Health Policy

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.

The American Society of Clinical Oncology has released updated guidelines for treating anxiety and depression in adult cancer survivors.

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.

The American Society of Clinical Oncology has released updated guidelines for treating anxiety and depression in adult cancer survivors.

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.

The American Society of Clinical Oncology has released updated guidelines for treating anxiety and depression in adult cancer survivors.

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.

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.

Advocacy groups studying the effects of the New York law say the new labels have revealed commonly found ingredients in menstrual products that may contain carcinogens, reproductive toxicants, endocrine disruptors, and allergens.

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.

Advocacy groups studying the effects of the New York law say the new labels have revealed commonly found ingredients in menstrual products that may contain carcinogens, reproductive toxicants, endocrine disruptors, and allergens.

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.

Advocacy groups studying the effects of the New York law say the new labels have revealed commonly found ingredients in menstrual products that may contain carcinogens, reproductive toxicants, endocrine disruptors, and allergens.

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.

The U.S. Food and Drug Administration has granted Fast Track designation for Cabaletta Bio’s cell therapy CABA-201 for the treatment of systemic lupus erythematosus (SLE) and lupus nephritis (LN), the company announced May 1.
 

The FDA cleared Cabaletta to begin a phase 1/2 clinical trial of CABA-201, the statement says, which will be the first trial accessing Cabaletta’s Chimeric Antigen Receptor T cells for Autoimmunity (CARTA) approach. CABA-201, a 4-1BB–containing fully human CD19-CAR T-cell investigational therapy, is designed to target and deplete CD19-positive B cells, “enabling an ‘immune system reset’ with durable remission in patients with SLE,” according to the press release. This news organization previously reported on a small study in Germany, published in Nature Medicine, that also used anti-CD19 CAR T cells to treat five patients with SLE.

Wikimedia Commons/FitzColinGerald/Creative Commons License

This upcoming open-label study will enroll two cohorts containing six patients each. One cohort will be patients with SLE and active LN, and the other will be patients with SLE without renal involvement. The therapy is designed as a one-time infusion and will be administered at a dose of 1.0 x 106 cells/kg.

“We believe the FDA’s decision to grant Fast Track Designation for CABA-201 underscores the unmet need for a treatment that has the potential to provide deep and durable responses for people living with lupus and potentially other autoimmune diseases where B cells contribute to disease,” David J. Chang, MD, chief medical officer of Cabaletta, said in the press release.

FDA Fast Track is a process designed to expedite the development and review of drugs and other therapeutics that treat serious conditions and address unmet medical needs. Companies that receive Fast Track designation for a drug have the opportunity for more frequent meetings and written communication with the FDA about the drug’s development plan and design of clinical trials. The fast-tracked drug can also be eligible for accelerated approval and priority review if relevant criteria are met.

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

The U.S. Food and Drug Administration has granted Fast Track designation for Cabaletta Bio’s cell therapy CABA-201 for the treatment of systemic lupus erythematosus (SLE) and lupus nephritis (LN), the company announced May 1.
 

The FDA cleared Cabaletta to begin a phase 1/2 clinical trial of CABA-201, the statement says, which will be the first trial accessing Cabaletta’s Chimeric Antigen Receptor T cells for Autoimmunity (CARTA) approach. CABA-201, a 4-1BB–containing fully human CD19-CAR T-cell investigational therapy, is designed to target and deplete CD19-positive B cells, “enabling an ‘immune system reset’ with durable remission in patients with SLE,” according to the press release. This news organization previously reported on a small study in Germany, published in Nature Medicine, that also used anti-CD19 CAR T cells to treat five patients with SLE.

Wikimedia Commons/FitzColinGerald/Creative Commons License

This upcoming open-label study will enroll two cohorts containing six patients each. One cohort will be patients with SLE and active LN, and the other will be patients with SLE without renal involvement. The therapy is designed as a one-time infusion and will be administered at a dose of 1.0 x 106 cells/kg.

“We believe the FDA’s decision to grant Fast Track Designation for CABA-201 underscores the unmet need for a treatment that has the potential to provide deep and durable responses for people living with lupus and potentially other autoimmune diseases where B cells contribute to disease,” David J. Chang, MD, chief medical officer of Cabaletta, said in the press release.

FDA Fast Track is a process designed to expedite the development and review of drugs and other therapeutics that treat serious conditions and address unmet medical needs. Companies that receive Fast Track designation for a drug have the opportunity for more frequent meetings and written communication with the FDA about the drug’s development plan and design of clinical trials. The fast-tracked drug can also be eligible for accelerated approval and priority review if relevant criteria are met.

