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CPAP adherence improves with partner support
MINNEAPOLIS – People with obstructive sleep apnea who have spouses or supportive partners tend to use their continuous positive airway pressure devices for longer periods of time.
That’s according to a study to be presented at the annual meeting of the Associated Professional Sleep Societies on June 2 by researchers at the University of Pittsburgh School of Nursing and at National Jewish Health in Denver.
The findings indicate that patients who live alone or do not have a supportive family might benefit from a group setting during the initial use of the CPAP. New, single users could also be paired off with peer "buddies" who can share experience and offer advice, according to principal investigator Faith Luyster, Ph.D.
Dr. Luyster performed a subanalysis of patients enrolled in a larger randomized, controlled trial conducted by Mark Aloia, Ph.D., associate professor of medicine at National Jewish Health, when he was a resident at Brown University in Providence, R.I. That larger study enrolled patients with obstructive sleep apnea (OSA) to determine whether motivational interviewing or intensive education might increase the use of continuous positive airway pressure (CPAP).
Data were analyzed from 253 patients (100 women and 153 men), just starting CPAP. At the start of the study, 185 were part of a couple and 68 were never married; divorced or separated; or widowed. The quality of the relationship was assessed at baseline using the 12-item General Functioning subscale of the McMaster Family Assessment Device.
Study participants used a four-point Likert scale – rating the 12 statements as "strongly agree", "agree," "disagree," and "strongly disagree" to answer statements that included: "In times of crisis we can turn to each other for support;" "We can express feelings to each other;" and "We confide in each other." A high score is associated with poor relationship quality.
CPAP use was recorded by the device itself.
At 3 months, single patients had average CPAP use of 3.3 hours plus or minus 2.5 hours per night, and coupled patients had 4.3 hours plus or minus 2.6 hours per night (P less than .01). Patients who had a higher relationship quality also had better adherence (P less than .05).
"Ideally, physicians want patients to wear [the CPAP mask] all night," said Dr. Luyster. There are "some data to suggest that wearing it 6 to 7 hours a night can improve cognitive functioning and daytime sleepiness."
Having a supportive partner or family member can help, especially in the beginning of CPAP use. The mask may need to be adjusted, and the user needs to get acclimated to sleeping with a mask. "It’s very helpful for patients to have cheerleaders," who can encourage and assist them, remind them to use the device, and help them to clean the CPAP device daily.
And it helps to have someone who’s accepting of the patient when wearing the CPAP mask. In focus groups, men were very concerned about how they would look to their partners, said Dr. Luyster. Women were more concerned that everyone was sleeping well again.
The authors reported no financial conflicts. The study was funded by the National Heart, Lung and Blood Institute.
[email protected]
On Twitter @aliciaault
MINNEAPOLIS – People with obstructive sleep apnea who have spouses or supportive partners tend to use their continuous positive airway pressure devices for longer periods of time.
That’s according to a study to be presented at the annual meeting of the Associated Professional Sleep Societies on June 2 by researchers at the University of Pittsburgh School of Nursing and at National Jewish Health in Denver.
The findings indicate that patients who live alone or do not have a supportive family might benefit from a group setting during the initial use of the CPAP. New, single users could also be paired off with peer "buddies" who can share experience and offer advice, according to principal investigator Faith Luyster, Ph.D.
Dr. Luyster performed a subanalysis of patients enrolled in a larger randomized, controlled trial conducted by Mark Aloia, Ph.D., associate professor of medicine at National Jewish Health, when he was a resident at Brown University in Providence, R.I. That larger study enrolled patients with obstructive sleep apnea (OSA) to determine whether motivational interviewing or intensive education might increase the use of continuous positive airway pressure (CPAP).
Data were analyzed from 253 patients (100 women and 153 men), just starting CPAP. At the start of the study, 185 were part of a couple and 68 were never married; divorced or separated; or widowed. The quality of the relationship was assessed at baseline using the 12-item General Functioning subscale of the McMaster Family Assessment Device.
Study participants used a four-point Likert scale – rating the 12 statements as "strongly agree", "agree," "disagree," and "strongly disagree" to answer statements that included: "In times of crisis we can turn to each other for support;" "We can express feelings to each other;" and "We confide in each other." A high score is associated with poor relationship quality.
CPAP use was recorded by the device itself.
