ACP: Family Caregivers Deserve Doctors' Support

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ACP: Family Caregivers Deserve Doctors' Support

The 37 million “family caregivers” who care for chronically ill patients in the United States have become “an integral part of the health care system” and deserve recognition from physicians for that role.

That's from a position paper issued by the American College of Physicians and endorsed by 10 professional medical societies, including the Society of General Internal Medicine, the American Academy of Hospice and Palliative Medicine, the American College of Osteopathic Internists, and the American Geriatrics Society.

Family caregivers—defined broadly as relatives, partners, friends, and neighbors—provide care for 90% of dependent community-dwelling patients with acute and chronic physical illnesses, cognitive impairment, and/or mental health conditions, according to the authors (J. Gen. Intern. Med. 2010 Jan. 12 [Epub doi:10.1007/s11606-009-1206-3

“Coping with physical, emotional, spiritual and financial challenges affects caregiver health and quality of life as well as patients' health and quality of life,” they wrote.

Dr. Virginia Hood, chair of the ACP's Ethics, Professionalism, and Human Rights Committee and coauthor of the paper, agreed. “Family caregivers are often the one constant the patient can count on to help coordinate care, navigate systems, communicate with multiple health care professionals, [and] be the repository of accurate health care information … especially for people with chronic diseases,” she said in an interview.

“As physicians we need to understand and ensure that ethical principles of medical practice are relevant to and reflect the roles of all team members, including family caregivers, as well as teams themselves, as we try to improve care for our patients,” Dr. Hood added.

According to the report, “physician accessibility and excellent communication are fundamental to supporting the patient and family caregiver”—a potentially difficult mandate, given the current climate of rushed office visits and time constrictions.

For example, the authors cite a 2001 survey conducted by the Alzheimer's Association that showed that although most family caregivers want information regarding what they can expect as the disease progresses, just 38% reported that the physician provided it (www.alz.org/national/documents/alzheimerreport.pdf

“Physicians' use of medical jargon and technical terminology can be confusing to family members,” the ACP authors added. Advance care planning is also crucial, but “patients generally wait for the physician to initiate” these discussions.

Nor should physicians be overly concerned about privacy laws like the Health Insurance Portability and Accountability Act (HIPAA), which states that health professionals “may share relevant health care information with the family caregiver if the patient agrees to, or does not object to, the disclosure,” the authors pointed out.

The paper also emphasizes the need to provide emotional support to family caregivers. “Caregivers experience significantly less depression when the physician listens to their needs and concerns, and validates the importance of the caregiving role,” the authors wrote. Physicians should “be alert for signs of distress … and suggest appropriate referrals.”

“Medical schools are emphasizing new models of care and medical ethics more than ever before, but will need to continue to evolve programs to address these issues,” Dr. Hood said. “Caregivers do not always feel valued by the doctors. We as physicians need to recognize and acknowledge the enormous importance of family caregivers' contributions to the patient's well-being, as well as the caregivers' own stresses and needs, and work to improve communications.”

Disclosures: Dr. Hood disclosed receiving funding from the American Medical Group Association and the pharmaceutical firm Daiichi Sankyo, and another author disclosed receiving royalties from Springer Publishing. No other conflicts were disclosed.

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The 37 million “family caregivers” who care for chronically ill patients in the United States have become “an integral part of the health care system” and deserve recognition from physicians for that role.

That's from a position paper issued by the American College of Physicians and endorsed by 10 professional medical societies, including the Society of General Internal Medicine, the American Academy of Hospice and Palliative Medicine, the American College of Osteopathic Internists, and the American Geriatrics Society.

Family caregivers—defined broadly as relatives, partners, friends, and neighbors—provide care for 90% of dependent community-dwelling patients with acute and chronic physical illnesses, cognitive impairment, and/or mental health conditions, according to the authors (J. Gen. Intern. Med. 2010 Jan. 12 [Epub doi:10.1007/s11606-009-1206-3

“Coping with physical, emotional, spiritual and financial challenges affects caregiver health and quality of life as well as patients' health and quality of life,” they wrote.

Dr. Virginia Hood, chair of the ACP's Ethics, Professionalism, and Human Rights Committee and coauthor of the paper, agreed. “Family caregivers are often the one constant the patient can count on to help coordinate care, navigate systems, communicate with multiple health care professionals, [and] be the repository of accurate health care information … especially for people with chronic diseases,” she said in an interview.

“As physicians we need to understand and ensure that ethical principles of medical practice are relevant to and reflect the roles of all team members, including family caregivers, as well as teams themselves, as we try to improve care for our patients,” Dr. Hood added.

According to the report, “physician accessibility and excellent communication are fundamental to supporting the patient and family caregiver”—a potentially difficult mandate, given the current climate of rushed office visits and time constrictions.

For example, the authors cite a 2001 survey conducted by the Alzheimer's Association that showed that although most family caregivers want information regarding what they can expect as the disease progresses, just 38% reported that the physician provided it (www.alz.org/national/documents/alzheimerreport.pdf

“Physicians' use of medical jargon and technical terminology can be confusing to family members,” the ACP authors added. Advance care planning is also crucial, but “patients generally wait for the physician to initiate” these discussions.

Nor should physicians be overly concerned about privacy laws like the Health Insurance Portability and Accountability Act (HIPAA), which states that health professionals “may share relevant health care information with the family caregiver if the patient agrees to, or does not object to, the disclosure,” the authors pointed out.

The paper also emphasizes the need to provide emotional support to family caregivers. “Caregivers experience significantly less depression when the physician listens to their needs and concerns, and validates the importance of the caregiving role,” the authors wrote. Physicians should “be alert for signs of distress … and suggest appropriate referrals.”

“Medical schools are emphasizing new models of care and medical ethics more than ever before, but will need to continue to evolve programs to address these issues,” Dr. Hood said. “Caregivers do not always feel valued by the doctors. We as physicians need to recognize and acknowledge the enormous importance of family caregivers' contributions to the patient's well-being, as well as the caregivers' own stresses and needs, and work to improve communications.”

Disclosures: Dr. Hood disclosed receiving funding from the American Medical Group Association and the pharmaceutical firm Daiichi Sankyo, and another author disclosed receiving royalties from Springer Publishing. No other conflicts were disclosed.

The 37 million “family caregivers” who care for chronically ill patients in the United States have become “an integral part of the health care system” and deserve recognition from physicians for that role.

That's from a position paper issued by the American College of Physicians and endorsed by 10 professional medical societies, including the Society of General Internal Medicine, the American Academy of Hospice and Palliative Medicine, the American College of Osteopathic Internists, and the American Geriatrics Society.

Family caregivers—defined broadly as relatives, partners, friends, and neighbors—provide care for 90% of dependent community-dwelling patients with acute and chronic physical illnesses, cognitive impairment, and/or mental health conditions, according to the authors (J. Gen. Intern. Med. 2010 Jan. 12 [Epub doi:10.1007/s11606-009-1206-3

“Coping with physical, emotional, spiritual and financial challenges affects caregiver health and quality of life as well as patients' health and quality of life,” they wrote.

Dr. Virginia Hood, chair of the ACP's Ethics, Professionalism, and Human Rights Committee and coauthor of the paper, agreed. “Family caregivers are often the one constant the patient can count on to help coordinate care, navigate systems, communicate with multiple health care professionals, [and] be the repository of accurate health care information … especially for people with chronic diseases,” she said in an interview.

“As physicians we need to understand and ensure that ethical principles of medical practice are relevant to and reflect the roles of all team members, including family caregivers, as well as teams themselves, as we try to improve care for our patients,” Dr. Hood added.

According to the report, “physician accessibility and excellent communication are fundamental to supporting the patient and family caregiver”—a potentially difficult mandate, given the current climate of rushed office visits and time constrictions.

For example, the authors cite a 2001 survey conducted by the Alzheimer's Association that showed that although most family caregivers want information regarding what they can expect as the disease progresses, just 38% reported that the physician provided it (www.alz.org/national/documents/alzheimerreport.pdf

“Physicians' use of medical jargon and technical terminology can be confusing to family members,” the ACP authors added. Advance care planning is also crucial, but “patients generally wait for the physician to initiate” these discussions.

Nor should physicians be overly concerned about privacy laws like the Health Insurance Portability and Accountability Act (HIPAA), which states that health professionals “may share relevant health care information with the family caregiver if the patient agrees to, or does not object to, the disclosure,” the authors pointed out.

The paper also emphasizes the need to provide emotional support to family caregivers. “Caregivers experience significantly less depression when the physician listens to their needs and concerns, and validates the importance of the caregiving role,” the authors wrote. Physicians should “be alert for signs of distress … and suggest appropriate referrals.”

“Medical schools are emphasizing new models of care and medical ethics more than ever before, but will need to continue to evolve programs to address these issues,” Dr. Hood said. “Caregivers do not always feel valued by the doctors. We as physicians need to recognize and acknowledge the enormous importance of family caregivers' contributions to the patient's well-being, as well as the caregivers' own stresses and needs, and work to improve communications.”

Disclosures: Dr. Hood disclosed receiving funding from the American Medical Group Association and the pharmaceutical firm Daiichi Sankyo, and another author disclosed receiving royalties from Springer Publishing. No other conflicts were disclosed.

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Part D 'Doughnut Hole' Raises Costs, Lowers Adherence

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Part D 'Doughnut Hole' Raises Costs, Lowers Adherence

Diabetes patients without coverage of the Medicare Part D “doughnut hole” spent more out of pocket on their medications and had worse adherence compared with diabetes patients who had coverage.

Modified doughnut-hole coverage of generic drugs conferred only “modest differences in out-of-pocket spending and no differences in adherence” compared with diabetes patients without any coverage at all, according to a recent study.

The so-called doughnut hole refers to a coverage gap built into Medicare Part D (prescription drug coverage). Beneficiaries pay only a copayment for their drugs until the total cost reaches a certain threshold. Once costs hit that level, they pay 100% of their costs until their out-of-pocket expenses reach a second, higher amount, and catastrophic coverage kicks in.

In 2006, the Medicare Advantage Prescription Drug (MAPD) plans on which the current study was based had a coverage gap that began at $2,250, and persisted until out-of-pocket expenses hit $3,600; in 2010, the doughnut hole goes from $2,830 to $4,550.

