Business of Medicine

A Plan B vending machine in Boston is gaining attention as reproductive rights have come into question since the Supreme Court overturned Roe v. Wade.

A group of students at Boston University installed the vending machine to dispense emergency contraception at a lower cost for students, according to NBC Boston. Plan B, also known as the morning-after pill, is a form of emergency contraception that can prevent pregnancy after unprotected sex or when another birth control method may have failed.

The vending machine is next to other vending machines filled with drinks and snacks in the basement of the student union at Boston University, NBC Boston reported. The machine contains boxes of levonorgestrel, a generic version of Plan B.

The boxes sell for $7.25, and the machine accepts all major credit cards. The charges are listed as “vending and snacks” on bank statements.

The Students for Reproductive Freedom decided to install the machine after seeing a similar one at Brandeis University, the news outlet reported. The vending machine was installed in March and has sold more than 1,000 emergency contraception pills. Students can also access emergency contraception through the university’s Student Health Services, which orders the contraception for the machine.

“We just wanted something that was low-cost and easy to access,” Charlotte Beatty, former copresident of Students for Reproductive Freedom, told NBC Boston.

“You don’t need to take a train across town. You don’t need to call a doctor,” she said. “It’s right there, and you can get it as soon as you need it.”

The demand for emergency contraception has increased since the Supreme Court overturned Roe. Some retailers have placed limits on how many units can be purchased at one time.

“The overturning of Roe made us even more proud to offer this service to people in our community,” Molly Baker, the group’s other former copresident, told NBC Boston.

Pictures of the vending machine have recently gone viral on social media.

“It’s going viral because people are scared, and this is a solution,” Rebecca Hart Holder, executive director of Reproductive Equity Now, told the news station.

Reproductive Equity Now, a reproductive health care nonprofit in Boston, recently honored the Boston University student group at its annual gala. Although emergency contraception is still legal, people are concerned about the effect that overturning Roe may have on future contraception access cases, Ms. Hart Holder said.

“We have to be fighting and planning for a nation that would restrict access to birth control, which is a terrifying thing to say,” she said.

The Boston University student group is now helping students at other schools who want a Plan B vending machine, and they published a resource guide to help others. They hope to install more machines on their campus and stock them with different types of medication in the future.

Plan B contains a high dose of progestin, a synthetic form of the hormone progesterone, which helps to regulate the menstrual cycle, according to Today. The pill works by inhibiting or delaying ovulation and can be taken within 72 hours after unprotected sex, though it’s most effective when taken within 24 hours. Plan B doesn’t cause an abortion and has no effect on an existing pregnancy.

Plan B and its generic versions can be purchased over the counter at most pharmacies and ordered online from major retailers. Plan B typically costs $40-$50, while generic versions cost $11-$45.
 

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

A Plan B vending machine in Boston is gaining attention as reproductive rights have come into question since the Supreme Court overturned Roe v. Wade.

A group of students at Boston University installed the vending machine to dispense emergency contraception at a lower cost for students, according to NBC Boston. Plan B, also known as the morning-after pill, is a form of emergency contraception that can prevent pregnancy after unprotected sex or when another birth control method may have failed.

The vending machine is next to other vending machines filled with drinks and snacks in the basement of the student union at Boston University, NBC Boston reported. The machine contains boxes of levonorgestrel, a generic version of Plan B.

The boxes sell for $7.25, and the machine accepts all major credit cards. The charges are listed as “vending and snacks” on bank statements.

The Students for Reproductive Freedom decided to install the machine after seeing a similar one at Brandeis University, the news outlet reported. The vending machine was installed in March and has sold more than 1,000 emergency contraception pills. Students can also access emergency contraception through the university’s Student Health Services, which orders the contraception for the machine.

“We just wanted something that was low-cost and easy to access,” Charlotte Beatty, former copresident of Students for Reproductive Freedom, told NBC Boston.

“You don’t need to take a train across town. You don’t need to call a doctor,” she said. “It’s right there, and you can get it as soon as you need it.”

The demand for emergency contraception has increased since the Supreme Court overturned Roe. Some retailers have placed limits on how many units can be purchased at one time.

“The overturning of Roe made us even more proud to offer this service to people in our community,” Molly Baker, the group’s other former copresident, told NBC Boston.

Pictures of the vending machine have recently gone viral on social media.

“It’s going viral because people are scared, and this is a solution,” Rebecca Hart Holder, executive director of Reproductive Equity Now, told the news station.

Reproductive Equity Now, a reproductive health care nonprofit in Boston, recently honored the Boston University student group at its annual gala. Although emergency contraception is still legal, people are concerned about the effect that overturning Roe may have on future contraception access cases, Ms. Hart Holder said.

“We have to be fighting and planning for a nation that would restrict access to birth control, which is a terrifying thing to say,” she said.

The Boston University student group is now helping students at other schools who want a Plan B vending machine, and they published a resource guide to help others. They hope to install more machines on their campus and stock them with different types of medication in the future.

Plan B contains a high dose of progestin, a synthetic form of the hormone progesterone, which helps to regulate the menstrual cycle, according to Today. The pill works by inhibiting or delaying ovulation and can be taken within 72 hours after unprotected sex, though it’s most effective when taken within 24 hours. Plan B doesn’t cause an abortion and has no effect on an existing pregnancy.

Plan B and its generic versions can be purchased over the counter at most pharmacies and ordered online from major retailers. Plan B typically costs $40-$50, while generic versions cost $11-$45.
 

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

A Plan B vending machine in Boston is gaining attention as reproductive rights have come into question since the Supreme Court overturned Roe v. Wade.

A group of students at Boston University installed the vending machine to dispense emergency contraception at a lower cost for students, according to NBC Boston. Plan B, also known as the morning-after pill, is a form of emergency contraception that can prevent pregnancy after unprotected sex or when another birth control method may have failed.

The vending machine is next to other vending machines filled with drinks and snacks in the basement of the student union at Boston University, NBC Boston reported. The machine contains boxes of levonorgestrel, a generic version of Plan B.

The boxes sell for $7.25, and the machine accepts all major credit cards. The charges are listed as “vending and snacks” on bank statements.

The Students for Reproductive Freedom decided to install the machine after seeing a similar one at Brandeis University, the news outlet reported. The vending machine was installed in March and has sold more than 1,000 emergency contraception pills. Students can also access emergency contraception through the university’s Student Health Services, which orders the contraception for the machine.

“We just wanted something that was low-cost and easy to access,” Charlotte Beatty, former copresident of Students for Reproductive Freedom, told NBC Boston.

“You don’t need to take a train across town. You don’t need to call a doctor,” she said. “It’s right there, and you can get it as soon as you need it.”

The demand for emergency contraception has increased since the Supreme Court overturned Roe. Some retailers have placed limits on how many units can be purchased at one time.

“The overturning of Roe made us even more proud to offer this service to people in our community,” Molly Baker, the group’s other former copresident, told NBC Boston.

Pictures of the vending machine have recently gone viral on social media.

“It’s going viral because people are scared, and this is a solution,” Rebecca Hart Holder, executive director of Reproductive Equity Now, told the news station.

Reproductive Equity Now, a reproductive health care nonprofit in Boston, recently honored the Boston University student group at its annual gala. Although emergency contraception is still legal, people are concerned about the effect that overturning Roe may have on future contraception access cases, Ms. Hart Holder said.

“We have to be fighting and planning for a nation that would restrict access to birth control, which is a terrifying thing to say,” she said.

The Boston University student group is now helping students at other schools who want a Plan B vending machine, and they published a resource guide to help others. They hope to install more machines on their campus and stock them with different types of medication in the future.

Plan B contains a high dose of progestin, a synthetic form of the hormone progesterone, which helps to regulate the menstrual cycle, according to Today. The pill works by inhibiting or delaying ovulation and can be taken within 72 hours after unprotected sex, though it’s most effective when taken within 24 hours. Plan B doesn’t cause an abortion and has no effect on an existing pregnancy.

Plan B and its generic versions can be purchased over the counter at most pharmacies and ordered online from major retailers. Plan B typically costs $40-$50, while generic versions cost $11-$45.
 

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

When I began in private practice several eons ago, I employed only registered nurses (RNs) and licensed practical nurses (LPNs) in my office – as did, I think, most other physicians.

That is still the preferred way to go from an efficiency perspective, as well as the ability to delegate such tasks as blood collection and administering intramuscular injections. Unfortunately, the current state of medical practice – driven by payment reform, regulatory changes, technology costs, inflation, and other factors – has forced most independent practitioners to pivot from RNs and LPNs to medical assistants in a majority of situations.

Given this reality, it makes sense to understand how the use of medical assistants has changed private medical practice, and how the most effective MAs manage their roles and maximize their efficiency in the office.

A recent article by two physicians at the University of Michigan, Ann Arbor, is one of the few published papers to address this issue. It presents the results of a cross-sectional study examining the MA’s experience and key factors that enhance or reduce efficiencies.

The authors sent an email survey to 86 MAs working in six clinics within the department of family medicine at the University of Michigan Medical Center, and received responses from 75 of them, including 61 who completed the entire survey. They then singled out 18 individuals deemed “most efficient” by their peers and conducted face-to-face interviews with them.

The surveys and interviews looked at how MAs identified personal strategies for efficiency, dealt with barriers to implementing those strategies, and navigated interoffice relationships, as well as how all of this affected overall job satisfaction.

All 61 respondents who completed the full survey agreed that the MA role was “very important to keep the clinic functioning” and nearly all said that working in health care was “a calling” for them. About half agreed that their work was very stressful, and about the same percentage reported that there was inadequate MA staffing at their clinic. Others complained of limited pay and promotion opportunities.

The surveyed MAs described important work values that increased their efficiency. These included good communication, strong teamwork, and workload sharing, as well as individual strategies such as multitasking, limiting patient conversations, and completing tasks in a consistent way to improve accuracy.

Other strategies identified as contributing to an efficient operation included preclinic huddles, reviews of patient records before the patient’s arrival, and completing routine office duties before the start of office hours.

Respondents were then asked to identify barriers to clinic efficiency, and most of them involved physicians who barked orders at them, did not complete paperwork or sign orders in a timely manner, and agreed to see late-arriving patients. Some MAs suggested that physicians refrain from “talking down” to them, and teach rather than criticize. They also faulted decisions affecting patient flow made by other staffers without soliciting the MAs’ input.

Despite these barriers, the authors found that most of the surveyed MAs agreed that their work was valued by doctors. “Proper training of managers to provide ... support and ensure equitable workloads may be one strategy to ensure that staff members feel the workplace is fair and collegial,” they said.

“Many described the working relationships with physicians as critical to their satisfaction at work and indicated that strong partnerships motivated them to do their best to make the physician’s day easier,” they added.

At the same time, the authors noted that most survey subjects reported that their jobs were “stressful,” and believed that their stress went underrecognized by physicians. They argued that “it’s important for physicians to be cognizant of these patterns and clinic culture, as reducing a hierarchy-based environment will be appreciated by MAs.”

Since this study involved only MAs in a family practice setting, further studies will be needed to determine whether these results translate to specialty offices – and whether the unique issues inherent in various specialty environments elicit different efficiency contributors and barriers.

Overall, though, “staff job satisfaction is linked to improved quality of care, so treating staff well contributes to high-value care for patients,” the authors wrote. “Disseminating practices that staff members themselves have identified as effective, and being attentive to how staff members are treated, may increase individual efficiency while improving staff retention and satisfaction.”

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@mdedge.com.

When I began in private practice several eons ago, I employed only registered nurses (RNs) and licensed practical nurses (LPNs) in my office – as did, I think, most other physicians.

That is still the preferred way to go from an efficiency perspective, as well as the ability to delegate such tasks as blood collection and administering intramuscular injections. Unfortunately, the current state of medical practice – driven by payment reform, regulatory changes, technology costs, inflation, and other factors – has forced most independent practitioners to pivot from RNs and LPNs to medical assistants in a majority of situations.

Given this reality, it makes sense to understand how the use of medical assistants has changed private medical practice, and how the most effective MAs manage their roles and maximize their efficiency in the office.

A recent article by two physicians at the University of Michigan, Ann Arbor, is one of the few published papers to address this issue. It presents the results of a cross-sectional study examining the MA’s experience and key factors that enhance or reduce efficiencies.

The authors sent an email survey to 86 MAs working in six clinics within the department of family medicine at the University of Michigan Medical Center, and received responses from 75 of them, including 61 who completed the entire survey. They then singled out 18 individuals deemed “most efficient” by their peers and conducted face-to-face interviews with them.

The surveys and interviews looked at how MAs identified personal strategies for efficiency, dealt with barriers to implementing those strategies, and navigated interoffice relationships, as well as how all of this affected overall job satisfaction.

All 61 respondents who completed the full survey agreed that the MA role was “very important to keep the clinic functioning” and nearly all said that working in health care was “a calling” for them. About half agreed that their work was very stressful, and about the same percentage reported that there was inadequate MA staffing at their clinic. Others complained of limited pay and promotion opportunities.

The surveyed MAs described important work values that increased their efficiency. These included good communication, strong teamwork, and workload sharing, as well as individual strategies such as multitasking, limiting patient conversations, and completing tasks in a consistent way to improve accuracy.

Other strategies identified as contributing to an efficient operation included preclinic huddles, reviews of patient records before the patient’s arrival, and completing routine office duties before the start of office hours.

Respondents were then asked to identify barriers to clinic efficiency, and most of them involved physicians who barked orders at them, did not complete paperwork or sign orders in a timely manner, and agreed to see late-arriving patients. Some MAs suggested that physicians refrain from “talking down” to them, and teach rather than criticize. They also faulted decisions affecting patient flow made by other staffers without soliciting the MAs’ input.

Despite these barriers, the authors found that most of the surveyed MAs agreed that their work was valued by doctors. “Proper training of managers to provide ... support and ensure equitable workloads may be one strategy to ensure that staff members feel the workplace is fair and collegial,” they said.

“Many described the working relationships with physicians as critical to their satisfaction at work and indicated that strong partnerships motivated them to do their best to make the physician’s day easier,” they added.

At the same time, the authors noted that most survey subjects reported that their jobs were “stressful,” and believed that their stress went underrecognized by physicians. They argued that “it’s important for physicians to be cognizant of these patterns and clinic culture, as reducing a hierarchy-based environment will be appreciated by MAs.”

Since this study involved only MAs in a family practice setting, further studies will be needed to determine whether these results translate to specialty offices – and whether the unique issues inherent in various specialty environments elicit different efficiency contributors and barriers.

Overall, though, “staff job satisfaction is linked to improved quality of care, so treating staff well contributes to high-value care for patients,” the authors wrote. “Disseminating practices that staff members themselves have identified as effective, and being attentive to how staff members are treated, may increase individual efficiency while improving staff retention and satisfaction.”

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@mdedge.com.

When I began in private practice several eons ago, I employed only registered nurses (RNs) and licensed practical nurses (LPNs) in my office – as did, I think, most other physicians.

That is still the preferred way to go from an efficiency perspective, as well as the ability to delegate such tasks as blood collection and administering intramuscular injections. Unfortunately, the current state of medical practice – driven by payment reform, regulatory changes, technology costs, inflation, and other factors – has forced most independent practitioners to pivot from RNs and LPNs to medical assistants in a majority of situations.

Given this reality, it makes sense to understand how the use of medical assistants has changed private medical practice, and how the most effective MAs manage their roles and maximize their efficiency in the office.

A recent article by two physicians at the University of Michigan, Ann Arbor, is one of the few published papers to address this issue. It presents the results of a cross-sectional study examining the MA’s experience and key factors that enhance or reduce efficiencies.

The authors sent an email survey to 86 MAs working in six clinics within the department of family medicine at the University of Michigan Medical Center, and received responses from 75 of them, including 61 who completed the entire survey. They then singled out 18 individuals deemed “most efficient” by their peers and conducted face-to-face interviews with them.

The surveys and interviews looked at how MAs identified personal strategies for efficiency, dealt with barriers to implementing those strategies, and navigated interoffice relationships, as well as how all of this affected overall job satisfaction.

All 61 respondents who completed the full survey agreed that the MA role was “very important to keep the clinic functioning” and nearly all said that working in health care was “a calling” for them. About half agreed that their work was very stressful, and about the same percentage reported that there was inadequate MA staffing at their clinic. Others complained of limited pay and promotion opportunities.

The surveyed MAs described important work values that increased their efficiency. These included good communication, strong teamwork, and workload sharing, as well as individual strategies such as multitasking, limiting patient conversations, and completing tasks in a consistent way to improve accuracy.

Other strategies identified as contributing to an efficient operation included preclinic huddles, reviews of patient records before the patient’s arrival, and completing routine office duties before the start of office hours.

Respondents were then asked to identify barriers to clinic efficiency, and most of them involved physicians who barked orders at them, did not complete paperwork or sign orders in a timely manner, and agreed to see late-arriving patients. Some MAs suggested that physicians refrain from “talking down” to them, and teach rather than criticize. They also faulted decisions affecting patient flow made by other staffers without soliciting the MAs’ input.

Despite these barriers, the authors found that most of the surveyed MAs agreed that their work was valued by doctors. “Proper training of managers to provide ... support and ensure equitable workloads may be one strategy to ensure that staff members feel the workplace is fair and collegial,” they said.

“Many described the working relationships with physicians as critical to their satisfaction at work and indicated that strong partnerships motivated them to do their best to make the physician’s day easier,” they added.

At the same time, the authors noted that most survey subjects reported that their jobs were “stressful,” and believed that their stress went underrecognized by physicians. They argued that “it’s important for physicians to be cognizant of these patterns and clinic culture, as reducing a hierarchy-based environment will be appreciated by MAs.”

Since this study involved only MAs in a family practice setting, further studies will be needed to determine whether these results translate to specialty offices – and whether the unique issues inherent in various specialty environments elicit different efficiency contributors and barriers.

Overall, though, “staff job satisfaction is linked to improved quality of care, so treating staff well contributes to high-value care for patients,” the authors wrote. “Disseminating practices that staff members themselves have identified as effective, and being attentive to how staff members are treated, may increase individual efficiency while improving staff retention and satisfaction.”

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@mdedge.com.

MUSCATINE, IOWA – Bailee Tordai, who was 33 weeks into her pregnancy, barely made it to the prenatal checkup. Her clunky old Jeep couldn’t complete the 2-mile trip from her house to the University of Iowa’s outreach clinic in her southeastern Iowa hometown. It was a hot June day, and a wiring problem made the Jeep conk out in the street.

A passerby helped Ms.Tordai, 22, push her stricken vehicle off the road and into a parking lot. Then she called her stepdad for a ride to the clinic.

Jaclyn Roman, a nurse-midwife, walked into the exam room. “I heard your car broke down.”

“Yup. You want to buy it? Five bucks!” Ms. Tordai joked.

Her lack of reliable transportation won’t be a laughing matter in August, when her baby is due. She will need to arrange for someone to drive her about 40 miles northwest to the University of Iowa Hospitals and Clinics in Iowa City. She can’t give birth at Muscatine’s hospital because it shuttered its birthing unit in 2020.

Ms. Roman is part of an unusual effort to minimize the harm caused by such closures. She’s one of 11 certified nurse-midwives from the University of Iowa who travel regularly to Muscatine and Washington, another southeastern Iowa town where the local hospital closed its birthing unit. The university’s pilot project, which is supported by a federal grant, doesn’t aim to reopen shuttered birthing units. Instead, the midwife team helps ensure area women receive related services. Last year, it served more than 500 patients in Muscatine and Washington.