At 3 months, single patients had average CPAP use of 3.3 hours plus or minus 2.5 hours per night, and coupled patients had 4.3 hours plus or minus 2.6 hours per night (P less than .01). Patients who had a higher relationship quality also had better adherence (P less than .05).
"Ideally, physicians want patients to wear [the CPAP mask] all night," said Dr. Luyster. There are "some data to suggest that wearing it 6 to 7 hours a night can improve cognitive functioning and daytime sleepiness."
Having a supportive partner or family member can help, especially in the beginning of CPAP use. The mask may need to be adjusted, and the user needs to get acclimated to sleeping with a mask. "It’s very helpful for patients to have cheerleaders," who can encourage and assist them, remind them to use the device, and help them to clean the CPAP device daily.
And it helps to have someone who’s accepting of the patient when wearing the CPAP mask. In focus groups, men were very concerned about how they would look to their partners, said Dr. Luyster. Women were more concerned that everyone was sleeping well again.
The authors reported no financial conflicts. The study was funded by the National Heart, Lung and Blood Institute.
[email protected]
On Twitter @aliciaault
MINNEAPOLIS – People with obstructive sleep apnea who have spouses or supportive partners tend to use their continuous positive airway pressure devices for longer periods of time.
That’s according to a study to be presented at the annual meeting of the Associated Professional Sleep Societies on June 2 by researchers at the University of Pittsburgh School of Nursing and at National Jewish Health in Denver.
The findings indicate that patients who live alone or do not have a supportive family might benefit from a group setting during the initial use of the CPAP. New, single users could also be paired off with peer "buddies" who can share experience and offer advice, according to principal investigator Faith Luyster, Ph.D.
Dr. Luyster performed a subanalysis of patients enrolled in a larger randomized, controlled trial conducted by Mark Aloia, Ph.D., associate professor of medicine at National Jewish Health, when he was a resident at Brown University in Providence, R.I. That larger study enrolled patients with obstructive sleep apnea (OSA) to determine whether motivational interviewing or intensive education might increase the use of continuous positive airway pressure (CPAP).
Data were analyzed from 253 patients (100 women and 153 men), just starting CPAP. At the start of the study, 185 were part of a couple and 68 were never married; divorced or separated; or widowed. The quality of the relationship was assessed at baseline using the 12-item General Functioning subscale of the McMaster Family Assessment Device.
Study participants used a four-point Likert scale – rating the 12 statements as "strongly agree", "agree," "disagree," and "strongly disagree" to answer statements that included: "In times of crisis we can turn to each other for support;" "We can express feelings to each other;" and "We confide in each other." A high score is associated with poor relationship quality.
CPAP use was recorded by the device itself.
At 3 months, single patients had average CPAP use of 3.3 hours plus or minus 2.5 hours per night, and coupled patients had 4.3 hours plus or minus 2.6 hours per night (P less than .01). Patients who had a higher relationship quality also had better adherence (P less than .05).
"Ideally, physicians want patients to wear [the CPAP mask] all night," said Dr. Luyster. There are "some data to suggest that wearing it 6 to 7 hours a night can improve cognitive functioning and daytime sleepiness."
Having a supportive partner or family member can help, especially in the beginning of CPAP use. The mask may need to be adjusted, and the user needs to get acclimated to sleeping with a mask. "It’s very helpful for patients to have cheerleaders," who can encourage and assist them, remind them to use the device, and help them to clean the CPAP device daily.
And it helps to have someone who’s accepting of the patient when wearing the CPAP mask. In focus groups, men were very concerned about how they would look to their partners, said Dr. Luyster. Women were more concerned that everyone was sleeping well again.
The authors reported no financial conflicts. The study was funded by the National Heart, Lung and Blood Institute.
[email protected]
On Twitter @aliciaault
FROM SLEEP 2014
Key clinical point: Coupled patients have better CPAP adherence.
Major finding: CPAP use was about an hour longer in coupled patients than in single patients, and adherence was related to relationship quality.
Data source: An analysis of 253 patients from a randomized, controlled trial.
Disclosures: The authors reported no financial conflicts. The study was funded by the National Heart, Lung and Blood Institute.
FDA approves blood test for membranous glomerulonephritis
The Food and Drug Administration has approved a noninvasive test to determine whether a chronic kidney disease is caused by an autoimmune disease or another cause such as infection.
