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Automated measurements of plasma predict amyloid status
, according to research published online ahead of print June 24 in JAMA Neurology. Analyzing APOE genotype in addition to these biomarkers increases the accuracy of the prediction. This blood test thus could allow neurologists to identify patients at risk of amyloid-beta positivity who should undergo further assessment, said the authors. It also could be used to enroll amyloid-beta–positive participants in clinical trials.
In vivo PET imaging and analysis of cerebrospinal fluid (CSF) can detect amyloid-beta, but these procedures are expensive, and their availability is limited. Clinicians need readily available methods for detecting amyloid-beta, and research has indicated that blood-based biomarkers correlate with those in CSF. Fully automated immunoassays, such as the Elecsys test developed by Roche Diagnostics, have recently demonstrated high reliability and precision for CSF amyloid-beta. Using the Elecsys assay, Sebastian Palmqvist, MD, PhD, a neurologist at Skåne University Hospital in Malmö, Sweden, and colleagues sought to examine the accuracy of plasma amyloid-beta and tau, together with other blood-based biomarkers, at detecting cerebral amyloid-beta.
Testing the immunoassay in two cohorts
Dr. Palmqvist and colleagues examined participants in the prospective Swedish BioFINDER Study, which enrolled patients between July 6, 2009, and February 11, 2015. This cohort included 513 cognitively unimpaired (CU) participants, 265 participants with mild cognitive impairment (MCI), and 64 participants with Alzheimer’s disease dementia. Investigators collected blood and CSF samples at the same time from all participants. Participants’ amyloid-beta status was ascertained using the Elecsys CSF amyloid-beta 42/amyloid-beta 40 ratio. The researchers defined amyloid-beta positivity with an unbiased cutoff of less than 0.059.
Dr. Palmqvist and colleagues also examined a validation cohort that included 237 participants who had been enrolled between January 29, 2000, and October 11, 2006, in Ulm and Hannover, Germany. This group included 34 CU participants, 109 participants with MCI, and 94 participants with mild Alzheimer’s disease dementia. The investigators applied the same cutoff of CSF amyloid-beta 42/amyloid-beta 40 to define amyloid-beta positivity in this cohort as they applied to the BioFINDER cohort.
Automated immunoassay had high predictive accuracy
The mean age of the BioFINDER cohort was 72 years, and 52.5% of participants were female. Overall, 44% of this cohort was amyloid-beta positive, including 29% of CU participants, 60% of participants with MCI, and 100% of participants with Alzheimer’s dementia. The investigators found statistically significant positive correlations between all plasma and corresponding CSF biomarkers in this cohort.
Plasma amyloid-beta 42 and amyloid-beta 40 levels predicted amyloid-beta status with an area under the receiver operating characteristic curve (AUC) of 0.80. When the researchers added APOE to the model, the AUC increased significantly to 0.85. Accuracy improved slightly when the researchers added plasma tau (AUC, 0.86) or tau and neurofilament light (AUC, 0.87) to amyloid-beta 42, amyloid-beta 40, and APOE. The results were similar in CU and cognitively impaired participants, and in younger and older participants.
In the validation cohort, the mean age was 66 years, and 50.6% of participants were female. When Dr. Palmqvist and colleagues applied the plasma amyloid-beta 42 and amyloid-beta 40 model from the BioFINDER cohort to this population, they obtained a slightly higher AUC (0.86), but plasma tau did not increase predictive accuracy.
The investigators performed a cost-benefit analysis using a scenario in which 1,000 amyloid-positive participants are included in a trial and given a cost of $4,000 per participant for amyloid PET. Using plasma amyloid-beta 42, amyloid-beta 40, and APOE in this scenario reduced PET costs by as much as 30%-50%, depending on the cutoff.
Validation cohort was small
Dr. Palmqvist and colleagues acknowledged that a lack of data about APOE was a limitation of their validation analysis. Other limitations that they acknowledged were the small population size, which precluded subpopulation analysis, and the lack of improvement in predictive ability when they replicated the model that included plasma tau.
“Overall, the accuracies of the amyloid-beta 42 and amyloid-beta 40 assays are not sufficient to be used on their own as a clinical test of amyloid-beta positivity,” said Dr. Palmqvist and colleagues. “Additional assay development is needed before this can be recommended, possibly together with other blood biomarkers and screening tools in diagnostic algorithms.”
Even though additional validation studies are necessary, the present findings indicate “the potential usefulness blood assays might have, especially considering the ongoing great need to recruit large cohorts for Alzheimer’s disease drug trials in preclinical and prodromal stages,” the authors concluded.
This investigation was funded by foundations including the European Research Council, the Swedish Research Council, and the Knut and Alice Wallenberg foundation. Several authors are employees of the Roche Group. One author served on a scientific advisory board for Roche Diagnostics, and another received institutional research support from that company.
SOURCE: Palmqvist S et al. JAMA Neurol. 2019 Jun 24. doi: 10.1001/jamaneurol.2019.1632.
The investigation by Palmqvist et al. “makes several significant advancements in the field,” said Sid E. O’Bryant, PhD, professor of pharmacology and neuroscience at the University of North Texas Health Science Center in Fort Worth, in an accompanying editorial. The study’s protocol design clears the ground for a context of use of a blood screen for amyloid positivity. Also, the fully automated immunoassay “yields performance measurements that are superior to [those of] many earlier nonautomated procedures,” said Dr. O’Bryant. When Dr. Palmqvist and colleagues applied their discovery findings from a training cohort directly to a test cohort, it produced strong results. “This study suggests that the field is one step closer to the actual application of blood-based biomarkers with specific contexts of use in Alzheimer’s disease.”
The main concern about the plasma biomarkers, however, is the scalability of the methods used to measure them. “If primary care physicians are to use such a technology, the technology must have the capacity to conduct hundreds of millions of assays annually around the globe,” said Dr. O’Bryant. “A blood test for primary care must fit into the existing protocols and parameters in clinical laboratory settings. The blood collection and processing procedures are not applicable to standard clinical lab practice and will cause substantial barriers to clinical application.”
In addition, the study authors emphasize the utility of the immunoassay for primary care, but the study was designed to test for amyloid positivity, which is more appropriate for clinical trials. “No currently available drugs for patient use target amyloid,” said Dr. O’Bryant. “Therefore, this specific context of use is geared more toward clinical trial application than primary care physicians who currently need a test for the presence or absence of Alzheimer’s disease so currently available treatments and support can be put in place for patients and family members.”
Nevertheless, Dr. Palmqvist and associates have presented promising data, Dr. O’Bryant continued. The question in the field is ceasing to be whether blood biomarkers can be used in Alzheimer’s disease, and becoming how they can be used.
The investigation by Palmqvist et al. “makes several significant advancements in the field,” said Sid E. O’Bryant, PhD, professor of pharmacology and neuroscience at the University of North Texas Health Science Center in Fort Worth, in an accompanying editorial. The study’s protocol design clears the ground for a context of use of a blood screen for amyloid positivity. Also, the fully automated immunoassay “yields performance measurements that are superior to [those of] many earlier nonautomated procedures,” said Dr. O’Bryant. When Dr. Palmqvist and colleagues applied their discovery findings from a training cohort directly to a test cohort, it produced strong results. “This study suggests that the field is one step closer to the actual application of blood-based biomarkers with specific contexts of use in Alzheimer’s disease.”
The main concern about the plasma biomarkers, however, is the scalability of the methods used to measure them. “If primary care physicians are to use such a technology, the technology must have the capacity to conduct hundreds of millions of assays annually around the globe,” said Dr. O’Bryant. “A blood test for primary care must fit into the existing protocols and parameters in clinical laboratory settings. The blood collection and processing procedures are not applicable to standard clinical lab practice and will cause substantial barriers to clinical application.”
In addition, the study authors emphasize the utility of the immunoassay for primary care, but the study was designed to test for amyloid positivity, which is more appropriate for clinical trials. “No currently available drugs for patient use target amyloid,” said Dr. O’Bryant. “Therefore, this specific context of use is geared more toward clinical trial application than primary care physicians who currently need a test for the presence or absence of Alzheimer’s disease so currently available treatments and support can be put in place for patients and family members.”
Nevertheless, Dr. Palmqvist and associates have presented promising data, Dr. O’Bryant continued. The question in the field is ceasing to be whether blood biomarkers can be used in Alzheimer’s disease, and becoming how they can be used.
The investigation by Palmqvist et al. “makes several significant advancements in the field,” said Sid E. O’Bryant, PhD, professor of pharmacology and neuroscience at the University of North Texas Health Science Center in Fort Worth, in an accompanying editorial. The study’s protocol design clears the ground for a context of use of a blood screen for amyloid positivity. Also, the fully automated immunoassay “yields performance measurements that are superior to [those of] many earlier nonautomated procedures,” said Dr. O’Bryant. When Dr. Palmqvist and colleagues applied their discovery findings from a training cohort directly to a test cohort, it produced strong results. “This study suggests that the field is one step closer to the actual application of blood-based biomarkers with specific contexts of use in Alzheimer’s disease.”
The main concern about the plasma biomarkers, however, is the scalability of the methods used to measure them. “If primary care physicians are to use such a technology, the technology must have the capacity to conduct hundreds of millions of assays annually around the globe,” said Dr. O’Bryant. “A blood test for primary care must fit into the existing protocols and parameters in clinical laboratory settings. The blood collection and processing procedures are not applicable to standard clinical lab practice and will cause substantial barriers to clinical application.”
In addition, the study authors emphasize the utility of the immunoassay for primary care, but the study was designed to test for amyloid positivity, which is more appropriate for clinical trials. “No currently available drugs for patient use target amyloid,” said Dr. O’Bryant. “Therefore, this specific context of use is geared more toward clinical trial application than primary care physicians who currently need a test for the presence or absence of Alzheimer’s disease so currently available treatments and support can be put in place for patients and family members.”
Nevertheless, Dr. Palmqvist and associates have presented promising data, Dr. O’Bryant continued. The question in the field is ceasing to be whether blood biomarkers can be used in Alzheimer’s disease, and becoming how they can be used.
, according to research published online ahead of print June 24 in JAMA Neurology. Analyzing APOE genotype in addition to these biomarkers increases the accuracy of the prediction. This blood test thus could allow neurologists to identify patients at risk of amyloid-beta positivity who should undergo further assessment, said the authors. It also could be used to enroll amyloid-beta–positive participants in clinical trials.
In vivo PET imaging and analysis of cerebrospinal fluid (CSF) can detect amyloid-beta, but these procedures are expensive, and their availability is limited. Clinicians need readily available methods for detecting amyloid-beta, and research has indicated that blood-based biomarkers correlate with those in CSF. Fully automated immunoassays, such as the Elecsys test developed by Roche Diagnostics, have recently demonstrated high reliability and precision for CSF amyloid-beta. Using the Elecsys assay, Sebastian Palmqvist, MD, PhD, a neurologist at Skåne University Hospital in Malmö, Sweden, and colleagues sought to examine the accuracy of plasma amyloid-beta and tau, together with other blood-based biomarkers, at detecting cerebral amyloid-beta.
Testing the immunoassay in two cohorts
Dr. Palmqvist and colleagues examined participants in the prospective Swedish BioFINDER Study, which enrolled patients between July 6, 2009, and February 11, 2015. This cohort included 513 cognitively unimpaired (CU) participants, 265 participants with mild cognitive impairment (MCI), and 64 participants with Alzheimer’s disease dementia. Investigators collected blood and CSF samples at the same time from all participants. Participants’ amyloid-beta status was ascertained using the Elecsys CSF amyloid-beta 42/amyloid-beta 40 ratio. The researchers defined amyloid-beta positivity with an unbiased cutoff of less than 0.059.
Dr. Palmqvist and colleagues also examined a validation cohort that included 237 participants who had been enrolled between January 29, 2000, and October 11, 2006, in Ulm and Hannover, Germany. This group included 34 CU participants, 109 participants with MCI, and 94 participants with mild Alzheimer’s disease dementia. The investigators applied the same cutoff of CSF amyloid-beta 42/amyloid-beta 40 to define amyloid-beta positivity in this cohort as they applied to the BioFINDER cohort.
Automated immunoassay had high predictive accuracy
The mean age of the BioFINDER cohort was 72 years, and 52.5% of participants were female. Overall, 44% of this cohort was amyloid-beta positive, including 29% of CU participants, 60% of participants with MCI, and 100% of participants with Alzheimer’s dementia. The investigators found statistically significant positive correlations between all plasma and corresponding CSF biomarkers in this cohort.
Plasma amyloid-beta 42 and amyloid-beta 40 levels predicted amyloid-beta status with an area under the receiver operating characteristic curve (AUC) of 0.80. When the researchers added APOE to the model, the AUC increased significantly to 0.85. Accuracy improved slightly when the researchers added plasma tau (AUC, 0.86) or tau and neurofilament light (AUC, 0.87) to amyloid-beta 42, amyloid-beta 40, and APOE. The results were similar in CU and cognitively impaired participants, and in younger and older participants.
In the validation cohort, the mean age was 66 years, and 50.6% of participants were female. When Dr. Palmqvist and colleagues applied the plasma amyloid-beta 42 and amyloid-beta 40 model from the BioFINDER cohort to this population, they obtained a slightly higher AUC (0.86), but plasma tau did not increase predictive accuracy.
The investigators performed a cost-benefit analysis using a scenario in which 1,000 amyloid-positive participants are included in a trial and given a cost of $4,000 per participant for amyloid PET. Using plasma amyloid-beta 42, amyloid-beta 40, and APOE in this scenario reduced PET costs by as much as 30%-50%, depending on the cutoff.
Validation cohort was small
Dr. Palmqvist and colleagues acknowledged that a lack of data about APOE was a limitation of their validation analysis. Other limitations that they acknowledged were the small population size, which precluded subpopulation analysis, and the lack of improvement in predictive ability when they replicated the model that included plasma tau.
“Overall, the accuracies of the amyloid-beta 42 and amyloid-beta 40 assays are not sufficient to be used on their own as a clinical test of amyloid-beta positivity,” said Dr. Palmqvist and colleagues. “Additional assay development is needed before this can be recommended, possibly together with other blood biomarkers and screening tools in diagnostic algorithms.”
Even though additional validation studies are necessary, the present findings indicate “the potential usefulness blood assays might have, especially considering the ongoing great need to recruit large cohorts for Alzheimer’s disease drug trials in preclinical and prodromal stages,” the authors concluded.
This investigation was funded by foundations including the European Research Council, the Swedish Research Council, and the Knut and Alice Wallenberg foundation. Several authors are employees of the Roche Group. One author served on a scientific advisory board for Roche Diagnostics, and another received institutional research support from that company.
SOURCE: Palmqvist S et al. JAMA Neurol. 2019 Jun 24. doi: 10.1001/jamaneurol.2019.1632.
, according to research published online ahead of print June 24 in JAMA Neurology. Analyzing APOE genotype in addition to these biomarkers increases the accuracy of the prediction. This blood test thus could allow neurologists to identify patients at risk of amyloid-beta positivity who should undergo further assessment, said the authors. It also could be used to enroll amyloid-beta–positive participants in clinical trials.
In vivo PET imaging and analysis of cerebrospinal fluid (CSF) can detect amyloid-beta, but these procedures are expensive, and their availability is limited. Clinicians need readily available methods for detecting amyloid-beta, and research has indicated that blood-based biomarkers correlate with those in CSF. Fully automated immunoassays, such as the Elecsys test developed by Roche Diagnostics, have recently demonstrated high reliability and precision for CSF amyloid-beta. Using the Elecsys assay, Sebastian Palmqvist, MD, PhD, a neurologist at Skåne University Hospital in Malmö, Sweden, and colleagues sought to examine the accuracy of plasma amyloid-beta and tau, together with other blood-based biomarkers, at detecting cerebral amyloid-beta.
Testing the immunoassay in two cohorts
Dr. Palmqvist and colleagues examined participants in the prospective Swedish BioFINDER Study, which enrolled patients between July 6, 2009, and February 11, 2015. This cohort included 513 cognitively unimpaired (CU) participants, 265 participants with mild cognitive impairment (MCI), and 64 participants with Alzheimer’s disease dementia. Investigators collected blood and CSF samples at the same time from all participants. Participants’ amyloid-beta status was ascertained using the Elecsys CSF amyloid-beta 42/amyloid-beta 40 ratio. The researchers defined amyloid-beta positivity with an unbiased cutoff of less than 0.059.
Dr. Palmqvist and colleagues also examined a validation cohort that included 237 participants who had been enrolled between January 29, 2000, and October 11, 2006, in Ulm and Hannover, Germany. This group included 34 CU participants, 109 participants with MCI, and 94 participants with mild Alzheimer’s disease dementia. The investigators applied the same cutoff of CSF amyloid-beta 42/amyloid-beta 40 to define amyloid-beta positivity in this cohort as they applied to the BioFINDER cohort.
