Medicare fee schedule: Proposed pay bump falls short of promise

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Physicians will likely see a 0.31% uptick in their Medicare payments in 2018 and not the 0.5% promised in the Medicare Access and CHIP Reauthorization Act.

Officials at the Centers for Medicare & Medicaid Services were not able to find adequate funding in so-called misvalued codes to support the larger increase, as required by law, according to the proposed Medicare physician fee schedule for 2018.

TheaDesign/Thinkstock
CMS also failed to hit its misvalued code target in 2016, resulting in a 0.18% across-the-board reduction to the physician fee schedule in 2017 instead of the statutorily promised 0.5% increase.

Other provisions in the proposed Medicare physician fee schedule may be more palatable than the petite pay raise.

The proposal would roll back data reporting requirements of the Physician Quality Reporting System (PQRS), to better align them with the new Quality Payment Program (QPP), and will waive half of penalties assessed for not meeting PQRS requirements in 2016.

“We are proposing these changes based on stakeholder feedback and to better align with the MIPS [Merit-based Incentive Payment System track of the QPP] data submission requirements for the quality performance category,” according to a CMS fact sheet on the proposed fee schedule.

“This will allow some physicians who attempted to report for the 2016 performance period to avoid penalties and better align PQRS with MIPS as physicians transition to QPP,” officials from the American College of Physicians said in a statement.

Other physician organizations said they believed the proposal did not go far enough.

“While the reductions in penalties represent a move in the right direction, the [American College of Rheumatology] believes CMS should establish a value modifier adjustment of zero for 2018,” ACR officials said in a statement. “This would align with the agency’s policy to ‘zero out’ the impact of the resource use component of the Merit-based Incentive Payment System in 2019, the successor to the value modifier program. This provides additional time to continue refining the cost measures and gives physicians more time to understand the program.”

The proposed fee schedule also would delay implementation of the appropriate use criteria (AUC) for imaging services, a program that would deny payments for imaging services unless the ordering physician consulted the appropriate use criteria.

The American Medical Association “appreciates CMS’ decision to postpone the implementation of this requirement until 2019 and to make the first year an opportunity for testing and education where consultation would not be required as a condition of payment for imaging services,” according to a statement.

“We also applaud the proposed delay in implementing AUC for diagnostic imaging studies,” ACR said in its statement. “We will be gauging the readiness of our members to use clinical support systems. ... We support simplifying and phasing-in the program requirements. The ACR also strongly supports larger exemptions to the program,” such as physicians in small groups and rural and underserved areas.

The proposed fee schedule also seeks feedback from physicians and organizations on how Medicare Part B pays for biosimilars. Under the 2016 fee schedule, the average sales prices (ASPs) for all biosimilar products assigned to the same reference product are included in the same CPT code, meaning the ASPs for all biosimilars of a common reference product are used to determine a single reimbursement rate.

That CMS is looking deeper at this is being seen as a plus.

Biosimilars “tied to the same reference product may not share all indications with one another or the reference product [and] a blended payment model may cause significant confusion in a multitiered biosimilars market that may include both interchangeable and noninterchangeable products,” the Biosimilars Forum said in a statement.

The current situation “may lead to decreased physician confidence in how they are reimbursed and also dramatically reduce the investment in the development of biosimilars and thereby limit treatment options available to patients.”

Both the Biosimilars Forum and the ACR support unique codes for each biosimilar.

“Physicians can better track and monitor their effectiveness and ensure adequate pharmacovigilance in the area of biosimilars” by employing unique codes, according to ACR officials.

“AGA agrees that there should be separate, unique codes for biosimilars; however, we have additional concerns regarding gastroenterological disorders. Specifically, inflammatory bowel disease (IBD) carries unique risks with regard to immunogenicity and currently there is a paucity of clinical data for biosimilars in people with IBD. Real-world use is often the first experience in IBD for these products.”

The fee schedule proposal also would expand the Medicare Diabetes Prevention Program (DPP), currently a demonstration project, taking it nationwide in 2018. The proposal outlines the payment structure and supplier enrollment requirements and compliance standards, as well as beneficiary engagement incentives.

Physicians would be paid based on performance goals being met by patients, including meeting certain numbers of service and maintenance sessions with the program as well as achieving specific weight loss goals. For beneficiaries who are able to lose at least 5% of body weight, physicians could receive up to $810. If that weight loss goal is not achieved, the most a physician could receive is $125, according to a CMS fact sheet. Currently, DPP can be employed only via office visit; however, the proposal would allow virtual make-up sessions.

“The new proposal provides more flexibility to DPP providers in supporting patient engagement and attendance and by making performance-based payments available if patients meet weight-loss targets over longer periods of time,” according to the AMA.

The fee schedule also proposes more telemedicine coverage, specifically for counseling to discuss the need for lung cancer screening, including eligibility determination and shared decision making, as well psychotherapy for crisis, with codes for the first 60 minutes of intervention and a separate code for each additional 30 minutes. Four add-on codes have been proposed to supplement existing codes that cover interactive complexity, chronic care management services, and health risk assessment.

For clinicians providing behavioral health services, CMS is proposing an increased payment for providing face-to-face office-based services that better reflects overhead expenses.

The final rule is expected in early November.
 

[email protected]

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Physicians will likely see a 0.31% uptick in their Medicare payments in 2018 and not the 0.5% promised in the Medicare Access and CHIP Reauthorization Act.

Officials at the Centers for Medicare & Medicaid Services were not able to find adequate funding in so-called misvalued codes to support the larger increase, as required by law, according to the proposed Medicare physician fee schedule for 2018.

TheaDesign/Thinkstock
CMS also failed to hit its misvalued code target in 2016, resulting in a 0.18% across-the-board reduction to the physician fee schedule in 2017 instead of the statutorily promised 0.5% increase.

Other provisions in the proposed Medicare physician fee schedule may be more palatable than the petite pay raise.

The proposal would roll back data reporting requirements of the Physician Quality Reporting System (PQRS), to better align them with the new Quality Payment Program (QPP), and will waive half of penalties assessed for not meeting PQRS requirements in 2016.

“We are proposing these changes based on stakeholder feedback and to better align with the MIPS [Merit-based Incentive Payment System track of the QPP] data submission requirements for the quality performance category,” according to a CMS fact sheet on the proposed fee schedule.

“This will allow some physicians who attempted to report for the 2016 performance period to avoid penalties and better align PQRS with MIPS as physicians transition to QPP,” officials from the American College of Physicians said in a statement.

Other physician organizations said they believed the proposal did not go far enough.

“While the reductions in penalties represent a move in the right direction, the [American College of Rheumatology] believes CMS should establish a value modifier adjustment of zero for 2018,” ACR officials said in a statement. “This would align with the agency’s policy to ‘zero out’ the impact of the resource use component of the Merit-based Incentive Payment System in 2019, the successor to the value modifier program. This provides additional time to continue refining the cost measures and gives physicians more time to understand the program.”

The proposed fee schedule also would delay implementation of the appropriate use criteria (AUC) for imaging services, a program that would deny payments for imaging services unless the ordering physician consulted the appropriate use criteria.

The American Medical Association “appreciates CMS’ decision to postpone the implementation of this requirement until 2019 and to make the first year an opportunity for testing and education where consultation would not be required as a condition of payment for imaging services,” according to a statement.

“We also applaud the proposed delay in implementing AUC for diagnostic imaging studies,” ACR said in its statement. “We will be gauging the readiness of our members to use clinical support systems. ... We support simplifying and phasing-in the program requirements. The ACR also strongly supports larger exemptions to the program,” such as physicians in small groups and rural and underserved areas.

The proposed fee schedule also seeks feedback from physicians and organizations on how Medicare Part B pays for biosimilars. Under the 2016 fee schedule, the average sales prices (ASPs) for all biosimilar products assigned to the same reference product are included in the same CPT code, meaning the ASPs for all biosimilars of a common reference product are used to determine a single reimbursement rate.

That CMS is looking deeper at this is being seen as a plus.

Biosimilars “tied to the same reference product may not share all indications with one another or the reference product [and] a blended payment model may cause significant confusion in a multitiered biosimilars market that may include both interchangeable and noninterchangeable products,” the Biosimilars Forum said in a statement.

The current situation “may lead to decreased physician confidence in how they are reimbursed and also dramatically reduce the investment in the development of biosimilars and thereby limit treatment options available to patients.”

Both the Biosimilars Forum and the ACR support unique codes for each biosimilar.

“Physicians can better track and monitor their effectiveness and ensure adequate pharmacovigilance in the area of biosimilars” by employing unique codes, according to ACR officials.

“AGA agrees that there should be separate, unique codes for biosimilars; however, we have additional concerns regarding gastroenterological disorders. Specifically, inflammatory bowel disease (IBD) carries unique risks with regard to immunogenicity and currently there is a paucity of clinical data for biosimilars in people with IBD. Real-world use is often the first experience in IBD for these products.”

The fee schedule proposal also would expand the Medicare Diabetes Prevention Program (DPP), currently a demonstration project, taking it nationwide in 2018. The proposal outlines the payment structure and supplier enrollment requirements and compliance standards, as well as beneficiary engagement incentives.

Physicians would be paid based on performance goals being met by patients, including meeting certain numbers of service and maintenance sessions with the program as well as achieving specific weight loss goals. For beneficiaries who are able to lose at least 5% of body weight, physicians could receive up to $810. If that weight loss goal is not achieved, the most a physician could receive is $125, according to a CMS fact sheet. Currently, DPP can be employed only via office visit; however, the proposal would allow virtual make-up sessions.

“The new proposal provides more flexibility to DPP providers in supporting patient engagement and attendance and by making performance-based payments available if patients meet weight-loss targets over longer periods of time,” according to the AMA.

The fee schedule also proposes more telemedicine coverage, specifically for counseling to discuss the need for lung cancer screening, including eligibility determination and shared decision making, as well psychotherapy for crisis, with codes for the first 60 minutes of intervention and a separate code for each additional 30 minutes. Four add-on codes have been proposed to supplement existing codes that cover interactive complexity, chronic care management services, and health risk assessment.

For clinicians providing behavioral health services, CMS is proposing an increased payment for providing face-to-face office-based services that better reflects overhead expenses.

The final rule is expected in early November.
 

[email protected]

 

Physicians will likely see a 0.31% uptick in their Medicare payments in 2018 and not the 0.5% promised in the Medicare Access and CHIP Reauthorization Act.

Officials at the Centers for Medicare & Medicaid Services were not able to find adequate funding in so-called misvalued codes to support the larger increase, as required by law, according to the proposed Medicare physician fee schedule for 2018.

TheaDesign/Thinkstock
CMS also failed to hit its misvalued code target in 2016, resulting in a 0.18% across-the-board reduction to the physician fee schedule in 2017 instead of the statutorily promised 0.5% increase.

Other provisions in the proposed Medicare physician fee schedule may be more palatable than the petite pay raise.

The proposal would roll back data reporting requirements of the Physician Quality Reporting System (PQRS), to better align them with the new Quality Payment Program (QPP), and will waive half of penalties assessed for not meeting PQRS requirements in 2016.

“We are proposing these changes based on stakeholder feedback and to better align with the MIPS [Merit-based Incentive Payment System track of the QPP] data submission requirements for the quality performance category,” according to a CMS fact sheet on the proposed fee schedule.

“This will allow some physicians who attempted to report for the 2016 performance period to avoid penalties and better align PQRS with MIPS as physicians transition to QPP,” officials from the American College of Physicians said in a statement.

Other physician organizations said they believed the proposal did not go far enough.

“While the reductions in penalties represent a move in the right direction, the [American College of Rheumatology] believes CMS should establish a value modifier adjustment of zero for 2018,” ACR officials said in a statement. “This would align with the agency’s policy to ‘zero out’ the impact of the resource use component of the Merit-based Incentive Payment System in 2019, the successor to the value modifier program. This provides additional time to continue refining the cost measures and gives physicians more time to understand the program.”

The proposed fee schedule also would delay implementation of the appropriate use criteria (AUC) for imaging services, a program that would deny payments for imaging services unless the ordering physician consulted the appropriate use criteria.

The American Medical Association “appreciates CMS’ decision to postpone the implementation of this requirement until 2019 and to make the first year an opportunity for testing and education where consultation would not be required as a condition of payment for imaging services,” according to a statement.

“We also applaud the proposed delay in implementing AUC for diagnostic imaging studies,” ACR said in its statement. “We will be gauging the readiness of our members to use clinical support systems. ... We support simplifying and phasing-in the program requirements. The ACR also strongly supports larger exemptions to the program,” such as physicians in small groups and rural and underserved areas.

The proposed fee schedule also seeks feedback from physicians and organizations on how Medicare Part B pays for biosimilars. Under the 2016 fee schedule, the average sales prices (ASPs) for all biosimilar products assigned to the same reference product are included in the same CPT code, meaning the ASPs for all biosimilars of a common reference product are used to determine a single reimbursement rate.

That CMS is looking deeper at this is being seen as a plus.

Biosimilars “tied to the same reference product may not share all indications with one another or the reference product [and] a blended payment model may cause significant confusion in a multitiered biosimilars market that may include both interchangeable and noninterchangeable products,” the Biosimilars Forum said in a statement.

The current situation “may lead to decreased physician confidence in how they are reimbursed and also dramatically reduce the investment in the development of biosimilars and thereby limit treatment options available to patients.”

Both the Biosimilars Forum and the ACR support unique codes for each biosimilar.

“Physicians can better track and monitor their effectiveness and ensure adequate pharmacovigilance in the area of biosimilars” by employing unique codes, according to ACR officials.

“AGA agrees that there should be separate, unique codes for biosimilars; however, we have additional concerns regarding gastroenterological disorders. Specifically, inflammatory bowel disease (IBD) carries unique risks with regard to immunogenicity and currently there is a paucity of clinical data for biosimilars in people with IBD. Real-world use is often the first experience in IBD for these products.”

The fee schedule proposal also would expand the Medicare Diabetes Prevention Program (DPP), currently a demonstration project, taking it nationwide in 2018. The proposal outlines the payment structure and supplier enrollment requirements and compliance standards, as well as beneficiary engagement incentives.

