A new study offers fresh insight into early indications of high-risk, early-stage, epithelial ovarian cancer: More than 70% have at least one symptom such as abdominal/pelvic pain or increased girth/fullness, and women with larger tumors have more symptoms.

“Even in early-stage disease, ovarian cancer is not necessarily a silent disease,” said lead author and gynecologic oncologist/surgeon John K. Chan, MD, of Palo Alto Medical Foundation/California Pacific/Sutter Research Institute.

The study appeared online Jan. 6, in the journal Obstetrics & Gynecology.*

According to Dr. Chan, most previous studies of symptoms in ovarian cancer have focused on those with advanced disease since that’s when it’s typically diagnosed. “Given these gaps in knowledge from prior reports, we performed this analysis to evaluate the presentation and characteristic symptoms of early-stage ovarian cancer and to attempt to identify the relationship between these symptoms with respect to clinicopathologic characteristics and prognosis in early-stage disease.”

Dr. Chan and colleagues retrospectively tracked 419 patients who were subjects in a clinical trial of chemotherapy doses. The patients all had high-risk, early-stage epithelial ovarian cancer (stage IA-IB and grade 3, any clear cell, stage IC or II).

Of the patients, 40% presented with one symptom, while 32% had multiple symptoms. The other 28% had no symptoms, and their masses were diagnosed upon discovery during physical examination. “Other investigators have found that nearly 95% of patients with ovarian cancer were symptomatic,” Dr. Chan said. “The lower percentage of symptomatic patients in our study may be because all 419 patients had early-stage disease as opposed to advanced-stage disease.”

The most common symptoms were abdominal or pelvic pain (31%; 95% confidence interval, 27%-36%), fullness or increased abdominal girth (27%; 95% CI, 22%-31%), abnormal vaginal bleeding (13%; 95% CI, 10%-17%), urinary problems (10%; 95% CI, 8%-14%), and gastrointestinal problems (6%; 95% CI, 4%-8%).

There was no statistically significant link between number of symptoms and age (younger than 60 or 60 or older), cancer stage, or histologic subtype. However, patients with the largest tumors (>15 cm) were more likely to have multiple symptoms than those with the smallest tumors (10 cm or smaller): 46% vs. 21% (P < .001).

Also, 79% of those with the largest tumors (>15 cm) had at least one symptom, compared with 65% of those with the smallest tumors (10 cm or smaller, P < .001)

Unlike other studies, this report didn’t find a link between the number of symptoms and mortality. This finding surprised the researchers, Dr. Chan said, as did the lack of connections between symptoms and age, stage, or histologic subtype. “We were expecting that the younger patients may have more symptoms given the association with endometriosis and clear cell cancers,” he said. “We also thought that those who are less symptomatic may have more stage I and low-grade indolent tumors with better survival, but we did not find that.”

The researchers noted limitations such as the lack of standardization in the patient data.

In the big picture, Dr. Chan said, “patients and health care professionals need to have a higher index of suspicion in symptomatic ovarian cancer patients to increase early detection and potentially improve cures. Ovarian cancer does not always kill. In fact, up to 80% of our early-stage disease patients are cured.”

He called for “additional research to evaluate symptom awareness in early-stage cancers and possibly incorporating novel serum biomarkers and wearable monitoring devices. Wearables may be able to assess for frequency or duration of symptoms, which may be an important factor in distinguishing symptoms that are more concerning for ovarian cancer.”

In an adjoining commentary, Barbara A. Goff, MD, chair of obstetrics and gynecology at the University of Washington, Seattle, noted that, while ovarian cancers diagnosed early have a high survival rate, prospective randomized trials of transvaginal ultrasonography and tumor marker screening strategies have failed to reduce mortality. There’s currently no recommended screening test for women at average risk.

There are other challenges, she wrote. For one, “many health care professionals are seemingly unaware of the symptoms typically associated with ovarian cancer, so misdiagnosis remains common.” And “one of the concerns about the symptoms of ovarian cancer is that they can be vague and commonly present in the general population.”

Dr. Goff praised the study, called for more education about the symptoms of ovarian cancer, and wrote that “symptom recognition with appropriate diagnostic testing remains very important in our efforts to improve outcomes.”

The National Institutes of Health funded the study. Several study authors, including Dr. Chan, reported various disclosures.

Correction, 1/31/22: An earlier version of this article misstated the date of publication.

A new study offers fresh insight into early indications of high-risk, early-stage, epithelial ovarian cancer: More than 70% have at least one symptom such as abdominal/pelvic pain or increased girth/fullness, and women with larger tumors have more symptoms.

“Even in early-stage disease, ovarian cancer is not necessarily a silent disease,” said lead author and gynecologic oncologist/surgeon John K. Chan, MD, of Palo Alto Medical Foundation/California Pacific/Sutter Research Institute.

The study appeared online Jan. 6, in the journal Obstetrics & Gynecology.*

According to Dr. Chan, most previous studies of symptoms in ovarian cancer have focused on those with advanced disease since that’s when it’s typically diagnosed. “Given these gaps in knowledge from prior reports, we performed this analysis to evaluate the presentation and characteristic symptoms of early-stage ovarian cancer and to attempt to identify the relationship between these symptoms with respect to clinicopathologic characteristics and prognosis in early-stage disease.”

Dr. Chan and colleagues retrospectively tracked 419 patients who were subjects in a clinical trial of chemotherapy doses. The patients all had high-risk, early-stage epithelial ovarian cancer (stage IA-IB and grade 3, any clear cell, stage IC or II).

Of the patients, 40% presented with one symptom, while 32% had multiple symptoms. The other 28% had no symptoms, and their masses were diagnosed upon discovery during physical examination. “Other investigators have found that nearly 95% of patients with ovarian cancer were symptomatic,” Dr. Chan said. “The lower percentage of symptomatic patients in our study may be because all 419 patients had early-stage disease as opposed to advanced-stage disease.”

The most common symptoms were abdominal or pelvic pain (31%; 95% confidence interval, 27%-36%), fullness or increased abdominal girth (27%; 95% CI, 22%-31%), abnormal vaginal bleeding (13%; 95% CI, 10%-17%), urinary problems (10%; 95% CI, 8%-14%), and gastrointestinal problems (6%; 95% CI, 4%-8%).

There was no statistically significant link between number of symptoms and age (younger than 60 or 60 or older), cancer stage, or histologic subtype. However, patients with the largest tumors (>15 cm) were more likely to have multiple symptoms than those with the smallest tumors (10 cm or smaller): 46% vs. 21% (P < .001).

Also, 79% of those with the largest tumors (>15 cm) had at least one symptom, compared with 65% of those with the smallest tumors (10 cm or smaller, P < .001)

Unlike other studies, this report didn’t find a link between the number of symptoms and mortality. This finding surprised the researchers, Dr. Chan said, as did the lack of connections between symptoms and age, stage, or histologic subtype. “We were expecting that the younger patients may have more symptoms given the association with endometriosis and clear cell cancers,” he said. “We also thought that those who are less symptomatic may have more stage I and low-grade indolent tumors with better survival, but we did not find that.”

The researchers noted limitations such as the lack of standardization in the patient data.

In the big picture, Dr. Chan said, “patients and health care professionals need to have a higher index of suspicion in symptomatic ovarian cancer patients to increase early detection and potentially improve cures. Ovarian cancer does not always kill. In fact, up to 80% of our early-stage disease patients are cured.”

He called for “additional research to evaluate symptom awareness in early-stage cancers and possibly incorporating novel serum biomarkers and wearable monitoring devices. Wearables may be able to assess for frequency or duration of symptoms, which may be an important factor in distinguishing symptoms that are more concerning for ovarian cancer.”

In an adjoining commentary, Barbara A. Goff, MD, chair of obstetrics and gynecology at the University of Washington, Seattle, noted that, while ovarian cancers diagnosed early have a high survival rate, prospective randomized trials of transvaginal ultrasonography and tumor marker screening strategies have failed to reduce mortality. There’s currently no recommended screening test for women at average risk.

There are other challenges, she wrote. For one, “many health care professionals are seemingly unaware of the symptoms typically associated with ovarian cancer, so misdiagnosis remains common.” And “one of the concerns about the symptoms of ovarian cancer is that they can be vague and commonly present in the general population.”

Dr. Goff praised the study, called for more education about the symptoms of ovarian cancer, and wrote that “symptom recognition with appropriate diagnostic testing remains very important in our efforts to improve outcomes.”

The National Institutes of Health funded the study. Several study authors, including Dr. Chan, reported various disclosures.

Correction, 1/31/22: An earlier version of this article misstated the date of publication.

A new study offers fresh insight into early indications of high-risk, early-stage, epithelial ovarian cancer: More than 70% have at least one symptom such as abdominal/pelvic pain or increased girth/fullness, and women with larger tumors have more symptoms.

“Even in early-stage disease, ovarian cancer is not necessarily a silent disease,” said lead author and gynecologic oncologist/surgeon John K. Chan, MD, of Palo Alto Medical Foundation/California Pacific/Sutter Research Institute.

The study appeared online Jan. 6, in the journal Obstetrics & Gynecology.*

According to Dr. Chan, most previous studies of symptoms in ovarian cancer have focused on those with advanced disease since that’s when it’s typically diagnosed. “Given these gaps in knowledge from prior reports, we performed this analysis to evaluate the presentation and characteristic symptoms of early-stage ovarian cancer and to attempt to identify the relationship between these symptoms with respect to clinicopathologic characteristics and prognosis in early-stage disease.”

Dr. Chan and colleagues retrospectively tracked 419 patients who were subjects in a clinical trial of chemotherapy doses. The patients all had high-risk, early-stage epithelial ovarian cancer (stage IA-IB and grade 3, any clear cell, stage IC or II).

Of the patients, 40% presented with one symptom, while 32% had multiple symptoms. The other 28% had no symptoms, and their masses were diagnosed upon discovery during physical examination. “Other investigators have found that nearly 95% of patients with ovarian cancer were symptomatic,” Dr. Chan said. “The lower percentage of symptomatic patients in our study may be because all 419 patients had early-stage disease as opposed to advanced-stage disease.”

The most common symptoms were abdominal or pelvic pain (31%; 95% confidence interval, 27%-36%), fullness or increased abdominal girth (27%; 95% CI, 22%-31%), abnormal vaginal bleeding (13%; 95% CI, 10%-17%), urinary problems (10%; 95% CI, 8%-14%), and gastrointestinal problems (6%; 95% CI, 4%-8%).

There was no statistically significant link between number of symptoms and age (younger than 60 or 60 or older), cancer stage, or histologic subtype. However, patients with the largest tumors (>15 cm) were more likely to have multiple symptoms than those with the smallest tumors (10 cm or smaller): 46% vs. 21% (P < .001).

Also, 79% of those with the largest tumors (>15 cm) had at least one symptom, compared with 65% of those with the smallest tumors (10 cm or smaller, P < .001)

Unlike other studies, this report didn’t find a link between the number of symptoms and mortality. This finding surprised the researchers, Dr. Chan said, as did the lack of connections between symptoms and age, stage, or histologic subtype. “We were expecting that the younger patients may have more symptoms given the association with endometriosis and clear cell cancers,” he said. “We also thought that those who are less symptomatic may have more stage I and low-grade indolent tumors with better survival, but we did not find that.”

The researchers noted limitations such as the lack of standardization in the patient data.

In the big picture, Dr. Chan said, “patients and health care professionals need to have a higher index of suspicion in symptomatic ovarian cancer patients to increase early detection and potentially improve cures. Ovarian cancer does not always kill. In fact, up to 80% of our early-stage disease patients are cured.”

He called for “additional research to evaluate symptom awareness in early-stage cancers and possibly incorporating novel serum biomarkers and wearable monitoring devices. Wearables may be able to assess for frequency or duration of symptoms, which may be an important factor in distinguishing symptoms that are more concerning for ovarian cancer.”

In an adjoining commentary, Barbara A. Goff, MD, chair of obstetrics and gynecology at the University of Washington, Seattle, noted that, while ovarian cancers diagnosed early have a high survival rate, prospective randomized trials of transvaginal ultrasonography and tumor marker screening strategies have failed to reduce mortality. There’s currently no recommended screening test for women at average risk.

There are other challenges, she wrote. For one, “many health care professionals are seemingly unaware of the symptoms typically associated with ovarian cancer, so misdiagnosis remains common.” And “one of the concerns about the symptoms of ovarian cancer is that they can be vague and commonly present in the general population.”

Dr. Goff praised the study, called for more education about the symptoms of ovarian cancer, and wrote that “symptom recognition with appropriate diagnostic testing remains very important in our efforts to improve outcomes.”

The National Institutes of Health funded the study. Several study authors, including Dr. Chan, reported various disclosures.

Correction, 1/31/22: An earlier version of this article misstated the date of publication.

Before reading this editorial and concluding that the author (me) has lost his grip on reality, I would ask that you consider the facts I provide below and the ramifications incurred by your patients and practices, due to the misbehaviors adopted by the health insurance industry.

• Two of the most common issues discussed in today’s health care environment are revenue generation and provider/staff burnout.

While these issues are impacted by several factors, one of the most common denominators is increasing administrative workloads driven by non–revenue-generating activities. Consider this:

• A recent American Medical Association survey pointed out that during the course of the average workweek, a physician completes an average of 37 prior authorization requests. Physicians and their staff spend an average of 16.4 hours per week completing prior authorization requirements for patient medicines, procedures, and medical services that they may need.¹
• While physicians report that about 65% of prior authorizations take only 1 day, they report that 26% take 3 or more days.²

The potential significance of the generated delays

While this may not seem like a long time (other than the impact it has on staff workload), consider the impact this can have on the patient if the medication being requested is: PrEP, the morning after pill, or other contraceptives? The consequences of the delay or denial could be a lifetime living with HIV, or an unintended pregnancy. This is to say nothing on the larger impact to family, partners, and the potential social stigma faced by all.

