Alicia Ault

WASHINGTON — Merck's experimental RotaTeq vaccine was effective against moderate and severe rotavirus at the end of its shelf life, which appears to be 18 months, lead investigator Umesh Parashar, M.D., reported at the National Immunization Conference sponsored by the Centers for Disease Control and Prevention.

A new vaccine is eagerly anticipated, because rotavirus causes 440,000 deaths and leads to 2.1 million inpatient visits in children under age 5 worldwide each year, said Dr. Parashar of the National Center for Infectious Diseases at the Centers for Disease Control and Prevention (CDC). Rotavirus causes 5% of deaths in children under age 5 worldwide. In the United States, there are few deaths—only 20-60 per year—but there are 200,000-272,000 emergency department visits and 400,000 outpatient visits because of rotavirus annually.

Stan Block, M.D., a pediatrician in private practice in Bardstown, Ky., presented the RotaTeq data on behalf of trial sites in the United States and Finland.

RotaTeq is a pentavalent oral vaccine, aiming to provide protection against the G1, G2, G3, G4, and P1 strains.

From 2002 to 2004, 1,310 healthy infants aged 6-12 weeks were assigned to receive three doses of RotaTeq (at the end of shelf life) or placebo. The doses were given 4-10 weeks apart. Children with a gastrointestinal disorder, recent surgery, or acute fever or who had taken steroids within 2 weeks of the trial were excluded. RotaTeq could be given simultaneously with other vaccines, said Dr. Block.

Children were monitored for acute gastroenteritis through one rotavirus season.

There were 69 cases of rotavirus, for an overall efficacy of 72.5%. For severe acute gastroenteritis, the vaccine was 100% effective, and for both moderate and severe gastroenteritis, it was 76.3% effective.

The vaccine also appeared to be very safe. There were five potential cases of intussusception (all were in the placebo group), but all were negatively adjudicated by an independent safety monitoring board, Dr. Block said.

Children who received RotaTeq did have a statistically significant increase in temperature after the first dose, compared with placebo—13.4% of RotaTeq vaccinees, compared with 8.8% of placebo recipients. However, there was no increase in rates of fever after the second or third dose, he said. Only one child was documented to have a rotavirus vaccine strain a few days after the first dose of vaccine.

Merck is continuing a larger, 70,000-patient safety study. Preliminary results were presented at the CDC's Advisory Committee on Immunization Practices meeting in February, said Penny Heaton, director of clinical research at Merck.

So far, there have been 12 cases of intussusception in the RotaTeq group and 15 in the placebo group, she said.

WASHINGTON — Merck's experimental RotaTeq vaccine was effective against moderate and severe rotavirus at the end of its shelf life, which appears to be 18 months, lead investigator Umesh Parashar, M.D., reported at the National Immunization Conference sponsored by the Centers for Disease Control and Prevention.

A new vaccine is eagerly anticipated, because rotavirus causes 440,000 deaths and leads to 2.1 million inpatient visits in children under age 5 worldwide each year, said Dr. Parashar of the National Center for Infectious Diseases at the Centers for Disease Control and Prevention (CDC). Rotavirus causes 5% of deaths in children under age 5 worldwide. In the United States, there are few deaths—only 20-60 per year—but there are 200,000-272,000 emergency department visits and 400,000 outpatient visits because of rotavirus annually.

Stan Block, M.D., a pediatrician in private practice in Bardstown, Ky., presented the RotaTeq data on behalf of trial sites in the United States and Finland.

RotaTeq is a pentavalent oral vaccine, aiming to provide protection against the G1, G2, G3, G4, and P1 strains.

From 2002 to 2004, 1,310 healthy infants aged 6-12 weeks were assigned to receive three doses of RotaTeq (at the end of shelf life) or placebo. The doses were given 4-10 weeks apart. Children with a gastrointestinal disorder, recent surgery, or acute fever or who had taken steroids within 2 weeks of the trial were excluded. RotaTeq could be given simultaneously with other vaccines, said Dr. Block.

Children were monitored for acute gastroenteritis through one rotavirus season.

There were 69 cases of rotavirus, for an overall efficacy of 72.5%. For severe acute gastroenteritis, the vaccine was 100% effective, and for both moderate and severe gastroenteritis, it was 76.3% effective.

The vaccine also appeared to be very safe. There were five potential cases of intussusception (all were in the placebo group), but all were negatively adjudicated by an independent safety monitoring board, Dr. Block said.

Children who received RotaTeq did have a statistically significant increase in temperature after the first dose, compared with placebo—13.4% of RotaTeq vaccinees, compared with 8.8% of placebo recipients. However, there was no increase in rates of fever after the second or third dose, he said. Only one child was documented to have a rotavirus vaccine strain a few days after the first dose of vaccine.

Merck is continuing a larger, 70,000-patient safety study. Preliminary results were presented at the CDC's Advisory Committee on Immunization Practices meeting in February, said Penny Heaton, director of clinical research at Merck.

So far, there have been 12 cases of intussusception in the RotaTeq group and 15 in the placebo group, she said.

WASHINGTON — Merck's experimental RotaTeq vaccine was effective against moderate and severe rotavirus at the end of its shelf life, which appears to be 18 months, lead investigator Umesh Parashar, M.D., reported at the National Immunization Conference sponsored by the Centers for Disease Control and Prevention.

A new vaccine is eagerly anticipated, because rotavirus causes 440,000 deaths and leads to 2.1 million inpatient visits in children under age 5 worldwide each year, said Dr. Parashar of the National Center for Infectious Diseases at the Centers for Disease Control and Prevention (CDC). Rotavirus causes 5% of deaths in children under age 5 worldwide. In the United States, there are few deaths—only 20-60 per year—but there are 200,000-272,000 emergency department visits and 400,000 outpatient visits because of rotavirus annually.

Stan Block, M.D., a pediatrician in private practice in Bardstown, Ky., presented the RotaTeq data on behalf of trial sites in the United States and Finland.

RotaTeq is a pentavalent oral vaccine, aiming to provide protection against the G1, G2, G3, G4, and P1 strains.

From 2002 to 2004, 1,310 healthy infants aged 6-12 weeks were assigned to receive three doses of RotaTeq (at the end of shelf life) or placebo. The doses were given 4-10 weeks apart. Children with a gastrointestinal disorder, recent surgery, or acute fever or who had taken steroids within 2 weeks of the trial were excluded. RotaTeq could be given simultaneously with other vaccines, said Dr. Block.

Children were monitored for acute gastroenteritis through one rotavirus season.

There were 69 cases of rotavirus, for an overall efficacy of 72.5%. For severe acute gastroenteritis, the vaccine was 100% effective, and for both moderate and severe gastroenteritis, it was 76.3% effective.

The vaccine also appeared to be very safe. There were five potential cases of intussusception (all were in the placebo group), but all were negatively adjudicated by an independent safety monitoring board, Dr. Block said.

Children who received RotaTeq did have a statistically significant increase in temperature after the first dose, compared with placebo—13.4% of RotaTeq vaccinees, compared with 8.8% of placebo recipients. However, there was no increase in rates of fever after the second or third dose, he said. Only one child was documented to have a rotavirus vaccine strain a few days after the first dose of vaccine.

Merck is continuing a larger, 70,000-patient safety study. Preliminary results were presented at the CDC's Advisory Committee on Immunization Practices meeting in February, said Penny Heaton, director of clinical research at Merck.

So far, there have been 12 cases of intussusception in the RotaTeq group and 15 in the placebo group, she said.

The U.S. Department of Health and Human Services recently awarded $97 million to Sanofi Pasteur to speed development of a manufacturing technique that could cut the time it takes to get an influenza vaccine to market. But the technique, which involves growing flu strains in cell culture, initially will be used only to create a vaccine against a pandemic strain.

Traditionally, vaccine production takes at least 9 months, from the time strains are selected for inclusion to when the shot is ready for distribution. The new technique might cut a few weeks off that process, with most of the savings coming in the beginning.

Under the current manufacturing scenario, influenza strains must be adapted so they can be grown in chicken eggs. Delays come when the strains either cannot be grown in eggs, or are difficult to grow. With the new technique, the strain would not need adaptation because it would be grown in a human cell line. The line—of retinal cells—was developed by a Sanofi partner, Crucell, a Dutch biotechnology company.

Even though many experts think the cell culture will be more reliable than eggs for growing influenza vaccine strains, there is no guarantee. And even if the manufacturing technique is successful, it will still have to be approved by the Food and Drug Administration.

Sanofi Pasteur said it anticipates beginning human trials late next year. The HHS contract provides funds only for phase I and II studies, but the company anticipates continuing through phase III and on to market.

As part of the HHS contract, the company is also required to complete a feasibility study for supplying up to 300 million doses a year. Currently, the company has no plans for building a manufacturing facility that could accommodate that production.