Physicians would be paid based on performance goals being met by patients, including meeting certain numbers of service and maintenance sessions with the program as well as achieving specific weight loss goals. For beneficiaries who are able to lose at least 5% of body weight, physicians could receive up to $810. If that weight loss goal is not achieved, the most a physician could receive is $125, according to a CMS fact sheet. Currently, DPP can be employed only via office visit; however, the proposal would allow virtual make-up sessions.

“The new proposal provides more flexibility to DPP providers in supporting patient engagement and attendance and by making performance-based payments available if patients meet weight-loss targets over longer periods of time,” according to the AMA.

The fee schedule also proposes more telemedicine coverage, specifically for counseling to discuss the need for lung cancer screening, including eligibility determination and shared decision making, as well psychotherapy for crisis, with codes for the first 60 minutes of intervention and a separate code for each additional 30 minutes. Four add-on codes have been proposed to supplement existing codes that cover interactive complexity, chronic care management services, and health risk assessment.

For clinicians providing behavioral health services, CMS is proposing an increased payment for providing face-to-face office-based services that better reflects overhead expenses.

The final rule is expected in early November.
 

[email protected]

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Genital psoriasis is the worst: Patients sound off

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– The great majority of patients with genital psoriasis say their symptoms in the genital area are worse than elsewhere on the body, Kim A. Meeuwis, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.

She presented a qualitative study in which 20 patients with longstanding genital psoriasis sounded off, sharing their perspectives on the disease in one-on-one, semistructured, face-to-face interviews.

Bruce Jancin/Frontline Medical News
Dr. Kim Meeuwis
“It’s not the case that every patient with genital psoriasis experiences worse symptoms, but by far, most patients report that several aspects of psoriasis – including intensified pain and discomfort – are worse in or unique to the genital area,” said Dr. Meeuwis, a dermatologist at Radboud University Medical Center in Nijmegen, the Netherlands.

Genital psoriasis is common. Epidemiologic studies show 30%-60% of psoriasis patients experience genital involvement at some point in the course of their disease. Yet patients seldom discuss their genital psoriasis with their physicians, and the patient perspective on how the experience of genital psoriasis differs from that of having psoriasis at other locations has been addressed only sparsely in the literature. This lack of attention was the impetus for the current study, she explained.

The 20 participants in the study had an average 18-year history of plaque psoriasis, with an average 7.5-year history of genital involvement. The genital psoriasis was rated moderate or severe in 70% of subjects at the time of the study.

The most commonly reported symptoms of genital psoriasis were itch and discomfort, each of which was cited by all study participants. This was followed by erythema, cited by 95%; stinging and burning, also cited by 95%; pain, cited by 85%; scaling, by 75%; and cracking, by 30%.

Of the patients in the study, 85% reported that their pain and/or discomfort were worse in the genital area than at other sites, and 10% said they were highly self-conscious about their genital psoriasis because others had misidentified them as having a sexually transmitted infection.

Since this was a qualitative study, Dr. Meeuwis provided representative quotes from several patients, including one who asserted, “I really only have discomfort on my psoriasis on the rest of my body ... in my genitals is the only place that actually has pain, or the itching is ... really, really bad.”

Dr. Meeuwis said the study results hold an important lesson for physicians who treat psoriasis: “Due to differences in patient experiences between genital and nongenital skin, it’s really important to make time for the specific evaluation of genital involvement in taking care of patients with psoriasis – and to be sure to ask about it.”

Dr. Meeuwis reported serving as a consultant to Eli Lilly, which sponsored the study, as well as being on an advisory board to Beiersdorf.
 

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– The great majority of patients with genital psoriasis say their symptoms in the genital area are worse than elsewhere on the body, Kim A. Meeuwis, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.

She presented a qualitative study in which 20 patients with longstanding genital psoriasis sounded off, sharing their perspectives on the disease in one-on-one, semistructured, face-to-face interviews.

Bruce Jancin/Frontline Medical News
Dr. Kim Meeuwis
“It’s not the case that every patient with genital psoriasis experiences worse symptoms, but by far, most patients report that several aspects of psoriasis – including intensified pain and discomfort – are worse in or unique to the genital area,” said Dr. Meeuwis, a dermatologist at Radboud University Medical Center in Nijmegen, the Netherlands.

Genital psoriasis is common. Epidemiologic studies show 30%-60% of psoriasis patients experience genital involvement at some point in the course of their disease. Yet patients seldom discuss their genital psoriasis with their physicians, and the patient perspective on how the experience of genital psoriasis differs from that of having psoriasis at other locations has been addressed only sparsely in the literature. This lack of attention was the impetus for the current study, she explained.

The 20 participants in the study had an average 18-year history of plaque psoriasis, with an average 7.5-year history of genital involvement. The genital psoriasis was rated moderate or severe in 70% of subjects at the time of the study.

The most commonly reported symptoms of genital psoriasis were itch and discomfort, each of which was cited by all study participants. This was followed by erythema, cited by 95%; stinging and burning, also cited by 95%; pain, cited by 85%; scaling, by 75%; and cracking, by 30%.

Of the patients in the study, 85% reported that their pain and/or discomfort were worse in the genital area than at other sites, and 10% said they were highly self-conscious about their genital psoriasis because others had misidentified them as having a sexually transmitted infection.

Since this was a qualitative study, Dr. Meeuwis provided representative quotes from several patients, including one who asserted, “I really only have discomfort on my psoriasis on the rest of my body ... in my genitals is the only place that actually has pain, or the itching is ... really, really bad.”

Dr. Meeuwis said the study results hold an important lesson for physicians who treat psoriasis: “Due to differences in patient experiences between genital and nongenital skin, it’s really important to make time for the specific evaluation of genital involvement in taking care of patients with psoriasis – and to be sure to ask about it.”

Dr. Meeuwis reported serving as a consultant to Eli Lilly, which sponsored the study, as well as being on an advisory board to Beiersdorf.
 

 

– The great majority of patients with genital psoriasis say their symptoms in the genital area are worse than elsewhere on the body, Kim A. Meeuwis, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.

She presented a qualitative study in which 20 patients with longstanding genital psoriasis sounded off, sharing their perspectives on the disease in one-on-one, semistructured, face-to-face interviews.

Bruce Jancin/Frontline Medical News
Dr. Kim Meeuwis
“It’s not the case that every patient with genital psoriasis experiences worse symptoms, but by far, most patients report that several aspects of psoriasis – including intensified pain and discomfort – are worse in or unique to the genital area,” said Dr. Meeuwis, a dermatologist at Radboud University Medical Center in Nijmegen, the Netherlands.

Genital psoriasis is common. Epidemiologic studies show 30%-60% of psoriasis patients experience genital involvement at some point in the course of their disease. Yet patients seldom discuss their genital psoriasis with their physicians, and the patient perspective on how the experience of genital psoriasis differs from that of having psoriasis at other locations has been addressed only sparsely in the literature. This lack of attention was the impetus for the current study, she explained.

The 20 participants in the study had an average 18-year history of plaque psoriasis, with an average 7.5-year history of genital involvement. The genital psoriasis was rated moderate or severe in 70% of subjects at the time of the study.

The most commonly reported symptoms of genital psoriasis were itch and discomfort, each of which was cited by all study participants. This was followed by erythema, cited by 95%; stinging and burning, also cited by 95%; pain, cited by 85%; scaling, by 75%; and cracking, by 30%.

Of the patients in the study, 85% reported that their pain and/or discomfort were worse in the genital area than at other sites, and 10% said they were highly self-conscious about their genital psoriasis because others had misidentified them as having a sexually transmitted infection.

Since this was a qualitative study, Dr. Meeuwis provided representative quotes from several patients, including one who asserted, “I really only have discomfort on my psoriasis on the rest of my body ... in my genitals is the only place that actually has pain, or the itching is ... really, really bad.”

Dr. Meeuwis said the study results hold an important lesson for physicians who treat psoriasis: “Due to differences in patient experiences between genital and nongenital skin, it’s really important to make time for the specific evaluation of genital involvement in taking care of patients with psoriasis – and to be sure to ask about it.”

Dr. Meeuwis reported serving as a consultant to Eli Lilly, which sponsored the study, as well as being on an advisory board to Beiersdorf.
 

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Key clinical point: Most patients with genital psoriasis say their symptoms are worse there than elsewhere on the body.

Major finding: Of the participants in a study of genital psoriasis, 100% reported that a hallmark of their genital disease was itching and discomfort.

Data source: A qualitative study that involved one-on-one interviews with 20 patients with genital psoriasis, who shared their experiences as to how genital involvement differs from their psoriasis elsewhere.

Disclosures: The study was sponsored by Eli Lilly. The presenter reported serving as a consultant to the company.

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Advance care planning benefit presents challenges

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When Donna Sweet, MD, sees patients for routine exams, death and dying are often the furthest thing from their minds. Regardless of age or health status, however, Dr. Sweet regularly asks patients about end-of-life care and whether they’ve considered their options.

In the past, physicians had to be creative in how they coded for such conversations, but Medicare’s newish advance care planning benefit is changing that.

Dr. Donna Sweet
“I’ve found patients to be appreciative of having it brought up when they’re not terribly ill,” says Dr. Sweet, professor of medicine at the University of Kansas, Wichita. “That way, they can go home and discuss with spouses and kids. It’s nice to be reimbursed for something that needs to be done.”

Staring in 2016, the Centers for Medicare & Medicaid Services began reimbursing physicians for advance care planning discussions with the approval of two new codes: 99497 and 99498. The codes pay about $86 for the first 30-minutes of a face-to-face conversation with a patient, family member, and/or surrogate and about $75 for additional sessions. Services can be furnished in both inpatient and ambulatory settings, and payment is not limited to particular physician specialties.

Dr. Sweet said that she uses these codes a couple times a week when patients visit for reasons such as routine hypertension or diabetes exams or annual Medicare wellness visits. To broach the subject, Dr. Sweet said it helps to have literature about advance care planning in the room that patients can review.

“It’s just a matter of bringing it up,” she said. “Considering some of the other codes, the advance care planning code is really pretty simple.”

However, doctors like Dr. Sweet appear to be in the minority when it comes to providing this service. Of the nearly 57 million beneficiaries enrolled in Medicare at the end of 2016, only about 1% received advance care planning sessions, according to analysis of Medicare data posted by Kaiser Health News. Nationwide, health providers submitted about $93 million in charges, of which $43 million was paid by Medicare.

Dr. Mary M. Newman
“It takes awhile to learn how to use new codes,” said Mary M. Newman, MD, an internist based in Lutherville, Md., and the American College of Physician’s adviser to the American Medical Association Relative Scale Value Update Committee. “A lot of people simply do not have the time to learn how to code something they haven’t coded before. They have to look it up, and they have to make sure they are complying with the new guidelines. I can see where this is something that’s going to take awhile to learn how to do.”
 

Challenges deter conversations

During a recent visit with a 72-year-old cancer patient, Bridget Fahy, MD, a surgical oncologist at the University of New Mexico, Albuquerque, spent time discussing advance directives and the importance of naming a surrogate decision maker. Dr. Fahy had treated the patient for two different cancers over the course of 4 years, and he was now diagnosed with a third, she recalled during an interview. Figuring out an advance care plan, though, proved complicated: The man was not married, had no children, and had no family members who lived in the state.

Although Dr. Fahy was aware of the Medicare advance care planning codes, she did not bill the session as such.

“Even in the course of having that conversation, I’m more apt to bill on time than I am specifically to meet the Medicare requirements for the documentation for [the benefit],” she said.

Dr. Bridget Fahy
Time constraints and documentation hurdles act as barriers to using the advance care planing codes, Dr. Fahy said. During a typical new patient visit, for instance, surgeons already have a significant volume of information to discuss regarding evaluation and surgical management of the patient’s condition; often, there is not enough time to discuss advance care planning, she said.

“There are two pieces required to take advantage of the advance care planning benefit code: having the conversation and documenting it,” Dr. Fahy noted. “What I write at the end of a resident note or an advanced practice provider note is going to be more focused on the counseling I had with the patient about their condition, the evaluation, and what the treatment plan is going to be. For surgeons to utilize the advance care planning codes, they have to have knowledge of the code, which many do not; they must know the requirements for documenting the conversation; and they have to have the time needed to have the conversation while also addressing all of the surgery-specific issues that need to be covered during the visit. There are a number of hurdles to overcome.”

Danielle B. Scheurer, MD, a hospitalist and chief quality officer at the Medical University of South Carolina, Charleston, said that she, too, has not used advance care planning codes. The reimbursement tool is a positive step forward, she said, but so far, it’s not an easy insert into a hospitalist’s practice.

“It’s not top of mind as far as a billing practice,” she said. “It’s not built into the typical work flow. Obviously, it’s not every patient, it’s not everyday, so you have to remember to put it into your work flow. That’s probably the biggest barrier for most hospitalists: either not knowing about it at all or not yet figuring out how to weave it into what they already do.”

Dr. Danielle B. Scheurer
Primary care physicians are likely in a better position to take advantage of the benefit, Dr. Scheurer said. “Ideally, these conversations would be with physicians that patients already have an established relationship with.”
 

 

 

Overcoming hurdles through experience

Using the advance care planning benefit has been easier said than done in his practice, according to Carl R. Olden, MD, a family physician in Yakima, Wash. The logistics of scheduling and patient reluctance are contributing to low usage of the new codes, said Dr. Olden, a member of the American Academy of Family Physicians board of directors.

Between Sept. 1, 2016, and Aug. 31, 2017, the family medicine, primary care, internal medicine, and pulmonary medicine members of Dr. Olden’s network who provide end-of-life counseling submitted billing for a total of 106,160 Medicare visits. Of those visits, the 99497 code was submitted only 32 times, according to data provided by Dr. Olden.

At Dr. Olden’s 16-physician practice, there are no registered nurses to help set up and start Medicare wellness visits, which the advance care planning session benefit is designed to fit within, he said.

“Most of those Medicare wellness visits are driven by having a registered nurse do most of the work,” he said. “[For us] to schedule a wellness visit, it’s mostly physician work and to do a 30-minute wellness visit, most of us can see three patients in that 30-minute slot, so it ends up not being very cost effective.”

Dr. Carl R. Olden
In addition, patients are often hesitant to focus on advance care planning during visits rather than medical conditions and treatment questions.

“Most of my Medicare patients are folks that have four to five chronic medical conditions, and for them to make a 30-minute visit to the office and not talk about any of those conditions but to talk about home safety and advance directives and fall prevention, it’s hard for them to understand that,” he said.