The study, led by Vicki Fung, Ph.D., of the Kaiser Permanente Medical Care Program, in Oakland, Calif., compared diabetes patients in a staff-model, integrated health maintenance organization's MAPD plan. In the first group were 16,654 patients whose Part D plan provided no coverage in the doughnut hole; in the second were 12,126 with employer-supplemented insurance offering some coverage in the gap.

Patients were aged at least 65 years, had been covered at least from Jan. 1, 2005, through Dec. 31, 2006, and had one or more oral diabetes prescriptions dispensed in 2005. Those with dual Medicare/Medicaid coverage and those receiving a low-income Medicare subsidy were excluded.

A total of 17% of patients without gap coverage had out-of-pocket drug expenses of at least $2,250—putting them into the doughnut hole—as did 35% of those with some gap coverage. Patients without gap coverage had lower annual total drug costs, on average: $1,750, versus $1,802 for patients with employer-supplemented gap coverage, the researchers found. However, patients without gap coverage spent significantly more than did their covered counterparts: an average of $806 annually versus $279, a 189% increase (Health Serv. Res. 2010 Jan. 7 [doi:10.1111/j.1475-6773.2009.01071.x

Additionally, patients without gap coverage had an adherence rate of 62%, compared with 66% among patients with coverage. (Adherence was defined as having been dispensed enough drugs to cover greater than or equal to 80% of days prescribed.)

“Our findings reinforce the need to examine carefully the clinical and economic effects of all Part D drug benefit and delivery structures,” they said.

The authors declared no conflicts, and said MAPD plan administrators reviewed the paper but had no control over design, conduct, or interpretation of the study.

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Diabetes patients without coverage of the Medicare Part D “doughnut hole” spent more out of pocket on their medications and had worse adherence compared with diabetes patients who had coverage.

Modified doughnut-hole coverage of generic drugs conferred only “modest differences in out-of-pocket spending and no differences in adherence” compared with diabetes patients without any coverage at all, according to a recent study.

The so-called doughnut hole refers to a coverage gap built into Medicare Part D (prescription drug coverage). Beneficiaries pay only a copayment for their drugs until the total cost reaches a certain threshold. Once costs hit that level, they pay 100% of their costs until their out-of-pocket expenses reach a second, higher amount, and catastrophic coverage kicks in.

In 2006, the Medicare Advantage Prescription Drug (MAPD) plans on which the current study was based had a coverage gap that began at $2,250, and persisted until out-of-pocket expenses hit $3,600; in 2010, the doughnut hole goes from $2,830 to $4,550.

The study, led by Vicki Fung, Ph.D., of the Kaiser Permanente Medical Care Program, in Oakland, Calif., compared diabetes patients in a staff-model, integrated health maintenance organization's MAPD plan. In the first group were 16,654 patients whose Part D plan provided no coverage in the doughnut hole; in the second were 12,126 with employer-supplemented insurance offering some coverage in the gap.

Patients were aged at least 65 years, had been covered at least from Jan. 1, 2005, through Dec. 31, 2006, and had one or more oral diabetes prescriptions dispensed in 2005. Those with dual Medicare/Medicaid coverage and those receiving a low-income Medicare subsidy were excluded.

A total of 17% of patients without gap coverage had out-of-pocket drug expenses of at least $2,250—putting them into the doughnut hole—as did 35% of those with some gap coverage. Patients without gap coverage had lower annual total drug costs, on average: $1,750, versus $1,802 for patients with employer-supplemented gap coverage, the researchers found. However, patients without gap coverage spent significantly more than did their covered counterparts: an average of $806 annually versus $279, a 189% increase (Health Serv. Res. 2010 Jan. 7 [doi:10.1111/j.1475-6773.2009.01071.x

Additionally, patients without gap coverage had an adherence rate of 62%, compared with 66% among patients with coverage. (Adherence was defined as having been dispensed enough drugs to cover greater than or equal to 80% of days prescribed.)

“Our findings reinforce the need to examine carefully the clinical and economic effects of all Part D drug benefit and delivery structures,” they said.

The authors declared no conflicts, and said MAPD plan administrators reviewed the paper but had no control over design, conduct, or interpretation of the study.

Diabetes patients without coverage of the Medicare Part D “doughnut hole” spent more out of pocket on their medications and had worse adherence compared with diabetes patients who had coverage.

Modified doughnut-hole coverage of generic drugs conferred only “modest differences in out-of-pocket spending and no differences in adherence” compared with diabetes patients without any coverage at all, according to a recent study.

The so-called doughnut hole refers to a coverage gap built into Medicare Part D (prescription drug coverage). Beneficiaries pay only a copayment for their drugs until the total cost reaches a certain threshold. Once costs hit that level, they pay 100% of their costs until their out-of-pocket expenses reach a second, higher amount, and catastrophic coverage kicks in.

In 2006, the Medicare Advantage Prescription Drug (MAPD) plans on which the current study was based had a coverage gap that began at $2,250, and persisted until out-of-pocket expenses hit $3,600; in 2010, the doughnut hole goes from $2,830 to $4,550.

The study, led by Vicki Fung, Ph.D., of the Kaiser Permanente Medical Care Program, in Oakland, Calif., compared diabetes patients in a staff-model, integrated health maintenance organization's MAPD plan. In the first group were 16,654 patients whose Part D plan provided no coverage in the doughnut hole; in the second were 12,126 with employer-supplemented insurance offering some coverage in the gap.

Patients were aged at least 65 years, had been covered at least from Jan. 1, 2005, through Dec. 31, 2006, and had one or more oral diabetes prescriptions dispensed in 2005. Those with dual Medicare/Medicaid coverage and those receiving a low-income Medicare subsidy were excluded.

A total of 17% of patients without gap coverage had out-of-pocket drug expenses of at least $2,250—putting them into the doughnut hole—as did 35% of those with some gap coverage. Patients without gap coverage had lower annual total drug costs, on average: $1,750, versus $1,802 for patients with employer-supplemented gap coverage, the researchers found. However, patients without gap coverage spent significantly more than did their covered counterparts: an average of $806 annually versus $279, a 189% increase (Health Serv. Res. 2010 Jan. 7 [doi:10.1111/j.1475-6773.2009.01071.x

Additionally, patients without gap coverage had an adherence rate of 62%, compared with 66% among patients with coverage. (Adherence was defined as having been dispensed enough drugs to cover greater than or equal to 80% of days prescribed.)

“Our findings reinforce the need to examine carefully the clinical and economic effects of all Part D drug benefit and delivery structures,” they said.

The authors declared no conflicts, and said MAPD plan administrators reviewed the paper but had no control over design, conduct, or interpretation of the study.

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In Diabetes, Silent Cerebral Infarcts May Predict End-Stage Renal Disease

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In Diabetes, Silent Cerebral Infarcts May Predict End-Stage Renal Disease

Microvascular disease of the brain as seen on MRI is a good predictor of end-stage renal disease in diabetes and might serve as a proxy for hard-to-detect renal vessel damage.

Currently, no established method exists for assessing small vessel disease in the kidney, according to a report by Dr. Takashi Uzu of Shiga University School of Medical Science in Otsu, Japan, and colleagues.

However, “The vascular beds of the kidney and brain have similar hemodynamic properties,” Dr. Uzu and colleagues wrote (J. Am. Soc. Nephrol. 2010 Jan. 28 [doi: 10.1681/ASN.2009050558

The researchers looked at 608 Japanese patients aged 30-75 years with type 2 diabetes who had been hospitalized to control glucose or to examine their diabetic complications. Patients were excluded if they had a past history of cerebrovascular or cardiovascular events, including MI and heart failure.

All patients underwent MRI of the brain at baseline. A total of 177 patients were found to have had a “silent cerebral infarct” (SCI), defined as “evidence of one or more infarcts on MRI, without a history of stroke or transient ischemic attack.”

Compared with the patients who showed no evidence of past SCI (431), the SCI group had longer diabetes duration (mean of 9.8 years vs. 7.6 years), were older (63.3 years vs. 57.3 years), and had higher blood pressure (the SCI patients had a systolic mean pressure of 146.8 mm Hg vs. 136.5 mm Hg in the non-SCI group; their diastolic mean was 81.6 mm Hg vs. 78.8 mm Hg).

“Over the average 7.5-year follow-up period, 58 patients (34 in the SCI group and 24 in the non-SCI group) reached the primary composite end point of ESRD or death,” the authors wrote. That amounted to a hazard ratio of 2.44.

The likelihood of meeting the study's secondary end point—dialysis plus two serum creatinine values that were twice the baseline values—also was significantly greater in the SCI group compared with the non-SCI group (HR 4.79).

The frequency of patients being treated with renin-angiotensin system–blocking agents, which might lead to renal impairment as an adverse effect, was higher in the SCI group.

“However, the frequency of the primary (ESRD or death) and secondary (the composite of any dialysis and doubling of the serum [creatinine] concentration) end points did not differ” between SCI patients who were treated with RAS-blockers and those who were not, they wrote.

The findings suggest that “the presence of extrarenal microvascular diseases” might be a new predictor of renal function in type 2 diabetes patients.

The authors disclosed no conflicts of interest related to this study.

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Microvascular disease of the brain as seen on MRI is a good predictor of end-stage renal disease in diabetes and might serve as a proxy for hard-to-detect renal vessel damage.

Currently, no established method exists for assessing small vessel disease in the kidney, according to a report by Dr. Takashi Uzu of Shiga University School of Medical Science in Otsu, Japan, and colleagues.

However, “The vascular beds of the kidney and brain have similar hemodynamic properties,” Dr. Uzu and colleagues wrote (J. Am. Soc. Nephrol. 2010 Jan. 28 [doi: 10.1681/ASN.2009050558

The researchers looked at 608 Japanese patients aged 30-75 years with type 2 diabetes who had been hospitalized to control glucose or to examine their diabetic complications. Patients were excluded if they had a past history of cerebrovascular or cardiovascular events, including MI and heart failure.

All patients underwent MRI of the brain at baseline. A total of 177 patients were found to have had a “silent cerebral infarct” (SCI), defined as “evidence of one or more infarcts on MRI, without a history of stroke or transient ischemic attack.”

Compared with the patients who showed no evidence of past SCI (431), the SCI group had longer diabetes duration (mean of 9.8 years vs. 7.6 years), were older (63.3 years vs. 57.3 years), and had higher blood pressure (the SCI patients had a systolic mean pressure of 146.8 mm Hg vs. 136.5 mm Hg in the non-SCI group; their diastolic mean was 81.6 mm Hg vs. 78.8 mm Hg).

