Alicia Ault

President Obama signed legislation late on April 15 giving physicians another temporary reprieve from the 21% Medicare pay cut that, for all intents and purposes, was scheduled to go into effect at midnight.

The reduction in pay has now been deferred until June 1.

The fate of Medicare's physician fees was in doubt as late as the afternoon of the 15th. The Senate spent most of the week debating a bill (H.R. 4851) that would delay the cuts mandated by the Medicare Sustainable Growth Rate (SGR) formula as well as extend unemployment benefits and federal subsidies for COBRA benefits.

The Senate finally approved the bill, with the House doing so in quick succession. The President signed it shortly thereafter.

The Congressional Budget Office estimated the cost of this brief delay in the pay cuts at $2.1 billion, the second most costly aspect of the bill after unemployment benefits extension, at almost $12 billion.

The pay cut technically went into effect on April 1, but the Centers for Medicare and Medicaid Services (CMS) held all claims submitted from that date until April 15, in anticipation that Congress would reverse the cuts retroactively. But on the afternoon of the 15th, CMS officials noted in a statement that claims with dates of service on or after April 1 would be processed at the lower rate "as soon as systems are fully tested to ensure proper claims payment."

Physician groups were not pleased and began chiding members of Congress for their lack of action.

After the cut was delayed again, Dr. J. James Rohack, president of the American Medical Association, said in a statement, "Congress must now turn toward solving this problem once and for all through repeal of the broken payment formula that will hurt seniors, military families, and the physicians who care for them."

Dr. Rohack also warned--again--that physicians are starting to limit new Medicare patients.

"It is impossible for physicians to continue to care for all seniors when Medicare payments fall so far below the cost of providing care," he said, adding, "If the formula is not repealed, the problem will continue to grow."

President Obama signed legislation late on April 15 giving physicians another temporary reprieve from the 21% Medicare pay cut that, for all intents and purposes, was scheduled to go into effect at midnight.

The reduction in pay has now been deferred until June 1.

The fate of Medicare's physician fees was in doubt as late as the afternoon of the 15th. The Senate spent most of the week debating a bill (H.R. 4851) that would delay the cuts mandated by the Medicare Sustainable Growth Rate (SGR) formula as well as extend unemployment benefits and federal subsidies for COBRA benefits.

The Senate finally approved the bill, with the House doing so in quick succession. The President signed it shortly thereafter.

The Congressional Budget Office estimated the cost of this brief delay in the pay cuts at $2.1 billion, the second most costly aspect of the bill after unemployment benefits extension, at almost $12 billion.

The pay cut technically went into effect on April 1, but the Centers for Medicare and Medicaid Services (CMS) held all claims submitted from that date until April 15, in anticipation that Congress would reverse the cuts retroactively. But on the afternoon of the 15th, CMS officials noted in a statement that claims with dates of service on or after April 1 would be processed at the lower rate "as soon as systems are fully tested to ensure proper claims payment."

Physician groups were not pleased and began chiding members of Congress for their lack of action.

After the cut was delayed again, Dr. J. James Rohack, president of the American Medical Association, said in a statement, "Congress must now turn toward solving this problem once and for all through repeal of the broken payment formula that will hurt seniors, military families, and the physicians who care for them."

Dr. Rohack also warned--again--that physicians are starting to limit new Medicare patients.

"It is impossible for physicians to continue to care for all seniors when Medicare payments fall so far below the cost of providing care," he said, adding, "If the formula is not repealed, the problem will continue to grow."

President Obama signed legislation late on April 15 giving physicians another temporary reprieve from the 21% Medicare pay cut that, for all intents and purposes, was scheduled to go into effect at midnight.

The reduction in pay has now been deferred until June 1.

The fate of Medicare's physician fees was in doubt as late as the afternoon of the 15th. The Senate spent most of the week debating a bill (H.R. 4851) that would delay the cuts mandated by the Medicare Sustainable Growth Rate (SGR) formula as well as extend unemployment benefits and federal subsidies for COBRA benefits.

The Senate finally approved the bill, with the House doing so in quick succession. The President signed it shortly thereafter.

The Congressional Budget Office estimated the cost of this brief delay in the pay cuts at $2.1 billion, the second most costly aspect of the bill after unemployment benefits extension, at almost $12 billion.

The pay cut technically went into effect on April 1, but the Centers for Medicare and Medicaid Services (CMS) held all claims submitted from that date until April 15, in anticipation that Congress would reverse the cuts retroactively. But on the afternoon of the 15th, CMS officials noted in a statement that claims with dates of service on or after April 1 would be processed at the lower rate "as soon as systems are fully tested to ensure proper claims payment."

Physician groups were not pleased and began chiding members of Congress for their lack of action.

After the cut was delayed again, Dr. J. James Rohack, president of the American Medical Association, said in a statement, "Congress must now turn toward solving this problem once and for all through repeal of the broken payment formula that will hurt seniors, military families, and the physicians who care for them."

Dr. Rohack also warned--again--that physicians are starting to limit new Medicare patients.

"It is impossible for physicians to continue to care for all seniors when Medicare payments fall so far below the cost of providing care," he said, adding, "If the formula is not repealed, the problem will continue to grow."

A little-noticed provision of the new health reform law will allow physicians to use data that are collected and reported as part of the maintenance of certification process to be used as an alternative to the Medicare Physician Quality Reporting Initiative.

The details have yet to be worked out, but it would mean that physicians likely would have at least one fewer process to report quality data, said Dr. Christine Cassel, president and CEO of the American Board of Internal Medicine.

The advantage of the maintenance of certification (MOC) process is that physicians are familiar with it, as more than 80% of all physicians participate, Dr. Cassel said in an interview.

Physicians have been eligible to receive bonuses for participation in the Medicare PQRI, but they have complained about it as a redundant, burdensome, and confusing process, and have bemoaned botched or missing payments. Even the Centers for Medicare and Medicaid Services has acknowledged problems with the program.

In a statement, Dr. Kevin B. Weiss, president and CEO of the American Board of Medical Specialties, said that "MOC reporting will give patients, health plans, and others the information they need to choose physicians based on performance and other key qualifications, including diagnostic acumen, clinical reasoning, and medical knowledge. This [law] is a significant step forward in recognizing the value of MOC in advancing health care quality for the benefit of patients."

Under the Patient Protection and Affordable Care Act of 2010 - one of the two major health reform laws - the Health and Human Services secretary will decide how MOC will fit into the PQRI process. The hope is that this will be clarified within the year, ABIM's Dr. Cassel said.

ABIM and other medical specialty boards seek to meet with CMS officials to help write the regulations for implementing the process, she said. "Our concept is that it would be kind of an alternative pathway, … that it would include all the same conditions and measures as PQRI, but be even more comprehensive," said Dr. Cassel.

Family physicians already have some experience with using MOC as an alternative to PQRI. The American Board of Family Medicine received approval from Medicare to use its MOC registry for the PQRI process, according to Dr. Michael Hagen, ABFM's senior vice president. Instead of using Medicare "G" codes, physicians report actual patient data.

In 2008 (the first year of the registry), 260 family physicians participated. Participants could report on 15 patients over a 6-month period to receive half of the bonus, or 30 patients over a year to receive the full bonus, Dr. Hagen said in an interview. Last year, all participants were required to report on the full year; about 720 family physicians participated, he said.

Dr. Hagen said that he doesn't expect the ABFM process to change anytime soon. "Our PQRI process will continue as it is until we see the final rules and regulations" regarding implementation of the new law.

Dr. Hagen said that he envisions a future in which physicians can submit data for PQRI, for MOC, and for meaningful electronic health records in one fell swoop.

That will be a big relief, he said. As the three programs are currently structured, "nobody wants the same information in the same way, and it's just driving people nuts."

A little-noticed provision of the new health reform law will allow physicians to use data that are collected and reported as part of the maintenance of certification process to be used as an alternative to the Medicare Physician Quality Reporting Initiative.

The details have yet to be worked out, but it would mean that physicians likely would have at least one fewer process to report quality data, said Dr. Christine Cassel, president and CEO of the American Board of Internal Medicine.

The advantage of the maintenance of certification (MOC) process is that physicians are familiar with it, as more than 80% of all physicians participate, Dr. Cassel said in an interview.

Physicians have been eligible to receive bonuses for participation in the Medicare PQRI, but they have complained about it as a redundant, burdensome, and confusing process, and have bemoaned botched or missing payments. Even the Centers for Medicare and Medicaid Services has acknowledged problems with the program.

In a statement, Dr. Kevin B. Weiss, president and CEO of the American Board of Medical Specialties, said that "MOC reporting will give patients, health plans, and others the information they need to choose physicians based on performance and other key qualifications, including diagnostic acumen, clinical reasoning, and medical knowledge. This [law] is a significant step forward in recognizing the value of MOC in advancing health care quality for the benefit of patients."

