mistaken that drugs were approved for uses they prescribed. For instance, 33% of respondents said they had prescribed lorazepam for chronic anxiety believing that it was approved for that, but the FDA warns against that use. Psychiatrists tended to be more accurate than primary care physicians.

The Food and Drug Administration's Advisory Committee for Reproductive Health Drugs voted that the benefits of denosumab to treat osteoporosis in postmenopausal women outweighed its risks, but the committee did not support use of the drug to prevent osteoporosis.

Denosumab (Prolia) manufacturer Amgen Inc. also was seeking approval of the human IgG2 monoclonal antibody to treat and prevent bone loss in women with breast cancer receiving hormone ablation therapy and to treat and prevent bone loss in men with prostate cancer receiving androgen deprivation therapy. The committee declined to support most of those uses, primarily because of concerns about long-term safety. Its members did vote 9-4 that the benefits outweighed the risks in treating bone loss in prostate cancer.

The committee did not formally vote on approval for any of the indications but took a series of votes on the risks and benefits of denosumab.

For osteoporosis prevention, advisory committee members expressed particular concern about exposing otherwise healthy women to a therapy that had been shown to have a slightly higher risk of causing serious skin infections and neoplasms. Dr. Scott Emerson, a biostatistician from the University of Washington, Seattle, said he could not say the benefits outweighed the risks, “because there's a lot of uncertainty in this low-risk population.”

Committee members also said that Amgen had not shown that denosumab did not affect the underlying disease or tumor progression when used in the breast cancer setting. Dr. Lawrence M. Nelson, a panel member and researcher at the Eunice Kennedy Shriver National Institute of Child Health and Human Development, said he could not support use of the drug in breast cancer, “because of concerns about the need for more data on how this affects the primary disease.”

But the committee was more enthusiastic about Amgen's studies in the prostate cancer setting, saying that the company had proved, at least in treating bone loss, that denosumab reduced fracture risk.

The FDA generally follows the advice of its panels.

The Food and Drug Administration's Advisory Committee for Reproductive Health Drugs voted that the benefits of denosumab to treat osteoporosis in postmenopausal women outweighed its risks, but the committee did not support use of the drug to prevent osteoporosis.

Denosumab (Prolia) manufacturer Amgen Inc. also was seeking approval of the human IgG2 monoclonal antibody to treat and prevent bone loss in women with breast cancer receiving hormone ablation therapy and to treat and prevent bone loss in men with prostate cancer receiving androgen deprivation therapy. The committee declined to support most of those uses, primarily because of concerns about long-term safety. Its members did vote 9-4 that the benefits outweighed the risks in treating bone loss in prostate cancer.

The committee did not formally vote on approval for any of the indications but took a series of votes on the risks and benefits of denosumab.

For osteoporosis prevention, advisory committee members expressed particular concern about exposing otherwise healthy women to a therapy that had been shown to have a slightly higher risk of causing serious skin infections and neoplasms. Dr. Scott Emerson, a biostatistician from the University of Washington, Seattle, said he could not say the benefits outweighed the risks, “because there's a lot of uncertainty in this low-risk population.”

Committee members also said that Amgen had not shown that denosumab did not affect the underlying disease or tumor progression when used in the breast cancer setting. Dr. Lawrence M. Nelson, a panel member and researcher at the Eunice Kennedy Shriver National Institute of Child Health and Human Development, said he could not support use of the drug in breast cancer, “because of concerns about the need for more data on how this affects the primary disease.”

But the committee was more enthusiastic about Amgen's studies in the prostate cancer setting, saying that the company had proved, at least in treating bone loss, that denosumab reduced fracture risk.

The FDA generally follows the advice of its panels.

The Food and Drug Administration's Advisory Committee for Reproductive Health Drugs voted that the benefits of denosumab to treat osteoporosis in postmenopausal women outweighed its risks, but the committee did not support use of the drug to prevent osteoporosis.

Denosumab (Prolia) manufacturer Amgen Inc. also was seeking approval of the human IgG2 monoclonal antibody to treat and prevent bone loss in women with breast cancer receiving hormone ablation therapy and to treat and prevent bone loss in men with prostate cancer receiving androgen deprivation therapy. The committee declined to support most of those uses, primarily because of concerns about long-term safety. Its members did vote 9-4 that the benefits outweighed the risks in treating bone loss in prostate cancer.

The committee did not formally vote on approval for any of the indications but took a series of votes on the risks and benefits of denosumab.

For osteoporosis prevention, advisory committee members expressed particular concern about exposing otherwise healthy women to a therapy that had been shown to have a slightly higher risk of causing serious skin infections and neoplasms. Dr. Scott Emerson, a biostatistician from the University of Washington, Seattle, said he could not say the benefits outweighed the risks, “because there's a lot of uncertainty in this low-risk population.”

Committee members also said that Amgen had not shown that denosumab did not affect the underlying disease or tumor progression when used in the breast cancer setting. Dr. Lawrence M. Nelson, a panel member and researcher at the Eunice Kennedy Shriver National Institute of Child Health and Human Development, said he could not support use of the drug in breast cancer, “because of concerns about the need for more data on how this affects the primary disease.”

But the committee was more enthusiastic about Amgen's studies in the prostate cancer setting, saying that the company had proved, at least in treating bone loss, that denosumab reduced fracture risk.

The FDA generally follows the advice of its panels.

Mental Health Costs Rise Steeply

For a decade, the cost of treating mental illness in the United States rose more quickly than that for any other major chronic condition, the Agency for Healthcare Research and Quality reported. The agency said that in 1996, it cost $35 million to treat conditions such as depression and bipolar disease, but by 2006, that figure had risen to $58 billion, with 36 million Americans receiving treatment. In contrast, heart disease spending increased from $72 billion to $78 billion, cancer spending rose from $47 billion to $58 billion, and asthma costs grew from $36 billion to $51 billion–according to the Medical Expenditures Panel Survey. The per-patient cost for treating mental disorders fell from $1,825 to $1,591.

Middle Aged, Elders Are Bingeing

A survey of 11,000 adults age 50 or older has determined that binge drinking is common. Fourteen percent of men and 3% of women over age 65 reported having five or more drinks in a day within the past 30 days. Among 50- to 64-year-olds, binge drinking was reported by 23% of men and 9% of women. The study, published online in the American Journal of Psychiatry (

doi:10.1176/appi.ajp.2009.09010016

1 in 5 Teens Shares Prescriptions

Interviews with almost 600 children aged 12-17 years found that 1 in 5 (122 of 592) said that he or she had loaned or borrowed a prescription drug, according to a study published online in the Journal of Adolescent Health by researchers from Academic Edge Inc. (

doi:10.1016/j.jadohealth.2009.06.002

Postdisaster Care Is Cost Effective

Giving comprehensive mental health care to a population after a natural disaster would have substantial public health benefits, according to a study in the August issue of Archives of General Psychiatry (2009;66:906-14). Researchers from various universities and foundations estimated the costs and effects of mental health screening, assessment, treatment, and care coordination for 11 million people after a disaster, such as those affected by Hurricanes Katrina and Rita in 2005. They assessed a medium-term response–that is, 7 months after an event–because fewer care strategies address that period than deal with the immediate postdisaster care. The team estimated that comprehensive care cost $1,133 per person, a total of $12.5 billion, during the 7-24 months after such a disaster.

Faulty Off-Label Prescribing?

A survey of 250 physicians–135 psychiatrists and 115 primary care doctors–found them lacking in knowledge of many drugs' approved indications. The study was published online in Pharmacoepidemiology and Drug Safety (

doi:10.1002/pds.1825

Macho Matters Medically

Middle-aged men who strongly idealize masculinity are only about half as likely as other men to seek preventive health care, according to a study presented at the American Sociological Association's annual meeting. However, among the macho men, those in blue-collar jobs were more likely to report obtaining care than were white-collar workers with strong masculinity beliefs. Presuming that jobs such as truck driving and farm work are more dependent on maintaining good health, the blue-white–collar difference suggests that the “masculinity threat of seeking health care is less concerning than the masculinity threat of not performing their jobs,” said lead investigator Kristen Springer, Ph.D., of Rutgers University. The study looked at the likelihood of men obtaining three preventive services: a complete physical exam, a flu shot, and a prostate exam.