“Over the average 7.5-year follow-up period, 58 patients (34 in the SCI group and 24 in the non-SCI group) reached the primary composite end point of ESRD or death,” the authors wrote. That amounted to a hazard ratio of 2.44.

The likelihood of meeting the study's secondary end point—dialysis plus two serum creatinine values that were twice the baseline values—also was significantly greater in the SCI group compared with the non-SCI group (HR 4.79).

The frequency of patients being treated with renin-angiotensin system–blocking agents, which might lead to renal impairment as an adverse effect, was higher in the SCI group.

“However, the frequency of the primary (ESRD or death) and secondary (the composite of any dialysis and doubling of the serum [creatinine] concentration) end points did not differ” between SCI patients who were treated with RAS-blockers and those who were not, they wrote.

The findings suggest that “the presence of extrarenal microvascular diseases” might be a new predictor of renal function in type 2 diabetes patients.

The authors disclosed no conflicts of interest related to this study.

Microvascular disease of the brain as seen on MRI is a good predictor of end-stage renal disease in diabetes and might serve as a proxy for hard-to-detect renal vessel damage.

Currently, no established method exists for assessing small vessel disease in the kidney, according to a report by Dr. Takashi Uzu of Shiga University School of Medical Science in Otsu, Japan, and colleagues.

However, “The vascular beds of the kidney and brain have similar hemodynamic properties,” Dr. Uzu and colleagues wrote (J. Am. Soc. Nephrol. 2010 Jan. 28 [doi: 10.1681/ASN.2009050558

The researchers looked at 608 Japanese patients aged 30-75 years with type 2 diabetes who had been hospitalized to control glucose or to examine their diabetic complications. Patients were excluded if they had a past history of cerebrovascular or cardiovascular events, including MI and heart failure.

All patients underwent MRI of the brain at baseline. A total of 177 patients were found to have had a “silent cerebral infarct” (SCI), defined as “evidence of one or more infarcts on MRI, without a history of stroke or transient ischemic attack.”

Compared with the patients who showed no evidence of past SCI (431), the SCI group had longer diabetes duration (mean of 9.8 years vs. 7.6 years), were older (63.3 years vs. 57.3 years), and had higher blood pressure (the SCI patients had a systolic mean pressure of 146.8 mm Hg vs. 136.5 mm Hg in the non-SCI group; their diastolic mean was 81.6 mm Hg vs. 78.8 mm Hg).

“Over the average 7.5-year follow-up period, 58 patients (34 in the SCI group and 24 in the non-SCI group) reached the primary composite end point of ESRD or death,” the authors wrote. That amounted to a hazard ratio of 2.44.

The likelihood of meeting the study's secondary end point—dialysis plus two serum creatinine values that were twice the baseline values—also was significantly greater in the SCI group compared with the non-SCI group (HR 4.79).

The frequency of patients being treated with renin-angiotensin system–blocking agents, which might lead to renal impairment as an adverse effect, was higher in the SCI group.

“However, the frequency of the primary (ESRD or death) and secondary (the composite of any dialysis and doubling of the serum [creatinine] concentration) end points did not differ” between SCI patients who were treated with RAS-blockers and those who were not, they wrote.

The findings suggest that “the presence of extrarenal microvascular diseases” might be a new predictor of renal function in type 2 diabetes patients.

The authors disclosed no conflicts of interest related to this study.

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Clinical Condition Affects Hearing Loss in Meningitis

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Clinical Condition Affects Hearing Loss in Meningitis

Major Finding: Whether a child with bacterial meningitis had hearing loss depended on patient age and presenting status. Dexamethasone and glycerol treatment did not appear to be helpful.

Data Source: A prospective, randomized double-blind trial of 383 children.

Disclosures: Dr. Peltola disclosed that he currently serves as a clinical scientific consultant for Serum Institute of India Ltd. GlaxoSmithKline organized the first grant for this study. Dr. Yogev and Dr. Pelton said they had no relevant financial disclosures.

Patient age and presenting status—not dexamethasone or glycerol treatment—have the greatest impact on whether a child with bacterial meningitis will develop hearing loss, even in cases due to Haemophilus influenzae type b, according to the largest clinical trial yet to tackle the question.

Indeed, “the effect of the clinical condition was so dramatic that each lowering point in the Glasgow Coma Scale increased the risk of hearing impairment by 15%-20%,” the study authors wrote.

Dr. Heikki Peltola of the division of pediatric infectious diseases at Helsinki University Central Hospital and associates conducted a prospective, randomized double-blind trial of bacterial meningitis patients aged 2 months to 16 years from 10 Latin American institutions (Pediatrics 2010;125:e1-8).

Children included in the study had positive cerebrospinal fluid (CSF) or blood cultures for meningitis, or negative cultures with signs and symptoms of the disease plus three out of four criteria: pleocytosis, a CSF glucose level less than 40 mg/dL, a CSF protein level greater than 40 mg/dL, or a serum C-reactive protein level greater than 40 mg/dL.

Children with a recent head injury, a prior neurologic disease or procedure, immunosuppression, or a known hearing impairment were excluded from the study.

Of the 654 who entered the study, 83 died and 188 were insufficiently tested, leaving 383 children available for analysis.

Most (146) had meningitis due to H. influenzae type b (Hib), followed by S. pneumoniae (70 cases).

All children received ceftriaxone; then 101 children received adjuvant intravenous dexamethasone, 95 received dexamethasone plus glycerol, 92 received glycerol only, and 95 received placebo only.

Mild hearing impairment (between 41 and 59 dB) was detected in 44 children, moderate to severe impairment (between 60 and 79 dB) was detected in 46 children, and severe impairment (80 dB) was detected in 27 children; 15 children became totally deaf.

Regardless of the threshold level, treatments did not differ from each other or placebo in terms of effect on hearing loss.

Nor did etiology correspond to hearing loss.

“Ineffectiveness of all adjuvant medications remained essentially the same when cases with and without a proven etiology were examined,” Dr. Peltola and associates said.

Age, however, did play a role.

“Each increasing month of age decreased the risk of hearing impairment by 2%-6% for any, moderate to severe, and severe impairment,” the physicians noted.

“The controversy about dexamethasone therapy for Streptococcus pneumoniae is well known, but we all believed that the role of dexamethasone in Haemophilus influenzae meningitis had been established,” Dr. Ram Yogev and Dr. Stephen Pelton stated in an accompanying editorial.

“Yet, the data … fail to demonstrate a benefit for dexamethasone in any bacterial meningitis (including H. influenzae) and raise questions about past beliefs,” they said.

In the editorial, Dr. Yogev of the division of pediatric infectious diseases at the Children's Memorial Hospital, Chicago, and Dr. Stephen Pelton of the division of pediatric infectious diseases at Boston University Hospital pointed to the most recent Cochrane meta-analysis, which states that “data support the use of adjunctive corticosteroids in children in high-income countries” (Pediatrics 2010;125;e188-90).

“We suggest that the delay from onset of infection to the start of appropriate therapy (permitting progression of the inflammatory response) is an important contributor to the failure of current adjunctive therapies in resource-limited countries,” they wrote, adding, “If adjunctive therapies are only effective before the inflammatory cascade is operational, they will never be fully successful.”

They also pointed out that the percentage of patients who experienced hearing loss in this study—roughly one-third—is “higher than in many of the studies in which beneficial outcomes with dexamethasone were observed, possibly suggesting a cohort with more advanced disease or a late diagnosis.”

Dr. Yogev and Dr. Pelton concluded with the observation that this study “reminds us that we are still far from preventing many sequelae of childhood bacterial meningitis.”

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Major Finding: Whether a child with bacterial meningitis had hearing loss depended on patient age and presenting status. Dexamethasone and glycerol treatment did not appear to be helpful.

Data Source: A prospective, randomized double-blind trial of 383 children.

Disclosures: Dr. Peltola disclosed that he currently serves as a clinical scientific consultant for Serum Institute of India Ltd. GlaxoSmithKline organized the first grant for this study. Dr. Yogev and Dr. Pelton said they had no relevant financial disclosures.

Patient age and presenting status—not dexamethasone or glycerol treatment—have the greatest impact on whether a child with bacterial meningitis will develop hearing loss, even in cases due to Haemophilus influenzae type b, according to the largest clinical trial yet to tackle the question.

Indeed, “the effect of the clinical condition was so dramatic that each lowering point in the Glasgow Coma Scale increased the risk of hearing impairment by 15%-20%,” the study authors wrote.

Dr. Heikki Peltola of the division of pediatric infectious diseases at Helsinki University Central Hospital and associates conducted a prospective, randomized double-blind trial of bacterial meningitis patients aged 2 months to 16 years from 10 Latin American institutions (Pediatrics 2010;125:e1-8).

Children included in the study had positive cerebrospinal fluid (CSF) or blood cultures for meningitis, or negative cultures with signs and symptoms of the disease plus three out of four criteria: pleocytosis, a CSF glucose level less than 40 mg/dL, a CSF protein level greater than 40 mg/dL, or a serum C-reactive protein level greater than 40 mg/dL.

Children with a recent head injury, a prior neurologic disease or procedure, immunosuppression, or a known hearing impairment were excluded from the study.

Of the 654 who entered the study, 83 died and 188 were insufficiently tested, leaving 383 children available for analysis.

Most (146) had meningitis due to H. influenzae type b (Hib), followed by S. pneumoniae (70 cases).

All children received ceftriaxone; then 101 children received adjuvant intravenous dexamethasone, 95 received dexamethasone plus glycerol, 92 received glycerol only, and 95 received placebo only.

Mild hearing impairment (between 41 and 59 dB) was detected in 44 children, moderate to severe impairment (between 60 and 79 dB) was detected in 46 children, and severe impairment (80 dB) was detected in 27 children; 15 children became totally deaf.

Regardless of the threshold level, treatments did not differ from each other or placebo in terms of effect on hearing loss.

Nor did etiology correspond to hearing loss.

“Ineffectiveness of all adjuvant medications remained essentially the same when cases with and without a proven etiology were examined,” Dr. Peltola and associates said.

Age, however, did play a role.

