Cannabis-derived compounds, such as cannabidiol (CBD), are popping up like weeds (so to speak) in retail and online stores, and are being marketed for a wide range of purported health benefits, most of which are unsubstantiated. Cannabidiol—a chemical component of the Cannabis sativa plant (marijuana)—does not produce intoxication or euphoria (ie, the “high”) that comes from delta-9-tetrahydrocannabinol (THC), which is the psychoactive component of marijuana.¹ Cannabidiol has become popular partly due to increased cultural acceptance of marijuana. In a 2019 Pew Research Center survey, 67% of Americans supported marijuana legalization.²

In addition, changing laws have increased the interest in and availability of CBD. The Agricultural Improvement Act of 2018 legalized hemp, which is defined as cannabis and cannabis-derived compounds with significantly low concentrations of THC (<0.3% on a dry weight basis).^1,3 However, this act also preserved the FDA’s authority to regulate products containing cannabis and cannabis-derived compounds.¹

With the recent emphasis on CBD, it is easy to forget that the FDA has approved a few medications that are derived from or related to cannabis. In this article, I review the current FDA-approved cannabis-related treatments and their indications, and concerns regarding CBD products.

FDA-approved treatments

To date, the FDA has not approved cannabis for the treatment of any medical or psychiatric condition. However, the FDA has approved 1 cannabis-derived medication (CBD) and 2 cannabis-related medications (dronabinol and nabilone) for specific indications (these medications are available by prescription only):

Cannabidiol (brand name: Epidiolex) is approved for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients age ≥2, and for the treatment of seizures associated with tuberous sclerosis complex in patients age ≥1.^1,4 There are no other FDA-approved medications that contain CBD.

Dronabinol (brand names: Marinol and Syndros) is an antiemetic agent that contains synthetic THC. It is approved for treating or preventing nausea and vomiting caused by cancer medications and for increasing the appetite of individuals with AIDS.¹

Nabilone (brand name: Cesamet) is a synthetic compound that is structurally similar to THC. It is approved for treating or preventing nausea and vomiting caused by cancer medications.¹

Continue to: Questionable claims about CBD

Some manufacturers market CBD products as having a variety of health benefits for both humans and pets, but most of these claims are unsubstantiated.¹ The FDA has issued warning letters to several manufacturers who have marketed CBD products as producing therapeutic effects.⁵

Under the Federal Food, Drug, and Cosmetic Act, any products intended to have a therapeutic effect are considered drugs, and unapproved drugs cannot be distributed or sold in interstate commerce.¹ Cannabidiol products cannot be sold as dietary supplements.¹ In addition, food products containing CBD cannot be introduced or delivered for introduction into interstate commerce.¹ Many CBD products do not contain the amount of CBD advertised, and some contain contaminants such as pesticides and heavy metals.¹ Also, CBD products can affect the therapeutic effectiveness of prescription medications.

Discuss CBD with your patients

Ask your patients if they use CBD and, if so, find out which product(s), the quantity and frequency of use, and any effects they have experienced from using them. Patients can report any adverse effects from CBD products to the FDA’s MedWatch program (www.accessdata.fda.gov/scripts/medwatch/). Tell your patients that there is limited or inconclusive evidence regarding the therapeutic efficacy of over-the-counter CBD products for any medical or psychiatric condition. Encourage your patients to be open with you about using these products, so you can make appropriate treatment decisions.

Cannabis-derived compounds, such as cannabidiol (CBD), are popping up like weeds (so to speak) in retail and online stores, and are being marketed for a wide range of purported health benefits, most of which are unsubstantiated. Cannabidiol—a chemical component of the Cannabis sativa plant (marijuana)—does not produce intoxication or euphoria (ie, the “high”) that comes from delta-9-tetrahydrocannabinol (THC), which is the psychoactive component of marijuana.¹ Cannabidiol has become popular partly due to increased cultural acceptance of marijuana. In a 2019 Pew Research Center survey, 67% of Americans supported marijuana legalization.²

In addition, changing laws have increased the interest in and availability of CBD. The Agricultural Improvement Act of 2018 legalized hemp, which is defined as cannabis and cannabis-derived compounds with significantly low concentrations of THC (<0.3% on a dry weight basis).^1,3 However, this act also preserved the FDA’s authority to regulate products containing cannabis and cannabis-derived compounds.¹

With the recent emphasis on CBD, it is easy to forget that the FDA has approved a few medications that are derived from or related to cannabis. In this article, I review the current FDA-approved cannabis-related treatments and their indications, and concerns regarding CBD products.

FDA-approved treatments

To date, the FDA has not approved cannabis for the treatment of any medical or psychiatric condition. However, the FDA has approved 1 cannabis-derived medication (CBD) and 2 cannabis-related medications (dronabinol and nabilone) for specific indications (these medications are available by prescription only):

Cannabidiol (brand name: Epidiolex) is approved for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients age ≥2, and for the treatment of seizures associated with tuberous sclerosis complex in patients age ≥1.^1,4 There are no other FDA-approved medications that contain CBD.

Dronabinol (brand names: Marinol and Syndros) is an antiemetic agent that contains synthetic THC. It is approved for treating or preventing nausea and vomiting caused by cancer medications and for increasing the appetite of individuals with AIDS.¹

Nabilone (brand name: Cesamet) is a synthetic compound that is structurally similar to THC. It is approved for treating or preventing nausea and vomiting caused by cancer medications.¹

Continue to: Questionable claims about CBD

Some manufacturers market CBD products as having a variety of health benefits for both humans and pets, but most of these claims are unsubstantiated.¹ The FDA has issued warning letters to several manufacturers who have marketed CBD products as producing therapeutic effects.⁵

Under the Federal Food, Drug, and Cosmetic Act, any products intended to have a therapeutic effect are considered drugs, and unapproved drugs cannot be distributed or sold in interstate commerce.¹ Cannabidiol products cannot be sold as dietary supplements.¹ In addition, food products containing CBD cannot be introduced or delivered for introduction into interstate commerce.¹ Many CBD products do not contain the amount of CBD advertised, and some contain contaminants such as pesticides and heavy metals.¹ Also, CBD products can affect the therapeutic effectiveness of prescription medications.

Discuss CBD with your patients

Ask your patients if they use CBD and, if so, find out which product(s), the quantity and frequency of use, and any effects they have experienced from using them. Patients can report any adverse effects from CBD products to the FDA’s MedWatch program (www.accessdata.fda.gov/scripts/medwatch/). Tell your patients that there is limited or inconclusive evidence regarding the therapeutic efficacy of over-the-counter CBD products for any medical or psychiatric condition. Encourage your patients to be open with you about using these products, so you can make appropriate treatment decisions.

Cannabis-derived compounds, such as cannabidiol (CBD), are popping up like weeds (so to speak) in retail and online stores, and are being marketed for a wide range of purported health benefits, most of which are unsubstantiated. Cannabidiol—a chemical component of the Cannabis sativa plant (marijuana)—does not produce intoxication or euphoria (ie, the “high”) that comes from delta-9-tetrahydrocannabinol (THC), which is the psychoactive component of marijuana.¹ Cannabidiol has become popular partly due to increased cultural acceptance of marijuana. In a 2019 Pew Research Center survey, 67% of Americans supported marijuana legalization.²

In addition, changing laws have increased the interest in and availability of CBD. The Agricultural Improvement Act of 2018 legalized hemp, which is defined as cannabis and cannabis-derived compounds with significantly low concentrations of THC (<0.3% on a dry weight basis).^1,3 However, this act also preserved the FDA’s authority to regulate products containing cannabis and cannabis-derived compounds.¹

With the recent emphasis on CBD, it is easy to forget that the FDA has approved a few medications that are derived from or related to cannabis. In this article, I review the current FDA-approved cannabis-related treatments and their indications, and concerns regarding CBD products.

FDA-approved treatments

To date, the FDA has not approved cannabis for the treatment of any medical or psychiatric condition. However, the FDA has approved 1 cannabis-derived medication (CBD) and 2 cannabis-related medications (dronabinol and nabilone) for specific indications (these medications are available by prescription only):

Cannabidiol (brand name: Epidiolex) is approved for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients age ≥2, and for the treatment of seizures associated with tuberous sclerosis complex in patients age ≥1.^1,4 There are no other FDA-approved medications that contain CBD.

Dronabinol (brand names: Marinol and Syndros) is an antiemetic agent that contains synthetic THC. It is approved for treating or preventing nausea and vomiting caused by cancer medications and for increasing the appetite of individuals with AIDS.¹

Nabilone (brand name: Cesamet) is a synthetic compound that is structurally similar to THC. It is approved for treating or preventing nausea and vomiting caused by cancer medications.¹

Continue to: Questionable claims about CBD

Some manufacturers market CBD products as having a variety of health benefits for both humans and pets, but most of these claims are unsubstantiated.¹ The FDA has issued warning letters to several manufacturers who have marketed CBD products as producing therapeutic effects.⁵

Under the Federal Food, Drug, and Cosmetic Act, any products intended to have a therapeutic effect are considered drugs, and unapproved drugs cannot be distributed or sold in interstate commerce.¹ Cannabidiol products cannot be sold as dietary supplements.¹ In addition, food products containing CBD cannot be introduced or delivered for introduction into interstate commerce.¹ Many CBD products do not contain the amount of CBD advertised, and some contain contaminants such as pesticides and heavy metals.¹ Also, CBD products can affect the therapeutic effectiveness of prescription medications.

Discuss CBD with your patients

Ask your patients if they use CBD and, if so, find out which product(s), the quantity and frequency of use, and any effects they have experienced from using them. Patients can report any adverse effects from CBD products to the FDA’s MedWatch program (www.accessdata.fda.gov/scripts/medwatch/). Tell your patients that there is limited or inconclusive evidence regarding the therapeutic efficacy of over-the-counter CBD products for any medical or psychiatric condition. Encourage your patients to be open with you about using these products, so you can make appropriate treatment decisions.

Tender erythematous nodules or plaques on the extensor surfaces—usually on the legs and occasionally on the arms—are the hallmarks for erythema nodosum, which was diagnosed in this case. It typically occurs in young women, ages 15 to 30, and the nodules or plaques are often accompanied by prodromal fever and malaise. The lesions often are painful and tender to pressure or palpation; they are thought to be caused by a reaction to a stimulus, leading to inflammation of the septa in the subcutaneous fat. While the trigger is often unknown, in some cases, an underlying infection, particularly Streptococcus or tuberculosis (TB), is identified. Sarcoidosis, malignancy, or an increase in estrogen (exogenous or endogenous) also can provoke the disorder.

Due to the risk of underlying disease or triggers, it is prudent to perform radiography of the chest, as well as obtain a complete blood count, sedimentation rate or C reactive protein, and an antistreptolysin O titer when you suspect erythema nodosum. TB testing is also advised. Biopsy typically is not performed because the diagnosis usually is made clinically. If the diagnosis is in doubt, a biopsy can offer confirmation or lead to a different diagnosis such as vasculitis—especially if the lesions are eroded. Since erythema nodosum is an inflammation of the subcutaneous fat, it is important to sample skin lesions deeper than the usual punch biopsy; an incisional biopsy may be required to get an adequate sample.

Erythema nodosum typically resolves spontaneously over a period of weeks, even if there is underlying disease. Therefore, it may be possible to defer treatment if minimal symptoms are present. Otherwise, first-line treatment for the pain and malaise is a nonsteroidal anti-inflammatory drug (NSAID). Oral potassium iodide (360-900 mg/d) is considered second-line treatment and systemic corticosteroids are a third-line option.

