Ob.Gyn. News

Taking more steps each day, in short spurts or longer bouts, was associated with a longer life in women older than 60 years, according to data from more than 16,000 participants in the ongoing Women’s Health Study.

The American Heart Association recommends at least 150 minutes per week of moderate physical activity, 75 minutes of vigorous physical activity, or a combination of both as fitness guidelines for adults. Walking is a safe and easy way for many adults to follow these guidelines, according to Christopher C. Moore, MS, a PhD candidate at the University of North Carolina at Chapel Hill.

The popularity of step counts reflect that they are simple and objective, and “focusing on steps can help promote an active lifestyle,” he said. Data on the impact of sporadic steps accumulated outside of longer bouts of activity on health outcomes are limited; however, technology advances in the form of fitness apps and wearable devices make it possible for researchers to track and measure the benefits of short periods of activity as well as longer periods.

In a study presented at the Epidemiology and Prevention/Lifestyle and Cardiometabolic Health meeting, sponsored by the AHA, Mr. Moore and colleagues assessed data from women older than 60 years who used wearable step-counting devices to measure their daily steps and walking patterns.

The study population included 16,732 women enrolled in the Women’s Health Study, a longstanding study of heart disease, cancer, and disease prevention among women in the United States. The participants wore waist step counters 4-7 days a week during 2011-2015. The average of the women was 72 years; 96% were non-Hispanic White, and the average BMI was 26 kg/m².

The researchers divided the total number of steps for each study participant into two groups: “bouted” steps, defined as 10 minutes or longer bouts of walking with few interruptions; and “sporadic” steps, defined as short spurts of walking during regular daily activities such as housework, taking the stairs, or walking to or from a car.

A total of 804 deaths occurred during an average of 6 years of follow-up. Each initial increase of 1,000 steps including sporadic or bouted steps was associated with a 28% decrease in death, compared with no daily steps (hazard ratio, 0.72).

Each increasing quartile of sporadic steps was linked with higher total steps per day, Mr. Moore said. “Initial increase in sporadic steps corresponded to the greatest reductions in mortality,” with a HR of 0.69 per additional sporadic steps below 3,200 per day, and the impact on reduced mortality plateaued at about 4,500 sporadic steps per day.

In further analysis, the researchers also found a roughly 32% decrease in death in participants who took more than 2,000 steps daily in uninterrupted bouts (HR, 0.69).

The study findings were limited by several factors, including the relatively short follow-up period and number of events, the assessment of steps at a single time point, and the mostly homogeneous population, Mr. Moore noted. Additional research is needed to assess whether the results are generalizable to men, younger women, and diverse racial and ethnic groups.

However, the results may have implications for public health messaging, he emphasized. The message is that, to impact longevity, the total volume of steps is more important than the type of activity through which they are accumulated.

“You can accumulate your steps through longer bouts of purposeful activity or through everyday behaviors such as walking to your car, taking the stairs, and doing housework,” Mr. Moore concluded.

Find a friend, both of you benefit

On the basis of this study and other available evidence, more steps daily are recommended for everyone, Nieca Goldberg, MD, a cardiologist at New York University Langone Health, said in an interview.

“You can increase minutes of walking and frequency of walking,” she said.

Dr. Goldberg emphasized that you don’t need a fancy app or wearable device to up your steps. She offered some tips to help overcome barriers to putting one foot in front of the other. “Take the steps instead of the elevator. Park your car farther from your destination so you can walk.” Also, you can help yourself and help a friend to better health. “Get a walking buddy so you can encourage each other to walk,” Dr. Goldberg added.

Mr. Moore and Dr. Goldberg had no financial conflicts to disclose. The Women’s Health Study is funded by Brigham and Women’s Hospital; the National Heart, Lung, and Blood Institute; and the National Cancer Institute. Mr. Moore was funded by a grant from the NHLBI but had no other financial conflicts to disclose.

Taking more steps each day, in short spurts or longer bouts, was associated with a longer life in women older than 60 years, according to data from more than 16,000 participants in the ongoing Women’s Health Study.

The American Heart Association recommends at least 150 minutes per week of moderate physical activity, 75 minutes of vigorous physical activity, or a combination of both as fitness guidelines for adults. Walking is a safe and easy way for many adults to follow these guidelines, according to Christopher C. Moore, MS, a PhD candidate at the University of North Carolina at Chapel Hill.

The popularity of step counts reflect that they are simple and objective, and “focusing on steps can help promote an active lifestyle,” he said. Data on the impact of sporadic steps accumulated outside of longer bouts of activity on health outcomes are limited; however, technology advances in the form of fitness apps and wearable devices make it possible for researchers to track and measure the benefits of short periods of activity as well as longer periods.

In a study presented at the Epidemiology and Prevention/Lifestyle and Cardiometabolic Health meeting, sponsored by the AHA, Mr. Moore and colleagues assessed data from women older than 60 years who used wearable step-counting devices to measure their daily steps and walking patterns.

The study population included 16,732 women enrolled in the Women’s Health Study, a longstanding study of heart disease, cancer, and disease prevention among women in the United States. The participants wore waist step counters 4-7 days a week during 2011-2015. The average of the women was 72 years; 96% were non-Hispanic White, and the average BMI was 26 kg/m².

The researchers divided the total number of steps for each study participant into two groups: “bouted” steps, defined as 10 minutes or longer bouts of walking with few interruptions; and “sporadic” steps, defined as short spurts of walking during regular daily activities such as housework, taking the stairs, or walking to or from a car.

A total of 804 deaths occurred during an average of 6 years of follow-up. Each initial increase of 1,000 steps including sporadic or bouted steps was associated with a 28% decrease in death, compared with no daily steps (hazard ratio, 0.72).

Each increasing quartile of sporadic steps was linked with higher total steps per day, Mr. Moore said. “Initial increase in sporadic steps corresponded to the greatest reductions in mortality,” with a HR of 0.69 per additional sporadic steps below 3,200 per day, and the impact on reduced mortality plateaued at about 4,500 sporadic steps per day.

In further analysis, the researchers also found a roughly 32% decrease in death in participants who took more than 2,000 steps daily in uninterrupted bouts (HR, 0.69).

The study findings were limited by several factors, including the relatively short follow-up period and number of events, the assessment of steps at a single time point, and the mostly homogeneous population, Mr. Moore noted. Additional research is needed to assess whether the results are generalizable to men, younger women, and diverse racial and ethnic groups.

However, the results may have implications for public health messaging, he emphasized. The message is that, to impact longevity, the total volume of steps is more important than the type of activity through which they are accumulated.

“You can accumulate your steps through longer bouts of purposeful activity or through everyday behaviors such as walking to your car, taking the stairs, and doing housework,” Mr. Moore concluded.

Find a friend, both of you benefit

On the basis of this study and other available evidence, more steps daily are recommended for everyone, Nieca Goldberg, MD, a cardiologist at New York University Langone Health, said in an interview.

“You can increase minutes of walking and frequency of walking,” she said.

Dr. Goldberg emphasized that you don’t need a fancy app or wearable device to up your steps. She offered some tips to help overcome barriers to putting one foot in front of the other. “Take the steps instead of the elevator. Park your car farther from your destination so you can walk.” Also, you can help yourself and help a friend to better health. “Get a walking buddy so you can encourage each other to walk,” Dr. Goldberg added.

Mr. Moore and Dr. Goldberg had no financial conflicts to disclose. The Women’s Health Study is funded by Brigham and Women’s Hospital; the National Heart, Lung, and Blood Institute; and the National Cancer Institute. Mr. Moore was funded by a grant from the NHLBI but had no other financial conflicts to disclose.

Taking more steps each day, in short spurts or longer bouts, was associated with a longer life in women older than 60 years, according to data from more than 16,000 participants in the ongoing Women’s Health Study.

The American Heart Association recommends at least 150 minutes per week of moderate physical activity, 75 minutes of vigorous physical activity, or a combination of both as fitness guidelines for adults. Walking is a safe and easy way for many adults to follow these guidelines, according to Christopher C. Moore, MS, a PhD candidate at the University of North Carolina at Chapel Hill.

The popularity of step counts reflect that they are simple and objective, and “focusing on steps can help promote an active lifestyle,” he said. Data on the impact of sporadic steps accumulated outside of longer bouts of activity on health outcomes are limited; however, technology advances in the form of fitness apps and wearable devices make it possible for researchers to track and measure the benefits of short periods of activity as well as longer periods.

In a study presented at the Epidemiology and Prevention/Lifestyle and Cardiometabolic Health meeting, sponsored by the AHA, Mr. Moore and colleagues assessed data from women older than 60 years who used wearable step-counting devices to measure their daily steps and walking patterns.

The study population included 16,732 women enrolled in the Women’s Health Study, a longstanding study of heart disease, cancer, and disease prevention among women in the United States. The participants wore waist step counters 4-7 days a week during 2011-2015. The average of the women was 72 years; 96% were non-Hispanic White, and the average BMI was 26 kg/m².

The researchers divided the total number of steps for each study participant into two groups: “bouted” steps, defined as 10 minutes or longer bouts of walking with few interruptions; and “sporadic” steps, defined as short spurts of walking during regular daily activities such as housework, taking the stairs, or walking to or from a car.

A total of 804 deaths occurred during an average of 6 years of follow-up. Each initial increase of 1,000 steps including sporadic or bouted steps was associated with a 28% decrease in death, compared with no daily steps (hazard ratio, 0.72).

Each increasing quartile of sporadic steps was linked with higher total steps per day, Mr. Moore said. “Initial increase in sporadic steps corresponded to the greatest reductions in mortality,” with a HR of 0.69 per additional sporadic steps below 3,200 per day, and the impact on reduced mortality plateaued at about 4,500 sporadic steps per day.

In further analysis, the researchers also found a roughly 32% decrease in death in participants who took more than 2,000 steps daily in uninterrupted bouts (HR, 0.69).

The study findings were limited by several factors, including the relatively short follow-up period and number of events, the assessment of steps at a single time point, and the mostly homogeneous population, Mr. Moore noted. Additional research is needed to assess whether the results are generalizable to men, younger women, and diverse racial and ethnic groups.

However, the results may have implications for public health messaging, he emphasized. The message is that, to impact longevity, the total volume of steps is more important than the type of activity through which they are accumulated.

“You can accumulate your steps through longer bouts of purposeful activity or through everyday behaviors such as walking to your car, taking the stairs, and doing housework,” Mr. Moore concluded.

Find a friend, both of you benefit

On the basis of this study and other available evidence, more steps daily are recommended for everyone, Nieca Goldberg, MD, a cardiologist at New York University Langone Health, said in an interview.

“You can increase minutes of walking and frequency of walking,” she said.

Dr. Goldberg emphasized that you don’t need a fancy app or wearable device to up your steps. She offered some tips to help overcome barriers to putting one foot in front of the other. “Take the steps instead of the elevator. Park your car farther from your destination so you can walk.” Also, you can help yourself and help a friend to better health. “Get a walking buddy so you can encourage each other to walk,” Dr. Goldberg added.

Mr. Moore and Dr. Goldberg had no financial conflicts to disclose. The Women’s Health Study is funded by Brigham and Women’s Hospital; the National Heart, Lung, and Blood Institute; and the National Cancer Institute. Mr. Moore was funded by a grant from the NHLBI but had no other financial conflicts to disclose.

Obstetric patients whose first language is not English received fewer pain assessments and fewer doses of NSAIDs and oxycodone therapeutic equivalents (OTEs) following cesarean deliveries, according to a retrospective cohort study poster presented at the 2021 annual meeting of the American College of Obstetricians and Gynecologists.

The findings “may indicate language as a barrier for equitable pain management in the postpartum period,” concluded Alison Wiles, MD, a resident at Mount Sinai South Nassau in Oceanside, N.Y., and colleagues. They recommended “scheduled pain assessment and around the clock nonopioid medication administration” as potential ways to reduce the disparities.

“Racial and ethnic disparities in pain management have been well documented in both inpatient and outpatient settings, [and] similar disparities exist within postpartum pain management,” the researchers note in their background material. They also note that non-Hispanic White communities tend to have a higher incidence of opioid misuse.

The researchers conducted a retrospective study of 327 women who had cesarean deliveries from January to June 2018 at Mount Sinai South Nassau Hospital. They excluded women who underwent cesarean hysterectomies, received general anesthesia or patient-controlled analgesia, had a history of drug use, or had allergies to opiates. They did not note incidence of uterine fibroids, endometriosis, or other gynecologic conditions aside from delivery that could cause pain.

The population included a similar number of non-Hispanic White women (n = 111) and Hispanic women (n = 125). The remaining study participants included 32 non-Hispanic Black women and 59 women who were Asian or had another race/ethnicity. The women’s average age was 31, which was statistically similar across all four race/ethnicity groups. Average body mass index of participants was also similar, ranging from 32 to 34.6 kg/m², across all four demographic groups.

About half of all the women (52%) had a previous cesarean delivery, but rates were significantly different between groups: 31% of non-Hispanic Black women and 58% of Hispanic women had a prior cesarean, compared to 50% of non-Hispanic White, Asian, and other women (P < .05).

Half the women in the study overall (50.5%) had public insurance, but the proportion of those with public insurance differed significantly by racial/ethnic demographics. Less than a quarter of Asian/other women (23%) had public insurance, compared with 78% of Hispanic women, 74% of non-Hispanic White women, and 59% of non-Hispanic Black women (P < .0001).

Most of the women (76%) spoke English as their primary language, which included nearly all the women in each demographic group except Hispanic, in which 58% of the women’s primary language was Spanish or another language (P < .0001).

Hispanic patients received an average of 10 pain assessments after their cesarean, compared with an average of 11 in each of the other demographic groups (P = .02). Similarly, English speakers received an average 11 pain assessments, but those who primarily spoke Spanish or another language received 10 (P = .01).

The differences between English and non-English speakers were reflected in who received pain medication even though pain scores were the same between the two groups. English speakers received an average two doses of NSAIDs in the first 24 hours post partum, compared with one dose for those who spoke a primary language other than English (P = .03). At 24-48 hours post partum, those who spoke English received an average three NSAID doses, compared with two among those whose primary language was Spanish or another language (P = .03).

There was no difference between language groups in doses of OTEs in the first 24 hours post partum, but differences did occur on the second day. Women who primarily spoke English received an average four OTE doses in the 24-48 hours post partum, compared with two doses given to women who spoke a non-English primary language (P = .03).

Differences were less consistent or not significant when looking solely at race/ethnicity. All four groups received an average of two NSAID doses in the first 24 hours post partum, but second-day rates varied. Non-Hispanic White women and Asian/other women received an average three doses from 24 to 48 hours post partum while non-Hispanic Black women received one and Hispanic women received two (P = .0009).

No statistically significant differences in OTE doses occurred across the groups in the first 24 hours, but from 24 to 48 hours, the average two doses received by Hispanic women and 3 doses received by Asian women differed significantly from the average four doses received by non-Hispanic White women and the average five doses received by non-Hispanic Black women (P =.01).

“Non-Hispanic Black patients had higher OTE doses and fewer NSAID doses in the 24- to 48-hour postpartum period despite no differences in severe pain scores,” the authors also reported.

“These findings are surprising given the standardized protocols in place designed to assess and treat pain post partum,” Etoi A. Garrison, MD, PhD, an associate professor of maternal-fetal medicine at Vanderbilt University Medical Center, Memphis, Tenn., said in an interview. ” Protocols should minimize bias and promote equitable delivery of care.”

Dr. Garrison said it’s important to find out why these discrepancies exist even when ready access to interpretation services exist in the hospital.

“An important component of health care disparity research is to hear directly from patients themselves about their experiences,” Dr. Garrison said. “Often the patient voice is an overlooked and underappreciated resource. I hope that future iterations of this work include patient perceptions about the adequacy of postpartum care and provide more information about how health care delivery can be tailored to the unique needs of this vulnerable population.”