Automated immunoassay had high predictive accuracy
The mean age of the BioFINDER cohort was 72 years, and 52.5% of participants were female. Overall, 44% of this cohort was amyloid-beta positive, including 29% of CU participants, 60% of participants with MCI, and 100% of participants with Alzheimer’s dementia. The investigators found statistically significant positive correlations between all plasma and corresponding CSF biomarkers in this cohort.
Plasma amyloid-beta 42 and amyloid-beta 40 levels predicted amyloid-beta status with an area under the receiver operating characteristic curve (AUC) of 0.80. When the researchers added APOE to the model, the AUC increased significantly to 0.85. Accuracy improved slightly when the researchers added plasma tau (AUC, 0.86) or tau and neurofilament light (AUC, 0.87) to amyloid-beta 42, amyloid-beta 40, and APOE. The results were similar in CU and cognitively impaired participants, and in younger and older participants.
In the validation cohort, the mean age was 66 years, and 50.6% of participants were female. When Dr. Palmqvist and colleagues applied the plasma amyloid-beta 42 and amyloid-beta 40 model from the BioFINDER cohort to this population, they obtained a slightly higher AUC (0.86), but plasma tau did not increase predictive accuracy.
The investigators performed a cost-benefit analysis using a scenario in which 1,000 amyloid-positive participants are included in a trial and given a cost of $4,000 per participant for amyloid PET. Using plasma amyloid-beta 42, amyloid-beta 40, and APOE in this scenario reduced PET costs by as much as 30%-50%, depending on the cutoff.
Validation cohort was small
Dr. Palmqvist and colleagues acknowledged that a lack of data about APOE was a limitation of their validation analysis. Other limitations that they acknowledged were the small population size, which precluded subpopulation analysis, and the lack of improvement in predictive ability when they replicated the model that included plasma tau.
“Overall, the accuracies of the amyloid-beta 42 and amyloid-beta 40 assays are not sufficient to be used on their own as a clinical test of amyloid-beta positivity,” said Dr. Palmqvist and colleagues. “Additional assay development is needed before this can be recommended, possibly together with other blood biomarkers and screening tools in diagnostic algorithms.”
Even though additional validation studies are necessary, the present findings indicate “the potential usefulness blood assays might have, especially considering the ongoing great need to recruit large cohorts for Alzheimer’s disease drug trials in preclinical and prodromal stages,” the authors concluded.
This investigation was funded by foundations including the European Research Council, the Swedish Research Council, and the Knut and Alice Wallenberg foundation. Several authors are employees of the Roche Group. One author served on a scientific advisory board for Roche Diagnostics, and another received institutional research support from that company.
SOURCE: Palmqvist S et al. JAMA Neurol. 2019 Jun 24. doi: 10.1001/jamaneurol.2019.1632.
FROM JAMA NEUROLOGY
FDA approves first treatment for neuromyelitis optica spectrum disorder
Soliris, a complement inhibitor, is the first FDA-approved treatment for NMOSD, a rare autoimmune disease of the central nervous system that mainly affects the optic nerves and spinal cord, according to a news release.
About 73% of patients with NMOSD test positive for anti-AQP4 antibodies, and complement activation resulting from anti-AQP4 antibodies is an underlying cause of the disease, according to the news release from Alexion, the company that markets the drug. The average age of NMOSD onset is 39 years, and the disease can lead to permanent visual impairment and paralysis. The condition, previously known as Devic’s disease, may affect between 4,000 and 8,000 people in the United States. NMOSD may be confused with other neurologic conditions such as multiple sclerosis.
Investigators studied the drug’s effectiveness in a placebo-controlled clinical trial of 143 patients with NMOSD who had anti-AQP4 antibodies. Compared with placebo, Soliris reduced the number of NMOSD relapses by 94% during the 48-week study. Nearly 98% of patients in the PREVENT trial who received Soliris were relapse-free after 48 weeks, compared with 63% of patients who received placebo.
Soliris also reduced hospitalizations and the need for corticosteroids and plasma exchange to treat acute attacks.
Soliris includes a boxed warning about life-threatening and fatal meningococcal infections that have occurred in patients treated with Soliris. Patients should be monitored and evaluated immediately if infection is suspected, according to the FDA announcement. In addition, health care professionals should use caution when administering Soliris to patients with any other infection. No cases of meningococcal infection were observed in the PREVENT trial.
Soliris is available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Prescribers must counsel patients about the risk of meningococcal infection and ensure that patients have been vaccinated with meningococcal vaccines.
Adverse reactions in the NMOSD clinical trial included upper respiratory infection, nasopharyngitis, diarrhea, back pain, dizziness, influenza, joint pain, sore throat, and confusion.
The drug’s use for NMOSD received Orphan Drug designation, which provides incentives for the development of drugs for rare diseases.
Eculizumab first was approved by the FDA in 2007 and also may be used to treat paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic syndrome, and myasthenia gravis.
Soliris, a complement inhibitor, is the first FDA-approved treatment for NMOSD, a rare autoimmune disease of the central nervous system that mainly affects the optic nerves and spinal cord, according to a news release.
About 73% of patients with NMOSD test positive for anti-AQP4 antibodies, and complement activation resulting from anti-AQP4 antibodies is an underlying cause of the disease, according to the news release from Alexion, the company that markets the drug. The average age of NMOSD onset is 39 years, and the disease can lead to permanent visual impairment and paralysis. The condition, previously known as Devic’s disease, may affect between 4,000 and 8,000 people in the United States. NMOSD may be confused with other neurologic conditions such as multiple sclerosis.
Investigators studied the drug’s effectiveness in a placebo-controlled clinical trial of 143 patients with NMOSD who had anti-AQP4 antibodies. Compared with placebo, Soliris reduced the number of NMOSD relapses by 94% during the 48-week study. Nearly 98% of patients in the PREVENT trial who received Soliris were relapse-free after 48 weeks, compared with 63% of patients who received placebo.
Soliris also reduced hospitalizations and the need for corticosteroids and plasma exchange to treat acute attacks.
Soliris includes a boxed warning about life-threatening and fatal meningococcal infections that have occurred in patients treated with Soliris. Patients should be monitored and evaluated immediately if infection is suspected, according to the FDA announcement. In addition, health care professionals should use caution when administering Soliris to patients with any other infection. No cases of meningococcal infection were observed in the PREVENT trial.
Soliris is available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Prescribers must counsel patients about the risk of meningococcal infection and ensure that patients have been vaccinated with meningococcal vaccines.
Adverse reactions in the NMOSD clinical trial included upper respiratory infection, nasopharyngitis, diarrhea, back pain, dizziness, influenza, joint pain, sore throat, and confusion.
The drug’s use for NMOSD received Orphan Drug designation, which provides incentives for the development of drugs for rare diseases.
Eculizumab first was approved by the FDA in 2007 and also may be used to treat paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic syndrome, and myasthenia gravis.
Soliris, a complement inhibitor, is the first FDA-approved treatment for NMOSD, a rare autoimmune disease of the central nervous system that mainly affects the optic nerves and spinal cord, according to a news release.
About 73% of patients with NMOSD test positive for anti-AQP4 antibodies, and complement activation resulting from anti-AQP4 antibodies is an underlying cause of the disease, according to the news release from Alexion, the company that markets the drug. The average age of NMOSD onset is 39 years, and the disease can lead to permanent visual impairment and paralysis. The condition, previously known as Devic’s disease, may affect between 4,000 and 8,000 people in the United States. NMOSD may be confused with other neurologic conditions such as multiple sclerosis.
Investigators studied the drug’s effectiveness in a placebo-controlled clinical trial of 143 patients with NMOSD who had anti-AQP4 antibodies. Compared with placebo, Soliris reduced the number of NMOSD relapses by 94% during the 48-week study. Nearly 98% of patients in the PREVENT trial who received Soliris were relapse-free after 48 weeks, compared with 63% of patients who received placebo.
Soliris also reduced hospitalizations and the need for corticosteroids and plasma exchange to treat acute attacks.
Soliris includes a boxed warning about life-threatening and fatal meningococcal infections that have occurred in patients treated with Soliris. Patients should be monitored and evaluated immediately if infection is suspected, according to the FDA announcement. In addition, health care professionals should use caution when administering Soliris to patients with any other infection. No cases of meningococcal infection were observed in the PREVENT trial.
Soliris is available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Prescribers must counsel patients about the risk of meningococcal infection and ensure that patients have been vaccinated with meningococcal vaccines.
Adverse reactions in the NMOSD clinical trial included upper respiratory infection, nasopharyngitis, diarrhea, back pain, dizziness, influenza, joint pain, sore throat, and confusion.
The drug’s use for NMOSD received Orphan Drug designation, which provides incentives for the development of drugs for rare diseases.
Eculizumab first was approved by the FDA in 2007 and also may be used to treat paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic syndrome, and myasthenia gravis.
‘Medicare for All’ emerges as early divide in first Democratic debate
Health care dominated early on June 26, with Sens. Elizabeth Warren (Mass.) and Cory Booker (N.J.) using questions about the economy to take aim at pharmaceutical and insurance companies. Sen. Amy Klobuchar (Minn.) emphasized the difficulties many Americans face in paying premiums.
But the candidates broke ranks on the details and not all of their claims stayed strictly within the lines.
Only two candidates — New York City Mayor Bill de Blasio and Sen. Warren — raised their hands in favor of banishing private insurance to install a government-sponsored Medicare for All approach.
Sen. Klobuchar, a single-payer skeptic, expressed concern about “kicking half of America off their health insurance in 4 years.” (That’s correct: In 2017, a majority of Americans had private coverage, with 49% getting that insurance through work, according to the Kaiser Family Foundation.)
Former Texas Rep. Beto O’Rourke, who also supports maintaining a private insurance system, outlined his own universal health care plan, based on a “Medicare for America” bill in Congress.
The single-payer talk set off other discussions about the role of health insurance and the cost of care. We fact-checked some of the biggest claims.
Sen. Warren: “The insurance companies last year alone sucked $23 billion in profits out of the health care system. $23 billion. And that doesn’t count the money that was paid to executives, the money that was spent lobbying Washington.”
We contacted Warren’s campaign, who directed us to a report from the National Association of Insurance Commissioners, a nonpartisan group of industry regulators. It supports her assessment.
The report says that in 2018, health insurers posted $23.4 billion in net earnings, or profits, compared with $16.1 billion a year prior.
This came up in the context of Warren’s support for eliminating private insurance under a Medicare for All system. However, the financing and price tag of such a system is unclear.
Sen. Booker: “The overhead for insurers that they charge is 15%, while Medicare’s overhead is only at 2%.”
This is a flawed comparison. Booker said administrative overhead eats up much more for private carriers than it does for Medicare, the government insurance program for seniors and the disabled. But Medicare piggybacks off the Social Security Administration, which covers costs of enrollment, payments, and keeping track of patients.
Also, Medicare relies on private providers for some of its programs, and overhead charges there are higher. Medicare’s overhead is less than that of private carriers, but exact figures are elusive.
The insurance companies’ trade group, America’s Health Insurance Plans (AHIP), reported in 2018 that 18.1% of private health care premiums went to non–health care services. That includes taxes of 4.7% and profits of 2.3%. The Medicare trustees reported that in 2018, total expenses were $740.6 billion, with administrative expenses of $9.9 billion. That comes to 1.3%, less than Booker said.
Sen. Warren: “I spent a big chunk of my life studying why families go broke, and one of the No. 1 reasons is the cost of health care, medical bills. And that’s not just for people who don’t have insurance. It’s for people who have insurance.”
Is the No. 1 reason people go broke the cost of health care? We’ve rated similar statements Half True — partially accurate but lacking important context.
A 2005 study Warren coauthored and a 2009 paper both found that health care expenses were a leading cause of personal bankruptcy. But these claims have come under dispute, in particular from academics who suggest that people may overstate the role medical bills play in their financial problems. Other research suggests a far narrower impact, though that, in turn, has been criticized for focusing only on adult hospitalizations.
That said, research from the Consumer Financial Protection Bureau found that medical bills are a leading cause of personal debt — in 2014, the CFPB found that nearly 20% of credit reports included a medical debt tradeline.
But Rep. Tulsi Gabbard (Hawaii) drew on examples of universal health coverage in other countries to explain why she still supported some private insurance options.
Rep. Gabbard: “If you look at other countries in the world who have universal health care, every one of them has some form of a role of private insurance.”
This is correct. Virtually every country with universal health care includes a role for private insurance. Some allow it to cover services not addressed by the national plan. Others allow it as a means to get care faster. Others heavily regulate it as a principal source of coverage.
For instance, Canada, the model for the principal Medicare for All bill, allows private insurance to address prescription drug coverage, private rooms in hospitals, and vision and dental care. (It is not allowed to compete with the government plan.) In England, about 10% of people — mostly wealthier people — elect for private coverage, which can yield faster access to care. Countries such as the Netherlands and Switzerland heavily regulate private coverage.
Beyond Medicare for All, candidates touched on strategies to bring down drug prices as well as other issues.
Sen. Klobuchar: “2,500 drug prices have gone up in double digits since [Donald Trump] took office.”
This is accurate, according to a report from Pharmacy Benefits Consultants, an industry group, which listed a number of pharmaceutical products experiencing price increases as high as 1,468%.
And the numbers are even less flattering than Sen. Klobuchar suggested.
An analysis by the Associated Press found that, between January and July 2018, more than 4,400 branded prescription drugs experienced price increases. Meanwhile, data compiled by Rx Savings Solutions found that the list price of more than 3,000 drugs went up this year.
Rep. O’Rourke: “In Texas, the single largest provider of mental health care is the county jail system.”
This is correct. Texas jails are the largest mental health care systems in the state, according to a report from the University of Texas at Austin. The Harris County jail, which includes a 108-bed unit, identifies itself as the largest mental health care facility in Texas.
This is not a Texas-specific issue. According to a 2011 NPR report, it is more common to see Americans getting mental health care in jails and prisons than in hospitals or other dedicated treatment facilities.
Election Day is 495 days away.
Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente. Politifact is owned by the nonprofit Poynter Institute for Media Studies.
Health care dominated early on June 26, with Sens. Elizabeth Warren (Mass.) and Cory Booker (N.J.) using questions about the economy to take aim at pharmaceutical and insurance companies. Sen. Amy Klobuchar (Minn.) emphasized the difficulties many Americans face in paying premiums.
But the candidates broke ranks on the details and not all of their claims stayed strictly within the lines.
Only two candidates — New York City Mayor Bill de Blasio and Sen. Warren — raised their hands in favor of banishing private insurance to install a government-sponsored Medicare for All approach.
Sen. Klobuchar, a single-payer skeptic, expressed concern about “kicking half of America off their health insurance in 4 years.” (That’s correct: In 2017, a majority of Americans had private coverage, with 49% getting that insurance through work, according to the Kaiser Family Foundation.)
Former Texas Rep. Beto O’Rourke, who also supports maintaining a private insurance system, outlined his own universal health care plan, based on a “Medicare for America” bill in Congress.
The single-payer talk set off other discussions about the role of health insurance and the cost of care. We fact-checked some of the biggest claims.
Sen. Warren: “The insurance companies last year alone sucked $23 billion in profits out of the health care system. $23 billion. And that doesn’t count the money that was paid to executives, the money that was spent lobbying Washington.”
We contacted Warren’s campaign, who directed us to a report from the National Association of Insurance Commissioners, a nonpartisan group of industry regulators. It supports her assessment.
The report says that in 2018, health insurers posted $23.4 billion in net earnings, or profits, compared with $16.1 billion a year prior.
This came up in the context of Warren’s support for eliminating private insurance under a Medicare for All system. However, the financing and price tag of such a system is unclear.
Sen. Booker: “The overhead for insurers that they charge is 15%, while Medicare’s overhead is only at 2%.”
This is a flawed comparison. Booker said administrative overhead eats up much more for private carriers than it does for Medicare, the government insurance program for seniors and the disabled. But Medicare piggybacks off the Social Security Administration, which covers costs of enrollment, payments, and keeping track of patients.
Also, Medicare relies on private providers for some of its programs, and overhead charges there are higher. Medicare’s overhead is less than that of private carriers, but exact figures are elusive.
The insurance companies’ trade group, America’s Health Insurance Plans (AHIP), reported in 2018 that 18.1% of private health care premiums went to non–health care services. That includes taxes of 4.7% and profits of 2.3%. The Medicare trustees reported that in 2018, total expenses were $740.6 billion, with administrative expenses of $9.9 billion. That comes to 1.3%, less than Booker said.
Sen. Warren: “I spent a big chunk of my life studying why families go broke, and one of the No. 1 reasons is the cost of health care, medical bills. And that’s not just for people who don’t have insurance. It’s for people who have insurance.”
