Gregory Twachtman

A multiple sclerosis patient being treated with dimethyl fumarate developed progressive multifocal leukoencephalopathy and later died, prompting an update that will be added to the drug’s label detailing the case, the Food and Drug Administration said.

The agency said in a Nov. 25 alert that the patient “was not taking any other drugs that affect the immune system or drugs that are thought to be associated with PML [progressive multifocal leukoencephalopathy],” a rare and serious brain infection caused by the John Cunningham (JC) virus, a common virus that is generally harmless but can cause PML in those with weakened immune systems.

Dimethyl fumarate is used to treat relapsing forms of MS. Biogen Idec, which manufactures the drug under the brand name Tecfidera, alerted the FDA of the patient death, noting that the patient had been taking Tecfidera for more than 4 years and that she had a very low number of lymphocytes prior to developing PML.

The agency is recommending that health care professionals tell patients to contact them if they develop any symptoms of PML, including progressive weakness on one side of the body or clumsiness of limbs; disturbance of vision; and changes in thinking, memory, and orientation, leading to confusion and personality changes. The progression can lead to severe disability or death. Physicians should monitor lymphocyte counts in patients taking dimethyl fumarate, according to the approved label.

Patients should stop taking dimethyl fumarate immediately at the first sign or symptom suggestive of PML, the FDA said.

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A multiple sclerosis patient being treated with dimethyl fumarate developed progressive multifocal leukoencephalopathy and later died, prompting an update that will be added to the drug’s label detailing the case, the Food and Drug Administration said.

The agency said in a Nov. 25 alert that the patient “was not taking any other drugs that affect the immune system or drugs that are thought to be associated with PML [progressive multifocal leukoencephalopathy],” a rare and serious brain infection caused by the John Cunningham (JC) virus, a common virus that is generally harmless but can cause PML in those with weakened immune systems.

Dimethyl fumarate is used to treat relapsing forms of MS. Biogen Idec, which manufactures the drug under the brand name Tecfidera, alerted the FDA of the patient death, noting that the patient had been taking Tecfidera for more than 4 years and that she had a very low number of lymphocytes prior to developing PML.

The agency is recommending that health care professionals tell patients to contact them if they develop any symptoms of PML, including progressive weakness on one side of the body or clumsiness of limbs; disturbance of vision; and changes in thinking, memory, and orientation, leading to confusion and personality changes. The progression can lead to severe disability or death. Physicians should monitor lymphocyte counts in patients taking dimethyl fumarate, according to the approved label.

Patients should stop taking dimethyl fumarate immediately at the first sign or symptom suggestive of PML, the FDA said.

[email protected]

A multiple sclerosis patient being treated with dimethyl fumarate developed progressive multifocal leukoencephalopathy and later died, prompting an update that will be added to the drug’s label detailing the case, the Food and Drug Administration said.

The agency said in a Nov. 25 alert that the patient “was not taking any other drugs that affect the immune system or drugs that are thought to be associated with PML [progressive multifocal leukoencephalopathy],” a rare and serious brain infection caused by the John Cunningham (JC) virus, a common virus that is generally harmless but can cause PML in those with weakened immune systems.

Dimethyl fumarate is used to treat relapsing forms of MS. Biogen Idec, which manufactures the drug under the brand name Tecfidera, alerted the FDA of the patient death, noting that the patient had been taking Tecfidera for more than 4 years and that she had a very low number of lymphocytes prior to developing PML.

The agency is recommending that health care professionals tell patients to contact them if they develop any symptoms of PML, including progressive weakness on one side of the body or clumsiness of limbs; disturbance of vision; and changes in thinking, memory, and orientation, leading to confusion and personality changes. The progression can lead to severe disability or death. Physicians should monitor lymphocyte counts in patients taking dimethyl fumarate, according to the approved label.

Patients should stop taking dimethyl fumarate immediately at the first sign or symptom suggestive of PML, the FDA said.

[email protected]

Following the discovery of capsules found to be empty, Aurobindo Pharma USA has initiated a recall of the epilepsy treatment gabapentin, the company announced Nov. 21.

The company is voluntarily recalling lot GESB14011-A of 100-count bottles of 300 mg gabapentin, which have an expiration date of December 2015. The product also is used to manage postherpetic neuralgia.

The Food and Drug Administration noted that the empty capsules could result in missed doses, potentially resulting in no effect, short-term efficacy reduction, short-term withdrawal effect, or status epilepticus that could be life threatening.

[email protected]

Following the discovery of capsules found to be empty, Aurobindo Pharma USA has initiated a recall of the epilepsy treatment gabapentin, the company announced Nov. 21.

The company is voluntarily recalling lot GESB14011-A of 100-count bottles of 300 mg gabapentin, which have an expiration date of December 2015. The product also is used to manage postherpetic neuralgia.

The Food and Drug Administration noted that the empty capsules could result in missed doses, potentially resulting in no effect, short-term efficacy reduction, short-term withdrawal effect, or status epilepticus that could be life threatening.

[email protected]

Following the discovery of capsules found to be empty, Aurobindo Pharma USA has initiated a recall of the epilepsy treatment gabapentin, the company announced Nov. 21.

The company is voluntarily recalling lot GESB14011-A of 100-count bottles of 300 mg gabapentin, which have an expiration date of December 2015. The product also is used to manage postherpetic neuralgia.

The Food and Drug Administration noted that the empty capsules could result in missed doses, potentially resulting in no effect, short-term efficacy reduction, short-term withdrawal effect, or status epilepticus that could be life threatening.

[email protected]

The Obama administration’s request for $6.1 billion to address Ebola in part seeks to lay a better foundation for fighting the current pandemic as well as future ones, federal officials testified before the Senate Appropriations Committee Nov. 12.

Some of the requested funds would be distributed to states to help build local capacity to treat Ebola patients, with a focus on states with a higher probability of having an infected person.

Courtesy HHS

Centers at the University of Nebraska Medical Center, Omaha; Emory University Hospital, Atlanta; and the National Institutes of Health, Bethesda, Md., are ready to handle patients. The next step would be to build capacity near the airports where people traveling from West Africa might arrive – John F. Kennedy International Airport in New York City; Newark (N.J.) Liberty International Airport; Chicago O’Hare International Airport; Dulles (Va.) International Airport; and Hartsfield-Jackson Atlanta International Airport.

“Beyond that, we have been tracking where the actual incoming people are going,” Sylvia Burwell, Health and Human Services secretary testified, with the next area of focus being the communities where people are going after they arrive in the United States.

“Many states have approached us because of their desire to make sure that they have a facility,” Ms. Burwell added, noting that a goal is to be able to transfer a highly infectious patient to an appropriate treatment facility within 8 hours, no matter where the patient is located.

And while the requested funding would help cover the cost of training as well as emergency equipment to address treatment, nothing is specifically earmarked for helping to cover the cost of treatment.

Sen. Mike Johanns (R-Neb.) said that the funding request includes reimbursing the World Health Organization and others for their current efforts to help with the Ebola response, but no money has been put aside to help hospitals in the United States that have already seen patients.

“It seems that at this point, some assistance in terms of reimbursement would be appropriate because treating an Ebola patient is worlds [apart from] treating Mike Johanns who walks in with a severe case of the flu,” he said, questioning just how much private insurance will pay to cover treating an Ebola patient because costs are “through the roof.”

Ms. Burwell responded that to date, those conversations have remained between private insurance and hospitals and “it has not been an issue that has come to us. But if this is something that folks want to discuss as part of this funding, we are happy to entertain that.”

[email protected]

The Obama administration’s request for $6.1 billion to address Ebola in part seeks to lay a better foundation for fighting the current pandemic as well as future ones, federal officials testified before the Senate Appropriations Committee Nov. 12.