Under the Patient Protection and Affordable Care Act of 2010 - one of the two major health reform laws - the Health and Human Services secretary will decide how MOC will fit into the PQRI process. The hope is that this will be clarified within the year, ABIM's Dr. Cassel said.

ABIM and other medical specialty boards seek to meet with CMS officials to help write the regulations for implementing the process, she said. "Our concept is that it would be kind of an alternative pathway, … that it would include all the same conditions and measures as PQRI, but be even more comprehensive," said Dr. Cassel.

Family physicians already have some experience with using MOC as an alternative to PQRI. The American Board of Family Medicine received approval from Medicare to use its MOC registry for the PQRI process, according to Dr. Michael Hagen, ABFM's senior vice president. Instead of using Medicare "G" codes, physicians report actual patient data.

In 2008 (the first year of the registry), 260 family physicians participated. Participants could report on 15 patients over a 6-month period to receive half of the bonus, or 30 patients over a year to receive the full bonus, Dr. Hagen said in an interview. Last year, all participants were required to report on the full year; about 720 family physicians participated, he said.

Dr. Hagen said that he doesn't expect the ABFM process to change anytime soon. "Our PQRI process will continue as it is until we see the final rules and regulations" regarding implementation of the new law.

Dr. Hagen said that he envisions a future in which physicians can submit data for PQRI, for MOC, and for meaningful electronic health records in one fell swoop.

That will be a big relief, he said. As the three programs are currently structured, "nobody wants the same information in the same way, and it's just driving people nuts."

A little-noticed provision of the new health reform law will allow physicians to use data that are collected and reported as part of the maintenance of certification process to be used as an alternative to the Medicare Physician Quality Reporting Initiative.

The details have yet to be worked out, but it would mean that physicians likely would have at least one fewer process to report quality data, said Dr. Christine Cassel, president and CEO of the American Board of Internal Medicine.

The advantage of the maintenance of certification (MOC) process is that physicians are familiar with it, as more than 80% of all physicians participate, Dr. Cassel said in an interview.

Physicians have been eligible to receive bonuses for participation in the Medicare PQRI, but they have complained about it as a redundant, burdensome, and confusing process, and have bemoaned botched or missing payments. Even the Centers for Medicare and Medicaid Services has acknowledged problems with the program.

In a statement, Dr. Kevin B. Weiss, president and CEO of the American Board of Medical Specialties, said that "MOC reporting will give patients, health plans, and others the information they need to choose physicians based on performance and other key qualifications, including diagnostic acumen, clinical reasoning, and medical knowledge. This [law] is a significant step forward in recognizing the value of MOC in advancing health care quality for the benefit of patients."

Under the Patient Protection and Affordable Care Act of 2010 - one of the two major health reform laws - the Health and Human Services secretary will decide how MOC will fit into the PQRI process. The hope is that this will be clarified within the year, ABIM's Dr. Cassel said.

ABIM and other medical specialty boards seek to meet with CMS officials to help write the regulations for implementing the process, she said. "Our concept is that it would be kind of an alternative pathway, … that it would include all the same conditions and measures as PQRI, but be even more comprehensive," said Dr. Cassel.

Family physicians already have some experience with using MOC as an alternative to PQRI. The American Board of Family Medicine received approval from Medicare to use its MOC registry for the PQRI process, according to Dr. Michael Hagen, ABFM's senior vice president. Instead of using Medicare "G" codes, physicians report actual patient data.

In 2008 (the first year of the registry), 260 family physicians participated. Participants could report on 15 patients over a 6-month period to receive half of the bonus, or 30 patients over a year to receive the full bonus, Dr. Hagen said in an interview. Last year, all participants were required to report on the full year; about 720 family physicians participated, he said.

Dr. Hagen said that he doesn't expect the ABFM process to change anytime soon. "Our PQRI process will continue as it is until we see the final rules and regulations" regarding implementation of the new law.

Dr. Hagen said that he envisions a future in which physicians can submit data for PQRI, for MOC, and for meaningful electronic health records in one fell swoop.

That will be a big relief, he said. As the three programs are currently structured, "nobody wants the same information in the same way, and it's just driving people nuts."

Saying that the cancer clinical trials system is in a state of crisis, an expert panel of the Institute of Medicine (IOM) called for an overhaul to speed up trial design and execution, incorporate scientific discoveries more rapidly, and create a structure to reimburse physicians and cover patients' costs for participation in studies.

In a report issued Apr. 15, the 17-member panel said the backbone of the system, the National Cancer Institute-supported Clinical Trials Cooperative Group Program, has become cumbersome and inefficient. According to the report, it takes an average two years to design, approve, and start a trial. Only half of trials are ever completed. And, while knowledge is exponentially increasing, the groups' funding has decreased by 20% over the last 8 years.

Moreover, enrollment in trials is abysmal. The American Cancer Society estimates that only 5% of adults with cancer participate.

"Cooperative group studies have steadily improved the care of cancer patients for more than 50 years, but the program is at a breaking point," said the IOM panel's chairman, Dr. John Mendelsohn, president of the University of Texas M.D. Anderson Cancer Center in Houston.
 
"The program urgently needs changes across the board, if it is going to continue producing the kind of studies necessary to answer crucial and fundamental questions about how to successfully treat and prevent cancer, which can't be answered through other means," he said.

The American Society of Clinical Oncologists (ASCO) applauded the IOM panel's recommendations. "The Cooperative Clinical Research Program is the jewel in our nation's cancer research system, and is critical to advancing progress against the disease," said Dr. Richard L. Schilsky, immediate past president of ASCO, in a statement.

The Cooperative Group Program, which is supported by the National Cancer Institute (NCI), comprises 10 groups that incorporate 3,100 institutions and 14,000 investigators. Some 25,000 patients participate in cooperative trials each year.

The IOM says that the groups have made important contributions over the half-century they have been in existence. For instance, largely as a result of findings from cooperative trials, pediatric cancer survival rates rose from 10% in the 1950s to 80% now, said the report.

Because the program does have the potential to be more efficient and effective, "it is imperative to preserve and strengthen the unique capabilities of the Cooperative Group Program as a vital component in NCI's translational continuum," wrote the panelists in the report.

It will be an uphill battle. Currently, funding for the groups makes up only 3% of the NCI's budget.

Dr. Schilsky said that "the system is being starved of funding." In real dollars, "the program receives less funding today than it did a decade ago," he noted.

"ASCO calls on NCI to double its support for cooperative clinical research within five years," said Dr. Schilsky, a professor of medicine and section chief, hematology/oncology at the University of Chicago Medical Center, who also served on the panel.

The IOM panel called for increased funding, but also urged changes that could be made without new money. It recommended an evaluation of the necessity and contributions of each group, and a shift by the NCI from oversight to pure facilitation of trials. The groups need to move beyond cooperation to "integration," said the report. That would include a consolidation of some front office and back office operations of the groups and improved collaboration among all the stakeholders.

The ability to recruit, train, and retain enough clinical investigators is also crucial to the rebuilding of the trial system, said the IOM panel. It recommended that health insurers, Medicare, and federal and state health programs cooperate to establish consistent payment policies to cover all patient care costs in a trial, except for the drugs, devices, or diagnostics, which should continue to be paid for by the manufacturers.

Such policies might act as an incentive for patients to participate in trials, said the panel.

The experts also urged the American Medical Association to create new current procedural terminology (CPT) codes that would create a payment pathway for offering, enrolling, managing, and following a patient through a clinical trial.

The new codes would reflect the additional time that physicians put in to getting patients into a trial, and for managing potential adverse events.
And, they would likely be a powerful incentive for physicians to consider putting more of their patients in studies, said the panel.

Physicians, indeed, are not happy about reimbursement. An ASCO survey released Apr. 15 showed that one-third of Cooperative Group Sites said they planned to limit participation in those trials due to inadequate per-case reimbursement. Almost 40% of those who were going to limit cooperative studies said they would instead increase their participation in industry-sponsored trials.

Saying that the cancer clinical trials system is in a state of crisis, an expert panel of the Institute of Medicine (IOM) called for an overhaul to speed up trial design and execution, incorporate scientific discoveries more rapidly, and create a structure to reimburse physicians and cover patients' costs for participation in studies.

In a report issued Apr. 15, the 17-member panel said the backbone of the system, the National Cancer Institute-supported Clinical Trials Cooperative Group Program, has become cumbersome and inefficient. According to the report, it takes an average two years to design, approve, and start a trial. Only half of trials are ever completed. And, while knowledge is exponentially increasing, the groups' funding has decreased by 20% over the last 8 years.