Is the No. 1 reason people go broke the cost of health care? We’ve rated similar statements Half True — partially accurate but lacking important context.
A 2005 study Warren coauthored and a 2009 paper both found that health care expenses were a leading cause of personal bankruptcy. But these claims have come under dispute, in particular from academics who suggest that people may overstate the role medical bills play in their financial problems. Other research suggests a far narrower impact, though that, in turn, has been criticized for focusing only on adult hospitalizations.
That said, research from the Consumer Financial Protection Bureau found that medical bills are a leading cause of personal debt — in 2014, the CFPB found that nearly 20% of credit reports included a medical debt tradeline.
But Rep. Tulsi Gabbard (Hawaii) drew on examples of universal health coverage in other countries to explain why she still supported some private insurance options.
Rep. Gabbard: “If you look at other countries in the world who have universal health care, every one of them has some form of a role of private insurance.”
This is correct. Virtually every country with universal health care includes a role for private insurance. Some allow it to cover services not addressed by the national plan. Others allow it as a means to get care faster. Others heavily regulate it as a principal source of coverage.
For instance, Canada, the model for the principal Medicare for All bill, allows private insurance to address prescription drug coverage, private rooms in hospitals, and vision and dental care. (It is not allowed to compete with the government plan.) In England, about 10% of people — mostly wealthier people — elect for private coverage, which can yield faster access to care. Countries such as the Netherlands and Switzerland heavily regulate private coverage.
Beyond Medicare for All, candidates touched on strategies to bring down drug prices as well as other issues.
Sen. Klobuchar: “2,500 drug prices have gone up in double digits since [Donald Trump] took office.”
This is accurate, according to a report from Pharmacy Benefits Consultants, an industry group, which listed a number of pharmaceutical products experiencing price increases as high as 1,468%.
And the numbers are even less flattering than Sen. Klobuchar suggested.
An analysis by the Associated Press found that, between January and July 2018, more than 4,400 branded prescription drugs experienced price increases. Meanwhile, data compiled by Rx Savings Solutions found that the list price of more than 3,000 drugs went up this year.
Rep. O’Rourke: “In Texas, the single largest provider of mental health care is the county jail system.”
This is correct. Texas jails are the largest mental health care systems in the state, according to a report from the University of Texas at Austin. The Harris County jail, which includes a 108-bed unit, identifies itself as the largest mental health care facility in Texas.
This is not a Texas-specific issue. According to a 2011 NPR report, it is more common to see Americans getting mental health care in jails and prisons than in hospitals or other dedicated treatment facilities.
Election Day is 495 days away.
Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente. Politifact is owned by the nonprofit Poynter Institute for Media Studies.
Health care dominated early on June 26, with Sens. Elizabeth Warren (Mass.) and Cory Booker (N.J.) using questions about the economy to take aim at pharmaceutical and insurance companies. Sen. Amy Klobuchar (Minn.) emphasized the difficulties many Americans face in paying premiums.
But the candidates broke ranks on the details and not all of their claims stayed strictly within the lines.
Only two candidates — New York City Mayor Bill de Blasio and Sen. Warren — raised their hands in favor of banishing private insurance to install a government-sponsored Medicare for All approach.
Sen. Klobuchar, a single-payer skeptic, expressed concern about “kicking half of America off their health insurance in 4 years.” (That’s correct: In 2017, a majority of Americans had private coverage, with 49% getting that insurance through work, according to the Kaiser Family Foundation.)
Former Texas Rep. Beto O’Rourke, who also supports maintaining a private insurance system, outlined his own universal health care plan, based on a “Medicare for America” bill in Congress.
The single-payer talk set off other discussions about the role of health insurance and the cost of care. We fact-checked some of the biggest claims.
Sen. Warren: “The insurance companies last year alone sucked $23 billion in profits out of the health care system. $23 billion. And that doesn’t count the money that was paid to executives, the money that was spent lobbying Washington.”
We contacted Warren’s campaign, who directed us to a report from the National Association of Insurance Commissioners, a nonpartisan group of industry regulators. It supports her assessment.
The report says that in 2018, health insurers posted $23.4 billion in net earnings, or profits, compared with $16.1 billion a year prior.
This came up in the context of Warren’s support for eliminating private insurance under a Medicare for All system. However, the financing and price tag of such a system is unclear.
Sen. Booker: “The overhead for insurers that they charge is 15%, while Medicare’s overhead is only at 2%.”
This is a flawed comparison. Booker said administrative overhead eats up much more for private carriers than it does for Medicare, the government insurance program for seniors and the disabled. But Medicare piggybacks off the Social Security Administration, which covers costs of enrollment, payments, and keeping track of patients.
Also, Medicare relies on private providers for some of its programs, and overhead charges there are higher. Medicare’s overhead is less than that of private carriers, but exact figures are elusive.
The insurance companies’ trade group, America’s Health Insurance Plans (AHIP), reported in 2018 that 18.1% of private health care premiums went to non–health care services. That includes taxes of 4.7% and profits of 2.3%. The Medicare trustees reported that in 2018, total expenses were $740.6 billion, with administrative expenses of $9.9 billion. That comes to 1.3%, less than Booker said.
Sen. Warren: “I spent a big chunk of my life studying why families go broke, and one of the No. 1 reasons is the cost of health care, medical bills. And that’s not just for people who don’t have insurance. It’s for people who have insurance.”
Is the No. 1 reason people go broke the cost of health care? We’ve rated similar statements Half True — partially accurate but lacking important context.
A 2005 study Warren coauthored and a 2009 paper both found that health care expenses were a leading cause of personal bankruptcy. But these claims have come under dispute, in particular from academics who suggest that people may overstate the role medical bills play in their financial problems. Other research suggests a far narrower impact, though that, in turn, has been criticized for focusing only on adult hospitalizations.
That said, research from the Consumer Financial Protection Bureau found that medical bills are a leading cause of personal debt — in 2014, the CFPB found that nearly 20% of credit reports included a medical debt tradeline.
But Rep. Tulsi Gabbard (Hawaii) drew on examples of universal health coverage in other countries to explain why she still supported some private insurance options.
Rep. Gabbard: “If you look at other countries in the world who have universal health care, every one of them has some form of a role of private insurance.”
This is correct. Virtually every country with universal health care includes a role for private insurance. Some allow it to cover services not addressed by the national plan. Others allow it as a means to get care faster. Others heavily regulate it as a principal source of coverage.
For instance, Canada, the model for the principal Medicare for All bill, allows private insurance to address prescription drug coverage, private rooms in hospitals, and vision and dental care. (It is not allowed to compete with the government plan.) In England, about 10% of people — mostly wealthier people — elect for private coverage, which can yield faster access to care. Countries such as the Netherlands and Switzerland heavily regulate private coverage.
Beyond Medicare for All, candidates touched on strategies to bring down drug prices as well as other issues.
Sen. Klobuchar: “2,500 drug prices have gone up in double digits since [Donald Trump] took office.”
This is accurate, according to a report from Pharmacy Benefits Consultants, an industry group, which listed a number of pharmaceutical products experiencing price increases as high as 1,468%.
And the numbers are even less flattering than Sen. Klobuchar suggested.
An analysis by the Associated Press found that, between January and July 2018, more than 4,400 branded prescription drugs experienced price increases. Meanwhile, data compiled by Rx Savings Solutions found that the list price of more than 3,000 drugs went up this year.
Rep. O’Rourke: “In Texas, the single largest provider of mental health care is the county jail system.”
This is correct. Texas jails are the largest mental health care systems in the state, according to a report from the University of Texas at Austin. The Harris County jail, which includes a 108-bed unit, identifies itself as the largest mental health care facility in Texas.
This is not a Texas-specific issue. According to a 2011 NPR report, it is more common to see Americans getting mental health care in jails and prisons than in hospitals or other dedicated treatment facilities.
Election Day is 495 days away.
Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente. Politifact is owned by the nonprofit Poynter Institute for Media Studies.
Surprise billing legislation passes Senate committee
A bill aimed at ending the practice of surprise billing, along with a number of other health care cost-containment measures, passed by an overwhelming majority during a mark-up session of the Senate Health, Education, Labor, and Pensions Committee.
S. 1895, the Lower Health Care Costs Act of 2019, passed 20-3; Sens. Rand Paul (R-Ky.), Bernie Sanders (D-Ver.) and Elizabeth Warren (D-Mass.) voted against it.
A summary of the bill’s provisions can be found here.
With Sen. Sanders and Sen. Warren not present, presumably out to prepare for the Democratic presidential nominee debates and voting by proxy, only Sen. Paul was present to speak against the bill. He questioned whether it would have any impact on lowering health care cost.
Among other provisions, the bill would ban all gag clauses that would keep pricing data from being released; all anticompetitive clauses in facility and insurance contracts that would otherwise limit access to higher-quality, lower-cost care; would designate a nongovernment entity focused on price transparency; and would improve the accuracy of directory information.
But government-induced transparency is not the solution, Sen. Paul said.
He called it a “fallacy” that “you can mandate transparency, and you’ll create a marketplace.” Rather, you need to create a marketplace, and transparency will naturally follow, he said.
Sen. Paul noted that just having institutions publishing prices that no one pays and prices that are not freely fluctuating “doesn’t work.”
“The irony here is that, when you have no insurance involved, you actually have a marketplace,” he said. “The people without insurance are the only true marketplace,” he said, adding that those with high deductibles would also fall into that category.
The crux of S. 1895 is protections to end so-called “surprise bills” that occur when patients receive medical services from out-of-network health care professionals at in-network hospitals. These out-of-network services are not constrained by prior agreements and can add up to tens of thousands of dollars.
“There are those who have seen the history of price controls and know that you never get what you intended,” he said, and predicted that this could lead to a shortage of physicians.
The American Medical Association also criticized the surprise billing provisions of the bill.
In a June 25 letter, the AMA noted that “the approach outlined in S. 1895 fails to address some of the fundamental reasons why surprise billing occurs – inadequate provider networks, higher patient-cost sharing requirements for out-of-network services, and noncompetitive local markets that empower plans to offer take-it-or-leave-it contracts.”
AMA also criticized the use of benchmark pricing to settle out-of-network billing issues. “By setting a payment maximum at the individual plans’ median in-network amount, insurers will have even less incentive to negotiate contracts with individual providers,” according to the letter. “They can drive down the median in-network amount by simply dropping from their networks providers who are currently paid above the median. Or, they can simply stop negotiating altogether, knowing that their financial obligation is limited to their own median in-network payment amounts.”
The Physicians Advocacy Institute agreed. In a June 26 statement, the organization stated that it remains “deeply concerned that arbitrary, government-set payment benchmarks championed by the health insurance industry will further undermine provider networks and devastate patients’ access to critical medical services.”
A collective of hospital organizations, including the Federation of American Hospitals and the American Hospital Association also opposed the use of benchmark pricing.
In a June 25 letter to committee leadership, the groups stated that they are “concerned that the rate-setting provision of the legislation is a plan-determined, nontransparent process that will upend private payment negotiation. A default rate will become the payment ceiling and remove incentives for insurers to develop comprehensive networks, as there are already increasing numbers of narrow network products offered that exclude certain types of providers.”
The bill also addresses the cost of prescription drugs, including providing clearer information about patents, ensuring a more timely access to generics, altering exclusivity rules to help get generics to market quicker, reporting requirements for price increases, and a number of other provisions aimed at increasing competition in an effort to lower drug pricing.
Other areas covered by the bill include more oversight of pharmacy benefit managers, strengthening parity in mental health laws, and a number of provisions aimed at public health and health information technology.
A bill aimed at ending the practice of surprise billing, along with a number of other health care cost-containment measures, passed by an overwhelming majority during a mark-up session of the Senate Health, Education, Labor, and Pensions Committee.
S. 1895, the Lower Health Care Costs Act of 2019, passed 20-3; Sens. Rand Paul (R-Ky.), Bernie Sanders (D-Ver.) and Elizabeth Warren (D-Mass.) voted against it.
A summary of the bill’s provisions can be found here.
With Sen. Sanders and Sen. Warren not present, presumably out to prepare for the Democratic presidential nominee debates and voting by proxy, only Sen. Paul was present to speak against the bill. He questioned whether it would have any impact on lowering health care cost.
Among other provisions, the bill would ban all gag clauses that would keep pricing data from being released; all anticompetitive clauses in facility and insurance contracts that would otherwise limit access to higher-quality, lower-cost care; would designate a nongovernment entity focused on price transparency; and would improve the accuracy of directory information.
But government-induced transparency is not the solution, Sen. Paul said.
He called it a “fallacy” that “you can mandate transparency, and you’ll create a marketplace.” Rather, you need to create a marketplace, and transparency will naturally follow, he said.
Sen. Paul noted that just having institutions publishing prices that no one pays and prices that are not freely fluctuating “doesn’t work.”
“The irony here is that, when you have no insurance involved, you actually have a marketplace,” he said. “The people without insurance are the only true marketplace,” he said, adding that those with high deductibles would also fall into that category.
The crux of S. 1895 is protections to end so-called “surprise bills” that occur when patients receive medical services from out-of-network health care professionals at in-network hospitals. These out-of-network services are not constrained by prior agreements and can add up to tens of thousands of dollars.
“There are those who have seen the history of price controls and know that you never get what you intended,” he said, and predicted that this could lead to a shortage of physicians.
The American Medical Association also criticized the surprise billing provisions of the bill.
In a June 25 letter, the AMA noted that “the approach outlined in S. 1895 fails to address some of the fundamental reasons why surprise billing occurs – inadequate provider networks, higher patient-cost sharing requirements for out-of-network services, and noncompetitive local markets that empower plans to offer take-it-or-leave-it contracts.”
AMA also criticized the use of benchmark pricing to settle out-of-network billing issues. “By setting a payment maximum at the individual plans’ median in-network amount, insurers will have even less incentive to negotiate contracts with individual providers,” according to the letter. “They can drive down the median in-network amount by simply dropping from their networks providers who are currently paid above the median. Or, they can simply stop negotiating altogether, knowing that their financial obligation is limited to their own median in-network payment amounts.”
The Physicians Advocacy Institute agreed. In a June 26 statement, the organization stated that it remains “deeply concerned that arbitrary, government-set payment benchmarks championed by the health insurance industry will further undermine provider networks and devastate patients’ access to critical medical services.”
A collective of hospital organizations, including the Federation of American Hospitals and the American Hospital Association also opposed the use of benchmark pricing.
In a June 25 letter to committee leadership, the groups stated that they are “concerned that the rate-setting provision of the legislation is a plan-determined, nontransparent process that will upend private payment negotiation. A default rate will become the payment ceiling and remove incentives for insurers to develop comprehensive networks, as there are already increasing numbers of narrow network products offered that exclude certain types of providers.”
The bill also addresses the cost of prescription drugs, including providing clearer information about patents, ensuring a more timely access to generics, altering exclusivity rules to help get generics to market quicker, reporting requirements for price increases, and a number of other provisions aimed at increasing competition in an effort to lower drug pricing.
Other areas covered by the bill include more oversight of pharmacy benefit managers, strengthening parity in mental health laws, and a number of provisions aimed at public health and health information technology.
A bill aimed at ending the practice of surprise billing, along with a number of other health care cost-containment measures, passed by an overwhelming majority during a mark-up session of the Senate Health, Education, Labor, and Pensions Committee.
S. 1895, the Lower Health Care Costs Act of 2019, passed 20-3; Sens. Rand Paul (R-Ky.), Bernie Sanders (D-Ver.) and Elizabeth Warren (D-Mass.) voted against it.
A summary of the bill’s provisions can be found here.
With Sen. Sanders and Sen. Warren not present, presumably out to prepare for the Democratic presidential nominee debates and voting by proxy, only Sen. Paul was present to speak against the bill. He questioned whether it would have any impact on lowering health care cost.
Among other provisions, the bill would ban all gag clauses that would keep pricing data from being released; all anticompetitive clauses in facility and insurance contracts that would otherwise limit access to higher-quality, lower-cost care; would designate a nongovernment entity focused on price transparency; and would improve the accuracy of directory information.
But government-induced transparency is not the solution, Sen. Paul said.
He called it a “fallacy” that “you can mandate transparency, and you’ll create a marketplace.” Rather, you need to create a marketplace, and transparency will naturally follow, he said.
Sen. Paul noted that just having institutions publishing prices that no one pays and prices that are not freely fluctuating “doesn’t work.”
“The irony here is that, when you have no insurance involved, you actually have a marketplace,” he said. “The people without insurance are the only true marketplace,” he said, adding that those with high deductibles would also fall into that category.
The crux of S. 1895 is protections to end so-called “surprise bills” that occur when patients receive medical services from out-of-network health care professionals at in-network hospitals. These out-of-network services are not constrained by prior agreements and can add up to tens of thousands of dollars.
