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FDA OKs new drug for Fabry disease
Fabry disease is a rare inherited X-linked lysosomal disorder caused by a deficiency of the enzyme alpha-galactosidase A (GLA), which leads to the buildup of globotriaosylceramide (GL-3) in blood vessels, kidneys, the heart, nerves, and other organs, increasing the risk for kidney failure, myocardial infarction, stroke, and other problems.
Elfabrio delivers a functional version of GLA. It’s given by intravenous infusion every 2 weeks.
Evidence for safety, tolerability, and efficacy of Elfabrio stems from a comprehensive clinical program in more than 140 patients with up to 7.5 years of follow up treatment.
It has been studied in both ERT-naïve and ERT-experienced patients. In one head-to-head trial, Elfabrio was non-inferior in safety and efficacy to agalsidase beta (Fabrazyme, Sanofi Genzyme), the companies said in a press statement announcing approval.
“The totality of clinical data suggests that Elfabrio has the potential to be a long-lasting therapy,” Dror Bashan, president and CEO of Protalix, said in the statement.
Patients treated with Elfabrio have experienced hypersensitivity reactions, including anaphylaxis. In clinical trials, 20 (14%) patients treated with Elfabrio experienced hypersensitivity reactions; 4 patients (3%) experienced anaphylaxis reactions that occurred within 5-40 minutes of the start of the initial infusion.
Before administering Elfabrio, pretreatment with antihistamines, antipyretics, and/or corticosteroids should be considered, the label advises.
Patients and caregivers should be informed of the signs and symptoms of hypersensitivity reactions and infusion-associated reactions and instructed to seek medical care immediately if such symptoms occur.
A case of membranoproliferative glomerulonephritis with immune depositions in the kidney was reported during clinical trials. Monitoring serum creatinine and urinary protein-to-creatinine ratio is advised. If glomerulonephritis is suspected, treatment should be stopped until a diagnostic evaluation can be conducted.
Full prescribing information is available online.
A version of this article first appeared on Medscape.com.
Fabry disease is a rare inherited X-linked lysosomal disorder caused by a deficiency of the enzyme alpha-galactosidase A (GLA), which leads to the buildup of globotriaosylceramide (GL-3) in blood vessels, kidneys, the heart, nerves, and other organs, increasing the risk for kidney failure, myocardial infarction, stroke, and other problems.
Elfabrio delivers a functional version of GLA. It’s given by intravenous infusion every 2 weeks.
Evidence for safety, tolerability, and efficacy of Elfabrio stems from a comprehensive clinical program in more than 140 patients with up to 7.5 years of follow up treatment.
It has been studied in both ERT-naïve and ERT-experienced patients. In one head-to-head trial, Elfabrio was non-inferior in safety and efficacy to agalsidase beta (Fabrazyme, Sanofi Genzyme), the companies said in a press statement announcing approval.
“The totality of clinical data suggests that Elfabrio has the potential to be a long-lasting therapy,” Dror Bashan, president and CEO of Protalix, said in the statement.
Patients treated with Elfabrio have experienced hypersensitivity reactions, including anaphylaxis. In clinical trials, 20 (14%) patients treated with Elfabrio experienced hypersensitivity reactions; 4 patients (3%) experienced anaphylaxis reactions that occurred within 5-40 minutes of the start of the initial infusion.
Before administering Elfabrio, pretreatment with antihistamines, antipyretics, and/or corticosteroids should be considered, the label advises.
Patients and caregivers should be informed of the signs and symptoms of hypersensitivity reactions and infusion-associated reactions and instructed to seek medical care immediately if such symptoms occur.
A case of membranoproliferative glomerulonephritis with immune depositions in the kidney was reported during clinical trials. Monitoring serum creatinine and urinary protein-to-creatinine ratio is advised. If glomerulonephritis is suspected, treatment should be stopped until a diagnostic evaluation can be conducted.
Full prescribing information is available online.
A version of this article first appeared on Medscape.com.
Fabry disease is a rare inherited X-linked lysosomal disorder caused by a deficiency of the enzyme alpha-galactosidase A (GLA), which leads to the buildup of globotriaosylceramide (GL-3) in blood vessels, kidneys, the heart, nerves, and other organs, increasing the risk for kidney failure, myocardial infarction, stroke, and other problems.
Elfabrio delivers a functional version of GLA. It’s given by intravenous infusion every 2 weeks.
Evidence for safety, tolerability, and efficacy of Elfabrio stems from a comprehensive clinical program in more than 140 patients with up to 7.5 years of follow up treatment.
It has been studied in both ERT-naïve and ERT-experienced patients. In one head-to-head trial, Elfabrio was non-inferior in safety and efficacy to agalsidase beta (Fabrazyme, Sanofi Genzyme), the companies said in a press statement announcing approval.
“The totality of clinical data suggests that Elfabrio has the potential to be a long-lasting therapy,” Dror Bashan, president and CEO of Protalix, said in the statement.
Patients treated with Elfabrio have experienced hypersensitivity reactions, including anaphylaxis. In clinical trials, 20 (14%) patients treated with Elfabrio experienced hypersensitivity reactions; 4 patients (3%) experienced anaphylaxis reactions that occurred within 5-40 minutes of the start of the initial infusion.
Before administering Elfabrio, pretreatment with antihistamines, antipyretics, and/or corticosteroids should be considered, the label advises.
Patients and caregivers should be informed of the signs and symptoms of hypersensitivity reactions and infusion-associated reactions and instructed to seek medical care immediately if such symptoms occur.
A case of membranoproliferative glomerulonephritis with immune depositions in the kidney was reported during clinical trials. Monitoring serum creatinine and urinary protein-to-creatinine ratio is advised. If glomerulonephritis is suspected, treatment should be stopped until a diagnostic evaluation can be conducted.
Full prescribing information is available online.
A version of this article first appeared on Medscape.com.
FDA approves first drug to treat Alzheimer’s agitation
(AD), making it the first FDA-approved drug for this indication.
“Agitation is one of the most common and challenging aspects of care among patients with dementia due to Alzheimer’s disease,” Tiffany Farchione, MD, director of the division of psychiatry in the FDA’s Center for Drug Evaluation and Research, said in a news release.
Agitation can include symptoms that range from pacing or restlessness to verbal and physical aggression. “These symptoms are leading causes of assisted living or nursing home placement and have been associated with accelerated disease progression,” Dr. Farchione said.
Brexpiprazole was approved by the FDA in 2015 as an adjunctive therapy to antidepressants for adults with major depressive disorder and for adults with schizophrenia.
Approval of the supplemental application for brexpiprazole for agitation associated with AD dementia was based on results of two randomized, double-blind, placebo-controlled studies.
In both studies, patients who received 2 mg or 3 mg of brexpiprazole showed statistically significant and clinically meaningful improvements in agitation symptoms, as shown by total Cohen-Mansfield Agitation Inventory (CMAI) score, compared with patients who received placebo.
The recommended starting dosage for the treatment of agitation associated with AD dementia is 0.5 mg once daily on days 1-7; it was increased to 1 mg once daily on days 8-14 and then to the recommended target dose of 2 mg once daily.
The dosage can be increased to the maximum recommended daily dosage of 3 mg once daily after at least 14 days, depending on clinical response and tolerability.
The most common side effects of brexpiprazole in patients with agitation associated with AD dementia include headache, dizziness, urinary tract infection, nasopharyngitis, and sleep disturbances.
The drug includes a boxed warning for medications in this class that elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.
The supplemental application for brexpiprazole for agitation had fast-track designation.
A version of this article first appeared on Medscape.com.
(AD), making it the first FDA-approved drug for this indication.
“Agitation is one of the most common and challenging aspects of care among patients with dementia due to Alzheimer’s disease,” Tiffany Farchione, MD, director of the division of psychiatry in the FDA’s Center for Drug Evaluation and Research, said in a news release.
Agitation can include symptoms that range from pacing or restlessness to verbal and physical aggression. “These symptoms are leading causes of assisted living or nursing home placement and have been associated with accelerated disease progression,” Dr. Farchione said.
Brexpiprazole was approved by the FDA in 2015 as an adjunctive therapy to antidepressants for adults with major depressive disorder and for adults with schizophrenia.
Approval of the supplemental application for brexpiprazole for agitation associated with AD dementia was based on results of two randomized, double-blind, placebo-controlled studies.
In both studies, patients who received 2 mg or 3 mg of brexpiprazole showed statistically significant and clinically meaningful improvements in agitation symptoms, as shown by total Cohen-Mansfield Agitation Inventory (CMAI) score, compared with patients who received placebo.
The recommended starting dosage for the treatment of agitation associated with AD dementia is 0.5 mg once daily on days 1-7; it was increased to 1 mg once daily on days 8-14 and then to the recommended target dose of 2 mg once daily.
The dosage can be increased to the maximum recommended daily dosage of 3 mg once daily after at least 14 days, depending on clinical response and tolerability.
The most common side effects of brexpiprazole in patients with agitation associated with AD dementia include headache, dizziness, urinary tract infection, nasopharyngitis, and sleep disturbances.
The drug includes a boxed warning for medications in this class that elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.
The supplemental application for brexpiprazole for agitation had fast-track designation.
A version of this article first appeared on Medscape.com.
(AD), making it the first FDA-approved drug for this indication.
“Agitation is one of the most common and challenging aspects of care among patients with dementia due to Alzheimer’s disease,” Tiffany Farchione, MD, director of the division of psychiatry in the FDA’s Center for Drug Evaluation and Research, said in a news release.
Agitation can include symptoms that range from pacing or restlessness to verbal and physical aggression. “These symptoms are leading causes of assisted living or nursing home placement and have been associated with accelerated disease progression,” Dr. Farchione said.
Brexpiprazole was approved by the FDA in 2015 as an adjunctive therapy to antidepressants for adults with major depressive disorder and for adults with schizophrenia.
Approval of the supplemental application for brexpiprazole for agitation associated with AD dementia was based on results of two randomized, double-blind, placebo-controlled studies.
In both studies, patients who received 2 mg or 3 mg of brexpiprazole showed statistically significant and clinically meaningful improvements in agitation symptoms, as shown by total Cohen-Mansfield Agitation Inventory (CMAI) score, compared with patients who received placebo.
The recommended starting dosage for the treatment of agitation associated with AD dementia is 0.5 mg once daily on days 1-7; it was increased to 1 mg once daily on days 8-14 and then to the recommended target dose of 2 mg once daily.
The dosage can be increased to the maximum recommended daily dosage of 3 mg once daily after at least 14 days, depending on clinical response and tolerability.
The most common side effects of brexpiprazole in patients with agitation associated with AD dementia include headache, dizziness, urinary tract infection, nasopharyngitis, and sleep disturbances.
The drug includes a boxed warning for medications in this class that elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.
The supplemental application for brexpiprazole for agitation had fast-track designation.
A version of this article first appeared on Medscape.com.
Medical students gain momentum in effort to ban legacy admissions
, which they say offer preferential treatment to applicants based on their association with donors or alumni.
While an estimated 25% of public colleges and universities still use legacy admissions, a growing list of top medical schools have moved away from the practice over the last decade, including Johns Hopkins University, Baltimore, and Tufts University, Medford, Mass.
Legacy admissions contradict schools’ more inclusive policies, Senila Yasmin, MPH, a second-year medical student at Tufts University, said in an interview. While Tufts maintains legacy admissions for its undergraduate applicants, the medical school stopped the practice in 2021, said Ms. Yasmin, a member of a student group that lobbied against the school’s legacy preferences.
Describing herself as a low-income, first-generation Muslim-Pakistani American, Ms. Yasmin wants to use her experience at Tufts to improve accessibility for students like herself.
As a member of the American Medical Association (AMA) Medical Student Section, she coauthored a resolution stating that legacy admissions go against the AMA’s strategic plan to advance racial justice and health equity. The Student Section passed the resolution in November, and in June, the AMA House of Delegates will vote on whether to adopt the policy.
Along with a Supreme Court decision that could strike down race-conscious college admissions, an AMA policy could convince medical schools to rethink legacy admissions and how to maintain diverse student bodies. In June, the court is expected to issue a decision in the Students for Fair Admissions lawsuit against Harvard University, Cambridge, Mass., and the University of North Carolina, Chapel Hill, which alleges that considering race in holistic admissions constitutes racial discrimination and violates the Equal Protection Clause.
Opponents of legacy admissions, like Ms. Yasmin, say it penalizes students from racial minorities and lower socioeconomic backgrounds, hampering a fair and equitable admissions process that attracts diverse medical school admissions.
Diversity of medical applicants
Diversity in medical schools continued to increase last year with more Black, Hispanic, and female students applying and enrolling, according to a recent report by the Association of American Medical Colleges (AAMC). However, universities often include nonacademic criteria in their admission assessments to improve educational access for underrepresented minorities.
Medical schools carefully consider each applicant’s background “to yield a diverse class of students,” Geoffrey Young, PhD, AAMC’s senior director of transforming the health care workforce, told this news organization.
Some schools, such as Morehouse School of Medicine, Atlanta, the University of Virginia School of Medicine, Charlottesville, and the University of Arizona College of Medicine, Tucson, perform a thorough review of candidates while offering admissions practices designed specifically for legacy applicants. The schools assert that legacy designation doesn’t factor into the student’s likelihood of acceptance.
The arrangement may show that schools want to commit to equity and fairness but have trouble moving away from entrenched traditions, two professors from Penn State College of Medicine, Hershey, Pa., who sit on separate medical admissions subcommittees, wrote last year in Bioethics Today.
Legislation may hasten legacies’ end
In December, Ms. Yasmin and a group of Massachusetts Medical Society student-members presented another resolution to the state medical society, which adopted it.
The society’s new policy opposes the use of legacy status in medical school admissions and supports mechanisms to eliminate its inclusion from the application process, Theodore Calianos II, MD, FACS, president of the Massachusetts Medical Society, said in an interview.
