Alicia Ault

As the Food and Drug Administration focuses on other issues, companies, both big and small, are looking to boost physician and consumer interest in their “medical foods” – products that fall somewhere between drugs and supplements and promise to mitigate symptoms, or even address underlying pathologies, of a range of diseases.

Manufacturers now market an array of medical foods, ranging from powders and capsules for Alzheimer disease to low-protein spaghetti for chronic kidney disease (CKD). The FDA has not been completely absent; it takes a narrow view of what medical conditions qualify for treatment with food products and has warned some manufacturers that their misbranded products are acting more like unapproved drugs.

By the FDA’s definition, medical food is limited to products that provide crucial therapy for patients with inborn errors of metabolism (IEM). An example is specialized baby formula for infants with phenylketonuria. Unlike supplements, medical foods are supposed to be used under the supervision of a physician. This has prompted some sales reps to turn up in the clinic, and most manufacturers have online approval forms for doctors to sign. Manufacturers, advisers, and regulators were interviewed for a closer look at this burgeoning industry.
 

The market

The global market for medical foods – about $18 billion in 2019 – is expected to grow steadily in the near future. It is drawing more interest, especially in Europe, where medical foods are more accepted by physicians and consumers, Meghan Donnelly, MS, RDN, said in an interview. She is a registered dietitian who conducts physician outreach in the United States for Flavis, a division of Dr. Schär. That company, based in northern Italy, started out targeting IEMs but now also sells gluten-free foods for celiac disease and low-protein foods for CKD.

It is still a niche market in the United States – and isn’t likely to ever approach the size of the supplement market, according to Marcus Charuvastra, the managing director of Targeted Medical Pharma, which markets Theramine capsules for pain management, among many other products. But it could still be a big win for a manufacturer if they get a small slice of a big market, such as for Alzheimer disease.
 

Defining medical food

According to an update of the Orphan Drug Act in 1988, a medical food is “a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.” The FDA issued regulations to accompany that law in 1993 but has since only issued a guidance document that is not legally binding.

Medical foods are not drugs and they are not supplements (the latter are intended only for healthy people). The FDA doesn’t require formal approval of a medical food, but, by law, the ingredients must be generally recognized as safe, and manufacturers must follow good manufacturing practices. However, the agency has taken a narrow view of what conditions require medical foods.

Policing medical foods hasn’t been a priority for the FDA, which is why there has been a proliferation of products that don’t meet the FDA’s view of the statutory definition of medical foods, according to Miriam Guggenheim, a food and drug law attorney in Washington, D.C. The FDA usually takes enforcement action when it sees a risk to the public’s health.

The agency’s stance has led to confusion – among manufacturers, physicians, consumers, and even regulators – making the market a kind of Wild West, according to Paul Hyman, a Washington, D.C.–based attorney who has represented medical food companies.

George A. Burdock, PhD, an Orlando-based regulatory consultant who has worked with medical food makers, believes the FDA will be forced to expand their narrow definition. He foresees a reconsideration of many medical food products in light of an October 2019 White House executive order prohibiting federal agencies from issuing guidance in lieu of rules.
 

Manufacturers and the FDA differ

One example of a product about which regulators and manufacturers differ is Theramine, which is described as “specially designed to supply the nervous system with the fuel it needs to meet the altered metabolic requirements of chronic pain and inflammatory disorders.”

It is not considered a medical food by the FDA, and the company has had numerous discussions with the agency about their diverging views, according to Mr. Charuvastra. “We’ve had our warning letters and we’ve had our sit downs, and we just had an inspection.”

Targeted Medical Pharma continues to market its products as medical foods but steers away from making any claims that they are like drugs, he said.

Confusion about medical foods has been exposed in the California Workers’ Compensation System by Leslie Wilson, PhD, and colleagues at the University of California, San Francisco. They found that physicians regularly wrote medical food prescriptions for non–FDA-approved uses and that the system reimbursed the majority of the products at a cost of $15.5 million from 2011 to 2013. More than half of these prescriptions were for Theramine.

Dr. Wilson reported that, for most products, no evidence supported effectiveness, and they were frequently mislabeled – for all 36 that were studied, submissions for reimbursement were made using a National Drug Code, an impossibility because medical foods are not drugs, and 14 were labeled “Rx only.”
 

Big-name companies joining in

The FDA does not keep a list of approved medical foods or manufacturers. Both small businesses and big food companies like Danone, Nestlé, and Abbott are players. Most products are sold online.

In the United States, Danone’s Nutricia division sells formulas and low-protein foods for IEMs. They also sell Ketocal, a powder or ready-to-drink liquid that is pitched as a balanced medical food to simplify and optimize the ketogenic diet for children with intractable epilepsy. Yet the FDA does not include epilepsy among the conditions that medical foods can treat.

Nestlé sells traditional medical foods for IEMs and also markets a range of what it calls nutritional therapies for such conditions as irritable bowel syndrome and dysphagia.

Nestlé is a minority shareholder in Axona, a product originally developed by Accera (Cerecin as of 2018). Jacquelyn Campo, senior director of global communications at Nestlé Health Sciences, said that the company is not actively involved in the operations management of Cerecin. However, on its website, Nestlé touts Axona, which is only available in the United States, as a “medical food” that “is intended for the clinical dietary management of mild to moderate Alzheimer disease.” The Axona site claims that the main ingredient, caprylic triglyceride, is broken down into ketones that provide fuel to treat cerebral hypometabolism, a precursor to Alzheimer disease. In a 2009 study, daily dosing of a preliminary formulation was associated with improved cognitive performance compared with placebo in patients with mild to moderate Alzheimer disease.

In 2013, the FDA warned Accera that it was misbranding Axona as a medical food and that the therapeutic claims the company was making would make the product an unapproved drug. Ms. Campo said Nestlé is aware of the agency’s warning, but added, “to our knowledge, Cerecin provided answers to the issues raised by the FDA.”

With the goal of getting drug approval, Accera went on to test a tweaked formulation in a 400-patient randomized, placebo-controlled trial called NOURISH AD that ultimately failed. Nevertheless, Axona is still marketed as a medical food. It costs about $100 for a month’s supply.

Repeated requests for comment from Cerecin were not answered. Danielle Schor, an FDA spokesperson, said the agency will not discuss the status of individual products.
 

More disputes and insurance coverage

Mary Ann DeMarco, executive director of sales and marketing for the Scottsdale, Ariz.–based medical food maker Primus Pharmaceuticals, said the company believes its products fit within the FDA’s medical foods rubric.

These include Fosteum Plus capsules, which it markets “for the clinical dietary management of the metabolic processes of osteopenia and osteoporosis.” The capsules contain a combination of genistein, zinc, calcium, phosphate, vitamin K2, and vitamin D. As proof of effectiveness, the company cites clinical data on some of the ingredients – not the product itself.

Primus has run afoul of the FDA before when it similarly positioned another product, called Limbrel, as a medical food for osteoarthritis. From 2007 to 2017, the FDA received 194 adverse event reports associated with Limbrel, including reports of drug-induced liver injury, pancreatitis, and hypersensitivity pneumonitis. In December 2017, the agency urged Primus to recall Limbrel, a move that it said was “necessary to protect the public health and welfare.” Primus withdrew the product but laid out a defense of Limbrel on a devoted website.

The FDA would not comment any further, said Ms. Schor. Ms. DeMarco said that Primus is working with the FDA to bring Limbrel back to market.

A lack of insurance coverage – even for approved medical foods for IEMs – has frustrated advocates, parents, and manufacturers. They are putting their weight behind the Medical Nutrition Equity Act, which would mandate public and private payer coverage of medical foods for IEMs and digestive conditions such as Crohn disease. That 2019 House bill has 56 cosponsors; there is no Senate companion bill.

“If you can get reimbursement, it really makes the market,” for Primus and the other manufacturers, Mr. Hyman said.

Primus Pharmaceuticals has launched its own campaign, Cover My Medical Foods, to enlist consumers and others to the cause.
 

Partnering with advocates

Although its low-protein breads, pastas, and baking products are not considered medical foods by the FDA, Dr. Schär is marketing them as such in the United States. They are trying to make a mark in CKD, according to Ms. Donnelly. She added that Dr. Schär has been successful in Europe, where nutrition therapy is more integrated in the health care system.

In 2019, Flavis and the National Kidney Foundation joined forces to raise awareness of nutritional interventions and to build enthusiasm for the Flavis products. The partnership has now ended, mostly because Flavis could no longer afford it, according to Ms. Donnelly.

“Information on diet and nutrition is the most requested subject matter from the NKF,” said Anthony Gucciardo, senior vice president of strategic partnerships at the foundation. The partnership “has never been necessarily about promoting their products per se; it’s promoting a healthy diet and really a diet specific for CKD.”

The NKF developed cobranded materials on low-protein foods for physicians and a teaching tool they could use with patients. Consumers could access nutrition information and a discount on Flavis products on a dedicated webpage. The foundation didn’t describe the low-protein products as medical foods, said Mr. Gucciardo, even if Flavis promoted them as such.

In patients with CKD, dietary management can help prevent the progression to end-stage renal disease. Although Medicare covers medical nutrition therapy – in which patients receive personalized assessments and dietary advice – uptake is abysmally low, according to a 2018 study.

Dr. Burdock thinks low-protein foods for CKD do meet the FDA’s criteria for a medical food but that the agency might not necessarily agree with him. The FDA would not comment.
 

Physician beware

When it comes to medical foods, the FDA has often looked the other way because the ingredients may already have been proven safe and the danger to an individual or to the public’s health is relatively low, according to Dr. Burdock and Mr. Hyman.

However, if the agency “feels that a medical food will prevent people from seeking medical care or there is potential to defraud the public, it is justified in taking action against the company,” said Dr. Burdock.

According to Dr. Wilson, the pharmacist who reported on the inappropriate medical food prescriptions in the California system, the FDA could help by creating a list of approved medical foods. Physicians should take time to learn about the difference between medical foods and supplements, she said, adding that they should also not hesitate to “question the veracity of the claims for them.”

Ms. Guggenheim believed doctors need to know that, for the most part, these are not FDA-approved products. She emphasized the importance of evaluating the products and looking at the data of their impact on a disease or condition.

“Many of these companies strongly believe that the products work and help people, so clinicians need to be very data driven,” she said.

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

As the Food and Drug Administration focuses on other issues, companies, both big and small, are looking to boost physician and consumer interest in their “medical foods” – products that fall somewhere between drugs and supplements and promise to mitigate symptoms, or even address underlying pathologies, of a range of diseases.

Manufacturers now market an array of medical foods, ranging from powders and capsules for Alzheimer disease to low-protein spaghetti for chronic kidney disease (CKD). The FDA has not been completely absent; it takes a narrow view of what medical conditions qualify for treatment with food products and has warned some manufacturers that their misbranded products are acting more like unapproved drugs.

By the FDA’s definition, medical food is limited to products that provide crucial therapy for patients with inborn errors of metabolism (IEM). An example is specialized baby formula for infants with phenylketonuria. Unlike supplements, medical foods are supposed to be used under the supervision of a physician. This has prompted some sales reps to turn up in the clinic, and most manufacturers have online approval forms for doctors to sign. Manufacturers, advisers, and regulators were interviewed for a closer look at this burgeoning industry.
 

The market

The global market for medical foods – about $18 billion in 2019 – is expected to grow steadily in the near future. It is drawing more interest, especially in Europe, where medical foods are more accepted by physicians and consumers, Meghan Donnelly, MS, RDN, said in an interview. She is a registered dietitian who conducts physician outreach in the United States for Flavis, a division of Dr. Schär. That company, based in northern Italy, started out targeting IEMs but now also sells gluten-free foods for celiac disease and low-protein foods for CKD.

It is still a niche market in the United States – and isn’t likely to ever approach the size of the supplement market, according to Marcus Charuvastra, the managing director of Targeted Medical Pharma, which markets Theramine capsules for pain management, among many other products. But it could still be a big win for a manufacturer if they get a small slice of a big market, such as for Alzheimer disease.
 

Defining medical food

According to an update of the Orphan Drug Act in 1988, a medical food is “a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.” The FDA issued regulations to accompany that law in 1993 but has since only issued a guidance document that is not legally binding.

Medical foods are not drugs and they are not supplements (the latter are intended only for healthy people). The FDA doesn’t require formal approval of a medical food, but, by law, the ingredients must be generally recognized as safe, and manufacturers must follow good manufacturing practices. However, the agency has taken a narrow view of what conditions require medical foods.

Policing medical foods hasn’t been a priority for the FDA, which is why there has been a proliferation of products that don’t meet the FDA’s view of the statutory definition of medical foods, according to Miriam Guggenheim, a food and drug law attorney in Washington, D.C. The FDA usually takes enforcement action when it sees a risk to the public’s health.

The agency’s stance has led to confusion – among manufacturers, physicians, consumers, and even regulators – making the market a kind of Wild West, according to Paul Hyman, a Washington, D.C.–based attorney who has represented medical food companies.

George A. Burdock, PhD, an Orlando-based regulatory consultant who has worked with medical food makers, believes the FDA will be forced to expand their narrow definition. He foresees a reconsideration of many medical food products in light of an October 2019 White House executive order prohibiting federal agencies from issuing guidance in lieu of rules.
 

Manufacturers and the FDA differ

One example of a product about which regulators and manufacturers differ is Theramine, which is described as “specially designed to supply the nervous system with the fuel it needs to meet the altered metabolic requirements of chronic pain and inflammatory disorders.”

It is not considered a medical food by the FDA, and the company has had numerous discussions with the agency about their diverging views, according to Mr. Charuvastra. “We’ve had our warning letters and we’ve had our sit downs, and we just had an inspection.”

Targeted Medical Pharma continues to market its products as medical foods but steers away from making any claims that they are like drugs, he said.

Confusion about medical foods has been exposed in the California Workers’ Compensation System by Leslie Wilson, PhD, and colleagues at the University of California, San Francisco. They found that physicians regularly wrote medical food prescriptions for non–FDA-approved uses and that the system reimbursed the majority of the products at a cost of $15.5 million from 2011 to 2013. More than half of these prescriptions were for Theramine.

Dr. Wilson reported that, for most products, no evidence supported effectiveness, and they were frequently mislabeled – for all 36 that were studied, submissions for reimbursement were made using a National Drug Code, an impossibility because medical foods are not drugs, and 14 were labeled “Rx only.”
 

Big-name companies joining in

The FDA does not keep a list of approved medical foods or manufacturers. Both small businesses and big food companies like Danone, Nestlé, and Abbott are players. Most products are sold online.

In the United States, Danone’s Nutricia division sells formulas and low-protein foods for IEMs. They also sell Ketocal, a powder or ready-to-drink liquid that is pitched as a balanced medical food to simplify and optimize the ketogenic diet for children with intractable epilepsy. Yet the FDA does not include epilepsy among the conditions that medical foods can treat.

Nestlé sells traditional medical foods for IEMs and also markets a range of what it calls nutritional therapies for such conditions as irritable bowel syndrome and dysphagia.

Nestlé is a minority shareholder in Axona, a product originally developed by Accera (Cerecin as of 2018). Jacquelyn Campo, senior director of global communications at Nestlé Health Sciences, said that the company is not actively involved in the operations management of Cerecin. However, on its website, Nestlé touts Axona, which is only available in the United States, as a “medical food” that “is intended for the clinical dietary management of mild to moderate Alzheimer disease.” The Axona site claims that the main ingredient, caprylic triglyceride, is broken down into ketones that provide fuel to treat cerebral hypometabolism, a precursor to Alzheimer disease. In a 2009 study, daily dosing of a preliminary formulation was associated with improved cognitive performance compared with placebo in patients with mild to moderate Alzheimer disease.

In 2013, the FDA warned Accera that it was misbranding Axona as a medical food and that the therapeutic claims the company was making would make the product an unapproved drug. Ms. Campo said Nestlé is aware of the agency’s warning, but added, “to our knowledge, Cerecin provided answers to the issues raised by the FDA.”

With the goal of getting drug approval, Accera went on to test a tweaked formulation in a 400-patient randomized, placebo-controlled trial called NOURISH AD that ultimately failed. Nevertheless, Axona is still marketed as a medical food. It costs about $100 for a month’s supply.

Repeated requests for comment from Cerecin were not answered. Danielle Schor, an FDA spokesperson, said the agency will not discuss the status of individual products.
 

More disputes and insurance coverage

Mary Ann DeMarco, executive director of sales and marketing for the Scottsdale, Ariz.–based medical food maker Primus Pharmaceuticals, said the company believes its products fit within the FDA’s medical foods rubric.

These include Fosteum Plus capsules, which it markets “for the clinical dietary management of the metabolic processes of osteopenia and osteoporosis.” The capsules contain a combination of genistein, zinc, calcium, phosphate, vitamin K2, and vitamin D. As proof of effectiveness, the company cites clinical data on some of the ingredients – not the product itself.

Primus has run afoul of the FDA before when it similarly positioned another product, called Limbrel, as a medical food for osteoarthritis. From 2007 to 2017, the FDA received 194 adverse event reports associated with Limbrel, including reports of drug-induced liver injury, pancreatitis, and hypersensitivity pneumonitis. In December 2017, the agency urged Primus to recall Limbrel, a move that it said was “necessary to protect the public health and welfare.” Primus withdrew the product but laid out a defense of Limbrel on a devoted website.

The FDA would not comment any further, said Ms. Schor. Ms. DeMarco said that Primus is working with the FDA to bring Limbrel back to market.

A lack of insurance coverage – even for approved medical foods for IEMs – has frustrated advocates, parents, and manufacturers. They are putting their weight behind the Medical Nutrition Equity Act, which would mandate public and private payer coverage of medical foods for IEMs and digestive conditions such as Crohn disease. That 2019 House bill has 56 cosponsors; there is no Senate companion bill.

“If you can get reimbursement, it really makes the market,” for Primus and the other manufacturers, Mr. Hyman said.

Primus Pharmaceuticals has launched its own campaign, Cover My Medical Foods, to enlist consumers and others to the cause.
 

Partnering with advocates

Although its low-protein breads, pastas, and baking products are not considered medical foods by the FDA, Dr. Schär is marketing them as such in the United States. They are trying to make a mark in CKD, according to Ms. Donnelly. She added that Dr. Schär has been successful in Europe, where nutrition therapy is more integrated in the health care system.

In 2019, Flavis and the National Kidney Foundation joined forces to raise awareness of nutritional interventions and to build enthusiasm for the Flavis products. The partnership has now ended, mostly because Flavis could no longer afford it, according to Ms. Donnelly.

“Information on diet and nutrition is the most requested subject matter from the NKF,” said Anthony Gucciardo, senior vice president of strategic partnerships at the foundation. The partnership “has never been necessarily about promoting their products per se; it’s promoting a healthy diet and really a diet specific for CKD.”

The NKF developed cobranded materials on low-protein foods for physicians and a teaching tool they could use with patients. Consumers could access nutrition information and a discount on Flavis products on a dedicated webpage. The foundation didn’t describe the low-protein products as medical foods, said Mr. Gucciardo, even if Flavis promoted them as such.

In patients with CKD, dietary management can help prevent the progression to end-stage renal disease. Although Medicare covers medical nutrition therapy – in which patients receive personalized assessments and dietary advice – uptake is abysmally low, according to a 2018 study.

Dr. Burdock thinks low-protein foods for CKD do meet the FDA’s criteria for a medical food but that the agency might not necessarily agree with him. The FDA would not comment.
 

Physician beware

When it comes to medical foods, the FDA has often looked the other way because the ingredients may already have been proven safe and the danger to an individual or to the public’s health is relatively low, according to Dr. Burdock and Mr. Hyman.

However, if the agency “feels that a medical food will prevent people from seeking medical care or there is potential to defraud the public, it is justified in taking action against the company,” said Dr. Burdock.

According to Dr. Wilson, the pharmacist who reported on the inappropriate medical food prescriptions in the California system, the FDA could help by creating a list of approved medical foods. Physicians should take time to learn about the difference between medical foods and supplements, she said, adding that they should also not hesitate to “question the veracity of the claims for them.”

Ms. Guggenheim believed doctors need to know that, for the most part, these are not FDA-approved products. She emphasized the importance of evaluating the products and looking at the data of their impact on a disease or condition.

“Many of these companies strongly believe that the products work and help people, so clinicians need to be very data driven,” she said.

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

As the Food and Drug Administration focuses on other issues, companies, both big and small, are looking to boost physician and consumer interest in their “medical foods” – products that fall somewhere between drugs and supplements and promise to mitigate symptoms, or even address underlying pathologies, of a range of diseases.

Manufacturers now market an array of medical foods, ranging from powders and capsules for Alzheimer disease to low-protein spaghetti for chronic kidney disease (CKD). The FDA has not been completely absent; it takes a narrow view of what medical conditions qualify for treatment with food products and has warned some manufacturers that their misbranded products are acting more like unapproved drugs.

By the FDA’s definition, medical food is limited to products that provide crucial therapy for patients with inborn errors of metabolism (IEM). An example is specialized baby formula for infants with phenylketonuria. Unlike supplements, medical foods are supposed to be used under the supervision of a physician. This has prompted some sales reps to turn up in the clinic, and most manufacturers have online approval forms for doctors to sign. Manufacturers, advisers, and regulators were interviewed for a closer look at this burgeoning industry.
 

The market

The global market for medical foods – about $18 billion in 2019 – is expected to grow steadily in the near future. It is drawing more interest, especially in Europe, where medical foods are more accepted by physicians and consumers, Meghan Donnelly, MS, RDN, said in an interview. She is a registered dietitian who conducts physician outreach in the United States for Flavis, a division of Dr. Schär. That company, based in northern Italy, started out targeting IEMs but now also sells gluten-free foods for celiac disease and low-protein foods for CKD.

It is still a niche market in the United States – and isn’t likely to ever approach the size of the supplement market, according to Marcus Charuvastra, the managing director of Targeted Medical Pharma, which markets Theramine capsules for pain management, among many other products. But it could still be a big win for a manufacturer if they get a small slice of a big market, such as for Alzheimer disease.
 

Defining medical food

According to an update of the Orphan Drug Act in 1988, a medical food is “a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.” The FDA issued regulations to accompany that law in 1993 but has since only issued a guidance document that is not legally binding.

Medical foods are not drugs and they are not supplements (the latter are intended only for healthy people). The FDA doesn’t require formal approval of a medical food, but, by law, the ingredients must be generally recognized as safe, and manufacturers must follow good manufacturing practices. However, the agency has taken a narrow view of what conditions require medical foods.

Policing medical foods hasn’t been a priority for the FDA, which is why there has been a proliferation of products that don’t meet the FDA’s view of the statutory definition of medical foods, according to Miriam Guggenheim, a food and drug law attorney in Washington, D.C. The FDA usually takes enforcement action when it sees a risk to the public’s health.

The agency’s stance has led to confusion – among manufacturers, physicians, consumers, and even regulators – making the market a kind of Wild West, according to Paul Hyman, a Washington, D.C.–based attorney who has represented medical food companies.

George A. Burdock, PhD, an Orlando-based regulatory consultant who has worked with medical food makers, believes the FDA will be forced to expand their narrow definition. He foresees a reconsideration of many medical food products in light of an October 2019 White House executive order prohibiting federal agencies from issuing guidance in lieu of rules.
 

Manufacturers and the FDA differ

One example of a product about which regulators and manufacturers differ is Theramine, which is described as “specially designed to supply the nervous system with the fuel it needs to meet the altered metabolic requirements of chronic pain and inflammatory disorders.”

It is not considered a medical food by the FDA, and the company has had numerous discussions with the agency about their diverging views, according to Mr. Charuvastra. “We’ve had our warning letters and we’ve had our sit downs, and we just had an inspection.”

Targeted Medical Pharma continues to market its products as medical foods but steers away from making any claims that they are like drugs, he said.

Confusion about medical foods has been exposed in the California Workers’ Compensation System by Leslie Wilson, PhD, and colleagues at the University of California, San Francisco. They found that physicians regularly wrote medical food prescriptions for non–FDA-approved uses and that the system reimbursed the majority of the products at a cost of $15.5 million from 2011 to 2013. More than half of these prescriptions were for Theramine.