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

The U.S. Food and Drug Administration has granted Fast Track designation for Cabaletta Bio’s cell therapy CABA-201 for the treatment of systemic lupus erythematosus (SLE) and lupus nephritis (LN), the company announced May 1.
 

The FDA cleared Cabaletta to begin a phase 1/2 clinical trial of CABA-201, the statement says, which will be the first trial accessing Cabaletta’s Chimeric Antigen Receptor T cells for Autoimmunity (CARTA) approach. CABA-201, a 4-1BB–containing fully human CD19-CAR T-cell investigational therapy, is designed to target and deplete CD19-positive B cells, “enabling an ‘immune system reset’ with durable remission in patients with SLE,” according to the press release. This news organization previously reported on a small study in Germany, published in Nature Medicine, that also used anti-CD19 CAR T cells to treat five patients with SLE.

Wikimedia Commons/FitzColinGerald/Creative Commons License

This upcoming open-label study will enroll two cohorts containing six patients each. One cohort will be patients with SLE and active LN, and the other will be patients with SLE without renal involvement. The therapy is designed as a one-time infusion and will be administered at a dose of 1.0 x 106 cells/kg.

“We believe the FDA’s decision to grant Fast Track Designation for CABA-201 underscores the unmet need for a treatment that has the potential to provide deep and durable responses for people living with lupus and potentially other autoimmune diseases where B cells contribute to disease,” David J. Chang, MD, chief medical officer of Cabaletta, said in the press release.

FDA Fast Track is a process designed to expedite the development and review of drugs and other therapeutics that treat serious conditions and address unmet medical needs. Companies that receive Fast Track designation for a drug have the opportunity for more frequent meetings and written communication with the FDA about the drug’s development plan and design of clinical trials. The fast-tracked drug can also be eligible for accelerated approval and priority review if relevant criteria are met.

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

The U.S. Food and Drug Administration (FDA) has approved the first vaccine for respiratory syncytial virus (RSV) in the United States, the agency announced May 3. Arexvy, manufactured by GSK, is the world’s first RSV vaccine for adults aged 60 years and older,the company said in an announcement.

Every year, RSV is responsible for 60,000–120,000 hospitalizations and 6,000–10,000 deaths among U.S. adults older than age, according to the FDA. Older adults with underlying health conditions — such as diabetes, a weakened immune system, or lung or heart disease — are at high risk for severe disease. "Today’s approval of the first RSV vaccine is an important public health achievement to prevent a disease which can be life-threatening and reflects the FDA’s continued commitment to facilitating the development of safe and effective vaccines for use in the United States," said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, in a statement.

The FDA approval of Arexvy was based on a clinical study of approximately 25,000 patients. Half of these patients received Arexvy, while the other half received a placebo. Researchers found that the RSV vaccine reduced RSV-associated lower respiratory tract disease (LRTD) by nearly 83% and reduced the risk of developing severe RSV-associated LRTD by 94%. The most commonly reported side effects were injection site pain, fatigue, muscle pain, headache, and joint stiffness/pain. Ten patients who received Arexvy and four patients who received placebo experienced atrial fibrillation within 30 days of vaccination. The company is planning to assess risk for atrial fibrillation in postmarking studies, the FDA said. The European Medicine Agency’s Committee for Medicinal Products for Human Use recommended approval of Arexvy on April 25, 2023, on the basis of data from the same clinical trial.

GSK said that the U.S. launch of Arexvy will occur sometime in the fall before the 2023/2024 RSV season, but the company did not provide exact dates. "Today marks a turning point in our effort to reduce the significant burden of RSV," said GSK’s chief scientific officer, Tony Wood, PhD, in a company statement. "Our focus now is to ensure eligible older adults in the U.S. can access the vaccine as quickly as possible and to progress regulatory review in other countries."

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

The U.S. Food and Drug Administration (FDA) has approved the first vaccine for respiratory syncytial virus (RSV) in the United States, the agency announced May 3. Arexvy, manufactured by GSK, is the world’s first RSV vaccine for adults aged 60 years and older,the company said in an announcement.

