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A new lawsuit alleges that Cigna uses artificial intelligence (AI) algorithms to inappropriately deny “hundreds or thousands” of claims at a time, bypassing legal requirements to complete individual claim reviews and forcing providers to bill patients in full.

In a complaint filed recently in California’s eastern district court, plaintiffs and Cigna health plan members Suzanne Kisting-Leung and Ayesha Smiley and their attorneys say that Cigna violates state insurance regulations by failing to conduct a “thorough, fair, and objective” review of their and other members’ claims.

The lawsuit says that, instead, Cigna relies on an algorithm, PxDx, to review and frequently deny medically necessary claims. According to court records, the system allows Cigna’s doctors to “instantly reject claims on medical grounds without ever opening patient files.” With use of the system, the average claims processing time is 1.2 seconds.

Cigna says it uses technology to verify coding on standard, low-cost procedures and to expedite physician reimbursement. In a statement to CBS News, the company called the lawsuit “highly questionable.”

The case highlights growing concerns about AI and its ability to replace humans for tasks and interactions in health care, business, and beyond. Public advocacy law firm Clarkson, which is representing the plaintiffs, has previously sued tech giants Google and ChatGPT creator OpenAI for harvesting Internet users’ personal and professional data to train their AI systems.

According to the complaint, Cigna denied the plaintiffs medically necessary tests, including blood work to screen for vitamin D deficiency and ultrasounds for patients suspected of having ovarian cancer. The plaintiffs’ attempts to appeal were unfruitful, and they were forced to pay out of pocket.

The plaintiff’s attorneys argue that the claims do not undergo more detailed reviews by physicians and employees, as mandated by California insurance laws, and that Cigna benefits by saving on labor costs.

Clarkson is demanding a jury trial and has asked the court to certify the Cigna case as a federal class action, potentially allowing the insurer’s other 2 million health plan members in California to join the lawsuit.

I. Glenn Cohen, JD, deputy dean and professor at Harvard Law School, Cambridge, Mass., said in an interview that this is the first lawsuit he’s aware of in which AI was involved in denying health insurance claims and that it is probably an uphill battle for the plaintiffs.

“In the last 25 years, the U.S. Supreme Court’s decisions have made getting a class action approved more difficult. If allowed to go forward as a class action, which Cigna is likely to vigorously oppose, then the pressure on Cigna to settle the case becomes enormous,” he said.

The allegations come after a recent deep dive by the nonprofit ProPublica uncovered similar claim denial issues. One physician who worked for Cigna told the nonprofit that he and other company doctors essentially rubber-stamped the denials in batches, which took “all of 10 seconds to do 50 at a time.”

In 2022, the American Medical Association and two state physician groups joined another class action against Cigna stemming from allegations that the insurer’s intermediary, Multiplan, intentionally underpaid medical claims. And in March, Cigna’s pharmacy benefit manager, Express Scripts, was accused of conspiring with other PBMs to drive up prescription drug prices for Ohio consumers, violating state antitrust laws.

Mr. Cohen said he expects Cigna to push back in court about the California class size, which the plaintiff’s attorneys hope will encompass all Cigna health plan members in the state.

“The injury is primarily to those whose claims were denied by AI, presumably a much smaller set of individuals and harder to identify,” said Mr. Cohen.

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

A new lawsuit alleges that Cigna uses artificial intelligence (AI) algorithms to inappropriately deny “hundreds or thousands” of claims at a time, bypassing legal requirements to complete individual claim reviews and forcing providers to bill patients in full.

In a complaint filed recently in California’s eastern district court, plaintiffs and Cigna health plan members Suzanne Kisting-Leung and Ayesha Smiley and their attorneys say that Cigna violates state insurance regulations by failing to conduct a “thorough, fair, and objective” review of their and other members’ claims.

The lawsuit says that, instead, Cigna relies on an algorithm, PxDx, to review and frequently deny medically necessary claims. According to court records, the system allows Cigna’s doctors to “instantly reject claims on medical grounds without ever opening patient files.” With use of the system, the average claims processing time is 1.2 seconds.

Cigna says it uses technology to verify coding on standard, low-cost procedures and to expedite physician reimbursement. In a statement to CBS News, the company called the lawsuit “highly questionable.”

The case highlights growing concerns about AI and its ability to replace humans for tasks and interactions in health care, business, and beyond. Public advocacy law firm Clarkson, which is representing the plaintiffs, has previously sued tech giants Google and ChatGPT creator OpenAI for harvesting Internet users’ personal and professional data to train their AI systems.

According to the complaint, Cigna denied the plaintiffs medically necessary tests, including blood work to screen for vitamin D deficiency and ultrasounds for patients suspected of having ovarian cancer. The plaintiffs’ attempts to appeal were unfruitful, and they were forced to pay out of pocket.

The plaintiff’s attorneys argue that the claims do not undergo more detailed reviews by physicians and employees, as mandated by California insurance laws, and that Cigna benefits by saving on labor costs.

Clarkson is demanding a jury trial and has asked the court to certify the Cigna case as a federal class action, potentially allowing the insurer’s other 2 million health plan members in California to join the lawsuit.

I. Glenn Cohen, JD, deputy dean and professor at Harvard Law School, Cambridge, Mass., said in an interview that this is the first lawsuit he’s aware of in which AI was involved in denying health insurance claims and that it is probably an uphill battle for the plaintiffs.

“In the last 25 years, the U.S. Supreme Court’s decisions have made getting a class action approved more difficult. If allowed to go forward as a class action, which Cigna is likely to vigorously oppose, then the pressure on Cigna to settle the case becomes enormous,” he said.

The allegations come after a recent deep dive by the nonprofit ProPublica uncovered similar claim denial issues. One physician who worked for Cigna told the nonprofit that he and other company doctors essentially rubber-stamped the denials in batches, which took “all of 10 seconds to do 50 at a time.”

In 2022, the American Medical Association and two state physician groups joined another class action against Cigna stemming from allegations that the insurer’s intermediary, Multiplan, intentionally underpaid medical claims. And in March, Cigna’s pharmacy benefit manager, Express Scripts, was accused of conspiring with other PBMs to drive up prescription drug prices for Ohio consumers, violating state antitrust laws.

Mr. Cohen said he expects Cigna to push back in court about the California class size, which the plaintiff’s attorneys hope will encompass all Cigna health plan members in the state.

“The injury is primarily to those whose claims were denied by AI, presumably a much smaller set of individuals and harder to identify,” said Mr. Cohen.

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

A new lawsuit alleges that Cigna uses artificial intelligence (AI) algorithms to inappropriately deny “hundreds or thousands” of claims at a time, bypassing legal requirements to complete individual claim reviews and forcing providers to bill patients in full.

In a complaint filed recently in California’s eastern district court, plaintiffs and Cigna health plan members Suzanne Kisting-Leung and Ayesha Smiley and their attorneys say that Cigna violates state insurance regulations by failing to conduct a “thorough, fair, and objective” review of their and other members’ claims.

The lawsuit says that, instead, Cigna relies on an algorithm, PxDx, to review and frequently deny medically necessary claims. According to court records, the system allows Cigna’s doctors to “instantly reject claims on medical grounds without ever opening patient files.” With use of the system, the average claims processing time is 1.2 seconds.

Cigna says it uses technology to verify coding on standard, low-cost procedures and to expedite physician reimbursement. In a statement to CBS News, the company called the lawsuit “highly questionable.”

The case highlights growing concerns about AI and its ability to replace humans for tasks and interactions in health care, business, and beyond. Public advocacy law firm Clarkson, which is representing the plaintiffs, has previously sued tech giants Google and ChatGPT creator OpenAI for harvesting Internet users’ personal and professional data to train their AI systems.

According to the complaint, Cigna denied the plaintiffs medically necessary tests, including blood work to screen for vitamin D deficiency and ultrasounds for patients suspected of having ovarian cancer. The plaintiffs’ attempts to appeal were unfruitful, and they were forced to pay out of pocket.

The plaintiff’s attorneys argue that the claims do not undergo more detailed reviews by physicians and employees, as mandated by California insurance laws, and that Cigna benefits by saving on labor costs.

Clarkson is demanding a jury trial and has asked the court to certify the Cigna case as a federal class action, potentially allowing the insurer’s other 2 million health plan members in California to join the lawsuit.

I. Glenn Cohen, JD, deputy dean and professor at Harvard Law School, Cambridge, Mass., said in an interview that this is the first lawsuit he’s aware of in which AI was involved in denying health insurance claims and that it is probably an uphill battle for the plaintiffs.

“In the last 25 years, the U.S. Supreme Court’s decisions have made getting a class action approved more difficult. If allowed to go forward as a class action, which Cigna is likely to vigorously oppose, then the pressure on Cigna to settle the case becomes enormous,” he said.

The allegations come after a recent deep dive by the nonprofit ProPublica uncovered similar claim denial issues. One physician who worked for Cigna told the nonprofit that he and other company doctors essentially rubber-stamped the denials in batches, which took “all of 10 seconds to do 50 at a time.”

In 2022, the American Medical Association and two state physician groups joined another class action against Cigna stemming from allegations that the insurer’s intermediary, Multiplan, intentionally underpaid medical claims. And in March, Cigna’s pharmacy benefit manager, Express Scripts, was accused of conspiring with other PBMs to drive up prescription drug prices for Ohio consumers, violating state antitrust laws.

Mr. Cohen said he expects Cigna to push back in court about the California class size, which the plaintiff’s attorneys hope will encompass all Cigna health plan members in the state.

“The injury is primarily to those whose claims were denied by AI, presumably a much smaller set of individuals and harder to identify,” said Mr. Cohen.

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

Deanna Denham Hughes was stunned when she was diagnosed with ovarian cancer in 2022. She was only 32. She had no family history of cancer, and tests found no genetic link. Ms. Hughes wondered why she, an otherwise healthy Black mother of two, would develop a malignancy known as a “silent killer.”

After emergency surgery to remove the mass, along with her ovaries, uterus, fallopian tubes, and appendix, Ms. Hughes said, she saw an Instagram post in which a woman with uterine cancer linked her condition to chemical hair straighteners.

“I almost fell over,” she said from her home in Smyrna, Ga.

When Ms. Hughes was about 4, her mother began applying a chemical straightener, or relaxer, to her hair every 6-8 weeks. “It burned, and it smelled awful,” Ms. Hughes recalled. “But it was just part of our routine to ‘deal with my hair.’ ”

The routine continued until she went to college and met other Black women who wore their hair naturally. Soon, Ms. Hughes quit relaxers.

Social and economic pressures have long compelled Black girls and women to straighten their hair to conform to Eurocentric beauty standards. But chemical straighteners are stinky and costly and sometimes cause painful scalp burns. Mounting evidence now shows they could be a health hazard.

Relaxers can contain carcinogens, such as formaldehyde-releasing agents, phthalates, and other endocrine-disrupting compounds, according to National Institutes of Health studies. The compounds can mimic the body’s hormones and have been linked to breast, uterine, and ovarian cancers, studies show.

African American women’s often frequent and lifelong application of chemical relaxers to their hair and scalp might explain why hormone-related cancers kill disproportionately more Black than White women, say researchers and cancer doctors.

“What’s in these products is harmful,” said Tamarra James-Todd, PhD, an epidemiology professor at Harvard T.H. Chan School of Public Health, Boston, who has studied straightening products for the past 20 years.

She believes manufacturers, policymakers, and physicians should warn consumers that relaxers might cause cancer and other health problems.

But regulators have been slow to act, physicians have been reluctant to take up the cause, and racism continues to dictate fashion standards that make it tough for women to quit relaxers, products so addictive they’re known as “creamy crack.”

Michelle Obama straightened her hair when Barack Obama served as president because she believed Americans were “not ready” to see her in braids, the former first lady said after leaving the White House. The U.S. military still prohibited popular Black hairstyles such as dreadlocks and twists while the nation’s first Black president was in office.

California in 2019 became the first of nearly two dozen states to ban race-based hair discrimination. Last year, the U.S. House of Representatives passed similar legislation, known as the CROWN Act, for Creating a Respectful and Open World for Natural Hair. But the bill failed in the Senate.

The need for legislation underscores the challenges Black girls and women face at school and in the workplace.

“You have to pick your struggles,” said Atlanta-based surgical oncologist Ryland J. Gore, MD. She informs her breast cancer patients about the increased cancer risk from relaxers. Despite her knowledge, however, Dr. Gore continues to use chemical straighteners on her own hair, as she has since she was about 7 years old.

“Your hair tells a story,” she said.

In conversations with patients, Dr. Gore sometimes talks about how African American women once wove messages into their braids about the route to take on the Underground Railroad as they sought freedom from slavery.

“It’s just a deep discussion,” one that touches on culture, history, and research into current hairstyling practices, she said. “The data is out there. So patients should be warned, and then they can make a decision.”

The first hint of a connection between hair products and health issues surfaced in the 1990s. Doctors began seeing signs of sexual maturation in Black babies and young girls who developed breasts and pubic hair after using shampoo containing estrogen or placental extract. When the girls stopped using the shampoo, the hair and breast development receded, according to a study published in the journal Clinical Pediatrics in 1998.

Since then, Dr. James-Todd and other researchers have linked chemicals in hair products to a variety of health issues more prevalent among Black women – from early puberty to preterm birth, obesity, and diabetes.

In recent years, researchers have focused on a possible connection between ingredients in chemical relaxers and hormone-related cancers, like the one Ms. Hughes developed, which tend to be more aggressive and deadly in Black women.

A 2017 study found White women who used chemical relaxers were nearly twice as likely to develop breast cancer as those who did not use them. Because the vast majority of the Black study participants used relaxers, researchers could not effectively test the association in Black women, said lead author Adana Llanos, PhD, associate professor of epidemiology at Columbia University’s Mailman School of Public Health, New York.

Researchers did test it in 2020.

The so-called Sister Study, a landmark National Institute of Environmental Health Sciences investigation into the causes of breast cancer and related diseases, followed 50,000 U.S. women whose sisters had been diagnosed with breast cancer and who were cancer-free when they enrolled. Regardless of race, women who reported using relaxers in the prior year were 18% more likely to be diagnosed with breast cancer. Those who used relaxers at least every 5-8 weeks had a 31% higher breast cancer risk.

Nearly 75% of the Black sisters used relaxers in the prior year, compared with 3% of the non-Hispanic White sisters. Three-quarters of Black women self-reported using the straighteners as adolescents, and frequent use of chemical straighteners during adolescence raised the risk of premenopausal breast cancer, a 2021 NIH-funded study in the International Journal of Cancer found.

Another 2021 analysis of the Sister Study data showed sisters who self-reported that they frequently used relaxers or pressing products doubled their ovarian cancer risk. In 2022, another study found frequent use more than doubled uterine cancer risk.

After researchers discovered the link with uterine cancer, some called for policy changes and other measures to reduce exposure to chemical relaxers.

“It is time to intervene,” Dr. Llanos and her colleagues wrote in a Journal of the National Cancer Institute editorial accompanying the uterine cancer analysis. While acknowledging the need for more research, they issued a “call for action.”

No one can say that using permanent hair straighteners will give you cancer, Dr. Llanos said in an interview. “That’s not how cancer works,” she said, noting that some smokers never develop lung cancer, despite tobacco use being a known risk factor.

The body of research linking hair straighteners and cancer is more limited, said Dr. Llanos, who quit using chemical relaxers 15 years ago. But, she asked rhetorically, “Do we need to do the research for 50 more years to know that chemical relaxers are harmful?”

Charlotte R. Gamble, MD, a gynecological oncologist whose Washington, D.C., practice includes Black women with uterine and ovarian cancer, said she and her colleagues see the uterine cancer study findings as worthy of further exploration – but not yet worthy of discussion with patients.

“The jury’s out for me personally,” she said. “There’s so much more data that’s needed.”

Meanwhile, Dr. James-Todd and other researchers believe they have built a solid body of evidence.

“There are enough things we do know to begin taking action, developing interventions, providing useful information to clinicians and patients and the general public,” said Traci N. Bethea, PhD, assistant professor in the Office of Minority Health and Health Disparities Research at Georgetown University.

Responsibility for regulating personal-care products, including chemical hair straighteners and hair dyes – which also have been linked to hormone-related cancers – lies with the Food and Drug Administration. But the FDA does not subject personal-care products to the same approval process it uses for food and drugs. The FDA restricts only 11 categories of chemicals used in cosmetics, while concerns about health effects have prompted the European Union to restrict the use of at least 2,400 substances.

In March, Reps. Ayanna Pressley (D-Mass.) and Shontel Brown (D-Ohio) asked the FDA to investigate the potential health threat posed by chemical relaxers. An FDA representative said the agency would look into it.

Natural hairstyles are enjoying a resurgence among Black girls and women, but many continue to rely on the creamy crack, said Dede Teteh, DrPH, assistant professor of public health at Chapman University, Irvine, Calif.

She had her first straightening perm at 8 and has struggled to withdraw from relaxers as an adult, said Dr. Teteh, who now wears locs. Not long ago, she considered chemically straightening her hair for an academic job interview because she didn’t want her hair to “be a hindrance” when she appeared before White professors.

Dr. Teteh led “The Cost of Beauty,” a hair-health research project published in 2017. She and her team interviewed 91 Black women in Southern California. Some became “combative” at the idea of quitting relaxers and claimed “everything can cause cancer.”

Their reactions speak to the challenges Black women face in America, Dr. Teteh said.

“It’s not that people do not want to hear the information related to their health,” she said. “But they want people to share the information in a way that it’s really empathetic to the plight of being Black here in the United States.”
 

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF – the independent source for health policy research, polling, and journalism.

Deanna Denham Hughes was stunned when she was diagnosed with ovarian cancer in 2022. She was only 32. She had no family history of cancer, and tests found no genetic link. Ms. Hughes wondered why she, an otherwise healthy Black mother of two, would develop a malignancy known as a “silent killer.”

After emergency surgery to remove the mass, along with her ovaries, uterus, fallopian tubes, and appendix, Ms. Hughes said, she saw an Instagram post in which a woman with uterine cancer linked her condition to chemical hair straighteners.

“I almost fell over,” she said from her home in Smyrna, Ga.

When Ms. Hughes was about 4, her mother began applying a chemical straightener, or relaxer, to her hair every 6-8 weeks. “It burned, and it smelled awful,” Ms. Hughes recalled. “But it was just part of our routine to ‘deal with my hair.’ ”

The routine continued until she went to college and met other Black women who wore their hair naturally. Soon, Ms. Hughes quit relaxers.

Social and economic pressures have long compelled Black girls and women to straighten their hair to conform to Eurocentric beauty standards. But chemical straighteners are stinky and costly and sometimes cause painful scalp burns. Mounting evidence now shows they could be a health hazard.