Dr. Wilson reported that, for most products, no evidence supported effectiveness, and they were frequently mislabeled – for all 36 that were studied, submissions for reimbursement were made using a National Drug Code, an impossibility because medical foods are not drugs, and 14 were labeled “Rx only.”
 

Big-name companies joining in

The FDA does not keep a list of approved medical foods or manufacturers. Both small businesses and big food companies like Danone, Nestlé, and Abbott are players. Most products are sold online.

In the United States, Danone’s Nutricia division sells formulas and low-protein foods for IEMs. They also sell Ketocal, a powder or ready-to-drink liquid that is pitched as a balanced medical food to simplify and optimize the ketogenic diet for children with intractable epilepsy. Yet the FDA does not include epilepsy among the conditions that medical foods can treat.

Nestlé sells traditional medical foods for IEMs and also markets a range of what it calls nutritional therapies for such conditions as irritable bowel syndrome and dysphagia.

Nestlé is a minority shareholder in Axona, a product originally developed by Accera (Cerecin as of 2018). Jacquelyn Campo, senior director of global communications at Nestlé Health Sciences, said that the company is not actively involved in the operations management of Cerecin. However, on its website, Nestlé touts Axona, which is only available in the United States, as a “medical food” that “is intended for the clinical dietary management of mild to moderate Alzheimer disease.” The Axona site claims that the main ingredient, caprylic triglyceride, is broken down into ketones that provide fuel to treat cerebral hypometabolism, a precursor to Alzheimer disease. In a 2009 study, daily dosing of a preliminary formulation was associated with improved cognitive performance compared with placebo in patients with mild to moderate Alzheimer disease.

In 2013, the FDA warned Accera that it was misbranding Axona as a medical food and that the therapeutic claims the company was making would make the product an unapproved drug. Ms. Campo said Nestlé is aware of the agency’s warning, but added, “to our knowledge, Cerecin provided answers to the issues raised by the FDA.”

With the goal of getting drug approval, Accera went on to test a tweaked formulation in a 400-patient randomized, placebo-controlled trial called NOURISH AD that ultimately failed. Nevertheless, Axona is still marketed as a medical food. It costs about $100 for a month’s supply.

Repeated requests for comment from Cerecin were not answered. Danielle Schor, an FDA spokesperson, said the agency will not discuss the status of individual products.
 

More disputes and insurance coverage

Mary Ann DeMarco, executive director of sales and marketing for the Scottsdale, Ariz.–based medical food maker Primus Pharmaceuticals, said the company believes its products fit within the FDA’s medical foods rubric.

These include Fosteum Plus capsules, which it markets “for the clinical dietary management of the metabolic processes of osteopenia and osteoporosis.” The capsules contain a combination of genistein, zinc, calcium, phosphate, vitamin K2, and vitamin D. As proof of effectiveness, the company cites clinical data on some of the ingredients – not the product itself.

Primus has run afoul of the FDA before when it similarly positioned another product, called Limbrel, as a medical food for osteoarthritis. From 2007 to 2017, the FDA received 194 adverse event reports associated with Limbrel, including reports of drug-induced liver injury, pancreatitis, and hypersensitivity pneumonitis. In December 2017, the agency urged Primus to recall Limbrel, a move that it said was “necessary to protect the public health and welfare.” Primus withdrew the product but laid out a defense of Limbrel on a devoted website.

The FDA would not comment any further, said Ms. Schor. Ms. DeMarco said that Primus is working with the FDA to bring Limbrel back to market.

A lack of insurance coverage – even for approved medical foods for IEMs – has frustrated advocates, parents, and manufacturers. They are putting their weight behind the Medical Nutrition Equity Act, which would mandate public and private payer coverage of medical foods for IEMs and digestive conditions such as Crohn disease. That 2019 House bill has 56 cosponsors; there is no Senate companion bill.

“If you can get reimbursement, it really makes the market,” for Primus and the other manufacturers, Mr. Hyman said.

Primus Pharmaceuticals has launched its own campaign, Cover My Medical Foods, to enlist consumers and others to the cause.
 

Partnering with advocates

Although its low-protein breads, pastas, and baking products are not considered medical foods by the FDA, Dr. Schär is marketing them as such in the United States. They are trying to make a mark in CKD, according to Ms. Donnelly. She added that Dr. Schär has been successful in Europe, where nutrition therapy is more integrated in the health care system.

In 2019, Flavis and the National Kidney Foundation joined forces to raise awareness of nutritional interventions and to build enthusiasm for the Flavis products. The partnership has now ended, mostly because Flavis could no longer afford it, according to Ms. Donnelly.

“Information on diet and nutrition is the most requested subject matter from the NKF,” said Anthony Gucciardo, senior vice president of strategic partnerships at the foundation. The partnership “has never been necessarily about promoting their products per se; it’s promoting a healthy diet and really a diet specific for CKD.”

The NKF developed cobranded materials on low-protein foods for physicians and a teaching tool they could use with patients. Consumers could access nutrition information and a discount on Flavis products on a dedicated webpage. The foundation didn’t describe the low-protein products as medical foods, said Mr. Gucciardo, even if Flavis promoted them as such.

In patients with CKD, dietary management can help prevent the progression to end-stage renal disease. Although Medicare covers medical nutrition therapy – in which patients receive personalized assessments and dietary advice – uptake is abysmally low, according to a 2018 study.

Dr. Burdock thinks low-protein foods for CKD do meet the FDA’s criteria for a medical food but that the agency might not necessarily agree with him. The FDA would not comment.
 

Physician beware

When it comes to medical foods, the FDA has often looked the other way because the ingredients may already have been proven safe and the danger to an individual or to the public’s health is relatively low, according to Dr. Burdock and Mr. Hyman.

However, if the agency “feels that a medical food will prevent people from seeking medical care or there is potential to defraud the public, it is justified in taking action against the company,” said Dr. Burdock.

According to Dr. Wilson, the pharmacist who reported on the inappropriate medical food prescriptions in the California system, the FDA could help by creating a list of approved medical foods. Physicians should take time to learn about the difference between medical foods and supplements, she said, adding that they should also not hesitate to “question the veracity of the claims for them.”

Ms. Guggenheim believed doctors need to know that, for the most part, these are not FDA-approved products. She emphasized the importance of evaluating the products and looking at the data of their impact on a disease or condition.

“Many of these companies strongly believe that the products work and help people, so clinicians need to be very data driven,” she said.

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

The Pharmaceutical Research and Manufacturers Association (PhRMA) is suing the state of Minnesota in an attempt to overturn a law that requires insulin makers to provide an emergency supply to individuals free of charge.

PhRMA filed the complaint in the U.S. District Court in Minnesota on July 1, the day the Alec Smith Insulin Affordability Act went into effect. The law created the Minnesota Insulin Safety Net Program, which is continuing to operate in the meantime.

Advocates said they were appalled by the PhRMA action.
 

PhRMA says law is unconstitutional

In the filing, PhRMA’s attorneys said the law is unconstitutional. It “order[s] pharmaceutical manufacturers to give insulin to state residents, on the state’s prescribed terms, at no charge to the recipients and without compensating the manufacturers in any way.”

“A state cannot simply commandeer private property to achieve its public policy goals,” the PhRMA lawyers argued.

The suit said the three leading insulin makers already provide discounts, copayment assistance, and free insulin to “a great number of patients.”

The state has estimated that as many as 30,000 Minnesotans would be eligible for free insulin in the first year of the program. The drugmakers strenuously objected, noting that would mean they would “be compelled to provide 173,800 monthly supplies of free insulin” just in the first year.

“No one living with diabetes should be forced to ration or go without their life-saving insulin because they can’t afford it,” said PhRMA executive vice president and general counsel James C. Stansel in a statement.

The law, said Mr. Stansel, “overlooks common sense solutions to help patients afford their insulin and, despite its claims, still allows for patients to be charged at the pharmacy for the insulin that manufacturers are required to provide for free.”
 

Advocates decry suit

Advocates had worked for several years to secure passage of the legislation, named in honor of a young man who died in 2017 after rationing his insulin. Minnesota Gov. Tim Walz of the Democratic-Farmer-Labor Party signed the bill into law on April 15.

It requires manufacturers to make at least a 30-day supply of insulin available to those who are in urgent need and cannot afford the medication. Manufacturers can be fined $200,000 per month for not complying.

Mayo Clinic hematologist S. Vincent Rajkumar, MD, who called for action on the cost of insulin in an article published in the January 2020 issue of the Mayo Clinic Proceedings, as reported by Medscape Medical News, said the lawsuit was a “bad move.”

Dr. Rajkumar, the Edward W. and Betty Knight Scripps professor of medicine at the Mayo Clinic, noted that it has strict limits and is aimed to help patients in emergent need.

“There is nothing in the US constitution that prevents states from saving the lives of its citizens who are in imminent danger,” Dr. Rajkumar said. “The only motives for this lawsuit in my opinion are greed and the worry that other states may also choose to put lives of patients ahead of pharma profits.”

Alec Smith’s mother, Nicole Smith-Holt, who is active with T1International’s #insulin4all campaign, took to Twitter to express her anger.

“Throwing up road blocks to securing affordable insulin for the people of MN, haven’t they taken enough innocent lives? How many more bodies are they looking for?” she tweeted. “When are they going to realize we are not going to stop fighting?”

T1International said in a statement: “It is clear that the pharmaceutical industry can see only one thing – their bottom line,” and promised that patients would not give up.

“We will not stop showing them the real price we pay for their greed,” said the organization.

Abigail Hansmeyer, a Minnesota-based #insulin4all advocate, also talked about her frustration at what appeared to be disingenuous behavior by the insulin makers.

“I guess the endless opportunities insulin manufacturer reps had as stakeholders during numerous discussions and negotiations in the making of this law, wasn’t what they wanted,” she tweeted. “They were buying time to protect their profits. Yeah, we’re not done here.”

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

The Pharmaceutical Research and Manufacturers Association (PhRMA) is suing the state of Minnesota in an attempt to overturn a law that requires insulin makers to provide an emergency supply to individuals free of charge.

PhRMA filed the complaint in the U.S. District Court in Minnesota on July 1, the day the Alec Smith Insulin Affordability Act went into effect. The law created the Minnesota Insulin Safety Net Program, which is continuing to operate in the meantime.

Advocates said they were appalled by the PhRMA action.
 

PhRMA says law is unconstitutional

In the filing, PhRMA’s attorneys said the law is unconstitutional. It “order[s] pharmaceutical manufacturers to give insulin to state residents, on the state’s prescribed terms, at no charge to the recipients and without compensating the manufacturers in any way.”

“A state cannot simply commandeer private property to achieve its public policy goals,” the PhRMA lawyers argued.

The suit said the three leading insulin makers already provide discounts, copayment assistance, and free insulin to “a great number of patients.”

The state has estimated that as many as 30,000 Minnesotans would be eligible for free insulin in the first year of the program. The drugmakers strenuously objected, noting that would mean they would “be compelled to provide 173,800 monthly supplies of free insulin” just in the first year.

“No one living with diabetes should be forced to ration or go without their life-saving insulin because they can’t afford it,” said PhRMA executive vice president and general counsel James C. Stansel in a statement.

The law, said Mr. Stansel, “overlooks common sense solutions to help patients afford their insulin and, despite its claims, still allows for patients to be charged at the pharmacy for the insulin that manufacturers are required to provide for free.”
 

Advocates decry suit

Advocates had worked for several years to secure passage of the legislation, named in honor of a young man who died in 2017 after rationing his insulin. Minnesota Gov. Tim Walz of the Democratic-Farmer-Labor Party signed the bill into law on April 15.

It requires manufacturers to make at least a 30-day supply of insulin available to those who are in urgent need and cannot afford the medication. Manufacturers can be fined $200,000 per month for not complying.

Mayo Clinic hematologist S. Vincent Rajkumar, MD, who called for action on the cost of insulin in an article published in the January 2020 issue of the Mayo Clinic Proceedings, as reported by Medscape Medical News, said the lawsuit was a “bad move.”

Dr. Rajkumar, the Edward W. and Betty Knight Scripps professor of medicine at the Mayo Clinic, noted that it has strict limits and is aimed to help patients in emergent need.

“There is nothing in the US constitution that prevents states from saving the lives of its citizens who are in imminent danger,” Dr. Rajkumar said. “The only motives for this lawsuit in my opinion are greed and the worry that other states may also choose to put lives of patients ahead of pharma profits.”

Alec Smith’s mother, Nicole Smith-Holt, who is active with T1International’s #insulin4all campaign, took to Twitter to express her anger.

“Throwing up road blocks to securing affordable insulin for the people of MN, haven’t they taken enough innocent lives? How many more bodies are they looking for?” she tweeted. “When are they going to realize we are not going to stop fighting?”

T1International said in a statement: “It is clear that the pharmaceutical industry can see only one thing – their bottom line,” and promised that patients would not give up.

“We will not stop showing them the real price we pay for their greed,” said the organization.

Abigail Hansmeyer, a Minnesota-based #insulin4all advocate, also talked about her frustration at what appeared to be disingenuous behavior by the insulin makers.

“I guess the endless opportunities insulin manufacturer reps had as stakeholders during numerous discussions and negotiations in the making of this law, wasn’t what they wanted,” she tweeted. “They were buying time to protect their profits. Yeah, we’re not done here.”

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

The Pharmaceutical Research and Manufacturers Association (PhRMA) is suing the state of Minnesota in an attempt to overturn a law that requires insulin makers to provide an emergency supply to individuals free of charge.

PhRMA filed the complaint in the U.S. District Court in Minnesota on July 1, the day the Alec Smith Insulin Affordability Act went into effect. The law created the Minnesota Insulin Safety Net Program, which is continuing to operate in the meantime.

Advocates said they were appalled by the PhRMA action.
 

PhRMA says law is unconstitutional

In the filing, PhRMA’s attorneys said the law is unconstitutional. It “order[s] pharmaceutical manufacturers to give insulin to state residents, on the state’s prescribed terms, at no charge to the recipients and without compensating the manufacturers in any way.”

“A state cannot simply commandeer private property to achieve its public policy goals,” the PhRMA lawyers argued.

The suit said the three leading insulin makers already provide discounts, copayment assistance, and free insulin to “a great number of patients.”

The state has estimated that as many as 30,000 Minnesotans would be eligible for free insulin in the first year of the program. The drugmakers strenuously objected, noting that would mean they would “be compelled to provide 173,800 monthly supplies of free insulin” just in the first year.

“No one living with diabetes should be forced to ration or go without their life-saving insulin because they can’t afford it,” said PhRMA executive vice president and general counsel James C. Stansel in a statement.

The law, said Mr. Stansel, “overlooks common sense solutions to help patients afford their insulin and, despite its claims, still allows for patients to be charged at the pharmacy for the insulin that manufacturers are required to provide for free.”
 

Advocates decry suit

Advocates had worked for several years to secure passage of the legislation, named in honor of a young man who died in 2017 after rationing his insulin. Minnesota Gov. Tim Walz of the Democratic-Farmer-Labor Party signed the bill into law on April 15.

It requires manufacturers to make at least a 30-day supply of insulin available to those who are in urgent need and cannot afford the medication. Manufacturers can be fined $200,000 per month for not complying.

Mayo Clinic hematologist S. Vincent Rajkumar, MD, who called for action on the cost of insulin in an article published in the January 2020 issue of the Mayo Clinic Proceedings, as reported by Medscape Medical News, said the lawsuit was a “bad move.”

Dr. Rajkumar, the Edward W. and Betty Knight Scripps professor of medicine at the Mayo Clinic, noted that it has strict limits and is aimed to help patients in emergent need.

“There is nothing in the US constitution that prevents states from saving the lives of its citizens who are in imminent danger,” Dr. Rajkumar said. “The only motives for this lawsuit in my opinion are greed and the worry that other states may also choose to put lives of patients ahead of pharma profits.”

Alec Smith’s mother, Nicole Smith-Holt, who is active with T1International’s #insulin4all campaign, took to Twitter to express her anger.

“Throwing up road blocks to securing affordable insulin for the people of MN, haven’t they taken enough innocent lives? How many more bodies are they looking for?” she tweeted. “When are they going to realize we are not going to stop fighting?”

T1International said in a statement: “It is clear that the pharmaceutical industry can see only one thing – their bottom line,” and promised that patients would not give up.

“We will not stop showing them the real price we pay for their greed,” said the organization.

Abigail Hansmeyer, a Minnesota-based #insulin4all advocate, also talked about her frustration at what appeared to be disingenuous behavior by the insulin makers.

“I guess the endless opportunities insulin manufacturer reps had as stakeholders during numerous discussions and negotiations in the making of this law, wasn’t what they wanted,” she tweeted. “They were buying time to protect their profits. Yeah, we’re not done here.”

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

Participants in the growing #WhiteCoats4BlackLives protest against racism say it is a chance to use their status as trusted messengers, show themselves as allies of people of color, and demonstrate that they are intimately familiar with how racism has contributed to health disparities, like those on vivid display during the COVID-19 pandemic.

Sporadic protests – with participants in scrubs or white coats kneeling for 8 minutes and 46 seconds in memory of George Floyd – have quickly grown into organized, ongoing, large-scale events at hospitals, medical campuses, and city centers in New York, Indianapolis, Atlanta, Austin, Houston, Boston, Miami, Portland, Sacramento, Los Angeles, Philadelphia, and Albuquerque, among others.

Sarah Mariano

Now is different

Some residents said they felt particularly moved to act now – as the country entered a second week of protests in response to George Floyd’s death and as the COVID-19 pandemic highlighted the devastating toll of health disparities.

“This protest feels different to me,” said Ian Fields, MD, a urogynecology fellow at Oregon Health Sciences University (OHSU) School of Medicine. “The events over the last couple of weeks were just a big catalyst for this to explode,” he said.

“I was very intent, as a white male physician, just coming to acknowledge the privilege that I have, and to do something,” Dr. Fields said, adding that as an obstetrician-gynecologist, he sees the results of health disparities daily. He took part in a kneel-in and demonstration with OHSU colleagues on June 2 at Portland’s Pioneer Courthouse Square.

It’s okay to be sad and mourn, Dr. Fields said, but, he added, “nobody needs our tears necessarily right now. They need us to show up and to speak up about what we see going on.”

“It feels like it’s a national conversation,” said Dr. Verghese. The White Coats movement is “not an issue that’s confined to the black community – this is not an issue that’s a ‘black thing’ – this is a humanitarian thing,” she said.

Dr. Verghese, an Indian American who said that no one would mistake her for being white, said she still wants to acknowledge that she has privilege, as well as biases. All the patients in the COVID-19 unit where she works are African American, but she said she hadn’t initially noticed.

“What’s shocking is that I didn’t think about it,” she said. “I do have to recognize my own biases.”

Protesting During a Pandemic

Despite the demands of treating COVID-19 patients, healthcare professionals have made the White Coat protests a priority, they said. Most – but not all – of the White Coats protests have been on medical campuses, allowing health care professionals to quickly assemble and get back to work. Plus, all of the protests have called on attendees to march and gather safely – with masks and distancing.

“Seeing that we are working in the hospital, it’s important for us to be wearing our masks, to be social distancing,” Dr. Azu said. Organizers asked attendees to ensure that they protested in a way that kept them “from worsening the COVID epidemic,” said Dr. Azu.

Unlike many others, the first protest in Portland was in conjunction with a larger group that assembles every evening in the square, said Dr. Fields. The physician protesters were wearing masks and maintaining distance from each other, especially when they kneeled, he said.

The protests have provided an escape from the futility of not being able to do anything for COVID-19 patients except to provide support, said Dr. Verghese. “In so many ways, we find ourselves powerless,” she said.

Protesting, Dr. Verghese added, was “one tiny moment where I got to regain my sense of agency, that I could actually do something about this.”

This article first appeared on Medscape.com.

Participants in the growing #WhiteCoats4BlackLives protest against racism say it is a chance to use their status as trusted messengers, show themselves as allies of people of color, and demonstrate that they are intimately familiar with how racism has contributed to health disparities, like those on vivid display during the COVID-19 pandemic.

Sporadic protests – with participants in scrubs or white coats kneeling for 8 minutes and 46 seconds in memory of George Floyd – have quickly grown into organized, ongoing, large-scale events at hospitals, medical campuses, and city centers in New York, Indianapolis, Atlanta, Austin, Houston, Boston, Miami, Portland, Sacramento, Los Angeles, Philadelphia, and Albuquerque, among others.

Sarah Mariano

Now is different

Some residents said they felt particularly moved to act now – as the country entered a second week of protests in response to George Floyd’s death and as the COVID-19 pandemic highlighted the devastating toll of health disparities.

“This protest feels different to me,” said Ian Fields, MD, a urogynecology fellow at Oregon Health Sciences University (OHSU) School of Medicine. “The events over the last couple of weeks were just a big catalyst for this to explode,” he said.

“I was very intent, as a white male physician, just coming to acknowledge the privilege that I have, and to do something,” Dr. Fields said, adding that as an obstetrician-gynecologist, he sees the results of health disparities daily. He took part in a kneel-in and demonstration with OHSU colleagues on June 2 at Portland’s Pioneer Courthouse Square.

It’s okay to be sad and mourn, Dr. Fields said, but, he added, “nobody needs our tears necessarily right now. They need us to show up and to speak up about what we see going on.”

“It feels like it’s a national conversation,” said Dr. Verghese. The White Coats movement is “not an issue that’s confined to the black community – this is not an issue that’s a ‘black thing’ – this is a humanitarian thing,” she said.

Dr. Verghese, an Indian American who said that no one would mistake her for being white, said she still wants to acknowledge that she has privilege, as well as biases. All the patients in the COVID-19 unit where she works are African American, but she said she hadn’t initially noticed.

“What’s shocking is that I didn’t think about it,” she said. “I do have to recognize my own biases.”

Protesting During a Pandemic

Despite the demands of treating COVID-19 patients, healthcare professionals have made the White Coat protests a priority, they said. Most – but not all – of the White Coats protests have been on medical campuses, allowing health care professionals to quickly assemble and get back to work. Plus, all of the protests have called on attendees to march and gather safely – with masks and distancing.

“Seeing that we are working in the hospital, it’s important for us to be wearing our masks, to be social distancing,” Dr. Azu said. Organizers asked attendees to ensure that they protested in a way that kept them “from worsening the COVID epidemic,” said Dr. Azu.

Unlike many others, the first protest in Portland was in conjunction with a larger group that assembles every evening in the square, said Dr. Fields. The physician protesters were wearing masks and maintaining distance from each other, especially when they kneeled, he said.

The protests have provided an escape from the futility of not being able to do anything for COVID-19 patients except to provide support, said Dr. Verghese. “In so many ways, we find ourselves powerless,” she said.

Protesting, Dr. Verghese added, was “one tiny moment where I got to regain my sense of agency, that I could actually do something about this.”

This article first appeared on Medscape.com.

Participants in the growing #WhiteCoats4BlackLives protest against racism say it is a chance to use their status as trusted messengers, show themselves as allies of people of color, and demonstrate that they are intimately familiar with how racism has contributed to health disparities, like those on vivid display during the COVID-19 pandemic.

Sporadic protests – with participants in scrubs or white coats kneeling for 8 minutes and 46 seconds in memory of George Floyd – have quickly grown into organized, ongoing, large-scale events at hospitals, medical campuses, and city centers in New York, Indianapolis, Atlanta, Austin, Houston, Boston, Miami, Portland, Sacramento, Los Angeles, Philadelphia, and Albuquerque, among others.

Sarah Mariano

Now is different

Some residents said they felt particularly moved to act now – as the country entered a second week of protests in response to George Floyd’s death and as the COVID-19 pandemic highlighted the devastating toll of health disparities.

“This protest feels different to me,” said Ian Fields, MD, a urogynecology fellow at Oregon Health Sciences University (OHSU) School of Medicine. “The events over the last couple of weeks were just a big catalyst for this to explode,” he said.

“I was very intent, as a white male physician, just coming to acknowledge the privilege that I have, and to do something,” Dr. Fields said, adding that as an obstetrician-gynecologist, he sees the results of health disparities daily. He took part in a kneel-in and demonstration with OHSU colleagues on June 2 at Portland’s Pioneer Courthouse Square.

It’s okay to be sad and mourn, Dr. Fields said, but, he added, “nobody needs our tears necessarily right now. They need us to show up and to speak up about what we see going on.”