“Legacy preferences limit racial and socioeconomic diversity on campuses, so we asked, ‘What can we do so that everyone has equal access to medical education?’ It is exciting to see the students and young physicians – the future of medicine – become involved in policymaking.”
Proposed laws may also hasten the end of legacy admissions. Last year, the U.S. Senate began considering a bill prohibiting colleges receiving federal financial aid from giving preferential treatment to students based on their relations to donors or alumni. However, the bill allows the Department of Education to make exceptions for institutions serving historically underrepresented groups.
The New York State Senate and the New York State Assembly also are reviewing bills that ban legacy and early admissions policies at public and private universities. Connecticut announced similar legislation last year. Massachusetts legislators are considering two bills: one that would ban the practice at the state’s public universities and another that would require all schools using legacy status to pay a “public service fee” equal to a percentage of its endowment. Colleges with endowment assets exceeding $2 billion must pay at least $2 million, according to the bill’s text.
At schools like Harvard, whose endowment surpasses $50 billion, the option to pay the penalty will make the law moot, Michael Walls, DO, MPH, president of the American Medical Student Association (AMSA), said in an interview. “Smaller schools wouldn’t be able to afford the fine and are less likely to be doing [legacy admissions] anyway,” he said. “The schools that want to continue doing it could just pay the fine.”
Dr. Walls said AMSA supports race-conscious admissions processes and anything that increases fairness for medical school applicants. “Whatever [fair] means is up for interpretation, but it would be great to eliminate legacy admissions,” he said.
A version of this article originally appeared on Medscape.com.
, which they say offer preferential treatment to applicants based on their association with donors or alumni.
While an estimated 25% of public colleges and universities still use legacy admissions, a growing list of top medical schools have moved away from the practice over the last decade, including Johns Hopkins University, Baltimore, and Tufts University, Medford, Mass.
Legacy admissions contradict schools’ more inclusive policies, Senila Yasmin, MPH, a second-year medical student at Tufts University, said in an interview. While Tufts maintains legacy admissions for its undergraduate applicants, the medical school stopped the practice in 2021, said Ms. Yasmin, a member of a student group that lobbied against the school’s legacy preferences.
Describing herself as a low-income, first-generation Muslim-Pakistani American, Ms. Yasmin wants to use her experience at Tufts to improve accessibility for students like herself.
As a member of the American Medical Association (AMA) Medical Student Section, she coauthored a resolution stating that legacy admissions go against the AMA’s strategic plan to advance racial justice and health equity. The Student Section passed the resolution in November, and in June, the AMA House of Delegates will vote on whether to adopt the policy.
Along with a Supreme Court decision that could strike down race-conscious college admissions, an AMA policy could convince medical schools to rethink legacy admissions and how to maintain diverse student bodies. In June, the court is expected to issue a decision in the Students for Fair Admissions lawsuit against Harvard University, Cambridge, Mass., and the University of North Carolina, Chapel Hill, which alleges that considering race in holistic admissions constitutes racial discrimination and violates the Equal Protection Clause.
Opponents of legacy admissions, like Ms. Yasmin, say it penalizes students from racial minorities and lower socioeconomic backgrounds, hampering a fair and equitable admissions process that attracts diverse medical school admissions.
Diversity of medical applicants
Diversity in medical schools continued to increase last year with more Black, Hispanic, and female students applying and enrolling, according to a recent report by the Association of American Medical Colleges (AAMC). However, universities often include nonacademic criteria in their admission assessments to improve educational access for underrepresented minorities.
Medical schools carefully consider each applicant’s background “to yield a diverse class of students,” Geoffrey Young, PhD, AAMC’s senior director of transforming the health care workforce, told this news organization.
Some schools, such as Morehouse School of Medicine, Atlanta, the University of Virginia School of Medicine, Charlottesville, and the University of Arizona College of Medicine, Tucson, perform a thorough review of candidates while offering admissions practices designed specifically for legacy applicants. The schools assert that legacy designation doesn’t factor into the student’s likelihood of acceptance.
The arrangement may show that schools want to commit to equity and fairness but have trouble moving away from entrenched traditions, two professors from Penn State College of Medicine, Hershey, Pa., who sit on separate medical admissions subcommittees, wrote last year in Bioethics Today.
Legislation may hasten legacies’ end
In December, Ms. Yasmin and a group of Massachusetts Medical Society student-members presented another resolution to the state medical society, which adopted it.
The society’s new policy opposes the use of legacy status in medical school admissions and supports mechanisms to eliminate its inclusion from the application process, Theodore Calianos II, MD, FACS, president of the Massachusetts Medical Society, said in an interview.
“Legacy preferences limit racial and socioeconomic diversity on campuses, so we asked, ‘What can we do so that everyone has equal access to medical education?’ It is exciting to see the students and young physicians – the future of medicine – become involved in policymaking.”
Proposed laws may also hasten the end of legacy admissions. Last year, the U.S. Senate began considering a bill prohibiting colleges receiving federal financial aid from giving preferential treatment to students based on their relations to donors or alumni. However, the bill allows the Department of Education to make exceptions for institutions serving historically underrepresented groups.
The New York State Senate and the New York State Assembly also are reviewing bills that ban legacy and early admissions policies at public and private universities. Connecticut announced similar legislation last year. Massachusetts legislators are considering two bills: one that would ban the practice at the state’s public universities and another that would require all schools using legacy status to pay a “public service fee” equal to a percentage of its endowment. Colleges with endowment assets exceeding $2 billion must pay at least $2 million, according to the bill’s text.
At schools like Harvard, whose endowment surpasses $50 billion, the option to pay the penalty will make the law moot, Michael Walls, DO, MPH, president of the American Medical Student Association (AMSA), said in an interview. “Smaller schools wouldn’t be able to afford the fine and are less likely to be doing [legacy admissions] anyway,” he said. “The schools that want to continue doing it could just pay the fine.”
Dr. Walls said AMSA supports race-conscious admissions processes and anything that increases fairness for medical school applicants. “Whatever [fair] means is up for interpretation, but it would be great to eliminate legacy admissions,” he said.
A version of this article originally appeared on Medscape.com.
, which they say offer preferential treatment to applicants based on their association with donors or alumni.
While an estimated 25% of public colleges and universities still use legacy admissions, a growing list of top medical schools have moved away from the practice over the last decade, including Johns Hopkins University, Baltimore, and Tufts University, Medford, Mass.
Legacy admissions contradict schools’ more inclusive policies, Senila Yasmin, MPH, a second-year medical student at Tufts University, said in an interview. While Tufts maintains legacy admissions for its undergraduate applicants, the medical school stopped the practice in 2021, said Ms. Yasmin, a member of a student group that lobbied against the school’s legacy preferences.
Describing herself as a low-income, first-generation Muslim-Pakistani American, Ms. Yasmin wants to use her experience at Tufts to improve accessibility for students like herself.
As a member of the American Medical Association (AMA) Medical Student Section, she coauthored a resolution stating that legacy admissions go against the AMA’s strategic plan to advance racial justice and health equity. The Student Section passed the resolution in November, and in June, the AMA House of Delegates will vote on whether to adopt the policy.
Along with a Supreme Court decision that could strike down race-conscious college admissions, an AMA policy could convince medical schools to rethink legacy admissions and how to maintain diverse student bodies. In June, the court is expected to issue a decision in the Students for Fair Admissions lawsuit against Harvard University, Cambridge, Mass., and the University of North Carolina, Chapel Hill, which alleges that considering race in holistic admissions constitutes racial discrimination and violates the Equal Protection Clause.
Opponents of legacy admissions, like Ms. Yasmin, say it penalizes students from racial minorities and lower socioeconomic backgrounds, hampering a fair and equitable admissions process that attracts diverse medical school admissions.
Diversity of medical applicants
Diversity in medical schools continued to increase last year with more Black, Hispanic, and female students applying and enrolling, according to a recent report by the Association of American Medical Colleges (AAMC). However, universities often include nonacademic criteria in their admission assessments to improve educational access for underrepresented minorities.
Medical schools carefully consider each applicant’s background “to yield a diverse class of students,” Geoffrey Young, PhD, AAMC’s senior director of transforming the health care workforce, told this news organization.
Some schools, such as Morehouse School of Medicine, Atlanta, the University of Virginia School of Medicine, Charlottesville, and the University of Arizona College of Medicine, Tucson, perform a thorough review of candidates while offering admissions practices designed specifically for legacy applicants. The schools assert that legacy designation doesn’t factor into the student’s likelihood of acceptance.
The arrangement may show that schools want to commit to equity and fairness but have trouble moving away from entrenched traditions, two professors from Penn State College of Medicine, Hershey, Pa., who sit on separate medical admissions subcommittees, wrote last year in Bioethics Today.
Legislation may hasten legacies’ end
In December, Ms. Yasmin and a group of Massachusetts Medical Society student-members presented another resolution to the state medical society, which adopted it.
The society’s new policy opposes the use of legacy status in medical school admissions and supports mechanisms to eliminate its inclusion from the application process, Theodore Calianos II, MD, FACS, president of the Massachusetts Medical Society, said in an interview.
“Legacy preferences limit racial and socioeconomic diversity on campuses, so we asked, ‘What can we do so that everyone has equal access to medical education?’ It is exciting to see the students and young physicians – the future of medicine – become involved in policymaking.”
Proposed laws may also hasten the end of legacy admissions. Last year, the U.S. Senate began considering a bill prohibiting colleges receiving federal financial aid from giving preferential treatment to students based on their relations to donors or alumni. However, the bill allows the Department of Education to make exceptions for institutions serving historically underrepresented groups.
The New York State Senate and the New York State Assembly also are reviewing bills that ban legacy and early admissions policies at public and private universities. Connecticut announced similar legislation last year. Massachusetts legislators are considering two bills: one that would ban the practice at the state’s public universities and another that would require all schools using legacy status to pay a “public service fee” equal to a percentage of its endowment. Colleges with endowment assets exceeding $2 billion must pay at least $2 million, according to the bill’s text.
At schools like Harvard, whose endowment surpasses $50 billion, the option to pay the penalty will make the law moot, Michael Walls, DO, MPH, president of the American Medical Student Association (AMSA), said in an interview. “Smaller schools wouldn’t be able to afford the fine and are less likely to be doing [legacy admissions] anyway,” he said. “The schools that want to continue doing it could just pay the fine.”
Dr. Walls said AMSA supports race-conscious admissions processes and anything that increases fairness for medical school applicants. “Whatever [fair] means is up for interpretation, but it would be great to eliminate legacy admissions,” he said.
A version of this article originally appeared on Medscape.com.
New protocol could cut fasting period to detect insulinomas
SEATTLE – , therefore yielding significant hospital cost savings, new data suggest.
Insulinomas are small, rare types of pancreatic tumors that are benign but secrete excess insulin, leading to hypoglycemia. More than 99% of people with insulinomas develop hypoglycemia within 72 hours, hence, the use of a 72-hour fast to detect these tumors.
But most people who are evaluated for hypoglycemia do not have an insulinoma and fasting in hospital for 3 days is burdensome and costly.
As part of a quality improvement project, Cleveland Clinic endocrinology fellow Michelle D. Lundholm, MD, and colleagues modified their hospital’s protocol to include measurement of beta-hydroxybutyrate (BHB), a marker of insulin suppression, every 12 hours with a cutoff of ≥ 2.7mmol/L for stopping the fast if hypoglycemia (venous glucose ≤ 45mg/dL) hasn’t occurred. This intervention cut in half the number of patients who needed to fast for the full 72 hours, without missing any insulinomas.
“We are excited to share how a relatively simple adjustment to our protocol allowed us to successfully reduce the burden of fasting on patients and more effectively utilize hospital resources. We hope that this encourages other centers to consider doing the same,” Dr. Lundholm said in an interview.
“These data support a 48-hour fast. The literature supports that’s sufficient to detect 95% of insulinomas. ... But, given our small insulinoma cohort, we are looking forward to learning from other studies,” she added.
Dr. Lundholm presented the late-breaking oral abstract at the annual scientific & clinical congress of the American Association of Clinical Endocrinology.
Asked to comment, session moderator Jenna Sarvaideo, MD, said: “We’re often steeped in tradition. That’s why this abstract and this quality improvement project is so exciting to me because it challenges the history. … and I think it’s ultimately helping patients.”
Dr. Sarvaideo, of Clement J. Zablocki VA Medical Center, Milwaukee, noted that, typically, although the fast will be stopped before 72 hours if the patient develops hypoglycemia, “often they don’t, so we keep going on and on. If we just paid more attention to the beta-hydroxybutyrate, I think that would be practice changing.”
She added that more data would be optimal, given that there were under 100 patients in the study, “but I do think that devising protocols is … very much still at the hands of the endocrinologists. I think that this work could make groups reevaluate their protocol and change it, maybe even with a small dataset and then move on from there and see what they see.”
Indeed, Dr. Lundholm pointed out that some institutions, such as the Mayo Clinic, already include 6-hour BHB measurements (along with glucose and insulin) in their protocols.
“For any institution that already draws regular BHB levels like this, it would be very easy to implement a new stopping criterion without adding any additional costs,” she said in an interview.
All insulinomas became apparent in less than 48 hours
The first report to look at the value of testing BHB at regular intervals was published by the Mayo Clinic in 2005 after they noticed patients without insulinoma were complaining of ketosis symptoms such as foul breath and digestive problems toward the end of the fast.
However, although BHB testing is used today as part of the evaluation, it’s typically only drawn at the start of the protocol and again at the time of hypoglycemia or at the end of 72 hours because more frequent values hadn’t been thought to be useful for guiding clinical management, Dr. Lundholm explained.
Between January 2018 and June 2020, Dr. Lundholm and colleagues followed 34 Cleveland Clinic patients who completed the usual 72-hour fast protocol. Overall, 71% were female, and 26% had undergone prior bariatric surgery procedures. Eleven (32%) developed hypoglycemia and stopped fasting. The other 23 (68%) fasted for the full 72 hours.
Dr. Lundholm and colleagues determined that the fast could have ended earlier in 35% of patients based on an elevated BHB without missing any insulinomas.
