Whitney McKnight

A small number of women reported adverse events related to hypotension and syncope while taking flibanserin and drinking alcohol, an analysis of data from five phase III trials has shown.

Flibanserin is the first drug approved by the Food and Drug Administration for low female sexual desire in premenopausal women. When the FDA approved flibanserin in August 2015, the agency gave it a boxed warning contraindicating alcohol use with the drug because of a risk of severe hypotension and syncope. The FDA also directed Sprout Pharmaceuticals, who markets the drug as Addyi, to conduct postmarket studies into the relationship between hypotension- and syncope-related events concurrent with alcohol use.

Courtesy Sprout Pharmaceuticals

Flibanserin is metabolized through the CYP3A4 system, creating the potential for drug-drug and drug-alcohol interactions. A mixed agonist/antagonist for serotonin and dopamine receptors, flibanserin is taken orally at bedtime on a long-term basis, typically in doses of 100 mg.

Events related to hypotension and syncope include circulatory collapse, hypotension, loss of consciousness, orthostatic hypotension, syncope, vasovagal syncope, and light-headedness.

The industry-funded post hoc analysis included data from five phase III randomized, double-blind placebo-controlled studies of 3,448 premenopausal women. Of the 1,543 taking flibanserin 100 mg at bedtime for up to 24 weeks, 898 reported alcohol use at baseline. Six of these women reported a total of eight adverse events related to hypotension and syncope. In addition, two women who took flibanserin and reported they did not use alcohol had syncope-related events.

Of the 1,905 women taking a placebo, 1,212 reported alcohol use at baseline. Four of these women reported hypotension- and syncope-related adverse events. One woman in the placebo group who reported no alcohol use had two syncope-related adverse events.

Discontinuation rates due to hypotension or syncope among flibanserin users were virtually the same among those who did and did not report alcohol use: 1.8% vs. 1.7%. Among women in the placebo group, those who did not use alcohol had a discontinuation rate of 0.3%, while alcohol users who received placebo had a discontinuation rate of 0.15%.

“It is interesting to note that of the six alcohol users who took flibanserin and had syncopal or hypotensive episodes, four of them continued dosing and completed the study,” Dr. Stuart Apfel, the study’s lead author, said in an interview. “Of the two who did discontinue, one did so because of the syncopal event; the other did so because of somnolence, which is the most common side effect whether one takes alcohol with it or not.”

Dr. Apfel and his colleagues acknowledged that the analysis was limited by the fact that alcohol use was based on self-reports, rather than direct measurement. However, when asked if the drug is safe even if a woman has used alcohol more than she has reported, Dr. Apfel said he personally believes it’s safe, based on the data.

Although there is an increased risk of hypotension and/or syncope with the combination of alcohol use and flibanserin, Dr. Apfel said the risk “appears to be very small, and only moderately higher than [for] those who did not take alcohol.” But the FDA appears to disagree, and after reviewing these same data, required that alcohol use be listed as a contraindication, he added. “I personally don’t think the data indicates that there is a major risk, but it is obviously open to interpretation.”

Dr. Apfel is a consultant to Sprout Pharmaceuticals and Valeant Pharmaceuticals. The studies were supported by Boehringer Ingelheim. Other support was provided by Valeant Pharmaceuticals. The data were presented at the 2016 American Urological Association annual meeting in San Diego.

[email protected]

On Twitter @whitneymcknight

A small number of women reported adverse events related to hypotension and syncope while taking flibanserin and drinking alcohol, an analysis of data from five phase III trials has shown.

Flibanserin is the first drug approved by the Food and Drug Administration for low female sexual desire in premenopausal women. When the FDA approved flibanserin in August 2015, the agency gave it a boxed warning contraindicating alcohol use with the drug because of a risk of severe hypotension and syncope. The FDA also directed Sprout Pharmaceuticals, who markets the drug as Addyi, to conduct postmarket studies into the relationship between hypotension- and syncope-related events concurrent with alcohol use.

Courtesy Sprout Pharmaceuticals

Flibanserin is metabolized through the CYP3A4 system, creating the potential for drug-drug and drug-alcohol interactions. A mixed agonist/antagonist for serotonin and dopamine receptors, flibanserin is taken orally at bedtime on a long-term basis, typically in doses of 100 mg.

Events related to hypotension and syncope include circulatory collapse, hypotension, loss of consciousness, orthostatic hypotension, syncope, vasovagal syncope, and light-headedness.

The industry-funded post hoc analysis included data from five phase III randomized, double-blind placebo-controlled studies of 3,448 premenopausal women. Of the 1,543 taking flibanserin 100 mg at bedtime for up to 24 weeks, 898 reported alcohol use at baseline. Six of these women reported a total of eight adverse events related to hypotension and syncope. In addition, two women who took flibanserin and reported they did not use alcohol had syncope-related events.

Of the 1,905 women taking a placebo, 1,212 reported alcohol use at baseline. Four of these women reported hypotension- and syncope-related adverse events. One woman in the placebo group who reported no alcohol use had two syncope-related adverse events.

Discontinuation rates due to hypotension or syncope among flibanserin users were virtually the same among those who did and did not report alcohol use: 1.8% vs. 1.7%. Among women in the placebo group, those who did not use alcohol had a discontinuation rate of 0.3%, while alcohol users who received placebo had a discontinuation rate of 0.15%.

“It is interesting to note that of the six alcohol users who took flibanserin and had syncopal or hypotensive episodes, four of them continued dosing and completed the study,” Dr. Stuart Apfel, the study’s lead author, said in an interview. “Of the two who did discontinue, one did so because of the syncopal event; the other did so because of somnolence, which is the most common side effect whether one takes alcohol with it or not.”

Dr. Apfel and his colleagues acknowledged that the analysis was limited by the fact that alcohol use was based on self-reports, rather than direct measurement. However, when asked if the drug is safe even if a woman has used alcohol more than she has reported, Dr. Apfel said he personally believes it’s safe, based on the data.

Although there is an increased risk of hypotension and/or syncope with the combination of alcohol use and flibanserin, Dr. Apfel said the risk “appears to be very small, and only moderately higher than [for] those who did not take alcohol.” But the FDA appears to disagree, and after reviewing these same data, required that alcohol use be listed as a contraindication, he added. “I personally don’t think the data indicates that there is a major risk, but it is obviously open to interpretation.”

Dr. Apfel is a consultant to Sprout Pharmaceuticals and Valeant Pharmaceuticals. The studies were supported by Boehringer Ingelheim. Other support was provided by Valeant Pharmaceuticals. The data were presented at the 2016 American Urological Association annual meeting in San Diego.