The U.S. Department of Health and Human Services recently awarded $97 million to Sanofi Pasteur to speed development of a manufacturing technique that could cut the time it takes to get an influenza vaccine to market. But the technique, which involves growing flu strains in cell culture, initially will be used only to create a vaccine against a pandemic strain.

Traditionally, vaccine production takes at least 9 months, from the time strains are selected for inclusion to when the shot is ready for distribution. The new technique might cut a few weeks off that process, with most of the savings coming in the beginning.

Under the current manufacturing scenario, influenza strains must be adapted so they can be grown in chicken eggs. Delays come when the strains either cannot be grown in eggs, or are difficult to grow. With the new technique, the strain would not need adaptation because it would be grown in a human cell line. The line—of retinal cells—was developed by a Sanofi partner, Crucell, a Dutch biotechnology company.

Even though many experts think the cell culture will be more reliable than eggs for growing influenza vaccine strains, there is no guarantee. And even if the manufacturing technique is successful, it will still have to be approved by the Food and Drug Administration.

Sanofi Pasteur said it anticipates beginning human trials late next year. The HHS contract provides funds only for phase I and II studies, but the company anticipates continuing through phase III and on to market.

As part of the HHS contract, the company is also required to complete a feasibility study for supplying up to 300 million doses a year. Currently, the company has no plans for building a manufacturing facility that could accommodate that production.

The U.S. Department of Health and Human Services recently awarded $97 million to Sanofi Pasteur to speed development of a manufacturing technique that could cut the time it takes to get an influenza vaccine to market. But the technique, which involves growing flu strains in cell culture, initially will be used only to create a vaccine against a pandemic strain.

Traditionally, vaccine production takes at least 9 months, from the time strains are selected for inclusion to when the shot is ready for distribution. The new technique might cut a few weeks off that process, with most of the savings coming in the beginning.

Under the current manufacturing scenario, influenza strains must be adapted so they can be grown in chicken eggs. Delays come when the strains either cannot be grown in eggs, or are difficult to grow. With the new technique, the strain would not need adaptation because it would be grown in a human cell line. The line—of retinal cells—was developed by a Sanofi partner, Crucell, a Dutch biotechnology company.

Even though many experts think the cell culture will be more reliable than eggs for growing influenza vaccine strains, there is no guarantee. And even if the manufacturing technique is successful, it will still have to be approved by the Food and Drug Administration.

Sanofi Pasteur said it anticipates beginning human trials late next year. The HHS contract provides funds only for phase I and II studies, but the company anticipates continuing through phase III and on to market.

As part of the HHS contract, the company is also required to complete a feasibility study for supplying up to 300 million doses a year. Currently, the company has no plans for building a manufacturing facility that could accommodate that production.

WASHINGTON — Despite the severe shortage of influenza vaccine this winter, the elderly, young children, and others at risk were able to find and receive shots, officials said at the National Immunization Conference sponsored by the Centers for Disease Control and Prevention.

Once it was known last October that Chiron Corp. would not be able to deliver its half of the nation's vaccine supply, the CDC immediately set up a special surveillance team to track where the vaccine was going and who received it, said Susan Chu, Ph.D., acting director of the agency's Office of Science Policy and Technology Transfer.

Seventeen new questions on the flu vaccine were added to the monthly Behavioral Risk Factor Surveillance System survey. From November 2004 to February 2005, 105,473 adults and 35,106 children (by proxy) were interviewed, said Michael Link, Ph.D., of the CDC's behavioral survey branch.

And, in a change of pace designed to keep state and federal agencies on top of the shortage, data were submitted to CDC weekly, not monthly, and were analyzed within days, giving states new data every 12 days or so, Dr. Link said.

As of late March, the survey found that vaccines were received by 63.5% of respondents over aged 65 years, 26% of 18- to 64-year-olds at high risk, and 36% of health care workers, said Gary Euler, Dr.P.H., of the CDC National Immunization Program's epidemiology and surveillance division. These figures were slightly higher than those gathered through January and reported in the CDC's Morbidity and Mortality Weekly Report. According to that data, 62.7% of those over aged 65 years, 25.5% of those with high-risk conditions aged 18-64 years, and 35.7% of health care workers received vaccinations (MMWR 2005;54:304-7).

Through February, among healthy Americans, 7.2% of those aged 18-49 years, and 17.3% of those 50-64 years said they had been vaccinated, compared with 6.9% and 16.5%, respectively, through January.

Fifty-two percent of children aged 6-23 months received a vaccine (up from 48.4% through January), a high uptake rate, given that 2004 was the first year the CDC's Advisory Committee on Immunization Practices recommended adding the flu shot to routine immunizations, said Carolyn Bridges, M.D., an epidemiologist with the agency's influenza branch.

Dr. Euler said there was room for improvement, as the survey found that many parents said they did not get vaccines for their children because they did not think they needed them.

The demand for vaccine among patients aged 65 years and older was mostly met, though there was some problem getting vaccine in early November, Dr. Euler said.

An audience member questioned whether some of the demand had been met in Canada. As part of the survey, patients were asked where they got a vaccine. So if they went to Canada, that data would be captured, though it has not been analyzed yet, Dr. Euler said.

Vaccination rates also varied from state to state. Preliminary data indicate that states with lower immunization coverage had a smaller vaccine supply. Further analysis of the variation and the entire flu database will be coming over the next 6 months, Dr. Link said.

The CDC researchers acknowledged that the survey was limited because it is self-reported information, and does not cover people who are institutionalized.

Dr. Bridges said the CDC currently is researching whether faster analysis of flu data helped states with their shot distribution and management.

WASHINGTON — Despite the severe shortage of influenza vaccine this winter, the elderly, young children, and others at risk were able to find and receive shots, officials said at the National Immunization Conference sponsored by the Centers for Disease Control and Prevention.

Once it was known last October that Chiron Corp. would not be able to deliver its half of the nation's vaccine supply, the CDC immediately set up a special surveillance team to track where the vaccine was going and who received it, said Susan Chu, Ph.D., acting director of the agency's Office of Science Policy and Technology Transfer.

Seventeen new questions on the flu vaccine were added to the monthly Behavioral Risk Factor Surveillance System survey. From November 2004 to February 2005, 105,473 adults and 35,106 children (by proxy) were interviewed, said Michael Link, Ph.D., of the CDC's behavioral survey branch.

And, in a change of pace designed to keep state and federal agencies on top of the shortage, data were submitted to CDC weekly, not monthly, and were analyzed within days, giving states new data every 12 days or so, Dr. Link said.

As of late March, the survey found that vaccines were received by 63.5% of respondents over aged 65 years, 26% of 18- to 64-year-olds at high risk, and 36% of health care workers, said Gary Euler, Dr.P.H., of the CDC National Immunization Program's epidemiology and surveillance division. These figures were slightly higher than those gathered through January and reported in the CDC's Morbidity and Mortality Weekly Report. According to that data, 62.7% of those over aged 65 years, 25.5% of those with high-risk conditions aged 18-64 years, and 35.7% of health care workers received vaccinations (MMWR 2005;54:304-7).

Through February, among healthy Americans, 7.2% of those aged 18-49 years, and 17.3% of those 50-64 years said they had been vaccinated, compared with 6.9% and 16.5%, respectively, through January.

Fifty-two percent of children aged 6-23 months received a vaccine (up from 48.4% through January), a high uptake rate, given that 2004 was the first year the CDC's Advisory Committee on Immunization Practices recommended adding the flu shot to routine immunizations, said Carolyn Bridges, M.D., an epidemiologist with the agency's influenza branch.

Dr. Euler said there was room for improvement, as the survey found that many parents said they did not get vaccines for their children because they did not think they needed them.

The demand for vaccine among patients aged 65 years and older was mostly met, though there was some problem getting vaccine in early November, Dr. Euler said.

An audience member questioned whether some of the demand had been met in Canada. As part of the survey, patients were asked where they got a vaccine. So if they went to Canada, that data would be captured, though it has not been analyzed yet, Dr. Euler said.

Vaccination rates also varied from state to state. Preliminary data indicate that states with lower immunization coverage had a smaller vaccine supply. Further analysis of the variation and the entire flu database will be coming over the next 6 months, Dr. Link said.

The CDC researchers acknowledged that the survey was limited because it is self-reported information, and does not cover people who are institutionalized.

Dr. Bridges said the CDC currently is researching whether faster analysis of flu data helped states with their shot distribution and management.

WASHINGTON — Despite the severe shortage of influenza vaccine this winter, the elderly, young children, and others at risk were able to find and receive shots, officials said at the National Immunization Conference sponsored by the Centers for Disease Control and Prevention.

Once it was known last October that Chiron Corp. would not be able to deliver its half of the nation's vaccine supply, the CDC immediately set up a special surveillance team to track where the vaccine was going and who received it, said Susan Chu, Ph.D., acting director of the agency's Office of Science Policy and Technology Transfer.

Seventeen new questions on the flu vaccine were added to the monthly Behavioral Risk Factor Surveillance System survey. From November 2004 to February 2005, 105,473 adults and 35,106 children (by proxy) were interviewed, said Michael Link, Ph.D., of the CDC's behavioral survey branch.

