Alicia Ault

Just under 27,000 Americans chose – but did not necessarily pay for – health insurance through the federal healthcare.gov website during its first month of operation.

The Department of Health and Human Services reports that from Oct. 1 to Nov. 2, a total of 106,185 people – 26,794 via healthcare.gov and 79,391 via state-based health insurance exchanges – had selected a plan for enrollment. Hundreds of thousands more (396,261) had been determined to be eligible for Medicaid or the Children’s Health Insurance Plan (CHIP). The majority of those (212,865) went through one of the 15 state-based exchanges, while 183,396 got the determination through healthcare.gov, which serves as the health insurance exchange for 36 states.

HHS Secretary Kathleen Sebelius said in a briefing with reporters that the Administration at present could not release the number of people who have paid for insurance. Those data will be available by Dec. 15, which is the deadline for getting coverage that starts Jan. 1.

But the numbers indicate that the "marketplace is working" and that people are enrolling in person, over the phone, and online, Ms. Sebelius said. She added that the data show that people have not bought plans yet are still shopping.

"People want to make sure their doctors are in their network, they want to see what kind of benefits they have, they want to check out options, they want to talk to people," she said. The expectation is that "these numbers will grow substantially over next 5 months."

Physicians may not be aware of whether they are participating in an exchange plan or they may not be participating. A recent survey by the Medical Society of the State of New York found that a third of members weren’t sure if they were in an exchange plan network and another third said they would not participate in an exchange plan.

In an interview, Dr. Stephen L. Brotherton, president of the Texas Medical Association, said that "the street information is different" from what the Centers for Medicare & Medicaid Services is reporting on what consumers can learn about physician networks.

Meanwhile, Ms. Sebelius said that interest in purchasing health insurance is "reflected in the numbers of people who are seeking information and shopping for plans."

According to the HHS report, there have been about 27 million unique visitors to healthcare.gov and 3.1 million calls to state and federal call centers.

In the first month, 846,184 applications, representing just over 1.5 million Americans, were completed through the state and federal online sites. HHS says that this figure represents about 22% of the estimated 7 million people the Congressional Budget Office said were likely to enroll in a plan in 2014. About a half million people who submitted applications were not eligible for a health insurance exchange plan. Out of the 1 million who have been determined to be eligible, about 106,000 have selected a plan through the federal or state exchanges.

HHS says there were an additional 259,107 paper and phone applications for plans through the federal exchange.

The HHS report found that shopping online was the primary mode for most exchange users. On average, 93% of state exchange applications that were submitted and completed were done electronically. That dropped to 67% for applications submitted and completed through healthcare.gov.

On Nov. 12, CMS officials said that the agency would be sending "waves" of e-mails to some 275,000 people who had tried to get on healthcare.gov in the early weeks and had not succeeded. They also said that the site was currently configured to handle any added demand from people responding to those e-mails.

Ms. Sebelius said that she remains optimistic that enrollment figures will grow. "Will we convert 100%? Probably not, but I don’t think that was ever the expectation," she said.

"But I think a number of the people who are currently in the shopping mode will at the end of the day enroll in coverage."

[email protected]

On Twitter @aliciaault

Just under 27,000 Americans chose – but did not necessarily pay for – health insurance through the federal healthcare.gov website during its first month of operation.

The Department of Health and Human Services reports that from Oct. 1 to Nov. 2, a total of 106,185 people – 26,794 via healthcare.gov and 79,391 via state-based health insurance exchanges – had selected a plan for enrollment. Hundreds of thousands more (396,261) had been determined to be eligible for Medicaid or the Children’s Health Insurance Plan (CHIP). The majority of those (212,865) went through one of the 15 state-based exchanges, while 183,396 got the determination through healthcare.gov, which serves as the health insurance exchange for 36 states.

HHS Secretary Kathleen Sebelius said in a briefing with reporters that the Administration at present could not release the number of people who have paid for insurance. Those data will be available by Dec. 15, which is the deadline for getting coverage that starts Jan. 1.

But the numbers indicate that the "marketplace is working" and that people are enrolling in person, over the phone, and online, Ms. Sebelius said. She added that the data show that people have not bought plans yet are still shopping.

"People want to make sure their doctors are in their network, they want to see what kind of benefits they have, they want to check out options, they want to talk to people," she said. The expectation is that "these numbers will grow substantially over next 5 months."

Physicians may not be aware of whether they are participating in an exchange plan or they may not be participating. A recent survey by the Medical Society of the State of New York found that a third of members weren’t sure if they were in an exchange plan network and another third said they would not participate in an exchange plan.

In an interview, Dr. Stephen L. Brotherton, president of the Texas Medical Association, said that "the street information is different" from what the Centers for Medicare & Medicaid Services is reporting on what consumers can learn about physician networks.

Meanwhile, Ms. Sebelius said that interest in purchasing health insurance is "reflected in the numbers of people who are seeking information and shopping for plans."

According to the HHS report, there have been about 27 million unique visitors to healthcare.gov and 3.1 million calls to state and federal call centers.

In the first month, 846,184 applications, representing just over 1.5 million Americans, were completed through the state and federal online sites. HHS says that this figure represents about 22% of the estimated 7 million people the Congressional Budget Office said were likely to enroll in a plan in 2014. About a half million people who submitted applications were not eligible for a health insurance exchange plan. Out of the 1 million who have been determined to be eligible, about 106,000 have selected a plan through the federal or state exchanges.

HHS says there were an additional 259,107 paper and phone applications for plans through the federal exchange.

The HHS report found that shopping online was the primary mode for most exchange users. On average, 93% of state exchange applications that were submitted and completed were done electronically. That dropped to 67% for applications submitted and completed through healthcare.gov.

On Nov. 12, CMS officials said that the agency would be sending "waves" of e-mails to some 275,000 people who had tried to get on healthcare.gov in the early weeks and had not succeeded. They also said that the site was currently configured to handle any added demand from people responding to those e-mails.

Ms. Sebelius said that she remains optimistic that enrollment figures will grow. "Will we convert 100%? Probably not, but I don’t think that was ever the expectation," she said.

"But I think a number of the people who are currently in the shopping mode will at the end of the day enroll in coverage."

[email protected]

On Twitter @aliciaault

Just under 27,000 Americans chose – but did not necessarily pay for – health insurance through the federal healthcare.gov website during its first month of operation.

The Department of Health and Human Services reports that from Oct. 1 to Nov. 2, a total of 106,185 people – 26,794 via healthcare.gov and 79,391 via state-based health insurance exchanges – had selected a plan for enrollment. Hundreds of thousands more (396,261) had been determined to be eligible for Medicaid or the Children’s Health Insurance Plan (CHIP). The majority of those (212,865) went through one of the 15 state-based exchanges, while 183,396 got the determination through healthcare.gov, which serves as the health insurance exchange for 36 states.

HHS Secretary Kathleen Sebelius said in a briefing with reporters that the Administration at present could not release the number of people who have paid for insurance. Those data will be available by Dec. 15, which is the deadline for getting coverage that starts Jan. 1.

But the numbers indicate that the "marketplace is working" and that people are enrolling in person, over the phone, and online, Ms. Sebelius said. She added that the data show that people have not bought plans yet are still shopping.

"People want to make sure their doctors are in their network, they want to see what kind of benefits they have, they want to check out options, they want to talk to people," she said. The expectation is that "these numbers will grow substantially over next 5 months."

Physicians may not be aware of whether they are participating in an exchange plan or they may not be participating. A recent survey by the Medical Society of the State of New York found that a third of members weren’t sure if they were in an exchange plan network and another third said they would not participate in an exchange plan.

In an interview, Dr. Stephen L. Brotherton, president of the Texas Medical Association, said that "the street information is different" from what the Centers for Medicare & Medicaid Services is reporting on what consumers can learn about physician networks.

Meanwhile, Ms. Sebelius said that interest in purchasing health insurance is "reflected in the numbers of people who are seeking information and shopping for plans."

According to the HHS report, there have been about 27 million unique visitors to healthcare.gov and 3.1 million calls to state and federal call centers.

In the first month, 846,184 applications, representing just over 1.5 million Americans, were completed through the state and federal online sites. HHS says that this figure represents about 22% of the estimated 7 million people the Congressional Budget Office said were likely to enroll in a plan in 2014. About a half million people who submitted applications were not eligible for a health insurance exchange plan. Out of the 1 million who have been determined to be eligible, about 106,000 have selected a plan through the federal or state exchanges.

HHS says there were an additional 259,107 paper and phone applications for plans through the federal exchange.

The HHS report found that shopping online was the primary mode for most exchange users. On average, 93% of state exchange applications that were submitted and completed were done electronically. That dropped to 67% for applications submitted and completed through healthcare.gov.

On Nov. 12, CMS officials said that the agency would be sending "waves" of e-mails to some 275,000 people who had tried to get on healthcare.gov in the early weeks and had not succeeded. They also said that the site was currently configured to handle any added demand from people responding to those e-mails.

Ms. Sebelius said that she remains optimistic that enrollment figures will grow. "Will we convert 100%? Probably not, but I don’t think that was ever the expectation," she said.

"But I think a number of the people who are currently in the shopping mode will at the end of the day enroll in coverage."

[email protected]

On Twitter @aliciaault

WASHINGTON – The nation’s health bill is slated to continue to grow slowly through the end of this year, but that trend is not attributable to the Affordable Care Act. By 2022, the ACA is expected to cut the number of uninsured by 30 million, but also add about 0.1% to the nation’s health tab each year, adding up to an additional $621 billion over the next decade, according to an annual estimate of trends in health spending by analysts from the Centers for Medicare and Medicaid Services in Health Affairs (doi:10.1377/hlthaff.2013.0721).

In 2012 spending overall grew only 3.9%, to $2.8 trillion. Spending is likely to stay under 4% in 2013, in line with the historically low rate of growth seen over the past few years.

The decrease in health spending cannot be attributed to the Affordable Care Act, which became law in 2010, they said.

"In our projections, we have incorporated some modest savings regarding delivery system reforms; however, at this time it’s a little too early to tell how substantial those savings will be in the longer term," Gigi Cuckler, an economist in the CMS Office of the Actuary, told reporters.

The most recent downturn in spending is driven by bigger trends. What has been seen over the past 50 years is that when the economy shrinks, so does health spending, said Ms. Cuckler. When the economy recovers, health care spending grows.

"Until we see evidence that relationship has been broken, it’s very difficult for us to conclude that something structural has occurred," said Stephen Heffler, also of the Office of the Actuary at the CMS.

Medicare spending grew by 4.6% in 2012, down from 6.2% growth in 2011. Factors included lower spending on skilled nursing facilities; lower spending on prescriptions drugs such as Plavix (clopidogrel), which went off-patent; and lower payments to some providers mandated by the ACA.

This year, Medicare spending will grow even more slowly, in part from a continued slowdown in spending on hospitals and physicians. The automatic 2% spending from sequestration will also play a role.

Medicaid spending grew just over 2% in 2012, in part because the federal government reduced its matching rate and states employed cost-containment efforts. Medicaid is expected to grow by almost 5% in 2013, partly because primary care physicians were being paid at the higher rate.

In 2014, when millions are expected to gain coverage through the ACA, health spending is expected to grow by 6% – almost 2% faster than expected if the law were not in effect. The main spending drivers in 2014 will be growth in Medicaid and growth in private health insurance.

There is a projected 7% increase in spending on physician services in 2014 – compared to just under 5% in 2012 and around 4% in 2013. That 7% figure would drop to a little under 5% if Congress allows the scheduled 25% cut in physician payments – mandated by the SGR – in January.

