Clinician Reviews

Some physicians are frustrated that key information about implantable medical devices rarely makes it into electronic health records, despite a 10-year mandate on manufacturers to label these products with identifiers.

As a result of this siloing of information, patients are not getting the expected benefits of a regulation finalized over a decade ago by the U.S. Food and Drug Administration.

In 2013, the agency ordered companies to include unique device identifiers (UDIs) in plain-text and barcode format on some device labels, starting with implanted devices that are considered life-sustaining. The FDA said that tracking of UDI information would speed detection of complications linked to devices.

But identifiers are rarely on devices. At the time of the regulation creation, the FDA also said it expected this data would be integrated into EHRs. But only a few pioneer organizations such as Duke University and Mercy Health have so far attempted to track any UDI data in an organized way, researchers say.

Richard J. Kovacs, MD, the chief medical officer of the American College of Cardiology, contrasted the lack of useful implementation of UDI data with the speedy transfers of information that happen routinely in other industries. For example, employees of car rental agencies use handheld devices to gather detailed information about the vehicles being returned.

“But if you go to an emergency room with a medical device in your body, no one knows what it is or where it came from or anything about it,” Dr. Kovacs said in an interview.

Many physicians with expertise in device research have pushed for years to have insurers like Medicare require identification information on medical claims.

Even researchers face multiple obstacles in trying to investigate how well UDIs have been incorporated into EHRs and outcomes tied to certain devices.

In August, a Harvard team published a study in JAMA Internal Medicine, attempting to analyze the risks of endovascular aortic repair (EVAR) devices. They reported an 11.6% risk for serious blood leaks with AFX Endovascular AAA System aneurysm devices, more than double the 5.7% risk estimated for competing products. The team selected EVAR devices for the study due in part to their known safety concerns. Endologix, the maker of the devices, declined to comment for this story.

The Harvard team used data from the Veterans Affairs health system, which is considered more well organized than most other health systems. But UDI information was found for only 19 of the 13,941 patients whose records were studied. In those cases, only partial information was included.

The researchers developed natural language processing tools, which they used to scrounge clinical notes for information about which devices patients received.

Using this method isn’t feasible for most clinicians, given that records from independent hospitals might not provide this kind of data and descriptions to search, according to the authors of an editorial accompanying the paper. Those researchers urged Congress to pass a law mandating inclusion of UDIs for all devices on claims forms as a condition for reimbursement by federal health care programs.

Setback for advocates

The movement toward UDI suffered a setback in June.

An influential, but little known federal advisory panel, the National Committee on Vital Health Statistics (NCVHS), opted to not recommend use of this information in claims, saying the FDA should consider the matter further.

Gaining an NCVHS recommendation would have been a win, said Sen. Elizabeth Warren (D-MA), Sen. Charles E. Grassley (R-IA), and Rep. Bill Pascrell Jr. (D-NJ), in a December 2022 letter to the panel.

Including UDI data would let researchers track patients’ interactions with a health system and could be used to establish population-level correlations between a particular device and a long-term outcome or side effect, the lawmakers said.

That view had the support of at least one major maker of devices, Cook Group, which sells products for a variety of specialties, including cardiology.

In a comment to NCVHS, Cook urged for the inclusion identifiers in Medicare claims.

“While some have argued that the UDI is better suited for inclusion in the electronic health records, Cook believes this argument sets up a false choice between the two,” wrote Stephen L. Ferguson, JD, the chairman of Cook’s board. “Inclusion of the UDI in both electronic health records and claims forms will lead to a more robust system of real-world data.”

In contrast, AdvaMed, the trade group for device makers, told the NCVHS that it did not support adding the information to payment claims submissions, instead just supporting the inclusion in EHRs.

Dr. Kovacs of the ACC said one potential drawback to more transparency could be challenges in interpreting reports of complications in certain cases, at least initially. Reports about a flaw or even a suspected flaw in a device might lead patients to become concerned about their implanted devices, potentially registering unfounded complaints.

But this concern can be addressed through using “scientific rigor and safeguards” and is outweighed by the potential safety benefits for patients, Dr. Kovacs said.

Patients should ask health care systems to track and share information about their implanted devices, Dr. Kovacs suggested.

“I feel it would be my right to demand that that device information follows my electronic medical record, so that it’s readily available to anyone who’s taking care of me,” Dr. Kovacs said. “They would know what it is that’s in me, whether it’s a lens in my eye or a prosthesis in my hip or a highly complicated implantable cardiac electronic device.”

The Harvard study was supported by the FDA and National Institutes of Health. Authors of the study reported receiving fees from the FDA, Burroughs Wellcome Fund, and Harvard-MIT Center for Regulatory Science outside the submitted work. No other disclosures were reported. Authors of the editorial reported past and present connections with F-Prime Capital, FDA, Johnson & Johnson, the Medical Devices Innovation Consortium; the Agency for Healthcare Research and Quality; the National Heart, Lung, and Blood Institute; and Arnold Ventures, as well being an expert witness at in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against Biogen. Authors of the Viewpoint reported past and present connections with the National Evaluation System for Health Technology Coordinating Center (NESTcc), which is part of the Medical Device Innovation Consortium (MDIC); AIM North America UDI Advisory Committee, Mass General Brigham, Arnold Ventures; the Institute for Clinical and Economic Review California Technology Assessment Forum; Yale University, Johnson & Johnson, FD, Agency for Healthcare Research and Quality; the National Heart, Lung, and Blood Institute of the National Institutes of Health; as well as having been an expert witness in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against.

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

Some physicians are frustrated that key information about implantable medical devices rarely makes it into electronic health records, despite a 10-year mandate on manufacturers to label these products with identifiers.

As a result of this siloing of information, patients are not getting the expected benefits of a regulation finalized over a decade ago by the U.S. Food and Drug Administration.

In 2013, the agency ordered companies to include unique device identifiers (UDIs) in plain-text and barcode format on some device labels, starting with implanted devices that are considered life-sustaining. The FDA said that tracking of UDI information would speed detection of complications linked to devices.

But identifiers are rarely on devices. At the time of the regulation creation, the FDA also said it expected this data would be integrated into EHRs. But only a few pioneer organizations such as Duke University and Mercy Health have so far attempted to track any UDI data in an organized way, researchers say.

Richard J. Kovacs, MD, the chief medical officer of the American College of Cardiology, contrasted the lack of useful implementation of UDI data with the speedy transfers of information that happen routinely in other industries. For example, employees of car rental agencies use handheld devices to gather detailed information about the vehicles being returned.

“But if you go to an emergency room with a medical device in your body, no one knows what it is or where it came from or anything about it,” Dr. Kovacs said in an interview.

Many physicians with expertise in device research have pushed for years to have insurers like Medicare require identification information on medical claims.

Even researchers face multiple obstacles in trying to investigate how well UDIs have been incorporated into EHRs and outcomes tied to certain devices.

In August, a Harvard team published a study in JAMA Internal Medicine, attempting to analyze the risks of endovascular aortic repair (EVAR) devices. They reported an 11.6% risk for serious blood leaks with AFX Endovascular AAA System aneurysm devices, more than double the 5.7% risk estimated for competing products. The team selected EVAR devices for the study due in part to their known safety concerns. Endologix, the maker of the devices, declined to comment for this story.

The Harvard team used data from the Veterans Affairs health system, which is considered more well organized than most other health systems. But UDI information was found for only 19 of the 13,941 patients whose records were studied. In those cases, only partial information was included.

The researchers developed natural language processing tools, which they used to scrounge clinical notes for information about which devices patients received.

Using this method isn’t feasible for most clinicians, given that records from independent hospitals might not provide this kind of data and descriptions to search, according to the authors of an editorial accompanying the paper. Those researchers urged Congress to pass a law mandating inclusion of UDIs for all devices on claims forms as a condition for reimbursement by federal health care programs.

Setback for advocates

The movement toward UDI suffered a setback in June.

An influential, but little known federal advisory panel, the National Committee on Vital Health Statistics (NCVHS), opted to not recommend use of this information in claims, saying the FDA should consider the matter further.

Gaining an NCVHS recommendation would have been a win, said Sen. Elizabeth Warren (D-MA), Sen. Charles E. Grassley (R-IA), and Rep. Bill Pascrell Jr. (D-NJ), in a December 2022 letter to the panel.

Including UDI data would let researchers track patients’ interactions with a health system and could be used to establish population-level correlations between a particular device and a long-term outcome or side effect, the lawmakers said.

That view had the support of at least one major maker of devices, Cook Group, which sells products for a variety of specialties, including cardiology.

In a comment to NCVHS, Cook urged for the inclusion identifiers in Medicare claims.

“While some have argued that the UDI is better suited for inclusion in the electronic health records, Cook believes this argument sets up a false choice between the two,” wrote Stephen L. Ferguson, JD, the chairman of Cook’s board. “Inclusion of the UDI in both electronic health records and claims forms will lead to a more robust system of real-world data.”

In contrast, AdvaMed, the trade group for device makers, told the NCVHS that it did not support adding the information to payment claims submissions, instead just supporting the inclusion in EHRs.

Dr. Kovacs of the ACC said one potential drawback to more transparency could be challenges in interpreting reports of complications in certain cases, at least initially. Reports about a flaw or even a suspected flaw in a device might lead patients to become concerned about their implanted devices, potentially registering unfounded complaints.

But this concern can be addressed through using “scientific rigor and safeguards” and is outweighed by the potential safety benefits for patients, Dr. Kovacs said.

Patients should ask health care systems to track and share information about their implanted devices, Dr. Kovacs suggested.

“I feel it would be my right to demand that that device information follows my electronic medical record, so that it’s readily available to anyone who’s taking care of me,” Dr. Kovacs said. “They would know what it is that’s in me, whether it’s a lens in my eye or a prosthesis in my hip or a highly complicated implantable cardiac electronic device.”

The Harvard study was supported by the FDA and National Institutes of Health. Authors of the study reported receiving fees from the FDA, Burroughs Wellcome Fund, and Harvard-MIT Center for Regulatory Science outside the submitted work. No other disclosures were reported. Authors of the editorial reported past and present connections with F-Prime Capital, FDA, Johnson & Johnson, the Medical Devices Innovation Consortium; the Agency for Healthcare Research and Quality; the National Heart, Lung, and Blood Institute; and Arnold Ventures, as well being an expert witness at in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against Biogen. Authors of the Viewpoint reported past and present connections with the National Evaluation System for Health Technology Coordinating Center (NESTcc), which is part of the Medical Device Innovation Consortium (MDIC); AIM North America UDI Advisory Committee, Mass General Brigham, Arnold Ventures; the Institute for Clinical and Economic Review California Technology Assessment Forum; Yale University, Johnson & Johnson, FD, Agency for Healthcare Research and Quality; the National Heart, Lung, and Blood Institute of the National Institutes of Health; as well as having been an expert witness in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against.

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

Some physicians are frustrated that key information about implantable medical devices rarely makes it into electronic health records, despite a 10-year mandate on manufacturers to label these products with identifiers.

As a result of this siloing of information, patients are not getting the expected benefits of a regulation finalized over a decade ago by the U.S. Food and Drug Administration.

In 2013, the agency ordered companies to include unique device identifiers (UDIs) in plain-text and barcode format on some device labels, starting with implanted devices that are considered life-sustaining. The FDA said that tracking of UDI information would speed detection of complications linked to devices.