Some of the requested funds would be distributed to states to help build local capacity to treat Ebola patients, with a focus on states with a higher probability of having an infected person.

Courtesy HHS

Centers at the University of Nebraska Medical Center, Omaha; Emory University Hospital, Atlanta; and the National Institutes of Health, Bethesda, Md., are ready to handle patients. The next step would be to build capacity near the airports where people traveling from West Africa might arrive – John F. Kennedy International Airport in New York City; Newark (N.J.) Liberty International Airport; Chicago O’Hare International Airport; Dulles (Va.) International Airport; and Hartsfield-Jackson Atlanta International Airport.

“Beyond that, we have been tracking where the actual incoming people are going,” Sylvia Burwell, Health and Human Services secretary testified, with the next area of focus being the communities where people are going after they arrive in the United States.

“Many states have approached us because of their desire to make sure that they have a facility,” Ms. Burwell added, noting that a goal is to be able to transfer a highly infectious patient to an appropriate treatment facility within 8 hours, no matter where the patient is located.

And while the requested funding would help cover the cost of training as well as emergency equipment to address treatment, nothing is specifically earmarked for helping to cover the cost of treatment.

Sen. Mike Johanns (R-Neb.) said that the funding request includes reimbursing the World Health Organization and others for their current efforts to help with the Ebola response, but no money has been put aside to help hospitals in the United States that have already seen patients.

“It seems that at this point, some assistance in terms of reimbursement would be appropriate because treating an Ebola patient is worlds [apart from] treating Mike Johanns who walks in with a severe case of the flu,” he said, questioning just how much private insurance will pay to cover treating an Ebola patient because costs are “through the roof.”

Ms. Burwell responded that to date, those conversations have remained between private insurance and hospitals and “it has not been an issue that has come to us. But if this is something that folks want to discuss as part of this funding, we are happy to entertain that.”

[email protected]

The Obama administration’s request for $6.1 billion to address Ebola in part seeks to lay a better foundation for fighting the current pandemic as well as future ones, federal officials testified before the Senate Appropriations Committee Nov. 12.

Some of the requested funds would be distributed to states to help build local capacity to treat Ebola patients, with a focus on states with a higher probability of having an infected person.

Courtesy HHS

Centers at the University of Nebraska Medical Center, Omaha; Emory University Hospital, Atlanta; and the National Institutes of Health, Bethesda, Md., are ready to handle patients. The next step would be to build capacity near the airports where people traveling from West Africa might arrive – John F. Kennedy International Airport in New York City; Newark (N.J.) Liberty International Airport; Chicago O’Hare International Airport; Dulles (Va.) International Airport; and Hartsfield-Jackson Atlanta International Airport.

“Beyond that, we have been tracking where the actual incoming people are going,” Sylvia Burwell, Health and Human Services secretary testified, with the next area of focus being the communities where people are going after they arrive in the United States.

“Many states have approached us because of their desire to make sure that they have a facility,” Ms. Burwell added, noting that a goal is to be able to transfer a highly infectious patient to an appropriate treatment facility within 8 hours, no matter where the patient is located.

And while the requested funding would help cover the cost of training as well as emergency equipment to address treatment, nothing is specifically earmarked for helping to cover the cost of treatment.

Sen. Mike Johanns (R-Neb.) said that the funding request includes reimbursing the World Health Organization and others for their current efforts to help with the Ebola response, but no money has been put aside to help hospitals in the United States that have already seen patients.

“It seems that at this point, some assistance in terms of reimbursement would be appropriate because treating an Ebola patient is worlds [apart from] treating Mike Johanns who walks in with a severe case of the flu,” he said, questioning just how much private insurance will pay to cover treating an Ebola patient because costs are “through the roof.”

Ms. Burwell responded that to date, those conversations have remained between private insurance and hospitals and “it has not been an issue that has come to us. But if this is something that folks want to discuss as part of this funding, we are happy to entertain that.”

[email protected]

Medicare has announced a proposal to cover low-dose computed tomography screens for patients at high risk for lung cancer.

“The evidence is sufficient to add a lung cancer screening counseling and shared decision making visit, and for appropriate beneficiaries, screening for lung cancer with low-dose computed tomography, once per year, as an additional preventive service benefit under the Medicare program,” officials from the Centers for Medicare & Medicaid Services wrote in the proposed national coverage decision, which was announced Nov. 10.

The proposed coverage decision was made despite the Medicare Evidence Development and Coverage Advisory Commission recommendation earlier this year that opposed covering LDCT screening. More recently, however, a study has found LDCT screening to be cost effective for patients at high risk for lung cancer (N. Engl. J Med. 2014;371:1793-802 [doi:10.1056/NEJMoa1312547]).

Based on the proposal, appropriate candidates for screening would be 55-74 years old, show no signs of lung disease, and have a smoking history of at least 30 pack-years. Further, appropriate patients would be either current smokers or would have quit within the past 15 years.

Another stipulation of the proposal is the requirement for a physician or qualified non-physician practitioner to schedule a visit for counseling and shared decision making with patients before issuing a written order for LDCT screening.

The time requirement and questions about how this counseling would be covered makes the counseling visit “one of the most interesting things in the Medicare requirement,” said Steven Zeliadt, Ph.D., core investigator at VA Health Services Research & Development Services and professor at the University of Washington in Seattle. “That’s very different than other cancer screening tests, and for Medicare to really be encouraging and requiring that is something providers and systems are going to (need to) figure out.”

As a result of the counseling requirement and standards of expectation for centers performing screening LDCT, specialized centers are likely to gain traction and manage the bulk of these patients, Dr. Zeliadt said.

These will be the places that integrate both parts of the screening by conducting the LDCT test as well as providing the counseling. This differs from the model used for colon cancer and prostate cancer screening, where test results are sent to the physician so that he or she can counsel the patient.

Such centers exist now, he noted. “They hire counselors and [conduct] an hour-long pre-screening visit.”

That model doesn’t easily fit into an office-based setting and does not take advantage of the physician/patient relationship, he added. “There is an opportunity for a familiar provider to engage patients around counseling, so (moving the screening to a center) takes away from the long-term relationship,” including knowing more deeply each patient’s risks and history with smoking and attempts to quit.

It also may detract from opportunities to maintain conversations about smoking cessation, and the need to quit as patients may “feel protected by screening.”

CMS is soliticing comments on the proposed national coverage decision until Dec. 10.

The determination of eligibility for LDCT screening will depend on age, absence of signs or symptoms of lung disease, a specific calculation of cigarette smoking pack-years; and if a former smoker, the number of years since quitting. Shared decision making, including the use of one or more decision aids, needs to include the benefits, harms, follow-up diagnostic testing, over-diagnosis, false positive rate, and total radiation exposure.

Counseling must address the importance of adherence to annual LDCT lung cancer screening, the impact of comorbidities, and the ability or willingness to undergo diagnosis and treatment. Also, counseling needs to include the importance of maintaining cigarette smoking abstinence among former smokers and a plan for smoking cessation in current smokers and, if appropriate, offering additional Medicare-covered tobacco cessation counseling services.

Written orders for both initial and subsequent LDCT lung cancer screenings must be documented in the beneficiaries’ medical records and include patient date of birth, pack-year smoking history, and current smoking status or the number of years since quitting smoking. The order must also include a statement that the beneficiary is asymptomatic; and the NPI of the ordering practitioner.

To be eligible to perform the screening, radiologists must be board certified and involved in the supervision and interpretation of at least 300 chest CT acquisitions in the past 3 years.

Medicare-eligible centers for lung cancer LDCT screening must have participated in past lung cancer screening trials, such as the National Lung Screening Trial or be an accredited advanced diagnostic imaging center with training and experience in LDCT lung cancer screening. They must use LDCTs with an effective radiation dose less than 1.5 mSv, and they must collect and submit data to a CMS-approved national registry for each LDCT lung cancer screening performed.