Muscatine is one of hundreds of rural areas in the United States where hospitals have dropped birthing services during the past 2 decades, often because they lack obstetricians and other specialized staff members.

Hospital industry leaders say birthing units also tend to lose money, largely because of low payments from Medicaid, the public health insurance program that covers more than 40% of births in the United States and an even greater share in many rural areas.

The loss of labor-and-delivery services hits especially hard for women who lack resources and time to travel for care.

Muscatine, which is on the Mississippi River, has more than 23,000 residents, making it a relatively large town by Iowa standards. But its hospital is one of 41 Iowa facilities that have closed their birthing units since 2000, according to the Iowa Department of Public Health. Most were in rural areas. Just one has reopened, and only 56 Iowa hospitals now have birthing units.

The nurse-midwife team’s work includes crucial prenatal checkups. Most pregnant people are supposed to have a dozen or more such appointments before giving birth. Health care providers use the checkups to track how a pregnancy is progressing and to watch for signs of high blood pressure and other problems that can lead to premature births, stillbirths, or even maternal deaths. The midwives also advise women on how to keep themselves and their babies healthy after birth.

Karen Jefferson, DM, director of midwifery practice for the American College of Nurse-Midwives, said the University of Iowa team’s approach is an innovative way to address needs in rural areas that have lost hospital birthing units. “How wonderful would it be to see a provider in your town, instead of driving 40 miles for your prenatal visits – especially toward the end of pregnancy, when you’re going every week,” said Dr. Jefferson, who lives in rural New York.

Midwives can provide many other types of care for women and for babies. In theory, they could even open rural birthing centers outside of hospitals, Dr. Jefferson said. But they would need to overcome concerns about financing and about the availability of surgeons to do emergency cesarean sections, which she said are rarely needed in low-risk births.

The University of Iowa midwives focus on low-risk pregnancies, referring patients with significant health issues to physician specialists in Iowa City. Often, those specialists can visit with the patients and the midwives via video conference in the small-town clinics.

The loss of a hospital obstetrics unit can make finding local maternity care harder for rural families.

Ms. Tordai can attest that if patients must travel far for prenatal appointments, they’re less likely to get to them all. If she had to go to Iowa City for each of hers, repeatedly taking 3 hours off from her job managing a pizza restaurant would be tough, she said. On that June day her Jeep broke down, she would have canceled her appointment.

Instead, she wound up on an exam table at the Muscatine clinic listening to her baby’s heartbeat on a monitor and watching as Ms. Roman measured her belly.

“Nice job being perfect,” the midwife told her during the checkup.

Ms. Roman asked Ms. Tordai to describe her baby’s movements. “Constant,” she replied with a smile.

Ms. Roman asked whether she planned to breastfeed. Ms. Tordai said she didn’t have much luck with her first daughter, Aspen, now 4.

“Have you thought about a breastfeeding class?” the midwife asked.

“I don’t have time for that,” Ms. Tordai replied. Ms. Roman continued to coax her, noting where a breastfeeding class is available online.

Near the end of the appointment, Ms. Tordai asked Ms. Roman whether she could schedule an induced birth at the University of Iowa hospital. The midwife told her that, in general, letting labor begin on its own is better than artificially starting it.

But there was the matter of unreliable transportation. Ms. Tordai explained that scheduling the birth would help her arrange to have her mother drive her to the hospital in Iowa City. Ms. Roman agreed that transportation is a legitimate reason and arranged for an induced labor on Aug. 10.

The University of Iowa midwife team started offering services in 2020 in a clinic about 2 miles from Trinity Muscatine hospital. The hospital is owned by UnityPoint Health, a large nonprofit hospital system that blamed a lack of available obstetricians for the closure of the Muscatine birthing unit. At the time, UnityPoint leaders said they hoped to reopen the unit if they could recruit new obstetricians to the area.

Kristy Phillipson, a UnityPoint Health spokesperson, told KHN in June that the company has continued to try to recruit physicians, including for the Muscatine hospital. Although it has not reopened the birthing unit, the company regularly sends an obstetrician and other staff members to provide prenatal care and related services, she said.

Most pregnant patients from the area who choose UnityPoint for their care wind up giving birth at the system’s hospital in Bettendorf, a 45-minute drive to the east.

The University of Iowa midwife team has no plans to open its own birthing centers, but it hopes to expand its rural clinic service to other underserved towns. To do so, the university would need to hire more nurse-midwives, which could be a challenge. According to the Iowa Board of Nursing, 120 licensed nurse-midwives live in the state of 3 million people.

The University of Iowa plans to address that by starting the state’s first nurse-midwife training program in 2023. The master’s degree program, which will emphasize rural service, will train registered nurses to become nurse-midwives. It eventually could graduate eight people per year, said Amber Goodrich, a University of Iowa midwife helping lead the effort.

Those graduates could fill gaps throughout rural areas, where even more hospitals may shutter their birthing units in the coming years.

“This crisis is going nowhere fast,” Ms. Goodrich said.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

MUSCATINE, IOWA – Bailee Tordai, who was 33 weeks into her pregnancy, barely made it to the prenatal checkup. Her clunky old Jeep couldn’t complete the 2-mile trip from her house to the University of Iowa’s outreach clinic in her southeastern Iowa hometown. It was a hot June day, and a wiring problem made the Jeep conk out in the street.

A passerby helped Ms.Tordai, 22, push her stricken vehicle off the road and into a parking lot. Then she called her stepdad for a ride to the clinic.

Jaclyn Roman, a nurse-midwife, walked into the exam room. “I heard your car broke down.”

“Yup. You want to buy it? Five bucks!” Ms. Tordai joked.

Her lack of reliable transportation won’t be a laughing matter in August, when her baby is due. She will need to arrange for someone to drive her about 40 miles northwest to the University of Iowa Hospitals and Clinics in Iowa City. She can’t give birth at Muscatine’s hospital because it shuttered its birthing unit in 2020.

Ms. Roman is part of an unusual effort to minimize the harm caused by such closures. She’s one of 11 certified nurse-midwives from the University of Iowa who travel regularly to Muscatine and Washington, another southeastern Iowa town where the local hospital closed its birthing unit. The university’s pilot project, which is supported by a federal grant, doesn’t aim to reopen shuttered birthing units. Instead, the midwife team helps ensure area women receive related services. Last year, it served more than 500 patients in Muscatine and Washington.

Muscatine is one of hundreds of rural areas in the United States where hospitals have dropped birthing services during the past 2 decades, often because they lack obstetricians and other specialized staff members.

Hospital industry leaders say birthing units also tend to lose money, largely because of low payments from Medicaid, the public health insurance program that covers more than 40% of births in the United States and an even greater share in many rural areas.

The loss of labor-and-delivery services hits especially hard for women who lack resources and time to travel for care.

Muscatine, which is on the Mississippi River, has more than 23,000 residents, making it a relatively large town by Iowa standards. But its hospital is one of 41 Iowa facilities that have closed their birthing units since 2000, according to the Iowa Department of Public Health. Most were in rural areas. Just one has reopened, and only 56 Iowa hospitals now have birthing units.

The nurse-midwife team’s work includes crucial prenatal checkups. Most pregnant people are supposed to have a dozen or more such appointments before giving birth. Health care providers use the checkups to track how a pregnancy is progressing and to watch for signs of high blood pressure and other problems that can lead to premature births, stillbirths, or even maternal deaths. The midwives also advise women on how to keep themselves and their babies healthy after birth.

Karen Jefferson, DM, director of midwifery practice for the American College of Nurse-Midwives, said the University of Iowa team’s approach is an innovative way to address needs in rural areas that have lost hospital birthing units. “How wonderful would it be to see a provider in your town, instead of driving 40 miles for your prenatal visits – especially toward the end of pregnancy, when you’re going every week,” said Dr. Jefferson, who lives in rural New York.

Midwives can provide many other types of care for women and for babies. In theory, they could even open rural birthing centers outside of hospitals, Dr. Jefferson said. But they would need to overcome concerns about financing and about the availability of surgeons to do emergency cesarean sections, which she said are rarely needed in low-risk births.

The University of Iowa midwives focus on low-risk pregnancies, referring patients with significant health issues to physician specialists in Iowa City. Often, those specialists can visit with the patients and the midwives via video conference in the small-town clinics.

The loss of a hospital obstetrics unit can make finding local maternity care harder for rural families.

Ms. Tordai can attest that if patients must travel far for prenatal appointments, they’re less likely to get to them all. If she had to go to Iowa City for each of hers, repeatedly taking 3 hours off from her job managing a pizza restaurant would be tough, she said. On that June day her Jeep broke down, she would have canceled her appointment.

Instead, she wound up on an exam table at the Muscatine clinic listening to her baby’s heartbeat on a monitor and watching as Ms. Roman measured her belly.

“Nice job being perfect,” the midwife told her during the checkup.

Ms. Roman asked Ms. Tordai to describe her baby’s movements. “Constant,” she replied with a smile.

Ms. Roman asked whether she planned to breastfeed. Ms. Tordai said she didn’t have much luck with her first daughter, Aspen, now 4.

“Have you thought about a breastfeeding class?” the midwife asked.

“I don’t have time for that,” Ms. Tordai replied. Ms. Roman continued to coax her, noting where a breastfeeding class is available online.

Near the end of the appointment, Ms. Tordai asked Ms. Roman whether she could schedule an induced birth at the University of Iowa hospital. The midwife told her that, in general, letting labor begin on its own is better than artificially starting it.

But there was the matter of unreliable transportation. Ms. Tordai explained that scheduling the birth would help her arrange to have her mother drive her to the hospital in Iowa City. Ms. Roman agreed that transportation is a legitimate reason and arranged for an induced labor on Aug. 10.

The University of Iowa midwife team started offering services in 2020 in a clinic about 2 miles from Trinity Muscatine hospital. The hospital is owned by UnityPoint Health, a large nonprofit hospital system that blamed a lack of available obstetricians for the closure of the Muscatine birthing unit. At the time, UnityPoint leaders said they hoped to reopen the unit if they could recruit new obstetricians to the area.

Kristy Phillipson, a UnityPoint Health spokesperson, told KHN in June that the company has continued to try to recruit physicians, including for the Muscatine hospital. Although it has not reopened the birthing unit, the company regularly sends an obstetrician and other staff members to provide prenatal care and related services, she said.

Most pregnant patients from the area who choose UnityPoint for their care wind up giving birth at the system’s hospital in Bettendorf, a 45-minute drive to the east.

The University of Iowa midwife team has no plans to open its own birthing centers, but it hopes to expand its rural clinic service to other underserved towns. To do so, the university would need to hire more nurse-midwives, which could be a challenge. According to the Iowa Board of Nursing, 120 licensed nurse-midwives live in the state of 3 million people.

The University of Iowa plans to address that by starting the state’s first nurse-midwife training program in 2023. The master’s degree program, which will emphasize rural service, will train registered nurses to become nurse-midwives. It eventually could graduate eight people per year, said Amber Goodrich, a University of Iowa midwife helping lead the effort.

Those graduates could fill gaps throughout rural areas, where even more hospitals may shutter their birthing units in the coming years.

“This crisis is going nowhere fast,” Ms. Goodrich said.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

MUSCATINE, IOWA – Bailee Tordai, who was 33 weeks into her pregnancy, barely made it to the prenatal checkup. Her clunky old Jeep couldn’t complete the 2-mile trip from her house to the University of Iowa’s outreach clinic in her southeastern Iowa hometown. It was a hot June day, and a wiring problem made the Jeep conk out in the street.

A passerby helped Ms.Tordai, 22, push her stricken vehicle off the road and into a parking lot. Then she called her stepdad for a ride to the clinic.

Jaclyn Roman, a nurse-midwife, walked into the exam room. “I heard your car broke down.”

“Yup. You want to buy it? Five bucks!” Ms. Tordai joked.

Her lack of reliable transportation won’t be a laughing matter in August, when her baby is due. She will need to arrange for someone to drive her about 40 miles northwest to the University of Iowa Hospitals and Clinics in Iowa City. She can’t give birth at Muscatine’s hospital because it shuttered its birthing unit in 2020.

Ms. Roman is part of an unusual effort to minimize the harm caused by such closures. She’s one of 11 certified nurse-midwives from the University of Iowa who travel regularly to Muscatine and Washington, another southeastern Iowa town where the local hospital closed its birthing unit. The university’s pilot project, which is supported by a federal grant, doesn’t aim to reopen shuttered birthing units. Instead, the midwife team helps ensure area women receive related services. Last year, it served more than 500 patients in Muscatine and Washington.

Muscatine is one of hundreds of rural areas in the United States where hospitals have dropped birthing services during the past 2 decades, often because they lack obstetricians and other specialized staff members.

Hospital industry leaders say birthing units also tend to lose money, largely because of low payments from Medicaid, the public health insurance program that covers more than 40% of births in the United States and an even greater share in many rural areas.

The loss of labor-and-delivery services hits especially hard for women who lack resources and time to travel for care.

Muscatine, which is on the Mississippi River, has more than 23,000 residents, making it a relatively large town by Iowa standards. But its hospital is one of 41 Iowa facilities that have closed their birthing units since 2000, according to the Iowa Department of Public Health. Most were in rural areas. Just one has reopened, and only 56 Iowa hospitals now have birthing units.

The nurse-midwife team’s work includes crucial prenatal checkups. Most pregnant people are supposed to have a dozen or more such appointments before giving birth. Health care providers use the checkups to track how a pregnancy is progressing and to watch for signs of high blood pressure and other problems that can lead to premature births, stillbirths, or even maternal deaths. The midwives also advise women on how to keep themselves and their babies healthy after birth.

Karen Jefferson, DM, director of midwifery practice for the American College of Nurse-Midwives, said the University of Iowa team’s approach is an innovative way to address needs in rural areas that have lost hospital birthing units. “How wonderful would it be to see a provider in your town, instead of driving 40 miles for your prenatal visits – especially toward the end of pregnancy, when you’re going every week,” said Dr. Jefferson, who lives in rural New York.

Midwives can provide many other types of care for women and for babies. In theory, they could even open rural birthing centers outside of hospitals, Dr. Jefferson said. But they would need to overcome concerns about financing and about the availability of surgeons to do emergency cesarean sections, which she said are rarely needed in low-risk births.

The University of Iowa midwives focus on low-risk pregnancies, referring patients with significant health issues to physician specialists in Iowa City. Often, those specialists can visit with the patients and the midwives via video conference in the small-town clinics.

The loss of a hospital obstetrics unit can make finding local maternity care harder for rural families.

Ms. Tordai can attest that if patients must travel far for prenatal appointments, they’re less likely to get to them all. If she had to go to Iowa City for each of hers, repeatedly taking 3 hours off from her job managing a pizza restaurant would be tough, she said. On that June day her Jeep broke down, she would have canceled her appointment.

Instead, she wound up on an exam table at the Muscatine clinic listening to her baby’s heartbeat on a monitor and watching as Ms. Roman measured her belly.

“Nice job being perfect,” the midwife told her during the checkup.

Ms. Roman asked Ms. Tordai to describe her baby’s movements. “Constant,” she replied with a smile.

Ms. Roman asked whether she planned to breastfeed. Ms. Tordai said she didn’t have much luck with her first daughter, Aspen, now 4.

“Have you thought about a breastfeeding class?” the midwife asked.

“I don’t have time for that,” Ms. Tordai replied. Ms. Roman continued to coax her, noting where a breastfeeding class is available online.

Near the end of the appointment, Ms. Tordai asked Ms. Roman whether she could schedule an induced birth at the University of Iowa hospital. The midwife told her that, in general, letting labor begin on its own is better than artificially starting it.

But there was the matter of unreliable transportation. Ms. Tordai explained that scheduling the birth would help her arrange to have her mother drive her to the hospital in Iowa City. Ms. Roman agreed that transportation is a legitimate reason and arranged for an induced labor on Aug. 10.

The University of Iowa midwife team started offering services in 2020 in a clinic about 2 miles from Trinity Muscatine hospital. The hospital is owned by UnityPoint Health, a large nonprofit hospital system that blamed a lack of available obstetricians for the closure of the Muscatine birthing unit. At the time, UnityPoint leaders said they hoped to reopen the unit if they could recruit new obstetricians to the area.

Kristy Phillipson, a UnityPoint Health spokesperson, told KHN in June that the company has continued to try to recruit physicians, including for the Muscatine hospital. Although it has not reopened the birthing unit, the company regularly sends an obstetrician and other staff members to provide prenatal care and related services, she said.

Most pregnant patients from the area who choose UnityPoint for their care wind up giving birth at the system’s hospital in Bettendorf, a 45-minute drive to the east.

The University of Iowa midwife team has no plans to open its own birthing centers, but it hopes to expand its rural clinic service to other underserved towns. To do so, the university would need to hire more nurse-midwives, which could be a challenge. According to the Iowa Board of Nursing, 120 licensed nurse-midwives live in the state of 3 million people.

The University of Iowa plans to address that by starting the state’s first nurse-midwife training program in 2023. The master’s degree program, which will emphasize rural service, will train registered nurses to become nurse-midwives. It eventually could graduate eight people per year, said Amber Goodrich, a University of Iowa midwife helping lead the effort.

Those graduates could fill gaps throughout rural areas, where even more hospitals may shutter their birthing units in the coming years.

“This crisis is going nowhere fast,” Ms. Goodrich said.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Just before he took a call from a reporter asking about the impact of drug shortages in hematology, Bill Greene, PharmD, chief pharmaceutical officer at St. Jude Children’s Research Hospital, had spent an hour on the phone overseeing his institution’s response to a hematology drug shortage. The chemotherapy drug fludarabine, used to treat chronic lymphocytic leukemia, was in short supply.

“There are 5 different manufacturers, but none of them have had drug available over the past 2 weeks,” Dr. Greene said. “We’re trying to chase some emergency supplies to be able to continue treatment for patients who’ve had their treatments initiated and planned.”

Over the past several years, this predicament has become common at hematology clinics across the country. In fact, management of scarce medication resources has become a significant part of Dr. Greene’s workload these days, as critical drugs fail to show up on time or manufacturer supplies run low at his hospital in Memphis.

This shortage of hematology drugs got a new dose of national attention, thanks to a recent episode of CBS News’ “60 Minutes.” Through interviews with physicians and parents of children who suddenly could not get vital medications, the report highlighted the recent shortage of another leukemia drug, vincristine.

“As a cancer mom, we shouldn’t be fighting for our children to get a drug that is needed,” Cyndi Valenta was quoted as saying. She recalled that when the shortage began in 2019, her 13-year-old son, a leukemia patient at Loma Linda (Calif.) University Hospital, felt frightened. Ms. Valenta said she felt a “gut-wrenching feeling of just fear and anger.” They were finally able to get doses of the drug after launching a social media campaign.

Such drug shortages are especially widespread in oncology and hematology, according to a survey of oncology pharmacists at 68 organizations nationwide. Published in the May 2022 issue of Oncology Practice, the study showed that 63% of institutions reported one or more drug shortages every month, with a 34% increase in 2019, compared with 2018. Treatment delays, reduced doses, or alternative regimens were reported by 75% of respondents, the authors wrote.

The pharmacists surveyed between May 2019 and July 2020 were asked about the three most hard-to-get chemotherapy and supportive care agents. Vincristine topped the list, followed by vinblastine, IVIG, leucovorin, and BCG, as well as difficult-to-obtain ropine, erwinia asparaginase, etoposide, and leuprolide. Several of these drugs are used to treat conditions such as lymphoma and leukemia.