Every year, RSV is responsible for 60,000–120,000 hospitalizations and 6,000–10,000 deaths among U.S. adults older than age, according to the FDA. Older adults with underlying health conditions — such as diabetes, a weakened immune system, or lung or heart disease — are at high risk for severe disease. "Today’s approval of the first RSV vaccine is an important public health achievement to prevent a disease which can be life-threatening and reflects the FDA’s continued commitment to facilitating the development of safe and effective vaccines for use in the United States," said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, in a statement.

The FDA approval of Arexvy was based on a clinical study of approximately 25,000 patients. Half of these patients received Arexvy, while the other half received a placebo. Researchers found that the RSV vaccine reduced RSV-associated lower respiratory tract disease (LRTD) by nearly 83% and reduced the risk of developing severe RSV-associated LRTD by 94%. The most commonly reported side effects were injection site pain, fatigue, muscle pain, headache, and joint stiffness/pain. Ten patients who received Arexvy and four patients who received placebo experienced atrial fibrillation within 30 days of vaccination. The company is planning to assess risk for atrial fibrillation in postmarking studies, the FDA said. The European Medicine Agency’s Committee for Medicinal Products for Human Use recommended approval of Arexvy on April 25, 2023, on the basis of data from the same clinical trial.

GSK said that the U.S. launch of Arexvy will occur sometime in the fall before the 2023/2024 RSV season, but the company did not provide exact dates. "Today marks a turning point in our effort to reduce the significant burden of RSV," said GSK’s chief scientific officer, Tony Wood, PhD, in a company statement. "Our focus now is to ensure eligible older adults in the U.S. can access the vaccine as quickly as possible and to progress regulatory review in other countries."

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

The U.S. Food and Drug Administration (FDA) has approved the first vaccine for respiratory syncytial virus (RSV) in the United States, the agency announced May 3. Arexvy, manufactured by GSK, is the world’s first RSV vaccine for adults aged 60 years and older,the company said in an announcement.

Every year, RSV is responsible for 60,000–120,000 hospitalizations and 6,000–10,000 deaths among U.S. adults older than age, according to the FDA. Older adults with underlying health conditions — such as diabetes, a weakened immune system, or lung or heart disease — are at high risk for severe disease. "Today’s approval of the first RSV vaccine is an important public health achievement to prevent a disease which can be life-threatening and reflects the FDA’s continued commitment to facilitating the development of safe and effective vaccines for use in the United States," said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, in a statement.

The FDA approval of Arexvy was based on a clinical study of approximately 25,000 patients. Half of these patients received Arexvy, while the other half received a placebo. Researchers found that the RSV vaccine reduced RSV-associated lower respiratory tract disease (LRTD) by nearly 83% and reduced the risk of developing severe RSV-associated LRTD by 94%. The most commonly reported side effects were injection site pain, fatigue, muscle pain, headache, and joint stiffness/pain. Ten patients who received Arexvy and four patients who received placebo experienced atrial fibrillation within 30 days of vaccination. The company is planning to assess risk for atrial fibrillation in postmarking studies, the FDA said. The European Medicine Agency’s Committee for Medicinal Products for Human Use recommended approval of Arexvy on April 25, 2023, on the basis of data from the same clinical trial.

GSK said that the U.S. launch of Arexvy will occur sometime in the fall before the 2023/2024 RSV season, but the company did not provide exact dates. "Today marks a turning point in our effort to reduce the significant burden of RSV," said GSK’s chief scientific officer, Tony Wood, PhD, in a company statement. "Our focus now is to ensure eligible older adults in the U.S. can access the vaccine as quickly as possible and to progress regulatory review in other countries."

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

The U.S. government plans to no longer require federal workers or international air travelers to be vaccinated for COVID-19, the Biden administration has announced. 

The move means vaccines will no longer be required for workers who are federal employees, federal contractors, Head Start early education employees, workers at Medicare-certified health care facilities, and those who work at U.S. borders. International air travelers will no longer be required to prove their vaccination status. The requirement will be lifted at the end of the day on May 11, which is also when the federal public health emergency declaration ends.

“While vaccination remains one of the most important tools in advancing the health and safety of employees and promoting the efficiency of workplaces, we are now in a different phase of our response when these measures are no longer necessary,” an announcement from the White House stated.

White House officials credited vaccine requirements with saving millions of lives, noting that the rules ensured “the safety of workers in critical workforces including those in the healthcare and education sectors, protecting themselves and the populations they serve, and strengthening their ability to provide services without disruptions to operations.”