For this patient, biopsy was deferred and diagnostic tests were all negative. She had notable pain and a history of good resolution of symptoms with prednisone (5 mg/d), so this drug was prescribed for a 7-day course. She was counseled to avoid taking the NSAIDs and prednisone together due to increased risk of gastritis and ulceration. Recurrent disease can be treated with dapsone (100 mg/d) or hydroxychloroquine (200 mg bid).

‌

Photo and text courtesy of Daniel Stulberg, MD, FAAFP, Department of Family and Community Medicine, University of New Mexico School of Medicine, Albuquerque.

Tender erythematous nodules or plaques on the extensor surfaces—usually on the legs and occasionally on the arms—are the hallmarks for erythema nodosum, which was diagnosed in this case. It typically occurs in young women, ages 15 to 30, and the nodules or plaques are often accompanied by prodromal fever and malaise. The lesions often are painful and tender to pressure or palpation; they are thought to be caused by a reaction to a stimulus, leading to inflammation of the septa in the subcutaneous fat. While the trigger is often unknown, in some cases, an underlying infection, particularly Streptococcus or tuberculosis (TB), is identified. Sarcoidosis, malignancy, or an increase in estrogen (exogenous or endogenous) also can provoke the disorder.

Due to the risk of underlying disease or triggers, it is prudent to perform radiography of the chest, as well as obtain a complete blood count, sedimentation rate or C reactive protein, and an antistreptolysin O titer when you suspect erythema nodosum. TB testing is also advised. Biopsy typically is not performed because the diagnosis usually is made clinically. If the diagnosis is in doubt, a biopsy can offer confirmation or lead to a different diagnosis such as vasculitis—especially if the lesions are eroded. Since erythema nodosum is an inflammation of the subcutaneous fat, it is important to sample skin lesions deeper than the usual punch biopsy; an incisional biopsy may be required to get an adequate sample.

Erythema nodosum typically resolves spontaneously over a period of weeks, even if there is underlying disease. Therefore, it may be possible to defer treatment if minimal symptoms are present. Otherwise, first-line treatment for the pain and malaise is a nonsteroidal anti-inflammatory drug (NSAID). Oral potassium iodide (360-900 mg/d) is considered second-line treatment and systemic corticosteroids are a third-line option.

For this patient, biopsy was deferred and diagnostic tests were all negative. She had notable pain and a history of good resolution of symptoms with prednisone (5 mg/d), so this drug was prescribed for a 7-day course. She was counseled to avoid taking the NSAIDs and prednisone together due to increased risk of gastritis and ulceration. Recurrent disease can be treated with dapsone (100 mg/d) or hydroxychloroquine (200 mg bid).

‌

Photo and text courtesy of Daniel Stulberg, MD, FAAFP, Department of Family and Community Medicine, University of New Mexico School of Medicine, Albuquerque.

Tender erythematous nodules or plaques on the extensor surfaces—usually on the legs and occasionally on the arms—are the hallmarks for erythema nodosum, which was diagnosed in this case. It typically occurs in young women, ages 15 to 30, and the nodules or plaques are often accompanied by prodromal fever and malaise. The lesions often are painful and tender to pressure or palpation; they are thought to be caused by a reaction to a stimulus, leading to inflammation of the septa in the subcutaneous fat. While the trigger is often unknown, in some cases, an underlying infection, particularly Streptococcus or tuberculosis (TB), is identified. Sarcoidosis, malignancy, or an increase in estrogen (exogenous or endogenous) also can provoke the disorder.

Due to the risk of underlying disease or triggers, it is prudent to perform radiography of the chest, as well as obtain a complete blood count, sedimentation rate or C reactive protein, and an antistreptolysin O titer when you suspect erythema nodosum. TB testing is also advised. Biopsy typically is not performed because the diagnosis usually is made clinically. If the diagnosis is in doubt, a biopsy can offer confirmation or lead to a different diagnosis such as vasculitis—especially if the lesions are eroded. Since erythema nodosum is an inflammation of the subcutaneous fat, it is important to sample skin lesions deeper than the usual punch biopsy; an incisional biopsy may be required to get an adequate sample.

Erythema nodosum typically resolves spontaneously over a period of weeks, even if there is underlying disease. Therefore, it may be possible to defer treatment if minimal symptoms are present. Otherwise, first-line treatment for the pain and malaise is a nonsteroidal anti-inflammatory drug (NSAID). Oral potassium iodide (360-900 mg/d) is considered second-line treatment and systemic corticosteroids are a third-line option.

For this patient, biopsy was deferred and diagnostic tests were all negative. She had notable pain and a history of good resolution of symptoms with prednisone (5 mg/d), so this drug was prescribed for a 7-day course. She was counseled to avoid taking the NSAIDs and prednisone together due to increased risk of gastritis and ulceration. Recurrent disease can be treated with dapsone (100 mg/d) or hydroxychloroquine (200 mg bid).

‌

Photo and text courtesy of Daniel Stulberg, MD, FAAFP, Department of Family and Community Medicine, University of New Mexico School of Medicine, Albuquerque.

I write this editorial in mid-September. Fires (and ash) are devastating the West and multiple hurricanes are pummeling the Gulf Coast states. We are struggling to admit how our democracy has systematically failed so many people and learn how we might rectify past inequities and abuses so we can create a better future together. All this with the backdrop of COVID-19, as we pass 200,000 American deaths. We will figure this out and be stronger, but for now it is exhausting, and many people are suffering.

The year 2020 will change gastroenterology forever. The economic fallout already has accelerated the disappearance of traditional medical practices, whose finances were based on steady cash flow. Medicaid rolls will increase from 70 million to over 80 million next year, putting State budgets in deficit and likely altering enrollment requirements. Currently, only half of Baby Boomers are enrolled in Medicare, a statistic that will change with loss of employment and early retirements. Many Americans are losing their employer-based insurance and shifting to government-based insurance (or losing insurance entirely). Providers will face enormous financial headwinds for years no matter how rapidly our economy recovers.

But not all news is bad. We can still read how scientific knowledge continues to progress (our issue this month is rich with examples). Our responses to COVID-19 have been breath-taking in their speed. The death rate per hospitalized patient has fallen dramatically, we continue to learn how to mitigate the effects of COVID-19, and we anticipate a vaccine in record time compared with past epidemics. Physicians and other health care providers are demonstrating daily their dedication to patients despite physical, emotional, and mental exhaustion.

I have no glib answers or words of advice. But I continue to be optimistic. In a nonpartisan tone, I quote Bill Clinton’s 1993 inaugural address: “There is nothing wrong with America that cannot be cured by what is right with America.”
 

John I. Allen, MD, MBA, AGAF
Editor in Chief

I write this editorial in mid-September. Fires (and ash) are devastating the West and multiple hurricanes are pummeling the Gulf Coast states. We are struggling to admit how our democracy has systematically failed so many people and learn how we might rectify past inequities and abuses so we can create a better future together. All this with the backdrop of COVID-19, as we pass 200,000 American deaths. We will figure this out and be stronger, but for now it is exhausting, and many people are suffering.

The year 2020 will change gastroenterology forever. The economic fallout already has accelerated the disappearance of traditional medical practices, whose finances were based on steady cash flow. Medicaid rolls will increase from 70 million to over 80 million next year, putting State budgets in deficit and likely altering enrollment requirements. Currently, only half of Baby Boomers are enrolled in Medicare, a statistic that will change with loss of employment and early retirements. Many Americans are losing their employer-based insurance and shifting to government-based insurance (or losing insurance entirely). Providers will face enormous financial headwinds for years no matter how rapidly our economy recovers.

But not all news is bad. We can still read how scientific knowledge continues to progress (our issue this month is rich with examples). Our responses to COVID-19 have been breath-taking in their speed. The death rate per hospitalized patient has fallen dramatically, we continue to learn how to mitigate the effects of COVID-19, and we anticipate a vaccine in record time compared with past epidemics. Physicians and other health care providers are demonstrating daily their dedication to patients despite physical, emotional, and mental exhaustion.

I have no glib answers or words of advice. But I continue to be optimistic. In a nonpartisan tone, I quote Bill Clinton’s 1993 inaugural address: “There is nothing wrong with America that cannot be cured by what is right with America.”
 

John I. Allen, MD, MBA, AGAF
Editor in Chief

I write this editorial in mid-September. Fires (and ash) are devastating the West and multiple hurricanes are pummeling the Gulf Coast states. We are struggling to admit how our democracy has systematically failed so many people and learn how we might rectify past inequities and abuses so we can create a better future together. All this with the backdrop of COVID-19, as we pass 200,000 American deaths. We will figure this out and be stronger, but for now it is exhausting, and many people are suffering.

The year 2020 will change gastroenterology forever. The economic fallout already has accelerated the disappearance of traditional medical practices, whose finances were based on steady cash flow. Medicaid rolls will increase from 70 million to over 80 million next year, putting State budgets in deficit and likely altering enrollment requirements. Currently, only half of Baby Boomers are enrolled in Medicare, a statistic that will change with loss of employment and early retirements. Many Americans are losing their employer-based insurance and shifting to government-based insurance (or losing insurance entirely). Providers will face enormous financial headwinds for years no matter how rapidly our economy recovers.

But not all news is bad. We can still read how scientific knowledge continues to progress (our issue this month is rich with examples). Our responses to COVID-19 have been breath-taking in their speed. The death rate per hospitalized patient has fallen dramatically, we continue to learn how to mitigate the effects of COVID-19, and we anticipate a vaccine in record time compared with past epidemics. Physicians and other health care providers are demonstrating daily their dedication to patients despite physical, emotional, and mental exhaustion.

I have no glib answers or words of advice. But I continue to be optimistic. In a nonpartisan tone, I quote Bill Clinton’s 1993 inaugural address: “There is nothing wrong with America that cannot be cured by what is right with America.”
 

John I. Allen, MD, MBA, AGAF
Editor in Chief

The diagnosis of acute lymphoblastic leukemia (ALL) can be delayed because of vague presentation and normal hematological results. Orthopedic manifestations may be the primary presentation of ALL to physicians, and such symptoms in children should be cause for suspicion, even in the absence of hematological abnormalities, according to a report published in the Journal of Orthopaedics.

The study retrospectively assessed 250 consecutive ALL patients at a single institution to identify the frequency of ALL cases presented to the orthopedic department and to determine the number of these patients presenting with normal hematological results, according to Amrath Raj BK, MD, and colleagues at the Manipal (India) Academy of Higher Education.
 

Suspicion warranted

Twenty-two of the 250 patients (8.8%) presented primarily to the orthopedic department (4 with vertebral compression fractures, 12 with joint pain, and 6 with bone pain), but were subsequently diagnosed with ALL. These results were comparable to previous studies. The mean patient age at the first visit was 5.6 years; 13 patients were boys, and 9 were girls. Six of these 22 patients (27.3%) had a normal peripheral blood smear, according to the researchers.

“Acute leukemia should be considered strongly as a differential diagnosis in children with severe osteoporosis and vertebral fractures. Initial orthopedic manifestations are not uncommon, and the primary physician should maintain a high index of suspicion as a peripheral smear is not diagnostic in all patients,” the researchers concluded.

The authors reported that there was no outside funding source and that they had no conflicts.

