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CMS seeks input to develop SGR replacement regulations
WASHINGTON – The Centers for Medicare & Medicaid Services has asked the public to comment on rule making for new physician payment models.
The request for information (RFI) is open through Oct. 29, 2015, and seeks input on Section 101 of the Medicare Access and CHIP Reauthorization Act (MACRA) passed earlier this year to replace the Sustainable Growth Rate (SGR).
Section 101 replaces the SGR with regularly scheduled physician fee service updates, including higher rates for those participating in alternative payment models. The portion of the law also consolidates a number of previous quality metrics programs, such as the Physician Quality Reporting System, the Value-Based Payment Modifier, and the meaningful use program, and replaces them with merit incentive payment systems (MIPS).
In addition, Section 101 of the MACRA gives physicians and other eligible professionals incentive to create additional, so-called, “physician-focused payment models.”
Dr. Patrick Conway, Deputy Administrator for Innovation and Quality and CMS Chief Medical Officer, wrote at HealthAffairs.org that he hopes eligible “stakeholders will take this opportunity to provide input through the RFI. … and our goal is to help providers be successful while reducing administrative burden.”
The public can review and comment on Section 101 of MACRA.
On Twitter @whitneymcknight
WASHINGTON – The Centers for Medicare & Medicaid Services has asked the public to comment on rule making for new physician payment models.
The request for information (RFI) is open through Oct. 29, 2015, and seeks input on Section 101 of the Medicare Access and CHIP Reauthorization Act (MACRA) passed earlier this year to replace the Sustainable Growth Rate (SGR).
Section 101 replaces the SGR with regularly scheduled physician fee service updates, including higher rates for those participating in alternative payment models. The portion of the law also consolidates a number of previous quality metrics programs, such as the Physician Quality Reporting System, the Value-Based Payment Modifier, and the meaningful use program, and replaces them with merit incentive payment systems (MIPS).
In addition, Section 101 of the MACRA gives physicians and other eligible professionals incentive to create additional, so-called, “physician-focused payment models.”
Dr. Patrick Conway, Deputy Administrator for Innovation and Quality and CMS Chief Medical Officer, wrote at HealthAffairs.org that he hopes eligible “stakeholders will take this opportunity to provide input through the RFI. … and our goal is to help providers be successful while reducing administrative burden.”
The public can review and comment on Section 101 of MACRA.
On Twitter @whitneymcknight
WASHINGTON – The Centers for Medicare & Medicaid Services has asked the public to comment on rule making for new physician payment models.
The request for information (RFI) is open through Oct. 29, 2015, and seeks input on Section 101 of the Medicare Access and CHIP Reauthorization Act (MACRA) passed earlier this year to replace the Sustainable Growth Rate (SGR).
Section 101 replaces the SGR with regularly scheduled physician fee service updates, including higher rates for those participating in alternative payment models. The portion of the law also consolidates a number of previous quality metrics programs, such as the Physician Quality Reporting System, the Value-Based Payment Modifier, and the meaningful use program, and replaces them with merit incentive payment systems (MIPS).
In addition, Section 101 of the MACRA gives physicians and other eligible professionals incentive to create additional, so-called, “physician-focused payment models.”
Dr. Patrick Conway, Deputy Administrator for Innovation and Quality and CMS Chief Medical Officer, wrote at HealthAffairs.org that he hopes eligible “stakeholders will take this opportunity to provide input through the RFI. … and our goal is to help providers be successful while reducing administrative burden.”
The public can review and comment on Section 101 of MACRA.
On Twitter @whitneymcknight
AUDIO: Meaningful use interoperability ‘won’t work without the Internet’
WASHINGTON – The rules for Stage 3 of the meaningful use program have been finalized by the Obama administration, despite questions about physicians’ ability to achieve “interoperability” and pleas from politicians and providers alike to delay its implementation.
Jonathan Bush, cofounder and CEO of athenahealth, said he believes interoperability will be a no-go unless data are seen as common property, and a premium is placed on the seamless transition of medical records by way of the Internet, not faxes.
Speaking about the large sums of money being spent by hospitals to comply with the government’s meaningful use requirements, Mr. Bush said, “they’re going to staff up hundreds of people who aren’t going to be able to run it. It doesn’t connect to anyone.”
In an interview at the annual Washington Ideas Forum sponsored by the Aspen Institute and The Atlantic, Mr. Bush offered his thoughts on how data could be more easily shared.
On Twitter @whitneymcknight
WASHINGTON – The rules for Stage 3 of the meaningful use program have been finalized by the Obama administration, despite questions about physicians’ ability to achieve “interoperability” and pleas from politicians and providers alike to delay its implementation.
Jonathan Bush, cofounder and CEO of athenahealth, said he believes interoperability will be a no-go unless data are seen as common property, and a premium is placed on the seamless transition of medical records by way of the Internet, not faxes.
Speaking about the large sums of money being spent by hospitals to comply with the government’s meaningful use requirements, Mr. Bush said, “they’re going to staff up hundreds of people who aren’t going to be able to run it. It doesn’t connect to anyone.”
In an interview at the annual Washington Ideas Forum sponsored by the Aspen Institute and The Atlantic, Mr. Bush offered his thoughts on how data could be more easily shared.
On Twitter @whitneymcknight
WASHINGTON – The rules for Stage 3 of the meaningful use program have been finalized by the Obama administration, despite questions about physicians’ ability to achieve “interoperability” and pleas from politicians and providers alike to delay its implementation.
Jonathan Bush, cofounder and CEO of athenahealth, said he believes interoperability will be a no-go unless data are seen as common property, and a premium is placed on the seamless transition of medical records by way of the Internet, not faxes.
Speaking about the large sums of money being spent by hospitals to comply with the government’s meaningful use requirements, Mr. Bush said, “they’re going to staff up hundreds of people who aren’t going to be able to run it. It doesn’t connect to anyone.”
In an interview at the annual Washington Ideas Forum sponsored by the Aspen Institute and The Atlantic, Mr. Bush offered his thoughts on how data could be more easily shared.
On Twitter @whitneymcknight
EXPERT ANALYSIS FROM THE WASHINGTON IDEAS FORUM
GAO: Physicians, hospitals struggle to achieve EHR interoperability
Physicians and health care organizations are struggling to achieve interoperability, the exchange of data between their electronic health records systems, according to a U.S. Government Accountability Office report.
The report comes as more federal lawmakers press the Obama administration to slow the start of the third stage of Meaningful Use requirements for EHRs.
The GAO interviewed 18 private companies working to enhance the interoperability of electronic health records at the request of Sen. Lamar Alexander (R-Tenn.), chair of the Senate Committee on Health, Education, Labor & Pensions.
In its report, the GAO found five key challenges that are preventing EHR interoperability:
• Insufficiencies in standards for EHR interoperability.
• Variations in states’ privacy rules.
• Difficulties in accurately matching patients’ health records.
• The costs associated with interoperability.
• A need for governance and trust among the providers and organizations using EHRs.
Many of the organizations surveyed said that the Meaningful Use requirements, passed as part of the 2009 federal stimulus and being implemented in stages, focus more on rules than on the criteria necessary to test the various systems’ ability to interoperate.
Three of the industry representatives surveyed suggested that the Obama administration should at least amend the EHR incentives law to focus on testing systems’ interoperability, while five others called for suspending or scrapping the law altogether.
“We are glad to see the GAO shining a light on the problem,” Dan Haley, Athena Health senior vice president and general counsel, said in an interview. Athena Health was not among those surveyed for the report.
“Nobody who lives and works in the 21st century can possibly dispute the proposition that information technology has the potential to vastly improve the quality and efficiency of health care delivery,” Mr. Haley noted. “Unfortunately, the Meaningful Use program, while well intentioned, has become burdened by granular requirements that impede rather than enhance care providers’ ability to maximize that potential, and do nothing to improve the interoperability of disparate technology platforms.”
Meanwhile, 116 members of the U.S. House of Representatives have signed a letter addressed to both Office of Management and Budget Director Shaun Donovan and U.S. Department of Health & Human Services Secretary Sylvia M. Burwell, asking them to delay the third stage of the law’s implementation until there’s a clearer picture of what metrics will be in the recently passed Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), which have just opened up for public comment.
“It’s time that we focus on interoperability instead of rulemaking to ensure that these products work for our nation’s providers,” Rep. Renee Ellmers (R-N.C.) said in a statement. “If the administration dives into Stage 3 prematurely, we only stand to aggravate providers and vendors who have already experienced ample challenges in meeting attestation deadlines.”
The Centers for Medicare & Medicaid Services sent the final rule for Stage 3 of Meaningful Use to the Office of Management and Budget in September. The next stage is set to take effect in 2017.
On Twitter @whitneymcknight
Physicians and health care organizations are struggling to achieve interoperability, the exchange of data between their electronic health records systems, according to a U.S. Government Accountability Office report.
The report comes as more federal lawmakers press the Obama administration to slow the start of the third stage of Meaningful Use requirements for EHRs.
The GAO interviewed 18 private companies working to enhance the interoperability of electronic health records at the request of Sen. Lamar Alexander (R-Tenn.), chair of the Senate Committee on Health, Education, Labor & Pensions.
In its report, the GAO found five key challenges that are preventing EHR interoperability:
• Insufficiencies in standards for EHR interoperability.
• Variations in states’ privacy rules.
• Difficulties in accurately matching patients’ health records.
• The costs associated with interoperability.
• A need for governance and trust among the providers and organizations using EHRs.
Many of the organizations surveyed said that the Meaningful Use requirements, passed as part of the 2009 federal stimulus and being implemented in stages, focus more on rules than on the criteria necessary to test the various systems’ ability to interoperate.
Three of the industry representatives surveyed suggested that the Obama administration should at least amend the EHR incentives law to focus on testing systems’ interoperability, while five others called for suspending or scrapping the law altogether.
“We are glad to see the GAO shining a light on the problem,” Dan Haley, Athena Health senior vice president and general counsel, said in an interview. Athena Health was not among those surveyed for the report.
“Nobody who lives and works in the 21st century can possibly dispute the proposition that information technology has the potential to vastly improve the quality and efficiency of health care delivery,” Mr. Haley noted. “Unfortunately, the Meaningful Use program, while well intentioned, has become burdened by granular requirements that impede rather than enhance care providers’ ability to maximize that potential, and do nothing to improve the interoperability of disparate technology platforms.”
Meanwhile, 116 members of the U.S. House of Representatives have signed a letter addressed to both Office of Management and Budget Director Shaun Donovan and U.S. Department of Health & Human Services Secretary Sylvia M. Burwell, asking them to delay the third stage of the law’s implementation until there’s a clearer picture of what metrics will be in the recently passed Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), which have just opened up for public comment.
“It’s time that we focus on interoperability instead of rulemaking to ensure that these products work for our nation’s providers,” Rep. Renee Ellmers (R-N.C.) said in a statement. “If the administration dives into Stage 3 prematurely, we only stand to aggravate providers and vendors who have already experienced ample challenges in meeting attestation deadlines.”
The Centers for Medicare & Medicaid Services sent the final rule for Stage 3 of Meaningful Use to the Office of Management and Budget in September. The next stage is set to take effect in 2017.
On Twitter @whitneymcknight
Physicians and health care organizations are struggling to achieve interoperability, the exchange of data between their electronic health records systems, according to a U.S. Government Accountability Office report.
The report comes as more federal lawmakers press the Obama administration to slow the start of the third stage of Meaningful Use requirements for EHRs.
The GAO interviewed 18 private companies working to enhance the interoperability of electronic health records at the request of Sen. Lamar Alexander (R-Tenn.), chair of the Senate Committee on Health, Education, Labor & Pensions.
In its report, the GAO found five key challenges that are preventing EHR interoperability:
• Insufficiencies in standards for EHR interoperability.
• Variations in states’ privacy rules.
• Difficulties in accurately matching patients’ health records.
• The costs associated with interoperability.
• A need for governance and trust among the providers and organizations using EHRs.
Many of the organizations surveyed said that the Meaningful Use requirements, passed as part of the 2009 federal stimulus and being implemented in stages, focus more on rules than on the criteria necessary to test the various systems’ ability to interoperate.
Three of the industry representatives surveyed suggested that the Obama administration should at least amend the EHR incentives law to focus on testing systems’ interoperability, while five others called for suspending or scrapping the law altogether.