[email protected]

WASHINGTON – The nation’s health bill is slated to continue to grow slowly through the end of this year, but that trend is not attributable to the Affordable Care Act. By 2022, the ACA is expected to cut the number of uninsured by 30 million, but also add about 0.1% to the nation’s health tab each year, adding up to an additional $621 billion over the next decade, according to an annual estimate of trends in health spending by analysts from the Centers for Medicare and Medicaid Services in Health Affairs (doi:10.1377/hlthaff.2013.0721).

In 2012 spending overall grew only 3.9%, to $2.8 trillion. Spending is likely to stay under 4% in 2013, in line with the historically low rate of growth seen over the past few years.

The decrease in health spending cannot be attributed to the Affordable Care Act, which became law in 2010, they said.

"In our projections, we have incorporated some modest savings regarding delivery system reforms; however, at this time it’s a little too early to tell how substantial those savings will be in the longer term," Gigi Cuckler, an economist in the CMS Office of the Actuary, told reporters.

The most recent downturn in spending is driven by bigger trends. What has been seen over the past 50 years is that when the economy shrinks, so does health spending, said Ms. Cuckler. When the economy recovers, health care spending grows.

"Until we see evidence that relationship has been broken, it’s very difficult for us to conclude that something structural has occurred," said Stephen Heffler, also of the Office of the Actuary at the CMS.

Medicare spending grew by 4.6% in 2012, down from 6.2% growth in 2011. Factors included lower spending on skilled nursing facilities; lower spending on prescriptions drugs such as Plavix (clopidogrel), which went off-patent; and lower payments to some providers mandated by the ACA.

This year, Medicare spending will grow even more slowly, in part from a continued slowdown in spending on hospitals and physicians. The automatic 2% spending from sequestration will also play a role.

Medicaid spending grew just over 2% in 2012, in part because the federal government reduced its matching rate and states employed cost-containment efforts. Medicaid is expected to grow by almost 5% in 2013, partly because primary care physicians were being paid at the higher rate.

In 2014, when millions are expected to gain coverage through the ACA, health spending is expected to grow by 6% – almost 2% faster than expected if the law were not in effect. The main spending drivers in 2014 will be growth in Medicaid and growth in private health insurance.

There is a projected 7% increase in spending on physician services in 2014 – compared to just under 5% in 2012 and around 4% in 2013. That 7% figure would drop to a little under 5% if Congress allows the scheduled 25% cut in physician payments – mandated by the SGR – in January.

[email protected]

WASHINGTON – The nation’s health bill is slated to continue to grow slowly through the end of this year, but that trend is not attributable to the Affordable Care Act. By 2022, the ACA is expected to cut the number of uninsured by 30 million, but also add about 0.1% to the nation’s health tab each year, adding up to an additional $621 billion over the next decade, according to an annual estimate of trends in health spending by analysts from the Centers for Medicare and Medicaid Services in Health Affairs (doi:10.1377/hlthaff.2013.0721).

In 2012 spending overall grew only 3.9%, to $2.8 trillion. Spending is likely to stay under 4% in 2013, in line with the historically low rate of growth seen over the past few years.

The decrease in health spending cannot be attributed to the Affordable Care Act, which became law in 2010, they said.

"In our projections, we have incorporated some modest savings regarding delivery system reforms; however, at this time it’s a little too early to tell how substantial those savings will be in the longer term," Gigi Cuckler, an economist in the CMS Office of the Actuary, told reporters.

The most recent downturn in spending is driven by bigger trends. What has been seen over the past 50 years is that when the economy shrinks, so does health spending, said Ms. Cuckler. When the economy recovers, health care spending grows.

"Until we see evidence that relationship has been broken, it’s very difficult for us to conclude that something structural has occurred," said Stephen Heffler, also of the Office of the Actuary at the CMS.

Medicare spending grew by 4.6% in 2012, down from 6.2% growth in 2011. Factors included lower spending on skilled nursing facilities; lower spending on prescriptions drugs such as Plavix (clopidogrel), which went off-patent; and lower payments to some providers mandated by the ACA.

This year, Medicare spending will grow even more slowly, in part from a continued slowdown in spending on hospitals and physicians. The automatic 2% spending from sequestration will also play a role.

Medicaid spending grew just over 2% in 2012, in part because the federal government reduced its matching rate and states employed cost-containment efforts. Medicaid is expected to grow by almost 5% in 2013, partly because primary care physicians were being paid at the higher rate.

In 2014, when millions are expected to gain coverage through the ACA, health spending is expected to grow by 6% – almost 2% faster than expected if the law were not in effect. The main spending drivers in 2014 will be growth in Medicaid and growth in private health insurance.

There is a projected 7% increase in spending on physician services in 2014 – compared to just under 5% in 2012 and around 4% in 2013. That 7% figure would drop to a little under 5% if Congress allows the scheduled 25% cut in physician payments – mandated by the SGR – in January.

[email protected]

Two new smartphone apps aim to help log drug, device, and diagnostic manufacturer payments to doctors and health care providers, as called for by the Affordable Care Act.

To promote transparency in relationships between providers and industry, the ACA requires that manufacturers track and report payments for consulting, honoraria, and more.

Courtesy of Centers for Medicare & Medicaid Services

Originally known as the Sunshine Act, the effort is now called the Open Payments Program by the Centers for Medicare and Medicaid Services (CMS).

While physicians are not required to inventory anything of value they receive from manufacturers, CMS and many medical professional societies advise that they do so.

The app for physicians – Open Payments for Physicians – is designed to help doctors keep tabs on all their transactions in real time. Users can manually enter all the information regarding a particular transaction, for example, the receipt of a grant payment or a gift that’s worth more than $10.

The app is free and can be downloaded from the iTunes App Store or from Google Play.

CMS also created an app for industry representatives to use (Open Payments for Industry).

Industry users and physician users can exchange information with their apps. By using a built-in QR (quick response) code reader, the manufacturer can transfer a record of a transaction to the physician for review, according to the agency.

In a blog post, CMS Program Integrity Director Dr. Peter Budetti said the agency’s "foray into mobile technology is about providing user-friendly tools for doctors, manufacturers, and others in the health care industry to use in working with us to implement the law in a smart way."

The idea is that physicians can use the records contained in the app to compare what’s reported by manufacturers to CMS. There is a 45-day lag between when the data are reported to CMS and posted publicly. Physicians have that window to challenge the reports before they are posted on the Open Payments website. Corrections can be made later, but the erroneous data will likely stay public for awhile.

The first year of the program will be a little bit more forgiving. Data collected beginning Aug. 1 won’t be publicly reported until September 2014.

The apps can’t be used to directly transfer data to CMS, said the agency, which added that although it developed the apps, it will not "validate the accuracy of data stored in the apps, nor will it be responsible for protecting data stored in the apps."

[email protected]

Two new smartphone apps aim to help log drug, device, and diagnostic manufacturer payments to doctors and health care providers, as called for by the Affordable Care Act.

To promote transparency in relationships between providers and industry, the ACA requires that manufacturers track and report payments for consulting, honoraria, and more.

Courtesy of Centers for Medicare & Medicaid Services

Originally known as the Sunshine Act, the effort is now called the Open Payments Program by the Centers for Medicare and Medicaid Services (CMS).

While physicians are not required to inventory anything of value they receive from manufacturers, CMS and many medical professional societies advise that they do so.

The app for physicians – Open Payments for Physicians – is designed to help doctors keep tabs on all their transactions in real time. Users can manually enter all the information regarding a particular transaction, for example, the receipt of a grant payment or a gift that’s worth more than $10.

The app is free and can be downloaded from the iTunes App Store or from Google Play.

CMS also created an app for industry representatives to use (Open Payments for Industry).

Industry users and physician users can exchange information with their apps. By using a built-in QR (quick response) code reader, the manufacturer can transfer a record of a transaction to the physician for review, according to the agency.

In a blog post, CMS Program Integrity Director Dr. Peter Budetti said the agency’s "foray into mobile technology is about providing user-friendly tools for doctors, manufacturers, and others in the health care industry to use in working with us to implement the law in a smart way."

The idea is that physicians can use the records contained in the app to compare what’s reported by manufacturers to CMS. There is a 45-day lag between when the data are reported to CMS and posted publicly. Physicians have that window to challenge the reports before they are posted on the Open Payments website. Corrections can be made later, but the erroneous data will likely stay public for awhile.

The first year of the program will be a little bit more forgiving. Data collected beginning Aug. 1 won’t be publicly reported until September 2014.

The apps can’t be used to directly transfer data to CMS, said the agency, which added that although it developed the apps, it will not "validate the accuracy of data stored in the apps, nor will it be responsible for protecting data stored in the apps."

[email protected]

Two new smartphone apps aim to help log drug, device, and diagnostic manufacturer payments to doctors and health care providers, as called for by the Affordable Care Act.

To promote transparency in relationships between providers and industry, the ACA requires that manufacturers track and report payments for consulting, honoraria, and more.

Courtesy of Centers for Medicare & Medicaid Services

Originally known as the Sunshine Act, the effort is now called the Open Payments Program by the Centers for Medicare and Medicaid Services (CMS).

While physicians are not required to inventory anything of value they receive from manufacturers, CMS and many medical professional societies advise that they do so.

The app for physicians – Open Payments for Physicians – is designed to help doctors keep tabs on all their transactions in real time. Users can manually enter all the information regarding a particular transaction, for example, the receipt of a grant payment or a gift that’s worth more than $10.

The app is free and can be downloaded from the iTunes App Store or from Google Play.

CMS also created an app for industry representatives to use (Open Payments for Industry).

Industry users and physician users can exchange information with their apps. By using a built-in QR (quick response) code reader, the manufacturer can transfer a record of a transaction to the physician for review, according to the agency.

In a blog post, CMS Program Integrity Director Dr. Peter Budetti said the agency’s "foray into mobile technology is about providing user-friendly tools for doctors, manufacturers, and others in the health care industry to use in working with us to implement the law in a smart way."

The idea is that physicians can use the records contained in the app to compare what’s reported by manufacturers to CMS. There is a 45-day lag between when the data are reported to CMS and posted publicly. Physicians have that window to challenge the reports before they are posted on the Open Payments website. Corrections can be made later, but the erroneous data will likely stay public for awhile.

The first year of the program will be a little bit more forgiving. Data collected beginning Aug. 1 won’t be publicly reported until September 2014.

The apps can’t be used to directly transfer data to CMS, said the agency, which added that although it developed the apps, it will not "validate the accuracy of data stored in the apps, nor will it be responsible for protecting data stored in the apps."

[email protected]

WASHINGTON – Results from a planned interim analysis show that using a combination of simeprevir and sofosbuvir as hepatitis C therapy achieved slightly higher sustained viral response in HCV genotype 1–infected patients at 4 and 12 weeks post treatment, suggesting that it may not be necessary to add in ribavirin.

That’s according to lead author Dr. Ira M. Jacobson, medical director of the Center for the Study of Hepatitis C at the Weill Cornell Medical College, New York, who spoke at the annual meeting of the American Association for the Study of Liver Diseases.

Alicia Ault/IMNG Medical Media

Dr. Jacobson presented results from the four-arm, two-cohort, phase IIa COSMOS (Combination of Simeprevir and Sofosbuvir in HCV Genotype 1–Infected Patients) study. He reported on the final sustained viral response (SVR)12 for both arms of cohort 1 and the interim SVR4 for the 12-week arms of cohort 2. The two cohorts were enrolled simultaneously.

