Alicia Ault

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

New ADHD Society

The American Professional Society of ADHD and Related Disorders (APSARD) made its debut in June. The Mt. Royal, N.J.-based society says it is the first devoted to ADHD and aims to improve quality of care, boost research, and disseminate best practices. The organization is also launching the quarterly peer-reviewed Journal of ADHD and Related Disorders. The board of directors includes Dr. Ronald Kessler of Harvard Medical School and Dr. Joseph Biederman, chief of the adult ADHD program at Massachusetts General Hospital. Dr. Biederman has been under fire from Sen. Chuck Grassley (R-Iowa) for alleged failures to disclose conflicts of interest. According to APSARD Executive Director Gene Terry, the society expects to fund the majority of its activities from journal subscriptions, advertising, and membership dues, and it will accept industry support for independent continuing medical education.

Parity Law Won't Have Bad Impact

The new law requiring employers to offer comparable medical and mental health coverage won't lead to a drop in benefits, according to a survey conducted for an arm of the American Psychiatric Foundation. The Partnership for Workplace Mental Health surveyed 1,000 employers on what changes they might make when the law goes into effect next January. About 40% of the 143 respondents were businesses with more than 5,000 workers; 40% had fewer than 1,000 employees. Almost 90% of respondents offered both mental health and medical coverage currently, the survey found. Only eight of the respondents said they were considering dropping mental health and substance abuse coverage, and five of those were so small that they would be exempt from the parity law, anyway.

$460 Billion for Addiction, Abuse

In what it is calling the first report of its kind, the National Center on Addiction and Substance Abuse (CASA) at Columbia University said substance abuse and addiction directly cost local, state, and federal governments close to $470 billion annually. And that was based on the 4-year-old data. The feds spent the most, $238 billion, but state governments were tapped for a hefty $135 billion. Only about 2% of overall spending went to prevention and treatment and 0.4% to research, said CASA. The largest amount of federal and state spending was for health care, $207 billion or 58% of the dollars; 13% ($47 billion) was devoted to incarceration, probation, parole, and the court systems.

Obama: Give MedPAC More Clout

The Obama administration wants to give the Medicare Payment Advisory Commission (MedPAC) greater influence. In a June 2 letter to Sen. Ted Kennedy (D-Mass.) and Sen. Max Baucus (D-Mont.), President Obama said he supported giving each MedPAC recommendation the force of law unless it's opposed by a joint resolution of Congress. This appeared to embrace the approach in the MedPAC Reform Act of 2009, which Sen. Jay Rockefeller (D-W.Va.) introduced in May. Currently, MedPAC advises Congress, which then decides whether to act on the recommendations. At a Brookings Institution conference in mid-June, White House Office of Management and Budget Director Peter Orszag said the administration wants MedPAC recommendations to “become much more relevant.”

Vermont Bans Most Pharma Gifts

Vermont Gov. Jim Douglas (R) has signed into law a bill that prohibits manufacturers of drugs, medical devices, and biologics from providing free gifts, including meals and travel, to physicians and other health care providers. The toughest of its kind in the nation, the legislation also requires disclosure of any allowed gifts or payments, regardless of their value. In 2002, a Vermont law required disclosure of gifts or payments of $25 or more. Under the stronger law, manufacturers can give physicians only gifts such as samples intended for patients, “reasonable quantities” of medical device evaluation or demonstration units, and copies of peer-reviewed articles. Companies still can provide scholarships or other support for medical students, residents, and fellows to attend educational events held by professional associations, as long as the association selects the scholarship recipient.

ED Overcrowding Continues

The emergency department wait time to see a physician for emergent patients–those who should be seen in 1-14 minutes–averaged 37 minutes in 2006. Half of such patients waited longer than recommended, the GAO said in a report. In addition, patients who should have been seen immediately waited an average of 28 minutes, and about three-fourths had to wait to be seen. Hospitals performed better with urgent cases: Those patients, who should be seen in 15-60 minutes, waited an average of 50 minutes, and only about 20% waited longer than recommended, the report said. Lack of inpatient beds continues to be the main driver of ED overcrowding, the GAO noted. The American College of Emergency Physicians warned that overcrowding and wait times will only get worse as the population ages. “People age 65 and older represent the fastest growing segment of the population and the group whose visits to the emergency department are increasing the fastest,” said Dr. Nicholas Jouriles, ACEP president, in a statement.

New ADHD Society

The American Professional Society of ADHD and Related Disorders (APSARD) made its debut in June. The Mt. Royal, N.J.-based society says it is the first devoted to ADHD and aims to improve quality of care, boost research, and disseminate best practices. The organization is also launching the quarterly peer-reviewed Journal of ADHD and Related Disorders. The board of directors includes Dr. Ronald Kessler of Harvard Medical School and Dr. Joseph Biederman, chief of the adult ADHD program at Massachusetts General Hospital. Dr. Biederman has been under fire from Sen. Chuck Grassley (R-Iowa) for alleged failures to disclose conflicts of interest. According to APSARD Executive Director Gene Terry, the society expects to fund the majority of its activities from journal subscriptions, advertising, and membership dues, and it will accept industry support for independent continuing medical education.

Parity Law Won't Have Bad Impact

The new law requiring employers to offer comparable medical and mental health coverage won't lead to a drop in benefits, according to a survey conducted for an arm of the American Psychiatric Foundation. The Partnership for Workplace Mental Health surveyed 1,000 employers on what changes they might make when the law goes into effect next January. About 40% of the 143 respondents were businesses with more than 5,000 workers; 40% had fewer than 1,000 employees. Almost 90% of respondents offered both mental health and medical coverage currently, the survey found. Only eight of the respondents said they were considering dropping mental health and substance abuse coverage, and five of those were so small that they would be exempt from the parity law, anyway.

$460 Billion for Addiction, Abuse

In what it is calling the first report of its kind, the National Center on Addiction and Substance Abuse (CASA) at Columbia University said substance abuse and addiction directly cost local, state, and federal governments close to $470 billion annually. And that was based on the 4-year-old data. The feds spent the most, $238 billion, but state governments were tapped for a hefty $135 billion. Only about 2% of overall spending went to prevention and treatment and 0.4% to research, said CASA. The largest amount of federal and state spending was for health care, $207 billion or 58% of the dollars; 13% ($47 billion) was devoted to incarceration, probation, parole, and the court systems.

Obama: Give MedPAC More Clout

The Obama administration wants to give the Medicare Payment Advisory Commission (MedPAC) greater influence. In a June 2 letter to Sen. Ted Kennedy (D-Mass.) and Sen. Max Baucus (D-Mont.), President Obama said he supported giving each MedPAC recommendation the force of law unless it's opposed by a joint resolution of Congress. This appeared to embrace the approach in the MedPAC Reform Act of 2009, which Sen. Jay Rockefeller (D-W.Va.) introduced in May. Currently, MedPAC advises Congress, which then decides whether to act on the recommendations. At a Brookings Institution conference in mid-June, White House Office of Management and Budget Director Peter Orszag said the administration wants MedPAC recommendations to “become much more relevant.”

Vermont Bans Most Pharma Gifts

Vermont Gov. Jim Douglas (R) has signed into law a bill that prohibits manufacturers of drugs, medical devices, and biologics from providing free gifts, including meals and travel, to physicians and other health care providers. The toughest of its kind in the nation, the legislation also requires disclosure of any allowed gifts or payments, regardless of their value. In 2002, a Vermont law required disclosure of gifts or payments of $25 or more. Under the stronger law, manufacturers can give physicians only gifts such as samples intended for patients, “reasonable quantities” of medical device evaluation or demonstration units, and copies of peer-reviewed articles. Companies still can provide scholarships or other support for medical students, residents, and fellows to attend educational events held by professional associations, as long as the association selects the scholarship recipient.

ED Overcrowding Continues

The emergency department wait time to see a physician for emergent patients–those who should be seen in 1-14 minutes–averaged 37 minutes in 2006. Half of such patients waited longer than recommended, the GAO said in a report. In addition, patients who should have been seen immediately waited an average of 28 minutes, and about three-fourths had to wait to be seen. Hospitals performed better with urgent cases: Those patients, who should be seen in 15-60 minutes, waited an average of 50 minutes, and only about 20% waited longer than recommended, the report said. Lack of inpatient beds continues to be the main driver of ED overcrowding, the GAO noted. The American College of Emergency Physicians warned that overcrowding and wait times will only get worse as the population ages. “People age 65 and older represent the fastest growing segment of the population and the group whose visits to the emergency department are increasing the fastest,” said Dr. Nicholas Jouriles, ACEP president, in a statement.

