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Consumer Reports: Sunscreen SPF Claims Largely Inaccurate
An analysis of 20 sunscreens by Consumer Reports found that only two provided the SPF protection claimed on the label.
The analysis – and rating of overall performance of those sunscreens – was released by the advocacy organization just ahead of Memorial Day weekend, the unofficial start of summer.
Consumer Reports decided to put those SPF claims to the test in its own labs. The only two that tested at the SPF level claimed were BullFrog WaterArmor Sport InstaCool SPF 50-plus and Coppertone Sensitive Skin SPF 50. One product, Beyond Coastal Natural SPF 30, tested at half its claim. The other products tested at 4%-40% below the claimed SPF.According to a survey of 1,000 adults conducted by the Consumer Reports National Research Center, a product’s sun protection factor (SPF) was the most important factor in determining what sunscreen to purchase.
"We can’t say why our test results differ from the manufacturers’ claims, but they show that SPF isn’t always carved in stone," the Consumer Reports authors wrote.
The group also debunked some of what it called the "myths" about sunscreens, including that sprays provide the best coverage, and that "natural" sunscreens are safer than other sunscreens. In addition, mineral-based sunscreens are no more effective than other sunscreens, says Consumer Reports.
Also, the article said that there is no practical or meaningful difference between a sunscreen labeled for children and one for adults. In most cases, the active ingredients and the concentration of those ingredients are exactly the same. Some of the kids’ sunscreens contain only zinc oxide or titanium dioxide, which may be less irritating than products that contain chemical sunscreens such as avobenzone, according to the article.
The organization tested UVB protection by spreading a standard amount of sunscreen on a volunteer’s back, immersing them in a tub of water for a bit, and then exposing them to six intensities of UVB light from a sun simulator for a standard period of time. The skin patches were examined the next day for redness and the measured SPF was used to calculate the UVB scores.
For UVA, Consumer Reports conducted a critical wavelength test similar to what the Food and Drug Administration requires of manufacturers. The test assesses how well UV rays are absorbed by clear plastic plates that have been treated with the sunscreen.
The overall performance score was based on both the UVA and UVB results.
Among lotions, the best-performing product was Coppertone’s Water Babies SPF 50. Walmart’s less-expensive Equate Ultra Protection SPF 50 was the second-best performer. BullFrog’s WaterArmor Sport InstaCool SPF 50-plus was the top performing spray, followed by Target’s Up & Up Sport SPF 50. Banana Boat Ultra Defense Max Skin Protect SPF 110 spray and Neutrogena Ultimate Sport SPF 70-plus lotion were the highest-performing products with ultra-high SPFs.
The article and ratings are available online to subscribers and will be published in the group’s July 2014 print publication, Consumer Reports.
On Twitter @aliciaault
An analysis of 20 sunscreens by Consumer Reports found that only two provided the SPF protection claimed on the label.
The analysis – and rating of overall performance of those sunscreens – was released by the advocacy organization just ahead of Memorial Day weekend, the unofficial start of summer.
Consumer Reports decided to put those SPF claims to the test in its own labs. The only two that tested at the SPF level claimed were BullFrog WaterArmor Sport InstaCool SPF 50-plus and Coppertone Sensitive Skin SPF 50. One product, Beyond Coastal Natural SPF 30, tested at half its claim. The other products tested at 4%-40% below the claimed SPF.According to a survey of 1,000 adults conducted by the Consumer Reports National Research Center, a product’s sun protection factor (SPF) was the most important factor in determining what sunscreen to purchase.
"We can’t say why our test results differ from the manufacturers’ claims, but they show that SPF isn’t always carved in stone," the Consumer Reports authors wrote.
The group also debunked some of what it called the "myths" about sunscreens, including that sprays provide the best coverage, and that "natural" sunscreens are safer than other sunscreens. In addition, mineral-based sunscreens are no more effective than other sunscreens, says Consumer Reports.
Also, the article said that there is no practical or meaningful difference between a sunscreen labeled for children and one for adults. In most cases, the active ingredients and the concentration of those ingredients are exactly the same. Some of the kids’ sunscreens contain only zinc oxide or titanium dioxide, which may be less irritating than products that contain chemical sunscreens such as avobenzone, according to the article.
The organization tested UVB protection by spreading a standard amount of sunscreen on a volunteer’s back, immersing them in a tub of water for a bit, and then exposing them to six intensities of UVB light from a sun simulator for a standard period of time. The skin patches were examined the next day for redness and the measured SPF was used to calculate the UVB scores.
For UVA, Consumer Reports conducted a critical wavelength test similar to what the Food and Drug Administration requires of manufacturers. The test assesses how well UV rays are absorbed by clear plastic plates that have been treated with the sunscreen.
The overall performance score was based on both the UVA and UVB results.
Among lotions, the best-performing product was Coppertone’s Water Babies SPF 50. Walmart’s less-expensive Equate Ultra Protection SPF 50 was the second-best performer. BullFrog’s WaterArmor Sport InstaCool SPF 50-plus was the top performing spray, followed by Target’s Up & Up Sport SPF 50. Banana Boat Ultra Defense Max Skin Protect SPF 110 spray and Neutrogena Ultimate Sport SPF 70-plus lotion were the highest-performing products with ultra-high SPFs.
The article and ratings are available online to subscribers and will be published in the group’s July 2014 print publication, Consumer Reports.
On Twitter @aliciaault
An analysis of 20 sunscreens by Consumer Reports found that only two provided the SPF protection claimed on the label.
The analysis – and rating of overall performance of those sunscreens – was released by the advocacy organization just ahead of Memorial Day weekend, the unofficial start of summer.
Consumer Reports decided to put those SPF claims to the test in its own labs. The only two that tested at the SPF level claimed were BullFrog WaterArmor Sport InstaCool SPF 50-plus and Coppertone Sensitive Skin SPF 50. One product, Beyond Coastal Natural SPF 30, tested at half its claim. The other products tested at 4%-40% below the claimed SPF.According to a survey of 1,000 adults conducted by the Consumer Reports National Research Center, a product’s sun protection factor (SPF) was the most important factor in determining what sunscreen to purchase.
"We can’t say why our test results differ from the manufacturers’ claims, but they show that SPF isn’t always carved in stone," the Consumer Reports authors wrote.
The group also debunked some of what it called the "myths" about sunscreens, including that sprays provide the best coverage, and that "natural" sunscreens are safer than other sunscreens. In addition, mineral-based sunscreens are no more effective than other sunscreens, says Consumer Reports.
Also, the article said that there is no practical or meaningful difference between a sunscreen labeled for children and one for adults. In most cases, the active ingredients and the concentration of those ingredients are exactly the same. Some of the kids’ sunscreens contain only zinc oxide or titanium dioxide, which may be less irritating than products that contain chemical sunscreens such as avobenzone, according to the article.
The organization tested UVB protection by spreading a standard amount of sunscreen on a volunteer’s back, immersing them in a tub of water for a bit, and then exposing them to six intensities of UVB light from a sun simulator for a standard period of time. The skin patches were examined the next day for redness and the measured SPF was used to calculate the UVB scores.
For UVA, Consumer Reports conducted a critical wavelength test similar to what the Food and Drug Administration requires of manufacturers. The test assesses how well UV rays are absorbed by clear plastic plates that have been treated with the sunscreen.
The overall performance score was based on both the UVA and UVB results.
Among lotions, the best-performing product was Coppertone’s Water Babies SPF 50. Walmart’s less-expensive Equate Ultra Protection SPF 50 was the second-best performer. BullFrog’s WaterArmor Sport InstaCool SPF 50-plus was the top performing spray, followed by Target’s Up & Up Sport SPF 50. Banana Boat Ultra Defense Max Skin Protect SPF 110 spray and Neutrogena Ultimate Sport SPF 70-plus lotion were the highest-performing products with ultra-high SPFs.
The article and ratings are available online to subscribers and will be published in the group’s July 2014 print publication, Consumer Reports.
On Twitter @aliciaault
Feds award $110 million for innovative care models
The Department of Health & Human Services says it is giving some $110 million to health care organizations that have come up with innovative ways to deliver high-quality care at lower cost.
The federal grants will last for 3 years and are part of the Health Care Innovation Awards program created by the Affordable Care Act and administered by the innovation center at the Centers for Medicare & Medicaid Services.
Last May, the department announced that it was seeking applicants for as much as $1 billion in federal money for the projects.
In addition to the $110 million awarded to 12 health care organizations, the agency is making $730 million available to states seeking to "design and test improvements to their public and private health care payment and delivery systems," according to a Health & Human Services (HHS) department press release. That money has not yet been awarded.
The 12 current recipients of the Health Care Innovation Awards, profiled here, are the Altarum Institute; American College of Cardiology Foundation; Association of American Medical Colleges; Avera Health; Children’s Home Society of Florida; Clifford W. Beers Guidance Clinic; Four Seasons Compassion for Life; Icahn School of Medicine at Mount Sinai; New York City Health and Hospitals Corporation; North Shore LIJ Health System; Regents of the University of California, San Francisco; and Regents of the University of Michigan.
Additional recipients will be announced in the coming months.
Projects funded include ways to provide better care for dementia patients, to improve coordination between specialists and primary care physicians, and to ensure that children in Medicaid and the Children’s Health Insurance Program get more rapid attention to dental problems.
The American College of Cardiology Foundation received one of the biggest grants – $15.8 million – for its project, called SMARTCare. The project will use a combination of clinical decision support, shared decision-making, patient engagement, and provider feedback tools designed to improve care for stable ischemic heart disease. Among the goals: a reduction of imaging procedures not meeting appropriate use criteria; a reduction in the percentage of percutaneous coronary interventions not meeting appropriate use criteria while achieving high levels of patient engagement and lower rates of complications; and an increase in the percentage of stable ischemic heart disease patients with optimal risk factor modification.
The ACC will test SMARTCare at five sites in Wisconsin and five sites in Florida. It was developed by cardiologists who belong to those states’ ACC chapters, along with other physicians at health systems and in primary care, payers and insurers, employer health coalitions, patient advisers, and payment reform advisers.
The SMARTCare goals are big, "but we have the right people at the table to make them a reality," said Dr. Thomas Lewandowski, SMARTCare project director and immediate past governor of the ACC’s Wisconsin Chapter, in a statement.
"We believe involving patients in an evidence-based decision-making process is the best way to improve outcomes while providing the highest value for the health care dollar," said ACC President Patrick T. O’Gara, in the statement. "This grant will give us an opportunity to demonstrate how data from clinical registries can be leveraged to enhance physician/patient communication," he said.
The biggest award, about $18 million, went to the New York City Health and Hospitals Corporation, to test out an Emergency Department Care Management model. Six hospitals will expand upon a pilot program that uses multidisciplinary teams to assess ED patients; create a care plan to avoid unnecessary hospitalization; and provide ongoing support after discharge, including medication management, education, and linkages with primary care providers.
The agency says there was great interest in the latest round of awards, but it could not say how many organizations had applied. For the first round, in which awards were given out in 2012, there were 3,000 applicants, and 107 winners.
The Center for Medicare & Medicaid Innovation (CMMI) has the authority to expand any program nationally if it looks like it is producing savings.
HHS also is making $730 million available under the State Innovation Models Initiative to states that apply for the funds.
"As a former governor, I understand the real sense of urgency states and local communities feel to improve the health of their populations while also reducing health care costs, and it’s critical that the many elements of health care in each state – including Medicaid, public health, and workforce training – work together," said HHS Secretary Kathleen Sebelius in a statement. "To help, HHS will continue to encourage and assist them in their efforts to transform health care."
The states can apply for either a Model Test award to assist in implementation or a Model Design award to develop or enhance a comprehensive State Health Care Innovation Plan. Up to 12 states will be chosen for Model Test awards, and up to 15 will be chosen for Model Design awards.
HHS said that current examples of state-led health innovations include development of advanced primary care networks supported by statewide health information technology systems, and models that coordinate care seamlessly across providers.
[email protected]
On Twitter @aliciaault
The Department of Health & Human Services says it is giving some $110 million to health care organizations that have come up with innovative ways to deliver high-quality care at lower cost.
The federal grants will last for 3 years and are part of the Health Care Innovation Awards program created by the Affordable Care Act and administered by the innovation center at the Centers for Medicare & Medicaid Services.
Last May, the department announced that it was seeking applicants for as much as $1 billion in federal money for the projects.
In addition to the $110 million awarded to 12 health care organizations, the agency is making $730 million available to states seeking to "design and test improvements to their public and private health care payment and delivery systems," according to a Health & Human Services (HHS) department press release. That money has not yet been awarded.
The 12 current recipients of the Health Care Innovation Awards, profiled here, are the Altarum Institute; American College of Cardiology Foundation; Association of American Medical Colleges; Avera Health; Children’s Home Society of Florida; Clifford W. Beers Guidance Clinic; Four Seasons Compassion for Life; Icahn School of Medicine at Mount Sinai; New York City Health and Hospitals Corporation; North Shore LIJ Health System; Regents of the University of California, San Francisco; and Regents of the University of Michigan.
Additional recipients will be announced in the coming months.
Projects funded include ways to provide better care for dementia patients, to improve coordination between specialists and primary care physicians, and to ensure that children in Medicaid and the Children’s Health Insurance Program get more rapid attention to dental problems.
The American College of Cardiology Foundation received one of the biggest grants – $15.8 million – for its project, called SMARTCare. The project will use a combination of clinical decision support, shared decision-making, patient engagement, and provider feedback tools designed to improve care for stable ischemic heart disease. Among the goals: a reduction of imaging procedures not meeting appropriate use criteria; a reduction in the percentage of percutaneous coronary interventions not meeting appropriate use criteria while achieving high levels of patient engagement and lower rates of complications; and an increase in the percentage of stable ischemic heart disease patients with optimal risk factor modification.
The ACC will test SMARTCare at five sites in Wisconsin and five sites in Florida. It was developed by cardiologists who belong to those states’ ACC chapters, along with other physicians at health systems and in primary care, payers and insurers, employer health coalitions, patient advisers, and payment reform advisers.