Patients were randomized to simeprevir 150 mg once daily plus sofosbuvir 400 mg once daily either with or without ribavirin for 12 or 24 weeks. Simeprevir is an investigational NS3/4A protease inhibitor jointly developed by Janssen R&D Ireland and Medivir. Sofosbuvir is an investigational nucleotide inhibitor developed by Gilead Sciences.

Cohort 1, with 80 patients, had a METAVIR score of F0-F2 and had previously not responded to pegylated interferon plus ribavirin. METAVIR is an algorithm for establishing degree of fibrosis, with 0 being no fibrosis and 4 being cirrhosis. There were four arms of cohort 1: 24 patients received the triple drug regimen for 24 weeks, 15 received simeprevir plus sofosbuvir for 24 weeks, 27 received the triple therapy for 12 weeks, and 14 were given simeprevir plus sofosbuvir for 12 weeks.

Cohort 2, with 87 patients, consisted of treatment-naive or prior null responders and those with a METAVIR score of F3-F4. In the four arms studied, 30 received triple therapy for 24 weeks, 16 received simeprevir plus sofosbuvir for 24 weeks, 27 got triple therapy for 12 weeks, and 14 received simeprevir plus sofosbuvir for 12 weeks. There was an even split in each arm between treatment-naive and null responders.

At the planned interim analysis, all patients in both cohorts had completed 12 weeks of therapy. In cohort 1, all patients – with the exception of three in the first arm and one in the second arm – had completed 24 weeks of therapy. All cohort 2 patients were continuing on study drugs, with the exception of two patients who discontinued triple therapy and one who stopped taking the combination of simeprevir plus sofosbuvir.

In cohort 1, 96% of those who took triple drug therapy for 12 weeks achieved an SVR12, compared with 93% of those on the dual-drug regimen. The SVR12 in those who received 24 weeks of therapy was 79% for triple therapy and 93% for dual therapy.

For cohort 2, the SVR4 for dual therapy was 100% after 12 weeks of treatment, compared with 96% for the triple therapy. All treatment-naive patients achieved an SVR4 while taking either triple or dual therapy. All prior null responders taking dual therapy also achieved an SVR4, while only 93% of those on the triple therapy achieved an SVR4.

When looked at by HCV GT1 subtype, the results show that patients with the Q80K polymorphism did not fare as well. In cohort 1, 89% of patients with that polymorphism achieved an SVR12, compared with 100% of those with GT1a or 1b without Q80K. In cohort 2, 91% of those with the polymorphism achieved an SVR4, compared with 100% of the patients with GT1a or 1b who did not have Q80K.

The most common adverse events were fatigue, headache, and nausea. Adverse events occurred in 70% of patients in the 12-week treatment group and 90% in the 24-week group. Three patients had a serious adverse event.

In late October, the Food and Drug Administration’s Antiviral Drugs Advisory Committee unanimously backed simeprevir for approval in combination with pegylated interferon and ribavirin for chronic HCV GT1 infection in adults with compensated liver disease, including cirrhosis, who are treatment naive or have failed previous interferon-based therapy. The FDA advisers said that the simeprevir regimen would likely be easier to manage than the first-generation protease inhibitors currently approved for treating chronic HCV, telaprevir and boceprevir, which require 6-12 pills daily.

The agency is expected to rule on simeprevir’s approval by Nov. 27.

Janssen paid for the study. Dr. Jacobson reported that he receives grants or research support from, serves on the speakers bureaus of, or acts as a consultant to AbbVie, Boehringer Ingelheim, Bristol-Myers Squibb, and other companies.

[email protected]

On Twitter @aliciaault

WASHINGTON – Results from a planned interim analysis show that using a combination of simeprevir and sofosbuvir as hepatitis C therapy achieved slightly higher sustained viral response in HCV genotype 1–infected patients at 4 and 12 weeks post treatment, suggesting that it may not be necessary to add in ribavirin.

That’s according to lead author Dr. Ira M. Jacobson, medical director of the Center for the Study of Hepatitis C at the Weill Cornell Medical College, New York, who spoke at the annual meeting of the American Association for the Study of Liver Diseases.

Alicia Ault/IMNG Medical Media

Dr. Jacobson presented results from the four-arm, two-cohort, phase IIa COSMOS (Combination of Simeprevir and Sofosbuvir in HCV Genotype 1–Infected Patients) study. He reported on the final sustained viral response (SVR)12 for both arms of cohort 1 and the interim SVR4 for the 12-week arms of cohort 2. The two cohorts were enrolled simultaneously.

Patients were randomized to simeprevir 150 mg once daily plus sofosbuvir 400 mg once daily either with or without ribavirin for 12 or 24 weeks. Simeprevir is an investigational NS3/4A protease inhibitor jointly developed by Janssen R&D Ireland and Medivir. Sofosbuvir is an investigational nucleotide inhibitor developed by Gilead Sciences.

Cohort 1, with 80 patients, had a METAVIR score of F0-F2 and had previously not responded to pegylated interferon plus ribavirin. METAVIR is an algorithm for establishing degree of fibrosis, with 0 being no fibrosis and 4 being cirrhosis. There were four arms of cohort 1: 24 patients received the triple drug regimen for 24 weeks, 15 received simeprevir plus sofosbuvir for 24 weeks, 27 received the triple therapy for 12 weeks, and 14 were given simeprevir plus sofosbuvir for 12 weeks.

Cohort 2, with 87 patients, consisted of treatment-naive or prior null responders and those with a METAVIR score of F3-F4. In the four arms studied, 30 received triple therapy for 24 weeks, 16 received simeprevir plus sofosbuvir for 24 weeks, 27 got triple therapy for 12 weeks, and 14 received simeprevir plus sofosbuvir for 12 weeks. There was an even split in each arm between treatment-naive and null responders.

At the planned interim analysis, all patients in both cohorts had completed 12 weeks of therapy. In cohort 1, all patients – with the exception of three in the first arm and one in the second arm – had completed 24 weeks of therapy. All cohort 2 patients were continuing on study drugs, with the exception of two patients who discontinued triple therapy and one who stopped taking the combination of simeprevir plus sofosbuvir.

In cohort 1, 96% of those who took triple drug therapy for 12 weeks achieved an SVR12, compared with 93% of those on the dual-drug regimen. The SVR12 in those who received 24 weeks of therapy was 79% for triple therapy and 93% for dual therapy.

For cohort 2, the SVR4 for dual therapy was 100% after 12 weeks of treatment, compared with 96% for the triple therapy. All treatment-naive patients achieved an SVR4 while taking either triple or dual therapy. All prior null responders taking dual therapy also achieved an SVR4, while only 93% of those on the triple therapy achieved an SVR4.

When looked at by HCV GT1 subtype, the results show that patients with the Q80K polymorphism did not fare as well. In cohort 1, 89% of patients with that polymorphism achieved an SVR12, compared with 100% of those with GT1a or 1b without Q80K. In cohort 2, 91% of those with the polymorphism achieved an SVR4, compared with 100% of the patients with GT1a or 1b who did not have Q80K.

The most common adverse events were fatigue, headache, and nausea. Adverse events occurred in 70% of patients in the 12-week treatment group and 90% in the 24-week group. Three patients had a serious adverse event.

In late October, the Food and Drug Administration’s Antiviral Drugs Advisory Committee unanimously backed simeprevir for approval in combination with pegylated interferon and ribavirin for chronic HCV GT1 infection in adults with compensated liver disease, including cirrhosis, who are treatment naive or have failed previous interferon-based therapy. The FDA advisers said that the simeprevir regimen would likely be easier to manage than the first-generation protease inhibitors currently approved for treating chronic HCV, telaprevir and boceprevir, which require 6-12 pills daily.

The agency is expected to rule on simeprevir’s approval by Nov. 27.

Janssen paid for the study. Dr. Jacobson reported that he receives grants or research support from, serves on the speakers bureaus of, or acts as a consultant to AbbVie, Boehringer Ingelheim, Bristol-Myers Squibb, and other companies.

[email protected]

On Twitter @aliciaault

WASHINGTON – Results from a planned interim analysis show that using a combination of simeprevir and sofosbuvir as hepatitis C therapy achieved slightly higher sustained viral response in HCV genotype 1–infected patients at 4 and 12 weeks post treatment, suggesting that it may not be necessary to add in ribavirin.

That’s according to lead author Dr. Ira M. Jacobson, medical director of the Center for the Study of Hepatitis C at the Weill Cornell Medical College, New York, who spoke at the annual meeting of the American Association for the Study of Liver Diseases.

Alicia Ault/IMNG Medical Media

Dr. Jacobson presented results from the four-arm, two-cohort, phase IIa COSMOS (Combination of Simeprevir and Sofosbuvir in HCV Genotype 1–Infected Patients) study. He reported on the final sustained viral response (SVR)12 for both arms of cohort 1 and the interim SVR4 for the 12-week arms of cohort 2. The two cohorts were enrolled simultaneously.

Patients were randomized to simeprevir 150 mg once daily plus sofosbuvir 400 mg once daily either with or without ribavirin for 12 or 24 weeks. Simeprevir is an investigational NS3/4A protease inhibitor jointly developed by Janssen R&D Ireland and Medivir. Sofosbuvir is an investigational nucleotide inhibitor developed by Gilead Sciences.

Cohort 1, with 80 patients, had a METAVIR score of F0-F2 and had previously not responded to pegylated interferon plus ribavirin. METAVIR is an algorithm for establishing degree of fibrosis, with 0 being no fibrosis and 4 being cirrhosis. There were four arms of cohort 1: 24 patients received the triple drug regimen for 24 weeks, 15 received simeprevir plus sofosbuvir for 24 weeks, 27 received the triple therapy for 12 weeks, and 14 were given simeprevir plus sofosbuvir for 12 weeks.

Cohort 2, with 87 patients, consisted of treatment-naive or prior null responders and those with a METAVIR score of F3-F4. In the four arms studied, 30 received triple therapy for 24 weeks, 16 received simeprevir plus sofosbuvir for 24 weeks, 27 got triple therapy for 12 weeks, and 14 received simeprevir plus sofosbuvir for 12 weeks. There was an even split in each arm between treatment-naive and null responders.

At the planned interim analysis, all patients in both cohorts had completed 12 weeks of therapy. In cohort 1, all patients – with the exception of three in the first arm and one in the second arm – had completed 24 weeks of therapy. All cohort 2 patients were continuing on study drugs, with the exception of two patients who discontinued triple therapy and one who stopped taking the combination of simeprevir plus sofosbuvir.

In cohort 1, 96% of those who took triple drug therapy for 12 weeks achieved an SVR12, compared with 93% of those on the dual-drug regimen. The SVR12 in those who received 24 weeks of therapy was 79% for triple therapy and 93% for dual therapy.

For cohort 2, the SVR4 for dual therapy was 100% after 12 weeks of treatment, compared with 96% for the triple therapy. All treatment-naive patients achieved an SVR4 while taking either triple or dual therapy. All prior null responders taking dual therapy also achieved an SVR4, while only 93% of those on the triple therapy achieved an SVR4.

When looked at by HCV GT1 subtype, the results show that patients with the Q80K polymorphism did not fare as well. In cohort 1, 89% of patients with that polymorphism achieved an SVR12, compared with 100% of those with GT1a or 1b without Q80K. In cohort 2, 91% of those with the polymorphism achieved an SVR4, compared with 100% of the patients with GT1a or 1b who did not have Q80K.