Dr. Newman stresses that while the billing approach takes time to learn, the codes can be weaved into regular practice with some preparation and planning. At her practice, she primarily uses the codes for patients with challenging changes in their health status, sometimes setting up meetings in advance and, other times, conducting a spur-of-the-moment conversation.

“It’s a wonderful benefit,” she said. “I’m not surprised it’s taking awhile to take hold. The reason is you have to prepare for these visits. It takes preparation, including a chart review.”

A common misconception is that the visit must be scheduled separately and cannot be added to another visit, she said. Doctors can bill the advance care planning codes on the same day as an evaluation and management service. For instance, if a patient is accompanied by a family member and seen for routine follow-up, the physician can discuss the medical conditions first and later have a discussion about advance care planning. When billing, the physician can then use an evaluation and management code for the part of the visit related to the patient’s medical conditions and also bill for the advance care planning discussion using the new Medicare codes, Dr. Newman said.

“You’re allowed to use a modifier to attach to it to get paid for both on the same day,” she said. She suggested checking local Medicare policy for the use of the appropriate modifier, usually 26. “One thing that’s important to understand is there’s a lot of short discussions about advanced care planning that doesn’t fit the code. So if a patient wants to have a 5-minute conversation – that happens a lot – these will not be billable or counted under this new benefit. Fifteen minutes is the least amount of time that qualifies for 99497.”

Dr. Sweet said that she expects greater use of the codes as more doctors become aware of how they can be used.

“Once people use it a time or two, they will use it a lot more,” Dr. Sweet said. “It takes time to change, and it takes time to make time to do the things we need to do. But especially, as we move into high-value care, something like this hopefully, [doctors] will embrace.”

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When Donna Sweet, MD, sees patients for routine exams, death and dying are often the furthest thing from their minds. Regardless of age or health status, however, Dr. Sweet regularly asks patients about end-of-life care and whether they’ve considered their options.

In the past, physicians had to be creative in how they coded for such conversations, but Medicare’s newish advance care planning benefit is changing that.

Dr. Donna Sweet
“I’ve found patients to be appreciative of having it brought up when they’re not terribly ill,” says Dr. Sweet, professor of medicine at the University of Kansas, Wichita. “That way, they can go home and discuss with spouses and kids. It’s nice to be reimbursed for something that needs to be done.”

Staring in 2016, the Centers for Medicare & Medicaid Services began reimbursing physicians for advance care planning discussions with the approval of two new codes: 99497 and 99498. The codes pay about $86 for the first 30-minutes of a face-to-face conversation with a patient, family member, and/or surrogate and about $75 for additional sessions. Services can be furnished in both inpatient and ambulatory settings, and payment is not limited to particular physician specialties.

Dr. Sweet said that she uses these codes a couple times a week when patients visit for reasons such as routine hypertension or diabetes exams or annual Medicare wellness visits. To broach the subject, Dr. Sweet said it helps to have literature about advance care planning in the room that patients can review.

“It’s just a matter of bringing it up,” she said. “Considering some of the other codes, the advance care planning code is really pretty simple.”

However, doctors like Dr. Sweet appear to be in the minority when it comes to providing this service. Of the nearly 57 million beneficiaries enrolled in Medicare at the end of 2016, only about 1% received advance care planning sessions, according to analysis of Medicare data posted by Kaiser Health News. Nationwide, health providers submitted about $93 million in charges, of which $43 million was paid by Medicare.

Dr. Mary M. Newman
“It takes awhile to learn how to use new codes,” said Mary M. Newman, MD, an internist based in Lutherville, Md., and the American College of Physician’s adviser to the American Medical Association Relative Scale Value Update Committee. “A lot of people simply do not have the time to learn how to code something they haven’t coded before. They have to look it up, and they have to make sure they are complying with the new guidelines. I can see where this is something that’s going to take awhile to learn how to do.”
 

Challenges deter conversations

During a recent visit with a 72-year-old cancer patient, Bridget Fahy, MD, a surgical oncologist at the University of New Mexico, Albuquerque, spent time discussing advance directives and the importance of naming a surrogate decision maker. Dr. Fahy had treated the patient for two different cancers over the course of 4 years, and he was now diagnosed with a third, she recalled during an interview. Figuring out an advance care plan, though, proved complicated: The man was not married, had no children, and had no family members who lived in the state.

Although Dr. Fahy was aware of the Medicare advance care planning codes, she did not bill the session as such.

“Even in the course of having that conversation, I’m more apt to bill on time than I am specifically to meet the Medicare requirements for the documentation for [the benefit],” she said.

Dr. Bridget Fahy
Time constraints and documentation hurdles act as barriers to using the advance care planing codes, Dr. Fahy said. During a typical new patient visit, for instance, surgeons already have a significant volume of information to discuss regarding evaluation and surgical management of the patient’s condition; often, there is not enough time to discuss advance care planning, she said.

“There are two pieces required to take advantage of the advance care planning benefit code: having the conversation and documenting it,” Dr. Fahy noted. “What I write at the end of a resident note or an advanced practice provider note is going to be more focused on the counseling I had with the patient about their condition, the evaluation, and what the treatment plan is going to be. For surgeons to utilize the advance care planning codes, they have to have knowledge of the code, which many do not; they must know the requirements for documenting the conversation; and they have to have the time needed to have the conversation while also addressing all of the surgery-specific issues that need to be covered during the visit. There are a number of hurdles to overcome.”

Danielle B. Scheurer, MD, a hospitalist and chief quality officer at the Medical University of South Carolina, Charleston, said that she, too, has not used advance care planning codes. The reimbursement tool is a positive step forward, she said, but so far, it’s not an easy insert into a hospitalist’s practice.

“It’s not top of mind as far as a billing practice,” she said. “It’s not built into the typical work flow. Obviously, it’s not every patient, it’s not everyday, so you have to remember to put it into your work flow. That’s probably the biggest barrier for most hospitalists: either not knowing about it at all or not yet figuring out how to weave it into what they already do.”

Dr. Danielle B. Scheurer
Primary care physicians are likely in a better position to take advantage of the benefit, Dr. Scheurer said. “Ideally, these conversations would be with physicians that patients already have an established relationship with.”
 

 

 

Overcoming hurdles through experience

Using the advance care planning benefit has been easier said than done in his practice, according to Carl R. Olden, MD, a family physician in Yakima, Wash. The logistics of scheduling and patient reluctance are contributing to low usage of the new codes, said Dr. Olden, a member of the American Academy of Family Physicians board of directors.

Between Sept. 1, 2016, and Aug. 31, 2017, the family medicine, primary care, internal medicine, and pulmonary medicine members of Dr. Olden’s network who provide end-of-life counseling submitted billing for a total of 106,160 Medicare visits. Of those visits, the 99497 code was submitted only 32 times, according to data provided by Dr. Olden.

At Dr. Olden’s 16-physician practice, there are no registered nurses to help set up and start Medicare wellness visits, which the advance care planning session benefit is designed to fit within, he said.

“Most of those Medicare wellness visits are driven by having a registered nurse do most of the work,” he said. “[For us] to schedule a wellness visit, it’s mostly physician work and to do a 30-minute wellness visit, most of us can see three patients in that 30-minute slot, so it ends up not being very cost effective.”

Dr. Carl R. Olden
In addition, patients are often hesitant to focus on advance care planning during visits rather than medical conditions and treatment questions.

“Most of my Medicare patients are folks that have four to five chronic medical conditions, and for them to make a 30-minute visit to the office and not talk about any of those conditions but to talk about home safety and advance directives and fall prevention, it’s hard for them to understand that,” he said.

Dr. Newman stresses that while the billing approach takes time to learn, the codes can be weaved into regular practice with some preparation and planning. At her practice, she primarily uses the codes for patients with challenging changes in their health status, sometimes setting up meetings in advance and, other times, conducting a spur-of-the-moment conversation.

“It’s a wonderful benefit,” she said. “I’m not surprised it’s taking awhile to take hold. The reason is you have to prepare for these visits. It takes preparation, including a chart review.”

A common misconception is that the visit must be scheduled separately and cannot be added to another visit, she said. Doctors can bill the advance care planning codes on the same day as an evaluation and management service. For instance, if a patient is accompanied by a family member and seen for routine follow-up, the physician can discuss the medical conditions first and later have a discussion about advance care planning. When billing, the physician can then use an evaluation and management code for the part of the visit related to the patient’s medical conditions and also bill for the advance care planning discussion using the new Medicare codes, Dr. Newman said.

“You’re allowed to use a modifier to attach to it to get paid for both on the same day,” she said. She suggested checking local Medicare policy for the use of the appropriate modifier, usually 26. “One thing that’s important to understand is there’s a lot of short discussions about advanced care planning that doesn’t fit the code. So if a patient wants to have a 5-minute conversation – that happens a lot – these will not be billable or counted under this new benefit. Fifteen minutes is the least amount of time that qualifies for 99497.”

Dr. Sweet said that she expects greater use of the codes as more doctors become aware of how they can be used.

“Once people use it a time or two, they will use it a lot more,” Dr. Sweet said. “It takes time to change, and it takes time to make time to do the things we need to do. But especially, as we move into high-value care, something like this hopefully, [doctors] will embrace.”

 

When Donna Sweet, MD, sees patients for routine exams, death and dying are often the furthest thing from their minds. Regardless of age or health status, however, Dr. Sweet regularly asks patients about end-of-life care and whether they’ve considered their options.

In the past, physicians had to be creative in how they coded for such conversations, but Medicare’s newish advance care planning benefit is changing that.

Dr. Donna Sweet
“I’ve found patients to be appreciative of having it brought up when they’re not terribly ill,” says Dr. Sweet, professor of medicine at the University of Kansas, Wichita. “That way, they can go home and discuss with spouses and kids. It’s nice to be reimbursed for something that needs to be done.”

Staring in 2016, the Centers for Medicare & Medicaid Services began reimbursing physicians for advance care planning discussions with the approval of two new codes: 99497 and 99498. The codes pay about $86 for the first 30-minutes of a face-to-face conversation with a patient, family member, and/or surrogate and about $75 for additional sessions. Services can be furnished in both inpatient and ambulatory settings, and payment is not limited to particular physician specialties.

Dr. Sweet said that she uses these codes a couple times a week when patients visit for reasons such as routine hypertension or diabetes exams or annual Medicare wellness visits. To broach the subject, Dr. Sweet said it helps to have literature about advance care planning in the room that patients can review.

“It’s just a matter of bringing it up,” she said. “Considering some of the other codes, the advance care planning code is really pretty simple.”

However, doctors like Dr. Sweet appear to be in the minority when it comes to providing this service. Of the nearly 57 million beneficiaries enrolled in Medicare at the end of 2016, only about 1% received advance care planning sessions, according to analysis of Medicare data posted by Kaiser Health News. Nationwide, health providers submitted about $93 million in charges, of which $43 million was paid by Medicare.

Dr. Mary M. Newman
“It takes awhile to learn how to use new codes,” said Mary M. Newman, MD, an internist based in Lutherville, Md., and the American College of Physician’s adviser to the American Medical Association Relative Scale Value Update Committee. “A lot of people simply do not have the time to learn how to code something they haven’t coded before. They have to look it up, and they have to make sure they are complying with the new guidelines. I can see where this is something that’s going to take awhile to learn how to do.”
 

Challenges deter conversations

During a recent visit with a 72-year-old cancer patient, Bridget Fahy, MD, a surgical oncologist at the University of New Mexico, Albuquerque, spent time discussing advance directives and the importance of naming a surrogate decision maker. Dr. Fahy had treated the patient for two different cancers over the course of 4 years, and he was now diagnosed with a third, she recalled during an interview. Figuring out an advance care plan, though, proved complicated: The man was not married, had no children, and had no family members who lived in the state.

Although Dr. Fahy was aware of the Medicare advance care planning codes, she did not bill the session as such.

“Even in the course of having that conversation, I’m more apt to bill on time than I am specifically to meet the Medicare requirements for the documentation for [the benefit],” she said.

Dr. Bridget Fahy
Time constraints and documentation hurdles act as barriers to using the advance care planing codes, Dr. Fahy said. During a typical new patient visit, for instance, surgeons already have a significant volume of information to discuss regarding evaluation and surgical management of the patient’s condition; often, there is not enough time to discuss advance care planning, she said.

“There are two pieces required to take advantage of the advance care planning benefit code: having the conversation and documenting it,” Dr. Fahy noted. “What I write at the end of a resident note or an advanced practice provider note is going to be more focused on the counseling I had with the patient about their condition, the evaluation, and what the treatment plan is going to be. For surgeons to utilize the advance care planning codes, they have to have knowledge of the code, which many do not; they must know the requirements for documenting the conversation; and they have to have the time needed to have the conversation while also addressing all of the surgery-specific issues that need to be covered during the visit. There are a number of hurdles to overcome.”

Danielle B. Scheurer, MD, a hospitalist and chief quality officer at the Medical University of South Carolina, Charleston, said that she, too, has not used advance care planning codes. The reimbursement tool is a positive step forward, she said, but so far, it’s not an easy insert into a hospitalist’s practice.

“It’s not top of mind as far as a billing practice,” she said. “It’s not built into the typical work flow. Obviously, it’s not every patient, it’s not everyday, so you have to remember to put it into your work flow. That’s probably the biggest barrier for most hospitalists: either not knowing about it at all or not yet figuring out how to weave it into what they already do.”

Dr. Danielle B. Scheurer
Primary care physicians are likely in a better position to take advantage of the benefit, Dr. Scheurer said. “Ideally, these conversations would be with physicians that patients already have an established relationship with.”
 

 

 

Overcoming hurdles through experience

Using the advance care planning benefit has been easier said than done in his practice, according to Carl R. Olden, MD, a family physician in Yakima, Wash. The logistics of scheduling and patient reluctance are contributing to low usage of the new codes, said Dr. Olden, a member of the American Academy of Family Physicians board of directors.

Between Sept. 1, 2016, and Aug. 31, 2017, the family medicine, primary care, internal medicine, and pulmonary medicine members of Dr. Olden’s network who provide end-of-life counseling submitted billing for a total of 106,160 Medicare visits. Of those visits, the 99497 code was submitted only 32 times, according to data provided by Dr. Olden.

At Dr. Olden’s 16-physician practice, there are no registered nurses to help set up and start Medicare wellness visits, which the advance care planning session benefit is designed to fit within, he said.