[email protected]

On Twitter @whitneymcknight

A small number of women reported adverse events related to hypotension and syncope while taking flibanserin and drinking alcohol, an analysis of data from five phase III trials has shown.

Flibanserin is the first drug approved by the Food and Drug Administration for low female sexual desire in premenopausal women. When the FDA approved flibanserin in August 2015, the agency gave it a boxed warning contraindicating alcohol use with the drug because of a risk of severe hypotension and syncope. The FDA also directed Sprout Pharmaceuticals, who markets the drug as Addyi, to conduct postmarket studies into the relationship between hypotension- and syncope-related events concurrent with alcohol use.

Courtesy Sprout Pharmaceuticals

Flibanserin is metabolized through the CYP3A4 system, creating the potential for drug-drug and drug-alcohol interactions. A mixed agonist/antagonist for serotonin and dopamine receptors, flibanserin is taken orally at bedtime on a long-term basis, typically in doses of 100 mg.

Events related to hypotension and syncope include circulatory collapse, hypotension, loss of consciousness, orthostatic hypotension, syncope, vasovagal syncope, and light-headedness.

The industry-funded post hoc analysis included data from five phase III randomized, double-blind placebo-controlled studies of 3,448 premenopausal women. Of the 1,543 taking flibanserin 100 mg at bedtime for up to 24 weeks, 898 reported alcohol use at baseline. Six of these women reported a total of eight adverse events related to hypotension and syncope. In addition, two women who took flibanserin and reported they did not use alcohol had syncope-related events.

Of the 1,905 women taking a placebo, 1,212 reported alcohol use at baseline. Four of these women reported hypotension- and syncope-related adverse events. One woman in the placebo group who reported no alcohol use had two syncope-related adverse events.

Discontinuation rates due to hypotension or syncope among flibanserin users were virtually the same among those who did and did not report alcohol use: 1.8% vs. 1.7%. Among women in the placebo group, those who did not use alcohol had a discontinuation rate of 0.3%, while alcohol users who received placebo had a discontinuation rate of 0.15%.

“It is interesting to note that of the six alcohol users who took flibanserin and had syncopal or hypotensive episodes, four of them continued dosing and completed the study,” Dr. Stuart Apfel, the study’s lead author, said in an interview. “Of the two who did discontinue, one did so because of the syncopal event; the other did so because of somnolence, which is the most common side effect whether one takes alcohol with it or not.”

Dr. Apfel and his colleagues acknowledged that the analysis was limited by the fact that alcohol use was based on self-reports, rather than direct measurement. However, when asked if the drug is safe even if a woman has used alcohol more than she has reported, Dr. Apfel said he personally believes it’s safe, based on the data.

Although there is an increased risk of hypotension and/or syncope with the combination of alcohol use and flibanserin, Dr. Apfel said the risk “appears to be very small, and only moderately higher than [for] those who did not take alcohol.” But the FDA appears to disagree, and after reviewing these same data, required that alcohol use be listed as a contraindication, he added. “I personally don’t think the data indicates that there is a major risk, but it is obviously open to interpretation.”

Dr. Apfel is a consultant to Sprout Pharmaceuticals and Valeant Pharmaceuticals. The studies were supported by Boehringer Ingelheim. Other support was provided by Valeant Pharmaceuticals. The data were presented at the 2016 American Urological Association annual meeting in San Diego.

[email protected]

On Twitter @whitneymcknight

WASHINGTON – Now that the move to value-based care is in full swing, it’s time for physicians – especially those in small or solo practice – to get ready to change.

“This must be a completely overwhelming time for you. We get that,” Dr. Hoangmai Pham, director of Seamless Care Models Group at the Centers for Medicare & Medicaid Services’ Innovation Center, said at the annual meeting of the American College of Physicians. “We are trying to help you understand the landscape as much as possible.”

Merit Based Incentive Payments (MIPS) are one way the federal government is transitioning physician payments from volume-based to value-based medicine. The proposed rule to implement the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) indicates how Medicare officials intend for MIPS to streamline the three main quality metrics reporting systems currently in use – meaningful use, the patient quality reporting system, and value-based modifiers – along with clinical practice improvement activities, into one quality metrics reporting system to be used for reimbursements.

The CMS currently bases pay incentives on at least 90 different clinical practice improvement activities, Dr. Pham said in an interview. Practices that already incorporate these activities will find it easy to comply with MIPS, according to several analysts. Under the proposed rule, physician’s Medicare fees would be adjusted based on MIPS starting in 2019; adjustment are slated to range from a 3.5% cut to as much as a 4.5% increase. By 2024, Medicare pay may be cut – or increased – by as much as 9%.

Because Congress set up MIPS to be budget neutral, it is not intended to help physicians grow their bottom line, but to provide a bridge to the Brave New World of value-based care.

“MIPS helps to link fee-for-service payments with quality and value,” Dr. Pham said.

The ultimate goal of the Quality Performance Program – the name CMS has selected for the MACRA-mandated reforms – is for physicians to deliver higher quality care over volume of care. Carrots (potential rewards for high quality) and sticks (financial risk for low quality) will be employed.

APMs, ACOs, CPC+, oh my!

Once physicians get over the bridge to value-based medicine, alternative payment models (APMs) are one way to start reaping the rewards.

APMs offer an avenue to increased revenue (shared savings) but also require physicians to share risk with the government.

Another option is the recently announced Comprehensive Primary Care Plus (CPC+) accountable care organization under which physicians will be paid prospectively for meeting a variety of criteria.

The CMS is now soliciting bids from other insurers to participate in CPC+. Once the CMS knows which third party payers are willing to participate, and at what level and in which regions, practices will be able to apply. The CMS expects selected practices to begin participating by January 2017, Dr. Pham said in the interview.

These and other forms of patient-centered medical home-type ACOs, offered by the CMS or by private insurers, are intended to help practices develop payment structures that can be tailored to fit the unique characteristics of a given practice, including the specific types of populations served.

The proposed rule also notes that the CMS would like to offer what is known as Physician Focused Payment Models. These organizations might be included in the final rule if they meet three criteria: a clear plan for setting and meeting quality goals; an enumeration of the type of population that will be served; and what resources will be necessary at what cost.

After the final rule is posted, all physician-focused proposals will be reviewed by an advisory committee to the CMS, known as the Physician Focused Payment Model Technical Advisory Committee (PTAC).

Practice managers interested in developing this kind of model should pay close attention to pages 562 and 624 of the proposed rule document for more specific instructions, according to Dr . Kavita Patel, a fellow and managing director of the Engelberg Center for Health Care Reform at the Brookings Institute in Washington, D.C.