The most common adverse events were fatigue, headache, and nausea. Adverse events occurred in 70% of patients in the 12-week treatment group and 90% in the 24-week group. Three patients had a serious adverse event.

In late October, the Food and Drug Administration’s Antiviral Drugs Advisory Committee unanimously backed simeprevir for approval in combination with pegylated interferon and ribavirin for chronic HCV GT1 infection in adults with compensated liver disease, including cirrhosis, who are treatment naive or have failed previous interferon-based therapy. The FDA advisers said that the simeprevir regimen would likely be easier to manage than the first-generation protease inhibitors currently approved for treating chronic HCV, telaprevir and boceprevir, which require 6-12 pills daily.

The agency is expected to rule on simeprevir’s approval by Nov. 27.

Janssen paid for the study. Dr. Jacobson reported that he receives grants or research support from, serves on the speakers bureaus of, or acts as a consultant to AbbVie, Boehringer Ingelheim, Bristol-Myers Squibb, and other companies.

[email protected]

On Twitter @aliciaault

WASHINGTON – The use of the experimental drug sofosbuvir in combination with ribavirin successfully reduced hepatitis C virus infection recurrence in 77% of posttransplant patients 4 weeks after treatment ended, based on the initial results of an ongoing large, prospective multicenter study.

HCV recurrence is the most common cause of mortality and graft loss following transplantation, and 10%-50% of those with a recurrent infection progress to cirrhosis within 5 years, Dr. Michael R. Charlton, professor of medicine at the Mayo Clinic, Rochester, Minn., said at the annual meeting of the American Association for the Study of Liver Diseases.

Alicia Ault/IMNG Medical Media

Sofosbuvir, manufactured by Gilead Sciences, is a nucleotide analogue inhibitor of the NS5B polymerase enzyme, which plays an important role in HCV replication. The compound is active against HCV genotypes 1 (the most common genotype in the United States), 2, 3, 4, 5, and 6.

There are no approved treatments currently in the United States to prevent posttransplant HCV recurrence.

Dr. Charlton reported results for 40 patients in an ongoing open-label interferon-free study. Their mean age was 59 years, with a range of 49-75 years; 78% were male, 85% were white, 8% were black, and 3% were Hispanic. Thirty-five patients (88%) had been previously treated, with 9 of the 40 having been previously treated with protease inhibitors. The study enrollees had a mean baseline HCV RNA of 6.55 log₁₀ IU/mL. Sixteen patients (40%) had cirrhosis. The predominant genotype was 1a, found in 22 patients (55%); 11 had genotype 1b, 6 had genotype 3, and 1 had genotype 4.

In the study, posttransplant patients with recurrent HCV infection of any genotype were included. The transplant had to have occurred between 6 and 150 months prior to enrollment. Patients had to have an absence of rejection and were excluded if they took more than 5 mg of prednisone daily. Study participants were given up to 24 weeks of sofosbuvir in a daily dose of 400 mg and ribavirin starting at 400 mg daily. The ribavirin dose was increased up to 1,200 mg daily, depending on the patient’s hemoglobin levels.

At week 4 of the study, all 40 patients were HCV RNA negative. At the end of treatment, 39 of the patients who were still in the trial were HCV negative. Four weeks post treatment, 27 of 35 were negative.

Of the nine patients who relapsed post treatment, eight were male, five were genotype 1a, three were genotype 1b, and one was genotype 4. Eight of the nine had prior treatment. And five had bridging fibrosis or cirrhosis.

There were no episodes of rejection, and there were no interactions that required adjustment of immunosuppressive therapy.

The most common side effects were fatigue, arthralgia, headache, and diarrhea. Six patients had a serious adverse event. Two patients withdrew as a result of a serious adverse event, but the events were not related to sofosbuvir, said Dr. Charlton.

In late October, the Food and Drug Administration’s Antiviral Drugs Advisory Committee unanimously recommended the approval of sofosbuvir for two indications: in combination with pegylated interferon and ribavirin, for treatment-naive adults with genotype 1 and 4 infections and in combination with ribavirin, for adults with genotype 2 and 3 infections.

If approved, as is expected, the second indication will mark the first approval of a treatment for chronic hepatitis C with an interferon-free regimen, and it will be the first drug in its class to be approved. The FDA is expected to make a decision by Dec. 8. Sofosbuvir also is under review in the European Union, Australia, Canada, New Zealand, Switzerland, and Turkey, according to Gilead.

Dr. Charlton disclosed that he has received research support and consulting fees from a variety of companies, including AbbeVie, Biotest, Bristol Myers-Squibb, Gilead, Novartis, and Vertex.

The study was funded by Gilead Sciences.

[email protected]

On Twitter @aliciaault

WASHINGTON – The use of the experimental drug sofosbuvir in combination with ribavirin successfully reduced hepatitis C virus infection recurrence in 77% of posttransplant patients 4 weeks after treatment ended, based on the initial results of an ongoing large, prospective multicenter study.

HCV recurrence is the most common cause of mortality and graft loss following transplantation, and 10%-50% of those with a recurrent infection progress to cirrhosis within 5 years, Dr. Michael R. Charlton, professor of medicine at the Mayo Clinic, Rochester, Minn., said at the annual meeting of the American Association for the Study of Liver Diseases.

Alicia Ault/IMNG Medical Media

Sofosbuvir, manufactured by Gilead Sciences, is a nucleotide analogue inhibitor of the NS5B polymerase enzyme, which plays an important role in HCV replication. The compound is active against HCV genotypes 1 (the most common genotype in the United States), 2, 3, 4, 5, and 6.

There are no approved treatments currently in the United States to prevent posttransplant HCV recurrence.

Dr. Charlton reported results for 40 patients in an ongoing open-label interferon-free study. Their mean age was 59 years, with a range of 49-75 years; 78% were male, 85% were white, 8% were black, and 3% were Hispanic. Thirty-five patients (88%) had been previously treated, with 9 of the 40 having been previously treated with protease inhibitors. The study enrollees had a mean baseline HCV RNA of 6.55 log₁₀ IU/mL. Sixteen patients (40%) had cirrhosis. The predominant genotype was 1a, found in 22 patients (55%); 11 had genotype 1b, 6 had genotype 3, and 1 had genotype 4.

In the study, posttransplant patients with recurrent HCV infection of any genotype were included. The transplant had to have occurred between 6 and 150 months prior to enrollment. Patients had to have an absence of rejection and were excluded if they took more than 5 mg of prednisone daily. Study participants were given up to 24 weeks of sofosbuvir in a daily dose of 400 mg and ribavirin starting at 400 mg daily. The ribavirin dose was increased up to 1,200 mg daily, depending on the patient’s hemoglobin levels.

At week 4 of the study, all 40 patients were HCV RNA negative. At the end of treatment, 39 of the patients who were still in the trial were HCV negative. Four weeks post treatment, 27 of 35 were negative.

Of the nine patients who relapsed post treatment, eight were male, five were genotype 1a, three were genotype 1b, and one was genotype 4. Eight of the nine had prior treatment. And five had bridging fibrosis or cirrhosis.

There were no episodes of rejection, and there were no interactions that required adjustment of immunosuppressive therapy.

The most common side effects were fatigue, arthralgia, headache, and diarrhea. Six patients had a serious adverse event. Two patients withdrew as a result of a serious adverse event, but the events were not related to sofosbuvir, said Dr. Charlton.

In late October, the Food and Drug Administration’s Antiviral Drugs Advisory Committee unanimously recommended the approval of sofosbuvir for two indications: in combination with pegylated interferon and ribavirin, for treatment-naive adults with genotype 1 and 4 infections and in combination with ribavirin, for adults with genotype 2 and 3 infections.

If approved, as is expected, the second indication will mark the first approval of a treatment for chronic hepatitis C with an interferon-free regimen, and it will be the first drug in its class to be approved. The FDA is expected to make a decision by Dec. 8. Sofosbuvir also is under review in the European Union, Australia, Canada, New Zealand, Switzerland, and Turkey, according to Gilead.

Dr. Charlton disclosed that he has received research support and consulting fees from a variety of companies, including AbbeVie, Biotest, Bristol Myers-Squibb, Gilead, Novartis, and Vertex.

The study was funded by Gilead Sciences.

[email protected]

On Twitter @aliciaault

WASHINGTON – The use of the experimental drug sofosbuvir in combination with ribavirin successfully reduced hepatitis C virus infection recurrence in 77% of posttransplant patients 4 weeks after treatment ended, based on the initial results of an ongoing large, prospective multicenter study.

HCV recurrence is the most common cause of mortality and graft loss following transplantation, and 10%-50% of those with a recurrent infection progress to cirrhosis within 5 years, Dr. Michael R. Charlton, professor of medicine at the Mayo Clinic, Rochester, Minn., said at the annual meeting of the American Association for the Study of Liver Diseases.

Alicia Ault/IMNG Medical Media

Sofosbuvir, manufactured by Gilead Sciences, is a nucleotide analogue inhibitor of the NS5B polymerase enzyme, which plays an important role in HCV replication. The compound is active against HCV genotypes 1 (the most common genotype in the United States), 2, 3, 4, 5, and 6.

There are no approved treatments currently in the United States to prevent posttransplant HCV recurrence.

Dr. Charlton reported results for 40 patients in an ongoing open-label interferon-free study. Their mean age was 59 years, with a range of 49-75 years; 78% were male, 85% were white, 8% were black, and 3% were Hispanic. Thirty-five patients (88%) had been previously treated, with 9 of the 40 having been previously treated with protease inhibitors. The study enrollees had a mean baseline HCV RNA of 6.55 log₁₀ IU/mL. Sixteen patients (40%) had cirrhosis. The predominant genotype was 1a, found in 22 patients (55%); 11 had genotype 1b, 6 had genotype 3, and 1 had genotype 4.

In the study, posttransplant patients with recurrent HCV infection of any genotype were included. The transplant had to have occurred between 6 and 150 months prior to enrollment. Patients had to have an absence of rejection and were excluded if they took more than 5 mg of prednisone daily. Study participants were given up to 24 weeks of sofosbuvir in a daily dose of 400 mg and ribavirin starting at 400 mg daily. The ribavirin dose was increased up to 1,200 mg daily, depending on the patient’s hemoglobin levels.

At week 4 of the study, all 40 patients were HCV RNA negative. At the end of treatment, 39 of the patients who were still in the trial were HCV negative. Four weeks post treatment, 27 of 35 were negative.

Of the nine patients who relapsed post treatment, eight were male, five were genotype 1a, three were genotype 1b, and one was genotype 4. Eight of the nine had prior treatment. And five had bridging fibrosis or cirrhosis.

There were no episodes of rejection, and there were no interactions that required adjustment of immunosuppressive therapy.

The most common side effects were fatigue, arthralgia, headache, and diarrhea. Six patients had a serious adverse event. Two patients withdrew as a result of a serious adverse event, but the events were not related to sofosbuvir, said Dr. Charlton.

In late October, the Food and Drug Administration’s Antiviral Drugs Advisory Committee unanimously recommended the approval of sofosbuvir for two indications: in combination with pegylated interferon and ribavirin, for treatment-naive adults with genotype 1 and 4 infections and in combination with ribavirin, for adults with genotype 2 and 3 infections.

If approved, as is expected, the second indication will mark the first approval of a treatment for chronic hepatitis C with an interferon-free regimen, and it will be the first drug in its class to be approved. The FDA is expected to make a decision by Dec. 8. Sofosbuvir also is under review in the European Union, Australia, Canada, New Zealand, Switzerland, and Turkey, according to Gilead.