“There are those who have seen the history of price controls and know that you never get what you intended,” he said, and predicted that this could lead to a shortage of physicians.
The American Medical Association also criticized the surprise billing provisions of the bill.
In a June 25 letter, the AMA noted that “the approach outlined in S. 1895 fails to address some of the fundamental reasons why surprise billing occurs – inadequate provider networks, higher patient-cost sharing requirements for out-of-network services, and noncompetitive local markets that empower plans to offer take-it-or-leave-it contracts.”
AMA also criticized the use of benchmark pricing to settle out-of-network billing issues. “By setting a payment maximum at the individual plans’ median in-network amount, insurers will have even less incentive to negotiate contracts with individual providers,” according to the letter. “They can drive down the median in-network amount by simply dropping from their networks providers who are currently paid above the median. Or, they can simply stop negotiating altogether, knowing that their financial obligation is limited to their own median in-network payment amounts.”
The Physicians Advocacy Institute agreed. In a June 26 statement, the organization stated that it remains “deeply concerned that arbitrary, government-set payment benchmarks championed by the health insurance industry will further undermine provider networks and devastate patients’ access to critical medical services.”
A collective of hospital organizations, including the Federation of American Hospitals and the American Hospital Association also opposed the use of benchmark pricing.
In a June 25 letter to committee leadership, the groups stated that they are “concerned that the rate-setting provision of the legislation is a plan-determined, nontransparent process that will upend private payment negotiation. A default rate will become the payment ceiling and remove incentives for insurers to develop comprehensive networks, as there are already increasing numbers of narrow network products offered that exclude certain types of providers.”
The bill also addresses the cost of prescription drugs, including providing clearer information about patents, ensuring a more timely access to generics, altering exclusivity rules to help get generics to market quicker, reporting requirements for price increases, and a number of other provisions aimed at increasing competition in an effort to lower drug pricing.
Other areas covered by the bill include more oversight of pharmacy benefit managers, strengthening parity in mental health laws, and a number of provisions aimed at public health and health information technology.
REPORTING FROM A SENATE COMMITTEE MEETING
The 21st Century Cures Act: Tearing down fortresses to put patients first
"A fortress not only protects those inside of it, but it also enslaves them to work.”
– Anthony T. Hincks
As physicians, we spend a great deal of time intending to do our best for the people we serve. We believe fundamentally in the idea that our patients come first, and we toil daily to exercise that belief. We also want our patients to feel they are driving their care as active participants along the journey. Yet time and time again, despite our greatest attempts, those efforts are stymied by the state of modern medicine;
Over the past 10 years, we have done a tremendous job of constructing expensive fortresses around patient information known as electronic health records (EHRs). Billions of dollars have been spent implementing, upgrading, and optimizing. In spite of this, physicians are increasingly frustrated by EHRs (and in many cases, long to return to the days of paper). It isn’t surprising, then, that patients are frustrated as well. We use terms such as “patient-centered care,” but patients feel like they are not in the center at all. Instead, they can find themselves feeling like complete outsiders, at the mercy of the medical juggernaut to make sure they have the appropriate information when they need it. There are several issues that contribute to the frustrations of physicians and patients, but two in particular warrant attention. The first is the diversity of Health IT systems and ongoing issues with EHR interoperability. The second is a provincial attitude surrounding transparency and medical record ownership. We will discuss both of these here, as well as recent legislation designed to advance both concerns.
We have written in previous columns about the many challenges of interoperability. Electronic health records, sold by different vendors, typically won’t “talk” to each other. In spite of years of maturation, issues of compatibility remain. Patient data locked inside of one EHR is not easily accessible by a physician using a different EHR. While efforts have been made to streamline information sharing, there are still many fortresses that cannot be breached.
Bridging the moat
The 21st Century Cures Act, enacted by Congress in December of 2016, seeks to define and require interoperability while addressing many other significant problems in health care. According to the legislation, true interoperability means that health IT should enable the secure exchange of electronic health information with other electronic record systems without special effort on the part of the user; the process should be seamless and shouldn’t be cumbersome for physicians or patients. It also must be fully supported by EHR vendors, but those vendors have been expressing significant concerns with the ways in which the act is being interpreted.
In a recent blog post, the HIMSS Electronic Health Record Association – a consortium of vendors including Epic, Allscripts, eClinicalWorks, as well as several others – expressed “significant concerns regarding timelines, ambiguous language, disincentives for innovation, and definitions related to information blocking.”1 This is not surprising, as the onus for improving interoperability falls squarely on their shoulders, and the work to get there is arduous. Regardless of one’s interpretation, the goal of the Cures act is clear: Arrive at true interoperability in the shortest period of time, while eliminating barriers that prevent patients from accessing their health records. In other words, it asks for the avoidance of “information blocking.”
Breaching the gate
Information blocking, as defined by the Cures Act, is “a practice by a health care provider, health IT developer, health information exchange, or health information network that … is likely to interfere with, prevent, or materially discourage access, exchange, or use of electronic health information.”2 This practice is explicitly prohibited by the legislation – and is ethically wrong – yet it continues to occur implicitly every day as it has for many years. Even if unintentional and solely because of the growing complexity of our information systems, it makes accessing health information incredibly cumbersome for patients. Even worse, attempts to improve patients’ ability to access their health records have only created additional obstacles.
HIPAA (the Health Insurance Portability and Accountability Act of 1996) was designed to protect patient confidentiality and create security around protected health information. While noble in purpose, many have found it burdensome to work within the parameters set forth in the law. Physicians and patients needing legitimate access to clinical data discover endless release forms and convoluted processes standing in their way. Access to the information eventually comes in the form of reams of printed paper or faxed notes that cannot be easily consumed by or integrated into other systems.
The Meaningful Use initiative, while envisioned to improve data exchange and enhance population health, did little to help. Instead of enabling documentation efficiency and improving patient access, it promoted the proliferation of incompatible EHRs and poorly conceived patient portals. It also created heavy costs for both the federal government and physicians and was largely ineffective at producing systems whose use could be considered meaningful. The federal government paid out as much as $44,000 per physician to incentivize them to purchase medical records, while physicians often spent more than the $44,000 and, in many cases, wound up with EHRs that didn’t work well and had to be replaced.
Authors and supporters of the 21st Century Cures Act are hoping to avoid the shortcomings of prior legislation by attaching financial penalties to health care providers or IT vendors who engage in information blocking. While allowing for exceptions in appropriate cases, the law is clear: Patients deserve complete access to their medical records. While this goes against tradition, it has been proven to result in better outcomes.
Initiatives such as the OpenNotes movement have been pushing the value of full transparency for some time, and their website includes a long list of numerous examples to prove it. Indeed, several studies have demonstrated increased physician and patient satisfaction when both parties have ready access to health information. We believe that we, as physicians, should fully support the idea and lobby our EHR vendors to do the same.
It is time to tear down the impenetrable fortresses of traditional medicine, then work diligently to rebuild them with our patients safely inside.
Dr. Notte is a family physician and associate chief medical information officer for Abington (Pa.) Jefferson Health. Follow him on Twitter @doctornotte. Dr. Skolnik is a professor of family and community medicine at Jefferson Medical College, Philadelphia, and an associate director of the family medicine residency program at Abington Jefferson Health.
References
1. The Electronic Health Record Association blog
"A fortress not only protects those inside of it, but it also enslaves them to work.”
– Anthony T. Hincks
As physicians, we spend a great deal of time intending to do our best for the people we serve. We believe fundamentally in the idea that our patients come first, and we toil daily to exercise that belief. We also want our patients to feel they are driving their care as active participants along the journey. Yet time and time again, despite our greatest attempts, those efforts are stymied by the state of modern medicine;
Over the past 10 years, we have done a tremendous job of constructing expensive fortresses around patient information known as electronic health records (EHRs). Billions of dollars have been spent implementing, upgrading, and optimizing. In spite of this, physicians are increasingly frustrated by EHRs (and in many cases, long to return to the days of paper). It isn’t surprising, then, that patients are frustrated as well. We use terms such as “patient-centered care,” but patients feel like they are not in the center at all. Instead, they can find themselves feeling like complete outsiders, at the mercy of the medical juggernaut to make sure they have the appropriate information when they need it. There are several issues that contribute to the frustrations of physicians and patients, but two in particular warrant attention. The first is the diversity of Health IT systems and ongoing issues with EHR interoperability. The second is a provincial attitude surrounding transparency and medical record ownership. We will discuss both of these here, as well as recent legislation designed to advance both concerns.
We have written in previous columns about the many challenges of interoperability. Electronic health records, sold by different vendors, typically won’t “talk” to each other. In spite of years of maturation, issues of compatibility remain. Patient data locked inside of one EHR is not easily accessible by a physician using a different EHR. While efforts have been made to streamline information sharing, there are still many fortresses that cannot be breached.
Bridging the moat
The 21st Century Cures Act, enacted by Congress in December of 2016, seeks to define and require interoperability while addressing many other significant problems in health care. According to the legislation, true interoperability means that health IT should enable the secure exchange of electronic health information with other electronic record systems without special effort on the part of the user; the process should be seamless and shouldn’t be cumbersome for physicians or patients. It also must be fully supported by EHR vendors, but those vendors have been expressing significant concerns with the ways in which the act is being interpreted.
In a recent blog post, the HIMSS Electronic Health Record Association – a consortium of vendors including Epic, Allscripts, eClinicalWorks, as well as several others – expressed “significant concerns regarding timelines, ambiguous language, disincentives for innovation, and definitions related to information blocking.”1 This is not surprising, as the onus for improving interoperability falls squarely on their shoulders, and the work to get there is arduous. Regardless of one’s interpretation, the goal of the Cures act is clear: Arrive at true interoperability in the shortest period of time, while eliminating barriers that prevent patients from accessing their health records. In other words, it asks for the avoidance of “information blocking.”
Breaching the gate
Information blocking, as defined by the Cures Act, is “a practice by a health care provider, health IT developer, health information exchange, or health information network that … is likely to interfere with, prevent, or materially discourage access, exchange, or use of electronic health information.”2 This practice is explicitly prohibited by the legislation – and is ethically wrong – yet it continues to occur implicitly every day as it has for many years. Even if unintentional and solely because of the growing complexity of our information systems, it makes accessing health information incredibly cumbersome for patients. Even worse, attempts to improve patients’ ability to access their health records have only created additional obstacles.
HIPAA (the Health Insurance Portability and Accountability Act of 1996) was designed to protect patient confidentiality and create security around protected health information. While noble in purpose, many have found it burdensome to work within the parameters set forth in the law. Physicians and patients needing legitimate access to clinical data discover endless release forms and convoluted processes standing in their way. Access to the information eventually comes in the form of reams of printed paper or faxed notes that cannot be easily consumed by or integrated into other systems.
The Meaningful Use initiative, while envisioned to improve data exchange and enhance population health, did little to help. Instead of enabling documentation efficiency and improving patient access, it promoted the proliferation of incompatible EHRs and poorly conceived patient portals. It also created heavy costs for both the federal government and physicians and was largely ineffective at producing systems whose use could be considered meaningful. The federal government paid out as much as $44,000 per physician to incentivize them to purchase medical records, while physicians often spent more than the $44,000 and, in many cases, wound up with EHRs that didn’t work well and had to be replaced.
Authors and supporters of the 21st Century Cures Act are hoping to avoid the shortcomings of prior legislation by attaching financial penalties to health care providers or IT vendors who engage in information blocking. While allowing for exceptions in appropriate cases, the law is clear: Patients deserve complete access to their medical records. While this goes against tradition, it has been proven to result in better outcomes.
Initiatives such as the OpenNotes movement have been pushing the value of full transparency for some time, and their website includes a long list of numerous examples to prove it. Indeed, several studies have demonstrated increased physician and patient satisfaction when both parties have ready access to health information. We believe that we, as physicians, should fully support the idea and lobby our EHR vendors to do the same.
It is time to tear down the impenetrable fortresses of traditional medicine, then work diligently to rebuild them with our patients safely inside.
Dr. Notte is a family physician and associate chief medical information officer for Abington (Pa.) Jefferson Health. Follow him on Twitter @doctornotte. Dr. Skolnik is a professor of family and community medicine at Jefferson Medical College, Philadelphia, and an associate director of the family medicine residency program at Abington Jefferson Health.
References
1. The Electronic Health Record Association blog
"A fortress not only protects those inside of it, but it also enslaves them to work.”
– Anthony T. Hincks
As physicians, we spend a great deal of time intending to do our best for the people we serve. We believe fundamentally in the idea that our patients come first, and we toil daily to exercise that belief. We also want our patients to feel they are driving their care as active participants along the journey. Yet time and time again, despite our greatest attempts, those efforts are stymied by the state of modern medicine;
Over the past 10 years, we have done a tremendous job of constructing expensive fortresses around patient information known as electronic health records (EHRs). Billions of dollars have been spent implementing, upgrading, and optimizing. In spite of this, physicians are increasingly frustrated by EHRs (and in many cases, long to return to the days of paper). It isn’t surprising, then, that patients are frustrated as well. We use terms such as “patient-centered care,” but patients feel like they are not in the center at all. Instead, they can find themselves feeling like complete outsiders, at the mercy of the medical juggernaut to make sure they have the appropriate information when they need it. There are several issues that contribute to the frustrations of physicians and patients, but two in particular warrant attention. The first is the diversity of Health IT systems and ongoing issues with EHR interoperability. The second is a provincial attitude surrounding transparency and medical record ownership. We will discuss both of these here, as well as recent legislation designed to advance both concerns.
We have written in previous columns about the many challenges of interoperability. Electronic health records, sold by different vendors, typically won’t “talk” to each other. In spite of years of maturation, issues of compatibility remain. Patient data locked inside of one EHR is not easily accessible by a physician using a different EHR. While efforts have been made to streamline information sharing, there are still many fortresses that cannot be breached.
Bridging the moat
The 21st Century Cures Act, enacted by Congress in December of 2016, seeks to define and require interoperability while addressing many other significant problems in health care. According to the legislation, true interoperability means that health IT should enable the secure exchange of electronic health information with other electronic record systems without special effort on the part of the user; the process should be seamless and shouldn’t be cumbersome for physicians or patients. It also must be fully supported by EHR vendors, but those vendors have been expressing significant concerns with the ways in which the act is being interpreted.
In a recent blog post, the HIMSS Electronic Health Record Association – a consortium of vendors including Epic, Allscripts, eClinicalWorks, as well as several others – expressed “significant concerns regarding timelines, ambiguous language, disincentives for innovation, and definitions related to information blocking.”1 This is not surprising, as the onus for improving interoperability falls squarely on their shoulders, and the work to get there is arduous. Regardless of one’s interpretation, the goal of the Cures act is clear: Arrive at true interoperability in the shortest period of time, while eliminating barriers that prevent patients from accessing their health records. In other words, it asks for the avoidance of “information blocking.”
Breaching the gate
Information blocking, as defined by the Cures Act, is “a practice by a health care provider, health IT developer, health information exchange, or health information network that … is likely to interfere with, prevent, or materially discourage access, exchange, or use of electronic health information.”2 This practice is explicitly prohibited by the legislation – and is ethically wrong – yet it continues to occur implicitly every day as it has for many years. Even if unintentional and solely because of the growing complexity of our information systems, it makes accessing health information incredibly cumbersome for patients. Even worse, attempts to improve patients’ ability to access their health records have only created additional obstacles.
HIPAA (the Health Insurance Portability and Accountability Act of 1996) was designed to protect patient confidentiality and create security around protected health information. While noble in purpose, many have found it burdensome to work within the parameters set forth in the law. Physicians and patients needing legitimate access to clinical data discover endless release forms and convoluted processes standing in their way. Access to the information eventually comes in the form of reams of printed paper or faxed notes that cannot be easily consumed by or integrated into other systems.
The Meaningful Use initiative, while envisioned to improve data exchange and enhance population health, did little to help. Instead of enabling documentation efficiency and improving patient access, it promoted the proliferation of incompatible EHRs and poorly conceived patient portals. It also created heavy costs for both the federal government and physicians and was largely ineffective at producing systems whose use could be considered meaningful. The federal government paid out as much as $44,000 per physician to incentivize them to purchase medical records, while physicians often spent more than the $44,000 and, in many cases, wound up with EHRs that didn’t work well and had to be replaced.
Authors and supporters of the 21st Century Cures Act are hoping to avoid the shortcomings of prior legislation by attaching financial penalties to health care providers or IT vendors who engage in information blocking. While allowing for exceptions in appropriate cases, the law is clear: Patients deserve complete access to their medical records. While this goes against tradition, it has been proven to result in better outcomes.
Initiatives such as the OpenNotes movement have been pushing the value of full transparency for some time, and their website includes a long list of numerous examples to prove it. Indeed, several studies have demonstrated increased physician and patient satisfaction when both parties have ready access to health information. We believe that we, as physicians, should fully support the idea and lobby our EHR vendors to do the same.
