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Histologic analysis of vaping-associated lung injury suggests chemical pneumonitis
Vaping-associated lung injury is likely a form of airway-centered chemical pneumonitis, not exogenous lipoid pneumonia, according to Yasmeen M. Butt, MD, of the University of Texas Southwestern Medical Center, Dallas, and associates.
Dr. Butt and associates performed a review of lung biopsies from 17 patients (13 men; median age, 35 years) with a history of vaping and either suspected or confirmed vaping-associated lung injury. All cases showed patterns of acute lung injury, including acute fibrinous pneumonitis, diffuse alveolar damage, or organizing pneumonia, the authors noted in a letter to the editor published in the New England Journal of Medicine.
While no histologic findings were specific, foamy macrophages and pneumocyte vacuolization were seen in all cases, the authors added. Pigmented macrophages were occasionally present but not dominant, neutrophils were often prominent, eosinophils were rare, and granulomas were not seen. Two patients eventually died, despite treatment with glucocorticoids and maximum supportive care.
“None of our cases showed histologic evidence of exogenous lipoid pneumonia and no radiologic evidence thereof has been found; this calls into question the diagnostic utility of identifying lipid-laden macrophages or performing oil red O staining on bronchioloalveolar lavage fluid as a marker of vaping-associated lung injury, as has been proposed,” Dr. Butt and associates wrote.
No conflicts of interest were reported.
SOURCE: Butt YM et al. N Engl J Med. 2019 Oct 2. doi: 10.1056/NEJMc1913069.
Vaping-associated lung injury is likely a form of airway-centered chemical pneumonitis, not exogenous lipoid pneumonia, according to Yasmeen M. Butt, MD, of the University of Texas Southwestern Medical Center, Dallas, and associates.
Dr. Butt and associates performed a review of lung biopsies from 17 patients (13 men; median age, 35 years) with a history of vaping and either suspected or confirmed vaping-associated lung injury. All cases showed patterns of acute lung injury, including acute fibrinous pneumonitis, diffuse alveolar damage, or organizing pneumonia, the authors noted in a letter to the editor published in the New England Journal of Medicine.
While no histologic findings were specific, foamy macrophages and pneumocyte vacuolization were seen in all cases, the authors added. Pigmented macrophages were occasionally present but not dominant, neutrophils were often prominent, eosinophils were rare, and granulomas were not seen. Two patients eventually died, despite treatment with glucocorticoids and maximum supportive care.
“None of our cases showed histologic evidence of exogenous lipoid pneumonia and no radiologic evidence thereof has been found; this calls into question the diagnostic utility of identifying lipid-laden macrophages or performing oil red O staining on bronchioloalveolar lavage fluid as a marker of vaping-associated lung injury, as has been proposed,” Dr. Butt and associates wrote.
No conflicts of interest were reported.
SOURCE: Butt YM et al. N Engl J Med. 2019 Oct 2. doi: 10.1056/NEJMc1913069.
Vaping-associated lung injury is likely a form of airway-centered chemical pneumonitis, not exogenous lipoid pneumonia, according to Yasmeen M. Butt, MD, of the University of Texas Southwestern Medical Center, Dallas, and associates.
Dr. Butt and associates performed a review of lung biopsies from 17 patients (13 men; median age, 35 years) with a history of vaping and either suspected or confirmed vaping-associated lung injury. All cases showed patterns of acute lung injury, including acute fibrinous pneumonitis, diffuse alveolar damage, or organizing pneumonia, the authors noted in a letter to the editor published in the New England Journal of Medicine.
While no histologic findings were specific, foamy macrophages and pneumocyte vacuolization were seen in all cases, the authors added. Pigmented macrophages were occasionally present but not dominant, neutrophils were often prominent, eosinophils were rare, and granulomas were not seen. Two patients eventually died, despite treatment with glucocorticoids and maximum supportive care.
“None of our cases showed histologic evidence of exogenous lipoid pneumonia and no radiologic evidence thereof has been found; this calls into question the diagnostic utility of identifying lipid-laden macrophages or performing oil red O staining on bronchioloalveolar lavage fluid as a marker of vaping-associated lung injury, as has been proposed,” Dr. Butt and associates wrote.
No conflicts of interest were reported.
SOURCE: Butt YM et al. N Engl J Med. 2019 Oct 2. doi: 10.1056/NEJMc1913069.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Measles 2019: Most cases occurred in close-knit, undervaccinated communities
While 22 outbreaks were reported in 17 states during 2019, the majority of measles cases occurred in a pair of outbreaks that started in late 2018, one in New York City and the other in New York state. Theses two outbreaks, which occurred in underimmunized, close-knit communities, accounted for 934 (75%) of the 2019 total. An additional six outbreaks in similar communities accounted for nearly half of the remaining reported cases.
The overall median patient age was 6 years, with 31% being children aged 1-4 years, 27% being school-age children aged 5-17 years, and 29% were adults aged at least 18 years. However, when excluding the New York City (NYC) and New York state outbreaks, the median patient age was 19 years. Outbreak length also differed significantly between the NYC and New York state outbreaks, compared with all other outbreaks; the NYC outbreak lasted for 9.5 months, involving 702 patients from start to finish, the New York state outbreak lasted for 10.5 months and involved 412 cases.
The rate of patients who were either unvaccinated or had unknown vaccination status was similar in the New York outbreaks and in the other U.S. outbreaks, ranging from 87% to 91%. A total of 119 patients were hospitalized, 20% of whom were younger than 1 year; no deaths were reported. A total of 81 cases were internationally imported; the rate of patients who were unvaccinated or had unknown status in this group was 90%.
While most outbreaks in 2019 were similar to those previously seen, the outbreaks in NYC and New York state were more sustained for three reasons, the CDC investigators said: pockets of low vaccination coverage and variable vaccine acceptance, relatively high population density and closed social nature of the community, and repeated importations of measles cases among unvaccinated persons traveling internationally and returning to or visiting the affected communities.
“Public health authorities need to identify pockets of undervaccinated persons to prevent these outbreaks, which require substantial resources to control. A preventive strategy to build vaccine confidence is important, especially one that uses culturally appropriate communication strategies to offset misinformation and disseminate accurate information about the safety and importance of vaccination in advance of outbreaks,” the CDC investigators concluded.
The CDC investigators reported that they had no conflicts of interest.
[email protected]
SOURCE: Patel M et al. MMWR Morb Mortal Wkly Rep. 2019 Oct 4. doi: 10.15585/mmwr.mm6840e2.
While 22 outbreaks were reported in 17 states during 2019, the majority of measles cases occurred in a pair of outbreaks that started in late 2018, one in New York City and the other in New York state. Theses two outbreaks, which occurred in underimmunized, close-knit communities, accounted for 934 (75%) of the 2019 total. An additional six outbreaks in similar communities accounted for nearly half of the remaining reported cases.
The overall median patient age was 6 years, with 31% being children aged 1-4 years, 27% being school-age children aged 5-17 years, and 29% were adults aged at least 18 years. However, when excluding the New York City (NYC) and New York state outbreaks, the median patient age was 19 years. Outbreak length also differed significantly between the NYC and New York state outbreaks, compared with all other outbreaks; the NYC outbreak lasted for 9.5 months, involving 702 patients from start to finish, the New York state outbreak lasted for 10.5 months and involved 412 cases.
The rate of patients who were either unvaccinated or had unknown vaccination status was similar in the New York outbreaks and in the other U.S. outbreaks, ranging from 87% to 91%. A total of 119 patients were hospitalized, 20% of whom were younger than 1 year; no deaths were reported. A total of 81 cases were internationally imported; the rate of patients who were unvaccinated or had unknown status in this group was 90%.
While most outbreaks in 2019 were similar to those previously seen, the outbreaks in NYC and New York state were more sustained for three reasons, the CDC investigators said: pockets of low vaccination coverage and variable vaccine acceptance, relatively high population density and closed social nature of the community, and repeated importations of measles cases among unvaccinated persons traveling internationally and returning to or visiting the affected communities.
“Public health authorities need to identify pockets of undervaccinated persons to prevent these outbreaks, which require substantial resources to control. A preventive strategy to build vaccine confidence is important, especially one that uses culturally appropriate communication strategies to offset misinformation and disseminate accurate information about the safety and importance of vaccination in advance of outbreaks,” the CDC investigators concluded.
The CDC investigators reported that they had no conflicts of interest.
[email protected]
SOURCE: Patel M et al. MMWR Morb Mortal Wkly Rep. 2019 Oct 4. doi: 10.15585/mmwr.mm6840e2.
While 22 outbreaks were reported in 17 states during 2019, the majority of measles cases occurred in a pair of outbreaks that started in late 2018, one in New York City and the other in New York state. Theses two outbreaks, which occurred in underimmunized, close-knit communities, accounted for 934 (75%) of the 2019 total. An additional six outbreaks in similar communities accounted for nearly half of the remaining reported cases.
The overall median patient age was 6 years, with 31% being children aged 1-4 years, 27% being school-age children aged 5-17 years, and 29% were adults aged at least 18 years. However, when excluding the New York City (NYC) and New York state outbreaks, the median patient age was 19 years. Outbreak length also differed significantly between the NYC and New York state outbreaks, compared with all other outbreaks; the NYC outbreak lasted for 9.5 months, involving 702 patients from start to finish, the New York state outbreak lasted for 10.5 months and involved 412 cases.
The rate of patients who were either unvaccinated or had unknown vaccination status was similar in the New York outbreaks and in the other U.S. outbreaks, ranging from 87% to 91%. A total of 119 patients were hospitalized, 20% of whom were younger than 1 year; no deaths were reported. A total of 81 cases were internationally imported; the rate of patients who were unvaccinated or had unknown status in this group was 90%.
While most outbreaks in 2019 were similar to those previously seen, the outbreaks in NYC and New York state were more sustained for three reasons, the CDC investigators said: pockets of low vaccination coverage and variable vaccine acceptance, relatively high population density and closed social nature of the community, and repeated importations of measles cases among unvaccinated persons traveling internationally and returning to or visiting the affected communities.
“Public health authorities need to identify pockets of undervaccinated persons to prevent these outbreaks, which require substantial resources to control. A preventive strategy to build vaccine confidence is important, especially one that uses culturally appropriate communication strategies to offset misinformation and disseminate accurate information about the safety and importance of vaccination in advance of outbreaks,” the CDC investigators concluded.
The CDC investigators reported that they had no conflicts of interest.
[email protected]
SOURCE: Patel M et al. MMWR Morb Mortal Wkly Rep. 2019 Oct 4. doi: 10.15585/mmwr.mm6840e2.
FROM THE MMWR
Oral drug cut viral respiratory tract infections in elderly
WASHINGTON – An investigational, oral, small molecule designed to boost innate antiviral immunity safely cut the incidence of various viral respiratory infections in elderly people during a winter season by nearly a third when administered once daily in a placebo-controlled, multicenter, phase 2 study of 952 patients. Based on these and other findings the drug, RTB101, is now undergoing testing in a phase 3 study, Joan Mannick, MD, said at an annual scientific meeting on infectious diseases.
At a dosage of 10 mg once daily, RTB101 was “well tolerated, upregulated innate antiviral gene expression, and reduced the incidence” of laboratory-confirmed respiratory tract infections caused by several different viruses, said Dr. Mannick, who disclosed that she is a cofounder and chief medical officer of resTORbio, a Boston-based company that’s developing the drug.
During 16 weeks of treatment during the winter virus season, once-daily dosing led to cuts in the rates of respiratory infections compared with placebo by rhinovirus and enterovirus, respiratory syncytial virus, coronavirus, influenza virus, metapneuomovirus, and parainfluenza virus, especially in patients whom the results identified as having the best drug responses: those who were at least 85 years old, and those who were at least 65 years old and also had asthma. Enrolled patients who were at least 65 years old and had other risk factors – current smoking, chronic obstructive pulmonary disease, or diabetes – had notably less robust responses to treatment, and the phase 3 study is not enrolling elderly people who currently smoke or have chronic obstructive pulmonary disease, Dr. Mannick said in an interview.