And, in a change of pace designed to keep state and federal agencies on top of the shortage, data were submitted to CDC weekly, not monthly, and were analyzed within days, giving states new data every 12 days or so, Dr. Link said.

As of late March, the survey found that vaccines were received by 63.5% of respondents over aged 65 years, 26% of 18- to 64-year-olds at high risk, and 36% of health care workers, said Gary Euler, Dr.P.H., of the CDC National Immunization Program's epidemiology and surveillance division. These figures were slightly higher than those gathered through January and reported in the CDC's Morbidity and Mortality Weekly Report. According to that data, 62.7% of those over aged 65 years, 25.5% of those with high-risk conditions aged 18-64 years, and 35.7% of health care workers received vaccinations (MMWR 2005;54:304-7).

Through February, among healthy Americans, 7.2% of those aged 18-49 years, and 17.3% of those 50-64 years said they had been vaccinated, compared with 6.9% and 16.5%, respectively, through January.

Fifty-two percent of children aged 6-23 months received a vaccine (up from 48.4% through January), a high uptake rate, given that 2004 was the first year the CDC's Advisory Committee on Immunization Practices recommended adding the flu shot to routine immunizations, said Carolyn Bridges, M.D., an epidemiologist with the agency's influenza branch.

Dr. Euler said there was room for improvement, as the survey found that many parents said they did not get vaccines for their children because they did not think they needed them.

The demand for vaccine among patients aged 65 years and older was mostly met, though there was some problem getting vaccine in early November, Dr. Euler said.

An audience member questioned whether some of the demand had been met in Canada. As part of the survey, patients were asked where they got a vaccine. So if they went to Canada, that data would be captured, though it has not been analyzed yet, Dr. Euler said.

Vaccination rates also varied from state to state. Preliminary data indicate that states with lower immunization coverage had a smaller vaccine supply. Further analysis of the variation and the entire flu database will be coming over the next 6 months, Dr. Link said.

The CDC researchers acknowledged that the survey was limited because it is self-reported information, and does not cover people who are institutionalized.

Dr. Bridges said the CDC currently is researching whether faster analysis of flu data helped states with their shot distribution and management.

WASHINGTON — Despite the severe shortage of influenza vaccine this winter, the elderly, young children, and others at risk were able to find and receive shots, officials said at the National Immunization Conference sponsored by the Centers for Disease Control and Prevention.

Once it was known last October that Chiron Corp. would not be able to deliver its half of the nation's vaccine supply, the CDC immediately set up a special surveillance team to track where the vaccine was going and who received it, said Susan Chu, Ph.D., acting director of the agency's Office of Science Policy and Technology Transfer.

Seventeen new questions on the flu vaccine were added to the monthly Behavioral Risk Factor Surveillance System survey. From November 2004 to February 2005, 105,473 adults, and 35,106 children (by proxy) were interviewed, said Michael Link, Ph.D., of the CDC's behavioral survey branch.

And, in a change of pace designed to keep state and federal agencies on top of the shortage, data were submitted to CDC weekly, not monthly, and were analyzed within days, giving states new data every 12 days or so, Dr. Link said.

As of late March, the survey found that vaccines were received by 63.5% of respondents over age 65 years, 26% of 18- to 64-year-olds at high risk, and 36% of health care workers, said Gary Euler, Dr.P.H., of the CDC National Immunization Program's epidemiology and surveillance division. These figures were slightly higher than those gathered through January and reported in the CDC's Morbidity and Mortality Weekly Report. According to those data, 62.7% of those over aged 65 years, 25.5% of those with high- risk conditions aged 18-64 years, and 35.7% of health care workers received vaccinations (MMWR 2005;54:304-7).

Through February, among healthy Americans, 7.2% of those aged 18-49 years, and 17.3% of those 50-64 years said they had been vaccinated, compared with 6.9% and 16.5%, respectively, through January.

Of children aged 6-23 months, 52% received a vaccine (up from 48.4% through January), which was a high uptake rate, given that 2004 was the first year the CDC's Advisory Committee on Immunization Practices recommended adding the flu shot to routine immunizations, said Carolyn Bridges, M.D., an epidemiologist with the agency's influenza branch.

Dr. Euler said there was room for improvement, as the survey found that many parents said they did not get vaccines for their children because they did not think their children needed them.

The demand for vaccine among patients aged 65 years and older was mostly met, though there was some problem getting vaccine in early November, Dr. Euler said.

An audience member questioned whether some of the demand had been met in Canada. As part of the survey, patients were asked where they got a vaccine. So if they went to Canada, those data would be captured, though they have not been analyzed yet, Dr. Euler said.

Vaccination rates also varied from state to state. Preliminary data indicate that states with lower immunization coverage had a smaller vaccine supply. Further analysis of the variation and the entire flu database will be coming over the next 6 months, Dr. Link said.

The CDC researchers acknowledged that the survey was limited because it is self-reported information, and does not cover people who are institutionalized.

Dr. Bridges said the CDC currently is researching whether faster analysis of flu data helped states with their shot distribution and management. And, she said, since it was an expensive undertaking, it's not clear if it will be repeated next year, or only in times of pandemic or shortages.

WASHINGTON — Despite the severe shortage of influenza vaccine this winter, the elderly, young children, and others at risk were able to find and receive shots, officials said at the National Immunization Conference sponsored by the Centers for Disease Control and Prevention.

Once it was known last October that Chiron Corp. would not be able to deliver its half of the nation's vaccine supply, the CDC immediately set up a special surveillance team to track where the vaccine was going and who received it, said Susan Chu, Ph.D., acting director of the agency's Office of Science Policy and Technology Transfer.

Seventeen new questions on the flu vaccine were added to the monthly Behavioral Risk Factor Surveillance System survey. From November 2004 to February 2005, 105,473 adults, and 35,106 children (by proxy) were interviewed, said Michael Link, Ph.D., of the CDC's behavioral survey branch.

And, in a change of pace designed to keep state and federal agencies on top of the shortage, data were submitted to CDC weekly, not monthly, and were analyzed within days, giving states new data every 12 days or so, Dr. Link said.

As of late March, the survey found that vaccines were received by 63.5% of respondents over age 65 years, 26% of 18- to 64-year-olds at high risk, and 36% of health care workers, said Gary Euler, Dr.P.H., of the CDC National Immunization Program's epidemiology and surveillance division. These figures were slightly higher than those gathered through January and reported in the CDC's Morbidity and Mortality Weekly Report. According to those data, 62.7% of those over aged 65 years, 25.5% of those with high- risk conditions aged 18-64 years, and 35.7% of health care workers received vaccinations (MMWR 2005;54:304-7).

Through February, among healthy Americans, 7.2% of those aged 18-49 years, and 17.3% of those 50-64 years said they had been vaccinated, compared with 6.9% and 16.5%, respectively, through January.

Of children aged 6-23 months, 52% received a vaccine (up from 48.4% through January), which was a high uptake rate, given that 2004 was the first year the CDC's Advisory Committee on Immunization Practices recommended adding the flu shot to routine immunizations, said Carolyn Bridges, M.D., an epidemiologist with the agency's influenza branch.

Dr. Euler said there was room for improvement, as the survey found that many parents said they did not get vaccines for their children because they did not think their children needed them.

The demand for vaccine among patients aged 65 years and older was mostly met, though there was some problem getting vaccine in early November, Dr. Euler said.

An audience member questioned whether some of the demand had been met in Canada. As part of the survey, patients were asked where they got a vaccine. So if they went to Canada, those data would be captured, though they have not been analyzed yet, Dr. Euler said.

Vaccination rates also varied from state to state. Preliminary data indicate that states with lower immunization coverage had a smaller vaccine supply. Further analysis of the variation and the entire flu database will be coming over the next 6 months, Dr. Link said.

The CDC researchers acknowledged that the survey was limited because it is self-reported information, and does not cover people who are institutionalized.

Dr. Bridges said the CDC currently is researching whether faster analysis of flu data helped states with their shot distribution and management. And, she said, since it was an expensive undertaking, it's not clear if it will be repeated next year, or only in times of pandemic or shortages.

WASHINGTON — Despite the severe shortage of influenza vaccine this winter, the elderly, young children, and others at risk were able to find and receive shots, officials said at the National Immunization Conference sponsored by the Centers for Disease Control and Prevention.

Once it was known last October that Chiron Corp. would not be able to deliver its half of the nation's vaccine supply, the CDC immediately set up a special surveillance team to track where the vaccine was going and who received it, said Susan Chu, Ph.D., acting director of the agency's Office of Science Policy and Technology Transfer.

Seventeen new questions on the flu vaccine were added to the monthly Behavioral Risk Factor Surveillance System survey. From November 2004 to February 2005, 105,473 adults, and 35,106 children (by proxy) were interviewed, said Michael Link, Ph.D., of the CDC's behavioral survey branch.