“Each increasing month of age decreased the risk of hearing impairment by 2%-6% for any, moderate to severe, and severe impairment,” the physicians noted.

“The controversy about dexamethasone therapy for Streptococcus pneumoniae is well known, but we all believed that the role of dexamethasone in Haemophilus influenzae meningitis had been established,” Dr. Ram Yogev and Dr. Stephen Pelton stated in an accompanying editorial.

“Yet, the data … fail to demonstrate a benefit for dexamethasone in any bacterial meningitis (including H. influenzae) and raise questions about past beliefs,” they said.

In the editorial, Dr. Yogev of the division of pediatric infectious diseases at the Children's Memorial Hospital, Chicago, and Dr. Stephen Pelton of the division of pediatric infectious diseases at Boston University Hospital pointed to the most recent Cochrane meta-analysis, which states that “data support the use of adjunctive corticosteroids in children in high-income countries” (Pediatrics 2010;125;e188-90).

“We suggest that the delay from onset of infection to the start of appropriate therapy (permitting progression of the inflammatory response) is an important contributor to the failure of current adjunctive therapies in resource-limited countries,” they wrote, adding, “If adjunctive therapies are only effective before the inflammatory cascade is operational, they will never be fully successful.”

They also pointed out that the percentage of patients who experienced hearing loss in this study—roughly one-third—is “higher than in many of the studies in which beneficial outcomes with dexamethasone were observed, possibly suggesting a cohort with more advanced disease or a late diagnosis.”

Dr. Yogev and Dr. Pelton concluded with the observation that this study “reminds us that we are still far from preventing many sequelae of childhood bacterial meningitis.”

Major Finding: Whether a child with bacterial meningitis had hearing loss depended on patient age and presenting status. Dexamethasone and glycerol treatment did not appear to be helpful.

Data Source: A prospective, randomized double-blind trial of 383 children.

Disclosures: Dr. Peltola disclosed that he currently serves as a clinical scientific consultant for Serum Institute of India Ltd. GlaxoSmithKline organized the first grant for this study. Dr. Yogev and Dr. Pelton said they had no relevant financial disclosures.

Patient age and presenting status—not dexamethasone or glycerol treatment—have the greatest impact on whether a child with bacterial meningitis will develop hearing loss, even in cases due to Haemophilus influenzae type b, according to the largest clinical trial yet to tackle the question.

Indeed, “the effect of the clinical condition was so dramatic that each lowering point in the Glasgow Coma Scale increased the risk of hearing impairment by 15%-20%,” the study authors wrote.

Dr. Heikki Peltola of the division of pediatric infectious diseases at Helsinki University Central Hospital and associates conducted a prospective, randomized double-blind trial of bacterial meningitis patients aged 2 months to 16 years from 10 Latin American institutions (Pediatrics 2010;125:e1-8).

Children included in the study had positive cerebrospinal fluid (CSF) or blood cultures for meningitis, or negative cultures with signs and symptoms of the disease plus three out of four criteria: pleocytosis, a CSF glucose level less than 40 mg/dL, a CSF protein level greater than 40 mg/dL, or a serum C-reactive protein level greater than 40 mg/dL.

Children with a recent head injury, a prior neurologic disease or procedure, immunosuppression, or a known hearing impairment were excluded from the study.

Of the 654 who entered the study, 83 died and 188 were insufficiently tested, leaving 383 children available for analysis.

Most (146) had meningitis due to H. influenzae type b (Hib), followed by S. pneumoniae (70 cases).

All children received ceftriaxone; then 101 children received adjuvant intravenous dexamethasone, 95 received dexamethasone plus glycerol, 92 received glycerol only, and 95 received placebo only.

Mild hearing impairment (between 41 and 59 dB) was detected in 44 children, moderate to severe impairment (between 60 and 79 dB) was detected in 46 children, and severe impairment (80 dB) was detected in 27 children; 15 children became totally deaf.

Regardless of the threshold level, treatments did not differ from each other or placebo in terms of effect on hearing loss.

Nor did etiology correspond to hearing loss.

“Ineffectiveness of all adjuvant medications remained essentially the same when cases with and without a proven etiology were examined,” Dr. Peltola and associates said.

Age, however, did play a role.

“Each increasing month of age decreased the risk of hearing impairment by 2%-6% for any, moderate to severe, and severe impairment,” the physicians noted.

“The controversy about dexamethasone therapy for Streptococcus pneumoniae is well known, but we all believed that the role of dexamethasone in Haemophilus influenzae meningitis had been established,” Dr. Ram Yogev and Dr. Stephen Pelton stated in an accompanying editorial.

“Yet, the data … fail to demonstrate a benefit for dexamethasone in any bacterial meningitis (including H. influenzae) and raise questions about past beliefs,” they said.

In the editorial, Dr. Yogev of the division of pediatric infectious diseases at the Children's Memorial Hospital, Chicago, and Dr. Stephen Pelton of the division of pediatric infectious diseases at Boston University Hospital pointed to the most recent Cochrane meta-analysis, which states that “data support the use of adjunctive corticosteroids in children in high-income countries” (Pediatrics 2010;125;e188-90).

“We suggest that the delay from onset of infection to the start of appropriate therapy (permitting progression of the inflammatory response) is an important contributor to the failure of current adjunctive therapies in resource-limited countries,” they wrote, adding, “If adjunctive therapies are only effective before the inflammatory cascade is operational, they will never be fully successful.”

They also pointed out that the percentage of patients who experienced hearing loss in this study—roughly one-third—is “higher than in many of the studies in which beneficial outcomes with dexamethasone were observed, possibly suggesting a cohort with more advanced disease or a late diagnosis.”

Dr. Yogev and Dr. Pelton concluded with the observation that this study “reminds us that we are still far from preventing many sequelae of childhood bacterial meningitis.”

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'Doughnut Hole' Affects Costs for Diabetes Drugs

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Diabetes patients without coverage of the Medicare Part D “doughnut hole” spent more out-of-pocket on their medications, compared with diabetes patients who had coverage.

Moreover, modified doughnut hole coverage of generic drugs conferred only “modest differences in out-of-pocket spending” compared with diabetes patients without any coverage at all, according to a recent study.

The study, led by Vicki Fung, Ph.D., of the Kaiser Permanente Medical Care Program in Oakland, Calif., compared diabetes patients in a staff-model, integrated HMO Medicare Advantage Prescription Drug (MAPD) plan. In the first group were 16,654 patients whose Part D plan provided no coverage in the doughnut hole; in the second were 12,126 with employer-supplemented insurance offering some coverage in the gap (Health Serv. Res. 2010 Jan. 7 [doi:10.1111/j.1475–6773.2009.01071.x

A total of 17% of patients without gap coverage had out-of-pocket drug expenses of at least $2,250—putting them in the doughnut hole—as did 35% of those with some gap coverage. Patients without gap coverage had lower annual total drug costs, on average: $1,750, versus $1,802 for patients with employer-supplemented gap coverage, the researchers found. However, patients without gap coverage spent significantly more out-of-pocket ($806) than their covered counterparts ($279).

MAPD plan administrators were able to review the paper but had no control over design, conduct, or interpretation of the study.

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Diabetes patients without coverage of the Medicare Part D “doughnut hole” spent more out-of-pocket on their medications, compared with diabetes patients who had coverage.

Moreover, modified doughnut hole coverage of generic drugs conferred only “modest differences in out-of-pocket spending” compared with diabetes patients without any coverage at all, according to a recent study.

The study, led by Vicki Fung, Ph.D., of the Kaiser Permanente Medical Care Program in Oakland, Calif., compared diabetes patients in a staff-model, integrated HMO Medicare Advantage Prescription Drug (MAPD) plan. In the first group were 16,654 patients whose Part D plan provided no coverage in the doughnut hole; in the second were 12,126 with employer-supplemented insurance offering some coverage in the gap (Health Serv. Res. 2010 Jan. 7 [doi:10.1111/j.1475–6773.2009.01071.x

A total of 17% of patients without gap coverage had out-of-pocket drug expenses of at least $2,250—putting them in the doughnut hole—as did 35% of those with some gap coverage. Patients without gap coverage had lower annual total drug costs, on average: $1,750, versus $1,802 for patients with employer-supplemented gap coverage, the researchers found. However, patients without gap coverage spent significantly more out-of-pocket ($806) than their covered counterparts ($279).

MAPD plan administrators were able to review the paper but had no control over design, conduct, or interpretation of the study.

Diabetes patients without coverage of the Medicare Part D “doughnut hole” spent more out-of-pocket on their medications, compared with diabetes patients who had coverage.

Moreover, modified doughnut hole coverage of generic drugs conferred only “modest differences in out-of-pocket spending” compared with diabetes patients without any coverage at all, according to a recent study.

The study, led by Vicki Fung, Ph.D., of the Kaiser Permanente Medical Care Program in Oakland, Calif., compared diabetes patients in a staff-model, integrated HMO Medicare Advantage Prescription Drug (MAPD) plan. In the first group were 16,654 patients whose Part D plan provided no coverage in the doughnut hole; in the second were 12,126 with employer-supplemented insurance offering some coverage in the gap (Health Serv. Res. 2010 Jan. 7 [doi:10.1111/j.1475–6773.2009.01071.x

A total of 17% of patients without gap coverage had out-of-pocket drug expenses of at least $2,250—putting them in the doughnut hole—as did 35% of those with some gap coverage. Patients without gap coverage had lower annual total drug costs, on average: $1,750, versus $1,802 for patients with employer-supplemented gap coverage, the researchers found. However, patients without gap coverage spent significantly more out-of-pocket ($806) than their covered counterparts ($279).

MAPD plan administrators were able to review the paper but had no control over design, conduct, or interpretation of the study.

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Hearing Loss Seen in Meningitis Despite Therapy

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Hearing Loss Seen in Meningitis Despite Therapy

Patient age and presenting status—not dexamethasone or glycerol treatment—have the greatest impact on whether a child with bacterial meningitis will develop hearing loss, even in cases due to Haemophilus influenzae type b, according to the largest clinical trial yet to tackle the question.

Indeed, “the effect of the clinical condition was so dramatic that each lowering point in the Glasgow Coma Scale increased the risk of hearing impairment by 15%-20%,” the study authors wrote.