The authors reported no disclosures. Dr Garrison reported receiving a grant from the State of Tennessee Maternal Mortality Review Committee to Create an Unconscious Bias Faculty Train-the-Trainer Program.

Obstetric patients whose first language is not English received fewer pain assessments and fewer doses of NSAIDs and oxycodone therapeutic equivalents (OTEs) following cesarean deliveries, according to a retrospective cohort study poster presented at the 2021 annual meeting of the American College of Obstetricians and Gynecologists.

The findings “may indicate language as a barrier for equitable pain management in the postpartum period,” concluded Alison Wiles, MD, a resident at Mount Sinai South Nassau in Oceanside, N.Y., and colleagues. They recommended “scheduled pain assessment and around the clock nonopioid medication administration” as potential ways to reduce the disparities.

“Racial and ethnic disparities in pain management have been well documented in both inpatient and outpatient settings, [and] similar disparities exist within postpartum pain management,” the researchers note in their background material. They also note that non-Hispanic White communities tend to have a higher incidence of opioid misuse.

The researchers conducted a retrospective study of 327 women who had cesarean deliveries from January to June 2018 at Mount Sinai South Nassau Hospital. They excluded women who underwent cesarean hysterectomies, received general anesthesia or patient-controlled analgesia, had a history of drug use, or had allergies to opiates. They did not note incidence of uterine fibroids, endometriosis, or other gynecologic conditions aside from delivery that could cause pain.

The population included a similar number of non-Hispanic White women (n = 111) and Hispanic women (n = 125). The remaining study participants included 32 non-Hispanic Black women and 59 women who were Asian or had another race/ethnicity. The women’s average age was 31, which was statistically similar across all four race/ethnicity groups. Average body mass index of participants was also similar, ranging from 32 to 34.6 kg/m², across all four demographic groups.

About half of all the women (52%) had a previous cesarean delivery, but rates were significantly different between groups: 31% of non-Hispanic Black women and 58% of Hispanic women had a prior cesarean, compared to 50% of non-Hispanic White, Asian, and other women (P < .05).

Half the women in the study overall (50.5%) had public insurance, but the proportion of those with public insurance differed significantly by racial/ethnic demographics. Less than a quarter of Asian/other women (23%) had public insurance, compared with 78% of Hispanic women, 74% of non-Hispanic White women, and 59% of non-Hispanic Black women (P < .0001).

Most of the women (76%) spoke English as their primary language, which included nearly all the women in each demographic group except Hispanic, in which 58% of the women’s primary language was Spanish or another language (P < .0001).

Hispanic patients received an average of 10 pain assessments after their cesarean, compared with an average of 11 in each of the other demographic groups (P = .02). Similarly, English speakers received an average 11 pain assessments, but those who primarily spoke Spanish or another language received 10 (P = .01).

The differences between English and non-English speakers were reflected in who received pain medication even though pain scores were the same between the two groups. English speakers received an average two doses of NSAIDs in the first 24 hours post partum, compared with one dose for those who spoke a primary language other than English (P = .03). At 24-48 hours post partum, those who spoke English received an average three NSAID doses, compared with two among those whose primary language was Spanish or another language (P = .03).

There was no difference between language groups in doses of OTEs in the first 24 hours post partum, but differences did occur on the second day. Women who primarily spoke English received an average four OTE doses in the 24-48 hours post partum, compared with two doses given to women who spoke a non-English primary language (P = .03).

Differences were less consistent or not significant when looking solely at race/ethnicity. All four groups received an average of two NSAID doses in the first 24 hours post partum, but second-day rates varied. Non-Hispanic White women and Asian/other women received an average three doses from 24 to 48 hours post partum while non-Hispanic Black women received one and Hispanic women received two (P = .0009).

No statistically significant differences in OTE doses occurred across the groups in the first 24 hours, but from 24 to 48 hours, the average two doses received by Hispanic women and 3 doses received by Asian women differed significantly from the average four doses received by non-Hispanic White women and the average five doses received by non-Hispanic Black women (P =.01).

“Non-Hispanic Black patients had higher OTE doses and fewer NSAID doses in the 24- to 48-hour postpartum period despite no differences in severe pain scores,” the authors also reported.

“These findings are surprising given the standardized protocols in place designed to assess and treat pain post partum,” Etoi A. Garrison, MD, PhD, an associate professor of maternal-fetal medicine at Vanderbilt University Medical Center, Memphis, Tenn., said in an interview. ” Protocols should minimize bias and promote equitable delivery of care.”

Dr. Garrison said it’s important to find out why these discrepancies exist even when ready access to interpretation services exist in the hospital.

“An important component of health care disparity research is to hear directly from patients themselves about their experiences,” Dr. Garrison said. “Often the patient voice is an overlooked and underappreciated resource. I hope that future iterations of this work include patient perceptions about the adequacy of postpartum care and provide more information about how health care delivery can be tailored to the unique needs of this vulnerable population.”

The authors reported no disclosures. Dr Garrison reported receiving a grant from the State of Tennessee Maternal Mortality Review Committee to Create an Unconscious Bias Faculty Train-the-Trainer Program.

Obstetric patients whose first language is not English received fewer pain assessments and fewer doses of NSAIDs and oxycodone therapeutic equivalents (OTEs) following cesarean deliveries, according to a retrospective cohort study poster presented at the 2021 annual meeting of the American College of Obstetricians and Gynecologists.

The findings “may indicate language as a barrier for equitable pain management in the postpartum period,” concluded Alison Wiles, MD, a resident at Mount Sinai South Nassau in Oceanside, N.Y., and colleagues. They recommended “scheduled pain assessment and around the clock nonopioid medication administration” as potential ways to reduce the disparities.

“Racial and ethnic disparities in pain management have been well documented in both inpatient and outpatient settings, [and] similar disparities exist within postpartum pain management,” the researchers note in their background material. They also note that non-Hispanic White communities tend to have a higher incidence of opioid misuse.

The researchers conducted a retrospective study of 327 women who had cesarean deliveries from January to June 2018 at Mount Sinai South Nassau Hospital. They excluded women who underwent cesarean hysterectomies, received general anesthesia or patient-controlled analgesia, had a history of drug use, or had allergies to opiates. They did not note incidence of uterine fibroids, endometriosis, or other gynecologic conditions aside from delivery that could cause pain.

The population included a similar number of non-Hispanic White women (n = 111) and Hispanic women (n = 125). The remaining study participants included 32 non-Hispanic Black women and 59 women who were Asian or had another race/ethnicity. The women’s average age was 31, which was statistically similar across all four race/ethnicity groups. Average body mass index of participants was also similar, ranging from 32 to 34.6 kg/m², across all four demographic groups.

About half of all the women (52%) had a previous cesarean delivery, but rates were significantly different between groups: 31% of non-Hispanic Black women and 58% of Hispanic women had a prior cesarean, compared to 50% of non-Hispanic White, Asian, and other women (P < .05).

Half the women in the study overall (50.5%) had public insurance, but the proportion of those with public insurance differed significantly by racial/ethnic demographics. Less than a quarter of Asian/other women (23%) had public insurance, compared with 78% of Hispanic women, 74% of non-Hispanic White women, and 59% of non-Hispanic Black women (P < .0001).

Most of the women (76%) spoke English as their primary language, which included nearly all the women in each demographic group except Hispanic, in which 58% of the women’s primary language was Spanish or another language (P < .0001).

Hispanic patients received an average of 10 pain assessments after their cesarean, compared with an average of 11 in each of the other demographic groups (P = .02). Similarly, English speakers received an average 11 pain assessments, but those who primarily spoke Spanish or another language received 10 (P = .01).

The differences between English and non-English speakers were reflected in who received pain medication even though pain scores were the same between the two groups. English speakers received an average two doses of NSAIDs in the first 24 hours post partum, compared with one dose for those who spoke a primary language other than English (P = .03). At 24-48 hours post partum, those who spoke English received an average three NSAID doses, compared with two among those whose primary language was Spanish or another language (P = .03).

There was no difference between language groups in doses of OTEs in the first 24 hours post partum, but differences did occur on the second day. Women who primarily spoke English received an average four OTE doses in the 24-48 hours post partum, compared with two doses given to women who spoke a non-English primary language (P = .03).

Differences were less consistent or not significant when looking solely at race/ethnicity. All four groups received an average of two NSAID doses in the first 24 hours post partum, but second-day rates varied. Non-Hispanic White women and Asian/other women received an average three doses from 24 to 48 hours post partum while non-Hispanic Black women received one and Hispanic women received two (P = .0009).

No statistically significant differences in OTE doses occurred across the groups in the first 24 hours, but from 24 to 48 hours, the average two doses received by Hispanic women and 3 doses received by Asian women differed significantly from the average four doses received by non-Hispanic White women and the average five doses received by non-Hispanic Black women (P =.01).

“Non-Hispanic Black patients had higher OTE doses and fewer NSAID doses in the 24- to 48-hour postpartum period despite no differences in severe pain scores,” the authors also reported.

“These findings are surprising given the standardized protocols in place designed to assess and treat pain post partum,” Etoi A. Garrison, MD, PhD, an associate professor of maternal-fetal medicine at Vanderbilt University Medical Center, Memphis, Tenn., said in an interview. ” Protocols should minimize bias and promote equitable delivery of care.”

Dr. Garrison said it’s important to find out why these discrepancies exist even when ready access to interpretation services exist in the hospital.

“An important component of health care disparity research is to hear directly from patients themselves about their experiences,” Dr. Garrison said. “Often the patient voice is an overlooked and underappreciated resource. I hope that future iterations of this work include patient perceptions about the adequacy of postpartum care and provide more information about how health care delivery can be tailored to the unique needs of this vulnerable population.”

The authors reported no disclosures. Dr Garrison reported receiving a grant from the State of Tennessee Maternal Mortality Review Committee to Create an Unconscious Bias Faculty Train-the-Trainer Program.

The Food and Drug Administration has approved ibrexafungerp tablets (Brexafemme) as a 1-day oral therapy for vaginal yeast infections.

Ibrexafungerp is the first drug approved in a new antifungal class for vulvovaginal candidiasis (VVC) in more than 20 years, the drug’s manufacturer Scynexis said in a press release. It becomes the first and only nonazole treatment for vaginal yeast infections.

The biotechnology company said approval came after positive results from two phase 3 studies in which oral ibrexafungerp demonstrated efficacy and tolerability. The most common reactions observed in clinical trials were diarrhea, nausea, abdominal pain, dizziness, and vomiting.

There are few other treatments for vaginal yeast infections, which is the second most common cause of vaginitis. Those previously approved agents include several topical azole antifungals and oral fluconazole (Diflucan), which, Scynexis said, is the only other orally administered antifungal approved for the treatment of VVC in the United States and has  accounted for over more than 90% of prescriptions written for the condition each year.

However, the company noted, oral fluconazole reports a 55% therapeutic cure rate on its label, which now also includes warnings of potential fetal harm, demonstrating the need for new oral options.

The new drug may not fill that need for pregnant women, however, as the company noted that ibrexafungerp should not be used during pregnancy, and administration during pregnancy “may cause fetal harm based on animal studies.”

Because of possible teratogenic effects, the company advised clinicians to verify pregnancy status in females of reproductive potential before prescribing ibrexafungerp and advises effective contraception during treatment.

VVC can come with substantial morbidity, including genital pain, itching and burning, reduced sexual pleasure, and psychological distress.

David Angulo, MD, chief medical officer for Scynexis, said in a statement the tablets brings new benefits.

Dr. Angulo said the drug “has a differentiated fungicidal mechanism of action that kills a broad range of Candida species, including azole-resistant strains. We are working on completing our CANDLE study investigating ibrexafungerp for the prevention of recurrent VVC and expect we will be submitting a supplemental NDA [new drug application] in the first half of 2022.”

Scynexis said it partnered with Amplity Health, a Pennsylvania-based pharmaceutical company, to support U.S. marketing of the drug. The commercial launch will follow the approval.

Ibrexafungerp was granted approval through both the FDA’s Qualified Infectious Disease Product and Fast Track designations. It is expected to be marketed exclusively in the United States for 10 years.
 

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

The Food and Drug Administration has approved ibrexafungerp tablets (Brexafemme) as a 1-day oral therapy for vaginal yeast infections.

Ibrexafungerp is the first drug approved in a new antifungal class for vulvovaginal candidiasis (VVC) in more than 20 years, the drug’s manufacturer Scynexis said in a press release. It becomes the first and only nonazole treatment for vaginal yeast infections.

The biotechnology company said approval came after positive results from two phase 3 studies in which oral ibrexafungerp demonstrated efficacy and tolerability. The most common reactions observed in clinical trials were diarrhea, nausea, abdominal pain, dizziness, and vomiting.

There are few other treatments for vaginal yeast infections, which is the second most common cause of vaginitis. Those previously approved agents include several topical azole antifungals and oral fluconazole (Diflucan), which, Scynexis said, is the only other orally administered antifungal approved for the treatment of VVC in the United States and has  accounted for over more than 90% of prescriptions written for the condition each year.

However, the company noted, oral fluconazole reports a 55% therapeutic cure rate on its label, which now also includes warnings of potential fetal harm, demonstrating the need for new oral options.

The new drug may not fill that need for pregnant women, however, as the company noted that ibrexafungerp should not be used during pregnancy, and administration during pregnancy “may cause fetal harm based on animal studies.”

Because of possible teratogenic effects, the company advised clinicians to verify pregnancy status in females of reproductive potential before prescribing ibrexafungerp and advises effective contraception during treatment.

VVC can come with substantial morbidity, including genital pain, itching and burning, reduced sexual pleasure, and psychological distress.

David Angulo, MD, chief medical officer for Scynexis, said in a statement the tablets brings new benefits.

Dr. Angulo said the drug “has a differentiated fungicidal mechanism of action that kills a broad range of Candida species, including azole-resistant strains. We are working on completing our CANDLE study investigating ibrexafungerp for the prevention of recurrent VVC and expect we will be submitting a supplemental NDA [new drug application] in the first half of 2022.”

Scynexis said it partnered with Amplity Health, a Pennsylvania-based pharmaceutical company, to support U.S. marketing of the drug. The commercial launch will follow the approval.

Ibrexafungerp was granted approval through both the FDA’s Qualified Infectious Disease Product and Fast Track designations. It is expected to be marketed exclusively in the United States for 10 years.
 

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

The Food and Drug Administration has approved ibrexafungerp tablets (Brexafemme) as a 1-day oral therapy for vaginal yeast infections.

Ibrexafungerp is the first drug approved in a new antifungal class for vulvovaginal candidiasis (VVC) in more than 20 years, the drug’s manufacturer Scynexis said in a press release. It becomes the first and only nonazole treatment for vaginal yeast infections.

The biotechnology company said approval came after positive results from two phase 3 studies in which oral ibrexafungerp demonstrated efficacy and tolerability. The most common reactions observed in clinical trials were diarrhea, nausea, abdominal pain, dizziness, and vomiting.

There are few other treatments for vaginal yeast infections, which is the second most common cause of vaginitis. Those previously approved agents include several topical azole antifungals and oral fluconazole (Diflucan), which, Scynexis said, is the only other orally administered antifungal approved for the treatment of VVC in the United States and has  accounted for over more than 90% of prescriptions written for the condition each year.

However, the company noted, oral fluconazole reports a 55% therapeutic cure rate on its label, which now also includes warnings of potential fetal harm, demonstrating the need for new oral options.

The new drug may not fill that need for pregnant women, however, as the company noted that ibrexafungerp should not be used during pregnancy, and administration during pregnancy “may cause fetal harm based on animal studies.”

Because of possible teratogenic effects, the company advised clinicians to verify pregnancy status in females of reproductive potential before prescribing ibrexafungerp and advises effective contraception during treatment.

VVC can come with substantial morbidity, including genital pain, itching and burning, reduced sexual pleasure, and psychological distress.

David Angulo, MD, chief medical officer for Scynexis, said in a statement the tablets brings new benefits.