Relaxers can contain carcinogens, such as formaldehyde-releasing agents, phthalates, and other endocrine-disrupting compounds, according to National Institutes of Health studies. The compounds can mimic the body’s hormones and have been linked to breast, uterine, and ovarian cancers, studies show.

African American women’s often frequent and lifelong application of chemical relaxers to their hair and scalp might explain why hormone-related cancers kill disproportionately more Black than White women, say researchers and cancer doctors.

“What’s in these products is harmful,” said Tamarra James-Todd, PhD, an epidemiology professor at Harvard T.H. Chan School of Public Health, Boston, who has studied straightening products for the past 20 years.

She believes manufacturers, policymakers, and physicians should warn consumers that relaxers might cause cancer and other health problems.

But regulators have been slow to act, physicians have been reluctant to take up the cause, and racism continues to dictate fashion standards that make it tough for women to quit relaxers, products so addictive they’re known as “creamy crack.”

Michelle Obama straightened her hair when Barack Obama served as president because she believed Americans were “not ready” to see her in braids, the former first lady said after leaving the White House. The U.S. military still prohibited popular Black hairstyles such as dreadlocks and twists while the nation’s first Black president was in office.

California in 2019 became the first of nearly two dozen states to ban race-based hair discrimination. Last year, the U.S. House of Representatives passed similar legislation, known as the CROWN Act, for Creating a Respectful and Open World for Natural Hair. But the bill failed in the Senate.

The need for legislation underscores the challenges Black girls and women face at school and in the workplace.

“You have to pick your struggles,” said Atlanta-based surgical oncologist Ryland J. Gore, MD. She informs her breast cancer patients about the increased cancer risk from relaxers. Despite her knowledge, however, Dr. Gore continues to use chemical straighteners on her own hair, as she has since she was about 7 years old.

“Your hair tells a story,” she said.

In conversations with patients, Dr. Gore sometimes talks about how African American women once wove messages into their braids about the route to take on the Underground Railroad as they sought freedom from slavery.

“It’s just a deep discussion,” one that touches on culture, history, and research into current hairstyling practices, she said. “The data is out there. So patients should be warned, and then they can make a decision.”

The first hint of a connection between hair products and health issues surfaced in the 1990s. Doctors began seeing signs of sexual maturation in Black babies and young girls who developed breasts and pubic hair after using shampoo containing estrogen or placental extract. When the girls stopped using the shampoo, the hair and breast development receded, according to a study published in the journal Clinical Pediatrics in 1998.

Since then, Dr. James-Todd and other researchers have linked chemicals in hair products to a variety of health issues more prevalent among Black women – from early puberty to preterm birth, obesity, and diabetes.

In recent years, researchers have focused on a possible connection between ingredients in chemical relaxers and hormone-related cancers, like the one Ms. Hughes developed, which tend to be more aggressive and deadly in Black women.

A 2017 study found White women who used chemical relaxers were nearly twice as likely to develop breast cancer as those who did not use them. Because the vast majority of the Black study participants used relaxers, researchers could not effectively test the association in Black women, said lead author Adana Llanos, PhD, associate professor of epidemiology at Columbia University’s Mailman School of Public Health, New York.

Researchers did test it in 2020.

The so-called Sister Study, a landmark National Institute of Environmental Health Sciences investigation into the causes of breast cancer and related diseases, followed 50,000 U.S. women whose sisters had been diagnosed with breast cancer and who were cancer-free when they enrolled. Regardless of race, women who reported using relaxers in the prior year were 18% more likely to be diagnosed with breast cancer. Those who used relaxers at least every 5-8 weeks had a 31% higher breast cancer risk.

Nearly 75% of the Black sisters used relaxers in the prior year, compared with 3% of the non-Hispanic White sisters. Three-quarters of Black women self-reported using the straighteners as adolescents, and frequent use of chemical straighteners during adolescence raised the risk of premenopausal breast cancer, a 2021 NIH-funded study in the International Journal of Cancer found.

Another 2021 analysis of the Sister Study data showed sisters who self-reported that they frequently used relaxers or pressing products doubled their ovarian cancer risk. In 2022, another study found frequent use more than doubled uterine cancer risk.

After researchers discovered the link with uterine cancer, some called for policy changes and other measures to reduce exposure to chemical relaxers.

“It is time to intervene,” Dr. Llanos and her colleagues wrote in a Journal of the National Cancer Institute editorial accompanying the uterine cancer analysis. While acknowledging the need for more research, they issued a “call for action.”

No one can say that using permanent hair straighteners will give you cancer, Dr. Llanos said in an interview. “That’s not how cancer works,” she said, noting that some smokers never develop lung cancer, despite tobacco use being a known risk factor.

The body of research linking hair straighteners and cancer is more limited, said Dr. Llanos, who quit using chemical relaxers 15 years ago. But, she asked rhetorically, “Do we need to do the research for 50 more years to know that chemical relaxers are harmful?”

Charlotte R. Gamble, MD, a gynecological oncologist whose Washington, D.C., practice includes Black women with uterine and ovarian cancer, said she and her colleagues see the uterine cancer study findings as worthy of further exploration – but not yet worthy of discussion with patients.

“The jury’s out for me personally,” she said. “There’s so much more data that’s needed.”

Meanwhile, Dr. James-Todd and other researchers believe they have built a solid body of evidence.

“There are enough things we do know to begin taking action, developing interventions, providing useful information to clinicians and patients and the general public,” said Traci N. Bethea, PhD, assistant professor in the Office of Minority Health and Health Disparities Research at Georgetown University.

Responsibility for regulating personal-care products, including chemical hair straighteners and hair dyes – which also have been linked to hormone-related cancers – lies with the Food and Drug Administration. But the FDA does not subject personal-care products to the same approval process it uses for food and drugs. The FDA restricts only 11 categories of chemicals used in cosmetics, while concerns about health effects have prompted the European Union to restrict the use of at least 2,400 substances.

In March, Reps. Ayanna Pressley (D-Mass.) and Shontel Brown (D-Ohio) asked the FDA to investigate the potential health threat posed by chemical relaxers. An FDA representative said the agency would look into it.

Natural hairstyles are enjoying a resurgence among Black girls and women, but many continue to rely on the creamy crack, said Dede Teteh, DrPH, assistant professor of public health at Chapman University, Irvine, Calif.

She had her first straightening perm at 8 and has struggled to withdraw from relaxers as an adult, said Dr. Teteh, who now wears locs. Not long ago, she considered chemically straightening her hair for an academic job interview because she didn’t want her hair to “be a hindrance” when she appeared before White professors.

Dr. Teteh led “The Cost of Beauty,” a hair-health research project published in 2017. She and her team interviewed 91 Black women in Southern California. Some became “combative” at the idea of quitting relaxers and claimed “everything can cause cancer.”

Their reactions speak to the challenges Black women face in America, Dr. Teteh said.

“It’s not that people do not want to hear the information related to their health,” she said. “But they want people to share the information in a way that it’s really empathetic to the plight of being Black here in the United States.”
 

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF – the independent source for health policy research, polling, and journalism.

Deanna Denham Hughes was stunned when she was diagnosed with ovarian cancer in 2022. She was only 32. She had no family history of cancer, and tests found no genetic link. Ms. Hughes wondered why she, an otherwise healthy Black mother of two, would develop a malignancy known as a “silent killer.”

After emergency surgery to remove the mass, along with her ovaries, uterus, fallopian tubes, and appendix, Ms. Hughes said, she saw an Instagram post in which a woman with uterine cancer linked her condition to chemical hair straighteners.

“I almost fell over,” she said from her home in Smyrna, Ga.

When Ms. Hughes was about 4, her mother began applying a chemical straightener, or relaxer, to her hair every 6-8 weeks. “It burned, and it smelled awful,” Ms. Hughes recalled. “But it was just part of our routine to ‘deal with my hair.’ ”

The routine continued until she went to college and met other Black women who wore their hair naturally. Soon, Ms. Hughes quit relaxers.

Social and economic pressures have long compelled Black girls and women to straighten their hair to conform to Eurocentric beauty standards. But chemical straighteners are stinky and costly and sometimes cause painful scalp burns. Mounting evidence now shows they could be a health hazard.

Relaxers can contain carcinogens, such as formaldehyde-releasing agents, phthalates, and other endocrine-disrupting compounds, according to National Institutes of Health studies. The compounds can mimic the body’s hormones and have been linked to breast, uterine, and ovarian cancers, studies show.

African American women’s often frequent and lifelong application of chemical relaxers to their hair and scalp might explain why hormone-related cancers kill disproportionately more Black than White women, say researchers and cancer doctors.

“What’s in these products is harmful,” said Tamarra James-Todd, PhD, an epidemiology professor at Harvard T.H. Chan School of Public Health, Boston, who has studied straightening products for the past 20 years.

She believes manufacturers, policymakers, and physicians should warn consumers that relaxers might cause cancer and other health problems.

But regulators have been slow to act, physicians have been reluctant to take up the cause, and racism continues to dictate fashion standards that make it tough for women to quit relaxers, products so addictive they’re known as “creamy crack.”

Michelle Obama straightened her hair when Barack Obama served as president because she believed Americans were “not ready” to see her in braids, the former first lady said after leaving the White House. The U.S. military still prohibited popular Black hairstyles such as dreadlocks and twists while the nation’s first Black president was in office.

California in 2019 became the first of nearly two dozen states to ban race-based hair discrimination. Last year, the U.S. House of Representatives passed similar legislation, known as the CROWN Act, for Creating a Respectful and Open World for Natural Hair. But the bill failed in the Senate.

The need for legislation underscores the challenges Black girls and women face at school and in the workplace.

“You have to pick your struggles,” said Atlanta-based surgical oncologist Ryland J. Gore, MD. She informs her breast cancer patients about the increased cancer risk from relaxers. Despite her knowledge, however, Dr. Gore continues to use chemical straighteners on her own hair, as she has since she was about 7 years old.

“Your hair tells a story,” she said.

In conversations with patients, Dr. Gore sometimes talks about how African American women once wove messages into their braids about the route to take on the Underground Railroad as they sought freedom from slavery.

“It’s just a deep discussion,” one that touches on culture, history, and research into current hairstyling practices, she said. “The data is out there. So patients should be warned, and then they can make a decision.”

The first hint of a connection between hair products and health issues surfaced in the 1990s. Doctors began seeing signs of sexual maturation in Black babies and young girls who developed breasts and pubic hair after using shampoo containing estrogen or placental extract. When the girls stopped using the shampoo, the hair and breast development receded, according to a study published in the journal Clinical Pediatrics in 1998.

Since then, Dr. James-Todd and other researchers have linked chemicals in hair products to a variety of health issues more prevalent among Black women – from early puberty to preterm birth, obesity, and diabetes.

In recent years, researchers have focused on a possible connection between ingredients in chemical relaxers and hormone-related cancers, like the one Ms. Hughes developed, which tend to be more aggressive and deadly in Black women.

A 2017 study found White women who used chemical relaxers were nearly twice as likely to develop breast cancer as those who did not use them. Because the vast majority of the Black study participants used relaxers, researchers could not effectively test the association in Black women, said lead author Adana Llanos, PhD, associate professor of epidemiology at Columbia University’s Mailman School of Public Health, New York.

Researchers did test it in 2020.

The so-called Sister Study, a landmark National Institute of Environmental Health Sciences investigation into the causes of breast cancer and related diseases, followed 50,000 U.S. women whose sisters had been diagnosed with breast cancer and who were cancer-free when they enrolled. Regardless of race, women who reported using relaxers in the prior year were 18% more likely to be diagnosed with breast cancer. Those who used relaxers at least every 5-8 weeks had a 31% higher breast cancer risk.

Nearly 75% of the Black sisters used relaxers in the prior year, compared with 3% of the non-Hispanic White sisters. Three-quarters of Black women self-reported using the straighteners as adolescents, and frequent use of chemical straighteners during adolescence raised the risk of premenopausal breast cancer, a 2021 NIH-funded study in the International Journal of Cancer found.

Another 2021 analysis of the Sister Study data showed sisters who self-reported that they frequently used relaxers or pressing products doubled their ovarian cancer risk. In 2022, another study found frequent use more than doubled uterine cancer risk.

After researchers discovered the link with uterine cancer, some called for policy changes and other measures to reduce exposure to chemical relaxers.

“It is time to intervene,” Dr. Llanos and her colleagues wrote in a Journal of the National Cancer Institute editorial accompanying the uterine cancer analysis. While acknowledging the need for more research, they issued a “call for action.”

No one can say that using permanent hair straighteners will give you cancer, Dr. Llanos said in an interview. “That’s not how cancer works,” she said, noting that some smokers never develop lung cancer, despite tobacco use being a known risk factor.

The body of research linking hair straighteners and cancer is more limited, said Dr. Llanos, who quit using chemical relaxers 15 years ago. But, she asked rhetorically, “Do we need to do the research for 50 more years to know that chemical relaxers are harmful?”

Charlotte R. Gamble, MD, a gynecological oncologist whose Washington, D.C., practice includes Black women with uterine and ovarian cancer, said she and her colleagues see the uterine cancer study findings as worthy of further exploration – but not yet worthy of discussion with patients.

“The jury’s out for me personally,” she said. “There’s so much more data that’s needed.”

Meanwhile, Dr. James-Todd and other researchers believe they have built a solid body of evidence.

“There are enough things we do know to begin taking action, developing interventions, providing useful information to clinicians and patients and the general public,” said Traci N. Bethea, PhD, assistant professor in the Office of Minority Health and Health Disparities Research at Georgetown University.

Responsibility for regulating personal-care products, including chemical hair straighteners and hair dyes – which also have been linked to hormone-related cancers – lies with the Food and Drug Administration. But the FDA does not subject personal-care products to the same approval process it uses for food and drugs. The FDA restricts only 11 categories of chemicals used in cosmetics, while concerns about health effects have prompted the European Union to restrict the use of at least 2,400 substances.

In March, Reps. Ayanna Pressley (D-Mass.) and Shontel Brown (D-Ohio) asked the FDA to investigate the potential health threat posed by chemical relaxers. An FDA representative said the agency would look into it.

Natural hairstyles are enjoying a resurgence among Black girls and women, but many continue to rely on the creamy crack, said Dede Teteh, DrPH, assistant professor of public health at Chapman University, Irvine, Calif.

She had her first straightening perm at 8 and has struggled to withdraw from relaxers as an adult, said Dr. Teteh, who now wears locs. Not long ago, she considered chemically straightening her hair for an academic job interview because she didn’t want her hair to “be a hindrance” when she appeared before White professors.

Dr. Teteh led “The Cost of Beauty,” a hair-health research project published in 2017. She and her team interviewed 91 Black women in Southern California. Some became “combative” at the idea of quitting relaxers and claimed “everything can cause cancer.”

Their reactions speak to the challenges Black women face in America, Dr. Teteh said.

“It’s not that people do not want to hear the information related to their health,” she said. “But they want people to share the information in a way that it’s really empathetic to the plight of being Black here in the United States.”
 

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF – the independent source for health policy research, polling, and journalism.

Most people hear “firm handshake” and automatically think “business world.” A cursory search reveals articles with titles like “Seven Super-Revealing Things Your Handshake Said About You” (Forbes) and “How a Handshake Can Tell You Everything You Need to Know About a Person” (Inc).

Those in the know, however, understand what a handshake really reveals: Current health and vitality. The amount of force that can be generated by the hand is a valid proxy for total-body strength. And total-body strength is one key to healthy aging.

Body temperature, weight, heart rate, and blood pressure inform any patient appointment. Should physicians include grip strength in that group?

Grip-strength testing is easy, fast, and noninvasive. It can be monitored over time. All it requires is a handgrip dynamometer, a tool that may cost less than a stethoscope, and a chair.

“Many studies have looked at strength as a predictor of positive health and weakness as a predictor of negative health outcomes,” said Mark Peterson, PhD, an associate professor at the University of Michigan, Ann Arbor, who’s worked on dozens of those studies.

Among the health risks associated with low grip strength: type 2 diabetes, heart disease, cancer, dementia and Alzheimer’s disease, depression, functional disability, osteoporosis, and premature death from any cause.

The prognostic merits of grip strength have been documented across continents and cultures. Although most of those studies have focused on older adults, they aren’t the only age group researchers have looked at.

“We have several papers on the value of grip strength for predicting diabetes and cardiovascular disease in children and adolescents,” Dr. Peterson said.
 

Survival of the strongest

The first thing to understand about grip-strength testing is that it’s only partially about grip. It’s mostly about strength. That’s what attracted Dr. Peterson to this line of research.

“I’m a former strength coach, so I wanted to make a case for why strength was important across populations, not just athletes,” he said. “I strongly believe in strength preservation and healthy living as a predictor for longevity.”

Consider a classic study of Swedish army recruits. Because of Sweden’s post–World War II conscription policy, virtually every young male in the country underwent a physical examination to see if they were fit for military service – an exam that included a grip-strength test.

That gave the researchers a database with more than a million participants. They followed up on them decades later through publicly available records.

What they found: The men with the weakest grip strength in their late teens were 20% more likely to have died by their mid-50s, compared with those with moderate to high grip strength. Even suicide rates were 20%-30% higher for the weakest recruits.

There’s a brutal Darwinian logic to the idea that a stronger person with a more powerful grip would enjoy a longer, healthier life. To our ancient ancestors, stronger hands meant they were probably better at everything that aided survival: hunting, fighting, building shelter, as well as bearing, transporting, and rearing children.

Fast forward to the 21st century where we must force ourselves to engage in physical activity. The old rules still apply: Strength aids survival.
 

Grip strength and the aging process

Some of the earliest grip-strength studies used it as a proxy for nutritional status in elderly men and women. Nourishment, in turn, predicted their ability to survive an illness or surgery.

Which makes sense; if an older person isn’t eating enough to maintain their health and vitality, their strength would decline. Declining strength would make them more susceptible to infections, hospitalizations, and postsurgical complications, leading to longer hospital stays, loss of independence, and ultimately a higher risk of death from any cause.

Along those lines, Dr. Peterson’s research team at the University of Michigan found that low grip strength is correlated with faster aging at the cellular level.

The study looked at DNA methylation, which Peterson describes as “a reflection of someone’s exposure to life events.”

For example, someone who smokes will have altered methylation patterns, compared with someone who doesn’t. Same with someone who’s had more exposure to environmental pollution.

Accelerated DNA methylation “means you’re essentially at higher risk for what are traditionally considered age-related chronic conditions,” Dr. Peterson said. Those conditions include Alzheimer’s, type 2 diabetes, chronic inflammation, and a higher risk for premature mortality.

Those things are also linked to low grip strength, which is linked to higher DNA methylation and faster biological aging.

But there’s still a missing piece of the puzzle: Why, exactly, would the strength of one’s grip be associated with so many health outcomes?
 

Grip strength and muscle function

“Declining muscle function is the first step of the disabling process,” said Ryan McGrath, PhD, an assistant professor at North Dakota State University, Fargo. “That’s what you can measure with a handgrip test. It helps you identify individuals at risk for the next step of the process, which is declines in physical performance.”