“It feels like it’s a national conversation,” said Dr. Verghese. The White Coats movement is “not an issue that’s confined to the black community – this is not an issue that’s a ‘black thing’ – this is a humanitarian thing,” she said.

Dr. Verghese, an Indian American who said that no one would mistake her for being white, said she still wants to acknowledge that she has privilege, as well as biases. All the patients in the COVID-19 unit where she works are African American, but she said she hadn’t initially noticed.

“What’s shocking is that I didn’t think about it,” she said. “I do have to recognize my own biases.”

Protesting During a Pandemic

Despite the demands of treating COVID-19 patients, healthcare professionals have made the White Coat protests a priority, they said. Most – but not all – of the White Coats protests have been on medical campuses, allowing health care professionals to quickly assemble and get back to work. Plus, all of the protests have called on attendees to march and gather safely – with masks and distancing.

“Seeing that we are working in the hospital, it’s important for us to be wearing our masks, to be social distancing,” Dr. Azu said. Organizers asked attendees to ensure that they protested in a way that kept them “from worsening the COVID epidemic,” said Dr. Azu.

Unlike many others, the first protest in Portland was in conjunction with a larger group that assembles every evening in the square, said Dr. Fields. The physician protesters were wearing masks and maintaining distance from each other, especially when they kneeled, he said.

The protests have provided an escape from the futility of not being able to do anything for COVID-19 patients except to provide support, said Dr. Verghese. “In so many ways, we find ourselves powerless,” she said.

Protesting, Dr. Verghese added, was “one tiny moment where I got to regain my sense of agency, that I could actually do something about this.”

This article first appeared on Medscape.com.

The American Psychiatric Association (APA) is calling on Congress to permanently lift restrictions that have allowed unfettered delivery of telehealth services during the COVID-19 pandemic, which experts say has been a boon to patients and physicians alike.

“We ask Congress to extend the telehealth waiver authority under COVID-19 beyond the emergency and to study its impact while doing so,” said APA President Jeffrey Geller, MD, in a May 27 video briefing with congressional staff and reporters.

The APA is also seeking to make permanent certain waivers granted by the Centers for Medicare & Medicaid Services on April 30, including elimination of geographic restrictions on behavioral health and allowing patients be seen at home, said Dr. Geller.

The APA also is asking for the elimination of the rule that requires clinicians to have an initial face-to-face meeting with patients before they can prescribe controlled substances, Dr. Geller said. The Drug Enforcement Administration waived that requirement, known as the Ryan Haight Act, on March 17 for the duration of the national emergency.

Telemedicine has supporters on both sides of the aisle in Congress, including Rep. Paul Tonko (D-N.Y.) who said at the APA briefing he would fight to make the waivers permanent.

“The expanded use of telehealth has enormous potential during normal times as well, especially in behavioral health,” said Mr. Tonko. “I am pushing fiercely for these current flexibilities to be extended for a reasonable time after the public health emergency so that we can have time to evaluate which should be made permanent,” he said.

Dr. Geller, other clinicians, and advocates in the briefing praised CMS for facilitating telepsychiatry for Medicare. That follows in the footsteps of most private insurers, who have also relaxed requirements into the summer, according to the Medical Group Management Association.
 

Game changer

The Medicare waivers “have dramatically changed the entire scene for someone like myself as a clinician to allow me to see my patients in a much easier way,” said Peter Yellowlees, MBBS, MD, chief wellness officer, University of California Davis Health. Within 2 weeks in March, the health system converted almost all of its regular outpatient visits to telemedicine, he said.

Dr. Yellowlees added government still needs to address, what he called, outdated HIPAA regulations that ban certain technologies.

“It makes no sense that I can talk to someone on an iPhone, but the moment I talk to them on FaceTime, it’s illegal,” said Dr. Yellowlees, a former president of the American Telemedicine Association.

Dr. Geller said that “psychiatric care provided by telehealth is as effective as in-person psychiatric services,” adding that “some patients prefer telepsychiatry because of its convenience and as a means of reducing stigma associated with seeking help for mental health.”

Shabana Khan, MD, a child psychiatrist and director of telepsychiatry at New York University Langone Health, said audio and video conferencing are helping address a shortage and maldistribution of child and adolescent psychiatrists.

Americans’ mental health is suffering during the pandemic. The U.S. Census Bureau recently released data showing that half of those surveyed reported depressed mood and that one-third are reporting anxiety, depression, or both, as reported by the Washington Post.

“At this very time that anxiety, depression, substance use, and other mental health problems are rising, our nation’s already strained mental health system is really being pushed to the brink,” said Jodi Kwarciany, manager for mental health policy for the National Alliance on Mental Illness, during the briefing.

Telemedicine can help “by connecting people to providers at the time and the place and using the technology that works best for them,” she said, adding that NAMI would press policymakers to address barriers to access.

The clinicians on the briefing said they’ve observed that some patients are more comfortable with video or audio interactions than with in-person visits.
 

Increased access to care

Telepsychiatry seems to be convincing some to reconsider therapy, since they can do it at home, said Dr. Yellowlees. The technology is a way of “enlarging the tent for us as a profession and providing more care,” he said.

For instance, he said, he has been able to consult by phone and video with several patients who receive care through the Indian Health Service who had not be able to get into the physical clinic.

Dr. Yellowlees said video sessions also may encourage patients to be more, not less, talkative. “Video is actually counterintuitively a very intimate experience,” he said, in part because of the perceived distance and people’s tendency to be less inhibited on technology platforms.“It’s less embarrassing,” he said. “If you’ve got really dramatic, difficult, traumatic things to talk about, it’s slightly easier to talk to someone who’s slightly further apart from you on video,” said Dr. Yellowlees.

“Individuals who have a significant amount of anxiety may actually feel more comfortable with the distance that this technology affords,” agreed Dr. Khan. She said telemedicine had made sessions more comfortable for some of her patients with autism spectrum disorder.

Dr. Geller said audio and video have been important to his practice during the pandemic. One of his patients never leaves the house and does not use computers. “He spends his time sequestered at home listening to records on his record player,” said Dr. Geller. But he’s been amenable to phone sessions. “What I’ve found with him, and I’ve found with several other patients, is that they actually talk more easily when they’re not face to face,” he said.
 

Far fewer no-shows

Another plus for his New England–based practice during the last few months: patients have not been anxious about missing sessions because of the weather. The clinicians all noted that telepsychiatry seemed to reduce missed visits.

Dr. Yellowlees said that no-show rates had decreased by half at UC Davis. “That means no significant loss of income,” during the pandemic, he said.

“The no-show rate is incredibly low, particularly because when you call the patients and they don’t remember they had an appointment, you have the appointment anyway, most of the time,” said Dr. Geller.

For Dr. Khan, being able to conduct audio and video sessions during the pandemic has meant keeping up continuity of care.

As a result of the pandemic, many college students in New York City had to go home – often to another state. The waivers granted by New York’s Medicaid program and other insurers have allowed Dr. Khan to continue care for these patients.

The NYU clinic also operates day programs in rural areas 5 hours from the city. Dr. Khan recently evaluated a 12-year-old girl with significant anxiety and low mood, both of which had worsened.

“She would not have been able to access care otherwise,” said Dr. Khan. And for rural patients who do not have access to broadband or smartphones, audio visits “have been immensely helpful,” she said.

Dr. Khan, Dr. Geller, and Dr. Yellowlees have disclosed no relevant financial relationships.

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

The American Psychiatric Association (APA) is calling on Congress to permanently lift restrictions that have allowed unfettered delivery of telehealth services during the COVID-19 pandemic, which experts say has been a boon to patients and physicians alike.

“We ask Congress to extend the telehealth waiver authority under COVID-19 beyond the emergency and to study its impact while doing so,” said APA President Jeffrey Geller, MD, in a May 27 video briefing with congressional staff and reporters.

The APA is also seeking to make permanent certain waivers granted by the Centers for Medicare & Medicaid Services on April 30, including elimination of geographic restrictions on behavioral health and allowing patients be seen at home, said Dr. Geller.

The APA also is asking for the elimination of the rule that requires clinicians to have an initial face-to-face meeting with patients before they can prescribe controlled substances, Dr. Geller said. The Drug Enforcement Administration waived that requirement, known as the Ryan Haight Act, on March 17 for the duration of the national emergency.

Telemedicine has supporters on both sides of the aisle in Congress, including Rep. Paul Tonko (D-N.Y.) who said at the APA briefing he would fight to make the waivers permanent.

“The expanded use of telehealth has enormous potential during normal times as well, especially in behavioral health,” said Mr. Tonko. “I am pushing fiercely for these current flexibilities to be extended for a reasonable time after the public health emergency so that we can have time to evaluate which should be made permanent,” he said.

Dr. Geller, other clinicians, and advocates in the briefing praised CMS for facilitating telepsychiatry for Medicare. That follows in the footsteps of most private insurers, who have also relaxed requirements into the summer, according to the Medical Group Management Association.
 

Game changer

The Medicare waivers “have dramatically changed the entire scene for someone like myself as a clinician to allow me to see my patients in a much easier way,” said Peter Yellowlees, MBBS, MD, chief wellness officer, University of California Davis Health. Within 2 weeks in March, the health system converted almost all of its regular outpatient visits to telemedicine, he said.

Dr. Yellowlees added government still needs to address, what he called, outdated HIPAA regulations that ban certain technologies.

“It makes no sense that I can talk to someone on an iPhone, but the moment I talk to them on FaceTime, it’s illegal,” said Dr. Yellowlees, a former president of the American Telemedicine Association.

Dr. Geller said that “psychiatric care provided by telehealth is as effective as in-person psychiatric services,” adding that “some patients prefer telepsychiatry because of its convenience and as a means of reducing stigma associated with seeking help for mental health.”

Shabana Khan, MD, a child psychiatrist and director of telepsychiatry at New York University Langone Health, said audio and video conferencing are helping address a shortage and maldistribution of child and adolescent psychiatrists.

Americans’ mental health is suffering during the pandemic. The U.S. Census Bureau recently released data showing that half of those surveyed reported depressed mood and that one-third are reporting anxiety, depression, or both, as reported by the Washington Post.

“At this very time that anxiety, depression, substance use, and other mental health problems are rising, our nation’s already strained mental health system is really being pushed to the brink,” said Jodi Kwarciany, manager for mental health policy for the National Alliance on Mental Illness, during the briefing.

Telemedicine can help “by connecting people to providers at the time and the place and using the technology that works best for them,” she said, adding that NAMI would press policymakers to address barriers to access.

The clinicians on the briefing said they’ve observed that some patients are more comfortable with video or audio interactions than with in-person visits.
 

Increased access to care

Telepsychiatry seems to be convincing some to reconsider therapy, since they can do it at home, said Dr. Yellowlees. The technology is a way of “enlarging the tent for us as a profession and providing more care,” he said.

For instance, he said, he has been able to consult by phone and video with several patients who receive care through the Indian Health Service who had not be able to get into the physical clinic.

Dr. Yellowlees said video sessions also may encourage patients to be more, not less, talkative. “Video is actually counterintuitively a very intimate experience,” he said, in part because of the perceived distance and people’s tendency to be less inhibited on technology platforms.“It’s less embarrassing,” he said. “If you’ve got really dramatic, difficult, traumatic things to talk about, it’s slightly easier to talk to someone who’s slightly further apart from you on video,” said Dr. Yellowlees.

“Individuals who have a significant amount of anxiety may actually feel more comfortable with the distance that this technology affords,” agreed Dr. Khan. She said telemedicine had made sessions more comfortable for some of her patients with autism spectrum disorder.

Dr. Geller said audio and video have been important to his practice during the pandemic. One of his patients never leaves the house and does not use computers. “He spends his time sequestered at home listening to records on his record player,” said Dr. Geller. But he’s been amenable to phone sessions. “What I’ve found with him, and I’ve found with several other patients, is that they actually talk more easily when they’re not face to face,” he said.
 

Far fewer no-shows

Another plus for his New England–based practice during the last few months: patients have not been anxious about missing sessions because of the weather. The clinicians all noted that telepsychiatry seemed to reduce missed visits.

Dr. Yellowlees said that no-show rates had decreased by half at UC Davis. “That means no significant loss of income,” during the pandemic, he said.

“The no-show rate is incredibly low, particularly because when you call the patients and they don’t remember they had an appointment, you have the appointment anyway, most of the time,” said Dr. Geller.

For Dr. Khan, being able to conduct audio and video sessions during the pandemic has meant keeping up continuity of care.

As a result of the pandemic, many college students in New York City had to go home – often to another state. The waivers granted by New York’s Medicaid program and other insurers have allowed Dr. Khan to continue care for these patients.

The NYU clinic also operates day programs in rural areas 5 hours from the city. Dr. Khan recently evaluated a 12-year-old girl with significant anxiety and low mood, both of which had worsened.

“She would not have been able to access care otherwise,” said Dr. Khan. And for rural patients who do not have access to broadband or smartphones, audio visits “have been immensely helpful,” she said.

Dr. Khan, Dr. Geller, and Dr. Yellowlees have disclosed no relevant financial relationships.

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

The American Psychiatric Association (APA) is calling on Congress to permanently lift restrictions that have allowed unfettered delivery of telehealth services during the COVID-19 pandemic, which experts say has been a boon to patients and physicians alike.

“We ask Congress to extend the telehealth waiver authority under COVID-19 beyond the emergency and to study its impact while doing so,” said APA President Jeffrey Geller, MD, in a May 27 video briefing with congressional staff and reporters.

The APA is also seeking to make permanent certain waivers granted by the Centers for Medicare & Medicaid Services on April 30, including elimination of geographic restrictions on behavioral health and allowing patients be seen at home, said Dr. Geller.

The APA also is asking for the elimination of the rule that requires clinicians to have an initial face-to-face meeting with patients before they can prescribe controlled substances, Dr. Geller said. The Drug Enforcement Administration waived that requirement, known as the Ryan Haight Act, on March 17 for the duration of the national emergency.

Telemedicine has supporters on both sides of the aisle in Congress, including Rep. Paul Tonko (D-N.Y.) who said at the APA briefing he would fight to make the waivers permanent.

“The expanded use of telehealth has enormous potential during normal times as well, especially in behavioral health,” said Mr. Tonko. “I am pushing fiercely for these current flexibilities to be extended for a reasonable time after the public health emergency so that we can have time to evaluate which should be made permanent,” he said.

Dr. Geller, other clinicians, and advocates in the briefing praised CMS for facilitating telepsychiatry for Medicare. That follows in the footsteps of most private insurers, who have also relaxed requirements into the summer, according to the Medical Group Management Association.
 

Game changer

The Medicare waivers “have dramatically changed the entire scene for someone like myself as a clinician to allow me to see my patients in a much easier way,” said Peter Yellowlees, MBBS, MD, chief wellness officer, University of California Davis Health. Within 2 weeks in March, the health system converted almost all of its regular outpatient visits to telemedicine, he said.

Dr. Yellowlees added government still needs to address, what he called, outdated HIPAA regulations that ban certain technologies.

“It makes no sense that I can talk to someone on an iPhone, but the moment I talk to them on FaceTime, it’s illegal,” said Dr. Yellowlees, a former president of the American Telemedicine Association.

Dr. Geller said that “psychiatric care provided by telehealth is as effective as in-person psychiatric services,” adding that “some patients prefer telepsychiatry because of its convenience and as a means of reducing stigma associated with seeking help for mental health.”

Shabana Khan, MD, a child psychiatrist and director of telepsychiatry at New York University Langone Health, said audio and video conferencing are helping address a shortage and maldistribution of child and adolescent psychiatrists.

Americans’ mental health is suffering during the pandemic. The U.S. Census Bureau recently released data showing that half of those surveyed reported depressed mood and that one-third are reporting anxiety, depression, or both, as reported by the Washington Post.

“At this very time that anxiety, depression, substance use, and other mental health problems are rising, our nation’s already strained mental health system is really being pushed to the brink,” said Jodi Kwarciany, manager for mental health policy for the National Alliance on Mental Illness, during the briefing.

Telemedicine can help “by connecting people to providers at the time and the place and using the technology that works best for them,” she said, adding that NAMI would press policymakers to address barriers to access.

The clinicians on the briefing said they’ve observed that some patients are more comfortable with video or audio interactions than with in-person visits.
 

Increased access to care

Telepsychiatry seems to be convincing some to reconsider therapy, since they can do it at home, said Dr. Yellowlees. The technology is a way of “enlarging the tent for us as a profession and providing more care,” he said.

For instance, he said, he has been able to consult by phone and video with several patients who receive care through the Indian Health Service who had not be able to get into the physical clinic.

Dr. Yellowlees said video sessions also may encourage patients to be more, not less, talkative. “Video is actually counterintuitively a very intimate experience,” he said, in part because of the perceived distance and people’s tendency to be less inhibited on technology platforms.“It’s less embarrassing,” he said. “If you’ve got really dramatic, difficult, traumatic things to talk about, it’s slightly easier to talk to someone who’s slightly further apart from you on video,” said Dr. Yellowlees.

“Individuals who have a significant amount of anxiety may actually feel more comfortable with the distance that this technology affords,” agreed Dr. Khan. She said telemedicine had made sessions more comfortable for some of her patients with autism spectrum disorder.

Dr. Geller said audio and video have been important to his practice during the pandemic. One of his patients never leaves the house and does not use computers. “He spends his time sequestered at home listening to records on his record player,” said Dr. Geller. But he’s been amenable to phone sessions. “What I’ve found with him, and I’ve found with several other patients, is that they actually talk more easily when they’re not face to face,” he said.
 

Far fewer no-shows

Another plus for his New England–based practice during the last few months: patients have not been anxious about missing sessions because of the weather. The clinicians all noted that telepsychiatry seemed to reduce missed visits.

Dr. Yellowlees said that no-show rates had decreased by half at UC Davis. “That means no significant loss of income,” during the pandemic, he said.

“The no-show rate is incredibly low, particularly because when you call the patients and they don’t remember they had an appointment, you have the appointment anyway, most of the time,” said Dr. Geller.

For Dr. Khan, being able to conduct audio and video sessions during the pandemic has meant keeping up continuity of care.

As a result of the pandemic, many college students in New York City had to go home – often to another state. The waivers granted by New York’s Medicaid program and other insurers have allowed Dr. Khan to continue care for these patients.

The NYU clinic also operates day programs in rural areas 5 hours from the city. Dr. Khan recently evaluated a 12-year-old girl with significant anxiety and low mood, both of which had worsened.

“She would not have been able to access care otherwise,” said Dr. Khan. And for rural patients who do not have access to broadband or smartphones, audio visits “have been immensely helpful,” she said.

Dr. Khan, Dr. Geller, and Dr. Yellowlees have disclosed no relevant financial relationships.

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

On March 31, soon after the Food and Drug Administration authorized emergency use of antibody-packed plasma from recovered patients with COVID-19, Marisa Leuzzi became the first donor at an American Red Cross center. She hoped it could help her aunt, Renee Bannister, who was failing after 3 weeks on a ventilator at Virtua Hospital in Voorhees, N.J.

It may have worked; 11 days after receiving the plasma, Ms. Bannister was weaned off the ventilator and she is now awake and speaking, said Red Cross spokesperson Stephanie Rendon.

This kind of anecdote is fueling demand for the therapy, which can be provided through an expanded access program led by the Mayo Clinic, backed by the FDA, and the plasma paid for by the U.S. Department of Health & Human Services. But while this program is collecting safety and outcomes data, it’s not a randomized, controlled trial.

Others, however, are pursuing that data. At least a dozen researchers are investigating the potential of plasma – both as a treatment and whether it could act as a stand-in for a vaccine until one is developed.

“One of the things I don’t want this to be is the flavor of the month,” Shmuel Shoham, MD, associate professor of medicine at Johns Hopkins University, said in an interview.

Dr. Shoham, principal investigator for a study evaluating convalescent plasma to prevent the infection in high-risk individuals, said some clinicians, desperate for any treatment, have tried potential therapies such as hydroxychloroquine and remdesivir without evidence of safety or efficacy in COVID-19.

The National Institutes of Health recently said something similar for convalescent plasma, that “there are insufficient clinical data to recommend either for or against” its use for COVID-19.

But plasma has promise, according to a Johns Hopkins School of Medicine’s Bloomberg Distinguished Professor, Arturo Casadevall, MD, PhD, in Baltimore, and Liise-anne Pirofski, MD, a professor at Albert Einstein College of Medicine, New York. They lay out the case for convalescent plasma in an article published online March 13 in the Journal of Clinical Investigation. Passive antibody therapy, they wrote, has been used to stem polio, measles, mumps, and influenza, and more recently has shown some success against SARS-CoV-1 and Middle East respiratory syndrome (MERS).

“The special attraction of this modality of treatment is that, unlike vaccines or newly developed drugs, it could, in principle, be made available very rapidly,” said researchers with the National COVID-19 Convalescent Plasma Project, which includes physicians and scientists from 57 institutions in 46 states. But where principle veers from reality is in availability of the plasma itself, and donors are in short supply.
 

Aiming to prevent infection

So far, the FDA has approved 12 plasma trials – including Dr. Shoham’s – and the NIH’s clinicaltrials.gov lists more than two dozen convalescent plasma studies in the United States and elsewhere.

Most are single-arm trials to determine if one infusion can decrease the need for intubation or help those on a ventilator improve. Two others, one at Johns Hopkins and one at Stanford (Calif.) Hospital are investigating whether convalescent plasma might be used before severe disease sets in.

“A general principle of passive antibody therapy is that it is more effective when used for prophylaxis than for treatment of disease,” Dr. Casadevall and Dr. Pirofski wrote.

Stanford’s randomized, double-blind study will evaluate regular versus convalescent plasma in ED patients who are not sick enough to require hospitalization.

The Johns Hopkins trial, which aims to protect against infection in the first place, will begin at Johns Hopkins, Baltimore, and at Hopkins-affiliated hospitals throughout Maryland, Dr. Shoham said. He hopes it will expand nationwide eventually, and said that they expect to enroll the first patients soon.

To start, the prevention study will enroll only 150 patients, each of whom must have had close contact with someone who has COVID-19 within the previous 120 hours and be asymptomatic. The number of subjects is small, compared with the trial size of other potential therapies, and an issue, Shoham said, “that keeps me up at night.” But finding thousands of enrollees for plasma studies is hard, in part because it’s so difficult to recruit donors.

Participants will receive normal plasma (which will act as a placebo) or convalescent plasma.

The primary endpoint is cumulative incidence of COVID-19, defined as symptoms and a polymerase chain reaction–positive test; participants will be tracked for 90 days. Hospitals and health care workers could then decide if they want to use the therapy, he said.

The study will not answer whether participants will continue to have antibodies beyond the 90 days. Convalescent plasma is given as a rapid response to an emergent pathogen – a short-term boost of immunity rather than a long-term therapeutic.
 

What can we learn from expanded access?

Meanwhile, some 2,200 hospitals are participating in the expanded access program being led by the Mayo Clinic nationwide; more than 9,000 patients had received infusions at press time.

One participant is Northwell Health, a 23-hospital system that sprawls across the U.S. COVID epicenter: four of the five boroughs of New York City and Long Island.

Convalescent plasma is an in-demand therapy, said Christina Brennan, MD, vice president of clinical research at Northwell. “We get patients, family members, they say my family member is at X hospital – if it’s not being offered there, can you have them transferred?” she said in an interview.

When Northwell – through the New York Blood Bank – opened up donor registration, 800 people signed up in the first 24 hours, Dr. Brennan said. As of mid-May, 527 patients had received a transfusion.
 

Who’s the best donor and when should donation occur?

The Red Cross, hospitals, and independent blood banks are all soliciting donors, who can sign up at the Red Cross website. The FDA recommends that donors have a history of COVID-19 as confirmed by molecular or antibody testing, be symptom free for 14 days, have a negative follow-up molecular test, and be virus free at the time of collection. The FDA also suggests measuring a donor’s SARS-CoV-2 neutralizing antibody titers, if available, with a recommendation of at least 1:160.

But questions remain, such as whether there is a theoretical risk for antibody-dependent enhancement (ADE) of infection with SARS-CoV-2. “Antibodies to one type of coronavirus could enhance infection to another viral strain,” of coronavirus, Dr. Casadevall wrote. ADE has been observed in both severe acute respiratory syndrome (SARS) and MERS.