When asked about the likelihood of such a plan being approved – particularly since the final rule is expected in November 2016, with metrics from 2017 to be collected for the first round of quality performance payments in 2019 – Dr. Patel emphasized that while she was not speaking on behalf of the CMS, “the phrase they use is that they ‘want to keep the door open.’ I think that as long as you honor these criteria, the desire is to move these proposals through.” Still, she acknowledged, “The timing is extremely tight.”

The problem, she added, is that the criteria still need to be defined by the law, so it is hard to know if and when such proposals will be evaluated and approved. Meanwhile, all practices have the option of switching back to MIPS annually, but since the goal is to push physicians away from that model, as evidenced by the steeper penalties each year the law is in effect, this becomes less attractive an option.

Calls for calm

In some ways, according to Dr. Patel, this evolution in health care delivery should be seen as a good thing since “the fee-for-service model is not viable.”

And yet, an impact analysis from the CMS Office of the Actuary that was included with the proposed rule predicts that based on measurements to be taken in 2017, 87% of all solo practices will be negatively adjusted in 2019, the year MACRA goes into full effect. Nearly 70% of practices with between 2 and 9 physicians are predicted to be penalized, while about 60% of those with between 10 and 24 practices will be hit. Larger practices also are expected to be severely affected. For those with between 25 and 99 member physicians, nearly 45% will face negative adjustments and groups with 100 or more physicians will face a nearly 20% negative incursion, according to the analysis.

But before you sell your practice to the local hospital system or drop out of Medicare altogether, some analysts and officials advise against panic.

Robert B. Doherty, ACP senior vice president for governmental affairs and public policy, disputed the notion that the analysis is proof of the coming death of small practices. “I disagree with that. Essentially, the actuary was projecting using relatively low rates of participation [in the new value-based programs],” he said.

To that end, on May 11, acting CMS Administrator Andy Slavitt testified before the House Ways and Means Committee’s Subcommittee on Health that because those actuarial projections were based on data collected in 2014, they were not reflective of what he said was an uptick in quality measure reporting for 2015. Before the rule is finalized later this year, the actuarial tables would be updated to reflect the new data, he said.

That leaves plenty of time to advocate for feasible payment structures for practices of all sizes, Mr. Doherty said. “If we succeed in doing that, and I think there is some progress ... then I think there will be opportunities for smaller practices to get positive updates.”

Advocacy is not enough

Dr. Patel, a practicing internist in Washington, said that she agrees with this approach.

In addition to making constructive, written comments on the proposed rule, which closes on June 27, 2016, at 5 p.m. EDT, Dr. Patel said that taking steps to optimize available resources now, such as reporting quality measures, or using the chronic care management fee, are ways to ensure higher revenues in the future. “Think about ways to leverage your practice now in order to actually get on one of the advanced payment care models so you avoid being in that track that gets all that downward pressure,” she added.

Still, she said that advocacy may not be enough for some practices to stay solvent. “If the actuaries and CMS really believe that small practices are going to face these steep penalties and not be able to survive, then how we address that, such as through how we define alternative models that are broader [in scope] for practices to follow, has to actually be written by CMS into the final rule.”

No matter the type of ark you choose to build, particularly if yours is a small practice, you’ll have to create some kind of watertight vessel or else, said Dr. Patel, it is “going to be extremely hard to participate in the Medicare program.”

[email protected]

On Twitter @whitneymcknight

WASHINGTON – Now that the move to value-based care is in full swing, it’s time for physicians – especially those in small or solo practice – to get ready to change.

“This must be a completely overwhelming time for you. We get that,” Dr. Hoangmai Pham, director of Seamless Care Models Group at the Centers for Medicare & Medicaid Services’ Innovation Center, said at the annual meeting of the American College of Physicians. “We are trying to help you understand the landscape as much as possible.”

Merit Based Incentive Payments (MIPS) are one way the federal government is transitioning physician payments from volume-based to value-based medicine. The proposed rule to implement the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) indicates how Medicare officials intend for MIPS to streamline the three main quality metrics reporting systems currently in use – meaningful use, the patient quality reporting system, and value-based modifiers – along with clinical practice improvement activities, into one quality metrics reporting system to be used for reimbursements.

The CMS currently bases pay incentives on at least 90 different clinical practice improvement activities, Dr. Pham said in an interview. Practices that already incorporate these activities will find it easy to comply with MIPS, according to several analysts. Under the proposed rule, physician’s Medicare fees would be adjusted based on MIPS starting in 2019; adjustment are slated to range from a 3.5% cut to as much as a 4.5% increase. By 2024, Medicare pay may be cut – or increased – by as much as 9%.

Because Congress set up MIPS to be budget neutral, it is not intended to help physicians grow their bottom line, but to provide a bridge to the Brave New World of value-based care.

“MIPS helps to link fee-for-service payments with quality and value,” Dr. Pham said.

The ultimate goal of the Quality Performance Program – the name CMS has selected for the MACRA-mandated reforms – is for physicians to deliver higher quality care over volume of care. Carrots (potential rewards for high quality) and sticks (financial risk for low quality) will be employed.

APMs, ACOs, CPC+, oh my!

Once physicians get over the bridge to value-based medicine, alternative payment models (APMs) are one way to start reaping the rewards.

APMs offer an avenue to increased revenue (shared savings) but also require physicians to share risk with the government.

Another option is the recently announced Comprehensive Primary Care Plus (CPC+) accountable care organization under which physicians will be paid prospectively for meeting a variety of criteria.

The CMS is now soliciting bids from other insurers to participate in CPC+. Once the CMS knows which third party payers are willing to participate, and at what level and in which regions, practices will be able to apply. The CMS expects selected practices to begin participating by January 2017, Dr. Pham said in the interview.

These and other forms of patient-centered medical home-type ACOs, offered by the CMS or by private insurers, are intended to help practices develop payment structures that can be tailored to fit the unique characteristics of a given practice, including the specific types of populations served.

The proposed rule also notes that the CMS would like to offer what is known as Physician Focused Payment Models. These organizations might be included in the final rule if they meet three criteria: a clear plan for setting and meeting quality goals; an enumeration of the type of population that will be served; and what resources will be necessary at what cost.

After the final rule is posted, all physician-focused proposals will be reviewed by an advisory committee to the CMS, known as the Physician Focused Payment Model Technical Advisory Committee (PTAC).

Practice managers interested in developing this kind of model should pay close attention to pages 562 and 624 of the proposed rule document for more specific instructions, according to Dr . Kavita Patel, a fellow and managing director of the Engelberg Center for Health Care Reform at the Brookings Institute in Washington, D.C.

When asked about the likelihood of such a plan being approved – particularly since the final rule is expected in November 2016, with metrics from 2017 to be collected for the first round of quality performance payments in 2019 – Dr. Patel emphasized that while she was not speaking on behalf of the CMS, “the phrase they use is that they ‘want to keep the door open.’ I think that as long as you honor these criteria, the desire is to move these proposals through.” Still, she acknowledged, “The timing is extremely tight.”