But identifiers are rarely on devices. At the time of the regulation creation, the FDA also said it expected this data would be integrated into EHRs. But only a few pioneer organizations such as Duke University and Mercy Health have so far attempted to track any UDI data in an organized way, researchers say.

Richard J. Kovacs, MD, the chief medical officer of the American College of Cardiology, contrasted the lack of useful implementation of UDI data with the speedy transfers of information that happen routinely in other industries. For example, employees of car rental agencies use handheld devices to gather detailed information about the vehicles being returned.

“But if you go to an emergency room with a medical device in your body, no one knows what it is or where it came from or anything about it,” Dr. Kovacs said in an interview.

Many physicians with expertise in device research have pushed for years to have insurers like Medicare require identification information on medical claims.

Even researchers face multiple obstacles in trying to investigate how well UDIs have been incorporated into EHRs and outcomes tied to certain devices.

In August, a Harvard team published a study in JAMA Internal Medicine, attempting to analyze the risks of endovascular aortic repair (EVAR) devices. They reported an 11.6% risk for serious blood leaks with AFX Endovascular AAA System aneurysm devices, more than double the 5.7% risk estimated for competing products. The team selected EVAR devices for the study due in part to their known safety concerns. Endologix, the maker of the devices, declined to comment for this story.

The Harvard team used data from the Veterans Affairs health system, which is considered more well organized than most other health systems. But UDI information was found for only 19 of the 13,941 patients whose records were studied. In those cases, only partial information was included.

The researchers developed natural language processing tools, which they used to scrounge clinical notes for information about which devices patients received.

Using this method isn’t feasible for most clinicians, given that records from independent hospitals might not provide this kind of data and descriptions to search, according to the authors of an editorial accompanying the paper. Those researchers urged Congress to pass a law mandating inclusion of UDIs for all devices on claims forms as a condition for reimbursement by federal health care programs.

Setback for advocates

The movement toward UDI suffered a setback in June.

An influential, but little known federal advisory panel, the National Committee on Vital Health Statistics (NCVHS), opted to not recommend use of this information in claims, saying the FDA should consider the matter further.

Gaining an NCVHS recommendation would have been a win, said Sen. Elizabeth Warren (D-MA), Sen. Charles E. Grassley (R-IA), and Rep. Bill Pascrell Jr. (D-NJ), in a December 2022 letter to the panel.

Including UDI data would let researchers track patients’ interactions with a health system and could be used to establish population-level correlations between a particular device and a long-term outcome or side effect, the lawmakers said.

That view had the support of at least one major maker of devices, Cook Group, which sells products for a variety of specialties, including cardiology.

In a comment to NCVHS, Cook urged for the inclusion identifiers in Medicare claims.

“While some have argued that the UDI is better suited for inclusion in the electronic health records, Cook believes this argument sets up a false choice between the two,” wrote Stephen L. Ferguson, JD, the chairman of Cook’s board. “Inclusion of the UDI in both electronic health records and claims forms will lead to a more robust system of real-world data.”

In contrast, AdvaMed, the trade group for device makers, told the NCVHS that it did not support adding the information to payment claims submissions, instead just supporting the inclusion in EHRs.

Dr. Kovacs of the ACC said one potential drawback to more transparency could be challenges in interpreting reports of complications in certain cases, at least initially. Reports about a flaw or even a suspected flaw in a device might lead patients to become concerned about their implanted devices, potentially registering unfounded complaints.

But this concern can be addressed through using “scientific rigor and safeguards” and is outweighed by the potential safety benefits for patients, Dr. Kovacs said.

Patients should ask health care systems to track and share information about their implanted devices, Dr. Kovacs suggested.

“I feel it would be my right to demand that that device information follows my electronic medical record, so that it’s readily available to anyone who’s taking care of me,” Dr. Kovacs said. “They would know what it is that’s in me, whether it’s a lens in my eye or a prosthesis in my hip or a highly complicated implantable cardiac electronic device.”

The Harvard study was supported by the FDA and National Institutes of Health. Authors of the study reported receiving fees from the FDA, Burroughs Wellcome Fund, and Harvard-MIT Center for Regulatory Science outside the submitted work. No other disclosures were reported. Authors of the editorial reported past and present connections with F-Prime Capital, FDA, Johnson & Johnson, the Medical Devices Innovation Consortium; the Agency for Healthcare Research and Quality; the National Heart, Lung, and Blood Institute; and Arnold Ventures, as well being an expert witness at in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against Biogen. Authors of the Viewpoint reported past and present connections with the National Evaluation System for Health Technology Coordinating Center (NESTcc), which is part of the Medical Device Innovation Consortium (MDIC); AIM North America UDI Advisory Committee, Mass General Brigham, Arnold Ventures; the Institute for Clinical and Economic Review California Technology Assessment Forum; Yale University, Johnson & Johnson, FD, Agency for Healthcare Research and Quality; the National Heart, Lung, and Blood Institute of the National Institutes of Health; as well as having been an expert witness in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against.

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

A Miami-area nurse practitioner has been convicted of defrauding Medicare by submitting fraudulent claims for more than $200 million worth of unnecessary genetic testing and medical equipment, federal prosecutors announced.

Elizabeth Hernandez, 45, of Homestead, Fla., could face as many as 75 years in prison when she’s sentenced on December 14.

Ms. Hernandez overbilled Medicare by more than $200 million, according to prosecutors who say she ordered more cancer genetic tests for Medicare beneficiaries in 2020 than any other clinician in the nation. She “personally pocketed approximately $1.6 million in the scheme, which she used to purchase expensive cars, jewelry, home renovations, and travel,” prosecutors said.

After a 6-day trial, Ms. Hernandez was convicted last week of a single count of conspiracy to commit health care fraud and wire fraud, four counts of health care fraud and three counts of making false statements relating to health care matters. She was acquitted of two counts of health care fraud.

The case is part of an ongoing effort by federal prosecutors to target schemes alleged to have defrauded Medicare of billions of dollars in reimbursement for genetic testing and other health services.

Prosecutors alleged that Ms. Hernandez took advantage of the flexible telemedicine rules allowed during the COVID-19 pandemic, and she and another nurse “essentially robo-signed” the orders.

As part of the scheme, telemarketing companies would contact Medicare beneficiaries to convince them to request orthotic braces and genetic tests, and then send prefilled orders for these products to Ms. Hernandez, who signed them, attesting that she had examined or treated the patients, prosecutors said in a statement.

According to prosecutors, Ms. Hernandez billed Medicare as if she had performed complex in-person evaluations of patients. The time she attested she spent on these supposed office visits often accounted for more than 24 hours in a day. Prosecutors said Ms. Hernandez never examined the patients for whom she ordered $14 million in medical equipment, and that she lied when she certified that she’d personally examined them and determined the supplies were necessary.

Prosecutors also alleged that Ms. Hernandez ordered $119 million worth of unnecessary genetic tests for patients she wasn’t treating. The tests include “cancer genetic” (CGx) tests, which look for mutations that may raise the risk of certain diseases, and pharmacogenetic (PGx) tests, which can provide information about how patients will respond to medications.

According to prosecutors, Medicare only rarely covers CGx tests, doing so primarily when a patient has cancer and the patient’s physician orders such tests to improve treatment.

Ms. Hernandez also allegedly submitted claims for $1.3 million worth of telemedicine consultations that were not performed.

Prosecutors later put the total amount of fraudulent claims at more than $200 million.

Federal prosecutors also alleged that several companies that claimed to be in the telemedicine business gave bribes and kickbacks to Ms. Hernandez.

In recent years, federal officials have increasingly targeted schemes to defraud Medicare through fake claims for genetic testing. In 2020, for instance, prosecutors charged 345 defendants, including more than 100 doctors, nurses, and other licensed medical professionals, with submitting more than $6 billion in fraudulent claims for genetic testing and other services.

Last December, a Georgia man was convicted in a scheme alleged to have cost Medicare $463 million. He was accused of having “conspired with patient brokers, telemedicine companies, and call centers to target Medicare beneficiaries with telemarketing calls falsely stating that Medicare covered expensive cancer genetic tests,” according to a statement from federal prosecutors.

In a 2021 report, the inspector general of the U.S. Department of Health & Human Services warned that a sharp rise in Medicare payments for genetic tests could be a sign of fraud even as federal guidance related to coverage for genetic testing has been inconsistent. The payments quadrupled to $1.41 billion from 2016 to 2019.

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

A Miami-area nurse practitioner has been convicted of defrauding Medicare by submitting fraudulent claims for more than $200 million worth of unnecessary genetic testing and medical equipment, federal prosecutors announced.

Elizabeth Hernandez, 45, of Homestead, Fla., could face as many as 75 years in prison when she’s sentenced on December 14.

Ms. Hernandez overbilled Medicare by more than $200 million, according to prosecutors who say she ordered more cancer genetic tests for Medicare beneficiaries in 2020 than any other clinician in the nation. She “personally pocketed approximately $1.6 million in the scheme, which she used to purchase expensive cars, jewelry, home renovations, and travel,” prosecutors said.

After a 6-day trial, Ms. Hernandez was convicted last week of a single count of conspiracy to commit health care fraud and wire fraud, four counts of health care fraud and three counts of making false statements relating to health care matters. She was acquitted of two counts of health care fraud.

The case is part of an ongoing effort by federal prosecutors to target schemes alleged to have defrauded Medicare of billions of dollars in reimbursement for genetic testing and other health services.

Prosecutors alleged that Ms. Hernandez took advantage of the flexible telemedicine rules allowed during the COVID-19 pandemic, and she and another nurse “essentially robo-signed” the orders.

As part of the scheme, telemarketing companies would contact Medicare beneficiaries to convince them to request orthotic braces and genetic tests, and then send prefilled orders for these products to Ms. Hernandez, who signed them, attesting that she had examined or treated the patients, prosecutors said in a statement.

According to prosecutors, Ms. Hernandez billed Medicare as if she had performed complex in-person evaluations of patients. The time she attested she spent on these supposed office visits often accounted for more than 24 hours in a day. Prosecutors said Ms. Hernandez never examined the patients for whom she ordered $14 million in medical equipment, and that she lied when she certified that she’d personally examined them and determined the supplies were necessary.

Prosecutors also alleged that Ms. Hernandez ordered $119 million worth of unnecessary genetic tests for patients she wasn’t treating. The tests include “cancer genetic” (CGx) tests, which look for mutations that may raise the risk of certain diseases, and pharmacogenetic (PGx) tests, which can provide information about how patients will respond to medications.

According to prosecutors, Medicare only rarely covers CGx tests, doing so primarily when a patient has cancer and the patient’s physician orders such tests to improve treatment.

Ms. Hernandez also allegedly submitted claims for $1.3 million worth of telemedicine consultations that were not performed.

Prosecutors later put the total amount of fraudulent claims at more than $200 million.

Federal prosecutors also alleged that several companies that claimed to be in the telemedicine business gave bribes and kickbacks to Ms. Hernandez.

In recent years, federal officials have increasingly targeted schemes to defraud Medicare through fake claims for genetic testing. In 2020, for instance, prosecutors charged 345 defendants, including more than 100 doctors, nurses, and other licensed medical professionals, with submitting more than $6 billion in fraudulent claims for genetic testing and other services.

Last December, a Georgia man was convicted in a scheme alleged to have cost Medicare $463 million. He was accused of having “conspired with patient brokers, telemedicine companies, and call centers to target Medicare beneficiaries with telemarketing calls falsely stating that Medicare covered expensive cancer genetic tests,” according to a statement from federal prosecutors.