Dr. Charlton disclosed that he has received research support and consulting fees from a variety of companies, including AbbeVie, Biotest, Bristol Myers-Squibb, Gilead, Novartis, and Vertex.

The study was funded by Gilead Sciences.

[email protected]

On Twitter @aliciaault

WASHINGTON – Using the ECHO model of primary care to treat hepatitis C is cost saving in 35% of patients and very cost effective overall, according to a retrospective analysis presented by Dr. John B. Wong, at the annual meeting of the American Association for the Study of Liver Diseases.

Project ECHO (Extension for Community Healthcare Outcomes) was begun at the University of New Mexico, Albuquerque, and has been adopted by the Veterans Affairs department, among other organizations, as a means of extending primary care to those who might not otherwise have access.

"This is not about the antiviral treatment, it’s about the engagement of primary care physicians, to train them, educate them, and help them take care of patients with hepatitis C," said Dr. Wong, chief of the division of clinical decision making at Tufts Medical Center, Boston. "It’s about increasing access," he added.

Dr. Wong presented the results of a cost-effectiveness analysis he and his Tufts colleagues conducted on a study of ECHO’s effectiveness in treating HCV, published in the New England Journal of Medicine in 2011 (N. Engl. J. Med. 2011;364:2199-207).

That prospective cohort study evaluated ECHO in the HCV treatment of 261 patients at 16 community sites and 5 prisons.

Dr. Wong and his colleagues updated the data, using information from the United Network for Organ Sharing; the Surveillance, Epidemiology and End Results Program; and life tables from the Centers for Disease Control and Prevention. They also used the previously established and validated Markov cohort simulation model to compare ECHO to no antiviral therapy for each of the 261 patients.

Costs taken into account included expenses for drugs, physician visits, lab tests, adverse events, HCV disease complications, and multidisciplinary ECHO personnel (physician, pharmacist, psychiatrist, nurse manager, coordinator, and user support analyst).

Dr. Wong said that the researchers also performed an analysis of the cost of antiviral treatment if patients traveled to the academic center to receive care instead of having ECHO come to them. Travel costs included mileage, patient time, and guard costs for prisoners. The investigators used quality-of-life adjustments to account for antiviral treatment and disease-related morbidity, and discounted costs and effectiveness at 3% a year.

They calculated that ECHO led to a 63% reduction in lifetime cirrhosis when compared with no antiviral therapy. Hepatocellular carcinoma declined by 45% and liver death by 46%. There was a 4.4-year gain in life expectancy overall, and a 5.5-year gain in quality-adjusted life expectancy.

For 42% of the 261 patients, the incremental effectiveness did not outweigh the cost – and the opportunity cost – of taking an antiviral, said Dr. Wong. In another 23% of patients, the antiviral therapy extended life, but in the end, when the costs of the disease and the antivirals were added in, there was an extra cost associated with the therapy.

But in 35% of the patients, there was an extension of life – as much as 8 additional years – and a reduction in cost of treatment, as much as $40,000.

The incremental cost-effectiveness ratio – a formula calculated by dividing the additional cost by the additional benefit – for ECHO is $3,700, Dr. Wong said. The World Health Organization considers anything less than the per capita gross domestic product of a country to be "very cost effective," and anything less than three times that per capita number to be "cost effective," he said. He noted that the mean GDP in the United States is $50,000, putting the ECHO intervention well within the WHO’s range for very cost effective.

The gains were even greater for patients living in correctional institutions, with an incremental cost-effectiveness ratio of $1,400.

The study is limited by the fact that it is a computer simulation, and some travel data were missing, said Dr. Wong.

Additional trials are needed to confirm the results, he said.

The University of New Mexico recently started an institute to spread the ECHO model.

Dr. Wong reported no conflicts of interest.

mailto:[email protected]

On Twitter @aliciaault

WASHINGTON – Using the ECHO model of primary care to treat hepatitis C is cost saving in 35% of patients and very cost effective overall, according to a retrospective analysis presented by Dr. John B. Wong, at the annual meeting of the American Association for the Study of Liver Diseases.

Project ECHO (Extension for Community Healthcare Outcomes) was begun at the University of New Mexico, Albuquerque, and has been adopted by the Veterans Affairs department, among other organizations, as a means of extending primary care to those who might not otherwise have access.

"This is not about the antiviral treatment, it’s about the engagement of primary care physicians, to train them, educate them, and help them take care of patients with hepatitis C," said Dr. Wong, chief of the division of clinical decision making at Tufts Medical Center, Boston. "It’s about increasing access," he added.

Dr. Wong presented the results of a cost-effectiveness analysis he and his Tufts colleagues conducted on a study of ECHO’s effectiveness in treating HCV, published in the New England Journal of Medicine in 2011 (N. Engl. J. Med. 2011;364:2199-207).

That prospective cohort study evaluated ECHO in the HCV treatment of 261 patients at 16 community sites and 5 prisons.

Dr. Wong and his colleagues updated the data, using information from the United Network for Organ Sharing; the Surveillance, Epidemiology and End Results Program; and life tables from the Centers for Disease Control and Prevention. They also used the previously established and validated Markov cohort simulation model to compare ECHO to no antiviral therapy for each of the 261 patients.

Costs taken into account included expenses for drugs, physician visits, lab tests, adverse events, HCV disease complications, and multidisciplinary ECHO personnel (physician, pharmacist, psychiatrist, nurse manager, coordinator, and user support analyst).

Dr. Wong said that the researchers also performed an analysis of the cost of antiviral treatment if patients traveled to the academic center to receive care instead of having ECHO come to them. Travel costs included mileage, patient time, and guard costs for prisoners. The investigators used quality-of-life adjustments to account for antiviral treatment and disease-related morbidity, and discounted costs and effectiveness at 3% a year.

They calculated that ECHO led to a 63% reduction in lifetime cirrhosis when compared with no antiviral therapy. Hepatocellular carcinoma declined by 45% and liver death by 46%. There was a 4.4-year gain in life expectancy overall, and a 5.5-year gain in quality-adjusted life expectancy.

For 42% of the 261 patients, the incremental effectiveness did not outweigh the cost – and the opportunity cost – of taking an antiviral, said Dr. Wong. In another 23% of patients, the antiviral therapy extended life, but in the end, when the costs of the disease and the antivirals were added in, there was an extra cost associated with the therapy.

But in 35% of the patients, there was an extension of life – as much as 8 additional years – and a reduction in cost of treatment, as much as $40,000.

The incremental cost-effectiveness ratio – a formula calculated by dividing the additional cost by the additional benefit – for ECHO is $3,700, Dr. Wong said. The World Health Organization considers anything less than the per capita gross domestic product of a country to be "very cost effective," and anything less than three times that per capita number to be "cost effective," he said. He noted that the mean GDP in the United States is $50,000, putting the ECHO intervention well within the WHO’s range for very cost effective.

The gains were even greater for patients living in correctional institutions, with an incremental cost-effectiveness ratio of $1,400.

The study is limited by the fact that it is a computer simulation, and some travel data were missing, said Dr. Wong.

Additional trials are needed to confirm the results, he said.

The University of New Mexico recently started an institute to spread the ECHO model.

Dr. Wong reported no conflicts of interest.

mailto:[email protected]

On Twitter @aliciaault

WASHINGTON – Using the ECHO model of primary care to treat hepatitis C is cost saving in 35% of patients and very cost effective overall, according to a retrospective analysis presented by Dr. John B. Wong, at the annual meeting of the American Association for the Study of Liver Diseases.

Project ECHO (Extension for Community Healthcare Outcomes) was begun at the University of New Mexico, Albuquerque, and has been adopted by the Veterans Affairs department, among other organizations, as a means of extending primary care to those who might not otherwise have access.

"This is not about the antiviral treatment, it’s about the engagement of primary care physicians, to train them, educate them, and help them take care of patients with hepatitis C," said Dr. Wong, chief of the division of clinical decision making at Tufts Medical Center, Boston. "It’s about increasing access," he added.

Dr. Wong presented the results of a cost-effectiveness analysis he and his Tufts colleagues conducted on a study of ECHO’s effectiveness in treating HCV, published in the New England Journal of Medicine in 2011 (N. Engl. J. Med. 2011;364:2199-207).

That prospective cohort study evaluated ECHO in the HCV treatment of 261 patients at 16 community sites and 5 prisons.

Dr. Wong and his colleagues updated the data, using information from the United Network for Organ Sharing; the Surveillance, Epidemiology and End Results Program; and life tables from the Centers for Disease Control and Prevention. They also used the previously established and validated Markov cohort simulation model to compare ECHO to no antiviral therapy for each of the 261 patients.

Costs taken into account included expenses for drugs, physician visits, lab tests, adverse events, HCV disease complications, and multidisciplinary ECHO personnel (physician, pharmacist, psychiatrist, nurse manager, coordinator, and user support analyst).

Dr. Wong said that the researchers also performed an analysis of the cost of antiviral treatment if patients traveled to the academic center to receive care instead of having ECHO come to them. Travel costs included mileage, patient time, and guard costs for prisoners. The investigators used quality-of-life adjustments to account for antiviral treatment and disease-related morbidity, and discounted costs and effectiveness at 3% a year.

They calculated that ECHO led to a 63% reduction in lifetime cirrhosis when compared with no antiviral therapy. Hepatocellular carcinoma declined by 45% and liver death by 46%. There was a 4.4-year gain in life expectancy overall, and a 5.5-year gain in quality-adjusted life expectancy.

For 42% of the 261 patients, the incremental effectiveness did not outweigh the cost – and the opportunity cost – of taking an antiviral, said Dr. Wong. In another 23% of patients, the antiviral therapy extended life, but in the end, when the costs of the disease and the antivirals were added in, there was an extra cost associated with the therapy.

But in 35% of the patients, there was an extension of life – as much as 8 additional years – and a reduction in cost of treatment, as much as $40,000.

The incremental cost-effectiveness ratio – a formula calculated by dividing the additional cost by the additional benefit – for ECHO is $3,700, Dr. Wong said. The World Health Organization considers anything less than the per capita gross domestic product of a country to be "very cost effective," and anything less than three times that per capita number to be "cost effective," he said. He noted that the mean GDP in the United States is $50,000, putting the ECHO intervention well within the WHO’s range for very cost effective.

The gains were even greater for patients living in correctional institutions, with an incremental cost-effectiveness ratio of $1,400.

The study is limited by the fact that it is a computer simulation, and some travel data were missing, said Dr. Wong.

Additional trials are needed to confirm the results, he said.

The University of New Mexico recently started an institute to spread the ECHO model.

Dr. Wong reported no conflicts of interest.

mailto:[email protected]

On Twitter @aliciaault

WASHINGTON – Using the ECHO model of primary care to treat hepatitis C is cost saving in 35% of patients and very cost effective overall, according to a retrospective analysis presented by Dr. John B. Wong, at the annual meeting of the American Association for the Study of Liver Diseases.

Project ECHO (Extension for Community Healthcare Outcomes) was begun at the University of New Mexico, Albuquerque, and has been adopted by the Veterans Affairs department, among other organizations, as a means of extending primary care to those who might not otherwise have access.

Alicia Ault/IMNG Medical Media

"This is not about the antiviral treatment, it’s about the engagement of primary care physicians, to train them, educate them, and help them take care of patients with hepatitis C," said Dr. Wong, chief of the division of clinical decision making at Tufts Medical Center, Boston. "It’s about increasing access," he added.