“We are glad to see the GAO shining a light on the problem,” Dan Haley, Athena Health senior vice president and general counsel, said in an interview. Athena Health was not among those surveyed for the report.
“Nobody who lives and works in the 21st century can possibly dispute the proposition that information technology has the potential to vastly improve the quality and efficiency of health care delivery,” Mr. Haley noted. “Unfortunately, the Meaningful Use program, while well intentioned, has become burdened by granular requirements that impede rather than enhance care providers’ ability to maximize that potential, and do nothing to improve the interoperability of disparate technology platforms.”
Meanwhile, 116 members of the U.S. House of Representatives have signed a letter addressed to both Office of Management and Budget Director Shaun Donovan and U.S. Department of Health & Human Services Secretary Sylvia M. Burwell, asking them to delay the third stage of the law’s implementation until there’s a clearer picture of what metrics will be in the recently passed Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), which have just opened up for public comment.
“It’s time that we focus on interoperability instead of rulemaking to ensure that these products work for our nation’s providers,” Rep. Renee Ellmers (R-N.C.) said in a statement. “If the administration dives into Stage 3 prematurely, we only stand to aggravate providers and vendors who have already experienced ample challenges in meeting attestation deadlines.”
The Centers for Medicare & Medicaid Services sent the final rule for Stage 3 of Meaningful Use to the Office of Management and Budget in September. The next stage is set to take effect in 2017.
On Twitter @whitneymcknight
Embracing ICD-10: Physician documentation in a new era
Physicians’ fears of handling the transition to ICD-10 are likely not rooted in reality, especially in the hospital setting, industry experts say.
“There are just a few things physicians need to learn how to do that they’re not doing already, and they will learn pretty quickly,” said Dr. Anthony Oliva, vice president and chief medical officer of the health division of Nuance Communications, a Boston-based consulting firm, in an interview. Previously, Dr. Oliva was chief medical officer for the Borgess Health in Kalamazoo, Mich.
Dr. Oliva cites as an example a patient with a history of heart failure. In addition to noting that he has a history of cardiomyopathy secondary to ischemia and a history of decreased left ventricular function, a provider also must indicate that the patient has “chronic systolic failure,” according to Dr. Oliva, who says that failing to add these three words could mean not aligning with the diagnostic group logic being used in the ICD-10 code set, and thus not being reimbursed accordingly.
Although physicians might roll their eyes at this, Dr. Oliva, himself a family practice physician, says it’s better than having to memorize “a zillion” code combinations. “The majority of what we see is hypertension, diabetes, some kidney disease, and some GI disease, so you can just pare down what you have to know, and what you have to document. It becomes manageable. It’s more about documenting than it is about coding,” says Dr. Oliva. For specialists, it’s even easier he says, since they need only know a narrow swathe of the more than 70,000 ICD-10 codes. Dr. Oliva says that in time, health system coders likely will reveal to physicians the codes they must know for the documentation they are doing most often.
“In bigger practices with coding support, it will be the coders working with their providers to get the precision,” says Dr. Daniel Ari Mendelson, an associate chief of medicine at Highland Hospital in Rochester, N.Y. “In small and solo practices, the provider usually has all of the burden.”
Dr. Mendelson is not of the opinion that extra documentation will add value to the patient.
“It’s possible that this precision will better capture acuity and therefore risk of morbidity and mortality, so the provider gets a better expected to observed morbidity and mortality ratio, and thus better ratings on quality metrics” he concedes, but he has his doubts. “This has some potential for better reimbursement and thus an improved reputation, but can also backfire.”
The reason for this, Dr. Mendelson says, comes down to how motivated to excel physicians are at using the new codes.
“Most of us focus on adequate documentation to communicate with each other and provide good, safe, thoughtful care and not on compliance or reimbursement issues that don’t seem to provide better safety, quality, cost, or value to patients or us,” he noted.
Coding and physician reputation
The connection between precise coding and improved physician reimbursement cannot be the sole justification for a clinical documentation initiative, both Dr. Oliva and Dr. Mendelson agree.
“I really believe that with physicians, reputation matters more,”says Dr. Oliva. Or put another way, even if you hate ICD-10, administrators are banking that your ego will triumph over your disdain for the new codes.
Because billing is determined by how well coded – and documented – each patient visit is, if the costs associated with your patients don’t add up to what the codes on them indicate they should, your reputation could suffer – and not just with hospital bean counters, but with the public at large.
Online physician rating sites are powered by data on every patient treated by every physician in the Centers for Medicare & Medicaid Services system, purchased from CMS each November, says Dr. Oliva. The more disconnects between physician documentation and coding, the lower a physician’s ratings in the data shared with the public.
“We come from a culture of being very competitive our entire lives, and never having failed, and all of a sudden we’re talking about objective performance and score cards,” Dr. Oliva said. “Physicians don’t know where this is all coming from because it’s not something that’s been done before, and they don’t know how to impact it.” The solution, he says, is to just do what you were trained to do: Note something with specificity. “Take a breath. Relax. It’s manageable for you as a physician.”
Dr. Mendelson, also his institution’s palliative care director and geriatric fracture center codirector, is not quite as optimistic. “Coding the above scenario correctly does not change anything clinically,” he says. “The way the note is written and the care executed tells the story way more than the coding.”
Dr. Mendelson worries that hyperspecific documentation “might actually destroy some of the nuance and make it more difficult to clearly communicate to other providers, let alone be clear for our own purposes.”
Finding the middle ground between the needs of physicians and administrators might come down to how CMS deals with the ICD-10 transition. Talk of a government shutdown aside, the Obama Administration has assured the public that it is committed to helping physicians and other providers transition smoothly to the new system.
“There will be some early flexibility on ICD-10 from what I understand, and an attempt to make it softer for physicians,” says Dr. Mendelson.
Dr. Oliva is CMO and a consultant at Nuance Communications and Dr. Mendelson had no relevant conflicts of interest.
On Twitter @whitneymcknight
Physicians’ fears of handling the transition to ICD-10 are likely not rooted in reality, especially in the hospital setting, industry experts say.
“There are just a few things physicians need to learn how to do that they’re not doing already, and they will learn pretty quickly,” said Dr. Anthony Oliva, vice president and chief medical officer of the health division of Nuance Communications, a Boston-based consulting firm, in an interview. Previously, Dr. Oliva was chief medical officer for the Borgess Health in Kalamazoo, Mich.
Dr. Oliva cites as an example a patient with a history of heart failure. In addition to noting that he has a history of cardiomyopathy secondary to ischemia and a history of decreased left ventricular function, a provider also must indicate that the patient has “chronic systolic failure,” according to Dr. Oliva, who says that failing to add these three words could mean not aligning with the diagnostic group logic being used in the ICD-10 code set, and thus not being reimbursed accordingly.
Although physicians might roll their eyes at this, Dr. Oliva, himself a family practice physician, says it’s better than having to memorize “a zillion” code combinations. “The majority of what we see is hypertension, diabetes, some kidney disease, and some GI disease, so you can just pare down what you have to know, and what you have to document. It becomes manageable. It’s more about documenting than it is about coding,” says Dr. Oliva. For specialists, it’s even easier he says, since they need only know a narrow swathe of the more than 70,000 ICD-10 codes. Dr. Oliva says that in time, health system coders likely will reveal to physicians the codes they must know for the documentation they are doing most often.
“In bigger practices with coding support, it will be the coders working with their providers to get the precision,” says Dr. Daniel Ari Mendelson, an associate chief of medicine at Highland Hospital in Rochester, N.Y. “In small and solo practices, the provider usually has all of the burden.”
Dr. Mendelson is not of the opinion that extra documentation will add value to the patient.
“It’s possible that this precision will better capture acuity and therefore risk of morbidity and mortality, so the provider gets a better expected to observed morbidity and mortality ratio, and thus better ratings on quality metrics” he concedes, but he has his doubts. “This has some potential for better reimbursement and thus an improved reputation, but can also backfire.”
The reason for this, Dr. Mendelson says, comes down to how motivated to excel physicians are at using the new codes.
“Most of us focus on adequate documentation to communicate with each other and provide good, safe, thoughtful care and not on compliance or reimbursement issues that don’t seem to provide better safety, quality, cost, or value to patients or us,” he noted.
Coding and physician reputation
The connection between precise coding and improved physician reimbursement cannot be the sole justification for a clinical documentation initiative, both Dr. Oliva and Dr. Mendelson agree.
“I really believe that with physicians, reputation matters more,”says Dr. Oliva. Or put another way, even if you hate ICD-10, administrators are banking that your ego will triumph over your disdain for the new codes.
Because billing is determined by how well coded – and documented – each patient visit is, if the costs associated with your patients don’t add up to what the codes on them indicate they should, your reputation could suffer – and not just with hospital bean counters, but with the public at large.
Online physician rating sites are powered by data on every patient treated by every physician in the Centers for Medicare & Medicaid Services system, purchased from CMS each November, says Dr. Oliva. The more disconnects between physician documentation and coding, the lower a physician’s ratings in the data shared with the public.
“We come from a culture of being very competitive our entire lives, and never having failed, and all of a sudden we’re talking about objective performance and score cards,” Dr. Oliva said. “Physicians don’t know where this is all coming from because it’s not something that’s been done before, and they don’t know how to impact it.” The solution, he says, is to just do what you were trained to do: Note something with specificity. “Take a breath. Relax. It’s manageable for you as a physician.”
Dr. Mendelson, also his institution’s palliative care director and geriatric fracture center codirector, is not quite as optimistic. “Coding the above scenario correctly does not change anything clinically,” he says. “The way the note is written and the care executed tells the story way more than the coding.”
Dr. Mendelson worries that hyperspecific documentation “might actually destroy some of the nuance and make it more difficult to clearly communicate to other providers, let alone be clear for our own purposes.”
Finding the middle ground between the needs of physicians and administrators might come down to how CMS deals with the ICD-10 transition. Talk of a government shutdown aside, the Obama Administration has assured the public that it is committed to helping physicians and other providers transition smoothly to the new system.
“There will be some early flexibility on ICD-10 from what I understand, and an attempt to make it softer for physicians,” says Dr. Mendelson.
Dr. Oliva is CMO and a consultant at Nuance Communications and Dr. Mendelson had no relevant conflicts of interest.
On Twitter @whitneymcknight
Physicians’ fears of handling the transition to ICD-10 are likely not rooted in reality, especially in the hospital setting, industry experts say.
“There are just a few things physicians need to learn how to do that they’re not doing already, and they will learn pretty quickly,” said Dr. Anthony Oliva, vice president and chief medical officer of the health division of Nuance Communications, a Boston-based consulting firm, in an interview. Previously, Dr. Oliva was chief medical officer for the Borgess Health in Kalamazoo, Mich.
Dr. Oliva cites as an example a patient with a history of heart failure. In addition to noting that he has a history of cardiomyopathy secondary to ischemia and a history of decreased left ventricular function, a provider also must indicate that the patient has “chronic systolic failure,” according to Dr. Oliva, who says that failing to add these three words could mean not aligning with the diagnostic group logic being used in the ICD-10 code set, and thus not being reimbursed accordingly.
Although physicians might roll their eyes at this, Dr. Oliva, himself a family practice physician, says it’s better than having to memorize “a zillion” code combinations. “The majority of what we see is hypertension, diabetes, some kidney disease, and some GI disease, so you can just pare down what you have to know, and what you have to document. It becomes manageable. It’s more about documenting than it is about coding,” says Dr. Oliva. For specialists, it’s even easier he says, since they need only know a narrow swathe of the more than 70,000 ICD-10 codes. Dr. Oliva says that in time, health system coders likely will reveal to physicians the codes they must know for the documentation they are doing most often.
“In bigger practices with coding support, it will be the coders working with their providers to get the precision,” says Dr. Daniel Ari Mendelson, an associate chief of medicine at Highland Hospital in Rochester, N.Y. “In small and solo practices, the provider usually has all of the burden.”
Dr. Mendelson is not of the opinion that extra documentation will add value to the patient.
“It’s possible that this precision will better capture acuity and therefore risk of morbidity and mortality, so the provider gets a better expected to observed morbidity and mortality ratio, and thus better ratings on quality metrics” he concedes, but he has his doubts. “This has some potential for better reimbursement and thus an improved reputation, but can also backfire.”