Moreover, enrollment in trials is abysmal. The American Cancer Society estimates that only 5% of adults with cancer participate.

"Cooperative group studies have steadily improved the care of cancer patients for more than 50 years, but the program is at a breaking point," said the IOM panel's chairman, Dr. John Mendelsohn, president of the University of Texas M.D. Anderson Cancer Center in Houston.
 
"The program urgently needs changes across the board, if it is going to continue producing the kind of studies necessary to answer crucial and fundamental questions about how to successfully treat and prevent cancer, which can't be answered through other means," he said.

The American Society of Clinical Oncologists (ASCO) applauded the IOM panel's recommendations. "The Cooperative Clinical Research Program is the jewel in our nation's cancer research system, and is critical to advancing progress against the disease," said Dr. Richard L. Schilsky, immediate past president of ASCO, in a statement.

The Cooperative Group Program, which is supported by the National Cancer Institute (NCI), comprises 10 groups that incorporate 3,100 institutions and 14,000 investigators. Some 25,000 patients participate in cooperative trials each year.

The IOM says that the groups have made important contributions over the half-century they have been in existence. For instance, largely as a result of findings from cooperative trials, pediatric cancer survival rates rose from 10% in the 1950s to 80% now, said the report.

Because the program does have the potential to be more efficient and effective, "it is imperative to preserve and strengthen the unique capabilities of the Cooperative Group Program as a vital component in NCI's translational continuum," wrote the panelists in the report.

It will be an uphill battle. Currently, funding for the groups makes up only 3% of the NCI's budget.

Dr. Schilsky said that "the system is being starved of funding." In real dollars, "the program receives less funding today than it did a decade ago," he noted.

"ASCO calls on NCI to double its support for cooperative clinical research within five years," said Dr. Schilsky, a professor of medicine and section chief, hematology/oncology at the University of Chicago Medical Center, who also served on the panel.

The IOM panel called for increased funding, but also urged changes that could be made without new money. It recommended an evaluation of the necessity and contributions of each group, and a shift by the NCI from oversight to pure facilitation of trials. The groups need to move beyond cooperation to "integration," said the report. That would include a consolidation of some front office and back office operations of the groups and improved collaboration among all the stakeholders.

The ability to recruit, train, and retain enough clinical investigators is also crucial to the rebuilding of the trial system, said the IOM panel. It recommended that health insurers, Medicare, and federal and state health programs cooperate to establish consistent payment policies to cover all patient care costs in a trial, except for the drugs, devices, or diagnostics, which should continue to be paid for by the manufacturers.

Such policies might act as an incentive for patients to participate in trials, said the panel.

The experts also urged the American Medical Association to create new current procedural terminology (CPT) codes that would create a payment pathway for offering, enrolling, managing, and following a patient through a clinical trial.

The new codes would reflect the additional time that physicians put in to getting patients into a trial, and for managing potential adverse events.
And, they would likely be a powerful incentive for physicians to consider putting more of their patients in studies, said the panel.

Physicians, indeed, are not happy about reimbursement. An ASCO survey released Apr. 15 showed that one-third of Cooperative Group Sites said they planned to limit participation in those trials due to inadequate per-case reimbursement. Almost 40% of those who were going to limit cooperative studies said they would instead increase their participation in industry-sponsored trials.

Saying that the cancer clinical trials system is in a state of crisis, an expert panel of the Institute of Medicine (IOM) called for an overhaul to speed up trial design and execution, incorporate scientific discoveries more rapidly, and create a structure to reimburse physicians and cover patients' costs for participation in studies.

In a report issued Apr. 15, the 17-member panel said the backbone of the system, the National Cancer Institute-supported Clinical Trials Cooperative Group Program, has become cumbersome and inefficient. According to the report, it takes an average two years to design, approve, and start a trial. Only half of trials are ever completed. And, while knowledge is exponentially increasing, the groups' funding has decreased by 20% over the last 8 years.

Moreover, enrollment in trials is abysmal. The American Cancer Society estimates that only 5% of adults with cancer participate.

"Cooperative group studies have steadily improved the care of cancer patients for more than 50 years, but the program is at a breaking point," said the IOM panel's chairman, Dr. John Mendelsohn, president of the University of Texas M.D. Anderson Cancer Center in Houston.
 
"The program urgently needs changes across the board, if it is going to continue producing the kind of studies necessary to answer crucial and fundamental questions about how to successfully treat and prevent cancer, which can't be answered through other means," he said.

The American Society of Clinical Oncologists (ASCO) applauded the IOM panel's recommendations. "The Cooperative Clinical Research Program is the jewel in our nation's cancer research system, and is critical to advancing progress against the disease," said Dr. Richard L. Schilsky, immediate past president of ASCO, in a statement.

The Cooperative Group Program, which is supported by the National Cancer Institute (NCI), comprises 10 groups that incorporate 3,100 institutions and 14,000 investigators. Some 25,000 patients participate in cooperative trials each year.

The IOM says that the groups have made important contributions over the half-century they have been in existence. For instance, largely as a result of findings from cooperative trials, pediatric cancer survival rates rose from 10% in the 1950s to 80% now, said the report.

Because the program does have the potential to be more efficient and effective, "it is imperative to preserve and strengthen the unique capabilities of the Cooperative Group Program as a vital component in NCI's translational continuum," wrote the panelists in the report.

It will be an uphill battle. Currently, funding for the groups makes up only 3% of the NCI's budget.

Dr. Schilsky said that "the system is being starved of funding." In real dollars, "the program receives less funding today than it did a decade ago," he noted.

"ASCO calls on NCI to double its support for cooperative clinical research within five years," said Dr. Schilsky, a professor of medicine and section chief, hematology/oncology at the University of Chicago Medical Center, who also served on the panel.

The IOM panel called for increased funding, but also urged changes that could be made without new money. It recommended an evaluation of the necessity and contributions of each group, and a shift by the NCI from oversight to pure facilitation of trials. The groups need to move beyond cooperation to "integration," said the report. That would include a consolidation of some front office and back office operations of the groups and improved collaboration among all the stakeholders.

The ability to recruit, train, and retain enough clinical investigators is also crucial to the rebuilding of the trial system, said the IOM panel. It recommended that health insurers, Medicare, and federal and state health programs cooperate to establish consistent payment policies to cover all patient care costs in a trial, except for the drugs, devices, or diagnostics, which should continue to be paid for by the manufacturers.

Such policies might act as an incentive for patients to participate in trials, said the panel.

The experts also urged the American Medical Association to create new current procedural terminology (CPT) codes that would create a payment pathway for offering, enrolling, managing, and following a patient through a clinical trial.

The new codes would reflect the additional time that physicians put in to getting patients into a trial, and for managing potential adverse events.
And, they would likely be a powerful incentive for physicians to consider putting more of their patients in studies, said the panel.

Physicians, indeed, are not happy about reimbursement. An ASCO survey released Apr. 15 showed that one-third of Cooperative Group Sites said they planned to limit participation in those trials due to inadequate per-case reimbursement. Almost 40% of those who were going to limit cooperative studies said they would instead increase their participation in industry-sponsored trials.

After 2 decades of debate, the Food and Drug Administration has issued a final rule declaring benzoyl peroxide to be safe and effective as an ingredient in over-the-counter topical acne products.

According to agency policy, benzoyl peroxide is now generally recognized as safe and effective. In 1991, the FDA proposed to classify the ingredient as a category III agent, which meant that it needed more study. There were data at that time suggesting that benzoyl peroxide was potentially carcinogenic in animals.

Over the years, though, new data have allayed the agency's concerns. “We now conclude that benzoyl peroxide can be adequately labeled to minimize the risks associated with benzoyl peroxide while delivering effective acne treatment,” the FDA noted in its final rule. However, the ingredient is still known to be a skin irritant and skin sensitizer, according to the agency.

The FDA is requiring new labeling on the cartons of products that contain benzoyl peroxide. The boxes will include warnings to avoid unnecessary sun exposure, to not use the product on very sensitive skin, and to keep the product away from the eyes, lips, and mouth. Consumers also will be cautioned that benzoyl peroxide can bleach hair or dye fabric. The label also will recommend that users wear a sunscreen.

After 2 decades of debate, the Food and Drug Administration has issued a final rule declaring benzoyl peroxide to be safe and effective as an ingredient in over-the-counter topical acne products.

According to agency policy, benzoyl peroxide is now generally recognized as safe and effective. In 1991, the FDA proposed to classify the ingredient as a category III agent, which meant that it needed more study. There were data at that time suggesting that benzoyl peroxide was potentially carcinogenic in animals.