The EUROIMMUN Anti- PLA2R IFA blood test detects an antibody that is specific to primary membranous glomerulonephritis (pMGN). MGN, a chronic kidney disease, damages the glomeruli; it can lead to kidney failure and transplant. Symptoms include swelling, hypercholesterolemia, hypertension, and an increased predisposition to blood clots.
The condition mostly affects white men. It occurs in 2 of every 10,000 people and is more common after age 40, according to the National Library of Medicine. Risk factors include cancers, especially lung and colon cancer; exposure to toxins, including gold and mercury; infections, including hepatitis B, malaria, syphilis, and endocarditis; certain medications, including penicillamine, trimethadione, and skin-lightening creams; and systemic lupus erythematosus, rheumatoid arthritis, Graves’ disease, and other autoimmune disorders.
"Treatment of MGN depends on the underlying cause of the disease," said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health, in a statement. "This test can help patients get a timely diagnosis for their MGN and aid with earlier treatment."
Test manufacturer EUROIMMUN US submitted data that compared 275 blood samples from patients with presumed pMGN, with 285 samples from patients diagnosed with other kidney diseases including secondary MGN (sMGN) and autoimmune diseases. The test detected pMGN in 77% of the presumed pMGN samples, and gave a false-positive result in less than 1% of the other samples.
The diagnostic test helped distinguish pMGN from sMGN in most of the patients.
The FDA said that the test should not be used alone to diagnose pMGN, but that patients’ symptoms and other laboratory test results should also be considered. A kidney biopsy is required for confirmation, according to the FDA.
On Twitter @aliciaault
The Food and Drug Administration has approved a noninvasive test to determine whether a chronic kidney disease is caused by an autoimmune disease or another cause such as infection.
The EUROIMMUN Anti- PLA2R IFA blood test detects an antibody that is specific to primary membranous glomerulonephritis (pMGN). MGN, a chronic kidney disease, damages the glomeruli; it can lead to kidney failure and transplant. Symptoms include swelling, hypercholesterolemia, hypertension, and an increased predisposition to blood clots.
The condition mostly affects white men. It occurs in 2 of every 10,000 people and is more common after age 40, according to the National Library of Medicine. Risk factors include cancers, especially lung and colon cancer; exposure to toxins, including gold and mercury; infections, including hepatitis B, malaria, syphilis, and endocarditis; certain medications, including penicillamine, trimethadione, and skin-lightening creams; and systemic lupus erythematosus, rheumatoid arthritis, Graves’ disease, and other autoimmune disorders.
"Treatment of MGN depends on the underlying cause of the disease," said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health, in a statement. "This test can help patients get a timely diagnosis for their MGN and aid with earlier treatment."
Test manufacturer EUROIMMUN US submitted data that compared 275 blood samples from patients with presumed pMGN, with 285 samples from patients diagnosed with other kidney diseases including secondary MGN (sMGN) and autoimmune diseases. The test detected pMGN in 77% of the presumed pMGN samples, and gave a false-positive result in less than 1% of the other samples.
The diagnostic test helped distinguish pMGN from sMGN in most of the patients.
The FDA said that the test should not be used alone to diagnose pMGN, but that patients’ symptoms and other laboratory test results should also be considered. A kidney biopsy is required for confirmation, according to the FDA.
On Twitter @aliciaault
The Food and Drug Administration has approved a noninvasive test to determine whether a chronic kidney disease is caused by an autoimmune disease or another cause such as infection.
The EUROIMMUN Anti- PLA2R IFA blood test detects an antibody that is specific to primary membranous glomerulonephritis (pMGN). MGN, a chronic kidney disease, damages the glomeruli; it can lead to kidney failure and transplant. Symptoms include swelling, hypercholesterolemia, hypertension, and an increased predisposition to blood clots.
The condition mostly affects white men. It occurs in 2 of every 10,000 people and is more common after age 40, according to the National Library of Medicine. Risk factors include cancers, especially lung and colon cancer; exposure to toxins, including gold and mercury; infections, including hepatitis B, malaria, syphilis, and endocarditis; certain medications, including penicillamine, trimethadione, and skin-lightening creams; and systemic lupus erythematosus, rheumatoid arthritis, Graves’ disease, and other autoimmune disorders.
"Treatment of MGN depends on the underlying cause of the disease," said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health, in a statement. "This test can help patients get a timely diagnosis for their MGN and aid with earlier treatment."