The SMARTCare goals are big, "but we have the right people at the table to make them a reality," said Dr. Thomas Lewandowski, SMARTCare project director and immediate past governor of the ACC’s Wisconsin Chapter, in a statement.
"We believe involving patients in an evidence-based decision-making process is the best way to improve outcomes while providing the highest value for the health care dollar," said ACC President Patrick T. O’Gara, in the statement. "This grant will give us an opportunity to demonstrate how data from clinical registries can be leveraged to enhance physician/patient communication," he said.
The biggest award, about $18 million, went to the New York City Health and Hospitals Corporation, to test out an Emergency Department Care Management model. Six hospitals will expand upon a pilot program that uses multidisciplinary teams to assess ED patients; create a care plan to avoid unnecessary hospitalization; and provide ongoing support after discharge, including medication management, education, and linkages with primary care providers.
The agency says there was great interest in the latest round of awards, but it could not say how many organizations had applied. For the first round, in which awards were given out in 2012, there were 3,000 applicants, and 107 winners.
The Center for Medicare & Medicaid Innovation (CMMI) has the authority to expand any program nationally if it looks like it is producing savings.
HHS also is making $730 million available under the State Innovation Models Initiative to states that apply for the funds.
"As a former governor, I understand the real sense of urgency states and local communities feel to improve the health of their populations while also reducing health care costs, and it’s critical that the many elements of health care in each state – including Medicaid, public health, and workforce training – work together," said HHS Secretary Kathleen Sebelius in a statement. "To help, HHS will continue to encourage and assist them in their efforts to transform health care."
The states can apply for either a Model Test award to assist in implementation or a Model Design award to develop or enhance a comprehensive State Health Care Innovation Plan. Up to 12 states will be chosen for Model Test awards, and up to 15 will be chosen for Model Design awards.
HHS said that current examples of state-led health innovations include development of advanced primary care networks supported by statewide health information technology systems, and models that coordinate care seamlessly across providers.
[email protected]
On Twitter @aliciaault
The Department of Health & Human Services says it is giving some $110 million to health care organizations that have come up with innovative ways to deliver high-quality care at lower cost.
The federal grants will last for 3 years and are part of the Health Care Innovation Awards program created by the Affordable Care Act and administered by the innovation center at the Centers for Medicare & Medicaid Services.
Last May, the department announced that it was seeking applicants for as much as $1 billion in federal money for the projects.
In addition to the $110 million awarded to 12 health care organizations, the agency is making $730 million available to states seeking to "design and test improvements to their public and private health care payment and delivery systems," according to a Health & Human Services (HHS) department press release. That money has not yet been awarded.
The 12 current recipients of the Health Care Innovation Awards, profiled here, are the Altarum Institute; American College of Cardiology Foundation; Association of American Medical Colleges; Avera Health; Children’s Home Society of Florida; Clifford W. Beers Guidance Clinic; Four Seasons Compassion for Life; Icahn School of Medicine at Mount Sinai; New York City Health and Hospitals Corporation; North Shore LIJ Health System; Regents of the University of California, San Francisco; and Regents of the University of Michigan.
Additional recipients will be announced in the coming months.
Projects funded include ways to provide better care for dementia patients, to improve coordination between specialists and primary care physicians, and to ensure that children in Medicaid and the Children’s Health Insurance Program get more rapid attention to dental problems.
The American College of Cardiology Foundation received one of the biggest grants – $15.8 million – for its project, called SMARTCare. The project will use a combination of clinical decision support, shared decision-making, patient engagement, and provider feedback tools designed to improve care for stable ischemic heart disease. Among the goals: a reduction of imaging procedures not meeting appropriate use criteria; a reduction in the percentage of percutaneous coronary interventions not meeting appropriate use criteria while achieving high levels of patient engagement and lower rates of complications; and an increase in the percentage of stable ischemic heart disease patients with optimal risk factor modification.
The ACC will test SMARTCare at five sites in Wisconsin and five sites in Florida. It was developed by cardiologists who belong to those states’ ACC chapters, along with other physicians at health systems and in primary care, payers and insurers, employer health coalitions, patient advisers, and payment reform advisers.
The SMARTCare goals are big, "but we have the right people at the table to make them a reality," said Dr. Thomas Lewandowski, SMARTCare project director and immediate past governor of the ACC’s Wisconsin Chapter, in a statement.
"We believe involving patients in an evidence-based decision-making process is the best way to improve outcomes while providing the highest value for the health care dollar," said ACC President Patrick T. O’Gara, in the statement. "This grant will give us an opportunity to demonstrate how data from clinical registries can be leveraged to enhance physician/patient communication," he said.
The biggest award, about $18 million, went to the New York City Health and Hospitals Corporation, to test out an Emergency Department Care Management model. Six hospitals will expand upon a pilot program that uses multidisciplinary teams to assess ED patients; create a care plan to avoid unnecessary hospitalization; and provide ongoing support after discharge, including medication management, education, and linkages with primary care providers.
The agency says there was great interest in the latest round of awards, but it could not say how many organizations had applied. For the first round, in which awards were given out in 2012, there were 3,000 applicants, and 107 winners.
The Center for Medicare & Medicaid Innovation (CMMI) has the authority to expand any program nationally if it looks like it is producing savings.
HHS also is making $730 million available under the State Innovation Models Initiative to states that apply for the funds.
"As a former governor, I understand the real sense of urgency states and local communities feel to improve the health of their populations while also reducing health care costs, and it’s critical that the many elements of health care in each state – including Medicaid, public health, and workforce training – work together," said HHS Secretary Kathleen Sebelius in a statement. "To help, HHS will continue to encourage and assist them in their efforts to transform health care."
The states can apply for either a Model Test award to assist in implementation or a Model Design award to develop or enhance a comprehensive State Health Care Innovation Plan. Up to 12 states will be chosen for Model Test awards, and up to 15 will be chosen for Model Design awards.
HHS said that current examples of state-led health innovations include development of advanced primary care networks supported by statewide health information technology systems, and models that coordinate care seamlessly across providers.
[email protected]
On Twitter @aliciaault
Senate committee approves Burwell to head HHS
President Obama’s choice to be the new Secretary of the Department of Health & Human Services moved one step closer to that position with a Senate panel voting in favor of the nominee.
The Senate Finance Committee voted 21-3 May 21 to approve Sylvia Mathews Burwell as the new chief of HHS. She will replace Kathleen Sebelius, who has said she will step down when there is a new secretary in place.
"Ms. Burwell is highly qualified and well respected by Democrats and Republicans in government and in the private sector," said Sen. Ron Wyden (D-Ore.), chairman of the Finance Committee. "My view is that she will hit the ground running at the Department of Health & Human Services," he said.
At a Finance Committee hearing May 14, Ms. Burwell promised to be responsive to Congress, particularly in addressing issues related to the Affordable Care Act. She also said she was eager to work on a replacement for Medicare’s Sustainable Growth Rate factor.
Ms. Burwell is currently the director of the White House Office of Management and Budget.
Sen. Johnny Isakson (R-Ga.) said that at that earlier hearing, he found Ms. Burwell to be "forthright, and she was honest." He added, "I didn’t support the Affordable Care Act, but I believe with her in place, we’ll get answers to questions when they are asked, we’ll get accountability and honesty in the management of the department, and that’s a step in the right direction."
He said that he would vote for Ms. Burwell when the full Senate took up her nomination.
"I think we have a chance at having a really great administrator," said Sen. Orrin Hatch (R-Utah) of Ms. Burwell. "I very much support her."
Three Republican committee members voted against the nomination: Pat Roberts (Kan.), John Cornyn (Texas), and John Thune (S.D.).
The full Senate likely will vote on her nomination soon, possibly before the Senate recesses for a week beginning May 23.
On Twitter @aliciaault
President Obama’s choice to be the new Secretary of the Department of Health & Human Services moved one step closer to that position with a Senate panel voting in favor of the nominee.
The Senate Finance Committee voted 21-3 May 21 to approve Sylvia Mathews Burwell as the new chief of HHS. She will replace Kathleen Sebelius, who has said she will step down when there is a new secretary in place.
"Ms. Burwell is highly qualified and well respected by Democrats and Republicans in government and in the private sector," said Sen. Ron Wyden (D-Ore.), chairman of the Finance Committee. "My view is that she will hit the ground running at the Department of Health & Human Services," he said.
At a Finance Committee hearing May 14, Ms. Burwell promised to be responsive to Congress, particularly in addressing issues related to the Affordable Care Act. She also said she was eager to work on a replacement for Medicare’s Sustainable Growth Rate factor.
Ms. Burwell is currently the director of the White House Office of Management and Budget.
Sen. Johnny Isakson (R-Ga.) said that at that earlier hearing, he found Ms. Burwell to be "forthright, and she was honest." He added, "I didn’t support the Affordable Care Act, but I believe with her in place, we’ll get answers to questions when they are asked, we’ll get accountability and honesty in the management of the department, and that’s a step in the right direction."
He said that he would vote for Ms. Burwell when the full Senate took up her nomination.
"I think we have a chance at having a really great administrator," said Sen. Orrin Hatch (R-Utah) of Ms. Burwell. "I very much support her."
Three Republican committee members voted against the nomination: Pat Roberts (Kan.), John Cornyn (Texas), and John Thune (S.D.).
The full Senate likely will vote on her nomination soon, possibly before the Senate recesses for a week beginning May 23.
On Twitter @aliciaault
President Obama’s choice to be the new Secretary of the Department of Health & Human Services moved one step closer to that position with a Senate panel voting in favor of the nominee.
The Senate Finance Committee voted 21-3 May 21 to approve Sylvia Mathews Burwell as the new chief of HHS. She will replace Kathleen Sebelius, who has said she will step down when there is a new secretary in place.
"Ms. Burwell is highly qualified and well respected by Democrats and Republicans in government and in the private sector," said Sen. Ron Wyden (D-Ore.), chairman of the Finance Committee. "My view is that she will hit the ground running at the Department of Health & Human Services," he said.
At a Finance Committee hearing May 14, Ms. Burwell promised to be responsive to Congress, particularly in addressing issues related to the Affordable Care Act. She also said she was eager to work on a replacement for Medicare’s Sustainable Growth Rate factor.
Ms. Burwell is currently the director of the White House Office of Management and Budget.
Sen. Johnny Isakson (R-Ga.) said that at that earlier hearing, he found Ms. Burwell to be "forthright, and she was honest." He added, "I didn’t support the Affordable Care Act, but I believe with her in place, we’ll get answers to questions when they are asked, we’ll get accountability and honesty in the management of the department, and that’s a step in the right direction."
He said that he would vote for Ms. Burwell when the full Senate took up her nomination.
"I think we have a chance at having a really great administrator," said Sen. Orrin Hatch (R-Utah) of Ms. Burwell. "I very much support her."
Three Republican committee members voted against the nomination: Pat Roberts (Kan.), John Cornyn (Texas), and John Thune (S.D.).
The full Senate likely will vote on her nomination soon, possibly before the Senate recesses for a week beginning May 23.
On Twitter @aliciaault
Consumer Reports: Sunscreen SPF claims largely inaccurate
An analysis of 20 sunscreens by Consumer Reports found that only two provided the SPF protection claimed on the label.
The analysis – and rating of overall performance of those sunscreens – was released by the advocacy organization just ahead of Memorial Day weekend, the unofficial start of summer.
According to a survey of 1,000 adults conducted by the Consumer Reports National Research Center, a product’s sun protection factor (SPF) was the most important factor in determining what sunscreen to purchase.
Consumer Reports decided to put those SPF claims to the test in its own labs. The only two that tested at the SPF level claimed were BullFrog WaterArmor Sport InstaCool SPF 50-plus and Coppertone Sensitive Skin SPF 50. One product, Beyond Coastal Natural SPF 30, tested at half its claim. The other products tested at 4%-40% below the claimed SPF.
"We can’t say why our test results differ from the manufacturers’ claims, but they show that SPF isn’t always carved in stone," the Consumer Reports authors wrote.
The group also debunked some of what it called the "myths" about sunscreens, including that sprays provide the best coverage, and that "natural" sunscreens are safer than other sunscreens. In addition, mineral-based sunscreens are no more effective than other sunscreens, says Consumer Reports.
Also, the article said that there is no practical or meaningful difference between a sunscreen labeled for children and one for adults. In most cases, the active ingredients and the concentration of those ingredients are exactly the same. Some of the kids’ sunscreens contain only zinc oxide or titanium dioxide, which may be less irritating than products that contain chemical sunscreens such as avobenzone, according to the article.
The organization tested UVB protection by spreading a standard amount of sunscreen on a volunteer’s back, immersing them in a tub of water for a bit, and then exposing them to six intensities of UVB light from a sun simulator for a standard period of time. The skin patches were examined the next day for redness and the measured SPF was used to calculate the UVB scores.
For UVA, Consumer Reports conducted a critical wavelength test similar to what the Food and Drug Administration requires of manufacturers. The test assesses how well UV rays are absorbed by clear plastic plates that have been treated with the sunscreen.
The overall performance score was based on both the UVA and UVB results.
Among lotions, the best-performing product was Coppertone’s Water Babies SPF 50. Walmart’s less-expensive Equate Ultra Protection SPF 50 was the second-best performer. BullFrog’s WaterArmor Sport InstaCool SPF 50-plus was the top performing spray, followed by Target’s Up & Up Sport SPF 50. Banana Boat Ultra Defense Max Skin Protect SPF 110 spray and Neutrogena Ultimate Sport SPF 70-plus lotion were the highest-performing products with ultra-high SPFs.
The article and ratings are available online to subscribers and will be published in the group’s July 2014 print publication, Consumer Reports.
On Twitter @aliciaault
An analysis of 20 sunscreens by Consumer Reports found that only two provided the SPF protection claimed on the label.
The analysis – and rating of overall performance of those sunscreens – was released by the advocacy organization just ahead of Memorial Day weekend, the unofficial start of summer.
According to a survey of 1,000 adults conducted by the Consumer Reports National Research Center, a product’s sun protection factor (SPF) was the most important factor in determining what sunscreen to purchase.