The reason for this, Dr. Mendelson says, comes down to how motivated to excel physicians are at using the new codes.
“Most of us focus on adequate documentation to communicate with each other and provide good, safe, thoughtful care and not on compliance or reimbursement issues that don’t seem to provide better safety, quality, cost, or value to patients or us,” he noted.
Coding and physician reputation
The connection between precise coding and improved physician reimbursement cannot be the sole justification for a clinical documentation initiative, both Dr. Oliva and Dr. Mendelson agree.
“I really believe that with physicians, reputation matters more,”says Dr. Oliva. Or put another way, even if you hate ICD-10, administrators are banking that your ego will triumph over your disdain for the new codes.
Because billing is determined by how well coded – and documented – each patient visit is, if the costs associated with your patients don’t add up to what the codes on them indicate they should, your reputation could suffer – and not just with hospital bean counters, but with the public at large.
Online physician rating sites are powered by data on every patient treated by every physician in the Centers for Medicare & Medicaid Services system, purchased from CMS each November, says Dr. Oliva. The more disconnects between physician documentation and coding, the lower a physician’s ratings in the data shared with the public.
“We come from a culture of being very competitive our entire lives, and never having failed, and all of a sudden we’re talking about objective performance and score cards,” Dr. Oliva said. “Physicians don’t know where this is all coming from because it’s not something that’s been done before, and they don’t know how to impact it.” The solution, he says, is to just do what you were trained to do: Note something with specificity. “Take a breath. Relax. It’s manageable for you as a physician.”
Dr. Mendelson, also his institution’s palliative care director and geriatric fracture center codirector, is not quite as optimistic. “Coding the above scenario correctly does not change anything clinically,” he says. “The way the note is written and the care executed tells the story way more than the coding.”
Dr. Mendelson worries that hyperspecific documentation “might actually destroy some of the nuance and make it more difficult to clearly communicate to other providers, let alone be clear for our own purposes.”
Finding the middle ground between the needs of physicians and administrators might come down to how CMS deals with the ICD-10 transition. Talk of a government shutdown aside, the Obama Administration has assured the public that it is committed to helping physicians and other providers transition smoothly to the new system.
“There will be some early flexibility on ICD-10 from what I understand, and an attempt to make it softer for physicians,” says Dr. Mendelson.
Dr. Oliva is CMO and a consultant at Nuance Communications and Dr. Mendelson had no relevant conflicts of interest.
On Twitter @whitneymcknight
Evidence links common endocrine-disrupting chemicals to obesity, diabetes, reproductive disorders
Cash register receipts, tin can linings, and a range of cosmetics and other common household products increasingly are implicated in the most intractable of society’s diseases such as obesity and diabetes.
So-called endocrine-disrupting chemicals have become so common, according to the Washington-based Endocrine Society, that nearly every human alive has been exposed to at least one such chemical, probably more than once, and just as likely, over an extended period of time.
The World Health Organization reports that there are more than 800 known endocrine disrupting chemicals (EDCs) used in products globally, but only a fraction of them have been tested in humans. What effects, if any, this exposure is having on individuals is still unknown, but data linking the ability of EDCs – either singularly or in combination – to mimic, block, or otherwise interfere with the body’s natural hormone signaling has some experts sounding the alarm.
“The evidence is more definitive than ever before – EDCs disrupt hormones in a manner that harms human health,” Andrea C. Gore, Ph.D., a pharmacology professor at the University of Texas at Austin, said in a press conference. Dr. Gore chairs the Endocrine Society task force that recently released an executive summary of its second scientific statement on EDCs. The Society presented the statement, an update of one released in 2009, at this year’s International Conference on Chemicals Management annual meeting in Geneva.
Because the endocrine system’s role is to interact with the environment, it is predisposed to react to triggers increasingly found in everything from pesticides to shower curtains, which have now made their way into waterways and the food chain primarily without any studies on their impact. “Both natural hormones and EDCs have unique dose-response properties [and can] act at very-low doses,” Dr. Gore told reporters. “We’re exposed throughout our lives.”
The use of EDCs largely began post-WWII with pesticides such as DDT (dichlorodiphenyltrichloroethane), but over time came to include use as thickeners, plastic softeners, and scent in many common household items. Dr. Gore told a reporter that even though these chemicals were not intended to enter the environment at large, decades of use has made their entry into the food chain inevitable. The population health effects of this are only now becoming evident as data accumulate linking EDCs to a constellation of ill health effects.
“In humans, there are strong epidemiological associations between EDCs and chronic diseases.” Dr. Gore said.
She specifically cited obesity, diabetes, and a range of reproductive disorders, including infertility and certain hormone-related cancers. Research also shows a link between prenatal EDC exposure in animals to obesity, insulin resistance, and overabundant insulin later in life.
The Society’s meta-analysis of more than 1,300 studies published in the last 5 years also implicated EDCs in disorders of the prostate gland, the thyroid, and the neuroendocrine systems, the latter two being particularly vulnerable because of their role in hormone regulation at all stages of development.
“We’re particularly concerned about fetuses and how exposure can set the stage for later development of diseases,” Dr. Gore said, noting that human studies have shown a link between higher EDC exposures over time and cognitive deficits and other adverse neurocognitive outcomes.
Because the effect of EDC exposure differs according to the dose, length, and timing of exposure, designing studies to measure any harm has been difficult, said Dr. Gore, although in the past 5 years, there has been increased insight into the molecular mechanisms underlying EDCs.
Among the most common EDCs are bisphenol A (BPA) and phthalates, synthetic chemicals that bind to hormone receptors and depending upon the dose, either potentiate, inhibit – or both – the hormone’s effect on receptors. These EDCs frequently occur in toys, bottle nipples, rain coats, shower curtains, and in medical supplies such as blood bags, IV tubing, and catheters.
Initially registered as a pesticide, the EDC triclosan’s antimicrobial power has meant it is now used in deodorants and even in toothpaste. Triclosan has been shown to disrupt the thyroid, and to have antiestrogenic, and antiandrogenic properties. It also has been linked to asthma.
Plastic water bottles and disposable, plastic-based food packaging commonly found in microwaveable products often are high in BPAs, according to Dr. Gore, who urged all primary care physicians to counsel patients on the importance of avoiding products that contain them whenever possible, particularly in cases of pediatric obesity or diabetes, and for patients who are pregnant or in the family-planning stages. “You might not see an adverse outcome until years or decades later.”
Because many EDCs are lipophilic, our bodies often store them in our fat cells, often for years at a time.
While bisphenol A tends to exit the body quickly, we are commonly exposed to it on a daily basis, usually through a compound that leaches into our food, allowing the chemical an opportunity to exert an effect, even if the results of this effect aren’t immediately apparent. “If it’s a pregnant woman or someone planning a family, that exposure can change something,” Dr. Gore warned.
Although earlier studies had linked EDC exposure to a variety of reproductive health concerns, Dr. Gore said that since the Society’s last statement, there is much more corroborating evidence. In particular, polycystic ovarian syndrome in humans has been associated with higher body burdens of BPA and other chemicals, as have endometriosis, fibroids, and some adverse birth outcomes. Still, much of the data come from animal studies, and studies of specific links between EDCs and reproductive outcomes and cancers are inconsistent.
According to Dr. Renee Howard, a pediatric dermatologist with Sutter Health in San Francisco, who regularly gives presentations on the effects of EDCs in cosmetics and other skin care products, although much of the current research shows a link between EDCs and chronic illness, so far a causal relationship has not been established. Still, she said she routinely tells other physicians to keep an “open mind” when discussing EDCs with patients.
“We can acknowledge there is uncertainty, and we can tell patients that these chemicals are actively being studied, but that the studies are, as of now, inconclusive, and that there are still no documented adverse health effects associated with skin care products,” Dr. Howard said. Nevertheless, she said common sense dictates her to counsel patients to avoid products containing the EDC triclosan such as antimicrobials and scented products. She also advises them to eat organic produce in order to avoid pesticides.
Dr. Gore and her coauthors hope the statement will help bump EDC oversight higher up the policy chain globally.
“Exposure to endocrine disrupting chemicals during early development can have long-lasting, even permanent consequences,” Endocrine Society member Dr. Jean-Pierre Bourguignon, a professor of pediatric endocrinology at the University of Liège in Belgium, said in a statement. “The science is clear, and it’s time for policy makers to take this wealth of evidence into account as they develop legislation.”
To that end, earlier this year, twin bills are now before the House and Senate, which – if passed – will take effect in 2018, banning the sale of any personal care products containing microbeads, BPA-rich, microscopic plastic particles that have entered much of the natural water supply, threatening marine life which often mistake the tiny bits as food. Meanwhile, Minnesota has banned the use of triclosan statewide as of 2017.
Dr. Gore also said in addition to funding for this research being made a priority, it’s time to rethink who gets to be in on the science. Rather than just industrial chemists, she believes the teams should include so-called “green chemists,” basic, translational, and clinical scientists; epidemiologists, as well as public health professionals. Health care providers should be familiar with endocrine science and the latest developments in EDC research, accordingly, because, said Dr. Gore, “The [health] costs of EDCs have been estimated in the hundreds of millions of dollars. Prevention might seem expensive, but it’s far-less-expensive than all the ensuing diseases.”
Most of all, Dr. Gore and her colleagues emphasize that there will never be “absolute proof” of anything, but that taking action to stem exposure is essential.
The analysis was sponsored by the Endocrine Society. Dr. Gore is editor in chief of Endocrinology. Dr. Howard disclosed no relevant financial relationships.
On Twitter @whitneymcknight
Cash register receipts, tin can linings, and a range of cosmetics and other common household products increasingly are implicated in the most intractable of society’s diseases such as obesity and diabetes.
So-called endocrine-disrupting chemicals have become so common, according to the Washington-based Endocrine Society, that nearly every human alive has been exposed to at least one such chemical, probably more than once, and just as likely, over an extended period of time.
The World Health Organization reports that there are more than 800 known endocrine disrupting chemicals (EDCs) used in products globally, but only a fraction of them have been tested in humans. What effects, if any, this exposure is having on individuals is still unknown, but data linking the ability of EDCs – either singularly or in combination – to mimic, block, or otherwise interfere with the body’s natural hormone signaling has some experts sounding the alarm.
“The evidence is more definitive than ever before – EDCs disrupt hormones in a manner that harms human health,” Andrea C. Gore, Ph.D., a pharmacology professor at the University of Texas at Austin, said in a press conference. Dr. Gore chairs the Endocrine Society task force that recently released an executive summary of its second scientific statement on EDCs. The Society presented the statement, an update of one released in 2009, at this year’s International Conference on Chemicals Management annual meeting in Geneva.
Because the endocrine system’s role is to interact with the environment, it is predisposed to react to triggers increasingly found in everything from pesticides to shower curtains, which have now made their way into waterways and the food chain primarily without any studies on their impact. “Both natural hormones and EDCs have unique dose-response properties [and can] act at very-low doses,” Dr. Gore told reporters. “We’re exposed throughout our lives.”
The use of EDCs largely began post-WWII with pesticides such as DDT (dichlorodiphenyltrichloroethane), but over time came to include use as thickeners, plastic softeners, and scent in many common household items. Dr. Gore told a reporter that even though these chemicals were not intended to enter the environment at large, decades of use has made their entry into the food chain inevitable. The population health effects of this are only now becoming evident as data accumulate linking EDCs to a constellation of ill health effects.
“In humans, there are strong epidemiological associations between EDCs and chronic diseases.” Dr. Gore said.
She specifically cited obesity, diabetes, and a range of reproductive disorders, including infertility and certain hormone-related cancers. Research also shows a link between prenatal EDC exposure in animals to obesity, insulin resistance, and overabundant insulin later in life.
The Society’s meta-analysis of more than 1,300 studies published in the last 5 years also implicated EDCs in disorders of the prostate gland, the thyroid, and the neuroendocrine systems, the latter two being particularly vulnerable because of their role in hormone regulation at all stages of development.
“We’re particularly concerned about fetuses and how exposure can set the stage for later development of diseases,” Dr. Gore said, noting that human studies have shown a link between higher EDC exposures over time and cognitive deficits and other adverse neurocognitive outcomes.