Dr. Heikki Peltola of Helsinki University Central Hospital and associates conducted a randomized double-blind trial of bacterial meningitis patients aged 2 months to 16 years from 10 Latin American institutions. The children had positive cerebrospinal fluid (CSF) or blood cultures for meningitis, or negative cultures with signs and symptoms of the disease plus three out of four criteria: pleocytosis, a CSF glucose level below 40 mg/dL, a CSF protein level above 40 mg/dL, or a serum C-reactive protein level above 40 mg/dL (Pediatrics 2010;125:e1–8).

Children with a recent head injury, a prior neurologic disease or procedure, immunosuppression, or a known hearing impairment were excluded. Of the 654 who entered the study, 83 died and 188 were insufficiently tested, leaving 383 children available for analysis. Most (146) had meningitis due to H. influenzae type b (Hib), followed by S. pneumoniae (70 cases). All children received ceftriaxone; then 101 children received adjuvant intravenous dexamethasone, 95 received dexamethasone plus glycerol, 92 received glycerol only, and 95 received placebo only.

Mild hearing impairment (41–59 dB) was detected in 44 children, moderate to severe impairment (60–79 dB) was detected in 46 children, and severe impairment (80 dB or more) was detected in 27 children; 15 children became totally deaf.

The treatments did not differ from each other or placebo in terms of effect on hearing loss, and the ineffectiveness of adjuvant medications “remained essentially the same when cases with and without a proven etiology were examined,” Dr. Peltola and associates said.

Age, however, did play a role. “Each increasing month of age decreased the risk of hearing impairment by 2%-6% for any, moderate to severe, and severe impairment,” they noted.

“The controversy about dexamethasone therapy for Streptococcus pneumoniae is well known, but we all believed that the role of dexamethasone in Haemophilus influenzae meningitis had been established,” Dr. Ram Yogev and Dr. Stephen Pelton noted in an editorial. Yet the data “fail to demonstrate a benefit for dexamethasone in any bacterial meningitis.”

In the editorial, Dr. Yogev of Children's Memorial Hospital, Chicago, and Dr. Stephen Pelton of Boston University Hospital noted that the most recent Cochrane meta-analysis states that “data support the use of adjunctive corticosteroids in children in high-income countries” (Pediatrics 2010;125:e188–90).

“We suggest that the delay from onset of infection to the start of appropriate therapy (permitting progression of the inflammatory response) is an important contributor to the failure of current adjunctive therapies in resource-limited countries,” they wrote. “If adjunctive therapies are only effective before the inflammatory cascade is operational, they will never be fully successful.”

The percentage of patients with hearing loss in this study—roughly one-third—is “higher than in many of the studies in which beneficial outcomes with dexamethasone were observed, possibly suggesting a cohort with more advanced disease or late diagnosis,” they said. The study “reminds us that we are still far from preventing many sequelae of childhood bacterial meningitis, Dr. Yogev and Dr. Pelton concluded.

Disclosures: Dr. Peltola's research team disclosed past travel and research support from “various pharmaceutical companies, none of which had any role in this study.” Dr. Peltola serves as a clinical scientific consultant for Serum Institute of India. GlaxoSmithKline organized the first grant for this study. Dr. Yogev and Dr. Pelton said they had no relevant disclosures.

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Patient age and presenting status—not dexamethasone or glycerol treatment—have the greatest impact on whether a child with bacterial meningitis will develop hearing loss, even in cases due to Haemophilus influenzae type b, according to the largest clinical trial yet to tackle the question.

Indeed, “the effect of the clinical condition was so dramatic that each lowering point in the Glasgow Coma Scale increased the risk of hearing impairment by 15%-20%,” the study authors wrote.

Dr. Heikki Peltola of Helsinki University Central Hospital and associates conducted a randomized double-blind trial of bacterial meningitis patients aged 2 months to 16 years from 10 Latin American institutions. The children had positive cerebrospinal fluid (CSF) or blood cultures for meningitis, or negative cultures with signs and symptoms of the disease plus three out of four criteria: pleocytosis, a CSF glucose level below 40 mg/dL, a CSF protein level above 40 mg/dL, or a serum C-reactive protein level above 40 mg/dL (Pediatrics 2010;125:e1–8).

Children with a recent head injury, a prior neurologic disease or procedure, immunosuppression, or a known hearing impairment were excluded. Of the 654 who entered the study, 83 died and 188 were insufficiently tested, leaving 383 children available for analysis. Most (146) had meningitis due to H. influenzae type b (Hib), followed by S. pneumoniae (70 cases). All children received ceftriaxone; then 101 children received adjuvant intravenous dexamethasone, 95 received dexamethasone plus glycerol, 92 received glycerol only, and 95 received placebo only.

Mild hearing impairment (41–59 dB) was detected in 44 children, moderate to severe impairment (60–79 dB) was detected in 46 children, and severe impairment (80 dB or more) was detected in 27 children; 15 children became totally deaf.

The treatments did not differ from each other or placebo in terms of effect on hearing loss, and the ineffectiveness of adjuvant medications “remained essentially the same when cases with and without a proven etiology were examined,” Dr. Peltola and associates said.

Age, however, did play a role. “Each increasing month of age decreased the risk of hearing impairment by 2%-6% for any, moderate to severe, and severe impairment,” they noted.

“The controversy about dexamethasone therapy for Streptococcus pneumoniae is well known, but we all believed that the role of dexamethasone in Haemophilus influenzae meningitis had been established,” Dr. Ram Yogev and Dr. Stephen Pelton noted in an editorial. Yet the data “fail to demonstrate a benefit for dexamethasone in any bacterial meningitis.”

In the editorial, Dr. Yogev of Children's Memorial Hospital, Chicago, and Dr. Stephen Pelton of Boston University Hospital noted that the most recent Cochrane meta-analysis states that “data support the use of adjunctive corticosteroids in children in high-income countries” (Pediatrics 2010;125:e188–90).

“We suggest that the delay from onset of infection to the start of appropriate therapy (permitting progression of the inflammatory response) is an important contributor to the failure of current adjunctive therapies in resource-limited countries,” they wrote. “If adjunctive therapies are only effective before the inflammatory cascade is operational, they will never be fully successful.”

The percentage of patients with hearing loss in this study—roughly one-third—is “higher than in many of the studies in which beneficial outcomes with dexamethasone were observed, possibly suggesting a cohort with more advanced disease or late diagnosis,” they said. The study “reminds us that we are still far from preventing many sequelae of childhood bacterial meningitis, Dr. Yogev and Dr. Pelton concluded.

Disclosures: Dr. Peltola's research team disclosed past travel and research support from “various pharmaceutical companies, none of which had any role in this study.” Dr. Peltola serves as a clinical scientific consultant for Serum Institute of India. GlaxoSmithKline organized the first grant for this study. Dr. Yogev and Dr. Pelton said they had no relevant disclosures.

Patient age and presenting status—not dexamethasone or glycerol treatment—have the greatest impact on whether a child with bacterial meningitis will develop hearing loss, even in cases due to Haemophilus influenzae type b, according to the largest clinical trial yet to tackle the question.

Indeed, “the effect of the clinical condition was so dramatic that each lowering point in the Glasgow Coma Scale increased the risk of hearing impairment by 15%-20%,” the study authors wrote.

Dr. Heikki Peltola of Helsinki University Central Hospital and associates conducted a randomized double-blind trial of bacterial meningitis patients aged 2 months to 16 years from 10 Latin American institutions. The children had positive cerebrospinal fluid (CSF) or blood cultures for meningitis, or negative cultures with signs and symptoms of the disease plus three out of four criteria: pleocytosis, a CSF glucose level below 40 mg/dL, a CSF protein level above 40 mg/dL, or a serum C-reactive protein level above 40 mg/dL (Pediatrics 2010;125:e1–8).

Children with a recent head injury, a prior neurologic disease or procedure, immunosuppression, or a known hearing impairment were excluded. Of the 654 who entered the study, 83 died and 188 were insufficiently tested, leaving 383 children available for analysis. Most (146) had meningitis due to H. influenzae type b (Hib), followed by S. pneumoniae (70 cases). All children received ceftriaxone; then 101 children received adjuvant intravenous dexamethasone, 95 received dexamethasone plus glycerol, 92 received glycerol only, and 95 received placebo only.

Mild hearing impairment (41–59 dB) was detected in 44 children, moderate to severe impairment (60–79 dB) was detected in 46 children, and severe impairment (80 dB or more) was detected in 27 children; 15 children became totally deaf.

The treatments did not differ from each other or placebo in terms of effect on hearing loss, and the ineffectiveness of adjuvant medications “remained essentially the same when cases with and without a proven etiology were examined,” Dr. Peltola and associates said.

Age, however, did play a role. “Each increasing month of age decreased the risk of hearing impairment by 2%-6% for any, moderate to severe, and severe impairment,” they noted.

“The controversy about dexamethasone therapy for Streptococcus pneumoniae is well known, but we all believed that the role of dexamethasone in Haemophilus influenzae meningitis had been established,” Dr. Ram Yogev and Dr. Stephen Pelton noted in an editorial. Yet the data “fail to demonstrate a benefit for dexamethasone in any bacterial meningitis.”

In the editorial, Dr. Yogev of Children's Memorial Hospital, Chicago, and Dr. Stephen Pelton of Boston University Hospital noted that the most recent Cochrane meta-analysis states that “data support the use of adjunctive corticosteroids in children in high-income countries” (Pediatrics 2010;125:e188–90).

“We suggest that the delay from onset of infection to the start of appropriate therapy (permitting progression of the inflammatory response) is an important contributor to the failure of current adjunctive therapies in resource-limited countries,” they wrote. “If adjunctive therapies are only effective before the inflammatory cascade is operational, they will never be fully successful.”

The percentage of patients with hearing loss in this study—roughly one-third—is “higher than in many of the studies in which beneficial outcomes with dexamethasone were observed, possibly suggesting a cohort with more advanced disease or late diagnosis,” they said. The study “reminds us that we are still far from preventing many sequelae of childhood bacterial meningitis, Dr. Yogev and Dr. Pelton concluded.

Disclosures: Dr. Peltola's research team disclosed past travel and research support from “various pharmaceutical companies, none of which had any role in this study.” Dr. Peltola serves as a clinical scientific consultant for Serum Institute of India. GlaxoSmithKline organized the first grant for this study. Dr. Yogev and Dr. Pelton said they had no relevant disclosures.