Dr. McGrath got involved in grip-strength research as a postdoctoral fellow at the University of Michigan, where he worked with Peterson. Like his mentor, he’s published multiple studies using data obtained with a handgrip dynamometer.

“It can be a nice tool for assessing muscle function and muscle strength,” he explained. Because the test is so easy to administer – you sit in a chair with your arm at your side and your elbow bent 90 degrees, and squeeze the device as hard as you can – researchers can work with large groups of study participants and come away with statistically powerful data.

“There are a lot of health outcomes it’s associated with,” Dr. McGrath added, “which is one of its greatest strengths and at the same time one of its key limitations.”

He compared the dynamometer with a tire gauge. Just as a tire gauge can alert you to a loss of air pressure without revealing the source of the leak, a dynamometer can’t tell you why your grip strength is deflated.

“It’s hard to specify the prognostic value,” he said. “You don’t know the next steps to take. As a standalone measurement, that’s a concern.”

That’s why his current research goes beyond simple tests of maximum grip strength to more sophisticated measurements of the rate of force development (how fast you can express strength), repeatability (how much your strength declines from your first to your second or third squeeze), and asymmetry (how big a gap there is between your right- and left-hand strength).

Any of those measures could detect a potential neural or neuromuscular issue.

In a 2020 study, for example, Dr. McGrath and his team at NDSU showed that older adults with both weakness and asymmetry in grip-strength tests were nearly four times more likely to experience functional limitations. Those limitations could affect their ability to do anything from routine chores to keeping themselves clean and fed.
 

Waging war on weakness

Using dynamometer readings, the generally accepted cutoffs for low grip strength are 26 kg for an adult male and 16 kg for a female.

But that’s way too simple, Dr. Peterson said.

For one thing, age matters. Grip strength typically peaks for men in their late 20s and declines rapidly in middle age and beyond. For women, it plateaus in their 20s and gently declines until their 50s. So, at minimum, the age-based standards included with a dynamometer should be consulted.

Another caveat: Dr. Peterson said grip strength tests aren’t very meaningful for people who actively train for strength, though he suggests dedicated athletes make up a relatively small percentage of the population – even as low as 10%.

The size of the person taking the test is also important.

“You absolutely must account for body mass in the context of understanding how grip strength, or any strength measure, is reflective of health and function,” Dr. Peterson said.

To calculate strength-weight ratio, which Dr. Peterson calls “normalized grip strength,” divide grip strength in kilograms by body weight in kilograms. For men, a ratio greater than 0.70 puts them in the higher percentiles. For women it’s 0.50.

And if the results suggest that the person in question is objectively weak? “For me, that’s easy,” Dr. Peterson said. “They need to exercise.”

Common sense suggests doing a lot of forearm exercises for grip strength. Not so, said Dr. Peterson. The strength of hand and forearm muscles reflects what they can do along with all other muscles moving together.

A 2019 study found that, for older adults, a variety of exercise programs can lead to modest but meaningful increases in participants’ grip strength – and they don’t necessarily have to include actual gripping exercises. The programs ranged from tai chi to water aerobics to walking, stretching, and all kinds of resistance training.

Dr. Peterson’s advice to everyone is pretty straightforward: Get stronger. It doesn’t really matter how you do it, or how much strength you ultimately gain. Even a little more strength means a little less weakness, and a little more life.

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

Most people hear “firm handshake” and automatically think “business world.” A cursory search reveals articles with titles like “Seven Super-Revealing Things Your Handshake Said About You” (Forbes) and “How a Handshake Can Tell You Everything You Need to Know About a Person” (Inc).

Those in the know, however, understand what a handshake really reveals: Current health and vitality. The amount of force that can be generated by the hand is a valid proxy for total-body strength. And total-body strength is one key to healthy aging.

Body temperature, weight, heart rate, and blood pressure inform any patient appointment. Should physicians include grip strength in that group?

Grip-strength testing is easy, fast, and noninvasive. It can be monitored over time. All it requires is a handgrip dynamometer, a tool that may cost less than a stethoscope, and a chair.

“Many studies have looked at strength as a predictor of positive health and weakness as a predictor of negative health outcomes,” said Mark Peterson, PhD, an associate professor at the University of Michigan, Ann Arbor, who’s worked on dozens of those studies.

Among the health risks associated with low grip strength: type 2 diabetes, heart disease, cancer, dementia and Alzheimer’s disease, depression, functional disability, osteoporosis, and premature death from any cause.

The prognostic merits of grip strength have been documented across continents and cultures. Although most of those studies have focused on older adults, they aren’t the only age group researchers have looked at.

“We have several papers on the value of grip strength for predicting diabetes and cardiovascular disease in children and adolescents,” Dr. Peterson said.
 

Survival of the strongest

The first thing to understand about grip-strength testing is that it’s only partially about grip. It’s mostly about strength. That’s what attracted Dr. Peterson to this line of research.

“I’m a former strength coach, so I wanted to make a case for why strength was important across populations, not just athletes,” he said. “I strongly believe in strength preservation and healthy living as a predictor for longevity.”

Consider a classic study of Swedish army recruits. Because of Sweden’s post–World War II conscription policy, virtually every young male in the country underwent a physical examination to see if they were fit for military service – an exam that included a grip-strength test.

That gave the researchers a database with more than a million participants. They followed up on them decades later through publicly available records.

What they found: The men with the weakest grip strength in their late teens were 20% more likely to have died by their mid-50s, compared with those with moderate to high grip strength. Even suicide rates were 20%-30% higher for the weakest recruits.

There’s a brutal Darwinian logic to the idea that a stronger person with a more powerful grip would enjoy a longer, healthier life. To our ancient ancestors, stronger hands meant they were probably better at everything that aided survival: hunting, fighting, building shelter, as well as bearing, transporting, and rearing children.

Fast forward to the 21st century where we must force ourselves to engage in physical activity. The old rules still apply: Strength aids survival.
 

Grip strength and the aging process

Some of the earliest grip-strength studies used it as a proxy for nutritional status in elderly men and women. Nourishment, in turn, predicted their ability to survive an illness or surgery.

Which makes sense; if an older person isn’t eating enough to maintain their health and vitality, their strength would decline. Declining strength would make them more susceptible to infections, hospitalizations, and postsurgical complications, leading to longer hospital stays, loss of independence, and ultimately a higher risk of death from any cause.

Along those lines, Dr. Peterson’s research team at the University of Michigan found that low grip strength is correlated with faster aging at the cellular level.

The study looked at DNA methylation, which Peterson describes as “a reflection of someone’s exposure to life events.”

For example, someone who smokes will have altered methylation patterns, compared with someone who doesn’t. Same with someone who’s had more exposure to environmental pollution.

Accelerated DNA methylation “means you’re essentially at higher risk for what are traditionally considered age-related chronic conditions,” Dr. Peterson said. Those conditions include Alzheimer’s, type 2 diabetes, chronic inflammation, and a higher risk for premature mortality.

Those things are also linked to low grip strength, which is linked to higher DNA methylation and faster biological aging.

But there’s still a missing piece of the puzzle: Why, exactly, would the strength of one’s grip be associated with so many health outcomes?
 

Grip strength and muscle function

“Declining muscle function is the first step of the disabling process,” said Ryan McGrath, PhD, an assistant professor at North Dakota State University, Fargo. “That’s what you can measure with a handgrip test. It helps you identify individuals at risk for the next step of the process, which is declines in physical performance.”

Dr. McGrath got involved in grip-strength research as a postdoctoral fellow at the University of Michigan, where he worked with Peterson. Like his mentor, he’s published multiple studies using data obtained with a handgrip dynamometer.

“It can be a nice tool for assessing muscle function and muscle strength,” he explained. Because the test is so easy to administer – you sit in a chair with your arm at your side and your elbow bent 90 degrees, and squeeze the device as hard as you can – researchers can work with large groups of study participants and come away with statistically powerful data.

“There are a lot of health outcomes it’s associated with,” Dr. McGrath added, “which is one of its greatest strengths and at the same time one of its key limitations.”

He compared the dynamometer with a tire gauge. Just as a tire gauge can alert you to a loss of air pressure without revealing the source of the leak, a dynamometer can’t tell you why your grip strength is deflated.

“It’s hard to specify the prognostic value,” he said. “You don’t know the next steps to take. As a standalone measurement, that’s a concern.”

That’s why his current research goes beyond simple tests of maximum grip strength to more sophisticated measurements of the rate of force development (how fast you can express strength), repeatability (how much your strength declines from your first to your second or third squeeze), and asymmetry (how big a gap there is between your right- and left-hand strength).

Any of those measures could detect a potential neural or neuromuscular issue.

In a 2020 study, for example, Dr. McGrath and his team at NDSU showed that older adults with both weakness and asymmetry in grip-strength tests were nearly four times more likely to experience functional limitations. Those limitations could affect their ability to do anything from routine chores to keeping themselves clean and fed.
 

Waging war on weakness

Using dynamometer readings, the generally accepted cutoffs for low grip strength are 26 kg for an adult male and 16 kg for a female.

But that’s way too simple, Dr. Peterson said.

For one thing, age matters. Grip strength typically peaks for men in their late 20s and declines rapidly in middle age and beyond. For women, it plateaus in their 20s and gently declines until their 50s. So, at minimum, the age-based standards included with a dynamometer should be consulted.

Another caveat: Dr. Peterson said grip strength tests aren’t very meaningful for people who actively train for strength, though he suggests dedicated athletes make up a relatively small percentage of the population – even as low as 10%.

The size of the person taking the test is also important.

“You absolutely must account for body mass in the context of understanding how grip strength, or any strength measure, is reflective of health and function,” Dr. Peterson said.

To calculate strength-weight ratio, which Dr. Peterson calls “normalized grip strength,” divide grip strength in kilograms by body weight in kilograms. For men, a ratio greater than 0.70 puts them in the higher percentiles. For women it’s 0.50.

And if the results suggest that the person in question is objectively weak? “For me, that’s easy,” Dr. Peterson said. “They need to exercise.”

Common sense suggests doing a lot of forearm exercises for grip strength. Not so, said Dr. Peterson. The strength of hand and forearm muscles reflects what they can do along with all other muscles moving together.

A 2019 study found that, for older adults, a variety of exercise programs can lead to modest but meaningful increases in participants’ grip strength – and they don’t necessarily have to include actual gripping exercises. The programs ranged from tai chi to water aerobics to walking, stretching, and all kinds of resistance training.

Dr. Peterson’s advice to everyone is pretty straightforward: Get stronger. It doesn’t really matter how you do it, or how much strength you ultimately gain. Even a little more strength means a little less weakness, and a little more life.

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

Most people hear “firm handshake” and automatically think “business world.” A cursory search reveals articles with titles like “Seven Super-Revealing Things Your Handshake Said About You” (Forbes) and “How a Handshake Can Tell You Everything You Need to Know About a Person” (Inc).

Those in the know, however, understand what a handshake really reveals: Current health and vitality. The amount of force that can be generated by the hand is a valid proxy for total-body strength. And total-body strength is one key to healthy aging.

Body temperature, weight, heart rate, and blood pressure inform any patient appointment. Should physicians include grip strength in that group?

Grip-strength testing is easy, fast, and noninvasive. It can be monitored over time. All it requires is a handgrip dynamometer, a tool that may cost less than a stethoscope, and a chair.

“Many studies have looked at strength as a predictor of positive health and weakness as a predictor of negative health outcomes,” said Mark Peterson, PhD, an associate professor at the University of Michigan, Ann Arbor, who’s worked on dozens of those studies.

Among the health risks associated with low grip strength: type 2 diabetes, heart disease, cancer, dementia and Alzheimer’s disease, depression, functional disability, osteoporosis, and premature death from any cause.

The prognostic merits of grip strength have been documented across continents and cultures. Although most of those studies have focused on older adults, they aren’t the only age group researchers have looked at.

“We have several papers on the value of grip strength for predicting diabetes and cardiovascular disease in children and adolescents,” Dr. Peterson said.
 

Survival of the strongest

The first thing to understand about grip-strength testing is that it’s only partially about grip. It’s mostly about strength. That’s what attracted Dr. Peterson to this line of research.

“I’m a former strength coach, so I wanted to make a case for why strength was important across populations, not just athletes,” he said. “I strongly believe in strength preservation and healthy living as a predictor for longevity.”

Consider a classic study of Swedish army recruits. Because of Sweden’s post–World War II conscription policy, virtually every young male in the country underwent a physical examination to see if they were fit for military service – an exam that included a grip-strength test.

That gave the researchers a database with more than a million participants. They followed up on them decades later through publicly available records.

What they found: The men with the weakest grip strength in their late teens were 20% more likely to have died by their mid-50s, compared with those with moderate to high grip strength. Even suicide rates were 20%-30% higher for the weakest recruits.

There’s a brutal Darwinian logic to the idea that a stronger person with a more powerful grip would enjoy a longer, healthier life. To our ancient ancestors, stronger hands meant they were probably better at everything that aided survival: hunting, fighting, building shelter, as well as bearing, transporting, and rearing children.

Fast forward to the 21st century where we must force ourselves to engage in physical activity. The old rules still apply: Strength aids survival.
 

Grip strength and the aging process

Some of the earliest grip-strength studies used it as a proxy for nutritional status in elderly men and women. Nourishment, in turn, predicted their ability to survive an illness or surgery.

Which makes sense; if an older person isn’t eating enough to maintain their health and vitality, their strength would decline. Declining strength would make them more susceptible to infections, hospitalizations, and postsurgical complications, leading to longer hospital stays, loss of independence, and ultimately a higher risk of death from any cause.

Along those lines, Dr. Peterson’s research team at the University of Michigan found that low grip strength is correlated with faster aging at the cellular level.

The study looked at DNA methylation, which Peterson describes as “a reflection of someone’s exposure to life events.”

For example, someone who smokes will have altered methylation patterns, compared with someone who doesn’t. Same with someone who’s had more exposure to environmental pollution.

Accelerated DNA methylation “means you’re essentially at higher risk for what are traditionally considered age-related chronic conditions,” Dr. Peterson said. Those conditions include Alzheimer’s, type 2 diabetes, chronic inflammation, and a higher risk for premature mortality.

Those things are also linked to low grip strength, which is linked to higher DNA methylation and faster biological aging.

But there’s still a missing piece of the puzzle: Why, exactly, would the strength of one’s grip be associated with so many health outcomes?
 

Grip strength and muscle function

“Declining muscle function is the first step of the disabling process,” said Ryan McGrath, PhD, an assistant professor at North Dakota State University, Fargo. “That’s what you can measure with a handgrip test. It helps you identify individuals at risk for the next step of the process, which is declines in physical performance.”

Dr. McGrath got involved in grip-strength research as a postdoctoral fellow at the University of Michigan, where he worked with Peterson. Like his mentor, he’s published multiple studies using data obtained with a handgrip dynamometer.

“It can be a nice tool for assessing muscle function and muscle strength,” he explained. Because the test is so easy to administer – you sit in a chair with your arm at your side and your elbow bent 90 degrees, and squeeze the device as hard as you can – researchers can work with large groups of study participants and come away with statistically powerful data.

“There are a lot of health outcomes it’s associated with,” Dr. McGrath added, “which is one of its greatest strengths and at the same time one of its key limitations.”

He compared the dynamometer with a tire gauge. Just as a tire gauge can alert you to a loss of air pressure without revealing the source of the leak, a dynamometer can’t tell you why your grip strength is deflated.

“It’s hard to specify the prognostic value,” he said. “You don’t know the next steps to take. As a standalone measurement, that’s a concern.”

That’s why his current research goes beyond simple tests of maximum grip strength to more sophisticated measurements of the rate of force development (how fast you can express strength), repeatability (how much your strength declines from your first to your second or third squeeze), and asymmetry (how big a gap there is between your right- and left-hand strength).

Any of those measures could detect a potential neural or neuromuscular issue.

In a 2020 study, for example, Dr. McGrath and his team at NDSU showed that older adults with both weakness and asymmetry in grip-strength tests were nearly four times more likely to experience functional limitations. Those limitations could affect their ability to do anything from routine chores to keeping themselves clean and fed.
 

Waging war on weakness

Using dynamometer readings, the generally accepted cutoffs for low grip strength are 26 kg for an adult male and 16 kg for a female.

But that’s way too simple, Dr. Peterson said.

For one thing, age matters. Grip strength typically peaks for men in their late 20s and declines rapidly in middle age and beyond. For women, it plateaus in their 20s and gently declines until their 50s. So, at minimum, the age-based standards included with a dynamometer should be consulted.

Another caveat: Dr. Peterson said grip strength tests aren’t very meaningful for people who actively train for strength, though he suggests dedicated athletes make up a relatively small percentage of the population – even as low as 10%.

The size of the person taking the test is also important.

“You absolutely must account for body mass in the context of understanding how grip strength, or any strength measure, is reflective of health and function,” Dr. Peterson said.

To calculate strength-weight ratio, which Dr. Peterson calls “normalized grip strength,” divide grip strength in kilograms by body weight in kilograms. For men, a ratio greater than 0.70 puts them in the higher percentiles. For women it’s 0.50.

And if the results suggest that the person in question is objectively weak? “For me, that’s easy,” Dr. Peterson said. “They need to exercise.”

Common sense suggests doing a lot of forearm exercises for grip strength. Not so, said Dr. Peterson. The strength of hand and forearm muscles reflects what they can do along with all other muscles moving together.

A 2019 study found that, for older adults, a variety of exercise programs can lead to modest but meaningful increases in participants’ grip strength – and they don’t necessarily have to include actual gripping exercises. The programs ranged from tai chi to water aerobics to walking, stretching, and all kinds of resistance training.

Dr. Peterson’s advice to everyone is pretty straightforward: Get stronger. It doesn’t really matter how you do it, or how much strength you ultimately gain. Even a little more strength means a little less weakness, and a little more life.

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

A popular ingredient in the American diet has been linked to ulcerative colitis. The ingredient is soybean oil, which is very common in processed foods. In fact, U.S. per capita consumption of soybean oil increased more than 1,000-fold during the 20th century.

In a study from the University of California, Riverside, and UC Davis, published in Gut Microbes, mice fed a diet high in soybean oil were more at risk of developing colitis. 

The likely culprit? Linoleic acid, an omega-6 fatty acid that composes up to 60% of soybean oil.

Small amounts of linoleic acid help maintain the body’s water balance. But Americans derive as much as 10% of their daily energy from linoleic acid, when they need only 1%-2%, the researchers say.

The findings build on earlier research linking a high-linoleic acid diet with inflammatory bowel disease, or IBD, in humans. (Previous research in mice has also linked high consumption of the oil with obesity and diabetes in the rodents.)

For the new study, the researchers wanted to drill down into how linoleic acid affects the gut.
 