And, in a change of pace designed to keep state and federal agencies on top of the shortage, data were submitted to CDC weekly, not monthly, and were analyzed within days, giving states new data every 12 days or so, Dr. Link said.

As of late March, the survey found that vaccines were received by 63.5% of respondents over age 65 years, 26% of 18- to 64-year-olds at high risk, and 36% of health care workers, said Gary Euler, Dr.P.H., of the CDC National Immunization Program's epidemiology and surveillance division. These figures were slightly higher than those gathered through January and reported in the CDC's Morbidity and Mortality Weekly Report. According to those data, 62.7% of those over aged 65 years, 25.5% of those with high- risk conditions aged 18-64 years, and 35.7% of health care workers received vaccinations (MMWR 2005;54:304-7).

Through February, among healthy Americans, 7.2% of those aged 18-49 years, and 17.3% of those 50-64 years said they had been vaccinated, compared with 6.9% and 16.5%, respectively, through January.

Of children aged 6-23 months, 52% received a vaccine (up from 48.4% through January), which was a high uptake rate, given that 2004 was the first year the CDC's Advisory Committee on Immunization Practices recommended adding the flu shot to routine immunizations, said Carolyn Bridges, M.D., an epidemiologist with the agency's influenza branch.

Dr. Euler said there was room for improvement, as the survey found that many parents said they did not get vaccines for their children because they did not think their children needed them.

The demand for vaccine among patients aged 65 years and older was mostly met, though there was some problem getting vaccine in early November, Dr. Euler said.

An audience member questioned whether some of the demand had been met in Canada. As part of the survey, patients were asked where they got a vaccine. So if they went to Canada, those data would be captured, though they have not been analyzed yet, Dr. Euler said.

Vaccination rates also varied from state to state. Preliminary data indicate that states with lower immunization coverage had a smaller vaccine supply. Further analysis of the variation and the entire flu database will be coming over the next 6 months, Dr. Link said.

The CDC researchers acknowledged that the survey was limited because it is self-reported information, and does not cover people who are institutionalized.

Dr. Bridges said the CDC currently is researching whether faster analysis of flu data helped states with their shot distribution and management. And, she said, since it was an expensive undertaking, it's not clear if it will be repeated next year, or only in times of pandemic or shortages.

The U.S. Department of Health and Human Services recently awarded $97 million to Sanofi Pasteur to speed development of a manufacturing technique that could cut the time it takes to get an influenza vaccine to market. But the technique, which involves growing flu strains in cell culture, initially will be used only to create a vaccine against a pandemic strain.

Traditionally, vaccine production takes at least 9 months, from the time strains are selected for inclusion to when the shot is ready for distribution. The new technique might cut a few weeks off that process, with most of the savings coming in the beginning.

Under the current manufacturing scenario, influenza strains must be adapted so they can be grown in chicken eggs. Delays come when the strains either cannot be grown in eggs or are difficult to grow. With the new technique, the strain would not need adaptation because it would be grown in a human cell line. The line—of retinal cells—was developed by a Sanofi partner, Crucell, a Dutch biotechnology company.

Even though many experts think the cell culture will be more reliable than eggs for growing influenza vaccine strains, there is no guarantee. And even if the manufacturing technique is successful, it will still have to be approved by the Food and Drug Administration.

Sanofi Pasteur said it anticipates beginning human trials late next year. The HHS contract provides funds only for phase I and II studies, but the company said it anticipates continuing through phase III and on to market.

As part of the HHS contract, the company is also required to complete a feasibility study for supplying up to 300 million doses a year. Currently, the company has no plans for building a manufacturing facility that could accommodate that production, according to a spokesman.

The U.S. Department of Health and Human Services recently awarded $97 million to Sanofi Pasteur to speed development of a manufacturing technique that could cut the time it takes to get an influenza vaccine to market. But the technique, which involves growing flu strains in cell culture, initially will be used only to create a vaccine against a pandemic strain.

Traditionally, vaccine production takes at least 9 months, from the time strains are selected for inclusion to when the shot is ready for distribution. The new technique might cut a few weeks off that process, with most of the savings coming in the beginning.

Under the current manufacturing scenario, influenza strains must be adapted so they can be grown in chicken eggs. Delays come when the strains either cannot be grown in eggs or are difficult to grow. With the new technique, the strain would not need adaptation because it would be grown in a human cell line. The line—of retinal cells—was developed by a Sanofi partner, Crucell, a Dutch biotechnology company.

Even though many experts think the cell culture will be more reliable than eggs for growing influenza vaccine strains, there is no guarantee. And even if the manufacturing technique is successful, it will still have to be approved by the Food and Drug Administration.

Sanofi Pasteur said it anticipates beginning human trials late next year. The HHS contract provides funds only for phase I and II studies, but the company said it anticipates continuing through phase III and on to market.

As part of the HHS contract, the company is also required to complete a feasibility study for supplying up to 300 million doses a year. Currently, the company has no plans for building a manufacturing facility that could accommodate that production, according to a spokesman.

The U.S. Department of Health and Human Services recently awarded $97 million to Sanofi Pasteur to speed development of a manufacturing technique that could cut the time it takes to get an influenza vaccine to market. But the technique, which involves growing flu strains in cell culture, initially will be used only to create a vaccine against a pandemic strain.

Traditionally, vaccine production takes at least 9 months, from the time strains are selected for inclusion to when the shot is ready for distribution. The new technique might cut a few weeks off that process, with most of the savings coming in the beginning.

Under the current manufacturing scenario, influenza strains must be adapted so they can be grown in chicken eggs. Delays come when the strains either cannot be grown in eggs or are difficult to grow. With the new technique, the strain would not need adaptation because it would be grown in a human cell line. The line—of retinal cells—was developed by a Sanofi partner, Crucell, a Dutch biotechnology company.

Even though many experts think the cell culture will be more reliable than eggs for growing influenza vaccine strains, there is no guarantee. And even if the manufacturing technique is successful, it will still have to be approved by the Food and Drug Administration.

Sanofi Pasteur said it anticipates beginning human trials late next year. The HHS contract provides funds only for phase I and II studies, but the company said it anticipates continuing through phase III and on to market.

As part of the HHS contract, the company is also required to complete a feasibility study for supplying up to 300 million doses a year. Currently, the company has no plans for building a manufacturing facility that could accommodate that production, according to a spokesman.

Physicians frustrated with seemingly arbitrarily denied claims will have their day in court later this year with at least six insurers, thanks to a recent Supreme Court decision to deny the plans' appeal of a class action suit. But settlements related to improper denials by Cigna and Aetna are likely to provide vindication even sooner.

The legal actions affect almost every practicing physician in the United States—about 900,000 doctors.

A series of suits, originally filed by several state and county medical societies, was consolidated in a U.S. District Court in Florida in 2000 and certified as a class action in 2002. The filing named Aetna, Anthem, Cigna, Coventry, HealthNet, Humana, PacifiCare, Prudential, UnitedHealthcare, and WellPoint as defendants, and alleged that the plans violated the Racketeer Influenced and Corrupt Organizations Act (RICO) by engaging in fraud and extortion in a common scheme to wrongfully deny payment to doctors.

Aetna and Cigna broke off and entered into negotiations, an enormous process involving more than 100 attorneys, 19 state and county medical societies, the American Medical Association, and the plans' CEOs.

The two insurers settled in 2003, but the other parties have vowed to continue to fight, and are scheduled for trial in September in the Florida courtroom of Judge Federico Moreno. Another suit, with 60 Blue Cross and Blue Shield plans as defendants, is also before Judge Moreno.

Still, those other insurers could possibly follow in Aetna and Cigna's footsteps.

The Aetna claims deadline has passed, and physicians had until Feb. 18 to make a claim against Cigna, with two options for recouping losses. One was to make a general claim on Cigna's $30 million settlement pot, which will be divided equally among all who make such a claim. Or, physicians could reconstruct claims and seek repayment according to either a general amount per CPT code or a more specific amount based on a complete medical record.

Physicians who did not meet that deadline will still reap the benefits of the settlement, according to David McKenzie, reimbursement director at the American College of Emergency Physicians, who explained the various options to physicians at a recent ACEP meeting in Orlando, Fla.

Aetna agreed to set aside $300 million for prospective relief, and Cigna agreed to a $400 million figure. These amounts represent what is likely to be paid to physicians now that the two insurers have also agreed to a number of changes in business practices.

For instance, both will pay for vaccines and their administration. And the insurers will no longer automatically downcode evaluation and management codes, and will separately identify and pay modifier -25, which allows physicians to bill for evaluation and management service on the same day as a procedure. Other coding and editing changes will also lead to future income for physicians.

Both insurers agreed to disclose physician fee schedules and to change the schedules only once a year. Aetna's schedules were posted on a Web site, and Cigna agreed initially to post schedules via e-mail. Both also said they would make a preadjudication tool available so physicians could determine in advance what they might be paid for a claim.