More than 100 million people were subject to the vaccine requirement, The Associated Press reported. All but 2% of those covered by the mandate had received at least one dose or had a pending or approved exception on file by January 2022, the Biden administration said, noting that COVID deaths have dropped 95% since January 2021 and hospitalizations are down nearly 91%.

In January, vaccine requirements were lifted for U.S. military members.

On the government-run website Safer Federal Workforce, which helped affected organizations put federal COVID rules into place, agencies were told to “take no action to implement or enforce the COVID-19 vaccination requirement” at this time.

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

The U.S. government plans to no longer require federal workers or international air travelers to be vaccinated for COVID-19, the Biden administration has announced. 

The move means vaccines will no longer be required for workers who are federal employees, federal contractors, Head Start early education employees, workers at Medicare-certified health care facilities, and those who work at U.S. borders. International air travelers will no longer be required to prove their vaccination status. The requirement will be lifted at the end of the day on May 11, which is also when the federal public health emergency declaration ends.

“While vaccination remains one of the most important tools in advancing the health and safety of employees and promoting the efficiency of workplaces, we are now in a different phase of our response when these measures are no longer necessary,” an announcement from the White House stated.

White House officials credited vaccine requirements with saving millions of lives, noting that the rules ensured “the safety of workers in critical workforces including those in the healthcare and education sectors, protecting themselves and the populations they serve, and strengthening their ability to provide services without disruptions to operations.”

More than 100 million people were subject to the vaccine requirement, The Associated Press reported. All but 2% of those covered by the mandate had received at least one dose or had a pending or approved exception on file by January 2022, the Biden administration said, noting that COVID deaths have dropped 95% since January 2021 and hospitalizations are down nearly 91%.

In January, vaccine requirements were lifted for U.S. military members.

On the government-run website Safer Federal Workforce, which helped affected organizations put federal COVID rules into place, agencies were told to “take no action to implement or enforce the COVID-19 vaccination requirement” at this time.

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

The U.S. government plans to no longer require federal workers or international air travelers to be vaccinated for COVID-19, the Biden administration has announced. 

The move means vaccines will no longer be required for workers who are federal employees, federal contractors, Head Start early education employees, workers at Medicare-certified health care facilities, and those who work at U.S. borders. International air travelers will no longer be required to prove their vaccination status. The requirement will be lifted at the end of the day on May 11, which is also when the federal public health emergency declaration ends.

“While vaccination remains one of the most important tools in advancing the health and safety of employees and promoting the efficiency of workplaces, we are now in a different phase of our response when these measures are no longer necessary,” an announcement from the White House stated.

White House officials credited vaccine requirements with saving millions of lives, noting that the rules ensured “the safety of workers in critical workforces including those in the healthcare and education sectors, protecting themselves and the populations they serve, and strengthening their ability to provide services without disruptions to operations.”

More than 100 million people were subject to the vaccine requirement, The Associated Press reported. All but 2% of those covered by the mandate had received at least one dose or had a pending or approved exception on file by January 2022, the Biden administration said, noting that COVID deaths have dropped 95% since January 2021 and hospitalizations are down nearly 91%.

In January, vaccine requirements were lifted for U.S. military members.

On the government-run website Safer Federal Workforce, which helped affected organizations put federal COVID rules into place, agencies were told to “take no action to implement or enforce the COVID-19 vaccination requirement” at this time.

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

Doctors’ groups are lining up to support new federal legislation to permanently tie Medicare physician payment updates to inflation.

Introduced by four physician U.S. House representatives, HR 2474 would link Medicare fee schedule updates to the Medicare Economic Index, a measure of inflation related to physicians’ practice costs and wages.

That’s a long-sought goal of the American Medical Association, which is leading 120 state medical societies and medical specialty groups in championing the bill.

The legislation is essential to enabling physician practices to better absorb payment distributions triggered by budget neutrality rules, performance adjustments, and periods of high inflation, the groups wrote in a joint letter sent to the bill’s sponsors. The sponsors say they hope the legislation will improve access to care, as low reimbursements cause some physicians to limit their number of Medicare patients.

Physicians groups for years have urged federal lawmakers to scrap short-term fixes staving off Medicare pay cuts in favor of permanent reforms. Unlike nearly all other Medicare clinicians including hospitals, physicians’ Medicare payment updates aren’t currently tied to inflation.

Adjusted for inflation, Medicare payments to physicians have declined 26% between 2001 and 2023, including a 2% payment reduction in 2023, according to the AMA. Small and rural physician practices have been disproportionately affected by these reductions, as have doctors treating low-income or uninsured patients, the AMA said.