“Most of those Medicare wellness visits are driven by having a registered nurse do most of the work,” he said. “[For us] to schedule a wellness visit, it’s mostly physician work and to do a 30-minute wellness visit, most of us can see three patients in that 30-minute slot, so it ends up not being very cost effective.”

Dr. Carl R. Olden
In addition, patients are often hesitant to focus on advance care planning during visits rather than medical conditions and treatment questions.

“Most of my Medicare patients are folks that have four to five chronic medical conditions, and for them to make a 30-minute visit to the office and not talk about any of those conditions but to talk about home safety and advance directives and fall prevention, it’s hard for them to understand that,” he said.

Dr. Newman stresses that while the billing approach takes time to learn, the codes can be weaved into regular practice with some preparation and planning. At her practice, she primarily uses the codes for patients with challenging changes in their health status, sometimes setting up meetings in advance and, other times, conducting a spur-of-the-moment conversation.

“It’s a wonderful benefit,” she said. “I’m not surprised it’s taking awhile to take hold. The reason is you have to prepare for these visits. It takes preparation, including a chart review.”

A common misconception is that the visit must be scheduled separately and cannot be added to another visit, she said. Doctors can bill the advance care planning codes on the same day as an evaluation and management service. For instance, if a patient is accompanied by a family member and seen for routine follow-up, the physician can discuss the medical conditions first and later have a discussion about advance care planning. When billing, the physician can then use an evaluation and management code for the part of the visit related to the patient’s medical conditions and also bill for the advance care planning discussion using the new Medicare codes, Dr. Newman said.

“You’re allowed to use a modifier to attach to it to get paid for both on the same day,” she said. She suggested checking local Medicare policy for the use of the appropriate modifier, usually 26. “One thing that’s important to understand is there’s a lot of short discussions about advanced care planning that doesn’t fit the code. So if a patient wants to have a 5-minute conversation – that happens a lot – these will not be billable or counted under this new benefit. Fifteen minutes is the least amount of time that qualifies for 99497.”

Dr. Sweet said that she expects greater use of the codes as more doctors become aware of how they can be used.

“Once people use it a time or two, they will use it a lot more,” Dr. Sweet said. “It takes time to change, and it takes time to make time to do the things we need to do. But especially, as we move into high-value care, something like this hopefully, [doctors] will embrace.”

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Ixekizumab has profound impact on genital psoriasis

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– The interleukin-17A inhibitor ixekizumab provided rapid clearance of genital psoriasis in a phase 3b clinical trial, with significant improvement seen as early as week 1, Caitriona Ryan, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.

The highly targeted monoclonal antibody also improved the intense itching that’s a particularly prominent feature of genital psoriasis.

Bruce Jancin/Frontline Medical News
Dr. Caitriona Ryan
“Most importantly, in my view, ixekizumab minimized how often genital psoriasis limited the frequency of sexual activity. This is a disease that can have a very significant impact on quality of life and sexual health,” observed Dr. Ryan of St. Vincent’s Hospital, Dublin.

“Genital psoriasis is a hidden part of psoriasis. Unfortunately, as dermatologists we do a bad job of evaluating our patients for it. They are ashamed and embarrassed to bring up the topic with their dermatologists. Hopefully, this study will create some awareness around the topic,” she said.

This was the first-ever randomized trial to evaluate the effect of a biologic agent specifically on genital psoriasis. It was also the first study of a biologic in psoriasis patients with less than 10% body surface area involved.

“That’s a very important thing,” according to the dermatologist. “There are lots of patients with genital psoriasis who have less than 10% body surface area involved and therefore don’t qualify for biologic therapy, even though their genital psoriasis can be incredibly debilitating.”

The 12-week, multicenter, double-blind trial included 149 patients with a baseline static Physician’s Global Assessment of Genitalia (sPGA-G) score of at least 3 on a 0-5 scale. All participants had failed to respond to at least one topical therapy for their genital psoriasis, such as a corticosteroid, a calcineurin inhibitor, or a vitamin D analog. The subjects averaged a 16-year history of psoriasis and a 9-year history of genital psoriasis. Thirty-eight percent of participants had an involved body surface area of at least 1% but less than 10%.

Patients were randomized to ixekizumab (Taltz) given in the usual way – a subcutaneous loading dose of 160 mg, followed by repeat 80-mg injections every 2 weeks – or placebo.

The primary study endpoint was achievement of an sPGA-G score of 0 or 1, meaning clear or almost clear, as assessed by blinded investigators. At the 12-week mark, the rate was 73% in the ixekizumab group and 8% in controls. The sPGA-G score already differed significantly between the two study arms at the first assessment, after 1 week. The treatment success rate was closely similar in patients with or without at least 10% total body surface area involved.

A key secondary endpoint concerned sexual health. Among patients who at baseline indicated that in the past week, their genital psoriasis “sometimes,” “often,” or “always” limited the frequency of their sexual activity, at week 12, 78% of those in the ixekizumab group answered the same question on the Sexual Frequency Questionnaire “never” or “rarely,” compared with 21% of controls.

“This is huge. It’s such an important part of our patients’ lives, and there was a big difference by week 1,” Dr. Ryan noted.

On another secondary endpoint, 60% of the ixekizumab group reported at least a 3-point improvement in the 0-10 Genital Itch Numeric Rating Scale at week 12, compared with 8% of controls, with a statistically significant difference apparent at week 2.

“Itch is the most frequently reported symptom in our patients with genital psoriasis, and it seems to be much more impactful than itch from psoriasis elsewhere,” Dr. Ryan commented.

The side effect profile of ixekizumab was the same as has been seen in larger, longer-term studies. There were no serious ixekizumab-related adverse events, and no cases of candidiasis.

The study was sponsored by Eli Lilly. Dr. Ryan reported serving as an advisory board member to and/or receiving honoraria from that company and more than half a dozen other pharmaceutical companies.
 

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– The interleukin-17A inhibitor ixekizumab provided rapid clearance of genital psoriasis in a phase 3b clinical trial, with significant improvement seen as early as week 1, Caitriona Ryan, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.

The highly targeted monoclonal antibody also improved the intense itching that’s a particularly prominent feature of genital psoriasis.

Bruce Jancin/Frontline Medical News
Dr. Caitriona Ryan
“Most importantly, in my view, ixekizumab minimized how often genital psoriasis limited the frequency of sexual activity. This is a disease that can have a very significant impact on quality of life and sexual health,” observed Dr. Ryan of St. Vincent’s Hospital, Dublin.

“Genital psoriasis is a hidden part of psoriasis. Unfortunately, as dermatologists we do a bad job of evaluating our patients for it. They are ashamed and embarrassed to bring up the topic with their dermatologists. Hopefully, this study will create some awareness around the topic,” she said.

This was the first-ever randomized trial to evaluate the effect of a biologic agent specifically on genital psoriasis. It was also the first study of a biologic in psoriasis patients with less than 10% body surface area involved.

“That’s a very important thing,” according to the dermatologist. “There are lots of patients with genital psoriasis who have less than 10% body surface area involved and therefore don’t qualify for biologic therapy, even though their genital psoriasis can be incredibly debilitating.”

The 12-week, multicenter, double-blind trial included 149 patients with a baseline static Physician’s Global Assessment of Genitalia (sPGA-G) score of at least 3 on a 0-5 scale. All participants had failed to respond to at least one topical therapy for their genital psoriasis, such as a corticosteroid, a calcineurin inhibitor, or a vitamin D analog. The subjects averaged a 16-year history of psoriasis and a 9-year history of genital psoriasis. Thirty-eight percent of participants had an involved body surface area of at least 1% but less than 10%.

Patients were randomized to ixekizumab (Taltz) given in the usual way – a subcutaneous loading dose of 160 mg, followed by repeat 80-mg injections every 2 weeks – or placebo.

The primary study endpoint was achievement of an sPGA-G score of 0 or 1, meaning clear or almost clear, as assessed by blinded investigators. At the 12-week mark, the rate was 73% in the ixekizumab group and 8% in controls. The sPGA-G score already differed significantly between the two study arms at the first assessment, after 1 week. The treatment success rate was closely similar in patients with or without at least 10% total body surface area involved.

A key secondary endpoint concerned sexual health. Among patients who at baseline indicated that in the past week, their genital psoriasis “sometimes,” “often,” or “always” limited the frequency of their sexual activity, at week 12, 78% of those in the ixekizumab group answered the same question on the Sexual Frequency Questionnaire “never” or “rarely,” compared with 21% of controls.

“This is huge. It’s such an important part of our patients’ lives, and there was a big difference by week 1,” Dr. Ryan noted.

On another secondary endpoint, 60% of the ixekizumab group reported at least a 3-point improvement in the 0-10 Genital Itch Numeric Rating Scale at week 12, compared with 8% of controls, with a statistically significant difference apparent at week 2.

“Itch is the most frequently reported symptom in our patients with genital psoriasis, and it seems to be much more impactful than itch from psoriasis elsewhere,” Dr. Ryan commented.

The side effect profile of ixekizumab was the same as has been seen in larger, longer-term studies. There were no serious ixekizumab-related adverse events, and no cases of candidiasis.

The study was sponsored by Eli Lilly. Dr. Ryan reported serving as an advisory board member to and/or receiving honoraria from that company and more than half a dozen other pharmaceutical companies.
 

 

– The interleukin-17A inhibitor ixekizumab provided rapid clearance of genital psoriasis in a phase 3b clinical trial, with significant improvement seen as early as week 1, Caitriona Ryan, MD, reported at the annual congress of the European Academy of Dermatology and Venereology.

The highly targeted monoclonal antibody also improved the intense itching that’s a particularly prominent feature of genital psoriasis.

Bruce Jancin/Frontline Medical News
Dr. Caitriona Ryan
“Most importantly, in my view, ixekizumab minimized how often genital psoriasis limited the frequency of sexual activity. This is a disease that can have a very significant impact on quality of life and sexual health,” observed Dr. Ryan of St. Vincent’s Hospital, Dublin.

“Genital psoriasis is a hidden part of psoriasis. Unfortunately, as dermatologists we do a bad job of evaluating our patients for it. They are ashamed and embarrassed to bring up the topic with their dermatologists. Hopefully, this study will create some awareness around the topic,” she said.

This was the first-ever randomized trial to evaluate the effect of a biologic agent specifically on genital psoriasis. It was also the first study of a biologic in psoriasis patients with less than 10% body surface area involved.

“That’s a very important thing,” according to the dermatologist. “There are lots of patients with genital psoriasis who have less than 10% body surface area involved and therefore don’t qualify for biologic therapy, even though their genital psoriasis can be incredibly debilitating.”

The 12-week, multicenter, double-blind trial included 149 patients with a baseline static Physician’s Global Assessment of Genitalia (sPGA-G) score of at least 3 on a 0-5 scale. All participants had failed to respond to at least one topical therapy for their genital psoriasis, such as a corticosteroid, a calcineurin inhibitor, or a vitamin D analog. The subjects averaged a 16-year history of psoriasis and a 9-year history of genital psoriasis. Thirty-eight percent of participants had an involved body surface area of at least 1% but less than 10%.

Patients were randomized to ixekizumab (Taltz) given in the usual way – a subcutaneous loading dose of 160 mg, followed by repeat 80-mg injections every 2 weeks – or placebo.

The primary study endpoint was achievement of an sPGA-G score of 0 or 1, meaning clear or almost clear, as assessed by blinded investigators. At the 12-week mark, the rate was 73% in the ixekizumab group and 8% in controls. The sPGA-G score already differed significantly between the two study arms at the first assessment, after 1 week. The treatment success rate was closely similar in patients with or without at least 10% total body surface area involved.

A key secondary endpoint concerned sexual health. Among patients who at baseline indicated that in the past week, their genital psoriasis “sometimes,” “often,” or “always” limited the frequency of their sexual activity, at week 12, 78% of those in the ixekizumab group answered the same question on the Sexual Frequency Questionnaire “never” or “rarely,” compared with 21% of controls.

“This is huge. It’s such an important part of our patients’ lives, and there was a big difference by week 1,” Dr. Ryan noted.

On another secondary endpoint, 60% of the ixekizumab group reported at least a 3-point improvement in the 0-10 Genital Itch Numeric Rating Scale at week 12, compared with 8% of controls, with a statistically significant difference apparent at week 2.

“Itch is the most frequently reported symptom in our patients with genital psoriasis, and it seems to be much more impactful than itch from psoriasis elsewhere,” Dr. Ryan commented.

The side effect profile of ixekizumab was the same as has been seen in larger, longer-term studies. There were no serious ixekizumab-related adverse events, and no cases of candidiasis.

The study was sponsored by Eli Lilly. Dr. Ryan reported serving as an advisory board member to and/or receiving honoraria from that company and more than half a dozen other pharmaceutical companies.
 

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Vitals

 

Key clinical point: First-ever trial of a biologic agent in genital psoriasis shows heartening results.

Major finding: 73% of patients with moderate to severe genital psoriasis were clear or almost clear of their genital disease after 12 weeks of ixekizumab, vs. 8% of controls.

Data source: This was a randomized, double-blind, placebo-controlled, multicenter, 12-week clinical trial in 149 patients with moderate to severe genital psoriasis.

Disclosures: The study was sponsored by Eli Lilly. The presenter reported serving as an advisory board member to and/or receiving honoraria from that company and more than half a dozen other pharmaceutical companies.

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Connect with the CHEST Foundation at CHEST 2017

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Tue, 10/23/2018 - 16:10

 

Be sure to check out our ever-growing presence at CHEST 2017, showcasing the numerous ways we support CHEST members, patients, and the community. Have time for a break or interested in networking with leaders in CHEST medicine? Stop by one of our many open invitation activities listed below to learn more about how the CHEST Foundation can support you in your efforts to champion lung health through clinical research grants, community service, and patient education.
 