Beyond the personal costs and costs within your practice associated with the additional workload, consider the financial costs. The average cost to complete a prior authorization remains the single highest cost for the health care industry at $13.40 per manual transaction, and $7.19 per partially electronic web portal transaction,³ meaning that if I did only one prescription per week, I probably would not mind, but at $13.40 per prior authorization, this burden amounts to millions, actually $767 million by recent estimates.³ Additionally, if you factor in the number of denials and potential follow-ups, this creates a significant amount of waste and spending.

Ultimately, in my experience, I have found that most prior authorizations are simply unnecessary. Here, I’ve picked key examples from just my own recent experiences:

1. My patient was denied access to a particular birth control pill she had been on successfully before, and my office was told she needed to try and fail on 5 different generic pills before she could be approved. However, the Affordable Care Act’s (ACA; aka Obamacare) Contraceptive Mandate requires coverage of all contraceptives determined to be most appropriate between a patient and their provider (see below).
2. A menopausal patient was denied coverage twice (electronically) for generic micronized progesterone, and I was asked to write a letter of appeal because the insurance company wanted me to use medroxyprogesterone acetate instead. Polling my nearby retail independent pharmacy, the total cost difference per year was $19.96 savings/year ($47.01 ‒ $27.05 = $19.96). My pharmacist did note it could have been a different amount at a large chain pharmacy. Really? I had to write a letter, following two denials, to save less than $20, for a full year!
3. A 78-year-old patient using Prolia for severe osteoporosis and preexisting fractures was delayed in getting her next Prolia injection due to a prior authorization snafu. She ended up with multiple additional fractures, a well-described effect of the increase in bone turnover when stopping or delaying this medication. She is now disabled.
4. A 94-year-old patient was sent an email reminder to get the medical practice to authorize a refill of ileostomy bags. The email went to spam, and the patient ran out of bags prior to a holiday weekend. I got them in 2 days on Amazon Prime. But who emails a 94-year-old? And ileostomy bags! When does anyone stop needing ileostomy bags?
5. I requested a prior authorization for Orilissa (clearly off label) because a severely progestogen-sensitive patient (augmented depression) with severe premenstrual dysphoric disorder requiring hospitalization was thought by her psychiatrist to be better off without menstrual periods. I completed the proper paperwork, two electronic appeals, and a letter of explanation including available references on the use of gonadotropin-releasing hormone analogues for such patients. I was then told I would need to have a peer-to-peer discussion, so I filled out that paperwork, which clearly noted that I am a board-certified reproductive endocrinologist. I got a phone call a few days later by a pleasant, young-sounding pediatric rheumatologist. Our interaction did not go well for him. This was not peer-to-peer!

Let us be clear, prior authorizations have nothing to do with patient care. In fact, they are solely about the money. We in ObGyn have mostly inexpensive and generic products, but even that fact has not lowered the excessive burden of the prior authorization process. In the case of contraception, whether you like the ACA or not it is the law, and it contains specific provisions regarding contraception. With the goals of providing broad access to patients and incentives to developers for new and novel contraceptive methods, these provisions require insurers to cover, without cost-sharing, women’s preventive services including the full range of FDA-approved contraceptives (currently 18 different method categories), and additional methods identified by the FDA as they become available. Further, providers must have an easily accessible, transparent, and sufficiently expedient exceptions process that is not unduly burdensome on the individual or a provider (or other individuals acting as a patient’s authorized representative).

And while I can regale you with chapter and verse and citations of the legal precedent and language, it boils down to this:

• The AMA reported that medical practices spend an average of 2 business days a week per physician to comply with health plans’ inefficient and overused prior-authorization protocols.⁴ To keep up with the administrative burden, 2 out of 5 physicians (40%) employ staff members who work exclusively on tasks associated with prior authorization.⁴
• About 86% of practices reported an increased burden of prior authorizations in the last 5 years.⁵

Continue to: What is to be done?

I do have suggested solutions. Given the insurance industry’s complete lack of progress in voluntarily reducing the burdens of prior authorizations agreed to in their consensus statement with the AMA, American Hospital Association, America’s Health Insurance Plans, American Pharmacists Association, Blue Cross Blue Shield Association, and the Medical Group Management Association, I say, why not fine them? The AMA is calling on Congress to pass legislation that would codify much of the agreement, in which the above parties had already agreed that reforms were needed to reduce prior authorization burdens and enhance patient-centered care.⁶

A good model for enforcement via fines could be based on the old “incident to” rules of Medicare. These state that a physician needs to be “in the space” when advanced practice nurses or physician assistants see Medicare recipients. If they are not actually “in the space” they are subject to a fine. As a completely theoretical example, let’s say the claim was for $100. The practitioner would have to pay it back plus triple that amount in damages, or $400. They can also be fined up to $11,000 per claim and kick you out of Medicare and Medicaid. Take my example of Prolia from above…a single shot of Prolia is about $1,000. The insurer would theoretically have to pay $14,000/claim (the claim + triple damages + $11,000) if it was determined that the prior authorization was unnecessary. Seems about right to me. Or we could just sit the health insurance CEOs and their proxies in the corner on 2-foot-tall plastic Little Tikes® chairs for a “timeout” (dunce cap optional), like the outset of the article says.

Until the detrimental prior authorization process is challenged at all levels, we will continue to see and feel the effects of the harm it causes. Being able to drive change through advocacy and education is the best way we as clinicians can impact not just the future of health care but provide for the daily care of our patients who depend on and trust us to provide for their medical needs. We must be the impactors of change for ourselves, colleagues, staff, and profession if we are to really make advancements into the future.

Oh…and health insurance CEOs and their proxies, to get out of their “time-out” would still be entitled to one phone call to beg forgiveness from their mommies/daddies, priest/ rabbi/pastor, psychologist/psychiatrist/mystic healer, etc., but alas, the average wait time is an hour, and if anyone answers the phone, they have a grade school education used in following an irrelevant algorithm. ●

Before reading this editorial and concluding that the author (me) has lost his grip on reality, I would ask that you consider the facts I provide below and the ramifications incurred by your patients and practices, due to the misbehaviors adopted by the health insurance industry.

• Two of the most common issues discussed in today’s health care environment are revenue generation and provider/staff burnout.

While these issues are impacted by several factors, one of the most common denominators is increasing administrative workloads driven by non–revenue-generating activities. Consider this:

• A recent American Medical Association survey pointed out that during the course of the average workweek, a physician completes an average of 37 prior authorization requests. Physicians and their staff spend an average of 16.4 hours per week completing prior authorization requirements for patient medicines, procedures, and medical services that they may need.¹
• While physicians report that about 65% of prior authorizations take only 1 day, they report that 26% take 3 or more days.²

The potential significance of the generated delays

While this may not seem like a long time (other than the impact it has on staff workload), consider the impact this can have on the patient if the medication being requested is: PrEP, the morning after pill, or other contraceptives? The consequences of the delay or denial could be a lifetime living with HIV, or an unintended pregnancy. This is to say nothing on the larger impact to family, partners, and the potential social stigma faced by all.

Beyond the personal costs and costs within your practice associated with the additional workload, consider the financial costs. The average cost to complete a prior authorization remains the single highest cost for the health care industry at $13.40 per manual transaction, and $7.19 per partially electronic web portal transaction,³ meaning that if I did only one prescription per week, I probably would not mind, but at $13.40 per prior authorization, this burden amounts to millions, actually $767 million by recent estimates.³ Additionally, if you factor in the number of denials and potential follow-ups, this creates a significant amount of waste and spending.

Ultimately, in my experience, I have found that most prior authorizations are simply unnecessary. Here, I’ve picked key examples from just my own recent experiences:

1. My patient was denied access to a particular birth control pill she had been on successfully before, and my office was told she needed to try and fail on 5 different generic pills before she could be approved. However, the Affordable Care Act’s (ACA; aka Obamacare) Contraceptive Mandate requires coverage of all contraceptives determined to be most appropriate between a patient and their provider (see below).
2. A menopausal patient was denied coverage twice (electronically) for generic micronized progesterone, and I was asked to write a letter of appeal because the insurance company wanted me to use medroxyprogesterone acetate instead. Polling my nearby retail independent pharmacy, the total cost difference per year was $19.96 savings/year ($47.01 ‒ $27.05 = $19.96). My pharmacist did note it could have been a different amount at a large chain pharmacy. Really? I had to write a letter, following two denials, to save less than $20, for a full year!
3. A 78-year-old patient using Prolia for severe osteoporosis and preexisting fractures was delayed in getting her next Prolia injection due to a prior authorization snafu. She ended up with multiple additional fractures, a well-described effect of the increase in bone turnover when stopping or delaying this medication. She is now disabled.
4. A 94-year-old patient was sent an email reminder to get the medical practice to authorize a refill of ileostomy bags. The email went to spam, and the patient ran out of bags prior to a holiday weekend. I got them in 2 days on Amazon Prime. But who emails a 94-year-old? And ileostomy bags! When does anyone stop needing ileostomy bags?
5. I requested a prior authorization for Orilissa (clearly off label) because a severely progestogen-sensitive patient (augmented depression) with severe premenstrual dysphoric disorder requiring hospitalization was thought by her psychiatrist to be better off without menstrual periods. I completed the proper paperwork, two electronic appeals, and a letter of explanation including available references on the use of gonadotropin-releasing hormone analogues for such patients. I was then told I would need to have a peer-to-peer discussion, so I filled out that paperwork, which clearly noted that I am a board-certified reproductive endocrinologist. I got a phone call a few days later by a pleasant, young-sounding pediatric rheumatologist. Our interaction did not go well for him. This was not peer-to-peer!

Let us be clear, prior authorizations have nothing to do with patient care. In fact, they are solely about the money. We in ObGyn have mostly inexpensive and generic products, but even that fact has not lowered the excessive burden of the prior authorization process. In the case of contraception, whether you like the ACA or not it is the law, and it contains specific provisions regarding contraception. With the goals of providing broad access to patients and incentives to developers for new and novel contraceptive methods, these provisions require insurers to cover, without cost-sharing, women’s preventive services including the full range of FDA-approved contraceptives (currently 18 different method categories), and additional methods identified by the FDA as they become available. Further, providers must have an easily accessible, transparent, and sufficiently expedient exceptions process that is not unduly burdensome on the individual or a provider (or other individuals acting as a patient’s authorized representative).

And while I can regale you with chapter and verse and citations of the legal precedent and language, it boils down to this:

• The AMA reported that medical practices spend an average of 2 business days a week per physician to comply with health plans’ inefficient and overused prior-authorization protocols.⁴ To keep up with the administrative burden, 2 out of 5 physicians (40%) employ staff members who work exclusively on tasks associated with prior authorization.⁴
• About 86% of practices reported an increased burden of prior authorizations in the last 5 years.⁵

Continue to: What is to be done?

I do have suggested solutions. Given the insurance industry’s complete lack of progress in voluntarily reducing the burdens of prior authorizations agreed to in their consensus statement with the AMA, American Hospital Association, America’s Health Insurance Plans, American Pharmacists Association, Blue Cross Blue Shield Association, and the Medical Group Management Association, I say, why not fine them? The AMA is calling on Congress to pass legislation that would codify much of the agreement, in which the above parties had already agreed that reforms were needed to reduce prior authorization burdens and enhance patient-centered care.⁶

A good model for enforcement via fines could be based on the old “incident to” rules of Medicare. These state that a physician needs to be “in the space” when advanced practice nurses or physician assistants see Medicare recipients. If they are not actually “in the space” they are subject to a fine. As a completely theoretical example, let’s say the claim was for $100. The practitioner would have to pay it back plus triple that amount in damages, or $400. They can also be fined up to $11,000 per claim and kick you out of Medicare and Medicaid. Take my example of Prolia from above…a single shot of Prolia is about $1,000. The insurer would theoretically have to pay $14,000/claim (the claim + triple damages + $11,000) if it was determined that the prior authorization was unnecessary. Seems about right to me. Or we could just sit the health insurance CEOs and their proxies in the corner on 2-foot-tall plastic Little Tikes® chairs for a “timeout” (dunce cap optional), like the outset of the article says.

Until the detrimental prior authorization process is challenged at all levels, we will continue to see and feel the effects of the harm it causes. Being able to drive change through advocacy and education is the best way we as clinicians can impact not just the future of health care but provide for the daily care of our patients who depend on and trust us to provide for their medical needs. We must be the impactors of change for ourselves, colleagues, staff, and profession if we are to really make advancements into the future.

Oh…and health insurance CEOs and their proxies, to get out of their “time-out” would still be entitled to one phone call to beg forgiveness from their mommies/daddies, priest/ rabbi/pastor, psychologist/psychiatrist/mystic healer, etc., but alas, the average wait time is an hour, and if anyone answers the phone, they have a grade school education used in following an irrelevant algorithm. ●

Before reading this editorial and concluding that the author (me) has lost his grip on reality, I would ask that you consider the facts I provide below and the ramifications incurred by your patients and practices, due to the misbehaviors adopted by the health insurance industry.

• Two of the most common issues discussed in today’s health care environment are revenue generation and provider/staff burnout.

While these issues are impacted by several factors, one of the most common denominators is increasing administrative workloads driven by non–revenue-generating activities. Consider this:

• A recent American Medical Association survey pointed out that during the course of the average workweek, a physician completes an average of 37 prior authorization requests. Physicians and their staff spend an average of 16.4 hours per week completing prior authorization requirements for patient medicines, procedures, and medical services that they may need.¹
• While physicians report that about 65% of prior authorizations take only 1 day, they report that 26% take 3 or more days.²

The potential significance of the generated delays

While this may not seem like a long time (other than the impact it has on staff workload), consider the impact this can have on the patient if the medication being requested is: PrEP, the morning after pill, or other contraceptives? The consequences of the delay or denial could be a lifetime living with HIV, or an unintended pregnancy. This is to say nothing on the larger impact to family, partners, and the potential social stigma faced by all.