And so, in June 2020 the group revised their protocol to include the BHB ≥ 2.7mmol/L stopping criterion. Of the 30 patients evaluated from June 2020 to January 2023, 87% were female and 17% had undergone a bariatric procedure.
Here, 15 (50%) reached a BHB ≥ 2.7mmol/L and ended their fast at an average of 43.8 hours. Another seven (23%) ended the fast after developing hypoglycemia. Just eight patients (27%) fasted for the full 72 hours.
Overall, this resulted in approximately 376 fewer cumulative hours of inpatient admission than if patients had fasted for the full time.
Of the 64 patients who have completed the fasting protocol since 2018, seven (11%) who did have an insulinoma developed hypoglycemia within 48 hours and with a BHB < 2.7 mmol/L (median, 0.15).
Advantages: cost, adherence
A day in a general medicine bed at Cleveland Clinic was quoted as costing $2,420, based on publicly available information as of Jan. 1, 2023. “If half of patients leave 1 day earlier, this equates to about $1,210 per patient in savings from bed costs alone,” Dr. Lundholm told this news organization.
The revised protocol required an additional two to four blood draws, depending on the length of the fast. “The cost of these extra blood tests varies by lab and by count, but even at its highest does not exceed the amount of savings from bed costs,” she noted.
Patient adherence is another potential benefit of the revised protocol.
“Any study that requires 72 hours of patient cooperation is a challenge, particularly in an uncomfortable position like fasting. When we looked at these adherence numbers, we found that the percentage of patients who prematurely ended their fast decreased from 35% to 17% with the updated protocol,” Dr. Lundholm continued.
“This translates to fewer inconclusive results and fewer readmissions for repeat 72-hour fasting. While this was not our primary outcome, it was another noted benefit of our change,” she said.
Dr. Lundholm and Dr. Sarvaideo have reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
SEATTLE – , therefore yielding significant hospital cost savings, new data suggest.
Insulinomas are small, rare types of pancreatic tumors that are benign but secrete excess insulin, leading to hypoglycemia. More than 99% of people with insulinomas develop hypoglycemia within 72 hours, hence, the use of a 72-hour fast to detect these tumors.
But most people who are evaluated for hypoglycemia do not have an insulinoma and fasting in hospital for 3 days is burdensome and costly.
As part of a quality improvement project, Cleveland Clinic endocrinology fellow Michelle D. Lundholm, MD, and colleagues modified their hospital’s protocol to include measurement of beta-hydroxybutyrate (BHB), a marker of insulin suppression, every 12 hours with a cutoff of ≥ 2.7mmol/L for stopping the fast if hypoglycemia (venous glucose ≤ 45mg/dL) hasn’t occurred. This intervention cut in half the number of patients who needed to fast for the full 72 hours, without missing any insulinomas.
“We are excited to share how a relatively simple adjustment to our protocol allowed us to successfully reduce the burden of fasting on patients and more effectively utilize hospital resources. We hope that this encourages other centers to consider doing the same,” Dr. Lundholm said in an interview.
“These data support a 48-hour fast. The literature supports that’s sufficient to detect 95% of insulinomas. ... But, given our small insulinoma cohort, we are looking forward to learning from other studies,” she added.
Dr. Lundholm presented the late-breaking oral abstract at the annual scientific & clinical congress of the American Association of Clinical Endocrinology.
Asked to comment, session moderator Jenna Sarvaideo, MD, said: “We’re often steeped in tradition. That’s why this abstract and this quality improvement project is so exciting to me because it challenges the history. … and I think it’s ultimately helping patients.”
Dr. Sarvaideo, of Clement J. Zablocki VA Medical Center, Milwaukee, noted that, typically, although the fast will be stopped before 72 hours if the patient develops hypoglycemia, “often they don’t, so we keep going on and on. If we just paid more attention to the beta-hydroxybutyrate, I think that would be practice changing.”
She added that more data would be optimal, given that there were under 100 patients in the study, “but I do think that devising protocols is … very much still at the hands of the endocrinologists. I think that this work could make groups reevaluate their protocol and change it, maybe even with a small dataset and then move on from there and see what they see.”
Indeed, Dr. Lundholm pointed out that some institutions, such as the Mayo Clinic, already include 6-hour BHB measurements (along with glucose and insulin) in their protocols.
“For any institution that already draws regular BHB levels like this, it would be very easy to implement a new stopping criterion without adding any additional costs,” she said in an interview.
All insulinomas became apparent in less than 48 hours
The first report to look at the value of testing BHB at regular intervals was published by the Mayo Clinic in 2005 after they noticed patients without insulinoma were complaining of ketosis symptoms such as foul breath and digestive problems toward the end of the fast.
However, although BHB testing is used today as part of the evaluation, it’s typically only drawn at the start of the protocol and again at the time of hypoglycemia or at the end of 72 hours because more frequent values hadn’t been thought to be useful for guiding clinical management, Dr. Lundholm explained.
Between January 2018 and June 2020, Dr. Lundholm and colleagues followed 34 Cleveland Clinic patients who completed the usual 72-hour fast protocol. Overall, 71% were female, and 26% had undergone prior bariatric surgery procedures. Eleven (32%) developed hypoglycemia and stopped fasting. The other 23 (68%) fasted for the full 72 hours.
Dr. Lundholm and colleagues determined that the fast could have ended earlier in 35% of patients based on an elevated BHB without missing any insulinomas.
And so, in June 2020 the group revised their protocol to include the BHB ≥ 2.7mmol/L stopping criterion. Of the 30 patients evaluated from June 2020 to January 2023, 87% were female and 17% had undergone a bariatric procedure.
Here, 15 (50%) reached a BHB ≥ 2.7mmol/L and ended their fast at an average of 43.8 hours. Another seven (23%) ended the fast after developing hypoglycemia. Just eight patients (27%) fasted for the full 72 hours.
Overall, this resulted in approximately 376 fewer cumulative hours of inpatient admission than if patients had fasted for the full time.
Of the 64 patients who have completed the fasting protocol since 2018, seven (11%) who did have an insulinoma developed hypoglycemia within 48 hours and with a BHB < 2.7 mmol/L (median, 0.15).
Advantages: cost, adherence
A day in a general medicine bed at Cleveland Clinic was quoted as costing $2,420, based on publicly available information as of Jan. 1, 2023. “If half of patients leave 1 day earlier, this equates to about $1,210 per patient in savings from bed costs alone,” Dr. Lundholm told this news organization.
The revised protocol required an additional two to four blood draws, depending on the length of the fast. “The cost of these extra blood tests varies by lab and by count, but even at its highest does not exceed the amount of savings from bed costs,” she noted.
Patient adherence is another potential benefit of the revised protocol.
“Any study that requires 72 hours of patient cooperation is a challenge, particularly in an uncomfortable position like fasting. When we looked at these adherence numbers, we found that the percentage of patients who prematurely ended their fast decreased from 35% to 17% with the updated protocol,” Dr. Lundholm continued.
“This translates to fewer inconclusive results and fewer readmissions for repeat 72-hour fasting. While this was not our primary outcome, it was another noted benefit of our change,” she said.
Dr. Lundholm and Dr. Sarvaideo have reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
SEATTLE – , therefore yielding significant hospital cost savings, new data suggest.
Insulinomas are small, rare types of pancreatic tumors that are benign but secrete excess insulin, leading to hypoglycemia. More than 99% of people with insulinomas develop hypoglycemia within 72 hours, hence, the use of a 72-hour fast to detect these tumors.
But most people who are evaluated for hypoglycemia do not have an insulinoma and fasting in hospital for 3 days is burdensome and costly.
As part of a quality improvement project, Cleveland Clinic endocrinology fellow Michelle D. Lundholm, MD, and colleagues modified their hospital’s protocol to include measurement of beta-hydroxybutyrate (BHB), a marker of insulin suppression, every 12 hours with a cutoff of ≥ 2.7mmol/L for stopping the fast if hypoglycemia (venous glucose ≤ 45mg/dL) hasn’t occurred. This intervention cut in half the number of patients who needed to fast for the full 72 hours, without missing any insulinomas.
“We are excited to share how a relatively simple adjustment to our protocol allowed us to successfully reduce the burden of fasting on patients and more effectively utilize hospital resources. We hope that this encourages other centers to consider doing the same,” Dr. Lundholm said in an interview.
“These data support a 48-hour fast. The literature supports that’s sufficient to detect 95% of insulinomas. ... But, given our small insulinoma cohort, we are looking forward to learning from other studies,” she added.
Dr. Lundholm presented the late-breaking oral abstract at the annual scientific & clinical congress of the American Association of Clinical Endocrinology.
Asked to comment, session moderator Jenna Sarvaideo, MD, said: “We’re often steeped in tradition. That’s why this abstract and this quality improvement project is so exciting to me because it challenges the history. … and I think it’s ultimately helping patients.”
Dr. Sarvaideo, of Clement J. Zablocki VA Medical Center, Milwaukee, noted that, typically, although the fast will be stopped before 72 hours if the patient develops hypoglycemia, “often they don’t, so we keep going on and on. If we just paid more attention to the beta-hydroxybutyrate, I think that would be practice changing.”
She added that more data would be optimal, given that there were under 100 patients in the study, “but I do think that devising protocols is … very much still at the hands of the endocrinologists. I think that this work could make groups reevaluate their protocol and change it, maybe even with a small dataset and then move on from there and see what they see.”
Indeed, Dr. Lundholm pointed out that some institutions, such as the Mayo Clinic, already include 6-hour BHB measurements (along with glucose and insulin) in their protocols.
“For any institution that already draws regular BHB levels like this, it would be very easy to implement a new stopping criterion without adding any additional costs,” she said in an interview.
All insulinomas became apparent in less than 48 hours
The first report to look at the value of testing BHB at regular intervals was published by the Mayo Clinic in 2005 after they noticed patients without insulinoma were complaining of ketosis symptoms such as foul breath and digestive problems toward the end of the fast.
However, although BHB testing is used today as part of the evaluation, it’s typically only drawn at the start of the protocol and again at the time of hypoglycemia or at the end of 72 hours because more frequent values hadn’t been thought to be useful for guiding clinical management, Dr. Lundholm explained.
Between January 2018 and June 2020, Dr. Lundholm and colleagues followed 34 Cleveland Clinic patients who completed the usual 72-hour fast protocol. Overall, 71% were female, and 26% had undergone prior bariatric surgery procedures. Eleven (32%) developed hypoglycemia and stopped fasting. The other 23 (68%) fasted for the full 72 hours.
Dr. Lundholm and colleagues determined that the fast could have ended earlier in 35% of patients based on an elevated BHB without missing any insulinomas.
And so, in June 2020 the group revised their protocol to include the BHB ≥ 2.7mmol/L stopping criterion. Of the 30 patients evaluated from June 2020 to January 2023, 87% were female and 17% had undergone a bariatric procedure.
Here, 15 (50%) reached a BHB ≥ 2.7mmol/L and ended their fast at an average of 43.8 hours. Another seven (23%) ended the fast after developing hypoglycemia. Just eight patients (27%) fasted for the full 72 hours.
Overall, this resulted in approximately 376 fewer cumulative hours of inpatient admission than if patients had fasted for the full time.
Of the 64 patients who have completed the fasting protocol since 2018, seven (11%) who did have an insulinoma developed hypoglycemia within 48 hours and with a BHB < 2.7 mmol/L (median, 0.15).
Advantages: cost, adherence
A day in a general medicine bed at Cleveland Clinic was quoted as costing $2,420, based on publicly available information as of Jan. 1, 2023. “If half of patients leave 1 day earlier, this equates to about $1,210 per patient in savings from bed costs alone,” Dr. Lundholm told this news organization.
The revised protocol required an additional two to four blood draws, depending on the length of the fast. “The cost of these extra blood tests varies by lab and by count, but even at its highest does not exceed the amount of savings from bed costs,” she noted.
Patient adherence is another potential benefit of the revised protocol.
“Any study that requires 72 hours of patient cooperation is a challenge, particularly in an uncomfortable position like fasting. When we looked at these adherence numbers, we found that the percentage of patients who prematurely ended their fast decreased from 35% to 17% with the updated protocol,” Dr. Lundholm continued.
“This translates to fewer inconclusive results and fewer readmissions for repeat 72-hour fasting. While this was not our primary outcome, it was another noted benefit of our change,” she said.
Dr. Lundholm and Dr. Sarvaideo have reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
AT AACE 2023
New USPSTF draft suggests mammography start at 40, not 50
The major change: USPSTF proposed reducing the recommended start age for routine screening mammograms from age 50 to age 40. The latest recommendation, which carries a B grade, also calls for screening every other year and sets a cutoff age of 74.
The task force’s A and B ratings indicate strong confidence in the evidence for benefit, meaning that clinicians should encourage their patients to get these services as appropriate.
The influential federal advisory panel last updated these recommendations in 2016. At the time, USPSTF recommended routine screening mammograms starting at age 50, and gave a C grade to starting before that.
In the 2016 recommendations, “we felt a woman could start screening in her 40s depending on how she feels about the harms and benefits in an individualized personal decision,” USPSTF member John Wong, MD, chief of clinical decision making and a primary care physician at Tufts Medical Center in Boston, said in an interview. “In this draft recommendation, we now recommend that all women get screened starting at age 40.”
Two major factors prompted the change, explained Dr. Wong. One is that more women are being diagnosed with breast cancer in their 40s. The other is that a growing body of evidence showing that Black women get breast cancer younger, are more likely to die of breast cancer, and would benefit from earlier screening.
“It is now clear that screening every other year starting at age 40 has the potential to save about 20% more lives among all women and there is even greater potential benefit for Black women, who are much more likely to die from breast cancer,” Dr. Wong said.
The American Cancer Society (ACS) called the draft recommendations a “significant positive change,” while noting that the task force recommendations only apply to women at average risk for breast cancer.