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Adherence Goes Down in the 'Doughnut Hole'

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Diabetes patients without coverage of the Medicare Part D “doughnut hole” spent more out of pocket on their medications and had worse medication adherence, compared with diabetes patients who had coverage.

Moreover, modified doughnut hole coverage of generic drugs conferred only “modest differences in out-of-pocket spending and no differences in adherence,” compared with diabetes patients without any coverage at all, according to a recent study.

The so-called doughnut hole refers to a coverage gap built into Medicare Part D (prescription drug coverage). Under Part D, beneficiaries pay only a copayment for their drugs until the total cost reaches a certain threshold. Once costs hit that level, they pay 100% of their drug costs until their out-of-pocket expenses reach a second, higher amount, and catastrophic coverage kicks in.

In 2006, the Medicare Advantage Prescription Drug (MAPD) plans on which the current study was based had a coverage gap that began at $2,250, and persisted until patients' out-of-pocket expenses hit the $3,600 mark; in 2010, the doughnut hole goes from $2,830 to $4,550.

The study, led by Vicki Fung, Ph.D., of the Kaiser Permanente Medical Care Program, in Oakland, Calif., compared diabetes patients in a staff-model, integrated health maintenance organization's (HMO) MAPD plan.

In the first group were 16,654 patients whose Part D plan provided no coverage in the doughnut hole; in the second group were 12,126 with employer-supplemented insurance offering some coverage in the gap.

All patients were at least 65 years old, had been covered under their plan at least from Jan. 1, 2005, through Dec. 31, 2006, and had one or more oral diabetes prescriptions dispensed in 2005. Patients with dual Medicare/Medicaid coverage were excluded, as were patients receiving a low-income Medicare subsidy.

A total of 17% of patients without gap coverage had out-of-pocket drug expenses of at least $2,250—putting them into the doughnut hole—as did 35% of those with some gap coverage. Patients without gap coverage had lower annual total drug costs, on average: $1,750 versus $1,802 for patients with employer-supplemented gap coverage, the researchers found. However, patients without gap coverage spent significantly more out of pocket than did their covered counterparts: an average of $806 annually versus $279, a 189% increase (Health Serv. Res. 2010 Jan. 7 [Epub doi:10.1111/j.1475-6773.2009.01071.x]).

Additionally, patients without gap coverage had a lower adherence rate: 62%, compared with 66% among patients who did have coverage. (Adherence was defined as having been dispensed enough drugs to cover greater than or equal to 80% of days prescribed.)

The researchers also conducted a parallel analysis of a separate, network-model HMO with the same study criteria as above, where 11,034 patients had a coverage gap and 3,950 had coverage of their gap with generic medications only.

In this plan, 34% of subjects with no gap coverage and 37% with gap coverage of generic drugs had out-of-pocket expenses equal to or more than $2,250.

Although adherence was statistically similar among these groups, out-of-pocket costs for patients without gap coverage was still, on average, 14% higher annually than for patients who received coverage of generic medications past the $2,250 threshold.

The Medicare prescription drug program is now entering its fifth year, and 89% of the 22.5 million enrollees in 2006 had no gap coverage, the authors noted.

“Our findings reinforce the need to examine carefully the clinical and economic effects of all Part D drug benefit and delivery structures,” they said.

Disclosures: The authors said that they had no corporate financial disclosures, and that although the MAPD plan administrators were able to review the paper, they had no control over design, conduct, or interpretation of the study.

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Diabetes patients without coverage of the Medicare Part D “doughnut hole” spent more out of pocket on their medications and had worse medication adherence, compared with diabetes patients who had coverage.

Moreover, modified doughnut hole coverage of generic drugs conferred only “modest differences in out-of-pocket spending and no differences in adherence,” compared with diabetes patients without any coverage at all, according to a recent study.

The so-called doughnut hole refers to a coverage gap built into Medicare Part D (prescription drug coverage). Under Part D, beneficiaries pay only a copayment for their drugs until the total cost reaches a certain threshold. Once costs hit that level, they pay 100% of their drug costs until their out-of-pocket expenses reach a second, higher amount, and catastrophic coverage kicks in.

In 2006, the Medicare Advantage Prescription Drug (MAPD) plans on which the current study was based had a coverage gap that began at $2,250, and persisted until patients' out-of-pocket expenses hit the $3,600 mark; in 2010, the doughnut hole goes from $2,830 to $4,550.

The study, led by Vicki Fung, Ph.D., of the Kaiser Permanente Medical Care Program, in Oakland, Calif., compared diabetes patients in a staff-model, integrated health maintenance organization's (HMO) MAPD plan.

In the first group were 16,654 patients whose Part D plan provided no coverage in the doughnut hole; in the second group were 12,126 with employer-supplemented insurance offering some coverage in the gap.

All patients were at least 65 years old, had been covered under their plan at least from Jan. 1, 2005, through Dec. 31, 2006, and had one or more oral diabetes prescriptions dispensed in 2005. Patients with dual Medicare/Medicaid coverage were excluded, as were patients receiving a low-income Medicare subsidy.

A total of 17% of patients without gap coverage had out-of-pocket drug expenses of at least $2,250—putting them into the doughnut hole—as did 35% of those with some gap coverage. Patients without gap coverage had lower annual total drug costs, on average: $1,750 versus $1,802 for patients with employer-supplemented gap coverage, the researchers found. However, patients without gap coverage spent significantly more out of pocket than did their covered counterparts: an average of $806 annually versus $279, a 189% increase (Health Serv. Res. 2010 Jan. 7 [Epub doi:10.1111/j.1475-6773.2009.01071.x]).

Additionally, patients without gap coverage had a lower adherence rate: 62%, compared with 66% among patients who did have coverage. (Adherence was defined as having been dispensed enough drugs to cover greater than or equal to 80% of days prescribed.)

The researchers also conducted a parallel analysis of a separate, network-model HMO with the same study criteria as above, where 11,034 patients had a coverage gap and 3,950 had coverage of their gap with generic medications only.

In this plan, 34% of subjects with no gap coverage and 37% with gap coverage of generic drugs had out-of-pocket expenses equal to or more than $2,250.

Although adherence was statistically similar among these groups, out-of-pocket costs for patients without gap coverage was still, on average, 14% higher annually than for patients who received coverage of generic medications past the $2,250 threshold.

The Medicare prescription drug program is now entering its fifth year, and 89% of the 22.5 million enrollees in 2006 had no gap coverage, the authors noted.

“Our findings reinforce the need to examine carefully the clinical and economic effects of all Part D drug benefit and delivery structures,” they said.

Disclosures: The authors said that they had no corporate financial disclosures, and that although the MAPD plan administrators were able to review the paper, they had no control over design, conduct, or interpretation of the study.

Diabetes patients without coverage of the Medicare Part D “doughnut hole” spent more out of pocket on their medications and had worse medication adherence, compared with diabetes patients who had coverage.

Moreover, modified doughnut hole coverage of generic drugs conferred only “modest differences in out-of-pocket spending and no differences in adherence,” compared with diabetes patients without any coverage at all, according to a recent study.

The so-called doughnut hole refers to a coverage gap built into Medicare Part D (prescription drug coverage). Under Part D, beneficiaries pay only a copayment for their drugs until the total cost reaches a certain threshold. Once costs hit that level, they pay 100% of their drug costs until their out-of-pocket expenses reach a second, higher amount, and catastrophic coverage kicks in.

In 2006, the Medicare Advantage Prescription Drug (MAPD) plans on which the current study was based had a coverage gap that began at $2,250, and persisted until patients' out-of-pocket expenses hit the $3,600 mark; in 2010, the doughnut hole goes from $2,830 to $4,550.

The study, led by Vicki Fung, Ph.D., of the Kaiser Permanente Medical Care Program, in Oakland, Calif., compared diabetes patients in a staff-model, integrated health maintenance organization's (HMO) MAPD plan.

In the first group were 16,654 patients whose Part D plan provided no coverage in the doughnut hole; in the second group were 12,126 with employer-supplemented insurance offering some coverage in the gap.

All patients were at least 65 years old, had been covered under their plan at least from Jan. 1, 2005, through Dec. 31, 2006, and had one or more oral diabetes prescriptions dispensed in 2005. Patients with dual Medicare/Medicaid coverage were excluded, as were patients receiving a low-income Medicare subsidy.

A total of 17% of patients without gap coverage had out-of-pocket drug expenses of at least $2,250—putting them into the doughnut hole—as did 35% of those with some gap coverage. Patients without gap coverage had lower annual total drug costs, on average: $1,750 versus $1,802 for patients with employer-supplemented gap coverage, the researchers found. However, patients without gap coverage spent significantly more out of pocket than did their covered counterparts: an average of $806 annually versus $279, a 189% increase (Health Serv. Res. 2010 Jan. 7 [Epub doi:10.1111/j.1475-6773.2009.01071.x]).

Additionally, patients without gap coverage had a lower adherence rate: 62%, compared with 66% among patients who did have coverage. (Adherence was defined as having been dispensed enough drugs to cover greater than or equal to 80% of days prescribed.)

The researchers also conducted a parallel analysis of a separate, network-model HMO with the same study criteria as above, where 11,034 patients had a coverage gap and 3,950 had coverage of their gap with generic medications only.

In this plan, 34% of subjects with no gap coverage and 37% with gap coverage of generic drugs had out-of-pocket expenses equal to or more than $2,250.

Although adherence was statistically similar among these groups, out-of-pocket costs for patients without gap coverage was still, on average, 14% higher annually than for patients who received coverage of generic medications past the $2,250 threshold.

The Medicare prescription drug program is now entering its fifth year, and 89% of the 22.5 million enrollees in 2006 had no gap coverage, the authors noted.

“Our findings reinforce the need to examine carefully the clinical and economic effects of all Part D drug benefit and delivery structures,” they said.

Disclosures: The authors said that they had no corporate financial disclosures, and that although the MAPD plan administrators were able to review the paper, they had no control over design, conduct, or interpretation of the study.

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Noninvasive CIMT Scan Predicts Poor Myocardial Perfusion

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Noninvasive CIMT Scan Predicts Poor Myocardial Perfusion

Increased carotid intima-media thickness as seen on ultrasound independently predicted abnormal myocardial perfusion in diabetes patients who were otherwise asymptomatic for heart disease.

