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No increase seen in children’s cumulative COVID-19 burden
Children’s share of the cumulative COVID-19 burden remained at 12.4% for a second consecutive week, the AAP and CHA said in their weekly report. The last full week of 2020 also marked the second consecutive drop in new cases, although that may be holiday related.
There were almost 128,000 new cases of COVID-19 reported in children for the week, down from 179,000 cases the week before (Dec. 24) and down from the pandemic high of 182,000 reported 2 weeks earlier (Dec.17), based on data from 49 state health departments (excluding New York), along with the District of Columbia, New York City, Puerto Rico, and Guam.
Children’s proportion of new cases for the week, 12.6%, is at its lowest point since early October after dropping for the second week in a row. The cumulative rate of COVID-19 infection, however, is now 2,828 cases per 100,000 children, up from 2,658 the previous week, the AAP and CHA said.
State-level metrics show that North Dakota has the highest cumulative rate at 7,851 per 100,000 children and Hawaii the lowest at 828. Wyoming’s cumulative proportion of child cases, 20.3%, is the highest in the country, while Florida, which uses an age range of 0-14 years for children, is the lowest at 7.1%. California’s total of 268,000 cases is almost double the number of second-place Illinois (138,000), the AAP/CHA data show.
Cumulative child deaths from COVID-19 are up to 179 in the jurisdictions reporting such data (43 states and New York City). That represents just 0.6% of all coronavirus-related deaths and has changed little over the last several months – never rising higher than 0.7% or dropping below 0.6% since early July, according to the report.
Children’s share of the cumulative COVID-19 burden remained at 12.4% for a second consecutive week, the AAP and CHA said in their weekly report. The last full week of 2020 also marked the second consecutive drop in new cases, although that may be holiday related.
There were almost 128,000 new cases of COVID-19 reported in children for the week, down from 179,000 cases the week before (Dec. 24) and down from the pandemic high of 182,000 reported 2 weeks earlier (Dec.17), based on data from 49 state health departments (excluding New York), along with the District of Columbia, New York City, Puerto Rico, and Guam.
Children’s proportion of new cases for the week, 12.6%, is at its lowest point since early October after dropping for the second week in a row. The cumulative rate of COVID-19 infection, however, is now 2,828 cases per 100,000 children, up from 2,658 the previous week, the AAP and CHA said.
State-level metrics show that North Dakota has the highest cumulative rate at 7,851 per 100,000 children and Hawaii the lowest at 828. Wyoming’s cumulative proportion of child cases, 20.3%, is the highest in the country, while Florida, which uses an age range of 0-14 years for children, is the lowest at 7.1%. California’s total of 268,000 cases is almost double the number of second-place Illinois (138,000), the AAP/CHA data show.
Cumulative child deaths from COVID-19 are up to 179 in the jurisdictions reporting such data (43 states and New York City). That represents just 0.6% of all coronavirus-related deaths and has changed little over the last several months – never rising higher than 0.7% or dropping below 0.6% since early July, according to the report.
Children’s share of the cumulative COVID-19 burden remained at 12.4% for a second consecutive week, the AAP and CHA said in their weekly report. The last full week of 2020 also marked the second consecutive drop in new cases, although that may be holiday related.
There were almost 128,000 new cases of COVID-19 reported in children for the week, down from 179,000 cases the week before (Dec. 24) and down from the pandemic high of 182,000 reported 2 weeks earlier (Dec.17), based on data from 49 state health departments (excluding New York), along with the District of Columbia, New York City, Puerto Rico, and Guam.
Children’s proportion of new cases for the week, 12.6%, is at its lowest point since early October after dropping for the second week in a row. The cumulative rate of COVID-19 infection, however, is now 2,828 cases per 100,000 children, up from 2,658 the previous week, the AAP and CHA said.
State-level metrics show that North Dakota has the highest cumulative rate at 7,851 per 100,000 children and Hawaii the lowest at 828. Wyoming’s cumulative proportion of child cases, 20.3%, is the highest in the country, while Florida, which uses an age range of 0-14 years for children, is the lowest at 7.1%. California’s total of 268,000 cases is almost double the number of second-place Illinois (138,000), the AAP/CHA data show.
Cumulative child deaths from COVID-19 are up to 179 in the jurisdictions reporting such data (43 states and New York City). That represents just 0.6% of all coronavirus-related deaths and has changed little over the last several months – never rising higher than 0.7% or dropping below 0.6% since early July, according to the report.
Many health plans now must cover full cost of expensive HIV prevention drugs
Ted Howard started taking Truvada a few years ago because he wanted to protect himself against HIV, the virus that causes AIDS. But the daily pill was so pricey he was seriously thinking about giving it up.
Under his insurance plan, the former flight attendant and customer service instructor owed $500 in copayments every month for the drug and an additional $250 every three months for lab work and clinic visits.
Luckily for Howard, his doctor at Las Vegas’ Huntridge Family Clinic, which specializes in LGBTQ care, enrolled him in a clinical trial that covered his medication and other costs in full.
“If I hadn’t been able to get into the trial, I wouldn’t have kept taking PrEP,” said Howard, 68, using the shorthand term for “preexposure prophylaxis.” Taken daily, these drugs — like Truvada — are more than 90% effective at preventing infection with HIV.
(some plans already began doing so last year).
Drugs in this category — Truvada, Descovy and, newly available, a generic version of Truvada — received an “A” recommendation by the U.S. Preventive Services Task Force. Under the Affordable Care Act, preventive services that receive an “A” or “B” rating by the task force, a group of medical experts in prevention and primary care, must be covered by most private health plans without making members share the cost, usually through copayments or deductibles. Only plans that are grandfathered under the health law are exempt.
The task force recommended PrEP for people at high risk of HIV infection, including men who have sex with men and injection drug users.
In the United States, more than 1 million people live with HIV, and nearly 40,000 new HIV cases are diagnosed every year. Yet fewer than 10% of people who could benefit from PrEP are taking it. One key reason is that out-of-pocket costs can exceed $1,000 annually, according to a study published in the American Journal of Public Health last year. Required periodic blood tests and doctor visits can add hundreds of dollars to the cost of the drug, and it’s not clear if insurers are required to pick up all those costs.
“Cost sharing has been a problem,” said Michael Crews, policy director at One Colorado, an advocacy group for the LGBTQ community. “It’s not just getting on PrEP and taking a pill. It’s the lab and clinical services. That’s a huge barrier for folks.”
Whether you’re shopping for a new plan during open enrollment or want to check out what your current plan covers, here are answers to questions you may have about the new preventive coverage requirement.
Q: How can people find out whether their health plan covers PrEP medications without charge?
The plan’s list of covered drugs, called a formulary, should spell out which drugs are covered, along with details about which drug tier they fall into. Drugs placed in higher tiers generally have higher cost sharing. That list should be online with the plan documents that give coverage details.
Sorting out coverage and cost sharing can be tricky. Both Truvada and Descovy can also be used to treat HIV, and if they are taken for that purpose, a plan may require members to pay some of the cost. But if the drugs are taken to prevent HIV infection, patients shouldn’t owe anything out-of-pocket, no matter which tier they are on.
In a recent analysis of online formularies for plans sold on the ACA marketplaces, Carl Schmid, executive director of the HIV + Hepatitis Policy Institute, found that many plans seemed out of compliance with the requirement to cover PrEP without cost sharing this year.
But representatives for Oscar and Kaiser Permanente, two insurers that were called out in the analysis for lack of compliance, said the drugs are covered without cost sharing in plans nationwide if they are taken to prevent HIV. Schmid later revised his analysis to reflect Oscar’s coverage.
Coverage and cost-sharing information needs to be transparent and easy to find, Schmid said.
“I acted like a shopper of insurance, just like any person would do,” he said. “Even when the information is correct, [it’s so] difficult to find [and there’s] no uniformity.”
It may be necessary to call the insurer directly to confirm coverage details if information on the website is unclear.
Q: Are all three drugs covered without cost sharing?
Health plans have to cover at least one of the drugs in this category — Descovy and the brand and generic versions of Truvada — without cost sharing. People may have to jump through some hoops to get approval for a specific drug, however. For example, Oscar plans sold in 18 states cover the three PrEP options without cost sharing. The generic version of Truvada doesn’t require prior authorization by the insurer. But if someone wants to take the name-brand drug, that person has to go through an approval process. Descovy, a newer drug, is available without cost sharing only if people are unable to use Truvada or its generic version because of clinical intolerance or other issues.
Q: What about the lab work and clinical visits that are necessary while taking PrEP? Are those services also covered without cost sharing?
That is the thousand-dollar question. People who are taking drugs to prevent HIV infection need to meet with a clinician and have blood work every three months to test for HIV, hepatitis B and sexually transmitted infections, and to check their kidney function.
The task force recommendation doesn’t specify whether these services must also be covered without cost sharing, and advocates say federal guidance is necessary to ensure they are free.
“If you’ve got a high-deductible plan and you’ve got to meet it before those services are covered, that’s going to add up,” said Amy Killelea, senior director of health systems and policy at the National Alliance of State & Territorial AIDS Directors. “We’re trying to emphasize that it’s integral to the intervention itself.”
A handful of states have programs that help people cover their out-of-pocket costs for lab and clinical visits, generally based on income.
There is precedent for including free ancillary care as part of a recommended preventive service. After consumers and advocates complained, the Centers for Medicare & Medicaid Services (CMS) clarified that under the ACA removing a polyp during a screening colonoscopy is considered an integral part of the procedure and patients shouldn’t be charged for it.
CMS officials declined to clarify whether PrEP services such as lab work and clinical visits are to be covered without cost sharing as part of the preventive service and noted that states generally enforce such insurance requirements. “CMS intends to contact state regulators, as appropriate, to discuss issuer’s compliance with the federal requirements and whether issuers need further guidance on which services associated with PrEP must be covered without cost sharing,” the agency said in a statement.
Q: What if someone runs into roadblocks getting a plan to cover PrEP or related services without cost sharing?
If an insurer charges for the medication or a follow-up visit, people may have to go through an appeals process to fight it.
“They’d have to appeal to the insurance company and then to the state if they don’t succeed,” said Nadeen Israel, vice president of policy and advocacy at the AIDS Foundation of Chicago. “Most people don’t know to do that.”
Q: Are uninsured people also protected by this new cost-sharing change for PrEP?
Unfortunately, no. The ACA requirement to cover recommended preventive services without charging patients applies only to private insurance plans. People without insurance don’t benefit. Gilead, which makes both Truvada and Descovy, has a patient assistance program for the uninsured.
Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of Kaiser Family Foundation, which is not affiliated with Kaiser Permanente.
Ted Howard started taking Truvada a few years ago because he wanted to protect himself against HIV, the virus that causes AIDS. But the daily pill was so pricey he was seriously thinking about giving it up.
Under his insurance plan, the former flight attendant and customer service instructor owed $500 in copayments every month for the drug and an additional $250 every three months for lab work and clinic visits.
Luckily for Howard, his doctor at Las Vegas’ Huntridge Family Clinic, which specializes in LGBTQ care, enrolled him in a clinical trial that covered his medication and other costs in full.
“If I hadn’t been able to get into the trial, I wouldn’t have kept taking PrEP,” said Howard, 68, using the shorthand term for “preexposure prophylaxis.” Taken daily, these drugs — like Truvada — are more than 90% effective at preventing infection with HIV.
(some plans already began doing so last year).
Drugs in this category — Truvada, Descovy and, newly available, a generic version of Truvada — received an “A” recommendation by the U.S. Preventive Services Task Force. Under the Affordable Care Act, preventive services that receive an “A” or “B” rating by the task force, a group of medical experts in prevention and primary care, must be covered by most private health plans without making members share the cost, usually through copayments or deductibles. Only plans that are grandfathered under the health law are exempt.
The task force recommended PrEP for people at high risk of HIV infection, including men who have sex with men and injection drug users.
In the United States, more than 1 million people live with HIV, and nearly 40,000 new HIV cases are diagnosed every year. Yet fewer than 10% of people who could benefit from PrEP are taking it. One key reason is that out-of-pocket costs can exceed $1,000 annually, according to a study published in the American Journal of Public Health last year. Required periodic blood tests and doctor visits can add hundreds of dollars to the cost of the drug, and it’s not clear if insurers are required to pick up all those costs.
“Cost sharing has been a problem,” said Michael Crews, policy director at One Colorado, an advocacy group for the LGBTQ community. “It’s not just getting on PrEP and taking a pill. It’s the lab and clinical services. That’s a huge barrier for folks.”
Whether you’re shopping for a new plan during open enrollment or want to check out what your current plan covers, here are answers to questions you may have about the new preventive coverage requirement.
Q: How can people find out whether their health plan covers PrEP medications without charge?
The plan’s list of covered drugs, called a formulary, should spell out which drugs are covered, along with details about which drug tier they fall into. Drugs placed in higher tiers generally have higher cost sharing. That list should be online with the plan documents that give coverage details.
Sorting out coverage and cost sharing can be tricky. Both Truvada and Descovy can also be used to treat HIV, and if they are taken for that purpose, a plan may require members to pay some of the cost. But if the drugs are taken to prevent HIV infection, patients shouldn’t owe anything out-of-pocket, no matter which tier they are on.
In a recent analysis of online formularies for plans sold on the ACA marketplaces, Carl Schmid, executive director of the HIV + Hepatitis Policy Institute, found that many plans seemed out of compliance with the requirement to cover PrEP without cost sharing this year.
But representatives for Oscar and Kaiser Permanente, two insurers that were called out in the analysis for lack of compliance, said the drugs are covered without cost sharing in plans nationwide if they are taken to prevent HIV. Schmid later revised his analysis to reflect Oscar’s coverage.
Coverage and cost-sharing information needs to be transparent and easy to find, Schmid said.
“I acted like a shopper of insurance, just like any person would do,” he said. “Even when the information is correct, [it’s so] difficult to find [and there’s] no uniformity.”
It may be necessary to call the insurer directly to confirm coverage details if information on the website is unclear.