Because the effect of EDC exposure differs according to the dose, length, and timing of exposure, designing studies to measure any harm has been difficult, said Dr. Gore, although in the past 5 years, there has been increased insight into the molecular mechanisms underlying EDCs.
Among the most common EDCs are bisphenol A (BPA) and phthalates, synthetic chemicals that bind to hormone receptors and depending upon the dose, either potentiate, inhibit – or both – the hormone’s effect on receptors. These EDCs frequently occur in toys, bottle nipples, rain coats, shower curtains, and in medical supplies such as blood bags, IV tubing, and catheters.
Initially registered as a pesticide, the EDC triclosan’s antimicrobial power has meant it is now used in deodorants and even in toothpaste. Triclosan has been shown to disrupt the thyroid, and to have antiestrogenic, and antiandrogenic properties. It also has been linked to asthma.
Plastic water bottles and disposable, plastic-based food packaging commonly found in microwaveable products often are high in BPAs, according to Dr. Gore, who urged all primary care physicians to counsel patients on the importance of avoiding products that contain them whenever possible, particularly in cases of pediatric obesity or diabetes, and for patients who are pregnant or in the family-planning stages. “You might not see an adverse outcome until years or decades later.”
Because many EDCs are lipophilic, our bodies often store them in our fat cells, often for years at a time.
While bisphenol A tends to exit the body quickly, we are commonly exposed to it on a daily basis, usually through a compound that leaches into our food, allowing the chemical an opportunity to exert an effect, even if the results of this effect aren’t immediately apparent. “If it’s a pregnant woman or someone planning a family, that exposure can change something,” Dr. Gore warned.
Although earlier studies had linked EDC exposure to a variety of reproductive health concerns, Dr. Gore said that since the Society’s last statement, there is much more corroborating evidence. In particular, polycystic ovarian syndrome in humans has been associated with higher body burdens of BPA and other chemicals, as have endometriosis, fibroids, and some adverse birth outcomes. Still, much of the data come from animal studies, and studies of specific links between EDCs and reproductive outcomes and cancers are inconsistent.
According to Dr. Renee Howard, a pediatric dermatologist with Sutter Health in San Francisco, who regularly gives presentations on the effects of EDCs in cosmetics and other skin care products, although much of the current research shows a link between EDCs and chronic illness, so far a causal relationship has not been established. Still, she said she routinely tells other physicians to keep an “open mind” when discussing EDCs with patients.
“We can acknowledge there is uncertainty, and we can tell patients that these chemicals are actively being studied, but that the studies are, as of now, inconclusive, and that there are still no documented adverse health effects associated with skin care products,” Dr. Howard said. Nevertheless, she said common sense dictates her to counsel patients to avoid products containing the EDC triclosan such as antimicrobials and scented products. She also advises them to eat organic produce in order to avoid pesticides.
Dr. Gore and her coauthors hope the statement will help bump EDC oversight higher up the policy chain globally.
“Exposure to endocrine disrupting chemicals during early development can have long-lasting, even permanent consequences,” Endocrine Society member Dr. Jean-Pierre Bourguignon, a professor of pediatric endocrinology at the University of Liège in Belgium, said in a statement. “The science is clear, and it’s time for policy makers to take this wealth of evidence into account as they develop legislation.”
To that end, earlier this year, twin bills are now before the House and Senate, which – if passed – will take effect in 2018, banning the sale of any personal care products containing microbeads, BPA-rich, microscopic plastic particles that have entered much of the natural water supply, threatening marine life which often mistake the tiny bits as food. Meanwhile, Minnesota has banned the use of triclosan statewide as of 2017.
Dr. Gore also said in addition to funding for this research being made a priority, it’s time to rethink who gets to be in on the science. Rather than just industrial chemists, she believes the teams should include so-called “green chemists,” basic, translational, and clinical scientists; epidemiologists, as well as public health professionals. Health care providers should be familiar with endocrine science and the latest developments in EDC research, accordingly, because, said Dr. Gore, “The [health] costs of EDCs have been estimated in the hundreds of millions of dollars. Prevention might seem expensive, but it’s far-less-expensive than all the ensuing diseases.”
Most of all, Dr. Gore and her colleagues emphasize that there will never be “absolute proof” of anything, but that taking action to stem exposure is essential.
The analysis was sponsored by the Endocrine Society. Dr. Gore is editor in chief of Endocrinology. Dr. Howard disclosed no relevant financial relationships.
On Twitter @whitneymcknight
Cash register receipts, tin can linings, and a range of cosmetics and other common household products increasingly are implicated in the most intractable of society’s diseases such as obesity and diabetes.
So-called endocrine-disrupting chemicals have become so common, according to the Washington-based Endocrine Society, that nearly every human alive has been exposed to at least one such chemical, probably more than once, and just as likely, over an extended period of time.
The World Health Organization reports that there are more than 800 known endocrine disrupting chemicals (EDCs) used in products globally, but only a fraction of them have been tested in humans. What effects, if any, this exposure is having on individuals is still unknown, but data linking the ability of EDCs – either singularly or in combination – to mimic, block, or otherwise interfere with the body’s natural hormone signaling has some experts sounding the alarm.
“The evidence is more definitive than ever before – EDCs disrupt hormones in a manner that harms human health,” Andrea C. Gore, Ph.D., a pharmacology professor at the University of Texas at Austin, said in a press conference. Dr. Gore chairs the Endocrine Society task force that recently released an executive summary of its second scientific statement on EDCs. The Society presented the statement, an update of one released in 2009, at this year’s International Conference on Chemicals Management annual meeting in Geneva.
Because the endocrine system’s role is to interact with the environment, it is predisposed to react to triggers increasingly found in everything from pesticides to shower curtains, which have now made their way into waterways and the food chain primarily without any studies on their impact. “Both natural hormones and EDCs have unique dose-response properties [and can] act at very-low doses,” Dr. Gore told reporters. “We’re exposed throughout our lives.”
The use of EDCs largely began post-WWII with pesticides such as DDT (dichlorodiphenyltrichloroethane), but over time came to include use as thickeners, plastic softeners, and scent in many common household items. Dr. Gore told a reporter that even though these chemicals were not intended to enter the environment at large, decades of use has made their entry into the food chain inevitable. The population health effects of this are only now becoming evident as data accumulate linking EDCs to a constellation of ill health effects.
“In humans, there are strong epidemiological associations between EDCs and chronic diseases.” Dr. Gore said.
She specifically cited obesity, diabetes, and a range of reproductive disorders, including infertility and certain hormone-related cancers. Research also shows a link between prenatal EDC exposure in animals to obesity, insulin resistance, and overabundant insulin later in life.
The Society’s meta-analysis of more than 1,300 studies published in the last 5 years also implicated EDCs in disorders of the prostate gland, the thyroid, and the neuroendocrine systems, the latter two being particularly vulnerable because of their role in hormone regulation at all stages of development.
“We’re particularly concerned about fetuses and how exposure can set the stage for later development of diseases,” Dr. Gore said, noting that human studies have shown a link between higher EDC exposures over time and cognitive deficits and other adverse neurocognitive outcomes.
Because the effect of EDC exposure differs according to the dose, length, and timing of exposure, designing studies to measure any harm has been difficult, said Dr. Gore, although in the past 5 years, there has been increased insight into the molecular mechanisms underlying EDCs.
Among the most common EDCs are bisphenol A (BPA) and phthalates, synthetic chemicals that bind to hormone receptors and depending upon the dose, either potentiate, inhibit – or both – the hormone’s effect on receptors. These EDCs frequently occur in toys, bottle nipples, rain coats, shower curtains, and in medical supplies such as blood bags, IV tubing, and catheters.
Initially registered as a pesticide, the EDC triclosan’s antimicrobial power has meant it is now used in deodorants and even in toothpaste. Triclosan has been shown to disrupt the thyroid, and to have antiestrogenic, and antiandrogenic properties. It also has been linked to asthma.
Plastic water bottles and disposable, plastic-based food packaging commonly found in microwaveable products often are high in BPAs, according to Dr. Gore, who urged all primary care physicians to counsel patients on the importance of avoiding products that contain them whenever possible, particularly in cases of pediatric obesity or diabetes, and for patients who are pregnant or in the family-planning stages. “You might not see an adverse outcome until years or decades later.”
Because many EDCs are lipophilic, our bodies often store them in our fat cells, often for years at a time.
While bisphenol A tends to exit the body quickly, we are commonly exposed to it on a daily basis, usually through a compound that leaches into our food, allowing the chemical an opportunity to exert an effect, even if the results of this effect aren’t immediately apparent. “If it’s a pregnant woman or someone planning a family, that exposure can change something,” Dr. Gore warned.
Although earlier studies had linked EDC exposure to a variety of reproductive health concerns, Dr. Gore said that since the Society’s last statement, there is much more corroborating evidence. In particular, polycystic ovarian syndrome in humans has been associated with higher body burdens of BPA and other chemicals, as have endometriosis, fibroids, and some adverse birth outcomes. Still, much of the data come from animal studies, and studies of specific links between EDCs and reproductive outcomes and cancers are inconsistent.
According to Dr. Renee Howard, a pediatric dermatologist with Sutter Health in San Francisco, who regularly gives presentations on the effects of EDCs in cosmetics and other skin care products, although much of the current research shows a link between EDCs and chronic illness, so far a causal relationship has not been established. Still, she said she routinely tells other physicians to keep an “open mind” when discussing EDCs with patients.
“We can acknowledge there is uncertainty, and we can tell patients that these chemicals are actively being studied, but that the studies are, as of now, inconclusive, and that there are still no documented adverse health effects associated with skin care products,” Dr. Howard said. Nevertheless, she said common sense dictates her to counsel patients to avoid products containing the EDC triclosan such as antimicrobials and scented products. She also advises them to eat organic produce in order to avoid pesticides.
Dr. Gore and her coauthors hope the statement will help bump EDC oversight higher up the policy chain globally.
“Exposure to endocrine disrupting chemicals during early development can have long-lasting, even permanent consequences,” Endocrine Society member Dr. Jean-Pierre Bourguignon, a professor of pediatric endocrinology at the University of Liège in Belgium, said in a statement. “The science is clear, and it’s time for policy makers to take this wealth of evidence into account as they develop legislation.”
To that end, earlier this year, twin bills are now before the House and Senate, which – if passed – will take effect in 2018, banning the sale of any personal care products containing microbeads, BPA-rich, microscopic plastic particles that have entered much of the natural water supply, threatening marine life which often mistake the tiny bits as food. Meanwhile, Minnesota has banned the use of triclosan statewide as of 2017.
Dr. Gore also said in addition to funding for this research being made a priority, it’s time to rethink who gets to be in on the science. Rather than just industrial chemists, she believes the teams should include so-called “green chemists,” basic, translational, and clinical scientists; epidemiologists, as well as public health professionals. Health care providers should be familiar with endocrine science and the latest developments in EDC research, accordingly, because, said Dr. Gore, “The [health] costs of EDCs have been estimated in the hundreds of millions of dollars. Prevention might seem expensive, but it’s far-less-expensive than all the ensuing diseases.”
Most of all, Dr. Gore and her colleagues emphasize that there will never be “absolute proof” of anything, but that taking action to stem exposure is essential.
The analysis was sponsored by the Endocrine Society. Dr. Gore is editor in chief of Endocrinology. Dr. Howard disclosed no relevant financial relationships.
On Twitter @whitneymcknight
Use team care to take advantage of Medicare chronic care fee
To make the most of the Medicare chronic care management (CCM) payment, have a nurse or other nonphysician provider deliver the care.
That was the conclusion reached by Dr. Sanjay Basu of Stanford (Calif.) University and his colleagues based on their analysis of national practice data on patient use of primary care services, staffing costs, overhead, and reimbursements, published Sept. 21 in Annals of Internal Medicine (doi:10.7326/M14-2677).
Up to two-thirds of Medicare-covered patients on primary care patient panels are eligible for the new CCM payment, unveiled earlier this year as part of Medicare’s move away from fee-for-service medicine, according to the researchers.
Dr. Basu and his colleagues created microsimulation models to determine that net revenue gains were highest when CCM plans were developed at an annual preventive care visit and in partnership with nonphysician providers who were then tasked with delivering the care.