Consumer Reports decided to put those SPF claims to the test in its own labs. The only two that tested at the SPF level claimed were BullFrog WaterArmor Sport InstaCool SPF 50-plus and Coppertone Sensitive Skin SPF 50. One product, Beyond Coastal Natural SPF 30, tested at half its claim. The other products tested at 4%-40% below the claimed SPF.
"We can’t say why our test results differ from the manufacturers’ claims, but they show that SPF isn’t always carved in stone," the Consumer Reports authors wrote.
The group also debunked some of what it called the "myths" about sunscreens, including that sprays provide the best coverage, and that "natural" sunscreens are safer than other sunscreens. In addition, mineral-based sunscreens are no more effective than other sunscreens, says Consumer Reports.
Also, the article said that there is no practical or meaningful difference between a sunscreen labeled for children and one for adults. In most cases, the active ingredients and the concentration of those ingredients are exactly the same. Some of the kids’ sunscreens contain only zinc oxide or titanium dioxide, which may be less irritating than products that contain chemical sunscreens such as avobenzone, according to the article.
The organization tested UVB protection by spreading a standard amount of sunscreen on a volunteer’s back, immersing them in a tub of water for a bit, and then exposing them to six intensities of UVB light from a sun simulator for a standard period of time. The skin patches were examined the next day for redness and the measured SPF was used to calculate the UVB scores.
For UVA, Consumer Reports conducted a critical wavelength test similar to what the Food and Drug Administration requires of manufacturers. The test assesses how well UV rays are absorbed by clear plastic plates that have been treated with the sunscreen.
The overall performance score was based on both the UVA and UVB results.
Among lotions, the best-performing product was Coppertone’s Water Babies SPF 50. Walmart’s less-expensive Equate Ultra Protection SPF 50 was the second-best performer. BullFrog’s WaterArmor Sport InstaCool SPF 50-plus was the top performing spray, followed by Target’s Up & Up Sport SPF 50. Banana Boat Ultra Defense Max Skin Protect SPF 110 spray and Neutrogena Ultimate Sport SPF 70-plus lotion were the highest-performing products with ultra-high SPFs.
The article and ratings are available online to subscribers and will be published in the group’s July 2014 print publication, Consumer Reports.
On Twitter @aliciaault
An analysis of 20 sunscreens by Consumer Reports found that only two provided the SPF protection claimed on the label.
The analysis – and rating of overall performance of those sunscreens – was released by the advocacy organization just ahead of Memorial Day weekend, the unofficial start of summer.
According to a survey of 1,000 adults conducted by the Consumer Reports National Research Center, a product’s sun protection factor (SPF) was the most important factor in determining what sunscreen to purchase.
Consumer Reports decided to put those SPF claims to the test in its own labs. The only two that tested at the SPF level claimed were BullFrog WaterArmor Sport InstaCool SPF 50-plus and Coppertone Sensitive Skin SPF 50. One product, Beyond Coastal Natural SPF 30, tested at half its claim. The other products tested at 4%-40% below the claimed SPF.
"We can’t say why our test results differ from the manufacturers’ claims, but they show that SPF isn’t always carved in stone," the Consumer Reports authors wrote.
The group also debunked some of what it called the "myths" about sunscreens, including that sprays provide the best coverage, and that "natural" sunscreens are safer than other sunscreens. In addition, mineral-based sunscreens are no more effective than other sunscreens, says Consumer Reports.
Also, the article said that there is no practical or meaningful difference between a sunscreen labeled for children and one for adults. In most cases, the active ingredients and the concentration of those ingredients are exactly the same. Some of the kids’ sunscreens contain only zinc oxide or titanium dioxide, which may be less irritating than products that contain chemical sunscreens such as avobenzone, according to the article.
The organization tested UVB protection by spreading a standard amount of sunscreen on a volunteer’s back, immersing them in a tub of water for a bit, and then exposing them to six intensities of UVB light from a sun simulator for a standard period of time. The skin patches were examined the next day for redness and the measured SPF was used to calculate the UVB scores.
For UVA, Consumer Reports conducted a critical wavelength test similar to what the Food and Drug Administration requires of manufacturers. The test assesses how well UV rays are absorbed by clear plastic plates that have been treated with the sunscreen.
The overall performance score was based on both the UVA and UVB results.
Among lotions, the best-performing product was Coppertone’s Water Babies SPF 50. Walmart’s less-expensive Equate Ultra Protection SPF 50 was the second-best performer. BullFrog’s WaterArmor Sport InstaCool SPF 50-plus was the top performing spray, followed by Target’s Up & Up Sport SPF 50. Banana Boat Ultra Defense Max Skin Protect SPF 110 spray and Neutrogena Ultimate Sport SPF 70-plus lotion were the highest-performing products with ultra-high SPFs.
The article and ratings are available online to subscribers and will be published in the group’s July 2014 print publication, Consumer Reports.
On Twitter @aliciaault
Oncology community scrutinizing obstacles to personalized medicine
Personalized medicine is a reality for many cancer patients, and getting closer for others, but the oncology community is struggling with a number of questions surrounding genomic testing, a key to providing that care.
As a result, oncology leaders have started to take a closer look at how to resolve these issues, and how to do it as quickly as possible.
Among the most basic questions are when to use the testing, what to do with the information that’s generated, and how to secure reimbursement for diagnostics that may not have fully proven their clinical utility.
The science of genomics – from profiling a tumor’s genetic make-up to sequencing a cancer patient’s entire genome – is growing exponentially, leading to a rush to commercialize diagnostics based on the discoveries and a push among big cancer centers to leverage the knowledge to help develop therapeutics and inform clinical trials. Meanwhile, the Food and Drug Administration hasn’t articulated a clear regulatory strategy around genomic testing.
"We need an infrastructure in place that quickly translates verified advances in treatment into practice," said Mark Fleury, Ph.D., of the American Cancer Society Cancer Action Network (ACS CAN). Now, genomic advances are relying on what he calls "passive diffusion."
Currently, there’s a kind of free-for-all, agreed Dr. Richard L. Schilsky, medical director of the American Society of Clinical Oncology.
"People need tests to guide treatment decisions, but there are very few controls over how tests are offered and developed," said Dr. Schilsky. He also noted that there is not a huge evidence base yet on the usefulness of some of the testing.
The oncology community is trying to bring some civility to the "Wild West" of genomics, starting by establishing standards, Dr. Schilsky said.
Among the issues being discussed:
• What genetic variants should oncologists be testing for in all common cancers?
• What is level of evidence that supports testing for those particular variants?
• What are the recommended clinical actions to be taken once certain variants are discovered?
• What information should be reported to the oncologist?
• What information should be reported to the patient, and how?
In early April, ASCO convened a meeting of representatives from clinical oncology, pathology, the genetic sequencing community, and the regulatory community, among others, to discuss those issues and more, Dr. Schilsky said. "We didn’t come away with any consensus, but we put all the issues on the table," he said.
ACS CAN held a policy forum in April to delve into some of the same issues.
"There are three main things you need to make personalized medicine work," said Dr. Fleury. The information generated has to be accurate, it has to somehow translate to having meaning for the disease, and the diagnostic has to provide some sort of change in treatment for the better, said Dr. Fleury. Now, though, "there are breakdowns in all three of those steps."
Understandably, said Dr. Fleury, payers don’t want to reimburse for tests or services that don’t provide any measurable utility. And, he said, the patient won’t want the information if he or she "doesn’t understand the usefulness."
Dr. Tanguy L. Seiwert of the department of medicine at the University of Chicago who focuses on head and neck and lung cancer, said, "Physicians want to do this, and there’s a growing movement that [genomic testing] is beneficial." But he added that the uncertainty over payment had helped contribute to an uncertainty overall about personalized medicine.
There’s not a lot of good data on exactly how many genomic tests are available – either as a single mutation test or a panel of tests – and how often they are being used.
The FDA has approved 19 diagnostics that are meant to help clinicians determine whether certain targeted therapies would be useful. They are used in colorectal, lung and breast cancers, gastrointestinal stromal tumors, and melanoma.
But that’s only a small fraction of the available tests. In July 2013, the Agency for Healthcare Research and Quality identified 178 different genetic tests for 10 common cancer conditions. Sixty-six were new since it last surveyed the field in 2011; the largest number of tests were being used for breast cancer.
The commercial potential of genomic testing is growing, despite the many outstanding questions. Myriad Genetics said in its most recent quarterly report that there was "wider acceptance of our molecular diagnostic tests by the medical community and increased patient testing volumes." Still, Myriad’s oncology testing revenues grew relatively slowly, by about 12% from the previous year to $102 million for the second quarter. Most of Myriad’s diagnostics are predictive, like its BRACAnalysis test. But the company is also branching out into genomics that will help guide treatment decisions.
In Oct. 2013, it launched the myPlan Lung Cancer test, which it says will help clinicians determine a newly diagnosed patient’s risk of dying from lung cancer within 5 years, and in turn help decide whether an early-stage patient should receive surgery alone or surgery plus adjuvant chemotherapy or radiation therapy.
Foundation Medicine, based in Cambridge, Mass., is working with drug makers to develop companion diagnostics for targeted chemotherapies but is also offering direct to oncologists genomic panels that provide analysis of up to 200 genes. One of the tests is for solid tumors and the other is for hematologic malignancies, sarcomas, and pediatric cancers. The company said in its most recent quarterly report that testing revenues had grown by a third from the year ago quarter.
The FDA is also approving new targeted therapies that would probably be made more useful through the use of genomic testing to winnow down the number of potential patients who could benefit. For instance, in May, the agency approved certinib (Zykadia), a drug that blocks the anaplastic lymphoma kinase (ALK) protein. There is an FDA-approved diagnostic – the Vysis ALK Break Apart FISH Probe Kit – designed to detect ALK gene mutations, but it’s indicated for use only to identify patients eligible for treatment with another therapy, crizotinib (Xalkori).
There’s nothing to stop off-label use, or use of so-called "home brew" tests that are developed in-house at hospitals or clinical labs but not FDA-approved.
The FDA may soon step up its regulation of those diagnostics, said ACS CAN’s Dr. Fleury. "They’ve been very public that they fully intend to bring high-risk lab tests into their purview," he said, adding that many in the field believe that the regulations have already been written. It appears that the only thing delaying those regulations from being issued is White House clearance, Dr. Fleury said.
Meanwhile, many institutions are moving on to next generation sequencing, which involves taking a look at hundreds of genes, not just a single variant. Even with a limited amount of tumor tissue, it maximizes the information that can be gleaned from a biopsy sample, said Dr. Schilsky. It may be less expensive and more efficient than conducting multiple different single mutation diagnostics, he said.
However, right now, "it gives you way more information than you could possibly use at any point in time," said Dr. Schilsky. And, many clinicians have difficulty interpreting such a huge amount of complex information.
Most payers are not approving reimbursement for these multiple gene panels, he said. Even so, "many cancer centers are doing this because they think it provides an important platform for their research, and it attracts patients to their institutions," said Dr. Schilsky.
Dr. Seiwert helped develop a multigene assay, which the University of Chicago recently began offering to its oncology patients. In general, it is not being covered by insurers, he said. But, while the cost of molecular diagnostics – which can run from $1,500-$8,000 per patient – is high, it is not that large when compared with the cost of many chemotherapies, he said. If the testing "leads to treatment that has a higher chance of working, then it’s a very small cost, compared with blindly using a drug," Dr. Seiwert said.
His cancer center is covering the cost of testing when it is not reimbursed. Dr. Schilsky said that, from what he has heard, that is not uncommon. "My understanding from many lab directors is that they are basically eating the costs," he said.
Partly because of economics, genomic testing has not disseminated out of the academic centers. Dr. Seiwert said that he thought that testing for specific mutations like EGFR in lung cancer or HER2 in breast cancer was becoming a standard of practice, but that it was a "moving target" in the community. And, when it comes to larger, multi-gene assays, "my sense is that this is largely confined to academic centers," he said.
Single mutation genomic testing, especially for lung cancer "should be the standard of care, but the evidence is that it has not permeated out to the smaller practices," said Dr. Fleury, of ACS CAN.
"When you come in, you should get the diagnosis and be tested for a mutation right away," said Dr. Fleury, who added that this is not happening on a widespread basis.
Oncologists can often be in an awkward position when a test they want to offer is not covered by the patient’s insurance. If the patient can’t afford the cost, they might feel like they’re not getting something that others can, said Dr. Seiwert. "It’s a messy situation," he said.
But, it’s one that oncologists at academic centers don’t have to encounter very often, as they usually find a way to cover the cost of testing.
"When it comes to genetic testing, we have both under- and over-utilization," said Dr. Fleury. "We need that happy medium."
Things will start evening out with the right infrastructure, Dr. Fleury said. He sees things falling into place with organizations like ASCO and ACS CAN developing guidelines and standards, and the FDA about to step up its oversight of genomic assays that are developed in-house by hospital and commercial labs.
Also, as the market evolves towards panels of tests, instead of just single mutations, the process will likely become more efficient, Dr. Fleury added.
Currently, for instance, there are only two targeted therapies and two companion diagnostics for lung cancer but a dozen known mutations. In the future, as more therapies are developed to go after those mutations, it won’t be cost-effective or efficient to conduct a dozen different tests with a dozen different charges and copays, said Dr. Fleury.
On Twitter @aliciaault
Personalized medicine is a reality for many cancer patients, and getting closer for others, but the oncology community is struggling with a number of questions surrounding genomic testing, a key to providing that care.
As a result, oncology leaders have started to take a closer look at how to resolve these issues, and how to do it as quickly as possible.
Among the most basic questions are when to use the testing, what to do with the information that’s generated, and how to secure reimbursement for diagnostics that may not have fully proven their clinical utility.
The science of genomics – from profiling a tumor’s genetic make-up to sequencing a cancer patient’s entire genome – is growing exponentially, leading to a rush to commercialize diagnostics based on the discoveries and a push among big cancer centers to leverage the knowledge to help develop therapeutics and inform clinical trials. Meanwhile, the Food and Drug Administration hasn’t articulated a clear regulatory strategy around genomic testing.
