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Inhalants Top Drug of Abuse for 12-Year-Olds
WASHINGTON — New federal data show that 12-year-olds abuse inhalants more than marijuana, cocaine, and hallucinogens combined.
From 2006 to 2008, almost 7% of 12-year-olds said they had used an inhalant to get high, according to the National Survey on Drug Use and Health, a survey sponsored by the Substance Abuse and Mental Health Services Administration (SAMHSA).
In comparison, the lifetime use rate is 5% for prescription drugs and 1.4% for marijuana. Alcohol remains the most abused substance overall among 12-year-olds.
Officials from SAMHSA, the National Institute on Drug Abuse, the National Inhalant Prevention Coalition, and the White House Office of National Drug Control Policy gathered in Washington to discuss the inhalant use data, and to urge parents and physicians to educate children and adolescents about the dangers of “huffing.”
Although federal statistics show a decline over the last decade in the numbers of people first using inhalants, the numbers are still large: 729,000 Americans tried inhalants in 2008, with 489,000 of them in the 12- to-17-year-old age group.
That's down from 821,000 total in 1998, and but up slightly from 455,000 in 1998 in the younger age group. Officials also said they are concerned that from 2007 to 2008, fewer eighth graders perceived inhalant use as harmful, according to the Monitoring the Future Survey conducted for NIDA.
Usually, a decline in risk perception is followed by an uptick in usage, officials said at the briefing.
Inhalant use is largely a phenomenon among whites, but large numbers of Hispanic and African Americans also abuse the chemicals.
The mean age for first-time inhalant use is 16—a year younger than for any other illicit substance, according to SAMHSA.
SAMHSA Administrator Pamela Hyde said inhalant use often precedes a move to other drugs. And, according to Ashley Upchurch, a 17-year-old recovering inhalant addict who spoke at the briefing, inhalants often are used to enhance the high from other drugs or alcohol.
Inhalants are easy to obtain and can often be abused without detection.
The chemicals can be found in household cleaners, paint thinner, fabric protector, magic markers, glue, hairspray, nail polish remover, and dessert topping sprays, among a multitude of other products.
Teens also inhale freon, butane, and nitrites, which are sold under names such as “Rush” or “Locker Room.”
For Ms. Upchurch, the inhalant of choice was a pressurized can used to force dust out of computer keyboards and other electronics.
The chemicals can lead to short-term memory loss, emotional instability, problems with gait and speech, and over the long term, more permanent neurologic and cardiac symptoms.
“As risky as inhalants are, many kids don't see the drugs that way,” said Dr. Timothy Condon, deputy director of NIDA. Dr. Condon said warnings about huffing dangers weren't “hype.” He added, “inhalants can be deadly.”
Dr. Jennifer N. Caudle, director of the family medicine section at Sinai Hospital, Baltimore, said there was a phenomenon called sudden sniffing death, in which the inhaler dies from cardiac arrest.
Dr. Caudle and her colleagues at the American Osteopathic Association are collaborating with the Inhalant Prevention Coalition to publicize the dangers in inhalants.
They are working together to educate physicians about the signs and symptoms of huffing, and about the need to educate adolescents regarding the dangers.
WASHINGTON — New federal data show that 12-year-olds abuse inhalants more than marijuana, cocaine, and hallucinogens combined.
From 2006 to 2008, almost 7% of 12-year-olds said they had used an inhalant to get high, according to the National Survey on Drug Use and Health, a survey sponsored by the Substance Abuse and Mental Health Services Administration (SAMHSA).
In comparison, the lifetime use rate is 5% for prescription drugs and 1.4% for marijuana. Alcohol remains the most abused substance overall among 12-year-olds.
Officials from SAMHSA, the National Institute on Drug Abuse, the National Inhalant Prevention Coalition, and the White House Office of National Drug Control Policy gathered in Washington to discuss the inhalant use data, and to urge parents and physicians to educate children and adolescents about the dangers of “huffing.”
Although federal statistics show a decline over the last decade in the numbers of people first using inhalants, the numbers are still large: 729,000 Americans tried inhalants in 2008, with 489,000 of them in the 12- to-17-year-old age group.