If services were delivered by a registered nurse, revenue increased $332/CCM patient. When delivered by a licensed practical nurse, the increase was $372/CCM patient. And when a medical assistent delivered the care, revenue increased by $385/CCM patient.
For primary care practices with patient panels of about 2,000, if a minimum of 76 CCM patients per full-time equivalent physician were enrolled and cared for by a registered nurse, the net annual revenue increase was $75,000 per full-time physician when combined with the cost of 12 hours of weekly nursing services.
The analysis could incentivize practices to adapt more team-based models of care, regardless of practice size, Dr. Basu noted.
On Twitter @whitneymcknight
Despite the analysis conducted by Dr. Basu and his colleagues, Medicare reimbursements for chronic care costs are still too vague to bank on such large estimated gains.
The $8-per-month CCM copayment may not be covered by insurance because many plans do not cover out-of-visit services. Patients may decline to pay for a service they do not see, believing that they already have their care coordinated. And because CCM is not limited to primary care, patients might also be unwilling to exclude their specialists from their care plans, because of a fear of losing access to them.
Because team-based models of CCM often require data sharing, the cost of electronic health records must also be factored into cost/revenue ratios, particularly since many EHR data systems still prevent successful information transfers, despite federal laws requiring interoperability.
If interoperability were truly effective and primary care providers had easy access to the data across systems required for care coordination, we might not have to hire other providers to do a job that has traditionally been ours alone.
Dr. Fitzhugh C. Pannill III is an internist at the University of Connecticut in Farmington. His comments were made in an editorial accompanying Dr. Basu’s report.
Despite the analysis conducted by Dr. Basu and his colleagues, Medicare reimbursements for chronic care costs are still too vague to bank on such large estimated gains.
The $8-per-month CCM copayment may not be covered by insurance because many plans do not cover out-of-visit services. Patients may decline to pay for a service they do not see, believing that they already have their care coordinated. And because CCM is not limited to primary care, patients might also be unwilling to exclude their specialists from their care plans, because of a fear of losing access to them.
Because team-based models of CCM often require data sharing, the cost of electronic health records must also be factored into cost/revenue ratios, particularly since many EHR data systems still prevent successful information transfers, despite federal laws requiring interoperability.
If interoperability were truly effective and primary care providers had easy access to the data across systems required for care coordination, we might not have to hire other providers to do a job that has traditionally been ours alone.
Dr. Fitzhugh C. Pannill III is an internist at the University of Connecticut in Farmington. His comments were made in an editorial accompanying Dr. Basu’s report.
Despite the analysis conducted by Dr. Basu and his colleagues, Medicare reimbursements for chronic care costs are still too vague to bank on such large estimated gains.
The $8-per-month CCM copayment may not be covered by insurance because many plans do not cover out-of-visit services. Patients may decline to pay for a service they do not see, believing that they already have their care coordinated. And because CCM is not limited to primary care, patients might also be unwilling to exclude their specialists from their care plans, because of a fear of losing access to them.
Because team-based models of CCM often require data sharing, the cost of electronic health records must also be factored into cost/revenue ratios, particularly since many EHR data systems still prevent successful information transfers, despite federal laws requiring interoperability.
If interoperability were truly effective and primary care providers had easy access to the data across systems required for care coordination, we might not have to hire other providers to do a job that has traditionally been ours alone.
Dr. Fitzhugh C. Pannill III is an internist at the University of Connecticut in Farmington. His comments were made in an editorial accompanying Dr. Basu’s report.
To make the most of the Medicare chronic care management (CCM) payment, have a nurse or other nonphysician provider deliver the care.
That was the conclusion reached by Dr. Sanjay Basu of Stanford (Calif.) University and his colleagues based on their analysis of national practice data on patient use of primary care services, staffing costs, overhead, and reimbursements, published Sept. 21 in Annals of Internal Medicine (doi:10.7326/M14-2677).
Up to two-thirds of Medicare-covered patients on primary care patient panels are eligible for the new CCM payment, unveiled earlier this year as part of Medicare’s move away from fee-for-service medicine, according to the researchers.
Dr. Basu and his colleagues created microsimulation models to determine that net revenue gains were highest when CCM plans were developed at an annual preventive care visit and in partnership with nonphysician providers who were then tasked with delivering the care.
If services were delivered by a registered nurse, revenue increased $332/CCM patient. When delivered by a licensed practical nurse, the increase was $372/CCM patient. And when a medical assistent delivered the care, revenue increased by $385/CCM patient.
For primary care practices with patient panels of about 2,000, if a minimum of 76 CCM patients per full-time equivalent physician were enrolled and cared for by a registered nurse, the net annual revenue increase was $75,000 per full-time physician when combined with the cost of 12 hours of weekly nursing services.
The analysis could incentivize practices to adapt more team-based models of care, regardless of practice size, Dr. Basu noted.
On Twitter @whitneymcknight
To make the most of the Medicare chronic care management (CCM) payment, have a nurse or other nonphysician provider deliver the care.
That was the conclusion reached by Dr. Sanjay Basu of Stanford (Calif.) University and his colleagues based on their analysis of national practice data on patient use of primary care services, staffing costs, overhead, and reimbursements, published Sept. 21 in Annals of Internal Medicine (doi:10.7326/M14-2677).
Up to two-thirds of Medicare-covered patients on primary care patient panels are eligible for the new CCM payment, unveiled earlier this year as part of Medicare’s move away from fee-for-service medicine, according to the researchers.
Dr. Basu and his colleagues created microsimulation models to determine that net revenue gains were highest when CCM plans were developed at an annual preventive care visit and in partnership with nonphysician providers who were then tasked with delivering the care.
If services were delivered by a registered nurse, revenue increased $332/CCM patient. When delivered by a licensed practical nurse, the increase was $372/CCM patient. And when a medical assistent delivered the care, revenue increased by $385/CCM patient.
For primary care practices with patient panels of about 2,000, if a minimum of 76 CCM patients per full-time equivalent physician were enrolled and cared for by a registered nurse, the net annual revenue increase was $75,000 per full-time physician when combined with the cost of 12 hours of weekly nursing services.
The analysis could incentivize practices to adapt more team-based models of care, regardless of practice size, Dr. Basu noted.
On Twitter @whitneymcknight
FROM ANNALS OF INTERNAL MEDICINE
Key clinical point: Hiring sufficient numbers of non-physician staff to manage chronic care patients can increase revenues.
Major finding: Net $75,000 annual revenue increase per full-time physician, combined with 12 hours of weekly nursing services, per 76 chronic care patients in a 2,000-patient panel.
Data source: Microsimulation models based on analysis of national practice data.
Disclosures: Dr. Asaf Bitton, a coauthor on the study, was senior adviser to the Centers for Medicare & Medicaid Innovation for the Comprehensive Primary Care initiative.
ICD-10: Feds tout resources available for Oct. 1 switch
Officials from the Centers for Medicare & Medicaid Services sought to assure physicians that the agency is on track for a smooth transition to ICD-10 on Oct. 1.
“We have proven that our claims processing center will be able to accept claims without any problems, and [the claims] will be paid,” Dr. William Rogers, ICD-10 ombudsman at CMS, said in a press conference Sept. 24.
Dr. Patrick H. Conway, CMS principal deputy administrator, added that real-time monitoring of the switch will take place so that the agency can “investigate and address issues as they come in through the ICD-10 coordination center.”
Dr. Rogers and Dr. Conway outlined a number of resources available to assist with the transition:
• General information is available is available at the Road to ICD-10 and www.cms.gov/ICD10.
• Should a problem or concern arise, turn first to your billing vendor or clearinghouse.
• Next, reach out to your Medicare administrative contractor (MAC).
• Questions and concerns can be emailed to the ICD-10 Coordination Center at [email protected].
• If there are still issues, email the ICD-10 ombudsman’s office at [email protected].Both Dr. Rogers and Dr. Conway downplayed concerns about whether stalled congressional budget negotiations, potentially leading to a government shutdown, would have any impact on the ICD-10 transition. They emphasized that patients will receive the same services on Oct. 1, when ICD-10 officially kicks off, as they did the day before.
Data on claims processing under ICD-10 will be available after one full billing cycle is complete, which should be about 30 days, Dr. Conway said.
On Twitter @whitneymcknight
Officials from the Centers for Medicare & Medicaid Services sought to assure physicians that the agency is on track for a smooth transition to ICD-10 on Oct. 1.
“We have proven that our claims processing center will be able to accept claims without any problems, and [the claims] will be paid,” Dr. William Rogers, ICD-10 ombudsman at CMS, said in a press conference Sept. 24.
Dr. Patrick H. Conway, CMS principal deputy administrator, added that real-time monitoring of the switch will take place so that the agency can “investigate and address issues as they come in through the ICD-10 coordination center.”
Dr. Rogers and Dr. Conway outlined a number of resources available to assist with the transition:
• General information is available is available at the Road to ICD-10 and www.cms.gov/ICD10.
• Should a problem or concern arise, turn first to your billing vendor or clearinghouse.
• Next, reach out to your Medicare administrative contractor (MAC).
• Questions and concerns can be emailed to the ICD-10 Coordination Center at [email protected].
• If there are still issues, email the ICD-10 ombudsman’s office at [email protected].Both Dr. Rogers and Dr. Conway downplayed concerns about whether stalled congressional budget negotiations, potentially leading to a government shutdown, would have any impact on the ICD-10 transition. They emphasized that patients will receive the same services on Oct. 1, when ICD-10 officially kicks off, as they did the day before.
Data on claims processing under ICD-10 will be available after one full billing cycle is complete, which should be about 30 days, Dr. Conway said.
On Twitter @whitneymcknight
Officials from the Centers for Medicare & Medicaid Services sought to assure physicians that the agency is on track for a smooth transition to ICD-10 on Oct. 1.
“We have proven that our claims processing center will be able to accept claims without any problems, and [the claims] will be paid,” Dr. William Rogers, ICD-10 ombudsman at CMS, said in a press conference Sept. 24.
Dr. Patrick H. Conway, CMS principal deputy administrator, added that real-time monitoring of the switch will take place so that the agency can “investigate and address issues as they come in through the ICD-10 coordination center.”
Dr. Rogers and Dr. Conway outlined a number of resources available to assist with the transition:
• General information is available is available at the Road to ICD-10 and www.cms.gov/ICD10.
• Should a problem or concern arise, turn first to your billing vendor or clearinghouse.
• Next, reach out to your Medicare administrative contractor (MAC).
• Questions and concerns can be emailed to the ICD-10 Coordination Center at [email protected].
• If there are still issues, email the ICD-10 ombudsman’s office at [email protected].Both Dr. Rogers and Dr. Conway downplayed concerns about whether stalled congressional budget negotiations, potentially leading to a government shutdown, would have any impact on the ICD-10 transition. They emphasized that patients will receive the same services on Oct. 1, when ICD-10 officially kicks off, as they did the day before.
Data on claims processing under ICD-10 will be available after one full billing cycle is complete, which should be about 30 days, Dr. Conway said.
On Twitter @whitneymcknight
Exercise found protective against effects of bullying, suicide
The more students exercised, the less likely they were to feel sad or suicidal, particularly if they were the victims of bullies, analysis of a population health survey has shown.
“[Our] data demonstrate that being physically active on 4 or more days per week was related to an approximate 23% reduction in the odds of both suicidal ideation and suicide attempt in bullied adolescents,” wrote Jeremy Sibold, Ed.D., associate professor of rehabilitation and movement science at the University of Vermont, Burlington, and his colleagues.
They analyzed data on 13,583 youths who participated in the 2013 National Youth Risk Behavior Survey (J Am Acad Child Adolesc Psychiatry. 2015 doi: 10.1016/j.jaac.2015.06.019).
The investigators found that 30% of respondents reported feeling sad for at least 2 weeks in the past 12 months, and 22% and 8% reported suicidal ideation or a suicide attempt, respectively (P less than .0001).
Over a quarter of all students reported they had been bullied in the past 12 months. Over half of these respondents reported that they felt sad as a result, with 39% of this group reporting they had suicidal thoughts and 18% reporting an attempted suicide.
Twenty-three percent of respondents reported feeling sad but had not been bullied. Of these, 14% reported suicidal ideation, with 5% having attempted suicide, Dr. Sibold and his associates reported.