[email protected]

Medicare has announced a proposal to cover low-dose computed tomography screens for patients at high risk for lung cancer.

“The evidence is sufficient to add a lung cancer screening counseling and shared decision making visit, and for appropriate beneficiaries, screening for lung cancer with low-dose computed tomography, once per year, as an additional preventive service benefit under the Medicare program,” officials from the Centers for Medicare & Medicaid Services wrote in the proposed national coverage decision, which was announced Nov. 10.

The proposed coverage decision was made despite the Medicare Evidence Development and Coverage Advisory Commission recommendation earlier this year that opposed covering LDCT screening. More recently, however, a study has found LDCT screening to be cost effective for patients at high risk for lung cancer (N. Engl. J Med. 2014;371:1793-802 [doi:10.1056/NEJMoa1312547]).

Based on the proposal, appropriate candidates for screening would be 55-74 years old, show no signs of lung disease, and have a smoking history of at least 30 pack-years. Further, appropriate patients would be either current smokers or would have quit within the past 15 years.

Another stipulation of the proposal is the requirement for a physician or qualified non-physician practitioner to schedule a visit for counseling and shared decision making with patients before issuing a written order for LDCT screening.

The time requirement and questions about how this counseling would be covered makes the counseling visit “one of the most interesting things in the Medicare requirement,” said Steven Zeliadt, Ph.D., core investigator at VA Health Services Research & Development Services and professor at the University of Washington in Seattle. “That’s very different than other cancer screening tests, and for Medicare to really be encouraging and requiring that is something providers and systems are going to (need to) figure out.”

As a result of the counseling requirement and standards of expectation for centers performing screening LDCT, specialized centers are likely to gain traction and manage the bulk of these patients, Dr. Zeliadt said.

These will be the places that integrate both parts of the screening by conducting the LDCT test as well as providing the counseling. This differs from the model used for colon cancer and prostate cancer screening, where test results are sent to the physician so that he or she can counsel the patient.

Such centers exist now, he noted. “They hire counselors and [conduct] an hour-long pre-screening visit.”

That model doesn’t easily fit into an office-based setting and does not take advantage of the physician/patient relationship, he added. “There is an opportunity for a familiar provider to engage patients around counseling, so (moving the screening to a center) takes away from the long-term relationship,” including knowing more deeply each patient’s risks and history with smoking and attempts to quit.

It also may detract from opportunities to maintain conversations about smoking cessation, and the need to quit as patients may “feel protected by screening.”

CMS is soliticing comments on the proposed national coverage decision until Dec. 10.

The determination of eligibility for LDCT screening will depend on age, absence of signs or symptoms of lung disease, a specific calculation of cigarette smoking pack-years; and if a former smoker, the number of years since quitting. Shared decision making, including the use of one or more decision aids, needs to include the benefits, harms, follow-up diagnostic testing, over-diagnosis, false positive rate, and total radiation exposure.

Counseling must address the importance of adherence to annual LDCT lung cancer screening, the impact of comorbidities, and the ability or willingness to undergo diagnosis and treatment. Also, counseling needs to include the importance of maintaining cigarette smoking abstinence among former smokers and a plan for smoking cessation in current smokers and, if appropriate, offering additional Medicare-covered tobacco cessation counseling services.

Written orders for both initial and subsequent LDCT lung cancer screenings must be documented in the beneficiaries’ medical records and include patient date of birth, pack-year smoking history, and current smoking status or the number of years since quitting smoking. The order must also include a statement that the beneficiary is asymptomatic; and the NPI of the ordering practitioner.

To be eligible to perform the screening, radiologists must be board certified and involved in the supervision and interpretation of at least 300 chest CT acquisitions in the past 3 years.

Medicare-eligible centers for lung cancer LDCT screening must have participated in past lung cancer screening trials, such as the National Lung Screening Trial or be an accredited advanced diagnostic imaging center with training and experience in LDCT lung cancer screening. They must use LDCTs with an effective radiation dose less than 1.5 mSv, and they must collect and submit data to a CMS-approved national registry for each LDCT lung cancer screening performed.

[email protected]

Medicare has announced a proposal to cover low-dose computed tomography screens for patients at high risk for lung cancer.

“The evidence is sufficient to add a lung cancer screening counseling and shared decision making visit, and for appropriate beneficiaries, screening for lung cancer with low-dose computed tomography, once per year, as an additional preventive service benefit under the Medicare program,” officials from the Centers for Medicare & Medicaid Services wrote in the proposed national coverage decision, which was announced Nov. 10.

The proposed coverage decision was made despite the Medicare Evidence Development and Coverage Advisory Commission recommendation earlier this year that opposed covering LDCT screening. More recently, however, a study has found LDCT screening to be cost effective for patients at high risk for lung cancer (N. Engl. J Med. 2014;371:1793-802 [doi:10.1056/NEJMoa1312547]).

Based on the proposal, appropriate candidates for screening would be 55-74 years old, show no signs of lung disease, and have a smoking history of at least 30 pack-years. Further, appropriate patients would be either current smokers or would have quit within the past 15 years.

Another stipulation of the proposal is the requirement for a physician or qualified non-physician practitioner to schedule a visit for counseling and shared decision making with patients before issuing a written order for LDCT screening.

The time requirement and questions about how this counseling would be covered makes the counseling visit “one of the most interesting things in the Medicare requirement,” said Steven Zeliadt, Ph.D., core investigator at VA Health Services Research & Development Services and professor at the University of Washington in Seattle. “That’s very different than other cancer screening tests, and for Medicare to really be encouraging and requiring that is something providers and systems are going to (need to) figure out.”

As a result of the counseling requirement and standards of expectation for centers performing screening LDCT, specialized centers are likely to gain traction and manage the bulk of these patients, Dr. Zeliadt said.

These will be the places that integrate both parts of the screening by conducting the LDCT test as well as providing the counseling. This differs from the model used for colon cancer and prostate cancer screening, where test results are sent to the physician so that he or she can counsel the patient.

Such centers exist now, he noted. “They hire counselors and [conduct] an hour-long pre-screening visit.”

That model doesn’t easily fit into an office-based setting and does not take advantage of the physician/patient relationship, he added. “There is an opportunity for a familiar provider to engage patients around counseling, so (moving the screening to a center) takes away from the long-term relationship,” including knowing more deeply each patient’s risks and history with smoking and attempts to quit.

It also may detract from opportunities to maintain conversations about smoking cessation, and the need to quit as patients may “feel protected by screening.”

CMS is soliticing comments on the proposed national coverage decision until Dec. 10.

The determination of eligibility for LDCT screening will depend on age, absence of signs or symptoms of lung disease, a specific calculation of cigarette smoking pack-years; and if a former smoker, the number of years since quitting. Shared decision making, including the use of one or more decision aids, needs to include the benefits, harms, follow-up diagnostic testing, over-diagnosis, false positive rate, and total radiation exposure.

Counseling must address the importance of adherence to annual LDCT lung cancer screening, the impact of comorbidities, and the ability or willingness to undergo diagnosis and treatment. Also, counseling needs to include the importance of maintaining cigarette smoking abstinence among former smokers and a plan for smoking cessation in current smokers and, if appropriate, offering additional Medicare-covered tobacco cessation counseling services.

Written orders for both initial and subsequent LDCT lung cancer screenings must be documented in the beneficiaries’ medical records and include patient date of birth, pack-year smoking history, and current smoking status or the number of years since quitting smoking. The order must also include a statement that the beneficiary is asymptomatic; and the NPI of the ordering practitioner.