SATURDAY OCTOBER 28

2:00 PM – 4:00 PM (Open Invitation)

Lung Health Experience—Community COPD Screening

Nathan Phillips Square
100 Queen St W, Toronto, ON M5H 2N2, Canada
 

SUNDAY OCTOBER 29

9:00 AM - 5:00 PM
Donor Lounge
Convention Center, 803B



3:15 PM - 4:15 PM
Foundation Session: Severe Asthma Care at Its Best: Shared Decision Making
Convention Center, 716A



4:30 PM - 5:30 PM
Foundation Session: No Money, No Mission: Tips for Getting Your Grant Funded
Convention Center, 716B
 

MONDAY OCTOBER 30

9:00 AM - 5:00 PM

Donor Lounge
Convention Center, 803B



8:45 AM – 10:00 AM
Opening Session/CHEST Foundation
Awards Convocation
Convention Center, Hall G, Level 800



6:30 PM - 8:00 PM
Boehringer Ingelheim and CHEST Foundation Patient Engagement Summit
Sheraton, Grand Ballroom Centre



8:00 PM – 10:00 PM
Young Professionals Reception
(RSVP chestfoundation.org/youngprofessionals)

The Fifth Social Club
225 Richmond St W Suite 100
Toronto, ON M5V 1W2, Canada
 

TUESDAY OCTOBER 31

9:00 AM - 5:00 PM
Donor Lounge
Convention Center, 803B
 

WEDNESDAY NOVEMBER 1

9:00 AM - 12:00 PM
Donor Lounge
Convention Center, 803B
 

ADD YOUR VOICE

and champion lung health at the Actelion Booth #1322. For every addition to the graffiti wall, Actelion will donate $25 to the CHEST Foundation.
 

Thank you for your support of the CHEST Foundation and our mission of championing lung health!

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Be sure to check out our ever-growing presence at CHEST 2017, showcasing the numerous ways we support CHEST members, patients, and the community. Have time for a break or interested in networking with leaders in CHEST medicine? Stop by one of our many open invitation activities listed below to learn more about how the CHEST Foundation can support you in your efforts to champion lung health through clinical research grants, community service, and patient education.
 

SATURDAY OCTOBER 28

2:00 PM – 4:00 PM (Open Invitation)

Lung Health Experience—Community COPD Screening

Nathan Phillips Square
100 Queen St W, Toronto, ON M5H 2N2, Canada
 

SUNDAY OCTOBER 29

9:00 AM - 5:00 PM
Donor Lounge
Convention Center, 803B



3:15 PM - 4:15 PM
Foundation Session: Severe Asthma Care at Its Best: Shared Decision Making
Convention Center, 716A



4:30 PM - 5:30 PM
Foundation Session: No Money, No Mission: Tips for Getting Your Grant Funded
Convention Center, 716B
 

MONDAY OCTOBER 30

9:00 AM - 5:00 PM

Donor Lounge
Convention Center, 803B



8:45 AM – 10:00 AM
Opening Session/CHEST Foundation
Awards Convocation
Convention Center, Hall G, Level 800



6:30 PM - 8:00 PM
Boehringer Ingelheim and CHEST Foundation Patient Engagement Summit
Sheraton, Grand Ballroom Centre



8:00 PM – 10:00 PM
Young Professionals Reception
(RSVP chestfoundation.org/youngprofessionals)

The Fifth Social Club
225 Richmond St W Suite 100
Toronto, ON M5V 1W2, Canada
 

TUESDAY OCTOBER 31

9:00 AM - 5:00 PM
Donor Lounge
Convention Center, 803B
 

WEDNESDAY NOVEMBER 1

9:00 AM - 12:00 PM
Donor Lounge
Convention Center, 803B
 

ADD YOUR VOICE

and champion lung health at the Actelion Booth #1322. For every addition to the graffiti wall, Actelion will donate $25 to the CHEST Foundation.
 

Thank you for your support of the CHEST Foundation and our mission of championing lung health!

 

Be sure to check out our ever-growing presence at CHEST 2017, showcasing the numerous ways we support CHEST members, patients, and the community. Have time for a break or interested in networking with leaders in CHEST medicine? Stop by one of our many open invitation activities listed below to learn more about how the CHEST Foundation can support you in your efforts to champion lung health through clinical research grants, community service, and patient education.
 

SATURDAY OCTOBER 28

2:00 PM – 4:00 PM (Open Invitation)

Lung Health Experience—Community COPD Screening

Nathan Phillips Square
100 Queen St W, Toronto, ON M5H 2N2, Canada
 

SUNDAY OCTOBER 29

9:00 AM - 5:00 PM
Donor Lounge
Convention Center, 803B



3:15 PM - 4:15 PM
Foundation Session: Severe Asthma Care at Its Best: Shared Decision Making
Convention Center, 716A



4:30 PM - 5:30 PM
Foundation Session: No Money, No Mission: Tips for Getting Your Grant Funded
Convention Center, 716B
 

MONDAY OCTOBER 30

9:00 AM - 5:00 PM

Donor Lounge
Convention Center, 803B



8:45 AM – 10:00 AM
Opening Session/CHEST Foundation
Awards Convocation
Convention Center, Hall G, Level 800



6:30 PM - 8:00 PM
Boehringer Ingelheim and CHEST Foundation Patient Engagement Summit
Sheraton, Grand Ballroom Centre



8:00 PM – 10:00 PM
Young Professionals Reception
(RSVP chestfoundation.org/youngprofessionals)

The Fifth Social Club
225 Richmond St W Suite 100
Toronto, ON M5V 1W2, Canada
 

TUESDAY OCTOBER 31

9:00 AM - 5:00 PM
Donor Lounge
Convention Center, 803B
 

WEDNESDAY NOVEMBER 1

9:00 AM - 12:00 PM
Donor Lounge
Convention Center, 803B
 

ADD YOUR VOICE

and champion lung health at the Actelion Booth #1322. For every addition to the graffiti wall, Actelion will donate $25 to the CHEST Foundation.
 

Thank you for your support of the CHEST Foundation and our mission of championing lung health!

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Trump order allows end-around ACA rules

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Changed
Wed, 04/03/2019 - 10:25


An executive order signed by President Donald J. Trump aims to expand health care coverage options, primarily for small businesses.

The order includes three key provisions.

First, it allows small businesses to band together to buy insurance collectively for their workers and allows plans to be sold across state lines, in theory extending the buying power that comes with a larger base of employees to smaller businesses.

Gage Skidmore/Wikimedia Commons/CC BY-SA 2.0
President Trump
“This will create tremendous competition,” President Trump said Oct. 12. “The competition will be staggering. Insurance will be fighting to get every single person signed up. ... This will allow thousands of small business employers to have the same purchasing power as large employers to get more affordable and generous insurance for their workers.”

Employers participating in association health plans “cannot exclude any employee from joining the plan and cannot develop premiums based on health condition,” according to a White House statement on the executive order.

Second, the executive order allows broader use of limited duration health insurance – short-term policies that are not intended to be comprehensive offerings and are not subject to Affordable Care Act coverage requirements.

These plans “typically feature broad provider networks and high coverage limits,” according to the White House statement. The plans are geared toward “people between jobs, people in counties with only a single insurer offering exchange plans, people with limited coverage networks, and people who missed the open enrollment period but still want insurance,” according to the executive order.

Association health plans and the short-term, limited duration insurance will not need to fully cover the ACA’s essential health benefits package; instead, they are intended to be alternatives to “expensive, mandate-laden [ACA] insurance,” according to the executive order.

Third, the order directs the secretaries of Health & Human Services, Treasury, and Labor to “explore how they can allow more businesses to use tax-free health reimbursement arrangements, or HRAs, to compensate their employees for their health care expenses,” according to the White House statement.

HRAs allow employers to cover select items, such as copayments, deductibles, and other items, that are not covered by the insurance plan offered to employees.

“With these actions, we are moving toward lower costs and more options in the health care market and taking crucial steps toward saving the American people from the nightmare of Obamacare,” President Trump said, adding that the White House will continue to put pressure on Congress to finish repeal and replace activities. He also said that Congress will be pursuing block grants, presumably for Medicaid, which he said he had the votes to accomplish.

The action taken today by the White House is already receiving pushback.

The American College of Physicians “has said repeatedly that any attempts by Congress to ‘repeal and replace’ the ACA must first do no harm to patients,” Susan Thompson Hingle, MD, chair of the American College of Physicians Board of Regents, said in a statement. “This executive order utterly fails that test.”

Under the association health plans “small employers would be allowed to purchase health plans that do not meet the ACA’s requirement to provide essential health benefits,” Dr. Hingle noted. “This means that plans would no longer have to cover medical patients needs; plans could choose not to cover pregnancy, maternity, and newborn care, or even chemotherapy. This would also mean that the ACA’s prohibition on annual and lifetime limits on coverage would no longer apply to any service an employer decides is not essential. These changes would be devastating for patients who need access to the ‘nonessential’ services, leaving them with potentially millions of dollars in out-of-pocket costs despite being insured.”

Association health plans also could further destabilize the individual market if healthy workers – who currently may have purchased coverage on the individual market – shifted to less comprehensive association health plans, leaving even fewer healthy individuals in the individual market. “Insurers will be forced to either leave the markets in droves or charge much higher premiums.”

The rules may not be able to provide the relief that President Trump has promised, according to Julius Hobson, a Washington-based health care lobbyist

“The changes that he is talking about are going to require departments and agencies to promulgate rules. They just simply can’t do that by fiat,” Mr. Hobson said in an interview. “I am not sure that we will see an immediate impact on the executive order. ... When you get down to the nitty-gritty of implementation, we could be a bit away from seeing anything that actually has impact.”

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An executive order signed by President Donald J. Trump aims to expand health care coverage options, primarily for small businesses.

The order includes three key provisions.

First, it allows small businesses to band together to buy insurance collectively for their workers and allows plans to be sold across state lines, in theory extending the buying power that comes with a larger base of employees to smaller businesses.

Gage Skidmore/Wikimedia Commons/CC BY-SA 2.0
President Trump
“This will create tremendous competition,” President Trump said Oct. 12. “The competition will be staggering. Insurance will be fighting to get every single person signed up. ... This will allow thousands of small business employers to have the same purchasing power as large employers to get more affordable and generous insurance for their workers.”

Employers participating in association health plans “cannot exclude any employee from joining the plan and cannot develop premiums based on health condition,” according to a White House statement on the executive order.

Second, the executive order allows broader use of limited duration health insurance – short-term policies that are not intended to be comprehensive offerings and are not subject to Affordable Care Act coverage requirements.

These plans “typically feature broad provider networks and high coverage limits,” according to the White House statement. The plans are geared toward “people between jobs, people in counties with only a single insurer offering exchange plans, people with limited coverage networks, and people who missed the open enrollment period but still want insurance,” according to the executive order.

Association health plans and the short-term, limited duration insurance will not need to fully cover the ACA’s essential health benefits package; instead, they are intended to be alternatives to “expensive, mandate-laden [ACA] insurance,” according to the executive order.

Third, the order directs the secretaries of Health & Human Services, Treasury, and Labor to “explore how they can allow more businesses to use tax-free health reimbursement arrangements, or HRAs, to compensate their employees for their health care expenses,” according to the White House statement.

HRAs allow employers to cover select items, such as copayments, deductibles, and other items, that are not covered by the insurance plan offered to employees.

“With these actions, we are moving toward lower costs and more options in the health care market and taking crucial steps toward saving the American people from the nightmare of Obamacare,” President Trump said, adding that the White House will continue to put pressure on Congress to finish repeal and replace activities. He also said that Congress will be pursuing block grants, presumably for Medicaid, which he said he had the votes to accomplish.

The action taken today by the White House is already receiving pushback.

The American College of Physicians “has said repeatedly that any attempts by Congress to ‘repeal and replace’ the ACA must first do no harm to patients,” Susan Thompson Hingle, MD, chair of the American College of Physicians Board of Regents, said in a statement. “This executive order utterly fails that test.”

Under the association health plans “small employers would be allowed to purchase health plans that do not meet the ACA’s requirement to provide essential health benefits,” Dr. Hingle noted. “This means that plans would no longer have to cover medical patients needs; plans could choose not to cover pregnancy, maternity, and newborn care, or even chemotherapy. This would also mean that the ACA’s prohibition on annual and lifetime limits on coverage would no longer apply to any service an employer decides is not essential. These changes would be devastating for patients who need access to the ‘nonessential’ services, leaving them with potentially millions of dollars in out-of-pocket costs despite being insured.”

Association health plans also could further destabilize the individual market if healthy workers – who currently may have purchased coverage on the individual market – shifted to less comprehensive association health plans, leaving even fewer healthy individuals in the individual market. “Insurers will be forced to either leave the markets in droves or charge much higher premiums.”

The rules may not be able to provide the relief that President Trump has promised, according to Julius Hobson, a Washington-based health care lobbyist

“The changes that he is talking about are going to require departments and agencies to promulgate rules. They just simply can’t do that by fiat,” Mr. Hobson said in an interview. “I am not sure that we will see an immediate impact on the executive order. ... When you get down to the nitty-gritty of implementation, we could be a bit away from seeing anything that actually has impact.”


An executive order signed by President Donald J. Trump aims to expand health care coverage options, primarily for small businesses.

The order includes three key provisions.

First, it allows small businesses to band together to buy insurance collectively for their workers and allows plans to be sold across state lines, in theory extending the buying power that comes with a larger base of employees to smaller businesses.

Gage Skidmore/Wikimedia Commons/CC BY-SA 2.0
President Trump
“This will create tremendous competition,” President Trump said Oct. 12. “The competition will be staggering. Insurance will be fighting to get every single person signed up. ... This will allow thousands of small business employers to have the same purchasing power as large employers to get more affordable and generous insurance for their workers.”

Employers participating in association health plans “cannot exclude any employee from joining the plan and cannot develop premiums based on health condition,” according to a White House statement on the executive order.

Second, the executive order allows broader use of limited duration health insurance – short-term policies that are not intended to be comprehensive offerings and are not subject to Affordable Care Act coverage requirements.

These plans “typically feature broad provider networks and high coverage limits,” according to the White House statement. The plans are geared toward “people between jobs, people in counties with only a single insurer offering exchange plans, people with limited coverage networks, and people who missed the open enrollment period but still want insurance,” according to the executive order.

Association health plans and the short-term, limited duration insurance will not need to fully cover the ACA’s essential health benefits package; instead, they are intended to be alternatives to “expensive, mandate-laden [ACA] insurance,” according to the executive order.

Third, the order directs the secretaries of Health & Human Services, Treasury, and Labor to “explore how they can allow more businesses to use tax-free health reimbursement arrangements, or HRAs, to compensate their employees for their health care expenses,” according to the White House statement.