It is time to tear down the impenetrable fortresses of traditional medicine, then work diligently to rebuild them with our patients safely inside.
Dr. Notte is a family physician and associate chief medical information officer for Abington (Pa.) Jefferson Health. Follow him on Twitter @doctornotte. Dr. Skolnik is a professor of family and community medicine at Jefferson Medical College, Philadelphia, and an associate director of the family medicine residency program at Abington Jefferson Health.
References
1. The Electronic Health Record Association blog
Subset of patients benefits from in-hospital sleep apnea screening
SAN ANTONIO – In the clinical opinion of Richard J. Schwab, MD,
“Many diseases are adversely affected by sleep apnea, including myocardial infarction, hypertension, a cerebrovascular accident, pulmonary hypertension, atrial fibrillation, diabetes, and congestive heart failure,” Dr. Schwab, interim chief of the University of Pennsylvania Perelman School of Medicine’s Division of Sleep Medicine, said at the annual meeting of the Associated Professional Sleep Societies.
“Continuous positive airway pressure [CPAP] may help heart failure patients and reduce 30-day readmission rates, which has important financial implications in the University of Pennsylvania Health system. CPAP may also decrease the rapid responses and cardiac arrests at night,” he said.
A few years ago, Dr. Schwab and his associates set out to determine whether PAP adherence in cardiac patients with sleep-disordered breathing reduced readmission rates 30 days after discharge (J Clin Sleep Med. 2014;10:1051-59). They evaluated 104 consecutive cardiovascular hospitalized patients reporting symptoms of sleep-disordered breathing (SDB) between January of 2012 and March of 2013, and collected demographic data, SDB type, PAP adherence, and data regarding 30-day hospital readmission/ED visits. Apnea was scored when there was a 90% or greater cessation of airflow detected through the nasal pressure sensor. Hypopnea was scored when there was at least a 50% reduction in airflow with an associated 3% or greater oxyhemoglobin desaturation. Central apnea (CSA) was scored when there was a 90% or greater cessation of airflow detected through the nasal pressure sensor and no effort in the thorax and abdomen. If more than 50% of the apneas were central, the SDB was classified as CSA. If more than 50% of apneas were obstructive in nature, it was considered obstructive sleep apnea (OSA).
The mean age of the patients was 59 years, 63% were male, their mean body mass index was 34 kg/m2, 87% had heart failure, and 82% had hypertension. Of the 104 patients, 81 had SDB and 23 did not. The 30-day readmission rate was 29% in patients who did not use PAP, 30% in partial users, and 0% in full users (P = .0246).
The researchers found that 81 patients (78%) had sleep disordered breathing. Of these, 65 (80%) had OSA while 16 (20%) had CSA. The study demonstrated that performing inpatient sleep studies was feasible. “Our study indicated that SDB is common in hospitalized cardiac patients, with the majority of patients manifesting OSA,” said Dr. Schwab, medical director of the Penn Sleep Centers. “The data suggest that hospital readmission and ED visits 30 days after discharge were significantly lower in patients with cardiac disease and SDB who adhere to PAP treatment than those who are not adherent.”
Dr. Schwab is part of a research team conducting a longer study with ResMed to examine 30-, 60-, and 90-day readmission rates in cardiac inpatients newly diagnosed with OSA and started on auto-PAP (APAP). They plan to evaluate the ejection fraction during hospitalization and in follow-up, as well as the effect of an in-laboratory sleep study at 1 month. The long-term follow-up is planned for 3 years.
Launching an inpatient sleep apnea consult service in the hospital makes sense, Dr. Schwab continued, because home sleep studies are approved for the diagnosis of sleep apnea, APAP can determine optimal CPAP settings, insurance will cover CPAP with a home or inpatient sleep study, and patients can get CPAP/APAP at or before discharge. “Sleep techs or respiratory therapists can perform these sleep studies,” he said. At Penn, a nurse practitioner (NP) runs this service using the Alice NightOne home sleep testing device and the WatchPAT portable sleep apnea diagnostic device.
The notion of performing in-hospital sleep studies should be an easy sell to cardiologists and hospital administrators, Dr. Schwab said, because the program will decrease hospital readmissions, “which is going to save the hospital a lot of money. In addition, these patients can come back for in-laboratory sleep studies. There is also increased revenue from the consults and progress notes, and the professional fee for sleep study interpretation. The most challenging part of the inpatient sleep consult service is trying to get these patients to follow up in the sleep center with the NP.”
Dr. Schwab is an investigator for the recently launched Penn Medicine Nudge Unit Project, which is funded by the National Institutes of Health. The project includes a multidisciplinary team of providers from the Hospital of the University of Pennsylvania, Penn Presbyterian Medical Center, and Penn Medicine Risk Management. If an inpatient has a BMI of 35 kg/m2 or greater, the clinician will be “nudged” via an enterprise messaging system (EMS) prompt to order an inpatient sleep oximetry. “They have to respond to that nudge,” Dr. Schwab said. “If the oximetry is consistent for sleep apnea, there will be another nudge to consult with the sleep medicine team. If the oximetry is negative, they will be nudged to get an outpatient consult with the sleep medicine team.” For patients undergoing preadmission testing for any type of surgery who score 4 or more on the STOP-Bang questionnaire (Chest 2016;149:631-38), the clinician is “nudged” to order an outpatient sleep consultation.
Benefits to such an approach, he said, include a decrease in resource allocation, shorter hospital stays, patient perceived improvement in quality of sleep, improved patient survey scores, and the fact that apnea treatment may decrease the need for rapid response. “It also reduces medical-legal concerns, improves patient outcomes, decreases readmissions, and generates revenue from inpatient and outpatient sleep studies,” Dr. Schwab said. Barriers to such an approach include the fact that there is no defined pathway at many institutions for recognizing and referring suspected OSA patients. “There is often a lack of care coordination between primary providers and sleep medicine, and sleep is viewed as ambulatory care, not as a part of inpatient care,” he said.
Last year, Dr. Schwab and his colleagues at UPenn conducted a pilot study to develop and test a pathway for identifying OSA in high-risk inpatient and preadmission patient populations. Of 389 patients admitted between Aug. 20 and Sept. 20 of 2018, 43 had a BMI of 35 kg/m2 or greater. Of these, 10 were screened with oximetry and 8 were positive for severe apnea. Of these eight cases, five inpatient consults were ordered, one outpatient consult was ordered, one patient had no consult ordered, and one patient was discharged before the consult was ordered.
Dr. Schwab also performed a pilot study in patients undergoing preoperative testing with the STOP-Bang questionnaire. “When we piloted this, there were over 200 patients who could have been sent to the outpatient sleep consult service, and we referred none,” Dr. Schwab said. “We are just starting to implement a program to screen them. We can treat these people for their sleep apnea and prevent chronic adverse sequelae associated with this disease.”
Both the inpatient and outpatient screening programs for sleep apnea are built within their electronic medical record. “Building this within your EMR requires effort, but it’s doable,” he said.
Dr. Schwab disclosed that he has received grants from the National Institutes of Health, ResMed, and Inspire Medical Systems.
SAN ANTONIO – In the clinical opinion of Richard J. Schwab, MD,
“Many diseases are adversely affected by sleep apnea, including myocardial infarction, hypertension, a cerebrovascular accident, pulmonary hypertension, atrial fibrillation, diabetes, and congestive heart failure,” Dr. Schwab, interim chief of the University of Pennsylvania Perelman School of Medicine’s Division of Sleep Medicine, said at the annual meeting of the Associated Professional Sleep Societies.
“Continuous positive airway pressure [CPAP] may help heart failure patients and reduce 30-day readmission rates, which has important financial implications in the University of Pennsylvania Health system. CPAP may also decrease the rapid responses and cardiac arrests at night,” he said.
A few years ago, Dr. Schwab and his associates set out to determine whether PAP adherence in cardiac patients with sleep-disordered breathing reduced readmission rates 30 days after discharge (J Clin Sleep Med. 2014;10:1051-59). They evaluated 104 consecutive cardiovascular hospitalized patients reporting symptoms of sleep-disordered breathing (SDB) between January of 2012 and March of 2013, and collected demographic data, SDB type, PAP adherence, and data regarding 30-day hospital readmission/ED visits. Apnea was scored when there was a 90% or greater cessation of airflow detected through the nasal pressure sensor. Hypopnea was scored when there was at least a 50% reduction in airflow with an associated 3% or greater oxyhemoglobin desaturation. Central apnea (CSA) was scored when there was a 90% or greater cessation of airflow detected through the nasal pressure sensor and no effort in the thorax and abdomen. If more than 50% of the apneas were central, the SDB was classified as CSA. If more than 50% of apneas were obstructive in nature, it was considered obstructive sleep apnea (OSA).
The mean age of the patients was 59 years, 63% were male, their mean body mass index was 34 kg/m2, 87% had heart failure, and 82% had hypertension. Of the 104 patients, 81 had SDB and 23 did not. The 30-day readmission rate was 29% in patients who did not use PAP, 30% in partial users, and 0% in full users (P = .0246).
The researchers found that 81 patients (78%) had sleep disordered breathing. Of these, 65 (80%) had OSA while 16 (20%) had CSA. The study demonstrated that performing inpatient sleep studies was feasible. “Our study indicated that SDB is common in hospitalized cardiac patients, with the majority of patients manifesting OSA,” said Dr. Schwab, medical director of the Penn Sleep Centers. “The data suggest that hospital readmission and ED visits 30 days after discharge were significantly lower in patients with cardiac disease and SDB who adhere to PAP treatment than those who are not adherent.”
Dr. Schwab is part of a research team conducting a longer study with ResMed to examine 30-, 60-, and 90-day readmission rates in cardiac inpatients newly diagnosed with OSA and started on auto-PAP (APAP). They plan to evaluate the ejection fraction during hospitalization and in follow-up, as well as the effect of an in-laboratory sleep study at 1 month. The long-term follow-up is planned for 3 years.
Launching an inpatient sleep apnea consult service in the hospital makes sense, Dr. Schwab continued, because home sleep studies are approved for the diagnosis of sleep apnea, APAP can determine optimal CPAP settings, insurance will cover CPAP with a home or inpatient sleep study, and patients can get CPAP/APAP at or before discharge. “Sleep techs or respiratory therapists can perform these sleep studies,” he said. At Penn, a nurse practitioner (NP) runs this service using the Alice NightOne home sleep testing device and the WatchPAT portable sleep apnea diagnostic device.
The notion of performing in-hospital sleep studies should be an easy sell to cardiologists and hospital administrators, Dr. Schwab said, because the program will decrease hospital readmissions, “which is going to save the hospital a lot of money. In addition, these patients can come back for in-laboratory sleep studies. There is also increased revenue from the consults and progress notes, and the professional fee for sleep study interpretation. The most challenging part of the inpatient sleep consult service is trying to get these patients to follow up in the sleep center with the NP.”
Dr. Schwab is an investigator for the recently launched Penn Medicine Nudge Unit Project, which is funded by the National Institutes of Health. The project includes a multidisciplinary team of providers from the Hospital of the University of Pennsylvania, Penn Presbyterian Medical Center, and Penn Medicine Risk Management. If an inpatient has a BMI of 35 kg/m2 or greater, the clinician will be “nudged” via an enterprise messaging system (EMS) prompt to order an inpatient sleep oximetry. “They have to respond to that nudge,” Dr. Schwab said. “If the oximetry is consistent for sleep apnea, there will be another nudge to consult with the sleep medicine team. If the oximetry is negative, they will be nudged to get an outpatient consult with the sleep medicine team.” For patients undergoing preadmission testing for any type of surgery who score 4 or more on the STOP-Bang questionnaire (Chest 2016;149:631-38), the clinician is “nudged” to order an outpatient sleep consultation.
Benefits to such an approach, he said, include a decrease in resource allocation, shorter hospital stays, patient perceived improvement in quality of sleep, improved patient survey scores, and the fact that apnea treatment may decrease the need for rapid response. “It also reduces medical-legal concerns, improves patient outcomes, decreases readmissions, and generates revenue from inpatient and outpatient sleep studies,” Dr. Schwab said. Barriers to such an approach include the fact that there is no defined pathway at many institutions for recognizing and referring suspected OSA patients. “There is often a lack of care coordination between primary providers and sleep medicine, and sleep is viewed as ambulatory care, not as a part of inpatient care,” he said.
Last year, Dr. Schwab and his colleagues at UPenn conducted a pilot study to develop and test a pathway for identifying OSA in high-risk inpatient and preadmission patient populations. Of 389 patients admitted between Aug. 20 and Sept. 20 of 2018, 43 had a BMI of 35 kg/m2 or greater. Of these, 10 were screened with oximetry and 8 were positive for severe apnea. Of these eight cases, five inpatient consults were ordered, one outpatient consult was ordered, one patient had no consult ordered, and one patient was discharged before the consult was ordered.
Dr. Schwab also performed a pilot study in patients undergoing preoperative testing with the STOP-Bang questionnaire. “When we piloted this, there were over 200 patients who could have been sent to the outpatient sleep consult service, and we referred none,” Dr. Schwab said. “We are just starting to implement a program to screen them. We can treat these people for their sleep apnea and prevent chronic adverse sequelae associated with this disease.”
Both the inpatient and outpatient screening programs for sleep apnea are built within their electronic medical record. “Building this within your EMR requires effort, but it’s doable,” he said.
Dr. Schwab disclosed that he has received grants from the National Institutes of Health, ResMed, and Inspire Medical Systems.
SAN ANTONIO – In the clinical opinion of Richard J. Schwab, MD,
“Many diseases are adversely affected by sleep apnea, including myocardial infarction, hypertension, a cerebrovascular accident, pulmonary hypertension, atrial fibrillation, diabetes, and congestive heart failure,” Dr. Schwab, interim chief of the University of Pennsylvania Perelman School of Medicine’s Division of Sleep Medicine, said at the annual meeting of the Associated Professional Sleep Societies.
“Continuous positive airway pressure [CPAP] may help heart failure patients and reduce 30-day readmission rates, which has important financial implications in the University of Pennsylvania Health system. CPAP may also decrease the rapid responses and cardiac arrests at night,” he said.
A few years ago, Dr. Schwab and his associates set out to determine whether PAP adherence in cardiac patients with sleep-disordered breathing reduced readmission rates 30 days after discharge (J Clin Sleep Med. 2014;10:1051-59). They evaluated 104 consecutive cardiovascular hospitalized patients reporting symptoms of sleep-disordered breathing (SDB) between January of 2012 and March of 2013, and collected demographic data, SDB type, PAP adherence, and data regarding 30-day hospital readmission/ED visits. Apnea was scored when there was a 90% or greater cessation of airflow detected through the nasal pressure sensor. Hypopnea was scored when there was at least a 50% reduction in airflow with an associated 3% or greater oxyhemoglobin desaturation. Central apnea (CSA) was scored when there was a 90% or greater cessation of airflow detected through the nasal pressure sensor and no effort in the thorax and abdomen. If more than 50% of the apneas were central, the SDB was classified as CSA. If more than 50% of apneas were obstructive in nature, it was considered obstructive sleep apnea (OSA).
The mean age of the patients was 59 years, 63% were male, their mean body mass index was 34 kg/m2, 87% had heart failure, and 82% had hypertension. Of the 104 patients, 81 had SDB and 23 did not. The 30-day readmission rate was 29% in patients who did not use PAP, 30% in partial users, and 0% in full users (P = .0246).
The researchers found that 81 patients (78%) had sleep disordered breathing. Of these, 65 (80%) had OSA while 16 (20%) had CSA. The study demonstrated that performing inpatient sleep studies was feasible. “Our study indicated that SDB is common in hospitalized cardiac patients, with the majority of patients manifesting OSA,” said Dr. Schwab, medical director of the Penn Sleep Centers. “The data suggest that hospital readmission and ED visits 30 days after discharge were significantly lower in patients with cardiac disease and SDB who adhere to PAP treatment than those who are not adherent.”
Dr. Schwab is part of a research team conducting a longer study with ResMed to examine 30-, 60-, and 90-day readmission rates in cardiac inpatients newly diagnosed with OSA and started on auto-PAP (APAP). They plan to evaluate the ejection fraction during hospitalization and in follow-up, as well as the effect of an in-laboratory sleep study at 1 month. The long-term follow-up is planned for 3 years.
Launching an inpatient sleep apnea consult service in the hospital makes sense, Dr. Schwab continued, because home sleep studies are approved for the diagnosis of sleep apnea, APAP can determine optimal CPAP settings, insurance will cover CPAP with a home or inpatient sleep study, and patients can get CPAP/APAP at or before discharge. “Sleep techs or respiratory therapists can perform these sleep studies,” he said. At Penn, a nurse practitioner (NP) runs this service using the Alice NightOne home sleep testing device and the WatchPAT portable sleep apnea diagnostic device.