New ADHD Society

The American Professional Society of ADHD and Related Disorders (APSARD) made its debut in June. The Mt. Royal, N.J.-based society says it is the first devoted to ADHD and aims to improve quality of care, boost research, and disseminate best practices. The organization is also launching the quarterly peer-reviewed Journal of ADHD and Related Disorders. The board of directors includes Dr. Ronald Kessler of Harvard Medical School and Dr. Joseph Biederman, chief of the adult ADHD program at Massachusetts General Hospital. Dr. Biederman has been under fire from Sen. Chuck Grassley (R-Iowa) for alleged failures to disclose conflicts of interest. According to APSARD Executive Director Gene Terry, the society expects to fund the majority of its activities from journal subscriptions, advertising, and membership dues, and it will accept industry support for independent continuing medical education.

Parity Law Won't Have Bad Impact

The new law requiring employers to offer comparable medical and mental health coverage won't lead to a drop in benefits, according to a survey conducted for an arm of the American Psychiatric Foundation. The Partnership for Workplace Mental Health surveyed 1,000 employers on what changes they might make when the law goes into effect next January. About 40% of the 143 respondents were businesses with more than 5,000 workers; 40% had fewer than 1,000 employees. Almost 90% of respondents offered both mental health and medical coverage currently, the survey found. Only eight of the respondents said they were considering dropping mental health and substance abuse coverage, and five of those were so small that they would be exempt from the parity law, anyway.

$460 Billion for Addiction, Abuse

In what it is calling the first report of its kind, the National Center on Addiction and Substance Abuse (CASA) at Columbia University said substance abuse and addiction directly cost local, state, and federal governments close to $470 billion annually. And that was based on the 4-year-old data. The feds spent the most, $238 billion, but state governments were tapped for a hefty $135 billion. Only about 2% of overall spending went to prevention and treatment and 0.4% to research, said CASA. The largest amount of federal and state spending was for health care, $207 billion or 58% of the dollars; 13% ($47 billion) was devoted to incarceration, probation, parole, and the court systems.

Obama: Give MedPAC More Clout

The Obama administration wants to give the Medicare Payment Advisory Commission (MedPAC) greater influence. In a June 2 letter to Sen. Ted Kennedy (D-Mass.) and Sen. Max Baucus (D-Mont.), President Obama said he supported giving each MedPAC recommendation the force of law unless it's opposed by a joint resolution of Congress. This appeared to embrace the approach in the MedPAC Reform Act of 2009, which Sen. Jay Rockefeller (D-W.Va.) introduced in May. Currently, MedPAC advises Congress, which then decides whether to act on the recommendations. At a Brookings Institution conference in mid-June, White House Office of Management and Budget Director Peter Orszag said the administration wants MedPAC recommendations to “become much more relevant.”

Vermont Bans Most Pharma Gifts

Vermont Gov. Jim Douglas (R) has signed into law a bill that prohibits manufacturers of drugs, medical devices, and biologics from providing free gifts, including meals and travel, to physicians and other health care providers. The toughest of its kind in the nation, the legislation also requires disclosure of any allowed gifts or payments, regardless of their value. In 2002, a Vermont law required disclosure of gifts or payments of $25 or more. Under the stronger law, manufacturers can give physicians only gifts such as samples intended for patients, “reasonable quantities” of medical device evaluation or demonstration units, and copies of peer-reviewed articles. Companies still can provide scholarships or other support for medical students, residents, and fellows to attend educational events held by professional associations, as long as the association selects the scholarship recipient.

ED Overcrowding Continues

The emergency department wait time to see a physician for emergent patients–those who should be seen in 1-14 minutes–averaged 37 minutes in 2006. Half of such patients waited longer than recommended, the GAO said in a report. In addition, patients who should have been seen immediately waited an average of 28 minutes, and about three-fourths had to wait to be seen. Hospitals performed better with urgent cases: Those patients, who should be seen in 15-60 minutes, waited an average of 50 minutes, and only about 20% waited longer than recommended, the report said. Lack of inpatient beds continues to be the main driver of ED overcrowding, the GAO noted. The American College of Emergency Physicians warned that overcrowding and wait times will only get worse as the population ages. “People age 65 and older represent the fastest growing segment of the population and the group whose visits to the emergency department are increasing the fastest,” said Dr. Nicholas Jouriles, ACEP president, in a statement.

The Food and Drug Administration asked the manufacturer of Zicam intranasal sprays and gels that contain zinc to recall those products and advised consumers to immediately stop using them because of the potential for anosmia.

In a warning letter sent to Matrixx Initiatives, the FDA's Center for Drug Evaluation and Research said that it has directly received from consumers and health care providers more than 130 reports of anosmia associated with use of Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs, and Zicam Cold Remedy Swabs, Kids Size. In addition, the agency said in a warning letter sent to the company that it “is aware that Matrixx appears to have more than 800 reports related to loss of sense of smell associated with Zicam Cold Remedy intranasal products.”

Loss of the sense of smell has been permanent in some cases. In addition, many people who experienced anosmia said it occurred with the first dose, according to the FDA.

In a briefing with reporters, Deborah M. Autor, director of CDER's Office of Compliance, said that the agency was taking action because anosmia had the potential to be life-threatening—for instance, if someone was not able to smell a gas leak or something burning—and that it could severely affect quality of life. Also, the number of adverse event reports were very high for an over-the-counter product, Ms. Autor said. The FDA discovered the additional 800 adverse event reports during an inspection of Matrixx earlier this year, according to the agency.

“Companies have an obligation to the public to demonstrate to the FDA that their products are safe, particularly when there is evidence they may be causing serious adverse events, and they are marketed for minor, self-limiting conditions like the common cold,” Ms. Autor said.

The Zicam cold remedy products are Matrixx's top-sellers, grossing $79 million in the fiscal year that ended March 31. For the last few years, cold remedy product sales have increased about 70% annually. The original product, the Zicam Cold Remedy nasal pump, was introduced in 1999.

The cold remedy products were in somewhat of a murky regulatory area, however. They are homeopathic, containing an active ingredient—zincum gluconicum 2X—that is measured in homeopathic strength, the agency said. In its letter, the FDA acknowledged that many homeopathic products are marketed without the agency's approval.

In the case of Zicam, the products claim to shorten the duration of a cold and thus are being marketed as drugs. Therefore, Matrixx is required to seek formal approval from the agency, Ms. Autor said.

Matrixx has conducted some small safety and effectiveness studies with the zinc-containing products, but none were large enough to detect any serious side effects, she said.

A recently published meta-analysis by New Zealand researchers found that there may be some benefit from zinc-containing nasal products for adults with the common cold (J. Primary Health Care 2009;1:134-9). The authors concluded, however, that the frequency of anosmia should be established before zinc sprays or gels were widely recommended.

Matrixx has been hounded for years by reports that Zicam has led to anosmia. A Google search turns up numerous links to personal injury attorneys fishing for clients. In 2006, Matrixx settled more than 340 suits claiming that its zinc-containing products led to a loss of sense of smell. The company admitted no liability.

Dr. Charles E. Lee, a medical officer at the FDA's Division of New Drugs and Labeling Compliance, said the agency is aware of animal studies and historical reports in the medical literature linking zinc salts to anosmia.

Matrixx was required to come up with a plan to remove the Zicam products from the marketplace within 15 days of the agency's June 16 warning letter.

The Food and Drug Administration asked the manufacturer of Zicam intranasal sprays and gels that contain zinc to recall those products and advised consumers to immediately stop using them because of the potential for anosmia.

In a warning letter sent to Matrixx Initiatives, the FDA's Center for Drug Evaluation and Research said that it has directly received from consumers and health care providers more than 130 reports of anosmia associated with use of Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs, and Zicam Cold Remedy Swabs, Kids Size. In addition, the agency said in a warning letter sent to the company that it “is aware that Matrixx appears to have more than 800 reports related to loss of sense of smell associated with Zicam Cold Remedy intranasal products.”

Loss of the sense of smell has been permanent in some cases. In addition, many people who experienced anosmia said it occurred with the first dose, according to the FDA.

In a briefing with reporters, Deborah M. Autor, director of CDER's Office of Compliance, said that the agency was taking action because anosmia had the potential to be life-threatening—for instance, if someone was not able to smell a gas leak or something burning—and that it could severely affect quality of life. Also, the number of adverse event reports were very high for an over-the-counter product, Ms. Autor said. The FDA discovered the additional 800 adverse event reports during an inspection of Matrixx earlier this year, according to the agency.