Dr. Angulo said the drug “has a differentiated fungicidal mechanism of action that kills a broad range of Candida species, including azole-resistant strains. We are working on completing our CANDLE study investigating ibrexafungerp for the prevention of recurrent VVC and expect we will be submitting a supplemental NDA [new drug application] in the first half of 2022.”

Scynexis said it partnered with Amplity Health, a Pennsylvania-based pharmaceutical company, to support U.S. marketing of the drug. The commercial launch will follow the approval.

Ibrexafungerp was granted approval through both the FDA’s Qualified Infectious Disease Product and Fast Track designations. It is expected to be marketed exclusively in the United States for 10 years.
 

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

Myocarditis is present in a small percentage of competitive athletes after COVID-19 infection, even in those without symptoms, new research suggests.

In a cohort study of 1,597 competitive collegiate athletes undergoing comprehensive cardiovascular testing in the United States, the prevalence of clinical myocarditis based on a symptom-based screening strategy was only 0.31%.

But screening with cardiac MRI increased the prevalence of clinical and subclinical myocarditis by a factor of 7.4, to 2.3%, the authors reported.

The findings are published online May 27, 2021, in JAMA Cardiology.

“It was the largest study to evaluate college athletes who have had COVID with extensive cardiac testing, including MRI, and this gave us a very objective look at the cardiac findings, as they were not purely based upon a subjective evaluation of symptoms,” lead investigator Curt J. Daniels, MD, professor at Ohio State University Wexner Medical Center, Columbus, said in an interview.

“Unfortunately, our study showed that athletes can be asymptomatic, or at least not report symptoms. This is a very subjective feature, and we don’t know if they don’t report symptoms because they didn’t want to get tested. That is why we took a very objective approach,” Dr. Daniels said.

The finding that more than half of the asymptomatic athletes had myocarditis, or as the investigators called it, “subclinical myocarditis,” was a surprise, he acknowledged.

“More than half of the athletes found to have myocarditis reported no symptoms, and yes, that was a surprise, because prior to this study, the protocols that had been published stated that you had to have symptoms to even enter into the protocol for cardiac MRI. But, as our ... paper shows, if we had followed that protocol, we only would have found about 5 cases of myocarditis, as opposed to the total of 37 we found with cardiac MRI,” Dr. Daniels said.

In October 2020, the American College of Cardiology’s Sports and Exercise Council recommended that cardiac MRI be limited to athletes who exhibited symptoms as part of their guide to ensuring a safe return to play.

As reported by this news organization the council recommended a tiered approach to screening based on the presence of symptoms, followed by electrocardiography, injury biomarkers, and echocardiography. Any abnormalities detected were to be further characterized by the selective use of cardiac MRI.

At the time, there were relatively few data to support the recommendations, and all stakeholders called for larger datasets to better drive informed recommendations in the future.

In the current study, Dr. Daniels and associates conducted comprehensive cardiac screening – including ECG, troponin testing, echocardiography, and cardiac MRI – of 1,597 college athlete survivors of COVID-19.

The athletes were part of the Big Ten athletic conference, which consists of 13 major American universities.

AlexLMX/Getty Images

Cardiac MRI revealed that 37 (2.3%) of these athletes demonstrated diagnostic criteria for COVID-19 myocarditis; of these, 20 had no cardiovascular symptoms and had normal ECGs, echocardiography, and troponin test results.

“These patients would not have been identified without CMR imaging. If we were going according to the older protocol, we would not have made this discovery. Cardiac MRI is the most sensitive and specific test for myocardial inflammation, there is no argument about that,” Dr. Daniels said.

The catch is, cardiac MRI is expensive and often difficult to access, especially in remote, rural, or other underserviced areas.

“You can’t get an MRI for every person who has had COVID, it’s just not feasible,” Dr. Daniels said. “We are not advocating that everybody get an MRI. But we do hope that our study creates awareness among clinicians and athletes themselves that if you’ve had COVID, even if you’re asymptomatic, there may be some heart changes. So be aware when you start to exercise again, if you have any symptoms, pause and seek medical care.”
 

Kudos to the sports cardiology community

In an accompanying editorial, James E. Udelson, MD, Ethan J. Rowin, MD, and Barry J. Maron, MD, from the CardioVascular Center at Tufts Medical Center, Boston, applauded the sports cardiology community for its diligence in acquiring and publishing data about the post–COVID-19 prevalence of cardiac abnormalities in competitive athletes.

“It is a real tribute to the sports cardiology community. There has been an amazing growth of information, and they not only gathered this information, they analyzed and published it, starting out with a study of 29 or 30 athletes, and now thousands,” Dr. Udelson said in an interview.

At the start of the pandemic, it appeared that 15%-20% of athletes had myocarditis, and athletic conferences were discussing canceling sports events.

However, with greater numbers comes a more accurate picture of the extent of the problem.

“Once you get thousands of subjects in these studies, you can hone in on what the real number is, so now we understand that if you screen everybody with a cardiac MRI, 1%, 2%, or 3% will have some evidence of what looks like myocarditis,” he said.

Dr. Udelson agreed that doing cardiac imaging in everyone is not feasible.

“This study looked at a very large number of people who all had an MRI, but that doesn’t mean everyone should have them. If you just do an echo, an EKG, and a troponin test, and if everything is normal, which is kind of what current recommendations are, this paper tells us that we are going to miss one or two people out of a hundred, and that might be okay,” he said. “So, if you are at a huge university that has a large medical center and you want to screen all your athletes with MRI, great. But if you’re at a high school in a remote area, you know that the alternative, not having an MRI, isn’t so bad, either.”

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

Myocarditis is present in a small percentage of competitive athletes after COVID-19 infection, even in those without symptoms, new research suggests.

In a cohort study of 1,597 competitive collegiate athletes undergoing comprehensive cardiovascular testing in the United States, the prevalence of clinical myocarditis based on a symptom-based screening strategy was only 0.31%.

But screening with cardiac MRI increased the prevalence of clinical and subclinical myocarditis by a factor of 7.4, to 2.3%, the authors reported.

The findings are published online May 27, 2021, in JAMA Cardiology.

“It was the largest study to evaluate college athletes who have had COVID with extensive cardiac testing, including MRI, and this gave us a very objective look at the cardiac findings, as they were not purely based upon a subjective evaluation of symptoms,” lead investigator Curt J. Daniels, MD, professor at Ohio State University Wexner Medical Center, Columbus, said in an interview.

“Unfortunately, our study showed that athletes can be asymptomatic, or at least not report symptoms. This is a very subjective feature, and we don’t know if they don’t report symptoms because they didn’t want to get tested. That is why we took a very objective approach,” Dr. Daniels said.

The finding that more than half of the asymptomatic athletes had myocarditis, or as the investigators called it, “subclinical myocarditis,” was a surprise, he acknowledged.

“More than half of the athletes found to have myocarditis reported no symptoms, and yes, that was a surprise, because prior to this study, the protocols that had been published stated that you had to have symptoms to even enter into the protocol for cardiac MRI. But, as our ... paper shows, if we had followed that protocol, we only would have found about 5 cases of myocarditis, as opposed to the total of 37 we found with cardiac MRI,” Dr. Daniels said.

In October 2020, the American College of Cardiology’s Sports and Exercise Council recommended that cardiac MRI be limited to athletes who exhibited symptoms as part of their guide to ensuring a safe return to play.

As reported by this news organization the council recommended a tiered approach to screening based on the presence of symptoms, followed by electrocardiography, injury biomarkers, and echocardiography. Any abnormalities detected were to be further characterized by the selective use of cardiac MRI.

At the time, there were relatively few data to support the recommendations, and all stakeholders called for larger datasets to better drive informed recommendations in the future.

In the current study, Dr. Daniels and associates conducted comprehensive cardiac screening – including ECG, troponin testing, echocardiography, and cardiac MRI – of 1,597 college athlete survivors of COVID-19.

The athletes were part of the Big Ten athletic conference, which consists of 13 major American universities.

AlexLMX/Getty Images

Cardiac MRI revealed that 37 (2.3%) of these athletes demonstrated diagnostic criteria for COVID-19 myocarditis; of these, 20 had no cardiovascular symptoms and had normal ECGs, echocardiography, and troponin test results.

“These patients would not have been identified without CMR imaging. If we were going according to the older protocol, we would not have made this discovery. Cardiac MRI is the most sensitive and specific test for myocardial inflammation, there is no argument about that,” Dr. Daniels said.

The catch is, cardiac MRI is expensive and often difficult to access, especially in remote, rural, or other underserviced areas.

“You can’t get an MRI for every person who has had COVID, it’s just not feasible,” Dr. Daniels said. “We are not advocating that everybody get an MRI. But we do hope that our study creates awareness among clinicians and athletes themselves that if you’ve had COVID, even if you’re asymptomatic, there may be some heart changes. So be aware when you start to exercise again, if you have any symptoms, pause and seek medical care.”
 

Kudos to the sports cardiology community

In an accompanying editorial, James E. Udelson, MD, Ethan J. Rowin, MD, and Barry J. Maron, MD, from the CardioVascular Center at Tufts Medical Center, Boston, applauded the sports cardiology community for its diligence in acquiring and publishing data about the post–COVID-19 prevalence of cardiac abnormalities in competitive athletes.

“It is a real tribute to the sports cardiology community. There has been an amazing growth of information, and they not only gathered this information, they analyzed and published it, starting out with a study of 29 or 30 athletes, and now thousands,” Dr. Udelson said in an interview.

At the start of the pandemic, it appeared that 15%-20% of athletes had myocarditis, and athletic conferences were discussing canceling sports events.

However, with greater numbers comes a more accurate picture of the extent of the problem.

“Once you get thousands of subjects in these studies, you can hone in on what the real number is, so now we understand that if you screen everybody with a cardiac MRI, 1%, 2%, or 3% will have some evidence of what looks like myocarditis,” he said.

Dr. Udelson agreed that doing cardiac imaging in everyone is not feasible.

“This study looked at a very large number of people who all had an MRI, but that doesn’t mean everyone should have them. If you just do an echo, an EKG, and a troponin test, and if everything is normal, which is kind of what current recommendations are, this paper tells us that we are going to miss one or two people out of a hundred, and that might be okay,” he said. “So, if you are at a huge university that has a large medical center and you want to screen all your athletes with MRI, great. But if you’re at a high school in a remote area, you know that the alternative, not having an MRI, isn’t so bad, either.”

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

Myocarditis is present in a small percentage of competitive athletes after COVID-19 infection, even in those without symptoms, new research suggests.

In a cohort study of 1,597 competitive collegiate athletes undergoing comprehensive cardiovascular testing in the United States, the prevalence of clinical myocarditis based on a symptom-based screening strategy was only 0.31%.

But screening with cardiac MRI increased the prevalence of clinical and subclinical myocarditis by a factor of 7.4, to 2.3%, the authors reported.

The findings are published online May 27, 2021, in JAMA Cardiology.

“It was the largest study to evaluate college athletes who have had COVID with extensive cardiac testing, including MRI, and this gave us a very objective look at the cardiac findings, as they were not purely based upon a subjective evaluation of symptoms,” lead investigator Curt J. Daniels, MD, professor at Ohio State University Wexner Medical Center, Columbus, said in an interview.

“Unfortunately, our study showed that athletes can be asymptomatic, or at least not report symptoms. This is a very subjective feature, and we don’t know if they don’t report symptoms because they didn’t want to get tested. That is why we took a very objective approach,” Dr. Daniels said.

The finding that more than half of the asymptomatic athletes had myocarditis, or as the investigators called it, “subclinical myocarditis,” was a surprise, he acknowledged.

“More than half of the athletes found to have myocarditis reported no symptoms, and yes, that was a surprise, because prior to this study, the protocols that had been published stated that you had to have symptoms to even enter into the protocol for cardiac MRI. But, as our ... paper shows, if we had followed that protocol, we only would have found about 5 cases of myocarditis, as opposed to the total of 37 we found with cardiac MRI,” Dr. Daniels said.

In October 2020, the American College of Cardiology’s Sports and Exercise Council recommended that cardiac MRI be limited to athletes who exhibited symptoms as part of their guide to ensuring a safe return to play.

As reported by this news organization the council recommended a tiered approach to screening based on the presence of symptoms, followed by electrocardiography, injury biomarkers, and echocardiography. Any abnormalities detected were to be further characterized by the selective use of cardiac MRI.

At the time, there were relatively few data to support the recommendations, and all stakeholders called for larger datasets to better drive informed recommendations in the future.

In the current study, Dr. Daniels and associates conducted comprehensive cardiac screening – including ECG, troponin testing, echocardiography, and cardiac MRI – of 1,597 college athlete survivors of COVID-19.

The athletes were part of the Big Ten athletic conference, which consists of 13 major American universities.

AlexLMX/Getty Images

Cardiac MRI revealed that 37 (2.3%) of these athletes demonstrated diagnostic criteria for COVID-19 myocarditis; of these, 20 had no cardiovascular symptoms and had normal ECGs, echocardiography, and troponin test results.

“These patients would not have been identified without CMR imaging. If we were going according to the older protocol, we would not have made this discovery. Cardiac MRI is the most sensitive and specific test for myocardial inflammation, there is no argument about that,” Dr. Daniels said.

The catch is, cardiac MRI is expensive and often difficult to access, especially in remote, rural, or other underserviced areas.

“You can’t get an MRI for every person who has had COVID, it’s just not feasible,” Dr. Daniels said. “We are not advocating that everybody get an MRI. But we do hope that our study creates awareness among clinicians and athletes themselves that if you’ve had COVID, even if you’re asymptomatic, there may be some heart changes. So be aware when you start to exercise again, if you have any symptoms, pause and seek medical care.”
 

Kudos to the sports cardiology community

In an accompanying editorial, James E. Udelson, MD, Ethan J. Rowin, MD, and Barry J. Maron, MD, from the CardioVascular Center at Tufts Medical Center, Boston, applauded the sports cardiology community for its diligence in acquiring and publishing data about the post–COVID-19 prevalence of cardiac abnormalities in competitive athletes.

“It is a real tribute to the sports cardiology community. There has been an amazing growth of information, and they not only gathered this information, they analyzed and published it, starting out with a study of 29 or 30 athletes, and now thousands,” Dr. Udelson said in an interview.

At the start of the pandemic, it appeared that 15%-20% of athletes had myocarditis, and athletic conferences were discussing canceling sports events.

However, with greater numbers comes a more accurate picture of the extent of the problem.

“Once you get thousands of subjects in these studies, you can hone in on what the real number is, so now we understand that if you screen everybody with a cardiac MRI, 1%, 2%, or 3% will have some evidence of what looks like myocarditis,” he said.

Dr. Udelson agreed that doing cardiac imaging in everyone is not feasible.

“This study looked at a very large number of people who all had an MRI, but that doesn’t mean everyone should have them. If you just do an echo, an EKG, and a troponin test, and if everything is normal, which is kind of what current recommendations are, this paper tells us that we are going to miss one or two people out of a hundred, and that might be okay,” he said. “So, if you are at a huge university that has a large medical center and you want to screen all your athletes with MRI, great. But if you’re at a high school in a remote area, you know that the alternative, not having an MRI, isn’t so bad, either.”

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

The U.S. Department of Justice (DOJ) on May 26 announced charges against 14 defendants across the country who allegedly engaged in health care fraud schemes that exploited the COVID-19 pandemic and resulted in over $143 million in false billings to Medicare.

Among the defendants, a DOJ news release said, were a telemedicine company executive, a physician, marketers, and medical business owners.

In addition, the Centers for Medicare and Medicaid Services separately announced that it had taken “adverse administrative actions” against more than 50 providers for their involvement in fraud schemes related to COVID-19 or the abuse of CMS programs that were designed to encourage access to medical care during the pandemic.

Several of the defendants allegedly offered COVID-19 tests to Medicare beneficiaries in senior living facilities, drive-through COVID-19 testing sites, and medical offices to induce the beneficiaries to provide their personal identifying information and a saliva or a blood sample.

