MEDCAC Meeting

Evidence is insufficient to support lung cancer screening with low-dose computed tomography in the Medicare population, members of the Medicare Evidence Development and Coverage Advisory Committee said at a meeting on April 30.

Specifically, the MEDCAC advisers said that, on average, they had low confidence there is adequate evidence that the benefits outweigh the harms of lung cancer screening with low-dose computed tomography (LDCT) in the Medicare population.

The Centers for Medicare & Medicaid Services accepted two formal requests to initiate a national coverage analysis on lung cancer screening with LDCT, which the U.S. Preventive Services Task Force gave a grade B recommendation for people at high risk for lung cancer based on age and smoking history.

"I think it’s almost impossible to extrapolate to the Medicare population the expected results that we would get when I feel it’s our obligation to first do no harm. I didn’t hear that the evidence is there to support benefit beyond harm," said Dr. Curtis Mock, national medical director of UnitedHealthcare Medicare & Retirement.

Most of the MEDCAC advisers said that they were not satisfied by the Medicare-population data in the National Lung Screening Trial (NLST). That study of more than 50,000 asymptomatic adults, aged 55-74 years, showed a 16% reduction in lung cancer mortality and a 6.7% reduction in all-cause mortality when patients were screened using LDCT (N. Engl. J. Med. 2013;368:1980-91). One cancer death was averted for every 320 patients screened, and one death from all causes was prevented in every 219 patients screened.

But Medicare-eligible patients – those aged 65-74 years – represented about 25% of patients in the trial, less than the nearly 36% NLST-eligible in the U.S. population.

"I am concerned that we don’t really have a lot of data in the Medicare population, certainly not in the 75-80 [year-old age group], particularly on the harms in the age group that was included in NLST," said Dr. Rita Redberg, MEDCAC chair and professor of medicine at the University of California, San Francisco.

Dr. Redberg also highlighted the additional health complications with Medicare-age patients.

"Surgical mortality increases as one gets older, and the benefits of early detection tend to disappear as you get older because there are more competing causes of death," she said.

The MEDCAC advisers also noted that they were not confident that the harms of lung cancer screening with LDCT (average effective dose of 1.5 mSv) would be minimized if implemented in the Medicare population.

"The harm I worry about will be the intervention of this test on people for which we know nothing about the benefits and harms," said Dr. Allan Fendrick, professor in the department of internal medicine at the University of Michigan, Ann Arbor.

Similarly, Dr. Harry Burke, associate professor at the Uniformed Services University of the Health Sciences in Bethesda, Md., said, "I think the low positive predictive value drives harm. Whether you can balance that harm with the benefit is a very difficult business."

Lastly, the advisors said that they strongly believe there are clinically significant evidence gaps when using LDCT for lung cancer screening in the Medicare population outside a clinical trial.

"The most important gap that I see is based on totality of the data – both from this large NLST trial but also high-quality publications from other trials – to be able to come up with a cohort where we would have much higher confidence that the benefits outweigh the harms than other subgroups," said MEDCAC vice chair Dr. Art Sedrakyan, director of the Patient Centered Comparative Outcomes Research Program at Cornell University, New York.

CMS will take the expert panel’s recommendations into consideration as it develops its national coverage decision for lung cancer screening with LDCT, which it plans to issue by mid-November, followed by a 30-day public comment period.

Evidence is insufficient to support lung cancer screening with low-dose computed tomography in the Medicare population, members of the Medicare Evidence Development and Coverage Advisory Committee said at a meeting on April 30.

Specifically, the MEDCAC advisers said that, on average, they had low confidence there is adequate evidence that the benefits outweigh the harms of lung cancer screening with low-dose computed tomography (LDCT) in the Medicare population.

The Centers for Medicare & Medicaid Services accepted two formal requests to initiate a national coverage analysis on lung cancer screening with LDCT, which the U.S. Preventive Services Task Force gave a grade B recommendation for people at high risk for lung cancer based on age and smoking history.

"I think it’s almost impossible to extrapolate to the Medicare population the expected results that we would get when I feel it’s our obligation to first do no harm. I didn’t hear that the evidence is there to support benefit beyond harm," said Dr. Curtis Mock, national medical director of UnitedHealthcare Medicare & Retirement.

Most of the MEDCAC advisers said that they were not satisfied by the Medicare-population data in the National Lung Screening Trial (NLST). That study of more than 50,000 asymptomatic adults, aged 55-74 years, showed a 16% reduction in lung cancer mortality and a 6.7% reduction in all-cause mortality when patients were screened using LDCT (N. Engl. J. Med. 2013;368:1980-91). One cancer death was averted for every 320 patients screened, and one death from all causes was prevented in every 219 patients screened.