"We need an infrastructure in place that quickly translates verified advances in treatment into practice," said Mark Fleury, Ph.D., of the American Cancer Society Cancer Action Network (ACS CAN). Now, genomic advances are relying on what he calls "passive diffusion."
Currently, there’s a kind of free-for-all, agreed Dr. Richard L. Schilsky, medical director of the American Society of Clinical Oncology.
"People need tests to guide treatment decisions, but there are very few controls over how tests are offered and developed," said Dr. Schilsky. He also noted that there is not a huge evidence base yet on the usefulness of some of the testing.
The oncology community is trying to bring some civility to the "Wild West" of genomics, starting by establishing standards, Dr. Schilsky said.
Among the issues being discussed:
• What genetic variants should oncologists be testing for in all common cancers?
• What is level of evidence that supports testing for those particular variants?
• What are the recommended clinical actions to be taken once certain variants are discovered?
• What information should be reported to the oncologist?
• What information should be reported to the patient, and how?
In early April, ASCO convened a meeting of representatives from clinical oncology, pathology, the genetic sequencing community, and the regulatory community, among others, to discuss those issues and more, Dr. Schilsky said. "We didn’t come away with any consensus, but we put all the issues on the table," he said.
ACS CAN held a policy forum in April to delve into some of the same issues.
"There are three main things you need to make personalized medicine work," said Dr. Fleury. The information generated has to be accurate, it has to somehow translate to having meaning for the disease, and the diagnostic has to provide some sort of change in treatment for the better, said Dr. Fleury. Now, though, "there are breakdowns in all three of those steps."
Understandably, said Dr. Fleury, payers don’t want to reimburse for tests or services that don’t provide any measurable utility. And, he said, the patient won’t want the information if he or she "doesn’t understand the usefulness."
Dr. Tanguy L. Seiwert of the department of medicine at the University of Chicago who focuses on head and neck and lung cancer, said, "Physicians want to do this, and there’s a growing movement that [genomic testing] is beneficial." But he added that the uncertainty over payment had helped contribute to an uncertainty overall about personalized medicine.
There’s not a lot of good data on exactly how many genomic tests are available – either as a single mutation test or a panel of tests – and how often they are being used.
The FDA has approved 19 diagnostics that are meant to help clinicians determine whether certain targeted therapies would be useful. They are used in colorectal, lung and breast cancers, gastrointestinal stromal tumors, and melanoma.
But that’s only a small fraction of the available tests. In July 2013, the Agency for Healthcare Research and Quality identified 178 different genetic tests for 10 common cancer conditions. Sixty-six were new since it last surveyed the field in 2011; the largest number of tests were being used for breast cancer.
The commercial potential of genomic testing is growing, despite the many outstanding questions. Myriad Genetics said in its most recent quarterly report that there was "wider acceptance of our molecular diagnostic tests by the medical community and increased patient testing volumes." Still, Myriad’s oncology testing revenues grew relatively slowly, by about 12% from the previous year to $102 million for the second quarter. Most of Myriad’s diagnostics are predictive, like its BRACAnalysis test. But the company is also branching out into genomics that will help guide treatment decisions.
In Oct. 2013, it launched the myPlan Lung Cancer test, which it says will help clinicians determine a newly diagnosed patient’s risk of dying from lung cancer within 5 years, and in turn help decide whether an early-stage patient should receive surgery alone or surgery plus adjuvant chemotherapy or radiation therapy.
Foundation Medicine, based in Cambridge, Mass., is working with drug makers to develop companion diagnostics for targeted chemotherapies but is also offering direct to oncologists genomic panels that provide analysis of up to 200 genes. One of the tests is for solid tumors and the other is for hematologic malignancies, sarcomas, and pediatric cancers. The company said in its most recent quarterly report that testing revenues had grown by a third from the year ago quarter.
The FDA is also approving new targeted therapies that would probably be made more useful through the use of genomic testing to winnow down the number of potential patients who could benefit. For instance, in May, the agency approved certinib (Zykadia), a drug that blocks the anaplastic lymphoma kinase (ALK) protein. There is an FDA-approved diagnostic – the Vysis ALK Break Apart FISH Probe Kit – designed to detect ALK gene mutations, but it’s indicated for use only to identify patients eligible for treatment with another therapy, crizotinib (Xalkori).
There’s nothing to stop off-label use, or use of so-called "home brew" tests that are developed in-house at hospitals or clinical labs but not FDA-approved.
The FDA may soon step up its regulation of those diagnostics, said ACS CAN’s Dr. Fleury. "They’ve been very public that they fully intend to bring high-risk lab tests into their purview," he said, adding that many in the field believe that the regulations have already been written. It appears that the only thing delaying those regulations from being issued is White House clearance, Dr. Fleury said.
Meanwhile, many institutions are moving on to next generation sequencing, which involves taking a look at hundreds of genes, not just a single variant. Even with a limited amount of tumor tissue, it maximizes the information that can be gleaned from a biopsy sample, said Dr. Schilsky. It may be less expensive and more efficient than conducting multiple different single mutation diagnostics, he said.
However, right now, "it gives you way more information than you could possibly use at any point in time," said Dr. Schilsky. And, many clinicians have difficulty interpreting such a huge amount of complex information.
Most payers are not approving reimbursement for these multiple gene panels, he said. Even so, "many cancer centers are doing this because they think it provides an important platform for their research, and it attracts patients to their institutions," said Dr. Schilsky.
Dr. Seiwert helped develop a multigene assay, which the University of Chicago recently began offering to its oncology patients. In general, it is not being covered by insurers, he said. But, while the cost of molecular diagnostics – which can run from $1,500-$8,000 per patient – is high, it is not that large when compared with the cost of many chemotherapies, he said. If the testing "leads to treatment that has a higher chance of working, then it’s a very small cost, compared with blindly using a drug," Dr. Seiwert said.
His cancer center is covering the cost of testing when it is not reimbursed. Dr. Schilsky said that, from what he has heard, that is not uncommon. "My understanding from many lab directors is that they are basically eating the costs," he said.
Partly because of economics, genomic testing has not disseminated out of the academic centers. Dr. Seiwert said that he thought that testing for specific mutations like EGFR in lung cancer or HER2 in breast cancer was becoming a standard of practice, but that it was a "moving target" in the community. And, when it comes to larger, multi-gene assays, "my sense is that this is largely confined to academic centers," he said.
Single mutation genomic testing, especially for lung cancer "should be the standard of care, but the evidence is that it has not permeated out to the smaller practices," said Dr. Fleury, of ACS CAN.
"When you come in, you should get the diagnosis and be tested for a mutation right away," said Dr. Fleury, who added that this is not happening on a widespread basis.
Oncologists can often be in an awkward position when a test they want to offer is not covered by the patient’s insurance. If the patient can’t afford the cost, they might feel like they’re not getting something that others can, said Dr. Seiwert. "It’s a messy situation," he said.
But, it’s one that oncologists at academic centers don’t have to encounter very often, as they usually find a way to cover the cost of testing.
"When it comes to genetic testing, we have both under- and over-utilization," said Dr. Fleury. "We need that happy medium."
Things will start evening out with the right infrastructure, Dr. Fleury said. He sees things falling into place with organizations like ASCO and ACS CAN developing guidelines and standards, and the FDA about to step up its oversight of genomic assays that are developed in-house by hospital and commercial labs.
Also, as the market evolves towards panels of tests, instead of just single mutations, the process will likely become more efficient, Dr. Fleury added.
Currently, for instance, there are only two targeted therapies and two companion diagnostics for lung cancer but a dozen known mutations. In the future, as more therapies are developed to go after those mutations, it won’t be cost-effective or efficient to conduct a dozen different tests with a dozen different charges and copays, said Dr. Fleury.
On Twitter @aliciaault
Personalized medicine is a reality for many cancer patients, and getting closer for others, but the oncology community is struggling with a number of questions surrounding genomic testing, a key to providing that care.
As a result, oncology leaders have started to take a closer look at how to resolve these issues, and how to do it as quickly as possible.
Among the most basic questions are when to use the testing, what to do with the information that’s generated, and how to secure reimbursement for diagnostics that may not have fully proven their clinical utility.
The science of genomics – from profiling a tumor’s genetic make-up to sequencing a cancer patient’s entire genome – is growing exponentially, leading to a rush to commercialize diagnostics based on the discoveries and a push among big cancer centers to leverage the knowledge to help develop therapeutics and inform clinical trials. Meanwhile, the Food and Drug Administration hasn’t articulated a clear regulatory strategy around genomic testing.
"We need an infrastructure in place that quickly translates verified advances in treatment into practice," said Mark Fleury, Ph.D., of the American Cancer Society Cancer Action Network (ACS CAN). Now, genomic advances are relying on what he calls "passive diffusion."
Currently, there’s a kind of free-for-all, agreed Dr. Richard L. Schilsky, medical director of the American Society of Clinical Oncology.
"People need tests to guide treatment decisions, but there are very few controls over how tests are offered and developed," said Dr. Schilsky. He also noted that there is not a huge evidence base yet on the usefulness of some of the testing.
The oncology community is trying to bring some civility to the "Wild West" of genomics, starting by establishing standards, Dr. Schilsky said.
Among the issues being discussed:
• What genetic variants should oncologists be testing for in all common cancers?
• What is level of evidence that supports testing for those particular variants?
• What are the recommended clinical actions to be taken once certain variants are discovered?
• What information should be reported to the oncologist?
• What information should be reported to the patient, and how?
In early April, ASCO convened a meeting of representatives from clinical oncology, pathology, the genetic sequencing community, and the regulatory community, among others, to discuss those issues and more, Dr. Schilsky said. "We didn’t come away with any consensus, but we put all the issues on the table," he said.
ACS CAN held a policy forum in April to delve into some of the same issues.
"There are three main things you need to make personalized medicine work," said Dr. Fleury. The information generated has to be accurate, it has to somehow translate to having meaning for the disease, and the diagnostic has to provide some sort of change in treatment for the better, said Dr. Fleury. Now, though, "there are breakdowns in all three of those steps."
Understandably, said Dr. Fleury, payers don’t want to reimburse for tests or services that don’t provide any measurable utility. And, he said, the patient won’t want the information if he or she "doesn’t understand the usefulness."
Dr. Tanguy L. Seiwert of the department of medicine at the University of Chicago who focuses on head and neck and lung cancer, said, "Physicians want to do this, and there’s a growing movement that [genomic testing] is beneficial." But he added that the uncertainty over payment had helped contribute to an uncertainty overall about personalized medicine.
There’s not a lot of good data on exactly how many genomic tests are available – either as a single mutation test or a panel of tests – and how often they are being used.
The FDA has approved 19 diagnostics that are meant to help clinicians determine whether certain targeted therapies would be useful. They are used in colorectal, lung and breast cancers, gastrointestinal stromal tumors, and melanoma.
But that’s only a small fraction of the available tests. In July 2013, the Agency for Healthcare Research and Quality identified 178 different genetic tests for 10 common cancer conditions. Sixty-six were new since it last surveyed the field in 2011; the largest number of tests were being used for breast cancer.
The commercial potential of genomic testing is growing, despite the many outstanding questions. Myriad Genetics said in its most recent quarterly report that there was "wider acceptance of our molecular diagnostic tests by the medical community and increased patient testing volumes." Still, Myriad’s oncology testing revenues grew relatively slowly, by about 12% from the previous year to $102 million for the second quarter. Most of Myriad’s diagnostics are predictive, like its BRACAnalysis test. But the company is also branching out into genomics that will help guide treatment decisions.
In Oct. 2013, it launched the myPlan Lung Cancer test, which it says will help clinicians determine a newly diagnosed patient’s risk of dying from lung cancer within 5 years, and in turn help decide whether an early-stage patient should receive surgery alone or surgery plus adjuvant chemotherapy or radiation therapy.
Foundation Medicine, based in Cambridge, Mass., is working with drug makers to develop companion diagnostics for targeted chemotherapies but is also offering direct to oncologists genomic panels that provide analysis of up to 200 genes. One of the tests is for solid tumors and the other is for hematologic malignancies, sarcomas, and pediatric cancers. The company said in its most recent quarterly report that testing revenues had grown by a third from the year ago quarter.
The FDA is also approving new targeted therapies that would probably be made more useful through the use of genomic testing to winnow down the number of potential patients who could benefit. For instance, in May, the agency approved certinib (Zykadia), a drug that blocks the anaplastic lymphoma kinase (ALK) protein. There is an FDA-approved diagnostic – the Vysis ALK Break Apart FISH Probe Kit – designed to detect ALK gene mutations, but it’s indicated for use only to identify patients eligible for treatment with another therapy, crizotinib (Xalkori).
There’s nothing to stop off-label use, or use of so-called "home brew" tests that are developed in-house at hospitals or clinical labs but not FDA-approved.
The FDA may soon step up its regulation of those diagnostics, said ACS CAN’s Dr. Fleury. "They’ve been very public that they fully intend to bring high-risk lab tests into their purview," he said, adding that many in the field believe that the regulations have already been written. It appears that the only thing delaying those regulations from being issued is White House clearance, Dr. Fleury said.
Meanwhile, many institutions are moving on to next generation sequencing, which involves taking a look at hundreds of genes, not just a single variant. Even with a limited amount of tumor tissue, it maximizes the information that can be gleaned from a biopsy sample, said Dr. Schilsky. It may be less expensive and more efficient than conducting multiple different single mutation diagnostics, he said.
However, right now, "it gives you way more information than you could possibly use at any point in time," said Dr. Schilsky. And, many clinicians have difficulty interpreting such a huge amount of complex information.
Most payers are not approving reimbursement for these multiple gene panels, he said. Even so, "many cancer centers are doing this because they think it provides an important platform for their research, and it attracts patients to their institutions," said Dr. Schilsky.
Dr. Seiwert helped develop a multigene assay, which the University of Chicago recently began offering to its oncology patients. In general, it is not being covered by insurers, he said. But, while the cost of molecular diagnostics – which can run from $1,500-$8,000 per patient – is high, it is not that large when compared with the cost of many chemotherapies, he said. If the testing "leads to treatment that has a higher chance of working, then it’s a very small cost, compared with blindly using a drug," Dr. Seiwert said.
