A public-private partnership, led by mental health advocate Patrick Kennedy and the head of the National Institute of Mental Health, Joshua Gordon, MD, PhD, want urgent action to address the wave of mental illness and suicide caused by COVID-19.

“Our country is in serious denial about the full impact of mental health in this country and certainly as part of this pandemic,” said former congressman Mr. Kennedy, cochair of the Action Alliance’s Mental Health & Suicide Prevention National Response to COVID-19, at a briefing unveiling the group’s new six-priority Action Plan.

“That’s reinforced when all we hear from is Dr. Fauci,” and only about the physical effects of the disease, said Mr. Kennedy, the founder of the Kennedy Forum, a nonprofit dedicated to changing the health system’s approach to mental health and substance use disorders.

“We’re seeing suffering on a whole new, unprecedented scale,” he said. Mr. Kennedy noted the huge effort to speed therapeutics and vaccines to the American public. “We need to bring that same sense of urgency to these deaths of despair hiding in plain sight.”

Dr. Gordon, NIMH’s director and a cochair of the National Response group, was also at the briefing.

“We know many people report experiencing symptoms of distress, including anxiety, sleep problems, depression, substance use, and suicidal thoughts at rates two to three times higher than we might expect in times before the pandemic. Just as the country has come together to mitigate the physical impacts of pandemic, we also have to identify how to mitigate the mental health impacts,” said Dr. Gordon.
 

Plan of action

Mr. Kennedy emphasized that it is crucial that federal lawmakers and regulators find a way to increase parity between mental and physical health.

Paramount in that effort would be ensuring stronger enforcement of the Mental Health Parity and Addiction Equity Act, he said.

That 1996 law requires health plans to ensure that benefits for physical and mental health were equivalent, but it has frequently been ignored. In 2019, a U.S. federal court found that one of the nation’s largest behavioral health insurers, United Behavioral Health, had been violating the law. Mr. Kennedy said he expects this decision to continue to have a positive impact on achieving parity.

In November, United was ordered by a federal judge to reprocess 67,000 claims that it illegally denied.

The Alliance’s Action Plan has six priorities:

• Change the national conversation about mental health and suicide.
• Increase access to evidence-based treatments for substance use and mental health disorders in specialty and primary care, and include better reimbursement for services and make permanent reimbursement for telehealth services.
• Increase the use of nonpunitive and supportive crisis intervention services, including keeping people out of the criminal justice system.
• Establish near real-time data collection systems to promptly identify changes in rates of suicide, overdose, and other key events, and of clusters or spikes.
• Ensure the equitable delivery of comprehensive and effective suicide prevention and mental health services for Black Americans, Latin Americans, American Indian/Alaskan Natives, LGBTQ individuals, and others disproportionately impacted by the pandemic.
• Invest in prevention and early intervention approaches that treat the root causes of suicide and mental health problems.

Uptick in distress

Dr. Gordon noted that recent data indicate that, although ED visits for children are still down in 2020, compared with previous years, mental health ED visits are back to prepandemic levels.

A September survey showed an increase in suicidal thoughts and attempts, anxiety, and depression pandemic in youth because of the pandemic. Almost one-quarter of those surveyed said they knew a peer who developed suicidal thoughts since the start of the pandemic and 5% reported making a suicide attempt themselves.

In early December, research reported in JAMA Psychiatry showed the overall rate of overdose-related cardiac arrests in 2020 was about 50% higher than trends in 2018 and 2019, and that all overdose-related incidents were about 17% above baseline in 2020.

COVID-19 also appears to be striking individuals who are living in behavioral health facilities, and some of those facilities are reducing inpatient care and other programs because they don’t have enough personal protective equipment, testing supplies, or staff to cope with the disease.

The facilities are not required to report infections to the federal government. Sen. Elizabeth Warren (D-Mass.), Rep. Carolyn Maloney (D-N.Y.), and Rep. Katie Porter (D-Calif.) issued a report based on their own offices’ survey of 10 large behavioral health program operators.

Eight of those operators – covering 376 facilities and more than 100,000 patients in 40 states and Puerto Rico – provided substantive responses.

More than half had at least one COVID case and 14% had large outbreaks of 10 or more cases. The infection rate for patients was in line with that of the general public.

A version of this article originally appeared on Medscape.com.

A public-private partnership, led by mental health advocate Patrick Kennedy and the head of the National Institute of Mental Health, Joshua Gordon, MD, PhD, want urgent action to address the wave of mental illness and suicide caused by COVID-19.

“Our country is in serious denial about the full impact of mental health in this country and certainly as part of this pandemic,” said former congressman Mr. Kennedy, cochair of the Action Alliance’s Mental Health & Suicide Prevention National Response to COVID-19, at a briefing unveiling the group’s new six-priority Action Plan.

“That’s reinforced when all we hear from is Dr. Fauci,” and only about the physical effects of the disease, said Mr. Kennedy, the founder of the Kennedy Forum, a nonprofit dedicated to changing the health system’s approach to mental health and substance use disorders.

“We’re seeing suffering on a whole new, unprecedented scale,” he said. Mr. Kennedy noted the huge effort to speed therapeutics and vaccines to the American public. “We need to bring that same sense of urgency to these deaths of despair hiding in plain sight.”

Dr. Gordon, NIMH’s director and a cochair of the National Response group, was also at the briefing.

“We know many people report experiencing symptoms of distress, including anxiety, sleep problems, depression, substance use, and suicidal thoughts at rates two to three times higher than we might expect in times before the pandemic. Just as the country has come together to mitigate the physical impacts of pandemic, we also have to identify how to mitigate the mental health impacts,” said Dr. Gordon.
 

Plan of action

Mr. Kennedy emphasized that it is crucial that federal lawmakers and regulators find a way to increase parity between mental and physical health.

Paramount in that effort would be ensuring stronger enforcement of the Mental Health Parity and Addiction Equity Act, he said.

That 1996 law requires health plans to ensure that benefits for physical and mental health were equivalent, but it has frequently been ignored. In 2019, a U.S. federal court found that one of the nation’s largest behavioral health insurers, United Behavioral Health, had been violating the law. Mr. Kennedy said he expects this decision to continue to have a positive impact on achieving parity.

In November, United was ordered by a federal judge to reprocess 67,000 claims that it illegally denied.

The Alliance’s Action Plan has six priorities:

• Change the national conversation about mental health and suicide.
• Increase access to evidence-based treatments for substance use and mental health disorders in specialty and primary care, and include better reimbursement for services and make permanent reimbursement for telehealth services.
• Increase the use of nonpunitive and supportive crisis intervention services, including keeping people out of the criminal justice system.
• Establish near real-time data collection systems to promptly identify changes in rates of suicide, overdose, and other key events, and of clusters or spikes.
• Ensure the equitable delivery of comprehensive and effective suicide prevention and mental health services for Black Americans, Latin Americans, American Indian/Alaskan Natives, LGBTQ individuals, and others disproportionately impacted by the pandemic.
• Invest in prevention and early intervention approaches that treat the root causes of suicide and mental health problems.

Uptick in distress

Dr. Gordon noted that recent data indicate that, although ED visits for children are still down in 2020, compared with previous years, mental health ED visits are back to prepandemic levels.

A September survey showed an increase in suicidal thoughts and attempts, anxiety, and depression pandemic in youth because of the pandemic. Almost one-quarter of those surveyed said they knew a peer who developed suicidal thoughts since the start of the pandemic and 5% reported making a suicide attempt themselves.

In early December, research reported in JAMA Psychiatry showed the overall rate of overdose-related cardiac arrests in 2020 was about 50% higher than trends in 2018 and 2019, and that all overdose-related incidents were about 17% above baseline in 2020.

COVID-19 also appears to be striking individuals who are living in behavioral health facilities, and some of those facilities are reducing inpatient care and other programs because they don’t have enough personal protective equipment, testing supplies, or staff to cope with the disease.

The facilities are not required to report infections to the federal government. Sen. Elizabeth Warren (D-Mass.), Rep. Carolyn Maloney (D-N.Y.), and Rep. Katie Porter (D-Calif.) issued a report based on their own offices’ survey of 10 large behavioral health program operators.

Eight of those operators – covering 376 facilities and more than 100,000 patients in 40 states and Puerto Rico – provided substantive responses.

More than half had at least one COVID case and 14% had large outbreaks of 10 or more cases. The infection rate for patients was in line with that of the general public.

A version of this article originally appeared on Medscape.com.

A public-private partnership, led by mental health advocate Patrick Kennedy and the head of the National Institute of Mental Health, Joshua Gordon, MD, PhD, want urgent action to address the wave of mental illness and suicide caused by COVID-19.

“Our country is in serious denial about the full impact of mental health in this country and certainly as part of this pandemic,” said former congressman Mr. Kennedy, cochair of the Action Alliance’s Mental Health & Suicide Prevention National Response to COVID-19, at a briefing unveiling the group’s new six-priority Action Plan.

“That’s reinforced when all we hear from is Dr. Fauci,” and only about the physical effects of the disease, said Mr. Kennedy, the founder of the Kennedy Forum, a nonprofit dedicated to changing the health system’s approach to mental health and substance use disorders.

“We’re seeing suffering on a whole new, unprecedented scale,” he said. Mr. Kennedy noted the huge effort to speed therapeutics and vaccines to the American public. “We need to bring that same sense of urgency to these deaths of despair hiding in plain sight.”

Dr. Gordon, NIMH’s director and a cochair of the National Response group, was also at the briefing.

“We know many people report experiencing symptoms of distress, including anxiety, sleep problems, depression, substance use, and suicidal thoughts at rates two to three times higher than we might expect in times before the pandemic. Just as the country has come together to mitigate the physical impacts of pandemic, we also have to identify how to mitigate the mental health impacts,” said Dr. Gordon.
 

Plan of action

Mr. Kennedy emphasized that it is crucial that federal lawmakers and regulators find a way to increase parity between mental and physical health.

Paramount in that effort would be ensuring stronger enforcement of the Mental Health Parity and Addiction Equity Act, he said.

That 1996 law requires health plans to ensure that benefits for physical and mental health were equivalent, but it has frequently been ignored. In 2019, a U.S. federal court found that one of the nation’s largest behavioral health insurers, United Behavioral Health, had been violating the law. Mr. Kennedy said he expects this decision to continue to have a positive impact on achieving parity.

In November, United was ordered by a federal judge to reprocess 67,000 claims that it illegally denied.

The Alliance’s Action Plan has six priorities:

• Change the national conversation about mental health and suicide.
• Increase access to evidence-based treatments for substance use and mental health disorders in specialty and primary care, and include better reimbursement for services and make permanent reimbursement for telehealth services.
• Increase the use of nonpunitive and supportive crisis intervention services, including keeping people out of the criminal justice system.
• Establish near real-time data collection systems to promptly identify changes in rates of suicide, overdose, and other key events, and of clusters or spikes.
• Ensure the equitable delivery of comprehensive and effective suicide prevention and mental health services for Black Americans, Latin Americans, American Indian/Alaskan Natives, LGBTQ individuals, and others disproportionately impacted by the pandemic.
• Invest in prevention and early intervention approaches that treat the root causes of suicide and mental health problems.

Uptick in distress

Dr. Gordon noted that recent data indicate that, although ED visits for children are still down in 2020, compared with previous years, mental health ED visits are back to prepandemic levels.

A September survey showed an increase in suicidal thoughts and attempts, anxiety, and depression pandemic in youth because of the pandemic. Almost one-quarter of those surveyed said they knew a peer who developed suicidal thoughts since the start of the pandemic and 5% reported making a suicide attempt themselves.

In early December, research reported in JAMA Psychiatry showed the overall rate of overdose-related cardiac arrests in 2020 was about 50% higher than trends in 2018 and 2019, and that all overdose-related incidents were about 17% above baseline in 2020.

COVID-19 also appears to be striking individuals who are living in behavioral health facilities, and some of those facilities are reducing inpatient care and other programs because they don’t have enough personal protective equipment, testing supplies, or staff to cope with the disease.

The facilities are not required to report infections to the federal government. Sen. Elizabeth Warren (D-Mass.), Rep. Carolyn Maloney (D-N.Y.), and Rep. Katie Porter (D-Calif.) issued a report based on their own offices’ survey of 10 large behavioral health program operators.

Eight of those operators – covering 376 facilities and more than 100,000 patients in 40 states and Puerto Rico – provided substantive responses.

More than half had at least one COVID case and 14% had large outbreaks of 10 or more cases. The infection rate for patients was in line with that of the general public.

A version of this article originally appeared on Medscape.com.

A family medicine trained doctor, fresh out of residency, visits a career website to scout out prospective hospitalist jobs in their region. As they scroll through the job listings, they come across one opportunity at a nearby hospital system that seems like a good fit. The listing offers a competitive salary and comprehensive benefits for the position, and mentions hospitalists in the department will have the opportunity to teach medical students.

The only problem? The position is for internal medicine trained doctors only. After searching through several more listings with the same internal medicine requirement, the pool of jobs available to the family medicine doctor seems much smaller.
When Robert M. Wachter, MD, MHM, and Lee Goldman, MD coined the term “hospitalist” in a 1996 New England Journal of Medicine article, hospitalists were primarily clinicians with an internal medicine background, filling the gap created by family medicine doctors who increasingly devoted their time to patients in their practice and spent less time rounding in the hospital.
As family medicine doctors have returned to hospital medicine, it has become difficult to find positions as hospitalists due to a preference by some recruiters and employers that favors internal medicine physicians over those who are trained in family medicine. The preference for internal medicine physicians is sometimes overt, such as a requirement on a job application. But the preference can also surface after a physician has already applied for a position, and they will then discover a recruiter is actually looking for someone with a background in internal medicine. In other cases, family medicine physicians find out after applying that applicants with a background in family medicine are considered, but they’re expected to have additional training or certification not listed on the job application. 
The situation can even be as stark as a hospital system hiring an internal medicine doctor just out of residency over a family medicine doctor with years of experience as a board-certified physician. Hiring practices in large systems across multiple states sometimes don’t just favor internal medicine, they are entirely focused on internal medicine hospitalists, said experts who spoke with The Hospitalist.

Outdated perceptions of family medicine

Victoria McCurry, MD, current chair of the Society of Hospital Medicine’s family medicine Special Interest Group (SIG) Executive Committee and Faculty Director of Inpatient Services at UPMC McKeesport (Pa.) Family Medicine Residency, said hearsay inside the family medicine community influenced her first job search looking for hospitalist positions as a family medicine physician.

Experience, education closes some gaps

Over the years, the American Board of Family Medicine (ABFM) and SHM have offered several opportunities for family medicine doctors to demonstrate their experience and training in hospital medicine. In 2010, ABFM began offering the Focused Recognition of Hospital Medicine board examination, together with the American Board of Internal Medicine. SHM also offers hospitalist fellowships and a designation of Fellow in Hospital Medicine (FHM) for health care professionals. In 2015, ABFM and SHM released a joint statement encouraging the growth of hospitalists trained in family medicine (HTFM) and outlining these opportunities.
These measures help fill a gap in both IM and FM training, but also appear to have some effect in convincing recruiters and employers to consider family medicine doctors for hospitalist positions. An abstract published at Hospital Medicine 2014 reviewed 252 hospitalist positions listed in journals and search engines attempted to document the disparities in job listings, the perceptions of physician recruiters, and how factors like experience, training, and certification impacted a family medicine physician’s likelihood to be considered for a position. HTFMs were explicitly mentioned as being eligible in 119 of 252 positions (47%). The investigators then sent surveys out to physician recruiters of the remaining 133 positions asking whether HTFMs were being considered for the position. The results of the survey showed 66% of the recruiters were open to HTFMs, while 34% of recruiters said they did not have a willingness to hire HTFMs. 
That willingness to hire changed based on the level of experience, training, and certification. More than one-fourth (29%) of physician recruiters said institutional bylaws prevented hiring of HTFMs. If respondents earned a Recognition of Focused Practice in Hospital Medicine (RFPHM) board examination, 78% of physician recruiters would reconsider hiring the candidate. If the HTFM applicant had prior experience in hospital medicine, 87% of physician recruiters said they would consider the candidate. HTFMs who earned a Designation of Fellow in Hospital Medicine (FHM) from SHM would be reconsidered by 93% of physician recruiters who initially refused the HTFM candidate. All physician recruiters said they would reconsider if the candidate had a fellowship in hospital medicine.
However, to date, there is no official American College of Graduate Medical Education (ACGME)-recognized hospitalist board certification or designated specialty credentialing. This can lead to situations where family medicine trained physicians are applying for jobs without the necessary requirements for the position, because those requirements may not be immediately obvious when first applying to a position. “There’s often no specification until you apply and then are informed that you don’t qualify – ‘Oh, no, you  haven’t completed a fellowship,’ or the added qualification in hospital medicine,” Dr. McCurry said.
The 2015 joint statement from AAFP and SHM asserts that “more than two-thirds of HTFMs are also involved in the training of residents and medical students, enhancing the skills of our future physicians.” But when HTFMs do find positions, they may be limited in other ways, such as being prohibited from serving on the faculty of internal medicine residency programs and teaching internal medicine residents. When Dr. Odeti was medical director for Johnston Memorial Hospital in Abingdon, Va., he said he encountered this issue.
“If you are a hospitalist who is internal medicine trained, then you can teach FM or IM, whereas if you’re family medicine trained, you cannot teach internal medicine residents,” he said. “What happened with me, I had to prioritize recruiting internal medicine residents over FM residents to be able to staff IM teaching faculty.”
A rule change has been lobbied by SHM, under the direction of SHM family medicine SIG former chair David Goldstein, MD, to address this issue that would allow HTFMs with a FPHM designation to teach IM residents. The change was quietly made by the ACGME Review Committee for Internal Medicine in 2017, Dr. McCurry said, but implementation of the change has been slow.
“Essentially, the change was made in 2017 to allow for family medicine trainied physicians who have the FPHM designation to teach IM residents, but this knowledge has not been widely dispersed or policies updated to clearly reflect this change,” Dr. McCurry said. “It is a significant change, however, because prior to that, there were explicit policies preventing a family medicine hospitalist from teaching internal medicine residents even if they were experienced.”

FM physicians uniquely suited for HM

Requirements aside, it is “arguably not the case” that family medicine physicians need these extra certifications and fellowships to serve as hospitalists, Dr. McCurry said. It is difficult to quantify IM and FM hospitalist quality outcomes due to challenges with attribution, Dr. Odeti noted. One 2007 study published in the New England Journal of Medicine looked at patient quality and cost of care across the hospitalist model, and family medicine practitioners providing inpatients care. The investigators found similar outcomes in the internist model and with family practitioners providing inpatient care. Dr. Odeti said this research supports “the fact that family medicine physicians are equally competent as internists in providing inpatient care.”