Over the years, though, new data have allayed the agency's concerns. “We now conclude that benzoyl peroxide can be adequately labeled to minimize the risks associated with benzoyl peroxide while delivering effective acne treatment,” the FDA noted in its final rule. However, the ingredient is still known to be a skin irritant and skin sensitizer, according to the agency.

The FDA is requiring new labeling on the cartons of products that contain benzoyl peroxide. The boxes will include warnings to avoid unnecessary sun exposure, to not use the product on very sensitive skin, and to keep the product away from the eyes, lips, and mouth. Consumers also will be cautioned that benzoyl peroxide can bleach hair or dye fabric. The label also will recommend that users wear a sunscreen.

After 2 decades of debate, the Food and Drug Administration has issued a final rule declaring benzoyl peroxide to be safe and effective as an ingredient in over-the-counter topical acne products.

According to agency policy, benzoyl peroxide is now generally recognized as safe and effective. In 1991, the FDA proposed to classify the ingredient as a category III agent, which meant that it needed more study. There were data at that time suggesting that benzoyl peroxide was potentially carcinogenic in animals.

Over the years, though, new data have allayed the agency's concerns. “We now conclude that benzoyl peroxide can be adequately labeled to minimize the risks associated with benzoyl peroxide while delivering effective acne treatment,” the FDA noted in its final rule. However, the ingredient is still known to be a skin irritant and skin sensitizer, according to the agency.

The FDA is requiring new labeling on the cartons of products that contain benzoyl peroxide. The boxes will include warnings to avoid unnecessary sun exposure, to not use the product on very sensitive skin, and to keep the product away from the eyes, lips, and mouth. Consumers also will be cautioned that benzoyl peroxide can bleach hair or dye fabric. The label also will recommend that users wear a sunscreen.

The Food and Drug Administration announced April 7 that it sent warning letters to six medical spas and a Brazilian company asking them to cease and desist from making false and misleading claims about injectable lipodissolve products.

The companies cited by the FDA have made claims that their injectables are superior to other fat-dissolving or -removing procedures, and the injections can treat conditions such as gynecomastia and surgical deformities, said Kathleen Anderson, deputy director of the Division of New Drugs and Labeling Compliance at the FDA’s Center for Drug Evaluation and Research, in a briefing with reporters. The claims are illegal without clinical evidence or explicit FDA approval for the injectables, which generally contain phosphatidylcholine (PPC) and/or deoxycholate, and a variety of vitamins, minerals, and herbal extracts.

The letters were sent by overnight mail on April 5 to six American spas: Monarch Medspa, King of Prussia, Penn.; Spa 35, Boise, Idaho; Medical Cosmetic Enhancements, Chevy Chase, Md.; Innovative Directions in Health, Edina, Minn.; Pure Med Spa, Boca Raton, Fla.; and All About You Med Spa, Madison, Ind.

The Brazilian company cited by the FDA sells lipodissolve products through its two Web sites www.zipmed.net and www.mesoone.com. The agency has issued an import alert for the Web sites, which should prevent the importation and distribution of the products.

Ms. Anderson said the companies were singled out because they had made what were considered to be the most egregious claims among the sites the FDA has monitored.

The agency is hoping to warn consumers that if they purchase these services, they are receiving therapies that are not approved by the FDA, she said. In addition, the drug components—PPC and deoxycholate—are not specifically approved as injectables or for fat dissolution. They are approved for inhalation as a lung surfactant in acute respiratory distress syndrome, said Ms. Anderson.

A complete list of concerns about lipodissolve, also known as mesotherapy or injectable lipolysis, can be found on an updated page for consumers on the FDA Web site. Among the safety concerns are permanent scarring, skin deformation, and painful knots under the skin. The agency has received five reports of such adverse events, Ms. Anderson said.

The FDA also said that clinicians who are using lipodissolve products should submit an application for approval so the agency can evaluate safety and efficacy. The Aesthetic Surgery Education and Research Foundation is conducting a small, placebo-controlled study using sham injections, compared with injections of PPC and sodium deoxycholate. The FDA has approved the study.

But most professional societies, including the Physicians Coalition for Injectable Safety, the American Society for Aesthetic Plastic Surgery (ASAPS), and the American Society for Dermatologic Surgery, have warned against fat-dissolving injections until there is further proof of efficacy and safety.

The FDA, for its part, said it would be monitoring further use of lipodissolve, whether by unlicensed practitioners or physicians. “If there are clinics and medical practices that are going to be making false and misleading claims, then we will go after them as well,” said Sudha Shukla, Pharm. D., of the FDA’s Division of New Drugs and Labeling Compliance, during the briefing.

It is not clear how many lipodissolve procedures are done each year. The ASAPS reported that 18,000 were done in 2008, but that an insufficient number of clinicians responded to its annual survey in 2009 to give a reliable number.

The companies cited by the FDA have 15 days to respond to the agency’s warning. If sufficient steps are not taken, then the agency has the power to issue an injunction or seize products, said Ms. Anderson.

The Food and Drug Administration announced April 7 that it sent warning letters to six medical spas and a Brazilian company asking them to cease and desist from making false and misleading claims about injectable lipodissolve products.

The companies cited by the FDA have made claims that their injectables are superior to other fat-dissolving or -removing procedures, and the injections can treat conditions such as gynecomastia and surgical deformities, said Kathleen Anderson, deputy director of the Division of New Drugs and Labeling Compliance at the FDA’s Center for Drug Evaluation and Research, in a briefing with reporters. The claims are illegal without clinical evidence or explicit FDA approval for the injectables, which generally contain phosphatidylcholine (PPC) and/or deoxycholate, and a variety of vitamins, minerals, and herbal extracts.

The letters were sent by overnight mail on April 5 to six American spas: Monarch Medspa, King of Prussia, Penn.; Spa 35, Boise, Idaho; Medical Cosmetic Enhancements, Chevy Chase, Md.; Innovative Directions in Health, Edina, Minn.; Pure Med Spa, Boca Raton, Fla.; and All About You Med Spa, Madison, Ind.

The Brazilian company cited by the FDA sells lipodissolve products through its two Web sites www.zipmed.net and www.mesoone.com. The agency has issued an import alert for the Web sites, which should prevent the importation and distribution of the products.

Ms. Anderson said the companies were singled out because they had made what were considered to be the most egregious claims among the sites the FDA has monitored.

The agency is hoping to warn consumers that if they purchase these services, they are receiving therapies that are not approved by the FDA, she said. In addition, the drug components—PPC and deoxycholate—are not specifically approved as injectables or for fat dissolution. They are approved for inhalation as a lung surfactant in acute respiratory distress syndrome, said Ms. Anderson.

A complete list of concerns about lipodissolve, also known as mesotherapy or injectable lipolysis, can be found on an updated page for consumers on the FDA Web site. Among the safety concerns are permanent scarring, skin deformation, and painful knots under the skin. The agency has received five reports of such adverse events, Ms. Anderson said.

The FDA also said that clinicians who are using lipodissolve products should submit an application for approval so the agency can evaluate safety and efficacy. The Aesthetic Surgery Education and Research Foundation is conducting a small, placebo-controlled study using sham injections, compared with injections of PPC and sodium deoxycholate. The FDA has approved the study.

But most professional societies, including the Physicians Coalition for Injectable Safety, the American Society for Aesthetic Plastic Surgery (ASAPS), and the American Society for Dermatologic Surgery, have warned against fat-dissolving injections until there is further proof of efficacy and safety.

The FDA, for its part, said it would be monitoring further use of lipodissolve, whether by unlicensed practitioners or physicians. “If there are clinics and medical practices that are going to be making false and misleading claims, then we will go after them as well,” said Sudha Shukla, Pharm. D., of the FDA’s Division of New Drugs and Labeling Compliance, during the briefing.

It is not clear how many lipodissolve procedures are done each year. The ASAPS reported that 18,000 were done in 2008, but that an insufficient number of clinicians responded to its annual survey in 2009 to give a reliable number.

The companies cited by the FDA have 15 days to respond to the agency’s warning. If sufficient steps are not taken, then the agency has the power to issue an injunction or seize products, said Ms. Anderson.

The Food and Drug Administration announced April 7 that it sent warning letters to six medical spas and a Brazilian company asking them to cease and desist from making false and misleading claims about injectable lipodissolve products.

The companies cited by the FDA have made claims that their injectables are superior to other fat-dissolving or -removing procedures, and the injections can treat conditions such as gynecomastia and surgical deformities, said Kathleen Anderson, deputy director of the Division of New Drugs and Labeling Compliance at the FDA’s Center for Drug Evaluation and Research, in a briefing with reporters. The claims are illegal without clinical evidence or explicit FDA approval for the injectables, which generally contain phosphatidylcholine (PPC) and/or deoxycholate, and a variety of vitamins, minerals, and herbal extracts.