In a 2021 report, the inspector general of the U.S. Department of Health & Human Services warned that a sharp rise in Medicare payments for genetic tests could be a sign of fraud even as federal guidance related to coverage for genetic testing has been inconsistent. The payments quadrupled to $1.41 billion from 2016 to 2019.

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

A Miami-area nurse practitioner has been convicted of defrauding Medicare by submitting fraudulent claims for more than $200 million worth of unnecessary genetic testing and medical equipment, federal prosecutors announced.

Elizabeth Hernandez, 45, of Homestead, Fla., could face as many as 75 years in prison when she’s sentenced on December 14.

Ms. Hernandez overbilled Medicare by more than $200 million, according to prosecutors who say she ordered more cancer genetic tests for Medicare beneficiaries in 2020 than any other clinician in the nation. She “personally pocketed approximately $1.6 million in the scheme, which she used to purchase expensive cars, jewelry, home renovations, and travel,” prosecutors said.

After a 6-day trial, Ms. Hernandez was convicted last week of a single count of conspiracy to commit health care fraud and wire fraud, four counts of health care fraud and three counts of making false statements relating to health care matters. She was acquitted of two counts of health care fraud.

The case is part of an ongoing effort by federal prosecutors to target schemes alleged to have defrauded Medicare of billions of dollars in reimbursement for genetic testing and other health services.

Prosecutors alleged that Ms. Hernandez took advantage of the flexible telemedicine rules allowed during the COVID-19 pandemic, and she and another nurse “essentially robo-signed” the orders.

As part of the scheme, telemarketing companies would contact Medicare beneficiaries to convince them to request orthotic braces and genetic tests, and then send prefilled orders for these products to Ms. Hernandez, who signed them, attesting that she had examined or treated the patients, prosecutors said in a statement.

According to prosecutors, Ms. Hernandez billed Medicare as if she had performed complex in-person evaluations of patients. The time she attested she spent on these supposed office visits often accounted for more than 24 hours in a day. Prosecutors said Ms. Hernandez never examined the patients for whom she ordered $14 million in medical equipment, and that she lied when she certified that she’d personally examined them and determined the supplies were necessary.

Prosecutors also alleged that Ms. Hernandez ordered $119 million worth of unnecessary genetic tests for patients she wasn’t treating. The tests include “cancer genetic” (CGx) tests, which look for mutations that may raise the risk of certain diseases, and pharmacogenetic (PGx) tests, which can provide information about how patients will respond to medications.

According to prosecutors, Medicare only rarely covers CGx tests, doing so primarily when a patient has cancer and the patient’s physician orders such tests to improve treatment.

Ms. Hernandez also allegedly submitted claims for $1.3 million worth of telemedicine consultations that were not performed.

Prosecutors later put the total amount of fraudulent claims at more than $200 million.

Federal prosecutors also alleged that several companies that claimed to be in the telemedicine business gave bribes and kickbacks to Ms. Hernandez.

In recent years, federal officials have increasingly targeted schemes to defraud Medicare through fake claims for genetic testing. In 2020, for instance, prosecutors charged 345 defendants, including more than 100 doctors, nurses, and other licensed medical professionals, with submitting more than $6 billion in fraudulent claims for genetic testing and other services.

Last December, a Georgia man was convicted in a scheme alleged to have cost Medicare $463 million. He was accused of having “conspired with patient brokers, telemedicine companies, and call centers to target Medicare beneficiaries with telemarketing calls falsely stating that Medicare covered expensive cancer genetic tests,” according to a statement from federal prosecutors.

In a 2021 report, the inspector general of the U.S. Department of Health & Human Services warned that a sharp rise in Medicare payments for genetic tests could be a sign of fraud even as federal guidance related to coverage for genetic testing has been inconsistent. The payments quadrupled to $1.41 billion from 2016 to 2019.

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

Nearly 70% of adolescents and young adults stop taking oral 5-aminosalicylic acid (5-ASA) maintenance therapy within 12 months of ulcerative colitis (UC) diagnosis, new research from the United Kingdom indicates.

“This is concerning as they are at risk of their condition returning and further complications. It can also lead to severe complications such as surgery to remove part of the gut,” Sonia Saxena, MBBS, director, Imperial Child Health Unit, School of Public Health, Imperial College London, said in a news release.

The study “highlights the importance of counseling and education of patients at diagnosis as this is a critical window that influences long-term health behavior,” Ashwin Ananthakrishnan, MD, MPH, a gastroenterologist with Massachusetts General Hospital and Harvard Medical School, both in Boston, said in an interview.

“It has not been my experience in U.S.-based practice that the rates of discontinuation are that high, but it would be important to examine this in different locations,” added Dr. Ananthakrishnan, who wasn’t involved with the study.

The study was published online in the British Journal of General Practice.
 

Cases on the rise

Globally, the incidence of UC is increasing fastest in younger populations. It’s estimated that up to 30% of individuals with UC are diagnosed in childhood or young adulthood, and these individuals are more likely to have a severe disease course and years living with disability, compared with peers diagnosed later in life. This makes achieving disease control and maintaining remission “paramount” for those diagnosed in early life, Dr. Saxena and colleagues write.

International UC guidelines recommend starting therapy with 5-ASA, also known as mesalamine, soon after diagnosis and continuing it long term to maintain remission. However, some prior evidence suggests that adherence to UC medication may be less optimal in younger people – findings supported by the U.K. study.

Leveraging data from the UK Clinical Practice Research Datalink, Dr. Saxena and colleagues analyzed data for 607 children and young adults aged 10-24 years starting oral 5-ASA maintenance therapy for UC.

They found that 152 individuals (25%) stopped 5-ASA treatment after 1 month, and 419 (69%) discontinued it within 1 year of starting treatment. The median time to stopping the anti-inflammatory drug was 162 days.

Discontinuation rates were highest in young adults aged 18-24 years (74%). The transition to adult care and loss of support from caregivers who encourage adherence in adolescents and provide financial and practical support could be one explanation for this, the researchers write.

After accounting for other factors, young adults aged 18-24 years starting 5-ASA were 43% more likely to discontinue it in the first year than adolescents aged 10-14 years.

Individuals living in socioeconomically deprived areas were 46% more likely to stop treatment, compared with those living in more affluent areas, a finding that suggests the need to address socioeconomic disparities that could drive discontinuation, the authors say.

They also found that early corticosteroid use for an acute UC flare was associated with a 32% lower likelihood of stopping 5-ASA therapy.
 

Adherence falls short

In terms of adherence, defined as the proportion of days covered by 5-ASA medication, the mean was 72%, equivalent to just under 9 months. Adherence fell with older age at initiation of therapy. Adherence was 80% among those 10-14 years, 78% among those 15-17 years, and 69% among those 18-24 years. Prior research has shown that nonadherence to UC medication – defined as proportion of days covered less than 80% – has been associated with a five-fold risk of disease, compared with adherence above 80%, the investigators note.

“If clinicians are unaware of suboptimal adherence to first-line medication, they may incorrectly assume therapy has failed, which may lead to unnecessary escalation in treatment and avoidable steroid use that remains high in UC,” the researchers write.

Psychiatric comorbidity (depression, anxiety, or antidepressant use) was not associated with discontinuation or adherence to treatment.

“As doctors, this study shows we need to be keeping a close eye on patients, particularly within that first year of starting medication,” Dr. Saxena said in the release.

“We should check if these patients are getting their medications and whether they have difficulty paying for them. We should also use the opportunity to talk through any recurring symptoms and how to access advice from providers such as a nurse specialist,” Dr. Saxena said.
 

Effectiveness of therapy in young adults

Reached for comment, Michael Dolinger, MD, assistant professor of pediatric gastroenterology, Icahn School of Medicine and Mount Sinai Kravis Children’s Hospital, both in New York, said he has seen 5-ASA stoppage among his younger patients.

“Generally, what we see is that the majority of patients over time are not able to be sustained on oral mesalamine treatment, and they need a more advanced therapy,” Dr. Dolinger said in an interview.

And while the U.K. study did not delve into the reasons for discontinuation, ineffectiveness of therapy is likely a main cause, Dr. Dolinger said.

“We especially see this in our younger adolescent and young adult patients. In these younger patients, the immune system is potentially driving inflammation a bit more than in older patients, often going beyond the inner lining of the colon to the entire bowel wall, even in ulcerative colitis, and therefore mesalamine may be ineffective over the first year,” Dr. Dolinger explained.

When choosing a more advanced therapy, Dr. Dolinger said, “it’s all about having that conversation in a shared decision-making process about what may be the most effective short- and long-term treatment options with the best safety for that patient. It’s a very individualized discussion.”

“One of the main things we preach and talk about is control of inflammation, getting into early deep remission, because the longer you have inflammation, even if it’s just smoldering, the harder it is to get into deep remission,” Dr. Dolinger added.

The study had no commercial funding. Dr. Saxena, Dr. Ananthakrishnan, and Dr. Dolinger have disclosed no relevant financial relationships.

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

Nearly 70% of adolescents and young adults stop taking oral 5-aminosalicylic acid (5-ASA) maintenance therapy within 12 months of ulcerative colitis (UC) diagnosis, new research from the United Kingdom indicates.

“This is concerning as they are at risk of their condition returning and further complications. It can also lead to severe complications such as surgery to remove part of the gut,” Sonia Saxena, MBBS, director, Imperial Child Health Unit, School of Public Health, Imperial College London, said in a news release.

The study “highlights the importance of counseling and education of patients at diagnosis as this is a critical window that influences long-term health behavior,” Ashwin Ananthakrishnan, MD, MPH, a gastroenterologist with Massachusetts General Hospital and Harvard Medical School, both in Boston, said in an interview.

“It has not been my experience in U.S.-based practice that the rates of discontinuation are that high, but it would be important to examine this in different locations,” added Dr. Ananthakrishnan, who wasn’t involved with the study.

The study was published online in the British Journal of General Practice.
 

Cases on the rise

Globally, the incidence of UC is increasing fastest in younger populations. It’s estimated that up to 30% of individuals with UC are diagnosed in childhood or young adulthood, and these individuals are more likely to have a severe disease course and years living with disability, compared with peers diagnosed later in life. This makes achieving disease control and maintaining remission “paramount” for those diagnosed in early life, Dr. Saxena and colleagues write.

International UC guidelines recommend starting therapy with 5-ASA, also known as mesalamine, soon after diagnosis and continuing it long term to maintain remission. However, some prior evidence suggests that adherence to UC medication may be less optimal in younger people – findings supported by the U.K. study.

Leveraging data from the UK Clinical Practice Research Datalink, Dr. Saxena and colleagues analyzed data for 607 children and young adults aged 10-24 years starting oral 5-ASA maintenance therapy for UC.

They found that 152 individuals (25%) stopped 5-ASA treatment after 1 month, and 419 (69%) discontinued it within 1 year of starting treatment. The median time to stopping the anti-inflammatory drug was 162 days.

Discontinuation rates were highest in young adults aged 18-24 years (74%). The transition to adult care and loss of support from caregivers who encourage adherence in adolescents and provide financial and practical support could be one explanation for this, the researchers write.

After accounting for other factors, young adults aged 18-24 years starting 5-ASA were 43% more likely to discontinue it in the first year than adolescents aged 10-14 years.

Individuals living in socioeconomically deprived areas were 46% more likely to stop treatment, compared with those living in more affluent areas, a finding that suggests the need to address socioeconomic disparities that could drive discontinuation, the authors say.