RTB101 inhibits the active site of the “mechanistic target of rapamycin” (mTOR) protein, the key player of the TORC1 protein complex that appears to downregulate innate antiviral immunity when active. Hence inhibiting mTOR and TORC1 activity should boost innate antiviral immunity. Once-daily dosing with 10 mg of RTB101 appears to mimic the normal daily cycle of high and low levels of TORC1 activity seen in younger adults but which is missing the elderly who generally have persistently elevated levels of TORC1 activity, Dr. Mannick explained.
The study she reported enrolled a total of 952 people at any of 10 sites in the Southern Hemisphere or 17 Northern Hemisphere study sites. The researchers randomized patients to receive either RTB101 or placebo at either of two once-daily dosages or either of two twice-daily regimens. The best drug performance was among the 356 patients treated with 10 mg once daily or placebo. Those who received the active drug at this level had a 19% incidence of any laboratory-confirmed respiratory tract infection, while those who received placebo had a 28% incidence, a 30.6% relative risk reduction with RTB101 treatment that was statistically significant.
The actively-treated patients showed upregulation for 19 of 20 “antiviral” genes assessed in the study compared with upregulation of just five of these genes in the those who received placebo. Two post hoc analyses showed that the people who received 10 mg once daily had about half the rate of all-cause hospitalizations compared with those on placebo, and among those who had respiratory infections treated patients had alleviation of their moderate or severe symptoms in about half the time compared with patients on placebo.
The 10-mg daily dosage of RTB101 is less than 1% of the maximum-tolerated dose in people, and the safety data collected in the current study showed adverse events occurring at similar rates in the patients who received the active drug and those who got placebo. Discontinuations because of adverse events occurred in 5% of people who received RTB101 and in 6% of those on placebo.
The researchers are planning to run a cost-effectiveness study to see whether the observed prevention of respiratory tract infections and their consequences can offset the cost of taking RTB101 daily for 16 weeks, Dr. Mannick said.
WASHINGTON – An investigational, oral, small molecule designed to boost innate antiviral immunity safely cut the incidence of various viral respiratory infections in elderly people during a winter season by nearly a third when administered once daily in a placebo-controlled, multicenter, phase 2 study of 952 patients. Based on these and other findings the drug, RTB101, is now undergoing testing in a phase 3 study, Joan Mannick, MD, said at an annual scientific meeting on infectious diseases.
At a dosage of 10 mg once daily, RTB101 was “well tolerated, upregulated innate antiviral gene expression, and reduced the incidence” of laboratory-confirmed respiratory tract infections caused by several different viruses, said Dr. Mannick, who disclosed that she is a cofounder and chief medical officer of resTORbio, a Boston-based company that’s developing the drug.
During 16 weeks of treatment during the winter virus season, once-daily dosing led to cuts in the rates of respiratory infections compared with placebo by rhinovirus and enterovirus, respiratory syncytial virus, coronavirus, influenza virus, metapneuomovirus, and parainfluenza virus, especially in patients whom the results identified as having the best drug responses: those who were at least 85 years old, and those who were at least 65 years old and also had asthma. Enrolled patients who were at least 65 years old and had other risk factors – current smoking, chronic obstructive pulmonary disease, or diabetes – had notably less robust responses to treatment, and the phase 3 study is not enrolling elderly people who currently smoke or have chronic obstructive pulmonary disease, Dr. Mannick said in an interview.
RTB101 inhibits the active site of the “mechanistic target of rapamycin” (mTOR) protein, the key player of the TORC1 protein complex that appears to downregulate innate antiviral immunity when active. Hence inhibiting mTOR and TORC1 activity should boost innate antiviral immunity. Once-daily dosing with 10 mg of RTB101 appears to mimic the normal daily cycle of high and low levels of TORC1 activity seen in younger adults but which is missing the elderly who generally have persistently elevated levels of TORC1 activity, Dr. Mannick explained.
The study she reported enrolled a total of 952 people at any of 10 sites in the Southern Hemisphere or 17 Northern Hemisphere study sites. The researchers randomized patients to receive either RTB101 or placebo at either of two once-daily dosages or either of two twice-daily regimens. The best drug performance was among the 356 patients treated with 10 mg once daily or placebo. Those who received the active drug at this level had a 19% incidence of any laboratory-confirmed respiratory tract infection, while those who received placebo had a 28% incidence, a 30.6% relative risk reduction with RTB101 treatment that was statistically significant.
The actively-treated patients showed upregulation for 19 of 20 “antiviral” genes assessed in the study compared with upregulation of just five of these genes in the those who received placebo. Two post hoc analyses showed that the people who received 10 mg once daily had about half the rate of all-cause hospitalizations compared with those on placebo, and among those who had respiratory infections treated patients had alleviation of their moderate or severe symptoms in about half the time compared with patients on placebo.
The 10-mg daily dosage of RTB101 is less than 1% of the maximum-tolerated dose in people, and the safety data collected in the current study showed adverse events occurring at similar rates in the patients who received the active drug and those who got placebo. Discontinuations because of adverse events occurred in 5% of people who received RTB101 and in 6% of those on placebo.
The researchers are planning to run a cost-effectiveness study to see whether the observed prevention of respiratory tract infections and their consequences can offset the cost of taking RTB101 daily for 16 weeks, Dr. Mannick said.
WASHINGTON – An investigational, oral, small molecule designed to boost innate antiviral immunity safely cut the incidence of various viral respiratory infections in elderly people during a winter season by nearly a third when administered once daily in a placebo-controlled, multicenter, phase 2 study of 952 patients. Based on these and other findings the drug, RTB101, is now undergoing testing in a phase 3 study, Joan Mannick, MD, said at an annual scientific meeting on infectious diseases.
At a dosage of 10 mg once daily, RTB101 was “well tolerated, upregulated innate antiviral gene expression, and reduced the incidence” of laboratory-confirmed respiratory tract infections caused by several different viruses, said Dr. Mannick, who disclosed that she is a cofounder and chief medical officer of resTORbio, a Boston-based company that’s developing the drug.
During 16 weeks of treatment during the winter virus season, once-daily dosing led to cuts in the rates of respiratory infections compared with placebo by rhinovirus and enterovirus, respiratory syncytial virus, coronavirus, influenza virus, metapneuomovirus, and parainfluenza virus, especially in patients whom the results identified as having the best drug responses: those who were at least 85 years old, and those who were at least 65 years old and also had asthma. Enrolled patients who were at least 65 years old and had other risk factors – current smoking, chronic obstructive pulmonary disease, or diabetes – had notably less robust responses to treatment, and the phase 3 study is not enrolling elderly people who currently smoke or have chronic obstructive pulmonary disease, Dr. Mannick said in an interview.
RTB101 inhibits the active site of the “mechanistic target of rapamycin” (mTOR) protein, the key player of the TORC1 protein complex that appears to downregulate innate antiviral immunity when active. Hence inhibiting mTOR and TORC1 activity should boost innate antiviral immunity. Once-daily dosing with 10 mg of RTB101 appears to mimic the normal daily cycle of high and low levels of TORC1 activity seen in younger adults but which is missing the elderly who generally have persistently elevated levels of TORC1 activity, Dr. Mannick explained.
The study she reported enrolled a total of 952 people at any of 10 sites in the Southern Hemisphere or 17 Northern Hemisphere study sites. The researchers randomized patients to receive either RTB101 or placebo at either of two once-daily dosages or either of two twice-daily regimens. The best drug performance was among the 356 patients treated with 10 mg once daily or placebo. Those who received the active drug at this level had a 19% incidence of any laboratory-confirmed respiratory tract infection, while those who received placebo had a 28% incidence, a 30.6% relative risk reduction with RTB101 treatment that was statistically significant.
The actively-treated patients showed upregulation for 19 of 20 “antiviral” genes assessed in the study compared with upregulation of just five of these genes in the those who received placebo. Two post hoc analyses showed that the people who received 10 mg once daily had about half the rate of all-cause hospitalizations compared with those on placebo, and among those who had respiratory infections treated patients had alleviation of their moderate or severe symptoms in about half the time compared with patients on placebo.
The 10-mg daily dosage of RTB101 is less than 1% of the maximum-tolerated dose in people, and the safety data collected in the current study showed adverse events occurring at similar rates in the patients who received the active drug and those who got placebo. Discontinuations because of adverse events occurred in 5% of people who received RTB101 and in 6% of those on placebo.
The researchers are planning to run a cost-effectiveness study to see whether the observed prevention of respiratory tract infections and their consequences can offset the cost of taking RTB101 daily for 16 weeks, Dr. Mannick said.
REPORTING FROM IDWEEK 2019
Coming soon!
Check back later this month for top news from the 2019 AANEM Annual Meeting in Austin.
Check back later this month for top news from the 2019 AANEM Annual Meeting in Austin.
Check back later this month for top news from the 2019 AANEM Annual Meeting in Austin.
Buprenorphine merits more attention for treatment of opioid use disorder
SAN DIEGO – Prescribing buprenorphine for the treatment of opioid use disorder requires strict discernment on the part of clinicians, Arwen Podesta, MD, said at the annual Psych Congress.
She encouraged clinicians to be prepared for a visit from the Drug Enforcement Administration, understand the unique properties of buprenorphine, and make sure that patients grasp the importance of sublingual administration.
Research shows that only 5% of physicians are allowed to prescribe buprenorphine – an opioid – by way of a DEA waiver, Dr. Podesta said. About half do not prescribe the drug. Barriers to prescribing buprenorphine include factors such as low reimbursement and untrained support staff, said Dr. Podesta, a board-certified psychiatrist who subspecializes in addiction medicine and practices in New Orleans.
But she noted that the Substance Abuse and Mental Health Services Administration has recommended that medication-assisted therapy (MAT) – methadone, buprenorphine, and naltrexone – be considered in all patients with opioid use disorder. The drugs are safe and effective when used correctly, the federal agency has said.
Remember, Dr. Podesta said, that “patients taking MAT are considered to be in recovery.” In the big picture, she added, “we have to improve access to care because we have so many people who don’t have access to treatment.”
Getting permission from the DEA to prescribe buprenorphine – a schedule III controlled substance – comes with a price, Dr. Podesta said. “We have special scrutiny from the DEA,” she said. They come in and want to see your records. It sounds very punitive, although it’s their jobs.”
The best approach is to document that you know what you’re doing, she said. “It’s your job to educate them about why you’re using buprenorphine and produce the records to show that.”
Being aware of buprenorphine’s unique properties is important, she said. The drug is safer on the overdose front than are other opioids, Dr. Podesta said, but it can be very dangerous in patients without opioid tolerance. According to the DEA, as an analgesic, buprenorphine is 20-30 times more potent than morphine. Also, like morphine, patients who take buprenorphine are likely to experience euphoria, papillary restriction, and respiratory depression and sedation.
The buprenorphine/naloxone formulation is preferred to treat opioid use disorder, she noted.
The reason that naloxone, which treats opioid overdoses, is part of the drug combo is because as an add-on, it reduces the risk that buprenorphine will be crushed and snorted for an opioid high, she said. Those who take the combo drug via that method could end up with sudden and nasty withdrawal symptoms.
When the drug combo is administered sublingually, the idea is that the “good stuff” (buprenorphine) is absorbed in the mouth, while the “bad stuff” (naloxone) is harmlessly absorbed in the gut, Dr. Podesta said. This happens because the drugs are absorbed differently.