Thirty-seven percent of bullied students who exercised 6-7 days per week reported suicidal ideation, compared with 46% of bullied students who exercised 0-1 day a week. Twelve percent of nonbullied students who exercised 6-7 days a week reported suicidal ideation, compared with 21% of nonbullied students who exercised 0-1 day. In addition, 16% of bullied students who exercised 6-7 days a week reported a suicide attempt, compared with 20% who exercised only 0-1 days. In nonbullied students who exercised 6-7 days per week, 4% reported a suicide attempt, versus 6% who exercised 0-1 day.
Students who were bullied and exercised 6-7 days a week had lower odds of suicidal ideation (adjusted odds ratio, 0.77), compared with bullied students who exercised 0-1 day a week. Bullied students who exercised 6-7 days had lower odds of suicide attempt (adjusted odds ratio, 0.81) than bullied students who exercised 0-1 day.
One of Dr. Sibold’s associates has received grant or research support from the National Institutes of Health, the National Institute of Mental Health, the National Institute of Diabetes and Digestive and Kidney Disease, and the state of Vermont. The other investigators reported no biomedical financial interests or potential conflicts of interest.
On Twitter @whitneymcknight
The more students exercised, the less likely they were to feel sad or suicidal, particularly if they were the victims of bullies, analysis of a population health survey has shown.
“[Our] data demonstrate that being physically active on 4 or more days per week was related to an approximate 23% reduction in the odds of both suicidal ideation and suicide attempt in bullied adolescents,” wrote Jeremy Sibold, Ed.D., associate professor of rehabilitation and movement science at the University of Vermont, Burlington, and his colleagues.
They analyzed data on 13,583 youths who participated in the 2013 National Youth Risk Behavior Survey (J Am Acad Child Adolesc Psychiatry. 2015 doi: 10.1016/j.jaac.2015.06.019).
The investigators found that 30% of respondents reported feeling sad for at least 2 weeks in the past 12 months, and 22% and 8% reported suicidal ideation or a suicide attempt, respectively (P less than .0001).
Over a quarter of all students reported they had been bullied in the past 12 months. Over half of these respondents reported that they felt sad as a result, with 39% of this group reporting they had suicidal thoughts and 18% reporting an attempted suicide.
Twenty-three percent of respondents reported feeling sad but had not been bullied. Of these, 14% reported suicidal ideation, with 5% having attempted suicide, Dr. Sibold and his associates reported.
Thirty-seven percent of bullied students who exercised 6-7 days per week reported suicidal ideation, compared with 46% of bullied students who exercised 0-1 day a week. Twelve percent of nonbullied students who exercised 6-7 days a week reported suicidal ideation, compared with 21% of nonbullied students who exercised 0-1 day. In addition, 16% of bullied students who exercised 6-7 days a week reported a suicide attempt, compared with 20% who exercised only 0-1 days. In nonbullied students who exercised 6-7 days per week, 4% reported a suicide attempt, versus 6% who exercised 0-1 day.
Students who were bullied and exercised 6-7 days a week had lower odds of suicidal ideation (adjusted odds ratio, 0.77), compared with bullied students who exercised 0-1 day a week. Bullied students who exercised 6-7 days had lower odds of suicide attempt (adjusted odds ratio, 0.81) than bullied students who exercised 0-1 day.
One of Dr. Sibold’s associates has received grant or research support from the National Institutes of Health, the National Institute of Mental Health, the National Institute of Diabetes and Digestive and Kidney Disease, and the state of Vermont. The other investigators reported no biomedical financial interests or potential conflicts of interest.
On Twitter @whitneymcknight
The more students exercised, the less likely they were to feel sad or suicidal, particularly if they were the victims of bullies, analysis of a population health survey has shown.
“[Our] data demonstrate that being physically active on 4 or more days per week was related to an approximate 23% reduction in the odds of both suicidal ideation and suicide attempt in bullied adolescents,” wrote Jeremy Sibold, Ed.D., associate professor of rehabilitation and movement science at the University of Vermont, Burlington, and his colleagues.
They analyzed data on 13,583 youths who participated in the 2013 National Youth Risk Behavior Survey (J Am Acad Child Adolesc Psychiatry. 2015 doi: 10.1016/j.jaac.2015.06.019).
The investigators found that 30% of respondents reported feeling sad for at least 2 weeks in the past 12 months, and 22% and 8% reported suicidal ideation or a suicide attempt, respectively (P less than .0001).
Over a quarter of all students reported they had been bullied in the past 12 months. Over half of these respondents reported that they felt sad as a result, with 39% of this group reporting they had suicidal thoughts and 18% reporting an attempted suicide.
Twenty-three percent of respondents reported feeling sad but had not been bullied. Of these, 14% reported suicidal ideation, with 5% having attempted suicide, Dr. Sibold and his associates reported.
Thirty-seven percent of bullied students who exercised 6-7 days per week reported suicidal ideation, compared with 46% of bullied students who exercised 0-1 day a week. Twelve percent of nonbullied students who exercised 6-7 days a week reported suicidal ideation, compared with 21% of nonbullied students who exercised 0-1 day. In addition, 16% of bullied students who exercised 6-7 days a week reported a suicide attempt, compared with 20% who exercised only 0-1 days. In nonbullied students who exercised 6-7 days per week, 4% reported a suicide attempt, versus 6% who exercised 0-1 day.
Students who were bullied and exercised 6-7 days a week had lower odds of suicidal ideation (adjusted odds ratio, 0.77), compared with bullied students who exercised 0-1 day a week. Bullied students who exercised 6-7 days had lower odds of suicide attempt (adjusted odds ratio, 0.81) than bullied students who exercised 0-1 day.
One of Dr. Sibold’s associates has received grant or research support from the National Institutes of Health, the National Institute of Mental Health, the National Institute of Diabetes and Digestive and Kidney Disease, and the state of Vermont. The other investigators reported no biomedical financial interests or potential conflicts of interest.
On Twitter @whitneymcknight
FROM THE JOURNAL OF THE AMERICAN ACADEMY OF CHILD AND ADOLESCENT PSYCHIATRY
Negative findings on oxytocin in schizophrenia spur some to ‘move on’
AMSTERDAM – For decades, researchers have studied whether oxytocin has the potential to have a therapeutic effect in schizophrenia. Recently, however, the lack of consistently positive findings has caused some to wonder whether the hormone’s value as a schizophrenia treatment is at a dead end.
“There are plenty of good reasons to study this,” said Dr. Mark Weiser, chair of the psychiatry department at Tel Aviv University, in an interview conducted at the annual congress of the European College of Neuropsychopharmacology. “It looks really promising from the nonclinical data.”
One recent study found that patients with schizophrenia tend to have lower plasma levels of the hormone but more positive symptoms of the disease than do controls. People on the autism spectrum who have resulting social deficits, similar to those in schizophrenia, also have been shown to have lower plasma levels of oxytocin (Biol Psychiatry. 2007 Feb 15;61:498-503); (Proc Natl Acad Sci U S A. 2010 Mar 2;107[9]:4389-94.); and (Biol Psychiatry. 2010 Apr 1;67[7]:692-4.).
A study published earlier this year showed that while oxytocin pathway genes were not implicated in a person’s susceptibility to psychotic disorders, variations in the genes “might play a role in the development of impaired social behavior” (Front Hum Neurosci. 2015 Jan 23;9:9). Still, the absence of replicable positive studies and the increasing number of investigations with negative results, such as the randomized, controlled trial conducted by Dr. Weiser and his colleagues, has led Dr. Weiser to conclude that despite intimations of promise over the years, it’s time to just move on.
“There is a reasonable amount of clinical data raising questions about whether it’s worth spending time and effort on doing further clinical trials [on oxytocin in schizophrenia],” Dr. Weiser said. “Even when you look at the so-called positive findings and go into the data, they don’t really come out to be positive.”
He cited a recent meta-analysis that concluded oxytocin’s effect on cognition was “too diverse for meta-analyses, and inspection of these data showed no consistent benefit” (Schizophr Res. 2015 Apr 23. pii: S0920-9964[15]00174-7.).
Dr. Weiser began his own inquiry under the premise that the “feel-good” hormone implicated in a person’s experience of love and intimacy would help those with schizophrenia better read and understand the emotional cues of others, fostering better social functioning as a result.
Previous studies have shown that oxytocin in people with schizophrenia mitigate their positive and negative symptoms, and the hormone has been associated with increased levels of trust (Depress Anxiety. 2012 Nov;29[11]: 924-30); (Physiol Behav. 2011 Feb 1;102[2]:221-4.).
But in Dr. Weiser’s study, only nonsignificant differences were found in social functioning between those given placebo, and either supportive therapy or social skills training and those given intranasal oxytocin and one of the two talk therapies.
“My data do not support developing this,” Dr. Weiser said in the interview. There is “perhaps” promise, he said for those who’d like to spend the time and effort conducting meta-analyses of individual patient data from a range of studies and doing comparative analyses. But the time necessary to do so, plus the theoretical issues to clarify, such as whether it would be better to separate patients with well-established schizophrenia from those with first-episode or to evaluate them together, or what the primary outcome measures should be, make it unlikely such an analysis will take place. “It’s what should be done,” but, he said, “Given the negative findings, no one is going to fund it.”
Yet some experts – such as Inga D. Neumann, Ph.D., chair of behavioral and molecular neurobiology at the University of Regensburg (Germany) – argue that the therapeutic promise of oxytocin in schizophrenia is there. But they say the studies to date have not been well designed.
According to Dr. Neumann, the duration of treatment and the levels of synthetic oxytocin used in human studies interfere with the endogenous oxytocin system. In an interview at the ECNP meeting, Dr. Neumann said the typical human study uses more oxytocin “than the body’s entire pituitary content and is supplied in a single shot twice daily over 5 or 6 weeks.” Animal studies have shown that such intense and chronic treatment leads to the decrease of oxytocin receptors in the brain and overall impairment of the oxytocin system. “The down-regulation of the receptors is important to consider” but often isn’t, she said.
The level of damage to the endogenous system incurred, and whether it is permanent in these bench studies remain unknown. But levels of oxytocin receptors in the limbic regions of the brain are still suppressed at least 3 weeks after oxytocin treatments are stopped. “These are only in animal studies,” Dr. Neumann said. “What we could do in humans is to test their oxytocin systems right before treatment, right after it, and then, say, half a year later to see if there are changes in the system.”
Dr. Neumann believes clinical studies also should first determine what a high level of oxytocin looks like in healthy people whose oxytocin systems have been stimulated vs. what constitutes a high level in those whose systems are impaired, such in those with schizophrenia. In her work with animals, Dr. Neumann said she has found that different kinds of stimulation, whether it be exercise, sex, or stress, lead to different levels of oxytocin released into the blood stream. These kinds of data from humans would help determine the right amount of the hormone necessary to establish a positive treatment effect. “This should be done more in laboratories, not just the taking of basal levels. Basal levels mean nothing.”
Deanna L. Kelly, Pharm.D., professor of psychiatry and the director of the treatment research program at the University of Maryland, Baltimore, also wonders about trial designs, albeit her more pressing concerns are how the study drug is administered and in what setting.
“I think it’s important for us as a field to make sure we’re delivering [oxytocin] appropriately,” Dr. Kelly said during a presentation at the meeting. She noted her theory that, of the single-dose challenge studies in schizophrenia that have shown an effect on social cognition, most were likely conducted under tight supervision to ensure the medication was “delivered properly.”
Dr. Kelly presented her own negative data from a study of 56 people, mostly men in their mid- to late 40s with schizophrenia or schizoaffective disorder, selected for their enduring negative symptoms. Participants were treated either in an in- or outpatient setting based on their normal treatment regimen and were randomly assigned to receive either placebo, oxytocin, or the acetylcholinesterase inhibitor galantamine.
Oxytocin, which was administered intranasally at 24 IU twice daily, was chosen for its effect on negative symptoms in schizophrenia. Galantamine – often used to treat impaired cognition in Alzheimer’s disease – was dosed orally at 12 mg twice daily and was intended to address cognitive deficits. After a 4-week lead-in phase and 6 weeks of double-blind treatment, neither of the study drugs was found superior to placebo when it came to improving either negative symptoms or cognitive processes.