To be eligible to perform the screening, radiologists must be board certified and involved in the supervision and interpretation of at least 300 chest CT acquisitions in the past 3 years.

Medicare-eligible centers for lung cancer LDCT screening must have participated in past lung cancer screening trials, such as the National Lung Screening Trial or be an accredited advanced diagnostic imaging center with training and experience in LDCT lung cancer screening. They must use LDCTs with an effective radiation dose less than 1.5 mSv, and they must collect and submit data to a CMS-approved national registry for each LDCT lung cancer screening performed.

[email protected]

A counseling requirement included in Medicare’s proposed decision to cover screening for lung cancer with low-dose computed tomography could pull primary care physicians out of the decision loop.

The proposed national coverage decision from the Centers for Medicare & Medicaid Services, announced Nov. 10, includes a requirement that patients “receive a written order for [low-dose computed tomography screening] during a lung cancer screening counseling and shared decision making visit, furnished by a physician ... or qualified nonphysician practitioner.” CMS has proposed covering low-dose computed tomography (LDCT) screening only for certain high-risk patients, with strict limitations on eligibility.

©Sebastian Kaulitzki/thinkstockphotos.com

But the time requirement and questions on how this counseling would be covered could make it challenging for patients to make this decision alongside their primary care physician.

“One of the most interesting things in the Medicare requirement for payment focuses on the counseling visit,” said Steven Zeliadt, Ph.D., core investigator at Veterans Affairs Health Services Research & Development Services and professor at the University of Washington, Seattle. “That’s very different than other cancer screening tests, and for Medicare to really be encouraging that and requiring that is something providers and systems are going to have to figure out how to offer and make sure that [this] actually happens.”

Dr. Zeliadt said that he expects to see specialized screening centers similar to those related to pulmonary or mammography screening to gain traction. These will be the places that integrate both parts of the screening by conducting the LDCT test as well as providing the prescreen counseling. This differs from the model used for colon cancer and prostate cancer screening, where the consultation and decision to conduct screening tests are typically done with the primary care physician.

“The Medicare guidelines encourages that [counseling] as well, to make sure that that’s a visit that gets built in,” Dr. Zeliadt said.

Such centers exist now, he noted. “They hire counselors and [conduct] an hour-long prescreening visit that happens with a counselor to talk about lung cancer screening, [the length of which] could never happen in a primary care setting.”

©picsfive/Fotolia.com

This model does not take advantage of the physician/patient relationship, he added. “There is an opportunity for a familiar provider to engage patients around counseling, so the more that we move CT screening outside of primary care, it takes away from the long-term relationship that providers have” with their patients, he said, including knowing more deeply the risks a patient has, as well as the patient’s history with smoking and attempts to quit.

It also takes away opportunities to maintain conversations about smoking cessation, which could be important as screening sometimes deemphasizes the need to quit in patient’s eyes because patients “feel protected by screening.”

The CMS is soliciting comments on the proposed national coverage decision until Dec. 10.

[email protected]

A counseling requirement included in Medicare’s proposed decision to cover screening for lung cancer with low-dose computed tomography could pull primary care physicians out of the decision loop.

The proposed national coverage decision from the Centers for Medicare & Medicaid Services, announced Nov. 10, includes a requirement that patients “receive a written order for [low-dose computed tomography screening] during a lung cancer screening counseling and shared decision making visit, furnished by a physician ... or qualified nonphysician practitioner.” CMS has proposed covering low-dose computed tomography (LDCT) screening only for certain high-risk patients, with strict limitations on eligibility.

©Sebastian Kaulitzki/thinkstockphotos.com

But the time requirement and questions on how this counseling would be covered could make it challenging for patients to make this decision alongside their primary care physician.

“One of the most interesting things in the Medicare requirement for payment focuses on the counseling visit,” said Steven Zeliadt, Ph.D., core investigator at Veterans Affairs Health Services Research & Development Services and professor at the University of Washington, Seattle. “That’s very different than other cancer screening tests, and for Medicare to really be encouraging that and requiring that is something providers and systems are going to have to figure out how to offer and make sure that [this] actually happens.”

Dr. Zeliadt said that he expects to see specialized screening centers similar to those related to pulmonary or mammography screening to gain traction. These will be the places that integrate both parts of the screening by conducting the LDCT test as well as providing the prescreen counseling. This differs from the model used for colon cancer and prostate cancer screening, where the consultation and decision to conduct screening tests are typically done with the primary care physician.

“The Medicare guidelines encourages that [counseling] as well, to make sure that that’s a visit that gets built in,” Dr. Zeliadt said.

Such centers exist now, he noted. “They hire counselors and [conduct] an hour-long prescreening visit that happens with a counselor to talk about lung cancer screening, [the length of which] could never happen in a primary care setting.”

©picsfive/Fotolia.com

This model does not take advantage of the physician/patient relationship, he added. “There is an opportunity for a familiar provider to engage patients around counseling, so the more that we move CT screening outside of primary care, it takes away from the long-term relationship that providers have” with their patients, he said, including knowing more deeply the risks a patient has, as well as the patient’s history with smoking and attempts to quit.

It also takes away opportunities to maintain conversations about smoking cessation, which could be important as screening sometimes deemphasizes the need to quit in patient’s eyes because patients “feel protected by screening.”

The CMS is soliciting comments on the proposed national coverage decision until Dec. 10.

[email protected]

A counseling requirement included in Medicare’s proposed decision to cover screening for lung cancer with low-dose computed tomography could pull primary care physicians out of the decision loop.

The proposed national coverage decision from the Centers for Medicare & Medicaid Services, announced Nov. 10, includes a requirement that patients “receive a written order for [low-dose computed tomography screening] during a lung cancer screening counseling and shared decision making visit, furnished by a physician ... or qualified nonphysician practitioner.” CMS has proposed covering low-dose computed tomography (LDCT) screening only for certain high-risk patients, with strict limitations on eligibility.

©Sebastian Kaulitzki/thinkstockphotos.com

But the time requirement and questions on how this counseling would be covered could make it challenging for patients to make this decision alongside their primary care physician.

“One of the most interesting things in the Medicare requirement for payment focuses on the counseling visit,” said Steven Zeliadt, Ph.D., core investigator at Veterans Affairs Health Services Research & Development Services and professor at the University of Washington, Seattle. “That’s very different than other cancer screening tests, and for Medicare to really be encouraging that and requiring that is something providers and systems are going to have to figure out how to offer and make sure that [this] actually happens.”

Dr. Zeliadt said that he expects to see specialized screening centers similar to those related to pulmonary or mammography screening to gain traction. These will be the places that integrate both parts of the screening by conducting the LDCT test as well as providing the prescreen counseling. This differs from the model used for colon cancer and prostate cancer screening, where the consultation and decision to conduct screening tests are typically done with the primary care physician.

“The Medicare guidelines encourages that [counseling] as well, to make sure that that’s a visit that gets built in,” Dr. Zeliadt said.

Such centers exist now, he noted. “They hire counselors and [conduct] an hour-long prescreening visit that happens with a counselor to talk about lung cancer screening, [the length of which] could never happen in a primary care setting.”

©picsfive/Fotolia.com

This model does not take advantage of the physician/patient relationship, he added. “There is an opportunity for a familiar provider to engage patients around counseling, so the more that we move CT screening outside of primary care, it takes away from the long-term relationship that providers have” with their patients, he said, including knowing more deeply the risks a patient has, as well as the patient’s history with smoking and attempts to quit.

It also takes away opportunities to maintain conversations about smoking cessation, which could be important as screening sometimes deemphasizes the need to quit in patient’s eyes because patients “feel protected by screening.”

The CMS is soliciting comments on the proposed national coverage decision until Dec. 10.

[email protected]

Medicare patients who are at high risk for lung cancer would be able to get screening using low-dose computed tomography under a proposed national coverage decision announced Nov. 10.