That's down from 821,000 total in 1998, and but up slightly from 455,000 in 1998 in the younger age group. Officials also said they are concerned that from 2007 to 2008, fewer eighth graders perceived inhalant use as harmful, according to the Monitoring the Future Survey conducted for NIDA.
Usually, a decline in risk perception is followed by an uptick in usage, officials said at the briefing.
Inhalant use is largely a phenomenon among whites, but large numbers of Hispanic and African Americans also abuse the chemicals.
The mean age for first-time inhalant use is 16—a year younger than for any other illicit substance, according to SAMHSA.
SAMHSA Administrator Pamela Hyde said inhalant use often precedes a move to other drugs. And, according to Ashley Upchurch, a 17-year-old recovering inhalant addict who spoke at the briefing, inhalants often are used to enhance the high from other drugs or alcohol.
Inhalants are easy to obtain and can often be abused without detection.
The chemicals can be found in household cleaners, paint thinner, fabric protector, magic markers, glue, hairspray, nail polish remover, and dessert topping sprays, among a multitude of other products.
Teens also inhale freon, butane, and nitrites, which are sold under names such as “Rush” or “Locker Room.”
For Ms. Upchurch, the inhalant of choice was a pressurized can used to force dust out of computer keyboards and other electronics.
The chemicals can lead to short-term memory loss, emotional instability, problems with gait and speech, and over the long term, more permanent neurologic and cardiac symptoms.
“As risky as inhalants are, many kids don't see the drugs that way,” said Dr. Timothy Condon, deputy director of NIDA. Dr. Condon said warnings about huffing dangers weren't “hype.” He added, “inhalants can be deadly.”
Dr. Jennifer N. Caudle, director of the family medicine section at Sinai Hospital, Baltimore, said there was a phenomenon called sudden sniffing death, in which the inhaler dies from cardiac arrest.
Dr. Caudle and her colleagues at the American Osteopathic Association are collaborating with the Inhalant Prevention Coalition to publicize the dangers in inhalants.
They are working together to educate physicians about the signs and symptoms of huffing, and about the need to educate adolescents regarding the dangers.
WASHINGTON — New federal data show that 12-year-olds abuse inhalants more than marijuana, cocaine, and hallucinogens combined.
From 2006 to 2008, almost 7% of 12-year-olds said they had used an inhalant to get high, according to the National Survey on Drug Use and Health, a survey sponsored by the Substance Abuse and Mental Health Services Administration (SAMHSA).
In comparison, the lifetime use rate is 5% for prescription drugs and 1.4% for marijuana. Alcohol remains the most abused substance overall among 12-year-olds.
Officials from SAMHSA, the National Institute on Drug Abuse, the National Inhalant Prevention Coalition, and the White House Office of National Drug Control Policy gathered in Washington to discuss the inhalant use data, and to urge parents and physicians to educate children and adolescents about the dangers of “huffing.”
Although federal statistics show a decline over the last decade in the numbers of people first using inhalants, the numbers are still large: 729,000 Americans tried inhalants in 2008, with 489,000 of them in the 12- to-17-year-old age group.
That's down from 821,000 total in 1998, and but up slightly from 455,000 in 1998 in the younger age group. Officials also said they are concerned that from 2007 to 2008, fewer eighth graders perceived inhalant use as harmful, according to the Monitoring the Future Survey conducted for NIDA.
Usually, a decline in risk perception is followed by an uptick in usage, officials said at the briefing.
Inhalant use is largely a phenomenon among whites, but large numbers of Hispanic and African Americans also abuse the chemicals.
The mean age for first-time inhalant use is 16—a year younger than for any other illicit substance, according to SAMHSA.
SAMHSA Administrator Pamela Hyde said inhalant use often precedes a move to other drugs. And, according to Ashley Upchurch, a 17-year-old recovering inhalant addict who spoke at the briefing, inhalants often are used to enhance the high from other drugs or alcohol.
Inhalants are easy to obtain and can often be abused without detection.
The chemicals can be found in household cleaners, paint thinner, fabric protector, magic markers, glue, hairspray, nail polish remover, and dessert topping sprays, among a multitude of other products.
Teens also inhale freon, butane, and nitrites, which are sold under names such as “Rush” or “Locker Room.”
