Alicia Ault

In an assessment of performance by one of the nation's largest physician revenue management companies, Humana and Medicare were rated highest when it came to paying quickly and being easy to work with.

The data were tabulated and made public by AthenaHealth, a company in Watertown, Mass., that manages $2 billion in revenues for 7,000 physicians, nurses, and other health care providers in 33 states.

In explaining why the company decided to make the data available—free of charge—Jeremy Delinsky, director of process innovation at AthenaHealth, said, “We found the story was too compelling to sit on.” And, physicians who know more about their insurers will have more leverage in contracting and a better opportunity to improve their bottom line, he said.

The company assessed 5 million “charge lines” worth of claims data from the fourth quarter of 2005. To be a part of the ranking, national payers had to have at least 10,000 “charge lines,” or line items, and regional payers at least 3,000.

Insurers were ranked according to an overall index that gave the most weight to financial performance. That performance included the number of days in accounts receivable, the percentage of claims paid and closed on the first pass, and the percentage of charges transferred to the patient. The index also included an administrative measure encompassing the claims denial rate, the percentage requiring a phone call to clarify a response from the insurer, and the percentage of claims lost. Finally, a small amount of weight was given to the difficulty of working within the payer's rules.

Nationally, Humana ranked number one, followed by Medicare, United Health Group, Aetna, Cigna, Champus, and Wellpoint. According to AthenaHealth, Aetna denies claims twice as often as Humana, and the reasons are so unclear that 17% of claims need follow-up calls. Wellpoint tended to take the longest to pay and was the most aggressive in shifting responsibility to physicians to get payments from patients.

For all payers, claims stay in accounts receivable for an average of 38 days.

There was considerable variation in performance at the regional level. In the northeast, for example, BlueCross BlueShield of Pennsylvania/Independence BlueCross was the top-ranked plan, followed by Tufts Health Plan. In the west, PacifiCare was first, followed by Medicare B in Texas and United Health Group. The largest regional payers mostly provided clear reasons for denials, rarely shifted the responsibility to physicians to secure payment, and paid most claims on first submission and within 30 days.

Regional payers seemed to be more efficient and perhaps even more powerful than the national insurers, said Mr. Delinsky. National payers have been growing in size, but “it's unclear whether consolidation has resulted in the scale they hoped for.”

AthenaHealth did not assess payers' relative reimbursement rates because it would not be legal to publicize those rates, Mr. Delinsky said. However, he suggested that physicians could use his company's rankings to negotiate for a higher fee if the payer is hard to work with, or potentially accept a lower payment rate if the insurer pays more quickly and imposes less of an administrative burden.

The insurance industry did not respond directly to the rankings, but America's Health Insurance Plans, a national trade association, recently completed a study showing that 98% of claims submitted electronically are processed within a month of receipt. The study, based on aggregated data from 25 million claims processed by a sample of 26 health insurers, found that 75% of claims are submitted electronically, up from 24% in 1995.

If there is a delay in payment, it's often because the claim has not been received in a timely manner from the physician's office, according to AHIP.

Go to www.athenapayerview.com

In an assessment of performance by one of the nation's largest physician revenue management companies, Humana and Medicare were rated highest when it came to paying quickly and being easy to work with.

The data were tabulated and made public by AthenaHealth, a company in Watertown, Mass., that manages $2 billion in revenues for 7,000 physicians, nurses, and other health care providers in 33 states.

In explaining why the company decided to make the data available—free of charge—Jeremy Delinsky, director of process innovation at AthenaHealth, said, “We found the story was too compelling to sit on.” And, physicians who know more about their insurers will have more leverage in contracting and a better opportunity to improve their bottom line, he said.

The company assessed 5 million “charge lines” worth of claims data from the fourth quarter of 2005. To be a part of the ranking, national payers had to have at least 10,000 “charge lines,” or line items, and regional payers at least 3,000.

Insurers were ranked according to an overall index that gave the most weight to financial performance. That performance included the number of days in accounts receivable, the percentage of claims paid and closed on the first pass, and the percentage of charges transferred to the patient. The index also included an administrative measure encompassing the claims denial rate, the percentage requiring a phone call to clarify a response from the insurer, and the percentage of claims lost. Finally, a small amount of weight was given to the difficulty of working within the payer's rules.

Nationally, Humana ranked number one, followed by Medicare, United Health Group, Aetna, Cigna, Champus, and Wellpoint. According to AthenaHealth, Aetna denies claims twice as often as Humana, and the reasons are so unclear that 17% of claims need follow-up calls. Wellpoint tended to take the longest to pay and was the most aggressive in shifting responsibility to physicians to get payments from patients.

For all payers, claims stay in accounts receivable for an average of 38 days.

There was considerable variation in performance at the regional level. In the northeast, for example, BlueCross BlueShield of Pennsylvania/Independence BlueCross was the top-ranked plan, followed by Tufts Health Plan. In the west, PacifiCare was first, followed by Medicare B in Texas and United Health Group. The largest regional payers mostly provided clear reasons for denials, rarely shifted the responsibility to physicians to secure payment, and paid most claims on first submission and within 30 days.

Regional payers seemed to be more efficient and perhaps even more powerful than the national insurers, said Mr. Delinsky. National payers have been growing in size, but “it's unclear whether consolidation has resulted in the scale they hoped for.”

AthenaHealth did not assess payers' relative reimbursement rates because it would not be legal to publicize those rates, Mr. Delinsky said. However, he suggested that physicians could use his company's rankings to negotiate for a higher fee if the payer is hard to work with, or potentially accept a lower payment rate if the insurer pays more quickly and imposes less of an administrative burden.

The insurance industry did not respond directly to the rankings, but America's Health Insurance Plans, a national trade association, recently completed a study showing that 98% of claims submitted electronically are processed within a month of receipt. The study, based on aggregated data from 25 million claims processed by a sample of 26 health insurers, found that 75% of claims are submitted electronically, up from 24% in 1995.

If there is a delay in payment, it's often because the claim has not been received in a timely manner from the physician's office, according to AHIP.

Go to www.athenapayerview.com

In an assessment of performance by one of the nation's largest physician revenue management companies, Humana and Medicare were rated highest when it came to paying quickly and being easy to work with.

The data were tabulated and made public by AthenaHealth, a company in Watertown, Mass., that manages $2 billion in revenues for 7,000 physicians, nurses, and other health care providers in 33 states.

In explaining why the company decided to make the data available—free of charge—Jeremy Delinsky, director of process innovation at AthenaHealth, said, “We found the story was too compelling to sit on.” And, physicians who know more about their insurers will have more leverage in contracting and a better opportunity to improve their bottom line, he said.

The company assessed 5 million “charge lines” worth of claims data from the fourth quarter of 2005. To be a part of the ranking, national payers had to have at least 10,000 “charge lines,” or line items, and regional payers at least 3,000.

Insurers were ranked according to an overall index that gave the most weight to financial performance. That performance included the number of days in accounts receivable, the percentage of claims paid and closed on the first pass, and the percentage of charges transferred to the patient. The index also included an administrative measure encompassing the claims denial rate, the percentage requiring a phone call to clarify a response from the insurer, and the percentage of claims lost. Finally, a small amount of weight was given to the difficulty of working within the payer's rules.

Nationally, Humana ranked number one, followed by Medicare, United Health Group, Aetna, Cigna, Champus, and Wellpoint. According to AthenaHealth, Aetna denies claims twice as often as Humana, and the reasons are so unclear that 17% of claims need follow-up calls. Wellpoint tended to take the longest to pay and was the most aggressive in shifting responsibility to physicians to get payments from patients.

For all payers, claims stay in accounts receivable for an average of 38 days.

There was considerable variation in performance at the regional level. In the northeast, for example, BlueCross BlueShield of Pennsylvania/Independence BlueCross was the top-ranked plan, followed by Tufts Health Plan. In the west, PacifiCare was first, followed by Medicare B in Texas and United Health Group. The largest regional payers mostly provided clear reasons for denials, rarely shifted the responsibility to physicians to secure payment, and paid most claims on first submission and within 30 days.

Regional payers seemed to be more efficient and perhaps even more powerful than the national insurers, said Mr. Delinsky. National payers have been growing in size, but “it's unclear whether consolidation has resulted in the scale they hoped for.”

AthenaHealth did not assess payers' relative reimbursement rates because it would not be legal to publicize those rates, Mr. Delinsky said. However, he suggested that physicians could use his company's rankings to negotiate for a higher fee if the payer is hard to work with, or potentially accept a lower payment rate if the insurer pays more quickly and imposes less of an administrative burden.

The insurance industry did not respond directly to the rankings, but America's Health Insurance Plans, a national trade association, recently completed a study showing that 98% of claims submitted electronically are processed within a month of receipt. The study, based on aggregated data from 25 million claims processed by a sample of 26 health insurers, found that 75% of claims are submitted electronically, up from 24% in 1995.

If there is a delay in payment, it's often because the claim has not been received in a timely manner from the physician's office, according to AHIP.

Go to www.athenapayerview.com

In an assessment of performance by one of the nation's largest physician revenue management companies, Humana and Medicare were rated highest when it came to paying quickly and being easy to work with.

The performance data were tabulated and made public by AthenaHealth, a Watertown, Mass.-based company that manages $2 billion in revenues for 7,000 physicians, nurses, and other health care providers in 33 states.

In explaining why the company decided to make the data available free of charge, Jeremy Delinsky, director of process innovation at AthenaHealth, said, “We were a little skittish about making it public, but we found the story was too compelling to sit on.” And, physicians who know more about their insurers will have more leverage in contracting and a better opportunity to improve their bottom line, he said.

The company assessed 5 million “charge lines” worth of claims data from the fourth quarter of 2005. To be a part of the ranking, national payers had to have at least 10,000 “charge lines,” or line items, and regional payers at least 3,000.

Insurers were ranked according to an overall index that gave the most weight to financial performance. That performance included days in accounts receivable, percentage of claims paid and closed on the first pass, and percentage of charges transferred to the patient.

In addition to financial performance, the index included an administrative measure encompassing the claims denial rate, the percentage requiring a phone call to clarify a response from the insurer, and the percentage of claims lost. Finally, a small amount of weight was given to the difficulty of working within the payer's rules.

Nationally, Humana ranked number one, followed by Medicare, United Health Group, Aetna, Cigna, Champus, and Wellpoint. According to AthenaHealth, Aetna denies claims twice as often as Humana, and the reasons are so unclear that 17% of claims need follow-up calls. Wellpoint tended to take the longest to pay, and more than any other payer, the company aggressively shifts responsibility to physicians to get payment from the patient.

For all payers, claims stay in accounts receivable for an average of 38 days.

On the regional level, there was a wide variation in performance.

In the northeast, for example, BlueCross BlueShield of Pennsylvania/Independence BlueCross was the top-ranked plan, followed by Tufts Health Plan and Fallon Health Plan. In the west, PacifiCare was first, followed by Medicare B in Texas and United Health Group. The largest regional payers mostly provided clear reasons for denials, rarely shifted the responsibility to physicians to secure payment, and paid most claims upon first submission and within 30 days.

Regional payers appeared to be more efficient and perhaps even more powerful than the national insurers, said Mr. Delinsky. National payers have been growing in size, but “it's unclear to us whether consolidation has resulted in the scale they hoped for,” he said.