His cancer center is covering the cost of testing when it is not reimbursed. Dr. Schilsky said that, from what he has heard, that is not uncommon. "My understanding from many lab directors is that they are basically eating the costs," he said.
Partly because of economics, genomic testing has not disseminated out of the academic centers. Dr. Seiwert said that he thought that testing for specific mutations like EGFR in lung cancer or HER2 in breast cancer was becoming a standard of practice, but that it was a "moving target" in the community. And, when it comes to larger, multi-gene assays, "my sense is that this is largely confined to academic centers," he said.
Single mutation genomic testing, especially for lung cancer "should be the standard of care, but the evidence is that it has not permeated out to the smaller practices," said Dr. Fleury, of ACS CAN.
"When you come in, you should get the diagnosis and be tested for a mutation right away," said Dr. Fleury, who added that this is not happening on a widespread basis.
Oncologists can often be in an awkward position when a test they want to offer is not covered by the patient’s insurance. If the patient can’t afford the cost, they might feel like they’re not getting something that others can, said Dr. Seiwert. "It’s a messy situation," he said.
But, it’s one that oncologists at academic centers don’t have to encounter very often, as they usually find a way to cover the cost of testing.
"When it comes to genetic testing, we have both under- and over-utilization," said Dr. Fleury. "We need that happy medium."
Things will start evening out with the right infrastructure, Dr. Fleury said. He sees things falling into place with organizations like ASCO and ACS CAN developing guidelines and standards, and the FDA about to step up its oversight of genomic assays that are developed in-house by hospital and commercial labs.
Also, as the market evolves towards panels of tests, instead of just single mutations, the process will likely become more efficient, Dr. Fleury added.
Currently, for instance, there are only two targeted therapies and two companion diagnostics for lung cancer but a dozen known mutations. In the future, as more therapies are developed to go after those mutations, it won’t be cost-effective or efficient to conduct a dozen different tests with a dozen different charges and copays, said Dr. Fleury.
On Twitter @aliciaault
ABIM: Majority meeting Maintenance of Certification requirements
The American Board of Internal Medicine says that "a substantial majority" of the nation’s internists have met the new Maintenance of Certification requirements as of May 1, the deadline for doctors to be listed publicly on the ABIM’s website as having met those standards.
The ABIM reported that "despite vocal concerns" from physicians, some 150,000 have enrolled in the MOC program, 50,000 since the new requirements were instituted on Jan. 1.
As part of the new MOC, every 2 years, physicians who are certified by the ABIM must earn at least some points by completing some of the educational activities approved for MOC credit. At the 5-year mark, they must earn 100 points, as well as complete patient safety and patient survey activities, to be considered up to date. Previously, physicians were given 10 years to earn 100 points. They must also pass their board exam every 10 years.
"We are listening to the feedback we have received from the community about changes to our program, but at the same time the public is seeking a way to know that their doctor is ‘keeping up in their field,’" Dr. Richard Baron, ABIM president and chief executive officer, said in a statement.
A petition to overturn most of the MOC changes begun by Dr. Paul Teirstein, chief of cardiology and director of interventional cardiology for Scripps Clinic in La Jolla, Calif., has collected more than 14,000 signatures since it was posted in late March.
According to the ABIM, since Jan. 1, physicians have claimed more than 245,000 hours of Continuing Medical Education (CME) through their MOC involvement, and nearly 20,000 physicians have already met their MOC requirements through 2015.
"MOC has clearly sparked a national conversation focused on what regular assessments are appropriate for ongoing specialty certification," Dr. Baron said. "We must look at how the MOC process meets the needs of physicians, patients, and others who rely on it as an indicator of a provider’s expertise."
The ABIM continues to say that MOC is needed because it is desired by patients and payers. "Those who choose to meet ABIM’s MOC requirements are differentiating themselves from some of their colleagues. They are saying, ‘I’m a cardiologist or oncologist, or whatever specialty they are certified in, who is meeting a standard set by my peers.’ That is a powerful statement to make to their patients, and to themselves," Dr. Clarence H. Braddock III, chair-elect of the ABIM Board of Directors, said in the ABIM statement.
The Board also said it is responding to criticism by making changes to the MOC program, including giving "credit" for activities physicians already are doing to maintain their knowledge base and improve their practices. It said it recognizes more than 270 programs created by medical societies, health systems, and others and that 32,000 ABIM diplomates already have fulfilled some requirements of MOC using those pathways.
"We recognize that the MOC program is not perfect, and we are committed to constant assessment of it," said Dr. Baron.
That may not be enough for some physicians.
Another group, Change Board Recertification, was started in 2010 with the aim of completely overhauling the MOC process.
On Twitter @aliciaault
The new MOC requirements that became effective on Jan. 1, 2014, have met with significant criticism from practicing physicians. Nevertheless, the majority of physicians with time-limited board certifications have enrolled in the program, as hospital privileges and insurance reimbursements are often linked to active certification.
Whereas it is largely agreed that some measure of ongoing knowledge and competence is vital to setting standards for the profession and protecting the interests of patients, many physicians raise significant concerns regarding the current process. These include overly burdensome costs and time commitments as well as relevance to actual practice.
Finally, there is a paucity of data demonstrating that the MOC recertification process actually translates to improved physician performance in the clinical setting. A number of recommendations have been suggested to improve the recertification process. These include decreasing the costs of recertification by the ABIM; customizing the process to dovetail with an individual physician's actual practice; testing not only rote knowledge, but also physician ability to accesses and utilize information; and further research to demonstrate efficacy in achieving and demonstrating physician competence.
The new MOC requirements that became effective on Jan. 1, 2014, have met with significant criticism from practicing physicians. Nevertheless, the majority of physicians with time-limited board certifications have enrolled in the program, as hospital privileges and insurance reimbursements are often linked to active certification.
Whereas it is largely agreed that some measure of ongoing knowledge and competence is vital to setting standards for the profession and protecting the interests of patients, many physicians raise significant concerns regarding the current process. These include overly burdensome costs and time commitments as well as relevance to actual practice.
Finally, there is a paucity of data demonstrating that the MOC recertification process actually translates to improved physician performance in the clinical setting. A number of recommendations have been suggested to improve the recertification process. These include decreasing the costs of recertification by the ABIM; customizing the process to dovetail with an individual physician's actual practice; testing not only rote knowledge, but also physician ability to accesses and utilize information; and further research to demonstrate efficacy in achieving and demonstrating physician competence.
The new MOC requirements that became effective on Jan. 1, 2014, have met with significant criticism from practicing physicians. Nevertheless, the majority of physicians with time-limited board certifications have enrolled in the program, as hospital privileges and insurance reimbursements are often linked to active certification.
Whereas it is largely agreed that some measure of ongoing knowledge and competence is vital to setting standards for the profession and protecting the interests of patients, many physicians raise significant concerns regarding the current process. These include overly burdensome costs and time commitments as well as relevance to actual practice.
Finally, there is a paucity of data demonstrating that the MOC recertification process actually translates to improved physician performance in the clinical setting. A number of recommendations have been suggested to improve the recertification process. These include decreasing the costs of recertification by the ABIM; customizing the process to dovetail with an individual physician's actual practice; testing not only rote knowledge, but also physician ability to accesses and utilize information; and further research to demonstrate efficacy in achieving and demonstrating physician competence.
The American Board of Internal Medicine says that "a substantial majority" of the nation’s internists have met the new Maintenance of Certification requirements as of May 1, the deadline for doctors to be listed publicly on the ABIM’s website as having met those standards.
The ABIM reported that "despite vocal concerns" from physicians, some 150,000 have enrolled in the MOC program, 50,000 since the new requirements were instituted on Jan. 1.
As part of the new MOC, every 2 years, physicians who are certified by the ABIM must earn at least some points by completing some of the educational activities approved for MOC credit. At the 5-year mark, they must earn 100 points, as well as complete patient safety and patient survey activities, to be considered up to date. Previously, physicians were given 10 years to earn 100 points. They must also pass their board exam every 10 years.
"We are listening to the feedback we have received from the community about changes to our program, but at the same time the public is seeking a way to know that their doctor is ‘keeping up in their field,’" Dr. Richard Baron, ABIM president and chief executive officer, said in a statement.
A petition to overturn most of the MOC changes begun by Dr. Paul Teirstein, chief of cardiology and director of interventional cardiology for Scripps Clinic in La Jolla, Calif., has collected more than 14,000 signatures since it was posted in late March.
According to the ABIM, since Jan. 1, physicians have claimed more than 245,000 hours of Continuing Medical Education (CME) through their MOC involvement, and nearly 20,000 physicians have already met their MOC requirements through 2015.
"MOC has clearly sparked a national conversation focused on what regular assessments are appropriate for ongoing specialty certification," Dr. Baron said. "We must look at how the MOC process meets the needs of physicians, patients, and others who rely on it as an indicator of a provider’s expertise."
The ABIM continues to say that MOC is needed because it is desired by patients and payers. "Those who choose to meet ABIM’s MOC requirements are differentiating themselves from some of their colleagues. They are saying, ‘I’m a cardiologist or oncologist, or whatever specialty they are certified in, who is meeting a standard set by my peers.’ That is a powerful statement to make to their patients, and to themselves," Dr. Clarence H. Braddock III, chair-elect of the ABIM Board of Directors, said in the ABIM statement.
The Board also said it is responding to criticism by making changes to the MOC program, including giving "credit" for activities physicians already are doing to maintain their knowledge base and improve their practices. It said it recognizes more than 270 programs created by medical societies, health systems, and others and that 32,000 ABIM diplomates already have fulfilled some requirements of MOC using those pathways.
"We recognize that the MOC program is not perfect, and we are committed to constant assessment of it," said Dr. Baron.
That may not be enough for some physicians.
Another group, Change Board Recertification, was started in 2010 with the aim of completely overhauling the MOC process.
On Twitter @aliciaault
The American Board of Internal Medicine says that "a substantial majority" of the nation’s internists have met the new Maintenance of Certification requirements as of May 1, the deadline for doctors to be listed publicly on the ABIM’s website as having met those standards.
The ABIM reported that "despite vocal concerns" from physicians, some 150,000 have enrolled in the MOC program, 50,000 since the new requirements were instituted on Jan. 1.
As part of the new MOC, every 2 years, physicians who are certified by the ABIM must earn at least some points by completing some of the educational activities approved for MOC credit. At the 5-year mark, they must earn 100 points, as well as complete patient safety and patient survey activities, to be considered up to date. Previously, physicians were given 10 years to earn 100 points. They must also pass their board exam every 10 years.
"We are listening to the feedback we have received from the community about changes to our program, but at the same time the public is seeking a way to know that their doctor is ‘keeping up in their field,’" Dr. Richard Baron, ABIM president and chief executive officer, said in a statement.
A petition to overturn most of the MOC changes begun by Dr. Paul Teirstein, chief of cardiology and director of interventional cardiology for Scripps Clinic in La Jolla, Calif., has collected more than 14,000 signatures since it was posted in late March.
According to the ABIM, since Jan. 1, physicians have claimed more than 245,000 hours of Continuing Medical Education (CME) through their MOC involvement, and nearly 20,000 physicians have already met their MOC requirements through 2015.
"MOC has clearly sparked a national conversation focused on what regular assessments are appropriate for ongoing specialty certification," Dr. Baron said. "We must look at how the MOC process meets the needs of physicians, patients, and others who rely on it as an indicator of a provider’s expertise."
The ABIM continues to say that MOC is needed because it is desired by patients and payers. "Those who choose to meet ABIM’s MOC requirements are differentiating themselves from some of their colleagues. They are saying, ‘I’m a cardiologist or oncologist, or whatever specialty they are certified in, who is meeting a standard set by my peers.’ That is a powerful statement to make to their patients, and to themselves," Dr. Clarence H. Braddock III, chair-elect of the ABIM Board of Directors, said in the ABIM statement.
The Board also said it is responding to criticism by making changes to the MOC program, including giving "credit" for activities physicians already are doing to maintain their knowledge base and improve their practices. It said it recognizes more than 270 programs created by medical societies, health systems, and others and that 32,000 ABIM diplomates already have fulfilled some requirements of MOC using those pathways.
"We recognize that the MOC program is not perfect, and we are committed to constant assessment of it," said Dr. Baron.
That may not be enough for some physicians.
Another group, Change Board Recertification, was started in 2010 with the aim of completely overhauling the MOC process.
On Twitter @aliciaault
Insurers address ACA 90-day grace period issue
Representatives of major insurance companies assured lawmakers that they have systems in place by which physicians can check whether patients newly insured through the state and federal health exchanges were up to date on payments for their premiums and thus eligible for coverage.
The insurers – Aetna, Cigna, Health Care Service Corporation, and Wellpoint – appeared May 7 before the House Energy and Commerce Oversight and Investigations Subcommittee to answer questions about how many enrollees under the Affordable Care Act’s state and federal health insurance exchanges have paid their premiums.
Rep. Michael Burgess (R-Tex.), a physician and a subcommittee member, said that he was especially concerned about the 90-day grace period that could create a situation in which care delivered by doctors is not covered by insurance companies.
The grace period was built into the Affordable Care Act.
According to the law, patients must pay their first month’s premium to be considered enrolled and verified as insured. After that, however, they have 90 days to pay the next premium. If the patient doesn’t pay for the second month, the insurer can hold or "pend" all claims. By the third month, if the patient still has not paid, the insurer can terminate the policy. The physician is left to collect from the patient whatever is owed for all outstanding claims.
The insurance company officials who testified at the hearing said that they had systems in place that gave physicians the ability to determine if a patient was current on payments and thus eligible for coverage. They did not give much detail beyond that.
Paul Wingle, executive director of individual business and public exchange operations and strategy at Aetna, said that doctors can call Aetna for updates on a patient’s payment status.
Brian Evanko, president of the individual segment at Cigna, said that physicians and hospitals can call or check online for a patient’s current insurance eligibility. J. Darren Rodgers, a senior vice president and marketing officer at Health Care Service Corporation, and Dennis Matheis, president of exchange strategy for Wellpoint, also said that their companies offered similar services for physicians to verify eligibility.