Some differences were found between those in the in- and outpatient settings, although they were not significant. However, in a previous study, Dr. Kelly conducted with her colleagues, patients treated with intranasal oxytocin in the inpatient setting showed significant improvement vs. controls treated in the inpatient setting. However, they did not find an overall negative symptom effect, and no difference was found among those treated as outpatients (Schizophr Res. 2013 Apr;145[0]:110-5).
“It could be that these patients are more closely watched by the nursing staff, and they’re getting the six sprays twice daily into the nose, whereas the outpatients might not be spraying it correctly ... [so that] it gets into the brain,” Dr. Kelly said.
For his part, Dr. Weiser said his study might have been too short in duration with too few subjects who already were too far into their disease state. The 48 people in his 3-week study were typically male, 37 years old, and with an average age of disease onset of about 23 years. Positive and Negative Syndrome Scale (PANSS) scores were about 69 for the study group and 66 for the placebo group.
“Perhaps patients with more severe PANSS scores might show more improvement,” Dr. Weiser said in his presentation.
Regardless, unless a genetic breakthrough occurs that helps identify subgroups of people in whom oxytocin treatments would have a positive effect, Dr. Weiser thinks interest in oxytocin for schizophrenia should end.
“The field is thirsty for something that works for schizophrenia,” said Dr. Weiser in the interview. “But regardless of wonderful preclinical [findings] on oxytocin, if the bottom line is that when you give it to patients they don’t get better, then we need to figure out a different intervention to try.”
Not so fast, Dr. Neumann says. “We have to look more carefully. We can’t just take any patients, treat them with a huge, superficial dose and then think, ‘Oh, this will do something.’ We have to do better homework.”
Dr. Weiser’s and Dr. Kelly’s respective research is funded by the Stanley Medical Research Institute. Dr. Kelly is an adviser to Lundbeck and XOMA.
On Twitter @whitneymcknight
AMSTERDAM – For decades, researchers have studied whether oxytocin has the potential to have a therapeutic effect in schizophrenia. Recently, however, the lack of consistently positive findings has caused some to wonder whether the hormone’s value as a schizophrenia treatment is at a dead end.
“There are plenty of good reasons to study this,” said Dr. Mark Weiser, chair of the psychiatry department at Tel Aviv University, in an interview conducted at the annual congress of the European College of Neuropsychopharmacology. “It looks really promising from the nonclinical data.”
One recent study found that patients with schizophrenia tend to have lower plasma levels of the hormone but more positive symptoms of the disease than do controls. People on the autism spectrum who have resulting social deficits, similar to those in schizophrenia, also have been shown to have lower plasma levels of oxytocin (Biol Psychiatry. 2007 Feb 15;61:498-503); (Proc Natl Acad Sci U S A. 2010 Mar 2;107[9]:4389-94.); and (Biol Psychiatry. 2010 Apr 1;67[7]:692-4.).
A study published earlier this year showed that while oxytocin pathway genes were not implicated in a person’s susceptibility to psychotic disorders, variations in the genes “might play a role in the development of impaired social behavior” (Front Hum Neurosci. 2015 Jan 23;9:9). Still, the absence of replicable positive studies and the increasing number of investigations with negative results, such as the randomized, controlled trial conducted by Dr. Weiser and his colleagues, has led Dr. Weiser to conclude that despite intimations of promise over the years, it’s time to just move on.
“There is a reasonable amount of clinical data raising questions about whether it’s worth spending time and effort on doing further clinical trials [on oxytocin in schizophrenia],” Dr. Weiser said. “Even when you look at the so-called positive findings and go into the data, they don’t really come out to be positive.”
He cited a recent meta-analysis that concluded oxytocin’s effect on cognition was “too diverse for meta-analyses, and inspection of these data showed no consistent benefit” (Schizophr Res. 2015 Apr 23. pii: S0920-9964[15]00174-7.).
Dr. Weiser began his own inquiry under the premise that the “feel-good” hormone implicated in a person’s experience of love and intimacy would help those with schizophrenia better read and understand the emotional cues of others, fostering better social functioning as a result.
Previous studies have shown that oxytocin in people with schizophrenia mitigate their positive and negative symptoms, and the hormone has been associated with increased levels of trust (Depress Anxiety. 2012 Nov;29[11]: 924-30); (Physiol Behav. 2011 Feb 1;102[2]:221-4.).
But in Dr. Weiser’s study, only nonsignificant differences were found in social functioning between those given placebo, and either supportive therapy or social skills training and those given intranasal oxytocin and one of the two talk therapies.
“My data do not support developing this,” Dr. Weiser said in the interview. There is “perhaps” promise, he said for those who’d like to spend the time and effort conducting meta-analyses of individual patient data from a range of studies and doing comparative analyses. But the time necessary to do so, plus the theoretical issues to clarify, such as whether it would be better to separate patients with well-established schizophrenia from those with first-episode or to evaluate them together, or what the primary outcome measures should be, make it unlikely such an analysis will take place. “It’s what should be done,” but, he said, “Given the negative findings, no one is going to fund it.”
Yet some experts – such as Inga D. Neumann, Ph.D., chair of behavioral and molecular neurobiology at the University of Regensburg (Germany) – argue that the therapeutic promise of oxytocin in schizophrenia is there. But they say the studies to date have not been well designed.
According to Dr. Neumann, the duration of treatment and the levels of synthetic oxytocin used in human studies interfere with the endogenous oxytocin system. In an interview at the ECNP meeting, Dr. Neumann said the typical human study uses more oxytocin “than the body’s entire pituitary content and is supplied in a single shot twice daily over 5 or 6 weeks.” Animal studies have shown that such intense and chronic treatment leads to the decrease of oxytocin receptors in the brain and overall impairment of the oxytocin system. “The down-regulation of the receptors is important to consider” but often isn’t, she said.
The level of damage to the endogenous system incurred, and whether it is permanent in these bench studies remain unknown. But levels of oxytocin receptors in the limbic regions of the brain are still suppressed at least 3 weeks after oxytocin treatments are stopped. “These are only in animal studies,” Dr. Neumann said. “What we could do in humans is to test their oxytocin systems right before treatment, right after it, and then, say, half a year later to see if there are changes in the system.”
Dr. Neumann believes clinical studies also should first determine what a high level of oxytocin looks like in healthy people whose oxytocin systems have been stimulated vs. what constitutes a high level in those whose systems are impaired, such in those with schizophrenia. In her work with animals, Dr. Neumann said she has found that different kinds of stimulation, whether it be exercise, sex, or stress, lead to different levels of oxytocin released into the blood stream. These kinds of data from humans would help determine the right amount of the hormone necessary to establish a positive treatment effect. “This should be done more in laboratories, not just the taking of basal levels. Basal levels mean nothing.”
Deanna L. Kelly, Pharm.D., professor of psychiatry and the director of the treatment research program at the University of Maryland, Baltimore, also wonders about trial designs, albeit her more pressing concerns are how the study drug is administered and in what setting.
“I think it’s important for us as a field to make sure we’re delivering [oxytocin] appropriately,” Dr. Kelly said during a presentation at the meeting. She noted her theory that, of the single-dose challenge studies in schizophrenia that have shown an effect on social cognition, most were likely conducted under tight supervision to ensure the medication was “delivered properly.”
Dr. Kelly presented her own negative data from a study of 56 people, mostly men in their mid- to late 40s with schizophrenia or schizoaffective disorder, selected for their enduring negative symptoms. Participants were treated either in an in- or outpatient setting based on their normal treatment regimen and were randomly assigned to receive either placebo, oxytocin, or the acetylcholinesterase inhibitor galantamine.
Oxytocin, which was administered intranasally at 24 IU twice daily, was chosen for its effect on negative symptoms in schizophrenia. Galantamine – often used to treat impaired cognition in Alzheimer’s disease – was dosed orally at 12 mg twice daily and was intended to address cognitive deficits. After a 4-week lead-in phase and 6 weeks of double-blind treatment, neither of the study drugs was found superior to placebo when it came to improving either negative symptoms or cognitive processes.
Some differences were found between those in the in- and outpatient settings, although they were not significant. However, in a previous study, Dr. Kelly conducted with her colleagues, patients treated with intranasal oxytocin in the inpatient setting showed significant improvement vs. controls treated in the inpatient setting. However, they did not find an overall negative symptom effect, and no difference was found among those treated as outpatients (Schizophr Res. 2013 Apr;145[0]:110-5).
“It could be that these patients are more closely watched by the nursing staff, and they’re getting the six sprays twice daily into the nose, whereas the outpatients might not be spraying it correctly ... [so that] it gets into the brain,” Dr. Kelly said.
For his part, Dr. Weiser said his study might have been too short in duration with too few subjects who already were too far into their disease state. The 48 people in his 3-week study were typically male, 37 years old, and with an average age of disease onset of about 23 years. Positive and Negative Syndrome Scale (PANSS) scores were about 69 for the study group and 66 for the placebo group.
“Perhaps patients with more severe PANSS scores might show more improvement,” Dr. Weiser said in his presentation.
Regardless, unless a genetic breakthrough occurs that helps identify subgroups of people in whom oxytocin treatments would have a positive effect, Dr. Weiser thinks interest in oxytocin for schizophrenia should end.
“The field is thirsty for something that works for schizophrenia,” said Dr. Weiser in the interview. “But regardless of wonderful preclinical [findings] on oxytocin, if the bottom line is that when you give it to patients they don’t get better, then we need to figure out a different intervention to try.”
Not so fast, Dr. Neumann says. “We have to look more carefully. We can’t just take any patients, treat them with a huge, superficial dose and then think, ‘Oh, this will do something.’ We have to do better homework.”
Dr. Weiser’s and Dr. Kelly’s respective research is funded by the Stanley Medical Research Institute. Dr. Kelly is an adviser to Lundbeck and XOMA.
On Twitter @whitneymcknight
AMSTERDAM – For decades, researchers have studied whether oxytocin has the potential to have a therapeutic effect in schizophrenia. Recently, however, the lack of consistently positive findings has caused some to wonder whether the hormone’s value as a schizophrenia treatment is at a dead end.
“There are plenty of good reasons to study this,” said Dr. Mark Weiser, chair of the psychiatry department at Tel Aviv University, in an interview conducted at the annual congress of the European College of Neuropsychopharmacology. “It looks really promising from the nonclinical data.”
One recent study found that patients with schizophrenia tend to have lower plasma levels of the hormone but more positive symptoms of the disease than do controls. People on the autism spectrum who have resulting social deficits, similar to those in schizophrenia, also have been shown to have lower plasma levels of oxytocin (Biol Psychiatry. 2007 Feb 15;61:498-503); (Proc Natl Acad Sci U S A. 2010 Mar 2;107[9]:4389-94.); and (Biol Psychiatry. 2010 Apr 1;67[7]:692-4.).
A study published earlier this year showed that while oxytocin pathway genes were not implicated in a person’s susceptibility to psychotic disorders, variations in the genes “might play a role in the development of impaired social behavior” (Front Hum Neurosci. 2015 Jan 23;9:9). Still, the absence of replicable positive studies and the increasing number of investigations with negative results, such as the randomized, controlled trial conducted by Dr. Weiser and his colleagues, has led Dr. Weiser to conclude that despite intimations of promise over the years, it’s time to just move on.
“There is a reasonable amount of clinical data raising questions about whether it’s worth spending time and effort on doing further clinical trials [on oxytocin in schizophrenia],” Dr. Weiser said. “Even when you look at the so-called positive findings and go into the data, they don’t really come out to be positive.”
He cited a recent meta-analysis that concluded oxytocin’s effect on cognition was “too diverse for meta-analyses, and inspection of these data showed no consistent benefit” (Schizophr Res. 2015 Apr 23. pii: S0920-9964[15]00174-7.).
Dr. Weiser began his own inquiry under the premise that the “feel-good” hormone implicated in a person’s experience of love and intimacy would help those with schizophrenia better read and understand the emotional cues of others, fostering better social functioning as a result.
Previous studies have shown that oxytocin in people with schizophrenia mitigate their positive and negative symptoms, and the hormone has been associated with increased levels of trust (Depress Anxiety. 2012 Nov;29[11]: 924-30); (Physiol Behav. 2011 Feb 1;102[2]:221-4.).