For Ms. Upchurch, the inhalant of choice was a pressurized can used to force dust out of computer keyboards and other electronics.
The chemicals can lead to short-term memory loss, emotional instability, problems with gait and speech, and over the long term, more permanent neurologic and cardiac symptoms.
“As risky as inhalants are, many kids don't see the drugs that way,” said Dr. Timothy Condon, deputy director of NIDA. Dr. Condon said warnings about huffing dangers weren't “hype.” He added, “inhalants can be deadly.”
Dr. Jennifer N. Caudle, director of the family medicine section at Sinai Hospital, Baltimore, said there was a phenomenon called sudden sniffing death, in which the inhaler dies from cardiac arrest.
Dr. Caudle and her colleagues at the American Osteopathic Association are collaborating with the Inhalant Prevention Coalition to publicize the dangers in inhalants.
They are working together to educate physicians about the signs and symptoms of huffing, and about the need to educate adolescents regarding the dangers.
SGR Cut Delayed Again, but Only Until June 1
President Obama signed legislation 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 SGR 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.
“If the formula is not repealed, the problem will continue to grow,” he added.
President Obama signed legislation 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 SGR 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.
“If the formula is not repealed, the problem will continue to grow,” he added.
President Obama signed legislation 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 SGR 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.
“If the formula is not repealed, the problem will continue to grow,” he added.
Maintenance of Certification Data May Serve as Alternative to PQRI
A little-noticed provision of the health reform law will let physicians use data collected and reported as part of the maintenance of certification process as an alternative to the Medicare Physician Quality Reporting Initiative.
The details have yet to be worked out, but 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 (ABIM).
The advantage of the maintenance of certification (MOC) process is that physicians are familiar with it, as more than 80% of all physicians participate, she said in an interview.
Physicians have been eligible to receive bonuses for participating in the Medicare PQRI, but they have criticized it as a redundant, burdensome, and confusing process, and have complained about 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.”
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, Dr. Cassel said.
The ABIM and other specialty boards want to help CMS officials write the regulations for implementing the process, she said. “Our concept is that it would be kind of an alternative pathway [that] would include all the same conditions and measures as PQRI, but be even more comprehensive.”
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, said Dr. Michael Hagen, the 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. They 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. Last year, all participants were required to report during the full year, and about 720 family physicians participated, Dr. Hagen said in an interview.
Dr. Hagen said he doesn't expect the ABFM process to change soon, but he envisions a future in which physicians can submit data for PQRI, MOC, and meaningful electronic health records in one fell swoop.
As the three programs are currently structured, he added, “nobody wants the same information in the same way, and it's just driving people nuts.”
The process “would include all the same conditions and measures as PQRI, but be even more comprehensive,” said Dr. Christine K. Cassel, shown here at a 2009 Senate hearing.
This Month's Talk Back Question
How confident are you that maintenance of certification data can be adapted to accommodate the PQRI process?
A little-noticed provision of the health reform law will let physicians use data collected and reported as part of the maintenance of certification process as an alternative to the Medicare Physician Quality Reporting Initiative.
The details have yet to be worked out, but 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 (ABIM).
The advantage of the maintenance of certification (MOC) process is that physicians are familiar with it, as more than 80% of all physicians participate, she said in an interview.
Physicians have been eligible to receive bonuses for participating in the Medicare PQRI, but they have criticized it as a redundant, burdensome, and confusing process, and have complained about 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.”
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, Dr. Cassel said.
The ABIM and other specialty boards want to help CMS officials write the regulations for implementing the process, she said. “Our concept is that it would be kind of an alternative pathway [that] would include all the same conditions and measures as PQRI, but be even more comprehensive.”
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, said Dr. Michael Hagen, the 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. They 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. Last year, all participants were required to report during the full year, and about 720 family physicians participated, Dr. Hagen said in an interview.
Dr. Hagen said he doesn't expect the ABFM process to change soon, but he envisions a future in which physicians can submit data for PQRI, MOC, and meaningful electronic health records in one fell swoop.
As the three programs are currently structured, he added, “nobody wants the same information in the same way, and it's just driving people nuts.”
The process “would include all the same conditions and measures as PQRI, but be even more comprehensive,” said Dr. Christine K. Cassel, shown here at a 2009 Senate hearing.