The problem, she added, is that the criteria still need to be defined by the law, so it is hard to know if and when such proposals will be evaluated and approved. Meanwhile, all practices have the option of switching back to MIPS annually, but since the goal is to push physicians away from that model, as evidenced by the steeper penalties each year the law is in effect, this becomes less attractive an option.

Calls for calm

In some ways, according to Dr. Patel, this evolution in health care delivery should be seen as a good thing since “the fee-for-service model is not viable.”

And yet, an impact analysis from the CMS Office of the Actuary that was included with the proposed rule predicts that based on measurements to be taken in 2017, 87% of all solo practices will be negatively adjusted in 2019, the year MACRA goes into full effect. Nearly 70% of practices with between 2 and 9 physicians are predicted to be penalized, while about 60% of those with between 10 and 24 practices will be hit. Larger practices also are expected to be severely affected. For those with between 25 and 99 member physicians, nearly 45% will face negative adjustments and groups with 100 or more physicians will face a nearly 20% negative incursion, according to the analysis.

But before you sell your practice to the local hospital system or drop out of Medicare altogether, some analysts and officials advise against panic.

Robert B. Doherty, ACP senior vice president for governmental affairs and public policy, disputed the notion that the analysis is proof of the coming death of small practices. “I disagree with that. Essentially, the actuary was projecting using relatively low rates of participation [in the new value-based programs],” he said.

To that end, on May 11, acting CMS Administrator Andy Slavitt testified before the House Ways and Means Committee’s Subcommittee on Health that because those actuarial projections were based on data collected in 2014, they were not reflective of what he said was an uptick in quality measure reporting for 2015. Before the rule is finalized later this year, the actuarial tables would be updated to reflect the new data, he said.

That leaves plenty of time to advocate for feasible payment structures for practices of all sizes, Mr. Doherty said. “If we succeed in doing that, and I think there is some progress ... then I think there will be opportunities for smaller practices to get positive updates.”

Advocacy is not enough

Dr. Patel, a practicing internist in Washington, said that she agrees with this approach.

In addition to making constructive, written comments on the proposed rule, which closes on June 27, 2016, at 5 p.m. EDT, Dr. Patel said that taking steps to optimize available resources now, such as reporting quality measures, or using the chronic care management fee, are ways to ensure higher revenues in the future. “Think about ways to leverage your practice now in order to actually get on one of the advanced payment care models so you avoid being in that track that gets all that downward pressure,” she added.

Still, she said that advocacy may not be enough for some practices to stay solvent. “If the actuaries and CMS really believe that small practices are going to face these steep penalties and not be able to survive, then how we address that, such as through how we define alternative models that are broader [in scope] for practices to follow, has to actually be written by CMS into the final rule.”

No matter the type of ark you choose to build, particularly if yours is a small practice, you’ll have to create some kind of watertight vessel or else, said Dr. Patel, it is “going to be extremely hard to participate in the Medicare program.”

[email protected]

On Twitter @whitneymcknight

WASHINGTON – Now that the move to value-based care is in full swing, it’s time for physicians – especially those in small or solo practice – to get ready to change.

“This must be a completely overwhelming time for you. We get that,” Dr. Hoangmai Pham, director of Seamless Care Models Group at the Centers for Medicare & Medicaid Services’ Innovation Center, said at the annual meeting of the American College of Physicians. “We are trying to help you understand the landscape as much as possible.”

Merit Based Incentive Payments (MIPS) are one way the federal government is transitioning physician payments from volume-based to value-based medicine. The proposed rule to implement the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) indicates how Medicare officials intend for MIPS to streamline the three main quality metrics reporting systems currently in use – meaningful use, the patient quality reporting system, and value-based modifiers – along with clinical practice improvement activities, into one quality metrics reporting system to be used for reimbursements.

The CMS currently bases pay incentives on at least 90 different clinical practice improvement activities, Dr. Pham said in an interview. Practices that already incorporate these activities will find it easy to comply with MIPS, according to several analysts. Under the proposed rule, physician’s Medicare fees would be adjusted based on MIPS starting in 2019; adjustment are slated to range from a 3.5% cut to as much as a 4.5% increase. By 2024, Medicare pay may be cut – or increased – by as much as 9%.

Because Congress set up MIPS to be budget neutral, it is not intended to help physicians grow their bottom line, but to provide a bridge to the Brave New World of value-based care.

“MIPS helps to link fee-for-service payments with quality and value,” Dr. Pham said.

The ultimate goal of the Quality Performance Program – the name CMS has selected for the MACRA-mandated reforms – is for physicians to deliver higher quality care over volume of care. Carrots (potential rewards for high quality) and sticks (financial risk for low quality) will be employed.

APMs, ACOs, CPC+, oh my!

Once physicians get over the bridge to value-based medicine, alternative payment models (APMs) are one way to start reaping the rewards.

APMs offer an avenue to increased revenue (shared savings) but also require physicians to share risk with the government.

Another option is the recently announced Comprehensive Primary Care Plus (CPC+) accountable care organization under which physicians will be paid prospectively for meeting a variety of criteria.

The CMS is now soliciting bids from other insurers to participate in CPC+. Once the CMS knows which third party payers are willing to participate, and at what level and in which regions, practices will be able to apply. The CMS expects selected practices to begin participating by January 2017, Dr. Pham said in the interview.

These and other forms of patient-centered medical home-type ACOs, offered by the CMS or by private insurers, are intended to help practices develop payment structures that can be tailored to fit the unique characteristics of a given practice, including the specific types of populations served.

The proposed rule also notes that the CMS would like to offer what is known as Physician Focused Payment Models. These organizations might be included in the final rule if they meet three criteria: a clear plan for setting and meeting quality goals; an enumeration of the type of population that will be served; and what resources will be necessary at what cost.

After the final rule is posted, all physician-focused proposals will be reviewed by an advisory committee to the CMS, known as the Physician Focused Payment Model Technical Advisory Committee (PTAC).

Practice managers interested in developing this kind of model should pay close attention to pages 562 and 624 of the proposed rule document for more specific instructions, according to Dr . Kavita Patel, a fellow and managing director of the Engelberg Center for Health Care Reform at the Brookings Institute in Washington, D.C.

When asked about the likelihood of such a plan being approved – particularly since the final rule is expected in November 2016, with metrics from 2017 to be collected for the first round of quality performance payments in 2019 – Dr. Patel emphasized that while she was not speaking on behalf of the CMS, “the phrase they use is that they ‘want to keep the door open.’ I think that as long as you honor these criteria, the desire is to move these proposals through.” Still, she acknowledged, “The timing is extremely tight.”