Beyond the personal costs and costs within your practice associated with the additional workload, consider the financial costs. The average cost to complete a prior authorization remains the single highest cost for the health care industry at $13.40 per manual transaction, and $7.19 per partially electronic web portal transaction,³ meaning that if I did only one prescription per week, I probably would not mind, but at $13.40 per prior authorization, this burden amounts to millions, actually $767 million by recent estimates.³ Additionally, if you factor in the number of denials and potential follow-ups, this creates a significant amount of waste and spending.

Ultimately, in my experience, I have found that most prior authorizations are simply unnecessary. Here, I’ve picked key examples from just my own recent experiences:

1. My patient was denied access to a particular birth control pill she had been on successfully before, and my office was told she needed to try and fail on 5 different generic pills before she could be approved. However, the Affordable Care Act’s (ACA; aka Obamacare) Contraceptive Mandate requires coverage of all contraceptives determined to be most appropriate between a patient and their provider (see below).
2. A menopausal patient was denied coverage twice (electronically) for generic micronized progesterone, and I was asked to write a letter of appeal because the insurance company wanted me to use medroxyprogesterone acetate instead. Polling my nearby retail independent pharmacy, the total cost difference per year was $19.96 savings/year ($47.01 ‒ $27.05 = $19.96). My pharmacist did note it could have been a different amount at a large chain pharmacy. Really? I had to write a letter, following two denials, to save less than $20, for a full year!
3. A 78-year-old patient using Prolia for severe osteoporosis and preexisting fractures was delayed in getting her next Prolia injection due to a prior authorization snafu. She ended up with multiple additional fractures, a well-described effect of the increase in bone turnover when stopping or delaying this medication. She is now disabled.
4. A 94-year-old patient was sent an email reminder to get the medical practice to authorize a refill of ileostomy bags. The email went to spam, and the patient ran out of bags prior to a holiday weekend. I got them in 2 days on Amazon Prime. But who emails a 94-year-old? And ileostomy bags! When does anyone stop needing ileostomy bags?
5. I requested a prior authorization for Orilissa (clearly off label) because a severely progestogen-sensitive patient (augmented depression) with severe premenstrual dysphoric disorder requiring hospitalization was thought by her psychiatrist to be better off without menstrual periods. I completed the proper paperwork, two electronic appeals, and a letter of explanation including available references on the use of gonadotropin-releasing hormone analogues for such patients. I was then told I would need to have a peer-to-peer discussion, so I filled out that paperwork, which clearly noted that I am a board-certified reproductive endocrinologist. I got a phone call a few days later by a pleasant, young-sounding pediatric rheumatologist. Our interaction did not go well for him. This was not peer-to-peer!

Let us be clear, prior authorizations have nothing to do with patient care. In fact, they are solely about the money. We in ObGyn have mostly inexpensive and generic products, but even that fact has not lowered the excessive burden of the prior authorization process. In the case of contraception, whether you like the ACA or not it is the law, and it contains specific provisions regarding contraception. With the goals of providing broad access to patients and incentives to developers for new and novel contraceptive methods, these provisions require insurers to cover, without cost-sharing, women’s preventive services including the full range of FDA-approved contraceptives (currently 18 different method categories), and additional methods identified by the FDA as they become available. Further, providers must have an easily accessible, transparent, and sufficiently expedient exceptions process that is not unduly burdensome on the individual or a provider (or other individuals acting as a patient’s authorized representative).

And while I can regale you with chapter and verse and citations of the legal precedent and language, it boils down to this:

• The AMA reported that medical practices spend an average of 2 business days a week per physician to comply with health plans’ inefficient and overused prior-authorization protocols.⁴ To keep up with the administrative burden, 2 out of 5 physicians (40%) employ staff members who work exclusively on tasks associated with prior authorization.⁴
• About 86% of practices reported an increased burden of prior authorizations in the last 5 years.⁵

Continue to: What is to be done?

I do have suggested solutions. Given the insurance industry’s complete lack of progress in voluntarily reducing the burdens of prior authorizations agreed to in their consensus statement with the AMA, American Hospital Association, America’s Health Insurance Plans, American Pharmacists Association, Blue Cross Blue Shield Association, and the Medical Group Management Association, I say, why not fine them? The AMA is calling on Congress to pass legislation that would codify much of the agreement, in which the above parties had already agreed that reforms were needed to reduce prior authorization burdens and enhance patient-centered care.⁶

A good model for enforcement via fines could be based on the old “incident to” rules of Medicare. These state that a physician needs to be “in the space” when advanced practice nurses or physician assistants see Medicare recipients. If they are not actually “in the space” they are subject to a fine. As a completely theoretical example, let’s say the claim was for $100. The practitioner would have to pay it back plus triple that amount in damages, or $400. They can also be fined up to $11,000 per claim and kick you out of Medicare and Medicaid. Take my example of Prolia from above…a single shot of Prolia is about $1,000. The insurer would theoretically have to pay $14,000/claim (the claim + triple damages + $11,000) if it was determined that the prior authorization was unnecessary. Seems about right to me. Or we could just sit the health insurance CEOs and their proxies in the corner on 2-foot-tall plastic Little Tikes® chairs for a “timeout” (dunce cap optional), like the outset of the article says.

Until the detrimental prior authorization process is challenged at all levels, we will continue to see and feel the effects of the harm it causes. Being able to drive change through advocacy and education is the best way we as clinicians can impact not just the future of health care but provide for the daily care of our patients who depend on and trust us to provide for their medical needs. We must be the impactors of change for ourselves, colleagues, staff, and profession if we are to really make advancements into the future.

Oh…and health insurance CEOs and their proxies, to get out of their “time-out” would still be entitled to one phone call to beg forgiveness from their mommies/daddies, priest/ rabbi/pastor, psychologist/psychiatrist/mystic healer, etc., but alas, the average wait time is an hour, and if anyone answers the phone, they have a grade school education used in following an irrelevant algorithm. ●

People who build up high levels of immune cells from coronaviruses that cause the common cold could have some protection against COVID-19, according to a small study published Jan. 10 in Nature Communications.

Previous studies have shown that T cells created from other coronaviruses can recognize SARS-CoV-2, the virus that causes COVID-19. In the new study, researchers at Imperial College London found that the presence of these T cells at the time of COVID-19 exposure could reduce the chance of getting infected.

The findings could provide a blueprint for a second-generation, universal vaccine to prevent infection from COVID-19 variants, including Omicron and ones that crop up later.

“Being exposed to SARS-CoV-2 virus doesn’t always result in infection, and we’ve been keen to understand why,” Rhia Kundu, PhD, the lead study author from Imperial’s National Heart and Lung Institute, said in a statement.

People with higher levels of T cells from the common cold were less likely to become infected with COVID-19, the researchers found.

“While this is an important discovery, it is only one form of protection, and I would stress that no one should rely on this alone,” Dr. Kundu said. “Instead, the best way to protect yourself against COVID-19 is to be fully vaccinated, including getting your booster dose.”

For the study, Dr. Kundu and colleagues analyzed blood samples from 52 people who lived with someone with confirmed COVID-19 in September 2020. Among the 26 people who didn’t contract COVID-19, there were “significantly higher levels” of preexisting T cells from common cold coronaviruses, as compared with the 26 people who did become infected.

The T cells researched in the study are considered “cross-reactive” and can recognize the proteins of SARS-CoV-2. They offer protection by targeting proteins inside the SARS-CoV-2 virus, rather than the spike proteins on the surface that allow the virus to invade cells.

The current COVID-19 vaccines target the spike proteins, which are more likely to mutate than internal proteins, the researchers wrote. The Omicron variant, for instance, has numerous mutations on spike proteins that may allow it to evade vaccines.

The data suggest that the next step of COVID-19 vaccine development could focus on internal proteins, the researchers said, which could provide lasting protection because T-cell responses persist longer than antibody responses that fade within a few months of vaccination.

“New vaccines that include these conserved, internal proteins would therefore induce broadly protective T-cell responses that should protect against current and future SARS-CoV-2 variants,” Ajit Lalvani, MD, the senior study author and director of Imperial’s respiratory infections health protection research unit, said in the statement.

But more research is needed, the authors said, noting that the study had a small sample size and lacked ethnic diversity, which puts limits on the research.

A version of this article first appeared on WebMD.com

People who build up high levels of immune cells from coronaviruses that cause the common cold could have some protection against COVID-19, according to a small study published Jan. 10 in Nature Communications.

Previous studies have shown that T cells created from other coronaviruses can recognize SARS-CoV-2, the virus that causes COVID-19. In the new study, researchers at Imperial College London found that the presence of these T cells at the time of COVID-19 exposure could reduce the chance of getting infected.

The findings could provide a blueprint for a second-generation, universal vaccine to prevent infection from COVID-19 variants, including Omicron and ones that crop up later.

“Being exposed to SARS-CoV-2 virus doesn’t always result in infection, and we’ve been keen to understand why,” Rhia Kundu, PhD, the lead study author from Imperial’s National Heart and Lung Institute, said in a statement.

People with higher levels of T cells from the common cold were less likely to become infected with COVID-19, the researchers found.

“While this is an important discovery, it is only one form of protection, and I would stress that no one should rely on this alone,” Dr. Kundu said. “Instead, the best way to protect yourself against COVID-19 is to be fully vaccinated, including getting your booster dose.”

For the study, Dr. Kundu and colleagues analyzed blood samples from 52 people who lived with someone with confirmed COVID-19 in September 2020. Among the 26 people who didn’t contract COVID-19, there were “significantly higher levels” of preexisting T cells from common cold coronaviruses, as compared with the 26 people who did become infected.

The T cells researched in the study are considered “cross-reactive” and can recognize the proteins of SARS-CoV-2. They offer protection by targeting proteins inside the SARS-CoV-2 virus, rather than the spike proteins on the surface that allow the virus to invade cells.

The current COVID-19 vaccines target the spike proteins, which are more likely to mutate than internal proteins, the researchers wrote. The Omicron variant, for instance, has numerous mutations on spike proteins that may allow it to evade vaccines.

The data suggest that the next step of COVID-19 vaccine development could focus on internal proteins, the researchers said, which could provide lasting protection because T-cell responses persist longer than antibody responses that fade within a few months of vaccination.

“New vaccines that include these conserved, internal proteins would therefore induce broadly protective T-cell responses that should protect against current and future SARS-CoV-2 variants,” Ajit Lalvani, MD, the senior study author and director of Imperial’s respiratory infections health protection research unit, said in the statement.

But more research is needed, the authors said, noting that the study had a small sample size and lacked ethnic diversity, which puts limits on the research.

A version of this article first appeared on WebMD.com

People who build up high levels of immune cells from coronaviruses that cause the common cold could have some protection against COVID-19, according to a small study published Jan. 10 in Nature Communications.

Previous studies have shown that T cells created from other coronaviruses can recognize SARS-CoV-2, the virus that causes COVID-19. In the new study, researchers at Imperial College London found that the presence of these T cells at the time of COVID-19 exposure could reduce the chance of getting infected.

The findings could provide a blueprint for a second-generation, universal vaccine to prevent infection from COVID-19 variants, including Omicron and ones that crop up later.

“Being exposed to SARS-CoV-2 virus doesn’t always result in infection, and we’ve been keen to understand why,” Rhia Kundu, PhD, the lead study author from Imperial’s National Heart and Lung Institute, said in a statement.

People with higher levels of T cells from the common cold were less likely to become infected with COVID-19, the researchers found.

“While this is an important discovery, it is only one form of protection, and I would stress that no one should rely on this alone,” Dr. Kundu said. “Instead, the best way to protect yourself against COVID-19 is to be fully vaccinated, including getting your booster dose.”

For the study, Dr. Kundu and colleagues analyzed blood samples from 52 people who lived with someone with confirmed COVID-19 in September 2020. Among the 26 people who didn’t contract COVID-19, there were “significantly higher levels” of preexisting T cells from common cold coronaviruses, as compared with the 26 people who did become infected.

The T cells researched in the study are considered “cross-reactive” and can recognize the proteins of SARS-CoV-2. They offer protection by targeting proteins inside the SARS-CoV-2 virus, rather than the spike proteins on the surface that allow the virus to invade cells.

The current COVID-19 vaccines target the spike proteins, which are more likely to mutate than internal proteins, the researchers wrote. The Omicron variant, for instance, has numerous mutations on spike proteins that may allow it to evade vaccines.

The data suggest that the next step of COVID-19 vaccine development could focus on internal proteins, the researchers said, which could provide lasting protection because T-cell responses persist longer than antibody responses that fade within a few months of vaccination.

“New vaccines that include these conserved, internal proteins would therefore induce broadly protective T-cell responses that should protect against current and future SARS-CoV-2 variants,” Ajit Lalvani, MD, the senior study author and director of Imperial’s respiratory infections health protection research unit, said in the statement.

But more research is needed, the authors said, noting that the study had a small sample size and lacked ethnic diversity, which puts limits on the research.

A version of this article first appeared on WebMD.com

Some COVID-19 rapid antigen home test kits are much easier to use than others, according to an analysis by ECRI, an independent, nonprofit patient safety organization.

ECRI evaluated seven rapid COVID-19 antigen tests available for purchase online and in retail stores since December.

None of the tests were rated as “excellent” in terms of usability and some had “noteworthy” usability concerns, the company said.