AthenaHealth did not assess payers' relative reimbursement rates because it would not be legal to publicize those rates, Mr. Delinsky said. However, he suggested that physicians could use his company's rankings to negotiate for a higher fee if the payer is hard to work with, or potentially accept a lower payment rate if the insurer pays more quickly and imposes less of an administrative burden.

The insurance industry did not respond directly to the rankings, but America's Health Insurance Plans, a national trade association, completed a study recently showing that 98% of claims submitted electronically are processed within a month of receipt. The study, based on aggregated data from 25 million claims processed by a sample of 26 health insurers, found that 75% of all claims are submitted electronically, up from 24% in 1995.

If there is a delay in payment, it's often because the claim has not been received in a timely manner from the physician's office, according to AHIP. The group said that 3 in 10 claims were received more than 30 days after the date of service. Paper claims are more likely to get held up. A third of paper claims took 60 days or more to reach the payer, said AHIP.

The rankings are posted at www.athenapayerview.com

In an assessment of performance by one of the nation's largest physician revenue management companies, Humana and Medicare were rated highest when it came to paying quickly and being easy to work with.

The performance data were tabulated and made public by AthenaHealth, a Watertown, Mass.-based company that manages $2 billion in revenues for 7,000 physicians, nurses, and other health care providers in 33 states.

In explaining why the company decided to make the data available free of charge, Jeremy Delinsky, director of process innovation at AthenaHealth, said, “We were a little skittish about making it public, but we found the story was too compelling to sit on.” And, physicians who know more about their insurers will have more leverage in contracting and a better opportunity to improve their bottom line, he said.

The company assessed 5 million “charge lines” worth of claims data from the fourth quarter of 2005. To be a part of the ranking, national payers had to have at least 10,000 “charge lines,” or line items, and regional payers at least 3,000.

Insurers were ranked according to an overall index that gave the most weight to financial performance. That performance included days in accounts receivable, percentage of claims paid and closed on the first pass, and percentage of charges transferred to the patient.

In addition to financial performance, the index included an administrative measure encompassing the claims denial rate, the percentage requiring a phone call to clarify a response from the insurer, and the percentage of claims lost. Finally, a small amount of weight was given to the difficulty of working within the payer's rules.

Nationally, Humana ranked number one, followed by Medicare, United Health Group, Aetna, Cigna, Champus, and Wellpoint. According to AthenaHealth, Aetna denies claims twice as often as Humana, and the reasons are so unclear that 17% of claims need follow-up calls. Wellpoint tended to take the longest to pay, and more than any other payer, the company aggressively shifts responsibility to physicians to get payment from the patient.

For all payers, claims stay in accounts receivable for an average of 38 days.

On the regional level, there was a wide variation in performance.

In the northeast, for example, BlueCross BlueShield of Pennsylvania/Independence BlueCross was the top-ranked plan, followed by Tufts Health Plan and Fallon Health Plan. In the west, PacifiCare was first, followed by Medicare B in Texas and United Health Group. The largest regional payers mostly provided clear reasons for denials, rarely shifted the responsibility to physicians to secure payment, and paid most claims upon first submission and within 30 days.

Regional payers appeared to be more efficient and perhaps even more powerful than the national insurers, said Mr. Delinsky. National payers have been growing in size, but “it's unclear to us whether consolidation has resulted in the scale they hoped for,” he said.

AthenaHealth did not assess payers' relative reimbursement rates because it would not be legal to publicize those rates, Mr. Delinsky said. However, he suggested that physicians could use his company's rankings to negotiate for a higher fee if the payer is hard to work with, or potentially accept a lower payment rate if the insurer pays more quickly and imposes less of an administrative burden.

The insurance industry did not respond directly to the rankings, but America's Health Insurance Plans, a national trade association, completed a study recently showing that 98% of claims submitted electronically are processed within a month of receipt. The study, based on aggregated data from 25 million claims processed by a sample of 26 health insurers, found that 75% of all claims are submitted electronically, up from 24% in 1995.

If there is a delay in payment, it's often because the claim has not been received in a timely manner from the physician's office, according to AHIP. The group said that 3 in 10 claims were received more than 30 days after the date of service. Paper claims are more likely to get held up. A third of paper claims took 60 days or more to reach the payer, said AHIP.

The rankings are posted at www.athenapayerview.com

In an assessment of performance by one of the nation's largest physician revenue management companies, Humana and Medicare were rated highest when it came to paying quickly and being easy to work with.

The performance data were tabulated and made public by AthenaHealth, a Watertown, Mass.-based company that manages $2 billion in revenues for 7,000 physicians, nurses, and other health care providers in 33 states.

In explaining why the company decided to make the data available free of charge, Jeremy Delinsky, director of process innovation at AthenaHealth, said, “We were a little skittish about making it public, but we found the story was too compelling to sit on.” And, physicians who know more about their insurers will have more leverage in contracting and a better opportunity to improve their bottom line, he said.

The company assessed 5 million “charge lines” worth of claims data from the fourth quarter of 2005. To be a part of the ranking, national payers had to have at least 10,000 “charge lines,” or line items, and regional payers at least 3,000.

Insurers were ranked according to an overall index that gave the most weight to financial performance. That performance included days in accounts receivable, percentage of claims paid and closed on the first pass, and percentage of charges transferred to the patient.

In addition to financial performance, the index included an administrative measure encompassing the claims denial rate, the percentage requiring a phone call to clarify a response from the insurer, and the percentage of claims lost. Finally, a small amount of weight was given to the difficulty of working within the payer's rules.

Nationally, Humana ranked number one, followed by Medicare, United Health Group, Aetna, Cigna, Champus, and Wellpoint. According to AthenaHealth, Aetna denies claims twice as often as Humana, and the reasons are so unclear that 17% of claims need follow-up calls. Wellpoint tended to take the longest to pay, and more than any other payer, the company aggressively shifts responsibility to physicians to get payment from the patient.

For all payers, claims stay in accounts receivable for an average of 38 days.

On the regional level, there was a wide variation in performance.

In the northeast, for example, BlueCross BlueShield of Pennsylvania/Independence BlueCross was the top-ranked plan, followed by Tufts Health Plan and Fallon Health Plan. In the west, PacifiCare was first, followed by Medicare B in Texas and United Health Group. The largest regional payers mostly provided clear reasons for denials, rarely shifted the responsibility to physicians to secure payment, and paid most claims upon first submission and within 30 days.

Regional payers appeared to be more efficient and perhaps even more powerful than the national insurers, said Mr. Delinsky. National payers have been growing in size, but “it's unclear to us whether consolidation has resulted in the scale they hoped for,” he said.

AthenaHealth did not assess payers' relative reimbursement rates because it would not be legal to publicize those rates, Mr. Delinsky said. However, he suggested that physicians could use his company's rankings to negotiate for a higher fee if the payer is hard to work with, or potentially accept a lower payment rate if the insurer pays more quickly and imposes less of an administrative burden.

The insurance industry did not respond directly to the rankings, but America's Health Insurance Plans, a national trade association, completed a study recently showing that 98% of claims submitted electronically are processed within a month of receipt. The study, based on aggregated data from 25 million claims processed by a sample of 26 health insurers, found that 75% of all claims are submitted electronically, up from 24% in 1995.

If there is a delay in payment, it's often because the claim has not been received in a timely manner from the physician's office, according to AHIP. The group said that 3 in 10 claims were received more than 30 days after the date of service. Paper claims are more likely to get held up. A third of paper claims took 60 days or more to reach the payer, said AHIP.

The rankings are posted at www.athenapayerview.com

BETHESDA, MD. – Tobacco cessation programs that employ telephone quit lines and counseling and nicotine replacement therapy are highly effective, and they should be offered to more smokers and users of smokeless tobacco, according to a panel of physicians, other health care providers, and community advocates at a conference on the prevention, cessation, and control of tobacco use sponsored by the National Institutes of Health.

The 14-member panel was charged with issuing a consensus statement on the state of the science after sifting through the available evidence and listening to several days of presentations from the public. The NIH committee found ample evidence that tobacco-related illnesses are a huge burden in the United States–leading to 440,000 deaths each year–and also that there are many successful strategies for preventing use or helping people quit. But there are huge and numerous barriers blocking tobacco users from taking advantage of prevention and cessation programs, the committee added.

Of the 44.5 million adult smokers in the United States, 77% would like to quit, and 40% make an attempt in any given year, according to the panel. But only 5% succeed, mostly because those attempting to quit cannot access effective treatments.

“To increase demand for treatments, we must motivate smokers to want them, expect them, and use them,” said Dr. David F. Ransohoff of the University of North Carolina at Chapel Hill, and chairman of the NIH panel, in a statement.

One of the biggest challenges is stopping people from starting. The data show that most smokers begin in adolescence. Effective strategies to keep children from picking up the habit include raising taxes to increase cigarette prices, passing–and then enforcing–laws to prohibit minors' access to tobacco, and creating smoke-free zones, said the panel. Restricting tobacco ads and promotion and disseminating antitobacco mass media campaigns also work, the committee said.

“Tobacco is a legal product, but it's illegal to sell that product to youth, so simply enforcing the law of not selling tobacco products to youth would help a great deal,” said panelist Stephen B. Thomas, Ph.D., director of the Center for Minority Health at the University of Pittsburgh.

The committee also found that reimbursement for smoking cessation counseling or nicotine replacement products increased physician intervention and encouraged more patients to make use of the services. Patients also are more apt to seek out and use the services when discussions of smoking and quitting are made a routine part of every primary care visit or before every hospital discharge, the panel said.

There was some concern among antitobacco activists that the panel might endorse an idea making the rounds–that people trying to quit smoking could reduce the level of harm by switching to smokeless tobacco. But the committee found limited evidence to support this notion and reiterated in their statement, “Use of any tobacco product must be discouraged.”

The committee also stated that people with psychiatric conditions–especially schizophrenia and major depressive disorder–are more likely to be smokers and to have a harder time quitting, with more severe withdrawal symptoms.

Going forward, patients and providers should be made more aware of the benefits of cessation and the resources for quitting, and reimbursement policies should be established, said the panel.

One antitobacco organization, the Campaign for Tobacco-Free Kids, said it was pleased with the panel's deliberations and statement. “For the most part, they hit all the major issues and, in our opinion, got most of it right,” said Matt Barry, director of policy research for the Washington-based campaign.

Copies of the consensus statement can be found at http://consensus.nih.gov

BETHESDA, MD. – Tobacco cessation programs that employ telephone quit lines and counseling and nicotine replacement therapy are highly effective, and they should be offered to more smokers and users of smokeless tobacco, according to a panel of physicians, other health care providers, and community advocates at a conference on the prevention, cessation, and control of tobacco use sponsored by the National Institutes of Health.

The 14-member panel was charged with issuing a consensus statement on the state of the science after sifting through the available evidence and listening to several days of presentations from the public. The NIH committee found ample evidence that tobacco-related illnesses are a huge burden in the United States–leading to 440,000 deaths each year–and also that there are many successful strategies for preventing use or helping people quit. But there are huge and numerous barriers blocking tobacco users from taking advantage of prevention and cessation programs, the committee added.

Of the 44.5 million adult smokers in the United States, 77% would like to quit, and 40% make an attempt in any given year, according to the panel. But only 5% succeed, mostly because those attempting to quit cannot access effective treatments.