The problem, she added, is that the criteria still need to be defined by the law, so it is hard to know if and when such proposals will be evaluated and approved. Meanwhile, all practices have the option of switching back to MIPS annually, but since the goal is to push physicians away from that model, as evidenced by the steeper penalties each year the law is in effect, this becomes less attractive an option.

Calls for calm

In some ways, according to Dr. Patel, this evolution in health care delivery should be seen as a good thing since “the fee-for-service model is not viable.”

And yet, an impact analysis from the CMS Office of the Actuary that was included with the proposed rule predicts that based on measurements to be taken in 2017, 87% of all solo practices will be negatively adjusted in 2019, the year MACRA goes into full effect. Nearly 70% of practices with between 2 and 9 physicians are predicted to be penalized, while about 60% of those with between 10 and 24 practices will be hit. Larger practices also are expected to be severely affected. For those with between 25 and 99 member physicians, nearly 45% will face negative adjustments and groups with 100 or more physicians will face a nearly 20% negative incursion, according to the analysis.

But before you sell your practice to the local hospital system or drop out of Medicare altogether, some analysts and officials advise against panic.

Robert B. Doherty, ACP senior vice president for governmental affairs and public policy, disputed the notion that the analysis is proof of the coming death of small practices. “I disagree with that. Essentially, the actuary was projecting using relatively low rates of participation [in the new value-based programs],” he said.

To that end, on May 11, acting CMS Administrator Andy Slavitt testified before the House Ways and Means Committee’s Subcommittee on Health that because those actuarial projections were based on data collected in 2014, they were not reflective of what he said was an uptick in quality measure reporting for 2015. Before the rule is finalized later this year, the actuarial tables would be updated to reflect the new data, he said.

That leaves plenty of time to advocate for feasible payment structures for practices of all sizes, Mr. Doherty said. “If we succeed in doing that, and I think there is some progress ... then I think there will be opportunities for smaller practices to get positive updates.”

Advocacy is not enough

Dr. Patel, a practicing internist in Washington, said that she agrees with this approach.

In addition to making constructive, written comments on the proposed rule, which closes on June 27, 2016, at 5 p.m. EDT, Dr. Patel said that taking steps to optimize available resources now, such as reporting quality measures, or using the chronic care management fee, are ways to ensure higher revenues in the future. “Think about ways to leverage your practice now in order to actually get on one of the advanced payment care models so you avoid being in that track that gets all that downward pressure,” she added.

Still, she said that advocacy may not be enough for some practices to stay solvent. “If the actuaries and CMS really believe that small practices are going to face these steep penalties and not be able to survive, then how we address that, such as through how we define alternative models that are broader [in scope] for practices to follow, has to actually be written by CMS into the final rule.”

No matter the type of ark you choose to build, particularly if yours is a small practice, you’ll have to create some kind of watertight vessel or else, said Dr. Patel, it is “going to be extremely hard to participate in the Medicare program.”

[email protected]

On Twitter @whitneymcknight

More pregnant women in the United States and its territories may be at risk for Zika virus–related birth complications than previously reported, according to the Centers for Disease Control and Prevention.

As of May 12, CDC officials were monitoring 279 pregnant women with laboratory evidence of possible Zika virus infection – 157 in U.S. states and 122 in U.S. territories, according to a report published in the Morbidity and Mortality Weekly Report (2016 May 20. doi: 10.15585/mmwr.mm6520e1).

CDC/ Division of Vector-borne Diseases

“We’ve learned a lot in the last 4 months, and now we know of reports of asymptomatic Zika infections linked to microcephaly, brain defects, and miscarriage,” Margaret Honein, Ph.D., chief of the birth defects branch at the CDC’s National Center for Birth Defects and Developmental Disabilities, said during a May 20 media briefing to announce enhanced tracking of the virus.

Recently published data indicating congenital defects in children born to mothers who had no recollection of ever having Zika-like symptoms spurred the CDC to widen its scope of data capture, Dr. Honein said.

Since February 2016, the CDC has been relying on data from the national arboviral disease surveillance system (ArboNET) to track Zika in pregnant women with symptoms of the Zika virus infection, or those with pregnancy complications consistent with the virus. Although ArboNET describes a subset of pregnancies at risk from Zika virus, it does not track actual congenital outcomes.

Now, federal health officials have created two registries solely dedicated to collecting data on birth outcomes among both symptomatic and asymptomatic women with any laboratory evidence of Zika virus infections. In the continental United States, there is the U.S. Zika Pregnancy Registry (USZPR). In Puerto Rico, there is the Zika Active Pregnancy Surveillance System (ZAPSS).

The 279 pregnant women currently being monitored reflect a broader group of pregnant women than numbers previously reported since it includes pregnant women who have any laboratory evidence of possible Zika virus infection, regardless of them being asymptomatic or whether they recalled ever having symptoms.

New figures on Zika infection in pregnancy will be posted on the CDC website each Thursday at noon EDT, and will reflect the previous week’s numbers.

“This reporting is in line with our recommendations for ongoing monitoring of pregnancies at risk for poor outcomes associated with Zika, based on our current understanding [of the virus],” Dr. Honein said. She recommended that pregnant women be tested for the virus at the start of prenatal care and again during the third trimester.The registry data will be used to determine those most at risk, characterize adverse Zika-related outcomes, and help officials plan for services needed by affected families, said Dr. Honein, encouraging all jurisdictions covered by the surveillance systems to participate in the data collection as quickly as possible.

Meanwhile, Dr. Honein said that the CDC is withholding specific information on known adverse birth outcomes in order to respect the affected families’ privacy, but did say that as of May 20, the CDC was aware of “less than a dozen adverse outcomes, including miscarriages and birth defects.”

Dr. Honein also declined to say how many of the cases reported to the registry involve sexual transmission of the virus versus actual contact with the Aedes aegypti mosquito.

[email protected]

On Twitter @whitneymcknight

More pregnant women in the United States and its territories may be at risk for Zika virus–related birth complications than previously reported, according to the Centers for Disease Control and Prevention.

As of May 12, CDC officials were monitoring 279 pregnant women with laboratory evidence of possible Zika virus infection – 157 in U.S. states and 122 in U.S. territories, according to a report published in the Morbidity and Mortality Weekly Report (2016 May 20. doi: 10.15585/mmwr.mm6520e1).

CDC/ Division of Vector-borne Diseases

“We’ve learned a lot in the last 4 months, and now we know of reports of asymptomatic Zika infections linked to microcephaly, brain defects, and miscarriage,” Margaret Honein, Ph.D., chief of the birth defects branch at the CDC’s National Center for Birth Defects and Developmental Disabilities, said during a May 20 media briefing to announce enhanced tracking of the virus.