[email protected]

SOURCE: Raj BK A et al. Journal of Orthopaedics. 2020;22:326-330.

The diagnosis of acute lymphoblastic leukemia (ALL) can be delayed because of vague presentation and normal hematological results. Orthopedic manifestations may be the primary presentation of ALL to physicians, and such symptoms in children should be cause for suspicion, even in the absence of hematological abnormalities, according to a report published in the Journal of Orthopaedics.

The study retrospectively assessed 250 consecutive ALL patients at a single institution to identify the frequency of ALL cases presented to the orthopedic department and to determine the number of these patients presenting with normal hematological results, according to Amrath Raj BK, MD, and colleagues at the Manipal (India) Academy of Higher Education.
 

Suspicion warranted

Twenty-two of the 250 patients (8.8%) presented primarily to the orthopedic department (4 with vertebral compression fractures, 12 with joint pain, and 6 with bone pain), but were subsequently diagnosed with ALL. These results were comparable to previous studies. The mean patient age at the first visit was 5.6 years; 13 patients were boys, and 9 were girls. Six of these 22 patients (27.3%) had a normal peripheral blood smear, according to the researchers.

“Acute leukemia should be considered strongly as a differential diagnosis in children with severe osteoporosis and vertebral fractures. Initial orthopedic manifestations are not uncommon, and the primary physician should maintain a high index of suspicion as a peripheral smear is not diagnostic in all patients,” the researchers concluded.

The authors reported that there was no outside funding source and that they had no conflicts.

[email protected]

SOURCE: Raj BK A et al. Journal of Orthopaedics. 2020;22:326-330.

The diagnosis of acute lymphoblastic leukemia (ALL) can be delayed because of vague presentation and normal hematological results. Orthopedic manifestations may be the primary presentation of ALL to physicians, and such symptoms in children should be cause for suspicion, even in the absence of hematological abnormalities, according to a report published in the Journal of Orthopaedics.

The study retrospectively assessed 250 consecutive ALL patients at a single institution to identify the frequency of ALL cases presented to the orthopedic department and to determine the number of these patients presenting with normal hematological results, according to Amrath Raj BK, MD, and colleagues at the Manipal (India) Academy of Higher Education.
 

Suspicion warranted

Twenty-two of the 250 patients (8.8%) presented primarily to the orthopedic department (4 with vertebral compression fractures, 12 with joint pain, and 6 with bone pain), but were subsequently diagnosed with ALL. These results were comparable to previous studies. The mean patient age at the first visit was 5.6 years; 13 patients were boys, and 9 were girls. Six of these 22 patients (27.3%) had a normal peripheral blood smear, according to the researchers.

“Acute leukemia should be considered strongly as a differential diagnosis in children with severe osteoporosis and vertebral fractures. Initial orthopedic manifestations are not uncommon, and the primary physician should maintain a high index of suspicion as a peripheral smear is not diagnostic in all patients,” the researchers concluded.

The authors reported that there was no outside funding source and that they had no conflicts.

[email protected]

SOURCE: Raj BK A et al. Journal of Orthopaedics. 2020;22:326-330.

Good news about cancer – with new data showing falling mortality rates and improved survival rates – is tempered somewhat by a “grim reality,” says the American Association for Cancer Research (AACR).

“The burden of cancer is not shouldered equally by all segments of the U.S. population,” the AACR adds. “The adverse differences in cancer burden that exist among certain population groups are one of the most pressing public health challenges that we face in the United States.” 

AACR president Antoni Ribas, MD, PhD, gave some examples of these disparities at a September 16 Congressional briefing that focused on the inaugural AACR Cancer Disparities Progress Report 2020.

He noted that:

• Black men have more than double the rate of death from prostate cancer compared with men of other racial and ethnic groups.
• Hispanic children are 24% more likely to develop leukemia than non-Hispanic children.
• Non-Hispanic Black children and adolescents with cancer are more than 50% more likely to die from the cancer than non-Hispanic white children and adolescents with cancer.
• Women of low socioeconomic status with early stage ovarian cancer are 50% less likely to receive recommended care than are women of high socioeconomic status.
• In addition to racial and ethnic minority groups, other populations that bear a disproportionate burden when it comes to cancer include individuals lacking adequate health insurance coverage, immigrants, those with disabilities, residents in rural areas, and members of the lesbian, gay, bisexual, and transgender communities.

“It is absolutely unacceptable that advances in cancer care and treatment are not benefiting everyone equally,” Ribas commented.
 

Making progress against cancer

Progress being made against cancer was highlighted in another publication, the annual AACR Cancer Progress Report 2020.

U.S. cancer deaths declined by 29% between 1991 and 2017, translating to nearly 3 million cancer deaths avoided, the report notes. In addition, 5-year survival rates for all cancers combined increased from 49% in the mid-1970s to 70% for patients diagnosed from 2010-2016.

Between August 2019 and July 31 of this year, the U.S. Food and Drug Administration approved 20 new anticancer drugs for various cancer types and 15 new indications for previously approved cancer drugs, marking the highest number of approvals in one 12-month period since AACR started producing these reports 10 years ago.

A continuing reduction in the cigarette smoking rate among US adults, which is now below 14%, is contributing greatly to declines in lung cancer rates, which have largely driven the improvements in cancer survival, the AACR noted.

This report also notes that progress has been made toward reducing cancer disparities. Overall disparities in cancer death rates among racial and ethnic groups are less pronounced now than they have been in the past two decades. For example, the overall cancer death rate for African American patients was 33% higher than for White patients in 1990 but just 14% higher in 2016.

However, both reports agree that more must be done to reduce cancer disparities even further. 

They highlight initiatives that are underway, including:

• The draft guidance issued by the FDA to promote diversification of clinical trial populations.
• The National Institutes of Health’s (NIH’s) Continuing Umbrella of Research Experiences (CURE) program supporting underrepresented students and scientists along their academic and research career pathway.
• The Centers for Disease Control and Prevention’s Racial and Ethnic Approaches to Community Health (REACH) program, a grant-making program focused on encouraging preventive behaviors in underserved communities.
• The NIH’s All of Us program, which is gathering information from the genomes of 1 million healthy individuals with a focus on recruitment from historically underrepresented populations.

Ribas also announced that AACR has established a task force to focus on racial inequalities in cancer research.

Eliminating disparities would save money, argued John D. Carpten, PhD, from the University of Southern California, Los Angeles, who chaired the steering committee that developed the AACR Cancer Disparities Progress Report.

Carpten noted research showing that eliminating disparities for racial and ethnic minorities between 2003 and 2006 would have reduced health care costs by more than $1 trillion in the United States. This underscores the potentially far-reaching impact of efforts to eliminate disparities, he said.

“Without a doubt, socioeconomics and inequities in access to quality care represent major factors influencing cancer health disparities, and these disparities will persist until we address these issues” he said.

Both progress reports culminate in a call to action, largely focused on the need for “unwavering, bipartisan support from Congress, in the form of robust and sustained annual increases in funding for the NIH, NCI [National Cancer Institute], and FDA,” which is vital for accelerating the pace of progress.

The challenge is now compounded by the ongoing COVID-19 pandemic: Both progress reports note that racial and ethnic minorities, including African Americans, are not only affected disproportionately by cancer, but also by COVID-19, further highlighting the “stark inequities in health care.”

Ribas further called for action from national leadership and the scientific community.

“During this unprecedented time in our nation’s history, there is also a need for our nation’s leaders to take on a much bigger role in confronting and combating the structural and systemic racism that contributes to health disparities,” he said. The “pervasive racism and social injustices” that have contributed to disparities in both COVID-19 and cancer underscore the need for “the scientific community to step up and partner with Congress to assess and address this issue within the research community.”

This article first appeared on Medscape.com.

Good news about cancer – with new data showing falling mortality rates and improved survival rates – is tempered somewhat by a “grim reality,” says the American Association for Cancer Research (AACR).

“The burden of cancer is not shouldered equally by all segments of the U.S. population,” the AACR adds. “The adverse differences in cancer burden that exist among certain population groups are one of the most pressing public health challenges that we face in the United States.” 

AACR president Antoni Ribas, MD, PhD, gave some examples of these disparities at a September 16 Congressional briefing that focused on the inaugural AACR Cancer Disparities Progress Report 2020.

He noted that:

• Black men have more than double the rate of death from prostate cancer compared with men of other racial and ethnic groups.
• Hispanic children are 24% more likely to develop leukemia than non-Hispanic children.
• Non-Hispanic Black children and adolescents with cancer are more than 50% more likely to die from the cancer than non-Hispanic white children and adolescents with cancer.
• Women of low socioeconomic status with early stage ovarian cancer are 50% less likely to receive recommended care than are women of high socioeconomic status.
• In addition to racial and ethnic minority groups, other populations that bear a disproportionate burden when it comes to cancer include individuals lacking adequate health insurance coverage, immigrants, those with disabilities, residents in rural areas, and members of the lesbian, gay, bisexual, and transgender communities.

“It is absolutely unacceptable that advances in cancer care and treatment are not benefiting everyone equally,” Ribas commented.
 

Making progress against cancer

Progress being made against cancer was highlighted in another publication, the annual AACR Cancer Progress Report 2020.

U.S. cancer deaths declined by 29% between 1991 and 2017, translating to nearly 3 million cancer deaths avoided, the report notes. In addition, 5-year survival rates for all cancers combined increased from 49% in the mid-1970s to 70% for patients diagnosed from 2010-2016.

Between August 2019 and July 31 of this year, the U.S. Food and Drug Administration approved 20 new anticancer drugs for various cancer types and 15 new indications for previously approved cancer drugs, marking the highest number of approvals in one 12-month period since AACR started producing these reports 10 years ago.

A continuing reduction in the cigarette smoking rate among US adults, which is now below 14%, is contributing greatly to declines in lung cancer rates, which have largely driven the improvements in cancer survival, the AACR noted.

This report also notes that progress has been made toward reducing cancer disparities. Overall disparities in cancer death rates among racial and ethnic groups are less pronounced now than they have been in the past two decades. For example, the overall cancer death rate for African American patients was 33% higher than for White patients in 1990 but just 14% higher in 2016.

However, both reports agree that more must be done to reduce cancer disparities even further. 

They highlight initiatives that are underway, including:

• The draft guidance issued by the FDA to promote diversification of clinical trial populations.
• The National Institutes of Health’s (NIH’s) Continuing Umbrella of Research Experiences (CURE) program supporting underrepresented students and scientists along their academic and research career pathway.
• The Centers for Disease Control and Prevention’s Racial and Ethnic Approaches to Community Health (REACH) program, a grant-making program focused on encouraging preventive behaviors in underserved communities.
• The NIH’s All of Us program, which is gathering information from the genomes of 1 million healthy individuals with a focus on recruitment from historically underrepresented populations.

Ribas also announced that AACR has established a task force to focus on racial inequalities in cancer research.

Eliminating disparities would save money, argued John D. Carpten, PhD, from the University of Southern California, Los Angeles, who chaired the steering committee that developed the AACR Cancer Disparities Progress Report.

Carpten noted research showing that eliminating disparities for racial and ethnic minorities between 2003 and 2006 would have reduced health care costs by more than $1 trillion in the United States. This underscores the potentially far-reaching impact of efforts to eliminate disparities, he said.

“Without a doubt, socioeconomics and inequities in access to quality care represent major factors influencing cancer health disparities, and these disparities will persist until we address these issues” he said.