Eighty-two percent of respondents reported shortages of decitabine (IV), often used as part of a cocktail with vinblastine and other drugs to treat Hodgkin lymphoma.

The reasons for drug shortages are varied. The CBS News report declared that “pharmaceutical companies have stopped producing many life-saving generic drugs because they make too little profit,” and it suggested that the federal government isn’t doing enough.

But government action actually might be making a difference. According to the FDA, the number of new drug shortages has fallen dramatically from 250 in 2011 to 41 in 2021, and the number of prevented drug shortages rose from nearly 200 to more than 300 over that same period. Still, the number of ongoing drug shortages has risen from around 40 in 2017 to about 80 in 2021.

Reasons for the paucity of certain drugs are often unclear. In a June 12, 2022 post, for example, the American Society of Health-System Pharmacists’ drug shortage database noted that the chemotherapy drug fludarabine was in short supply and provided details about when some of the 5 manufacturers expected to have it available. (This is the shortage that Dr. Greene was trying to manage.) But 4 of the 5 manufacturers “did not provide a reason,” and the fifth blamed manufacturing delays.

“There’s a lot of closely held trade secrets that hinder the ability to share good information,” said Dr. Greene. To make things more complicated, shipping times are often unreliable. “The product doesn’t show up today, we place another order. Sometimes it will show up tomorrow, sometimes it doesn’t,” he said. “If you’re not tracking it carefully, you deplete your own supply.”

Patients’ families have grown used to dealing with drug shortages, and “they’re less quick to blame personnel at our institution.”

How can hematologists cope with this issue? “The best thing in the immediate term is to advocate for their hospital to have a pharmacist dedicated to shortage monitoring and taking proactive steps to obviate shortages,” hematologist/oncologist Andrew Hantel, MD, an instructor at Dana-Farber Cancer Institute, Harvard Medical School, Boston, said in an interview.

“We have ongoing communications with other large cancer centers and the FDA to recognize shortages early and develop plans to make sure we stay ahead of them,” Dr. Hantel said. “Most often this involves assessing supply, use rates, alternative manufacturers, and additional measures the Food and Drug Administration can take (for example, importation), and occasionally working with clinical teams to see if other medications are feasible alternatives.”

If a drug is unavailable, it can also be helpful to discuss alternative approaches. “We did not have any frank shortages of vincristine,” Dr. Hantel said, “but we did focus on conservation measures and considered different ethically appropriate ways to distribute vincristine if there was a point at which we did not have enough for everyone who needed it.”

If a drug is in short supply, options can include delaying treatment, giving an alternative, or providing the rest of the regimen without the scarce drug, he said. In a 2021 report in The Lancet Hematology, Dr. Hantel and his colleagues offered “model solutions for ethical allocation during cancer medicine shortages.”

The authors of the May 2022 drug-shortage report highlighted an alternative regimen in hematology. They noted that manufacturing delays have limited the supply of dacarbazine, used for Hodgkin lymphoma. Due to the current shortages, they wrote, clinicians are considering the use of escalated bleomycin, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone, replacing dacarbazine with procarbazine and using the doxorubicin, bleomycin, vinblastine, procarbazine, and prednisone regimen, or replacing dacarbazine with cyclophosphamide.

Dr. Greene emphasized the importance of tracking the news and the drug shortage websites run by the FDA and the American Society of Health-System Pharmacists.

It’s also crucial to have a good relationship with your wholesaler, he added, and to communicate about these problems within your facility. At his hospital, the pharmaceutical staff holds a multi-disciplinary meeting at least weekly to discuss the supply of medications. As he put it, “it’s a challenging environment.”

Dr. Greene and Dr. Hantel reported no relevant disclosures.

Just before he took a call from a reporter asking about the impact of drug shortages in hematology, Bill Greene, PharmD, chief pharmaceutical officer at St. Jude Children’s Research Hospital, had spent an hour on the phone overseeing his institution’s response to a hematology drug shortage. The chemotherapy drug fludarabine, used to treat chronic lymphocytic leukemia, was in short supply.

“There are 5 different manufacturers, but none of them have had drug available over the past 2 weeks,” Dr. Greene said. “We’re trying to chase some emergency supplies to be able to continue treatment for patients who’ve had their treatments initiated and planned.”

Over the past several years, this predicament has become common at hematology clinics across the country. In fact, management of scarce medication resources has become a significant part of Dr. Greene’s workload these days, as critical drugs fail to show up on time or manufacturer supplies run low at his hospital in Memphis.

This shortage of hematology drugs got a new dose of national attention, thanks to a recent episode of CBS News’ “60 Minutes.” Through interviews with physicians and parents of children who suddenly could not get vital medications, the report highlighted the recent shortage of another leukemia drug, vincristine.

“As a cancer mom, we shouldn’t be fighting for our children to get a drug that is needed,” Cyndi Valenta was quoted as saying. She recalled that when the shortage began in 2019, her 13-year-old son, a leukemia patient at Loma Linda (Calif.) University Hospital, felt frightened. Ms. Valenta said she felt a “gut-wrenching feeling of just fear and anger.” They were finally able to get doses of the drug after launching a social media campaign.

Such drug shortages are especially widespread in oncology and hematology, according to a survey of oncology pharmacists at 68 organizations nationwide. Published in the May 2022 issue of Oncology Practice, the study showed that 63% of institutions reported one or more drug shortages every month, with a 34% increase in 2019, compared with 2018. Treatment delays, reduced doses, or alternative regimens were reported by 75% of respondents, the authors wrote.

The pharmacists surveyed between May 2019 and July 2020 were asked about the three most hard-to-get chemotherapy and supportive care agents. Vincristine topped the list, followed by vinblastine, IVIG, leucovorin, and BCG, as well as difficult-to-obtain ropine, erwinia asparaginase, etoposide, and leuprolide. Several of these drugs are used to treat conditions such as lymphoma and leukemia.

Eighty-two percent of respondents reported shortages of decitabine (IV), often used as part of a cocktail with vinblastine and other drugs to treat Hodgkin lymphoma.

The reasons for drug shortages are varied. The CBS News report declared that “pharmaceutical companies have stopped producing many life-saving generic drugs because they make too little profit,” and it suggested that the federal government isn’t doing enough.

But government action actually might be making a difference. According to the FDA, the number of new drug shortages has fallen dramatically from 250 in 2011 to 41 in 2021, and the number of prevented drug shortages rose from nearly 200 to more than 300 over that same period. Still, the number of ongoing drug shortages has risen from around 40 in 2017 to about 80 in 2021.

Reasons for the paucity of certain drugs are often unclear. In a June 12, 2022 post, for example, the American Society of Health-System Pharmacists’ drug shortage database noted that the chemotherapy drug fludarabine was in short supply and provided details about when some of the 5 manufacturers expected to have it available. (This is the shortage that Dr. Greene was trying to manage.) But 4 of the 5 manufacturers “did not provide a reason,” and the fifth blamed manufacturing delays.

“There’s a lot of closely held trade secrets that hinder the ability to share good information,” said Dr. Greene. To make things more complicated, shipping times are often unreliable. “The product doesn’t show up today, we place another order. Sometimes it will show up tomorrow, sometimes it doesn’t,” he said. “If you’re not tracking it carefully, you deplete your own supply.”

Patients’ families have grown used to dealing with drug shortages, and “they’re less quick to blame personnel at our institution.”

How can hematologists cope with this issue? “The best thing in the immediate term is to advocate for their hospital to have a pharmacist dedicated to shortage monitoring and taking proactive steps to obviate shortages,” hematologist/oncologist Andrew Hantel, MD, an instructor at Dana-Farber Cancer Institute, Harvard Medical School, Boston, said in an interview.

“We have ongoing communications with other large cancer centers and the FDA to recognize shortages early and develop plans to make sure we stay ahead of them,” Dr. Hantel said. “Most often this involves assessing supply, use rates, alternative manufacturers, and additional measures the Food and Drug Administration can take (for example, importation), and occasionally working with clinical teams to see if other medications are feasible alternatives.”

If a drug is unavailable, it can also be helpful to discuss alternative approaches. “We did not have any frank shortages of vincristine,” Dr. Hantel said, “but we did focus on conservation measures and considered different ethically appropriate ways to distribute vincristine if there was a point at which we did not have enough for everyone who needed it.”

If a drug is in short supply, options can include delaying treatment, giving an alternative, or providing the rest of the regimen without the scarce drug, he said. In a 2021 report in The Lancet Hematology, Dr. Hantel and his colleagues offered “model solutions for ethical allocation during cancer medicine shortages.”

The authors of the May 2022 drug-shortage report highlighted an alternative regimen in hematology. They noted that manufacturing delays have limited the supply of dacarbazine, used for Hodgkin lymphoma. Due to the current shortages, they wrote, clinicians are considering the use of escalated bleomycin, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone, replacing dacarbazine with procarbazine and using the doxorubicin, bleomycin, vinblastine, procarbazine, and prednisone regimen, or replacing dacarbazine with cyclophosphamide.

Dr. Greene emphasized the importance of tracking the news and the drug shortage websites run by the FDA and the American Society of Health-System Pharmacists.

It’s also crucial to have a good relationship with your wholesaler, he added, and to communicate about these problems within your facility. At his hospital, the pharmaceutical staff holds a multi-disciplinary meeting at least weekly to discuss the supply of medications. As he put it, “it’s a challenging environment.”

Dr. Greene and Dr. Hantel reported no relevant disclosures.

Just before he took a call from a reporter asking about the impact of drug shortages in hematology, Bill Greene, PharmD, chief pharmaceutical officer at St. Jude Children’s Research Hospital, had spent an hour on the phone overseeing his institution’s response to a hematology drug shortage. The chemotherapy drug fludarabine, used to treat chronic lymphocytic leukemia, was in short supply.

“There are 5 different manufacturers, but none of them have had drug available over the past 2 weeks,” Dr. Greene said. “We’re trying to chase some emergency supplies to be able to continue treatment for patients who’ve had their treatments initiated and planned.”

Over the past several years, this predicament has become common at hematology clinics across the country. In fact, management of scarce medication resources has become a significant part of Dr. Greene’s workload these days, as critical drugs fail to show up on time or manufacturer supplies run low at his hospital in Memphis.

This shortage of hematology drugs got a new dose of national attention, thanks to a recent episode of CBS News’ “60 Minutes.” Through interviews with physicians and parents of children who suddenly could not get vital medications, the report highlighted the recent shortage of another leukemia drug, vincristine.

“As a cancer mom, we shouldn’t be fighting for our children to get a drug that is needed,” Cyndi Valenta was quoted as saying. She recalled that when the shortage began in 2019, her 13-year-old son, a leukemia patient at Loma Linda (Calif.) University Hospital, felt frightened. Ms. Valenta said she felt a “gut-wrenching feeling of just fear and anger.” They were finally able to get doses of the drug after launching a social media campaign.

Such drug shortages are especially widespread in oncology and hematology, according to a survey of oncology pharmacists at 68 organizations nationwide. Published in the May 2022 issue of Oncology Practice, the study showed that 63% of institutions reported one or more drug shortages every month, with a 34% increase in 2019, compared with 2018. Treatment delays, reduced doses, or alternative regimens were reported by 75% of respondents, the authors wrote.

The pharmacists surveyed between May 2019 and July 2020 were asked about the three most hard-to-get chemotherapy and supportive care agents. Vincristine topped the list, followed by vinblastine, IVIG, leucovorin, and BCG, as well as difficult-to-obtain ropine, erwinia asparaginase, etoposide, and leuprolide. Several of these drugs are used to treat conditions such as lymphoma and leukemia.

Eighty-two percent of respondents reported shortages of decitabine (IV), often used as part of a cocktail with vinblastine and other drugs to treat Hodgkin lymphoma.

The reasons for drug shortages are varied. The CBS News report declared that “pharmaceutical companies have stopped producing many life-saving generic drugs because they make too little profit,” and it suggested that the federal government isn’t doing enough.

But government action actually might be making a difference. According to the FDA, the number of new drug shortages has fallen dramatically from 250 in 2011 to 41 in 2021, and the number of prevented drug shortages rose from nearly 200 to more than 300 over that same period. Still, the number of ongoing drug shortages has risen from around 40 in 2017 to about 80 in 2021.

Reasons for the paucity of certain drugs are often unclear. In a June 12, 2022 post, for example, the American Society of Health-System Pharmacists’ drug shortage database noted that the chemotherapy drug fludarabine was in short supply and provided details about when some of the 5 manufacturers expected to have it available. (This is the shortage that Dr. Greene was trying to manage.) But 4 of the 5 manufacturers “did not provide a reason,” and the fifth blamed manufacturing delays.

“There’s a lot of closely held trade secrets that hinder the ability to share good information,” said Dr. Greene. To make things more complicated, shipping times are often unreliable. “The product doesn’t show up today, we place another order. Sometimes it will show up tomorrow, sometimes it doesn’t,” he said. “If you’re not tracking it carefully, you deplete your own supply.”

Patients’ families have grown used to dealing with drug shortages, and “they’re less quick to blame personnel at our institution.”

How can hematologists cope with this issue? “The best thing in the immediate term is to advocate for their hospital to have a pharmacist dedicated to shortage monitoring and taking proactive steps to obviate shortages,” hematologist/oncologist Andrew Hantel, MD, an instructor at Dana-Farber Cancer Institute, Harvard Medical School, Boston, said in an interview.

“We have ongoing communications with other large cancer centers and the FDA to recognize shortages early and develop plans to make sure we stay ahead of them,” Dr. Hantel said. “Most often this involves assessing supply, use rates, alternative manufacturers, and additional measures the Food and Drug Administration can take (for example, importation), and occasionally working with clinical teams to see if other medications are feasible alternatives.”

If a drug is unavailable, it can also be helpful to discuss alternative approaches. “We did not have any frank shortages of vincristine,” Dr. Hantel said, “but we did focus on conservation measures and considered different ethically appropriate ways to distribute vincristine if there was a point at which we did not have enough for everyone who needed it.”

If a drug is in short supply, options can include delaying treatment, giving an alternative, or providing the rest of the regimen without the scarce drug, he said. In a 2021 report in The Lancet Hematology, Dr. Hantel and his colleagues offered “model solutions for ethical allocation during cancer medicine shortages.”

The authors of the May 2022 drug-shortage report highlighted an alternative regimen in hematology. They noted that manufacturing delays have limited the supply of dacarbazine, used for Hodgkin lymphoma. Due to the current shortages, they wrote, clinicians are considering the use of escalated bleomycin, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone, replacing dacarbazine with procarbazine and using the doxorubicin, bleomycin, vinblastine, procarbazine, and prednisone regimen, or replacing dacarbazine with cyclophosphamide.

Dr. Greene emphasized the importance of tracking the news and the drug shortage websites run by the FDA and the American Society of Health-System Pharmacists.

It’s also crucial to have a good relationship with your wholesaler, he added, and to communicate about these problems within your facility. At his hospital, the pharmaceutical staff holds a multi-disciplinary meeting at least weekly to discuss the supply of medications. As he put it, “it’s a challenging environment.”

Dr. Greene and Dr. Hantel reported no relevant disclosures.

Barbara L. McAneny, MD, CEO of New Mexico Oncology Hematology Consultants, experienced a data breach about 10 years ago, when a laptop was stolen from her large practice.   

She and the other physicians were upset and worried that the individual would attempt to log in to the computer system and hack their patients’ private health information.

Dr. McAneny was also worried that the practice would have to pay a hefty fine to the government for having unsecured private health information on a laptop. She could have paid from $50,000 to more than $1.9 million for lost and stolen devices (although that didn’t happen).

Dr. McAneny had a standard cyber liability benefit in her med-mal policy that covered up to $50,000 of the data breach costs. That covered the legal advice The Doctors Company provided about state and federal reporting requirements when a data breach occurs and the costs the practice incurred from mailing letters to all of its patients notifying them of the data breach, says Dr. McAneny.

“The data breach taught me a lot. Our practice spent a lot of money on increasing our internal controls, cybersecurity, and monitoring. Our IT department started testing our computer firewalls periodically, and that’s how we discovered that cybercriminals were attempting to break into our computer system at least 100 times daily,” says Dr. McAneny.

That discovery changed how she thought about insurance. “I decided the med-mal benefit wasn’t enough. I bought the best cybersecurity policy we could afford to protect against future breaches, especially malware or ransomware attacks.” 

Her practice also had to make its electronic health records (EHRs) more secure to comply with the Department of Health & Human Services Office of Civil Rights standards for protected health information. The cost of increased security wasn’t covered by her cyber benefit.
 

Cyberattacks increasing in health care

Despite having comprehensive coverage, Dr. McAneny worries that the cybercriminals are a step ahead of the cybersecurity experts and her practice will eventually have another data breach.

“The policy only covers things that we know about today. As we upgrade our defenses, criminals are finding new ways to breach firewalls and work around our defenses,” she says.

Cybercriminals – whether from foreign countries or just plain, homegrown thugs – have stepped up their attacks on health care organizations. So far this year, nearly 200 medical groups have reported cyberattacks involving 500 or more of their patients’ medical records to the federal government.

EHRs are valuable targets to cybercriminals because of the protected health information they contain. Cybercriminals grab information such as Social Security numbers, dates of birth, medical procedures and results, and in some cases billing and financial information and sell it on the dark web.

They typically bundle the information and sell it to other criminals who later use it for various kinds of fraud and extortion such as banking and credit fraud, health care fraud, identity theft, and ransom extortion.
 

What do most doctors have?

The vast majority (82%) of doctors polled by the Medical Group Management Association last year said they had cyber insurance, compared with 54% in 2018.

For those who answered “yes,” many said they have coverage through their malpractice insurance carrier.

David Zetter, president of Zetter HealthCare Management Consultants, recommends that physicians speak with their malpractice carrier to determine what coverage they have, if any, within their malpractice policy. 

A typical cybersecurity benefit is limited to what is needed to fix and resolve the hacking incident, says Raj Shah, senior regulatory attorney and policyholder advisor at MagMutual, which insures medical practices for malpractice and cyber liability.

That usually covers investigating the cause of the breach and the extent of the damage, legal advice about federal and state reporting requirements, whether to pay a ransom, and a public relations professional to handle patient communication, says Mr. Shah.

The benefit doesn’t cover lost patient revenue when practices have to shut down their operations, the cost of replacing damaged computers, or the ransom payment, he says.

Mr. Zetter advises doctors to consider buying cybersecurity coverage. “I recommend that they speak with an insurance broker who is experienced with cybersecurity policies sold to health care professionals to determine what type of coverage and how much coverage they may need. Their malpractice carrier may also be able to provide some answers,” says Mr. Zetter.

The physician will need to be able to answer questions about their network and how many staff they have and may need to involve their IT vendor too, he adds.
 

How does comprehensive coverage compare?

Ransomware attacks continue to be one of the most frequent types of attacks, and the amount criminals are demanding has risen significantly. The median ransom payment was $5,000 in the fourth quarter of 2018, compared with over $300,000 during the  fourth quarter of 2021.

Cybercriminals now engage in “double extortion” – demanding a ransom payment to hand over the code that will unlock their encrypted data – and then another ransom payment to not post patients’ sensitive medical information they copied onto the dark web.