The American College of Radiology (ACR) already recommends yearly mammograms for average risk women starting at age 40. Its latest guidelines on mammography call for women at higher-than-average risk for breast cancer to undergo a risk assessment by age 25 to determine if screening before age 40 is needed.
When asked about the differing views, Debra Monticciolo, MD, division chief for breast imaging at Massachusetts General Hospital, said annual screenings that follow ACR recommendations would save more lives than the every-other-year approach backed by the task force. Dr. Monticciolo also highlighted that the available scientific evidence supports earlier assessment as well as augmented and earlier-than-age-40 screening of many women – particularly Black women.
“These evidence-based updates should spur more-informed doctor–patient conversations and help providers save more lives,” Dr. Monticciolo said in a press release.
Insurance access
Typically, upgrading a USPSTF recommendation from C to B leads to better access and insurance coverage for patients. The Affordable Care Act (ACA) of 2010 requires insurers to cover the cost of services that get A and B recommendations from the USPSTF without charging copays – a mandate intended to promote greater use for highly regarded services.
But Congress created a special workaround that effectively makes the ACA mandate apply to the 2002 task force recommendations on mammography. In those recommendations, the task force gave a B grade to screening mammograms every 1 or 2 years starting at age 40 without an age limit.
Federal lawmakers have sought to provide copay-free access to mammograms for this entire population even when the USPSTF recommendations in 2009 and 2016 gave a C grade to routine screening for women under 50.
Still, “it is important to note that our recommendation is based solely on the science of what works to prevent breast cancer and it is not a recommendation for or against insurance coverage,” the task force acknowledged when unveiling the new draft update. “Coverage decisions involve considerations beyond the evidence about clinical benefit, and in the end, these decisions are the responsibility of payors, regulators, and legislators.”
Uncertainties persist
The new draft recommendations also highlight the persistent gaps in knowledge about the uses of mammography, despite years of widespread use of this screening tool.
The updated draft recommendations emphasize the lack of sufficient evidence to address major areas of concern related to screening and treating Black women, older women, women with dense breasts, and those with ductal carcinoma in situ (DCIS).
The task force called for more research addressing the underlying causes of elevated breast cancer mortality rates among Black women.
The USPSTF also issued an ‘I’ statement for providing women with dense breasts additional screening with breast ultrasound or MRI and for screening women older than 75 for breast cancer. Such statements indicate that the available evidence is lacking, poor quality, or conflicting, and thus the USPSTF can’t assess the benefits and harms or make a recommendation for or against providing the preventive service.
“Nearly half of all women have dense breasts, which increases their risk for breast cancer and means that mammograms may not work as well for them. We need to know more about whether and how additional screening might help women with dense breasts stay healthy,” the task force explained.
The task force also called for more research on approaches to reduce the risk for overdiagnosis and overtreatment for breast lesions, such as DCIS, which are identified through screening.
One analysis – the COMET study – is currently underway to assess whether women could be spared surgery for DCIS and opt for watchful waiting instead.
“If we can find that monitoring them carefully, either with or without some sort of endocrine therapy, is just as effective in keeping patients free of invasive cancer as surgery, then I think we could help to de-escalate treatment for this very low-risk group of patients,” Shelley Hwang, MD, MPH, principal investigator of the COMET study, told this news organization in December.
The task force will accept comments from the public on this draft update through June 5.
A version of this article first appeared on Medscape.com.
The major change: USPSTF proposed reducing the recommended start age for routine screening mammograms from age 50 to age 40. The latest recommendation, which carries a B grade, also calls for screening every other year and sets a cutoff age of 74.
The task force’s A and B ratings indicate strong confidence in the evidence for benefit, meaning that clinicians should encourage their patients to get these services as appropriate.
The influential federal advisory panel last updated these recommendations in 2016. At the time, USPSTF recommended routine screening mammograms starting at age 50, and gave a C grade to starting before that.
In the 2016 recommendations, “we felt a woman could start screening in her 40s depending on how she feels about the harms and benefits in an individualized personal decision,” USPSTF member John Wong, MD, chief of clinical decision making and a primary care physician at Tufts Medical Center in Boston, said in an interview. “In this draft recommendation, we now recommend that all women get screened starting at age 40.”
Two major factors prompted the change, explained Dr. Wong. One is that more women are being diagnosed with breast cancer in their 40s. The other is that a growing body of evidence showing that Black women get breast cancer younger, are more likely to die of breast cancer, and would benefit from earlier screening.
“It is now clear that screening every other year starting at age 40 has the potential to save about 20% more lives among all women and there is even greater potential benefit for Black women, who are much more likely to die from breast cancer,” Dr. Wong said.
The American Cancer Society (ACS) called the draft recommendations a “significant positive change,” while noting that the task force recommendations only apply to women at average risk for breast cancer.
The American College of Radiology (ACR) already recommends yearly mammograms for average risk women starting at age 40. Its latest guidelines on mammography call for women at higher-than-average risk for breast cancer to undergo a risk assessment by age 25 to determine if screening before age 40 is needed.
When asked about the differing views, Debra Monticciolo, MD, division chief for breast imaging at Massachusetts General Hospital, said annual screenings that follow ACR recommendations would save more lives than the every-other-year approach backed by the task force. Dr. Monticciolo also highlighted that the available scientific evidence supports earlier assessment as well as augmented and earlier-than-age-40 screening of many women – particularly Black women.
“These evidence-based updates should spur more-informed doctor–patient conversations and help providers save more lives,” Dr. Monticciolo said in a press release.
Insurance access
Typically, upgrading a USPSTF recommendation from C to B leads to better access and insurance coverage for patients. The Affordable Care Act (ACA) of 2010 requires insurers to cover the cost of services that get A and B recommendations from the USPSTF without charging copays – a mandate intended to promote greater use for highly regarded services.
But Congress created a special workaround that effectively makes the ACA mandate apply to the 2002 task force recommendations on mammography. In those recommendations, the task force gave a B grade to screening mammograms every 1 or 2 years starting at age 40 without an age limit.
Federal lawmakers have sought to provide copay-free access to mammograms for this entire population even when the USPSTF recommendations in 2009 and 2016 gave a C grade to routine screening for women under 50.
Still, “it is important to note that our recommendation is based solely on the science of what works to prevent breast cancer and it is not a recommendation for or against insurance coverage,” the task force acknowledged when unveiling the new draft update. “Coverage decisions involve considerations beyond the evidence about clinical benefit, and in the end, these decisions are the responsibility of payors, regulators, and legislators.”
Uncertainties persist
The new draft recommendations also highlight the persistent gaps in knowledge about the uses of mammography, despite years of widespread use of this screening tool.
The updated draft recommendations emphasize the lack of sufficient evidence to address major areas of concern related to screening and treating Black women, older women, women with dense breasts, and those with ductal carcinoma in situ (DCIS).
The task force called for more research addressing the underlying causes of elevated breast cancer mortality rates among Black women.
The USPSTF also issued an ‘I’ statement for providing women with dense breasts additional screening with breast ultrasound or MRI and for screening women older than 75 for breast cancer. Such statements indicate that the available evidence is lacking, poor quality, or conflicting, and thus the USPSTF can’t assess the benefits and harms or make a recommendation for or against providing the preventive service.
“Nearly half of all women have dense breasts, which increases their risk for breast cancer and means that mammograms may not work as well for them. We need to know more about whether and how additional screening might help women with dense breasts stay healthy,” the task force explained.
The task force also called for more research on approaches to reduce the risk for overdiagnosis and overtreatment for breast lesions, such as DCIS, which are identified through screening.
One analysis – the COMET study – is currently underway to assess whether women could be spared surgery for DCIS and opt for watchful waiting instead.
“If we can find that monitoring them carefully, either with or without some sort of endocrine therapy, is just as effective in keeping patients free of invasive cancer as surgery, then I think we could help to de-escalate treatment for this very low-risk group of patients,” Shelley Hwang, MD, MPH, principal investigator of the COMET study, told this news organization in December.
The task force will accept comments from the public on this draft update through June 5.
A version of this article first appeared on Medscape.com.
The major change: USPSTF proposed reducing the recommended start age for routine screening mammograms from age 50 to age 40. The latest recommendation, which carries a B grade, also calls for screening every other year and sets a cutoff age of 74.
The task force’s A and B ratings indicate strong confidence in the evidence for benefit, meaning that clinicians should encourage their patients to get these services as appropriate.
The influential federal advisory panel last updated these recommendations in 2016. At the time, USPSTF recommended routine screening mammograms starting at age 50, and gave a C grade to starting before that.
In the 2016 recommendations, “we felt a woman could start screening in her 40s depending on how she feels about the harms and benefits in an individualized personal decision,” USPSTF member John Wong, MD, chief of clinical decision making and a primary care physician at Tufts Medical Center in Boston, said in an interview. “In this draft recommendation, we now recommend that all women get screened starting at age 40.”
Two major factors prompted the change, explained Dr. Wong. One is that more women are being diagnosed with breast cancer in their 40s. The other is that a growing body of evidence showing that Black women get breast cancer younger, are more likely to die of breast cancer, and would benefit from earlier screening.
“It is now clear that screening every other year starting at age 40 has the potential to save about 20% more lives among all women and there is even greater potential benefit for Black women, who are much more likely to die from breast cancer,” Dr. Wong said.
The American Cancer Society (ACS) called the draft recommendations a “significant positive change,” while noting that the task force recommendations only apply to women at average risk for breast cancer.
The American College of Radiology (ACR) already recommends yearly mammograms for average risk women starting at age 40. Its latest guidelines on mammography call for women at higher-than-average risk for breast cancer to undergo a risk assessment by age 25 to determine if screening before age 40 is needed.
When asked about the differing views, Debra Monticciolo, MD, division chief for breast imaging at Massachusetts General Hospital, said annual screenings that follow ACR recommendations would save more lives than the every-other-year approach backed by the task force. Dr. Monticciolo also highlighted that the available scientific evidence supports earlier assessment as well as augmented and earlier-than-age-40 screening of many women – particularly Black women.
“These evidence-based updates should spur more-informed doctor–patient conversations and help providers save more lives,” Dr. Monticciolo said in a press release.
Insurance access
Typically, upgrading a USPSTF recommendation from C to B leads to better access and insurance coverage for patients. The Affordable Care Act (ACA) of 2010 requires insurers to cover the cost of services that get A and B recommendations from the USPSTF without charging copays – a mandate intended to promote greater use for highly regarded services.
But Congress created a special workaround that effectively makes the ACA mandate apply to the 2002 task force recommendations on mammography. In those recommendations, the task force gave a B grade to screening mammograms every 1 or 2 years starting at age 40 without an age limit.
Federal lawmakers have sought to provide copay-free access to mammograms for this entire population even when the USPSTF recommendations in 2009 and 2016 gave a C grade to routine screening for women under 50.
Still, “it is important to note that our recommendation is based solely on the science of what works to prevent breast cancer and it is not a recommendation for or against insurance coverage,” the task force acknowledged when unveiling the new draft update. “Coverage decisions involve considerations beyond the evidence about clinical benefit, and in the end, these decisions are the responsibility of payors, regulators, and legislators.”
Uncertainties persist
The new draft recommendations also highlight the persistent gaps in knowledge about the uses of mammography, despite years of widespread use of this screening tool.
The updated draft recommendations emphasize the lack of sufficient evidence to address major areas of concern related to screening and treating Black women, older women, women with dense breasts, and those with ductal carcinoma in situ (DCIS).
The task force called for more research addressing the underlying causes of elevated breast cancer mortality rates among Black women.
The USPSTF also issued an ‘I’ statement for providing women with dense breasts additional screening with breast ultrasound or MRI and for screening women older than 75 for breast cancer. Such statements indicate that the available evidence is lacking, poor quality, or conflicting, and thus the USPSTF can’t assess the benefits and harms or make a recommendation for or against providing the preventive service.
“Nearly half of all women have dense breasts, which increases their risk for breast cancer and means that mammograms may not work as well for them. We need to know more about whether and how additional screening might help women with dense breasts stay healthy,” the task force explained.
The task force also called for more research on approaches to reduce the risk for overdiagnosis and overtreatment for breast lesions, such as DCIS, which are identified through screening.
One analysis – the COMET study – is currently underway to assess whether women could be spared surgery for DCIS and opt for watchful waiting instead.
“If we can find that monitoring them carefully, either with or without some sort of endocrine therapy, is just as effective in keeping patients free of invasive cancer as surgery, then I think we could help to de-escalate treatment for this very low-risk group of patients,” Shelley Hwang, MD, MPH, principal investigator of the COMET study, told this news organization in December.
The task force will accept comments from the public on this draft update through June 5.
A version of this article first appeared on Medscape.com.
FDA expands use of dapagliflozin to broader range of HF
– including HF with mildly reduced ejection fraction (HFmrEF) and with preserved ejection fraction (HFpEF).
The sodium-glucose cotransporter 2 (SGLT2) inhibitor was previously approved in the United States for adults with heart failure with reduced ejection fraction (HFrEF).
The expanded indication is based on data from the phase 3 DELIVER trial, which showed clear clinical benefits of the SGLT2 inhibitor for patients with HF regardless of left ventricular function.
In the trial, which included more than 6,200 patients, dapagliflozin led to a statistically significant and clinically meaningful early reduction in the primary composite endpoint of cardiovascular (CV) death or worsening HF for patients with HFmrEF or HFpEFF.
In addition, results of a pooled analysis of the DAPA-HF and DELIVER phase 3 trials showed a consistent benefit from dapagliflozin treatment in significantly reducing the combined endpoint of CV death or HF hospitalization across the range of LVEF.
The European Commission expanded the indication for dapagliflozin (Forxiga) to include HF across the full spectrum of LVEF in February.
The SGLT2 inhibitor is also approved for use by patients with chronic kidney disease. It was first approved in 2014 to improve glycemic control for patients with diabetes mellitus.
A version of this article first appeared on Medscape.com.
– including HF with mildly reduced ejection fraction (HFmrEF) and with preserved ejection fraction (HFpEF).