Both progress reports culminate in a call to action, largely focused on the need for “unwavering, bipartisan support from Congress, in the form of robust and sustained annual increases in funding for the NIH, NCI [National Cancer Institute], and FDA,” which is vital for accelerating the pace of progress.

The challenge is now compounded by the ongoing COVID-19 pandemic: Both progress reports note that racial and ethnic minorities, including African Americans, are not only affected disproportionately by cancer, but also by COVID-19, further highlighting the “stark inequities in health care.”

Ribas further called for action from national leadership and the scientific community.

“During this unprecedented time in our nation’s history, there is also a need for our nation’s leaders to take on a much bigger role in confronting and combating the structural and systemic racism that contributes to health disparities,” he said. The “pervasive racism and social injustices” that have contributed to disparities in both COVID-19 and cancer underscore the need for “the scientific community to step up and partner with Congress to assess and address this issue within the research community.”

This article first appeared on Medscape.com.

Good news about cancer – with new data showing falling mortality rates and improved survival rates – is tempered somewhat by a “grim reality,” says the American Association for Cancer Research (AACR).

“The burden of cancer is not shouldered equally by all segments of the U.S. population,” the AACR adds. “The adverse differences in cancer burden that exist among certain population groups are one of the most pressing public health challenges that we face in the United States.” 

AACR president Antoni Ribas, MD, PhD, gave some examples of these disparities at a September 16 Congressional briefing that focused on the inaugural AACR Cancer Disparities Progress Report 2020.

He noted that:

• Black men have more than double the rate of death from prostate cancer compared with men of other racial and ethnic groups.
• Hispanic children are 24% more likely to develop leukemia than non-Hispanic children.
• Non-Hispanic Black children and adolescents with cancer are more than 50% more likely to die from the cancer than non-Hispanic white children and adolescents with cancer.
• Women of low socioeconomic status with early stage ovarian cancer are 50% less likely to receive recommended care than are women of high socioeconomic status.
• In addition to racial and ethnic minority groups, other populations that bear a disproportionate burden when it comes to cancer include individuals lacking adequate health insurance coverage, immigrants, those with disabilities, residents in rural areas, and members of the lesbian, gay, bisexual, and transgender communities.

“It is absolutely unacceptable that advances in cancer care and treatment are not benefiting everyone equally,” Ribas commented.
 

Making progress against cancer

Progress being made against cancer was highlighted in another publication, the annual AACR Cancer Progress Report 2020.

U.S. cancer deaths declined by 29% between 1991 and 2017, translating to nearly 3 million cancer deaths avoided, the report notes. In addition, 5-year survival rates for all cancers combined increased from 49% in the mid-1970s to 70% for patients diagnosed from 2010-2016.

Between August 2019 and July 31 of this year, the U.S. Food and Drug Administration approved 20 new anticancer drugs for various cancer types and 15 new indications for previously approved cancer drugs, marking the highest number of approvals in one 12-month period since AACR started producing these reports 10 years ago.

A continuing reduction in the cigarette smoking rate among US adults, which is now below 14%, is contributing greatly to declines in lung cancer rates, which have largely driven the improvements in cancer survival, the AACR noted.

This report also notes that progress has been made toward reducing cancer disparities. Overall disparities in cancer death rates among racial and ethnic groups are less pronounced now than they have been in the past two decades. For example, the overall cancer death rate for African American patients was 33% higher than for White patients in 1990 but just 14% higher in 2016.

However, both reports agree that more must be done to reduce cancer disparities even further. 

They highlight initiatives that are underway, including:

• The draft guidance issued by the FDA to promote diversification of clinical trial populations.
• The National Institutes of Health’s (NIH’s) Continuing Umbrella of Research Experiences (CURE) program supporting underrepresented students and scientists along their academic and research career pathway.
• The Centers for Disease Control and Prevention’s Racial and Ethnic Approaches to Community Health (REACH) program, a grant-making program focused on encouraging preventive behaviors in underserved communities.
• The NIH’s All of Us program, which is gathering information from the genomes of 1 million healthy individuals with a focus on recruitment from historically underrepresented populations.

Ribas also announced that AACR has established a task force to focus on racial inequalities in cancer research.

Eliminating disparities would save money, argued John D. Carpten, PhD, from the University of Southern California, Los Angeles, who chaired the steering committee that developed the AACR Cancer Disparities Progress Report.

Carpten noted research showing that eliminating disparities for racial and ethnic minorities between 2003 and 2006 would have reduced health care costs by more than $1 trillion in the United States. This underscores the potentially far-reaching impact of efforts to eliminate disparities, he said.

“Without a doubt, socioeconomics and inequities in access to quality care represent major factors influencing cancer health disparities, and these disparities will persist until we address these issues” he said.

Both progress reports culminate in a call to action, largely focused on the need for “unwavering, bipartisan support from Congress, in the form of robust and sustained annual increases in funding for the NIH, NCI [National Cancer Institute], and FDA,” which is vital for accelerating the pace of progress.

The challenge is now compounded by the ongoing COVID-19 pandemic: Both progress reports note that racial and ethnic minorities, including African Americans, are not only affected disproportionately by cancer, but also by COVID-19, further highlighting the “stark inequities in health care.”

Ribas further called for action from national leadership and the scientific community.

“During this unprecedented time in our nation’s history, there is also a need for our nation’s leaders to take on a much bigger role in confronting and combating the structural and systemic racism that contributes to health disparities,” he said. The “pervasive racism and social injustices” that have contributed to disparities in both COVID-19 and cancer underscore the need for “the scientific community to step up and partner with Congress to assess and address this issue within the research community.”

This article first appeared on Medscape.com.

Over-the-counter (OTC) supplements advertised to improve memory and cognitive function may contain unapproved pharmaceutical drugs in potentially dangerous combinations and dosages, new research shows.

“Americans spend more than $600 million on over-the-counter smart pills every year, but we know very little about what is actually in these products,” said Pieter A. Cohen, MD, of the department of medicine at Harvard Medical School, Boston.

“Finding new combinations of drugs [that have] never been tested in humans in over-the-counter brain-boosting supplements is alarming,” said Dr. Cohen.

The study was published online Sept. 23 in Neurology Clinical Practice, a journal of the American Academy of Neurology.
 

Buyer beware

In a search of the National Institutes of Health Dietary Supplement Label Database and the Natural Medicines Database, Dr. Cohen and colleagues identified 10 supplements labeled as containing omberacetam, aniracetam, phenylpiracetam, or oxiracetam – four analogues of piracetam that are not approved for human use in the United States. Piracetam is also not approved in the United States.

In these 10 products, five unapproved drugs were discovered – omberacetam and aniracetam along with three others (phenibut, vinpocetine and picamilon).

By consuming the recommended serving size of these products, consumers could be exposed to pharmaceutical-level dosages of drugs including a maximum of 40.6 mg omberacetam (typical pharmacologic dose 10 mg), 502 mg of aniracetam (typical pharmacologic dose 200-750 mg), 15.4 mg of phenibut (typical dose 250-500 mg), 4.3 mg of vinpocetine (typical dose 5-40 mg), and 90.1 mg of picamilon (typical  dose 50-200 mg), the study team reported.

Several drugs detected in these “smart” pills were not declared on the label, and several declared drugs were not detected in the products. For those products with drug quantities provided on the labels, three-quarters of declared quantities were inaccurate.

Consumers who use these cognitive enhancers could be exposed to amounts of these unapproved drugs that are fourfold greater than pharmaceutical dosages and combinations never tested in humans, the study team says. One product combined three different unapproved drugs and another product contained four different drugs.

“We have previously shown that these products may contain individual foreign drugs, but in our new study we found complex combinations of foreign drugs, up to four different drugs in a single product,” Dr. Cohen said.

The presence of these unapproved drugs in supplements, including at supratherapeutic dosages, suggests “serious risks to consumers and weaknesses in the regulatory framework under which supplements are permitted to be introduced in the U.S.,” Dr. Cohen and colleagues wrote.

“We should counsel our patients to avoid over-the-counter ‘smart pills’ until we can be assured as to the safety and efficacy of these products,” said Dr. Cohen.
 

Concerning findings

Glen R. Finney, MD, director of the Geisinger Memory and Cognition Program at the Neuroscience Institute, Geisinger Health System, Wilkes-Barre, Penn., said in an interview that two findings are very concerning: the lack of listed ingredients and especially the presence of unlisted drugs at active levels. “What if a person has a sensitivity or allergy to one of the unlisted drugs? This is a safety issue and a consumer issue,” Dr. Finney said.

Despite being widely promoted on television, “over-the-counter supplements are not regulated, so there is no guarantee that they contain what they claim, and there is very little evidence that they help memory and thinking even when they do have the ingredients they claim in the supplement,” said Dr. Finney,

“The best way to stay safe and help memory and thinking is to speak with your health providers about proven treatments that have good safety regulation, so you know what you’re getting, and what you’re getting from it,” Dr. Finney advised.

The study had no targeted funding. Dr. Cohen has collaborated in research with NSF International, received compensation from UptoDate, and received research support from Consumers Union and PEW Charitable Trusts. Dr. Finney has no relevant disclosures.

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

Over-the-counter (OTC) supplements advertised to improve memory and cognitive function may contain unapproved pharmaceutical drugs in potentially dangerous combinations and dosages, new research shows.

“Americans spend more than $600 million on over-the-counter smart pills every year, but we know very little about what is actually in these products,” said Pieter A. Cohen, MD, of the department of medicine at Harvard Medical School, Boston.

“Finding new combinations of drugs [that have] never been tested in humans in over-the-counter brain-boosting supplements is alarming,” said Dr. Cohen.

The study was published online Sept. 23 in Neurology Clinical Practice, a journal of the American Academy of Neurology.
 

Buyer beware

In a search of the National Institutes of Health Dietary Supplement Label Database and the Natural Medicines Database, Dr. Cohen and colleagues identified 10 supplements labeled as containing omberacetam, aniracetam, phenylpiracetam, or oxiracetam – four analogues of piracetam that are not approved for human use in the United States. Piracetam is also not approved in the United States.

In these 10 products, five unapproved drugs were discovered – omberacetam and aniracetam along with three others (phenibut, vinpocetine and picamilon).

By consuming the recommended serving size of these products, consumers could be exposed to pharmaceutical-level dosages of drugs including a maximum of 40.6 mg omberacetam (typical pharmacologic dose 10 mg), 502 mg of aniracetam (typical pharmacologic dose 200-750 mg), 15.4 mg of phenibut (typical dose 250-500 mg), 4.3 mg of vinpocetine (typical dose 5-40 mg), and 90.1 mg of picamilon (typical  dose 50-200 mg), the study team reported.

Several drugs detected in these “smart” pills were not declared on the label, and several declared drugs were not detected in the products. For those products with drug quantities provided on the labels, three-quarters of declared quantities were inaccurate.

Consumers who use these cognitive enhancers could be exposed to amounts of these unapproved drugs that are fourfold greater than pharmaceutical dosages and combinations never tested in humans, the study team says. One product combined three different unapproved drugs and another product contained four different drugs.

“We have previously shown that these products may contain individual foreign drugs, but in our new study we found complex combinations of foreign drugs, up to four different drugs in a single product,” Dr. Cohen said.

The presence of these unapproved drugs in supplements, including at supratherapeutic dosages, suggests “serious risks to consumers and weaknesses in the regulatory framework under which supplements are permitted to be introduced in the U.S.,” Dr. Cohen and colleagues wrote.