“Companies have an obligation to the public to demonstrate to the FDA that their products are safe, particularly when there is evidence they may be causing serious adverse events, and they are marketed for minor, self-limiting conditions like the common cold,” Ms. Autor said.

The Zicam cold remedy products are Matrixx's top-sellers, grossing $79 million in the fiscal year that ended March 31. For the last few years, cold remedy product sales have increased about 70% annually. The original product, the Zicam Cold Remedy nasal pump, was introduced in 1999.

The cold remedy products were in somewhat of a murky regulatory area, however. They are homeopathic, containing an active ingredient—zincum gluconicum 2X—that is measured in homeopathic strength, the agency said. In its letter, the FDA acknowledged that many homeopathic products are marketed without the agency's approval.

In the case of Zicam, the products claim to shorten the duration of a cold and thus are being marketed as drugs. Therefore, Matrixx is required to seek formal approval from the agency, Ms. Autor said.

Matrixx has conducted some small safety and effectiveness studies with the zinc-containing products, but none were large enough to detect any serious side effects, she said.

A recently published meta-analysis by New Zealand researchers found that there may be some benefit from zinc-containing nasal products for adults with the common cold (J. Primary Health Care 2009;1:134-9). The authors concluded, however, that the frequency of anosmia should be established before zinc sprays or gels were widely recommended.

Matrixx has been hounded for years by reports that Zicam has led to anosmia. A Google search turns up numerous links to personal injury attorneys fishing for clients. In 2006, Matrixx settled more than 340 suits claiming that its zinc-containing products led to a loss of sense of smell. The company admitted no liability.

Dr. Charles E. Lee, a medical officer at the FDA's Division of New Drugs and Labeling Compliance, said the agency is aware of animal studies and historical reports in the medical literature linking zinc salts to anosmia.

Matrixx was required to come up with a plan to remove the Zicam products from the marketplace within 15 days of the agency's June 16 warning letter.

The Food and Drug Administration asked the manufacturer of Zicam intranasal sprays and gels that contain zinc to recall those products and advised consumers to immediately stop using them because of the potential for anosmia.

In a warning letter sent to Matrixx Initiatives, the FDA's Center for Drug Evaluation and Research said that it has directly received from consumers and health care providers more than 130 reports of anosmia associated with use of Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Nasal Swabs, and Zicam Cold Remedy Swabs, Kids Size. In addition, the agency said in a warning letter sent to the company that it “is aware that Matrixx appears to have more than 800 reports related to loss of sense of smell associated with Zicam Cold Remedy intranasal products.”

Loss of the sense of smell has been permanent in some cases. In addition, many people who experienced anosmia said it occurred with the first dose, according to the FDA.

In a briefing with reporters, Deborah M. Autor, director of CDER's Office of Compliance, said that the agency was taking action because anosmia had the potential to be life-threatening—for instance, if someone was not able to smell a gas leak or something burning—and that it could severely affect quality of life. Also, the number of adverse event reports were very high for an over-the-counter product, Ms. Autor said. The FDA discovered the additional 800 adverse event reports during an inspection of Matrixx earlier this year, according to the agency.

“Companies have an obligation to the public to demonstrate to the FDA that their products are safe, particularly when there is evidence they may be causing serious adverse events, and they are marketed for minor, self-limiting conditions like the common cold,” Ms. Autor said.

The Zicam cold remedy products are Matrixx's top-sellers, grossing $79 million in the fiscal year that ended March 31. For the last few years, cold remedy product sales have increased about 70% annually. The original product, the Zicam Cold Remedy nasal pump, was introduced in 1999.

The cold remedy products were in somewhat of a murky regulatory area, however. They are homeopathic, containing an active ingredient—zincum gluconicum 2X—that is measured in homeopathic strength, the agency said. In its letter, the FDA acknowledged that many homeopathic products are marketed without the agency's approval.

In the case of Zicam, the products claim to shorten the duration of a cold and thus are being marketed as drugs. Therefore, Matrixx is required to seek formal approval from the agency, Ms. Autor said.

Matrixx has conducted some small safety and effectiveness studies with the zinc-containing products, but none were large enough to detect any serious side effects, she said.

A recently published meta-analysis by New Zealand researchers found that there may be some benefit from zinc-containing nasal products for adults with the common cold (J. Primary Health Care 2009;1:134-9). The authors concluded, however, that the frequency of anosmia should be established before zinc sprays or gels were widely recommended.

Matrixx has been hounded for years by reports that Zicam has led to anosmia. A Google search turns up numerous links to personal injury attorneys fishing for clients. In 2006, Matrixx settled more than 340 suits claiming that its zinc-containing products led to a loss of sense of smell. The company admitted no liability.

Dr. Charles E. Lee, a medical officer at the FDA's Division of New Drugs and Labeling Compliance, said the agency is aware of animal studies and historical reports in the medical literature linking zinc salts to anosmia.

Matrixx was required to come up with a plan to remove the Zicam products from the marketplace within 15 days of the agency's June 16 warning letter.

FDA Gives Clearance to Home Laser

The Food and Drug Administration has given 510(k) clearance to Palomar Medical Technologies' home laser system for periorbital wrinkles. Palomar received FDA approval for a light-emitting, over-the-counter hair removal device in 2006. The company said the newest approval gives it entrée into "the multibillion dollar consumer skin care market." In a statement, Palomar Chief Executive Officer Joseph P. Caruso said, "The professional treatment of fine lines and wrinkles using lasers has been well established and proven to be safe and effective for years in the doctors' office using large and expensive lasers. With this breakthrough, consumers will be able to use similar technology in the privacy of their own home for a fraction of the cost." Johnson & Johnson is collaborating with Palomar.

Boasting About Botox

Nine in 10 people surveyed recently about aesthetic treatments said that they openly discuss their Botox injections and filler treatments. The survey was conducted by the Aesthetic Surgery Education & Research Foundation and supported in part by Botox maker Allergan. Survey forms were distributed to patients by physicians. From 687 analyzed responses, the typical Botox and filler patient was 40–55 years old and a working, married, mother of one to three children. Top reasons for getting Botox included patients feeling that they looked stressed or angry and that a family member or friend recommended it. Twenty-five percent said that a physician had recommended the injections. Among patients receiving fillers, 61% had gotten Juvéderm, 59% Restylane, and 13% Perlane. Nearly two-thirds of patients getting fillers said they sought to remove facial wrinkles and folds.

Evolence Gets 12-Month Okay

The dermal filler Evolence is safe and effective up to 1 year after its injection, according to the FDA in granting supplemental approval to Ortho Dermatologics. The Johnson & Johnson unit submitted data on moderate to deep facial wrinkles. Evolence is now the only collagen-based filler approved for 12-month duration, said Ortho.

Increased Vitamin D Urged

The Skin Cancer Foundation is urging adult Americans who get limited sun to increase their vitamin D intake from 400 IU daily to 1,000 IU. The vitamin D should come from both diet and supplements, said the foundation. The 1,000 IU intake is well within safety limits established by the U.S. Food and Nutrition Board, Warwick Morison, chairman of the foundation's Photobiology Committee, said in a statement. The foundation said children under 18 years old should continue to get 400 IU.

Obama: Give MedPAC More Clout

The Obama Administration wants to give the Medicare Payment Advisory Commission (MedPAC) greater influence. In a June 2 letter to Sen. Ted Kennedy (D-Mass.) and Sen. Max Baucus (D-Mont.), President Obama said he supported giving each MedPAC recommendation the force of law unless it's opposed by a joint resolution of Congress. This appeared to embrace the approach in the MedPAC Reform Act of 2009, which Sen. Jay Rockefeller (D-W.Va.) introduced in May. Currently, MedPAC advises Congress, which then decides whether to act on the recommendations. At a Brookings Institution conference in mid-June, White House Office of Management and Budget Director Peter Orszag reiterated support for giving MedPAC more teeth. Mr. Orszag said the administration wanted to "take the MedPAC recommendations and, rather than having them sit on a shelf somewhere, have them protected in a fast track procedure, voted up or down as a package, and considered within a limited period of time so they become much more relevant."

Feds Launch Disease Program

The National Institutes of Health has launched a $24 million drug development program to produce new treatments for rare and neglected diseases. The Therapeutics for Rare and Neglected Diseases program, funded by Congress this spring, creates a drug development pipeline within NIH and is intended to stimulate research collaborations with academic scientists researching these diseases, NIH said. The NIH Office of Rare Diseases Research will oversee the program. NIH estimates that more than 6,800 rare diseases affect more than 25 million Americans but that effective pharmacologic treatments exist for only about 200 of these illnesses. In addition, many neglected diseases—uncommon in the United States but more common in parts of the world where people cannot afford expensive therapies—also lack treatments, NIH said.