Mental Health Costs Rise Steeply

For a decade, the cost of treating mental illness in the United States rose more quickly than that for any other major chronic condition, the Agency for Healthcare Research and Quality reported. The agency said that in 1996, it cost $35 million to treat conditions such as depression and bipolar disease, but by 2006, that figure had risen to $58 billion, with 36 million Americans receiving treatment. In contrast, heart disease spending increased from $72 billion to $78 billion, cancer spending rose from $47 billion to $58 billion, and asthma costs grew from $36 billion to $51 billion–according to the Medical Expenditures Panel Survey. The per-patient cost for treating mental disorders fell from $1,825 to $1,591.

Middle Aged, Elders Are Bingeing

A survey of 11,000 adults age 50 or older has determined that binge drinking is common. Fourteen percent of men and 3% of women over age 65 reported having five or more drinks in a day within the past 30 days. Among 50- to 64-year-olds, binge drinking was reported by 23% of men and 9% of women. The study, published online in the American Journal of Psychiatry (

doi:10.1176/appi.ajp.2009.09010016

1 in 5 Teens Shares Prescriptions

Interviews with almost 600 children aged 12-17 years found that 1 in 5 (122 of 592) said that he or she had loaned or borrowed a prescription drug, according to a study published online in the Journal of Adolescent Health by researchers from Academic Edge Inc. (

doi:10.1016/j.jadohealth.2009.06.002

Postdisaster Care Is Cost Effective

Giving comprehensive mental health care to a population after a natural disaster would have substantial public health benefits, according to a study in the August issue of Archives of General Psychiatry (2009;66:906-14). Researchers from various universities and foundations estimated the costs and effects of mental health screening, assessment, treatment, and care coordination for 11 million people after a disaster, such as those affected by Hurricanes Katrina and Rita in 2005. They assessed a medium-term response–that is, 7 months after an event–because fewer care strategies address that period than deal with the immediate postdisaster care. The team estimated that comprehensive care cost $1,133 per person, a total of $12.5 billion, during the 7-24 months after such a disaster.

Faulty Off-Label Prescribing?

A survey of 250 physicians–135 psychiatrists and 115 primary care doctors–found them lacking in knowledge of many drugs' approved indications. The study was published online in Pharmacoepidemiology and Drug Safety (

doi:10.1002/pds.1825

Macho Matters Medically

Middle-aged men who strongly idealize masculinity are only about half as likely as other men to seek preventive health care, according to a study presented at the American Sociological Association's annual meeting. However, among the macho men, those in blue-collar jobs were more likely to report obtaining care than were white-collar workers with strong masculinity beliefs. Presuming that jobs such as truck driving and farm work are more dependent on maintaining good health, the blue-white–collar difference suggests that the “masculinity threat of seeking health care is less concerning than the masculinity threat of not performing their jobs,” said lead investigator Kristen Springer, Ph.D., of Rutgers University. The study looked at the likelihood of men obtaining three preventive services: a complete physical exam, a flu shot, and a prostate exam.

Mental Health Costs Rise Steeply

For a decade, the cost of treating mental illness in the United States rose more quickly than that for any other major chronic condition, the Agency for Healthcare Research and Quality reported. The agency said that in 1996, it cost $35 million to treat conditions such as depression and bipolar disease, but by 2006, that figure had risen to $58 billion, with 36 million Americans receiving treatment. In contrast, heart disease spending increased from $72 billion to $78 billion, cancer spending rose from $47 billion to $58 billion, and asthma costs grew from $36 billion to $51 billion–according to the Medical Expenditures Panel Survey. The per-patient cost for treating mental disorders fell from $1,825 to $1,591.

Middle Aged, Elders Are Bingeing

A survey of 11,000 adults age 50 or older has determined that binge drinking is common. Fourteen percent of men and 3% of women over age 65 reported having five or more drinks in a day within the past 30 days. Among 50- to 64-year-olds, binge drinking was reported by 23% of men and 9% of women. The study, published online in the American Journal of Psychiatry (

doi:10.1176/appi.ajp.2009.09010016

1 in 5 Teens Shares Prescriptions

Interviews with almost 600 children aged 12-17 years found that 1 in 5 (122 of 592) said that he or she had loaned or borrowed a prescription drug, according to a study published online in the Journal of Adolescent Health by researchers from Academic Edge Inc. (

doi:10.1016/j.jadohealth.2009.06.002

Postdisaster Care Is Cost Effective

Giving comprehensive mental health care to a population after a natural disaster would have substantial public health benefits, according to a study in the August issue of Archives of General Psychiatry (2009;66:906-14). Researchers from various universities and foundations estimated the costs and effects of mental health screening, assessment, treatment, and care coordination for 11 million people after a disaster, such as those affected by Hurricanes Katrina and Rita in 2005. They assessed a medium-term response–that is, 7 months after an event–because fewer care strategies address that period than deal with the immediate postdisaster care. The team estimated that comprehensive care cost $1,133 per person, a total of $12.5 billion, during the 7-24 months after such a disaster.

Faulty Off-Label Prescribing?

A survey of 250 physicians–135 psychiatrists and 115 primary care doctors–found them lacking in knowledge of many drugs' approved indications. The study was published online in Pharmacoepidemiology and Drug Safety (

doi:10.1002/pds.1825

Macho Matters Medically

Middle-aged men who strongly idealize masculinity are only about half as likely as other men to seek preventive health care, according to a study presented at the American Sociological Association's annual meeting. However, among the macho men, those in blue-collar jobs were more likely to report obtaining care than were white-collar workers with strong masculinity beliefs. Presuming that jobs such as truck driving and farm work are more dependent on maintaining good health, the blue-white–collar difference suggests that the “masculinity threat of seeking health care is less concerning than the masculinity threat of not performing their jobs,” said lead investigator Kristen Springer, Ph.D., of Rutgers University. The study looked at the likelihood of men obtaining three preventive services: a complete physical exam, a flu shot, and a prostate exam.

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 any potential floor action in the House and Senate further into the fall, he said.

In press conferences and town hall meetings, President Obama has made it clear that he wants a health reform bill to sign before the end of the year. In a New Hampshire forum last month, he said, “If we let this moment pass—if we keep the system the way it is right now—we will continue to see 14,000 Americans lose their health insurance every day.”

Republican lawmakers, on the other hand, have sought to slow down the process. In a teleconference with reporters, Sen. John Cornyn (R-Tex.), who sits on the Senate Finance Committee, said, “One of my personal goals was to make sure we slowed this debate down so that we could have the time to analyze what's in the bills … and I think this has been a very important break in what's happening in Washington so we can 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.”

During the congressional recess, many senators and House members arrived home to find well-organized protests objecting to what protesters called “government-run health care.”

The administration scrambled to reassert its message, in part by launching a “Reality Check” Web page (www.whitehouse.gov/realitycheck

The Obama 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.”

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 be difficult to come back and negotiate with the industry this fall, he said.

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 Senate Health, Education, Labor and Pensions Committee was first to produce a plan. After 60 hours of debate and changes, the bill passed on a pure party-line vote on July 15.

The three House committees with jurisdiction over health—Ways and Means, Energy and Commerce, and Education and Labor—combined to create a bill that, again, passed along party lines, with the last vote coming July 31 in the Energy and Commerce Committee.

There are some large philosophical differences between the House and Senate plans (see chart); the addition of the Finance Committee's proposal, when it comes, is likely to widen the gap.

What's in the Bills?

Source ELSEVIER GLOBAL MEDICAL NEWS

Joyce Frieden and Mary Ellen Schneider contributed to this report.

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 any potential floor action in the House and Senate further into the fall, he said.

In press conferences and town hall meetings, President Obama has made it clear that he wants a health reform bill to sign before the end of the year. In a New Hampshire forum last month, he said, “If we let this moment pass—if we keep the system the way it is right now—we will continue to see 14,000 Americans lose their health insurance every day.”