If a test is hard to use, “chances are that you may miss a step or not follow the right order, or contaminate the testing area and that can definitely influence the accuracy of the test and lead to a wrong test result,” Marcus Schabacker, MD, PhD, president and CEO of ECRI, told this news organization.

To gauge usability, ECRI used the “industry-standard” system usability scale (SUS), which rates products on a scale of 0 to 100 with 100 being the easiest to use.

More than 30 points separated the top and bottom tests analyzed. The top performer was On/Go, followed by CareStart and Flowflex.

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

Some COVID-19 rapid antigen home test kits are much easier to use than others, according to an analysis by ECRI, an independent, nonprofit patient safety organization.

ECRI evaluated seven rapid COVID-19 antigen tests available for purchase online and in retail stores since December.

None of the tests were rated as “excellent” in terms of usability and some had “noteworthy” usability concerns, the company said.

If a test is hard to use, “chances are that you may miss a step or not follow the right order, or contaminate the testing area and that can definitely influence the accuracy of the test and lead to a wrong test result,” Marcus Schabacker, MD, PhD, president and CEO of ECRI, told this news organization.

To gauge usability, ECRI used the “industry-standard” system usability scale (SUS), which rates products on a scale of 0 to 100 with 100 being the easiest to use.

More than 30 points separated the top and bottom tests analyzed. The top performer was On/Go, followed by CareStart and Flowflex.

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

Some COVID-19 rapid antigen home test kits are much easier to use than others, according to an analysis by ECRI, an independent, nonprofit patient safety organization.

ECRI evaluated seven rapid COVID-19 antigen tests available for purchase online and in retail stores since December.

None of the tests were rated as “excellent” in terms of usability and some had “noteworthy” usability concerns, the company said.

If a test is hard to use, “chances are that you may miss a step or not follow the right order, or contaminate the testing area and that can definitely influence the accuracy of the test and lead to a wrong test result,” Marcus Schabacker, MD, PhD, president and CEO of ECRI, told this news organization.

To gauge usability, ECRI used the “industry-standard” system usability scale (SUS), which rates products on a scale of 0 to 100 with 100 being the easiest to use.

More than 30 points separated the top and bottom tests analyzed. The top performer was On/Go, followed by CareStart and Flowflex.

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

Doctors providing “fraudulent” COVID-19 information became a hot-button issue for physicians responding to Medscape’s recent article, "Shouldn’t Doctors Who Spread False COVID-19 Information Lose Their Licenses?”

COVID-19 safety recommendations are set by mainstream medical organizations as new information becomes available, but some doctors consistently oppose advice from the Centers for Disease Control and Prevention and other medical authorities. These physicians often promote off-label, unapproved use of medications for COVID-19 and/or contradict mainstream safety guidelines such as vaccines, masks, and social distancing.

Some medical organizations are concerned that these doctors are hampering efforts to control the highly contagious coronavirus and are, at worst, placing lives in danger with their contrarian views that can spread like wildfire on social media sites. Their words are often used by those who refuse to be vaccinated or wear masks.

State licensing boards have mostly refused to discipline these doctors for making false and/or misleading claims, but as the virus spreads, there are calls to take action against them. However, others worry that such actions would violate free speech and critical thought.

Medscape recently took on the question of whether doctors should lose their licenses for spreading misinformation and disinformation about COVID-19, which spurred a strong response from clinician readers.
 

Yes, those doctors are doing wrong

Several physicians took a strong stand against their fellow doctors who are spreading misinformation about COVID-19.

One doctor endorsed the idea of removing licenses for spreading misinformation and called for criminal prosecution: “It should certainly be grounds for cancellation of all licensing (after appropriate examination to rule out acute psychotic episodes, dementia, tumor, etc.) and very likely [include] a charge of manslaughter.”

Another health care provider said, “A person who does not accept science should not, of course, be allowed to practice medicine. One who argues publicly that vaccines and masks don’t work should be prosecuted for crimes ranging from reckless endangerment to attempted murder.”

One reader framed COVID-19 misinformers in stark terms: “These men and women are medical prostitutes. Their medical and surgical colleges [should] have a panel to track in-court testimony and the disinformation they spread ...”

“This is malpractice of the worst kind,” said a clinician. “Public health officials and science are quite clear on [the] best practices for safety during a pandemic, which is killing millions. This is a standard of care.”

“Medical Boards should suspend licenses and give the physician a chance to testify [about] the scientific basis for his comments,” added a health care provider. “Boards involve themselves in all kinds of perceived disciplinary infractions. We are in the midst of a lethal pandemic. I would think that would take precedence over many other issues?”

“I do believe that physicians have the responsibility to speak the truth and have scientifically displayed minds,” said a reader. “Not [to] promulgate misleading, false, and/or unverified information.”

“Any physician, who holds a license, should abide [by] government and state regulation,” asserted a doctor. “He should be disciplined by the board for spreading medical/public misinformation since he is creating potential harm to the population.”

One specialist insisted that “state boards do not do enough to restrict/limit the practice of physicians touting questionable therapies.”

“Any doctor who spreads false information about Covid is hurting our country, our individuals, and our economy and leading to needless deaths,” asserted a physician. “However, there are uncertainties, and where those exist, physicians [should] simply say ‘it is unknown.’”
 

No, those physicians have a right to speak their beliefs

However, many physicians worried that science and controversial thought were being muzzled.

“Absolutely no,” a doctor stated. “Who judges what is misinformation in this age where debate is canceled? Science advances with challenge, and it’s not about an authority dictating the allowable opinion.”

Another clinician claimed the “truth is very difficult to discern from less-than-truth in a country running on a profit-oriented economic ideology.”

One specialist warned that if disinformation doctors are held responsible, then “that means a lot of doctors” will be “gone” because “almost anything that is written or said about COVID can be contested.”

Another physician warned his colleagues about suppressing new ideas: “To condemn what we didn’t try, or purposefully ignore a different approach because [it] doesn’t agree with our opinion is suppression of information.”

Some doctors insisted the issue extended beyond medicine and into Constitutional freedoms. They also expressed their mistrust in the government to regulate physicians.

“There is a First Amendment in this country,” said one reader. “What you think is false may not be so. The people can listen to whoever they want to and make their own medical decisions. We do not need one iota more of politicizing medicine. Having an MD or DO does not mean you relinquish your First Amendment rights.”

“One of the fundamental problems with a system that allows government to ‘license’ physicians, or any other profession, is that politics inevitably turn to cronyism, and big businesses and wealthy people start controlling the government,” argued a doctor.

One clinician suggested enforcement against health food, drug company commercials, and talk shows: “What about all the [misinformation] at the health food stores and the like. Doctors of natural-whatever? Those info-commercials on tv. How many faxes do I get to ‘approve’ because ‘patients request’ braces and pain-treating expensive compounds advertised on TV? We tolerate those ... What about Dr. Oz and the docs on talk shows claiming BS?”
 

And the debate goes even further

Some physicians questioned the very notion of claiming “truth.”

“Nobody should be certain that they have the ‘absolute truth,’” said one reader. “In fact, the best clinical insights exceed so-called knowledge by at least one step.”

“Who can determine exactly what is truth?” asked another clinician. “For sure, the ‘Federal Government,’ who ‘is here to help you,’ is not qualified to make such determinations, and who are you to make such a suggestion as to remove someone’s license because they disagree with you? Give me a break!”

Another physician echoed that sentiment: “What’s true and false is often and certainly currently debatable. There are well-qualified physicians (with credentials such as the development of mRNA technology), virologists, and biostatisticians that have valid thoughts on this but do not necessarily agree with the drug company-sponsored journals and news channels (most of them). Their voices should be heard, and they should not lose their licenses. They are doing their work in good conscience.”

One reader commented that he wanted his “freedom of speech,” and offered this defiant advice: “You can take this license and shove it.”

Finally, a physician noted that the political climate has influenced medical directives: “If someone in a leadership role knowingly, and with intent, spread false information, that is wrong. However, during this global pandemic the active and the politics have combined. Red state no mandate, blue state mandate – what does that tell you about American leadership?”

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

Doctors providing “fraudulent” COVID-19 information became a hot-button issue for physicians responding to Medscape’s recent article, "Shouldn’t Doctors Who Spread False COVID-19 Information Lose Their Licenses?”

COVID-19 safety recommendations are set by mainstream medical organizations as new information becomes available, but some doctors consistently oppose advice from the Centers for Disease Control and Prevention and other medical authorities. These physicians often promote off-label, unapproved use of medications for COVID-19 and/or contradict mainstream safety guidelines such as vaccines, masks, and social distancing.

Some medical organizations are concerned that these doctors are hampering efforts to control the highly contagious coronavirus and are, at worst, placing lives in danger with their contrarian views that can spread like wildfire on social media sites. Their words are often used by those who refuse to be vaccinated or wear masks.

State licensing boards have mostly refused to discipline these doctors for making false and/or misleading claims, but as the virus spreads, there are calls to take action against them. However, others worry that such actions would violate free speech and critical thought.

Medscape recently took on the question of whether doctors should lose their licenses for spreading misinformation and disinformation about COVID-19, which spurred a strong response from clinician readers.
 

Yes, those doctors are doing wrong

Several physicians took a strong stand against their fellow doctors who are spreading misinformation about COVID-19.

One doctor endorsed the idea of removing licenses for spreading misinformation and called for criminal prosecution: “It should certainly be grounds for cancellation of all licensing (after appropriate examination to rule out acute psychotic episodes, dementia, tumor, etc.) and very likely [include] a charge of manslaughter.”

Another health care provider said, “A person who does not accept science should not, of course, be allowed to practice medicine. One who argues publicly that vaccines and masks don’t work should be prosecuted for crimes ranging from reckless endangerment to attempted murder.”

One reader framed COVID-19 misinformers in stark terms: “These men and women are medical prostitutes. Their medical and surgical colleges [should] have a panel to track in-court testimony and the disinformation they spread ...”

“This is malpractice of the worst kind,” said a clinician. “Public health officials and science are quite clear on [the] best practices for safety during a pandemic, which is killing millions. This is a standard of care.”

“Medical Boards should suspend licenses and give the physician a chance to testify [about] the scientific basis for his comments,” added a health care provider. “Boards involve themselves in all kinds of perceived disciplinary infractions. We are in the midst of a lethal pandemic. I would think that would take precedence over many other issues?”

“I do believe that physicians have the responsibility to speak the truth and have scientifically displayed minds,” said a reader. “Not [to] promulgate misleading, false, and/or unverified information.”

“Any physician, who holds a license, should abide [by] government and state regulation,” asserted a doctor. “He should be disciplined by the board for spreading medical/public misinformation since he is creating potential harm to the population.”

One specialist insisted that “state boards do not do enough to restrict/limit the practice of physicians touting questionable therapies.”

“Any doctor who spreads false information about Covid is hurting our country, our individuals, and our economy and leading to needless deaths,” asserted a physician. “However, there are uncertainties, and where those exist, physicians [should] simply say ‘it is unknown.’”
 

No, those physicians have a right to speak their beliefs

However, many physicians worried that science and controversial thought were being muzzled.

“Absolutely no,” a doctor stated. “Who judges what is misinformation in this age where debate is canceled? Science advances with challenge, and it’s not about an authority dictating the allowable opinion.”

Another clinician claimed the “truth is very difficult to discern from less-than-truth in a country running on a profit-oriented economic ideology.”

One specialist warned that if disinformation doctors are held responsible, then “that means a lot of doctors” will be “gone” because “almost anything that is written or said about COVID can be contested.”

Another physician warned his colleagues about suppressing new ideas: “To condemn what we didn’t try, or purposefully ignore a different approach because [it] doesn’t agree with our opinion is suppression of information.”

Some doctors insisted the issue extended beyond medicine and into Constitutional freedoms. They also expressed their mistrust in the government to regulate physicians.

“There is a First Amendment in this country,” said one reader. “What you think is false may not be so. The people can listen to whoever they want to and make their own medical decisions. We do not need one iota more of politicizing medicine. Having an MD or DO does not mean you relinquish your First Amendment rights.”

“One of the fundamental problems with a system that allows government to ‘license’ physicians, or any other profession, is that politics inevitably turn to cronyism, and big businesses and wealthy people start controlling the government,” argued a doctor.

One clinician suggested enforcement against health food, drug company commercials, and talk shows: “What about all the [misinformation] at the health food stores and the like. Doctors of natural-whatever? Those info-commercials on tv. How many faxes do I get to ‘approve’ because ‘patients request’ braces and pain-treating expensive compounds advertised on TV? We tolerate those ... What about Dr. Oz and the docs on talk shows claiming BS?”
 

And the debate goes even further

Some physicians questioned the very notion of claiming “truth.”

“Nobody should be certain that they have the ‘absolute truth,’” said one reader. “In fact, the best clinical insights exceed so-called knowledge by at least one step.”

“Who can determine exactly what is truth?” asked another clinician. “For sure, the ‘Federal Government,’ who ‘is here to help you,’ is not qualified to make such determinations, and who are you to make such a suggestion as to remove someone’s license because they disagree with you? Give me a break!”

Another physician echoed that sentiment: “What’s true and false is often and certainly currently debatable. There are well-qualified physicians (with credentials such as the development of mRNA technology), virologists, and biostatisticians that have valid thoughts on this but do not necessarily agree with the drug company-sponsored journals and news channels (most of them). Their voices should be heard, and they should not lose their licenses. They are doing their work in good conscience.”

One reader commented that he wanted his “freedom of speech,” and offered this defiant advice: “You can take this license and shove it.”

Finally, a physician noted that the political climate has influenced medical directives: “If someone in a leadership role knowingly, and with intent, spread false information, that is wrong. However, during this global pandemic the active and the politics have combined. Red state no mandate, blue state mandate – what does that tell you about American leadership?”