Recently published data indicating congenital defects in children born to mothers who had no recollection of ever having Zika-like symptoms spurred the CDC to widen its scope of data capture, Dr. Honein said.

Since February 2016, the CDC has been relying on data from the national arboviral disease surveillance system (ArboNET) to track Zika in pregnant women with symptoms of the Zika virus infection, or those with pregnancy complications consistent with the virus. Although ArboNET describes a subset of pregnancies at risk from Zika virus, it does not track actual congenital outcomes.

Now, federal health officials have created two registries solely dedicated to collecting data on birth outcomes among both symptomatic and asymptomatic women with any laboratory evidence of Zika virus infections. In the continental United States, there is the U.S. Zika Pregnancy Registry (USZPR). In Puerto Rico, there is the Zika Active Pregnancy Surveillance System (ZAPSS).

The 279 pregnant women currently being monitored reflect a broader group of pregnant women than numbers previously reported since it includes pregnant women who have any laboratory evidence of possible Zika virus infection, regardless of them being asymptomatic or whether they recalled ever having symptoms.

New figures on Zika infection in pregnancy will be posted on the CDC website each Thursday at noon EDT, and will reflect the previous week’s numbers.

“This reporting is in line with our recommendations for ongoing monitoring of pregnancies at risk for poor outcomes associated with Zika, based on our current understanding [of the virus],” Dr. Honein said. She recommended that pregnant women be tested for the virus at the start of prenatal care and again during the third trimester.The registry data will be used to determine those most at risk, characterize adverse Zika-related outcomes, and help officials plan for services needed by affected families, said Dr. Honein, encouraging all jurisdictions covered by the surveillance systems to participate in the data collection as quickly as possible.

Meanwhile, Dr. Honein said that the CDC is withholding specific information on known adverse birth outcomes in order to respect the affected families’ privacy, but did say that as of May 20, the CDC was aware of “less than a dozen adverse outcomes, including miscarriages and birth defects.”

Dr. Honein also declined to say how many of the cases reported to the registry involve sexual transmission of the virus versus actual contact with the Aedes aegypti mosquito.

[email protected]

On Twitter @whitneymcknight

More pregnant women in the United States and its territories may be at risk for Zika virus–related birth complications than previously reported, according to the Centers for Disease Control and Prevention.

As of May 12, CDC officials were monitoring 279 pregnant women with laboratory evidence of possible Zika virus infection – 157 in U.S. states and 122 in U.S. territories, according to a report published in the Morbidity and Mortality Weekly Report (2016 May 20. doi: 10.15585/mmwr.mm6520e1).

CDC/ Division of Vector-borne Diseases

“We’ve learned a lot in the last 4 months, and now we know of reports of asymptomatic Zika infections linked to microcephaly, brain defects, and miscarriage,” Margaret Honein, Ph.D., chief of the birth defects branch at the CDC’s National Center for Birth Defects and Developmental Disabilities, said during a May 20 media briefing to announce enhanced tracking of the virus.

Recently published data indicating congenital defects in children born to mothers who had no recollection of ever having Zika-like symptoms spurred the CDC to widen its scope of data capture, Dr. Honein said.

Since February 2016, the CDC has been relying on data from the national arboviral disease surveillance system (ArboNET) to track Zika in pregnant women with symptoms of the Zika virus infection, or those with pregnancy complications consistent with the virus. Although ArboNET describes a subset of pregnancies at risk from Zika virus, it does not track actual congenital outcomes.

Now, federal health officials have created two registries solely dedicated to collecting data on birth outcomes among both symptomatic and asymptomatic women with any laboratory evidence of Zika virus infections. In the continental United States, there is the U.S. Zika Pregnancy Registry (USZPR). In Puerto Rico, there is the Zika Active Pregnancy Surveillance System (ZAPSS).

The 279 pregnant women currently being monitored reflect a broader group of pregnant women than numbers previously reported since it includes pregnant women who have any laboratory evidence of possible Zika virus infection, regardless of them being asymptomatic or whether they recalled ever having symptoms.

New figures on Zika infection in pregnancy will be posted on the CDC website each Thursday at noon EDT, and will reflect the previous week’s numbers.

“This reporting is in line with our recommendations for ongoing monitoring of pregnancies at risk for poor outcomes associated with Zika, based on our current understanding [of the virus],” Dr. Honein said. She recommended that pregnant women be tested for the virus at the start of prenatal care and again during the third trimester.The registry data will be used to determine those most at risk, characterize adverse Zika-related outcomes, and help officials plan for services needed by affected families, said Dr. Honein, encouraging all jurisdictions covered by the surveillance systems to participate in the data collection as quickly as possible.

Meanwhile, Dr. Honein said that the CDC is withholding specific information on known adverse birth outcomes in order to respect the affected families’ privacy, but did say that as of May 20, the CDC was aware of “less than a dozen adverse outcomes, including miscarriages and birth defects.”

Dr. Honein also declined to say how many of the cases reported to the registry involve sexual transmission of the virus versus actual contact with the Aedes aegypti mosquito.

[email protected]

On Twitter @whitneymcknight

ATLANTA – Telepsychiatry “in some ways is a force multiplier” because it expands the flexibility of when, where, and how physicians can provide integrated care to more patients, Dr. James (Jay) H. Shore said at the annual meeting of the American Psychiatric Association. But psychiatrists thinking about setting up a telepsychiatry practice must learn about regulations, technology, and administrative processes, he added.

In this video, Dr. Shore describes the regulatory landscape that exists for telepsychiatrists, how telepsychiatry fits into a collaborative care model, and reimbursement issues. He also discusses which services telepsychiatrists are not yet paid for and the regulatory landscape. In addition, he mentions specific training resources available to clinicians interested in learning how to incorporate telepsychiatry into their practices.

Dr. Shore, associate professor of psychiatry at the University of Colorado at Denver, is chair of the American Psychiatric Association’s Committee on Telepsychiatry.

[email protected]

On Twitter @whitneymcknight

ATLANTA – Telepsychiatry “in some ways is a force multiplier” because it expands the flexibility of when, where, and how physicians can provide integrated care to more patients, Dr. James (Jay) H. Shore said at the annual meeting of the American Psychiatric Association. But psychiatrists thinking about setting up a telepsychiatry practice must learn about regulations, technology, and administrative processes, he added.

In this video, Dr. Shore describes the regulatory landscape that exists for telepsychiatrists, how telepsychiatry fits into a collaborative care model, and reimbursement issues. He also discusses which services telepsychiatrists are not yet paid for and the regulatory landscape. In addition, he mentions specific training resources available to clinicians interested in learning how to incorporate telepsychiatry into their practices.