Dr. Wong presented the results of a cost-effectiveness analysis he and his Tufts colleagues conducted on a study of ECHO’s effectiveness in treating HCV, published in the New England Journal of Medicine in 2011 (N. Engl. J. Med. 2011;364:2199-207).

That prospective cohort study evaluated ECHO in the HCV treatment of 261 patients at 16 community sites and 5 prisons.

Dr. Wong and his colleagues updated the data, using information from the United Network for Organ Sharing; the Surveillance, Epidemiology and End Results Program; and life tables from the Centers for Disease Control and Prevention. They also used the previously established and validated Markov cohort simulation model to compare ECHO to no antiviral therapy for each of the 261 patients.

Costs taken into account included expenses for drugs, physician visits, lab tests, adverse events, HCV disease complications, and multidisciplinary ECHO personnel (physician, pharmacist, psychiatrist, nurse manager, coordinator, and user support analyst).

Dr. Wong said that the researchers also performed an analysis of the cost of antiviral treatment if patients traveled to the academic center to receive care instead of having ECHO come to them. Travel costs included mileage, patient time, and guard costs for prisoners. The investigators used quality-of-life adjustments to account for antiviral treatment and disease-related morbidity, and discounted costs and effectiveness at 3% a year.

They calculated that ECHO led to a 63% reduction in lifetime cirrhosis when compared with no antiviral therapy. Hepatocellular carcinoma declined by 45% and liver death by 46%. There was a 4.4-year gain in life expectancy overall, and a 5.5-year gain in quality-adjusted life expectancy.

For 42% of the 261 patients, the incremental effectiveness did not outweigh the cost – and the opportunity cost – of taking an antiviral, said Dr. Wong. In another 23% of patients, the antiviral therapy extended life, but in the end, when the costs of the disease and the antivirals were added in, there was an extra cost associated with the therapy.

But in 35% of the patients, there was an extension of life – as much as 8 additional years – and a reduction in cost of treatment, as much as $40,000.

The incremental cost-effectiveness ratio – a formula calculated by dividing the additional cost by the additional benefit – for ECHO is $3,700, Dr. Wong said. The World Health Organization considers anything less than the per capita gross domestic product of a country to be "very cost effective," and anything less than three times that per capita number to be "cost effective," he said. He noted that the mean GDP in the United States is $50,000, putting the ECHO intervention well within the WHO’s range for very cost effective.

The gains were even greater for patients living in correctional institutions, with an incremental cost-effectiveness ratio of $1,400.

The study is limited by the fact that it is a computer simulation, and some travel data were missing, said Dr. Wong.

Additional trials are needed to confirm the results, he said.

The University of New Mexico recently started an institute to spread the ECHO model.

Dr. Wong reported no conflicts of interest.

mailto:[email protected]

On Twitter @aliciaault

WASHINGTON – Using the ECHO model of primary care to treat hepatitis C is cost saving in 35% of patients and very cost effective overall, according to a retrospective analysis presented by Dr. John B. Wong, at the annual meeting of the American Association for the Study of Liver Diseases.

Project ECHO (Extension for Community Healthcare Outcomes) was begun at the University of New Mexico, Albuquerque, and has been adopted by the Veterans Affairs department, among other organizations, as a means of extending primary care to those who might not otherwise have access.

Alicia Ault/IMNG Medical Media

"This is not about the antiviral treatment, it’s about the engagement of primary care physicians, to train them, educate them, and help them take care of patients with hepatitis C," said Dr. Wong, chief of the division of clinical decision making at Tufts Medical Center, Boston. "It’s about increasing access," he added.

Dr. Wong presented the results of a cost-effectiveness analysis he and his Tufts colleagues conducted on a study of ECHO’s effectiveness in treating HCV, published in the New England Journal of Medicine in 2011 (N. Engl. J. Med. 2011;364:2199-207).

That prospective cohort study evaluated ECHO in the HCV treatment of 261 patients at 16 community sites and 5 prisons.

Dr. Wong and his colleagues updated the data, using information from the United Network for Organ Sharing; the Surveillance, Epidemiology and End Results Program; and life tables from the Centers for Disease Control and Prevention. They also used the previously established and validated Markov cohort simulation model to compare ECHO to no antiviral therapy for each of the 261 patients.

Costs taken into account included expenses for drugs, physician visits, lab tests, adverse events, HCV disease complications, and multidisciplinary ECHO personnel (physician, pharmacist, psychiatrist, nurse manager, coordinator, and user support analyst).

Dr. Wong said that the researchers also performed an analysis of the cost of antiviral treatment if patients traveled to the academic center to receive care instead of having ECHO come to them. Travel costs included mileage, patient time, and guard costs for prisoners. The investigators used quality-of-life adjustments to account for antiviral treatment and disease-related morbidity, and discounted costs and effectiveness at 3% a year.

They calculated that ECHO led to a 63% reduction in lifetime cirrhosis when compared with no antiviral therapy. Hepatocellular carcinoma declined by 45% and liver death by 46%. There was a 4.4-year gain in life expectancy overall, and a 5.5-year gain in quality-adjusted life expectancy.

For 42% of the 261 patients, the incremental effectiveness did not outweigh the cost – and the opportunity cost – of taking an antiviral, said Dr. Wong. In another 23% of patients, the antiviral therapy extended life, but in the end, when the costs of the disease and the antivirals were added in, there was an extra cost associated with the therapy.

But in 35% of the patients, there was an extension of life – as much as 8 additional years – and a reduction in cost of treatment, as much as $40,000.

The incremental cost-effectiveness ratio – a formula calculated by dividing the additional cost by the additional benefit – for ECHO is $3,700, Dr. Wong said. The World Health Organization considers anything less than the per capita gross domestic product of a country to be "very cost effective," and anything less than three times that per capita number to be "cost effective," he said. He noted that the mean GDP in the United States is $50,000, putting the ECHO intervention well within the WHO’s range for very cost effective.

The gains were even greater for patients living in correctional institutions, with an incremental cost-effectiveness ratio of $1,400.

The study is limited by the fact that it is a computer simulation, and some travel data were missing, said Dr. Wong.

Additional trials are needed to confirm the results, he said.

The University of New Mexico recently started an institute to spread the ECHO model.

Dr. Wong reported no conflicts of interest.

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On Twitter @aliciaault

WASHINGTON – Using the ECHO model of primary care to treat hepatitis C is cost saving in 35% of patients and very cost effective overall, according to a retrospective analysis presented by Dr. John B. Wong, at the annual meeting of the American Association for the Study of Liver Diseases.

Project ECHO (Extension for Community Healthcare Outcomes) was begun at the University of New Mexico, Albuquerque, and has been adopted by the Veterans Affairs department, among other organizations, as a means of extending primary care to those who might not otherwise have access.

Alicia Ault/IMNG Medical Media

"This is not about the antiviral treatment, it’s about the engagement of primary care physicians, to train them, educate them, and help them take care of patients with hepatitis C," said Dr. Wong, chief of the division of clinical decision making at Tufts Medical Center, Boston. "It’s about increasing access," he added.

Dr. Wong presented the results of a cost-effectiveness analysis he and his Tufts colleagues conducted on a study of ECHO’s effectiveness in treating HCV, published in the New England Journal of Medicine in 2011 (N. Engl. J. Med. 2011;364:2199-207).

That prospective cohort study evaluated ECHO in the HCV treatment of 261 patients at 16 community sites and 5 prisons.

Dr. Wong and his colleagues updated the data, using information from the United Network for Organ Sharing; the Surveillance, Epidemiology and End Results Program; and life tables from the Centers for Disease Control and Prevention. They also used the previously established and validated Markov cohort simulation model to compare ECHO to no antiviral therapy for each of the 261 patients.

Costs taken into account included expenses for drugs, physician visits, lab tests, adverse events, HCV disease complications, and multidisciplinary ECHO personnel (physician, pharmacist, psychiatrist, nurse manager, coordinator, and user support analyst).

Dr. Wong said that the researchers also performed an analysis of the cost of antiviral treatment if patients traveled to the academic center to receive care instead of having ECHO come to them. Travel costs included mileage, patient time, and guard costs for prisoners. The investigators used quality-of-life adjustments to account for antiviral treatment and disease-related morbidity, and discounted costs and effectiveness at 3% a year.

They calculated that ECHO led to a 63% reduction in lifetime cirrhosis when compared with no antiviral therapy. Hepatocellular carcinoma declined by 45% and liver death by 46%. There was a 4.4-year gain in life expectancy overall, and a 5.5-year gain in quality-adjusted life expectancy.

For 42% of the 261 patients, the incremental effectiveness did not outweigh the cost – and the opportunity cost – of taking an antiviral, said Dr. Wong. In another 23% of patients, the antiviral therapy extended life, but in the end, when the costs of the disease and the antivirals were added in, there was an extra cost associated with the therapy.

But in 35% of the patients, there was an extension of life – as much as 8 additional years – and a reduction in cost of treatment, as much as $40,000.

The incremental cost-effectiveness ratio – a formula calculated by dividing the additional cost by the additional benefit – for ECHO is $3,700, Dr. Wong said. The World Health Organization considers anything less than the per capita gross domestic product of a country to be "very cost effective," and anything less than three times that per capita number to be "cost effective," he said. He noted that the mean GDP in the United States is $50,000, putting the ECHO intervention well within the WHO’s range for very cost effective.

The gains were even greater for patients living in correctional institutions, with an incremental cost-effectiveness ratio of $1,400.

The study is limited by the fact that it is a computer simulation, and some travel data were missing, said Dr. Wong.

Additional trials are needed to confirm the results, he said.

The University of New Mexico recently started an institute to spread the ECHO model.

Dr. Wong reported no conflicts of interest.

mailto:[email protected]

On Twitter @aliciaault

WASHINGTON – A pilot study screening for hepatitis C in the emergency department found that at least 12% of baby boomers who were previously unaware of their HCV status were positive for the virus.

Infection was confirmed in almost 9% of HCV-positive patients, lead author Dr. James W. Galbraith reported at the annual meeting of the American Association for the Study of Liver Diseases.

Dr. Galbraith, an associate professor of emergency medicine at the University of Alabama, Birmingham, reported on initial results of a screening program funded by the Centers for Disease Control and Prevention that began in September. Results are currently tabulated through Oct. 17. During that time, there were 2,363 unique ED visits by patients born in the years 1945 to 1965. Seventy-three percent (1,721) agreed to answer two questions given by a triage nurse: Have you ever been tested for HCV, and if yes, are you aware of that result? Seventy-five percent, or 1,287 patients, did not know their status and were offered testing.

Alicia Ault/IMNG Medical Media

Of those, 90% (1,148) accepted the antibody test. Patients were excluded from testing if they were medically or surgically unstable, had known HCV infection, or if they chose to opt out.

Antibody tests were performed on 984 of those patients, with results returned to ED physicians within 30-60 minutes. Eighty-eight percent had negative results, but 12%, or 118 patients, were HCV positive.

Researchers attempt to verify positive test results with polymerase chain reaction testing, but it is not always easy to do so, said Dr. Galbraith. Patients must be kept for a new blood draw, and many have already left the ED. Testing is also expensive, he noted.

Overall, men were significantly more likely than were women to test positive (17% compared with 8%). There was no significant difference in HCV positivity rates between whites and African Americans (11% vs. 13%). Patients without insurance or those on Medicaid or other public insurance plans were significantly more likely to be positive, with 17% in each of those groups exhibiting reactivity on the antibody assay, compared with 5% of insured patients.