But patients can mistakenly trigger symptoms of withdrawal if, for example, they put the combo drug on their tongue and then go to sleep. “That’s a peril,” she said, and it’s important to make sure patients know what to do – and what not to do.
Dr. Podesta emphasized the importance of choosing language related to patients with addictions carefully and respectfully.
“We have stigma,” she said. “We have been saying that patients are ‘dirty’ or ‘clean,’ and if they’re ‘clean,’ they’re the opposite of ‘dirty.’
She also suggested that clinicians drop the use of the word “contract” to describe treatment agreements between patients and clinicians. “Call it an ‘agreement,’ ” she said. “It seems more mutual and less punitive or risky for the patient to sign, especially when they’re in a precarious comfort zone.”
And consider that even the words “substance abuse” can be misleading, she said. “Many [patients] are taking the medications that the doctor prescribed and following instructions to the letter.”
Dr. Podesta disclosed consulting with Kaleo, Pear Therapeutics, and JayMac, and serving on the speakers bureau of Alkermes, Orexo, and US WorldMeds. She is the author of “Hooked: A Concise Guide to the Underlying Mechanics of Addiction and Treatment for Patients, Families, and Providers” (Dog Ear Publishing, 2016).
SAN DIEGO – Prescribing buprenorphine for the treatment of opioid use disorder requires strict discernment on the part of clinicians, Arwen Podesta, MD, said at the annual Psych Congress.
She encouraged clinicians to be prepared for a visit from the Drug Enforcement Administration, understand the unique properties of buprenorphine, and make sure that patients grasp the importance of sublingual administration.
Research shows that only 5% of physicians are allowed to prescribe buprenorphine – an opioid – by way of a DEA waiver, Dr. Podesta said. About half do not prescribe the drug. Barriers to prescribing buprenorphine include factors such as low reimbursement and untrained support staff, said Dr. Podesta, a board-certified psychiatrist who subspecializes in addiction medicine and practices in New Orleans.
But she noted that the Substance Abuse and Mental Health Services Administration has recommended that medication-assisted therapy (MAT) – methadone, buprenorphine, and naltrexone – be considered in all patients with opioid use disorder. The drugs are safe and effective when used correctly, the federal agency has said.
Remember, Dr. Podesta said, that “patients taking MAT are considered to be in recovery.” In the big picture, she added, “we have to improve access to care because we have so many people who don’t have access to treatment.”
Getting permission from the DEA to prescribe buprenorphine – a schedule III controlled substance – comes with a price, Dr. Podesta said. “We have special scrutiny from the DEA,” she said. They come in and want to see your records. It sounds very punitive, although it’s their jobs.”
The best approach is to document that you know what you’re doing, she said. “It’s your job to educate them about why you’re using buprenorphine and produce the records to show that.”
Being aware of buprenorphine’s unique properties is important, she said. The drug is safer on the overdose front than are other opioids, Dr. Podesta said, but it can be very dangerous in patients without opioid tolerance. According to the DEA, as an analgesic, buprenorphine is 20-30 times more potent than morphine. Also, like morphine, patients who take buprenorphine are likely to experience euphoria, papillary restriction, and respiratory depression and sedation.
The buprenorphine/naloxone formulation is preferred to treat opioid use disorder, she noted.
The reason that naloxone, which treats opioid overdoses, is part of the drug combo is because as an add-on, it reduces the risk that buprenorphine will be crushed and snorted for an opioid high, she said. Those who take the combo drug via that method could end up with sudden and nasty withdrawal symptoms.
When the drug combo is administered sublingually, the idea is that the “good stuff” (buprenorphine) is absorbed in the mouth, while the “bad stuff” (naloxone) is harmlessly absorbed in the gut, Dr. Podesta said. This happens because the drugs are absorbed differently.
But patients can mistakenly trigger symptoms of withdrawal if, for example, they put the combo drug on their tongue and then go to sleep. “That’s a peril,” she said, and it’s important to make sure patients know what to do – and what not to do.
Dr. Podesta emphasized the importance of choosing language related to patients with addictions carefully and respectfully.
“We have stigma,” she said. “We have been saying that patients are ‘dirty’ or ‘clean,’ and if they’re ‘clean,’ they’re the opposite of ‘dirty.’
She also suggested that clinicians drop the use of the word “contract” to describe treatment agreements between patients and clinicians. “Call it an ‘agreement,’ ” she said. “It seems more mutual and less punitive or risky for the patient to sign, especially when they’re in a precarious comfort zone.”
And consider that even the words “substance abuse” can be misleading, she said. “Many [patients] are taking the medications that the doctor prescribed and following instructions to the letter.”
Dr. Podesta disclosed consulting with Kaleo, Pear Therapeutics, and JayMac, and serving on the speakers bureau of Alkermes, Orexo, and US WorldMeds. She is the author of “Hooked: A Concise Guide to the Underlying Mechanics of Addiction and Treatment for Patients, Families, and Providers” (Dog Ear Publishing, 2016).
SAN DIEGO – Prescribing buprenorphine for the treatment of opioid use disorder requires strict discernment on the part of clinicians, Arwen Podesta, MD, said at the annual Psych Congress.
She encouraged clinicians to be prepared for a visit from the Drug Enforcement Administration, understand the unique properties of buprenorphine, and make sure that patients grasp the importance of sublingual administration.
Research shows that only 5% of physicians are allowed to prescribe buprenorphine – an opioid – by way of a DEA waiver, Dr. Podesta said. About half do not prescribe the drug. Barriers to prescribing buprenorphine include factors such as low reimbursement and untrained support staff, said Dr. Podesta, a board-certified psychiatrist who subspecializes in addiction medicine and practices in New Orleans.
But she noted that the Substance Abuse and Mental Health Services Administration has recommended that medication-assisted therapy (MAT) – methadone, buprenorphine, and naltrexone – be considered in all patients with opioid use disorder. The drugs are safe and effective when used correctly, the federal agency has said.
Remember, Dr. Podesta said, that “patients taking MAT are considered to be in recovery.” In the big picture, she added, “we have to improve access to care because we have so many people who don’t have access to treatment.”
Getting permission from the DEA to prescribe buprenorphine – a schedule III controlled substance – comes with a price, Dr. Podesta said. “We have special scrutiny from the DEA,” she said. They come in and want to see your records. It sounds very punitive, although it’s their jobs.”
The best approach is to document that you know what you’re doing, she said. “It’s your job to educate them about why you’re using buprenorphine and produce the records to show that.”
Being aware of buprenorphine’s unique properties is important, she said. The drug is safer on the overdose front than are other opioids, Dr. Podesta said, but it can be very dangerous in patients without opioid tolerance. According to the DEA, as an analgesic, buprenorphine is 20-30 times more potent than morphine. Also, like morphine, patients who take buprenorphine are likely to experience euphoria, papillary restriction, and respiratory depression and sedation.
The buprenorphine/naloxone formulation is preferred to treat opioid use disorder, she noted.
The reason that naloxone, which treats opioid overdoses, is part of the drug combo is because as an add-on, it reduces the risk that buprenorphine will be crushed and snorted for an opioid high, she said. Those who take the combo drug via that method could end up with sudden and nasty withdrawal symptoms.
When the drug combo is administered sublingually, the idea is that the “good stuff” (buprenorphine) is absorbed in the mouth, while the “bad stuff” (naloxone) is harmlessly absorbed in the gut, Dr. Podesta said. This happens because the drugs are absorbed differently.
But patients can mistakenly trigger symptoms of withdrawal if, for example, they put the combo drug on their tongue and then go to sleep. “That’s a peril,” she said, and it’s important to make sure patients know what to do – and what not to do.
Dr. Podesta emphasized the importance of choosing language related to patients with addictions carefully and respectfully.
“We have stigma,” she said. “We have been saying that patients are ‘dirty’ or ‘clean,’ and if they’re ‘clean,’ they’re the opposite of ‘dirty.’
She also suggested that clinicians drop the use of the word “contract” to describe treatment agreements between patients and clinicians. “Call it an ‘agreement,’ ” she said. “It seems more mutual and less punitive or risky for the patient to sign, especially when they’re in a precarious comfort zone.”
And consider that even the words “substance abuse” can be misleading, she said. “Many [patients] are taking the medications that the doctor prescribed and following instructions to the letter.”
Dr. Podesta disclosed consulting with Kaleo, Pear Therapeutics, and JayMac, and serving on the speakers bureau of Alkermes, Orexo, and US WorldMeds. She is the author of “Hooked: A Concise Guide to the Underlying Mechanics of Addiction and Treatment for Patients, Families, and Providers” (Dog Ear Publishing, 2016).
REPORTING FROM PSYCH CONGRESS 2019
Continuous NSAID use for ankylosing spondylitis may raise hypertension risk
Continuous use of NSAIDs could increase the risk of incident hypertension among patients with ankylosing spondylitis (AS), according to findings from a recent prospective study.
Against expectations, data also suggested that tumor necrosis factor inhibitor (TNFi) therapy could increase blood pressure, although this finding was not significant across all methods of analysis, reported lead author Jean W. Liew, MD, of the University of Washington, Seattle, and colleagues.
The investigators noted that patients with AS already have a greater risk of cardiovascular disease than that of the general population, making any added risks that much more concerning.
“[T]he evidence for increased cardiovascular disease burden and cardiovascular risk in patients with inflammatory rheumatic diseases is well recognized,” the investigators wrote in Arthritis Care & Research. “Multiple population-based studies have demonstrated increased cardiovascular events and cardiovascular-related mortality in AS. There is a high prevalence of cardiovascular risk factors among individuals with AS, particularly hypertension.”
Exacerbation of this risk by NSAIDs has been previously studied with mixed results, according to the investigators. Meta-analyses have suggested that NSAIDs increase blood pressure in normotensive and hypertensive individuals, but some data point to a cardioprotective effect among those with AS, possibly as a consequence of dampened inflammation, and/or improved physical activity, which could lead to a secondary CV benefit. Still, the relationship between NSAIDs and CV risk was unclear, prompting the current study.
The investigators enrolled 1,282 patients with AS at five centers in the United States and Australia. Using a combination of clinical evaluations and self-reporting, enrollees were monitored at regular intervals. Disease activity was tracked with the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), while the Bath Ankylosing Spondylitis Functional Index (BASFI) was used for functional impairments. Patients were also checked for a variety of comorbidities such as hypertension, coronary artery disease, mental health conditions, and renal disorders. Medication data included type, dosage, frequency, duration, and number of missed doses.
Including only baseline normotensive patients with at least 1 year of follow-up, 628 participants were eligible for analysis, of whom 200 used NSAIDs continuously. After a median of 7 years follow-up, 129 out of 628 patients developed hypertension. This translated to a hazard ratio (HR) for incident hypertension of 1.12 (95% confidence interval, 1.04-1.20), compared with nonusers or those who took NSAIDs intermittently. This relationship did not differ across subgroups defined by age, disease activity, body mass index, or TNFi use. Multiple sensitivity analyses added support to the association between continuous NSAID use and hypertension.
“The association of NSAIDs and incident hypertension remains particularly concerning, as the early development of hypertension may portend a higher risk of premature CV events due to cumulative exposure,” the investigators wrote.
In contrast with NSAIDs, TNFi therapy was not associated with hypertension across all models; however, against expectations, two models of analysis pointed to an 8% increased risk.
“Although TNFi use did not reach statistical significance in the main model, the direction of association was opposite that hypothesized based on prior data, specifically that TNFi use reduces CV risk by suppressing chronic inflammation,” the investigators wrote.
Considering the present findings, and previous studies, which have reported conflicting associations between TNFi use and hypertension, the investigators suggested that more research is needed, and offered specific methods to approach the topic.