This Month's Talk Back Question
How confident are you that maintenance of certification data can be adapted to accommodate the PQRI process?
A little-noticed provision of the health reform law will let physicians use data collected and reported as part of the maintenance of certification process as an alternative to the Medicare Physician Quality Reporting Initiative.
The details have yet to be worked out, but 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 (ABIM).
The advantage of the maintenance of certification (MOC) process is that physicians are familiar with it, as more than 80% of all physicians participate, she said in an interview.
Physicians have been eligible to receive bonuses for participating in the Medicare PQRI, but they have criticized it as a redundant, burdensome, and confusing process, and have complained about 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.”
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, Dr. Cassel said.
The ABIM and other specialty boards want to help CMS officials write the regulations for implementing the process, she said. “Our concept is that it would be kind of an alternative pathway [that] would include all the same conditions and measures as PQRI, but be even more comprehensive.”
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, said Dr. Michael Hagen, the 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. They 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. Last year, all participants were required to report during the full year, and about 720 family physicians participated, Dr. Hagen said in an interview.
Dr. Hagen said he doesn't expect the ABFM process to change soon, but he envisions a future in which physicians can submit data for PQRI, MOC, and meaningful electronic health records in one fell swoop.
As the three programs are currently structured, he added, “nobody wants the same information in the same way, and it's just driving people nuts.”
The process “would include all the same conditions and measures as PQRI, but be even more comprehensive,” said Dr. Christine K. Cassel, shown here at a 2009 Senate hearing.
This Month's Talk Back Question
How confident are you that maintenance of certification data can be adapted to accommodate the PQRI process?
Health Reform a Mixed Bag for Dermatologists
After more than a year of debate on the merits of health care reform, policymakers and physicians are switching gears, assessing the impact of the new law and considering how to improve it.
A strong focus on prevention and wellness is also positive, especially the new 10% tax on tanning salon owners.
"This is certainly a victory for dermatology," Dr. James told Skin & Allergy News.
The hope is that the tax will draw attention to the evidence that tanning promotes skin cancer. Perhaps it also will lead to higher costs for tanning, and thus, to discouraging individuals, especially teenagers, from indoor tanning, he said.
There are some concerns about the health reform law, however. For instance, many areas currently are experiencing a shortage of dermatologists to provide care. More patients in the system could lengthen wait times for appointments even further, Dr. James said.
Both the IPAB and the lack of a permanent fix to the Sustainable Growth Rate formula "are concerning because physicians really need a secure payment system," said Dr. James. He noted that physicians are being asked to make new investments in information technology and hire new employees to ensure that the newly insured can get access to care.
"At the same time, they're undermining our ability to do so by having a very unstable payment system," he said.
Going forward, the AAD "hopes to remain a positive influence in the regulatory framework that's going to come out of this," he said. "How these laws are going to be interpreted and how they're going to be implemented is the next big question."
Indeed, the details of the law are far from clear. The reform package was accomplished in several steps.
President Obama signed most of the health reform provisions into law March 23. Later in the week Congress passed a smaller bill--known as the reconciliation bill--that included corrections to the original package, including additional subsidies for purchasing insurance, and removed some of the more controversial political deals from the law. The President signed that companion legislation March 30.
The new law clears the way for approximately 32 million previously uninsured Americans to access health insurance in the next few years. The law creates health insurance exchanges where individuals can shop for insurance that meets minimum coverage standards. It also requires individuals to obtain health coverage and bars insurers from discriminating against people based on gender or preexisting medical conditions.
The reconciliation bill removes some of the controversial elements of the Senate-passed bill. For example, it strips out the so-called "Cornhusker kickback,"a provision that would have required the federal government to pick up the cost of expanding Medicaid coverage in Nebraska.
The reconciliation bill also includes increased federal subsidies for Americans who can't afford to buy health insurance, and it also lowers financial penalties for individuals who choose not to purchase insurance.
Of interest to physicians, the reconciliation bill increases Medicaid payments to primary care physicians, up to the level of Medicare payments in 2013 and 2014. It also increases funding for community health centers.
The law also aims to bring transparency to relationships between pharmaceutical companies and physicians and hospitals.