“We should counsel our patients to avoid over-the-counter ‘smart pills’ until we can be assured as to the safety and efficacy of these products,” said Dr. Cohen.
 

Concerning findings

Glen R. Finney, MD, director of the Geisinger Memory and Cognition Program at the Neuroscience Institute, Geisinger Health System, Wilkes-Barre, Penn., said in an interview that two findings are very concerning: the lack of listed ingredients and especially the presence of unlisted drugs at active levels. “What if a person has a sensitivity or allergy to one of the unlisted drugs? This is a safety issue and a consumer issue,” Dr. Finney said.

Despite being widely promoted on television, “over-the-counter supplements are not regulated, so there is no guarantee that they contain what they claim, and there is very little evidence that they help memory and thinking even when they do have the ingredients they claim in the supplement,” said Dr. Finney,

“The best way to stay safe and help memory and thinking is to speak with your health providers about proven treatments that have good safety regulation, so you know what you’re getting, and what you’re getting from it,” Dr. Finney advised.

The study had no targeted funding. Dr. Cohen has collaborated in research with NSF International, received compensation from UptoDate, and received research support from Consumers Union and PEW Charitable Trusts. Dr. Finney has no relevant disclosures.

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

Over-the-counter (OTC) supplements advertised to improve memory and cognitive function may contain unapproved pharmaceutical drugs in potentially dangerous combinations and dosages, new research shows.

“Americans spend more than $600 million on over-the-counter smart pills every year, but we know very little about what is actually in these products,” said Pieter A. Cohen, MD, of the department of medicine at Harvard Medical School, Boston.

“Finding new combinations of drugs [that have] never been tested in humans in over-the-counter brain-boosting supplements is alarming,” said Dr. Cohen.

The study was published online Sept. 23 in Neurology Clinical Practice, a journal of the American Academy of Neurology.
 

Buyer beware

In a search of the National Institutes of Health Dietary Supplement Label Database and the Natural Medicines Database, Dr. Cohen and colleagues identified 10 supplements labeled as containing omberacetam, aniracetam, phenylpiracetam, or oxiracetam – four analogues of piracetam that are not approved for human use in the United States. Piracetam is also not approved in the United States.

In these 10 products, five unapproved drugs were discovered – omberacetam and aniracetam along with three others (phenibut, vinpocetine and picamilon).

By consuming the recommended serving size of these products, consumers could be exposed to pharmaceutical-level dosages of drugs including a maximum of 40.6 mg omberacetam (typical pharmacologic dose 10 mg), 502 mg of aniracetam (typical pharmacologic dose 200-750 mg), 15.4 mg of phenibut (typical dose 250-500 mg), 4.3 mg of vinpocetine (typical dose 5-40 mg), and 90.1 mg of picamilon (typical  dose 50-200 mg), the study team reported.

Several drugs detected in these “smart” pills were not declared on the label, and several declared drugs were not detected in the products. For those products with drug quantities provided on the labels, three-quarters of declared quantities were inaccurate.

Consumers who use these cognitive enhancers could be exposed to amounts of these unapproved drugs that are fourfold greater than pharmaceutical dosages and combinations never tested in humans, the study team says. One product combined three different unapproved drugs and another product contained four different drugs.

“We have previously shown that these products may contain individual foreign drugs, but in our new study we found complex combinations of foreign drugs, up to four different drugs in a single product,” Dr. Cohen said.

The presence of these unapproved drugs in supplements, including at supratherapeutic dosages, suggests “serious risks to consumers and weaknesses in the regulatory framework under which supplements are permitted to be introduced in the U.S.,” Dr. Cohen and colleagues wrote.

“We should counsel our patients to avoid over-the-counter ‘smart pills’ until we can be assured as to the safety and efficacy of these products,” said Dr. Cohen.
 

Concerning findings

Glen R. Finney, MD, director of the Geisinger Memory and Cognition Program at the Neuroscience Institute, Geisinger Health System, Wilkes-Barre, Penn., said in an interview that two findings are very concerning: the lack of listed ingredients and especially the presence of unlisted drugs at active levels. “What if a person has a sensitivity or allergy to one of the unlisted drugs? This is a safety issue and a consumer issue,” Dr. Finney said.

Despite being widely promoted on television, “over-the-counter supplements are not regulated, so there is no guarantee that they contain what they claim, and there is very little evidence that they help memory and thinking even when they do have the ingredients they claim in the supplement,” said Dr. Finney,

“The best way to stay safe and help memory and thinking is to speak with your health providers about proven treatments that have good safety regulation, so you know what you’re getting, and what you’re getting from it,” Dr. Finney advised.

The study had no targeted funding. Dr. Cohen has collaborated in research with NSF International, received compensation from UptoDate, and received research support from Consumers Union and PEW Charitable Trusts. Dr. Finney has no relevant disclosures.

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

Objective neuropsychological tests can be used to subclassify the cognitive symptoms present in patients with major depression into three patterns having implications for treatment responsiveness, Gitte Moos Knudsen, MD, reported at the virtual congress of the European College of Neuropsychopharmacology.

“Our data highlight the importance of assessing and targeting cognitive symptoms,” said Dr. Knudsen, the ECNP president and professor of neurology at the University of Copenhagen.

She was a coauthor of the Danish NeuroPharm study, in which 92 antidepressant-free patients with moderate or severe major depressive disorder and 103 healthy controls completed a comprehensive neuropsychological test battery. The testing included a validation study of the EMOTICOM test battery, a novel neuropsychological test battery developed specifically to assess what has been called “hot” cognition, such as emotion processing, social cognition, and affective verbal memory.

Overall, the depressed patients collectively showed moderate increases in measures of guilt and shame, moderate deficits in working and verbal memory, moderately slowed reaction time, and mild to moderate negative affective bias, compared with controls. No correlation was found between performance on any of the individual cognitive domains and depression severity as measured using the Hamilton Depression Rating Scale, underscoring the concept that cognitive impairment is a distinct component of depressive pathology rather than an extension of the classic mood and somatic symptoms of major depression.

Cluster analysis revealed three distinct patterns of cognitive impairment in the study population. Unlike the individual cognitive domains, these cognitive clusters did correlate with depression severity. The implication is that neuropsychological testing may identify large subgroups of patients with major depression who may benefit from augmentation of antidepressant medication with treatments targeting impaired cognition, as they become available.

Investigators classified 38 of the 92 patients with major depressive disorder as falling within Cluster A. That is, they exhibited marked deficits in hot cognition expressed in a greatly impaired ability to accurately identify facial emotions on photographs, with resultant high scores for emotion recognition bias and emotion misattribution bias. This impairment in hot cognition was accompanied by minimal guilt and shame and little or no deficits in the cold cognitive domains of verbal and working memory.

Cluster B, composed of 28 patients, was characterized by generally good cognitive function, with positive biases in emotion processing, near-normal guilt and shame ratings, but moderate deficits across the cold cognition domains, making for a mirror image of Cluster A.

The 26 patients in Cluster C demonstrated large deficits in both the hot and cold cognition domains, with particularly pronounced guilt and shame scores.

The three clusters didn’t differ in terms of age or sex. However, patients in Cluster C had significantly more severe core depressive symptoms as measured by Hamilton scores than in Clusters A and B.

This analysis from the NeuroPharm study was cross-sectional. Dr. Knudsen cited a recent large Chinese longitudinal study to underscore how the prevalence of patient-reported cognitive deficits in major depressive disorder is high. And while those deficits decrease over time, they nonetheless remain substantial after 6 months on antidepressant therapy.

That study included 598 Chinese outpatients with major depressive disorder. At baseline, 77% had cognitive symptoms as evidenced by a total score of 21 or more on the self-rated Perceived Deficits Questionnaire–Depression (PDQ-D). One month after going on antidepressant monotherapy, the prevalence of cognitive symptoms had dropped to 59%. At 2 months, the rate was 45%. And at month 6, a PDQ-D score of 21 or greater was still present in 32.4% of patients. High baseline PDQ-D scores were associated with worse clinical outcomes, including a lower treatment response rate at 1 month and a lower remission rate at 2 months. Moreover, high PDQ-D scores at 2 months were associated with lower remission and higher relapse rates at 6 months.

Dr. Knudsen reported having no financial conflicts regarding the NeuroPharm study, which was conducted free of commercial support. She serves as an adviser to Sage Therapeutics and Sanos.

[email protected]

Objective neuropsychological tests can be used to subclassify the cognitive symptoms present in patients with major depression into three patterns having implications for treatment responsiveness, Gitte Moos Knudsen, MD, reported at the virtual congress of the European College of Neuropsychopharmacology.

“Our data highlight the importance of assessing and targeting cognitive symptoms,” said Dr. Knudsen, the ECNP president and professor of neurology at the University of Copenhagen.

She was a coauthor of the Danish NeuroPharm study, in which 92 antidepressant-free patients with moderate or severe major depressive disorder and 103 healthy controls completed a comprehensive neuropsychological test battery. The testing included a validation study of the EMOTICOM test battery, a novel neuropsychological test battery developed specifically to assess what has been called “hot” cognition, such as emotion processing, social cognition, and affective verbal memory.

Overall, the depressed patients collectively showed moderate increases in measures of guilt and shame, moderate deficits in working and verbal memory, moderately slowed reaction time, and mild to moderate negative affective bias, compared with controls. No correlation was found between performance on any of the individual cognitive domains and depression severity as measured using the Hamilton Depression Rating Scale, underscoring the concept that cognitive impairment is a distinct component of depressive pathology rather than an extension of the classic mood and somatic symptoms of major depression.

Cluster analysis revealed three distinct patterns of cognitive impairment in the study population. Unlike the individual cognitive domains, these cognitive clusters did correlate with depression severity. The implication is that neuropsychological testing may identify large subgroups of patients with major depression who may benefit from augmentation of antidepressant medication with treatments targeting impaired cognition, as they become available.

Investigators classified 38 of the 92 patients with major depressive disorder as falling within Cluster A. That is, they exhibited marked deficits in hot cognition expressed in a greatly impaired ability to accurately identify facial emotions on photographs, with resultant high scores for emotion recognition bias and emotion misattribution bias. This impairment in hot cognition was accompanied by minimal guilt and shame and little or no deficits in the cold cognitive domains of verbal and working memory.

Cluster B, composed of 28 patients, was characterized by generally good cognitive function, with positive biases in emotion processing, near-normal guilt and shame ratings, but moderate deficits across the cold cognition domains, making for a mirror image of Cluster A.

The 26 patients in Cluster C demonstrated large deficits in both the hot and cold cognition domains, with particularly pronounced guilt and shame scores.

The three clusters didn’t differ in terms of age or sex. However, patients in Cluster C had significantly more severe core depressive symptoms as measured by Hamilton scores than in Clusters A and B.

This analysis from the NeuroPharm study was cross-sectional. Dr. Knudsen cited a recent large Chinese longitudinal study to underscore how the prevalence of patient-reported cognitive deficits in major depressive disorder is high. And while those deficits decrease over time, they nonetheless remain substantial after 6 months on antidepressant therapy.

That study included 598 Chinese outpatients with major depressive disorder. At baseline, 77% had cognitive symptoms as evidenced by a total score of 21 or more on the self-rated Perceived Deficits Questionnaire–Depression (PDQ-D). One month after going on antidepressant monotherapy, the prevalence of cognitive symptoms had dropped to 59%. At 2 months, the rate was 45%. And at month 6, a PDQ-D score of 21 or greater was still present in 32.4% of patients. High baseline PDQ-D scores were associated with worse clinical outcomes, including a lower treatment response rate at 1 month and a lower remission rate at 2 months. Moreover, high PDQ-D scores at 2 months were associated with lower remission and higher relapse rates at 6 months.