“The association of TNFi use and incident hypertension requires further clarification in future studies,” they wrote, “which may be done by applying a marginal structural modeling (MSM) framework and inverse probability of treatment weighting (IPTW) statistical analyses to account for the relationships between TNFi use, disease activity, and NSAID use.”
In their concluding remarks, the investigators further emphasized the current knowledge gap in this area.
“There is an unmet need to clarify how treatment choices, particularly the use of NSAIDs and TNFi, impact CV risk factors and CV events in AS,” they wrote. “Further studies are needed to focus on precision medicine and predicting risk and benefit for patients in whom continuous NSAIDs are being considered. These further studies can inform the revision of guidelines to address the management of CV risk factors and CV disease in AS and axial spondyloarthritis more broadly.”
The investigators reported funding from the National Institutes of Health, the Assessment of Spondyloarthritis International Society, the Spondylitis Association of America, and the Russel Engleman Rheumatology Research Center at the University of California, San Francisco. Some authors reported ties with Eli Lilly, Novartis, and other pharmaceutical companies..
SOURCE: Liew et al. Arthritis Care Res. 2019 Sep 17. doi: 10.1002/acr.24070.
Continuous use of NSAIDs could increase the risk of incident hypertension among patients with ankylosing spondylitis (AS), according to findings from a recent prospective study.
Against expectations, data also suggested that tumor necrosis factor inhibitor (TNFi) therapy could increase blood pressure, although this finding was not significant across all methods of analysis, reported lead author Jean W. Liew, MD, of the University of Washington, Seattle, and colleagues.
The investigators noted that patients with AS already have a greater risk of cardiovascular disease than that of the general population, making any added risks that much more concerning.
“[T]he evidence for increased cardiovascular disease burden and cardiovascular risk in patients with inflammatory rheumatic diseases is well recognized,” the investigators wrote in Arthritis Care & Research. “Multiple population-based studies have demonstrated increased cardiovascular events and cardiovascular-related mortality in AS. There is a high prevalence of cardiovascular risk factors among individuals with AS, particularly hypertension.”
Exacerbation of this risk by NSAIDs has been previously studied with mixed results, according to the investigators. Meta-analyses have suggested that NSAIDs increase blood pressure in normotensive and hypertensive individuals, but some data point to a cardioprotective effect among those with AS, possibly as a consequence of dampened inflammation, and/or improved physical activity, which could lead to a secondary CV benefit. Still, the relationship between NSAIDs and CV risk was unclear, prompting the current study.
The investigators enrolled 1,282 patients with AS at five centers in the United States and Australia. Using a combination of clinical evaluations and self-reporting, enrollees were monitored at regular intervals. Disease activity was tracked with the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), while the Bath Ankylosing Spondylitis Functional Index (BASFI) was used for functional impairments. Patients were also checked for a variety of comorbidities such as hypertension, coronary artery disease, mental health conditions, and renal disorders. Medication data included type, dosage, frequency, duration, and number of missed doses.
Including only baseline normotensive patients with at least 1 year of follow-up, 628 participants were eligible for analysis, of whom 200 used NSAIDs continuously. After a median of 7 years follow-up, 129 out of 628 patients developed hypertension. This translated to a hazard ratio (HR) for incident hypertension of 1.12 (95% confidence interval, 1.04-1.20), compared with nonusers or those who took NSAIDs intermittently. This relationship did not differ across subgroups defined by age, disease activity, body mass index, or TNFi use. Multiple sensitivity analyses added support to the association between continuous NSAID use and hypertension.
“The association of NSAIDs and incident hypertension remains particularly concerning, as the early development of hypertension may portend a higher risk of premature CV events due to cumulative exposure,” the investigators wrote.
In contrast with NSAIDs, TNFi therapy was not associated with hypertension across all models; however, against expectations, two models of analysis pointed to an 8% increased risk.
“Although TNFi use did not reach statistical significance in the main model, the direction of association was opposite that hypothesized based on prior data, specifically that TNFi use reduces CV risk by suppressing chronic inflammation,” the investigators wrote.
Considering the present findings, and previous studies, which have reported conflicting associations between TNFi use and hypertension, the investigators suggested that more research is needed, and offered specific methods to approach the topic.
“The association of TNFi use and incident hypertension requires further clarification in future studies,” they wrote, “which may be done by applying a marginal structural modeling (MSM) framework and inverse probability of treatment weighting (IPTW) statistical analyses to account for the relationships between TNFi use, disease activity, and NSAID use.”
In their concluding remarks, the investigators further emphasized the current knowledge gap in this area.
“There is an unmet need to clarify how treatment choices, particularly the use of NSAIDs and TNFi, impact CV risk factors and CV events in AS,” they wrote. “Further studies are needed to focus on precision medicine and predicting risk and benefit for patients in whom continuous NSAIDs are being considered. These further studies can inform the revision of guidelines to address the management of CV risk factors and CV disease in AS and axial spondyloarthritis more broadly.”
The investigators reported funding from the National Institutes of Health, the Assessment of Spondyloarthritis International Society, the Spondylitis Association of America, and the Russel Engleman Rheumatology Research Center at the University of California, San Francisco. Some authors reported ties with Eli Lilly, Novartis, and other pharmaceutical companies..
SOURCE: Liew et al. Arthritis Care Res. 2019 Sep 17. doi: 10.1002/acr.24070.
Continuous use of NSAIDs could increase the risk of incident hypertension among patients with ankylosing spondylitis (AS), according to findings from a recent prospective study.
Against expectations, data also suggested that tumor necrosis factor inhibitor (TNFi) therapy could increase blood pressure, although this finding was not significant across all methods of analysis, reported lead author Jean W. Liew, MD, of the University of Washington, Seattle, and colleagues.
The investigators noted that patients with AS already have a greater risk of cardiovascular disease than that of the general population, making any added risks that much more concerning.
“[T]he evidence for increased cardiovascular disease burden and cardiovascular risk in patients with inflammatory rheumatic diseases is well recognized,” the investigators wrote in Arthritis Care & Research. “Multiple population-based studies have demonstrated increased cardiovascular events and cardiovascular-related mortality in AS. There is a high prevalence of cardiovascular risk factors among individuals with AS, particularly hypertension.”
Exacerbation of this risk by NSAIDs has been previously studied with mixed results, according to the investigators. Meta-analyses have suggested that NSAIDs increase blood pressure in normotensive and hypertensive individuals, but some data point to a cardioprotective effect among those with AS, possibly as a consequence of dampened inflammation, and/or improved physical activity, which could lead to a secondary CV benefit. Still, the relationship between NSAIDs and CV risk was unclear, prompting the current study.
The investigators enrolled 1,282 patients with AS at five centers in the United States and Australia. Using a combination of clinical evaluations and self-reporting, enrollees were monitored at regular intervals. Disease activity was tracked with the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), while the Bath Ankylosing Spondylitis Functional Index (BASFI) was used for functional impairments. Patients were also checked for a variety of comorbidities such as hypertension, coronary artery disease, mental health conditions, and renal disorders. Medication data included type, dosage, frequency, duration, and number of missed doses.
Including only baseline normotensive patients with at least 1 year of follow-up, 628 participants were eligible for analysis, of whom 200 used NSAIDs continuously. After a median of 7 years follow-up, 129 out of 628 patients developed hypertension. This translated to a hazard ratio (HR) for incident hypertension of 1.12 (95% confidence interval, 1.04-1.20), compared with nonusers or those who took NSAIDs intermittently. This relationship did not differ across subgroups defined by age, disease activity, body mass index, or TNFi use. Multiple sensitivity analyses added support to the association between continuous NSAID use and hypertension.
“The association of NSAIDs and incident hypertension remains particularly concerning, as the early development of hypertension may portend a higher risk of premature CV events due to cumulative exposure,” the investigators wrote.
In contrast with NSAIDs, TNFi therapy was not associated with hypertension across all models; however, against expectations, two models of analysis pointed to an 8% increased risk.
“Although TNFi use did not reach statistical significance in the main model, the direction of association was opposite that hypothesized based on prior data, specifically that TNFi use reduces CV risk by suppressing chronic inflammation,” the investigators wrote.
Considering the present findings, and previous studies, which have reported conflicting associations between TNFi use and hypertension, the investigators suggested that more research is needed, and offered specific methods to approach the topic.
“The association of TNFi use and incident hypertension requires further clarification in future studies,” they wrote, “which may be done by applying a marginal structural modeling (MSM) framework and inverse probability of treatment weighting (IPTW) statistical analyses to account for the relationships between TNFi use, disease activity, and NSAID use.”
In their concluding remarks, the investigators further emphasized the current knowledge gap in this area.
“There is an unmet need to clarify how treatment choices, particularly the use of NSAIDs and TNFi, impact CV risk factors and CV events in AS,” they wrote. “Further studies are needed to focus on precision medicine and predicting risk and benefit for patients in whom continuous NSAIDs are being considered. These further studies can inform the revision of guidelines to address the management of CV risk factors and CV disease in AS and axial spondyloarthritis more broadly.”
The investigators reported funding from the National Institutes of Health, the Assessment of Spondyloarthritis International Society, the Spondylitis Association of America, and the Russel Engleman Rheumatology Research Center at the University of California, San Francisco. Some authors reported ties with Eli Lilly, Novartis, and other pharmaceutical companies..
SOURCE: Liew et al. Arthritis Care Res. 2019 Sep 17. doi: 10.1002/acr.24070.
FROM ARTHRITIS CARE & RESEARCH
Poll: Do you think that the electronic medical record has improved patient care?
[polldaddy:10424906]
[polldaddy:10424906]
[polldaddy:10424906]
Multigene testing for all patients with breast cancer may be cost-effective, life-saving
High-risk multigene testing for all patients with breast cancer may be a cost-effective way to reduce rates of breast cancer and ovarian cancer, according to investigators.
A microsimulation modeling study suggested that moving from standard BRCA testing based on clinical criteria or family history to widespread adoption of multigene testing could potentially save more than 2,400 lives per year in the United States, reported lead author Li Sun, MSc, of the London School of Hygiene & Tropical Medicine, and colleagues.
“Moving toward unselected BC testing may give an impetus for prevention in unaffected family members along with clinical implications for the patient with BC. Pathogenic variant carriers with newly diagnosed BC can opt for bilateral mastectomy rather than breast conservation at initial BC surgery,” the investigators wrote in JAMA Oncology. They noted that, presently, only 20%-30% of eligible patients are actually tested. “Testing all patients with breast cancer at diagnosis can increase testing access and uptake and identify many more pathogenic variant carriers for screening and prevention.”
To see if such a broad roll-out would be economically and medically feasible and beneficial, the investigators performed a modeling study involving 11,836 women with breast cancer, with data drawn from four large databases in the United Kingdom, the United States, and Australia.
The model compared annual costs, number of detected cases of breast cancer and ovarian cancer, and related rates of mortality between standard BRCA testing based on clinical criteria or family history versus high-risk multigene testing (BRCA1/BRCA2/PALB2) for all patients with breast cancer.
Resultant incremental cost-effectiveness ratios (ICERs) showed that in both the United Kingdom and the United States, multigene testing would cost, on average, significantly less than minimum willingness-to-pay thresholds of £30,000 per quality-adjusted life-year (QALY) and $100,000/QALY, respectively. In the United Kingdom, the estimated cost of multigene testing was £10,464/QALY from a payer’s perspective and £7,216/QALY from a societal perspective, the latter of which incorporates economic costs beyond the health care system. In the United States, these values rose to $65,661/QALY (payer perspective) and $61,618/QALY (societal perspective). Probabilistic sensitivity analysis suggested that multigene testing would be cost-effective for almost all health system simulations in the United Kingdom (98%-99%) and approximately two-thirds of those in the United States (64%-68%).