Republican lawmakers, on the other hand, have sought to slow down the process. In a teleconference with reporters, Sen. John Cornyn (R-Tex.), who sits on the Senate Finance Committee, said, “One of my personal goals was to make sure we slowed this debate down so that we could have the time to analyze what's in the bills … and I think this has been a very important break in what's happening in Washington so we can 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.”

During the congressional recess, many senators and House members arrived home to find well-organized protests objecting to what protesters called “government-run health care.”

The administration scrambled to reassert its message, in part by launching a “Reality Check” Web page (www.whitehouse.gov/realitycheck

The Obama 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.”

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 be difficult to come back and negotiate with the industry this fall, he said.

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 Senate Health, Education, Labor and Pensions Committee was first to produce a plan. After 60 hours of debate and changes, the bill passed on a pure party-line vote on July 15.

The three House committees with jurisdiction over health—Ways and Means, Energy and Commerce, and Education and Labor—combined to create a bill that, again, passed along party lines, with the last vote coming July 31 in the Energy and Commerce Committee.

There are some large philosophical differences between the House and Senate plans (see chart); the addition of the Finance Committee's proposal, when it comes, is likely to widen the gap.

What's in the Bills?

Source ELSEVIER GLOBAL MEDICAL NEWS

Joyce Frieden and Mary Ellen Schneider contributed to this report.

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 any potential floor action in the House and Senate further into the fall, he said.

In press conferences and town hall meetings, President Obama has made it clear that he wants a health reform bill to sign before the end of the year. In a New Hampshire forum last month, he said, “If we let this moment pass—if we keep the system the way it is right now—we will continue to see 14,000 Americans lose their health insurance every day.”

Republican lawmakers, on the other hand, have sought to slow down the process. In a teleconference with reporters, Sen. John Cornyn (R-Tex.), who sits on the Senate Finance Committee, said, “One of my personal goals was to make sure we slowed this debate down so that we could have the time to analyze what's in the bills … and I think this has been a very important break in what's happening in Washington so we can 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.”

During the congressional recess, many senators and House members arrived home to find well-organized protests objecting to what protesters called “government-run health care.”

The administration scrambled to reassert its message, in part by launching a “Reality Check” Web page (www.whitehouse.gov/realitycheck

The Obama 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.”

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 be difficult to come back and negotiate with the industry this fall, he said.

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 Senate Health, Education, Labor and Pensions Committee was first to produce a plan. After 60 hours of debate and changes, the bill passed on a pure party-line vote on July 15.

The three House committees with jurisdiction over health—Ways and Means, Energy and Commerce, and Education and Labor—combined to create a bill that, again, passed along party lines, with the last vote coming July 31 in the Energy and Commerce Committee.

There are some large philosophical differences between the House and Senate plans (see chart); the addition of the Finance Committee's proposal, when it comes, is likely to widen the gap.

What's in the Bills?

Source ELSEVIER GLOBAL MEDICAL NEWS

Joyce Frieden and Mary Ellen Schneider contributed to this report.

Physicians providing moderate to deep sedation or anesthesia with office-based procedures in New York now must be accredited or face charges of professional misconduct, according to a state law.

Health officials are promoting the law as a means of improving quality of care and creating a safer environment for patients. It appears that it would primarily affect gastroenterologists who offer in-office endoscopy, but it would also affect podiatrists, ophthalmologists, dermatologists, and dentists.

In an interview, Dr. Scott Tenner, past president of the New York Society for Gastrointestinal Endoscopy (NYSGE), said that the law is effectively creating an unfunded mandate for physicians who want to offer in-office sedation, and will likely stop many from providing this service.

Also, there is no requirement that insurance companies pay a facility fee to cover those added costs for physician offices, said Dr. Tenner. Thus, it has become an unfunded mandate.

Gastroenterologists have been meeting with insurers in New York to attempt to secure extra payments, but so far, none have been very open to the idea, he said.

The New York State Department of Health says 500 providers have received accreditation in the year since the law was enacted. Almost 200 more are awaiting accreditation. Providers that had not received accreditation as of July 13 were barred from performing in-office surgery with sedation or general anesthesia.

A health department spokesman said in an interview that the agency has not yet determined the breakdown by specialty of accredited providers.

Going forward, any practice that wants to perform office-based surgery must receive accreditation through one of three agencies: the Accreditation Association for Ambulatory Health Care, the Joint Commission, or the American Association for Accreditation of Ambulatory Surgery Facilities Inc. (AAAASF).

Dr. Tenner said that the accreditation process is lengthy and costs at least $40,000. He foresees an uphill battle to secure reimbursement for a facility fee for physician offices, predicting that insurers will, in the short term, pay for patients to have procedures performed at ambulatory surgery centers and hospitals, even though the costs are greater.

New York is not the only state that has changed requirements for office-based procedures. The AAAASF estimates that 26 states have guidelines urging accreditation or require accreditation for in-office sedation or general anesthesia.

Physicians providing moderate to deep sedation or anesthesia with office-based procedures in New York now must be accredited or face charges of professional misconduct, according to a state law.

Health officials are promoting the law as a means of improving quality of care and creating a safer environment for patients. It appears that it would primarily affect gastroenterologists who offer in-office endoscopy, but it would also affect podiatrists, ophthalmologists, dermatologists, and dentists.

In an interview, Dr. Scott Tenner, past president of the New York Society for Gastrointestinal Endoscopy (NYSGE), said that the law is effectively creating an unfunded mandate for physicians who want to offer in-office sedation, and will likely stop many from providing this service.

Also, there is no requirement that insurance companies pay a facility fee to cover those added costs for physician offices, said Dr. Tenner. Thus, it has become an unfunded mandate.

Gastroenterologists have been meeting with insurers in New York to attempt to secure extra payments, but so far, none have been very open to the idea, he said.

The New York State Department of Health says 500 providers have received accreditation in the year since the law was enacted. Almost 200 more are awaiting accreditation. Providers that had not received accreditation as of July 13 were barred from performing in-office surgery with sedation or general anesthesia.

A health department spokesman said in an interview that the agency has not yet determined the breakdown by specialty of accredited providers.

Going forward, any practice that wants to perform office-based surgery must receive accreditation through one of three agencies: the Accreditation Association for Ambulatory Health Care, the Joint Commission, or the American Association for Accreditation of Ambulatory Surgery Facilities Inc. (AAAASF).

Dr. Tenner said that the accreditation process is lengthy and costs at least $40,000. He foresees an uphill battle to secure reimbursement for a facility fee for physician offices, predicting that insurers will, in the short term, pay for patients to have procedures performed at ambulatory surgery centers and hospitals, even though the costs are greater.

New York is not the only state that has changed requirements for office-based procedures. The AAAASF estimates that 26 states have guidelines urging accreditation or require accreditation for in-office sedation or general anesthesia.

Physicians providing moderate to deep sedation or anesthesia with office-based procedures in New York now must be accredited or face charges of professional misconduct, according to a state law.

Health officials are promoting the law as a means of improving quality of care and creating a safer environment for patients. It appears that it would primarily affect gastroenterologists who offer in-office endoscopy, but it would also affect podiatrists, ophthalmologists, dermatologists, and dentists.

In an interview, Dr. Scott Tenner, past president of the New York Society for Gastrointestinal Endoscopy (NYSGE), said that the law is effectively creating an unfunded mandate for physicians who want to offer in-office sedation, and will likely stop many from providing this service.

Also, there is no requirement that insurance companies pay a facility fee to cover those added costs for physician offices, said Dr. Tenner. Thus, it has become an unfunded mandate.

Gastroenterologists have been meeting with insurers in New York to attempt to secure extra payments, but so far, none have been very open to the idea, he said.

The New York State Department of Health says 500 providers have received accreditation in the year since the law was enacted. Almost 200 more are awaiting accreditation. Providers that had not received accreditation as of July 13 were barred from performing in-office surgery with sedation or general anesthesia.

A health department spokesman said in an interview that the agency has not yet determined the breakdown by specialty of accredited providers.