Rep. Burgess said that he still had concerns that physicians could end up delivering uncompensated care.
The insurers also said that, so far, it appears that a majority of exchange plan enrollees are paying their premiums.
Aetna enrolled 600,000 individuals by the third week in April. Of those, 500,000 have paid, said Mr. Wingle, noting that, since many enrollees have not reached the payment due date for coverage, the figure is "dynamic."
Cigna’s Mr. Evanko did not give enrollment or payment data.
Health Care Service Corporation had 830,000 applications for coverage – 600,000 on the exchanges and 230,000 from outside the exchanges, said Mr. Rodgers. In January, February, and March, 85%-88% of exchange plan enrollees had paid.
The payment rate dropped to 83% on April 1; May figures were incomplete, he said.
Mr. Matheis of Wellpoint testified that "we are seeing strong membership growth and large percentages of our newly enrolled customers are successfully paying their premiums by the due date."
He said that, overall, 70% of premiums have been paid, but that figure includes enrollees whose payments were not yet due. For those whose premium deadline has passed, the payment rate is up to 90%, said Mr. Matheis.
Rep. Tim Murphy (R-Pa.), chairman of the oversight and investigations subcommittee, said that the data submitted to the panel by insurers in late April "paints an uneven picture about the status of enrollment and payment through April 15."
A report issued by the Energy and Commerce Committee on April 30 claimed that data from insurers showed that 67% of the enrollees in the federal exchanges had paid their first month’s premium. Rep. Murphy said that the report showed a wild variation in payment rates by state, and that more information was needed.
"We recognize that many individuals still have time to pay their first month’s premium, which is why we have asked the insurers to update this information on May 20," he said.
On Twitter @aliciaault
Representatives of major insurance companies assured lawmakers that they have systems in place by which physicians can check whether patients newly insured through the state and federal health exchanges were up to date on payments for their premiums and thus eligible for coverage.
The insurers – Aetna, Cigna, Health Care Service Corporation, and Wellpoint – appeared May 7 before the House Energy and Commerce Oversight and Investigations Subcommittee to answer questions about how many enrollees under the Affordable Care Act’s state and federal health insurance exchanges have paid their premiums.
Rep. Michael Burgess (R-Tex.), a physician and a subcommittee member, said that he was especially concerned about the 90-day grace period that could create a situation in which care delivered by doctors is not covered by insurance companies.
The grace period was built into the Affordable Care Act.
According to the law, patients must pay their first month’s premium to be considered enrolled and verified as insured. After that, however, they have 90 days to pay the next premium. If the patient doesn’t pay for the second month, the insurer can hold or "pend" all claims. By the third month, if the patient still has not paid, the insurer can terminate the policy. The physician is left to collect from the patient whatever is owed for all outstanding claims.
The insurance company officials who testified at the hearing said that they had systems in place that gave physicians the ability to determine if a patient was current on payments and thus eligible for coverage. They did not give much detail beyond that.
Paul Wingle, executive director of individual business and public exchange operations and strategy at Aetna, said that doctors can call Aetna for updates on a patient’s payment status.
Brian Evanko, president of the individual segment at Cigna, said that physicians and hospitals can call or check online for a patient’s current insurance eligibility. J. Darren Rodgers, a senior vice president and marketing officer at Health Care Service Corporation, and Dennis Matheis, president of exchange strategy for Wellpoint, also said that their companies offered similar services for physicians to verify eligibility.
Rep. Burgess said that he still had concerns that physicians could end up delivering uncompensated care.
The insurers also said that, so far, it appears that a majority of exchange plan enrollees are paying their premiums.
Aetna enrolled 600,000 individuals by the third week in April. Of those, 500,000 have paid, said Mr. Wingle, noting that, since many enrollees have not reached the payment due date for coverage, the figure is "dynamic."
Cigna’s Mr. Evanko did not give enrollment or payment data.
Health Care Service Corporation had 830,000 applications for coverage – 600,000 on the exchanges and 230,000 from outside the exchanges, said Mr. Rodgers. In January, February, and March, 85%-88% of exchange plan enrollees had paid.
The payment rate dropped to 83% on April 1; May figures were incomplete, he said.
Mr. Matheis of Wellpoint testified that "we are seeing strong membership growth and large percentages of our newly enrolled customers are successfully paying their premiums by the due date."
He said that, overall, 70% of premiums have been paid, but that figure includes enrollees whose payments were not yet due. For those whose premium deadline has passed, the payment rate is up to 90%, said Mr. Matheis.
Rep. Tim Murphy (R-Pa.), chairman of the oversight and investigations subcommittee, said that the data submitted to the panel by insurers in late April "paints an uneven picture about the status of enrollment and payment through April 15."
A report issued by the Energy and Commerce Committee on April 30 claimed that data from insurers showed that 67% of the enrollees in the federal exchanges had paid their first month’s premium. Rep. Murphy said that the report showed a wild variation in payment rates by state, and that more information was needed.
"We recognize that many individuals still have time to pay their first month’s premium, which is why we have asked the insurers to update this information on May 20," he said.
On Twitter @aliciaault
Representatives of major insurance companies assured lawmakers that they have systems in place by which physicians can check whether patients newly insured through the state and federal health exchanges were up to date on payments for their premiums and thus eligible for coverage.
The insurers – Aetna, Cigna, Health Care Service Corporation, and Wellpoint – appeared May 7 before the House Energy and Commerce Oversight and Investigations Subcommittee to answer questions about how many enrollees under the Affordable Care Act’s state and federal health insurance exchanges have paid their premiums.
Rep. Michael Burgess (R-Tex.), a physician and a subcommittee member, said that he was especially concerned about the 90-day grace period that could create a situation in which care delivered by doctors is not covered by insurance companies.
The grace period was built into the Affordable Care Act.
According to the law, patients must pay their first month’s premium to be considered enrolled and verified as insured. After that, however, they have 90 days to pay the next premium. If the patient doesn’t pay for the second month, the insurer can hold or "pend" all claims. By the third month, if the patient still has not paid, the insurer can terminate the policy. The physician is left to collect from the patient whatever is owed for all outstanding claims.
The insurance company officials who testified at the hearing said that they had systems in place that gave physicians the ability to determine if a patient was current on payments and thus eligible for coverage. They did not give much detail beyond that.
Paul Wingle, executive director of individual business and public exchange operations and strategy at Aetna, said that doctors can call Aetna for updates on a patient’s payment status.
Brian Evanko, president of the individual segment at Cigna, said that physicians and hospitals can call or check online for a patient’s current insurance eligibility. J. Darren Rodgers, a senior vice president and marketing officer at Health Care Service Corporation, and Dennis Matheis, president of exchange strategy for Wellpoint, also said that their companies offered similar services for physicians to verify eligibility.
Rep. Burgess said that he still had concerns that physicians could end up delivering uncompensated care.
The insurers also said that, so far, it appears that a majority of exchange plan enrollees are paying their premiums.
Aetna enrolled 600,000 individuals by the third week in April. Of those, 500,000 have paid, said Mr. Wingle, noting that, since many enrollees have not reached the payment due date for coverage, the figure is "dynamic."
Cigna’s Mr. Evanko did not give enrollment or payment data.
Health Care Service Corporation had 830,000 applications for coverage – 600,000 on the exchanges and 230,000 from outside the exchanges, said Mr. Rodgers. In January, February, and March, 85%-88% of exchange plan enrollees had paid.
The payment rate dropped to 83% on April 1; May figures were incomplete, he said.
Mr. Matheis of Wellpoint testified that "we are seeing strong membership growth and large percentages of our newly enrolled customers are successfully paying their premiums by the due date."
He said that, overall, 70% of premiums have been paid, but that figure includes enrollees whose payments were not yet due. For those whose premium deadline has passed, the payment rate is up to 90%, said Mr. Matheis.
Rep. Tim Murphy (R-Pa.), chairman of the oversight and investigations subcommittee, said that the data submitted to the panel by insurers in late April "paints an uneven picture about the status of enrollment and payment through April 15."
A report issued by the Energy and Commerce Committee on April 30 claimed that data from insurers showed that 67% of the enrollees in the federal exchanges had paid their first month’s premium. Rep. Murphy said that the report showed a wild variation in payment rates by state, and that more information was needed.
"We recognize that many individuals still have time to pay their first month’s premium, which is why we have asked the insurers to update this information on May 20," he said.
On Twitter @aliciaault
Analysis finds the ED a profit center; ACA may drive higher profits
The emergency department is a profit center for many hospitals – and could help drive profits even higher as the Affordable Care Act extends insurance coverage to more Americans.
Dr. Michael Wilson, an emergency physician at Brigham and Women’s Hospital, Boston, and David M. Cutler, Ph.D., an economics professor at Harvard University, Cambridge, Mass., looked at more than 11 million emergency department (ED) visits for which patient-level revenue information was available as well as 20 million observations with charge data.
Of those visits, 35% were covered by private insurance, 26% by Medicaid, 21% by Medicare, and 18% were uninsured.
They found that in 2009, hospitals generated ED revenues of about $79 billion, at a cost of $73 billion. The $6.1 billion profit translated into an almost 8% profit margin. The profits came primarily from private pay patients. Hospitals made a 40% margin on the privately insured, or about $17 billion, according to the analysis. This compensated for losses on Medicare (–6%), Medicaid (–40%), and the uninsured (–60%) (Health Affairs 2014;5792-9 [doi 10.1377/hlthaff.2013.0754]).
"One of the more surprising findings was just how dependent the emergency department is on payer mix," Dr. Wilson said, adding that EDs that do not have a large number of private pay patients may not be as profitable.
Dr. Wes Fields, *former chairman of the American College of Emergency Physicians’ Emergency Medicine Action Fund, agreed that payer mix is a key.
"For patients or policy makers trying to interpret the meaning of this study for their own community, it is important to remember that hospital profitability is like real estate valuation: ‘location, location, location,’ " Dr. Fields said.
A spokeswoman with the American Hospital Association said that it’s not just about payer mix. "It is hard to really measure the costs of ED care," said Marie Watteau, of the AHA. "Hospitals have to maintain the standby capacity of an ED 24/7 and that means having trauma teams at the ready. The costs to maintain that service is spread over all of the services provided by the hospital," she said.
Under the ACA, the number of paying patients should improve, Dr. Wilson said. He predicted that by 2023, profit margins would increase to 12%, using a scenario in which 50% of the uninsured remain uninsured, 25% gain private insurance, and 25% enroll in Medicaid. This also assumes that reimbursement for private insurance is at a rate that’s at the midpoint between employer-sponsored private insurance and Medicaid pay. Without the ACA, profit margins would continue to hover around 7%, they said.
Dr. Fields said he was a little skeptical that more Medicaid coverage would increase revenues or profits. Some studies have shown that people who gain Medicaid coverage often are high utilizers of EDs, he said. More use means adding more staff, which is one of the biggest costs for hospitals.
On Twitter @aliciaault
*Correction 5/8/14: A previous version of this story misidentified Dr. Wes Fields as the chairman of the American College of Emergency Physicians’ Emergency Medicine Action Fund. This version has been corrected and updated.
The emergency department is a profit center for many hospitals – and could help drive profits even higher as the Affordable Care Act extends insurance coverage to more Americans.
Dr. Michael Wilson, an emergency physician at Brigham and Women’s Hospital, Boston, and David M. Cutler, Ph.D., an economics professor at Harvard University, Cambridge, Mass., looked at more than 11 million emergency department (ED) visits for which patient-level revenue information was available as well as 20 million observations with charge data.
Of those visits, 35% were covered by private insurance, 26% by Medicaid, 21% by Medicare, and 18% were uninsured.
They found that in 2009, hospitals generated ED revenues of about $79 billion, at a cost of $73 billion. The $6.1 billion profit translated into an almost 8% profit margin. The profits came primarily from private pay patients. Hospitals made a 40% margin on the privately insured, or about $17 billion, according to the analysis. This compensated for losses on Medicare (–6%), Medicaid (–40%), and the uninsured (–60%) (Health Affairs 2014;5792-9 [doi 10.1377/hlthaff.2013.0754]).
"One of the more surprising findings was just how dependent the emergency department is on payer mix," Dr. Wilson said, adding that EDs that do not have a large number of private pay patients may not be as profitable.
Dr. Wes Fields, *former chairman of the American College of Emergency Physicians’ Emergency Medicine Action Fund, agreed that payer mix is a key.
"For patients or policy makers trying to interpret the meaning of this study for their own community, it is important to remember that hospital profitability is like real estate valuation: ‘location, location, location,’ " Dr. Fields said.
A spokeswoman with the American Hospital Association said that it’s not just about payer mix. "It is hard to really measure the costs of ED care," said Marie Watteau, of the AHA. "Hospitals have to maintain the standby capacity of an ED 24/7 and that means having trauma teams at the ready. The costs to maintain that service is spread over all of the services provided by the hospital," she said.
Under the ACA, the number of paying patients should improve, Dr. Wilson said. He predicted that by 2023, profit margins would increase to 12%, using a scenario in which 50% of the uninsured remain uninsured, 25% gain private insurance, and 25% enroll in Medicaid. This also assumes that reimbursement for private insurance is at a rate that’s at the midpoint between employer-sponsored private insurance and Medicaid pay. Without the ACA, profit margins would continue to hover around 7%, they said.
Dr. Fields said he was a little skeptical that more Medicaid coverage would increase revenues or profits. Some studies have shown that people who gain Medicaid coverage often are high utilizers of EDs, he said. More use means adding more staff, which is one of the biggest costs for hospitals.
On Twitter @aliciaault
*Correction 5/8/14: A previous version of this story misidentified Dr. Wes Fields as the chairman of the American College of Emergency Physicians’ Emergency Medicine Action Fund. This version has been corrected and updated.
The emergency department is a profit center for many hospitals – and could help drive profits even higher as the Affordable Care Act extends insurance coverage to more Americans.