The letters were sent by overnight mail on April 5 to six American spas: Monarch Medspa, King of Prussia, Penn.; Spa 35, Boise, Idaho; Medical Cosmetic Enhancements, Chevy Chase, Md.; Innovative Directions in Health, Edina, Minn.; Pure Med Spa, Boca Raton, Fla.; and All About You Med Spa, Madison, Ind.

The Brazilian company cited by the FDA sells lipodissolve products through its two Web sites www.zipmed.net and www.mesoone.com. The agency has issued an import alert for the Web sites, which should prevent the importation and distribution of the products.

Ms. Anderson said the companies were singled out because they had made what were considered to be the most egregious claims among the sites the FDA has monitored.

The agency is hoping to warn consumers that if they purchase these services, they are receiving therapies that are not approved by the FDA, she said. In addition, the drug components—PPC and deoxycholate—are not specifically approved as injectables or for fat dissolution. They are approved for inhalation as a lung surfactant in acute respiratory distress syndrome, said Ms. Anderson.

A complete list of concerns about lipodissolve, also known as mesotherapy or injectable lipolysis, can be found on an updated page for consumers on the FDA Web site. Among the safety concerns are permanent scarring, skin deformation, and painful knots under the skin. The agency has received five reports of such adverse events, Ms. Anderson said.

The FDA also said that clinicians who are using lipodissolve products should submit an application for approval so the agency can evaluate safety and efficacy. The Aesthetic Surgery Education and Research Foundation is conducting a small, placebo-controlled study using sham injections, compared with injections of PPC and sodium deoxycholate. The FDA has approved the study.

But most professional societies, including the Physicians Coalition for Injectable Safety, the American Society for Aesthetic Plastic Surgery (ASAPS), and the American Society for Dermatologic Surgery, have warned against fat-dissolving injections until there is further proof of efficacy and safety.

The FDA, for its part, said it would be monitoring further use of lipodissolve, whether by unlicensed practitioners or physicians. “If there are clinics and medical practices that are going to be making false and misleading claims, then we will go after them as well,” said Sudha Shukla, Pharm. D., of the FDA’s Division of New Drugs and Labeling Compliance, during the briefing.

It is not clear how many lipodissolve procedures are done each year. The ASAPS reported that 18,000 were done in 2008, but that an insufficient number of clinicians responded to its annual survey in 2009 to give a reliable number.

The companies cited by the FDA have 15 days to respond to the agency’s warning. If sufficient steps are not taken, then the agency has the power to issue an injunction or seize products, said Ms. Anderson.

A new advocacy coalition is putting pressure on the Accreditation Council for Graduate Medical Education to speed up its process of developing new recommendations on work hour restrictions for residents—and to closely follow the Institute of Medicine's recommendations by further reducing hours.

The coalition, led by Public Citizen, sent a letter to Dr. Thomas J. Nasca, ACGME's executive director, urging the accrediting body to adopt rules that aim to reduce sleep deprivation and to better protect patients, Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, said in a briefing with reporters.

“The available evidence suggests that the public is deeply concerned about the current work hours of medical residents,” stated the letter, which is posted at www.wakeupdoctor.org

At the briefing, Dr. John Ingell, a fourth-year surgical resident at the University of New Mexico, Albuquerque, said that he became less compassionate when severely fatigued. Concentration also suffered, said Dr. Ingell, who is on the board of the Service Employees International Union's medical resident section.

Dan Henderson, a third-year medical student at the University of Connecticut, Farmington, said that at the time, he was proud to work 12 hours or more a day or a 30-hour continuous shift on his surgical rotation. Now, he feels “ashamed,” because he has realized that such efforts did not improve his education and had a negative effect on his feelings for patients.

He said he supported the limit on work hours recommended by the IOM in 2008. The IOM urged a reduction from 30-hour shifts to shifts no longer than 16 hours. “I really think medicine needs a wake- up call and needs to move into the 21st century,” said Mr. Henderson.

The ACGME had planned on reviewing the work hours 5 years after they were first reduced, which happened to coincide with the IOM's report, Dr. Nasca said in an interview. The 16-member Duty Hours Task Force has been meeting since last July. New draft standards are likely to be issued by late April, and then available for public comment for 45 days, he said.

At the briefing, Dr. Charles A. Czeisler, professor of sleep medicine at Harvard Medical School, Boston, said that the current ACGME standards are widely flouted. Confidential surveys of residents have shown “widespread falsification” by trainees on their actual work hours, he noted.

Dr. Nasca responded that the ACGME is an educational accreditor, “not an employment regulator…. Our goal is to ensure substantial compliance with the regulations.”

There is a tension between the educational mission, safety, and other factors, acknowledged Dr. Nasca, adding that this is why the Duty Hours Task Force had gathered evidence and opinions from more than 140 organizations.

“There's a constant balance we have to take between setting realistic expectations for how residents are scheduled for duty and the expectations that programs comply with those, coupled with the desire to inculcate in physicians a sense of personal responsibility for the safety and care of each individual patient,” said Dr. Nasca.

The risk of fatigue also has to be balanced against the risk of increased errors when patients are handed off to an increasing number of caregivers, he said.

A new advocacy coalition is putting pressure on the Accreditation Council for Graduate Medical Education to speed up its process of developing new recommendations on work hour restrictions for residents—and to closely follow the Institute of Medicine's recommendations by further reducing hours.

The coalition, led by Public Citizen, sent a letter to Dr. Thomas J. Nasca, ACGME's executive director, urging the accrediting body to adopt rules that aim to reduce sleep deprivation and to better protect patients, Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, said in a briefing with reporters.

“The available evidence suggests that the public is deeply concerned about the current work hours of medical residents,” stated the letter, which is posted at www.wakeupdoctor.org

At the briefing, Dr. John Ingell, a fourth-year surgical resident at the University of New Mexico, Albuquerque, said that he became less compassionate when severely fatigued. Concentration also suffered, said Dr. Ingell, who is on the board of the Service Employees International Union's medical resident section.

Dan Henderson, a third-year medical student at the University of Connecticut, Farmington, said that at the time, he was proud to work 12 hours or more a day or a 30-hour continuous shift on his surgical rotation. Now, he feels “ashamed,” because he has realized that such efforts did not improve his education and had a negative effect on his feelings for patients.

He said he supported the limit on work hours recommended by the IOM in 2008. The IOM urged a reduction from 30-hour shifts to shifts no longer than 16 hours. “I really think medicine needs a wake- up call and needs to move into the 21st century,” said Mr. Henderson.

The ACGME had planned on reviewing the work hours 5 years after they were first reduced, which happened to coincide with the IOM's report, Dr. Nasca said in an interview. The 16-member Duty Hours Task Force has been meeting since last July. New draft standards are likely to be issued by late April, and then available for public comment for 45 days, he said.

At the briefing, Dr. Charles A. Czeisler, professor of sleep medicine at Harvard Medical School, Boston, said that the current ACGME standards are widely flouted. Confidential surveys of residents have shown “widespread falsification” by trainees on their actual work hours, he noted.

Dr. Nasca responded that the ACGME is an educational accreditor, “not an employment regulator…. Our goal is to ensure substantial compliance with the regulations.”

There is a tension between the educational mission, safety, and other factors, acknowledged Dr. Nasca, adding that this is why the Duty Hours Task Force had gathered evidence and opinions from more than 140 organizations.

“There's a constant balance we have to take between setting realistic expectations for how residents are scheduled for duty and the expectations that programs comply with those, coupled with the desire to inculcate in physicians a sense of personal responsibility for the safety and care of each individual patient,” said Dr. Nasca.

The risk of fatigue also has to be balanced against the risk of increased errors when patients are handed off to an increasing number of caregivers, he said.

A new advocacy coalition is putting pressure on the Accreditation Council for Graduate Medical Education to speed up its process of developing new recommendations on work hour restrictions for residents—and to closely follow the Institute of Medicine's recommendations by further reducing hours.

The coalition, led by Public Citizen, sent a letter to Dr. Thomas J. Nasca, ACGME's executive director, urging the accrediting body to adopt rules that aim to reduce sleep deprivation and to better protect patients, Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, said in a briefing with reporters.

“The available evidence suggests that the public is deeply concerned about the current work hours of medical residents,” stated the letter, which is posted at www.wakeupdoctor.org

At the briefing, Dr. John Ingell, a fourth-year surgical resident at the University of New Mexico, Albuquerque, said that he became less compassionate when severely fatigued. Concentration also suffered, said Dr. Ingell, who is on the board of the Service Employees International Union's medical resident section.