Q: Are all three drugs covered without cost sharing?
Health plans have to cover at least one of the drugs in this category — Descovy and the brand and generic versions of Truvada — without cost sharing. People may have to jump through some hoops to get approval for a specific drug, however. For example, Oscar plans sold in 18 states cover the three PrEP options without cost sharing. The generic version of Truvada doesn’t require prior authorization by the insurer. But if someone wants to take the name-brand drug, that person has to go through an approval process. Descovy, a newer drug, is available without cost sharing only if people are unable to use Truvada or its generic version because of clinical intolerance or other issues.
Q: What about the lab work and clinical visits that are necessary while taking PrEP? Are those services also covered without cost sharing?
That is the thousand-dollar question. People who are taking drugs to prevent HIV infection need to meet with a clinician and have blood work every three months to test for HIV, hepatitis B and sexually transmitted infections, and to check their kidney function.
The task force recommendation doesn’t specify whether these services must also be covered without cost sharing, and advocates say federal guidance is necessary to ensure they are free.
“If you’ve got a high-deductible plan and you’ve got to meet it before those services are covered, that’s going to add up,” said Amy Killelea, senior director of health systems and policy at the National Alliance of State & Territorial AIDS Directors. “We’re trying to emphasize that it’s integral to the intervention itself.”
A handful of states have programs that help people cover their out-of-pocket costs for lab and clinical visits, generally based on income.
There is precedent for including free ancillary care as part of a recommended preventive service. After consumers and advocates complained, the Centers for Medicare & Medicaid Services (CMS) clarified that under the ACA removing a polyp during a screening colonoscopy is considered an integral part of the procedure and patients shouldn’t be charged for it.
CMS officials declined to clarify whether PrEP services such as lab work and clinical visits are to be covered without cost sharing as part of the preventive service and noted that states generally enforce such insurance requirements. “CMS intends to contact state regulators, as appropriate, to discuss issuer’s compliance with the federal requirements and whether issuers need further guidance on which services associated with PrEP must be covered without cost sharing,” the agency said in a statement.
Q: What if someone runs into roadblocks getting a plan to cover PrEP or related services without cost sharing?
If an insurer charges for the medication or a follow-up visit, people may have to go through an appeals process to fight it.
“They’d have to appeal to the insurance company and then to the state if they don’t succeed,” said Nadeen Israel, vice president of policy and advocacy at the AIDS Foundation of Chicago. “Most people don’t know to do that.”
Q: Are uninsured people also protected by this new cost-sharing change for PrEP?
Unfortunately, no. The ACA requirement to cover recommended preventive services without charging patients applies only to private insurance plans. People without insurance don’t benefit. Gilead, which makes both Truvada and Descovy, has a patient assistance program for the uninsured.
Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of Kaiser Family Foundation, which is not affiliated with Kaiser Permanente.
Ted Howard started taking Truvada a few years ago because he wanted to protect himself against HIV, the virus that causes AIDS. But the daily pill was so pricey he was seriously thinking about giving it up.
Under his insurance plan, the former flight attendant and customer service instructor owed $500 in copayments every month for the drug and an additional $250 every three months for lab work and clinic visits.
Luckily for Howard, his doctor at Las Vegas’ Huntridge Family Clinic, which specializes in LGBTQ care, enrolled him in a clinical trial that covered his medication and other costs in full.
“If I hadn’t been able to get into the trial, I wouldn’t have kept taking PrEP,” said Howard, 68, using the shorthand term for “preexposure prophylaxis.” Taken daily, these drugs — like Truvada — are more than 90% effective at preventing infection with HIV.
(some plans already began doing so last year).
Drugs in this category — Truvada, Descovy and, newly available, a generic version of Truvada — received an “A” recommendation by the U.S. Preventive Services Task Force. Under the Affordable Care Act, preventive services that receive an “A” or “B” rating by the task force, a group of medical experts in prevention and primary care, must be covered by most private health plans without making members share the cost, usually through copayments or deductibles. Only plans that are grandfathered under the health law are exempt.
The task force recommended PrEP for people at high risk of HIV infection, including men who have sex with men and injection drug users.
In the United States, more than 1 million people live with HIV, and nearly 40,000 new HIV cases are diagnosed every year. Yet fewer than 10% of people who could benefit from PrEP are taking it. One key reason is that out-of-pocket costs can exceed $1,000 annually, according to a study published in the American Journal of Public Health last year. Required periodic blood tests and doctor visits can add hundreds of dollars to the cost of the drug, and it’s not clear if insurers are required to pick up all those costs.
“Cost sharing has been a problem,” said Michael Crews, policy director at One Colorado, an advocacy group for the LGBTQ community. “It’s not just getting on PrEP and taking a pill. It’s the lab and clinical services. That’s a huge barrier for folks.”
Whether you’re shopping for a new plan during open enrollment or want to check out what your current plan covers, here are answers to questions you may have about the new preventive coverage requirement.
Q: How can people find out whether their health plan covers PrEP medications without charge?
The plan’s list of covered drugs, called a formulary, should spell out which drugs are covered, along with details about which drug tier they fall into. Drugs placed in higher tiers generally have higher cost sharing. That list should be online with the plan documents that give coverage details.
Sorting out coverage and cost sharing can be tricky. Both Truvada and Descovy can also be used to treat HIV, and if they are taken for that purpose, a plan may require members to pay some of the cost. But if the drugs are taken to prevent HIV infection, patients shouldn’t owe anything out-of-pocket, no matter which tier they are on.
In a recent analysis of online formularies for plans sold on the ACA marketplaces, Carl Schmid, executive director of the HIV + Hepatitis Policy Institute, found that many plans seemed out of compliance with the requirement to cover PrEP without cost sharing this year.
But representatives for Oscar and Kaiser Permanente, two insurers that were called out in the analysis for lack of compliance, said the drugs are covered without cost sharing in plans nationwide if they are taken to prevent HIV. Schmid later revised his analysis to reflect Oscar’s coverage.
Coverage and cost-sharing information needs to be transparent and easy to find, Schmid said.
“I acted like a shopper of insurance, just like any person would do,” he said. “Even when the information is correct, [it’s so] difficult to find [and there’s] no uniformity.”
It may be necessary to call the insurer directly to confirm coverage details if information on the website is unclear.
Q: Are all three drugs covered without cost sharing?
Health plans have to cover at least one of the drugs in this category — Descovy and the brand and generic versions of Truvada — without cost sharing. People may have to jump through some hoops to get approval for a specific drug, however. For example, Oscar plans sold in 18 states cover the three PrEP options without cost sharing. The generic version of Truvada doesn’t require prior authorization by the insurer. But if someone wants to take the name-brand drug, that person has to go through an approval process. Descovy, a newer drug, is available without cost sharing only if people are unable to use Truvada or its generic version because of clinical intolerance or other issues.
Q: What about the lab work and clinical visits that are necessary while taking PrEP? Are those services also covered without cost sharing?
That is the thousand-dollar question. People who are taking drugs to prevent HIV infection need to meet with a clinician and have blood work every three months to test for HIV, hepatitis B and sexually transmitted infections, and to check their kidney function.
The task force recommendation doesn’t specify whether these services must also be covered without cost sharing, and advocates say federal guidance is necessary to ensure they are free.
“If you’ve got a high-deductible plan and you’ve got to meet it before those services are covered, that’s going to add up,” said Amy Killelea, senior director of health systems and policy at the National Alliance of State & Territorial AIDS Directors. “We’re trying to emphasize that it’s integral to the intervention itself.”
A handful of states have programs that help people cover their out-of-pocket costs for lab and clinical visits, generally based on income.
There is precedent for including free ancillary care as part of a recommended preventive service. After consumers and advocates complained, the Centers for Medicare & Medicaid Services (CMS) clarified that under the ACA removing a polyp during a screening colonoscopy is considered an integral part of the procedure and patients shouldn’t be charged for it.
CMS officials declined to clarify whether PrEP services such as lab work and clinical visits are to be covered without cost sharing as part of the preventive service and noted that states generally enforce such insurance requirements. “CMS intends to contact state regulators, as appropriate, to discuss issuer’s compliance with the federal requirements and whether issuers need further guidance on which services associated with PrEP must be covered without cost sharing,” the agency said in a statement.
Q: What if someone runs into roadblocks getting a plan to cover PrEP or related services without cost sharing?
If an insurer charges for the medication or a follow-up visit, people may have to go through an appeals process to fight it.
“They’d have to appeal to the insurance company and then to the state if they don’t succeed,” said Nadeen Israel, vice president of policy and advocacy at the AIDS Foundation of Chicago. “Most people don’t know to do that.”
Q: Are uninsured people also protected by this new cost-sharing change for PrEP?
Unfortunately, no. The ACA requirement to cover recommended preventive services without charging patients applies only to private insurance plans. People without insurance don’t benefit. Gilead, which makes both Truvada and Descovy, has a patient assistance program for the uninsured.
Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of Kaiser Family Foundation, which is not affiliated with Kaiser Permanente.
Experts debate wisdom of delaying second COVID-19 vaccine dose
A proposal to delay administration of the second dose of COVID-19 vaccines – suggested as a strategy to boost the number of people who get some degree of protection from a single immunization with the Pfizer/BioNTech or Moderna vaccines – is inciting a strong debate among clinicians and public health officials.
Opponents raise concerns about diverting from the two-dose schedule evaluated in clinical trials, including a lack of data on long-term protection from a single dose. They also suggest a longer interval between dosing could increase resistance of SARS-CoV-2 virus.
It is time to consider delaying the second dose, Robert M. Wachter, MD, at the University of California San Francisco, and Ashish Jha, MD, MPH, at Brown University in Providence, R.I., wrote in an opinion piece in The Washington Post Jan. 3.
The two experts state that supply constraints, distribution bottlenecks, and hundreds of thousands of new infections daily prompted them to change their stance on administering COVID-19 vaccines according to the two-dose clinical trial regimen. Furthermore, they cited a study in the New England Journal of Medicine that suggests 80%-90% efficacy for preventing SARS-CoV-2 infection following one dose of the Moderna vaccine.
Not everyone agrees one dose is a good idea. “Clinical trials with specific schedules for vaccine dosing – that’s the whole basis of the scientific evidence,” Maria Elena Bottazzi, PhD, associate dean of the National School of Tropical Medicine at Baylor College of Medicine in Houston, said in an interview.
After one dose “the immune system is learning, but it’s not ideal. That’s why you need the second dose,” Dr. Bottazzi said. “I appreciate the urgency and the anxiety ... but the data support [that] clinical efficacy requires two doses.”
Another proposed strategy to extend the current supply of COVID-19 vaccines to more Americans involves splitting the current dosage of the Moderna vaccine in half. Officials in the United States and the United Kingdom are reportedly considering this approach. In the United States, the Food and Drug Administration would have to approve any dosing change.
Agreeing to disagree
Dr. Wachter shared a link to his opinion piece on Twitter, stating that “We both came to this view because of the slow rollout & the new variant. But it’s a tough call and reasonable people will disagree.”
As predicted, the tweet elicited a number of strong opinions.
“There are no correct answers but there’s data deficiency, plenty of fodder and need for healthy, intellectual debate. That wouldn’t be occurring if there was an ample supply of vaccines,” Eric Topol, MD, director of the Scripps Translational Science Institute and editor-in-chief of Medscape, tweeted on Jan. 3.
“If the problem were with the supply of the vaccine, one might make an argument for focusing on 1st dose. But the problem is in distribution of the vaccine & giving actual doses,” John Grohol, PsyD, tweeted.
“Right now we don’t have a supply issue, we have a distribution issue,” Angela Shen, ScD, MPH, a research scientist in the Vaccine Education Center at Children’s Hospital of Philadelphia, said in an interview. Emergency use authorization for the Johnson & Johnson and other COVID-19 vaccines in development could further boost available supplies, she added.
“The clinical trials studied two doses,” Dr. Shen said. “We don’t have data that one dose is going to have lasting protection.”
Does new variant change equation?
Dr. Wachter and Dr. Jha, in their editorial, cited a quote from former boxing champion Mike Tyson: “Everybody has a plan until they’ve been punched in the mouth.” ‘Punches’ such as the new variant, the high number of cases and deaths in the United States, and other problems prompted them to advocate for the delayed dosing strategy.
“Appreciate the concern for the new variant – I think it’s worth noting that we’re punching ourselves in the mouth with the slow vaccine rollout, which is the first problem to solve,” Jake Quinton, MD, an internist at UCLA Health in Los Angeles, noted on Twitter.
Vaccine and public resistance raised
“I agree with the problem but not with the proposed solution, which is guesswork not based on data,” the Jan Grimm Lab at Memorial Sloan Kettering Cancer Center in New York responded to Dr. Wachter and Dr. Jha on Twitter. “There ARE data though that show that 1 shot alone did not elicit sufficient T-cell nor antibody response. This might also lead to mutations resistant to the vaccines. Dangerous!”
Other physicians took to Twitter to point out that changing the recommendations at this point could further erode public confidence in COVID-19 immunization. For example, Deirdre Habermehl, MD, wrote, “We’ve spent months telling the public the best route is to follow the science and now without data think a course correction based on a guesstimate is ok? Public confidence is low enough and the real issue is logistics at this point.”
Dr. Shen and Dr. Bottazzi have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A proposal to delay administration of the second dose of COVID-19 vaccines – suggested as a strategy to boost the number of people who get some degree of protection from a single immunization with the Pfizer/BioNTech or Moderna vaccines – is inciting a strong debate among clinicians and public health officials.
Opponents raise concerns about diverting from the two-dose schedule evaluated in clinical trials, including a lack of data on long-term protection from a single dose. They also suggest a longer interval between dosing could increase resistance of SARS-CoV-2 virus.
It is time to consider delaying the second dose, Robert M. Wachter, MD, at the University of California San Francisco, and Ashish Jha, MD, MPH, at Brown University in Providence, R.I., wrote in an opinion piece in The Washington Post Jan. 3.