Funds for Rheumatic Research

The Obama administration's fiscal year 2010 budget request includes $531 million for the National Institute of Arthritis and Musculoskeletal and Skin Diseases, about $6 million more than Congress budgeted this year. The FY 2010 funds would be used to continue the agency's support for pain research related to arthritis and rheumatic diseases. NIAMS will also be part of the administration's push to accelerate cancer research by doubling NIH-wide cancer research spending by 2017. NIAMS plans to support investigator-initiated research that focuses on the effects of anticancer therapies on bone quality and muscle strength, as well as the cellular mechanisms associated with autoimmune diseases and cancer.

FDA Gives Clearance to Home Laser

The Food and Drug Administration has given 510(k) clearance to Palomar Medical Technologies' home laser system for periorbital wrinkles. Palomar received FDA approval for a light-emitting, over-the-counter hair removal device in 2006. The company said the newest approval gives it entrée into "the multibillion dollar consumer skin care market." In a statement, Palomar Chief Executive Officer Joseph P. Caruso said, "The professional treatment of fine lines and wrinkles using lasers has been well established and proven to be safe and effective for years in the doctors' office using large and expensive lasers. With this breakthrough, consumers will be able to use similar technology in the privacy of their own home for a fraction of the cost." Johnson & Johnson is collaborating with Palomar.

Boasting About Botox

Nine in 10 people surveyed recently about aesthetic treatments said that they openly discuss their Botox injections and filler treatments. The survey was conducted by the Aesthetic Surgery Education & Research Foundation and supported in part by Botox maker Allergan. Survey forms were distributed to patients by physicians. From 687 analyzed responses, the typical Botox and filler patient was 40–55 years old and a working, married, mother of one to three children. Top reasons for getting Botox included patients feeling that they looked stressed or angry and that a family member or friend recommended it. Twenty-five percent said that a physician had recommended the injections. Among patients receiving fillers, 61% had gotten Juvéderm, 59% Restylane, and 13% Perlane. Nearly two-thirds of patients getting fillers said they sought to remove facial wrinkles and folds.

Evolence Gets 12-Month Okay

The dermal filler Evolence is safe and effective up to 1 year after its injection, according to the FDA in granting supplemental approval to Ortho Dermatologics. The Johnson & Johnson unit submitted data on moderate to deep facial wrinkles. Evolence is now the only collagen-based filler approved for 12-month duration, said Ortho.

Increased Vitamin D Urged

The Skin Cancer Foundation is urging adult Americans who get limited sun to increase their vitamin D intake from 400 IU daily to 1,000 IU. The vitamin D should come from both diet and supplements, said the foundation. The 1,000 IU intake is well within safety limits established by the U.S. Food and Nutrition Board, Warwick Morison, chairman of the foundation's Photobiology Committee, said in a statement. The foundation said children under 18 years old should continue to get 400 IU.

Obama: Give MedPAC More Clout

The Obama Administration wants to give the Medicare Payment Advisory Commission (MedPAC) greater influence. In a June 2 letter to Sen. Ted Kennedy (D-Mass.) and Sen. Max Baucus (D-Mont.), President Obama said he supported giving each MedPAC recommendation the force of law unless it's opposed by a joint resolution of Congress. This appeared to embrace the approach in the MedPAC Reform Act of 2009, which Sen. Jay Rockefeller (D-W.Va.) introduced in May. Currently, MedPAC advises Congress, which then decides whether to act on the recommendations. At a Brookings Institution conference in mid-June, White House Office of Management and Budget Director Peter Orszag reiterated support for giving MedPAC more teeth. Mr. Orszag said the administration wanted to "take the MedPAC recommendations and, rather than having them sit on a shelf somewhere, have them protected in a fast track procedure, voted up or down as a package, and considered within a limited period of time so they become much more relevant."

Feds Launch Disease Program

The National Institutes of Health has launched a $24 million drug development program to produce new treatments for rare and neglected diseases. The Therapeutics for Rare and Neglected Diseases program, funded by Congress this spring, creates a drug development pipeline within NIH and is intended to stimulate research collaborations with academic scientists researching these diseases, NIH said. The NIH Office of Rare Diseases Research will oversee the program. NIH estimates that more than 6,800 rare diseases affect more than 25 million Americans but that effective pharmacologic treatments exist for only about 200 of these illnesses. In addition, many neglected diseases—uncommon in the United States but more common in parts of the world where people cannot afford expensive therapies—also lack treatments, NIH said.

Funds for Rheumatic Research

The Obama administration's fiscal year 2010 budget request includes $531 million for the National Institute of Arthritis and Musculoskeletal and Skin Diseases, about $6 million more than Congress budgeted this year. The FY 2010 funds would be used to continue the agency's support for pain research related to arthritis and rheumatic diseases. NIAMS will also be part of the administration's push to accelerate cancer research by doubling NIH-wide cancer research spending by 2017. NIAMS plans to support investigator-initiated research that focuses on the effects of anticancer therapies on bone quality and muscle strength, as well as the cellular mechanisms associated with autoimmune diseases and cancer.

FDA Gives Clearance to Home Laser

The Food and Drug Administration has given 510(k) clearance to Palomar Medical Technologies' home laser system for periorbital wrinkles. Palomar received FDA approval for a light-emitting, over-the-counter hair removal device in 2006. The company said the newest approval gives it entrée into "the multibillion dollar consumer skin care market." In a statement, Palomar Chief Executive Officer Joseph P. Caruso said, "The professional treatment of fine lines and wrinkles using lasers has been well established and proven to be safe and effective for years in the doctors' office using large and expensive lasers. With this breakthrough, consumers will be able to use similar technology in the privacy of their own home for a fraction of the cost." Johnson & Johnson is collaborating with Palomar.

Boasting About Botox

Nine in 10 people surveyed recently about aesthetic treatments said that they openly discuss their Botox injections and filler treatments. The survey was conducted by the Aesthetic Surgery Education & Research Foundation and supported in part by Botox maker Allergan. Survey forms were distributed to patients by physicians. From 687 analyzed responses, the typical Botox and filler patient was 40–55 years old and a working, married, mother of one to three children. Top reasons for getting Botox included patients feeling that they looked stressed or angry and that a family member or friend recommended it. Twenty-five percent said that a physician had recommended the injections. Among patients receiving fillers, 61% had gotten Juvéderm, 59% Restylane, and 13% Perlane. Nearly two-thirds of patients getting fillers said they sought to remove facial wrinkles and folds.

Evolence Gets 12-Month Okay

The dermal filler Evolence is safe and effective up to 1 year after its injection, according to the FDA in granting supplemental approval to Ortho Dermatologics. The Johnson & Johnson unit submitted data on moderate to deep facial wrinkles. Evolence is now the only collagen-based filler approved for 12-month duration, said Ortho.

Increased Vitamin D Urged

The Skin Cancer Foundation is urging adult Americans who get limited sun to increase their vitamin D intake from 400 IU daily to 1,000 IU. The vitamin D should come from both diet and supplements, said the foundation. The 1,000 IU intake is well within safety limits established by the U.S. Food and Nutrition Board, Warwick Morison, chairman of the foundation's Photobiology Committee, said in a statement. The foundation said children under 18 years old should continue to get 400 IU.

Obama: Give MedPAC More Clout

The Obama Administration wants to give the Medicare Payment Advisory Commission (MedPAC) greater influence. In a June 2 letter to Sen. Ted Kennedy (D-Mass.) and Sen. Max Baucus (D-Mont.), President Obama said he supported giving each MedPAC recommendation the force of law unless it's opposed by a joint resolution of Congress. This appeared to embrace the approach in the MedPAC Reform Act of 2009, which Sen. Jay Rockefeller (D-W.Va.) introduced in May. Currently, MedPAC advises Congress, which then decides whether to act on the recommendations. At a Brookings Institution conference in mid-June, White House Office of Management and Budget Director Peter Orszag reiterated support for giving MedPAC more teeth. Mr. Orszag said the administration wanted to "take the MedPAC recommendations and, rather than having them sit on a shelf somewhere, have them protected in a fast track procedure, voted up or down as a package, and considered within a limited period of time so they become much more relevant."