HRAs allow employers to cover select items, such as copayments, deductibles, and other items, that are not covered by the insurance plan offered to employees.

“With these actions, we are moving toward lower costs and more options in the health care market and taking crucial steps toward saving the American people from the nightmare of Obamacare,” President Trump said, adding that the White House will continue to put pressure on Congress to finish repeal and replace activities. He also said that Congress will be pursuing block grants, presumably for Medicaid, which he said he had the votes to accomplish.

The action taken today by the White House is already receiving pushback.

The American College of Physicians “has said repeatedly that any attempts by Congress to ‘repeal and replace’ the ACA must first do no harm to patients,” Susan Thompson Hingle, MD, chair of the American College of Physicians Board of Regents, said in a statement. “This executive order utterly fails that test.”

Under the association health plans “small employers would be allowed to purchase health plans that do not meet the ACA’s requirement to provide essential health benefits,” Dr. Hingle noted. “This means that plans would no longer have to cover medical patients needs; plans could choose not to cover pregnancy, maternity, and newborn care, or even chemotherapy. This would also mean that the ACA’s prohibition on annual and lifetime limits on coverage would no longer apply to any service an employer decides is not essential. These changes would be devastating for patients who need access to the ‘nonessential’ services, leaving them with potentially millions of dollars in out-of-pocket costs despite being insured.”

Association health plans also could further destabilize the individual market if healthy workers – who currently may have purchased coverage on the individual market – shifted to less comprehensive association health plans, leaving even fewer healthy individuals in the individual market. “Insurers will be forced to either leave the markets in droves or charge much higher premiums.”

The rules may not be able to provide the relief that President Trump has promised, according to Julius Hobson, a Washington-based health care lobbyist

“The changes that he is talking about are going to require departments and agencies to promulgate rules. They just simply can’t do that by fiat,” Mr. Hobson said in an interview. “I am not sure that we will see an immediate impact on the executive order. ... When you get down to the nitty-gritty of implementation, we could be a bit away from seeing anything that actually has impact.”

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The cost of conflation: Avoiding loose talk about the duty to warn

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Thu, 03/28/2019 - 14:46

 

The campaign, election, and administration of President Donald Trump have reinvigorated debate over rule 7.3 of the American Psychiatric Association (APA) code of ethics. Known as the Goldwater Rule for its historical roots in a magazine profile and subsequent libel suit by the 1964 Republican presidential nominee,1 this standard deems it unethical for a psychiatrist to offer a professional opinion of a public figure without conducting an examination and obtaining authorization.2 The American Psychological Association similarly provides that assessments must be based on adequate examination of the individual.3

Growing controversy

Shortly after President Trump’s inauguration, a group of 35 mental health professionals penned a letter in the New York Times stating that he was “incapable of serving safely as president.” Importantly, the writers couched their conclusions in professional expertise and specifically criticized the Goldwater Rule as having subjected their colleagues to self-imposed silence.4 A prominent psychiatrist, Allen J. Frances, MD, responded the following day to caution against “psychiatric name-calling” as a substitute for political action.5

Since then, psychiatrists classifying the APA ethics position as a “gag rule” preventing them from performing a public service have garnered considerable press coverage. When the American Psychoanalytic Association (APsaA) reiterated this summer that only APA members are bound by the Goldwater Rule, Boston Globe Media’s STAT news outlet misreported it as a license for psychiatrists to disregard the standard. Amid the ensuing media storm, the APsaA was forced to clarify that it was not countenancing defiance of psychiatry’s flagship organization and that its own longstanding policy remained unchanged.

Among those chafing against the Goldwater Rule in the current political environment, a call to arms has been the profession’s supposed “duty to warn” the public of the president’s mental health. This rationale was made explicit in an eponymous online movement and town hall forum hosted by Bandy X. Lee, MD, MDiv, a member of Yale University’s psychiatry faculty. According to these critics, an inherent tension exists between the Goldwater Rule’s prohibition on volunteering professional opinions from afar and the imperative to warn about the dangers posed by a leader with mental illness.
 

The duty to warn

Clinicians’ obligation to warn third parties when patients make credible threats or pose a high risk of harm emanates from various state laws, court decisions, and professional ethics rules. In the seminal Tarasoff case, a patient divulged in the course of psychotherapy his plan to murder a fellow student who had rejected his romantic overtures; campus police were alerted, but the intended victim was not. After the plan came to fruition, the California Supreme Court held that therapists must exercise reasonable care to protect “foreseeable victims” where they know or should know that a patient poses a serious danger.6

Although a controversial and massive expansion of tort liability 40 years ago, the basic tenets of Tarasoff have since been adopted by numerous courts, state legislatures, and professional organizations. The American Medical Association (AMA) recognizes an exception to confidentiality to mitigate serious threats of harm to the patient or other identifiable individuals.7 To enable health care professionals to operate in a way that is consistent with these standards, the HIPAA Privacy Rule expressly permits doctors to disclose protected health information, including psychotherapy notes, if the disclosure “is necessary to prevent or lessen a serious and imminent threat to the health or safety of a person or the public.”8

In terms of both professional ethics and privacy law, the duty to warn is framed as a limited and enumerated exception to the general rule that patient communications must be kept in confidence. In the absence of a clinician’s being privy to personal details about a patient via interview and examination, the duty to warn loses all coherence. It is precisely the intimacy of the doctor-patient relationship that gives rise to the fiduciary duty of confidentiality, which in turn must yield to public safety in rare situations where a credible threat is issued against an identifiable victim.
 

Origins of a misconception

Unlike the duty to warn, the Goldwater Rule is neither premised on nor a departure from the dictates of confidentiality. The rule is codified under the section of the APA ethics standards dealing with community and public health activities, not patient privacy. In nearly all cases where the Goldwater Rule could be invoked, the fundamental issue is that no examination has occurred. If it had, informed consent would be required for treatment, and appropriate authorization would be required for disclosure. Moreover, talking with the media – as opposed to alerting law enforcement, family members, or the subject of a threat – would almost never qualify as an appropriate outlet for discharging a physician’s duty to warn.

 

 

Whatever its merits, the Goldwater Rule is intended to distinguish between educational activities – in which psychiatrists share their expertise with the public and shed light on mental illness – and professional opinion wherein psychiatrists offer diagnoses or prognoses unsolicited by the individual.9

Lt. Col. Charles G. Kels
Today’s critics often point to psychological profiling commissioned by government agencies as a reason for the Goldwater Rule’s obsolescence. During the first Gulf War, Jerrold M. Post, MD, a pioneer in this field, compiled a detailed profile and offered Senate testimony on Iraqi dictator Saddam Hussein’s “malignant narcissism.” Dr. Post cited a Tarasoff-inspired justification for his actions, maintaining that his psychiatric expertise could save lives.10

The APA has since clarified that the Goldwater Rule does not prohibit “psychologically informed leadership studies” so long as they maintain scholarly standards and do not specify a clinical diagnosis. When appropriately conducted as academic research, including acknowledgment of inherent limitations, psychological profiles do not implicate the Goldwater Rule by drawing clinical conclusions outside clinical practice.

Dr. Lori H. Kels
The duty to warn is inapposite where there is no confidentiality to be breached. It also defies logic where the physician, far from being the only one who can alert another to danger based on clinically derived insight, is working solely from public sources and may actually know less, not more, than others.

Ultimately, the debate over the Goldwater Rule pits concerns over professional standards and respect for persons against the ability of psychiatrists to apply the expertise and language of their profession according to their own best judgment, without running afoul of an ethical norm. The premise that the Tarasoff principle overrides the Goldwater Rule is a red herring that does a disservice to both. There may be valid reasons to reevaluate the Goldwater Rule, but the duty to warn is not one of them.
 

Lt. Col. Charles G. Kels practices health and disability law in the U.S. Air Force. Dr. Lori H. Kels teaches and practices psychiatry at the University of the Incarnate Word School of Osteopathic Medicine in San Antonio. Opinions expressed in this article are those of the authors alone and do not necessarily reflect those of the Air Force or Department of Defense.

References

1. Goldwater v. Ginzburg, 414 F2d 324 (2d Cir 1969), cert denied, 396 US 1049 (1970).

2. APA Principles of Medical Ethics, 2013 ed. [7.3].

3. American Psychological Association Ethical Principles of Psychologists and Code of Ethics, 2016 ed. [9.01b].

4. The New York Times. Feb. 14, 2017.

5. The New York Times. Feb. 15, 2017.

6. Tarasoff v. Regents of University of California, 551 P2d 334 (Cal. 1976).

7. AMA Code of Medical Ethics, 2017 ed. [3.2.1(e) Confidentiality].

8. 45 Code of Federal Regulations 164.512(j)

9. JAMA. 2008;300(11):1348-50.

10. Psychiatr Clin North Am. 2002;25(3):A635-A46.

11. APA Opinions of the Ethics Committee, 2017 ed. [Q.7.a].

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The campaign, election, and administration of President Donald Trump have reinvigorated debate over rule 7.3 of the American Psychiatric Association (APA) code of ethics. Known as the Goldwater Rule for its historical roots in a magazine profile and subsequent libel suit by the 1964 Republican presidential nominee,1 this standard deems it unethical for a psychiatrist to offer a professional opinion of a public figure without conducting an examination and obtaining authorization.2 The American Psychological Association similarly provides that assessments must be based on adequate examination of the individual.3

Growing controversy

Shortly after President Trump’s inauguration, a group of 35 mental health professionals penned a letter in the New York Times stating that he was “incapable of serving safely as president.” Importantly, the writers couched their conclusions in professional expertise and specifically criticized the Goldwater Rule as having subjected their colleagues to self-imposed silence.4 A prominent psychiatrist, Allen J. Frances, MD, responded the following day to caution against “psychiatric name-calling” as a substitute for political action.5

Since then, psychiatrists classifying the APA ethics position as a “gag rule” preventing them from performing a public service have garnered considerable press coverage. When the American Psychoanalytic Association (APsaA) reiterated this summer that only APA members are bound by the Goldwater Rule, Boston Globe Media’s STAT news outlet misreported it as a license for psychiatrists to disregard the standard. Amid the ensuing media storm, the APsaA was forced to clarify that it was not countenancing defiance of psychiatry’s flagship organization and that its own longstanding policy remained unchanged.

Among those chafing against the Goldwater Rule in the current political environment, a call to arms has been the profession’s supposed “duty to warn” the public of the president’s mental health. This rationale was made explicit in an eponymous online movement and town hall forum hosted by Bandy X. Lee, MD, MDiv, a member of Yale University’s psychiatry faculty. According to these critics, an inherent tension exists between the Goldwater Rule’s prohibition on volunteering professional opinions from afar and the imperative to warn about the dangers posed by a leader with mental illness.
 

The duty to warn

Clinicians’ obligation to warn third parties when patients make credible threats or pose a high risk of harm emanates from various state laws, court decisions, and professional ethics rules. In the seminal Tarasoff case, a patient divulged in the course of psychotherapy his plan to murder a fellow student who had rejected his romantic overtures; campus police were alerted, but the intended victim was not. After the plan came to fruition, the California Supreme Court held that therapists must exercise reasonable care to protect “foreseeable victims” where they know or should know that a patient poses a serious danger.6

Although a controversial and massive expansion of tort liability 40 years ago, the basic tenets of Tarasoff have since been adopted by numerous courts, state legislatures, and professional organizations. The American Medical Association (AMA) recognizes an exception to confidentiality to mitigate serious threats of harm to the patient or other identifiable individuals.7 To enable health care professionals to operate in a way that is consistent with these standards, the HIPAA Privacy Rule expressly permits doctors to disclose protected health information, including psychotherapy notes, if the disclosure “is necessary to prevent or lessen a serious and imminent threat to the health or safety of a person or the public.”8

In terms of both professional ethics and privacy law, the duty to warn is framed as a limited and enumerated exception to the general rule that patient communications must be kept in confidence. In the absence of a clinician’s being privy to personal details about a patient via interview and examination, the duty to warn loses all coherence. It is precisely the intimacy of the doctor-patient relationship that gives rise to the fiduciary duty of confidentiality, which in turn must yield to public safety in rare situations where a credible threat is issued against an identifiable victim.
 

Origins of a misconception

Unlike the duty to warn, the Goldwater Rule is neither premised on nor a departure from the dictates of confidentiality. The rule is codified under the section of the APA ethics standards dealing with community and public health activities, not patient privacy. In nearly all cases where the Goldwater Rule could be invoked, the fundamental issue is that no examination has occurred. If it had, informed consent would be required for treatment, and appropriate authorization would be required for disclosure. Moreover, talking with the media – as opposed to alerting law enforcement, family members, or the subject of a threat – would almost never qualify as an appropriate outlet for discharging a physician’s duty to warn.

 

 

Whatever its merits, the Goldwater Rule is intended to distinguish between educational activities – in which psychiatrists share their expertise with the public and shed light on mental illness – and professional opinion wherein psychiatrists offer diagnoses or prognoses unsolicited by the individual.9

Lt. Col. Charles G. Kels
Today’s critics often point to psychological profiling commissioned by government agencies as a reason for the Goldwater Rule’s obsolescence. During the first Gulf War, Jerrold M. Post, MD, a pioneer in this field, compiled a detailed profile and offered Senate testimony on Iraqi dictator Saddam Hussein’s “malignant narcissism.” Dr. Post cited a Tarasoff-inspired justification for his actions, maintaining that his psychiatric expertise could save lives.10

The APA has since clarified that the Goldwater Rule does not prohibit “psychologically informed leadership studies” so long as they maintain scholarly standards and do not specify a clinical diagnosis. When appropriately conducted as academic research, including acknowledgment of inherent limitations, psychological profiles do not implicate the Goldwater Rule by drawing clinical conclusions outside clinical practice.

Dr. Lori H. Kels
The duty to warn is inapposite where there is no confidentiality to be breached. It also defies logic where the physician, far from being the only one who can alert another to danger based on clinically derived insight, is working solely from public sources and may actually know less, not more, than others.

Ultimately, the debate over the Goldwater Rule pits concerns over professional standards and respect for persons against the ability of psychiatrists to apply the expertise and language of their profession according to their own best judgment, without running afoul of an ethical norm. The premise that the Tarasoff principle overrides the Goldwater Rule is a red herring that does a disservice to both. There may be valid reasons to reevaluate the Goldwater Rule, but the duty to warn is not one of them.
 