Epidemiologically, in the United Kingdom, multigene testing could potentially prevent 2,101 cases of breast cancer and ovarian cancer and 633 deaths per year, while in the United States, 9,733 cases might be prevented, with 2,406 lives saved.
“Our analysis suggests that an unselected testing strategy is extremely cost-effective for U.K. and U.S. health systems and provides a basis for change in current guidelines and policy to implement this strategy,” the investigators said.
The study was funded by the National Cancer Institute, the State of Washington, the Fred Hutchinson Cancer Research Center, and others. The investigators reported additional relationships with AstraZeneca, the Manchester National Institute for Health Research Biomedical Research Centre, Cancer Research UK, an others.
SOURCE: Sun et al. JAMA Oncol. 2019 Oct 3. doi: 10.1001/jamaoncol.2019.3323.
Although detection of more pathogenic variants among patients with breast cancer may initially appear beneficial, the hidden risks and costs associated with broader multigene testing would likely outweigh the benefits.
Present guidelines, such as those provided by the National Comprehensive Cancer Network, already include effective strategies for detecting BRCA1/2 variants, as only 0.6% of patients who do not meet screening guidelines are estimated to test positive
Beyond BRCA1/2, the clinical relevance of pathogenic variants becomes dubious, as many genetic aberrations are not actionable. Furthermore, misinterpretation of unfamiliar results may increase risks of treatment decisions that might actually harm patients. While some argue that broader testing could have benefits for family members, this is poorly supported with evidence.
Behind the allegedly falling costs of genetic sequencing, true costs are hidden with corporate policies that reduce patient financial liability. It is worth noting that two publicly held testing companies recently reported annual revenues of $144 million and $498 million, representing money drawn largely from third-party payers covering guideline-recommended testing. Instead of concrete science, the popularity of multigene testing is more likely driven by active marketing and technological convenience. More independent studies are needed.
Mark Robson, MD, is with the department of breast cancer medicine and clinical genetics at Memorial Sloan Kettering Cancer Center in New York. Susan Domchek, MD is with the Basser Center for BRCA at the University of Pennsylvania in Philadelphia. Dr. Robson disclosed financial relationships with AstraZeneca, McKesson, and Pfizer. Dr. Domchek reported personal fees from Clovis, AstraZeneca, and BMS. Their remarks are adapted from an editorial (JAMA Oncol. 2019 Oct 3. doi: 10.1001/jamaoncol.2019.4004).
Although detection of more pathogenic variants among patients with breast cancer may initially appear beneficial, the hidden risks and costs associated with broader multigene testing would likely outweigh the benefits.
Present guidelines, such as those provided by the National Comprehensive Cancer Network, already include effective strategies for detecting BRCA1/2 variants, as only 0.6% of patients who do not meet screening guidelines are estimated to test positive
Beyond BRCA1/2, the clinical relevance of pathogenic variants becomes dubious, as many genetic aberrations are not actionable. Furthermore, misinterpretation of unfamiliar results may increase risks of treatment decisions that might actually harm patients. While some argue that broader testing could have benefits for family members, this is poorly supported with evidence.
Behind the allegedly falling costs of genetic sequencing, true costs are hidden with corporate policies that reduce patient financial liability. It is worth noting that two publicly held testing companies recently reported annual revenues of $144 million and $498 million, representing money drawn largely from third-party payers covering guideline-recommended testing. Instead of concrete science, the popularity of multigene testing is more likely driven by active marketing and technological convenience. More independent studies are needed.
Mark Robson, MD, is with the department of breast cancer medicine and clinical genetics at Memorial Sloan Kettering Cancer Center in New York. Susan Domchek, MD is with the Basser Center for BRCA at the University of Pennsylvania in Philadelphia. Dr. Robson disclosed financial relationships with AstraZeneca, McKesson, and Pfizer. Dr. Domchek reported personal fees from Clovis, AstraZeneca, and BMS. Their remarks are adapted from an editorial (JAMA Oncol. 2019 Oct 3. doi: 10.1001/jamaoncol.2019.4004).
Although detection of more pathogenic variants among patients with breast cancer may initially appear beneficial, the hidden risks and costs associated with broader multigene testing would likely outweigh the benefits.
Present guidelines, such as those provided by the National Comprehensive Cancer Network, already include effective strategies for detecting BRCA1/2 variants, as only 0.6% of patients who do not meet screening guidelines are estimated to test positive
Beyond BRCA1/2, the clinical relevance of pathogenic variants becomes dubious, as many genetic aberrations are not actionable. Furthermore, misinterpretation of unfamiliar results may increase risks of treatment decisions that might actually harm patients. While some argue that broader testing could have benefits for family members, this is poorly supported with evidence.
Behind the allegedly falling costs of genetic sequencing, true costs are hidden with corporate policies that reduce patient financial liability. It is worth noting that two publicly held testing companies recently reported annual revenues of $144 million and $498 million, representing money drawn largely from third-party payers covering guideline-recommended testing. Instead of concrete science, the popularity of multigene testing is more likely driven by active marketing and technological convenience. More independent studies are needed.
Mark Robson, MD, is with the department of breast cancer medicine and clinical genetics at Memorial Sloan Kettering Cancer Center in New York. Susan Domchek, MD is with the Basser Center for BRCA at the University of Pennsylvania in Philadelphia. Dr. Robson disclosed financial relationships with AstraZeneca, McKesson, and Pfizer. Dr. Domchek reported personal fees from Clovis, AstraZeneca, and BMS. Their remarks are adapted from an editorial (JAMA Oncol. 2019 Oct 3. doi: 10.1001/jamaoncol.2019.4004).
High-risk multigene testing for all patients with breast cancer may be a cost-effective way to reduce rates of breast cancer and ovarian cancer, according to investigators.
A microsimulation modeling study suggested that moving from standard BRCA testing based on clinical criteria or family history to widespread adoption of multigene testing could potentially save more than 2,400 lives per year in the United States, reported lead author Li Sun, MSc, of the London School of Hygiene & Tropical Medicine, and colleagues.
“Moving toward unselected BC testing may give an impetus for prevention in unaffected family members along with clinical implications for the patient with BC. Pathogenic variant carriers with newly diagnosed BC can opt for bilateral mastectomy rather than breast conservation at initial BC surgery,” the investigators wrote in JAMA Oncology. They noted that, presently, only 20%-30% of eligible patients are actually tested. “Testing all patients with breast cancer at diagnosis can increase testing access and uptake and identify many more pathogenic variant carriers for screening and prevention.”
To see if such a broad roll-out would be economically and medically feasible and beneficial, the investigators performed a modeling study involving 11,836 women with breast cancer, with data drawn from four large databases in the United Kingdom, the United States, and Australia.
The model compared annual costs, number of detected cases of breast cancer and ovarian cancer, and related rates of mortality between standard BRCA testing based on clinical criteria or family history versus high-risk multigene testing (BRCA1/BRCA2/PALB2) for all patients with breast cancer.
Resultant incremental cost-effectiveness ratios (ICERs) showed that in both the United Kingdom and the United States, multigene testing would cost, on average, significantly less than minimum willingness-to-pay thresholds of £30,000 per quality-adjusted life-year (QALY) and $100,000/QALY, respectively. In the United Kingdom, the estimated cost of multigene testing was £10,464/QALY from a payer’s perspective and £7,216/QALY from a societal perspective, the latter of which incorporates economic costs beyond the health care system. In the United States, these values rose to $65,661/QALY (payer perspective) and $61,618/QALY (societal perspective). Probabilistic sensitivity analysis suggested that multigene testing would be cost-effective for almost all health system simulations in the United Kingdom (98%-99%) and approximately two-thirds of those in the United States (64%-68%).
Epidemiologically, in the United Kingdom, multigene testing could potentially prevent 2,101 cases of breast cancer and ovarian cancer and 633 deaths per year, while in the United States, 9,733 cases might be prevented, with 2,406 lives saved.
“Our analysis suggests that an unselected testing strategy is extremely cost-effective for U.K. and U.S. health systems and provides a basis for change in current guidelines and policy to implement this strategy,” the investigators said.
The study was funded by the National Cancer Institute, the State of Washington, the Fred Hutchinson Cancer Research Center, and others. The investigators reported additional relationships with AstraZeneca, the Manchester National Institute for Health Research Biomedical Research Centre, Cancer Research UK, an others.
SOURCE: Sun et al. JAMA Oncol. 2019 Oct 3. doi: 10.1001/jamaoncol.2019.3323.
High-risk multigene testing for all patients with breast cancer may be a cost-effective way to reduce rates of breast cancer and ovarian cancer, according to investigators.
A microsimulation modeling study suggested that moving from standard BRCA testing based on clinical criteria or family history to widespread adoption of multigene testing could potentially save more than 2,400 lives per year in the United States, reported lead author Li Sun, MSc, of the London School of Hygiene & Tropical Medicine, and colleagues.
“Moving toward unselected BC testing may give an impetus for prevention in unaffected family members along with clinical implications for the patient with BC. Pathogenic variant carriers with newly diagnosed BC can opt for bilateral mastectomy rather than breast conservation at initial BC surgery,” the investigators wrote in JAMA Oncology. They noted that, presently, only 20%-30% of eligible patients are actually tested. “Testing all patients with breast cancer at diagnosis can increase testing access and uptake and identify many more pathogenic variant carriers for screening and prevention.”
To see if such a broad roll-out would be economically and medically feasible and beneficial, the investigators performed a modeling study involving 11,836 women with breast cancer, with data drawn from four large databases in the United Kingdom, the United States, and Australia.
The model compared annual costs, number of detected cases of breast cancer and ovarian cancer, and related rates of mortality between standard BRCA testing based on clinical criteria or family history versus high-risk multigene testing (BRCA1/BRCA2/PALB2) for all patients with breast cancer.
Resultant incremental cost-effectiveness ratios (ICERs) showed that in both the United Kingdom and the United States, multigene testing would cost, on average, significantly less than minimum willingness-to-pay thresholds of £30,000 per quality-adjusted life-year (QALY) and $100,000/QALY, respectively. In the United Kingdom, the estimated cost of multigene testing was £10,464/QALY from a payer’s perspective and £7,216/QALY from a societal perspective, the latter of which incorporates economic costs beyond the health care system. In the United States, these values rose to $65,661/QALY (payer perspective) and $61,618/QALY (societal perspective). Probabilistic sensitivity analysis suggested that multigene testing would be cost-effective for almost all health system simulations in the United Kingdom (98%-99%) and approximately two-thirds of those in the United States (64%-68%).
Epidemiologically, in the United Kingdom, multigene testing could potentially prevent 2,101 cases of breast cancer and ovarian cancer and 633 deaths per year, while in the United States, 9,733 cases might be prevented, with 2,406 lives saved.
“Our analysis suggests that an unselected testing strategy is extremely cost-effective for U.K. and U.S. health systems and provides a basis for change in current guidelines and policy to implement this strategy,” the investigators said.
The study was funded by the National Cancer Institute, the State of Washington, the Fred Hutchinson Cancer Research Center, and others. The investigators reported additional relationships with AstraZeneca, the Manchester National Institute for Health Research Biomedical Research Centre, Cancer Research UK, an others.
SOURCE: Sun et al. JAMA Oncol. 2019 Oct 3. doi: 10.1001/jamaoncol.2019.3323.
FROM JAMA ONCOLOGY
Tennessee’s Medicaid block grant proposal could have deep impacts
In late September, Gov. Bill Lee (R) submitted a draft proposal to the Trump administration requesting the government convert the federal share of the state’s Medicaid funding into a $7.9 billion lump sum.
Under the proposal, the federal spending cap would apply to currently eligible children and adults, patients covered based on disability, and currently eligible seniors, but not to newly eligible patients, prescription drugs, dually eligible enrollees, and reimbursement to disproportionate-share hospitals and critical access hospitals. The proposed block grant would increase on a per capita basis for new patients and would adjust annually for inflation.