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

Doctors providing “fraudulent” COVID-19 information became a hot-button issue for physicians responding to Medscape’s recent article, "Shouldn’t Doctors Who Spread False COVID-19 Information Lose Their Licenses?”

COVID-19 safety recommendations are set by mainstream medical organizations as new information becomes available, but some doctors consistently oppose advice from the Centers for Disease Control and Prevention and other medical authorities. These physicians often promote off-label, unapproved use of medications for COVID-19 and/or contradict mainstream safety guidelines such as vaccines, masks, and social distancing.

Some medical organizations are concerned that these doctors are hampering efforts to control the highly contagious coronavirus and are, at worst, placing lives in danger with their contrarian views that can spread like wildfire on social media sites. Their words are often used by those who refuse to be vaccinated or wear masks.

State licensing boards have mostly refused to discipline these doctors for making false and/or misleading claims, but as the virus spreads, there are calls to take action against them. However, others worry that such actions would violate free speech and critical thought.

Medscape recently took on the question of whether doctors should lose their licenses for spreading misinformation and disinformation about COVID-19, which spurred a strong response from clinician readers.
 

Yes, those doctors are doing wrong

Several physicians took a strong stand against their fellow doctors who are spreading misinformation about COVID-19.

One doctor endorsed the idea of removing licenses for spreading misinformation and called for criminal prosecution: “It should certainly be grounds for cancellation of all licensing (after appropriate examination to rule out acute psychotic episodes, dementia, tumor, etc.) and very likely [include] a charge of manslaughter.”

Another health care provider said, “A person who does not accept science should not, of course, be allowed to practice medicine. One who argues publicly that vaccines and masks don’t work should be prosecuted for crimes ranging from reckless endangerment to attempted murder.”

One reader framed COVID-19 misinformers in stark terms: “These men and women are medical prostitutes. Their medical and surgical colleges [should] have a panel to track in-court testimony and the disinformation they spread ...”

“This is malpractice of the worst kind,” said a clinician. “Public health officials and science are quite clear on [the] best practices for safety during a pandemic, which is killing millions. This is a standard of care.”

“Medical Boards should suspend licenses and give the physician a chance to testify [about] the scientific basis for his comments,” added a health care provider. “Boards involve themselves in all kinds of perceived disciplinary infractions. We are in the midst of a lethal pandemic. I would think that would take precedence over many other issues?”

“I do believe that physicians have the responsibility to speak the truth and have scientifically displayed minds,” said a reader. “Not [to] promulgate misleading, false, and/or unverified information.”

“Any physician, who holds a license, should abide [by] government and state regulation,” asserted a doctor. “He should be disciplined by the board for spreading medical/public misinformation since he is creating potential harm to the population.”

One specialist insisted that “state boards do not do enough to restrict/limit the practice of physicians touting questionable therapies.”

“Any doctor who spreads false information about Covid is hurting our country, our individuals, and our economy and leading to needless deaths,” asserted a physician. “However, there are uncertainties, and where those exist, physicians [should] simply say ‘it is unknown.’”
 

No, those physicians have a right to speak their beliefs

However, many physicians worried that science and controversial thought were being muzzled.

“Absolutely no,” a doctor stated. “Who judges what is misinformation in this age where debate is canceled? Science advances with challenge, and it’s not about an authority dictating the allowable opinion.”

Another clinician claimed the “truth is very difficult to discern from less-than-truth in a country running on a profit-oriented economic ideology.”

One specialist warned that if disinformation doctors are held responsible, then “that means a lot of doctors” will be “gone” because “almost anything that is written or said about COVID can be contested.”

Another physician warned his colleagues about suppressing new ideas: “To condemn what we didn’t try, or purposefully ignore a different approach because [it] doesn’t agree with our opinion is suppression of information.”

Some doctors insisted the issue extended beyond medicine and into Constitutional freedoms. They also expressed their mistrust in the government to regulate physicians.

“There is a First Amendment in this country,” said one reader. “What you think is false may not be so. The people can listen to whoever they want to and make their own medical decisions. We do not need one iota more of politicizing medicine. Having an MD or DO does not mean you relinquish your First Amendment rights.”

“One of the fundamental problems with a system that allows government to ‘license’ physicians, or any other profession, is that politics inevitably turn to cronyism, and big businesses and wealthy people start controlling the government,” argued a doctor.

One clinician suggested enforcement against health food, drug company commercials, and talk shows: “What about all the [misinformation] at the health food stores and the like. Doctors of natural-whatever? Those info-commercials on tv. How many faxes do I get to ‘approve’ because ‘patients request’ braces and pain-treating expensive compounds advertised on TV? We tolerate those ... What about Dr. Oz and the docs on talk shows claiming BS?”
 

And the debate goes even further

Some physicians questioned the very notion of claiming “truth.”

“Nobody should be certain that they have the ‘absolute truth,’” said one reader. “In fact, the best clinical insights exceed so-called knowledge by at least one step.”

“Who can determine exactly what is truth?” asked another clinician. “For sure, the ‘Federal Government,’ who ‘is here to help you,’ is not qualified to make such determinations, and who are you to make such a suggestion as to remove someone’s license because they disagree with you? Give me a break!”

Another physician echoed that sentiment: “What’s true and false is often and certainly currently debatable. There are well-qualified physicians (with credentials such as the development of mRNA technology), virologists, and biostatisticians that have valid thoughts on this but do not necessarily agree with the drug company-sponsored journals and news channels (most of them). Their voices should be heard, and they should not lose their licenses. They are doing their work in good conscience.”

One reader commented that he wanted his “freedom of speech,” and offered this defiant advice: “You can take this license and shove it.”

Finally, a physician noted that the political climate has influenced medical directives: “If someone in a leadership role knowingly, and with intent, spread false information, that is wrong. However, during this global pandemic the active and the politics have combined. Red state no mandate, blue state mandate – what does that tell you about American leadership?”

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

The EXALT Model-D single-use duodenoscope may be a cost-effective alternative to high-level disinfection (HLD) of reusable duodenoscopes, according to a new analysis.

The study compared the EXALT Model-D, HLD, culture-and-quarantine (CQ), and ethylene oxide sterilization (ETO). The results came from a simulated cohort of patients undergoing endoscopic retrograde cholangiopancreatography (ERCP) to treat choledocholithiasis.

Although EXALT was the costliest option and HLD the cheapest, EXALT produced the most quality-adjusted life years (QALYs) and allowed the hospital to decrease net costs, and sensitivity analysis showed that it was a better option than HLD over a range of willingness-to-pay values.

“When evaluating technologies based on cost-effectiveness and additionally in the context of TPT [transitional passthrough] or NTAP [new technology add-on payment], the EXALT approach meets typically used cost-effectiveness thresholds compared to all other evaluated strategies and should be considered for standard practice,” wrote the authors, who were led by Ananya Das, MD, of the Arizona Centers for Digestive Health, Gilbert. The study was published in Techniques and Innovations in Gastrointestinal Endoscopy.

Duodenoscope contamination has resulted in outbreaks of various multidrug-resistant organisms in hospital settings, which has led to the publication of various reprocessing guidelines. Although many hospitals have adopted HLD protocols, others use additional or alternative reprocessing methods such as CQ or ETO. Despite these efforts, a recent Food and Drug Administration study found that 1.9%-22% of samples taken from duodenoscopes tested positive for bacteria of concern, such as pathogens. Those and other findings have led some to suggest that it would be best to move away from HLD, and instead employ sterilizable or disposable endoscopes.

In another study, The EXALT Model-D (Boston Scientific) had been shown to be a good alternative to standard reusable duodenoscopes.

The researchers used a Markov-model to determine the cost-effectiveness of EXALT Model-D against other approaches in a simulated cohort. They found that EXALT Model-D created the most QALYs (21.9265) at the highest cost ($3,000), and HLD the fewest QALYs (21.8938) at the lowest cost ($962). Compared with HLD, the incremental cost-effectiveness ratio (ICER) of EXALT was $62,185, and $38,461 for ETO gas sterilization. CQ was dominated, indicating that it had a higher cost but was not more effective than HLD.

The researchers conducted a subanalysis of ERCP and Medicare patients to consider the recently approved TPT payment and the NTAP, in both hospital outpatient and inpatient settings. With TPT, EXALT had no cost after reimbursement, with a net saving of $962 per patient when compared with HLD, plus an increase in 0.033 QALYs (0.15%). The other procedures cost more and were less effective. With NTAP, EXALT had a net cost of $323 versus HLD, with a similar QALY benefit.

A Monte Carlo analysis of EXALT versus HLD found reductions in duodenoscope infection-related ICU admission (relative risk reduction, 0.996; 95% confidence interval, 0.936-1.0; number needed to treat, 79; 95% CI, 67-95) and death (RRR, 0.973; 95% CI, 0.552-0.998; number needed to treat, 556; 95% CI, 350-997).

In willingness-to-pay estimates from $50,000 to $100,000, EXALT was cost effective in 67.28% of trials with ICER under $100,000 per QALY.

The study did not consider medicolegal costs, which could lead to an underestimation of EXALT’s cost-effectiveness. The study also relied on available published information to determine cost per patient of hospital outbreaks in the United States and Europe since 2012, but the authors did not include costs of administrative sanctions, litigation, and poor publicity due to inconsistencies in the literature.

“While more research is needed to understand and quantify the determinants of the natural history after exposure to contaminated duodenoscopes, such as the risk of transmission and the subsequent development of serious clinical infections, this economic analysis demonstrates an approach using EXALT Model-D is cost effective in the U.S. health care system when compared to the currently utilized strategies of duodenoscope reprocessing,” the researchers concluded.

The study did not receive any funding. One of the authors is an employee and stockholder of Boston Scientific, which manufactures and markets EXALT. The other two authors have consulted for Boston Scientific.

The EXALT Model-D single-use duodenoscope may be a cost-effective alternative to high-level disinfection (HLD) of reusable duodenoscopes, according to a new analysis.

The study compared the EXALT Model-D, HLD, culture-and-quarantine (CQ), and ethylene oxide sterilization (ETO). The results came from a simulated cohort of patients undergoing endoscopic retrograde cholangiopancreatography (ERCP) to treat choledocholithiasis.

Although EXALT was the costliest option and HLD the cheapest, EXALT produced the most quality-adjusted life years (QALYs) and allowed the hospital to decrease net costs, and sensitivity analysis showed that it was a better option than HLD over a range of willingness-to-pay values.

“When evaluating technologies based on cost-effectiveness and additionally in the context of TPT [transitional passthrough] or NTAP [new technology add-on payment], the EXALT approach meets typically used cost-effectiveness thresholds compared to all other evaluated strategies and should be considered for standard practice,” wrote the authors, who were led by Ananya Das, MD, of the Arizona Centers for Digestive Health, Gilbert. The study was published in Techniques and Innovations in Gastrointestinal Endoscopy.

Duodenoscope contamination has resulted in outbreaks of various multidrug-resistant organisms in hospital settings, which has led to the publication of various reprocessing guidelines. Although many hospitals have adopted HLD protocols, others use additional or alternative reprocessing methods such as CQ or ETO. Despite these efforts, a recent Food and Drug Administration study found that 1.9%-22% of samples taken from duodenoscopes tested positive for bacteria of concern, such as pathogens. Those and other findings have led some to suggest that it would be best to move away from HLD, and instead employ sterilizable or disposable endoscopes.

In another study, The EXALT Model-D (Boston Scientific) had been shown to be a good alternative to standard reusable duodenoscopes.

The researchers used a Markov-model to determine the cost-effectiveness of EXALT Model-D against other approaches in a simulated cohort. They found that EXALT Model-D created the most QALYs (21.9265) at the highest cost ($3,000), and HLD the fewest QALYs (21.8938) at the lowest cost ($962). Compared with HLD, the incremental cost-effectiveness ratio (ICER) of EXALT was $62,185, and $38,461 for ETO gas sterilization. CQ was dominated, indicating that it had a higher cost but was not more effective than HLD.

The researchers conducted a subanalysis of ERCP and Medicare patients to consider the recently approved TPT payment and the NTAP, in both hospital outpatient and inpatient settings. With TPT, EXALT had no cost after reimbursement, with a net saving of $962 per patient when compared with HLD, plus an increase in 0.033 QALYs (0.15%). The other procedures cost more and were less effective. With NTAP, EXALT had a net cost of $323 versus HLD, with a similar QALY benefit.

A Monte Carlo analysis of EXALT versus HLD found reductions in duodenoscope infection-related ICU admission (relative risk reduction, 0.996; 95% confidence interval, 0.936-1.0; number needed to treat, 79; 95% CI, 67-95) and death (RRR, 0.973; 95% CI, 0.552-0.998; number needed to treat, 556; 95% CI, 350-997).

In willingness-to-pay estimates from $50,000 to $100,000, EXALT was cost effective in 67.28% of trials with ICER under $100,000 per QALY.

The study did not consider medicolegal costs, which could lead to an underestimation of EXALT’s cost-effectiveness. The study also relied on available published information to determine cost per patient of hospital outbreaks in the United States and Europe since 2012, but the authors did not include costs of administrative sanctions, litigation, and poor publicity due to inconsistencies in the literature.

“While more research is needed to understand and quantify the determinants of the natural history after exposure to contaminated duodenoscopes, such as the risk of transmission and the subsequent development of serious clinical infections, this economic analysis demonstrates an approach using EXALT Model-D is cost effective in the U.S. health care system when compared to the currently utilized strategies of duodenoscope reprocessing,” the researchers concluded.

The study did not receive any funding. One of the authors is an employee and stockholder of Boston Scientific, which manufactures and markets EXALT. The other two authors have consulted for Boston Scientific.