The two experts state that supply constraints, distribution bottlenecks, and hundreds of thousands of new infections daily prompted them to change their stance on administering COVID-19 vaccines according to the two-dose clinical trial regimen. Furthermore, they cited a study in the New England Journal of Medicine that suggests 80%-90% efficacy for preventing SARS-CoV-2 infection following one dose of the Moderna vaccine.
Not everyone agrees one dose is a good idea. “Clinical trials with specific schedules for vaccine dosing – that’s the whole basis of the scientific evidence,” Maria Elena Bottazzi, PhD, associate dean of the National School of Tropical Medicine at Baylor College of Medicine in Houston, said in an interview.
After one dose “the immune system is learning, but it’s not ideal. That’s why you need the second dose,” Dr. Bottazzi said. “I appreciate the urgency and the anxiety ... but the data support [that] clinical efficacy requires two doses.”
Another proposed strategy to extend the current supply of COVID-19 vaccines to more Americans involves splitting the current dosage of the Moderna vaccine in half. Officials in the United States and the United Kingdom are reportedly considering this approach. In the United States, the Food and Drug Administration would have to approve any dosing change.
Agreeing to disagree
Dr. Wachter shared a link to his opinion piece on Twitter, stating that “We both came to this view because of the slow rollout & the new variant. But it’s a tough call and reasonable people will disagree.”
As predicted, the tweet elicited a number of strong opinions.
“There are no correct answers but there’s data deficiency, plenty of fodder and need for healthy, intellectual debate. That wouldn’t be occurring if there was an ample supply of vaccines,” Eric Topol, MD, director of the Scripps Translational Science Institute and editor-in-chief of Medscape, tweeted on Jan. 3.
“If the problem were with the supply of the vaccine, one might make an argument for focusing on 1st dose. But the problem is in distribution of the vaccine & giving actual doses,” John Grohol, PsyD, tweeted.
“Right now we don’t have a supply issue, we have a distribution issue,” Angela Shen, ScD, MPH, a research scientist in the Vaccine Education Center at Children’s Hospital of Philadelphia, said in an interview. Emergency use authorization for the Johnson & Johnson and other COVID-19 vaccines in development could further boost available supplies, she added.
“The clinical trials studied two doses,” Dr. Shen said. “We don’t have data that one dose is going to have lasting protection.”
Does new variant change equation?
Dr. Wachter and Dr. Jha, in their editorial, cited a quote from former boxing champion Mike Tyson: “Everybody has a plan until they’ve been punched in the mouth.” ‘Punches’ such as the new variant, the high number of cases and deaths in the United States, and other problems prompted them to advocate for the delayed dosing strategy.
“Appreciate the concern for the new variant – I think it’s worth noting that we’re punching ourselves in the mouth with the slow vaccine rollout, which is the first problem to solve,” Jake Quinton, MD, an internist at UCLA Health in Los Angeles, noted on Twitter.
Vaccine and public resistance raised
“I agree with the problem but not with the proposed solution, which is guesswork not based on data,” the Jan Grimm Lab at Memorial Sloan Kettering Cancer Center in New York responded to Dr. Wachter and Dr. Jha on Twitter. “There ARE data though that show that 1 shot alone did not elicit sufficient T-cell nor antibody response. This might also lead to mutations resistant to the vaccines. Dangerous!”
Other physicians took to Twitter to point out that changing the recommendations at this point could further erode public confidence in COVID-19 immunization. For example, Deirdre Habermehl, MD, wrote, “We’ve spent months telling the public the best route is to follow the science and now without data think a course correction based on a guesstimate is ok? Public confidence is low enough and the real issue is logistics at this point.”
Dr. Shen and Dr. Bottazzi have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A proposal to delay administration of the second dose of COVID-19 vaccines – suggested as a strategy to boost the number of people who get some degree of protection from a single immunization with the Pfizer/BioNTech or Moderna vaccines – is inciting a strong debate among clinicians and public health officials.
Opponents raise concerns about diverting from the two-dose schedule evaluated in clinical trials, including a lack of data on long-term protection from a single dose. They also suggest a longer interval between dosing could increase resistance of SARS-CoV-2 virus.
It is time to consider delaying the second dose, Robert M. Wachter, MD, at the University of California San Francisco, and Ashish Jha, MD, MPH, at Brown University in Providence, R.I., wrote in an opinion piece in The Washington Post Jan. 3.
The two experts state that supply constraints, distribution bottlenecks, and hundreds of thousands of new infections daily prompted them to change their stance on administering COVID-19 vaccines according to the two-dose clinical trial regimen. Furthermore, they cited a study in the New England Journal of Medicine that suggests 80%-90% efficacy for preventing SARS-CoV-2 infection following one dose of the Moderna vaccine.
Not everyone agrees one dose is a good idea. “Clinical trials with specific schedules for vaccine dosing – that’s the whole basis of the scientific evidence,” Maria Elena Bottazzi, PhD, associate dean of the National School of Tropical Medicine at Baylor College of Medicine in Houston, said in an interview.
After one dose “the immune system is learning, but it’s not ideal. That’s why you need the second dose,” Dr. Bottazzi said. “I appreciate the urgency and the anxiety ... but the data support [that] clinical efficacy requires two doses.”
Another proposed strategy to extend the current supply of COVID-19 vaccines to more Americans involves splitting the current dosage of the Moderna vaccine in half. Officials in the United States and the United Kingdom are reportedly considering this approach. In the United States, the Food and Drug Administration would have to approve any dosing change.
Agreeing to disagree
Dr. Wachter shared a link to his opinion piece on Twitter, stating that “We both came to this view because of the slow rollout & the new variant. But it’s a tough call and reasonable people will disagree.”
As predicted, the tweet elicited a number of strong opinions.
“There are no correct answers but there’s data deficiency, plenty of fodder and need for healthy, intellectual debate. That wouldn’t be occurring if there was an ample supply of vaccines,” Eric Topol, MD, director of the Scripps Translational Science Institute and editor-in-chief of Medscape, tweeted on Jan. 3.
“If the problem were with the supply of the vaccine, one might make an argument for focusing on 1st dose. But the problem is in distribution of the vaccine & giving actual doses,” John Grohol, PsyD, tweeted.
“Right now we don’t have a supply issue, we have a distribution issue,” Angela Shen, ScD, MPH, a research scientist in the Vaccine Education Center at Children’s Hospital of Philadelphia, said in an interview. Emergency use authorization for the Johnson & Johnson and other COVID-19 vaccines in development could further boost available supplies, she added.
“The clinical trials studied two doses,” Dr. Shen said. “We don’t have data that one dose is going to have lasting protection.”
Does new variant change equation?
Dr. Wachter and Dr. Jha, in their editorial, cited a quote from former boxing champion Mike Tyson: “Everybody has a plan until they’ve been punched in the mouth.” ‘Punches’ such as the new variant, the high number of cases and deaths in the United States, and other problems prompted them to advocate for the delayed dosing strategy.
“Appreciate the concern for the new variant – I think it’s worth noting that we’re punching ourselves in the mouth with the slow vaccine rollout, which is the first problem to solve,” Jake Quinton, MD, an internist at UCLA Health in Los Angeles, noted on Twitter.
Vaccine and public resistance raised
“I agree with the problem but not with the proposed solution, which is guesswork not based on data,” the Jan Grimm Lab at Memorial Sloan Kettering Cancer Center in New York responded to Dr. Wachter and Dr. Jha on Twitter. “There ARE data though that show that 1 shot alone did not elicit sufficient T-cell nor antibody response. This might also lead to mutations resistant to the vaccines. Dangerous!”
Other physicians took to Twitter to point out that changing the recommendations at this point could further erode public confidence in COVID-19 immunization. For example, Deirdre Habermehl, MD, wrote, “We’ve spent months telling the public the best route is to follow the science and now without data think a course correction based on a guesstimate is ok? Public confidence is low enough and the real issue is logistics at this point.”
Dr. Shen and Dr. Bottazzi have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Family Practice News celebrates 50 years
This year, in each issue and on MDedge.com/FamilyMedicine throughout 2021.
We plan to address the biggest breakthroughs and most influential people in family medicine over the past 50 years. The publication will also share family physicians’ expectations and hopes for the specialty in the coming years.
Are there any topics you think would be valuable to cover in light of this major milestone? The editorial staff welcomes your suggestions. Please share them by emailing us at fpnews@mdedge.com.
Happy New Year, and thank you for supporting us for so many years!
This year, in each issue and on MDedge.com/FamilyMedicine throughout 2021.
We plan to address the biggest breakthroughs and most influential people in family medicine over the past 50 years. The publication will also share family physicians’ expectations and hopes for the specialty in the coming years.
Are there any topics you think would be valuable to cover in light of this major milestone? The editorial staff welcomes your suggestions. Please share them by emailing us at fpnews@mdedge.com.
Happy New Year, and thank you for supporting us for so many years!
This year, in each issue and on MDedge.com/FamilyMedicine throughout 2021.
We plan to address the biggest breakthroughs and most influential people in family medicine over the past 50 years. The publication will also share family physicians’ expectations and hopes for the specialty in the coming years.
Are there any topics you think would be valuable to cover in light of this major milestone? The editorial staff welcomes your suggestions. Please share them by emailing us at fpnews@mdedge.com.
Happy New Year, and thank you for supporting us for so many years!
U.S. hits 20 million cases as COVID variant spreads
The United States started 2021 they way it ended 2020: Setting new records amidst the coronavirus pandemic.
The country passed the 20 million mark for coronavirus cases on Friday, setting the mark sometime around noon, according to Johns Hopkins University’s COVID-19 tracker. The total is nearly twice as many as the next worst country – India, which has 10.28 million cases.
Along with the case count, more than 346,000 Americans have now died of COVID-19, the disease caused by the coronavirus. That is 77% more fatalities than Brazil, which ranks second globally with 194,949 deaths.
More than 125,370 coronavirus patients were hospitalized on Thursday, the fourth record-setting day in a row, according to the COVID Tracking Project.
Going by official tallies, it took 292 days for the United States to reach its first 10 million cases, and just 54 more days to double it, CNN reported.
Meanwhile, 12.41 million doses of COVID-19 vaccines have been distributed in the United States as of Wednesday, according to the Centers for Disease Control and Prevention. Yet only 2.8 million people have received the first of a two-shot regimen.
The slower-than-hoped-for rollout of the Pfizer and Moderna vaccines comes as a new variant of the coronavirus has emerged in a third state. Florida officials announced a confirmed case of the new variant – believed to have originated in the United Kingdom – in Martin County in southeast Florida.
The state health department said on Twitter that the patient is a man in his 20s with no history of travel. The department said it is working with the CDC to investigate.
The variant has also been confirmed in cases in Colorado and California. It is believed to be more contagious. The BBC reported that the new variant increases the reproduction, or “R number,” by 0.4 and 0.7. The UK’s most recent R number has been estimated at 1.1-1.3, meaning anyone who has the coronavirus could be assumed to spread it to up to 1.3 people.
The R number needs to be below 1.0 for the spread of the virus to fall.
“There is a huge difference in how easily the variant virus spreads,” Professor Axel Gandy of London’s Imperial College told BBC News. “This is the most serious change in the virus since the epidemic began.”
A version of this article first appeared on WebMD.com.
The United States started 2021 they way it ended 2020: Setting new records amidst the coronavirus pandemic.
The country passed the 20 million mark for coronavirus cases on Friday, setting the mark sometime around noon, according to Johns Hopkins University’s COVID-19 tracker. The total is nearly twice as many as the next worst country – India, which has 10.28 million cases.
Along with the case count, more than 346,000 Americans have now died of COVID-19, the disease caused by the coronavirus. That is 77% more fatalities than Brazil, which ranks second globally with 194,949 deaths.
More than 125,370 coronavirus patients were hospitalized on Thursday, the fourth record-setting day in a row, according to the COVID Tracking Project.
Going by official tallies, it took 292 days for the United States to reach its first 10 million cases, and just 54 more days to double it, CNN reported.
Meanwhile, 12.41 million doses of COVID-19 vaccines have been distributed in the United States as of Wednesday, according to the Centers for Disease Control and Prevention. Yet only 2.8 million people have received the first of a two-shot regimen.
The slower-than-hoped-for rollout of the Pfizer and Moderna vaccines comes as a new variant of the coronavirus has emerged in a third state. Florida officials announced a confirmed case of the new variant – believed to have originated in the United Kingdom – in Martin County in southeast Florida.
The state health department said on Twitter that the patient is a man in his 20s with no history of travel. The department said it is working with the CDC to investigate.
The variant has also been confirmed in cases in Colorado and California. It is believed to be more contagious. The BBC reported that the new variant increases the reproduction, or “R number,” by 0.4 and 0.7. The UK’s most recent R number has been estimated at 1.1-1.3, meaning anyone who has the coronavirus could be assumed to spread it to up to 1.3 people.
The R number needs to be below 1.0 for the spread of the virus to fall.
“There is a huge difference in how easily the variant virus spreads,” Professor Axel Gandy of London’s Imperial College told BBC News. “This is the most serious change in the virus since the epidemic began.”
A version of this article first appeared on WebMD.com.
The United States started 2021 they way it ended 2020: Setting new records amidst the coronavirus pandemic.
The country passed the 20 million mark for coronavirus cases on Friday, setting the mark sometime around noon, according to Johns Hopkins University’s COVID-19 tracker. The total is nearly twice as many as the next worst country – India, which has 10.28 million cases.
Along with the case count, more than 346,000 Americans have now died of COVID-19, the disease caused by the coronavirus. That is 77% more fatalities than Brazil, which ranks second globally with 194,949 deaths.
More than 125,370 coronavirus patients were hospitalized on Thursday, the fourth record-setting day in a row, according to the COVID Tracking Project.
Going by official tallies, it took 292 days for the United States to reach its first 10 million cases, and just 54 more days to double it, CNN reported.
Meanwhile, 12.41 million doses of COVID-19 vaccines have been distributed in the United States as of Wednesday, according to the Centers for Disease Control and Prevention. Yet only 2.8 million people have received the first of a two-shot regimen.