Comprehensive cybersecurity insurance will cover “double extortion” payments, legal costs that may arise from defending against patient lawsuits, and the costs of meeting federal and state privacy requirements, including notifying patients of the data breach and regulatory investigations, says Michael Carr, head of risk engineering for North America for Coalition, a cyber insurance firm.  

Cyber insurers also contract with vendors who sell bitcoin, which is the currency cybercriminals typically demand for ransom payments, and work with ransom negotiators.

For example, once Coalition decided to pay the ransom on behalf of a health care client, it negotiated the ransom demand down by nearly 75% from $750,000 to $200,000, and proceeded to help the company restore all of its data.

The costs to respond to the incident, to recover lost data, and to pay the extortion, together with the lost business income resulting from the incident, were covered by Coalition’s cyber insurance policy.

Other clients have had their funds retrieved before a fraudulent wire transfer was completed. “Medical practices have vendors they pay regularly. A cybercriminal may compromise your email or take over a bank account and then impersonate a vendor asking to be paid for services they didn’t provide,” says Mr. Carr.
 

How much coverage do you need? Cost?

Dr. McAneny has increased her cybersecurity coverage every year. “It’s expensive, but I think it’s worth it. But you can never buy enough protection due to the coverage limits.”

She worries that the costs could exceed the limits if a ransomware attack disrupts her practice for days, weeks, or longer, or if the Office for Civil Rights fines her practice $10,000 per patient chart – the practice has 100,000 health records. “That can run several millions of dollars and ruin a practice,” she says.

Health systems and hospitals need massive amounts of coverage, which often runs from $20 million to $30 million, says Mr. Shah. However, practices insured through MagMutual have lower coverage limits that range from $1 million to $5 million, he says.

“A large practice does not necessarily need more than $1,000,000 in coverage if they have limited loss in this area and strong internal processes and controls. Most large practices also have a dedicated information security director, which reduces their risk, so they may be comfortable with $1,000,000 in coverage,” says Mr. Shah.

Premiums are based on the number of patient health records per practice, which translates into higher premiums for larger practices.

Other factors that come into play include the underlying coverage, risk controls the practice has implemented, and its claims history, says Mr. Shah.

However, the cost for cyber liability insurance has increased, and practices can expect to pay higher premiums and deductibles. For example, a practice that paid $10,000 in premiums for a new policy last year will have to pay $20,000 this year, says Dan Hanson, senior vice president of management liability and client experience at Marsh & McLennon Agency, a risk management firm that sells cyber insurance policies.

“We saw 71% of our self-insured clients experience higher deductibles over last year due to increased claim activity and the lack of capacity in the market. The carriers are saying they will set limits, but you are going to pay a lot more, and you are going to participate more in losses through the higher deductibles,” says Mr. Hanson.
 

Are you eligible?

Cyber insurance companies have a vested interest in avoiding claims. With increasing cyberattacks and larger payouts, many insurers are requiring practices to implement some defensive measures before they insure them. Some insurers, such as Coalition, say they may still insure small practices for comprehensive coverage, but it may impact the pricing or what’s covered, says Mr. Carr.  

Here are some of the security measures that cyber insurers are looking for:

• Multifactorial authentication (MFA) requires an extra layer of security to access the system. For example, when logging into your organization’s EHR platform, instead of just using a username and password to access the platform, MFA would require you to input an additional unique login credential before you can access the EHR. A secondary login credential may include security questions, a one-time PIN, or biometrics.
• Removing a terminated employee’s login credentials quickly from the computer system. “One of the most damaging and expensive types of attacks are by disgruntled employees who still have their login credentials and take revenge by logging back into the system and planting malware,” says Mr. Shah.
• Automatic system updates (patches). “Phishing email compromises usually result from a failure to fix vulnerabilities. When a system needs to restart, it should be set to automatically update any potential security loopholes within programs or products,” says Mr. Carr. The firewall settings should also be updated.
• Prior hacking incidents: Are the attackers out of your system? Once criminals hack into the system, your practice is vulnerable to repeat attacks. “If a cyberattack is not completely addressed, threat actors will maintain access to or a presence on the compromised network. In general, we will work with the insured to ensure that the initial point of compromise has been addressed and that any threat actor presence in the network has been removed,” says Mr. Carr.

When doctors compare cybersecurity policies, experts recommend avoiding companies that may offer lower prices but lack a proven track record of handling claims and do not offer resources that can detect a threat, such as ongoing network monitoring and employee training with simulated exercises.

“Practices tend to think, ‘It won’t happen to me.’ Every practice needs to take this seriously,” says Dr. McAneny.

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

Barbara L. McAneny, MD, CEO of New Mexico Oncology Hematology Consultants, experienced a data breach about 10 years ago, when a laptop was stolen from her large practice.   

She and the other physicians were upset and worried that the individual would attempt to log in to the computer system and hack their patients’ private health information.

Dr. McAneny was also worried that the practice would have to pay a hefty fine to the government for having unsecured private health information on a laptop. She could have paid from $50,000 to more than $1.9 million for lost and stolen devices (although that didn’t happen).

Dr. McAneny had a standard cyber liability benefit in her med-mal policy that covered up to $50,000 of the data breach costs. That covered the legal advice The Doctors Company provided about state and federal reporting requirements when a data breach occurs and the costs the practice incurred from mailing letters to all of its patients notifying them of the data breach, says Dr. McAneny.

“The data breach taught me a lot. Our practice spent a lot of money on increasing our internal controls, cybersecurity, and monitoring. Our IT department started testing our computer firewalls periodically, and that’s how we discovered that cybercriminals were attempting to break into our computer system at least 100 times daily,” says Dr. McAneny.

That discovery changed how she thought about insurance. “I decided the med-mal benefit wasn’t enough. I bought the best cybersecurity policy we could afford to protect against future breaches, especially malware or ransomware attacks.” 

Her practice also had to make its electronic health records (EHRs) more secure to comply with the Department of Health & Human Services Office of Civil Rights standards for protected health information. The cost of increased security wasn’t covered by her cyber benefit.
 

Cyberattacks increasing in health care

Despite having comprehensive coverage, Dr. McAneny worries that the cybercriminals are a step ahead of the cybersecurity experts and her practice will eventually have another data breach.

“The policy only covers things that we know about today. As we upgrade our defenses, criminals are finding new ways to breach firewalls and work around our defenses,” she says.

Cybercriminals – whether from foreign countries or just plain, homegrown thugs – have stepped up their attacks on health care organizations. So far this year, nearly 200 medical groups have reported cyberattacks involving 500 or more of their patients’ medical records to the federal government.

EHRs are valuable targets to cybercriminals because of the protected health information they contain. Cybercriminals grab information such as Social Security numbers, dates of birth, medical procedures and results, and in some cases billing and financial information and sell it on the dark web.

They typically bundle the information and sell it to other criminals who later use it for various kinds of fraud and extortion such as banking and credit fraud, health care fraud, identity theft, and ransom extortion.
 

What do most doctors have?

The vast majority (82%) of doctors polled by the Medical Group Management Association last year said they had cyber insurance, compared with 54% in 2018.

For those who answered “yes,” many said they have coverage through their malpractice insurance carrier.

David Zetter, president of Zetter HealthCare Management Consultants, recommends that physicians speak with their malpractice carrier to determine what coverage they have, if any, within their malpractice policy. 

A typical cybersecurity benefit is limited to what is needed to fix and resolve the hacking incident, says Raj Shah, senior regulatory attorney and policyholder advisor at MagMutual, which insures medical practices for malpractice and cyber liability.

That usually covers investigating the cause of the breach and the extent of the damage, legal advice about federal and state reporting requirements, whether to pay a ransom, and a public relations professional to handle patient communication, says Mr. Shah.

The benefit doesn’t cover lost patient revenue when practices have to shut down their operations, the cost of replacing damaged computers, or the ransom payment, he says.

Mr. Zetter advises doctors to consider buying cybersecurity coverage. “I recommend that they speak with an insurance broker who is experienced with cybersecurity policies sold to health care professionals to determine what type of coverage and how much coverage they may need. Their malpractice carrier may also be able to provide some answers,” says Mr. Zetter.

The physician will need to be able to answer questions about their network and how many staff they have and may need to involve their IT vendor too, he adds.
 

How does comprehensive coverage compare?

Ransomware attacks continue to be one of the most frequent types of attacks, and the amount criminals are demanding has risen significantly. The median ransom payment was $5,000 in the fourth quarter of 2018, compared with over $300,000 during the  fourth quarter of 2021.

Cybercriminals now engage in “double extortion” – demanding a ransom payment to hand over the code that will unlock their encrypted data – and then another ransom payment to not post patients’ sensitive medical information they copied onto the dark web.

Comprehensive cybersecurity insurance will cover “double extortion” payments, legal costs that may arise from defending against patient lawsuits, and the costs of meeting federal and state privacy requirements, including notifying patients of the data breach and regulatory investigations, says Michael Carr, head of risk engineering for North America for Coalition, a cyber insurance firm.  

Cyber insurers also contract with vendors who sell bitcoin, which is the currency cybercriminals typically demand for ransom payments, and work with ransom negotiators.

For example, once Coalition decided to pay the ransom on behalf of a health care client, it negotiated the ransom demand down by nearly 75% from $750,000 to $200,000, and proceeded to help the company restore all of its data.

The costs to respond to the incident, to recover lost data, and to pay the extortion, together with the lost business income resulting from the incident, were covered by Coalition’s cyber insurance policy.

Other clients have had their funds retrieved before a fraudulent wire transfer was completed. “Medical practices have vendors they pay regularly. A cybercriminal may compromise your email or take over a bank account and then impersonate a vendor asking to be paid for services they didn’t provide,” says Mr. Carr.
 

How much coverage do you need? Cost?

Dr. McAneny has increased her cybersecurity coverage every year. “It’s expensive, but I think it’s worth it. But you can never buy enough protection due to the coverage limits.”

She worries that the costs could exceed the limits if a ransomware attack disrupts her practice for days, weeks, or longer, or if the Office for Civil Rights fines her practice $10,000 per patient chart – the practice has 100,000 health records. “That can run several millions of dollars and ruin a practice,” she says.

Health systems and hospitals need massive amounts of coverage, which often runs from $20 million to $30 million, says Mr. Shah. However, practices insured through MagMutual have lower coverage limits that range from $1 million to $5 million, he says.

“A large practice does not necessarily need more than $1,000,000 in coverage if they have limited loss in this area and strong internal processes and controls. Most large practices also have a dedicated information security director, which reduces their risk, so they may be comfortable with $1,000,000 in coverage,” says Mr. Shah.

Premiums are based on the number of patient health records per practice, which translates into higher premiums for larger practices.

Other factors that come into play include the underlying coverage, risk controls the practice has implemented, and its claims history, says Mr. Shah.

However, the cost for cyber liability insurance has increased, and practices can expect to pay higher premiums and deductibles. For example, a practice that paid $10,000 in premiums for a new policy last year will have to pay $20,000 this year, says Dan Hanson, senior vice president of management liability and client experience at Marsh & McLennon Agency, a risk management firm that sells cyber insurance policies.

“We saw 71% of our self-insured clients experience higher deductibles over last year due to increased claim activity and the lack of capacity in the market. The carriers are saying they will set limits, but you are going to pay a lot more, and you are going to participate more in losses through the higher deductibles,” says Mr. Hanson.
 

Are you eligible?

Cyber insurance companies have a vested interest in avoiding claims. With increasing cyberattacks and larger payouts, many insurers are requiring practices to implement some defensive measures before they insure them. Some insurers, such as Coalition, say they may still insure small practices for comprehensive coverage, but it may impact the pricing or what’s covered, says Mr. Carr.  

Here are some of the security measures that cyber insurers are looking for:

• Multifactorial authentication (MFA) requires an extra layer of security to access the system. For example, when logging into your organization’s EHR platform, instead of just using a username and password to access the platform, MFA would require you to input an additional unique login credential before you can access the EHR. A secondary login credential may include security questions, a one-time PIN, or biometrics.
• Removing a terminated employee’s login credentials quickly from the computer system. “One of the most damaging and expensive types of attacks are by disgruntled employees who still have their login credentials and take revenge by logging back into the system and planting malware,” says Mr. Shah.
• Automatic system updates (patches). “Phishing email compromises usually result from a failure to fix vulnerabilities. When a system needs to restart, it should be set to automatically update any potential security loopholes within programs or products,” says Mr. Carr. The firewall settings should also be updated.
• Prior hacking incidents: Are the attackers out of your system? Once criminals hack into the system, your practice is vulnerable to repeat attacks. “If a cyberattack is not completely addressed, threat actors will maintain access to or a presence on the compromised network. In general, we will work with the insured to ensure that the initial point of compromise has been addressed and that any threat actor presence in the network has been removed,” says Mr. Carr.

When doctors compare cybersecurity policies, experts recommend avoiding companies that may offer lower prices but lack a proven track record of handling claims and do not offer resources that can detect a threat, such as ongoing network monitoring and employee training with simulated exercises.

“Practices tend to think, ‘It won’t happen to me.’ Every practice needs to take this seriously,” says Dr. McAneny.

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

Barbara L. McAneny, MD, CEO of New Mexico Oncology Hematology Consultants, experienced a data breach about 10 years ago, when a laptop was stolen from her large practice.   

She and the other physicians were upset and worried that the individual would attempt to log in to the computer system and hack their patients’ private health information.

Dr. McAneny was also worried that the practice would have to pay a hefty fine to the government for having unsecured private health information on a laptop. She could have paid from $50,000 to more than $1.9 million for lost and stolen devices (although that didn’t happen).

Dr. McAneny had a standard cyber liability benefit in her med-mal policy that covered up to $50,000 of the data breach costs. That covered the legal advice The Doctors Company provided about state and federal reporting requirements when a data breach occurs and the costs the practice incurred from mailing letters to all of its patients notifying them of the data breach, says Dr. McAneny.

“The data breach taught me a lot. Our practice spent a lot of money on increasing our internal controls, cybersecurity, and monitoring. Our IT department started testing our computer firewalls periodically, and that’s how we discovered that cybercriminals were attempting to break into our computer system at least 100 times daily,” says Dr. McAneny.

That discovery changed how she thought about insurance. “I decided the med-mal benefit wasn’t enough. I bought the best cybersecurity policy we could afford to protect against future breaches, especially malware or ransomware attacks.” 

Her practice also had to make its electronic health records (EHRs) more secure to comply with the Department of Health & Human Services Office of Civil Rights standards for protected health information. The cost of increased security wasn’t covered by her cyber benefit.
 

Cyberattacks increasing in health care

Despite having comprehensive coverage, Dr. McAneny worries that the cybercriminals are a step ahead of the cybersecurity experts and her practice will eventually have another data breach.

“The policy only covers things that we know about today. As we upgrade our defenses, criminals are finding new ways to breach firewalls and work around our defenses,” she says.

Cybercriminals – whether from foreign countries or just plain, homegrown thugs – have stepped up their attacks on health care organizations. So far this year, nearly 200 medical groups have reported cyberattacks involving 500 or more of their patients’ medical records to the federal government.

EHRs are valuable targets to cybercriminals because of the protected health information they contain. Cybercriminals grab information such as Social Security numbers, dates of birth, medical procedures and results, and in some cases billing and financial information and sell it on the dark web.

They typically bundle the information and sell it to other criminals who later use it for various kinds of fraud and extortion such as banking and credit fraud, health care fraud, identity theft, and ransom extortion.
 

What do most doctors have?

The vast majority (82%) of doctors polled by the Medical Group Management Association last year said they had cyber insurance, compared with 54% in 2018.

For those who answered “yes,” many said they have coverage through their malpractice insurance carrier.

David Zetter, president of Zetter HealthCare Management Consultants, recommends that physicians speak with their malpractice carrier to determine what coverage they have, if any, within their malpractice policy. 

A typical cybersecurity benefit is limited to what is needed to fix and resolve the hacking incident, says Raj Shah, senior regulatory attorney and policyholder advisor at MagMutual, which insures medical practices for malpractice and cyber liability.

That usually covers investigating the cause of the breach and the extent of the damage, legal advice about federal and state reporting requirements, whether to pay a ransom, and a public relations professional to handle patient communication, says Mr. Shah.

The benefit doesn’t cover lost patient revenue when practices have to shut down their operations, the cost of replacing damaged computers, or the ransom payment, he says.

Mr. Zetter advises doctors to consider buying cybersecurity coverage. “I recommend that they speak with an insurance broker who is experienced with cybersecurity policies sold to health care professionals to determine what type of coverage and how much coverage they may need. Their malpractice carrier may also be able to provide some answers,” says Mr. Zetter.

The physician will need to be able to answer questions about their network and how many staff they have and may need to involve their IT vendor too, he adds.
 

How does comprehensive coverage compare?

Ransomware attacks continue to be one of the most frequent types of attacks, and the amount criminals are demanding has risen significantly. The median ransom payment was $5,000 in the fourth quarter of 2018, compared with over $300,000 during the  fourth quarter of 2021.

Cybercriminals now engage in “double extortion” – demanding a ransom payment to hand over the code that will unlock their encrypted data – and then another ransom payment to not post patients’ sensitive medical information they copied onto the dark web.

Comprehensive cybersecurity insurance will cover “double extortion” payments, legal costs that may arise from defending against patient lawsuits, and the costs of meeting federal and state privacy requirements, including notifying patients of the data breach and regulatory investigations, says Michael Carr, head of risk engineering for North America for Coalition, a cyber insurance firm.  

Cyber insurers also contract with vendors who sell bitcoin, which is the currency cybercriminals typically demand for ransom payments, and work with ransom negotiators.

For example, once Coalition decided to pay the ransom on behalf of a health care client, it negotiated the ransom demand down by nearly 75% from $750,000 to $200,000, and proceeded to help the company restore all of its data.

The costs to respond to the incident, to recover lost data, and to pay the extortion, together with the lost business income resulting from the incident, were covered by Coalition’s cyber insurance policy.

Other clients have had their funds retrieved before a fraudulent wire transfer was completed. “Medical practices have vendors they pay regularly. A cybercriminal may compromise your email or take over a bank account and then impersonate a vendor asking to be paid for services they didn’t provide,” says Mr. Carr.
 

How much coverage do you need? Cost?

Dr. McAneny has increased her cybersecurity coverage every year. “It’s expensive, but I think it’s worth it. But you can never buy enough protection due to the coverage limits.”

She worries that the costs could exceed the limits if a ransomware attack disrupts her practice for days, weeks, or longer, or if the Office for Civil Rights fines her practice $10,000 per patient chart – the practice has 100,000 health records. “That can run several millions of dollars and ruin a practice,” she says.

Health systems and hospitals need massive amounts of coverage, which often runs from $20 million to $30 million, says Mr. Shah. However, practices insured through MagMutual have lower coverage limits that range from $1 million to $5 million, he says.

“A large practice does not necessarily need more than $1,000,000 in coverage if they have limited loss in this area and strong internal processes and controls. Most large practices also have a dedicated information security director, which reduces their risk, so they may be comfortable with $1,000,000 in coverage,” says Mr. Shah.

Premiums are based on the number of patient health records per practice, which translates into higher premiums for larger practices.

Other factors that come into play include the underlying coverage, risk controls the practice has implemented, and its claims history, says Mr. Shah.

However, the cost for cyber liability insurance has increased, and practices can expect to pay higher premiums and deductibles. For example, a practice that paid $10,000 in premiums for a new policy last year will have to pay $20,000 this year, says Dan Hanson, senior vice president of management liability and client experience at Marsh & McLennon Agency, a risk management firm that sells cyber insurance policies.