Gov. Lee contends the block grant would allow for more efficiency in the state’s Medicaid program – called TennCare – and generate significant savings, which the state would split 50/50 with the federal government, according to the proposal.
“The traditional model of Medicaid financing is an outdated model of fundamentally misaligned incentives,” Gov. Lee said in the waiver request. “New models of Medicaid financing are needed that reward states for promoting value and health, not merely spending more money. Tennessee’s Medicaid block grant proposal represents a natural progression of the state’s history of nationally recognized innovation and financial management. It also ensures that TennCare members continue to receive high-quality, cost-effective care well into the future.”
Tennessee’s proposal aims to provide care to low-income recipients more efficiently, while breaking Medicaid’s “perverse dynamic” in which states seek to extract more money from the federal government, said Doug Badger, a visiting fellow in domestic policy studies at the conservative-leaning Heritage Foundation.
“The waiver would incentivize Tennessee to reduce federal spending while maintaining access to care,” Mr. Badger said in an interview. “It is an idea worth testing. Tennessee will have to convince federal officials that its proposal would maintain quality of care without increasing federal spending. If they clear those hurdles, the federal government should approve the waiver.”
However, Dan Hawkins, senior vice president for public policy and research at the nonpartisan National Association of Community Health Centers said the proposal contains some concerning omissions and extreme demands that could affect access to care. For instance, the waiver calls for complete exemption from federal Medicaid requirements, including managed care rules that ensure access and network adequacy protections, pregnancy care rules, requirements pertaining to the treatment of disabled adults and children, and early and periodic screening, diagnostic, and treatment (EPSDT) requirements. Under the waiver, the state would no longer be subject to federal oversight for its enrollment, coverage, or management decisions.
“The most shocking thing is that [Tennessee has] provided no estimate of impact on the population served, either in terms of their health or their ability to access care or the amount of money it would cost to serve them,” Mr. Hawkins said in an interview. “They are essentially saying, ‘Send [the block grant] to us and go away.’ ”
Without the federal protections, Tennessee could take any number of measures to reduce costs, adds Andy Schneider a research professor at Georgetown University and an analyst for Georgetown University Health Policy Institute’s Center for Children and Families, both in Washington. Mr. Schneider served as a senior advisor at the Centers for Medicare & Medicaid Services under the Obama administration.
“What would the state do in a world where it no longer had to follow federal rules in contracting with risk-based managed care organizations [MCOs] and in a world where it wanted to save money?” Mr. Schneider said in an interview. “Well, without the federal protections, it could reduce its payments on behalf of enrolled beneficiaries to the MCOs, it could not require the MCOs to have adequate provider networks, not require the MCOs to describe what services they were or were not providing, it could eliminate appeals protections for beneficiaries. Just let your imagination run wild.”
It is uncertain whether the waiver will be approved. Mr. Hawkins noted that CMS leadership has expressed support for the notion of a block grant. In his 2020 fiscal year federal budget for example, President Trump proposed a number of changes to Medicaid, including the potential for state Medicaid block grants or per capita caps. The Office of Management and Budget, meanwhile, is currently preparing guidance for state governments on creating block grants for Medicaid.
“On the other hand, this proposal is so outrageous I have to believe that even the federal government, even CMS, would blanch and come back requiring some additional changes in return for approving the proposal,” Mr. Hawkins said.
Mr. Schneider believes if the block grant is approved, it will likely face immediate litigation.
“The Department of Health & Human Services does not have the authority to give the state a block grant, only Congress can do that,” said Mr. Schneider who recently blogged about the proposal. “The reason for that is that, as the state makes clear in its proposal, it wants to reimagine the traditional Medicaid financing arrangement. That traditional financing arrangement has been in place since 1965. The executive branch can’t [change] it. It simply does not have the authority.”
Mr. Badger emphasized there is no shortage of speculation about the impact of fixed Medicaid allotments. What is needed now, he said, is evidence.
“A well-designed demonstration project will yield that evidence,” he said. “The statute gives the [HHS] Secretary authority to authorize demonstrations precisely to replace speculation with data. The best way to assess the impact of a fixed allotment is to test it in the real world.”
Tennessee will hold public hearings about its proposal in early October and collect feedback through Oct. 18. A final proposal is expected in November.
In late September, Gov. Bill Lee (R) submitted a draft proposal to the Trump administration requesting the government convert the federal share of the state’s Medicaid funding into a $7.9 billion lump sum.
Under the proposal, the federal spending cap would apply to currently eligible children and adults, patients covered based on disability, and currently eligible seniors, but not to newly eligible patients, prescription drugs, dually eligible enrollees, and reimbursement to disproportionate-share hospitals and critical access hospitals. The proposed block grant would increase on a per capita basis for new patients and would adjust annually for inflation.
Gov. Lee contends the block grant would allow for more efficiency in the state’s Medicaid program – called TennCare – and generate significant savings, which the state would split 50/50 with the federal government, according to the proposal.
“The traditional model of Medicaid financing is an outdated model of fundamentally misaligned incentives,” Gov. Lee said in the waiver request. “New models of Medicaid financing are needed that reward states for promoting value and health, not merely spending more money. Tennessee’s Medicaid block grant proposal represents a natural progression of the state’s history of nationally recognized innovation and financial management. It also ensures that TennCare members continue to receive high-quality, cost-effective care well into the future.”
Tennessee’s proposal aims to provide care to low-income recipients more efficiently, while breaking Medicaid’s “perverse dynamic” in which states seek to extract more money from the federal government, said Doug Badger, a visiting fellow in domestic policy studies at the conservative-leaning Heritage Foundation.
“The waiver would incentivize Tennessee to reduce federal spending while maintaining access to care,” Mr. Badger said in an interview. “It is an idea worth testing. Tennessee will have to convince federal officials that its proposal would maintain quality of care without increasing federal spending. If they clear those hurdles, the federal government should approve the waiver.”
However, Dan Hawkins, senior vice president for public policy and research at the nonpartisan National Association of Community Health Centers said the proposal contains some concerning omissions and extreme demands that could affect access to care. For instance, the waiver calls for complete exemption from federal Medicaid requirements, including managed care rules that ensure access and network adequacy protections, pregnancy care rules, requirements pertaining to the treatment of disabled adults and children, and early and periodic screening, diagnostic, and treatment (EPSDT) requirements. Under the waiver, the state would no longer be subject to federal oversight for its enrollment, coverage, or management decisions.
“The most shocking thing is that [Tennessee has] provided no estimate of impact on the population served, either in terms of their health or their ability to access care or the amount of money it would cost to serve them,” Mr. Hawkins said in an interview. “They are essentially saying, ‘Send [the block grant] to us and go away.’ ”
Without the federal protections, Tennessee could take any number of measures to reduce costs, adds Andy Schneider a research professor at Georgetown University and an analyst for Georgetown University Health Policy Institute’s Center for Children and Families, both in Washington. Mr. Schneider served as a senior advisor at the Centers for Medicare & Medicaid Services under the Obama administration.
“What would the state do in a world where it no longer had to follow federal rules in contracting with risk-based managed care organizations [MCOs] and in a world where it wanted to save money?” Mr. Schneider said in an interview. “Well, without the federal protections, it could reduce its payments on behalf of enrolled beneficiaries to the MCOs, it could not require the MCOs to have adequate provider networks, not require the MCOs to describe what services they were or were not providing, it could eliminate appeals protections for beneficiaries. Just let your imagination run wild.”
It is uncertain whether the waiver will be approved. Mr. Hawkins noted that CMS leadership has expressed support for the notion of a block grant. In his 2020 fiscal year federal budget for example, President Trump proposed a number of changes to Medicaid, including the potential for state Medicaid block grants or per capita caps. The Office of Management and Budget, meanwhile, is currently preparing guidance for state governments on creating block grants for Medicaid.
“On the other hand, this proposal is so outrageous I have to believe that even the federal government, even CMS, would blanch and come back requiring some additional changes in return for approving the proposal,” Mr. Hawkins said.
Mr. Schneider believes if the block grant is approved, it will likely face immediate litigation.
“The Department of Health & Human Services does not have the authority to give the state a block grant, only Congress can do that,” said Mr. Schneider who recently blogged about the proposal. “The reason for that is that, as the state makes clear in its proposal, it wants to reimagine the traditional Medicaid financing arrangement. That traditional financing arrangement has been in place since 1965. The executive branch can’t [change] it. It simply does not have the authority.”
Mr. Badger emphasized there is no shortage of speculation about the impact of fixed Medicaid allotments. What is needed now, he said, is evidence.
“A well-designed demonstration project will yield that evidence,” he said. “The statute gives the [HHS] Secretary authority to authorize demonstrations precisely to replace speculation with data. The best way to assess the impact of a fixed allotment is to test it in the real world.”
Tennessee will hold public hearings about its proposal in early October and collect feedback through Oct. 18. A final proposal is expected in November.
In late September, Gov. Bill Lee (R) submitted a draft proposal to the Trump administration requesting the government convert the federal share of the state’s Medicaid funding into a $7.9 billion lump sum.
Under the proposal, the federal spending cap would apply to currently eligible children and adults, patients covered based on disability, and currently eligible seniors, but not to newly eligible patients, prescription drugs, dually eligible enrollees, and reimbursement to disproportionate-share hospitals and critical access hospitals. The proposed block grant would increase on a per capita basis for new patients and would adjust annually for inflation.
Gov. Lee contends the block grant would allow for more efficiency in the state’s Medicaid program – called TennCare – and generate significant savings, which the state would split 50/50 with the federal government, according to the proposal.
“The traditional model of Medicaid financing is an outdated model of fundamentally misaligned incentives,” Gov. Lee said in the waiver request. “New models of Medicaid financing are needed that reward states for promoting value and health, not merely spending more money. Tennessee’s Medicaid block grant proposal represents a natural progression of the state’s history of nationally recognized innovation and financial management. It also ensures that TennCare members continue to receive high-quality, cost-effective care well into the future.”
Tennessee’s proposal aims to provide care to low-income recipients more efficiently, while breaking Medicaid’s “perverse dynamic” in which states seek to extract more money from the federal government, said Doug Badger, a visiting fellow in domestic policy studies at the conservative-leaning Heritage Foundation.
“The waiver would incentivize Tennessee to reduce federal spending while maintaining access to care,” Mr. Badger said in an interview. “It is an idea worth testing. Tennessee will have to convince federal officials that its proposal would maintain quality of care without increasing federal spending. If they clear those hurdles, the federal government should approve the waiver.”
However, Dan Hawkins, senior vice president for public policy and research at the nonpartisan National Association of Community Health Centers said the proposal contains some concerning omissions and extreme demands that could affect access to care. For instance, the waiver calls for complete exemption from federal Medicaid requirements, including managed care rules that ensure access and network adequacy protections, pregnancy care rules, requirements pertaining to the treatment of disabled adults and children, and early and periodic screening, diagnostic, and treatment (EPSDT) requirements. Under the waiver, the state would no longer be subject to federal oversight for its enrollment, coverage, or management decisions.
“The most shocking thing is that [Tennessee has] provided no estimate of impact on the population served, either in terms of their health or their ability to access care or the amount of money it would cost to serve them,” Mr. Hawkins said in an interview. “They are essentially saying, ‘Send [the block grant] to us and go away.’ ”
Without the federal protections, Tennessee could take any number of measures to reduce costs, adds Andy Schneider a research professor at Georgetown University and an analyst for Georgetown University Health Policy Institute’s Center for Children and Families, both in Washington. Mr. Schneider served as a senior advisor at the Centers for Medicare & Medicaid Services under the Obama administration.