The sodium-glucose cotransporter 2 (SGLT2) inhibitor was previously approved in the United States for adults with heart failure with reduced ejection fraction (HFrEF).
The expanded indication is based on data from the phase 3 DELIVER trial, which showed clear clinical benefits of the SGLT2 inhibitor for patients with HF regardless of left ventricular function.
In the trial, which included more than 6,200 patients, dapagliflozin led to a statistically significant and clinically meaningful early reduction in the primary composite endpoint of cardiovascular (CV) death or worsening HF for patients with HFmrEF or HFpEFF.
In addition, results of a pooled analysis of the DAPA-HF and DELIVER phase 3 trials showed a consistent benefit from dapagliflozin treatment in significantly reducing the combined endpoint of CV death or HF hospitalization across the range of LVEF.
The European Commission expanded the indication for dapagliflozin (Forxiga) to include HF across the full spectrum of LVEF in February.
The SGLT2 inhibitor is also approved for use by patients with chronic kidney disease. It was first approved in 2014 to improve glycemic control for patients with diabetes mellitus.
A version of this article first appeared on Medscape.com.
– including HF with mildly reduced ejection fraction (HFmrEF) and with preserved ejection fraction (HFpEF).
The sodium-glucose cotransporter 2 (SGLT2) inhibitor was previously approved in the United States for adults with heart failure with reduced ejection fraction (HFrEF).
The expanded indication is based on data from the phase 3 DELIVER trial, which showed clear clinical benefits of the SGLT2 inhibitor for patients with HF regardless of left ventricular function.
In the trial, which included more than 6,200 patients, dapagliflozin led to a statistically significant and clinically meaningful early reduction in the primary composite endpoint of cardiovascular (CV) death or worsening HF for patients with HFmrEF or HFpEFF.
In addition, results of a pooled analysis of the DAPA-HF and DELIVER phase 3 trials showed a consistent benefit from dapagliflozin treatment in significantly reducing the combined endpoint of CV death or HF hospitalization across the range of LVEF.
The European Commission expanded the indication for dapagliflozin (Forxiga) to include HF across the full spectrum of LVEF in February.
The SGLT2 inhibitor is also approved for use by patients with chronic kidney disease. It was first approved in 2014 to improve glycemic control for patients with diabetes mellitus.
A version of this article first appeared on Medscape.com.
Veterans Will Benefit if the VA Includes Telehealth in its Access Standards
The VA MISSION Act of 2018 expanded options for veterans to receive government-paid health care from private sector community health care practitioners. The act tasked the US Department of Veterans Affairs (VA) to develop rules that determine eligibility for outside care based on appointment wait times or distance to the nearest VA facility. As a part of those standards, VA opted not to include the availability of VA telehealth in its wait time calculations—a decision that we believe was a gross misjudgment with far-reaching consequences for veterans. Excluding telehealth from the guidelines has unnecessarily restricted veterans’ access to high-quality health care and has squandered large sums of taxpayer dollars.
The VA has reviewed its initial MISSION Act eligibility standards and proposed a correction that recognizes telehealth as a valid means of providing health care to veterans who prefer that option.1 Telehealth may not have been an essential component of health care before the COVID-19 pandemic, but now it is clear that the best action VA can take is to swiftly enact its recommended change, stipulating that both VA telehealth and in-person health care constitute access to treatment. If implemented, this correction would save taxpayers an astronomical sum—according to a VA reportto Congress, about $1.1 billion in fiscal year 2021 alone.2 The cost savings from this proposed correction is reason enough to implement it. But just as importantly, increased use of VA telehealth also means higher quality, quicker, and more convenient care for veterans.
The VA is the recognized world leader in providing telehealth that is effective, timely, and veteran centric. Veterans across the country have access to telehealth services in more than 30 specialties.3 To ensure accessibility, the VA has established partnerships with major mobile broadband carriers so that veterans can receive telehealth at home without additional charges.4 The VA project Accessing Telehealth through Local Area Stations (ATLAS) brings VA telehealth to areas where existing internet infrastructure may not be adequate to support video telehealth. ATLAS is a collaboration with private organizations, including Veterans of Foreign Wars, The American Legion, and Walmart.4The agency also provides tablets to veterans who might not have access to telehealth, fostering higher access and patient satisfaction.4
The VA can initiate telehealth care rapidly. The “Anywhere to Anywhere” VA Health Care initiative and telecare hubs eliminate geographic constraints, allowing clinicians to provide team-based services across county and state lines to veterans’ homes and communities.
VA’s telehealth effort maximizes convenience for veterans. It reduces travel time, travel expenses, depletion of sick leave, and the need for childcare. Veterans with posttraumatic stress disorder or military sexual trauma who are triggered by traffic and waiting rooms, those with mobility issues, or those facing the stigma of mental health treatment often prefer to receive care in the familiarity of their home. Nonetheless, any veteran who desires an in-person appointment would continue to have that option under the proposed VA rule change.
VA telehealth is often used for mental health care, using the same evidence-based psychotherapies that VA has championed and are superior to that available in the private sector.5,6 This advantage is largely due to VA’s rigorous training, consultation, case review, care delivery, measurement standards, and integrated care model. In a recent survey of veterans engaged in mental health care, 80% reported that VA virtual care via video and/or telephone is as helpful or more helpful than in‐person services.7And yet, because of existing regulations, VA telemental health (TMH) does not qualify as access, resulting in hundreds of thousands of TMH visits being outsourced yearly to community practitioners that could be quickly and beneficially furnished by VA clinicians.
Telehealth has been shown to be as clinically effective as in-person care. A recent review of 38 meta-analyses covering telehealth with 10 medical disciplines found that for all disciplines, telehealth was as effective, if not more so, than conventional care.8 And because the likelihood of not showing up for telehealth appointments is lower than for in-person appointments, continuity of care is uninterrupted, and health care outcomes are improved.
Telehealth is health care. The VA must end the double standard that has handicapped it from including telehealth availability in determinations of eligibility for community care. The VA has voiced its intention to seek stakeholder input before implementing its proposed correction. The change is long overdue. It will save the VA a billion dollars annually while ensuring that veterans have quicker access to better treatment.
1 McDonough D. Statement of the honorable Denis McDonough Secretary of Veterans Affairs Department of Veterans Affairs (VA) before the Committee on Veterans’ Affairs United States Senate on veterans access to care. 117th Cong, 2nd Sess. September 21, 2022. Accessed May 8, 2023. https://www.veterans.senate.gov/2022/9/ensuring-veterans-timely-access-to-care-in-va-and-the-community/63b521ff-d308-449a-b3a3-918f4badb805
2 US Department of Veterans Affairs, Congressionally mandated report: access to care standards. September 2022.
3 US Department of Veterans Affairs. VA Secretary Press Conference, Thursday March 2, 2023. Accessed May 8, 2023. https://www.youtube.com/watch?v=WnkNl2whPoQ
4 US Department of Veterans Affairs, VA Telehealth: bridging the digital divide. Accessed May 8, 2023. https://telehealth.va.gov/digital-divide
5 Rand Corporation. Improving the Quality of Mental Health Care for Veterans: Lessons from RAND Research. Santa Monica, CA: RAND Corporation, 2019. https://www.rand.org/pubs/research_briefs/RB10087.html.
6 Lemle, R. Choice program expansion jeopardizes high-quality VHA mental health services. Federal Pract. 2018:35(3):18-24. [link to: https://www.mdedge.com/fedprac/article/159219/mental-health/choice-program-expansion-jeopardizes-high-quality-vha-mental
7 Campbell TM. Overview of the state of mental health care services in the VHA health care system. Presentation to the National Academies’ improving access to high-quality mental health care for veterans: a workshop. April 20, 2023. Accessed May 8, 2023. https://www.nationalacademies.org/documents/embed/link/LF2255DA3DD1C41C0A42D3BEF0989ACAECE3053A6A9B/file/D2C4B73BA6FFCAA81E6C4FC7C57020A5BA54376245AD?noSaveAs=1
8 Snoswell CL, Chelberg G, De Guzman KR, et al. The clinical effectiveness of telehealth: A systematic review of meta-analyses from 2010 to 2019. J Telemed Telecare. 2021;1357633X211022907. doi:10.1177/1357633X211022907
The VA MISSION Act of 2018 expanded options for veterans to receive government-paid health care from private sector community health care practitioners. The act tasked the US Department of Veterans Affairs (VA) to develop rules that determine eligibility for outside care based on appointment wait times or distance to the nearest VA facility. As a part of those standards, VA opted not to include the availability of VA telehealth in its wait time calculations—a decision that we believe was a gross misjudgment with far-reaching consequences for veterans. Excluding telehealth from the guidelines has unnecessarily restricted veterans’ access to high-quality health care and has squandered large sums of taxpayer dollars.
The VA has reviewed its initial MISSION Act eligibility standards and proposed a correction that recognizes telehealth as a valid means of providing health care to veterans who prefer that option.1 Telehealth may not have been an essential component of health care before the COVID-19 pandemic, but now it is clear that the best action VA can take is to swiftly enact its recommended change, stipulating that both VA telehealth and in-person health care constitute access to treatment. If implemented, this correction would save taxpayers an astronomical sum—according to a VA reportto Congress, about $1.1 billion in fiscal year 2021 alone.2 The cost savings from this proposed correction is reason enough to implement it. But just as importantly, increased use of VA telehealth also means higher quality, quicker, and more convenient care for veterans.
The VA is the recognized world leader in providing telehealth that is effective, timely, and veteran centric. Veterans across the country have access to telehealth services in more than 30 specialties.3 To ensure accessibility, the VA has established partnerships with major mobile broadband carriers so that veterans can receive telehealth at home without additional charges.4 The VA project Accessing Telehealth through Local Area Stations (ATLAS) brings VA telehealth to areas where existing internet infrastructure may not be adequate to support video telehealth. ATLAS is a collaboration with private organizations, including Veterans of Foreign Wars, The American Legion, and Walmart.4The agency also provides tablets to veterans who might not have access to telehealth, fostering higher access and patient satisfaction.4
The VA can initiate telehealth care rapidly. The “Anywhere to Anywhere” VA Health Care initiative and telecare hubs eliminate geographic constraints, allowing clinicians to provide team-based services across county and state lines to veterans’ homes and communities.
VA’s telehealth effort maximizes convenience for veterans. It reduces travel time, travel expenses, depletion of sick leave, and the need for childcare. Veterans with posttraumatic stress disorder or military sexual trauma who are triggered by traffic and waiting rooms, those with mobility issues, or those facing the stigma of mental health treatment often prefer to receive care in the familiarity of their home. Nonetheless, any veteran who desires an in-person appointment would continue to have that option under the proposed VA rule change.
VA telehealth is often used for mental health care, using the same evidence-based psychotherapies that VA has championed and are superior to that available in the private sector.5,6 This advantage is largely due to VA’s rigorous training, consultation, case review, care delivery, measurement standards, and integrated care model. In a recent survey of veterans engaged in mental health care, 80% reported that VA virtual care via video and/or telephone is as helpful or more helpful than in‐person services.7And yet, because of existing regulations, VA telemental health (TMH) does not qualify as access, resulting in hundreds of thousands of TMH visits being outsourced yearly to community practitioners that could be quickly and beneficially furnished by VA clinicians.
Telehealth has been shown to be as clinically effective as in-person care. A recent review of 38 meta-analyses covering telehealth with 10 medical disciplines found that for all disciplines, telehealth was as effective, if not more so, than conventional care.8 And because the likelihood of not showing up for telehealth appointments is lower than for in-person appointments, continuity of care is uninterrupted, and health care outcomes are improved.
Telehealth is health care. The VA must end the double standard that has handicapped it from including telehealth availability in determinations of eligibility for community care. The VA has voiced its intention to seek stakeholder input before implementing its proposed correction. The change is long overdue. It will save the VA a billion dollars annually while ensuring that veterans have quicker access to better treatment.
The VA MISSION Act of 2018 expanded options for veterans to receive government-paid health care from private sector community health care practitioners. The act tasked the US Department of Veterans Affairs (VA) to develop rules that determine eligibility for outside care based on appointment wait times or distance to the nearest VA facility. As a part of those standards, VA opted not to include the availability of VA telehealth in its wait time calculations—a decision that we believe was a gross misjudgment with far-reaching consequences for veterans. Excluding telehealth from the guidelines has unnecessarily restricted veterans’ access to high-quality health care and has squandered large sums of taxpayer dollars.
The VA has reviewed its initial MISSION Act eligibility standards and proposed a correction that recognizes telehealth as a valid means of providing health care to veterans who prefer that option.1 Telehealth may not have been an essential component of health care before the COVID-19 pandemic, but now it is clear that the best action VA can take is to swiftly enact its recommended change, stipulating that both VA telehealth and in-person health care constitute access to treatment. If implemented, this correction would save taxpayers an astronomical sum—according to a VA reportto Congress, about $1.1 billion in fiscal year 2021 alone.2 The cost savings from this proposed correction is reason enough to implement it. But just as importantly, increased use of VA telehealth also means higher quality, quicker, and more convenient care for veterans.
The VA is the recognized world leader in providing telehealth that is effective, timely, and veteran centric. Veterans across the country have access to telehealth services in more than 30 specialties.3 To ensure accessibility, the VA has established partnerships with major mobile broadband carriers so that veterans can receive telehealth at home without additional charges.4 The VA project Accessing Telehealth through Local Area Stations (ATLAS) brings VA telehealth to areas where existing internet infrastructure may not be adequate to support video telehealth. ATLAS is a collaboration with private organizations, including Veterans of Foreign Wars, The American Legion, and Walmart.4The agency also provides tablets to veterans who might not have access to telehealth, fostering higher access and patient satisfaction.4
The VA can initiate telehealth care rapidly. The “Anywhere to Anywhere” VA Health Care initiative and telecare hubs eliminate geographic constraints, allowing clinicians to provide team-based services across county and state lines to veterans’ homes and communities.