Under the incorporated Physician Payments Sunshine Act, sponsored by Sen. Chuck Grassley (R-Iowa) and Sen. Herb Kohl (D-Wis.), makers of medical supplies, pharmaceuticals, biologicals, and devices must report any payments or transfers of value they make to physicians and hospitals, unless it is under $100 a year, starting in 2013. Manufacturers will also have to report physician ownership stakes. The Health and Human Services department will be required to make this information available to the public.
Finally, starting in 2012, manufacturers will also have to report to HHS all the drug samples they give to physicians, if the drugs are covered by Medicare or Medicaid.
The law also provides aid to Medicare beneficiaries who fall into the Medicare part D prescription drug "doughnut hole." This year, beneficiaries who enter the doughnut hole will get a $250 rebate. Next year, drug companies will be required to provide a 50% discount on brand-name drugs paid for while the patient is in the doughnut hole, rising to 75% on both brand-name and generic drugs by 2020.
On the insurance side, the federal government will require health plans within 6 months to provide coverage for nondependent children up to age 26 years. The law also bars group health plans from excluding people on the basis of pre-existing conditions starting in 2014. For children, plans will be barred from pre-existing conditions exclusions 6 months after enactment.
During the course of final debate, no Republican member of Congress voted in favor of passing the bills. Republicans railed against the package as bloated and unaffordable at the Congressional Budget Office estimated price tag of $940 billion over 10 years, despite CBO assurance that the legislation also would reduce the deficit by $143 billion over the same period.
Republican opponents also said the legislation called for too great a role for the federal government and would interfere with the relationship between patients and their doctors.
After more than a year of debate on the merits of health care reform, policymakers and physicians are switching gears, assessing the impact of the new law and considering how to improve it.
A strong focus on prevention and wellness is also positive, especially the new 10% tax on tanning salon owners.
"This is certainly a victory for dermatology," Dr. James told Skin & Allergy News.
The hope is that the tax will draw attention to the evidence that tanning promotes skin cancer. Perhaps it also will lead to higher costs for tanning, and thus, to discouraging individuals, especially teenagers, from indoor tanning, he said.
There are some concerns about the health reform law, however. For instance, many areas currently are experiencing a shortage of dermatologists to provide care. More patients in the system could lengthen wait times for appointments even further, Dr. James said.
Both the IPAB and the lack of a permanent fix to the Sustainable Growth Rate formula "are concerning because physicians really need a secure payment system," said Dr. James. He noted that physicians are being asked to make new investments in information technology and hire new employees to ensure that the newly insured can get access to care.
"At the same time, they're undermining our ability to do so by having a very unstable payment system," he said.
Going forward, the AAD "hopes to remain a positive influence in the regulatory framework that's going to come out of this," he said. "How these laws are going to be interpreted and how they're going to be implemented is the next big question."
Indeed, the details of the law are far from clear. The reform package was accomplished in several steps.
President Obama signed most of the health reform provisions into law March 23. Later in the week Congress passed a smaller bill--known as the reconciliation bill--that included corrections to the original package, including additional subsidies for purchasing insurance, and removed some of the more controversial political deals from the law. The President signed that companion legislation March 30.
The new law clears the way for approximately 32 million previously uninsured Americans to access health insurance in the next few years. The law creates health insurance exchanges where individuals can shop for insurance that meets minimum coverage standards. It also requires individuals to obtain health coverage and bars insurers from discriminating against people based on gender or preexisting medical conditions.
The reconciliation bill removes some of the controversial elements of the Senate-passed bill. For example, it strips out the so-called "Cornhusker kickback,"a provision that would have required the federal government to pick up the cost of expanding Medicaid coverage in Nebraska.
The reconciliation bill also includes increased federal subsidies for Americans who can't afford to buy health insurance, and it also lowers financial penalties for individuals who choose not to purchase insurance.
Of interest to physicians, the reconciliation bill increases Medicaid payments to primary care physicians, up to the level of Medicare payments in 2013 and 2014. It also increases funding for community health centers.
The law also aims to bring transparency to relationships between pharmaceutical companies and physicians and hospitals.