Clean claims have to be paid within 15 days, whether submitted electronically or on paper. Aetna agreed to pay interest at the lesser rate of prime or 8%, and Cigna agreed to 6%.

Physicians frustrated with seemingly arbitrarily denied claims will have their day in court later this year with at least six insurers, thanks to a recent Supreme Court decision to deny the plans' appeal of a class action suit. But settlements related to improper denials by Cigna and Aetna are likely to provide vindication even sooner.

The legal actions affect almost every practicing physician in the United States—about 900,000 doctors.

A series of suits, originally filed by several state and county medical societies, was consolidated in a U.S. District Court in Florida in 2000 and certified as a class action in 2002. The filing named Aetna, Anthem, Cigna, Coventry, HealthNet, Humana, PacifiCare, Prudential, UnitedHealthcare, and WellPoint as defendants, and alleged that the plans violated the Racketeer Influenced and Corrupt Organizations Act (RICO) by engaging in fraud and extortion in a common scheme to wrongfully deny payment to doctors.

Aetna and Cigna broke off and entered into negotiations, an enormous process involving more than 100 attorneys, 19 state and county medical societies, the American Medical Association, and the plans' CEOs.

The two insurers settled in 2003, but the other parties have vowed to continue to fight, and are scheduled for trial in September in the Florida courtroom of Judge Federico Moreno. Another suit, with 60 Blue Cross and Blue Shield plans as defendants, is also before Judge Moreno.

Still, those other insurers could possibly follow in Aetna and Cigna's footsteps.

The Aetna claims deadline has passed, and physicians had until Feb. 18 to make a claim against Cigna, with two options for recouping losses. One was to make a general claim on Cigna's $30 million settlement pot, which will be divided equally among all who make such a claim. Or, physicians could reconstruct claims and seek repayment according to either a general amount per CPT code or a more specific amount based on a complete medical record.

Physicians who did not meet that deadline will still reap the benefits of the settlement, according to David McKenzie, reimbursement director at the American College of Emergency Physicians, who explained the various options to physicians at a recent ACEP meeting in Orlando, Fla.

Aetna agreed to set aside $300 million for prospective relief, and Cigna agreed to a $400 million figure. These amounts represent what is likely to be paid to physicians now that the two insurers have also agreed to a number of changes in business practices.

For instance, both will pay for vaccines and their administration. And the insurers will no longer automatically downcode evaluation and management codes, and will separately identify and pay modifier -25, which allows physicians to bill for evaluation and management service on the same day as a procedure. Other coding and editing changes will also lead to future income for physicians.

Both insurers agreed to disclose physician fee schedules and to change the schedules only once a year. Aetna's schedules were posted on a Web site, and Cigna agreed initially to post schedules via e-mail. Both also said they would make a preadjudication tool available so physicians could determine in advance what they might be paid for a claim.

Clean claims have to be paid within 15 days, whether submitted electronically or on paper. Aetna agreed to pay interest at the lesser rate of prime or 8%, and Cigna agreed to 6%.

Physicians frustrated with seemingly arbitrarily denied claims will have their day in court later this year with at least six insurers, thanks to a recent Supreme Court decision to deny the plans' appeal of a class action suit. But settlements related to improper denials by Cigna and Aetna are likely to provide vindication even sooner.

The legal actions affect almost every practicing physician in the United States—about 900,000 doctors.

A series of suits, originally filed by several state and county medical societies, was consolidated in a U.S. District Court in Florida in 2000 and certified as a class action in 2002. The filing named Aetna, Anthem, Cigna, Coventry, HealthNet, Humana, PacifiCare, Prudential, UnitedHealthcare, and WellPoint as defendants, and alleged that the plans violated the Racketeer Influenced and Corrupt Organizations Act (RICO) by engaging in fraud and extortion in a common scheme to wrongfully deny payment to doctors.

Aetna and Cigna broke off and entered into negotiations, an enormous process involving more than 100 attorneys, 19 state and county medical societies, the American Medical Association, and the plans' CEOs.

The two insurers settled in 2003, but the other parties have vowed to continue to fight, and are scheduled for trial in September in the Florida courtroom of Judge Federico Moreno. Another suit, with 60 Blue Cross and Blue Shield plans as defendants, is also before Judge Moreno.

Still, those other insurers could possibly follow in Aetna and Cigna's footsteps.

The Aetna claims deadline has passed, and physicians had until Feb. 18 to make a claim against Cigna, with two options for recouping losses. One was to make a general claim on Cigna's $30 million settlement pot, which will be divided equally among all who make such a claim. Or, physicians could reconstruct claims and seek repayment according to either a general amount per CPT code or a more specific amount based on a complete medical record.

Physicians who did not meet that deadline will still reap the benefits of the settlement, according to David McKenzie, reimbursement director at the American College of Emergency Physicians, who explained the various options to physicians at a recent ACEP meeting in Orlando, Fla.

Aetna agreed to set aside $300 million for prospective relief, and Cigna agreed to a $400 million figure. These amounts represent what is likely to be paid to physicians now that the two insurers have also agreed to a number of changes in business practices.

For instance, both will pay for vaccines and their administration. And the insurers will no longer automatically downcode evaluation and management codes, and will separately identify and pay modifier -25, which allows physicians to bill for evaluation and management service on the same day as a procedure. Other coding and editing changes will also lead to future income for physicians.

Both insurers agreed to disclose physician fee schedules and to change the schedules only once a year. Aetna's schedules were posted on a Web site, and Cigna agreed initially to post schedules via e-mail. Both also said they would make a preadjudication tool available so physicians could determine in advance what they might be paid for a claim.

Clean claims have to be paid within 15 days, whether submitted electronically or on paper. Aetna agreed to pay interest at the lesser rate of prime or 8%, and Cigna agreed to 6%.

Physicians frustrated with seemingly arbitrarily denied claims will have their day in court later this year with at least six insurers, thanks to a recent Supreme Court decision to deny the plans' appeal of a class action suit.

But settlements related to improper denials by Cigna and Aetna are likely to provide vindication even sooner.

The legal actions affect almost every practicing physician in the United States—approximately 900,000 doctors.

A series of suits, originally filed by several state and county medical societies, was consolidated in a U.S. District Court in Florida in 2000 and certified as a class action in 2002. The filing named Aetna, Anthem, Cigna, Coventry, HealthNet, Humana, PacifiCare, Prudential, UnitedHealthcare, and WellPoint as defendants.

The class action lawsuits alleged that the plans violated the Racketeer Influenced and Corrupt Organizations Act (RICO) by engaging in fraud and extortion in a common scheme to wrongfully deny payment to doctors.

Aetna and Cigna broke off and entered into negotiations, an enormous process involving more than 100 attorneys, 19 state and county medical societies, the American Medical Association, and the plans' CEOs.

The two insurers settled in 2003, but the other parties have vowed to continue to fight, and are scheduled for trial in September in the Florida courtroom of Judge Federico Moreno.

Another suit, with 60 Blue Cross and Blue Shield plans as defendants, is also before Judge Moreno.

Still, those other insurers could possibly follow in Aetna and Cigna's footsteps.

The Aetna claims deadline has passed, and physicians had until Feb. 18 to make a claim against Cigna, with two options for recouping losses.

One was to make a general claim on Cigna's $30 million settlement pot, which will be divided equally among all who make such a claim.

Or, physicians could reconstruct claims and seek repayment according to either a general amount per CPT code or a more specific amount based on a complete medical record.

Physicians who did not meet that deadline will still reap the benefits of the settlement, according to David McKenzie, reimbursement director at the American College of Emergency Physicians, who explained the various options to physicians at a recent ACEP meeting in Orlando, Fla.

Aetna agreed to set aside $300 million for prospective relief, and Cigna agreed to a $400 million figure. These amounts represent what is likely to be paid to physicians now that the two insurers have also agreed to a number of changes in business practices.

For instance, both Cigna and Aetna have agreed to pay for vaccines and their administration.

And the insurers will no longer automatically downcode evaluation and management codes, and will separately identify and pay modifier -25, which allows physicians to bill for evaluation and management service on the same day as a procedure. Other coding and editing changes will also lead to future income for physicians.

Both insurers agreed to disclose physician fee schedules and to change the schedules only once a year. Aetna's schedules were posted on a Web site, and Cigna agreed initially to post schedules via e-mail.

Both also said they would make a preadjudication tool available so physicians could determine in advance what they might be paid for a claim.

Clean claims have to be paid within 15 days, whether submitted electronically or on paper. Aetna agreed to pay interest at the lesser rate of prime or 8%, and Cigna agreed to 6%.

A dispute resolution process was established to ensure that Cigna and Aetna are complying with the settlement agreements—in fact, three external independent review boards are monitoring the situation.

Another result of the settlement: Cigna and Aetna agreed to endow two nonprofit foundations devoted to improving medical practice.

The year-old foundations are currently seeking grant proposals. Aetna put $20 million into the Physicians' Foundation for Health Systems Excellence, and Cigna contributed $15 million to the Physicians' Foundation for Health Systems Innovations.