But Medicare-eligible patients – those aged 65-74 years – represented about 25% of patients in the trial, less than the nearly 36% NLST-eligible in the U.S. population.

"I am concerned that we don’t really have a lot of data in the Medicare population, certainly not in the 75-80 [year-old age group], particularly on the harms in the age group that was included in NLST," said Dr. Rita Redberg, MEDCAC chair and professor of medicine at the University of California, San Francisco.

Dr. Redberg also highlighted the additional health complications with Medicare-age patients.

"Surgical mortality increases as one gets older, and the benefits of early detection tend to disappear as you get older because there are more competing causes of death," she said.

The MEDCAC advisers also noted that they were not confident that the harms of lung cancer screening with LDCT (average effective dose of 1.5 mSv) would be minimized if implemented in the Medicare population.

"The harm I worry about will be the intervention of this test on people for which we know nothing about the benefits and harms," said Dr. Allan Fendrick, professor in the department of internal medicine at the University of Michigan, Ann Arbor.

Similarly, Dr. Harry Burke, associate professor at the Uniformed Services University of the Health Sciences in Bethesda, Md., said, "I think the low positive predictive value drives harm. Whether you can balance that harm with the benefit is a very difficult business."

Lastly, the advisors said that they strongly believe there are clinically significant evidence gaps when using LDCT for lung cancer screening in the Medicare population outside a clinical trial.

"The most important gap that I see is based on totality of the data – both from this large NLST trial but also high-quality publications from other trials – to be able to come up with a cohort where we would have much higher confidence that the benefits outweigh the harms than other subgroups," said MEDCAC vice chair Dr. Art Sedrakyan, director of the Patient Centered Comparative Outcomes Research Program at Cornell University, New York.

CMS will take the expert panel’s recommendations into consideration as it develops its national coverage decision for lung cancer screening with LDCT, which it plans to issue by mid-November, followed by a 30-day public comment period.

Evidence is insufficient to support lung cancer screening with low-dose computed tomography in the Medicare population, members of the Medicare Evidence Development and Coverage Advisory Committee said at a meeting on April 30.

Specifically, the MEDCAC advisers said that, on average, they had low confidence there is adequate evidence that the benefits outweigh the harms of lung cancer screening with low-dose computed tomography (LDCT) in the Medicare population.

The Centers for Medicare & Medicaid Services accepted two formal requests to initiate a national coverage analysis on lung cancer screening with LDCT, which the U.S. Preventive Services Task Force gave a grade B recommendation for people at high risk for lung cancer based on age and smoking history.

"I think it’s almost impossible to extrapolate to the Medicare population the expected results that we would get when I feel it’s our obligation to first do no harm. I didn’t hear that the evidence is there to support benefit beyond harm," said Dr. Curtis Mock, national medical director of UnitedHealthcare Medicare & Retirement.

Most of the MEDCAC advisers said that they were not satisfied by the Medicare-population data in the National Lung Screening Trial (NLST). That study of more than 50,000 asymptomatic adults, aged 55-74 years, showed a 16% reduction in lung cancer mortality and a 6.7% reduction in all-cause mortality when patients were screened using LDCT (N. Engl. J. Med. 2013;368:1980-91). One cancer death was averted for every 320 patients screened, and one death from all causes was prevented in every 219 patients screened.

But Medicare-eligible patients – those aged 65-74 years – represented about 25% of patients in the trial, less than the nearly 36% NLST-eligible in the U.S. population.

"I am concerned that we don’t really have a lot of data in the Medicare population, certainly not in the 75-80 [year-old age group], particularly on the harms in the age group that was included in NLST," said Dr. Rita Redberg, MEDCAC chair and professor of medicine at the University of California, San Francisco.

Dr. Redberg also highlighted the additional health complications with Medicare-age patients.

"Surgical mortality increases as one gets older, and the benefits of early detection tend to disappear as you get older because there are more competing causes of death," she said.

The MEDCAC advisers also noted that they were not confident that the harms of lung cancer screening with LDCT (average effective dose of 1.5 mSv) would be minimized if implemented in the Medicare population.

"The harm I worry about will be the intervention of this test on people for which we know nothing about the benefits and harms," said Dr. Allan Fendrick, professor in the department of internal medicine at the University of Michigan, Ann Arbor.

Similarly, Dr. Harry Burke, associate professor at the Uniformed Services University of the Health Sciences in Bethesda, Md., said, "I think the low positive predictive value drives harm. Whether you can balance that harm with the benefit is a very difficult business."

Lastly, the advisors said that they strongly believe there are clinically significant evidence gaps when using LDCT for lung cancer screening in the Medicare population outside a clinical trial.