Under the incorporated Physician Payments Sunshine Act, sponsored by Sen. Chuck Grassley (R-Iowa) and Sen. Herb Kohl (D-Wis.), makers of medical supplies, pharmaceuticals, biologicals, and devices must report any payments or transfers of value they make to physicians and hospitals, unless it is under $100 a year, starting in 2013. Manufacturers will also have to report physician ownership stakes. The Health and Human Services department will be required to make this information available to the public.
Finally, starting in 2012, manufacturers will also have to report to HHS all the drug samples they give to physicians, if the drugs are covered by Medicare or Medicaid.
The law also provides aid to Medicare beneficiaries who fall into the Medicare part D prescription drug "doughnut hole." This year, beneficiaries who enter the doughnut hole will get a $250 rebate. Next year, drug companies will be required to provide a 50% discount on brand-name drugs paid for while the patient is in the doughnut hole, rising to 75% on both brand-name and generic drugs by 2020.
On the insurance side, the federal government will require health plans within 6 months to provide coverage for nondependent children up to age 26 years. The law also bars group health plans from excluding people on the basis of pre-existing conditions starting in 2014. For children, plans will be barred from pre-existing conditions exclusions 6 months after enactment.
During the course of final debate, no Republican member of Congress voted in favor of passing the bills. Republicans railed against the package as bloated and unaffordable at the Congressional Budget Office estimated price tag of $940 billion over 10 years, despite CBO assurance that the legislation also would reduce the deficit by $143 billion over the same period.
Republican opponents also said the legislation called for too great a role for the federal government and would interfere with the relationship between patients and their doctors.
After more than a year of debate on the merits of health care reform, policymakers and physicians are switching gears, assessing the impact of the new law and considering how to improve it.
A strong focus on prevention and wellness is also positive, especially the new 10% tax on tanning salon owners.
"This is certainly a victory for dermatology," Dr. James told Skin & Allergy News.
The hope is that the tax will draw attention to the evidence that tanning promotes skin cancer. Perhaps it also will lead to higher costs for tanning, and thus, to discouraging individuals, especially teenagers, from indoor tanning, he said.
There are some concerns about the health reform law, however. For instance, many areas currently are experiencing a shortage of dermatologists to provide care. More patients in the system could lengthen wait times for appointments even further, Dr. James said.
Both the IPAB and the lack of a permanent fix to the Sustainable Growth Rate formula "are concerning because physicians really need a secure payment system," said Dr. James. He noted that physicians are being asked to make new investments in information technology and hire new employees to ensure that the newly insured can get access to care.
"At the same time, they're undermining our ability to do so by having a very unstable payment system," he said.
Going forward, the AAD "hopes to remain a positive influence in the regulatory framework that's going to come out of this," he said. "How these laws are going to be interpreted and how they're going to be implemented is the next big question."
Indeed, the details of the law are far from clear. The reform package was accomplished in several steps.
President Obama signed most of the health reform provisions into law March 23. Later in the week Congress passed a smaller bill--known as the reconciliation bill--that included corrections to the original package, including additional subsidies for purchasing insurance, and removed some of the more controversial political deals from the law. The President signed that companion legislation March 30.
The new law clears the way for approximately 32 million previously uninsured Americans to access health insurance in the next few years. The law creates health insurance exchanges where individuals can shop for insurance that meets minimum coverage standards. It also requires individuals to obtain health coverage and bars insurers from discriminating against people based on gender or preexisting medical conditions.
The reconciliation bill removes some of the controversial elements of the Senate-passed bill. For example, it strips out the so-called "Cornhusker kickback,"a provision that would have required the federal government to pick up the cost of expanding Medicaid coverage in Nebraska.
The reconciliation bill also includes increased federal subsidies for Americans who can't afford to buy health insurance, and it also lowers financial penalties for individuals who choose not to purchase insurance.
Of interest to physicians, the reconciliation bill increases Medicaid payments to primary care physicians, up to the level of Medicare payments in 2013 and 2014. It also increases funding for community health centers.
The law also aims to bring transparency to relationships between pharmaceutical companies and physicians and hospitals.