HTFMs are growing within SHM

HTFMs are “all over,” being represented in smaller hospitals, larger hospitals, and university hospitals in every state. “But to reach those positions, they probably have to go over more hurdles and have fewer opportunities,” Dr. Chaudhry said.
There isn’t a completely accurate count of family medicine hospitalists in the United States. Out of an estimated 50,000 hospitalists in the U. S., about 16,000 hospitalists are members of SHM. A number of family medicine hospitalists may also take AAFP membership instead of SHM, Dr. Odeti explained.
However, there are a growing number of hospitalists within SHM with a family medicine background. In the 2007-2008 Society of Hospital Medicine Annual Survey, 3.7% of U.S. hospitalists claimed family medicine training. That number increased to 6.9% of physicians who answered the SHM membership data report in 2010.
A Medscape Hospitalist Lifestyle, Happiness & Burnout Report from 2019 estimates 17% of hospitalists are trained in family medicine. In the latest State of Hospital Medicine Report published in 2020, 38.6% of hospital medicine groups containing family medicine trained physicians were part of a university, medical school, or faculty practice; 79.6% did not have academic status; 83.8% were at a non-teaching hospital; 60.7% were in a group in a non-teaching service at a teaching hospital; and 52.8% were in a group at a combination teaching/non-teaching service at a teaching hospital.
Although the Report did not specify whether family medicine hospitalists were mainly in rural or urban areas, “some of us do practice in underserved area hospitals where you have the smaller ICU model, critical access hospitals, potentially dealing with a whole gamut of inpatient medicine from ER, to the hospital inpatient adult cases, to critical care level,” Dr. McCurry said. 
“But then, there are a large number of us who practice in private groups or at large hospitals, academic centers around the country,” she added. “There’s a range of family medicine trained hospitalist practice areas.”

Equal recognition for HTFM in HM

The SHM family medicine SIG has been working to highlight the issue of hiring practices for HTFMs, and is taking a number of actions to bring greater awareness and recognition to family medicine hospitalists.
The family medicine SIG is looking at steps for requesting a new joint statement from ABFM and SHM focused on hiring practices for family medicine physicians as hospitalists. “I think it’s worth considering now that we’re at a point where we comprise about one-fifth of hospitalists as family medicine docs,” Dr. McCurry said. “Is it time to take that joint statement to the next step, and seek a review of how we can improve the balance of hiring in terms of favoring more balanced consideration now that there are a lot more family medicine trained hospitalists than historically?
“I think the call is really to help us all move to that next step in terms of identifying any of the lingering vestiges of expectation that are really no longer applicable to the hiring practices, or shouldn’t be,” she said. 
The next step will be to ask hospitals with internal medicine only requirements for hospitalists to update their bylaws to include family medicine physicians when considering candidates for hospitalist positions. If SHM does not make a distinction to grant Fellow in Hospital Medicine status between internal medicine and family medicine trained hospitalists, “then there should not be any distinction, or there should not be any hindrance by the recruiters, by the bigger systems, as well as by the employers” in hiring a family medicine trained physician for a hospitalist position, Dr. Chaudhry said.
Dr. Odeti, who serves in several leadership roles within Ballad Health, describes the system as being friendly to HTFMs. About one-fourth of the hospitalists in Ballad Health are trained in family medicine. But when Dr. Odeti started his hospitalist practice, he was only one of a handful of HTFMs. He sees a future where the accomplishments and contributions of HTFMs will pave the way for future hospitalists. “Access into the urban hospitals is key, and I hope that SHM and the HTFM SIG will act as a catalyst for this change,” he said.
Colleagues of family medicine hospitalists, especially those in leadership positions at hospitals, can help by raising awareness, as can “those of our colleagues who sit on medical executive committees within their hospitals to review their bylaws, to see what the policies are, and encourage more competitiveness,” Dr. McCurry said. “Truly, the best candidate for the position, regardless of background and training, is what you want. You want the best colleagues for your fellow hospitalists. You want the best physician for your patients in the hospital.”
If training and all other things are equal, family medicine physicians should be evaluated on a case-by-case basis, she said. “I think that that puts the burden back on any good medical committee, and a good medical committee member who is an SHM member as well, to say, ‘If we are committed to quality patient care, we want to encourage the recruitment of all physicians that are truly the best physicians to reduce that distinction between FM and IM in order to allow those best candidates to present, whether they are FM or IM.’ That’s all that we’re asking.”
Dr. Chaudhry emphasized that the preference for internal medicine trained physicians isn’t intentional. “It’s not as if the systems are trying to do it,” he said. “I think it is more like everybody needs to be educated. And through the platform of the Society of Hospital Medicine, I think we can make a difference. It will be a slow change, but we’ll have to keep on working on it.”

Dr. Odeti, Dr. McCurry, and Dr. Chaudhry have no relevant financial disclosures.
 

A family medicine trained doctor, fresh out of residency, visits a career website to scout out prospective hospitalist jobs in their region. As they scroll through the job listings, they come across one opportunity at a nearby hospital system that seems like a good fit. The listing offers a competitive salary and comprehensive benefits for the position, and mentions hospitalists in the department will have the opportunity to teach medical students.

The only problem? The position is for internal medicine trained doctors only. After searching through several more listings with the same internal medicine requirement, the pool of jobs available to the family medicine doctor seems much smaller.
When Robert M. Wachter, MD, MHM, and Lee Goldman, MD coined the term “hospitalist” in a 1996 New England Journal of Medicine article, hospitalists were primarily clinicians with an internal medicine background, filling the gap created by family medicine doctors who increasingly devoted their time to patients in their practice and spent less time rounding in the hospital.
As family medicine doctors have returned to hospital medicine, it has become difficult to find positions as hospitalists due to a preference by some recruiters and employers that favors internal medicine physicians over those who are trained in family medicine. The preference for internal medicine physicians is sometimes overt, such as a requirement on a job application. But the preference can also surface after a physician has already applied for a position, and they will then discover a recruiter is actually looking for someone with a background in internal medicine. In other cases, family medicine physicians find out after applying that applicants with a background in family medicine are considered, but they’re expected to have additional training or certification not listed on the job application. 
The situation can even be as stark as a hospital system hiring an internal medicine doctor just out of residency over a family medicine doctor with years of experience as a board-certified physician. Hiring practices in large systems across multiple states sometimes don’t just favor internal medicine, they are entirely focused on internal medicine hospitalists, said experts who spoke with The Hospitalist.

Outdated perceptions of family medicine

Victoria McCurry, MD, current chair of the Society of Hospital Medicine’s family medicine Special Interest Group (SIG) Executive Committee and Faculty Director of Inpatient Services at UPMC McKeesport (Pa.) Family Medicine Residency, said hearsay inside the family medicine community influenced her first job search looking for hospitalist positions as a family medicine physician.

Experience, education closes some gaps

Over the years, the American Board of Family Medicine (ABFM) and SHM have offered several opportunities for family medicine doctors to demonstrate their experience and training in hospital medicine. In 2010, ABFM began offering the Focused Recognition of Hospital Medicine board examination, together with the American Board of Internal Medicine. SHM also offers hospitalist fellowships and a designation of Fellow in Hospital Medicine (FHM) for health care professionals. In 2015, ABFM and SHM released a joint statement encouraging the growth of hospitalists trained in family medicine (HTFM) and outlining these opportunities.
These measures help fill a gap in both IM and FM training, but also appear to have some effect in convincing recruiters and employers to consider family medicine doctors for hospitalist positions. An abstract published at Hospital Medicine 2014 reviewed 252 hospitalist positions listed in journals and search engines attempted to document the disparities in job listings, the perceptions of physician recruiters, and how factors like experience, training, and certification impacted a family medicine physician’s likelihood to be considered for a position. HTFMs were explicitly mentioned as being eligible in 119 of 252 positions (47%). The investigators then sent surveys out to physician recruiters of the remaining 133 positions asking whether HTFMs were being considered for the position. The results of the survey showed 66% of the recruiters were open to HTFMs, while 34% of recruiters said they did not have a willingness to hire HTFMs. 
That willingness to hire changed based on the level of experience, training, and certification. More than one-fourth (29%) of physician recruiters said institutional bylaws prevented hiring of HTFMs. If respondents earned a Recognition of Focused Practice in Hospital Medicine (RFPHM) board examination, 78% of physician recruiters would reconsider hiring the candidate. If the HTFM applicant had prior experience in hospital medicine, 87% of physician recruiters said they would consider the candidate. HTFMs who earned a Designation of Fellow in Hospital Medicine (FHM) from SHM would be reconsidered by 93% of physician recruiters who initially refused the HTFM candidate. All physician recruiters said they would reconsider if the candidate had a fellowship in hospital medicine.
However, to date, there is no official American College of Graduate Medical Education (ACGME)-recognized hospitalist board certification or designated specialty credentialing. This can lead to situations where family medicine trained physicians are applying for jobs without the necessary requirements for the position, because those requirements may not be immediately obvious when first applying to a position. “There’s often no specification until you apply and then are informed that you don’t qualify – ‘Oh, no, you  haven’t completed a fellowship,’ or the added qualification in hospital medicine,” Dr. McCurry said.
The 2015 joint statement from AAFP and SHM asserts that “more than two-thirds of HTFMs are also involved in the training of residents and medical students, enhancing the skills of our future physicians.” But when HTFMs do find positions, they may be limited in other ways, such as being prohibited from serving on the faculty of internal medicine residency programs and teaching internal medicine residents. When Dr. Odeti was medical director for Johnston Memorial Hospital in Abingdon, Va., he said he encountered this issue.
“If you are a hospitalist who is internal medicine trained, then you can teach FM or IM, whereas if you’re family medicine trained, you cannot teach internal medicine residents,” he said. “What happened with me, I had to prioritize recruiting internal medicine residents over FM residents to be able to staff IM teaching faculty.”
A rule change has been lobbied by SHM, under the direction of SHM family medicine SIG former chair David Goldstein, MD, to address this issue that would allow HTFMs with a FPHM designation to teach IM residents. The change was quietly made by the ACGME Review Committee for Internal Medicine in 2017, Dr. McCurry said, but implementation of the change has been slow.
“Essentially, the change was made in 2017 to allow for family medicine trainied physicians who have the FPHM designation to teach IM residents, but this knowledge has not been widely dispersed or policies updated to clearly reflect this change,” Dr. McCurry said. “It is a significant change, however, because prior to that, there were explicit policies preventing a family medicine hospitalist from teaching internal medicine residents even if they were experienced.”

FM physicians uniquely suited for HM

Requirements aside, it is “arguably not the case” that family medicine physicians need these extra certifications and fellowships to serve as hospitalists, Dr. McCurry said. It is difficult to quantify IM and FM hospitalist quality outcomes due to challenges with attribution, Dr. Odeti noted. One 2007 study published in the New England Journal of Medicine looked at patient quality and cost of care across the hospitalist model, and family medicine practitioners providing inpatients care. The investigators found similar outcomes in the internist model and with family practitioners providing inpatient care. Dr. Odeti said this research supports “the fact that family medicine physicians are equally competent as internists in providing inpatient care.”

HTFMs are growing within SHM

HTFMs are “all over,” being represented in smaller hospitals, larger hospitals, and university hospitals in every state. “But to reach those positions, they probably have to go over more hurdles and have fewer opportunities,” Dr. Chaudhry said.
There isn’t a completely accurate count of family medicine hospitalists in the United States. Out of an estimated 50,000 hospitalists in the U. S., about 16,000 hospitalists are members of SHM. A number of family medicine hospitalists may also take AAFP membership instead of SHM, Dr. Odeti explained.
However, there are a growing number of hospitalists within SHM with a family medicine background. In the 2007-2008 Society of Hospital Medicine Annual Survey, 3.7% of U.S. hospitalists claimed family medicine training. That number increased to 6.9% of physicians who answered the SHM membership data report in 2010.
A Medscape Hospitalist Lifestyle, Happiness & Burnout Report from 2019 estimates 17% of hospitalists are trained in family medicine. In the latest State of Hospital Medicine Report published in 2020, 38.6% of hospital medicine groups containing family medicine trained physicians were part of a university, medical school, or faculty practice; 79.6% did not have academic status; 83.8% were at a non-teaching hospital; 60.7% were in a group in a non-teaching service at a teaching hospital; and 52.8% were in a group at a combination teaching/non-teaching service at a teaching hospital.
Although the Report did not specify whether family medicine hospitalists were mainly in rural or urban areas, “some of us do practice in underserved area hospitals where you have the smaller ICU model, critical access hospitals, potentially dealing with a whole gamut of inpatient medicine from ER, to the hospital inpatient adult cases, to critical care level,” Dr. McCurry said. 
“But then, there are a large number of us who practice in private groups or at large hospitals, academic centers around the country,” she added. “There’s a range of family medicine trained hospitalist practice areas.”

Equal recognition for HTFM in HM

The SHM family medicine SIG has been working to highlight the issue of hiring practices for HTFMs, and is taking a number of actions to bring greater awareness and recognition to family medicine hospitalists.
The family medicine SIG is looking at steps for requesting a new joint statement from ABFM and SHM focused on hiring practices for family medicine physicians as hospitalists. “I think it’s worth considering now that we’re at a point where we comprise about one-fifth of hospitalists as family medicine docs,” Dr. McCurry said. “Is it time to take that joint statement to the next step, and seek a review of how we can improve the balance of hiring in terms of favoring more balanced consideration now that there are a lot more family medicine trained hospitalists than historically?
“I think the call is really to help us all move to that next step in terms of identifying any of the lingering vestiges of expectation that are really no longer applicable to the hiring practices, or shouldn’t be,” she said. 
The next step will be to ask hospitals with internal medicine only requirements for hospitalists to update their bylaws to include family medicine physicians when considering candidates for hospitalist positions. If SHM does not make a distinction to grant Fellow in Hospital Medicine status between internal medicine and family medicine trained hospitalists, “then there should not be any distinction, or there should not be any hindrance by the recruiters, by the bigger systems, as well as by the employers” in hiring a family medicine trained physician for a hospitalist position, Dr. Chaudhry said.
Dr. Odeti, who serves in several leadership roles within Ballad Health, describes the system as being friendly to HTFMs. About one-fourth of the hospitalists in Ballad Health are trained in family medicine. But when Dr. Odeti started his hospitalist practice, he was only one of a handful of HTFMs. He sees a future where the accomplishments and contributions of HTFMs will pave the way for future hospitalists. “Access into the urban hospitals is key, and I hope that SHM and the HTFM SIG will act as a catalyst for this change,” he said.
Colleagues of family medicine hospitalists, especially those in leadership positions at hospitals, can help by raising awareness, as can “those of our colleagues who sit on medical executive committees within their hospitals to review their bylaws, to see what the policies are, and encourage more competitiveness,” Dr. McCurry said. “Truly, the best candidate for the position, regardless of background and training, is what you want. You want the best colleagues for your fellow hospitalists. You want the best physician for your patients in the hospital.”
If training and all other things are equal, family medicine physicians should be evaluated on a case-by-case basis, she said. “I think that that puts the burden back on any good medical committee, and a good medical committee member who is an SHM member as well, to say, ‘If we are committed to quality patient care, we want to encourage the recruitment of all physicians that are truly the best physicians to reduce that distinction between FM and IM in order to allow those best candidates to present, whether they are FM or IM.’ That’s all that we’re asking.”
Dr. Chaudhry emphasized that the preference for internal medicine trained physicians isn’t intentional. “It’s not as if the systems are trying to do it,” he said. “I think it is more like everybody needs to be educated. And through the platform of the Society of Hospital Medicine, I think we can make a difference. It will be a slow change, but we’ll have to keep on working on it.”

Dr. Odeti, Dr. McCurry, and Dr. Chaudhry have no relevant financial disclosures.
 

A family medicine trained doctor, fresh out of residency, visits a career website to scout out prospective hospitalist jobs in their region. As they scroll through the job listings, they come across one opportunity at a nearby hospital system that seems like a good fit. The listing offers a competitive salary and comprehensive benefits for the position, and mentions hospitalists in the department will have the opportunity to teach medical students.

The only problem? The position is for internal medicine trained doctors only. After searching through several more listings with the same internal medicine requirement, the pool of jobs available to the family medicine doctor seems much smaller.
When Robert M. Wachter, MD, MHM, and Lee Goldman, MD coined the term “hospitalist” in a 1996 New England Journal of Medicine article, hospitalists were primarily clinicians with an internal medicine background, filling the gap created by family medicine doctors who increasingly devoted their time to patients in their practice and spent less time rounding in the hospital.
As family medicine doctors have returned to hospital medicine, it has become difficult to find positions as hospitalists due to a preference by some recruiters and employers that favors internal medicine physicians over those who are trained in family medicine. The preference for internal medicine physicians is sometimes overt, such as a requirement on a job application. But the preference can also surface after a physician has already applied for a position, and they will then discover a recruiter is actually looking for someone with a background in internal medicine. In other cases, family medicine physicians find out after applying that applicants with a background in family medicine are considered, but they’re expected to have additional training or certification not listed on the job application. 
The situation can even be as stark as a hospital system hiring an internal medicine doctor just out of residency over a family medicine doctor with years of experience as a board-certified physician. Hiring practices in large systems across multiple states sometimes don’t just favor internal medicine, they are entirely focused on internal medicine hospitalists, said experts who spoke with The Hospitalist.

Outdated perceptions of family medicine

Victoria McCurry, MD, current chair of the Society of Hospital Medicine’s family medicine Special Interest Group (SIG) Executive Committee and Faculty Director of Inpatient Services at UPMC McKeesport (Pa.) Family Medicine Residency, said hearsay inside the family medicine community influenced her first job search looking for hospitalist positions as a family medicine physician.