"The most important gap that I see is based on totality of the data – both from this large NLST trial but also high-quality publications from other trials – to be able to come up with a cohort where we would have much higher confidence that the benefits outweigh the harms than other subgroups," said MEDCAC vice chair Dr. Art Sedrakyan, director of the Patient Centered Comparative Outcomes Research Program at Cornell University, New York.

CMS will take the expert panel’s recommendations into consideration as it develops its national coverage decision for lung cancer screening with LDCT, which it plans to issue by mid-November, followed by a 30-day public comment period.

Should Medicare pay for low-dose computed tomography to screen certain patients for lung cancer? A panel of expert advisers will meet April 30 to review the evidence and make a recommendation.

The Centers for Medicare & Medicaid Services has accepted two formal requests to initiate a national coverage analysis on lung cancer screening with low-dose computed tomography (LDCT), which the U.S. Preventative Services Task Force gave a grade B recommendation for people at high risk for lung cancer based on age and smoking history.

©Valeriy Kirsanov/fotolia.com

CMS is specifically asking its Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) to discuss:

• the evidence that identifies which Medicare patients would benefit the most from the screening.

• screening frequency and duration.

• provider characteristics that optimize benefits and minimize harm.

• criteria to identify a test as positive and the impact of false-positive results.

• follow-up tests or treatments.

The agency also seeks to know how these factors will impact patient education and informed consent in Medicare beneficiaries, including the elderly, younger disabled populations, and patients with end-stage renal disease, and on integrating smoking cessation interventions for current smokers.

In order for CMS to issue a national coverage determination for a preventive service, the following criteria must be met: reasonable and necessary for prevention or early detection of an illness or disability; an A- or B-grade recommendation from USPSTF; and appropriate for Medicare Part A or Medicare Part B beneficiaries.

CMS has asked the panel to vote on whether there is adequate evidence to determine if the benefits of lung cancer screening with LDCT outweigh the harms. The agency will specifically ask if there is adequate evidence to determine if LDCT improves health outcomes: in asymptomatic, high-risk adults over 74 years old; with more than three annual LDCT screens; and if the screening program is implemented outside a clinical study.

The agency is also asking for panel input on the harms of lung cancer screening with LDCT in the Medicare population, specifically harms from the scan itself (an average dose of 1.5 mSv), harms from follow-up evaluation of findings in and outside the lungs, and harms from treatment as a result of positive and false-positive results.

CMS will also ask the panel to identify and discuss any clinically significant evidence gaps regarding the use of LDCT in lung cancer screening outside of a clinical trial.

Last December, the USPSTF recommended annual screening for lung cancer with LDCT in adults aged 55- 80 years who have a 30-pack-year smoking history and currently smoke or have quit in the past 15 years. The recommendation states that screening should be stopped once a person has stopped smoking for 15 years or develops a health problem limiting life expectancy or the ability to have curative lung surgery.

The USPSTF’s recommendations were based largely on a systematic review of several randomized, controlled trials published between 2000 and 2013, including the National Lung Screening Trial. That study of more than 50,000 asymptomatic adults, aged 55-74 years, showed a 16% reduction in lung cancer mortality and a 6.7% reduction in all-cause mortality when patients were screened using LDCT. One cancer death was averted for every 320 patients screened, and one death from all causes was prevented in every 219 patients screened.

Under the Affordable Care Act, insurers are required to cover, with no copay requirements, preventative care and screening services that receive a grade A or grade B recommendation from USPSTF.

Should Medicare pay for low-dose computed tomography to screen certain patients for lung cancer? A panel of expert advisers will meet April 30 to review the evidence and make a recommendation.

The Centers for Medicare & Medicaid Services has accepted two formal requests to initiate a national coverage analysis on lung cancer screening with low-dose computed tomography (LDCT), which the U.S. Preventative Services Task Force gave a grade B recommendation for people at high risk for lung cancer based on age and smoking history.

©Valeriy Kirsanov/fotolia.com

CMS is specifically asking its Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) to discuss:

• the evidence that identifies which Medicare patients would benefit the most from the screening.

• screening frequency and duration.

• provider characteristics that optimize benefits and minimize harm.

• criteria to identify a test as positive and the impact of false-positive results.

• follow-up tests or treatments.

The agency also seeks to know how these factors will impact patient education and informed consent in Medicare beneficiaries, including the elderly, younger disabled populations, and patients with end-stage renal disease, and on integrating smoking cessation interventions for current smokers.

In order for CMS to issue a national coverage determination for a preventive service, the following criteria must be met: reasonable and necessary for prevention or early detection of an illness or disability; an A- or B-grade recommendation from USPSTF; and appropriate for Medicare Part A or Medicare Part B beneficiaries.