The other risk is that donors may still be shedding active virus. While the FDA suggests that donors are unlikely to still be infectious 14 days after infection, that is as of yet unproven. Both COVID-19 diagnostics and antibody tests have high rates of false negatives, which raises the specter that infection could be spread via the plasma donation.

Daniele Focosi, MD, PhD, from Pisa (Italy) University Hospital and colleagues raise that concern in a preprint review on convalescent plasma in COVID-19. “Although the recipient is already infected, theoretically transmission of more infectious particles could worsen clinical conditions,” they wrote, noting that “such a concern can be somewhat reduced by treatment with modern pathogen inactivation techniques.”

No evidence exists that SARS-CoV-2 can be transmitted through blood, but “we don’t know for sure,” Dr. Shoham said in an interview. A reassuring point: Even those with severe infection do not have viral RNA in their blood, he said, adding, “We don’t think there’s going to be viral transmission of this particular virus with transfusion.”

For another highly infectious pathogen, the Ebola virus, the World Health Organization recommended in 2014 that potential plasma donors wait at least 28 days after infection.

It’s also not known how long SARS-CoV-2 antibodies persist in the blood; longer viability could mean a longer donation window. Dr. Focosi noted that a previous Chinese study had shown that SARS-specific antibodies in people infected with the first SARS virus, SARS-CoV-1, persisted for 2 years.

Dr. Casadevall and Dr. Pirofski have disclosed no relevant financial relationships. Shoham has disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

On March 31, soon after the Food and Drug Administration authorized emergency use of antibody-packed plasma from recovered patients with COVID-19, Marisa Leuzzi became the first donor at an American Red Cross center. She hoped it could help her aunt, Renee Bannister, who was failing after 3 weeks on a ventilator at Virtua Hospital in Voorhees, N.J.

It may have worked; 11 days after receiving the plasma, Ms. Bannister was weaned off the ventilator and she is now awake and speaking, said Red Cross spokesperson Stephanie Rendon.

This kind of anecdote is fueling demand for the therapy, which can be provided through an expanded access program led by the Mayo Clinic, backed by the FDA, and the plasma paid for by the U.S. Department of Health & Human Services. But while this program is collecting safety and outcomes data, it’s not a randomized, controlled trial.

Others, however, are pursuing that data. At least a dozen researchers are investigating the potential of plasma – both as a treatment and whether it could act as a stand-in for a vaccine until one is developed.

“One of the things I don’t want this to be is the flavor of the month,” Shmuel Shoham, MD, associate professor of medicine at Johns Hopkins University, said in an interview.

Dr. Shoham, principal investigator for a study evaluating convalescent plasma to prevent the infection in high-risk individuals, said some clinicians, desperate for any treatment, have tried potential therapies such as hydroxychloroquine and remdesivir without evidence of safety or efficacy in COVID-19.

The National Institutes of Health recently said something similar for convalescent plasma, that “there are insufficient clinical data to recommend either for or against” its use for COVID-19.

But plasma has promise, according to a Johns Hopkins School of Medicine’s Bloomberg Distinguished Professor, Arturo Casadevall, MD, PhD, in Baltimore, and Liise-anne Pirofski, MD, a professor at Albert Einstein College of Medicine, New York. They lay out the case for convalescent plasma in an article published online March 13 in the Journal of Clinical Investigation. Passive antibody therapy, they wrote, has been used to stem polio, measles, mumps, and influenza, and more recently has shown some success against SARS-CoV-1 and Middle East respiratory syndrome (MERS).

“The special attraction of this modality of treatment is that, unlike vaccines or newly developed drugs, it could, in principle, be made available very rapidly,” said researchers with the National COVID-19 Convalescent Plasma Project, which includes physicians and scientists from 57 institutions in 46 states. But where principle veers from reality is in availability of the plasma itself, and donors are in short supply.
 

Aiming to prevent infection

So far, the FDA has approved 12 plasma trials – including Dr. Shoham’s – and the NIH’s clinicaltrials.gov lists more than two dozen convalescent plasma studies in the United States and elsewhere.

Most are single-arm trials to determine if one infusion can decrease the need for intubation or help those on a ventilator improve. Two others, one at Johns Hopkins and one at Stanford (Calif.) Hospital are investigating whether convalescent plasma might be used before severe disease sets in.

“A general principle of passive antibody therapy is that it is more effective when used for prophylaxis than for treatment of disease,” Dr. Casadevall and Dr. Pirofski wrote.

Stanford’s randomized, double-blind study will evaluate regular versus convalescent plasma in ED patients who are not sick enough to require hospitalization.

The Johns Hopkins trial, which aims to protect against infection in the first place, will begin at Johns Hopkins, Baltimore, and at Hopkins-affiliated hospitals throughout Maryland, Dr. Shoham said. He hopes it will expand nationwide eventually, and said that they expect to enroll the first patients soon.

To start, the prevention study will enroll only 150 patients, each of whom must have had close contact with someone who has COVID-19 within the previous 120 hours and be asymptomatic. The number of subjects is small, compared with the trial size of other potential therapies, and an issue, Shoham said, “that keeps me up at night.” But finding thousands of enrollees for plasma studies is hard, in part because it’s so difficult to recruit donors.

Participants will receive normal plasma (which will act as a placebo) or convalescent plasma.

The primary endpoint is cumulative incidence of COVID-19, defined as symptoms and a polymerase chain reaction–positive test; participants will be tracked for 90 days. Hospitals and health care workers could then decide if they want to use the therapy, he said.

The study will not answer whether participants will continue to have antibodies beyond the 90 days. Convalescent plasma is given as a rapid response to an emergent pathogen – a short-term boost of immunity rather than a long-term therapeutic.
 

What can we learn from expanded access?

Meanwhile, some 2,200 hospitals are participating in the expanded access program being led by the Mayo Clinic nationwide; more than 9,000 patients had received infusions at press time.

One participant is Northwell Health, a 23-hospital system that sprawls across the U.S. COVID epicenter: four of the five boroughs of New York City and Long Island.

Convalescent plasma is an in-demand therapy, said Christina Brennan, MD, vice president of clinical research at Northwell. “We get patients, family members, they say my family member is at X hospital – if it’s not being offered there, can you have them transferred?” she said in an interview.

When Northwell – through the New York Blood Bank – opened up donor registration, 800 people signed up in the first 24 hours, Dr. Brennan said. As of mid-May, 527 patients had received a transfusion.
 

Who’s the best donor and when should donation occur?

The Red Cross, hospitals, and independent blood banks are all soliciting donors, who can sign up at the Red Cross website. The FDA recommends that donors have a history of COVID-19 as confirmed by molecular or antibody testing, be symptom free for 14 days, have a negative follow-up molecular test, and be virus free at the time of collection. The FDA also suggests measuring a donor’s SARS-CoV-2 neutralizing antibody titers, if available, with a recommendation of at least 1:160.

But questions remain, such as whether there is a theoretical risk for antibody-dependent enhancement (ADE) of infection with SARS-CoV-2. “Antibodies to one type of coronavirus could enhance infection to another viral strain,” of coronavirus, Dr. Casadevall wrote. ADE has been observed in both severe acute respiratory syndrome (SARS) and MERS.

The other risk is that donors may still be shedding active virus. While the FDA suggests that donors are unlikely to still be infectious 14 days after infection, that is as of yet unproven. Both COVID-19 diagnostics and antibody tests have high rates of false negatives, which raises the specter that infection could be spread via the plasma donation.

Daniele Focosi, MD, PhD, from Pisa (Italy) University Hospital and colleagues raise that concern in a preprint review on convalescent plasma in COVID-19. “Although the recipient is already infected, theoretically transmission of more infectious particles could worsen clinical conditions,” they wrote, noting that “such a concern can be somewhat reduced by treatment with modern pathogen inactivation techniques.”

No evidence exists that SARS-CoV-2 can be transmitted through blood, but “we don’t know for sure,” Dr. Shoham said in an interview. A reassuring point: Even those with severe infection do not have viral RNA in their blood, he said, adding, “We don’t think there’s going to be viral transmission of this particular virus with transfusion.”

For another highly infectious pathogen, the Ebola virus, the World Health Organization recommended in 2014 that potential plasma donors wait at least 28 days after infection.

It’s also not known how long SARS-CoV-2 antibodies persist in the blood; longer viability could mean a longer donation window. Dr. Focosi noted that a previous Chinese study had shown that SARS-specific antibodies in people infected with the first SARS virus, SARS-CoV-1, persisted for 2 years.

Dr. Casadevall and Dr. Pirofski have disclosed no relevant financial relationships. Shoham has disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

On March 31, soon after the Food and Drug Administration authorized emergency use of antibody-packed plasma from recovered patients with COVID-19, Marisa Leuzzi became the first donor at an American Red Cross center. She hoped it could help her aunt, Renee Bannister, who was failing after 3 weeks on a ventilator at Virtua Hospital in Voorhees, N.J.

It may have worked; 11 days after receiving the plasma, Ms. Bannister was weaned off the ventilator and she is now awake and speaking, said Red Cross spokesperson Stephanie Rendon.

This kind of anecdote is fueling demand for the therapy, which can be provided through an expanded access program led by the Mayo Clinic, backed by the FDA, and the plasma paid for by the U.S. Department of Health & Human Services. But while this program is collecting safety and outcomes data, it’s not a randomized, controlled trial.

Others, however, are pursuing that data. At least a dozen researchers are investigating the potential of plasma – both as a treatment and whether it could act as a stand-in for a vaccine until one is developed.

“One of the things I don’t want this to be is the flavor of the month,” Shmuel Shoham, MD, associate professor of medicine at Johns Hopkins University, said in an interview.

Dr. Shoham, principal investigator for a study evaluating convalescent plasma to prevent the infection in high-risk individuals, said some clinicians, desperate for any treatment, have tried potential therapies such as hydroxychloroquine and remdesivir without evidence of safety or efficacy in COVID-19.

The National Institutes of Health recently said something similar for convalescent plasma, that “there are insufficient clinical data to recommend either for or against” its use for COVID-19.

But plasma has promise, according to a Johns Hopkins School of Medicine’s Bloomberg Distinguished Professor, Arturo Casadevall, MD, PhD, in Baltimore, and Liise-anne Pirofski, MD, a professor at Albert Einstein College of Medicine, New York. They lay out the case for convalescent plasma in an article published online March 13 in the Journal of Clinical Investigation. Passive antibody therapy, they wrote, has been used to stem polio, measles, mumps, and influenza, and more recently has shown some success against SARS-CoV-1 and Middle East respiratory syndrome (MERS).

“The special attraction of this modality of treatment is that, unlike vaccines or newly developed drugs, it could, in principle, be made available very rapidly,” said researchers with the National COVID-19 Convalescent Plasma Project, which includes physicians and scientists from 57 institutions in 46 states. But where principle veers from reality is in availability of the plasma itself, and donors are in short supply.
 

Aiming to prevent infection

So far, the FDA has approved 12 plasma trials – including Dr. Shoham’s – and the NIH’s clinicaltrials.gov lists more than two dozen convalescent plasma studies in the United States and elsewhere.

Most are single-arm trials to determine if one infusion can decrease the need for intubation or help those on a ventilator improve. Two others, one at Johns Hopkins and one at Stanford (Calif.) Hospital are investigating whether convalescent plasma might be used before severe disease sets in.

“A general principle of passive antibody therapy is that it is more effective when used for prophylaxis than for treatment of disease,” Dr. Casadevall and Dr. Pirofski wrote.

Stanford’s randomized, double-blind study will evaluate regular versus convalescent plasma in ED patients who are not sick enough to require hospitalization.

The Johns Hopkins trial, which aims to protect against infection in the first place, will begin at Johns Hopkins, Baltimore, and at Hopkins-affiliated hospitals throughout Maryland, Dr. Shoham said. He hopes it will expand nationwide eventually, and said that they expect to enroll the first patients soon.

To start, the prevention study will enroll only 150 patients, each of whom must have had close contact with someone who has COVID-19 within the previous 120 hours and be asymptomatic. The number of subjects is small, compared with the trial size of other potential therapies, and an issue, Shoham said, “that keeps me up at night.” But finding thousands of enrollees for plasma studies is hard, in part because it’s so difficult to recruit donors.

Participants will receive normal plasma (which will act as a placebo) or convalescent plasma.

The primary endpoint is cumulative incidence of COVID-19, defined as symptoms and a polymerase chain reaction–positive test; participants will be tracked for 90 days. Hospitals and health care workers could then decide if they want to use the therapy, he said.

The study will not answer whether participants will continue to have antibodies beyond the 90 days. Convalescent plasma is given as a rapid response to an emergent pathogen – a short-term boost of immunity rather than a long-term therapeutic.
 

What can we learn from expanded access?

Meanwhile, some 2,200 hospitals are participating in the expanded access program being led by the Mayo Clinic nationwide; more than 9,000 patients had received infusions at press time.

One participant is Northwell Health, a 23-hospital system that sprawls across the U.S. COVID epicenter: four of the five boroughs of New York City and Long Island.

Convalescent plasma is an in-demand therapy, said Christina Brennan, MD, vice president of clinical research at Northwell. “We get patients, family members, they say my family member is at X hospital – if it’s not being offered there, can you have them transferred?” she said in an interview.

When Northwell – through the New York Blood Bank – opened up donor registration, 800 people signed up in the first 24 hours, Dr. Brennan said. As of mid-May, 527 patients had received a transfusion.
 

Who’s the best donor and when should donation occur?

The Red Cross, hospitals, and independent blood banks are all soliciting donors, who can sign up at the Red Cross website. The FDA recommends that donors have a history of COVID-19 as confirmed by molecular or antibody testing, be symptom free for 14 days, have a negative follow-up molecular test, and be virus free at the time of collection. The FDA also suggests measuring a donor’s SARS-CoV-2 neutralizing antibody titers, if available, with a recommendation of at least 1:160.

But questions remain, such as whether there is a theoretical risk for antibody-dependent enhancement (ADE) of infection with SARS-CoV-2. “Antibodies to one type of coronavirus could enhance infection to another viral strain,” of coronavirus, Dr. Casadevall wrote. ADE has been observed in both severe acute respiratory syndrome (SARS) and MERS.

The other risk is that donors may still be shedding active virus. While the FDA suggests that donors are unlikely to still be infectious 14 days after infection, that is as of yet unproven. Both COVID-19 diagnostics and antibody tests have high rates of false negatives, which raises the specter that infection could be spread via the plasma donation.

Daniele Focosi, MD, PhD, from Pisa (Italy) University Hospital and colleagues raise that concern in a preprint review on convalescent plasma in COVID-19. “Although the recipient is already infected, theoretically transmission of more infectious particles could worsen clinical conditions,” they wrote, noting that “such a concern can be somewhat reduced by treatment with modern pathogen inactivation techniques.”

No evidence exists that SARS-CoV-2 can be transmitted through blood, but “we don’t know for sure,” Dr. Shoham said in an interview. A reassuring point: Even those with severe infection do not have viral RNA in their blood, he said, adding, “We don’t think there’s going to be viral transmission of this particular virus with transfusion.”

For another highly infectious pathogen, the Ebola virus, the World Health Organization recommended in 2014 that potential plasma donors wait at least 28 days after infection.

It’s also not known how long SARS-CoV-2 antibodies persist in the blood; longer viability could mean a longer donation window. Dr. Focosi noted that a previous Chinese study had shown that SARS-specific antibodies in people infected with the first SARS virus, SARS-CoV-1, persisted for 2 years.

Dr. Casadevall and Dr. Pirofski have disclosed no relevant financial relationships. Shoham has disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

A handful of specialties – including family medicine, obstetrics/gynecology, pediatrics, and other primary care specialties – are calling for targeted and urgent relief payments from the federal government, saying that they have been left out of distributions aimed at alleviating the financial fallout associated with the novel coronavirus.

The federal government has already distributed about $150 billion – through direct payments and advances on reimbursement – to clinicians, but, to date, the money has only been given to providers who bill Medicare, and not even all of those individuals have received payments.

“It is critical that frontline physicians who may not participate in Medicare fee-for-service, in whole or in part, including obstetrician/gynecologists, pediatricians, and family physicians, have the resources they need to continue providing essential health care to patients amid the pandemic and in the months to come,” said the American Academy of Family Physicians, the American Academy of Pediatrics, and the American College of Obstetricians and Gynecologists in a letter to Health & Human Services (Secretary Alex Azar.

In particular, the organizations are concerned that no money has been distributed or earmarked for clinicians who serve Medicaid recipients.

“The organizations that signed that letter are the primary providers of care to the Medicaid population,” Shawn Martin, senior VP for the AAFP, said in an interview. That’s true even for family physicians.

“Typically, in an average family medicine practice, their Medicaid panel size is equal to if not greater than the Medicare panel size,” he said.

On April 23, Mr. Azar said HHS was working on a distribution plan for providers who only take Medicaid, as well as for dentists and skilled nursing facilities. An HHS spokesperson confirmed that the agency still intends to provide money to those groups of providers and that the agency is committed to distributing funds quickly and with transparency.

Mr. Azar had also announced that the government would soon start distributing $20 billion in payments to Medicare providers, on top of the $30 billion that had already been handed out to clinicians on April 10 and 17.

That $50 billion came from the COVID-19–related $100 billion Provider Relief Fund, which was part of the Coronavirus Aid, Relief, and Economic Security Act, signed into law on March 27.

Additionally, the Centers for Medicare & Medicaid Services had distributed some $100 billion to providers who participated in Medicare Part A or B through the Medicare Advance Payment program, which is a deferred loan. The agency brought that program to a halt on April 27.

An additional $75 billion will now be available through the Public Health and Social Services Emergency Fund (PHSSEF) as part of the third congressional COVID relief package, signed into law on April 24.

Mr. Martin said that the AAFP and other physician organizations have been talking with HHS about how to distribute money from that new pool of funds. “There’s been a lot of progress, but there hasn’t been any action,” he said, adding that the purpose of the joint letter to HHS “is to say it’s time for action.”
 

COVID-19 damage

AAFP, AAP, and ACOG noted in the letter the damage that’s being inflicted by COVID-19. They cited data that show a 50% decline in measles, mumps, and rubella shots, a 42% drop in diphtheria and whooping cough vaccinations, and a 73% decline in human papillomavirus shots. The groups also noted a rise in child abuse injuries that are being seen in EDs and the potential for a worsening of the maternal mortality crisis in the United States.

Primary care physicians are also the go-to doctors for upper respiratory infections, noted the groups in the letter.

“Put simply, our physician members need to be able to keep their doors open and continue treating patients,” said the groups.

A study by Harvard University and Phreesia, a health care technology company, found that ambulatory practice visits had declined by at least half since early February, with a 71% drop in visits by 7- to 17-year-olds and a 59% decline in visits by neonates, infants, and toddlers (up to age 6). Overall, pediatric practices experienced a 62% drop-off in visits.

Research conducted by the Physicians Foundation and Merritt Hawkins shows that 21% of 842 physicians who responded to an early April survey said they’d been furloughed or been given a pay cut. That number rose to 30% among doctors who are not treating COVID-19 patients.

Although the majority in the survey (66%) said they planned to keep practicing in the same manner during the pandemic, 32% said they planned to change practices, opt out of patient care roles, close their practices temporarily, or retire. The survey has a margin of error of ±3.5%.
 

Internists seek consideration, too

The American College of Physicians also has urged HHS to give special consideration to its members. The group wrote to Mr. Azar on April 28, recommending that payments from the new $75 billion PHSSEF be prioritized for primary care, as well as for smaller practices, those that provide care in underserved areas, and internal medicine subspecialty practices.

“Internal medicine specialists and other primary care physicians have an essential role in delivering primary, preventive, and comprehensive care not only to patients with symptoms or diagnoses of COVID-19, but also to patients with other underlying medical conditions, including conditions like heart disease and diabetes that put them at greater risk of mortality from COVID-19,” wrote ACP President Jacqueline Fincher, MD, MACP.

ACP said the government could pay physicians on the basis of the amount of additional expenses incurred that were related to COVID-19, such as extra staffing or temporary relocation of their place of residence to prevent exposing family members to the virus. Pay should also be based on the percentage of revenue losses from all payers, including Medicare, Medicaid, and commercial insurers, Dr. Fincher said in the letter.

AAFP, AAP, and ACOG also had a suggestion for distributing payments to non-Medicare providers. “Given that most women’s health, pediatric, and family practices have received less financial relief to date, we recommend that HHS provide these practices with a larger proportion of funds relative to their reported revenue than is provided on average across specialties,” they wrote.

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

A handful of specialties – including family medicine, obstetrics/gynecology, pediatrics, and other primary care specialties – are calling for targeted and urgent relief payments from the federal government, saying that they have been left out of distributions aimed at alleviating the financial fallout associated with the novel coronavirus.

The federal government has already distributed about $150 billion – through direct payments and advances on reimbursement – to clinicians, but, to date, the money has only been given to providers who bill Medicare, and not even all of those individuals have received payments.

“It is critical that frontline physicians who may not participate in Medicare fee-for-service, in whole or in part, including obstetrician/gynecologists, pediatricians, and family physicians, have the resources they need to continue providing essential health care to patients amid the pandemic and in the months to come,” said the American Academy of Family Physicians, the American Academy of Pediatrics, and the American College of Obstetricians and Gynecologists in a letter to Health & Human Services (Secretary Alex Azar.

In particular, the organizations are concerned that no money has been distributed or earmarked for clinicians who serve Medicaid recipients.

“The organizations that signed that letter are the primary providers of care to the Medicaid population,” Shawn Martin, senior VP for the AAFP, said in an interview. That’s true even for family physicians.

“Typically, in an average family medicine practice, their Medicaid panel size is equal to if not greater than the Medicare panel size,” he said.

On April 23, Mr. Azar said HHS was working on a distribution plan for providers who only take Medicaid, as well as for dentists and skilled nursing facilities. An HHS spokesperson confirmed that the agency still intends to provide money to those groups of providers and that the agency is committed to distributing funds quickly and with transparency.

Mr. Azar had also announced that the government would soon start distributing $20 billion in payments to Medicare providers, on top of the $30 billion that had already been handed out to clinicians on April 10 and 17.

That $50 billion came from the COVID-19–related $100 billion Provider Relief Fund, which was part of the Coronavirus Aid, Relief, and Economic Security Act, signed into law on March 27.

Additionally, the Centers for Medicare & Medicaid Services had distributed some $100 billion to providers who participated in Medicare Part A or B through the Medicare Advance Payment program, which is a deferred loan. The agency brought that program to a halt on April 27.

An additional $75 billion will now be available through the Public Health and Social Services Emergency Fund (PHSSEF) as part of the third congressional COVID relief package, signed into law on April 24.

Mr. Martin said that the AAFP and other physician organizations have been talking with HHS about how to distribute money from that new pool of funds. “There’s been a lot of progress, but there hasn’t been any action,” he said, adding that the purpose of the joint letter to HHS “is to say it’s time for action.”
 

COVID-19 damage

AAFP, AAP, and ACOG noted in the letter the damage that’s being inflicted by COVID-19. They cited data that show a 50% decline in measles, mumps, and rubella shots, a 42% drop in diphtheria and whooping cough vaccinations, and a 73% decline in human papillomavirus shots. The groups also noted a rise in child abuse injuries that are being seen in EDs and the potential for a worsening of the maternal mortality crisis in the United States.

Primary care physicians are also the go-to doctors for upper respiratory infections, noted the groups in the letter.

“Put simply, our physician members need to be able to keep their doors open and continue treating patients,” said the groups.

A study by Harvard University and Phreesia, a health care technology company, found that ambulatory practice visits had declined by at least half since early February, with a 71% drop in visits by 7- to 17-year-olds and a 59% decline in visits by neonates, infants, and toddlers (up to age 6). Overall, pediatric practices experienced a 62% drop-off in visits.

Research conducted by the Physicians Foundation and Merritt Hawkins shows that 21% of 842 physicians who responded to an early April survey said they’d been furloughed or been given a pay cut. That number rose to 30% among doctors who are not treating COVID-19 patients.

Although the majority in the survey (66%) said they planned to keep practicing in the same manner during the pandemic, 32% said they planned to change practices, opt out of patient care roles, close their practices temporarily, or retire. The survey has a margin of error of ±3.5%.
 