Dan Henderson, a third-year medical student at the University of Connecticut, Farmington, said that at the time, he was proud to work 12 hours or more a day or a 30-hour continuous shift on his surgical rotation. Now, he feels “ashamed,” because he has realized that such efforts did not improve his education and had a negative effect on his feelings for patients.

He said he supported the limit on work hours recommended by the IOM in 2008. The IOM urged a reduction from 30-hour shifts to shifts no longer than 16 hours. “I really think medicine needs a wake- up call and needs to move into the 21st century,” said Mr. Henderson.

The ACGME had planned on reviewing the work hours 5 years after they were first reduced, which happened to coincide with the IOM's report, Dr. Nasca said in an interview. The 16-member Duty Hours Task Force has been meeting since last July. New draft standards are likely to be issued by late April, and then available for public comment for 45 days, he said.

At the briefing, Dr. Charles A. Czeisler, professor of sleep medicine at Harvard Medical School, Boston, said that the current ACGME standards are widely flouted. Confidential surveys of residents have shown “widespread falsification” by trainees on their actual work hours, he noted.

Dr. Nasca responded that the ACGME is an educational accreditor, “not an employment regulator…. Our goal is to ensure substantial compliance with the regulations.”

There is a tension between the educational mission, safety, and other factors, acknowledged Dr. Nasca, adding that this is why the Duty Hours Task Force had gathered evidence and opinions from more than 140 organizations.

“There's a constant balance we have to take between setting realistic expectations for how residents are scheduled for duty and the expectations that programs comply with those, coupled with the desire to inculcate in physicians a sense of personal responsibility for the safety and care of each individual patient,” said Dr. Nasca.

The risk of fatigue also has to be balanced against the risk of increased errors when patients are handed off to an increasing number of caregivers, he said.

A new advocacy coalition is putting pressure on the Accreditation Council for Graduate Medical Education to speed up its process of developing new recommendations on work hour restrictions for residents, and to closely follow the Institute of Medicine's recommendations by further reducing hours.

The coalition, led by Public Citizen, sent a letter to Dr. Thomas J. Nasca, ACGME's executive director, urging the accrediting body to adopt rules that aim to reduce sleep deprivation and to better protect patients, Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, said in a briefing with reporters. “The available evidence suggests that the public is deeply concerned about the current work hours of medical residents,” as stated in the letter to Dr. Nasca. The letter is posted at www.wakeupdoctor.org

At the briefing, Dr. John Ingell, a surgical resident at the University of New Mexico, Albuquerque, said that he noticed he became less compassionate when severely fatigued. Concentration also suffered, said Dr. Ingell, who is on the board of the Service Employees International Union's medical resident section.

Dan Henderson, a medical student at the University of Connecticut, Farmington, said that at the time, he was proud to work 12 hours or more a day or a 30-hour continuous shift on his surgical rotation. Now, he feels “ashamed,” because he realizes that such efforts did not improve his education and also had a negative effect on his feelings for patients.

He said he supported the limit on work hours recommended by the IOM in 2008. The IOM urged a reduction from 30-hour shifts to shifts lasting no longer than 16 hours. “I really think medicine needs a wake-up call and needs to move into the 21st century,” said Mr. Henderson.

The ACGME had planned on reviewing the work hours 5 years after they were first reduced, which happened to coincide with the IOM's report, said Dr. Nasca in an interview. The 16-member Duty Hours Task Force has been meeting since last July. New draft standards are likely to be issued by late April, and will then be available for public comment for 45 days, he said.

At the briefing, Dr. Charles A. Czeisler, professor of sleep medicine at Harvard Medical School, Boston, said that the current ACGME standards are widely flouted. He said confidential surveys of residents have shown “widespread falsification” by trainees on their actual work hours. Dr. Nasca responded that his organization was an educational accreditor, “not an employment regulator.”

Added Dr. Nasca, “Our goal is to ensure substantial compliance with the regulations.”

There is a tension between the educational mission, safety, and other factors, acknowledged Dr. Nasca, adding that this is why the Duty Hours Task Force had gathered evidence and opinions from more than 140 organizations.

“There's a constant balance we have to take between setting realistic expectations for how residents are scheduled for duty and the expectations that programs comply with those, coupled with the desire to inculcate in physicians a sense of personal responsibility for the safety and care of each individual patient,” said Dr. Nasca.

The risk of fatigue also has to be balanced against the risk of increased errors when patients are handed off to an increasing number of caregivers, he said. The evidence is conflicting on whether reduced work hours improves patient safety, added Dr. Nasca.

However, he said he welcomed the new group's attention to work hours. “This is an important issue for the public to understand,” Dr. Nasca said.

A new advocacy coalition is putting pressure on the Accreditation Council for Graduate Medical Education to speed up its process of developing new recommendations on work hour restrictions for residents, and to closely follow the Institute of Medicine's recommendations by further reducing hours.

The coalition, led by Public Citizen, sent a letter to Dr. Thomas J. Nasca, ACGME's executive director, urging the accrediting body to adopt rules that aim to reduce sleep deprivation and to better protect patients, Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, said in a briefing with reporters. “The available evidence suggests that the public is deeply concerned about the current work hours of medical residents,” as stated in the letter to Dr. Nasca. The letter is posted at www.wakeupdoctor.org

At the briefing, Dr. John Ingell, a surgical resident at the University of New Mexico, Albuquerque, said that he noticed he became less compassionate when severely fatigued. Concentration also suffered, said Dr. Ingell, who is on the board of the Service Employees International Union's medical resident section.

Dan Henderson, a medical student at the University of Connecticut, Farmington, said that at the time, he was proud to work 12 hours or more a day or a 30-hour continuous shift on his surgical rotation. Now, he feels “ashamed,” because he realizes that such efforts did not improve his education and also had a negative effect on his feelings for patients.

He said he supported the limit on work hours recommended by the IOM in 2008. The IOM urged a reduction from 30-hour shifts to shifts lasting no longer than 16 hours. “I really think medicine needs a wake-up call and needs to move into the 21st century,” said Mr. Henderson.

The ACGME had planned on reviewing the work hours 5 years after they were first reduced, which happened to coincide with the IOM's report, said Dr. Nasca in an interview. The 16-member Duty Hours Task Force has been meeting since last July. New draft standards are likely to be issued by late April, and will then be available for public comment for 45 days, he said.

At the briefing, Dr. Charles A. Czeisler, professor of sleep medicine at Harvard Medical School, Boston, said that the current ACGME standards are widely flouted. He said confidential surveys of residents have shown “widespread falsification” by trainees on their actual work hours. Dr. Nasca responded that his organization was an educational accreditor, “not an employment regulator.”

Added Dr. Nasca, “Our goal is to ensure substantial compliance with the regulations.”

There is a tension between the educational mission, safety, and other factors, acknowledged Dr. Nasca, adding that this is why the Duty Hours Task Force had gathered evidence and opinions from more than 140 organizations.

“There's a constant balance we have to take between setting realistic expectations for how residents are scheduled for duty and the expectations that programs comply with those, coupled with the desire to inculcate in physicians a sense of personal responsibility for the safety and care of each individual patient,” said Dr. Nasca.

The risk of fatigue also has to be balanced against the risk of increased errors when patients are handed off to an increasing number of caregivers, he said. The evidence is conflicting on whether reduced work hours improves patient safety, added Dr. Nasca.

However, he said he welcomed the new group's attention to work hours. “This is an important issue for the public to understand,” Dr. Nasca said.

A new advocacy coalition is putting pressure on the Accreditation Council for Graduate Medical Education to speed up its process of developing new recommendations on work hour restrictions for residents, and to closely follow the Institute of Medicine's recommendations by further reducing hours.

The coalition, led by Public Citizen, sent a letter to Dr. Thomas J. Nasca, ACGME's executive director, urging the accrediting body to adopt rules that aim to reduce sleep deprivation and to better protect patients, Dr. Sidney Wolfe, director of Public Citizen's Health Research Group, said in a briefing with reporters. “The available evidence suggests that the public is deeply concerned about the current work hours of medical residents,” as stated in the letter to Dr. Nasca. The letter is posted at www.wakeupdoctor.org

At the briefing, Dr. John Ingell, a surgical resident at the University of New Mexico, Albuquerque, said that he noticed he became less compassionate when severely fatigued. Concentration also suffered, said Dr. Ingell, who is on the board of the Service Employees International Union's medical resident section.

Dan Henderson, a medical student at the University of Connecticut, Farmington, said that at the time, he was proud to work 12 hours or more a day or a 30-hour continuous shift on his surgical rotation. Now, he feels “ashamed,” because he realizes that such efforts did not improve his education and also had a negative effect on his feelings for patients.