Going forward, any practice that wants to perform office-based surgery must receive accreditation through one of three agencies: the Accreditation Association for Ambulatory Health Care, the Joint Commission, or the American Association for Accreditation of Ambulatory Surgery Facilities Inc. (AAAASF).

Dr. Tenner said that the accreditation process is lengthy and costs at least $40,000. He foresees an uphill battle to secure reimbursement for a facility fee for physician offices, predicting that insurers will, in the short term, pay for patients to have procedures performed at ambulatory surgery centers and hospitals, even though the costs are greater.

New York is not the only state that has changed requirements for office-based procedures. The AAAASF estimates that 26 states have guidelines urging accreditation or require accreditation for in-office sedation or general anesthesia.

Bogus Botox Bust

An entire plastic surgery practice in Albany, N.Y., has pleaded guilty to administering a Botox substitute to some 150 patients. The U.S. Attorney for the Northern District of New York announced the plea, which covered five physicians, the practice administrator, and the supervisory nurse. They admitted that, for most of 2004, they injected patients with botulinum toxin type A [which is now known as onabotulinumtoxinA] that was manufactured by Toxin Research International Inc. of Arizona but labeled as Botox Cosmetic, which is made by Allergan. The Toxin Research product was never approved by the Food and Drug Administration. The physicians and practice employees told patients they were receiving the real Botox and charged them the same price, about $100,000 in total. The practice may have to pay $500,000 in restitution. Each defendant also could face up to a year in prison. Sentencing is scheduled for Dec. 14. The inquiry that led to the guilty pleas was conducted by the FDA's Office of Criminal Investigations.

More Warnings on Injections

The Physicians Coalition for Injectable Safety is warning that mesotherapy and carboxytherapy injections have not been proven safe or effective. The coalition is an alliance of several specialty societies, including a few that have previously warned against the therapies. Practitioners doing mesotherapy and carboxytherapy claim that both procedures can sculpt and contour the body and reduce cellulite. Neither has been approved by the FDA. The Aesthetic Surgery Education and Research Foundation, however, has received the FDA's blessing to conduct a study of mesotherapy. That nonprofit organization is supported by the professional societies and is open to donations from those who want to support research in the field.

Skin Sanitizers Seized

U.S. Marshals have seized skin sanitizers produced by Clarcon Biological Chemistry Laboratory. The seizure had been requested by the FDA, which said that the products were contaminated with bacteria, after Clarcon refused to quickly destroy the various sanitizers and skin protectants that were manufactured at its plant in Roy, Utah. No case of illnesses has been linked to the contamination, the FDA reported. The products, sold under brands such as Dermasentials, Iron Fist, Skin Shield Restaurant, and Skin Shield Industrial, are promoted as antimicrobial agents. More than 800,000 bottles of Clarcon products have been sold since 2007, the FDA said. The agency advised consumers to throw out all Clarcon products in their possession.

Fragrance Ingredient List Coming

The International Fragrance Association announced that it will soon publish on its Web site a list of ingredients used in the fragrance industry. “To support our goal of increased transparency, we have determined that publishing an alphabetized list of fragrance ingredients would be helpful when communicating the industry's extensive safety program,” said IFRA Director General Jean-Pierre Houri. All materials—natural and synthetic—will be listed alphabetically by chemical name and by the Chemical Abstracts Service number. The IFRA is thus joining manufacturers of products for cleaning, air care, automotive care, polishing, and floor maintenance, all of which have agreed to voluntarily disclose ingredients by Jan. 10, 2010.

Biosimilars Market: $45 Million

A research firm pegs the U.S. market for generic versions of biotechnology products, called biosimilars or biogenerics, at $45 million by 2015, if the federal government clears a regulatory path for such products. The major health reform bills now making their way through Congress would do so. Kalorama Information said that biosimilars of human growth hormone, insulin, and some protein and recombinant DNA-based therapies would probably be the first generics available. Early sales aren't likely to be robust, partly because the brand name manufacturers will defend their turf, the Kalorama report predicted. Nevertheless, a few capable generic makers “will hit the ground running in the U.S. once approval [of biosimilars] is granted,” Kalorama's Bruce Carlson said in a statement.

Lilly Payment Data Now Public

Eli Lilly & Co. has made good on its promise to publish how much it pays physicians and other health care professionals in consulting fees, honoraria, and the like. The drugmaker detailed the payments for the first quarter of 2009 at

www.lillyfacultyregistry.com

Bogus Botox Bust

An entire plastic surgery practice in Albany, N.Y., has pleaded guilty to administering a Botox substitute to some 150 patients. The U.S. Attorney for the Northern District of New York announced the plea, which covered five physicians, the practice administrator, and the supervisory nurse. They admitted that, for most of 2004, they injected patients with botulinum toxin type A [which is now known as onabotulinumtoxinA] that was manufactured by Toxin Research International Inc. of Arizona but labeled as Botox Cosmetic, which is made by Allergan. The Toxin Research product was never approved by the Food and Drug Administration. The physicians and practice employees told patients they were receiving the real Botox and charged them the same price, about $100,000 in total. The practice may have to pay $500,000 in restitution. Each defendant also could face up to a year in prison. Sentencing is scheduled for Dec. 14. The inquiry that led to the guilty pleas was conducted by the FDA's Office of Criminal Investigations.

More Warnings on Injections

The Physicians Coalition for Injectable Safety is warning that mesotherapy and carboxytherapy injections have not been proven safe or effective. The coalition is an alliance of several specialty societies, including a few that have previously warned against the therapies. Practitioners doing mesotherapy and carboxytherapy claim that both procedures can sculpt and contour the body and reduce cellulite. Neither has been approved by the FDA. The Aesthetic Surgery Education and Research Foundation, however, has received the FDA's blessing to conduct a study of mesotherapy. That nonprofit organization is supported by the professional societies and is open to donations from those who want to support research in the field.

Skin Sanitizers Seized

U.S. Marshals have seized skin sanitizers produced by Clarcon Biological Chemistry Laboratory. The seizure had been requested by the FDA, which said that the products were contaminated with bacteria, after Clarcon refused to quickly destroy the various sanitizers and skin protectants that were manufactured at its plant in Roy, Utah. No case of illnesses has been linked to the contamination, the FDA reported. The products, sold under brands such as Dermasentials, Iron Fist, Skin Shield Restaurant, and Skin Shield Industrial, are promoted as antimicrobial agents. More than 800,000 bottles of Clarcon products have been sold since 2007, the FDA said. The agency advised consumers to throw out all Clarcon products in their possession.

Fragrance Ingredient List Coming

The International Fragrance Association announced that it will soon publish on its Web site a list of ingredients used in the fragrance industry. “To support our goal of increased transparency, we have determined that publishing an alphabetized list of fragrance ingredients would be helpful when communicating the industry's extensive safety program,” said IFRA Director General Jean-Pierre Houri. All materials—natural and synthetic—will be listed alphabetically by chemical name and by the Chemical Abstracts Service number. The IFRA is thus joining manufacturers of products for cleaning, air care, automotive care, polishing, and floor maintenance, all of which have agreed to voluntarily disclose ingredients by Jan. 10, 2010.

Biosimilars Market: $45 Million

A research firm pegs the U.S. market for generic versions of biotechnology products, called biosimilars or biogenerics, at $45 million by 2015, if the federal government clears a regulatory path for such products. The major health reform bills now making their way through Congress would do so. Kalorama Information said that biosimilars of human growth hormone, insulin, and some protein and recombinant DNA-based therapies would probably be the first generics available. Early sales aren't likely to be robust, partly because the brand name manufacturers will defend their turf, the Kalorama report predicted. Nevertheless, a few capable generic makers “will hit the ground running in the U.S. once approval [of biosimilars] is granted,” Kalorama's Bruce Carlson said in a statement.