For more on the foundations, go to www.physiciansfoundation.org

Physicians frustrated with seemingly arbitrarily denied claims will have their day in court later this year with at least six insurers, thanks to a recent Supreme Court decision to deny the plans' appeal of a class action suit.

But settlements related to improper denials by Cigna and Aetna are likely to provide vindication even sooner.

The legal actions affect almost every practicing physician in the United States—approximately 900,000 doctors.

A series of suits, originally filed by several state and county medical societies, was consolidated in a U.S. District Court in Florida in 2000 and certified as a class action in 2002. The filing named Aetna, Anthem, Cigna, Coventry, HealthNet, Humana, PacifiCare, Prudential, UnitedHealthcare, and WellPoint as defendants.

The class action lawsuits alleged that the plans violated the Racketeer Influenced and Corrupt Organizations Act (RICO) by engaging in fraud and extortion in a common scheme to wrongfully deny payment to doctors.

Aetna and Cigna broke off and entered into negotiations, an enormous process involving more than 100 attorneys, 19 state and county medical societies, the American Medical Association, and the plans' CEOs.

The two insurers settled in 2003, but the other parties have vowed to continue to fight, and are scheduled for trial in September in the Florida courtroom of Judge Federico Moreno.

Another suit, with 60 Blue Cross and Blue Shield plans as defendants, is also before Judge Moreno.

Still, those other insurers could possibly follow in Aetna and Cigna's footsteps.

The Aetna claims deadline has passed, and physicians had until Feb. 18 to make a claim against Cigna, with two options for recouping losses.

One was to make a general claim on Cigna's $30 million settlement pot, which will be divided equally among all who make such a claim.

Or, physicians could reconstruct claims and seek repayment according to either a general amount per CPT code or a more specific amount based on a complete medical record.

Physicians who did not meet that deadline will still reap the benefits of the settlement, according to David McKenzie, reimbursement director at the American College of Emergency Physicians, who explained the various options to physicians at a recent ACEP meeting in Orlando, Fla.

Aetna agreed to set aside $300 million for prospective relief, and Cigna agreed to a $400 million figure. These amounts represent what is likely to be paid to physicians now that the two insurers have also agreed to a number of changes in business practices.

For instance, both Cigna and Aetna have agreed to pay for vaccines and their administration.

And the insurers will no longer automatically downcode evaluation and management codes, and will separately identify and pay modifier -25, which allows physicians to bill for evaluation and management service on the same day as a procedure. Other coding and editing changes will also lead to future income for physicians.

Both insurers agreed to disclose physician fee schedules and to change the schedules only once a year. Aetna's schedules were posted on a Web site, and Cigna agreed initially to post schedules via e-mail.

Both also said they would make a preadjudication tool available so physicians could determine in advance what they might be paid for a claim.

Clean claims have to be paid within 15 days, whether submitted electronically or on paper. Aetna agreed to pay interest at the lesser rate of prime or 8%, and Cigna agreed to 6%.

A dispute resolution process was established to ensure that Cigna and Aetna are complying with the settlement agreements—in fact, three external independent review boards are monitoring the situation.

Another result of the settlement: Cigna and Aetna agreed to endow two nonprofit foundations devoted to improving medical practice.

The year-old foundations are currently seeking grant proposals. Aetna put $20 million into the Physicians' Foundation for Health Systems Excellence, and Cigna contributed $15 million to the Physicians' Foundation for Health Systems Innovations.

For more on the foundations, go to www.physiciansfoundation.org

Physicians frustrated with seemingly arbitrarily denied claims will have their day in court later this year with at least six insurers, thanks to a recent Supreme Court decision to deny the plans' appeal of a class action suit.

But settlements related to improper denials by Cigna and Aetna are likely to provide vindication even sooner.

The legal actions affect almost every practicing physician in the United States—approximately 900,000 doctors.

A series of suits, originally filed by several state and county medical societies, was consolidated in a U.S. District Court in Florida in 2000 and certified as a class action in 2002. The filing named Aetna, Anthem, Cigna, Coventry, HealthNet, Humana, PacifiCare, Prudential, UnitedHealthcare, and WellPoint as defendants.

The class action lawsuits alleged that the plans violated the Racketeer Influenced and Corrupt Organizations Act (RICO) by engaging in fraud and extortion in a common scheme to wrongfully deny payment to doctors.

Aetna and Cigna broke off and entered into negotiations, an enormous process involving more than 100 attorneys, 19 state and county medical societies, the American Medical Association, and the plans' CEOs.

The two insurers settled in 2003, but the other parties have vowed to continue to fight, and are scheduled for trial in September in the Florida courtroom of Judge Federico Moreno.

Another suit, with 60 Blue Cross and Blue Shield plans as defendants, is also before Judge Moreno.

Still, those other insurers could possibly follow in Aetna and Cigna's footsteps.

The Aetna claims deadline has passed, and physicians had until Feb. 18 to make a claim against Cigna, with two options for recouping losses.

One was to make a general claim on Cigna's $30 million settlement pot, which will be divided equally among all who make such a claim.

Or, physicians could reconstruct claims and seek repayment according to either a general amount per CPT code or a more specific amount based on a complete medical record.

Physicians who did not meet that deadline will still reap the benefits of the settlement, according to David McKenzie, reimbursement director at the American College of Emergency Physicians, who explained the various options to physicians at a recent ACEP meeting in Orlando, Fla.

Aetna agreed to set aside $300 million for prospective relief, and Cigna agreed to a $400 million figure. These amounts represent what is likely to be paid to physicians now that the two insurers have also agreed to a number of changes in business practices.

For instance, both Cigna and Aetna have agreed to pay for vaccines and their administration.

And the insurers will no longer automatically downcode evaluation and management codes, and will separately identify and pay modifier -25, which allows physicians to bill for evaluation and management service on the same day as a procedure. Other coding and editing changes will also lead to future income for physicians.

Both insurers agreed to disclose physician fee schedules and to change the schedules only once a year. Aetna's schedules were posted on a Web site, and Cigna agreed initially to post schedules via e-mail.

Both also said they would make a preadjudication tool available so physicians could determine in advance what they might be paid for a claim.

Clean claims have to be paid within 15 days, whether submitted electronically or on paper. Aetna agreed to pay interest at the lesser rate of prime or 8%, and Cigna agreed to 6%.

A dispute resolution process was established to ensure that Cigna and Aetna are complying with the settlement agreements—in fact, three external independent review boards are monitoring the situation.

Another result of the settlement: Cigna and Aetna agreed to endow two nonprofit foundations devoted to improving medical practice.

The year-old foundations are currently seeking grant proposals. Aetna put $20 million into the Physicians' Foundation for Health Systems Excellence, and Cigna contributed $15 million to the Physicians' Foundation for Health Systems Innovations.

For more on the foundations, go to www.physiciansfoundation.org

Physicians frustrated with seemingly arbitrarily denied claims will have their day in court later this year with at least six insurers, thanks to a recent Supreme Court decision to deny the plans' appeal of a class action suit. But settlements related to improper denials by Cigna and Aetna are likely to provide vindication even sooner.

The legal actions affect almost every practicing physician in the United States—about 900,000 doctors.

A series of suits, originally filed by several state and county medical societies, was consolidated in a U.S. District Court in Florida in 2000 and certified as a class action in 2002. The filing named Aetna, Anthem, Cigna, Coventry, HealthNet, Humana, PacifiCare, Prudential, UnitedHealthcare, and WellPoint as defendants, and alleged that the plans violated the Racketeer Influenced and Corrupt Organizations Act (RICO) by engaging in fraud and extortion in a common scheme to wrongfully deny payment to doctors.

Aetna and Cigna broke off and entered into negotiations, an enormous process involving more than 100 attorneys, 19 state and county medical societies, the American Medical Association, and the plans' CEOs.

The two insurers settled in 2003, but the other parties have vowed to continue to fight, and are scheduled for trial in September in the Florida courtroom of Judge Federico Moreno. Another suit, with 60 Blue Cross and Blue Shield plans as defendants, is also before Judge Moreno.

Still, the other insurers may follow in Aetna and Cigna's lead.

The Aetna claims deadline has passed, and physicians had until Feb. 18 to make a claim against Cigna, with two options for recouping losses. One was to make a general claim on Cigna's $30 million settlement pot, which will be divided equally among all who make such a claim. Or, physicians could reconstruct claims and seek repayment according to either a general amount per CPT code or a more specific amount based on a complete medical record.

Physicians who did not meet that deadline will still reap the benefits of the settlement, according to David McKenzie, reimbursement director at the American College of Emergency Physicians, who explained the various options to physicians at a recent ACEP meeting in Orlando, Fla.

Aetna agreed to set aside $300 million for prospective relief, and Cigna agreed to a $400 million figure. These amounts represent what is likely to be paid to physicians now that the two insurers have also agreed to a number of changes in business practices.