The slower-than-hoped-for rollout of the Pfizer and Moderna vaccines comes as a new variant of the coronavirus has emerged in a third state. Florida officials announced a confirmed case of the new variant – believed to have originated in the United Kingdom – in Martin County in southeast Florida.
The state health department said on Twitter that the patient is a man in his 20s with no history of travel. The department said it is working with the CDC to investigate.
The variant has also been confirmed in cases in Colorado and California. It is believed to be more contagious. The BBC reported that the new variant increases the reproduction, or “R number,” by 0.4 and 0.7. The UK’s most recent R number has been estimated at 1.1-1.3, meaning anyone who has the coronavirus could be assumed to spread it to up to 1.3 people.
The R number needs to be below 1.0 for the spread of the virus to fall.
“There is a huge difference in how easily the variant virus spreads,” Professor Axel Gandy of London’s Imperial College told BBC News. “This is the most serious change in the virus since the epidemic began.”
A version of this article first appeared on WebMD.com.
Still happening: Pelvic exams on anesthetized patients. Why?
“When I was doing ob.gyn. as a med student, the attending would have me do a pelvic right after the patient was under and before we started surgery,” said one participant in an online forum. “We didn’t exactly get permission but it was for teaching purposes.”
Yet others don’t see what the commotion is about. “There are a hundred things that are done during a surgery that don’t require your specific consent (some of them much more ‘humiliating’ than a pelvic exam). ... There’s not really much left to be shy about during a gyn/rectal/prostate surgery, let me put it that way,” one doctor wrote.
However, many physicians are adamantly opposed to the practice, and laws intended to stop or limit it are being enacted throughout the nation.
Renewed concerns have prompted new state laws
A few states have required consent for pelvic exams for many years, beginning with California in 2003. But up until 2019, providing pelvic exams without informed consent was illegal in only six states.
Continuing reports of unauthorized pelvic exams indicate that the practice has not disappeared. University of Michigan professor Maya M. Hammoud, MD, past president of the Association of Professors of Gynecology and Obstetrics, and many others attribute renewed interest in the issue to a 2018 article in the journal Bioethics by Phoebe Friesen, a medical ethicist at McGill University, Montreal, that laid out the ethical arguments against the practice.
Starting in 2019, an outpouring of new state bills have been introduced, and nine more states have passed laws. In addition, 14 other states considered similar bills but did not pass them, in some cases because teaching institutions argued that they were already dealing with the issue. This happened in Connecticut and Massachusetts, after representatives of Yale University, New Haven, Conn., met with legislators.
Laws against the practice have been passed by 15 states, including California, Florida, Illinois, and New York. Some teaching institutions have recently been clamping down on the practice, while many teaching physicians insist that at this point, it has all but ended.
A practice that may still continue
For many years, ethicists, women’s rights groups, state legislators, and organized medicine have been trying to eliminate the practice of unauthorized pelvic exams by medical students. Several key medical groups have come out against it, including the American Medical Association, the Association of American Medical Colleges, and the American College of Obstetricians and Gynecologists.
“Fifteen years ago, studies found a substantial number of cases, but my sense is that most of that has stopped,” said Dr. Hammoud.
Yet despite these changes, there are some disturbing signs that the practice persists.
“I don’t have data, but anecdotally I see it still going on,” said Peter Ubel, MD, a professor at Duke University, Durham, N.C., who was involved in one of those early studies. “Every so often when I’m making a speech, a medical student tells me about performing a pelvic exam without getting permission.
“Perhaps in some cases the attending [physician] did get permission and didn’t tell the medical student, but that would also be a problem,” Dr. Ubel said. “The medical student should be informed that permission was given. This helps them be sensitive to the need to get consent.”
In a 2019 survey of medical students, 92% said they performed a pelvic exam on an anesthetized female patient, and of those, 61% did so without explicit patient consent.
The survey – involving 101 medical students at seven U.S. medical schools – also found that 11% of the medical students said they were extremely uncomfortable with the practice. But nearly one-third of the medical students said that opting out might jeopardize their grades and future careers.
“I tried to opt out once from doing a pelvic exam when I hadn’t met the patient beforehand,” one of them wrote. “The resident told me no.”
Some physicians defend the practice
Why do many medical students and doctors think that getting consent for pelvic exams is not necessary?
Some argue that patients implicitly give consent when they walk through the doors of a teaching hospital. “Sorry, but you inherently agree to that when you’re seen in an academic teaching hospital,” wrote one participant in a Student Doctor Network forum. “You agree to have residents and medical students participate in your care, not just an attending. If you just want an attending, then you are free to go to a nonteaching hospital. That’s the deal.”
Others argued that since the anesthetized patient couldn’t feel what was going on, it shouldn’t matter. “Things like pelvic exams, rectal exams, or even heroic trauma surgery occur for training purposes when there is no memory, no sensation and no harm to be done [and] society gains a better practitioner of the art of medicine,” a physician in Columbus, Ohio, wrote on Quora, an online forum.
Some doctors argue that they don’t ask for specific consent when they touch a variety of other body parts, and pelvic exams should be no different. Pelvic exams are needed before surgery of the pelvic area, but they have also been given to women undergoing surgery in a different part of the body.
In 2019 a woman told Deseret News in Utah that she had been recovering from stomach surgery when a resident physician mentioned something she had noticed “when we looked at your cervix.” When she asked why the physician had examined her cervix to prepare for stomach surgery, “no one could give her a good answer.”
A ‘positive goal’ doesn’t make it okay
What is missing in many defenses of the practice is any recognition that genitals are the most intimate part of the body, and that a patient’s desire for privacy ought to come first. In a survey of women undergoing gynecologic surgery, 72% expected to be asked for consent before medical students undertook pelvic examinations under anesthesia.
Overruling patients’ concerns about their own privacy is unethical, said Eli Y. Adashi, MD, professor of medical science and former dean of medicine and biological sciences at Brown University, Providence, R.I.
Dr. Adashi said the principle of patient autonomy in medical ethics directs that patients must be involved in decision-making about their care – even when caretakers are pursuing a positive goal, such as helping to educate future doctors.
“Conducting pelvic exams on unconscious women without their specific consent is simply untenable and never has been tenable, and it ought to be discontinued if it hasn’t been already,” says Dr. Adashi, who wrote an opinion piece on the issue for JAMA.
Furthermore, it has been shown that ignoring the need to get consent for pelvic exams makes physicians less concerned about getting patient consent in general. A study led by Dr. Ubel found that medical students who had completed an ob.gyn. clerkship thought getting patients’ consent was significantly less important than those who had not completed that clerkship.
Why give pelvic exams to anesthetized women?
Despite the controversy, a number of medical educators continue to direct medical students to perform pelvic exams on anesthetized women. Why is that?
“Pelvic exams are not easy to do,” Dr. Hammoud said. “Learners need to keep working on them; they have to do a lot of them in order to do them well.”
To teach pelvic exams, most medical schools provide standardized patients – paid volunteers who submit to exams and critique the medical student’s work afterwards – but these encounters are limited because of their cost, says Guy Benrubi, MD, professor and emeritus chair of the department of obstetrics and gynecology at the University of Florida, Jacksonville.
He said teaching programs therefore need to supplement exams on standardized patients with exams on unpaid volunteers who provide consent. Programs prefer anesthetized patients, Dr. Benrubi said, because they are easier for novices to work on. “With patients under anesthesia, the muscles are relaxed and it’s easier for learners to detect organs. All the same, you need to get consent.”
Teaching institutions stiffen consent requirements
Faced with growing opposition to pelvic exams without consent, teaching institutions as well as gynecologic educators have recently been tightening their policies.
Dr. Hammoud said she has always informed patients orally about the possibility of medical students performing pelvic exams on them, but now some institutions, including her own, want a more involved process. The university recently began consent in writing for pelvic exams.
In addition, the university also now requires that medical students meet patients before performing pelvic exams and that teaching physicians explain the students’ involvement.
Dr. Hammoud said some institutions now require a separate consent form for pelvic exams, but the University of Michigan simply directs that the possibility of the patient getting a pelvic exam be part of the consent form.
This requirement, called “explicit consent,” was endorsed by APGO. It differs from having a separate consent form for pelvic exams, which would highlight the possibility of a pelvic exam, as many women’s rights activists are calling for.
Why not have a separate form? Dr. Hammoud is concerned that it would unnecessarily alarm patients. “When you point out a certain issue, you’re in effect saying to the patient that this is not normal,” she said, noting that, when asked for consent to do the exams, most women agree to it.
New wave of state laws prompted by renewed concerns
Dr. Hammoud thinks the laws are unnecessary. “These laws are excessive for the vast majority of physicians who practice ethically. The profession should come up with its own standards rather than having a plethora of laws.”
Several of the more recent laws have a broader scope than the original laws. The original laws simply state that medical students or physicians must get informed consent, but they did not stipulate how informed consent should be obtained. (The laws also typically prohibit pelvic exams when surgery will be in a different area of the body.)
The new laws often follow this format, but some go well beyond it. Some also apply to rectal exams (Maine and Maryland), to men as well as women (Utah and Maryland) requires separate consent (Utah), and require consent for all pelvic exams (Florida).
The struggle over Florida’s law
The original Florida bill was drafted in 2019 by state Sen. Lauren Book, a Democrat who is a victims’ rights advocate working with women who have undergone sexual trauma. In written comments for this article, she says not getting consent for pelvic exams is still going on.
“This disturbing practice is commonplace at medical schools and teaching hospitals across the country – including several Florida universities, based on accounts from current and former medical students and faculty,” Sen. Book stated. “At best, these exams have been wrongful learning experiences for medical students or at worst, the equivalent of a sexual assault.”
Dr. Ubel took exception to linking the teaching activities to sexual assault. “I understand why many women would be horrified by this practice, but it’s not as bad as it seems,” he said. “There is nothing sexual or prurient about these exams, and they are motivated purely by a desire to teach people to be better doctors. That said, patients have the right to say, ‘I don’t want it done to me.’ ”
In early 2020, Dr. Benrubi was part of a coalition of medical groups that was trying to influence Sen. Book’s bill as it went through the legislature. Sen. Book’s original bill was relatively mild, “but then, late in the process, it was changed into a more sweeping bill with some unclear language,” he said.
The final version was passed and signed into law by Gov. Ron DeSantis, a conservative Republican, in June.
Dr. Benrubi said that a large number of state legislators, including Sen. Book, have been agreeable to fixing the bill. This was supposed to happen in a special session in the fall, but that never materialized, and so the fix will have to wait until the regular session in early 2021.
“The law should not apply to patients undergoing routine pelvic exams,” Dr. Benrubi said. “It should only apply to women patients under anesthesia.”
But while organized medicine wants to walk back the law, Dr. Book wants to expand it. “This upcoming session, I look forward to working with physicians to continue to hone this new law, and to work toward inclusion for males. Everyone has a right to consent.”
A version of this article first appeared on Medscape.com.
“When I was doing ob.gyn. as a med student, the attending would have me do a pelvic right after the patient was under and before we started surgery,” said one participant in an online forum. “We didn’t exactly get permission but it was for teaching purposes.”
Yet others don’t see what the commotion is about. “There are a hundred things that are done during a surgery that don’t require your specific consent (some of them much more ‘humiliating’ than a pelvic exam). ... There’s not really much left to be shy about during a gyn/rectal/prostate surgery, let me put it that way,” one doctor wrote.
However, many physicians are adamantly opposed to the practice, and laws intended to stop or limit it are being enacted throughout the nation.
Renewed concerns have prompted new state laws
A few states have required consent for pelvic exams for many years, beginning with California in 2003. But up until 2019, providing pelvic exams without informed consent was illegal in only six states.
Continuing reports of unauthorized pelvic exams indicate that the practice has not disappeared. University of Michigan professor Maya M. Hammoud, MD, past president of the Association of Professors of Gynecology and Obstetrics, and many others attribute renewed interest in the issue to a 2018 article in the journal Bioethics by Phoebe Friesen, a medical ethicist at McGill University, Montreal, that laid out the ethical arguments against the practice.
Starting in 2019, an outpouring of new state bills have been introduced, and nine more states have passed laws. In addition, 14 other states considered similar bills but did not pass them, in some cases because teaching institutions argued that they were already dealing with the issue. This happened in Connecticut and Massachusetts, after representatives of Yale University, New Haven, Conn., met with legislators.
Laws against the practice have been passed by 15 states, including California, Florida, Illinois, and New York. Some teaching institutions have recently been clamping down on the practice, while many teaching physicians insist that at this point, it has all but ended.
A practice that may still continue
For many years, ethicists, women’s rights groups, state legislators, and organized medicine have been trying to eliminate the practice of unauthorized pelvic exams by medical students. Several key medical groups have come out against it, including the American Medical Association, the Association of American Medical Colleges, and the American College of Obstetricians and Gynecologists.
“Fifteen years ago, studies found a substantial number of cases, but my sense is that most of that has stopped,” said Dr. Hammoud.
Yet despite these changes, there are some disturbing signs that the practice persists.
“I don’t have data, but anecdotally I see it still going on,” said Peter Ubel, MD, a professor at Duke University, Durham, N.C., who was involved in one of those early studies. “Every so often when I’m making a speech, a medical student tells me about performing a pelvic exam without getting permission.
“Perhaps in some cases the attending [physician] did get permission and didn’t tell the medical student, but that would also be a problem,” Dr. Ubel said. “The medical student should be informed that permission was given. This helps them be sensitive to the need to get consent.”
In a 2019 survey of medical students, 92% said they performed a pelvic exam on an anesthetized female patient, and of those, 61% did so without explicit patient consent.
The survey – involving 101 medical students at seven U.S. medical schools – also found that 11% of the medical students said they were extremely uncomfortable with the practice. But nearly one-third of the medical students said that opting out might jeopardize their grades and future careers.
“I tried to opt out once from doing a pelvic exam when I hadn’t met the patient beforehand,” one of them wrote. “The resident told me no.”
Some physicians defend the practice
Why do many medical students and doctors think that getting consent for pelvic exams is not necessary?