When patients are determined to be HCV positive, ED physicians counsel and direct them to resources in the community, including specialists. Dr. Galbraith said that the numbers of baby boomers being found to be HCV positive are likely to overwhelm the available specialists.

By September 2014, Dr. Galbraith said, his ED is likely to screen 8,000 baby boomers. If the prevalence rate remains stable, that would mean 864 who are HCV positive and more than 600 with confirmed infection, he said.

Still, it’s important to screen, said Dr. Galbraith, adding that given the study results, "the implication is that the ED may be an important venue for HCV screening."

Two federal entities have called for increased screening. In May, the CDC urged HCV testing for all Americans born between 1945 and 1965.

The U.S. Preventive Services Task Force followed in June, recommending routine HCV screening for high risk Americans, and one-time screening for adults born between 1945 and 1965.

The study was funded by the Centers for Disease Control and Prevention. Dr. Galbraith reported no disclosures.

[email protected]

On Twitter @aliciaault

WASHINGTON – A pilot study screening for hepatitis C in the emergency department found that at least 12% of baby boomers who were previously unaware of their HCV status were positive for the virus.

Infection was confirmed in almost 9% of HCV-positive patients, lead author Dr. James W. Galbraith reported at the annual meeting of the American Association for the Study of Liver Diseases.

Dr. Galbraith, an associate professor of emergency medicine at the University of Alabama, Birmingham, reported on initial results of a screening program funded by the Centers for Disease Control and Prevention that began in September. Results are currently tabulated through Oct. 17. During that time, there were 2,363 unique ED visits by patients born in the years 1945 to 1965. Seventy-three percent (1,721) agreed to answer two questions given by a triage nurse: Have you ever been tested for HCV, and if yes, are you aware of that result? Seventy-five percent, or 1,287 patients, did not know their status and were offered testing.

Alicia Ault/IMNG Medical Media

Of those, 90% (1,148) accepted the antibody test. Patients were excluded from testing if they were medically or surgically unstable, had known HCV infection, or if they chose to opt out.

Antibody tests were performed on 984 of those patients, with results returned to ED physicians within 30-60 minutes. Eighty-eight percent had negative results, but 12%, or 118 patients, were HCV positive.

Researchers attempt to verify positive test results with polymerase chain reaction testing, but it is not always easy to do so, said Dr. Galbraith. Patients must be kept for a new blood draw, and many have already left the ED. Testing is also expensive, he noted.

Overall, men were significantly more likely than were women to test positive (17% compared with 8%). There was no significant difference in HCV positivity rates between whites and African Americans (11% vs. 13%). Patients without insurance or those on Medicaid or other public insurance plans were significantly more likely to be positive, with 17% in each of those groups exhibiting reactivity on the antibody assay, compared with 5% of insured patients.

When patients are determined to be HCV positive, ED physicians counsel and direct them to resources in the community, including specialists. Dr. Galbraith said that the numbers of baby boomers being found to be HCV positive are likely to overwhelm the available specialists.

By September 2014, Dr. Galbraith said, his ED is likely to screen 8,000 baby boomers. If the prevalence rate remains stable, that would mean 864 who are HCV positive and more than 600 with confirmed infection, he said.

Still, it’s important to screen, said Dr. Galbraith, adding that given the study results, "the implication is that the ED may be an important venue for HCV screening."

Two federal entities have called for increased screening. In May, the CDC urged HCV testing for all Americans born between 1945 and 1965.

The U.S. Preventive Services Task Force followed in June, recommending routine HCV screening for high risk Americans, and one-time screening for adults born between 1945 and 1965.

The study was funded by the Centers for Disease Control and Prevention. Dr. Galbraith reported no disclosures.

[email protected]

On Twitter @aliciaault

WASHINGTON – A pilot study screening for hepatitis C in the emergency department found that at least 12% of baby boomers who were previously unaware of their HCV status were positive for the virus.

Infection was confirmed in almost 9% of HCV-positive patients, lead author Dr. James W. Galbraith reported at the annual meeting of the American Association for the Study of Liver Diseases.

Dr. Galbraith, an associate professor of emergency medicine at the University of Alabama, Birmingham, reported on initial results of a screening program funded by the Centers for Disease Control and Prevention that began in September. Results are currently tabulated through Oct. 17. During that time, there were 2,363 unique ED visits by patients born in the years 1945 to 1965. Seventy-three percent (1,721) agreed to answer two questions given by a triage nurse: Have you ever been tested for HCV, and if yes, are you aware of that result? Seventy-five percent, or 1,287 patients, did not know their status and were offered testing.

Alicia Ault/IMNG Medical Media

Of those, 90% (1,148) accepted the antibody test. Patients were excluded from testing if they were medically or surgically unstable, had known HCV infection, or if they chose to opt out.

Antibody tests were performed on 984 of those patients, with results returned to ED physicians within 30-60 minutes. Eighty-eight percent had negative results, but 12%, or 118 patients, were HCV positive.

Researchers attempt to verify positive test results with polymerase chain reaction testing, but it is not always easy to do so, said Dr. Galbraith. Patients must be kept for a new blood draw, and many have already left the ED. Testing is also expensive, he noted.

Overall, men were significantly more likely than were women to test positive (17% compared with 8%). There was no significant difference in HCV positivity rates between whites and African Americans (11% vs. 13%). Patients without insurance or those on Medicaid or other public insurance plans were significantly more likely to be positive, with 17% in each of those groups exhibiting reactivity on the antibody assay, compared with 5% of insured patients.

When patients are determined to be HCV positive, ED physicians counsel and direct them to resources in the community, including specialists. Dr. Galbraith said that the numbers of baby boomers being found to be HCV positive are likely to overwhelm the available specialists.

By September 2014, Dr. Galbraith said, his ED is likely to screen 8,000 baby boomers. If the prevalence rate remains stable, that would mean 864 who are HCV positive and more than 600 with confirmed infection, he said.

Still, it’s important to screen, said Dr. Galbraith, adding that given the study results, "the implication is that the ED may be an important venue for HCV screening."

Two federal entities have called for increased screening. In May, the CDC urged HCV testing for all Americans born between 1945 and 1965.

The U.S. Preventive Services Task Force followed in June, recommending routine HCV screening for high risk Americans, and one-time screening for adults born between 1945 and 1965.

The study was funded by the Centers for Disease Control and Prevention. Dr. Galbraith reported no disclosures.

[email protected]

On Twitter @aliciaault

WASHINGTON – Testifying before a House committee, Health and Human Services Secretary Kathleen Sebelius said that she is accountable for the failures of the healthcare.gov website.

"In these early weeks, access to healthcare.gov has been a miserably frustrating experience for way too many Americans," Ms. Sebelius said at an Oct. 30 hearing of the House Energy and Commerce Committee. "I’m as frustrated and angry as anyone with the flawed launch of healthcare.gov."

Ms. Sebelius apologized and said that she wanted Americans to know that "I’m accountable to you for fixing these problems." She added that she was "committed to earning your confidence back by fixing the site."

It was the second consecutive day that an Obama administration official fielded tough questions from Congress on the problems with healthcare.gov, the main avenue for Americans in 36 states to shop for and enroll in health plans offered under the Affordable Care Act’s (ACA’s) insurance exchanges.

When asked by Rep. Marsha Blackburn (R-Tenn.) who was "responsible for this debacle" surrounding healthcare.gov, Ms. Sebelius said, "Hold me accountable for the debacle. I’m responsible."

When asked whether anyone had suggested delaying the site’s Oct. 1 launch, Ms. Sebelius said that neither officials from the Centers for Medicare and Medicaid Services (CMS) nor information technology contractors had given such advice.

The Health and Human Services (HHS) secretary also refused repeatedly to state how many Americans have enrolled in a plan through the website – or by phone or in person – claiming there is no reliable or confirmed data yet.

"The system isn’t functioning, so we are not getting that reliable data," she said, adding that good numbers will be available in mid-November. HHS has spent $118 million on healthcare.gov and $56 million on "other IT" to support the website, Ms. Sebelius said.

Republicans in Congress also questioned Ms. Sebelius about the insurance cancellation notices that thousands of Americans have received since Oct. 1.

"Americans are scared and frustrated," said Energy and Commerce Committee Chairman Fred Upton (R-Mich.). "There are also millions of Americans coast to coast who no doubt believed the president’s repeated promise that if they liked their plan, they’d be able to keep it, no matter what. They are now receiving termination notices, and for those who lose the coverage they like, they may also be losing faith in their government."

Ms. Sebelius said insurers were cancelling policies in the individual market because the plans did not meet ACA criteria.

Rep. Frank Pallone (D-N.J.) called the cancellation issue "another red herring." He said the real explanation is that "insurance companies are cancelling lousy policies with high prices because they can’t compete."

Rep. Michael Burgess (R-Tex.) said he believed that administration officials had misled the committee and asked if Ms. Sebelius would seek the resignation of Gary Cohen, director of the Center for Consumer Information and Insurance Oversight at the CMS. Mr. Cohen’s office oversees the exchanges.

"I will not, sir," Ms. Sebelius responded.

[email protected]

On Twitter @aliciaault

WASHINGTON – Testifying before a House committee, Health and Human Services Secretary Kathleen Sebelius said that she is accountable for the failures of the healthcare.gov website.

"In these early weeks, access to healthcare.gov has been a miserably frustrating experience for way too many Americans," Ms. Sebelius said at an Oct. 30 hearing of the House Energy and Commerce Committee. "I’m as frustrated and angry as anyone with the flawed launch of healthcare.gov."

Ms. Sebelius apologized and said that she wanted Americans to know that "I’m accountable to you for fixing these problems." She added that she was "committed to earning your confidence back by fixing the site."

It was the second consecutive day that an Obama administration official fielded tough questions from Congress on the problems with healthcare.gov, the main avenue for Americans in 36 states to shop for and enroll in health plans offered under the Affordable Care Act’s (ACA’s) insurance exchanges.

When asked by Rep. Marsha Blackburn (R-Tenn.) who was "responsible for this debacle" surrounding healthcare.gov, Ms. Sebelius said, "Hold me accountable for the debacle. I’m responsible."

When asked whether anyone had suggested delaying the site’s Oct. 1 launch, Ms. Sebelius said that neither officials from the Centers for Medicare and Medicaid Services (CMS) nor information technology contractors had given such advice.

The Health and Human Services (HHS) secretary also refused repeatedly to state how many Americans have enrolled in a plan through the website – or by phone or in person – claiming there is no reliable or confirmed data yet.

"The system isn’t functioning, so we are not getting that reliable data," she said, adding that good numbers will be available in mid-November. HHS has spent $118 million on healthcare.gov and $56 million on "other IT" to support the website, Ms. Sebelius said.

Republicans in Congress also questioned Ms. Sebelius about the insurance cancellation notices that thousands of Americans have received since Oct. 1.

"Americans are scared and frustrated," said Energy and Commerce Committee Chairman Fred Upton (R-Mich.). "There are also millions of Americans coast to coast who no doubt believed the president’s repeated promise that if they liked their plan, they’d be able to keep it, no matter what. They are now receiving termination notices, and for those who lose the coverage they like, they may also be losing faith in their government."

Ms. Sebelius said insurers were cancelling policies in the individual market because the plans did not meet ACA criteria.

Rep. Frank Pallone (D-N.J.) called the cancellation issue "another red herring." He said the real explanation is that "insurance companies are cancelling lousy policies with high prices because they can’t compete."