Last month, an influential federal advisory panel recommended permanently tying Medicare physician pay increases to inflation. Clinicians’ cost of providing services, measured by the Medicare Economic Index, rose by 2.6% in 2021 and are estimated to have risen 4.7% in 2022, significantly more than in recent years, the Medicare Payment Advisory Commission said.

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

Doctors’ groups are lining up to support new federal legislation to permanently tie Medicare physician payment updates to inflation.

Introduced by four physician U.S. House representatives, HR 2474 would link Medicare fee schedule updates to the Medicare Economic Index, a measure of inflation related to physicians’ practice costs and wages.

That’s a long-sought goal of the American Medical Association, which is leading 120 state medical societies and medical specialty groups in championing the bill.

The legislation is essential to enabling physician practices to better absorb payment distributions triggered by budget neutrality rules, performance adjustments, and periods of high inflation, the groups wrote in a joint letter sent to the bill’s sponsors. The sponsors say they hope the legislation will improve access to care, as low reimbursements cause some physicians to limit their number of Medicare patients.

Physicians groups for years have urged federal lawmakers to scrap short-term fixes staving off Medicare pay cuts in favor of permanent reforms. Unlike nearly all other Medicare clinicians including hospitals, physicians’ Medicare payment updates aren’t currently tied to inflation.

Adjusted for inflation, Medicare payments to physicians have declined 26% between 2001 and 2023, including a 2% payment reduction in 2023, according to the AMA. Small and rural physician practices have been disproportionately affected by these reductions, as have doctors treating low-income or uninsured patients, the AMA said.

Last month, an influential federal advisory panel recommended permanently tying Medicare physician pay increases to inflation. Clinicians’ cost of providing services, measured by the Medicare Economic Index, rose by 2.6% in 2021 and are estimated to have risen 4.7% in 2022, significantly more than in recent years, the Medicare Payment Advisory Commission said.

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

Doctors’ groups are lining up to support new federal legislation to permanently tie Medicare physician payment updates to inflation.

Introduced by four physician U.S. House representatives, HR 2474 would link Medicare fee schedule updates to the Medicare Economic Index, a measure of inflation related to physicians’ practice costs and wages.

That’s a long-sought goal of the American Medical Association, which is leading 120 state medical societies and medical specialty groups in championing the bill.

The legislation is essential to enabling physician practices to better absorb payment distributions triggered by budget neutrality rules, performance adjustments, and periods of high inflation, the groups wrote in a joint letter sent to the bill’s sponsors. The sponsors say they hope the legislation will improve access to care, as low reimbursements cause some physicians to limit their number of Medicare patients.

Physicians groups for years have urged federal lawmakers to scrap short-term fixes staving off Medicare pay cuts in favor of permanent reforms. Unlike nearly all other Medicare clinicians including hospitals, physicians’ Medicare payment updates aren’t currently tied to inflation.

Adjusted for inflation, Medicare payments to physicians have declined 26% between 2001 and 2023, including a 2% payment reduction in 2023, according to the AMA. Small and rural physician practices have been disproportionately affected by these reductions, as have doctors treating low-income or uninsured patients, the AMA said.

Last month, an influential federal advisory panel recommended permanently tying Medicare physician pay increases to inflation. Clinicians’ cost of providing services, measured by the Medicare Economic Index, rose by 2.6% in 2021 and are estimated to have risen 4.7% in 2022, significantly more than in recent years, the Medicare Payment Advisory Commission said.

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

Medicare is now covering continuous glucose monitoring (CGM) for all beneficiaries with diabetes who use insulin, as well as those with a “history of problematic hypoglycemia.”

The new policy decision, announced earlier this year by the Centers for Medicare and Medicaid Services, means that coverage is expanded to those who take even just a single dose of basal insulin daily or who don’t take insulin but who for other reasons experience “problematic” hypoglycemia, defined as a history of more than one level 2 event (glucose < 54 mg/dL) or at least one level 3 event (< 54 mg/dL requiring assistance).

Previously, coverage was limited to those taking frequent daily insulin doses.  

The additional number of people covered, most with type 2 diabetes, is estimated to be at least 1.5 million. That number could more than double if private insurers follow suit, reported an industry analyst.

Chuck Henderson, chief executive officer of the American Diabetes Association, said in a statement: “We applaud CMS’ decision allowing for all insulin-dependent people as well as others who have a history of problematic hypoglycemia to have access to a continuous glucose monitor, a potentially life-saving tool for diabetes management.”