Dr. Michael Wilson, an emergency physician at Brigham and Women’s Hospital, Boston, and David M. Cutler, Ph.D., an economics professor at Harvard University, Cambridge, Mass., looked at more than 11 million emergency department (ED) visits for which patient-level revenue information was available as well as 20 million observations with charge data.
Of those visits, 35% were covered by private insurance, 26% by Medicaid, 21% by Medicare, and 18% were uninsured.
They found that in 2009, hospitals generated ED revenues of about $79 billion, at a cost of $73 billion. The $6.1 billion profit translated into an almost 8% profit margin. The profits came primarily from private pay patients. Hospitals made a 40% margin on the privately insured, or about $17 billion, according to the analysis. This compensated for losses on Medicare (–6%), Medicaid (–40%), and the uninsured (–60%) (Health Affairs 2014;5792-9 [doi 10.1377/hlthaff.2013.0754]).
"One of the more surprising findings was just how dependent the emergency department is on payer mix," Dr. Wilson said, adding that EDs that do not have a large number of private pay patients may not be as profitable.
Dr. Wes Fields, *former chairman of the American College of Emergency Physicians’ Emergency Medicine Action Fund, agreed that payer mix is a key.
"For patients or policy makers trying to interpret the meaning of this study for their own community, it is important to remember that hospital profitability is like real estate valuation: ‘location, location, location,’ " Dr. Fields said.
A spokeswoman with the American Hospital Association said that it’s not just about payer mix. "It is hard to really measure the costs of ED care," said Marie Watteau, of the AHA. "Hospitals have to maintain the standby capacity of an ED 24/7 and that means having trauma teams at the ready. The costs to maintain that service is spread over all of the services provided by the hospital," she said.
Under the ACA, the number of paying patients should improve, Dr. Wilson said. He predicted that by 2023, profit margins would increase to 12%, using a scenario in which 50% of the uninsured remain uninsured, 25% gain private insurance, and 25% enroll in Medicaid. This also assumes that reimbursement for private insurance is at a rate that’s at the midpoint between employer-sponsored private insurance and Medicaid pay. Without the ACA, profit margins would continue to hover around 7%, they said.
Dr. Fields said he was a little skeptical that more Medicaid coverage would increase revenues or profits. Some studies have shown that people who gain Medicaid coverage often are high utilizers of EDs, he said. More use means adding more staff, which is one of the biggest costs for hospitals.
On Twitter @aliciaault
*Correction 5/8/14: A previous version of this story misidentified Dr. Wes Fields as the chairman of the American College of Emergency Physicians’ Emergency Medicine Action Fund. This version has been corrected and updated.
FROM THE JOURNAL HEALTH AFFAIRS
Major finding: Hospital EDs had an 8% profit margin in 2009, which may rise to 12% with additional insurance coverage provided through the Affordable Care Act.
Data source: An analysis of Medicare, Medicaid and private insurance cost, charge, and reimbursement data for 11 million ED visits.
Disclosures: Funding provided by the National Institute on Aging. The authors reported no conflicts.
Backlash grows against MOC process
Resistance against the American Board of Internal Medicine’s maintenance of certification process is growing, with an online petition to overturn the board’s most recent changes having collected more than 13,000 signatures at press time.
The petition was organized by Dr. Paul Teirstein, chief of cardiology and director of interventional cardiology for Scripps Clinic in La Jolla, Calif.
Dr. Teirstein said that he began the drive out of his own sense of frustration with the ABIM maintenance of certification (MOC) requirements. He e-mailed some physicians he knew and encouraged them to sign. The petition went viral soon after being posted on March 20, Dr. Teirstein said.
Those who sign the petition agree that:
• ABIM has made unreasonable changes in MOC requiring more frequent participation and higher fees.
• Scientific data demonstrating the benefit of MOC is lacking.
• MOC activities are complex, of questionable value, and detract from other worthwhile pursuits, including patient care and other educational activities.
• A test administered every 10 years for recertification is a sufficient metric for MOC.
The bottom line: Petition signers want the ABIM to overhaul the process and require recertification once every 10 years.
The ABIM took the effort seriously enough to respond on its Web site.
"As medical knowledge and practices continue to change, a continuous MOC program tells the community that a physician is staying up-to-date, has met a knowledge standard established by his or her physician peers, and is engaged in ongoing assessment of his or her practice," Dr. Richard Baron, ABIM president, said in the statement.
Physicians who commented on the petition did not agree.
Dr. Jesse Naghi, a third-year fellow at the University of California, San Diego, Sulpizio Cardiovascular Center, wrote, "Asking for more money on top of our already high recertification fees seems rather greedy."
"This is an arm-twisting and money-making scam by our own board," said Dr. Garrett Sanford, of Little Rock, Ark.
"We do recognize that there is a cost – for the large majority of our physicians, the entire program costs from $200 to $400 per year," said Dr. Baron, in his statement. "Our fee structure covers the costs of developing and administering the secure, computer-based exams at test centers nationwide, as well as the ongoing development and release of all ABIM self-assessment products," he said, adding, "I encourage the petition signers to visit ABIM’s revenue and expenses [Web page] for more information."
Some family physicians also have taken issue with MOC. One such, Dr. Edward Volpintesta of Bethel Conn., said in an interview that: "MOC, for both internists and family physicians has become an unnecessary and unreasonable source of strain and disillusionment for many primary care doctors.
"Once a physician has received initial certification there should be no reason to revoke it," he said.
The boards started out as a voluntary undertaking. Now, because they can be used for admittance to hospital medical staffs, a requirement for re-licensure, and by insurers as a physician qualifier, MOC has lost its voluntary status and is no de fecto mandatory.
"Clearly, our physician leadership organizations have not mustered the courage to defeat the MOC requirement. ... Perhaps the best way of solving this problem is to fight it out in court as the American Association of Physicians and Surgeons is doing," according to Dr. Volpintesta, who has been in practice for 40 years.
Petition signers also claim that contrary to the board’s contention, neither patients nor payers value the MOC process nor are they demanding that physicians prove they’ve met the requirements. They also say that there is no evidence that MOC improves quality of care.
The board does not agree. "There is a good deal of research demonstrating the value of MOC. From the validity of the examination, to the importance of independent assessments – clinicians are not good at evaluating their own weaknesses," according to Dr. Baron’s statement.
Dr. Baron also promised that the ABIM would create more ways for physicians to earn credit.
The ABIM’s open letter shows that "the petition has definitely had an impact," Dr. Teirstein said.
Dr. Ron Benbassat, a cofounder of Change Board Certification, a group that wants to scale back the MOC, called Dr. Baron’s remarks a "boilerplate political statement."
The MOC "should be eliminated, given the numerous CME programs that exist that are not only cost effective, but are incredibly successful, and do not take time away from patient care," said Dr. Benbassat, a board-certified internist in Beverly Hills, Calif., who has completed MOC once already.
Dr. Benbassat and the physicians who have joined Change Board Certification, believe that MOC should not be associated with hospital privileges, insurance reimbursement, or network participation. It should not be required for maintenance of licensure either, said Dr. Benbassat, who is concerned that ABIM is discussing tying licensure to MOC.
Meanwhile, the Association of American Physicians and Surgeons has filed suit against the American Board of Medical Specialties, claiming that the MOC process is a restraint of trade because it will effectively keep doctors from practicing if they do not participate. The suit was filed in the U.S. District Court for the District of New Jersey on April 23, and seeks to stop what it calls the ABMS’s "continuing violations of antitrust law and misrepresentations about the medical skills of physicians who decline to purchase and spend time on its program."
The organization is also aiming to get a refund of fees paid by its members to ABMS and its 24 member boards.
On Twitter @aliciaault
Resistance against the American Board of Internal Medicine’s maintenance of certification process is growing, with an online petition to overturn the board’s most recent changes having collected more than 13,000 signatures at press time.
The petition was organized by Dr. Paul Teirstein, chief of cardiology and director of interventional cardiology for Scripps Clinic in La Jolla, Calif.
Dr. Teirstein said that he began the drive out of his own sense of frustration with the ABIM maintenance of certification (MOC) requirements. He e-mailed some physicians he knew and encouraged them to sign. The petition went viral soon after being posted on March 20, Dr. Teirstein said.
Those who sign the petition agree that:
• ABIM has made unreasonable changes in MOC requiring more frequent participation and higher fees.
• Scientific data demonstrating the benefit of MOC is lacking.
• MOC activities are complex, of questionable value, and detract from other worthwhile pursuits, including patient care and other educational activities.
• A test administered every 10 years for recertification is a sufficient metric for MOC.
The bottom line: Petition signers want the ABIM to overhaul the process and require recertification once every 10 years.
The ABIM took the effort seriously enough to respond on its Web site.
"As medical knowledge and practices continue to change, a continuous MOC program tells the community that a physician is staying up-to-date, has met a knowledge standard established by his or her physician peers, and is engaged in ongoing assessment of his or her practice," Dr. Richard Baron, ABIM president, said in the statement.
Physicians who commented on the petition did not agree.
Dr. Jesse Naghi, a third-year fellow at the University of California, San Diego, Sulpizio Cardiovascular Center, wrote, "Asking for more money on top of our already high recertification fees seems rather greedy."
"This is an arm-twisting and money-making scam by our own board," said Dr. Garrett Sanford, of Little Rock, Ark.
"We do recognize that there is a cost – for the large majority of our physicians, the entire program costs from $200 to $400 per year," said Dr. Baron, in his statement. "Our fee structure covers the costs of developing and administering the secure, computer-based exams at test centers nationwide, as well as the ongoing development and release of all ABIM self-assessment products," he said, adding, "I encourage the petition signers to visit ABIM’s revenue and expenses [Web page] for more information."
Some family physicians also have taken issue with MOC. One such, Dr. Edward Volpintesta of Bethel Conn., said in an interview that: "MOC, for both internists and family physicians has become an unnecessary and unreasonable source of strain and disillusionment for many primary care doctors.
"Once a physician has received initial certification there should be no reason to revoke it," he said.
The boards started out as a voluntary undertaking. Now, because they can be used for admittance to hospital medical staffs, a requirement for re-licensure, and by insurers as a physician qualifier, MOC has lost its voluntary status and is no de fecto mandatory.
"Clearly, our physician leadership organizations have not mustered the courage to defeat the MOC requirement. ... Perhaps the best way of solving this problem is to fight it out in court as the American Association of Physicians and Surgeons is doing," according to Dr. Volpintesta, who has been in practice for 40 years.
Petition signers also claim that contrary to the board’s contention, neither patients nor payers value the MOC process nor are they demanding that physicians prove they’ve met the requirements. They also say that there is no evidence that MOC improves quality of care.
The board does not agree. "There is a good deal of research demonstrating the value of MOC. From the validity of the examination, to the importance of independent assessments – clinicians are not good at evaluating their own weaknesses," according to Dr. Baron’s statement.
Dr. Baron also promised that the ABIM would create more ways for physicians to earn credit.
The ABIM’s open letter shows that "the petition has definitely had an impact," Dr. Teirstein said.
Dr. Ron Benbassat, a cofounder of Change Board Certification, a group that wants to scale back the MOC, called Dr. Baron’s remarks a "boilerplate political statement."
The MOC "should be eliminated, given the numerous CME programs that exist that are not only cost effective, but are incredibly successful, and do not take time away from patient care," said Dr. Benbassat, a board-certified internist in Beverly Hills, Calif., who has completed MOC once already.
Dr. Benbassat and the physicians who have joined Change Board Certification, believe that MOC should not be associated with hospital privileges, insurance reimbursement, or network participation. It should not be required for maintenance of licensure either, said Dr. Benbassat, who is concerned that ABIM is discussing tying licensure to MOC.
Meanwhile, the Association of American Physicians and Surgeons has filed suit against the American Board of Medical Specialties, claiming that the MOC process is a restraint of trade because it will effectively keep doctors from practicing if they do not participate. The suit was filed in the U.S. District Court for the District of New Jersey on April 23, and seeks to stop what it calls the ABMS’s "continuing violations of antitrust law and misrepresentations about the medical skills of physicians who decline to purchase and spend time on its program."
The organization is also aiming to get a refund of fees paid by its members to ABMS and its 24 member boards.
On Twitter @aliciaault
Resistance against the American Board of Internal Medicine’s maintenance of certification process is growing, with an online petition to overturn the board’s most recent changes having collected more than 13,000 signatures at press time.
The petition was organized by Dr. Paul Teirstein, chief of cardiology and director of interventional cardiology for Scripps Clinic in La Jolla, Calif.
Dr. Teirstein said that he began the drive out of his own sense of frustration with the ABIM maintenance of certification (MOC) requirements. He e-mailed some physicians he knew and encouraged them to sign. The petition went viral soon after being posted on March 20, Dr. Teirstein said.
Those who sign the petition agree that:
• ABIM has made unreasonable changes in MOC requiring more frequent participation and higher fees.
• Scientific data demonstrating the benefit of MOC is lacking.
• MOC activities are complex, of questionable value, and detract from other worthwhile pursuits, including patient care and other educational activities.
• A test administered every 10 years for recertification is a sufficient metric for MOC.
The bottom line: Petition signers want the ABIM to overhaul the process and require recertification once every 10 years.
The ABIM took the effort seriously enough to respond on its Web site.
"As medical knowledge and practices continue to change, a continuous MOC program tells the community that a physician is staying up-to-date, has met a knowledge standard established by his or her physician peers, and is engaged in ongoing assessment of his or her practice," Dr. Richard Baron, ABIM president, said in the statement.
Physicians who commented on the petition did not agree.
Dr. Jesse Naghi, a third-year fellow at the University of California, San Diego, Sulpizio Cardiovascular Center, wrote, "Asking for more money on top of our already high recertification fees seems rather greedy."
"This is an arm-twisting and money-making scam by our own board," said Dr. Garrett Sanford, of Little Rock, Ark.
"We do recognize that there is a cost – for the large majority of our physicians, the entire program costs from $200 to $400 per year," said Dr. Baron, in his statement. "Our fee structure covers the costs of developing and administering the secure, computer-based exams at test centers nationwide, as well as the ongoing development and release of all ABIM self-assessment products," he said, adding, "I encourage the petition signers to visit ABIM’s revenue and expenses [Web page] for more information."