He said he supported the limit on work hours recommended by the IOM in 2008. The IOM urged a reduction from 30-hour shifts to shifts lasting no longer than 16 hours. “I really think medicine needs a wake-up call and needs to move into the 21st century,” said Mr. Henderson.

The ACGME had planned on reviewing the work hours 5 years after they were first reduced, which happened to coincide with the IOM's report, said Dr. Nasca in an interview. The 16-member Duty Hours Task Force has been meeting since last July. New draft standards are likely to be issued by late April, and will then be available for public comment for 45 days, he said.

At the briefing, Dr. Charles A. Czeisler, professor of sleep medicine at Harvard Medical School, Boston, said that the current ACGME standards are widely flouted. He said confidential surveys of residents have shown “widespread falsification” by trainees on their actual work hours. Dr. Nasca responded that his organization was an educational accreditor, “not an employment regulator.”

Added Dr. Nasca, “Our goal is to ensure substantial compliance with the regulations.”

There is a tension between the educational mission, safety, and other factors, acknowledged Dr. Nasca, adding that this is why the Duty Hours Task Force had gathered evidence and opinions from more than 140 organizations.

“There's a constant balance we have to take between setting realistic expectations for how residents are scheduled for duty and the expectations that programs comply with those, coupled with the desire to inculcate in physicians a sense of personal responsibility for the safety and care of each individual patient,” said Dr. Nasca.

The risk of fatigue also has to be balanced against the risk of increased errors when patients are handed off to an increasing number of caregivers, he said. The evidence is conflicting on whether reduced work hours improves patient safety, added Dr. Nasca.

However, he said he welcomed the new group's attention to work hours. “This is an important issue for the public to understand,” Dr. Nasca said.

The Centers for Medicare and Medicaid Services has named the national accrediting organizations charged with oversight of physician and nonphysician organizations that provide computed tomography, magnetic resonance imaging, positron emission tomography, and nuclear medicine exams under the technical component of the Medicare Fee Schedule.

The American College of Radiology (ACR), the Intersocietal Accreditation Commission (IAC), and the Joint Commission will furnish accreditation services and report back to the CMS on their survey processes.

The Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) requires that all suppliers of advanced imaging become accredited by Jan. 1, 2012.

“The three organizations that will be accrediting suppliers have the expertise and authority to set a standard of excellence industry-wide,” Dr. Barry Straube, chief medical officer of the CMS, said in a statement announcing the selection of the accrediting bodies.

The groups will be responsible for judging and verifying the qualifications of nonphysician personnel who perform the imaging as well as the qualifications of medical directors and supervising physicians; checking safety procedures; verifying procedures to ensure reliability, clarity, and accuracy of imaging; and checking procedures to help patients obtain imaging studies upon request.

Providers of x-rays, ultrasound, and fluoroscopy will not be subject to the accreditation process.

The American College of Cardiology will be working with members to make sure they understand the accreditation requirements, said an ACC spokesperson. The professional society is working closely with the IAC, but cardiologists are free to choose any of the three accrediting organizations, she said.

Rheumatologist Norman B. Gaylis applauded the required certification of other imaging used in the office setting. “This action is not punitive. It is intended to achieve quality,” said Dr. Gaylis, Aventura, Fla., who is in president and a founding member of the International Society of Extremity MRI in Rheumatology.

The certification process may increase payers' willingness to reimburse for office-based imaging. Furthermore, it gives patients the assurance that the staff and equipment have met accrediting standards, he added.

Office-based MRI has been exempt from certification requirements. However, that will end in January 2012, when all physician offices that use MRI will have to be accredited to do so.

The Centers for Medicare and Medicaid Services has named the national accrediting organizations charged with oversight of physician and nonphysician organizations that provide computed tomography, magnetic resonance imaging, positron emission tomography, and nuclear medicine exams under the technical component of the Medicare Fee Schedule.

The American College of Radiology (ACR), the Intersocietal Accreditation Commission (IAC), and the Joint Commission will furnish accreditation services and report back to the CMS on their survey processes.

The Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) requires that all suppliers of advanced imaging become accredited by Jan. 1, 2012.

“The three organizations that will be accrediting suppliers have the expertise and authority to set a standard of excellence industry-wide,” Dr. Barry Straube, chief medical officer of the CMS, said in a statement announcing the selection of the accrediting bodies.

The groups will be responsible for judging and verifying the qualifications of nonphysician personnel who perform the imaging as well as the qualifications of medical directors and supervising physicians; checking safety procedures; verifying procedures to ensure reliability, clarity, and accuracy of imaging; and checking procedures to help patients obtain imaging studies upon request.

Providers of x-rays, ultrasound, and fluoroscopy will not be subject to the accreditation process.

The American College of Cardiology will be working with members to make sure they understand the accreditation requirements, said an ACC spokesperson. The professional society is working closely with the IAC, but cardiologists are free to choose any of the three accrediting organizations, she said.

Rheumatologist Norman B. Gaylis applauded the required certification of other imaging used in the office setting. “This action is not punitive. It is intended to achieve quality,” said Dr. Gaylis, Aventura, Fla., who is in president and a founding member of the International Society of Extremity MRI in Rheumatology.

The certification process may increase payers' willingness to reimburse for office-based imaging. Furthermore, it gives patients the assurance that the staff and equipment have met accrediting standards, he added.

Office-based MRI has been exempt from certification requirements. However, that will end in January 2012, when all physician offices that use MRI will have to be accredited to do so.

The Centers for Medicare and Medicaid Services has named the national accrediting organizations charged with oversight of physician and nonphysician organizations that provide computed tomography, magnetic resonance imaging, positron emission tomography, and nuclear medicine exams under the technical component of the Medicare Fee Schedule.

The American College of Radiology (ACR), the Intersocietal Accreditation Commission (IAC), and the Joint Commission will furnish accreditation services and report back to the CMS on their survey processes.

The Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) requires that all suppliers of advanced imaging become accredited by Jan. 1, 2012.

“The three organizations that will be accrediting suppliers have the expertise and authority to set a standard of excellence industry-wide,” Dr. Barry Straube, chief medical officer of the CMS, said in a statement announcing the selection of the accrediting bodies.

The groups will be responsible for judging and verifying the qualifications of nonphysician personnel who perform the imaging as well as the qualifications of medical directors and supervising physicians; checking safety procedures; verifying procedures to ensure reliability, clarity, and accuracy of imaging; and checking procedures to help patients obtain imaging studies upon request.

Providers of x-rays, ultrasound, and fluoroscopy will not be subject to the accreditation process.

The American College of Cardiology will be working with members to make sure they understand the accreditation requirements, said an ACC spokesperson. The professional society is working closely with the IAC, but cardiologists are free to choose any of the three accrediting organizations, she said.

Rheumatologist Norman B. Gaylis applauded the required certification of other imaging used in the office setting. “This action is not punitive. It is intended to achieve quality,” said Dr. Gaylis, Aventura, Fla., who is in president and a founding member of the International Society of Extremity MRI in Rheumatology.

The certification process may increase payers' willingness to reimburse for office-based imaging. Furthermore, it gives patients the assurance that the staff and equipment have met accrediting standards, he added.

Office-based MRI has been exempt from certification requirements. However, that will end in January 2012, when all physician offices that use MRI will have to be accredited to do so.

The Food and Drug Administration updated the labeling for clopidogrel to emphasize that new data definitively shows that the drug is less effective—and may not work at all—in patients defined as “poor metabolizers.”

The agency is notifying physicians that testing is available for the genotypes that are associated with poor metabolism, but it stopped short of recommending that all patients receive such testing before starting a course of clopidogrel (Plavix).

About 2%-14% of the population probably have those alleles and are poor metabolizers, with the rate varying by racial background, according to the FDA.

The issue of reduced metabolism was first highlighted in the clopidogrel label in May 2009. But the agency decided to add a stronger, boxed warning to clopidogrel because of the mounting evidence about poor metabolizers, including a required postmarketing study conducted by the drug's manufacturer, Sanofi-Aventis, that was submitted to the FDA, said Mary Ross Southworth, Pharm. D., a clinical analyst in the Division of Cardiovascular and Renal Products in the FDA's Center for Drug Evaluation and Research, in a briefing with reporters.

That 40-patient study confirmed that patients with the *2 and *3 alleles of the CYP2C19 liver enzyme were likely to be poor metabolizers. The *4, *5, *6, *7 and *8 alleles are associated with little to no metabolism of clopidogrel but occur less commonly than *2 and *3 alleles.

In acute situations, such as during a MI or coronary angioplasty, waiting for test results won't be reasonable, said Dr. Robert Temple, deputy director for clinical science in FDA's Center for Drug Evaluation and Research, in the briefing.