How linoleic acid may promote inflammation

In mice, the soybean oil diet upset the ratio of omega-3 to omega-6 fatty acids in the gut. This led to a decrease in endocannabinoids, lipid-based molecules that help block inflammation.

Enzymes that metabolize fatty acids are “shared between two pathways,” said study coauthor Frances Sladek, PhD, professor of cell biology at UC Riverside. “If you swamp the system with linoleic acid, you’ll have less enzymes available to metabolize omega-3s into good endocannabinoids.”

The endocannabinoid system has been linked to “visceral pain” in the gut,  said Punyanganie de Silva, MD, MPH, an assistant professor at Brigham & Women’s Hospital, Boston, who was not involved in the study. But the relationship between the endocannabinoid system and inflammation has yet to be fully explored.

“This is one of the first papers that has looked at the association between linoleic acid and the endocannabinoid system,” Dr. de Silva said. “[The researchers] propose a potential new mechanism of how linoleic acid may increase inflammation” – that is, through its impact on the endocannabinoid system. 
 

Changes in the gut microbiome

The gut microbiome of the mice also showed increased amounts of adherent invasive E. coli, a type of bacteria that grows by using linoleic acid as a carbon source. A “very close relative” of this bacteria has been linked to IBD in humans, Dr. Sladek said.

Using a method known as metabolomics, the researchers studied 3,000 metabolites in the intestinal cells of both the mice and the bacteria. Endocannabinoids decreased in both.

“We were actually quite surprised. I didn’t realize that bacteria made endocannabinoids,” Dr. Sladek said.

Helpful bacteria, such as the probiotic lactobacillus species, died off. The mice also had increased levels of oxylipins, which are correlated with obesity in mice and colitis in humans.
 

A high–linoleic acid diet could mean a leaky gut

Linoleic acid binds to a protein known as HNF-4 alpha. Disrupting the expression of this protein can weaken the intestinal barrier, letting toxins flow into the body – more commonly known as leaky gut. Mice on the soybean oil diet had decreased levels of the protein and more porous intestinal barriers, raising the risk for inflammation and colitis. “The HNF-4 alpha protein is conserved from mouse to human, so whatever’s happening to it in the context of the mouse gut, there’s a very high chance that a similar effect could be seen in humans as well,” said study coauthor Poonamjot Deol, PhD, an assistant professional researcher at UC Riverside.

Still, Dr. de Silva urges “some caution when interpreting these results,” given that “this is still experimental and needs to be reproduced in clinical studies as humans have a far more varied microbiome and more variable environmental exposures than these very controlled mouse model studies.”

Dr. de Silva says cooking with olive oil can “help increase omega-3 to omega-6 ratios” and advises eating a varied diet that includes omega-3 fats, such as flaxseed and walnuts, and minimal amounts of processed foods and saturated fats.

Looking ahead, endocannabinoids are being explored as “a potential therapy for treating IBD symptoms,” said Dr. Deol. She hopes to delve further into how linoleic acid affects the endocannabinoid system.

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

A popular ingredient in the American diet has been linked to ulcerative colitis. The ingredient is soybean oil, which is very common in processed foods. In fact, U.S. per capita consumption of soybean oil increased more than 1,000-fold during the 20th century.

In a study from the University of California, Riverside, and UC Davis, published in Gut Microbes, mice fed a diet high in soybean oil were more at risk of developing colitis. 

The likely culprit? Linoleic acid, an omega-6 fatty acid that composes up to 60% of soybean oil.

Small amounts of linoleic acid help maintain the body’s water balance. But Americans derive as much as 10% of their daily energy from linoleic acid, when they need only 1%-2%, the researchers say.

The findings build on earlier research linking a high-linoleic acid diet with inflammatory bowel disease, or IBD, in humans. (Previous research in mice has also linked high consumption of the oil with obesity and diabetes in the rodents.)

For the new study, the researchers wanted to drill down into how linoleic acid affects the gut.
 

How linoleic acid may promote inflammation

In mice, the soybean oil diet upset the ratio of omega-3 to omega-6 fatty acids in the gut. This led to a decrease in endocannabinoids, lipid-based molecules that help block inflammation.

Enzymes that metabolize fatty acids are “shared between two pathways,” said study coauthor Frances Sladek, PhD, professor of cell biology at UC Riverside. “If you swamp the system with linoleic acid, you’ll have less enzymes available to metabolize omega-3s into good endocannabinoids.”

The endocannabinoid system has been linked to “visceral pain” in the gut,  said Punyanganie de Silva, MD, MPH, an assistant professor at Brigham & Women’s Hospital, Boston, who was not involved in the study. But the relationship between the endocannabinoid system and inflammation has yet to be fully explored.

“This is one of the first papers that has looked at the association between linoleic acid and the endocannabinoid system,” Dr. de Silva said. “[The researchers] propose a potential new mechanism of how linoleic acid may increase inflammation” – that is, through its impact on the endocannabinoid system. 
 

Changes in the gut microbiome

The gut microbiome of the mice also showed increased amounts of adherent invasive E. coli, a type of bacteria that grows by using linoleic acid as a carbon source. A “very close relative” of this bacteria has been linked to IBD in humans, Dr. Sladek said.

Using a method known as metabolomics, the researchers studied 3,000 metabolites in the intestinal cells of both the mice and the bacteria. Endocannabinoids decreased in both.

“We were actually quite surprised. I didn’t realize that bacteria made endocannabinoids,” Dr. Sladek said.

Helpful bacteria, such as the probiotic lactobacillus species, died off. The mice also had increased levels of oxylipins, which are correlated with obesity in mice and colitis in humans.
 

A high–linoleic acid diet could mean a leaky gut

Linoleic acid binds to a protein known as HNF-4 alpha. Disrupting the expression of this protein can weaken the intestinal barrier, letting toxins flow into the body – more commonly known as leaky gut. Mice on the soybean oil diet had decreased levels of the protein and more porous intestinal barriers, raising the risk for inflammation and colitis. “The HNF-4 alpha protein is conserved from mouse to human, so whatever’s happening to it in the context of the mouse gut, there’s a very high chance that a similar effect could be seen in humans as well,” said study coauthor Poonamjot Deol, PhD, an assistant professional researcher at UC Riverside.

Still, Dr. de Silva urges “some caution when interpreting these results,” given that “this is still experimental and needs to be reproduced in clinical studies as humans have a far more varied microbiome and more variable environmental exposures than these very controlled mouse model studies.”

Dr. de Silva says cooking with olive oil can “help increase omega-3 to omega-6 ratios” and advises eating a varied diet that includes omega-3 fats, such as flaxseed and walnuts, and minimal amounts of processed foods and saturated fats.

Looking ahead, endocannabinoids are being explored as “a potential therapy for treating IBD symptoms,” said Dr. Deol. She hopes to delve further into how linoleic acid affects the endocannabinoid system.

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

A popular ingredient in the American diet has been linked to ulcerative colitis. The ingredient is soybean oil, which is very common in processed foods. In fact, U.S. per capita consumption of soybean oil increased more than 1,000-fold during the 20th century.

In a study from the University of California, Riverside, and UC Davis, published in Gut Microbes, mice fed a diet high in soybean oil were more at risk of developing colitis. 

The likely culprit? Linoleic acid, an omega-6 fatty acid that composes up to 60% of soybean oil.

Small amounts of linoleic acid help maintain the body’s water balance. But Americans derive as much as 10% of their daily energy from linoleic acid, when they need only 1%-2%, the researchers say.

The findings build on earlier research linking a high-linoleic acid diet with inflammatory bowel disease, or IBD, in humans. (Previous research in mice has also linked high consumption of the oil with obesity and diabetes in the rodents.)

For the new study, the researchers wanted to drill down into how linoleic acid affects the gut.
 

How linoleic acid may promote inflammation

In mice, the soybean oil diet upset the ratio of omega-3 to omega-6 fatty acids in the gut. This led to a decrease in endocannabinoids, lipid-based molecules that help block inflammation.

Enzymes that metabolize fatty acids are “shared between two pathways,” said study coauthor Frances Sladek, PhD, professor of cell biology at UC Riverside. “If you swamp the system with linoleic acid, you’ll have less enzymes available to metabolize omega-3s into good endocannabinoids.”

The endocannabinoid system has been linked to “visceral pain” in the gut,  said Punyanganie de Silva, MD, MPH, an assistant professor at Brigham & Women’s Hospital, Boston, who was not involved in the study. But the relationship between the endocannabinoid system and inflammation has yet to be fully explored.

“This is one of the first papers that has looked at the association between linoleic acid and the endocannabinoid system,” Dr. de Silva said. “[The researchers] propose a potential new mechanism of how linoleic acid may increase inflammation” – that is, through its impact on the endocannabinoid system. 
 

Changes in the gut microbiome

The gut microbiome of the mice also showed increased amounts of adherent invasive E. coli, a type of bacteria that grows by using linoleic acid as a carbon source. A “very close relative” of this bacteria has been linked to IBD in humans, Dr. Sladek said.

Using a method known as metabolomics, the researchers studied 3,000 metabolites in the intestinal cells of both the mice and the bacteria. Endocannabinoids decreased in both.

“We were actually quite surprised. I didn’t realize that bacteria made endocannabinoids,” Dr. Sladek said.

Helpful bacteria, such as the probiotic lactobacillus species, died off. The mice also had increased levels of oxylipins, which are correlated with obesity in mice and colitis in humans.
 

A high–linoleic acid diet could mean a leaky gut

Linoleic acid binds to a protein known as HNF-4 alpha. Disrupting the expression of this protein can weaken the intestinal barrier, letting toxins flow into the body – more commonly known as leaky gut. Mice on the soybean oil diet had decreased levels of the protein and more porous intestinal barriers, raising the risk for inflammation and colitis. “The HNF-4 alpha protein is conserved from mouse to human, so whatever’s happening to it in the context of the mouse gut, there’s a very high chance that a similar effect could be seen in humans as well,” said study coauthor Poonamjot Deol, PhD, an assistant professional researcher at UC Riverside.

Still, Dr. de Silva urges “some caution when interpreting these results,” given that “this is still experimental and needs to be reproduced in clinical studies as humans have a far more varied microbiome and more variable environmental exposures than these very controlled mouse model studies.”

Dr. de Silva says cooking with olive oil can “help increase omega-3 to omega-6 ratios” and advises eating a varied diet that includes omega-3 fats, such as flaxseed and walnuts, and minimal amounts of processed foods and saturated fats.

Looking ahead, endocannabinoids are being explored as “a potential therapy for treating IBD symptoms,” said Dr. Deol. She hopes to delve further into how linoleic acid affects the endocannabinoid system.

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

BALTIMORE – Receiving the first dose of the human papillomavirus (HPV) vaccine at age 9, rather than bundling it with the Tdap and meningitis vaccines, appears to increase the likelihood that children will complete the HPV vaccine series, according to a retrospective cohort study of commercially insured youth presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. The research was published ahead of print in Human Vaccines and Immunotherapeutics.

Changing attitudes

“These findings are novel because they emphasize starting at age 9, and that is different than prior studies that emphasize bundling of these vaccines,” Kevin Ault, MD, professor and chair of the department of obstetrics and gynecology at Western Michigan University Homer Stryker MD School of Medicine and a former member of the CDC’s Advisory Committee on Immunization Practices, said in an interview.

Dr. Ault was not involved in the study but noted that these findings support the AAP’s recommendation to start the HPV vaccine series at age 9. The Centers for Disease Control and Prevention currently recommends giving the first dose of the HPV vaccine at ages 11-12, at the same time as the Tdap and meningitis vaccines. This recommendation to “bundle” the HPV vaccine with the Tdap and meningitis vaccines aims to facilitate provider-family discussion about the HPV vaccine, ideally reducing parent hesitancy and concerns about the vaccines. Multiple studies have shown improved HPV vaccine uptake when providers offer the HPV vaccine at the same time as the Tdap and meningococcal vaccines.

However, shifts in parents’ attitudes have occurred toward the HPV vaccine since those studies on bundling: Concerns about sexual activity have receded while concerns about safety remain high. The American Academy of Pediatrics and the American Cancer Society both advise starting the HPV vaccine series at age 9, based on evidence showing that more children complete the series when they get the first shot before age 11 compared to getting it at 11 or 12.

“The bundling was really to vaccinate people by the age of 13, thinking that onset of sexual activity was after that,” study author Sidika Kajtezovic, MD, a resident at Boston Medical Center and Boston University Obstetrics and Gynecology, said in an interview. But Dr. Kajtezovic said she delivers babies for 13-year-old patients. “Kids are having sex sooner or sooner.” It’s also clear that using the bundling strategy is not making up the entire gap right now: Ninety percent of children are getting the meningococcal vaccine while only 49% are getting the HPV vaccine, Dr. Kajtezovic pointed out. “There’s a disconnect happening there, even with the bundling,” she said.
 

Debundling vaccines

Dr. Kajtezovic and her colleagues used a national database of employee-sponsored health insurance to analyze the records of 100,857 children who were continuously enrolled in a plan from age 9 in 2015 to age 13 in 2019. They calculated the odds of children completing the HPV vaccine series based on whether they started the series before, at the same time as, or after the Tdap vaccination.

Youth who received the HPV vaccine before their Tdap vaccine had 38% greater odds of completing the series – getting both doses – than did those who received the HPV vaccine at the same time as the Tdap vaccine. Meanwhile, in line with prior evidence, those who got the first HPV dose after their Tdap were less likely – 68% lower odds – to complete the two- or three-dose (if starting above age 14) series.

The researchers identified several other factors that were linked to completing the HPV vaccine series. Females had greater odds than did males of completing the series, as did those living in urban, rather than rural, areas. Other factors associated with completing the series included living in the Northeast United States and receiving primary care from a pediatrician rather than a family medicine physician.
 

Timing is important

“I am encouraged by the findings of this study,” Dr. Ault said in an interview. “However, I would have liked the authors to expand the age range a bit higher. There are data that continuing to discuss the HPV vaccine with parents and teens will increase uptake into the later teen years.”

One challenge is that research shows attendance at primary care visits declines in older adolescence. Since there is no second Tdap or meningitis shot, families need to return for the second HPV vaccine dose after those shots, though they could get the second dose at the same time as other two vaccines if they receive the first dose before age 11. There’s also evidence suggesting that providers find conversations about the HPV vaccine easier when sexual activity is not the focus.

“I often feel that, before a child reaches adolescence, they’re almost, in a way, not sexualized yet, so talking about cancer prevention for an 8- or 9-year-old sometimes sounds a little different to patients versus protecting your 12-year-old, who’s starting to go through adolescence and developing breasts” and other signs of puberty, Dr. Kajtezovic said. Keeping the focus of HPV vaccine discussions on cancer prevention also allows providers to point out the protection against anal cancer, vulvar cancer, vaginal cancer, and head and neck cancer. “They are horrible, and even if they’re treatable, they’re often very hard to treat at an advanced stage,” Dr. Kajtezovic said. “The surgery required is so life disabling and disfiguring.”

The HPV Roundtable advises continuing bundling at practices having success with it but encourages practices to consider earlier vaccination if their uptake is lagging. Quality improvement initiatives, such as earlier electronic medical record prompts and multi-level interventions in pediatric practices, have shown substantial increases in HPV vaccine uptake at 9 and 10 years old. One survey in 2021 found that one in five primary care providers already routinely recommend the HPV vaccine at ages 9-10, and nearly half of others would consider doing so.

“My hope is in the next few years, when [the CDC] refreshes their vaccine recommendations, that they will either unbundle it or move the bar a few years earlier so that you can initiate it to encourage earlier initiation,” Dr. Kajtezovic said.

Dr. Ault had no other disclosures besides prior service on ACIP. Dr. Kajtezovic had no disclosures.

BALTIMORE – Receiving the first dose of the human papillomavirus (HPV) vaccine at age 9, rather than bundling it with the Tdap and meningitis vaccines, appears to increase the likelihood that children will complete the HPV vaccine series, according to a retrospective cohort study of commercially insured youth presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. The research was published ahead of print in Human Vaccines and Immunotherapeutics.

Changing attitudes

“These findings are novel because they emphasize starting at age 9, and that is different than prior studies that emphasize bundling of these vaccines,” Kevin Ault, MD, professor and chair of the department of obstetrics and gynecology at Western Michigan University Homer Stryker MD School of Medicine and a former member of the CDC’s Advisory Committee on Immunization Practices, said in an interview.

Dr. Ault was not involved in the study but noted that these findings support the AAP’s recommendation to start the HPV vaccine series at age 9. The Centers for Disease Control and Prevention currently recommends giving the first dose of the HPV vaccine at ages 11-12, at the same time as the Tdap and meningitis vaccines. This recommendation to “bundle” the HPV vaccine with the Tdap and meningitis vaccines aims to facilitate provider-family discussion about the HPV vaccine, ideally reducing parent hesitancy and concerns about the vaccines. Multiple studies have shown improved HPV vaccine uptake when providers offer the HPV vaccine at the same time as the Tdap and meningococcal vaccines.

However, shifts in parents’ attitudes have occurred toward the HPV vaccine since those studies on bundling: Concerns about sexual activity have receded while concerns about safety remain high. The American Academy of Pediatrics and the American Cancer Society both advise starting the HPV vaccine series at age 9, based on evidence showing that more children complete the series when they get the first shot before age 11 compared to getting it at 11 or 12.

“The bundling was really to vaccinate people by the age of 13, thinking that onset of sexual activity was after that,” study author Sidika Kajtezovic, MD, a resident at Boston Medical Center and Boston University Obstetrics and Gynecology, said in an interview. But Dr. Kajtezovic said she delivers babies for 13-year-old patients. “Kids are having sex sooner or sooner.” It’s also clear that using the bundling strategy is not making up the entire gap right now: Ninety percent of children are getting the meningococcal vaccine while only 49% are getting the HPV vaccine, Dr. Kajtezovic pointed out. “There’s a disconnect happening there, even with the bundling,” she said.
 

Debundling vaccines

Dr. Kajtezovic and her colleagues used a national database of employee-sponsored health insurance to analyze the records of 100,857 children who were continuously enrolled in a plan from age 9 in 2015 to age 13 in 2019. They calculated the odds of children completing the HPV vaccine series based on whether they started the series before, at the same time as, or after the Tdap vaccination.

Youth who received the HPV vaccine before their Tdap vaccine had 38% greater odds of completing the series – getting both doses – than did those who received the HPV vaccine at the same time as the Tdap vaccine. Meanwhile, in line with prior evidence, those who got the first HPV dose after their Tdap were less likely – 68% lower odds – to complete the two- or three-dose (if starting above age 14) series.

The researchers identified several other factors that were linked to completing the HPV vaccine series. Females had greater odds than did males of completing the series, as did those living in urban, rather than rural, areas. Other factors associated with completing the series included living in the Northeast United States and receiving primary care from a pediatrician rather than a family medicine physician.
 