The notion of performing in-hospital sleep studies should be an easy sell to cardiologists and hospital administrators, Dr. Schwab said, because the program will decrease hospital readmissions, “which is going to save the hospital a lot of money. In addition, these patients can come back for in-laboratory sleep studies. There is also increased revenue from the consults and progress notes, and the professional fee for sleep study interpretation. The most challenging part of the inpatient sleep consult service is trying to get these patients to follow up in the sleep center with the NP.”
Dr. Schwab is an investigator for the recently launched Penn Medicine Nudge Unit Project, which is funded by the National Institutes of Health. The project includes a multidisciplinary team of providers from the Hospital of the University of Pennsylvania, Penn Presbyterian Medical Center, and Penn Medicine Risk Management. If an inpatient has a BMI of 35 kg/m2 or greater, the clinician will be “nudged” via an enterprise messaging system (EMS) prompt to order an inpatient sleep oximetry. “They have to respond to that nudge,” Dr. Schwab said. “If the oximetry is consistent for sleep apnea, there will be another nudge to consult with the sleep medicine team. If the oximetry is negative, they will be nudged to get an outpatient consult with the sleep medicine team.” For patients undergoing preadmission testing for any type of surgery who score 4 or more on the STOP-Bang questionnaire (Chest 2016;149:631-38), the clinician is “nudged” to order an outpatient sleep consultation.
Benefits to such an approach, he said, include a decrease in resource allocation, shorter hospital stays, patient perceived improvement in quality of sleep, improved patient survey scores, and the fact that apnea treatment may decrease the need for rapid response. “It also reduces medical-legal concerns, improves patient outcomes, decreases readmissions, and generates revenue from inpatient and outpatient sleep studies,” Dr. Schwab said. Barriers to such an approach include the fact that there is no defined pathway at many institutions for recognizing and referring suspected OSA patients. “There is often a lack of care coordination between primary providers and sleep medicine, and sleep is viewed as ambulatory care, not as a part of inpatient care,” he said.
Last year, Dr. Schwab and his colleagues at UPenn conducted a pilot study to develop and test a pathway for identifying OSA in high-risk inpatient and preadmission patient populations. Of 389 patients admitted between Aug. 20 and Sept. 20 of 2018, 43 had a BMI of 35 kg/m2 or greater. Of these, 10 were screened with oximetry and 8 were positive for severe apnea. Of these eight cases, five inpatient consults were ordered, one outpatient consult was ordered, one patient had no consult ordered, and one patient was discharged before the consult was ordered.
Dr. Schwab also performed a pilot study in patients undergoing preoperative testing with the STOP-Bang questionnaire. “When we piloted this, there were over 200 patients who could have been sent to the outpatient sleep consult service, and we referred none,” Dr. Schwab said. “We are just starting to implement a program to screen them. We can treat these people for their sleep apnea and prevent chronic adverse sequelae associated with this disease.”
Both the inpatient and outpatient screening programs for sleep apnea are built within their electronic medical record. “Building this within your EMR requires effort, but it’s doable,” he said.
Dr. Schwab disclosed that he has received grants from the National Institutes of Health, ResMed, and Inspire Medical Systems.
EXPERT ANALYSIS FROM SLEEP 2019
MedPAC to Congress: End “incident-to” billing
Incident-to billing occurs when an advanced practicing registered nurse (APRN) or a physician assistant (PA) performs a service but bills Medicare under the physician’s national provider number and receives full physician fee schedule payment, as opposed to 85% of the fee under their own number.
“Medicare beneficiaries increasingly use APRNs and PAs for both primary and specialty care,” according to MedPAC’s June report. “APRNs are furnishing a larger share and a greater variety of services for Medicare beneficiaries than they did in the past. Despite this growing reliance, Medicare does not have a full accounting of the services delivered and beneficiaries treated.”
Currently, identical coding requirements obscure whether the physician or the APRN/PA is providing the service, making it difficult to track volume and quality.
MedPAC estimated that, in 2016, 17% of all nurse practitioners billed all their services as incident to, as that was the number of nurse practitioners who never appeared in the performing provider field for reimbursement but ordered services/drugs or at least one Medicare fee-for-service beneficiary.
Another 34% billed some of their services as incident to as their name appeared at least once in the performing provider they ordered services/drugs for, but ordered more services/drugs for patients where they were not listed as the performing provider.
That leaves just about half (49%) who did not billing their services as incident to.
Requiring APRNs and PAs to bill directly for all of their services provided would update Medicare’s payment policies to better reflect current clinical practice, according to the MedPAC report. “In addition to improving policy makers’ foundational knowledge of who provides care for Medicare beneficiaries, direct billing could create substantial benefits for the Medicare program, beneficiaries, clinicians, and researchers that range from improving the accuracy of the physician fee schedule, reducing expenditures, enhancing program integrity, and allowing for better comparisons between cost and quality of care provided by physicians and APRNs/PAs.”
At their October 2018 meeting, MedPAC commissioners discussed how to appropriately compensate APRNs and PAs, should incident-to billing be eliminated; they ultimately recommended maintaining the 85% rate.
The American Academy of Family Practitioners spoke out against the idea of eliminating incident-to billing.
However, lowering all APRN/PA payments to 85% of what physicians make would impact doctors in a negative way, according to AAFP President Michael Munger, MD.
Dr. Munger described primary care as a team sport, and “this is certainly going to be felt in terms of the overall mission of delivering quality care.”
Access to care also could be reduced along with the reduced payment level.
“You have to make business decisions at the end of the day,” he said in an interview. “You need to make sure that you can have adequate revenue to offset expenses, and if you are going to take a 15% cut in your revenue in, you have to look at where your expenses are, and obviously salary is your No. 1 expense. If you are not able to count on this revenue and you can’t afford to have NPs and PAs as part of the team, it is going to become an access issue for patients.”
The MedPAC commissioner saw it differently.
“Most of these clinicians are already paid at this lower rate, and yet the supply of these clinicians has increased dramatically over the last several years,” the report states, adding that the salary differential between these clinicians and physicians “is large enough that employing them likely would remain attractive even if all of their services were paid at 85% of physician fee schedule rates.”
MedPAC, as an advisory body to Congress, makes no disclosures.
Incident-to billing occurs when an advanced practicing registered nurse (APRN) or a physician assistant (PA) performs a service but bills Medicare under the physician’s national provider number and receives full physician fee schedule payment, as opposed to 85% of the fee under their own number.
“Medicare beneficiaries increasingly use APRNs and PAs for both primary and specialty care,” according to MedPAC’s June report. “APRNs are furnishing a larger share and a greater variety of services for Medicare beneficiaries than they did in the past. Despite this growing reliance, Medicare does not have a full accounting of the services delivered and beneficiaries treated.”
Currently, identical coding requirements obscure whether the physician or the APRN/PA is providing the service, making it difficult to track volume and quality.
MedPAC estimated that, in 2016, 17% of all nurse practitioners billed all their services as incident to, as that was the number of nurse practitioners who never appeared in the performing provider field for reimbursement but ordered services/drugs or at least one Medicare fee-for-service beneficiary.
Another 34% billed some of their services as incident to as their name appeared at least once in the performing provider they ordered services/drugs for, but ordered more services/drugs for patients where they were not listed as the performing provider.
That leaves just about half (49%) who did not billing their services as incident to.
Requiring APRNs and PAs to bill directly for all of their services provided would update Medicare’s payment policies to better reflect current clinical practice, according to the MedPAC report. “In addition to improving policy makers’ foundational knowledge of who provides care for Medicare beneficiaries, direct billing could create substantial benefits for the Medicare program, beneficiaries, clinicians, and researchers that range from improving the accuracy of the physician fee schedule, reducing expenditures, enhancing program integrity, and allowing for better comparisons between cost and quality of care provided by physicians and APRNs/PAs.”
At their October 2018 meeting, MedPAC commissioners discussed how to appropriately compensate APRNs and PAs, should incident-to billing be eliminated; they ultimately recommended maintaining the 85% rate.
The American Academy of Family Practitioners spoke out against the idea of eliminating incident-to billing.
However, lowering all APRN/PA payments to 85% of what physicians make would impact doctors in a negative way, according to AAFP President Michael Munger, MD.
Dr. Munger described primary care as a team sport, and “this is certainly going to be felt in terms of the overall mission of delivering quality care.”
Access to care also could be reduced along with the reduced payment level.
“You have to make business decisions at the end of the day,” he said in an interview. “You need to make sure that you can have adequate revenue to offset expenses, and if you are going to take a 15% cut in your revenue in, you have to look at where your expenses are, and obviously salary is your No. 1 expense. If you are not able to count on this revenue and you can’t afford to have NPs and PAs as part of the team, it is going to become an access issue for patients.”
The MedPAC commissioner saw it differently.
“Most of these clinicians are already paid at this lower rate, and yet the supply of these clinicians has increased dramatically over the last several years,” the report states, adding that the salary differential between these clinicians and physicians “is large enough that employing them likely would remain attractive even if all of their services were paid at 85% of physician fee schedule rates.”
MedPAC, as an advisory body to Congress, makes no disclosures.
Incident-to billing occurs when an advanced practicing registered nurse (APRN) or a physician assistant (PA) performs a service but bills Medicare under the physician’s national provider number and receives full physician fee schedule payment, as opposed to 85% of the fee under their own number.
“Medicare beneficiaries increasingly use APRNs and PAs for both primary and specialty care,” according to MedPAC’s June report. “APRNs are furnishing a larger share and a greater variety of services for Medicare beneficiaries than they did in the past. Despite this growing reliance, Medicare does not have a full accounting of the services delivered and beneficiaries treated.”
Currently, identical coding requirements obscure whether the physician or the APRN/PA is providing the service, making it difficult to track volume and quality.
MedPAC estimated that, in 2016, 17% of all nurse practitioners billed all their services as incident to, as that was the number of nurse practitioners who never appeared in the performing provider field for reimbursement but ordered services/drugs or at least one Medicare fee-for-service beneficiary.
Another 34% billed some of their services as incident to as their name appeared at least once in the performing provider they ordered services/drugs for, but ordered more services/drugs for patients where they were not listed as the performing provider.
That leaves just about half (49%) who did not billing their services as incident to.
Requiring APRNs and PAs to bill directly for all of their services provided would update Medicare’s payment policies to better reflect current clinical practice, according to the MedPAC report. “In addition to improving policy makers’ foundational knowledge of who provides care for Medicare beneficiaries, direct billing could create substantial benefits for the Medicare program, beneficiaries, clinicians, and researchers that range from improving the accuracy of the physician fee schedule, reducing expenditures, enhancing program integrity, and allowing for better comparisons between cost and quality of care provided by physicians and APRNs/PAs.”
At their October 2018 meeting, MedPAC commissioners discussed how to appropriately compensate APRNs and PAs, should incident-to billing be eliminated; they ultimately recommended maintaining the 85% rate.
The American Academy of Family Practitioners spoke out against the idea of eliminating incident-to billing.
However, lowering all APRN/PA payments to 85% of what physicians make would impact doctors in a negative way, according to AAFP President Michael Munger, MD.
Dr. Munger described primary care as a team sport, and “this is certainly going to be felt in terms of the overall mission of delivering quality care.”
Access to care also could be reduced along with the reduced payment level.
“You have to make business decisions at the end of the day,” he said in an interview. “You need to make sure that you can have adequate revenue to offset expenses, and if you are going to take a 15% cut in your revenue in, you have to look at where your expenses are, and obviously salary is your No. 1 expense. If you are not able to count on this revenue and you can’t afford to have NPs and PAs as part of the team, it is going to become an access issue for patients.”
The MedPAC commissioner saw it differently.
“Most of these clinicians are already paid at this lower rate, and yet the supply of these clinicians has increased dramatically over the last several years,” the report states, adding that the salary differential between these clinicians and physicians “is large enough that employing them likely would remain attractive even if all of their services were paid at 85% of physician fee schedule rates.”
MedPAC, as an advisory body to Congress, makes no disclosures.
Medicare may best Medicare Advantage at reducing readmissions
Although earlier research may suggest otherwise, traditional new research suggests.
Researchers used what they described as “a novel data linkage” comparing 30-day readmission rates after hospitalization for three major conditions in the Hospital Readmissions Reduction Program for patients using traditional Medicare versus Medicare Advantage. Those conditions included acute MI, heart failure, and pneumonia.
“Our results contrast with those of previous studies that have reported lower or statistically similar readmission rates for Medicare Advantage beneficiaries,” Orestis A. Panagiotou, MD, of Brown University, Providence, R.I., and colleagues wrote in a research report published in Annals of Internal Medicine.
In this retrospective cohort study, the researchers linked data from 2011 to 2014 from the Medicare Provider Analysis and Review (MedPAR) file to the Healthcare Effectiveness Data and Information Set (HEDIS).
The novel linkage found that HEDIS data underreported hospital admissions for acute MI, heart failure, and pneumonia, the researchers stated. “Plans incorrectly excluded hospitalizations that should have qualified for the readmission measure, and readmission rates were substantially higher among incorrectly excluded hospitalizations.”
Despite this, in analyses using the linkage of HEDIS and MedPAR, “Medicare Advantage beneficiaries had higher 30-day risk-adjusted readmission rates after [acute MI, heart failure, and pneumonia] than did traditional Medicare beneficiaries,” the investigators noted.
Patients in Medicare Advantage had lower unadjusted readmission rates compared with those in traditional Medicare (16.6% vs. 17.1% for acute MI; 21.4% vs. 21.7% for heart failure; and 16.3% vs. 16.4% for pneumonia). After standardization, Medicare Advantage patients had higher readmission rates, compared with those in traditional Medicare (17.2% vs. 16.9% for acute MI; 21.7% vs. 21.4% for heart failure; and 16.5% vs. 16.0% for pneumonia).
The study authors added that, while unadjusted readmission rates were higher for traditional Medicare beneficiaries, “the direction of the difference reversed after standardization. This occurred because Medicare Advantage beneficiaries have, on average, a lower expected readmission risk [that is, they are ‘healthier’].” Prior studies have documented that Medicare Advantage plans enroll beneficiaries with fewer comorbid conditions and that high-cost beneficiaries switch out of Medicare Advantage and into traditional Medicare.
The researchers suggested four reasons for the differences between the results in this study versus others that compared patients using Medicare with those using Medicare Advantage. These were that the new study included a more comprehensive data set, analyses with comorbid conditions “from a well-validated model applied by CMS [Centers for Medicare & Medicaid Services],” national data focused on three conditions included in the Hospital Readmissions Reduction Program, and patients discharged to places other than skilled nursing facilities and inpatient rehabilitation facilities.
Authors of an accompanying editorial called for caution to be used in interpreting Medicare Advantage enrollment as causing an increased readmission risk.
“[The] results are sensitive to adjustment for case mix,” wrote Peter Huckfeldt, PhD, of the University of Minnesota, Minneapolis, and Neeraj Sood, PhD, of the University of Southern California, Los Angeles, in the editorial published in Annals of Internal Medicine (2019 June 25. doi:10.7326/M19-1599) “Using diagnosis codes on hospital claims for case-mix adjustments may be increasingly perilous. ... To our knowledge, there is no recent evidence comparing the intensity of diagnostic coding between clinically similar [traditional Medicare] and [Medicare Advantage] hospital admissions, but if [traditional Medicare] enrollees were coded more intensively than [Medicare Advantage] enrollees, this could lead to [traditional Medicare] enrollees having lower risk-adjusted readmission rares due to coding practices.”
The editorialists added that using a cross-sectional comparison of Medicare Advantage and traditional Medicare patients is concerning because a “key challenge in estimating the effect of [Medicare Advantage] is that enrollment is voluntary,” which can lead to a number of analytical concerns.
The researchers concluded that their findings “are concerning because CMS uses HEDIS performance to construct composite quality ratings and assign payment bonuses to Medicare Advantage plans.
“Our study suggests a need for improved monitoring of the accuracy of HEDIS data,” they noted.
The National Institute on Aging provided the primary funding for this study. A number of the authors received grants from the National Institutes of Health during the conduct of the study. No other relevant disclosures were reported.
SOURCE: Panagiotou OA et al. Ann Intern Med. 2019 Jun 25. doi: 10.7326/M18-1795.
Although earlier research may suggest otherwise, traditional new research suggests.
Researchers used what they described as “a novel data linkage” comparing 30-day readmission rates after hospitalization for three major conditions in the Hospital Readmissions Reduction Program for patients using traditional Medicare versus Medicare Advantage. Those conditions included acute MI, heart failure, and pneumonia.
“Our results contrast with those of previous studies that have reported lower or statistically similar readmission rates for Medicare Advantage beneficiaries,” Orestis A. Panagiotou, MD, of Brown University, Providence, R.I., and colleagues wrote in a research report published in Annals of Internal Medicine.