The DOJ charges claim the defendants then misused the information and the samples to submit claims to Medicare for unrelated, medically unnecessary, and far more expensive lab tests, including cancer genetic testing, allergy testing, and respiratory pathogen panel tests.

In some cases, it’s alleged, the lab results were not provided to the individuals in a timely fashion or were not reliable.

Other defendants are charged with exploiting temporary changes in CMS telehealth regulations that were designed to increase access to health care during the pandemic. In these cases, which the DOJ said were the first charges related to the expansion of telehealth under the COVID-19 emergency declaration, the defendants allegedly submitted false and fraudulent claims to Medicare for sham telemedicine encounters that did not occur.

“As part of these cases, medical professionals are alleged to have [been] offered and paid bribes in exchange for the medical professionals’ referral of unnecessary testing,” the DOJ news release said. However, no physicians were identified by the department.

Commenting on this aspect of the law enforcement action, FBI Director Christopher Wray said in the release: “Medical providers have been the unsung heroes for the American public throughout the pandemic. It’s disheartening that some have abused their authorities and committed COVID-19–related fraud against trusting citizens. The FBI, along with our federal law enforcement and private sector partners, are committed to continuing to combat health care fraud and protect the American people.”

The law enforcement action includes the third set of criminal charges related to the misuse of Provider Relief Fund monies, according to the release.

More than 340 individuals were charged in September 2020 with submitting $6 billion in fraudulent claims to federal health care programs and private insurers for telehealth consultations and substance abuse treatment. About $4.5 billion of that was related to telehealth, as reported by this news organization.

The new criminal charges were brought in federal district courts in Arkansas, California, Louisiana, Florida, New Jersey, and New York.
 

Case summaries

The DOJ provided several case summaries. One defendant, lab owner Billy Joe Taylor of Lavaca, Ark., was charged with participating in a scheme to defraud the government of over $42 million by filing false claims that were billed in combination with COVID-19 testing claims. He also allegedly billed for tests that were not performed.

Petros Hannesyan of Burbank, Calif., the owner of a home health agency, was charged with obtaining over $229,000 from COVID-19 relief programs under false pretenses. His firm allegedly misappropriated funds from the CARES Act Provider Relief Fund and submitted false loan applications and a false loan agreement to the Economic Injury Disaster Loan Program.

Michael Stein and Leonel Palatnik of Palm Beach County, Fla., were charged in a connection with an alleged $73 million conspiracy to defraud the government and to pay and receive health care kickbacks during the pandemic.

Mr. Stein, who owned a “purported” consulting company, and Mr. Palatnik, who owned testing labs in Texas, allegedly exploited Medicare’s waiver of telehealth restrictions “by offering telehealth providers access to Medicare beneficiaries for whom they could bill consultations. In exchange, these providers agreed to refer beneficiaries to [Mr. Palatnik’s] laboratories for expensive and medically unnecessary cancer and cardiovascular genetic testing.”
 

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

The U.S. Department of Justice (DOJ) on May 26 announced charges against 14 defendants across the country who allegedly engaged in health care fraud schemes that exploited the COVID-19 pandemic and resulted in over $143 million in false billings to Medicare.

Among the defendants, a DOJ news release said, were a telemedicine company executive, a physician, marketers, and medical business owners.

In addition, the Centers for Medicare and Medicaid Services separately announced that it had taken “adverse administrative actions” against more than 50 providers for their involvement in fraud schemes related to COVID-19 or the abuse of CMS programs that were designed to encourage access to medical care during the pandemic.

Several of the defendants allegedly offered COVID-19 tests to Medicare beneficiaries in senior living facilities, drive-through COVID-19 testing sites, and medical offices to induce the beneficiaries to provide their personal identifying information and a saliva or a blood sample.

The DOJ charges claim the defendants then misused the information and the samples to submit claims to Medicare for unrelated, medically unnecessary, and far more expensive lab tests, including cancer genetic testing, allergy testing, and respiratory pathogen panel tests.

In some cases, it’s alleged, the lab results were not provided to the individuals in a timely fashion or were not reliable.

Other defendants are charged with exploiting temporary changes in CMS telehealth regulations that were designed to increase access to health care during the pandemic. In these cases, which the DOJ said were the first charges related to the expansion of telehealth under the COVID-19 emergency declaration, the defendants allegedly submitted false and fraudulent claims to Medicare for sham telemedicine encounters that did not occur.

“As part of these cases, medical professionals are alleged to have [been] offered and paid bribes in exchange for the medical professionals’ referral of unnecessary testing,” the DOJ news release said. However, no physicians were identified by the department.

Commenting on this aspect of the law enforcement action, FBI Director Christopher Wray said in the release: “Medical providers have been the unsung heroes for the American public throughout the pandemic. It’s disheartening that some have abused their authorities and committed COVID-19–related fraud against trusting citizens. The FBI, along with our federal law enforcement and private sector partners, are committed to continuing to combat health care fraud and protect the American people.”

The law enforcement action includes the third set of criminal charges related to the misuse of Provider Relief Fund monies, according to the release.

More than 340 individuals were charged in September 2020 with submitting $6 billion in fraudulent claims to federal health care programs and private insurers for telehealth consultations and substance abuse treatment. About $4.5 billion of that was related to telehealth, as reported by this news organization.

The new criminal charges were brought in federal district courts in Arkansas, California, Louisiana, Florida, New Jersey, and New York.
 

Case summaries

The DOJ provided several case summaries. One defendant, lab owner Billy Joe Taylor of Lavaca, Ark., was charged with participating in a scheme to defraud the government of over $42 million by filing false claims that were billed in combination with COVID-19 testing claims. He also allegedly billed for tests that were not performed.

Petros Hannesyan of Burbank, Calif., the owner of a home health agency, was charged with obtaining over $229,000 from COVID-19 relief programs under false pretenses. His firm allegedly misappropriated funds from the CARES Act Provider Relief Fund and submitted false loan applications and a false loan agreement to the Economic Injury Disaster Loan Program.

Michael Stein and Leonel Palatnik of Palm Beach County, Fla., were charged in a connection with an alleged $73 million conspiracy to defraud the government and to pay and receive health care kickbacks during the pandemic.

Mr. Stein, who owned a “purported” consulting company, and Mr. Palatnik, who owned testing labs in Texas, allegedly exploited Medicare’s waiver of telehealth restrictions “by offering telehealth providers access to Medicare beneficiaries for whom they could bill consultations. In exchange, these providers agreed to refer beneficiaries to [Mr. Palatnik’s] laboratories for expensive and medically unnecessary cancer and cardiovascular genetic testing.”
 

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

The U.S. Department of Justice (DOJ) on May 26 announced charges against 14 defendants across the country who allegedly engaged in health care fraud schemes that exploited the COVID-19 pandemic and resulted in over $143 million in false billings to Medicare.

Among the defendants, a DOJ news release said, were a telemedicine company executive, a physician, marketers, and medical business owners.

In addition, the Centers for Medicare and Medicaid Services separately announced that it had taken “adverse administrative actions” against more than 50 providers for their involvement in fraud schemes related to COVID-19 or the abuse of CMS programs that were designed to encourage access to medical care during the pandemic.

Several of the defendants allegedly offered COVID-19 tests to Medicare beneficiaries in senior living facilities, drive-through COVID-19 testing sites, and medical offices to induce the beneficiaries to provide their personal identifying information and a saliva or a blood sample.

The DOJ charges claim the defendants then misused the information and the samples to submit claims to Medicare for unrelated, medically unnecessary, and far more expensive lab tests, including cancer genetic testing, allergy testing, and respiratory pathogen panel tests.

In some cases, it’s alleged, the lab results were not provided to the individuals in a timely fashion or were not reliable.

Other defendants are charged with exploiting temporary changes in CMS telehealth regulations that were designed to increase access to health care during the pandemic. In these cases, which the DOJ said were the first charges related to the expansion of telehealth under the COVID-19 emergency declaration, the defendants allegedly submitted false and fraudulent claims to Medicare for sham telemedicine encounters that did not occur.

“As part of these cases, medical professionals are alleged to have [been] offered and paid bribes in exchange for the medical professionals’ referral of unnecessary testing,” the DOJ news release said. However, no physicians were identified by the department.

Commenting on this aspect of the law enforcement action, FBI Director Christopher Wray said in the release: “Medical providers have been the unsung heroes for the American public throughout the pandemic. It’s disheartening that some have abused their authorities and committed COVID-19–related fraud against trusting citizens. The FBI, along with our federal law enforcement and private sector partners, are committed to continuing to combat health care fraud and protect the American people.”

The law enforcement action includes the third set of criminal charges related to the misuse of Provider Relief Fund monies, according to the release.

More than 340 individuals were charged in September 2020 with submitting $6 billion in fraudulent claims to federal health care programs and private insurers for telehealth consultations and substance abuse treatment. About $4.5 billion of that was related to telehealth, as reported by this news organization.

The new criminal charges were brought in federal district courts in Arkansas, California, Louisiana, Florida, New Jersey, and New York.
 

Case summaries

The DOJ provided several case summaries. One defendant, lab owner Billy Joe Taylor of Lavaca, Ark., was charged with participating in a scheme to defraud the government of over $42 million by filing false claims that were billed in combination with COVID-19 testing claims. He also allegedly billed for tests that were not performed.

Petros Hannesyan of Burbank, Calif., the owner of a home health agency, was charged with obtaining over $229,000 from COVID-19 relief programs under false pretenses. His firm allegedly misappropriated funds from the CARES Act Provider Relief Fund and submitted false loan applications and a false loan agreement to the Economic Injury Disaster Loan Program.

Michael Stein and Leonel Palatnik of Palm Beach County, Fla., were charged in a connection with an alleged $73 million conspiracy to defraud the government and to pay and receive health care kickbacks during the pandemic.

Mr. Stein, who owned a “purported” consulting company, and Mr. Palatnik, who owned testing labs in Texas, allegedly exploited Medicare’s waiver of telehealth restrictions “by offering telehealth providers access to Medicare beneficiaries for whom they could bill consultations. In exchange, these providers agreed to refer beneficiaries to [Mr. Palatnik’s] laboratories for expensive and medically unnecessary cancer and cardiovascular genetic testing.”
 

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

Researchers are trying to understand how e-cigarette use affects pregnancy and birth outcomes. This question may become more relevant as younger vapers, among whom the devices gained considerable popularity, start having children.

Limited emerging data from animal experiments and human epidemiologic studies suggest that vaping may have negative effects on fertility and pregnancy. “Even if these impacts are less severe than conventional smoking, we really should be thinking about alternate options that may be safer for our patients than inhalation of this aerosol,” said Blair J. Wylie, MD, MPH, a maternal-fetal medicine physician at Beth Israel Deaconess Medical Center in Boston.

Dr. Wylie reviewed what is known about vaping, including chemicals other than nicotine that have been detected in vape aerosols, and pregnancy at the 2021 virtual meeting of the American College of Obstetricians and Gynecologists.

“There’s a lot we don’t know,” she said. “These products were only introduced recently, in 2003. They are marketed aggressively to our youth and have gained tremendous popularity among that population. And it’s only a matter of time, I think, before we see a lot of use in our own patient population.”

In a separate study presented at the ACOG meeting, Nicole Izhakoff, a researcher at Florida International University, Miami, and colleagues evaluated the association between e-cigarette use during pregnancy and unfavorable birth outcomes, such as preterm birth, low birth weight, or extended hospital stay for the newborn.

The investigators used 2016-2017 survey data from the Pregnancy Risk Assessment Monitoring System. In all, 71,940 women completed the survey, including 859 who reported e-cigarette use during pregnancy.

After adjusting for age, race, ethnicity, insurance, maternal education, prenatal care, abuse during pregnancy, and complications during pregnancy, the researchers estimated that the odds of an unfavorable birth outcome were 62% greater among women who used e-cigarettes during pregnancy, compared with those who did not.

The researchers lacked information about simultaneous use of alcohol, traditional tobacco, or other drugs, however.

“Physicians of all subspecialties, especially those of obstetrics-gynecology and pediatrics, need to increase the implementation of screening for past or current e-cigarette use in at-risk patients,” Ms. Izhakoff and coauthors concluded. “Further research regarding the long-term health effects of e-cigarettes is warranted.”

Dr. Wylie coauthored another study related to this topic that was published online May 24, 2021, in the Journal of Maternal-Fetal & Neonatal Medicine.

The researchers examined birth weights of children whose mothers use e-cigarettes alone, those whose mothers used both e-cigarettes and conventional cigarettes, and those whose mothers smoked conventional cigarettes only. Their estimates were imprecise, but signaled that e-cigarette use may reduce birth weight. The use of e-cigarettes alone appeared to have less of an impact on birth weight than the dual use of conventional cigarettes and e-cigarettes did.

Dr. Wylie cautioned that outcomes like birth weight are “pretty crude measures of whether an exposure is okay or not in pregnancy. Many of these toxins that we know that are in the aerosols can cause harm, but they may not be reflected in the absolute value of the birth weight.”

In addition, clinicians should avoid focusing on the wrong question when caring for patients.

“I think the wrong question is: Is vaping safer than smoking?” Dr. Wylie said in an interview. “Metals are going into your lungs. Plastics are going into your lungs. It is hard for me to think that we are going to identify that as our champion smoking cessation strategy in pregnancy.”
 

Rapidly changing landscape

Answering the question of which is safer is a challenge anyway because researchers likely have incomplete information about who vapes, who smokes, and who does both.

Still, the new research illustrates that “people are starting to think about this and beginning to do some analysis that is really hypothesis generating at this point,” Dr. Wylie said. Such studies may prompt clinicians to ask their patients about e-cigarette use. “Marijuana is sort of a similar thing where patients’ perception of safety, because things are legal, can lead to use during pregnancy without ... letting their care teams know,” she said. “Things are changing so rapidly in terms of what’s available to people to use that we need to stay on top of that as obstetricians and ask the right questions and try to understand what the risks are and potential benefits.”

Dr. Wylie is an obstetric consultant to the New England Pediatric Environmental Health Specialty Unit, which is where she heard pediatricians discussing widespread e-cigarette use among youth. It occurred to her that some of these teens eventually would be seeing obstetricians. She also saw parallels to prior research she conducted that focused on household air pollution or cooking from wood-burning fires in Africa.

“What is frightening, I think, about these electronic cigarettes is that you’re heating this liquid to extraordinarily high temperatures to create the vapor,” and the extreme heat vaporizes plastics and metals as well as nicotine, Dr. Wylie said.

An ACOG committee opinion discusses approaches to smoking and vaping cessation such as counseling, behavioral therapy, and medication.

The publication also lists a host of elements have been isolated from vape aerosol, including “carbonyl compounds (formaldehyde, acetaldehyde, acetone, and acrolein); volatile organic compounds (benzene and toluene); nitrosamines; particulate matter; and heavy metals such as copper, lead, zinc, and tin.”

In addition to the nicotine in e-cigarette liquids, which is harmful in itself, there is “all of this other company that it keeps,” including solvent byproducts, known carcinogens, and lung irritants, Dr. Wylie said. Fine particulate matter “can land in the small airways and cause inflammation, even translocate into the systemic circulation and cause systemic inflammation.”

The use of flavoring “likely alters perceptions of harm” and contributes to the popularity of vaping, Dr. Wylie noted. At the same time, the use of flavoring also has little regulatory oversight. Flavors usually are approved for marketing based on safety for ingestion, but that may not translate into safety for inhalation.
 

Parsing the health effects

People who vape have increased cough, wheezing, and phlegm production, compared with people who do not vape. Vaping also may worsen underlying lung disease like asthma. Lung function on spirometry decreases after e-cigarette use, studies have shown.

In 2019, researchers described e-cigarette or vaping product use–related acute lung injury (EVALI), which has caused more than 60 deaths in the United States. The condition may be related to vitamin E acetate, a component that had been used in some liquids used by patients with EVALI.