They also found that early corticosteroid use for an acute UC flare was associated with a 32% lower likelihood of stopping 5-ASA therapy.
 

Adherence falls short

In terms of adherence, defined as the proportion of days covered by 5-ASA medication, the mean was 72%, equivalent to just under 9 months. Adherence fell with older age at initiation of therapy. Adherence was 80% among those 10-14 years, 78% among those 15-17 years, and 69% among those 18-24 years. Prior research has shown that nonadherence to UC medication – defined as proportion of days covered less than 80% – has been associated with a five-fold risk of disease, compared with adherence above 80%, the investigators note.

“If clinicians are unaware of suboptimal adherence to first-line medication, they may incorrectly assume therapy has failed, which may lead to unnecessary escalation in treatment and avoidable steroid use that remains high in UC,” the researchers write.

Psychiatric comorbidity (depression, anxiety, or antidepressant use) was not associated with discontinuation or adherence to treatment.

“As doctors, this study shows we need to be keeping a close eye on patients, particularly within that first year of starting medication,” Dr. Saxena said in the release.

“We should check if these patients are getting their medications and whether they have difficulty paying for them. We should also use the opportunity to talk through any recurring symptoms and how to access advice from providers such as a nurse specialist,” Dr. Saxena said.
 

Effectiveness of therapy in young adults

Reached for comment, Michael Dolinger, MD, assistant professor of pediatric gastroenterology, Icahn School of Medicine and Mount Sinai Kravis Children’s Hospital, both in New York, said he has seen 5-ASA stoppage among his younger patients.

“Generally, what we see is that the majority of patients over time are not able to be sustained on oral mesalamine treatment, and they need a more advanced therapy,” Dr. Dolinger said in an interview.

And while the U.K. study did not delve into the reasons for discontinuation, ineffectiveness of therapy is likely a main cause, Dr. Dolinger said.

“We especially see this in our younger adolescent and young adult patients. In these younger patients, the immune system is potentially driving inflammation a bit more than in older patients, often going beyond the inner lining of the colon to the entire bowel wall, even in ulcerative colitis, and therefore mesalamine may be ineffective over the first year,” Dr. Dolinger explained.

When choosing a more advanced therapy, Dr. Dolinger said, “it’s all about having that conversation in a shared decision-making process about what may be the most effective short- and long-term treatment options with the best safety for that patient. It’s a very individualized discussion.”

“One of the main things we preach and talk about is control of inflammation, getting into early deep remission, because the longer you have inflammation, even if it’s just smoldering, the harder it is to get into deep remission,” Dr. Dolinger added.

The study had no commercial funding. Dr. Saxena, Dr. Ananthakrishnan, and Dr. Dolinger have disclosed no relevant financial relationships.

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

Nearly 70% of adolescents and young adults stop taking oral 5-aminosalicylic acid (5-ASA) maintenance therapy within 12 months of ulcerative colitis (UC) diagnosis, new research from the United Kingdom indicates.

“This is concerning as they are at risk of their condition returning and further complications. It can also lead to severe complications such as surgery to remove part of the gut,” Sonia Saxena, MBBS, director, Imperial Child Health Unit, School of Public Health, Imperial College London, said in a news release.

The study “highlights the importance of counseling and education of patients at diagnosis as this is a critical window that influences long-term health behavior,” Ashwin Ananthakrishnan, MD, MPH, a gastroenterologist with Massachusetts General Hospital and Harvard Medical School, both in Boston, said in an interview.

“It has not been my experience in U.S.-based practice that the rates of discontinuation are that high, but it would be important to examine this in different locations,” added Dr. Ananthakrishnan, who wasn’t involved with the study.

The study was published online in the British Journal of General Practice.
 

Cases on the rise

Globally, the incidence of UC is increasing fastest in younger populations. It’s estimated that up to 30% of individuals with UC are diagnosed in childhood or young adulthood, and these individuals are more likely to have a severe disease course and years living with disability, compared with peers diagnosed later in life. This makes achieving disease control and maintaining remission “paramount” for those diagnosed in early life, Dr. Saxena and colleagues write.

International UC guidelines recommend starting therapy with 5-ASA, also known as mesalamine, soon after diagnosis and continuing it long term to maintain remission. However, some prior evidence suggests that adherence to UC medication may be less optimal in younger people – findings supported by the U.K. study.

Leveraging data from the UK Clinical Practice Research Datalink, Dr. Saxena and colleagues analyzed data for 607 children and young adults aged 10-24 years starting oral 5-ASA maintenance therapy for UC.

They found that 152 individuals (25%) stopped 5-ASA treatment after 1 month, and 419 (69%) discontinued it within 1 year of starting treatment. The median time to stopping the anti-inflammatory drug was 162 days.

Discontinuation rates were highest in young adults aged 18-24 years (74%). The transition to adult care and loss of support from caregivers who encourage adherence in adolescents and provide financial and practical support could be one explanation for this, the researchers write.

After accounting for other factors, young adults aged 18-24 years starting 5-ASA were 43% more likely to discontinue it in the first year than adolescents aged 10-14 years.

Individuals living in socioeconomically deprived areas were 46% more likely to stop treatment, compared with those living in more affluent areas, a finding that suggests the need to address socioeconomic disparities that could drive discontinuation, the authors say.

They also found that early corticosteroid use for an acute UC flare was associated with a 32% lower likelihood of stopping 5-ASA therapy.
 

Adherence falls short

In terms of adherence, defined as the proportion of days covered by 5-ASA medication, the mean was 72%, equivalent to just under 9 months. Adherence fell with older age at initiation of therapy. Adherence was 80% among those 10-14 years, 78% among those 15-17 years, and 69% among those 18-24 years. Prior research has shown that nonadherence to UC medication – defined as proportion of days covered less than 80% – has been associated with a five-fold risk of disease, compared with adherence above 80%, the investigators note.

“If clinicians are unaware of suboptimal adherence to first-line medication, they may incorrectly assume therapy has failed, which may lead to unnecessary escalation in treatment and avoidable steroid use that remains high in UC,” the researchers write.

Psychiatric comorbidity (depression, anxiety, or antidepressant use) was not associated with discontinuation or adherence to treatment.

“As doctors, this study shows we need to be keeping a close eye on patients, particularly within that first year of starting medication,” Dr. Saxena said in the release.

“We should check if these patients are getting their medications and whether they have difficulty paying for them. We should also use the opportunity to talk through any recurring symptoms and how to access advice from providers such as a nurse specialist,” Dr. Saxena said.
 

Effectiveness of therapy in young adults

Reached for comment, Michael Dolinger, MD, assistant professor of pediatric gastroenterology, Icahn School of Medicine and Mount Sinai Kravis Children’s Hospital, both in New York, said he has seen 5-ASA stoppage among his younger patients.

“Generally, what we see is that the majority of patients over time are not able to be sustained on oral mesalamine treatment, and they need a more advanced therapy,” Dr. Dolinger said in an interview.

And while the U.K. study did not delve into the reasons for discontinuation, ineffectiveness of therapy is likely a main cause, Dr. Dolinger said.

“We especially see this in our younger adolescent and young adult patients. In these younger patients, the immune system is potentially driving inflammation a bit more than in older patients, often going beyond the inner lining of the colon to the entire bowel wall, even in ulcerative colitis, and therefore mesalamine may be ineffective over the first year,” Dr. Dolinger explained.

When choosing a more advanced therapy, Dr. Dolinger said, “it’s all about having that conversation in a shared decision-making process about what may be the most effective short- and long-term treatment options with the best safety for that patient. It’s a very individualized discussion.”

“One of the main things we preach and talk about is control of inflammation, getting into early deep remission, because the longer you have inflammation, even if it’s just smoldering, the harder it is to get into deep remission,” Dr. Dolinger added.

The study had no commercial funding. Dr. Saxena, Dr. Ananthakrishnan, and Dr. Dolinger have disclosed no relevant financial relationships.

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

Nonmenstruating women were more likely to experience unexpected vaginal bleeding after receiving COVID-19 vaccinations, according to a new study.

The researchers suggested it could have been connected to the SARS-CoV-2 spike protein in the vaccines. The study was published in Science Advances.

After vaccinations became widely available, many women reported heavier menstrual bleeding than normal. Researchers at the Norwegian Institute of Public Health in Oslo examined the data, particularly among women who do not have periods, such as those who have been through menopause or are taking contraceptives.

The researchers used an ongoing population health survey called the Norwegian Mother, Father, and Child Cohort Study, Nature reported. They examined more than 21,000 responses from postmenopausal, perimenopausal, and nonmenstruating premenopausal women. Some were on long-term hormonal contraceptives.

They learned that 252 postmenopausal women, 1,008 perimenopausal women, and 924 premenopausal women reported having unexpected vaginal bleeding.

About half said the bleeding occurred within 4 weeks of the first or second shot or both. The risk of bleeding was up three to five times for premenopausal and perimenopausal women, and two to three times for postmenopausal women, the researchers found.

Postmenopausal bleeding is usually serious and can be a sign of cancer. “Knowing a patient’s vaccination status could put their bleeding incidence into context,” said Kate Clancy, a biological anthropologist at the University of Illinois at Urbana-Champaign.

The study received funding through the Norwegian Institute of Public Health and Research Council of Norway. The researchers reported no conflicts of interest.

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

Nonmenstruating women were more likely to experience unexpected vaginal bleeding after receiving COVID-19 vaccinations, according to a new study.

The researchers suggested it could have been connected to the SARS-CoV-2 spike protein in the vaccines. The study was published in Science Advances.

After vaccinations became widely available, many women reported heavier menstrual bleeding than normal. Researchers at the Norwegian Institute of Public Health in Oslo examined the data, particularly among women who do not have periods, such as those who have been through menopause or are taking contraceptives.

The researchers used an ongoing population health survey called the Norwegian Mother, Father, and Child Cohort Study, Nature reported. They examined more than 21,000 responses from postmenopausal, perimenopausal, and nonmenstruating premenopausal women. Some were on long-term hormonal contraceptives.

They learned that 252 postmenopausal women, 1,008 perimenopausal women, and 924 premenopausal women reported having unexpected vaginal bleeding.

About half said the bleeding occurred within 4 weeks of the first or second shot or both. The risk of bleeding was up three to five times for premenopausal and perimenopausal women, and two to three times for postmenopausal women, the researchers found.

Postmenopausal bleeding is usually serious and can be a sign of cancer. “Knowing a patient’s vaccination status could put their bleeding incidence into context,” said Kate Clancy, a biological anthropologist at the University of Illinois at Urbana-Champaign.

The study received funding through the Norwegian Institute of Public Health and Research Council of Norway. The researchers reported no conflicts of interest.

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

Nonmenstruating women were more likely to experience unexpected vaginal bleeding after receiving COVID-19 vaccinations, according to a new study.

The researchers suggested it could have been connected to the SARS-CoV-2 spike protein in the vaccines. The study was published in Science Advances.

After vaccinations became widely available, many women reported heavier menstrual bleeding than normal. Researchers at the Norwegian Institute of Public Health in Oslo examined the data, particularly among women who do not have periods, such as those who have been through menopause or are taking contraceptives.

The researchers used an ongoing population health survey called the Norwegian Mother, Father, and Child Cohort Study, Nature reported. They examined more than 21,000 responses from postmenopausal, perimenopausal, and nonmenstruating premenopausal women. Some were on long-term hormonal contraceptives.

They learned that 252 postmenopausal women, 1,008 perimenopausal women, and 924 premenopausal women reported having unexpected vaginal bleeding.