Feds Launch Disease Program

The National Institutes of Health has launched a $24 million drug development program to produce new treatments for rare and neglected diseases. The Therapeutics for Rare and Neglected Diseases program, funded by Congress this spring, creates a drug development pipeline within NIH and is intended to stimulate research collaborations with academic scientists researching these diseases, NIH said. The NIH Office of Rare Diseases Research will oversee the program. NIH estimates that more than 6,800 rare diseases affect more than 25 million Americans but that effective pharmacologic treatments exist for only about 200 of these illnesses. In addition, many neglected diseases—uncommon in the United States but more common in parts of the world where people cannot afford expensive therapies—also lack treatments, NIH said.

Funds for Rheumatic Research

The Obama administration's fiscal year 2010 budget request includes $531 million for the National Institute of Arthritis and Musculoskeletal and Skin Diseases, about $6 million more than Congress budgeted this year. The FY 2010 funds would be used to continue the agency's support for pain research related to arthritis and rheumatic diseases. NIAMS will also be part of the administration's push to accelerate cancer research by doubling NIH-wide cancer research spending by 2017. NIAMS plans to support investigator-initiated research that focuses on the effects of anticancer therapies on bone quality and muscle strength, as well as the cellular mechanisms associated with autoimmune diseases and cancer.

AUSTIN, TEX. — A new microfoam in trials in the United States holds promise for sclerotherapy, said Dr. Girish Munavalli, who also discussed other techniques currently available for addressing varicose veins.

It is important to address these veins, as they are indicative of venous insufficiency and saphenous reflux, Dr. Munavalli of Charlotte, N.C., said at the annual meeting of the American College of Mohs Surgery.

Some 60% of the U.S. population has varicose veins, and the frequency increases with age. Approximately 6 million workdays are lost annually because of complications from varicose veins, which can include venous leg ulcers, he said. Current treatment options include surgery (ligation and stripping); endovenous heat ablation; sclerotherapy; and a newer device, called ClosureFAST (VNUS Medical Technologies), which ablates the veins with a radiofrequency catheter. He said that he tends not to use lasers for sclerotherapy.

Dr. Munavalli is currently investigating the new microfoam, which is being used in Europe. It "is a really interesting technique. Hopefully, we'll get [Food and Drug Administration] approval soon," he said.

The product is contained in a can that holds air, but with less nitrogen than room air. When the sclerosant is pumped through the can, it creates much smaller bubbles, which increases the surface area of contact. The microfoam is thicker, compared with a sclerosant that's mixed with room air, said Dr. Munavalli. It still should be administered with ultrasound guidance.

In addition to being an investigator for the microfoam, Dr. Munavalli disclosed that he is on the speakers bureau and is a consultant for DUSA Pharmaceuticals.

AUSTIN, TEX. — A new microfoam in trials in the United States holds promise for sclerotherapy, said Dr. Girish Munavalli, who also discussed other techniques currently available for addressing varicose veins.

It is important to address these veins, as they are indicative of venous insufficiency and saphenous reflux, Dr. Munavalli of Charlotte, N.C., said at the annual meeting of the American College of Mohs Surgery.

Some 60% of the U.S. population has varicose veins, and the frequency increases with age. Approximately 6 million workdays are lost annually because of complications from varicose veins, which can include venous leg ulcers, he said. Current treatment options include surgery (ligation and stripping); endovenous heat ablation; sclerotherapy; and a newer device, called ClosureFAST (VNUS Medical Technologies), which ablates the veins with a radiofrequency catheter. He said that he tends not to use lasers for sclerotherapy.

Dr. Munavalli is currently investigating the new microfoam, which is being used in Europe. It "is a really interesting technique. Hopefully, we'll get [Food and Drug Administration] approval soon," he said.

The product is contained in a can that holds air, but with less nitrogen than room air. When the sclerosant is pumped through the can, it creates much smaller bubbles, which increases the surface area of contact. The microfoam is thicker, compared with a sclerosant that's mixed with room air, said Dr. Munavalli. It still should be administered with ultrasound guidance.

In addition to being an investigator for the microfoam, Dr. Munavalli disclosed that he is on the speakers bureau and is a consultant for DUSA Pharmaceuticals.

AUSTIN, TEX. — A new microfoam in trials in the United States holds promise for sclerotherapy, said Dr. Girish Munavalli, who also discussed other techniques currently available for addressing varicose veins.

It is important to address these veins, as they are indicative of venous insufficiency and saphenous reflux, Dr. Munavalli of Charlotte, N.C., said at the annual meeting of the American College of Mohs Surgery.

Some 60% of the U.S. population has varicose veins, and the frequency increases with age. Approximately 6 million workdays are lost annually because of complications from varicose veins, which can include venous leg ulcers, he said. Current treatment options include surgery (ligation and stripping); endovenous heat ablation; sclerotherapy; and a newer device, called ClosureFAST (VNUS Medical Technologies), which ablates the veins with a radiofrequency catheter. He said that he tends not to use lasers for sclerotherapy.

Dr. Munavalli is currently investigating the new microfoam, which is being used in Europe. It "is a really interesting technique. Hopefully, we'll get [Food and Drug Administration] approval soon," he said.

The product is contained in a can that holds air, but with less nitrogen than room air. When the sclerosant is pumped through the can, it creates much smaller bubbles, which increases the surface area of contact. The microfoam is thicker, compared with a sclerosant that's mixed with room air, said Dr. Munavalli. It still should be administered with ultrasound guidance.

In addition to being an investigator for the microfoam, Dr. Munavalli disclosed that he is on the speakers bureau and is a consultant for DUSA Pharmaceuticals.

AUSTIN, TEX. — A chart review aimed at quantifying the incidence and type of periocular skin cancers showed that the vast majority were basal cell carcinomas, and that there was a slight predominance of the cancers in men.

The study was undertaken partly because there has been an increase in eyelid malignancies, which is thought to be due to a lack of protection from ultraviolet radiation, Dr. Jens Thiele said at the annual meeting of the American College of Mohs Surgery.

This is the largest U.S.-based study of periocular cancers ever conducted, said Dr. Thiele, a dermatologist in private practice in Birmingham, Ala.

He and his colleagues reviewed charts at a single center from 553 consecutive Mohs surgery patients from January 2005 to September 2008.

All of the patients were white (Fitzpatrick skin types I, II, and III). There were 346 men and 207 women. Interestingly, 61% of the tumors were in men.

Of the tumors, there were 435 basal cell carcinomas (BCCs), 105 squamous cell carcinomas (SCCs), 10 melanomas, and one of each of the following: sebaceous carcinoma, trichoepithelioma, and dermatofibrosarcoma protuberans.

The investigators also quantified location and pre- and postoperative defect sizes. Most often, BCCs were located on the lower eyelid (246, or 57%). They were also found on the medial canthus (28%), upper eyelid (10%), and lateral canthus (6%).

Squamous cell tumors also were found most frequently on the lower eyelid (64 or 61%), followed by the medial canthus (17%), the upper eyelid (15%), and the lateral canthus (7%), Dr. Thiele reported.

Six of the 10 melanomas were also on the lower eyelid; 8 of the tumors were in females.

For BCCs, the pre- and postoperative sizes were smallest on the upper eyelids, while the largest tumors were found on the medial canthus. The mean number of Mohs layers needed for BCC clearance ranged from 1.33 in the lateral canthus to 1.42 in the medial canthus.

SCCs had larger pre-op and postop sizes, but the number of layers needed for clearance was lower. The mean number for SCC clearance was 1.5 in the medial canthus and 1.1 in the lateral canthus, Dr. Thiele said.

Although this study confirmed the results of some large Australian databases, the chart review found a two fold higher occurrence of SCCs on the upper eyelid than had been reported previously, he noted.

Better knowledge of high-risk histologies and locations of periocular skin cancers should assist surgeons, said Dr. Thiele, who reported no conflicts.

AUSTIN, TEX. — A chart review aimed at quantifying the incidence and type of periocular skin cancers showed that the vast majority were basal cell carcinomas, and that there was a slight predominance of the cancers in men.

The study was undertaken partly because there has been an increase in eyelid malignancies, which is thought to be due to a lack of protection from ultraviolet radiation, Dr. Jens Thiele said at the annual meeting of the American College of Mohs Surgery.

This is the largest U.S.-based study of periocular cancers ever conducted, said Dr. Thiele, a dermatologist in private practice in Birmingham, Ala.

He and his colleagues reviewed charts at a single center from 553 consecutive Mohs surgery patients from January 2005 to September 2008.