According to Dexcom, which manufacturers the G6 and the recently approved G7 CGMs, the decision was based in part on their MOBILE study. The trial demonstrated the benefit of CGM in people with type 2 diabetes who use only basal insulin or have a history of problematic hypoglycemic events.

On April 14, Abbott, which manufactures the Freestyle Libre 2 and the recently approved Libre 3, received clearance from the U.S. Food and Drug Administration for the Libre 3’s stand-alone reader device. Previously, the Libre 3 had been approved for use only with a smartphone app. The small handheld reader is considered durable medical equipment, making it eligible for Medicare coverage. Abbott is “working on having the FreeStyle Libre 3 system available to Medicare beneficiaries,” the company said in a statement.

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

Medicare is now covering continuous glucose monitoring (CGM) for all beneficiaries with diabetes who use insulin, as well as those with a “history of problematic hypoglycemia.”

The new policy decision, announced earlier this year by the Centers for Medicare and Medicaid Services, means that coverage is expanded to those who take even just a single dose of basal insulin daily or who don’t take insulin but who for other reasons experience “problematic” hypoglycemia, defined as a history of more than one level 2 event (glucose < 54 mg/dL) or at least one level 3 event (< 54 mg/dL requiring assistance).

Previously, coverage was limited to those taking frequent daily insulin doses.  

The additional number of people covered, most with type 2 diabetes, is estimated to be at least 1.5 million. That number could more than double if private insurers follow suit, reported an industry analyst.

Chuck Henderson, chief executive officer of the American Diabetes Association, said in a statement: “We applaud CMS’ decision allowing for all insulin-dependent people as well as others who have a history of problematic hypoglycemia to have access to a continuous glucose monitor, a potentially life-saving tool for diabetes management.”

According to Dexcom, which manufacturers the G6 and the recently approved G7 CGMs, the decision was based in part on their MOBILE study. The trial demonstrated the benefit of CGM in people with type 2 diabetes who use only basal insulin or have a history of problematic hypoglycemic events.

On April 14, Abbott, which manufactures the Freestyle Libre 2 and the recently approved Libre 3, received clearance from the U.S. Food and Drug Administration for the Libre 3’s stand-alone reader device. Previously, the Libre 3 had been approved for use only with a smartphone app. The small handheld reader is considered durable medical equipment, making it eligible for Medicare coverage. Abbott is “working on having the FreeStyle Libre 3 system available to Medicare beneficiaries,” the company said in a statement.

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

Medicare is now covering continuous glucose monitoring (CGM) for all beneficiaries with diabetes who use insulin, as well as those with a “history of problematic hypoglycemia.”

The new policy decision, announced earlier this year by the Centers for Medicare and Medicaid Services, means that coverage is expanded to those who take even just a single dose of basal insulin daily or who don’t take insulin but who for other reasons experience “problematic” hypoglycemia, defined as a history of more than one level 2 event (glucose < 54 mg/dL) or at least one level 3 event (< 54 mg/dL requiring assistance).

Previously, coverage was limited to those taking frequent daily insulin doses.  

The additional number of people covered, most with type 2 diabetes, is estimated to be at least 1.5 million. That number could more than double if private insurers follow suit, reported an industry analyst.

Chuck Henderson, chief executive officer of the American Diabetes Association, said in a statement: “We applaud CMS’ decision allowing for all insulin-dependent people as well as others who have a history of problematic hypoglycemia to have access to a continuous glucose monitor, a potentially life-saving tool for diabetes management.”

According to Dexcom, which manufacturers the G6 and the recently approved G7 CGMs, the decision was based in part on their MOBILE study. The trial demonstrated the benefit of CGM in people with type 2 diabetes who use only basal insulin or have a history of problematic hypoglycemic events.

On April 14, Abbott, which manufactures the Freestyle Libre 2 and the recently approved Libre 3, received clearance from the U.S. Food and Drug Administration for the Libre 3’s stand-alone reader device. Previously, the Libre 3 had been approved for use only with a smartphone app. The small handheld reader is considered durable medical equipment, making it eligible for Medicare coverage. Abbott is “working on having the FreeStyle Libre 3 system available to Medicare beneficiaries,” the company said in a statement.

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

The Centers for Disease Control and Prevention has updated its COVID-19 booster shot guidelines to clarify that only a single dose of the latest bivalent booster is recommended at this time. 