Internists seek consideration, too

The American College of Physicians also has urged HHS to give special consideration to its members. The group wrote to Mr. Azar on April 28, recommending that payments from the new $75 billion PHSSEF be prioritized for primary care, as well as for smaller practices, those that provide care in underserved areas, and internal medicine subspecialty practices.

“Internal medicine specialists and other primary care physicians have an essential role in delivering primary, preventive, and comprehensive care not only to patients with symptoms or diagnoses of COVID-19, but also to patients with other underlying medical conditions, including conditions like heart disease and diabetes that put them at greater risk of mortality from COVID-19,” wrote ACP President Jacqueline Fincher, MD, MACP.

ACP said the government could pay physicians on the basis of the amount of additional expenses incurred that were related to COVID-19, such as extra staffing or temporary relocation of their place of residence to prevent exposing family members to the virus. Pay should also be based on the percentage of revenue losses from all payers, including Medicare, Medicaid, and commercial insurers, Dr. Fincher said in the letter.

AAFP, AAP, and ACOG also had a suggestion for distributing payments to non-Medicare providers. “Given that most women’s health, pediatric, and family practices have received less financial relief to date, we recommend that HHS provide these practices with a larger proportion of funds relative to their reported revenue than is provided on average across specialties,” they wrote.

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

A handful of specialties – including family medicine, obstetrics/gynecology, pediatrics, and other primary care specialties – are calling for targeted and urgent relief payments from the federal government, saying that they have been left out of distributions aimed at alleviating the financial fallout associated with the novel coronavirus.

The federal government has already distributed about $150 billion – through direct payments and advances on reimbursement – to clinicians, but, to date, the money has only been given to providers who bill Medicare, and not even all of those individuals have received payments.

“It is critical that frontline physicians who may not participate in Medicare fee-for-service, in whole or in part, including obstetrician/gynecologists, pediatricians, and family physicians, have the resources they need to continue providing essential health care to patients amid the pandemic and in the months to come,” said the American Academy of Family Physicians, the American Academy of Pediatrics, and the American College of Obstetricians and Gynecologists in a letter to Health & Human Services (Secretary Alex Azar.

In particular, the organizations are concerned that no money has been distributed or earmarked for clinicians who serve Medicaid recipients.

“The organizations that signed that letter are the primary providers of care to the Medicaid population,” Shawn Martin, senior VP for the AAFP, said in an interview. That’s true even for family physicians.

“Typically, in an average family medicine practice, their Medicaid panel size is equal to if not greater than the Medicare panel size,” he said.

On April 23, Mr. Azar said HHS was working on a distribution plan for providers who only take Medicaid, as well as for dentists and skilled nursing facilities. An HHS spokesperson confirmed that the agency still intends to provide money to those groups of providers and that the agency is committed to distributing funds quickly and with transparency.

Mr. Azar had also announced that the government would soon start distributing $20 billion in payments to Medicare providers, on top of the $30 billion that had already been handed out to clinicians on April 10 and 17.

That $50 billion came from the COVID-19–related $100 billion Provider Relief Fund, which was part of the Coronavirus Aid, Relief, and Economic Security Act, signed into law on March 27.

Additionally, the Centers for Medicare & Medicaid Services had distributed some $100 billion to providers who participated in Medicare Part A or B through the Medicare Advance Payment program, which is a deferred loan. The agency brought that program to a halt on April 27.

An additional $75 billion will now be available through the Public Health and Social Services Emergency Fund (PHSSEF) as part of the third congressional COVID relief package, signed into law on April 24.

Mr. Martin said that the AAFP and other physician organizations have been talking with HHS about how to distribute money from that new pool of funds. “There’s been a lot of progress, but there hasn’t been any action,” he said, adding that the purpose of the joint letter to HHS “is to say it’s time for action.”
 

COVID-19 damage

AAFP, AAP, and ACOG noted in the letter the damage that’s being inflicted by COVID-19. They cited data that show a 50% decline in measles, mumps, and rubella shots, a 42% drop in diphtheria and whooping cough vaccinations, and a 73% decline in human papillomavirus shots. The groups also noted a rise in child abuse injuries that are being seen in EDs and the potential for a worsening of the maternal mortality crisis in the United States.

Primary care physicians are also the go-to doctors for upper respiratory infections, noted the groups in the letter.

“Put simply, our physician members need to be able to keep their doors open and continue treating patients,” said the groups.

A study by Harvard University and Phreesia, a health care technology company, found that ambulatory practice visits had declined by at least half since early February, with a 71% drop in visits by 7- to 17-year-olds and a 59% decline in visits by neonates, infants, and toddlers (up to age 6). Overall, pediatric practices experienced a 62% drop-off in visits.

Research conducted by the Physicians Foundation and Merritt Hawkins shows that 21% of 842 physicians who responded to an early April survey said they’d been furloughed or been given a pay cut. That number rose to 30% among doctors who are not treating COVID-19 patients.

Although the majority in the survey (66%) said they planned to keep practicing in the same manner during the pandemic, 32% said they planned to change practices, opt out of patient care roles, close their practices temporarily, or retire. The survey has a margin of error of ±3.5%.
 

Internists seek consideration, too

The American College of Physicians also has urged HHS to give special consideration to its members. The group wrote to Mr. Azar on April 28, recommending that payments from the new $75 billion PHSSEF be prioritized for primary care, as well as for smaller practices, those that provide care in underserved areas, and internal medicine subspecialty practices.

“Internal medicine specialists and other primary care physicians have an essential role in delivering primary, preventive, and comprehensive care not only to patients with symptoms or diagnoses of COVID-19, but also to patients with other underlying medical conditions, including conditions like heart disease and diabetes that put them at greater risk of mortality from COVID-19,” wrote ACP President Jacqueline Fincher, MD, MACP.

ACP said the government could pay physicians on the basis of the amount of additional expenses incurred that were related to COVID-19, such as extra staffing or temporary relocation of their place of residence to prevent exposing family members to the virus. Pay should also be based on the percentage of revenue losses from all payers, including Medicare, Medicaid, and commercial insurers, Dr. Fincher said in the letter.

AAFP, AAP, and ACOG also had a suggestion for distributing payments to non-Medicare providers. “Given that most women’s health, pediatric, and family practices have received less financial relief to date, we recommend that HHS provide these practices with a larger proportion of funds relative to their reported revenue than is provided on average across specialties,” they wrote.

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

There has been a massive decline in outpatient office visits as patients have stayed home – likely deferring needed care – because of COVID-19, new research shows.

The number of visits to ambulatory practices dropped by a whopping 60% in mid-March, and continues to be down by at least 50% since early February, according to new data compiled and analyzed by Harvard University and Phreesia, a health care technology company.

Phreesia – which helps medical practices with patient registration, insurance verification, and payments – has data on 50,000 providers in all 50 states; in a typical year, Phreesia tracks 50 million outpatient visits.

The report was published online April 23 by the Commonwealth Fund.

The company captured data on visits from February 1 through April 16. The decline was greatest in New England and the Mid-Atlantic states, where, at the steepest end of the decline in late March, visits were down 66%.

They have rebounded slightly since then but are still down 64%. Practices in the mountain states had the smallest decline, but visits were down by 45% as of April 16.

Many practices have attempted to reach out to patients through telemedicine. As of April 16, about 30% of all visits tracked by Phreesia were provided via telemedicine – by phone or through video. That’s a monumental increase from mid-February, when zero visits were conducted virtually.

However, the Harvard researchers found that telemedicine visits barely made up for the huge decline in office visits.
 

Decline by specialty

Not surprisingly, declining visits have been steeper in procedure-oriented specialties.

Overall visits – including telemedicine – to ophthalmologists and otolaryngologists had declined by 79% and 75%, respectively, as of the week of April 5. Dermatology saw a 73% decline. Surgery, pulmonology, urology, orthopedics, cardiology, and gastroenterology all experienced declines ranging from 61% to 66%.

Primary care offices, oncology, endocrinology, and obstetrics/gynecology all fared slightly better, with visits down by half. Behavioral health experienced the lowest rate of decline (30%).

School-aged children were skipping care most often. The study showed a 71% drop in visits in 7- to 17-year-olds, and a 59% decline in visits by neonates, infants, and toddlers (up to age 6). Overall, pediatric practices experienced a 62% drop-off in visits.

Nearly two-thirds of Americans over age 65 also stayed away from their doctors. Only half of those aged 18 to 64 reduced their physician visits.

This article first appeared on Medscape.com.

There has been a massive decline in outpatient office visits as patients have stayed home – likely deferring needed care – because of COVID-19, new research shows.

The number of visits to ambulatory practices dropped by a whopping 60% in mid-March, and continues to be down by at least 50% since early February, according to new data compiled and analyzed by Harvard University and Phreesia, a health care technology company.

Phreesia – which helps medical practices with patient registration, insurance verification, and payments – has data on 50,000 providers in all 50 states; in a typical year, Phreesia tracks 50 million outpatient visits.

The report was published online April 23 by the Commonwealth Fund.

The company captured data on visits from February 1 through April 16. The decline was greatest in New England and the Mid-Atlantic states, where, at the steepest end of the decline in late March, visits were down 66%.

They have rebounded slightly since then but are still down 64%. Practices in the mountain states had the smallest decline, but visits were down by 45% as of April 16.

Many practices have attempted to reach out to patients through telemedicine. As of April 16, about 30% of all visits tracked by Phreesia were provided via telemedicine – by phone or through video. That’s a monumental increase from mid-February, when zero visits were conducted virtually.

However, the Harvard researchers found that telemedicine visits barely made up for the huge decline in office visits.
 

Decline by specialty

Not surprisingly, declining visits have been steeper in procedure-oriented specialties.

Overall visits – including telemedicine – to ophthalmologists and otolaryngologists had declined by 79% and 75%, respectively, as of the week of April 5. Dermatology saw a 73% decline. Surgery, pulmonology, urology, orthopedics, cardiology, and gastroenterology all experienced declines ranging from 61% to 66%.

Primary care offices, oncology, endocrinology, and obstetrics/gynecology all fared slightly better, with visits down by half. Behavioral health experienced the lowest rate of decline (30%).

School-aged children were skipping care most often. The study showed a 71% drop in visits in 7- to 17-year-olds, and a 59% decline in visits by neonates, infants, and toddlers (up to age 6). Overall, pediatric practices experienced a 62% drop-off in visits.

Nearly two-thirds of Americans over age 65 also stayed away from their doctors. Only half of those aged 18 to 64 reduced their physician visits.

This article first appeared on Medscape.com.

There has been a massive decline in outpatient office visits as patients have stayed home – likely deferring needed care – because of COVID-19, new research shows.

The number of visits to ambulatory practices dropped by a whopping 60% in mid-March, and continues to be down by at least 50% since early February, according to new data compiled and analyzed by Harvard University and Phreesia, a health care technology company.

Phreesia – which helps medical practices with patient registration, insurance verification, and payments – has data on 50,000 providers in all 50 states; in a typical year, Phreesia tracks 50 million outpatient visits.

The report was published online April 23 by the Commonwealth Fund.

The company captured data on visits from February 1 through April 16. The decline was greatest in New England and the Mid-Atlantic states, where, at the steepest end of the decline in late March, visits were down 66%.

They have rebounded slightly since then but are still down 64%. Practices in the mountain states had the smallest decline, but visits were down by 45% as of April 16.

Many practices have attempted to reach out to patients through telemedicine. As of April 16, about 30% of all visits tracked by Phreesia were provided via telemedicine – by phone or through video. That’s a monumental increase from mid-February, when zero visits were conducted virtually.

However, the Harvard researchers found that telemedicine visits barely made up for the huge decline in office visits.
 

Decline by specialty

Not surprisingly, declining visits have been steeper in procedure-oriented specialties.

Overall visits – including telemedicine – to ophthalmologists and otolaryngologists had declined by 79% and 75%, respectively, as of the week of April 5. Dermatology saw a 73% decline. Surgery, pulmonology, urology, orthopedics, cardiology, and gastroenterology all experienced declines ranging from 61% to 66%.

Primary care offices, oncology, endocrinology, and obstetrics/gynecology all fared slightly better, with visits down by half. Behavioral health experienced the lowest rate of decline (30%).

School-aged children were skipping care most often. The study showed a 71% drop in visits in 7- to 17-year-olds, and a 59% decline in visits by neonates, infants, and toddlers (up to age 6). Overall, pediatric practices experienced a 62% drop-off in visits.

Nearly two-thirds of Americans over age 65 also stayed away from their doctors. Only half of those aged 18 to 64 reduced their physician visits.

This article first appeared on Medscape.com.

The dermatologist had been in practice just a few years when he was approached by a private equity group. This was around 2015, when dermatology was just starting to buzz about investor buyouts. He was curious, so he agreed to meet with the company.

“They approached me with the idea that they could help me grow my practice, help my patients, and cut down overhead,” said the northern Alabama dermatologist, who asked that his name not be used. Over a lavish dinner, the investors lauded the clinician for his business acumen and for having built a great practice so quickly. They made an enticing buyout offer.

Ja_inter/DigitalVision Vectors

Salvation or death sentence?

Depending on whom you ask, the continuing growth of private equity purchases of dermatology practices is either the death – or salvation – of the specialty.

Many dermatologists question whether the financial backers will invest in quality of care, or if they just will hire mid-level providers to churn out procedures to plump up revenues.

Neither the controversy nor the acquisitions show any sign of abating.

The American Academy of Dermatology has hosted debates on the topic at its annual meetings – and was to do so in 2020 until COVID-19 led to the meeting’s cancellation. AAD has not weighed in with any official policy and is not releasing data it may be collecting on the potential impact of private equity ownership. The organization provided a statement from President George J. Hruza, MD, who said, “the AAD supports a member’s right to choose the model that works best for them,” adding that the Academy “expects its members to provide safe and effective patient care, regardless of a dermatologist’s practice setting.” Dr. Hruza sold his Chesterfield, Mo., practice to United Skin Specialists, a private equity–backed company, in 2016, and still works at the same practice.

Some have said the acquisitions need to stop. “Until meaningful data are available on what happens to the quality of care and affordability for patients and payers, dermatologists should stop selling their practices to private equity firms, and legislators should prohibit such transactions,” wrote Joshua M. Sharfstein, MD, and Jamar Slocum, MD, of the Johns Hopkins Bloomberg School of Public Health, Baltimore, in an editorial in July (JAMA Dermatol. 2019;155[9]:1007-8).

Although he acknowledged that he has not tracked the issue closely and that little data exist on the impact on quality or cost, Dr. Sharfstein has not changed his tune. “I think there are enough warning signs to say we should put the brakes on,” he said in an interview.

“For what reason?” asked Betsy Wernli, MD, president of Forefront Dermatology, an investor-owned group based in Manitowoc, Wis. She said it seems that “on this topic, we abandon our scientific foundations and default to emotion and anecdote,” she said in an interview. “Having capital, and an investor that supports us has allowed us to perform better patient care,” she said. Dermatologist variance across all practices and practice models should be cause for more concern, she added.

Sailesh Konda, MD, has been an outspoken critic. Dr. Konda, medical director and clinical assistant professor in the department of dermatology at the University of Florida, Gainesville, and colleagues detailed the complicated financial machinations of private equity in the Journal of the American Academy of Dermatology. They showed that private investors seemed to hone in on buying outlier practices that performed high numbers of procedures. The paper – first made public in the fall of 2018 – created an uproar, especially among private equity companies. It was initially removed from the website in conjunction with a request from the editor that its conclusions be altered to be less harsh on private equity, according to the New York Times. The paper was eventually published in 2019 (J Am Acad Dermatol. Jul;81[1]:287-296.e8).

Dr. Konda has spoken at various dermatology forums and health care gatherings on private equity. He told the Times that he had given 16 talks to health care groups in 2018, and he was due to speak to a health care investors’ group in 2020. But he would not comment on the record for this story.

Brett Coldiron, MD, a former president of the AAD, also has been critical. He believes investor-owners push for more biopsies, freezing of actinic keratoses, Moh’s surgery, and other well-paying procedures. “I’m convinced that private equity may be the undoing of our specialty,” Dr. Coldiron said in an interview.

In a paper titled, “Private Equity Acquisition of Physician Practices,” published in the Annals of Internal Medicine in January 2019, Lawrence Casalino, MD, PhD, chief of the division of health policy and economics at New York’s Weill Cornell Medicine, and colleagues wrote that “private equity firms focus on specialties with high potential for additional income from elective procedures and ancillary services,” and that “dermatology has been a major focus” (Ann Intern Med. 2019;170[2]:114-5).

And in a viewpoint published in JAMA in February 2019, first-year medical student Suhas Gondi and Zirui Song, MD, PhD, both of Harvard Medical School, Boston, concluded that investor-owned practices could drive up overall health spending in part because they extract better reimbursement from insurers (JAMA. 2019;321[11]:1047-8).

Access could also become an issue if the companies drive smaller independent practices out of business, they wrote.

On the other hand, they said, “these investments may also benefit patients and bring more efficiency to a system burdened with waste.” The authors called for more research and “thoughtful regulation” to enhance the potential positives while mitigating the negatives.

So far, the acquisitions have largely escaped the notice of regulators or lawmakers. Congress has made noises about targeting specialty practices owned by private equity as a means of taming surprise medical bills, but that legislation has been stymied.

Dr. Coldiron is convinced that private investors will eventually be tripped up by state laws that prohibit the corporate practice of medicine.

Leslie Baumann, MD, who sold her Miami practice in October 2019 to the investor-owned Skin and Cancer Associates, said critics are too cynical. “What if these private equity firms are going to actually make our specialty better?” she asked in an interview.

What makes dermatology attractive?

Private equity has been acquiring specialty practices since at least 2009, with an acceleration over the last 5 years. Dermatology has been a frequent target, in part because so many dermatologists were in independent or small group private practices, making them ripe for takeover.

A 2015 report on the specialty by Cegedim, a company that provides information technology support to health care, found that the majority of practices had fewer than five physicians and that 57% of the practices were independent.

But more dermatologists are choosing employment. In a 2018 Medscape survey, 57% of dermatologists reported they were employed, while 49% were self-employed.

During 2013-2016, investors bought 35 dermatology practices – comprising 334 physicians, according to one study published in February (JAMA. 2020;323[7]:663-5). Investors bought 69 anesthesiology practices, 43 emergency medicine practices, and 39 family medicine practices during the same period.

Harvard’s Mr. Gondi and Dr. Song estimated that dermatology practices accounted for 15% of investor purchases in 2015 and 2016, even though dermatologists make up just 1% of U.S. clinicians.

In another paper published in JAMA Dermatology, Sally Tan, MD, and colleagues at Brigham and Women’s Hospital, Boston, and Harvard medical and business schools, estimated that, in 2019, at least 184 practices, comprising 381 clinics, were owned by 17 private equity groups and that the acquisitions had been accelerating: from 5 in 2012 to 59 in 2017 to 34 in the first 5 months of 2018 (JAMA Dermatol. 2019;155[9]:1013-21).

“It’s a very attractive area for investors because they know that the future is bright for dermatology,” said Reuven Porges, MD, CEO of Ft. Lauderdale-based Skin and Cancer Associates, which is owned by a private investor. Because dermatology involves providing many ancillary services and cash-only cosmetic services, “it has tremendous potential to continue to be successful in the future regardless of what health care changes are coming,” Dr. Porges said in an interview.

Investors also see promise in dermatology in the United States because “there’s a huge supply demand mismatch,” said Vance Vanier, MD, a cofounding managing partner at Chicago Pacific Founders, the private equity owner of Pinnacle Dermatology, which has 52 locations in Illinois, Indiana, Michigan, Minnesota, and Tennessee.

Theoretically, when investors handle billing, insurance negotiations, and health information technology, it gives clinicians more time to practice, Dr. Vanier said in an interview.

“Once that doctor is freed up to not do administrative tasks and focus on patient care, then, if they want to, they can see more patients and be more responsive to their needs,” he said.

Dr. Vanier said investor acquisitions are here to stay. “This is a trend that could go on for another 50 years before any saturation point is hit,” he said. “It’s a $2 trillion market. It’s hard to wrap your head around how enormous health care services is,” he said.

Dermatology acquisitions will be driven by the continuing imbalance of physician supply and patient demand; the financial pressure on newly graduating physicians who have big debt loads; the requirements for investment in health information technology to report quality metrics; and an aging population, Dr. Vanier said.

In a JAMA Dermatology viewpoint, Jack Resneck Jr., MD, professor of dermatology, University of California, San Francisco, listed many of the same factors – plus a skin cancer epidemic – as fueling dermatology acquisitions (JAMA Dermatol. 2018;154[1]:13-4).

Medical practices – not just dermatology practices – also offer a pure financial play. “Acquisitions of smaller practices provide a major arbitrage opportunity,” Dr. Casalino and colleagues said in the January 2019 Annals of Internal Medicine paper. In a merger of smaller practices into larger, the smaller practice’s valuation immediately becomes that of the bigger one, they wrote.
 

Could the bottom fall out?

Creating giant groups through consolidation is a main aim for private equity.

Skin and Cancer Associates, founded in 1971, was a large entity, with 25 practices. But for a long time, its leaders had wanted to become a regional or a national player, said Dr. Porges. Those leaders asked Dr. Porges – who helped take his former radiology practice through a private equity purchase – to help them attract investors. In March 2018, Susquehanna Private Capital signed on as a “partner” with Skin and Cancer Associates.

It has since almost doubled in size, with 40 locations and 60 dermatologists, all in Florida, Dr. Porges said. “The only limiting factor for growing it as fast as we want, is really money,” he said.

Consolidation is just an initial step. Most investors have a finite timeline for cashing out. “The ultimate goal is often to realize a profitable secondary sale in three to seven years to another PE investor (or even a publicly traded entity),” Dr. Resneck wrote in the 2018 JAMA Dermatology paper.

Not all private equity companies are the same, said Dr. Wernli, of Forefront. Dermatologists can investigate a company’s “hold period” – how long they keep an investment before trading – and the strength of its capitalization before deciding to sell, she said.

Since 2016, Forefront has been owned by the Ontario Municipal Employee Retirement System (OMERS), a pension fund for the province’s public workers. OMERS bought Forefront from Varsity Healthcare Partners, which had owned the dermatology group for just 2 years.

Dr. Wernli said OMERS is a good, solid investor. “They have unlimited resources to invest so they don’t have to quickly flip a company to satisfy an investment in another company,” she said.

Some investor-backed dermatology practices have gone belly up. In 2012, WestWind Investors bought DermOne, based in Toms River, N.J. But by early 2018, the business had fallen apart, and some practices – in North Carolina, New Jersey, Texas, and Virginia – just shut their doors.

Long Island City, N.Y.–based Schweiger Dermatology Group, backed by private equity, snapped up nine of the New Jersey DermOne practices in March 2018.

Another private equity–backed company, U.S. Dermatology Partners, defaulted on a $377 million loan in January 2020. As reported by Bloomberg, the company had $340 million in revenue in 2018. U.S. Dermatology’s owners are reportedly working out a recapitalization or debt-for-equity swap with the lenders.

Dr. Wernli said that financial problems aren’t unique to investor-owned practices and that doctors could still be out of a job if a private practice goes under.

“A private practice can also default on their loans that they’ve used to fund their own personal practice, leaving employed physicians in the same situation,” she said.

Patients are likely to be in the dark, however, until the doors close.

Pressure on practices

Private equity is changing the shape of practice for both those who work for investor-owned businesses and those still out on their own.

The Alabama dermatologist, for instance, said it has made it harder for him to recruit new doctors, who are offered big signing bonuses and a steady income by the investor-owned practices. “They’re skewing the numbers,” he said, adding that residents are now expecting a big payment and benefits.

Dr. Baumann said that when she was on her own, she had trouble finding and recruiting good dermatologists. But it has become easier since she’d sold to Skin and Cancer Associates, she said, noting that Dr. Porges recently found a qualified candidate for her to interview a week after she put in a request.

Another dermatologist in a Midwestern metropolitan practice – who did not want his name used – said that when it came time for him to increase his equity stake, his older partner, who was near retirement and had explored selling to private equity – wanted four-and-a-half times the price that had been discussed when he joined the practice.

The younger partner believes the private equity offers inflated the practice’s valuation in his partner’s mind. He ended up leaving the practice.