All of the patients were white (Fitzpatrick skin types I, II, and III). There were 346 men and 207 women. Interestingly, 61% of the tumors were in men.

Of the tumors, there were 435 basal cell carcinomas (BCCs), 105 squamous cell carcinomas (SCCs), 10 melanomas, and one of each of the following: sebaceous carcinoma, trichoepithelioma, and dermatofibrosarcoma protuberans.

The investigators also quantified location and pre- and postoperative defect sizes. Most often, BCCs were located on the lower eyelid (246, or 57%). They were also found on the medial canthus (28%), upper eyelid (10%), and lateral canthus (6%).

Squamous cell tumors also were found most frequently on the lower eyelid (64 or 61%), followed by the medial canthus (17%), the upper eyelid (15%), and the lateral canthus (7%), Dr. Thiele reported.

Six of the 10 melanomas were also on the lower eyelid; 8 of the tumors were in females.

For BCCs, the pre- and postoperative sizes were smallest on the upper eyelids, while the largest tumors were found on the medial canthus. The mean number of Mohs layers needed for BCC clearance ranged from 1.33 in the lateral canthus to 1.42 in the medial canthus.

SCCs had larger pre-op and postop sizes, but the number of layers needed for clearance was lower. The mean number for SCC clearance was 1.5 in the medial canthus and 1.1 in the lateral canthus, Dr. Thiele said.

Although this study confirmed the results of some large Australian databases, the chart review found a two fold higher occurrence of SCCs on the upper eyelid than had been reported previously, he noted.

Better knowledge of high-risk histologies and locations of periocular skin cancers should assist surgeons, said Dr. Thiele, who reported no conflicts.

AUSTIN, TEX. — A chart review aimed at quantifying the incidence and type of periocular skin cancers showed that the vast majority were basal cell carcinomas, and that there was a slight predominance of the cancers in men.

The study was undertaken partly because there has been an increase in eyelid malignancies, which is thought to be due to a lack of protection from ultraviolet radiation, Dr. Jens Thiele said at the annual meeting of the American College of Mohs Surgery.

This is the largest U.S.-based study of periocular cancers ever conducted, said Dr. Thiele, a dermatologist in private practice in Birmingham, Ala.

He and his colleagues reviewed charts at a single center from 553 consecutive Mohs surgery patients from January 2005 to September 2008.

All of the patients were white (Fitzpatrick skin types I, II, and III). There were 346 men and 207 women. Interestingly, 61% of the tumors were in men.

Of the tumors, there were 435 basal cell carcinomas (BCCs), 105 squamous cell carcinomas (SCCs), 10 melanomas, and one of each of the following: sebaceous carcinoma, trichoepithelioma, and dermatofibrosarcoma protuberans.

The investigators also quantified location and pre- and postoperative defect sizes. Most often, BCCs were located on the lower eyelid (246, or 57%). They were also found on the medial canthus (28%), upper eyelid (10%), and lateral canthus (6%).

Squamous cell tumors also were found most frequently on the lower eyelid (64 or 61%), followed by the medial canthus (17%), the upper eyelid (15%), and the lateral canthus (7%), Dr. Thiele reported.

Six of the 10 melanomas were also on the lower eyelid; 8 of the tumors were in females.

For BCCs, the pre- and postoperative sizes were smallest on the upper eyelids, while the largest tumors were found on the medial canthus. The mean number of Mohs layers needed for BCC clearance ranged from 1.33 in the lateral canthus to 1.42 in the medial canthus.

SCCs had larger pre-op and postop sizes, but the number of layers needed for clearance was lower. The mean number for SCC clearance was 1.5 in the medial canthus and 1.1 in the lateral canthus, Dr. Thiele said.

Although this study confirmed the results of some large Australian databases, the chart review found a two fold higher occurrence of SCCs on the upper eyelid than had been reported previously, he noted.

Better knowledge of high-risk histologies and locations of periocular skin cancers should assist surgeons, said Dr. Thiele, who reported no conflicts.

AUSTIN, TEX. — Mohs surgery seems to be effective for primary sebaceous cell carcinoma when there is an absence of orbital extension, according to a retrospective case study.

Sebaceous cell carcinoma of the eyelid is extremely rare, but not uncommon, representing up to 5% of all eyelid tumors, Dr. Humza Ilyas of the University of Wisconsin, Madison, said at the annual meeting of the American College of Mohs Surgery. Dr. Ilyas presented a series of 16 cases that were seen at a single clinic from 1987 to 2008.

A major issue with these tumors is that they are frequently misdiagnosed histopathologically and clinically, said Dr. Ilyas. That causes a delay in diagnosis, so "it's important to maintain a high index of suspicion," he said. Patients who have the tumors typically do not do that well. Primary sebaceous cell carcinoma is complicated by recurrence, and it can be multicentric or demonstrate pagetoid spread.

In this case series, nine tumors (56%) were on the upper lid and seven (44%) were on the lower lid. The patients' mean age was 72 years, with a range of 51–90. Mean time from symptom onset to diagnosis was 8 months (range, 5 weeks to 2 years).

One patient had orbital extension, and exenteration was performed. All other patients had Mohs surgery (15), with a mean of 3.5 layers. One Mohs patient was lost to follow-up. Post-op follow-up ranged from 7 months to 14 years, with a mean duration of 4.5 years.

One (7%) of the 14 Mohs patients developed a local recurrence 1.5 years after surgery; that patient had exenteration as treatment and had no further evidence of disease 12 years later. Twelve of the 14 (86%) had no evidence of local recurrence.

Of the 14 who had Mohs, 6 (43%) had histologic evidence of pagetoid spread. There were no deaths attributable to the sebaceous cell carcinoma.

Dr. Ilyas said that although this was a small study, Mohs appears to be the most effective option for tumors with pagetoid spread. The outcomes were comparable to published series in the literature with conventional wide excision with frozen or paraffin margin controls, he said. There may be instances where adjunctive radiation or topical chemotherapy may be helpful.

Dr. Ilyas reported no disclosures.

AUSTIN, TEX. — Mohs surgery seems to be effective for primary sebaceous cell carcinoma when there is an absence of orbital extension, according to a retrospective case study.

Sebaceous cell carcinoma of the eyelid is extremely rare, but not uncommon, representing up to 5% of all eyelid tumors, Dr. Humza Ilyas of the University of Wisconsin, Madison, said at the annual meeting of the American College of Mohs Surgery. Dr. Ilyas presented a series of 16 cases that were seen at a single clinic from 1987 to 2008.

A major issue with these tumors is that they are frequently misdiagnosed histopathologically and clinically, said Dr. Ilyas. That causes a delay in diagnosis, so "it's important to maintain a high index of suspicion," he said. Patients who have the tumors typically do not do that well. Primary sebaceous cell carcinoma is complicated by recurrence, and it can be multicentric or demonstrate pagetoid spread.

In this case series, nine tumors (56%) were on the upper lid and seven (44%) were on the lower lid. The patients' mean age was 72 years, with a range of 51–90. Mean time from symptom onset to diagnosis was 8 months (range, 5 weeks to 2 years).

One patient had orbital extension, and exenteration was performed. All other patients had Mohs surgery (15), with a mean of 3.5 layers. One Mohs patient was lost to follow-up. Post-op follow-up ranged from 7 months to 14 years, with a mean duration of 4.5 years.

One (7%) of the 14 Mohs patients developed a local recurrence 1.5 years after surgery; that patient had exenteration as treatment and had no further evidence of disease 12 years later. Twelve of the 14 (86%) had no evidence of local recurrence.

Of the 14 who had Mohs, 6 (43%) had histologic evidence of pagetoid spread. There were no deaths attributable to the sebaceous cell carcinoma.

Dr. Ilyas said that although this was a small study, Mohs appears to be the most effective option for tumors with pagetoid spread. The outcomes were comparable to published series in the literature with conventional wide excision with frozen or paraffin margin controls, he said. There may be instances where adjunctive radiation or topical chemotherapy may be helpful.

Dr. Ilyas reported no disclosures.

AUSTIN, TEX. — Mohs surgery seems to be effective for primary sebaceous cell carcinoma when there is an absence of orbital extension, according to a retrospective case study.

Sebaceous cell carcinoma of the eyelid is extremely rare, but not uncommon, representing up to 5% of all eyelid tumors, Dr. Humza Ilyas of the University of Wisconsin, Madison, said at the annual meeting of the American College of Mohs Surgery. Dr. Ilyas presented a series of 16 cases that were seen at a single clinic from 1987 to 2008.