Some argue that patients implicitly give consent when they walk through the doors of a teaching hospital. “Sorry, but you inherently agree to that when you’re seen in an academic teaching hospital,” wrote one participant in a Student Doctor Network forum. “You agree to have residents and medical students participate in your care, not just an attending. If you just want an attending, then you are free to go to a nonteaching hospital. That’s the deal.”
Others argued that since the anesthetized patient couldn’t feel what was going on, it shouldn’t matter. “Things like pelvic exams, rectal exams, or even heroic trauma surgery occur for training purposes when there is no memory, no sensation and no harm to be done [and] society gains a better practitioner of the art of medicine,” a physician in Columbus, Ohio, wrote on Quora, an online forum.
Some doctors argue that they don’t ask for specific consent when they touch a variety of other body parts, and pelvic exams should be no different. Pelvic exams are needed before surgery of the pelvic area, but they have also been given to women undergoing surgery in a different part of the body.
In 2019 a woman told Deseret News in Utah that she had been recovering from stomach surgery when a resident physician mentioned something she had noticed “when we looked at your cervix.” When she asked why the physician had examined her cervix to prepare for stomach surgery, “no one could give her a good answer.”
A ‘positive goal’ doesn’t make it okay
What is missing in many defenses of the practice is any recognition that genitals are the most intimate part of the body, and that a patient’s desire for privacy ought to come first. In a survey of women undergoing gynecologic surgery, 72% expected to be asked for consent before medical students undertook pelvic examinations under anesthesia.
Overruling patients’ concerns about their own privacy is unethical, said Eli Y. Adashi, MD, professor of medical science and former dean of medicine and biological sciences at Brown University, Providence, R.I.
Dr. Adashi said the principle of patient autonomy in medical ethics directs that patients must be involved in decision-making about their care – even when caretakers are pursuing a positive goal, such as helping to educate future doctors.
“Conducting pelvic exams on unconscious women without their specific consent is simply untenable and never has been tenable, and it ought to be discontinued if it hasn’t been already,” says Dr. Adashi, who wrote an opinion piece on the issue for JAMA.
Furthermore, it has been shown that ignoring the need to get consent for pelvic exams makes physicians less concerned about getting patient consent in general. A study led by Dr. Ubel found that medical students who had completed an ob.gyn. clerkship thought getting patients’ consent was significantly less important than those who had not completed that clerkship.
Why give pelvic exams to anesthetized women?
Despite the controversy, a number of medical educators continue to direct medical students to perform pelvic exams on anesthetized women. Why is that?
“Pelvic exams are not easy to do,” Dr. Hammoud said. “Learners need to keep working on them; they have to do a lot of them in order to do them well.”
To teach pelvic exams, most medical schools provide standardized patients – paid volunteers who submit to exams and critique the medical student’s work afterwards – but these encounters are limited because of their cost, says Guy Benrubi, MD, professor and emeritus chair of the department of obstetrics and gynecology at the University of Florida, Jacksonville.
He said teaching programs therefore need to supplement exams on standardized patients with exams on unpaid volunteers who provide consent. Programs prefer anesthetized patients, Dr. Benrubi said, because they are easier for novices to work on. “With patients under anesthesia, the muscles are relaxed and it’s easier for learners to detect organs. All the same, you need to get consent.”
Teaching institutions stiffen consent requirements
Faced with growing opposition to pelvic exams without consent, teaching institutions as well as gynecologic educators have recently been tightening their policies.
Dr. Hammoud said she has always informed patients orally about the possibility of medical students performing pelvic exams on them, but now some institutions, including her own, want a more involved process. The university recently began consent in writing for pelvic exams.
In addition, the university also now requires that medical students meet patients before performing pelvic exams and that teaching physicians explain the students’ involvement.
Dr. Hammoud said some institutions now require a separate consent form for pelvic exams, but the University of Michigan simply directs that the possibility of the patient getting a pelvic exam be part of the consent form.
This requirement, called “explicit consent,” was endorsed by APGO. It differs from having a separate consent form for pelvic exams, which would highlight the possibility of a pelvic exam, as many women’s rights activists are calling for.
Why not have a separate form? Dr. Hammoud is concerned that it would unnecessarily alarm patients. “When you point out a certain issue, you’re in effect saying to the patient that this is not normal,” she said, noting that, when asked for consent to do the exams, most women agree to it.
New wave of state laws prompted by renewed concerns
Dr. Hammoud thinks the laws are unnecessary. “These laws are excessive for the vast majority of physicians who practice ethically. The profession should come up with its own standards rather than having a plethora of laws.”
Several of the more recent laws have a broader scope than the original laws. The original laws simply state that medical students or physicians must get informed consent, but they did not stipulate how informed consent should be obtained. (The laws also typically prohibit pelvic exams when surgery will be in a different area of the body.)
The new laws often follow this format, but some go well beyond it. Some also apply to rectal exams (Maine and Maryland), to men as well as women (Utah and Maryland) requires separate consent (Utah), and require consent for all pelvic exams (Florida).
The struggle over Florida’s law
The original Florida bill was drafted in 2019 by state Sen. Lauren Book, a Democrat who is a victims’ rights advocate working with women who have undergone sexual trauma. In written comments for this article, she says not getting consent for pelvic exams is still going on.
“This disturbing practice is commonplace at medical schools and teaching hospitals across the country – including several Florida universities, based on accounts from current and former medical students and faculty,” Sen. Book stated. “At best, these exams have been wrongful learning experiences for medical students or at worst, the equivalent of a sexual assault.”
Dr. Ubel took exception to linking the teaching activities to sexual assault. “I understand why many women would be horrified by this practice, but it’s not as bad as it seems,” he said. “There is nothing sexual or prurient about these exams, and they are motivated purely by a desire to teach people to be better doctors. That said, patients have the right to say, ‘I don’t want it done to me.’ ”
In early 2020, Dr. Benrubi was part of a coalition of medical groups that was trying to influence Sen. Book’s bill as it went through the legislature. Sen. Book’s original bill was relatively mild, “but then, late in the process, it was changed into a more sweeping bill with some unclear language,” he said.
The final version was passed and signed into law by Gov. Ron DeSantis, a conservative Republican, in June.
Dr. Benrubi said that a large number of state legislators, including Sen. Book, have been agreeable to fixing the bill. This was supposed to happen in a special session in the fall, but that never materialized, and so the fix will have to wait until the regular session in early 2021.
“The law should not apply to patients undergoing routine pelvic exams,” Dr. Benrubi said. “It should only apply to women patients under anesthesia.”
But while organized medicine wants to walk back the law, Dr. Book wants to expand it. “This upcoming session, I look forward to working with physicians to continue to hone this new law, and to work toward inclusion for males. Everyone has a right to consent.”
A version of this article first appeared on Medscape.com.
“When I was doing ob.gyn. as a med student, the attending would have me do a pelvic right after the patient was under and before we started surgery,” said one participant in an online forum. “We didn’t exactly get permission but it was for teaching purposes.”
Yet others don’t see what the commotion is about. “There are a hundred things that are done during a surgery that don’t require your specific consent (some of them much more ‘humiliating’ than a pelvic exam). ... There’s not really much left to be shy about during a gyn/rectal/prostate surgery, let me put it that way,” one doctor wrote.
However, many physicians are adamantly opposed to the practice, and laws intended to stop or limit it are being enacted throughout the nation.
Renewed concerns have prompted new state laws
A few states have required consent for pelvic exams for many years, beginning with California in 2003. But up until 2019, providing pelvic exams without informed consent was illegal in only six states.
Continuing reports of unauthorized pelvic exams indicate that the practice has not disappeared. University of Michigan professor Maya M. Hammoud, MD, past president of the Association of Professors of Gynecology and Obstetrics, and many others attribute renewed interest in the issue to a 2018 article in the journal Bioethics by Phoebe Friesen, a medical ethicist at McGill University, Montreal, that laid out the ethical arguments against the practice.
Starting in 2019, an outpouring of new state bills have been introduced, and nine more states have passed laws. In addition, 14 other states considered similar bills but did not pass them, in some cases because teaching institutions argued that they were already dealing with the issue. This happened in Connecticut and Massachusetts, after representatives of Yale University, New Haven, Conn., met with legislators.
Laws against the practice have been passed by 15 states, including California, Florida, Illinois, and New York. Some teaching institutions have recently been clamping down on the practice, while many teaching physicians insist that at this point, it has all but ended.
A practice that may still continue
For many years, ethicists, women’s rights groups, state legislators, and organized medicine have been trying to eliminate the practice of unauthorized pelvic exams by medical students. Several key medical groups have come out against it, including the American Medical Association, the Association of American Medical Colleges, and the American College of Obstetricians and Gynecologists.
“Fifteen years ago, studies found a substantial number of cases, but my sense is that most of that has stopped,” said Dr. Hammoud.
Yet despite these changes, there are some disturbing signs that the practice persists.
“I don’t have data, but anecdotally I see it still going on,” said Peter Ubel, MD, a professor at Duke University, Durham, N.C., who was involved in one of those early studies. “Every so often when I’m making a speech, a medical student tells me about performing a pelvic exam without getting permission.
“Perhaps in some cases the attending [physician] did get permission and didn’t tell the medical student, but that would also be a problem,” Dr. Ubel said. “The medical student should be informed that permission was given. This helps them be sensitive to the need to get consent.”
In a 2019 survey of medical students, 92% said they performed a pelvic exam on an anesthetized female patient, and of those, 61% did so without explicit patient consent.
The survey – involving 101 medical students at seven U.S. medical schools – also found that 11% of the medical students said they were extremely uncomfortable with the practice. But nearly one-third of the medical students said that opting out might jeopardize their grades and future careers.
“I tried to opt out once from doing a pelvic exam when I hadn’t met the patient beforehand,” one of them wrote. “The resident told me no.”
Some physicians defend the practice
Why do many medical students and doctors think that getting consent for pelvic exams is not necessary?
Some argue that patients implicitly give consent when they walk through the doors of a teaching hospital. “Sorry, but you inherently agree to that when you’re seen in an academic teaching hospital,” wrote one participant in a Student Doctor Network forum. “You agree to have residents and medical students participate in your care, not just an attending. If you just want an attending, then you are free to go to a nonteaching hospital. That’s the deal.”
Others argued that since the anesthetized patient couldn’t feel what was going on, it shouldn’t matter. “Things like pelvic exams, rectal exams, or even heroic trauma surgery occur for training purposes when there is no memory, no sensation and no harm to be done [and] society gains a better practitioner of the art of medicine,” a physician in Columbus, Ohio, wrote on Quora, an online forum.
Some doctors argue that they don’t ask for specific consent when they touch a variety of other body parts, and pelvic exams should be no different. Pelvic exams are needed before surgery of the pelvic area, but they have also been given to women undergoing surgery in a different part of the body.
In 2019 a woman told Deseret News in Utah that she had been recovering from stomach surgery when a resident physician mentioned something she had noticed “when we looked at your cervix.” When she asked why the physician had examined her cervix to prepare for stomach surgery, “no one could give her a good answer.”
A ‘positive goal’ doesn’t make it okay
What is missing in many defenses of the practice is any recognition that genitals are the most intimate part of the body, and that a patient’s desire for privacy ought to come first. In a survey of women undergoing gynecologic surgery, 72% expected to be asked for consent before medical students undertook pelvic examinations under anesthesia.
Overruling patients’ concerns about their own privacy is unethical, said Eli Y. Adashi, MD, professor of medical science and former dean of medicine and biological sciences at Brown University, Providence, R.I.
Dr. Adashi said the principle of patient autonomy in medical ethics directs that patients must be involved in decision-making about their care – even when caretakers are pursuing a positive goal, such as helping to educate future doctors.
“Conducting pelvic exams on unconscious women without their specific consent is simply untenable and never has been tenable, and it ought to be discontinued if it hasn’t been already,” says Dr. Adashi, who wrote an opinion piece on the issue for JAMA.
Furthermore, it has been shown that ignoring the need to get consent for pelvic exams makes physicians less concerned about getting patient consent in general. A study led by Dr. Ubel found that medical students who had completed an ob.gyn. clerkship thought getting patients’ consent was significantly less important than those who had not completed that clerkship.
Why give pelvic exams to anesthetized women?
Despite the controversy, a number of medical educators continue to direct medical students to perform pelvic exams on anesthetized women. Why is that?
“Pelvic exams are not easy to do,” Dr. Hammoud said. “Learners need to keep working on them; they have to do a lot of them in order to do them well.”
To teach pelvic exams, most medical schools provide standardized patients – paid volunteers who submit to exams and critique the medical student’s work afterwards – but these encounters are limited because of their cost, says Guy Benrubi, MD, professor and emeritus chair of the department of obstetrics and gynecology at the University of Florida, Jacksonville.
He said teaching programs therefore need to supplement exams on standardized patients with exams on unpaid volunteers who provide consent. Programs prefer anesthetized patients, Dr. Benrubi said, because they are easier for novices to work on. “With patients under anesthesia, the muscles are relaxed and it’s easier for learners to detect organs. All the same, you need to get consent.”
Teaching institutions stiffen consent requirements
Faced with growing opposition to pelvic exams without consent, teaching institutions as well as gynecologic educators have recently been tightening their policies.
Dr. Hammoud said she has always informed patients orally about the possibility of medical students performing pelvic exams on them, but now some institutions, including her own, want a more involved process. The university recently began consent in writing for pelvic exams.
In addition, the university also now requires that medical students meet patients before performing pelvic exams and that teaching physicians explain the students’ involvement.
Dr. Hammoud said some institutions now require a separate consent form for pelvic exams, but the University of Michigan simply directs that the possibility of the patient getting a pelvic exam be part of the consent form.
This requirement, called “explicit consent,” was endorsed by APGO. It differs from having a separate consent form for pelvic exams, which would highlight the possibility of a pelvic exam, as many women’s rights activists are calling for.
Why not have a separate form? Dr. Hammoud is concerned that it would unnecessarily alarm patients. “When you point out a certain issue, you’re in effect saying to the patient that this is not normal,” she said, noting that, when asked for consent to do the exams, most women agree to it.