Lilly Payment Data Now Public

Eli Lilly & Co. has made good on its promise to publish how much it pays physicians and other health care professionals in consulting fees, honoraria, and the like. The drugmaker detailed the payments for the first quarter of 2009 at

www.lillyfacultyregistry.com

Bogus Botox Bust

An entire plastic surgery practice in Albany, N.Y., has pleaded guilty to administering a Botox substitute to some 150 patients. The U.S. Attorney for the Northern District of New York announced the plea, which covered five physicians, the practice administrator, and the supervisory nurse. They admitted that, for most of 2004, they injected patients with botulinum toxin type A [which is now known as onabotulinumtoxinA] that was manufactured by Toxin Research International Inc. of Arizona but labeled as Botox Cosmetic, which is made by Allergan. The Toxin Research product was never approved by the Food and Drug Administration. The physicians and practice employees told patients they were receiving the real Botox and charged them the same price, about $100,000 in total. The practice may have to pay $500,000 in restitution. Each defendant also could face up to a year in prison. Sentencing is scheduled for Dec. 14. The inquiry that led to the guilty pleas was conducted by the FDA's Office of Criminal Investigations.

More Warnings on Injections

The Physicians Coalition for Injectable Safety is warning that mesotherapy and carboxytherapy injections have not been proven safe or effective. The coalition is an alliance of several specialty societies, including a few that have previously warned against the therapies. Practitioners doing mesotherapy and carboxytherapy claim that both procedures can sculpt and contour the body and reduce cellulite. Neither has been approved by the FDA. The Aesthetic Surgery Education and Research Foundation, however, has received the FDA's blessing to conduct a study of mesotherapy. That nonprofit organization is supported by the professional societies and is open to donations from those who want to support research in the field.

Skin Sanitizers Seized

U.S. Marshals have seized skin sanitizers produced by Clarcon Biological Chemistry Laboratory. The seizure had been requested by the FDA, which said that the products were contaminated with bacteria, after Clarcon refused to quickly destroy the various sanitizers and skin protectants that were manufactured at its plant in Roy, Utah. No case of illnesses has been linked to the contamination, the FDA reported. The products, sold under brands such as Dermasentials, Iron Fist, Skin Shield Restaurant, and Skin Shield Industrial, are promoted as antimicrobial agents. More than 800,000 bottles of Clarcon products have been sold since 2007, the FDA said. The agency advised consumers to throw out all Clarcon products in their possession.

Fragrance Ingredient List Coming

The International Fragrance Association announced that it will soon publish on its Web site a list of ingredients used in the fragrance industry. “To support our goal of increased transparency, we have determined that publishing an alphabetized list of fragrance ingredients would be helpful when communicating the industry's extensive safety program,” said IFRA Director General Jean-Pierre Houri. All materials—natural and synthetic—will be listed alphabetically by chemical name and by the Chemical Abstracts Service number. The IFRA is thus joining manufacturers of products for cleaning, air care, automotive care, polishing, and floor maintenance, all of which have agreed to voluntarily disclose ingredients by Jan. 10, 2010.

Biosimilars Market: $45 Million

A research firm pegs the U.S. market for generic versions of biotechnology products, called biosimilars or biogenerics, at $45 million by 2015, if the federal government clears a regulatory path for such products. The major health reform bills now making their way through Congress would do so. Kalorama Information said that biosimilars of human growth hormone, insulin, and some protein and recombinant DNA-based therapies would probably be the first generics available. Early sales aren't likely to be robust, partly because the brand name manufacturers will defend their turf, the Kalorama report predicted. Nevertheless, a few capable generic makers “will hit the ground running in the U.S. once approval [of biosimilars] is granted,” Kalorama's Bruce Carlson said in a statement.

Lilly Payment Data Now Public

Eli Lilly & Co. has made good on its promise to publish how much it pays physicians and other health care professionals in consulting fees, honoraria, and the like. The drugmaker detailed the payments for the first quarter of 2009 at

www.lillyfacultyregistry.com

The Food and Drug Administration's recent decision to require new generic, or “established,” names for botulinum toxins is not likely to have much of an impact on patient safety, say dermatologists.

Citing the introduction of Dysport in April as the agency's trigger, the FDA said that it was seeking to reduce confusion and the potential for prescribing errors. Dysport is a botulinum toxin A, similar to Botox.

Now, Botox will be known generically as onabotulinumtoxinA; Myobloc will be known as rimabotulinumtoxinB, and Dysport will be known as abobotulinumtoxinA.

Each product will also carry the same boxed warning of the potential for distant spreading, which can lead to life-threatening respiratory difficulties. FDA first required this warning in April, but Dysport was not then on the market.

All of the toxins also will have a Medication Guide for patients discussing the potential for adverse effects from distant spreading.

“The revised labels also emphasize that the different botulinum toxin products are not interchangeable, because the units used to measure the products are different,” the FDA said in a statement.

“With each product having a distinct established name, we believe the chance of serious medication errors is minimized,” an agency spokeswoman said in an interview.

But several dermatologists said that since botulinum toxins are generally ordered, purchased, and dispensed by physicians, the new requirement won't have much effect.

Dr. Christopher Zachary, who is chairman of the dermatology department at the University of California in Irvine, said that he supports the FDA's efforts to increase safety. But, he added, “I'd suggest from a practical point of view that people keep using trade names,” noting that these are the names that stick in the minds of physicians, staff, and patients.

Dr. Michael Kaminer, assistant clinical professor in the dermatologic surgery and oncology section at Yale University, New Haven, Conn., said in an interview, “I can't imagine this would have any impact on consumers or physicians.” Distinct established names for the toxins could make a difference when and if a generic version becomes available, added Dr. Kaminer.

Dr. Kaminer disclosed no conflict of interest. Dr. Zachary disclosed that he receives grants and research support from Allergan.

'I'd suggest from a practical point of view that people keep using trade names.'

Source DR. ZACHARY

The Food and Drug Administration's recent decision to require new generic, or “established,” names for botulinum toxins is not likely to have much of an impact on patient safety, say dermatologists.

Citing the introduction of Dysport in April as the agency's trigger, the FDA said that it was seeking to reduce confusion and the potential for prescribing errors. Dysport is a botulinum toxin A, similar to Botox.

Now, Botox will be known generically as onabotulinumtoxinA; Myobloc will be known as rimabotulinumtoxinB, and Dysport will be known as abobotulinumtoxinA.

Each product will also carry the same boxed warning of the potential for distant spreading, which can lead to life-threatening respiratory difficulties. FDA first required this warning in April, but Dysport was not then on the market.

All of the toxins also will have a Medication Guide for patients discussing the potential for adverse effects from distant spreading.

“The revised labels also emphasize that the different botulinum toxin products are not interchangeable, because the units used to measure the products are different,” the FDA said in a statement.

“With each product having a distinct established name, we believe the chance of serious medication errors is minimized,” an agency spokeswoman said in an interview.

But several dermatologists said that since botulinum toxins are generally ordered, purchased, and dispensed by physicians, the new requirement won't have much effect.

Dr. Christopher Zachary, who is chairman of the dermatology department at the University of California in Irvine, said that he supports the FDA's efforts to increase safety. But, he added, “I'd suggest from a practical point of view that people keep using trade names,” noting that these are the names that stick in the minds of physicians, staff, and patients.

Dr. Michael Kaminer, assistant clinical professor in the dermatologic surgery and oncology section at Yale University, New Haven, Conn., said in an interview, “I can't imagine this would have any impact on consumers or physicians.” Distinct established names for the toxins could make a difference when and if a generic version becomes available, added Dr. Kaminer.

Dr. Kaminer disclosed no conflict of interest. Dr. Zachary disclosed that he receives grants and research support from Allergan.

'I'd suggest from a practical point of view that people keep using trade names.'

Source DR. ZACHARY

The Food and Drug Administration's recent decision to require new generic, or “established,” names for botulinum toxins is not likely to have much of an impact on patient safety, say dermatologists.

Citing the introduction of Dysport in April as the agency's trigger, the FDA said that it was seeking to reduce confusion and the potential for prescribing errors. Dysport is a botulinum toxin A, similar to Botox.

Now, Botox will be known generically as onabotulinumtoxinA; Myobloc will be known as rimabotulinumtoxinB, and Dysport will be known as abobotulinumtoxinA.

Each product will also carry the same boxed warning of the potential for distant spreading, which can lead to life-threatening respiratory difficulties. FDA first required this warning in April, but Dysport was not then on the market.