VA’s telehealth effort maximizes convenience for veterans. It reduces travel time, travel expenses, depletion of sick leave, and the need for childcare. Veterans with posttraumatic stress disorder or military sexual trauma who are triggered by traffic and waiting rooms, those with mobility issues, or those facing the stigma of mental health treatment often prefer to receive care in the familiarity of their home. Nonetheless, any veteran who desires an in-person appointment would continue to have that option under the proposed VA rule change.
VA telehealth is often used for mental health care, using the same evidence-based psychotherapies that VA has championed and are superior to that available in the private sector.5,6 This advantage is largely due to VA’s rigorous training, consultation, case review, care delivery, measurement standards, and integrated care model. In a recent survey of veterans engaged in mental health care, 80% reported that VA virtual care via video and/or telephone is as helpful or more helpful than in‐person services.7And yet, because of existing regulations, VA telemental health (TMH) does not qualify as access, resulting in hundreds of thousands of TMH visits being outsourced yearly to community practitioners that could be quickly and beneficially furnished by VA clinicians.
Telehealth has been shown to be as clinically effective as in-person care. A recent review of 38 meta-analyses covering telehealth with 10 medical disciplines found that for all disciplines, telehealth was as effective, if not more so, than conventional care.8 And because the likelihood of not showing up for telehealth appointments is lower than for in-person appointments, continuity of care is uninterrupted, and health care outcomes are improved.
Telehealth is health care. The VA must end the double standard that has handicapped it from including telehealth availability in determinations of eligibility for community care. The VA has voiced its intention to seek stakeholder input before implementing its proposed correction. The change is long overdue. It will save the VA a billion dollars annually while ensuring that veterans have quicker access to better treatment.
1 McDonough D. Statement of the honorable Denis McDonough Secretary of Veterans Affairs Department of Veterans Affairs (VA) before the Committee on Veterans’ Affairs United States Senate on veterans access to care. 117th Cong, 2nd Sess. September 21, 2022. Accessed May 8, 2023. https://www.veterans.senate.gov/2022/9/ensuring-veterans-timely-access-to-care-in-va-and-the-community/63b521ff-d308-449a-b3a3-918f4badb805
2 US Department of Veterans Affairs, Congressionally mandated report: access to care standards. September 2022.
3 US Department of Veterans Affairs. VA Secretary Press Conference, Thursday March 2, 2023. Accessed May 8, 2023. https://www.youtube.com/watch?v=WnkNl2whPoQ
4 US Department of Veterans Affairs, VA Telehealth: bridging the digital divide. Accessed May 8, 2023. https://telehealth.va.gov/digital-divide
5 Rand Corporation. Improving the Quality of Mental Health Care for Veterans: Lessons from RAND Research. Santa Monica, CA: RAND Corporation, 2019. https://www.rand.org/pubs/research_briefs/RB10087.html.
6 Lemle, R. Choice program expansion jeopardizes high-quality VHA mental health services. Federal Pract. 2018:35(3):18-24. [link to: https://www.mdedge.com/fedprac/article/159219/mental-health/choice-program-expansion-jeopardizes-high-quality-vha-mental
7 Campbell TM. Overview of the state of mental health care services in the VHA health care system. Presentation to the National Academies’ improving access to high-quality mental health care for veterans: a workshop. April 20, 2023. Accessed May 8, 2023. https://www.nationalacademies.org/documents/embed/link/LF2255DA3DD1C41C0A42D3BEF0989ACAECE3053A6A9B/file/D2C4B73BA6FFCAA81E6C4FC7C57020A5BA54376245AD?noSaveAs=1
8 Snoswell CL, Chelberg G, De Guzman KR, et al. The clinical effectiveness of telehealth: A systematic review of meta-analyses from 2010 to 2019. J Telemed Telecare. 2021;1357633X211022907. doi:10.1177/1357633X211022907
1 McDonough D. Statement of the honorable Denis McDonough Secretary of Veterans Affairs Department of Veterans Affairs (VA) before the Committee on Veterans’ Affairs United States Senate on veterans access to care. 117th Cong, 2nd Sess. September 21, 2022. Accessed May 8, 2023. https://www.veterans.senate.gov/2022/9/ensuring-veterans-timely-access-to-care-in-va-and-the-community/63b521ff-d308-449a-b3a3-918f4badb805
2 US Department of Veterans Affairs, Congressionally mandated report: access to care standards. September 2022.
3 US Department of Veterans Affairs. VA Secretary Press Conference, Thursday March 2, 2023. Accessed May 8, 2023. https://www.youtube.com/watch?v=WnkNl2whPoQ
4 US Department of Veterans Affairs, VA Telehealth: bridging the digital divide. Accessed May 8, 2023. https://telehealth.va.gov/digital-divide
5 Rand Corporation. Improving the Quality of Mental Health Care for Veterans: Lessons from RAND Research. Santa Monica, CA: RAND Corporation, 2019. https://www.rand.org/pubs/research_briefs/RB10087.html.
6 Lemle, R. Choice program expansion jeopardizes high-quality VHA mental health services. Federal Pract. 2018:35(3):18-24. [link to: https://www.mdedge.com/fedprac/article/159219/mental-health/choice-program-expansion-jeopardizes-high-quality-vha-mental
7 Campbell TM. Overview of the state of mental health care services in the VHA health care system. Presentation to the National Academies’ improving access to high-quality mental health care for veterans: a workshop. April 20, 2023. Accessed May 8, 2023. https://www.nationalacademies.org/documents/embed/link/LF2255DA3DD1C41C0A42D3BEF0989ACAECE3053A6A9B/file/D2C4B73BA6FFCAA81E6C4FC7C57020A5BA54376245AD?noSaveAs=1
8 Snoswell CL, Chelberg G, De Guzman KR, et al. The clinical effectiveness of telehealth: A systematic review of meta-analyses from 2010 to 2019. J Telemed Telecare. 2021;1357633X211022907. doi:10.1177/1357633X211022907
The federal government paid private doctors twice by mistake for veterans’ care
The U.S. federal government wrote duplicate checks to private doctors who treated veterans, costing taxpayers up to $128 million in extra payments over 5 years, a new report by a federal watchdog revealed in April.
Private doctors were paid twice in nearly 300,000 cases from 2017 to 2021 involving veterans who were eligible for Veterans Health Administration and Medicare benefits, according to the report by the Health & Human Services Office of Inspector General.
The doctors were paid by Medicare for medical services that the VHA had authorized and already paid for, the OIG reported after it conducted a 5-year audit.
Duplicate Medicare payments have doubled from $22 million in 2019 when the Veterans Community Care Program was implemented to $45 million in 2021, according to the OIG report. The program allows veterans to seek care from private doctors when the VHA can’t provide the care they need.
Roughly 1.9 million veterans every year receive government-paid health care from private doctors.
The OIG said it decided to audit Medicare’s claims because “duplicate payments were a long-standing issue.”
The problem dates back to a 1979 General Accounting Office (now the Government Accountability Office) report that found Medicare and the Department of Veterans Affairs VHA made duplicate payments of more than $72,000 for certain medical services provided to veterans, the OIG reported.
The HHS OIG’s audit examined $19.2 billion in Medicare payments for 36 million claims for individuals who enrolled in Medicare and were eligible for VA services. About 90% of those claims were for doctor evaluations and visits, according to the OIG report.
The OIG found “these duplicate payments occurred because CMS did not implement controls to address duplicate payments for services provided to individuals with Medicare and VHA benefits.”
Specifically, the OIG found that the CMS and the VHA were not sharing enrollment, claims, and payment data with each other, as required by federal law.
If CMS had access to that information, the agency could have compared the VHA claims data with existing Medicare claims data to identify duplicate claims, the OIG claimed.
The OIG recommended that CMS take the following four steps to fix the problem, which CMS has agreed to do, according to the report:
- Integrate VHA enrollment, claims, and payment data into the CMS centralized claims data system so it can identify potential fraud, waste, and abuse under the Medicare program.
- Issue guidance to medical professionals on not billing Medicare for a medical service that was authorized by the VHA.
- Establish a comprehensive data-sharing agreement with the VHA.
- Establish an internal process (such as system edits) to address duplicate payments.
“CMS previously informed [the OIG] that establishing a long-term solution to address duplicate payments will take time,” the OIG reported.
A version of this article first appeared on Medscape.com.
The U.S. federal government wrote duplicate checks to private doctors who treated veterans, costing taxpayers up to $128 million in extra payments over 5 years, a new report by a federal watchdog revealed in April.
Private doctors were paid twice in nearly 300,000 cases from 2017 to 2021 involving veterans who were eligible for Veterans Health Administration and Medicare benefits, according to the report by the Health & Human Services Office of Inspector General.
The doctors were paid by Medicare for medical services that the VHA had authorized and already paid for, the OIG reported after it conducted a 5-year audit.
Duplicate Medicare payments have doubled from $22 million in 2019 when the Veterans Community Care Program was implemented to $45 million in 2021, according to the OIG report. The program allows veterans to seek care from private doctors when the VHA can’t provide the care they need.
Roughly 1.9 million veterans every year receive government-paid health care from private doctors.
The OIG said it decided to audit Medicare’s claims because “duplicate payments were a long-standing issue.”
The problem dates back to a 1979 General Accounting Office (now the Government Accountability Office) report that found Medicare and the Department of Veterans Affairs VHA made duplicate payments of more than $72,000 for certain medical services provided to veterans, the OIG reported.
The HHS OIG’s audit examined $19.2 billion in Medicare payments for 36 million claims for individuals who enrolled in Medicare and were eligible for VA services. About 90% of those claims were for doctor evaluations and visits, according to the OIG report.
The OIG found “these duplicate payments occurred because CMS did not implement controls to address duplicate payments for services provided to individuals with Medicare and VHA benefits.”
Specifically, the OIG found that the CMS and the VHA were not sharing enrollment, claims, and payment data with each other, as required by federal law.
If CMS had access to that information, the agency could have compared the VHA claims data with existing Medicare claims data to identify duplicate claims, the OIG claimed.
The OIG recommended that CMS take the following four steps to fix the problem, which CMS has agreed to do, according to the report:
- Integrate VHA enrollment, claims, and payment data into the CMS centralized claims data system so it can identify potential fraud, waste, and abuse under the Medicare program.
- Issue guidance to medical professionals on not billing Medicare for a medical service that was authorized by the VHA.
- Establish a comprehensive data-sharing agreement with the VHA.
- Establish an internal process (such as system edits) to address duplicate payments.
“CMS previously informed [the OIG] that establishing a long-term solution to address duplicate payments will take time,” the OIG reported.
A version of this article first appeared on Medscape.com.
The U.S. federal government wrote duplicate checks to private doctors who treated veterans, costing taxpayers up to $128 million in extra payments over 5 years, a new report by a federal watchdog revealed in April.
Private doctors were paid twice in nearly 300,000 cases from 2017 to 2021 involving veterans who were eligible for Veterans Health Administration and Medicare benefits, according to the report by the Health & Human Services Office of Inspector General.
The doctors were paid by Medicare for medical services that the VHA had authorized and already paid for, the OIG reported after it conducted a 5-year audit.
Duplicate Medicare payments have doubled from $22 million in 2019 when the Veterans Community Care Program was implemented to $45 million in 2021, according to the OIG report. The program allows veterans to seek care from private doctors when the VHA can’t provide the care they need.
Roughly 1.9 million veterans every year receive government-paid health care from private doctors.
The OIG said it decided to audit Medicare’s claims because “duplicate payments were a long-standing issue.”
The problem dates back to a 1979 General Accounting Office (now the Government Accountability Office) report that found Medicare and the Department of Veterans Affairs VHA made duplicate payments of more than $72,000 for certain medical services provided to veterans, the OIG reported.
The HHS OIG’s audit examined $19.2 billion in Medicare payments for 36 million claims for individuals who enrolled in Medicare and were eligible for VA services. About 90% of those claims were for doctor evaluations and visits, according to the OIG report.
The OIG found “these duplicate payments occurred because CMS did not implement controls to address duplicate payments for services provided to individuals with Medicare and VHA benefits.”
Specifically, the OIG found that the CMS and the VHA were not sharing enrollment, claims, and payment data with each other, as required by federal law.
If CMS had access to that information, the agency could have compared the VHA claims data with existing Medicare claims data to identify duplicate claims, the OIG claimed.
The OIG recommended that CMS take the following four steps to fix the problem, which CMS has agreed to do, according to the report:
- Integrate VHA enrollment, claims, and payment data into the CMS centralized claims data system so it can identify potential fraud, waste, and abuse under the Medicare program.
- Issue guidance to medical professionals on not billing Medicare for a medical service that was authorized by the VHA.
- Establish a comprehensive data-sharing agreement with the VHA.
- Establish an internal process (such as system edits) to address duplicate payments.
“CMS previously informed [the OIG] that establishing a long-term solution to address duplicate payments will take time,” the OIG reported.
A version of this article first appeared on Medscape.com.
ASCO updates treatment guidelines for anxiety and depression
Since the last guidelines, published in 2014, screening and assessment for depression and anxiety have improved, and a large new evidence base has emerged. To ensure the most up-to-date recommendations, a group of experts spanning psychology, psychiatry, medical and surgical oncology, internal medicine, and nursing convened to review the current literature on managing depression and anxiety. The review included 61 studies – 16 meta-analyses, 44 randomized controlled trials, and one systematic review – published between 2013 and 2021.
“The purpose of this guideline update is to gather and examine the evidence published since the 2014 guideline ... [with a] focus on management and treatment only.” The overall goal is to provide “the most effective and least resource-intensive intervention based on symptom severity” for patients with cancer, the experts write.
The new clinical practice guideline addresses the following question: What are the recommended treatment approaches in the management of anxiety and/or depression in survivors of adult cancer?
After an extensive literature search and analysis, the study was published online in the Journal of Clinical Oncology.
The expert panel’s recommendations fell into three broad categories – general management principles, treatment and care options for depressive symptoms, and treatment and care options for anxiety symptoms – with the guidelines for managing depression and anxiety largely mirroring each other.