The EXALT Model-D single-use duodenoscope may be a cost-effective alternative to high-level disinfection (HLD) of reusable duodenoscopes, according to a new analysis.

The study compared the EXALT Model-D, HLD, culture-and-quarantine (CQ), and ethylene oxide sterilization (ETO). The results came from a simulated cohort of patients undergoing endoscopic retrograde cholangiopancreatography (ERCP) to treat choledocholithiasis.

Although EXALT was the costliest option and HLD the cheapest, EXALT produced the most quality-adjusted life years (QALYs) and allowed the hospital to decrease net costs, and sensitivity analysis showed that it was a better option than HLD over a range of willingness-to-pay values.

“When evaluating technologies based on cost-effectiveness and additionally in the context of TPT [transitional passthrough] or NTAP [new technology add-on payment], the EXALT approach meets typically used cost-effectiveness thresholds compared to all other evaluated strategies and should be considered for standard practice,” wrote the authors, who were led by Ananya Das, MD, of the Arizona Centers for Digestive Health, Gilbert. The study was published in Techniques and Innovations in Gastrointestinal Endoscopy.

Duodenoscope contamination has resulted in outbreaks of various multidrug-resistant organisms in hospital settings, which has led to the publication of various reprocessing guidelines. Although many hospitals have adopted HLD protocols, others use additional or alternative reprocessing methods such as CQ or ETO. Despite these efforts, a recent Food and Drug Administration study found that 1.9%-22% of samples taken from duodenoscopes tested positive for bacteria of concern, such as pathogens. Those and other findings have led some to suggest that it would be best to move away from HLD, and instead employ sterilizable or disposable endoscopes.

In another study, The EXALT Model-D (Boston Scientific) had been shown to be a good alternative to standard reusable duodenoscopes.

The researchers used a Markov-model to determine the cost-effectiveness of EXALT Model-D against other approaches in a simulated cohort. They found that EXALT Model-D created the most QALYs (21.9265) at the highest cost ($3,000), and HLD the fewest QALYs (21.8938) at the lowest cost ($962). Compared with HLD, the incremental cost-effectiveness ratio (ICER) of EXALT was $62,185, and $38,461 for ETO gas sterilization. CQ was dominated, indicating that it had a higher cost but was not more effective than HLD.

The researchers conducted a subanalysis of ERCP and Medicare patients to consider the recently approved TPT payment and the NTAP, in both hospital outpatient and inpatient settings. With TPT, EXALT had no cost after reimbursement, with a net saving of $962 per patient when compared with HLD, plus an increase in 0.033 QALYs (0.15%). The other procedures cost more and were less effective. With NTAP, EXALT had a net cost of $323 versus HLD, with a similar QALY benefit.

A Monte Carlo analysis of EXALT versus HLD found reductions in duodenoscope infection-related ICU admission (relative risk reduction, 0.996; 95% confidence interval, 0.936-1.0; number needed to treat, 79; 95% CI, 67-95) and death (RRR, 0.973; 95% CI, 0.552-0.998; number needed to treat, 556; 95% CI, 350-997).

In willingness-to-pay estimates from $50,000 to $100,000, EXALT was cost effective in 67.28% of trials with ICER under $100,000 per QALY.

The study did not consider medicolegal costs, which could lead to an underestimation of EXALT’s cost-effectiveness. The study also relied on available published information to determine cost per patient of hospital outbreaks in the United States and Europe since 2012, but the authors did not include costs of administrative sanctions, litigation, and poor publicity due to inconsistencies in the literature.

“While more research is needed to understand and quantify the determinants of the natural history after exposure to contaminated duodenoscopes, such as the risk of transmission and the subsequent development of serious clinical infections, this economic analysis demonstrates an approach using EXALT Model-D is cost effective in the U.S. health care system when compared to the currently utilized strategies of duodenoscope reprocessing,” the researchers concluded.

The study did not receive any funding. One of the authors is an employee and stockholder of Boston Scientific, which manufactures and markets EXALT. The other two authors have consulted for Boston Scientific.

Medicare intends to limit coverage of the controversial Alzheimer’s drug aducanumab (Aduhelm, Biogen) via a special program intended to help assess how well this exorbitantly expensive medication works, federal officials announced Jan. 11.

On Dec. 20, 2021, Biogen announced a plan to reduce the annual U.S. cost of the drug by 50% – from $56,000 to $28,200 – as Centers for Medicare & Medicaid Services officials were deciding on Medicare’s coverage policy for the medication.

In making its proposed coverage decision, the CMS announced it will pay for aducanumab, a monoclonal antibody, under its coverage-with-evidence-development (CED) mechanism. In making its decision, the CMS approached aducanumab as the first of a potential new class of monoclonal antibodies for the treatment of Alzheimer’s disease. Food and Drug Administration–approved drugs in this class would be covered for those with Medicare only if they are enrolled in qualifying clinical trials, the CMS said. The agency will accept public comments on this decision for 30 days.  

In a statement, CMS Administrator Chiquita Brooks-LaSure said the agency is “committed to providing the American public with a clear, trusted, evidence-based decision that is made only after a thorough analysis of public feedback on the benefits and risks of coverage for Medicare patients.”

As previously reported, the FDA approved aducanumab on June 7, 2021, via an accelerated approval process. The approval, which set off a firestorm of controversy that included resignations of three FDA Peripheral and Central Nervous System Drugs Advisory Committee panel members, was granted based on the medication’s ability to reduce beta-amyloid plaque.

Under the accelerated approval mechanism, Biogen still must deliver solid scientific proof that aducanumab has clinically significant disease-modifying effects. However, the final evidence won’t be in any time soon. In its approval letter, the FDA set a 2030 deadline for a final report on this research.

 

‘Unusual but appropriate’ step

The Medicare decision marks something of a shift in the agency’s approach to paying for medications. On a call with reporters, Tamara Syrek Jensen, JD, director of CMS’ Coverage and Analysis Group, admitted that the agency had taken an “unusual but appropriate” step in trying to set a national policy regarding payment for a drug.

On the same call, Lee Fleisher, MD, CMS’ chief medical officer, addressed the challenges presented by aducanumab, given the serious need for treatments for Alzheimer’s disease. “As a practicing physician, I cannot overemphasize the need to understand the risks and benefits of a given treatment in order to better inform patients and their families,” Dr. Fleisher said. “We do know based on some of the evidence that there may be potential promise with this treatment. That’s why it is critical for us to pursue additional scientific evidence.”

The coverage-with-evidence program will allow Medicare to aid in gathering data, while protecting patients, Dr. Fleisher noted.

“CMS is using its authority provided by Congress to determine if the drug is considered reasonable and necessary, meaning that the benefits of improvement of cognition outweigh the harms in the Medicare population,” Dr. Fleisher said.
 

Biogen disappointed

Cambridge, Mass.–based Biogen urged the CMS to reconsider its approach to payment for aducanumab. In a statement, the company said Medicare should cover “the class of amyloid-directed therapies with the populations studied in the respective clinical trials and guided by expert recommendations for appropriate use.

“We believe Alzheimer’s patients should have access consistent with other therapies with FDA accelerated approval,” Biogen said in the release.

In the company’s view, the CED approach will “significantly limit patient access to an FDA-approved treatment, especially for underserved patients as evidenced in other CED determinations.

“CEDs can take months to years to initiate, and hundreds of Alzheimer’s patients – the majority of whom are Medicare beneficiaries – are progressing each day from mild to moderate disease stages, where treatment may no longer be an option,” Biogen said.

Drug makers had been worried about CMS opting for CED even before the draft decision was unveiled.
 

Others weigh in

BIO, the trade group for biotechnology companies, urged the CMS to provide access to aducanumab without excess restrictions.

There already are concerns among drug makers about CMS efforts “to impose new coverage barriers – and, in particular, coverage with evidence development,” Crystal Kuntz, vice president of policy and research at BIO, and Andy Cosgrove, the organization’s senior director for policy and research, noted in a July 2021 comment about the aducanumab review.

Medicare should instead continue to provide access to medicines for indications that the FDA has approved, with additional flexibility for off-label indications of cancer drugs, they noted. “We believe this should continue to be the case, to ensure that vulnerable Medicare beneficiaries have necessary access to life-altering and lifesaving medications,” the BIO officials wrote.

However, the CMS also received many pleas from physicians asking the agency to limit use of aducanumab at least until there is evidence that it produces a significant clinical benefit.

In a press release, Howard Fillit, MD, cofounder and chief science officer of the Alzheimer’s Drug Discovery Foundation, applauded the decision, describing it as “the right call.

“This decision supports conducting additional clinical trials, which are needed to obtain further insights into the clinical efficacy and safety profile of this drug in real-world populations. This decision has implications for other drugs in this class in late-stage development. If these trials show more clear and robust clinical efficacy, then it is possible the FDA will give these amyloid monoclonal antibodies full approval, and Medicare would be likely to provide full payment,” he added.

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

Medicare intends to limit coverage of the controversial Alzheimer’s drug aducanumab (Aduhelm, Biogen) via a special program intended to help assess how well this exorbitantly expensive medication works, federal officials announced Jan. 11.

On Dec. 20, 2021, Biogen announced a plan to reduce the annual U.S. cost of the drug by 50% – from $56,000 to $28,200 – as Centers for Medicare & Medicaid Services officials were deciding on Medicare’s coverage policy for the medication.

In making its proposed coverage decision, the CMS announced it will pay for aducanumab, a monoclonal antibody, under its coverage-with-evidence-development (CED) mechanism. In making its decision, the CMS approached aducanumab as the first of a potential new class of monoclonal antibodies for the treatment of Alzheimer’s disease. Food and Drug Administration–approved drugs in this class would be covered for those with Medicare only if they are enrolled in qualifying clinical trials, the CMS said. The agency will accept public comments on this decision for 30 days.  

In a statement, CMS Administrator Chiquita Brooks-LaSure said the agency is “committed to providing the American public with a clear, trusted, evidence-based decision that is made only after a thorough analysis of public feedback on the benefits and risks of coverage for Medicare patients.”

As previously reported, the FDA approved aducanumab on June 7, 2021, via an accelerated approval process. The approval, which set off a firestorm of controversy that included resignations of three FDA Peripheral and Central Nervous System Drugs Advisory Committee panel members, was granted based on the medication’s ability to reduce beta-amyloid plaque.

Under the accelerated approval mechanism, Biogen still must deliver solid scientific proof that aducanumab has clinically significant disease-modifying effects. However, the final evidence won’t be in any time soon. In its approval letter, the FDA set a 2030 deadline for a final report on this research.

 

‘Unusual but appropriate’ step

The Medicare decision marks something of a shift in the agency’s approach to paying for medications. On a call with reporters, Tamara Syrek Jensen, JD, director of CMS’ Coverage and Analysis Group, admitted that the agency had taken an “unusual but appropriate” step in trying to set a national policy regarding payment for a drug.

On the same call, Lee Fleisher, MD, CMS’ chief medical officer, addressed the challenges presented by aducanumab, given the serious need for treatments for Alzheimer’s disease. “As a practicing physician, I cannot overemphasize the need to understand the risks and benefits of a given treatment in order to better inform patients and their families,” Dr. Fleisher said. “We do know based on some of the evidence that there may be potential promise with this treatment. That’s why it is critical for us to pursue additional scientific evidence.”

The coverage-with-evidence program will allow Medicare to aid in gathering data, while protecting patients, Dr. Fleisher noted.

“CMS is using its authority provided by Congress to determine if the drug is considered reasonable and necessary, meaning that the benefits of improvement of cognition outweigh the harms in the Medicare population,” Dr. Fleisher said.
 

Biogen disappointed

Cambridge, Mass.–based Biogen urged the CMS to reconsider its approach to payment for aducanumab. In a statement, the company said Medicare should cover “the class of amyloid-directed therapies with the populations studied in the respective clinical trials and guided by expert recommendations for appropriate use.

“We believe Alzheimer’s patients should have access consistent with other therapies with FDA accelerated approval,” Biogen said in the release.

In the company’s view, the CED approach will “significantly limit patient access to an FDA-approved treatment, especially for underserved patients as evidenced in other CED determinations.

“CEDs can take months to years to initiate, and hundreds of Alzheimer’s patients – the majority of whom are Medicare beneficiaries – are progressing each day from mild to moderate disease stages, where treatment may no longer be an option,” Biogen said.

Drug makers had been worried about CMS opting for CED even before the draft decision was unveiled.
 

Others weigh in

BIO, the trade group for biotechnology companies, urged the CMS to provide access to aducanumab without excess restrictions.

There already are concerns among drug makers about CMS efforts “to impose new coverage barriers – and, in particular, coverage with evidence development,” Crystal Kuntz, vice president of policy and research at BIO, and Andy Cosgrove, the organization’s senior director for policy and research, noted in a July 2021 comment about the aducanumab review.

Medicare should instead continue to provide access to medicines for indications that the FDA has approved, with additional flexibility for off-label indications of cancer drugs, they noted. “We believe this should continue to be the case, to ensure that vulnerable Medicare beneficiaries have necessary access to life-altering and lifesaving medications,” the BIO officials wrote.

However, the CMS also received many pleas from physicians asking the agency to limit use of aducanumab at least until there is evidence that it produces a significant clinical benefit.

In a press release, Howard Fillit, MD, cofounder and chief science officer of the Alzheimer’s Drug Discovery Foundation, applauded the decision, describing it as “the right call.

“This decision supports conducting additional clinical trials, which are needed to obtain further insights into the clinical efficacy and safety profile of this drug in real-world populations. This decision has implications for other drugs in this class in late-stage development. If these trials show more clear and robust clinical efficacy, then it is possible the FDA will give these amyloid monoclonal antibodies full approval, and Medicare would be likely to provide full payment,” he added.