CMS has asked the panel to vote on whether there is adequate evidence to determine if the benefits of lung cancer screening with LDCT outweigh the harms. The agency will specifically ask if there is adequate evidence to determine if LDCT improves health outcomes: in asymptomatic, high-risk adults over 74 years old; with more than three annual LDCT screens; and if the screening program is implemented outside a clinical study.

The agency is also asking for panel input on the harms of lung cancer screening with LDCT in the Medicare population, specifically harms from the scan itself (an average dose of 1.5 mSv), harms from follow-up evaluation of findings in and outside the lungs, and harms from treatment as a result of positive and false-positive results.

CMS will also ask the panel to identify and discuss any clinically significant evidence gaps regarding the use of LDCT in lung cancer screening outside of a clinical trial.

Last December, the USPSTF recommended annual screening for lung cancer with LDCT in adults aged 55- 80 years who have a 30-pack-year smoking history and currently smoke or have quit in the past 15 years. The recommendation states that screening should be stopped once a person has stopped smoking for 15 years or develops a health problem limiting life expectancy or the ability to have curative lung surgery.

The USPSTF’s recommendations were based largely on a systematic review of several randomized, controlled trials published between 2000 and 2013, including the National Lung Screening Trial. That study of more than 50,000 asymptomatic adults, aged 55-74 years, showed a 16% reduction in lung cancer mortality and a 6.7% reduction in all-cause mortality when patients were screened using LDCT. One cancer death was averted for every 320 patients screened, and one death from all causes was prevented in every 219 patients screened.

Under the Affordable Care Act, insurers are required to cover, with no copay requirements, preventative care and screening services that receive a grade A or grade B recommendation from USPSTF.

Should Medicare pay for low-dose computed tomography to screen certain patients for lung cancer? A panel of expert advisers will meet April 30 to review the evidence and make a recommendation.

The Centers for Medicare & Medicaid Services has accepted two formal requests to initiate a national coverage analysis on lung cancer screening with low-dose computed tomography (LDCT), which the U.S. Preventative Services Task Force gave a grade B recommendation for people at high risk for lung cancer based on age and smoking history.

©Valeriy Kirsanov/fotolia.com

CMS is specifically asking its Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) to discuss:

• the evidence that identifies which Medicare patients would benefit the most from the screening.

• screening frequency and duration.

• provider characteristics that optimize benefits and minimize harm.

• criteria to identify a test as positive and the impact of false-positive results.

• follow-up tests or treatments.

The agency also seeks to know how these factors will impact patient education and informed consent in Medicare beneficiaries, including the elderly, younger disabled populations, and patients with end-stage renal disease, and on integrating smoking cessation interventions for current smokers.

In order for CMS to issue a national coverage determination for a preventive service, the following criteria must be met: reasonable and necessary for prevention or early detection of an illness or disability; an A- or B-grade recommendation from USPSTF; and appropriate for Medicare Part A or Medicare Part B beneficiaries.

CMS has asked the panel to vote on whether there is adequate evidence to determine if the benefits of lung cancer screening with LDCT outweigh the harms. The agency will specifically ask if there is adequate evidence to determine if LDCT improves health outcomes: in asymptomatic, high-risk adults over 74 years old; with more than three annual LDCT screens; and if the screening program is implemented outside a clinical study.

The agency is also asking for panel input on the harms of lung cancer screening with LDCT in the Medicare population, specifically harms from the scan itself (an average dose of 1.5 mSv), harms from follow-up evaluation of findings in and outside the lungs, and harms from treatment as a result of positive and false-positive results.

CMS will also ask the panel to identify and discuss any clinically significant evidence gaps regarding the use of LDCT in lung cancer screening outside of a clinical trial.

Last December, the USPSTF recommended annual screening for lung cancer with LDCT in adults aged 55- 80 years who have a 30-pack-year smoking history and currently smoke or have quit in the past 15 years. The recommendation states that screening should be stopped once a person has stopped smoking for 15 years or develops a health problem limiting life expectancy or the ability to have curative lung surgery.

The USPSTF’s recommendations were based largely on a systematic review of several randomized, controlled trials published between 2000 and 2013, including the National Lung Screening Trial. That study of more than 50,000 asymptomatic adults, aged 55-74 years, showed a 16% reduction in lung cancer mortality and a 6.7% reduction in all-cause mortality when patients were screened using LDCT. One cancer death was averted for every 320 patients screened, and one death from all causes was prevented in every 219 patients screened.

Under the Affordable Care Act, insurers are required to cover, with no copay requirements, preventative care and screening services that receive a grade A or grade B recommendation from USPSTF.