A major issue with these tumors is that they are frequently misdiagnosed histopathologically and clinically, said Dr. Ilyas. That causes a delay in diagnosis, so "it's important to maintain a high index of suspicion," he said. Patients who have the tumors typically do not do that well. Primary sebaceous cell carcinoma is complicated by recurrence, and it can be multicentric or demonstrate pagetoid spread.

In this case series, nine tumors (56%) were on the upper lid and seven (44%) were on the lower lid. The patients' mean age was 72 years, with a range of 51–90. Mean time from symptom onset to diagnosis was 8 months (range, 5 weeks to 2 years).

One patient had orbital extension, and exenteration was performed. All other patients had Mohs surgery (15), with a mean of 3.5 layers. One Mohs patient was lost to follow-up. Post-op follow-up ranged from 7 months to 14 years, with a mean duration of 4.5 years.

One (7%) of the 14 Mohs patients developed a local recurrence 1.5 years after surgery; that patient had exenteration as treatment and had no further evidence of disease 12 years later. Twelve of the 14 (86%) had no evidence of local recurrence.

Of the 14 who had Mohs, 6 (43%) had histologic evidence of pagetoid spread. There were no deaths attributable to the sebaceous cell carcinoma.

Dr. Ilyas said that although this was a small study, Mohs appears to be the most effective option for tumors with pagetoid spread. The outcomes were comparable to published series in the literature with conventional wide excision with frozen or paraffin margin controls, he said. There may be instances where adjunctive radiation or topical chemotherapy may be helpful.

Dr. Ilyas reported no disclosures.

AUSTIN, TEX. — A chart review aimed at quantifying the incidence and type of periocular skin cancers showed that the vast majority were basal cell carcinomas, and that there was a slight predominance of the cancers in men.

The study was undertaken because there has been an increase in eyelid malignancies that is thought to be due to a lack of protection from ultraviolet radiation, Dr. Jens Thiele said at the annual meeting of the American College of Mohs Surgery.

This is the largest U.S.-based study of periocular cancers ever conducted, said Dr. Thiele, a dermatologist in private practice in Birmingham, Ala. He and his colleagues reviewed charts at a single center from 553 consecutive Mohs surgery patients from January 2005 to September 2008.

All of the patients were white (Fitzpatrick skin types I, II, and III). There were 346 men and 207 women. Interestingly, 61% of the tumors were in men.

Of the tumors, there were 435 basal cell carcinomas (BCCs), 105 squamous cell carcinomas (SCCs), 10 melanomas, and one of each of the following: sebaceous carcinoma, trichoepithelioma, and dermatofibrosarcoma protuberans.

The investigators also quantified location and pre- and postoperative defect sizes. Most often, BCCs were located on the lower eyelid (246, or 57%). They were also found on the medial canthus (28%), upper eyelid (10%), and lateral canthus (6%).

The squamous cell tumors also were found most frequently on the lower eyelid (64 or 61%), followed by the medial canthus (17%), the upper eyelid (15%), and the lateral canthus (7%). Six of the 10 melanomas were also on the lower eyelid; 8 of the tumors were in females.

For BCCs, the pre- and postoperative sizes were smallest on the upper eyelids, while the largest tumors were found on the medial canthus. The mean number of Mohs layers needed for BCC clearance ranged from 1.33 in the lateral canthus to 1.42 in the medial canthus.

SCCs had larger pre-op and postop sizes, but the number of layers needed for clearance was lower. The mean number for SCC clearance was 1.5 in the medial canthus and 1.1 in the lateral canthus, Dr. Thiele said.

Dr. Thiele reported no conflicts.

AUSTIN, TEX. — A chart review aimed at quantifying the incidence and type of periocular skin cancers showed that the vast majority were basal cell carcinomas, and that there was a slight predominance of the cancers in men.

The study was undertaken because there has been an increase in eyelid malignancies that is thought to be due to a lack of protection from ultraviolet radiation, Dr. Jens Thiele said at the annual meeting of the American College of Mohs Surgery.

This is the largest U.S.-based study of periocular cancers ever conducted, said Dr. Thiele, a dermatologist in private practice in Birmingham, Ala. He and his colleagues reviewed charts at a single center from 553 consecutive Mohs surgery patients from January 2005 to September 2008.

All of the patients were white (Fitzpatrick skin types I, II, and III). There were 346 men and 207 women. Interestingly, 61% of the tumors were in men.

Of the tumors, there were 435 basal cell carcinomas (BCCs), 105 squamous cell carcinomas (SCCs), 10 melanomas, and one of each of the following: sebaceous carcinoma, trichoepithelioma, and dermatofibrosarcoma protuberans.

The investigators also quantified location and pre- and postoperative defect sizes. Most often, BCCs were located on the lower eyelid (246, or 57%). They were also found on the medial canthus (28%), upper eyelid (10%), and lateral canthus (6%).

The squamous cell tumors also were found most frequently on the lower eyelid (64 or 61%), followed by the medial canthus (17%), the upper eyelid (15%), and the lateral canthus (7%). Six of the 10 melanomas were also on the lower eyelid; 8 of the tumors were in females.

For BCCs, the pre- and postoperative sizes were smallest on the upper eyelids, while the largest tumors were found on the medial canthus. The mean number of Mohs layers needed for BCC clearance ranged from 1.33 in the lateral canthus to 1.42 in the medial canthus.

SCCs had larger pre-op and postop sizes, but the number of layers needed for clearance was lower. The mean number for SCC clearance was 1.5 in the medial canthus and 1.1 in the lateral canthus, Dr. Thiele said.

Dr. Thiele reported no conflicts.

AUSTIN, TEX. — A chart review aimed at quantifying the incidence and type of periocular skin cancers showed that the vast majority were basal cell carcinomas, and that there was a slight predominance of the cancers in men.

The study was undertaken because there has been an increase in eyelid malignancies that is thought to be due to a lack of protection from ultraviolet radiation, Dr. Jens Thiele said at the annual meeting of the American College of Mohs Surgery.

This is the largest U.S.-based study of periocular cancers ever conducted, said Dr. Thiele, a dermatologist in private practice in Birmingham, Ala. He and his colleagues reviewed charts at a single center from 553 consecutive Mohs surgery patients from January 2005 to September 2008.

All of the patients were white (Fitzpatrick skin types I, II, and III). There were 346 men and 207 women. Interestingly, 61% of the tumors were in men.

Of the tumors, there were 435 basal cell carcinomas (BCCs), 105 squamous cell carcinomas (SCCs), 10 melanomas, and one of each of the following: sebaceous carcinoma, trichoepithelioma, and dermatofibrosarcoma protuberans.

The investigators also quantified location and pre- and postoperative defect sizes. Most often, BCCs were located on the lower eyelid (246, or 57%). They were also found on the medial canthus (28%), upper eyelid (10%), and lateral canthus (6%).

The squamous cell tumors also were found most frequently on the lower eyelid (64 or 61%), followed by the medial canthus (17%), the upper eyelid (15%), and the lateral canthus (7%). Six of the 10 melanomas were also on the lower eyelid; 8 of the tumors were in females.

For BCCs, the pre- and postoperative sizes were smallest on the upper eyelids, while the largest tumors were found on the medial canthus. The mean number of Mohs layers needed for BCC clearance ranged from 1.33 in the lateral canthus to 1.42 in the medial canthus.

SCCs had larger pre-op and postop sizes, but the number of layers needed for clearance was lower. The mean number for SCC clearance was 1.5 in the medial canthus and 1.1 in the lateral canthus, Dr. Thiele said.

Dr. Thiele reported no conflicts.

There is not enough evidence to support coverage of pharmacogenomic testing that predicts a patient's response to warfarin, the Centers for Medicare and Medicaid Services said.

The testing can be covered if it is part of a prospective, randomized trial that meets certain criteria proposed by the agency, the CMS said. The study should determine whether the test can predict the frequency and severity of hemorrhage, thromboembolism related to the primary indication for anticoagulation, other thromboembolic events, and mortality, the agency noted. And any trial should determine whether the results are generalizable to the Medicare population.

There are a number of lab tests already approved by the FDA, and many labs offer so-called “home-brew” tests. Although there is evidence that these tests accurately identify people with certain gene variants that may heighten their responsiveness to warfarin, there is no direct evidence of any improvement in health as a result, the agency said.

In February, a Medicare Evidence Development and Coverage Advisory Committee determined that there were not enough data to support national coverage of the testing.