New wave of state laws prompted by renewed concerns
Dr. Hammoud thinks the laws are unnecessary. “These laws are excessive for the vast majority of physicians who practice ethically. The profession should come up with its own standards rather than having a plethora of laws.”
Several of the more recent laws have a broader scope than the original laws. The original laws simply state that medical students or physicians must get informed consent, but they did not stipulate how informed consent should be obtained. (The laws also typically prohibit pelvic exams when surgery will be in a different area of the body.)
The new laws often follow this format, but some go well beyond it. Some also apply to rectal exams (Maine and Maryland), to men as well as women (Utah and Maryland) requires separate consent (Utah), and require consent for all pelvic exams (Florida).
The struggle over Florida’s law
The original Florida bill was drafted in 2019 by state Sen. Lauren Book, a Democrat who is a victims’ rights advocate working with women who have undergone sexual trauma. In written comments for this article, she says not getting consent for pelvic exams is still going on.
“This disturbing practice is commonplace at medical schools and teaching hospitals across the country – including several Florida universities, based on accounts from current and former medical students and faculty,” Sen. Book stated. “At best, these exams have been wrongful learning experiences for medical students or at worst, the equivalent of a sexual assault.”
Dr. Ubel took exception to linking the teaching activities to sexual assault. “I understand why many women would be horrified by this practice, but it’s not as bad as it seems,” he said. “There is nothing sexual or prurient about these exams, and they are motivated purely by a desire to teach people to be better doctors. That said, patients have the right to say, ‘I don’t want it done to me.’ ”
In early 2020, Dr. Benrubi was part of a coalition of medical groups that was trying to influence Sen. Book’s bill as it went through the legislature. Sen. Book’s original bill was relatively mild, “but then, late in the process, it was changed into a more sweeping bill with some unclear language,” he said.
The final version was passed and signed into law by Gov. Ron DeSantis, a conservative Republican, in June.
Dr. Benrubi said that a large number of state legislators, including Sen. Book, have been agreeable to fixing the bill. This was supposed to happen in a special session in the fall, but that never materialized, and so the fix will have to wait until the regular session in early 2021.
“The law should not apply to patients undergoing routine pelvic exams,” Dr. Benrubi said. “It should only apply to women patients under anesthesia.”
But while organized medicine wants to walk back the law, Dr. Book wants to expand it. “This upcoming session, I look forward to working with physicians to continue to hone this new law, and to work toward inclusion for males. Everyone has a right to consent.”
A version of this article first appeared on Medscape.com.
Medicaid to cover routine costs for patients in trials
A boost for patients with cancer and other serious illnesses.
Congress has ordered the holdouts among U.S. states to have their Medicaid programs cover expenses related to participation in certain clinical trials, a move that was hailed by the American Society of Clinical Oncology and other groups as a boost to trials as well as to patients with serious illness who have lower incomes.
A massive wrap-up spending/COVID-19 relief bill that was signed into law Dec. 27 carried with it a mandate on Medicaid. States are ordered to put in place Medicaid payment policies for routine items and services, such as the cost of physician visits or laboratory tests, that are provided in connection with participation in clinical trials for serious and life-threatening conditions. The law includes a January 2022 target date for this coverage through Medicaid.
Medicare and other large insurers already pick up the tab for these kinds of expenses, leaving Medicaid as an outlier, ASCO noted in a press statement. ASCO and other cancer groups have for years pressed Medicaid to cover routine expenses for people participating in clinical trials. Already, 15 states, including California, require their Medicaid programs to cover these expenses, according to ASCO.
“We believe that the trials can bring extra benefits to patients,” said Monica M. Bertagnolli, MD, of Dana-Farber Cancer Institute, Boston. Dr. Bertagnolli has worked for years to secure Medicaid coverage for expenses connected to clinical trials.
Although Medicaid covers costs of standard care for cancer patients, people enrolled in the program may have concerns about participating in clinical studies, said Dr. Bertagnolli, chair of the Association for Clinical Oncology, which was established by ASCO to promote wider access to cancer care. Having extra medical expenses may be more than these patients can tolerate.
“Many of them just say, ‘I can’t take that financial risk, so I’ll just stay with standard of care,’ “ Dr. Bertagnolli said in an interview.
Equity issues
Medicaid has expanded greatly, owing to financial aid provided to states through the Affordable Care Act of 2010.
To date, 38 of 50 U.S. states have accepted federal aid to lift income limits for Medicaid eligibility, according to a tally kept by the nonprofit Kaiser Family Foundation. This Medicaid expansion has given more of the nation’s working poor access to health.care, including cancer treatment. Between 2013 and January 2020, enrollment in Medicaid in expansion states increased by about 12.4 million, according to the Medicaid and CHIP Payment and Access Commission.
Medicaid is the nation’s dominant health insurer. Enrollment has been around 70 million in recent months.
That tops the 61 million enrolled in Medicare, the federal program for people aged 65 and older and those with disabilities. (There’s some overlap between Medicare and Medicaid. About 12.8 million persons were dually eligible for these programs in 2018.) UnitedHealth, a giant private insurer, has about 43 million domestic customers.
Medicaid also serves many of the groups of people for which researchers have been seeking to increase participation in clinical trials. ASCO’s Association for Clinical Oncology and dozens of its partners raised this point in a letter to congressional leaders on Feb. 15, 2020.
“Lack of participation in clinical trials from the Medicaid population means these patients are being excluded from potentially life-saving trials and are not reflected in the outcome of the clinical research,” the groups wrote. “Increased access to clinical trial participation for Medicaid enrollees helps ensure medical research results more accurately capture and reflect the populations of this country.”
The ACA’s Medicaid expansion is working to address some of the racial gaps in insurance coverage, according to a January 2020 report from the nonprofit Commonwealth Fund.
Black and Hispanic adults are almost twice as likely as are White adults to have incomes that are less than 200% of the federal poverty level, according to the Commonwealth Fund report. The report also said that people in these groups reported significantly higher rates of cost-related problems in receiving care before the Medicaid expansion began in 2014.
The uninsured rate for Black adults dropped from 24.4% in 2013 to 14.4% in 2018; the rate for Hispanic adults fell from 40.2% to 24.9%, according to the Commonwealth Fund report.
There are concerns, though, about attempts by some governors to impose onerous restrictions on adults enrolled in Medicaid, Dr. Bertagnolli said. She was president of ASCO in 2018 when the group called on the Centers for Medicare & Medicaid Services to reject state requests to create restrictions that could hinder people’s access to cancer screening or care.
The Trump administration encouraged governors to adopt work requirements. As a result, a dozen states approved these policies, according to a November report from the nonprofit Center on Budget and Policy Priorities. The efforts were blocked by courts.
Data from the limited period of implementation in Arkansas, Michigan, and New Hampshire provide evidence that these kinds of requirements don’t work as intended, according to the CBPP report.
“In all three states, evidence suggests that people who were working and people with serious health needs who should have been eligible for exemptions lost coverage or were at risk of losing coverage due to red tape,” CBPP analysts Jennifer Wagner and Jessica Schubel wrote in their report.
In 2019, The New England Journal of Medicine published an article about the early stages of the Arkansas experiment with Medicaid work rules. Almost 17,000 adults lost their health care coverage in the initial months of implementation, but there appeared to be no significant difference in employment, Benjamin Sommers, MD, PhD, of the Harvard School of Public Health, Boston, and colleagues wrote in their article.
For many people in Arkansas, coverage was lost because of difficulties in reporting compliance with the Medicaid work rule, not because of the employment mandate itself, according to the authors. More than 95% of persons who were targeted by Arkansas’ Medicaid work policy already met its requirements or should have been exempt, they wrote.
Democrats have tended to oppose efforts to attach work requirements, which can include volunteer activities or career training, to Medicaid. Dr. Bertagnolli said there is a need to guard against any future bid to add work requirements to the program.
Extra bureaucratic hurdles may pose an especially tough burden on working adults enrolled in Medicaid, she said.
People who qualify for the program may already be worried about their finances while juggling continued demands of child care and employment, she said. They don’t need to be put at risk of losing access to medical care over administrative rules while undergoing cancer treatment, she said.
“We have to take care of people who are sick. That’s just the way it is,” Dr. Bertagnolli said.
A version of this article first appeared on Medscape.com.
A boost for patients with cancer and other serious illnesses.
A boost for patients with cancer and other serious illnesses.
Congress has ordered the holdouts among U.S. states to have their Medicaid programs cover expenses related to participation in certain clinical trials, a move that was hailed by the American Society of Clinical Oncology and other groups as a boost to trials as well as to patients with serious illness who have lower incomes.
A massive wrap-up spending/COVID-19 relief bill that was signed into law Dec. 27 carried with it a mandate on Medicaid. States are ordered to put in place Medicaid payment policies for routine items and services, such as the cost of physician visits or laboratory tests, that are provided in connection with participation in clinical trials for serious and life-threatening conditions. The law includes a January 2022 target date for this coverage through Medicaid.
Medicare and other large insurers already pick up the tab for these kinds of expenses, leaving Medicaid as an outlier, ASCO noted in a press statement. ASCO and other cancer groups have for years pressed Medicaid to cover routine expenses for people participating in clinical trials. Already, 15 states, including California, require their Medicaid programs to cover these expenses, according to ASCO.
“We believe that the trials can bring extra benefits to patients,” said Monica M. Bertagnolli, MD, of Dana-Farber Cancer Institute, Boston. Dr. Bertagnolli has worked for years to secure Medicaid coverage for expenses connected to clinical trials.
Although Medicaid covers costs of standard care for cancer patients, people enrolled in the program may have concerns about participating in clinical studies, said Dr. Bertagnolli, chair of the Association for Clinical Oncology, which was established by ASCO to promote wider access to cancer care. Having extra medical expenses may be more than these patients can tolerate.
“Many of them just say, ‘I can’t take that financial risk, so I’ll just stay with standard of care,’ “ Dr. Bertagnolli said in an interview.
Equity issues
Medicaid has expanded greatly, owing to financial aid provided to states through the Affordable Care Act of 2010.
To date, 38 of 50 U.S. states have accepted federal aid to lift income limits for Medicaid eligibility, according to a tally kept by the nonprofit Kaiser Family Foundation. This Medicaid expansion has given more of the nation’s working poor access to health.care, including cancer treatment. Between 2013 and January 2020, enrollment in Medicaid in expansion states increased by about 12.4 million, according to the Medicaid and CHIP Payment and Access Commission.
Medicaid is the nation’s dominant health insurer. Enrollment has been around 70 million in recent months.
That tops the 61 million enrolled in Medicare, the federal program for people aged 65 and older and those with disabilities. (There’s some overlap between Medicare and Medicaid. About 12.8 million persons were dually eligible for these programs in 2018.) UnitedHealth, a giant private insurer, has about 43 million domestic customers.
Medicaid also serves many of the groups of people for which researchers have been seeking to increase participation in clinical trials. ASCO’s Association for Clinical Oncology and dozens of its partners raised this point in a letter to congressional leaders on Feb. 15, 2020.
“Lack of participation in clinical trials from the Medicaid population means these patients are being excluded from potentially life-saving trials and are not reflected in the outcome of the clinical research,” the groups wrote. “Increased access to clinical trial participation for Medicaid enrollees helps ensure medical research results more accurately capture and reflect the populations of this country.”
The ACA’s Medicaid expansion is working to address some of the racial gaps in insurance coverage, according to a January 2020 report from the nonprofit Commonwealth Fund.
Black and Hispanic adults are almost twice as likely as are White adults to have incomes that are less than 200% of the federal poverty level, according to the Commonwealth Fund report. The report also said that people in these groups reported significantly higher rates of cost-related problems in receiving care before the Medicaid expansion began in 2014.
The uninsured rate for Black adults dropped from 24.4% in 2013 to 14.4% in 2018; the rate for Hispanic adults fell from 40.2% to 24.9%, according to the Commonwealth Fund report.
There are concerns, though, about attempts by some governors to impose onerous restrictions on adults enrolled in Medicaid, Dr. Bertagnolli said. She was president of ASCO in 2018 when the group called on the Centers for Medicare & Medicaid Services to reject state requests to create restrictions that could hinder people’s access to cancer screening or care.
The Trump administration encouraged governors to adopt work requirements. As a result, a dozen states approved these policies, according to a November report from the nonprofit Center on Budget and Policy Priorities. The efforts were blocked by courts.
Data from the limited period of implementation in Arkansas, Michigan, and New Hampshire provide evidence that these kinds of requirements don’t work as intended, according to the CBPP report.
“In all three states, evidence suggests that people who were working and people with serious health needs who should have been eligible for exemptions lost coverage or were at risk of losing coverage due to red tape,” CBPP analysts Jennifer Wagner and Jessica Schubel wrote in their report.
In 2019, The New England Journal of Medicine published an article about the early stages of the Arkansas experiment with Medicaid work rules. Almost 17,000 adults lost their health care coverage in the initial months of implementation, but there appeared to be no significant difference in employment, Benjamin Sommers, MD, PhD, of the Harvard School of Public Health, Boston, and colleagues wrote in their article.
For many people in Arkansas, coverage was lost because of difficulties in reporting compliance with the Medicaid work rule, not because of the employment mandate itself, according to the authors. More than 95% of persons who were targeted by Arkansas’ Medicaid work policy already met its requirements or should have been exempt, they wrote.
Democrats have tended to oppose efforts to attach work requirements, which can include volunteer activities or career training, to Medicaid. Dr. Bertagnolli said there is a need to guard against any future bid to add work requirements to the program.
Extra bureaucratic hurdles may pose an especially tough burden on working adults enrolled in Medicaid, she said.
People who qualify for the program may already be worried about their finances while juggling continued demands of child care and employment, she said. They don’t need to be put at risk of losing access to medical care over administrative rules while undergoing cancer treatment, she said.
“We have to take care of people who are sick. That’s just the way it is,” Dr. Bertagnolli said.