“To increase demand for treatments, we must motivate smokers to want them, expect them, and use them,” said Dr. David F. Ransohoff of the University of North Carolina at Chapel Hill, and chairman of the NIH panel, in a statement.

One of the biggest challenges is stopping people from starting. The data show that most smokers begin in adolescence. Effective strategies to keep children from picking up the habit include raising taxes to increase cigarette prices, passing–and then enforcing–laws to prohibit minors' access to tobacco, and creating smoke-free zones, said the panel. Restricting tobacco ads and promotion and disseminating antitobacco mass media campaigns also work, the committee said.

“Tobacco is a legal product, but it's illegal to sell that product to youth, so simply enforcing the law of not selling tobacco products to youth would help a great deal,” said panelist Stephen B. Thomas, Ph.D., director of the Center for Minority Health at the University of Pittsburgh.

The committee also found that reimbursement for smoking cessation counseling or nicotine replacement products increased physician intervention and encouraged more patients to make use of the services. Patients also are more apt to seek out and use the services when discussions of smoking and quitting are made a routine part of every primary care visit or before every hospital discharge, the panel said.

There was some concern among antitobacco activists that the panel might endorse an idea making the rounds–that people trying to quit smoking could reduce the level of harm by switching to smokeless tobacco. But the committee found limited evidence to support this notion and reiterated in their statement, “Use of any tobacco product must be discouraged.”

The committee also stated that people with psychiatric conditions–especially schizophrenia and major depressive disorder–are more likely to be smokers and to have a harder time quitting, with more severe withdrawal symptoms.

Going forward, patients and providers should be made more aware of the benefits of cessation and the resources for quitting, and reimbursement policies should be established, said the panel.

One antitobacco organization, the Campaign for Tobacco-Free Kids, said it was pleased with the panel's deliberations and statement. “For the most part, they hit all the major issues and, in our opinion, got most of it right,” said Matt Barry, director of policy research for the Washington-based campaign.

Copies of the consensus statement can be found at http://consensus.nih.gov

BETHESDA, MD. – Tobacco cessation programs that employ telephone quit lines and counseling and nicotine replacement therapy are highly effective, and they should be offered to more smokers and users of smokeless tobacco, according to a panel of physicians, other health care providers, and community advocates at a conference on the prevention, cessation, and control of tobacco use sponsored by the National Institutes of Health.

The 14-member panel was charged with issuing a consensus statement on the state of the science after sifting through the available evidence and listening to several days of presentations from the public. The NIH committee found ample evidence that tobacco-related illnesses are a huge burden in the United States–leading to 440,000 deaths each year–and also that there are many successful strategies for preventing use or helping people quit. But there are huge and numerous barriers blocking tobacco users from taking advantage of prevention and cessation programs, the committee added.

Of the 44.5 million adult smokers in the United States, 77% would like to quit, and 40% make an attempt in any given year, according to the panel. But only 5% succeed, mostly because those attempting to quit cannot access effective treatments.

“To increase demand for treatments, we must motivate smokers to want them, expect them, and use them,” said Dr. David F. Ransohoff of the University of North Carolina at Chapel Hill, and chairman of the NIH panel, in a statement.

One of the biggest challenges is stopping people from starting. The data show that most smokers begin in adolescence. Effective strategies to keep children from picking up the habit include raising taxes to increase cigarette prices, passing–and then enforcing–laws to prohibit minors' access to tobacco, and creating smoke-free zones, said the panel. Restricting tobacco ads and promotion and disseminating antitobacco mass media campaigns also work, the committee said.

“Tobacco is a legal product, but it's illegal to sell that product to youth, so simply enforcing the law of not selling tobacco products to youth would help a great deal,” said panelist Stephen B. Thomas, Ph.D., director of the Center for Minority Health at the University of Pittsburgh.

The committee also found that reimbursement for smoking cessation counseling or nicotine replacement products increased physician intervention and encouraged more patients to make use of the services. Patients also are more apt to seek out and use the services when discussions of smoking and quitting are made a routine part of every primary care visit or before every hospital discharge, the panel said.

There was some concern among antitobacco activists that the panel might endorse an idea making the rounds–that people trying to quit smoking could reduce the level of harm by switching to smokeless tobacco. But the committee found limited evidence to support this notion and reiterated in their statement, “Use of any tobacco product must be discouraged.”

The committee also stated that people with psychiatric conditions–especially schizophrenia and major depressive disorder–are more likely to be smokers and to have a harder time quitting, with more severe withdrawal symptoms.

Going forward, patients and providers should be made more aware of the benefits of cessation and the resources for quitting, and reimbursement policies should be established, said the panel.

One antitobacco organization, the Campaign for Tobacco-Free Kids, said it was pleased with the panel's deliberations and statement. “For the most part, they hit all the major issues and, in our opinion, got most of it right,” said Matt Barry, director of policy research for the Washington-based campaign.

Copies of the consensus statement can be found at http://consensus.nih.gov

In a final Medicare coverage decision, regional contractors have been given the leeway to pay for implantation of the Charité artificial lumbar spinal disk, but only in beneficiaries who are younger than 60 years of age—about 6 million people.

The Centers for Medicare and Medicaid Services had originally proposed that the disk not be covered in any circumstances. After examining the evidence, however, CMS decided that although the data were unconvincing and “[did] not provide a sufficient basis for a national coverage decision at this time,” regional Medicare payers could reimburse for the procedure.

CMS also concluded that it would not be reasonable or necessary to cover the Charité disk for people over age 60. That position was supported by the North American Spine Society, the Scoliosis Research Society, and the Spine Arthroplasty Society. The American Association of Neurological Surgeons and the Congress of Neurological Surgeons had argued in comments on the proposal that the surgeon should decide which patients would benefit from the procedure.

CMS was lobbied to cover the procedure for all patients. The agency reported that it received a total of 604 comments, 470 of which were a form letter that had been created by the Texas Back Institute and were signed by patients, family members, and others. The agency said it was “skeptical” of form letters, and that it was not clear how many of the signees were Medicare beneficiaries.

Only seven of the comments overall backed the agency's proposal to not cover the procedure nationally. One physician told CMS that DePuy Spine Inc. was “orchestrating an aggressive letter-writing campaign asking surgeons to write CMS and request that coverage be granted.” Because of the pressure, he said that he felt compelled to come out against coverage.

“I believe that the DePuy strategy is self-serving and is clearly intended to bolster the device's stagnant sales figures,” the physician alleged.

Charité, made by DePuy Spine of Raynham, Mass., was approved in late 2004 for 18- to 60-year-old patients with either level L4/L5 or L5/S1 degenerative disk disease. It has not been studied in patients over the age of 60.

DePuy reported that 5,000 disks have been implanted since its approval, but only 205 procedures have been covered by insurers.

“We hope this decision will provide further support to other insurers of the importance of the Charité as a treatment option for patients with degenerative disk disease,” Dr. Richard Toselli, DePuy worldwide vice president for research and development, said in a statement.

In a final Medicare coverage decision, regional contractors have been given the leeway to pay for implantation of the Charité artificial lumbar spinal disk, but only in beneficiaries who are younger than 60 years of age—about 6 million people.

The Centers for Medicare and Medicaid Services had originally proposed that the disk not be covered in any circumstances. After examining the evidence, however, CMS decided that although the data were unconvincing and “[did] not provide a sufficient basis for a national coverage decision at this time,” regional Medicare payers could reimburse for the procedure.

CMS also concluded that it would not be reasonable or necessary to cover the Charité disk for people over age 60. That position was supported by the North American Spine Society, the Scoliosis Research Society, and the Spine Arthroplasty Society. The American Association of Neurological Surgeons and the Congress of Neurological Surgeons had argued in comments on the proposal that the surgeon should decide which patients would benefit from the procedure.

CMS was lobbied to cover the procedure for all patients. The agency reported that it received a total of 604 comments, 470 of which were a form letter that had been created by the Texas Back Institute and were signed by patients, family members, and others. The agency said it was “skeptical” of form letters, and that it was not clear how many of the signees were Medicare beneficiaries.

Only seven of the comments overall backed the agency's proposal to not cover the procedure nationally. One physician told CMS that DePuy Spine Inc. was “orchestrating an aggressive letter-writing campaign asking surgeons to write CMS and request that coverage be granted.” Because of the pressure, he said that he felt compelled to come out against coverage.

“I believe that the DePuy strategy is self-serving and is clearly intended to bolster the device's stagnant sales figures,” the physician alleged.

Charité, made by DePuy Spine of Raynham, Mass., was approved in late 2004 for 18- to 60-year-old patients with either level L4/L5 or L5/S1 degenerative disk disease. It has not been studied in patients over the age of 60.

DePuy reported that 5,000 disks have been implanted since its approval, but only 205 procedures have been covered by insurers.

“We hope this decision will provide further support to other insurers of the importance of the Charité as a treatment option for patients with degenerative disk disease,” Dr. Richard Toselli, DePuy worldwide vice president for research and development, said in a statement.

In a final Medicare coverage decision, regional contractors have been given the leeway to pay for implantation of the Charité artificial lumbar spinal disk, but only in beneficiaries who are younger than 60 years of age—about 6 million people.

The Centers for Medicare and Medicaid Services had originally proposed that the disk not be covered in any circumstances. After examining the evidence, however, CMS decided that although the data were unconvincing and “[did] not provide a sufficient basis for a national coverage decision at this time,” regional Medicare payers could reimburse for the procedure.

CMS also concluded that it would not be reasonable or necessary to cover the Charité disk for people over age 60. That position was supported by the North American Spine Society, the Scoliosis Research Society, and the Spine Arthroplasty Society. The American Association of Neurological Surgeons and the Congress of Neurological Surgeons had argued in comments on the proposal that the surgeon should decide which patients would benefit from the procedure.

CMS was lobbied to cover the procedure for all patients. The agency reported that it received a total of 604 comments, 470 of which were a form letter that had been created by the Texas Back Institute and were signed by patients, family members, and others. The agency said it was “skeptical” of form letters, and that it was not clear how many of the signees were Medicare beneficiaries.

Only seven of the comments overall backed the agency's proposal to not cover the procedure nationally. One physician told CMS that DePuy Spine Inc. was “orchestrating an aggressive letter-writing campaign asking surgeons to write CMS and request that coverage be granted.” Because of the pressure, he said that he felt compelled to come out against coverage.

“I believe that the DePuy strategy is self-serving and is clearly intended to bolster the device's stagnant sales figures,” the physician alleged.

Charité, made by DePuy Spine of Raynham, Mass., was approved in late 2004 for 18- to 60-year-old patients with either level L4/L5 or L5/S1 degenerative disk disease. It has not been studied in patients over the age of 60.

DePuy reported that 5,000 disks have been implanted since its approval, but only 205 procedures have been covered by insurers.

“We hope this decision will provide further support to other insurers of the importance of the Charité as a treatment option for patients with degenerative disk disease,” Dr. Richard Toselli, DePuy worldwide vice president for research and development, said in a statement.

WASHINGTON — Patient access to technologies such as drug-eluting stents and implantable cardioverter defibrillators may be severely reduced if a Medicare proposal becomes final, physicians and others said at a press conference sponsored by a coalition of device makers, patient advocates, and medical and surgical societies.