Timing is important

“I am encouraged by the findings of this study,” Dr. Ault said in an interview. “However, I would have liked the authors to expand the age range a bit higher. There are data that continuing to discuss the HPV vaccine with parents and teens will increase uptake into the later teen years.”

One challenge is that research shows attendance at primary care visits declines in older adolescence. Since there is no second Tdap or meningitis shot, families need to return for the second HPV vaccine dose after those shots, though they could get the second dose at the same time as other two vaccines if they receive the first dose before age 11. There’s also evidence suggesting that providers find conversations about the HPV vaccine easier when sexual activity is not the focus.

“I often feel that, before a child reaches adolescence, they’re almost, in a way, not sexualized yet, so talking about cancer prevention for an 8- or 9-year-old sometimes sounds a little different to patients versus protecting your 12-year-old, who’s starting to go through adolescence and developing breasts” and other signs of puberty, Dr. Kajtezovic said. Keeping the focus of HPV vaccine discussions on cancer prevention also allows providers to point out the protection against anal cancer, vulvar cancer, vaginal cancer, and head and neck cancer. “They are horrible, and even if they’re treatable, they’re often very hard to treat at an advanced stage,” Dr. Kajtezovic said. “The surgery required is so life disabling and disfiguring.”

The HPV Roundtable advises continuing bundling at practices having success with it but encourages practices to consider earlier vaccination if their uptake is lagging. Quality improvement initiatives, such as earlier electronic medical record prompts and multi-level interventions in pediatric practices, have shown substantial increases in HPV vaccine uptake at 9 and 10 years old. One survey in 2021 found that one in five primary care providers already routinely recommend the HPV vaccine at ages 9-10, and nearly half of others would consider doing so.

“My hope is in the next few years, when [the CDC] refreshes their vaccine recommendations, that they will either unbundle it or move the bar a few years earlier so that you can initiate it to encourage earlier initiation,” Dr. Kajtezovic said.

Dr. Ault had no other disclosures besides prior service on ACIP. Dr. Kajtezovic had no disclosures.

BALTIMORE – Receiving the first dose of the human papillomavirus (HPV) vaccine at age 9, rather than bundling it with the Tdap and meningitis vaccines, appears to increase the likelihood that children will complete the HPV vaccine series, according to a retrospective cohort study of commercially insured youth presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. The research was published ahead of print in Human Vaccines and Immunotherapeutics.

Changing attitudes

“These findings are novel because they emphasize starting at age 9, and that is different than prior studies that emphasize bundling of these vaccines,” Kevin Ault, MD, professor and chair of the department of obstetrics and gynecology at Western Michigan University Homer Stryker MD School of Medicine and a former member of the CDC’s Advisory Committee on Immunization Practices, said in an interview.

Dr. Ault was not involved in the study but noted that these findings support the AAP’s recommendation to start the HPV vaccine series at age 9. The Centers for Disease Control and Prevention currently recommends giving the first dose of the HPV vaccine at ages 11-12, at the same time as the Tdap and meningitis vaccines. This recommendation to “bundle” the HPV vaccine with the Tdap and meningitis vaccines aims to facilitate provider-family discussion about the HPV vaccine, ideally reducing parent hesitancy and concerns about the vaccines. Multiple studies have shown improved HPV vaccine uptake when providers offer the HPV vaccine at the same time as the Tdap and meningococcal vaccines.

However, shifts in parents’ attitudes have occurred toward the HPV vaccine since those studies on bundling: Concerns about sexual activity have receded while concerns about safety remain high. The American Academy of Pediatrics and the American Cancer Society both advise starting the HPV vaccine series at age 9, based on evidence showing that more children complete the series when they get the first shot before age 11 compared to getting it at 11 or 12.

“The bundling was really to vaccinate people by the age of 13, thinking that onset of sexual activity was after that,” study author Sidika Kajtezovic, MD, a resident at Boston Medical Center and Boston University Obstetrics and Gynecology, said in an interview. But Dr. Kajtezovic said she delivers babies for 13-year-old patients. “Kids are having sex sooner or sooner.” It’s also clear that using the bundling strategy is not making up the entire gap right now: Ninety percent of children are getting the meningococcal vaccine while only 49% are getting the HPV vaccine, Dr. Kajtezovic pointed out. “There’s a disconnect happening there, even with the bundling,” she said.
 

Debundling vaccines

Dr. Kajtezovic and her colleagues used a national database of employee-sponsored health insurance to analyze the records of 100,857 children who were continuously enrolled in a plan from age 9 in 2015 to age 13 in 2019. They calculated the odds of children completing the HPV vaccine series based on whether they started the series before, at the same time as, or after the Tdap vaccination.

Youth who received the HPV vaccine before their Tdap vaccine had 38% greater odds of completing the series – getting both doses – than did those who received the HPV vaccine at the same time as the Tdap vaccine. Meanwhile, in line with prior evidence, those who got the first HPV dose after their Tdap were less likely – 68% lower odds – to complete the two- or three-dose (if starting above age 14) series.

The researchers identified several other factors that were linked to completing the HPV vaccine series. Females had greater odds than did males of completing the series, as did those living in urban, rather than rural, areas. Other factors associated with completing the series included living in the Northeast United States and receiving primary care from a pediatrician rather than a family medicine physician.
 

Timing is important

“I am encouraged by the findings of this study,” Dr. Ault said in an interview. “However, I would have liked the authors to expand the age range a bit higher. There are data that continuing to discuss the HPV vaccine with parents and teens will increase uptake into the later teen years.”

One challenge is that research shows attendance at primary care visits declines in older adolescence. Since there is no second Tdap or meningitis shot, families need to return for the second HPV vaccine dose after those shots, though they could get the second dose at the same time as other two vaccines if they receive the first dose before age 11. There’s also evidence suggesting that providers find conversations about the HPV vaccine easier when sexual activity is not the focus.

“I often feel that, before a child reaches adolescence, they’re almost, in a way, not sexualized yet, so talking about cancer prevention for an 8- or 9-year-old sometimes sounds a little different to patients versus protecting your 12-year-old, who’s starting to go through adolescence and developing breasts” and other signs of puberty, Dr. Kajtezovic said. Keeping the focus of HPV vaccine discussions on cancer prevention also allows providers to point out the protection against anal cancer, vulvar cancer, vaginal cancer, and head and neck cancer. “They are horrible, and even if they’re treatable, they’re often very hard to treat at an advanced stage,” Dr. Kajtezovic said. “The surgery required is so life disabling and disfiguring.”

The HPV Roundtable advises continuing bundling at practices having success with it but encourages practices to consider earlier vaccination if their uptake is lagging. Quality improvement initiatives, such as earlier electronic medical record prompts and multi-level interventions in pediatric practices, have shown substantial increases in HPV vaccine uptake at 9 and 10 years old. One survey in 2021 found that one in five primary care providers already routinely recommend the HPV vaccine at ages 9-10, and nearly half of others would consider doing so.

“My hope is in the next few years, when [the CDC] refreshes their vaccine recommendations, that they will either unbundle it or move the bar a few years earlier so that you can initiate it to encourage earlier initiation,” Dr. Kajtezovic said.

Dr. Ault had no other disclosures besides prior service on ACIP. Dr. Kajtezovic had no disclosures.

Skin reactions at insulin pump infusion sites are common among people with type 1 diabetes who use the devices and can lead to delivery failure, new research suggests.
 

Insulin pump use is increasingly common, but many patients experience infusion-site failure that in some cases leads to discontinuation. In a novel investigation, researchers at the University of Washington, Seattle, used biopsies and noninvasive imaging to compare insulin pump sites with control sites in 30 patients. Several differences were found at pump sites in comparison with control sites, including fibrosis, inflammation, eosinophils, and increased vessel density.

“These findings support allergic sensitization as a potentially common reaction at [insulin pump] sites. The leading candidates causing this include insulin preservatives, plastic materials, and adhesive glue used in device manufacturing,” wrote Andrea Kalus, MD, of the university’s dermatology division, and colleagues. The findings were published recently in Diabetes Care.

The inflammatory response, they wrote, “may result in tissue changes responsible for the infusion-site failures seen frequently in clinical practice.”

Such infusion site problems represent an “Achilles heel” of these otherwise highly beneficial devices, lead author Irl Hirsch, MD, professor of medicine in the division of metabolism, endocrinology, and nutrition, said in a statement. “It doesn’t really matter how good the technology is. We still don’t understand what is happening with the infusion sites, much less to [be able to] fix it.”
 

Significant differences between pump and nonpump sites

In the cross-sectional study, Dr. Kalus and colleagues used noninvasive optical coherence tomography (OCT) immediately prior to performing punch biopsies at three sites: the site currently in active use, the “recovery site” used 3-5 days prior to the procedures, and control sites never used for pump infusion. Punch biopsies were also performed at those sites.

The mean age of the patients was 48.3 years, the mean diabetes duration was 30.4 years, and the mean duration of pump use was 15.8 years. Nearly all patients (93.3%) reported itchiness at the site, and 76.7% reported skin redness.

Of the 25 patients for whom OCT imaging was successful, statistical analysis showed significant differences in vascular area density and the optical attenuation coefficient, a surrogate for skin inflammation, between the pump and control sites and between recovery sites and current pump sites. The greater vessel density is likely a result of injury and repair related to catheter insertion, the authors said.

In the biopsy samples, both current and recovery sites showed increased fibrosis, fibrin, inflammation, fat necrosis, vascularity, and eosinophils, compared with the control sites, but no significant differences were found between current and recovery sites.

Eosinophils: ‘The most surprising histologic finding’

Eosinophils were found in 73% of skin biopsy specimens from current sites and in 75% of specimens from recovery sites, compared with none from the control sites (for both, P < .01). In all study participants, eosinophils were found in at least one current and/or recovery infusion site deep in the dermis near the interface with fat. The number of eosinophils ranged from 0 to 31 per high-power field, with a median of 4.

The number of eosinophils didn’t vary by type of insulin or brand of pump, but higher counts were seen in those who had used pumps for less than 10 years, compared with more than 20 years (P = .02).

The prevalence and degree of eosinophils were “the most surprising histologic finding,” the authors wrote, adding that “eosinophils are not typically present as a component of resident inflammatory cells in the skin.”

While eosinophils may be present in normal wound healing, “the absolute number and density of eosinophil in these samples support a delayed-type hypersensitivity response, which is typically observed between 2 and 7 days after exposure to an allergen. ... Eosinophils are often correlated with symptoms of itchiness and likely explain the high percentage of participants who reported itchiness in this study,” Dr. Kalus and colleagues wrote.
 

Correlation found between inflammation and glycemic control

All participants used the Dexcom G6 continuous glucose monitor as part of their usual care. Inflammation scores were positively correlated with insulin dose (P = .009) and were negatively correlated with time in range (P = .01).

No other OCT or biopsy findings differed by duration of pump use, previous use of animal insulin, or type of insulin.

The reason for these findings is unclear, Dr. Hirsch said. “How much was the catheter or the insulin causing the irritation around the sites? How much was it from the preservatives, or is this because of the insulin pump itself? All these questions need to be answered in future studies. ... The real goal of all of this is to minimize skin damage and improve the experience for our patients.”

The study was funded by the Leona M. and Harry B. Helmsley Charitable Trust. Dr. Hirsch reported grants and contracts from Insulet, Medtronic, and Dexcom outside the submitted work; consulting fees from Abbott Diabetes Care, Lifescan, and Hagar outside the submitted work; and honoraria for lectures, presentations, participation on speaker’s bureaus, manuscript writing, or educational events as section editor for UpToDate outside the submitted work. Dr. Kalus has no disclosures.

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

Skin reactions at insulin pump infusion sites are common among people with type 1 diabetes who use the devices and can lead to delivery failure, new research suggests.
 

Insulin pump use is increasingly common, but many patients experience infusion-site failure that in some cases leads to discontinuation. In a novel investigation, researchers at the University of Washington, Seattle, used biopsies and noninvasive imaging to compare insulin pump sites with control sites in 30 patients. Several differences were found at pump sites in comparison with control sites, including fibrosis, inflammation, eosinophils, and increased vessel density.

“These findings support allergic sensitization as a potentially common reaction at [insulin pump] sites. The leading candidates causing this include insulin preservatives, plastic materials, and adhesive glue used in device manufacturing,” wrote Andrea Kalus, MD, of the university’s dermatology division, and colleagues. The findings were published recently in Diabetes Care.

The inflammatory response, they wrote, “may result in tissue changes responsible for the infusion-site failures seen frequently in clinical practice.”

Such infusion site problems represent an “Achilles heel” of these otherwise highly beneficial devices, lead author Irl Hirsch, MD, professor of medicine in the division of metabolism, endocrinology, and nutrition, said in a statement. “It doesn’t really matter how good the technology is. We still don’t understand what is happening with the infusion sites, much less to [be able to] fix it.”
 

Significant differences between pump and nonpump sites

In the cross-sectional study, Dr. Kalus and colleagues used noninvasive optical coherence tomography (OCT) immediately prior to performing punch biopsies at three sites: the site currently in active use, the “recovery site” used 3-5 days prior to the procedures, and control sites never used for pump infusion. Punch biopsies were also performed at those sites.

The mean age of the patients was 48.3 years, the mean diabetes duration was 30.4 years, and the mean duration of pump use was 15.8 years. Nearly all patients (93.3%) reported itchiness at the site, and 76.7% reported skin redness.

Of the 25 patients for whom OCT imaging was successful, statistical analysis showed significant differences in vascular area density and the optical attenuation coefficient, a surrogate for skin inflammation, between the pump and control sites and between recovery sites and current pump sites. The greater vessel density is likely a result of injury and repair related to catheter insertion, the authors said.

In the biopsy samples, both current and recovery sites showed increased fibrosis, fibrin, inflammation, fat necrosis, vascularity, and eosinophils, compared with the control sites, but no significant differences were found between current and recovery sites.

Eosinophils: ‘The most surprising histologic finding’

Eosinophils were found in 73% of skin biopsy specimens from current sites and in 75% of specimens from recovery sites, compared with none from the control sites (for both, P < .01). In all study participants, eosinophils were found in at least one current and/or recovery infusion site deep in the dermis near the interface with fat. The number of eosinophils ranged from 0 to 31 per high-power field, with a median of 4.

The number of eosinophils didn’t vary by type of insulin or brand of pump, but higher counts were seen in those who had used pumps for less than 10 years, compared with more than 20 years (P = .02).

The prevalence and degree of eosinophils were “the most surprising histologic finding,” the authors wrote, adding that “eosinophils are not typically present as a component of resident inflammatory cells in the skin.”

While eosinophils may be present in normal wound healing, “the absolute number and density of eosinophil in these samples support a delayed-type hypersensitivity response, which is typically observed between 2 and 7 days after exposure to an allergen. ... Eosinophils are often correlated with symptoms of itchiness and likely explain the high percentage of participants who reported itchiness in this study,” Dr. Kalus and colleagues wrote.
 

Correlation found between inflammation and glycemic control

All participants used the Dexcom G6 continuous glucose monitor as part of their usual care. Inflammation scores were positively correlated with insulin dose (P = .009) and were negatively correlated with time in range (P = .01).

No other OCT or biopsy findings differed by duration of pump use, previous use of animal insulin, or type of insulin.

The reason for these findings is unclear, Dr. Hirsch said. “How much was the catheter or the insulin causing the irritation around the sites? How much was it from the preservatives, or is this because of the insulin pump itself? All these questions need to be answered in future studies. ... The real goal of all of this is to minimize skin damage and improve the experience for our patients.”

The study was funded by the Leona M. and Harry B. Helmsley Charitable Trust. Dr. Hirsch reported grants and contracts from Insulet, Medtronic, and Dexcom outside the submitted work; consulting fees from Abbott Diabetes Care, Lifescan, and Hagar outside the submitted work; and honoraria for lectures, presentations, participation on speaker’s bureaus, manuscript writing, or educational events as section editor for UpToDate outside the submitted work. Dr. Kalus has no disclosures.

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

Skin reactions at insulin pump infusion sites are common among people with type 1 diabetes who use the devices and can lead to delivery failure, new research suggests.
 

Insulin pump use is increasingly common, but many patients experience infusion-site failure that in some cases leads to discontinuation. In a novel investigation, researchers at the University of Washington, Seattle, used biopsies and noninvasive imaging to compare insulin pump sites with control sites in 30 patients. Several differences were found at pump sites in comparison with control sites, including fibrosis, inflammation, eosinophils, and increased vessel density.

“These findings support allergic sensitization as a potentially common reaction at [insulin pump] sites. The leading candidates causing this include insulin preservatives, plastic materials, and adhesive glue used in device manufacturing,” wrote Andrea Kalus, MD, of the university’s dermatology division, and colleagues. The findings were published recently in Diabetes Care.

The inflammatory response, they wrote, “may result in tissue changes responsible for the infusion-site failures seen frequently in clinical practice.”

Such infusion site problems represent an “Achilles heel” of these otherwise highly beneficial devices, lead author Irl Hirsch, MD, professor of medicine in the division of metabolism, endocrinology, and nutrition, said in a statement. “It doesn’t really matter how good the technology is. We still don’t understand what is happening with the infusion sites, much less to [be able to] fix it.”
 

Significant differences between pump and nonpump sites

In the cross-sectional study, Dr. Kalus and colleagues used noninvasive optical coherence tomography (OCT) immediately prior to performing punch biopsies at three sites: the site currently in active use, the “recovery site” used 3-5 days prior to the procedures, and control sites never used for pump infusion. Punch biopsies were also performed at those sites.

The mean age of the patients was 48.3 years, the mean diabetes duration was 30.4 years, and the mean duration of pump use was 15.8 years. Nearly all patients (93.3%) reported itchiness at the site, and 76.7% reported skin redness.

Of the 25 patients for whom OCT imaging was successful, statistical analysis showed significant differences in vascular area density and the optical attenuation coefficient, a surrogate for skin inflammation, between the pump and control sites and between recovery sites and current pump sites. The greater vessel density is likely a result of injury and repair related to catheter insertion, the authors said.

In the biopsy samples, both current and recovery sites showed increased fibrosis, fibrin, inflammation, fat necrosis, vascularity, and eosinophils, compared with the control sites, but no significant differences were found between current and recovery sites.

Eosinophils: ‘The most surprising histologic finding’

Eosinophils were found in 73% of skin biopsy specimens from current sites and in 75% of specimens from recovery sites, compared with none from the control sites (for both, P < .01). In all study participants, eosinophils were found in at least one current and/or recovery infusion site deep in the dermis near the interface with fat. The number of eosinophils ranged from 0 to 31 per high-power field, with a median of 4.

The number of eosinophils didn’t vary by type of insulin or brand of pump, but higher counts were seen in those who had used pumps for less than 10 years, compared with more than 20 years (P = .02).