About half said the bleeding occurred within 4 weeks of the first or second shot or both. The risk of bleeding was up three to five times for premenopausal and perimenopausal women, and two to three times for postmenopausal women, the researchers found.

Postmenopausal bleeding is usually serious and can be a sign of cancer. “Knowing a patient’s vaccination status could put their bleeding incidence into context,” said Kate Clancy, a biological anthropologist at the University of Illinois at Urbana-Champaign.

The study received funding through the Norwegian Institute of Public Health and Research Council of Norway. The researchers reported no conflicts of interest.

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

TOPLINE:

Nearly three-quarters of adults with alopecia areata (AA) were not receiving treatment 1 year after diagnosis, according to a retrospective cohort study using data from more than 45,000 individuals.

METHODOLOGY:

• The study population included 45,483 adults aged 18 years and older with new diagnoses of AA between Oct. 15, 2015, and Feb. 28, 2020. Data were from a large U.S. health care database that included medical and pharmacy claims.
• The mean age of the participants was 43.8 years, and 65.7% were female.
• The researchers measured variables that might relate to AA and its treatment patterns within 1 year of starting the study and during the first year of the study, with data collected at 1, 42, 84, and 365 days after study entry.

TAKEAWAYS:

• During the first year after diagnosis, 66.4% of patients received at least one treatment for AA at one or more time points.
• At 1 year, 71.8% of patients were not receiving any active treatment for AA.
• Among those who received treatment, intralesional injections were the most often prescribed therapy (41.8% of patients), followed by topical corticosteroids (40.9%), intramuscular corticosteroids (38.1%), and oral corticosteroids (20.6%).
• Patients diagnosed with either alopecia totalis or alopecia universalis were significantly less likely to receive intralesional steroids and significantly more likely to receive topical corticosteroids than those without these diagnoses (11.1% vs. 44.1% and 25.4% vs. 42.1, respectively).

IN PRACTICE:

The results highlight the need to determine why so many alopecia patients with AA were no longer on treatment after 1 year, although treatment trends may change with the emergence of new therapies, such as JAK inhibitors and others, according to the authors.

SOURCE:

The lead author of the study was Hemin Lee, MD, MPH, Brigham and Women’s Hospital, Boston. The study was published online in JAMA Dermatology.

LIMITATIONS:

The use of insurance claims data did not allow analysis of over-the-counter medications and treatments, and the lack of a single ICD-10 code for defining AA could have resulted in misclassification of outcomes.

DISCLOSURES:

The study received no outside funding, and Dr. Lee had no disclosures. One author had disclosures that included receiving personal fees from Pfizer and Concert outside of the submitted study and participating in alopecia-related trials with Lilly, Concert, Aclaris, and Incyte. Another author’s disclosures included receiving personal fees from companies that included Pfizer, Concert, Lilly, and AbbVie. No other disclosures were reported.

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

TOPLINE:

Nearly three-quarters of adults with alopecia areata (AA) were not receiving treatment 1 year after diagnosis, according to a retrospective cohort study using data from more than 45,000 individuals.

METHODOLOGY:

• The study population included 45,483 adults aged 18 years and older with new diagnoses of AA between Oct. 15, 2015, and Feb. 28, 2020. Data were from a large U.S. health care database that included medical and pharmacy claims.
• The mean age of the participants was 43.8 years, and 65.7% were female.
• The researchers measured variables that might relate to AA and its treatment patterns within 1 year of starting the study and during the first year of the study, with data collected at 1, 42, 84, and 365 days after study entry.

TAKEAWAYS:

• During the first year after diagnosis, 66.4% of patients received at least one treatment for AA at one or more time points.
• At 1 year, 71.8% of patients were not receiving any active treatment for AA.
• Among those who received treatment, intralesional injections were the most often prescribed therapy (41.8% of patients), followed by topical corticosteroids (40.9%), intramuscular corticosteroids (38.1%), and oral corticosteroids (20.6%).
• Patients diagnosed with either alopecia totalis or alopecia universalis were significantly less likely to receive intralesional steroids and significantly more likely to receive topical corticosteroids than those without these diagnoses (11.1% vs. 44.1% and 25.4% vs. 42.1, respectively).

IN PRACTICE:

The results highlight the need to determine why so many alopecia patients with AA were no longer on treatment after 1 year, although treatment trends may change with the emergence of new therapies, such as JAK inhibitors and others, according to the authors.

SOURCE:

The lead author of the study was Hemin Lee, MD, MPH, Brigham and Women’s Hospital, Boston. The study was published online in JAMA Dermatology.

LIMITATIONS:

The use of insurance claims data did not allow analysis of over-the-counter medications and treatments, and the lack of a single ICD-10 code for defining AA could have resulted in misclassification of outcomes.

DISCLOSURES:

The study received no outside funding, and Dr. Lee had no disclosures. One author had disclosures that included receiving personal fees from Pfizer and Concert outside of the submitted study and participating in alopecia-related trials with Lilly, Concert, Aclaris, and Incyte. Another author’s disclosures included receiving personal fees from companies that included Pfizer, Concert, Lilly, and AbbVie. No other disclosures were reported.

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

TOPLINE:

Nearly three-quarters of adults with alopecia areata (AA) were not receiving treatment 1 year after diagnosis, according to a retrospective cohort study using data from more than 45,000 individuals.

METHODOLOGY:

• The study population included 45,483 adults aged 18 years and older with new diagnoses of AA between Oct. 15, 2015, and Feb. 28, 2020. Data were from a large U.S. health care database that included medical and pharmacy claims.
• The mean age of the participants was 43.8 years, and 65.7% were female.
• The researchers measured variables that might relate to AA and its treatment patterns within 1 year of starting the study and during the first year of the study, with data collected at 1, 42, 84, and 365 days after study entry.

TAKEAWAYS:

• During the first year after diagnosis, 66.4% of patients received at least one treatment for AA at one or more time points.
• At 1 year, 71.8% of patients were not receiving any active treatment for AA.
• Among those who received treatment, intralesional injections were the most often prescribed therapy (41.8% of patients), followed by topical corticosteroids (40.9%), intramuscular corticosteroids (38.1%), and oral corticosteroids (20.6%).
• Patients diagnosed with either alopecia totalis or alopecia universalis were significantly less likely to receive intralesional steroids and significantly more likely to receive topical corticosteroids than those without these diagnoses (11.1% vs. 44.1% and 25.4% vs. 42.1, respectively).

IN PRACTICE:

The results highlight the need to determine why so many alopecia patients with AA were no longer on treatment after 1 year, although treatment trends may change with the emergence of new therapies, such as JAK inhibitors and others, according to the authors.

SOURCE:

The lead author of the study was Hemin Lee, MD, MPH, Brigham and Women’s Hospital, Boston. The study was published online in JAMA Dermatology.

LIMITATIONS:

The use of insurance claims data did not allow analysis of over-the-counter medications and treatments, and the lack of a single ICD-10 code for defining AA could have resulted in misclassification of outcomes.

DISCLOSURES:

The study received no outside funding, and Dr. Lee had no disclosures. One author had disclosures that included receiving personal fees from Pfizer and Concert outside of the submitted study and participating in alopecia-related trials with Lilly, Concert, Aclaris, and Incyte. Another author’s disclosures included receiving personal fees from companies that included Pfizer, Concert, Lilly, and AbbVie. No other disclosures were reported.

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

TOPLINE:

Patients older than age 70 years have a 23% lower risk of a first major vascular events with each 1 mmol/L lowering of low-density lipoprotein (LDL) cholesterol, which is similar to the benefit seen among younger patients in primary prevention, new research shows.

METHODOLOGY:

• Using various cross-linked Danish registries, researchers analyzed 65,190 participants aged 50 years and older (49,155 aged 50-69 and 16,035 aged 70+) without a history of atherosclerotic cardiovascular disease (ASCVD) who initiated new lipid-lowering treatment and had a baseline LDL cholesterol measurement and a subsequent measurement within a year.
• The primary outcome was hospitalization for a major vascular event, defined as a composite of acute coronary syndrome, nonhemorrhagic stroke, and coronary revascularization. Secondary outcomes included individual cardiovascular components of the primary outcome and all-cause mortality.

TAKEAWAY:

• During a median follow-up of 2.5 years, 626 older (70 years and over) and 1,123 younger (aged 50-69) participants had a major vascular event, with crude incidence rates of 13.4 and 7.1 per 1000 person-years, respectively.
• After adjustment for potential confounders, each 1-mmol/L reduction in LDL cholesterol in people aged 70 and older was associated with a significant 23% lower risk for major vascular events (hazard ratio [HR] 0.77; 95% confidence interval [CI], 0.71-0.83), similar to results for those younger than 70 (HR, 0.76; 95% CI, 0.71-0.80; P value for the difference between the age groups, 0.79).
• Results across all cardiovascular secondary analyses supported the main findings, and there was no significant difference between older and younger participants across all subgroup analyses, including using 75 years as the age cutoff.
• There was no association with all-cause mortality for either the older (HR, 1.03; 95% CI, 0.98-1.09) or younger (HR, 1.00; 95% CI, 0.95-1.06) groups.

IN PRACTICE:

“Our results, based on a substantial sample size representative of a contemporary general population, may contribute to informing future guideline recommendations,” and to discussions with older patients about the benefits of LDL lowering therapy, the authors wrote. They stressed that any potential benefits should be balanced against potential harms in this population, as these individuals may have comorbidities and may be taking multiple medications.

In an accompanying editorial, Safi U. Khan, MD, from the department of cardiology at Houston Methodist DeBakey Heart and Vascular Center, said the study “contributes valuable insights regarding the effects of LDL-C-lowering therapy, especially as the burgeoning aging population faces escalating burden of ASCVD,” and added future research “should focus on corroborating these findings and addressing the safety of lipid-lowering treatments in older individuals.”
 

SOURCE:

The study was conducted by Niklas Worm Andersson, MD, department of epidemiology research, Statens Serum Institut, Copenhagen, and colleagues. It was published online Journal of the American College of Cardiology.

LIMITATIONS:

The results may not apply to individuals without LDL monitoring when receiving lipid-lowering treatment. Outcomes relied on the validity of recorded diagnostic codes in the registries, and medical record review of cases was not done. Residual confounding can’t be ruled out, in part because data on potentially important risk factors such as smoking, blood pressure, and body mass index weren’t available. The results may not generalize to clinical scenarios or subpopulations not directly studied.

DISCLOSURES:

Dr. Andersson has no relevant conflicts of interest. Author Tine Lovsø Dohlmann, PhD, was employed by Statens Serum Institut during the study, but has been employed by Novo Nordisk since January 2023. All other study authors and the editorialist Dr. Khan have no relevant conflicts of interest.

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

TOPLINE:

Patients older than age 70 years have a 23% lower risk of a first major vascular events with each 1 mmol/L lowering of low-density lipoprotein (LDL) cholesterol, which is similar to the benefit seen among younger patients in primary prevention, new research shows.

METHODOLOGY:

• Using various cross-linked Danish registries, researchers analyzed 65,190 participants aged 50 years and older (49,155 aged 50-69 and 16,035 aged 70+) without a history of atherosclerotic cardiovascular disease (ASCVD) who initiated new lipid-lowering treatment and had a baseline LDL cholesterol measurement and a subsequent measurement within a year.
• The primary outcome was hospitalization for a major vascular event, defined as a composite of acute coronary syndrome, nonhemorrhagic stroke, and coronary revascularization. Secondary outcomes included individual cardiovascular components of the primary outcome and all-cause mortality.