The organizations are calling for a 1-year delay in implementation of the Centers for Medicare and Medicaid Services' April proposal to overhaul diagnosis-related group calculations and reduce reimbursement to hospitals for a variety of mostly cardiac procedures. If not delayed, the Hospital Inpatient Prospective Payment System rule would become final in late July or early August and go into effect in October.

“If adopted, this proposal would implement the most dramatic change in hospital payment rules in nearly 20 years,” said Stephen J. Ubl, president and CEO of the Advanced Medical Technology Association (AdvaMed), a medical device lobbying group.

CMS is seeking to move from a charge-based system to a cost-based system. AdvaMed is not opposed to the switch, but CMS's methodology—which will rely on outdated information—is flawed, Mr. Ubl said. For instance, 2007 payments would be based on 2003 cost reports.

Dr. Mark A. Turco, an interventional cardiologist at Washington Adventist Hospital in Takoma Park, Md., who spoke on behalf of the Society for Cardiovascular Angiography and Interventions, noted that drug-eluting stents were not available for most of 2003.

CMS has proposed slashing stent payments by 23%–33%. As a result, the society “is worried that hospitals will inappropriately discourage the use of the newest and most costly technologies,” Dr. Turco said.

He also mentioned that as it stands, CMS pays for implantation of only one drug-eluting stent per vessel and that some hospitals are already limiting how many stents can be used, but that surgeons are pushing those limits—the mean is 1.4–1.7 stents per procedure right now, he said. The concern is that if CMS clamps down further, it might be very hard to use more than one stent in a vessel, even if it's needed.

Thoracic surgeons are concerned the cuts will lead hospitals to put the squeeze on specialty teams that provide invaluable assistance and care, especially in emergent or urgent procedures like transplantation or replacement of infected valves, said Dr. Frederick L. Grover, president of the Society of Thoracic Surgeons.

In a statement, Dr. Dwight W. Reynolds, president of the Heart Rhythm Society, said the proposed cuts for implantable cardioverter defibrillators (22%–24%), pacemakers (12%–15%), and ablations (28%), would not only discourage these procedures, but might also hinder quality improvement efforts. Hospitals could reduce resources devoted to a largely voluntary collection of outcomes data, he said.

The American Hospital Association alerted its members in early June that it did not oppose a return to cost-based payments, but said CMS's methods are flawed. The AHA board recommended a 1-year delay in the rule.

Device maker Medtronic Inc. urged physicians in a letter to write to CMS to oppose the cuts. The new scheme “could reduce patient access to interventional procedures,” wrote Scott R. Ward, president of Medtronic Vascular. “We are confident that a substantive and comprehensive response to the CMS proposal will have an impact,” he wrote.

Dr. Turco noted that the changes will affect care for all patients. “If implemented, these changes may very well make it difficult for physicians to deliver to Medicare beneficiaries, and all patients, the innovative medical care that has led to declines in mortality from cardiovascular disease.”

The cuts would hinder care for all patients, not just those on Medicare, Dr. Mark A. Turco said. Vivian E. Lee/Elsevier Global Medical News

WASHINGTON — Patient access to technologies such as drug-eluting stents and implantable cardioverter defibrillators may be severely reduced if a Medicare proposal becomes final, physicians and others said at a press conference sponsored by a coalition of device makers, patient advocates, and medical and surgical societies.

The organizations are calling for a 1-year delay in implementation of the Centers for Medicare and Medicaid Services' April proposal to overhaul diagnosis-related group calculations and reduce reimbursement to hospitals for a variety of mostly cardiac procedures. If not delayed, the Hospital Inpatient Prospective Payment System rule would become final in late July or early August and go into effect in October.

“If adopted, this proposal would implement the most dramatic change in hospital payment rules in nearly 20 years,” said Stephen J. Ubl, president and CEO of the Advanced Medical Technology Association (AdvaMed), a medical device lobbying group.

CMS is seeking to move from a charge-based system to a cost-based system. AdvaMed is not opposed to the switch, but CMS's methodology—which will rely on outdated information—is flawed, Mr. Ubl said. For instance, 2007 payments would be based on 2003 cost reports.

Dr. Mark A. Turco, an interventional cardiologist at Washington Adventist Hospital in Takoma Park, Md., who spoke on behalf of the Society for Cardiovascular Angiography and Interventions, noted that drug-eluting stents were not available for most of 2003.

CMS has proposed slashing stent payments by 23%–33%. As a result, the society “is worried that hospitals will inappropriately discourage the use of the newest and most costly technologies,” Dr. Turco said.

He also mentioned that as it stands, CMS pays for implantation of only one drug-eluting stent per vessel and that some hospitals are already limiting how many stents can be used, but that surgeons are pushing those limits—the mean is 1.4–1.7 stents per procedure right now, he said. The concern is that if CMS clamps down further, it might be very hard to use more than one stent in a vessel, even if it's needed.

Thoracic surgeons are concerned the cuts will lead hospitals to put the squeeze on specialty teams that provide invaluable assistance and care, especially in emergent or urgent procedures like transplantation or replacement of infected valves, said Dr. Frederick L. Grover, president of the Society of Thoracic Surgeons.

In a statement, Dr. Dwight W. Reynolds, president of the Heart Rhythm Society, said the proposed cuts for implantable cardioverter defibrillators (22%–24%), pacemakers (12%–15%), and ablations (28%), would not only discourage these procedures, but might also hinder quality improvement efforts. Hospitals could reduce resources devoted to a largely voluntary collection of outcomes data, he said.

The American Hospital Association alerted its members in early June that it did not oppose a return to cost-based payments, but said CMS's methods are flawed. The AHA board recommended a 1-year delay in the rule.

Device maker Medtronic Inc. urged physicians in a letter to write to CMS to oppose the cuts. The new scheme “could reduce patient access to interventional procedures,” wrote Scott R. Ward, president of Medtronic Vascular. “We are confident that a substantive and comprehensive response to the CMS proposal will have an impact,” he wrote.

Dr. Turco noted that the changes will affect care for all patients. “If implemented, these changes may very well make it difficult for physicians to deliver to Medicare beneficiaries, and all patients, the innovative medical care that has led to declines in mortality from cardiovascular disease.”

The cuts would hinder care for all patients, not just those on Medicare, Dr. Mark A. Turco said. Vivian E. Lee/Elsevier Global Medical News

WASHINGTON — Patient access to technologies such as drug-eluting stents and implantable cardioverter defibrillators may be severely reduced if a Medicare proposal becomes final, physicians and others said at a press conference sponsored by a coalition of device makers, patient advocates, and medical and surgical societies.

The organizations are calling for a 1-year delay in implementation of the Centers for Medicare and Medicaid Services' April proposal to overhaul diagnosis-related group calculations and reduce reimbursement to hospitals for a variety of mostly cardiac procedures. If not delayed, the Hospital Inpatient Prospective Payment System rule would become final in late July or early August and go into effect in October.

“If adopted, this proposal would implement the most dramatic change in hospital payment rules in nearly 20 years,” said Stephen J. Ubl, president and CEO of the Advanced Medical Technology Association (AdvaMed), a medical device lobbying group.

CMS is seeking to move from a charge-based system to a cost-based system. AdvaMed is not opposed to the switch, but CMS's methodology—which will rely on outdated information—is flawed, Mr. Ubl said. For instance, 2007 payments would be based on 2003 cost reports.

Dr. Mark A. Turco, an interventional cardiologist at Washington Adventist Hospital in Takoma Park, Md., who spoke on behalf of the Society for Cardiovascular Angiography and Interventions, noted that drug-eluting stents were not available for most of 2003.

CMS has proposed slashing stent payments by 23%–33%. As a result, the society “is worried that hospitals will inappropriately discourage the use of the newest and most costly technologies,” Dr. Turco said.

He also mentioned that as it stands, CMS pays for implantation of only one drug-eluting stent per vessel and that some hospitals are already limiting how many stents can be used, but that surgeons are pushing those limits—the mean is 1.4–1.7 stents per procedure right now, he said. The concern is that if CMS clamps down further, it might be very hard to use more than one stent in a vessel, even if it's needed.

Thoracic surgeons are concerned the cuts will lead hospitals to put the squeeze on specialty teams that provide invaluable assistance and care, especially in emergent or urgent procedures like transplantation or replacement of infected valves, said Dr. Frederick L. Grover, president of the Society of Thoracic Surgeons.

In a statement, Dr. Dwight W. Reynolds, president of the Heart Rhythm Society, said the proposed cuts for implantable cardioverter defibrillators (22%–24%), pacemakers (12%–15%), and ablations (28%), would not only discourage these procedures, but might also hinder quality improvement efforts. Hospitals could reduce resources devoted to a largely voluntary collection of outcomes data, he said.

The American Hospital Association alerted its members in early June that it did not oppose a return to cost-based payments, but said CMS's methods are flawed. The AHA board recommended a 1-year delay in the rule.

Device maker Medtronic Inc. urged physicians in a letter to write to CMS to oppose the cuts. The new scheme “could reduce patient access to interventional procedures,” wrote Scott R. Ward, president of Medtronic Vascular. “We are confident that a substantive and comprehensive response to the CMS proposal will have an impact,” he wrote.

Dr. Turco noted that the changes will affect care for all patients. “If implemented, these changes may very well make it difficult for physicians to deliver to Medicare beneficiaries, and all patients, the innovative medical care that has led to declines in mortality from cardiovascular disease.”

The cuts would hinder care for all patients, not just those on Medicare, Dr. Mark A. Turco said. Vivian E. Lee/Elsevier Global Medical News

The Food and Drug Administration has determined that the antibiotic telithromycin (Ketek) may be associated with serious liver injury and liver failure, and has been linked to four deaths and one liver transplant. The drug's maker, Sanofi-Aventis, has upgraded a caution in the drug's label on the potential for liver injury to a bolded warning that serious hepatic injury has been “observed during or immediately after treatment.” Injury has progressed rapidly after just a few doses, according to the company.

Ketek has not received a black box warning, and both the FDA and Sanofi say the drug's benefits outweigh its risks.

“We are advising both patients taking Ketek and their doctors to be on the alert for signs and symptoms of liver problems,” Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research, said in a prepared statement.

However, the drug maker has stopped enrollment in five pediatric trials investigating use of Ketek in acute otitis media, community-acquired pneumonia, and tonsillitis in children 6 months to 18 years old.

The new warning is based partly on an FDA analysis that found that Ketek may be associated with 12 cases of liver failure and four deaths since its approval in 2004. “We're engaged in ongoing discussions with the FDA regarding a detailed medical evaluation of hepatic events reported in connection with Ketek use,” confirmed Sanofi spokeswoman Melissa Feltmann, who would not comment further.

Ketek is currently approved for use in adults to treat community-acquired pneumonia, sinusitis, and acute exacerbation of chronic bronchitis.

“We still believe that the benefit of Ketek outweighs any known risks of the drug when used for its FDA-approved indications,” said Emmy Tsui, another Sanofi spokeswoman.

Ms. Tsui said therapy will continue according to protocol in children already enrolled in the five pediatric trials, but that Sanofi would not enroll any new trial participants until it was certain that its development program “remains consistent with the current thinking of the FDA regarding the structure and design of antibiotic drug development in pediatrics.”