Experience, education closes some gaps

Over the years, the American Board of Family Medicine (ABFM) and SHM have offered several opportunities for family medicine doctors to demonstrate their experience and training in hospital medicine. In 2010, ABFM began offering the Focused Recognition of Hospital Medicine board examination, together with the American Board of Internal Medicine. SHM also offers hospitalist fellowships and a designation of Fellow in Hospital Medicine (FHM) for health care professionals. In 2015, ABFM and SHM released a joint statement encouraging the growth of hospitalists trained in family medicine (HTFM) and outlining these opportunities.
These measures help fill a gap in both IM and FM training, but also appear to have some effect in convincing recruiters and employers to consider family medicine doctors for hospitalist positions. An abstract published at Hospital Medicine 2014 reviewed 252 hospitalist positions listed in journals and search engines attempted to document the disparities in job listings, the perceptions of physician recruiters, and how factors like experience, training, and certification impacted a family medicine physician’s likelihood to be considered for a position. HTFMs were explicitly mentioned as being eligible in 119 of 252 positions (47%). The investigators then sent surveys out to physician recruiters of the remaining 133 positions asking whether HTFMs were being considered for the position. The results of the survey showed 66% of the recruiters were open to HTFMs, while 34% of recruiters said they did not have a willingness to hire HTFMs. 
That willingness to hire changed based on the level of experience, training, and certification. More than one-fourth (29%) of physician recruiters said institutional bylaws prevented hiring of HTFMs. If respondents earned a Recognition of Focused Practice in Hospital Medicine (RFPHM) board examination, 78% of physician recruiters would reconsider hiring the candidate. If the HTFM applicant had prior experience in hospital medicine, 87% of physician recruiters said they would consider the candidate. HTFMs who earned a Designation of Fellow in Hospital Medicine (FHM) from SHM would be reconsidered by 93% of physician recruiters who initially refused the HTFM candidate. All physician recruiters said they would reconsider if the candidate had a fellowship in hospital medicine.
However, to date, there is no official American College of Graduate Medical Education (ACGME)-recognized hospitalist board certification or designated specialty credentialing. This can lead to situations where family medicine trained physicians are applying for jobs without the necessary requirements for the position, because those requirements may not be immediately obvious when first applying to a position. “There’s often no specification until you apply and then are informed that you don’t qualify – ‘Oh, no, you  haven’t completed a fellowship,’ or the added qualification in hospital medicine,” Dr. McCurry said.
The 2015 joint statement from AAFP and SHM asserts that “more than two-thirds of HTFMs are also involved in the training of residents and medical students, enhancing the skills of our future physicians.” But when HTFMs do find positions, they may be limited in other ways, such as being prohibited from serving on the faculty of internal medicine residency programs and teaching internal medicine residents. When Dr. Odeti was medical director for Johnston Memorial Hospital in Abingdon, Va., he said he encountered this issue.
“If you are a hospitalist who is internal medicine trained, then you can teach FM or IM, whereas if you’re family medicine trained, you cannot teach internal medicine residents,” he said. “What happened with me, I had to prioritize recruiting internal medicine residents over FM residents to be able to staff IM teaching faculty.”
A rule change has been lobbied by SHM, under the direction of SHM family medicine SIG former chair David Goldstein, MD, to address this issue that would allow HTFMs with a FPHM designation to teach IM residents. The change was quietly made by the ACGME Review Committee for Internal Medicine in 2017, Dr. McCurry said, but implementation of the change has been slow.
“Essentially, the change was made in 2017 to allow for family medicine trainied physicians who have the FPHM designation to teach IM residents, but this knowledge has not been widely dispersed or policies updated to clearly reflect this change,” Dr. McCurry said. “It is a significant change, however, because prior to that, there were explicit policies preventing a family medicine hospitalist from teaching internal medicine residents even if they were experienced.”

FM physicians uniquely suited for HM

Requirements aside, it is “arguably not the case” that family medicine physicians need these extra certifications and fellowships to serve as hospitalists, Dr. McCurry said. It is difficult to quantify IM and FM hospitalist quality outcomes due to challenges with attribution, Dr. Odeti noted. One 2007 study published in the New England Journal of Medicine looked at patient quality and cost of care across the hospitalist model, and family medicine practitioners providing inpatients care. The investigators found similar outcomes in the internist model and with family practitioners providing inpatient care. Dr. Odeti said this research supports “the fact that family medicine physicians are equally competent as internists in providing inpatient care.”

HTFMs are growing within SHM

HTFMs are “all over,” being represented in smaller hospitals, larger hospitals, and university hospitals in every state. “But to reach those positions, they probably have to go over more hurdles and have fewer opportunities,” Dr. Chaudhry said.
There isn’t a completely accurate count of family medicine hospitalists in the United States. Out of an estimated 50,000 hospitalists in the U. S., about 16,000 hospitalists are members of SHM. A number of family medicine hospitalists may also take AAFP membership instead of SHM, Dr. Odeti explained.
However, there are a growing number of hospitalists within SHM with a family medicine background. In the 2007-2008 Society of Hospital Medicine Annual Survey, 3.7% of U.S. hospitalists claimed family medicine training. That number increased to 6.9% of physicians who answered the SHM membership data report in 2010.
A Medscape Hospitalist Lifestyle, Happiness & Burnout Report from 2019 estimates 17% of hospitalists are trained in family medicine. In the latest State of Hospital Medicine Report published in 2020, 38.6% of hospital medicine groups containing family medicine trained physicians were part of a university, medical school, or faculty practice; 79.6% did not have academic status; 83.8% were at a non-teaching hospital; 60.7% were in a group in a non-teaching service at a teaching hospital; and 52.8% were in a group at a combination teaching/non-teaching service at a teaching hospital.
Although the Report did not specify whether family medicine hospitalists were mainly in rural or urban areas, “some of us do practice in underserved area hospitals where you have the smaller ICU model, critical access hospitals, potentially dealing with a whole gamut of inpatient medicine from ER, to the hospital inpatient adult cases, to critical care level,” Dr. McCurry said. 
“But then, there are a large number of us who practice in private groups or at large hospitals, academic centers around the country,” she added. “There’s a range of family medicine trained hospitalist practice areas.”

Equal recognition for HTFM in HM

The SHM family medicine SIG has been working to highlight the issue of hiring practices for HTFMs, and is taking a number of actions to bring greater awareness and recognition to family medicine hospitalists.
The family medicine SIG is looking at steps for requesting a new joint statement from ABFM and SHM focused on hiring practices for family medicine physicians as hospitalists. “I think it’s worth considering now that we’re at a point where we comprise about one-fifth of hospitalists as family medicine docs,” Dr. McCurry said. “Is it time to take that joint statement to the next step, and seek a review of how we can improve the balance of hiring in terms of favoring more balanced consideration now that there are a lot more family medicine trained hospitalists than historically?
“I think the call is really to help us all move to that next step in terms of identifying any of the lingering vestiges of expectation that are really no longer applicable to the hiring practices, or shouldn’t be,” she said. 
The next step will be to ask hospitals with internal medicine only requirements for hospitalists to update their bylaws to include family medicine physicians when considering candidates for hospitalist positions. If SHM does not make a distinction to grant Fellow in Hospital Medicine status between internal medicine and family medicine trained hospitalists, “then there should not be any distinction, or there should not be any hindrance by the recruiters, by the bigger systems, as well as by the employers” in hiring a family medicine trained physician for a hospitalist position, Dr. Chaudhry said.
Dr. Odeti, who serves in several leadership roles within Ballad Health, describes the system as being friendly to HTFMs. About one-fourth of the hospitalists in Ballad Health are trained in family medicine. But when Dr. Odeti started his hospitalist practice, he was only one of a handful of HTFMs. He sees a future where the accomplishments and contributions of HTFMs will pave the way for future hospitalists. “Access into the urban hospitals is key, and I hope that SHM and the HTFM SIG will act as a catalyst for this change,” he said.
Colleagues of family medicine hospitalists, especially those in leadership positions at hospitals, can help by raising awareness, as can “those of our colleagues who sit on medical executive committees within their hospitals to review their bylaws, to see what the policies are, and encourage more competitiveness,” Dr. McCurry said. “Truly, the best candidate for the position, regardless of background and training, is what you want. You want the best colleagues for your fellow hospitalists. You want the best physician for your patients in the hospital.”
If training and all other things are equal, family medicine physicians should be evaluated on a case-by-case basis, she said. “I think that that puts the burden back on any good medical committee, and a good medical committee member who is an SHM member as well, to say, ‘If we are committed to quality patient care, we want to encourage the recruitment of all physicians that are truly the best physicians to reduce that distinction between FM and IM in order to allow those best candidates to present, whether they are FM or IM.’ That’s all that we’re asking.”
Dr. Chaudhry emphasized that the preference for internal medicine trained physicians isn’t intentional. “It’s not as if the systems are trying to do it,” he said. “I think it is more like everybody needs to be educated. And through the platform of the Society of Hospital Medicine, I think we can make a difference. It will be a slow change, but we’ll have to keep on working on it.”

Dr. Odeti, Dr. McCurry, and Dr. Chaudhry have no relevant financial disclosures.
 

For 2021, the American Diabetes Association offers new guidance on assessing patients’ financial and social barriers to care, especially given the COVID-19 pandemic, individualizing treatment of patients with type 2 diabetes, and use of diabetes technology.

As it does every year, the annual update incorporates new clinical information that has become available since the last guideline, with occasional revisions during the year as needed. “Standards of Medical Care in Diabetes – 2021,” was published online as a supplement to Diabetes Care.

The new standards advise that patients be assessed for food and housing insecurity, social support, and “cost-related medication nonadherence,” and those found to have difficulty referred to appropriate community resources.

“Clinicians need to be sensitive to the fact that patients may have very good reasons for not taking their medication, [as in] if they can’t afford it,” ADA chief science & medical officer Robert A. Gabbay, MD, PhD, said in an interview.

Dr. Gabbay noted that “a heightened awareness” of social determinants of health is weaved throughout the 2021 standards because of the pandemic, with information on the topic derived from a July 2020 joint consensus statement in Diabetes Care, endorsed by a number of other societies, as well as a November publication also in Diabetes Care.

“We made several recommendations that speak to social determinants of health, placing an emphasis on engaging in conversations around this subject and screening for related issues such as food insecurity that weren’t there previously,” he said.

“Screening tools are suggested. It helped us to have an in-depth scientific review of the literature to know the prevalence of this in people with diabetes. ... Having the science to put it in was a key step,” Dr. Gabbay noted.
 

Consider kidney, heart disease in type 2 treatment individualization

Recent data from trials such as CREDENCE and DAPA-HF, among others, have been added to inform the choice of pharmacologic treatment in patients with type 2 diabetes with comorbid diabetic kidney disease and chronic heart failure.

“ADA has been advocating individualization of treatment based on comorbidities for a while, but we’ve taken more steps in that direction. Beyond lifestyle for all individuals with type 2 diabetes, clinicians want to think early on about which comorbidities patients have and then think about the appropriate treatment based on that,” Dr. Gabbay said.

And for the third year in a row, the section on cardiovascular disease and risk management has been endorsed by the American College of Cardiology.

“All the things in that section are very much aligned with ACC and that’s been a great partnership,” Dr. Gabbay said.

Now, ADA is in discussions with other professional societies representing relevant specialties to create further such unified messages.

“What we all want to avoid is having multiple different guidelines. We want to speak with one voice and find common ground as much as possible. … It makes it much easier for clinicians to know what to do. That’s the goal of all this,” he noted.
 

Diabetes technology: The rise of CGM during pandemic and beyond

New information about continuous glucose monitoring (CGM) has been added to the diabetes technology section. Use of CGM is now recommended for anyone with diabetes who takes multiple daily injections or uses an insulin pump, regardless of age or diabetes type. The document provides expanded advice on use of time in range data for glycemic monitoring, particularly during the COVID-19 pandemic when remote monitoring is preferable.

Insurers are increasingly covering CGM for patients on insulin, but it’s far from universal. While the ultimate goal is to ensure access to CGM for everyone with diabetes, those treated with multiple daily insulin doses are the priority for now.

“Our hope is that as there’s greater evidence there will be more movement towards coverage. There are still so many people for whom it’s quite clear they would benefit because they’re on insulin but don’t have access to it. That’s an important area that ADA is advocating for, and it’s reflected in the standards of care,” Dr. Gabbay said.

In another technology-related revision, the term “blinded” CGM has been replaced with “professional CGM,” because clinic-based use of the devices can be “blinded” to the patient or monitored in real-time by both the patient and clinician. Also, a new recommendation has been added to address skin reactions associated with diabetes technology use.

Information about use of CGM in hospital settings during the COVID-19 pandemic has also been added in the technology section.

The COVID-19 pandemic comes up again in the section on vaccines.

“We mention that people with diabetes should be considered high priority [for COVID-19 vaccines], and that’s something that ADA is strongly advocating for because 40% of COVID-19 deaths have been in people with diabetes,” Dr. Gabbay said.

Dr. Gabbay reported being on the advisory boards of Onduo, Health Reveal, Vida Health, Lark, and Form Health.

A version of this article originally appeared on Medscape.com.

For 2021, the American Diabetes Association offers new guidance on assessing patients’ financial and social barriers to care, especially given the COVID-19 pandemic, individualizing treatment of patients with type 2 diabetes, and use of diabetes technology.

As it does every year, the annual update incorporates new clinical information that has become available since the last guideline, with occasional revisions during the year as needed. “Standards of Medical Care in Diabetes – 2021,” was published online as a supplement to Diabetes Care.

The new standards advise that patients be assessed for food and housing insecurity, social support, and “cost-related medication nonadherence,” and those found to have difficulty referred to appropriate community resources.

“Clinicians need to be sensitive to the fact that patients may have very good reasons for not taking their medication, [as in] if they can’t afford it,” ADA chief science & medical officer Robert A. Gabbay, MD, PhD, said in an interview.

Dr. Gabbay noted that “a heightened awareness” of social determinants of health is weaved throughout the 2021 standards because of the pandemic, with information on the topic derived from a July 2020 joint consensus statement in Diabetes Care, endorsed by a number of other societies, as well as a November publication also in Diabetes Care.

“We made several recommendations that speak to social determinants of health, placing an emphasis on engaging in conversations around this subject and screening for related issues such as food insecurity that weren’t there previously,” he said.

“Screening tools are suggested. It helped us to have an in-depth scientific review of the literature to know the prevalence of this in people with diabetes. ... Having the science to put it in was a key step,” Dr. Gabbay noted.
 

Consider kidney, heart disease in type 2 treatment individualization

Recent data from trials such as CREDENCE and DAPA-HF, among others, have been added to inform the choice of pharmacologic treatment in patients with type 2 diabetes with comorbid diabetic kidney disease and chronic heart failure.

“ADA has been advocating individualization of treatment based on comorbidities for a while, but we’ve taken more steps in that direction. Beyond lifestyle for all individuals with type 2 diabetes, clinicians want to think early on about which comorbidities patients have and then think about the appropriate treatment based on that,” Dr. Gabbay said.

And for the third year in a row, the section on cardiovascular disease and risk management has been endorsed by the American College of Cardiology.

“All the things in that section are very much aligned with ACC and that’s been a great partnership,” Dr. Gabbay said.

Now, ADA is in discussions with other professional societies representing relevant specialties to create further such unified messages.

“What we all want to avoid is having multiple different guidelines. We want to speak with one voice and find common ground as much as possible. … It makes it much easier for clinicians to know what to do. That’s the goal of all this,” he noted.
 

Diabetes technology: The rise of CGM during pandemic and beyond

New information about continuous glucose monitoring (CGM) has been added to the diabetes technology section. Use of CGM is now recommended for anyone with diabetes who takes multiple daily injections or uses an insulin pump, regardless of age or diabetes type. The document provides expanded advice on use of time in range data for glycemic monitoring, particularly during the COVID-19 pandemic when remote monitoring is preferable.

Insurers are increasingly covering CGM for patients on insulin, but it’s far from universal. While the ultimate goal is to ensure access to CGM for everyone with diabetes, those treated with multiple daily insulin doses are the priority for now.

“Our hope is that as there’s greater evidence there will be more movement towards coverage. There are still so many people for whom it’s quite clear they would benefit because they’re on insulin but don’t have access to it. That’s an important area that ADA is advocating for, and it’s reflected in the standards of care,” Dr. Gabbay said.

In another technology-related revision, the term “blinded” CGM has been replaced with “professional CGM,” because clinic-based use of the devices can be “blinded” to the patient or monitored in real-time by both the patient and clinician. Also, a new recommendation has been added to address skin reactions associated with diabetes technology use.

Information about use of CGM in hospital settings during the COVID-19 pandemic has also been added in the technology section.

The COVID-19 pandemic comes up again in the section on vaccines.

“We mention that people with diabetes should be considered high priority [for COVID-19 vaccines], and that’s something that ADA is strongly advocating for because 40% of COVID-19 deaths have been in people with diabetes,” Dr. Gabbay said.

Dr. Gabbay reported being on the advisory boards of Onduo, Health Reveal, Vida Health, Lark, and Form Health.

A version of this article originally appeared on Medscape.com.

For 2021, the American Diabetes Association offers new guidance on assessing patients’ financial and social barriers to care, especially given the COVID-19 pandemic, individualizing treatment of patients with type 2 diabetes, and use of diabetes technology.

As it does every year, the annual update incorporates new clinical information that has become available since the last guideline, with occasional revisions during the year as needed. “Standards of Medical Care in Diabetes – 2021,” was published online as a supplement to Diabetes Care.

The new standards advise that patients be assessed for food and housing insecurity, social support, and “cost-related medication nonadherence,” and those found to have difficulty referred to appropriate community resources.

“Clinicians need to be sensitive to the fact that patients may have very good reasons for not taking their medication, [as in] if they can’t afford it,” ADA chief science & medical officer Robert A. Gabbay, MD, PhD, said in an interview.

Dr. Gabbay noted that “a heightened awareness” of social determinants of health is weaved throughout the 2021 standards because of the pandemic, with information on the topic derived from a July 2020 joint consensus statement in Diabetes Care, endorsed by a number of other societies, as well as a November publication also in Diabetes Care.

“We made several recommendations that speak to social determinants of health, placing an emphasis on engaging in conversations around this subject and screening for related issues such as food insecurity that weren’t there previously,” he said.

“Screening tools are suggested. It helped us to have an in-depth scientific review of the literature to know the prevalence of this in people with diabetes. ... Having the science to put it in was a key step,” Dr. Gabbay noted.
 

Consider kidney, heart disease in type 2 treatment individualization

Recent data from trials such as CREDENCE and DAPA-HF, among others, have been added to inform the choice of pharmacologic treatment in patients with type 2 diabetes with comorbid diabetic kidney disease and chronic heart failure.

“ADA has been advocating individualization of treatment based on comorbidities for a while, but we’ve taken more steps in that direction. Beyond lifestyle for all individuals with type 2 diabetes, clinicians want to think early on about which comorbidities patients have and then think about the appropriate treatment based on that,” Dr. Gabbay said.

And for the third year in a row, the section on cardiovascular disease and risk management has been endorsed by the American College of Cardiology.

“All the things in that section are very much aligned with ACC and that’s been a great partnership,” Dr. Gabbay said.

Now, ADA is in discussions with other professional societies representing relevant specialties to create further such unified messages.

“What we all want to avoid is having multiple different guidelines. We want to speak with one voice and find common ground as much as possible. … It makes it much easier for clinicians to know what to do. That’s the goal of all this,” he noted.
 

Diabetes technology: The rise of CGM during pandemic and beyond

New information about continuous glucose monitoring (CGM) has been added to the diabetes technology section. Use of CGM is now recommended for anyone with diabetes who takes multiple daily injections or uses an insulin pump, regardless of age or diabetes type. The document provides expanded advice on use of time in range data for glycemic monitoring, particularly during the COVID-19 pandemic when remote monitoring is preferable.

Insurers are increasingly covering CGM for patients on insulin, but it’s far from universal. While the ultimate goal is to ensure access to CGM for everyone with diabetes, those treated with multiple daily insulin doses are the priority for now.

“Our hope is that as there’s greater evidence there will be more movement towards coverage. There are still so many people for whom it’s quite clear they would benefit because they’re on insulin but don’t have access to it. That’s an important area that ADA is advocating for, and it’s reflected in the standards of care,” Dr. Gabbay said.

In another technology-related revision, the term “blinded” CGM has been replaced with “professional CGM,” because clinic-based use of the devices can be “blinded” to the patient or monitored in real-time by both the patient and clinician. Also, a new recommendation has been added to address skin reactions associated with diabetes technology use.

Information about use of CGM in hospital settings during the COVID-19 pandemic has also been added in the technology section.

The COVID-19 pandemic comes up again in the section on vaccines.