The finding suggests that “the truly noninvasive, inexpensive, and radiation-free nature of CIMT may represent an important advantage over other suggested screening techniques” for heart disease in diabetes patients.

Led by Dr. Roxana Djaberi of the department of cardiology at Leiden (the Netherlands) University Medical Center, the researchers looked at 98 patients with type 2 diabetes recruited from an outpatient diabetes clinic. All were asymptomatic for heart disease according to the Rose questionnaire (Diabetes Care 2009 Nov. 16 [doi:10.2337/dc09-1301]).

The patients' mean age was 54 years; 51% were male. Overall, the mean summed stress score (SSS) was 3.1, with 34 patients (35%) showing abnormal perfusion on single-photon emission computed tomography imaging (SSS greater than or equal to 3), and 14 patients (14%) showing severely abnormal perfusion (SSS of at least 8). According to Dr. Djaberi, “Abnormal perfusion was present in 9% of patients with normal CIMT versus 75% of patients with increased CIMT [defined as thickness at or above the 75th percentile of reference values].”

Moreover, “severely abnormal perfusion increased from 3% in patients with normal CIMT to 28% in those with increased CIMT,” she added.

The authors cited the lack of a nondiabetic control group as a study limitation.

Nevertheless, “Considering the high global prevalence of type 2 diabetes, a broad screening strategy of all asymptomatic patients using [single-photon emission computed tomography] perfusion imaging does not appear feasible or cost-effective,” concluded the authors.

“Initial risk-stratification using CIMT may allow selective referral of asymptomatic patients with type 2 diabetes requiring further imaging and intensification of therapy,” they added.

The authors received funding from Medtronic, Biotronik, Boston Scientific, Bristol Myers Squibb Medical Imaging, St. Jude Medical, GE Healthcare, Edwards Lifesciences, AstraZeneca, Pfizer, and MSD, an affiliate of Merck.

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Increased carotid intima-media thickness as seen on ultrasound independently predicted abnormal myocardial perfusion in diabetes patients who were otherwise asymptomatic for heart disease.

The finding suggests that “the truly noninvasive, inexpensive, and radiation-free nature of CIMT may represent an important advantage over other suggested screening techniques” for heart disease in diabetes patients.

Led by Dr. Roxana Djaberi of the department of cardiology at Leiden (the Netherlands) University Medical Center, the researchers looked at 98 patients with type 2 diabetes recruited from an outpatient diabetes clinic. All were asymptomatic for heart disease according to the Rose questionnaire (Diabetes Care 2009 Nov. 16 [doi:10.2337/dc09-1301]).

The patients' mean age was 54 years; 51% were male. Overall, the mean summed stress score (SSS) was 3.1, with 34 patients (35%) showing abnormal perfusion on single-photon emission computed tomography imaging (SSS greater than or equal to 3), and 14 patients (14%) showing severely abnormal perfusion (SSS of at least 8). According to Dr. Djaberi, “Abnormal perfusion was present in 9% of patients with normal CIMT versus 75% of patients with increased CIMT [defined as thickness at or above the 75th percentile of reference values].”

Moreover, “severely abnormal perfusion increased from 3% in patients with normal CIMT to 28% in those with increased CIMT,” she added.

The authors cited the lack of a nondiabetic control group as a study limitation.

Nevertheless, “Considering the high global prevalence of type 2 diabetes, a broad screening strategy of all asymptomatic patients using [single-photon emission computed tomography] perfusion imaging does not appear feasible or cost-effective,” concluded the authors.

“Initial risk-stratification using CIMT may allow selective referral of asymptomatic patients with type 2 diabetes requiring further imaging and intensification of therapy,” they added.

The authors received funding from Medtronic, Biotronik, Boston Scientific, Bristol Myers Squibb Medical Imaging, St. Jude Medical, GE Healthcare, Edwards Lifesciences, AstraZeneca, Pfizer, and MSD, an affiliate of Merck.

Increased carotid intima-media thickness as seen on ultrasound independently predicted abnormal myocardial perfusion in diabetes patients who were otherwise asymptomatic for heart disease.

The finding suggests that “the truly noninvasive, inexpensive, and radiation-free nature of CIMT may represent an important advantage over other suggested screening techniques” for heart disease in diabetes patients.

Led by Dr. Roxana Djaberi of the department of cardiology at Leiden (the Netherlands) University Medical Center, the researchers looked at 98 patients with type 2 diabetes recruited from an outpatient diabetes clinic. All were asymptomatic for heart disease according to the Rose questionnaire (Diabetes Care 2009 Nov. 16 [doi:10.2337/dc09-1301]).

The patients' mean age was 54 years; 51% were male. Overall, the mean summed stress score (SSS) was 3.1, with 34 patients (35%) showing abnormal perfusion on single-photon emission computed tomography imaging (SSS greater than or equal to 3), and 14 patients (14%) showing severely abnormal perfusion (SSS of at least 8). According to Dr. Djaberi, “Abnormal perfusion was present in 9% of patients with normal CIMT versus 75% of patients with increased CIMT [defined as thickness at or above the 75th percentile of reference values].”

Moreover, “severely abnormal perfusion increased from 3% in patients with normal CIMT to 28% in those with increased CIMT,” she added.

The authors cited the lack of a nondiabetic control group as a study limitation.

Nevertheless, “Considering the high global prevalence of type 2 diabetes, a broad screening strategy of all asymptomatic patients using [single-photon emission computed tomography] perfusion imaging does not appear feasible or cost-effective,” concluded the authors.

“Initial risk-stratification using CIMT may allow selective referral of asymptomatic patients with type 2 diabetes requiring further imaging and intensification of therapy,” they added.

The authors received funding from Medtronic, Biotronik, Boston Scientific, Bristol Myers Squibb Medical Imaging, St. Jude Medical, GE Healthcare, Edwards Lifesciences, AstraZeneca, Pfizer, and MSD, an affiliate of Merck.

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Calif. Balance-Billing Ban Prompts Lawsuits

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Calif. Balance-Billing Ban Prompts Lawsuits

It was January 2009 when the California Supreme Court prohibited emergency physicians from balance billing the several million patients covered under that state's HMOs and Blue Cross and Blue Shield PPOs.

But now that the dust has settled, class action attorneys are moving in, both to file lawsuits against illegal balance billing that is still taking place and to have the state court's ruling applied retroactively.

For example, Derek Emge, a consumer class-action attorney in San Diego, said his firm is investigating two possible cases of balance billing that occurred after the Supreme Court's ruling. (No lawsuits have been filed.) His firm's Web site warns former emergency department patients that “a hospital or physician group may not bill or contact you about bills arising from emergency medical services. They may not threaten you with debt collection and/or ruining your credit. Any contact about your bill is prohibited” (www.emgelawfirm.com/CM/Custom/Illegal-charges-for-Emergency-Rooms.asp

But that's not really true, said Dr. R. Myles Riner, past president of CAL/ACEP. Ads like the one from Mr. Enge's firm seem to imply that all balance billing is illegal, that patients should never receive any bill from an emergency care provider, and that the Supreme Court decision applies to all insured patients, he said. In reality, by one estimate, the ruling applies to fewer than half of all commercially insured patients.

“But just the existence of these [ads] is likely to discourage patients from paying legitimate bills from emergency care providers that do not fall under the balance-billing prohibition,” such as coinsurance payments and deductibles, added Dr. Riner, director of provider relations for an emergency physician staffing and management company.

Andrew Selesnick, a health care attorney in Los Angeles, agreed. “You're putting out this false information, inaccurate information, and patients don't need much of an excuse not to pay the bill in the first place,” said Mr. Selesnick. “Now they can say, 'You were never allowed to send me a bill.'” Mr. Selesnick has been either lead or co-counsel for the defendants on just about all of the nearly half dozen lawsuits that have taken place so far. Mr. Emge said the Web page was simply intended to alert any patient who was billed for emergency department care that “there may be an issue.”

The essential question for lawsuits that do have standing will be whether the ruling may be applied retroactively, Mr. Selesnick said. Both attorneys agreed that, typically, these types of rulings are applied retroactively—and that could be very bad news for California emergency physician groups, said Mr. Selesnick. “If the court ordered the return of monies, it would be another blow to an already fragile safety net,” he said.

There are also privacy concerns. “How would the court presume to contact potential class members?” Mr. Selesnick asked. “Do they send a letter to the minor who went to the ED but never told her parents? Or do they send a letter to the husband who never informed his wife about a visit to the ED?”

Even if the balance-billing ruling is not given retroactive application, the damage may already be done to emergency care in California, Dr. Riner said. “The overall effect is to significantly increase the burden on ED physician groups to dispute these underpayments—often to no avail—and to adjust to the substantial decrease in revenues,” he added. That will happen by either cutting back on EP staffing, abandoning EDs with payer mixes that cannot support them, or seeking subsidies from hospitals.

“Longer term, the result will likely be longer waits for care in our EDs, poorer quality of care, closure of more EDs in poorer neighborhoods, and more frequent use of nonphysician practitioners to manage even the sickest patients in our EDs,” Dr. Riner said.

Read the full text of the January California Supreme Court ruling at www.calacep.org/spaw2/uploads/files/legal%20advocacy/Prospect_v_Northridge_Supreme_Court_Opinion.pdf

The effect is to increase the burden on ED physician groups to dispute these underpayments, often to no avail.

Source DR. RINER

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It was January 2009 when the California Supreme Court prohibited emergency physicians from balance billing the several million patients covered under that state's HMOs and Blue Cross and Blue Shield PPOs.

But now that the dust has settled, class action attorneys are moving in, both to file lawsuits against illegal balance billing that is still taking place and to have the state court's ruling applied retroactively.

For example, Derek Emge, a consumer class-action attorney in San Diego, said his firm is investigating two possible cases of balance billing that occurred after the Supreme Court's ruling. (No lawsuits have been filed.) His firm's Web site warns former emergency department patients that “a hospital or physician group may not bill or contact you about bills arising from emergency medical services. They may not threaten you with debt collection and/or ruining your credit. Any contact about your bill is prohibited” (www.emgelawfirm.com/CM/Custom/Illegal-charges-for-Emergency-Rooms.asp

But that's not really true, said Dr. R. Myles Riner, past president of CAL/ACEP. Ads like the one from Mr. Enge's firm seem to imply that all balance billing is illegal, that patients should never receive any bill from an emergency care provider, and that the Supreme Court decision applies to all insured patients, he said. In reality, by one estimate, the ruling applies to fewer than half of all commercially insured patients.