“What would the state do in a world where it no longer had to follow federal rules in contracting with risk-based managed care organizations [MCOs] and in a world where it wanted to save money?” Mr. Schneider said in an interview. “Well, without the federal protections, it could reduce its payments on behalf of enrolled beneficiaries to the MCOs, it could not require the MCOs to have adequate provider networks, not require the MCOs to describe what services they were or were not providing, it could eliminate appeals protections for beneficiaries. Just let your imagination run wild.”
It is uncertain whether the waiver will be approved. Mr. Hawkins noted that CMS leadership has expressed support for the notion of a block grant. In his 2020 fiscal year federal budget for example, President Trump proposed a number of changes to Medicaid, including the potential for state Medicaid block grants or per capita caps. The Office of Management and Budget, meanwhile, is currently preparing guidance for state governments on creating block grants for Medicaid.
“On the other hand, this proposal is so outrageous I have to believe that even the federal government, even CMS, would blanch and come back requiring some additional changes in return for approving the proposal,” Mr. Hawkins said.
Mr. Schneider believes if the block grant is approved, it will likely face immediate litigation.
“The Department of Health & Human Services does not have the authority to give the state a block grant, only Congress can do that,” said Mr. Schneider who recently blogged about the proposal. “The reason for that is that, as the state makes clear in its proposal, it wants to reimagine the traditional Medicaid financing arrangement. That traditional financing arrangement has been in place since 1965. The executive branch can’t [change] it. It simply does not have the authority.”
Mr. Badger emphasized there is no shortage of speculation about the impact of fixed Medicaid allotments. What is needed now, he said, is evidence.
“A well-designed demonstration project will yield that evidence,” he said. “The statute gives the [HHS] Secretary authority to authorize demonstrations precisely to replace speculation with data. The best way to assess the impact of a fixed allotment is to test it in the real world.”
Tennessee will hold public hearings about its proposal in early October and collect feedback through Oct. 18. A final proposal is expected in November.
AAFP Congress adopts resolutions on physician privileges, medical education, employee benefits
PHILADELPHIA –
Practice enhancement
Hospital privileges were a hot topic for the reference committee on practice enhancement.
Adopted Resolution No. 304 calls on AAFP to oppose health insurance companies “privileging physicians based solely on their hospital privileges and hospital credentials.” The new rule also resolves that AAFP engage major national health insurance companies to develop methods to credential physicians that do not depend on hospital privileges.
The Congress also adopted Substitute Resolution No. 305, which calls on the AAFP to collaborate with the Joint Commission and other appropriate entities to create policy stating that hospitals remove undue barriers and restriction of privileges to hospitals and intensive care units for qualified family physicians who practice hospital medicine.
Delegates requested amendments to a resolution that called on AAFP to oppose nonphysician health care professionals making credentialing or privileging decisions regarding family physicians and that the AAFP oppose the use of nonphysician health care professionals in providing consultations requested of other physicians. The Congress could not agree on a final wording of the resolution.
Douglas J. Gruenbacher, MD, a Kansas delegate who works in a small hospital, said, “We actually credential in our hospital radiologists, orthopedists ... urologists. Do I know what they know? So we have to have many of our nonphysician providers, our nurse practitioners, help us. ... Should they be independent? No, of course not, but they do play an important part of our team.”
Douglas W. Curran, MD, a delegate from Texas, said, “I think we continue to give away stuff without taking care of ourselves. I have seen it for 4 years and, as result, we have seen this expansion of second-class care for people. ... Those are huge decisions, especially thinking about who’s going to do what in our hospitals. That includes small hospitals; I practice in a small hospital. I get all of that.”
After much debate, the Congress voted in favor of referring two proposed amendments to the board.
The Congress also adopted an amended version of Substitute Resolution No. 303, which calls on AAFP to support insurance coverage of acupuncture for pain control when ordered by a licensed physician or licensed collaborating advanced clinician on their practice team.
Education
Multipronged Substitute Resolution No. 606 – adopted by the Congress – aims to address racial inequities in medical education. Specifically, it calls on AAFP to do the following:
- Instruct the Liaison Committee for Medical Education to add race to its existing Cultural Competence and Health Care Disparities section 7.6 of Functions and Structure of a Medical School: Standards for Accreditation of Medical Education Programs Leading to the MD Degree.
- Ask the Accreditation Council for Graduate Medical Education to adopt an antiracism policy that includes corresponding curricular requirements,
- Develop and implement a policy on training in racism and implicit bias for officeholders and commission members.
- Take an active stance against racism when racist events occur within the medical community.
The Congress also adopted Resolution No. 611, which calls for the AAFP to encourage the expansion of clinical behavioral health fellowships for family medicine physicians.
The resolution received mixed testimony during the reference committee meeting, with those in favor of the resolution having cited the need for more education in behavioral health due to shortages in many communities. Opponents argued that completing the fellowship would not have added value in hospital privileging and insurance payment, because it would not lead physicians to earn a certificate of added qualification.
Delegates also passed Resolution 608, over the objections of the reference committee.
As adopted, the resolution calls for AAFP to express its concern that the American Board of Family Medicine (ABFM) Family Medicine Certification Longitudinal Assessment is the only alternative to 1-day-only certification exam, and for the AAFP to urge the ABFM to offer a longitudinal self-assessment process similar to the American Board of Obstetricians and Gynecologists self-assessment process to satisfy the cognitive component of ABFM’s continued certification requirement.
The Reference Committee on Education also referred several hotly debated resolutions back to the AAFP board of directors. No. 604 called on AAFP to support forgiving 1 year of federal medical student loans for every 2 years of full-time work in a primary care position, as well as tax credits for those working in rural or underserved areas.
Advocacy
The delegates also approved most of the recommendations of the reference committee on advocacy with little discussion.
Substitute Resolution No. 515, which was ultimately adopted with an amendment by the Congress, states that AAFP support policies that provide employees with reasonable benefits, including job security, wage replacement, and continued availability of health plan coverage in the event that leave by an employee becomes necessary for documented medical conditions, with protections for small businesses. Among the policies this resolution includes are the following:
- Medical leave for the employee, including pregnancy.
- Parental leave for the employee-parent, including leave for birth, adoption or foster care leading to adoption.
- Leave if medically appropriate to care for a member of the employee’s immediate family.
The Congress adopted several other resolutions recommended by the advocacy committee:
- Resolution No. 501, calling on AAFP to advocate for state-level adoption of the Interstate Medical Licensure Compact.
- Substitute Resolution No. 505, asking AAFP to request a National Coverage Determination for Cardiac Rehabilitation Programs to allow such programs to operate without physician supervision when an AED is immediately available, and the patient is attended by nursing staff currently trained in basic life support.
- Substitute Resolutions No. 506 and 507 to support and encourage the ability of parents to breastfeed in the workplace through its advocacy efforts, as well as promote the enforcements of current law.
- Resolution No. 508, to petition CMS, national health insurance companies, and pharmacy benefits managers to include all generic medications in a class within a health plan’s formulary and implement a system that informs the prescriber of all formulary alternatives to a medication when denying the same medication immediately upon denial, while also providing a mechanism to rapidly appeal the denial.
- Substitute Resolution No. 512, to petition the CMS to reevaluate its current policy on the time requirements for discharge summaries from hospitals and post-acute care facilities and specifically require such facilities to provide primary care physicians with discharge summaries within 7 days.
- Substitute Resolution No. 517, to unequivocally support the right of physicians to organize and bargain collectively.
- Substitute Resolution No. 519, to support legislation that decriminalizes people who are solicited for sex or sexual activities in exchange for money or goods, without supporting the legalization of the selling of sex, and advocate against legislation that decriminalizes sex-buying and third-parties who promote and/or profit from sex buying.
Some of the resolutions that incited many passionate responses during the reference committee on advocacy were not discussed during the Congress of Delegates meeting.
One of these asked the AAFP to oppose legislation of physician-patient decision making in child and adolescent gender-affirming care. Some in support of this resolution referred to this type of care as evidence-based medicine and said that legislators should be kept out of the exam room. Those opposed disagreed with classifying this type of care that way, noting that the long-term effects of some of the treatments are unknown.
During the reference committee, one opponent of the resolution, Lisa Gilbert, MD, claimed that gender-affirming care refers to blocking puberty, followed by cross-sex hormones,which would permanently sterilize the children. Dr. Gilbert, who identified herself as a member from Kansas speaking independently, added that if children have gone through puberty naturally, this would be a different discussion.
Kevin Wang, MD, an alternate delegate from Washington, who supported the resolution, noted that the rate of suicide in the transgender population is nine times that of the general population.
“I do want to emphasize that doing nothing does cause significant harm,” Dr. Wang said, The committee referred resolution No. 509 to the board for further clarification and study.
The merits of two other resolutions (No. 510 and No. 511), which called for the AAFP to no longer reject the use of “physician-assisted suicide” and “assisted suicide” and avoid the use of vague and euphemistic terms when referring to lethal medications prescribed with the intention of ending a patient’s life in statements and documents, also were heavily debated during the advocacy reference committee meeting. The committee recommended such resolutions be referred to the board for discussion.
The delegates approved the advocacy committee’s recommendations for Resolutions 509, 510, and 511.
PHILADELPHIA –
Practice enhancement
Hospital privileges were a hot topic for the reference committee on practice enhancement.
Adopted Resolution No. 304 calls on AAFP to oppose health insurance companies “privileging physicians based solely on their hospital privileges and hospital credentials.” The new rule also resolves that AAFP engage major national health insurance companies to develop methods to credential physicians that do not depend on hospital privileges.
The Congress also adopted Substitute Resolution No. 305, which calls on the AAFP to collaborate with the Joint Commission and other appropriate entities to create policy stating that hospitals remove undue barriers and restriction of privileges to hospitals and intensive care units for qualified family physicians who practice hospital medicine.
Delegates requested amendments to a resolution that called on AAFP to oppose nonphysician health care professionals making credentialing or privileging decisions regarding family physicians and that the AAFP oppose the use of nonphysician health care professionals in providing consultations requested of other physicians. The Congress could not agree on a final wording of the resolution.
Douglas J. Gruenbacher, MD, a Kansas delegate who works in a small hospital, said, “We actually credential in our hospital radiologists, orthopedists ... urologists. Do I know what they know? So we have to have many of our nonphysician providers, our nurse practitioners, help us. ... Should they be independent? No, of course not, but they do play an important part of our team.”
Douglas W. Curran, MD, a delegate from Texas, said, “I think we continue to give away stuff without taking care of ourselves. I have seen it for 4 years and, as result, we have seen this expansion of second-class care for people. ... Those are huge decisions, especially thinking about who’s going to do what in our hospitals. That includes small hospitals; I practice in a small hospital. I get all of that.”
After much debate, the Congress voted in favor of referring two proposed amendments to the board.
The Congress also adopted an amended version of Substitute Resolution No. 303, which calls on AAFP to support insurance coverage of acupuncture for pain control when ordered by a licensed physician or licensed collaborating advanced clinician on their practice team.
Education
Multipronged Substitute Resolution No. 606 – adopted by the Congress – aims to address racial inequities in medical education. Specifically, it calls on AAFP to do the following:
- Instruct the Liaison Committee for Medical Education to add race to its existing Cultural Competence and Health Care Disparities section 7.6 of Functions and Structure of a Medical School: Standards for Accreditation of Medical Education Programs Leading to the MD Degree.
- Ask the Accreditation Council for Graduate Medical Education to adopt an antiracism policy that includes corresponding curricular requirements,
- Develop and implement a policy on training in racism and implicit bias for officeholders and commission members.
- Take an active stance against racism when racist events occur within the medical community.
The Congress also adopted Resolution No. 611, which calls for the AAFP to encourage the expansion of clinical behavioral health fellowships for family medicine physicians.