“We saw 71% of our self-insured clients experience higher deductibles over last year due to increased claim activity and the lack of capacity in the market. The carriers are saying they will set limits, but you are going to pay a lot more, and you are going to participate more in losses through the higher deductibles,” says Mr. Hanson.
 

Are you eligible?

Cyber insurance companies have a vested interest in avoiding claims. With increasing cyberattacks and larger payouts, many insurers are requiring practices to implement some defensive measures before they insure them. Some insurers, such as Coalition, say they may still insure small practices for comprehensive coverage, but it may impact the pricing or what’s covered, says Mr. Carr.  

Here are some of the security measures that cyber insurers are looking for:

• Multifactorial authentication (MFA) requires an extra layer of security to access the system. For example, when logging into your organization’s EHR platform, instead of just using a username and password to access the platform, MFA would require you to input an additional unique login credential before you can access the EHR. A secondary login credential may include security questions, a one-time PIN, or biometrics.
• Removing a terminated employee’s login credentials quickly from the computer system. “One of the most damaging and expensive types of attacks are by disgruntled employees who still have their login credentials and take revenge by logging back into the system and planting malware,” says Mr. Shah.
• Automatic system updates (patches). “Phishing email compromises usually result from a failure to fix vulnerabilities. When a system needs to restart, it should be set to automatically update any potential security loopholes within programs or products,” says Mr. Carr. The firewall settings should also be updated.
• Prior hacking incidents: Are the attackers out of your system? Once criminals hack into the system, your practice is vulnerable to repeat attacks. “If a cyberattack is not completely addressed, threat actors will maintain access to or a presence on the compromised network. In general, we will work with the insured to ensure that the initial point of compromise has been addressed and that any threat actor presence in the network has been removed,” says Mr. Carr.

When doctors compare cybersecurity policies, experts recommend avoiding companies that may offer lower prices but lack a proven track record of handling claims and do not offer resources that can detect a threat, such as ongoing network monitoring and employee training with simulated exercises.

“Practices tend to think, ‘It won’t happen to me.’ Every practice needs to take this seriously,” says Dr. McAneny.

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

Will your health plan pay for an abortion now that the Supreme Court has overturned Roe v. Wade?

Even before the June 24 ruling, insurance coverage for abortion varied widely. Now the issue is even more complex as states set varying rules – about half are expected to limit or ban abortion in almost all circumstances.

To be clear, though, the question of whether an insurance plan covers abortion is not the same as whether abortion is allowed in a state. Coverage issues are more complicated and governed by a wide variety of factors, including the level of abortion access a state allows.

How dense a thicket is it? Abortion may be covered by a health plan, but if no providers are available, patients don’t have access. However, people with insurance that does not cover abortion can still get one – but only if it’s available in their states or they can afford to travel and pay out of pocket. There are also a host of unanswered questions about whether states that restrict abortion will have the legal authority to target abortion coverage in employer plans.

The issues will likely be before the courts for years to come.

“States will pass laws, there will be some conflict, and then it goes to the courts,” said Erin Fuse Brown, director of the Center for Law, Health & Society at the Georgia State University, Atlanta. “It could be a while.”

In the meantime, here are answers to three common questions.
 

Are health plans – or employers – required to offer coverage for elective abortions?

The simple answer is “no.”

“There’s no law that requires any health plan, employer-based or anything else, to cover an elective abortion,” Ms. Fuse Brown said.

Whether they do is more complicated.

Some job-based health plans cover elective abortions. Patients can search their plan documents or call their insurers directly to check.

Coverage is more likely in plans offered by self-insured employers because a federal pensions law generally preempts state regulation of those health plans. Self-funded employers, which tend to be the larger ones, pay the medical bills, although they generally hire third parties, sometimes health insurers, to handle claims and administrative work.

Still, millions of Americans work for smaller employers, which tend to buy plans directly from health insurers, which then pay the medical bills. Those plans, known as “fully insured,” are subject to state laws, whose approaches to abortion coverage have long varied.

Eleven states bar those private plans from covering abortion in most circumstances, according to KFF, although some of the states allow consumers to purchase an insurance rider that would cover abortion costs.

If you’re not sure what type of health plan you have, ask the administrators.

“There is no way to tell from the face of your insurance card if you are fully insured or self-funded,” Ms. Fuse Brown said.

For the more than 14 million Americans who buy their coverage through the Affordable Care Act marketplaces, their state of residence is key.

Twenty-six states restrict abortion coverage in ACA plans, while seven states require it as a plan benefit, according to KFF. Those states are California, Illinois, Maine, Maryland, New York, Oregon, and Washington.

The rules for Medicaid, the federal-state health program for people with low incomes, also vary. Thirty-four states and the District of Columbia follow the so-called Hyde Amendment, which bars federal funds from paying for abortions, except in cases of rape or incest or to save the life of the mother, although some states allow coverage for other medically necessary abortions.

For all those reasons, it’s not surprising that research published in the journal Health Affairs noted that patients paid out-of-pocket for the majority of abortions (69% in one study). The researchers found that the median cost of a medication abortion was $560 and that abortion procedures ranged from a median of $575 in the first trimester to $895 in the second.
 

What about coverage for pregnancy-related complications that require treatment similar to abortion?

Insurance policies must cover care for essential health services, including medically necessary pregnancy care and abortion when carrying a pregnancy to term would endanger a patient’s life.

Under the Pregnancy Discrimination Act of 1978 and other rules, Ms. Fuse Brown said, “pregnancy and prenatal care, including high-risk pregnancies, and obstetric care in general is required to be covered.”

In an ectopic pregnancy – when a fertilized egg implants outside the uterus – the embryo is not viable, and the condition is generally life-threatening to the mother without medical treatment. Many other scenarios could come into play, including situations in which a woman has a miscarriage but not all the tissue is expelled, potentially leading to a dangerous infection.

Although all state laws that currently restrict abortion include an exception to save the life of the mother, what constitutes a life-threatening scenario is not always clear. That means physicians in abortion-ban states may have to weigh the pregnant person’s medical risk against possible legal ramifications.

“This is less of a coverage question and more of a question of whether providers in the states that ban abortion are going to provide the care,” said Katie Keith, a research faculty member at the Center on Health Insurance Reforms at Georgetown University, Washington. “All of these laws are designed to chill behavior, to make it so unattractive or scary to providers to keep them from doing it at all.”
 

Can residents of states where abortion is illegal get coverage in other states or help with travel costs?

In recent weeks, many large employers – including Microsoft, Bank of America, Disney, and Netflix – have said they will set up programs to help pay travel costs so workers or other beneficiaries in states with bans can travel to get an abortion elsewhere.

But it isn’t as straightforward as it sounds. Employers will have to figure out whether workers will access this benefit through the health plan or some other reimbursement method. Protecting privacy, too, may be an issue. Some consultants also said employers will need to consider whether their travel reimbursement benefit conflicts with other rules. If an employer, for example, covers travel for abortion procedures but not for an eating disorder clinic, does that violate the Mental Health Parity and Addiction Equity Act? If a plan has no providers willing or able to do abortions, does it violate any state or federal network adequacy rules?

Lawmakers need to think about these conflicts, said Jessica Waltman, vice president for compliance at employee benefits company MZQ Consulting. “They could be putting all the employer group plans in their state in a very precarious position if that state law would prohibit them from complying with federal law,” particularly if they restrict access to benefits called for in the Pregnancy Discrimination Act.

There are other potential conflicts if an employer is in a state that allows abortion but a worker is in a state that restricts it. “If I’m an Oregon-based company, my insurance plan must provide for abortion coverage, but what do I do about an Oklahoma employee? I don’t know the answer,” said René Thorne, a principal at Jackson Lewis, where she oversees litigation that involves self-insured firms.

Also uncertain is whether state laws will take aim at insurers, employers, or others that offer benefits, including travel or televisits, for abortion services.

Laws that restrict abortion, Ms. Thorne wrote in a white paper for clients, generally apply to the medical provider and sometimes those who “aid or abet” the abortion. Some states, including Texas, allow private citizens to sue for $10,000 anyone who provides an illegal abortion or helps a person access an abortion.

Whether those laws will be applied to employers or insurers will undoubtedly end up in the courts.

“We are in uncharted territory here, as we’ve never before been in a situation where plans, as well as their employer sponsors and those administering the plans, might face criminal liability in connection with a plan benefit,” said Seth Perretta, a principal at the Groom Law Group, which advises employers.

Answers won’t come soon, but “there will be so much litigation around this,” said Ms. Thorne.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Will your health plan pay for an abortion now that the Supreme Court has overturned Roe v. Wade?

Even before the June 24 ruling, insurance coverage for abortion varied widely. Now the issue is even more complex as states set varying rules – about half are expected to limit or ban abortion in almost all circumstances.

To be clear, though, the question of whether an insurance plan covers abortion is not the same as whether abortion is allowed in a state. Coverage issues are more complicated and governed by a wide variety of factors, including the level of abortion access a state allows.

How dense a thicket is it? Abortion may be covered by a health plan, but if no providers are available, patients don’t have access. However, people with insurance that does not cover abortion can still get one – but only if it’s available in their states or they can afford to travel and pay out of pocket. There are also a host of unanswered questions about whether states that restrict abortion will have the legal authority to target abortion coverage in employer plans.

The issues will likely be before the courts for years to come.

“States will pass laws, there will be some conflict, and then it goes to the courts,” said Erin Fuse Brown, director of the Center for Law, Health & Society at the Georgia State University, Atlanta. “It could be a while.”

In the meantime, here are answers to three common questions.
 

Are health plans – or employers – required to offer coverage for elective abortions?

The simple answer is “no.”

“There’s no law that requires any health plan, employer-based or anything else, to cover an elective abortion,” Ms. Fuse Brown said.

Whether they do is more complicated.

Some job-based health plans cover elective abortions. Patients can search their plan documents or call their insurers directly to check.

Coverage is more likely in plans offered by self-insured employers because a federal pensions law generally preempts state regulation of those health plans. Self-funded employers, which tend to be the larger ones, pay the medical bills, although they generally hire third parties, sometimes health insurers, to handle claims and administrative work.

Still, millions of Americans work for smaller employers, which tend to buy plans directly from health insurers, which then pay the medical bills. Those plans, known as “fully insured,” are subject to state laws, whose approaches to abortion coverage have long varied.

Eleven states bar those private plans from covering abortion in most circumstances, according to KFF, although some of the states allow consumers to purchase an insurance rider that would cover abortion costs.

If you’re not sure what type of health plan you have, ask the administrators.

“There is no way to tell from the face of your insurance card if you are fully insured or self-funded,” Ms. Fuse Brown said.

For the more than 14 million Americans who buy their coverage through the Affordable Care Act marketplaces, their state of residence is key.

Twenty-six states restrict abortion coverage in ACA plans, while seven states require it as a plan benefit, according to KFF. Those states are California, Illinois, Maine, Maryland, New York, Oregon, and Washington.

The rules for Medicaid, the federal-state health program for people with low incomes, also vary. Thirty-four states and the District of Columbia follow the so-called Hyde Amendment, which bars federal funds from paying for abortions, except in cases of rape or incest or to save the life of the mother, although some states allow coverage for other medically necessary abortions.

For all those reasons, it’s not surprising that research published in the journal Health Affairs noted that patients paid out-of-pocket for the majority of abortions (69% in one study). The researchers found that the median cost of a medication abortion was $560 and that abortion procedures ranged from a median of $575 in the first trimester to $895 in the second.
 

What about coverage for pregnancy-related complications that require treatment similar to abortion?

Insurance policies must cover care for essential health services, including medically necessary pregnancy care and abortion when carrying a pregnancy to term would endanger a patient’s life.

Under the Pregnancy Discrimination Act of 1978 and other rules, Ms. Fuse Brown said, “pregnancy and prenatal care, including high-risk pregnancies, and obstetric care in general is required to be covered.”

In an ectopic pregnancy – when a fertilized egg implants outside the uterus – the embryo is not viable, and the condition is generally life-threatening to the mother without medical treatment. Many other scenarios could come into play, including situations in which a woman has a miscarriage but not all the tissue is expelled, potentially leading to a dangerous infection.

Although all state laws that currently restrict abortion include an exception to save the life of the mother, what constitutes a life-threatening scenario is not always clear. That means physicians in abortion-ban states may have to weigh the pregnant person’s medical risk against possible legal ramifications.

“This is less of a coverage question and more of a question of whether providers in the states that ban abortion are going to provide the care,” said Katie Keith, a research faculty member at the Center on Health Insurance Reforms at Georgetown University, Washington. “All of these laws are designed to chill behavior, to make it so unattractive or scary to providers to keep them from doing it at all.”
 

Can residents of states where abortion is illegal get coverage in other states or help with travel costs?

In recent weeks, many large employers – including Microsoft, Bank of America, Disney, and Netflix – have said they will set up programs to help pay travel costs so workers or other beneficiaries in states with bans can travel to get an abortion elsewhere.

But it isn’t as straightforward as it sounds. Employers will have to figure out whether workers will access this benefit through the health plan or some other reimbursement method. Protecting privacy, too, may be an issue. Some consultants also said employers will need to consider whether their travel reimbursement benefit conflicts with other rules. If an employer, for example, covers travel for abortion procedures but not for an eating disorder clinic, does that violate the Mental Health Parity and Addiction Equity Act? If a plan has no providers willing or able to do abortions, does it violate any state or federal network adequacy rules?

Lawmakers need to think about these conflicts, said Jessica Waltman, vice president for compliance at employee benefits company MZQ Consulting. “They could be putting all the employer group plans in their state in a very precarious position if that state law would prohibit them from complying with federal law,” particularly if they restrict access to benefits called for in the Pregnancy Discrimination Act.

There are other potential conflicts if an employer is in a state that allows abortion but a worker is in a state that restricts it. “If I’m an Oregon-based company, my insurance plan must provide for abortion coverage, but what do I do about an Oklahoma employee? I don’t know the answer,” said René Thorne, a principal at Jackson Lewis, where she oversees litigation that involves self-insured firms.

Also uncertain is whether state laws will take aim at insurers, employers, or others that offer benefits, including travel or televisits, for abortion services.

Laws that restrict abortion, Ms. Thorne wrote in a white paper for clients, generally apply to the medical provider and sometimes those who “aid or abet” the abortion. Some states, including Texas, allow private citizens to sue for $10,000 anyone who provides an illegal abortion or helps a person access an abortion.

Whether those laws will be applied to employers or insurers will undoubtedly end up in the courts.

“We are in uncharted territory here, as we’ve never before been in a situation where plans, as well as their employer sponsors and those administering the plans, might face criminal liability in connection with a plan benefit,” said Seth Perretta, a principal at the Groom Law Group, which advises employers.

Answers won’t come soon, but “there will be so much litigation around this,” said Ms. Thorne.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Will your health plan pay for an abortion now that the Supreme Court has overturned Roe v. Wade?

Even before the June 24 ruling, insurance coverage for abortion varied widely. Now the issue is even more complex as states set varying rules – about half are expected to limit or ban abortion in almost all circumstances.

To be clear, though, the question of whether an insurance plan covers abortion is not the same as whether abortion is allowed in a state. Coverage issues are more complicated and governed by a wide variety of factors, including the level of abortion access a state allows.

How dense a thicket is it? Abortion may be covered by a health plan, but if no providers are available, patients don’t have access. However, people with insurance that does not cover abortion can still get one – but only if it’s available in their states or they can afford to travel and pay out of pocket. There are also a host of unanswered questions about whether states that restrict abortion will have the legal authority to target abortion coverage in employer plans.

The issues will likely be before the courts for years to come.

“States will pass laws, there will be some conflict, and then it goes to the courts,” said Erin Fuse Brown, director of the Center for Law, Health & Society at the Georgia State University, Atlanta. “It could be a while.”

In the meantime, here are answers to three common questions.
 

Are health plans – or employers – required to offer coverage for elective abortions?

The simple answer is “no.”

“There’s no law that requires any health plan, employer-based or anything else, to cover an elective abortion,” Ms. Fuse Brown said.

Whether they do is more complicated.

Some job-based health plans cover elective abortions. Patients can search their plan documents or call their insurers directly to check.

Coverage is more likely in plans offered by self-insured employers because a federal pensions law generally preempts state regulation of those health plans. Self-funded employers, which tend to be the larger ones, pay the medical bills, although they generally hire third parties, sometimes health insurers, to handle claims and administrative work.

Still, millions of Americans work for smaller employers, which tend to buy plans directly from health insurers, which then pay the medical bills. Those plans, known as “fully insured,” are subject to state laws, whose approaches to abortion coverage have long varied.

Eleven states bar those private plans from covering abortion in most circumstances, according to KFF, although some of the states allow consumers to purchase an insurance rider that would cover abortion costs.

If you’re not sure what type of health plan you have, ask the administrators.

“There is no way to tell from the face of your insurance card if you are fully insured or self-funded,” Ms. Fuse Brown said.

For the more than 14 million Americans who buy their coverage through the Affordable Care Act marketplaces, their state of residence is key.

Twenty-six states restrict abortion coverage in ACA plans, while seven states require it as a plan benefit, according to KFF. Those states are California, Illinois, Maine, Maryland, New York, Oregon, and Washington.

The rules for Medicaid, the federal-state health program for people with low incomes, also vary. Thirty-four states and the District of Columbia follow the so-called Hyde Amendment, which bars federal funds from paying for abortions, except in cases of rape or incest or to save the life of the mother, although some states allow coverage for other medically necessary abortions.

For all those reasons, it’s not surprising that research published in the journal Health Affairs noted that patients paid out-of-pocket for the majority of abortions (69% in one study). The researchers found that the median cost of a medication abortion was $560 and that abortion procedures ranged from a median of $575 in the first trimester to $895 in the second.
 

What about coverage for pregnancy-related complications that require treatment similar to abortion?

Insurance policies must cover care for essential health services, including medically necessary pregnancy care and abortion when carrying a pregnancy to term would endanger a patient’s life.

Under the Pregnancy Discrimination Act of 1978 and other rules, Ms. Fuse Brown said, “pregnancy and prenatal care, including high-risk pregnancies, and obstetric care in general is required to be covered.”

In an ectopic pregnancy – when a fertilized egg implants outside the uterus – the embryo is not viable, and the condition is generally life-threatening to the mother without medical treatment. Many other scenarios could come into play, including situations in which a woman has a miscarriage but not all the tissue is expelled, potentially leading to a dangerous infection.

Although all state laws that currently restrict abortion include an exception to save the life of the mother, what constitutes a life-threatening scenario is not always clear. That means physicians in abortion-ban states may have to weigh the pregnant person’s medical risk against possible legal ramifications.

“This is less of a coverage question and more of a question of whether providers in the states that ban abortion are going to provide the care,” said Katie Keith, a research faculty member at the Center on Health Insurance Reforms at Georgetown University, Washington. “All of these laws are designed to chill behavior, to make it so unattractive or scary to providers to keep them from doing it at all.”
 

Can residents of states where abortion is illegal get coverage in other states or help with travel costs?

In recent weeks, many large employers – including Microsoft, Bank of America, Disney, and Netflix – have said they will set up programs to help pay travel costs so workers or other beneficiaries in states with bans can travel to get an abortion elsewhere.