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

Medicare intends to limit coverage of the controversial Alzheimer’s drug aducanumab (Aduhelm, Biogen) via a special program intended to help assess how well this exorbitantly expensive medication works, federal officials announced Jan. 11.

On Dec. 20, 2021, Biogen announced a plan to reduce the annual U.S. cost of the drug by 50% – from $56,000 to $28,200 – as Centers for Medicare & Medicaid Services officials were deciding on Medicare’s coverage policy for the medication.

In making its proposed coverage decision, the CMS announced it will pay for aducanumab, a monoclonal antibody, under its coverage-with-evidence-development (CED) mechanism. In making its decision, the CMS approached aducanumab as the first of a potential new class of monoclonal antibodies for the treatment of Alzheimer’s disease. Food and Drug Administration–approved drugs in this class would be covered for those with Medicare only if they are enrolled in qualifying clinical trials, the CMS said. The agency will accept public comments on this decision for 30 days.  

In a statement, CMS Administrator Chiquita Brooks-LaSure said the agency is “committed to providing the American public with a clear, trusted, evidence-based decision that is made only after a thorough analysis of public feedback on the benefits and risks of coverage for Medicare patients.”

As previously reported, the FDA approved aducanumab on June 7, 2021, via an accelerated approval process. The approval, which set off a firestorm of controversy that included resignations of three FDA Peripheral and Central Nervous System Drugs Advisory Committee panel members, was granted based on the medication’s ability to reduce beta-amyloid plaque.

Under the accelerated approval mechanism, Biogen still must deliver solid scientific proof that aducanumab has clinically significant disease-modifying effects. However, the final evidence won’t be in any time soon. In its approval letter, the FDA set a 2030 deadline for a final report on this research.

 

‘Unusual but appropriate’ step

The Medicare decision marks something of a shift in the agency’s approach to paying for medications. On a call with reporters, Tamara Syrek Jensen, JD, director of CMS’ Coverage and Analysis Group, admitted that the agency had taken an “unusual but appropriate” step in trying to set a national policy regarding payment for a drug.

On the same call, Lee Fleisher, MD, CMS’ chief medical officer, addressed the challenges presented by aducanumab, given the serious need for treatments for Alzheimer’s disease. “As a practicing physician, I cannot overemphasize the need to understand the risks and benefits of a given treatment in order to better inform patients and their families,” Dr. Fleisher said. “We do know based on some of the evidence that there may be potential promise with this treatment. That’s why it is critical for us to pursue additional scientific evidence.”

The coverage-with-evidence program will allow Medicare to aid in gathering data, while protecting patients, Dr. Fleisher noted.

“CMS is using its authority provided by Congress to determine if the drug is considered reasonable and necessary, meaning that the benefits of improvement of cognition outweigh the harms in the Medicare population,” Dr. Fleisher said.
 

Biogen disappointed

Cambridge, Mass.–based Biogen urged the CMS to reconsider its approach to payment for aducanumab. In a statement, the company said Medicare should cover “the class of amyloid-directed therapies with the populations studied in the respective clinical trials and guided by expert recommendations for appropriate use.

“We believe Alzheimer’s patients should have access consistent with other therapies with FDA accelerated approval,” Biogen said in the release.

In the company’s view, the CED approach will “significantly limit patient access to an FDA-approved treatment, especially for underserved patients as evidenced in other CED determinations.

“CEDs can take months to years to initiate, and hundreds of Alzheimer’s patients – the majority of whom are Medicare beneficiaries – are progressing each day from mild to moderate disease stages, where treatment may no longer be an option,” Biogen said.

Drug makers had been worried about CMS opting for CED even before the draft decision was unveiled.
 

Others weigh in

BIO, the trade group for biotechnology companies, urged the CMS to provide access to aducanumab without excess restrictions.

There already are concerns among drug makers about CMS efforts “to impose new coverage barriers – and, in particular, coverage with evidence development,” Crystal Kuntz, vice president of policy and research at BIO, and Andy Cosgrove, the organization’s senior director for policy and research, noted in a July 2021 comment about the aducanumab review.

Medicare should instead continue to provide access to medicines for indications that the FDA has approved, with additional flexibility for off-label indications of cancer drugs, they noted. “We believe this should continue to be the case, to ensure that vulnerable Medicare beneficiaries have necessary access to life-altering and lifesaving medications,” the BIO officials wrote.

However, the CMS also received many pleas from physicians asking the agency to limit use of aducanumab at least until there is evidence that it produces a significant clinical benefit.

In a press release, Howard Fillit, MD, cofounder and chief science officer of the Alzheimer’s Drug Discovery Foundation, applauded the decision, describing it as “the right call.

“This decision supports conducting additional clinical trials, which are needed to obtain further insights into the clinical efficacy and safety profile of this drug in real-world populations. This decision has implications for other drugs in this class in late-stage development. If these trials show more clear and robust clinical efficacy, then it is possible the FDA will give these amyloid monoclonal antibodies full approval, and Medicare would be likely to provide full payment,” he added.

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

Almost 90% of treatment naive chronic lymphocytic leukemia/small lymphocytic lymphoma patients (33/37) had undetectable minimal residual disease (MRD) in both blood and bone marrow when the second-generation Bruton’s tyrosine kinase (BTK) inhibitor zanubrutinib (Brukinsa) was added on to obinutuzumab and venetoclax for a median of just 10 treatment cycles.

Treatment was stopped in the single-arm phase 2 trial when patients reached undetectable MRD, a novel use of MRD to guide treatment duration. At a median of 16 months after discontinuation, MRD remained undetectable in 31 of 33 patients (94%).

The team also found that a reduction to 1/400 of baseline MRD (delta-MRD400) by day 1 of cycle five predicted undetectable bone marrow MRD within eight treatment cycles.

delta-MRD400 is “a potential biomarker” to identify patients who’ll do well with a shorter treatment and flag others who require longer courses of therapy, said investigators led by Jacob Soumerai, MD, a hematologist/oncologist at Massachusetts General Hospital, Boston.

Overall, the results “are highly encouraging,” they said, with efficacy and safety comparing favorably to trials that added other BTK inhibitors – namely ibrutinib and acalabrutinib – to the standard obinutuzumab/venetoclax backbone, with a shorter treatment duration.

They said the novel triplet warrants further study in the first line and noted that they also “plan to prospectively validate early-MRD-response kinetics as a biomarker to guide treatment duration.” The study was published recently in The Lancet Haematology.

Two editorialists – Davide Rossi, MD, PhD, and Joyce Marques De Almeida, both of the of the Oncology Institute of Southern Switzerland, Bellinzona – were encouraged by the findings and wanted future research to assess how well MRD-guided treatment duration works in patients with tumor protein p53-disrupted disease, who “benefit less from time-limited therapies” then patients with wild-type TP53; the trial was too small to address the issue.

There was a two-cycle lead-in with zanubrutinib and obinutuzumab then venetoclax ramp-up starting at cycle 3, with each cycle running 28 days.

Zanubrutinib is approved in the U.S. for mantle cell lymphoma, Waldenström’s macroglobulinemia, and marginal zone lymphoma.

In a previous phase 2 trial of ibrutinib add-on to venetoclax-obinutuzumab for 14 cycles followed by ibrutinib monotherapy, the rate of undetectable MRD in both peripheral blood and bone marrow was 67%. The rate of bone marrow undetectable MRD was 77% in another phase 2 trial of acalabrutinib, venetoclax, and obinutuzumab for at least 15 cycles.

Dr. Soumerai and his team cautioned, however, that “comparisons across trials are fraught with selection bias resulting in differences in treated patient populations, and randomized data are needed to establish the optimal BTK inhibitor to combine with venetoclax with or without obinutuzumab, and to establish whether” the zanubrutinib triplet “improves progression-free survival and overall survival compared with current standard first-line therapy.”

There was grade 3 or worse neutropenia in 18% of subjects (7/39), one episode of febrile neutropenia (3%), lung infections in three patients (8%) patients, and five cases of hypertension (13%).

The editorialists characterized the numbers as low and the regimen as well tolerated. Past studies of ibrutinib, a first generation BTK, with venetoclax and obinutuzumab have pegged grade 3 or worse neutropenia at 56% and the hypertension incidence at 48%.

Granulocyte colony-stimulating factor administration “could partially account for the low incidence of severe neutropenia” in the trial, the investigators said.

The study was funded by zanubrutinib marketer Beigene as well as Genentech, the National Cancer Institute, and others. Many of the authors had industry ties, including Dr. Soumerai who reported being a consultant and researcher for Beigene and other companies. Dr. Rossi reported honoraria and research grants from AbbVie, AstraZeneca, and Janssen.

Almost 90% of treatment naive chronic lymphocytic leukemia/small lymphocytic lymphoma patients (33/37) had undetectable minimal residual disease (MRD) in both blood and bone marrow when the second-generation Bruton’s tyrosine kinase (BTK) inhibitor zanubrutinib (Brukinsa) was added on to obinutuzumab and venetoclax for a median of just 10 treatment cycles.

Treatment was stopped in the single-arm phase 2 trial when patients reached undetectable MRD, a novel use of MRD to guide treatment duration. At a median of 16 months after discontinuation, MRD remained undetectable in 31 of 33 patients (94%).

The team also found that a reduction to 1/400 of baseline MRD (delta-MRD400) by day 1 of cycle five predicted undetectable bone marrow MRD within eight treatment cycles.

delta-MRD400 is “a potential biomarker” to identify patients who’ll do well with a shorter treatment and flag others who require longer courses of therapy, said investigators led by Jacob Soumerai, MD, a hematologist/oncologist at Massachusetts General Hospital, Boston.

Overall, the results “are highly encouraging,” they said, with efficacy and safety comparing favorably to trials that added other BTK inhibitors – namely ibrutinib and acalabrutinib – to the standard obinutuzumab/venetoclax backbone, with a shorter treatment duration.

They said the novel triplet warrants further study in the first line and noted that they also “plan to prospectively validate early-MRD-response kinetics as a biomarker to guide treatment duration.” The study was published recently in The Lancet Haematology.

Two editorialists – Davide Rossi, MD, PhD, and Joyce Marques De Almeida, both of the of the Oncology Institute of Southern Switzerland, Bellinzona – were encouraged by the findings and wanted future research to assess how well MRD-guided treatment duration works in patients with tumor protein p53-disrupted disease, who “benefit less from time-limited therapies” then patients with wild-type TP53; the trial was too small to address the issue.

There was a two-cycle lead-in with zanubrutinib and obinutuzumab then venetoclax ramp-up starting at cycle 3, with each cycle running 28 days.

Zanubrutinib is approved in the U.S. for mantle cell lymphoma, Waldenström’s macroglobulinemia, and marginal zone lymphoma.

In a previous phase 2 trial of ibrutinib add-on to venetoclax-obinutuzumab for 14 cycles followed by ibrutinib monotherapy, the rate of undetectable MRD in both peripheral blood and bone marrow was 67%. The rate of bone marrow undetectable MRD was 77% in another phase 2 trial of acalabrutinib, venetoclax, and obinutuzumab for at least 15 cycles.

Dr. Soumerai and his team cautioned, however, that “comparisons across trials are fraught with selection bias resulting in differences in treated patient populations, and randomized data are needed to establish the optimal BTK inhibitor to combine with venetoclax with or without obinutuzumab, and to establish whether” the zanubrutinib triplet “improves progression-free survival and overall survival compared with current standard first-line therapy.”

There was grade 3 or worse neutropenia in 18% of subjects (7/39), one episode of febrile neutropenia (3%), lung infections in three patients (8%) patients, and five cases of hypertension (13%).

The editorialists characterized the numbers as low and the regimen as well tolerated. Past studies of ibrutinib, a first generation BTK, with venetoclax and obinutuzumab have pegged grade 3 or worse neutropenia at 56% and the hypertension incidence at 48%.

Granulocyte colony-stimulating factor administration “could partially account for the low incidence of severe neutropenia” in the trial, the investigators said.

The study was funded by zanubrutinib marketer Beigene as well as Genentech, the National Cancer Institute, and others. Many of the authors had industry ties, including Dr. Soumerai who reported being a consultant and researcher for Beigene and other companies. Dr. Rossi reported honoraria and research grants from AbbVie, AstraZeneca, and Janssen.

Almost 90% of treatment naive chronic lymphocytic leukemia/small lymphocytic lymphoma patients (33/37) had undetectable minimal residual disease (MRD) in both blood and bone marrow when the second-generation Bruton’s tyrosine kinase (BTK) inhibitor zanubrutinib (Brukinsa) was added on to obinutuzumab and venetoclax for a median of just 10 treatment cycles.

Treatment was stopped in the single-arm phase 2 trial when patients reached undetectable MRD, a novel use of MRD to guide treatment duration. At a median of 16 months after discontinuation, MRD remained undetectable in 31 of 33 patients (94%).

The team also found that a reduction to 1/400 of baseline MRD (delta-MRD400) by day 1 of cycle five predicted undetectable bone marrow MRD within eight treatment cycles.

delta-MRD400 is “a potential biomarker” to identify patients who’ll do well with a shorter treatment and flag others who require longer courses of therapy, said investigators led by Jacob Soumerai, MD, a hematologist/oncologist at Massachusetts General Hospital, Boston.

Overall, the results “are highly encouraging,” they said, with efficacy and safety comparing favorably to trials that added other BTK inhibitors – namely ibrutinib and acalabrutinib – to the standard obinutuzumab/venetoclax backbone, with a shorter treatment duration.

They said the novel triplet warrants further study in the first line and noted that they also “plan to prospectively validate early-MRD-response kinetics as a biomarker to guide treatment duration.” The study was published recently in The Lancet Haematology.