Under the incorporated Physician Payments Sunshine Act, sponsored by Sen. Chuck Grassley (R-Iowa) and Sen. Herb Kohl (D-Wis.), makers of medical supplies, pharmaceuticals, biologicals, and devices must report any payments or transfers of value they make to physicians and hospitals, unless it is under $100 a year, starting in 2013. Manufacturers will also have to report physician ownership stakes. The Health and Human Services department will be required to make this information available to the public.
Finally, starting in 2012, manufacturers will also have to report to HHS all the drug samples they give to physicians, if the drugs are covered by Medicare or Medicaid.
The law also provides aid to Medicare beneficiaries who fall into the Medicare part D prescription drug "doughnut hole." This year, beneficiaries who enter the doughnut hole will get a $250 rebate. Next year, drug companies will be required to provide a 50% discount on brand-name drugs paid for while the patient is in the doughnut hole, rising to 75% on both brand-name and generic drugs by 2020.
On the insurance side, the federal government will require health plans within 6 months to provide coverage for nondependent children up to age 26 years. The law also bars group health plans from excluding people on the basis of pre-existing conditions starting in 2014. For children, plans will be barred from pre-existing conditions exclusions 6 months after enactment.
During the course of final debate, no Republican member of Congress voted in favor of passing the bills. Republicans railed against the package as bloated and unaffordable at the Congressional Budget Office estimated price tag of $940 billion over 10 years, despite CBO assurance that the legislation also would reduce the deficit by $143 billion over the same period.
Republican opponents also said the legislation called for too great a role for the federal government and would interfere with the relationship between patients and their doctors.
Quality Guru Nominated to Head Medicare & Medicaid
The White House announced on April 19 that it has nominated Dr. Donald Berwick to lead the Centers for Medicare and Medicaid Services.
The nomination of Dr. Berwick, a pediatrician who is president and chief executive officer of the Institute for Healthcare Improvement, had been rumored for weeks.
Physicians' organizations began to express their enthusiasm for Dr. Berwick's nomination even before it was made official.
The American Medical Association praised Dr. Berwick's "visionary leadership efforts" in quality and patient safety in a statement given by Dr. Nancy H. Nielsen, the AMA's immediate-past president. "Upon confirmation, we look forward to working with Dr. Berwick at CMS on implementation of the new health reform law and on ensuring that physicians can continue to care for seniors who rely on Medicare."
With the recent passage of health reform and the continuing lack of a permanent solution for the fee cuts threatened by Medicare's sustainable growth rate formula, Dr. Berwick will have a full plate if he is confirmed by the Senate.
Physicians, hospitals, insurers, consumers, and pharmaceutical and medical device manufacturers all are hoping to influence how the law is implemented.
The medical device industry lobby, AdvaMed, issued a statement praising Dr. Berwick's "compelling vision," but reminded him also of what he will be taking on. "There is perhaps no more important job in health care," said Stephen J. Ubl, president and CEO of AdvaMed. "The decisions made by Dr. Berwick will affect the lives of America's seniors and every health care provider, and CMS will play a pivotal role in implementing the comprehensive health reform program recently enacted by Congress."
For his part, Dr. Berwick said in a statement that he felt "flattered and humbled" at his nomination. He added, "If confirmed by the U.S. Senate, I would welcome the opportunity to lead CMS because it offers the chance to help extend the effort to improve America's health care system - the very vision that led to the founding of the Institute for Healthcare Improvement."
Dr. Berwick is a member of the adjunct staff in the department of medicine at Children's Hospital, Boston, and is a consultant in pediatrics at Massachusetts General Hospital. He is an elected member of the Institute of Medicine, and previously chaired the National Advisory Council for the federal Agency for Healthcare Research and Quality. He also served on President Clinton's Advisory Commission on Consumer Protection and Quality in the Healthcare Industry in 1997 and 1998.
The White House announced on April 19 that it has nominated Dr. Donald Berwick to lead the Centers for Medicare and Medicaid Services.
The nomination of Dr. Berwick, a pediatrician who is president and chief executive officer of the Institute for Healthcare Improvement, had been rumored for weeks.
Physicians' organizations began to express their enthusiasm for Dr. Berwick's nomination even before it was made official.