©picsfive/Fotolia.com

“The evidence is sufficient to add a lung cancer screening counseling and shared decision making visit, and for appropriate beneficiaries, screening for lung cancer with low-dose computed tomography, once per year, as an additional preventive service benefit under the Medicare program,” officials from the Centers for Medicare & Medicaid Services wrote in the proposed decision.

The agency would strictly limit eligibility criteria for low-dose CT screening. Appropriate patients would be 55-74 years old, show no signs of lung disease, and have a smoking history of at least 30 pack-years. Further, appropriate patients would be either current smokers or would have quit within the past 15 years. The written order for the low-dose CT screening must come after a lung cancer screening counseling and shared decision making visit with a physician or qualified nonphysician practitioner. Subsequent screenings orders could be received in writing during any appropriate visit.

The proposed coverage national decision comes despite a recommendation from the Medicare Evidence Development and Coverage Advisory Committee earlier this year to not cover low-dose CT screening. A study published Nov. 5 in the New England Journal of Medicine found low-dose CT screening cost effective for patients at high risk for lung cancer (2014;371:1793-802).

CMS will accept comments on the proposed coverage decision for 30 days, starting Nov. 10.

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Medicare patients who are at high risk for lung cancer would be able to get screening using low-dose computed tomography under a proposed national coverage decision announced Nov. 10.

©picsfive/Fotolia.com

“The evidence is sufficient to add a lung cancer screening counseling and shared decision making visit, and for appropriate beneficiaries, screening for lung cancer with low-dose computed tomography, once per year, as an additional preventive service benefit under the Medicare program,” officials from the Centers for Medicare & Medicaid Services wrote in the proposed decision.

The agency would strictly limit eligibility criteria for low-dose CT screening. Appropriate patients would be 55-74 years old, show no signs of lung disease, and have a smoking history of at least 30 pack-years. Further, appropriate patients would be either current smokers or would have quit within the past 15 years. The written order for the low-dose CT screening must come after a lung cancer screening counseling and shared decision making visit with a physician or qualified nonphysician practitioner. Subsequent screenings orders could be received in writing during any appropriate visit.

The proposed coverage national decision comes despite a recommendation from the Medicare Evidence Development and Coverage Advisory Committee earlier this year to not cover low-dose CT screening. A study published Nov. 5 in the New England Journal of Medicine found low-dose CT screening cost effective for patients at high risk for lung cancer (2014;371:1793-802).

CMS will accept comments on the proposed coverage decision for 30 days, starting Nov. 10.

[email protected]

Medicare patients who are at high risk for lung cancer would be able to get screening using low-dose computed tomography under a proposed national coverage decision announced Nov. 10.

©picsfive/Fotolia.com

“The evidence is sufficient to add a lung cancer screening counseling and shared decision making visit, and for appropriate beneficiaries, screening for lung cancer with low-dose computed tomography, once per year, as an additional preventive service benefit under the Medicare program,” officials from the Centers for Medicare & Medicaid Services wrote in the proposed decision.

The agency would strictly limit eligibility criteria for low-dose CT screening. Appropriate patients would be 55-74 years old, show no signs of lung disease, and have a smoking history of at least 30 pack-years. Further, appropriate patients would be either current smokers or would have quit within the past 15 years. The written order for the low-dose CT screening must come after a lung cancer screening counseling and shared decision making visit with a physician or qualified nonphysician practitioner. Subsequent screenings orders could be received in writing during any appropriate visit.

The proposed coverage national decision comes despite a recommendation from the Medicare Evidence Development and Coverage Advisory Committee earlier this year to not cover low-dose CT screening. A study published Nov. 5 in the New England Journal of Medicine found low-dose CT screening cost effective for patients at high risk for lung cancer (2014;371:1793-802).

CMS will accept comments on the proposed coverage decision for 30 days, starting Nov. 10.

[email protected]

California voters rejected a ballot initiative that would have required doctors to submit to random drug and alcohol testing within 12 hours of when an adverse event has been identified, while voters in South Dakota approved a measure to loosen insurance companies’ provider panels.

With all precincts reporting, more than 67% of California voters (nearly 3.42 million) voted no on Proposition 46, a measure that doctors in the state said would unreasonably penalize doctors unable to meet testing rules and lead to excessive suspensions. The initiative applied only to doctors who practice in hospitals or have hospital privileges.

The ballot initiative also contained two other components – a requirement that doctors consult a statewide database before prescribing schedule II and schedule III drugs and a raising of the medical malpractice cap on noneconomic damages from $250,000 to $1.1 million. Doctors argued that the database lacked the funding and staff to be effective in identifying patients engaged in doctor-shopping or otherwise abusing prescription controlled substances.

In South Dakota, 61.8% of the voters (166,351, with all precincts reporting) approved Measure 17, which allows providers who are willing to meet a health insurer’s coverage terms to provide health care services to insured patients without having to join that patient’s insurance plan network, and protects patients from out-of-network costs if they use that physician.

Voters in Arizona approved Proposition 303, which allows eligible patients with a terminal illness that has no Food and Drug Administration–approved treatment option to have access to an investigational drug, provided the drug has successfully completed phase I testing and remains under clinical investigation. The pharmaceutical manufacturer would decide whether to provide access, and insurance companies are not required under the measure to provide coverage for it. The measure also offered some liability protection for physicians who recommend the investigational treatment. More than 78% of the votes (849,350, with 97% of the precincts reporting) supported the measure.

In Illinois, voters supported a ballot initiative that would require insurance plans in the state that have prescription drug coverage to “include prescription birth control as part of that coverage.” No details were included in the text of the initiative on the scope of what needs to be included, but its passage means the state legislature must enact a law to implement the will of the voters. Sixty-six percent of the votes (2.2 million, with 99 percent of precincts reporting) were in favor of this initiative.

Residents in three states acted on abortion-related measures. In North Dakota, a ballot initiative would have amended the state constitution to provide for the “inalienable right to life” beginning at conception. With all precincts reporting, the amendment failed, with more than 64% of votes against. In Colorado, a constitutional amendment to include the unborn in the definition of “person” and “child” in the state criminal code failed, with more than 64% of the votes (nearly 1.2 million, with 94% of precincts reporting) going against the amendment.

And in Tennessee, voters approved a constitutional amendment that empowers the state legislature “to enact, amend, or repeal statutes regarding abortion, including but not limited to, circumstances of pregnancy resulting from rape or incest, or when necessary to save the life of the mother.” It passed with more than 52% of the votes (728,751 with 99 percent of the precincts reporting). The amendment was in reaction to a 2000 state supreme court ruling that struck down a number of state laws that placed limits around abortions.

[email protected]

California voters rejected a ballot initiative that would have required doctors to submit to random drug and alcohol testing within 12 hours of when an adverse event has been identified, while voters in South Dakota approved a measure to loosen insurance companies’ provider panels.

With all precincts reporting, more than 67% of California voters (nearly 3.42 million) voted no on Proposition 46, a measure that doctors in the state said would unreasonably penalize doctors unable to meet testing rules and lead to excessive suspensions. The initiative applied only to doctors who practice in hospitals or have hospital privileges.

The ballot initiative also contained two other components – a requirement that doctors consult a statewide database before prescribing schedule II and schedule III drugs and a raising of the medical malpractice cap on noneconomic damages from $250,000 to $1.1 million. Doctors argued that the database lacked the funding and staff to be effective in identifying patients engaged in doctor-shopping or otherwise abusing prescription controlled substances.

In South Dakota, 61.8% of the voters (166,351, with all precincts reporting) approved Measure 17, which allows providers who are willing to meet a health insurer’s coverage terms to provide health care services to insured patients without having to join that patient’s insurance plan network, and protects patients from out-of-network costs if they use that physician.