The prevalence and degree of eosinophils were “the most surprising histologic finding,” the authors wrote, adding that “eosinophils are not typically present as a component of resident inflammatory cells in the skin.”

While eosinophils may be present in normal wound healing, “the absolute number and density of eosinophil in these samples support a delayed-type hypersensitivity response, which is typically observed between 2 and 7 days after exposure to an allergen. ... Eosinophils are often correlated with symptoms of itchiness and likely explain the high percentage of participants who reported itchiness in this study,” Dr. Kalus and colleagues wrote.
 

Correlation found between inflammation and glycemic control

All participants used the Dexcom G6 continuous glucose monitor as part of their usual care. Inflammation scores were positively correlated with insulin dose (P = .009) and were negatively correlated with time in range (P = .01).

No other OCT or biopsy findings differed by duration of pump use, previous use of animal insulin, or type of insulin.

The reason for these findings is unclear, Dr. Hirsch said. “How much was the catheter or the insulin causing the irritation around the sites? How much was it from the preservatives, or is this because of the insulin pump itself? All these questions need to be answered in future studies. ... The real goal of all of this is to minimize skin damage and improve the experience for our patients.”

The study was funded by the Leona M. and Harry B. Helmsley Charitable Trust. Dr. Hirsch reported grants and contracts from Insulet, Medtronic, and Dexcom outside the submitted work; consulting fees from Abbott Diabetes Care, Lifescan, and Hagar outside the submitted work; and honoraria for lectures, presentations, participation on speaker’s bureaus, manuscript writing, or educational events as section editor for UpToDate outside the submitted work. Dr. Kalus has no disclosures.

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

In patients aged 2-11 years, roflumilast cream was well tolerated and improved signs and symptoms of psoriasis over 4 weeks, according to results from a pair of phase two studies.

“Limited topical treatments are approved for children younger than 12 years old with psoriasis,” researchers led by Adelaide A. Hebert, MD, wrote in their abstract. The results were presented during a poster session at the annual meeting of the Society for Pediatric Dermatology.

Roflumilast cream 0.3% (Zoryve) is a once-daily, topical nonsteroidal treatment from Arcutis Biotherapeutics. A phosphodiesterase-4 inhibitor, it was approved by the Food and Drug Administration in 2022 for mild, moderate and severe psoriasis in individuals aged 12 and older, including intertriginous psoriasis.

For the analysis, Dr. Hebert, chief of pediatric dermatology at the University of Texas, Houston, and colleagues conducted two 4-week, phase 2, open-label safety studies of roflumilast cream 0.3%.

One, study 216, enrolled 10 children aged 2-5, and all but one were Black. The other, study 215, enrolled 20 children aged 6-11, and half were Black and nearly half were White. At baseline, patients had 2% or greater body surface area (BSA) involvement and an Investigator Global Assessment (IGA) score of at least mild.

Caregivers applied roflumilast cream to all affected areas once daily for 28 days. The researchers collected pharmacokinetic samples at week 2 and week 4. The primary endpoints were pharmacokinetic, safety, and tolerability.

Efficacy was evaluated as exploratory endpoints: An IGA of clear or almost clear plus a 2-grade or more improvement from baseline, a 50% or greater improvement and a 75% or greater improvement on the Psoriasis Area and Severity Index (PASI-50 and PASI-75), a 4-point or greater reduction in the Worst Itch–Numeric Rating Scale (WI-NRS) in patients with a baseline score of 4 or greater, a mean change from baseline in BSA, and improvement in the Children’s Dermatology Life Quality Index (CDLQI).

At baseline, the mean BSA was similar for patients enrolled in studies 216 and 215 (9.6% and 8.8%, respectively), and 80% of all patients had baseline IGA of moderate. By week 2, the mean roflumilast and N-oxide predose plasma concentrations among patients in the younger group were 2.15 and 22.4 ng/mL, compared with 3.15 and 28.9 ng/mL among those in the older group. At week 4, the mean roflumilast and N-oxide predose concentrations were 2.04 and 15.8 ng/mL in the younger group (study 216), compared with 1.68 and 15.7 ng/mL in the older group (study 215).

As for efficacy, 90% and 40% of patients in studies 216 and 215 achieved IGA success at week 4, respectively, while 90% and 50% achieved PASI-75, 90% and 40% achieved WI-NRS success, and the mean BSA reductions at week 4 were 79.1% and 44.4%. Meanwhile, one younger patient in study 216 reported a treatment-emergent adverse event (TEAE) of headache, which was considered mild, while four older patients in study 215 reported 8 TEAEs, which were considered mild and ranged from back pain to nasal congestion.

“The rapid onset of action was surprising but exceedingly rewarding for the subjects enrolled in the study,” Dr. Hebert told this news organization after the meeting. “The PASI scores and itch scores were markedly improved at the end of the 4-week clinical trial. Patient and parents alike were pleased to use a steroid-free option with once-daily application and rapid onset of action to help control plaque psoriasis.”

In the poster abstract, she and her coauthors concluded that “under maximal use conditions in children aged 2-11 years, roflumilast cream 0.3% was well tolerated and improved signs and symptoms of psoriasis with measured improvements in IGA score, PASI score, BSA involvement, CDLQI, and WI-NRS. Overall, pharmacokinetics, safety, tolerability, and efficacy in patients aged 2-11 years were consistent with prior results in adults and adolescents.”

The study was funded by Arcutis Biotherapeutics. Dr. Hebert reported that she is an investigator for Arcutis. About half the coauthors are employees of Arcutis, and the other half disclosed grants, research funding and/or honoraria from the company. Research grants from the company for this study were paid to the McGovern Medical School at the University of Texas.

In patients aged 2-11 years, roflumilast cream was well tolerated and improved signs and symptoms of psoriasis over 4 weeks, according to results from a pair of phase two studies.

“Limited topical treatments are approved for children younger than 12 years old with psoriasis,” researchers led by Adelaide A. Hebert, MD, wrote in their abstract. The results were presented during a poster session at the annual meeting of the Society for Pediatric Dermatology.

Roflumilast cream 0.3% (Zoryve) is a once-daily, topical nonsteroidal treatment from Arcutis Biotherapeutics. A phosphodiesterase-4 inhibitor, it was approved by the Food and Drug Administration in 2022 for mild, moderate and severe psoriasis in individuals aged 12 and older, including intertriginous psoriasis.

For the analysis, Dr. Hebert, chief of pediatric dermatology at the University of Texas, Houston, and colleagues conducted two 4-week, phase 2, open-label safety studies of roflumilast cream 0.3%.

One, study 216, enrolled 10 children aged 2-5, and all but one were Black. The other, study 215, enrolled 20 children aged 6-11, and half were Black and nearly half were White. At baseline, patients had 2% or greater body surface area (BSA) involvement and an Investigator Global Assessment (IGA) score of at least mild.

Caregivers applied roflumilast cream to all affected areas once daily for 28 days. The researchers collected pharmacokinetic samples at week 2 and week 4. The primary endpoints were pharmacokinetic, safety, and tolerability.

Efficacy was evaluated as exploratory endpoints: An IGA of clear or almost clear plus a 2-grade or more improvement from baseline, a 50% or greater improvement and a 75% or greater improvement on the Psoriasis Area and Severity Index (PASI-50 and PASI-75), a 4-point or greater reduction in the Worst Itch–Numeric Rating Scale (WI-NRS) in patients with a baseline score of 4 or greater, a mean change from baseline in BSA, and improvement in the Children’s Dermatology Life Quality Index (CDLQI).

At baseline, the mean BSA was similar for patients enrolled in studies 216 and 215 (9.6% and 8.8%, respectively), and 80% of all patients had baseline IGA of moderate. By week 2, the mean roflumilast and N-oxide predose plasma concentrations among patients in the younger group were 2.15 and 22.4 ng/mL, compared with 3.15 and 28.9 ng/mL among those in the older group. At week 4, the mean roflumilast and N-oxide predose concentrations were 2.04 and 15.8 ng/mL in the younger group (study 216), compared with 1.68 and 15.7 ng/mL in the older group (study 215).

As for efficacy, 90% and 40% of patients in studies 216 and 215 achieved IGA success at week 4, respectively, while 90% and 50% achieved PASI-75, 90% and 40% achieved WI-NRS success, and the mean BSA reductions at week 4 were 79.1% and 44.4%. Meanwhile, one younger patient in study 216 reported a treatment-emergent adverse event (TEAE) of headache, which was considered mild, while four older patients in study 215 reported 8 TEAEs, which were considered mild and ranged from back pain to nasal congestion.

“The rapid onset of action was surprising but exceedingly rewarding for the subjects enrolled in the study,” Dr. Hebert told this news organization after the meeting. “The PASI scores and itch scores were markedly improved at the end of the 4-week clinical trial. Patient and parents alike were pleased to use a steroid-free option with once-daily application and rapid onset of action to help control plaque psoriasis.”

In the poster abstract, she and her coauthors concluded that “under maximal use conditions in children aged 2-11 years, roflumilast cream 0.3% was well tolerated and improved signs and symptoms of psoriasis with measured improvements in IGA score, PASI score, BSA involvement, CDLQI, and WI-NRS. Overall, pharmacokinetics, safety, tolerability, and efficacy in patients aged 2-11 years were consistent with prior results in adults and adolescents.”

The study was funded by Arcutis Biotherapeutics. Dr. Hebert reported that she is an investigator for Arcutis. About half the coauthors are employees of Arcutis, and the other half disclosed grants, research funding and/or honoraria from the company. Research grants from the company for this study were paid to the McGovern Medical School at the University of Texas.

In patients aged 2-11 years, roflumilast cream was well tolerated and improved signs and symptoms of psoriasis over 4 weeks, according to results from a pair of phase two studies.

“Limited topical treatments are approved for children younger than 12 years old with psoriasis,” researchers led by Adelaide A. Hebert, MD, wrote in their abstract. The results were presented during a poster session at the annual meeting of the Society for Pediatric Dermatology.

Roflumilast cream 0.3% (Zoryve) is a once-daily, topical nonsteroidal treatment from Arcutis Biotherapeutics. A phosphodiesterase-4 inhibitor, it was approved by the Food and Drug Administration in 2022 for mild, moderate and severe psoriasis in individuals aged 12 and older, including intertriginous psoriasis.

For the analysis, Dr. Hebert, chief of pediatric dermatology at the University of Texas, Houston, and colleagues conducted two 4-week, phase 2, open-label safety studies of roflumilast cream 0.3%.

One, study 216, enrolled 10 children aged 2-5, and all but one were Black. The other, study 215, enrolled 20 children aged 6-11, and half were Black and nearly half were White. At baseline, patients had 2% or greater body surface area (BSA) involvement and an Investigator Global Assessment (IGA) score of at least mild.

Caregivers applied roflumilast cream to all affected areas once daily for 28 days. The researchers collected pharmacokinetic samples at week 2 and week 4. The primary endpoints were pharmacokinetic, safety, and tolerability.

Efficacy was evaluated as exploratory endpoints: An IGA of clear or almost clear plus a 2-grade or more improvement from baseline, a 50% or greater improvement and a 75% or greater improvement on the Psoriasis Area and Severity Index (PASI-50 and PASI-75), a 4-point or greater reduction in the Worst Itch–Numeric Rating Scale (WI-NRS) in patients with a baseline score of 4 or greater, a mean change from baseline in BSA, and improvement in the Children’s Dermatology Life Quality Index (CDLQI).

At baseline, the mean BSA was similar for patients enrolled in studies 216 and 215 (9.6% and 8.8%, respectively), and 80% of all patients had baseline IGA of moderate. By week 2, the mean roflumilast and N-oxide predose plasma concentrations among patients in the younger group were 2.15 and 22.4 ng/mL, compared with 3.15 and 28.9 ng/mL among those in the older group. At week 4, the mean roflumilast and N-oxide predose concentrations were 2.04 and 15.8 ng/mL in the younger group (study 216), compared with 1.68 and 15.7 ng/mL in the older group (study 215).

As for efficacy, 90% and 40% of patients in studies 216 and 215 achieved IGA success at week 4, respectively, while 90% and 50% achieved PASI-75, 90% and 40% achieved WI-NRS success, and the mean BSA reductions at week 4 were 79.1% and 44.4%. Meanwhile, one younger patient in study 216 reported a treatment-emergent adverse event (TEAE) of headache, which was considered mild, while four older patients in study 215 reported 8 TEAEs, which were considered mild and ranged from back pain to nasal congestion.

“The rapid onset of action was surprising but exceedingly rewarding for the subjects enrolled in the study,” Dr. Hebert told this news organization after the meeting. “The PASI scores and itch scores were markedly improved at the end of the 4-week clinical trial. Patient and parents alike were pleased to use a steroid-free option with once-daily application and rapid onset of action to help control plaque psoriasis.”

In the poster abstract, she and her coauthors concluded that “under maximal use conditions in children aged 2-11 years, roflumilast cream 0.3% was well tolerated and improved signs and symptoms of psoriasis with measured improvements in IGA score, PASI score, BSA involvement, CDLQI, and WI-NRS. Overall, pharmacokinetics, safety, tolerability, and efficacy in patients aged 2-11 years were consistent with prior results in adults and adolescents.”

The study was funded by Arcutis Biotherapeutics. Dr. Hebert reported that she is an investigator for Arcutis. About half the coauthors are employees of Arcutis, and the other half disclosed grants, research funding and/or honoraria from the company. Research grants from the company for this study were paid to the McGovern Medical School at the University of Texas.

Who owns your genes? The assumption of any sane person would be that he or she owns his or her own genes. I mean, how dumb a question is that?
 

Yet, in 2007, Dov Michaeli, MD, PhD, described how an American company had claimed ownership of genetic materials and believed that it had the right to commercialize those naturally occurring bits of DNA. Myriad Genetics began by patenting mutations of BRCA. Dr. Michaeli issued a call for action to support early efforts to pass legislation to restore and preserve individual ownership of one’s own genes. This is a historically important quick read/watch/listen. Give it a click.

In related legislation, the Genetic Information Nondiscrimination Act (GINA), originally introduced by New York Rep. Louise Slaughter in 1995, was ultimately spearheaded by California Rep. Xavier Becerra (now Secretary of Health & Human Services) to passage by the House of Representatives on April 25, 2007, by a vote of 420-9-3. Led by Sen. Edward Kennedy of Massachusetts, it was passed by the Senate on April 24, 2008, by a vote of 95-0. President George W. Bush signed the bill into law on May 21, 2008.

GINA is a landmark piece of legislation that protects Americans. It prohibits employers and health insurers from discriminating against people on the basis of their genetic information, and it also prohibits the use of genetic information in life insurance and long-term care insurance.

Its impact has been immense. GINA has been indispensable in promoting progress in the field of human genetics. By safeguarding individuals against discrimination based on genetic information, it has encouraged broader participation in research, built public trust, and stimulated advancements in genetic testing and personalized medicine. GINA’s impact extends beyond borders and has influenced much of the rest of the world.

As important as GINA was to the field, more was needed. National legislation to protect ownership of genetic materials has, despite many attempts, still not become law in the United States. However, in our system of divided government and balance of power, we also have independent courts.

June 13, 2023, was the 10th anniversary of another landmark event. The legal case is that of the Association for Molecular Pathology v. Myriad Genetics, a Salt Lake City–based biotech company that held patents on isolated DNA sequences associated with breast and ovarian cancer. The AMP, joined by several other organizations and researchers, challenged Myriad’s gene patents, arguing that human genes are naturally occurring and, therefore, should not be subject to patenting. In a unanimous decision, the Supreme Court held that naturally occurring DNA segments are products of nature and therefore are not eligible for patent protection.

This was a pivotal decision in the field of human genetics and had a broad impact on genetic research. The decision clarified that naturally occurring DNA sequences cannot be patented, which means that researchers are free to use these sequences in their research without fear of patent infringement. This has led to a vast increase in the amount of genetic research being conducted, and it has also led to the development of new genetic tests and treatments.

The numbers of genetic research papers published in scientific journals and of genetic tests available to consumers have increased significantly, while the cost of genetic testing has decreased significantly. The AMP v. Myriad decision is likely to continue to have an impact for many years to come.

In 2023, Americans do own their own genes and can feel secure in them not being used against us. Thank you, common sense, activist American molecular pathologists, Congress, the President, and the Supreme Court for siding with the people.Dr. Lundbert is editor in chief of Cancer Commons. He has disclosed no relevant financial relationships.

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

Who owns your genes? The assumption of any sane person would be that he or she owns his or her own genes. I mean, how dumb a question is that?
 

Yet, in 2007, Dov Michaeli, MD, PhD, described how an American company had claimed ownership of genetic materials and believed that it had the right to commercialize those naturally occurring bits of DNA. Myriad Genetics began by patenting mutations of BRCA. Dr. Michaeli issued a call for action to support early efforts to pass legislation to restore and preserve individual ownership of one’s own genes. This is a historically important quick read/watch/listen. Give it a click.

In related legislation, the Genetic Information Nondiscrimination Act (GINA), originally introduced by New York Rep. Louise Slaughter in 1995, was ultimately spearheaded by California Rep. Xavier Becerra (now Secretary of Health & Human Services) to passage by the House of Representatives on April 25, 2007, by a vote of 420-9-3. Led by Sen. Edward Kennedy of Massachusetts, it was passed by the Senate on April 24, 2008, by a vote of 95-0. President George W. Bush signed the bill into law on May 21, 2008.

GINA is a landmark piece of legislation that protects Americans. It prohibits employers and health insurers from discriminating against people on the basis of their genetic information, and it also prohibits the use of genetic information in life insurance and long-term care insurance.

Its impact has been immense. GINA has been indispensable in promoting progress in the field of human genetics. By safeguarding individuals against discrimination based on genetic information, it has encouraged broader participation in research, built public trust, and stimulated advancements in genetic testing and personalized medicine. GINA’s impact extends beyond borders and has influenced much of the rest of the world.

As important as GINA was to the field, more was needed. National legislation to protect ownership of genetic materials has, despite many attempts, still not become law in the United States. However, in our system of divided government and balance of power, we also have independent courts.

June 13, 2023, was the 10th anniversary of another landmark event. The legal case is that of the Association for Molecular Pathology v. Myriad Genetics, a Salt Lake City–based biotech company that held patents on isolated DNA sequences associated with breast and ovarian cancer. The AMP, joined by several other organizations and researchers, challenged Myriad’s gene patents, arguing that human genes are naturally occurring and, therefore, should not be subject to patenting. In a unanimous decision, the Supreme Court held that naturally occurring DNA segments are products of nature and therefore are not eligible for patent protection.

This was a pivotal decision in the field of human genetics and had a broad impact on genetic research. The decision clarified that naturally occurring DNA sequences cannot be patented, which means that researchers are free to use these sequences in their research without fear of patent infringement. This has led to a vast increase in the amount of genetic research being conducted, and it has also led to the development of new genetic tests and treatments.