And the nicotine in e-cigarettes can accelerate atherogenesis and affect blood pressure, heart rate, and arterial stiffness.

Initially introduced as a smoking cessation tool, e-cigarettes now often are used on their own or in addition to cigarettes, rather than strictly for smoking cessation.

A Cochrane review suggests that e-cigarettes may be more effective than other approaches to smoking cessation. But “the effect is modest at best,” Dr. Wylie said. Among 100 people attempting to quit cigarette smoking, there might four to six more quitters with the use of e-cigarettes as a smoking cessation intervention, compared with other approaches.

Animal models provide other reasons for caution. One experiment in mice showed that exposure to e-cigarette aerosol impaired implantation and fetal health. The results suggest “that there might be some negative impacts across generations,” Dr. Wylie said.

Another study has suggested the possibility that women who currently use e-cigarettes may have slightly diminished fecundability. The results were not statistically significant, but the study “gives us pause about whether there could be some impact on early pregnancy and fertility,” Dr. Wylie said.

In mouse models, prenatal exposure to e-cigarette aerosol has decreased fetal weight and length, altered neurodevelopment and neuroregulatory gene expression, and increased proinflammatory cytokines. E-cigarette aerosol also has caused birth defects in zebrafish and facial clefting in frogs. Whether and how these data relate to human pregnancy is unclear.

While e-cigarette ads may convey a sense of style and harmlessness, clinicians have reasons to worry about the effects. “We have to be a little bit more cautious when we are talking about this with our patients,” Dr. Wylie said.

Dr. Wylie had no relevant financial disclosures. She is a Society for Maternal-Fetal Medicine board member and receives grant support related to research of household air pollution and pregnancy, prenatal pesticide exposure, preeclampsia in low income settings, and malaria during pregnancy. Ms. Izhakoff and coauthors had no disclosures.

[email protected]

Researchers are trying to understand how e-cigarette use affects pregnancy and birth outcomes. This question may become more relevant as younger vapers, among whom the devices gained considerable popularity, start having children.

Limited emerging data from animal experiments and human epidemiologic studies suggest that vaping may have negative effects on fertility and pregnancy. “Even if these impacts are less severe than conventional smoking, we really should be thinking about alternate options that may be safer for our patients than inhalation of this aerosol,” said Blair J. Wylie, MD, MPH, a maternal-fetal medicine physician at Beth Israel Deaconess Medical Center in Boston.

Dr. Wylie reviewed what is known about vaping, including chemicals other than nicotine that have been detected in vape aerosols, and pregnancy at the 2021 virtual meeting of the American College of Obstetricians and Gynecologists.

“There’s a lot we don’t know,” she said. “These products were only introduced recently, in 2003. They are marketed aggressively to our youth and have gained tremendous popularity among that population. And it’s only a matter of time, I think, before we see a lot of use in our own patient population.”

In a separate study presented at the ACOG meeting, Nicole Izhakoff, a researcher at Florida International University, Miami, and colleagues evaluated the association between e-cigarette use during pregnancy and unfavorable birth outcomes, such as preterm birth, low birth weight, or extended hospital stay for the newborn.

The investigators used 2016-2017 survey data from the Pregnancy Risk Assessment Monitoring System. In all, 71,940 women completed the survey, including 859 who reported e-cigarette use during pregnancy.

After adjusting for age, race, ethnicity, insurance, maternal education, prenatal care, abuse during pregnancy, and complications during pregnancy, the researchers estimated that the odds of an unfavorable birth outcome were 62% greater among women who used e-cigarettes during pregnancy, compared with those who did not.

The researchers lacked information about simultaneous use of alcohol, traditional tobacco, or other drugs, however.

“Physicians of all subspecialties, especially those of obstetrics-gynecology and pediatrics, need to increase the implementation of screening for past or current e-cigarette use in at-risk patients,” Ms. Izhakoff and coauthors concluded. “Further research regarding the long-term health effects of e-cigarettes is warranted.”

Dr. Wylie coauthored another study related to this topic that was published online May 24, 2021, in the Journal of Maternal-Fetal & Neonatal Medicine.

The researchers examined birth weights of children whose mothers use e-cigarettes alone, those whose mothers used both e-cigarettes and conventional cigarettes, and those whose mothers smoked conventional cigarettes only. Their estimates were imprecise, but signaled that e-cigarette use may reduce birth weight. The use of e-cigarettes alone appeared to have less of an impact on birth weight than the dual use of conventional cigarettes and e-cigarettes did.

Dr. Wylie cautioned that outcomes like birth weight are “pretty crude measures of whether an exposure is okay or not in pregnancy. Many of these toxins that we know that are in the aerosols can cause harm, but they may not be reflected in the absolute value of the birth weight.”

In addition, clinicians should avoid focusing on the wrong question when caring for patients.

“I think the wrong question is: Is vaping safer than smoking?” Dr. Wylie said in an interview. “Metals are going into your lungs. Plastics are going into your lungs. It is hard for me to think that we are going to identify that as our champion smoking cessation strategy in pregnancy.”
 

Rapidly changing landscape

Answering the question of which is safer is a challenge anyway because researchers likely have incomplete information about who vapes, who smokes, and who does both.

Still, the new research illustrates that “people are starting to think about this and beginning to do some analysis that is really hypothesis generating at this point,” Dr. Wylie said. Such studies may prompt clinicians to ask their patients about e-cigarette use. “Marijuana is sort of a similar thing where patients’ perception of safety, because things are legal, can lead to use during pregnancy without ... letting their care teams know,” she said. “Things are changing so rapidly in terms of what’s available to people to use that we need to stay on top of that as obstetricians and ask the right questions and try to understand what the risks are and potential benefits.”

Dr. Wylie is an obstetric consultant to the New England Pediatric Environmental Health Specialty Unit, which is where she heard pediatricians discussing widespread e-cigarette use among youth. It occurred to her that some of these teens eventually would be seeing obstetricians. She also saw parallels to prior research she conducted that focused on household air pollution or cooking from wood-burning fires in Africa.

“What is frightening, I think, about these electronic cigarettes is that you’re heating this liquid to extraordinarily high temperatures to create the vapor,” and the extreme heat vaporizes plastics and metals as well as nicotine, Dr. Wylie said.

An ACOG committee opinion discusses approaches to smoking and vaping cessation such as counseling, behavioral therapy, and medication.

The publication also lists a host of elements have been isolated from vape aerosol, including “carbonyl compounds (formaldehyde, acetaldehyde, acetone, and acrolein); volatile organic compounds (benzene and toluene); nitrosamines; particulate matter; and heavy metals such as copper, lead, zinc, and tin.”

In addition to the nicotine in e-cigarette liquids, which is harmful in itself, there is “all of this other company that it keeps,” including solvent byproducts, known carcinogens, and lung irritants, Dr. Wylie said. Fine particulate matter “can land in the small airways and cause inflammation, even translocate into the systemic circulation and cause systemic inflammation.”

The use of flavoring “likely alters perceptions of harm” and contributes to the popularity of vaping, Dr. Wylie noted. At the same time, the use of flavoring also has little regulatory oversight. Flavors usually are approved for marketing based on safety for ingestion, but that may not translate into safety for inhalation.
 

Parsing the health effects

People who vape have increased cough, wheezing, and phlegm production, compared with people who do not vape. Vaping also may worsen underlying lung disease like asthma. Lung function on spirometry decreases after e-cigarette use, studies have shown.

In 2019, researchers described e-cigarette or vaping product use–related acute lung injury (EVALI), which has caused more than 60 deaths in the United States. The condition may be related to vitamin E acetate, a component that had been used in some liquids used by patients with EVALI.

And the nicotine in e-cigarettes can accelerate atherogenesis and affect blood pressure, heart rate, and arterial stiffness.

Initially introduced as a smoking cessation tool, e-cigarettes now often are used on their own or in addition to cigarettes, rather than strictly for smoking cessation.

A Cochrane review suggests that e-cigarettes may be more effective than other approaches to smoking cessation. But “the effect is modest at best,” Dr. Wylie said. Among 100 people attempting to quit cigarette smoking, there might four to six more quitters with the use of e-cigarettes as a smoking cessation intervention, compared with other approaches.

Animal models provide other reasons for caution. One experiment in mice showed that exposure to e-cigarette aerosol impaired implantation and fetal health. The results suggest “that there might be some negative impacts across generations,” Dr. Wylie said.

Another study has suggested the possibility that women who currently use e-cigarettes may have slightly diminished fecundability. The results were not statistically significant, but the study “gives us pause about whether there could be some impact on early pregnancy and fertility,” Dr. Wylie said.

In mouse models, prenatal exposure to e-cigarette aerosol has decreased fetal weight and length, altered neurodevelopment and neuroregulatory gene expression, and increased proinflammatory cytokines. E-cigarette aerosol also has caused birth defects in zebrafish and facial clefting in frogs. Whether and how these data relate to human pregnancy is unclear.

While e-cigarette ads may convey a sense of style and harmlessness, clinicians have reasons to worry about the effects. “We have to be a little bit more cautious when we are talking about this with our patients,” Dr. Wylie said.

Dr. Wylie had no relevant financial disclosures. She is a Society for Maternal-Fetal Medicine board member and receives grant support related to research of household air pollution and pregnancy, prenatal pesticide exposure, preeclampsia in low income settings, and malaria during pregnancy. Ms. Izhakoff and coauthors had no disclosures.

[email protected]

Researchers are trying to understand how e-cigarette use affects pregnancy and birth outcomes. This question may become more relevant as younger vapers, among whom the devices gained considerable popularity, start having children.

Limited emerging data from animal experiments and human epidemiologic studies suggest that vaping may have negative effects on fertility and pregnancy. “Even if these impacts are less severe than conventional smoking, we really should be thinking about alternate options that may be safer for our patients than inhalation of this aerosol,” said Blair J. Wylie, MD, MPH, a maternal-fetal medicine physician at Beth Israel Deaconess Medical Center in Boston.

Dr. Wylie reviewed what is known about vaping, including chemicals other than nicotine that have been detected in vape aerosols, and pregnancy at the 2021 virtual meeting of the American College of Obstetricians and Gynecologists.

“There’s a lot we don’t know,” she said. “These products were only introduced recently, in 2003. They are marketed aggressively to our youth and have gained tremendous popularity among that population. And it’s only a matter of time, I think, before we see a lot of use in our own patient population.”

In a separate study presented at the ACOG meeting, Nicole Izhakoff, a researcher at Florida International University, Miami, and colleagues evaluated the association between e-cigarette use during pregnancy and unfavorable birth outcomes, such as preterm birth, low birth weight, or extended hospital stay for the newborn.

The investigators used 2016-2017 survey data from the Pregnancy Risk Assessment Monitoring System. In all, 71,940 women completed the survey, including 859 who reported e-cigarette use during pregnancy.

After adjusting for age, race, ethnicity, insurance, maternal education, prenatal care, abuse during pregnancy, and complications during pregnancy, the researchers estimated that the odds of an unfavorable birth outcome were 62% greater among women who used e-cigarettes during pregnancy, compared with those who did not.

The researchers lacked information about simultaneous use of alcohol, traditional tobacco, or other drugs, however.

“Physicians of all subspecialties, especially those of obstetrics-gynecology and pediatrics, need to increase the implementation of screening for past or current e-cigarette use in at-risk patients,” Ms. Izhakoff and coauthors concluded. “Further research regarding the long-term health effects of e-cigarettes is warranted.”

Dr. Wylie coauthored another study related to this topic that was published online May 24, 2021, in the Journal of Maternal-Fetal & Neonatal Medicine.

The researchers examined birth weights of children whose mothers use e-cigarettes alone, those whose mothers used both e-cigarettes and conventional cigarettes, and those whose mothers smoked conventional cigarettes only. Their estimates were imprecise, but signaled that e-cigarette use may reduce birth weight. The use of e-cigarettes alone appeared to have less of an impact on birth weight than the dual use of conventional cigarettes and e-cigarettes did.

Dr. Wylie cautioned that outcomes like birth weight are “pretty crude measures of whether an exposure is okay or not in pregnancy. Many of these toxins that we know that are in the aerosols can cause harm, but they may not be reflected in the absolute value of the birth weight.”

In addition, clinicians should avoid focusing on the wrong question when caring for patients.

“I think the wrong question is: Is vaping safer than smoking?” Dr. Wylie said in an interview. “Metals are going into your lungs. Plastics are going into your lungs. It is hard for me to think that we are going to identify that as our champion smoking cessation strategy in pregnancy.”
 

Rapidly changing landscape

Answering the question of which is safer is a challenge anyway because researchers likely have incomplete information about who vapes, who smokes, and who does both.

Still, the new research illustrates that “people are starting to think about this and beginning to do some analysis that is really hypothesis generating at this point,” Dr. Wylie said. Such studies may prompt clinicians to ask their patients about e-cigarette use. “Marijuana is sort of a similar thing where patients’ perception of safety, because things are legal, can lead to use during pregnancy without ... letting their care teams know,” she said. “Things are changing so rapidly in terms of what’s available to people to use that we need to stay on top of that as obstetricians and ask the right questions and try to understand what the risks are and potential benefits.”

Dr. Wylie is an obstetric consultant to the New England Pediatric Environmental Health Specialty Unit, which is where she heard pediatricians discussing widespread e-cigarette use among youth. It occurred to her that some of these teens eventually would be seeing obstetricians. She also saw parallels to prior research she conducted that focused on household air pollution or cooking from wood-burning fires in Africa.

“What is frightening, I think, about these electronic cigarettes is that you’re heating this liquid to extraordinarily high temperatures to create the vapor,” and the extreme heat vaporizes plastics and metals as well as nicotine, Dr. Wylie said.

An ACOG committee opinion discusses approaches to smoking and vaping cessation such as counseling, behavioral therapy, and medication.

The publication also lists a host of elements have been isolated from vape aerosol, including “carbonyl compounds (formaldehyde, acetaldehyde, acetone, and acrolein); volatile organic compounds (benzene and toluene); nitrosamines; particulate matter; and heavy metals such as copper, lead, zinc, and tin.”

In addition to the nicotine in e-cigarette liquids, which is harmful in itself, there is “all of this other company that it keeps,” including solvent byproducts, known carcinogens, and lung irritants, Dr. Wylie said. Fine particulate matter “can land in the small airways and cause inflammation, even translocate into the systemic circulation and cause systemic inflammation.”

The use of flavoring “likely alters perceptions of harm” and contributes to the popularity of vaping, Dr. Wylie noted. At the same time, the use of flavoring also has little regulatory oversight. Flavors usually are approved for marketing based on safety for ingestion, but that may not translate into safety for inhalation.
 

Parsing the health effects

People who vape have increased cough, wheezing, and phlegm production, compared with people who do not vape. Vaping also may worsen underlying lung disease like asthma. Lung function on spirometry decreases after e-cigarette use, studies have shown.

In 2019, researchers described e-cigarette or vaping product use–related acute lung injury (EVALI), which has caused more than 60 deaths in the United States. The condition may be related to vitamin E acetate, a component that had been used in some liquids used by patients with EVALI.

And the nicotine in e-cigarettes can accelerate atherogenesis and affect blood pressure, heart rate, and arterial stiffness.

Initially introduced as a smoking cessation tool, e-cigarettes now often are used on their own or in addition to cigarettes, rather than strictly for smoking cessation.

A Cochrane review suggests that e-cigarettes may be more effective than other approaches to smoking cessation. But “the effect is modest at best,” Dr. Wylie said. Among 100 people attempting to quit cigarette smoking, there might four to six more quitters with the use of e-cigarettes as a smoking cessation intervention, compared with other approaches.

Animal models provide other reasons for caution. One experiment in mice showed that exposure to e-cigarette aerosol impaired implantation and fetal health. The results suggest “that there might be some negative impacts across generations,” Dr. Wylie said.