For instance, both will pay for vaccines and their administration. And the insurers will no longer automatically downcode evaluation and management codes, and will separately identify and pay modifier -25, which allows physicians to bill for evaluation and management service on the same day as a procedure. Other coding and editing changes will also lead to future income for physicians.

Both insurers agreed to disclose physician fee schedules and to change the schedules only once a year. Aetna's schedules were posted on a Web site, and Cigna agreed initially to post schedules via e-mail. Both also said they would make a preadjudication tool available so physicians could determine in advance what they might be paid for a claim.

Clean claims have to be paid within 15 days. Aetna agreed to pay interest at the lesser rate of prime or 8%, and Cigna agreed to 6%.

A dispute resolution process was established to ensure that Cigna and Aetna are complying with the settlement agreements—in fact, three external independent review boards are monitoring the situation.

In the settlement Cigna and Aetna agreed to endow two nonprofit foundations devoted to improving medical practice. For more on the foundations, go to www.physiciansfoundation.org

Physicians frustrated with seemingly arbitrarily denied claims will have their day in court later this year with at least six insurers, thanks to a recent Supreme Court decision to deny the plans' appeal of a class action suit. But settlements related to improper denials by Cigna and Aetna are likely to provide vindication even sooner.

The legal actions affect almost every practicing physician in the United States—about 900,000 doctors.

A series of suits, originally filed by several state and county medical societies, was consolidated in a U.S. District Court in Florida in 2000 and certified as a class action in 2002. The filing named Aetna, Anthem, Cigna, Coventry, HealthNet, Humana, PacifiCare, Prudential, UnitedHealthcare, and WellPoint as defendants, and alleged that the plans violated the Racketeer Influenced and Corrupt Organizations Act (RICO) by engaging in fraud and extortion in a common scheme to wrongfully deny payment to doctors.

Aetna and Cigna broke off and entered into negotiations, an enormous process involving more than 100 attorneys, 19 state and county medical societies, the American Medical Association, and the plans' CEOs.

The two insurers settled in 2003, but the other parties have vowed to continue to fight, and are scheduled for trial in September in the Florida courtroom of Judge Federico Moreno. Another suit, with 60 Blue Cross and Blue Shield plans as defendants, is also before Judge Moreno.

Still, the other insurers may follow in Aetna and Cigna's lead.

The Aetna claims deadline has passed, and physicians had until Feb. 18 to make a claim against Cigna, with two options for recouping losses. One was to make a general claim on Cigna's $30 million settlement pot, which will be divided equally among all who make such a claim. Or, physicians could reconstruct claims and seek repayment according to either a general amount per CPT code or a more specific amount based on a complete medical record.

Physicians who did not meet that deadline will still reap the benefits of the settlement, according to David McKenzie, reimbursement director at the American College of Emergency Physicians, who explained the various options to physicians at a recent ACEP meeting in Orlando, Fla.

Aetna agreed to set aside $300 million for prospective relief, and Cigna agreed to a $400 million figure. These amounts represent what is likely to be paid to physicians now that the two insurers have also agreed to a number of changes in business practices.

For instance, both will pay for vaccines and their administration. And the insurers will no longer automatically downcode evaluation and management codes, and will separately identify and pay modifier -25, which allows physicians to bill for evaluation and management service on the same day as a procedure. Other coding and editing changes will also lead to future income for physicians.

Both insurers agreed to disclose physician fee schedules and to change the schedules only once a year. Aetna's schedules were posted on a Web site, and Cigna agreed initially to post schedules via e-mail. Both also said they would make a preadjudication tool available so physicians could determine in advance what they might be paid for a claim.

Clean claims have to be paid within 15 days. Aetna agreed to pay interest at the lesser rate of prime or 8%, and Cigna agreed to 6%.

A dispute resolution process was established to ensure that Cigna and Aetna are complying with the settlement agreements—in fact, three external independent review boards are monitoring the situation.

In the settlement Cigna and Aetna agreed to endow two nonprofit foundations devoted to improving medical practice. For more on the foundations, go to www.physiciansfoundation.org

Physicians frustrated with seemingly arbitrarily denied claims will have their day in court later this year with at least six insurers, thanks to a recent Supreme Court decision to deny the plans' appeal of a class action suit. But settlements related to improper denials by Cigna and Aetna are likely to provide vindication even sooner.

The legal actions affect almost every practicing physician in the United States—about 900,000 doctors.

A series of suits, originally filed by several state and county medical societies, was consolidated in a U.S. District Court in Florida in 2000 and certified as a class action in 2002. The filing named Aetna, Anthem, Cigna, Coventry, HealthNet, Humana, PacifiCare, Prudential, UnitedHealthcare, and WellPoint as defendants, and alleged that the plans violated the Racketeer Influenced and Corrupt Organizations Act (RICO) by engaging in fraud and extortion in a common scheme to wrongfully deny payment to doctors.

Aetna and Cigna broke off and entered into negotiations, an enormous process involving more than 100 attorneys, 19 state and county medical societies, the American Medical Association, and the plans' CEOs.

The two insurers settled in 2003, but the other parties have vowed to continue to fight, and are scheduled for trial in September in the Florida courtroom of Judge Federico Moreno. Another suit, with 60 Blue Cross and Blue Shield plans as defendants, is also before Judge Moreno.

Still, the other insurers may follow in Aetna and Cigna's lead.

The Aetna claims deadline has passed, and physicians had until Feb. 18 to make a claim against Cigna, with two options for recouping losses. One was to make a general claim on Cigna's $30 million settlement pot, which will be divided equally among all who make such a claim. Or, physicians could reconstruct claims and seek repayment according to either a general amount per CPT code or a more specific amount based on a complete medical record.

Physicians who did not meet that deadline will still reap the benefits of the settlement, according to David McKenzie, reimbursement director at the American College of Emergency Physicians, who explained the various options to physicians at a recent ACEP meeting in Orlando, Fla.

Aetna agreed to set aside $300 million for prospective relief, and Cigna agreed to a $400 million figure. These amounts represent what is likely to be paid to physicians now that the two insurers have also agreed to a number of changes in business practices.

For instance, both will pay for vaccines and their administration. And the insurers will no longer automatically downcode evaluation and management codes, and will separately identify and pay modifier -25, which allows physicians to bill for evaluation and management service on the same day as a procedure. Other coding and editing changes will also lead to future income for physicians.

Both insurers agreed to disclose physician fee schedules and to change the schedules only once a year. Aetna's schedules were posted on a Web site, and Cigna agreed initially to post schedules via e-mail. Both also said they would make a preadjudication tool available so physicians could determine in advance what they might be paid for a claim.

Clean claims have to be paid within 15 days. Aetna agreed to pay interest at the lesser rate of prime or 8%, and Cigna agreed to 6%.

A dispute resolution process was established to ensure that Cigna and Aetna are complying with the settlement agreements—in fact, three external independent review boards are monitoring the situation.

In the settlement Cigna and Aetna agreed to endow two nonprofit foundations devoted to improving medical practice. For more on the foundations, go to www.physiciansfoundation.org

WASHINGTON — Local anesthetic injected into the lumbar spine, either alone or with a steroid, may help patients avoid surgery for as long as 5 years, according to a study presented by K. Daniel Riew, M.D., and colleagues at the annual meeting of the American Academy of Orthopaedic Surgeons.

The study was a follow-up of a trial they published in the Journal of Bone and Joint Surgery in 2000, in which 55 patients who were surgical candidates were randomly assigned instead to a selective nerve root injection of either bupivacaine alone or bupivacaine and betamethasone. Neither the physician nor the patient knew which was being injected. The injections were administered under fluoroscopic guidance.

At that time, 29 of the 55 patients avoided surgery. Dr. Riew and his colleagues contacted these patients 5 years post injection, and 21 responded. Of those, 9 patients had been injected with only the local anesthetic; and of those patients, 8 had avoided surgery during the intervening years. Twelve of the 21 had been injected with the anesthetic plus steroid, and 9 of those 12 had avoided surgery in the intervening years.

There was no significant difference in surgery avoidance between the patients who had the local anesthetic alone and those receiving the bupivacaine with betamethasone. Dr. Riew said the bupivacaine alone may have had a placebo effect. But, he added, the original nerve root irritation could have healed on its own.

Among the 21 responding patients, 14 had spinal stenosis and 7 had a herniated disc as the initial diagnosis. There was no difference in outcomes between these two groups. All the patients had significant decreases in neurologic symptoms and back pain at 5-year follow-up, said Dr. Riew of Washington University, St Louis.

WASHINGTON — Local anesthetic injected into the lumbar spine, either alone or with a steroid, may help patients avoid surgery for as long as 5 years, according to a study presented by K. Daniel Riew, M.D., and colleagues at the annual meeting of the American Academy of Orthopaedic Surgeons.