But it isn’t as straightforward as it sounds. Employers will have to figure out whether workers will access this benefit through the health plan or some other reimbursement method. Protecting privacy, too, may be an issue. Some consultants also said employers will need to consider whether their travel reimbursement benefit conflicts with other rules. If an employer, for example, covers travel for abortion procedures but not for an eating disorder clinic, does that violate the Mental Health Parity and Addiction Equity Act? If a plan has no providers willing or able to do abortions, does it violate any state or federal network adequacy rules?

Lawmakers need to think about these conflicts, said Jessica Waltman, vice president for compliance at employee benefits company MZQ Consulting. “They could be putting all the employer group plans in their state in a very precarious position if that state law would prohibit them from complying with federal law,” particularly if they restrict access to benefits called for in the Pregnancy Discrimination Act.

There are other potential conflicts if an employer is in a state that allows abortion but a worker is in a state that restricts it. “If I’m an Oregon-based company, my insurance plan must provide for abortion coverage, but what do I do about an Oklahoma employee? I don’t know the answer,” said René Thorne, a principal at Jackson Lewis, where she oversees litigation that involves self-insured firms.

Also uncertain is whether state laws will take aim at insurers, employers, or others that offer benefits, including travel or televisits, for abortion services.

Laws that restrict abortion, Ms. Thorne wrote in a white paper for clients, generally apply to the medical provider and sometimes those who “aid or abet” the abortion. Some states, including Texas, allow private citizens to sue for $10,000 anyone who provides an illegal abortion or helps a person access an abortion.

Whether those laws will be applied to employers or insurers will undoubtedly end up in the courts.

“We are in uncharted territory here, as we’ve never before been in a situation where plans, as well as their employer sponsors and those administering the plans, might face criminal liability in connection with a plan benefit,” said Seth Perretta, a principal at the Groom Law Group, which advises employers.

Answers won’t come soon, but “there will be so much litigation around this,” said Ms. Thorne.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

The Justice Department is launching a Reproductive Rights Task Force to prevent state and local governments from overreach if they impose new abortion bans.

Department officials announced July 12 that the task force formalizes an existing work group and recent efforts to protect access to reproductive health care considering the Supreme Court’s decision to overturn Roe v. Wade.

The task force will monitor state and local legislation and consider legal action against states that ban abortion medication, out-of-state travel for an abortion, and other measures that try to prevent reproductive health services that are authorized by federal law.

“The Supreme Court’s Dobbs decision is a devastating blow to reproductive freedom in the United States,” Associate Attorney General Vanita Gupta, the task force chair, said in a statement.

“The Court abandoned 50 years of precedent and took away the constitutional right to abortion, preventing women all over the country from being able to make critical decisions about our bodies, our health, and our futures,” she said. “The Justice Department is committed to protecting access to reproductive services.”

The task force includes representatives from the Justice Department’s Civil Division, Civil Rights Division, U.S. attorneys’ offices, Office of the Solicitor General, Office for Access to Justice, Office of Legal Counsel, Office of Legal Policy, Office of Legislative Affairs, Office of the Associate Attorney General, Office of the Deputy Attorney General, and Office of the Attorney General.

The task force is charged with coordinating federal government responses, including proactive and defensive legal action, the department said. Task force members will work with agencies across the federal government to support their work on issues related to reproductive rights and access to reproductive health care.

The Justice Department will also continue to work with external groups, such as reproductive services providers, advocates, and state attorneys general offices. It will also work with the Office of Counsel to the President to hold a meeting with private pro bono attorneys, bar associations, and public interest groups to encourage lawyers to represent patients, providers, and others in reproductive health services cases.

“Recognizing that the best way to protect reproductive freedom is through congressional action, the task force will also coordinate providing technical assistance to Congress in connection with federal legislation to codify reproductive rights and ensure access to comprehensive reproductive services,” the department wrote. “It will also coordinate the provision of technical assistance concerning federal constitutional protections to states seeking to afford legal protection to out-of-state patients and providers who offer legal reproductive health care.”

The announcement comes as some activists and lawmakers have expressed frustration about the White House’s response to changes in abortion law in recent weeks, according to The Washington Post. They’ve called on the Biden administration to do more in the wake of the Supreme Court ruling.

On July 8, President Joe Biden signed an executive order to direct his administration to pursue a variety of measures aimed at protecting abortion access, reproductive health care services, and patient privacy.

On July 11, the Department of Health & Human Services issued guidance to remind hospitals of their duty to comply with the Emergency Medical Treatment and Labor Act (EMTALA), which stands “irrespective of any state laws or mandates that apply to specific procedures.” The law requires health care personnel to provide medical screening and stabilizing treatment to patients in emergency medical situations. In the case of pregnancy, emergencies may include ectopic pregnancy, complications of pregnancy loss, or severe hypertensive disorders. Doctors must terminate a pregnancy if it’s necessary to stabilize the patient.

“When a state law prohibits abortion and does not include an exception for the life and health of the pregnant person – or draws the exception more narrowly than EMTALA’s emergency medical condition definition – that state law is preempted,” the department wrote.

Since the Supreme Court’s ruling to overturn Roe, more than a dozen states have moved to ban or severely restrict abortions, according to a state tracker by The Washington Post. Some of the laws have been temporarily blocked by courts in Kentucky, Louisiana, and Utah.

At the same time, some Republican-led states have moved to ban other reproductive health care services, such as abortion medication and telehealth visits, the newspaper reported. The Food and Drug Administration approved mifepristone in 2000, saying the pill is safe and effective for use during the first 10 weeks of pregnancy.

The Justice Department task force said it will monitor legislation that seeks to ban mifepristone, as well as block people’s ability to inform each other about reproductive care available across the country.

“We’re seeing the intimidation already in states that are making people afraid to share information about legal abortion services in other states,” Nancy Northup, president and chief executive of the Center for Reproductive Rights, told the newspaper.

The center served as the legal counsel for the Jackson Women’s Health Organization in the case that overturned Roe. Ms. Northup said the group is already involved in more than three dozen lawsuits and has filed several more since the Supreme Court’s ruling.

“It is a really frightening time,” she said.

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

The Justice Department is launching a Reproductive Rights Task Force to prevent state and local governments from overreach if they impose new abortion bans.

Department officials announced July 12 that the task force formalizes an existing work group and recent efforts to protect access to reproductive health care considering the Supreme Court’s decision to overturn Roe v. Wade.

The task force will monitor state and local legislation and consider legal action against states that ban abortion medication, out-of-state travel for an abortion, and other measures that try to prevent reproductive health services that are authorized by federal law.

“The Supreme Court’s Dobbs decision is a devastating blow to reproductive freedom in the United States,” Associate Attorney General Vanita Gupta, the task force chair, said in a statement.

“The Court abandoned 50 years of precedent and took away the constitutional right to abortion, preventing women all over the country from being able to make critical decisions about our bodies, our health, and our futures,” she said. “The Justice Department is committed to protecting access to reproductive services.”

The task force includes representatives from the Justice Department’s Civil Division, Civil Rights Division, U.S. attorneys’ offices, Office of the Solicitor General, Office for Access to Justice, Office of Legal Counsel, Office of Legal Policy, Office of Legislative Affairs, Office of the Associate Attorney General, Office of the Deputy Attorney General, and Office of the Attorney General.

The task force is charged with coordinating federal government responses, including proactive and defensive legal action, the department said. Task force members will work with agencies across the federal government to support their work on issues related to reproductive rights and access to reproductive health care.

The Justice Department will also continue to work with external groups, such as reproductive services providers, advocates, and state attorneys general offices. It will also work with the Office of Counsel to the President to hold a meeting with private pro bono attorneys, bar associations, and public interest groups to encourage lawyers to represent patients, providers, and others in reproductive health services cases.

“Recognizing that the best way to protect reproductive freedom is through congressional action, the task force will also coordinate providing technical assistance to Congress in connection with federal legislation to codify reproductive rights and ensure access to comprehensive reproductive services,” the department wrote. “It will also coordinate the provision of technical assistance concerning federal constitutional protections to states seeking to afford legal protection to out-of-state patients and providers who offer legal reproductive health care.”

The announcement comes as some activists and lawmakers have expressed frustration about the White House’s response to changes in abortion law in recent weeks, according to The Washington Post. They’ve called on the Biden administration to do more in the wake of the Supreme Court ruling.

On July 8, President Joe Biden signed an executive order to direct his administration to pursue a variety of measures aimed at protecting abortion access, reproductive health care services, and patient privacy.

On July 11, the Department of Health & Human Services issued guidance to remind hospitals of their duty to comply with the Emergency Medical Treatment and Labor Act (EMTALA), which stands “irrespective of any state laws or mandates that apply to specific procedures.” The law requires health care personnel to provide medical screening and stabilizing treatment to patients in emergency medical situations. In the case of pregnancy, emergencies may include ectopic pregnancy, complications of pregnancy loss, or severe hypertensive disorders. Doctors must terminate a pregnancy if it’s necessary to stabilize the patient.

“When a state law prohibits abortion and does not include an exception for the life and health of the pregnant person – or draws the exception more narrowly than EMTALA’s emergency medical condition definition – that state law is preempted,” the department wrote.

Since the Supreme Court’s ruling to overturn Roe, more than a dozen states have moved to ban or severely restrict abortions, according to a state tracker by The Washington Post. Some of the laws have been temporarily blocked by courts in Kentucky, Louisiana, and Utah.

At the same time, some Republican-led states have moved to ban other reproductive health care services, such as abortion medication and telehealth visits, the newspaper reported. The Food and Drug Administration approved mifepristone in 2000, saying the pill is safe and effective for use during the first 10 weeks of pregnancy.

The Justice Department task force said it will monitor legislation that seeks to ban mifepristone, as well as block people’s ability to inform each other about reproductive care available across the country.

“We’re seeing the intimidation already in states that are making people afraid to share information about legal abortion services in other states,” Nancy Northup, president and chief executive of the Center for Reproductive Rights, told the newspaper.

The center served as the legal counsel for the Jackson Women’s Health Organization in the case that overturned Roe. Ms. Northup said the group is already involved in more than three dozen lawsuits and has filed several more since the Supreme Court’s ruling.

“It is a really frightening time,” she said.

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

The Justice Department is launching a Reproductive Rights Task Force to prevent state and local governments from overreach if they impose new abortion bans.

Department officials announced July 12 that the task force formalizes an existing work group and recent efforts to protect access to reproductive health care considering the Supreme Court’s decision to overturn Roe v. Wade.

The task force will monitor state and local legislation and consider legal action against states that ban abortion medication, out-of-state travel for an abortion, and other measures that try to prevent reproductive health services that are authorized by federal law.

“The Supreme Court’s Dobbs decision is a devastating blow to reproductive freedom in the United States,” Associate Attorney General Vanita Gupta, the task force chair, said in a statement.

“The Court abandoned 50 years of precedent and took away the constitutional right to abortion, preventing women all over the country from being able to make critical decisions about our bodies, our health, and our futures,” she said. “The Justice Department is committed to protecting access to reproductive services.”

The task force includes representatives from the Justice Department’s Civil Division, Civil Rights Division, U.S. attorneys’ offices, Office of the Solicitor General, Office for Access to Justice, Office of Legal Counsel, Office of Legal Policy, Office of Legislative Affairs, Office of the Associate Attorney General, Office of the Deputy Attorney General, and Office of the Attorney General.

The task force is charged with coordinating federal government responses, including proactive and defensive legal action, the department said. Task force members will work with agencies across the federal government to support their work on issues related to reproductive rights and access to reproductive health care.

The Justice Department will also continue to work with external groups, such as reproductive services providers, advocates, and state attorneys general offices. It will also work with the Office of Counsel to the President to hold a meeting with private pro bono attorneys, bar associations, and public interest groups to encourage lawyers to represent patients, providers, and others in reproductive health services cases.

“Recognizing that the best way to protect reproductive freedom is through congressional action, the task force will also coordinate providing technical assistance to Congress in connection with federal legislation to codify reproductive rights and ensure access to comprehensive reproductive services,” the department wrote. “It will also coordinate the provision of technical assistance concerning federal constitutional protections to states seeking to afford legal protection to out-of-state patients and providers who offer legal reproductive health care.”

The announcement comes as some activists and lawmakers have expressed frustration about the White House’s response to changes in abortion law in recent weeks, according to The Washington Post. They’ve called on the Biden administration to do more in the wake of the Supreme Court ruling.

On July 8, President Joe Biden signed an executive order to direct his administration to pursue a variety of measures aimed at protecting abortion access, reproductive health care services, and patient privacy.

On July 11, the Department of Health & Human Services issued guidance to remind hospitals of their duty to comply with the Emergency Medical Treatment and Labor Act (EMTALA), which stands “irrespective of any state laws or mandates that apply to specific procedures.” The law requires health care personnel to provide medical screening and stabilizing treatment to patients in emergency medical situations. In the case of pregnancy, emergencies may include ectopic pregnancy, complications of pregnancy loss, or severe hypertensive disorders. Doctors must terminate a pregnancy if it’s necessary to stabilize the patient.

“When a state law prohibits abortion and does not include an exception for the life and health of the pregnant person – or draws the exception more narrowly than EMTALA’s emergency medical condition definition – that state law is preempted,” the department wrote.

Since the Supreme Court’s ruling to overturn Roe, more than a dozen states have moved to ban or severely restrict abortions, according to a state tracker by The Washington Post. Some of the laws have been temporarily blocked by courts in Kentucky, Louisiana, and Utah.

At the same time, some Republican-led states have moved to ban other reproductive health care services, such as abortion medication and telehealth visits, the newspaper reported. The Food and Drug Administration approved mifepristone in 2000, saying the pill is safe and effective for use during the first 10 weeks of pregnancy.

The Justice Department task force said it will monitor legislation that seeks to ban mifepristone, as well as block people’s ability to inform each other about reproductive care available across the country.

“We’re seeing the intimidation already in states that are making people afraid to share information about legal abortion services in other states,” Nancy Northup, president and chief executive of the Center for Reproductive Rights, told the newspaper.

The center served as the legal counsel for the Jackson Women’s Health Organization in the case that overturned Roe. Ms. Northup said the group is already involved in more than three dozen lawsuits and has filed several more since the Supreme Court’s ruling.

“It is a really frightening time,” she said.

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

INDIANAPOLIS – Three factors that may encourage trainees to pursue a career in pediatric dermatology include early exposure to the subspecialty during medical school, mentorship by a board-certified pediatric dermatologist at the trainee’s home institution, and increased salary benefits during and after fellowship.

Those are key findings from a survey of current and prior pediatric dermatology fellows, which sought to investigate what factors influence their career decisions.

According to the study’s principal investigator, Lucia Z. Diaz, MD, pediatric dermatology suffers from workforce shortages and geographic maldistribution as a subspecialty in the United States. She also noted that, from 2016 to 2021, 100% of pediatric dermatology applicants matched, yet about 15 of every 31 positions remained unfilled during each of those years. This suggests that there may be a lack of trainee mentorship secondary to a lack of available pediatric dermatologists.

“Somewhere along the way, we lose trainees to general dermatology, or they may go through a pediatric dermatology fellowship but not actually see children upon completion of their training,” Dr. Diaz, chief of pediatric dermatology at the University of Texas at Austin, said in an interview at the annual meeting of the Society for Pediatric Dermatology, where the study was presented during a poster session. “We wanted to find out factors influencing this.”

For the study, Dr. Diaz, Courtney N. Haller, MD, a first-year dermatology resident at the University of Texas at Austin, and their colleagues emailed a 37-item survey to 59 current and prior pediatric dermatology fellows who trained in the United States in the past 4 years (classes of 2019-2022). Current fellows were asked to share their future plans, and past fellows were asked to share details about their current practice situation including practice type (such as academics, private practice, and a mix of adult and pediatrics), and the researchers used descriptive statistics and chi-square analyses to evaluate qualitative data.

Doug Brunk/MDedge News

In all, 41 survey participants gave complete responses, and 3 gave partial responses. Of these, 8 were current fellows, 36 were past fellows, and 38 were female. The researchers found that 67% of survey respondents first became interested in pediatric dermatology in medical school, while the decision to pursue a fellowship occurred then (33%) or during their third year of dermatology residency (33%). Early exposure to pediatric dermatology, from medical school through dermatology PGY-2, was significantly associated with an early decision to pursue a pediatric dermatology career (P = .004).

In addition, respondents at institutions with two or more pediatric dermatology faculty were significantly more likely to cite home institution mentorship as an influencing factor in their career decision (P = .035).

“I thought that the interest in pediatric dermatology would peak early on during dermatology residency, but it primarily happens during medical school,” said Dr. Diaz, who is also associate director of the dermatology residency program at the medical school. “Mentorship and early exposure to pediatric dermatology during medical school are really important.”

The top three factors that discouraged respondents from pursuing a pediatric dermatology fellowship included a lack of salary benefit with additional training (83%), additional time required to complete training (73%), and geographic relocation (20%). After fellowship, 51% of respondents said they plan to or currently work in academic settings, while 88% said they plan to work full time or currently were working full time.

Interestingly, fellows with additional pediatric training such as an internship or residency were not more likely to see a greater percentage of pediatric patients in practice than those without this training (P = .14). The top 3 reasons for not seeing pediatric patients 100% of the clinical time were interest in seeing adult patients (67%), financial factors (56%), and interest in performing more procedures (56%).

In other findings, the top three factors in deciding practice location were proximity to extended family (63%), practice type (59%), and income (51%).

INDIANAPOLIS – Three factors that may encourage trainees to pursue a career in pediatric dermatology include early exposure to the subspecialty during medical school, mentorship by a board-certified pediatric dermatologist at the trainee’s home institution, and increased salary benefits during and after fellowship.

Those are key findings from a survey of current and prior pediatric dermatology fellows, which sought to investigate what factors influence their career decisions.

According to the study’s principal investigator, Lucia Z. Diaz, MD, pediatric dermatology suffers from workforce shortages and geographic maldistribution as a subspecialty in the United States. She also noted that, from 2016 to 2021, 100% of pediatric dermatology applicants matched, yet about 15 of every 31 positions remained unfilled during each of those years. This suggests that there may be a lack of trainee mentorship secondary to a lack of available pediatric dermatologists.

“Somewhere along the way, we lose trainees to general dermatology, or they may go through a pediatric dermatology fellowship but not actually see children upon completion of their training,” Dr. Diaz, chief of pediatric dermatology at the University of Texas at Austin, said in an interview at the annual meeting of the Society for Pediatric Dermatology, where the study was presented during a poster session. “We wanted to find out factors influencing this.”

For the study, Dr. Diaz, Courtney N. Haller, MD, a first-year dermatology resident at the University of Texas at Austin, and their colleagues emailed a 37-item survey to 59 current and prior pediatric dermatology fellows who trained in the United States in the past 4 years (classes of 2019-2022). Current fellows were asked to share their future plans, and past fellows were asked to share details about their current practice situation including practice type (such as academics, private practice, and a mix of adult and pediatrics), and the researchers used descriptive statistics and chi-square analyses to evaluate qualitative data.

Doug Brunk/MDedge News

In all, 41 survey participants gave complete responses, and 3 gave partial responses. Of these, 8 were current fellows, 36 were past fellows, and 38 were female. The researchers found that 67% of survey respondents first became interested in pediatric dermatology in medical school, while the decision to pursue a fellowship occurred then (33%) or during their third year of dermatology residency (33%). Early exposure to pediatric dermatology, from medical school through dermatology PGY-2, was significantly associated with an early decision to pursue a pediatric dermatology career (P = .004).