Dr. Knudsen reported having no financial conflicts regarding the NeuroPharm study, which was conducted free of commercial support. She serves as an adviser to Sage Therapeutics and Sanos.

[email protected]

Objective neuropsychological tests can be used to subclassify the cognitive symptoms present in patients with major depression into three patterns having implications for treatment responsiveness, Gitte Moos Knudsen, MD, reported at the virtual congress of the European College of Neuropsychopharmacology.

“Our data highlight the importance of assessing and targeting cognitive symptoms,” said Dr. Knudsen, the ECNP president and professor of neurology at the University of Copenhagen.

She was a coauthor of the Danish NeuroPharm study, in which 92 antidepressant-free patients with moderate or severe major depressive disorder and 103 healthy controls completed a comprehensive neuropsychological test battery. The testing included a validation study of the EMOTICOM test battery, a novel neuropsychological test battery developed specifically to assess what has been called “hot” cognition, such as emotion processing, social cognition, and affective verbal memory.

Overall, the depressed patients collectively showed moderate increases in measures of guilt and shame, moderate deficits in working and verbal memory, moderately slowed reaction time, and mild to moderate negative affective bias, compared with controls. No correlation was found between performance on any of the individual cognitive domains and depression severity as measured using the Hamilton Depression Rating Scale, underscoring the concept that cognitive impairment is a distinct component of depressive pathology rather than an extension of the classic mood and somatic symptoms of major depression.

Cluster analysis revealed three distinct patterns of cognitive impairment in the study population. Unlike the individual cognitive domains, these cognitive clusters did correlate with depression severity. The implication is that neuropsychological testing may identify large subgroups of patients with major depression who may benefit from augmentation of antidepressant medication with treatments targeting impaired cognition, as they become available.

Investigators classified 38 of the 92 patients with major depressive disorder as falling within Cluster A. That is, they exhibited marked deficits in hot cognition expressed in a greatly impaired ability to accurately identify facial emotions on photographs, with resultant high scores for emotion recognition bias and emotion misattribution bias. This impairment in hot cognition was accompanied by minimal guilt and shame and little or no deficits in the cold cognitive domains of verbal and working memory.

Cluster B, composed of 28 patients, was characterized by generally good cognitive function, with positive biases in emotion processing, near-normal guilt and shame ratings, but moderate deficits across the cold cognition domains, making for a mirror image of Cluster A.

The 26 patients in Cluster C demonstrated large deficits in both the hot and cold cognition domains, with particularly pronounced guilt and shame scores.

The three clusters didn’t differ in terms of age or sex. However, patients in Cluster C had significantly more severe core depressive symptoms as measured by Hamilton scores than in Clusters A and B.

This analysis from the NeuroPharm study was cross-sectional. Dr. Knudsen cited a recent large Chinese longitudinal study to underscore how the prevalence of patient-reported cognitive deficits in major depressive disorder is high. And while those deficits decrease over time, they nonetheless remain substantial after 6 months on antidepressant therapy.

That study included 598 Chinese outpatients with major depressive disorder. At baseline, 77% had cognitive symptoms as evidenced by a total score of 21 or more on the self-rated Perceived Deficits Questionnaire–Depression (PDQ-D). One month after going on antidepressant monotherapy, the prevalence of cognitive symptoms had dropped to 59%. At 2 months, the rate was 45%. And at month 6, a PDQ-D score of 21 or greater was still present in 32.4% of patients. High baseline PDQ-D scores were associated with worse clinical outcomes, including a lower treatment response rate at 1 month and a lower remission rate at 2 months. Moreover, high PDQ-D scores at 2 months were associated with lower remission and higher relapse rates at 6 months.

Dr. Knudsen reported having no financial conflicts regarding the NeuroPharm study, which was conducted free of commercial support. She serves as an adviser to Sage Therapeutics and Sanos.

[email protected]

Payment cuts to nearly all of medicine, including gastroenterology, could be in store beginning Jan. 1, 2021. Physicians may also face elimination of some services the Centers for Medicare & Medicaid Services granted temporary access to during the coronavirus (COVID-19) pandemic according to CMS’s recently released policy and payment recommendations. These proposals could be implemented as physician practices are still recovering financially from states’ temporary ban on elective surgeries from March through May 2020 in response to the public health emergency (PHE) and continuing to deal with the clinical and financial challenges of the pandemic.

In early August, CMS proposed a number of changes for 2021 that affect physicians. There’s plenty of good, bad, and ugly in this proposed rule.
 

Let’s start with two positives (The good):

Medicare proposes to maintain the current values for colonoscopy with biopsy (45385) and esophagogastroduodenoscopy (EGD) with biopsy (43239). Despite a recent reevaluation of these codes in 2016 and 2014, respectively, Medicare conceded to Anthem’s suggestion that the procedures were not overvalued and needed another evaluation. The AGA and our sister societies’ data affirmed the current values and Medicare proposed to maintain them in 2021.

Medicare proposes to increase the price for scope video system equipment (ES031) from $36,306 to $70,673.38 and the suction machine (Gomco) (EQ235) from $1,981.66 to $3,195.85, phased in over 2 years. This will provide a small increase in the practice expense value for all GI endoscopy procedures. Since CMS began conducting a review of scope systems in 2017, the AGA and our sister societies have successfully worked to convince the Agency to increase its payment for GI endoscopes and associated equipment by providing invoices. We are pleased Medicare is updating these items to reflect more accurate costs.

Now onto items that could negatively affect the practice of gastroenterology.
 

The bad

Medicare proposes to stop covering and paying for telephone evaluation and management (E/M) visits as soon as the COVID-19 PHE expires. After originally denying that Medicare beneficiaries had trouble accessing video E/M visits and refusing to cover existing telephone (audio only) E/M codes 99441-99443, the agency responded to enormous pressure from AGA and other specialties and added the codes to its covered telehealth services list, setting the payment equal to office/outpatient established patient E/M codes 99212-99214 during the PHE. Telephone E/M has been a vital lifeline, allowing Medicare beneficiaries who don’t have a smart phone or reliable internet connection to access needed E/M services, while allowing them to stay safe at home during the PHE. There is evidence that our most vulnerable patients have the greatest need for telephone visits to advance their care.¹

Medicare’s proposal to stop covering and paying for telephone E/M visits as soon as the COVID-19 PHE expires, while disappointing, is not surprising because of the agency’s reluctance to admit they were needed in the first place. The agency believes that creating a new code for audio-only patient interactions similar to the virtual check-in code G2012 but for a longer unit of time and with an accordingly higher value will suffice. Physicians appreciate that E/M delivered via telephone is not the same as a check-in call to a patient, and the care provided requires similar time, effort, and cognitive load as video visits. The AGA and our sister societies plan to object to Medicare’s proposal to treat these services as “check-ins” with slightly higher payment and will continue to advocate for permanent coverage of the telephone E/M CPT codes and payment parity with in-person E/M visits.

The ugly

The Medicare Physician Fee Schedule (MPFS) conversion factor, the basis of Medicare payments, is proposed to be cut almost 11% percent from $36.09 in 2020 to $32.26 in 2021.

How it happened

Medicare agreed to implement coding and valuation changes to office and outpatient E/M codes (99202-99205, 99211-99215) in 2021 as recommended by the American Medical Association and widely supported by specialty societies. E/M services account for about 40% of all Medicare spending annually, which magnifies the impact of any changes to their relative value units (RVUs). By law, payment increases that occur from new work RVUs must be offset by a reduction, referred to as a budget-neutral adjustment, applied to offset the increase in total spending on the MPFS.²

CMS explained in the 2021 MPFS proposed rule, “If revisions to the RVUs cause expenditures for the year to change by more than $20 million, we make adjustments to ensure that expenditures do not increase or decrease by more than $20 million.” Medicare calculated that the corresponding adjustment to the conversion factor for 2021 needed to fall by nearly 11% to achieve budget neutrality. Because gastroenterologists report a significant portion of E/M in addition to performing procedures, the overall estimated impact is –5% of all reimbursement from Medicare.
 

What you can do

Visit the AGA Advocacy Action Center at https://gastro.quorum.us/AGAactioncenter/ and select “Fight back against CMS’s cuts to specialty care payments” to tell your lawmakers to stop these cuts and preserve care for patients by waiving Medicare’s budget neutrality requirements for E/M adjustments.

You can also use the AGA’s Medicare Physician Fee Schedule Calculator tool to determine the effect of the proposed cuts.³ By contacting AGA staff, Leslie Narramore, at [email protected] with the overall effect on your practice, you can help AGA use these data as we work with the physician community to urge Congress to prevent these payment cuts.
 

What AGA is doing

The AGA and our sister societies have joined the AMA and others in urging Congress and CMS to waive budget-neutrality rules for the implementation of the changes in E/M services effective 2021. We also joined with AMA and over 100 specialty societies in a letter asking Secretary of Health & Human Services Alex Azar that the agency use its authority under the public health emergency declaration to waive budget neutrality for the changes, given these difficult times for practices across the country.

What next steps to take

The AGA and our sister societies are developing comment letters in response to the proposals in the 2021 MPFS proposed rule. Medicare plans to publish its final decisions for 2021 in December. Please do your part by visiting the AGA Advocacy Action Center at https://gastro.quorum.us/AGAactioncenter/ to tell your lawmakers to stop the proposed 2021 payment cuts and preserve care for patients by waiving Medicare’s budget-neutrality requirements for E/M adjustments.

References

1. Serper M et al. Positive early patient and clinician experience with telemedicine in an academic gastroenterology practice during the COVID-19 pandemic [published online ahead of print, 2020 Jun 18]. Gastroenterology. 2020;S0016-5085(20)34834-4. doi: 10.1053/j.gastro.2020.06.034.

2. https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/MACRA-MIPS-and-APMs.

3. https://gastro.org/news/prepare-for-and-help-prevent-2021-medicare-cuts-to-gi/.

Dr. Gangarosa is professor of medicine, division of gastroenterology and hepatology, University of North Carolina at Chapel Hill School of Medicine, and chair of the AGA Government Affairs Committee; Dr. Mehta is associate chief innovation officer at Penn Medicine, Philadelphia, a gastroenterologist, assistant professor of medicine at the Perelman School of Medicine, senior fellow at the Leonard Davis Institute of Health Economics, affiliated faculty member at the Center for Health Incentives and Behavioral Economics, and AGA RUC Adviser. They have no conflicts of interest.

Payment cuts to nearly all of medicine, including gastroenterology, could be in store beginning Jan. 1, 2021. Physicians may also face elimination of some services the Centers for Medicare & Medicaid Services granted temporary access to during the coronavirus (COVID-19) pandemic according to CMS’s recently released policy and payment recommendations. These proposals could be implemented as physician practices are still recovering financially from states’ temporary ban on elective surgeries from March through May 2020 in response to the public health emergency (PHE) and continuing to deal with the clinical and financial challenges of the pandemic.

In early August, CMS proposed a number of changes for 2021 that affect physicians. There’s plenty of good, bad, and ugly in this proposed rule.
 