Many dermatologists have been led to believe that their practices are worth more than they might be, according to Dr. Coldiron. “I think a lot of these doctors that sell out are deluded. They think that they’re getting a lot of money and they’re not,” he said.

Typically, investors may offer three or four times earnings before interest, taxes, depreciation and amortization (EBITDA). The money paid out is taxed at the capital gains rate, which provides some savings. “But you have to pay that all back, because when they sign you up, you become an employee,” Dr. Coldiron said.

Doctors often agree to work for 5 years, but during that period, their base salary is decreased while the buyout cash is meted out to them, he added. A chunk of the buyout usually is also given as equity, but that equity is worthless unless the investor sells to another entity.

Pinnacle Dermatology doesn’t want doctors to retire immediately upon an acquisition, said Dr. Vanier of Chicago Pacific Founders. “We want to find physician partners who want to keep working,” he said. “We strongly believe if you don’t have strong physician leadership, experienced physician leadership, that your odds of success go down.”

Chicago Pacific also believes physicians should have an ownership interest, he said. It allows them to share in the eventual financial rewards – whether that’s 5 or 20 years later, said Dr. Vanier.

Dr. Coldiron sees other pressures that skew practice styles and can harm patient care. Clinicians in investor-owned practices are often urged to refer all dermatopathology to labs owned by the practice and often, a Moh’s surgeon is employed to service all the practices – sometimes even being flown in from elsewhere, he claimed.

That takes away the clinician’s autonomy in terms of referring where he or she feels appropriate and also could harm pathologists and Moh’s surgeons that depend on those referral streams, he added.

In their paper, Mr. Gondi and Dr. Song wrote that this practice is concerning because “keeping referrals within the practice may render referral patterns less responsive to patient needs or preference.”
 

Procedure factories?

Many critics say investor-backed practices are goosing revenues by hiring more mid-level providers – such as nurse practitioners and physician assistants – and getting them to perform more procedures.

Midlevel practitioners do more biopsies than dermatologists do to get a diagnosis, according to Dr. Coldiron.

A 2018 JAMA Dermatology study appears to back that up. Physician assistants needed to conduct 3.9 biopsies to diagnose one skin cancer, compared to 3.3 for dermatologists. For a single melanoma, the number needed to biopsy was 39.4 for PAs and 25.4 for dermatologists (JAMA Dermatol. 2018;154[5]:569-73).

Skin biopsies have almost doubled in the last decade, said Dr. Coldiron. “The skin cancer epidemic would account for only half of that,” he said.

“The ultimate loser is the patient – because the patient doesn’t get the highest quality care and the patient has unnecessary things done to him or her,” he said. But, he said, he could not directly tie the biopsy increase to the rise of private equity.

Forefront tracks the number of biopsies per patient done by every dermatologist in its network – to make sure that no one is outside the norms set by the Centers for Medicare and Medicaid Services, said Dr. Wernli. And she said biopsies declined after the group was bought by private equity.

Dr. Baumann said the average number of biopsies per patient at Skin and Cancer Associates in 2019 was 0.20 – less than the 0.30 average reported by Medicare that same year.

The rising use of mid-level providers existed long before private equity came on the scene, said Dr. Wernli. “There’s not enough board-certified dermatologists to satisfy need,” she said, noting that, in addition, many clinicians won’t serve rural areas. “If we don’t move and extend ourselves, there will be someone who fills our shoes,” she said, adding that Forefront has 1 mid-level for every 1.5 to 2 dermatologists.

Skin and Cancer Associates has 55 doctors and 29 physician assistants, said Dr. Baumann, adding that she had not been pressured to add any mid-level providers to her practice.
 

Excitement about sale shot down

Dr. Wernli and Dr. Baumann both have been happy with their decision to ally with private equity. For Dr. Baumann, however, her move was tinged by online attacks that reflected the strong opinions on the topic.

She began looking into selling her practice when one of her businesses – Skin Type Solutions – began taking off. Both her clinical practice and research business were thriving. She had two children at home and was having a hard time keeping up with the administrative end of her businesses.

None of her partners nor any groups in Miami showed interest in purchasing the practice, so she began researching private equity. She spoke with seven companies before settling on Skin and Cancer Associates. They had “a long track record of successfully running practices,” said Dr. Baumann, adding that “the doctors who work there are happy, and I respect the quality of the physicians and the organization.”

When she closed the deal in October 2019, she agreed to stay on for 5 years and signed a noncompete clause that she deems “very reasonable.” Among the perks she cites: being able to consult via telemedicine with an expert on pigmented lesions; quick and easy referrals to a Moh’s surgeon; being able to train residents; and having paid personal time off.

It’s less responsibility and the same or better job satisfaction, she said.

But when she shared the news on a private Facebook group for board-certified dermatologists, she was vilified. Of some 195 comments, about half were “mean,” said Dr. Baumann.

“I was shocked about how strongly everybody feels,” she said. Those commenting accused her of doing it for the money or said that her move was contributing to the ruination of dermatology.

“I just defended myself,” she said. “For me, it was my time.”

Dr. Coldiron and Dr. Baumann are members of the Dermatology News editorial advisory board.

The dermatologist had been in practice just a few years when he was approached by a private equity group. This was around 2015, when dermatology was just starting to buzz about investor buyouts. He was curious, so he agreed to meet with the company.

“They approached me with the idea that they could help me grow my practice, help my patients, and cut down overhead,” said the northern Alabama dermatologist, who asked that his name not be used. Over a lavish dinner, the investors lauded the clinician for his business acumen and for having built a great practice so quickly. They made an enticing buyout offer.

Ja_inter/DigitalVision Vectors

Salvation or death sentence?

Depending on whom you ask, the continuing growth of private equity purchases of dermatology practices is either the death – or salvation – of the specialty.

Many dermatologists question whether the financial backers will invest in quality of care, or if they just will hire mid-level providers to churn out procedures to plump up revenues.

Neither the controversy nor the acquisitions show any sign of abating.

The American Academy of Dermatology has hosted debates on the topic at its annual meetings – and was to do so in 2020 until COVID-19 led to the meeting’s cancellation. AAD has not weighed in with any official policy and is not releasing data it may be collecting on the potential impact of private equity ownership. The organization provided a statement from President George J. Hruza, MD, who said, “the AAD supports a member’s right to choose the model that works best for them,” adding that the Academy “expects its members to provide safe and effective patient care, regardless of a dermatologist’s practice setting.” Dr. Hruza sold his Chesterfield, Mo., practice to United Skin Specialists, a private equity–backed company, in 2016, and still works at the same practice.

Some have said the acquisitions need to stop. “Until meaningful data are available on what happens to the quality of care and affordability for patients and payers, dermatologists should stop selling their practices to private equity firms, and legislators should prohibit such transactions,” wrote Joshua M. Sharfstein, MD, and Jamar Slocum, MD, of the Johns Hopkins Bloomberg School of Public Health, Baltimore, in an editorial in July (JAMA Dermatol. 2019;155[9]:1007-8).

Although he acknowledged that he has not tracked the issue closely and that little data exist on the impact on quality or cost, Dr. Sharfstein has not changed his tune. “I think there are enough warning signs to say we should put the brakes on,” he said in an interview.

“For what reason?” asked Betsy Wernli, MD, president of Forefront Dermatology, an investor-owned group based in Manitowoc, Wis. She said it seems that “on this topic, we abandon our scientific foundations and default to emotion and anecdote,” she said in an interview. “Having capital, and an investor that supports us has allowed us to perform better patient care,” she said. Dermatologist variance across all practices and practice models should be cause for more concern, she added.

Sailesh Konda, MD, has been an outspoken critic. Dr. Konda, medical director and clinical assistant professor in the department of dermatology at the University of Florida, Gainesville, and colleagues detailed the complicated financial machinations of private equity in the Journal of the American Academy of Dermatology. They showed that private investors seemed to hone in on buying outlier practices that performed high numbers of procedures. The paper – first made public in the fall of 2018 – created an uproar, especially among private equity companies. It was initially removed from the website in conjunction with a request from the editor that its conclusions be altered to be less harsh on private equity, according to the New York Times. The paper was eventually published in 2019 (J Am Acad Dermatol. Jul;81[1]:287-296.e8).

Dr. Konda has spoken at various dermatology forums and health care gatherings on private equity. He told the Times that he had given 16 talks to health care groups in 2018, and he was due to speak to a health care investors’ group in 2020. But he would not comment on the record for this story.

Brett Coldiron, MD, a former president of the AAD, also has been critical. He believes investor-owners push for more biopsies, freezing of actinic keratoses, Moh’s surgery, and other well-paying procedures. “I’m convinced that private equity may be the undoing of our specialty,” Dr. Coldiron said in an interview.

In a paper titled, “Private Equity Acquisition of Physician Practices,” published in the Annals of Internal Medicine in January 2019, Lawrence Casalino, MD, PhD, chief of the division of health policy and economics at New York’s Weill Cornell Medicine, and colleagues wrote that “private equity firms focus on specialties with high potential for additional income from elective procedures and ancillary services,” and that “dermatology has been a major focus” (Ann Intern Med. 2019;170[2]:114-5).

And in a viewpoint published in JAMA in February 2019, first-year medical student Suhas Gondi and Zirui Song, MD, PhD, both of Harvard Medical School, Boston, concluded that investor-owned practices could drive up overall health spending in part because they extract better reimbursement from insurers (JAMA. 2019;321[11]:1047-8).

Access could also become an issue if the companies drive smaller independent practices out of business, they wrote.

On the other hand, they said, “these investments may also benefit patients and bring more efficiency to a system burdened with waste.” The authors called for more research and “thoughtful regulation” to enhance the potential positives while mitigating the negatives.

So far, the acquisitions have largely escaped the notice of regulators or lawmakers. Congress has made noises about targeting specialty practices owned by private equity as a means of taming surprise medical bills, but that legislation has been stymied.

Dr. Coldiron is convinced that private investors will eventually be tripped up by state laws that prohibit the corporate practice of medicine.

Leslie Baumann, MD, who sold her Miami practice in October 2019 to the investor-owned Skin and Cancer Associates, said critics are too cynical. “What if these private equity firms are going to actually make our specialty better?” she asked in an interview.

What makes dermatology attractive?

Private equity has been acquiring specialty practices since at least 2009, with an acceleration over the last 5 years. Dermatology has been a frequent target, in part because so many dermatologists were in independent or small group private practices, making them ripe for takeover.

A 2015 report on the specialty by Cegedim, a company that provides information technology support to health care, found that the majority of practices had fewer than five physicians and that 57% of the practices were independent.

But more dermatologists are choosing employment. In a 2018 Medscape survey, 57% of dermatologists reported they were employed, while 49% were self-employed.

During 2013-2016, investors bought 35 dermatology practices – comprising 334 physicians, according to one study published in February (JAMA. 2020;323[7]:663-5). Investors bought 69 anesthesiology practices, 43 emergency medicine practices, and 39 family medicine practices during the same period.

Harvard’s Mr. Gondi and Dr. Song estimated that dermatology practices accounted for 15% of investor purchases in 2015 and 2016, even though dermatologists make up just 1% of U.S. clinicians.

In another paper published in JAMA Dermatology, Sally Tan, MD, and colleagues at Brigham and Women’s Hospital, Boston, and Harvard medical and business schools, estimated that, in 2019, at least 184 practices, comprising 381 clinics, were owned by 17 private equity groups and that the acquisitions had been accelerating: from 5 in 2012 to 59 in 2017 to 34 in the first 5 months of 2018 (JAMA Dermatol. 2019;155[9]:1013-21).

“It’s a very attractive area for investors because they know that the future is bright for dermatology,” said Reuven Porges, MD, CEO of Ft. Lauderdale-based Skin and Cancer Associates, which is owned by a private investor. Because dermatology involves providing many ancillary services and cash-only cosmetic services, “it has tremendous potential to continue to be successful in the future regardless of what health care changes are coming,” Dr. Porges said in an interview.

Investors also see promise in dermatology in the United States because “there’s a huge supply demand mismatch,” said Vance Vanier, MD, a cofounding managing partner at Chicago Pacific Founders, the private equity owner of Pinnacle Dermatology, which has 52 locations in Illinois, Indiana, Michigan, Minnesota, and Tennessee.

Theoretically, when investors handle billing, insurance negotiations, and health information technology, it gives clinicians more time to practice, Dr. Vanier said in an interview.

“Once that doctor is freed up to not do administrative tasks and focus on patient care, then, if they want to, they can see more patients and be more responsive to their needs,” he said.

Dr. Vanier said investor acquisitions are here to stay. “This is a trend that could go on for another 50 years before any saturation point is hit,” he said. “It’s a $2 trillion market. It’s hard to wrap your head around how enormous health care services is,” he said.

Dermatology acquisitions will be driven by the continuing imbalance of physician supply and patient demand; the financial pressure on newly graduating physicians who have big debt loads; the requirements for investment in health information technology to report quality metrics; and an aging population, Dr. Vanier said.

In a JAMA Dermatology viewpoint, Jack Resneck Jr., MD, professor of dermatology, University of California, San Francisco, listed many of the same factors – plus a skin cancer epidemic – as fueling dermatology acquisitions (JAMA Dermatol. 2018;154[1]:13-4).

Medical practices – not just dermatology practices – also offer a pure financial play. “Acquisitions of smaller practices provide a major arbitrage opportunity,” Dr. Casalino and colleagues said in the January 2019 Annals of Internal Medicine paper. In a merger of smaller practices into larger, the smaller practice’s valuation immediately becomes that of the bigger one, they wrote.
 

Could the bottom fall out?

Creating giant groups through consolidation is a main aim for private equity.

Skin and Cancer Associates, founded in 1971, was a large entity, with 25 practices. But for a long time, its leaders had wanted to become a regional or a national player, said Dr. Porges. Those leaders asked Dr. Porges – who helped take his former radiology practice through a private equity purchase – to help them attract investors. In March 2018, Susquehanna Private Capital signed on as a “partner” with Skin and Cancer Associates.

It has since almost doubled in size, with 40 locations and 60 dermatologists, all in Florida, Dr. Porges said. “The only limiting factor for growing it as fast as we want, is really money,” he said.

Consolidation is just an initial step. Most investors have a finite timeline for cashing out. “The ultimate goal is often to realize a profitable secondary sale in three to seven years to another PE investor (or even a publicly traded entity),” Dr. Resneck wrote in the 2018 JAMA Dermatology paper.

Not all private equity companies are the same, said Dr. Wernli, of Forefront. Dermatologists can investigate a company’s “hold period” – how long they keep an investment before trading – and the strength of its capitalization before deciding to sell, she said.

Since 2016, Forefront has been owned by the Ontario Municipal Employee Retirement System (OMERS), a pension fund for the province’s public workers. OMERS bought Forefront from Varsity Healthcare Partners, which had owned the dermatology group for just 2 years.

Dr. Wernli said OMERS is a good, solid investor. “They have unlimited resources to invest so they don’t have to quickly flip a company to satisfy an investment in another company,” she said.

Some investor-backed dermatology practices have gone belly up. In 2012, WestWind Investors bought DermOne, based in Toms River, N.J. But by early 2018, the business had fallen apart, and some practices – in North Carolina, New Jersey, Texas, and Virginia – just shut their doors.

Long Island City, N.Y.–based Schweiger Dermatology Group, backed by private equity, snapped up nine of the New Jersey DermOne practices in March 2018.

Another private equity–backed company, U.S. Dermatology Partners, defaulted on a $377 million loan in January 2020. As reported by Bloomberg, the company had $340 million in revenue in 2018. U.S. Dermatology’s owners are reportedly working out a recapitalization or debt-for-equity swap with the lenders.

Dr. Wernli said that financial problems aren’t unique to investor-owned practices and that doctors could still be out of a job if a private practice goes under.

“A private practice can also default on their loans that they’ve used to fund their own personal practice, leaving employed physicians in the same situation,” she said.

Patients are likely to be in the dark, however, until the doors close.

Pressure on practices

Private equity is changing the shape of practice for both those who work for investor-owned businesses and those still out on their own.

The Alabama dermatologist, for instance, said it has made it harder for him to recruit new doctors, who are offered big signing bonuses and a steady income by the investor-owned practices. “They’re skewing the numbers,” he said, adding that residents are now expecting a big payment and benefits.

Dr. Baumann said that when she was on her own, she had trouble finding and recruiting good dermatologists. But it has become easier since she’d sold to Skin and Cancer Associates, she said, noting that Dr. Porges recently found a qualified candidate for her to interview a week after she put in a request.

Another dermatologist in a Midwestern metropolitan practice – who did not want his name used – said that when it came time for him to increase his equity stake, his older partner, who was near retirement and had explored selling to private equity – wanted four-and-a-half times the price that had been discussed when he joined the practice.

The younger partner believes the private equity offers inflated the practice’s valuation in his partner’s mind. He ended up leaving the practice.

Many dermatologists have been led to believe that their practices are worth more than they might be, according to Dr. Coldiron. “I think a lot of these doctors that sell out are deluded. They think that they’re getting a lot of money and they’re not,” he said.

Typically, investors may offer three or four times earnings before interest, taxes, depreciation and amortization (EBITDA). The money paid out is taxed at the capital gains rate, which provides some savings. “But you have to pay that all back, because when they sign you up, you become an employee,” Dr. Coldiron said.

Doctors often agree to work for 5 years, but during that period, their base salary is decreased while the buyout cash is meted out to them, he added. A chunk of the buyout usually is also given as equity, but that equity is worthless unless the investor sells to another entity.

Pinnacle Dermatology doesn’t want doctors to retire immediately upon an acquisition, said Dr. Vanier of Chicago Pacific Founders. “We want to find physician partners who want to keep working,” he said. “We strongly believe if you don’t have strong physician leadership, experienced physician leadership, that your odds of success go down.”

Chicago Pacific also believes physicians should have an ownership interest, he said. It allows them to share in the eventual financial rewards – whether that’s 5 or 20 years later, said Dr. Vanier.

Dr. Coldiron sees other pressures that skew practice styles and can harm patient care. Clinicians in investor-owned practices are often urged to refer all dermatopathology to labs owned by the practice and often, a Moh’s surgeon is employed to service all the practices – sometimes even being flown in from elsewhere, he claimed.

That takes away the clinician’s autonomy in terms of referring where he or she feels appropriate and also could harm pathologists and Moh’s surgeons that depend on those referral streams, he added.

In their paper, Mr. Gondi and Dr. Song wrote that this practice is concerning because “keeping referrals within the practice may render referral patterns less responsive to patient needs or preference.”
 

Procedure factories?

Many critics say investor-backed practices are goosing revenues by hiring more mid-level providers – such as nurse practitioners and physician assistants – and getting them to perform more procedures.

Midlevel practitioners do more biopsies than dermatologists do to get a diagnosis, according to Dr. Coldiron.

A 2018 JAMA Dermatology study appears to back that up. Physician assistants needed to conduct 3.9 biopsies to diagnose one skin cancer, compared to 3.3 for dermatologists. For a single melanoma, the number needed to biopsy was 39.4 for PAs and 25.4 for dermatologists (JAMA Dermatol. 2018;154[5]:569-73).

Skin biopsies have almost doubled in the last decade, said Dr. Coldiron. “The skin cancer epidemic would account for only half of that,” he said.

“The ultimate loser is the patient – because the patient doesn’t get the highest quality care and the patient has unnecessary things done to him or her,” he said. But, he said, he could not directly tie the biopsy increase to the rise of private equity.

Forefront tracks the number of biopsies per patient done by every dermatologist in its network – to make sure that no one is outside the norms set by the Centers for Medicare and Medicaid Services, said Dr. Wernli. And she said biopsies declined after the group was bought by private equity.

Dr. Baumann said the average number of biopsies per patient at Skin and Cancer Associates in 2019 was 0.20 – less than the 0.30 average reported by Medicare that same year.

The rising use of mid-level providers existed long before private equity came on the scene, said Dr. Wernli. “There’s not enough board-certified dermatologists to satisfy need,” she said, noting that, in addition, many clinicians won’t serve rural areas. “If we don’t move and extend ourselves, there will be someone who fills our shoes,” she said, adding that Forefront has 1 mid-level for every 1.5 to 2 dermatologists.

Skin and Cancer Associates has 55 doctors and 29 physician assistants, said Dr. Baumann, adding that she had not been pressured to add any mid-level providers to her practice.
 

Excitement about sale shot down

Dr. Wernli and Dr. Baumann both have been happy with their decision to ally with private equity. For Dr. Baumann, however, her move was tinged by online attacks that reflected the strong opinions on the topic.

She began looking into selling her practice when one of her businesses – Skin Type Solutions – began taking off. Both her clinical practice and research business were thriving. She had two children at home and was having a hard time keeping up with the administrative end of her businesses.

None of her partners nor any groups in Miami showed interest in purchasing the practice, so she began researching private equity. She spoke with seven companies before settling on Skin and Cancer Associates. They had “a long track record of successfully running practices,” said Dr. Baumann, adding that “the doctors who work there are happy, and I respect the quality of the physicians and the organization.”

When she closed the deal in October 2019, she agreed to stay on for 5 years and signed a noncompete clause that she deems “very reasonable.” Among the perks she cites: being able to consult via telemedicine with an expert on pigmented lesions; quick and easy referrals to a Moh’s surgeon; being able to train residents; and having paid personal time off.

It’s less responsibility and the same or better job satisfaction, she said.

But when she shared the news on a private Facebook group for board-certified dermatologists, she was vilified. Of some 195 comments, about half were “mean,” said Dr. Baumann.

“I was shocked about how strongly everybody feels,” she said. Those commenting accused her of doing it for the money or said that her move was contributing to the ruination of dermatology.

“I just defended myself,” she said. “For me, it was my time.”

Dr. Coldiron and Dr. Baumann are members of the Dermatology News editorial advisory board.

The dermatologist had been in practice just a few years when he was approached by a private equity group. This was around 2015, when dermatology was just starting to buzz about investor buyouts. He was curious, so he agreed to meet with the company.

“They approached me with the idea that they could help me grow my practice, help my patients, and cut down overhead,” said the northern Alabama dermatologist, who asked that his name not be used. Over a lavish dinner, the investors lauded the clinician for his business acumen and for having built a great practice so quickly. They made an enticing buyout offer.

Ja_inter/DigitalVision Vectors

Salvation or death sentence?

Depending on whom you ask, the continuing growth of private equity purchases of dermatology practices is either the death – or salvation – of the specialty.

Many dermatologists question whether the financial backers will invest in quality of care, or if they just will hire mid-level providers to churn out procedures to plump up revenues.

Neither the controversy nor the acquisitions show any sign of abating.

The American Academy of Dermatology has hosted debates on the topic at its annual meetings – and was to do so in 2020 until COVID-19 led to the meeting’s cancellation. AAD has not weighed in with any official policy and is not releasing data it may be collecting on the potential impact of private equity ownership. The organization provided a statement from President George J. Hruza, MD, who said, “the AAD supports a member’s right to choose the model that works best for them,” adding that the Academy “expects its members to provide safe and effective patient care, regardless of a dermatologist’s practice setting.” Dr. Hruza sold his Chesterfield, Mo., practice to United Skin Specialists, a private equity–backed company, in 2016, and still works at the same practice.

Some have said the acquisitions need to stop. “Until meaningful data are available on what happens to the quality of care and affordability for patients and payers, dermatologists should stop selling their practices to private equity firms, and legislators should prohibit such transactions,” wrote Joshua M. Sharfstein, MD, and Jamar Slocum, MD, of the Johns Hopkins Bloomberg School of Public Health, Baltimore, in an editorial in July (JAMA Dermatol. 2019;155[9]:1007-8).

Although he acknowledged that he has not tracked the issue closely and that little data exist on the impact on quality or cost, Dr. Sharfstein has not changed his tune. “I think there are enough warning signs to say we should put the brakes on,” he said in an interview.

“For what reason?” asked Betsy Wernli, MD, president of Forefront Dermatology, an investor-owned group based in Manitowoc, Wis. She said it seems that “on this topic, we abandon our scientific foundations and default to emotion and anecdote,” she said in an interview. “Having capital, and an investor that supports us has allowed us to perform better patient care,” she said. Dermatologist variance across all practices and practice models should be cause for more concern, she added.