Lt. Col. Charles G. Kels practices health and disability law in the U.S. Air Force. Dr. Lori H. Kels teaches and practices psychiatry at the University of the Incarnate Word School of Osteopathic Medicine in San Antonio. Opinions expressed in this article are those of the authors alone and do not necessarily reflect those of the Air Force or Department of Defense.

References

1. Goldwater v. Ginzburg, 414 F2d 324 (2d Cir 1969), cert denied, 396 US 1049 (1970).

2. APA Principles of Medical Ethics, 2013 ed. [7.3].

3. American Psychological Association Ethical Principles of Psychologists and Code of Ethics, 2016 ed. [9.01b].

4. The New York Times. Feb. 14, 2017.

5. The New York Times. Feb. 15, 2017.

6. Tarasoff v. Regents of University of California, 551 P2d 334 (Cal. 1976).

7. AMA Code of Medical Ethics, 2017 ed. [3.2.1(e) Confidentiality].

8. 45 Code of Federal Regulations 164.512(j)

9. JAMA. 2008;300(11):1348-50.

10. Psychiatr Clin North Am. 2002;25(3):A635-A46.

11. APA Opinions of the Ethics Committee, 2017 ed. [Q.7.a].

 

The campaign, election, and administration of President Donald Trump have reinvigorated debate over rule 7.3 of the American Psychiatric Association (APA) code of ethics. Known as the Goldwater Rule for its historical roots in a magazine profile and subsequent libel suit by the 1964 Republican presidential nominee,1 this standard deems it unethical for a psychiatrist to offer a professional opinion of a public figure without conducting an examination and obtaining authorization.2 The American Psychological Association similarly provides that assessments must be based on adequate examination of the individual.3

Growing controversy

Shortly after President Trump’s inauguration, a group of 35 mental health professionals penned a letter in the New York Times stating that he was “incapable of serving safely as president.” Importantly, the writers couched their conclusions in professional expertise and specifically criticized the Goldwater Rule as having subjected their colleagues to self-imposed silence.4 A prominent psychiatrist, Allen J. Frances, MD, responded the following day to caution against “psychiatric name-calling” as a substitute for political action.5

Since then, psychiatrists classifying the APA ethics position as a “gag rule” preventing them from performing a public service have garnered considerable press coverage. When the American Psychoanalytic Association (APsaA) reiterated this summer that only APA members are bound by the Goldwater Rule, Boston Globe Media’s STAT news outlet misreported it as a license for psychiatrists to disregard the standard. Amid the ensuing media storm, the APsaA was forced to clarify that it was not countenancing defiance of psychiatry’s flagship organization and that its own longstanding policy remained unchanged.

Among those chafing against the Goldwater Rule in the current political environment, a call to arms has been the profession’s supposed “duty to warn” the public of the president’s mental health. This rationale was made explicit in an eponymous online movement and town hall forum hosted by Bandy X. Lee, MD, MDiv, a member of Yale University’s psychiatry faculty. According to these critics, an inherent tension exists between the Goldwater Rule’s prohibition on volunteering professional opinions from afar and the imperative to warn about the dangers posed by a leader with mental illness.
 

The duty to warn

Clinicians’ obligation to warn third parties when patients make credible threats or pose a high risk of harm emanates from various state laws, court decisions, and professional ethics rules. In the seminal Tarasoff case, a patient divulged in the course of psychotherapy his plan to murder a fellow student who had rejected his romantic overtures; campus police were alerted, but the intended victim was not. After the plan came to fruition, the California Supreme Court held that therapists must exercise reasonable care to protect “foreseeable victims” where they know or should know that a patient poses a serious danger.6

Although a controversial and massive expansion of tort liability 40 years ago, the basic tenets of Tarasoff have since been adopted by numerous courts, state legislatures, and professional organizations. The American Medical Association (AMA) recognizes an exception to confidentiality to mitigate serious threats of harm to the patient or other identifiable individuals.7 To enable health care professionals to operate in a way that is consistent with these standards, the HIPAA Privacy Rule expressly permits doctors to disclose protected health information, including psychotherapy notes, if the disclosure “is necessary to prevent or lessen a serious and imminent threat to the health or safety of a person or the public.”8

In terms of both professional ethics and privacy law, the duty to warn is framed as a limited and enumerated exception to the general rule that patient communications must be kept in confidence. In the absence of a clinician’s being privy to personal details about a patient via interview and examination, the duty to warn loses all coherence. It is precisely the intimacy of the doctor-patient relationship that gives rise to the fiduciary duty of confidentiality, which in turn must yield to public safety in rare situations where a credible threat is issued against an identifiable victim.
 

Origins of a misconception

Unlike the duty to warn, the Goldwater Rule is neither premised on nor a departure from the dictates of confidentiality. The rule is codified under the section of the APA ethics standards dealing with community and public health activities, not patient privacy. In nearly all cases where the Goldwater Rule could be invoked, the fundamental issue is that no examination has occurred. If it had, informed consent would be required for treatment, and appropriate authorization would be required for disclosure. Moreover, talking with the media – as opposed to alerting law enforcement, family members, or the subject of a threat – would almost never qualify as an appropriate outlet for discharging a physician’s duty to warn.

 

 

Whatever its merits, the Goldwater Rule is intended to distinguish between educational activities – in which psychiatrists share their expertise with the public and shed light on mental illness – and professional opinion wherein psychiatrists offer diagnoses or prognoses unsolicited by the individual.9

Lt. Col. Charles G. Kels
Today’s critics often point to psychological profiling commissioned by government agencies as a reason for the Goldwater Rule’s obsolescence. During the first Gulf War, Jerrold M. Post, MD, a pioneer in this field, compiled a detailed profile and offered Senate testimony on Iraqi dictator Saddam Hussein’s “malignant narcissism.” Dr. Post cited a Tarasoff-inspired justification for his actions, maintaining that his psychiatric expertise could save lives.10

The APA has since clarified that the Goldwater Rule does not prohibit “psychologically informed leadership studies” so long as they maintain scholarly standards and do not specify a clinical diagnosis. When appropriately conducted as academic research, including acknowledgment of inherent limitations, psychological profiles do not implicate the Goldwater Rule by drawing clinical conclusions outside clinical practice.

Dr. Lori H. Kels
The duty to warn is inapposite where there is no confidentiality to be breached. It also defies logic where the physician, far from being the only one who can alert another to danger based on clinically derived insight, is working solely from public sources and may actually know less, not more, than others.

Ultimately, the debate over the Goldwater Rule pits concerns over professional standards and respect for persons against the ability of psychiatrists to apply the expertise and language of their profession according to their own best judgment, without running afoul of an ethical norm. The premise that the Tarasoff principle overrides the Goldwater Rule is a red herring that does a disservice to both. There may be valid reasons to reevaluate the Goldwater Rule, but the duty to warn is not one of them.
 

Lt. Col. Charles G. Kels practices health and disability law in the U.S. Air Force. Dr. Lori H. Kels teaches and practices psychiatry at the University of the Incarnate Word School of Osteopathic Medicine in San Antonio. Opinions expressed in this article are those of the authors alone and do not necessarily reflect those of the Air Force or Department of Defense.

References

1. Goldwater v. Ginzburg, 414 F2d 324 (2d Cir 1969), cert denied, 396 US 1049 (1970).

2. APA Principles of Medical Ethics, 2013 ed. [7.3].

3. American Psychological Association Ethical Principles of Psychologists and Code of Ethics, 2016 ed. [9.01b].

4. The New York Times. Feb. 14, 2017.

5. The New York Times. Feb. 15, 2017.

6. Tarasoff v. Regents of University of California, 551 P2d 334 (Cal. 1976).

7. AMA Code of Medical Ethics, 2017 ed. [3.2.1(e) Confidentiality].

8. 45 Code of Federal Regulations 164.512(j)

9. JAMA. 2008;300(11):1348-50.

10. Psychiatr Clin North Am. 2002;25(3):A635-A46.

11. APA Opinions of the Ethics Committee, 2017 ed. [Q.7.a].

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G. lamblia assemblage B more common in HIV-positive people

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G. lamblia assemblage B more common in HIV-positive people

 

The intestinal parasite Giardia lamblia assemblage B was more likely in people with HIV than in people without HIV, according to research published in Acta Tropica.

Of the 65 patients with G. lamblia included in a study undertaken by Clarissa Perez Faria, PhD, and her associates at the University of Coimbra (Portugal), 38 were HIV positive, 27 were HIV negative, and 60 patients were microscopy-positive for G. lamblia. In the HIV-positive group, 19 of the 34 microscopy-positive samples were assemblage B, and 15 were assemblage A. In the HIV-negative group, 9 of the 26 microscopy-positive samples were assemblage B, and 17 were assemblage A.

In HIV-positive patients with assemblage B G. lamblia, nine had CD4 T-cell count below 200 cells/mm3. Also, of the 21 cases which were symptomatic, 16 were in HIV-positive patients, and 11 of those 16 were assemblage B. The researchers said assemblage B infection is associated particularly with symptoms such as abdominal pain, asthenia, diarrhea, fever, headache, and myalgia.

“HIV infection increases the risk of having intestinal parasitic infections, including G. lamblia. The detection and treatment of infections are important measures to improve the quality of life of HIV-infected patients,” the investigators concluded.

Find the full study in Acta Tropica (doi: 10.1016/j.actatropica.2017.04.026).

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The intestinal parasite Giardia lamblia assemblage B was more likely in people with HIV than in people without HIV, according to research published in Acta Tropica.

Of the 65 patients with G. lamblia included in a study undertaken by Clarissa Perez Faria, PhD, and her associates at the University of Coimbra (Portugal), 38 were HIV positive, 27 were HIV negative, and 60 patients were microscopy-positive for G. lamblia. In the HIV-positive group, 19 of the 34 microscopy-positive samples were assemblage B, and 15 were assemblage A. In the HIV-negative group, 9 of the 26 microscopy-positive samples were assemblage B, and 17 were assemblage A.

In HIV-positive patients with assemblage B G. lamblia, nine had CD4 T-cell count below 200 cells/mm3. Also, of the 21 cases which were symptomatic, 16 were in HIV-positive patients, and 11 of those 16 were assemblage B. The researchers said assemblage B infection is associated particularly with symptoms such as abdominal pain, asthenia, diarrhea, fever, headache, and myalgia.

“HIV infection increases the risk of having intestinal parasitic infections, including G. lamblia. The detection and treatment of infections are important measures to improve the quality of life of HIV-infected patients,” the investigators concluded.

Find the full study in Acta Tropica (doi: 10.1016/j.actatropica.2017.04.026).

 

The intestinal parasite Giardia lamblia assemblage B was more likely in people with HIV than in people without HIV, according to research published in Acta Tropica.

Of the 65 patients with G. lamblia included in a study undertaken by Clarissa Perez Faria, PhD, and her associates at the University of Coimbra (Portugal), 38 were HIV positive, 27 were HIV negative, and 60 patients were microscopy-positive for G. lamblia. In the HIV-positive group, 19 of the 34 microscopy-positive samples were assemblage B, and 15 were assemblage A. In the HIV-negative group, 9 of the 26 microscopy-positive samples were assemblage B, and 17 were assemblage A.

In HIV-positive patients with assemblage B G. lamblia, nine had CD4 T-cell count below 200 cells/mm3. Also, of the 21 cases which were symptomatic, 16 were in HIV-positive patients, and 11 of those 16 were assemblage B. The researchers said assemblage B infection is associated particularly with symptoms such as abdominal pain, asthenia, diarrhea, fever, headache, and myalgia.

“HIV infection increases the risk of having intestinal parasitic infections, including G. lamblia. The detection and treatment of infections are important measures to improve the quality of life of HIV-infected patients,” the investigators concluded.

Find the full study in Acta Tropica (doi: 10.1016/j.actatropica.2017.04.026).

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Early births stress dads too

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– The anxiety of a preterm birth affects fathers just as much as it does mothers, significantly increasing depression rates both before and after the baby arrives.

More than one-third of fathers developed depression after their partners were admitted to a hospital with signs of impending preterm labor – similar to the percentage of mothers who experienced depression during that time, Sally Schulze reported at the meeting of the World Psychiatric Association.

Michele Sullivan/Frontline Medical News
Sally Schulze
“Fathers are also affected by the risk of preterm birth, and the risk seemed to continue to exert psychological strain, even among fathers whose partners went on to have a normal-term delivery,” said Ms. Schulze, a psychologist who specializes in birth-related stress at Frankfurt University.

The increased prevalence of depression lingered, too, she said. Even at 6 months after the birth, the rate of depression among these men was 2.5 times higher than in the general population.

Ms. Schulze and her colleagues prospectively followed 69 couples in which the woman was admitted to the hospital at high risk of preterm birth. These women had a mean gestational age of 30 weeks and had symptoms of imminent preterm birth: shortening of the cervix, premature rupture of membranes, or active preterm labor. Ms. Schulze compared this group to 49 control couples with no signs of preterm labor, who had come to the hospital to register for a birth at a mean of 35 weeks’ gestation.

The majority of the pregnancies were singletons; there were two twin pregnancies, but no high-order multiples. Couples whose infant died were later excluded from the study.

Both mothers and fathers completed the Edinburg Postnatal Depression Scale at baseline, and at 6 weeks and 6 months after the birth. The survey has been validated for perinatal use. A score of 10 or higher is considered positive for depression.

She divided the preterm birth risk group into two subgroups: couples whose infant was born preterm (26) and couples who made it to term, either by staying in the hospital for treatment and observation, or after being stabilized and released home (27).

Upon admission to the hospital, 35% of the fathers in the preterm birth risk group scored positive for depression, compared with 8% of the fathers in the control group – a significant between-group difference.

“This is especially meaningful when we consider that the background rate of depression among men in Germany is 6%,” Ms. Schulze said. “So our control group fathers were right in line with that, but depression in the preterm birth fathers was significantly elevated.”

At 6 weeks’ postpartum, men in the preterm birth risk group still were experiencing significantly elevated rates of depression, compared with both the control group and the general population. The increase was apparent whether the infant had indeed been born early, or whether it made it to full term (12% and 15%, respectively). Both were significantly higher than the 5% rate among the control group fathers.

“We have to understand that these fathers are now 6 weeks at home with a healthy infant, but they are still experiencing the stress of being exposed to this risk of preterm birth,” Ms. Schulze said.