Another study has suggested the possibility that women who currently use e-cigarettes may have slightly diminished fecundability. The results were not statistically significant, but the study “gives us pause about whether there could be some impact on early pregnancy and fertility,” Dr. Wylie said.

In mouse models, prenatal exposure to e-cigarette aerosol has decreased fetal weight and length, altered neurodevelopment and neuroregulatory gene expression, and increased proinflammatory cytokines. E-cigarette aerosol also has caused birth defects in zebrafish and facial clefting in frogs. Whether and how these data relate to human pregnancy is unclear.

While e-cigarette ads may convey a sense of style and harmlessness, clinicians have reasons to worry about the effects. “We have to be a little bit more cautious when we are talking about this with our patients,” Dr. Wylie said.

Dr. Wylie had no relevant financial disclosures. She is a Society for Maternal-Fetal Medicine board member and receives grant support related to research of household air pollution and pregnancy, prenatal pesticide exposure, preeclampsia in low income settings, and malaria during pregnancy. Ms. Izhakoff and coauthors had no disclosures.

[email protected]

Fewer doctors are opting to run their own small private practices, with more seeking jobs in hospitals or larger medical groups, according to a new report.

These patterns likely reflect broader trends toward consolidation in health care, with both insurance companies and hospitals also having grown in size in recent years.

The latest biennial analysis of doctors’ practices by the American Medical Association showed an acceleration of a trend away from private practice, defined as a practice wholly owned by physicians. The 2020 results found less than half – 49.1 % – of doctors involved in patient care worked in a private practice, the AMA said in a report released in May 2021.

This marked the first time private practice was not the dominant approach since the AMA analysis began in 2012. What’s more, the trend appears to be gaining steam, with a drop of almost 5 percentage points from 54.0% in private practice in 2018. The percent of doctors in private practice declined at a slower rate in previous AMA surveys, slipping to 55.8% in 2016 from 56.8% in 2018 and 60.1% in 2012.

Employment and ownership structures have become so varied that no single approach or size of organization “can or should be considered the typical physician practice,” the report noted.

The AMA, for example, added to its 2020 benchmark survey an option to identify private equity organizations as employers. The survey found 4% of doctors involved in patient care worked in practices owned by these kinds of firms. Other options include practices wholly or jointly owned by hospital and health systems and insurers, as well as direct employment and contracting.

There are signs that the shift away from smaller private practices will continue, with younger doctors appearing more likely to seek employment.

The survey found 42% of doctors ages 55 and older were employed by someone else, compared with 51.2% of doctors ages 40-54 and 70% of physicians under the age of 40.

The AMA surveyed 3,500 U.S. doctors through the 2020 Physician Practice Benchmark Survey. The survey was conducted from September to October 2020, roughly 6 months into the COVID-19 pandemic, and therefore may not reflect its full impact.

“Physician practices were hit hard by the economic impact of the early pandemic as patient volume and revenues shrank while medical supply expenses spiked. The impact of these economic forces on physician practice arrangements is ongoing and may not be fully realized for some time,” AMA President Susan R. Bailey, MD, said in a statement.

In a survey released in 2020 by McKinsey & Company, 53% of independent doctors reported that they were worried about their practices surviving the stresses of the pandemic, this news organization reported.
 

Challenging environment

It’s not just money leading to the shift away from private practice, according to a 2020 report from the American Hospital Association, titled “Evolving Physician-Practice Ownership Models.”

Many recent graduates of medical schools have significant debt and are more likely to opt for employment, which offers more financial stability and work-life balance, the report said.

Doctors also need to keep up with expectations of their patients that have been shaped by advances in other sectors, like banking, the AHA noted. People are used to working on their own schedules, and want to make appointments through apps, get test results rapidly and on their mobile devices, and communicate with their providers virtually.

“It is challenging to meet these expectations and make the necessary technology investments as a solo or small group practice,” the AHA report said.

Hospitals face competition for doctors from insurers, which have been looking in some cases to directly employ more physicians, the AHA also noted. The report cites insurance giant UnitedHealth Group’s Optum unit as the most visible example of this trend.

On a January call about corporate earnings, David Wichmann, then chief executive of UnitedHealth, spoke about the firm’s “aim to reinvent health care delivery,” including efforts to have its own primary and multispecialty care practices.

“OptumCare entered 2021 with over 50,000 physicians and 1,400 clinics,” Mr. Wichmann said. “Over the course of this year, we expect to grow our employed and affiliated physicians by at least 10,000. This work of building local physician-led systems of care continues to be central to our mission. “

UnitedHealth’s new CEO is Andrew Witty, who had led the Optum unit.
 

Attractions of larger groups

Older doctors – those 55 years and up – were significantly more likely to work in small practices than those younger than 40, the 2020 survey found. Results showed 40.9% of doctors under 40 worked in practices of 10 or fewer colleagues, compared with 61.4% of those age 55 and older.

The large difference between age groups suggests that attrition is one reason for the shift in practice size. Retiring doctors who leave small practices are not being replaced on a one-for-one basis by younger doctors, AMA said. The same reason also appears to be a factor in the shift in practice ownership to larger systems.

Doctors in larger group practices can count on a stable business model, with a better ability to survive disruptive market trends, including those of a more extreme nature, like COVID-19, said Fred Horton, president of AMGA Consulting.

AMGA Consulting is a wholly-owned subsidiary of AMGA, formerly called American Medical Group Association. Its more than 400 members include well-known multispecialty groups and health care systems such as the Mayo Clinic, Cleveland Clinic, Geisinger, the Permanente Medical Group, and Intermountain Healthcare as well as many smaller physician practices.

Mr. Horton, who holds a master’s degree in health administration, said some doctors may want to participate in alternative payment programs offered by insurers, who are seeking to shift away from the fee-for-service model

“Larger organizations can dedicate more resources to continuous quality improvement,” Mr. Horton said. “This is especially important for physicians who are taking on risk-based contracts, as quality can directly impact how much they earn.”

For one oncologist, it was turning to alternative payment methods that helped him keep his private practice afloat.

Kashyap Patel, MD, chief executive of the Carolina Blood and Cancer Care Associates in Rock Hill, S.C., said he maintained the independence of his practice amid pressure from a large health system, which had been buying medical groups in the area. That began to interfere with referrals of patients from other doctors, which are key for cancer specialists, said Dr. Patel, who also is president of the Community Oncology Alliance.

In response, Dr. Patel worked with Blue Cross Blue Shield of South Carolina on an arrangement where his practice sought certifications from the National Committee for Quality Assurance to get better rates.

The effort has allowed Dr. Patel’s clinic to focus more on preventing hospitalizations and visits to the emergency room he said.

In Dr. Patel’s view, his patients benefit from his efforts to remain in independent practice. A switch to ownership by a large health care organization would have put them at risk for higher medical bills, jeopardizing their access to treatment, he said. The reason? Hospitals can charge more for services provided by doctors they employ.

“Nothing would change. I would be the same. The building would be the same, but the cost would go up,” Dr. Patel said.

For its part, the AHA has repeatedly challenged arguments that acquisitions and mergers result in higher costs for patients.

Instead, the AHA has raised alarms about consolidation of health insurers, a concern it shares with AMA. In a 2020 report examining competition among insurers, AMA noted doctors working in small practices can be put at a disadvantage if mergers and acquisitions leave an insurer with too much market power.

“Under antitrust law, independent physicians cannot negotiate collectively with health

Insurers,” the AMA said in the report. “This imbalance in relative size leaves most physicians with a weak bargaining position relative to commercial payers.”

AMA’s research on the effects of insurers’ wielding significant market clout has been used in effort to thwart mergers in this industry.
 

‘Dramatic restructuring’

The Federal Trade Commission also has taken note of the trends discussed in the new AMA report, saying that “U.S. physician markets are undergoing a dramatic restructuring.”

The FTC in January announced a study of the impact of the consolidation of doctors groups and health care facilities. FTC is seeking data for inpatient, outpatient, and doctors services in 15 states from 2015 through 2020. To gather this data, the commission has issued orders to six major insurers – Aetna, Anthem, Florida Blue, Cigna, Health Care Service Corporation and United Healthcare.

The FTC is concerned that acquired practices may have to alter their referral patterns to favor their affiliated hospital system over competing hospital systems. But FTC staff also said it might be that these acquisitions result in efficiencies, such as enhanced coordination of care between doctors and hospitals “that outweigh potential competitive harms.”

The research project will likely take several years to complete because of its scope, the FTC said. For that reason, the FTC said its Bureau of Economics will release a series of research papers examining different aspects of this inquiry rather than a single paper containing all of the analyses.
 

Private equity ‘roll-ups’

On the day the FTC announced the study of the impact of doctors groups, one of the panel’s commissioners argued for a closer look at how private equity firms make their purchases.

In a Jan. 15 tweet, FTC Commissioner Rohit Chopra said his agency needs to challenge their “roll-ups of small physician practices” as well as clinics and labs. This is a practice of using a series of acquisitions too small to trigger the federal threshold for a serious look from the FTC and Department of Justice. (The threshold for 2021 stands around the $92 million mark. This benchmark is known as Hart-Scott-Rodino notification after a 1976 law that set a reporting standard.)

Mr. Chopra attached to his Jan. 15 tweet a 2020 statement in which he called for stepped-up scrutiny of private-equity firms’ acquisitions of doctors’ practices. Mr. Chopra noted that private-equity firms have been buying practices focused on anesthesiology and emergency medicine, fields which triggered consumer complaints about surprise billing for emergency care.

“Given trends in today’s markets, it is critical that the FTC find new ways to ensure the agency has a rigorous, data-driven approach to market monitoring and enforcement,” Mr. Chopra wrote.

A version of this article first appeared on WebMD.com.

Fewer doctors are opting to run their own small private practices, with more seeking jobs in hospitals or larger medical groups, according to a new report.

These patterns likely reflect broader trends toward consolidation in health care, with both insurance companies and hospitals also having grown in size in recent years.

The latest biennial analysis of doctors’ practices by the American Medical Association showed an acceleration of a trend away from private practice, defined as a practice wholly owned by physicians. The 2020 results found less than half – 49.1 % – of doctors involved in patient care worked in a private practice, the AMA said in a report released in May 2021.

This marked the first time private practice was not the dominant approach since the AMA analysis began in 2012. What’s more, the trend appears to be gaining steam, with a drop of almost 5 percentage points from 54.0% in private practice in 2018. The percent of doctors in private practice declined at a slower rate in previous AMA surveys, slipping to 55.8% in 2016 from 56.8% in 2018 and 60.1% in 2012.

Employment and ownership structures have become so varied that no single approach or size of organization “can or should be considered the typical physician practice,” the report noted.

The AMA, for example, added to its 2020 benchmark survey an option to identify private equity organizations as employers. The survey found 4% of doctors involved in patient care worked in practices owned by these kinds of firms. Other options include practices wholly or jointly owned by hospital and health systems and insurers, as well as direct employment and contracting.

There are signs that the shift away from smaller private practices will continue, with younger doctors appearing more likely to seek employment.

The survey found 42% of doctors ages 55 and older were employed by someone else, compared with 51.2% of doctors ages 40-54 and 70% of physicians under the age of 40.

The AMA surveyed 3,500 U.S. doctors through the 2020 Physician Practice Benchmark Survey. The survey was conducted from September to October 2020, roughly 6 months into the COVID-19 pandemic, and therefore may not reflect its full impact.

“Physician practices were hit hard by the economic impact of the early pandemic as patient volume and revenues shrank while medical supply expenses spiked. The impact of these economic forces on physician practice arrangements is ongoing and may not be fully realized for some time,” AMA President Susan R. Bailey, MD, said in a statement.

In a survey released in 2020 by McKinsey & Company, 53% of independent doctors reported that they were worried about their practices surviving the stresses of the pandemic, this news organization reported.
 

Challenging environment

It’s not just money leading to the shift away from private practice, according to a 2020 report from the American Hospital Association, titled “Evolving Physician-Practice Ownership Models.”

Many recent graduates of medical schools have significant debt and are more likely to opt for employment, which offers more financial stability and work-life balance, the report said.

Doctors also need to keep up with expectations of their patients that have been shaped by advances in other sectors, like banking, the AHA noted. People are used to working on their own schedules, and want to make appointments through apps, get test results rapidly and on their mobile devices, and communicate with their providers virtually.

“It is challenging to meet these expectations and make the necessary technology investments as a solo or small group practice,” the AHA report said.

Hospitals face competition for doctors from insurers, which have been looking in some cases to directly employ more physicians, the AHA also noted. The report cites insurance giant UnitedHealth Group’s Optum unit as the most visible example of this trend.

On a January call about corporate earnings, David Wichmann, then chief executive of UnitedHealth, spoke about the firm’s “aim to reinvent health care delivery,” including efforts to have its own primary and multispecialty care practices.

“OptumCare entered 2021 with over 50,000 physicians and 1,400 clinics,” Mr. Wichmann said. “Over the course of this year, we expect to grow our employed and affiliated physicians by at least 10,000. This work of building local physician-led systems of care continues to be central to our mission. “

UnitedHealth’s new CEO is Andrew Witty, who had led the Optum unit.
 

Attractions of larger groups

Older doctors – those 55 years and up – were significantly more likely to work in small practices than those younger than 40, the 2020 survey found. Results showed 40.9% of doctors under 40 worked in practices of 10 or fewer colleagues, compared with 61.4% of those age 55 and older.

The large difference between age groups suggests that attrition is one reason for the shift in practice size. Retiring doctors who leave small practices are not being replaced on a one-for-one basis by younger doctors, AMA said. The same reason also appears to be a factor in the shift in practice ownership to larger systems.

Doctors in larger group practices can count on a stable business model, with a better ability to survive disruptive market trends, including those of a more extreme nature, like COVID-19, said Fred Horton, president of AMGA Consulting.

AMGA Consulting is a wholly-owned subsidiary of AMGA, formerly called American Medical Group Association. Its more than 400 members include well-known multispecialty groups and health care systems such as the Mayo Clinic, Cleveland Clinic, Geisinger, the Permanente Medical Group, and Intermountain Healthcare as well as many smaller physician practices.

Mr. Horton, who holds a master’s degree in health administration, said some doctors may want to participate in alternative payment programs offered by insurers, who are seeking to shift away from the fee-for-service model

“Larger organizations can dedicate more resources to continuous quality improvement,” Mr. Horton said. “This is especially important for physicians who are taking on risk-based contracts, as quality can directly impact how much they earn.”

For one oncologist, it was turning to alternative payment methods that helped him keep his private practice afloat.

Kashyap Patel, MD, chief executive of the Carolina Blood and Cancer Care Associates in Rock Hill, S.C., said he maintained the independence of his practice amid pressure from a large health system, which had been buying medical groups in the area. That began to interfere with referrals of patients from other doctors, which are key for cancer specialists, said Dr. Patel, who also is president of the Community Oncology Alliance.

In response, Dr. Patel worked with Blue Cross Blue Shield of South Carolina on an arrangement where his practice sought certifications from the National Committee for Quality Assurance to get better rates.

The effort has allowed Dr. Patel’s clinic to focus more on preventing hospitalizations and visits to the emergency room he said.

In Dr. Patel’s view, his patients benefit from his efforts to remain in independent practice. A switch to ownership by a large health care organization would have put them at risk for higher medical bills, jeopardizing their access to treatment, he said. The reason? Hospitals can charge more for services provided by doctors they employ.

“Nothing would change. I would be the same. The building would be the same, but the cost would go up,” Dr. Patel said.

For its part, the AHA has repeatedly challenged arguments that acquisitions and mergers result in higher costs for patients.

Instead, the AHA has raised alarms about consolidation of health insurers, a concern it shares with AMA. In a 2020 report examining competition among insurers, AMA noted doctors working in small practices can be put at a disadvantage if mergers and acquisitions leave an insurer with too much market power.

“Under antitrust law, independent physicians cannot negotiate collectively with health

Insurers,” the AMA said in the report. “This imbalance in relative size leaves most physicians with a weak bargaining position relative to commercial payers.”