The study was a follow-up of a trial they published in the Journal of Bone and Joint Surgery in 2000, in which 55 patients who were surgical candidates were randomly assigned instead to a selective nerve root injection of either bupivacaine alone or bupivacaine and betamethasone. Neither the physician nor the patient knew which was being injected. The injections were administered under fluoroscopic guidance.

At that time, 29 of the 55 patients avoided surgery. Dr. Riew and his colleagues contacted these patients 5 years post injection, and 21 responded. Of those, 9 patients had been injected with only the local anesthetic; and of those patients, 8 had avoided surgery during the intervening years. Twelve of the 21 had been injected with the anesthetic plus steroid, and 9 of those 12 had avoided surgery in the intervening years.

There was no significant difference in surgery avoidance between the patients who had the local anesthetic alone and those receiving the bupivacaine with betamethasone. Dr. Riew said the bupivacaine alone may have had a placebo effect. But, he added, the original nerve root irritation could have healed on its own.

Among the 21 responding patients, 14 had spinal stenosis and 7 had a herniated disc as the initial diagnosis. There was no difference in outcomes between these two groups. All the patients had significant decreases in neurologic symptoms and back pain at 5-year follow-up, said Dr. Riew of Washington University, St Louis.

WASHINGTON — Local anesthetic injected into the lumbar spine, either alone or with a steroid, may help patients avoid surgery for as long as 5 years, according to a study presented by K. Daniel Riew, M.D., and colleagues at the annual meeting of the American Academy of Orthopaedic Surgeons.

The study was a follow-up of a trial they published in the Journal of Bone and Joint Surgery in 2000, in which 55 patients who were surgical candidates were randomly assigned instead to a selective nerve root injection of either bupivacaine alone or bupivacaine and betamethasone. Neither the physician nor the patient knew which was being injected. The injections were administered under fluoroscopic guidance.

At that time, 29 of the 55 patients avoided surgery. Dr. Riew and his colleagues contacted these patients 5 years post injection, and 21 responded. Of those, 9 patients had been injected with only the local anesthetic; and of those patients, 8 had avoided surgery during the intervening years. Twelve of the 21 had been injected with the anesthetic plus steroid, and 9 of those 12 had avoided surgery in the intervening years.

There was no significant difference in surgery avoidance between the patients who had the local anesthetic alone and those receiving the bupivacaine with betamethasone. Dr. Riew said the bupivacaine alone may have had a placebo effect. But, he added, the original nerve root irritation could have healed on its own.

Among the 21 responding patients, 14 had spinal stenosis and 7 had a herniated disc as the initial diagnosis. There was no difference in outcomes between these two groups. All the patients had significant decreases in neurologic symptoms and back pain at 5-year follow-up, said Dr. Riew of Washington University, St Louis.

WASHINGTON — Patients who undergo anterior cruciate ligament reconstruction may be at increased risk of developing clinical osteoarthritis, according to results from a 10-year follow-up study of 90 patients.

Interestingly, many patients reported not being aware of their condition, and nearly half noted that it had not affected their activity level, according to Justin Roe, M.D., who presented the findings at the annual meeting of the American Academy of Orthopaedic Surgeons.

Patients initially underwent endoscopic anterior cruciate ligament (ACL) reconstruction with patellar tendon autograft and interference screw fixation. The mean age was 25 years, and the patients were evaluated annually for 5 years, and again at 7 and 10 years after surgery, said Dr. Roe of the North Sydney Orthopaedic Sports Medicine Centre, Australia.

Outcomes were measured using the International Knee Documentation Committee (IKDC) Standard Evaluation and Lysholm knee scoring. Radiographs were taken at 2, 5, 7, and 10 years after surgery.

Five-year data were previously published. At 10 years, 84 patients still had intact grafts (six had ruptures); of these, 75 were evaluated. In that group, 18 patients had a contralateral rupture and 8 had surgery for meniscal or chondral symptoms.

Based on scores and radiographs, 48% had mild to moderate evidence of osteoarthritis, said Dr. Roe. At 2 years, 33% had an increase in pain when kneeling; by 10 years, 58% said they felt increased pain. A quarter of the patients had a loss of range of extension, compared with the contralateral knee, but it was less than five degrees in 20% of that group.

On laxity testing, 97% had a grade of 0-1 on Lachman and pivot shift testing, and 81% had less than 3 mm of tibial displacement.

Despite the clinical findings, 96% of patients said they felt their knee function was normal, and about half were still taking part in moderate to strenuous activity. The patients who were not as active said it was because of other lifestyle issues, Dr. Roe said.

Predictors of abnormal knee radiographs included increased age at surgery, increased laxity at 2 years and swelling with activity at 10 years, he said.

It is not clear why osteoarthritis is appearing in these knees. There is an injury to the entire knee with an ACL rupture. It's probable that the injury—and not the subsequent surgery—contributed most to the development of arthritis, he surmised.

WASHINGTON — Patients who undergo anterior cruciate ligament reconstruction may be at increased risk of developing clinical osteoarthritis, according to results from a 10-year follow-up study of 90 patients.

Interestingly, many patients reported not being aware of their condition, and nearly half noted that it had not affected their activity level, according to Justin Roe, M.D., who presented the findings at the annual meeting of the American Academy of Orthopaedic Surgeons.

Patients initially underwent endoscopic anterior cruciate ligament (ACL) reconstruction with patellar tendon autograft and interference screw fixation. The mean age was 25 years, and the patients were evaluated annually for 5 years, and again at 7 and 10 years after surgery, said Dr. Roe of the North Sydney Orthopaedic Sports Medicine Centre, Australia.

Outcomes were measured using the International Knee Documentation Committee (IKDC) Standard Evaluation and Lysholm knee scoring. Radiographs were taken at 2, 5, 7, and 10 years after surgery.

Five-year data were previously published. At 10 years, 84 patients still had intact grafts (six had ruptures); of these, 75 were evaluated. In that group, 18 patients had a contralateral rupture and 8 had surgery for meniscal or chondral symptoms.

Based on scores and radiographs, 48% had mild to moderate evidence of osteoarthritis, said Dr. Roe. At 2 years, 33% had an increase in pain when kneeling; by 10 years, 58% said they felt increased pain. A quarter of the patients had a loss of range of extension, compared with the contralateral knee, but it was less than five degrees in 20% of that group.

On laxity testing, 97% had a grade of 0-1 on Lachman and pivot shift testing, and 81% had less than 3 mm of tibial displacement.

Despite the clinical findings, 96% of patients said they felt their knee function was normal, and about half were still taking part in moderate to strenuous activity. The patients who were not as active said it was because of other lifestyle issues, Dr. Roe said.

Predictors of abnormal knee radiographs included increased age at surgery, increased laxity at 2 years and swelling with activity at 10 years, he said.

It is not clear why osteoarthritis is appearing in these knees. There is an injury to the entire knee with an ACL rupture. It's probable that the injury—and not the subsequent surgery—contributed most to the development of arthritis, he surmised.

WASHINGTON — Patients who undergo anterior cruciate ligament reconstruction may be at increased risk of developing clinical osteoarthritis, according to results from a 10-year follow-up study of 90 patients.

Interestingly, many patients reported not being aware of their condition, and nearly half noted that it had not affected their activity level, according to Justin Roe, M.D., who presented the findings at the annual meeting of the American Academy of Orthopaedic Surgeons.

Patients initially underwent endoscopic anterior cruciate ligament (ACL) reconstruction with patellar tendon autograft and interference screw fixation. The mean age was 25 years, and the patients were evaluated annually for 5 years, and again at 7 and 10 years after surgery, said Dr. Roe of the North Sydney Orthopaedic Sports Medicine Centre, Australia.

Outcomes were measured using the International Knee Documentation Committee (IKDC) Standard Evaluation and Lysholm knee scoring. Radiographs were taken at 2, 5, 7, and 10 years after surgery.

Five-year data were previously published. At 10 years, 84 patients still had intact grafts (six had ruptures); of these, 75 were evaluated. In that group, 18 patients had a contralateral rupture and 8 had surgery for meniscal or chondral symptoms.

Based on scores and radiographs, 48% had mild to moderate evidence of osteoarthritis, said Dr. Roe. At 2 years, 33% had an increase in pain when kneeling; by 10 years, 58% said they felt increased pain. A quarter of the patients had a loss of range of extension, compared with the contralateral knee, but it was less than five degrees in 20% of that group.

On laxity testing, 97% had a grade of 0-1 on Lachman and pivot shift testing, and 81% had less than 3 mm of tibial displacement.

Despite the clinical findings, 96% of patients said they felt their knee function was normal, and about half were still taking part in moderate to strenuous activity. The patients who were not as active said it was because of other lifestyle issues, Dr. Roe said.

Predictors of abnormal knee radiographs included increased age at surgery, increased laxity at 2 years and swelling with activity at 10 years, he said.

It is not clear why osteoarthritis is appearing in these knees. There is an injury to the entire knee with an ACL rupture. It's probable that the injury—and not the subsequent surgery—contributed most to the development of arthritis, he surmised.