By 6 months, depression had eased off in fathers whose infants made it to term; at 5%, it was similar to the rate in the control group fathers (4%) and the general population. But many fathers whose babies came early still were experiencing depression (12%).

Ms. Schulze then compared the fathers’ experience to that of the mothers. At baseline, women at risk of preterm birth had exactly the same rate of depression as their partners (35%). However, depression also was elevated among women in the control group (18%). The background rate for depression among German women is 10%, Ms. Schulze said.

At 6 weeks’ postpartum, the timing of birth did not seem to matter as much to the mothers. Depression rates were similarly elevated in those who had a preterm birth and those who did not (25%, 28%). Both were significantly higher than the 17% rate in the control group.

At 6 months, things were leveling out some for these mothers, with depression present in 10% of the preterm birth group, 19% of the full-term birth group, and 13% of the control group.

“Men seem to suffer just as much stress from this experience as women do, although perhaps in a different trajectory,” Ms. Schulze said. “Although there may be different contributing factors, we believe that the psychological care offered to mothers at risk of preterm birth should also be extended to fathers.”

She had no financial disclosures.

 

 

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– The anxiety of a preterm birth affects fathers just as much as it does mothers, significantly increasing depression rates both before and after the baby arrives.

More than one-third of fathers developed depression after their partners were admitted to a hospital with signs of impending preterm labor – similar to the percentage of mothers who experienced depression during that time, Sally Schulze reported at the meeting of the World Psychiatric Association.

Michele Sullivan/Frontline Medical News
Sally Schulze
“Fathers are also affected by the risk of preterm birth, and the risk seemed to continue to exert psychological strain, even among fathers whose partners went on to have a normal-term delivery,” said Ms. Schulze, a psychologist who specializes in birth-related stress at Frankfurt University.

The increased prevalence of depression lingered, too, she said. Even at 6 months after the birth, the rate of depression among these men was 2.5 times higher than in the general population.

Ms. Schulze and her colleagues prospectively followed 69 couples in which the woman was admitted to the hospital at high risk of preterm birth. These women had a mean gestational age of 30 weeks and had symptoms of imminent preterm birth: shortening of the cervix, premature rupture of membranes, or active preterm labor. Ms. Schulze compared this group to 49 control couples with no signs of preterm labor, who had come to the hospital to register for a birth at a mean of 35 weeks’ gestation.

The majority of the pregnancies were singletons; there were two twin pregnancies, but no high-order multiples. Couples whose infant died were later excluded from the study.

Both mothers and fathers completed the Edinburg Postnatal Depression Scale at baseline, and at 6 weeks and 6 months after the birth. The survey has been validated for perinatal use. A score of 10 or higher is considered positive for depression.

She divided the preterm birth risk group into two subgroups: couples whose infant was born preterm (26) and couples who made it to term, either by staying in the hospital for treatment and observation, or after being stabilized and released home (27).

Upon admission to the hospital, 35% of the fathers in the preterm birth risk group scored positive for depression, compared with 8% of the fathers in the control group – a significant between-group difference.

“This is especially meaningful when we consider that the background rate of depression among men in Germany is 6%,” Ms. Schulze said. “So our control group fathers were right in line with that, but depression in the preterm birth fathers was significantly elevated.”

At 6 weeks’ postpartum, men in the preterm birth risk group still were experiencing significantly elevated rates of depression, compared with both the control group and the general population. The increase was apparent whether the infant had indeed been born early, or whether it made it to full term (12% and 15%, respectively). Both were significantly higher than the 5% rate among the control group fathers.

“We have to understand that these fathers are now 6 weeks at home with a healthy infant, but they are still experiencing the stress of being exposed to this risk of preterm birth,” Ms. Schulze said.

By 6 months, depression had eased off in fathers whose infants made it to term; at 5%, it was similar to the rate in the control group fathers (4%) and the general population. But many fathers whose babies came early still were experiencing depression (12%).

Ms. Schulze then compared the fathers’ experience to that of the mothers. At baseline, women at risk of preterm birth had exactly the same rate of depression as their partners (35%). However, depression also was elevated among women in the control group (18%). The background rate for depression among German women is 10%, Ms. Schulze said.

At 6 weeks’ postpartum, the timing of birth did not seem to matter as much to the mothers. Depression rates were similarly elevated in those who had a preterm birth and those who did not (25%, 28%). Both were significantly higher than the 17% rate in the control group.

At 6 months, things were leveling out some for these mothers, with depression present in 10% of the preterm birth group, 19% of the full-term birth group, and 13% of the control group.

“Men seem to suffer just as much stress from this experience as women do, although perhaps in a different trajectory,” Ms. Schulze said. “Although there may be different contributing factors, we believe that the psychological care offered to mothers at risk of preterm birth should also be extended to fathers.”

She had no financial disclosures.

 

 

 

– The anxiety of a preterm birth affects fathers just as much as it does mothers, significantly increasing depression rates both before and after the baby arrives.

More than one-third of fathers developed depression after their partners were admitted to a hospital with signs of impending preterm labor – similar to the percentage of mothers who experienced depression during that time, Sally Schulze reported at the meeting of the World Psychiatric Association.

Michele Sullivan/Frontline Medical News
Sally Schulze
“Fathers are also affected by the risk of preterm birth, and the risk seemed to continue to exert psychological strain, even among fathers whose partners went on to have a normal-term delivery,” said Ms. Schulze, a psychologist who specializes in birth-related stress at Frankfurt University.

The increased prevalence of depression lingered, too, she said. Even at 6 months after the birth, the rate of depression among these men was 2.5 times higher than in the general population.

Ms. Schulze and her colleagues prospectively followed 69 couples in which the woman was admitted to the hospital at high risk of preterm birth. These women had a mean gestational age of 30 weeks and had symptoms of imminent preterm birth: shortening of the cervix, premature rupture of membranes, or active preterm labor. Ms. Schulze compared this group to 49 control couples with no signs of preterm labor, who had come to the hospital to register for a birth at a mean of 35 weeks’ gestation.

The majority of the pregnancies were singletons; there were two twin pregnancies, but no high-order multiples. Couples whose infant died were later excluded from the study.

Both mothers and fathers completed the Edinburg Postnatal Depression Scale at baseline, and at 6 weeks and 6 months after the birth. The survey has been validated for perinatal use. A score of 10 or higher is considered positive for depression.

She divided the preterm birth risk group into two subgroups: couples whose infant was born preterm (26) and couples who made it to term, either by staying in the hospital for treatment and observation, or after being stabilized and released home (27).

Upon admission to the hospital, 35% of the fathers in the preterm birth risk group scored positive for depression, compared with 8% of the fathers in the control group – a significant between-group difference.

“This is especially meaningful when we consider that the background rate of depression among men in Germany is 6%,” Ms. Schulze said. “So our control group fathers were right in line with that, but depression in the preterm birth fathers was significantly elevated.”

At 6 weeks’ postpartum, men in the preterm birth risk group still were experiencing significantly elevated rates of depression, compared with both the control group and the general population. The increase was apparent whether the infant had indeed been born early, or whether it made it to full term (12% and 15%, respectively). Both were significantly higher than the 5% rate among the control group fathers.

“We have to understand that these fathers are now 6 weeks at home with a healthy infant, but they are still experiencing the stress of being exposed to this risk of preterm birth,” Ms. Schulze said.

By 6 months, depression had eased off in fathers whose infants made it to term; at 5%, it was similar to the rate in the control group fathers (4%) and the general population. But many fathers whose babies came early still were experiencing depression (12%).

Ms. Schulze then compared the fathers’ experience to that of the mothers. At baseline, women at risk of preterm birth had exactly the same rate of depression as their partners (35%). However, depression also was elevated among women in the control group (18%). The background rate for depression among German women is 10%, Ms. Schulze said.

At 6 weeks’ postpartum, the timing of birth did not seem to matter as much to the mothers. Depression rates were similarly elevated in those who had a preterm birth and those who did not (25%, 28%). Both were significantly higher than the 17% rate in the control group.

At 6 months, things were leveling out some for these mothers, with depression present in 10% of the preterm birth group, 19% of the full-term birth group, and 13% of the control group.

“Men seem to suffer just as much stress from this experience as women do, although perhaps in a different trajectory,” Ms. Schulze said. “Although there may be different contributing factors, we believe that the psychological care offered to mothers at risk of preterm birth should also be extended to fathers.”

She had no financial disclosures.

 

 

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Key clinical point: Fathers exposed to the stress of a preterm birth can develop a longstanding depression.

Major finding: Depression developed in 35% of men whose wives were admitted to the hospital for imminent preterm birth; elevated depression rates lingered for up to 6 months in these fathers.

Data source: The prospective study comprised 69 couples admitted for preterm birth risk, and 49 control couples.

Disclosures: Ms. Schulze had no financial disclosures.

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Intensive exercise didn’t improve glycemic control for obese pregnant women

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An intensive exercise intervention for obese pregnant women did not improve maternal glycemia, but did attenuate excessive gestational weight gain, according to the a single-center, randomized controlled trial published in Obstetrics & Gynecology.

The Healthy Eating, Exercise and Lifestyle Trial, conducted from November 2013 through April 2016 at the Coombe Women and Infants University Hospital in Dublin, randomized 88 pregnant women with a body mass index of 30 kg/m2 or greater at their first prenatal visit to either a medically supervised exercise program or to the control group. The intervention consisted of 50-60 minutes of exercise at least once per week, including resistance or weights and aerobic exercises (Obstet Gynecol. 2017;130:1001-10).

woman on scale
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The researchers found no difference in mean fasting plasma glucose between the control group (90.0 plus or minus 9.0 mg/dL) and the exercise group (93.6 plus or minus 7.2 mg/dL) at 24-28 weeks’ gestation (P = .13). The incidence of gestational diabetes also was not statistically different at 24-28 weeks’ gestation between the groups; 48.8% in the control group, compared with 58.1% in the exercise group (P= .51).

However, excessive gestational weight gain at 36 weeks’ gestation (greater than 9.1 kg) was lower in the exercise group at 22.2%, compared with 43.2% in the control group (P less than .05), Niamh Daly of Coombe Women and Infants University Hospital and her coauthors reported.

“Our study may have failed to improve maternal glycemia because the ideal time to begin such a program could be before pregnancy,” the researchers wrote. “Pregnant women who are obese, however, should be advised to exercise because it attenuates excessive gestational weight gain.”

The study was partially funded by Friends of the Coombe, a charity organization. The authors reported having no financial disclosures.

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An intensive exercise intervention for obese pregnant women did not improve maternal glycemia, but did attenuate excessive gestational weight gain, according to the a single-center, randomized controlled trial published in Obstetrics & Gynecology.

The Healthy Eating, Exercise and Lifestyle Trial, conducted from November 2013 through April 2016 at the Coombe Women and Infants University Hospital in Dublin, randomized 88 pregnant women with a body mass index of 30 kg/m2 or greater at their first prenatal visit to either a medically supervised exercise program or to the control group. The intervention consisted of 50-60 minutes of exercise at least once per week, including resistance or weights and aerobic exercises (Obstet Gynecol. 2017;130:1001-10).

woman on scale
Keith Brofsky/thinkstock
The researchers found no difference in mean fasting plasma glucose between the control group (90.0 plus or minus 9.0 mg/dL) and the exercise group (93.6 plus or minus 7.2 mg/dL) at 24-28 weeks’ gestation (P = .13). The incidence of gestational diabetes also was not statistically different at 24-28 weeks’ gestation between the groups; 48.8% in the control group, compared with 58.1% in the exercise group (P= .51).

However, excessive gestational weight gain at 36 weeks’ gestation (greater than 9.1 kg) was lower in the exercise group at 22.2%, compared with 43.2% in the control group (P less than .05), Niamh Daly of Coombe Women and Infants University Hospital and her coauthors reported.

“Our study may have failed to improve maternal glycemia because the ideal time to begin such a program could be before pregnancy,” the researchers wrote. “Pregnant women who are obese, however, should be advised to exercise because it attenuates excessive gestational weight gain.”

The study was partially funded by Friends of the Coombe, a charity organization. The authors reported having no financial disclosures.

 

An intensive exercise intervention for obese pregnant women did not improve maternal glycemia, but did attenuate excessive gestational weight gain, according to the a single-center, randomized controlled trial published in Obstetrics & Gynecology.

The Healthy Eating, Exercise and Lifestyle Trial, conducted from November 2013 through April 2016 at the Coombe Women and Infants University Hospital in Dublin, randomized 88 pregnant women with a body mass index of 30 kg/m2 or greater at their first prenatal visit to either a medically supervised exercise program or to the control group. The intervention consisted of 50-60 minutes of exercise at least once per week, including resistance or weights and aerobic exercises (Obstet Gynecol. 2017;130:1001-10).

woman on scale
Keith Brofsky/thinkstock
The researchers found no difference in mean fasting plasma glucose between the control group (90.0 plus or minus 9.0 mg/dL) and the exercise group (93.6 plus or minus 7.2 mg/dL) at 24-28 weeks’ gestation (P = .13). The incidence of gestational diabetes also was not statistically different at 24-28 weeks’ gestation between the groups; 48.8% in the control group, compared with 58.1% in the exercise group (P= .51).

However, excessive gestational weight gain at 36 weeks’ gestation (greater than 9.1 kg) was lower in the exercise group at 22.2%, compared with 43.2% in the control group (P less than .05), Niamh Daly of Coombe Women and Infants University Hospital and her coauthors reported.

“Our study may have failed to improve maternal glycemia because the ideal time to begin such a program could be before pregnancy,” the researchers wrote. “Pregnant women who are obese, however, should be advised to exercise because it attenuates excessive gestational weight gain.”

The study was partially funded by Friends of the Coombe, a charity organization. The authors reported having no financial disclosures.

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Key clinical point: Intensive exercise starting in early pregnancy did not improve maternal glycemia for obese women.

Major finding: There was no difference in mean fasting plasma glucose between the control group (90.0 plus or minus 9.0 mg/dL) and the exercise group (93.6 plus or minus 7.2 mg/dL) at 24-28 weeks’ gestation (P = .13).

Data source: A single-center, randomized controlled trial of 88 pregnant women with a BMI of 30 kg/m2 or greater.

Disclosures: The study was partially funded by Friends of the Coombe, a charity organization. The authors reported having no financial disclosures.

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