AMA’s research on the effects of insurers’ wielding significant market clout has been used in effort to thwart mergers in this industry.
 

‘Dramatic restructuring’

The Federal Trade Commission also has taken note of the trends discussed in the new AMA report, saying that “U.S. physician markets are undergoing a dramatic restructuring.”

The FTC in January announced a study of the impact of the consolidation of doctors groups and health care facilities. FTC is seeking data for inpatient, outpatient, and doctors services in 15 states from 2015 through 2020. To gather this data, the commission has issued orders to six major insurers – Aetna, Anthem, Florida Blue, Cigna, Health Care Service Corporation and United Healthcare.

The FTC is concerned that acquired practices may have to alter their referral patterns to favor their affiliated hospital system over competing hospital systems. But FTC staff also said it might be that these acquisitions result in efficiencies, such as enhanced coordination of care between doctors and hospitals “that outweigh potential competitive harms.”

The research project will likely take several years to complete because of its scope, the FTC said. For that reason, the FTC said its Bureau of Economics will release a series of research papers examining different aspects of this inquiry rather than a single paper containing all of the analyses.
 

Private equity ‘roll-ups’

On the day the FTC announced the study of the impact of doctors groups, one of the panel’s commissioners argued for a closer look at how private equity firms make their purchases.

In a Jan. 15 tweet, FTC Commissioner Rohit Chopra said his agency needs to challenge their “roll-ups of small physician practices” as well as clinics and labs. This is a practice of using a series of acquisitions too small to trigger the federal threshold for a serious look from the FTC and Department of Justice. (The threshold for 2021 stands around the $92 million mark. This benchmark is known as Hart-Scott-Rodino notification after a 1976 law that set a reporting standard.)

Mr. Chopra attached to his Jan. 15 tweet a 2020 statement in which he called for stepped-up scrutiny of private-equity firms’ acquisitions of doctors’ practices. Mr. Chopra noted that private-equity firms have been buying practices focused on anesthesiology and emergency medicine, fields which triggered consumer complaints about surprise billing for emergency care.

“Given trends in today’s markets, it is critical that the FTC find new ways to ensure the agency has a rigorous, data-driven approach to market monitoring and enforcement,” Mr. Chopra wrote.

A version of this article first appeared on WebMD.com.

Fewer doctors are opting to run their own small private practices, with more seeking jobs in hospitals or larger medical groups, according to a new report.

These patterns likely reflect broader trends toward consolidation in health care, with both insurance companies and hospitals also having grown in size in recent years.

The latest biennial analysis of doctors’ practices by the American Medical Association showed an acceleration of a trend away from private practice, defined as a practice wholly owned by physicians. The 2020 results found less than half – 49.1 % – of doctors involved in patient care worked in a private practice, the AMA said in a report released in May 2021.

This marked the first time private practice was not the dominant approach since the AMA analysis began in 2012. What’s more, the trend appears to be gaining steam, with a drop of almost 5 percentage points from 54.0% in private practice in 2018. The percent of doctors in private practice declined at a slower rate in previous AMA surveys, slipping to 55.8% in 2016 from 56.8% in 2018 and 60.1% in 2012.

Employment and ownership structures have become so varied that no single approach or size of organization “can or should be considered the typical physician practice,” the report noted.

The AMA, for example, added to its 2020 benchmark survey an option to identify private equity organizations as employers. The survey found 4% of doctors involved in patient care worked in practices owned by these kinds of firms. Other options include practices wholly or jointly owned by hospital and health systems and insurers, as well as direct employment and contracting.

There are signs that the shift away from smaller private practices will continue, with younger doctors appearing more likely to seek employment.

The survey found 42% of doctors ages 55 and older were employed by someone else, compared with 51.2% of doctors ages 40-54 and 70% of physicians under the age of 40.

The AMA surveyed 3,500 U.S. doctors through the 2020 Physician Practice Benchmark Survey. The survey was conducted from September to October 2020, roughly 6 months into the COVID-19 pandemic, and therefore may not reflect its full impact.

“Physician practices were hit hard by the economic impact of the early pandemic as patient volume and revenues shrank while medical supply expenses spiked. The impact of these economic forces on physician practice arrangements is ongoing and may not be fully realized for some time,” AMA President Susan R. Bailey, MD, said in a statement.

In a survey released in 2020 by McKinsey & Company, 53% of independent doctors reported that they were worried about their practices surviving the stresses of the pandemic, this news organization reported.
 

Challenging environment

It’s not just money leading to the shift away from private practice, according to a 2020 report from the American Hospital Association, titled “Evolving Physician-Practice Ownership Models.”

Many recent graduates of medical schools have significant debt and are more likely to opt for employment, which offers more financial stability and work-life balance, the report said.

Doctors also need to keep up with expectations of their patients that have been shaped by advances in other sectors, like banking, the AHA noted. People are used to working on their own schedules, and want to make appointments through apps, get test results rapidly and on their mobile devices, and communicate with their providers virtually.

“It is challenging to meet these expectations and make the necessary technology investments as a solo or small group practice,” the AHA report said.

Hospitals face competition for doctors from insurers, which have been looking in some cases to directly employ more physicians, the AHA also noted. The report cites insurance giant UnitedHealth Group’s Optum unit as the most visible example of this trend.

On a January call about corporate earnings, David Wichmann, then chief executive of UnitedHealth, spoke about the firm’s “aim to reinvent health care delivery,” including efforts to have its own primary and multispecialty care practices.

“OptumCare entered 2021 with over 50,000 physicians and 1,400 clinics,” Mr. Wichmann said. “Over the course of this year, we expect to grow our employed and affiliated physicians by at least 10,000. This work of building local physician-led systems of care continues to be central to our mission. “

UnitedHealth’s new CEO is Andrew Witty, who had led the Optum unit.
 

Attractions of larger groups

Older doctors – those 55 years and up – were significantly more likely to work in small practices than those younger than 40, the 2020 survey found. Results showed 40.9% of doctors under 40 worked in practices of 10 or fewer colleagues, compared with 61.4% of those age 55 and older.

The large difference between age groups suggests that attrition is one reason for the shift in practice size. Retiring doctors who leave small practices are not being replaced on a one-for-one basis by younger doctors, AMA said. The same reason also appears to be a factor in the shift in practice ownership to larger systems.

Doctors in larger group practices can count on a stable business model, with a better ability to survive disruptive market trends, including those of a more extreme nature, like COVID-19, said Fred Horton, president of AMGA Consulting.

AMGA Consulting is a wholly-owned subsidiary of AMGA, formerly called American Medical Group Association. Its more than 400 members include well-known multispecialty groups and health care systems such as the Mayo Clinic, Cleveland Clinic, Geisinger, the Permanente Medical Group, and Intermountain Healthcare as well as many smaller physician practices.

Mr. Horton, who holds a master’s degree in health administration, said some doctors may want to participate in alternative payment programs offered by insurers, who are seeking to shift away from the fee-for-service model

“Larger organizations can dedicate more resources to continuous quality improvement,” Mr. Horton said. “This is especially important for physicians who are taking on risk-based contracts, as quality can directly impact how much they earn.”

For one oncologist, it was turning to alternative payment methods that helped him keep his private practice afloat.

Kashyap Patel, MD, chief executive of the Carolina Blood and Cancer Care Associates in Rock Hill, S.C., said he maintained the independence of his practice amid pressure from a large health system, which had been buying medical groups in the area. That began to interfere with referrals of patients from other doctors, which are key for cancer specialists, said Dr. Patel, who also is president of the Community Oncology Alliance.

In response, Dr. Patel worked with Blue Cross Blue Shield of South Carolina on an arrangement where his practice sought certifications from the National Committee for Quality Assurance to get better rates.

The effort has allowed Dr. Patel’s clinic to focus more on preventing hospitalizations and visits to the emergency room he said.

In Dr. Patel’s view, his patients benefit from his efforts to remain in independent practice. A switch to ownership by a large health care organization would have put them at risk for higher medical bills, jeopardizing their access to treatment, he said. The reason? Hospitals can charge more for services provided by doctors they employ.

“Nothing would change. I would be the same. The building would be the same, but the cost would go up,” Dr. Patel said.

For its part, the AHA has repeatedly challenged arguments that acquisitions and mergers result in higher costs for patients.

Instead, the AHA has raised alarms about consolidation of health insurers, a concern it shares with AMA. In a 2020 report examining competition among insurers, AMA noted doctors working in small practices can be put at a disadvantage if mergers and acquisitions leave an insurer with too much market power.

“Under antitrust law, independent physicians cannot negotiate collectively with health

Insurers,” the AMA said in the report. “This imbalance in relative size leaves most physicians with a weak bargaining position relative to commercial payers.”

AMA’s research on the effects of insurers’ wielding significant market clout has been used in effort to thwart mergers in this industry.
 

‘Dramatic restructuring’

The Federal Trade Commission also has taken note of the trends discussed in the new AMA report, saying that “U.S. physician markets are undergoing a dramatic restructuring.”

The FTC in January announced a study of the impact of the consolidation of doctors groups and health care facilities. FTC is seeking data for inpatient, outpatient, and doctors services in 15 states from 2015 through 2020. To gather this data, the commission has issued orders to six major insurers – Aetna, Anthem, Florida Blue, Cigna, Health Care Service Corporation and United Healthcare.

The FTC is concerned that acquired practices may have to alter their referral patterns to favor their affiliated hospital system over competing hospital systems. But FTC staff also said it might be that these acquisitions result in efficiencies, such as enhanced coordination of care between doctors and hospitals “that outweigh potential competitive harms.”

The research project will likely take several years to complete because of its scope, the FTC said. For that reason, the FTC said its Bureau of Economics will release a series of research papers examining different aspects of this inquiry rather than a single paper containing all of the analyses.
 

Private equity ‘roll-ups’

On the day the FTC announced the study of the impact of doctors groups, one of the panel’s commissioners argued for a closer look at how private equity firms make their purchases.

In a Jan. 15 tweet, FTC Commissioner Rohit Chopra said his agency needs to challenge their “roll-ups of small physician practices” as well as clinics and labs. This is a practice of using a series of acquisitions too small to trigger the federal threshold for a serious look from the FTC and Department of Justice. (The threshold for 2021 stands around the $92 million mark. This benchmark is known as Hart-Scott-Rodino notification after a 1976 law that set a reporting standard.)

Mr. Chopra attached to his Jan. 15 tweet a 2020 statement in which he called for stepped-up scrutiny of private-equity firms’ acquisitions of doctors’ practices. Mr. Chopra noted that private-equity firms have been buying practices focused on anesthesiology and emergency medicine, fields which triggered consumer complaints about surprise billing for emergency care.

“Given trends in today’s markets, it is critical that the FTC find new ways to ensure the agency has a rigorous, data-driven approach to market monitoring and enforcement,” Mr. Chopra wrote.

A version of this article first appeared on WebMD.com.

A group of bipartisan lawmakers intends to compel insurers to streamline prior authorization processes for Medicare Advantage plans, including a bid to end the use of faxes and develop systems that can allow for real-time decisions.

Rep. Suzan DelBene (D-Wash.); Rep. Mike Kelly (R-Pa.); Rep. Ami Bera, MD (D-Calif.); and Rep. Larry Bucshon, MD, (R-Ind.) on May 13 introduced a bill that would task federal officials with refining standards regarding prior authorization for Medicare Advantage. Titled the Improving Seniors’ Timely Access to Care Act of 2021, the bill would direct the Department of Health & Human Services to create rules intended to make prior authorization more transparent and speedy for the insurer-run Medicare plans. Known as Medicare Advantage, these plans cover about 24.1 million people of the 62 million enrolled in the giant federal health program, according to the nonprofit Kaiser Family Foundation.

These revamped prior authorization systems could not rely on faxes nor could they employ proprietary payer portals that did not meet HHS’ standards, says the text of the bill released by Rep. DelBene. Insurers would also have to report to the Centers for Medicare & Medicaid Services about the extent of their use of prior authorization and the rate of approvals or denials. The bill seeks to encourage plans to adopt prior authorization programs that adhere to evidence-based medical guidelines in consultation with physicians.

There were several reasons for focusing on Medicare Advantage plans, although prior authorization concerns extend more broadly in the U.S. health care system, said Susan Bailey, MD, president of the American Medical Association.

There’s an ample body of research about issues seen in the Medicare Advantage plans. Dr. Bailey also said that, in her experience, Medicare Advantage plans have had some of the most restrictive policies. And, by starting with Medicare Advantage, there’s a potential for a ripple effect in the industry, easing this issue when physicians work with other insurers as well.

“When Medicare adopts a policy whether it be a payment policy or a coverage policy, private insurers typically follow along,” she said.
 

Strong support among health care groups

There’s strong support for streamlining prior authorization both in the medical community and in Congress.

The bill has the support of about 70 health care organizations, including the AMA and the American Academy of Family Physicians, according to its sponsors. As of May 17, the bill had attracted the backing of 97 members of the House of Representatives, roughly evenly split among Democrats and Republicans.

Rep. DelBene’s previous version of this bill, the Improving Seniors’ Timely Access to Care Act of 2019, attracted 143 Democratic cosponsors and 137 Republican ones, or more than half of the members of the House. This bill was not completed during the previous session of Congress (January 2019–January 2021) because of the more urgent needs of pandemic response, said Rep. Bucshon, who practiced cardiothoracic surgery before joining Congress.

“It wasn’t quite on the radar as much as it might have been if we didn’t have COVID,” Rep. Bucshon said.

Rep. Bucshon added that he expects strong Senate support for a companion measure of the House bill, which could make the difference for efforts to pass it this year.

Insurers have become more aggressive over time in denying payments through prior authorization systems for services that physicians say their patients need, according to Rep. Bucshon. There may be some “bad actors” in medicine who would order unnecessary procedures, Rep. Bucshon allowed, but in most cases, the cumbersome prior authorization processes only put a hurdle for patients seeking needed treatments, he said.

“The premise is that it controls health care costs but actually what it does is it helps insurance company’s bottom line,” Rep. Bucshon said.

In a prepared statement, former Pennsylvania representative Allyson Y. Schwartz, now CEO of the Better Medicare Alliance, said her group had spoken with sponsors of this legislation and appreciates “their receptiveness to feedback in this process.”

“Prior authorization ensures beneficiaries receive clinically appropriate care and reduces exposures to duplicative and unnecessary services,” Ms. Schwartz said. “We share an interest in ensuring prior authorization works as smoothly and effectively as possible for beneficiaries while protecting its essential function of facilitating safe, evidenced-based care.”

The Better Medicare Alliance said its funders include UnitedHealth, Humana, and CVS Health/Aetna, which run Advantage plans. The group also lists as its partners many medical organizations.
 

“Rationing care by hassling”

Like Rep. Bucshon, Dr. Bailey sees a different motivation in insurers’ persistence in keeping the prior authorization process cumbersome.

Phone calls and faxes remain the key methods for handling prior authorization for medical services, according to the results of a survey done by the AMA in December. Phone calls were always or often required for prior authorization for medical services (59%), with faxes the second-most common approach (46%), followed by health plans’ online portals (39%), electronic health records and practice management systems (29%), and email or U.S. mail (26%), according to the AMA’s report on the survey.

“It seems like every step in the process is designed to make the patient less likely to get the therapy that the doctor thinks that the patient needs,” Dr. Bailey said. “It’s almost like rationing care by hassling the patient and the physician.”

The findings of an investigation by HHS’ internal watchdog unit appear to support Dr. Bailey’s view, showing that insurer-run Medicare plans had a pattern of often walking back their initial rejections.

In 2018, the Office of the Inspector General for HHS reported that Medicare Advantage organizations (MAOs) overturned 75% of their own denials during 2014-16. In addition, independent reviewers within the appeals process overturned additional denials in favor of patients and clinicians, OIG said.