Sailesh Konda, MD, has been an outspoken critic. Dr. Konda, medical director and clinical assistant professor in the department of dermatology at the University of Florida, Gainesville, and colleagues detailed the complicated financial machinations of private equity in the Journal of the American Academy of Dermatology. They showed that private investors seemed to hone in on buying outlier practices that performed high numbers of procedures. The paper – first made public in the fall of 2018 – created an uproar, especially among private equity companies. It was initially removed from the website in conjunction with a request from the editor that its conclusions be altered to be less harsh on private equity, according to the New York Times. The paper was eventually published in 2019 (J Am Acad Dermatol. Jul;81[1]:287-296.e8).

Dr. Konda has spoken at various dermatology forums and health care gatherings on private equity. He told the Times that he had given 16 talks to health care groups in 2018, and he was due to speak to a health care investors’ group in 2020. But he would not comment on the record for this story.

Brett Coldiron, MD, a former president of the AAD, also has been critical. He believes investor-owners push for more biopsies, freezing of actinic keratoses, Moh’s surgery, and other well-paying procedures. “I’m convinced that private equity may be the undoing of our specialty,” Dr. Coldiron said in an interview.

In a paper titled, “Private Equity Acquisition of Physician Practices,” published in the Annals of Internal Medicine in January 2019, Lawrence Casalino, MD, PhD, chief of the division of health policy and economics at New York’s Weill Cornell Medicine, and colleagues wrote that “private equity firms focus on specialties with high potential for additional income from elective procedures and ancillary services,” and that “dermatology has been a major focus” (Ann Intern Med. 2019;170[2]:114-5).

And in a viewpoint published in JAMA in February 2019, first-year medical student Suhas Gondi and Zirui Song, MD, PhD, both of Harvard Medical School, Boston, concluded that investor-owned practices could drive up overall health spending in part because they extract better reimbursement from insurers (JAMA. 2019;321[11]:1047-8).

Access could also become an issue if the companies drive smaller independent practices out of business, they wrote.

On the other hand, they said, “these investments may also benefit patients and bring more efficiency to a system burdened with waste.” The authors called for more research and “thoughtful regulation” to enhance the potential positives while mitigating the negatives.

So far, the acquisitions have largely escaped the notice of regulators or lawmakers. Congress has made noises about targeting specialty practices owned by private equity as a means of taming surprise medical bills, but that legislation has been stymied.

Dr. Coldiron is convinced that private investors will eventually be tripped up by state laws that prohibit the corporate practice of medicine.

Leslie Baumann, MD, who sold her Miami practice in October 2019 to the investor-owned Skin and Cancer Associates, said critics are too cynical. “What if these private equity firms are going to actually make our specialty better?” she asked in an interview.

What makes dermatology attractive?

Private equity has been acquiring specialty practices since at least 2009, with an acceleration over the last 5 years. Dermatology has been a frequent target, in part because so many dermatologists were in independent or small group private practices, making them ripe for takeover.

A 2015 report on the specialty by Cegedim, a company that provides information technology support to health care, found that the majority of practices had fewer than five physicians and that 57% of the practices were independent.

But more dermatologists are choosing employment. In a 2018 Medscape survey, 57% of dermatologists reported they were employed, while 49% were self-employed.

During 2013-2016, investors bought 35 dermatology practices – comprising 334 physicians, according to one study published in February (JAMA. 2020;323[7]:663-5). Investors bought 69 anesthesiology practices, 43 emergency medicine practices, and 39 family medicine practices during the same period.

Harvard’s Mr. Gondi and Dr. Song estimated that dermatology practices accounted for 15% of investor purchases in 2015 and 2016, even though dermatologists make up just 1% of U.S. clinicians.

In another paper published in JAMA Dermatology, Sally Tan, MD, and colleagues at Brigham and Women’s Hospital, Boston, and Harvard medical and business schools, estimated that, in 2019, at least 184 practices, comprising 381 clinics, were owned by 17 private equity groups and that the acquisitions had been accelerating: from 5 in 2012 to 59 in 2017 to 34 in the first 5 months of 2018 (JAMA Dermatol. 2019;155[9]:1013-21).

“It’s a very attractive area for investors because they know that the future is bright for dermatology,” said Reuven Porges, MD, CEO of Ft. Lauderdale-based Skin and Cancer Associates, which is owned by a private investor. Because dermatology involves providing many ancillary services and cash-only cosmetic services, “it has tremendous potential to continue to be successful in the future regardless of what health care changes are coming,” Dr. Porges said in an interview.

Investors also see promise in dermatology in the United States because “there’s a huge supply demand mismatch,” said Vance Vanier, MD, a cofounding managing partner at Chicago Pacific Founders, the private equity owner of Pinnacle Dermatology, which has 52 locations in Illinois, Indiana, Michigan, Minnesota, and Tennessee.

Theoretically, when investors handle billing, insurance negotiations, and health information technology, it gives clinicians more time to practice, Dr. Vanier said in an interview.

“Once that doctor is freed up to not do administrative tasks and focus on patient care, then, if they want to, they can see more patients and be more responsive to their needs,” he said.

Dr. Vanier said investor acquisitions are here to stay. “This is a trend that could go on for another 50 years before any saturation point is hit,” he said. “It’s a $2 trillion market. It’s hard to wrap your head around how enormous health care services is,” he said.

Dermatology acquisitions will be driven by the continuing imbalance of physician supply and patient demand; the financial pressure on newly graduating physicians who have big debt loads; the requirements for investment in health information technology to report quality metrics; and an aging population, Dr. Vanier said.

In a JAMA Dermatology viewpoint, Jack Resneck Jr., MD, professor of dermatology, University of California, San Francisco, listed many of the same factors – plus a skin cancer epidemic – as fueling dermatology acquisitions (JAMA Dermatol. 2018;154[1]:13-4).

Medical practices – not just dermatology practices – also offer a pure financial play. “Acquisitions of smaller practices provide a major arbitrage opportunity,” Dr. Casalino and colleagues said in the January 2019 Annals of Internal Medicine paper. In a merger of smaller practices into larger, the smaller practice’s valuation immediately becomes that of the bigger one, they wrote.
 

Could the bottom fall out?

Creating giant groups through consolidation is a main aim for private equity.

Skin and Cancer Associates, founded in 1971, was a large entity, with 25 practices. But for a long time, its leaders had wanted to become a regional or a national player, said Dr. Porges. Those leaders asked Dr. Porges – who helped take his former radiology practice through a private equity purchase – to help them attract investors. In March 2018, Susquehanna Private Capital signed on as a “partner” with Skin and Cancer Associates.

It has since almost doubled in size, with 40 locations and 60 dermatologists, all in Florida, Dr. Porges said. “The only limiting factor for growing it as fast as we want, is really money,” he said.

Consolidation is just an initial step. Most investors have a finite timeline for cashing out. “The ultimate goal is often to realize a profitable secondary sale in three to seven years to another PE investor (or even a publicly traded entity),” Dr. Resneck wrote in the 2018 JAMA Dermatology paper.

Not all private equity companies are the same, said Dr. Wernli, of Forefront. Dermatologists can investigate a company’s “hold period” – how long they keep an investment before trading – and the strength of its capitalization before deciding to sell, she said.

Since 2016, Forefront has been owned by the Ontario Municipal Employee Retirement System (OMERS), a pension fund for the province’s public workers. OMERS bought Forefront from Varsity Healthcare Partners, which had owned the dermatology group for just 2 years.

Dr. Wernli said OMERS is a good, solid investor. “They have unlimited resources to invest so they don’t have to quickly flip a company to satisfy an investment in another company,” she said.

Some investor-backed dermatology practices have gone belly up. In 2012, WestWind Investors bought DermOne, based in Toms River, N.J. But by early 2018, the business had fallen apart, and some practices – in North Carolina, New Jersey, Texas, and Virginia – just shut their doors.

Long Island City, N.Y.–based Schweiger Dermatology Group, backed by private equity, snapped up nine of the New Jersey DermOne practices in March 2018.

Another private equity–backed company, U.S. Dermatology Partners, defaulted on a $377 million loan in January 2020. As reported by Bloomberg, the company had $340 million in revenue in 2018. U.S. Dermatology’s owners are reportedly working out a recapitalization or debt-for-equity swap with the lenders.

Dr. Wernli said that financial problems aren’t unique to investor-owned practices and that doctors could still be out of a job if a private practice goes under.

“A private practice can also default on their loans that they’ve used to fund their own personal practice, leaving employed physicians in the same situation,” she said.

Patients are likely to be in the dark, however, until the doors close.

Pressure on practices

Private equity is changing the shape of practice for both those who work for investor-owned businesses and those still out on their own.

The Alabama dermatologist, for instance, said it has made it harder for him to recruit new doctors, who are offered big signing bonuses and a steady income by the investor-owned practices. “They’re skewing the numbers,” he said, adding that residents are now expecting a big payment and benefits.

Dr. Baumann said that when she was on her own, she had trouble finding and recruiting good dermatologists. But it has become easier since she’d sold to Skin and Cancer Associates, she said, noting that Dr. Porges recently found a qualified candidate for her to interview a week after she put in a request.

Another dermatologist in a Midwestern metropolitan practice – who did not want his name used – said that when it came time for him to increase his equity stake, his older partner, who was near retirement and had explored selling to private equity – wanted four-and-a-half times the price that had been discussed when he joined the practice.

The younger partner believes the private equity offers inflated the practice’s valuation in his partner’s mind. He ended up leaving the practice.

Many dermatologists have been led to believe that their practices are worth more than they might be, according to Dr. Coldiron. “I think a lot of these doctors that sell out are deluded. They think that they’re getting a lot of money and they’re not,” he said.

Typically, investors may offer three or four times earnings before interest, taxes, depreciation and amortization (EBITDA). The money paid out is taxed at the capital gains rate, which provides some savings. “But you have to pay that all back, because when they sign you up, you become an employee,” Dr. Coldiron said.

Doctors often agree to work for 5 years, but during that period, their base salary is decreased while the buyout cash is meted out to them, he added. A chunk of the buyout usually is also given as equity, but that equity is worthless unless the investor sells to another entity.

Pinnacle Dermatology doesn’t want doctors to retire immediately upon an acquisition, said Dr. Vanier of Chicago Pacific Founders. “We want to find physician partners who want to keep working,” he said. “We strongly believe if you don’t have strong physician leadership, experienced physician leadership, that your odds of success go down.”

Chicago Pacific also believes physicians should have an ownership interest, he said. It allows them to share in the eventual financial rewards – whether that’s 5 or 20 years later, said Dr. Vanier.

Dr. Coldiron sees other pressures that skew practice styles and can harm patient care. Clinicians in investor-owned practices are often urged to refer all dermatopathology to labs owned by the practice and often, a Moh’s surgeon is employed to service all the practices – sometimes even being flown in from elsewhere, he claimed.

That takes away the clinician’s autonomy in terms of referring where he or she feels appropriate and also could harm pathologists and Moh’s surgeons that depend on those referral streams, he added.

In their paper, Mr. Gondi and Dr. Song wrote that this practice is concerning because “keeping referrals within the practice may render referral patterns less responsive to patient needs or preference.”
 

Procedure factories?

Many critics say investor-backed practices are goosing revenues by hiring more mid-level providers – such as nurse practitioners and physician assistants – and getting them to perform more procedures.

Midlevel practitioners do more biopsies than dermatologists do to get a diagnosis, according to Dr. Coldiron.

A 2018 JAMA Dermatology study appears to back that up. Physician assistants needed to conduct 3.9 biopsies to diagnose one skin cancer, compared to 3.3 for dermatologists. For a single melanoma, the number needed to biopsy was 39.4 for PAs and 25.4 for dermatologists (JAMA Dermatol. 2018;154[5]:569-73).

Skin biopsies have almost doubled in the last decade, said Dr. Coldiron. “The skin cancer epidemic would account for only half of that,” he said.

“The ultimate loser is the patient – because the patient doesn’t get the highest quality care and the patient has unnecessary things done to him or her,” he said. But, he said, he could not directly tie the biopsy increase to the rise of private equity.

Forefront tracks the number of biopsies per patient done by every dermatologist in its network – to make sure that no one is outside the norms set by the Centers for Medicare and Medicaid Services, said Dr. Wernli. And she said biopsies declined after the group was bought by private equity.

Dr. Baumann said the average number of biopsies per patient at Skin and Cancer Associates in 2019 was 0.20 – less than the 0.30 average reported by Medicare that same year.

The rising use of mid-level providers existed long before private equity came on the scene, said Dr. Wernli. “There’s not enough board-certified dermatologists to satisfy need,” she said, noting that, in addition, many clinicians won’t serve rural areas. “If we don’t move and extend ourselves, there will be someone who fills our shoes,” she said, adding that Forefront has 1 mid-level for every 1.5 to 2 dermatologists.

Skin and Cancer Associates has 55 doctors and 29 physician assistants, said Dr. Baumann, adding that she had not been pressured to add any mid-level providers to her practice.
 

Excitement about sale shot down

Dr. Wernli and Dr. Baumann both have been happy with their decision to ally with private equity. For Dr. Baumann, however, her move was tinged by online attacks that reflected the strong opinions on the topic.

She began looking into selling her practice when one of her businesses – Skin Type Solutions – began taking off. Both her clinical practice and research business were thriving. She had two children at home and was having a hard time keeping up with the administrative end of her businesses.

None of her partners nor any groups in Miami showed interest in purchasing the practice, so she began researching private equity. She spoke with seven companies before settling on Skin and Cancer Associates. They had “a long track record of successfully running practices,” said Dr. Baumann, adding that “the doctors who work there are happy, and I respect the quality of the physicians and the organization.”

When she closed the deal in October 2019, she agreed to stay on for 5 years and signed a noncompete clause that she deems “very reasonable.” Among the perks she cites: being able to consult via telemedicine with an expert on pigmented lesions; quick and easy referrals to a Moh’s surgeon; being able to train residents; and having paid personal time off.

It’s less responsibility and the same or better job satisfaction, she said.

But when she shared the news on a private Facebook group for board-certified dermatologists, she was vilified. Of some 195 comments, about half were “mean,” said Dr. Baumann.

“I was shocked about how strongly everybody feels,” she said. Those commenting accused her of doing it for the money or said that her move was contributing to the ruination of dermatology.

“I just defended myself,” she said. “For me, it was my time.”

Dr. Coldiron and Dr. Baumann are members of the Dermatology News editorial advisory board.

As evidence piles up documenting a sudden loss of smell and/or taste as a presenting symptom of COVID-19, the call to screen for these phenomena is growing.

A number of new publications show that a high proportion of people infected with COVID-19 report loss of smell and/or taste, with their authors adding to the clamor to recognize these symptoms as potentially indicative of the infection.

In particular, there is a belief that these signs may be present in many with asymptomatic COVID-19, and therefore asking about them could be a way to prioritize people for initial testing for the SARS-CoV-2 virus in the absence of other symptoms.

Anyone testing positive could then quarantine, and their contacts could be traced.

Despite this, the World Health Organization (WHO) has not listed loss of smell or taste as potential symptoms of SARS-CoV-2 infection.

But the US Centers for Disease Control and Prevention (CDC) has now added “new loss of taste or smell” as a symptom on its COVID-19 information page.

American Academy of Otolaryngology—Head and Neck Surgery (AAO-HNS) executive vice president and CEO James C. Denneny III, MD, believes the symptoms may be an early warning signal.

And there’s no downside to checking for these, Denneny told Medscape Medical News.

“Given the fact that this doesn’t require any surgical procedure, biopsy, or specific treatment, I think the upside of getting it early is great,” he said. “The downside of using it as a symptom, and if someone doesn’t turn out to have it, is virtually zero.”

Claire Hopkins, MD, president of the British Rhinological Society, and colleagues, writing in Lancet Infectious Diseases, agree.

“Physicians evaluating patients with acute-onset loss of smell or taste, particularly in the context of a patent nasal airway, should have a high index of suspicion for concomitant SARS-CoV-2 infection.”

They also observe that this appears to occur, in contrast to other respiratory infections, “in the absence of nasal congestion or rhinorrhea.”
 

Newest Publications Find Smell and Taste Loss Is Common

Author of one of the newly published studies, Carol H. Yan, MD, an otolaryngologist and head and neck surgeon at the University of California, San Diego, also thinks that sudden smell and taste loss seem to be fairly specific markers of COVID-19.

In her survey of patients who presented to UC San Diego Health for SARS-CoV-2 testing, Yan and colleagues reported that 68% (40 of 59) of COVID-19–positive patients reported olfactory impairment and 71% (42 of 59) reported taste impairment.

Among the 203 people in the “control” group who were polymerase chain reaction–negative (PCR–) for SARS-CoV-2, just 16% had smell loss and 17% had taste loss, according to their results published in the International Forum of Allergy & Rhinology.

“Based on our study, if you have smell and taste loss, you are more than 10 times more likely to have COVID-19 infection than other causes of infection. The most common first sign of a COVID-19 infection remains fever, but fatigue and loss of smell and taste follow as other very common initial symptoms,” said Yan.

“We know COVID-19 is an extremely contagious virus. This study supports the need to be aware of smell and taste loss as early signs of COVID-19.”

Yan told Medscape Medical News that another not-yet-published analysis indicates that sudden loss of smell or taste “may be more representative of a mild form of disease.”

Getting these people tested and isolated could therefore help prevent spread of COVID-19, she urged.

Based on Yan’s report and other case reports, the UC San Diego Health system is now asking all callers to its COVID-19 hotlines, and all visitors and staff, if they’ve had a sudden loss of taste or smell in the last few weeks, she explained.

And Ahmad R. Sedaghat, MD, PhD, at the University of Cincinnati, Ohio, takes a similar view.

In a new systematic review of the topic published April 14 in Laryngoscope Investigative Otolaryngology, Sedaghat and colleagues write: “Anosmia (total loss of smell) without nasal obstruction, in particular, appears to be a highly specific indicator of COVID-19.”

Sedaghat said a sudden loss of sense of smell wouldn’t necessarily lead people to think they have COVID-19, particularly if they remain asymptomatic, so “these individuals could continue business as usual and spread the disease as a carrier.”

“If someone experiences anosmia without nasal obstruction, aside from quarantining, it would not be unreasonable to reach out to one’s primary care physician about getting tested,” he said in a statement from his institution.
 

Symptom Checkers Add Weight

Several organizations around the world have begun collecting symptom reports from patients and clinicians, which has shone more light on the sudden loss of taste and smell as potential flags for COVID-19.

In an April 14 Morbidity and Mortality Weekly report from the CDC on COVID-19 infections in healthcare workers, of the 5000 who reported symptoms, 750 (16%) wrote “loss of smell or taste” as an “other” symptom.

Meanwhile, the COVID Symptom Tracker smartphone app, a joint effort by Massachusetts General Hospital, Boston, Stanford (Calif.) University, and King’s College, London, which as of press time, was monitoring some 2.5 million people, has had similar findings.

In a preprint publication on 400,000 people reporting one or more symptoms between March 24 and 29 on the tracker, 18% had lost their sense of smell or taste — more than the 10% who reported fever, but far less than the 53% who reported fatigue.

Only 1702 of the 400,000 had received a COVID-19 test.

Of those, 579 had tested positive and 1123 were negative.

The organizers estimated that of those who were positive, 59% reported losing smell or taste, compared with just 18% who tested negative.

“When combined with other symptoms, people with loss of smell and taste appear to be three times more likely to have contracted COVID-19 according to our data,” said Tim Spector, MD, a genetic epidemiologist at King’s College and the app’s lead researcher, on the symptom tracker’s website.

These people “should therefore self-isolate for 7 days to reduce the spread of the disease,” he urged.
 

Anosmia Is the Initial Symptom in Many Patients With COVID-19

The AAO-HNS also began collecting data from physicians and patients on March 25 through its Web-based 16-question symptom tracking tool.

It has received more than 500 reports of sudden taste or smell loss, said Denneny.

In a report on the first 237 responses, published in Otolaryngology-Head and Neck Surgery, anosmia (profound loss of smell) was found in 73% of subjects before a COVID-19 diagnosis and was the initial symptom in 27% of those subjects.

That latter determination “was the single most important finding,” said Denneny, noting it shows that smell and taste loss are “a sentinel symptom.”

Anosmia led to testing in only 40% of the cases.

Half of the reports came from otolaryngologists, but a large number came from other medical specialties, especially from family medicine.

Just 2% of reports came from patients in that first group, which was based on responses through April 3.

Denneny said that more reports are now coming in from patients, which he attributes to widespread media coverage about the loss of taste and smell.

It’s still not entirely clear why SARS-CoV-2 might inhibit taste or smell. More common viruses like influenza and other coronaviruses can also cause smell and taste loss.

So far, it seems like the sensory recovery is faster for SARS-CoV-2 than the other viruses, which suggests a potentially different mechanism of action, said Yan. Patients she surveyed at UC San Diego recovered the senses within a few weeks to a month, compared to months or a year with the more common viruses.

Yan’s study was partially supported by the National Institutes of Health. Sedaghat has reported no relevant financial relationships. The COVID Symptom Tracker is supported by Zoe Global Limited and has received grants from the Wellcome Trust, Medical Research Council/British Heart Foundation, and Biological Informative Markers for Stratification of Hypertension.

This article first appeared on Medscape.com.

As evidence piles up documenting a sudden loss of smell and/or taste as a presenting symptom of COVID-19, the call to screen for these phenomena is growing.

A number of new publications show that a high proportion of people infected with COVID-19 report loss of smell and/or taste, with their authors adding to the clamor to recognize these symptoms as potentially indicative of the infection.

In particular, there is a belief that these signs may be present in many with asymptomatic COVID-19, and therefore asking about them could be a way to prioritize people for initial testing for the SARS-CoV-2 virus in the absence of other symptoms.

Anyone testing positive could then quarantine, and their contacts could be traced.

Despite this, the World Health Organization (WHO) has not listed loss of smell or taste as potential symptoms of SARS-CoV-2 infection.

But the US Centers for Disease Control and Prevention (CDC) has now added “new loss of taste or smell” as a symptom on its COVID-19 information page.

American Academy of Otolaryngology—Head and Neck Surgery (AAO-HNS) executive vice president and CEO James C. Denneny III, MD, believes the symptoms may be an early warning signal.

And there’s no downside to checking for these, Denneny told Medscape Medical News.

“Given the fact that this doesn’t require any surgical procedure, biopsy, or specific treatment, I think the upside of getting it early is great,” he said. “The downside of using it as a symptom, and if someone doesn’t turn out to have it, is virtually zero.”

Claire Hopkins, MD, president of the British Rhinological Society, and colleagues, writing in Lancet Infectious Diseases, agree.

“Physicians evaluating patients with acute-onset loss of smell or taste, particularly in the context of a patent nasal airway, should have a high index of suspicion for concomitant SARS-CoV-2 infection.”

They also observe that this appears to occur, in contrast to other respiratory infections, “in the absence of nasal congestion or rhinorrhea.”
 

Newest Publications Find Smell and Taste Loss Is Common

Author of one of the newly published studies, Carol H. Yan, MD, an otolaryngologist and head and neck surgeon at the University of California, San Diego, also thinks that sudden smell and taste loss seem to be fairly specific markers of COVID-19.

In her survey of patients who presented to UC San Diego Health for SARS-CoV-2 testing, Yan and colleagues reported that 68% (40 of 59) of COVID-19–positive patients reported olfactory impairment and 71% (42 of 59) reported taste impairment.

Among the 203 people in the “control” group who were polymerase chain reaction–negative (PCR–) for SARS-CoV-2, just 16% had smell loss and 17% had taste loss, according to their results published in the International Forum of Allergy & Rhinology.

“Based on our study, if you have smell and taste loss, you are more than 10 times more likely to have COVID-19 infection than other causes of infection. The most common first sign of a COVID-19 infection remains fever, but fatigue and loss of smell and taste follow as other very common initial symptoms,” said Yan.

“We know COVID-19 is an extremely contagious virus. This study supports the need to be aware of smell and taste loss as early signs of COVID-19.”

Yan told Medscape Medical News that another not-yet-published analysis indicates that sudden loss of smell or taste “may be more representative of a mild form of disease.”

Getting these people tested and isolated could therefore help prevent spread of COVID-19, she urged.