“If you have completed your updated booster dose, you are currently up to date. There is not a recommendation to get another updated booster dose,” the CDC website  now explains.

In January, the nation’s expert COVID panel recommended that the United States move toward an annual COVID booster shot in the fall, similar to the annual flu shot, that targets the most widely circulating strains of the virus. Recent studies have shown that booster strength wanes after a few months, spurring discussions of whether people at high risk of getting a severe case of COVID may need more than one annual shot.

September was the last time a new booster dose was recommended, when, at the time, the bivalent  booster was released, offering new protection against Omicron variants of the virus. Health officials’ focus is now shifting from preventing infections to reducing the likelihood of severe ones, the San Francisco Chronicle reported.

“The bottom line is that there is some waning of protection for those who got boosters more than six months ago and haven’t had an intervening infection,” said Bob Wachter, MD, head of the University of California–San Francisco’s department of medicine, according to the Chronicle. “But the level of protection versus severe infection continues to be fairly high, good enough that people who aren’t at super high risk are probably fine waiting until a new booster comes out in the fall.”

The Wall Street Journal reported recently that many people have been asking their doctors to give them another booster, which is not authorized by the Food and Drug Administration. 

About 8 in 10 people in the United States got the initial set of COVID-19 vaccines, which were first approved in August 2021. But just 16.4% of people in the United States have gotten the latest booster that was released in September, CDC data show.  

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

The Centers for Disease Control and Prevention has updated its COVID-19 booster shot guidelines to clarify that only a single dose of the latest bivalent booster is recommended at this time. 

“If you have completed your updated booster dose, you are currently up to date. There is not a recommendation to get another updated booster dose,” the CDC website  now explains.

In January, the nation’s expert COVID panel recommended that the United States move toward an annual COVID booster shot in the fall, similar to the annual flu shot, that targets the most widely circulating strains of the virus. Recent studies have shown that booster strength wanes after a few months, spurring discussions of whether people at high risk of getting a severe case of COVID may need more than one annual shot.

September was the last time a new booster dose was recommended, when, at the time, the bivalent  booster was released, offering new protection against Omicron variants of the virus. Health officials’ focus is now shifting from preventing infections to reducing the likelihood of severe ones, the San Francisco Chronicle reported.

“The bottom line is that there is some waning of protection for those who got boosters more than six months ago and haven’t had an intervening infection,” said Bob Wachter, MD, head of the University of California–San Francisco’s department of medicine, according to the Chronicle. “But the level of protection versus severe infection continues to be fairly high, good enough that people who aren’t at super high risk are probably fine waiting until a new booster comes out in the fall.”

The Wall Street Journal reported recently that many people have been asking their doctors to give them another booster, which is not authorized by the Food and Drug Administration. 

About 8 in 10 people in the United States got the initial set of COVID-19 vaccines, which were first approved in August 2021. But just 16.4% of people in the United States have gotten the latest booster that was released in September, CDC data show.  

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

The Centers for Disease Control and Prevention has updated its COVID-19 booster shot guidelines to clarify that only a single dose of the latest bivalent booster is recommended at this time. 

“If you have completed your updated booster dose, you are currently up to date. There is not a recommendation to get another updated booster dose,” the CDC website  now explains.

In January, the nation’s expert COVID panel recommended that the United States move toward an annual COVID booster shot in the fall, similar to the annual flu shot, that targets the most widely circulating strains of the virus. Recent studies have shown that booster strength wanes after a few months, spurring discussions of whether people at high risk of getting a severe case of COVID may need more than one annual shot.

September was the last time a new booster dose was recommended, when, at the time, the bivalent  booster was released, offering new protection against Omicron variants of the virus. Health officials’ focus is now shifting from preventing infections to reducing the likelihood of severe ones, the San Francisco Chronicle reported.

“The bottom line is that there is some waning of protection for those who got boosters more than six months ago and haven’t had an intervening infection,” said Bob Wachter, MD, head of the University of California–San Francisco’s department of medicine, according to the Chronicle. “But the level of protection versus severe infection continues to be fairly high, good enough that people who aren’t at super high risk are probably fine waiting until a new booster comes out in the fall.”

The Wall Street Journal reported recently that many people have been asking their doctors to give them another booster, which is not authorized by the Food and Drug Administration. 

About 8 in 10 people in the United States got the initial set of COVID-19 vaccines, which were first approved in August 2021. But just 16.4% of people in the United States have gotten the latest booster that was released in September, CDC data show.  