“We mention that people with diabetes should be considered high priority [for COVID-19 vaccines], and that’s something that ADA is strongly advocating for because 40% of COVID-19 deaths have been in people with diabetes,” Dr. Gabbay said.

Dr. Gabbay reported being on the advisory boards of Onduo, Health Reveal, Vida Health, Lark, and Form Health.

A version of this article originally appeared on Medscape.com.

More than 40 value-based payment models – from direct contracting to bundled payments – have been introduced into the Medicare program in the past 10 years, with the goal of improving care while lowering costs. Hopes were high that they would be successful.

But despite the new alternative payment models, costs have not declined. If this continues, Medicare won’t have sufficient funds to cover benefit costs after 2024. Physicians could suffer a huge blow to their income.

Many of the value-based care models simply did not work as expected, said Seema Verma, head of the Centers for Medicare & Medicaid Services, at a recent HLTH Conference. “They are not producing the types of savings the taxpayers deserve,” Ms. Verma said.

The Medicare Payment Advisory Commission (MedPac) concluded that, while dozens of payment models were tested, most failed to generate net savings for Medicare. Even the most successful of the models produced only modest savings. MedPac elaborated: “The track record raises the question of whether changes to particular models or CMMI’s [Center for Medicare & Medicaid Innovation’s] broader strategies might be warranted.”

What will happen now, as government officials admit that their value-based programs haven’t worked? The value-based programs could become more stringent. Here’s what physicians will have to contend with.

More risk. Experts agree that risk – financial risk – will be a component of future programs. Two-sided risk is likely to be the norm. This means that both parties – the provider and the insurer – are at financial risk for the patients covered by the program.

For example, a plan with 50,000 beneficiary patients would estimate the cost of caring for those patients on the basis of multiple variables. If the actual cost is lower than anticipated, both parties share in the savings. However, both share in the loss if the cost of caring for their patient population exceeds expectations.

This may compel physicians to enhance efficiency and potentially limit the services provided to patients. Typically, however, the strategy is to make efforts to prevent services like ED visits and admissions by focusing on health maintenance.

In contrast to most current value-based models, which feature little to no downside risk for physicians, double-sided risk means physicians could lose money. The loss may incorporate a cap – 5%, for example – but programs may differ. Experts concur that double-sided risk will be a hallmark of future programs.

Better data. The majority of health care services are rendered via fee-for-service: Patients receive services and physicians are paid, yet little or no information about outcomes is exchanged between insurers and physicians.

Penny Noyes, president of Health Business Navigators and contract negotiator for physicians, is not a fan of the current crop of value-based programs and feels that data transparency is positive. Sound metrics can lead to improvement, she said, adding: “It’s not money that drives physicians to make decisions; it’s what’s in the best interest of their patients and their patients’ long-term care.”

Value-based programs can work but only if applicable data are developed and given to physicians so that they can better understand their current performance and how to improve.

Mandated participation. Participation in value-based programs has been voluntary, but that may have skewed the results, which were better than what typical practice would have shown. Acknowledging this may lead CMS to call for mandated participation as a component of future programs. Physicians may be brought into programs, if only to determine whether the models really work. To date, participation in the programs has been voluntary, but that may change in the future.

Innovation. The private insurance market may end up as a key player. Over the past 6 months, health insurers have either consolidated partnerships with telemedicine companies to provide no-cost care to beneficiaries or have launched their own initiatives.

Others are focused on bringing together patients and providers operating outside of the traditional health care system, such as Aetna’s merger with CVS which now offers retail-based acute care (MinuteClinic) and chronic care (HealthHUB). Still other payers are gambling with physician practice ownership, as in the case of United Healthcare’s OptumHealth, which now boasts around 50,000 physicians throughout the country.

New practice models are emerging in private practices as well. Physicians are embracing remote care, proactively managing care transitions, and seeking out more methods to keep patients healthy and at home.
 

Not much was expected from value-based plans 

Many are not surprised that the value-based models did not produce impressive results. Ms. Noyes doubted that positive outcomes will be achieved for physicians in comparison with what could have been attained under fee-for-service arrangements with lower administrative costs.

While the Affordable Care Act attempted to encourage alternative reimbursement, it limits the maximum medical loss ratio (MLR) a payer could achieve. For many plans, that maximum was 85%. Simply put, at least $0.85 of each premium collected had to be paid in claims; the remaining $0.15 went to margin, claims, and other administrative costs. A payer with an 82% MLR then would have to rebate the 3% difference to enrollees.

But that’s not what occurred, according to Ms. Noyes. Because value-based payments to providers are considered a claims expense, an MLR ratio of 82% allowed the payer to distribute the 3% difference to providers as value-based payments. Ms. Noyes said: “That may sound good for the provider, but the result was essentially a freeze on the provider’s fee-for-service reimbursement with the prospect of getting value-based payments like ‘shared savings.’ 

“When the providers tried to increase their base fee-for-service rates just to match inflation, payers often advised that any future raises had to be earned through value-based programs,” Ms. Noyes added. The value-based formulas confuse providers because payments are often made for periods as far back as 18 months, and providers do not have data systems to reconcile their payer report cards retrospectively. The result is that providers tended to accept whatever amount the payer distributed.

Executives at Lumeris, a company that helps health systems participate successfully in value-based care, see potential in a newer approach to alternative payments, such as CMS’ Direct Contracting initiative. This voluntary payment model offers options tailored to several types of organizations that aim to reduce costs while preserving or enhancing the quality of care for Medicare fee-for-service beneficiaries.

Jeff Smith, chief commercial officer for population health at Lumeris, explained that the Direct Contracting initiative can provide physicians with a more attractive option than prior value-based models because it adjusts for the complexity and fragility of patients with complex and chronic conditions. By allowing providers to participate in the savings generated, the initiative stands in stark contrast to what Mr. Smith described as the “shared savings to nothingness” experienced by providers in earlier-stage alternative payment models.

Physicians engaged with value-based programs like Direct Contracting are investing in nurses to aid with initiatives regarding health promotion and transitions of care. When a patient is discharged, for example, the nurse contacts the patient to discuss medications, schedule follow-up appointments, and so forth – tasks typically left to the patient (or caregiver) to navigate in the traditional system.

The initiative recognizes the importance of managing high-risk patients, those whom physicians identify as having an extraordinary number of ED visits and admissions. These patients, as well as so-called “rising-risk” patients, are targeted by nurses who proactively communicate with patients (and caregivers) to address patient’s needs, including social determinants of health.

Physicians who have a large load of patients in value-based programs are hiring social workers, pharmacists, and behavioral health experts to help. Of course, these personnel are costly, but that’s what the value-based programs aim to reimburse.

Still, the road ahead to value based is rocky and may not gain momentum for some time. Johns Hopkins University’s Doug Hough, PhD, an economist, recounts a government research study that sought to assess the university’s health system participation in a value-based payment program. While there were positive impacts on the program’s target population, Hough and his team discovered that the returns achieved by the optional model didn’t justify the health system’s financial support for it. The increasingly indebted health system ultimately decided to drop the optional program.

Dr. Hough indicated that the health system – Johns Hopkins Medicine – likely would have  continued its support for the program had the government at least allowed it to break even. Although the payment program under study was a 3-year project, the bigger challenge, declared Dr. Hough, is that “we can’t turn an aircraft carrier that quickly.”

“Three years won’t show whether value-based care is really working,” Dr. Hough said.

Robert Zipper, MD, a hospitalist and senior policy advisor for Sound Physicians, a company that works to improve outcomes in acute care, agreed with Dr. Hough that performance tends to improve with time. Yet, Dr. Zipper doesn’t see much change in the near term, because “after all, there is nothing to replace them [the programs].”

The problem gets even stickier for private payers because patients may be on an insurance panel for as little as a year or 2. Thanks to this rapid churn of beneficiaries, even the best-designed value-based program will have little time to prove its worth.

Dr. Zipper is among the many who don’t expect significant changes in the near term, asserting that “President Biden will want to get a few policy wins first, and health care is not the easiest place to start.”

But it’s likely that payers and others will want to see more emphasis on value-based programs despite these programs’ possible value to patients, physicians, and health systems alike.

A version of this article originally appeared on Medscape.com.

More than 40 value-based payment models – from direct contracting to bundled payments – have been introduced into the Medicare program in the past 10 years, with the goal of improving care while lowering costs. Hopes were high that they would be successful.

But despite the new alternative payment models, costs have not declined. If this continues, Medicare won’t have sufficient funds to cover benefit costs after 2024. Physicians could suffer a huge blow to their income.

Many of the value-based care models simply did not work as expected, said Seema Verma, head of the Centers for Medicare & Medicaid Services, at a recent HLTH Conference. “They are not producing the types of savings the taxpayers deserve,” Ms. Verma said.

The Medicare Payment Advisory Commission (MedPac) concluded that, while dozens of payment models were tested, most failed to generate net savings for Medicare. Even the most successful of the models produced only modest savings. MedPac elaborated: “The track record raises the question of whether changes to particular models or CMMI’s [Center for Medicare & Medicaid Innovation’s] broader strategies might be warranted.”

What will happen now, as government officials admit that their value-based programs haven’t worked? The value-based programs could become more stringent. Here’s what physicians will have to contend with.

More risk. Experts agree that risk – financial risk – will be a component of future programs. Two-sided risk is likely to be the norm. This means that both parties – the provider and the insurer – are at financial risk for the patients covered by the program.

For example, a plan with 50,000 beneficiary patients would estimate the cost of caring for those patients on the basis of multiple variables. If the actual cost is lower than anticipated, both parties share in the savings. However, both share in the loss if the cost of caring for their patient population exceeds expectations.

This may compel physicians to enhance efficiency and potentially limit the services provided to patients. Typically, however, the strategy is to make efforts to prevent services like ED visits and admissions by focusing on health maintenance.

In contrast to most current value-based models, which feature little to no downside risk for physicians, double-sided risk means physicians could lose money. The loss may incorporate a cap – 5%, for example – but programs may differ. Experts concur that double-sided risk will be a hallmark of future programs.

Better data. The majority of health care services are rendered via fee-for-service: Patients receive services and physicians are paid, yet little or no information about outcomes is exchanged between insurers and physicians.

Penny Noyes, president of Health Business Navigators and contract negotiator for physicians, is not a fan of the current crop of value-based programs and feels that data transparency is positive. Sound metrics can lead to improvement, she said, adding: “It’s not money that drives physicians to make decisions; it’s what’s in the best interest of their patients and their patients’ long-term care.”

Value-based programs can work but only if applicable data are developed and given to physicians so that they can better understand their current performance and how to improve.

Mandated participation. Participation in value-based programs has been voluntary, but that may have skewed the results, which were better than what typical practice would have shown. Acknowledging this may lead CMS to call for mandated participation as a component of future programs. Physicians may be brought into programs, if only to determine whether the models really work. To date, participation in the programs has been voluntary, but that may change in the future.

Innovation. The private insurance market may end up as a key player. Over the past 6 months, health insurers have either consolidated partnerships with telemedicine companies to provide no-cost care to beneficiaries or have launched their own initiatives.

Others are focused on bringing together patients and providers operating outside of the traditional health care system, such as Aetna’s merger with CVS which now offers retail-based acute care (MinuteClinic) and chronic care (HealthHUB). Still other payers are gambling with physician practice ownership, as in the case of United Healthcare’s OptumHealth, which now boasts around 50,000 physicians throughout the country.

New practice models are emerging in private practices as well. Physicians are embracing remote care, proactively managing care transitions, and seeking out more methods to keep patients healthy and at home.
 

Not much was expected from value-based plans 

Many are not surprised that the value-based models did not produce impressive results. Ms. Noyes doubted that positive outcomes will be achieved for physicians in comparison with what could have been attained under fee-for-service arrangements with lower administrative costs.

While the Affordable Care Act attempted to encourage alternative reimbursement, it limits the maximum medical loss ratio (MLR) a payer could achieve. For many plans, that maximum was 85%. Simply put, at least $0.85 of each premium collected had to be paid in claims; the remaining $0.15 went to margin, claims, and other administrative costs. A payer with an 82% MLR then would have to rebate the 3% difference to enrollees.

But that’s not what occurred, according to Ms. Noyes. Because value-based payments to providers are considered a claims expense, an MLR ratio of 82% allowed the payer to distribute the 3% difference to providers as value-based payments. Ms. Noyes said: “That may sound good for the provider, but the result was essentially a freeze on the provider’s fee-for-service reimbursement with the prospect of getting value-based payments like ‘shared savings.’ 

“When the providers tried to increase their base fee-for-service rates just to match inflation, payers often advised that any future raises had to be earned through value-based programs,” Ms. Noyes added. The value-based formulas confuse providers because payments are often made for periods as far back as 18 months, and providers do not have data systems to reconcile their payer report cards retrospectively. The result is that providers tended to accept whatever amount the payer distributed.

Executives at Lumeris, a company that helps health systems participate successfully in value-based care, see potential in a newer approach to alternative payments, such as CMS’ Direct Contracting initiative. This voluntary payment model offers options tailored to several types of organizations that aim to reduce costs while preserving or enhancing the quality of care for Medicare fee-for-service beneficiaries.

Jeff Smith, chief commercial officer for population health at Lumeris, explained that the Direct Contracting initiative can provide physicians with a more attractive option than prior value-based models because it adjusts for the complexity and fragility of patients with complex and chronic conditions. By allowing providers to participate in the savings generated, the initiative stands in stark contrast to what Mr. Smith described as the “shared savings to nothingness” experienced by providers in earlier-stage alternative payment models.

Physicians engaged with value-based programs like Direct Contracting are investing in nurses to aid with initiatives regarding health promotion and transitions of care. When a patient is discharged, for example, the nurse contacts the patient to discuss medications, schedule follow-up appointments, and so forth – tasks typically left to the patient (or caregiver) to navigate in the traditional system.

The initiative recognizes the importance of managing high-risk patients, those whom physicians identify as having an extraordinary number of ED visits and admissions. These patients, as well as so-called “rising-risk” patients, are targeted by nurses who proactively communicate with patients (and caregivers) to address patient’s needs, including social determinants of health.

Physicians who have a large load of patients in value-based programs are hiring social workers, pharmacists, and behavioral health experts to help. Of course, these personnel are costly, but that’s what the value-based programs aim to reimburse.

Still, the road ahead to value based is rocky and may not gain momentum for some time. Johns Hopkins University’s Doug Hough, PhD, an economist, recounts a government research study that sought to assess the university’s health system participation in a value-based payment program. While there were positive impacts on the program’s target population, Hough and his team discovered that the returns achieved by the optional model didn’t justify the health system’s financial support for it. The increasingly indebted health system ultimately decided to drop the optional program.

Dr. Hough indicated that the health system – Johns Hopkins Medicine – likely would have  continued its support for the program had the government at least allowed it to break even. Although the payment program under study was a 3-year project, the bigger challenge, declared Dr. Hough, is that “we can’t turn an aircraft carrier that quickly.”

“Three years won’t show whether value-based care is really working,” Dr. Hough said.

Robert Zipper, MD, a hospitalist and senior policy advisor for Sound Physicians, a company that works to improve outcomes in acute care, agreed with Dr. Hough that performance tends to improve with time. Yet, Dr. Zipper doesn’t see much change in the near term, because “after all, there is nothing to replace them [the programs].”

The problem gets even stickier for private payers because patients may be on an insurance panel for as little as a year or 2. Thanks to this rapid churn of beneficiaries, even the best-designed value-based program will have little time to prove its worth.

Dr. Zipper is among the many who don’t expect significant changes in the near term, asserting that “President Biden will want to get a few policy wins first, and health care is not the easiest place to start.”

But it’s likely that payers and others will want to see more emphasis on value-based programs despite these programs’ possible value to patients, physicians, and health systems alike.

A version of this article originally appeared on Medscape.com.

More than 40 value-based payment models – from direct contracting to bundled payments – have been introduced into the Medicare program in the past 10 years, with the goal of improving care while lowering costs. Hopes were high that they would be successful.

But despite the new alternative payment models, costs have not declined. If this continues, Medicare won’t have sufficient funds to cover benefit costs after 2024. Physicians could suffer a huge blow to their income.

Many of the value-based care models simply did not work as expected, said Seema Verma, head of the Centers for Medicare & Medicaid Services, at a recent HLTH Conference. “They are not producing the types of savings the taxpayers deserve,” Ms. Verma said.

The Medicare Payment Advisory Commission (MedPac) concluded that, while dozens of payment models were tested, most failed to generate net savings for Medicare. Even the most successful of the models produced only modest savings. MedPac elaborated: “The track record raises the question of whether changes to particular models or CMMI’s [Center for Medicare & Medicaid Innovation’s] broader strategies might be warranted.”

What will happen now, as government officials admit that their value-based programs haven’t worked? The value-based programs could become more stringent. Here’s what physicians will have to contend with.

More risk. Experts agree that risk – financial risk – will be a component of future programs. Two-sided risk is likely to be the norm. This means that both parties – the provider and the insurer – are at financial risk for the patients covered by the program.

For example, a plan with 50,000 beneficiary patients would estimate the cost of caring for those patients on the basis of multiple variables. If the actual cost is lower than anticipated, both parties share in the savings. However, both share in the loss if the cost of caring for their patient population exceeds expectations.

This may compel physicians to enhance efficiency and potentially limit the services provided to patients. Typically, however, the strategy is to make efforts to prevent services like ED visits and admissions by focusing on health maintenance.

In contrast to most current value-based models, which feature little to no downside risk for physicians, double-sided risk means physicians could lose money. The loss may incorporate a cap – 5%, for example – but programs may differ. Experts concur that double-sided risk will be a hallmark of future programs.

Better data. The majority of health care services are rendered via fee-for-service: Patients receive services and physicians are paid, yet little or no information about outcomes is exchanged between insurers and physicians.

Penny Noyes, president of Health Business Navigators and contract negotiator for physicians, is not a fan of the current crop of value-based programs and feels that data transparency is positive. Sound metrics can lead to improvement, she said, adding: “It’s not money that drives physicians to make decisions; it’s what’s in the best interest of their patients and their patients’ long-term care.”

Value-based programs can work but only if applicable data are developed and given to physicians so that they can better understand their current performance and how to improve.

Mandated participation. Participation in value-based programs has been voluntary, but that may have skewed the results, which were better than what typical practice would have shown. Acknowledging this may lead CMS to call for mandated participation as a component of future programs. Physicians may be brought into programs, if only to determine whether the models really work. To date, participation in the programs has been voluntary, but that may change in the future.

Innovation. The private insurance market may end up as a key player. Over the past 6 months, health insurers have either consolidated partnerships with telemedicine companies to provide no-cost care to beneficiaries or have launched their own initiatives.

Others are focused on bringing together patients and providers operating outside of the traditional health care system, such as Aetna’s merger with CVS which now offers retail-based acute care (MinuteClinic) and chronic care (HealthHUB). Still other payers are gambling with physician practice ownership, as in the case of United Healthcare’s OptumHealth, which now boasts around 50,000 physicians throughout the country.

New practice models are emerging in private practices as well. Physicians are embracing remote care, proactively managing care transitions, and seeking out more methods to keep patients healthy and at home.
 