Dr. Shore, associate professor of psychiatry at the University of Colorado at Denver, is chair of the American Psychiatric Association’s Committee on Telepsychiatry.

[email protected]

On Twitter @whitneymcknight

ATLANTA – Telepsychiatry “in some ways is a force multiplier” because it expands the flexibility of when, where, and how physicians can provide integrated care to more patients, Dr. James (Jay) H. Shore said at the annual meeting of the American Psychiatric Association. But psychiatrists thinking about setting up a telepsychiatry practice must learn about regulations, technology, and administrative processes, he added.

In this video, Dr. Shore describes the regulatory landscape that exists for telepsychiatrists, how telepsychiatry fits into a collaborative care model, and reimbursement issues. He also discusses which services telepsychiatrists are not yet paid for and the regulatory landscape. In addition, he mentions specific training resources available to clinicians interested in learning how to incorporate telepsychiatry into their practices.

Dr. Shore, associate professor of psychiatry at the University of Colorado at Denver, is chair of the American Psychiatric Association’s Committee on Telepsychiatry.

[email protected]

On Twitter @whitneymcknight

ATLANTA – About half of all mental health professionals at all levels and in all practice settings can expect to be threatened by a patient at some point in their career, with as many as 40% sustaining a patient-inflicted injury, according to a researcher.

Despite these numbers, there exist few formal protocols for mental health personnel to learn how to protect themselves against the risk of being harmed by a patient.

Why this is, and what can be done to fill this void, has become an area of deep interest for Dr. Michael Knable, the executive director of the Sylvan C. Herman Foundation in Frederick, Md., a major underwriter for Clearview Communities’ residential treatment facilities for persons with mental illness, where Dr. Knable is also the medical director.“I really only got interested in this because of these two friends of mine who were killed [by patients],” Dr. Knable said in an interview at the annual meeting of the American Psychiatric Association.

His two friends were Dr. Wayne Fenton and Dr. Mark Lawrence, two Washington-based psychiatrists killed in their private offices by patients in 2006 and 2011, respectively.

“It’s true that the seriously mentally ill are more likely to be victimized than to be the victimizers, but it’s also true that, especially in acute settings like emergency rooms and hospitals, that they can be very violent,” Dr. Knable said in the interview.

Based on his research, Dr. Knable said the risks to practitioners include being physically threatened, stalked, sued, stabbed, and even shot to death, among other injuries. According to statistics from the Department of Justice, between 2004 and 2009, mental health workers were second only to law enforcement officers in sustaining on-the-job violence: 38 victims per 1,000 mental health workers, compared with 48 per 1,000 law enforcement officers.

Dr. Knable conducted a literature review of all published surveys of mental health professionals ranging from those with 4-year degrees, to social workers, to psychiatrists. He found that the typical profile of a mental health provider murdered by a patient is a female case worker in her 30s who has been shot to death. The typical patient perpetrator is a male, also in his 30s, who has a form of schizophrenia, a history of violence, and non-adherence to medication. More than half of these individuals also have a history of involuntary hospitalization.

“Our field attracts a lot of idealistic people who want to help others,” said Dr. Knable. “But until they’ve experienced [violence], they simply don’t evaluate the risks carefully enough.”

The National Institute of Mental Health’s Clinical Antipsychotic Treatment Intervention Effectiveness (CATIE) trial found that 19.1% of 1,410 patients with schizophrenia had a violent episode in the prior six months.

A meta-analysis of 110 studies of more than 45,000 patients with schizophrenia also found that nearly 20% had a history of violence, and review of registry data from Sweden showed that in 82,647 patients with schizophrenia, 6.5% of men and 1.4% of women had been convicted of a violent crime when not taking their medication. When they were taking their prescribed medications, crime rates fell by 45% in the cohort taking antipsychotics and 24% in those taking mood stabilizers.

Given these data, when asked why there are not more mandatory personal security training programs for mental health personnel, Dr. Knable said it comes down to a mix of naiveté and politics.

“The perception is that if you worry about this, you are stigmatizing the patient, and, to a certain extent, you are. But my desire is to be factual and to know what we’re really dealing with,” Dr. Knable said. Those in his profession most likely to underestimate the seriousness are those in private practice who “aren’t on the front lines” treating persons with serious mental illnesses like schizophrenia.

The national debate over gun control in the context of persons with mental illness also clouds the issue, he said. “People are afraid it will be stigmatizing and keep people out of treatment to say it, but if you have had an involuntary hospitalization, you should not be allowed to have a gun.”

In addition to taking a danger assessment of a patient in the pre-screening interview, Dr. Knable recommended clinicians set up their office so that there is a desk between them and the patient, and more importantly, that the patient is not between the clinician and the exit. Have an established escape route and consider installing cameras in the waiting area so you can see patients before they enter your office. Be aware of solo meetings such as after hours or on weekends. Above all, he said it was best to see potentially violent patients only in tandem with a member of that person’s family, a colleague, or even a security officer.“Before my friends were killed, I was just like everybody else. I just went to work and thought, ‘Well, you just have to be careful.’ I thought I had good instincts. But now, I think there is a lot of room for study and training on this issue.”

[email protected]

On Twitter @whitneymcknight

This article was updated May 17, 2016.

ATLANTA – About half of all mental health professionals at all levels and in all practice settings can expect to be threatened by a patient at some point in their career, with as many as 40% sustaining a patient-inflicted injury, according to a researcher.

Despite these numbers, there exist few formal protocols for mental health personnel to learn how to protect themselves against the risk of being harmed by a patient.

Why this is, and what can be done to fill this void, has become an area of deep interest for Dr. Michael Knable, the executive director of the Sylvan C. Herman Foundation in Frederick, Md., a major underwriter for Clearview Communities’ residential treatment facilities for persons with mental illness, where Dr. Knable is also the medical director.“I really only got interested in this because of these two friends of mine who were killed [by patients],” Dr. Knable said in an interview at the annual meeting of the American Psychiatric Association.

His two friends were Dr. Wayne Fenton and Dr. Mark Lawrence, two Washington-based psychiatrists killed in their private offices by patients in 2006 and 2011, respectively.

“It’s true that the seriously mentally ill are more likely to be victimized than to be the victimizers, but it’s also true that, especially in acute settings like emergency rooms and hospitals, that they can be very violent,” Dr. Knable said in the interview.

Based on his research, Dr. Knable said the risks to practitioners include being physically threatened, stalked, sued, stabbed, and even shot to death, among other injuries. According to statistics from the Department of Justice, between 2004 and 2009, mental health workers were second only to law enforcement officers in sustaining on-the-job violence: 38 victims per 1,000 mental health workers, compared with 48 per 1,000 law enforcement officers.