Two editorialists – Davide Rossi, MD, PhD, and Joyce Marques De Almeida, both of the of the Oncology Institute of Southern Switzerland, Bellinzona – were encouraged by the findings and wanted future research to assess how well MRD-guided treatment duration works in patients with tumor protein p53-disrupted disease, who “benefit less from time-limited therapies” then patients with wild-type TP53; the trial was too small to address the issue.

There was a two-cycle lead-in with zanubrutinib and obinutuzumab then venetoclax ramp-up starting at cycle 3, with each cycle running 28 days.

Zanubrutinib is approved in the U.S. for mantle cell lymphoma, Waldenström’s macroglobulinemia, and marginal zone lymphoma.

In a previous phase 2 trial of ibrutinib add-on to venetoclax-obinutuzumab for 14 cycles followed by ibrutinib monotherapy, the rate of undetectable MRD in both peripheral blood and bone marrow was 67%. The rate of bone marrow undetectable MRD was 77% in another phase 2 trial of acalabrutinib, venetoclax, and obinutuzumab for at least 15 cycles.

Dr. Soumerai and his team cautioned, however, that “comparisons across trials are fraught with selection bias resulting in differences in treated patient populations, and randomized data are needed to establish the optimal BTK inhibitor to combine with venetoclax with or without obinutuzumab, and to establish whether” the zanubrutinib triplet “improves progression-free survival and overall survival compared with current standard first-line therapy.”

There was grade 3 or worse neutropenia in 18% of subjects (7/39), one episode of febrile neutropenia (3%), lung infections in three patients (8%) patients, and five cases of hypertension (13%).

The editorialists characterized the numbers as low and the regimen as well tolerated. Past studies of ibrutinib, a first generation BTK, with venetoclax and obinutuzumab have pegged grade 3 or worse neutropenia at 56% and the hypertension incidence at 48%.

Granulocyte colony-stimulating factor administration “could partially account for the low incidence of severe neutropenia” in the trial, the investigators said.

The study was funded by zanubrutinib marketer Beigene as well as Genentech, the National Cancer Institute, and others. Many of the authors had industry ties, including Dr. Soumerai who reported being a consultant and researcher for Beigene and other companies. Dr. Rossi reported honoraria and research grants from AbbVie, AstraZeneca, and Janssen.

An estimated 50% of children with atopic dermatitis (AD) struggle with sleep problems, with complaints that vary from sleep fragmentation to restlessness and limb movements, according to Stephen H. Sheldon, DO.

“They wake up frequently,” Dr. Sheldon, professor of pediatrics and neurology at Northwestern University, Chicago, said during the Revolutionizing Atopic Dermatitis symposium. “They may not stay up for long periods of time, but they move about often. There’s a loss of about 50 minutes of sleep per night in children with AD. This loss can result in significant sleep debt the following day. They have difficulty settling at night. Once they get into bed, they have difficulty falling asleep, and many of them have difficulty staying asleep.”

At the sleep medicine center at Lurie Children’s Hospital of Chicago, he and his colleagues have observed that some children with AD complain of difficulty with limb movements. “Part of the issue has been that they have been diagnosed with different sleep-related disorders, such as period limb movement disorder, restless leg syndrome, and growing pain,” Dr. Sheldon said. “Often, they do not know how to describe the manifestations of their leg discomfort in restless leg syndrome and period limb movement disorder and limb movements of sleep.”

Children who complain of growing pains say that their legs hurt, he continued. Sometimes they’ll say that they feel like spiders are crawling on their legs, or that their legs itch, but they often say they have pain in their legs that wakes them up and keeps them from keeping their legs still.

According to the American Academy of Sleep Medicine, periodic limb movement disorder of sleep is characterized by frequent limb movements that last at least 0.5 seconds and are separated by no more than 90 seconds. “They’re four movements in a row that are at least 5 seconds apart,” Dr. Sheldon said.

Interestingly, he added, children who have limb movement disorder have symptoms during the day, similar to adults. “But we see many children with periodic limb movements of sleep whose arms and legs are moving all night, and they don’t have many symptoms during the day.” These children may have difficulty falling or staying asleep, but do not fulfill all of the American Academy of Sleep Medicine criteria for diagnosis of periodic limb movement disorder, he added.

In 2018, Lourdes M. DelRosso, MD, EdD, of Seattle Children’s Hospital, and colleagues described a new sleep problem they termed restless sleep disorder: those who do not fit the criteria for any other sleep disorder but have daytime impairment.

“On video they have very frequent movements – more than five movements an hour of major body activity,” Dr. Sheldon explained. “They’ll move their trunk, their legs, and reposition themselves. We have found that there are many children who presented to the sleep disorder center with restless sleep, limb movement disorder, periodic limb movements of sleep, and daytime symptoms that would fulfill the criteria of periodic limb movement disorder but also have atopic dermatitis.”

Recently, Dr. Sheldon and his colleagues used polysomnographic variables to study children who presented to Lurie Children’s Hospital with AD and symptoms such as difficulty maintaining sleep and snoring with allergic rhinitis. They found that there were increased periods of being awake after the onset of sleep, “meaning the children fell asleep fairly easily in the beginning of the night but they had significant wake after they fell asleep,” he said. “They would wake up in the middle of the night and stay awake for long periods of time – either one long session or multiple shorter sessions throughout the night. They had increased total limb movements per hour of sleep. This means that their limb movements were greater than five events per hour of sleep and it resulted in restless sleep and limb movements that would fulfill the criteria of periodic limb movement disorder.”

Most of these children had mild to moderate AD, he continued. “We feel that the sensory afferent loop in these youngsters doesn’t really turn off completely when they’re asleep. This is ripe for further study, but it makes intuitive sense that if the sensory afferent loop continues during sleep, it may affect the arousal system significantly.”

Dr. Sheldon recommended that any child who presents with a diagnosis of periodic limb movement disorder, periodic limb movements of sleep, or restless sleep disorder should be evaluated for AD. “The treatment then, would first require differentiation between periodic limb movement disorder of sleep and AD. Both should be addressed at the same time in order to solve the child’s daytime AD problem as well as the sleep-related issues that occur with an AD diagnosis.”

He reported having no financial disclosures.

An estimated 50% of children with atopic dermatitis (AD) struggle with sleep problems, with complaints that vary from sleep fragmentation to restlessness and limb movements, according to Stephen H. Sheldon, DO.

“They wake up frequently,” Dr. Sheldon, professor of pediatrics and neurology at Northwestern University, Chicago, said during the Revolutionizing Atopic Dermatitis symposium. “They may not stay up for long periods of time, but they move about often. There’s a loss of about 50 minutes of sleep per night in children with AD. This loss can result in significant sleep debt the following day. They have difficulty settling at night. Once they get into bed, they have difficulty falling asleep, and many of them have difficulty staying asleep.”

At the sleep medicine center at Lurie Children’s Hospital of Chicago, he and his colleagues have observed that some children with AD complain of difficulty with limb movements. “Part of the issue has been that they have been diagnosed with different sleep-related disorders, such as period limb movement disorder, restless leg syndrome, and growing pain,” Dr. Sheldon said. “Often, they do not know how to describe the manifestations of their leg discomfort in restless leg syndrome and period limb movement disorder and limb movements of sleep.”

Children who complain of growing pains say that their legs hurt, he continued. Sometimes they’ll say that they feel like spiders are crawling on their legs, or that their legs itch, but they often say they have pain in their legs that wakes them up and keeps them from keeping their legs still.

According to the American Academy of Sleep Medicine, periodic limb movement disorder of sleep is characterized by frequent limb movements that last at least 0.5 seconds and are separated by no more than 90 seconds. “They’re four movements in a row that are at least 5 seconds apart,” Dr. Sheldon said.

Interestingly, he added, children who have limb movement disorder have symptoms during the day, similar to adults. “But we see many children with periodic limb movements of sleep whose arms and legs are moving all night, and they don’t have many symptoms during the day.” These children may have difficulty falling or staying asleep, but do not fulfill all of the American Academy of Sleep Medicine criteria for diagnosis of periodic limb movement disorder, he added.

In 2018, Lourdes M. DelRosso, MD, EdD, of Seattle Children’s Hospital, and colleagues described a new sleep problem they termed restless sleep disorder: those who do not fit the criteria for any other sleep disorder but have daytime impairment.

“On video they have very frequent movements – more than five movements an hour of major body activity,” Dr. Sheldon explained. “They’ll move their trunk, their legs, and reposition themselves. We have found that there are many children who presented to the sleep disorder center with restless sleep, limb movement disorder, periodic limb movements of sleep, and daytime symptoms that would fulfill the criteria of periodic limb movement disorder but also have atopic dermatitis.”

Recently, Dr. Sheldon and his colleagues used polysomnographic variables to study children who presented to Lurie Children’s Hospital with AD and symptoms such as difficulty maintaining sleep and snoring with allergic rhinitis. They found that there were increased periods of being awake after the onset of sleep, “meaning the children fell asleep fairly easily in the beginning of the night but they had significant wake after they fell asleep,” he said. “They would wake up in the middle of the night and stay awake for long periods of time – either one long session or multiple shorter sessions throughout the night. They had increased total limb movements per hour of sleep. This means that their limb movements were greater than five events per hour of sleep and it resulted in restless sleep and limb movements that would fulfill the criteria of periodic limb movement disorder.”

Most of these children had mild to moderate AD, he continued. “We feel that the sensory afferent loop in these youngsters doesn’t really turn off completely when they’re asleep. This is ripe for further study, but it makes intuitive sense that if the sensory afferent loop continues during sleep, it may affect the arousal system significantly.”

Dr. Sheldon recommended that any child who presents with a diagnosis of periodic limb movement disorder, periodic limb movements of sleep, or restless sleep disorder should be evaluated for AD. “The treatment then, would first require differentiation between periodic limb movement disorder of sleep and AD. Both should be addressed at the same time in order to solve the child’s daytime AD problem as well as the sleep-related issues that occur with an AD diagnosis.”

He reported having no financial disclosures.

An estimated 50% of children with atopic dermatitis (AD) struggle with sleep problems, with complaints that vary from sleep fragmentation to restlessness and limb movements, according to Stephen H. Sheldon, DO.

“They wake up frequently,” Dr. Sheldon, professor of pediatrics and neurology at Northwestern University, Chicago, said during the Revolutionizing Atopic Dermatitis symposium. “They may not stay up for long periods of time, but they move about often. There’s a loss of about 50 minutes of sleep per night in children with AD. This loss can result in significant sleep debt the following day. They have difficulty settling at night. Once they get into bed, they have difficulty falling asleep, and many of them have difficulty staying asleep.”

At the sleep medicine center at Lurie Children’s Hospital of Chicago, he and his colleagues have observed that some children with AD complain of difficulty with limb movements. “Part of the issue has been that they have been diagnosed with different sleep-related disorders, such as period limb movement disorder, restless leg syndrome, and growing pain,” Dr. Sheldon said. “Often, they do not know how to describe the manifestations of their leg discomfort in restless leg syndrome and period limb movement disorder and limb movements of sleep.”

Children who complain of growing pains say that their legs hurt, he continued. Sometimes they’ll say that they feel like spiders are crawling on their legs, or that their legs itch, but they often say they have pain in their legs that wakes them up and keeps them from keeping their legs still.

According to the American Academy of Sleep Medicine, periodic limb movement disorder of sleep is characterized by frequent limb movements that last at least 0.5 seconds and are separated by no more than 90 seconds. “They’re four movements in a row that are at least 5 seconds apart,” Dr. Sheldon said.

Interestingly, he added, children who have limb movement disorder have symptoms during the day, similar to adults. “But we see many children with periodic limb movements of sleep whose arms and legs are moving all night, and they don’t have many symptoms during the day.” These children may have difficulty falling or staying asleep, but do not fulfill all of the American Academy of Sleep Medicine criteria for diagnosis of periodic limb movement disorder, he added.

In 2018, Lourdes M. DelRosso, MD, EdD, of Seattle Children’s Hospital, and colleagues described a new sleep problem they termed restless sleep disorder: those who do not fit the criteria for any other sleep disorder but have daytime impairment.

“On video they have very frequent movements – more than five movements an hour of major body activity,” Dr. Sheldon explained. “They’ll move their trunk, their legs, and reposition themselves. We have found that there are many children who presented to the sleep disorder center with restless sleep, limb movement disorder, periodic limb movements of sleep, and daytime symptoms that would fulfill the criteria of periodic limb movement disorder but also have atopic dermatitis.”

Recently, Dr. Sheldon and his colleagues used polysomnographic variables to study children who presented to Lurie Children’s Hospital with AD and symptoms such as difficulty maintaining sleep and snoring with allergic rhinitis. They found that there were increased periods of being awake after the onset of sleep, “meaning the children fell asleep fairly easily in the beginning of the night but they had significant wake after they fell asleep,” he said. “They would wake up in the middle of the night and stay awake for long periods of time – either one long session or multiple shorter sessions throughout the night. They had increased total limb movements per hour of sleep. This means that their limb movements were greater than five events per hour of sleep and it resulted in restless sleep and limb movements that would fulfill the criteria of periodic limb movement disorder.”

Most of these children had mild to moderate AD, he continued. “We feel that the sensory afferent loop in these youngsters doesn’t really turn off completely when they’re asleep. This is ripe for further study, but it makes intuitive sense that if the sensory afferent loop continues during sleep, it may affect the arousal system significantly.”

Dr. Sheldon recommended that any child who presents with a diagnosis of periodic limb movement disorder, periodic limb movements of sleep, or restless sleep disorder should be evaluated for AD. “The treatment then, would first require differentiation between periodic limb movement disorder of sleep and AD. Both should be addressed at the same time in order to solve the child’s daytime AD problem as well as the sleep-related issues that occur with an AD diagnosis.”

He reported having no financial disclosures.