TAKEAWAY:

• During a median follow-up of 2.5 years, 626 older (70 years and over) and 1,123 younger (aged 50-69) participants had a major vascular event, with crude incidence rates of 13.4 and 7.1 per 1000 person-years, respectively.
• After adjustment for potential confounders, each 1-mmol/L reduction in LDL cholesterol in people aged 70 and older was associated with a significant 23% lower risk for major vascular events (hazard ratio [HR] 0.77; 95% confidence interval [CI], 0.71-0.83), similar to results for those younger than 70 (HR, 0.76; 95% CI, 0.71-0.80; P value for the difference between the age groups, 0.79).
• Results across all cardiovascular secondary analyses supported the main findings, and there was no significant difference between older and younger participants across all subgroup analyses, including using 75 years as the age cutoff.
• There was no association with all-cause mortality for either the older (HR, 1.03; 95% CI, 0.98-1.09) or younger (HR, 1.00; 95% CI, 0.95-1.06) groups.

IN PRACTICE:

“Our results, based on a substantial sample size representative of a contemporary general population, may contribute to informing future guideline recommendations,” and to discussions with older patients about the benefits of LDL lowering therapy, the authors wrote. They stressed that any potential benefits should be balanced against potential harms in this population, as these individuals may have comorbidities and may be taking multiple medications.

In an accompanying editorial, Safi U. Khan, MD, from the department of cardiology at Houston Methodist DeBakey Heart and Vascular Center, said the study “contributes valuable insights regarding the effects of LDL-C-lowering therapy, especially as the burgeoning aging population faces escalating burden of ASCVD,” and added future research “should focus on corroborating these findings and addressing the safety of lipid-lowering treatments in older individuals.”
 

SOURCE:

The study was conducted by Niklas Worm Andersson, MD, department of epidemiology research, Statens Serum Institut, Copenhagen, and colleagues. It was published online Journal of the American College of Cardiology.

LIMITATIONS:

The results may not apply to individuals without LDL monitoring when receiving lipid-lowering treatment. Outcomes relied on the validity of recorded diagnostic codes in the registries, and medical record review of cases was not done. Residual confounding can’t be ruled out, in part because data on potentially important risk factors such as smoking, blood pressure, and body mass index weren’t available. The results may not generalize to clinical scenarios or subpopulations not directly studied.

DISCLOSURES:

Dr. Andersson has no relevant conflicts of interest. Author Tine Lovsø Dohlmann, PhD, was employed by Statens Serum Institut during the study, but has been employed by Novo Nordisk since January 2023. All other study authors and the editorialist Dr. Khan have no relevant conflicts of interest.

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

TOPLINE:

Patients older than age 70 years have a 23% lower risk of a first major vascular events with each 1 mmol/L lowering of low-density lipoprotein (LDL) cholesterol, which is similar to the benefit seen among younger patients in primary prevention, new research shows.

METHODOLOGY:

• Using various cross-linked Danish registries, researchers analyzed 65,190 participants aged 50 years and older (49,155 aged 50-69 and 16,035 aged 70+) without a history of atherosclerotic cardiovascular disease (ASCVD) who initiated new lipid-lowering treatment and had a baseline LDL cholesterol measurement and a subsequent measurement within a year.
• The primary outcome was hospitalization for a major vascular event, defined as a composite of acute coronary syndrome, nonhemorrhagic stroke, and coronary revascularization. Secondary outcomes included individual cardiovascular components of the primary outcome and all-cause mortality.

TAKEAWAY:

• During a median follow-up of 2.5 years, 626 older (70 years and over) and 1,123 younger (aged 50-69) participants had a major vascular event, with crude incidence rates of 13.4 and 7.1 per 1000 person-years, respectively.
• After adjustment for potential confounders, each 1-mmol/L reduction in LDL cholesterol in people aged 70 and older was associated with a significant 23% lower risk for major vascular events (hazard ratio [HR] 0.77; 95% confidence interval [CI], 0.71-0.83), similar to results for those younger than 70 (HR, 0.76; 95% CI, 0.71-0.80; P value for the difference between the age groups, 0.79).
• Results across all cardiovascular secondary analyses supported the main findings, and there was no significant difference between older and younger participants across all subgroup analyses, including using 75 years as the age cutoff.
• There was no association with all-cause mortality for either the older (HR, 1.03; 95% CI, 0.98-1.09) or younger (HR, 1.00; 95% CI, 0.95-1.06) groups.

IN PRACTICE:

“Our results, based on a substantial sample size representative of a contemporary general population, may contribute to informing future guideline recommendations,” and to discussions with older patients about the benefits of LDL lowering therapy, the authors wrote. They stressed that any potential benefits should be balanced against potential harms in this population, as these individuals may have comorbidities and may be taking multiple medications.

In an accompanying editorial, Safi U. Khan, MD, from the department of cardiology at Houston Methodist DeBakey Heart and Vascular Center, said the study “contributes valuable insights regarding the effects of LDL-C-lowering therapy, especially as the burgeoning aging population faces escalating burden of ASCVD,” and added future research “should focus on corroborating these findings and addressing the safety of lipid-lowering treatments in older individuals.”
 

SOURCE:

The study was conducted by Niklas Worm Andersson, MD, department of epidemiology research, Statens Serum Institut, Copenhagen, and colleagues. It was published online Journal of the American College of Cardiology.

LIMITATIONS:

The results may not apply to individuals without LDL monitoring when receiving lipid-lowering treatment. Outcomes relied on the validity of recorded diagnostic codes in the registries, and medical record review of cases was not done. Residual confounding can’t be ruled out, in part because data on potentially important risk factors such as smoking, blood pressure, and body mass index weren’t available. The results may not generalize to clinical scenarios or subpopulations not directly studied.

DISCLOSURES:

Dr. Andersson has no relevant conflicts of interest. Author Tine Lovsø Dohlmann, PhD, was employed by Statens Serum Institut during the study, but has been employed by Novo Nordisk since January 2023. All other study authors and the editorialist Dr. Khan have no relevant conflicts of interest.

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

People with long COVID have specific biomarkers in their blood, according to results of a study published in Nature. 

The findings may be a step toward creating blood tests to positively identify people with long COVID so specialized treatments can be employed, researchers said.

 “This is a decisive step forward in the development of valid and reliable blood testing protocols for long COVID,” said David Putrino, PhD., lead author and professor of rehabilitation and human performance and director of the Abilities Research Center at Icahn Mount Sinai Health System, New York.

Researchers from the Icahn School of Medicine at Mount Sinai and Yale School of Medicine looked at blood samples from about 270 people between January 2021 and June 2022. The people had never been infected with COVID, had fully recovered from an infection, or still showed symptoms at least four months after infection.

Using machine learning, the research teams were able to differentiate between people with and without long COVID with 96% accuracy based on distinctive features in the blood samples, according to a news release from Mount Sinai.

People with long COVID had abnormal T-cell activity and low levels of the hormone cortisol. Cortisol helps people feel alert and awake, which would explain why people with long COVID often report fatigue, NBC News said in a report on the study.

“It was one of the findings that most definitively separated the folks with long Covid from the people without long Covid,” Dr. Putrino told NBC News.

The study also found that long COVID appears to reactivate latent viruses including Epstein-Barr and mononucleosis, the study said.

The blood tests could allow doctors to come up with specialized treatments in people who report a wide variety of long COVID symptoms, Dr. Putrino said. 

“There is no ‘silver bullet’ for treating long COVID, because it is an illness that infiltrates complex systems such as the immune and hormonal regulation,” he said.

The Centers for Disease Control and Prevention says about one in five Americans who had COVID still have long COVID. Symptoms include fatigue, brain fog, dizziness, digestive problems, and loss of smell and taste.

A version of this article appeared on WebMD.com.

People with long COVID have specific biomarkers in their blood, according to results of a study published in Nature. 

The findings may be a step toward creating blood tests to positively identify people with long COVID so specialized treatments can be employed, researchers said.

 “This is a decisive step forward in the development of valid and reliable blood testing protocols for long COVID,” said David Putrino, PhD., lead author and professor of rehabilitation and human performance and director of the Abilities Research Center at Icahn Mount Sinai Health System, New York.

Researchers from the Icahn School of Medicine at Mount Sinai and Yale School of Medicine looked at blood samples from about 270 people between January 2021 and June 2022. The people had never been infected with COVID, had fully recovered from an infection, or still showed symptoms at least four months after infection.

Using machine learning, the research teams were able to differentiate between people with and without long COVID with 96% accuracy based on distinctive features in the blood samples, according to a news release from Mount Sinai.

People with long COVID had abnormal T-cell activity and low levels of the hormone cortisol. Cortisol helps people feel alert and awake, which would explain why people with long COVID often report fatigue, NBC News said in a report on the study.

“It was one of the findings that most definitively separated the folks with long Covid from the people without long Covid,” Dr. Putrino told NBC News.

The study also found that long COVID appears to reactivate latent viruses including Epstein-Barr and mononucleosis, the study said.

The blood tests could allow doctors to come up with specialized treatments in people who report a wide variety of long COVID symptoms, Dr. Putrino said. 

“There is no ‘silver bullet’ for treating long COVID, because it is an illness that infiltrates complex systems such as the immune and hormonal regulation,” he said.

The Centers for Disease Control and Prevention says about one in five Americans who had COVID still have long COVID. Symptoms include fatigue, brain fog, dizziness, digestive problems, and loss of smell and taste.

A version of this article appeared on WebMD.com.

People with long COVID have specific biomarkers in their blood, according to results of a study published in Nature. 

The findings may be a step toward creating blood tests to positively identify people with long COVID so specialized treatments can be employed, researchers said.

 “This is a decisive step forward in the development of valid and reliable blood testing protocols for long COVID,” said David Putrino, PhD., lead author and professor of rehabilitation and human performance and director of the Abilities Research Center at Icahn Mount Sinai Health System, New York.

Researchers from the Icahn School of Medicine at Mount Sinai and Yale School of Medicine looked at blood samples from about 270 people between January 2021 and June 2022. The people had never been infected with COVID, had fully recovered from an infection, or still showed symptoms at least four months after infection.

Using machine learning, the research teams were able to differentiate between people with and without long COVID with 96% accuracy based on distinctive features in the blood samples, according to a news release from Mount Sinai.

People with long COVID had abnormal T-cell activity and low levels of the hormone cortisol. Cortisol helps people feel alert and awake, which would explain why people with long COVID often report fatigue, NBC News said in a report on the study.

“It was one of the findings that most definitively separated the folks with long Covid from the people without long Covid,” Dr. Putrino told NBC News.

The study also found that long COVID appears to reactivate latent viruses including Epstein-Barr and mononucleosis, the study said.

The blood tests could allow doctors to come up with specialized treatments in people who report a wide variety of long COVID symptoms, Dr. Putrino said. 

“There is no ‘silver bullet’ for treating long COVID, because it is an illness that infiltrates complex systems such as the immune and hormonal regulation,” he said.

The Centers for Disease Control and Prevention says about one in five Americans who had COVID still have long COVID. Symptoms include fatigue, brain fog, dizziness, digestive problems, and loss of smell and taste.

A version of this article appeared on WebMD.com.

Patients with confirmed nonerosive gastroesophageal reflux disease (GERD) are not at greater risk for esophageal cancer compared with the general population and are unlikely to need additional endoscopic monitoring for cancer, new research suggests.