Not much was expected from value-based plans 

Many are not surprised that the value-based models did not produce impressive results. Ms. Noyes doubted that positive outcomes will be achieved for physicians in comparison with what could have been attained under fee-for-service arrangements with lower administrative costs.

While the Affordable Care Act attempted to encourage alternative reimbursement, it limits the maximum medical loss ratio (MLR) a payer could achieve. For many plans, that maximum was 85%. Simply put, at least $0.85 of each premium collected had to be paid in claims; the remaining $0.15 went to margin, claims, and other administrative costs. A payer with an 82% MLR then would have to rebate the 3% difference to enrollees.

But that’s not what occurred, according to Ms. Noyes. Because value-based payments to providers are considered a claims expense, an MLR ratio of 82% allowed the payer to distribute the 3% difference to providers as value-based payments. Ms. Noyes said: “That may sound good for the provider, but the result was essentially a freeze on the provider’s fee-for-service reimbursement with the prospect of getting value-based payments like ‘shared savings.’ 

“When the providers tried to increase their base fee-for-service rates just to match inflation, payers often advised that any future raises had to be earned through value-based programs,” Ms. Noyes added. The value-based formulas confuse providers because payments are often made for periods as far back as 18 months, and providers do not have data systems to reconcile their payer report cards retrospectively. The result is that providers tended to accept whatever amount the payer distributed.

Executives at Lumeris, a company that helps health systems participate successfully in value-based care, see potential in a newer approach to alternative payments, such as CMS’ Direct Contracting initiative. This voluntary payment model offers options tailored to several types of organizations that aim to reduce costs while preserving or enhancing the quality of care for Medicare fee-for-service beneficiaries.

Jeff Smith, chief commercial officer for population health at Lumeris, explained that the Direct Contracting initiative can provide physicians with a more attractive option than prior value-based models because it adjusts for the complexity and fragility of patients with complex and chronic conditions. By allowing providers to participate in the savings generated, the initiative stands in stark contrast to what Mr. Smith described as the “shared savings to nothingness” experienced by providers in earlier-stage alternative payment models.

Physicians engaged with value-based programs like Direct Contracting are investing in nurses to aid with initiatives regarding health promotion and transitions of care. When a patient is discharged, for example, the nurse contacts the patient to discuss medications, schedule follow-up appointments, and so forth – tasks typically left to the patient (or caregiver) to navigate in the traditional system.

The initiative recognizes the importance of managing high-risk patients, those whom physicians identify as having an extraordinary number of ED visits and admissions. These patients, as well as so-called “rising-risk” patients, are targeted by nurses who proactively communicate with patients (and caregivers) to address patient’s needs, including social determinants of health.

Physicians who have a large load of patients in value-based programs are hiring social workers, pharmacists, and behavioral health experts to help. Of course, these personnel are costly, but that’s what the value-based programs aim to reimburse.

Still, the road ahead to value based is rocky and may not gain momentum for some time. Johns Hopkins University’s Doug Hough, PhD, an economist, recounts a government research study that sought to assess the university’s health system participation in a value-based payment program. While there were positive impacts on the program’s target population, Hough and his team discovered that the returns achieved by the optional model didn’t justify the health system’s financial support for it. The increasingly indebted health system ultimately decided to drop the optional program.

Dr. Hough indicated that the health system – Johns Hopkins Medicine – likely would have  continued its support for the program had the government at least allowed it to break even. Although the payment program under study was a 3-year project, the bigger challenge, declared Dr. Hough, is that “we can’t turn an aircraft carrier that quickly.”

“Three years won’t show whether value-based care is really working,” Dr. Hough said.

Robert Zipper, MD, a hospitalist and senior policy advisor for Sound Physicians, a company that works to improve outcomes in acute care, agreed with Dr. Hough that performance tends to improve with time. Yet, Dr. Zipper doesn’t see much change in the near term, because “after all, there is nothing to replace them [the programs].”

The problem gets even stickier for private payers because patients may be on an insurance panel for as little as a year or 2. Thanks to this rapid churn of beneficiaries, even the best-designed value-based program will have little time to prove its worth.

Dr. Zipper is among the many who don’t expect significant changes in the near term, asserting that “President Biden will want to get a few policy wins first, and health care is not the easiest place to start.”

But it’s likely that payers and others will want to see more emphasis on value-based programs despite these programs’ possible value to patients, physicians, and health systems alike.

A version of this article originally appeared on Medscape.com.

In 2014, I began taking care of a patient (see photo) who had developed over 25 basal cell carcinomas on her lower legs, which were surgically removed. Given the results of a 2015 study by Chen et al. on the protective effects of nicotinamide in the prevention of nonmelanoma skin cancers, I began her on oral nicotinamide, 500 mg twice daily. She has been clear of any skin cancers in the last 2 years since starting supplementation.

Lily Talakoub, MD

Nicotinamide, also known as niacinamide, is a water soluble form of vitamin B3 that has been shown to enhance the repair of UV-induced DNA damage. Nicotinamide is found naturally in meat, fish, nuts, grains, and legumes, and is a key component of the glycolysis pathway, by generating nicotinamide adenine dinucleotide for adenosine triphosphate production. Nicotinamide deficiency causes photosensitive dermatitis, diarrhea, and dementia. It has been studied for its anti-inflammatory benefits as an adjunct treatment for rosacea, bullous diseases, acne, and melasma.

Nonmelanoma skin cancers are known to be caused primarily by UV radiation. The supplementation of nicotinamide orally twice daily has been shown to reduce the rate of actinic keratoses and new nonmelanoma skin cancers compared with placebo after 1 year in patients who previously had skin cancer. In the phase 3 study published in 2015, a randomized, controlled trial of 386 patients who had at least two nonmelanoma skin cancers within the previous 5-year period, oral nicotinamide 500 mg given twice daily for a 12-month period significantly reduced the number of new nonmelanoma skin cancers by 23% versus those on placebo.

The recommended dose for nicotinamide, which is available over the counter as Vitamin B3, is 500 mg twice a day. Nicotinamide should not be confused with niacin (nicotinic acid), which has been used to treat high cholesterol and cardiovascular disease. There are no significant side effects from long-term use; however nicotinamide should not be used in patients with end-stage kidney disease or chronic kidney disease. (Niacin, however, can cause elevation of liver enzymes, headache, flushing, and increased blood pressure.) Nicotinamide crosses the placenta and should not be used in pregnancy as it has not been studied in pregnant populations.

We should counsel patients that this is not an oral sunscreen, and that sun avoidance, sunscreen, and yearly skin cancer checks are still the mainstay of skin cancer prevention. However, given the safety profile of nicotinamide and the protective effects, should all of our skin cancer patients be taking nicotinamide daily? In my practice they are, all of whom swear by it and have had significant reductions of both actinic keratoses and nonmelanoma skin cancers.

Dr. Talakoub and Dr. Wesley are cocontributors to this column. Dr. Talakoub is in private practice in McLean, Va. Dr. Wesley practices dermatology in Beverly Hills, Calif. This month’s column is by Dr. Talakoub. Write to them at [email protected]. They had no relevant disclosures.

In 2014, I began taking care of a patient (see photo) who had developed over 25 basal cell carcinomas on her lower legs, which were surgically removed. Given the results of a 2015 study by Chen et al. on the protective effects of nicotinamide in the prevention of nonmelanoma skin cancers, I began her on oral nicotinamide, 500 mg twice daily. She has been clear of any skin cancers in the last 2 years since starting supplementation.

Lily Talakoub, MD

Nicotinamide, also known as niacinamide, is a water soluble form of vitamin B3 that has been shown to enhance the repair of UV-induced DNA damage. Nicotinamide is found naturally in meat, fish, nuts, grains, and legumes, and is a key component of the glycolysis pathway, by generating nicotinamide adenine dinucleotide for adenosine triphosphate production. Nicotinamide deficiency causes photosensitive dermatitis, diarrhea, and dementia. It has been studied for its anti-inflammatory benefits as an adjunct treatment for rosacea, bullous diseases, acne, and melasma.

Nonmelanoma skin cancers are known to be caused primarily by UV radiation. The supplementation of nicotinamide orally twice daily has been shown to reduce the rate of actinic keratoses and new nonmelanoma skin cancers compared with placebo after 1 year in patients who previously had skin cancer. In the phase 3 study published in 2015, a randomized, controlled trial of 386 patients who had at least two nonmelanoma skin cancers within the previous 5-year period, oral nicotinamide 500 mg given twice daily for a 12-month period significantly reduced the number of new nonmelanoma skin cancers by 23% versus those on placebo.

The recommended dose for nicotinamide, which is available over the counter as Vitamin B3, is 500 mg twice a day. Nicotinamide should not be confused with niacin (nicotinic acid), which has been used to treat high cholesterol and cardiovascular disease. There are no significant side effects from long-term use; however nicotinamide should not be used in patients with end-stage kidney disease or chronic kidney disease. (Niacin, however, can cause elevation of liver enzymes, headache, flushing, and increased blood pressure.) Nicotinamide crosses the placenta and should not be used in pregnancy as it has not been studied in pregnant populations.

We should counsel patients that this is not an oral sunscreen, and that sun avoidance, sunscreen, and yearly skin cancer checks are still the mainstay of skin cancer prevention. However, given the safety profile of nicotinamide and the protective effects, should all of our skin cancer patients be taking nicotinamide daily? In my practice they are, all of whom swear by it and have had significant reductions of both actinic keratoses and nonmelanoma skin cancers.

Dr. Talakoub and Dr. Wesley are cocontributors to this column. Dr. Talakoub is in private practice in McLean, Va. Dr. Wesley practices dermatology in Beverly Hills, Calif. This month’s column is by Dr. Talakoub. Write to them at [email protected]. They had no relevant disclosures.

In 2014, I began taking care of a patient (see photo) who had developed over 25 basal cell carcinomas on her lower legs, which were surgically removed. Given the results of a 2015 study by Chen et al. on the protective effects of nicotinamide in the prevention of nonmelanoma skin cancers, I began her on oral nicotinamide, 500 mg twice daily. She has been clear of any skin cancers in the last 2 years since starting supplementation.

Lily Talakoub, MD

Nicotinamide, also known as niacinamide, is a water soluble form of vitamin B3 that has been shown to enhance the repair of UV-induced DNA damage. Nicotinamide is found naturally in meat, fish, nuts, grains, and legumes, and is a key component of the glycolysis pathway, by generating nicotinamide adenine dinucleotide for adenosine triphosphate production. Nicotinamide deficiency causes photosensitive dermatitis, diarrhea, and dementia. It has been studied for its anti-inflammatory benefits as an adjunct treatment for rosacea, bullous diseases, acne, and melasma.

Nonmelanoma skin cancers are known to be caused primarily by UV radiation. The supplementation of nicotinamide orally twice daily has been shown to reduce the rate of actinic keratoses and new nonmelanoma skin cancers compared with placebo after 1 year in patients who previously had skin cancer. In the phase 3 study published in 2015, a randomized, controlled trial of 386 patients who had at least two nonmelanoma skin cancers within the previous 5-year period, oral nicotinamide 500 mg given twice daily for a 12-month period significantly reduced the number of new nonmelanoma skin cancers by 23% versus those on placebo.

The recommended dose for nicotinamide, which is available over the counter as Vitamin B3, is 500 mg twice a day. Nicotinamide should not be confused with niacin (nicotinic acid), which has been used to treat high cholesterol and cardiovascular disease. There are no significant side effects from long-term use; however nicotinamide should not be used in patients with end-stage kidney disease or chronic kidney disease. (Niacin, however, can cause elevation of liver enzymes, headache, flushing, and increased blood pressure.) Nicotinamide crosses the placenta and should not be used in pregnancy as it has not been studied in pregnant populations.

We should counsel patients that this is not an oral sunscreen, and that sun avoidance, sunscreen, and yearly skin cancer checks are still the mainstay of skin cancer prevention. However, given the safety profile of nicotinamide and the protective effects, should all of our skin cancer patients be taking nicotinamide daily? In my practice they are, all of whom swear by it and have had significant reductions of both actinic keratoses and nonmelanoma skin cancers.

Dr. Talakoub and Dr. Wesley are cocontributors to this column. Dr. Talakoub is in private practice in McLean, Va. Dr. Wesley practices dermatology in Beverly Hills, Calif. This month’s column is by Dr. Talakoub. Write to them at [email protected]. They had no relevant disclosures.

As the COVID-19 vaccine candidates have begun to roll off the production lines into the distribution networks by the millions, media coverage almost universally includes a still photo or video of someone receiving an injection. Ever observant, a retired lawyer friend of mine who learned to give shots when he was in the Army and again more recently while taking a wilderness survival course emailed me his concerns about what he felt were examples of poor injection technique. Included in his commentary was an Internet link in which a physician, who I suspect may have been a pediatrician, demonstrated what the physician considered proper intramuscular injection technique, which included a single-handed aspiration prior to giving the injection allowing the free hand to stabilize the patient’s – in this case a child’s – arm during the entire process.

Sean Locke/iStockphoto

I replied to my friend that I too was often troubled by what I considered to be poor injection technique. But, I said the physician in the link touting his improved technique was misguided. My understanding has been that unless the injection site is in the gluteus, there is no need aspirate prior to an intramuscular vaccine injection because the risk of intravascular injection is so small. I then confirmed this by reviewing the Centers for Disease Control and Prevention’s Vaccine Recommendations and Guidelines of the Advisory Committee on Immunization Practices, which was updated in June 2019. Included in those recommendations was the observation that the vaccine administrator does not need to wear gloves unless he or she has open lesions or is at risk from contacting the recipient’s body fluids.

My little research project into proper injection technique got me thinking about how and when I learned to give shots. Like many of the technical skills one learns in training, giving intramuscular injections is probably an example of the “see one, do one, teach one” mantra. But in the case of giving shots, I don’t recall any teaching. Do you? It was more “see a dozen and get on with it.” Or maybe you trained in an environment in which nurses gave all the injections. I hope not.

When it comes to giving immunizations to children, the art is in entering into that encounter with a calm, matter-of-fact attitude and body language, hiding the needle, firmly restraining the child, and moving quickly and smoothly. Aspirating and glove donning merely add to the drama and waste time. But how did I learn that art? No one taught me. Like many clinical skills, I watched scores of nurses and physicians, mentally logging in their tricks and mistakes that would help me craft my style.

I always felt and still feel that providing immunizations was per hour spent, the most valuable investment of my time. Doing the injecting myself was both the most efficient way to provide the service, and also emphasized the importance that I placed on the immunization. In the process of my 40-plus–year career, that included several hundred thousand patient encounters in which I gave innumerable injections. And, I egotistically assumed that I was good at it because many infants never cried, and a few children said, “That didn’t hurt.” I suspect you can make the same claim.

Injecting millions of adults with a COVID-19 vaccine, on the other hand, is a piece of cake because restraining the recipient shouldn’t factor into the scenario. However, I wonder who is going to administer all those millions of injections and who is going to train them? How many of the trainers are aware of the CDC-ACIP guidelines? Or, are they going to fall back on old techniques that lack evidence support?

From the efficiency standpoint, it probably doesn’t make much difference. The injection takes but a few seconds. Filling out the paperwork and waiting for the recipient to figure out how to expose his or her deltoid can take fifty times that long.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

As the COVID-19 vaccine candidates have begun to roll off the production lines into the distribution networks by the millions, media coverage almost universally includes a still photo or video of someone receiving an injection. Ever observant, a retired lawyer friend of mine who learned to give shots when he was in the Army and again more recently while taking a wilderness survival course emailed me his concerns about what he felt were examples of poor injection technique. Included in his commentary was an Internet link in which a physician, who I suspect may have been a pediatrician, demonstrated what the physician considered proper intramuscular injection technique, which included a single-handed aspiration prior to giving the injection allowing the free hand to stabilize the patient’s – in this case a child’s – arm during the entire process.

Sean Locke/iStockphoto

I replied to my friend that I too was often troubled by what I considered to be poor injection technique. But, I said the physician in the link touting his improved technique was misguided. My understanding has been that unless the injection site is in the gluteus, there is no need aspirate prior to an intramuscular vaccine injection because the risk of intravascular injection is so small. I then confirmed this by reviewing the Centers for Disease Control and Prevention’s Vaccine Recommendations and Guidelines of the Advisory Committee on Immunization Practices, which was updated in June 2019. Included in those recommendations was the observation that the vaccine administrator does not need to wear gloves unless he or she has open lesions or is at risk from contacting the recipient’s body fluids.

My little research project into proper injection technique got me thinking about how and when I learned to give shots. Like many of the technical skills one learns in training, giving intramuscular injections is probably an example of the “see one, do one, teach one” mantra. But in the case of giving shots, I don’t recall any teaching. Do you? It was more “see a dozen and get on with it.” Or maybe you trained in an environment in which nurses gave all the injections. I hope not.

When it comes to giving immunizations to children, the art is in entering into that encounter with a calm, matter-of-fact attitude and body language, hiding the needle, firmly restraining the child, and moving quickly and smoothly. Aspirating and glove donning merely add to the drama and waste time. But how did I learn that art? No one taught me. Like many clinical skills, I watched scores of nurses and physicians, mentally logging in their tricks and mistakes that would help me craft my style.

I always felt and still feel that providing immunizations was per hour spent, the most valuable investment of my time. Doing the injecting myself was both the most efficient way to provide the service, and also emphasized the importance that I placed on the immunization. In the process of my 40-plus–year career, that included several hundred thousand patient encounters in which I gave innumerable injections. And, I egotistically assumed that I was good at it because many infants never cried, and a few children said, “That didn’t hurt.” I suspect you can make the same claim.

Injecting millions of adults with a COVID-19 vaccine, on the other hand, is a piece of cake because restraining the recipient shouldn’t factor into the scenario. However, I wonder who is going to administer all those millions of injections and who is going to train them? How many of the trainers are aware of the CDC-ACIP guidelines? Or, are they going to fall back on old techniques that lack evidence support?

From the efficiency standpoint, it probably doesn’t make much difference. The injection takes but a few seconds. Filling out the paperwork and waiting for the recipient to figure out how to expose his or her deltoid can take fifty times that long.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

As the COVID-19 vaccine candidates have begun to roll off the production lines into the distribution networks by the millions, media coverage almost universally includes a still photo or video of someone receiving an injection. Ever observant, a retired lawyer friend of mine who learned to give shots when he was in the Army and again more recently while taking a wilderness survival course emailed me his concerns about what he felt were examples of poor injection technique. Included in his commentary was an Internet link in which a physician, who I suspect may have been a pediatrician, demonstrated what the physician considered proper intramuscular injection technique, which included a single-handed aspiration prior to giving the injection allowing the free hand to stabilize the patient’s – in this case a child’s – arm during the entire process.

Sean Locke/iStockphoto

I replied to my friend that I too was often troubled by what I considered to be poor injection technique. But, I said the physician in the link touting his improved technique was misguided. My understanding has been that unless the injection site is in the gluteus, there is no need aspirate prior to an intramuscular vaccine injection because the risk of intravascular injection is so small. I then confirmed this by reviewing the Centers for Disease Control and Prevention’s Vaccine Recommendations and Guidelines of the Advisory Committee on Immunization Practices, which was updated in June 2019. Included in those recommendations was the observation that the vaccine administrator does not need to wear gloves unless he or she has open lesions or is at risk from contacting the recipient’s body fluids.