Voters in Arizona approved Proposition 303, which allows eligible patients with a terminal illness that has no Food and Drug Administration–approved treatment option to have access to an investigational drug, provided the drug has successfully completed phase I testing and remains under clinical investigation. The pharmaceutical manufacturer would decide whether to provide access, and insurance companies are not required under the measure to provide coverage for it. The measure also offered some liability protection for physicians who recommend the investigational treatment. More than 78% of the votes (849,350, with 97% of the precincts reporting) supported the measure.

In Illinois, voters supported a ballot initiative that would require insurance plans in the state that have prescription drug coverage to “include prescription birth control as part of that coverage.” No details were included in the text of the initiative on the scope of what needs to be included, but its passage means the state legislature must enact a law to implement the will of the voters. Sixty-six percent of the votes (2.2 million, with 99 percent of precincts reporting) were in favor of this initiative.

Residents in three states acted on abortion-related measures. In North Dakota, a ballot initiative would have amended the state constitution to provide for the “inalienable right to life” beginning at conception. With all precincts reporting, the amendment failed, with more than 64% of votes against. In Colorado, a constitutional amendment to include the unborn in the definition of “person” and “child” in the state criminal code failed, with more than 64% of the votes (nearly 1.2 million, with 94% of precincts reporting) going against the amendment.

And in Tennessee, voters approved a constitutional amendment that empowers the state legislature “to enact, amend, or repeal statutes regarding abortion, including but not limited to, circumstances of pregnancy resulting from rape or incest, or when necessary to save the life of the mother.” It passed with more than 52% of the votes (728,751 with 99 percent of the precincts reporting). The amendment was in reaction to a 2000 state supreme court ruling that struck down a number of state laws that placed limits around abortions.

[email protected]

California voters rejected a ballot initiative that would have required doctors to submit to random drug and alcohol testing within 12 hours of when an adverse event has been identified, while voters in South Dakota approved a measure to loosen insurance companies’ provider panels.

With all precincts reporting, more than 67% of California voters (nearly 3.42 million) voted no on Proposition 46, a measure that doctors in the state said would unreasonably penalize doctors unable to meet testing rules and lead to excessive suspensions. The initiative applied only to doctors who practice in hospitals or have hospital privileges.

The ballot initiative also contained two other components – a requirement that doctors consult a statewide database before prescribing schedule II and schedule III drugs and a raising of the medical malpractice cap on noneconomic damages from $250,000 to $1.1 million. Doctors argued that the database lacked the funding and staff to be effective in identifying patients engaged in doctor-shopping or otherwise abusing prescription controlled substances.

In South Dakota, 61.8% of the voters (166,351, with all precincts reporting) approved Measure 17, which allows providers who are willing to meet a health insurer’s coverage terms to provide health care services to insured patients without having to join that patient’s insurance plan network, and protects patients from out-of-network costs if they use that physician.

Voters in Arizona approved Proposition 303, which allows eligible patients with a terminal illness that has no Food and Drug Administration–approved treatment option to have access to an investigational drug, provided the drug has successfully completed phase I testing and remains under clinical investigation. The pharmaceutical manufacturer would decide whether to provide access, and insurance companies are not required under the measure to provide coverage for it. The measure also offered some liability protection for physicians who recommend the investigational treatment. More than 78% of the votes (849,350, with 97% of the precincts reporting) supported the measure.

In Illinois, voters supported a ballot initiative that would require insurance plans in the state that have prescription drug coverage to “include prescription birth control as part of that coverage.” No details were included in the text of the initiative on the scope of what needs to be included, but its passage means the state legislature must enact a law to implement the will of the voters. Sixty-six percent of the votes (2.2 million, with 99 percent of precincts reporting) were in favor of this initiative.

Residents in three states acted on abortion-related measures. In North Dakota, a ballot initiative would have amended the state constitution to provide for the “inalienable right to life” beginning at conception. With all precincts reporting, the amendment failed, with more than 64% of votes against. In Colorado, a constitutional amendment to include the unborn in the definition of “person” and “child” in the state criminal code failed, with more than 64% of the votes (nearly 1.2 million, with 94% of precincts reporting) going against the amendment.

And in Tennessee, voters approved a constitutional amendment that empowers the state legislature “to enact, amend, or repeal statutes regarding abortion, including but not limited to, circumstances of pregnancy resulting from rape or incest, or when necessary to save the life of the mother.” It passed with more than 52% of the votes (728,751 with 99 percent of the precincts reporting). The amendment was in reaction to a 2000 state supreme court ruling that struck down a number of state laws that placed limits around abortions.

[email protected]

Computed tomography screening is cost effective for patients at high risk for lung cancer, according to an analysis published Nov. 5 in the New England Journal of Medicine.

Researchers examined data from the National Lung Screening Trial (NLST) and estimated that screening for lung cancer with low-dose CT would cost $81,000 per quality-adjusted life-year gained, though that number varied widely when researchers looked at specific subgroups (N. Engl. J Med. 2014;371:1793-802 [doi:10.1056/NEJMoa1312547]).

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The NLST, a 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 via low-dose CT (N. Engl. J. Med. 2013:368:1980-91).

“Screening with low-dose CT was much more cost-effective among women than among men and among groups with a higher risk of lung cancer than among those with a lower risk,” wrote Dr. William C. Black of Dartmouth-Hitchcock Medical Center, Lebanon, N.H., and colleagues. “Screening with low-dose CT was also more cost-effective for current smokers than for former smokers and for the older groups than for the youngest group, findings that are probably due to the higher risk of lung cancer among current smokers and older patients.”

The results of the cost-effectiveness analysis were published days in advance of an expected Centers for Medicare & Medicaid Services decision on how it will cover CT screening for lung cancer.

For men, the cost per quality-adjusted life-year gained was $147,000, compared with $46,000 in women. Those who were aged 60-64 years had the lowest cost per quality-adjusted life-year gained of $48,000, with those aged 65-69 years at $54,000. However, the cost per quality-adjusted life-year gained reached $117,000 for those aged 70-74 years and $152,000 for those aged 55-59 years.

Smoking status also had a wide variation, with the cost per quality-adjusted life-year gained for current smokers at $43,000, while those who were former smokers had a cost per quality-adjusted life-year gained of $615,000.

In December 2013, the U.S. Preventive Services Task Force gave low-dose CT screening for patients at high risk of lung cancer a “B” recommendation, meaning that the task force recommends the service and has a “high certainty that the net benefit is moderate or there is moderate certainty that the net benefit is moderate to substantial.” Under the Affordable Care Act, “A” and “B” recommendations from the task force must be covered by insurers at no cost to patients.

However, earlier this year, members of the Medicare Evidence Development and Coverage Advisory Committee recommended that Medicare not cover screening, saying that on average, they had low confidence that there is adequate evidence that the benefits outweigh the harms of low-dose CT screening in the Medicare population.

“The determination of whether screening outside the trial will be cost-effective will depend on how screening is implemented,” Dr. Black and his colleagues concluded.

[email protected]

Computed tomography screening is cost effective for patients at high risk for lung cancer, according to an analysis published Nov. 5 in the New England Journal of Medicine.

Researchers examined data from the National Lung Screening Trial (NLST) and estimated that screening for lung cancer with low-dose CT would cost $81,000 per quality-adjusted life-year gained, though that number varied widely when researchers looked at specific subgroups (N. Engl. J Med. 2014;371:1793-802 [doi:10.1056/NEJMoa1312547]).

thinkstockphotos.com

The NLST, a 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 via low-dose CT (N. Engl. J. Med. 2013:368:1980-91).