The American Medical Association praised Dr. Berwick's "visionary leadership efforts" in quality and patient safety in a statement given by Dr. Nancy H. Nielsen, the AMA's immediate-past president. "Upon confirmation, we look forward to working with Dr. Berwick at CMS on implementation of the new health reform law and on ensuring that physicians can continue to care for seniors who rely on Medicare."
With the recent passage of health reform and the continuing lack of a permanent solution for the fee cuts threatened by Medicare's sustainable growth rate formula, Dr. Berwick will have a full plate if he is confirmed by the Senate.
Physicians, hospitals, insurers, consumers, and pharmaceutical and medical device manufacturers all are hoping to influence how the law is implemented.
The medical device industry lobby, AdvaMed, issued a statement praising Dr. Berwick's "compelling vision," but reminded him also of what he will be taking on. "There is perhaps no more important job in health care," said Stephen J. Ubl, president and CEO of AdvaMed. "The decisions made by Dr. Berwick will affect the lives of America's seniors and every health care provider, and CMS will play a pivotal role in implementing the comprehensive health reform program recently enacted by Congress."
For his part, Dr. Berwick said in a statement that he felt "flattered and humbled" at his nomination. He added, "If confirmed by the U.S. Senate, I would welcome the opportunity to lead CMS because it offers the chance to help extend the effort to improve America's health care system - the very vision that led to the founding of the Institute for Healthcare Improvement."
Dr. Berwick is a member of the adjunct staff in the department of medicine at Children's Hospital, Boston, and is a consultant in pediatrics at Massachusetts General Hospital. He is an elected member of the Institute of Medicine, and previously chaired the National Advisory Council for the federal Agency for Healthcare Research and Quality. He also served on President Clinton's Advisory Commission on Consumer Protection and Quality in the Healthcare Industry in 1997 and 1998.
The White House announced on April 19 that it has nominated Dr. Donald Berwick to lead the Centers for Medicare and Medicaid Services.
The nomination of Dr. Berwick, a pediatrician who is president and chief executive officer of the Institute for Healthcare Improvement, had been rumored for weeks.
Physicians' organizations began to express their enthusiasm for Dr. Berwick's nomination even before it was made official.
The American Medical Association praised Dr. Berwick's "visionary leadership efforts" in quality and patient safety in a statement given by Dr. Nancy H. Nielsen, the AMA's immediate-past president. "Upon confirmation, we look forward to working with Dr. Berwick at CMS on implementation of the new health reform law and on ensuring that physicians can continue to care for seniors who rely on Medicare."
With the recent passage of health reform and the continuing lack of a permanent solution for the fee cuts threatened by Medicare's sustainable growth rate formula, Dr. Berwick will have a full plate if he is confirmed by the Senate.
Physicians, hospitals, insurers, consumers, and pharmaceutical and medical device manufacturers all are hoping to influence how the law is implemented.
The medical device industry lobby, AdvaMed, issued a statement praising Dr. Berwick's "compelling vision," but reminded him also of what he will be taking on. "There is perhaps no more important job in health care," said Stephen J. Ubl, president and CEO of AdvaMed. "The decisions made by Dr. Berwick will affect the lives of America's seniors and every health care provider, and CMS will play a pivotal role in implementing the comprehensive health reform program recently enacted by Congress."
For his part, Dr. Berwick said in a statement that he felt "flattered and humbled" at his nomination. He added, "If confirmed by the U.S. Senate, I would welcome the opportunity to lead CMS because it offers the chance to help extend the effort to improve America's health care system - the very vision that led to the founding of the Institute for Healthcare Improvement."
Dr. Berwick is a member of the adjunct staff in the department of medicine at Children's Hospital, Boston, and is a consultant in pediatrics at Massachusetts General Hospital. He is an elected member of the Institute of Medicine, and previously chaired the National Advisory Council for the federal Agency for Healthcare Research and Quality. He also served on President Clinton's Advisory Commission on Consumer Protection and Quality in the Healthcare Industry in 1997 and 1998.
SGR Cut Delayed Until June 1
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."
MOC Process May Be Used as Alternative to PQRI
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."
IOM Calls for Overhaul of Cancer Trials Effort
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.
Benzoyl Peroxide Ruled Safe After Years of Debate
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.
FDA Sends Strong Lipodissolve Warning to Med Spas
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.