My little research project into proper injection technique got me thinking about how and when I learned to give shots. Like many of the technical skills one learns in training, giving intramuscular injections is probably an example of the “see one, do one, teach one” mantra. But in the case of giving shots, I don’t recall any teaching. Do you? It was more “see a dozen and get on with it.” Or maybe you trained in an environment in which nurses gave all the injections. I hope not.

When it comes to giving immunizations to children, the art is in entering into that encounter with a calm, matter-of-fact attitude and body language, hiding the needle, firmly restraining the child, and moving quickly and smoothly. Aspirating and glove donning merely add to the drama and waste time. But how did I learn that art? No one taught me. Like many clinical skills, I watched scores of nurses and physicians, mentally logging in their tricks and mistakes that would help me craft my style.

I always felt and still feel that providing immunizations was per hour spent, the most valuable investment of my time. Doing the injecting myself was both the most efficient way to provide the service, and also emphasized the importance that I placed on the immunization. In the process of my 40-plus–year career, that included several hundred thousand patient encounters in which I gave innumerable injections. And, I egotistically assumed that I was good at it because many infants never cried, and a few children said, “That didn’t hurt.” I suspect you can make the same claim.

Injecting millions of adults with a COVID-19 vaccine, on the other hand, is a piece of cake because restraining the recipient shouldn’t factor into the scenario. However, I wonder who is going to administer all those millions of injections and who is going to train them? How many of the trainers are aware of the CDC-ACIP guidelines? Or, are they going to fall back on old techniques that lack evidence support?

From the efficiency standpoint, it probably doesn’t make much difference. The injection takes but a few seconds. Filling out the paperwork and waiting for the recipient to figure out how to expose his or her deltoid can take fifty times that long.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

The antibody–drug conjugate sacituzumab govitecan (SG) appears to be effective across biomarker subgroups for women with metastatic triple-negative breast cancer (mTNBC) that has progressed after multiple lines of therapy, a biomarker evaluation from the phase 3 ASCENT trial shows.

But both an observer and the lead study author cautioned that the results were hypothesis generating.

Nonetheless, the data suggest the drug yields good survival outcomes in comparison with placebo in both BRCA1/2-positive and -negative patients and is effective even for those with low expression of the target protein, trophoblast cell surface antigen 2 (Trop-2).

The research was presented at the San Antonio Breast Cancer Symposium (SABCS) 2020.

Study presenter Sara Hurvitz, MD, Jonsson Comprehensive Cancer Center, University of California, Los Angeles, urged caution in interpreting the data, given the small sample sizes in the Trop-2–low subgroup and germline BRCA1/2-positive subgroup.

Jennifer K. Litton, MD, University of Texas MD Anderson Cancer Center, Houston, Texas, who was not involved in the research, echoed those comments.

She told Medscape Medical News that the numbers, particularly for the BRCA1/2 analysis, were “very small.”

She added: “This was not a prespecified group, so it represents an interesting analysis to be hypothesis generating for future studies but not anything applicable to current clinical practice.”

Nevertheless, Litton said the data from the primary analysis of ASCENT remain “practice changing” for women with mTNBC who have received at least two previous lines of therapy.

As to whether SG will eventually move beyond this advanced setting, she emphasized that “more trials would need to be done and reported evaluating its role in other settings, and hopefully expanding its usefulness for patients.”

SG is a first-in-class drug comprising an antibody directed at Trop-2, which is highly expressed in breast cancer, and linked to SN-38, the active metabolite of irinotecan.

On the basis of positive phase 1/2 trial data, SG was granted accelerated approval by the US Food and Drug Administration for patients with mTNBC who experience disease progression after at least two prior therapies.

As reported by Medscape Medical News, primary results from ASCENT that were presented at ESMO 2020 showed that SG improved progression-free survival (PFS) by nearly 4 months and overall survival by more than 5 months for women with pretreated mTNBC compared to chemotherapy.
 

Study details

At SABCS, Hurvitz presented an exploratory biomarker evaluation of data from the trial regarding the association between SG efficacy and Trop-2 expression, as well as germline BRCA1/2 mutation status.

She reminded the audience that, in ASCENT, 529 patients with mTNBC who had experienced disease progression after undergoing at least two chemotherapy regimens for advanced disease were randomly assigned in a 1:1 ratio to receive intravenous SG on days 1 and 8 of a 21-day cycle or physician’s choice of treatment.

Treatment was continued until disease progression or unacceptable toxicity occurred.

For the current analysis, which focused on patients who did not have brain metastases, the team studied primary or metastatic archival biopsy or surgical specimens collected at study entry.

These were analyzed using a validated immunohistochemistry assay. Tumors were categorized as Trop-2–low, –medium, or –-high expressers on the basis of H-score, which is a weighted summation of percent staining. In addition, germline BRCA1/2 mutation status was determined at baseline.

Mutation status was known for 149 SG patients and 143 control patients. Of those, the majority (57% and 54%, respectively) were BRCA1/2 negative.

Among 151 SG patients for whom Trop-2 expression status was available, 56% had tumors of high expression; 26%, medium expression; and 18%, low expression. In the control group, Trop-2 expression was known in 139 patients, of whom 52% had tumors of high expression; 25%, medium expression; and 23%, low expression.

Hurvitz reported that, although median PFS among patients given SG decreased with decreasing Trop-2 expression, it remained longer than that seen with control treatment. In patients with tumors of Trop-2–high status, median PFS was 6.9 months with SG, vs. 2.5 for patients who underwent control treatment. This fell to 5.6 months vs. 2.2 months in the Trop-2–medium group and 2.7 months vs 1.6 months in Trop-2–low group.

A similar pattern was seen for overall survival. In the Trop-2–high group, median overall survival was 14.2 months with SG, vs. 6.9 months with control therapy; 14.9 months vs. 6.9 months in the Trop-2–medium group; and 9.3 months vs. 7.6 months in the Trop-2–low group.

Again, the objective response rate fell from 44% to 38% and then to 22% with SG in the Trop-2–high, –medium, and –low groups, compared with 1%, 11%, and 6%, respectively, with control treatment.

There did not seem to be any interaction between Trop-2 expression and treatment-related adverse events of special interest. Rates of neutropenia, diarrhea, and anemia were consistently higher in SG-treated patients than in those given placebo.

Hurvitz said the objective response rate was markedly higher with SG vs. control treatment in both BRCA1/2-positive and -negative patients, at 19% vs. 6% in the positive group and 33% vs. 6% in the negative group.

This was reflected in improved median PFS with SG in both subgroups, at 4.6 months vs. 2.5 months with control therapy in BRCA1/2-positive patients and 4.9 months vs. 1.6 months in BRCA1/2-negative patients.

Overall survival was 15.6 months with SG, vs. 4.4 months with control treatment in BRCA1/2-positive patients. In BRCA1/2-negative patients, the respective figures were 10.9 months and 7.0 months.

The study was sponsored by Immunomedics. Hurvitz has financial ties to Immunomedics and multiple other pharmaceutical companies. Litton has financial ties to multiple companies, including Medscape and companies developing and marketing breast cancer therapies.

This article first appeared on Medscape.com.

The antibody–drug conjugate sacituzumab govitecan (SG) appears to be effective across biomarker subgroups for women with metastatic triple-negative breast cancer (mTNBC) that has progressed after multiple lines of therapy, a biomarker evaluation from the phase 3 ASCENT trial shows.

But both an observer and the lead study author cautioned that the results were hypothesis generating.

Nonetheless, the data suggest the drug yields good survival outcomes in comparison with placebo in both BRCA1/2-positive and -negative patients and is effective even for those with low expression of the target protein, trophoblast cell surface antigen 2 (Trop-2).

The research was presented at the San Antonio Breast Cancer Symposium (SABCS) 2020.

Study presenter Sara Hurvitz, MD, Jonsson Comprehensive Cancer Center, University of California, Los Angeles, urged caution in interpreting the data, given the small sample sizes in the Trop-2–low subgroup and germline BRCA1/2-positive subgroup.

Jennifer K. Litton, MD, University of Texas MD Anderson Cancer Center, Houston, Texas, who was not involved in the research, echoed those comments.

She told Medscape Medical News that the numbers, particularly for the BRCA1/2 analysis, were “very small.”

She added: “This was not a prespecified group, so it represents an interesting analysis to be hypothesis generating for future studies but not anything applicable to current clinical practice.”

Nevertheless, Litton said the data from the primary analysis of ASCENT remain “practice changing” for women with mTNBC who have received at least two previous lines of therapy.

As to whether SG will eventually move beyond this advanced setting, she emphasized that “more trials would need to be done and reported evaluating its role in other settings, and hopefully expanding its usefulness for patients.”

SG is a first-in-class drug comprising an antibody directed at Trop-2, which is highly expressed in breast cancer, and linked to SN-38, the active metabolite of irinotecan.

On the basis of positive phase 1/2 trial data, SG was granted accelerated approval by the US Food and Drug Administration for patients with mTNBC who experience disease progression after at least two prior therapies.

As reported by Medscape Medical News, primary results from ASCENT that were presented at ESMO 2020 showed that SG improved progression-free survival (PFS) by nearly 4 months and overall survival by more than 5 months for women with pretreated mTNBC compared to chemotherapy.
 

Study details

At SABCS, Hurvitz presented an exploratory biomarker evaluation of data from the trial regarding the association between SG efficacy and Trop-2 expression, as well as germline BRCA1/2 mutation status.

She reminded the audience that, in ASCENT, 529 patients with mTNBC who had experienced disease progression after undergoing at least two chemotherapy regimens for advanced disease were randomly assigned in a 1:1 ratio to receive intravenous SG on days 1 and 8 of a 21-day cycle or physician’s choice of treatment.

Treatment was continued until disease progression or unacceptable toxicity occurred.

For the current analysis, which focused on patients who did not have brain metastases, the team studied primary or metastatic archival biopsy or surgical specimens collected at study entry.

These were analyzed using a validated immunohistochemistry assay. Tumors were categorized as Trop-2–low, –medium, or –-high expressers on the basis of H-score, which is a weighted summation of percent staining. In addition, germline BRCA1/2 mutation status was determined at baseline.

Mutation status was known for 149 SG patients and 143 control patients. Of those, the majority (57% and 54%, respectively) were BRCA1/2 negative.

Among 151 SG patients for whom Trop-2 expression status was available, 56% had tumors of high expression; 26%, medium expression; and 18%, low expression. In the control group, Trop-2 expression was known in 139 patients, of whom 52% had tumors of high expression; 25%, medium expression; and 23%, low expression.

Hurvitz reported that, although median PFS among patients given SG decreased with decreasing Trop-2 expression, it remained longer than that seen with control treatment. In patients with tumors of Trop-2–high status, median PFS was 6.9 months with SG, vs. 2.5 for patients who underwent control treatment. This fell to 5.6 months vs. 2.2 months in the Trop-2–medium group and 2.7 months vs 1.6 months in Trop-2–low group.

A similar pattern was seen for overall survival. In the Trop-2–high group, median overall survival was 14.2 months with SG, vs. 6.9 months with control therapy; 14.9 months vs. 6.9 months in the Trop-2–medium group; and 9.3 months vs. 7.6 months in the Trop-2–low group.

Again, the objective response rate fell from 44% to 38% and then to 22% with SG in the Trop-2–high, –medium, and –low groups, compared with 1%, 11%, and 6%, respectively, with control treatment.

There did not seem to be any interaction between Trop-2 expression and treatment-related adverse events of special interest. Rates of neutropenia, diarrhea, and anemia were consistently higher in SG-treated patients than in those given placebo.

Hurvitz said the objective response rate was markedly higher with SG vs. control treatment in both BRCA1/2-positive and -negative patients, at 19% vs. 6% in the positive group and 33% vs. 6% in the negative group.

This was reflected in improved median PFS with SG in both subgroups, at 4.6 months vs. 2.5 months with control therapy in BRCA1/2-positive patients and 4.9 months vs. 1.6 months in BRCA1/2-negative patients.

Overall survival was 15.6 months with SG, vs. 4.4 months with control treatment in BRCA1/2-positive patients. In BRCA1/2-negative patients, the respective figures were 10.9 months and 7.0 months.

The study was sponsored by Immunomedics. Hurvitz has financial ties to Immunomedics and multiple other pharmaceutical companies. Litton has financial ties to multiple companies, including Medscape and companies developing and marketing breast cancer therapies.

This article first appeared on Medscape.com.

The antibody–drug conjugate sacituzumab govitecan (SG) appears to be effective across biomarker subgroups for women with metastatic triple-negative breast cancer (mTNBC) that has progressed after multiple lines of therapy, a biomarker evaluation from the phase 3 ASCENT trial shows.

But both an observer and the lead study author cautioned that the results were hypothesis generating.

Nonetheless, the data suggest the drug yields good survival outcomes in comparison with placebo in both BRCA1/2-positive and -negative patients and is effective even for those with low expression of the target protein, trophoblast cell surface antigen 2 (Trop-2).

The research was presented at the San Antonio Breast Cancer Symposium (SABCS) 2020.

Study presenter Sara Hurvitz, MD, Jonsson Comprehensive Cancer Center, University of California, Los Angeles, urged caution in interpreting the data, given the small sample sizes in the Trop-2–low subgroup and germline BRCA1/2-positive subgroup.

Jennifer K. Litton, MD, University of Texas MD Anderson Cancer Center, Houston, Texas, who was not involved in the research, echoed those comments.

She told Medscape Medical News that the numbers, particularly for the BRCA1/2 analysis, were “very small.”

She added: “This was not a prespecified group, so it represents an interesting analysis to be hypothesis generating for future studies but not anything applicable to current clinical practice.”

Nevertheless, Litton said the data from the primary analysis of ASCENT remain “practice changing” for women with mTNBC who have received at least two previous lines of therapy.

As to whether SG will eventually move beyond this advanced setting, she emphasized that “more trials would need to be done and reported evaluating its role in other settings, and hopefully expanding its usefulness for patients.”

SG is a first-in-class drug comprising an antibody directed at Trop-2, which is highly expressed in breast cancer, and linked to SN-38, the active metabolite of irinotecan.

On the basis of positive phase 1/2 trial data, SG was granted accelerated approval by the US Food and Drug Administration for patients with mTNBC who experience disease progression after at least two prior therapies.

As reported by Medscape Medical News, primary results from ASCENT that were presented at ESMO 2020 showed that SG improved progression-free survival (PFS) by nearly 4 months and overall survival by more than 5 months for women with pretreated mTNBC compared to chemotherapy.
 

Study details

At SABCS, Hurvitz presented an exploratory biomarker evaluation of data from the trial regarding the association between SG efficacy and Trop-2 expression, as well as germline BRCA1/2 mutation status.

She reminded the audience that, in ASCENT, 529 patients with mTNBC who had experienced disease progression after undergoing at least two chemotherapy regimens for advanced disease were randomly assigned in a 1:1 ratio to receive intravenous SG on days 1 and 8 of a 21-day cycle or physician’s choice of treatment.

Treatment was continued until disease progression or unacceptable toxicity occurred.

For the current analysis, which focused on patients who did not have brain metastases, the team studied primary or metastatic archival biopsy or surgical specimens collected at study entry.

These were analyzed using a validated immunohistochemistry assay. Tumors were categorized as Trop-2–low, –medium, or –-high expressers on the basis of H-score, which is a weighted summation of percent staining. In addition, germline BRCA1/2 mutation status was determined at baseline.

Mutation status was known for 149 SG patients and 143 control patients. Of those, the majority (57% and 54%, respectively) were BRCA1/2 negative.

Among 151 SG patients for whom Trop-2 expression status was available, 56% had tumors of high expression; 26%, medium expression; and 18%, low expression. In the control group, Trop-2 expression was known in 139 patients, of whom 52% had tumors of high expression; 25%, medium expression; and 23%, low expression.

Hurvitz reported that, although median PFS among patients given SG decreased with decreasing Trop-2 expression, it remained longer than that seen with control treatment. In patients with tumors of Trop-2–high status, median PFS was 6.9 months with SG, vs. 2.5 for patients who underwent control treatment. This fell to 5.6 months vs. 2.2 months in the Trop-2–medium group and 2.7 months vs 1.6 months in Trop-2–low group.

A similar pattern was seen for overall survival. In the Trop-2–high group, median overall survival was 14.2 months with SG, vs. 6.9 months with control therapy; 14.9 months vs. 6.9 months in the Trop-2–medium group; and 9.3 months vs. 7.6 months in the Trop-2–low group.

Again, the objective response rate fell from 44% to 38% and then to 22% with SG in the Trop-2–high, –medium, and –low groups, compared with 1%, 11%, and 6%, respectively, with control treatment.

There did not seem to be any interaction between Trop-2 expression and treatment-related adverse events of special interest. Rates of neutropenia, diarrhea, and anemia were consistently higher in SG-treated patients than in those given placebo.

Hurvitz said the objective response rate was markedly higher with SG vs. control treatment in both BRCA1/2-positive and -negative patients, at 19% vs. 6% in the positive group and 33% vs. 6% in the negative group.

This was reflected in improved median PFS with SG in both subgroups, at 4.6 months vs. 2.5 months with control therapy in BRCA1/2-positive patients and 4.9 months vs. 1.6 months in BRCA1/2-negative patients.

Overall survival was 15.6 months with SG, vs. 4.4 months with control treatment in BRCA1/2-positive patients. In BRCA1/2-negative patients, the respective figures were 10.9 months and 7.0 months.

The study was sponsored by Immunomedics. Hurvitz has financial ties to Immunomedics and multiple other pharmaceutical companies. Litton has financial ties to multiple companies, including Medscape and companies developing and marketing breast cancer therapies.

This article first appeared on Medscape.com.

A phase 1 first-in-human study demonstrated synthetic T-cell receptor and antigen receptor (STAR) technical feasibility, clinical safety and efficacy in treating CD19+ relapsed/refractory B-cell acute lymphoblastic leukemia (ALL), according to senior study author Peihua Lu, MD, Beijing Lu Daopei Institute of Hematology, Beijing, China. STAR T cells were found to be superior to conventional chimeric antigen receptor (CAR) T cells with respect to signaling capacity, cytokine production and antitumor potency in an animal model study, according to Dr. Lu’s presentation at the annual meeting of the American Society of Hematology.
 

Remission can be improved

While CAR T-cell therapy has demonstrated high response rates in patients with B-cell malignancies, remission durability and safety can be improved, Dr Lu said. Her team developed STAR, a novel double-chain chimeric receptor consisting of two protein modules, each containing an antibody light or heavy chain variable region, the T cell receptor (TCR) alpha or beta chain constant region fused to the OX-40 costimulatory domain. The 2 modules are linked by a self-cleaving Furin-p2A sequence that allows the modules to be proteolytically separated and reconstituted. In preclinical in vitro research, STAR-T-cells showed a much faster and stronger cell activation, compared with CAR T cells and superior target cell–killing ability, and higher levels of interferon-y after coculture with the CD19+ Raji cell. In a murine in vivo study, STAR-T cells had higher antileukemia activity, compared with CAR-T cells, and significantly inhibited tumor cell growth, Dr. Lu stated. All animals were sustainably tumor free 5 days after STAR-T cell injection.