“The high number of overturned denials raises concerns that some Medicare Advantage beneficiaries and providers were initially denied services and payments that should have been provided,” the OIG said in the report. “This is especially concerning because beneficiaries and providers rarely used the appeals process, which is designed to ensure access to care and payment.”

During 2014-2016, patients and clinicians appealed only 1% of denials to the first level of appeal, OIG said. In the report, the watchdog group noted that CMS audits had highlighted “widespread and persistent MAO performance problems related to denials of care and payment.” In 2015, for example, CMS cited 56% of audited contracts for making inappropriate denials.

Dr. Bailey also said in an interview that she routinely encounters problems with prior authorization in her own practice as an allergist and immunologist in Fort Worth, Tex.

In late May, for example, a Medicare Advantage plan made a patient whose chronic asthma had been stable for years change to a new inhaler that resulted in him developing a yeast infection in his mouth, Dr. Bailey said.

“We treated the yeast infection, made some changes in the way he uses his inhaler, so hopefully he would tolerate it better,” Dr. Bailey said. “He had a reaction to the medication to treat the yeast infection and ended up in the hospital. How is that helping anyone? It certainly hasn’t helped my patient.”

Dr. Bailey said insurers have also asked to seek prior authorization to prescribe medications that have been generic for years and have used the process to challenge her on cases of what seem to be common sense in medical practice. This included a bid to have Dr. Bailey prescribe a medication in pill form for a 6-month-old baby who had no teeth.

“Every doctor has got absurd stories like that, but unfortunately, every doctor is going to have tragic stories where prior authorization has resulted in death and harm to the patients,” Dr. Bailey said.

Some physicians leave it to the patient to try to overcome insurers’ decisions on prior authorization, seeing this task as falling outside of their duties, Dr. Bailey said.

“I don’t do that. I fight. I spend a lot of time fighting. I don’t like to lose. I don’t like my patients to lose, so I will go to the mat for them,” Dr. Bailey said. “But I’m blessed to be in a specialty where I’ve got loads more control over my schedule than many other specialties do.”

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

A group of bipartisan lawmakers intends to compel insurers to streamline prior authorization processes for Medicare Advantage plans, including a bid to end the use of faxes and develop systems that can allow for real-time decisions.

Rep. Suzan DelBene (D-Wash.); Rep. Mike Kelly (R-Pa.); Rep. Ami Bera, MD (D-Calif.); and Rep. Larry Bucshon, MD, (R-Ind.) on May 13 introduced a bill that would task federal officials with refining standards regarding prior authorization for Medicare Advantage. Titled the Improving Seniors’ Timely Access to Care Act of 2021, the bill would direct the Department of Health & Human Services to create rules intended to make prior authorization more transparent and speedy for the insurer-run Medicare plans. Known as Medicare Advantage, these plans cover about 24.1 million people of the 62 million enrolled in the giant federal health program, according to the nonprofit Kaiser Family Foundation.

These revamped prior authorization systems could not rely on faxes nor could they employ proprietary payer portals that did not meet HHS’ standards, says the text of the bill released by Rep. DelBene. Insurers would also have to report to the Centers for Medicare & Medicaid Services about the extent of their use of prior authorization and the rate of approvals or denials. The bill seeks to encourage plans to adopt prior authorization programs that adhere to evidence-based medical guidelines in consultation with physicians.

There were several reasons for focusing on Medicare Advantage plans, although prior authorization concerns extend more broadly in the U.S. health care system, said Susan Bailey, MD, president of the American Medical Association.

There’s an ample body of research about issues seen in the Medicare Advantage plans. Dr. Bailey also said that, in her experience, Medicare Advantage plans have had some of the most restrictive policies. And, by starting with Medicare Advantage, there’s a potential for a ripple effect in the industry, easing this issue when physicians work with other insurers as well.

“When Medicare adopts a policy whether it be a payment policy or a coverage policy, private insurers typically follow along,” she said.
 

Strong support among health care groups

There’s strong support for streamlining prior authorization both in the medical community and in Congress.

The bill has the support of about 70 health care organizations, including the AMA and the American Academy of Family Physicians, according to its sponsors. As of May 17, the bill had attracted the backing of 97 members of the House of Representatives, roughly evenly split among Democrats and Republicans.

Rep. DelBene’s previous version of this bill, the Improving Seniors’ Timely Access to Care Act of 2019, attracted 143 Democratic cosponsors and 137 Republican ones, or more than half of the members of the House. This bill was not completed during the previous session of Congress (January 2019–January 2021) because of the more urgent needs of pandemic response, said Rep. Bucshon, who practiced cardiothoracic surgery before joining Congress.

“It wasn’t quite on the radar as much as it might have been if we didn’t have COVID,” Rep. Bucshon said.

Rep. Bucshon added that he expects strong Senate support for a companion measure of the House bill, which could make the difference for efforts to pass it this year.

Insurers have become more aggressive over time in denying payments through prior authorization systems for services that physicians say their patients need, according to Rep. Bucshon. There may be some “bad actors” in medicine who would order unnecessary procedures, Rep. Bucshon allowed, but in most cases, the cumbersome prior authorization processes only put a hurdle for patients seeking needed treatments, he said.

“The premise is that it controls health care costs but actually what it does is it helps insurance company’s bottom line,” Rep. Bucshon said.

In a prepared statement, former Pennsylvania representative Allyson Y. Schwartz, now CEO of the Better Medicare Alliance, said her group had spoken with sponsors of this legislation and appreciates “their receptiveness to feedback in this process.”

“Prior authorization ensures beneficiaries receive clinically appropriate care and reduces exposures to duplicative and unnecessary services,” Ms. Schwartz said. “We share an interest in ensuring prior authorization works as smoothly and effectively as possible for beneficiaries while protecting its essential function of facilitating safe, evidenced-based care.”

The Better Medicare Alliance said its funders include UnitedHealth, Humana, and CVS Health/Aetna, which run Advantage plans. The group also lists as its partners many medical organizations.
 

“Rationing care by hassling”

Like Rep. Bucshon, Dr. Bailey sees a different motivation in insurers’ persistence in keeping the prior authorization process cumbersome.

Phone calls and faxes remain the key methods for handling prior authorization for medical services, according to the results of a survey done by the AMA in December. Phone calls were always or often required for prior authorization for medical services (59%), with faxes the second-most common approach (46%), followed by health plans’ online portals (39%), electronic health records and practice management systems (29%), and email or U.S. mail (26%), according to the AMA’s report on the survey.

“It seems like every step in the process is designed to make the patient less likely to get the therapy that the doctor thinks that the patient needs,” Dr. Bailey said. “It’s almost like rationing care by hassling the patient and the physician.”

The findings of an investigation by HHS’ internal watchdog unit appear to support Dr. Bailey’s view, showing that insurer-run Medicare plans had a pattern of often walking back their initial rejections.

In 2018, the Office of the Inspector General for HHS reported that Medicare Advantage organizations (MAOs) overturned 75% of their own denials during 2014-16. In addition, independent reviewers within the appeals process overturned additional denials in favor of patients and clinicians, OIG said.

“The high number of overturned denials raises concerns that some Medicare Advantage beneficiaries and providers were initially denied services and payments that should have been provided,” the OIG said in the report. “This is especially concerning because beneficiaries and providers rarely used the appeals process, which is designed to ensure access to care and payment.”

During 2014-2016, patients and clinicians appealed only 1% of denials to the first level of appeal, OIG said. In the report, the watchdog group noted that CMS audits had highlighted “widespread and persistent MAO performance problems related to denials of care and payment.” In 2015, for example, CMS cited 56% of audited contracts for making inappropriate denials.

Dr. Bailey also said in an interview that she routinely encounters problems with prior authorization in her own practice as an allergist and immunologist in Fort Worth, Tex.

In late May, for example, a Medicare Advantage plan made a patient whose chronic asthma had been stable for years change to a new inhaler that resulted in him developing a yeast infection in his mouth, Dr. Bailey said.

“We treated the yeast infection, made some changes in the way he uses his inhaler, so hopefully he would tolerate it better,” Dr. Bailey said. “He had a reaction to the medication to treat the yeast infection and ended up in the hospital. How is that helping anyone? It certainly hasn’t helped my patient.”

Dr. Bailey said insurers have also asked to seek prior authorization to prescribe medications that have been generic for years and have used the process to challenge her on cases of what seem to be common sense in medical practice. This included a bid to have Dr. Bailey prescribe a medication in pill form for a 6-month-old baby who had no teeth.

“Every doctor has got absurd stories like that, but unfortunately, every doctor is going to have tragic stories where prior authorization has resulted in death and harm to the patients,” Dr. Bailey said.

Some physicians leave it to the patient to try to overcome insurers’ decisions on prior authorization, seeing this task as falling outside of their duties, Dr. Bailey said.

“I don’t do that. I fight. I spend a lot of time fighting. I don’t like to lose. I don’t like my patients to lose, so I will go to the mat for them,” Dr. Bailey said. “But I’m blessed to be in a specialty where I’ve got loads more control over my schedule than many other specialties do.”

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

A group of bipartisan lawmakers intends to compel insurers to streamline prior authorization processes for Medicare Advantage plans, including a bid to end the use of faxes and develop systems that can allow for real-time decisions.

Rep. Suzan DelBene (D-Wash.); Rep. Mike Kelly (R-Pa.); Rep. Ami Bera, MD (D-Calif.); and Rep. Larry Bucshon, MD, (R-Ind.) on May 13 introduced a bill that would task federal officials with refining standards regarding prior authorization for Medicare Advantage. Titled the Improving Seniors’ Timely Access to Care Act of 2021, the bill would direct the Department of Health & Human Services to create rules intended to make prior authorization more transparent and speedy for the insurer-run Medicare plans. Known as Medicare Advantage, these plans cover about 24.1 million people of the 62 million enrolled in the giant federal health program, according to the nonprofit Kaiser Family Foundation.

These revamped prior authorization systems could not rely on faxes nor could they employ proprietary payer portals that did not meet HHS’ standards, says the text of the bill released by Rep. DelBene. Insurers would also have to report to the Centers for Medicare & Medicaid Services about the extent of their use of prior authorization and the rate of approvals or denials. The bill seeks to encourage plans to adopt prior authorization programs that adhere to evidence-based medical guidelines in consultation with physicians.

There were several reasons for focusing on Medicare Advantage plans, although prior authorization concerns extend more broadly in the U.S. health care system, said Susan Bailey, MD, president of the American Medical Association.

There’s an ample body of research about issues seen in the Medicare Advantage plans. Dr. Bailey also said that, in her experience, Medicare Advantage plans have had some of the most restrictive policies. And, by starting with Medicare Advantage, there’s a potential for a ripple effect in the industry, easing this issue when physicians work with other insurers as well.

“When Medicare adopts a policy whether it be a payment policy or a coverage policy, private insurers typically follow along,” she said.
 

Strong support among health care groups

There’s strong support for streamlining prior authorization both in the medical community and in Congress.

The bill has the support of about 70 health care organizations, including the AMA and the American Academy of Family Physicians, according to its sponsors. As of May 17, the bill had attracted the backing of 97 members of the House of Representatives, roughly evenly split among Democrats and Republicans.

Rep. DelBene’s previous version of this bill, the Improving Seniors’ Timely Access to Care Act of 2019, attracted 143 Democratic cosponsors and 137 Republican ones, or more than half of the members of the House. This bill was not completed during the previous session of Congress (January 2019–January 2021) because of the more urgent needs of pandemic response, said Rep. Bucshon, who practiced cardiothoracic surgery before joining Congress.

“It wasn’t quite on the radar as much as it might have been if we didn’t have COVID,” Rep. Bucshon said.

Rep. Bucshon added that he expects strong Senate support for a companion measure of the House bill, which could make the difference for efforts to pass it this year.

Insurers have become more aggressive over time in denying payments through prior authorization systems for services that physicians say their patients need, according to Rep. Bucshon. There may be some “bad actors” in medicine who would order unnecessary procedures, Rep. Bucshon allowed, but in most cases, the cumbersome prior authorization processes only put a hurdle for patients seeking needed treatments, he said.

“The premise is that it controls health care costs but actually what it does is it helps insurance company’s bottom line,” Rep. Bucshon said.

In a prepared statement, former Pennsylvania representative Allyson Y. Schwartz, now CEO of the Better Medicare Alliance, said her group had spoken with sponsors of this legislation and appreciates “their receptiveness to feedback in this process.”

“Prior authorization ensures beneficiaries receive clinically appropriate care and reduces exposures to duplicative and unnecessary services,” Ms. Schwartz said. “We share an interest in ensuring prior authorization works as smoothly and effectively as possible for beneficiaries while protecting its essential function of facilitating safe, evidenced-based care.”

The Better Medicare Alliance said its funders include UnitedHealth, Humana, and CVS Health/Aetna, which run Advantage plans. The group also lists as its partners many medical organizations.
 

“Rationing care by hassling”

Like Rep. Bucshon, Dr. Bailey sees a different motivation in insurers’ persistence in keeping the prior authorization process cumbersome.

Phone calls and faxes remain the key methods for handling prior authorization for medical services, according to the results of a survey done by the AMA in December. Phone calls were always or often required for prior authorization for medical services (59%), with faxes the second-most common approach (46%), followed by health plans’ online portals (39%), electronic health records and practice management systems (29%), and email or U.S. mail (26%), according to the AMA’s report on the survey.

“It seems like every step in the process is designed to make the patient less likely to get the therapy that the doctor thinks that the patient needs,” Dr. Bailey said. “It’s almost like rationing care by hassling the patient and the physician.”

The findings of an investigation by HHS’ internal watchdog unit appear to support Dr. Bailey’s view, showing that insurer-run Medicare plans had a pattern of often walking back their initial rejections.

In 2018, the Office of the Inspector General for HHS reported that Medicare Advantage organizations (MAOs) overturned 75% of their own denials during 2014-16. In addition, independent reviewers within the appeals process overturned additional denials in favor of patients and clinicians, OIG said.

“The high number of overturned denials raises concerns that some Medicare Advantage beneficiaries and providers were initially denied services and payments that should have been provided,” the OIG said in the report. “This is especially concerning because beneficiaries and providers rarely used the appeals process, which is designed to ensure access to care and payment.”

During 2014-2016, patients and clinicians appealed only 1% of denials to the first level of appeal, OIG said. In the report, the watchdog group noted that CMS audits had highlighted “widespread and persistent MAO performance problems related to denials of care and payment.” In 2015, for example, CMS cited 56% of audited contracts for making inappropriate denials.

Dr. Bailey also said in an interview that she routinely encounters problems with prior authorization in her own practice as an allergist and immunologist in Fort Worth, Tex.

In late May, for example, a Medicare Advantage plan made a patient whose chronic asthma had been stable for years change to a new inhaler that resulted in him developing a yeast infection in his mouth, Dr. Bailey said.

“We treated the yeast infection, made some changes in the way he uses his inhaler, so hopefully he would tolerate it better,” Dr. Bailey said. “He had a reaction to the medication to treat the yeast infection and ended up in the hospital. How is that helping anyone? It certainly hasn’t helped my patient.”

Dr. Bailey said insurers have also asked to seek prior authorization to prescribe medications that have been generic for years and have used the process to challenge her on cases of what seem to be common sense in medical practice. This included a bid to have Dr. Bailey prescribe a medication in pill form for a 6-month-old baby who had no teeth.

“Every doctor has got absurd stories like that, but unfortunately, every doctor is going to have tragic stories where prior authorization has resulted in death and harm to the patients,” Dr. Bailey said.

Some physicians leave it to the patient to try to overcome insurers’ decisions on prior authorization, seeing this task as falling outside of their duties, Dr. Bailey said.

“I don’t do that. I fight. I spend a lot of time fighting. I don’t like to lose. I don’t like my patients to lose, so I will go to the mat for them,” Dr. Bailey said. “But I’m blessed to be in a specialty where I’ve got loads more control over my schedule than many other specialties do.”

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