By contrast, patients with erosive disease had more than double the incidence of esophageal cancer.

“We expected a less-strong association with cancer among patients with nonerosive GERD compared to those with erosive GERD, [and] the results do make sense in view of the fact that the nonerosive GERD patients had normal esophageal mucosa at endoscopy,” Jesper Lagergren, MD, PhD, of Karolinska Institutet, Stockholm, told this news organization.

The findings “suggest that in patients with GERD, a normal endoscopy indicates that the risk of cancer development in the esophagus is low,” he said. “If future research confirms our results, no monitoring would be needed for patients with known nonerosive GERD.”

However, a related editorial suggests there may be other reasons to endoscopically monitor patients with nonerosive GERD.

The study was published online in the BMJ, as was the editorial.
 

Erosive GERD raises risk

To assess the incidence rate of esophageal cancer among patients with nonerosive GERD compared with the general population, the investigators analyzed records from 486,556 patients in hospital and specialized outpatient centers in Denmark, Finland, and Sweden who underwent endoscopy from 1987 to 2019.

A total of 285,811 patients were included in the nonerosive GERD cohort, and 200,745 were included in a validation cohort of patients with erosive GERD.

Nonerosive GERD was defined by the absence of esophagitis and any other esophageal disorder at endoscopy. Erosive GERD was defined by esophagitis at endoscopy.

The incidence rate of esophageal cancer was assessed for up to 31 years of follow-up, with the median being 6.3 years.

In the nonerosive GERD cohort, 228 patients developed esophageal cancer during nearly 2.1 million person-years of follow-up. The incidence rate was 11 per 100,000 person-years, similar to that of the general population (standardized incidence ratio, 1.04) and did not increase with longer follow-up.

In the erosive GERD cohort, 542 patients developed esophageal cancer over almost 1.8 million person-years. This corresponded to an incidence rate of 31 per 100,000 person-years, or an increased overall standardized incidence ratio of 2.36, which became more pronounced with longer follow-up.

“This finding suggests that endoscopically confirmed non-erosive [GERD] does not require additional endoscopic monitoring for esophageal adenocarcinoma,” the authors concluded.
 

‘Dynamic’ progression

In a related editorial, Jerry Zhou, PhD, and Vincent Ho, MD, both of Western Sydney University, Penrith, New South Wales, Australia, wrote that the finding that patients with nonerosive disease do not have to undergo additional endoscopic evaluations for cancer is in line with previous research.

However, they added, “the more pressing rationale for reevaluating these patients would be the potential for progression to conditions such as erosive reflux disease or Barrett’s esophagus.” Longitudinal studies have shown that GERD progression is dynamic, and so the development of erosive disease after nonerosive disease is feasible.

“Widespread use of proton-pump inhibitors complicates our understanding” of GERD progression, they noted. Although study participants were advised not to take antireflux medications in the weeks prior to their endoscopy, “uncertainties about previous treatments remain due to the study’s design.” Some participants without erosive disease at baseline may have had it in the past.

Dr. Zhou and Dr. Ho also postulated that rather than being a progressive disease, nonerosive and erosive GERD might be two distinct conditions with different features and underpinnings.

Although valuable, the study “prompts reflection on the limitations of relying on the absence of esophageal erosions as the sole diagnostic criterion for non-erosive disease. The changing progression of gastroesophageal reflux disease, the complex influence of proton pump inhibitors, and the potential for a range of underlying pathophysiological causes requires a more comprehensive diagnostic perspective,” they concluded.

Dr. Lagergren said that his group plans to assess whether treatment of nonerosive GERD should be different from erosive GERD.

The study was funded by the Swedish Research Council, Swedish Cancer Society, and Nordic Cancer Union. No competing interests were declared.
 

A version of this article appeared on Medscape.com.

Patients with confirmed nonerosive gastroesophageal reflux disease (GERD) are not at greater risk for esophageal cancer compared with the general population and are unlikely to need additional endoscopic monitoring for cancer, new research suggests.

By contrast, patients with erosive disease had more than double the incidence of esophageal cancer.

“We expected a less-strong association with cancer among patients with nonerosive GERD compared to those with erosive GERD, [and] the results do make sense in view of the fact that the nonerosive GERD patients had normal esophageal mucosa at endoscopy,” Jesper Lagergren, MD, PhD, of Karolinska Institutet, Stockholm, told this news organization.

The findings “suggest that in patients with GERD, a normal endoscopy indicates that the risk of cancer development in the esophagus is low,” he said. “If future research confirms our results, no monitoring would be needed for patients with known nonerosive GERD.”

However, a related editorial suggests there may be other reasons to endoscopically monitor patients with nonerosive GERD.

The study was published online in the BMJ, as was the editorial.
 

Erosive GERD raises risk

To assess the incidence rate of esophageal cancer among patients with nonerosive GERD compared with the general population, the investigators analyzed records from 486,556 patients in hospital and specialized outpatient centers in Denmark, Finland, and Sweden who underwent endoscopy from 1987 to 2019.

A total of 285,811 patients were included in the nonerosive GERD cohort, and 200,745 were included in a validation cohort of patients with erosive GERD.

Nonerosive GERD was defined by the absence of esophagitis and any other esophageal disorder at endoscopy. Erosive GERD was defined by esophagitis at endoscopy.

The incidence rate of esophageal cancer was assessed for up to 31 years of follow-up, with the median being 6.3 years.

In the nonerosive GERD cohort, 228 patients developed esophageal cancer during nearly 2.1 million person-years of follow-up. The incidence rate was 11 per 100,000 person-years, similar to that of the general population (standardized incidence ratio, 1.04) and did not increase with longer follow-up.

In the erosive GERD cohort, 542 patients developed esophageal cancer over almost 1.8 million person-years. This corresponded to an incidence rate of 31 per 100,000 person-years, or an increased overall standardized incidence ratio of 2.36, which became more pronounced with longer follow-up.

“This finding suggests that endoscopically confirmed non-erosive [GERD] does not require additional endoscopic monitoring for esophageal adenocarcinoma,” the authors concluded.
 

‘Dynamic’ progression

In a related editorial, Jerry Zhou, PhD, and Vincent Ho, MD, both of Western Sydney University, Penrith, New South Wales, Australia, wrote that the finding that patients with nonerosive disease do not have to undergo additional endoscopic evaluations for cancer is in line with previous research.

However, they added, “the more pressing rationale for reevaluating these patients would be the potential for progression to conditions such as erosive reflux disease or Barrett’s esophagus.” Longitudinal studies have shown that GERD progression is dynamic, and so the development of erosive disease after nonerosive disease is feasible.

“Widespread use of proton-pump inhibitors complicates our understanding” of GERD progression, they noted. Although study participants were advised not to take antireflux medications in the weeks prior to their endoscopy, “uncertainties about previous treatments remain due to the study’s design.” Some participants without erosive disease at baseline may have had it in the past.

Dr. Zhou and Dr. Ho also postulated that rather than being a progressive disease, nonerosive and erosive GERD might be two distinct conditions with different features and underpinnings.

Although valuable, the study “prompts reflection on the limitations of relying on the absence of esophageal erosions as the sole diagnostic criterion for non-erosive disease. The changing progression of gastroesophageal reflux disease, the complex influence of proton pump inhibitors, and the potential for a range of underlying pathophysiological causes requires a more comprehensive diagnostic perspective,” they concluded.

Dr. Lagergren said that his group plans to assess whether treatment of nonerosive GERD should be different from erosive GERD.

The study was funded by the Swedish Research Council, Swedish Cancer Society, and Nordic Cancer Union. No competing interests were declared.
 

A version of this article appeared on Medscape.com.

Patients with confirmed nonerosive gastroesophageal reflux disease (GERD) are not at greater risk for esophageal cancer compared with the general population and are unlikely to need additional endoscopic monitoring for cancer, new research suggests.

By contrast, patients with erosive disease had more than double the incidence of esophageal cancer.

“We expected a less-strong association with cancer among patients with nonerosive GERD compared to those with erosive GERD, [and] the results do make sense in view of the fact that the nonerosive GERD patients had normal esophageal mucosa at endoscopy,” Jesper Lagergren, MD, PhD, of Karolinska Institutet, Stockholm, told this news organization.

The findings “suggest that in patients with GERD, a normal endoscopy indicates that the risk of cancer development in the esophagus is low,” he said. “If future research confirms our results, no monitoring would be needed for patients with known nonerosive GERD.”

However, a related editorial suggests there may be other reasons to endoscopically monitor patients with nonerosive GERD.

The study was published online in the BMJ, as was the editorial.
 

Erosive GERD raises risk

To assess the incidence rate of esophageal cancer among patients with nonerosive GERD compared with the general population, the investigators analyzed records from 486,556 patients in hospital and specialized outpatient centers in Denmark, Finland, and Sweden who underwent endoscopy from 1987 to 2019.

A total of 285,811 patients were included in the nonerosive GERD cohort, and 200,745 were included in a validation cohort of patients with erosive GERD.

Nonerosive GERD was defined by the absence of esophagitis and any other esophageal disorder at endoscopy. Erosive GERD was defined by esophagitis at endoscopy.

The incidence rate of esophageal cancer was assessed for up to 31 years of follow-up, with the median being 6.3 years.

In the nonerosive GERD cohort, 228 patients developed esophageal cancer during nearly 2.1 million person-years of follow-up. The incidence rate was 11 per 100,000 person-years, similar to that of the general population (standardized incidence ratio, 1.04) and did not increase with longer follow-up.

In the erosive GERD cohort, 542 patients developed esophageal cancer over almost 1.8 million person-years. This corresponded to an incidence rate of 31 per 100,000 person-years, or an increased overall standardized incidence ratio of 2.36, which became more pronounced with longer follow-up.

“This finding suggests that endoscopically confirmed non-erosive [GERD] does not require additional endoscopic monitoring for esophageal adenocarcinoma,” the authors concluded.
 

‘Dynamic’ progression

In a related editorial, Jerry Zhou, PhD, and Vincent Ho, MD, both of Western Sydney University, Penrith, New South Wales, Australia, wrote that the finding that patients with nonerosive disease do not have to undergo additional endoscopic evaluations for cancer is in line with previous research.

However, they added, “the more pressing rationale for reevaluating these patients would be the potential for progression to conditions such as erosive reflux disease or Barrett’s esophagus.” Longitudinal studies have shown that GERD progression is dynamic, and so the development of erosive disease after nonerosive disease is feasible.

“Widespread use of proton-pump inhibitors complicates our understanding” of GERD progression, they noted. Although study participants were advised not to take antireflux medications in the weeks prior to their endoscopy, “uncertainties about previous treatments remain due to the study’s design.” Some participants without erosive disease at baseline may have had it in the past.

Dr. Zhou and Dr. Ho also postulated that rather than being a progressive disease, nonerosive and erosive GERD might be two distinct conditions with different features and underpinnings.

Although valuable, the study “prompts reflection on the limitations of relying on the absence of esophageal erosions as the sole diagnostic criterion for non-erosive disease. The changing progression of gastroesophageal reflux disease, the complex influence of proton pump inhibitors, and the potential for a range of underlying pathophysiological causes requires a more comprehensive diagnostic perspective,” they concluded.

Dr. Lagergren said that his group plans to assess whether treatment of nonerosive GERD should be different from erosive GERD.

The study was funded by the Swedish Research Council, Swedish Cancer Society, and Nordic Cancer Union. No competing interests were declared.
 