Test manufacturer EUROIMMUN US submitted data that compared 275 blood samples from patients with presumed pMGN, with 285 samples from patients diagnosed with other kidney diseases including secondary MGN (sMGN) and autoimmune diseases. The test detected pMGN in 77% of the presumed pMGN samples, and gave a false-positive result in less than 1% of the other samples.
The diagnostic test helped distinguish pMGN from sMGN in most of the patients.
The FDA said that the test should not be used alone to diagnose pMGN, but that patients’ symptoms and other laboratory test results should also be considered. A kidney biopsy is required for confirmation, according to the FDA.
On Twitter @aliciaault
Kaiser survey: Many women skipping preventive care
WASHINGTON – A just-released survey conducted last fall shows that low-income women with private insurance or Medicaid were often foregoing preventive care and use of contraceptives, in part due to cost, but also because of a lack of awareness of benefits that were already available under the Affordable Care Act.
The Kaiser Family Foundation conducted the survey of some 3,000 women aged 15-64 years by telephone – in English and Spanish – from September to November 2013. The goal was to get a baseline picture of women’s health care before the ACA was fully implemented in January.
"It’s important to know where we are today, to have a baseline" with which to compare outcomes in the future, after more women have insurance and broader access to benefits, Alina Salganicoff, vice president and director of women’s health policy for the Kaiser Family Foundation, said at a briefing*.
At the time of the survey, many preventive benefits had already been available to a large number of women since 2012. Under the ACA, health plans that had changed since the law went into effect in 2010 were required to cover services such as mammograms, Pap smears, counseling on domestic and interpersonal violence and sexually transmitted infections (STIs), and contraception. Medicaid also has been covering those preventive benefits.
Among the women surveyed, 51% had employer-provided insurance, 9% were on Medicaid, 7% had individual coverage, 6% were on a parent’s policy, 6% were covered by another government program, and 18% were uninsured. When stratified by income, women who were under 200% of the poverty line were more likely to be uninsured (40%) or on Medicaid (21%).
More than a quarter overall (26%) said they’d delayed care in the past year because of cost, and about 20% said they had skipped recommended tests or treatments, or not filled prescriptions. Twenty-eight percent said they had trouble paying medical bills. All of these rates are higher than in a comparable sample of men surveyed by Kaiser.
When it came to knowledge about preventive services, 60% said they knew insurers were required to cover the cost of at least one preventive visit a year with no out-of-pocket costs, and a slightly smaller number were aware that the plans were also required to provide preventive services free of copays, deductibles, or other charges.
About 88% of women with private insurance said they’d had a recent checkup with a doctor, compared with 81% of those with Medicaid. Not surprisingly, fewer uninsured women had a recent checkup – only about 60%. Only about 40% of women said they’d talked with a health provider about a mental health issue. Mental health services are considered an essential benefit under the ACA, but it’s not clear yet what exactly will be covered.
Most women (73%) reported that their usual source of care was a doctor or an HMO; 13% received care in a clinic, but 3% reported the emergency room as their usual source of care.
For screening tests that are covered, rates of use were high for hypertension (92%) but extremely low for colonoscopy – only 39% of all women reported having had the exam at the appropriate interval, with rates dipping to 35% for blacks and 34% for Hispanics.
Women with private insurance were more likely to have visited an ob.gyn. in the past year – at about 70%, compared with 58% of those on Medicaid, and 43% of the uninsured.
Physician counseling varied by insurance status and ethnicity. Clinicians were more likely to discuss sexual history, HIV, and STIs with women on Medicaid, and black and Hispanic women. Of women on Medicaid, 52% said their provider had talked about HIV, compared with only 29% of those with private insurance. The uninsured had the lowest rate of counseling on any of those topics.
Only about 40% of women were tested for an STI, and among those women, half assumed that the test was a routine part of an ob.gyn. exam. It is not, so rates of testing are probably even lower than those being reported by the survey respondents, said Usha Ranji, associate director for women’s health policy at Kaiser, who was also an author of the survey.
Even though contraceptives are required to be covered by most health plans, 20% of those surveyed said they were not using any contraception. In part, that may be because condoms were reported as the primary method for all women, but especially for those under age 25, and for black women. Condoms are not reimbursed by any plan.
Among women who did use contraception, 32% said it was fully covered by insurance, 31% said it was partially covered, 10% said it was covered by Medicaid, and 18% said they did not have coverage.