“But just the existence of these [ads] is likely to discourage patients from paying legitimate bills from emergency care providers that do not fall under the balance-billing prohibition,” such as coinsurance payments and deductibles, added Dr. Riner, director of provider relations for an emergency physician staffing and management company.

Andrew Selesnick, a health care attorney in Los Angeles, agreed. “You're putting out this false information, inaccurate information, and patients don't need much of an excuse not to pay the bill in the first place,” said Mr. Selesnick. “Now they can say, 'You were never allowed to send me a bill.'” Mr. Selesnick has been either lead or co-counsel for the defendants on just about all of the nearly half dozen lawsuits that have taken place so far. Mr. Emge said the Web page was simply intended to alert any patient who was billed for emergency department care that “there may be an issue.”

The essential question for lawsuits that do have standing will be whether the ruling may be applied retroactively, Mr. Selesnick said. Both attorneys agreed that, typically, these types of rulings are applied retroactively—and that could be very bad news for California emergency physician groups, said Mr. Selesnick. “If the court ordered the return of monies, it would be another blow to an already fragile safety net,” he said.

There are also privacy concerns. “How would the court presume to contact potential class members?” Mr. Selesnick asked. “Do they send a letter to the minor who went to the ED but never told her parents? Or do they send a letter to the husband who never informed his wife about a visit to the ED?”

Even if the balance-billing ruling is not given retroactive application, the damage may already be done to emergency care in California, Dr. Riner said. “The overall effect is to significantly increase the burden on ED physician groups to dispute these underpayments—often to no avail—and to adjust to the substantial decrease in revenues,” he added. That will happen by either cutting back on EP staffing, abandoning EDs with payer mixes that cannot support them, or seeking subsidies from hospitals.

“Longer term, the result will likely be longer waits for care in our EDs, poorer quality of care, closure of more EDs in poorer neighborhoods, and more frequent use of nonphysician practitioners to manage even the sickest patients in our EDs,” Dr. Riner said.

Read the full text of the January California Supreme Court ruling at www.calacep.org/spaw2/uploads/files/legal%20advocacy/Prospect_v_Northridge_Supreme_Court_Opinion.pdf

The effect is to increase the burden on ED physician groups to dispute these underpayments, often to no avail.

Source DR. RINER

It was January 2009 when the California Supreme Court prohibited emergency physicians from balance billing the several million patients covered under that state's HMOs and Blue Cross and Blue Shield PPOs.

But now that the dust has settled, class action attorneys are moving in, both to file lawsuits against illegal balance billing that is still taking place and to have the state court's ruling applied retroactively.

For example, Derek Emge, a consumer class-action attorney in San Diego, said his firm is investigating two possible cases of balance billing that occurred after the Supreme Court's ruling. (No lawsuits have been filed.) His firm's Web site warns former emergency department patients that “a hospital or physician group may not bill or contact you about bills arising from emergency medical services. They may not threaten you with debt collection and/or ruining your credit. Any contact about your bill is prohibited” (www.emgelawfirm.com/CM/Custom/Illegal-charges-for-Emergency-Rooms.asp

But that's not really true, said Dr. R. Myles Riner, past president of CAL/ACEP. Ads like the one from Mr. Enge's firm seem to imply that all balance billing is illegal, that patients should never receive any bill from an emergency care provider, and that the Supreme Court decision applies to all insured patients, he said. In reality, by one estimate, the ruling applies to fewer than half of all commercially insured patients.

“But just the existence of these [ads] is likely to discourage patients from paying legitimate bills from emergency care providers that do not fall under the balance-billing prohibition,” such as coinsurance payments and deductibles, added Dr. Riner, director of provider relations for an emergency physician staffing and management company.

Andrew Selesnick, a health care attorney in Los Angeles, agreed. “You're putting out this false information, inaccurate information, and patients don't need much of an excuse not to pay the bill in the first place,” said Mr. Selesnick. “Now they can say, 'You were never allowed to send me a bill.'” Mr. Selesnick has been either lead or co-counsel for the defendants on just about all of the nearly half dozen lawsuits that have taken place so far. Mr. Emge said the Web page was simply intended to alert any patient who was billed for emergency department care that “there may be an issue.”

The essential question for lawsuits that do have standing will be whether the ruling may be applied retroactively, Mr. Selesnick said. Both attorneys agreed that, typically, these types of rulings are applied retroactively—and that could be very bad news for California emergency physician groups, said Mr. Selesnick. “If the court ordered the return of monies, it would be another blow to an already fragile safety net,” he said.

There are also privacy concerns. “How would the court presume to contact potential class members?” Mr. Selesnick asked. “Do they send a letter to the minor who went to the ED but never told her parents? Or do they send a letter to the husband who never informed his wife about a visit to the ED?”

Even if the balance-billing ruling is not given retroactive application, the damage may already be done to emergency care in California, Dr. Riner said. “The overall effect is to significantly increase the burden on ED physician groups to dispute these underpayments—often to no avail—and to adjust to the substantial decrease in revenues,” he added. That will happen by either cutting back on EP staffing, abandoning EDs with payer mixes that cannot support them, or seeking subsidies from hospitals.

“Longer term, the result will likely be longer waits for care in our EDs, poorer quality of care, closure of more EDs in poorer neighborhoods, and more frequent use of nonphysician practitioners to manage even the sickest patients in our EDs,” Dr. Riner said.

Read the full text of the January California Supreme Court ruling at www.calacep.org/spaw2/uploads/files/legal%20advocacy/Prospect_v_Northridge_Supreme_Court_Opinion.pdf

The effect is to increase the burden on ED physician groups to dispute these underpayments, often to no avail.

Source DR. RINER

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Low-Dose Doxycycline Sufficient in Rosacea

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Low-Dose Doxycycline Sufficient in Rosacea

The jury is still out on whether rosacea has a microbial etiology, but one thing is certain: Low-dose doxycycline is as effective as higher doses, with significantly fewer side effects, Dr. Guy Webster reported at a dermatology seminar sponsored by Skin Disease Education Foundation.

The microbial theory of rosacea's etiology has several problems, according to Dr. Webster of the department of dermatology at Jefferson Medical College in Philadelphia. In one small study, the bacterium Bacillus oleronius— extracted from mites found on the faces of rosacea patients—produced antigens that stimulated mononuclear cells in 16 of 22 rosacea patients (73%), ocompared with 5 of 17 controls (29%) (Brit. J. Derm. 2007;157:474-81). However, many patients didn't react, while some control patients did.

The theory that Helicobacter pylori might be related to rosacea has problems as well, Dr. Webster noted. One study of 44 patients found rosacea improved to the same degree in patients treated with placebo as with H. pylori eradication therapy (Arch. Dermatol. 1999;135:659-63).

Regardless of the cause, a low, 40-mg dose of doxycycline is sufficient treatment. In a study by CollaGenex Pharmaceuticals (now Galderma Laboratories), maker of 40-mg doxycycline (Oracea), a once-daily 40-mg dose led to a decrease of 12.5 lesions by 16 weeks, vs. a decrease of 12.2 lesions in the 100-mg doxycycline group, with fewer side effects.

Dr. Webster disclosed financial relationships with Galderma, Allergan, and GlaxoSmithKline.

SDEF and this news organization are owned by Elsevier.

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The jury is still out on whether rosacea has a microbial etiology, but one thing is certain: Low-dose doxycycline is as effective as higher doses, with significantly fewer side effects, Dr. Guy Webster reported at a dermatology seminar sponsored by Skin Disease Education Foundation.

The microbial theory of rosacea's etiology has several problems, according to Dr. Webster of the department of dermatology at Jefferson Medical College in Philadelphia. In one small study, the bacterium Bacillus oleronius— extracted from mites found on the faces of rosacea patients—produced antigens that stimulated mononuclear cells in 16 of 22 rosacea patients (73%), ocompared with 5 of 17 controls (29%) (Brit. J. Derm. 2007;157:474-81). However, many patients didn't react, while some control patients did.

The theory that Helicobacter pylori might be related to rosacea has problems as well, Dr. Webster noted. One study of 44 patients found rosacea improved to the same degree in patients treated with placebo as with H. pylori eradication therapy (Arch. Dermatol. 1999;135:659-63).

Regardless of the cause, a low, 40-mg dose of doxycycline is sufficient treatment. In a study by CollaGenex Pharmaceuticals (now Galderma Laboratories), maker of 40-mg doxycycline (Oracea), a once-daily 40-mg dose led to a decrease of 12.5 lesions by 16 weeks, vs. a decrease of 12.2 lesions in the 100-mg doxycycline group, with fewer side effects.

Dr. Webster disclosed financial relationships with Galderma, Allergan, and GlaxoSmithKline.

SDEF and this news organization are owned by Elsevier.

The jury is still out on whether rosacea has a microbial etiology, but one thing is certain: Low-dose doxycycline is as effective as higher doses, with significantly fewer side effects, Dr. Guy Webster reported at a dermatology seminar sponsored by Skin Disease Education Foundation.

The microbial theory of rosacea's etiology has several problems, according to Dr. Webster of the department of dermatology at Jefferson Medical College in Philadelphia. In one small study, the bacterium Bacillus oleronius— extracted from mites found on the faces of rosacea patients—produced antigens that stimulated mononuclear cells in 16 of 22 rosacea patients (73%), ocompared with 5 of 17 controls (29%) (Brit. J. Derm. 2007;157:474-81). However, many patients didn't react, while some control patients did.

The theory that Helicobacter pylori might be related to rosacea has problems as well, Dr. Webster noted. One study of 44 patients found rosacea improved to the same degree in patients treated with placebo as with H. pylori eradication therapy (Arch. Dermatol. 1999;135:659-63).

Regardless of the cause, a low, 40-mg dose of doxycycline is sufficient treatment. In a study by CollaGenex Pharmaceuticals (now Galderma Laboratories), maker of 40-mg doxycycline (Oracea), a once-daily 40-mg dose led to a decrease of 12.5 lesions by 16 weeks, vs. a decrease of 12.2 lesions in the 100-mg doxycycline group, with fewer side effects.

Dr. Webster disclosed financial relationships with Galderma, Allergan, and GlaxoSmithKline.

SDEF and this news organization are owned by Elsevier.

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