All of the toxins also will have a Medication Guide for patients discussing the potential for adverse effects from distant spreading.

“The revised labels also emphasize that the different botulinum toxin products are not interchangeable, because the units used to measure the products are different,” the FDA said in a statement.

“With each product having a distinct established name, we believe the chance of serious medication errors is minimized,” an agency spokeswoman said in an interview.

But several dermatologists said that since botulinum toxins are generally ordered, purchased, and dispensed by physicians, the new requirement won't have much effect.

Dr. Christopher Zachary, who is chairman of the dermatology department at the University of California in Irvine, said that he supports the FDA's efforts to increase safety. But, he added, “I'd suggest from a practical point of view that people keep using trade names,” noting that these are the names that stick in the minds of physicians, staff, and patients.

Dr. Michael Kaminer, assistant clinical professor in the dermatologic surgery and oncology section at Yale University, New Haven, Conn., said in an interview, “I can't imagine this would have any impact on consumers or physicians.” Distinct established names for the toxins could make a difference when and if a generic version becomes available, added Dr. Kaminer.

Dr. Kaminer disclosed no conflict of interest. Dr. Zachary disclosed that he receives grants and research support from Allergan.

'I'd suggest from a practical point of view that people keep using trade names.'

Source DR. ZACHARY

Humana pays physicians more quickly and denies fewer claims than other insurers, according to the fourth annual survey of payer practices by AthenaHealth Inc.

The survey ranks payers based on a series of measures, including the number of days that claims spend in accounts receivable, percentage of claims resolved on first submission, percentage of each claim shifted to the patient, denial rate, and “transparency” of denials, including what percentage of denials are paid after one additional submission.

The AthenaHealth survey also evaluated the percentage of claims requiring medical documentation to justify the payment.

The physician practice management company evaluated 172 national, regional, and government payers in 40 states. The rankings are based on data from 18,000 providers, and represent 40 million medical charge lines and $7 billion in charges for 2008. The previous year's rankings were based on data from 12,000 providers and 30 million charge lines.

Overall, in 2008, insurers paid physicians 5.3% faster and denied 9% fewer claims than in 2007, the company said.

Humana was also No. 1 in the first survey, which was published in 2006. At that time, a claim at Humana averaged 29 days in accounts receivable; by 2008, a claim spent 26 days in accounts receivable. The number of days in accounts receivable is not substantially different from that of the other top-rated payers, but Humana also scored well in other categories.

Overall, 96% of claims were paid on initial submission, a slight edge over competitors. Only 2% of claims required medical documentation, and only 0.6% of claims were not paid due to Humana's departure from national coding standards.

“Humana's ascent to the top of the rankings can be credited to faster claims payment with fewer denials than its peers,” Dr. William F. Jessee, president and CEO of the Medical Group Management Association, said in a statement. He said the MGMA commended Humana, especially for listening to the organization's concerns, but added that “there remains considerable room for improvement across the industry.”

For the past few years, Aetna and Cigna have remained near the top of the payer rankings, as has Medicare, which was in fifth place this year. Medicare claims spent an average of 33 days in accounts receivable, and 93% were paid on first submission.

In addition, Medicare recipients shoulder the lowest liability for their care. Commercial payers have been shifting more costs to the patients; that makes it harder for physicians because no universal tool exists to estimate what the patient owes at the time of service, according to AthenaHealth.

Medicare patients generally have a 2% liability. By comparison, the patient liability for those receiving coverage from a BlueCross BlueShield plan was 9%, a 2% increase from the previous year, according to AthenaHealth.

The big commercial insurers, including Aetna, Cigna, Humana, and UnitedHealthcare, had the second-highest patient liability at an average of 8.47%, up from 3.4% in 2007.

For the most part, Medicaid plans continue to perform poorly on all measures, according to AthenaHealth. In 2008, a claim submitted to the average state Medicaid plan spent twice as many days in accounts receivable, compared with the average payer. Denial rates were three to four times higher, averaging 22% in 2008. Some state plans paid as few as 60% of claims on first submission.

AthenaHealth predicted that the continuing recession would likely put further strain on the performance of Medicaid programs.

Humana pays physicians more quickly and denies fewer claims than other insurers, according to the fourth annual survey of payer practices by AthenaHealth Inc.

The survey ranks payers based on a series of measures, including the number of days that claims spend in accounts receivable, percentage of claims resolved on first submission, percentage of each claim shifted to the patient, denial rate, and “transparency” of denials, including what percentage of denials are paid after one additional submission.

The AthenaHealth survey also evaluated the percentage of claims requiring medical documentation to justify the payment.

The physician practice management company evaluated 172 national, regional, and government payers in 40 states. The rankings are based on data from 18,000 providers, and represent 40 million medical charge lines and $7 billion in charges for 2008. The previous year's rankings were based on data from 12,000 providers and 30 million charge lines.

Overall, in 2008, insurers paid physicians 5.3% faster and denied 9% fewer claims than in 2007, the company said.

Humana was also No. 1 in the first survey, which was published in 2006. At that time, a claim at Humana averaged 29 days in accounts receivable; by 2008, a claim spent 26 days in accounts receivable. The number of days in accounts receivable is not substantially different from that of the other top-rated payers, but Humana also scored well in other categories.

Overall, 96% of claims were paid on initial submission, a slight edge over competitors. Only 2% of claims required medical documentation, and only 0.6% of claims were not paid due to Humana's departure from national coding standards.

“Humana's ascent to the top of the rankings can be credited to faster claims payment with fewer denials than its peers,” Dr. William F. Jessee, president and CEO of the Medical Group Management Association, said in a statement. He said the MGMA commended Humana, especially for listening to the organization's concerns, but added that “there remains considerable room for improvement across the industry.”

For the past few years, Aetna and Cigna have remained near the top of the payer rankings, as has Medicare, which was in fifth place this year. Medicare claims spent an average of 33 days in accounts receivable, and 93% were paid on first submission.

In addition, Medicare recipients shoulder the lowest liability for their care. Commercial payers have been shifting more costs to the patients; that makes it harder for physicians because no universal tool exists to estimate what the patient owes at the time of service, according to AthenaHealth.

Medicare patients generally have a 2% liability. By comparison, the patient liability for those receiving coverage from a BlueCross BlueShield plan was 9%, a 2% increase from the previous year, according to AthenaHealth.

The big commercial insurers, including Aetna, Cigna, Humana, and UnitedHealthcare, had the second-highest patient liability at an average of 8.47%, up from 3.4% in 2007.

For the most part, Medicaid plans continue to perform poorly on all measures, according to AthenaHealth. In 2008, a claim submitted to the average state Medicaid plan spent twice as many days in accounts receivable, compared with the average payer. Denial rates were three to four times higher, averaging 22% in 2008. Some state plans paid as few as 60% of claims on first submission.

AthenaHealth predicted that the continuing recession would likely put further strain on the performance of Medicaid programs.

Humana pays physicians more quickly and denies fewer claims than other insurers, according to the fourth annual survey of payer practices by AthenaHealth Inc.

The survey ranks payers based on a series of measures, including the number of days that claims spend in accounts receivable, percentage of claims resolved on first submission, percentage of each claim shifted to the patient, denial rate, and “transparency” of denials, including what percentage of denials are paid after one additional submission.

The AthenaHealth survey also evaluated the percentage of claims requiring medical documentation to justify the payment.

The physician practice management company evaluated 172 national, regional, and government payers in 40 states. The rankings are based on data from 18,000 providers, and represent 40 million medical charge lines and $7 billion in charges for 2008. The previous year's rankings were based on data from 12,000 providers and 30 million charge lines.

Overall, in 2008, insurers paid physicians 5.3% faster and denied 9% fewer claims than in 2007, the company said.

Humana was also No. 1 in the first survey, which was published in 2006. At that time, a claim at Humana averaged 29 days in accounts receivable; by 2008, a claim spent 26 days in accounts receivable. The number of days in accounts receivable is not substantially different from that of the other top-rated payers, but Humana also scored well in other categories.