But in Dr. Weiser’s study, only nonsignificant differences were found in social functioning between those given placebo, and either supportive therapy or social skills training and those given intranasal oxytocin and one of the two talk therapies.
“My data do not support developing this,” Dr. Weiser said in the interview. There is “perhaps” promise, he said for those who’d like to spend the time and effort conducting meta-analyses of individual patient data from a range of studies and doing comparative analyses. But the time necessary to do so, plus the theoretical issues to clarify, such as whether it would be better to separate patients with well-established schizophrenia from those with first-episode or to evaluate them together, or what the primary outcome measures should be, make it unlikely such an analysis will take place. “It’s what should be done,” but, he said, “Given the negative findings, no one is going to fund it.”
Yet some experts – such as Inga D. Neumann, Ph.D., chair of behavioral and molecular neurobiology at the University of Regensburg (Germany) – argue that the therapeutic promise of oxytocin in schizophrenia is there. But they say the studies to date have not been well designed.
According to Dr. Neumann, the duration of treatment and the levels of synthetic oxytocin used in human studies interfere with the endogenous oxytocin system. In an interview at the ECNP meeting, Dr. Neumann said the typical human study uses more oxytocin “than the body’s entire pituitary content and is supplied in a single shot twice daily over 5 or 6 weeks.” Animal studies have shown that such intense and chronic treatment leads to the decrease of oxytocin receptors in the brain and overall impairment of the oxytocin system. “The down-regulation of the receptors is important to consider” but often isn’t, she said.
The level of damage to the endogenous system incurred, and whether it is permanent in these bench studies remain unknown. But levels of oxytocin receptors in the limbic regions of the brain are still suppressed at least 3 weeks after oxytocin treatments are stopped. “These are only in animal studies,” Dr. Neumann said. “What we could do in humans is to test their oxytocin systems right before treatment, right after it, and then, say, half a year later to see if there are changes in the system.”
Dr. Neumann believes clinical studies also should first determine what a high level of oxytocin looks like in healthy people whose oxytocin systems have been stimulated vs. what constitutes a high level in those whose systems are impaired, such in those with schizophrenia. In her work with animals, Dr. Neumann said she has found that different kinds of stimulation, whether it be exercise, sex, or stress, lead to different levels of oxytocin released into the blood stream. These kinds of data from humans would help determine the right amount of the hormone necessary to establish a positive treatment effect. “This should be done more in laboratories, not just the taking of basal levels. Basal levels mean nothing.”
Deanna L. Kelly, Pharm.D., professor of psychiatry and the director of the treatment research program at the University of Maryland, Baltimore, also wonders about trial designs, albeit her more pressing concerns are how the study drug is administered and in what setting.
“I think it’s important for us as a field to make sure we’re delivering [oxytocin] appropriately,” Dr. Kelly said during a presentation at the meeting. She noted her theory that, of the single-dose challenge studies in schizophrenia that have shown an effect on social cognition, most were likely conducted under tight supervision to ensure the medication was “delivered properly.”
Dr. Kelly presented her own negative data from a study of 56 people, mostly men in their mid- to late 40s with schizophrenia or schizoaffective disorder, selected for their enduring negative symptoms. Participants were treated either in an in- or outpatient setting based on their normal treatment regimen and were randomly assigned to receive either placebo, oxytocin, or the acetylcholinesterase inhibitor galantamine.
Oxytocin, which was administered intranasally at 24 IU twice daily, was chosen for its effect on negative symptoms in schizophrenia. Galantamine – often used to treat impaired cognition in Alzheimer’s disease – was dosed orally at 12 mg twice daily and was intended to address cognitive deficits. After a 4-week lead-in phase and 6 weeks of double-blind treatment, neither of the study drugs was found superior to placebo when it came to improving either negative symptoms or cognitive processes.
Some differences were found between those in the in- and outpatient settings, although they were not significant. However, in a previous study, Dr. Kelly conducted with her colleagues, patients treated with intranasal oxytocin in the inpatient setting showed significant improvement vs. controls treated in the inpatient setting. However, they did not find an overall negative symptom effect, and no difference was found among those treated as outpatients (Schizophr Res. 2013 Apr;145[0]:110-5).
“It could be that these patients are more closely watched by the nursing staff, and they’re getting the six sprays twice daily into the nose, whereas the outpatients might not be spraying it correctly ... [so that] it gets into the brain,” Dr. Kelly said.
For his part, Dr. Weiser said his study might have been too short in duration with too few subjects who already were too far into their disease state. The 48 people in his 3-week study were typically male, 37 years old, and with an average age of disease onset of about 23 years. Positive and Negative Syndrome Scale (PANSS) scores were about 69 for the study group and 66 for the placebo group.
“Perhaps patients with more severe PANSS scores might show more improvement,” Dr. Weiser said in his presentation.
Regardless, unless a genetic breakthrough occurs that helps identify subgroups of people in whom oxytocin treatments would have a positive effect, Dr. Weiser thinks interest in oxytocin for schizophrenia should end.
“The field is thirsty for something that works for schizophrenia,” said Dr. Weiser in the interview. “But regardless of wonderful preclinical [findings] on oxytocin, if the bottom line is that when you give it to patients they don’t get better, then we need to figure out a different intervention to try.”
Not so fast, Dr. Neumann says. “We have to look more carefully. We can’t just take any patients, treat them with a huge, superficial dose and then think, ‘Oh, this will do something.’ We have to do better homework.”
Dr. Weiser’s and Dr. Kelly’s respective research is funded by the Stanley Medical Research Institute. Dr. Kelly is an adviser to Lundbeck and XOMA.
On Twitter @whitneymcknight
EXPERT ANALYSIS AT THE ECNP CONGRESS
New atypical antipsychotic FDA approved for use in bipolar I and schizophrenia
The Food and Drug Administration on Sept. 17 approved cariprazine, an atypical antipsychotic, for the acute treatment of manic or mixed episodes in bipolar I disorder and schizophrenia in adults.
Results from three separate controlled trials in adults with manic or mixed episodes of bipolar I disorder showed cariprazine (Vraylar) was associated with improved total scores on the Young Mania Rating Scale (YMRS), compared with placebo. In three separate placebo-controlled trials in adults with schizophrenia, the study drug was associated with improvements in Positive and Negative Syndrome Scale (PANSS) total scores, compared with placebo. Cariprazine also demonstrated efficacy in the Clinical Global Impressions–Severity (CGI-S) rating scale, which was the secondary efficacy endpoint in the respective trials for each condition. In all, 2,700 persons were enrolled in the trials.
The recommended dose of cariprazine in adults with bipolar I is once daily at 3-6 mg per day. For schizophrenia in adults, 1.5-6 mg/day is the recommended dose.
Adverse reactions occurring in at least 5% of the study population and at a rate of twice that in the placebo groups were extrapyramidal symptoms, akathisia, dyspepsia, vomiting, somnolence, and restlessness in the bipolar group. In the group with schizophrenia, the most commonly reported adverse events were extrapyramidal symptoms and akathisia.
Cariprazine is a dopamine-2 and dopamine-3 receptor partial agonist, tending toward the D3 receptor. Although its mechanism of action in schizophrenia and bipolar I disorder is unknown, the drug’s codeveloper, Gedeon Richter said in a statement that cariprazine’s efficacy “could be mediated through a combination of partial agonist activity at central D2 and serotonin 5-HT1A receptors and antagonist activity at serotonin 5-HT2A receptors.” In the United States and Canada, the drug is licensed to Actavis, now Allergan. Vraylar is manufactured by Forest Laboratories.
Data indicating the drug’s ability to improve flat affect in schizophrenia were presented at this year’s annual congress of the European College of Neuropsychopharmacology in Amsterdam. According to Gedeon Richter and Allergan, cariprazine also is being investigated for the treatment of bipolar depression and as adjunctive treatment for major depressive disorder in adults.
On Twitter @whitneymcknight
*This article was updated 9/18/2015.
The Food and Drug Administration on Sept. 17 approved cariprazine, an atypical antipsychotic, for the acute treatment of manic or mixed episodes in bipolar I disorder and schizophrenia in adults.
Results from three separate controlled trials in adults with manic or mixed episodes of bipolar I disorder showed cariprazine (Vraylar) was associated with improved total scores on the Young Mania Rating Scale (YMRS), compared with placebo. In three separate placebo-controlled trials in adults with schizophrenia, the study drug was associated with improvements in Positive and Negative Syndrome Scale (PANSS) total scores, compared with placebo. Cariprazine also demonstrated efficacy in the Clinical Global Impressions–Severity (CGI-S) rating scale, which was the secondary efficacy endpoint in the respective trials for each condition. In all, 2,700 persons were enrolled in the trials.
The recommended dose of cariprazine in adults with bipolar I is once daily at 3-6 mg per day. For schizophrenia in adults, 1.5-6 mg/day is the recommended dose.
Adverse reactions occurring in at least 5% of the study population and at a rate of twice that in the placebo groups were extrapyramidal symptoms, akathisia, dyspepsia, vomiting, somnolence, and restlessness in the bipolar group. In the group with schizophrenia, the most commonly reported adverse events were extrapyramidal symptoms and akathisia.
Cariprazine is a dopamine-2 and dopamine-3 receptor partial agonist, tending toward the D3 receptor. Although its mechanism of action in schizophrenia and bipolar I disorder is unknown, the drug’s codeveloper, Gedeon Richter said in a statement that cariprazine’s efficacy “could be mediated through a combination of partial agonist activity at central D2 and serotonin 5-HT1A receptors and antagonist activity at serotonin 5-HT2A receptors.” In the United States and Canada, the drug is licensed to Actavis, now Allergan. Vraylar is manufactured by Forest Laboratories.
Data indicating the drug’s ability to improve flat affect in schizophrenia were presented at this year’s annual congress of the European College of Neuropsychopharmacology in Amsterdam. According to Gedeon Richter and Allergan, cariprazine also is being investigated for the treatment of bipolar depression and as adjunctive treatment for major depressive disorder in adults.
On Twitter @whitneymcknight
*This article was updated 9/18/2015.
The Food and Drug Administration on Sept. 17 approved cariprazine, an atypical antipsychotic, for the acute treatment of manic or mixed episodes in bipolar I disorder and schizophrenia in adults.
Results from three separate controlled trials in adults with manic or mixed episodes of bipolar I disorder showed cariprazine (Vraylar) was associated with improved total scores on the Young Mania Rating Scale (YMRS), compared with placebo. In three separate placebo-controlled trials in adults with schizophrenia, the study drug was associated with improvements in Positive and Negative Syndrome Scale (PANSS) total scores, compared with placebo. Cariprazine also demonstrated efficacy in the Clinical Global Impressions–Severity (CGI-S) rating scale, which was the secondary efficacy endpoint in the respective trials for each condition. In all, 2,700 persons were enrolled in the trials.
The recommended dose of cariprazine in adults with bipolar I is once daily at 3-6 mg per day. For schizophrenia in adults, 1.5-6 mg/day is the recommended dose.
Adverse reactions occurring in at least 5% of the study population and at a rate of twice that in the placebo groups were extrapyramidal symptoms, akathisia, dyspepsia, vomiting, somnolence, and restlessness in the bipolar group. In the group with schizophrenia, the most commonly reported adverse events were extrapyramidal symptoms and akathisia.
Cariprazine is a dopamine-2 and dopamine-3 receptor partial agonist, tending toward the D3 receptor. Although its mechanism of action in schizophrenia and bipolar I disorder is unknown, the drug’s codeveloper, Gedeon Richter said in a statement that cariprazine’s efficacy “could be mediated through a combination of partial agonist activity at central D2 and serotonin 5-HT1A receptors and antagonist activity at serotonin 5-HT2A receptors.” In the United States and Canada, the drug is licensed to Actavis, now Allergan. Vraylar is manufactured by Forest Laboratories.
Data indicating the drug’s ability to improve flat affect in schizophrenia were presented at this year’s annual congress of the European College of Neuropsychopharmacology in Amsterdam. According to Gedeon Richter and Allergan, cariprazine also is being investigated for the treatment of bipolar depression and as adjunctive treatment for major depressive disorder in adults.
On Twitter @whitneymcknight
*This article was updated 9/18/2015.