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

A former manager at the Philadelphia Veterans Affairs Medical Center (VAMC) has been sentenced to 6 months in federal prison for his part in a bribery scheme.

Ralph Johnson was convicted of accepting $30,000 in kickbacks and bribes for steering contracts to Earron and Carlicha Starks, who ran Ekno Medical Supply and Collondale Medical Supply from 2009 to 2019. Johnson served as chief of environmental services at the medical center. He admitted to receiving cash in binders and packages mailed to his home between 2018 and 2019.

The Starkses pleaded guilty first to paying kickbacks on $7 million worth of contracts to Florida VA facilities, then participated in a sting that implicated Johnson.

The VA Office of Inspector General began investigating Johnson in 2018 after the Starkses, who were indicted for bribing staff at US Department of Veterans Affairs (VA) hospitals in Miami and West Palm Beach, Florida, said they also paid officials in VA facilities on the East Coast.

According to the Philadelphia Inquirer, the judge credited Johnson’s past military service and his “extensive cooperation” with federal authorities investigating fraud within the VA. Johnson apologized to his former employers: “Throughout these 2 and a half years [since the arrest] there’s not a day I don’t think about the wrongness that I did.”

In addition to the prison sentence, Johnson has been ordered to pay back, at $50 a month, the $440,000-plus he cost the Philadelphia VAMC in fraudulent and bloated contracts.

Johnson is at least the third Philadelphia VAMC employee indicted or sentenced for fraud since 2020.

A former manager at the Philadelphia Veterans Affairs Medical Center (VAMC) has been sentenced to 6 months in federal prison for his part in a bribery scheme.

Ralph Johnson was convicted of accepting $30,000 in kickbacks and bribes for steering contracts to Earron and Carlicha Starks, who ran Ekno Medical Supply and Collondale Medical Supply from 2009 to 2019. Johnson served as chief of environmental services at the medical center. He admitted to receiving cash in binders and packages mailed to his home between 2018 and 2019.

The Starkses pleaded guilty first to paying kickbacks on $7 million worth of contracts to Florida VA facilities, then participated in a sting that implicated Johnson.

The VA Office of Inspector General began investigating Johnson in 2018 after the Starkses, who were indicted for bribing staff at US Department of Veterans Affairs (VA) hospitals in Miami and West Palm Beach, Florida, said they also paid officials in VA facilities on the East Coast.

According to the Philadelphia Inquirer, the judge credited Johnson’s past military service and his “extensive cooperation” with federal authorities investigating fraud within the VA. Johnson apologized to his former employers: “Throughout these 2 and a half years [since the arrest] there’s not a day I don’t think about the wrongness that I did.”

In addition to the prison sentence, Johnson has been ordered to pay back, at $50 a month, the $440,000-plus he cost the Philadelphia VAMC in fraudulent and bloated contracts.

Johnson is at least the third Philadelphia VAMC employee indicted or sentenced for fraud since 2020.

A former manager at the Philadelphia Veterans Affairs Medical Center (VAMC) has been sentenced to 6 months in federal prison for his part in a bribery scheme.

Ralph Johnson was convicted of accepting $30,000 in kickbacks and bribes for steering contracts to Earron and Carlicha Starks, who ran Ekno Medical Supply and Collondale Medical Supply from 2009 to 2019. Johnson served as chief of environmental services at the medical center. He admitted to receiving cash in binders and packages mailed to his home between 2018 and 2019.

The Starkses pleaded guilty first to paying kickbacks on $7 million worth of contracts to Florida VA facilities, then participated in a sting that implicated Johnson.

The VA Office of Inspector General began investigating Johnson in 2018 after the Starkses, who were indicted for bribing staff at US Department of Veterans Affairs (VA) hospitals in Miami and West Palm Beach, Florida, said they also paid officials in VA facilities on the East Coast.

According to the Philadelphia Inquirer, the judge credited Johnson’s past military service and his “extensive cooperation” with federal authorities investigating fraud within the VA. Johnson apologized to his former employers: “Throughout these 2 and a half years [since the arrest] there’s not a day I don’t think about the wrongness that I did.”

In addition to the prison sentence, Johnson has been ordered to pay back, at $50 a month, the $440,000-plus he cost the Philadelphia VAMC in fraudulent and bloated contracts.

Johnson is at least the third Philadelphia VAMC employee indicted or sentenced for fraud since 2020.