Dr. Knable conducted a literature review of all published surveys of mental health professionals ranging from those with 4-year degrees, to social workers, to psychiatrists. He found that the typical profile of a mental health provider murdered by a patient is a female case worker in her 30s who has been shot to death. The typical patient perpetrator is a male, also in his 30s, who has a form of schizophrenia, a history of violence, and non-adherence to medication. More than half of these individuals also have a history of involuntary hospitalization.

“Our field attracts a lot of idealistic people who want to help others,” said Dr. Knable. “But until they’ve experienced [violence], they simply don’t evaluate the risks carefully enough.”

The National Institute of Mental Health’s Clinical Antipsychotic Treatment Intervention Effectiveness (CATIE) trial found that 19.1% of 1,410 patients with schizophrenia had a violent episode in the prior six months.

A meta-analysis of 110 studies of more than 45,000 patients with schizophrenia also found that nearly 20% had a history of violence, and review of registry data from Sweden showed that in 82,647 patients with schizophrenia, 6.5% of men and 1.4% of women had been convicted of a violent crime when not taking their medication. When they were taking their prescribed medications, crime rates fell by 45% in the cohort taking antipsychotics and 24% in those taking mood stabilizers.

Given these data, when asked why there are not more mandatory personal security training programs for mental health personnel, Dr. Knable said it comes down to a mix of naiveté and politics.

“The perception is that if you worry about this, you are stigmatizing the patient, and, to a certain extent, you are. But my desire is to be factual and to know what we’re really dealing with,” Dr. Knable said. Those in his profession most likely to underestimate the seriousness are those in private practice who “aren’t on the front lines” treating persons with serious mental illnesses like schizophrenia.

The national debate over gun control in the context of persons with mental illness also clouds the issue, he said. “People are afraid it will be stigmatizing and keep people out of treatment to say it, but if you have had an involuntary hospitalization, you should not be allowed to have a gun.”

In addition to taking a danger assessment of a patient in the pre-screening interview, Dr. Knable recommended clinicians set up their office so that there is a desk between them and the patient, and more importantly, that the patient is not between the clinician and the exit. Have an established escape route and consider installing cameras in the waiting area so you can see patients before they enter your office. Be aware of solo meetings such as after hours or on weekends. Above all, he said it was best to see potentially violent patients only in tandem with a member of that person’s family, a colleague, or even a security officer.“Before my friends were killed, I was just like everybody else. I just went to work and thought, ‘Well, you just have to be careful.’ I thought I had good instincts. But now, I think there is a lot of room for study and training on this issue.”

[email protected]

On Twitter @whitneymcknight

This article was updated May 17, 2016.

ATLANTA – About half of all mental health professionals at all levels and in all practice settings can expect to be threatened by a patient at some point in their career, with as many as 40% sustaining a patient-inflicted injury, according to a researcher.

Despite these numbers, there exist few formal protocols for mental health personnel to learn how to protect themselves against the risk of being harmed by a patient.

Why this is, and what can be done to fill this void, has become an area of deep interest for Dr. Michael Knable, the executive director of the Sylvan C. Herman Foundation in Frederick, Md., a major underwriter for Clearview Communities’ residential treatment facilities for persons with mental illness, where Dr. Knable is also the medical director.“I really only got interested in this because of these two friends of mine who were killed [by patients],” Dr. Knable said in an interview at the annual meeting of the American Psychiatric Association.

His two friends were Dr. Wayne Fenton and Dr. Mark Lawrence, two Washington-based psychiatrists killed in their private offices by patients in 2006 and 2011, respectively.

“It’s true that the seriously mentally ill are more likely to be victimized than to be the victimizers, but it’s also true that, especially in acute settings like emergency rooms and hospitals, that they can be very violent,” Dr. Knable said in the interview.

Based on his research, Dr. Knable said the risks to practitioners include being physically threatened, stalked, sued, stabbed, and even shot to death, among other injuries. According to statistics from the Department of Justice, between 2004 and 2009, mental health workers were second only to law enforcement officers in sustaining on-the-job violence: 38 victims per 1,000 mental health workers, compared with 48 per 1,000 law enforcement officers.

Dr. Knable conducted a literature review of all published surveys of mental health professionals ranging from those with 4-year degrees, to social workers, to psychiatrists. He found that the typical profile of a mental health provider murdered by a patient is a female case worker in her 30s who has been shot to death. The typical patient perpetrator is a male, also in his 30s, who has a form of schizophrenia, a history of violence, and non-adherence to medication. More than half of these individuals also have a history of involuntary hospitalization.

“Our field attracts a lot of idealistic people who want to help others,” said Dr. Knable. “But until they’ve experienced [violence], they simply don’t evaluate the risks carefully enough.”

The National Institute of Mental Health’s Clinical Antipsychotic Treatment Intervention Effectiveness (CATIE) trial found that 19.1% of 1,410 patients with schizophrenia had a violent episode in the prior six months.

A meta-analysis of 110 studies of more than 45,000 patients with schizophrenia also found that nearly 20% had a history of violence, and review of registry data from Sweden showed that in 82,647 patients with schizophrenia, 6.5% of men and 1.4% of women had been convicted of a violent crime when not taking their medication. When they were taking their prescribed medications, crime rates fell by 45% in the cohort taking antipsychotics and 24% in those taking mood stabilizers.

Given these data, when asked why there are not more mandatory personal security training programs for mental health personnel, Dr. Knable said it comes down to a mix of naiveté and politics.

“The perception is that if you worry about this, you are stigmatizing the patient, and, to a certain extent, you are. But my desire is to be factual and to know what we’re really dealing with,” Dr. Knable said. Those in his profession most likely to underestimate the seriousness are those in private practice who “aren’t on the front lines” treating persons with serious mental illnesses like schizophrenia.

The national debate over gun control in the context of persons with mental illness also clouds the issue, he said. “People are afraid it will be stigmatizing and keep people out of treatment to say it, but if you have had an involuntary hospitalization, you should not be allowed to have a gun.”

In addition to taking a danger assessment of a patient in the pre-screening interview, Dr. Knable recommended clinicians set up their office so that there is a desk between them and the patient, and more importantly, that the patient is not between the clinician and the exit. Have an established escape route and consider installing cameras in the waiting area so you can see patients before they enter your office. Be aware of solo meetings such as after hours or on weekends. Above all, he said it was best to see potentially violent patients only in tandem with a member of that person’s family, a colleague, or even a security officer.“Before my friends were killed, I was just like everybody else. I just went to work and thought, ‘Well, you just have to be careful.’ I thought I had good instincts. But now, I think there is a lot of room for study and training on this issue.”

[email protected]

On Twitter @whitneymcknight

This article was updated May 17, 2016.