Rep. Michael Burgess (R-Tex.) said he believed that administration officials had misled the committee and asked if Ms. Sebelius would seek the resignation of Gary Cohen, director of the Center for Consumer Information and Insurance Oversight at the CMS. Mr. Cohen’s office oversees the exchanges.

"I will not, sir," Ms. Sebelius responded.

[email protected]

On Twitter @aliciaault

WASHINGTON – Testifying before a House committee, Health and Human Services Secretary Kathleen Sebelius said that she is accountable for the failures of the healthcare.gov website.

"In these early weeks, access to healthcare.gov has been a miserably frustrating experience for way too many Americans," Ms. Sebelius said at an Oct. 30 hearing of the House Energy and Commerce Committee. "I’m as frustrated and angry as anyone with the flawed launch of healthcare.gov."

Ms. Sebelius apologized and said that she wanted Americans to know that "I’m accountable to you for fixing these problems." She added that she was "committed to earning your confidence back by fixing the site."

It was the second consecutive day that an Obama administration official fielded tough questions from Congress on the problems with healthcare.gov, the main avenue for Americans in 36 states to shop for and enroll in health plans offered under the Affordable Care Act’s (ACA’s) insurance exchanges.

When asked by Rep. Marsha Blackburn (R-Tenn.) who was "responsible for this debacle" surrounding healthcare.gov, Ms. Sebelius said, "Hold me accountable for the debacle. I’m responsible."

When asked whether anyone had suggested delaying the site’s Oct. 1 launch, Ms. Sebelius said that neither officials from the Centers for Medicare and Medicaid Services (CMS) nor information technology contractors had given such advice.

The Health and Human Services (HHS) secretary also refused repeatedly to state how many Americans have enrolled in a plan through the website – or by phone or in person – claiming there is no reliable or confirmed data yet.

"The system isn’t functioning, so we are not getting that reliable data," she said, adding that good numbers will be available in mid-November. HHS has spent $118 million on healthcare.gov and $56 million on "other IT" to support the website, Ms. Sebelius said.

Republicans in Congress also questioned Ms. Sebelius about the insurance cancellation notices that thousands of Americans have received since Oct. 1.

"Americans are scared and frustrated," said Energy and Commerce Committee Chairman Fred Upton (R-Mich.). "There are also millions of Americans coast to coast who no doubt believed the president’s repeated promise that if they liked their plan, they’d be able to keep it, no matter what. They are now receiving termination notices, and for those who lose the coverage they like, they may also be losing faith in their government."

Ms. Sebelius said insurers were cancelling policies in the individual market because the plans did not meet ACA criteria.

Rep. Frank Pallone (D-N.J.) called the cancellation issue "another red herring." He said the real explanation is that "insurance companies are cancelling lousy policies with high prices because they can’t compete."

Rep. Michael Burgess (R-Tex.) said he believed that administration officials had misled the committee and asked if Ms. Sebelius would seek the resignation of Gary Cohen, director of the Center for Consumer Information and Insurance Oversight at the CMS. Mr. Cohen’s office oversees the exchanges.

"I will not, sir," Ms. Sebelius responded.

[email protected]

On Twitter @aliciaault

WASHINGTON – Appearing before a House committee, Medicare Chief Marilyn Tavenner apologized for the problems Americans are experiencing with healthcare.gov.

Thirty-six states are using the federal health insurance exchange, which relies on healthcare.gov as the main avenue for shopping and enrolling in the health insurance made available under the Affordable Care Act. The website has been plagued by glitches since it went live on Oct. 1. Ms. Tavenner, administrator of the Centers for Medicare and Medicaid Services (CMS), is the first administration official to appear before Congress to discuss the rollout of the exchanges.

Alicia Ault/IMNG Medical Media

"To the millions of Americans who’ve attempted to use healthcare.gov to shop and enroll in health care coverage, I want to apologize to you that the website has not worked as well as it should," Ms. Tavenner said at an Oct. 29 hearing of the House Ways and Means Committee. "I want to assure you that healthcare.gov can and will be fixed."

Committee Chairman Dave Camp (R-Mich.) said that "three years should have been enough" time to make sure the website functioned properly, and that the website problems were small compared to overall issues with the ACA [Affordable Care Act]. He said that it appeared that many thousands of Americans were being dropped by their current plans – more, apparently, than were getting signed up for new coverage.

"The numbers I’m hearing from insurers in my home state of Michigan are not good," said Rep. Camp, referring to how many had enrolled in coverage through the exchange there, which is being run in partnership with the state. "In fact, I think I could have a meeting in my office and have all of them fit in it."

When asked by Rep. Camp and other Republicans for details on the numbers of people who have actually enrolled in health insurance via the federal exchange, Ms. Tavenner repeatedly said that those figures would be available in mid-November.

Rep. Camp expressed concerns that given the website problems, it seemed unlikely that the administration would be able to enroll 7 million Americans by late March, and more importantly, to attract large numbers of young and healthy enrollees. Without them, the exchange plans might end up being overly populated with higher-risk, sicker enrollees, he said.

Ms. Tavenner said that premiums were "locked in" for 2014, but that "obviously, the next 6 months of enrollment are critical."

Ways and Means Committee Democrats largely defended the law and said the website would be fixed soon enough. But some were not as quick to apologize for the failures. Rep. Lloyd Doggett (D-Tex.) said that while Republican delaying tactics might be harmful, "I recognize that the promise of affordable health care could also be denied through management failure."

He asked Ms. Tavenner whether both the small business exchanges and a Spanish-language version of healthcare.gov would be up and running by November. She said they would.

Ms. Tavenner emphasized that the system is working. "It’s just not working at the speed that we want and at the success rate that we wanted."

At a press briefing the same day, Julie Bataille, a CMS spokeswoman, said the agency had stabilized the problems that consumers were previously having creating accounts on healthcare.gov. After doubling the number of servers and making software enhancements, the agency is now able to process nearly 17,000 registrants per hour through the account creation step with few errors, she said.

[email protected] On Twitter @aliciaault

WASHINGTON – Appearing before a House committee, Medicare Chief Marilyn Tavenner apologized for the problems Americans are experiencing with healthcare.gov.

Thirty-six states are using the federal health insurance exchange, which relies on healthcare.gov as the main avenue for shopping and enrolling in the health insurance made available under the Affordable Care Act. The website has been plagued by glitches since it went live on Oct. 1. Ms. Tavenner, administrator of the Centers for Medicare and Medicaid Services (CMS), is the first administration official to appear before Congress to discuss the rollout of the exchanges.

Alicia Ault/IMNG Medical Media

"To the millions of Americans who’ve attempted to use healthcare.gov to shop and enroll in health care coverage, I want to apologize to you that the website has not worked as well as it should," Ms. Tavenner said at an Oct. 29 hearing of the House Ways and Means Committee. "I want to assure you that healthcare.gov can and will be fixed."

Committee Chairman Dave Camp (R-Mich.) said that "three years should have been enough" time to make sure the website functioned properly, and that the website problems were small compared to overall issues with the ACA [Affordable Care Act]. He said that it appeared that many thousands of Americans were being dropped by their current plans – more, apparently, than were getting signed up for new coverage.

"The numbers I’m hearing from insurers in my home state of Michigan are not good," said Rep. Camp, referring to how many had enrolled in coverage through the exchange there, which is being run in partnership with the state. "In fact, I think I could have a meeting in my office and have all of them fit in it."

When asked by Rep. Camp and other Republicans for details on the numbers of people who have actually enrolled in health insurance via the federal exchange, Ms. Tavenner repeatedly said that those figures would be available in mid-November.

Rep. Camp expressed concerns that given the website problems, it seemed unlikely that the administration would be able to enroll 7 million Americans by late March, and more importantly, to attract large numbers of young and healthy enrollees. Without them, the exchange plans might end up being overly populated with higher-risk, sicker enrollees, he said.

Ms. Tavenner said that premiums were "locked in" for 2014, but that "obviously, the next 6 months of enrollment are critical."

Ways and Means Committee Democrats largely defended the law and said the website would be fixed soon enough. But some were not as quick to apologize for the failures. Rep. Lloyd Doggett (D-Tex.) said that while Republican delaying tactics might be harmful, "I recognize that the promise of affordable health care could also be denied through management failure."

He asked Ms. Tavenner whether both the small business exchanges and a Spanish-language version of healthcare.gov would be up and running by November. She said they would.

Ms. Tavenner emphasized that the system is working. "It’s just not working at the speed that we want and at the success rate that we wanted."

At a press briefing the same day, Julie Bataille, a CMS spokeswoman, said the agency had stabilized the problems that consumers were previously having creating accounts on healthcare.gov. After doubling the number of servers and making software enhancements, the agency is now able to process nearly 17,000 registrants per hour through the account creation step with few errors, she said.

[email protected] On Twitter @aliciaault

WASHINGTON – Appearing before a House committee, Medicare Chief Marilyn Tavenner apologized for the problems Americans are experiencing with healthcare.gov.

Thirty-six states are using the federal health insurance exchange, which relies on healthcare.gov as the main avenue for shopping and enrolling in the health insurance made available under the Affordable Care Act. The website has been plagued by glitches since it went live on Oct. 1. Ms. Tavenner, administrator of the Centers for Medicare and Medicaid Services (CMS), is the first administration official to appear before Congress to discuss the rollout of the exchanges.

Alicia Ault/IMNG Medical Media

"To the millions of Americans who’ve attempted to use healthcare.gov to shop and enroll in health care coverage, I want to apologize to you that the website has not worked as well as it should," Ms. Tavenner said at an Oct. 29 hearing of the House Ways and Means Committee. "I want to assure you that healthcare.gov can and will be fixed."

Committee Chairman Dave Camp (R-Mich.) said that "three years should have been enough" time to make sure the website functioned properly, and that the website problems were small compared to overall issues with the ACA [Affordable Care Act]. He said that it appeared that many thousands of Americans were being dropped by their current plans – more, apparently, than were getting signed up for new coverage.

"The numbers I’m hearing from insurers in my home state of Michigan are not good," said Rep. Camp, referring to how many had enrolled in coverage through the exchange there, which is being run in partnership with the state. "In fact, I think I could have a meeting in my office and have all of them fit in it."

When asked by Rep. Camp and other Republicans for details on the numbers of people who have actually enrolled in health insurance via the federal exchange, Ms. Tavenner repeatedly said that those figures would be available in mid-November.

Rep. Camp expressed concerns that given the website problems, it seemed unlikely that the administration would be able to enroll 7 million Americans by late March, and more importantly, to attract large numbers of young and healthy enrollees. Without them, the exchange plans might end up being overly populated with higher-risk, sicker enrollees, he said.

Ms. Tavenner said that premiums were "locked in" for 2014, but that "obviously, the next 6 months of enrollment are critical."

Ways and Means Committee Democrats largely defended the law and said the website would be fixed soon enough. But some were not as quick to apologize for the failures. Rep. Lloyd Doggett (D-Tex.) said that while Republican delaying tactics might be harmful, "I recognize that the promise of affordable health care could also be denied through management failure."

He asked Ms. Tavenner whether both the small business exchanges and a Spanish-language version of healthcare.gov would be up and running by November. She said they would.

Ms. Tavenner emphasized that the system is working. "It’s just not working at the speed that we want and at the success rate that we wanted."

At a press briefing the same day, Julie Bataille, a CMS spokeswoman, said the agency had stabilized the problems that consumers were previously having creating accounts on healthcare.gov. After doubling the number of servers and making software enhancements, the agency is now able to process nearly 17,000 registrants per hour through the account creation step with few errors, she said.

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