The first-in-human study included 18 CD19+ relapsed/refractory B-cell ALL (median age 22.5 years) patients, with a median bone marrow blast level pre–CAR T of 15.3%.

The manufacture success rate was 100% and took about 9 days (7-13). Transduction efficacy was 57.4% (41.0%-78.2%). Subjects received a conditioning regimen of intravenous fludarabine (25mg/m² per day) and cyclophosphamide (250mg/m² per day) for 3 days followed by a single STAR T-cell infusion. Patients were given the option, after they achieved complete remission (CR), of proceeding to consolidation allogeneic hematopoietic stem cell transplantation (allo-HSCT).
 

100% MRD negative

On day 14 following transplant, 18/18 had achieved minimal residual disease–negative complete response/CRi (with incomplete hematologic recovery). One patient relapsed after allogeneic transplant, becoming minimal residual disease positive on day 28. After a median follow-up of 105 days, 11/18 bridged into allo-HSCT without relapse. Among the seven patients who did not undergo allo-HSCT, one relapsed on day 58 and died on day 63. The patient had CNS leukemia and 87% bone marrow blasts before receiving STAR T. The others, Dr. Lu said, remain in CR.

Mild cytokine release syndrome (CRS) occurred in only 10 patients (55.6%), with grade 1 CRS in 8 patients and grade 2 in 2 patients. Grade 3 neurotoxicity occurred in two patients.

Reporting cellular kinetics of STAR T cells in peripheral blood by fluorescence-activated cell sorting (FACS)/quantitative PCR showed the highest STAR-T proliferation ratio (STAR/CD3) of 88.1%. Median peak level was 4.9 x 10⁴ copies number/mcg genomic DNA. The peak time was day 8.5 and the longest detection time was 6 months after STAR T infusion (STAR T ratio, 0.46%-1.85%). High in vivo proliferation and persistence was observed regardless of infusion dose.
 

STAR holds promise

Dr. Lu concluded: “The phase 1 first-in-human study demonstrated technical feasibility, clinical safety and efficacy of STAR T in treating CD19+ relapsed/refractory B-cell acute lymphoblastic leukemia.” She noted also that long-term observation of these patients and studies of larger patient cohorts are warranted to evaluate a beneficial advantage of the STAR T over the conventional CAR T product.

Asked about future directions in the discussion period, Dr. Lu responded that “this product holds great promise, No. 1 because it is actually between a T-cell receptor and a CAR T, and so clearly has fewer side effects. It potentially can recognize and target the tumor intracellular antigen better than a conventional CAR T. It is easier to construct – and holds great promise for treating solid tumors.”

Dr. Lu reported that she had no relevant disclosures.

SOURCE: Lu P et al. ASH 2020, Abstract 270.

A phase 1 first-in-human study demonstrated synthetic T-cell receptor and antigen receptor (STAR) technical feasibility, clinical safety and efficacy in treating CD19+ relapsed/refractory B-cell acute lymphoblastic leukemia (ALL), according to senior study author Peihua Lu, MD, Beijing Lu Daopei Institute of Hematology, Beijing, China. STAR T cells were found to be superior to conventional chimeric antigen receptor (CAR) T cells with respect to signaling capacity, cytokine production and antitumor potency in an animal model study, according to Dr. Lu’s presentation at the annual meeting of the American Society of Hematology.
 

Remission can be improved

While CAR T-cell therapy has demonstrated high response rates in patients with B-cell malignancies, remission durability and safety can be improved, Dr Lu said. Her team developed STAR, a novel double-chain chimeric receptor consisting of two protein modules, each containing an antibody light or heavy chain variable region, the T cell receptor (TCR) alpha or beta chain constant region fused to the OX-40 costimulatory domain. The 2 modules are linked by a self-cleaving Furin-p2A sequence that allows the modules to be proteolytically separated and reconstituted. In preclinical in vitro research, STAR-T-cells showed a much faster and stronger cell activation, compared with CAR T cells and superior target cell–killing ability, and higher levels of interferon-y after coculture with the CD19+ Raji cell. In a murine in vivo study, STAR-T cells had higher antileukemia activity, compared with CAR-T cells, and significantly inhibited tumor cell growth, Dr. Lu stated. All animals were sustainably tumor free 5 days after STAR-T cell injection.

The first-in-human study included 18 CD19+ relapsed/refractory B-cell ALL (median age 22.5 years) patients, with a median bone marrow blast level pre–CAR T of 15.3%.

The manufacture success rate was 100% and took about 9 days (7-13). Transduction efficacy was 57.4% (41.0%-78.2%). Subjects received a conditioning regimen of intravenous fludarabine (25mg/m² per day) and cyclophosphamide (250mg/m² per day) for 3 days followed by a single STAR T-cell infusion. Patients were given the option, after they achieved complete remission (CR), of proceeding to consolidation allogeneic hematopoietic stem cell transplantation (allo-HSCT).
 

100% MRD negative

On day 14 following transplant, 18/18 had achieved minimal residual disease–negative complete response/CRi (with incomplete hematologic recovery). One patient relapsed after allogeneic transplant, becoming minimal residual disease positive on day 28. After a median follow-up of 105 days, 11/18 bridged into allo-HSCT without relapse. Among the seven patients who did not undergo allo-HSCT, one relapsed on day 58 and died on day 63. The patient had CNS leukemia and 87% bone marrow blasts before receiving STAR T. The others, Dr. Lu said, remain in CR.

Mild cytokine release syndrome (CRS) occurred in only 10 patients (55.6%), with grade 1 CRS in 8 patients and grade 2 in 2 patients. Grade 3 neurotoxicity occurred in two patients.

Reporting cellular kinetics of STAR T cells in peripheral blood by fluorescence-activated cell sorting (FACS)/quantitative PCR showed the highest STAR-T proliferation ratio (STAR/CD3) of 88.1%. Median peak level was 4.9 x 10⁴ copies number/mcg genomic DNA. The peak time was day 8.5 and the longest detection time was 6 months after STAR T infusion (STAR T ratio, 0.46%-1.85%). High in vivo proliferation and persistence was observed regardless of infusion dose.
 

STAR holds promise

Dr. Lu concluded: “The phase 1 first-in-human study demonstrated technical feasibility, clinical safety and efficacy of STAR T in treating CD19+ relapsed/refractory B-cell acute lymphoblastic leukemia.” She noted also that long-term observation of these patients and studies of larger patient cohorts are warranted to evaluate a beneficial advantage of the STAR T over the conventional CAR T product.

Asked about future directions in the discussion period, Dr. Lu responded that “this product holds great promise, No. 1 because it is actually between a T-cell receptor and a CAR T, and so clearly has fewer side effects. It potentially can recognize and target the tumor intracellular antigen better than a conventional CAR T. It is easier to construct – and holds great promise for treating solid tumors.”

Dr. Lu reported that she had no relevant disclosures.

SOURCE: Lu P et al. ASH 2020, Abstract 270.

A phase 1 first-in-human study demonstrated synthetic T-cell receptor and antigen receptor (STAR) technical feasibility, clinical safety and efficacy in treating CD19+ relapsed/refractory B-cell acute lymphoblastic leukemia (ALL), according to senior study author Peihua Lu, MD, Beijing Lu Daopei Institute of Hematology, Beijing, China. STAR T cells were found to be superior to conventional chimeric antigen receptor (CAR) T cells with respect to signaling capacity, cytokine production and antitumor potency in an animal model study, according to Dr. Lu’s presentation at the annual meeting of the American Society of Hematology.
 

Remission can be improved

While CAR T-cell therapy has demonstrated high response rates in patients with B-cell malignancies, remission durability and safety can be improved, Dr Lu said. Her team developed STAR, a novel double-chain chimeric receptor consisting of two protein modules, each containing an antibody light or heavy chain variable region, the T cell receptor (TCR) alpha or beta chain constant region fused to the OX-40 costimulatory domain. The 2 modules are linked by a self-cleaving Furin-p2A sequence that allows the modules to be proteolytically separated and reconstituted. In preclinical in vitro research, STAR-T-cells showed a much faster and stronger cell activation, compared with CAR T cells and superior target cell–killing ability, and higher levels of interferon-y after coculture with the CD19+ Raji cell. In a murine in vivo study, STAR-T cells had higher antileukemia activity, compared with CAR-T cells, and significantly inhibited tumor cell growth, Dr. Lu stated. All animals were sustainably tumor free 5 days after STAR-T cell injection.

The first-in-human study included 18 CD19+ relapsed/refractory B-cell ALL (median age 22.5 years) patients, with a median bone marrow blast level pre–CAR T of 15.3%.

The manufacture success rate was 100% and took about 9 days (7-13). Transduction efficacy was 57.4% (41.0%-78.2%). Subjects received a conditioning regimen of intravenous fludarabine (25mg/m² per day) and cyclophosphamide (250mg/m² per day) for 3 days followed by a single STAR T-cell infusion. Patients were given the option, after they achieved complete remission (CR), of proceeding to consolidation allogeneic hematopoietic stem cell transplantation (allo-HSCT).
 

100% MRD negative

On day 14 following transplant, 18/18 had achieved minimal residual disease–negative complete response/CRi (with incomplete hematologic recovery). One patient relapsed after allogeneic transplant, becoming minimal residual disease positive on day 28. After a median follow-up of 105 days, 11/18 bridged into allo-HSCT without relapse. Among the seven patients who did not undergo allo-HSCT, one relapsed on day 58 and died on day 63. The patient had CNS leukemia and 87% bone marrow blasts before receiving STAR T. The others, Dr. Lu said, remain in CR.

Mild cytokine release syndrome (CRS) occurred in only 10 patients (55.6%), with grade 1 CRS in 8 patients and grade 2 in 2 patients. Grade 3 neurotoxicity occurred in two patients.

Reporting cellular kinetics of STAR T cells in peripheral blood by fluorescence-activated cell sorting (FACS)/quantitative PCR showed the highest STAR-T proliferation ratio (STAR/CD3) of 88.1%. Median peak level was 4.9 x 10⁴ copies number/mcg genomic DNA. The peak time was day 8.5 and the longest detection time was 6 months after STAR T infusion (STAR T ratio, 0.46%-1.85%). High in vivo proliferation and persistence was observed regardless of infusion dose.
 

STAR holds promise

Dr. Lu concluded: “The phase 1 first-in-human study demonstrated technical feasibility, clinical safety and efficacy of STAR T in treating CD19+ relapsed/refractory B-cell acute lymphoblastic leukemia.” She noted also that long-term observation of these patients and studies of larger patient cohorts are warranted to evaluate a beneficial advantage of the STAR T over the conventional CAR T product.

Asked about future directions in the discussion period, Dr. Lu responded that “this product holds great promise, No. 1 because it is actually between a T-cell receptor and a CAR T, and so clearly has fewer side effects. It potentially can recognize and target the tumor intracellular antigen better than a conventional CAR T. It is easier to construct – and holds great promise for treating solid tumors.”

Dr. Lu reported that she had no relevant disclosures.

SOURCE: Lu P et al. ASH 2020, Abstract 270.

The beneficial effects of sacubitril/valsartan on reverse cardiac remodeling in patients with heart failure and reduced ejection fraction have been well established, but those benefits haven’t been as clearly demonstrated to carry over to HFrEF patients who also have type 2 diabetes mellitus (T2DM).

Now, a post-hoc analysis of a pivotal clinical trial reports that those benefits do extend to patients with HFrEF and T2DM.

“It’s really not about a Sophie’s choice of whether you give this or that drug in these patients,” said corresponding author Javed Butler, MD, MPH, MBA. “We really ought to be giving all of these drugs – the angiotensin receptor neprilysin inhibitors (ARNIs) and sodium-glucose transporter 2 (SGLT-2) inhibitors – to our patients for the best outcomes.”

The post-hoc analysis, published in JACC: Heart Failure, evaluated 361 patients with T2DM who were enrolled in the PROVE-HF trial of sac/val therapy for HF, published in JAMA.

PROVE-HF evaluated biomarkers, myocardial remodeling, and outcomes through a year of treatment with sac/val. The primary endpoint was the level of changes in natriuretic peptide (NT-proBNP) concentrations, left-ventricle ejection fraction (LVEF) and overall Kansas City Cardiomyopathy Questionnaire (KCCQ)-23 scores through 12 months of treatment.

The post hoc study reported that baseline NT-proBNP concentrations were higher in the DM patients (854 pg/mL vs. 706 pg/mL), but at 12 months those levels were 513 and 441 pg/mL, respectively.

LVEF changed similarly from baseline to 12 months in both groups: from 28.3% to 37% in the DM patients and from 28.1% to 38.34% in non-DM patients. Overall KCCQ-23 scores improved similarly in both groups, but longitudinal analyses found modestly higher gains in the T2DM group, 9.3 vs. 8.6 points (P = .07).

“The real reason I wanted to do this study is that I’m a huge fan of all the SGLT-2 inhibitors, and I’m very involved in those trials, and there is right now so much momentum behind SGLT-2 inhibitors that I don’t want people to forget that ARNI is still the base therapy for HF,” said Dr. Butler, chair of cardiovascular research and the department of medicine at the University of Mississippi in Jackson.

He noted that the size of the diabetes cohort in PROVE-HF “is a nonissue” for evaluating power of the post hoc analysis because it tracked key measures in the study population continuously at eight intervals over the 12 months.

The analysis further demonstrates the synergistic effects of ARNI and SGLT-2 inhibitors in patients with T2DM and HF that were also reported in the PARADIGM-HF study, Dr. Butler said.

“We have sort of moved on, saying that SGLT-2 inhibitors have a benefit on the heart, but the reverse is also true: ARNIs are still heart failure drugs, and we don’t think of them as diabetes drugs, but the PARADIGM-HF data showed that there was a substantial reduction in hemoglobin A1c in those who had diabetes,” he said.

The researchers noted that an absence of a control group may contribute to an overestimation of reverse cardiac remodeling in the T2DM patients, and that the PROVE-HF study wasn’t prospectively powered to delineate differences in how sac/val therapy affected patients with or without diabetes. “Future investigations seeking to evaluate differences by T2DM status after sacubitril/valsartan initiation may use our findings to plan prospective sample sizes,” the researchers wrote.

Dr. Butler disclosed financial relationships with Abbott, Amgen, Array, AstraZeneca, Bayer, Boehringer Ingelheim, CVRx, Eli Lilly, G3 Pharmaceutical, Impulse Dynamics, Innolife, Janssen, Luitpold, Medtronic, Merck, Novartis, Novo Nordisk, Relypsa, Sequana, StealthPeptide and Vifor. Lead author Muhammad Shahzeb Khan, MD, MSc, a professor at the University of Mississippi, has no relevant financial relationships to disclose.

SOURCE: Kahn MS et al. JACC: HF. 2020 Dec 9. doi: 10.1016/j.jchf.2020.09.014.
 

The beneficial effects of sacubitril/valsartan on reverse cardiac remodeling in patients with heart failure and reduced ejection fraction have been well established, but those benefits haven’t been as clearly demonstrated to carry over to HFrEF patients who also have type 2 diabetes mellitus (T2DM).

Now, a post-hoc analysis of a pivotal clinical trial reports that those benefits do extend to patients with HFrEF and T2DM.

“It’s really not about a Sophie’s choice of whether you give this or that drug in these patients,” said corresponding author Javed Butler, MD, MPH, MBA. “We really ought to be giving all of these drugs – the angiotensin receptor neprilysin inhibitors (ARNIs) and sodium-glucose transporter 2 (SGLT-2) inhibitors – to our patients for the best outcomes.”

The post-hoc analysis, published in JACC: Heart Failure, evaluated 361 patients with T2DM who were enrolled in the PROVE-HF trial of sac/val therapy for HF, published in JAMA.

PROVE-HF evaluated biomarkers, myocardial remodeling, and outcomes through a year of treatment with sac/val. The primary endpoint was the level of changes in natriuretic peptide (NT-proBNP) concentrations, left-ventricle ejection fraction (LVEF) and overall Kansas City Cardiomyopathy Questionnaire (KCCQ)-23 scores through 12 months of treatment.

The post hoc study reported that baseline NT-proBNP concentrations were higher in the DM patients (854 pg/mL vs. 706 pg/mL), but at 12 months those levels were 513 and 441 pg/mL, respectively.

LVEF changed similarly from baseline to 12 months in both groups: from 28.3% to 37% in the DM patients and from 28.1% to 38.34% in non-DM patients. Overall KCCQ-23 scores improved similarly in both groups, but longitudinal analyses found modestly higher gains in the T2DM group, 9.3 vs. 8.6 points (P = .07).

“The real reason I wanted to do this study is that I’m a huge fan of all the SGLT-2 inhibitors, and I’m very involved in those trials, and there is right now so much momentum behind SGLT-2 inhibitors that I don’t want people to forget that ARNI is still the base therapy for HF,” said Dr. Butler, chair of cardiovascular research and the department of medicine at the University of Mississippi in Jackson.

He noted that the size of the diabetes cohort in PROVE-HF “is a nonissue” for evaluating power of the post hoc analysis because it tracked key measures in the study population continuously at eight intervals over the 12 months.

The analysis further demonstrates the synergistic effects of ARNI and SGLT-2 inhibitors in patients with T2DM and HF that were also reported in the PARADIGM-HF study, Dr. Butler said.

“We have sort of moved on, saying that SGLT-2 inhibitors have a benefit on the heart, but the reverse is also true: ARNIs are still heart failure drugs, and we don’t think of them as diabetes drugs, but the PARADIGM-HF data showed that there was a substantial reduction in hemoglobin A1c in those who had diabetes,” he said.

The researchers noted that an absence of a control group may contribute to an overestimation of reverse cardiac remodeling in the T2DM patients, and that the PROVE-HF study wasn’t prospectively powered to delineate differences in how sac/val therapy affected patients with or without diabetes. “Future investigations seeking to evaluate differences by T2DM status after sacubitril/valsartan initiation may use our findings to plan prospective sample sizes,” the researchers wrote.

Dr. Butler disclosed financial relationships with Abbott, Amgen, Array, AstraZeneca, Bayer, Boehringer Ingelheim, CVRx, Eli Lilly, G3 Pharmaceutical, Impulse Dynamics, Innolife, Janssen, Luitpold, Medtronic, Merck, Novartis, Novo Nordisk, Relypsa, Sequana, StealthPeptide and Vifor. Lead author Muhammad Shahzeb Khan, MD, MSc, a professor at the University of Mississippi, has no relevant financial relationships to disclose.

SOURCE: Kahn MS et al. JACC: HF. 2020 Dec 9. doi: 10.1016/j.jchf.2020.09.014.
 

The beneficial effects of sacubitril/valsartan on reverse cardiac remodeling in patients with heart failure and reduced ejection fraction have been well established, but those benefits haven’t been as clearly demonstrated to carry over to HFrEF patients who also have type 2 diabetes mellitus (T2DM).