The Senate Finance Committee has been investigating Ketek's approval, as well as a postmarketing safety study that was later found to be fraudulent.

For several months, committee chairman Charles Grassley (R-Iowa), has been complaining that he's been stonewalled by the FDA in his attempts to meet with the agency's special agent who investigated the fraud. In mid-June, he visited the Department of Health and Human Services headquarters to demand such a meeting. Vince Ventimiglia, assistant secretary for legislation at HHS, said the agency has a policy of prohibiting access to lower-level investigators. Sen. Grassley, however, pointed out numerous instances of such investigators talking to the legislative branch, said a spokeswoman for the senator.

The Food and Drug Administration has determined that the antibiotic telithromycin (Ketek) may be associated with serious liver injury and liver failure, and has been linked to four deaths and one liver transplant. The drug's maker, Sanofi-Aventis, has upgraded a caution in the drug's label on the potential for liver injury to a bolded warning that serious hepatic injury has been “observed during or immediately after treatment.” Injury has progressed rapidly after just a few doses, according to the company.

Ketek has not received a black box warning, and both the FDA and Sanofi say the drug's benefits outweigh its risks.

“We are advising both patients taking Ketek and their doctors to be on the alert for signs and symptoms of liver problems,” Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research, said in a prepared statement.

However, the drug maker has stopped enrollment in five pediatric trials investigating use of Ketek in acute otitis media, community-acquired pneumonia, and tonsillitis in children 6 months to 18 years old.

The new warning is based partly on an FDA analysis that found that Ketek may be associated with 12 cases of liver failure and four deaths since its approval in 2004. “We're engaged in ongoing discussions with the FDA regarding a detailed medical evaluation of hepatic events reported in connection with Ketek use,” confirmed Sanofi spokeswoman Melissa Feltmann, who would not comment further.

Ketek is currently approved for use in adults to treat community-acquired pneumonia, sinusitis, and acute exacerbation of chronic bronchitis.

“We still believe that the benefit of Ketek outweighs any known risks of the drug when used for its FDA-approved indications,” said Emmy Tsui, another Sanofi spokeswoman.

Ms. Tsui said therapy will continue according to protocol in children already enrolled in the five pediatric trials, but that Sanofi would not enroll any new trial participants until it was certain that its development program “remains consistent with the current thinking of the FDA regarding the structure and design of antibiotic drug development in pediatrics.”

The Senate Finance Committee has been investigating Ketek's approval, as well as a postmarketing safety study that was later found to be fraudulent.

For several months, committee chairman Charles Grassley (R-Iowa), has been complaining that he's been stonewalled by the FDA in his attempts to meet with the agency's special agent who investigated the fraud. In mid-June, he visited the Department of Health and Human Services headquarters to demand such a meeting. Vince Ventimiglia, assistant secretary for legislation at HHS, said the agency has a policy of prohibiting access to lower-level investigators. Sen. Grassley, however, pointed out numerous instances of such investigators talking to the legislative branch, said a spokeswoman for the senator.

The Food and Drug Administration has determined that the antibiotic telithromycin (Ketek) may be associated with serious liver injury and liver failure, and has been linked to four deaths and one liver transplant. The drug's maker, Sanofi-Aventis, has upgraded a caution in the drug's label on the potential for liver injury to a bolded warning that serious hepatic injury has been “observed during or immediately after treatment.” Injury has progressed rapidly after just a few doses, according to the company.

Ketek has not received a black box warning, and both the FDA and Sanofi say the drug's benefits outweigh its risks.

“We are advising both patients taking Ketek and their doctors to be on the alert for signs and symptoms of liver problems,” Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research, said in a prepared statement.

However, the drug maker has stopped enrollment in five pediatric trials investigating use of Ketek in acute otitis media, community-acquired pneumonia, and tonsillitis in children 6 months to 18 years old.

The new warning is based partly on an FDA analysis that found that Ketek may be associated with 12 cases of liver failure and four deaths since its approval in 2004. “We're engaged in ongoing discussions with the FDA regarding a detailed medical evaluation of hepatic events reported in connection with Ketek use,” confirmed Sanofi spokeswoman Melissa Feltmann, who would not comment further.

Ketek is currently approved for use in adults to treat community-acquired pneumonia, sinusitis, and acute exacerbation of chronic bronchitis.

“We still believe that the benefit of Ketek outweighs any known risks of the drug when used for its FDA-approved indications,” said Emmy Tsui, another Sanofi spokeswoman.

Ms. Tsui said therapy will continue according to protocol in children already enrolled in the five pediatric trials, but that Sanofi would not enroll any new trial participants until it was certain that its development program “remains consistent with the current thinking of the FDA regarding the structure and design of antibiotic drug development in pediatrics.”

The Senate Finance Committee has been investigating Ketek's approval, as well as a postmarketing safety study that was later found to be fraudulent.

For several months, committee chairman Charles Grassley (R-Iowa), has been complaining that he's been stonewalled by the FDA in his attempts to meet with the agency's special agent who investigated the fraud. In mid-June, he visited the Department of Health and Human Services headquarters to demand such a meeting. Vince Ventimiglia, assistant secretary for legislation at HHS, said the agency has a policy of prohibiting access to lower-level investigators. Sen. Grassley, however, pointed out numerous instances of such investigators talking to the legislative branch, said a spokeswoman for the senator.

Physicians as well as patient and industry representatives say that a congressionally imposed reduction in Medicare reimbursement for intravenous immunoglobulin—when combined with several other factors—is having a devastating impact on access to the therapy, leading to more infections and serious illnesses among patients.

The payment scheme went into effect for physician offices in 2005 and for hospitals beginning in January, and was partly a reaction by the Centers for Medicare and Medicaid Services to rising intravenous immunoglobulin (IVIg) use, Bruce Kruger, director of practice and policy for the American Academy of Allergy, Asthma, and Immunology (AAAAI), said in an interview.

The immune therapy is approved for primary immunodeficiency, idiopathic thrombocytopenic purpura, Kawasaki disease, chronic lymphocytic leukemia, pediatric HIV infection, and allogeneic bone marrow transplantation. However, there has been increasing off-label use for infectious diseases; neurologic diseases such as myasthenia gravis, multiple sclerosis, and polymyositis; and hematologic diseases, allergies, and transplantation.

About 17% of the 50,000 people who receive IVIg for primary immune therapy are Medicare eligible and have been the first to start experiencing access issues, said Marcia Boyle, president of the Immune Deficiency Foundation (IDF). Ms. Boyle and Mr. Kruger said that private insurers are following Medicare's lead and also are starting to cut IVIg payments.

At the same time, supplies of the therapy, which takes up to a year to create, have tightened, partly because of rising demand.

From 2000 to 2005, manufacturers increased supplies by 60%, but it still was not enough, Julie Birkhofer, executive director, North America, of the Plasma Protein Therapeutics Association (PPTA), said in an interview.

Another problem: Much of the supply is tied up in physician offices, and they have stopped offering infusions because of the decreased payments.

In a study commissioned by the IVIg Summit Group (which includes the PPTA, IDF, several medical associations, and individual physicians), the Lewin Group found physicians are losing an average $400 per infusion, and losses pile up with increasing infusions. At 10 infusions, a physician would tally a $3,100 loss, according to Lewin.

The IDF and others say that patients have begun migrating to hospitals as physicians shut down infusion services, but that hospitals also are curbing IVIg infusions as the lower reimbursement hits them.

An IDF-funded study presented as a poster at the AAAAI's annual meeting in early March found that 39% of the 202 patients with primary immune deficiencies surveyed said they had problems in getting their IVIg therapy from June 2004 to June 2005, including postponed infusions, increased intervals between infusions, and being switched to a less-tolerated product.

The physician's office is a safer environment than a hospital for an immune-compromised patient. Infusions, usually given monthly, generally cost $5,000.

CMS has been reimbursing physicians for the average sales price plus 6%, and in 2006, added a $69-per-infusion payment to cover administrative costs. In 2005, CMS was paying hospitals 83% of the average wholesale price, which was a slightly higher reimbursement. But in 2006, hospitals also were moved to the average sales price plus 6% rate, which Lewin estimated as a 9% shortfall between the acquisition cost and the Medicare payment, said Ms. Birkhofer. Hospitals were also given an additional $75 for administration.

The PPTA, AAAAI, and others are seeking an add-on payment for the product and to assign Health Care Common Procedure Codes to each brand of IVIg. Currently, all 10 available brands are bundled under one code, giving physicians an incentive to prescribe the lowest-cost IVIg, said Ms. Birkhofer. That can affect patient access and care because not every patient can tolerate the same brand of IVIg, she said.

PPTA has received a legal opinion that CMS can adjust the payment through a rule or some other administrative mechanism.

Mr. Kruger said a payment add-on may be an interim solution, but long term, the demand issue should be addressed. "We're not so naïve to think that all therapy that was being provided was appropriate and necessary," he said.

Physicians as well as patient and industry representatives say that a congressionally imposed reduction in Medicare reimbursement for intravenous immunoglobulin—when combined with several other factors—is having a devastating impact on access to the therapy, leading to more infections and serious illnesses among patients.

The payment scheme went into effect for physician offices in 2005 and for hospitals beginning in January, and was partly a reaction by the Centers for Medicare and Medicaid Services to rising intravenous immunoglobulin (IVIg) use, Bruce Kruger, director of practice and policy for the American Academy of Allergy, Asthma, and Immunology (AAAAI), said in an interview.

The immune therapy is approved for primary immunodeficiency, idiopathic thrombocytopenic purpura, Kawasaki disease, chronic lymphocytic leukemia, pediatric HIV infection, and allogeneic bone marrow transplantation. However, there has been increasing off-label use for infectious diseases; neurologic diseases such as myasthenia gravis, multiple sclerosis, and polymyositis; and hematologic diseases, allergies, and transplantation.

About 17% of the 50,000 people who receive IVIg for primary immune therapy are Medicare eligible and have been the first to start experiencing access issues, said Marcia Boyle, president of the Immune Deficiency Foundation (IDF). Ms. Boyle and Mr. Kruger said that private insurers are following Medicare's lead and also are starting to cut IVIg payments.

At the same time, supplies of the therapy, which takes up to a year to create, have tightened, partly because of rising demand.

From 2000 to 2005, manufacturers increased supplies by 60%, but it still was not enough, Julie Birkhofer, executive director, North America, of the Plasma Protein Therapeutics Association (PPTA), said in an interview.

Another problem: Much of the supply is tied up in physician offices, and they have stopped offering infusions because of the decreased payments.

In a study commissioned by the IVIg Summit Group (which includes the PPTA, IDF, several medical associations, and individual physicians), the Lewin Group found physicians are losing an average $400 per infusion, and losses pile up with increasing infusions. At 10 infusions, a physician would tally a $3,100 loss, according to Lewin.

The IDF and others say that patients have begun migrating to hospitals as physicians shut down infusion services, but that hospitals also are curbing IVIg infusions as the lower reimbursement hits them.

An IDF-funded study presented as a poster at the AAAAI's annual meeting in early March found that 39% of the 202 patients with primary immune deficiencies surveyed said they had problems in getting their IVIg therapy from June 2004 to June 2005, including postponed infusions, increased intervals between infusions, and being switched to a less-tolerated product.

The physician's office is a safer environment than a hospital for an immune-compromised patient. Infusions, usually given monthly, generally cost $5,000.