In addition, respondents at institutions with two or more pediatric dermatology faculty were significantly more likely to cite home institution mentorship as an influencing factor in their career decision (P = .035).

“I thought that the interest in pediatric dermatology would peak early on during dermatology residency, but it primarily happens during medical school,” said Dr. Diaz, who is also associate director of the dermatology residency program at the medical school. “Mentorship and early exposure to pediatric dermatology during medical school are really important.”

The top three factors that discouraged respondents from pursuing a pediatric dermatology fellowship included a lack of salary benefit with additional training (83%), additional time required to complete training (73%), and geographic relocation (20%). After fellowship, 51% of respondents said they plan to or currently work in academic settings, while 88% said they plan to work full time or currently were working full time.

Interestingly, fellows with additional pediatric training such as an internship or residency were not more likely to see a greater percentage of pediatric patients in practice than those without this training (P = .14). The top 3 reasons for not seeing pediatric patients 100% of the clinical time were interest in seeing adult patients (67%), financial factors (56%), and interest in performing more procedures (56%).

In other findings, the top three factors in deciding practice location were proximity to extended family (63%), practice type (59%), and income (51%).

INDIANAPOLIS – Three factors that may encourage trainees to pursue a career in pediatric dermatology include early exposure to the subspecialty during medical school, mentorship by a board-certified pediatric dermatologist at the trainee’s home institution, and increased salary benefits during and after fellowship.

Those are key findings from a survey of current and prior pediatric dermatology fellows, which sought to investigate what factors influence their career decisions.

According to the study’s principal investigator, Lucia Z. Diaz, MD, pediatric dermatology suffers from workforce shortages and geographic maldistribution as a subspecialty in the United States. She also noted that, from 2016 to 2021, 100% of pediatric dermatology applicants matched, yet about 15 of every 31 positions remained unfilled during each of those years. This suggests that there may be a lack of trainee mentorship secondary to a lack of available pediatric dermatologists.

“Somewhere along the way, we lose trainees to general dermatology, or they may go through a pediatric dermatology fellowship but not actually see children upon completion of their training,” Dr. Diaz, chief of pediatric dermatology at the University of Texas at Austin, said in an interview at the annual meeting of the Society for Pediatric Dermatology, where the study was presented during a poster session. “We wanted to find out factors influencing this.”

For the study, Dr. Diaz, Courtney N. Haller, MD, a first-year dermatology resident at the University of Texas at Austin, and their colleagues emailed a 37-item survey to 59 current and prior pediatric dermatology fellows who trained in the United States in the past 4 years (classes of 2019-2022). Current fellows were asked to share their future plans, and past fellows were asked to share details about their current practice situation including practice type (such as academics, private practice, and a mix of adult and pediatrics), and the researchers used descriptive statistics and chi-square analyses to evaluate qualitative data.

Doug Brunk/MDedge News

In all, 41 survey participants gave complete responses, and 3 gave partial responses. Of these, 8 were current fellows, 36 were past fellows, and 38 were female. The researchers found that 67% of survey respondents first became interested in pediatric dermatology in medical school, while the decision to pursue a fellowship occurred then (33%) or during their third year of dermatology residency (33%). Early exposure to pediatric dermatology, from medical school through dermatology PGY-2, was significantly associated with an early decision to pursue a pediatric dermatology career (P = .004).

In addition, respondents at institutions with two or more pediatric dermatology faculty were significantly more likely to cite home institution mentorship as an influencing factor in their career decision (P = .035).

“I thought that the interest in pediatric dermatology would peak early on during dermatology residency, but it primarily happens during medical school,” said Dr. Diaz, who is also associate director of the dermatology residency program at the medical school. “Mentorship and early exposure to pediatric dermatology during medical school are really important.”

The top three factors that discouraged respondents from pursuing a pediatric dermatology fellowship included a lack of salary benefit with additional training (83%), additional time required to complete training (73%), and geographic relocation (20%). After fellowship, 51% of respondents said they plan to or currently work in academic settings, while 88% said they plan to work full time or currently were working full time.

Interestingly, fellows with additional pediatric training such as an internship or residency were not more likely to see a greater percentage of pediatric patients in practice than those without this training (P = .14). The top 3 reasons for not seeing pediatric patients 100% of the clinical time were interest in seeing adult patients (67%), financial factors (56%), and interest in performing more procedures (56%).

In other findings, the top three factors in deciding practice location were proximity to extended family (63%), practice type (59%), and income (51%).

In oncology, delayed care may result in a failed opportunity to achieve remission. Delays in diagnosis can result in patients having to undergo more extensive surgery, radiation exposure, or more intensive drug therapy than if their disease had been detected at an early stage.

Now, researchers at Harvard Medical School, Boston, report that patients with high-deductible health insurance plans are significantly more likely to have a delay in diagnosis of metastatic cancer, compared with patients with low-deductible plans.

Using national insurance claims data, the authors conducted an observational study to examine what happened when some workers with employer-based insurance were switched from low-deductible to high-deductible plans, compared with a control group of workers who remained on low-deductible plans.

After the switch, workers shunted into high-deductible plans had a longer time to first diagnosis of a metastatic cancer, indicating delayed detection of advanced disease, compared with controls. The difference translated into a delay in diagnosis of metastatic disease of nearly 5 months, reported Nico Trad, BA, a fourth-year medical student at Dana-Farber Cancer Institute, Boston.

“The takeaway here is that these plans were associated with delayed detection of metastatic cancer. We did not assess the mechanism, but it’s a reasonable assumption to make that increased cost-sharing is having some adverse impacts on people’s willingness to seek care. And although we didn’t study potential impacts, we might anticipate that a delayed diagnosis might also lead to delayed engagement with palliative care,” he said in an oral abstract presentation at the annual meeting of the American Society of Clinical Oncology.

“A delay in initiation of symptom-relieving therapies and a delayed presentation might also lead to greater dissemination of disease throughout the body, which also has the potential to limit therapeutic options,” he added.
 

‘Deductible relief day’

Mr. Trad said that in 2022 more than half of employees are covered by high-deductible health plans, compared with only about 10% in 2006.

This major shift in cost burden coincided with President Joseph Biden’s announcement in early 2022 of the “Cancer Moonshot,” program with the goal of reducing cancer mortality by 50% over the next 25 years.

“Part of that is cancer prevention and control, which involves timely detection of cancer so that we can treat it early and have better outcomes,” he said.

High-deductible health plans ostensibly provide motivation for patients to shop for lower-priced care and avoid unnecessary or low-quality care, but making patients shell out more upfront before their insurance kicks in, while it reduced health care utilization, can also reduce the quality of care, he said.

In 2022, “Deductible Relief Day,” the day in which the average patient has satisfied the deductible and insurance starts to pick up more of the tab, occurred in mid-May, compared with late February in 2006.
 

Insurance claims data

Mr. Trad and colleagues used health insurance claims data from a nationally representative cohort of privately insured patients in a national commercial and Medicare Advantage database. They excluded patients 65 and older who were eligible for Medicare because it does not have high-deductible options.

The study cohort included 345,401 adults from the ages of 18 to 64 whose employers mandated a switch from a low-deductible plan which was defined as $500 or less, to a high-deductible plan defined as $1,000 or more. Controls were 1,654,775 contemporaneous adults whose employers offered only low-deductible plans. Both groups had a 1-year baseline period when all members were enrolled in low deductible plans.

To minimize the possibility of confounding, the investigators matched the participants by age, gender, race/ethnicity, morbidity according to Adjusted Clinical Group score, poverty level, geographic region, employer size, baseline primary cancer, baseline medical and pharmacy costs, and follow-up duration.

During the baseline period, the hazard ratio for time to a first observed metastatic cancer diagnosis in the main cohort, compared with controls, was 0.96 with a nonsignificant P value, indicating no difference in the time to diagnosis between the groups.

During a maximum 13.5 years of follow-up, however, the participants who had been switched after a year to a high-deductible plan had a significantly longer time to first metastatic diagnosis (HR, 0.88; P = .01), indicating delayed diagnosis relative to controls. This difference translated to a delay of 4.6 months associated with the higher out-of-pocket costs plans.

According to a systematic review and meta-analysis published online in 2020, a 1-month delay in treatment for many types of cancer can translate into a 6% to 13% higher risk for death, a risk that continues to increase with further delays.

The investigators acknowledged that the study was limited by the use of retrospective claims-based data, which not contain information on how the patients fared after diagnosis.

“I would say in terms of policy relevance that this really points to the need for new and innovative insurance models that, No. 1, reduce the cost-sharing burden for patients so that they’re not deterred from seeking care, and No. 2, that align rather than contradict the goal of improving population-level survival from cancer,” Mr. Trad said.
 

Further evidence of a flawed system

The study adds to an already strong body of evidence showing that high-deductible plans can have a negative impact on health, said Sara R. Collins, vice president for health care coverage and access at the Commonwealth Fund, a New York–based private foundation dedicated to improving health care.

“This is really the latest evidence on top of years of research that shows that high-deductible health plans lead people to make decisions that are not in the best interest of their health,” said Ms. Collins, who is not affiliated with the study presented at ASCO.

“We have a health care cost problem in the United States that far exceeds that of other high-income countries. Insurers try to solve it by shifting the costs to consumers and using other measures to restrict people’s use of health care, and often needed health care like this. The result is less access to needed care, and long-term adverse health consequences and their associated costs to patients and the health system generally,” she said.

The real driver of health care costs is not utilization, but the prices that insurers and providers negotiate in their service contracts, she explained.

“Prices are the central problem, insurers have control over those prices in their negotiations with providers. So unless we can gain control of that driver, patients are going to continue to suffer unnecessarily from both the short- and long-term effects of insurers who use tools to reduce their access to care,” she said.

In oncology, delayed care may result in a failed opportunity to achieve remission. Delays in diagnosis can result in patients having to undergo more extensive surgery, radiation exposure, or more intensive drug therapy than if their disease had been detected at an early stage.

Now, researchers at Harvard Medical School, Boston, report that patients with high-deductible health insurance plans are significantly more likely to have a delay in diagnosis of metastatic cancer, compared with patients with low-deductible plans.

Using national insurance claims data, the authors conducted an observational study to examine what happened when some workers with employer-based insurance were switched from low-deductible to high-deductible plans, compared with a control group of workers who remained on low-deductible plans.

After the switch, workers shunted into high-deductible plans had a longer time to first diagnosis of a metastatic cancer, indicating delayed detection of advanced disease, compared with controls. The difference translated into a delay in diagnosis of metastatic disease of nearly 5 months, reported Nico Trad, BA, a fourth-year medical student at Dana-Farber Cancer Institute, Boston.

“The takeaway here is that these plans were associated with delayed detection of metastatic cancer. We did not assess the mechanism, but it’s a reasonable assumption to make that increased cost-sharing is having some adverse impacts on people’s willingness to seek care. And although we didn’t study potential impacts, we might anticipate that a delayed diagnosis might also lead to delayed engagement with palliative care,” he said in an oral abstract presentation at the annual meeting of the American Society of Clinical Oncology.

“A delay in initiation of symptom-relieving therapies and a delayed presentation might also lead to greater dissemination of disease throughout the body, which also has the potential to limit therapeutic options,” he added.
 

‘Deductible relief day’

Mr. Trad said that in 2022 more than half of employees are covered by high-deductible health plans, compared with only about 10% in 2006.

This major shift in cost burden coincided with President Joseph Biden’s announcement in early 2022 of the “Cancer Moonshot,” program with the goal of reducing cancer mortality by 50% over the next 25 years.

“Part of that is cancer prevention and control, which involves timely detection of cancer so that we can treat it early and have better outcomes,” he said.

High-deductible health plans ostensibly provide motivation for patients to shop for lower-priced care and avoid unnecessary or low-quality care, but making patients shell out more upfront before their insurance kicks in, while it reduced health care utilization, can also reduce the quality of care, he said.

In 2022, “Deductible Relief Day,” the day in which the average patient has satisfied the deductible and insurance starts to pick up more of the tab, occurred in mid-May, compared with late February in 2006.
 

Insurance claims data

Mr. Trad and colleagues used health insurance claims data from a nationally representative cohort of privately insured patients in a national commercial and Medicare Advantage database. They excluded patients 65 and older who were eligible for Medicare because it does not have high-deductible options.

The study cohort included 345,401 adults from the ages of 18 to 64 whose employers mandated a switch from a low-deductible plan which was defined as $500 or less, to a high-deductible plan defined as $1,000 or more. Controls were 1,654,775 contemporaneous adults whose employers offered only low-deductible plans. Both groups had a 1-year baseline period when all members were enrolled in low deductible plans.

To minimize the possibility of confounding, the investigators matched the participants by age, gender, race/ethnicity, morbidity according to Adjusted Clinical Group score, poverty level, geographic region, employer size, baseline primary cancer, baseline medical and pharmacy costs, and follow-up duration.

During the baseline period, the hazard ratio for time to a first observed metastatic cancer diagnosis in the main cohort, compared with controls, was 0.96 with a nonsignificant P value, indicating no difference in the time to diagnosis between the groups.

During a maximum 13.5 years of follow-up, however, the participants who had been switched after a year to a high-deductible plan had a significantly longer time to first metastatic diagnosis (HR, 0.88; P = .01), indicating delayed diagnosis relative to controls. This difference translated to a delay of 4.6 months associated with the higher out-of-pocket costs plans.

According to a systematic review and meta-analysis published online in 2020, a 1-month delay in treatment for many types of cancer can translate into a 6% to 13% higher risk for death, a risk that continues to increase with further delays.

The investigators acknowledged that the study was limited by the use of retrospective claims-based data, which not contain information on how the patients fared after diagnosis.

“I would say in terms of policy relevance that this really points to the need for new and innovative insurance models that, No. 1, reduce the cost-sharing burden for patients so that they’re not deterred from seeking care, and No. 2, that align rather than contradict the goal of improving population-level survival from cancer,” Mr. Trad said.
 

Further evidence of a flawed system

The study adds to an already strong body of evidence showing that high-deductible plans can have a negative impact on health, said Sara R. Collins, vice president for health care coverage and access at the Commonwealth Fund, a New York–based private foundation dedicated to improving health care.

“This is really the latest evidence on top of years of research that shows that high-deductible health plans lead people to make decisions that are not in the best interest of their health,” said Ms. Collins, who is not affiliated with the study presented at ASCO.

“We have a health care cost problem in the United States that far exceeds that of other high-income countries. Insurers try to solve it by shifting the costs to consumers and using other measures to restrict people’s use of health care, and often needed health care like this. The result is less access to needed care, and long-term adverse health consequences and their associated costs to patients and the health system generally,” she said.

The real driver of health care costs is not utilization, but the prices that insurers and providers negotiate in their service contracts, she explained.

“Prices are the central problem, insurers have control over those prices in their negotiations with providers. So unless we can gain control of that driver, patients are going to continue to suffer unnecessarily from both the short- and long-term effects of insurers who use tools to reduce their access to care,” she said.

In oncology, delayed care may result in a failed opportunity to achieve remission. Delays in diagnosis can result in patients having to undergo more extensive surgery, radiation exposure, or more intensive drug therapy than if their disease had been detected at an early stage.

Now, researchers at Harvard Medical School, Boston, report that patients with high-deductible health insurance plans are significantly more likely to have a delay in diagnosis of metastatic cancer, compared with patients with low-deductible plans.

Using national insurance claims data, the authors conducted an observational study to examine what happened when some workers with employer-based insurance were switched from low-deductible to high-deductible plans, compared with a control group of workers who remained on low-deductible plans.

After the switch, workers shunted into high-deductible plans had a longer time to first diagnosis of a metastatic cancer, indicating delayed detection of advanced disease, compared with controls. The difference translated into a delay in diagnosis of metastatic disease of nearly 5 months, reported Nico Trad, BA, a fourth-year medical student at Dana-Farber Cancer Institute, Boston.

“The takeaway here is that these plans were associated with delayed detection of metastatic cancer. We did not assess the mechanism, but it’s a reasonable assumption to make that increased cost-sharing is having some adverse impacts on people’s willingness to seek care. And although we didn’t study potential impacts, we might anticipate that a delayed diagnosis might also lead to delayed engagement with palliative care,” he said in an oral abstract presentation at the annual meeting of the American Society of Clinical Oncology.

“A delay in initiation of symptom-relieving therapies and a delayed presentation might also lead to greater dissemination of disease throughout the body, which also has the potential to limit therapeutic options,” he added.
 

‘Deductible relief day’

Mr. Trad said that in 2022 more than half of employees are covered by high-deductible health plans, compared with only about 10% in 2006.

This major shift in cost burden coincided with President Joseph Biden’s announcement in early 2022 of the “Cancer Moonshot,” program with the goal of reducing cancer mortality by 50% over the next 25 years.

“Part of that is cancer prevention and control, which involves timely detection of cancer so that we can treat it early and have better outcomes,” he said.

High-deductible health plans ostensibly provide motivation for patients to shop for lower-priced care and avoid unnecessary or low-quality care, but making patients shell out more upfront before their insurance kicks in, while it reduced health care utilization, can also reduce the quality of care, he said.

In 2022, “Deductible Relief Day,” the day in which the average patient has satisfied the deductible and insurance starts to pick up more of the tab, occurred in mid-May, compared with late February in 2006.
 

Insurance claims data

Mr. Trad and colleagues used health insurance claims data from a nationally representative cohort of privately insured patients in a national commercial and Medicare Advantage database. They excluded patients 65 and older who were eligible for Medicare because it does not have high-deductible options.

The study cohort included 345,401 adults from the ages of 18 to 64 whose employers mandated a switch from a low-deductible plan which was defined as $500 or less, to a high-deductible plan defined as $1,000 or more. Controls were 1,654,775 contemporaneous adults whose employers offered only low-deductible plans. Both groups had a 1-year baseline period when all members were enrolled in low deductible plans.

To minimize the possibility of confounding, the investigators matched the participants by age, gender, race/ethnicity, morbidity according to Adjusted Clinical Group score, poverty level, geographic region, employer size, baseline primary cancer, baseline medical and pharmacy costs, and follow-up duration.

During the baseline period, the hazard ratio for time to a first observed metastatic cancer diagnosis in the main cohort, compared with controls, was 0.96 with a nonsignificant P value, indicating no difference in the time to diagnosis between the groups.

During a maximum 13.5 years of follow-up, however, the participants who had been switched after a year to a high-deductible plan had a significantly longer time to first metastatic diagnosis (HR, 0.88; P = .01), indicating delayed diagnosis relative to controls. This difference translated to a delay of 4.6 months associated with the higher out-of-pocket costs plans.

According to a systematic review and meta-analysis published online in 2020, a 1-month delay in treatment for many types of cancer can translate into a 6% to 13% higher risk for death, a risk that continues to increase with further delays.

The investigators acknowledged that the study was limited by the use of retrospective claims-based data, which not contain information on how the patients fared after diagnosis.

“I would say in terms of policy relevance that this really points to the need for new and innovative insurance models that, No. 1, reduce the cost-sharing burden for patients so that they’re not deterred from seeking care, and No. 2, that align rather than contradict the goal of improving population-level survival from cancer,” Mr. Trad said.
 

Further evidence of a flawed system

The study adds to an already strong body of evidence showing that high-deductible plans can have a negative impact on health, said Sara R. Collins, vice president for health care coverage and access at the Commonwealth Fund, a New York–based private foundation dedicated to improving health care.