“Screening with low-dose CT was much more cost-effective among women than among men and among groups with a higher risk of lung cancer than among those with a lower risk,” wrote Dr. William C. Black of Dartmouth-Hitchcock Medical Center, Lebanon, N.H., and colleagues. “Screening with low-dose CT was also more cost-effective for current smokers than for former smokers and for the older groups than for the youngest group, findings that are probably due to the higher risk of lung cancer among current smokers and older patients.”

The results of the cost-effectiveness analysis were published days in advance of an expected Centers for Medicare & Medicaid Services decision on how it will cover CT screening for lung cancer.

For men, the cost per quality-adjusted life-year gained was $147,000, compared with $46,000 in women. Those who were aged 60-64 years had the lowest cost per quality-adjusted life-year gained of $48,000, with those aged 65-69 years at $54,000. However, the cost per quality-adjusted life-year gained reached $117,000 for those aged 70-74 years and $152,000 for those aged 55-59 years.

Smoking status also had a wide variation, with the cost per quality-adjusted life-year gained for current smokers at $43,000, while those who were former smokers had a cost per quality-adjusted life-year gained of $615,000.

In December 2013, the U.S. Preventive Services Task Force gave low-dose CT screening for patients at high risk of lung cancer a “B” recommendation, meaning that the task force recommends the service and has a “high certainty that the net benefit is moderate or there is moderate certainty that the net benefit is moderate to substantial.” Under the Affordable Care Act, “A” and “B” recommendations from the task force must be covered by insurers at no cost to patients.

However, earlier this year, members of the Medicare Evidence Development and Coverage Advisory Committee recommended that Medicare not cover screening, saying that on average, they had low confidence that there is adequate evidence that the benefits outweigh the harms of low-dose CT screening in the Medicare population.

“The determination of whether screening outside the trial will be cost-effective will depend on how screening is implemented,” Dr. Black and his colleagues concluded.

[email protected]

Computed tomography screening is cost effective for patients at high risk for lung cancer, according to an analysis published Nov. 5 in the New England Journal of Medicine.

Researchers examined data from the National Lung Screening Trial (NLST) and estimated that screening for lung cancer with low-dose CT would cost $81,000 per quality-adjusted life-year gained, though that number varied widely when researchers looked at specific subgroups (N. Engl. J Med. 2014;371:1793-802 [doi:10.1056/NEJMoa1312547]).

thinkstockphotos.com

The NLST, a 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 via low-dose CT (N. Engl. J. Med. 2013:368:1980-91).

“Screening with low-dose CT was much more cost-effective among women than among men and among groups with a higher risk of lung cancer than among those with a lower risk,” wrote Dr. William C. Black of Dartmouth-Hitchcock Medical Center, Lebanon, N.H., and colleagues. “Screening with low-dose CT was also more cost-effective for current smokers than for former smokers and for the older groups than for the youngest group, findings that are probably due to the higher risk of lung cancer among current smokers and older patients.”

The results of the cost-effectiveness analysis were published days in advance of an expected Centers for Medicare & Medicaid Services decision on how it will cover CT screening for lung cancer.

For men, the cost per quality-adjusted life-year gained was $147,000, compared with $46,000 in women. Those who were aged 60-64 years had the lowest cost per quality-adjusted life-year gained of $48,000, with those aged 65-69 years at $54,000. However, the cost per quality-adjusted life-year gained reached $117,000 for those aged 70-74 years and $152,000 for those aged 55-59 years.

Smoking status also had a wide variation, with the cost per quality-adjusted life-year gained for current smokers at $43,000, while those who were former smokers had a cost per quality-adjusted life-year gained of $615,000.

In December 2013, the U.S. Preventive Services Task Force gave low-dose CT screening for patients at high risk of lung cancer a “B” recommendation, meaning that the task force recommends the service and has a “high certainty that the net benefit is moderate or there is moderate certainty that the net benefit is moderate to substantial.” Under the Affordable Care Act, “A” and “B” recommendations from the task force must be covered by insurers at no cost to patients.

However, earlier this year, members of the Medicare Evidence Development and Coverage Advisory Committee recommended that Medicare not cover screening, saying that on average, they had low confidence that there is adequate evidence that the benefits outweigh the harms of low-dose CT screening in the Medicare population.

“The determination of whether screening outside the trial will be cost-effective will depend on how screening is implemented,” Dr. Black and his colleagues concluded.

[email protected]

The outcome of the 2014 midterm election could impact continued implementation of the Affordable Care Act.

“Even though health care is only one of a number of top issues in the 2014 election, the majority party in Congress will claim it has a mandate for its priorities on what is still a controversial national health care issue,” according to an analysis of public opinion polls by Robert Blendon, Sc.D., and John Benson of the Harvard School of Public Health published Oct. 29 in the New England Journal of Medicine.

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Even if Republicans take control of the Senate and maintain control of the House of Representatives, they are unlikely to be successful at repealing the ACA, but they “could … reduce federal support for health insurance subsidies, Medicaid expansion, public health grants, innovation investments, program administrative information and outlays for research,” Dr. Blendon and Mr. Benson suggested.

A Republican-controlled Congress also would probably delay employer and individual mandates and reduce taxes on employers, insurers, and health care companies.

If Democrats maintain their majority in the Senate, the authors predicted continued ACA implementation and more states to expand Medicaid services.

The investigators looked at 27 public opinion polls from 14 organizations (N. Engl. J. Med. 2014 Oct. 29 doi:10.1056/NEJMsr1412118). They noted that “a larger proportion of likely voters say they are less likely to vote for a congressional candidate who supports the ACA (40%) than say that they are more likely to vote for such a candidate (31%).” Twenty-seven percent say that a candidate’s stance on the ACA will not impact their vote.

More independent voters say that they are less likely to vote for an anti-ACA candidate (43%) than a pro-ACA candidate (25%).

Finally, Dr. Blendon and Mr. Benson wrote that, while a majority of voters do not favor outright repeal of the health care reform law, many favor either repealing the ACA (31%) or scaling it back (23%).

[email protected]

The outcome of the 2014 midterm election could impact continued implementation of the Affordable Care Act.

“Even though health care is only one of a number of top issues in the 2014 election, the majority party in Congress will claim it has a mandate for its priorities on what is still a controversial national health care issue,” according to an analysis of public opinion polls by Robert Blendon, Sc.D., and John Benson of the Harvard School of Public Health published Oct. 29 in the New England Journal of Medicine.

© Hemera / ThinkStockPhotos.com

Even if Republicans take control of the Senate and maintain control of the House of Representatives, they are unlikely to be successful at repealing the ACA, but they “could … reduce federal support for health insurance subsidies, Medicaid expansion, public health grants, innovation investments, program administrative information and outlays for research,” Dr. Blendon and Mr. Benson suggested.

A Republican-controlled Congress also would probably delay employer and individual mandates and reduce taxes on employers, insurers, and health care companies.

If Democrats maintain their majority in the Senate, the authors predicted continued ACA implementation and more states to expand Medicaid services.

The investigators looked at 27 public opinion polls from 14 organizations (N. Engl. J. Med. 2014 Oct. 29 doi:10.1056/NEJMsr1412118). They noted that “a larger proportion of likely voters say they are less likely to vote for a congressional candidate who supports the ACA (40%) than say that they are more likely to vote for such a candidate (31%).” Twenty-seven percent say that a candidate’s stance on the ACA will not impact their vote.

More independent voters say that they are less likely to vote for an anti-ACA candidate (43%) than a pro-ACA candidate (25%).

Finally, Dr. Blendon and Mr. Benson wrote that, while a majority of voters do not favor outright repeal of the health care reform law, many favor either repealing the ACA (31%) or scaling it back (23%).

[email protected]

The outcome of the 2014 midterm election could impact continued implementation of the Affordable Care Act.