CMS has been reimbursing physicians for the average sales price plus 6%, and in 2006, added a $69-per-infusion payment to cover administrative costs. In 2005, CMS was paying hospitals 83% of the average wholesale price, which was a slightly higher reimbursement. But in 2006, hospitals also were moved to the average sales price plus 6% rate, which Lewin estimated as a 9% shortfall between the acquisition cost and the Medicare payment, said Ms. Birkhofer. Hospitals were also given an additional $75 for administration.

The PPTA, AAAAI, and others are seeking an add-on payment for the product and to assign Health Care Common Procedure Codes to each brand of IVIg. Currently, all 10 available brands are bundled under one code, giving physicians an incentive to prescribe the lowest-cost IVIg, said Ms. Birkhofer. That can affect patient access and care because not every patient can tolerate the same brand of IVIg, she said.

PPTA has received a legal opinion that CMS can adjust the payment through a rule or some other administrative mechanism.

Mr. Kruger said a payment add-on may be an interim solution, but long term, the demand issue should be addressed. "We're not so naïve to think that all therapy that was being provided was appropriate and necessary," he said.

Physicians as well as patient and industry representatives say that a congressionally imposed reduction in Medicare reimbursement for intravenous immunoglobulin—when combined with several other factors—is having a devastating impact on access to the therapy, leading to more infections and serious illnesses among patients.

The payment scheme went into effect for physician offices in 2005 and for hospitals beginning in January, and was partly a reaction by the Centers for Medicare and Medicaid Services to rising intravenous immunoglobulin (IVIg) use, Bruce Kruger, director of practice and policy for the American Academy of Allergy, Asthma, and Immunology (AAAAI), said in an interview.

The immune therapy is approved for primary immunodeficiency, idiopathic thrombocytopenic purpura, Kawasaki disease, chronic lymphocytic leukemia, pediatric HIV infection, and allogeneic bone marrow transplantation. However, there has been increasing off-label use for infectious diseases; neurologic diseases such as myasthenia gravis, multiple sclerosis, and polymyositis; and hematologic diseases, allergies, and transplantation.

About 17% of the 50,000 people who receive IVIg for primary immune therapy are Medicare eligible and have been the first to start experiencing access issues, said Marcia Boyle, president of the Immune Deficiency Foundation (IDF). Ms. Boyle and Mr. Kruger said that private insurers are following Medicare's lead and also are starting to cut IVIg payments.

At the same time, supplies of the therapy, which takes up to a year to create, have tightened, partly because of rising demand.

From 2000 to 2005, manufacturers increased supplies by 60%, but it still was not enough, Julie Birkhofer, executive director, North America, of the Plasma Protein Therapeutics Association (PPTA), said in an interview.

Another problem: Much of the supply is tied up in physician offices, and they have stopped offering infusions because of the decreased payments.

In a study commissioned by the IVIg Summit Group (which includes the PPTA, IDF, several medical associations, and individual physicians), the Lewin Group found physicians are losing an average $400 per infusion, and losses pile up with increasing infusions. At 10 infusions, a physician would tally a $3,100 loss, according to Lewin.

The IDF and others say that patients have begun migrating to hospitals as physicians shut down infusion services, but that hospitals also are curbing IVIg infusions as the lower reimbursement hits them.

An IDF-funded study presented as a poster at the AAAAI's annual meeting in early March found that 39% of the 202 patients with primary immune deficiencies surveyed said they had problems in getting their IVIg therapy from June 2004 to June 2005, including postponed infusions, increased intervals between infusions, and being switched to a less-tolerated product.

The physician's office is a safer environment than a hospital for an immune-compromised patient. Infusions, usually given monthly, generally cost $5,000.

CMS has been reimbursing physicians for the average sales price plus 6%, and in 2006, added a $69-per-infusion payment to cover administrative costs. In 2005, CMS was paying hospitals 83% of the average wholesale price, which was a slightly higher reimbursement. But in 2006, hospitals also were moved to the average sales price plus 6% rate, which Lewin estimated as a 9% shortfall between the acquisition cost and the Medicare payment, said Ms. Birkhofer. Hospitals were also given an additional $75 for administration.

The PPTA, AAAAI, and others are seeking an add-on payment for the product and to assign Health Care Common Procedure Codes to each brand of IVIg. Currently, all 10 available brands are bundled under one code, giving physicians an incentive to prescribe the lowest-cost IVIg, said Ms. Birkhofer. That can affect patient access and care because not every patient can tolerate the same brand of IVIg, she said.

PPTA has received a legal opinion that CMS can adjust the payment through a rule or some other administrative mechanism.

Mr. Kruger said a payment add-on may be an interim solution, but long term, the demand issue should be addressed. "We're not so naïve to think that all therapy that was being provided was appropriate and necessary," he said.

In an assessment of performance by one of the nation's largest physician revenue management companies, Humana and Medicare were rated highest when it came to paying quickly and being easy to work with.

The performance data were tabulated and made public by AthenaHealth, a Watertown, Mass.-based company that manages $2 billion in revenues for 7,000 physicians, nurses, and other health care providers in 33 states.

In explaining why the company decided to make the data available free of charge, Jeremy Delinsky, director of process innovation at AthenaHealth, said, "We were a little skittish about making it public, but we found the story was too compelling to sit on." And, physicians who know more about their insurers will have more leverage in contracting and a better opportunity to improve their bottom line, he said.

The company assessed 5 million "charge lines" worth of claims data from the fourth quarter of 2005. To be a part of the ranking, national payers had to have at least 10,000 "charge lines," or line items, and regional payers at least 3,000.

Insurers were ranked according to an overall index that gave the most weight to financial performance. That performance included days in accounts receivable, percentage of claims paid and closed on the first pass, and percentage of charges transferred to the patient.

In addition to financial performance, the index included an administrative measure encompassing the claims denial rate, the percentage requiring a phone call to clarify a response from the insurer, and the percentage of claims lost. Finally, a small amount of weight was given to the difficulty of working within the payer's rules.

Nationally, Humana ranked number one, followed by Medicare, United Health Group, Aetna, Cigna, Champus, and Wellpoint. According to AthenaHealth, Aetna denies claims twice as often as Humana, and the reasons are so unclear that 17% of claims need follow-up calls. Wellpoint tended to take the longest to pay, and more than any other payer, the company aggressively shifts responsibility to physicians to get payment from the patient.

For all payers, claims stay in accounts receivable for an average of 38 days.

On the regional level, there was a wide variation in performance.

In the northeast, for example, BlueCross BlueShield of Pennsylvania/Independence BlueCross was the top-ranked plan, followed by Tufts Health Plan and Fallon Health Plan. In the west, PacifiCare was first, followed by Medicare B in Texas and United Health Group. The largest regional payers mostly provided clear reasons for denials, rarely shifted the responsibility to physicians to secure payment, and paid most claims upon first submission and within 30 days.

Regional payers appeared to be more efficient and perhaps even more powerful than the national insurers, said Mr. Delinsky. National payers have been growing in size, but "it's unclear to us whether consolidation has resulted in the scale they hoped for," he said.

AthenaHealth did not assess payers' relative reimbursement rates because it would not be legal to publicize those rates, Mr. Delinsky said. However, he suggested that physicians could use his company's rankings to negotiate for a higher fee if the payer is hard to work with, or potentially accept a lower payment rate if the insurer pays more quickly and imposes less of an administrative burden.

The insurance industry did not respond directly to the rankings, but America's Health Insurance Plans, a national trade association, completed a study recently showing that 98% of claims submitted electronically are processed within a month of receipt. The study, based on aggregated data from 25 million claims processed by a sample of 26 health insurers, found that 75% of all claims are submitted electronically, up from 24% in 1995.

If there is a delay in payment, it's often because the claim has not been received in a timely manner from the physician's office, according to AHIP. The group said that 3 in 10 claims were received more than 30 days after the date of service. Paper claims are more likely to get held up. A third of paper claims took 60 days or more to reach the payer, said AHIP.

The rankings are posted at www.athenapayerview.com

In an assessment of performance by one of the nation's largest physician revenue management companies, Humana and Medicare were rated highest when it came to paying quickly and being easy to work with.

The performance data were tabulated and made public by AthenaHealth, a Watertown, Mass.-based company that manages $2 billion in revenues for 7,000 physicians, nurses, and other health care providers in 33 states.

In explaining why the company decided to make the data available free of charge, Jeremy Delinsky, director of process innovation at AthenaHealth, said, "We were a little skittish about making it public, but we found the story was too compelling to sit on." And, physicians who know more about their insurers will have more leverage in contracting and a better opportunity to improve their bottom line, he said.

The company assessed 5 million "charge lines" worth of claims data from the fourth quarter of 2005. To be a part of the ranking, national payers had to have at least 10,000 "charge lines," or line items, and regional payers at least 3,000.

Insurers were ranked according to an overall index that gave the most weight to financial performance. That performance included days in accounts receivable, percentage of claims paid and closed on the first pass, and percentage of charges transferred to the patient.

In addition to financial performance, the index included an administrative measure encompassing the claims denial rate, the percentage requiring a phone call to clarify a response from the insurer, and the percentage of claims lost. Finally, a small amount of weight was given to the difficulty of working within the payer's rules.

Nationally, Humana ranked number one, followed by Medicare, United Health Group, Aetna, Cigna, Champus, and Wellpoint. According to AthenaHealth, Aetna denies claims twice as often as Humana, and the reasons are so unclear that 17% of claims need follow-up calls. Wellpoint tended to take the longest to pay, and more than any other payer, the company aggressively shifts responsibility to physicians to get payment from the patient.

For all payers, claims stay in accounts receivable for an average of 38 days.

On the regional level, there was a wide variation in performance.

In the northeast, for example, BlueCross BlueShield of Pennsylvania/Independence BlueCross was the top-ranked plan, followed by Tufts Health Plan and Fallon Health Plan. In the west, PacifiCare was first, followed by Medicare B in Texas and United Health Group. The largest regional payers mostly provided clear reasons for denials, rarely shifted the responsibility to physicians to secure payment, and paid most claims upon first submission and within 30 days.

Regional payers appeared to be more efficient and perhaps even more powerful than the national insurers, said Mr. Delinsky. National payers have been growing in size, but "it's unclear to us whether consolidation has resulted in the scale they hoped for," he said.

AthenaHealth did not assess payers' relative reimbursement rates because it would not be legal to publicize those rates, Mr. Delinsky said. However, he suggested that physicians could use his company's rankings to negotiate for a higher fee if the payer is hard to work with, or potentially accept a lower payment rate if the insurer pays more quickly and imposes less of an administrative burden.

The insurance industry did not respond directly to the rankings, but America's Health Insurance Plans, a national trade association, completed a study recently showing that 98% of claims submitted electronically are processed within a month of receipt. The study, based on aggregated data from 25 million claims processed by a sample of 26 health insurers, found that 75% of all claims are submitted electronically, up from 24% in 1995.

If there is a delay in payment, it's often because the claim has not been received in a timely manner from the physician's office, according to AHIP. The group said that 3 in 10 claims were received more than 30 days after the date of service. Paper claims are more likely to get held up. A third of paper claims took 60 days or more to reach the payer, said AHIP.