Some family physicians also have taken issue with MOC. One such, Dr. Edward Volpintesta of Bethel Conn., said in an interview that: "MOC, for both internists and family physicians has become an unnecessary and unreasonable source of strain and disillusionment for many primary care doctors.
"Once a physician has received initial certification there should be no reason to revoke it," he said.
The boards started out as a voluntary undertaking. Now, because they can be used for admittance to hospital medical staffs, a requirement for re-licensure, and by insurers as a physician qualifier, MOC has lost its voluntary status and is no de fecto mandatory.
"Clearly, our physician leadership organizations have not mustered the courage to defeat the MOC requirement. ... Perhaps the best way of solving this problem is to fight it out in court as the American Association of Physicians and Surgeons is doing," according to Dr. Volpintesta, who has been in practice for 40 years.
Petition signers also claim that contrary to the board’s contention, neither patients nor payers value the MOC process nor are they demanding that physicians prove they’ve met the requirements. They also say that there is no evidence that MOC improves quality of care.
The board does not agree. "There is a good deal of research demonstrating the value of MOC. From the validity of the examination, to the importance of independent assessments – clinicians are not good at evaluating their own weaknesses," according to Dr. Baron’s statement.
Dr. Baron also promised that the ABIM would create more ways for physicians to earn credit.
The ABIM’s open letter shows that "the petition has definitely had an impact," Dr. Teirstein said.
Dr. Ron Benbassat, a cofounder of Change Board Certification, a group that wants to scale back the MOC, called Dr. Baron’s remarks a "boilerplate political statement."
The MOC "should be eliminated, given the numerous CME programs that exist that are not only cost effective, but are incredibly successful, and do not take time away from patient care," said Dr. Benbassat, a board-certified internist in Beverly Hills, Calif., who has completed MOC once already.
Dr. Benbassat and the physicians who have joined Change Board Certification, believe that MOC should not be associated with hospital privileges, insurance reimbursement, or network participation. It should not be required for maintenance of licensure either, said Dr. Benbassat, who is concerned that ABIM is discussing tying licensure to MOC.
Meanwhile, the Association of American Physicians and Surgeons has filed suit against the American Board of Medical Specialties, claiming that the MOC process is a restraint of trade because it will effectively keep doctors from practicing if they do not participate. The suit was filed in the U.S. District Court for the District of New Jersey on April 23, and seeks to stop what it calls the ABMS’s "continuing violations of antitrust law and misrepresentations about the medical skills of physicians who decline to purchase and spend time on its program."
The organization is also aiming to get a refund of fees paid by its members to ABMS and its 24 member boards.
On Twitter @aliciaault
Backlash grows against MOC process
Resistance against the American Board of Internal Medicine’s maintenance of certification process is growing, with an online petition to overturn the board’s most recent changes having collected more than 13,000 signatures at press time.
The petition was organized by Dr. Paul Teirstein, chief of cardiology and director of interventional cardiology for Scripps Clinic in La Jolla, Calif.
Dr. Teirstein said that he began the drive out of his own sense of frustration with the ABIM maintenance of certification (MOC) requirements. He e-mailed some physicians he knew and encouraged them to sign. The petition went viral soon after being posted on March 20, Dr. Teirstein said.
Those who sign the petition agree that:
• ABIM has made unreasonable changes in MOC requiring more frequent participation and higher fees.
• Scientific data demonstrating the benefit of MOC is lacking.
• MOC activities are complex, of questionable value, and detract from other worthwhile pursuits, including patient care and other educational activities.
• A test administered every 10 years for recertification is a sufficient metric for MOC.
The bottom line: Petition signers want the ABIM to overhaul the process and require recertification once every 10 years.
The ABIM took the effort seriously enough to respond on its Web site.
"As medical knowledge and practices continue to change, a continuous MOC program tells the community that a physician is staying up-to-date, has met a knowledge standard established by his or her physician peers, and is engaged in ongoing assessment of his or her practice," Dr. Richard Baron, ABIM president, said in the statement.
Physicians who commented on the petition did not agree.
Dr. Jesse Naghi, a third-year fellow at the University of California, San Diego, Sulpizio Cardiovascular Center, wrote, "Asking for more money on top of our already high recertification fees seems rather greedy."
"This is an arm-twisting and money-making scam by our own board," said Dr. Garrett Sanford, of Little Rock, Ark.
"We do recognize that there is a cost – for the large majority of our physicians, the entire program costs from $200 to $400 per year," said Dr. Baron, in his statement. "Our fee structure covers the costs of developing and administering the secure, computer-based exams at test centers nationwide, as well as the ongoing development and release of all ABIM self-assessment products," he said, adding, "I encourage the petition signers to visit ABIM’s revenue and expenses [Web page] for more information."
Petition signers also claim that contrary to the board’s contention, neither patients nor payers value the MOC process nor are they demanding that physicians prove they’ve met the requirements. They also say that there is no evidence that MOC improves quality of care.
The board does not agree. "There is a good deal of research demonstrating the value of MOC. From the validity of the examination, to the importance of independent assessments – clinicians are not good at evaluating their own weaknesses," according to Dr. Baron’s statement.
Dr. Baron also promised that the ABIM would create more ways for physicians to earn credit.
The ABIM’s open letter shows that "the petition has definitely had an impact," Dr. Teirstein said.
Dr. Ron Benbassat, a cofounder of Change Board Certification, a group that wants to scale back the MOC, called Dr. Baron’s remarks a "boilerplate political statement."
The MOC "should be eliminated, given the numerous CME programs that exist that are not only cost effective, but are incredibly successful, and do not take time away from patient care," said Dr. Benbassat, a board-certified internist in Beverly Hills, Calif., who has completed MOC once already.
Dr. Benbassat and the physicians who have joined Change Board Certification, believe that MOC should not be associated with hospital privileges, insurance reimbursement, or network participation. It should not be required for maintenance of licensure either, said Dr. Benbassat, who is concerned that ABIM is discussing tying licensure to MOC.
Meanwhile, the Association of American Physicians and Surgeons has filed suit against the American Board of Medical Specialties, claiming that the MOC process is a restraint of trade because it will effectively keep doctors from practicing if they do not participate. The suit was filed in the U.S. District Court for the District of New Jersey on April 23, and seeks to stop what it calls the ABMS’s "continuing violations of antitrust law and misrepresentations about the medical skills of physicians who decline to purchase and spend time on its program."
The organization is also aiming to get a refund of fees paid by its members to ABMS and its 24 member boards.
On Twitter @aliciaault
Resistance against the American Board of Internal Medicine’s maintenance of certification process is growing, with an online petition to overturn the board’s most recent changes having collected more than 13,000 signatures at press time.
The petition was organized by Dr. Paul Teirstein, chief of cardiology and director of interventional cardiology for Scripps Clinic in La Jolla, Calif.
Dr. Teirstein said that he began the drive out of his own sense of frustration with the ABIM maintenance of certification (MOC) requirements. He e-mailed some physicians he knew and encouraged them to sign. The petition went viral soon after being posted on March 20, Dr. Teirstein said.
Those who sign the petition agree that:
• ABIM has made unreasonable changes in MOC requiring more frequent participation and higher fees.
• Scientific data demonstrating the benefit of MOC is lacking.
• MOC activities are complex, of questionable value, and detract from other worthwhile pursuits, including patient care and other educational activities.
• A test administered every 10 years for recertification is a sufficient metric for MOC.
The bottom line: Petition signers want the ABIM to overhaul the process and require recertification once every 10 years.
The ABIM took the effort seriously enough to respond on its Web site.
"As medical knowledge and practices continue to change, a continuous MOC program tells the community that a physician is staying up-to-date, has met a knowledge standard established by his or her physician peers, and is engaged in ongoing assessment of his or her practice," Dr. Richard Baron, ABIM president, said in the statement.
Physicians who commented on the petition did not agree.
Dr. Jesse Naghi, a third-year fellow at the University of California, San Diego, Sulpizio Cardiovascular Center, wrote, "Asking for more money on top of our already high recertification fees seems rather greedy."
"This is an arm-twisting and money-making scam by our own board," said Dr. Garrett Sanford, of Little Rock, Ark.
"We do recognize that there is a cost – for the large majority of our physicians, the entire program costs from $200 to $400 per year," said Dr. Baron, in his statement. "Our fee structure covers the costs of developing and administering the secure, computer-based exams at test centers nationwide, as well as the ongoing development and release of all ABIM self-assessment products," he said, adding, "I encourage the petition signers to visit ABIM’s revenue and expenses [Web page] for more information."
Petition signers also claim that contrary to the board’s contention, neither patients nor payers value the MOC process nor are they demanding that physicians prove they’ve met the requirements. They also say that there is no evidence that MOC improves quality of care.
The board does not agree. "There is a good deal of research demonstrating the value of MOC. From the validity of the examination, to the importance of independent assessments – clinicians are not good at evaluating their own weaknesses," according to Dr. Baron’s statement.
Dr. Baron also promised that the ABIM would create more ways for physicians to earn credit.
The ABIM’s open letter shows that "the petition has definitely had an impact," Dr. Teirstein said.
Dr. Ron Benbassat, a cofounder of Change Board Certification, a group that wants to scale back the MOC, called Dr. Baron’s remarks a "boilerplate political statement."
The MOC "should be eliminated, given the numerous CME programs that exist that are not only cost effective, but are incredibly successful, and do not take time away from patient care," said Dr. Benbassat, a board-certified internist in Beverly Hills, Calif., who has completed MOC once already.
Dr. Benbassat and the physicians who have joined Change Board Certification, believe that MOC should not be associated with hospital privileges, insurance reimbursement, or network participation. It should not be required for maintenance of licensure either, said Dr. Benbassat, who is concerned that ABIM is discussing tying licensure to MOC.
Meanwhile, the Association of American Physicians and Surgeons has filed suit against the American Board of Medical Specialties, claiming that the MOC process is a restraint of trade because it will effectively keep doctors from practicing if they do not participate. The suit was filed in the U.S. District Court for the District of New Jersey on April 23, and seeks to stop what it calls the ABMS’s "continuing violations of antitrust law and misrepresentations about the medical skills of physicians who decline to purchase and spend time on its program."
The organization is also aiming to get a refund of fees paid by its members to ABMS and its 24 member boards.
On Twitter @aliciaault
Resistance against the American Board of Internal Medicine’s maintenance of certification process is growing, with an online petition to overturn the board’s most recent changes having collected more than 13,000 signatures at press time.
The petition was organized by Dr. Paul Teirstein, chief of cardiology and director of interventional cardiology for Scripps Clinic in La Jolla, Calif.
Dr. Teirstein said that he began the drive out of his own sense of frustration with the ABIM maintenance of certification (MOC) requirements. He e-mailed some physicians he knew and encouraged them to sign. The petition went viral soon after being posted on March 20, Dr. Teirstein said.
Those who sign the petition agree that:
• ABIM has made unreasonable changes in MOC requiring more frequent participation and higher fees.
• Scientific data demonstrating the benefit of MOC is lacking.
• MOC activities are complex, of questionable value, and detract from other worthwhile pursuits, including patient care and other educational activities.
• A test administered every 10 years for recertification is a sufficient metric for MOC.
The bottom line: Petition signers want the ABIM to overhaul the process and require recertification once every 10 years.
The ABIM took the effort seriously enough to respond on its Web site.
"As medical knowledge and practices continue to change, a continuous MOC program tells the community that a physician is staying up-to-date, has met a knowledge standard established by his or her physician peers, and is engaged in ongoing assessment of his or her practice," Dr. Richard Baron, ABIM president, said in the statement.
Physicians who commented on the petition did not agree.
Dr. Jesse Naghi, a third-year fellow at the University of California, San Diego, Sulpizio Cardiovascular Center, wrote, "Asking for more money on top of our already high recertification fees seems rather greedy."
"This is an arm-twisting and money-making scam by our own board," said Dr. Garrett Sanford, of Little Rock, Ark.
"We do recognize that there is a cost – for the large majority of our physicians, the entire program costs from $200 to $400 per year," said Dr. Baron, in his statement. "Our fee structure covers the costs of developing and administering the secure, computer-based exams at test centers nationwide, as well as the ongoing development and release of all ABIM self-assessment products," he said, adding, "I encourage the petition signers to visit ABIM’s revenue and expenses [Web page] for more information."
Petition signers also claim that contrary to the board’s contention, neither patients nor payers value the MOC process nor are they demanding that physicians prove they’ve met the requirements. They also say that there is no evidence that MOC improves quality of care.
The board does not agree. "There is a good deal of research demonstrating the value of MOC. From the validity of the examination, to the importance of independent assessments – clinicians are not good at evaluating their own weaknesses," according to Dr. Baron’s statement.
Dr. Baron also promised that the ABIM would create more ways for physicians to earn credit.
The ABIM’s open letter shows that "the petition has definitely had an impact," Dr. Teirstein said.
Dr. Ron Benbassat, a cofounder of Change Board Certification, a group that wants to scale back the MOC, called Dr. Baron’s remarks a "boilerplate political statement."
The MOC "should be eliminated, given the numerous CME programs that exist that are not only cost effective, but are incredibly successful, and do not take time away from patient care," said Dr. Benbassat, a board-certified internist in Beverly Hills, Calif., who has completed MOC once already.
Dr. Benbassat and the physicians who have joined Change Board Certification, believe that MOC should not be associated with hospital privileges, insurance reimbursement, or network participation. It should not be required for maintenance of licensure either, said Dr. Benbassat, who is concerned that ABIM is discussing tying licensure to MOC.
Meanwhile, the Association of American Physicians and Surgeons has filed suit against the American Board of Medical Specialties, claiming that the MOC process is a restraint of trade because it will effectively keep doctors from practicing if they do not participate. The suit was filed in the U.S. District Court for the District of New Jersey on April 23, and seeks to stop what it calls the ABMS’s "continuing violations of antitrust law and misrepresentations about the medical skills of physicians who decline to purchase and spend time on its program."
The organization is also aiming to get a refund of fees paid by its members to ABMS and its 24 member boards.
On Twitter @aliciaault