The resolution received mixed testimony during the reference committee meeting, with those in favor of the resolution having cited the need for more education in behavioral health due to shortages in many communities. Opponents argued that completing the fellowship would not have added value in hospital privileging and insurance payment, because it would not lead physicians to earn a certificate of added qualification.
Delegates also passed Resolution 608, over the objections of the reference committee.
As adopted, the resolution calls for AAFP to express its concern that the American Board of Family Medicine (ABFM) Family Medicine Certification Longitudinal Assessment is the only alternative to 1-day-only certification exam, and for the AAFP to urge the ABFM to offer a longitudinal self-assessment process similar to the American Board of Obstetricians and Gynecologists self-assessment process to satisfy the cognitive component of ABFM’s continued certification requirement.
The Reference Committee on Education also referred several hotly debated resolutions back to the AAFP board of directors. No. 604 called on AAFP to support forgiving 1 year of federal medical student loans for every 2 years of full-time work in a primary care position, as well as tax credits for those working in rural or underserved areas.
Advocacy
The delegates also approved most of the recommendations of the reference committee on advocacy with little discussion.
Substitute Resolution No. 515, which was ultimately adopted with an amendment by the Congress, states that AAFP support policies that provide employees with reasonable benefits, including job security, wage replacement, and continued availability of health plan coverage in the event that leave by an employee becomes necessary for documented medical conditions, with protections for small businesses. Among the policies this resolution includes are the following:
- Medical leave for the employee, including pregnancy.
- Parental leave for the employee-parent, including leave for birth, adoption or foster care leading to adoption.
- Leave if medically appropriate to care for a member of the employee’s immediate family.
The Congress adopted several other resolutions recommended by the advocacy committee:
- Resolution No. 501, calling on AAFP to advocate for state-level adoption of the Interstate Medical Licensure Compact.
- Substitute Resolution No. 505, asking AAFP to request a National Coverage Determination for Cardiac Rehabilitation Programs to allow such programs to operate without physician supervision when an AED is immediately available, and the patient is attended by nursing staff currently trained in basic life support.
- Substitute Resolutions No. 506 and 507 to support and encourage the ability of parents to breastfeed in the workplace through its advocacy efforts, as well as promote the enforcements of current law.
- Resolution No. 508, to petition CMS, national health insurance companies, and pharmacy benefits managers to include all generic medications in a class within a health plan’s formulary and implement a system that informs the prescriber of all formulary alternatives to a medication when denying the same medication immediately upon denial, while also providing a mechanism to rapidly appeal the denial.
- Substitute Resolution No. 512, to petition the CMS to reevaluate its current policy on the time requirements for discharge summaries from hospitals and post-acute care facilities and specifically require such facilities to provide primary care physicians with discharge summaries within 7 days.
- Substitute Resolution No. 517, to unequivocally support the right of physicians to organize and bargain collectively.
- Substitute Resolution No. 519, to support legislation that decriminalizes people who are solicited for sex or sexual activities in exchange for money or goods, without supporting the legalization of the selling of sex, and advocate against legislation that decriminalizes sex-buying and third-parties who promote and/or profit from sex buying.
Some of the resolutions that incited many passionate responses during the reference committee on advocacy were not discussed during the Congress of Delegates meeting.
One of these asked the AAFP to oppose legislation of physician-patient decision making in child and adolescent gender-affirming care. Some in support of this resolution referred to this type of care as evidence-based medicine and said that legislators should be kept out of the exam room. Those opposed disagreed with classifying this type of care that way, noting that the long-term effects of some of the treatments are unknown.
During the reference committee, one opponent of the resolution, Lisa Gilbert, MD, claimed that gender-affirming care refers to blocking puberty, followed by cross-sex hormones,which would permanently sterilize the children. Dr. Gilbert, who identified herself as a member from Kansas speaking independently, added that if children have gone through puberty naturally, this would be a different discussion.
Kevin Wang, MD, an alternate delegate from Washington, who supported the resolution, noted that the rate of suicide in the transgender population is nine times that of the general population.
“I do want to emphasize that doing nothing does cause significant harm,” Dr. Wang said, The committee referred resolution No. 509 to the board for further clarification and study.
The merits of two other resolutions (No. 510 and No. 511), which called for the AAFP to no longer reject the use of “physician-assisted suicide” and “assisted suicide” and avoid the use of vague and euphemistic terms when referring to lethal medications prescribed with the intention of ending a patient’s life in statements and documents, also were heavily debated during the advocacy reference committee meeting. The committee recommended such resolutions be referred to the board for discussion.
The delegates approved the advocacy committee’s recommendations for Resolutions 509, 510, and 511.
PHILADELPHIA –
Practice enhancement
Hospital privileges were a hot topic for the reference committee on practice enhancement.
Adopted Resolution No. 304 calls on AAFP to oppose health insurance companies “privileging physicians based solely on their hospital privileges and hospital credentials.” The new rule also resolves that AAFP engage major national health insurance companies to develop methods to credential physicians that do not depend on hospital privileges.
The Congress also adopted Substitute Resolution No. 305, which calls on the AAFP to collaborate with the Joint Commission and other appropriate entities to create policy stating that hospitals remove undue barriers and restriction of privileges to hospitals and intensive care units for qualified family physicians who practice hospital medicine.
Delegates requested amendments to a resolution that called on AAFP to oppose nonphysician health care professionals making credentialing or privileging decisions regarding family physicians and that the AAFP oppose the use of nonphysician health care professionals in providing consultations requested of other physicians. The Congress could not agree on a final wording of the resolution.
Douglas J. Gruenbacher, MD, a Kansas delegate who works in a small hospital, said, “We actually credential in our hospital radiologists, orthopedists ... urologists. Do I know what they know? So we have to have many of our nonphysician providers, our nurse practitioners, help us. ... Should they be independent? No, of course not, but they do play an important part of our team.”
Douglas W. Curran, MD, a delegate from Texas, said, “I think we continue to give away stuff without taking care of ourselves. I have seen it for 4 years and, as result, we have seen this expansion of second-class care for people. ... Those are huge decisions, especially thinking about who’s going to do what in our hospitals. That includes small hospitals; I practice in a small hospital. I get all of that.”
After much debate, the Congress voted in favor of referring two proposed amendments to the board.
The Congress also adopted an amended version of Substitute Resolution No. 303, which calls on AAFP to support insurance coverage of acupuncture for pain control when ordered by a licensed physician or licensed collaborating advanced clinician on their practice team.
Education
Multipronged Substitute Resolution No. 606 – adopted by the Congress – aims to address racial inequities in medical education. Specifically, it calls on AAFP to do the following:
- Instruct the Liaison Committee for Medical Education to add race to its existing Cultural Competence and Health Care Disparities section 7.6 of Functions and Structure of a Medical School: Standards for Accreditation of Medical Education Programs Leading to the MD Degree.
- Ask the Accreditation Council for Graduate Medical Education to adopt an antiracism policy that includes corresponding curricular requirements,
- Develop and implement a policy on training in racism and implicit bias for officeholders and commission members.
- Take an active stance against racism when racist events occur within the medical community.
The Congress also adopted Resolution No. 611, which calls for the AAFP to encourage the expansion of clinical behavioral health fellowships for family medicine physicians.
The resolution received mixed testimony during the reference committee meeting, with those in favor of the resolution having cited the need for more education in behavioral health due to shortages in many communities. Opponents argued that completing the fellowship would not have added value in hospital privileging and insurance payment, because it would not lead physicians to earn a certificate of added qualification.
Delegates also passed Resolution 608, over the objections of the reference committee.
As adopted, the resolution calls for AAFP to express its concern that the American Board of Family Medicine (ABFM) Family Medicine Certification Longitudinal Assessment is the only alternative to 1-day-only certification exam, and for the AAFP to urge the ABFM to offer a longitudinal self-assessment process similar to the American Board of Obstetricians and Gynecologists self-assessment process to satisfy the cognitive component of ABFM’s continued certification requirement.
The Reference Committee on Education also referred several hotly debated resolutions back to the AAFP board of directors. No. 604 called on AAFP to support forgiving 1 year of federal medical student loans for every 2 years of full-time work in a primary care position, as well as tax credits for those working in rural or underserved areas.
Advocacy
The delegates also approved most of the recommendations of the reference committee on advocacy with little discussion.
Substitute Resolution No. 515, which was ultimately adopted with an amendment by the Congress, states that AAFP support policies that provide employees with reasonable benefits, including job security, wage replacement, and continued availability of health plan coverage in the event that leave by an employee becomes necessary for documented medical conditions, with protections for small businesses. Among the policies this resolution includes are the following:
- Medical leave for the employee, including pregnancy.
- Parental leave for the employee-parent, including leave for birth, adoption or foster care leading to adoption.
- Leave if medically appropriate to care for a member of the employee’s immediate family.
The Congress adopted several other resolutions recommended by the advocacy committee:
- Resolution No. 501, calling on AAFP to advocate for state-level adoption of the Interstate Medical Licensure Compact.
- Substitute Resolution No. 505, asking AAFP to request a National Coverage Determination for Cardiac Rehabilitation Programs to allow such programs to operate without physician supervision when an AED is immediately available, and the patient is attended by nursing staff currently trained in basic life support.
- Substitute Resolutions No. 506 and 507 to support and encourage the ability of parents to breastfeed in the workplace through its advocacy efforts, as well as promote the enforcements of current law.
- Resolution No. 508, to petition CMS, national health insurance companies, and pharmacy benefits managers to include all generic medications in a class within a health plan’s formulary and implement a system that informs the prescriber of all formulary alternatives to a medication when denying the same medication immediately upon denial, while also providing a mechanism to rapidly appeal the denial.
- Substitute Resolution No. 512, to petition the CMS to reevaluate its current policy on the time requirements for discharge summaries from hospitals and post-acute care facilities and specifically require such facilities to provide primary care physicians with discharge summaries within 7 days.
- Substitute Resolution No. 517, to unequivocally support the right of physicians to organize and bargain collectively.
- Substitute Resolution No. 519, to support legislation that decriminalizes people who are solicited for sex or sexual activities in exchange for money or goods, without supporting the legalization of the selling of sex, and advocate against legislation that decriminalizes sex-buying and third-parties who promote and/or profit from sex buying.
Some of the resolutions that incited many passionate responses during the reference committee on advocacy were not discussed during the Congress of Delegates meeting.
One of these asked the AAFP to oppose legislation of physician-patient decision making in child and adolescent gender-affirming care. Some in support of this resolution referred to this type of care as evidence-based medicine and said that legislators should be kept out of the exam room. Those opposed disagreed with classifying this type of care that way, noting that the long-term effects of some of the treatments are unknown.
During the reference committee, one opponent of the resolution, Lisa Gilbert, MD, claimed that gender-affirming care refers to blocking puberty, followed by cross-sex hormones,which would permanently sterilize the children. Dr. Gilbert, who identified herself as a member from Kansas speaking independently, added that if children have gone through puberty naturally, this would be a different discussion.
Kevin Wang, MD, an alternate delegate from Washington, who supported the resolution, noted that the rate of suicide in the transgender population is nine times that of the general population.
“I do want to emphasize that doing nothing does cause significant harm,” Dr. Wang said, The committee referred resolution No. 509 to the board for further clarification and study.
The merits of two other resolutions (No. 510 and No. 511), which called for the AAFP to no longer reject the use of “physician-assisted suicide” and “assisted suicide” and avoid the use of vague and euphemistic terms when referring to lethal medications prescribed with the intention of ending a patient’s life in statements and documents, also were heavily debated during the advocacy reference committee meeting. The committee recommended such resolutions be referred to the board for discussion.
The delegates approved the advocacy committee’s recommendations for Resolutions 509, 510, and 511.
REPORTING FROM AAFP Congress