“Even though health care is only one of a number of top issues in the 2014 election, the majority party in Congress will claim it has a mandate for its priorities on what is still a controversial national health care issue,” according to an analysis of public opinion polls by Robert Blendon, Sc.D., and John Benson of the Harvard School of Public Health published Oct. 29 in the New England Journal of Medicine.

© Hemera / ThinkStockPhotos.com

Even if Republicans take control of the Senate and maintain control of the House of Representatives, they are unlikely to be successful at repealing the ACA, but they “could … reduce federal support for health insurance subsidies, Medicaid expansion, public health grants, innovation investments, program administrative information and outlays for research,” Dr. Blendon and Mr. Benson suggested.

A Republican-controlled Congress also would probably delay employer and individual mandates and reduce taxes on employers, insurers, and health care companies.

If Democrats maintain their majority in the Senate, the authors predicted continued ACA implementation and more states to expand Medicaid services.

The investigators looked at 27 public opinion polls from 14 organizations (N. Engl. J. Med. 2014 Oct. 29 doi:10.1056/NEJMsr1412118). They noted that “a larger proportion of likely voters say they are less likely to vote for a congressional candidate who supports the ACA (40%) than say that they are more likely to vote for such a candidate (31%).” Twenty-seven percent say that a candidate’s stance on the ACA will not impact their vote.

More independent voters say that they are less likely to vote for an anti-ACA candidate (43%) than a pro-ACA candidate (25%).

Finally, Dr. Blendon and Mr. Benson wrote that, while a majority of voters do not favor outright repeal of the health care reform law, many favor either repealing the ACA (31%) or scaling it back (23%).

[email protected]

A Massachusetts affordable care organization was successful at improving patients’ health while lowering costs, according to a study published Oct. 29 in the New England Journal of Medicine.

On the spending side, claims for patients enrolled in the Blue Cross Blue Shield of Massachusetts Alternative Quality Contract (AQC) grew an average of $62.21 per enrollee per quarter less than they did in a control group of patients in other states during the 2009-2012 study period, Dr. Zirui Song of Harvard Medical School, Boston, and his colleagues reported.

“Claims savings were concentrated in the outpatient-facility setting and in procedures, imaging, and tests, explained by both reduced prices and reduced utilization,” the investigators wrote. “By 2012, the total payment growth for the AQC (claims and incentive payments combined) was below the Massachusetts state spending target of 3.6% and below the projected spending that was based on controls.”

On the quality side, the “average performance of the 2009 AQC cohort on measures of chronic disease management increased from 79.6% in the period from 2007 through 2008 to 84.5% in the period from 2009 through 2012, as compared with 79.8% and 80.8% in the respective periods for the HEDIS [Healthcare Effectiveness Data and Information Set] national average” (N. Engl. J. Med. 2014:371;1704-14 [doi:10.1056/NEJMsa1404026]).

The authors noted that state payment reform legislation in 2012, as well as Medicare’s Pioneer ACO program, may have affected the latter portion of the analysis, though most reforms did postdate the analysis.

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Although “our findings for 2012 may be susceptible to spillover effects, and anticipatory effects from other contracts may also play a role, our prior analyses that used internal controls, the consistency of the sensitivity analyses, and qualitative findings from interviews with providers suggest that the AQC played a meaningful role,” Dr. Song and his colleagues wrote.

The findings might not translate to the Medicare ACO program since most Medicare ACO contracts “are one-sided with shared savings only. Moreover, prices in Medicare are largely uniform rather than negotiated, so savings for Medicare would require reductions in utilization or shifts to less-expensive settings (rather than referrals to less-expensive providers). Similarly, our results may not be generalizable to other states, which face different constraints and challenges,” they said.

[email protected]

A Massachusetts affordable care organization was successful at improving patients’ health while lowering costs, according to a study published Oct. 29 in the New England Journal of Medicine.

On the spending side, claims for patients enrolled in the Blue Cross Blue Shield of Massachusetts Alternative Quality Contract (AQC) grew an average of $62.21 per enrollee per quarter less than they did in a control group of patients in other states during the 2009-2012 study period, Dr. Zirui Song of Harvard Medical School, Boston, and his colleagues reported.

“Claims savings were concentrated in the outpatient-facility setting and in procedures, imaging, and tests, explained by both reduced prices and reduced utilization,” the investigators wrote. “By 2012, the total payment growth for the AQC (claims and incentive payments combined) was below the Massachusetts state spending target of 3.6% and below the projected spending that was based on controls.”

On the quality side, the “average performance of the 2009 AQC cohort on measures of chronic disease management increased from 79.6% in the period from 2007 through 2008 to 84.5% in the period from 2009 through 2012, as compared with 79.8% and 80.8% in the respective periods for the HEDIS [Healthcare Effectiveness Data and Information Set] national average” (N. Engl. J. Med. 2014:371;1704-14 [doi:10.1056/NEJMsa1404026]).

The authors noted that state payment reform legislation in 2012, as well as Medicare’s Pioneer ACO program, may have affected the latter portion of the analysis, though most reforms did postdate the analysis.

© crazydiva/Thinkstock

Although “our findings for 2012 may be susceptible to spillover effects, and anticipatory effects from other contracts may also play a role, our prior analyses that used internal controls, the consistency of the sensitivity analyses, and qualitative findings from interviews with providers suggest that the AQC played a meaningful role,” Dr. Song and his colleagues wrote.

The findings might not translate to the Medicare ACO program since most Medicare ACO contracts “are one-sided with shared savings only. Moreover, prices in Medicare are largely uniform rather than negotiated, so savings for Medicare would require reductions in utilization or shifts to less-expensive settings (rather than referrals to less-expensive providers). Similarly, our results may not be generalizable to other states, which face different constraints and challenges,” they said.

[email protected]

A Massachusetts affordable care organization was successful at improving patients’ health while lowering costs, according to a study published Oct. 29 in the New England Journal of Medicine.

On the spending side, claims for patients enrolled in the Blue Cross Blue Shield of Massachusetts Alternative Quality Contract (AQC) grew an average of $62.21 per enrollee per quarter less than they did in a control group of patients in other states during the 2009-2012 study period, Dr. Zirui Song of Harvard Medical School, Boston, and his colleagues reported.

“Claims savings were concentrated in the outpatient-facility setting and in procedures, imaging, and tests, explained by both reduced prices and reduced utilization,” the investigators wrote. “By 2012, the total payment growth for the AQC (claims and incentive payments combined) was below the Massachusetts state spending target of 3.6% and below the projected spending that was based on controls.”

On the quality side, the “average performance of the 2009 AQC cohort on measures of chronic disease management increased from 79.6% in the period from 2007 through 2008 to 84.5% in the period from 2009 through 2012, as compared with 79.8% and 80.8% in the respective periods for the HEDIS [Healthcare Effectiveness Data and Information Set] national average” (N. Engl. J. Med. 2014:371;1704-14 [doi:10.1056/NEJMsa1404026]).

The authors noted that state payment reform legislation in 2012, as well as Medicare’s Pioneer ACO program, may have affected the latter portion of the analysis, though most reforms did postdate the analysis.

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Although “our findings for 2012 may be susceptible to spillover effects, and anticipatory effects from other contracts may also play a role, our prior analyses that used internal controls, the consistency of the sensitivity analyses, and qualitative findings from interviews with providers suggest that the AQC played a meaningful role,” Dr. Song and his colleagues wrote.

The findings might not translate to the Medicare ACO program since most Medicare ACO contracts “are one-sided with shared savings only. Moreover, prices in Medicare are largely uniform rather than negotiated, so savings for Medicare would require reductions in utilization or shifts to less-expensive settings (rather than referrals to less-expensive providers). Similarly, our results may not be generalizable to other states, which face different constraints and challenges,” they said.

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