For chronic use of clopidogrel in poor metabolizers, the FDA is urging physicians to consider use of other antiplatelets, such as ticlopidine (Ticlid) or prasugrel (Effient), or potentially increasing the clopidogrel dose.

Ms. Southworth and Dr. Temple acknowledged that physicians would likely have to test patients to determine first if they were poor metabolizers, but said that there are not enough data to say that testing should be required.

Only one diagnostic for liver enzyme metabolism—the Amplichip, made by Roche—has been approved, and it is not specifically approved for CYP2C19, said Dr. Courtney Harper, director of the division of chemistry and toxicology devices at the FDA's Center for Devices and Radiologic Health. Roche cannot promote the test, since it would be an off-label use.

The Food and Drug Administration updated the labeling for clopidogrel to emphasize that new data definitively shows that the drug is less effective—and may not work at all—in patients defined as “poor metabolizers.”

The agency is notifying physicians that testing is available for the genotypes that are associated with poor metabolism, but it stopped short of recommending that all patients receive such testing before starting a course of clopidogrel (Plavix).

About 2%-14% of the population probably have those alleles and are poor metabolizers, with the rate varying by racial background, according to the FDA.

The issue of reduced metabolism was first highlighted in the clopidogrel label in May 2009. But the agency decided to add a stronger, boxed warning to clopidogrel because of the mounting evidence about poor metabolizers, including a required postmarketing study conducted by the drug's manufacturer, Sanofi-Aventis, that was submitted to the FDA, said Mary Ross Southworth, Pharm. D., a clinical analyst in the Division of Cardiovascular and Renal Products in the FDA's Center for Drug Evaluation and Research, in a briefing with reporters.

That 40-patient study confirmed that patients with the *2 and *3 alleles of the CYP2C19 liver enzyme were likely to be poor metabolizers. The *4, *5, *6, *7 and *8 alleles are associated with little to no metabolism of clopidogrel but occur less commonly than *2 and *3 alleles.

In acute situations, such as during a MI or coronary angioplasty, waiting for test results won't be reasonable, said Dr. Robert Temple, deputy director for clinical science in FDA's Center for Drug Evaluation and Research, in the briefing.

For chronic use of clopidogrel in poor metabolizers, the FDA is urging physicians to consider use of other antiplatelets, such as ticlopidine (Ticlid) or prasugrel (Effient), or potentially increasing the clopidogrel dose.

Ms. Southworth and Dr. Temple acknowledged that physicians would likely have to test patients to determine first if they were poor metabolizers, but said that there are not enough data to say that testing should be required.

Only one diagnostic for liver enzyme metabolism—the Amplichip, made by Roche—has been approved, and it is not specifically approved for CYP2C19, said Dr. Courtney Harper, director of the division of chemistry and toxicology devices at the FDA's Center for Devices and Radiologic Health. Roche cannot promote the test, since it would be an off-label use.

The Food and Drug Administration updated the labeling for clopidogrel to emphasize that new data definitively shows that the drug is less effective—and may not work at all—in patients defined as “poor metabolizers.”

The agency is notifying physicians that testing is available for the genotypes that are associated with poor metabolism, but it stopped short of recommending that all patients receive such testing before starting a course of clopidogrel (Plavix).

About 2%-14% of the population probably have those alleles and are poor metabolizers, with the rate varying by racial background, according to the FDA.

The issue of reduced metabolism was first highlighted in the clopidogrel label in May 2009. But the agency decided to add a stronger, boxed warning to clopidogrel because of the mounting evidence about poor metabolizers, including a required postmarketing study conducted by the drug's manufacturer, Sanofi-Aventis, that was submitted to the FDA, said Mary Ross Southworth, Pharm. D., a clinical analyst in the Division of Cardiovascular and Renal Products in the FDA's Center for Drug Evaluation and Research, in a briefing with reporters.

That 40-patient study confirmed that patients with the *2 and *3 alleles of the CYP2C19 liver enzyme were likely to be poor metabolizers. The *4, *5, *6, *7 and *8 alleles are associated with little to no metabolism of clopidogrel but occur less commonly than *2 and *3 alleles.

In acute situations, such as during a MI or coronary angioplasty, waiting for test results won't be reasonable, said Dr. Robert Temple, deputy director for clinical science in FDA's Center for Drug Evaluation and Research, in the briefing.

For chronic use of clopidogrel in poor metabolizers, the FDA is urging physicians to consider use of other antiplatelets, such as ticlopidine (Ticlid) or prasugrel (Effient), or potentially increasing the clopidogrel dose.

Ms. Southworth and Dr. Temple acknowledged that physicians would likely have to test patients to determine first if they were poor metabolizers, but said that there are not enough data to say that testing should be required.

Only one diagnostic for liver enzyme metabolism—the Amplichip, made by Roche—has been approved, and it is not specifically approved for CYP2C19, said Dr. Courtney Harper, director of the division of chemistry and toxicology devices at the FDA's Center for Devices and Radiologic Health. Roche cannot promote the test, since it would be an off-label use.

The Federal Trade Commission has obtained a settlement from the Indoor Tanning Association in which the industry group has agreed that it will no longer make false health and safety claims about indoor tanning.

The American Academy of Dermatology (AAD) applauded the action, noting that it had complained to the FTC in the wake of an advertising campaign launched by the Indoor Tanning Association (ITA) in March 2008. That campaign made a number of false claims, according to the FTC. Among them: that indoor tanning is approved by the government; that it is safer than outdoor tanning; and that vitamin D supplements may impair immunity.

The ITA ad campaign also claimed that the National Academy of Sciences had determined that “the risks of not getting enough ultraviolet light far outweigh the hypothetical risk of skin cancer.”

“The messages promoted by the indoor tanning industry fly in the face of scientific evidence,” said David C. Vladeck, director of the FTC's Bureau of Consumer Protection in a statement announcing the settlement.

According to the draft settlement, ITA is prohibited from “making the misrepresentations challenged in the complaint, from misrepresenting any tests or studies, and from providing deceptive advertisements to its members.” Future ads must make certain disclosures. Ads that make claims about health benefits or safety of indoor tanning have to say: “Exposure to ultraviolet radiation may increase the likelihood of developing skin cancer and can cause serious eye injury.”

The Federal Trade Commission has obtained a settlement from the Indoor Tanning Association in which the industry group has agreed that it will no longer make false health and safety claims about indoor tanning.

The American Academy of Dermatology (AAD) applauded the action, noting that it had complained to the FTC in the wake of an advertising campaign launched by the Indoor Tanning Association (ITA) in March 2008. That campaign made a number of false claims, according to the FTC. Among them: that indoor tanning is approved by the government; that it is safer than outdoor tanning; and that vitamin D supplements may impair immunity.

The ITA ad campaign also claimed that the National Academy of Sciences had determined that “the risks of not getting enough ultraviolet light far outweigh the hypothetical risk of skin cancer.”

“The messages promoted by the indoor tanning industry fly in the face of scientific evidence,” said David C. Vladeck, director of the FTC's Bureau of Consumer Protection in a statement announcing the settlement.

According to the draft settlement, ITA is prohibited from “making the misrepresentations challenged in the complaint, from misrepresenting any tests or studies, and from providing deceptive advertisements to its members.” Future ads must make certain disclosures. Ads that make claims about health benefits or safety of indoor tanning have to say: “Exposure to ultraviolet radiation may increase the likelihood of developing skin cancer and can cause serious eye injury.”

The Federal Trade Commission has obtained a settlement from the Indoor Tanning Association in which the industry group has agreed that it will no longer make false health and safety claims about indoor tanning.

The American Academy of Dermatology (AAD) applauded the action, noting that it had complained to the FTC in the wake of an advertising campaign launched by the Indoor Tanning Association (ITA) in March 2008. That campaign made a number of false claims, according to the FTC. Among them: that indoor tanning is approved by the government; that it is safer than outdoor tanning; and that vitamin D supplements may impair immunity.

The ITA ad campaign also claimed that the National Academy of Sciences had determined that “the risks of not getting enough ultraviolet light far outweigh the hypothetical risk of skin cancer.”

“The messages promoted by the indoor tanning industry fly in the face of scientific evidence,” said David C. Vladeck, director of the FTC's Bureau of Consumer Protection in a statement announcing the settlement.

According to the draft settlement, ITA is prohibited from “making the misrepresentations challenged in the complaint, from misrepresenting any tests or studies, and from providing deceptive advertisements to its members.” Future ads must make certain disclosures. Ads that make claims about health benefits or safety of indoor tanning have to say: “Exposure to ultraviolet radiation may increase the likelihood of developing skin cancer and can cause serious eye injury.”