The rankings are posted at www.athenapayerview.com

In an assessment of performance by one of the nation's largest physician revenue management companies, Humana and Medicare were rated highest when it came to paying quickly and being easy to work with.

The performance data were tabulated and made public by AthenaHealth, a Watertown, Mass.-based company that manages $2 billion in revenues for 7,000 physicians, nurses, and other health care providers in 33 states.

In explaining why the company decided to make the data available free of charge, Jeremy Delinsky, director of process innovation at AthenaHealth, said, "We were a little skittish about making it public, but we found the story was too compelling to sit on." And, physicians who know more about their insurers will have more leverage in contracting and a better opportunity to improve their bottom line, he said.

The company assessed 5 million "charge lines" worth of claims data from the fourth quarter of 2005. To be a part of the ranking, national payers had to have at least 10,000 "charge lines," or line items, and regional payers at least 3,000.

Insurers were ranked according to an overall index that gave the most weight to financial performance. That performance included days in accounts receivable, percentage of claims paid and closed on the first pass, and percentage of charges transferred to the patient.

In addition to financial performance, the index included an administrative measure encompassing the claims denial rate, the percentage requiring a phone call to clarify a response from the insurer, and the percentage of claims lost. Finally, a small amount of weight was given to the difficulty of working within the payer's rules.

Nationally, Humana ranked number one, followed by Medicare, United Health Group, Aetna, Cigna, Champus, and Wellpoint. According to AthenaHealth, Aetna denies claims twice as often as Humana, and the reasons are so unclear that 17% of claims need follow-up calls. Wellpoint tended to take the longest to pay, and more than any other payer, the company aggressively shifts responsibility to physicians to get payment from the patient.

For all payers, claims stay in accounts receivable for an average of 38 days.

On the regional level, there was a wide variation in performance.

In the northeast, for example, BlueCross BlueShield of Pennsylvania/Independence BlueCross was the top-ranked plan, followed by Tufts Health Plan and Fallon Health Plan. In the west, PacifiCare was first, followed by Medicare B in Texas and United Health Group. The largest regional payers mostly provided clear reasons for denials, rarely shifted the responsibility to physicians to secure payment, and paid most claims upon first submission and within 30 days.

Regional payers appeared to be more efficient and perhaps even more powerful than the national insurers, said Mr. Delinsky. National payers have been growing in size, but "it's unclear to us whether consolidation has resulted in the scale they hoped for," he said.

AthenaHealth did not assess payers' relative reimbursement rates because it would not be legal to publicize those rates, Mr. Delinsky said. However, he suggested that physicians could use his company's rankings to negotiate for a higher fee if the payer is hard to work with, or potentially accept a lower payment rate if the insurer pays more quickly and imposes less of an administrative burden.

The insurance industry did not respond directly to the rankings, but America's Health Insurance Plans, a national trade association, completed a study recently showing that 98% of claims submitted electronically are processed within a month of receipt. The study, based on aggregated data from 25 million claims processed by a sample of 26 health insurers, found that 75% of all claims are submitted electronically, up from 24% in 1995.

If there is a delay in payment, it's often because the claim has not been received in a timely manner from the physician's office, according to AHIP. The group said that 3 in 10 claims were received more than 30 days after the date of service. Paper claims are more likely to get held up. A third of paper claims took 60 days or more to reach the payer, said AHIP.

The rankings are posted at www.athenapayerview.com

Dermatologists and Statistics

Apparently, dermatologists are lacking when it comes to appropriately using statistical methods and interpreting results—but not any more so than physicians in other specialties, according to a recent review of studies in the Archives of Dermatology and the Journal of the American Academy of Dermatology by researchers at Wake Forest University. They found that 38% (59) of 155 articles that used statistical analyses either had errors in the methods or omissions in reporting of results. They reviewed original studies from January through December 2003. Twenty-two studies erred in use of a statistical test, thus possibly changing the validity of results; 41 presented results incorrectly, and 4 had errors in both test use and presentation. Thirty-eight were in the Journal of the American Academy of Dermatology and 21 were in the Archives of Dermatology. To reduce errors, perhaps all papers should be reviewed by a statistician before submission, and statistics training should be added to dermatology residency programs, suggested the authors. The paper was published in the June 2006 Archives of Dermatology.

Supplement Side Effects

Dietary supplement makers and producers of over-the-counter drugs would be required to report serious adverse events to the Food and Drug Administration within 15 business days, under the Dietary Supplement and Nonprescription Drug Consumer Protection Act (S. 3456), currently pending in the U.S. Senate. Events would include death, a life-threatening experience, hospitalization, disability, or a birth defect. Retailers would not be required to report the events. The bill was introduced by strange bedfellows: Sen. Orrin Hatch (R-Utah), who crafted the 1994 Dietary Supplement Health and Education Act (DSHEA), which is widely seen as a loophole for the products, along with two frequent critics of DSHEA: Sen. Tom Harkin (D-Iowa) and Sen. Richard Durbin (D-Ill.). The proposal also has the backing of consumer advocates such as Consumer Reports and the Center for Science in the Public Interest, and of industry groups, including the Consumer Healthcare Products Association, the American Herbal Products Association, the Council for Responsible Nutrition, and the National Nutritional Foods Association. The bill could be on a fast track to approval; it was accepted and reported out of the Senate Health, Education, Labor and Pension Committee earlier this summer and now will go before the full Senate.

Postmarketing Study Failure

The Food and Drug Administration is doing a poor job of ensuring that pharmaceutical companies live up to postmarketing study commitments, according to a new report by the Department of Health and Human Services' Office of Inspector General. Among the findings: that the FDA can't easily identify if the studies are progressing or what stage they are in; and that monitoring postmarketing studies "is not a top priority at FDA." The IG reviewed new drug applications from 1990 to 2004; 48% of those applications had at least one postmarketing study commitment. Drugmakers are required to submit annual status reports. The IG found that 35% of the reports that should have been submitted in fiscal 2004 were missing or had no information on the study commitments. The IG noted that the FDA has limited enforcement power in this area, but suggested that the agency require more, and more relevant, information from drugmakers. In response, FDA said it could not do that without additional regulations, but agreed that it needed to do more to improve its monitoring and to ensure that commitments are honored and that annual reports are thorough.

Part D Drug Price Increase

The advocacy group Families USA says almost all the plans participating in Medicare Part D drug coverage raised prices from November 2005 to April 2006 for pharmaceuticals frequently used by seniors. The data are compiled from pricing reports submitted to the Center for Medicare and Medicaid Services. All the plans raised prices for Zocor (simvastatin), and most did so for Fosamax (alendronate), Actonel (risedronate), Nexium (esomeprazole), and Norvasc (amlodipine). The median price increase for the top 20 drugs used by seniors was 3.7%, said Families USA. Increases for Celebrex (celecoxib), Lipitor (atorvastatin), and Aricept (donepezil) were 6%. During the November-April time period, the median price increases for the Part D plans "were virtually identical to changes in manufacturer prices as measured by average wholesale price (AWP)," according to the report. "This means that Part D plans are doing essentially nothing to contain the fast-rising prices by the drug industry," said Ron Pollack, executive director of the group, in a statement. CMS, however, said that its analysis showed that Part D plan prices rose 3.6% on average while AWPs rose 4.1%, resulting in savings to taxpayers.

Physicians' Income Drops

The average net income for physicians dropped by about 7% from 1995 to 2003 after adjusting for inflation, even as incomes for other professionals increased, according to a survey conducted by the Center for Studying Health System Change. Primary care physicians have experienced the biggest decline, with average net incomes dropping 10.2% after adjusting for inflation. Surgical specialists also saw a significant decrease in inflation-adjusted earnings, with an 8.2% drop in net income from 1995 to 2003. Medical specialists had a 2.1% decrease, but this change was not statistically significant.

Dermatologists and Statistics

Apparently, dermatologists are lacking when it comes to appropriately using statistical methods and interpreting results—but not any more so than physicians in other specialties, according to a recent review of studies in the Archives of Dermatology and the Journal of the American Academy of Dermatology by researchers at Wake Forest University. They found that 38% (59) of 155 articles that used statistical analyses either had errors in the methods or omissions in reporting of results. They reviewed original studies from January through December 2003. Twenty-two studies erred in use of a statistical test, thus possibly changing the validity of results; 41 presented results incorrectly, and 4 had errors in both test use and presentation. Thirty-eight were in the Journal of the American Academy of Dermatology and 21 were in the Archives of Dermatology. To reduce errors, perhaps all papers should be reviewed by a statistician before submission, and statistics training should be added to dermatology residency programs, suggested the authors. The paper was published in the June 2006 Archives of Dermatology.

Supplement Side Effects

Dietary supplement makers and producers of over-the-counter drugs would be required to report serious adverse events to the Food and Drug Administration within 15 business days, under the Dietary Supplement and Nonprescription Drug Consumer Protection Act (S. 3456), currently pending in the U.S. Senate. Events would include death, a life-threatening experience, hospitalization, disability, or a birth defect. Retailers would not be required to report the events. The bill was introduced by strange bedfellows: Sen. Orrin Hatch (R-Utah), who crafted the 1994 Dietary Supplement Health and Education Act (DSHEA), which is widely seen as a loophole for the products, along with two frequent critics of DSHEA: Sen. Tom Harkin (D-Iowa) and Sen. Richard Durbin (D-Ill.). The proposal also has the backing of consumer advocates such as Consumer Reports and the Center for Science in the Public Interest, and of industry groups, including the Consumer Healthcare Products Association, the American Herbal Products Association, the Council for Responsible Nutrition, and the National Nutritional Foods Association. The bill could be on a fast track to approval; it was accepted and reported out of the Senate Health, Education, Labor and Pension Committee earlier this summer and now will go before the full Senate.

Postmarketing Study Failure

The Food and Drug Administration is doing a poor job of ensuring that pharmaceutical companies live up to postmarketing study commitments, according to a new report by the Department of Health and Human Services' Office of Inspector General. Among the findings: that the FDA can't easily identify if the studies are progressing or what stage they are in; and that monitoring postmarketing studies "is not a top priority at FDA." The IG reviewed new drug applications from 1990 to 2004; 48% of those applications had at least one postmarketing study commitment. Drugmakers are required to submit annual status reports. The IG found that 35% of the reports that should have been submitted in fiscal 2004 were missing or had no information on the study commitments. The IG noted that the FDA has limited enforcement power in this area, but suggested that the agency require more, and more relevant, information from drugmakers. In response, FDA said it could not do that without additional regulations, but agreed that it needed to do more to improve its monitoring and to ensure that commitments are honored and that annual reports are thorough.

Part D Drug Price Increase

The advocacy group Families USA says almost all the plans participating in Medicare Part D drug coverage raised prices from November 2005 to April 2006 for pharmaceuticals frequently used by seniors. The data are compiled from pricing reports submitted to the Center for Medicare and Medicaid Services. All the plans raised prices for Zocor (simvastatin), and most did so for Fosamax (alendronate), Actonel (risedronate), Nexium (esomeprazole), and Norvasc (amlodipine). The median price increase for the top 20 drugs used by seniors was 3.7%, said Families USA. Increases for Celebrex (celecoxib), Lipitor (atorvastatin), and Aricept (donepezil) were 6%. During the November-April time period, the median price increases for the Part D plans "were virtually identical to changes in manufacturer prices as measured by average wholesale price (AWP)," according to the report. "This means that Part D plans are doing essentially nothing to contain the fast-rising prices by the drug industry," said Ron Pollack, executive director of the group, in a statement. CMS, however, said that its analysis showed that Part D plan prices rose 3.6% on average while AWPs rose 4.1%, resulting in savings to taxpayers.