The numbers of genetic research papers published in scientific journals and of genetic tests available to consumers have increased significantly, while the cost of genetic testing has decreased significantly. The AMP v. Myriad decision is likely to continue to have an impact for many years to come.

In 2023, Americans do own their own genes and can feel secure in them not being used against us. Thank you, common sense, activist American molecular pathologists, Congress, the President, and the Supreme Court for siding with the people.Dr. Lundbert is editor in chief of Cancer Commons. He has disclosed no relevant financial relationships.

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

Who owns your genes? The assumption of any sane person would be that he or she owns his or her own genes. I mean, how dumb a question is that?
 

Yet, in 2007, Dov Michaeli, MD, PhD, described how an American company had claimed ownership of genetic materials and believed that it had the right to commercialize those naturally occurring bits of DNA. Myriad Genetics began by patenting mutations of BRCA. Dr. Michaeli issued a call for action to support early efforts to pass legislation to restore and preserve individual ownership of one’s own genes. This is a historically important quick read/watch/listen. Give it a click.

In related legislation, the Genetic Information Nondiscrimination Act (GINA), originally introduced by New York Rep. Louise Slaughter in 1995, was ultimately spearheaded by California Rep. Xavier Becerra (now Secretary of Health & Human Services) to passage by the House of Representatives on April 25, 2007, by a vote of 420-9-3. Led by Sen. Edward Kennedy of Massachusetts, it was passed by the Senate on April 24, 2008, by a vote of 95-0. President George W. Bush signed the bill into law on May 21, 2008.

GINA is a landmark piece of legislation that protects Americans. It prohibits employers and health insurers from discriminating against people on the basis of their genetic information, and it also prohibits the use of genetic information in life insurance and long-term care insurance.

Its impact has been immense. GINA has been indispensable in promoting progress in the field of human genetics. By safeguarding individuals against discrimination based on genetic information, it has encouraged broader participation in research, built public trust, and stimulated advancements in genetic testing and personalized medicine. GINA’s impact extends beyond borders and has influenced much of the rest of the world.

As important as GINA was to the field, more was needed. National legislation to protect ownership of genetic materials has, despite many attempts, still not become law in the United States. However, in our system of divided government and balance of power, we also have independent courts.

June 13, 2023, was the 10th anniversary of another landmark event. The legal case is that of the Association for Molecular Pathology v. Myriad Genetics, a Salt Lake City–based biotech company that held patents on isolated DNA sequences associated with breast and ovarian cancer. The AMP, joined by several other organizations and researchers, challenged Myriad’s gene patents, arguing that human genes are naturally occurring and, therefore, should not be subject to patenting. In a unanimous decision, the Supreme Court held that naturally occurring DNA segments are products of nature and therefore are not eligible for patent protection.

This was a pivotal decision in the field of human genetics and had a broad impact on genetic research. The decision clarified that naturally occurring DNA sequences cannot be patented, which means that researchers are free to use these sequences in their research without fear of patent infringement. This has led to a vast increase in the amount of genetic research being conducted, and it has also led to the development of new genetic tests and treatments.

The numbers of genetic research papers published in scientific journals and of genetic tests available to consumers have increased significantly, while the cost of genetic testing has decreased significantly. The AMP v. Myriad decision is likely to continue to have an impact for many years to come.

In 2023, Americans do own their own genes and can feel secure in them not being used against us. Thank you, common sense, activist American molecular pathologists, Congress, the President, and the Supreme Court for siding with the people.Dr. Lundbert is editor in chief of Cancer Commons. He has disclosed no relevant financial relationships.

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

A multicenter, international phase 2 trial known as EDELIFE is underway to investigate the safety and efficacy of an in utero treatment for developing males with X-linked hypohidrotic ectodermal dysplasia (XLHED).

This condition is caused by mutations in the gene coding for ectodysplasin A (EDA), a protein that signals the epithelial-mesenchymal transition during embryogenesis. EDA loss or dysfunction precludes binding to its endogenous EDA1 receptor (EDAR), and downstream development of teeth, hair, nails, and skin adnexae, most notably eccrine glands.

shironosov/Getty Images

The treatment, ER004, is a first-in-class signaling protein EDA replacement molecule now under investigation by the EspeRare Foundation, with support from the Pierre Fabre Foundation. The pioneering clinical trial is evaluating the delivery of ER004 protein replacement in utero to affected fetuses, allowing antenatal binding to the EDAR. According to the EDELIFE web site, when ER004 is administered to XLHED-affected males in utero, it “should act as a replacement for the missing EDA and trigger the process that leads to the normal development of a baby’s skin, teeth, hair, and sweat glands, leading to better formation of these structures.”

The protein is delivered into the amniotic fluid via a needle and syringe under ultrasound guidance. In a report on this treatment used in a pair of affected twins and a third XLHED-affected male published in 2018, the authors reported that the three babies were able to sweat normally after birth, “and XLHED-related illness had not developed by 14-22 months of age.”

The goal of the prospective, open-label, genotype match–controlled EDELIFE trial is to confirm the efficacy and safety results for ER004 in a larger group of boys, and to determine if it can lead to robust, and long-lasting improvement in XLHED-associated defects.

In the United States, the first pregnant woman to join the study received the treatment in February 2023 at Washington University in St. Louis. Other clinical sites are located in France, Germany, Italy, Spain, and the United Kingdom. Led by principal investigator Holm Schneider, MD, of the University Erlanger-Nurnberg (Germany), researchers are seeking to enroll mothers aged 18 years and older who are genetically confirmed carriers of the XLHED mutation and pregnant with a boy or considering pregnancy. The control group will include XLHED-affected males, 6 months to 60 years old, who are blood relatives of the pregnant woman participating in the study.

Clinicians treating affected families or potentially eligible subjects are encouraged to contact the trial investigators at this link.

A multicenter, international phase 2 trial known as EDELIFE is underway to investigate the safety and efficacy of an in utero treatment for developing males with X-linked hypohidrotic ectodermal dysplasia (XLHED).

This condition is caused by mutations in the gene coding for ectodysplasin A (EDA), a protein that signals the epithelial-mesenchymal transition during embryogenesis. EDA loss or dysfunction precludes binding to its endogenous EDA1 receptor (EDAR), and downstream development of teeth, hair, nails, and skin adnexae, most notably eccrine glands.

shironosov/Getty Images

The treatment, ER004, is a first-in-class signaling protein EDA replacement molecule now under investigation by the EspeRare Foundation, with support from the Pierre Fabre Foundation. The pioneering clinical trial is evaluating the delivery of ER004 protein replacement in utero to affected fetuses, allowing antenatal binding to the EDAR. According to the EDELIFE web site, when ER004 is administered to XLHED-affected males in utero, it “should act as a replacement for the missing EDA and trigger the process that leads to the normal development of a baby’s skin, teeth, hair, and sweat glands, leading to better formation of these structures.”

The protein is delivered into the amniotic fluid via a needle and syringe under ultrasound guidance. In a report on this treatment used in a pair of affected twins and a third XLHED-affected male published in 2018, the authors reported that the three babies were able to sweat normally after birth, “and XLHED-related illness had not developed by 14-22 months of age.”

The goal of the prospective, open-label, genotype match–controlled EDELIFE trial is to confirm the efficacy and safety results for ER004 in a larger group of boys, and to determine if it can lead to robust, and long-lasting improvement in XLHED-associated defects.

In the United States, the first pregnant woman to join the study received the treatment in February 2023 at Washington University in St. Louis. Other clinical sites are located in France, Germany, Italy, Spain, and the United Kingdom. Led by principal investigator Holm Schneider, MD, of the University Erlanger-Nurnberg (Germany), researchers are seeking to enroll mothers aged 18 years and older who are genetically confirmed carriers of the XLHED mutation and pregnant with a boy or considering pregnancy. The control group will include XLHED-affected males, 6 months to 60 years old, who are blood relatives of the pregnant woman participating in the study.

Clinicians treating affected families or potentially eligible subjects are encouraged to contact the trial investigators at this link.

A multicenter, international phase 2 trial known as EDELIFE is underway to investigate the safety and efficacy of an in utero treatment for developing males with X-linked hypohidrotic ectodermal dysplasia (XLHED).

This condition is caused by mutations in the gene coding for ectodysplasin A (EDA), a protein that signals the epithelial-mesenchymal transition during embryogenesis. EDA loss or dysfunction precludes binding to its endogenous EDA1 receptor (EDAR), and downstream development of teeth, hair, nails, and skin adnexae, most notably eccrine glands.

shironosov/Getty Images

The treatment, ER004, is a first-in-class signaling protein EDA replacement molecule now under investigation by the EspeRare Foundation, with support from the Pierre Fabre Foundation. The pioneering clinical trial is evaluating the delivery of ER004 protein replacement in utero to affected fetuses, allowing antenatal binding to the EDAR. According to the EDELIFE web site, when ER004 is administered to XLHED-affected males in utero, it “should act as a replacement for the missing EDA and trigger the process that leads to the normal development of a baby’s skin, teeth, hair, and sweat glands, leading to better formation of these structures.”

The protein is delivered into the amniotic fluid via a needle and syringe under ultrasound guidance. In a report on this treatment used in a pair of affected twins and a third XLHED-affected male published in 2018, the authors reported that the three babies were able to sweat normally after birth, “and XLHED-related illness had not developed by 14-22 months of age.”

The goal of the prospective, open-label, genotype match–controlled EDELIFE trial is to confirm the efficacy and safety results for ER004 in a larger group of boys, and to determine if it can lead to robust, and long-lasting improvement in XLHED-associated defects.

In the United States, the first pregnant woman to join the study received the treatment in February 2023 at Washington University in St. Louis. Other clinical sites are located in France, Germany, Italy, Spain, and the United Kingdom. Led by principal investigator Holm Schneider, MD, of the University Erlanger-Nurnberg (Germany), researchers are seeking to enroll mothers aged 18 years and older who are genetically confirmed carriers of the XLHED mutation and pregnant with a boy or considering pregnancy. The control group will include XLHED-affected males, 6 months to 60 years old, who are blood relatives of the pregnant woman participating in the study.

Clinicians treating affected families or potentially eligible subjects are encouraged to contact the trial investigators at this link.

Outsourcing certain staff functions in a practice to outside contractors working in remote locations has become commonplace in many medical practices.

Health care outsourcing services, also known as virtual assistants (VAs), were already booming in 2017, when volume grew by 36%. Then, the COVID-19 pandemic in 2020 normalized off-site work, which was a boon to outsourcing providers.

The most popular services being outsourced today by medical practices include billing, scribes, telephone calls to patients, and processing prior authorizations.

“Outsourcing is not for everyone, but I’ve seen it work for many practices,” said Lara Hochman, MD, a practice management consultant in Austin, Tex. She said that practices have used outsourcing to solve problems like high staff turnover, tight budgets, and inefficient use of staff.

When in-house staffing is insufficient or not appropriately aligned with the task, outsourcing can produce big savings, said Teri Deabler, a practice management consultant with the Texas Medical Association.

For example, she said that a client was paying an in-house accountant $80,000 a year. When the accountant retired, she was replaced with a part-time bookkeeper earning $20,000 while her accounting work was outsourced at a cost of $20,000 a year. “The practice’s costs for this service were cut in half,” Ms. Deabler said.
 

What functions lend themselves to outsourcing?

Clinical services are rarely outsourced by individual practices – although hospitals now outsource numerous clinical services – but virtually any kind of administrative service can be contracted out. Outsourcing used to be limited mainly to billing and off-hours phone services, but today, more services are available, such as scribing, processing prior authorizations, accounting and bookkeeping, human resources (HR) and payroll, interactions with social media, recredentialing, medical transcription, and marketing.

Meanwhile, the original outsourced services have evolved. Billing and collections may now be handled by off-shore VAs, and phone services now deal with a wider variety of tasks, such as answering patients’ questions, scheduling appointments, and making referrals.

Ron Holder, chief operating officer of Medical Group Management Association in Englewood, Colo., said that some outsourcing services can also adjust the amount of work provided based on the customer’s needs. “For instance, an IT outsourcer may allow you to scale up IT support for a new big tech project, such as installing a new electronic health record,” he said.

The outsourced service provider, who might work in another state or another country, is connected to the practice by phone and electronically, and represents the practice when dealing with patients, insurers, or other vendors.

“No one, including patients and your physicians, should know that they are dealing with an outsourced company,” said Mr. Holder. “The work, look, and feel of the outsourced functions should be seamless. Employees at the outsourcer should always identify themselves as the practice, not the outsourcing service.”

Dr. Hochman said that many outsourcing companies dedicate a particular worker to a particular practice and train them to work there. One example of this approach is Provider’s Choice Scribe Services, based in San Antonio. On its website, the company notes that each scribe is paired with a doctor and learns his or her documentation preferences, EMR use, and charting requirements.
 

What medical practices benefit most from outsourcing?

All kinds and sizes of practices contract with outsourcing firms, but the arrangement is particularly useful for smaller practices, Mr. Holder said. “Larger practices have the economies of scale that allow services to be in-house,” he said, “but smaller practices don’t have that opportunity.”

Dr. Hochman added that outsourcing firms can be hired part-time when the practice doesn’t have enough work for a full-time position. Alternatively, a full-time outsourcing firm can perform two or more separate tasks, such as scribing while handling prior authorizations, she said.

Outsourcing is also useful for new practices, Ms. Deabler said. “A new practice is not earning much money, so it has to have a bare-bones staff,” she said. “Billing, for example, should be contracted out, but it won’t cost that much, because the outsourcer typically charges by volume, and the volume in a new practice is low.”

Meanwhile, Mr. Holder said that the outsourcing of prior authorization work can particularly benefit specialty practices because they typically have a lot of prior authorizations to deal with.
 

The pros and cons of outsourcing

Experts with experience in outsourcing agree there are both pluses and minuses. “Practices with outsourced workers have less overhead, don’t have to deal with staff turnover, and costs may be lower than for in-house staff,” Ms. Deabler said. “However, you have limited control over outsourced workers and the practice may seem more anonymous to patients, so you need to consider this option very carefully.”

“With outsourcing, you lose control,” said John Machata, MD, a recently retired solo family physician in Wickford, R.I. “You’re trusting someone else to do work that you could do anyway.”

When he briefly considered outsourcing the practice’s billing many years ago, he found that billing companies wouldn’t handle bills that took a lot of work, such as getting in touch with the insurance company and explaining the patient’s situation. “They would only handle the easy bills, which the practice could do anyway,” he said.

However, he does think that answering services may be useful to outsource. “Patients are more inclined to call an anonymous entity than the doctor,” he said. When he gave patients his cell phone number, he said that some patients held off from calling because they didn’t want to bother him.

“Outsourced staff should be less expensive than in-house staff,” said Daniel Shay, an attorney at Gosfield & Associates in Philadelphia. “On the other hand, you are liable for the outsourcer’s mistakes. If your outsourced billing company is upcoding claims, your practice would be on the hook for repayment and penalties.”

Mr. Holder said: “An outsourcer ought to be more efficient at its chosen task because that is what they know how to do. This is a plus at a small practice, where the practice manager may need to do the billing, HR, IT, marketing, some legal work, and accounting,” he said. “No one person can do all of those things well.”

He added, however, “If you choose outsourcing and then decide you don’t like it, it’s difficult to unwind the arrangement. Staff that have been dismissed can’t easily be hired back, so it shouldn’t be an easy decision to make.”

Also, sometimes the staff at offshore outsourcing firms may have accents that are harder for patients to understand, and the offshore staff may not readily understand a U.S. caller. However, Dr. Hochman said that practices often have a chance to interview and select specific persons on the offshore team who best fit their needs.
 

Offshore outsourcing

Outsourcing firms have been moving abroad, where costs are lower. Typical venues are India and the Philippines because there are larger percentages of people who speak English. Since 2020, demand at offshore medical billing companies has been growing faster than their domestic counterparts, according to a recent analysis.

The difference in price can be substantial. In 2020, the average salary for scribes in India was $500 a month, compared with $2,500 for scribes in the United States.

However, offshore outsourcing is starting to face limitations in some places because of privacy issues, according to David J. Zetter, a practice management consultant in Mechanicsburg, Pa. He pointed to a new Florida law that limits use of offshore vendors because they deal with confidential patient information. The law, which became effective July 1, requires that any protected health information must be maintained in the United States or Canada.

“This will make it very hard for many types of offshore vendors to operate in Florida,” he said. He noted that Florida is the only state with such a restriction, but similar proposals are under consideration in a few other states, such as Texas.
 

How to select the right company

Mr. Zetter said that the biggest mistake practices make when choosing a company is failing to take enough time to examine their choice. “Quite often, practices don’t validate that companies know what they are doing,” he said. “They get a recommendation and go with it.”

“Choose a company with experience in your specialty,” Mr. Zetter advised. “Speak with the company’s clients, not just the ones the company gives you to speak to. You should ask for the full list of clients and speak to all of them.”

Ms. Deabler said that it’s fairly easy to find respected outsourcing companies. “Colleagues can make recommendations, state and specialty societies can provide lists of preferred vendors, and you can visit vendors’ booths at medical conferences,” she said. She added that it’s also easy to find evaluations of each company. “You can Google the company and come up with all kinds of information about it,” she said.

Mr. Shay said that practices should make sure they understand the terms of the contract with a VA. “Depending on how the contract is worded, you may be stuck with the relationship for many years,” he said. “Before you sign an outsourcing contract, you need to make sure it has a reasonable termination provision.”

Because vetting companies properly can require extensive work, Ms. Deabler said, the work can be given to an experienced practice management consultant. “The consultant can start with a cost-benefit analysis that will show you whether outsourcing would be worthwhile,” she said.
 

Working with outsource service providers

Mr. Holder said that doctors should keep track of what the outsourcer is doing rather than simply let them do their work. “For example, doctors should understand the billing codes they use most often, such as the five levels of evaluation and management codes, and not just blindly rely on the billing company to code and bill their work correctly,” he noted.

Ms. Deabler said that companies provide monthly reports on their work. “Doctors should be reading these reports and contacting the company if expectations aren’t met,” she said.

Even in the reports, companies can hide problems from untrained eyes, Mr. Holder said. “For example, anyone can meet a metric like days in accounts receivable simply by writing off any charge that isn’t paid after 90 days.”

“You need to be engaged with the outsourcer,” he said. “It’s also a good idea to bring in a consultant to periodically check an outsourcer’s work.”
 

Will outsourcing expand in the future?

Mr. Holder said that the increasing use of value-based care may require practices to rely more on outsourcing in the future. “For instance, if a practice has a value-based contract that requires providing behavioral health services to patients, it might make sense to outsource that work rather than hire psychologists in-house,” he said.