The survey was conducted among a nationally representative random digit dial telephone sample, and a shorter companion survey with a nationally representative sample of 700 men aged 18-64 years was conducted at the same time. The margin of sampling error was plus or minus 3 percentage points for the full sample of women and plus or minus 4 percentage points for men.
[email protected]
On Twitter @aliciaault
*Correction, 7/9/2014: An earlier version of this article misstated Alina Salganicoff's name.
WASHINGTON – A just-released survey conducted last fall shows that low-income women with private insurance or Medicaid were often foregoing preventive care and use of contraceptives, in part due to cost, but also because of a lack of awareness of benefits that were already available under the Affordable Care Act.
The Kaiser Family Foundation conducted the survey of some 3,000 women aged 15-64 years by telephone – in English and Spanish – from September to November 2013. The goal was to get a baseline picture of women’s health care before the ACA was fully implemented in January.
"It’s important to know where we are today, to have a baseline" with which to compare outcomes in the future, after more women have insurance and broader access to benefits, Alina Salganicoff, vice president and director of women’s health policy for the Kaiser Family Foundation, said at a briefing*.
At the time of the survey, many preventive benefits had already been available to a large number of women since 2012. Under the ACA, health plans that had changed since the law went into effect in 2010 were required to cover services such as mammograms, Pap smears, counseling on domestic and interpersonal violence and sexually transmitted infections (STIs), and contraception. Medicaid also has been covering those preventive benefits.
Among the women surveyed, 51% had employer-provided insurance, 9% were on Medicaid, 7% had individual coverage, 6% were on a parent’s policy, 6% were covered by another government program, and 18% were uninsured. When stratified by income, women who were under 200% of the poverty line were more likely to be uninsured (40%) or on Medicaid (21%).
More than a quarter overall (26%) said they’d delayed care in the past year because of cost, and about 20% said they had skipped recommended tests or treatments, or not filled prescriptions. Twenty-eight percent said they had trouble paying medical bills. All of these rates are higher than in a comparable sample of men surveyed by Kaiser.
When it came to knowledge about preventive services, 60% said they knew insurers were required to cover the cost of at least one preventive visit a year with no out-of-pocket costs, and a slightly smaller number were aware that the plans were also required to provide preventive services free of copays, deductibles, or other charges.
About 88% of women with private insurance said they’d had a recent checkup with a doctor, compared with 81% of those with Medicaid. Not surprisingly, fewer uninsured women had a recent checkup – only about 60%. Only about 40% of women said they’d talked with a health provider about a mental health issue. Mental health services are considered an essential benefit under the ACA, but it’s not clear yet what exactly will be covered.
Most women (73%) reported that their usual source of care was a doctor or an HMO; 13% received care in a clinic, but 3% reported the emergency room as their usual source of care.
For screening tests that are covered, rates of use were high for hypertension (92%) but extremely low for colonoscopy – only 39% of all women reported having had the exam at the appropriate interval, with rates dipping to 35% for blacks and 34% for Hispanics.
Women with private insurance were more likely to have visited an ob.gyn. in the past year – at about 70%, compared with 58% of those on Medicaid, and 43% of the uninsured.
Physician counseling varied by insurance status and ethnicity. Clinicians were more likely to discuss sexual history, HIV, and STIs with women on Medicaid, and black and Hispanic women. Of women on Medicaid, 52% said their provider had talked about HIV, compared with only 29% of those with private insurance. The uninsured had the lowest rate of counseling on any of those topics.
Only about 40% of women were tested for an STI, and among those women, half assumed that the test was a routine part of an ob.gyn. exam. It is not, so rates of testing are probably even lower than those being reported by the survey respondents, said Usha Ranji, associate director for women’s health policy at Kaiser, who was also an author of the survey.
Even though contraceptives are required to be covered by most health plans, 20% of those surveyed said they were not using any contraception. In part, that may be because condoms were reported as the primary method for all women, but especially for those under age 25, and for black women. Condoms are not reimbursed by any plan.
Among women who did use contraception, 32% said it was fully covered by insurance, 31% said it was partially covered, 10% said it was covered by Medicaid, and 18% said they did not have coverage.
The survey was conducted among a nationally representative random digit dial telephone sample, and a shorter companion survey with a nationally representative sample of 700 men aged 18-64 years was conducted at the same time. The margin of sampling error was plus or minus 3 percentage points for the full sample of women and plus or minus 4 percentage points for men.