In this retrospective cohort study, the researchers linked data from 2011 to 2014 from the Medicare Provider Analysis and Review (MedPAR) file to the Healthcare Effectiveness Data and Information Set (HEDIS).
The novel linkage found that HEDIS data underreported hospital admissions for acute MI, heart failure, and pneumonia, the researchers stated. “Plans incorrectly excluded hospitalizations that should have qualified for the readmission measure, and readmission rates were substantially higher among incorrectly excluded hospitalizations.”
Despite this, in analyses using the linkage of HEDIS and MedPAR, “Medicare Advantage beneficiaries had higher 30-day risk-adjusted readmission rates after [acute MI, heart failure, and pneumonia] than did traditional Medicare beneficiaries,” the investigators noted.
Patients in Medicare Advantage had lower unadjusted readmission rates compared with those in traditional Medicare (16.6% vs. 17.1% for acute MI; 21.4% vs. 21.7% for heart failure; and 16.3% vs. 16.4% for pneumonia). After standardization, Medicare Advantage patients had higher readmission rates, compared with those in traditional Medicare (17.2% vs. 16.9% for acute MI; 21.7% vs. 21.4% for heart failure; and 16.5% vs. 16.0% for pneumonia).
The study authors added that, while unadjusted readmission rates were higher for traditional Medicare beneficiaries, “the direction of the difference reversed after standardization. This occurred because Medicare Advantage beneficiaries have, on average, a lower expected readmission risk [that is, they are ‘healthier’].” Prior studies have documented that Medicare Advantage plans enroll beneficiaries with fewer comorbid conditions and that high-cost beneficiaries switch out of Medicare Advantage and into traditional Medicare.
The researchers suggested four reasons for the differences between the results in this study versus others that compared patients using Medicare with those using Medicare Advantage. These were that the new study included a more comprehensive data set, analyses with comorbid conditions “from a well-validated model applied by CMS [Centers for Medicare & Medicaid Services],” national data focused on three conditions included in the Hospital Readmissions Reduction Program, and patients discharged to places other than skilled nursing facilities and inpatient rehabilitation facilities.
Authors of an accompanying editorial called for caution to be used in interpreting Medicare Advantage enrollment as causing an increased readmission risk.
“[The] results are sensitive to adjustment for case mix,” wrote Peter Huckfeldt, PhD, of the University of Minnesota, Minneapolis, and Neeraj Sood, PhD, of the University of Southern California, Los Angeles, in the editorial published in Annals of Internal Medicine (2019 June 25. doi:10.7326/M19-1599) “Using diagnosis codes on hospital claims for case-mix adjustments may be increasingly perilous. ... To our knowledge, there is no recent evidence comparing the intensity of diagnostic coding between clinically similar [traditional Medicare] and [Medicare Advantage] hospital admissions, but if [traditional Medicare] enrollees were coded more intensively than [Medicare Advantage] enrollees, this could lead to [traditional Medicare] enrollees having lower risk-adjusted readmission rares due to coding practices.”
The editorialists added that using a cross-sectional comparison of Medicare Advantage and traditional Medicare patients is concerning because a “key challenge in estimating the effect of [Medicare Advantage] is that enrollment is voluntary,” which can lead to a number of analytical concerns.
The researchers concluded that their findings “are concerning because CMS uses HEDIS performance to construct composite quality ratings and assign payment bonuses to Medicare Advantage plans.
“Our study suggests a need for improved monitoring of the accuracy of HEDIS data,” they noted.
The National Institute on Aging provided the primary funding for this study. A number of the authors received grants from the National Institutes of Health during the conduct of the study. No other relevant disclosures were reported.
SOURCE: Panagiotou OA et al. Ann Intern Med. 2019 Jun 25. doi: 10.7326/M18-1795.
Although earlier research may suggest otherwise, traditional new research suggests.
Researchers used what they described as “a novel data linkage” comparing 30-day readmission rates after hospitalization for three major conditions in the Hospital Readmissions Reduction Program for patients using traditional Medicare versus Medicare Advantage. Those conditions included acute MI, heart failure, and pneumonia.
“Our results contrast with those of previous studies that have reported lower or statistically similar readmission rates for Medicare Advantage beneficiaries,” Orestis A. Panagiotou, MD, of Brown University, Providence, R.I., and colleagues wrote in a research report published in Annals of Internal Medicine.
In this retrospective cohort study, the researchers linked data from 2011 to 2014 from the Medicare Provider Analysis and Review (MedPAR) file to the Healthcare Effectiveness Data and Information Set (HEDIS).
The novel linkage found that HEDIS data underreported hospital admissions for acute MI, heart failure, and pneumonia, the researchers stated. “Plans incorrectly excluded hospitalizations that should have qualified for the readmission measure, and readmission rates were substantially higher among incorrectly excluded hospitalizations.”
Despite this, in analyses using the linkage of HEDIS and MedPAR, “Medicare Advantage beneficiaries had higher 30-day risk-adjusted readmission rates after [acute MI, heart failure, and pneumonia] than did traditional Medicare beneficiaries,” the investigators noted.
Patients in Medicare Advantage had lower unadjusted readmission rates compared with those in traditional Medicare (16.6% vs. 17.1% for acute MI; 21.4% vs. 21.7% for heart failure; and 16.3% vs. 16.4% for pneumonia). After standardization, Medicare Advantage patients had higher readmission rates, compared with those in traditional Medicare (17.2% vs. 16.9% for acute MI; 21.7% vs. 21.4% for heart failure; and 16.5% vs. 16.0% for pneumonia).
The study authors added that, while unadjusted readmission rates were higher for traditional Medicare beneficiaries, “the direction of the difference reversed after standardization. This occurred because Medicare Advantage beneficiaries have, on average, a lower expected readmission risk [that is, they are ‘healthier’].” Prior studies have documented that Medicare Advantage plans enroll beneficiaries with fewer comorbid conditions and that high-cost beneficiaries switch out of Medicare Advantage and into traditional Medicare.
The researchers suggested four reasons for the differences between the results in this study versus others that compared patients using Medicare with those using Medicare Advantage. These were that the new study included a more comprehensive data set, analyses with comorbid conditions “from a well-validated model applied by CMS [Centers for Medicare & Medicaid Services],” national data focused on three conditions included in the Hospital Readmissions Reduction Program, and patients discharged to places other than skilled nursing facilities and inpatient rehabilitation facilities.
Authors of an accompanying editorial called for caution to be used in interpreting Medicare Advantage enrollment as causing an increased readmission risk.
“[The] results are sensitive to adjustment for case mix,” wrote Peter Huckfeldt, PhD, of the University of Minnesota, Minneapolis, and Neeraj Sood, PhD, of the University of Southern California, Los Angeles, in the editorial published in Annals of Internal Medicine (2019 June 25. doi:10.7326/M19-1599) “Using diagnosis codes on hospital claims for case-mix adjustments may be increasingly perilous. ... To our knowledge, there is no recent evidence comparing the intensity of diagnostic coding between clinically similar [traditional Medicare] and [Medicare Advantage] hospital admissions, but if [traditional Medicare] enrollees were coded more intensively than [Medicare Advantage] enrollees, this could lead to [traditional Medicare] enrollees having lower risk-adjusted readmission rares due to coding practices.”
The editorialists added that using a cross-sectional comparison of Medicare Advantage and traditional Medicare patients is concerning because a “key challenge in estimating the effect of [Medicare Advantage] is that enrollment is voluntary,” which can lead to a number of analytical concerns.
The researchers concluded that their findings “are concerning because CMS uses HEDIS performance to construct composite quality ratings and assign payment bonuses to Medicare Advantage plans.
“Our study suggests a need for improved monitoring of the accuracy of HEDIS data,” they noted.
The National Institute on Aging provided the primary funding for this study. A number of the authors received grants from the National Institutes of Health during the conduct of the study. No other relevant disclosures were reported.
SOURCE: Panagiotou OA et al. Ann Intern Med. 2019 Jun 25. doi: 10.7326/M18-1795.
FROM ANNALS OF INTERNAL MEDICINE
Imaging predicts early postural instability in Parkinson’s disease
PHILADELPHIA – Diffusion-weighted MRI and the presence of at least five of seven clinical features may prove useful for determining which newly diagnosed patients with Parkinson’s disease are likely to have rapidly progressive disease, Frank M. Skidmore, MD, reported at the annual meeting of the American Academy of Neurology.
Patients with gray matter and axonal disease on initial imaging were found to have more aggressive disease associated with early gait dysfunction than were patients with primarily white matter and axonal disease, said Dr. Skidmore, associate professor of neurology at the University of Alabama, Birmingham.
Diffusion-weighted imaging provides a way to assess cellular fluid partitioning and directional information in gray and white matter. Thus, it has the potential to identify brainstem pathology that is associated with disease progression, he said. “Our approach provides a pathway towards using MR to detect early, prognostic, neurodegenerative changes in diseases of the brain.”
Dr. Skidmore and colleagues performed diffusion-weighted imaging on 101 patients with newly diagnosed Parkinson’s disease and 56 healthy controls. They found that Parkinson’s disease was associated with altered radial diffusion in white matter. Changes were observed mainly in the striatonigral tract and the substantia nigra. The investigators also noted atrophy in the cerebellar peduncle among patients with Parkinson’s disease.
At baseline, the patients who went on to have subsequent development of early postural instability and gait dysfunction had decreased intracellular fluid partitioning in the substantia nigra and the mesencephalic locomotor region, which are predominantly gray matter regions. These participants had a lower orientation diffusion index (ODI) and a lower estimate of cellularity, Dr. Skidmore said.
The researchers defined early gait dysfunction as the achievement of a Hoehn and Yahr score of 3 at least once while on medication during the first 5 years after Parkinson’s disease diagnosis. Follow-up was at least 5 years in 79 of the patients.
To identify clinical features associated with early postural instability and gait difficulty, the investigators examined data for 301 patients. In this population, Dr. Skidmore and colleagues identified 218 patients whose Hoehn and Yahr scores never exceeded 2 and 83 patients with at least one Hoehn and Yahr score of 3 or more. Using Bonferroni correction, they examined Unified Parkinson’s Disease Rating Scale (UPDRS) data for all patients to identify significant differences between these two groups. Seven items distinguished patients who developed early postural instability and gait difficulty. They included lightheadedness, fatigue, difficulty walking, ability to rise from a chair, and postural problems. The seven-item scale was superior to the Unified Parkinson’s Disease Rating Scale (UPDRS) at predicting which newly diagnosed patients would develop early postural and gait difficulties
SOURCE: Skidmore F et al. AANN 2019, Abstract S41.004.
PHILADELPHIA – Diffusion-weighted MRI and the presence of at least five of seven clinical features may prove useful for determining which newly diagnosed patients with Parkinson’s disease are likely to have rapidly progressive disease, Frank M. Skidmore, MD, reported at the annual meeting of the American Academy of Neurology.
Patients with gray matter and axonal disease on initial imaging were found to have more aggressive disease associated with early gait dysfunction than were patients with primarily white matter and axonal disease, said Dr. Skidmore, associate professor of neurology at the University of Alabama, Birmingham.
Diffusion-weighted imaging provides a way to assess cellular fluid partitioning and directional information in gray and white matter. Thus, it has the potential to identify brainstem pathology that is associated with disease progression, he said. “Our approach provides a pathway towards using MR to detect early, prognostic, neurodegenerative changes in diseases of the brain.”
Dr. Skidmore and colleagues performed diffusion-weighted imaging on 101 patients with newly diagnosed Parkinson’s disease and 56 healthy controls. They found that Parkinson’s disease was associated with altered radial diffusion in white matter. Changes were observed mainly in the striatonigral tract and the substantia nigra. The investigators also noted atrophy in the cerebellar peduncle among patients with Parkinson’s disease.
At baseline, the patients who went on to have subsequent development of early postural instability and gait dysfunction had decreased intracellular fluid partitioning in the substantia nigra and the mesencephalic locomotor region, which are predominantly gray matter regions. These participants had a lower orientation diffusion index (ODI) and a lower estimate of cellularity, Dr. Skidmore said.
The researchers defined early gait dysfunction as the achievement of a Hoehn and Yahr score of 3 at least once while on medication during the first 5 years after Parkinson’s disease diagnosis. Follow-up was at least 5 years in 79 of the patients.
To identify clinical features associated with early postural instability and gait difficulty, the investigators examined data for 301 patients. In this population, Dr. Skidmore and colleagues identified 218 patients whose Hoehn and Yahr scores never exceeded 2 and 83 patients with at least one Hoehn and Yahr score of 3 or more. Using Bonferroni correction, they examined Unified Parkinson’s Disease Rating Scale (UPDRS) data for all patients to identify significant differences between these two groups. Seven items distinguished patients who developed early postural instability and gait difficulty. They included lightheadedness, fatigue, difficulty walking, ability to rise from a chair, and postural problems. The seven-item scale was superior to the Unified Parkinson’s Disease Rating Scale (UPDRS) at predicting which newly diagnosed patients would develop early postural and gait difficulties
SOURCE: Skidmore F et al. AANN 2019, Abstract S41.004.
PHILADELPHIA – Diffusion-weighted MRI and the presence of at least five of seven clinical features may prove useful for determining which newly diagnosed patients with Parkinson’s disease are likely to have rapidly progressive disease, Frank M. Skidmore, MD, reported at the annual meeting of the American Academy of Neurology.
Patients with gray matter and axonal disease on initial imaging were found to have more aggressive disease associated with early gait dysfunction than were patients with primarily white matter and axonal disease, said Dr. Skidmore, associate professor of neurology at the University of Alabama, Birmingham.
Diffusion-weighted imaging provides a way to assess cellular fluid partitioning and directional information in gray and white matter. Thus, it has the potential to identify brainstem pathology that is associated with disease progression, he said. “Our approach provides a pathway towards using MR to detect early, prognostic, neurodegenerative changes in diseases of the brain.”
Dr. Skidmore and colleagues performed diffusion-weighted imaging on 101 patients with newly diagnosed Parkinson’s disease and 56 healthy controls. They found that Parkinson’s disease was associated with altered radial diffusion in white matter. Changes were observed mainly in the striatonigral tract and the substantia nigra. The investigators also noted atrophy in the cerebellar peduncle among patients with Parkinson’s disease.
At baseline, the patients who went on to have subsequent development of early postural instability and gait dysfunction had decreased intracellular fluid partitioning in the substantia nigra and the mesencephalic locomotor region, which are predominantly gray matter regions. These participants had a lower orientation diffusion index (ODI) and a lower estimate of cellularity, Dr. Skidmore said.
The researchers defined early gait dysfunction as the achievement of a Hoehn and Yahr score of 3 at least once while on medication during the first 5 years after Parkinson’s disease diagnosis. Follow-up was at least 5 years in 79 of the patients.
To identify clinical features associated with early postural instability and gait difficulty, the investigators examined data for 301 patients. In this population, Dr. Skidmore and colleagues identified 218 patients whose Hoehn and Yahr scores never exceeded 2 and 83 patients with at least one Hoehn and Yahr score of 3 or more. Using Bonferroni correction, they examined Unified Parkinson’s Disease Rating Scale (UPDRS) data for all patients to identify significant differences between these two groups. Seven items distinguished patients who developed early postural instability and gait difficulty. They included lightheadedness, fatigue, difficulty walking, ability to rise from a chair, and postural problems. The seven-item scale was superior to the Unified Parkinson’s Disease Rating Scale (UPDRS) at predicting which newly diagnosed patients would develop early postural and gait difficulties
SOURCE: Skidmore F et al. AANN 2019, Abstract S41.004.
REPORTING FROM AAN 2019
Trump administration seeks more health care cost details for consumers
Anyone who has tried to “shop” for hospital services knows one thing: It’s hard to get prices.
President Donald Trump on Monday signed an executive order he said would make it easier.
The order directs agencies to draw up rules requiring hospitals and insurers to make public more information on the negotiated prices they hammer out in contract negotiations. Also, hospitals and insurers would have to give estimates to patients on out-of-pocket costs before they go in for nonemergency medical care.
The move, which officials said will help address skyrocketing health care costs, comes amid other efforts by the administration to elicit more price transparency for medical care and initiatives by Congress to limit so-called surprise bills. These are the often-expensive bills consumers get when they unwittingly receive care that is not covered by their insurers.
“This will put American patients in control and address fundamental drivers of health care costs in a way no president has done before,” said Health & Human Services Secretary Alex Azar during a press briefing on Monday.
The proposal is likely to run into opposition from some hospitals and insurers who say disclosing negotiated rates could instead drive up costs.
Just how useful the effort will prove for consumers is unclear.
Much depends on how the administration writes the rules governing what information must be provided, such as whether it will include hospital-specific prices, regional averages, or other measures. While the administration calls for a “consumer-friendly” format, it’s not clear how such a massive amount of data – potentially negotiated price information from thousands of hospitals and insurers for tens of thousands of services – will be presented to consumers.