A version of this article first appeared on Medscape.com.
Congress has ordered the holdouts among U.S. states to have their Medicaid programs cover expenses related to participation in certain clinical trials, a move that was hailed by the American Society of Clinical Oncology and other groups as a boost to trials as well as to patients with serious illness who have lower incomes.
A massive wrap-up spending/COVID-19 relief bill that was signed into law Dec. 27 carried with it a mandate on Medicaid. States are ordered to put in place Medicaid payment policies for routine items and services, such as the cost of physician visits or laboratory tests, that are provided in connection with participation in clinical trials for serious and life-threatening conditions. The law includes a January 2022 target date for this coverage through Medicaid.
Medicare and other large insurers already pick up the tab for these kinds of expenses, leaving Medicaid as an outlier, ASCO noted in a press statement. ASCO and other cancer groups have for years pressed Medicaid to cover routine expenses for people participating in clinical trials. Already, 15 states, including California, require their Medicaid programs to cover these expenses, according to ASCO.
“We believe that the trials can bring extra benefits to patients,” said Monica M. Bertagnolli, MD, of Dana-Farber Cancer Institute, Boston. Dr. Bertagnolli has worked for years to secure Medicaid coverage for expenses connected to clinical trials.
Although Medicaid covers costs of standard care for cancer patients, people enrolled in the program may have concerns about participating in clinical studies, said Dr. Bertagnolli, chair of the Association for Clinical Oncology, which was established by ASCO to promote wider access to cancer care. Having extra medical expenses may be more than these patients can tolerate.
“Many of them just say, ‘I can’t take that financial risk, so I’ll just stay with standard of care,’ “ Dr. Bertagnolli said in an interview.
Equity issues
Medicaid has expanded greatly, owing to financial aid provided to states through the Affordable Care Act of 2010.
To date, 38 of 50 U.S. states have accepted federal aid to lift income limits for Medicaid eligibility, according to a tally kept by the nonprofit Kaiser Family Foundation. This Medicaid expansion has given more of the nation’s working poor access to health.care, including cancer treatment. Between 2013 and January 2020, enrollment in Medicaid in expansion states increased by about 12.4 million, according to the Medicaid and CHIP Payment and Access Commission.
Medicaid is the nation’s dominant health insurer. Enrollment has been around 70 million in recent months.
That tops the 61 million enrolled in Medicare, the federal program for people aged 65 and older and those with disabilities. (There’s some overlap between Medicare and Medicaid. About 12.8 million persons were dually eligible for these programs in 2018.) UnitedHealth, a giant private insurer, has about 43 million domestic customers.
Medicaid also serves many of the groups of people for which researchers have been seeking to increase participation in clinical trials. ASCO’s Association for Clinical Oncology and dozens of its partners raised this point in a letter to congressional leaders on Feb. 15, 2020.
“Lack of participation in clinical trials from the Medicaid population means these patients are being excluded from potentially life-saving trials and are not reflected in the outcome of the clinical research,” the groups wrote. “Increased access to clinical trial participation for Medicaid enrollees helps ensure medical research results more accurately capture and reflect the populations of this country.”
The ACA’s Medicaid expansion is working to address some of the racial gaps in insurance coverage, according to a January 2020 report from the nonprofit Commonwealth Fund.
Black and Hispanic adults are almost twice as likely as are White adults to have incomes that are less than 200% of the federal poverty level, according to the Commonwealth Fund report. The report also said that people in these groups reported significantly higher rates of cost-related problems in receiving care before the Medicaid expansion began in 2014.
The uninsured rate for Black adults dropped from 24.4% in 2013 to 14.4% in 2018; the rate for Hispanic adults fell from 40.2% to 24.9%, according to the Commonwealth Fund report.
There are concerns, though, about attempts by some governors to impose onerous restrictions on adults enrolled in Medicaid, Dr. Bertagnolli said. She was president of ASCO in 2018 when the group called on the Centers for Medicare & Medicaid Services to reject state requests to create restrictions that could hinder people’s access to cancer screening or care.
The Trump administration encouraged governors to adopt work requirements. As a result, a dozen states approved these policies, according to a November report from the nonprofit Center on Budget and Policy Priorities. The efforts were blocked by courts.
Data from the limited period of implementation in Arkansas, Michigan, and New Hampshire provide evidence that these kinds of requirements don’t work as intended, according to the CBPP report.
“In all three states, evidence suggests that people who were working and people with serious health needs who should have been eligible for exemptions lost coverage or were at risk of losing coverage due to red tape,” CBPP analysts Jennifer Wagner and Jessica Schubel wrote in their report.
In 2019, The New England Journal of Medicine published an article about the early stages of the Arkansas experiment with Medicaid work rules. Almost 17,000 adults lost their health care coverage in the initial months of implementation, but there appeared to be no significant difference in employment, Benjamin Sommers, MD, PhD, of the Harvard School of Public Health, Boston, and colleagues wrote in their article.
For many people in Arkansas, coverage was lost because of difficulties in reporting compliance with the Medicaid work rule, not because of the employment mandate itself, according to the authors. More than 95% of persons who were targeted by Arkansas’ Medicaid work policy already met its requirements or should have been exempt, they wrote.
Democrats have tended to oppose efforts to attach work requirements, which can include volunteer activities or career training, to Medicaid. Dr. Bertagnolli said there is a need to guard against any future bid to add work requirements to the program.
Extra bureaucratic hurdles may pose an especially tough burden on working adults enrolled in Medicaid, she said.
People who qualify for the program may already be worried about their finances while juggling continued demands of child care and employment, she said. They don’t need to be put at risk of losing access to medical care over administrative rules while undergoing cancer treatment, she said.
“We have to take care of people who are sick. That’s just the way it is,” Dr. Bertagnolli said.
A version of this article first appeared on Medscape.com.
COVID-19 vaccine rollout faces delays
If the current pace of vaccination continues, “it’s going to take years, not months, to vaccinate the American people,” President-elect Joe Biden said during a briefing Dec. 29.
In fact, at the current rate, it would take nearly 10 years to vaccinate enough Americans to bring the pandemic under control, according to NBC News. To reach 80% of the country by late June, 3 million people would need to receive a COVID-19 vaccine each day.
“As I long feared and warned, the effort to distribute and administer the vaccine is not progressing as it should,” Mr. Biden said, reemphasizing his pledge to get 100 million doses to Americans during his first 100 days as president.
So far, 11.4 million doses have been distributed and 2.1 million people have received a vaccine, according to the Centers for Disease Control and Prevention. Most states have administered a fraction of the doses they’ve received, according to data compiled by The New York Times.
Federal officials have said there’s an “expected lag” between delivery of doses, shots going into arms, and the data being reported to the CDC, according to CNN. The Food and Drug Administration must assess each shipment for quality control, which has slowed down distribution, and the CDC data are just now beginning to include the Moderna vaccine, which the FDA authorized for emergency use on Dec. 18.
The 2.1 million number is “an underestimate,” Brett Giroir, MD, the assistant secretary of the U.S. Department of Health & Human Services, told NBC News Dec. 29. At the same time, the U.S. won’t meet the goal of vaccinating 20 million people in the next few days, he said.
Another 30 million doses will go out in January, Dr. Giroir said, followed by 50 million in February.
Some vaccine experts have said they’re not surprised by the speed of vaccine distribution.
“It had to go this way,” Paul Offit, MD, a professor of pediatrics at Children’s Hospital of Philadelphia, told STAT. “We had to trip and fall and stumble and figure this out.”
To speed up distribution in 2021, the federal government will need to help states, Mr. Biden said Dec. 29. He plans to use the Defense Authorization Act to ramp up production of vaccine supplies. Even still, the process will take months, he said.
A version of this article first appeared on WebMD.com .
If the current pace of vaccination continues, “it’s going to take years, not months, to vaccinate the American people,” President-elect Joe Biden said during a briefing Dec. 29.
In fact, at the current rate, it would take nearly 10 years to vaccinate enough Americans to bring the pandemic under control, according to NBC News. To reach 80% of the country by late June, 3 million people would need to receive a COVID-19 vaccine each day.
“As I long feared and warned, the effort to distribute and administer the vaccine is not progressing as it should,” Mr. Biden said, reemphasizing his pledge to get 100 million doses to Americans during his first 100 days as president.
So far, 11.4 million doses have been distributed and 2.1 million people have received a vaccine, according to the Centers for Disease Control and Prevention. Most states have administered a fraction of the doses they’ve received, according to data compiled by The New York Times.
Federal officials have said there’s an “expected lag” between delivery of doses, shots going into arms, and the data being reported to the CDC, according to CNN. The Food and Drug Administration must assess each shipment for quality control, which has slowed down distribution, and the CDC data are just now beginning to include the Moderna vaccine, which the FDA authorized for emergency use on Dec. 18.
The 2.1 million number is “an underestimate,” Brett Giroir, MD, the assistant secretary of the U.S. Department of Health & Human Services, told NBC News Dec. 29. At the same time, the U.S. won’t meet the goal of vaccinating 20 million people in the next few days, he said.
Another 30 million doses will go out in January, Dr. Giroir said, followed by 50 million in February.
Some vaccine experts have said they’re not surprised by the speed of vaccine distribution.
“It had to go this way,” Paul Offit, MD, a professor of pediatrics at Children’s Hospital of Philadelphia, told STAT. “We had to trip and fall and stumble and figure this out.”
To speed up distribution in 2021, the federal government will need to help states, Mr. Biden said Dec. 29. He plans to use the Defense Authorization Act to ramp up production of vaccine supplies. Even still, the process will take months, he said.
A version of this article first appeared on WebMD.com .
If the current pace of vaccination continues, “it’s going to take years, not months, to vaccinate the American people,” President-elect Joe Biden said during a briefing Dec. 29.
In fact, at the current rate, it would take nearly 10 years to vaccinate enough Americans to bring the pandemic under control, according to NBC News. To reach 80% of the country by late June, 3 million people would need to receive a COVID-19 vaccine each day.
“As I long feared and warned, the effort to distribute and administer the vaccine is not progressing as it should,” Mr. Biden said, reemphasizing his pledge to get 100 million doses to Americans during his first 100 days as president.
So far, 11.4 million doses have been distributed and 2.1 million people have received a vaccine, according to the Centers for Disease Control and Prevention. Most states have administered a fraction of the doses they’ve received, according to data compiled by The New York Times.
Federal officials have said there’s an “expected lag” between delivery of doses, shots going into arms, and the data being reported to the CDC, according to CNN. The Food and Drug Administration must assess each shipment for quality control, which has slowed down distribution, and the CDC data are just now beginning to include the Moderna vaccine, which the FDA authorized for emergency use on Dec. 18.
The 2.1 million number is “an underestimate,” Brett Giroir, MD, the assistant secretary of the U.S. Department of Health & Human Services, told NBC News Dec. 29. At the same time, the U.S. won’t meet the goal of vaccinating 20 million people in the next few days, he said.
Another 30 million doses will go out in January, Dr. Giroir said, followed by 50 million in February.
Some vaccine experts have said they’re not surprised by the speed of vaccine distribution.
“It had to go this way,” Paul Offit, MD, a professor of pediatrics at Children’s Hospital of Philadelphia, told STAT. “We had to trip and fall and stumble and figure this out.”
To speed up distribution in 2021, the federal government will need to help states, Mr. Biden said Dec. 29. He plans to use the Defense Authorization Act to ramp up production of vaccine supplies. Even still, the process will take months, he said.
A version of this article first appeared on WebMD.com .
New pediatric cases down as U.S. tops 2 million children with COVID-19
The United States exceeded 2 million reported cases of COVID-19 in children just 6 weeks after recording its 1 millionth case, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.
The total number of cases in children was 2,000,681 as of Dec. 24, which represents 12.4% of all cases reported by the health departments of 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam, the AAP and CHA stated Dec. 29.
The case count for just the latest week, 178,935, was actually down 1.7% from the 182,018 reported the week before, marking the second drop since the beginning of December. The first came during the week ending Dec. 3, when the number of cases dropped more than 19% from the previous week, based on data from the AAP/CHA report.
The cumulative national rate of coronavirus infection is now 2,658 cases per 100,000 children, and “13 states have reported more than 4,000 cases per 100,000,” the two groups said.
The highest rate for any state can be found in North Dakota, which has had 7,722 cases of COVID-19 per 100,000 children. Wyoming has the highest proportion of cases in children at 20.5%, and California has reported the most cases overall, 234,174, the report shows.
Data on testing, hospitalization, and mortality were not included in the Dec. 29 report because of the holiday but will be available in the next edition, scheduled for release on Jan. 5, 2021.
The United States exceeded 2 million reported cases of COVID-19 in children just 6 weeks after recording its 1 millionth case, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.
The total number of cases in children was 2,000,681 as of Dec. 24, which represents 12.4% of all cases reported by the health departments of 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam, the AAP and CHA stated Dec. 29.
The case count for just the latest week, 178,935, was actually down 1.7% from the 182,018 reported the week before, marking the second drop since the beginning of December. The first came during the week ending Dec. 3, when the number of cases dropped more than 19% from the previous week, based on data from the AAP/CHA report.
The cumulative national rate of coronavirus infection is now 2,658 cases per 100,000 children, and “13 states have reported more than 4,000 cases per 100,000,” the two groups said.
The highest rate for any state can be found in North Dakota, which has had 7,722 cases of COVID-19 per 100,000 children. Wyoming has the highest proportion of cases in children at 20.5%, and California has reported the most cases overall, 234,174, the report shows.
Data on testing, hospitalization, and mortality were not included in the Dec. 29 report because of the holiday but will be available in the next edition, scheduled for release on Jan. 5, 2021.
The United States exceeded 2 million reported cases of COVID-19 in children just 6 weeks after recording its 1 millionth case, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.
The total number of cases in children was 2,000,681 as of Dec. 24, which represents 12.4% of all cases reported by the health departments of 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam, the AAP and CHA stated Dec. 29.