The authors caution, however, that the guidelines “were developed in the context of mental health care being available and may not be applicable within other resource settings.”
General management principals
All patients with cancer, along with their caregivers, family members, or trusted confidants, should be offered information and resources on depression and anxiety. The panel gave this a “strong” recommendation but provided the caveat that the “information should be culturally informed and linguistically appropriate and can include a conversation between clinician and patient.”
Clinicians should select the most effective and least intensive intervention based on symptom severity when selecting treatment – what the panelists referred to as a stepped-care model. History of psychiatric diagnoses or substance use as well as prior responses to mental health treatment are some of the factors that may inform treatment choice.
For patients experiencing both depression and anxiety symptoms, treatment of depressive symptoms should be prioritized.
When referring a patient for further evaluation or care, clinicians “should make every effort to reduce barriers and facilitate patient follow-through,” the authors write. And health care professionals should regularly assess the treatment responses for patients receiving psychological or pharmacological interventions.
Overall, the treatments should be “supervised by a psychiatrist, and primary care or oncology providers work collaboratively with a nurse care manager to provide psychological interventions and monitor treatment compliance and outcomes,” the panelists write. “This type of collaborative care is found to be superior to usual care and is more cost-effective than face-to-face and pharmacologic treatment for depression.”
Treatment and care options for depressive and anxiety symptoms
For patients with moderate to severe depression symptoms, the panelists again stressed that clinicians should provide “culturally informed and linguistically appropriate information.” This information may include the frequency and symptoms of depression as well as signs these symptoms may be getting worse, with contact information for the medical team provided.
Among patients with moderate symptoms, clinicians can offer patients a range of individual or group therapy options, including cognitive-behavioral therapy (CBT), behavioral activation, mindfulness-based stress reduction, or structured physical activity and exercise. For patients with severe symptoms of depression, clinicians should offer individual therapy with one of these four treatment options: CBT, behavioral activation, mindfulness-based stress reduction, or interpersonal therapy.
The panelists offered almost identical recommendations for patients with anxiety, except mindfulness-based stress reduction was an option for patients with severe symptoms.
Clinicians can also provide pharmacologic options to treat depression or anxiety in certain patients, though the panelists provided the caveat that evidence for pharmacologic management is weak.
“These guidelines make no recommendations about any specific pharmacologic regimen being better than another,” the experts wrote. And “patients should be warned of potential harm or adverse effects.”
Overall, the panelists noted that, as highlighted in the 2014 ASCO guideline, the updated version continues to stress the importance of providing education on coping with stress, anxiety, and depression.
And “for individuals with elevated symptoms, validation and normalizing patients’ experiences is crucial,” the panelists write.
Although the timing of screening is not the focus of this updated review, the experts recognized that “how and when patients with cancer and survivors are screened are important determinants of timely management of anxiety and depression.”
And unlike the prior guideline, “pharmacotherapy is not recommended as a first-line treatment, neither alone nor in combination,” the authors say.
Overall, the panelists emphasize how widespread the mental health care crisis is and that problems accessing mental health care remain. “The choice of intervention to offer patients facing such obstacles should be based on shared decision-making, taking into account availability, accessibility, patient preference, likelihood of adverse events, adherence, and cost,” the experts conclude.
A version of this article first appeared on Medscape.com.
Since the last guidelines, published in 2014, screening and assessment for depression and anxiety have improved, and a large new evidence base has emerged. To ensure the most up-to-date recommendations, a group of experts spanning psychology, psychiatry, medical and surgical oncology, internal medicine, and nursing convened to review the current literature on managing depression and anxiety. The review included 61 studies – 16 meta-analyses, 44 randomized controlled trials, and one systematic review – published between 2013 and 2021.
“The purpose of this guideline update is to gather and examine the evidence published since the 2014 guideline ... [with a] focus on management and treatment only.” The overall goal is to provide “the most effective and least resource-intensive intervention based on symptom severity” for patients with cancer, the experts write.
The new clinical practice guideline addresses the following question: What are the recommended treatment approaches in the management of anxiety and/or depression in survivors of adult cancer?
After an extensive literature search and analysis, the study was published online in the Journal of Clinical Oncology.
The expert panel’s recommendations fell into three broad categories – general management principles, treatment and care options for depressive symptoms, and treatment and care options for anxiety symptoms – with the guidelines for managing depression and anxiety largely mirroring each other.
The authors caution, however, that the guidelines “were developed in the context of mental health care being available and may not be applicable within other resource settings.”
General management principals
All patients with cancer, along with their caregivers, family members, or trusted confidants, should be offered information and resources on depression and anxiety. The panel gave this a “strong” recommendation but provided the caveat that the “information should be culturally informed and linguistically appropriate and can include a conversation between clinician and patient.”
Clinicians should select the most effective and least intensive intervention based on symptom severity when selecting treatment – what the panelists referred to as a stepped-care model. History of psychiatric diagnoses or substance use as well as prior responses to mental health treatment are some of the factors that may inform treatment choice.
For patients experiencing both depression and anxiety symptoms, treatment of depressive symptoms should be prioritized.
When referring a patient for further evaluation or care, clinicians “should make every effort to reduce barriers and facilitate patient follow-through,” the authors write. And health care professionals should regularly assess the treatment responses for patients receiving psychological or pharmacological interventions.
Overall, the treatments should be “supervised by a psychiatrist, and primary care or oncology providers work collaboratively with a nurse care manager to provide psychological interventions and monitor treatment compliance and outcomes,” the panelists write. “This type of collaborative care is found to be superior to usual care and is more cost-effective than face-to-face and pharmacologic treatment for depression.”
Treatment and care options for depressive and anxiety symptoms
For patients with moderate to severe depression symptoms, the panelists again stressed that clinicians should provide “culturally informed and linguistically appropriate information.” This information may include the frequency and symptoms of depression as well as signs these symptoms may be getting worse, with contact information for the medical team provided.
Among patients with moderate symptoms, clinicians can offer patients a range of individual or group therapy options, including cognitive-behavioral therapy (CBT), behavioral activation, mindfulness-based stress reduction, or structured physical activity and exercise. For patients with severe symptoms of depression, clinicians should offer individual therapy with one of these four treatment options: CBT, behavioral activation, mindfulness-based stress reduction, or interpersonal therapy.
The panelists offered almost identical recommendations for patients with anxiety, except mindfulness-based stress reduction was an option for patients with severe symptoms.
Clinicians can also provide pharmacologic options to treat depression or anxiety in certain patients, though the panelists provided the caveat that evidence for pharmacologic management is weak.
“These guidelines make no recommendations about any specific pharmacologic regimen being better than another,” the experts wrote. And “patients should be warned of potential harm or adverse effects.”
Overall, the panelists noted that, as highlighted in the 2014 ASCO guideline, the updated version continues to stress the importance of providing education on coping with stress, anxiety, and depression.
And “for individuals with elevated symptoms, validation and normalizing patients’ experiences is crucial,” the panelists write.
Although the timing of screening is not the focus of this updated review, the experts recognized that “how and when patients with cancer and survivors are screened are important determinants of timely management of anxiety and depression.”
And unlike the prior guideline, “pharmacotherapy is not recommended as a first-line treatment, neither alone nor in combination,” the authors say.
Overall, the panelists emphasize how widespread the mental health care crisis is and that problems accessing mental health care remain. “The choice of intervention to offer patients facing such obstacles should be based on shared decision-making, taking into account availability, accessibility, patient preference, likelihood of adverse events, adherence, and cost,” the experts conclude.
A version of this article first appeared on Medscape.com.
Since the last guidelines, published in 2014, screening and assessment for depression and anxiety have improved, and a large new evidence base has emerged. To ensure the most up-to-date recommendations, a group of experts spanning psychology, psychiatry, medical and surgical oncology, internal medicine, and nursing convened to review the current literature on managing depression and anxiety. The review included 61 studies – 16 meta-analyses, 44 randomized controlled trials, and one systematic review – published between 2013 and 2021.
“The purpose of this guideline update is to gather and examine the evidence published since the 2014 guideline ... [with a] focus on management and treatment only.” The overall goal is to provide “the most effective and least resource-intensive intervention based on symptom severity” for patients with cancer, the experts write.
The new clinical practice guideline addresses the following question: What are the recommended treatment approaches in the management of anxiety and/or depression in survivors of adult cancer?
After an extensive literature search and analysis, the study was published online in the Journal of Clinical Oncology.
The expert panel’s recommendations fell into three broad categories – general management principles, treatment and care options for depressive symptoms, and treatment and care options for anxiety symptoms – with the guidelines for managing depression and anxiety largely mirroring each other.
The authors caution, however, that the guidelines “were developed in the context of mental health care being available and may not be applicable within other resource settings.”
General management principals
All patients with cancer, along with their caregivers, family members, or trusted confidants, should be offered information and resources on depression and anxiety. The panel gave this a “strong” recommendation but provided the caveat that the “information should be culturally informed and linguistically appropriate and can include a conversation between clinician and patient.”
Clinicians should select the most effective and least intensive intervention based on symptom severity when selecting treatment – what the panelists referred to as a stepped-care model. History of psychiatric diagnoses or substance use as well as prior responses to mental health treatment are some of the factors that may inform treatment choice.
For patients experiencing both depression and anxiety symptoms, treatment of depressive symptoms should be prioritized.
When referring a patient for further evaluation or care, clinicians “should make every effort to reduce barriers and facilitate patient follow-through,” the authors write. And health care professionals should regularly assess the treatment responses for patients receiving psychological or pharmacological interventions.
Overall, the treatments should be “supervised by a psychiatrist, and primary care or oncology providers work collaboratively with a nurse care manager to provide psychological interventions and monitor treatment compliance and outcomes,” the panelists write. “This type of collaborative care is found to be superior to usual care and is more cost-effective than face-to-face and pharmacologic treatment for depression.”
Treatment and care options for depressive and anxiety symptoms
For patients with moderate to severe depression symptoms, the panelists again stressed that clinicians should provide “culturally informed and linguistically appropriate information.” This information may include the frequency and symptoms of depression as well as signs these symptoms may be getting worse, with contact information for the medical team provided.
Among patients with moderate symptoms, clinicians can offer patients a range of individual or group therapy options, including cognitive-behavioral therapy (CBT), behavioral activation, mindfulness-based stress reduction, or structured physical activity and exercise. For patients with severe symptoms of depression, clinicians should offer individual therapy with one of these four treatment options: CBT, behavioral activation, mindfulness-based stress reduction, or interpersonal therapy.
The panelists offered almost identical recommendations for patients with anxiety, except mindfulness-based stress reduction was an option for patients with severe symptoms.
Clinicians can also provide pharmacologic options to treat depression or anxiety in certain patients, though the panelists provided the caveat that evidence for pharmacologic management is weak.
“These guidelines make no recommendations about any specific pharmacologic regimen being better than another,” the experts wrote. And “patients should be warned of potential harm or adverse effects.”
Overall, the panelists noted that, as highlighted in the 2014 ASCO guideline, the updated version continues to stress the importance of providing education on coping with stress, anxiety, and depression.
And “for individuals with elevated symptoms, validation and normalizing patients’ experiences is crucial,” the panelists write.
Although the timing of screening is not the focus of this updated review, the experts recognized that “how and when patients with cancer and survivors are screened are important determinants of timely management of anxiety and depression.”
And unlike the prior guideline, “pharmacotherapy is not recommended as a first-line treatment, neither alone nor in combination,” the authors say.
Overall, the panelists emphasize how widespread the mental health care crisis is and that problems accessing mental health care remain. “The choice of intervention to offer patients facing such obstacles should be based on shared decision-making, taking into account availability, accessibility, patient preference, likelihood of adverse events, adherence, and cost,” the experts conclude.
A version of this article first appeared on Medscape.com.
FROM THE JOURNAL OF CLINICAL ONCOLOGY
Federal rules don’t require period product ingredients on packaging labels. States are stepping in.
Tens of millions of Americans use menstrual products, and while manufacturers contend they are safe, most disclose little about the chemicals they contain. Now, amid calls for more disclosure and research into the health effects of these products, some states require more transparency.
The manufacture and sale of period and related products is a big business, with revenue expected to top $4.5 billion in the United States this year. On average, a person uses up to 17,000 tampons or pads in their lifetime, and they might also use rubber or silicone cups, or absorbent period underwear.
The FDA regulates and classifies menstrual products as medical devices, meaning they are not subject to the same labeling laws as other consumer items. But companies can voluntarily disclose what’s in their products.
Now, some states are stepping into the breach. In 2021, New York became the first state to enact a menstrual product disclosure law requiring companies to list all intentionally added ingredients on packaging. California’s governor signed a similar law that took effect this year, but it gives manufacturers trade secret protections, so not all ingredients are necessarily disclosed. At least six other states have introduced legislation to address safety and disclosure of ingredients in these products.
Shruthi Mahalingaiah, an assistant professor of environmental, reproductive, and women’s health at Harvard University, Boston, evaluates endocrine disruptors in personal care products and studies menstrual health. She said the health risk depends on the dose, duration, and sensitivity of a person to the ingredients and their mixtures.
Harmful chemicals could come from manufacturing processes, through materials and shipping, from equipment cleaners, from contact with contaminants, or from companies adding them intentionally, said Alexandra Scranton, director of science and research for Women’s Voices for the Earth, a Montana-based nonprofit focused on eliminating toxic chemicals that affect women’s health.
Vaginal and vulvar tissues are capable of absorbing fluids at a higher rate than skin, which can lead to rapid chemical exposure. Ms. Scranton said scarcity of clinical studies and funding for vaginal health research limits understanding about the long-term effects of the ingredients and additives in period products.
“We think manufacturers should do better and be more careful with the ingredients they choose to use,” Ms. Scranton said. “The presence of toxic and hormone-disrupting chemicals in menstrual products is unsettling. We know that chemicals can cause disease, and exposures do add up over time.”
Ms. Scranton’s organization advocates for labels to include the chemical name of the ingredient, the component in which the ingredient is used, and the function of the ingredient.