“This is really the latest evidence on top of years of research that shows that high-deductible health plans lead people to make decisions that are not in the best interest of their health,” said Ms. Collins, who is not affiliated with the study presented at ASCO.

“We have a health care cost problem in the United States that far exceeds that of other high-income countries. Insurers try to solve it by shifting the costs to consumers and using other measures to restrict people’s use of health care, and often needed health care like this. The result is less access to needed care, and long-term adverse health consequences and their associated costs to patients and the health system generally,” she said.

The real driver of health care costs is not utilization, but the prices that insurers and providers negotiate in their service contracts, she explained.

“Prices are the central problem, insurers have control over those prices in their negotiations with providers. So unless we can gain control of that driver, patients are going to continue to suffer unnecessarily from both the short- and long-term effects of insurers who use tools to reduce their access to care,” she said.

Medical management of early pregnancy loss costs less and offers similar quality of life to uterine aspiration, based on data from an analytical model.

Early pregnancy loss (EPL) occurs in more than 1 million women in the United States each year, and many patients are diagnosed before they show symptoms, wrote Divyah Nagendra, MD, of Cambridge Health Alliance, Mass., and colleagues.

A 2018 study showed that medical management of EPL with mifepristone added to misoprostol increased effectiveness and reduced the need for additional medication or subsequent uterine procedures, but the cost of mifepristone is perceived as a barrier, and the cost-effectiveness of its use, compared with surgical or expectant management, has not been well studied, the researchers noted.

“We already know that adding mifepristone to the medical management of early pregnancy loss increases the effectiveness of the regimen,” coauthor Courtney A. Schreiber, MD, of the University of Pennsylvania, Philadelphia, said in an interview. “Procedural uterine aspiration is highly effective as well, so patients and providers may consider the cost when deciding on a treatment strategy,” she added.

“If medication management is preferred by many patients, decreases the need to access in-person clinical care during a pandemic, and is found to be cost-effective, clinicians and policymakers should increase efforts to improve mifepristone availability and reduce access burdens,” the researchers wrote.

In a study published in the American Journal of Obstetrics & Gynecology, the researchers created a decision-analytic model using data from published literature and the Pregnancy Failure Regiments Trial (PreFaiR) to compare office-based uterine aspiration to medical management with mifepristone pretreatment followed by misoprostol for EPL.

The PrFaiR study randomized 300 women who experienced EPL before 12 weeks’ gestation to medication management with 800 mcg misoprostol vaginally, with or without pretreatment of 200 mg mifeprestone orally. The average age of the participants was 30.7 years, and demographics were similar between the groups.

The researchers used the PrFaiR data for medical management and patient-level data from published literature for uterine aspiration.

The primary outcome was the cost per quality-adjusted life year (QALY) gained. QALY was based on a modified utility score from the published literature. Effectiveness was based on QALY gained and the rate of complete expulsion of the gestational sac without additional intervention.

Overall, the mean costs per person were significantly higher for uterine aspiration, compared with medical management ($828 vs. $661, P = .004). Uterine aspiration was significantly more effective for complete gestational sac expulsion (97.3% vs. 83.8%, P = .0001). However, the QALYs were significantly higher for medical management, compared with uterine aspiration (0.082 vs. 0.079, P < .0001).

Cost-effectiveness was greater for medical management from a health care sector perspective, with lower costs and higher QALYs than uterine aspiration, the researchers noted.

They also evaluated the effect of mifepristone pretreatment on cost-effectiveness and found that medical management would remain cost effective, compared with uterine aspiration even if uterine aspiration procedures decreased in cost and mifepristone increased in cost, and even if medication management had a decreased completion rate and utility score, compared with uterine aspiration.

“Our analysis demonstrates that the incremental cost-effectiveness ratio (ICER) for medical management is well below the maximum willingness-to-pay threshold of approximately $100,000 per QALY gained,” the researchers wrote in their discussion of the findings.
 

Potential savings, uncertain access

Despite the potential savings and patient benefits, access to mifepristone remains a barrier, the researchers said.

Although the FDA lifted some restrictions on mifepristone in 2021 in the wake of the ongoing COVID-19 pandemic, the effect of new abortion-related restrictions remains to be seen.

The study findings were limited by several factors, including the use of 2018 National Medicare reimbursement rates to calculate costs, though actual costs vary by region and payer, the researchers noted. Other limitations include variations in cost of mifepristone by region and time and the differences in data sources between the uterine aspiration and medical management groups. More research is needed to assess QALYs for early pregnancy loss to establish standard measures and to assess the societal perspective of ESL as well as the health care perspective, they added.

However, the current results support medical management of EPL with mifepristone pretreatment followed by misoprostol as a “high-value care alternative” to office-based uterine aspiration, they said. “Increasing access to mifepristone and eliminating unnecessary restrictions will improve early pregnancy care,” they concluded.

“Given how effective procedural management is, we were slightly surprised that medical management remains cost effective,” Dr. Schreiber said in an interview.

Looking ahead in the wake of new restrictions on use for abortion, “patients may have difficulty accessing either medical or procedural management for early pregnancy loss,” Dr. Schreiber noted. “We support the accessibility of all evidence-based care and hope that our data will help overcome perceived financial barriers,” she said. Additional research needs include improved implementation and access to evidence-based early pregnancy loss care, she added.
 

Reasons to lift regulations

“Given the recent overturning of Roe v. Wade, any medications that are associated with abortion have increased scrutiny, especially mifepristone and misoprostol, even though these medications are also used for managing early pregnancy loss,” Sarah W. Prager, MD, of the University of Washington, Seattle, said in an interview. “Demonstrating that medication management of EPL with mifepristone/misoprostol is less expensive and has increased QALYs associated with it is yet another reason to deregulate mifepristone so it can also be more accessible for management of EPL,” said Dr. Prager, who was not involved in the study.

Dr. Prager said she was not surprised by the findings, as effective medication should be less expensive than a procedure. “I would caution that the increased QALYs found in this study should not be interpreted as a reason to restrict surgical management of EPL but to increase access also to medication management, even though medication has a slightly lower rate of complete gestational sac expulsion,” she noted. “Mode of management should be up to the patient, unless there is a clear medical reason for one or the other.”

Going forward, “the FDA has it in its power to remove the REMS, which would immediately make mifepristone a medication that can be prescribed through a pharmacy and therefore much more available,” said Dr. Prager. “Restrictions for both medication and surgical management of EPL will likely increase in states where abortion is illegal, and it could possibly lead to patients having less choice as to mode of management,” she explained.

“There are many studies showing that all modes of EPL management are safe and effective and should be supported with respect to patient choice,” Dr. Prager noted. “There are also substantial data supporting the overall safety of mifepristone, and there are no scientific or medical data suggesting the REMS increases safety in any way. Frankly, there are no good, evidence-based reasons to continue to keep the REMS in place,” she said.

The study was supported by the National Institute of Child Health and Human Development of the National Institutes of Health and a Society of Family Planning Research Fund Midcareer Mentor Award. The researchers had no financial conflicts to disclose. Dr. Prager had no financial conflicts to disclose and serves on the Editorial Advisory Board of Ob.Gyn. News.

obnews@mdedge.com

Medical management of early pregnancy loss costs less and offers similar quality of life to uterine aspiration, based on data from an analytical model.

Early pregnancy loss (EPL) occurs in more than 1 million women in the United States each year, and many patients are diagnosed before they show symptoms, wrote Divyah Nagendra, MD, of Cambridge Health Alliance, Mass., and colleagues.

A 2018 study showed that medical management of EPL with mifepristone added to misoprostol increased effectiveness and reduced the need for additional medication or subsequent uterine procedures, but the cost of mifepristone is perceived as a barrier, and the cost-effectiveness of its use, compared with surgical or expectant management, has not been well studied, the researchers noted.

“We already know that adding mifepristone to the medical management of early pregnancy loss increases the effectiveness of the regimen,” coauthor Courtney A. Schreiber, MD, of the University of Pennsylvania, Philadelphia, said in an interview. “Procedural uterine aspiration is highly effective as well, so patients and providers may consider the cost when deciding on a treatment strategy,” she added.

“If medication management is preferred by many patients, decreases the need to access in-person clinical care during a pandemic, and is found to be cost-effective, clinicians and policymakers should increase efforts to improve mifepristone availability and reduce access burdens,” the researchers wrote.

In a study published in the American Journal of Obstetrics & Gynecology, the researchers created a decision-analytic model using data from published literature and the Pregnancy Failure Regiments Trial (PreFaiR) to compare office-based uterine aspiration to medical management with mifepristone pretreatment followed by misoprostol for EPL.

The PrFaiR study randomized 300 women who experienced EPL before 12 weeks’ gestation to medication management with 800 mcg misoprostol vaginally, with or without pretreatment of 200 mg mifeprestone orally. The average age of the participants was 30.7 years, and demographics were similar between the groups.

The researchers used the PrFaiR data for medical management and patient-level data from published literature for uterine aspiration.

The primary outcome was the cost per quality-adjusted life year (QALY) gained. QALY was based on a modified utility score from the published literature. Effectiveness was based on QALY gained and the rate of complete expulsion of the gestational sac without additional intervention.

Overall, the mean costs per person were significantly higher for uterine aspiration, compared with medical management ($828 vs. $661, P = .004). Uterine aspiration was significantly more effective for complete gestational sac expulsion (97.3% vs. 83.8%, P = .0001). However, the QALYs were significantly higher for medical management, compared with uterine aspiration (0.082 vs. 0.079, P < .0001).

Cost-effectiveness was greater for medical management from a health care sector perspective, with lower costs and higher QALYs than uterine aspiration, the researchers noted.

They also evaluated the effect of mifepristone pretreatment on cost-effectiveness and found that medical management would remain cost effective, compared with uterine aspiration even if uterine aspiration procedures decreased in cost and mifepristone increased in cost, and even if medication management had a decreased completion rate and utility score, compared with uterine aspiration.

“Our analysis demonstrates that the incremental cost-effectiveness ratio (ICER) for medical management is well below the maximum willingness-to-pay threshold of approximately $100,000 per QALY gained,” the researchers wrote in their discussion of the findings.
 

Potential savings, uncertain access

Despite the potential savings and patient benefits, access to mifepristone remains a barrier, the researchers said.

Although the FDA lifted some restrictions on mifepristone in 2021 in the wake of the ongoing COVID-19 pandemic, the effect of new abortion-related restrictions remains to be seen.

The study findings were limited by several factors, including the use of 2018 National Medicare reimbursement rates to calculate costs, though actual costs vary by region and payer, the researchers noted. Other limitations include variations in cost of mifepristone by region and time and the differences in data sources between the uterine aspiration and medical management groups. More research is needed to assess QALYs for early pregnancy loss to establish standard measures and to assess the societal perspective of ESL as well as the health care perspective, they added.

However, the current results support medical management of EPL with mifepristone pretreatment followed by misoprostol as a “high-value care alternative” to office-based uterine aspiration, they said. “Increasing access to mifepristone and eliminating unnecessary restrictions will improve early pregnancy care,” they concluded.

“Given how effective procedural management is, we were slightly surprised that medical management remains cost effective,” Dr. Schreiber said in an interview.

Looking ahead in the wake of new restrictions on use for abortion, “patients may have difficulty accessing either medical or procedural management for early pregnancy loss,” Dr. Schreiber noted. “We support the accessibility of all evidence-based care and hope that our data will help overcome perceived financial barriers,” she said. Additional research needs include improved implementation and access to evidence-based early pregnancy loss care, she added.
 

Reasons to lift regulations

“Given the recent overturning of Roe v. Wade, any medications that are associated with abortion have increased scrutiny, especially mifepristone and misoprostol, even though these medications are also used for managing early pregnancy loss,” Sarah W. Prager, MD, of the University of Washington, Seattle, said in an interview. “Demonstrating that medication management of EPL with mifepristone/misoprostol is less expensive and has increased QALYs associated with it is yet another reason to deregulate mifepristone so it can also be more accessible for management of EPL,” said Dr. Prager, who was not involved in the study.

Dr. Prager said she was not surprised by the findings, as effective medication should be less expensive than a procedure. “I would caution that the increased QALYs found in this study should not be interpreted as a reason to restrict surgical management of EPL but to increase access also to medication management, even though medication has a slightly lower rate of complete gestational sac expulsion,” she noted. “Mode of management should be up to the patient, unless there is a clear medical reason for one or the other.”

Going forward, “the FDA has it in its power to remove the REMS, which would immediately make mifepristone a medication that can be prescribed through a pharmacy and therefore much more available,” said Dr. Prager. “Restrictions for both medication and surgical management of EPL will likely increase in states where abortion is illegal, and it could possibly lead to patients having less choice as to mode of management,” she explained.

“There are many studies showing that all modes of EPL management are safe and effective and should be supported with respect to patient choice,” Dr. Prager noted. “There are also substantial data supporting the overall safety of mifepristone, and there are no scientific or medical data suggesting the REMS increases safety in any way. Frankly, there are no good, evidence-based reasons to continue to keep the REMS in place,” she said.

The study was supported by the National Institute of Child Health and Human Development of the National Institutes of Health and a Society of Family Planning Research Fund Midcareer Mentor Award. The researchers had no financial conflicts to disclose. Dr. Prager had no financial conflicts to disclose and serves on the Editorial Advisory Board of Ob.Gyn. News.

obnews@mdedge.com

Medical management of early pregnancy loss costs less and offers similar quality of life to uterine aspiration, based on data from an analytical model.

Early pregnancy loss (EPL) occurs in more than 1 million women in the United States each year, and many patients are diagnosed before they show symptoms, wrote Divyah Nagendra, MD, of Cambridge Health Alliance, Mass., and colleagues.

A 2018 study showed that medical management of EPL with mifepristone added to misoprostol increased effectiveness and reduced the need for additional medication or subsequent uterine procedures, but the cost of mifepristone is perceived as a barrier, and the cost-effectiveness of its use, compared with surgical or expectant management, has not been well studied, the researchers noted.

“We already know that adding mifepristone to the medical management of early pregnancy loss increases the effectiveness of the regimen,” coauthor Courtney A. Schreiber, MD, of the University of Pennsylvania, Philadelphia, said in an interview. “Procedural uterine aspiration is highly effective as well, so patients and providers may consider the cost when deciding on a treatment strategy,” she added.

“If medication management is preferred by many patients, decreases the need to access in-person clinical care during a pandemic, and is found to be cost-effective, clinicians and policymakers should increase efforts to improve mifepristone availability and reduce access burdens,” the researchers wrote.

In a study published in the American Journal of Obstetrics & Gynecology, the researchers created a decision-analytic model using data from published literature and the Pregnancy Failure Regiments Trial (PreFaiR) to compare office-based uterine aspiration to medical management with mifepristone pretreatment followed by misoprostol for EPL.

The PrFaiR study randomized 300 women who experienced EPL before 12 weeks’ gestation to medication management with 800 mcg misoprostol vaginally, with or without pretreatment of 200 mg mifeprestone orally. The average age of the participants was 30.7 years, and demographics were similar between the groups.

The researchers used the PrFaiR data for medical management and patient-level data from published literature for uterine aspiration.

The primary outcome was the cost per quality-adjusted life year (QALY) gained. QALY was based on a modified utility score from the published literature. Effectiveness was based on QALY gained and the rate of complete expulsion of the gestational sac without additional intervention.

Overall, the mean costs per person were significantly higher for uterine aspiration, compared with medical management ($828 vs. $661, P = .004). Uterine aspiration was significantly more effective for complete gestational sac expulsion (97.3% vs. 83.8%, P = .0001). However, the QALYs were significantly higher for medical management, compared with uterine aspiration (0.082 vs. 0.079, P < .0001).

Cost-effectiveness was greater for medical management from a health care sector perspective, with lower costs and higher QALYs than uterine aspiration, the researchers noted.

They also evaluated the effect of mifepristone pretreatment on cost-effectiveness and found that medical management would remain cost effective, compared with uterine aspiration even if uterine aspiration procedures decreased in cost and mifepristone increased in cost, and even if medication management had a decreased completion rate and utility score, compared with uterine aspiration.

“Our analysis demonstrates that the incremental cost-effectiveness ratio (ICER) for medical management is well below the maximum willingness-to-pay threshold of approximately $100,000 per QALY gained,” the researchers wrote in their discussion of the findings.
 

Potential savings, uncertain access

Despite the potential savings and patient benefits, access to mifepristone remains a barrier, the researchers said.

Although the FDA lifted some restrictions on mifepristone in 2021 in the wake of the ongoing COVID-19 pandemic, the effect of new abortion-related restrictions remains to be seen.

The study findings were limited by several factors, including the use of 2018 National Medicare reimbursement rates to calculate costs, though actual costs vary by region and payer, the researchers noted. Other limitations include variations in cost of mifepristone by region and time and the differences in data sources between the uterine aspiration and medical management groups. More research is needed to assess QALYs for early pregnancy loss to establish standard measures and to assess the societal perspective of ESL as well as the health care perspective, they added.

However, the current results support medical management of EPL with mifepristone pretreatment followed by misoprostol as a “high-value care alternative” to office-based uterine aspiration, they said. “Increasing access to mifepristone and eliminating unnecessary restrictions will improve early pregnancy care,” they concluded.

“Given how effective procedural management is, we were slightly surprised that medical management remains cost effective,” Dr. Schreiber said in an interview.

Looking ahead in the wake of new restrictions on use for abortion, “patients may have difficulty accessing either medical or procedural management for early pregnancy loss,” Dr. Schreiber noted. “We support the accessibility of all evidence-based care and hope that our data will help overcome perceived financial barriers,” she said. Additional research needs include improved implementation and access to evidence-based early pregnancy loss care, she added.
 

Reasons to lift regulations

“Given the recent overturning of Roe v. Wade, any medications that are associated with abortion have increased scrutiny, especially mifepristone and misoprostol, even though these medications are also used for managing early pregnancy loss,” Sarah W. Prager, MD, of the University of Washington, Seattle, said in an interview. “Demonstrating that medication management of EPL with mifepristone/misoprostol is less expensive and has increased QALYs associated with it is yet another reason to deregulate mifepristone so it can also be more accessible for management of EPL,” said Dr. Prager, who was not involved in the study.

Dr. Prager said she was not surprised by the findings, as effective medication should be less expensive than a procedure. “I would caution that the increased QALYs found in this study should not be interpreted as a reason to restrict surgical management of EPL but to increase access also to medication management, even though medication has a slightly lower rate of complete gestational sac expulsion,” she noted. “Mode of management should be up to the patient, unless there is a clear medical reason for one or the other.”

Going forward, “the FDA has it in its power to remove the REMS, which would immediately make mifepristone a medication that can be prescribed through a pharmacy and therefore much more available,” said Dr. Prager. “Restrictions for both medication and surgical management of EPL will likely increase in states where abortion is illegal, and it could possibly lead to patients having less choice as to mode of management,” she explained.

“There are many studies showing that all modes of EPL management are safe and effective and should be supported with respect to patient choice,” Dr. Prager noted. “There are also substantial data supporting the overall safety of mifepristone, and there are no scientific or medical data suggesting the REMS increases safety in any way. Frankly, there are no good, evidence-based reasons to continue to keep the REMS in place,” she said.

The study was supported by the National Institute of Child Health and Human Development of the National Institutes of Health and a Society of Family Planning Research Fund Midcareer Mentor Award. The researchers had no financial conflicts to disclose. Dr. Prager had no financial conflicts to disclose and serves on the Editorial Advisory Board of Ob.Gyn. News.

obnews@mdedge.com