The case count for just the latest week, 178,935, was actually down 1.7% from the 182,018 reported the week before, marking the second drop since the beginning of December. The first came during the week ending Dec. 3, when the number of cases dropped more than 19% from the previous week, based on data from the AAP/CHA report.
The cumulative national rate of coronavirus infection is now 2,658 cases per 100,000 children, and “13 states have reported more than 4,000 cases per 100,000,” the two groups said.
The highest rate for any state can be found in North Dakota, which has had 7,722 cases of COVID-19 per 100,000 children. Wyoming has the highest proportion of cases in children at 20.5%, and California has reported the most cases overall, 234,174, the report shows.
Data on testing, hospitalization, and mortality were not included in the Dec. 29 report because of the holiday but will be available in the next edition, scheduled for release on Jan. 5, 2021.
Patients with cancer a ‘high priority’ for COVID-19 vaccine, says AACR task force
“The available evidence supports the conclusion that patients with cancer, in particular with hematologic malignancies, should be considered among the high-risk groups for priority COVID-19 vaccination,” according to the AACR’s COVID-19 and Cancer Task Force.
A review of literature suggested that COVID-19 fatality rates for patients with cancer were double that of individuals without cancer, the team noted. The higher mortality rates still trended upward, even after adjusting for confounders including age, sex, and comorbidities, indicating that there is a greater risk for severe disease and COVID-19–related mortality.
The new AACR position paper was published online Dec. 19 in Cancer Discovery.
“We conclude that patients with an active cancer should be considered for priority access to COVID-19 vaccination, along other particularly vulnerable populations with risk factors for adverse outcomes with COVID-19,” the team wrote.
However, the authors noted that “it is unclear whether this recommendation should be applicable to patients with a past diagnosis of cancer, as cancer survivors can be considered having the same risk as other persons with matched age and other risk factors.
“Given that there are nearly 17 million people living with a history of cancer in the United States alone, it is critical to understand whether these individuals are at a higher risk to contract SARS-COV-2 and to experience severe outcomes from COVID-19,” they added.
Allocation of initial doses
There has already been much discussion on the allocation of the initial doses of COVID-19 vaccines that have become available in the United States. The Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention recommended that the first wave of vaccinations, described as phase 1a, should be administered to health care workers (about 21 million people) and residents of long-term care facilities (about 3 million).
The next priority group, phase 1b, should consist of frontline essential workers, a group of about 30 million, and adults aged 75 years or older, a group of about 21 million. When overlap between the groups is taken into account, phase 1b covers about 49 million people, according to the CDC.
Finally, phase 1c, the third priority group, would include adults aged 65-74 years (a group of about 32 million), adults aged 16-64 years with high-risk medical conditions (a group of about 110 million), and essential workers who did not qualify for inclusion in phase 1b (a group of about 57 million). With the overlap, Phase 1c would cover about 129 million people.
The AACR task force, led by Antoni Ribas, MD, PhD, of the Jonsson Comprehensive Cancer Center at the University of California, Los Angeles, noted in their position paper that their recommendation is consistent with ACIP’s guidelines. Those guidelines concluded that patients with cancer are at a higher risk for severe COVID-19, and should be one of the groups considered for early COVID-19 vaccination.
Questions remain
Approached for independent comment, Cardinale Smith, MD, PhD, chief quality officer for cancer services for the Mount Sinai Health System in New York, agreed with the AACR task force. “I share that they should be high priority,” she said, “But we don’t know that the efficacy will the same.”
Dr. Smith noted that the impact of cancer therapy on patient immune systems is more related to the type of treatment they’re receiving, and B- and T-cell responses. “But regardless, they should be getting the vaccine, and we just need to follow the guidelines.”
The AACR task force noted that information thus far is quite limited as to the effects of COVID-19 vaccination in patients with cancer. In the Pfizer-BioNTech BNT162b2 COVID vaccine trial, of 43,540 participants, only 3.7% were reported to have cancer. Other large COVID-19 vaccine trials will provide further follow-up information on the effectiveness of the vaccines in patients receiving different cancer treatments, they wrote, but for now, there is “currently not enough data to evaluate the interactions between active oncologic therapy with the ability to induce protective immunity” to COVID-19 with vaccination.
In a recent interview, Nora Disis, MD, a medical oncologist and director of both the Institute of Translational Health Sciences and the Cancer Vaccine Institute, University of Washington, Seattle, also discussed vaccinating cancer patients.
She pointed out that even though there are data suggesting that cancer patients are at higher risk, “they are a bit murky, in part because cancer patients are a heterogeneous group.”
“For example, there are data suggesting that lung and blood cancer patients fare worse,” said Dr. Disis, who is also editor in chief of JAMA Oncology. “There is also a suggestion that, like in the general population, COVID risk in cancer patients remains driven by comorbidities.”
She also pointed out the likelihood that individualized risk factors, including the type of cancer therapy, site of disease, and comorbidities, “will shape individual choices about vaccination among cancer patients.”
It is also reasonable to expect that patients with cancer will respond to the vaccines, even though historically some believed that they would be unable to mount an immune response. “Data on other viral vaccines have shown otherwise,” said Dr. Disis. “For example, there has been a long history of studies of flu vaccination in cancer patients, and in general, those vaccines confer protection.”
Several of the authors of the AACR position paper, including Dr. Ribas, reported relationships with industry as detailed in the paper. Dr. Smith has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
“The available evidence supports the conclusion that patients with cancer, in particular with hematologic malignancies, should be considered among the high-risk groups for priority COVID-19 vaccination,” according to the AACR’s COVID-19 and Cancer Task Force.
A review of literature suggested that COVID-19 fatality rates for patients with cancer were double that of individuals without cancer, the team noted. The higher mortality rates still trended upward, even after adjusting for confounders including age, sex, and comorbidities, indicating that there is a greater risk for severe disease and COVID-19–related mortality.
The new AACR position paper was published online Dec. 19 in Cancer Discovery.
“We conclude that patients with an active cancer should be considered for priority access to COVID-19 vaccination, along other particularly vulnerable populations with risk factors for adverse outcomes with COVID-19,” the team wrote.
However, the authors noted that “it is unclear whether this recommendation should be applicable to patients with a past diagnosis of cancer, as cancer survivors can be considered having the same risk as other persons with matched age and other risk factors.
“Given that there are nearly 17 million people living with a history of cancer in the United States alone, it is critical to understand whether these individuals are at a higher risk to contract SARS-COV-2 and to experience severe outcomes from COVID-19,” they added.
Allocation of initial doses
There has already been much discussion on the allocation of the initial doses of COVID-19 vaccines that have become available in the United States. The Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention recommended that the first wave of vaccinations, described as phase 1a, should be administered to health care workers (about 21 million people) and residents of long-term care facilities (about 3 million).
The next priority group, phase 1b, should consist of frontline essential workers, a group of about 30 million, and adults aged 75 years or older, a group of about 21 million. When overlap between the groups is taken into account, phase 1b covers about 49 million people, according to the CDC.
Finally, phase 1c, the third priority group, would include adults aged 65-74 years (a group of about 32 million), adults aged 16-64 years with high-risk medical conditions (a group of about 110 million), and essential workers who did not qualify for inclusion in phase 1b (a group of about 57 million). With the overlap, Phase 1c would cover about 129 million people.
The AACR task force, led by Antoni Ribas, MD, PhD, of the Jonsson Comprehensive Cancer Center at the University of California, Los Angeles, noted in their position paper that their recommendation is consistent with ACIP’s guidelines. Those guidelines concluded that patients with cancer are at a higher risk for severe COVID-19, and should be one of the groups considered for early COVID-19 vaccination.
Questions remain
Approached for independent comment, Cardinale Smith, MD, PhD, chief quality officer for cancer services for the Mount Sinai Health System in New York, agreed with the AACR task force. “I share that they should be high priority,” she said, “But we don’t know that the efficacy will the same.”
Dr. Smith noted that the impact of cancer therapy on patient immune systems is more related to the type of treatment they’re receiving, and B- and T-cell responses. “But regardless, they should be getting the vaccine, and we just need to follow the guidelines.”
The AACR task force noted that information thus far is quite limited as to the effects of COVID-19 vaccination in patients with cancer. In the Pfizer-BioNTech BNT162b2 COVID vaccine trial, of 43,540 participants, only 3.7% were reported to have cancer. Other large COVID-19 vaccine trials will provide further follow-up information on the effectiveness of the vaccines in patients receiving different cancer treatments, they wrote, but for now, there is “currently not enough data to evaluate the interactions between active oncologic therapy with the ability to induce protective immunity” to COVID-19 with vaccination.
In a recent interview, Nora Disis, MD, a medical oncologist and director of both the Institute of Translational Health Sciences and the Cancer Vaccine Institute, University of Washington, Seattle, also discussed vaccinating cancer patients.
She pointed out that even though there are data suggesting that cancer patients are at higher risk, “they are a bit murky, in part because cancer patients are a heterogeneous group.”
“For example, there are data suggesting that lung and blood cancer patients fare worse,” said Dr. Disis, who is also editor in chief of JAMA Oncology. “There is also a suggestion that, like in the general population, COVID risk in cancer patients remains driven by comorbidities.”
She also pointed out the likelihood that individualized risk factors, including the type of cancer therapy, site of disease, and comorbidities, “will shape individual choices about vaccination among cancer patients.”
It is also reasonable to expect that patients with cancer will respond to the vaccines, even though historically some believed that they would be unable to mount an immune response. “Data on other viral vaccines have shown otherwise,” said Dr. Disis. “For example, there has been a long history of studies of flu vaccination in cancer patients, and in general, those vaccines confer protection.”
Several of the authors of the AACR position paper, including Dr. Ribas, reported relationships with industry as detailed in the paper. Dr. Smith has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
“The available evidence supports the conclusion that patients with cancer, in particular with hematologic malignancies, should be considered among the high-risk groups for priority COVID-19 vaccination,” according to the AACR’s COVID-19 and Cancer Task Force.
A review of literature suggested that COVID-19 fatality rates for patients with cancer were double that of individuals without cancer, the team noted. The higher mortality rates still trended upward, even after adjusting for confounders including age, sex, and comorbidities, indicating that there is a greater risk for severe disease and COVID-19–related mortality.
The new AACR position paper was published online Dec. 19 in Cancer Discovery.
“We conclude that patients with an active cancer should be considered for priority access to COVID-19 vaccination, along other particularly vulnerable populations with risk factors for adverse outcomes with COVID-19,” the team wrote.
However, the authors noted that “it is unclear whether this recommendation should be applicable to patients with a past diagnosis of cancer, as cancer survivors can be considered having the same risk as other persons with matched age and other risk factors.
“Given that there are nearly 17 million people living with a history of cancer in the United States alone, it is critical to understand whether these individuals are at a higher risk to contract SARS-COV-2 and to experience severe outcomes from COVID-19,” they added.
Allocation of initial doses
There has already been much discussion on the allocation of the initial doses of COVID-19 vaccines that have become available in the United States. The Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention recommended that the first wave of vaccinations, described as phase 1a, should be administered to health care workers (about 21 million people) and residents of long-term care facilities (about 3 million).
The next priority group, phase 1b, should consist of frontline essential workers, a group of about 30 million, and adults aged 75 years or older, a group of about 21 million. When overlap between the groups is taken into account, phase 1b covers about 49 million people, according to the CDC.
Finally, phase 1c, the third priority group, would include adults aged 65-74 years (a group of about 32 million), adults aged 16-64 years with high-risk medical conditions (a group of about 110 million), and essential workers who did not qualify for inclusion in phase 1b (a group of about 57 million). With the overlap, Phase 1c would cover about 129 million people.
The AACR task force, led by Antoni Ribas, MD, PhD, of the Jonsson Comprehensive Cancer Center at the University of California, Los Angeles, noted in their position paper that their recommendation is consistent with ACIP’s guidelines. Those guidelines concluded that patients with cancer are at a higher risk for severe COVID-19, and should be one of the groups considered for early COVID-19 vaccination.
Questions remain
Approached for independent comment, Cardinale Smith, MD, PhD, chief quality officer for cancer services for the Mount Sinai Health System in New York, agreed with the AACR task force. “I share that they should be high priority,” she said, “But we don’t know that the efficacy will the same.”
Dr. Smith noted that the impact of cancer therapy on patient immune systems is more related to the type of treatment they’re receiving, and B- and T-cell responses. “But regardless, they should be getting the vaccine, and we just need to follow the guidelines.”
The AACR task force noted that information thus far is quite limited as to the effects of COVID-19 vaccination in patients with cancer. In the Pfizer-BioNTech BNT162b2 COVID vaccine trial, of 43,540 participants, only 3.7% were reported to have cancer. Other large COVID-19 vaccine trials will provide further follow-up information on the effectiveness of the vaccines in patients receiving different cancer treatments, they wrote, but for now, there is “currently not enough data to evaluate the interactions between active oncologic therapy with the ability to induce protective immunity” to COVID-19 with vaccination.
In a recent interview, Nora Disis, MD, a medical oncologist and director of both the Institute of Translational Health Sciences and the Cancer Vaccine Institute, University of Washington, Seattle, also discussed vaccinating cancer patients.
She pointed out that even though there are data suggesting that cancer patients are at higher risk, “they are a bit murky, in part because cancer patients are a heterogeneous group.”
“For example, there are data suggesting that lung and blood cancer patients fare worse,” said Dr. Disis, who is also editor in chief of JAMA Oncology. “There is also a suggestion that, like in the general population, COVID risk in cancer patients remains driven by comorbidities.”
She also pointed out the likelihood that individualized risk factors, including the type of cancer therapy, site of disease, and comorbidities, “will shape individual choices about vaccination among cancer patients.”
It is also reasonable to expect that patients with cancer will respond to the vaccines, even though historically some believed that they would be unable to mount an immune response. “Data on other viral vaccines have shown otherwise,” said Dr. Disis. “For example, there has been a long history of studies of flu vaccination in cancer patients, and in general, those vaccines confer protection.”
Several of the authors of the AACR position paper, including Dr. Ribas, reported relationships with industry as detailed in the paper. Dr. Smith has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.