Let’s start with two positives (The good):

Medicare proposes to maintain the current values for colonoscopy with biopsy (45385) and esophagogastroduodenoscopy (EGD) with biopsy (43239). Despite a recent reevaluation of these codes in 2016 and 2014, respectively, Medicare conceded to Anthem’s suggestion that the procedures were not overvalued and needed another evaluation. The AGA and our sister societies’ data affirmed the current values and Medicare proposed to maintain them in 2021.

Medicare proposes to increase the price for scope video system equipment (ES031) from $36,306 to $70,673.38 and the suction machine (Gomco) (EQ235) from $1,981.66 to $3,195.85, phased in over 2 years. This will provide a small increase in the practice expense value for all GI endoscopy procedures. Since CMS began conducting a review of scope systems in 2017, the AGA and our sister societies have successfully worked to convince the Agency to increase its payment for GI endoscopes and associated equipment by providing invoices. We are pleased Medicare is updating these items to reflect more accurate costs.

Now onto items that could negatively affect the practice of gastroenterology.
 

The bad

Medicare proposes to stop covering and paying for telephone evaluation and management (E/M) visits as soon as the COVID-19 PHE expires. After originally denying that Medicare beneficiaries had trouble accessing video E/M visits and refusing to cover existing telephone (audio only) E/M codes 99441-99443, the agency responded to enormous pressure from AGA and other specialties and added the codes to its covered telehealth services list, setting the payment equal to office/outpatient established patient E/M codes 99212-99214 during the PHE. Telephone E/M has been a vital lifeline, allowing Medicare beneficiaries who don’t have a smart phone or reliable internet connection to access needed E/M services, while allowing them to stay safe at home during the PHE. There is evidence that our most vulnerable patients have the greatest need for telephone visits to advance their care.¹

Medicare’s proposal to stop covering and paying for telephone E/M visits as soon as the COVID-19 PHE expires, while disappointing, is not surprising because of the agency’s reluctance to admit they were needed in the first place. The agency believes that creating a new code for audio-only patient interactions similar to the virtual check-in code G2012 but for a longer unit of time and with an accordingly higher value will suffice. Physicians appreciate that E/M delivered via telephone is not the same as a check-in call to a patient, and the care provided requires similar time, effort, and cognitive load as video visits. The AGA and our sister societies plan to object to Medicare’s proposal to treat these services as “check-ins” with slightly higher payment and will continue to advocate for permanent coverage of the telephone E/M CPT codes and payment parity with in-person E/M visits.

The ugly

The Medicare Physician Fee Schedule (MPFS) conversion factor, the basis of Medicare payments, is proposed to be cut almost 11% percent from $36.09 in 2020 to $32.26 in 2021.

How it happened

Medicare agreed to implement coding and valuation changes to office and outpatient E/M codes (99202-99205, 99211-99215) in 2021 as recommended by the American Medical Association and widely supported by specialty societies. E/M services account for about 40% of all Medicare spending annually, which magnifies the impact of any changes to their relative value units (RVUs). By law, payment increases that occur from new work RVUs must be offset by a reduction, referred to as a budget-neutral adjustment, applied to offset the increase in total spending on the MPFS.²

CMS explained in the 2021 MPFS proposed rule, “If revisions to the RVUs cause expenditures for the year to change by more than $20 million, we make adjustments to ensure that expenditures do not increase or decrease by more than $20 million.” Medicare calculated that the corresponding adjustment to the conversion factor for 2021 needed to fall by nearly 11% to achieve budget neutrality. Because gastroenterologists report a significant portion of E/M in addition to performing procedures, the overall estimated impact is –5% of all reimbursement from Medicare.
 

What you can do

Visit the AGA Advocacy Action Center at https://gastro.quorum.us/AGAactioncenter/ and select “Fight back against CMS’s cuts to specialty care payments” to tell your lawmakers to stop these cuts and preserve care for patients by waiving Medicare’s budget neutrality requirements for E/M adjustments.

You can also use the AGA’s Medicare Physician Fee Schedule Calculator tool to determine the effect of the proposed cuts.³ By contacting AGA staff, Leslie Narramore, at [email protected] with the overall effect on your practice, you can help AGA use these data as we work with the physician community to urge Congress to prevent these payment cuts.
 

What AGA is doing

The AGA and our sister societies have joined the AMA and others in urging Congress and CMS to waive budget-neutrality rules for the implementation of the changes in E/M services effective 2021. We also joined with AMA and over 100 specialty societies in a letter asking Secretary of Health & Human Services Alex Azar that the agency use its authority under the public health emergency declaration to waive budget neutrality for the changes, given these difficult times for practices across the country.

What next steps to take

The AGA and our sister societies are developing comment letters in response to the proposals in the 2021 MPFS proposed rule. Medicare plans to publish its final decisions for 2021 in December. Please do your part by visiting the AGA Advocacy Action Center at https://gastro.quorum.us/AGAactioncenter/ to tell your lawmakers to stop the proposed 2021 payment cuts and preserve care for patients by waiving Medicare’s budget-neutrality requirements for E/M adjustments.

References

1. Serper M et al. Positive early patient and clinician experience with telemedicine in an academic gastroenterology practice during the COVID-19 pandemic [published online ahead of print, 2020 Jun 18]. Gastroenterology. 2020;S0016-5085(20)34834-4. doi: 10.1053/j.gastro.2020.06.034.

2. https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/MACRA-MIPS-and-APMs.

3. https://gastro.org/news/prepare-for-and-help-prevent-2021-medicare-cuts-to-gi/.

Dr. Gangarosa is professor of medicine, division of gastroenterology and hepatology, University of North Carolina at Chapel Hill School of Medicine, and chair of the AGA Government Affairs Committee; Dr. Mehta is associate chief innovation officer at Penn Medicine, Philadelphia, a gastroenterologist, assistant professor of medicine at the Perelman School of Medicine, senior fellow at the Leonard Davis Institute of Health Economics, affiliated faculty member at the Center for Health Incentives and Behavioral Economics, and AGA RUC Adviser. They have no conflicts of interest.

Payment cuts to nearly all of medicine, including gastroenterology, could be in store beginning Jan. 1, 2021. Physicians may also face elimination of some services the Centers for Medicare & Medicaid Services granted temporary access to during the coronavirus (COVID-19) pandemic according to CMS’s recently released policy and payment recommendations. These proposals could be implemented as physician practices are still recovering financially from states’ temporary ban on elective surgeries from March through May 2020 in response to the public health emergency (PHE) and continuing to deal with the clinical and financial challenges of the pandemic.

In early August, CMS proposed a number of changes for 2021 that affect physicians. There’s plenty of good, bad, and ugly in this proposed rule.
 

Let’s start with two positives (The good):

Medicare proposes to maintain the current values for colonoscopy with biopsy (45385) and esophagogastroduodenoscopy (EGD) with biopsy (43239). Despite a recent reevaluation of these codes in 2016 and 2014, respectively, Medicare conceded to Anthem’s suggestion that the procedures were not overvalued and needed another evaluation. The AGA and our sister societies’ data affirmed the current values and Medicare proposed to maintain them in 2021.

Medicare proposes to increase the price for scope video system equipment (ES031) from $36,306 to $70,673.38 and the suction machine (Gomco) (EQ235) from $1,981.66 to $3,195.85, phased in over 2 years. This will provide a small increase in the practice expense value for all GI endoscopy procedures. Since CMS began conducting a review of scope systems in 2017, the AGA and our sister societies have successfully worked to convince the Agency to increase its payment for GI endoscopes and associated equipment by providing invoices. We are pleased Medicare is updating these items to reflect more accurate costs.

Now onto items that could negatively affect the practice of gastroenterology.
 

The bad

Medicare proposes to stop covering and paying for telephone evaluation and management (E/M) visits as soon as the COVID-19 PHE expires. After originally denying that Medicare beneficiaries had trouble accessing video E/M visits and refusing to cover existing telephone (audio only) E/M codes 99441-99443, the agency responded to enormous pressure from AGA and other specialties and added the codes to its covered telehealth services list, setting the payment equal to office/outpatient established patient E/M codes 99212-99214 during the PHE. Telephone E/M has been a vital lifeline, allowing Medicare beneficiaries who don’t have a smart phone or reliable internet connection to access needed E/M services, while allowing them to stay safe at home during the PHE. There is evidence that our most vulnerable patients have the greatest need for telephone visits to advance their care.¹

Medicare’s proposal to stop covering and paying for telephone E/M visits as soon as the COVID-19 PHE expires, while disappointing, is not surprising because of the agency’s reluctance to admit they were needed in the first place. The agency believes that creating a new code for audio-only patient interactions similar to the virtual check-in code G2012 but for a longer unit of time and with an accordingly higher value will suffice. Physicians appreciate that E/M delivered via telephone is not the same as a check-in call to a patient, and the care provided requires similar time, effort, and cognitive load as video visits. The AGA and our sister societies plan to object to Medicare’s proposal to treat these services as “check-ins” with slightly higher payment and will continue to advocate for permanent coverage of the telephone E/M CPT codes and payment parity with in-person E/M visits.

The ugly

The Medicare Physician Fee Schedule (MPFS) conversion factor, the basis of Medicare payments, is proposed to be cut almost 11% percent from $36.09 in 2020 to $32.26 in 2021.

How it happened

Medicare agreed to implement coding and valuation changes to office and outpatient E/M codes (99202-99205, 99211-99215) in 2021 as recommended by the American Medical Association and widely supported by specialty societies. E/M services account for about 40% of all Medicare spending annually, which magnifies the impact of any changes to their relative value units (RVUs). By law, payment increases that occur from new work RVUs must be offset by a reduction, referred to as a budget-neutral adjustment, applied to offset the increase in total spending on the MPFS.²

CMS explained in the 2021 MPFS proposed rule, “If revisions to the RVUs cause expenditures for the year to change by more than $20 million, we make adjustments to ensure that expenditures do not increase or decrease by more than $20 million.” Medicare calculated that the corresponding adjustment to the conversion factor for 2021 needed to fall by nearly 11% to achieve budget neutrality. Because gastroenterologists report a significant portion of E/M in addition to performing procedures, the overall estimated impact is –5% of all reimbursement from Medicare.
 

What you can do

Visit the AGA Advocacy Action Center at https://gastro.quorum.us/AGAactioncenter/ and select “Fight back against CMS’s cuts to specialty care payments” to tell your lawmakers to stop these cuts and preserve care for patients by waiving Medicare’s budget neutrality requirements for E/M adjustments.

You can also use the AGA’s Medicare Physician Fee Schedule Calculator tool to determine the effect of the proposed cuts.³ By contacting AGA staff, Leslie Narramore, at [email protected] with the overall effect on your practice, you can help AGA use these data as we work with the physician community to urge Congress to prevent these payment cuts.
 

What AGA is doing

The AGA and our sister societies have joined the AMA and others in urging Congress and CMS to waive budget-neutrality rules for the implementation of the changes in E/M services effective 2021. We also joined with AMA and over 100 specialty societies in a letter asking Secretary of Health & Human Services Alex Azar that the agency use its authority under the public health emergency declaration to waive budget neutrality for the changes, given these difficult times for practices across the country.

What next steps to take

The AGA and our sister societies are developing comment letters in response to the proposals in the 2021 MPFS proposed rule. Medicare plans to publish its final decisions for 2021 in December. Please do your part by visiting the AGA Advocacy Action Center at https://gastro.quorum.us/AGAactioncenter/ to tell your lawmakers to stop the proposed 2021 payment cuts and preserve care for patients by waiving Medicare’s budget-neutrality requirements for E/M adjustments.