A version of this article appeared on Medscape.com.

The antiviral COVID medication made by Merck can cause mutations in the coronavirus that occasionally spread to other people, according to a study published in the online journal Nature.

There’s no evidence that molnupiravir, sold under the brand name Lagevrio, has caused the creation of more transmissible or severe variants of COVID, the study says, but researchers called for more scrutiny of the drug.

Researchers looked at 15 million COVID genomes and discovered that hallmark mutations linked to molnupiravir increased in 2022, especially in places where the drug was widely used, such as the United States and the United Kingdom. Levels of the mutations were also found in populations where the drug was heavily prescribed, such as seniors.

Molnupiravir is an antiviral given to people after they show signs of having COVID-19. It interferes with the COVID-19 virus’s ability to make copies of itself, thus stopping the spread of the virus throughout the body and keeping the virus level low.

The study found the virus can sometimes survive molnupiravir, resulting in mutations that have spread to other people.

Theo Sanderson, PhD, the lead author on the study and a postdoctoral researcher at the Francis Crick Institute in London, told The Guardian that the implications of the mutations were unclear.

“The signature is very clear, but there aren’t any widely circulating variants that have the signature. At the moment there’s nothing that’s transmitted very widely that’s due to molnupiravir,” he said.

The study doesn’t say people should not use molnupiravir but calls for public health officials to scrutinize it.

“The observation that molnupiravir treatment has left a visible trace in global sequencing databases, including onwards transmission of molnupiravir-derived sequences, will be an important consideration for assessing the effects and evolutionary safety of this drug,” the researchers concluded.

When reached for comment, Merck questioned the evidence.

“The authors assume these mutations were associated with viral spread from molnupiravir-treated patients without documented evidence of that transmission. Instead, the authors rely on circumstantial associations between the region from which the sequence was identified and time frame of sequence collection in countries where molnupiravir is available to draw their conclusions,” the company said.

The Food and Drug Administration authorized the use of molnupiravir for the treatment of mild to moderate COVID-19 in adults in December 2021. The FDA has also authorized the use of nirmatrelvir/ritonavir (Paxlovid), an antiviral made by Pfizer.

A version of this article appeared on WebMD.com.

The antiviral COVID medication made by Merck can cause mutations in the coronavirus that occasionally spread to other people, according to a study published in the online journal Nature.

There’s no evidence that molnupiravir, sold under the brand name Lagevrio, has caused the creation of more transmissible or severe variants of COVID, the study says, but researchers called for more scrutiny of the drug.

Researchers looked at 15 million COVID genomes and discovered that hallmark mutations linked to molnupiravir increased in 2022, especially in places where the drug was widely used, such as the United States and the United Kingdom. Levels of the mutations were also found in populations where the drug was heavily prescribed, such as seniors.

Molnupiravir is an antiviral given to people after they show signs of having COVID-19. It interferes with the COVID-19 virus’s ability to make copies of itself, thus stopping the spread of the virus throughout the body and keeping the virus level low.

The study found the virus can sometimes survive molnupiravir, resulting in mutations that have spread to other people.

Theo Sanderson, PhD, the lead author on the study and a postdoctoral researcher at the Francis Crick Institute in London, told The Guardian that the implications of the mutations were unclear.

“The signature is very clear, but there aren’t any widely circulating variants that have the signature. At the moment there’s nothing that’s transmitted very widely that’s due to molnupiravir,” he said.

The study doesn’t say people should not use molnupiravir but calls for public health officials to scrutinize it.

“The observation that molnupiravir treatment has left a visible trace in global sequencing databases, including onwards transmission of molnupiravir-derived sequences, will be an important consideration for assessing the effects and evolutionary safety of this drug,” the researchers concluded.

When reached for comment, Merck questioned the evidence.

“The authors assume these mutations were associated with viral spread from molnupiravir-treated patients without documented evidence of that transmission. Instead, the authors rely on circumstantial associations between the region from which the sequence was identified and time frame of sequence collection in countries where molnupiravir is available to draw their conclusions,” the company said.

The Food and Drug Administration authorized the use of molnupiravir for the treatment of mild to moderate COVID-19 in adults in December 2021. The FDA has also authorized the use of nirmatrelvir/ritonavir (Paxlovid), an antiviral made by Pfizer.

A version of this article appeared on WebMD.com.

The antiviral COVID medication made by Merck can cause mutations in the coronavirus that occasionally spread to other people, according to a study published in the online journal Nature.

There’s no evidence that molnupiravir, sold under the brand name Lagevrio, has caused the creation of more transmissible or severe variants of COVID, the study says, but researchers called for more scrutiny of the drug.

Researchers looked at 15 million COVID genomes and discovered that hallmark mutations linked to molnupiravir increased in 2022, especially in places where the drug was widely used, such as the United States and the United Kingdom. Levels of the mutations were also found in populations where the drug was heavily prescribed, such as seniors.

Molnupiravir is an antiviral given to people after they show signs of having COVID-19. It interferes with the COVID-19 virus’s ability to make copies of itself, thus stopping the spread of the virus throughout the body and keeping the virus level low.

The study found the virus can sometimes survive molnupiravir, resulting in mutations that have spread to other people.

Theo Sanderson, PhD, the lead author on the study and a postdoctoral researcher at the Francis Crick Institute in London, told The Guardian that the implications of the mutations were unclear.

“The signature is very clear, but there aren’t any widely circulating variants that have the signature. At the moment there’s nothing that’s transmitted very widely that’s due to molnupiravir,” he said.

The study doesn’t say people should not use molnupiravir but calls for public health officials to scrutinize it.

“The observation that molnupiravir treatment has left a visible trace in global sequencing databases, including onwards transmission of molnupiravir-derived sequences, will be an important consideration for assessing the effects and evolutionary safety of this drug,” the researchers concluded.

When reached for comment, Merck questioned the evidence.

“The authors assume these mutations were associated with viral spread from molnupiravir-treated patients without documented evidence of that transmission. Instead, the authors rely on circumstantial associations between the region from which the sequence was identified and time frame of sequence collection in countries where molnupiravir is available to draw their conclusions,” the company said.

The Food and Drug Administration authorized the use of molnupiravir for the treatment of mild to moderate COVID-19 in adults in December 2021. The FDA has also authorized the use of nirmatrelvir/ritonavir (Paxlovid), an antiviral made by Pfizer.

A version of this article appeared on WebMD.com.

This patient had a posttraumatic tache noir (also known as talon noir on the volar aspect of the feet); it is a subcorneal hematoma. The diagnosis is made clinically. Dermoscopic evaluation of tache/talon noir will reveal “pebbles on a ridge” or “satellite globules.” Confirmation of tache/talon noir can be made by paring the corneum with a #15 blade, which will reveal blood in the shavings and punctate lesions.¹

This patient noted that the knob of his baseball bat rubbed the hypothenar eminence of his nondominant hand when he took a swing. The sheer force of the knob led to the subcorneal hematoma. Tache noir was high on the differential due to his physician’s clinical experience with similar cases. Tache noir occurs predominantly in people ages 12 to 24 years, without regard to gender.² The condition is commonly found in athletes who participate in baseball, cricket, racquet sports, weightlifting, and rock climbing.^2-4

Talon noir occurs most commonly in athletes who are frequently jumping, turning, and pivoting, as in football, basketball, tennis, and lacrosse.

Tache noir can be differentiated from other conditions by the presence of preserved architecture of the skin surface and punctate capillaries beneath the stratum corneum. The differential diagnosis includes verruca vulgaris, acral melanoma, and a traumatic tattoo.

Talon/tache noir are benign conditions that do not require treatment and do not affect sports performance. The lesion will usually self-resolve within a matter of weeks from onset or can even be gently scraped with a sterile needle or blade.

This patient was advised that the lesion would resolve on its own. His knee pain was determined to be a simple case of patellofemoral syndrome or “runner’s knee” and he opted to complete a home exercise program to obtain relief.

‌

This case was adapted from: Warden D. Hyperpigmented lesion on left palm. J Fam Pract. 2021;70:459-460. Photos courtesy of Daniel Warden, MD

This patient had a posttraumatic tache noir (also known as talon noir on the volar aspect of the feet); it is a subcorneal hematoma. The diagnosis is made clinically. Dermoscopic evaluation of tache/talon noir will reveal “pebbles on a ridge” or “satellite globules.” Confirmation of tache/talon noir can be made by paring the corneum with a #15 blade, which will reveal blood in the shavings and punctate lesions.¹

This patient noted that the knob of his baseball bat rubbed the hypothenar eminence of his nondominant hand when he took a swing. The sheer force of the knob led to the subcorneal hematoma. Tache noir was high on the differential due to his physician’s clinical experience with similar cases. Tache noir occurs predominantly in people ages 12 to 24 years, without regard to gender.² The condition is commonly found in athletes who participate in baseball, cricket, racquet sports, weightlifting, and rock climbing.^2-4

Talon noir occurs most commonly in athletes who are frequently jumping, turning, and pivoting, as in football, basketball, tennis, and lacrosse.

Tache noir can be differentiated from other conditions by the presence of preserved architecture of the skin surface and punctate capillaries beneath the stratum corneum. The differential diagnosis includes verruca vulgaris, acral melanoma, and a traumatic tattoo.

Talon/tache noir are benign conditions that do not require treatment and do not affect sports performance. The lesion will usually self-resolve within a matter of weeks from onset or can even be gently scraped with a sterile needle or blade.

This patient was advised that the lesion would resolve on its own. His knee pain was determined to be a simple case of patellofemoral syndrome or “runner’s knee” and he opted to complete a home exercise program to obtain relief.

‌

This case was adapted from: Warden D. Hyperpigmented lesion on left palm. J Fam Pract. 2021;70:459-460. Photos courtesy of Daniel Warden, MD

This patient had a posttraumatic tache noir (also known as talon noir on the volar aspect of the feet); it is a subcorneal hematoma. The diagnosis is made clinically. Dermoscopic evaluation of tache/talon noir will reveal “pebbles on a ridge” or “satellite globules.” Confirmation of tache/talon noir can be made by paring the corneum with a #15 blade, which will reveal blood in the shavings and punctate lesions.¹

This patient noted that the knob of his baseball bat rubbed the hypothenar eminence of his nondominant hand when he took a swing. The sheer force of the knob led to the subcorneal hematoma. Tache noir was high on the differential due to his physician’s clinical experience with similar cases. Tache noir occurs predominantly in people ages 12 to 24 years, without regard to gender.² The condition is commonly found in athletes who participate in baseball, cricket, racquet sports, weightlifting, and rock climbing.^2-4

Talon noir occurs most commonly in athletes who are frequently jumping, turning, and pivoting, as in football, basketball, tennis, and lacrosse.

Tache noir can be differentiated from other conditions by the presence of preserved architecture of the skin surface and punctate capillaries beneath the stratum corneum. The differential diagnosis includes verruca vulgaris, acral melanoma, and a traumatic tattoo.

Talon/tache noir are benign conditions that do not require treatment and do not affect sports performance. The lesion will usually self-resolve within a matter of weeks from onset or can even be gently scraped with a sterile needle or blade.

This patient was advised that the lesion would resolve on its own. His knee pain was determined to be a simple case of patellofemoral syndrome or “runner’s knee” and he opted to complete a home exercise program to obtain relief.

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This case was adapted from: Warden D. Hyperpigmented lesion on left palm. J Fam Pract. 2021;70:459-460. Photos courtesy of Daniel Warden, MD