Physicians' Income Drops

The average net income for physicians dropped by about 7% from 1995 to 2003 after adjusting for inflation, even as incomes for other professionals increased, according to a survey conducted by the Center for Studying Health System Change. Primary care physicians have experienced the biggest decline, with average net incomes dropping 10.2% after adjusting for inflation. Surgical specialists also saw a significant decrease in inflation-adjusted earnings, with an 8.2% drop in net income from 1995 to 2003. Medical specialists had a 2.1% decrease, but this change was not statistically significant.

Dermatologists and Statistics

Apparently, dermatologists are lacking when it comes to appropriately using statistical methods and interpreting results—but not any more so than physicians in other specialties, according to a recent review of studies in the Archives of Dermatology and the Journal of the American Academy of Dermatology by researchers at Wake Forest University. They found that 38% (59) of 155 articles that used statistical analyses either had errors in the methods or omissions in reporting of results. They reviewed original studies from January through December 2003. Twenty-two studies erred in use of a statistical test, thus possibly changing the validity of results; 41 presented results incorrectly, and 4 had errors in both test use and presentation. Thirty-eight were in the Journal of the American Academy of Dermatology and 21 were in the Archives of Dermatology. To reduce errors, perhaps all papers should be reviewed by a statistician before submission, and statistics training should be added to dermatology residency programs, suggested the authors. The paper was published in the June 2006 Archives of Dermatology.

Supplement Side Effects

Dietary supplement makers and producers of over-the-counter drugs would be required to report serious adverse events to the Food and Drug Administration within 15 business days, under the Dietary Supplement and Nonprescription Drug Consumer Protection Act (S. 3456), currently pending in the U.S. Senate. Events would include death, a life-threatening experience, hospitalization, disability, or a birth defect. Retailers would not be required to report the events. The bill was introduced by strange bedfellows: Sen. Orrin Hatch (R-Utah), who crafted the 1994 Dietary Supplement Health and Education Act (DSHEA), which is widely seen as a loophole for the products, along with two frequent critics of DSHEA: Sen. Tom Harkin (D-Iowa) and Sen. Richard Durbin (D-Ill.). The proposal also has the backing of consumer advocates such as Consumer Reports and the Center for Science in the Public Interest, and of industry groups, including the Consumer Healthcare Products Association, the American Herbal Products Association, the Council for Responsible Nutrition, and the National Nutritional Foods Association. The bill could be on a fast track to approval; it was accepted and reported out of the Senate Health, Education, Labor and Pension Committee earlier this summer and now will go before the full Senate.

Postmarketing Study Failure

The Food and Drug Administration is doing a poor job of ensuring that pharmaceutical companies live up to postmarketing study commitments, according to a new report by the Department of Health and Human Services' Office of Inspector General. Among the findings: that the FDA can't easily identify if the studies are progressing or what stage they are in; and that monitoring postmarketing studies "is not a top priority at FDA." The IG reviewed new drug applications from 1990 to 2004; 48% of those applications had at least one postmarketing study commitment. Drugmakers are required to submit annual status reports. The IG found that 35% of the reports that should have been submitted in fiscal 2004 were missing or had no information on the study commitments. The IG noted that the FDA has limited enforcement power in this area, but suggested that the agency require more, and more relevant, information from drugmakers. In response, FDA said it could not do that without additional regulations, but agreed that it needed to do more to improve its monitoring and to ensure that commitments are honored and that annual reports are thorough.

Part D Drug Price Increase

The advocacy group Families USA says almost all the plans participating in Medicare Part D drug coverage raised prices from November 2005 to April 2006 for pharmaceuticals frequently used by seniors. The data are compiled from pricing reports submitted to the Center for Medicare and Medicaid Services. All the plans raised prices for Zocor (simvastatin), and most did so for Fosamax (alendronate), Actonel (risedronate), Nexium (esomeprazole), and Norvasc (amlodipine). The median price increase for the top 20 drugs used by seniors was 3.7%, said Families USA. Increases for Celebrex (celecoxib), Lipitor (atorvastatin), and Aricept (donepezil) were 6%. During the November-April time period, the median price increases for the Part D plans "were virtually identical to changes in manufacturer prices as measured by average wholesale price (AWP)," according to the report. "This means that Part D plans are doing essentially nothing to contain the fast-rising prices by the drug industry," said Ron Pollack, executive director of the group, in a statement. CMS, however, said that its analysis showed that Part D plan prices rose 3.6% on average while AWPs rose 4.1%, resulting in savings to taxpayers.

Physicians' Income Drops

The average net income for physicians dropped by about 7% from 1995 to 2003 after adjusting for inflation, even as incomes for other professionals increased, according to a survey conducted by the Center for Studying Health System Change. Primary care physicians have experienced the biggest decline, with average net incomes dropping 10.2% after adjusting for inflation. Surgical specialists also saw a significant decrease in inflation-adjusted earnings, with an 8.2% drop in net income from 1995 to 2003. Medical specialists had a 2.1% decrease, but this change was not statistically significant.

The Food and Drug Administration announced that it is renewing efforts to ensure that all drugs currently sold by prescription either go through its formal approval process or be taken off the market.

The agency has periodically targeted some of these products using its existing authority. Now, the FDA has issued more formal guidance that spells out for manufacturers how it will prioritize enforcement, and what route they can take to prove safety and efficacy of their products.

There are many reasons why unapproved products are on the market, said Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research, at a press briefing sponsored by the agency.

Most were marketed before passage of the 1962 Food, Drug, and Cosmetic Act, which required formal proof of safety and efficacy. Or their makers may simply have begun selling the products without seeking the agency's approval, he said, noting that the FDA will issue a new drug code number for a product even if it was never approved.

Many of the unapproved drugs are listed in the Physicians' Desk Reference. Some are advertised in medical journals. Those initially flagged for attention include products that are potentially hazardous, lack evidence of effectiveness, or appear fraudulent. If the manufacturers don't seek approval, they will be subject to enforcement action, Dr. Galson said. But in most cases, the FDA will not remove a drug from the market if it has been shown to have some medical utility. Examples include some manufacturers' levothyroxine and phenobarbital products.

The agency estimates that less than 2% of prescription drugs have not received its imprimatur. That still means potentially thousands of products that aren't approved.

Many of the drugs are cough and cold preparations that include pheniramine maleate and dexbrompheniramine maleate, or single-ingredient narcotics such as codeine phosphate and oxycodone HCl. Sedatives like chloral hydrate are also unapproved.

The agency recently announced that it is requiring makers of carbinoxamine-containing products to seek approval by late September. Any unapproved products still on the shelves at that date will be ordered off the market, said Deborah M. Autor, FDA associate director for compliance policy.

The FDA said it was targeting carbinoxamine because of safety concerns, including 21 deaths since 1983 in children under age 2 that may be related to the ingredient. Carbinoxamine is used in cough and cold treatments, mostly for children.

Physicians, pharmacists, and patients can go to the FDA's Web site (www.accessdata.fda.gov/scripts/cder/drugsatfda

The Food and Drug Administration announced that it is renewing efforts to ensure that all drugs currently sold by prescription either go through its formal approval process or be taken off the market.

The agency has periodically targeted some of these products using its existing authority. Now, the FDA has issued more formal guidance that spells out for manufacturers how it will prioritize enforcement, and what route they can take to prove safety and efficacy of their products.

There are many reasons why unapproved products are on the market, said Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research, at a press briefing sponsored by the agency.

Most were marketed before passage of the 1962 Food, Drug, and Cosmetic Act, which required formal proof of safety and efficacy. Or their makers may simply have begun selling the products without seeking the agency's approval, he said, noting that the FDA will issue a new drug code number for a product even if it was never approved.

Many of the unapproved drugs are listed in the Physicians' Desk Reference. Some are advertised in medical journals. Those initially flagged for attention include products that are potentially hazardous, lack evidence of effectiveness, or appear fraudulent. If the manufacturers don't seek approval, they will be subject to enforcement action, Dr. Galson said. But in most cases, the FDA will not remove a drug from the market if it has been shown to have some medical utility. Examples include some manufacturers' levothyroxine and phenobarbital products.

The agency estimates that less than 2% of prescription drugs have not received its imprimatur. That still means potentially thousands of products that aren't approved.

Many of the drugs are cough and cold preparations that include pheniramine maleate and dexbrompheniramine maleate, or single-ingredient narcotics such as codeine phosphate and oxycodone HCl. Sedatives like chloral hydrate are also unapproved.

The agency recently announced that it is requiring makers of carbinoxamine-containing products to seek approval by late September. Any unapproved products still on the shelves at that date will be ordered off the market, said Deborah M. Autor, FDA associate director for compliance policy.

The FDA said it was targeting carbinoxamine because of safety concerns, including 21 deaths since 1983 in children under age 2 that may be related to the ingredient. Carbinoxamine is used in cough and cold treatments, mostly for children.

Physicians, pharmacists, and patients can go to the FDA's Web site (www.accessdata.fda.gov/scripts/cder/drugsatfda

The Food and Drug Administration announced that it is renewing efforts to ensure that all drugs currently sold by prescription either go through its formal approval process or be taken off the market.

The agency has periodically targeted some of these products using its existing authority. Now, the FDA has issued more formal guidance that spells out for manufacturers how it will prioritize enforcement, and what route they can take to prove safety and efficacy of their products.

There are many reasons why unapproved products are on the market, said Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research, at a press briefing sponsored by the agency.

Most were marketed before passage of the 1962 Food, Drug, and Cosmetic Act, which required formal proof of safety and efficacy. Or their makers may simply have begun selling the products without seeking the agency's approval, he said, noting that the FDA will issue a new drug code number for a product even if it was never approved.

Many of the unapproved drugs are listed in the Physicians' Desk Reference. Some are advertised in medical journals. Those initially flagged for attention include products that are potentially hazardous, lack evidence of effectiveness, or appear fraudulent. If the manufacturers don't seek approval, they will be subject to enforcement action, Dr. Galson said. But in most cases, the FDA will not remove a drug from the market if it has been shown to have some medical utility. Examples include some manufacturers' levothyroxine and phenobarbital products.

The agency estimates that less than 2% of prescription drugs have not received its imprimatur. That still means potentially thousands of products that aren't approved.

Many of the drugs are cough and cold preparations that include pheniramine maleate and dexbrompheniramine maleate, or single-ingredient narcotics such as codeine phosphate and oxycodone HCl. Sedatives like chloral hydrate are also unapproved.

The agency recently announced that it is requiring makers of carbinoxamine-containing products to seek approval by late September. Any unapproved products still on the shelves at that date will be ordered off the market, said Deborah M. Autor, FDA associate director for compliance policy.

The FDA said it was targeting carbinoxamine because of safety concerns, including 21 deaths since 1983 in children under age 2 that may be related to the ingredient. Carbinoxamine is used in cough and cold treatments, mostly for children.

Physicians, pharmacists, and patients can go to the FDA's Web site (www.accessdata.fda.gov/scripts/cder/drugsatfda