“It’s well intended, but may grossly overestimate the ability of the average patient to decipher this information overload,” said Dan Ward, a vice president at Waystar, a health care payments service.
So, does this new development advance efforts to better arm consumers with pricing information? Some key point to consider:
Q: What does the order do?
It may expand on price information consumers receive.
The order directs agencies to develop rules to require hospitals and insurers to provide information “based on negotiated rates” to the public.
Currently, such rates are hard to get, even for patients, until after medical care is provided. That’s when insured patients get an “explanation of benefits [EOBs],” which shows how much the hospital charged, how much of a discount their insurer received, and the amount a patient may owe.
In addition to consumers being unable to get price information upfront in many cases, hospital list prices and negotiated discount rates vary widely by hospital and insurer, even in a region. Uninsured patients often are charged the full amounts.
“People are sick and tired of hospitals playing these games with prices,” said George Nation, a business professor at Lehigh University in Bethlehem, Pa. who studies hospital contract law. “That’s what’s driving all of this.”
Some insurers and hospitals do provide online tools or apps that can help individual patients estimate out-of-pocket costs for a service or procedure ahead of time, but research shows few patients use such tools. Also, many medical services are needed without much notice – think of a heart attack or a broken leg – so shopping simply isn’t possible.
Administration officials say they want patients to have access to more information, including “advance EOBs” outlining anticipated costs before patients get nonemergency medical care. In theory, that would allow consumers to shop around for lower-cost care.
Q: Isn’t this information already available?
Not exactly. In January, new rules took effect under the Affordable Care Act that require hospitals to post online their “list prices,” which hospitals set themselves and have little relation to actual costs or what insurers actually pay.
What resulted are often confusing spreadsheets that contain thousands of a la carte charges – ranging from the price of medicines and sutures to room costs, among other things – that patients have to piece together if they can to estimate their total bill. Also, those list charges don’t reflect the discounted rates insurers have negotiated, so they are of little use to insured patients who might want to compare prices hospital to hospital.
The information that would result from President Trump’s executive order would provide more detail based on negotiated, discounted rates.
A senior administration official at the press briefing said details about whether the rates would be aggregated or relate to individual hospitals would be spelled out only when the administration puts forward proposed rules to implement the order later this year. It also is unclear how the administration would enforce the rules.
Another limitation: The order applies only to hospitals and the medical staff they employ. Many hospitals, however, are staffed by doctors who are not directly employed, or laboratories that are also separate. That means negotiated prices for services provided by such laboratories or physicians would not have to be disclosed.
Q: How could consumers use this information?
In theory, consumers could get information allowing them to compare prices for, say, a hip replacement or knee surgery in advance.
But that could prove difficult if the rates were not fairly hospital specific, or if they were not lumped in with all the care needed for a specific procedure or surgery.
“They could take the top 20 common procedures the hospital does, for example, and put negotiated prices on them,” said Mr. Nation. “It makes sense to do an average for that particular hospital, so I can see how much it’s going to cost to have my knee replaced at St. Joe’s versus St. Anne’s.”
Having advance notice of out-of-pocket costs could also help patients who have high-deductible plans.
“Patients are increasingly subject to insurance deductibles and other forms of substantial cost sharing. For a subset of so-called shoppable services, patients would benefit from price estimates in advance that allow them to compare options and plan financially for their care,” said John Rother, president and CEO at the advocacy group National Coalition on Health Care.
Q: Will this push consumers to shop for health care?
The short answer is maybe. Right now, it’s difficult, even with some of the tools available, said Lovisa Gustafsson, assistant vice president at the Commonwealth Fund, which has looked at whether patients use existing tools or the list price information hospitals must post online.
“The evidence to date shows patients aren’t necessarily the best shoppers, but we haven’t given them the best tools to be shoppers,” she said.
Posting negotiated rates might be a step forward, she said, but only if it is easily understandable.
It’s possible that insurers, physician offices, consumer groups, or online businesses may find ways to help direct patients to the most cost-effective locations for surgeries, tests or other procedures based on the information.
“Institutions like Consumer Reports or Consumer Checkbook could do some kind of high-level comparison between facilities or doctors, giving some general information that might be useful for consumers,” said Tim Jost, a professor emeritus at the Washington and Lee University School of Law in Lexington, Va.
But some hospitals and insurers maintain that disclosing specific rates could backfire.
Hospitals charging lower rates, for example, might raise them if they see competitors are getting higher reimbursement from insurers, they say. Insurers say they might be hampered in their ability to negotiate if rivals all know what they each pay.
“We also agree that patients should have accurate, real-time information about costs so they can make the best, most informed decisions about their care,” said a statement from lobbying group America’s Health Insurance Plans. “But publicly disclosing competitively negotiated, proprietary rates will reduce competition and push prices higher – not lower – for consumers, patients, and taxpayers.”
Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.
Anyone who has tried to “shop” for hospital services knows one thing: It’s hard to get prices.
President Donald Trump on Monday signed an executive order he said would make it easier.
The order directs agencies to draw up rules requiring hospitals and insurers to make public more information on the negotiated prices they hammer out in contract negotiations. Also, hospitals and insurers would have to give estimates to patients on out-of-pocket costs before they go in for nonemergency medical care.
The move, which officials said will help address skyrocketing health care costs, comes amid other efforts by the administration to elicit more price transparency for medical care and initiatives by Congress to limit so-called surprise bills. These are the often-expensive bills consumers get when they unwittingly receive care that is not covered by their insurers.
“This will put American patients in control and address fundamental drivers of health care costs in a way no president has done before,” said Health & Human Services Secretary Alex Azar during a press briefing on Monday.
The proposal is likely to run into opposition from some hospitals and insurers who say disclosing negotiated rates could instead drive up costs.
Just how useful the effort will prove for consumers is unclear.
Much depends on how the administration writes the rules governing what information must be provided, such as whether it will include hospital-specific prices, regional averages, or other measures. While the administration calls for a “consumer-friendly” format, it’s not clear how such a massive amount of data – potentially negotiated price information from thousands of hospitals and insurers for tens of thousands of services – will be presented to consumers.
“It’s well intended, but may grossly overestimate the ability of the average patient to decipher this information overload,” said Dan Ward, a vice president at Waystar, a health care payments service.
So, does this new development advance efforts to better arm consumers with pricing information? Some key point to consider:
Q: What does the order do?
It may expand on price information consumers receive.
The order directs agencies to develop rules to require hospitals and insurers to provide information “based on negotiated rates” to the public.
Currently, such rates are hard to get, even for patients, until after medical care is provided. That’s when insured patients get an “explanation of benefits [EOBs],” which shows how much the hospital charged, how much of a discount their insurer received, and the amount a patient may owe.
In addition to consumers being unable to get price information upfront in many cases, hospital list prices and negotiated discount rates vary widely by hospital and insurer, even in a region. Uninsured patients often are charged the full amounts.
“People are sick and tired of hospitals playing these games with prices,” said George Nation, a business professor at Lehigh University in Bethlehem, Pa. who studies hospital contract law. “That’s what’s driving all of this.”
Some insurers and hospitals do provide online tools or apps that can help individual patients estimate out-of-pocket costs for a service or procedure ahead of time, but research shows few patients use such tools. Also, many medical services are needed without much notice – think of a heart attack or a broken leg – so shopping simply isn’t possible.
Administration officials say they want patients to have access to more information, including “advance EOBs” outlining anticipated costs before patients get nonemergency medical care. In theory, that would allow consumers to shop around for lower-cost care.
Q: Isn’t this information already available?
Not exactly. In January, new rules took effect under the Affordable Care Act that require hospitals to post online their “list prices,” which hospitals set themselves and have little relation to actual costs or what insurers actually pay.
What resulted are often confusing spreadsheets that contain thousands of a la carte charges – ranging from the price of medicines and sutures to room costs, among other things – that patients have to piece together if they can to estimate their total bill. Also, those list charges don’t reflect the discounted rates insurers have negotiated, so they are of little use to insured patients who might want to compare prices hospital to hospital.
The information that would result from President Trump’s executive order would provide more detail based on negotiated, discounted rates.
A senior administration official at the press briefing said details about whether the rates would be aggregated or relate to individual hospitals would be spelled out only when the administration puts forward proposed rules to implement the order later this year. It also is unclear how the administration would enforce the rules.
Another limitation: The order applies only to hospitals and the medical staff they employ. Many hospitals, however, are staffed by doctors who are not directly employed, or laboratories that are also separate. That means negotiated prices for services provided by such laboratories or physicians would not have to be disclosed.
Q: How could consumers use this information?
In theory, consumers could get information allowing them to compare prices for, say, a hip replacement or knee surgery in advance.
But that could prove difficult if the rates were not fairly hospital specific, or if they were not lumped in with all the care needed for a specific procedure or surgery.
“They could take the top 20 common procedures the hospital does, for example, and put negotiated prices on them,” said Mr. Nation. “It makes sense to do an average for that particular hospital, so I can see how much it’s going to cost to have my knee replaced at St. Joe’s versus St. Anne’s.”
Having advance notice of out-of-pocket costs could also help patients who have high-deductible plans.
“Patients are increasingly subject to insurance deductibles and other forms of substantial cost sharing. For a subset of so-called shoppable services, patients would benefit from price estimates in advance that allow them to compare options and plan financially for their care,” said John Rother, president and CEO at the advocacy group National Coalition on Health Care.
Q: Will this push consumers to shop for health care?
The short answer is maybe. Right now, it’s difficult, even with some of the tools available, said Lovisa Gustafsson, assistant vice president at the Commonwealth Fund, which has looked at whether patients use existing tools or the list price information hospitals must post online.
“The evidence to date shows patients aren’t necessarily the best shoppers, but we haven’t given them the best tools to be shoppers,” she said.
Posting negotiated rates might be a step forward, she said, but only if it is easily understandable.
It’s possible that insurers, physician offices, consumer groups, or online businesses may find ways to help direct patients to the most cost-effective locations for surgeries, tests or other procedures based on the information.
“Institutions like Consumer Reports or Consumer Checkbook could do some kind of high-level comparison between facilities or doctors, giving some general information that might be useful for consumers,” said Tim Jost, a professor emeritus at the Washington and Lee University School of Law in Lexington, Va.
But some hospitals and insurers maintain that disclosing specific rates could backfire.
Hospitals charging lower rates, for example, might raise them if they see competitors are getting higher reimbursement from insurers, they say. Insurers say they might be hampered in their ability to negotiate if rivals all know what they each pay.
“We also agree that patients should have accurate, real-time information about costs so they can make the best, most informed decisions about their care,” said a statement from lobbying group America’s Health Insurance Plans. “But publicly disclosing competitively negotiated, proprietary rates will reduce competition and push prices higher – not lower – for consumers, patients, and taxpayers.”
Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.
Anyone who has tried to “shop” for hospital services knows one thing: It’s hard to get prices.
President Donald Trump on Monday signed an executive order he said would make it easier.
The order directs agencies to draw up rules requiring hospitals and insurers to make public more information on the negotiated prices they hammer out in contract negotiations. Also, hospitals and insurers would have to give estimates to patients on out-of-pocket costs before they go in for nonemergency medical care.
The move, which officials said will help address skyrocketing health care costs, comes amid other efforts by the administration to elicit more price transparency for medical care and initiatives by Congress to limit so-called surprise bills. These are the often-expensive bills consumers get when they unwittingly receive care that is not covered by their insurers.
“This will put American patients in control and address fundamental drivers of health care costs in a way no president has done before,” said Health & Human Services Secretary Alex Azar during a press briefing on Monday.
The proposal is likely to run into opposition from some hospitals and insurers who say disclosing negotiated rates could instead drive up costs.
Just how useful the effort will prove for consumers is unclear.
Much depends on how the administration writes the rules governing what information must be provided, such as whether it will include hospital-specific prices, regional averages, or other measures. While the administration calls for a “consumer-friendly” format, it’s not clear how such a massive amount of data – potentially negotiated price information from thousands of hospitals and insurers for tens of thousands of services – will be presented to consumers.
“It’s well intended, but may grossly overestimate the ability of the average patient to decipher this information overload,” said Dan Ward, a vice president at Waystar, a health care payments service.
So, does this new development advance efforts to better arm consumers with pricing information? Some key point to consider:
Q: What does the order do?
It may expand on price information consumers receive.
The order directs agencies to develop rules to require hospitals and insurers to provide information “based on negotiated rates” to the public.
Currently, such rates are hard to get, even for patients, until after medical care is provided. That’s when insured patients get an “explanation of benefits [EOBs],” which shows how much the hospital charged, how much of a discount their insurer received, and the amount a patient may owe.
In addition to consumers being unable to get price information upfront in many cases, hospital list prices and negotiated discount rates vary widely by hospital and insurer, even in a region. Uninsured patients often are charged the full amounts.
“People are sick and tired of hospitals playing these games with prices,” said George Nation, a business professor at Lehigh University in Bethlehem, Pa. who studies hospital contract law. “That’s what’s driving all of this.”
Some insurers and hospitals do provide online tools or apps that can help individual patients estimate out-of-pocket costs for a service or procedure ahead of time, but research shows few patients use such tools. Also, many medical services are needed without much notice – think of a heart attack or a broken leg – so shopping simply isn’t possible.
Administration officials say they want patients to have access to more information, including “advance EOBs” outlining anticipated costs before patients get nonemergency medical care. In theory, that would allow consumers to shop around for lower-cost care.
Q: Isn’t this information already available?
Not exactly. In January, new rules took effect under the Affordable Care Act that require hospitals to post online their “list prices,” which hospitals set themselves and have little relation to actual costs or what insurers actually pay.
What resulted are often confusing spreadsheets that contain thousands of a la carte charges – ranging from the price of medicines and sutures to room costs, among other things – that patients have to piece together if they can to estimate their total bill. Also, those list charges don’t reflect the discounted rates insurers have negotiated, so they are of little use to insured patients who might want to compare prices hospital to hospital.
The information that would result from President Trump’s executive order would provide more detail based on negotiated, discounted rates.
A senior administration official at the press briefing said details about whether the rates would be aggregated or relate to individual hospitals would be spelled out only when the administration puts forward proposed rules to implement the order later this year. It also is unclear how the administration would enforce the rules.
Another limitation: The order applies only to hospitals and the medical staff they employ. Many hospitals, however, are staffed by doctors who are not directly employed, or laboratories that are also separate. That means negotiated prices for services provided by such laboratories or physicians would not have to be disclosed.
Q: How could consumers use this information?
In theory, consumers could get information allowing them to compare prices for, say, a hip replacement or knee surgery in advance.
But that could prove difficult if the rates were not fairly hospital specific, or if they were not lumped in with all the care needed for a specific procedure or surgery.
“They could take the top 20 common procedures the hospital does, for example, and put negotiated prices on them,” said Mr. Nation. “It makes sense to do an average for that particular hospital, so I can see how much it’s going to cost to have my knee replaced at St. Joe’s versus St. Anne’s.”
Having advance notice of out-of-pocket costs could also help patients who have high-deductible plans.
“Patients are increasingly subject to insurance deductibles and other forms of substantial cost sharing. For a subset of so-called shoppable services, patients would benefit from price estimates in advance that allow them to compare options and plan financially for their care,” said John Rother, president and CEO at the advocacy group National Coalition on Health Care.
Q: Will this push consumers to shop for health care?
The short answer is maybe. Right now, it’s difficult, even with some of the tools available, said Lovisa Gustafsson, assistant vice president at the Commonwealth Fund, which has looked at whether patients use existing tools or the list price information hospitals must post online.
“The evidence to date shows patients aren’t necessarily the best shoppers, but we haven’t given them the best tools to be shoppers,” she said.
Posting negotiated rates might be a step forward, she said, but only if it is easily understandable.
It’s possible that insurers, physician offices, consumer groups, or online businesses may find ways to help direct patients to the most cost-effective locations for surgeries, tests or other procedures based on the information.
“Institutions like Consumer Reports or Consumer Checkbook could do some kind of high-level comparison between facilities or doctors, giving some general information that might be useful for consumers,” said Tim Jost, a professor emeritus at the Washington and Lee University School of Law in Lexington, Va.
But some hospitals and insurers maintain that disclosing specific rates could backfire.
Hospitals charging lower rates, for example, might raise them if they see competitors are getting higher reimbursement from insurers, they say. Insurers say they might be hampered in their ability to negotiate if rivals all know what they each pay.
“We also agree that patients should have accurate, real-time information about costs so they can make the best, most informed decisions about their care,” said a statement from lobbying group America’s Health Insurance Plans. “But publicly disclosing competitively negotiated, proprietary rates will reduce competition and push prices higher – not lower – for consumers, patients, and taxpayers.”
Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.