Now, a post-hoc analysis of a pivotal clinical trial reports that those benefits do extend to patients with HFrEF and T2DM.

“It’s really not about a Sophie’s choice of whether you give this or that drug in these patients,” said corresponding author Javed Butler, MD, MPH, MBA. “We really ought to be giving all of these drugs – the angiotensin receptor neprilysin inhibitors (ARNIs) and sodium-glucose transporter 2 (SGLT-2) inhibitors – to our patients for the best outcomes.”

The post-hoc analysis, published in JACC: Heart Failure, evaluated 361 patients with T2DM who were enrolled in the PROVE-HF trial of sac/val therapy for HF, published in JAMA.

PROVE-HF evaluated biomarkers, myocardial remodeling, and outcomes through a year of treatment with sac/val. The primary endpoint was the level of changes in natriuretic peptide (NT-proBNP) concentrations, left-ventricle ejection fraction (LVEF) and overall Kansas City Cardiomyopathy Questionnaire (KCCQ)-23 scores through 12 months of treatment.

The post hoc study reported that baseline NT-proBNP concentrations were higher in the DM patients (854 pg/mL vs. 706 pg/mL), but at 12 months those levels were 513 and 441 pg/mL, respectively.

LVEF changed similarly from baseline to 12 months in both groups: from 28.3% to 37% in the DM patients and from 28.1% to 38.34% in non-DM patients. Overall KCCQ-23 scores improved similarly in both groups, but longitudinal analyses found modestly higher gains in the T2DM group, 9.3 vs. 8.6 points (P = .07).

“The real reason I wanted to do this study is that I’m a huge fan of all the SGLT-2 inhibitors, and I’m very involved in those trials, and there is right now so much momentum behind SGLT-2 inhibitors that I don’t want people to forget that ARNI is still the base therapy for HF,” said Dr. Butler, chair of cardiovascular research and the department of medicine at the University of Mississippi in Jackson.

He noted that the size of the diabetes cohort in PROVE-HF “is a nonissue” for evaluating power of the post hoc analysis because it tracked key measures in the study population continuously at eight intervals over the 12 months.

The analysis further demonstrates the synergistic effects of ARNI and SGLT-2 inhibitors in patients with T2DM and HF that were also reported in the PARADIGM-HF study, Dr. Butler said.

“We have sort of moved on, saying that SGLT-2 inhibitors have a benefit on the heart, but the reverse is also true: ARNIs are still heart failure drugs, and we don’t think of them as diabetes drugs, but the PARADIGM-HF data showed that there was a substantial reduction in hemoglobin A1c in those who had diabetes,” he said.

The researchers noted that an absence of a control group may contribute to an overestimation of reverse cardiac remodeling in the T2DM patients, and that the PROVE-HF study wasn’t prospectively powered to delineate differences in how sac/val therapy affected patients with or without diabetes. “Future investigations seeking to evaluate differences by T2DM status after sacubitril/valsartan initiation may use our findings to plan prospective sample sizes,” the researchers wrote.

Dr. Butler disclosed financial relationships with Abbott, Amgen, Array, AstraZeneca, Bayer, Boehringer Ingelheim, CVRx, Eli Lilly, G3 Pharmaceutical, Impulse Dynamics, Innolife, Janssen, Luitpold, Medtronic, Merck, Novartis, Novo Nordisk, Relypsa, Sequana, StealthPeptide and Vifor. Lead author Muhammad Shahzeb Khan, MD, MSc, a professor at the University of Mississippi, has no relevant financial relationships to disclose.

SOURCE: Kahn MS et al. JACC: HF. 2020 Dec 9. doi: 10.1016/j.jchf.2020.09.014.
 

The Diagnosis: Cutaneous B-cell Lymphoma  

Histopathology was suggestive of cutaneous B-cell lymphoma (Figure). Further immunohistochemical studies including Bcl-6 positivity and Bcl-2 negativity in the large atypical cells supported a diagnosis of primary cutaneous follicle center lymphoma (PCFCL). The designation of primary cutaneous B-cell lymphoma includes several different types of lymphoma, including marginal zone lymphoma, diffuse large B-cell lymphoma, and intravascular lymphoma. To be considered a primary cutaneous lymphoma, there must be evidence of the lymphoma in the skin without concomitant evidence of systemic involvement, as determined through a full staging workup. Primary cutaneous follicle center lymphoma is an indolent lymphoma that most commonly presents as solitary or grouped, pink to plum-colored papules, plaques, nodules, and tumors on the scalp, forehead, or back.¹ The lesions often are biopsied as suspected basal cell carcinomas or Merkel cell carcinomas (MCCs). Lesions on the face or scalp may easily evade diagnosis, as they initially may mimic rosacea or insect bites. Less common presentations include infiltrative lesions that cause rhinophymatous changes or scarring alopecia. Multifocal or disseminated lesions rarely can be observed. This case presentation is unique in its patchy appearance that clinically resembled angiosarcoma.² When identified and treated, the disease-specific 5-year survival rate for PCFCL is greater than 95%.³  

Merkel cell carcinoma was first described in 1972 and has been diagnosed with increasing frequency each year.⁴ It generally presents as an erythematous or violaceous, tender, indurated nodule on sun-exposed skin of the head or neck in elderly White men. However, other presentations have been reported, including papules, plaques, cystlike structures, pruritic tumors, pedunculated lesions, subcutaneous masses, and telangiectatic papules.⁵ Histopathologically, MCC is characterized by dermal nests and sheets of basaloid cells with finely granular salt and pepper-like chromatin. The histologic features can resemble other small blue cell tumors; therefore, the differential diagnosis can be broad.⁵ Immunohistochemistry that can confirm the diagnosis of MCC generally will be positive for cytokeratin 20 and neuroendocrine markers but negative for cytokeratin ⁷ and thyroid transcription factor ¹. Merkel cell carcinoma is an aggressive tumor with a high risk for local recurrence and distant metastasis that carries a generally poor prognosis, especially when there is evidence of metastatic disease at presentation.^5,6  

Rosacea can appear as telangiectatic patches, though generally not as one discrete patch limited to the forehead, as in our patient. Histologic features vary based on the age of the lesion and clinical variant. In early lesions there is a mild perivascular lymphoplasmacytic infiltrate within the dermis, while older lesions can have a mixed infiltrate crowded around vessels and adnexal structures. Granulomas often are seen near hair follicles and interspersed throughout the dermis with ectatic vessels and dermal edema.⁷  

Angiosarcoma is divided into 3 clinicopathological subtypes: idiopathic angiosarcoma of the head and neck, angiosarcoma in the setting of lymphedema, and postirradiation angiosarcoma.⁷ Idiopathic angiosarcoma most closely mimics PCFCL, as it can present as single or multifocal nodules, plaques, or patches. Histologically, the 3 groups appear similar with poorly circumscribed, infiltrative, dermal tumors. The neoplastic endothelial cells have large hyperchromatic nuclei that protrude into vascular lumens. The prognosis for idiopathic angiosarcoma of the head and neck is poor, with a 5-year survival rate of 15% to 34%, which often is due to delayed diagnosis.⁷ 

Pigmented purpuric dermatoses (PPDs) are chronic skin disorders characterized by purpura due to extravasation of blood from capillaries; the resulting hemosiderin deposition leads to pigmentation.⁷ There are various forms of PPD, which are classified into groups based on clinical appearance including Schamberg disease, purpura annularis telangiectodes of Majocchi, pigmented purpuric lichenoid dermatosis of Gougerot and Blum, lichen aureus, and others including eczematid and itching variants, which some consider to be distinct entities. Purpura annularis telangiectodes of Majocchi is the specific PPD that should be included in the clinical differential for PCFCL because it presents as annular patches with telangiectasias. Histologically, PPDs are characterized by a CD4⁺ lymphocytic infiltrate in the upper dermis with extravasated red blood cells and the presence of hemosiderin mostly within macrophages and a lack of true vasculitis. Clonality of the T cells has been shown, and there is some evidence that PPD may overlap with mycosis fungoides. However, this overlap mainly has been seen in patients with widespread lesions and would not apply to this case. In general, patients with PPD can be reassured of the benign process. In cases of widespread PPD, patients should be followed clinically to assess for progression to mycosis fungoides, though the likelihood is low.⁷  

Our patient underwent a full staging workup, which confirmed the diagnosis of PCFCL. He was treated with radiation to the forehead that resulted in clearance of the lesion. Approximately 2 years after the initial diagnosis, the patient was alive and well with no evidence of recurrence of PCFCL. 

In conclusion, it is imperative to identify unusual, macular, vascular-appearing patches, especially on the head and neck in older individuals. Because the clinical presentations of PCFCL, angiosarcoma, rosacea, MCC, and PPD can overlap with one another as well as with other entities, it is necessary to have a high level of suspicion and low threshold to biopsy these types of lesions, as outcomes can be drastically different. 

The Diagnosis: Cutaneous B-cell Lymphoma  

Histopathology was suggestive of cutaneous B-cell lymphoma (Figure). Further immunohistochemical studies including Bcl-6 positivity and Bcl-2 negativity in the large atypical cells supported a diagnosis of primary cutaneous follicle center lymphoma (PCFCL). The designation of primary cutaneous B-cell lymphoma includes several different types of lymphoma, including marginal zone lymphoma, diffuse large B-cell lymphoma, and intravascular lymphoma. To be considered a primary cutaneous lymphoma, there must be evidence of the lymphoma in the skin without concomitant evidence of systemic involvement, as determined through a full staging workup. Primary cutaneous follicle center lymphoma is an indolent lymphoma that most commonly presents as solitary or grouped, pink to plum-colored papules, plaques, nodules, and tumors on the scalp, forehead, or back.¹ The lesions often are biopsied as suspected basal cell carcinomas or Merkel cell carcinomas (MCCs). Lesions on the face or scalp may easily evade diagnosis, as they initially may mimic rosacea or insect bites. Less common presentations include infiltrative lesions that cause rhinophymatous changes or scarring alopecia. Multifocal or disseminated lesions rarely can be observed. This case presentation is unique in its patchy appearance that clinically resembled angiosarcoma.² When identified and treated, the disease-specific 5-year survival rate for PCFCL is greater than 95%.³  

Merkel cell carcinoma was first described in 1972 and has been diagnosed with increasing frequency each year.⁴ It generally presents as an erythematous or violaceous, tender, indurated nodule on sun-exposed skin of the head or neck in elderly White men. However, other presentations have been reported, including papules, plaques, cystlike structures, pruritic tumors, pedunculated lesions, subcutaneous masses, and telangiectatic papules.⁵ Histopathologically, MCC is characterized by dermal nests and sheets of basaloid cells with finely granular salt and pepper-like chromatin. The histologic features can resemble other small blue cell tumors; therefore, the differential diagnosis can be broad.⁵ Immunohistochemistry that can confirm the diagnosis of MCC generally will be positive for cytokeratin 20 and neuroendocrine markers but negative for cytokeratin ⁷ and thyroid transcription factor ¹. Merkel cell carcinoma is an aggressive tumor with a high risk for local recurrence and distant metastasis that carries a generally poor prognosis, especially when there is evidence of metastatic disease at presentation.^5,6  

Rosacea can appear as telangiectatic patches, though generally not as one discrete patch limited to the forehead, as in our patient. Histologic features vary based on the age of the lesion and clinical variant. In early lesions there is a mild perivascular lymphoplasmacytic infiltrate within the dermis, while older lesions can have a mixed infiltrate crowded around vessels and adnexal structures. Granulomas often are seen near hair follicles and interspersed throughout the dermis with ectatic vessels and dermal edema.⁷  

Angiosarcoma is divided into 3 clinicopathological subtypes: idiopathic angiosarcoma of the head and neck, angiosarcoma in the setting of lymphedema, and postirradiation angiosarcoma.⁷ Idiopathic angiosarcoma most closely mimics PCFCL, as it can present as single or multifocal nodules, plaques, or patches. Histologically, the 3 groups appear similar with poorly circumscribed, infiltrative, dermal tumors. The neoplastic endothelial cells have large hyperchromatic nuclei that protrude into vascular lumens. The prognosis for idiopathic angiosarcoma of the head and neck is poor, with a 5-year survival rate of 15% to 34%, which often is due to delayed diagnosis.⁷ 

Pigmented purpuric dermatoses (PPDs) are chronic skin disorders characterized by purpura due to extravasation of blood from capillaries; the resulting hemosiderin deposition leads to pigmentation.⁷ There are various forms of PPD, which are classified into groups based on clinical appearance including Schamberg disease, purpura annularis telangiectodes of Majocchi, pigmented purpuric lichenoid dermatosis of Gougerot and Blum, lichen aureus, and others including eczematid and itching variants, which some consider to be distinct entities. Purpura annularis telangiectodes of Majocchi is the specific PPD that should be included in the clinical differential for PCFCL because it presents as annular patches with telangiectasias. Histologically, PPDs are characterized by a CD4⁺ lymphocytic infiltrate in the upper dermis with extravasated red blood cells and the presence of hemosiderin mostly within macrophages and a lack of true vasculitis. Clonality of the T cells has been shown, and there is some evidence that PPD may overlap with mycosis fungoides. However, this overlap mainly has been seen in patients with widespread lesions and would not apply to this case. In general, patients with PPD can be reassured of the benign process. In cases of widespread PPD, patients should be followed clinically to assess for progression to mycosis fungoides, though the likelihood is low.⁷  

Our patient underwent a full staging workup, which confirmed the diagnosis of PCFCL. He was treated with radiation to the forehead that resulted in clearance of the lesion. Approximately 2 years after the initial diagnosis, the patient was alive and well with no evidence of recurrence of PCFCL. 

In conclusion, it is imperative to identify unusual, macular, vascular-appearing patches, especially on the head and neck in older individuals. Because the clinical presentations of PCFCL, angiosarcoma, rosacea, MCC, and PPD can overlap with one another as well as with other entities, it is necessary to have a high level of suspicion and low threshold to biopsy these types of lesions, as outcomes can be drastically different. 

The Diagnosis: Cutaneous B-cell Lymphoma  

Histopathology was suggestive of cutaneous B-cell lymphoma (Figure). Further immunohistochemical studies including Bcl-6 positivity and Bcl-2 negativity in the large atypical cells supported a diagnosis of primary cutaneous follicle center lymphoma (PCFCL). The designation of primary cutaneous B-cell lymphoma includes several different types of lymphoma, including marginal zone lymphoma, diffuse large B-cell lymphoma, and intravascular lymphoma. To be considered a primary cutaneous lymphoma, there must be evidence of the lymphoma in the skin without concomitant evidence of systemic involvement, as determined through a full staging workup. Primary cutaneous follicle center lymphoma is an indolent lymphoma that most commonly presents as solitary or grouped, pink to plum-colored papules, plaques, nodules, and tumors on the scalp, forehead, or back.¹ The lesions often are biopsied as suspected basal cell carcinomas or Merkel cell carcinomas (MCCs). Lesions on the face or scalp may easily evade diagnosis, as they initially may mimic rosacea or insect bites. Less common presentations include infiltrative lesions that cause rhinophymatous changes or scarring alopecia. Multifocal or disseminated lesions rarely can be observed. This case presentation is unique in its patchy appearance that clinically resembled angiosarcoma.² When identified and treated, the disease-specific 5-year survival rate for PCFCL is greater than 95%.³  

Merkel cell carcinoma was first described in 1972 and has been diagnosed with increasing frequency each year.⁴ It generally presents as an erythematous or violaceous, tender, indurated nodule on sun-exposed skin of the head or neck in elderly White men. However, other presentations have been reported, including papules, plaques, cystlike structures, pruritic tumors, pedunculated lesions, subcutaneous masses, and telangiectatic papules.⁵ Histopathologically, MCC is characterized by dermal nests and sheets of basaloid cells with finely granular salt and pepper-like chromatin. The histologic features can resemble other small blue cell tumors; therefore, the differential diagnosis can be broad.⁵ Immunohistochemistry that can confirm the diagnosis of MCC generally will be positive for cytokeratin 20 and neuroendocrine markers but negative for cytokeratin ⁷ and thyroid transcription factor ¹. Merkel cell carcinoma is an aggressive tumor with a high risk for local recurrence and distant metastasis that carries a generally poor prognosis, especially when there is evidence of metastatic disease at presentation.^5,6  

Rosacea can appear as telangiectatic patches, though generally not as one discrete patch limited to the forehead, as in our patient. Histologic features vary based on the age of the lesion and clinical variant. In early lesions there is a mild perivascular lymphoplasmacytic infiltrate within the dermis, while older lesions can have a mixed infiltrate crowded around vessels and adnexal structures. Granulomas often are seen near hair follicles and interspersed throughout the dermis with ectatic vessels and dermal edema.⁷  

Angiosarcoma is divided into 3 clinicopathological subtypes: idiopathic angiosarcoma of the head and neck, angiosarcoma in the setting of lymphedema, and postirradiation angiosarcoma.⁷ Idiopathic angiosarcoma most closely mimics PCFCL, as it can present as single or multifocal nodules, plaques, or patches. Histologically, the 3 groups appear similar with poorly circumscribed, infiltrative, dermal tumors. The neoplastic endothelial cells have large hyperchromatic nuclei that protrude into vascular lumens. The prognosis for idiopathic angiosarcoma of the head and neck is poor, with a 5-year survival rate of 15% to 34%, which often is due to delayed diagnosis.⁷ 

Pigmented purpuric dermatoses (PPDs) are chronic skin disorders characterized by purpura due to extravasation of blood from capillaries; the resulting hemosiderin deposition leads to pigmentation.⁷ There are various forms of PPD, which are classified into groups based on clinical appearance including Schamberg disease, purpura annularis telangiectodes of Majocchi, pigmented purpuric lichenoid dermatosis of Gougerot and Blum, lichen aureus, and others including eczematid and itching variants, which some consider to be distinct entities. Purpura annularis telangiectodes of Majocchi is the specific PPD that should be included in the clinical differential for PCFCL because it presents as annular patches with telangiectasias. Histologically, PPDs are characterized by a CD4⁺ lymphocytic infiltrate in the upper dermis with extravasated red blood cells and the presence of hemosiderin mostly within macrophages and a lack of true vasculitis. Clonality of the T cells has been shown, and there is some evidence that PPD may overlap with mycosis fungoides. However, this overlap mainly has been seen in patients with widespread lesions and would not apply to this case. In general, patients with PPD can be reassured of the benign process. In cases of widespread PPD, patients should be followed clinically to assess for progression to mycosis fungoides, though the likelihood is low.⁷  

Our patient underwent a full staging workup, which confirmed the diagnosis of PCFCL. He was treated with radiation to the forehead that resulted in clearance of the lesion. Approximately 2 years after the initial diagnosis, the patient was alive and well with no evidence of recurrence of PCFCL. 

In conclusion, it is imperative to identify unusual, macular, vascular-appearing patches, especially on the head and neck in older individuals. Because the clinical presentations of PCFCL, angiosarcoma, rosacea, MCC, and PPD can overlap with one another as well as with other entities, it is necessary to have a high level of suspicion and low threshold to biopsy these types of lesions, as outcomes can be drastically different.