Overall, 96% of claims were paid on initial submission, a slight edge over competitors. Only 2% of claims required medical documentation, and only 0.6% of claims were not paid due to Humana's departure from national coding standards.

“Humana's ascent to the top of the rankings can be credited to faster claims payment with fewer denials than its peers,” Dr. William F. Jessee, president and CEO of the Medical Group Management Association, said in a statement. He said the MGMA commended Humana, especially for listening to the organization's concerns, but added that “there remains considerable room for improvement across the industry.”

For the past few years, Aetna and Cigna have remained near the top of the payer rankings, as has Medicare, which was in fifth place this year. Medicare claims spent an average of 33 days in accounts receivable, and 93% were paid on first submission.

In addition, Medicare recipients shoulder the lowest liability for their care. Commercial payers have been shifting more costs to the patients; that makes it harder for physicians because no universal tool exists to estimate what the patient owes at the time of service, according to AthenaHealth.

Medicare patients generally have a 2% liability. By comparison, the patient liability for those receiving coverage from a BlueCross BlueShield plan was 9%, a 2% increase from the previous year, according to AthenaHealth.

The big commercial insurers, including Aetna, Cigna, Humana, and UnitedHealthcare, had the second-highest patient liability at an average of 8.47%, up from 3.4% in 2007.

For the most part, Medicaid plans continue to perform poorly on all measures, according to AthenaHealth. In 2008, a claim submitted to the average state Medicaid plan spent twice as many days in accounts receivable, compared with the average payer. Denial rates were three to four times higher, averaging 22% in 2008. Some state plans paid as few as 60% of claims on first submission.

AthenaHealth predicted that the continuing recession would likely put further strain on the performance of Medicaid programs.

Humana pays physicians more quickly and denies fewer claims than other insurers, according to the fourth annual survey of payer practices by AthenaHealth Inc.

The survey ranks payers based on a series of measures, including the number of days that claims spend in accounts receivable, percentage of claims resolved on first submission, percentage of each claim shifted to the patient, denial rate, and “transparency” of denials, including what percentage of denials are paid after one additional submission.

The AthenaHealth survey also evaluated the percentage of claims requiring medical documentation to justify the payment.

The physician practice management company evaluated 172 national, regional, and government payers in 40 states. The rankings are based on data from 18,000 providers, and represent 40 million medical charge lines and $7 billion in charges for 2008.

The previous year's rankings were based on data from 12,000 providers and 30 million charge lines.

Overall, in 2008, insurers paid physicians 5.3% faster and denied 9% fewer claims than in 2007, the company said.

Humana was also No. 1 in the first survey, which was published in 2006. At that time, a claim at Humana averaged 29 days in accounts receivable; by 2008, a claim spent 26 days in accounts receivable. The number of days in accounts receivable is not substantially different from that of the other top-rated payers, but Humana also scored well in other categories.

Overall, 96% of claims were paid on initial submission, a slight edge over competitors. Only 2% of claims required medical documentation, and only 0.6% of claims were not paid due to Humana's departure from national coding standards.

“Humana's ascent to the top of the rankings can be credited to faster claims payment with fewer denials than its peers,” Dr. William F. Jessee, president and CEO of the Medical Group Management Association, said in a statement. Dr. Jessee said the MGMA commended Humana, especially for listening to the organization's concerns, but added that “there remains considerable room for improvement across the industry.”

For the past few years, Aetna and Cigna have remained near the top of the payer rankings, as has Medicare, which was in fifth place this year. Medicare claims spent an average of 33 days in accounts receivable, and 93% were paid on first submission.

In addition, Medicare recipients shoulder the lowest liability for their care. Commercial payers have been shifting more costs to the patients; that makes it harder for physicians because no universal tool exists to estimate what the patient owes at time of service, according to AthenaHealth.

Medicare patients generally have a 2% liability. By comparison, the patient liability for those receiving coverage from a BlueCross BlueShield plan was 9%, a 2% increase from the previous year, according to AthenaHealth.

The big commercial insurers, including Aetna, Cigna, Humana, and UnitedHealthcare, had the second-highest patient liability at an average of 8.47%, up from 3.4% in 2007.

For the most part, Medicaid plans continue to perform poorly on all measures, according to AthenaHealth. In 2008, a claim submitted to the average state Medicaid plan spent twice as many days in accounts receivable, compared with the average payer. Denial rates were three to four times higher, averaging 22% in 2008. Some state plans paid as few as 60% of claims on first submission.

Louisiana had the top-performing Medicaid program, with claims averaging 43 days in accounts receivable, and 86% being paid on first pass. In comparison, in New York, claims stayed an average of 160 days in accounts receivable and only 62% were paid on the first submission.

AthenaHealth predicted that the continuing recession would likely put further strain on the performance of Medicaid programs.

Humana pays physicians more quickly and denies fewer claims than other insurers, according to the fourth annual survey of payer practices by AthenaHealth Inc.

The survey ranks payers based on a series of measures, including the number of days that claims spend in accounts receivable, percentage of claims resolved on first submission, percentage of each claim shifted to the patient, denial rate, and “transparency” of denials, including what percentage of denials are paid after one additional submission.

The AthenaHealth survey also evaluated the percentage of claims requiring medical documentation to justify the payment.

The physician practice management company evaluated 172 national, regional, and government payers in 40 states. The rankings are based on data from 18,000 providers, and represent 40 million medical charge lines and $7 billion in charges for 2008.

The previous year's rankings were based on data from 12,000 providers and 30 million charge lines.

Overall, in 2008, insurers paid physicians 5.3% faster and denied 9% fewer claims than in 2007, the company said.

Humana was also No. 1 in the first survey, which was published in 2006. At that time, a claim at Humana averaged 29 days in accounts receivable; by 2008, a claim spent 26 days in accounts receivable. The number of days in accounts receivable is not substantially different from that of the other top-rated payers, but Humana also scored well in other categories.

Overall, 96% of claims were paid on initial submission, a slight edge over competitors. Only 2% of claims required medical documentation, and only 0.6% of claims were not paid due to Humana's departure from national coding standards.

“Humana's ascent to the top of the rankings can be credited to faster claims payment with fewer denials than its peers,” Dr. William F. Jessee, president and CEO of the Medical Group Management Association, said in a statement. Dr. Jessee said the MGMA commended Humana, especially for listening to the organization's concerns, but added that “there remains considerable room for improvement across the industry.”

For the past few years, Aetna and Cigna have remained near the top of the payer rankings, as has Medicare, which was in fifth place this year. Medicare claims spent an average of 33 days in accounts receivable, and 93% were paid on first submission.

In addition, Medicare recipients shoulder the lowest liability for their care. Commercial payers have been shifting more costs to the patients; that makes it harder for physicians because no universal tool exists to estimate what the patient owes at time of service, according to AthenaHealth.

Medicare patients generally have a 2% liability. By comparison, the patient liability for those receiving coverage from a BlueCross BlueShield plan was 9%, a 2% increase from the previous year, according to AthenaHealth.

The big commercial insurers, including Aetna, Cigna, Humana, and UnitedHealthcare, had the second-highest patient liability at an average of 8.47%, up from 3.4% in 2007.

For the most part, Medicaid plans continue to perform poorly on all measures, according to AthenaHealth. In 2008, a claim submitted to the average state Medicaid plan spent twice as many days in accounts receivable, compared with the average payer. Denial rates were three to four times higher, averaging 22% in 2008. Some state plans paid as few as 60% of claims on first submission.

Louisiana had the top-performing Medicaid program, with claims averaging 43 days in accounts receivable, and 86% being paid on first pass. In comparison, in New York, claims stayed an average of 160 days in accounts receivable and only 62% were paid on the first submission.

AthenaHealth predicted that the continuing recession would likely put further strain on the performance of Medicaid programs.

Humana pays physicians more quickly and denies fewer claims than other insurers, according to the fourth annual survey of payer practices by AthenaHealth Inc.

The survey ranks payers based on a series of measures, including the number of days that claims spend in accounts receivable, percentage of claims resolved on first submission, percentage of each claim shifted to the patient, denial rate, and “transparency” of denials, including what percentage of denials are paid after one additional submission.