References

1. Serper M et al. Positive early patient and clinician experience with telemedicine in an academic gastroenterology practice during the COVID-19 pandemic [published online ahead of print, 2020 Jun 18]. Gastroenterology. 2020;S0016-5085(20)34834-4. doi: 10.1053/j.gastro.2020.06.034.

2. https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/MACRA-MIPS-and-APMs.

3. https://gastro.org/news/prepare-for-and-help-prevent-2021-medicare-cuts-to-gi/.

Dr. Gangarosa is professor of medicine, division of gastroenterology and hepatology, University of North Carolina at Chapel Hill School of Medicine, and chair of the AGA Government Affairs Committee; Dr. Mehta is associate chief innovation officer at Penn Medicine, Philadelphia, a gastroenterologist, assistant professor of medicine at the Perelman School of Medicine, senior fellow at the Leonard Davis Institute of Health Economics, affiliated faculty member at the Center for Health Incentives and Behavioral Economics, and AGA RUC Adviser. They have no conflicts of interest.

Americans sharply increased their alcohol intake last spring as many areas of the country shutdown because of the coronavirus pandemic, results of a national survey show.

Thinkstockphotos.com

The overall frequency of alcohol consumption increased by 14% among adults over age 30 in the spring of 2020 versus the same period a year earlier.

The increase was most evident in adults aged 30-59, women, and non-Hispanic Whites.

“Alcohol consumption can have significant negative health consequences, so this information suggests another way that the pandemic may be affecting the physical and mental health of Americans,” Michael Pollard, PhD, lead investigator and sociologist at Rand, said in a news release.

The results were published online as a research letter Sept. 29 in JAMA Network Open.

Booming business

After some U.S. states issued stay-at-home orders to fight the spread of SARS-CoV-2, one study noted a 54% increase in national sales of alcohol for the week ending March 21, 2020, relative to 1 year earlier and a 262% increase in online alcohol sales.

“We’ve had anecdotal information about people buying and consuming more alcohol,” Dr. Pollard said, but the Rand study provides the first survey-based information that shows how much alcohol consumption has increased during the pandemic.

The findings are based on 1,540 adults (mean age, 56.6 years; 57% women) from the Rand American Life Panel, a nationally representative sample of Americans who were surveyed about their alcohol consumption before the pandemic in the spring of 2019, and again in the spring of 2020 during the early months of the shutdown.

Overall, in spring 2020, respondents reported drinking alcohol 6.22 days in the prior month on average, a 14% increase from the monthly average of 5.48 days reported in spring 2019.

Among adults aged 30 to 59 years, the frequency of alcohol consumption increased from 4.98 days prepandemic to 5.91 days during the pandemic, a 19% increase.

Women reported drinking an average of 5.36 days in the prior month in the early pandemic period, a 17% increase from 4.58 monthly drinking days before the pandemic. 

In addition, compared with spring 2019, in spring 2020 women reported a 41% increase in heavy drinking days – four or more drinks in a couple of hours.

Independent of consumption level, nearly 1 in 10 women had an increase in alcohol-related problems in the pandemic period, based on responses to the Short Inventory of Problems scale.

For non-Hispanic White individuals, the overall frequency of alcohol intake rose 10% during the early pandemic period. 

“The population level changes for women, younger, and non-Hispanic White individuals highlight that health systems may need to educate consumers through print or online media about increased alcohol use during the pandemic and identify factors associated with susceptibility and resilience to the impacts of COVID-19,” write Dr. Pollard and colleagues.

The authors note it will be important to determine whether increases in alcohol use persist as the pandemic continues, and whether psychological and physical well-being are subsequently affected.

The study was supported by the National Institute of Alcohol Abuse and Alcoholism. The authors have reported no relevant financial relationships.

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

Americans sharply increased their alcohol intake last spring as many areas of the country shutdown because of the coronavirus pandemic, results of a national survey show.

Thinkstockphotos.com

The overall frequency of alcohol consumption increased by 14% among adults over age 30 in the spring of 2020 versus the same period a year earlier.

The increase was most evident in adults aged 30-59, women, and non-Hispanic Whites.

“Alcohol consumption can have significant negative health consequences, so this information suggests another way that the pandemic may be affecting the physical and mental health of Americans,” Michael Pollard, PhD, lead investigator and sociologist at Rand, said in a news release.

The results were published online as a research letter Sept. 29 in JAMA Network Open.

Booming business

After some U.S. states issued stay-at-home orders to fight the spread of SARS-CoV-2, one study noted a 54% increase in national sales of alcohol for the week ending March 21, 2020, relative to 1 year earlier and a 262% increase in online alcohol sales.

“We’ve had anecdotal information about people buying and consuming more alcohol,” Dr. Pollard said, but the Rand study provides the first survey-based information that shows how much alcohol consumption has increased during the pandemic.

The findings are based on 1,540 adults (mean age, 56.6 years; 57% women) from the Rand American Life Panel, a nationally representative sample of Americans who were surveyed about their alcohol consumption before the pandemic in the spring of 2019, and again in the spring of 2020 during the early months of the shutdown.

Overall, in spring 2020, respondents reported drinking alcohol 6.22 days in the prior month on average, a 14% increase from the monthly average of 5.48 days reported in spring 2019.

Among adults aged 30 to 59 years, the frequency of alcohol consumption increased from 4.98 days prepandemic to 5.91 days during the pandemic, a 19% increase.

Women reported drinking an average of 5.36 days in the prior month in the early pandemic period, a 17% increase from 4.58 monthly drinking days before the pandemic. 

In addition, compared with spring 2019, in spring 2020 women reported a 41% increase in heavy drinking days – four or more drinks in a couple of hours.

Independent of consumption level, nearly 1 in 10 women had an increase in alcohol-related problems in the pandemic period, based on responses to the Short Inventory of Problems scale.

For non-Hispanic White individuals, the overall frequency of alcohol intake rose 10% during the early pandemic period. 

“The population level changes for women, younger, and non-Hispanic White individuals highlight that health systems may need to educate consumers through print or online media about increased alcohol use during the pandemic and identify factors associated with susceptibility and resilience to the impacts of COVID-19,” write Dr. Pollard and colleagues.

The authors note it will be important to determine whether increases in alcohol use persist as the pandemic continues, and whether psychological and physical well-being are subsequently affected.

The study was supported by the National Institute of Alcohol Abuse and Alcoholism. The authors have reported no relevant financial relationships.

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

Americans sharply increased their alcohol intake last spring as many areas of the country shutdown because of the coronavirus pandemic, results of a national survey show.

Thinkstockphotos.com

The overall frequency of alcohol consumption increased by 14% among adults over age 30 in the spring of 2020 versus the same period a year earlier.

The increase was most evident in adults aged 30-59, women, and non-Hispanic Whites.

“Alcohol consumption can have significant negative health consequences, so this information suggests another way that the pandemic may be affecting the physical and mental health of Americans,” Michael Pollard, PhD, lead investigator and sociologist at Rand, said in a news release.

The results were published online as a research letter Sept. 29 in JAMA Network Open.

Booming business

After some U.S. states issued stay-at-home orders to fight the spread of SARS-CoV-2, one study noted a 54% increase in national sales of alcohol for the week ending March 21, 2020, relative to 1 year earlier and a 262% increase in online alcohol sales.

“We’ve had anecdotal information about people buying and consuming more alcohol,” Dr. Pollard said, but the Rand study provides the first survey-based information that shows how much alcohol consumption has increased during the pandemic.

The findings are based on 1,540 adults (mean age, 56.6 years; 57% women) from the Rand American Life Panel, a nationally representative sample of Americans who were surveyed about their alcohol consumption before the pandemic in the spring of 2019, and again in the spring of 2020 during the early months of the shutdown.

Overall, in spring 2020, respondents reported drinking alcohol 6.22 days in the prior month on average, a 14% increase from the monthly average of 5.48 days reported in spring 2019.

Among adults aged 30 to 59 years, the frequency of alcohol consumption increased from 4.98 days prepandemic to 5.91 days during the pandemic, a 19% increase.

Women reported drinking an average of 5.36 days in the prior month in the early pandemic period, a 17% increase from 4.58 monthly drinking days before the pandemic. 

In addition, compared with spring 2019, in spring 2020 women reported a 41% increase in heavy drinking days – four or more drinks in a couple of hours.

Independent of consumption level, nearly 1 in 10 women had an increase in alcohol-related problems in the pandemic period, based on responses to the Short Inventory of Problems scale.

For non-Hispanic White individuals, the overall frequency of alcohol intake rose 10% during the early pandemic period. 

“The population level changes for women, younger, and non-Hispanic White individuals highlight that health systems may need to educate consumers through print or online media about increased alcohol use during the pandemic and identify factors associated with susceptibility and resilience to the impacts of COVID-19,” write Dr. Pollard and colleagues.

The authors note it will be important to determine whether increases in alcohol use persist as the pandemic continues, and whether psychological and physical well-being are subsequently affected.

The study was supported by the National Institute of Alcohol Abuse and Alcoholism. The authors have reported no relevant financial relationships.

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

Join us for our new GI Forging Forward virtual symposia series, a practical educational training program covering timely topics for GIs through the lens of COVID-19. Experts in the field will present the latest COVID-19 findings, share proven strategies to communicate and manage disaster and crisis situations, and educate participants on evidence-based recommendations to meet today’s evolving needs. Upcoming topics will cover keeping you, your staff and patients safe, new approaches and training in research, leading in times of crisis, and rapid-response guideline development.

Registration for this month’s virtual webinars are now open:

• Meet NIH Leadership: Minorities health disparities, research and career development: Oct. 15, 2020, 5:30 p.m. EDT
• Effective leadership in times of crisis: Oct. 22, 2020, 5:30 p.m. EDT

For more information, visit www.gastro.org/GIForgingForward.

[email protected]

Join us for our new GI Forging Forward virtual symposia series, a practical educational training program covering timely topics for GIs through the lens of COVID-19. Experts in the field will present the latest COVID-19 findings, share proven strategies to communicate and manage disaster and crisis situations, and educate participants on evidence-based recommendations to meet today’s evolving needs. Upcoming topics will cover keeping you, your staff and patients safe, new approaches and training in research, leading in times of crisis, and rapid-response guideline development.

Registration for this month’s virtual webinars are now open:

• Meet NIH Leadership: Minorities health disparities, research and career development: Oct. 15, 2020, 5:30 p.m. EDT
• Effective leadership in times of crisis: Oct. 22, 2020, 5:30 p.m. EDT

For more information, visit www.gastro.org/GIForgingForward.

[email protected]

Join us for our new GI Forging Forward virtual symposia series, a practical educational training program covering timely topics for GIs through the lens of COVID-19. Experts in the field will present the latest COVID-19 findings, share proven strategies to communicate and manage disaster and crisis situations, and educate participants on evidence-based recommendations to meet today’s evolving needs. Upcoming topics will cover keeping you, your staff and patients safe, new approaches and training in research, leading in times of crisis, and rapid-response guideline development.

Registration for this month’s virtual webinars are now open:

• Meet NIH Leadership: Minorities health disparities, research and career development: Oct. 15, 2020, 5:30 p.m. EDT
• Effective leadership in times of crisis: Oct. 22, 2020, 5:30 p.m. EDT

For more information, visit www.gastro.org/GIForgingForward.

[email protected]