The CMS said trials may show genetic testing to be of benefit. “The ability to more effectively treat or prevent blood thrombosis and avoid the risk of hemorrhage due to overanticoagulation by guiding warfarin dosing based on genetic testing results would be a worthwhile potential benefit for the numerous Medicare beneficiaries, perhaps exceeding 1 million annually, who are initiating anticoagulant therapy,” the agency noted.

There is not enough evidence to support coverage of pharmacogenomic testing that predicts a patient's response to warfarin, the Centers for Medicare and Medicaid Services said.

The testing can be covered if it is part of a prospective, randomized trial that meets certain criteria proposed by the agency, the CMS said. The study should determine whether the test can predict the frequency and severity of hemorrhage, thromboembolism related to the primary indication for anticoagulation, other thromboembolic events, and mortality, the agency noted. And any trial should determine whether the results are generalizable to the Medicare population.

There are a number of lab tests already approved by the FDA, and many labs offer so-called “home-brew” tests. Although there is evidence that these tests accurately identify people with certain gene variants that may heighten their responsiveness to warfarin, there is no direct evidence of any improvement in health as a result, the agency said.

In February, a Medicare Evidence Development and Coverage Advisory Committee determined that there were not enough data to support national coverage of the testing.

The CMS said trials may show genetic testing to be of benefit. “The ability to more effectively treat or prevent blood thrombosis and avoid the risk of hemorrhage due to overanticoagulation by guiding warfarin dosing based on genetic testing results would be a worthwhile potential benefit for the numerous Medicare beneficiaries, perhaps exceeding 1 million annually, who are initiating anticoagulant therapy,” the agency noted.

There is not enough evidence to support coverage of pharmacogenomic testing that predicts a patient's response to warfarin, the Centers for Medicare and Medicaid Services said.

The testing can be covered if it is part of a prospective, randomized trial that meets certain criteria proposed by the agency, the CMS said. The study should determine whether the test can predict the frequency and severity of hemorrhage, thromboembolism related to the primary indication for anticoagulation, other thromboembolic events, and mortality, the agency noted. And any trial should determine whether the results are generalizable to the Medicare population.

There are a number of lab tests already approved by the FDA, and many labs offer so-called “home-brew” tests. Although there is evidence that these tests accurately identify people with certain gene variants that may heighten their responsiveness to warfarin, there is no direct evidence of any improvement in health as a result, the agency said.

In February, a Medicare Evidence Development and Coverage Advisory Committee determined that there were not enough data to support national coverage of the testing.

The CMS said trials may show genetic testing to be of benefit. “The ability to more effectively treat or prevent blood thrombosis and avoid the risk of hemorrhage due to overanticoagulation by guiding warfarin dosing based on genetic testing results would be a worthwhile potential benefit for the numerous Medicare beneficiaries, perhaps exceeding 1 million annually, who are initiating anticoagulant therapy,” the agency noted.

WASHINGTON — The three committees with jurisdiction over health care in the House of Representatives will make their health reform “framework” public early this month, Rep. Henry Waxman (D-Calif.) said at a forum sponsored by the policy analysis firm Avalere Health.

Rep. Waxman, chairman of the House Energy and Commerce Committee, said that his staff, along with the staffs of both the Ways and Means and the Education and Labor committees, have been working together to create a “proposal that will allow all three to start from a common point.”

Once the framework has been developed, House Republicans will be brought into the process, Rep. Waxman said. After the plan has been released publicly, the three committees will hold hearings to get “viewpoints from stakeholders,” he added.

Then the committees will work with the Rules Committee and the House leadership to bring the bill to the House floor. Rep. Waxman predicted passage of a reform bill by the end of July in the House and by the end of the year for both the House and the Senate.

Rep. Waxman was less certain regarding the substance of the legislation. “It must solve the problems of coverage, cost, and quality together,” he said.

The bill will build on what's now in place, including Medicare, Medicaid, and private insurance, he said. But he left no doubt where he stood on having a government-supported “public plan” as an option for those who could not buy insurance in the private market.

“This system will work better if there is a public health insurance plan available as an alternative to private health insurance,” Rep. Waxman said, with opportunity for private insurers to compete.

Rep. Waxman said that he was confident that health reform will succeed in 2009, noting that President Barack Obama has given it a high priority, and that House and Senate leaders, as well as almost all other players in the debate, are unified in achieving that goal.

Not surprisingly, Rep. Waxman said that he sees action by the Energy and Commerce Committee as a significant predictor of how health reform will fare in the Congress overall. Noting that the panel has 59 members, the chairman said that the panel makes up 15% of the House and numerically represents 60% of the Senate. The committee balances urban and rural areas, and conservative and liberal ideologies, he said. “If we can find consensus in the Energy and Commerce Committee,” he said, “we'll be pretty close to what we need in the House and Senate.”

WASHINGTON — The three committees with jurisdiction over health care in the House of Representatives will make their health reform “framework” public early this month, Rep. Henry Waxman (D-Calif.) said at a forum sponsored by the policy analysis firm Avalere Health.

Rep. Waxman, chairman of the House Energy and Commerce Committee, said that his staff, along with the staffs of both the Ways and Means and the Education and Labor committees, have been working together to create a “proposal that will allow all three to start from a common point.”

Once the framework has been developed, House Republicans will be brought into the process, Rep. Waxman said. After the plan has been released publicly, the three committees will hold hearings to get “viewpoints from stakeholders,” he added.

Then the committees will work with the Rules Committee and the House leadership to bring the bill to the House floor. Rep. Waxman predicted passage of a reform bill by the end of July in the House and by the end of the year for both the House and the Senate.

Rep. Waxman was less certain regarding the substance of the legislation. “It must solve the problems of coverage, cost, and quality together,” he said.

The bill will build on what's now in place, including Medicare, Medicaid, and private insurance, he said. But he left no doubt where he stood on having a government-supported “public plan” as an option for those who could not buy insurance in the private market.

“This system will work better if there is a public health insurance plan available as an alternative to private health insurance,” Rep. Waxman said, with opportunity for private insurers to compete.

Rep. Waxman said that he was confident that health reform will succeed in 2009, noting that President Barack Obama has given it a high priority, and that House and Senate leaders, as well as almost all other players in the debate, are unified in achieving that goal.

Not surprisingly, Rep. Waxman said that he sees action by the Energy and Commerce Committee as a significant predictor of how health reform will fare in the Congress overall. Noting that the panel has 59 members, the chairman said that the panel makes up 15% of the House and numerically represents 60% of the Senate. The committee balances urban and rural areas, and conservative and liberal ideologies, he said. “If we can find consensus in the Energy and Commerce Committee,” he said, “we'll be pretty close to what we need in the House and Senate.”

WASHINGTON — The three committees with jurisdiction over health care in the House of Representatives will make their health reform “framework” public early this month, Rep. Henry Waxman (D-Calif.) said at a forum sponsored by the policy analysis firm Avalere Health.

Rep. Waxman, chairman of the House Energy and Commerce Committee, said that his staff, along with the staffs of both the Ways and Means and the Education and Labor committees, have been working together to create a “proposal that will allow all three to start from a common point.”

Once the framework has been developed, House Republicans will be brought into the process, Rep. Waxman said. After the plan has been released publicly, the three committees will hold hearings to get “viewpoints from stakeholders,” he added.

Then the committees will work with the Rules Committee and the House leadership to bring the bill to the House floor. Rep. Waxman predicted passage of a reform bill by the end of July in the House and by the end of the year for both the House and the Senate.

Rep. Waxman was less certain regarding the substance of the legislation. “It must solve the problems of coverage, cost, and quality together,” he said.

The bill will build on what's now in place, including Medicare, Medicaid, and private insurance, he said. But he left no doubt where he stood on having a government-supported “public plan” as an option for those who could not buy insurance in the private market.

“This system will work better if there is a public health insurance plan available as an alternative to private health insurance,” Rep. Waxman said, with opportunity for private insurers to compete.

Rep. Waxman said that he was confident that health reform will succeed in 2009, noting that President Barack Obama has given it a high priority, and that House and Senate leaders, as well as almost all other players in the debate, are unified in achieving that goal.

Not surprisingly, Rep. Waxman said that he sees action by the Energy and Commerce Committee as a significant predictor of how health reform will fare in the Congress overall. Noting that the panel has 59 members, the chairman said that the panel makes up 15% of the House and numerically represents 60% of the Senate. The committee balances urban and rural areas, and conservative and liberal ideologies, he said. “If we can find consensus in the Energy and Commerce Committee,” he said, “we'll be pretty close to what we need in the House and Senate.”