[email protected]
On Twitter @aliciaault
*Correction, 7/9/2014: An earlier version of this article misstated Alina Salganicoff's name.
WASHINGTON – A just-released survey conducted last fall shows that low-income women with private insurance or Medicaid were often foregoing preventive care and use of contraceptives, in part due to cost, but also because of a lack of awareness of benefits that were already available under the Affordable Care Act.
The Kaiser Family Foundation conducted the survey of some 3,000 women aged 15-64 years by telephone – in English and Spanish – from September to November 2013. The goal was to get a baseline picture of women’s health care before the ACA was fully implemented in January.
"It’s important to know where we are today, to have a baseline" with which to compare outcomes in the future, after more women have insurance and broader access to benefits, Alina Salganicoff, vice president and director of women’s health policy for the Kaiser Family Foundation, said at a briefing*.
At the time of the survey, many preventive benefits had already been available to a large number of women since 2012. Under the ACA, health plans that had changed since the law went into effect in 2010 were required to cover services such as mammograms, Pap smears, counseling on domestic and interpersonal violence and sexually transmitted infections (STIs), and contraception. Medicaid also has been covering those preventive benefits.
Among the women surveyed, 51% had employer-provided insurance, 9% were on Medicaid, 7% had individual coverage, 6% were on a parent’s policy, 6% were covered by another government program, and 18% were uninsured. When stratified by income, women who were under 200% of the poverty line were more likely to be uninsured (40%) or on Medicaid (21%).
More than a quarter overall (26%) said they’d delayed care in the past year because of cost, and about 20% said they had skipped recommended tests or treatments, or not filled prescriptions. Twenty-eight percent said they had trouble paying medical bills. All of these rates are higher than in a comparable sample of men surveyed by Kaiser.
When it came to knowledge about preventive services, 60% said they knew insurers were required to cover the cost of at least one preventive visit a year with no out-of-pocket costs, and a slightly smaller number were aware that the plans were also required to provide preventive services free of copays, deductibles, or other charges.
About 88% of women with private insurance said they’d had a recent checkup with a doctor, compared with 81% of those with Medicaid. Not surprisingly, fewer uninsured women had a recent checkup – only about 60%. Only about 40% of women said they’d talked with a health provider about a mental health issue. Mental health services are considered an essential benefit under the ACA, but it’s not clear yet what exactly will be covered.
Most women (73%) reported that their usual source of care was a doctor or an HMO; 13% received care in a clinic, but 3% reported the emergency room as their usual source of care.
For screening tests that are covered, rates of use were high for hypertension (92%) but extremely low for colonoscopy – only 39% of all women reported having had the exam at the appropriate interval, with rates dipping to 35% for blacks and 34% for Hispanics.
Women with private insurance were more likely to have visited an ob.gyn. in the past year – at about 70%, compared with 58% of those on Medicaid, and 43% of the uninsured.
Physician counseling varied by insurance status and ethnicity. Clinicians were more likely to discuss sexual history, HIV, and STIs with women on Medicaid, and black and Hispanic women. Of women on Medicaid, 52% said their provider had talked about HIV, compared with only 29% of those with private insurance. The uninsured had the lowest rate of counseling on any of those topics.
Only about 40% of women were tested for an STI, and among those women, half assumed that the test was a routine part of an ob.gyn. exam. It is not, so rates of testing are probably even lower than those being reported by the survey respondents, said Usha Ranji, associate director for women’s health policy at Kaiser, who was also an author of the survey.
Even though contraceptives are required to be covered by most health plans, 20% of those surveyed said they were not using any contraception. In part, that may be because condoms were reported as the primary method for all women, but especially for those under age 25, and for black women. Condoms are not reimbursed by any plan.
Among women who did use contraception, 32% said it was fully covered by insurance, 31% said it was partially covered, 10% said it was covered by Medicaid, and 18% said they did not have coverage.
The survey was conducted among a nationally representative random digit dial telephone sample, and a shorter companion survey with a nationally representative sample of 700 men aged 18-64 years was conducted at the same time. The margin of sampling error was plus or minus 3 percentage points for the full sample of women and plus or minus 4 percentage points for men.
[email protected]
On Twitter @aliciaault
*Correction, 7/9/2014: An earlier version of this article misstated Alina Salganicoff's name.
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