K. Malaika Walton, operations director for the Center for Baby and Adult Hygiene Products, a trade industry group, said in an email, “BAHP supports accurate and transparent information for users of period products and many of our member companies list ingredients on their packages and websites.”
In a written statement, Procter & Gamble, a major manufacturer of menstrual products, said that ingredients it uses go through rigorous safety evaluations and are continuously tested, and that all fragrance components are added at levels the industry considers safe.
Even though manufacturing of scented tampons for the U.S. market has mostly stopped, companies still use fragrances in other menstrual products. Laws protecting trade secrets keep details about fragrances in pads and tampons confidential so competitors can’t copy the formulas. The Children’s Environmental Health Network lists phthalates, a group of chemicals commonly called plasticizers, that are suspected hormone disruptors, as an ingredient found in fragrances.
Manufacturers follow regulatory guidance issued in 2005 by registering with the Food and Drug Administration and submitting a detailed risk assessment of their products’ components and design, and a safety profile, before being cleared to sell in the United States.
Pads and menstrual cups are considered exempt from regulatory guidance and do not require premarket review, according to FDA spokesperson Carly Kempler. While tampons do require review, the FDA “does not clear or approve individual materials that are used in the fabrication of medical devices.”
“There’s an understanding that the FDA is regulating these products, and they are; it’s just not very adequate,” said Laura Strausfeld, an attorney and a cofounder of Period Law, an organization working to advance state and federal period-equity policies that would stop taxation of products and make them freely available in places like schools and prisons. “The consumer is supposed to trust that when these products are put on shelves they’ve been vetted by the government. But it’s basically a rubber stamp.”
In a 2022 report, a congressional committee directed the FDA to update its guidance for menstrual products to recommend that labels disclose intentionally added ingredients, such as fragrances, and test for contaminants. The FDA is reviewing the directives outlined by the House Appropriations Committee and will update the 2005 guidance as soon as possible, Ms. Kempler said. “We will share additional details when we are able to.”
At least one period product company makes disclosure of its ingredients a selling point. Alex Friedman, cofounder of Lola, said a lack of knowledge is a problem, and more action and awareness are needed to keep people safe.
“The hardest part to swallow is why this is even up for debate. We should all know what’s in these products,” Ms. Friedman said.
New York’s law requires companies to disclose all intentionally added ingredients no matter how much is used, with no trade secret protections for fragrances. Though it applies only to products sold in that state, similar detailed labeling is appearing elsewhere, advocates said.
“We’re also seeing similar or identical disclosure on packaging in other states outside of New York, which is a testament to the power of the law,” said Jamie McConnell, deputy director of Women’s Voices for the Earth.
Manufacturers have 18 months from the passage of the New York law to comply, and some products on shelves in New York still list few ingredients other than “absorbent material,” “surfactant,” “ink,” and “adhesive.”
“We’re like, ‘OK, what is that exactly?’ ” Ms. McConnell said.
Her organization is calling for a federal law at least as strong as New York’s. Previous federal legislation failed to advance, including the most recent, the Menstrual Products Right to Know Act, introduced in 2022.
BAHP, the trade group, supported the federal legislation and the California law. Ms. McConnell said she opposed both bills because they didn’t require companies to list all fragrance ingredients.
“I think what it boiled down to at the federal level was the support of corporate interests over public health,” she said.
KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.
Tens of millions of Americans use menstrual products, and while manufacturers contend they are safe, most disclose little about the chemicals they contain. Now, amid calls for more disclosure and research into the health effects of these products, some states require more transparency.
The manufacture and sale of period and related products is a big business, with revenue expected to top $4.5 billion in the United States this year. On average, a person uses up to 17,000 tampons or pads in their lifetime, and they might also use rubber or silicone cups, or absorbent period underwear.
The FDA regulates and classifies menstrual products as medical devices, meaning they are not subject to the same labeling laws as other consumer items. But companies can voluntarily disclose what’s in their products.
Now, some states are stepping into the breach. In 2021, New York became the first state to enact a menstrual product disclosure law requiring companies to list all intentionally added ingredients on packaging. California’s governor signed a similar law that took effect this year, but it gives manufacturers trade secret protections, so not all ingredients are necessarily disclosed. At least six other states have introduced legislation to address safety and disclosure of ingredients in these products.
Shruthi Mahalingaiah, an assistant professor of environmental, reproductive, and women’s health at Harvard University, Boston, evaluates endocrine disruptors in personal care products and studies menstrual health. She said the health risk depends on the dose, duration, and sensitivity of a person to the ingredients and their mixtures.
Harmful chemicals could come from manufacturing processes, through materials and shipping, from equipment cleaners, from contact with contaminants, or from companies adding them intentionally, said Alexandra Scranton, director of science and research for Women’s Voices for the Earth, a Montana-based nonprofit focused on eliminating toxic chemicals that affect women’s health.
Vaginal and vulvar tissues are capable of absorbing fluids at a higher rate than skin, which can lead to rapid chemical exposure. Ms. Scranton said scarcity of clinical studies and funding for vaginal health research limits understanding about the long-term effects of the ingredients and additives in period products.
“We think manufacturers should do better and be more careful with the ingredients they choose to use,” Ms. Scranton said. “The presence of toxic and hormone-disrupting chemicals in menstrual products is unsettling. We know that chemicals can cause disease, and exposures do add up over time.”
Ms. Scranton’s organization advocates for labels to include the chemical name of the ingredient, the component in which the ingredient is used, and the function of the ingredient.
K. Malaika Walton, operations director for the Center for Baby and Adult Hygiene Products, a trade industry group, said in an email, “BAHP supports accurate and transparent information for users of period products and many of our member companies list ingredients on their packages and websites.”
In a written statement, Procter & Gamble, a major manufacturer of menstrual products, said that ingredients it uses go through rigorous safety evaluations and are continuously tested, and that all fragrance components are added at levels the industry considers safe.
Even though manufacturing of scented tampons for the U.S. market has mostly stopped, companies still use fragrances in other menstrual products. Laws protecting trade secrets keep details about fragrances in pads and tampons confidential so competitors can’t copy the formulas. The Children’s Environmental Health Network lists phthalates, a group of chemicals commonly called plasticizers, that are suspected hormone disruptors, as an ingredient found in fragrances.
Manufacturers follow regulatory guidance issued in 2005 by registering with the Food and Drug Administration and submitting a detailed risk assessment of their products’ components and design, and a safety profile, before being cleared to sell in the United States.
Pads and menstrual cups are considered exempt from regulatory guidance and do not require premarket review, according to FDA spokesperson Carly Kempler. While tampons do require review, the FDA “does not clear or approve individual materials that are used in the fabrication of medical devices.”
“There’s an understanding that the FDA is regulating these products, and they are; it’s just not very adequate,” said Laura Strausfeld, an attorney and a cofounder of Period Law, an organization working to advance state and federal period-equity policies that would stop taxation of products and make them freely available in places like schools and prisons. “The consumer is supposed to trust that when these products are put on shelves they’ve been vetted by the government. But it’s basically a rubber stamp.”
In a 2022 report, a congressional committee directed the FDA to update its guidance for menstrual products to recommend that labels disclose intentionally added ingredients, such as fragrances, and test for contaminants. The FDA is reviewing the directives outlined by the House Appropriations Committee and will update the 2005 guidance as soon as possible, Ms. Kempler said. “We will share additional details when we are able to.”
At least one period product company makes disclosure of its ingredients a selling point. Alex Friedman, cofounder of Lola, said a lack of knowledge is a problem, and more action and awareness are needed to keep people safe.
“The hardest part to swallow is why this is even up for debate. We should all know what’s in these products,” Ms. Friedman said.
New York’s law requires companies to disclose all intentionally added ingredients no matter how much is used, with no trade secret protections for fragrances. Though it applies only to products sold in that state, similar detailed labeling is appearing elsewhere, advocates said.
“We’re also seeing similar or identical disclosure on packaging in other states outside of New York, which is a testament to the power of the law,” said Jamie McConnell, deputy director of Women’s Voices for the Earth.
Manufacturers have 18 months from the passage of the New York law to comply, and some products on shelves in New York still list few ingredients other than “absorbent material,” “surfactant,” “ink,” and “adhesive.”
“We’re like, ‘OK, what is that exactly?’ ” Ms. McConnell said.
Her organization is calling for a federal law at least as strong as New York’s. Previous federal legislation failed to advance, including the most recent, the Menstrual Products Right to Know Act, introduced in 2022.
BAHP, the trade group, supported the federal legislation and the California law. Ms. McConnell said she opposed both bills because they didn’t require companies to list all fragrance ingredients.
“I think what it boiled down to at the federal level was the support of corporate interests over public health,” she said.
KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.
Tens of millions of Americans use menstrual products, and while manufacturers contend they are safe, most disclose little about the chemicals they contain. Now, amid calls for more disclosure and research into the health effects of these products, some states require more transparency.
The manufacture and sale of period and related products is a big business, with revenue expected to top $4.5 billion in the United States this year. On average, a person uses up to 17,000 tampons or pads in their lifetime, and they might also use rubber or silicone cups, or absorbent period underwear.
The FDA regulates and classifies menstrual products as medical devices, meaning they are not subject to the same labeling laws as other consumer items. But companies can voluntarily disclose what’s in their products.
Now, some states are stepping into the breach. In 2021, New York became the first state to enact a menstrual product disclosure law requiring companies to list all intentionally added ingredients on packaging. California’s governor signed a similar law that took effect this year, but it gives manufacturers trade secret protections, so not all ingredients are necessarily disclosed. At least six other states have introduced legislation to address safety and disclosure of ingredients in these products.
Shruthi Mahalingaiah, an assistant professor of environmental, reproductive, and women’s health at Harvard University, Boston, evaluates endocrine disruptors in personal care products and studies menstrual health. She said the health risk depends on the dose, duration, and sensitivity of a person to the ingredients and their mixtures.
Harmful chemicals could come from manufacturing processes, through materials and shipping, from equipment cleaners, from contact with contaminants, or from companies adding them intentionally, said Alexandra Scranton, director of science and research for Women’s Voices for the Earth, a Montana-based nonprofit focused on eliminating toxic chemicals that affect women’s health.
Vaginal and vulvar tissues are capable of absorbing fluids at a higher rate than skin, which can lead to rapid chemical exposure. Ms. Scranton said scarcity of clinical studies and funding for vaginal health research limits understanding about the long-term effects of the ingredients and additives in period products.
“We think manufacturers should do better and be more careful with the ingredients they choose to use,” Ms. Scranton said. “The presence of toxic and hormone-disrupting chemicals in menstrual products is unsettling. We know that chemicals can cause disease, and exposures do add up over time.”
Ms. Scranton’s organization advocates for labels to include the chemical name of the ingredient, the component in which the ingredient is used, and the function of the ingredient.
K. Malaika Walton, operations director for the Center for Baby and Adult Hygiene Products, a trade industry group, said in an email, “BAHP supports accurate and transparent information for users of period products and many of our member companies list ingredients on their packages and websites.”
In a written statement, Procter & Gamble, a major manufacturer of menstrual products, said that ingredients it uses go through rigorous safety evaluations and are continuously tested, and that all fragrance components are added at levels the industry considers safe.
Even though manufacturing of scented tampons for the U.S. market has mostly stopped, companies still use fragrances in other menstrual products. Laws protecting trade secrets keep details about fragrances in pads and tampons confidential so competitors can’t copy the formulas. The Children’s Environmental Health Network lists phthalates, a group of chemicals commonly called plasticizers, that are suspected hormone disruptors, as an ingredient found in fragrances.
Manufacturers follow regulatory guidance issued in 2005 by registering with the Food and Drug Administration and submitting a detailed risk assessment of their products’ components and design, and a safety profile, before being cleared to sell in the United States.
Pads and menstrual cups are considered exempt from regulatory guidance and do not require premarket review, according to FDA spokesperson Carly Kempler. While tampons do require review, the FDA “does not clear or approve individual materials that are used in the fabrication of medical devices.”
“There’s an understanding that the FDA is regulating these products, and they are; it’s just not very adequate,” said Laura Strausfeld, an attorney and a cofounder of Period Law, an organization working to advance state and federal period-equity policies that would stop taxation of products and make them freely available in places like schools and prisons. “The consumer is supposed to trust that when these products are put on shelves they’ve been vetted by the government. But it’s basically a rubber stamp.”
In a 2022 report, a congressional committee directed the FDA to update its guidance for menstrual products to recommend that labels disclose intentionally added ingredients, such as fragrances, and test for contaminants. The FDA is reviewing the directives outlined by the House Appropriations Committee and will update the 2005 guidance as soon as possible, Ms. Kempler said. “We will share additional details when we are able to.”
At least one period product company makes disclosure of its ingredients a selling point. Alex Friedman, cofounder of Lola, said a lack of knowledge is a problem, and more action and awareness are needed to keep people safe.
“The hardest part to swallow is why this is even up for debate. We should all know what’s in these products,” Ms. Friedman said.
New York’s law requires companies to disclose all intentionally added ingredients no matter how much is used, with no trade secret protections for fragrances. Though it applies only to products sold in that state, similar detailed labeling is appearing elsewhere, advocates said.
“We’re also seeing similar or identical disclosure on packaging in other states outside of New York, which is a testament to the power of the law,” said Jamie McConnell, deputy director of Women’s Voices for the Earth.
Manufacturers have 18 months from the passage of the New York law to comply, and some products on shelves in New York still list few ingredients other than “absorbent material,” “surfactant,” “ink,” and “adhesive.”
“We’re like, ‘OK, what is that exactly?’ ” Ms. McConnell said.
Her organization is calling for a federal law at least as strong as New York’s. Previous federal legislation failed to advance, including the most recent, the Menstrual Products Right to Know Act, introduced in 2022.
BAHP, the trade group, supported the federal legislation and the California law. Ms. McConnell said she opposed both bills because they didn’t require companies to list all fragrance ingredients.
“I think what it boiled down to at the federal level was the support of corporate interests over public health,” she said.
KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.