Practices rarely outsource clinical services, but Mr. Holder said that this may happen in the future: “Now that Medicare is paying less for telehealth, practices have to find a way to provide it without using expensive examining room space,” he said. “Some practices may decide to outsource telehealth instead.”

Mr. Shay said that there are many reasons why outsourcing has a strong future. “It allows you to concentrate on your clinical care, and it is a solution to problems with turnover of in-house staff,” he said. “It can also be more efficient because the service is presumably an expert in areas like billing and collections, which means it may be able to ensure more efficient and faster reimbursements. And if the work is outsourced overseas, you can save money through lower worker salaries.”

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

Outsourcing certain staff functions in a practice to outside contractors working in remote locations has become commonplace in many medical practices.

Health care outsourcing services, also known as virtual assistants (VAs), were already booming in 2017, when volume grew by 36%. Then, the COVID-19 pandemic in 2020 normalized off-site work, which was a boon to outsourcing providers.

The most popular services being outsourced today by medical practices include billing, scribes, telephone calls to patients, and processing prior authorizations.

“Outsourcing is not for everyone, but I’ve seen it work for many practices,” said Lara Hochman, MD, a practice management consultant in Austin, Tex. She said that practices have used outsourcing to solve problems like high staff turnover, tight budgets, and inefficient use of staff.

When in-house staffing is insufficient or not appropriately aligned with the task, outsourcing can produce big savings, said Teri Deabler, a practice management consultant with the Texas Medical Association.

For example, she said that a client was paying an in-house accountant $80,000 a year. When the accountant retired, she was replaced with a part-time bookkeeper earning $20,000 while her accounting work was outsourced at a cost of $20,000 a year. “The practice’s costs for this service were cut in half,” Ms. Deabler said.
 

What functions lend themselves to outsourcing?

Clinical services are rarely outsourced by individual practices – although hospitals now outsource numerous clinical services – but virtually any kind of administrative service can be contracted out. Outsourcing used to be limited mainly to billing and off-hours phone services, but today, more services are available, such as scribing, processing prior authorizations, accounting and bookkeeping, human resources (HR) and payroll, interactions with social media, recredentialing, medical transcription, and marketing.

Meanwhile, the original outsourced services have evolved. Billing and collections may now be handled by off-shore VAs, and phone services now deal with a wider variety of tasks, such as answering patients’ questions, scheduling appointments, and making referrals.

Ron Holder, chief operating officer of Medical Group Management Association in Englewood, Colo., said that some outsourcing services can also adjust the amount of work provided based on the customer’s needs. “For instance, an IT outsourcer may allow you to scale up IT support for a new big tech project, such as installing a new electronic health record,” he said.

The outsourced service provider, who might work in another state or another country, is connected to the practice by phone and electronically, and represents the practice when dealing with patients, insurers, or other vendors.

“No one, including patients and your physicians, should know that they are dealing with an outsourced company,” said Mr. Holder. “The work, look, and feel of the outsourced functions should be seamless. Employees at the outsourcer should always identify themselves as the practice, not the outsourcing service.”

Dr. Hochman said that many outsourcing companies dedicate a particular worker to a particular practice and train them to work there. One example of this approach is Provider’s Choice Scribe Services, based in San Antonio. On its website, the company notes that each scribe is paired with a doctor and learns his or her documentation preferences, EMR use, and charting requirements.
 

What medical practices benefit most from outsourcing?

All kinds and sizes of practices contract with outsourcing firms, but the arrangement is particularly useful for smaller practices, Mr. Holder said. “Larger practices have the economies of scale that allow services to be in-house,” he said, “but smaller practices don’t have that opportunity.”

Dr. Hochman added that outsourcing firms can be hired part-time when the practice doesn’t have enough work for a full-time position. Alternatively, a full-time outsourcing firm can perform two or more separate tasks, such as scribing while handling prior authorizations, she said.

Outsourcing is also useful for new practices, Ms. Deabler said. “A new practice is not earning much money, so it has to have a bare-bones staff,” she said. “Billing, for example, should be contracted out, but it won’t cost that much, because the outsourcer typically charges by volume, and the volume in a new practice is low.”

Meanwhile, Mr. Holder said that the outsourcing of prior authorization work can particularly benefit specialty practices because they typically have a lot of prior authorizations to deal with.
 

The pros and cons of outsourcing

Experts with experience in outsourcing agree there are both pluses and minuses. “Practices with outsourced workers have less overhead, don’t have to deal with staff turnover, and costs may be lower than for in-house staff,” Ms. Deabler said. “However, you have limited control over outsourced workers and the practice may seem more anonymous to patients, so you need to consider this option very carefully.”

“With outsourcing, you lose control,” said John Machata, MD, a recently retired solo family physician in Wickford, R.I. “You’re trusting someone else to do work that you could do anyway.”

When he briefly considered outsourcing the practice’s billing many years ago, he found that billing companies wouldn’t handle bills that took a lot of work, such as getting in touch with the insurance company and explaining the patient’s situation. “They would only handle the easy bills, which the practice could do anyway,” he said.

However, he does think that answering services may be useful to outsource. “Patients are more inclined to call an anonymous entity than the doctor,” he said. When he gave patients his cell phone number, he said that some patients held off from calling because they didn’t want to bother him.

“Outsourced staff should be less expensive than in-house staff,” said Daniel Shay, an attorney at Gosfield & Associates in Philadelphia. “On the other hand, you are liable for the outsourcer’s mistakes. If your outsourced billing company is upcoding claims, your practice would be on the hook for repayment and penalties.”

Mr. Holder said: “An outsourcer ought to be more efficient at its chosen task because that is what they know how to do. This is a plus at a small practice, where the practice manager may need to do the billing, HR, IT, marketing, some legal work, and accounting,” he said. “No one person can do all of those things well.”

He added, however, “If you choose outsourcing and then decide you don’t like it, it’s difficult to unwind the arrangement. Staff that have been dismissed can’t easily be hired back, so it shouldn’t be an easy decision to make.”

Also, sometimes the staff at offshore outsourcing firms may have accents that are harder for patients to understand, and the offshore staff may not readily understand a U.S. caller. However, Dr. Hochman said that practices often have a chance to interview and select specific persons on the offshore team who best fit their needs.
 

Offshore outsourcing

Outsourcing firms have been moving abroad, where costs are lower. Typical venues are India and the Philippines because there are larger percentages of people who speak English. Since 2020, demand at offshore medical billing companies has been growing faster than their domestic counterparts, according to a recent analysis.

The difference in price can be substantial. In 2020, the average salary for scribes in India was $500 a month, compared with $2,500 for scribes in the United States.

However, offshore outsourcing is starting to face limitations in some places because of privacy issues, according to David J. Zetter, a practice management consultant in Mechanicsburg, Pa. He pointed to a new Florida law that limits use of offshore vendors because they deal with confidential patient information. The law, which became effective July 1, requires that any protected health information must be maintained in the United States or Canada.

“This will make it very hard for many types of offshore vendors to operate in Florida,” he said. He noted that Florida is the only state with such a restriction, but similar proposals are under consideration in a few other states, such as Texas.
 

How to select the right company

Mr. Zetter said that the biggest mistake practices make when choosing a company is failing to take enough time to examine their choice. “Quite often, practices don’t validate that companies know what they are doing,” he said. “They get a recommendation and go with it.”

“Choose a company with experience in your specialty,” Mr. Zetter advised. “Speak with the company’s clients, not just the ones the company gives you to speak to. You should ask for the full list of clients and speak to all of them.”

Ms. Deabler said that it’s fairly easy to find respected outsourcing companies. “Colleagues can make recommendations, state and specialty societies can provide lists of preferred vendors, and you can visit vendors’ booths at medical conferences,” she said. She added that it’s also easy to find evaluations of each company. “You can Google the company and come up with all kinds of information about it,” she said.

Mr. Shay said that practices should make sure they understand the terms of the contract with a VA. “Depending on how the contract is worded, you may be stuck with the relationship for many years,” he said. “Before you sign an outsourcing contract, you need to make sure it has a reasonable termination provision.”

Because vetting companies properly can require extensive work, Ms. Deabler said, the work can be given to an experienced practice management consultant. “The consultant can start with a cost-benefit analysis that will show you whether outsourcing would be worthwhile,” she said.
 

Working with outsource service providers

Mr. Holder said that doctors should keep track of what the outsourcer is doing rather than simply let them do their work. “For example, doctors should understand the billing codes they use most often, such as the five levels of evaluation and management codes, and not just blindly rely on the billing company to code and bill their work correctly,” he noted.

Ms. Deabler said that companies provide monthly reports on their work. “Doctors should be reading these reports and contacting the company if expectations aren’t met,” she said.

Even in the reports, companies can hide problems from untrained eyes, Mr. Holder said. “For example, anyone can meet a metric like days in accounts receivable simply by writing off any charge that isn’t paid after 90 days.”

“You need to be engaged with the outsourcer,” he said. “It’s also a good idea to bring in a consultant to periodically check an outsourcer’s work.”
 

Will outsourcing expand in the future?

Mr. Holder said that the increasing use of value-based care may require practices to rely more on outsourcing in the future. “For instance, if a practice has a value-based contract that requires providing behavioral health services to patients, it might make sense to outsource that work rather than hire psychologists in-house,” he said.

Practices rarely outsource clinical services, but Mr. Holder said that this may happen in the future: “Now that Medicare is paying less for telehealth, practices have to find a way to provide it without using expensive examining room space,” he said. “Some practices may decide to outsource telehealth instead.”

Mr. Shay said that there are many reasons why outsourcing has a strong future. “It allows you to concentrate on your clinical care, and it is a solution to problems with turnover of in-house staff,” he said. “It can also be more efficient because the service is presumably an expert in areas like billing and collections, which means it may be able to ensure more efficient and faster reimbursements. And if the work is outsourced overseas, you can save money through lower worker salaries.”

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

Outsourcing certain staff functions in a practice to outside contractors working in remote locations has become commonplace in many medical practices.

Health care outsourcing services, also known as virtual assistants (VAs), were already booming in 2017, when volume grew by 36%. Then, the COVID-19 pandemic in 2020 normalized off-site work, which was a boon to outsourcing providers.

The most popular services being outsourced today by medical practices include billing, scribes, telephone calls to patients, and processing prior authorizations.

“Outsourcing is not for everyone, but I’ve seen it work for many practices,” said Lara Hochman, MD, a practice management consultant in Austin, Tex. She said that practices have used outsourcing to solve problems like high staff turnover, tight budgets, and inefficient use of staff.

When in-house staffing is insufficient or not appropriately aligned with the task, outsourcing can produce big savings, said Teri Deabler, a practice management consultant with the Texas Medical Association.

For example, she said that a client was paying an in-house accountant $80,000 a year. When the accountant retired, she was replaced with a part-time bookkeeper earning $20,000 while her accounting work was outsourced at a cost of $20,000 a year. “The practice’s costs for this service were cut in half,” Ms. Deabler said.
 

What functions lend themselves to outsourcing?

Clinical services are rarely outsourced by individual practices – although hospitals now outsource numerous clinical services – but virtually any kind of administrative service can be contracted out. Outsourcing used to be limited mainly to billing and off-hours phone services, but today, more services are available, such as scribing, processing prior authorizations, accounting and bookkeeping, human resources (HR) and payroll, interactions with social media, recredentialing, medical transcription, and marketing.

Meanwhile, the original outsourced services have evolved. Billing and collections may now be handled by off-shore VAs, and phone services now deal with a wider variety of tasks, such as answering patients’ questions, scheduling appointments, and making referrals.

Ron Holder, chief operating officer of Medical Group Management Association in Englewood, Colo., said that some outsourcing services can also adjust the amount of work provided based on the customer’s needs. “For instance, an IT outsourcer may allow you to scale up IT support for a new big tech project, such as installing a new electronic health record,” he said.

The outsourced service provider, who might work in another state or another country, is connected to the practice by phone and electronically, and represents the practice when dealing with patients, insurers, or other vendors.

“No one, including patients and your physicians, should know that they are dealing with an outsourced company,” said Mr. Holder. “The work, look, and feel of the outsourced functions should be seamless. Employees at the outsourcer should always identify themselves as the practice, not the outsourcing service.”

Dr. Hochman said that many outsourcing companies dedicate a particular worker to a particular practice and train them to work there. One example of this approach is Provider’s Choice Scribe Services, based in San Antonio. On its website, the company notes that each scribe is paired with a doctor and learns his or her documentation preferences, EMR use, and charting requirements.
 

What medical practices benefit most from outsourcing?

All kinds and sizes of practices contract with outsourcing firms, but the arrangement is particularly useful for smaller practices, Mr. Holder said. “Larger practices have the economies of scale that allow services to be in-house,” he said, “but smaller practices don’t have that opportunity.”

Dr. Hochman added that outsourcing firms can be hired part-time when the practice doesn’t have enough work for a full-time position. Alternatively, a full-time outsourcing firm can perform two or more separate tasks, such as scribing while handling prior authorizations, she said.

Outsourcing is also useful for new practices, Ms. Deabler said. “A new practice is not earning much money, so it has to have a bare-bones staff,” she said. “Billing, for example, should be contracted out, but it won’t cost that much, because the outsourcer typically charges by volume, and the volume in a new practice is low.”

Meanwhile, Mr. Holder said that the outsourcing of prior authorization work can particularly benefit specialty practices because they typically have a lot of prior authorizations to deal with.
 

The pros and cons of outsourcing

Experts with experience in outsourcing agree there are both pluses and minuses. “Practices with outsourced workers have less overhead, don’t have to deal with staff turnover, and costs may be lower than for in-house staff,” Ms. Deabler said. “However, you have limited control over outsourced workers and the practice may seem more anonymous to patients, so you need to consider this option very carefully.”

“With outsourcing, you lose control,” said John Machata, MD, a recently retired solo family physician in Wickford, R.I. “You’re trusting someone else to do work that you could do anyway.”

When he briefly considered outsourcing the practice’s billing many years ago, he found that billing companies wouldn’t handle bills that took a lot of work, such as getting in touch with the insurance company and explaining the patient’s situation. “They would only handle the easy bills, which the practice could do anyway,” he said.

However, he does think that answering services may be useful to outsource. “Patients are more inclined to call an anonymous entity than the doctor,” he said. When he gave patients his cell phone number, he said that some patients held off from calling because they didn’t want to bother him.

“Outsourced staff should be less expensive than in-house staff,” said Daniel Shay, an attorney at Gosfield & Associates in Philadelphia. “On the other hand, you are liable for the outsourcer’s mistakes. If your outsourced billing company is upcoding claims, your practice would be on the hook for repayment and penalties.”

Mr. Holder said: “An outsourcer ought to be more efficient at its chosen task because that is what they know how to do. This is a plus at a small practice, where the practice manager may need to do the billing, HR, IT, marketing, some legal work, and accounting,” he said. “No one person can do all of those things well.”

He added, however, “If you choose outsourcing and then decide you don’t like it, it’s difficult to unwind the arrangement. Staff that have been dismissed can’t easily be hired back, so it shouldn’t be an easy decision to make.”

Also, sometimes the staff at offshore outsourcing firms may have accents that are harder for patients to understand, and the offshore staff may not readily understand a U.S. caller. However, Dr. Hochman said that practices often have a chance to interview and select specific persons on the offshore team who best fit their needs.
 

Offshore outsourcing

Outsourcing firms have been moving abroad, where costs are lower. Typical venues are India and the Philippines because there are larger percentages of people who speak English. Since 2020, demand at offshore medical billing companies has been growing faster than their domestic counterparts, according to a recent analysis.

The difference in price can be substantial. In 2020, the average salary for scribes in India was $500 a month, compared with $2,500 for scribes in the United States.

However, offshore outsourcing is starting to face limitations in some places because of privacy issues, according to David J. Zetter, a practice management consultant in Mechanicsburg, Pa. He pointed to a new Florida law that limits use of offshore vendors because they deal with confidential patient information. The law, which became effective July 1, requires that any protected health information must be maintained in the United States or Canada.

“This will make it very hard for many types of offshore vendors to operate in Florida,” he said. He noted that Florida is the only state with such a restriction, but similar proposals are under consideration in a few other states, such as Texas.
 

How to select the right company

Mr. Zetter said that the biggest mistake practices make when choosing a company is failing to take enough time to examine their choice. “Quite often, practices don’t validate that companies know what they are doing,” he said. “They get a recommendation and go with it.”

“Choose a company with experience in your specialty,” Mr. Zetter advised. “Speak with the company’s clients, not just the ones the company gives you to speak to. You should ask for the full list of clients and speak to all of them.”

Ms. Deabler said that it’s fairly easy to find respected outsourcing companies. “Colleagues can make recommendations, state and specialty societies can provide lists of preferred vendors, and you can visit vendors’ booths at medical conferences,” she said. She added that it’s also easy to find evaluations of each company. “You can Google the company and come up with all kinds of information about it,” she said.

Mr. Shay said that practices should make sure they understand the terms of the contract with a VA. “Depending on how the contract is worded, you may be stuck with the relationship for many years,” he said. “Before you sign an outsourcing contract, you need to make sure it has a reasonable termination provision.”

Because vetting companies properly can require extensive work, Ms. Deabler said, the work can be given to an experienced practice management consultant. “The consultant can start with a cost-benefit analysis that will show you whether outsourcing would be worthwhile,” she said.
 

Working with outsource service providers

Mr. Holder said that doctors should keep track of what the outsourcer is doing rather than simply let them do their work. “For example, doctors should understand the billing codes they use most often, such as the five levels of evaluation and management codes, and not just blindly rely on the billing company to code and bill their work correctly,” he noted.

Ms. Deabler said that companies provide monthly reports on their work. “Doctors should be reading these reports and contacting the company if expectations aren’t met,” she said.

Even in the reports, companies can hide problems from untrained eyes, Mr. Holder said. “For example, anyone can meet a metric like days in accounts receivable simply by writing off any charge that isn’t paid after 90 days.”

“You need to be engaged with the outsourcer,” he said. “It’s also a good idea to bring in a consultant to periodically check an outsourcer’s work.”
 

Will outsourcing expand in the future?

Mr. Holder said that the increasing use of value-based care may require practices to rely more on outsourcing in the future. “For instance, if a practice has a value-based contract that requires providing behavioral health services to patients, it might make sense to outsource that work rather than hire psychologists in-house,” he said.

Practices rarely outsource clinical services, but Mr. Holder said that this may happen in the future: “Now that Medicare is paying less for telehealth, practices have to find a way to provide it without using expensive examining room space,” he said. “Some practices may decide to outsource telehealth instead.”

Mr. Shay said that there are many reasons why outsourcing has a strong future. “It allows you to concentrate on your clinical care, and it is a solution to problems with turnover of in-house staff,” he said. “It can also be more efficient because the service is presumably an expert in areas like billing and collections, which means it may be able to ensure more efficient and faster reimbursements. And if the work is outsourced overseas, you can save money through lower worker salaries.”

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