Based on Yan’s report and other case reports, the UC San Diego Health system is now asking all callers to its COVID-19 hotlines, and all visitors and staff, if they’ve had a sudden loss of taste or smell in the last few weeks, she explained.

And Ahmad R. Sedaghat, MD, PhD, at the University of Cincinnati, Ohio, takes a similar view.

In a new systematic review of the topic published April 14 in Laryngoscope Investigative Otolaryngology, Sedaghat and colleagues write: “Anosmia (total loss of smell) without nasal obstruction, in particular, appears to be a highly specific indicator of COVID-19.”

Sedaghat said a sudden loss of sense of smell wouldn’t necessarily lead people to think they have COVID-19, particularly if they remain asymptomatic, so “these individuals could continue business as usual and spread the disease as a carrier.”

“If someone experiences anosmia without nasal obstruction, aside from quarantining, it would not be unreasonable to reach out to one’s primary care physician about getting tested,” he said in a statement from his institution.
 

Symptom Checkers Add Weight

Several organizations around the world have begun collecting symptom reports from patients and clinicians, which has shone more light on the sudden loss of taste and smell as potential flags for COVID-19.

In an April 14 Morbidity and Mortality Weekly report from the CDC on COVID-19 infections in healthcare workers, of the 5000 who reported symptoms, 750 (16%) wrote “loss of smell or taste” as an “other” symptom.

Meanwhile, the COVID Symptom Tracker smartphone app, a joint effort by Massachusetts General Hospital, Boston, Stanford (Calif.) University, and King’s College, London, which as of press time, was monitoring some 2.5 million people, has had similar findings.

In a preprint publication on 400,000 people reporting one or more symptoms between March 24 and 29 on the tracker, 18% had lost their sense of smell or taste — more than the 10% who reported fever, but far less than the 53% who reported fatigue.

Only 1702 of the 400,000 had received a COVID-19 test.

Of those, 579 had tested positive and 1123 were negative.

The organizers estimated that of those who were positive, 59% reported losing smell or taste, compared with just 18% who tested negative.

“When combined with other symptoms, people with loss of smell and taste appear to be three times more likely to have contracted COVID-19 according to our data,” said Tim Spector, MD, a genetic epidemiologist at King’s College and the app’s lead researcher, on the symptom tracker’s website.

These people “should therefore self-isolate for 7 days to reduce the spread of the disease,” he urged.
 

Anosmia Is the Initial Symptom in Many Patients With COVID-19

The AAO-HNS also began collecting data from physicians and patients on March 25 through its Web-based 16-question symptom tracking tool.

It has received more than 500 reports of sudden taste or smell loss, said Denneny.

In a report on the first 237 responses, published in Otolaryngology-Head and Neck Surgery, anosmia (profound loss of smell) was found in 73% of subjects before a COVID-19 diagnosis and was the initial symptom in 27% of those subjects.

That latter determination “was the single most important finding,” said Denneny, noting it shows that smell and taste loss are “a sentinel symptom.”

Anosmia led to testing in only 40% of the cases.

Half of the reports came from otolaryngologists, but a large number came from other medical specialties, especially from family medicine.

Just 2% of reports came from patients in that first group, which was based on responses through April 3.

Denneny said that more reports are now coming in from patients, which he attributes to widespread media coverage about the loss of taste and smell.

It’s still not entirely clear why SARS-CoV-2 might inhibit taste or smell. More common viruses like influenza and other coronaviruses can also cause smell and taste loss.

So far, it seems like the sensory recovery is faster for SARS-CoV-2 than the other viruses, which suggests a potentially different mechanism of action, said Yan. Patients she surveyed at UC San Diego recovered the senses within a few weeks to a month, compared to months or a year with the more common viruses.

Yan’s study was partially supported by the National Institutes of Health. Sedaghat has reported no relevant financial relationships. The COVID Symptom Tracker is supported by Zoe Global Limited and has received grants from the Wellcome Trust, Medical Research Council/British Heart Foundation, and Biological Informative Markers for Stratification of Hypertension.

This article first appeared on Medscape.com.

As evidence piles up documenting a sudden loss of smell and/or taste as a presenting symptom of COVID-19, the call to screen for these phenomena is growing.

A number of new publications show that a high proportion of people infected with COVID-19 report loss of smell and/or taste, with their authors adding to the clamor to recognize these symptoms as potentially indicative of the infection.

In particular, there is a belief that these signs may be present in many with asymptomatic COVID-19, and therefore asking about them could be a way to prioritize people for initial testing for the SARS-CoV-2 virus in the absence of other symptoms.

Anyone testing positive could then quarantine, and their contacts could be traced.

Despite this, the World Health Organization (WHO) has not listed loss of smell or taste as potential symptoms of SARS-CoV-2 infection.

But the US Centers for Disease Control and Prevention (CDC) has now added “new loss of taste or smell” as a symptom on its COVID-19 information page.

American Academy of Otolaryngology—Head and Neck Surgery (AAO-HNS) executive vice president and CEO James C. Denneny III, MD, believes the symptoms may be an early warning signal.

And there’s no downside to checking for these, Denneny told Medscape Medical News.

“Given the fact that this doesn’t require any surgical procedure, biopsy, or specific treatment, I think the upside of getting it early is great,” he said. “The downside of using it as a symptom, and if someone doesn’t turn out to have it, is virtually zero.”

Claire Hopkins, MD, president of the British Rhinological Society, and colleagues, writing in Lancet Infectious Diseases, agree.

“Physicians evaluating patients with acute-onset loss of smell or taste, particularly in the context of a patent nasal airway, should have a high index of suspicion for concomitant SARS-CoV-2 infection.”

They also observe that this appears to occur, in contrast to other respiratory infections, “in the absence of nasal congestion or rhinorrhea.”
 

Newest Publications Find Smell and Taste Loss Is Common

Author of one of the newly published studies, Carol H. Yan, MD, an otolaryngologist and head and neck surgeon at the University of California, San Diego, also thinks that sudden smell and taste loss seem to be fairly specific markers of COVID-19.

In her survey of patients who presented to UC San Diego Health for SARS-CoV-2 testing, Yan and colleagues reported that 68% (40 of 59) of COVID-19–positive patients reported olfactory impairment and 71% (42 of 59) reported taste impairment.

Among the 203 people in the “control” group who were polymerase chain reaction–negative (PCR–) for SARS-CoV-2, just 16% had smell loss and 17% had taste loss, according to their results published in the International Forum of Allergy & Rhinology.

“Based on our study, if you have smell and taste loss, you are more than 10 times more likely to have COVID-19 infection than other causes of infection. The most common first sign of a COVID-19 infection remains fever, but fatigue and loss of smell and taste follow as other very common initial symptoms,” said Yan.

“We know COVID-19 is an extremely contagious virus. This study supports the need to be aware of smell and taste loss as early signs of COVID-19.”

Yan told Medscape Medical News that another not-yet-published analysis indicates that sudden loss of smell or taste “may be more representative of a mild form of disease.”

Getting these people tested and isolated could therefore help prevent spread of COVID-19, she urged.

Based on Yan’s report and other case reports, the UC San Diego Health system is now asking all callers to its COVID-19 hotlines, and all visitors and staff, if they’ve had a sudden loss of taste or smell in the last few weeks, she explained.

And Ahmad R. Sedaghat, MD, PhD, at the University of Cincinnati, Ohio, takes a similar view.

In a new systematic review of the topic published April 14 in Laryngoscope Investigative Otolaryngology, Sedaghat and colleagues write: “Anosmia (total loss of smell) without nasal obstruction, in particular, appears to be a highly specific indicator of COVID-19.”

Sedaghat said a sudden loss of sense of smell wouldn’t necessarily lead people to think they have COVID-19, particularly if they remain asymptomatic, so “these individuals could continue business as usual and spread the disease as a carrier.”

“If someone experiences anosmia without nasal obstruction, aside from quarantining, it would not be unreasonable to reach out to one’s primary care physician about getting tested,” he said in a statement from his institution.
 

Symptom Checkers Add Weight

Several organizations around the world have begun collecting symptom reports from patients and clinicians, which has shone more light on the sudden loss of taste and smell as potential flags for COVID-19.

In an April 14 Morbidity and Mortality Weekly report from the CDC on COVID-19 infections in healthcare workers, of the 5000 who reported symptoms, 750 (16%) wrote “loss of smell or taste” as an “other” symptom.

Meanwhile, the COVID Symptom Tracker smartphone app, a joint effort by Massachusetts General Hospital, Boston, Stanford (Calif.) University, and King’s College, London, which as of press time, was monitoring some 2.5 million people, has had similar findings.

In a preprint publication on 400,000 people reporting one or more symptoms between March 24 and 29 on the tracker, 18% had lost their sense of smell or taste — more than the 10% who reported fever, but far less than the 53% who reported fatigue.

Only 1702 of the 400,000 had received a COVID-19 test.

Of those, 579 had tested positive and 1123 were negative.

The organizers estimated that of those who were positive, 59% reported losing smell or taste, compared with just 18% who tested negative.

“When combined with other symptoms, people with loss of smell and taste appear to be three times more likely to have contracted COVID-19 according to our data,” said Tim Spector, MD, a genetic epidemiologist at King’s College and the app’s lead researcher, on the symptom tracker’s website.

These people “should therefore self-isolate for 7 days to reduce the spread of the disease,” he urged.
 

Anosmia Is the Initial Symptom in Many Patients With COVID-19

The AAO-HNS also began collecting data from physicians and patients on March 25 through its Web-based 16-question symptom tracking tool.

It has received more than 500 reports of sudden taste or smell loss, said Denneny.

In a report on the first 237 responses, published in Otolaryngology-Head and Neck Surgery, anosmia (profound loss of smell) was found in 73% of subjects before a COVID-19 diagnosis and was the initial symptom in 27% of those subjects.

That latter determination “was the single most important finding,” said Denneny, noting it shows that smell and taste loss are “a sentinel symptom.”

Anosmia led to testing in only 40% of the cases.

Half of the reports came from otolaryngologists, but a large number came from other medical specialties, especially from family medicine.

Just 2% of reports came from patients in that first group, which was based on responses through April 3.

Denneny said that more reports are now coming in from patients, which he attributes to widespread media coverage about the loss of taste and smell.

It’s still not entirely clear why SARS-CoV-2 might inhibit taste or smell. More common viruses like influenza and other coronaviruses can also cause smell and taste loss.

So far, it seems like the sensory recovery is faster for SARS-CoV-2 than the other viruses, which suggests a potentially different mechanism of action, said Yan. Patients she surveyed at UC San Diego recovered the senses within a few weeks to a month, compared to months or a year with the more common viruses.

Yan’s study was partially supported by the National Institutes of Health. Sedaghat has reported no relevant financial relationships. The COVID Symptom Tracker is supported by Zoe Global Limited and has received grants from the Wellcome Trust, Medical Research Council/British Heart Foundation, and Biological Informative Markers for Stratification of Hypertension.

This article first appeared on Medscape.com.

Although conflicting, the available data indicate that SARS-CoV-2 could continue to spread in warmer spring and summer months in the US, according to a new report from the National Academies of Science, Engineering, and Medicine (NAS).

Current data suggest that the novel coronavirus may be transmitted less efficiently in higher temperatures and humidity, but the studies are not conclusive because of poor data quality, confounding factors, and the relatively short existence of the pandemic, which makes it difficult to determine its true course, writes David A. Relman, MD, a member of the NAS’ Standing Committee on Emerging Infectious Diseases and 21st Century Health Threats, in a rapid expert consultation letter to the White House Office of Science and Technology Policy on April 7.

A number of factors could influence whether SARS-CoV-2 follows the same seasonal pattern as the influenza virus and other seasonal coronaviruses, which wane during warmer months, writes Relman, a professor of microbiology and immunology at Stanford University in California.

But he pointed out that previous coronavirus strains that have caused serious illness – SARS-CoV and MERS-CoV – “have not demonstrated any evidence of seasonality following their emergence.”

Relman cites an example from the current outbreak: “Given that countries currently in ‘summer’ climates, such as Australia and Iran, are experiencing rapid virus spread, a decrease in cases with increases in humidity and temperature elsewhere should not be assumed…Additional studies as the pandemic unfolds could shed more light on the effects of climate on transmission,” he writes.

And even if SARS-CoV-2 turns out to be less infectious in warmer months, “given the lack of host immunity globally, this reduction in transmission efficiency may not lead to a significant reduction in disease spread without the concomitant adoption of major public health interventions,” writes Relman.

Conflicting Data

Relman cites a handful of studies indicating that, on the one hand, SARS-CoV-2 has declined with increasing humidity and temperatures, but that conversely, infectivity has increased in warmer, more humid climates.

A recent study in China, published on the repository and international journal site SSRN, found that while increased temperatures and humidity decreased the infectivity, “the average R0 (R naught) was still close to 2 at maximum temperatures and humidity in their data set, suggesting that the virus will still spread exponentially at higher temperatures and humidity,” said Relman.

Several other studies found higher growth rates in temperate regions. One study, still in preprint on MedRxiv, looked at 310 geographic regions across 116 countries, and shows an inverse relationship between temperature and humidity and the incidence of COVID-19.

All the available studies so far have significant limitations, including limitation in time and location, confounding factors having to do with geography, access to and the quality of public health and health care systems, human behavior, and the availability of testing, said Relman.

However, he said, “it is useful to note that pandemic influenza strains have not exhibited the typical seasonal pattern of endemic/epidemic strains,” and, regardless of whether they started in a warmer or a cooler month, “all had a peak second wave approximately six months after the emergence in the human population.”

Worrisome Persistence on Masks

Seasonality can also be potentially gauged in the laboratory. Most of the studies on environmental persistence of SARS-CoV-2 have been conducted using virus grown in tissue culture. But that, too, is an imperfect method.

Virus disseminated into the environment from naturally infected humans likely has different survival properties than virus grown in culture, said Relman.

In addition, many labs cannot, or fail to, control and vary relative humidity, the committee letter noted. The aerosol studies so far have used humidity levels of 50% to 65%, which is more favorable to decay, while respiratory fluid is more likely to protect against infectivity, and the 20%-to-40% wintertime indoor humidity in temperate regions is more favorable for virus survival.

Even with these caveats, the committee cited worrisome studies on SARS-CoV-2 survival.

In a study published April 2 online in The Lancet, Hong Kong researchers reported significant reductions in virus in culture starting with temperatures at 37°C (98.6°F) or above.

On surfaces at a room temperature of 22°C (71.6°F) with a relative humidity of 65%, there was no infectious virus on printing paper or tissue papers after just 3 hours. It took 4 days for an infectious level to break down on glass and money, and 7 days for stainless steel and plastic. But after 7 days, investigators found 0.1% of the original inoculum on the outside of a surgical mask.

“The persistence of infectious virus on PPE is concerning,” writes Relman, noting that more studies are needed to guide healthcare workers, especially on what might be used to disinfect personal protective equipment “when they cannot be discarded after single use.”

Chad Roy, PhD, a researcher from Tulane University National Primate Research Center in New Orleans, Louisiana, told Relman by phone that in experiments where the virus was suspended as an aerosol at a temperature of 23°C (73.4° F) and about 50% humidity, SARS-CoV-2 had a longer half-life than the influenza virus, SARS-CoV-1, monkeypox virus, and Mycobacterium tuberculosis.

“This result is also concerning, but quite preliminary,” writes Relman.

This article first appeared on Medscape.com.

Although conflicting, the available data indicate that SARS-CoV-2 could continue to spread in warmer spring and summer months in the US, according to a new report from the National Academies of Science, Engineering, and Medicine (NAS).

Current data suggest that the novel coronavirus may be transmitted less efficiently in higher temperatures and humidity, but the studies are not conclusive because of poor data quality, confounding factors, and the relatively short existence of the pandemic, which makes it difficult to determine its true course, writes David A. Relman, MD, a member of the NAS’ Standing Committee on Emerging Infectious Diseases and 21st Century Health Threats, in a rapid expert consultation letter to the White House Office of Science and Technology Policy on April 7.

A number of factors could influence whether SARS-CoV-2 follows the same seasonal pattern as the influenza virus and other seasonal coronaviruses, which wane during warmer months, writes Relman, a professor of microbiology and immunology at Stanford University in California.

But he pointed out that previous coronavirus strains that have caused serious illness – SARS-CoV and MERS-CoV – “have not demonstrated any evidence of seasonality following their emergence.”

Relman cites an example from the current outbreak: “Given that countries currently in ‘summer’ climates, such as Australia and Iran, are experiencing rapid virus spread, a decrease in cases with increases in humidity and temperature elsewhere should not be assumed…Additional studies as the pandemic unfolds could shed more light on the effects of climate on transmission,” he writes.

And even if SARS-CoV-2 turns out to be less infectious in warmer months, “given the lack of host immunity globally, this reduction in transmission efficiency may not lead to a significant reduction in disease spread without the concomitant adoption of major public health interventions,” writes Relman.

Conflicting Data

Relman cites a handful of studies indicating that, on the one hand, SARS-CoV-2 has declined with increasing humidity and temperatures, but that conversely, infectivity has increased in warmer, more humid climates.

A recent study in China, published on the repository and international journal site SSRN, found that while increased temperatures and humidity decreased the infectivity, “the average R0 (R naught) was still close to 2 at maximum temperatures and humidity in their data set, suggesting that the virus will still spread exponentially at higher temperatures and humidity,” said Relman.

Several other studies found higher growth rates in temperate regions. One study, still in preprint on MedRxiv, looked at 310 geographic regions across 116 countries, and shows an inverse relationship between temperature and humidity and the incidence of COVID-19.

All the available studies so far have significant limitations, including limitation in time and location, confounding factors having to do with geography, access to and the quality of public health and health care systems, human behavior, and the availability of testing, said Relman.

However, he said, “it is useful to note that pandemic influenza strains have not exhibited the typical seasonal pattern of endemic/epidemic strains,” and, regardless of whether they started in a warmer or a cooler month, “all had a peak second wave approximately six months after the emergence in the human population.”

Worrisome Persistence on Masks

Seasonality can also be potentially gauged in the laboratory. Most of the studies on environmental persistence of SARS-CoV-2 have been conducted using virus grown in tissue culture. But that, too, is an imperfect method.

Virus disseminated into the environment from naturally infected humans likely has different survival properties than virus grown in culture, said Relman.

In addition, many labs cannot, or fail to, control and vary relative humidity, the committee letter noted. The aerosol studies so far have used humidity levels of 50% to 65%, which is more favorable to decay, while respiratory fluid is more likely to protect against infectivity, and the 20%-to-40% wintertime indoor humidity in temperate regions is more favorable for virus survival.

Even with these caveats, the committee cited worrisome studies on SARS-CoV-2 survival.

In a study published April 2 online in The Lancet, Hong Kong researchers reported significant reductions in virus in culture starting with temperatures at 37°C (98.6°F) or above.

On surfaces at a room temperature of 22°C (71.6°F) with a relative humidity of 65%, there was no infectious virus on printing paper or tissue papers after just 3 hours. It took 4 days for an infectious level to break down on glass and money, and 7 days for stainless steel and plastic. But after 7 days, investigators found 0.1% of the original inoculum on the outside of a surgical mask.

“The persistence of infectious virus on PPE is concerning,” writes Relman, noting that more studies are needed to guide healthcare workers, especially on what might be used to disinfect personal protective equipment “when they cannot be discarded after single use.”

Chad Roy, PhD, a researcher from Tulane University National Primate Research Center in New Orleans, Louisiana, told Relman by phone that in experiments where the virus was suspended as an aerosol at a temperature of 23°C (73.4° F) and about 50% humidity, SARS-CoV-2 had a longer half-life than the influenza virus, SARS-CoV-1, monkeypox virus, and Mycobacterium tuberculosis.

“This result is also concerning, but quite preliminary,” writes Relman.

This article first appeared on Medscape.com.

Although conflicting, the available data indicate that SARS-CoV-2 could continue to spread in warmer spring and summer months in the US, according to a new report from the National Academies of Science, Engineering, and Medicine (NAS).

Current data suggest that the novel coronavirus may be transmitted less efficiently in higher temperatures and humidity, but the studies are not conclusive because of poor data quality, confounding factors, and the relatively short existence of the pandemic, which makes it difficult to determine its true course, writes David A. Relman, MD, a member of the NAS’ Standing Committee on Emerging Infectious Diseases and 21st Century Health Threats, in a rapid expert consultation letter to the White House Office of Science and Technology Policy on April 7.

A number of factors could influence whether SARS-CoV-2 follows the same seasonal pattern as the influenza virus and other seasonal coronaviruses, which wane during warmer months, writes Relman, a professor of microbiology and immunology at Stanford University in California.

But he pointed out that previous coronavirus strains that have caused serious illness – SARS-CoV and MERS-CoV – “have not demonstrated any evidence of seasonality following their emergence.”

Relman cites an example from the current outbreak: “Given that countries currently in ‘summer’ climates, such as Australia and Iran, are experiencing rapid virus spread, a decrease in cases with increases in humidity and temperature elsewhere should not be assumed…Additional studies as the pandemic unfolds could shed more light on the effects of climate on transmission,” he writes.

And even if SARS-CoV-2 turns out to be less infectious in warmer months, “given the lack of host immunity globally, this reduction in transmission efficiency may not lead to a significant reduction in disease spread without the concomitant adoption of major public health interventions,” writes Relman.

Conflicting Data

Relman cites a handful of studies indicating that, on the one hand, SARS-CoV-2 has declined with increasing humidity and temperatures, but that conversely, infectivity has increased in warmer, more humid climates.

A recent study in China, published on the repository and international journal site SSRN, found that while increased temperatures and humidity decreased the infectivity, “the average R0 (R naught) was still close to 2 at maximum temperatures and humidity in their data set, suggesting that the virus will still spread exponentially at higher temperatures and humidity,” said Relman.

Several other studies found higher growth rates in temperate regions. One study, still in preprint on MedRxiv, looked at 310 geographic regions across 116 countries, and shows an inverse relationship between temperature and humidity and the incidence of COVID-19.

All the available studies so far have significant limitations, including limitation in time and location, confounding factors having to do with geography, access to and the quality of public health and health care systems, human behavior, and the availability of testing, said Relman.

However, he said, “it is useful to note that pandemic influenza strains have not exhibited the typical seasonal pattern of endemic/epidemic strains,” and, regardless of whether they started in a warmer or a cooler month, “all had a peak second wave approximately six months after the emergence in the human population.”

Worrisome Persistence on Masks

Seasonality can also be potentially gauged in the laboratory. Most of the studies on environmental persistence of SARS-CoV-2 have been conducted using virus grown in tissue culture. But that, too, is an imperfect method.

Virus disseminated into the environment from naturally infected humans likely has different survival properties than virus grown in culture, said Relman.

In addition, many labs cannot, or fail to, control and vary relative humidity, the committee letter noted. The aerosol studies so far have used humidity levels of 50% to 65%, which is more favorable to decay, while respiratory fluid is more likely to protect against infectivity, and the 20%-to-40% wintertime indoor humidity in temperate regions is more favorable for virus survival.

Even with these caveats, the committee cited worrisome studies on SARS-CoV-2 survival.

In a study published April 2 online in The Lancet, Hong Kong researchers reported significant reductions in virus in culture starting with temperatures at 37°C (98.6°F) or above.

On surfaces at a room temperature of 22°C (71.6°F) with a relative humidity of 65%, there was no infectious virus on printing paper or tissue papers after just 3 hours. It took 4 days for an infectious level to break down on glass and money, and 7 days for stainless steel and plastic. But after 7 days, investigators found 0.1% of the original inoculum on the outside of a surgical mask.

“The persistence of infectious virus on PPE is concerning,” writes Relman, noting that more studies are needed to guide healthcare workers, especially on what might be used to disinfect personal protective equipment “when they cannot be discarded after single use.”

Chad Roy, PhD, a researcher from Tulane University National Primate Research Center in New Orleans, Louisiana, told Relman by phone that in experiments where the virus was suspended as an aerosol at a temperature of 23°C (73.4° F) and about 50% humidity, SARS-CoV-2 had a longer half-life than the influenza virus, SARS-CoV-1, monkeypox virus, and Mycobacterium tuberculosis.

“This result is also concerning, but quite preliminary,” writes Relman.

This article first appeared on Medscape.com.