The AthenaHealth survey also evaluated the percentage of claims requiring medical documentation to justify the payment.

The physician practice management company evaluated 172 national, regional, and government payers in 40 states. The rankings are based on data from 18,000 providers, and represent 40 million medical charge lines and $7 billion in charges for 2008.

The previous year's rankings were based on data from 12,000 providers and 30 million charge lines.

Overall, in 2008, insurers paid physicians 5.3% faster and denied 9% fewer claims than in 2007, the company said.

Humana was also No. 1 in the first survey, which was published in 2006. At that time, a claim at Humana averaged 29 days in accounts receivable; by 2008, a claim spent 26 days in accounts receivable. The number of days in accounts receivable is not substantially different from that of the other top-rated payers, but Humana also scored well in other categories.

Overall, 96% of claims were paid on initial submission, a slight edge over competitors. Only 2% of claims required medical documentation, and only 0.6% of claims were not paid due to Humana's departure from national coding standards.

“Humana's ascent to the top of the rankings can be credited to faster claims payment with fewer denials than its peers,” Dr. William F. Jessee, president and CEO of the Medical Group Management Association, said in a statement. Dr. Jessee said the MGMA commended Humana, especially for listening to the organization's concerns, but added that “there remains considerable room for improvement across the industry.”

For the past few years, Aetna and Cigna have remained near the top of the payer rankings, as has Medicare, which was in fifth place this year. Medicare claims spent an average of 33 days in accounts receivable, and 93% were paid on first submission.

In addition, Medicare recipients shoulder the lowest liability for their care. Commercial payers have been shifting more costs to the patients; that makes it harder for physicians because no universal tool exists to estimate what the patient owes at time of service, according to AthenaHealth.

Medicare patients generally have a 2% liability. By comparison, the patient liability for those receiving coverage from a BlueCross BlueShield plan was 9%, a 2% increase from the previous year, according to AthenaHealth.

The big commercial insurers, including Aetna, Cigna, Humana, and UnitedHealthcare, had the second-highest patient liability at an average of 8.47%, up from 3.4% in 2007.

For the most part, Medicaid plans continue to perform poorly on all measures, according to AthenaHealth. In 2008, a claim submitted to the average state Medicaid plan spent twice as many days in accounts receivable, compared with the average payer. Denial rates were three to four times higher, averaging 22% in 2008. Some state plans paid as few as 60% of claims on first submission.

Louisiana had the top-performing Medicaid program, with claims averaging 43 days in accounts receivable, and 86% being paid on first pass. In comparison, in New York, claims stayed an average of 160 days in accounts receivable and only 62% were paid on the first submission.

AthenaHealth predicted that the continuing recession would likely put further strain on the performance of Medicaid programs.

Citing a significant loss of market share, Roche announced in June that it will cease manufacturing the retinoid Accutane, but dermatologists say that the company's pullout will not affect patients' access to the drug and will not have any impact on the risk management program known as iPledge.

The move does not reflect isotretinoin's safety or efficacy, said Dr. Stephen P. Stone, chairman of the American Academy of Dermatology's task force on retinoids. It appears that “this decision was financial and did not have anything to do with the perceived safety of the drug or the perceived willingness of dermatologists to use the drug,” said Dr. Stone in an interview.

In a statement, Roche noted that generic competitors now own the market for prescription isotretinoin. Accutane has less than a 5% share for the acne therapy, said the company.

The company “has been faced with high costs from personal injury lawsuits that the company continues to defend vigorously,” according to Roche.

Accutane was first marketed in 1982; the initial round of suits mostly alleged the drug was associated with a potential for depression and suicide. More recently, at least 500 suits have been filed alleging that Accutane causes irritable bowel disease.

The generic companies aren't likely to skirt future litigation, said Dr. Stone, a past AAD president and professor at Southern Illinois University School of Medicine in Carbondale.

A spokeswoman for one of the generic manufacturers, Barr Laboratories Inc., said that Barr intended to continue making and distributing isotretinoin.

Dr. Neil S. Goldberg, a dermatologist in Bronxville, N.Y., said in an interview that he agreed that plaintiffs' suits were likely to continue. But, he said, isotretinoin “is still a miracle drug” for acne and that he would not expect dermatologists to suddenly stop using it. He had already switched to using generic forms, partly because insurers made it less attractive for patients to use the brand, but also because he views them as largely equivalent, he said.

Dr. Stone, on the other hand, said he believed that iPledge had been responsive to dermatologists' complaints. He disclosed that he is on the scientific advisory board for iPledge.

Citing a significant loss of market share, Roche announced in June that it will cease manufacturing the retinoid Accutane, but dermatologists say that the company's pullout will not affect patients' access to the drug and will not have any impact on the risk management program known as iPledge.

The move does not reflect isotretinoin's safety or efficacy, said Dr. Stephen P. Stone, chairman of the American Academy of Dermatology's task force on retinoids. It appears that “this decision was financial and did not have anything to do with the perceived safety of the drug or the perceived willingness of dermatologists to use the drug,” said Dr. Stone in an interview.

In a statement, Roche noted that generic competitors now own the market for prescription isotretinoin. Accutane has less than a 5% share for the acne therapy, said the company.

The company “has been faced with high costs from personal injury lawsuits that the company continues to defend vigorously,” according to Roche.

Accutane was first marketed in 1982; the initial round of suits mostly alleged the drug was associated with a potential for depression and suicide. More recently, at least 500 suits have been filed alleging that Accutane causes irritable bowel disease.

The generic companies aren't likely to skirt future litigation, said Dr. Stone, a past AAD president and professor at Southern Illinois University School of Medicine in Carbondale.

A spokeswoman for one of the generic manufacturers, Barr Laboratories Inc., said that Barr intended to continue making and distributing isotretinoin.

Dr. Neil S. Goldberg, a dermatologist in Bronxville, N.Y., said in an interview that he agreed that plaintiffs' suits were likely to continue. But, he said, isotretinoin “is still a miracle drug” for acne and that he would not expect dermatologists to suddenly stop using it. He had already switched to using generic forms, partly because insurers made it less attractive for patients to use the brand, but also because he views them as largely equivalent, he said.

Dr. Stone, on the other hand, said he believed that iPledge had been responsive to dermatologists' complaints. He disclosed that he is on the scientific advisory board for iPledge.

Citing a significant loss of market share, Roche announced in June that it will cease manufacturing the retinoid Accutane, but dermatologists say that the company's pullout will not affect patients' access to the drug and will not have any impact on the risk management program known as iPledge.

The move does not reflect isotretinoin's safety or efficacy, said Dr. Stephen P. Stone, chairman of the American Academy of Dermatology's task force on retinoids. It appears that “this decision was financial and did not have anything to do with the perceived safety of the drug or the perceived willingness of dermatologists to use the drug,” said Dr. Stone in an interview.

In a statement, Roche noted that generic competitors now own the market for prescription isotretinoin. Accutane has less than a 5% share for the acne therapy, said the company.

The company “has been faced with high costs from personal injury lawsuits that the company continues to defend vigorously,” according to Roche.

Accutane was first marketed in 1982; the initial round of suits mostly alleged the drug was associated with a potential for depression and suicide. More recently, at least 500 suits have been filed alleging that Accutane causes irritable bowel disease.

The generic companies aren't likely to skirt future litigation, said Dr. Stone, a past AAD president and professor at Southern Illinois University School of Medicine in Carbondale.

A spokeswoman for one of the generic manufacturers, Barr Laboratories Inc., said that Barr intended to continue making and distributing isotretinoin.

Dr. Neil S. Goldberg, a dermatologist in Bronxville, N.Y., said in an interview that he agreed that plaintiffs' suits were likely to continue. But, he said, isotretinoin “is still a miracle drug” for acne and that he would not expect dermatologists to suddenly stop using it. He had already switched to using generic forms, partly because insurers made it less attractive for patients to use the brand, but also because he views them as largely equivalent, he said.

Dr. Stone, on the other hand, said he believed that iPledge had been responsive to dermatologists' complaints. He disclosed that he is on the scientific advisory board for iPledge.